10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the Quarterly Period Ended: March 31, 2018

☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number: 001-36329

Recro Pharma, Inc.

(Exact name of registrant as specified in its charter)

Pennsylvania	26-1523233
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
490 Lapp Road, Malvern, Pennsylvania	19355
(Address of principal executive offices)	(Zip Code)

(484) 395-2470

(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  ☒    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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

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

Large accelerated filer	☐	Accelerated filer	☒
Non-accelerated filer	☐  (Do not check if a smaller reporting company)	Smaller reporting company	☐
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section13(a) 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  ☒

As of May 7, 2018, there were 20,507,616 shares of common stock, par value $0.01 per share, outstanding.

TABLE OF CONTENTS

Index

			Page
PART I. FINANCIAL INFORMATION			3
	Item 1.	Consolidated Financial Statements (Unaudited)	3
	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	26
	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36
	Item 4.	Controls and Procedures	36
PART II. OTHER INFORMATION			37
	Item 1.	Legal Proceedings	37
	Item 1A.	Risk Factors	37
	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	37
	Item 3.	Defaults Upon Senior Securities	37
	Item 4.	Mine Safety Disclosures	37
	Item 5.	Other Information	37
	Item 6.	Exhibits	38
SIGNATURES			40

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

RECRO PHARMA, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(Unaudited)

(amounts in thousands, except share and per share data)	March 31, 2018			December 31, 2017
Assets
Current assets:
Cash and cash equivalents	$	46,284		$	60,984
Short-term investments		4,989			3,498
Accounts receivable		9,833			9,686
Contract asset		5,508			—
Inventory		10,028			9,839
Prepaid expenses and other current assets		2,686			3,276
Total current assets		79,328			87,283
Property, plant and equipment, net		38,486			39,074
Deferred income taxes		19,989			18,573
Intangible assets, net		34,204			34,850
Goodwill		6,446			6,446
Total assets	$	178,453		$	186,226
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable	$	4,336		$	7,954
Accrued expenses and other current liabilities		6,361			9,897
Current portion of contingent consideration		33,957			32,053
Total current liabilities		44,654			49,904
Long-term debt, net		53,957			53,598
Warrants and other long-term liabilities		4,290			3,516
Long-term portion of contingent consideration		50,976			50,360
Total liabilities		153,877			157,378
Commitments and contingencies (Note 13)
Shareholders’ equity:
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and    outstanding		—			—
Common stock, $0.01 par value. Authorized, 50,000,000 shares; issued and    outstanding, 19,550,414 shares at March 31, 2018 and 19,127,435 shares at    December 31, 2017		195			191
Additional paid-in capital		145,367			140,006
Accumulated deficit		(120,985	)		(111,348	)
Accumulated other comprehensive loss		(1	)		(1	)
Total shareholders’ equity		24,576			28,848
Total liabilities and shareholders’ equity	$	178,453		$	186,226

See accompanying notes to consolidated financial statements.

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RECRO PHARMA, INC. AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

	For the Three Months Ended March 31,
(amounts in thousands, except share and per share data)	2018			2017
Revenue	$	19,542		$	18,742
Operating expenses:
Cost of sales (excluding amortization of intangible assets)		10,490			10,498
Research and development		8,442			7,763
General and administrative		9,518			4,032
Amortization of intangible assets		646			646
Change in warrant valuation		773			291
Change in contingent consideration valuation		2,520			2,814
Total operating expenses		32,389			26,044
Operating loss		(12,847	)		(7,302	)
Other income (expense):
Interest income		142			105
Interest expense		(2,103	)		(1,183	)
Net loss before income taxes		(14,808	)		(8,380	)
Income tax benefit		2,353			293
Net loss	$	(12,455	)	$	(8,087	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.65	)	$	(0.42	)
Weighted average common shares outstanding, basic and diluted		19,219,257			19,049,416
Net Loss	$	(12,455	)	$	(8,087	)
Other comprehensive loss:
Unrealized loss on available-for-sale securities		—			(57	)
Comprehensive loss	$	(12,455	)	$	(8,144	)

See accompanying notes to consolidated financial statements.

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RECRO PHARMA, INC. AND SUBSIDIARIES

Consolidated Statements of Shareholders’ Equity

For the Three Months Ended March 31, 2018

(Unaudited)

	Common Stock				Additional						Accumulated other
(amounts in thousands, except share data)	Shares		Amount		paid-in capital			Accumulated Deficit			comprehensive loss			Total
Balance, December 31, 2017		19,127,435	$	191	$	140,006		$	(111,348	)	$	(1	)	$	28,848
Stock-based compensation expense		—		—		1,584			—			—			1,584
Stock option exercise		14,575		—		65			—			—			65
Issuance of restricted stock units, net of    shares withheld for income taxes		25,364		—		(86	)		—			—			(86	)
Sale of common stock under equity    facility, net of transaction costs		383,040		4		3,798			—			—			3,802
Other comprehensive loss		—		—		—			—			—			—
Net loss		—		—					(12,455	)		—			(12,455	)
Cumulative effect of adoption of new accounting standards, net of tax		—		—		—			2,818			—			2,818
Balance, March 31, 2018		19,550,414	$	195	$	145,367		$	(120,985	)	$	(1	)	$	24,576

See accompanying notes to consolidated financial statements.

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RECRO PHARMA, INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(Unaudited)

	For the Three Months Ended March 31,
(amounts in thousands)	2018			2017
Cash flows from operating activities:
Net loss	$	(12,455	)	$	(8,087	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		1,584			892
Non-cash interest expense		319			158
Depreciation expense		1,216			1,196
Amortization		646			646
Change in warrant valuation		773			291
Change in contingent consideration valuation		2,520			2,814
Deferred income taxes		(2,353	)		(1,235	)
Inventory		(189	)		936
Contract Asset		(1,753	)		—
Prepaid expenses and other current assets		912			(518	)
Accounts receivable		(147	)		(1,867	)
Accounts payable, accrued expenses and other liabilities		(5,870	)		(2,363	)
Net cash used in operating activities		(14,797	)		(7,137	)
Cash flows from investing activities:
Purchase of property and equipment		(1,654	)		(1,744	)
Purchase of short-term investments		(4,981	)		(36,117	)
Proceeds from maturity of investments		3,500			—
Net cash used in investing activities		(3,135	)		(37,861	)
Cash flows from financing activities:
Payment of deferred financing costs		(261	)		—
Proceeds from sale of common stock, net of transaction costs		3,514			—
Payments of withholdings on shares withheld for income taxes		(86	)		—
Proceeds from option exercise		65			—
Net cash provided by financing activities		3,232			—
Net decrease in cash and cash equivalents		(14,700	)		(44,998	)
Cash and cash equivalents, beginning of period		60,984			64,483
Cash and cash equivalents, end of period	$	46,284		$	19,485
Supplemental disclosure of cash flow information:
Cash paid for interest	$	2,546		$	1,026
Purchase of property, plant and equipment included in accrued expenses and accounts payable	$	249		$	237
Retirement of fully depreciated property, plant and equipment	$	30		$	—
Common stock issued in connection with equity facility	$	357		$	—

See accompanying notes to consolidated financial statements.

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RECRO PHARMA, INC. AND SUBSIDIARIES

Notes to the Consolidated Financial Statements

(amounts in thousands, except share and per share data)

(Unaudited)

(1) Background

Recro Pharma, Inc., or the Company, was incorporated in Pennsylvania on November 15, 2007. The Company is a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating contract development and manufacturing, or CDMO division. Each of these divisions are deemed to be reportable segments (see Note 3(m) and Note 17). The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings, and the CDMO division leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. On April 10, 2015, the Company acquired from Alkermes plc, or Alkermes, worldwide rights to intravenous and intramuscular, or injectable, meloxicam, a proprietary long-acting preferential COX-2 inhibitor being developed for the management of moderate to severe pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, Georgia. The acquisition is referred to herein as the Gainesville Transaction. In July 2017, the Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or the FDA, for its lead investigational product candidate intravenous, or IV, meloxicam 30 mg for the management of moderate to severe pain. The FDA has accepted the NDA for review and has set a Prescription Drug User Fee Act, or PDUFA, date of May 26, 2018.

(2) Development-Stage Risks and Liquidity

The Company has incurred losses from operations since inception and has an accumulated deficit of $120,985 as of March 31, 2018. Though its CDMO segment has been profitable, the Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its products currently in development. Additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates, including the payment of the Gainesville Transaction contingent payments, which may become due upon achievement of certain development and commercialization milestones for meloxicam (see Note 4). Insufficient funds may cause the Company to delay, reduce the scope of or eliminate one or more of its development, commercialization or expansion activities. The Company may raise such funds through debt refinancing, bank or other loans, through strategic research and development, licensing (including out-licensing) and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and failure to raise capital when needed could materially adversely impact the Company’s growth plans and its financial condition or results of operations. Additional equity financing, if available, may be dilutive to the holders of its common stock and may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate its business. The Company’s future operations are highly dependent on a combination of factors, including (i) the continued profitability of the CDMO segment; (ii) the timely and successful completion of additional financing and/or alternative sources of capital, debt, partnering or out-licensing transactions; (iii) the success of its research and development, including the results and timing of its clinical trials; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market acceptance of the Company’s proposed future products. Management believes that the Company’s existing cash, cash equivalents and short-term investments as of March 31, 2018 and other expected financing sources will be sufficient to fund its operations over the next twelve months.

(3) Summary of Significant Accounting Principles

(a) Basis of Presentation and Principles of Consolidation

The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2018.

The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

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(b) Use of Estimates

The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP 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 revenues and expenses during the reporting period. Actual results could differ from such estimates.

(c) Cash and Cash Equivalents

Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of the changes in interest rates.

(d) Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture and office equipment; six to ten or more years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred.

(e) Business Combinations

In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805, “Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date.

(f) Goodwill and Intangible Assets

Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a two-step method for determining impairment.

The first step compares a reporting unit’s fair value to its carrying amount to identify potential goodwill impairment. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the second step of the impairment test must be completed to measure the amount of the reporting unit’s goodwill impairment loss, if any. Step two requires an assignment of the reporting unit’s fair value to the reporting unit’s assets and liabilities to determine the implied fair value of the reporting unit’s goodwill. The implied fair value of the reporting unit’s goodwill is then compared with the carrying amount of the reporting unit’s goodwill to determine the goodwill impairment loss to be recognized, if any.

Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an IPR&D asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is amortized on a straight-line basis over a useful life of six years.

Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations and Comprehensive Loss. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.

The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a

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triggering event occurs between annual assessments, which would then require an assessment in the period which a triggering event occurred. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30^th, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. In performing the evaluation, the Company assessed qualitative factors such as overall financial performance of its reporting units, anticipated changes in industry and market conditions, including recent tax reform, and competitive environments. As a result of the latest impairment tests, November 30, 2017, the Company determined that there was no impairment to goodwill or indefinite-lived intangible assets. Additionally, there were no indicators of impairment as of March 31, 2018.

(g) Revenue Recognition

The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components.  The Company’s revenue policies listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “Revenue from Contracts with Customers,” or ASU 2014-09,which the company adopted effective January 1, 2018.  See footnote 18 for additional information regarding the Company’s adoption of ASU 2014-09 and its impact on the Company’s financial statements.

Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments.

In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the commercial partner.  For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of the manufactured product.  In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s commercial partners.

Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received.

(h) Concentration of Credit Risk

Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity.

The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition.

The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four largest customers having generated 99% of its revenues for three months ended March 31, 2018. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the U.S.

9

(i) Research and Development

Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expenses relating to these costs.

Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use.

(j) Stock-Based Awards

The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award.

Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards.

The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option.

Non-employee stock-based awards are revalued until an award vests and the Company recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, which is known as the accelerated attribution method. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are revised.

(k) Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year.

(l) Net Loss Per Common Share

Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period.  For all periods presented, the outstanding common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive.  

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For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.  There are no dilutive common stock equivalents for the three months ended March 31, 2018.

The following table sets forth the computation of basic and diluted loss per share:

	Three Months Ended March 31,
	2018			2017
Basic and Diluted Loss Per Share
Net loss	$	(12,455	)	$	(8,087	)
Weighted average common shares outstanding, basic and diluted		19,219,257			19,049,416
Net loss per share of common stock, basic and diluted	$	(0.65	)	$	(0.42	)

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive:

	March 31,
	2018		2017
Options and restricted stock units outstanding		4,973,043		3,337,461
Warrants		1,133,592		784,928

Amounts in the table above reflect the common stock equivalents of the noted instruments.

(m) Segment Information

The Company determined its reportable segments based on its strategic business units, the commonalities among the products and services within each segment and the manner in which the Company reviews and evaluates operating performance. The Company has identified its CDMO and Acute Care divisions as reportable segments. Segment disclosures are included in Note 17. Segment operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of general and administrative expenses, research and development expenses, and the change in valuation of contingent consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and expense, and income tax benefit. Segment assets are those assets and liabilities that are recorded and reported by segment operations. Segment operating capital employed represents segment assets less segment liabilities.

(n) Recent Accounting Pronouncements

In May 2017, the FASB issued ASU No. 2017-09, “Stock Compensation - Scope of Modification Accounting” or ASU 2017-09.  ASU 2017-09 provides guidance on which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new standard is effective for fiscal years beginning after December 15, 2017. The Company adopted the guidance effective January 1, 2018. There was no impact upon adoption.

In January 2017, the FASB issued ASU No. 2017-04 “Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment,” or ASU 2017-04. ASU 2017-04 allows companies to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The amendments of the ASU are effective for annual or interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” or ASU 2016-02. ASU 2016-02 establishes a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The new guidance is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed.

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In January 2018, the Company adopted the standard using the modified retrospective method. See Footnote 18 for additional information on the impact of the transition on the Company’s financial statements.

(4) Acquisition of Gainesville Facility and Meloxicam

On April 10, 2015, the Company completed the Gainesville Transaction. The consideration paid in connection with the Gainesville Transaction consisted of $50,000 cash at closing, a $4,000 working capital adjustment and a seven-year warrant to purchase 350,000 shares of the Company’s common stock at an exercise price of $19.46 per share. In addition, the Company may be required to pay up to an additional $125,000 in milestone payments including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and a percentage of future product net sales related to injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and royalties were allocated to the fair value of the assets acquired and liabilities assumed. The contingent consideration obligation is remeasured each reporting date with changes in fair value recognized as a period charge within the statement of operations (see Note 6 for further information regarding fair value).

The contingent consideration consists of three separate components. The first component will be payable upon regulatory approval. The second component consists of three potential payments, based on the achievement of specified annual revenue targets, the last of which represents over 60% of these milestone payments and currently does not have a fair value assigned to its achievement. The third component consists of a royalty payment between 10% and 12% (subject to a 30% reduction when no longer covered by patent) for a defined term on future meloxicam net sales.

The fair value of the first contingent consideration component recognized on the acquisition date was estimated by applying a risk-adjusted discount rate to the probability-adjusted contingent payments and the expected approval dates. The fair value of the second contingent consideration component recognized on the acquisition date was estimated using the Monte Carlo simulation method and applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections based upon the expected revenue target attainment dates. The fair value of the third contingent consideration component recognized on the acquisition date was estimated by applying a risk-adjusted discount rate to the potential payments resulting from revenue projections and the defined royalty percentage.

These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs. The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair value through the results of operations.

(5) NMB Related License Agreement

In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBs, and a proprietary reversal agent from Cornell University, or Cornell. The NMBs and reversal agent are referred to herein as the NMB Related Compounds. The NMB Related Compounds include one novel intermediate-acting NMB that has initiated Phase I clinical trials and two other agents, a novel short-acting NMB, and a rapid-acting reversal agent specific to these NMBs.

The transaction was accounted for as an asset acquisition, with the total cost of the acquisition of $766 allocated to acquired IPR&D. The Company recorded an upfront payment obligation of $350, as well as operational liabilities and acquisition-related costs of $416, primarily consisting of reimbursement to Cornell for specified past patent, legal and pre-clinical costs, of which $247 is reported as a component of Accrued expenses and other current liabilities and Other non-current liabilities on the Consolidated Balance Sheet as of March 31, 2018.

In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the NMB Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each NMB, of $5,000 for U.S. regulatory approval and commercialization milestones and $3,000 for European regulatory approval and commercialization milestones. The Company is also obligated to pay Cornell royalties on net sales of the NMB Related Compounds at a rate ranging from low to mid-single digits, depending on the applicable NMB Related Compounds and whether there is a valid patent claim in the applicable country, subject to an annual minimum royalty amount. Further, the Company will reimburse Cornell ongoing patent costs related to prosecution and maintenance of the patents related to the Cornell patents for the NMB Related Compounds.

The Company accounted for the transaction as an asset acquisition based on an evaluation of the accounting guidance (ASC Topic 805) and considered the early clinical stage of the novel and unproven NMB Related Compounds. The Company concluded that the acquired IPR&D of Cornell did not constitute a business as defined under ASC 805 due to the incomplete nature of the inputs and the absence of processes from a market participant perspective. Substantial additional research and development will be required to develop any NMB Related Compounds into a commercially viable drug candidate, including completion of pre-clinical testing and clinical trials, and, if such clinical trials are successful, application for regulatory approvals and manufacturing repeatability and scale-up. There is risk that a marketable compound may not be well tolerated and may never be approved.

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Acquired IPR&D in the asset acquisition was accounted for in accordance with FASB ASC Topic 730, “Research and Development.” At the date of acquisition, the Company determined that the development of the projects underway at Cornell had not yet reached technological feasibility and that the research in process had no alternative future uses.  Accordingly, the acquired IPR&D was charged to expense in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. The acquired IPR&D charge is expected to be deductible over a 15-year period for income tax purposes.

(6) Fair Value of Financial Instruments

The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments, warrants and the contingent consideration. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows:

• Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

• Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and

• Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

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The Company has classified assets and liabilities measured at fair value on a recurring basis as follows:

	Fair value measurements at reporting date using
	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)
At December 31, 2017:
Assets:
Cash equivalents
Money market mutual funds	$	38,959	$	—	$	—
Total cash equivalents	$	38,959	$	—	$	—
Short-term investments
U.S. Treasury obligations	$	3,498	$	—	$	—
Total financial assets	$	42,457	$	—	$	—
Liabilities:
Warrants		—		—	$	3,406
Contingent consideration		—		—		82,413
	$	—	$	—	$	85,819
At March 31, 2018:
Assets:
Cash equivalents
Money market mutual funds (See Note 7)	$	4,162	$	—	$	—
U.S. Treasury obligations (See Note 7)	$	9,989
Commercial Paper (See Note 7)			$	17,972
Total cash equivalents	$	14,151	$	17,972	$	—
Short-term investments
U.S. Treasury obligations (See Note 7)	$	1,998	$	—	$	—
Commercial Paper (See Note 7)			$	2,991	$	—
Total financial assets	$	16,149	$	20,963	$	—
Liabilities:
Warrants (See Note 14(d))		—		—	$	4,179
Contingent consideration (See Note 4)		—		—		84,933
	$	—	$	—	$	89,112

The Company developed its own assumptions to determine the value of the warrants that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility, the contractual term of the warrants, risk free interest rates and dividend yield. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement.  

