Form 10-Q

Large accelerated filer

Accelerated filer

Non-accelerated filer

¨ (Do not check if a smaller reporting company)

Smaller reporting company

0001193125-12-344196.txt : 20120808 0001193125-12-344196.hdr.sgml : 20120808 20120808164414 ACCESSION NUMBER: 0001193125-12-344196 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20120630 FILED AS OF DATE: 20120808 DATE AS OF CHANGE: 20120808 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INTERMUNE INC CENTRAL INDEX KEY: 0001087432 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943296648 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-29801 FILM NUMBER: 121017359 BUSINESS ADDRESS: STREET 1: 3280 BAYSHORE STREET 2: BLVD CITY: BRISBANE STATE: CA ZIP: 94005 BUSINESS PHONE: 415 466 2200 MAIL ADDRESS: STREET 1: 3280 BAYSHORE BLVD CITY: BRISBANE STATE: CA ZIP: 94005 FORMER COMPANY: FORMER CONFORMED NAME: INTERMUNE PHARMACEUTICALS INC DATE OF NAME CHANGE: 20000121 10-Q 1 d370181d10q.htm FORM 10-Q Form 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

Form 10-Q

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2012

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 0-29801

InterMune, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

94-3296648

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

3280 Bayshore Blvd., Brisbane, California 94005

(Address of principal executive offices, including zip code)

(415) 466-2200

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period than the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

As of July 31, 2012, there were 65,739,097 outstanding shares of common stock, par value $0.001 per share, of InterMune, Inc.

INTERMUNE, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2012

INDEX


Item	Page

PART I. FINANCIAL INFORMATION

1. Financial Statements (unaudited):		3
a. Condensed Consolidated Balance Sheets at June 30, 2012 and December 31, 2011		3
b. Condensed Consolidated Statements of Operations for the three and six-months ended June 30, 2012 and 2011		4
c. Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six-months ended June 30, 2012 and 2011		5
d. Condensed Consolidated Statements of Cash Flows for the six-months ended June 30, 2012 and 2011		6
e. Notes to Condensed Consolidated Financial Statements		7
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		16
3. Quantitative and Qualitative Disclosures About Market Risk		23
4. Controls and Procedures		24

PART II. OTHER INFORMATION

1. Legal Proceedings		25
1A. Risk Factors		27
6. Exhibits		46
Signatures		48

PART I — FINANCIAL INFORMATION

Item 1.

Financial Statements

INTERMUNE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	June 30, 2012			December 31, 2011
	(Unaudited, in thousands)
ASSETS
Current assets:
Cash and cash equivalents	$	135,339		$	177,428
Available-for-sale securities		258,390			247,682
Accounts receivable, net of allowances of $20 and $56 at June 30, 2012 and December 31, 2011, respectively		4,702			3,764
Inventories		9,152			6,220
Prepaid expenses and other current assets		6,064			8,044

Total current assets		413,647			443,138
Property and equipment, net		4,118			2,341
Acquired product rights		18,750			19,250
Other assets (includes restricted cash of $1,674 at June 30, 2012 and $1,427 at December 31, 2011)		7,588			7,894

Total assets	$	444,103		$	472,623

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	12,282		$	10,068
Accrued compensation		7,577			9,044
Other accrued liabilities		21,217			14,979

Total current liabilities		41,076			34,091
Convertible notes		240,250			240,250
Other long term liabilities		185			114
Commitments and contingencies
Stockholders’ equity:
Common stock		66			65
Additional paid-in capital		1,155,311			1,144,947
Accumulated other comprehensive income		1,221			1,025
Accumulated deficit		(994,006	)		(947,869	)

Total stockholders’ equity		162,592			198,168

Total liabilities and stockholders’ equity	$	444,103		$	472,623

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


	Three Months Ended June 30,						Six Months Ended June 30,
	2012			2011			2012			2011
	(Unaudited, in thousands, except per share data)
Revenue, net
Esbriet^®	$	5,538		$	—		$	10,418		$	—
Collaboration revenue		—			1,329			—			2,629

Total revenue, net		5,538			1,329			10,418			2,629
Costs and expenses:
Cost of goods sold		3,323			—			4,183			—
Research and development		25,166			20,084			48,378			36,922
Selling, general and administrative		25,642			21,638			51,926			39,009

Total costs and expenses		54,131			41,722			104,487			75,931
Loss from operations		(48,593	)		(40,393	)		(94,069	)		(73,302	)
Other income (expense):
Interest income		159			121			304			259
Interest expense		(2,237	)		(1,086	)		(4,442	)		(2,873	)
Other income (expense)		(139	)		11			(1,124	)		(95	)

Loss from operations before income taxes		(50,810	)		(41,347	)		(99,331	)		(76,011	)
Income tax expense		69			—			134			—

Loss from continuing operations		(50,879	)		(41,347	)		(99,465	)		(76,011	)
Discontinued operations:
Income from discontinued operations		37			1,453			1,993			4,014
Gain on sale of discontinued operations		51,335			—			51,335			—

Income from discontinued operations		51,372			1,453			53,328			4,014

Net income (loss)	$	493		$	(39,894	)	$	(46,137	)	$	(71,997	)

Basic and diluted net income (loss) per common share:
Continuing operations	$	(0.78	)	$	(0.70	)	$	(1.53	)	$	(1.32	)
Discontinued operations	$	0.79		$	0.02		$	0.82		$	0.07

	$	0.01		$	(0.68	)	$	(0.71	)	$	(1.25	)

Shares used in computing basic net income (loss) per share		64,943			58,924			64,858			57,657

Shares used in computing diluted net income (loss) per share		65,193			58,924			64,858			57,657

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME


	Three Months Ended June 30,						Six Months Ended June 30,
	2012			2011			2012			2011
Net income (loss)	$	493		$	(39,894	)	$	(46,137	)	$	(71,997	)
Other comprehensive income:
Cumulative foreign currency translation adjustment		(33	)		(20	)		219			(51	)
Unrealized gain (loss) on available-for-sale securities		(30	)		28			(23	)		114

Comprehensive income (loss)	$	430		$	(39,886	)	$	(45,941	)	$	(71,934	)

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


	Six Months Ended June 30,
	2012			2011
	(Unaudited, in thousands)
Cash flows used in operating activities:
Net loss	$	(46,137	)	$	(71,997	)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on sale of discontinued operations		(51,335	)		—
Amortization and depreciation		1,401			1,727
Stock-based compensation expense		9,103			8,949
Net realized gains on sales of available for sale securities		—			(15	)
Other		290			(260	)
Changes in operating assets and liabilities:
Accounts receivable, net		(938	)		42
Inventories		(4,661	)		(3,790	)
Other assets		1,878			(1,878	)
Accounts payable and accrued compensation		747			3,541
Other accrued liabilities		4,302			1,344

Net cash used in operating activities		(85,350	)		(62,337	)

Cash flows from investing activities:
Proceeds from the divestiture of Actimmune		55,000			—
Acquisition of product rights		—			(20,000	)
Purchases of property and equipment		(2,270	)		(321	)
Purchases of available-for-sale securities		(240,345	)		(143,246	)
Sales of available-for-sale securities		84,533			37,937
Maturities of available-for-sale securities		145,081			106,684

Net cash provided by (used in) investing activities		41,999			(18,946	)
Cash flows from financing activities:
Proceeds from issuance of common stock under employee stock benefit plans		1,262			33,194

Net cash provided by financing activities		1,262			33,194

Net decrease in cash and cash equivalents		(42,089	)		(48,089	)
Cash and cash equivalents at beginning of period		177,428			110,584

Cash and cash equivalents at end of period	$	135,339		$	62,495

Supplemental disclosure of cash flow information:
Non-cash financing activities:
Issuance of common stock in exchange for convertible debt	$	—		$	44,963

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1.	ORGANIZATION

Overview

We are a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. Pulmonology is the field of medicine concerned with the diagnosis and treatment of lung conditions. We have an advanced-stage product candidate in pulmonology, pirfenidone, that was granted marketing authorization effective February 2011 in all 27 member countries of the European Union (“EU”) for the treatment of adults with mild to moderate idiopathic pulmonary fibrosis (“IPF”). In September 2011, we launched commercial sales of pirfenidone in Germany under the trade name Esbriet^®, and we are continuing to prepare for the commercial launch of Esbriet^® in the other countries in the EU. We are also pursuing the registration of pirfenidone to treat IPF in the United States. After reviewing various regulatory and clinical development options and following our discussions with the United States Food and Drug Administration (“FDA”), we commenced an additional pivotal Phase 3 clinical study of pirfenidone in IPF in July 2011, known as the ASCEND trial, which is expected to be fully enrolled around the end of 2012 with results in the first half of 2014. The results of the ASCEND trial are expected to supplement the existing Phase 3 clinical study data from our CAPACITY clinical trials to support the registration of pirfenidone to treat IPF in the United States.

2.	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or any other future period and should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC).

Principles of consolidation

The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Holdings Ltd. and InterMune UK & I Ltd., along with our other subsidiaries located in Canada, the United Kingdom, Germany, France, Switzerland, Spain, Italy, the Netherlands, Sweden and Austria. All inter-company balances and transactions have been eliminated.

Use of estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates and assumptions.

We evaluate our estimates and assumptions on an ongoing basis, including those related to our allowances for doubtful accounts, product returns, chargebacks, cash discounts and rebates; excess/obsolete inventories; acquired product rights, the effects of inventory purchase commitments on inventory; certain accrued clinical and preclinical expenses and contingent liabilities and provision for income taxes. We base our estimates on historical experience and on various other specific assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Inventory valuation

Inventories are stated at the lower of cost or market. Cost is determined by the specific identification method. Inventories were $9.2 million and $6.2 million at June 30, 2012 and December 31, 2011, respectively, and consisted solely of Esbriet at June 30, 2012.

Because of the long lead times required to manufacture Esbriet, we enter into purchase obligations to satisfy our estimated inventory requirements. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current as well as committed purchases. We are also required to make judgments as to the expiration dates since the products are not usable beyond their expiration date. As part of our excess inventory assessment for Esbriet, we also consider the expiration dates of future manufactured quantities under these purchase obligations.

We incurred approximately $0.2 million for inventory writedowns during the quarter ended June 30, 2012. As of June 30, 2012, we had firm commitments to purchase approximately $0.6 million of Esbriet inventory.

Foreign Currency Exchange Risk

In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes.

Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. Management does not expect material losses as a result of defaults by counterparties.

Acquired Product Rights

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA or the European Commission (“EC”) for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product, which we currently estimate to be 20 years for Esbriet. We assess this estimate regularly during the amortization period and adjust the asset value and/or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA or EC for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development costs.

Revenue recognition and revenue reserves

We recognize revenue from product sales generally upon delivery when title passes to a credit-worthy customer and record provisions for estimated returns, rebates, chargebacks and cash discounts against revenue. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.

Our European revenue from sales of Esbriet began in September 2011 and through June 30, 2012, has primarily been limited to revenue derived from sales in Germany. We only ship product upon receipt of valid orders from customers such as pharmacies and hospitals which are in turn a result of actual patient prescriptions. Pursuant to German Medicinal Products Law, a customer has no right to return the product; therefore we have not established a reserve for product returns, though we have established a reserve for the mandatory rebate as allowed under the applicable German health care regulations.

Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

In December 2010, we entered into a new agreement with Roche that focused on research to identify and develop next-generation protease inhibitors for the treatment of Hepatitis C virus. Under terms of the agreement, Roche funded all research costs related to the programs for the period from July 1, 2010 through June 30, 2011, the effective term of the research program. During 2011, we received $2.6 million from Roche as a reimbursement for research services performed which has been recorded as collaboration revenue. We will also be entitled to receive certain milestones and royalties in connection with the continued development and commercialization by Roche of any licensed compounds resulting from the research program.

Research and development expenses

Research and development (“R&D”) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations (“CRO”), licensing fees, acquired intellectual property with no alternative future use and facility and administrative expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2 and Phase 3 clinical trials. These costs are a significant component of our research and development expenses.

We accrue costs for clinical trial activities performed by contract research organizations and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities using available information; however, if we underestimate activity levels associated with various studies at a given point in time, we could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. We charge all such costs to R&D expenses. Non-refundable advance payments are capitalized and expensed as the related goods are delivered or services are performed.

Net income (loss) per share

We compute basic net income (loss) per share by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period, as adjusted. We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net income per share by dividing the net income for the period by the weighted average number of common and potential common shares outstanding during the period. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method. For the computation of net loss per share we exclude dilutive securities, composed of potential common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, because of their anti-dilutive effect.

The shares excluded were as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2012		2011		2012		2011
Options		3,294		3,935		5,283		3,935
Shares issuable upon conversion of convertible notes		9,384		4,502		9,384		4,502

The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2012			2011			2012			2011
Denominator:
Weighted-average shares of common stock outstanding		65,468			59,889			65,357			58,660
Less: weighted-average shares subject to repurchase		(525	)		(965	)		(499	)		(1,003	)

Weighted-average shares used in computing net income (loss) per share – basic		64,943			58,924			64,858			57,657

Effect of dilutive securities (stock options, treasury stock method)		250			—			—			—

Weighted-average shares used in computing net income (loss) per share – diluted		65,193			58,924			64,858			57,657

Stock-Based Compensation

The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2012		2011		2012		2011
Cost of goods sold	$	54	$	—	$	107	$	—
Research and development		1,135		1,008		2,440		3,100
Selling, general and administrative		3,181		2,762		6,556		5,849

Total stock-based compensation expense	$	4,370	$	3,770	$	9,103	$	8,949

Under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718-10, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the vesting period for that portion of the award that is ultimately expected to vest. In order to estimate the value of share-based awards, we use the Black-Scholes model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility, the expected term of the award and the estimated forfeiture rate.

Recent Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, Presentation of Comprehensive Income. This ASU gives an entity the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. We retrospectively adopted ASU No. 2011-05 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

In May 2011, the FASB issued ASU No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This ASU is the result of joint efforts by the FASB and International Accounting Standards Board to develop a single, converged fair value framework. While this ASU is largely consistent with existing fair value measurement principles in U.S. GAAP, it expands ASC No. 820, Fair Value Measurement existing disclosure requirements for fair value measurements and makes other amendments. Many of these amendments were made to eliminate unnecessary wording differences between U.S. GAAP and International Financial Reporting Standards, which could change how fair value measurement guidance in ASC 820 is applied. We prospectively adopted ASU No. 2011-04 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

3.	DISCONTINUED OPERATIONS

On June 19, 2012, we completed the divestiture of our worldwide development and commercialization rights to the pharmaceutical product containing Interferon Gamma-1b sold by us under the tradename Actimmune^® for $55.0 million in cash, plus certain conditional royalty payments for a period of two years following the closing (the transaction is referred to herein as the “Asset Sale”). The Asset Sale was consummated pursuant to the terms of the Asset Purchase Agreement, dated as of May 17, 2012, by and among InterMune and Vidara Therapeutics International Limited, an Irish company, Vidara Therapeutics Holdings LLC, a Delaware limited liability company and Vidara Therapeutics Research Limited, an Irish company, as amended on June 18, 2012. The operating results of our Actimmune activities have been reclassified as discontinued operations for all periods presented.

Results of Discontinued Operations

Summary operating results for the discontinued operations are as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2012		2011		2012		2011
Actimmune revenue, net	$	2,571	$	4,909	$	6,627	$	9,961
Costs and expenses:
Cost of goods sold		2,448		3,359		4,474		5,645
General and administrative		86		97		160		302

Total costs and expenses		2,534		3,456		4,634		5,947

Income from discontinued operations	$	37	$	1,453	$	1,993	$	4,014

Gain on Sale of Discontinued Operations

The gain on sale of discontinued operations is calculated as follows (in thousands):


Cash proceeds received from sale	$	55,000
Less Actimmune assets sold:
Inventories, net		(1,729	)
Less direct transaction costs:
Legal and financial		(1,936	)

Gain	$	51,335

4.	FAIR VALUE

In accordance with portions of ASC Topic No. 820, the following table represents the Company’s fair value hierarchy for its financial assets (cash, cash equivalents and investments, including accrued interest of approximately $0.5 million and $0.7 million, respectively) measured at fair value on a recurring basis as of June 30, 2012 and December 31, 2011 (in thousands):


June 30, 2012	Level 1		Level 2		Level 3		Total
Money market funds	$	47,026	$	—	$	—	$	47,026
Obligations of government-sponsored enterprises		—		151,428		—		151,428
Corporate debt securities		—		32,223		—		32,223
Commercial paper		—		55,934		—		55,934

Total	$	47,026	$	239,585	$	—	$	286,611


December 31, 2011	Level 1		Level 2		Level 3		Total
Money market funds	$	82,693	$	—	$	—	$	82,693
Obligations of government-sponsored enterprises		—		140,887		—		140,887
Corporate debt securities		—		31,815		—		31,815
Commercial paper		—		36,985		—		36,985
Municipal bond		—		4,510		—		4,510

Total	$	82,693	$	214,197	$	—	$	296,890

The fair value of Level 1 assets have been determined using quoted prices in active markets for identical assets or liabilities.

To estimate the fair value of Level 2 debt securities as of June 30, 2012 and December 31, 2011, our primary pricing service relied on inputs from multiple industry-recognized pricing sources to determine the price for each investment. In addition, they performed reasonableness testing of their prices on a daily basis by comparing them to the prices reported by our custodians as well as prior day prices. If the price difference fell outside of tolerable levels, they investigated the cause and resolved the pricing issue. Based on a review of the results of this analysis, we utilized our primary pricing service for all Level 2 debt securities as none of these securities tested outside of the tolerable levels.

As of June 30, 2012 and December 31, 2011, our primary pricing service inputs for Level 2 cash equivalents (bonds), U.S. government sponsored enterprises, municipal obligations and corporate bonds consisted of market prices from a variety of industry standard data providers, security master files from large financial institutions and other third-party sources. These multiple market prices were used by our primary pricing service as inputs into a distribution-curve based algorithm to determine the daily market value.

As of June 30, 2012 and December 31, 2011, our primary pricing service inputs for Level 2 cash equivalents, commercial paper and corporate debt securities, consisted of dynamic and static security characteristics information obtained from several independent security characteristic sources. The dynamic inputs such as credit rating, factor and variable-rate, were updated daily. The static characteristics included inputs such as day count and first coupon upon initial security creation. These securities were typically priced via mathematical calculations reliant on these observable inputs.

The fair value of our long-term convertible debt is based on quoted prices for those instruments using readily available market information. As of June 30, 2012, the fair value of our $155.3 million 2.5% convertible senior notes due 2018 (“2018 Notes”) was $125.0 million and the fair value of our $85.0 million 5.0% convertible senior notes due 2015 (“2015 Notes”) was $92.0 million. As of December 31, 2011, the fair value of our 2018 Notes was $112.6 million and the fair value of our 2015 Notes was $84.1 million.

5.	AVAILABLE-FOR-SALE INVESTMENTS

The following is a summary of our available-for-sale investments as of June 30, 2012 and December 31, 2011 (in thousands):


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
June 30, 2012
Obligations of government-sponsored enterprises	$	151,442	$	18	$	(32	)	$	151,428
Money market funds		47,026		—		—			47,026
Commercial paper		55,931		3		—			55,934
Corporate debt securities		32,168		58		(3	)		32,223

Total	$	286,567	$	79	$	(35	)	$	286,611


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
December 31, 2011
Obligations of government-sponsored enterprises	$	140,848	$	48	$	(9	)	$	140,887
Money market funds		82,693		—		—			82,693
Commercial paper		36,983		2		—			36,985
Corporate debt securities		31,788		35		(8	)		31,815
Municipal bond		4,510		—		—			4,510

Total	$	296,822	$	85	$	(17	)	$	296,890

Realized gains and losses and declines in value, judged to be other than temporary, on available-for-sale securities are included in other income (expense) for the three- and six-months ended June 30, 2012 and 2011. Realized gains were calculated based on the specific identification method and were not material for each of the three- and six-month periods ended June 30, 2012 and June 30, 2011. Unrealized holding gains and losses on securities classified as available-for-sale are recorded in accumulated other comprehensive income.

The following is a summary of the amortized cost and estimated fair value of available-for-sale securities at June 30, 2012 by contractual maturity (in thousands):


	June 30, 2012
	Amortized Cost		Fair Value
Mature in less than one year	$	241,665	$	241,697
Mature in one to three years		44,902		44,914
Mature in over three years		—		—

Total	$	286,567	$	286,611

6.	DERIVATIVE INSTRUMENTS

We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity. Our net gains from entering into derivative financial instruments not designated as hedges in the first six months of 2012 was approximately $0.2 million. The notional value of our outstanding currency hedges at June 30, 2012 was approximately 13.0 million euros and the fair value of these outstanding derivatives at June 30, 2012 was zero.

Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. We do not generally require collateral to be pledged under these agreements. Management does not expect material losses as a result of defaults by counterparties.

7.	ACQUIRED PRODUCT RIGHTS

Marnac, Inc./KDL GmbH (Pirfenidone)

In 2002, we licensed from Marnac and its co-licensor, KDL, their worldwide rights (excluding Japan, Korea and Taiwan) to develop and commercialize pirfenidone for all fibrotic diseases, including renal, liver and pulmonary fibrosis. Under the agreement terms, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and up to 9% royalty payments. Effective November 2007, we entered into asset purchase agreements with Marnac and KDL whereby we effectively terminated the prior license agreement by purchasing, among other things, the pirfenidone-related assets covered by such prior license agreement. Under the terms of the asset purchase agreements, we made payments of approximately $13.7 million. We also made a milestone payment of $13.5 million in March 2009 in connection with our decision to proceed with regulatory approval for pirfenidone. In March 2011, we received authorization to market Esbriet (pirfenidone) in the European Union and made a milestone payment of $20.0 million in the aggregate to Marnac and KDL and have capitalized such payment as acquired product rights. This asset is being amortized to cost of goods sold over the estimated useful life of Esbriet of twenty years and we incurred approximately $0.5 million of amortization expense in the first six months of 2012. Amortization expense for each of the next five years is expected to be $1.0 million per year. A future contingent payment of up to an additional $20.0 million is required to be made by us only if positive Phase 3 data and product approval in the United States is achieved. The asset purchase agreements do

not affect the rights to pirfenidone in Japan, Korea and Taiwan, which rights are licensed by Marnac and KDL to Shionogi & Company LTD (“Shionogi”). Since the original 2002 license agreement has been effectively terminated as a result of our acquisition of such pirfenidone-related assets from Marnac and KDL, we no longer have milestone or royalty obligations thereunder.

The following table reflects our acquired product rights under these agreements (in thousands):


	June 30, 2012		December 31, 2011
Gross carrying amount	$	20,000	$	20,000
Accumulated amortization		1,250		750

Net carrying amount	$	18,750	$	19,250

8.	COMMITMENTS AND CONTINGENCIES

Contingent Payments

We may be required to make contingent milestone payments to the owners of our licensed products or the suppliers of our drug compounds in accordance with our license, commercialization and collaboration agreements in the aggregate amount of $32.5 million if all of the milestones per the agreements are achieved. These milestones include development, regulatory approval, commercialization and sales milestones. Of the remaining $32.5 million in future aggregate milestone payments, $20.0 million in contingent payments would be made by us only if positive Phase 3 data and product approval in the United States is achieved for pirfenidone. Included in the $32.5 million in future aggregate milestone payments are aggregate milestone payments of $11.3 million payable to Array and Novartis, of which Roche has agreed to reimburse us in connection with our sale of danoprevir to Roche.

Indemnity Agreement

On or about March 22, 2000, we entered into an Indemnity Agreement with W. Scott Harkonen M.D., who served as the Company’s chief executive officer until June 30, 2003. The Indemnity Agreement obligates us to hold harmless and indemnify Dr. Harkonen against expenses (including attorneys’ fees), witness fees, damages, judgments, fines and amounts paid in settlement and any other amounts Dr. Harkonen becomes legally obligated to pay because of any claim or claims made against him in connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal, arbitrational, administrative or investigative, to which Dr. Harkonen is a party by reason of the fact that he was a director, officer, employee or other agent of the Company. The Indemnity Agreement establishes exceptions to our indemnification obligation, including but not limited to claims “on account of [Dr. Harkonen’s] conduct that is established by a final judgment as knowingly fraudulent or deliberately dishonest or that constituted willful misconduct,” claims “on account of [Dr. Harkonen’s] conduct that is established by a final judgment as constituting a breach of [Dr. Harkonen’s] duty of loyalty to the Corporation or resulting in any personal profit or advantage to which [Dr. Harkonen] was not legally entitled,” and claims “for which payment is actually made to [Dr. Harkonen] under a valid and collectible insurance policy.” The Indemnity Agreement, however, obligates us to advance all expenses, including attorneys’ fees, incurred by Dr. Harkonen in connection with such proceedings, subject to an undertaking by Dr. Harkonen to repay said amounts if it shall be determined ultimately that he is not entitled to be indemnified by the Company.

Dr. Harkonen was named as a defendant in certain civil action lawsuits instituted against us where the various complaints that were filed alleged that we fraudulently misrepresented the medical benefits of Actimmune for the treatment of IPF and promoted Actimmune for IPF. Ultimately, these complaints were dismissed. However, Dr. Harkonen also became the target of the investigation by the U.S. Department of Justice regarding the promotion and marketing of Actimmune. On March 18, 2008, a federal grand jury indicted Dr. Harkonen on two felony counts related to alleged improper promotion and marketing of Actimmune during the time Dr. Harkonen was employed by us (the “Criminal Action”). The trial in the criminal case resulted in a jury verdict on September 29, 2009, finding Dr. Harkonen guilty of one count of wire fraud related to a press release issued on August 28, 2002, and acquitting him of a second count of a misbranding charge brought under the Federal Food, Drug, and Cosmetic Act. On April 13, 2011, the Court denied Dr. Harkonen’s post-trial motions and sentenced Dr. Harkonen to three years of probation, including six months of home detention, 200 hours of community service and a fine of $20,000. The Court’s Judgment was filed on April 18, 2011. Dr. Harkonen filed a timely notice of appeal and currently is appealing his conviction and sentence. The government has indicated that it will pursue a cross-appeal regarding Dr. Harkonen’s sentence. Briefing is underway. Under the terms of the Indemnity Agreement, we have an obligation to indemnify Dr. Harkonen for reasonable legal fees and costs incurred in connection with defending this action, including the proceedings on appeal.

Prior to December 2008, insurers that issued directors & officers (“D&O”) liability insurance to the Company had advanced all of Dr. Harkonen’s expenses, including attorneys’ fees, incurred in the civil action lawsuits and Criminal Action. Those insurers included National Union Fire Insurance Company of Pittsburgh, PA (“AIG”), Underwriters at Lloyd’s, London (“Lloyd’s”), and Continental Casualty Company (“CNA”). On November 19, 2008, however, the insurer that issued a $5 million D&O insurance policy providing coverage excess of the monetary limits of coverage provided by AIG, Lloyd’s and CNA, Arch Specialty Insurance Company (“Arch”), advised the Company that the limits of the underlying coverage were expected to be depleted by approximately December 15, 2008; that Arch “disclaim[ed] coverage” based on misstatements and misrepresentations allegedly made by Dr. Harkonen in documents provided in the application for the Arch policy and the underlying Lloyd’s policy; and that, based on that disclaimer, Arch would not be advancing any of Dr. Harkonen’s expenses, including attorneys’ fees, incurred in the civil action lawsuits and Criminal Action.

As a result of Arch’s disclaimer of coverage and refusal to advance expenses, including attorneys’ fees, the Company had, as of approximately December 15, 2008, become obligated to advance such expenses incurred by Dr. Harkonen in the civil action lawsuits and Criminal Action.

On January 13, 2009, we submitted to the American Arbitration Association (“AAA”) a Demand for Arbitration, InterMune, Inc. v. Arch Specialty Insurance Co., No. 74 194 01128 08 JEMO. Dr. Harkonen also is a party to the Arbitration. The Demand for Arbitration sought an award compelling Arch to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and the Criminal Action, and to advance other former officers’ legal fees and costs incurred in relation to the Department of Justice investigation.

The matter was heard by the arbitration panel and on May 29, 2009, the arbitration panel issued an Interim Arbitration Award granting our request for a partial award requiring Arch to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and Criminal Action. Arch subsequently advanced such fees and costs, including fees and costs previously paid by the Company. The question whether Arch ultimately will be required to cover the advanced fees and costs or, instead, may recoup those fees and costs as not covered by its policy, has not been determined. Unless and until the arbitration panel rules that such fees and costs are not covered, Arch remains obligated to advance such fees and costs. At this time, we believe no change to the status of the interim Arbitration Award or to the application of the D&O liability insurance in general has occurred due to the trial court judgment, and, therefore, we have not recorded any accrued liabilities associated with this matter.

In late 2009, Arch advised us that Arch had exhausted the $5.0 million limit of liability of the Arch D&O insurance policy, and that defense cost invoices submitted to Arch collectively exceed the Arch policy’s limit. The Company therefore advised the insurer that issued a $5.0 million D&O insurance policy providing coverage for the excess of the monetary limits of coverage provided by Arch, Old Republic Insurance Company (“Old Republic”), that the limits of the underlying coverage had been depleted, and we submitted invoices for legal services rendered on behalf of Dr. Harkonen and other individuals who were targets of the U.S. Department of Justice’s investigation to Old Republic for payment. Old Republic agreed to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and Criminal Action, but declined to reimburse us for payments made on behalf of other individuals who were targets of the U.S. Department of Justice’s investigation. In mid-2010, Old Republic advised us that Dr. Harkonen’s defense fees and costs had exhausted the $5 million limit of the Old Republic insurance policy as of the second quarter of 2010. There is no additional insurance coverage available to cover the cost of Dr. Harkonen’s continuing defense. Defense fees and costs incurred over and above this final $5 million of insurance coverage therefore are, in the absence of any available insurance, to be advanced by us pursuant to the terms of the Indemnity Agreement. We expect amounts to be paid by us to continue into the future until the Criminal Action is finally adjudicated, however we are unable to predict what our total liability could be with any degree of certainty.

Shionogi

In March 2012, following discussions between Shionogi & Co., Ltd (“Shionogi”) and us, Shionogi demanded that we agree that Shionogi is entitled to royalty payments on our net sales of pirfenidone (Esbriet^®) in Europe, based on Shionogi’s interpretation of our May 2004 agreement with Shionogi (as amended). On July 5, 2012, Shionogi filed a complaint against us in the United States District Court for the Northern District of California. Shionogi’s complaint alleges principally that we breached that agreement with Shionogi governing the exchange and use of certain documents and information relating to the parties’ respective clinical trials of pirfenidone. The complaint alleges that we breached the agreement by utilizing certain of Shionogi’s information in our Marketing Authorization Application and other submissions for pirfenidone with the EMA and then failing to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. In the alternative, the complaint alleges that, if we did not use Shionogi’s information in a way that would trigger a royalty obligation under the agreement, we had an obligation to do so as an exclusive licensee. Shionogi is seeking,

among other things, unspecified monetary damages and a declaration that we are obligated to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. While we strongly disagree that we owe any such royalties and intend to defend our position vigorously, an unfavorable outcome in the litigation with Shionogi could require that we pay royalties or make other payments to Shionogi.

9.	DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION

We have determined that, in accordance with ASC Topic No. 280, we operate in one segment, because operating results are reported only on an aggregate basis to our chief operating decision makers. We currently market and sell Esbriet in Europe for the treatment of IPF, of which substantially all revenue is derived from Germany since the initial launch in September 2011. Revenue from sales of Actimmune has been reclassified to discontinued operations for all periods presented and therefore is not included in the figures below. See also note 3.

Our revenue and trade receivables are concentrated with a few customers. We perform credit evaluations on our customers’ financial condition and limit the amount of credit extended. However, we generally do not require collateral on accounts receivable. Concentrations of credit risk, with respect to accounts receivable, exist to the extent of amounts presented in the financial statements. One customer represented approximately 26% and 12% of total trade accounts receivable at June 30, 2012 and December 31, 2011, respectively. No other customer represented more than 10% of accounts receivable at June 30, 2012 or December 31, 2011.

Revenue from customers representing 10% or more of total product revenue during the six month periods ended June 30, 2012 and 2011, was as follows:


	Six Months Ended June 30,
Customer	2012			2011
Phoenix Pharmahandel GmbH & Co.		25	%		—	%

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Forward-Looking Statements

This Quarterly Report on Form 10-Q (the Report) contains certain information regarding our financial projections, plans and strategies that are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements involve substantial risks and uncertainty. You can identify these statements by forward-looking words such as “may,” “will,” “expect,” “intend,” “anticipate,” “believe,” “estimate,” “plan,” “could,” “should,” “continue” or the negative of such terms or similar words or expressions. These forward-looking statements may also use different phrases.

We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements, which are subject to risks, uncertainties and assumptions about us, may include, among other things, statements which address our strategy and operating performance and events or developments that we expect or anticipate will occur in the future, including, but not limited to, statements in the discussions about:

•

product and product candidate development;

•

the market or markets for our products or product candidates;

•

the ability of our products to treat patients in our markets;

•

the ability to achieve certain pricing and reimbursement levels for our product in various countries in the European Union and elsewhere;

•

timing and expectations of the timing of enrollment in our ASCEND clinical trial, expected enrollment completion dates and announcement of clinical results from our ASCEND clinical trial;

•

timing and expectations of when our products or product candidates may be marketed;

•

opportunities to establish development or commercial alliances;

•

commercial launch preparations, including the timing of launches in the various European Union jurisdictions and the implementation of the infrastructure required for the commercial launches;

•

the scope and enforceability of our intellectual property rights, including the anticipated durations of patent protection and marketing exclusivity in the European Union, United States and other jurisdictions, and including claims that we or our collaborators may infringe third party intellectual property rights or otherwise be required to pay license fees and or royalties under such third party rights;

•

our expectations regarding the complaint Shionogi filed against us alleging principally that we breached our agreement with Shionogi governing the exchange and use of certain documents and information relating to the parties’ respective clinical trials of pirfenidone;

•

governmental regulation and approval;

•

requirement of additional funding to complete research and development and commercialize products;

•

liquidity and sufficiency of our cash resources;

•

future revenue, including those from product sales and collaborations, adequacy of revenue reserve levels, future expenses, future financial performance and trends;

•

our future research and development expenses and other expenses; and

•

our operational and legal risks.

You should also consider carefully the statements under the heading “Risk Factors” below, which address additional factors that could cause our results to differ from those set forth in the forward-looking statements. Any forward-looking statements are qualified in their entirety by reference to the factors discussed in this Report, including those discussed in this Report under the heading “Risk Factors” below. Because of the factors referred to above, as well as the factors discussed in this Report under the heading “Risk Factors” below, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statement. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. When used in the Report, unless otherwise indicated, “InterMune,” “we,” “our” and “us” refers to InterMune, Inc. and its consolidated subsidiaries.

Critical Accounting Policies

Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable. These estimates are the basis for our judgments about the carrying values of assets and liabilities, which in turn may impact our reported revenue and expenses. Actual results may differ from these estimates under different assumptions or conditions.

An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimate that are reasonably likely to occur periodically, could materially change the financial statements. We believe there have been no significant changes during the three month period ended June 30, 2012 to the items that we disclosed as our critical accounting policies and estimates under Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Annual Report on Form 10-K for the year ended December 31, 2011.

Company Overview

We are a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. We have an advanced-stage product candidate in pulmonology, pirfenidone, that was granted marketing authorization effective February 2011 in all 27 member countries of the European Union (“EU”) for the treatment of adults with mild to moderate idiopathic pulmonary fibrosis (“IPF”).

On June 19, 2012, we completed the divestiture of our worldwide development and commercialization rights to the pharmaceutical product containing Interferon Gamma-1b sold by us under the tradename Actimmune^® for $55.0 million in cash, plus certain conditional royalty payments for a period of two years following the closing. Such divestiture was consummated pursuant to the terms of the Asset Purchase Agreement, dated as of May 17, 2012, that we entered into with Vidara Therapeutics International Limited, an Irish company, Vidara Therapeutics Holdings LLC, a Delaware limited liability company and Vidara Therapeutics Research Limited, an Irish company. The operating results of our Actimmune activities have been reclassified as discontinued operations for all periods presented.

Pirfenidone (Esbriet^®)

Pirfenidone is an orally active, small molecule compound under development for the treatment of idiopathic pulmonary fibrosis. In September 2011, we launched commercial sales of pirfenidone in Germany under the trade name Esbriet^®. In addition, in the first half of 2012, we launched Esbriet^® in Austria, Denmark, Norway and Luxembourg, and we are continuing to prepare for the commercial launch of Esbriet^® in other countries in Europe. Subject to EU country reimbursement timelines, we currently plan to conclude pricing and reimbursement discussions for Esbriet in France, Spain and Italy during the fourth quarter of 2012 and launch in those countries as soon as practicable after concluding discussions. We currently plan to conclude the discussions with the authorities in the United Kingdom in the first quarter of 2013, and, depending on the outcome of such discussions, make Esbriet available in the United Kingdom as soon as practicable thereafter if appropriate. In addition to launches in the remaining so called “Top 5” EU countries, we expect to launch Esbriet in in Belgium, the Netherlands, Finland, and Sweden in the second half of 2012 and in Ireland in the first quarter of 2013.

To support our commercialization efforts of Esbriet in Europe, we are currently investing in the establishment of a commercial infrastructure within the EU, including an increase to our employee headcount in that region. On December 17, 2010, we announced several additions to our senior leadership team in support of our commercialization efforts as well as announcing the establishment of our European headquarters in Reinach, Switzerland, subsequently moved to Muttenz, Switzerland in early 2012. In December 2010, we transferred all of our non-U.S. rights to research, develop and commercialize pirfenidone for IPF to our wholly-owned Swiss subsidiary, InterMune International AG. Based on our current intellectual property portfolio, we expect to have exclusive rights to sell pirfenidone within the European Union through 2030.

In 2011, we initiated an additional Phase 3 clinical study to evaluate pirfenidone in IPF known as ASCEND in an effort to support approval of pirfenidone for the treatment IPF in the United States. In April 2012, we revised the timeline for our expected completion of clinical enrollment from the end of the second quarter of 2012 to around the end of 2012. As a result of the later projected date for completion of enrollment, we now expect to report data from the ASCEND trial in the first half of 2014.

Results of Operations

Revenue

Total revenue was $5.5 million and $1.3 million for the three-month periods ended June 30, 2012 and 2011, respectively, representing an increase of 317%. For the six-month periods ended June 30, 2012 and 2011, total revenue was $10.4 million and $2.6 million, respectively, representing an increase of 296%. Revenue for the three- and six-months ended June 30, 2012 consists solely of Esbriet product sales, primarily in Germany, following the launch in that country in September 2011. Revenue for the three- and six-month periods ended June 30, 2011 consists solely of collaboration revenue from Roche as a reimbursement for research services performed.

Cost of goods sold

Cost of goods sold included product manufacturing costs, distribution costs, inventory write-downs and amortization of acquired product rights. Cost of goods sold were $3.3 million and $4.2 million for the three- and six-month periods ended June 30, 2012, respectively, and consists solely of costs related to Esbriet. For the three- and six-month periods ended June 30, 2011, no costs of goods sold were recorded as Esbriet was launched in Germany in September 2011.

Research and development expenses

Research and development (R&D) expenses were $25.2 million and $20.1 million for the three-month periods ended June 30, 2012 and 2011, respectively, representing an increase of $5.1 million, or 25%. R&D expenses were $48.4 million and $36.9 million for the six-month periods ended June 30, 2012 and 2011, respectively, representing an increase of $11.5 million, or 31%. The increases primarily reflect the commencement of the ASCEND trial in July 2011, our additional pivotal Phase 3 clinical study of pirfenidone in IPF.

The following tables list our current product development programs and the research and development expenses recognized in connection with each program during the indicated periods. The category title “Programs—Non-specific” is comprised of facilities, personnel costs that are not allocated to a specific development program or discontinued programs, and $2.4 million and $3.1 million of stock-based compensation in 2012 and 2011, respectively. Our management reviews each of these program categories in evaluating our business. For a discussion of the risks and uncertainties associated with developing our products, as well as the risks and uncertainties associated with potential commercialization of our product candidates, see the Risk Factors below including those under the headings “Risks Related to the Development of Our Products and Product Candidates.”

The following chart shows the status of our product development programs as of June 30, 2012:

Preclinical

Phase I

Phase II

Phase III

Pulmonology

Pirfenidone—Idiopathic pulmonary fibrosis

Hepatology^**

Next generation protease inhibitors

NS5A inhibitors

Our development program expenses for the six-month periods ended June 30, 2012 and 2011 were as follows (in thousands):


	Six Months Ended June 30,
Development Program	2012		2011
Pulmonology	$	38,395	$	22,509
Hepatology^**		—		2,533
Programs — Non-specific		9,983		11,880

Total	$	48,378	$	36,922

*	Granted marketing authorization for Esbriet in the European Union effective February 2011.

**	No further investments in hepatology are planned.

Historically, the largest component of our total operating expense was our ongoing investment in research and development and, in particular, the clinical development of our product pipeline. The process of conducting the clinical research necessary to obtain FDA approval is costly and time consuming. Current FDA requirements for a new human drug to be marketed in the United States include:

•

the successful conclusion of preclinical laboratory and animal tests, if appropriate, to gain preliminary information on the product’s safety;

•

the submission of an IND with the FDA to conduct human clinical trials for drugs;

•

the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and

•

the submission by a company and acceptance and approval by the FDA of an NDA or BLA for a drug product to allow commercial distribution of the drug.

In light of the factors mentioned above, we consider the active management and development of our clinical pipeline to be crucial to our long-term success. The actual probability of success for each candidate and clinical program may be impacted by a variety of factors, including, among others, the quality of the candidate, the validity of the target and disease indication, early clinical data, investment in the program, competition, manufacturing capability and commercial viability. Due to these factors, it is difficult to give accurate guidance on the anticipated proportion of our research and development investments or the future cash inflows from these programs. In addition, due to these same factors and others, we are unable to reasonably estimate the efforts needed and, therefore, the costs we will incur to complete any of our projects or the estimated time to complete such projects. We are also unable to provide costs incurred for specific research and development projects within each major development program as well as the cumulative costs incurred to date given that we do not maintain specific financial records to this level of detail. However, a substantial majority of our resources have been invested in our pirfenidone project and, prior to our divesture, former danoprevir project in order to advance them into Phase 3 and Phase 2 clinical development, respectively. The remaining projects within our hepatology research programs are dormant and no longer receive any funding.

The actual probability of success for each candidate and clinical program may be impacted by a variety of factors, including, among others, the quality of the candidate, the validity of the target and disease indication, early clinical data, investment in the program, competition, manufacturing capability and overall safety and efficacy profile as ultimately decided upon by the FDA. Due to these factors, we believe it is difficult to give accurate guidance on the anticipated proportion of our research and development investments or the future cash inflows from these programs. In addition, due to these same factors and others, we are unable to reasonably estimate the efforts needed and, therefore, the costs we will incur to complete any of our projects or the estimated time to complete such projects.

Selling, general and administrative expenses

Selling, general and administrative (SG&A) expenses were $25.6 million for the three-month period ended June 30, 2012 and $21.6 million for the same period in 2011, an increase of $4.0 million, or 19%. SG&A expenses were $51.9 million for the six-month period ended June 30, 2012 and $39.0 million for the same period in 2011, an increase of $12.9 million, or 33%. The increased spending for the three- and six-month periods ended June 30, 2012 compared with the same periods in 2011 is attributed to the creation of our European infrastructure and investments in the pre-commercial launch and commercial launch of Esbriet in Europe, including but not limited to additional headcount.