The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:

	Warrants		Contingent Consideration
Balance at December 31, 2017	$	3,406	$	82,413
Additions		—		—
Remeasurement		773		2,520
Total at March 31, 2018	$	4,179	$	84,933
Current portion as of March 31, 2018		—		33,957
Long-term portion as of March 31, 2018		4,179		50,976

The current portion of the contingent consideration represents the estimated probability adjusted fair value that is expected to become payable within one year as of March 31, 2018 (see Note 4 for additional information).

The Company follows the disclosure provisions of FASB ASC Topic 825, “Financial Instruments” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of March 31, 2018, the financial assets and liabilities

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recorded on the Consolidated Balance Sheets that are not measured at fair value on a recurring basis include accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of these instruments. The fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of long-term debt approximated fair value at March 31, 2018 due to the comparison of the terms of the debt, including borrowing rates available to the Company through its recent completed debt refinancing process, availability of additional term loan tranches, and maturity.

(7) Short-term Investments

Short-term investments as of March 31, 2018 consist of government money market funds, U.S. Treasury obligations and commercial paper. A portion of short term investments is included in Cash and cash equivalents due to its original maturity of three months or less when acquired. In accordance with FASB ASC Topic 320, “Investments – Debt and Equity Securities,” the Company has classified its entire investment portfolio as available-for-sale securities with secondary or resale markets, and, as such, its portfolio is reported at fair value with unrealized gains and losses included in Comprehensive Income in stockholders’ equity and realized gains and losses included in other income/expense. The following is a summary of available-for-sale securities as of March 31, 2018.

	March 31, 2018
	Amortized		Gross Unrealized					Estimated
Description	Cost		Gain		Loss			Fair Value
Money market mutual funds	$	4,162	$	—	$	—		$	4,162
U.S. Treasury obligations		11,987		—		—			11,987
Commercial Paper		20,963		1		(1	)		20,963
Total investments	$	37,112	$	1	$	(1	)	$	37,112

As of March 31, 2018, the Company’s investments had maturities ranging from one to four months. As of December 31, 2017, all of the Company’s investments in U.S. Treasury obligations had original maturities of less than two months. The fair value of the Company’s U.S. Treasury obligations is determined by taking into consideration valuations obtained from third-party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, and other observable inputs. To derive the fair value of its commercial paper, the Company uses benchmark inputs and industry standard analytical models.

Certain investment securities as of March 31, 2018 had fair values less than their amortized costs and, therefore, contained unrealized losses. The Company has evaluated these investments and has determined that the decline in value was not related to any Company or industry specific event. As of March 31, 2018, there were two investments with unrealized losses. The gross unrealized losses related to these investments were due to changes in interest rates. Given that the Company has no intent to sell any of these investments until a recovery of its fair value, which may be at maturity, and there are no current requirements to sell any of these investments, the Company did not consider these investments to be other-than-temporarily impaired as of March 31, 2018. The Company anticipates full recovery of amortized costs with respect to these investments at maturity or sooner in the event of a more favorable market interest rate environment. The duration of time the investments had been in a continuous unrealized loss position as of March 31, 2018 was less than six months.

(8) Inventory

Inventory is stated at the lower of cost and net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Cost is determined using the first-in, first-out method. The Company expenses costs related to inventory until such time as it receives approval from the FDA to market a product, at which time the Company commences capitalization of costs relating to that product.

Inventory was as follows as of March 31, 2018 and December 31, 2017:

	March 31, 2018			December 31, 2017
Raw materials	$	2,645		$	2,130
Work in process		4,672			3,931
Finished goods		3,551			4,488
		10,868			10,549
Provision for inventory obsolescence		(840	)		(710	)
	$	10,028		$	9,839

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Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Inventory is ordered to meet specific customer orders and largely reflects demand. Factors influencing inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns.

(9) Property, Plant and Equipment

Property, plant and equipment consists of the following:

	March 31, 2018		December 31, 2017
Land	$	3,263	$	3,263
Building and improvements		15,771		15,751
Furniture, office and computer equipment		4,633		4,406
Manufacturing equipment		24,603		24,153
Construction in progress		5,227		5,326
		53,497		52,899
Less: accumulated depreciation and amortization		15,011		13,825
Property, plant and equipment, net	$	38,486	$	39,074

Depreciation expense for the three months ended March 31, 2018 and 2017 was $1,216 and $1,196, respectively.

(10) Intangible Assets

The following represents the balance of the intangible assets at March 31, 2018:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,696	$	7,804
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,696	$	34,204

The following represents the balance of intangible assets at December 31, 2017:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,050	$	8,450
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,050	$	34,850

Amortization expense for each of the three months ended March 31, 2018 and 2017 was $646.

As of March 31, 2018, future amortization expense is as follows:

	Amortization
2018		1,937
2019		2,583
2020		2,583
2021		701
Total	$	7,804

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(11) Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

	March 31,		December 31,
	2018		2017
Clinical trial and related costs	$	367	$	383
Professional and consulting fees		926		1,010
Payroll and related costs		3,247		6,387
Property plant and equipment		6		216
Deferred revenue		818		546
Interest payable		—		802
Other		997		553
	$	6,361	$	9,897

(12) Long-Term Debt

On November 17, 2017, the Company entered into a $10,000 Credit Agreement, or the Credit Agreement, with Athyrium Opportunities III Acquisition LP, or Athyrium. The Credit Agreement provides for an initial term loan in the original principal amount of $60,000 funded at closing. Pursuant to the terms of the Credit Agreement, there are two additional tranches of term loans, each in an aggregate original principal amount of $20,000. The second tranche term loan may be drawn upon on or before December 31, 2018 provided that the Company receives regulatory approval of the Company’s IV meloxicam product candidate and will have at least $20,000 in unrestricted cash after payment of the milestone payment due to Alkermes. The third tranche term loan may be drawn upon at any time on or prior to March 31, 2020 provided that the second term loan has been drawn upon and net sales of IV Meloxicam achieve $20,000 for the most recent trailing twelve-month period. The maturity date of the Credit Agreement is November 17, 2022, the five-year anniversary of the closing.

The Term Loans will bear interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum, with quarterly, interest-only payments until the maturity date. The unpaid principal amount of the Term Loans is due and payable on the maturity date. In addition, in accordance with the Credit Agreement the Company will have to pay a 1% exit fee of $600, which will be accreted to the carrying amount of the debt using the effective interest method over the term of the loan. In addition, if there is an early repayment, there is a sliding scale of prepayment penalties.

The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis. As of March 31, 2018, the Company was in compliance with the covenants.

As of March 31, 2018, the remaining payments due under the Credit Agreement include a principal payment of $60,000 and an exit fee of $600 due at the maturity date.

In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP, or Athyrium II, to purchase an aggregate of 348,664 shares of the Company’s common stock with an exercise price of $8.6043 per share. See Note 14(d) for additional information. The warrants are exercisable through November 17, 2024. The initial fair value of the warrant of $2,143 was recorded as a debt issuance cost.  

In addition, the Company recorded debt issuance costs for the Credit Agreement of $4,439, which, along with the fair value of warrants, are being amortized using the effective interest method over the term of the Credit Agreement. Debt issuance cost amortization is included in interest expense within the Consolidated Statements of Operations and Comprehensive Loss. As of March 31, 2018, the effective interest rate was 15.04%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt issuance cost.

The components of the carrying value of the debt as of March 31, 2018, are detailed below:

Principal balance outstanding	$	60,000
Unamortized deferred issuance costs		(6,088	)
Exit fee accretion		45
Total	$	53,957

The Company used proceeds from the $60,000 initial term loan to (i) repay in full all outstanding indebtedness under its previous credit facility governed by the Credit Agreement, dated April 10, 2015, between the Company’s subsidiary, Recro Gainesville LLC

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and OrbiMed Royalty Opportunities II, LP, or the OrbiMed Credit Agreement of $31,767, which included the remaining debt principal balance of $27,347 and early termination charges of $4,420 and (ii) pay transaction fees associated with the Athyrium Credit Agreement of $4,178.

Associated with the refinancing of the OrbiMed Credit Agreement and in accordance with ASC 405-20 “Extinguishments of Liabilities”, the Company booked one-time loss on extinguishment of $6,772 as of December 31, 2017, which was reflected in the interest expense line within the Consolidated Statement of Operations and Comprehensive Loss.

The Company recorded debt issuance cost amortization for both credit agreements of $329 and $158 for the three months ended March 31, 2018 and 2017, respectively.

(13) Commitments and Contingencies

(a) Licenses

The Company is party to an exclusive license with Orion for the development and commercialization of Dexmedetomidine, or Dex, for use in the treatment of pain in humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational) delivery, but specifically excluding delivery vehicles for administration by injection or infusion, worldwide, except for Europe, Turkey and the CIS (currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan), referred to herein as the Territory. The Company is required to pay Orion lump sum payments of up to €20,500 ($25,257 as of March 31, 2018) on the achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 20% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved.

The Company is also party to an exclusive license agreement with Orion for the development and commercialization of Fadolmidine, or Fado, for use as a human therapeutic, in any dosage form in the Territory. The Company is required to pay Orion lump sum payments of up to €12,200 ($15,031 as of March 31, 2018) on achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 15% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved.

The Company is party to a license agreement with Cornell University for the exclusive license of the NMB Related Compounds. Under the terms of the agreement, the Company will pay Cornell an initial upfront fee and Cornell is also entitled to receive additional milestone payments, annual license maintenance fees as well as royalties. See Note 5 for further information regarding these payment obligations.

(b) Contingent Consideration for the Gainesville Transaction

Pursuant to the purchase and sale agreement governing the Gainesville Transaction, the Company agreed to pay to Alkermes up to an additional $125,000 in milestone payments including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and royalties on future product sales of injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent).

The Company is party to a Development, Manufacturing and Supply Agreement, or Supply Agreement, with Alkermes (through a subsidiary of Alkermes), pursuant to which Alkermes will (i) provide clinical and commercial bulk supplies of injectable meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls section of an NDA for injectable meloxicam. Pursuant to the Supply Agreement, Alkermes will supply the Company with such quantities of bulk injectable meloxicam formulation as shall be reasonably required for the completion of clinical trials of injectable meloxicam. During the term of the Supply Agreement, the Company will purchase its clinical and commercial supplies of bulk injectable meloxicam formulation exclusively from Alkermes, subject to certain exceptions, for a period of time.

(c) Litigation

The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations.

As part of the Gainesville Transaction, the Company acquired the rights to Zohydro ER®, which the Company licenses to its commercial partner Pernix Therapeutics, Inc., or Pernix, in the United States, and which is subject to ongoing intellectual property litigation and proceedings.

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Zohydro ER® has been subject to four paragraph IV certifications with Actavis plc, or Actavis, regarding the filing of Abbreviated NDAs, or ANDAs, with the FDA for a generic version of Zohydro ER®, the filing of a supplemental ANDA, one of the Company’s issued patents relating to a formulation of Zohydro ER®. These certification notices alleged that the three U.S. patents listed in the FDA’s Orange Book for Zohydro ER® will not be infringed by Actavis’ proposed products, are invalid and/or are unenforceable. In 2014 and 2015, the Company, by itself and through Daravita Limited (a subsidiary of Alkermes and the Company’s predecessor in interest), filed two suits against Actavis in the U.S. District Court for the District of Delaware based on the ANDAs and the sANDA, respectively. In February 2017, the District Court in the Actavis case ruled in the Company’s favor and enjoined Actavis from selling the proposed generic version of Zohydro ER®, which Actavis subsequently appealed to the U.S. Court of Appeals for the Federal Circuit. In October 2017, the Company filed suit against Actavis in the U.S. District Court for the District of Delaware based upon another issued patent relating to a formulation of Zohydro ER®. All litigation with Actavis settled in January 2018 via a multi-party settlement agreement among the Company, Pernix and Actavis, in which Actavis was granted a license to begin selling a generic version of Zohydro® ER on March 1, 2029, or earlier under certain circumstances.

(d) Leases

On January 1, 2017, the Company entered into a six-year lease for its Malvern, Pennsylvania facility that expires on December 31, 2022. In February 2017, the Company also entered into a three-year lease for office space in Dublin, Ireland that expires April 2020. The Company is also a party to operating leases for office equipment and storage. Rent expense includes rent as well as additional operating and tenant improvement expenses.

As of March 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the leases, are as follows:

	Lease payments
2018		411
2019		508
2020		408
2021		362
2022		374
Total	$	2,063

(e) Purchase Commitments

As of March 31, 2018, the Company had outstanding non-cancelable and cancelable purchase commitments in the aggregate amount of $27,228 related to inventory, capital expenditures and other goods and services, including pre-commercial/manufacturing scale-up and clinical activities.

(f) Certain Compensation and Employment Agreements

The Company has entered into employment agreements with certain of its named executive officers. As of March 31, 2018, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $734, from that date through calendar year 2018.

(14) Capital Structure

(a) Common Stock

The Company is authorized to issue 50,000,000 shares of common stock, with a par value of $0.01 per share.

Reflected below are the Company’s capital raises since its initial public offering, or IPO:

On March 12, 2014, the Company completed an initial public offering, or IPO, in which the Company sold 4,312,500 shares of common stock at $8.00 per share, resulting in gross proceeds of $34,500. In connection with the IPO, the Company paid $4,244 in underwriting discounts, commissions and offering costs, resulting in net proceeds of $30,256. Also in connection with the IPO, all of the outstanding shares of the Company’s Series A Redeemable Convertible Preferred Stock, including accreted dividends, and Bridge Notes, including accrued interest, were converted into common stock.

On July 7, 2015, the Company closed a private placement with certain accredited investors in which the Company sold 1,379,311 shares of common stock at a price of $11.60 per share, for net proceeds of $14,812. The Company paid the placement agents a fee equal to 6.0% of the aggregate gross proceeds from the private placement, plus reimbursement of certain expenses.

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On August 19, 2016, the Company closed an underwritten public offering in which the company sold 1,986,666 shares of common stock at a price per share of $7.50, for net proceeds of $13,367 after deducting underwriting commissions and offering expenses. 

On December 16, 2016, the Company closed an underwritten public offering in which the company sold 6,670,000 shares of common stock at a price per share of $6.00, for net proceeds of $36,888 after deducting underwriting commissions and offering expenses.

On December 29, 2017, the Company entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which the Company may sell from time to time, at its option, shares of its common stock, $0.01 par value per share, having an aggregate offering price of up to $40,000 through Cowen, as the placement agent. As of March 31, 2018, the Company did not have any sales of common stock under the Sales Agreement.

(b) Common Stock Purchase Agreement

On February 2, 2015, the Company entered into a Common Stock Purchase Agreement, or the 2015 Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, pursuant to which Aspire Capital was committed to purchase, at the Company’s election, up to an aggregate of $10,000 of shares of the Company’s common stock over the 24-month term of the 2015 Purchase Agreement. On the execution of the 2015 Purchase Agreement, the Company issued 96,463 shares of common stock to Aspire Capital with a fair value of $285, as consideration for entering in the 2015 Purchase Agreement. In addition, the Company incurred $253 of costs in connection with the 2015 Purchase Agreement, which, along with the fair value of the common stock, has been recorded as deferred equity costs. During 2016, the Company sold 1,143,940 shares of common stock under the 2015 Purchase Agreement for $7,796. The agreement expired in February 2017.

On March 2, 2018, the Company entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth in the Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate of $20,000 of  shares of the Company’s common stock over the approximately 30-month term of the Purchase Agreement. On the execution of the Purchase Agreement, the Company agreed to issue 33,040 shares of common stock to Aspire Capital as consideration for entering into the Purchase Agreement. As of March 31, 2018, the Company sold 350,000 shares of common stock under the Purchase Agreement for proceeds of $3,514.

(c) Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.01 per share. As of March 31, 2018, no preferred stock was issued or outstanding.

(d) Warrants

As of March 31, 2018, the Company had the following warrants outstanding to purchase shares of the Company’s common stock:

Number of Shares	Exercise Price per Share		Expiration Date
140,000	$	12.00	March 2019
350,000	$	19.46	April 2022
294,928	$	3.28	April 2022
348,664	$	8.60	November 2024

The warrants to purchase 140,000 and 348,664 shares related to Aegis Capital Corporation and Athyrium, respectively, are equity classified.

The warrants to purchase 350,000 and 294,928 shares related to Alkermes and OrbiMed, respectively, are liability classified since they contain a contingent net cash settlement feature. The fair value of both warrants will be remeasured through settlement or expiration with changes in fair value recognized as a period charge within the statement of operations.

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The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for these liability classified warrants.

	March 31, 2018			December 31, 2017
Fair value	$	4,179		$	3,406
Expected dividend yield		—	%		—	%
Expected volatility	74		%	75		%
Risk-free interest rates	2.48		%	2.09		%
Remaining contractual term	4.00 years			4.25 years

(15) Comprehensive Loss

The Company’s comprehensive loss is shown on the Consolidated Statements of Operations and Comprehensive Loss as of March 31, 2018, and is comprised of net unrealized gains and losses on the Company’s available-for-sale securities. The total of comprehensive loss for the three months ended March 31, 2018 and 2017 was $12,455 and $8,144, respectively. There was no tax effect of other comprehensive loss for the three months ended March 31, 2018. The tax effect of other comprehensive loss for the three months ended March 31, 2017 was $19.

(16) Stock-Based Compensation

The Company established the 2008 Stock Option Plan, or the 2008 Plan, which allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants and advisors. As of March 31, 2018, no stock appreciation rights have been issued. Subsequent to adoption, the 2008 Plan was amended to increase the authorized number of shares available for grant to 444,000 shares of common stock. In October 2013, the Company established the 2013 Equity Incentive Plan, or the 2013 Plan, which allows for the grant of stock options, stock appreciation rights and stock awards for a total of 600,000 shares of common stock. In June 2015, the Company’s shareholders approved the Amended and Restated Equity Incentive Plan, or the A&R Plan, which amended and restated the 2013 Plan and increased the aggregate amount of shares available for issuance to 2,000,000. On December 1^st of each year, pursuant to the “Evergreen” provision of the A&R Plan, the number of shares available under the plan may be increased by the board of directors by an amount equal to 5% of the outstanding common stock on December 1^st of that year. In December 2017 and 2016, the number of shares available for issuance under the A&R Plan was increased by 956,341 and 619,181, respectively. The total number of shares authorized for issuance under the A&R plan as of March 31, 2018 is 4,036,737. In May 2018, the Company’s shareholders approved the 2018 Amended and Restated Equity Incentive Plan, which amended and restated the A&R Plan to increase the aggregate amount of shares available for issuance to 7,036,737.

Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of March 31, 2018, 254,420 shares and 174 shares are available for future grants under the A&R Plan and 2008 Plan, respectively.

The weighted average grant-date fair value of the options awarded to employees during the three months ended March 31, 2018 and 2017 was $6.08 and $5.29, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions:

	March 31,
	2018		2017
Range of expected option life	6 years		6 years
Expected volatility	74.01% - 74.60%		84.71%
Risk-free interest rate	2.32 - 2.73%		2.05 - 2.17%
Expected dividend yield		—		—

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The following table summarizes stock option activity during the three months ended March 31, 2018:

	Number of shares			Weighted average exercise price		Weighted average remaining contractual life
Balance, December 31, 2017		3,594,875		$	7.17	7.1 years
Granted		713,226			9.16
Exercised		(14,575	)		4.49
Expired/forfeited/cancelled		(46,805	)		8.51
Balance, March 31, 2018		4,246,721		$	7.50	7.3 years
Vested		2,213,374		$	6.82	5.7 years
Vested and expected to vest		4,246,721		$	7.50	7.3 years

Included in the table above are 961,750 options granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).

During the year ending December 31, 2016, the Company adopted ASU 2016-09 and elected to account for forfeitures as they occur.

The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2018.

	Number of shares
Balance, December 31, 2017		270,593
Granted		500,120
Vested and settled		(35,025	)
Expired/forfeited/cancelled		(9,366	)
Balance, March 31, 2018		726,322
Expected to vest		726,322

Included in the table above are 44,500 time-based RSUs granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).

In March 2018, the Company granted 240,224 performance-based RSUs, which may vest based on attaining 2018 financial, clinical and operational goals, as well as 259,896 time-based RSUs, which vest over four years.

Stock-based compensation expense for the three months ended March 31, 2018 and 2017 was $1,584 and $892, respectively.

As of March 31, 2018, there was $14,870 of unrecognized compensation expense related to unvested options and time-based RSUs that are expected to vest and will be expensed over a weighted average period of 2.6 years. As of March 31, 2018, there was $2,671 of unrecognized compensation expense related to unvested performance-based RSUs and will be expensed when the performance criteria are met.

The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. As of March 31, 2018, the aggregate intrinsic value of the vested and unvested options was $9,522 and $5,746, respectively.

(17) Segment Reporting

The Company operates through two business divisions that are treated as separate financial segments: an Acute Care segment and a revenue-generating CDMO segment. The Acute Care segment is primarily focused on developing innovative products for hospital and related settings, and the CDMO segment leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. Acute Care has no revenue, and its costs consist primarily of expenses incurred in conducting the Company’s clinical and preclinical studies, acquiring clinical trial materials, regulatory activities, personnel costs and pre-commercialization of meloxicam. CDMO revenue streams are derived from manufacturing, royalty revenues, as well as CDMO’s research and development services performed for commercial partners.

The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note 3). The Company evaluates performance of its reportable segments based on revenue and operating income (loss). The Company does not allocate interest income, interest expense or income taxes to its operating segments.

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The following table summarizes segment information as of and for the three months ended March 31, 2018:

	For the Three Months Ended March 31,
	2018			2017
Revenues:
CDMO	$	19,542		$	18,742
Acute Care		—			—
Total	$	19,542		$	18,742
Operating income (loss):
CDMO	$	6,566		$	6,199
Acute Care		(19,413	)		(13,501	)
Total	$	(12,847	)	$	(7,302	)
Depreciation and amortization:
CDMO	$	1,819		$	1,837
Acute Care		43			5
Total	$	1,862		$	1,842
Capital expenditures:
CDMO	$	329		$	1,530
Acute Care		1,325			214
Total	$	1,654		$	1,744

	March 31,		December 31,
	2018		2017
Total assets:
CDMO	$	80,300	$	78,136
Acute Care		98,153		108,090
Total	$	178,453	$	186,226

(18)  Revenue Recognition

Effective January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method applied to contracts existing as of January 1, 2018.  Results for reporting periods beginning after January 1, 2018 are presented under the new guidance while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance.  See Note 3 for additional information on the Company’s revenue recognition policies.

The Company uses the practical expedient to not account for significant financing components because the period between recognition and collection does not exceed one year in any contract.

Upon adoption, the Company recorded a decrease of $2,818 to the opening balance of accumulated deficit as of January 1, 2018. This adjustment resulted from a change in revenue recognition associated with a variable portion of certain of its royalty revenue.  Under the new accounting standard, estimated royalty revenue to be received in the future that is deemed predominantly related to product sales rather than the license for intellectual property, is included as a component of the product sale transaction consideration to the extent such consideration is not probable to significant reversal.  Prior to adoption of the new guidance, the Company recognized this royalty revenue in the period the products were sold by the commercial partner.

The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09 were as follows:

	Balance at December 31, 2017		Adoption of ASU 2014-09			Balance at January 1, 2018
Contract asset	$	—	$	3,755		$	3,755
Deferred income taxes		18,573		(937	)		17,636
Total shareholders' equity		28,848		(2,818	)		26,030

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The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed consolidated balance sheet was as follows:

	For the Three Months Ended March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Revenue	$	17,789		$	1,753		$	19,542
Income tax benefit		2,790			(437	)		2,353
Net loss		(13,771	)		1,316			(12,455	)

	March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Contract assets	$	—		$	5,508		$	5,508
Deferred income taxes		21,363			(1,374	)		19,989
Total assets		174,319			4,134			178,453
Accumulated deficit		(125,119	)		4,134			(120,985	)
Total shareholders' equity		20,442			4,134			24,576
Total liabilities and shareholders' equity		174,319			4,134			178,453

Contract assets represent revenue recognized for performance obligations completed before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract assets were $5,508 and $3,755 at March 31, 2018 and January 1, 2018, respectively. Generally, the contract assets balance is impacted by the recognition of additional contract assets, offset by amounts invoiced to customers or actual net product sale amounts reported by the commercial partner for the period. For the three months ended March 31, 2018, actual net product sale amounts reported by the Company’s commercial partner exceeded estimates of royalty amounts attributed to manufactured product shipped as of January 1, 2018 for the related arrangements by approximately $817. 

The following table presents changes in the Company’s contract assets for the three months ended March 31, 2018:

Contract asset, beginning of year	$	3,755
Change in estimate arising from changes in transaction price		817
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional		(4,572	)
Contract assets recognized		5,508
Contract asset, end of period	$	5,508

The following table disaggregates revenue by business segment and timing of revenue recognition:

	For the Three Months Ended March 31, 2018
	Point in time		Overtime		Total
CDMO	$	19,413	$	129	$	19,542
Acute Care		—		—		—
Revenue		19,413		129		19,542

Adoption of ASU 2014-09 did not require capitalization of any costs to obtain or fulfill contracts. In general, the Company’s payment terms for manufacturing revenue and research and development services is 30 days.  Royalty revenue is recorded to accounts receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment terms are generally 45 days after quarter end.  Based on the adoption of ASU 2014-09, the timing difference between recognition of certain royalty revenues as a contract asset and cash receipt is increased by an estimated 90 days.

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(19) Related Party Transactions

A Non-Executive Director of the Company’s Irish subsidiary is a Managing Director and a majority shareholder of HiTech Health Ltd, or HiTech Health, a consultancy firm for the biotech, pharmaceutical and medical device industry. Since 2016, HiTech Health has provided the Company with certain consulting services and in November 2017 both parties entered into a Service Agreement to engage in regulatory project support and consultancy. In consideration for such services, the Company recorded $109 for the three months ended March 31, 2018.  A portion of the amount relates to consultancy services provided by the Non-Executive Director.

(20)   Retirement Plan

The Company has a voluntary 401(k) Savings Plan (the 401(k) Plan) in which all employees are eligible to participate. The Company’s policy is to match 100% of the employee contributions up to a maximum of 5% of employee compensation. Total Company contributions to the 401(k) plan for the three months ended March 31, 2018 and 2017 were $390 and $343,  respectively.

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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the interim unaudited financial statements contained in Part I, Item 1 of this quarterly report, and the audited financial statements and notes thereto for the year ended December 31, 2017 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our annual report on Form 10-K filed with the SEC on March 2, 2018. As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company” or “Recro” refer to Recro Pharma, Inc. and its consolidated subsidiaries.

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements. We may, in some cases, use terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

These forward-looking statements in this quarterly report on Form 10-Q include, among other things, statements about:

• our estimates regarding expenses, future revenue, capital requirements and timing and availability of and the need for additional financing;

• our ability to obtain and maintain regulatory approval of intravenous, or IV, meloxicam and our product candidates, and the labeling under any approval that we may obtain;

• our ability to successfully commercialize IV meloxicam or our other product candidates, upon regulatory approval;

• our ability to generate sales and other revenues from IV meloxicam or any of our other product candidates, once approved, including setting an acceptable price for and obtaining adequate coverage and reimbursement of such products;

• the results, timing and outcome of our clinical trials of IV meloxicam or our other product candidates, and any future clinical and preclinical studies;

• our ability to raise future financing and attain profitability for continued development of our business and our product candidates and to meet required debt payments, and any milestone payments owing to Alkermes plc, or Alkermes, or our other licensing and collaboration partners;

• our ability to comply with the regulatory schemes applicable to our business and other regulatory developments in the United States and foreign countries;

• our ability to operate under increased leverage and associated lending covenants;

• the performance of third-parties upon which we depend, including third-party contract research organizations, and third-party suppliers, manufacturers, distributers and logistics providers;

• our ability to obtain and maintain patent protection and defend our intellectual property rights against third-parties;

• our ability to maintain our relationships and contracts with our key commercial partners;

• our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive officers;

• our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including Good Manufacturing Practice, or cGMP, compliance and U.S. Drug Enforcement Agency, or DEA, compliance; and

• the effects of changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities and changes in the tax laws.

Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

You should also read carefully the factors described in the “Risk Factors” included in Part II, Item 1A of this Quarterly Report and Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the SEC on March 2, 2018 to better understand significant risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this report and you should not place undue reliance on any forward-looking statements.

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Overview

We are a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating CDMO division. Each of these divisions are deemed to be reportable segments for financial reporting purposes.

Our Acute Care segment is primarily focused on developing and commercializing innovative products for hospital and related acute care settings. Our lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed three Phase III clinical trials for the management of moderate to severe pain, consisting of two pivotal efficacy trials and a large double-blind Phase III safety trial, as well as other safety studies. Overall, the total new drug application, or NDA, program included over 1,400 patients. In late July 2017, we submitted a NDA to the U.S. Food and Drug Administration, or FDA, for IV meloxicam 30mg for the management of moderate to severe pain. The FDA has accepted the NDA for review and set a date for decision on the NDA under the Prescription Drug User Fee Act, or PDUFA, of May 26, 2018. Our Acute Care segment has no revenue and our costs consist primarily of expenses incurred in conducting our clinical trials and preclinical studies, manufacturing scale-up, regulatory activities, pre-commercialization of meloxicam and personnel costs.

Our CDMO segment leverages formulation expertise to develop and manufacture pharmaceutical products using proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. These collaborations result in revenue streams including manufacturing, royalties, and research and development, which support continued operations for our CDMO segment and have contributed excess cash flow to be used for our research and development activities in our Acute Care segment. We operate a 97,000 square foot, DEA-licensed manufacturing facility in Gainesville, Georgia and we currently develop and/or manufacture the following key products with our commercial partners: Ritalin LA®, Focalin XR®, Verelan PM®, Verelan SR®, Verapamil PM, Verapamil SR and Zohydro ER®, as well as supporting development stage products. Our CDMO segment’s revenue streams are derived from manufacturing, and royalty revenues, as well as our research and development of services performed for commercial partners.

We have incurred losses and generated negative cash flows from operations since inception, and expect to continue to incur significant and increasing operating losses for the foreseeable future. Substantially all of our operating losses resulted from costs incurred in connection with our development programs, including our non-clinical and formulation development activities, manufacturing, clinical trials and pre-commercialization activities. We have used revenue generated by our CDMO segment primarily to fund operations at our Gainesville, Georgia manufacturing facility, to make payments under our previous credit facility and to partially fund our development and pre-commercialization activities of our Acute Care segment. We believe our CDMO segment’s revenue will continue to contribute cash for general corporate purposes that may, to some extent, reduce the amount of external capital needed to fund development and commercial operations. We expect to incur increasing expenses over the next several years to commercialize IV meloxicam, if approved, including continued pre-commercialization and commercialization activities for IV meloxicam, and to develop our other current and future product candidates.

On April 10, 2015, we completed the acquisition from Alkermes of certain assets, including the worldwide rights to injectable meloxicam and the development, formulation and manufacturing business that comprised our CDMO segment, which we refer to as the Gainesville Transaction, which transformed our business through the addition of a revenue-generating business and the increase in our workforce as a result of the addition of the employees at our Gainesville, Georgia manufacturing facility. The consideration paid consisted of $50.0 million cash, a $4.0 million working capital adjustment and a seven-year warrant to purchase 350,000 shares of our common stock at an exercise price of $19.46 per share. In addition, we may be required to pay up to an additional $125.0 million in milestone payments including $45.0 million upon regulatory approval of IV meloxicam, as well as net sales milestones and a royalty percentage of future product net sales related to IV meloxicam.

We funded the up-front payment of the Gainesville Transaction with borrowings under our previous credit facility with OrbiMed Royalties, II, LP, or OrbiMed, and cash on hand. Pursuant to the credit facility with OrbiMed, we issued OrbiMed a warrant to purchase an aggregate of 294,928 shares of our common stock at an exercise price of $3.28 per share, subject to certain adjustments.

In November 2017, we entered into our Credit Agreement with Athyrium Opportunities III Acquisition LP, or Athyrium, pursuant to which we drew $60.0 million in an initial term loan and have the ability to draw upon two additional tranches of terms loans, each in the aggregate original principal amount of $20.0 million, subject to certain timing and milestone restrictions.  We used the proceeds from the initial term loan to repay in full all outstanding indebtedness and transaction fees under the previous credit facility with OrbiMed. The interest rate under the credit agreement with Athyrium is equal to three-month LIBOR plus 9.75%, with a 1.0% LIBOR floor. Pursuant to the credit agreement with Athyrium, we issued to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP, warrants to purchase an aggregate of 348,664 shares of our common stock at an exercise price of $8.6043 per share, subject to certain adjustments.

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Financial Overview

Revenues

During the three months ended March 31, 2018 and 2017 we recognized revenues in three categories: manufacturing revenue, royalty and research and development revenue. All revenue is generated from our CDMO segment.

Manufacturing revenue

We recognize manufacturing revenue from the sale of products we manufacture for our commercial partners. Manufacturing revenues are recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration we expect to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments.

Royaltyrevenue

We recognize royalty or profit sharing revenue, collectively referred to as royalty revenue, related to the sale of products by our commercial partners that incorporate our technologies. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue when the related sales occur by the commercial partner.  For arrangements that include sales-based royalties and the license is not deemed to be the predominant item to which the royalties relate, we recognize revenue when the performance obligation to which the royalty has been allocated has been satisfied, which is upon transfer of control of a product to a customer.  In this case, significant judgement is used in the estimation of these royalties based on historical customer pricing and deductions and is partially constrained due to items that are outside of our control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by our commercial partners.

Research and development revenue

Research and development revenue consists of funding that compensates us for formulation, and preparation of pre-clinical and clinical testing drug product materials prepared by our CDMO segment under research and development arrangements with commercial partners. We generally bill our commercial partners under research and development arrangements using a full-time equivalent or hourly rate, plus direct external costs, if any. Revenues related to research and development are generally recognized as the related services or activities are performed using the output method and in accordance with the contract terms. To the extent that the agreements specify services are to be performed on a fixed basis, revenues are recognized consistent with the pattern of the work performed.

In agreements which specify milestones, we evaluate whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is recognized at a point in time.  Non-refundable milestone payments related to arrangements under which we have continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within our control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received.

Research and Development Expenses

Research and development expenses currently consist primarily of costs incurred in connection with the development of injectable meloxicam and other pipeline activities. These expenses consist primarily of:

• expenses incurred under agreements with contract research organizations, investigative sites and consultants that conduct our clinical trials and a substantial portion of our preclinical studies;

• the cost of acquiring and manufacturing clinical trial materials and manufacturing services;

• costs related to facilities, depreciation and other allocated expenses;

• acquired in process research and development;

• costs associated with non-clinical and regulatory activities;

• salaries and related costs for personnel in research and development and regulatory functions;

• costs associated with pre-commercialization activities for IV meloxicam, including manufacturing costs of pre-commercial inventory; and

• costs related to scale up and validation for IV meloxicam.

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The majority of our external research and development costs relate to clinical trials, manufacturing of drug supply for pre-commercial products, analysis and testing of product candidates and patent costs. Costs related to facilities, depreciation and support are not charged to specific programs.

The successful development of our product candidates is highly uncertain and subject to a number of risks, including, but not limited to:

• the costs, timing and outcome of regulatory review of a product candidate;

• the duration of clinical trials, which varies substantially according to the type, complexity and novelty of the product candidate;

• substantial requirements on the introduction of pharmaceutical products imposed by the FDA and comparable agencies in foreign countries, which require lengthy and detailed laboratory and clinical testing procedures, sampling activities and other costly and time-consuming procedures;

• the possibility that data obtained from pre-clinical and clinical activities at any step in the testing process may be adverse and lead to discontinuation or redirection of development activity or may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval;

• risk involved with development of manufacturing processes, FDA pre-approval inspection practices and successful completion of manufacturing batches for clinical development and other regulatory purposes;

• the emergence of competing technologies and products and other adverse market developments, which could impede our commercial efforts; and

• the other risks disclosed in the section titled “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

Development timelines, probability of success and development costs vary widely. As a result of the uncertainties discussed above, we anticipate that we will make determinations as to which additional programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical data of each product candidate, as well as ongoing assessments of such product candidate’s commercial potential and available capital resources. Accordingly, we cannot currently estimate with any degree of certainty the amount of time or costs that we will be required to expend in the future on our product candidates to complete current or future clinical or pre-commercial stages prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of any approvals, we are currently unable to estimate precisely when, if ever, any of our other product candidates will generate revenues and cash flows.

We expect our research and development costs to relate to injectable meloxicam for the foreseeable future as we advance this product candidate through the commercialization scale-up, clinical and other activities. We also expect to have expenses as we initiate clinical trials and related work for our other product candidates. We may elect to seek out collaborative relationships in order to provide us with a diversified revenue stream and to help facilitate the development and commercialization of our product candidate pipeline. We expect our research and development costs to continue to increase as we continue clinical and pre-commercialization manufacturing activities for IV meloxicam, and engage in pipeline development activities.

In addition, research and development expenses consist of costs incurred by our CDMO segment for its product and formulation development activities, including regulatory support. We expense research and development costs as incurred. Advanced payments for goods and services that will be used in future research and development activities are initially recorded as prepaid expenses and expensed as the activity is performed or when the goods have been received.

General and Administrative Expenses

General and administrative expenses consist principally of salaries and related costs for personnel in executive, pre-commercial and finance and information technology functions. General and administrative expenses also include professional fees for legal, including patent-related expenses, consulting, auditing and tax services, and stock compensation expense.

We expect our general and administrative expenses to continue to increase as we build our Acute Care commercialization team and engage in pre-commercialization IV meloxicam marketing, sales, market access and medical affairs activities. In addition, we will continue to incur costs relating to our operations as a public company, including increased headcount and increased salary, consulting, legal, patent and compliance, accounting, insurance and investor relations costs.