Interest income

Interest income was $0.2 million for the three-month period ended June 30, 2012, compared to $0.1 million for the three-month period ended June 30, 2011, and $0.3 million for each of the six-month periods ended June 30, 2012 and June 30, 2011, reflecting modest yields on our cash and short-term investments resulting from our conservative investment portfolio.

Interest expense

Interest expense increased to $2.2 million in the three-month period ended June 30, 2012 from $1.1 million for the three-month period ended June 30, 2011. Interest expense also increased to $4.4 million in the six-month period ended June 30, 2012 from $2.9 million for the six-month period ended June 30, 2011. These increases are the result of our issuance in September 2011 of $155.3 million aggregate principal amount of 2.5% convertible senior notes due 2018.

Discontinued operations

The $51.3 million gain from discontinued operations reflects the divestiture of our worldwide development and commercialization rights to Actimmune for $55.0 million in cash, partially offset by transaction costs and the value of inventory. The components of the income from discontinued operations include Actimmune revenue, net, as well as cost of goods sold and certain specific general and administrative costs for each of the three- and six-month periods ended June 30, 2012 and June 30, 2011.

Liquidity and Capital Resources

At June 30, 2012, we had available cash, cash equivalents and available-for-sale securities of $393.7 million compared to $425.1 million at December 31, 2011. The decrease of $31.4 million was primarily driven by the use of cash for our operations, partially offset by the $55.0 million in proceeds received from our divestiture of Actimmune in June 2012. In addition, in September 2011, we completed a registered underwritten public offering of 4.6 million shares of our common stock and a concurrent registered underwritten public offering of $155.3 million aggregate principal amount of 2.5% convertible senior notes due 2018. The aggregate net proceeds from these concurrent offerings were approximately $255.0 million. The proceeds from these offerings and our Actimmune divestiture are being used in the commercial launch of Esbriet in the EU, conducting our ASCEND trial as well as for general corporate purposes. We believe that our cash, cash equivalents and available-for-sale securities as of June 30, 2012 are sufficient to fund our operations, as currently contemplated, for at least the next 12 months. Some of these available cash and cash equivalents are held in accounts managed by third party financial institutions and consist of invested cash and cash in our core operating accounts. The invested cash is invested in interest bearing funds managed by third party financial institutions. We can provide no assurances that access to our invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets. In addition, at any point in time we could have balances that exceed the Federal Deposit Insurance Corporation insurance limits. While we monitor the cash balances in our operating accounts on a regular basis, these cash balances could be impacted and we may be unable to access our cash if the underlying financial institutions fail or if we become subject to other adverse conditions in the financial markets. To date we have not experienced a lack of access to cash in any of our third party financial institution accounts.

The primary objective of our investment activities is to preserve principal while at the same time maximize yields without significantly increasing risk. To achieve this objective, we invest our excess cash in debt instruments of the U.S. federal and state governments and their agencies and high-quality corporate issuers, and, by policy, restrict our exposure by imposing concentration limits and credit worthiness requirements for all corporate issuers.

Operating Activities

Cash used in operating activities was $85.4 million during the six-month period ended June 30, 2012, comprised primarily of a net loss of $46.1 million and an increase in inventories of $4.7 million, primarily consisting of purchases and production of Esbriet inventory. Details concerning the loss from operations can be found above in this Report under the heading “Results of Operations.”

Investing Activities

Cash provided by investing activities was $42.0 million during the six-month period ended June 30, 2012, comprised primarily of proceeds from the divestiture of Actimmune, as well as sales and maturities of available-for-sale securities of $229.6 million, partially offset by purchases of $240.3 million of available-for-sale securities.

Financing Activities

Cash provided by financing activities of $1.3 million for the six-month period ended June 30, 2012 was due to the issuance of stock to our employees under our employee benefit plans.

We expect to incur net losses in the near term as we continue our preparations for the commercial launch of and commercially launch Esbriet in other countries in the European Union, continue the development of pirfenidone for approval in the United States with the ongoing ASCEND study, continue our research in the area of orphan fibrotic diseases, and continue to grow our operational capabilities. We believe that our existing cash, cash equivalents and available-for-sale securities, together with anticipated cash flows

from sales of Esbriet will be sufficient to fund our operating expenses, debt obligations and capital requirements under our current business plan through at least the next 12 months. This forward-looking statement involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed under “Item 1A. Risk Factors.” This forward-looking statement is also based upon our current plans and assumptions, which may change, and our capital requirements, which may increase in future periods. Our future capital requirements will depend on many factors, including, but not limited to:

•

capital requirements related to our commercial launch of Esbriet in Germany and preparations for the commercial launch of Esbriet in other European Union jurisdictions, including the expansion of our commercial infrastructure and related personnel and facility expenses;

•

the timing and financial requirements of the ongoing Phase 3 clinical study of pirfenidone in the U.S. (ASCEND);

•

sales of Esbriet or any of our product candidates in development that receive commercial approval;

•

pricing and reimbursement from third-payors for Esbriet;

•

our ability to partner our programs or products;

•

the progress of our research and development efforts;

•

the scope and results of preclinical studies and clinical trials;

•

the costs, timing and outcome of regulatory reviews;

•

determinations as to the commercial potential of our product candidates in development;

•

the costs, timing and outcome of our legal proceeding with Shionogi;

•

the pace of expansion of administrative expenses;

•

the status of competitive products and competitive barriers to entry;

•

the establishment and maintenance of manufacturing capacity through third-party manufacturing agreements;

•

the establishment of collaborative relationships with other companies;

•

the payments of annual interest on our long-term debt; and

•

the timing and size of payments we may receive from potential collaboration agreements.

As a result, we may require substantial additional capital and may attempt to raise additional funds through equity or debt financings, collaborative arrangements with corporate partners or from other sources. We have no commitments for such fund raising activities at this time. Furthermore, additional funding may not be available to finance our operations when needed or, if available, the terms for obtaining such funds may not be favorable or may result in dilution to our stockholders.

Off-Balance Sheet Arrangements

With the exception of standard operating leases, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.

Recent Accounting Pronouncements

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

The securities in our investment portfolio are not leveraged, are classified as available-for-sale and are, due to their short-term nature, subject to minimal interest rate risk. We currently do not hedge interest rate exposure. Because of the short-term maturities of our investments, we do not believe that a change in market rates would have a significant negative impact on the value of our investment portfolio.

The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk. To achieve this objective, we maintain our portfolio of cash equivalents and short-term and long-term investments in a variety of securities, including obligations of U.S. government-sponsored enterprises, corporate notes and bonds, commercial paper, and money market funds. These securities are classified as available for sale and consequently are recorded on the balance sheet at fair value with unrealized gains or losses reported as a separate component of accumulated other comprehensive income. Substantially all investments mature within approximately two years from the date of purchase. Our holdings of the securities of any one issuer, except obligations of U.S. government-sponsored enterprises, do not exceed 10% of the portfolio. If interest rates rise, the market value of our investments may decline, which could result in a realized loss if we are forced to sell an investment before its scheduled maturity. We do not utilize derivative financial instruments to manage our interest rate risks.

The table below presents the original principal amounts and weighted-average interest rates by year of maturity for our investment portfolio as of June 30, 2012 by effective maturity (in millions, except percentages):


	2012			2013			2014		2015			2016 and Beyond			Total			Fair Value at June 30, 2012
Assets:
Available-for-sale securities	$	148.9		$	137.9			—		—			—		$	286.8		$	286.6
Average interest rate		0.2	%		0.4	%		—		—			—			0.3	%		—
Liabilities:
5.0% convertible senior notes due 2015		—			—			—	$	85.0			—		$	85.0		$	92.0
Average interest rate		—			—			—		5.0	%		—			5.0	%		—
2.5% convertible senior notes due 2018		—			—			—		—		$	155.3		$	155.3		$	125.0
Average interest rate		—			—			—		—			2.5	%		2.5	%		—

Foreign Currency Market Risk

Item 4.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

As of the end of the period covered by this quarterly report on Form 10-Q, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures, or “disclosure controls.” This controls evaluation was performed under the supervision and with the participation of management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO). Disclosure controls are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended (the Exchange Act), such as this Report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls are also designed to reasonably ensure that such information is accumulated and communicated to our management, including the CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure. Based upon the controls evaluation, our CEO and CFO have concluded that, as a result of the matters discussed below with respect to our internal control over financial reporting, our disclosure controls were effective at the reasonable assurance level as of the end of the period covered by this Report.

Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our internal control system was designed to provide reasonable assurance to management and our board of directors regarding the reliability of financial reporting and preparation of published financial statements in accordance with generally accepted accounting principles.

Management assessed our internal control over financial reporting as of June 30, 2012, the end of the period covered by this report. As a result of this assessment, management has concluded that our internal control over financial reporting was effective as of June 30, 2012. In making our assessment of internal control over financial reporting, we used the criteria issued in the report Internal Control-Integrated Framework by the Committee of Sponsoring Organizations of the Treadway Commission.

Changes in Internal Control Over Financial Reporting

There have been no changes to our internal control over financial reporting during the three months ended June 30, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

CEO and CFO Certifications

Attached as exhibits to this Report, there are “Certifications” of the CEO and the CFO required by Rule 13a-14(a) of the Securities Exchange Act of 1934, or the Rule 13a-14(a) Certifications. This Controls and Procedures section of the Report includes the information concerning the controls evaluation referred to in the Rule 13a-14(a) Certifications and it should be read in conjunction with the Rule 13a-14(a) Certifications for a more complete understanding of the topics presented.

Limitations on the effectiveness of controls.

Our management, including our CEO and CFO, does not expect that our control systems will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within InterMune have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree

of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our CEO and CFO have concluded, based on their evaluation as of the end of the period covered by this Report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.

PART II — OTHER INFORMATION

Item 1.

Legal Proceedings.

Indemnity Agreement

Shionogi

In March 2012, following discussions between Shionogi & Co., Ltd (“Shionogi”) and us, Shionogi demanded that we agree that Shionogi is entitled to royalty payments on our sales of pirfenidone (Esbriet^®) in Europe, based on Shionogi’s interpretation of our May 2004 agreement with Shionogi (as amended). On July 5, 2012, Shionogi filed a complaint against us in the United States District Court for the Northern District of California. Shionogi’s complaint alleges principally that we breached that agreement with Shionogi governing the exchange and use of certain documents and information relating to the parties’ respective clinical trials of pirfenidone. The complaint alleges that we breached the agreement by utilizing certain of Shionogi’s information in our Marketing Authorization Application and other submissions for pirfenidone with the EMA and then failing to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. In the alternative, the complaint alleges that, if we did not use Shionogi’s information in a way that would trigger a royalty obligation under the agreement, we had an obligation to do so as an exclusive licensee. Shionogi is seeking, among other things, unspecified monetary damages and a declaration that we are obligated to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. We strongly disagree with Shionogi’s claims and intend to defend our position vigorously.

ITEM 1A.

RISK FACTORS

An investment in our common stock is risky. Stockholders and potential purchasers of shares of our stock should carefully consider the following risk factors in addition to other information and risk factors in this Quarterly Report. We are identifying these risk factors as important factors that could cause our actual results to differ materially from those contained in any written or oral forward-looking statements made by or on behalf of InterMune. We are relying upon the safe harbor for all forward-looking statements in this Report, and any such statements made by or on behalf of InterMune are qualified by reference to the following cautionary statements, as well as to those set forth elsewhere in this Quarterly Report.

Risks Related to Our Dependence on Pirfenidone

We are dependent on the commercial success of Esbriet (pirfenidone) for the treatment of IPF in the European Union and on the regulatory approval of pirfenidone for the treatment of IPF in the United States and other countries, which may never occur.

We commenced operations in 1998 and have incurred significant losses to date. Prior to launching commercial sales of Esbriet in Germany in September 2011 and in Austria, Denmark, Norway and Luxembourg in the first half of 2012, our revenue was limited primarily to sales of Actimmune derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of IPF and from upfront license fees and milestone payments in connection with our collaboration with Roche. In March 2007, we discontinued our development of Actimmune for treatment of IPF. In October 2010, we sold to Roche all of our worldwide rights to danoprevir for $175.0 million in cash, and terminated our collaboration with Roche from which we had derived our collaboration revenue. As a result, our future success is currently dependent on the regulatory and commercial success of pirfenidone for the treatment of IPF in Europe and the United States. In March 2011, Esbriet (pirfenidone) was granted marketing authorization for commercial use in the EU for the treatment of adults with mild to moderate IPF and we subsequently launched commercial sales of Esbriet in Germany in September 2011 and in Austria, Denmark, Norway and Luxembourg in the first half of 2012; however, pirfenidone is still under investigation for the treatment of IPF in the United States and has not been approved by the FDA. Subject to EU country reimbursement timelines, we currently plan to conclude pricing and reimbursement discussions for Esbriet in France, Spain and Italy during the fourth quarter of 2012 and launch in those countries as soon as practicable after concluding discussions. We currently plan to conclude the discussions with the authorities in the United Kingdom in the first quarter of 2013, and, depending on the outcome of such discussions, make Esbriet available in the United Kingdom as soon as practicable thereafter if appropriate. In addition to launches in the remaining so called “Top 5” EU countries, we expect to launch Esbriet in Belgium, the Netherlands, Finland and Sweden in the second half of 2012 and in Ireland in the first quarter of 2013. Because we do not currently have a product candidate other than pirfenidone in clinical development, our future success is dependent on building a commercial operation in Europe to successfully commercialize Esbriet in the EU, obtaining regulatory approval from the FDA to market pirfenidone for the treatment of IPF in the United States, and, if approved by the FDA, successfully commercializing pirfenidone in the United States.

If we do not successfully commercialize Esbriet in the EU and/or receive regulatory approval in the United States for pirfenidone for the treatment of IPF, our ability to generate additional revenue will be jeopardized and, consequently, our business will be seriously harmed. We may not succeed in our commercial efforts in the EU, or, if approved by the FDA, in the United States, or we may never receive regulatory approval in the United States for pirfenidone, any of these will have a material adverse effect on our business and prospects. In the near term, we may experience delays and unforeseen difficulties in the launch of Esbriet in one or more of the European Member states, including as a result of obtaining unfavorable pricing and/or reimbursement, which could negatively affect our stock price. We may also experience delays in obtaining regulatory approval in the United States for pirfenidone, if it is approved at all and our stock price may be negatively affected.

In addition, we anticipate incurring additional expenses and utilizing significant existing cash resources as we continue our commercialization efforts in Germany, Austria, Denmark, Norway and Luxembourg, continue our preparations for the commercial launch of Esbriet in other countries in Europe, conduct our Phase 3 ASCEND trial to support the approval of pirfenidone to treat IPF in the United States and continue to grow our operational capabilities, particularly in the EU. This represents a significant investment in the regulatory and commercial success of pirfenidone, which is uncertain.

We may also fail to develop future product candidates for the reasons stated in “Risks Related to the Development of Our Products and Product Candidates.” If this were to occur, we will continue to be dependent on the successful commercialization of pirfenidone, our development costs may increase and our ability to generate revenue could be impaired.

We have initiated the ASCEND Phase 3 clinical trial to support potential FDA approval of pirfenidone for the treatment of IPF, the results of which may fail to demonstrate to the FDA sufficient efficacy of pirfenidone and may have a negative effect on sales of Esbriet in the European Union.

We have evaluated our clinical development options to gain FDA approval of pirfenidone for the treatment of IPF within the United States and initiated an additional Phase 3 clinical trial known as the “ASCEND” trial during the second quarter of 2011. We do not have a Special Protocol Assessment, or SPA, in place with the FDA for the ASCEND trial, and the results of this Phase 3 clinical trial, together with the results of our CAPACITY trials, may not be satisfactory to the FDA to support approval of pirfenidone. The ASCEND trial is a 52 week trial with a forced vital capacity, or FVC, primary endpoint. In our meeting with the FDA in March 2011 relating to our plans for the ASCEND trial, the FDA indicated that it would prefer a trial with a longer duration (72 weeks) if designed with a FVC endpoint. While the FDA indicated that a 52 week trial with a FVC endpoint could support approval, the FDA further indicated that a trial with a FVC endpoint would need to provide supportive evidence of an effect on mortality. Consistent with our prior interactions with the FDA in connection with our CAPACITY clinical trials, the FDA indicated a preference for a mortality endpoint.

Whether data from our ASCEND trial when combined with the data from our CAPACITY trials will be sufficient to obtain FDA approval of pirfenidone for the treatment of IPF will depend on the results from the trial and be the subject of review by the FDA at the time of our anticipated NDA resubmission. If the results of the ASCEND trial are not satisfactory to the FDA to support regulatory approval of pirfenidone in the United States, then we will not be able to sell Esbriet in the United States, and sales of Esbriet in the EU may be negatively affected. Additionally, as in any clinical trial, discovery of unknown problems with pirfenidone in the ASCEND trial could negatively impact the approved safety and efficacy profile and result in possible reduced sales or product withdrawal in the EU. Because of our dependence on the commercial success of Esbriet in the EU, a negative outcome in the ASCEND trial or a negative regulatory outcome by the FDA could materially and adversely affect our business and prospects. For additional risks related to clinical studies and government regulations, see the risks under “Risks Related to Government Regulation and Approval of Our Products and Product Candidates.”

Risks Related to the Commercialization of Our Products and Product Candidates

Our revenue from sales of Esbriet in the European Union is dependent upon the pricing and reimbursement guidelines adopted in each of the various countries in the European Union, which levels may fall well below our current expectations.

We have currently priced Esbriet in Germany as well as Austria, Sweden, Norway, Denmark, Luxembourg and Iceland and have developed estimates of anticipated pricing in other countries in Europe. These estimates are our expectations, which are based upon the lethal nature of IPF, the lack of any approved therapies for IPF, the Orphan Drug designation of Esbriet, our perception of the overall cost benefit of Esbriet and the current pricing in the EU of therapies with a similar product profile, such as treatments for pulmonary hypertension. However, due to efforts to provide for containment of health care costs, one or more EU countries may not support our estimated level of governmental pricing and reimbursement for Esbriet, particularly in light of the budget crises faced by a number of countries in the EU, which would negatively impact anticipated revenue from Esbriet in the EU. For example, in December 2011, the Institute for Quality and Efficiency in Health Care (the “IQWiG”), a non-profit private foundation established in Germany to provide advisory evaluations of the benefits and costs of medical interventions to Germany’s Federal Joint Committee (the “G-BA”), published its report on the benefit assessment of Esbriet concluding that there is no additional benefit of pirfenidone for the treatment of mild to moderate IPF. We subsequently submitted a detailed response to the IQWiG concerning the assumptions and methodology applied by the IQWiG in its assessment, and, in March 2012, the G-BA concluded that Esbriet does provide additional benefit (not quantifiable) for the treatment of mild to moderate IPF. On July 23, 2012, we announced the early conclusion of negotiations for the reimbursement price of Esbriet^® (pirfenidone) in Germany such that effective September 15, 2012 and until September 15, 2014, the net ex-factory Esbriet price in Germany will be 26,999 €, or approximately $33,000 per patient per year, representing an approximate 10% discount from the current price. Such pricing is subject to the rules of the German Act on the Reform of the Market for Medicinal Products which provide that terms for an orphan drug must be re-evaluated following the drug’s costs to the German health system of 50 million Euros in any 12-month period. Therefore, upon the earlier of such re-evaluation or September 15, 2014, the G-BA may lower its reimbursement guidelines with respect to Esbriet necessitating that we lower our pricing of Esbriet, which would also negatively impact anticipated revenue from Esbriet in Germany.

In addition, in April 2012, the Transparency Commission of the French National Health Authority, the French agency responsible for assessing medicinal products and advising the health authorities on whether those products provide sufficient benefit to be covered by French National Health Insurance, issued a favorable opinion for the reimbursement of Esbriet^® by French National Health

Insurance. The Transparency Commission noted that no other treatment provided evidence of a clinical benefit in IPF and considering all available information, Esbriet was granted an Amélioration du Service Medical Rendu (ASMR) rating of level IV. ASMR is a rating of added clinical value in comparison with existing therapies. The Transparency Commission focused on the risk/benefit ratio for assessing the actual medical benefit, and rated it as “Low.” An unfavorable outcome following the pricing review period in Germany or in other EU countries may result in lower than expected pricing and reimbursement guidelines in Germany or other countries in the EU, which would adversely impact the anticipated revenue from Esbriet in the EU.

Finally, while we were awarded reimbursement in Sweden, it was limited to the sub-population of patients with a predicted FVC lower than 80%. While we deem these restrictions in Sweden as limiting only modestly the overall business potential of Esbriet in Europe and worthwhile considering the favorable price achieved, they may result in the pursuit by other European countries of a similar approach and a higher loss of Esbriet volume than anticipated, which would negatively impact revenue from Esbriet in such countries.

Expansion of our commercial infrastructure in the European Union is a significant undertaking that requires substantial financial and managerial resources, and we may not be successful in our efforts. We may also continue to encounter unexpected or unforeseen delays in establishing a commercial infrastructure in the European Union, which may negatively impact our timing of and ability to launch our commercial efforts for Esbriet.

In March 2011, the European Commission granted marketing authorization for Esbriet (pirfenidone) in adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. We launched commercial sales of Esbriet in Germany in September 2011 and in Austria, Denmark, Norway and Luxembourg in the first half of 2012. Subject to EU country reimbursement timelines, we currently plan to conclude pricing and reimbursement discussions for Esbriet in France, Spain and Italy during the fourth quarter of 2012 and launch in those countries as soon as possible after concluding discussions. We currently plan to conclude the discussions with the authorities in the United Kingdom in the first quarter of 2013, and, depending on the outcome of such discussions, make Esbriet available in the United Kingdom as soon as practicable thereafter if appropriate. In addition to launches in the remaining so called “Top 5” EU countries, we expect to launch Esbriet in Belgium, the Netherlands, Finland and Sweden in the second half of 2012 and in Ireland in the first quarter of 2013. A commercial launch of this size is a significant undertaking that requires substantial financial and managerial resources. To support our anticipated marketing efforts in Europe, we are currently working to expand our commercial infrastructure within the EU, including an increase to our employee headcount in that region and the establishment of our European headquarters in Muttenz, Switzerland. Further, in December 2010, we transferred all of our non-U.S. rights to research, develop and commercialize pirfenidone for IPF to our wholly-owned Swiss subsidiary, InterMune International AG. However, in order to successfully launch our commercial operations, we will need to increase the number of our managerial, operational, financial and other employees in the EU, which will require additional financial resources and require significant management attention. We may not be successful in establishing a commercial operation in the EU (including, but not limited to, failing to attract, retain and motivate the necessary skilled personnel and failing to develop a successful marketing strategy), the effect of which will have a negative outcome on our ability to commercialize Esbriet and generate revenue from the sale of Esbriet.

Additionally, we may encounter further unexpected or unforeseen delays in establishing our commercial operations that delay the launch of our commercial operations in one or more EU member states. These further delays may further increase the cost of and the resources required for successful commercialization of Esbriet in the EU. Given our limited commercial history, we do not have significant experience in a commercial launch of this size.

Even if regulatory authorities approve our products or product candidates for the treatment of the diseases that we are targeting, our products may not be marketed or commercially successful.

The development of our products and product candidates is an expensive process, and we anticipate that the annual cost of treatment for the diseases for which we are seeking approval will be significant. These costs will vary for different diseases based on the dosage and method of administration. Accordingly, we may decide not to market any of our products or product candidates for an approved disease because we believe that it may not be commercially successful. Market acceptance of and demand for our products and product candidates, including Esbriet in the EU, will depend on many factors, including, but not limited to:

•

cost of treatment;

•

pricing and availability of alternative products;

•

our ability to obtain third-party coverage or reimbursement for our products or product candidates to treat a particular disease;

•

perceived efficacy relative to other available therapies;

•

shifts in the medical community to new treatment paradigms or standards of care;

•

relative convenience and ease of administration; and

•

prevalence and severity of adverse side effects associated with treatment.

In addition, we still are only in the early stages of our commercial sales of Esbriet in Germany and have only just begun our commercial sales in Austria, Denmark, Norway and Luxembourg and continue to have limited information with regard to the market acceptance of Esbriet. As a result, we may have to revise our estimates regarding the acceptance of Esbriet under our current pricing structure, reevaluate and/or change the current pricing for Esbriet. For more information, please see the risk factor above titled “Our revenue from sales of Esbriet in the European Union is dependent upon the pricing and reimbursement guidelines adopted in each of the various countries in the European Union, which levels may fall well below our current expectations.”

The pricing and profitability of our products may be subject to control by the government and other third-party payors, and if third-party payors do not provide coverage or reimburse patients for Esbriet or our other current or future products, our revenue and prospects for profitability will suffer.

The pricing and profitability of our products may be subject to control by the government and other third-party payors. In many foreign markets, the pricing and/or profitability of prescription pharmaceuticals are subject to governmental control. In the United States, we expect that there will continue to be federal and state proposals to implement similar governmental controls, such as the omnibus healthcare reform legislation recently adopted by the U.S. government. As a result, our ability to successfully commercialize Esbriet or other product candidates for particular diseases, is highly dependent on the extent to which coverage and reimbursement for such products is available from:

•

private health insurers, including managed care organizations;

•

governmental payors, such as state-run payors in the EU, as well as federal programs/payors such as Medicaid, the U.S. Public Health Service Agency and Veterans’ Administration; and

•

other third-party payors.

The continuing efforts of governmental and other third-party payors to contain or reduce the cost of healthcare through various means may adversely affect our ability to successfully commercialize our products. If governmental and other third-party payors do not provide adequate coverage and reimbursement levels for Esbriet, or our other current or future products, market acceptance of our products will be reduced, and our sales will suffer. For example, on July 23, 2012, we announced the early conclusion of negotiations for the reimbursement price of Esbriet^® (pirfenidone) in Germany such that effective September 15, 2012 and until September 15, 2014, the net ex-factory Esbriet price in Germany will be 26,999 €, or approximately $33,000 per patient per year, representing an approximate 10% discount from the current price. Such pricing is subject to the rules of the German Act on the Reform of the Market for Medicinal Products which provide that terms for an orphan drug must be re-evaluated following the drug’s costs to the German health system of 50 million Euros in any 12-month period. Therefore, upon the earlier of such re-evaluation or September 15, 2014, the G-BA may lower its reimbursement guidelines with respect to Esbriet necessitating that we lower our pricing of Esbriet, , which would also negatively impact revenue from Esbriet in Germany. Although we cannot predict the full effects on our business of the implementation of the healthcare reform bill in the United States, it is possible that this legislation or other similar legislation will result in decreased reimbursement for prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices charged for prescription drugs. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. These new and any future cost-control initiatives could decrease the price that we would receive for Esbriet, if approved for use in the United States, or any other products that we may develop in the future, which would reduce our revenue and potential profitability.

If we are found to have breached our agreement with Shionogi or if it is otherwise determined that we are obligated to make royalty payments on sales of Esbriet in the European Union to Shionogi, our expenses associated with sales of Esbriet in the European Union will increase and our ability to generate net income from Esbriet sales will be adversely affected.

On July 5, 2012, Shionogi filed a complaint against us in the United States District Court for the Northern District of California. Shionogi’s complaint alleges principally that we breached our May 2004 agreement with Shionogi (as amended) governing the exchange and use of certain documents and information relating to the parties’ respective clinical trials of pirfenidone. The complaint alleges that we breached the agreement by utilizing certain of Shionogi’s information in our MAA and other submissions for pirfenidone with the EMA and then failing to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. In the alternative, the complaint alleges that, if

we did not use Shionogi’s information in a way that would trigger a royalty obligation under the agreement, we had an obligation to do so as an exclusive licensee. Shionogi is seeking, among other things, unspecified monetary damages and a declaration that we are obligated to pay royalties to Shionogi for all sales of pirfenidone (Esbriet^®) in the European Union. While we disagree that we owe any such royalties and intend to defend our position vigorously, an unfavorable outcome in the litigation or in any negotiations with Shionogi could require that we pay royalties or make other payments to Shionogi, which would increase our expenses associated with sales of Esbriet in the EU and adversely affect our ability to generate net income.

The activities of competitive drug companies, or others, may limit our products’ revenue potential or render them obsolete.

Our commercial opportunities will be reduced or eliminated if our competitors develop or market products that, compared to our products or product candidates:

•

are more effective;

•

have fewer or less severe adverse side effects;

•

are better tolerated;

•

have better patient compliance;

•

receive better reimbursement terms;

•

are more accepted by physicians;

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are more adaptable to various modes of dosing;

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have better distribution channels;

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are easier to administer; or

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are less expensive, including but not limited to a generic version of pirfenidone.

Even if we are successful in developing effective drugs, our products may not compete effectively with our competitors’ current or future products. We expect that Esbriet may compete in the EU and, if approved by the FDA in the U.S., may compete with other products that are being developed for the treatment of IPF, including possible generic versions of pirfenidone in the U.S., EU and potentially other markets following the expiration of, or in the absence of market exclusivity. Pirfenidone has no composition of matter patent protection. Unless we have (i) Orphan Drug designation, (ii) data exclusivity protection or (iii) other types of patent protection in a particular jurisdiction, we may face competition from a lower cost generic version of pirfenidone in such a jurisdiction. In addition, there are many pharmaceutical companies, biotechnology companies, public and private universities, government agencies and research organizations actively engaged in research and development of products, some of which may target the same indications as our product candidates. For example, in December 2010, Gilead entered into an agreement to acquire Arresto gaining Gilead access to Arresto’s Phase 1 humanized monoclonal antibody compound, AB0024, currently in clinical development for the treatment of IPF. Additionally, Boehringer Ingelheim, or BI, has recently presented phase 2 data for BIBF-1120, a triple kinase inhibitor that has showed some potential efficacy at high doses in IPF. BI has publicly posted its Phase 3 trial design for BIBF-1120 in IPF and patient enrollment is ongoing. Furthermore, there are seven products in various stages of phase 2 development for IPF, including CC-4047 and CC-930 from Celgene, CNTO-888 from Janssen (J&J), FG-3019 from Fibrogen, GC-1008 from Sanofi, QAX-576 from Novartis and STX-100 from Biogen Idec (acquirer of Stromedix)). Finally, the PANTHER trial, sponsored by the National Institutes of Health and evaluating NAC (N-acetylcysteine) (a generic drug) versus placebo, is underway and completing its enrollment. If the results of such trial is positive, NAC, especially given that it is a generic drug, may create strong competition, especially in Europe, and create pressure on volume and prices of our Esbriet franchise. Our competitors include larger, more established, fully integrated pharmaceutical companies and biotechnology companies that have substantially greater capital resources, existing competitive products, larger research and development staffs and facilities, greater experience in drug development and in obtaining regulatory approvals and greater marketing capabilities than we do.

Risks Related to the Development of Our Products and Product Candidates

Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials.

To gain approval to market a product for the treatment of a specific disease, we must provide the FDA and foreign regulatory authorities with clinical data that adequately demonstrate the safety and efficacy of that product for the intended indication applied for

in the NDA or respective regulatory file. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in clinical trials, even after promising results in earlier preclinical or clinical trials. These setbacks have been caused by, among other things, preclinical findings made while clinical studies were underway and safety or efficacy observations made in clinical studies. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and the results of clinical trials by other parties may not be indicative of the results in trials we may conduct. For example, in March 2007, we terminated our development of Actimmune for patients with IPF as a result of our decision to discontinue the INSPIRE trial on the recommendation of the study’s independent DMC. For specific risks related to the pirfenidone development program, please see the risk factor titled “If our clinical trials fail to demonstrate to the FDA and foreign regulatory authorities that any of our products or product candidates are safe and effective for the treatment of particular diseases, the FDA and foreign regulatory authorities may require us to conduct additional clinical trials or may not grant us marketing approval for such products or product candidates for those diseases” below.

We do not know whether future clinical trials will be initiated, or will be completed on schedule, or at all.

The commencement or completion of any of our clinical trials may be delayed, halted, or discontinued for numerous reasons, including, but not limited to, the following:

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patients do not enroll in clinical trials at the rate we expect;

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the FDA or other regulatory authorities do not approve a clinical trial protocol or place a clinical trial on clinical hold;

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we may not be able to identify or develop a product candidate that can be successful for clinical development;

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patients experience adverse side effects or unsafe toxicity levels;

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patients withdraw or die during a clinical trial for a variety of reasons, including adverse events associated with the advanced stage of their disease and medical problems that may or may not be related to our products or product candidates;

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the interim results of the clinical trial are inconclusive or negative;

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our trial design, although approved, is inadequate to demonstrate safety and/or efficacy;

•

third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;

•

our contract laboratories fail to follow good laboratory practices; or

•

sufficient quantities of the trial drug are not available.

In particular, we have experienced a delay and may continue to experience further delays in the completion of our enrollment in our ASCEND clinical trial resulting from lower than anticipated patient enrollment. Our development costs will further increase if we have further material delays in our current clinical trials for pirfenidone or if we need to perform more or larger clinical trials than as may be initially planned for future product candidates. If there are any significant delays for any of our other current or planned clinical trials, our business, financial condition, financial results and the commercial prospects for our products and product candidates will be harmed, and our prospects for profitability will be impaired.

In addition, delays or discontinuations of our clinical trials could require us to cease development efforts of a product candidate in part or altogether, which will harm our business or financial condition and the commercial prospects for such product and product candidate.

Risks Related to Government Regulation and Approval of our Products and Product Candidates

If our clinical trials fail to demonstrate to the FDA and foreign regulatory authorities that any of our products or product candidates are safe and effective for the treatment of particular diseases, the FDA and foreign regulatory authorities may require us to conduct additional clinical trials or may not grant us marketing approval for such products or product candidates for those diseases.

We are not permitted to market our product candidates in the United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries. Before obtaining regulatory approvals for the

commercial sale of any product candidate for a target indication, we must demonstrate with evidence gathered in preclinical and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA and, with respect to approval in other countries, similar regulatory authorities in those countries, that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate. Our failure to adequately demonstrate the safety and effectiveness of any of our products or product candidates for the treatment of particular diseases may delay or prevent our receipt of the FDA’s and foreign regulatory authorities’ approval and, ultimately, may prevent commercialization of our products and product candidates for those diseases. The FDA and foreign regulatory authorities have substantial discretion in deciding whether, based on the benefits and risks in a particular disease, any of our products or product candidates should be granted approval for the treatment of that particular disease. Even if we believe that a clinical trial or trials has demonstrated the safety and statistically significant efficacy of any of our products or product candidates for the treatment of a disease, the results may not be satisfactory to the FDA or foreign regulatory authorities. Preclinical and clinical data can be interpreted by the FDA and foreign regulatory authorities, including their advisory committees, in different ways, which could delay, limit or prevent regulatory approval. In addition, even if advisory committees to the FDA recommend approval of our product candidates, such recommendations are non-binding and the FDA may not approve our NDA for the product candidates. For example, nine of the twelve members of the Pulmonary-Allergy Drugs Advisory Committee, or PADAC, of the FDA recommended approval of pirfenidone to reduce decline in lung function in patients with IPF. However, notwithstanding the PADAC approval recommendation, we subsequently received a Complete Response Letter from the FDA requesting an additional clinical trial to support the efficacy of pirfenidone. If regulatory delays are significant or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our products or product candidates involved will be harmed, and our prospects for profitability will be significantly impaired.

Our CAPACITY trials were conducted without a SPA with the FDA. The FDA’s SPA process creates a written agreement between the sponsoring company and the FDA regarding clinical study design and other clinical study issues that can be used to support approval of a product candidate. We did not obtain a SPA agreement with the FDA and therefore there was no assurance that the results would provide a sufficient basis in the view of the FDA for the FDA to grant regulatory approval of a new drug application for pirfenidone for the treatment of IPF. In addition, while the FDA will consider and approve NDAs based on various endpoints, the FDA had indicated that mortality is the ideal endpoint for IPF clinical trials. We designed and conducted CAPACITY 1 and CAPACITY 2 based on FVC change as the primary endpoint, as opposed to mortality. The FDA had advised us that they were uncertain as to what would constitute a clinically meaningful treatment effect of pirfenidone on this endpoint and reviewed the effect of pirfenidone not only based on FVC change but also based on the totality of the data, including the effect of pirfenidone on all of the specified efficacy endpoints as well as the safety data to help determine the risk-benefit profile of pirfenidone in IPF patients. The primary endpoint of FVC change was met with statistical significance in CAPACITY 2 but not in CAPACITY 1. Therefore, we did not replicate the efficacy of pirfenidone for the treatment of IPF in a second pivotal study. Moreover, because the data base for the Shionogi Phase 3 study was not included in our NDA, the FDA did not consider this study to support the efficacy of pirfenidone. Rather the adequacy of our application to support the efficacy of pirfenidone for the treatment of IPF was determined by the FDA during the review of our NDA. While in our view the totality of the data from CAPACITY 1 and CAPACITY 2 support the efficacy and safety of pirfenidone in IPF, the FDA disagreed with our view and decided that such data does not adequately support approval of our NDA filing and issued to us a Complete Response Letter on May 4, 2010 requesting an additional clinical trial to support the efficacy of pirfenidone in IPF. We began a new Phase 3 clinical study, the ASCEND trial, during the second quarter of 2011. We did not obtain a SPA agreement with the FDA with respect to the ASCEND trial. The results of this Phase 3 clinical trial may not be satisfactory to the FDA to receive regulatory approval. For additional information related to the risk of the new Phase 3 clinical study, please see the risk factor under the caption “Risks Related to Our Dependence on Pirfenidone—We have initiated the ASCEND Phase 3 clinical trial to support potential FDA approval of pirfenidone for the treatment of IPF, the results of which may fail to demonstrate to the FDA sufficient efficacy of pirfenidone and may have a negative effect on sales of Esbriet in the European Union.”

We are subject to extensive and rigorous governmental regulation, including the requirement of FDA or other regulatory approval before our products and product candidates may be lawfully marketed.

Both before and after the approval or our product candidates and product, we, our product candidates, our product, our operations, our facilities, our suppliers, and our contract manufacturers, contract research organizations, and contract testing laboratories are subject to extensive regulation by governmental authorities in the United States and other countries, with regulations differing from country to country. In the United States, the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products. Failure to comply with applicable requirements could result in, among other things, one or more of the following actions: notices of violation, untitled letters, warning letters, fines and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product candidate; product recall or seizure; interruption of manufacturing or clinical trials; operating restrictions; injunctions; and criminal prosecution. We or the FDA, or an institutional review board, may suspend or terminate human clinical trials at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk. Any failure to receive the marketing approvals necessary to commercialize our product candidates could harm our business.

The regulatory review and approval process of governmental authorities is lengthy, expensive and uncertain, and regulatory standards may change during the development of a particular product candidate. We are not permitted to market our product candidates in the United States or other countries until we have received requisite regulatory approvals. The FDA review process typically takes significant time to complete and approval is never guaranteed. If a product is approved, the FDA may limit the indications for which the product may be marketed, require extensive warnings on the product labeling, impose restricted distribution programs, require expedited reporting of certain adverse events, or require costly ongoing requirements for post-marketing clinical studies and surveillance or other risk management measures to monitor the safety or efficacy of the product. Markets outside of the United States such as the EU also have requirements for approval of drug candidates with which we must comply prior to marketing. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure we will be able to obtain regulatory approval in other countries, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. Also, any regulatory approval of any of our products or product candidates, once obtained, may be withdrawn.

The FDA has increased its attention to product safety concerns in light of recent high profile safety issues with certain drug products, in the United States. Moreover, heightened Congressional scrutiny on the adequacy of the FDA’s drug approval process and the agency’s efforts to assure the safety of marketed drugs has resulted in proposed agency initiatives and new legislation addressing drug safety issues. If adopted, any new legislation or agency initiatives could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance with any new post-approval regulatory requirements. These restrictions or requirements could require us to conduct costly studies.

In addition, we, our suppliers, our operations, our facilities, our contract manufacturers, our contract research organizations, and our contract testing laboratories are required to comply with extensive FDA requirements both before and after approval of our products. For example, we are required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with certain requirements concerning advertising and promotion for our product candidates and our products. Also, quality control and manufacturing procedures must continue to conform to current Good Manufacturing Practices, or cGMP, regulations after approval, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control. In addition, discovery of safety issues may result in changes in labeling or restrictions on a product manufacturer or NDA holder, including removal of the product from the market.

Our failure or alleged failure to comply with federal, state and foreign laws governing anti-kickback, false claims and anti-corruption could result in civil and/or criminal sanctions and/or harm our business.

If we market a future product in the United States, we will be subject to various federal and state laws pertaining to health care “fraud and abuse” including anti-kickback laws and false claims laws. Subject to certain exceptions, the anti-kickback laws make it illegal for a prescription drug manufacturer to knowingly and willfully solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. The federal government has published regulations that identify “safe harbors” or exemptions for certain payment arrangements that do not violate the anti-kickback statutes. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of our practices, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly presenting, or causing to be presented, for payment to third party payors (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed or claims for medically unnecessary items or services. Our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of Medicaid rebate information and other information affecting federal and state and third-party payment for our products, and the sale and marketing of our products, could become subject to scrutiny under these laws. In addition, pharmaceutical companies have been prosecuted under the False Claims Act in connection with their “off-label” promotion of drugs.

We are subject to similar laws in foreign countries where we conduct business. For example, within the EU, the control of unlawful marketing activities is a matter of national law in each of the member states. The member states of the EU closely monitor perceived unlawful marketing activity by companies. We could face civil, criminal and administrative sanctions if any member state determines that we have breached our obligations under its national laws. Industry associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition could be adversely affected.

We are also subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws in foreign countries, such

as the U.K. Bribery Act of 2010, which became effective on July 1, 2011. In general, there is a worldwide trend to strengthen anticorruption laws and their enforcement. Any violation of these laws by us or our agents or distributors could create a substantial liability for us, subject our officers and directors to personal liability and also cause a loss of reputation in the market. Becoming familiar with and implementing the infrastructure necessary to comply with laws, rules and regulations applicable to new business activities and mitigate and protect against corruption risks could be quite costly. In addition, failure by us or our agents or distributors to comply with these laws, rules and regulations could delay our expansion and could adversely affect our business.

If we are alleged to have violated, or are convicted of violating, these laws, there could be a material adverse effect on us, including a substantial fine, decline in our stock price, or both. Our activities could be subject to challenge for the reasons discussed above and due to the broad scope of these laws and the increasing attention being given to them by law enforcement authorities.

Risks Related to Manufacturing and Our Dependence on Third Parties

The manufacturing and manufacturing development of our products and product candidates present technological, logistical and regulatory risks, each of which may adversely affect our potential revenue.

The manufacturing and manufacturing development of pharmaceuticals are technologically and logistically complex and heavily regulated by the FDA and other governmental authorities. The manufacturing and manufacturing development of our products and product candidates present many risks, including, but not limited to, the following:

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It may not be technically feasible to scale up an existing manufacturing process to meet demand or such scale-up may take longer than anticipated; and

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Failure to comply with strictly enforced good manufacturing practices regulations and similar foreign standards may result in delays in product approval or withdrawal of an approved product from the market. For example, the FDA has conducted routine inspections of our manufacturing contractors, and some were issued a standard “notice of observations.” Failure to correct any deficiency could result in manufacturing delays.

Any of these factors could delay clinical trials, regulatory submissions and/or commercialization of our products for particular diseases, interfere with current sales, entail higher costs and result in our being unable to effectively sell our product and, in the future, our product candidates.

Our manufacturing strategy, which relies on third-party manufacturers, exposes us to additional risks as a result of which we may lose potential revenue.

We do not have the resources, facilities or experience to manufacture our product or any of our product candidates ourselves. Completion of our clinical trials and commercialization of our products requires access to, or development of, manufacturing facilities that meet FDA standards to manufacture a sufficient supply of our products. The FDA, the EU and foreign regulatory authorities must approve facilities that manufacture our products for commercial purposes, as well as the manufacturing processes and specifications for the product. We depend on third parties for the manufacture of our product candidates for preclinical and clinical purposes, and we rely on third parties with FDA-approved manufacturing facilities for the manufacture of Esbriet for commercial purposes. We have a long-term supply contract Signa C.V. and ACIC Fine Chemicals Inc. for Esbriet active pharmaceutical ingredient and a contract with Catalent for the manufacture of the drug product for Esbriet. However, if we do not perform our obligations under these agreements, these agreements may be terminated.

Our manufacturing strategy for our products and product candidates presents many risks, including, but not limited to, the following:

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If market demand for our products is less than our purchase obligations to our manufacturers, we may incur substantial penalties and substantial inventory write-offs.

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Manufacturers of our product and our product candidates are subject to ongoing periodic inspections by the EU, FDA and other regulatory authorities for compliance with strictly enforced good manufacturing practices regulations and similar foreign standards, and we do not have control over our third-party manufacturers’ compliance with these regulations and standards.

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When we need to change third party manufacturers of a particular pharmaceutical product, the EU, FDA and foreign regulatory authorities must approve the new manufacturers’ facilities and processes prior to our use or sale of products it manufactures for us. This requires demonstrated compatibility of product, process and testing and compliance inspections. Delays in transferring manufacturing technology between third parties could delay clinical trials, regulatory submissions and commercialization of our product candidates.

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Our manufacturers might not be able or may refuse to fulfill our commercial or clinical trial needs, which would require us to seek new manufacturing arrangements and may result in substantial delays in meeting market or clinical trial demands. For example, our current long-term supply contract with Signa C.V. and ACIC Fine Chemicals Inc. for the active pharmaceutical ingredient for Esbriet does not impose any obligation on Signa C.V. or ACIC Fine Chemicals Inc. to reserve a minimum annual capacity for the production of such ingredient, which could impair our ability to obtain product from them in a timely fashion.

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We may not have intellectual property rights, or may have to share intellectual property rights, to any improvements in the manufacturing processes or new manufacturing processes for our products.

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Our product costs may increase if our manufacturers pass their increasing costs of manufacture on to us.

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If third-party manufacturers do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain or maintain regulatory approvals for our products and product candidates and we may experience stock-outs. This would adversely impact our ability to successfully commercialize our products and product candidates. Furthermore, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers in a timely manner, if at all.

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If our agreement with a third-party manufacturer expires, we may not be able to renegotiate a new agreement with that manufacturer on favorable terms, if at all. If we cannot successfully complete such renegotiation, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers in a timely manner, if at all.

Any of these factors could delay clinical trials, regulatory submissions or commercialization of our products for particular diseases, interfere with current sales, entail higher costs and result in our being unable to effectively sell our products.

A disruption in our ability to ship Esbriet from our packaging facilities to our distributor in the European Union or a disruption in our distribution channels in the European Union could result in significant product delays and adversely affect our results.

We currently ship Esbriet from packaging facilities to our distributor in the EU. A disruption in our ability to ship Esbriet to our distributor in the EU or a disruption in our distribution channels in the EU for any reason, including as a result of a natural disaster, terrorism or failure of our commercial carrier, could result in product delivery delays. If this were to occur, we may be unable to satisfy customer orders on a timely basis, if at all. A significant disruptive event to our ability to distribute Esbriet could adversely affect our ability to generate revenue from Esbriet and materially affect our business and results of operations.

We rely on third parties to conduct clinical trials for our product and product candidates, and those third parties may not perform satisfactorily.

If our third-party contractors do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed in or prevented from obtaining regulatory approvals for our products and product candidates, and may not be able to successfully commercialize our products and product candidates for targeted diseases. We do not have the ability to independently conduct clinical trials for all of our products and product candidates, and we rely on third parties such as contract research organizations, medical institutions and clinical investigators to perform this function. For example, we use contract research organizations to conduct our new Phase 3 ASCEND trial for pirfenidone. Our ability to monitor and audit the performance of these third parties is limited. If these third parties do not perform satisfactorily, our clinical trials may be extended or delayed, resulting in potentially substantial cost increases to us and other adverse impacts on our product development efforts. We may not be able to locate any necessary acceptable replacements or enter into favorable agreements with them, if at all.

Risks Related to Our Intellectual Property Rights

We may not be able to obtain, maintain and protect certain proprietary rights necessary for the development and commercialization of our products or product candidates.

Our commercial success will depend in part on obtaining and maintaining patent protection on our products and product candidates and successfully defending these patents against third-party challenges. Our ability to commercialize our products will also depend in part on the patent positions of third parties, including those of our competitors. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the

breadth of claims allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict with certainty the scope and breadth of patent claims that may be afforded to other companies’ patents. In addition, each country has its own rules regarding the allowability and enforceability of certain types of patents and therefore there can be no assurance that our patents applications will be granted or that our issued patents will be enforceable in any given jurisdiction. We could incur substantial costs in litigation if we are required to defend against patent suits brought by third parties, or if we initiate suits to protect our patent rights.

Any litigation, including any interference proceedings to determine priority of inventions, oppositions to patents in foreign countries or litigation against our partners may be costly and time consuming and could harm our business. Litigation may be necessary in some instances to determine the validity, enforceability, scope and infringement of certain of our proprietary rights. Litigation may be necessary in other instances to determine the validity, scope or non-infringement of patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rights or hinder our ability to manufacture and market our products.

The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:

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we were the first to make the inventions covered by each of our pending patent applications;

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we were the first to file patent applications for these inventions;

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others will not independently develop similar or alternative technologies or duplicate any of our technologies;

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any of our pending patent applications will result in issued patents;

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any of our issued patents or those of our licensors will be valid and enforceable;

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any patents issued to us or our collaborators will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties;

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we will develop additional proprietary technologies that are patentable; or

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the patents of others will not have a material adverse effect on our business.

For example, the pirfenidone molecule itself has no composition of matter patent protection in the United States or elsewhere. We must therefore rely primarily on the protection afforded by formulation and method of use patents relating to the use of pirfenidone for the treatment in adults of mild to moderate IPF. While many countries such as the United States permit method of use patents relating to the use of drug products, in some countries the law relating to patentability of such use claims is evolving and may be unfavorably interpreted to prevent us from patenting some or all of our pending patent applications. There are some countries that currently do not allow such method of use patents, or that significantly limit the types of uses that are patentable.

In the EU, patents are subject to a post-grant opposition period, and enforcement of patents is on a country-by-country basis subject to varying, complex and evolving national requirements and standards. Competitors could challenge the validity of our patent claims and challenge whether their product actually infringes those claims. Such challenges would involve complex legal and factual questions and entail considerable costs and investment of effort.

Others have filed and in the future may file patent applications covering uses and formulations of pirfenidone, or interferon gamma-1b, or other products in our development program. If a third party has been or is in the future issued a patent that blocked our ability to commercialize any of our products, alone or in combination, for any or all of the diseases that we are targeting, we would be prevented from commercializing that product or combination of products for that disease or diseases unless we obtained a license from the patent holder. We may not be able to obtain such a license to a blocking patent on commercially reasonable terms, if at all. If we cannot obtain, maintain and protect the necessary proprietary rights for the development and commercialization of our products or product candidates, our business and financial prospects will be impaired.

The pirfenidone molecule itself has no composition of matter patent protection in the United States or elsewhere, and may only be protected for the treatment of IPF by orphan drug designation in the United States and European Union.

The pirfenidone molecule itself has no composition of matter patent protection in the United States or elsewhere. In the EU we have been granted orphan drug designation for pirfenidone for the treatment of IPF by the EMA, which provides for ten years of market exclusivity until March 2021. The exclusivity period afforded by orphan drug designation in the United States begins on first NDA approval for this product in IPF and ends seven years thereafter. Therefore, we may not have the ability to prevent others from commercializing pirfenidone for (i) IPF after the orphan drug designation exclusivity period ends, (ii) uses of pirfenidone covered by other patents held by third parties or (iii) other uses of pirfenidone in the public domain for which there is no patent protection. We are relying on exclusivity granted from orphan drug designation in IPF to protect pirfenidone from competitors in this indication and,

following expiration of orphan drug protection in the EU, and if approved for commercial use by the FDA, in the United States, we must rely primarily on the protection afforded by formulation and method of use patents relating to the safe and/or effective use of pirfenidone for IPF. We cannot provide any assurance that we will be able to maintain this orphan drug designation. Furthermore, although pirfenidone has received orphan drug marketing exclusivity for the treatment of patients with IPF, the FDA and/or the EMA can still approve different drugs for use in treating the same indication or disease, which would create a more competitive market for us and our revenues will be diminished.

In addition, other third parties have obtained patents in the United States and elsewhere relating to formulation and methods of use of pirfenidone for the treatment of certain diseases. As a result, it is possible that we could face competition from third party products that have pirfenidone as the active pharmaceutical ingredient. If a third party were to obtain FDA approval in the United States for the use of pirfenidone, or regulatory approval in another jurisdiction, for an indication before we did, such third party would be first to market and could establish the price for pirfenidone in these jurisdictions. This could adversely impact our ability to implement our pricing strategy for the product and may limit our ability to maximize the commercial potential of pirfenidone in the United States and elsewhere. The presence of a lower priced competitive product with the same active pharmaceutical ingredients as our product could lead to use of the competitive product for our anti-fibrotic indications. This could lead to pricing pressure for pirfenidone, which would adversely affect our ability to generate revenue from the sale of pirfenidone for anti-fibrotic indications.

Pirfenidone is the only commercially approved drug approved for the treatment of mild to moderate IPF. There are no other existing approved treatments. Therefore the incidence and prevalence of IPF that currently provide the basis of orphan drug designation in the European Union and the United States could change over time, and it is possible that orphan drug designation could be lost in these markets should the patient population exceed that required to maintain orphan drug status in these countries.

Market exclusivity afforded by orphan drug designation is generally offered as an incentive to drug developers to invest in developing and commercializing products for unique diseases that impact a limited number of patients. With respect to the United States, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. Qualification to maintain orphan drug status is generally monitored by the regulatory authorities during the orphan drug exclusivity period, currently seven years and ten years from the date of approval in the EU and United States, respectively. IPF is currently a poorly diagnosed disease in these markets. It is possible that with the approval of Esbriet in the EU, and the potential approval of pirfenidone in the United States, that the incidence and prevalence numbers for IPF could change in these markets. Should the incidence and prevalence of IPF patients who are eligible to receive pirfenidone for the treatment of IPF in these markets materially increase, it is possible that the orphan drug designation, and related market exclusivity, in these jurisdictions could be lost.

Following expiration of orphan drug designation in the European Union, and if approved for commercial use by the FDA, in the United States, our current intellectual property portfolio may not be sufficient to protect the continued exclusivity of pirfenidone for the treatment in adults of mild to moderate IPF.

Because the pirfenidone molecule itself has no composition of matter patent protection in the United States or elsewhere, following expiration of orphan drug designation in the EU, and if approved for commercial use by the FDA, in the United States, we must rely primarily on the protection afforded by the formulation and method of use patents relating to the safe and/or effective use of pirfenidone for the treatment in adults of mild to moderate IPF.

We have five granted patents and a number of pending patent applications in Europe relating to Esbriet’s formulation and use in IPF patients, particularly related to the safe and efficacious usage of the product. This collection of patents is expected to provide patent protection in Europe until 2030, and includes a granted patent that relates to the effect of food on the pharmacokinetics and safety of Esbriet, which expires in late 2026, a granted patent which relates to the safe and efficacious usage of Esbriet in patients who develop elevation in liver transaminase levels, which expires in late 2029, a granted patent relating to the titration of the dosing of Esbriet at the initiation of therapy, which expires in late 2027, a granted patent relating to the safe usage of Esbriet with respect to fluvoxamine that expires in 2030, and a granted patent relating to the safe usage of Esbriet with respect to smoking that expires in 2030. We also have nine issued patents in the United States relating to the formulation or safe and/or effective use of Esbriet in IPF patients, and a number of pending U.S. patent applications. In addition we have numerous pending patent applications under active prosecution in other foreign jurisdictions. The laws regarding patentability and enforceability of patents such as ours varies on a country by country basis.

These patents can be challenged by our competitors in various jurisdictions who may argue such patents are invalid or unenforceable, lack sufficient written description or enablement, or that the claims of the issued patents should be limited or narrowly construed. Additionally, even if the validity of these patents were upheld in a patent challenge, a court may refuse to stop the other

party from practicing the activity at issue on the ground that its activities are not covered by our patents. Any of these outcomes would limit our ability to exclusively market pirfenidone for the treatment in adults of mild to moderate IPF in the EU, and if approved for commercial use by the FDA, in the United States, as well as certain other countries where we have filed for patent protection.

If we breach our agreement with Shionogi, our ability to develop and commercialize pirfenidone in other jurisdictions may be impaired. In addition, Shionogi has demanded that it is entitled to royalty payments on our sales of Esbriet.

In February 2010, we entered into an agreement with Shionogi that gives us an option to exercise a license for access to certain patient level data from the Shionogi Phase 3 clinical trial with pirfenidone in patients with IPF, which we refer to as SP3, to be used, along with other Shionogi clinical study information, as “pivotal study data” (as defined in the agreement) in connection with our regulatory filings. We did not use SP3 patient level data as pivotal study data in our recently approved MAA or in any other submissions in connection with review of the MAA. Similarly, we did not use SP3 patient level data as pivotal study data in our U.S. NDA or in any other submissions in connection with review of the U.S. NDA. However, going forward, we may elect to use SP3 patient level data as pivotal study data in our regulatory filings in the United States or in other jurisdictions. Should we breach our agreement with Shionogi, we may lose our ability to use Shionogi’s patient level data in our regulatory filings in the United States or in other jurisdictions, which could adversely affect our ability to obtain regulatory approval of pirfenidone in such jurisdictions. In addition, in March 2012, following discussions with Shionogi, Shionogi demanded that we agree that it is entitled to royalty payments on our sales of Esbriet in Europe, based on Shionogi’s interpretation of our May 2004 agreement with Shionogi (as amended). On July 5, 2012, Shionogi filed a complaint against us in the United States District Court for the Northern District of California alleging, principally, that we breached that agreement by utilizing certain of Shionogi’s information in our MAA and other submissions for pirfenidone with the EMA and then failing to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. In the alternative, the complaint alleges that, if we did not use Shionogi’s information in a way that would trigger a royalty obligation under the agreement, we had an obligation to do so as an exclusive licensee. Shionogi is seeking, among other things, unspecified monetary damages and a declaration that we are obligated to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. While we disagree that we owe any such royalties and intend to defend our position vigorously, an unfavorable outcome in the litigation with Shionogi could require that we pay royalties or make other payments to Shionogi.

Litigation or third-party claims of intellectual property infringement could require us to spend substantial time and money and could adversely affect our ability to develop and commercialize products.

Our commercial success depends in part on our ability and the ability of our collaborators to avoid infringing patents and proprietary rights of third parties. Third parties may accuse us, or our collaborators, of employing their proprietary technology in our products, or in the materials or processes used to research or develop our products, without authorization. Any legal action against our collaborators or us claiming damages and/or seeking to stop our commercial activities relating to the affected products, materials and processes could, in addition to subjecting us to potential liability for damages, require our collaborators or us to obtain a license to continue to utilize the affected materials or processes or to manufacture or market the affected products. We cannot predict whether we, or our collaborators, would prevail in any of these actions or whether any license required under any of these patents would be made available on commercially reasonable terms, if at all. If we are unable to obtain such a license, we, or our collaborators, may be unable to continue to utilize the affected materials or processes or manufacture or market the affected products or we may be obligated by a court to pay substantial royalties and/or other damages to the patent holder. Even if we are able to obtain such a license, the terms of such a license could substantially reduce the commercial value of the affected product or products and impair our prospects for profitability. Accordingly, we cannot predict whether or to what extent the commercial value of the affected product or products or our prospects for profitability may be harmed as a result of any of the liabilities discussed above. Furthermore, infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate and can divert management’s attention from our core business.

If the owners of the intellectual property we license fail to maintain the intellectual property, we may lose our rights to develop our products or product candidates.

We generally do not control the patent prosecution of intellectual property that we license from third parties. Accordingly, we are unable to exercise the same degree of control over this intellectual property as we would exercise over intellectual property that we own, and, as a result, we may lose our rights to such intellectual property and incur substantial costs.

If our employees, consultants and vendors do not comply with their confidentiality agreements or our trade secrets otherwise become known, our ability to generate revenue and profits may be impaired.

Patent prosecution may not be appropriate or obtainable for certain of our technologies, and we may instead protect such proprietary information as trade secrets. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors.

These agreements generally provide that all confidential information developed or made known to an individual or company during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees and consultants, our agreements generally provide that all inventions made by the individual while engaged by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors. If our trade secrets become known, we may lose a competitive advantage and our ability to generate revenue may therefore be impaired.

By working with corporate partners, research collaborators and scientific advisors, we are subject to disputes over intellectual property, and our ability to obtain patent protection or protect proprietary information may be impaired.

Under some of our research and development agreements, inventions discovered in certain cases become jointly owned by our corporate partner and us and in other cases become the exclusive property of one of us. It can be difficult to determine who owns a particular invention, and disputes could arise regarding those inventions. These disputes could be costly and could divert management’s attention from our business. Our research collaborators and scientific advisors have some rights to publish our data and proprietary information in which we have rights. Such publications may impair our ability to obtain patent protection or protect our proprietary information, which could impair our ability to generate revenue.

Risks Related to Our Financial Results and Other Risks Related to Our Business

If we continue to incur net losses for an extended period of time, we may be unable to continue our business.

We have incurred net losses since inception, and our accumulated deficit was approximately $994.0 million at June 30, 2012. We expect to incur substantial additional net losses prior to achieving profitability, if ever. The extent of our future net losses and the timing of our profitability are highly uncertain, and we may never achieve profitable operations. We are planning to expand the number of diseases for which our products may be marketed, and this expansion will require significant expenditures. Through June 2012, we generated revenue primarily through the sale of Actimmune; however, in June 2012, we divested all of our Actimmune assets. We have not generated operating profits to date from our products. If the time required for us to achieve profitability is longer than we anticipate, we may not be able to continue our business.

If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully execute our business plan.

We believe our existing cash, cash equivalents and available-for-sale securities, along with anticipated cash flows from our sales of Esbriet, will be sufficient to fund our operating expenses, debt obligations and capital requirements under our current business plan through at least the next twelve months. However, our current plans and assumptions may change, and our capital requirements may increase. We have no committed sources of capital and do not know whether additional financing will be available when needed, or, if available, that the terms will be favorable to our stockholders or us. If additional funds are not available, we may be forced to delay or terminate clinical trials, curtail operations or obtain funds through collaborative and licensing arrangements that may require us to relinquish commercial rights or potential markets, or grant licenses on terms that are not favorable to us. If adequate funds are not available, we will not be able to successfully execute our business plan.

Budget or cash constraints may force us to delay our efforts to develop certain products in favor of developing others, which may prevent us from meeting our stated timetables and commercializing those products as quickly as possible, or take certain cost saving efforts that could harm our financial results.

Because we are an emerging company with limited resources, and because research and development is an expensive process, we must regularly assess the most efficient allocation of our research and development resources. Accordingly, we may choose to delay our research and development efforts for a promising product candidate or we may elect to terminate our programs for and, in certain cases, our licenses to, such product candidates or programs in order to allocate resources to another program, which could cause us to fall behind our initial timetables for development of certain product candidates. As a result, we may not be able to fully realize the

value of some of our product candidates in a timely manner, since they will be delayed in reaching the market, or may not reach the market at all. If we terminate a preclinical program in which we have invested significant resources, we will have expended resources on a program that will not provide a full return on our investment and missed the opportunity to have allocated those resources to potentially more productive uses.

Due to cash constraints or for strategic business reasons we may decide to take certain actions that reduce our expenses. For example, we sold to Roche our worldwide development and commercialization rights to danoprevir and received $175.0 million from the sale of such rights. On a forward-looking basis we will not incur the expense associated with further investment in danoprevir; however, our rights to share profits from sales of danoprevir in the United States have also been terminated and, as a result, our business and future financial results may be harmed.

Negative conditions in the global markets may impair the liquidity of a portion of our investment portfolio.

Our investment securities consist of high-grade corporate debt securities, government agency securities and direct government obligation securities. Due to recent credit market and global economic conditions, markets for certain fixed-income securities have been volatile and have experienced limitations in liquidity. If there is insufficient demand for the securities we hold, we may not have liquid access to our investments and may be required to recognize an impairment for those securities should we conclude that such impairment is other-than-temporary. For example, as recently as September 30, 2010 we held in our investment portfolio $4.8 million of auction rate securities that had experienced illiquid market conditions requiring us to previously adjust the carrying-value of these securities. As of December 31, 2010, all of our auction rate securities had been sold or redeemed.

Failure to accurately forecast demand for our products could result in additional charges for excess inventories or non-cancelable purchase obligations or supply shortages.

We initiated our commercial launch of Esbriet in Germany in September 2011, and we currently plan to initiate commercial launches in additional countries in the EU in 2012. While we have attempted to forecast demand for Esbriet in Germany and the EU, until we have a sufficient history of commercial sales in such jurisdictions, we cannot know with certainty whether our inventory of Esbriet is in excess of or insufficient to meet demand. Further, we have just recently established our sales organization in the EU and we do not yet know if the size of the sales organization is sufficient to successfully commercialize Esbriet, which makes accurately forecasting demand more difficult. If we fail to accurately forecast demand for Esbriet, we may face temporary supply shortages, which would impair our ability to generate revenue from such demand, or excess inventories, which may result in additional charges for such excess inventory.

If product liability lawsuits are brought against us, we may incur substantial liabilities.

The testing, marketing and sale of medical products entail an inherent risk of product liability. We have product liability risk for all of our product candidates and for all of the clinical trials we conduct, including our discontinued INSPIRE trial. If product liability costs exceed our liability insurance coverage, we may incur substantial liabilities. Whether or not we were ultimately successful in product liability litigation, such litigation would consume substantial amounts of our financial and managerial resources, and might result in adverse publicity, all of which would impair our business. While we believe that our clinical trial and product liability insurance currently provides adequate protection to our business, we may not be able to maintain our clinical trial insurance or product liability insurance at an acceptable cost, if at all, and this insurance may not provide adequate coverage against potential claims or losses.

If we materially breach the representations and warranties we made to Roche under the asset purchase agreement for the sale of danoprevir or to Vidara under the asset purchase agreement for the sale of Actimmune, or if we fail to perform any of our other contractual obligations under these agreements, Roche or Vidara, as applicable, has the right to seek indemnification from us for damages it suffers as a result of such breach or failure. These amounts could be significant.

We have agreed to indemnify Roche and its affiliates against losses suffered as a result of our material breach of representations and warranties and our other obligations in the asset purchase agreement for our sale of our worldwide development and commercialization rights to danoprevir. In addition, we have agreed to indemnify Vidara and its affiliates against losses suffered as a result of our material breach of representations and warranties and our other obligations in the asset purchase agreement for the sale of our worldwide development and commercialization rights to Actimmune^®. If one or more of our representations and warranties were not true at the time we made them to Roche or Vidara, or if we fail to perform any of our other contractual obligations under an agreement, we would be in breach of the applicable asset purchase agreement. In the event of a breach or failure by us to perform, Roche or Vidara, as applicable, has the right to seek indemnification from us for damages suffered by either of them as a result of such breach. The amounts for which we could become liable may be significant.

Our use of hazardous materials, chemicals, viruses and radioactive compounds exposes us to potential liabilities.

Our research and development activities involve the controlled use and disposal of hazardous materials, chemicals, infectious disease agents and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for significant damages or fines, which may not be covered by or may exceed our insurance coverage.

Insurance coverage is increasingly difficult to obtain or maintain.

While we currently maintain clinical trial and product liability insurance, directors’ and officers’ liability insurance, general liability insurance, property insurance and warehouse and transit insurance, first- and third-party insurance is increasingly more costly and narrower in scope, and we may be required to assume more risk in the future. If we are subject to third-party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to share that risk in excess of our insurance limits. Furthermore, any first- or third-party claims made on our insurance policies may impact our future ability to obtain or maintain insurance coverage at reasonable costs, if at all.

Failure to attract, retain and motivate skilled personnel and cultivate key academic collaborations will delay our product development programs and our business development efforts.

As of June 30, 2012, we had 216 full-time employees, and our success depends on our continued ability to attract, retain and motivate highly qualified management, scientific and commercial personnel, especially in Europe, and on our ability to develop relationships with leading academic scientists. Competition for personnel and academic collaborations is intense. We are highly dependent on our current management and key scientific and technical personnel, including Daniel G. Welch, our Chairman, Chief Executive Officer and President, as well as the other principal members of our management. None of our employees, including members of our management team, has a long-term employment contract, and any of our employees can leave at any time. Our success will depend in part on retaining the services of our existing management and key personnel and attracting and retaining new highly qualified personnel. In addition, we may need to hire additional personnel and develop additional academic collaborations if we expand our research and development activities. We do not know if we will be able to attract, retain or motivate personnel or cultivate academic collaborations. Our inability to hire, retain or motivate qualified personnel or cultivate academic collaborations would harm our business.

Our ability to use our net operating losses and certain other tax attributes may be subject to annual limitations under federal and state tax law that could materially affect our ability to utilize such losses and attributes.

If a corporation undergoes an “ownership change” within the meaning of section 382 of the Internal Revenue Code, or section 382, the corporation’s ability to utilize any net operating losses, or NOLs, and certain tax credits and other attributes generated before such an ownership change, is limited. We believe that we have in the past experienced ownership changes within the meaning of section 382 that have resulted in limitations under section 382 (and similar state provisions) on the use of our NOLs and other tax attributes. Future changes in ownership could result in additional ownership changes within the meaning of section 382 that could further limit our ability to utilize our NOLs and certain other tax attributes.

Risks Related to our Securities

Our significant level of indebtedness could limit cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under our outstanding notes.

We have now and will continue to have, a significant amount of indebtedness. As of June 30, 2012, we had $85.0 million of outstanding indebtedness under our 2015 Notes and $155.3 million indebtedness under our 2018 Notes. We may also incur additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences for our business, results of operations and financial condition, including:

•

increasing our vulnerability to adverse economic and industry conditions;

•

limiting our ability to obtain additional financing;

•

requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes;

•

limiting our flexibility in planning for, or reacting to, changes in our business;

•

dilution experienced by our existing stockholders as a result of the conversion of our 2015 Notes into shares of common stock; and

•

placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources.

As of June 30, 2012, our annual debt service obligation on our 2015 and 2018 Notes was $8.1 million. We cannot assure you that we will continue to maintain sufficient cash reserves or that our business will continue to generate cash flow from operations at levels sufficient to permit us to pay principal, premium, if any, and interest on our indebtedness, or that our cash needs will not increase. If we are unable to generate sufficient cash flow or otherwise obtain funds necessary to make required payments, or if we fail to comply with the various requirements of our outstanding notes or any indebtedness which we may incur in the future, we would be in default, which would permit the holders of the affected notes or other indebtedness to accelerate the maturity of such notes or other indebtedness and could cause defaults under the company’s other notes and indebtedness. Any default under our notes or any indebtedness which we may incur in the future could have a material adverse effect on our business, results of operations and financial condition.

We may fail to meet our publicly announced financial guidance or other expectations about our business, which would cause our stock to decline in value and affect the trading price of our outstanding notes.

There are a number of reasons why we might fail to meet our financial guidance or other expectations about our business, including, but not limited to, the following:

•

negative developments or setbacks in our application to obtain marketing approval for pirfenidone in the United States, including negative results of the ASCEND trial that we initiated in the second quarter of 2011, slower than anticipated enrollment in the ASCEND trial and/or a negative response from the FDA to our anticipated NDA resubmission based on data from this trial;

•

delays or unexpected difficulties in our commercial launch of Esbriet in the EU;

•

lower than expected pricing and reimbursement levels for Esbriet in the EU, including any adverse decisions by Germany’s Federal Joint Commission stemming from the IQWiG benefit assessment;

•

negative developments with regard to the recently commenced litigation with Shionogi:

•

if only a subset of or no affected patients respond to therapy with any of our products or product candidates;

•

the actual dose or efficacy of the product for a particular condition may be different than currently anticipated;

•

negative publicity about the results of our clinical studies, such as the failure of pirfenidone to meet its primary endpoint and the PFS secondary endpoint in the CAPACITY 1 trial, or those of others with similar or related products may reduce demand for our products and product candidates;

•

the treatment regimen may be different in duration than currently anticipated;

•

treatment may be sporadic;

•

we may not be able to sell a product at the price we expect;

•

we may not be able to accurately calculate the number of patients using the product;

•

we may not be able to supply enough product to meet demand;

•

there may be current and future competitive products that have greater acceptance in the market than our products do;

•

we may decide to divest a product;

•

our development activities may proceed faster than planned;

•

we may decide to change our marketing and educational programs; or

•

clinical trial participation may reduce product sales.

If we fail to meet our revenue and/or expense projections and/or other financial guidance for any reason, our stock could decline in value. The market price of our common stock, as well as the general level of interest rates and our credit quality, will likely significantly affect the trading price of our notes.

Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our stock price and the trading price of our outstanding notes.

Section 404 of the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the Securities and Exchange Commission, or the Commission, require an annual management assessment of the effectiveness of our internal control over financial reporting and a report by our independent registered public accounting firm attesting to the effectiveness of our internal control over financial reporting at the end of the fiscal year. If we fail to maintain the adequacy of our internal control over financial reporting, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the Commission. If we cannot in the future favorably assess, or our independent registered public accounting firm is unable to provide an unqualified attestation report on, the effectiveness of our internal control over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could have a material adverse effect on our stock price and the trading price of our outstanding notes.

Substantial sales of shares or the issuance of additional stock may negatively impact the market price of our common stock and the trading price of our outstanding notes.

If our stockholders sell substantial amounts of our common stock, including shares issued upon the exercise of outstanding options or conversion of our outstanding notes, the market price of our common stock and, in turn, the trading price of our notes, may decline. In addition, the existence of our notes may encourage short selling by market participants. These sales also might make it more difficult for us to sell equity or equity related securities in the future at a time and price that we deem appropriate. We are unable to predict the effect that sales may have on the then-prevailing market price of our common stock and the trading price of our outstanding notes.

We have filed registration statements covering the approximately 7.8 million shares of common stock that are either issuable upon the exercise of outstanding options or reserved for future issuance pursuant to our stock plans as of June 30, 2012.

As of June 30, 2012, we had an aggregate of approximately 17.1 million shares of common stock authorized but unissued and not reserved for issuance under our option and compensation plans or under other convertible or derivative instruments. We may issue all of these shares without any action or approval by our stockholders. The issuance of these unreserved shares in connection with acquisitions or otherwise, as well as any shares of our common stock issued in connection with the exercise of stock options, restricted stock units, under convertible or derivative instruments or otherwise would dilute the notional percentage ownership held by the our security holders. In addition, we may issue a substantial number of shares of our common stock upon conversion of our outstanding notes.

At times, the market price of our common stock has fluctuated significantly, and as a result an investment in our stock could decline in value. Future fluctuations in our stock price may also impact the trading price of our outstanding notes and make them more difficult to resell.

The market price of our common stock has been and is likely to continue to be extremely volatile. During the twelve-month period ended June 30, 2012, the closing price of our common stock on The NASDAQ Global Select Market ranged from a high of $37.15 in July 2011 to a low of $9.72 in June 2012. The market price of our common stock could be subject to wide fluctuations in response to a variety of factors, many of which we cannot control, including:

•

general economic and political conditions and specific conditions in the biotechnology industry;

•

changes in expectations as to our future financial performance, including financial estimates or publication of research reports by securities analysts;

•

strategic actions taken by us or our competitors, such as acquisitions or restructurings;

•

announcements of new products or technical innovations by us or our competitors;

•

actions taken by institutional shareholders; and

•

speculation in the press or investment community.

In addition, the stock market in general, and the stock price of companies listed on NASDAQ, and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of actual operating performance. Periods of volatility in the market price of a company’s securities frequently results in securities class action and shareholder derivative litigation against that company. This type of litigation can result in substantial costs and a diversion of management’s attention and resources.

Because our outstanding notes are convertible into shares of our common stock, volatility or depressed market prices of our common stock could have a similar effect on the trading price of our outstanding notes. Holders who receive shares of our common stock upon conversion of our notes will also be subject to the risk of volatility and depressed market prices of our common stock.

Provisions of Delaware law, our charter documents and the indentures governing our outstanding notes may impede or discourage a takeover, which could cause the market price of our common stock to decline.

Provisions of our Amended and Restated Certificate of Incorporation and Bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions:

•

establish a classified board of directors so that not all members of our board may be elected at one time;

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authorize the issuance of up to 5,000,000 shares of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and hinder a takeover attempt;

•

limit who may call a special meeting of stockholders;

•

prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and

•

establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings.

In addition, Section 203 of the Delaware General Corporation Law, which prohibits business combinations between us and one or more significant stockholders unless specified conditions are met, may discourage, delay or prevent a third party from acquiring us.

The repurchase rights in our outstanding notes triggered by the occurrence of a fundamental change and the additional shares of our common stock by which the conversion rates are increased in connection with certain make-whole fundamental change transactions could also discourage a potential acquirer.

We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

We have never declared or paid any dividends on our capital stock. We currently intend to retain all of our future earnings, if any, to finance our operations and do not anticipate paying any cash dividends on our capital stock in the foreseeable future. As a result, holders who convert their notes and receive shares of our common stock will not realize a return on their investment unless the market price of our common stock appreciates, which we cannot assure.

Item 6.

Exhibits.


Exhibit Number		Description of Document

2.1(a)		Asset Purchase Agreement by and among Vidara Therapeutics International Limited, Vidara Therapeutics Holdings LLC, Vidara Therapeutics Research Limited and InterMune, dated May 17, 2012.(1)

2.1(b)		Amendment to Asset Purchase Agreement, dated June 18, 2012, by and among Vidara Therapeutics International Limited, Vidara Therapeutics Holdings LLC, Vidara Therapeutics Research Limited and InterMune. (1)

3.1		Amended and Restated Certificate of Incorporation of InterMune.(2)

3.2		Certificate of Ownership and Merger, dated April 26, 2001.(3)

3.3		Amended and Restated Bylaws of InterMune.(4)

3.4		Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(5)

3.5		Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(6)

3.6		Certificate of Amendment of Amended and Restated Certificate of Incorporation of Registrant. (7)

3.7		Certificate of Designation of Series A Junior Participating Preferred Stock. (8)

4.1		Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7.

4.2		Specimen Common Stock Certificate. (2)

4.3		Indenture, dated as of February 17, 2004, between Registrant and The Bank of New York. (9)

4.4		Registration Rights Agreement, dated as of February 17, 2004, among Registrant, Morgan Stanley & Co. Incorporated, Banc of America Securities LLC, Credit Suisse First Boston LLC, Harris Nesbitt Corp. and RBC Capital Markets Corporation. (9)

4.5		Indenture, dated as of June 24, 2008, between Registrant and The Bank of New York Trust Company, N.A. (10)

4.6		Form of 5.00% Convertible Senior Note due 2015 (included in Exhibit 4.5). (10)

4.7		Indenture, dated September 19, 2011, between the Registrant and The Bank of New York Mellon Trust Company, N.A., as Trustee. (11)

4.8		First Supplemental Indenture, dated September 19, 2011, between the Registrant and The Bank of New York Mellon Trust Company, N.A., as Trustee (including the form of 2.50% convertible senior note due 2018). (11)

10.1		Amended and Restated 2000 Equity Incentive Plan.(12)

31.1		Certification required by Rule 13a-14(a) or Rule 15d-14(a).(1)

31.2		Certification required by Rule 13a-14(a) or Rule 15d-14(a).(1)

32.1*		Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350).(1)

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Definition Linkbase Document



101.LAB		XBRL Taxonomy Extension Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

(1)	Filed herewith.

(2)

Filed as an exhibit to InterMune’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on February 2, 2000 (No. 333-96029), as amended by Amendment No. 1 filed with the Commission on February 18, 2000, as amended by Amendment No. 2 filed with the Commission on March 6, 2000, as amended by Amendment No. 3 filed with the Commission on March 22, 2000, as amended by Amendment No. 4 filed with the Commission on March 23, 2000 and as amended by Amendment No. 5 filed with the Commission on March 23, 2000.

(3)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2001.

(4)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on March 24, 2010.

(5)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2003.

(6)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004.

(7)	Filed as an exhibit to Registrant’s Registration Statement on Form S-3 filed with the Commission on September 4, 2009 (No. 333-161758).

(8)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on July 18, 2001.

(9)	Filed as an exhibit to the Registrant’s amended Annual Report on Form 10-K/A (Amendment No. 1) for the year ended December 31, 2003 filed on May 14, 2004.

(10)	Filed as an exhibit to the Registrant’s Current Report on Form 8-K on June 24, 2008.

(11)	Filed as an exhibit to the Registrant’s Current Report on Form 8-K on September 19, 2011.

(12)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on June 8, 2012.

*	This certification accompanies the Periodic Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


InterMune, Inc.

By:		/s/ John C. Hodgman
John C. Hodgman Chief Financial Officer and Senior Vice President, Finance

Date: August 7, 2012

INDEX TO EXHIBITS


Exhibit Number		Description of Document

2.1(a)		Asset Purchase Agreement by and among Vidara Therapeutics International Limited, Vidara Therapeutics Holdings LLC, Vidara Therapeutics Research Limited and InterMune, dated May 17, 2012.(1)

2.1(b)		Amendment to Asset Purchase Agreement, dated June 18, 2012, by and among Vidara Therapeutics International Limited, Vidara Therapeutics Holdings LLC, Vidara Therapeutics Research Limited and InterMune. (1)

3.1		Amended and Restated Certificate of Incorporation of InterMune.(2)

3.2		Certificate of Ownership and Merger, dated April 26, 2001.(3)

3.3		Amended and Restated Bylaws of InterMune.(4)

3.4		Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(5)

3.5		Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(6)

3.6		Certificate of Amendment of Amended and Restated Certificate of Incorporation of Registrant. (7)

3.7		Certificate of Designation of Series A Junior Participating Preferred Stock. (8)

4.1		Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7.

4.2		Specimen Common Stock Certificate. (2)

4.3		Indenture, dated as of February 17, 2004, between Registrant and The Bank of New York. (9)

4.4		Registration Rights Agreement, dated as of February 17, 2004, among Registrant, Morgan Stanley & Co. Incorporated, Banc of America Securities LLC, Credit Suisse First Boston LLC, Harris Nesbitt Corp. and RBC Capital Markets Corporation. (9)

4.5		Indenture, dated as of June 24, 2008, between Registrant and The Bank of New York Trust Company, N.A. (10)

4.6		Form of 5.00% Convertible Senior Note due 2015 (included in Exhibit 4.5). (10)

4.7		Indenture, dated September 19, 2011, between the Registrant and The Bank of New York Mellon Trust Company, N.A., as Trustee. (11)

4.8		First Supplemental Indenture, dated September 19, 2011, between the Registrant and The Bank of New York Mellon Trust Company, N.A., as Trustee (including the form of 2.50% convertible senior note due 2018). (11)

10.1		Amended and Restated 2000 Equity Incentive Plan.(12)

31.1		Certification required by Rule 13a-14(a) or Rule 15d-14(a).(1)

31.2		Certification required by Rule 13a-14(a) or Rule 15d-14(a).(1)

32.1*		Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350).(1)

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Definition Linkbase Document



101.LAB		XBRL Taxonomy Extension Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

(1)	Filed herewith.

(2)

(3)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2001.

(4)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on March 24, 2010.

(5)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2003.

(6)	Filed as an exhibit to InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004.

(7)	Filed as an exhibit to Registrant’s Registration Statement on Form S-3 filed with the Commission on September 4, 2009 (No. 333-161758).

(8)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on July 18, 2001.

(9)	Filed as an exhibit to the Registrant’s amended Annual Report on Form 10-K/A (Amendment No. 1) for the year ended December 31, 2003 filed on May 14, 2004.

(10)	Filed as an exhibit to the Registrant’s Current Report on Form 8-K on June 24, 2008.

(11)	Filed as an exhibit to the Registrant’s Current Report on Form 8-K on September 19, 2011.

(12)	Filed as an exhibit to InterMune’s Current Report on Form 8-K filed with the Commission on June 8, 2012.

*	This certification accompanies the Periodic Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

EX-2.1A 2 d370181dex21a.htm ASSET PURCHASE AGREEMENT Asset Purchase Agreement

Exhibit 2.1A

Execution Copy

ASSET PURCHASE AGREEMENT

by and among

Vidara Therapeutics International Limited

(as Purchaser),

Vidara Therapeutics Holdings LLC

(as Parent),

Vidara Therapeutics Research Limited

(as Opco)

and

InterMune, Inc.