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Amortization of Intangible Assets

We recognize amortization expense related to the intangible asset for our contract manufacturing relationships on a straight-line basis over an estimated useful life of six years. The intangible asset related to injectable meloxicam represents in process research and development, or IPR&D, which is considered an indefinite-lived intangible asset that is assessed for impairment annually or more frequently if impairment indicators exist.

Change in Fair Value of Contingent Consideration

In connection with the acquisition of injectable meloxicam in the Gainesville Transaction, we are required to pay up to an additional $125.0 million in milestone payments, including $45.0 million upon regulatory approval of IV meloxicam, as well as net sales milestones and a royalty percentage of future product net sales related to IV meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). The estimated fair value of the initial $54.6 million payment obligation was recorded as part of the purchase price for the Gainesville Transaction. We have since reevaluated and as of March 31, 2018 recorded a $84.9 million payment obligation, representing the estimated probability adjusted fair value, and we expect, at a minimum, the current portion of $34.0 million will further increase by approximately $20.0 million as we approach the PDUFA date, and potential approval of IV meloxicam, which will trigger the $45.0 million milestone payment due to Alkermes. Each reporting period, we revalue this estimated obligation with changes in fair value recognized as a non-cash operating expense or income.

Change in Fair Value of Warrants

We have classified as liabilities certain warrants outstanding which contain a contingent net cash settlement feature, upon a change in control. The fair value of these warrants is remeasured through settlement or expiration with changes in fair value recognized as a period charge within the Consolidated Statements of Operations and Comprehensive Loss.

Interest Expense, net

Interest expense, net for the three months ended March 31, 2018 was a result of interest expense incurred on our Athyrium senior secured term loans and the amortization of the related financing costs, net of interest income on cash equivalents and short-term investments. Interest expense for the three months ended March 31, 2017 was a result of interest expense incurred on our OrbiMed senior secured term loan and the amortization of the related financing costs.

Net Operating Losses and Tax Carryforwards

As of December 31, 2017, we had approximately $9.0 million of federal net operating loss carryforwards. We also had federal and state research and development tax credit carryforwards of $3.4 million available to offset future taxable income. U.S. tax laws limit the time during which these carryforwards may be utilized against future taxes. These federal and state net operating loss and federal and state tax credit carryforwards will begin to expire at various dates beginning in 2028, if not utilized. Based on our projected future taxable income we expect to be able to utilize all federal and state net operating losses. We have also generated foreign net operating loss carryforwards in Ireland. We currently do not believe it is more likely than not we will use any of these net operating losses and as a result have recorded a full valuation allowance against the deferred tax asset related to the losses.

Under the Tax Reform Act of 1986, or the Act, the utilization of a corporation’s net operating loss and research and development tax credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any unused annual limitation may be carried forward to future years for the balance of the carryforward period. We determined that we have experienced ownership changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past financings; accordingly, our ability to utilize the aforementioned carryforwards will be limited. Although the carryforwards will be limited, we have determined that none of the net operating losses will expire prior to being utilized as a result of the changes. In addition, state net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward respectively. In addition, since we will need to raise substantial additional funding to finance our operations, we may undergo further ownership changes in the future, including changes to our organizational structure relating to foreign operations, purchases, sales and licenses, which could further limit our ability to use net operating loss carryforwards. As a result, if we generate taxable income, our ability to use some of our net operating loss carryforwards to offset U.S. federal and state taxable income may be subject to limitations, which could result in increased future tax liabilities to us.

In December 2017, the federal government enacted numerous amendments to the Internal Revenue Code of 1986 pursuant to the Tax Cuts and Jobs Act, or the Tax Act.  The Tax Act will impact our income tax expense/(benefit) from operations in future periods. The Tax Act resulted in the following impacts to us:

• Our federal statutory income tax rate was reduced from 34% to 21% for 2018 and tax years following.

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•Our results for the fourth quarter of 2017 included a one-time net expense of $7.9 million, as a result of remeasuring our deferred tax balances to the new statutory rate.

•We will be able to claim an immediate deduction for investments in qualified fixed assets acquired and placed in service beginning September 27, 2017 through 2022.  This provision phases out through 2026.

Results of Operations

Comparison of the Three Months Ended March 31, 2018 and 2017

	Three Months Ended March 31,
	2018			2017
	(amounts in thousands)
Revenue	$	19,542		$	18,742
Operating expenses:
Cost of sales (excluding amortization of intangible assets)		10,490			10,498
Research and development		8,442			7,763
General and administrative		9,518			4,032
Amortization of intangible assets		646			646
Change in warrant valuation		773			291
Change in contingent consideration valuation		2,520			2,814
Total operating expenses		32,389			26,044
Operating loss		(12,847	)		(7,302	)
Other income (expense):
Interest expense, net		(1,961	)		(1,078	)
Loss before income taxes		(14,808	)		(8,380	)
Income tax benefit		2,353			293
Net loss	$	(12,455	)	$	(8,087	)

Revenue and costs of sales. Our revenues were $19.5 million and $18.7 million and cost of sales were $10.5 million and $10.5 million for the three months ended March 31, 2018 and 2017, respectively. The increase of $0.8 million in revenue was primarily due to the net impact of royalties recognized from one of our commercial partners after the adoption of Accounting Standards Update, or ASU, No. 2014-09, or ASU 2014-09. Cost of sales remained constant compared to prior year.

Research and Development. Our research and development expenses were $8.4 million and $7.8 million for the three months ended March 31, 2018 and 2017, respectively. The increase of $0.6 million was primarily due to an increase in pre-commercialization manufacturing costs for IV meloxicam, an increase in salaries and benefits expense due to increased headcount and a modest increase in development costs for other pipeline products.  These increases in research and development costs were offset by lower IV meloxicam clinical trial expenses.

General and Administrative. Our general and administrative expenses were $9.5 million and $4.0 million for the three months ended March 31, 2018 and 2017, respectively. The increase of $5.5 million was primarily due to building of the commercial team and its related costs.

Amortization of Intangible Assets. Amortization expense was $0.6 million for each of the quarters ended March 31, 2018 and 2017, respectively, which was exclusively related to the amortization of our CDMO royalties and contract manufacturing relationships intangible asset over its estimated useful life.

Interest Expense, net. Interest expense, net was $2.0 million and $1.1 million during the three months ended March 31, 2018 and 2017, respectively. The increase of $0.9 million was primarily due to the higher principal balance on our Athyrium senior secured term loan and amortization of the related financing costs, which was partially offset by a lower interest rate on our Athyrium senior secured term loan versus our previous loan with OrbiMed.

Income Tax Benefit. Income tax benefit was $2.4 million and $ 0.3 million for the three months ended March 31, 2018 and 2017, respectively, related exclusively to our U.S. operations. The increase of $1.8 million was primarily due to increased losses in the U.S. We believe that it is more likely than not that the deferred income tax assets associated with our foreign operations will not be realized, and as such, there is a full valuation allowance against our foreign deferred tax assets.

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Operating Income (Loss) per Segment.

CDMO Segment-

Our CDMO segment’s revenues were $19.5 million and $18.7 million in the three months ended March 31, 2018 and 2017, respectively. The increase of $0.8 million in revenue was primarily due to the net impact of royalties recognized from one of our commercial partners after the adoption of ASU 2014-09. Cost of sales remained constant compared to prior year.

Our CDMO segment’s operating expenses (including cost of sales) increased by $0.4 million, from $1.4 million in the three months ended March 31, 2017 to $1.8 million in the three months ended March 31, 2018. Research and development expenses increased by $0.2 million and general and administration expenses increased by $0.2 million. All of the above contributed to CDMO’s operating income of $6.6 million for the three months ended March 31, 2018, which included non-cash charges of $1.8 million for depreciation and amortization and $0.3 million for stock-based compensation.

Acute Care Segment-

Our Acute Care segment’s operating expenses increased $5.7 million from $10.4 million in the three months ended March 31, 2017 to $16.1 million in the three months ended March 31, 2018. Research and development expenses increased $0.5 million as a result of increased IV meloxicam pre-commercialization manufacturing costs and increased headcount, which was partially offset by a decrease in our IV meloxicam clinical trial expenses. General and administrative costs increased by $5.2 million as a result of increased headcount and increased pre-commercialization marketing expenses. Non-cash charges related to the warrant valuation increased $0.5 million and contingent consideration decreased by $0.3 million. All of the above contributed to our Acute Care segment’s operating loss of $19.3 million for the three months ended March 31, 2018, which also included non-cash charges of $1.4 million for stock-based compensation, depreciation and amortization.

Liquidity and Capital Resources

As of March 31, 2018, we had $51.3 million in cash and cash equivalents and short-term investments.

Since inception through March 31, 2018, we have financed our product development, operations and capital expenditures primarily from sales of equity and debt securities, including sales of our common stock with net proceeds of $120.0 million, and term loans made under our previous and existing credit facilities, including our current $100.0 million credit facility with Athyrium. Revenues from our CDMO segment are used primarily to fund operations at our Gainesville, Georgia manufacturing facility, to make payments under our credit facility and to partially fund the development and pre-commercialization activities of our Acute Care segment. During the three months ended March 31, 2018, our capital expenditures were $1.7 million.

We will need to raise substantial additional funds in order to fund the payments which may become due, including milestone payments owed to Alkermes or other licensing partners, to continue our clinical trials of our product candidates, to commercialize any approved product candidates or technologies and to enhance our sales and marketing efforts for additional products we may acquire. Insufficient funds may cause us to delay, reduce the scope of or eliminate one or more of our development, commercialization or expansion activities. Our future capital needs and the adequacy of our available funds will depend on many factors, including the cost of clinical studies and other actions needed to obtain regulatory approval of our products in development, the timing of approval of IV meloxicam, the level of market acceptance of IV meloxicam and the costs of commercialization activities for IV meloxicam, if approved, the continued profitability of our CDMO segment, and our ability to access additional tranches under our Credit Agreement with Athyrium. We may raise such additional funds through debt refinancing, bank or other loans, through strategic research and development, licensing, including out-licensing activities, and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely impact our growth plans and our financial condition or results of operations. Additional debt or equity financing, if available, may be dilutive to the holders of our common stock and may involve significant cash payment obligations and covenants that restrict our ability to operate our business or access to capital.

On March 7, 2015, in connection with the Gainesville Transaction, we, through a wholly owned subsidiary, entered into a credit agreement with OrbiMed. Pursuant to the credit agreement, OrbiMed provided us with a term loan in the original principal amount of $50.0 million on April 10, 2015, which amount was used to fund the Gainesville Transaction. On November 17, 2017, we entered into our credit agreement with Athyrium, pursuant to which we drew $60.0 million in an initial term loan and have the ability to draw upon two additional tranches of terms loans, each in the aggregate original principal amount of $20.0 million.  Pursuant to the terms of the credit agreement, we may draw upon the second $20.0 million tranche on or before December 31, 2018, provided that we receive regulatory approval for IV meloxicam and retain at least $20.0 million in unrestricted cash following payment of the $45.0 million milestone payment to Alkermes. We may draw upon the final $20.0 million tranche on or prior to March 31, 2020, provided that we have drawn on the second tranche and have achieved net sales for IV Meloxicam of $20.0 million in the most recent trailing twelve-month period. We used the proceeds from the $60.0 million initial term loan to (i) repay in full all outstanding indebtedness under our credit facility with OrbiMed of approximately $31.7 million, which included the remaining debt principal balance of $27.3 million and early termination charges of $4.4

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million and (ii) pay transaction fees associated with the credit facility with Athyrium of approximately $4.2 million. As of March 31, 2018, we had $60.0 million outstanding principal under our Credit Agreement with Athyrium.

Sources and Uses of Cash

Cash used in operations was $14.8 million and $7.1 million for the three months ended March 31, 2018 and 2017, respectively, which represents our operating losses less our stock-based compensation, depreciation, non-cash interest expense, changes in fair value of warrants and contingent consideration and amortization of intangibles, as well as changes in operating assets and liabilities.

Cash used in investing activities was $3.1 million and $37.9 million for the three months ended March 31, 2018 and 2017, respectively, and reflected cash used for the purchase of short-term investments offset by maturities/redemption of investments and for the purchase of property and equipment. Our short-term investments are classified as available for sales securities with maturities of less than one year.

There was $3.2 million of cash provided by financing activities in the three months ended March 31, 2018 from net proceeds of $3.5 million from the sale of shares of common stock through our Common Stock Purchase Agreement with Aspire Capital and proceeds of $0.1 million from exercise of options, which was partially offset by deferred financing costs of $0.3 million from the Athyrium transaction. Our future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:

• the timing and outcome of the FDA’s review of an NDA for IV meloxicam;

• the timing and outcome of our Phase IIIb clinical trials for IV meloxicam;

• the extent to which the FDA may require us to perform additional preclinical studies, clinical trials or pre-commercial manufacturing of injectable meloxicam or our other product candidates;

• the timing of the Gainesville Transaction regulatory milestone payments and other contingent consideration;

• the costs of our commercialization activities, if our product candidates are approved by the FDA;

• the cost of manufacturing scale-up, acquiring drug product and other capital equipment for our product candidates;

• the level of market acceptance of IV meloxicam, if approved;

• the scope, progress, results and costs of development for our other product candidates;

• the cost, timing and outcome of regulatory review of our other product candidates;

• the extent to which we in-license, acquire or invest in products, businesses and technologies;

• the timing and extent of our manufacturing and capital expenditures related to our CDMO segment;

• our ability to maintain our relationships and contracts with our commercial partners;

• our ability to comply with stringent U.S. & foreign government regulation in the manufacture of pharmaceutical products, including cGMP and U.S. DEA requirements;

• the extent to which we choose to establish collaboration, co-promotion, distribution or other similar agreements for product candidates;

• our ability to access additional tranches of term loans under our credit agreement with Athyrium;

• our ability to raise additional funds through equity or debt financings;

• the costs of preparing, submitting and prosecuting patent applications and maintaining, enforcing and defending intellectual property claims; and

• the effect of any changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities and changes in tax laws.

We might use existing cash and cash equivalents on hand, additional debt, equity financing or out-licensing revenue or a combination thereof to fund our operations or product acquisitions. If we increase our debt levels, we might be restricted in our ability to raise additional capital and might be subject to financial and restrictive covenants. Our shareholders may experience dilution as a result of the issuance of additional equity or debt securities. This dilution may be significant depending upon the amount of equity or debt securities that we issue and the prices at which we issue any securities.

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Contractual Commitments

The table below reflects our contractual commitments as of March 31, 2018:

	Payments Due by Period (in 000s)
Contractual Obligations	Total		Less than 1 year		1-3 years		3-5 years		More than 5 years
Long-Term Debt Obligations (1):
Athyrium Debt	$	60,600	$	—	$	—	$	60,600	$	—
Interest on Debt	$	34,439		7,439		14,897		12,103		—
Purchase Obligations (2):	$	27,228		21,283		3,445		—		—
Operating Leases (3)	$	2,063		543		875		645		—
Other Long-Term Liabilities:
Other License Commitments and Milestone payments (4), (5)	$	56,905		15		65		130		395
Alkermes Payments (6)	$	125,000		—		—		—		—
Employment Agreements (7)	$	734		734		—		—		—
Other Non-Current Liabilities (8)	$	110		—		110		—		—
Total Contractual Obligations	$	307,079	$	30,014	$	19,392	$	73,478	$	395

(1) The long-term debt obligations consist of principal, an exit fee of 1% of the principal, and interest on the initial $60.0 million of our $100 million credit facility with Athyrium as of March 31, 2018. The debt bears interest at a rate of LIBOR plus 9.75% per annum. Due to fluctuations of the future LIBOR interest rate, it has been set at the rate as at March 29, 2018 to calculate the obligation. In accordance with U.S. GAAP, the future interest obligations are not recorded on our Consolidated Balance Sheet.  See Note 12 to the Consolidated Financial Statements included in this Form 10-Q.

(2) These obligations consist of cancelable and non-cancelable purchase commitments related to inventory, capital expenditures and other goods or services. In accordance with U.S. GAAP, these obligations are not recorded on our Consolidated Balance Sheets. See Note 13 to the Consolidated Financial Statements included in this Form 10-Q.

(3) We have become party to certain operating leases, for the leased space in Malvern, Pennsylvania, Gainesville, Georgia and Dublin, Ireland, as well as for office equipment, for which the minimum lease payments are presented.

(4) We are party to exclusive licenses with Orion for the development and commercialization of certain pipeline product candidates, under which we may be required to make certain milestone and royalty payments to Orion.  See Note 5 and Note 13(a) to the Consolidated Financial Statements included in the Form 10-Q. The amount reflects only payment obligations that are fixed and determinable. We are unable to reliably estimate the timing of these payments because they are dependent on the type and complexity of the clinical studies and intended uses of the products, which have not been established. In accordance with U.S. GAAP, these obligations are not recorded on our Consolidated Balance Sheets.

(5) We license the NMBs from Cornell University pursuant to a license agreement under which we are obligated to make annual license maintenance fee payments, milestone payments and patent cost payments and to pay royalties on net sales of the NMBs. The amount reflects only payment obligations that are fixed and determinable. We are unable to reliably estimate the timing of certain of these payments because they are dependent on the type and complexity of the clinical studies and intended uses of the products, which have not been established. In accordance with U.S. GAAP, certain of these obligations are not recorded on our Consolidated Balance Sheets. See Note 5 and 13(a) to the Consolidated Financial Statements included in this Form 10-Q.

(6) Pursuant to the purchase and sale agreement governing the Gainesville Transaction, we agreed to pay to Alkermes milestone and royalty payments. The amount reflects only payment obligations that are fixed and determinable. We are unable to reliably estimate the timing of these payments because they are in some instances, events that are not in our control and dependent on the commercial success of the product. In accordance with U.S. GAAP, the fair value of these obligations is recorded as contingent consideration on our Consolidated Balance Sheets. See Note 4 and Note 13(b) to the Consolidated Financial Statements included in this Form 10-Q.

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(7) We have entered into employment agreements with certain of our named executive officers. As of March 31, 2018, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than this amount, from that date through March 31, 2019. In accordance with U.S. GAAP, these obligations are not recorded on our Consolidated Balance Sheets. See Note 13 (f) to the Consolidated Financial Statements included in this Form 10-Q.  

(8) This value represents the deferred rent and non-current portion of payments due to Cornell University for past patent costs associated with the license agreement for the NMBs. In accordance with U.S. GAAP, these liabilities are recorded on our Consolidated Balance Sheets. See Note 5 and 13(a) to the Consolidated Financial Statements included in this Form 10-Q.

Off-Balance Sheet Arrangements

    We do not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.

Critical Accounting Policies and Estimates

Our critical accounting policies and estimates are disclosed in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form 10-K December 31, 2017 filed with the SEC on March 2, 2018. In the three months ended March 31, 2018, there were changes to the application of critical accounting policies previously disclosed in our most recent Annual Report on Form 10-K related to the adoption of ASU 2014-09 on January 1, 2018, as described below.