(as Seller)

May 17, 2012

TABLE OF CONTENTS


		Page
ARTICLE I
Definitions

Section 1.1	Defined Terms		1
Section 1.2	Construction		13

ARTICLE II
The Transaction

Section 2.1	Purchase and Sale of Purchased Assets		14
Section 2.2	Excluded Assets		15
Section 2.3	Assumed Liabilities		15
Section 2.4	Excluded Liabilities		16
Section 2.5	Closing Date		16
Section 2.6	Purchaser Obligations		16
Section 2.7	Seller Obligations		17
Section 2.8	Allocation of Purchase Price		17
Section 2.9	Assignability and Consents		18
Section 2.10	License Grant		18

ARTICLE III
Representations and Warranties of Seller

Section 3.1	Organization and Authority		19
Section 3.2	Purchased Assets; Title to Purchased Assets.		19
Section 3.3	Consents; Non-Contravention		19
Section 3.4	Regulatory Approvals		20
Section 3.5	Compliance with Laws and Litigation		20
Section 3.6	No Material Adverse Change		21
Section 3.7	Assumed Contracts		21
Section 3.8	Inventory and Returns.		22
Section 3.9	Tax Matters		22
Section 3.10	Intellectual Property		23
Section 3.11	Product Records		24
Section 3.12	Brokers, Finders, etc.		24
Section 3.13	Financial Statements		25
Section 3.14	Insurance		25
Section 3.15	Regulatory Compliance		25
Section 3.16	No Other Warranties		27


ARTICLE IV
Representations and Warranties of Purchaser

Section 4.1	Organization and Authority	27
Section 4.2	Consents; No Violations	28
Section 4.3	Brokers, Finders, etc.	28
Section 4.4	Financing	28
Section 4.5	Litigation	28

ARTICLE V
Covenants of Seller Prior to Closing

Section 5.1	Conduct of the Product Business Prior to Closing	29
Section 5.2	Notice of Default	29
Section 5.3	No Negotiation	29
Section 5.4	Commercially Reasonable Efforts	29
Section 5.5	Notice of Government Investigations	30

ARTICLE VI
Covenants of Purchaser and Parent Prior to Closing

Section 6.1	Notice of Default	30
Section 6.2	Commercially Reasonable Efforts	30

ARTICLE VII
Closing and Termination

Section 7.1	Conditions Precedent to Obligations of Parties	30
Section 7.2	Conditions Precedent to Purchaser’s Obligations	30
Section 7.3	Conditions Precedent to Seller’s Obligations	31
Section 7.4	Termination	32
Section 7.5	Procedure and Effect of Termination	32

ARTICLE VIII
Certain Other Covenants

Section 8.1	Necessary Efforts; No Inconsistent Action	32
Section 8.2	Public Disclosures	34
Section 8.3	Product Returns, Rebates and Chargebacks	34
Section 8.4	Transitional Trademark License	34
Section 8.5	Customer Billing	35
Section 8.6	Cooperation	35
Section 8.7	Reserved	36
Section 8.8	Tax Matters	36
Section 8.9	Notice to Customers	37
Section 8.10	Adverse Experience Reports	37
Section 8.11	Regulatory Matters	37
Section 8.12	Product Records	38


Section 8.13	Employees	38
Section 8.14	Non-Competition	38
Section 8.15	Seller’s Additional Covenants and Agreements	40

ARTICLE IX
Indemnification

Section 9.1	Indemnification	41
Section 9.2	Certain Limitations	42
Section 9.3	Procedures for Third Party Claims and Excluded Liabilities	43
Section 9.4	Certain Procedures	46
Section 9.5	Guaranty	46
Section 9.6	Remedies Exclusive	46

ARTICLE X
Miscellaneous Provisions

Section 10.1	Confidentiality	46
Section 10.2	Notices	48
Section 10.3	Bulk Transfers	49
Section 10.4	Remedies Cumulative; Specific Performance	49
Section 10.5	Further Assurances; Further Cooperation	49
Section 10.6	Amendments and Waivers	50
Section 10.7	Expenses	50
Section 10.8	Binding Effect; Benefit; Assignment	50
Section 10.9	Governing Law	51
Section 10.10	Jurisdiction	51
Section 10.11	Waiver of Jury Trial	51
Section 10.12	Arbitration	52
Section 10.13	Counterparts; Effectiveness	52
Section 10.14	Entire Agreement	53
Section 10.15	Severability	53
Section 10.16	Time is of the Essence	53

iii

ASSET PURCHASE AGREEMENT

This ASSET PURCHASE AGREEMENT (as amended from time to time, the “Agreement”), dated as of May 17, 2012 (the “Agreement Date”), is made and entered into by and among Vidara Therapeutics International Limited, an Irish company (“Purchaser”), Vidara Therapeutics Holdings LLC, a Delaware limited liability company (“Parent”), Vidara Therapeutics Research Limited, an Irish company (“Opco”) and InterMune, Inc., a Delaware corporation (“Seller”). Purchaser, Parent, Opco and Seller are sometimes collectively referred to herein as the “Parties” and separately as a “Party.”

RECITALS

WHEREAS, Seller is a biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology;

WHEREAS, Purchaser is a biopharmaceutical company focused on the development and commercialization of differentiated specialty products to treat unmet medical needs;

WHEREAS, Seller has determined that the sale of certain products and product related intellectual property rights at this time is consistent with its current business strategy;

WHEREAS, Purchaser has determined that the acquisition of those certain products and product related intellectual property rights at this time is consistent with its current business strategy;

WHEREAS, Purchaser is a wholly-owned subsidiary of Parent and Opco is a wholly-owned, indirect subsidiary of Purchaser; and

WHEREAS, Seller desires to sell such products and product-related intellectual property rights to Purchaser, and Purchaser desires to purchase such products and product-related intellectual property rights from Seller, on the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the promises, representations, warranties, covenants and agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound hereby, agree as follows:

ARTICLE I

DEFINITIONS

Section 1.1 Defined Terms. For the purposes of this Agreement, the following words and phrases shall have the following meanings whether in the singular or the plural:

“AAA” shall have the meaning set forth in Section 10.12(a).

“Acquisition Proposal” shall mean an indication of interest, offer or proposal to acquire Seller’s right, title and interest in and to all or any substantial portion of the Purchased Assets in a single transaction or series of related transactions (other than the transactions provided for in this Agreement).

“Additional Intellectual Property” shall have the meaning set forth in Section 8.15(c).

“Affiliate” shall mean with respect to any Person, any other Person which controls, is controlled by, or is under common control with such Person. For purposes of this definition, a Person shall be regarded as in control of another Person if it owns or controls, directly or indirectly, (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Person; and (ii) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) (or the maximum ownership interest permitted by law) of the equity interest or the power to direct the management and policies of such non-corporate entities.

“Agreement” shall have the meaning set forth in the first paragraph of this Agreement.

“Agreement Date” shall mean the date set forth in the first paragraph of this Agreement.

“Allocation Schedule” shall have the meaning set forth in Section 2.8.

“Alternate Seller Bank Account” shall have the meaning set forth in Section 2.1(b)(ii)(A).

“Ancillary Agreements” shall mean the Assignment and Assumption Agreements, the Bills of Sale, the Domain Name Assignment Agreement, the Patent Assignment Agreement and the Transition Services Agreement.

“Annual Period” shall mean a twelve (12) month period measured from the Closing Date, or an anniversary of the Closing Date, to the next anniversary of the Closing Date.

“Antitrust Regulations” shall mean the HSR Act and any other Applicable Laws or regulations relating to antitrust or competition.

“Applicable Law” shall mean all applicable provisions of all statutes, Laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents, injunctions, awards, judgments, and permits and licenses of or from Governmental Authorities relating to or governing the use or regulation of the subject item.

“Assignment and Assumption Agreements” shall mean those certain assignment and assumption agreements in the form attached hereto as Exhibit B.

“Assumed Contracts” shall mean (i) the Contracts identified on Schedule 1.1(d) and (ii) any purchase orders for Product received by Seller or its Affiliates prior to the Closing Date, but not shipped prior to 11:59 p.m., PDT, on the day prior to the Closing Date.

“Assumed Liabilities” shall mean the Liabilities set forth in Section 2.3.

“B-I Purchase Orders” shall mean (i) that certain Purchase Order No. PO10395, dated as of May 2, 2012, submitted by Seller to Boehringer-Ingelheim and (ii) that certain Purchase Order No. PO10396, dated as of May 2, 2012, submitted by Seller to Boehringer-Ingelheim, both of which are appended hereto as Exhibit F.

“B-I Supply Agreement” shall mean the Supply Agreement between Seller and Boehringer-Ingelheim dated as of June 29, 2007, as amended and restated as of May 15, 2012, providing for the manufacture and supply of the Product, attached as part of Exhibit E.

“Basket Amount” shall have the meaning set forth in Section 9.2(a).

“Bills of Sale” shall mean those certain bills of sale in the forms attached hereto as Exhibit A.

“Boehringer-Ingelheim” shall mean Boehringer Ingelheim Austria GmbH or its successor-in-interest Boehringer Ingelheim RCV GmbH & Co KG.

“Business Day” shall mean a day, which is not a Saturday, a Sunday, or a statutory holiday in the United States.

“Cap” shall have the meaning set forth in Section 9.2(c).

“Chargebacks” shall mean chargebacks and similar payments to wholesalers and other distributors in connection with the Product.

“Closing” shall have the meaning set forth in Section 2.5.

“Closing Cash Payment” shall have the meaning set forth in Section 2.1(b)(i).

“Closing Date” shall have the meaning set forth in Section 2.5.

“Code” shall mean the United States Internal Revenue Code of 1986, as amended.

“Commercial Rebates” shall mean rebates to commercial customers.

“Competing Product” shall mean any product that is or is being developed to be a generic equivalent of, a generic formulation of, biosimilar or interchangeable with the Product where “biosimilar” and “interchangeable” shall have the meaning ascribed to them under the Biosimilars Act 42 USC 262(i).

“Confidentiality Agreement” shall have the meaning set forth in Section 10.1(a).

“Confidential Information” shall mean Purchaser Confidential Information and Seller Confidential Information.

“Consent” shall have the meaning set forth in Section 2.9.

“Contract” shall mean any agreement, contract, lease, consensual obligation, promise, or undertaking (whether written or oral), to which Seller or any of its Affiliates is a party (i) that

relates solely or primarily to the Product, the Product Business, the Purchased Assets or the Assumed Liabilities, or (ii) that, to the extent related to the Product, is necessary for the conduct of the Product Business as conducted by Seller.

“Controlled” shall mean, with respect to any of the Inventory, any of the Product Intellectual Property and any of the Product Records, that is owned or licensed (as licensor or licensee) by Seller and/or any of its Affiliates, and in which Seller has the legal authority or right to grant, convey, transfer and assign to Purchaser, all of Seller’s (and any of its Affiliates’) rights, titles and interests therein and thereto.

“Copyright” shall mean U.S., international or foreign copyrights, including any and all Copyright Registrations and Applications therefor, and all exclusive rights under all such copyrights, for, in and to, or otherwise based upon any and all documents, website content, data, artwork, advertising materials, product packaging, product labels, product packaging inserts and product instructions.

“Copyright Registrations and Applications” shall mean U.S., international or foreign copyright registrations, recordations and applications, and any and all renewals, extensions and reversions thereof, for which a registration or serial number may be, has been or will be assigned by the relevant Governmental Authority.

“Dispute” shall have the meaning set forth in Section 10.12(a).

“Domain Name Assignment Agreement” shall mean that certain domain name and webpages assignment agreement in the form attached hereto as Exhibit G.

“Domain Names” shall mean any and all Internet domain names, websites and URLs, and any and all applications and registrations therefor.

“Earnout” shall have the meaning set forth in Section 2.1(b)(ii)(A).

“Encumbrance” shall mean claims, security interests, liens, pledges, charges, escrows, options, proxies, rights of first refusal, preemptive rights, covenants not to sue, mortgages, hypothecations, assessments, prior assignments, reversionary rights, reversionary titles, reversionary interests, title retention agreements, conditional sales agreements, indentures, deeds of trust, leases, levys or security agreements of any kind whatsoever, or any other agreements to give any of the foregoing in the future, imposed upon the subject property or item.

“Environmental Law” shall mean any applicable Law relating directly or indirectly to (i) the protection of the environment (including air, water vapor, surface water, groundwater, drinking water supply, surface or subsurface land), (ii) occupational health and safety or (iii) the exposure to, or the use, storage, recycling, treatment, generation, transportation, processing, handling, labeling, recycling, release or disposal of, hazardous materials.

“Exchange Act” shall have the meaning set forth in Section 3.13(a).

“Excluded Assets” shall mean all assets and properties (other than the Purchased Assets) of Seller and its Affiliates, including without limitation the Excluded Data and Materials.

“Excluded Claim” shall mean any dispute, controversy or claim arising from or related to (i) any of the representations, warranties, covenants, agreements and/or provisions set forth in Sections 3.10, 8.14 and/or 8.15 of this Agreement, and any inaccuracy or breach thereof, (ii) any of the representations, warranties, covenants, agreements and/or provisions of this Agreement that relate to the Product Intellectual Property and any inaccuracy or breach thereof and (iii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

“Excluded Data and Materials” shall mean all case report forms, data, reports, publications, abstracts and other information, materials and patient samples generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis.

“Excluded Liabilities” shall have the meaning set forth in Section 2.4(a).

“FDA” shall mean the United States Food and Drug Administration or any successor organization.

“Financial Data” shall have the meaning set forth in Section 3.13(c).

“GAAP” shall mean United States generally accepted accounting principles.

“Genentech License” shall mean the License Agreement for Interferon Gamma between Connectics Corporation and Genentech, Inc. dated as of May 5, 1998, as amended.

“Genentech Patents” shall mean the Patent Rights granted pursuant to the Genentech License.

“Governmental Authority” shall mean the government of the applicable country in the Territory and any state, province, municipality or other political subdivision thereof or therein, or any court, tribunal, judiciary body, agency, department, board, instrumentality, panel, dispute resolution agency, patent office, trademark office, copyright office and any official authority or commission (including regulatory and administrative bodies) of any of the foregoing.

“HIPAA” shall have the meaning set forth in Section 3.15(b).

“HITECH” shall have the meaning set forth in Section 3.15(b).

“HSR Act” shall have the meaning set forth in Section 8.1(b).

“Indemnification Claim Notice” shall have the meaning set forth in Section 9.4.

“Indemnified Party” shall mean the Seller Indemnified Parties or the Purchaser Indemnified Parties, as applicable, in accordance with the terms of this Agreement.

“Indemnifying Party” shall mean the Purchaser, Parent or the Seller, as applicable, in accordance with the terms of this Agreement.

“Intellectual Property” shall mean the Copyrights, Domain Names, Know-How, Patent Rights, Trademarks and Trade Secrets.

“Interferon Gamma-1b” shall mean the amino acid sequence and description set forth on Exhibit 1 to the Seller Disclosure Schedule.

“Inventory” shall mean the Product, and all active pharmaceutical ingredients which are used solely or primarily in the production of the Product, that are owned or Controlled by Seller or its Affiliates on the Closing Date for Seller’s marketing and sale and which (i) are of a quality usable and salable in the ordinary course of business and (ii) in the case of the Product, comprise all unsold lots.

“IPF Patient Data” shall mean data accessible through Seller’s Product regulatory safety database (e.g., the annual safety update reports provided by Seller to the FDA contained therein) and the ARISg global safety database maintained by Seller, which data exists at the time such databases are transferred by Seller to Purchaser after the Closing and which may include, among other things, safety data generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis; provided, however, that for purposes of clarity, IPF Patient Data shall not be deemed to include any case report forms, data (other than the data accessible through Seller’s regulatory safety database and the ARISg global safety database described herein), reports (other than the annual safety update reports described herein), publications, abstracts and other information, materials and patient samples generated by or for Seller or its Affiliates in the conduct of the clinical development of Interferon Gamma-1b for the treatment of patients with idiopathic pulmonary fibrosis.

“IRS” shall mean the United States Internal Revenue Service.

“Know-How” shall mean confidential or proprietary information, including, without limitation, Trade Secrets, inventions (whether or not patentable), discoveries, developments, improvements, enhancements, concepts, ideas, methods, processes, designs, schematics, drawings, formulae, data, technical data and information, specifications, instructions, research and development information, technology and databases.

“Knowledge of Purchaser” or “to Purchaser’s Knowledge” or any similar such statement shall mean Bala Venkataraman, Virinder Nohria, Rick McElheny and Brian Anderson, or any executive officer or director of Purchaser or Parent, directly involved on behalf of Purchaser or Parent in the transactions contemplated herein, has or had actual knowledge, or such knowledge as would be reasonably expected to have been obtained after reasonable inquiry, of a fact or matter.

“Knowledge of Seller” or “to Seller’s Knowledge” or any similar such statement shall mean Lawrence Kahn, Yip Fong Chia, Carla Fiankin, Sandy Mohan, Frank Zampella, and Bruce Tomlinson, or any executive officer of Seller directly involved in the Product Business, has or had actual knowledge, or such knowledge as would be reasonably expected to have been obtained after reasonable inquiry, of a fact or matter.

“Law” shall mean any foreign, federal, state or local law, statute or any rule, or regulation promulgated by any Governmental Authority.

“Liability” shall mean, collectively, any liability, indebtedness, guaranty, endorsement, claim, loss, damage, deficiency, cost, expense, obligation, responsibility, or product liability, whether fixed or unfixed, known or unknown, choate or inchoate, liquidated or unliquidated, secured or unsecured, direct or indirect, matured or unmatured, or absolute, contingent or otherwise.

“Losses” shall mean any and all losses, damages, Liabilities, deficiencies, claims, proceedings, causes of action, costs (including reasonable out of pocket costs of investigation) and expenses, including interest, diminution in value, penalties, settlement costs, judgments, awards, fines, costs of mitigation, losses in connection with any Environmental Law (including any clean up or remedial action), court costs and fees (including reasonable attorneys’ fees and expenses).

“Material Adverse Effect” shall mean any change, circumstance, event or effect that has had or is reasonably likely to have in the future, individually or in the aggregate, a material adverse effect on (i) the condition (financial or otherwise) or results of operation of the Product Business or the Purchased Assets or (ii) the ability of Seller to consummate the transactions contemplated by this Agreement; provided that no changes, circumstances, events or effects resulting from or arising out of the following shall be taken into account in determining whether a Material Adverse Effect has occurred: (a) the public announcement of the entering into of this Agreement or the other Ancillary Agreements or the pendency of the transactions contemplated hereby or thereby (including any cancellation or delay of customer orders, any reduction in sales, any disruption in supplier, partner or similar relationships or any loss of employees), (b) the performance by Seller of any action, or the failure to take any action, in each case at Purchaser’s written request (including email) pursuant to this Agreement or the other Ancillary Agreements, (c) general economic conditions, (d) general conditions in the industry in which the Product Business is conducted, (e) changes in GAAP or Applicable Law which have general application, (f) the failure of the business to meet any internal projections or forecasts of revenue or earnings (provided that the underlying cause of such failure shall be taken into account unless such cause is otherwise included in clause (a) through (e), or (g)), or (g) fire, flood, tornado, earthquake or other acts of nature, acts of terrorism or sabotage, war, regional, national or international calamity, military action or any other similar event or any escalation or worsening thereof after the date hereof, except to the extent, in the case of the foregoing clauses (c) through (e), such changes, circumstances, events or effects referred to therein have a materially disproportionate impact on the Product Business relative to the industry in which the Product Business competes as a whole.

“Opco” shall have the meaning set forth in the first paragraph of this Agreement.

“Parent” shall have the meaning set forth in the first paragraph of this Agreement.

“Party” or “Parties” shall have the meaning set forth in the first paragraph of this Agreement.

“Patent Assignment Agreement” shall mean that certain patent assignment agreement in the form attached hereto as Exhibit D.

“Patent Rights” shall mean U.S., international or foreign patents, provisional patent applications, patent applications, design registrations, design registration applications, industrial designs, industrial design applications and industrial design registrations, including any and all divisions, continuations, continuations-in-part, extensions, substitutions, renewals, registrations, revalidations, reexaminations, reissues or additions, including supplementary certificates of protection, of or to any of the foregoing items.

“Permitted Encumbrances” shall mean (i) Encumbrances for Taxes, assessments and other governmental charges not yet due and payable or, if due, either (a) not delinquent or (b) being contested in good faith by appropriate proceedings, (ii) mechanics’, workmen’s, repairmen’s, warehousemen’s, carriers’ or other similar Encumbrances, including all statutory Encumbrances, arising or incurred in the ordinary course of business and not yet delinquent or, (iii) Encumbrances that do not materially affect the ownership, value or use of the underlying Purchased Asset for the purpose it is being utilized by Seller or its Affiliates on the Closing Date.

“Person” shall mean any natural person, corporation, unincorporated organization, partnership, association, joint stock company, joint venture, limited liability company, trust or government, or any agency or political subdivision of any government, or any other entity.

“Post-Closing Tax Period” shall have the meaning set forth in Section 8.8(c).

“Pre-Closing Tax Period” shall have the meaning set forth in Section 8.8(c).

“Proceeding” shall mean any litigation, claim, action, dispute, lawsuit, arbitration, dispute resolution process, cancellation proceeding, opposition proceeding, concurrent use proceeding, reexamination proceeding, nullification proceeding, interference proceeding, priority contest, challenge, protest, inquiry, change demand, order, judgment, hearing, assessment, or any other proceeding (whether civil, criminal, administrative or investigative), commenced, brought, conducted, or heard by or before any Governmental Authority or arbitrator.

“Product” shall mean the finished pharmaceutical product containing Interferon Gamma-1b in the formulation approved by the FDA for the reduction of the frequency and severity of serious infections related to chronic granulomatous disease and delaying time to disease progression in patients with severe, malignant osteopetrosis and sold by Seller under the Actimmune^® trademark prior to the Closing.

“Product Business” shall mean the manufacturing, using, developing, promoting, advertising, marketing, distributing, selling, offering to sell, importing and/or exporting of the Product in the Territory.

“Product Copyrights” shall mean any and all Copyrights (including, without limitation, any and all Copyright Registrations and Applications listed on Schedule 1.1(c)) that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business.

“Product Domain Names” shall mean any and all active or inactive Domain Names, that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business, as identified on Schedule 1.1(c).

“Product Intellectual Property” shall mean the Product Copyrights, Product Domain Names, Product Know-How, Product Patents, Product Trademarks and Product Trade Secrets, including, without limitation, each of the foregoing as listed on Schedule 1.1(c).

“Product Know How” shall mean any and all Know-How that is Controlled by Seller and/or any of its Affiliates and that relates primarily to the Product and/or the Product Business, excluding the Excluded Data and Materials.

“Product Master Cell Bank” or “PMCB” shall mean collectively the following cell banks relating to the Product or the Product Business: (i) the cell bank stored at Fisher BioServices Inc. located at 14665 Rothgeb Dr., Rockville, Maryland, 20850; and (ii) the working cell bank W3110 pHF CYC5, in each of which Seller or its Affiliates have ownership or other rights or interests, whether contractual or otherwise, therein or with respect thereto.

“Product Master Cell Bank Records” shall mean all records and associated agreements with third party providers relating to the development, characterization and validation of the PMCB and documenting storage, dispensing and periodic testing of Product Master Cell Bank confirming its integrity and stability, that are owned or Controlled by Seller or its Affiliates.

“Product Net Sales” shall mean the gross amount invoiced by Purchaser or its Affiliates for Product sales, less: (i) reasonable and customary cash discounts consistent with the Seller’s past practices, (ii) customary rebates and Chargebacks, consistent with the Seller’s past practices and (iii) sales credits, refunds, returns and allowances accrued by Purchaser in accordance with GAAP. Such amounts shall be determined from books and records maintained by Purchaser in accordance with GAAP, consistently applied. To the extent that any accrual contemplated by the foregoing clause (iii) is subsequently adjusted in accordance with GAAP, Purchaser shall notify Seller thereof in writing and the Earnout owing hereunder in respect of the Product Net Sales corresponding to such accrued amounts shall be adjusted accordingly and the next subsequent Earnout payment hereunder shall be increased or decreased accordingly.

“Product Patents” shall mean any and all Patent Rights that are Controlled by Seller and/or any of its Affiliates and that relate primarily to the Product and/or the Product Business, as identified on Schedule 1.1(c), and including, without limitation, the Genentech Patents and the Snitman Patents.

“Product Records” shall mean all files, documents, instruments, papers, books and records Controlled by Seller and/or any of its Affiliates, whether in electronic or tangible form, that relate primarily to the Product, the Product Business and/or the Product Intellectual Property, including, without limitation, any and all pricing lists, customer lists, vendor lists, financial data, research and development files, marketing materials, regulatory files, adverse event reports and files; equipment specifications; analytical specifications and validation reports; Product batch records; bills of material; packaging specifications; approved and rejected vendor lists and audits; Product complaints, clinical studies and all documentation relating thereto; all

documentation associated with the Product Intellectual Property; copies of all filings (and supporting documentation) with Governmental Authorities, including, but not limited to, any and all Product NDAs and BLAs; component and labeling purchasing specifications; packaging and quality control SOPs; stability data, records, charts, reports and applicable SOPs; quality assurance/control data, records, charts, reports, and applicable SOPs; budgets; pricing guidelines; ledgers; journals; Assumed Contracts; Promotional Materials; operating data and plans; sales data; target lists; file histories, file wrappers, correspondence, application documents, registration documents, search reports, documents concerning the prosecution history, enforcement or maintenance of rights, or restrictions on use, with respect to the Product Intellectual Property, whether or not required to be kept or maintained under any Law; but excluding (i) the Excluded Data and Materials and (ii) any items to the extent that any Applicable Law prohibits their transfer.

“Product Returns” shall mean returns of Product by customers.

“Product Trademarks” shall mean any and all Trademarks that are Controlled by Seller and/or any of its Affiliates and that relate solely to the Product and/or the Product Business, as identified on Schedule 1.1(c). “Product Trademarks” shall not include the Seller Marks.

“Product Trade Secrets” shall mean any and all Trade Secrets that are Controlled by Seller and/or any of its Affiliates and that relate primarily to the Product and/or the Product Business.

“Promotional Materials” shall mean any and all physician lists, customer lists, marketing studies, marketing plans and strategies, sales force training materials, market research materials, and all advertising, selling, and promotional materials and other similar information and data, including, without limitation, records of sales and cost data for the twelve (12) months ended April 30, 2012, and as of the day prior to the Closing Date, to the extent the foregoing relate primarily to the Product and/or the Product Business, and to the extent the foregoing are within the Seller’s or its Affiliates’ possession as of the Closing Date.

“Property Taxes” shall have the meaning set forth in Section 8.8(c).

“Purchased Assets” shall mean, collectively, the assets of Seller set forth below:

(i)

the Product;

(ii)

all Inventory identified on Schedule 1.1(a);

(iii)

the Assumed Contracts;

(iv)

the Regulatory Approvals identified on Schedule 1.1(b);

(v)

the Promotional Materials;

(vi)

the Product Records;

(vii)

the Product Intellectual Property;

(viii)

the Product Master Cell Bank and Product Master Cell Bank Records, which are listed on Schedule 1.1(e); and

(ix)

all of Seller’s right, title and interest in and to each and all of the foregoing assets set forth in (i) – (viii), supra, including, without limitation, any and all of Seller’s and its Affiliates’ rights to bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property.

“Purchase Price” shall have the meaning set forth in Section 2.1(b).

“Purchaser” shall have the meaning set forth in the first paragraph of this Agreement.

“Purchaser Confidential Information” shall have the meaning set forth in Section 10.1(b).

“Purchaser Indemnified Parties” shall have the meaning set forth in Section 9.1(a).

“Purchaser Labeling” shall mean the printed labels, labeling and packaging materials, including printed carton, container labels and package inserts, to be prepared by Purchaser after the Closing Date and bearing Purchaser’s name for, or in connection with, packaging of the Product.

“Quality Agreement” shall mean the Quality Agreement executed by and between Seller and Boehringer-Ingelheim in connection with the execution of the B-I Supply Agreement, which Quality Agreement will be one of the Assumed Contracts to be assigned to Opco as part of the Purchased Assets.

“Regulatory Approvals” shall mean all applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, together with any and all supplements or modifications or amendments thereto, whether existing, pending, withdrawn or in draft form, prepared and submitted to any Governmental Authority in the Territory with respect to the Product, along with all supporting files, data, studies and reports relating thereto (in tangible and electronic form) and all technical and other information contained therein.

“Schedules” shall refer to the schedules to this Agreement which are hereby incorporated by reference into this Agreement.

“Seller” shall have the meaning set forth in the first paragraph of this Agreement.

“Seller Bank Account” shall have the meaning set forth in Section 2.1(b)(i).

“Seller Confidential Information” shall have the meaning set forth in Section 10.1(c).

“Seller Disclosure Schedule” shall have the meaning set forth in the first paragraph of Article III.

“Seller Indemnified Parties” shall have the meaning set forth in Section 9.1(b).

“Seller Marks” shall mean all Trademarks Controlled by Seller, other than the Product Trademarks, that are used in connection with the Product Business and the Assumed Liabilities as of the Agreement Date.

“Seller SEC Filing” shall have the meaning set forth in Section 3.13(a).

“Snitman Patents” shall mean United States Patent No. 6,936,695, United States Patent No. 6,936,694 (now reissued as US RE39,821E), Canadian Patent No. 1,341,561, and any and all Patent Rights related to the foregoing.

“Straddle Period” shall have the meaning set forth in Section 8.8(c).

“Taxes” shall mean all federal, state, local, foreign and other income, net income, gross income, gross receipts, sales, use, ad valorem, transfer, capital stock, franchise, profits, license, service, add on or alternative minimum tax, occupancy, withholding, payroll, fringe benefits, employment, employees’ income withholding, foreign or domestic withholding, unemployment, disability, excise, severance, stamp, value added, occupation, premium, property (including, real property and personal property taxes and any assessments, special or otherwise), environmental, windfall profits, customs, duties or other taxes, and any fees, assessments, levies, tariffs or charges of any kind that are in the nature of a tax, together with any interest and any penalties, additions to tax or additional amounts with respect thereto (and “Tax” means any one of the foregoing Taxes).

“Tax Return” shall mean any return, declaration, report or statement required to be filed with a Governmental Authority in respect to any Tax (including any attachments thereto, and any amendment thereof), including any information return, claim for refund, amended return or declaration of estimated Tax.

“Territory” shall mean the United States, Canada and Japan.

“Third Party” shall mean any Person other than Purchaser, Parent, Opco or Seller, or an Affiliate of any of them.

“Third Party Claim” shall mean any Proceeding at law or suit in equity by or against a Third Party as to which indemnification will be sought hereunder.

“Trademarks” shall mean any and all U.S., international or foreign trademarks, service marks, trade names, service names, brand names, product names, trade dress, trade styles, logos, symbols, and other product or service source identifiers and general intangibles of a like nature, together with all goodwill associated with any of the foregoing, along with all applications, registrations, renewals and extensions therefor.

“Trade Secrets” shall mean information, including, without limitation, any formula, program, device, method, technique, and/or process, that: (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, any Third Party who can obtain economic value from its disclosure or use, and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

“Transaction Documents” shall mean this Agreement and the Ancillary Agreements.

“Transfer Taxes” shall have the meaning set forth in Section 8.8(b).

“Transition Services Agreement” shall mean that certain transition services agreement in the form attached hereto as Exhibit C.

“Treasury Regulations” shall mean the income tax regulations issued under the Code.

Section 1.2 Construction.

(a) The words “hereof,” “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement.

(b) The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. References to Articles, Sections, Exhibits, and Schedules are to Articles, Sections, Exhibits, and Schedules of this Agreement unless otherwise specified.

(c) All Exhibits and Schedules annexed hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth in full herein. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein, shall have the meaning as defined in this Agreement.

(d) Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular, and words denoting either gender shall include both genders as the context requires. Where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning.

(e) Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation,” whether or not they are in fact followed by those words or words of like import.

(f) The use of the word “or” shall not be exclusive.

(g) A reference to any legislation or to any provision of any legislation shall include any modification, amendment, re-enactment thereof, any legislative provision substituted therefore and all rules, regulations and statutory instruments issued or related to such legislation.

(h) Any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement. No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement. No parol evidence shall be introduced in the construction or interpretation of this Agreement unless the ambiguity or uncertainty in issue is plainly discernable from a reading of this Agreement without consideration of any extrinsic evidence.

(i) The Parties agree that any exception or qualification set forth in the Seller Disclosure Schedule with respect to a particular representation or warranty contained herein shall be deemed to be an exception or qualification with respect to other representations and warranties contained in this Agreement to the extent the applicability of the disclosure to each other representation and warranty is reasonably apparent from the text of the disclosure made. Nothing in the Seller Disclosure Schedule is intended to broaden the scope of any representation, warranty or covenant of Seller contained in this Agreement.

ARTICLE II

THE TRANSACTION

Section 2.1 Purchase and Sale of Purchased Assets.

(a) Upon the terms and subject to the conditions set forth in this Agreement, at the Closing, Seller shall sell, assign, transfer, convey and deliver to Purchaser, and Purchaser shall purchase, acquire and accept, all of Seller’s right, title and interest in and to the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances; provided that Opco shall purchase, acquire and accept the Inventory, B-I Supply Agreement and Quality Agreement in lieu of Purchaser.

(b) As consideration for the transactions contemplated hereby (the “Purchase Price”), Purchaser shall make the following payments to Seller:

(i)

Closing Cash Payment. At Closing, Purchaser shall make a cash payment of Fifty Five Million Dollars ($55,000,000) (the “Closing Cash Payment”) by wire transfer of immediately available funds to a bank account in the United States identified by Seller to Purchaser in writing at least two (2) Business Days prior to the Closing Date (the “Seller Bank Account”).

(ii)

Additional Consideration.

A. Earnout. On each of the one (1) year and two (2) year anniversaries of the Closing, Purchaser shall pay to Seller a cash payment (each an “Earnout” and together, the “Earnouts”) by wire transfer of immediately available funds to the Seller Bank Account or, if applicable, to an alternate bank account in the United States identified by Seller to Purchaser in writing (the “Alternate Seller Bank Account”), within forty-five (45) days following the end of each Annual Period, such amount as calculated pursuant to the formulas set forth below:

•

12.5% of total Product Net Sales from $0 - $10,000,000; and

•

7.5% of total Product Net Sales from $10,000,001 - $20,000,000.

Product Net Sales shall be calculated on an Annual Period basis and payments of the foregoing Earnouts will be paid within forty-five (45) days after the end of each three (3) month period within each of the first and second Annual Periods.

(iii)

Assumed Liabilities. At the Closing, Purchaser shall assume from Seller, and thereafter pay, perform and discharge when due, the Assumed Liabilities.

(c) The B-I Purchase Orders shall constitute Assumed Contracts, provided, however, Seller shall, at Seller’s expense, pay, perform and discharge on Purchaser’s behalf when due the amounts payable to Boehringer-Ingelheim under the B-I Purchase Orders. If Closing occurs prior to the transfer of title from Boehringer-Ingelheim to Seller of Product under the B-I Purchase Orders, the Parties acknowledge and agree that Purchaser may directly instruct Boehringer-Ingelheim to ship or have shipped the Product under the B-I Purchase Orders to Opco pursuant to the terms of the B-I Supply Agreement. If Closing occurs after the transfer of title from Boehringer- Ingelheim to Seller of Product under the B-I Purchase Orders, Purchaser acknowledges and agrees that such Product shall remain at the United States facilities maintained by CORD Logistics, Inc. where CORD Logistics, Inc. shall continue to store and process the Product under the Distribution Services Agreement between CORD Logistics, Inc. and InterMune Pharmaceuticals Inc., dated January 15, 1999, as amended from time to time, but title to such Product shall be transferred to Opco, without further consideration, at the time of Closing as part of the Purchased Assets.

Section 2.2 Excluded Assets. The Parties acknowledge and agree that Seller is not selling, conveying, transferring, assigning, or delivering, or assigning any rights whatsoever to the Excluded Assets to Purchaser, and Purchaser is not purchasing, taking delivery of or acquiring any rights whatsoever to the Excluded Assets from Seller.

Section 2.3 Assumed Liabilities. Upon the terms and subject to the conditions set forth in this Agreement, at the Closing, Purchaser shall assume and agree to pay, perform or otherwise discharge, in accordance with their respective terms and subject to the respective conditions thereof, only the following Liabilities (collectively, the “Assumed Liabilities”); provided that Opco shall assume any such Liability in lieu of Purchaser with respect to the Inventory, B-I Supply Agreement and Quality Agreement:

(a) Any Liability arising on or after the Closing under any Assumed Contract (other than any Liability arising out of or relating to a breach of such Assumed Contract which occurred prior to the Closing);

(b) Any Liability arising out of the conduct of the Product Business by Purchaser after the Closing, including any Liabilities and obligations arising out of or resulting from product liability claims for the Product but only with respect to Product which is sold by Purchaser after the Closing;

(c) Any Liability arising after the Closing for Taxes imposed with respect to the Product Business or the Purchased Assets that are attributable to the ownership, sale, operation or use of the Product Business or the Purchased Assets following the Closing Date;

(d) Property Taxes and Transfer Taxes to the extent specifically allocated to Purchaser pursuant to Section 8.8; and

(e) Any other Liability specifically set forth on Schedule 2.3(e) hereto.

(f) For the avoidance of doubt, the Parties acknowledge that in no event shall the provisions of this Section 2.3 be construed to limit Purchaser’s, Parent’s or Opco’s obligations under Article IX.

Section 2.4 Excluded Liabilities.

(a) The Parties hereby acknowledge and agree that, other than the Assumed Liabilities, or as otherwise specifically provided in the Transaction Documents, Purchaser shall not be responsible for, assume, or be obligated to pay, perform or otherwise discharge any Liabilities or obligations of Seller, whether or not related to the Product Business (collectively, the “Excluded Liabilities”), which Excluded Liabilities shall include, but not be limited to, (i) any obligation or Liability of Seller created as a result of this Agreement, (ii) any Liability relating to Product sold prior to the Closing Date, or the operation of the Product Business prior to the Closing Date, (iii) those items set forth on Schedule 2.4(a), and (iv) all liabilities with respect to any Taxes owed by Seller, including any liability of Seller for the Taxes of any other Person under Treasury Regulation Section 1.1502-6 (or any similar provision of state, local or foreign law), as a transferee, or as a result of a Tax sharing of similar agreement, and Taxes otherwise imposed with respect to the Product Business or the Purchased Assets that are attributable to the ownership, sale, operation or use of the Product Business or the Purchased Assets on or prior to the Closing Date. For the avoidance of doubt, the Parties acknowledge that in no event shall the provisions of this Section 2.4 be construed to limit Seller’s obligations under Article IX.

(b) The Parties hereby acknowledge and agree that, other than as provided in the Transaction Documents, Seller shall not be responsible for, assume, or be obligated to pay, perform or otherwise discharge any obligations or liabilities of Purchaser. The Parties acknowledge that in no event shall the foregoing sentence be construed to limit Seller’s obligations under Article IX.

Section 2.5 Closing Date. Unless this Agreement shall have been terminated pursuant to Article VII, the consummation of the transactions contemplated by Section 2.1 (the “Closing”) shall take place at the offices of Latham & Watkins LLP, 140 Scott Drive, Menlo Park, CA 94025 at 10:00 a.m., PDT, and in such other places as are necessary to effect the transactions to be consummated at the Closing, on the fifth (5th) Business Day immediately following the satisfaction or, to the extent permitted, waiver of all of the conditions in Article VII (other than those conditions which by their nature are to be satisfied or, to the extent permitted, waived at the Closing but subject to the satisfaction or, to the extent permitted, waiver of such conditions), or at such other time, date and place as shall be determined by mutual agreement of the Parties (such date of the Closing being herein referred to as the “Closing Date”). The Closing shall be deemed to have become effective as of 12:01 a.m., PDT on the Closing Date.

Section 2.6 Purchaser Obligations. At the Closing, Purchaser shall (i) deliver to Seller the Closing Cash Payment and (ii) execute and deliver to Seller the following:

(a) the Bills of Sale;

(b) the Assignment and Assumption Agreements;

(d) the Patent Assignment Agreement;

(e) the certificate required by Section 7.3(a);

(f) the Domain Name Assignment Agreement;

(g) its acknowledgment to and acceptance of the waiver and consent of Boehringer-Ingelheim, as described in Section 7.2(e) hereof; and

(h) such other documents and instruments as Seller may reasonably request to consummate the transactions described in Section 2.1.

Section 2.7 Seller Obligations. At the Closing, Seller shall execute and deliver to Purchaser, the following:

(a) the Bills of Sale;

(b) the Assignment and Assumption Agreements;

(d) the Patent Assignment Agreement;

(e) the Domain Name Assignment Agreement;

(f) the B-I Supply Agreement, Quality Agreement and waiver and consent of Boehringer-Ingelheim, as described in Section 7.2(e) hereof;

(g) a confirmation receipt reflecting receipt of the Closing Cash Payment;

(h) a certificate from Seller under Treasury Regulations Section 1.1445-2 certifying Seller’s non-foreign status;

(i) the certificate required by Section 7.2(a); and

(j) such other documents and instruments as Purchaser may reasonably request to consummate the transactions described in Section 2.1.

Section 2.8 Allocation of Purchase Price. Seller and Purchaser shall allocate the Purchase Price (and Assumed Liabilities, to the extent properly taken into account under the Code) among the Purchased Assets for tax purposes in accordance with Section 1060 of the Code. A draft allocation schedule shall be prepared by Purchaser and delivered to Seller not later than thirty (30) days after the Closing Date for Seller’s review and comment. Seller and Purchaser shall work in good faith to resolve any disputes relating to the draft allocation schedule (such allocation schedule as finally agreed to by Purchaser and Seller, the “Allocation Schedule”). The Allocation Schedule shall be revised as mutually agreed by Purchaser and Seller to reflect any adjustment to the Purchase Price pursuant to the provisions of this

Agreement. Purchaser and Seller shall file all Tax Returns (including, but not limited to, a Form 8594 (Asset Acquisition Statement under Section 1060 of the Code)) with respect to the transactions contemplated by this Agreement consistently with the Allocation Schedule and any adjustments thereto, unless otherwise required by Applicable Law.

Section 2.9 Assignability and Consents. Notwithstanding anything to the contrary contained in this Agreement, but subject to Section 7.2, if the sale, assignment, transfer, conveyance or delivery or attempted sale, assignment, transfer, conveyance or delivery to Purchaser of any Purchased Assets (i) is prohibited by any Applicable Law or (ii) would require any consents, waivers, approvals or authorizations of a Third Party or Governmental Authority (a “Consent”) and such Consents shall not have been obtained prior to the Closing and an attempted assignment thereof without such Consent would constitute a breach thereof, then in either case, the Closing will proceed without the sale, assignment, transfer, conveyance or delivery of such Purchased Assets and this Agreement shall not constitute an agreement for the sale, assignment, transfer, conveyance or delivery of such Purchased Asset. In the event that the Closing proceeds without the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset, then following the Closing, the Parties shall use their commercially reasonable efforts, and cooperate with each other, to obtain promptly such Consents; provided, however, that Purchaser shall not be required to pay any consideration to obtain any such Consent. Pending receipt of such Consents, the Parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide to Purchaser the benefits of and the obligations associated with use of such Purchased Asset that it would have obtained or been subject to had the asset been conveyed to Purchaser at the Closing. To the extent that Purchaser is provided the benefits pursuant to this Section 2.9 of any Assumed Contract, Purchaser shall (x) perform for the benefit of the other parties thereto the obligations of Seller or any Affiliate of Seller thereunder, which arise after the Closing, and (y) shall satisfy any related Liabilities with respect to such Assumed Contract that, but for the lack of a Consent to assign such obligations or Liabilities to Purchaser, would be Assumed Liabilities. Once Consent for the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset not sold, assigned, transferred, conveyed or delivered at the Closing is obtained or given, Seller shall promptly assign, transfer, convey and deliver such Purchased Asset to Purchaser at no additional cost to Purchaser.

Section 2.10 License Grant. Seller hereby grants Purchaser, on Seller’s behalf and on behalf of any applicable Affiliate, a non-exclusive, royalty-free, sublicenseable license, under Know-How Controlled by Seller, to use the IPF Patient Data solely for the treatment and support of patients using the Product; provided that, for the avoidance of doubt, Purchaser shall not use any of the IPF Patient Data to seek regulatory approval of or to commercialize the Product for the treatment of idiopathic pulmonary fibrosis.

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF SELLER

Seller represents and warrants to Purchaser as of the date hereof, but subject to such exceptions as are specifically disclosed in the disclosure schedule referencing the appropriate Sections hereof (unless the applicability and relevance of the disclosure to another representation or warranty is readily apparent on the face of such disclosure, in which case such disclosure shall also apply to such other representations or warranty) supplied by Seller and dated as of the date hereof (the “Seller Disclosure Schedule”), as follows:

Section 3.1 Organization and Authority. Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Seller has all necessary corporate power and corporate authority, and has taken all actions necessary, to execute and deliver the Transaction Documents, and the transactions contemplated thereby, and effect the transactions contemplated thereby and has duly authorized the execution, delivery and performance of the Transaction Documents and transactions or documents contemplated thereby by all necessary corporate action. Seller has all corporate power and corporate authority necessary to own its assets and carry on the Product Business as currently being conducted by Seller. The Transaction Documents will be upon the Closing, the valid and legally binding obligations of Seller, enforceable against it in accordance with their terms, subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

Section 3.2 Purchased Assets; Title to Purchased Assets.