Revenue Recognition

Revenue Recognition

We generate revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. Our agreements with our commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components.  Our revenue policies listed below are reflective of ASU 2014-09,which the company adopted effective January 1, 2018.  See Note 18 to the Consolidated Financial Statements included in this Form 10-Q for additional information regarding our adoption of ASU 2014-09 and its impact on our financial statements.

Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration we expect to be entitled to as specified in the agreement with the commercial partner.

In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, we recognize revenue when the related sales occur by the commercial partner.  For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, we recognize revenue upon transfer of control of the manufactured product.  In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of our control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by our commercial partners.

Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, we evaluate whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which we have continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within our control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received.

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Item 3.Quantitative and Qualitative Disclosures About Market Risk

There has been no material change in our assessment of its sensitivity to market risk described in the “Quantitative and Qualitative Disclosures About Market Risk” section of our Annual Report on Form 10-K December 31, 2017 filed with the SEC on March 2, 2018.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) as of March 31, 2018. We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure.

A control system, no matter how well conceived and operated, can provide only reasonable, and not absolute, assurance that the objectives of the control system will be 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 the company have been detected. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. However, our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives. Based on the evaluation of our disclosure controls and procedures as of March 31, 2018, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings.

As part of the Gainesville Transaction, we acquired the rights to Zohydro ER®, which we license to our commercial partner Pernix Therapeutics, Inc., or Pernix, in the United States, and which is subject to ongoing intellectual property litigation and proceedings.

Zohydro ER® has been subject to four paragraph IV certifications with Actavis plc, or Actavis, regarding the filing of Abbreviated NDAs, or ANDAs, with the FDA for a generic version of Zohydro ER®, the filing of a supplemental ANDA, one of our issued patents relating to a formulation of Zohydro ER®. These certification notices alleged that the three U.S. patents listed in the FDA’s Orange Book for Zohydro ER® will not be infringed by Actavis’ proposed products, are invalid and/or are unenforceable. In 2014 and 2015, we, by ourselves and through Daravita Limited (a subsidiary of Alkermes and our predecessor in interest), filed two suits against Actavis in the U.S. District Court for the District of Delaware based on the ANDA and the sANDA, respectively. In February 2017, the District Court in the Actavis case ruled in our favor and enjoined Actavis from selling the proposed generic version of Zohydro ER®, which Actavis subsequently appealed to the U.S. Court of Appeals for the Federal Circuit. In October 2017, we filed suit against Actavis in the U.S. District Court for the District of Delaware based upon another issued patent relating to a formulation of Zohydro ER®. All litigation with Actavis settled in January 2018 via a multi-party settlement agreement among us, Pernix and Actavis, in which Actavis was granted a license to begin selling a generic version of Zohydro® ER on March 1, 2029, or earlier under certain circumstances.

Item 1A. Risk Factors.

There have been no material changes from our risk factors as previously reported in our Annual Report on Form 10-K for the year ended December 31, 2017.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Approval of the Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan

At our 2018 Annual Meeting of Shareholders held on May 4, 2018, or the Annual Meeting, our shareholders, upon the recommendation of our Board of Directors, approved the Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan, or the Plan. The Plan amends and restates the Recro Pharma, Inc. Amended and Restated Equity Incentive Plan to (i) increase the aggregate amount of shares of our common stock, par value $0.01 per share, or the Common Stock, available for issuance under the Plan to 7,036,737 shares, (ii) remove certain exceptions to annual individual grant limits, and (iii) adjust our ability to terminate or redeem options and stock appreciation rights in connection with a change of control, as defined in the Plan.

The Plan was previously approved, subject to shareholder approval, by our Board of Directors on March 22, 2018.  The Plan became effective immediately upon shareholder approval at the Annual Meeting.  A total of 7,036,737 shares of our Common Stock will be reserved for issuance under the Plan. In addition, pursuant to the Plan, on December 1 of each year, our Board of Directors may approve an increase to number of shares authorized for issuance under the Plan of up to five percent (5%) of the issued and outstanding Common Stock on such date.

A full description of the Plan is set forth in our definitive proxy statement filed with the Securities and Exchange Commission on March 23, 2018.  That description and the foregoing summary are qualified in their entirety by reference to the full text of the Plan, a copy of which is filed as Exhibit 10.2 hereto and incorporated herein by reference.

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Submission of Matters to a Vote of Security Holders

On May 4, 2018, we held our Annual Meeting. The following is a brief description of the final voting results for each of the proposals submitted to a vote of the shareholders at the Annual Meeting.

(a) Proposal 1 — Election of Class I Directors. Each of Winston J. Churchill and Wayne B. Weisman were elected to the Board of Directors as Class I directors to serve until our 2021 Annual Meeting of Shareholders and until their successors, if any, are elected or appointed, or their earlier death, resignation, retirement, disqualification or removal, as follows:

Name	Votes For		Votes Withheld		Broker Non-Votes
Winston J. Churchill		13,942,501		884,175		2,751,472
Wayne B. Weisman		14,727,778		98,898		2,751,472

(b) Proposal 2 — Ratification of Independent Registered Public Accountants. The appointment of KPMG LLP as our independent registered public accounting firm for the 2018 fiscal year was ratified, as follows:

Votes For		Votes Against		Abstentions		Broker Non-Votes
	17,441,075		124,258		12,815		—

(c) Proposal 3 — Approval of the Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan. The Plan was approved, as follows:

Votes For		Votes Against		Abstentions		Broker Non-Votes
	8,761,555		5,161,047		904,074		2,751,472

Item 6. Exhibits.

(a) The following exhibits are filed herewith or incorporated by reference herein:

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EXHIBIT INDEX

Exhibit No.	Description	Method of Filing
4.1	Registration Rights Agreement, dated March 2, 2018, by and between Recro Pharma, Inc. and Aspire Capital Fund, LLC.	Incorporated herein by reference to Exhibit 4.8 to the Company’s Annual Report on Form 10-K filed on March 2, 2018 (File No. 001-36329).
10.1	Common Stock Purchase Agreement, dated March 2, 2018, by and between Recro Pharma, Inc. and Aspire Capital Fund, LLC.	Incorporated herein by reference to Exhibit 10.38 to the Company’s Annual Report on Form 10-K filed on March 2, 2018 (File No. 001-36329).
10.2	Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan.	Filed herewith.
31.1	Rule 13a-14(a)/15d-14(a) certification of Principal Executive Officer.	Filed herewith.
31.2	Rule 13a-14(a)/15d-14(a) certification of Principal Financial and Accounting Officer.	Filed herewith.
32.1	Section 1350 certification, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	Filed herewith.
101 INS	XBRL Instance Document	Filed herewith.
101 SCH	XBRL Taxonomy Extension Schema	Filed herewith.
101 CAL	XBRL Taxonomy Extension Calculation Linkbase	Filed herewith.
101 DEF	XBRL Taxonomy Extension Definition Linkbase	Filed herewith.
101 LAB	XBRL Taxonomy Extension Label Linkbase	Filed herewith.
101 PRE	XBRL Taxonomy Extension Presentation Linkbase Document	Filed herewith.

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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.

	RECRO PHARMA, INC.
Date: May 9, 2018	By:	/s/ Gerri A. Henwood
		Gerri A. Henwood
		President and Chief Executive Officer
		(Principal Executive Officer)
Date: May 9, 2018	By:	/s/ Ryan D. Lake
		Ryan D. Lake
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

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EX-10.2

Exhibit 10.2

RECRO PHARMA, INC.

2018 AMENDED AND RESTATED EQUITY INCENTIVE PLAN

1. Purpose. The Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan¹ is intended as an additional incentive to current and prospective employees, consultants and directors of the Company to enter into or remain in the service or employ of the Company or any Affiliate and to devote themselves to the Company’s success, and to encourage the creation of shareholder value. Under the Plan, the Company may provide such persons with opportunities to acquire or increase their interests in the Company through options to purchase the Company’s Common Stock, grants of stock appreciation rights and awards of the Company’s Common Stock. Under the Plan, the Company may grant (i) ISOs, (ii) Nonqualified Options, (iii) Stock Appreciation Rights, (iv) Stock Awards, (v) Restricted Stock Awards and (vi) Restricted Stock Units.

2. Term of Plan. The Plan was originally adopted by the Board of Directors on October 8, 2013, and is amended and restated as of March 22, 2018.

3. Definitions. Capitalized terms not otherwise defined in the Plan shall have the following meanings:

“Affiliate” means a corporation which is a parent corporation or a subsidiary corporation with respect to the Company within the meaning of section 424(e) or (f) of the Code.

“Award” means any Option, SAR, Restricted Stock or Restricted Stock Unit granted pursuant to the terms of this Plan.

“Board” means the Board of Directors of the Company.

“Cause” for termination of employment or service shall have the meaning ascribed thereto in the Recipient’s employment or service agreement or, in the absence of such a definition, shall mean:

(i) Conviction of, or agreement to a plea of nolo contendere to, a felony, or any crime or offense lesser than a felony involving the property of the Company or an Affiliate;

(ii) Conduct that has caused demonstrable and serious injury to the Company or an Affiliate, monetary or otherwise;

(iii) Willful refusal to perform or substantial disregard of duties properly assigned, as determined by the Board;

(iv) Breach of duty of loyalty to the Company or an Affiliate or other act of fraud or dishonesty with respect to the Company or an Affiliate; or

(v) Violation of the Company’s code of conduct.

The definition of Cause set forth in the Recipient’s employment or service agreement with the Company or any of its Affiliates shall control if such definition is different from the definition of Cause set forth herein.

“Code” means the Internal Revenue Code of 1986, as amended from time to time, or any successor statute or statutes thereto. Reference to any particular section of the Code shall include any successor section.

“Common Stock” means the Common Stock, par value $0.01, of the Company.

“Company” means Recro Pharma, Inc., a Pennsylvania corporation.

“Covered Employee” means a Recipient who is a Covered Employee as defined in Section 162(m) of the Code for the tax year of the Company with regard to which a deduction in respect of such person’s Award would be allowed.

¹ The Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan amends and restates the 2013 Equity Incentive Plan that was originally adopted by the Board of Directors on October 8, 2013, as amended and restated by the Amended and Restated Equity Incentive Plan as of April 1, 2015.

“Disability” means, as determined by the Board, (a) the inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or that has lasted or can be expected to last for a continuous period of not less than 12 months or (b) Recipient’s becoming disabled within the meaning of section 22(e)(3) of the Code.

“Exchange Act” means the Securities Exchange Act of 1934, as amended.

“Fair Market Value” of a share of Common Stock on any day means the officially-quoted closing selling price of the stock on the principal securities exchange on which the Common Stock is then listed for trading (including for this purpose the NASDAQ Capital Market) for the applicable trading day.

“Grant Date” means the effective date on which an Option is granted to an Optionee under the Plan.

“ISO” means an Option granted under the Plan that is intended to qualify as an incentive stock option within the meaning of section 422(b) of the Code.

“Nonqualified Option” means an Option granted under the Plan that is not intended to qualify as an ISO.

“Option” means an option to purchase Common Stock granted under the Plan, which may be designated as either an ISO or a Nonqualified Option.

“Option Documents” means written documents in such form as approved from time to time by the Board, which shall be given to Optionees and shall set forth the terms and conditions of Options granted to Optionees under the Plan.

“Optionee” means an employee, consultant or director to whom an Option is granted under the Plan.

“Option Price” means the price at which Option Shares may be purchased under the terms of an Option.

“Option Shares” means the shares of Common Stock that may be purchased by an Optionee upon exercise of an Option.

“Performance Goals” means goals and objectives established by the Board, in its sole discretion, as contingencies for Awards to vest and/or become exercisable or distributable based on such criteria and objectives as the Board may select from time to time, subject to the limitations of Section 162(m) of the Code, including, without limitation, the performance of the Recipient, the Company, one or more of its Affiliates or divisions or any combination of the foregoing.

“Plan” means the Recro Pharma, Inc. 2018 Amended and Restated Equity Incentive Plan.

“Recipient” means an employee, consultant or director to whom an Option, Stock Award, Stock Appreciation Right, Restricted Stock or Restricted Stock Unit is granted under the Plan.

“Restricted Stock Award” means a grant of shares under this Plan that is subject to the restrictions under Section 8.

“Restricted Stock Unit” means a contractual right underlying an Award granted under Section 8 that is denominated in shares, which unit represents a right to receive a share (or the value of a share) upon the terms and conditions set forth in the Plan and the applicable Agreement.

“Retirement” means the date that the Recipient reaches age seventy (70).

“SAR Shares” means the shares of Common Stock that may be issued in connection with the Company’s payment upon the exercise of a Stock Appreciation Right.

“Separation from Service” means, with respect to a Recipient who is an employee of the Company or an Affiliate, the termination of employment with the Company and all Affiliates that constitutes a “separation from service” within the meaning of Treas. Reg. § 1.409A-1(h)(1), (ii) with respect to a Recipient who is a consultant of the Company or an Affiliate, the expiration of his contract

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or contracts under which services are performed that constitutes a “separation from service” within the meaning of Treas. Reg. § 1.409A-1(h)(2), or (iii) with respect to a Recipient who is a non-employee director of the Company or an Affiliate, the date on which such non-employee director ceases to be a member of the Board (or other applicable board of directors) for any reason.

“Stock Appreciation Right” means a Recipient’s right to receive from the Company, in SAR Shares, cash or a combination thereof, an amount in excess, if any, of (i) if the Stock Appreciation Right is granted in connection with an Option, the Fair Market Value of such Option Shares on the date of surrender of such Option Shares over the Option Price of such surrendered Option Shares, or (ii) if the Stock Appreciation Right is granted on a stand-alone basis, the Fair Market Value of the Common Stock on the date of exercise over the initial basis of the Stock Appreciation Right as determined under the Stock Appreciation Right Agreement provided the initial basis shall be at least the Fair Market Value of the Common Stock on the date of grant.

“Stock Appreciation Right Agreement” means the agreement between the Company and Recipient pursuant to which a Stock Appreciation Right is granted.

“Stock Award” means the award of Common Stock granted to a Recipient under the Plan.

“Stock Award Shares” means shares of Common Stock which are issued pursuant to a Stock Award under the Plan.

4. Administration. The Plan shall be administered by a committee of Board members, which may consist of “outside directors” as defined under section 162(m) of the Code, and related Treasury regulations, and “non-employee directors” as defined under Rule 16b-3 under the Exchange Act. However, the Board may ratify or approve any grants as it deems appropriate, and the Board shall approve and administer all grants made to non-employee directors. To the extent that a committee or subcommittee administers the Plan, references in the Plan to the “Board” shall be deemed to refer to the committee or subcommittee.

The Board shall from time to time at its discretion grant Awards pursuant to the terms of the Plan. The Board shall have plenary authority to determine the Recipients to whom and the times at which Awards shall be granted, and the form and substance of Awards made under the Plan to each Recipient, and the conditions and restrictions, if any, subject to which such Awards will be made (which need not be identical for all Recipients) thereof, subject, however, to the express provisions of the Plan. In making such determinations the Board may take into account the nature of the Recipient’s services and responsibilities, the Recipient’s present and potential contribution to the Company’s success and such other factors as it may deem relevant. The interpretation and construction by the Board of any provision of the Plan or of any Award granted under it shall be final, binding and conclusive. Notwithstanding the foregoing, the Board shall not take any of the following actions without shareholder approval, except as provided in Section 12: (i) reduce the exercise price following the grant of an Option or SAR; (ii) exchange an Option or SAR which has an exercise price that is greater than the Fair Market Value of a Share for cash or Shares; or (iii) cancel an Option or SAR in exchange for a replacement option or another Award with a lower exercise price.

No member of the Board shall be personally liable for any action or determination made in good faith with respect to the Plan or any Award granted under it. No member of the Board shall be liable for any act or omission of any other member of the Board or for any act or omission on his own part, including but not limited to the exercise of any power and discretion given to him under the Plan, except those resulting from (i) any breach of such member’s duty of loyalty to the Company or its shareholders, (ii) acts or omissions not in good faith or involving intentional misconduct or a knowing violation of law, and (iii) any transaction from which the member derived an improper personal benefit.

In addition to such other rights of indemnification as he may have as a member of the Board, and with respect to the administration of the Plan and the granting of Awards under it, each member of the Board shall be entitled without further action on his part to indemnification from the Company for all expenses (including the amount of any judgment and the amount of any approved settlement made with a view to the curtailment of costs of litigation, other than amounts paid to the Company itself) reasonably incurred by him in connection with or arising out of any action, suit or proceeding with respect to the administration of the Plan or the granting of Awards under it in which he may be involved by reason of his being or having been a member of the Board, whether or not he continues to be

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such member of the Board at the time of the incurring of such expenses; provided, however, that such indemnification shall not include any expenses incurred by such member of the Board: (i) in respect of matters as to which he shall be finally adjudged in such action, suit or proceeding to have been guilty of gross negligence or willful misconduct in the performance of his duties as a member of the Board; or (ii) in respect of any matter in which any settlement is effected in an amount in excess of the amount approved by the Company on the advice of its legal counsel; and provided further that no right of indemnification under the provisions set forth herein shall be available to or accessible by any such member of the Board unless within five days after institution of any such action, suit or proceeding he shall have offered the Company in writing the opportunity to handle and defend such action, suit or proceeding at its own expense. The foregoing right of indemnification shall inure to the benefit of the heirs, executors or administrators of each such member of the Board and shall be in addition to all other rights to which such member of the Board would be entitled to as a matter of law, contract or otherwise.

5. Eligibility. All employees of the Company or its subsidiary Affiliates (who may also be officers or directors of the Company or its Affiliates) shall be eligible to receive Stock Awards, Stock Appreciation Rights, Restricted Stock Awards or Restricted Stock Units and Options hereunder, and such Options may be either ISOs or Nonqualified Options. All non-employee directors of the Company and all consultants or advisory board members providing services to the Company shall be eligible to receive Nonqualified Options, Stock Appreciation Rights, Stock Awards, Restricted Stock Awards and Restricted Stock Units hereunder. All employees of the Company’s parent Affiliates (who may also be officers of the parent Affiliate) shall be eligible to receive grants of Stock Awards.) The Board, in its sole discretion, shall determine whether an individual qualifies as an employee, consultant or Recipient. A Recipient may receive more than one Award of Options, Stock Appreciation Rights, Stock Awards, Restricted Stock or Restricted Stock Units. No member of the Board shall vote as a member of the Board with respect to the grant of any Award to himself or herself, except in the case when grants are being made to all similarly situated Board members on the same terms and conditions. In cases in which abstention is required by the foregoing sentence, the affirmative vote of a majority of the remaining members of the Board (or of the sole remaining member of the Board) shall constitute the action of the Board.