(a) Except as set forth on Section 3.2 of the Seller Disclosure Schedule, the Purchased Assets collectively constitute all of the properties, rights, titles, interests and other tangible and intangible assets owned by Seller and/or any of its Affiliates and used by Seller and/or any of its Affiliates to conduct the Product Business consistent with past practice.

(b) Seller has good and marketable title to the Purchased Assets owned by Seller free and clear of any Encumbrances, except for the Permitted Encumbrances. Seller has not received any notice of any adverse claims of ownership to the Purchased Assets owned by Seller, and to Seller’s Knowledge, no facts or circumstances exist which would provide a reasonable basis for any such adverse claim of ownership of any of the Purchased Assets owned by Seller. Upon delivery to Purchaser at the Closing of the Bills of Sale, Domain Name Assignment Agreement, Patent Assignment Agreement, and the Assignment and Assumption Agreements, Seller will thereby sell, transfer, convey and assign to Purchaser good and marketable title to the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances, subject to the terms and conditions of this Agreement.

Section 3.3 Consents; Non-Contravention.

(a) Except for the requisite filings under the HSR Act, if any, and the expiration or termination of the waiting period thereunder, and except for all filings and other actions contemplated by the Transaction Documents (including the necessary transfer of filings, notices and approvals required to transfer the Regulatory Approvals from Seller to Purchaser), the execution, delivery and performance by Seller of the Transaction Documents and the consummation by Seller of the transactions contemplated thereby will not require any notice to, filing with, or the consent, approval or authorization of, any Person or Governmental Authority.

(b) Except as set forth on Section 3.7 of the Seller Disclosure Schedule, neither the execution and delivery of the Transaction Documents nor the consummation of the transactions

contemplated thereby will (i) violate or result in a breach or result in the acceleration or termination of, or the creation in any Third Party of the right to accelerate, terminate, modify or cancel, any Assumed Contract, (ii) conflict with, violate or result in a breach of any provision of the certificate of incorporation, or by-laws of Seller, (iii) conflict with or violate in any material respect Applicable Law, or (iv) conflict with, violate or result in a breach of any material agreement, instrument or arrangement to which Seller is subject, including any agreement affecting Seller’s ownership of, or ability to assign, the Product Intellectual Property.

Section 3.4 Regulatory Approvals.

(a) Section 3.4(a) of the Seller Disclosure Schedule sets forth a complete and correct list of all Regulatory Approvals. Seller has provided to Purchaser complete and correct copies of the Regulatory Approvals or Purchaser has had access to such copies of the Regulatory Approvals.

(b) Seller is in material compliance with all of the Regulatory Approvals listed on Section 3.4(a) of the Seller Disclosure Schedule, and, since the time Seller acquired its rights in the Product, Seller has not received any notification or other communication, written or oral, from any Third Party with respect to any alleged or possible violation with respect to any such Regulatory Approvals, and to Seller’s Knowledge, there are no facts or circumstances that would form a reasonable basis for any such violation.

(c) The Regulatory Approvals are in full force and effect and have been duly and validly issued. The U.S. Regulatory Approval is in good standing, has not been revoked, rescinded, amended or modified, and, to Seller’s Knowledge, no event has occurred or notification or other communication been received by Seller from the FDA or other Governmental Authority, a notified body or any other party that would materially adversely affect or otherwise jeopardize the FDA approval status of the Product. To the Knowledge of Seller, no applications made or other materials submitted by Seller to the FDA or other Governmental Authority or a notified body with respect to the Product contained an untrue statement of material fact when submitted, or omitted to state a material fact when submitted which was required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading.

(d) The Regulatory Approval files of Seller have been maintained in accordance with reasonable industry standards. Seller has in its possession or control, or has access to, copies of all the material documentation filed in connection with filings made by Seller for Regulatory Approval of the Product, including the complete regulatory chronology for each Regulatory Approval (if applicable) and Seller will, to the extent any such materials are not delivered pursuant to the terms of this Agreement, upon request of Purchaser make such materials available for review and copying by Purchaser and its representatives.

Section 3.5 Compliance with Laws and Litigation.

(a) Except with respect to any matter relating to or arising from Regulatory Approvals (which is addressed in Section 3.4), with respect to the Product, the Product Business, the Purchased Assets and the Assumed Liabilities, Seller is in material compliance with all Applicable Laws.

(b) Except with respect to routine administrative proceedings conducted with respect to Regulatory Approvals conducted in the Seller’s ordinary and usual course of conduct of the Product Business, there are no Proceedings, including any action or investigation by the U.S. Department of Justice, Office of the Inspector General, or any Governmental Authority, existing, pending, or to the Knowledge of Seller, threatened against or affecting Seller, with respect to the Product, the Product Business, the Purchased Assets or the Assumed Liabilities or with respect to this Agreement or the transactions contemplated hereby, and there are no Proceedings pending in which Seller is the plaintiff or claimant and which relate to the conduct of Seller with respect to the Purchased Assets or the Product Business prior to the Closing Date. Seller is not subject to any Proceedings, nor, to the Knowledge of Seller, are any Proceedings threatened, which, in any such case, that would reasonably be expected to impair or delay its ability to perform its obligations under this Agreement.

Section 3.6 No Material Adverse Change.

(a) Except as set forth on Section 3.6 of the Seller Disclosure Schedule, since January 1, 2010, there has been no Material Adverse Effect on the Product Business or the Purchased Assets; (b) there has been no damage or impairment to, or destruction or loss of, the Purchased Assets, that had or would reasonably be expected to have a Material Adverse Effect on the Product Business or the Purchased Assets; (c) there has been no sale, assignment, transfer or Encumbrance of the Purchased Assets outside the ordinary course of business; and (d) there has been no change in the contingent obligations of Seller by way of guaranty, endorsement, indemnity, warranty or otherwise that would reasonably be expected to have a Material Adverse Effect.

(b) Since January 1, 2010, Seller has, consistent with the conduct of the Product Business during the twenty-four (24) months prior to the Agreement Date: (i) continued and conducted the Product Business in Seller’s ordinary and usual course of business, and (ii) maintained its relationships with suppliers, distributors, customers and others having material business relationships with Seller related to the Product Business.

Section 3.7 Assumed Contracts.

(a) Section 3.7 of the Seller Disclosure Schedule sets forth a complete and correct list of each of the Assumed Contracts. Except as set forth in Section 3.7 of the Seller Disclosure Schedule, the Assumed Contracts constitute all of the contracts to which Seller or any of its Affiliates is a party or is otherwise bound and that are material to or otherwise relate solely or primarily to the Purchased Assets and/or the Product Business. Seller has delivered to or made available to Purchaser true and complete copies of all such Assumed Contracts and any other contracts or agreements identified on Schedule 1.1(d). All such Assumed Contracts are, as to Seller (and, as to the other parties thereto, to the Knowledge of Seller), legal, valid and binding agreements in full force and effect and enforceable in accordance with their respective terms (subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to

general equitable principles (regardless of whether in equity or at law)) and, subject to Section 2.9, may be transferred to the Purchaser pursuant to this Agreement and, as of the Closing Date and subject to the provisions of each such Assumed Contract, will continue in full force and effect in each case without the consent, approval, or act, or the making of any filing with, any other party thereto.

(b) Seller is not in material breach or default, and no event has occurred that with notice or lapse of time would constitute a material breach or default by Seller permitting termination, modification, or acceleration, under any Assumed Contract of the Seller Disclosure Schedule. To the Knowledge of Seller, no other party to any Assumed Contract is in material breach or default under, or has repudiated any material provision of, any Assumed Contract, and no event has occurred and no condition or state or facts currently exists which, with time or the giving of notice, or both, would constitute such a material default or breach by such other party.

Section 3.8 Inventory and Returns.

(a) Section 3.8(a) of the Seller Disclosure Schedule sets forth a complete and correct list of the Inventory as of May 15, 2012, as the same will be revised as of the day prior to the Closing Date. The Inventory has been produced or manufactured in accordance with all Applicable Law and Regulatory Approvals.

(b) Since January 1, 2010, Seller has not (i) materially altered its distribution practices or terms with respect to the Product, or (ii) materially altered its activities and practices with respect to inventory levels of the Product maintained at the wholesale, chain, institutional or retail levels in any material respect.

(c) Section 3.8(c) of the Seller Disclosure Schedule sets forth, on a monthly basis, the returns of the Product for the one year period ended May 15, 2012, as the same will be revised as of the day prior to the Closing Date.

(d) All Inventory included in the Purchased Assets shall be fully paid for, saleable and in good and marketable condition and shall be in compliance with all Laws applicable to its manufacture, labeling and storage.

(e) All Inventory identified on Schedule 1.1(a) shall be provided to Opco without additional consideration.

Section 3.9 Tax Matters.

(a) There are no Encumbrances for Taxes on any of the Purchased Assets other than Permitted Encumbrances (within the meaning of clause (i) of such definition).

(b) Seller has timely filed all Tax Returns that were required to be filed relating to the Product Business or the Purchased Assets and has paid all Taxes shown thereon as owing, except where the failure to file Tax Returns or to pay Taxes would not have a Material Adverse Effect.

(c) Except as disclosed on Schedule 3.9(c), there are pending or ongoing against Seller no federal, state, local or foreign audits, suits, proceedings, claims or administrative

proceedings or, to the Knowledge of Seller, investigations, for Taxes of Seller relating to the Product Business or the Purchased Assets or any Tax Returns of Seller relating to the Product Business or the Purchased Assets that could result in (i) a material Encumbrance on the Purchased Assets or (ii) material Taxes for which the Purchaser Indemnified Parties may be liable.

(d) Seller has not received any written ruling concerning Taxes of Seller with respect to the Product Business or the Purchased Assets from any taxing authority.

(e) Except as disclosed on Schedule 3.9(e), during the three (3) year period ending on the date of this Agreement, no jurisdiction where Seller does not file a Tax Return has made a claim in writing that Seller is required to file a Tax Return relating to the Product Business or the Purchased Assets for such jurisdiction or that any Taxes relating to the Product Business of the Purchased Assets are due as a result of doing any business in such jurisdiction.

Section 3.10 Intellectual Property.

(a) Seller is the owner or licensee of all right, title and interest in and to, or otherwise has the right to use, the Product Intellectual Property, free and clear of any Encumbrance, except for the Permitted Encumbrances; Seller has the full and unrestricted right, power and authority to grant, convey, transfer and assign to Purchaser all of Seller’s (and any of its Affiliates’) right, title and interest in and to the Product Intellectual Property; and Seller’s grant, conveyance, transfer and assignment to Purchaser of all of Seller’s (and any of its Affiliates’) right, title and interest in and to the Product Intellectual Property will not violate or breach any Assumed Contract.

(b) Schedule 1.1(c) sets forth a true and complete list of all Product Intellectual Property, and Schedule 1.1(d) sets forth a true and complete list of all Assumed Contracts through which the Seller (and any of its Affiliates) has obtained rights to any Product Intellectual Property.

(c) None of the Product Patents is involved in any Proceeding (including, but not limited to, any Proceeding challenging the ownership, right to use, validity, enforceability, and/or any allegation of infringement, of any of the Product Patents (and whether under the Hatch Waxman Act, the Biologics Price Competition and Innovation Act, or other applicable Law)). To the Knowledge of Seller, no inequitable conduct (i.e., any conduct that would be in violation of 37 C.F.R. §1.56, or its foreign equivalent, if applicable) was committed in the prosecution of any of the Product Patents owned by Seller.

(d) Except as set forth in Section 3.10 of the Seller Disclosure Schedule, to the Knowledge of Seller, none of the Product Trademarks, Product Copyrights or Product Domains is involved in any Proceeding.

(e) To the Knowledge of Seller, all maintenance fees, annuity fees or renewal fee payments have been timely paid, as and if applicable, for each of the Product Patents, Product Trademarks, Product Copyrights and Product Domain Names owned by the Seller.

(f) There are no pending or, to the Knowledge of Seller, threatened Proceedings (i) based upon, challenging, or seeking to deny or restrict, the Seller’s (or, as applicable, any of its Affiliates’) use of any of the Product Intellectual Property, and/or (ii) alleging that the manufacture, use, sale, offer for sale, import, or export of the Product by Seller (or, as applicable, by any of its Affiliates), or the operation of the Product Business, infringes the rights of any Third Party in and to any Intellectual Property.

(g) To the Knowledge of Seller, no Third Party is engaging in any activity that infringes or misappropriates the Product Intellectual Property. Neither Seller nor its Affiliates has received any notice from any Third Party, under either the Hatch Waxman Act or the Biologics Price Competition and Innovation Act, asserting any position of non-infringement, invalidity or unenforceability of any of the Product Patents.

(h) Seller has taken all action reasonable and commensurate with industry best practices: (i) to protect, preserve and maintain the secrecy, confidentiality and value of the Product Trade Secrets and the Product Know-How, and thus, to the Knowledge of Seller, the Product Trade Secrets and/or Product Know-How are not part of the public knowledge or literature, and have not been used, divulged or appropriated either for the benefit of any Third Party or to the detriment of Seller; and (ii) to vest in Seller all right, title, and interest in and to any and all Product Intellectual Property conceived, created or developed by all former and current employees and contractors of Seller or its Affiliates, and thus, to the Knowledge of Seller, no former or current employees and/or contractors of Seller or its Affiliates own, hold or possess, in their individual or any other capacities, any right, title or interest in and to any of the Product Intellectual Property. Any executed agreements obtained by Seller in connection with Seller’s actions under Sections 3.10(h)(i) and (ii), shall be retained by Seller for a period of ten (10) years following the Closing Date, unless Seller gives Purchaser notice of its intention to destroy any such executed agreements and affords Purchaser a reasonable opportunity to take possession or make copies thereof.

(i) Neither Seller nor any of its Affiliates has licensed, granted, conveyed, transferred or assigned to any Third Party any right, title or interest in and to the Product, any of the Product Intellectual Property and/or the Product Business.

Section 3.11 Product Records. All Product Records have been made available by Seller to Purchaser for examination and copying, and all Product Records are complete and correct in all material respects and have been maintained in accordance with reasonable industry standards.

Section 3.12 Brokers, Finders, etc. Other than Locust Walk Partners, whose fees, commission and expenses are the sole responsibility of Seller, Seller has not employed any broker, finder, consultant or other intermediary in connection with the transactions contemplated by the Transaction Documents who would have a valid claim for a fee or commission from Purchaser in connection with such transactions by reason of any action taken by or on behalf of Seller.

Section 3.13 Financial Statements.

(a) Each form, report, schedule and document required to be filed by Seller under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2010 (collectively, the “Seller SEC Filings” and individually, a “Seller SEC Filing”), solely with respect to the Product Business, (i) did, as of its date, comply in all material respects with the requirements of the Exchange Act and (ii) did not, at the time it was filed, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.

(b) Each of the consolidated financial statements (including in each case, any notes thereto) contained in any Seller SEC Filing, solely to the extent each relates to the Product Business, (i) was prepared in accordance with GAAP applied (except as may be indicated in the notes thereto and, in the case of unaudited quarterly financial statements, as permitted by Form 10-Q under the Exchange Act) on a consistent basis throughout the periods indicated, and (ii) presented fairly the consolidated financial position, results of operations and cash flows of Seller as of the respective dates thereof and for the respective periods indicated therein (subject, in the case of unaudited statements, to normal and recurring year-end adjustments which did not result in a Material Adverse Effect).

(c) Seller has previously furnished to Purchaser or has identified to Purchaser and provided Purchaser an opportunity to confirm or review, (i) (A) sales of the Product for the three-year period ended December 31, 2011, (B) representative returns and allowances pertaining to the Product for the three-year period ended December 31, 2011, (C) gross and net sales data and cost of goods to Seller for the three-year period ended December 31, 2011 (collectively, the “Financial Data”). The summary of the Financial Data delivered to Purchaser under the file named PASO Finance Template (Q1 2012).xlsx, a copy of which is attached as Section 3.13(c) of the Seller Disclosure Schedule, was prepared by Seller in good faith from the Product Records, and fairly present, in all material respects, the financial condition and results of operations of the Product Business as of the date thereof and for the periods shown. To the Knowledge of Seller, the Financial Data furnished by Seller to Purchaser does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the facts disclosed therein not materially misleading in light of the circumstances in which disclosed.

Section 3.14 Insurance. There are no material claims currently made against any of the insurance policies of Seller relating to the Product, the Product Business, no material impairment of the amounts of coverage required thereunder, and Seller has no Knowledge of any reasonable basis for any such claims.

Section 3.15 Regulatory Compliance. To the extent applicable to the Product in the Territory:

(a) To the Knowledge of Seller, the Product has been developed, labeled, stored, tested and distributed in compliance with all applicable requirements under the Federal Food Drug and Cosmetic Act 21 U.S.C. §§301 et. seq., its implementing regulations, and all similar Applicable Laws, including those relating to investigational use, premarket clearance and

applications or abbreviated applications to market a new product, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(b) To the Knowledge of Seller, all pre-clinical and clinical investigations conducted by or on behalf of Seller with respect to the Product have been, and are being, conducted in compliance with all applicable recommendations, policy, and guidance issued by the FDA, 21 C.F.R. Parts 50, 54, 56, 58 and 312 and all other Applicable Laws, including those with respect to good laboratory practices, investigational new drug requirements, good clinical practice requirements (including informed consent and institutional review boards designed to ensure the protection of the rights and welfare of human subjects), and federal and state laws restricting the use and disclosure of protected health information, including but not limited to Health Information Technology for Economic and Clinical Health (“HITECH”), the Health Institute Portability and Accountability Act (“HIPAA”), and regulations related to HITECH and HIPAA, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(c) To the Knowledge of Seller, with respect to the Product (i) all manufacturing operations conducted for the benefit of Seller have been and are being conducted in compliance with the FDA’s current Good Manufacturing Practice regulations for drug products, including 21 C.F.R. Parts 210 and 211, and all similar Applicable Laws, except for noncompliance which, individually or in the aggregate, would not have, or be reasonably likely to have, a Material Adverse Effect; and (ii) Seller is in compliance with all registration and listing requirements set forth in 21 U.S.C. §360 and 21 C.F.R. Part 207, and all similar Applicable Laws, except for noncompliance which individually or in the aggregate would not reasonably be expected to have a Material Adverse Effect.

(d) Since the date of acquisition of the Product (or rights thereto) by Seller, the Product has not been recalled, suspended or discontinued as a result of any action by the FDA or any other foreign Governmental Authority within the Territory, by Seller or by any licensee, distributor or marketer of the Product, within the Territory, or, to the Knowledge of Seller, outside of the Territory.

(e) Seller has not received any notice or other communication from the FDA or any other Governmental Authority alleging any violation of any Law applicable to any activity relating to the Product Business that is subject to the jurisdiction of FDA or any other Governmental Authority, nor has any Governmental Authority commenced, or threatened to initiate, any action to enjoin or place restrictions on the production of the Product.

(f) To the Knowledge of Seller, there are no facts, circumstances or conditions that would be sufficient to presently, or solely with the passage of time in the ordinary course of business, provide a reasonable basis for a recall, suspension or discontinuance of the Product.

(g) Seller is in compliance with 21 U.S.C. §355, 42 U.S.C. §262 and applicable FDA implementing regulations, including 21 C.F.R. Parts 312, 314, 600 and 601 and all similar Applicable Laws, and all terms and conditions of the applicable new drug application, biologic license application and investigational new drug exemption submission under 21 U.S.C. §355(i),

except for any such failure or failures to be in compliance which individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. As to the Product, Seller and its officers, employees or agents have included in each applicable application, where required, the certification described in 21 U.S.C. §335a(k)(l) and each such certification was true, complete and correct in all material respects when made.

(h) With respect of the Product or of the Product Business, Seller has not committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any similar policy. Neither the Seller nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct with respect to the Product Business for which debarment is mandated by 21 U.S.C. §335a(a) or any similar Law or authorized by 21 U.S.C. §335a(b) or any similar Law.

(i) Seller has delivered to Purchaser or made available to Purchaser copies of all annual safety update reports prepared by Seller with respect to the Product.

Section 3.16 No Other Warranties. Except as expressly provided in the Transaction Documents, Seller does not make any representation or warranty about the Product, the Purchased Assets the Assumed Liabilities or the Product Business, whatsoever. WITHOUT LIMITING THE FOREGOING, PURCHASER ACKNOWLEDGES THAT, EXCEPT AS EXPRESSLY PROVIDED IN THE TRANSACTION DOCUMENTS, (A) THE PURCHASED ASSETS ARE BEING TRANSFERRED “AS IS,” (B) SELLER MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND OR AS BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND (C) SELLER SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY, WARRANT OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF NONINFRINGEMENT.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF PURCHASER

Purchaser, Parent and Opco, jointly and severally, hereby represent and warrant to Seller as follows.

Section 4.1 Organization and Authority. Purchaser is a company incorporated under the laws of Ireland. Parent is a limited liability company duly organized, validly existing and in good standing under the laws of Delaware. Opco is a company incorporated under the laws of Ireland. Each of Purchaser, Parent and Opco has all requisite corporate or limited liability company, as applicable, power and authority to execute and deliver the Transaction Documents, and the transactions contemplated thereby, and effect the transactions contemplated thereby and has duly authorized the execution, delivery and performance of the Transaction Documents and transactions or documents contemplated thereby by all necessary corporate or limited liability company, as applicable, action. Each of Purchaser, Parent and Opco has all requisite corporate or limited liability company, as applicable, power and authority necessary to carry on its business as is currently being conducted. The Transaction Documents will be upon

the Closing, the valid and legally binding obligations of each of Purchaser, Parent and Opco, enforceable against them in accordance with their terms, subject to applicable bankruptcy moratorium, reorganization, insolvency and similar laws of general application relating to or affecting the rights and remedies of creditors generally and to general equitable principles (regardless of whether in equity or at law).

Section 4.2 Consents; No Violations.

(a) Except for the requisite filings under the HSR Act, if any, and the expiration or termination of the waiting period thereunder, and except for all filings and other actions contemplated by the Transaction Documents (including the necessary transfer of filings, notices and approvals required to transfer the Regulatory Approvals from Seller to Purchaser), the execution, delivery and performance by each of Purchaser, Parent and Opco of the Transaction Documents and the consummation by Purchaser, Parent and Opco of the transactions contemplated thereby will not require any notice to, filing with, or the consent, approval or authorization of, any Person or Governmental Authority.

(b) Neither the execution and delivery of the Transaction Documents nor the consummation of the transactions contemplated thereby will (i) violate or result in a breach or result in the acceleration or termination of, or the creation in any Third Party of the right to accelerate, terminate, modify or cancel, any indenture, contract, lease, sublease, loan agreement, note or other obligation or liability to which Purchaser, Parent or Opco is a party or is bound, (ii) conflict with, violate or result in a breach of any provision of the organizational documents of Purchaser, Parent or Opco, or (iii) conflict with or violate in any material respect Applicable Law.

Section 4.3 Brokers, Finders, etc. Purchaser, Parent, Opco and their respective Affiliates have not employed any broker, finder, consultant or other intermediary in connection with the transactions contemplated by this Agreement and the Ancillary Agreements who would have a valid claim for a fee or commission from Seller in connection with such transactions by reason of any action taken by or on behalf of Purchaser, Parent or Opco.

Section 4.4 Financing. Purchaser and Parent will collectively have funds sufficient to pay (i) the Closing Cash Payment on the Closing Date and (iii) the Earnouts, if and when applicable.

Section 4.5 Litigation. There are no lawsuits, claims or any civil, administrative or criminal actions, suits, or proceedings or governmental investigations existing, pending, or to the Knowledge of Purchaser, threatened, with respect to this Agreement or the transactions contemplated hereby. None of Purchaser, Parent or Opco is subject to any decree or order of any Governmental Authority that would impair or delay its ability to perform its obligations under this Agreement or the Ancillary Agreements.

ARTICLE V

COVENANTS OF SELLER PRIOR TO CLOSING

Section 5.1 Conduct of the Product Business Prior to Closing.

(a) Subject to Applicable Law or as contemplated by this Agreement or consented to in writing by the Purchaser, Seller shall, consistent with its conduct of the Product Business during the twelve (12) months prior to the Agreement Date: (i) continue and conduct the Product Business in Seller’s ordinary and usual course of business, (ii) preserve intact the market for the Product and the goodwill associated with the Product and the Product Intellectual Property, (iii) preserve in full force and effect, and, other than in the ordinary course of business, not amend or alter, any material Contracts and/or any Assumed Contract, (iv) alter its marketing practices in respect of the Product in a manner intended to increase sales of Product prior to Closing, including the offering of incentives which are inconsistent with past practices, (v) sell the Product only in the ordinary course of business and at levels consistent with past practices for comparable periods of time and (vi) continue to maintain its relationships with suppliers, distributors, customers and others having material business relationships with it related to the Product Business.

(b) Between the Agreement Date and the Closing, Seller shall not take any affirmative action which would reasonably be expected to (i) cause Seller to violate Section 5.1(a), or (ii) have a Material Adverse Effect on the Product Business, or with, respect to (i) or (ii), refrain from taking any action which would be reasonably be expected to prevent such an event.

Section 5.2 Notice of Default. Between the Agreement Date and the Closing, Seller shall promptly notify Purchaser in writing if Seller becomes aware of any fact or condition that constitutes a breach of a representation, warranty or covenant of Seller under this Agreement. Any such notice or disclosure shall not be deemed to amend or supplement Seller’s disclosure under Article III or any schedule hereto, or to correct or cure any misrepresentation, breach of warranty or breach of covenant.

Section 5.3 No Negotiation. Seller shall not, and shall direct its representatives not to, directly or indirectly, initiate, solicit or knowingly encourage any Acquisition Proposal, or furnish any information to any other Person with respect to, or agree to or otherwise enter into, any Acquisition Proposal. Seller shall promptly notify Purchaser after receipt of any Acquisition Proposal or any request for information relating to the Purchased Assets or the Product Business by any Person who has informed Seller or any of its representatives that such Person is considering making, or has made, an Acquisition Proposal (which notice shall identify the Person making, or considering making, such Acquisition Proposal and shall set forth the material terms of any Acquisition Proposal received), and Seller shall keep Purchaser informed in reasonable detail of the terms, status and other pertinent details of any such Acquisition Proposal or request. Seller shall, and shall direct its representatives to, discontinue any solicitation efforts or negotiations with respect to or in furtherance of any Acquisition Proposal.

Section 5.4 Commercially Reasonable Efforts. Seller shall use commercially reasonable efforts to cause the conditions in Section 7.1 and 7.2 to be satisfied.

Section 5.5 Notice of Government Investigations. Between the Agreement Date and the Closing, Seller shall promptly notify Purchaser in writing if Seller has received any notice from the U.S. Department of Justice, the Office of the Inspector General or any other Governmental Authority that such Governmental Authority has commenced, threatened or intends to commence any action or investigation with respect to the Product Business.

ARTICLE VI

COVENANTS OF PURCHASER AND PARENT PRIOR TO CLOSING

Section 6.1 Notice of Default. Between the Agreement Date and the Closing, Purchaser, Parent and Opco shall promptly notify Seller in writing if Purchaser, Parent or Opco becomes aware of any fact or condition that constitutes a breach of a representation, warranty or covenant of Purchaser, Parent or Opco under this Agreement. Any such notice or disclosure shall not be deemed to amend or supplement Purchaser’s, Parent’s or Opco’s disclosure under Article IV or any schedule hereto, or to correct or cure any misrepresentation, breach of warranty or breach of covenant.

Section 6.2 Commercially Reasonable Efforts. Purchaser, Parent and Opco shall use commercially reasonable efforts to cause the conditions in Section 7.1 and 7.3 to be satisfied.

ARTICLE VII

CLOSING AND TERMINATION

Section 7.1 Conditions Precedent to Obligations of Parties. The respective obligations of Purchaser, Parent, Opco and Seller to consummate the transactions contemplated by this Agreement on the Closing Date are subject to the satisfaction or waiver at or prior to the Closing Date of the following conditions:

(a) No Injunction, etc. No Governmental Authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any Law which is in effect on the Closing Date which would, and no Proceeding by any Governmental Authority shall have been threatened against any of the Parties or any of the officers or directors of any of them seeking to, prohibit, enjoin or restrain the consummation of the transactions contemplated by this Agreement to occur on the Closing Date or otherwise making such transactions illegal.

(b) Regulatory Authorizations. (i) All material consents of Governmental Authorities shall have been obtained and shall be in full force and effect, and (ii) the waiting period under the HSR Act, if applicable, and other any other applicable Antitrust Regulation shall have expired or been terminated.

Section 7.2 Conditions Precedent to Purchaser’s Obligations. Purchaser’s obligations to consummate the transactions contemplated by the Transaction Documents shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Purchaser’s sole discretion, in writing by the Purchaser:

(a) Representations and Warranties. The representations and warranties of Seller in Article III (i) shall have been accurate in all material respects on the Agreement Date and

(ii) shall be accurate in all material respects on the Closing Date as if made on the Closing Date (except to the extent that any such representation or warranty is made as of a specified date, in which case such representation or warranty shall be accurate in all material respects as of such date), and Purchaser shall have received a certificate signed on behalf of Seller by an authorized officer of Seller to such effect.

(b) Performance. Seller shall have performed and complied in all material respects with all covenants contained in this Agreement that are required to be performed or complied with by it on or prior to the Closing.

(c) FDA. With respect to the Product fermentation failure previously disclosed to the FDA by Seller, the FDA shall have approved in writing the Prior-Approval Supplement filed with the FDA by Seller on March 9, 2012 and as supplemented on May 10, 2012 (a true and complete copy of which shall have been provided to Purchaser) and the release and sale of the Product under the B-I Purchase Orders, and Seller shall have delivered such written approval(s) to Purchaser.

(d) No Material Adverse Effect. Since the date of this Agreement, no Material Adverse Effect shall have occurred and be continuing.

(e) B-I Supply Agreements. (i) Purchaser, on behalf of itself and Opco, shall have agreed to accept the B-I Supply Agreement, (ii) Boehringer-Ingelheim shall have waived its right to terminate the B-I Supply Agreement upon or following assignment of such agreement to Purchaser and (iii) Boehringer-Ingelheim shall have consented in writing to the assignment of the B-I Supply Agreement and Quality Agreement to Opco, each of Sections 7.2(e)(i)-(iii) in the form attached hereto as Exhibit E.

(f) Genentech License. Seller shall have delivered to Purchaser the consent of Genentech Inc. to the assignment of the Genentech License to Purchaser.

(g) Closing Documents. Purchaser shall have received the documents set forth in Sections 2.7(a) – (i) and any document reasonably requested by Purchaser pursuant to Section 2.7(j) provided that Purchaser shall have made such request for such document no less than ten (10) days prior to the Closing. Such documents shall have been executed by the parties thereto and shall be in full force and effect.

Section 7.3 Conditions Precedent to Seller’s Obligations. Seller’s obligation to consummate the transactions contemplated hereby shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Seller’s sole discretion, in writing by Seller:

(a) Representations and Warranties. The representations and warranties of Purchaser, Parent and Opco contained in this Agreement shall have been accurate in all material respects on the date of this Agreement and shall be accurate in all material respects as of the Closing Date as if made on and as of the Closing Date (except to the extent that any such representation or warranty is made as of a specified date, in which case such representation or warranty shall be accurate in all material respects as of such date, except for such inaccuracies that, either individually or in the aggregate, have not had a material adverse effect on Purchaser, Parent or

Opco, as applicable, and Seller shall have received a certificate signed on behalf of each of Purchaser, Parent and Opco by an authorized officer of Purchaser, Parent and Opco, as applicable, to such effect).

(b) Performance. Purchaser, Parent and Opco shall each have performed and complied in all material respects with all covenants contained in this Agreement that are required to be performed or complied with by them on or prior to the Closing, and Seller shall have received a certificate signed on behalf of each of Purchaser, Parent and Opco by an authorized officer of Purchaser, Parent and Opco, as applicable, to such effect.

(c) Closing Documents. Purchaser shall have executed and delivered to Seller the documents set forth in Sections 2.6(a) – (g) and any document reasonably requested by Seller pursuant to Section 2.6(h) provided that Seller shall have made such request for such document no less than ten (10) days prior to the Closing, and each such agreement and document shall be in full force and effect.

Section 7.4 Termination. This Agreement may be terminated:

(a) at any time before the Closing Date by mutual written consent of Purchaser, Parent, Opco and Seller; or

(b) by Purchaser, Parent, Opco or Seller, in writing, if the transactions contemplated hereby have not been consummated on or before October 31, 2012 (as such date may be extended pursuant to Section 10.6), provided that such failure is not due to the failure of the Party seeking to terminate this Agreement to comply in all material respects with its obligations under this Agreement, including the failure of the Party seeking to terminate this Agreement to satisfy its closing conditions set forth in this Article VII.

Section 7.5 Procedure and Effect of Termination. Upon termination of this Agreement by Purchaser, Parent, Opco or Seller pursuant to Section 7.4, written notice thereof shall forthwith be given to the other Parties and this Agreement shall terminate and the transactions contemplated hereby shall be abandoned without further action by any of the Parties. Termination of this Agreement shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in: (i) this Section 7.5, ARTICLE IX, and Section 10.1; (ii) the Confidentiality Agreement; and (iii) any other provisions of this Agreement which by their nature are intended to survive any such termination.

ARTICLE VIII

CERTAIN OTHER COVENANTS

Section 8.1 Necessary Efforts; No Inconsistent Action.

(a) Subject to the other terms and conditions of this Agreement, including the conditions set forth in Article VII, the Parties shall, and shall cause their respective Affiliates to, use their respective commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable under Applicable Law to consummate and make effective the transactions contemplated by the Transaction Documents and to use their respective commercially reasonable efforts to cause the conditions to each

Party’s obligation to close the transactions contemplated hereby as set forth in Article VII to be satisfied, including all actions necessary to obtain all Consents and all waivers or terminations of applicable waiting periods required for the satisfaction of the conditions set forth in Section 7.1(b), and all other Consents necessary in connection with the consummation of the transactions contemplated by the Ancillary Agreements; provided, however, that the foregoing provisions of this Section 8.1(a) shall not (i) require any Party to perform, satisfy or discharge any obligations of any other Party under this Agreement or otherwise or (ii) subject to the provisions of Section 2.9, require any Party or its Affiliates to expend any money other than for filing fees or expenses or de minimus costs or expenses or agree to any restrictions in order to obtain any Consents. The Parties shall cooperate fully with each other to the extent necessary in connection with the foregoing.

(b) In connection with the efforts referenced in Section 8.1(a), the Parties shall timely and promptly make all filings which may be required for the satisfaction of the condition set forth in Section 7.1(b) by each of them in connection with the consummation of the transactions contemplated hereby. In furtherance and not in limitation of the foregoing, if required under Applicable Law, each Party shall file, or cause to be filed, Notification and Report Forms under the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), or any other similar filings under Antitrust Regulations of any other Governmental Authority as promptly as practicable following the date of this Agreement and in any event no later than (i) ten (10) Business Days following the date of this Agreement, in the case of Notification and Report Forms under the HSR Act, and (ii) the time prescribed by Applicable Law in the case of requirements under other applicable Antitrust Regulations to the extent a time is prescribed and, if no time is prescribed, as promptly as reasonably practicable. In addition, the Parties shall, and shall cause their respective Affiliates to, cooperate and use their commercially reasonable efforts and take all actions necessary to (A) respond as promptly as practicable to any requests for information from any Governmental Authority, and to avoid and/or overcome any action, including any legislative, administrative or judicial action, and (B) have vacated, lifted, reversed or overturned any judgment, injunction or other order (whether temporary, preliminary or permanent) that restricts, prevents or prohibits, or could restrict, prevent or prohibit, the consummation of the transactions contemplated by this Agreement; provided, however, that in no event shall Seller or any of its Affiliates be required or expected to retain any of the Purchased Assets in order to comply with its obligations in respect of the foregoing. Each Party shall furnish to the other such necessary information and assistance as the other Party may reasonably request in connection with the preparation of any necessary filings or submissions by it to any Governmental Authority. Except as prohibited or restricted by Applicable Law or any Antitrust Regulations, each Party or its attorneys shall provide the other Party or its attorneys the opportunity to make copies of all correspondence, filings or communications (or memoranda setting forth the substance thereof) between such Party or its representatives, on the one hand, and any Governmental Authority, on the other hand, with respect to the Transaction Documents or the transactions contemplated thereby, subject to redaction as reasonably necessary of documents filed pursuant to Item 4(c) of the Hart Scott Rodino Notification and Report Form. Without in any way limiting the foregoing, the Parties shall consult and cooperate with one another, and consider in good faith the views of one another, in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any Party in connection with proceedings under or relating to the HSR Act or any other Antitrust Regulation.

Section 8.2 Public Disclosures. Unless otherwise required by Applicable Law, the rules and regulations of any stock exchange or quotation services on which such Party’s stock is traded or quoted, prior to the Closing Date, no news release or other public announcement pertaining to the transactions contemplated by this Agreement will be made by or on behalf of a Party or its Affiliates without the prior written approval of the other Party (which approval shall not be unreasonably withheld, conditioned or delayed). If in the judgment of any Party such a news release or public announcement is required by Applicable Law or the rules or regulations of any stock exchange on which such Party’s stock is traded, the Party intending to make such release or announcement shall to the extent practicable use commercially reasonable efforts to provide prior written notice to the other Party of the contents of such release or announcement and to allow the other Party reasonable time to comment on such release or announcement in advance of such issuance.

Section 8.3 Product Returns, Rebates and Chargebacks. Product Returns, Commercial Rebates and Chargebacks are to be processed by the Parties in accordance with the provisions of the Transition Services Agreement.

Section 8.4 Transitional Trademark License.

(a) As of the Closing Date and for a period of up to twenty-four months (24) months after the Closing Date, Seller hereby grants to Purchaser (or its Affiliates responsible for operating the Product Business after Closing or any Third Party manufacturers utilized by Purchaser in connection with the Product Business after the Closing Date), and Purchaser hereby accepts, a non-exclusive, non-transferable, non-sublicensable (except with respect to such Third Party manufacturers or Purchaser’s Affiliates), royalty-free, paid-up, license in the Territory under the Seller Marks, for use solely in connection with (i) Purchaser’s sale of the Inventory in the Territory, and (ii) Purchaser’s use of the Promotional Materials existing as of the Closing Date and transferred to Purchaser as part of the Purchased Assets, and (iii) the labeling on the Product manufactured by or on behalf of Purchaser as of and after the Closing; provided, however, that such license is being granted solely for transitional purposes and Purchaser shall therefore, notwithstanding the time period provided for above, use its commercially reasonable efforts to as quickly as is reasonably possible cease its use of the Seller Marks after the Closing, but in no event later than twenty-four (24) months after the Closing Date, or such later date (not to exceed an additional six (6) months) upon consent by Seller, such consent not be unreasonably withheld.

(b) To the extent that Purchaser is utilizing the transitional trademark license set forth in Section 8.4(a), Purchaser shall not (i) add any marks to, or otherwise alter, the Seller Marks as used in the Product Business as of the Closing Date (except as required by Applicable Law); (ii) change in any way the style of the Seller Marks as used in the Product Business as of the Closing Date; or (iii) otherwise use the Seller Marks in any manner other than as specifically provided in this Section 8.4.

(c) Purchaser acknowledges Seller’s ownership of the Seller Marks, shall do nothing inconsistent with such ownership, and agrees not to challenge Seller’s title to the Seller Marks. Nothing in this Agreement shall give Purchaser any right, title or interest in the Seller Marks other than the right to use the Seller Marks strictly in accordance with this Section 8.4. All use

of the Seller Marks by Purchaser under this Section 8.4 shall conform to the standards followed by Seller in operating the Product Business prior to the Closing Date, and Seller shall have the right to review the standards used by Purchaser to operate the Product Business after the Closing Date to ensure Purchaser’s compliance with this requirement related to the Seller Marks.

(d) Purchaser shall not have the right to, and shall not, sublicense, assign, pledge, grant or otherwise encumber or transfer to any Third Party any rights licensed by Seller to Purchaser under Section 8.4(a) without Seller’s prior written consent. The Parties understand and agree that, in addition to all other legal remedies, Seller shall be entitled to immediate injunctive relief in order to enforce the terms of this Section 8.4.

(e) Nothing in this Section 8.4, or any other provision of this Agreement or any provision of the Ancillary Agreements, shall grant the Purchaser any rights in any of Seller’s Internet domain names, registrations or applications for registration, or renewals thereof, registered in the United States or any other country or jurisdiction throughout the world, except as such Internet domain names, registrations or applications for registration, or renewals thereof are included as part of the Purchased Assets.

(f) Following the Closing, Purchaser shall promptly and at its own expense use commercially reasonable efforts to obtain such FDA approvals necessary for Purchaser Labeling for the Product to be manufactured after the Closing and, promptly comply with such FDA approvals upon receipt thereof.

Section 8.5 Customer Billing. In the event that Seller or any of its Affiliates receives payment after the Closing Date on invoices relating to the Product Business operated by the Purchaser or sales of products or services rendered by Purchaser on or after the Closing, Seller will promptly notify Purchaser of such receipt and will promptly remit, or will cause such Affiliate to promptly remit, such payment to Purchaser without depositing such payment in an account of Seller, or such Affiliate, unless in error, and Seller, or such Affiliate, shall not be entitled to offset such payment against any payments due Seller from Purchaser. In the event Seller receives an invoice or request for payment relating to the operation of the Product Business on or after the Closing Date, or with respect to any Assumed Liability, Seller will promptly notify Purchaser of such request or invoice and forward the invoice and all other appropriate information to Purchaser for payment. In the event Purchaser or any of its Affiliates receive payment after the Closing Date on invoices issued by Seller relating to an Excluded Asset (such as Seller’s accounts receivable as of the Closing Date) or relating to product sold or services rendered by businesses other than the Product Business or the Purchased Assets, Purchaser will promptly notify Seller of such receipt and will promptly remit, or will cause such Affiliate to promptly remit, such payment to Seller without depositing such payment in an account of Purchaser, or such Affiliate, unless in error, and Purchaser, or such Affiliate, shall not be entitled to offset such payment against any payments due Purchaser from Seller.

Section 8.6 Cooperation.

(a) After the Agreement Date, the Parties shall cooperate reasonably with each other in connection with any reasonable actions required to be taken with respect to their respective obligations under this Agreement and the Ancillary Agreements, and shall (i) furnish upon

reasonable request to each other such further information, and (ii) execute and deliver to each other such other reasonable documents, and (iii) do such other acts, all as the other Party may reasonably request for the purpose of carrying out the provisions of this Agreement (and the Ancillary Agreements) and the transactions contemplated hereby and thereby.

(b) The Parties will promptly notify each other in writing, of any event or fact which represents a material breach of any of their respective representations, warranties, covenants or agreements hereunder.

Section 8.7 Reserved.

Section 8.8 Tax Matters.

(a) Seller and Purchaser shall provide reasonable cooperation and information to each other in connection with (i) the preparation or filing of any Tax Return, Tax election, Tax consent or certification, or any claim for a Tax refund, (ii) any determination of liability for Taxes and (iii) any audit, examination or other proceeding in respect of Taxes related to the Product Business. Seller and Purchaser shall make themselves (and their respective employees) reasonably available on a mutually convenient basis to provide an explanation of any documents or information provided under this Section 8.8(a). Each of Seller and Purchaser shall retain all Tax Returns, work papers and all material records or other documents in its possession (or in the possession of its Affiliates) relating to Tax matters of the Product Business for any taxable period that includes the Closing Date and for all prior taxable periods until the later of (i) the expiration of the statute of limitations of the taxable period to which such Tax Returns and other documents relate, without regard to extensions, or (ii) six (6) years following the due date (without extension) for such Tax Returns. Prior to the expiration of such time, if Seller or Purchaser desire to retain any such documents in the other’s possession (or in the possession of the other party’s Affiliates), such party desiring to retain such document shall give notice to the other party at least ninety (90) days’ prior to the later of (i) the expiration of the statute of limitations of the taxable period to which such Tax Returns and other documents relate, without regard to extensions, or (ii) six (6) years following the due date (without extension) for such Tax Returns, requesting that such other party remove and retain all or any part of the such documents (at such party’s request). Any information obtained under this Section 8.8(a) shall be kept confidential pursuant to Section 10.1, except as may be otherwise necessary in connection with the filing of Tax Returns, claims for a Tax refund or in conducting any audit, examination or other proceeding in respect of Taxes.

(b) Purchaser and Seller shall each be responsible for fifty percent (50%) of all sales, use, transfer, value added and other similar Taxes (the “Transfer Taxes”), if any, arising out of the transfer by Seller of the Purchased Assets to Purchaser pursuant to this Agreement; provided that, Seller shall have no responsibility for, and Purchaser will be solely responsible for, any value added Tax payable in connection with the sale, assignment, transfer, conveyance and delivery to Purchaser of the Inventory identified on Schedule 1.1(a) and the Product under the B-I Purchase Orders pursuant to Section 2.1(c).

(c) All real property, personal property and similar ad valorem Taxes (collectively, “Property Taxes”) levied with respect to the Purchased Assets for the Tax period in which the

Closing Date occurs (a “Straddle Period”) shall be apportioned between Purchaser and Seller based on the number of days of such Straddle Period included in the portion of such period ending on the Closing Date (the “Pre-Closing Tax Period”) and the number of days of such Straddle Period included in the portion of such period beginning after the Closing Date (the “Post-Closing Tax Period”). Seller shall be liable for the proportionate amount of such Property Taxes that is attributable to the Pre-Closing Tax Period, and Purchaser shall be liable for the proportionate amount of such Property Taxes that is attributable to the Post-Closing Tax Period. Upon receipt of any bill for such Property Taxes, Purchaser or Seller, as applicable, shall present a statement to the other setting forth the amount of reimbursement to which each is entitled under this Section 8.8(c) together with such supporting evidence as is reasonably necessary to calculate the proration amount. The proration amount shall be paid by the party owing it to the other within ten (10) days after delivery of such statement.

(d) Purchaser and Seller agree and acknowledge that no withholding of Taxes is required under Irish or other Applicable Law with respect to any of the payments contemplated by Section 2.1 and that no payments under Section 2.1 shall be reduced by any withholding Taxes.

Section 8.9 Notice to Customers. Seller agrees to cooperate with Purchaser, at Purchaser’s reasonable request, in the notification to customers of the transactions contemplated by this Agreement and Seller agrees not to notify any customer of such transactions without the consent of Purchaser. Such notification shall be in such form as is reasonably satisfactory to both Purchaser and Seller as agreed to prior to Closing.

Section 8.10 Adverse Experience Reports. At a mutually agreed upon time after the Closing, Seller shall provide Purchaser with information relating to the investigation and reporting of all adverse experiences regarding the Product prior to the Closing and all other information which is materially relevant to the safe use of the Product in Seller’s possession as of the Closing. After the Closing, Seller shall promptly submit to Purchaser all adverse drug experience information or customer complaints brought to the attention of Seller in respect of the Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Product. After the Closing and after the time the appropriate Governmental Authorities are notified of the transfer of the applicable Regulatory Approvals, Purchaser shall have all responsibility for required reporting of adverse experiences for the Product.

Section 8.11 Regulatory Matters.

(a) Except as expressly set forth in Section 8.10 or the Transition Services Agreement, from and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for (i) taking all actions, paying all fees and conducting all communication with the appropriate Governmental Authority required by Applicable Law in respect of the Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of such Regulatory Approval), (ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering or

contamination, and (iii) investigating all complaints and adverse drug experiences in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval).

(b) From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (and in any event within the time periods required by Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of the Product. In addition, Seller shall cooperate with Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the investigation of and response to any complaint or adverse drug experience related to the Product sold by Seller.

(c) From and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and reasonable credits extended to customers in connection with the recall. Seller shall notify Purchaser promptly in the event that a recall of the Product sold by Seller is necessary.

(d) Seller shall, within fifteen (15) days after the Closing, notify the FDA of the transfer of the Regulatory Approvals to Purchaser in accordance with all Applicable Laws.

Section 8.12 Product Records. At the Closing, or as soon as possible thereafter, Seller shall transfer to Purchaser, to the extent in Seller’s actual possession, the original copies of the Product Records and Assumed Contracts. Seller may retain one (1) archival copy of the Product Records and Assumed Contracts solely for archival purposes or as required by Applicable Law. Prior to delivering or making available any Product Records to Purchaser, Seller shall be entitled to redact therefrom any information that does not relate to the Product Business.

Section 8.13 Employees. The Parties acknowledge and agree that there is no intent or agreement that any employee of Seller will terminate his or her employment with Seller and/or commence employment with Purchaser as a result of the transactions contemplated by this Agreement.

Section 8.14 Non-Competition.

(a) Seller hereby covenants and agrees that, for a period of five (5) years from the Closing Date, neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall (i) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product and/or any Competing Product, for any use, purpose, indication or treatment (whether for the treatment of idiopathic pulmonary fibrosis, or any other disease or disorder), anywhere in the Territory or elsewhere in the world, (ii) engage in

any aspect of the Product Business, (iii) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, with any Governmental Authority in the Territory or elsewhere in the world, with respect to the Product and/or any Competing Product, for any use, purpose, indication or treatment (whether for the treatment of idiopathic pulmonary fibrosis, or any other disease or disorder) and/or (iv) use any of the Excluded Assets or IPF Patient Data to engage in any conduct prohibited under Sections 8.14(a)(i)-(iii); provided that this Section 8.14(a) shall not apply to non-affiliated successors or assigns of Seller.

(b) Purchaser, Parent and Opco hereby covenant and agree that, for a period of five (5) years from the Closing Date, neither Purchaser, Parent, Opco nor any of their respective Affiliates (either alone or in collaboration with any Third Party) shall (i) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product for the treatment of idiopathic pulmonary fibrosis, anywhere in the Territory or elsewhere in the world, and/or (ii) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submission, with any Governmental Authority in the world, with respect to the Product for the treatment of idiopathic pulmonary fibrosis. For clarity, except as set forth in Section 2.10, nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed to prevent, limit, restrict or impair Purchaser’s right to, for example but without limitation, (1) make, use, develop, promote, advertise, market, distribute, sell, offer to sell, import, export and/or commercialize the Product for any use, purpose, indication or treatment (other than for the treatment of idiopathic pulmonary fibrosis), anywhere in the Territory or elsewhere in the world, in each case, whether alone, or as a mixture or in combination with any variation(s) or any analog polypeptide(s) of the Product and/or with any other biologic(s), product(s) or composition(s), (2) file any applications for regulatory approval, including new drug applications, abbreviated new drug applications, new drug submissions, and any comparable applications and submissions, with any Governmental Authority in the Territory or elsewhere in the world, with respect to the Product for any use, purpose, indication or treatment (other than for the treatment of idiopathic pulmonary fibrosis), in each case, whether alone, or as a mixture or in combination with any variation(s) or any analog polypeptide(s) of the Product and/or with any other biologic(s), product(s) or composition(s), and/or (3) use the Product and/or any of the Product Intellectual Property to develop improvements or enhancements to the Product for purposes of engaging in any of the conduct described in this Section 8.14(b)(1)-(2); provided that this Section 8.14(b) shall not apply to non-affiliated successors or assigns of Purchaser. Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall prevent, limit, restrict or impair any of Purchaser’s rights set forth in this Section 8.14(b).

(c) Nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed as a waiver, disclaimer, abridgment, abrogation or truncation of any of Purchaser’s, Parent’s, Opco’s and/or any of their respective Affiliates’ rights, titles and/or interests in and to the Product Intellectual Property and/or in and to any Intellectual Property owned or licensed (as licensor or licensee) by Purchaser, Parent, Opco and/or any of their respective Affiliates. For the avoidance of doubt, nothing in this Section 8.14 or in the Transaction Documents shall operate or be construed as assigning, conveying, transferring or granting to Seller and/or any of its Affiliates any rights, titles, interests, licenses or authorities in and to any of the Product Intellectual Property and/or in and to any Intellectual Property owned or licensed (as licensor or licensee) by Purchaser, Parent, Opco and/or any of their respective Affiliates.

(d) In order to receive the full benefit of the bargain under the Transaction Documents, the Parties hereto have knowingly and voluntarily entered into, and intend to be fully and legally bound to, the restrictive covenants of this Section 8.14, including, without limitation, as to the defined territory, duration, and prohibited conduct set forth in this Section 8.14.

Section 8.15 Seller’s Additional Covenants and Agreements.

(a) Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall, at any time on or subsequent to the Closing Date, challenge or otherwise contest before any Governmental Authority or via any Proceeding (i) Purchaser’s right, title and interest in and to the Product, the Product Business, and the Product Intellectual Property, (ii) the validity and/or the enforceability of any of the Product Intellectual Property, (iii) Purchaser’s right to seek and obtain any copyright, patent and/or trademark protection for the Product, the Product Business, and/or any of the Product Intellectual Property, (iv) the validity and/or the enforceability of any copyright(s), patent(s) and/or trademark(s) so obtained by Purchaser for the Product, the Product Business, and/or any of the Product Intellectual Property, (v) Purchaser’s right to retain any and all income, revenue, profit, royalties, damages, claims and payments attributable thereto, payable in connection therewith, or otherwise derived therefrom, without any duty to account to Seller (excepted as otherwise provided under this Agreement), (vi) Purchaser’s right to bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property, (vii) Purchaser’s right to exploit the Product Intellectual Property for whatever purposes Purchaser shall elect to pursue, including, without limitation, improvements, combinations and analogies thereof and commercialization for new uses and indications (other than for the treatment of idiopathic pulmonary fibrosis) or as otherwise restricted by the terms of this Agreement, and (viii) Purchaser’s right to any and all rights, titles and interests corresponding to the foregoing throughout the world.

(b) Seller hereby covenants and agrees that neither Seller nor any of its Affiliates (either alone or in collaboration with any Third Party) shall, at any time on or subsequent to the Closing Date (i) undertake any action that may damage, diminish, impair or infringe upon, any of Purchaser’s right, title and/or interest in and to the Product, the Product Business, and/or any of the Product Intellectual Property, (ii) assist any Third Party in challenging or otherwise contesting Purchaser’s rights, titles and interests in and to the Product, the Product Business and/or any of the Product Intellectual Property, anywhere in the world, (iii) use any of the Product Intellectual Property, and/or (iv) obtain or assert any right(s), title(s) or interest(s) to any patent, trademark or copyright relating to the Product, the Product Business and/or any of the Product Intellectual Property.

(c) To the extent that Seller, at the time of Closing, has any right, title or interest in Intellectual Property which, subsequent to Closing, Seller reasonably determines would materially prevent, limit, restrict or impair Purchaser’s ability to (i) commercialize the Product, (ii) engage in the Product Business, (iii) exercise or exploit any of the Product Intellectual

Property, and/or (iv) bring any and all causes of action, either in law or in equity, for past, present or future infringement of any of the Product Intellectual Property, (the “Additional Intellectual Property”), the Seller shall notify Purchaser of such determination and the Parties will work in good faith to provide Purchaser with the rights to such Additional Intellectual Property solely in the Product Business.

ARTICLE IX

INDEMNIFICATION

Section 9.1 Indemnification.

(a) Subject to the terms and conditions of this Article IX, from and after the Closing, Seller shall indemnify, reimburse, defend and hold harmless Purchaser, its Affiliates and their respective officers, directors, managers, employees, stockholders, members, agents, successors and assigns (collectively, the “Purchaser Indemnified Parties”) from and against, and shall compensate and reimburse each Purchaser Indemnified Party, for any and all Losses incurred by such Purchaser Indemnified Party to the extent arising or resulting from:

(i) any inaccuracy or breach of any representation or warranty of Seller contained in this Agreement;

(ii) any breach of any covenant or agreement of Seller contained in this Agreement or in any of the Ancillary Agreements; or

(iii) the failure of Seller or any of its Affiliates to pay, perform or discharge any Excluded Liabilities; or

(iv) any Third Party claim by a Third Party relating to the conduct of the Product Business by Seller or any of its Affiliates prior to the Closing.

(b) Subject to the terms and conditions of this Article IX, from and after the Closing, Purchaser, Parent and Opco shall, jointly and severally, indemnify, reimburse, defend and hold harmless Seller, its Affiliates and their respective officers, directors, managers, employees, stockholders, agents, successors and assigns (collectively, the “Seller Indemnified Parties”) from and against, and shall compensate and reimburse each Seller Indemnified Party for, any and all Losses incurred by such Seller Indemnified Party to the extent arising or resulting from:

(i) any inaccuracy or breach of any representation or warranty of Purchaser, Parent or Opco contained in this Agreement;

(ii) any breach of any covenant or agreement of Purchaser, Parent or Opco contained in this Agreement or in any of the Ancillary Agreements;

(iii) the failure of Purchaser or any of its Affiliates to pay, perform or discharge any Assumed Liabilities; or

(iv) any Third Party Claim by a Third Party relating to the conduct of the Product Business by Purchaser of any of its Affiliates from and after Closing, except to

the extent such Third Party Claim arises directly out of (1) any inaccuracy or breach of any representation or warranty of Seller contained in this Agreement or in any of the Ancillary Agreements, or (2) the negligence, recklessness, bad faith, or intentional wrongful acts or omissions of Seller or its Affiliates.

(c) NOTWITHSTANDING THE FOREGOING, PURCHASER LOSSES AND SELLER LOSSES SHALL NOT INCLUDE, AND IN NO EVENT SHALL ANY PURCHASER LOSSES OR SELLER LOSSES BE RECOVERABLE UNDER THE TERMS OF THIS AGREEMENT TO THE EXTENT SUCH DAMAGES CONSIST OF PUNITIVE, SPECIAL OR EXEMPLARY DAMAGES, EXCEPT TO THE EXTENT SUCH PUNITIVE, SPECIAL OR EXEMPLARY DAMAGES ARE AWARDED AGAINST ANY PURCHASER INDEMNIFIED PARTY OR SELLER INDEMNIFIED PARTY, AS THE CASE MAY BE, IN A THIRD-PARTY CLAIM.

Section 9.2 Certain Limitations. Notwithstanding anything to the contrary contained in this Agreement, each of the following limitations shall apply:

(a) Seller will not be required to indemnify Purchaser under Sections 9.1(a)(i) (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), or attributable to fraud or intentional misconduct, as to which this Section 9.2(a) shall not apply), except to the extent that the cumulative amount of the Losses under Section 9.1(a)(i) incurred by the Purchaser Indemnified Parties exceeds Two Hundred Fifty Thousand Dollars (U.S. $250,000) (the “Basket Amount”) at which point Seller will be required to pay, and will have Liability for, the cumulative amount of the Losses under Section 9.1(a)(i) incurred by the Purchaser Indemnified Parties.

(b) Purchaser, Parent and Opco will not be required to indemnify Seller under Section 9.1(b)(i) (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.), or attributable to fraud or intentional misconduct, as to which this Section 9.2(b) shall not apply) except to the extent that the cumulative amount of the Losses under Section 9.1(b)(i) incurred by the Seller Indemnified Parties exceeds the Basket Amount at which point Purchaser, Parent and Opco, jointly and severally, will be required to pay, and will have Liability for, the cumulative amount of the Losses under Section 9.1(b)(i) incurred by the Seller Indemnified Parties.

(c) In no event shall the aggregate out-of-pocket Liability of Seller for any Losses pursuant to Sections 9.1(a)(i) exceed Five Million Five Hundred Thousand Dollars (U.S. $5,500,000) (the “Cap”); provided, that Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Section 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters) and 3.12 (Brokers, Finders, etc.) shall not exceed the Purchase Price; provided, further, that the limitations set forth in this Section 9.2(c) shall not apply to Losses attributable to fraud or intentional misconduct.

(d) In no event shall the aggregate out-of-pocket Liability of Purchaser, Parent or Opco for any Losses pursuant to Sections 9.1(b)(i) (other than Losses incurred as a result of any

inaccuracy or breach of any representation or warranty contained in or attributable to fraud or intentional misconduct, as to which this Section 9.2(d) shall not apply) exceed the Cap; provided, that Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.) shall not exceed the Purchase Price; provided, further, that the limitations set forth in this Section 9.2(d) shall not apply to Losses attributable to fraud or intentional misconduct.

(e) In no event shall Seller, Purchaser, Parent or Opco have any Liability under Section 9.1(a)(i), or 9.2(b)(i), as the case may be, with respect to claims that are not properly asserted in writing prior to the date that is eighteen (18) months after the Closing Date (other than claims for Losses incurred as a result of any inaccuracy or breach of any representation or warranty attributable to fraud or intentional misconduct, as to which this Section 9.2(e) shall not apply); provided, however, that (i) claims for Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), 4.1 (Organization and Authority) or 4.3 (Brokers, Finders, etc.), may be asserted at any time prior to expiration of the applicable statute of limitations and (ii) claims attributable to fraud or intentional misconduct, will have no expiration date.

(f) The representations and warranties made by each Party in this Agreement shall survive the Closing and shall expire eighteen (18) months after the Closing Date and any Liability of any Party with respect to such representations and warranties (other than Losses incurred as a result of any inaccuracy or breach of any representation or warranty contained in (i) Sections 3.1 (Organization and Authority), 3.2(b) (Title to Purchased Assets), 3.9 (Tax Matters), 3.12 (Brokers, Finders, etc.), 4.1 (Organization and Authority) and 4.3 (Brokers, Finders, etc.), which shall expire upon expiration of the applicable statute of limitations, or (ii) attributable to fraud or intentional misrepresentation, as to which no expiration date shall apply; provided, however, that if, at any time prior to such expiration date, notice of any case for indemnification pursuant to Section 9.1(a) or Section 9.1(b), as the case may be, shall have been given prior to the applicable expiration date and such notice describes the circumstances with respect to which such indemnification claim relates, such indemnification claim shall survive until such time as such claim is finally resolved.

Section 9.3 Procedures for Third Party Claims and Excluded Liabilities.

(a) General Procedures. Promptly (but in no event later than ten (10) days) after the receipt by any Indemnified Party of a notice of any Proceeding by any Third Party that may be subject to indemnification under this Article IX, including any Proceeding relating to any Excluded Liability or Assumed Liability, such Indemnified Party shall give written notice of such Proceeding to the Indemnifying Party, stating in reasonable detail the nature and basis of each claim made in the Proceeding and the amount thereof, to the extent known, along with copies of the relevant documents received by the Indemnified Party evidencing the Proceeding and the basis for indemnification sought. Failure of the Indemnified Party to give such notice shall not relieve the Indemnifying Party from liability on account of this indemnification, except if and only to the extent that the Indemnifying Party is actually prejudiced thereby. Thereafter, the Indemnified Party shall deliver to the Indemnifying Party, promptly after the Indemnified Party’s receipt thereof, copies of all notices and documents (including court papers) received by

the Indemnified Party relating to the Proceeding. The Indemnifying Party shall have the right to assume the defense of the Indemnified Party against the Third Party Claim upon written notice to the Indemnified Party delivered within thirty (30) days after receipt of the particular notice from the Indemnified Party; provided, however, that the Indemnifying Party shall not have the right to assume the defense of the Third Party Claim if such Third Party Claim (x) seeks as a remedy the imposition of an equitable remedy that is binding upon Purchaser, Parent or Opco, the Purchased Assets or the Assumed Liabilities or (y) the amounts of Losses would be reasonably expected to exceed the amounts for which the Indemnifying Party is obligated to indemnify. So long as the Indemnifying Party has assumed the defense of the Third Party Claim in accordance herewith and notified the Indemnified Party in writing thereof, (i) the Indemnified Party may retain separate co-counsel at its sole cost and expense and participate in the defense of the Third Party Claim, it being understood that the Indemnifying Party shall pay all reasonable costs and expenses of counsel for the Indemnified Party after such time as the Indemnified Party has notified the Indemnifying Party of such Third Party Claim and prior to such time as the Indemnifying Party has notified the Indemnified Party that it has assumed the defense of such Third Party Claim, (ii) the Indemnified Party shall not file any papers or consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim without the prior written consent of the Indemnifying Party (not to be unreasonably withheld, conditioned or delayed) and (iii) the Indemnifying Party will not consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim (other than a judgment or settlement that is solely for money damages in an amount less than the remaining balance of the limitations on indemnity set forth in Section 9.2 and is accompanied by a release of all indemnifiable claims against the Indemnified Party) without the prior written consent of the Indemnified Party (not to be unreasonably withheld, conditioned or delayed). Whether or not the Indemnifying Party shall have assumed the defense, such Indemnifying Party shall not be obligated to indemnify and hold harmless the Indemnified Party hereunder for any settlement entered into without the Indemnifying Party’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed.

(b) Equitable Remedies. In the case of any Third Party Claims where the Indemnifying Party reasonably believes that it would be appropriate to settle such claim using equitable remedies (i.e., remedies involving the future use of the Purchased Assets), the Indemnifying Party and the Indemnified Party shall work together in good faith to agree to a settlement; provided, however, that no Party shall be under any obligation to agree to any such settlement.

(c) Treatment of Indemnification Payments; Insurance Recoveries. Any payment made pursuant to the indemnification obligations arising under this Agreement shall be treated as an adjustment to the Purchase Price to the extent allowable under Applicable Law. Any indemnity payment under this Agreement shall be decreased by any amounts actually received by the Indemnified Party under Third Party insurance policies with respect to such Damage prior to the time payment by the Indemnifying Party is due and payable under this Agreement (net of any premiums paid by such Indemnified Party under the relevant insurance policy and any costs incurred by such Indemnified Party in procuring such payment under such policy), each Party agreeing (i) to use commercially reasonable efforts to recover all available insurance proceeds and (ii) to the extent that any indemnity payment under this Agreement has been paid by the Indemnifying Party to or on behalf of the Indemnified Party prior to the receipt, directly or

indirectly, by the Indemnified Party of any net insurance proceeds under Third Party insurance policies on account of such Loss which duplicate, in whole or in part, the payment made by the Indemnifying Party to or on behalf of the Indemnified Party, the Indemnified Party shall remit to the Indemnifying Party an amount equal to the amount of the net insurance proceeds actually received by the Indemnified Party on account of such Loss which duplicate, in whole or in part, the payment made by the Indemnifying Party to or on behalf of the Indemnified Party.

(d) In connection with any actual or threatened Third Party Claims by, or actual or threatened litigation or other disputes with, Third Parties relating to Assumed Liabilities or Excluded Liabilities, any such claims, litigation and disputes being referred to as “claims” for purposes of this Section 9.3(d), the Indemnified Party shall cooperate in the defense by the Indemnifying Party of such claim (and the Indemnified Party and the Indemnifying Party agree with respect to all such claims that a common interest privilege agreement exists between them), including, (i) permitting the Indemnifying Party to discuss the claim with such officers, employees, consultants and representatives of the Indemnified Party as the Indemnifying Party reasonably requests, (ii) permitting the Indemnifying Party to have reasonable access to the properties, books, records, papers, documents, plans, drawings, electronic mail, databases and computers of the Indemnified Party at reasonable hours to review information and documentation relative to the claim, (iii) providing to the Indemnifying Party copies of documents and samples of the Product as the Indemnifying Party reasonably requests in connection with defending such claim, (iv) permitting the Indemnifying Party to conduct privileged interviews and witness preparation of officers, employees and representatives of the Indemnified Party as the Indemnifying Party reasonably requests, (v) preserving all properties, books, records, papers, documents, plans, drawings, electronic mail and databases included in the Purchased Assets relating to matters relating to Excluded Liabilities (in the case of the Purchaser) and Assumed Liabilities (in the case of Seller) in accordance with such Party’s corporate documents retention policies, or longer to the extent reasonably requested by the other Party in connection with any actual or threatened action that would reasonably be expected to result in a claim for indemnification hereunder, (vi) promptly collecting documents and extracting information from documents for the Indemnifying Party’s review and use, as the Indemnifying Party reasonably requests, or allowing the Indemnifying Party’s representatives to do the same, (vii) notifying the Indemnifying Party promptly of receipt by the Indemnified Party of any subpoena or other Third Party request for documents or interviews and testimony, (viii) providing to the Indemnifying Party copies of any documents produced by the Indemnified Party in response to or compliance with any subpoena or other Third Party request for documents, and (ix) permitting the Indemnifying Party to conduct such other reasonable investigations and studies, and take such other actions, as are reasonably necessary in connection with the Indemnifying Party’s defense or investigation of such claim. In connection with any claims, except to the extent inconsistent with the Indemnified Party’s obligations under Applicable Law and except to the extent that to do so would subject the Indemnified Party or its employees, agents or representatives to criminal or civil sanctions, (1) unless ordered by a court to do otherwise, the Indemnified Party shall not produce documents to a Third Party until the Indemnifying Party has been provided a reasonable opportunity to review, copy and assert privileges covering such documents, (2) the transfer to the Indemnified Party by the Indemnifying Party of documents covered by the Indemnifying Party’s attorney/client or work product privileges shall not constitute a waiver of such privileges, (3) unless otherwise ordered by a court, the Indemnified Party shall withhold from production to any Third Party any

documents as to which the Indemnifying Party asserts a privilege, (4) the Indemnified Party shall defend in court any such privilege asserted by the Indemnifying Party and (5) the Indemnified Party shall permit the Indemnifying Party to prepare any employees of the Indemnified Party required or requested to testify or otherwise be deposed or interviewed in connection with any claim and to be present during any such testimony or interviews.

Section 9.4 Certain Procedures. The Indemnified Party shall give the Indemnifying Party prompt written notice (an “Indemnification Claim Notice”) (but in no event more than thirty (30) days after discovery) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Section 9.1(a) or Section 9.1(b); provided, however, that failure to give such notice shall not relieve the Indemnifying Party of its obligations hereunder except to the extent it shall have been materially prejudiced by such failure. Each Indemnification Claim Notice must contain a reasonable description of the claim and the nature and amount of such Losses (to the extent the nature and amount of such Losses are known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party (but in no event more than thirty (30) days after discovery) copies of all papers and official documents received in respect of any Losses. All indemnification claims in respect of a Party, its Affiliates or their respective directors, stockholders, members, officers, managers, employees and agents shall be made solely by such Party to this Agreement.

Section 9.5 Guaranty. Parent hereby agrees to be responsible for, and guarantee to Seller, the full performance by Purchaser, a wholly-owned subsidiary of Parent, and Opco, an indirect, wholly-owned subsidiary of Purchaser, and agrees to cause Purchaser and Opco to perform, all of their respective obligations and liabilities under or in connection with this Agreement, the Ancillary Agreements and the transactions contemplated hereby and thereby. The liability of Parent under this Section 9.5 shall be irrevocable, absolute and independent.

Section 9.6 Remedies Exclusive. Following the Closing, with the exception of remedies based on fraud, the remedies set forth in this Article IX shall constitute the sole and exclusive remedy for money damages and shall be in lieu of any other remedies for money damages that may be available to the Indemnified Parties under any other agreement or pursuant to any statutory or common law with respect to any Losses of any kind or nature incurred directly or indirectly resulting from or arising out of any of this Agreement, the Purchased Assets, the Assumed Liabilities or the Excluded Liabilities (it being understood that nothing in this Section 9.6 or elsewhere in this Agreement shall affect the Parties’ rights to specific performance or other similar non-monetary equitable remedies with respect to the covenants referred to in this Agreement to be performed after the Closing). The Parties each hereby waive any provision of any Applicable Law to the extent that it would limit or restrict the agreement contained in this Section 9.6.

ARTICLE X

MISCELLANEOUS PROVISIONS

Section 10.1 Confidentiality.

(a) Reference is made to that certain letter agreement dated July 28, 2011, by and between Seller and Parent (the “Confidentiality Agreement”). As used in this Section 10.1, the

term “Evaluation Material” shall have the meaning assigned to such term in the Confidentiality Agreement. Upon the Closing, the Confidentiality Agreement shall expire and be of no further force and effect with respect to all Evaluation Material relating to the Product Business, the Purchased Assets or the Assumed Liabilities, but all such Evaluation Materials shall thereafter be governed by the provisions of Section 10.1(b); provided, however, such expiration of the Confidentiality Agreement shall in no way prejudice or adversely affect Seller’s ability to seek damages, or any other remedy available to Seller, with respect to a violation by Purchaser, Parent or Opco (or their respective Affiliates or representatives) of the Confidentiality Agreement prior to or after the Closing. Upon and after the Closing, the Confidentiality Agreement shall remain in full force and effect pursuant to its terms with respect to all other Evaluation Material that does not relate to the Product Business, the Purchased Assets or the Assumed Liabilities.

(b) From and after the Closing, all confidential information and all Evaluation Material relating to the Product Business, the Purchased Assets and the Assumed Liabilities shall constitute the “Purchaser Confidential Information” and shall be used by Seller solely as required to perform its obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law, and for no other purpose. Seller shall not disclose, or permit the disclosure of, any of the Purchaser Confidential Information to any Person except those Persons to whom such disclosure is necessary to permit Seller to perform its obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law. Seller shall treat, and will cause its Affiliates and the directors, officers, employees, agents, representatives and advisors of Seller or any of their Affiliates to treat, the Purchaser Confidential Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(c) All confidential information obtained by Purchaser, Parent or Opco (or their respective Affiliates or representatives) from Seller (or its Affiliates or representatives) other than the Purchaser Confidential Information (the “Seller Confidential Information”) shall be used by Purchaser, Parent and Opco solely as required to perform their respective obligations, exercise or enforce its rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law, and for no other purpose. Purchaser, Parent and Opco shall not disclose, or permit the disclosure of, any of Seller Confidential Information to any person except those persons to whom such disclosure is necessary to permit Purchaser, Parent and Opco to perform their respective obligations, exercise or enforce their respective rights under this Agreement (or any Ancillary Agreement), or comply with Applicable Law. Purchaser, Parent and Opco shall each treat, and will cause their respective Affiliates and the directors, officers, employees, agents, representatives and advisors of Purchaser, Parent and Opco or any of their Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Purchaser, Parent and Opco normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.

(d) In the event any Party is requested pursuant to, or required by, Applicable Law to disclose any of any other Party’s Confidential Information (i.e., Seller Confidential Information or Purchaser Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement.

Each Party will co-operate in all reasonable respects, in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to Applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by a reasoned opinion of its counsel is legally required, and such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.

(e) Nothing in this Section 10.1 shall be construed as preventing or in any way inhibiting any Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Governmental Authorities confidential or other information of the other Party.

Section 10.2 Notices. All notices, requests and other communications required or permitted under, or otherwise made in connection with, this Agreement, shall be in writing and shall be deemed to have been duly given (a) when delivered in person, (b) upon confirmation of receipt when transmitted by facsimile transmission, or (c) on the next Business Day if transmitted by national overnight courier (with confirmation of delivery), in each case, addressed as follows:

if to Seller, to:

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, CA 94005

Attention: General Counsel

Facsimile No.: (415) 466-2300

with a copy to (which shall not constitute notice):

Latham & Watkins LLP

140 Scott Drive

Menlo Park, CA 94025

Attention: Mark V. Roeder, Esq.

Facsimile No.: (650) 463-2600

if to Purchaser or Parent to:

Vidara Therapeutics International Limited

Attention: Dr. Virinder Nohria

c/o Fairisle Management Limited

The Penthouse, Washington Mall I

20 Church Street

Hamilton HM 11

Bermuda

Facsimile No.: (441) 295-4614

if to Opco to:

Vidara Therapeutics Research Limited

Adelaide Chambers

Peter Street

Dublin 8

Ireland

Attention: David Kelly

Facsimile No.: 353-1-449-3251

with a copy to (which shall not constitute notice):

Burke, Warren, MacKay & Serritella, P.C.

330 North Wabash Avenue, Suite 2200

Chicago, IL 60611

Attention: Christopher R. Manning

Facsimile No.: (312) 840-7900

or to such other address or facsimile number as such Party may hereafter specify for the purpose by notice to the other parties hereto in accordance with the terms of this Section 10.2.

Section 10.3 Bulk Transfers. Purchaser waives compliance with the provisions of all Applicable Laws relating to bulk transfers in connection with the transfer of the Purchased Assets.

Section 10.4 Remedies Cumulative; Specific Performance. The rights and remedies of the Parties shall be cumulative (and not alternative). The Parties agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically the performance of the terms and provisions of this Agreement in addition to any other remedy to which they are entitled to at law or in equity, in each case without the requirement of posting any bond or other type of security.

Section 10.5 Further Assurances; Further Cooperation. Subject to the terms and conditions hereof, each of the Parties agrees to use commercially reasonable efforts to execute and deliver, or cause to be executed and delivered, all documents and to take, or cause to be taken, all actions that may be reasonably necessary or appropriate, in the reasonable opinion of counsel for each Party, to effectuate the provisions of this Agreement, provided that all such actions are in accordance with Applicable Law. From time to time, whether at or after the Closing, (i) Seller shall execute and deliver such further documents or instruments of conveyance, transfer and assignment and take all such other action, at Purchaser’s sole expense, as Purchaser may reasonably require to more effectively convey, transfer and assign to Purchaser any and all ownership, right, title and interest in and to the Purchased Assets, including, without limitation, executing documents or instruments necessary to permit Purchaser to record the transfer, conveyance and/or assignment of any and all Product Intellectual Property with any

Governmental Authority and (ii) Purchaser, Parent and Opco will execute and deliver such further instruments and take all such other action, at Seller’s sole expense, as Seller may reasonably require to more effectively assume the Assumed Liabilities. Upon reasonable request and during normal business hours, Purchaser, Parent, Opco and Seller shall cooperate with each other, and shall cause their respective representatives and Affiliates to cooperate with each other, after the Closing to ensure the orderly transition of the Purchased Assets and Assumed Liabilities to Purchaser and to minimize any disruption to the businesses of Seller, Purchaser, Parent and Opco that might result from the transactions contemplated hereby.

Section 10.6 Amendments and Waivers.

(a) Any provision of this Agreement may be amended or waived but only if, such amendment or waiver is in writing and is signed, in the case of an amendment, by each Party to this Agreement or, in the case of a waiver, by the Party against whom the waiver is to be effective. No waiver by any Party hereto of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement or any future occasions.

(b) No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law.

Section 10.7 Expenses. Except as otherwise provided herein, all costs and expenses incurred in connection with this Agreement, including all third-party legal, accounting, financial advisory, consulting or other fees and expenses incurred in connection with the transactions contemplated hereby, shall be paid by the Party incurring such cost or expense.

Section 10.8 Binding Effect; Benefit; Assignment.

(a) The provisions of this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and assigns. Except as provided under this Agreement, no provision of this Agreement is intended to confer any rights, benefits, remedies, obligations or liabilities hereunder upon any Person other than the Parties and their respective successors and assigns.

(b) Neither this Agreement nor any right, interest or obligation hereunder may be assigned by any Party hereto (other than to an Affiliate of the Party) without the prior written consent of the other Party hereto (which consent shall not be unreasonably withheld) and any attempt to do so will be void; provided, however, that after the Closing, such prior written consent will not be required with respect to any assignment by any Party (a) to an Affiliate of such Party so long as such Party remains bound by the terms hereof, or (b) in connection with a reorganization, merger, statutory share exchange, consolidation or similar change of control transaction involving the Seller or sale or transfer of all or substantially all of the assets of Seller, or, in the case of Purchaser, a sale or transfer, regardless of form, involving all or substantially all of the assets associated with the Product Business. Except with respect to Section 8.14(a) of

this Agreement which shall not apply to non-affiliated successors or assigns of Seller, and except with respect to Section 8.14(b) of this Agreement which shall not apply to non-affiliated successors or assigns of Purchaser, Parent and Opco, this Agreement is binding upon, inures to the benefit of and is enforceable by the Parties hereto and their respective successors and permitted assigns. For the avoidance of doubt, all obligations pursuant to Section 8.14(a) shall automatically and immediately terminate and cease to be enforceable against any non-affiliated successor or assign of Seller and all obligations pursuant to Section 8.14(b) shall automatically and immediately terminate and cease to be enforceable against any non-affiliated successor of Parent, Purchaser or Opco. Any attempt to assign this Agreement in violation of this Section 10.8(b) shall be void. Subject to this Section 10.8(b), any permitted assignee shall assume all obligations of its assignor under this Agreement pursuant to a written instrument reasonably acceptable to the other Parties. In addition, nothing in this Agreement shall preclude Purchaser from providing its lenders with a security interest in its rights under this Agreement in accordance with the terms of their security and collateral agreements in connection with any credit facility provided by such lenders to Purchaser or preclude such lenders from foreclosing upon such security interest in accordance with the terms of such security and collateral agreements (including, without limitation, by means of the sale of the assets or stock of Purchaser to a Third Party including Purchaser’s rights and responsibilities under this Agreement), and any such action by such lenders shall not be deemed to be a change of control for purposes of this Agreement.

(c) Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person other than the Parties and their respective successors and permitted assigns any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

Section 10.9 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of laws that would require the application of the laws of any other jurisdiction.

Section 10.10 Jurisdiction. The Parties hereto agree that any Proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby shall be brought in any federal court located in the State of Delaware or any Delaware state court, and each of the Parties hereby irrevocably consents to the jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such Proceeding and irrevocably waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of the venue of any such Proceeding in any such court or that any such Proceeding brought in any such court has been brought in an inconvenient forum. Process in any such Proceeding may be served on any Party anywhere in the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing, each Party agrees that service of process on such party as provided in Section 10.2 shall be deemed effective service of process on such Party.

Section 10.11 Waiver of Jury Trial. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

Section 10.12 Arbitration.

(a) With respect to any dispute, controversy or claim arising from or related to this Agreement or the breach thereof that is not an Excluded Claim (“Dispute”), such Dispute shall first be referred to an executive officer from each Party for attempted resolution by good faith negotiations. Any such Dispute shall be submitted to such senior executives no later than thirty (30) days following such request by any Party. Such executives shall attempt in good faith to resolve any such Dispute within thirty (30) days after the submission of the Dispute. In the event the executives are unable to resolve the Dispute, the Parties shall otherwise negotiate in good faith and use reasonable efforts to settle. If the Parties do no fully settle, and a Party wishes to pursue the matter, each such Dispute shall be finally resolved by binding arbitration in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (“AAA”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof.

(b) The arbitration shall be conducted by a panel of three (3) persons experienced in the pharmaceutical business: within thirty (30) days after initiation of arbitration, each of Purchaser and Seller shall select one person to act as arbitrator and the two selected arbitrators shall select a third arbitrator within thirty (30) days of their appointment. If the arbitrators selected by Purchaser and Seller are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the AAA. The place of arbitration shall be San Francisco, California, and all proceedings and communications shall be in English.

(c) Any Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Any Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration.

(d) Except to the extent necessary to confirm an award or as may be required by law, no Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of each Party. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable Delaware statute of limitations.

(e) For clarity, this Section 10.12 shall not apply to any Excluded Claim with the result that Excluded Claims shall not be subject to resolution by arbitration in the absence of a separate agreement between the Parties to do so.

Section 10.13 Counterparts; Effectiveness. This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each Party shall have received a counterpart hereof signed by the other Party. Until and unless each Party has received a counterpart hereof signed by the other Party hereto,

this Agreement shall have no effect, and no Party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication). The exchange of a fully executed Agreement or any Ancillary Agreement (in counterparts or otherwise) by electronic transmission in .PDF format or by facsimile shall be sufficient to bind the Parties to the terms and conditions hereof and thereof.

Section 10.14 Entire Agreement. This Agreement, the Ancillary Agreements, the Confidentiality Agreement and each of the documents, instruments and agreements delivered in connection with the transactions contemplated by this Agreement, including each of the Exhibits, the Schedules, and the Seller Disclosure Schedule, constitute the entire agreement between the Parties with respect to the subject matter of this Agreement and supersede all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter of this Agreement.

Section 10.15 Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Governmental Authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party. Upon such a determination, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible.

Section 10.16 Time is of the Essence. Time is of the essence with respect to the performance of this Agreement.

(Signatures Pages Follow)

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Agreement Date.


VIDARA THERAPEUTICS INTERNATIONAL LIMITED

By:		/s/ Virinder Nohria
Name:		Virinder Nohria
Title:		President

VIDARA THERAPEUTICS HOLDINGS LLC
VIDARA THERAPEUTICS HOLDINGS LLC

By:		/s/ Bala Venkataraman
Name:		Bala Venkataraman
Title:		Chairman and Treasurer

VIDARA THERAPEUTICS RESEARCH LIMITED

By:		/s/ David G. Kelly
Name:		David G. Kelly
Title:		Director and Chief Financial Officer

Signature Page to Asset Purchase Agreement


INTERMUNE, INC.

By:		/s/ John C. Hodgman
Name:		John C. Hodgman
Title:		Chief Financial Officer and Senior Vice President, Finance

Signature Page to Asset Purchase Agreement

EX-2.1B 3 d370181dex21b.htm AMENDMENT TO ASSET PURCHASE AGREEMENT Amendment to Asset Purchase Agreement

Exhibit 2.1B

AMENDMENT TO ASSET PURCHASE AGREEMENT

This AMENDMENT TO ASSET PURCHASE AGREEMENT (the “Amendment”), dated as of June 18, 2012, is made and entered into by and among Vidara Therapeutics International Limited, an Irish company (“Purchaser”), Vidara Therapeutics Holdings LLC, a Delaware limited liability company (“Parent”), Vidara Therapeutics Research Limited, an Irish company (“Opco”) and InterMune, Inc., a Delaware corporation (“Seller”). Capitalized terms used herein and not otherwise defined herein shall have the meaning given such terms in the Agreement (as defined below).

RECITALS

WHEREAS, Purchaser, Parent, Opco and Seller entered into that certain Asset Purchase Agreement dated as of May 17, 2012 (the “Agreement”);

WHEREAS, due to a scrivener’s error, the attachment to Section 3.13(c) of the Seller Disclosure Schedule erroneously set forth the number of “Vials Sold Canada” and “Vials Sold US”;

WHEREAS, due to a scrivener’s error, Schedule 1.1(d) to the Agreement and Section 3.7 of the Seller Disclosure Schedule included an agreement which is not an Assumed Contract; and

WHEREAS, Purchaser, Parent, Opco and Seller desire to amend the Agreement as set forth herein.

AGREEMENT

Section 1.1 Amendments.