6. Shares Available for Awards. Except as provided in Section 12, the aggregate maximum number of shares of Common Stock (the “Shares”) that may be issued pursuant to the Plan is Seven Million Thirty-Six Thousand Seven Hundred Thirty-Seven (7,036,737), inclusive of Shares subject to Awards issued under prior versions of the Plan that remain outstanding as of the effective date of the Plan (the “Reserved Shares”). On the 1^st of December of each year, the number of Reserved Shares may be increased by the Board, without the necessity of further approval from the Shareholders, by an amount not greater than five percent (5%) of the Company’s issued and outstanding capital stock, or such lower amount as determined by the Board in its sole discretion. Such Shares may be in whole or in part authorized and unissued or held by the Company as treasury shares. If any grant under the Plan expires, lapses, terminates unexercised, becomes unexercisable or is forfeited as to any Shares, or is tendered or withheld as to any Shares in payment of the exercise price of the grant or the taxes payable with respect to the exercise, then such unpurchased, forfeited, tendered or withheld Shares shall thereafter be available for further grants under the Plan unless, in the case of Options granted under the Plan, related SARs are exercised.

With respect to SARs that are settled in Common Stock, upon settlement, only the number of shares of Common Stock delivered to a Recipient upon the exercise of the SARs shall count against the number of Shares issued under the Plan. Any Award under the Plan settled in cash shall not be counted against the foregoing maximum share limitations.

Shares issued under Awards granted in assumption, substitution or exchange for previously granted awards of a company acquired by the Company (“Substitute Awards”) shall not reduce Shares available under Plan. Available shares under a shareholder approved plan of an acquired company (as appropriately adjusted to reflect such acquisition) may be used for Awards under this Plan and shall not reduce the number of Shares available under this Plan, except as required by the rules of any applicable stock exchange.

To the extent required by Section 162(m) of the Code for Awards under the Plan to qualify as “performance-based compensation,” the following individual Recipient limitations shall apply: the maximum number of shares of Common Stock subject to any Award for which the grant of such Award is subject to the attainment of Performance Goals in accordance with Section 8, which may be granted under this Plan during any fiscal year of the Company to each Recipient shall be 400,000 shares per type of Award (which shall be subject to

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increase or decrease pursuant to Section 12), provided that the maximum number of shares of Common Stock for all types of Awards does not exceed 1,000,000 (which shall be subject to increase or decrease pursuant to Section 12) during any fiscal year of the Company.

7. Option Shares, SAR Shares and Stock Award Shares. Options granted pursuant to the Plan shall be evidenced by Option Documents in such form as the Board shall from time to time approve, which Option Documents shall specify whether the Option is intended to be an ISO or a Nonqualified Option for federal income tax purposes. An Option shall only be an ISO to the extent it does not exceed the limitation set forth in subsection 7(c) below, is described as an ISO in the Option Document, and is granted to a person who is an employee of the Company or an Affiliate on the Grant Date. All Option Documents shall comply with and be subject to the following terms and conditions and with any other terms and conditions (including vesting schedules for the exercisability of Options) the Board shall from time to time provide that are not inconsistent with the terms of the Plan.

(a) Option Price. Each Option Document shall state the “Option Price” at which Option Shares may be purchased, which in no event shall be less than the Fair Market Value of the Common Stock on the Grant Date, provided, however, that if an ISO is granted to an Optionee who then owns, directly or by attribution under section 424(b) of the Code, shares possessing more than ten percent of the total combined voting power of all classes of stock of the Company or an Affiliate, then the Option Price shall be at least 110% of the Fair Market Value of the Option Shares on the Grant Date.

(b) Medium of Payment. An Option shall be exercised by written notice to the Company upon such terms and conditions as the Option Document may provide and in accordance with such other procedures for the exercise of Options as the Board may establish from time to time. The method or methods of payment of the Option Price to be paid upon exercise of an Option shall be determined by the Board and set forth in the Option Document, and may consist of (i) cash, (ii) certified check payable to the order of the Company, (iii) payment through a broker in accordance with procedures permitted by Regulation T of the Federal Reserve Board, (iv) shares of Common Stock previously acquired by the Optionee, as permitted in the discretion of the Board, (v) reduction in the number of shares of Common Stock otherwise deliverable upon exercise of the Option with a Fair Market Value equal to the aggregate Option Price at the time of exercise (a so-called “cashless exercise”), or (vi) such other mode of payment as permitted for the issuance of shares under the Pennsylvania Business Corporation Law, as amended, and approved by the Board, or any combination of the foregoing methods of payment. Payment of the Option Price by a method other than cash shall be subject to such restrictions and limitations as set forth in the Option Document.

(c) Number of Option Shares. Each Option Document shall state the number of Option Shares to which it pertains. In no event shall the aggregate Fair Market Value of the Option Shares (determined on the Grant Date) with respect to which an ISO is exercisable for the first time by the Optionee during any calendar year (under all incentive equity plans of the Company or its Affiliates) exceed $100,000.

(d) Issuance of Option Shares. Subject to the provisions of this Section 7, the Company shall effect the issuance of Option Shares purchased under an Option as soon as practicable after the exercise thereof, payment of the Option Price thereof and compliance with any requirements for the withholding of income taxes. No Recipient or other person exercising an Option shall have any of the rights of a shareholder of the Company with respect to Option Shares purchased as a result of such exercise until due exercise and full payment has been made and the requirements of Section 7 have been satisfied. No adjustment shall be made for cash dividends or other rights for which the record date is prior to the date of such due exercise and full payment. No Option shall be deemed to have been exercised prior to the receipt by the Company of written notice of such exercise and of payment in full of the Option Price for the Option Shares to be purchased. Each such notice shall specify the number of Option Shares to be purchased.

(e) Termination of Options. No Option shall be exercisable after the first to occur of the following:

(i) Expiration of the Option term specified in the Option Document, which shall not exceed ten years from the date of grant (or, in the case of an ISO, five years from the date of grant if, on such date the Optionee owns, directly or by attribution under section 424(b) of the Code, shares possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Company or an Affiliate).

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(ii) Expiration of one year from the date the Optionee’s employment with the Company or its Affiliates terminates by reason of the Optionee’s Disability or death.

(iii) Expiration of three months (or such shorter period as the Board may select) from the date the Optionee’s employment with the Company or its Affiliates terminates, unless such termination was due to Disability, death or termination for Cause.

(iv) Immediately upon the date the Optionee’s employment or service with the Company or its Affiliates terminates, if the Board finds, after full consideration of the facts presented on behalf of both the Company and the Optionee, that the Optionee has been discharged from employment or service with the Company or an Affiliate for Cause. In the event of a finding that the Optionee has been discharged for Cause, in addition to immediate termination of the Option, the Optionee shall automatically forfeit all Option Shares for which the Company has not yet delivered the share certificates upon refund of the Option Price.

(v) The date, if any, set by the Board under terms specified in an Option Document to be an accelerated expiration date in the event of a “Change in Control” (as defined in Section 9 below), provided an Optionee who holds an Option is given advance written notice.

(f) Extension of Time to Exercise. The Board may, if it determines that to do so would be in the Company’s best interests, provide in a specific case or cases to extend the period of time that a Nonqualified Option may be exercised by Optionee whose employment with the Company and its Affiliates has terminated, provided that the time to exercise an Option shall in no event be extended beyond the original term of the Option as set forth in subsection 7(e)(i).

(g) Sale or Reorganization. If the Company is merged or consolidated with another corporation, or if the property or stock of the Company is acquired by another corporation, and if the Options are not accelerated as provided in subsection 7(e) above, the Board shall be authorized to substitute the Options issued under the Plan with options to acquire stock of the merged, consolidated or acquiring corporation, which substitution of options shall comply with the requirements of sections 424(a) and 409A of the Code.

(h) Transfers. No ISO granted under the Plan may be transferred, except by will or by the laws of descent and distribution. During the lifetime of the Optionee, such ISO may be exercised only by him.

(i) Other Provisions. The Option Documents shall contain such other provisions including, without limitation, additional restrictions upon the exercise of the Option or additional limitations upon the term of the Option, as the Board shall deem advisable.

(j) Amendment. Subject to the provisions of the Plan, the Board shall have the right to amend Option Documents issued to Optionee, subject to the Optionee’s consent if such amendment is adverse to the Optionee, except that the consent of the Optionee shall not be required for any amendment made under Section 12.

8. Restricted Stock and Restricted Stock Units. The Awards granted under this Section 8 are subject to such restrictions as the Board may impose (including, without limitation, any limitation on the right to vote shares underlying Restricted Stock Units or the right to receive any dividend, other right or property), which restrictions may lapse separately or in combination at such time or times, in such installments or otherwise, as the Board may deem appropriate. Such Awards will be evidenced by an agreement containing the terms of the Awards, including, but not limited to: (i) the number of shares of Restricted Stock or Restricted Stock Units subject to such Award; (ii) the purchase price, if any, of the shares of Restricted Stock or Restricted Stock Units and the means of payment for the shares of Restricted Stock or Restricted Stock Units; (iii) the Performance Goals, if any, and level of achievement in relation to the Performance Goals that shall determine the number of shares of Restricted Stock or Restricted Stock Units granted, issued, retainable and/or vested; provided, however, that any such Performance Goals shall comply with Section 162(m) of the Code; (iv) such terms and conditions of the grant, issuance, vesting and/or forfeiture of the Restricted Stock or Restricted Stock Units as may be determined from time to time by the Board; (v) restrictions on transferability of the Restricted Stock or Restricted Stock Units; and (vi) such further terms and conditions, in each case, not inconsistent with this Plan as may be determined from time to time by the

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Board. Such Performance Goals may incorporate, if and only to the extent permitted under Section 162(m) of the Code, provisions for disregarding (or adjusting for) changes in accounting methods, corporate transactions (including, without limitation, dispositions and acquisitions) and other similar type events or circumstances. To the extent any such provision would create impermissible discretion under Section 162(m) of the Code or otherwise violate Section 162(m) of the Code, such provision shall be of no force or effect.

(a) Without limiting the foregoing, and except as otherwise revised in the Award agreement documenting a service-based Restricted Stock Unit Award (“RSUs”), the following general rules will apply to outstanding RSUs at the time of Separation from Service:

(i) In the event of Separation from Service for Cause, all outstanding RSUs will immediately terminate and be forfeited.

(ii) In the event of Separation from Service due to death or Retirement of the Recipient while employed by the Company or any of its Affiliates, or the termination of service of the Recipient due to Disability (whether or not a Separation from Service), then an amount of unvested RSUs shall vest equal to a percentage, the numerator of which equals the number of days that has elapsed as of the date of death or Retirement or the date on which such Disability commenced (such date to be determined by the Board in its sole discretion) in the vesting restriction period for each applicable vesting tranche, and the denominator of which equals the total number of days in each such vesting restriction period, rounded down to the nearest whole Share. All vested RSUs will be paid in accordance with the payment provisions set forth in this Plan.

(iii) In all other events of Separation from Service, to the extent not previously paid, the Recipient shall be paid any vested RSUs in accordance with the payment provisions of Section 8(c), and all unvested RSUs shall immediately terminate and be forfeited.

(b) Any Award of Restricted Stock or Restricted Stock Units may be evidenced in such manner as the Board may deem appropriate, including, without limitation, book-entry registration or issuance of a stock certificate or certificates. In the event any stock certificate is issued in respect of shares underlying a Restricted Stock Award, such certificate will be registered in the name of the Recipient and bear an appropriate legend referring to the terms, conditions, and restrictions applicable to such shares.

(c) Restricted Stock and Restricted Stock Unit Awards shall (subject to satisfaction of any purchase price requirement) be transferred or paid to the Recipient as soon as practicable following the Award date or the termination of the vesting or other restrictions set forth in the Plan or the Award and the satisfaction of any and all other conditions of the Award applicable to such Restricted Stock or Restricted Stock Unit Award (the “Restriction End Date”), but in no event later than two and one-half (2 ¹⁄₂) months following the end of the calendar year that includes the later of the Award date or the Restriction End Date, as the case may be. In the event a Recipient terminates service with the Company due to a Disability, then the Recipient’s vested Restricted Stock Units shall be paid to the Recipient within thirty (30) days of the Board’s determination of Disability. Notwithstanding any of the foregoing, to the extent that the provisions of any Award for Restricted Stock Units require, distributions of stock under circumstances that constitute a “deferral of compensation” shall conform to the applicable requirements of Section 409A of the Code, including, without limitation, the requirement that a distribution to a Recipient who is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) which is made on account of the specified employee’s Separation from Service shall not be made before the date which is six (6) months after the date of Separation from Service.

9. Change of Control. Unless otherwise provided in a Recipient’s employment or service agreement, in the event of a Change in Control (as defined below), the Board may take whatever action with respect to Awards it deems necessary or desirable, including, without limitation, accelerating the vesting of an Award, terminating an Award or redeeming an Award. If Options or Stock Appreciation Rights granted pursuant to the Plan are accelerated, such Options and Stock Appreciation Rights shall become immediately exercisable in full.

(a) Unless otherwise defined in a Recipient’s employment agreement, a “Change of Control” shall be deemed to have occurred upon the happening of any of the following events:

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(i) Any “person” (as that term is used in Sections 13 and 14(d)(2) of the Exchange Act or any successors thereto) becomes the “beneficial owner” (as that term is used in Section 13(d) of the Exchange Act or any successor thereto), directly or indirectly, of 50% or more of the Company’s capital stock entitled to vote in the election of directors, excluding any “person” who becomes a “beneficial owner” in connection with a Business Combination (as defined in paragraph (iii) below) which does not constitute a Change in Control under said paragraph (iii);

(ii) Persons who on the effective date of the plan of reorganization of the Company (the “Commencement Date”) constitute the Board (the “Incumbent Directors”) cease for any reason, including without limitation, as a result of a tender offer, proxy contest, merger or similar transaction, to constitute at least a majority thereof; provided that, any person becoming a director of the Company subsequent to the Commencement Date shall be considered an Incumbent Director if such person’s election or nomination for election was approved by a vote of at least two-thirds (2/3) of the Incumbent Directors; but provided further that, any such person whose initial assumption of office is in connection with an actual or threatened election contest relating to the election of members of the Board or other actual or threatened solicitation of proxies or consents by or on behalf of a “person” (as defined in Sections 13(d) and 14(d) of the Exchange Act) other than the Board, including by reason of agreement intended to avoid or settle any such actual or threatened contest or solicitation, shall not be considered an Incumbent Director;

(iii) Consummation of a reorganization, merger or consolidation or sale or other disposition of all or substantially all of the assets of the Company (a “Business Combination”), in each case, unless, following such Business Combination, all or substantially all of the individuals and entities who were the beneficial owners of outstanding voting securities of the Company immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the company resulting from such Business Combination (including, without limitation, a company which, as a result of such transaction, owns the Company or all or substantially all of the Company’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination, of the outstanding voting securities of the Company; or

(iv) the liquidation or dissolution of the Company.

In addition, with respect to any Award that is characterized as “nonqualified deferred compensation” within the meaning of Section 409A of the Code, an event shall not be considered to be a Change in Control under the Plan for purposes of payment of such Award unless such event is also a “change in ownership,” a “change in effective control” or a change in ownership of a substantial portion of the assets” of the Company within the meaning of Section 409A of the Code.

10. Grant of Stock Appreciation Rights.

(a) General. The Board shall have authority to grant Stock Appreciation Rights under the Plan. Subject to the satisfaction in full of any conditions, restrictions or limitations imposed in accordance with the Plan or any Stock Appreciation Right Agreement, a Stock Appreciation Right shall entitle the Recipient to surrender to the Company the Stock Appreciation Right in exchange for SAR Shares, cash or a combination thereof as herein provided, in the amount described in Section 10(c)(ii) hereof.

(b) Grant. Stock Appreciation Rights may be granted in conjunction with all or part of any Option granted under the Plan (“Tandem SARs”), in which case the exercise of the Stock Appreciation Right shall require the cancellation of a corresponding portion of the Option, and the exercise of an Option shall result in the cancellation of a corresponding portion of the Stock Appreciation Right. In the case of an Nonqualified Stock Option, Tandem SARs may be granted either at or after the time of grant of such Option and provided the SAR satisfies conditions under Treas. Reg. § 1.422-5(d)(3). In the case of an ISO, Tandem SARs may be granted only at the time of grant of such Option. A Stock Appreciation Right may also be granted on a stand-alone basis. The grant of a Stock Appreciation Right shall occur as of the date the Board determines. Each Stock Appreciation Right granted under this Plan shall be evidenced by a Stock Appreciation Right Agreement, which shall embody the terms

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and conditions of such Stock Appreciation Right and which shall be subject to the terms and conditions set forth in this Plan.

(c) Terms and Conditions. Stock Appreciation Rights shall be subject to such terms and conditions as shall be determined by the Board, including the following:

(i) Period and Exercise. The term of a Stock Appreciation Right shall be established by the Board. If granted in conjunction with an Option, such Tandem SAR shall have a term which is the same as the term for the Option and shall be exercisable only at such time or times and to the extent the related Options would be exercisable in accordance with the provisions of Section 7 of the Plan. A Stock Appreciation Right which is granted on a stand-alone basis shall be for such period and shall be exercisable at such times and to the extent provided in the Stock Appreciation Right Agreement. Stock Appreciation Rights shall be exercised by the Recipient’s giving written notice of exercise in form satisfactory to the Company specifying the portion of the Stock Appreciation Right to be exercised.

(ii) Amount. Upon the exercise of a Tandem SAR, a Recipient shall be entitled to receive an amount in cash, SAR Shares or both as determined by the Board or as otherwise permitted in the Stock Appreciation Right Agreement, equal in value to the excess of the Fair Market Value per share of an Option Share at the exercise date over the Option Price of such Option Shares multiplied by the number of Option Shares in respect of which the Stock Appreciation Right is exercised. In the case of a Stock Appreciation Right granted on a stand-alone basis, the Recipient shall be entitled to receive an amount in cash, SAR Shares or both as determined by the Board or as otherwise permitted in the Stock Appreciation Right Agreement, equal to the value in excess of the Fair Market Value of the Common Stock on the date of exercise of the Stock Appreciation Right over the initial basis of the Stock Appreciation Right as set forth in the Stock Appreciation Agreement which shall be at least the Fair Market Value of the Common Stock on the date of grant.

(iii) Non-transferability of Stock Appreciation Rights. Tandem SARs shall be transferable only when and to the extent that the related Option would be transferable under the Plan unless otherwise provided in an Agreement. No other Stock Appreciation Rights granted hereunder may be other than by will, the laws of descent and distribution, or pursuant to a qualified domestic relations order.

(iv) Termination. Tandem SARs shall terminate at such time as the related Option would terminate under the Plan, unless otherwise provided in an Agreement as to a Nonqualified Option. All other Stock Appreciation Rights shall terminate as provided in the Stock Appreciation Right Agreement. No Stock Appreciation Right shall terminate more than ten years from the Grant Date.

(v) Incentive Stock Option. A Stock Appreciation Right granted in tandem with an ISO shall not be exercisable unless the Fair Market Value of the Common Stock on the date of exercise exceeds the Option Price. In no event shall any amount paid pursuant to the Stock Appreciation Right exceed the difference between the Fair Market Value on the date of exercise and the Option Price.