(a) The attachment to Section 3.13(c) of the Seller Disclosure Schedule is hereby amended and restated in its entirety as set forth in Exhibit A hereto.

(b) The following agreement is hereby deleted in its entirety from Schedule 1.1(d) to the Agreement and Section 3.7 of the Seller Disclosure Schedule: Second Amended and Restated Materials Transfer Agreement between National Jewish Health and InterMune, Inc. dated November 22, 2010.

Section 1.2 Miscellaneous Provisions.

(a) Article X of the Agreement shall apply hereto mutatis mutandis.

(Signature Pages Follow)

IN WITNESS WHEREOF, the Parties have caused the Amendment to be executed as of the first date written above.


VIDARA THERAPEUTICS INTERNATIONAL LIMITED

By:		/s/ Bala Venkataraman
Name:		Bala Venkataraman
Title:		Director

VIDARA THERAPEUTICS HOLDINGS LLC

By:		/s/ Virinder Nohria
Name:		Virinder Nohria
Title:		President

VIDARA THERAPEUTICS RESEARCH LIMITED

By:		/s/ David G. Kelly
Name:		David G. Kelly
Title:		Director and Chief Financial Officer

Signature Page to Amendment to Asset Purchase Agreement


INTERMUNE, INC.

By:		/s/ John C. Hodgman
Name:		John C. Hodgman
Title:		Chief Financial Officer and Senior Vice President, Finance

Signature Page to Amendment to Asset Purchase Agreement

EX-31.1 4 d370181dex311.htm CERTIFICATION REQUIRED BY RULE 13A-14(A) OR RULE 15D-14(A) Certification required by Rule 13a-14(a) or Rule 15d-14(a)

Exhibit 31.1

CERTIFICATIONS

I, Daniel G. Welch, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of InterMune, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 7, 2012

/s/ Daniel G. Welch

Daniel G. Welch

Chairman, Chief Executive Officer and President (principal executive officer)

EX-31.2 5 d370181dex312.htm CERTIFICATION REQUIRED BY RULE 13A-14(A) OR RULE 15D-14(A) Certification required by Rule 13a-14(a) or Rule 15d-14(a)

Exhibit 31.2

CERTIFICATIONS

I, John C. Hodgman, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of InterMune, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(a)

(b)

(c)

(d)

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 7, 2012

/s/ John C. Hodgman

John C. Hodgman

Chief Financial Officer and Senior Vice President, Finance

(principal financial officer)

EX-32.1 6 d370181dex321.htm CERTIFICATION REQUIRED BY RULE 13A-14(B) OR RULE 15D-14(B) Certification required by Rule 13a-14(b) or Rule 15d-14(b)

Exhibit 32.1

CERTIFICATION

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the Exchange Act) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Daniel G. Welch, Chief Executive Officer of InterMune, Inc. (the Company), and John C. Hodgman, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

1.	The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, to which this Certification is attached as Exhibit 32.1 (the Periodic Report), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.	The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

In Witness Whereof, the undersigned have set their hands hereto as of the 7th day of August, 2012.


/s/ Daniel G. Welch		/s/ John C. Hodgman
Daniel G. Welch		John C. Hodgman
Chief Executive Officer		Chief Financial Officer

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of InterMune, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

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ITMN INTERMUNE INC false Large Accelerated Filer Q2 2012 10-Q 2012-06-30 0001087432 --12-31

<div> Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or any other future period and should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC). </div>

104487000

-94069000

<div> Inventory valuation Inventories are stated at the lower of cost or market. Cost is determined by the specific identification method. Inventories were $9.2 million and $6.2 million at June 30, 2012 and December 31, 2011, respectively, and consisted solely of Esbriet at June 30, 2012. Because of the long lead times required to manufacture Esbriet, we enter into purchase obligations to satisfy our estimated inventory requirements. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current as well as committed purchases. We are also required to make judgments as to the expiration dates since the products are not usable beyond their expiration date. As part of our excess inventory assessment for Esbriet, we also consider the expiration dates of future manufactured quantities under these purchase obligations. We incurred approximately $0.2 million for inventory writedowns during the quarter ended June 30, 2012. As of June 30, 2012, we had firm commitments to purchase approximately $0.6 million of Esbriet inventory. </div>

<div> The following is a summary of our available-for-sale investments as of June 30, 2012 and December 31, 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="64%"></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Gains</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Losses</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> June 30, 2012 </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">151,442</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">18</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(32</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">151,428</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,931</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,934</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,168</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(3</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,223</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,567</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">79</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(35</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,611</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table>   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="64%"></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Gains</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Losses</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> December 31, 2011 </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">140,848</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">48</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(9</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">140,887</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,983</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,985</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,788</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">35</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(8</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,815</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Municipal bond </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">296,822</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">85</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(17</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">296,890</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

-1124000

-99465000

-45941000

1262000

1401000

9103000

747000

<div> Recent Accounting Pronouncements In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, Presentation of Comprehensive Income. This ASU gives an entity the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. We retrospectively adopted ASU No. 2011-05 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows. In May 2011, the FASB issued ASU No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This ASU is the result of joint efforts by the FASB and International Accounting Standards Board to develop a single, converged fair value framework. While this ASU is largely consistent with existing fair value measurement principles in U.S. GAAP, it expands ASC No. 820, Fair Value Measurement existing disclosure requirements for fair value measurements and makes other amendments. Many of these amendments were made to eliminate unnecessary wording differences between U.S. GAAP and International Financial Reporting Standards, which could change how fair value measurement guidance in ASC 820 is applied. We prospectively adopted ASU No. 2011-04 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows. </div>

145081000

-0.71

<div> Summary operating results for the discontinued operations are as follows (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Actimmune revenue, net </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">2,571</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">4,909</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">6,627</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">9,961</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Costs and expenses: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Cost of goods sold </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,448</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,359</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,474</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,645</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> General and administrative </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">86</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">97</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">160</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">302</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Total costs and expenses </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,534</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,456</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,634</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,947</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Income from discontinued operations </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">37</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">1,453</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">1,993</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">4,014</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> Gain on Sale of Discontinued Operations The gain on sale of discontinued operations is calculated as follows (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="68%" align="center"> <tr> <td width="87%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Cash proceeds received from sale </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right"> 55,000</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Less Actimmune assets sold: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Inventories, net </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(1,729</td> <td valign="bottom" nowrap="nowrap">) </td> </tr> <tr> <td valign="top"> Less direct transaction costs: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Legal and financial </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(1,936</td> <td valign="bottom" nowrap="nowrap">) </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Gain </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">51,335</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

<div> Revenue recognition and revenue reserves We recognize revenue from product sales generally upon delivery when title passes to a credit-worthy customer and record provisions for estimated returns, rebates, chargebacks and cash discounts against revenue. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.   Our European revenue from sales of Esbriet began in September 2011 and through June 30, 2012, has primarily been limited to revenue derived from sales in Germany. We only ship product upon receipt of valid orders from customers such as pharmacies and hospitals which are in turn a result of actual patient prescriptions. Pursuant to German Medicinal Products Law, a customer has no right to return the product; therefore we have not established a reserve for product returns, though we have established a reserve for the mandatory rebate as allowed under the applicable German health care regulations. Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned. In December 2010, we entered into a new agreement with Roche that focused on research to identify and develop next-generation protease inhibitors for the treatment of Hepatitis C virus. Under terms of the agreement, Roche funded all research costs related to the programs for the period from July 1, 2010 through June 30, 2011, the effective term of the research program. During 2011, we received $2.6 million from Roche as a reimbursement for research services performed which has been recorded as collaboration revenue. We will also be entitled to receive certain milestones and royalties in connection with the continued development and commercialization by Roche of any licensed compounds resulting from the research program. </div>

6627000

499000

<div> The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Cost of goods sold </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">54</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Research and development </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,135</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,008</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,440</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,100</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Selling, general and administrative </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,181</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,762</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">6,556</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,849</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total stock-based compensation expense </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">4,370</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">3,770</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">9,103</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">8,949</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

-85350000

41999000

304000

53328000

4634000

51335000

2270000

-42089000

4474000

-1878000

200000

<div> In accordance with portions of ASC Topic No. 820, the following table represents the Company’s fair value hierarchy for its financial assets (cash, cash equivalents and investments, including accrued interest of approximately $0.5 million and $0.7 million, respectively) measured at fair value on a recurring basis as of June 30, 2012 and December 31, 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="68%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom" nowrap="nowrap"> June 30, 2012 </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 1</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 2</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 3</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Total</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">151,428</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">151,428</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,223</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,223</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,934</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,934</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">239,585</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,611</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table>   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="68%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom" nowrap="nowrap"> December 31, 2011 </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 1</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 2</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Level 3</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Total</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">140,887</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">140,887</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,815</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,815</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,985</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,985</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Municipal bond </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">214,197</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">296,890</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

64858000

938000

219000

-99331000

<div> Revenue from customers representing 10% or more of total product revenue during the six month periods ended June 30, 2012 and 2011, was as follows:   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="76%" align="center"> <tr> <td width="88%"></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom" nowrap="nowrap"> Customer </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Phoenix Pharmahandel GmbH & Co. </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">25</td> <td valign="bottom" nowrap="nowrap">% </td> <td valign="bottom"> </td> <td valign="bottom" nowrap="nowrap"> </td> <td valign="bottom" nowrap="nowrap" align="right">—  </td> <td valign="bottom" nowrap="nowrap">% </td> </tr> </table> </div>

48378000

1262000

<div> The shares excluded were as follows (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="76%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Options </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,294</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,283</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Shares issuable upon conversion of convertible notes </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> </table> </div>

240345000

200000

<div> The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Denominator: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Weighted-average shares of common stock outstanding </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,468</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">59,889</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,357</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,660</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Less: weighted-average shares subject to repurchase </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(525</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(965</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(499</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(1,003</td> <td valign="bottom" nowrap="nowrap">) </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – basic </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,943</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Effect of dilutive securities (stock options, treasury stock method) </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">250</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – diluted </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,193</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

1993000

-1.53

64858000

4302000

4661000

<div> Principles of consolidation The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Holdings Ltd. and InterMune UK & I Ltd., along with our other subsidiaries located in Canada, the United Kingdom, Germany, France, Switzerland, Spain, Italy, the Netherlands, Sweden and Austria. All inter-company balances and transactions have been eliminated. </div>

<div> Research and development expenses Research and development (“R&D”) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations (“CRO”), licensing fees, acquired intellectual property with no alternative future use and facility and administrative expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2 and Phase 3 clinical trials. These costs are a significant component of our research and development expenses. We accrue costs for clinical trial activities performed by contract research organizations and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities using available information; however, if we underestimate activity levels associated with various studies at a given point in time, we could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. We charge all such costs to R&D expenses. Non-refundable advance payments are capitalized and expensed as the related goods are delivered or services are performed. </div>

290000

4183000

10418000

84533000

<div> Stock-Based Compensation The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Cost of goods sold </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">54</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Research and development </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,135</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,008</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,440</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,100</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Selling, general and administrative </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,181</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,762</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">6,556</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,849</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total stock-based compensation expense </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">4,370</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">3,770</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">9,103</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">8,949</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> Under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718-10, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the vesting period for that portion of the award that is ultimately expected to vest. In order to estimate the value of share-based awards, we use the Black-Scholes model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility, the expected term of the award and the estimated forfeiture rate. </div>

-46137000

51926000

<div> Foreign Currency Exchange Risk In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes. We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity. Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. Management does not expect material losses as a result of defaults by counterparties. </div>

134000

55000000

<div> <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="100%"> <tr> <td valign="top" width="4%" align="left">2.</td> <td valign="top" align="left">SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</td> </tr> </table> Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or any other future period and should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC). Principles of consolidation The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Holdings Ltd. and InterMune UK & I Ltd., along with our other subsidiaries located in Canada, the United Kingdom, Germany, France, Switzerland, Spain, Italy, the Netherlands, Sweden and Austria. All inter-company balances and transactions have been eliminated. Use of estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates and assumptions. We evaluate our estimates and assumptions on an ongoing basis, including those related to our allowances for doubtful accounts, product returns, chargebacks, cash discounts and rebates; excess/obsolete inventories; acquired product rights, the effects of inventory purchase commitments on inventory; certain accrued clinical and preclinical expenses and contingent liabilities and provision for income taxes. We base our estimates on historical experience and on various other specific assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.   Inventory valuation Inventories are stated at the lower of cost or market. Cost is determined by the specific identification method. Inventories were $9.2 million and $6.2 million at June 30, 2012 and December 31, 2011, respectively, and consisted solely of Esbriet at June 30, 2012. Because of the long lead times required to manufacture Esbriet, we enter into purchase obligations to satisfy our estimated inventory requirements. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current as well as committed purchases. We are also required to make judgments as to the expiration dates since the products are not usable beyond their expiration date. As part of our excess inventory assessment for Esbriet, we also consider the expiration dates of future manufactured quantities under these purchase obligations. We incurred approximately $0.2 million for inventory writedowns during the quarter ended June 30, 2012. As of June 30, 2012, we had firm commitments to purchase approximately $0.6 million of Esbriet inventory. Foreign Currency Exchange Risk In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes. We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity. Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. Management does not expect material losses as a result of defaults by counterparties. Acquired Product Rights Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA or the European Commission (“EC”) for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product, which we currently estimate to be 20 years for Esbriet. We assess this estimate regularly during the amortization period and adjust the asset value and/or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA or EC for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development costs. Revenue recognition and revenue reserves We recognize revenue from product sales generally upon delivery when title passes to a credit-worthy customer and record provisions for estimated returns, rebates, chargebacks and cash discounts against revenue. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.   Our European revenue from sales of Esbriet began in September 2011 and through June 30, 2012, has primarily been limited to revenue derived from sales in Germany. We only ship product upon receipt of valid orders from customers such as pharmacies and hospitals which are in turn a result of actual patient prescriptions. Pursuant to German Medicinal Products Law, a customer has no right to return the product; therefore we have not established a reserve for product returns, though we have established a reserve for the mandatory rebate as allowed under the applicable German health care regulations. Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned. In December 2010, we entered into a new agreement with Roche that focused on research to identify and develop next-generation protease inhibitors for the treatment of Hepatitis C virus. Under terms of the agreement, Roche funded all research costs related to the programs for the period from July 1, 2010 through June 30, 2011, the effective term of the research program. During 2011, we received $2.6 million from Roche as a reimbursement for research services performed which has been recorded as collaboration revenue. We will also be entitled to receive certain milestones and royalties in connection with the continued development and commercialization by Roche of any licensed compounds resulting from the research program. Research and development expenses Research and development (“R&D”) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations (“CRO”), licensing fees, acquired intellectual property with no alternative future use and facility and administrative expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2 and Phase 3 clinical trials. These costs are a significant component of our research and development expenses. We accrue costs for clinical trial activities performed by contract research organizations and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities using available information; however, if we underestimate activity levels associated with various studies at a given point in time, we could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. We charge all such costs to R&D expenses. Non-refundable advance payments are capitalized and expensed as the related goods are delivered or services are performed. Net income (loss) per share We compute basic net income (loss) per share by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period, as adjusted. We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net income per share by dividing the net income for the period by the weighted average number of common and potential common shares outstanding during the period. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method. For the computation of net loss per share we exclude dilutive securities, composed of potential common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, because of their anti-dilutive effect. The shares excluded were as follows (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="76%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Options </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,294</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,283</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Shares issuable upon conversion of convertible notes </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> </table>   The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Denominator: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Weighted-average shares of common stock outstanding </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,468</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">59,889</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,357</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,660</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Less: weighted-average shares subject to repurchase </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(525</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(965</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(499</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(1,003</td> <td valign="bottom" nowrap="nowrap">) </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – basic </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,943</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Effect of dilutive securities (stock options, treasury stock method) </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">250</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – diluted </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,193</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> Stock-Based Compensation The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Cost of goods sold </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">54</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Research and development </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,135</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,008</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,440</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,100</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Selling, general and administrative </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,181</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2,762</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">6,556</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,849</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total stock-based compensation expense </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">4,370</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">3,770</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">9,103</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">8,949</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> Under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718-10, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the vesting period for that portion of the award that is ultimately expected to vest. In order to estimate the value of share-based awards, we use the Black-Scholes model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility, the expected term of the award and the estimated forfeiture rate. Recent Accounting Pronouncements In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, Presentation of Comprehensive Income. This ASU gives an entity the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. We retrospectively adopted ASU No. 2011-05 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows. In May 2011, the FASB issued ASU No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This ASU is the result of joint efforts by the FASB and International Accounting Standards Board to develop a single, converged fair value framework. While this ASU is largely consistent with existing fair value measurement principles in U.S. GAAP, it expands ASC No. 820, Fair Value Measurement existing disclosure requirements for fair value measurements and makes other amendments. Many of these amendments were made to eliminate unnecessary wording differences between U.S. GAAP and International Financial Reporting Standards, which could change how fair value measurement guidance in ASC 820 is applied. We prospectively adopted ASU No. 2011-04 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows. </div>

<div> Use of estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates and assumptions. We evaluate our estimates and assumptions on an ongoing basis, including those related to our allowances for doubtful accounts, product returns, chargebacks, cash discounts and rebates; excess/obsolete inventories; acquired product rights, the effects of inventory purchase commitments on inventory; certain accrued clinical and preclinical expenses and contingent liabilities and provision for income taxes. We base our estimates on historical experience and on various other specific assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. </div>

1993000

<div> Net income (loss) per share We compute basic net income (loss) per share by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period, as adjusted. We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net income per share by dividing the net income for the period by the weighted average number of common and potential common shares outstanding during the period. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method. For the computation of net loss per share we exclude dilutive securities, composed of potential common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, because of their anti-dilutive effect. The shares excluded were as follows (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="76%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Options </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,294</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">5,283</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3,935</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Shares issuable upon conversion of convertible notes </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">9,384</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,502</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> </table>   The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="72%"></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="2%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Three Months Ended June 30,</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">Six Months Ended June 30,</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2012</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Denominator: </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Weighted-average shares of common stock outstanding </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,468</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">59,889</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,357</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,660</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Less: weighted-average shares subject to repurchase </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(525</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(965</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(499</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(1,003</td> <td valign="bottom" nowrap="nowrap">) </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – basic </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,943</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Effect of dilutive securities (stock options, treasury stock method) </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">250</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Weighted-average shares used in computing net income (loss) per share – diluted </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">65,193</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58,924</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">64,858</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">57,657</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div>

500000

4442000

-23000

160000 0.82 65357000 <div> The following table reflects our acquired product rights under these agreements (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="76%" align="center"> <tr> <td width="76%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">June 30, 2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">December 31, 2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Gross carrying amount </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">20,000</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">20,000</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Accumulated amortization </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,250</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">750</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Net carrying amount </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">18,750</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">19,250</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div> <div> The following is a summary of the amortized cost and estimated fair value of available-for-sale securities at June 30, 2012 by contractual maturity (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="76%" align="center"> <tr> <td width="78%"></td> <td valign="bottom" width="4%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="4%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">June 30, 2012</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Mature in less than one year </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">241,665</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">241,697</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Mature in one to three years </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">44,902</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">44,914</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Mature in over three years </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,567</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,611</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div> <div> <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="100%"> <tr> <td valign="top" width="4%" align="left">5.</td> <td valign="top" align="left">AVAILABLE-FOR-SALE INVESTMENTS</td> </tr> </table> The following is a summary of our available-for-sale investments as of June 30, 2012 and December 31, 2011 (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="64%"></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Gains</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Losses</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> June 30, 2012 </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">151,442</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">18</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(32</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">151,428</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">47,026</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,931</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">3</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">55,934</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,168</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">58</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(3</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">32,223</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,567</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">79</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(35</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,611</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table>   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="92%" align="center"> <tr> <td width="64%"></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="5%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Gains</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Gross Unrealized Losses</td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> December 31, 2011 </td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"> </td> <td valign="bottom"></td> <td valign="bottom"></td> <td valign="bottom"></td> </tr> <tr> <td valign="top"> Obligations of government-sponsored enterprises </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">140,848</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">48</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(9</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">140,887</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Money market funds </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">82,693</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Commercial paper </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,983</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">2</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">36,985</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Corporate debt securities </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,788</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">35</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">(8</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">31,815</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Municipal bond </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom"> </td> <td valign="bottom"> </td> <td valign="bottom" align="right">4,510</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">296,822</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">85</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">(17</td> <td valign="bottom" nowrap="nowrap">) </td> <td valign="bottom"> </td> <td valign="bottom">$</td> <td valign="bottom" align="right">296,890</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom"> </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table>   Realized gains and losses and declines in value, judged to be other than temporary, on available-for-sale securities are included in other income (expense) for the three- and six-months ended June 30, 2012 and 2011. Realized gains were calculated based on the specific identification method and were not material for each of the three- and six-month periods ended June 30, 2012 and June 30, 2011. Unrealized holding gains and losses on securities classified as available-for-sale are recorded in accumulated other comprehensive income. The following is a summary of the amortized cost and estimated fair value of available-for-sale securities at June 30, 2012 by contractual maturity (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="76%" align="center"> <tr> <td width="78%"></td> <td valign="bottom" width="4%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="4%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="6" align="center">June 30, 2012</td> <td valign="bottom"> </td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Amortized Cost</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">Fair Value</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Mature in less than one year </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">241,665</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">241,697</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Mature in one to three years </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">44,902</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">44,914</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Mature in over three years </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">—  </td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr> <td valign="top"> Total </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,567</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">286,611</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div> <div> Acquired Product Rights Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA or the European Commission (“EC”) for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product, which we currently estimate to be 20 years for Esbriet. We assess this estimate regularly during the amortization period and adjust the asset value and/or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA or EC for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development costs. </div> <div> <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="100%"> <tr> <td valign="top" width="4%" align="left">7.</td> <td valign="top" align="left">ACQUIRED PRODUCT RIGHTS</td> </tr> </table> Marnac, Inc./KDL GmbH (Pirfenidone) In 2002, we licensed from Marnac and its co-licensor, KDL, their worldwide rights (excluding Japan, Korea and Taiwan) to develop and commercialize pirfenidone for all fibrotic diseases, including renal, liver and pulmonary fibrosis. Under the agreement terms, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and up to 9% royalty payments. Effective November 2007, we entered into asset purchase agreements with Marnac and KDL whereby we effectively terminated the prior license agreement by purchasing, among other things, the pirfenidone-related assets covered by such prior license agreement. Under the terms of the asset purchase agreements, we made payments of approximately $13.7 million. We also made a milestone payment of $13.5 million in March 2009 in connection with our decision to proceed with regulatory approval for pirfenidone. In March 2011, we received authorization to market Esbriet (pirfenidone) in the European Union and made a milestone payment of $20.0 million in the aggregate to Marnac and KDL and have capitalized such payment as acquired product rights. This asset is being amortized to cost of goods sold over the estimated useful life of Esbriet of twenty years and we incurred approximately $0.5 million of amortization expense in the first six months of 2012. Amortization expense for each of the next five years is expected to be $1.0 million per year. A future contingent payment of up to an additional $20.0 million is required to be made by us only if positive Phase 3 data and product approval in the United States is achieved. The asset purchase agreements do not affect the rights to pirfenidone in Japan, Korea and Taiwan, which rights are licensed by Marnac and KDL to Shionogi & Company LTD (“Shionogi”). Since the original 2002 license agreement has been effectively terminated as a result of our acquisition of such pirfenidone-related assets from Marnac and KDL, we no longer have milestone or royalty obligations thereunder. The following table reflects our acquired product rights under these agreements (in thousands):   <table style="BORDER-COLLAPSE: collapse" border="0" cellspacing="0" cellpadding="0" width="76%" align="center"> <tr> <td width="76%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">June 30, 2012</td> <td valign="bottom"> </td> <td valign="bottom">  </td> <td style="BORDER-BOTTOM: #000000 1px solid" valign="bottom" colspan="2" align="center">December 31, 2011</td> <td valign="bottom"> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Gross carrying amount </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">20,000</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">20,000</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr> <td valign="top"> Accumulated amortization </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">1,250</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom"> </td> <td valign="bottom" align="right">750</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> <tr bgcolor="#CCEEFF"> <td valign="top"> Net carrying amount </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">18,750</td> <td valign="bottom" nowrap="nowrap">  </td> <td valign="bottom">  </td> <td valign="bottom">$</td> <td valign="bottom" align="right">19,250</td> <td valign="bottom" nowrap="nowrap">  </td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> <td valign="bottom">  </td> <td valign="bottom">   </td> <td valign="bottom">   </td> <td> </td> </tr> </table> </div> 11300000 32500000 32500000 20000000

107000

6556000

2440000

0.26

0.25

0.10

P20Y

10418000

Due 2015

600000

20000000

9384000

5283000

55000000

20000

55000000

P2Y

1936000

51335000

55000000

13500000 20000000

13700000

18800000

0.09

P20Y

2600000

0.12

0.10

Due 2018

41722000

-40393000

11000

-41347000

-39886000

3770000

-0.68

4909000

965000

121000

1453000

3456000

3359000

58924000

-20000

-41347000

20084000

1453000

-0.70

58924000

1329000

-39894000

21638000

1453000

1086000

28000

97000 0.02 59889000 1329000

2762000

1008000

4502000

3935000

54131000

-48593000

-139000

-50879000

430000

4370000

0.01

2571000

525000

159000

51372000

2534000

51335000

2448000

65193000

-33000

-50810000

25166000

37000

-0.78

64943000

250000

3323000

5538000

493000

25642000

69000

37000

2237000

-30000

86000 0.79 65468000

54000

3181000

1135000

5538000

9384000

3294000

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Disclosures About Segments of Enterprise and Related Information - Additional Information (Detail)	6 Months Ended	12 Months Ended
	Jun. 30, 2012 Customer	Dec. 31, 2011 Customer
Concentration Risk
Number of operating segment	1
Customer Concentration Risk
Concentration Risk
Concentration risk, percentage	10.00%	10.00%
Number of customers that represented more than 10% of accounts receivable	1	1
Customer Concentration Risk \| Customer 1 \| Trade Accounts Receivable
Concentration Risk
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Summary of Available for Sale Investments (Detail) (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Schedule of Available-for-sale Securities
Amortized Cost	$ 286,567	$ 296,822
Gross Unrealized Gains	79	85
Gross Unrealized Losses	(35)	(17)
Available-for-sale securities, Fair Value, Total	286,611	296,890
Obligations of government-sponsored enterprises
Schedule of Available-for-sale Securities
Amortized Cost	151,442	140,848
Gross Unrealized Gains	18	48
Gross Unrealized Losses	(32)	(9)
Available-for-sale securities, Fair Value, Total	151,428	140,887
Money market funds
Schedule of Available-for-sale Securities
Amortized Cost	47,026	82,693
Available-for-sale securities, Fair Value, Total	47,026	82,693
Commercial paper
Schedule of Available-for-sale Securities
Amortized Cost	55,931	36,983
Gross Unrealized Gains	3	2
Available-for-sale securities, Fair Value, Total	55,934	36,985
Corporate debt securities
Schedule of Available-for-sale Securities
Amortized Cost	32,168	31,788
Gross Unrealized Gains	58	35
Gross Unrealized Losses	(3)	(8)
Available-for-sale securities, Fair Value, Total	32,223	31,815
Municipal bond
Schedule of Available-for-sale Securities
Amortized Cost		4,510
Available-for-sale securities, Fair Value, Total		$ 4,510

- Definition

This item represents the cost of debt and equity securities, which are categorized neither as held-to-maturity nor trading, net of adjustments including accretion, amortization, collection of cash, previous other-than-temporary impairments recognized in earnings (less any cumulative-effect adjustments recognized, as defined), and fair value hedge accounting adjustments, if any.

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- Definition

This element represents the portion of the balance sheet assertion valued at fair value by the entity whether such amount is presented as a separate caption or as a parenthetical disclosure. Additionally, this element may be used in connection with the fair value disclosures required in the footnote disclosures to the financial statements. The element may be used in both the balance sheet and disclosure in the same submission. This item represents Available-for-sale Securities which consist of all investments in certain debt and equity securities neither classified as trading or held-to-maturity securities. A debt security represents a creditor relationship with an enterprise. Debt securities include, among other items, US Treasury securities, US government securities, municipal securities, corporate bonds, convertible debt, commercial paper, and all securitized debt instruments. An equity security represents an ownership interest in an enterprise or the right to acquire or dispose of an ownership interest in an enterprise at fixed or determinable prices. Equity securities include, among other things, common stock, certain preferred stock, warrant rights, call options, and put options, but do not include convertible debt. An entity may opt to provide the reader with additional narrative text to better understand the nature of investments in debt and equity securities which are categorized as Available-for-sale.

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- Definition

This item represents the gross unrealized gains for securities, at a point in time, which are categorized neither as held-to-maturity nor trading securities.

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Shares Excluded (Detail) In Thousands, unless otherwise specified	3 Months Ended		6 Months Ended
	Jun. 30, 2012	Jun. 30, 2011	Jun. 30, 2012	Jun. 30, 2011
Options
Antidilutive Securities Excluded from Computation of Earnings Per Share
Securities excluded from calculation of net loss per share	3,294	3,935	5,283	3,935
Shares issuable upon conversion of convertible notes
Antidilutive Securities Excluded from Computation of Earnings Per Share
Securities excluded from calculation of net loss per share	9,384	4,502	9,384	4,502

- Definition

Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.

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Acquired Product Rights (Detail) (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Acquired Finite-Lived Intangible Assets
Gross carrying amount	$ 20,000	$ 20,000
Accumulated amortization	1,250	750
Net carrying amount	$ 18,750	$ 19,250

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DISCONTINUED OPERATIONS
6 Months Ended

Jun. 30, 2012

DISCONTINUED OPERATIONS

3. DISCONTINUED OPERATIONS

On June 19, 2012, we completed the divestiture of our worldwide development and commercialization rights to the pharmaceutical product containing Interferon Gamma-1b sold by us under the tradename Actimmune^® for $55.0 million in cash, plus certain conditional royalty payments for a period of two years following the closing (the transaction is referred to herein as the “Asset Sale”). The Asset Sale was consummated pursuant to the terms of the Asset Purchase Agreement, dated as of May 17, 2012, by and among InterMune and Vidara Therapeutics International Limited, an Irish company, Vidara Therapeutics Holdings LLC, a Delaware limited liability company and Vidara Therapeutics Research Limited, an Irish company, as amended on June 18, 2012. The operating results of our Actimmune activities have been reclassified as discontinued operations for all periods presented.

Results of Discontinued Operations

Summary operating results for the discontinued operations are as follows (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Actimmune revenue, net
 $ 2,571 $ 4,909 $ 6,627 $ 9,961

Costs and expenses:


Cost of goods sold
 2,448 3,359 4,474 5,645

General and administrative
 86 97 160 302









Total costs and expenses
 2,534 3,456 4,634 5,947









Income from discontinued operations
 $ 37 $ 1,453 $ 1,993 $ 4,014









Gain on Sale of Discontinued Operations

The gain on sale of discontinued operations is calculated as follows (in thousands):

Cash proceeds received from sale
 $ 55,000

Less Actimmune assets sold:


Inventories, net
 (1,729 )

Less direct transaction costs:


Legal and financial
 (1,936 )



Gain
 $ 51,335

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Summary Operating Results for Discontinued Operations (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended

Jun. 30, 2012

Jun. 30, 2011

Jun. 30, 2012

Jun. 30, 2011

Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations

Actimmune revenue, net $ 2,571 $ 4,909 $ 6,627 $ 9,961

Costs and expenses:

Cost of goods sold 2,448 3,359 4,474 5,645

General and administrative 86 97 160 302

Total costs and expenses 2,534 3,456 4,634 5,947

Income from discontinued operations $ 37 $ 1,453 $ 1,993 $ 4,014

X

- Definition

Disposal Group, Including Discontinued Operation, General And Administrative Expense

+ References

No definition available.

+ Details

Name: itmn_DisposalGroupIncludingDiscontinuedOperationGeneralAndAdministrativeExpense

Namespace Prefix: itmn_

Data Type: xbrli:monetaryItemType

Balance Type: debit

Period Type: duration

X

- Details

Name: itmn_DisposalGroupIncludingDiscontinuedOperationOperatingExpenseAbstract

Namespace Prefix: itmn_

Data Type: xbrli:stringItemType

Balance Type: na

Period Type: duration

X

- Definition

Amount of costs of goods sold attributable to the disposal group, including a component of the entity (discontinued operation), during the reporting period.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher FASB

-Name Accounting Standards Codification

-Topic 205

-SubTopic 20

-Section 50

-Paragraph 1

-Subparagraph (c)

-URI http://asc.fasb.org/extlink&oid=6360339&loc=d3e1361-107760

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended

Jun. 30, 2012

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or any other future period and should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC).

Principles of consolidation

The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Holdings Ltd. and InterMune UK & I Ltd., along with our other subsidiaries located in Canada, the United Kingdom, Germany, France, Switzerland, Spain, Italy, the Netherlands, Sweden and Austria. All inter-company balances and transactions have been eliminated.

Use of estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates and assumptions.

We evaluate our estimates and assumptions on an ongoing basis, including those related to our allowances for doubtful accounts, product returns, chargebacks, cash discounts and rebates; excess/obsolete inventories; acquired product rights, the effects of inventory purchase commitments on inventory; certain accrued clinical and preclinical expenses and contingent liabilities and provision for income taxes. We base our estimates on historical experience and on various other specific assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Inventory valuation

Inventories are stated at the lower of cost or market. Cost is determined by the specific identification method. Inventories were $9.2 million and $6.2 million at June 30, 2012 and December 31, 2011, respectively, and consisted solely of Esbriet at June 30, 2012.

Because of the long lead times required to manufacture Esbriet, we enter into purchase obligations to satisfy our estimated inventory requirements. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current as well as committed purchases. We are also required to make judgments as to the expiration dates since the products are not usable beyond their expiration date. As part of our excess inventory assessment for Esbriet, we also consider the expiration dates of future manufactured quantities under these purchase obligations.

We incurred approximately $0.2 million for inventory writedowns during the quarter ended June 30, 2012. As of June 30, 2012, we had firm commitments to purchase approximately $0.6 million of Esbriet inventory.

Foreign Currency Exchange Risk

In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes.

We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity.

Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. Management does not expect material losses as a result of defaults by counterparties.

Acquired Product Rights

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA or the European Commission (“EC”) for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product, which we currently estimate to be 20 years for Esbriet. We assess this estimate regularly during the amortization period and adjust the asset value and/or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA or EC for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development costs.

Revenue recognition and revenue reserves

We recognize revenue from product sales generally upon delivery when title passes to a credit-worthy customer and record provisions for estimated returns, rebates, chargebacks and cash discounts against revenue. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.

Our European revenue from sales of Esbriet began in September 2011 and through June 30, 2012, has primarily been limited to revenue derived from sales in Germany. We only ship product upon receipt of valid orders from customers such as pharmacies and hospitals which are in turn a result of actual patient prescriptions. Pursuant to German Medicinal Products Law, a customer has no right to return the product; therefore we have not established a reserve for product returns, though we have established a reserve for the mandatory rebate as allowed under the applicable German health care regulations.

Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

In December 2010, we entered into a new agreement with Roche that focused on research to identify and develop next-generation protease inhibitors for the treatment of Hepatitis C virus. Under terms of the agreement, Roche funded all research costs related to the programs for the period from July 1, 2010 through June 30, 2011, the effective term of the research program. During 2011, we received $2.6 million from Roche as a reimbursement for research services performed which has been recorded as collaboration revenue. We will also be entitled to receive certain milestones and royalties in connection with the continued development and commercialization by Roche of any licensed compounds resulting from the research program.

Research and development expenses

Research and development (“R&D”) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations (“CRO”), licensing fees, acquired intellectual property with no alternative future use and facility and administrative expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2 and Phase 3 clinical trials. These costs are a significant component of our research and development expenses.

We accrue costs for clinical trial activities performed by contract research organizations and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities using available information; however, if we underestimate activity levels associated with various studies at a given point in time, we could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. We charge all such costs to R&D expenses. Non-refundable advance payments are capitalized and expensed as the related goods are delivered or services are performed.

Net income (loss) per share

We compute basic net income (loss) per share by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period, as adjusted. We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net income per share by dividing the net income for the period by the weighted average number of common and potential common shares outstanding during the period. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method. For the computation of net loss per share we exclude dilutive securities, composed of potential common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, because of their anti-dilutive effect.

The shares excluded were as follows (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Options
 3,294 3,935 5,283 3,935

Shares issuable upon conversion of convertible notes
 9,384 4,502 9,384 4,502

The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Denominator:


Weighted-average shares of common stock outstanding
 65,468 59,889 65,357 58,660

Less: weighted-average shares subject to repurchase
 (525 ) (965 ) (499 ) (1,003 )



Weighted-average shares used in computing net income (loss) per share – basic
 64,943 58,924 64,858 57,657



Effect of dilutive securities (stock options, treasury stock method)
 250 — — —



Weighted-average shares used in computing net income (loss) per share – diluted
 65,193 58,924 64,858 57,657



Stock-Based Compensation

The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Cost of goods sold
 $ 54 $ — $ 107 $ —

Research and development
 1,135 1,008 2,440 3,100

Selling, general and administrative
 3,181 2,762 6,556 5,849









Total stock-based compensation expense
 $ 4,370 $ 3,770 $ 9,103 $ 8,949









Under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718-10, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the vesting period for that portion of the award that is ultimately expected to vest. In order to estimate the value of share-based awards, we use the Black-Scholes model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility, the expected term of the award and the estimated forfeiture rate.

Recent Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, Presentation of Comprehensive Income. This ASU gives an entity the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. We retrospectively adopted ASU No. 2011-05 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

In May 2011, the FASB issued ASU No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This ASU is the result of joint efforts by the FASB and International Accounting Standards Board to develop a single, converged fair value framework. While this ASU is largely consistent with existing fair value measurement principles in U.S. GAAP, it expands ASC No. 820, Fair Value Measurement existing disclosure requirements for fair value measurements and makes other amendments. Many of these amendments were made to eliminate unnecessary wording differences between U.S. GAAP and International Financial Reporting Standards, which could change how fair value measurement guidance in ASC 820 is applied. We prospectively adopted ASU No. 2011-04 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

X

- Definition

The entire disclosure for all significant accounting policies of the reporting entity.

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Financial Assets Measured at Fair Value on Recurring Basis (Detail) (USD $)
In Thousands, unless otherwise specified

Jun. 30, 2012

Dec. 31, 2011

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities $ 286,611 $ 296,890

Money market funds

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 47,026 82,693

Obligations of government-sponsored enterprises

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 151,428 140,887

Corporate debt securities

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 32,223 31,815

Commercial paper

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 55,934 36,985

Municipal bond

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 4,510

Fair Value, Inputs, Level 1

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 47,026 82,693

Fair Value, Inputs, Level 1 | Money market funds

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 47,026 82,693

Fair Value, Inputs, Level 2

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 239,585 214,197

Fair Value, Inputs, Level 2 | Obligations of government-sponsored enterprises

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 151,428 140,887

Fair Value, Inputs, Level 2 | Corporate debt securities

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 32,223 31,815

Fair Value, Inputs, Level 2 | Commercial paper

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities 55,934 36,985

Fair Value, Inputs, Level 2 | Municipal bond

Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis

Available-for-sale securities $ 4,510

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Revenue from Customers Representing Ten Percentage or More of Total Product Revenue (Detail) (Phoenix Pharmahandel Gmbh and Co)
6 Months Ended

Jun. 30, 2012

Phoenix Pharmahandel Gmbh and Co

Revenue, Major Customer

Percentage of total product revenue 25.00%

X

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CONDENSED CONSOLIDATED BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified

Jun. 30, 2012

Dec. 31, 2011

Current assets:

Cash and cash equivalents $ 135,339 $ 177,428

Available-for-sale securities 258,390 247,682

Accounts receivable, net of allowances of $20 and $56 at June 30, 2012 and December 31, 2011, respectively 4,702 3,764

Inventories 9,152 6,220

Prepaid expenses and other current assets 6,064 8,044

Total current assets 413,647 443,138

Property and equipment, net 4,118 2,341

Acquired product rights 18,750 19,250

Other assets (includes restricted cash of $1,674 at June 30, 2012 and $1,427 at December 31, 2011) 7,588 7,894

Total assets 444,103 472,623

Current liabilities:

Accounts payable 12,282 10,068

Accrued compensation 7,577 9,044

Other accrued liabilities 21,217 14,979

Total current liabilities 41,076 34,091

Convertible notes 240,250 240,250

Other long term liabilities 185 114

Commitments and contingencies

Stockholders' equity:

Common stock 66 65

Additional paid-in capital 1,155,311 1,144,947

Accumulated other comprehensive income 1,221 1,025

Accumulated deficit (994,006) (947,869)

Total stockholders' equity 162,592 198,168

Total liabilities and stockholders' equity $ 444,103 $ 472,623

X

- Definition

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by regulatory authorities for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product.

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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)
In Thousands, unless otherwise specified
6 Months Ended

Jun. 30, 2012

Jun. 30, 2011

Cash flows used in operating activities:

Net loss $ (46,137) $ (71,997)

Adjustments to reconcile net loss to net cash used in operating activities:

Gain on sale of discontinued operations (51,335)

Amortization and depreciation 1,401 1,727

Stock-based compensation expense 9,103 8,949

Net realized gains on sales of available for sale securities (15)

Other 290 (260)

Changes in operating assets and liabilities:

Accounts receivable, net (938) 42

Inventories (4,661) (3,790)

Other assets 1,878 (1,878)

Accounts payable and accrued compensation 747 3,541

Other accrued liabilities 4,302 1,344

Net cash used in operating activities (85,350) (62,337)

Cash flows from investing activities:

Proceeds from the divestiture of Actimmune 55,000

Acquisition of product rights (20,000)

Purchases of property and equipment (2,270) (321)

Purchases of available-for-sale securities (240,345) (143,246)

Sales of available-for-sale securities 84,533 37,937

Maturities of available-for-sale securities 145,081 106,684

Net cash provided by (used in) investing activities 41,999 (18,946)

Cash flows from financing activities:

Proceeds from issuance of common stock under employee stock benefit plans 1,262 33,194

Net cash provided by financing activities 1,262 33,194

Net decrease in cash and cash equivalents (42,089) (48,089)

Cash and cash equivalents at beginning of period 177,428 110,584

Cash and cash equivalents at end of period 135,339 62,495

Non-cash financing activities:

Issuance of common stock in exchange for convertible debt $ 44,963

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ORGANIZATION
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Jun. 30, 2012

ORGANIZATION

1. ORGANIZATION

Overview

We are a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. Pulmonology is the field of medicine concerned with the diagnosis and treatment of lung conditions. We have an advanced-stage product candidate in pulmonology, pirfenidone, that was granted marketing authorization effective February 2011 in all 27 member countries of the European Union (“EU”) for the treatment of adults with mild to moderate idiopathic pulmonary fibrosis (“IPF”). In September 2011, we launched commercial sales of pirfenidone in Germany under the trade name Esbriet^®, and we are continuing to prepare for the commercial launch of Esbriet^® in the other countries in the EU. We are also pursuing the registration of pirfenidone to treat IPF in the United States. After reviewing various regulatory and clinical development options and following our discussions with the United States Food and Drug Administration (“FDA”), we commenced an additional pivotal Phase 3 clinical study of pirfenidone in IPF in July 2011, known as the ASCEND trial, which is expected to be fully enrolled around the end of 2012 with results in the first half of 2014. The results of the ASCEND trial are expected to supplement the existing Phase 3 clinical study data from our CAPACITY clinical trials to support the registration of pirfenidone to treat IPF in the United States.

On June 19, 2012, we completed the divestiture of our worldwide development and commercialization rights to the pharmaceutical product containing Interferon Gamma-1b sold by us under the tradename Actimmune^® for $55.0 million in cash, plus certain conditional royalty payments for a period of two years following the closing. The operating results of our Actimmune activities have been reclassified as discontinued operations for all periods presented.

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CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
In Thousands, unless otherwise specified

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Dec. 31, 2011

Accounts receivable, allowances $ 20 $ 56

Other assets, restricted cash $ 1,674 $ 1,427

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended

Jun. 30, 2012

Shares Excluded

The shares excluded were as follows (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Options
 3,294 3,935 5,283 3,935

Shares issuable upon conversion of convertible notes
 9,384 4,502 9,384 4,502

Reconciliation of Denominator used in Calculation of Basic and Diluted Net Income Loss Per Share Attributable to Common Stockholders

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 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Denominator:


Weighted-average shares of common stock outstanding
 65,468 59,889 65,357 58,660

Less: weighted-average shares subject to repurchase
 (525 ) (965 ) (499 ) (1,003 )



Weighted-average shares used in computing net income (loss) per share – basic
 64,943 58,924 64,858 57,657



Effect of dilutive securities (stock options, treasury stock method)
 250 — — —



Weighted-average shares used in computing net income (loss) per share – diluted
 65,193 58,924 64,858 57,657



Stock-Based Compensation Expense Recognized

The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Cost of goods sold
 $ 54 $ — $ 107 $ —

Research and development
 1,135 1,008 2,440 3,100

Selling, general and administrative
 3,181 2,762 6,556 5,849









Total stock-based compensation expense
 $ 4,370 $ 3,770 $ 9,103 $ 8,949









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XML 39 R18.htm IDEA: XBRL DOCUMENT v2.4.0.6

DISCONTINUED OPERATIONS (Tables)
6 Months Ended

Jun. 30, 2012

Operating Results and Gain on Sale of Discontinued Operations

Summary operating results for the discontinued operations are as follows (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Actimmune revenue, net
 $ 2,571 $ 4,909 $ 6,627 $ 9,961

Costs and expenses:


Cost of goods sold
 2,448 3,359 4,474 5,645

General and administrative
 86 97 160 302









Total costs and expenses
 2,534 3,456 4,634 5,947









Income from discontinued operations
 $ 37 $ 1,453 $ 1,993 $ 4,014









Gain on Sale of Discontinued Operations

The gain on sale of discontinued operations is calculated as follows (in thousands):

Cash proceeds received from sale
 $ 55,000

Less Actimmune assets sold:


Inventories, net
 (1,729 )

Less direct transaction costs:


Legal and financial
 (1,936 )



Gain
 $ 51,335



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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 6 Months Ended

Jun. 30, 2012

Jun. 30, 2011

Jun. 30, 2012

Jun. 30, 2011

Revenue, net

Collaboration revenue $ 1,329 $ 2,629

Total revenue, net 5,538 1,329 10,418 2,629

Costs and expenses:

Cost of goods sold 3,323 4,183

Research and development 25,166 20,084 48,378 36,922

Selling, general and administrative 25,642 21,638 51,926 39,009

Total costs and expenses 54,131 41,722 104,487 75,931

Loss from operations (48,593) (40,393) (94,069) (73,302)

Other income (expense):

Interest income 159 121 304 259

Interest expense (2,237) (1,086) (4,442) (2,873)

Other income (expense) (139) 11 (1,124) (95)

Loss from operations before income taxes (50,810) (41,347) (99,331) (76,011)

Income tax expense 69 134

Loss from continuing operations (50,879) (41,347) (99,465) (76,011)

Discontinued operations:

Income from discontinued operations 37 1,453 1,993 4,014

Gain on sale of discontinued operations 51,335 51,335

Income from discontinued operations 51,372 1,453 53,328 4,014

Net income (loss) 493 (39,894) (46,137) (71,997)

Basic and diluted net income (loss) per common share:

Continuing operations $ (0.78) $ (0.70) $ (1.53) $ (1.32)

Discontinued operations $ 0.79 $ 0.02 $ 0.82 $ 0.07

Earnings Per Share, Basic and Diluted, Total $ 0.01 $ (0.68) $ (0.71) $ (1.25)

Shares used in computing basic net income (loss) per share 64,943 58,924 64,858 57,657

Shares used in computing diluted net income (loss) per share 65,193 58,924 64,858 57,657

Esbriet

Revenue, net

Sales revenue, net $ 5,538 $ 10,418

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DERIVATIVE INSTRUMENTS
6 Months Ended

Jun. 30, 2012

DERIVATIVE INSTRUMENTS

6. DERIVATIVE INSTRUMENTS

In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes. In the fourth quarter of 2011, the Company established a foreign currency hedging program.

We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity. Our net gains from entering into derivative financial instruments not designated as hedges in the first six months of 2012 was approximately $0.2 million. The notional value of our outstanding currency hedges at June 30, 2012 was approximately 13.0 million euros and the fair value of these outstanding derivatives at June 30, 2012 was zero.

Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. We do not generally require collateral to be pledged under these agreements. Management does not expect material losses as a result of defaults by counterparties.

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AVAILABLE-FOR-SALE INVESTMENTS
6 Months Ended

Jun. 30, 2012

AVAILABLE-FOR-SALE INVESTMENTS

5. AVAILABLE-FOR-SALE INVESTMENTS

The following is a summary of our available-for-sale investments as of June 30, 2012 and December 31, 2011 (in thousands):

 Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value

June 30, 2012


Obligations of government-sponsored enterprises
 $ 151,442 $ 18 $ (32 ) $ 151,428

Money market funds
 47,026 — — 47,026

Commercial paper
 55,931 3 — 55,934

Corporate debt securities
 32,168 58 (3 ) 32,223







Total
 $ 286,567 $ 79 $ (35 ) $ 286,611







 Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value

December 31, 2011


Obligations of government-sponsored enterprises
 $ 140,848 $ 48 $ (9 ) $ 140,887

Money market funds
 82,693 — — 82,693

Commercial paper
 36,983 2 — 36,985

Corporate debt securities
 31,788 35 (8 ) 31,815

Municipal bond
 4,510 — — 4,510







Total
 $ 296,822 $ 85 $ (17 ) $ 296,890







Realized gains and losses and declines in value, judged to be other than temporary, on available-for-sale securities are included in other income (expense) for the three- and six-months ended June 30, 2012 and 2011. Realized gains were calculated based on the specific identification method and were not material for each of the three- and six-month periods ended June 30, 2012 and June 30, 2011. Unrealized holding gains and losses on securities classified as available-for-sale are recorded in accumulated other comprehensive income.

The following is a summary of the amortized cost and estimated fair value of available-for-sale securities at June 30, 2012 by contractual maturity (in thousands):

 June 30, 2012

 Amortized
Cost Fair Value

Mature in less than one year
 $ 241,665 $ 241,697

Mature in one to three years
 44,902 44,914

Mature in over three years
 — —





Total
 $ 286,567 $ 286,611





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Organization - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified
1 Months Ended 6 Months Ended

Jun. 30, 2012

Jun. 19, 2012

Organization and Nature of Operations [Line Items]

Cash proceeds received from sale $ 55,000 $ 55,000

European Union | Marketing Authorization

Organization and Nature of Operations [Line Items]

Number of member countries of the European Union ("EU") in which marketing authorization is granted 27

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-Publisher FASB

-Name Accounting Standards Codification

-Glossary Investing Activities

-URI http://asc.fasb.org/extlink&oid=6516133

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-Name Accounting Standards Codification

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-SubTopic 10

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-Subparagraph (b)

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-Paragraph 15, 16

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FAIR VALUE (Tables)
6 Months Ended

Jun. 30, 2012

Financial Assets Measured At Fair Value On A Recurring Basis

In accordance with portions of ASC Topic No. 820, the following table represents the Company’s fair value hierarchy for its financial assets (cash, cash equivalents and investments, including accrued interest of approximately $0.5 million and $0.7 million, respectively) measured at fair value on a recurring basis as of June 30, 2012 and December 31, 2011 (in thousands):

June 30, 2012
 Level 1 Level 2 Level 3 Total

Money market funds
 $ 47,026 $ — $ — $ 47,026

Obligations of government-sponsored enterprises
 — 151,428 — 151,428

Corporate debt securities
 — 32,223 — 32,223

Commercial paper
 — 55,934 — 55,934









Total
 $ 47,026 $ 239,585 $ — $ 286,611









December 31, 2011
 Level 1 Level 2 Level 3 Total

Money market funds
 $ 82,693 $ — $ — $ 82,693

Obligations of government-sponsored enterprises
 — 140,887 — 140,887

Corporate debt securities
 — 31,815 — 31,815

Commercial paper
 — 36,985 — 36,985

Municipal bond
 — 4,510 — 4,510









Total
 $ 82,693 $ 214,197 $ — $ 296,890









X

- Definition

Tabular disclosure of assets, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, by class that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3).

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DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION
6 Months Ended

Jun. 30, 2012

DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION

9. DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION

We have determined that, in accordance with ASC Topic No. 280, we operate in one segment, because operating results are reported only on an aggregate basis to our chief operating decision makers. We currently market and sell Esbriet in Europe for the treatment of IPF, of which substantially all revenue is derived from Germany since the initial launch in September 2011. Revenue from sales of Actimmune has been reclassified to discontinued operations for all periods presented and therefore is not included in the figures below. See also note 3.

Our revenue and trade receivables are concentrated with a few customers. We perform credit evaluations on our customers’ financial condition and limit the amount of credit extended. However, we generally do not require collateral on accounts receivable. Concentrations of credit risk, with respect to accounts receivable, exist to the extent of amounts presented in the financial statements. One customer represented approximately 26% and 12% of total trade accounts receivable at June 30, 2012 and December 31, 2011, respectively. No other customer represented more than 10% of accounts receivable at June 30, 2012 or December 31, 2011.

Revenue from customers representing 10% or more of total product revenue during the six month periods ended June 30, 2012 and 2011, was as follows:

 Six Months
Ended
June 30,

Customer
 2012 2011

Phoenix Pharmahandel GmbH & Co.
 25 % — %

X

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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ACQUIRED PRODUCT RIGHTS
6 Months Ended

Jun. 30, 2012

ACQUIRED PRODUCT RIGHTS

7. ACQUIRED PRODUCT RIGHTS

Marnac, Inc./KDL GmbH (Pirfenidone)

In 2002, we licensed from Marnac and its co-licensor, KDL, their worldwide rights (excluding Japan, Korea and Taiwan) to develop and commercialize pirfenidone for all fibrotic diseases, including renal, liver and pulmonary fibrosis. Under the agreement terms, we received an exclusive license from Marnac and KDL in exchange for an up-front cash payment of $18.8 million and future milestone and up to 9% royalty payments. Effective November 2007, we entered into asset purchase agreements with Marnac and KDL whereby we effectively terminated the prior license agreement by purchasing, among other things, the pirfenidone-related assets covered by such prior license agreement. Under the terms of the asset purchase agreements, we made payments of approximately $13.7 million. We also made a milestone payment of $13.5 million in March 2009 in connection with our decision to proceed with regulatory approval for pirfenidone. In March 2011, we received authorization to market Esbriet (pirfenidone) in the European Union and made a milestone payment of $20.0 million in the aggregate to Marnac and KDL and have capitalized such payment as acquired product rights. This asset is being amortized to cost of goods sold over the estimated useful life of Esbriet of twenty years and we incurred approximately $0.5 million of amortization expense in the first six months of 2012. Amortization expense for each of the next five years is expected to be $1.0 million per year. A future contingent payment of up to an additional $20.0 million is required to be made by us only if positive Phase 3 data and product approval in the United States is achieved. The asset purchase agreements do not affect the rights to pirfenidone in Japan, Korea and Taiwan, which rights are licensed by Marnac and KDL to Shionogi & Company LTD (“Shionogi”). Since the original 2002 license agreement has been effectively terminated as a result of our acquisition of such pirfenidone-related assets from Marnac and KDL, we no longer have milestone or royalty obligations thereunder.

The following table reflects our acquired product rights under these agreements (in thousands):

 June 30,
2012 December 31,
2011

Gross carrying amount
 $ 20,000 $ 20,000

Accumulated amortization
 1,250 750





Net carrying amount
 $ 18,750 $ 19,250





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COMMITMENTS AND CONTINGENCIES
6 Months Ended

Jun. 30, 2012

COMMITMENTS AND CONTINGENCIES

8. COMMITMENTS AND CONTINGENCIES

Contingent Payments

We may be required to make contingent milestone payments to the owners of our licensed products or the suppliers of our drug compounds in accordance with our license, commercialization and collaboration agreements in the aggregate amount of $32.5 million if all of the milestones per the agreements are achieved. These milestones include development, regulatory approval, commercialization and sales milestones. Of the remaining $32.5 million in future aggregate milestone payments, $20.0 million in contingent payments would be made by us only if positive Phase 3 data and product approval in the United States is achieved for pirfenidone. Included in the $32.5 million in future aggregate milestone payments are aggregate milestone payments of $11.3 million payable to Array and Novartis, of which Roche has agreed to reimburse us in connection with our sale of danoprevir to Roche.

Indemnity Agreement

On or about March 22, 2000, we entered into an Indemnity Agreement with W. Scott Harkonen M.D., who served as the Company’s chief executive officer until June 30, 2003. The Indemnity Agreement obligates us to hold harmless and indemnify Dr. Harkonen against expenses (including attorneys’ fees), witness fees, damages, judgments, fines and amounts paid in settlement and any other amounts Dr. Harkonen becomes legally obligated to pay because of any claim or claims made against him in connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal, arbitrational, administrative or investigative, to which Dr. Harkonen is a party by reason of the fact that he was a director, officer, employee or other agent of the Company. The Indemnity Agreement establishes exceptions to our indemnification obligation, including but not limited to claims “on account of [Dr. Harkonen’s] conduct that is established by a final judgment as knowingly fraudulent or deliberately dishonest or that constituted willful misconduct,” claims “on account of [Dr. Harkonen’s] conduct that is established by a final judgment as constituting a breach of [Dr. Harkonen’s] duty of loyalty to the Corporation or resulting in any personal profit or advantage to which [Dr. Harkonen] was not legally entitled,” and claims “for which payment is actually made to [Dr. Harkonen] under a valid and collectible insurance policy.” The Indemnity Agreement, however, obligates us to advance all expenses, including attorneys’ fees, incurred by Dr. Harkonen in connection with such proceedings, subject to an undertaking by Dr. Harkonen to repay said amounts if it shall be determined ultimately that he is not entitled to be indemnified by the Company.

Dr. Harkonen was named as a defendant in certain civil action lawsuits instituted against us where the various complaints that were filed alleged that we fraudulently misrepresented the medical benefits of Actimmune for the treatment of IPF and promoted Actimmune for IPF. Ultimately, these complaints were dismissed. However, Dr. Harkonen also became the target of the investigation by the U.S. Department of Justice regarding the promotion and marketing of Actimmune. On March 18, 2008, a federal grand jury indicted Dr. Harkonen on two felony counts related to alleged improper promotion and marketing of Actimmune during the time Dr. Harkonen was employed by us (the “Criminal Action”). The trial in the criminal case resulted in a jury verdict on September 29, 2009, finding Dr. Harkonen guilty of one count of wire fraud related to a press release issued on August 28, 2002, and acquitting him of a second count of a misbranding charge brought under the Federal Food, Drug, and Cosmetic Act. On April 13, 2011, the Court denied Dr. Harkonen’s post-trial motions and sentenced Dr. Harkonen to three years of probation, including six months of home detention, 200 hours of community service and a fine of $20,000. The Court’s Judgment was filed on April 18, 2011. Dr. Harkonen filed a timely notice of appeal and currently is appealing his conviction and sentence. The government has indicated that it will pursue a cross-appeal regarding Dr. Harkonen’s sentence. Briefing is underway. Under the terms of the Indemnity Agreement, we have an obligation to indemnify Dr. Harkonen for reasonable legal fees and costs incurred in connection with defending this action, including the proceedings on appeal.

Prior to December 2008, insurers that issued directors & officers (“D&O”) liability insurance to the Company had advanced all of Dr. Harkonen’s expenses, including attorneys’ fees, incurred in the civil action lawsuits and Criminal Action. Those insurers included National Union Fire Insurance Company of Pittsburgh, PA (“AIG”), Underwriters at Lloyd’s, London (“Lloyd’s”), and Continental Casualty Company (“CNA”). On November 19, 2008, however, the insurer that issued a $5 million D&O insurance policy providing coverage excess of the monetary limits of coverage provided by AIG, Lloyd’s and CNA, Arch Specialty Insurance Company (“Arch”), advised the Company that the limits of the underlying coverage were expected to be depleted by approximately December 15, 2008; that Arch “disclaim[ed] coverage” based on misstatements and misrepresentations allegedly made by Dr. Harkonen in documents provided in the application for the Arch policy and the underlying Lloyd’s policy; and that, based on that disclaimer, Arch would not be advancing any of Dr. Harkonen’s expenses, including attorneys’ fees, incurred in the civil action lawsuits and Criminal Action.

As a result of Arch’s disclaimer of coverage and refusal to advance expenses, including attorneys’ fees, the Company had, as of approximately December 15, 2008, become obligated to advance such expenses incurred by Dr. Harkonen in the civil action lawsuits and Criminal Action.

On January 13, 2009, we submitted to the American Arbitration Association (“AAA”) a Demand for Arbitration, InterMune, Inc. v. Arch Specialty Insurance Co., No. 74 194 01128 08 JEMO. Dr. Harkonen also is a party to the Arbitration. The Demand for Arbitration sought an award compelling Arch to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and the Criminal Action, and to advance other former officers’ legal fees and costs incurred in relation to the Department of Justice investigation.

The matter was heard by the arbitration panel and on May 29, 2009, the arbitration panel issued an Interim Arbitration Award granting our request for a partial award requiring Arch to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and Criminal Action. Arch subsequently advanced such fees and costs, including fees and costs previously paid by the Company. The question whether Arch ultimately will be required to cover the advanced fees and costs or, instead, may recoup those fees and costs as not covered by its policy, has not been determined. Unless and until the arbitration panel rules that such fees and costs are not covered, Arch remains obligated to advance such fees and costs. At this time, we believe no change to the status of the interim Arbitration Award or to the application of the D&O liability insurance in general has occurred due to the trial court judgment, and, therefore, we have not recorded any accrued liabilities associated with this matter.

In late 2009, Arch advised us that Arch had exhausted the $5.0 million limit of liability of the Arch D&O insurance policy, and that defense cost invoices submitted to Arch collectively exceed the Arch policy’s limit. The Company therefore advised the insurer that issued a $5.0 million D&O insurance policy providing coverage for the excess of the monetary limits of coverage provided by Arch, Old Republic Insurance Company (“Old Republic”), that the limits of the underlying coverage had been depleted, and we submitted invoices for legal services rendered on behalf of Dr. Harkonen and other individuals who were targets of the U.S. Department of Justice’s investigation to Old Republic for payment. Old Republic agreed to advance Dr. Harkonen’s legal fees and costs incurred in the civil action lawsuits and Criminal Action, but declined to reimburse us for payments made on behalf of other individuals who were targets of the U.S. Department of Justice’s investigation. In mid-2010, Old Republic advised us that Dr. Harkonen’s defense fees and costs had exhausted the $5 million limit of the Old Republic insurance policy as of the second quarter of 2010. There is no additional insurance coverage available to cover the cost of Dr. Harkonen’s continuing defense. Defense fees and costs incurred over and above this final $5 million of insurance coverage therefore are, in the absence of any available insurance, to be advanced by us pursuant to the terms of the Indemnity Agreement. We expect amounts to be paid by us to continue into the future until the Criminal Action is finally adjudicated, however we are unable to predict what our total liability could be with any degree of certainty.

Shionogi

In March 2012, following discussions between Shionogi & Co., Ltd (“Shionogi”) and us, Shionogi demanded that we agree that Shionogi is entitled to royalty payments on our net sales of pirfenidone (Esbriet^®) in Europe, based on Shionogi’s interpretation of our May 2004 agreement with Shionogi (as amended). On July 5, 2012, Shionogi filed a complaint against us in the United States District Court for the Northern District of California. Shionogi’s complaint alleges principally that we breached that agreement with Shionogi governing the exchange and use of certain documents and information relating to the parties’ respective clinical trials of pirfenidone. The complaint alleges that we breached the agreement by utilizing certain of Shionogi’s information in our Marketing Authorization Application and other submissions for pirfenidone with the EMA and then failing to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. In the alternative, the complaint alleges that, if we did not use Shionogi’s information in a way that would trigger a royalty obligation under the agreement, we had an obligation to do so as an exclusive licensee. Shionogi is seeking, among other things, unspecified monetary damages and a declaration that we are obligated to pay royalties to Shionogi on net sales of pirfenidone (Esbriet^®) in the European Union. While we strongly disagree that we owe any such royalties and intend to defend our position vigorously, an unfavorable outcome in the litigation with Shionogi could require that we pay royalties or make other payments to Shionogi.

X

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended

Jun. 30, 2012

Basis of Presentation

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year or any other future period and should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2011, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC).

Principles of consolidation

Principles of consolidation

The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Holdings Ltd. and InterMune UK & I Ltd., along with our other subsidiaries located in Canada, the United Kingdom, Germany, France, Switzerland, Spain, Italy, the Netherlands, Sweden and Austria. All inter-company balances and transactions have been eliminated.

Use of estimates

Use of estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates and assumptions.

We evaluate our estimates and assumptions on an ongoing basis, including those related to our allowances for doubtful accounts, product returns, chargebacks, cash discounts and rebates; excess/obsolete inventories; acquired product rights, the effects of inventory purchase commitments on inventory; certain accrued clinical and preclinical expenses and contingent liabilities and provision for income taxes. We base our estimates on historical experience and on various other specific assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Inventory valuation

Inventory valuation

Inventories are stated at the lower of cost or market. Cost is determined by the specific identification method. Inventories were $9.2 million and $6.2 million at June 30, 2012 and December 31, 2011, respectively, and consisted solely of Esbriet at June 30, 2012.

Because of the long lead times required to manufacture Esbriet, we enter into purchase obligations to satisfy our estimated inventory requirements. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current as well as committed purchases. We are also required to make judgments as to the expiration dates since the products are not usable beyond their expiration date. As part of our excess inventory assessment for Esbriet, we also consider the expiration dates of future manufactured quantities under these purchase obligations.

We incurred approximately $0.2 million for inventory writedowns during the quarter ended June 30, 2012. As of June 30, 2012, we had firm commitments to purchase approximately $0.6 million of Esbriet inventory.

Foreign Currency Exchange Risk

Foreign Currency Exchange Risk

In connection with our continuing expansion efforts, we now conduct business throughout Europe in several currencies, including the euro, Swiss franc and British pound, among others. Therefore, we are exposed to adverse movements in foreign currency exchange rates. To limit the exposure related to foreign currency changes, we enter into foreign currency contracts. The Company does not enter into such contracts for trading or speculative purposes.

We enter into foreign exchange forward contracts to reduce the short-term effects of foreign currency fluctuations on assets and liabilities such as foreign currency receivables and payables. These derivatives are not designated as hedging instruments. Gains and losses on the contracts are included in other income (expense) and substantially offset foreign exchange gains and losses from the remeasurement of intercompany balances or other current assets or liabilities denominated in currencies other than the functional currency of the reporting entity.

Our foreign exchange forward contracts expose us to credit risk to the extent that the counterparties may be unable to meet the terms of the agreement. We do, however, seek to mitigate such risks by limiting our counterparties to major financial institutions. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored. Management does not expect material losses as a result of defaults by counterparties.

Acquired Product Rights

Acquired Product Rights

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA or the European Commission (“EC”) for marketing are capitalized and amortized ratably over the estimated life of the products. At the time of acquisition, the product life is estimated based upon the term of the agreement, the remaining patent life of the product and our assessment of future sales and profitability of the product, which we currently estimate to be 20 years for Esbriet. We assess this estimate regularly during the amortization period and adjust the asset value and/or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA or EC for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development costs.

Revenue recognition and revenue reserves

Revenue recognition and revenue reserves

We recognize revenue from product sales generally upon delivery when title passes to a credit-worthy customer and record provisions for estimated returns, rebates, chargebacks and cash discounts against revenue. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.

Our European revenue from sales of Esbriet began in September 2011 and through June 30, 2012, has primarily been limited to revenue derived from sales in Germany. We only ship product upon receipt of valid orders from customers such as pharmacies and hospitals which are in turn a result of actual patient prescriptions. Pursuant to German Medicinal Products Law, a customer has no right to return the product; therefore we have not established a reserve for product returns, though we have established a reserve for the mandatory rebate as allowed under the applicable German health care regulations.

Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

In December 2010, we entered into a new agreement with Roche that focused on research to identify and develop next-generation protease inhibitors for the treatment of Hepatitis C virus. Under terms of the agreement, Roche funded all research costs related to the programs for the period from July 1, 2010 through June 30, 2011, the effective term of the research program. During 2011, we received $2.6 million from Roche as a reimbursement for research services performed which has been recorded as collaboration revenue. We will also be entitled to receive certain milestones and royalties in connection with the continued development and commercialization by Roche of any licensed compounds resulting from the research program.

Research and development expenses

Research and development expenses

Research and development (“R&D”) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations (“CRO”), licensing fees, acquired intellectual property with no alternative future use and facility and administrative expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase 1, Phase 2 and Phase 3 clinical trials. These costs are a significant component of our research and development expenses.

We accrue costs for clinical trial activities performed by contract research organizations and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities using available information; however, if we underestimate activity levels associated with various studies at a given point in time, we could be required to record significant additional R&D expenses in future periods when the actual activity level becomes known. We charge all such costs to R&D expenses. Non-refundable advance payments are capitalized and expensed as the related goods are delivered or services are performed.

Net loss per share

Net income (loss) per share

We compute basic net income (loss) per share by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period, as adjusted. We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net income per share by dividing the net income for the period by the weighted average number of common and potential common shares outstanding during the period. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method. For the computation of net loss per share we exclude dilutive securities, composed of potential common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, because of their anti-dilutive effect.

The shares excluded were as follows (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Options
 3,294 3,935 5,283 3,935

Shares issuable upon conversion of convertible notes
 9,384 4,502 9,384 4,502

The following table is a reconciliation of the denominator used in the calculation of basic and diluted net income (loss) per share attributable to our common stockholders (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Denominator:


Weighted-average shares of common stock outstanding
 65,468 59,889 65,357 58,660

Less: weighted-average shares subject to repurchase
 (525 ) (965 ) (499 ) (1,003 )



Weighted-average shares used in computing net income (loss) per share – basic
 64,943 58,924 64,858 57,657



Effect of dilutive securities (stock options, treasury stock method)
 250 — — —



Weighted-average shares used in computing net income (loss) per share – diluted
 65,193 58,924 64,858 57,657



Stock-Based Compensation

Stock-Based Compensation

The following table reflects stock-based compensation expense recognized for the three- and six-month periods ended June 30, 2012 and 2011 (in thousands):

 Three Months
Ended June 30, Six Months
Ended June 30,

 2012 2011 2012 2011

Cost of goods sold
 $ 54 $ — $ 107 $ —

Research and development
 1,135 1,008 2,440 3,100

Selling, general and administrative
 3,181 2,762 6,556 5,849









Total stock-based compensation expense
 $ 4,370 $ 3,770 $ 9,103 $ 8,949









Under the fair value recognition provisions of Accounting Standards Codification (ASC) Topic 718-10, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the vesting period for that portion of the award that is ultimately expected to vest. In order to estimate the value of share-based awards, we use the Black-Scholes model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility, the expected term of the award and the estimated forfeiture rate.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, Presentation of Comprehensive Income. This ASU gives an entity the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. We retrospectively adopted ASU No. 2011-05 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

In May 2011, the FASB issued ASU No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This ASU is the result of joint efforts by the FASB and International Accounting Standards Board to develop a single, converged fair value framework. While this ASU is largely consistent with existing fair value measurement principles in U.S. GAAP, it expands ASC No. 820, Fair Value Measurement existing disclosure requirements for fair value measurements and makes other amendments. Many of these amendments were made to eliminate unnecessary wording differences between U.S. GAAP and International Financial Reporting Standards, which could change how fair value measurement guidance in ASC 820 is applied. We prospectively adopted ASU No. 2011-04 on January 1, 2012. The adoption of this new guidance did not have an effect on our condensed consolidated balance sheets, statement of operations or cash flows.

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Summary of Amortized Cost and Estimated Fair Value of Available for Sale Securities (Detail) (USD $)
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In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended

Jun. 30, 2012

Jun. 30, 2011

Jun. 30, 2012

Jun. 30, 2011

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Other comprehensive income:

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FAIR VALUE
6 Months Ended

Jun. 30, 2012

FAIR VALUE

4. FAIR VALUE

In accordance with portions of ASC Topic No. 820, the following table represents the Company’s fair value hierarchy for its financial assets (cash, cash equivalents and investments, including accrued interest of approximately $0.5 million and $0.7 million, respectively) measured at fair value on a recurring basis as of June 30, 2012 and December 31, 2011 (in thousands):

June 30, 2012
 Level 1 Level 2 Level 3 Total

Money market funds
 $ 47,026 $ — $ — $ 47,026

Obligations of government-sponsored enterprises
 — 151,428 — 151,428

Corporate debt securities
 — 32,223 — 32,223

Commercial paper
 — 55,934 — 55,934









Total
 $ 47,026 $ 239,585 $ — $ 286,611









December 31, 2011
 Level 1 Level 2 Level 3 Total

Money market funds
 $ 82,693 $ — $ — $ 82,693

Obligations of government-sponsored enterprises
 — 140,887 — 140,887

Corporate debt securities
 — 31,815 — 31,815

Commercial paper
 — 36,985 — 36,985

Municipal bond
 — 4,510 — 4,510









Total
 $ 82,693 $ 214,197 $ — $ 296,890









The fair value of Level 1 assets have been determined using quoted prices in active markets for identical assets or liabilities.

To estimate the fair value of Level 2 debt securities as of June 30, 2012 and December 31, 2011, our primary pricing service relied on inputs from multiple industry-recognized pricing sources to determine the price for each investment. In addition, they performed reasonableness testing of their prices on a daily basis by comparing them to the prices reported by our custodians as well as prior day prices. If the price difference fell outside of tolerable levels, they investigated the cause and resolved the pricing issue. Based on a review of the results of this analysis, we utilized our primary pricing service for all Level 2 debt securities as none of these securities tested outside of the tolerable levels.

As of June 30, 2012 and December 31, 2011, our primary pricing service inputs for Level 2 cash equivalents (bonds), U.S. government sponsored enterprises, municipal obligations and corporate bonds consisted of market prices from a variety of industry standard data providers, security master files from large financial institutions and other third-party sources. These multiple market prices were used by our primary pricing service as inputs into a distribution-curve based algorithm to determine the daily market value.

As of June 30, 2012 and December 31, 2011, our primary pricing service inputs for Level 2 cash equivalents, commercial paper and corporate debt securities, consisted of dynamic and static security characteristics information obtained from several independent security characteristic sources. The dynamic inputs such as credit rating, factor and variable-rate, were updated daily. The static characteristics included inputs such as day count and first coupon upon initial security creation. These securities were typically priced via mathematical calculations reliant on these observable inputs.

The fair value of our long-term convertible debt is based on quoted prices for those instruments using readily available market information. As of June 30, 2012, the fair value of our $155.3 million 2.5% convertible senior notes due 2018 (“2018 Notes”) was $125.0 million and the fair value of our $85.0 million 5.0% convertible senior notes due 2015 (“2015 Notes”) was $92.0 million. As of December 31, 2011, the fair value of our 2018 Notes was $112.6 million and the fair value of our 2015 Notes was $84.1 million.

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Jun. 30, 2011

Jun. 30, 2012

Jun. 30, 2011

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Cost of goods sold

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Research and development

Share-based Compensation Arrangement by Share-based Payment Award

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Selling, General and Administrative Expenses

Share-based Compensation Arrangement by Share-based Payment Award

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Commitments and Contingencies - Additional Information (Detail) (USD $)
1 Months Ended 6 Months Ended

Apr. 30, 2011

Jun. 30, 2012

Mar. 18, 2008

LegalMatter

Dec. 31, 2009

Directors And Officers Insurance Policy

Loss Contingencies

Contingent milestone payments, aggregate amount $ 32,500,000

Future aggregate milestone payments 32,500,000

Contingent payments made 20,000,000

Reimbursement of future aggregate milestone payments 11,300,000

Post-trial penalties 20,000

Number of felony counts indicted on Dr. Harkonen 2

Carrying amount of insurance policy $ 5,000,000

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AVAILABLE-FOR-SALE INVESTMENTS (Tables)
6 Months Ended

Jun. 30, 2012

Summary Of Available-For-Sale Investments

The following is a summary of our available-for-sale investments as of June 30, 2012 and December 31, 2011 (in thousands):

 Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value

June 30, 2012


Obligations of government-sponsored enterprises
 $ 151,442 $ 18 $ (32 ) $ 151,428

Money market funds
 47,026 — — 47,026

Commercial paper
 55,931 3 — 55,934

Corporate debt securities
 32,168 58 (3 ) 32,223







Total
 $ 286,567 $ 79 $ (35 ) $ 286,611







 Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value

December 31, 2011


Obligations of government-sponsored enterprises
 $ 140,848 $ 48 $ (9 ) $ 140,887

Money market funds
 82,693 — — 82,693

Commercial paper
 36,983 2 — 36,985

Corporate debt securities
 31,788 35 (8 ) 31,815

Municipal bond
 4,510 — — 4,510







Total
 $ 296,822 $ 85 $ (17 ) $ 296,890







Summary Of Amortized Cost And Estimated Fair Value Of Available-For-Sale Securities

The following is a summary of the amortized cost and estimated fair value of available-for-sale securities at June 30, 2012 by contractual maturity (in thousands):

 June 30, 2012

 Amortized
Cost Fair Value

Mature in less than one year
 $ 241,665 $ 241,697

Mature in one to three years
 44,902 44,914

Mature in over three years
 — —





Total
 $ 286,567 $ 286,611





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Actimmune Divestiture - Additional Information (Detail) (USD $) In Millions, unless otherwise specified	1 Months Ended	6 Months Ended
	Jun. 30, 2012	Jun. 19, 2012
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations
Proceeds from divestiture of Actimmune	$ 55.0	$ 55.0
Conditional royalty payment period	2 years

Fair Value - Additional Information (Detail) (USD $) In Millions, unless otherwise specified			12 Months Ended		6 Months Ended
	Jun. 30, 2012	Dec. 31, 2011	Dec. 31, 2011 Two Point Five Percent Convertible Senior Notes Due To Two Thousand Eighteen	Jun. 30, 2012 Two Point Five Percent Convertible Senior Notes Due To Two Thousand Eighteen	Jun. 30, 2012 Five Point Zero Percent Convertible Senior Notes Due To Two Thousand Fifteen	Dec. 31, 2011 Five Point Zero Percent Convertible Senior Notes Due To Two Thousand Fifteen
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Cash equivalents and investments	$ 0.5	$ 0.7
Aggregate principal amount of convertible senior notes				155.3	85.0
Convertible senior notes, interest rate percentage				2.50%	5.00%
Fair value of convertible senior notes			$ 112.6	$ 125.0	$ 92.0	$ 84.1
Convertible senior notes, maturity date			Due 2018		Due 2015

Financial Assets Measured at Fair Value on Recurring Basis (Detail) (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	$ 286,611	$ 296,890
Money market funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	47,026	82,693
Obligations of government-sponsored enterprises
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	151,428	140,887
Corporate debt securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	32,223	31,815
Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	55,934	36,985
Municipal bond
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities		4,510
Fair Value, Inputs, Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	47,026	82,693
Fair Value, Inputs, Level 1 \| Money market funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	47,026	82,693
Fair Value, Inputs, Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	239,585	214,197
Fair Value, Inputs, Level 2 \| Obligations of government-sponsored enterprises
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	151,428	140,887
Fair Value, Inputs, Level 2 \| Corporate debt securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	32,223	31,815
Fair Value, Inputs, Level 2 \| Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities	55,934	36,985
Fair Value, Inputs, Level 2 \| Municipal bond
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Available-for-sale securities		$ 4,510

Revenue from Customers Representing Ten Percentage or More of Total Product Revenue (Detail) (Phoenix Pharmahandel Gmbh and Co)	6 Months Ended
	Jun. 30, 2012
Phoenix Pharmahandel Gmbh and Co
Revenue, Major Customer
Percentage of total product revenue	25.00%

CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Current assets:
Cash and cash equivalents	$ 135,339	$ 177,428
Available-for-sale securities	258,390	247,682
Accounts receivable, net of allowances of $20 and $56 at June 30, 2012 and December 31, 2011, respectively	4,702	3,764
Inventories	9,152	6,220
Prepaid expenses and other current assets	6,064	8,044
Total current assets	413,647	443,138
Property and equipment, net	4,118	2,341
Acquired product rights	18,750	19,250
Other assets (includes restricted cash of $1,674 at June 30, 2012 and $1,427 at December 31, 2011)	7,588	7,894
Total assets	444,103	472,623
Current liabilities:
Accounts payable	12,282	10,068
Accrued compensation	7,577	9,044
Other accrued liabilities	21,217	14,979
Total current liabilities	41,076	34,091
Convertible notes	240,250	240,250
Other long term liabilities	185	114
Commitments and contingencies
Stockholders' equity:
Common stock	66	65
Additional paid-in capital	1,155,311	1,144,947
Accumulated other comprehensive income	1,221	1,025
Accumulated deficit	(994,006)	(947,869)
Total stockholders' equity	162,592	198,168
Total liabilities and stockholders' equity	$ 444,103	$ 472,623

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) In Thousands, unless otherwise specified	6 Months Ended
	Jun. 30, 2012	Jun. 30, 2011
Cash flows used in operating activities:
Net loss	$ (46,137)	$ (71,997)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on sale of discontinued operations	(51,335)
Amortization and depreciation	1,401	1,727
Stock-based compensation expense	9,103	8,949
Net realized gains on sales of available for sale securities		(15)
Other	290	(260)
Changes in operating assets and liabilities:
Accounts receivable, net	(938)	42
Inventories	(4,661)	(3,790)
Other assets	1,878	(1,878)
Accounts payable and accrued compensation	747	3,541
Other accrued liabilities	4,302	1,344
Net cash used in operating activities	(85,350)	(62,337)
Cash flows from investing activities:
Proceeds from the divestiture of Actimmune	55,000
Acquisition of product rights		(20,000)
Purchases of property and equipment	(2,270)	(321)
Purchases of available-for-sale securities	(240,345)	(143,246)
Sales of available-for-sale securities	84,533	37,937
Maturities of available-for-sale securities	145,081	106,684
Net cash provided by (used in) investing activities	41,999	(18,946)
Cash flows from financing activities:
Proceeds from issuance of common stock under employee stock benefit plans	1,262	33,194
Net cash provided by financing activities	1,262	33,194
Net decrease in cash and cash equivalents	(42,089)	(48,089)
Cash and cash equivalents at beginning of period	177,428	110,584
Cash and cash equivalents at end of period	135,339	62,495
Non-cash financing activities:
Issuance of common stock in exchange for convertible debt		$ 44,963

Derivative Instruments - Additional Information (Detail) In Millions, unless otherwise specified	6 Months Ended
	Jun. 30, 2012 USD ($)	Jun. 30, 2012 EUR (€)
Derivative
Derivative financial instruments not designated as hedges, net loss	$ 0.2
Notional value of outstanding currency hedges		13.0
Fair value of outstanding derivatives		€ 0

Acquired Product Rights - Additional Information (Detail) (USD $) In Millions, unless otherwise specified	1 Months Ended		6 Months Ended	12 Months Ended	6 Months Ended	11 Months Ended	12 Months Ended
	Mar. 31, 2011	Mar. 31, 2009	Jun. 30, 2012	Dec. 31, 2011	Jun. 30, 2012 Marnacinc And Kdl	Nov. 30, 2007 Marnacinc And Kdl	Dec. 31, 2002 Marnacinc And Kdl
Acquired Finite-Lived Intangible Assets
Payment to acquire product rights and licenses						$ 13.7	$ 18.8
Future royalty payments percentage for license acquisition							9.00%
Milestone payments for license acquisition	20.0	13.5
Estimated useful life (in years)				20 years
Amortization expense			0.5
Future amortization expense, 2012			1.0
Future amortization expense, 2013			1.0
Future amortization expense, 2014			1.0
Future amortization expense, 2015			1.0
Future amortization expense, 2016			1.0
Contingent payment based on product approval in United States					$ 20.0

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Accounts receivable, allowances	$ 20	$ 56
Other assets, restricted cash	$ 1,674	$ 1,427

Document and Entity Information	6 Months Ended
Document and Entity Information	Jun. 30, 2012	Jul. 31, 2012
Document Information
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2012
Document Fiscal Year Focus	2012
Document Fiscal Period Focus	Q2
Trading Symbol	ITMN
Entity Registrant Name	INTERMUNE INC
Entity Central Index Key	0001087432
Current Fiscal Year End Date	--12-31
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		65,739,097

Organization - Additional Information (Detail) (USD $) In Thousands, unless otherwise specified	1 Months Ended	6 Months Ended
	Jun. 30, 2012	Jun. 19, 2012
Organization and Nature of Operations [Line Items]
Cash proceeds received from sale	$ 55,000	$ 55,000
European Union \| Marketing Authorization
Organization and Nature of Operations [Line Items]
Number of member countries of the European Union ("EU") in which marketing authorization is granted	27

Summary of Amortized Cost and Estimated Fair Value of Available for Sale Securities (Detail) (USD $) In Thousands, unless otherwise specified	Jun. 30, 2012	Dec. 31, 2011
Schedule of Available-for-sale Securities
Available-for-sale securities, Mature in less than one year, Amortized Cost	$ 241,665
Available-for-sale securities, Mature in one to three years, Amortized Cost	44,902
Available-for-sale securities, Mature in over three years, Amortized Cost
Available-for-sale securities, Amortized Cost, Total	286,567
Available-for-sale securities, Mature in less than one year, Fair Value	241,697
Available-for-sale securities, Mature in one to three years, Fair Value	44,914
Available-for-sale securities, Mature in over three years, Fair Value
Available-for-sale securities, Fair Value, Total	$ 286,611	$ 296,890

Commitments and Contingencies - Additional Information (Detail) (USD $)	1 Months Ended	6 Months Ended
	Apr. 30, 2011	Jun. 30, 2012	Mar. 18, 2008 LegalMatter	Dec. 31, 2009 Directors And Officers Insurance Policy
Loss Contingencies
Contingent milestone payments, aggregate amount		$ 32,500,000
Future aggregate milestone payments		32,500,000
Contingent payments made		20,000,000
Reimbursement of future aggregate milestone payments		11,300,000
Post-trial penalties	20,000
Number of felony counts indicted on Dr. Harkonen			2
Carrying amount of insurance policy				$ 5,000,000