11. Grant of Stock Awards. Stock Awards will consist of shares of Common Stock transferred to Recipients, without payment or other consideration therefor. Stock Awards shall be subject to such terms and conditions as the Board determines appropriate, including without limitation, restrictions on sale or other disposition of such Stock Award Shares, and the rights of the Company to reacquire such Stock Award Shares upon termination of Recipients employment with the Company within specified periods, whether for Cause or otherwise.

12. Adjustments on Changes in Common Stock. In the event that any reorganization, recapitalization, stock split, reverse stock split, stock dividend, combination of shares, merger, consolidation, distribution of assets, or any other change in the corporate structure or shares of the Company affects Shares such that an adjustment is appropriate in order to prevent dilution or enlargement of the rights of Recipients under the Plan, the Board shall make such equitable adjustments in any or all of the following in order to prevent such dilution or enlargement of rights: the number and kind of Shares or other property available for issuance under the Plan (including, without limitation, the total number of Shares available for issuance under the Plan pursuant to Section 6), the number and kind of Awards or other property covered by Awards previously made under the Plan, and the exercise price of outstanding Options and SARs. Any such adjustment shall be final, conclusive and binding for all purposes of the

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Plan provided that no adjustment shall be made which will cause an ISO to lose its status as such or will cause any Option or Stock Appreciation Right to lose its status as exempt from Code Section 409A. Any adjustments made under this Section 12 shall be made in a manner which does not adversely affect the exemption provided pursuant to Rule 16b-3 under the Exchange Act. In the event of any merger, consolidation or other reorganization in which the Company is not the surviving or continuing corporation or in which a Change in Control is to occur, all of the Company’s obligations regarding any Awards that were granted hereunder and that are outstanding on the date of such event shall, on such terms as may be approved by the Committee prior to such event, be assumed by the surviving or continuing corporation or canceled in exchange for property (including cash).

13. Amendment and Termination of the Plan. The Board may terminate the Plan at any time, or amend the Plan from time to time in such manner as it may deem advisable. Notwithstanding the foregoing, any amendment which would change the class of individuals eligible to receive an Award, extend the expiration date of the Plan, or increase the maximum aggregate number of shares of Common Stock available for issuance under the Plan will only be effective if such action is approved by a majority of the outstanding voting stock of the Company within twelve months before or after such action.

14. Continued Employment. The grant of an Award pursuant to the Plan shall not be construed to imply or to constitute evidence of any agreement, express or implied, on the part of the Company or any Affiliate to retain the Recipient in the employ of the Company or an Affiliate, as a member of the Board, as an independent contractor or in any other capacity, whichever the case may be.

15. Withholding of Taxes. Whenever the Company proposes or is required to issue or transfer an Award, the Company shall have the right to (a) require the recipient or transferee to remit to the Company an amount sufficient to satisfy any federal, state and/or local withholding tax requirements prior to the delivery or transfer of any certificate or certificates for such Award or (b) take whatever action it deems necessary to protect its interests, including the right to deduct the amount required to be withheld from any payment of any kind otherwise due to the Recipient. If and to the extent permitted by the Board, a Recipient may satisfy applicable withholding requirements by the delivery to the Company of previously held shares of Common Stock or the withholding of Awards otherwise issuable to the Recipient.

16. General.

(a) Effective Date.  The Plan will become effective upon its approval by the Company’s stockholders. It will continue in effect for a term of ten (10) years from the date of the initial Board action to adopt the Plan unless terminated earlier. 

(b) Other Plans. The adoption of the Plan shall not be construed as creating any limitations on the power of the Board to adopt such other incentive arrangements as it may deem desirable, including without limitation the awarding of equity incentives otherwise than under the Plan. Unless otherwise provided by the Board in a written agreement between the Recipient and the Company or an Affiliate, except as may otherwise be provided for under a pension or welfare benefit plan subject to ERISA, the amounts deemed paid to a Recipient under the Plan shall not be taken into account, in any manner, as salary, compensation or bonus in determining the amount of any payment under any pension, retirement, or other employee benefit plan, program or policy of the Company or any Affiliate.

(d) Governing Law. The validity, construction, interpretation and effect of the Plan and Award agreements issued pursuant to the Plan shall be governed and construed by and determined in accordance with the laws of the Commonwealth of Pennsylvania, without giving effect to the conflict of laws provisions thereof.

17. Compliance with 409A and ISO Requirements.

(a) Exemption from and Compliance with 409A. The Board shall administer, construe, and interpret the Plan, and exercise its authority and discretion, so that all Options, Stock Appreciation Rights, Stock Awards, Restricted Stock or Restricted Stock Units granted under the Plan satisfy the requirements for an exemption from or comply with Code Section 409A and that Options intended to be ISOs are eligible for that tax treatment. Notwithstanding any provision of this Plan to the contrary, all rights under this Plan shall be designed and

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administered to be exempt from Section 409A of the Code. To the extent that the Board or any governmental agency determines that any rights hereunder are subject to Section 409A of the Code, this Plan shall incorporate (or shall be amended to incorporate) the terms and conditions necessary to avoid the consequences specified in Section 409A(a)(1) of the Code.

(b) Contemplated Amendments. It is expressly contemplated that the Board may amend the Plan, any Option Document, any Stock Appreciation Right Agreement, or terms of any Stock Award or Restricted Stock Unit in any respect the Board deems necessary or advisable to provide the Recipient with the maximum benefits provided or to be provided under the provisions of the Code and the regulations promulgated thereunder relating to ISOs or to avoid additional income taxes and other consequences arising from nonqualified deferred compensation that is not exempt from or that does not comply with Code Section 409A and/or to bring the Plan and/or the Option, Stock Appreciation Right, Stock Award or Restricted Stock Unit granted under it into compliance with or qualification for exemption from Code Section 409A or, as to ISOs, eligibility for ISO tax treatment.

(c) No Obligation. Notwithstanding any other provision of the Plan, any Option Document, any Stock Appreciation Right Agreement, or terms of any Stock Award or Restricted Stock Unit the Company, any Affiliate, the Board, or any of their employees or agents, (i) shall have no obligation to take any action to prevent the assessment of any additional income tax, excise tax or penalty on any Recipient because of Code Section 409A and (ii) shall have no such liability to any Recipient for any such taxes or penalty.

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EX-31.1

Exhibit 31.1

CERTIFICATION

I, Gerri A. Henwood, certify that:

1. I have reviewed this Quarterly Report of Recro Pharma, 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;

4. The registrant’s other certifying officer 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 reports (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 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 function):

(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: May 9, 2018

/s/ Gerri A. Henwood

Gerri A. Henwood

President and Chief Executive Officer

(Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

I, Ryan D. Lake, certify that:

1. I have reviewed this Quarterly Report of Recro Pharma, 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;

4. The registrant’s other certifying officer 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 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 function):

(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: May 9, 2018

/s/ Ryan D. Lake

Ryan D. Lake

Chief Financial Officer

(Principal Financial and Accounting Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Recro Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 9, 2018

/s/ Gerri A. Henwood

Gerri A. Henwood

President and Chief Executive Officer

(Principal Executive Officer)

/s/ Ryan D. Lake

Ryan D. Lake

Chief Financial Officer(Principal Financial and Accounting Officer)

XML

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2018	May 07, 2018
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2018
Document Fiscal Year Focus	2018
Document Fiscal Period Focus	Q1
Trading Symbol	REPH
Entity Registrant Name	Recro Pharma, Inc.
Entity Central Index Key	0001588972
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		20,507,616

XML

Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 46,284	$ 60,984
Short-term investments	4,989	3,498
Accounts receivable	9,833	9,686
Contract asset	5,508	3,755
Inventory	10,028	9,839
Prepaid expenses and other current assets	2,686	3,276
Total current assets	79,328	87,283
Property, plant and equipment, net	38,486	39,074
Deferred income taxes	19,989	18,573
Intangible assets, net	34,204	34,850
Goodwill	6,446	6,446
Total assets	178,453	186,226
Current liabilities:
Accounts payable	4,336	7,954
Accrued expenses and other current liabilities	6,361	9,897
Current portion of contingent consideration	33,957	32,053
Total current liabilities	44,654	49,904
Long-term debt, net	53,957	53,598
Warrants and other long-term liabilities	4,290	3,516
Long-term portion of contingent consideration	50,976	50,360
Total liabilities	153,877	157,378
Commitments and contingencies (Note 13)
Shareholders’ equity:
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and outstanding
Common stock, $0.01 par value. Authorized, 50,000,000 shares; issued and outstanding, 19,550,414 shares at March 31, 2018 and 19,127,435 shares at December 31, 2017	195	191
Additional paid-in capital	145,367	140,006
Accumulated deficit	(120,985)	(111,348)
Accumulated other comprehensive loss	(1)	(1)
Total shareholders’ equity	24,576	28,848
Total liabilities and shareholders’ equity	$ 178,453	$ 186,226

XML

Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares	Mar. 31, 2018	Dec. 31, 2017
Statement Of Financial Position [Abstract]
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	50,000,000	50,000,000
Common stock, shares issued	19,550,414	19,127,435
Common stock, shares outstanding	19,550,414	19,127,435

XML

Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Income Statement [Abstract]
Revenue	$ 19,542	$ 18,742
Operating expenses:
Cost of sales (excluding amortization of intangible assets)	10,490	10,498
Research and development	8,442	7,763
General and administrative	9,518	4,032
Amortization of intangible assets	646	646
Change in warrant valuation	773	291
Change in contingent consideration valuation	2,520	2,814
Total operating expenses	32,389	26,044
Operating loss	(12,847)	(7,302)
Other income (expense):
Interest income	142	105
Interest expense	(2,103)	(1,183)
Net loss before income taxes	(14,808)	(8,380)
Income tax benefit	2,353	293
Net loss	$ (12,455)	$ (8,087)
Per share information:
Net loss per share of common stock, basic and diluted	$ (0.65)	$ (0.42)
Weighted average common shares outstanding, basic and diluted	19,219,257	19,049,416
Net Loss	$ (12,455)	$ (8,087)
Other comprehensive loss:
Unrealized loss on available-for-sale securities		(57)
Comprehensive loss	$ (12,455)	$ (8,144)

XML

Consolidated Statements of Shareholders' Equity (Unaudited) - 3 months ended Mar. 31, 2018 - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Loss [Member]
Balance at Dec. 31, 2017	$ 28,848	$ 191	$ 140,006	$ (111,348)	$ (1)
Balance, Shares at Dec. 31, 2017		19,127,435
Stock-based compensation expense	1,584		1,584
Stock option exercise	$ 65		65
Stock option exercise, Shares	14,575	14,575
Issuance of restricted stock units, net of shares withheld for income taxes	$ (86)		(86)
Issuance of restricted stock units, net of shares withheld for income taxes, Shares		25,364
Sale of common stock under equity facility, net of transaction costs	3,802	$ 4	3,798
Sale of common stock under equity facility, net of transaction costs, Shares		383,040
Net loss	(12,455)			(12,455)
Cumulative effect of adoption of new accounting standards, net of tax	2,818			2,818
Balance at Mar. 31, 2018	$ 24,576	$ 195	$ 145,367	$ (120,985)	$ (1)
Balance, Shares at Mar. 31, 2018		19,550,414

XML

Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Cash flows from operating activities:
Net loss	$ (12,455)	$ (8,087)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,584	892
Non-cash interest expense	319	158
Depreciation expense	1,216	1,196
Amortization	646	646
Change in warrant valuation	773	291
Change in contingent consideration valuation	2,520	2,814
Deferred income taxes	(2,353)	(1,235)
Inventory	(189)	936
Contract Asset	(1,753)
Prepaid expenses and other current assets	912	(518)
Accounts receivable	(147)	(1,867)
Accounts payable, accrued expenses and other liabilities	(5,870)	(2,363)
Net cash used in operating activities	(14,797)	(7,137)
Cash flows from investing activities:
Purchase of property and equipment	(1,654)	(1,744)
Purchase of short-term investments	(4,981)	(36,117)
Proceeds from maturity of investments	3,500
Net cash used in investing activities	(3,135)	(37,861)
Cash flows from financing activities:
Payment of deferred financing costs	(261)
Proceeds from sale of common stock, net of transaction costs	3,514
Payments of withholdings on shares withheld for income taxes	(86)
Proceeds from option exercise	65
Net cash provided by financing activities	3,232
Net decrease in cash and cash equivalents	(14,700)	(44,998)
Cash and cash equivalents, beginning of period	60,984	64,483
Cash and cash equivalents, end of period	46,284	19,485
Supplemental disclosure of cash flow information:
Cash paid for interest	2,546	1,026
Purchase of property, plant and equipment included in accrued expenses and accounts payable	249	$ 237
Retirement of fully depreciated property, plant and equipment	30
Common stock issued in connection with equity facility	$ 357

XML

Background

3 Months Ended

Mar. 31, 2018

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Background

(1) Background

Recro Pharma, Inc., or the Company, was incorporated in Pennsylvania on November 15, 2007. The Company is a specialty pharmaceutical company that operates through two business divisions: an Acute Care division and a revenue-generating contract development and manufacturing, or CDMO division. Each of these divisions are deemed to be reportable segments (see Note 3(m) and Note 17). The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings, and the CDMO division leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. On April 10, 2015, the Company acquired from Alkermes plc, or Alkermes, worldwide rights to intravenous and intramuscular, or injectable, meloxicam, a proprietary long-acting preferential COX-2 inhibitor being developed for the management of moderate to severe pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, Georgia. The acquisition is referred to herein as the Gainesville Transaction. In July 2017, the Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or the FDA, for its lead investigational product candidate intravenous, or IV, meloxicam 30 mg for the management of moderate to severe pain. The FDA has accepted the NDA for review and has set a Prescription Drug User Fee Act, or PDUFA, date of May 26, 2018.

XML

Development-Stage Risks and Liquidity

3 Months Ended

Mar. 31, 2018

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Development-Stage Risks and Liquidity

(2) Development-Stage Risks and Liquidity

The Company has incurred losses from operations since inception and has an accumulated deficit of $120,985 as of March 31, 2018. Though its CDMO segment has been profitable, the Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its products currently in development. Additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates, including the payment of the Gainesville Transaction contingent payments, which may become due upon achievement of certain development and commercialization milestones for meloxicam (see Note 4). Insufficient funds may cause the Company to delay, reduce the scope of or eliminate one or more of its development, commercialization or expansion activities. The Company may raise such funds through debt refinancing, bank or other loans, through strategic research and development, licensing (including out-licensing) and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and failure to raise capital when needed could materially adversely impact the Company’s growth plans and its financial condition or results of operations. Additional equity financing, if available, may be dilutive to the holders of its common stock and may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate its business. The Company’s future operations are highly dependent on a combination of factors, including (i) the continued profitability of the CDMO segment; (ii) the timely and successful completion of additional financing and/or alternative sources of capital, debt, partnering or out-licensing transactions; (iii) the success of its research and development, including the results and timing of its clinical trials; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market acceptance of the Company’s proposed future products. Management believes that the Company’s existing cash, cash equivalents and short-term investments as of March 31, 2018 and other expected financing sources will be sufficient to fund its operations over the next twelve months.

XML

Summary of Significant Accounting Principles

3 Months Ended

Mar. 31, 2018

Accounting Policies [Abstract]

Summary of Significant Accounting Principles

(3) Summary of Significant Accounting Principles

(a) Basis of Presentation and Principles of Consolidation

The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2018.

The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

(b) Use of Estimates

The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP 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 revenues and expenses during the reporting period. Actual results could differ from such estimates.

(c) Cash and Cash Equivalents

Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of the changes in interest rates.

(d) Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture and office equipment; six to ten or more years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred.

(e) Business Combinations

In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805, “Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date.

(f) Goodwill and Intangible Assets

Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a two-step method for determining impairment.

The first step compares a reporting unit’s fair value to its carrying amount to identify potential goodwill impairment. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the second step of the impairment test must be completed to measure the amount of the reporting unit’s goodwill impairment loss, if any. Step two requires an assignment of the reporting unit’s fair value to the reporting unit’s assets and liabilities to determine the implied fair value of the reporting unit’s goodwill. The implied fair value of the reporting unit’s goodwill is then compared with the carrying amount of the reporting unit’s goodwill to determine the goodwill impairment loss to be recognized, if any.

Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an IPR&D asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is amortized on a straight-line basis over a useful life of six years.

Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations and Comprehensive Loss. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.

The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a triggering event occurs between annual assessments, which would then require an assessment in the period which a triggering event occurred. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30^th, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. In performing the evaluation, the Company assessed qualitative factors such as overall financial performance of its reporting units, anticipated changes in industry and market conditions, including recent tax reform, and competitive environments. As a result of the latest impairment tests, November 30, 2017, the Company determined that there was no impairment to goodwill or indefinite-lived intangible assets. Additionally, there were no indicators of impairment as of March 31, 2018.

(g) Revenue Recognition

The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components.  The Company’s revenue policies listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “Revenue from Contracts with Customers,” or ASU 2014-09,which the company adopted effective January 1, 2018.  See footnote 18 for additional information regarding the Company’s adoption of ASU 2014-09 and its impact on the Company’s financial statements.

Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments.

In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the commercial partner.  For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of the manufactured product.  In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s commercial partners.

Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received.

(h) Concentration of Credit Risk

Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity.

The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition.

The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four largest customers having generated 99% of its revenues for three months ended March 31, 2018. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the U.S.

(i) Research and Development

Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expenses relating to these costs.

Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use.

(j) Stock-Based Awards

The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award.

Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards.

The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option.

Non-employee stock-based awards are revalued until an award vests and the Company recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, which is known as the accelerated attribution method. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are revised.

(k) Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year.

(l) Net Loss Per Common Share

Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period.  For all periods presented, the outstanding common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive.  

For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.  There are no dilutive common stock equivalents for the three months ended March 31, 2018.

The following table sets forth the computation of basic and diluted loss per share:

	Three Months Ended March 31,
	2018			2017
Basic and Diluted Loss Per Share
Net loss	$	(12,455	)	$	(8,087	)
Weighted average common shares outstanding, basic and diluted		19,219,257			19,049,416
Net loss per share of common stock, basic and diluted	$	(0.65	)	$	(0.42	)

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive:

	March 31,
	2018		2017
Options and restricted stock units outstanding		4,973,043		3,337,461
Warrants		1,133,592		784,928

Amounts in the table above reflect the common stock equivalents of the noted instruments.

(m) Segment Information

The Company determined its reportable segments based on its strategic business units, the commonalities among the products and services within each segment and the manner in which the Company reviews and evaluates operating performance. The Company has identified its CDMO and Acute Care divisions as reportable segments. Segment disclosures are included in Note 17. Segment operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of general and administrative expenses, research and development expenses, and the change in valuation of contingent consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and expense, and income tax benefit. Segment assets are those assets and liabilities that are recorded and reported by segment operations. Segment operating capital employed represents segment assets less segment liabilities.

(n) Recent Accounting Pronouncements

In May 2017, the FASB issued ASU No. 2017-09, “Stock Compensation - Scope of Modification Accounting” or ASU 2017-09.  ASU 2017-09 provides guidance on which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new standard is effective for fiscal years beginning after December 15, 2017. The Company adopted the guidance effective January 1, 2018. There was no impact upon adoption.

In January 2017, the FASB issued ASU No. 2017-04 “Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment,” or ASU 2017-04. ASU 2017-04 allows companies to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The amendments of the ASU are effective for annual or interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” or ASU 2016-02. ASU 2016-02 establishes a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The new guidance is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In January 2018, the Company adopted the standard using the modified retrospective method. See Footnote 18 for additional information on the impact of the transition on the Company’s financial statements.

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Acquisition of Gainesville Facility and Meloxicam

3 Months Ended

Mar. 31, 2018

Gainesville [Member]

Acquisition of Gainesville Facility and Meloxicam

(4) Acquisition of Gainesville Facility and Meloxicam

On April 10, 2015, the Company completed the Gainesville Transaction. The consideration paid in connection with the Gainesville Transaction consisted of $50,000 cash at closing, a $4,000 working capital adjustment and a seven-year warrant to purchase 350,000 shares of the Company’s common stock at an exercise price of $19.46 per share. In addition, the Company may be required to pay up to an additional $125,000 in milestone payments including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and a percentage of future product net sales related to injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent). Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and royalties were allocated to the fair value of the assets acquired and liabilities assumed. The contingent consideration obligation is remeasured each reporting date with changes in fair value recognized as a period charge within the statement of operations (see Note 6 for further information regarding fair value).

The contingent consideration consists of three separate components. The first component will be payable upon regulatory approval. The second component consists of three potential payments, based on the achievement of specified annual revenue targets, the last of which represents over 60% of these milestone payments and currently does not have a fair value assigned to its achievement. The third component consists of a royalty payment between 10% and 12% (subject to a 30% reduction when no longer covered by patent) for a defined term on future meloxicam net sales.

The fair value of the first contingent consideration component recognized on the acquisition date was estimated by applying a risk-adjusted discount rate to the probability-adjusted contingent payments and the expected approval dates. The fair value of the second contingent consideration component recognized on the acquisition date was estimated using the Monte Carlo simulation method and applying a risk-adjusted discount rate to the potential payments resulting from probability-weighted revenue projections based upon the expected revenue target attainment dates. The fair value of the third contingent consideration component recognized on the acquisition date was estimated by applying a risk-adjusted discount rate to the potential payments resulting from revenue projections and the defined royalty percentage.

These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs. The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair value through the results of operations.

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NMB Related License Agreement

3 Months Ended

Mar. 31, 2018

Business Combinations [Abstract]

NMB Related License Agreement

(5) NMB Related License Agreement

In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBs, and a proprietary reversal agent from Cornell University, or Cornell. The NMBs and reversal agent are referred to herein as the NMB Related Compounds. The NMB Related Compounds include one novel intermediate-acting NMB that has initiated Phase I clinical trials and two other agents, a novel short-acting NMB, and a rapid-acting reversal agent specific to these NMBs.

The transaction was accounted for as an asset acquisition, with the total cost of the acquisition of $766 allocated to acquired IPR&D. The Company recorded an upfront payment obligation of $350, as well as operational liabilities and acquisition-related costs of $416, primarily consisting of reimbursement to Cornell for specified past patent, legal and pre-clinical costs, of which $247 is reported as a component of Accrued expenses and other current liabilities and Other non-current liabilities on the Consolidated Balance Sheet as of March 31, 2018.

In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the NMB Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each NMB, of $5,000 for U.S. regulatory approval and commercialization milestones and $3,000 for European regulatory approval and commercialization milestones. The Company is also obligated to pay Cornell royalties on net sales of the NMB Related Compounds at a rate ranging from low to mid-single digits, depending on the applicable NMB Related Compounds and whether there is a valid patent claim in the applicable country, subject to an annual minimum royalty amount. Further, the Company will reimburse Cornell ongoing patent costs related to prosecution and maintenance of the patents related to the Cornell patents for the NMB Related Compounds.

The Company accounted for the transaction as an asset acquisition based on an evaluation of the accounting guidance (ASC Topic 805) and considered the early clinical stage of the novel and unproven NMB Related Compounds. The Company concluded that the acquired IPR&D of Cornell did not constitute a business as defined under ASC 805 due to the incomplete nature of the inputs and the absence of processes from a market participant perspective. Substantial additional research and development will be required to develop any NMB Related Compounds into a commercially viable drug candidate, including completion of pre-clinical testing and clinical trials, and, if such clinical trials are successful, application for regulatory approvals and manufacturing repeatability and scale-up. There is risk that a marketable compound may not be well tolerated and may never be approved.

Acquired IPR&D in the asset acquisition was accounted for in accordance with FASB ASC Topic 730, “Research and Development.” At the date of acquisition, the Company determined that the development of the projects underway at Cornell had not yet reached technological feasibility and that the research in process had no alternative future uses.  Accordingly, the acquired IPR&D was charged to expense in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. The acquired IPR&D charge is expected to be deductible over a 15-year period for income tax purposes.

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Fair Value of Financial Instruments

3 Months Ended

Mar. 31, 2018

Fair Value Disclosures [Abstract]

Fair Value of Financial Instruments

(6) Fair Value of Financial Instruments

The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments, warrants and the contingent consideration. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows:

• Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

• Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and

• Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The Company has classified assets and liabilities measured at fair value on a recurring basis as follows:

	Fair value measurements at reporting date using
	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)
At December 31, 2017:
Assets:
Cash equivalents
Money market mutual funds	$	38,959	$	—	$	—
Total cash equivalents	$	38,959	$	—	$	—
Short-term investments
U.S. Treasury obligations	$	3,498	$	—	$	—
Total financial assets	$	42,457	$	—	$	—
Liabilities:
Warrants		—		—	$	3,406
Contingent consideration		—		—		82,413
	$	—	$	—	$	85,819
At March 31, 2018:
Assets:
Cash equivalents
Money market mutual funds (See Note 7)	$	4,162	$	—	$	—
U.S. Treasury obligations (See Note 7)	$	9,989
Commercial Paper (See Note 7)			$	17,972
Total cash equivalents	$	14,151	$	17,972	$	—
Short-term investments
U.S. Treasury obligations (See Note 7)	$	1,998	$	—	$	—
Commercial Paper (See Note 7)			$	2,991	$	—
Total financial assets	$	16,149	$	20,963	$	—
Liabilities:
Warrants (See Note 14(d))		—		—	$	4,179
Contingent consideration (See Note 4)		—		—		84,933
	$	—	$	—	$	89,112

The Company developed its own assumptions to determine the value of the warrants that do not have observable inputs or available market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common stock, stock price volatility, the contractual term of the warrants, risk free interest rates and dividend yield. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement.  

The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:

	Warrants		Contingent Consideration
Balance at December 31, 2017	$	3,406	$	82,413
Additions		—		—
Remeasurement		773		2,520
Total at March 31, 2018	$	4,179	$	84,933
Current portion as of March 31, 2018		—		33,957
Long-term portion as of March 31, 2018		4,179		50,976

The current portion of the contingent consideration represents the estimated probability adjusted fair value that is expected to become payable within one year as of March 31, 2018 (see Note 4 for additional information).

The Company follows the disclosure provisions of FASB ASC Topic 825, “Financial Instruments” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of March 31, 2018, the financial assets and liabilities recorded on the Consolidated Balance Sheets that are not measured at fair value on a recurring basis include accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of these instruments. The fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of long-term debt approximated fair value at March 31, 2018 due to the comparison of the terms of the debt, including borrowing rates available to the Company through its recent completed debt refinancing process, availability of additional term loan tranches, and maturity.

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Short-term Investments

3 Months Ended

Mar. 31, 2018

Investments Debt And Equity Securities [Abstract]

Short-term Investments

(7) Short-term Investments

Short-term investments as of March 31, 2018 consist of government money market funds, U.S. Treasury obligations and commercial paper. A portion of short term investments is included in Cash and cash equivalents due to its original maturity of three months or less when acquired. In accordance with FASB ASC Topic 320, “Investments – Debt and Equity Securities,” the Company has classified its entire investment portfolio as available-for-sale securities with secondary or resale markets, and, as such, its portfolio is reported at fair value with unrealized gains and losses included in Comprehensive Income in stockholders’ equity and realized gains and losses included in other income/expense. The following is a summary of available-for-sale securities as of March 31, 2018.

	March 31, 2018
	Amortized		Gross Unrealized					Estimated
Description	Cost		Gain		Loss			Fair Value
Money market mutual funds	$	4,162	$	—	$	—		$	4,162
U.S. Treasury obligations		11,987		—		—			11,987
Commercial Paper		20,963		1		(1	)		20,963
Total investments	$	37,112	$	1	$	(1	)	$	37,112

As of March 31, 2018, the Company’s investments had maturities ranging from one to four months. As of December 31, 2017, all of the Company’s investments in U.S. Treasury obligations had original maturities of less than two months. The fair value of the Company’s U.S. Treasury obligations is determined by taking into consideration valuations obtained from third-party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, and other observable inputs. To derive the fair value of its commercial paper, the Company uses benchmark inputs and industry standard analytical models.

Certain investment securities as of March 31, 2018 had fair values less than their amortized costs and, therefore, contained unrealized losses. The Company has evaluated these investments and has determined that the decline in value was not related to any Company or industry specific event. As of March 31, 2018, there were two investments with unrealized losses. The gross unrealized losses related to these investments were due to changes in interest rates. Given that the Company has no intent to sell any of these investments until a recovery of its fair value, which may be at maturity, and there are no current requirements to sell any of these investments, the Company did not consider these investments to be other-than-temporarily impaired as of March 31, 2018. The Company anticipates full recovery of amortized costs with respect to these investments at maturity or sooner in the event of a more favorable market interest rate environment. The duration of time the investments had been in a continuous unrealized loss position as of March 31, 2018 was less than six months.

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Inventory

3 Months Ended

Mar. 31, 2018

Inventory Disclosure [Abstract]

Inventory

(8) Inventory

Inventory is stated at the lower of cost and net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Cost is determined using the first-in, first-out method. The Company expenses costs related to inventory until such time as it receives approval from the FDA to market a product, at which time the Company commences capitalization of costs relating to that product.

Inventory was as follows as of March 31, 2018 and December 31, 2017:

	March 31, 2018			December 31, 2017
Raw materials	$	2,645		$	2,130
Work in process		4,672			3,931
Finished goods		3,551			4,488
		10,868			10,549
Provision for inventory obsolescence		(840	)		(710	)
	$	10,028		$	9,839

Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Inventory is ordered to meet specific customer orders and largely reflects demand. Factors influencing inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns.

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Property, Plant and Equipment

3 Months Ended

Mar. 31, 2018

Property Plant And Equipment [Abstract]

Property, Plant and Equipment

(9) Property, Plant and Equipment

Property, plant and equipment consists of the following:

	March 31, 2018		December 31, 2017
Land	$	3,263	$	3,263
Building and improvements		15,771		15,751
Furniture, office and computer equipment		4,633		4,406
Manufacturing equipment		24,603		24,153
Construction in progress		5,227		5,326
		53,497		52,899
Less: accumulated depreciation and amortization		15,011		13,825
Property, plant and equipment, net	$	38,486	$	39,074

Depreciation expense for the three months ended March 31, 2018 and 2017 was $1,216 and $1,196, respectively.

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Intangible Assets

3 Months Ended

Mar. 31, 2018

Goodwill And Intangible Assets Disclosure [Abstract]

Intangible Assets

(10) Intangible Assets

The following represents the balance of the intangible assets at March 31, 2018:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,696	$	7,804
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,696	$	34,204

The following represents the balance of intangible assets at December 31, 2017:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,050	$	8,450
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,050	$	34,850

Amortization expense for each of the three months ended March 31, 2018 and 2017 was $646.

As of March 31, 2018, future amortization expense is as follows:

	Amortization
2018		1,937
2019		2,583
2020		2,583
2021		701
Total	$	7,804

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Accrued Expenses and Other Current Liabilities

3 Months Ended

Mar. 31, 2018

Payables And Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

(11) Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

	March 31,		December 31,
	2018		2017
Clinical trial and related costs	$	367	$	383
Professional and consulting fees		926		1,010
Payroll and related costs		3,247		6,387
Property plant and equipment		6		216
Deferred revenue		818		546
Interest payable		—		802
Other		997		553
	$	6,361	$	9,897

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Long-Term Debt

3 Months Ended

Mar. 31, 2018

Debt Disclosure [Abstract]

Long-Term Debt

(12) Long-Term Debt

On November 17, 2017, the Company entered into a $10,000 Credit Agreement, or the Credit Agreement, with Athyrium Opportunities III Acquisition LP, or Athyrium. The Credit Agreement provides for an initial term loan in the original principal amount of $60,000 funded at closing. Pursuant to the terms of the Credit Agreement, there are two additional tranches of term loans, each in an aggregate original principal amount of $20,000. The second tranche term loan may be drawn upon on or before December 31, 2018 provided that the Company receives regulatory approval of the Company’s IV meloxicam product candidate and will have at least $20,000 in unrestricted cash after payment of the milestone payment due to Alkermes. The third tranche term loan may be drawn upon at any time on or prior to March 31, 2020 provided that the second term loan has been drawn upon and net sales of IV Meloxicam achieve $20,000 for the most recent trailing twelve-month period. The maturity date of the Credit Agreement is November 17, 2022, the five-year anniversary of the closing.

The Term Loans will bear interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum, with quarterly, interest-only payments until the maturity date. The unpaid principal amount of the Term Loans is due and payable on the maturity date. In addition, in accordance with the Credit Agreement the Company will have to pay a 1% exit fee of $600, which will be accreted to the carrying amount of the debt using the effective interest method over the term of the loan. In addition, if there is an early repayment, there is a sliding scale of prepayment penalties.

The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis. As of March 31, 2018, the Company was in compliance with the covenants.

As of March 31, 2018, the remaining payments due under the Credit Agreement include a principal payment of $60,000 and an exit fee of $600 due at the maturity date.

In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP, or Athyrium II, to purchase an aggregate of 348,664 shares of the Company’s common stock with an exercise price of $8.6043 per share. See Note 14(d) for additional information. The warrants are exercisable through November 17, 2024. The initial fair value of the warrant of $2,143 was recorded as a debt issuance cost.  

In addition, the Company recorded debt issuance costs for the Credit Agreement of $4,439, which, along with the fair value of warrants, are being amortized using the effective interest method over the term of the Credit Agreement. Debt issuance cost amortization is included in interest expense within the Consolidated Statements of Operations and Comprehensive Loss. As of March 31, 2018, the effective interest rate was 15.04%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt issuance cost.

The components of the carrying value of the debt as of March 31, 2018, are detailed below:

Principal balance outstanding	$	60,000
Unamortized deferred issuance costs		(6,088	)
Exit fee accretion		45
Total	$	53,957

The Company used proceeds from the $60,000 initial term loan to (i) repay in full all outstanding indebtedness under its previous credit facility governed by the Credit Agreement, dated April 10, 2015, between the Company’s subsidiary, Recro Gainesville LLC and OrbiMed Royalty Opportunities II, LP, or the OrbiMed Credit Agreement of $31,767, which included the remaining debt principal balance of $27,347 and early termination charges of $4,420 and (ii) pay transaction fees associated with the Athyrium Credit Agreement of $4,178.

Associated with the refinancing of the OrbiMed Credit Agreement and in accordance with ASC 405-20 “Extinguishments of Liabilities”, the Company booked one-time loss on extinguishment of $6,772 as of December 31, 2017, which was reflected in the interest expense line within the Consolidated Statement of Operations and Comprehensive Loss.

The Company recorded debt issuance cost amortization for both credit agreements of $329 and $158 for the three months ended March 31, 2018 and 2017, respectively.

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Commitments and Contingencies

3 Months Ended

Mar. 31, 2018

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingencies

(13) Commitments and Contingencies

(a) Licenses

The Company is party to an exclusive license with Orion for the development and commercialization of Dexmedetomidine, or Dex, for use in the treatment of pain in humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational) delivery, but specifically excluding delivery vehicles for administration by injection or infusion, worldwide, except for Europe, Turkey and the CIS (currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan), referred to herein as the Territory. The Company is required to pay Orion lump sum payments of up to €20,500 ($25,257 as of March 31, 2018) on the achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 20% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved.

The Company is also party to an exclusive license agreement with Orion for the development and commercialization of Fadolmidine, or Fado, for use as a human therapeutic, in any dosage form in the Territory. The Company is required to pay Orion lump sum payments of up to €12,200 ($15,031 as of March 31, 2018) on achievement of certain developmental and commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 15% depending on annual sales levels. Through March 31, 2018, no such milestones have been achieved.

The Company is party to a license agreement with Cornell University for the exclusive license of the NMB Related Compounds. Under the terms of the agreement, the Company will pay Cornell an initial upfront fee and Cornell is also entitled to receive additional milestone payments, annual license maintenance fees as well as royalties. See Note 5 for further information regarding these payment obligations.

(b) Contingent Consideration for the Gainesville Transaction

Pursuant to the purchase and sale agreement governing the Gainesville Transaction, the Company agreed to pay to Alkermes up to an additional $125,000 in milestone payments including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and royalties on future product sales of injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent).

The Company is party to a Development, Manufacturing and Supply Agreement, or Supply Agreement, with Alkermes (through a subsidiary of Alkermes), pursuant to which Alkermes will (i) provide clinical and commercial bulk supplies of injectable meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls section of an NDA for injectable meloxicam. Pursuant to the Supply Agreement, Alkermes will supply the Company with such quantities of bulk injectable meloxicam formulation as shall be reasonably required for the completion of clinical trials of injectable meloxicam. During the term of the Supply Agreement, the Company will purchase its clinical and commercial supplies of bulk injectable meloxicam formulation exclusively from Alkermes, subject to certain exceptions, for a period of time.

(c) Litigation

The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations.

As part of the Gainesville Transaction, the Company acquired the rights to Zohydro ER®, which the Company licenses to its commercial partner Pernix Therapeutics, Inc., or Pernix, in the United States, and which is subject to ongoing intellectual property litigation and proceedings.

Zohydro ER® has been subject to four paragraph IV certifications with Actavis plc, or Actavis, regarding the filing of Abbreviated NDAs, or ANDAs, with the FDA for a generic version of Zohydro ER®, the filing of a supplemental ANDA, one of the Company’s issued patents relating to a formulation of Zohydro ER®. These certification notices alleged that the three U.S. patents listed in the FDA’s Orange Book for Zohydro ER® will not be infringed by Actavis’ proposed products, are invalid and/or are unenforceable. In 2014 and 2015, the Company, by itself and through Daravita Limited (a subsidiary of Alkermes and the Company’s predecessor in interest), filed two suits against Actavis in the U.S. District Court for the District of Delaware based on the ANDAs and the sANDA, respectively. In February 2017, the District Court in the Actavis case ruled in the Company’s favor and enjoined Actavis from selling the proposed generic version of Zohydro ER®, which Actavis subsequently appealed to the U.S. Court of Appeals for the Federal Circuit. In October 2017, the Company filed suit against Actavis in the U.S. District Court for the District of Delaware based upon another issued patent relating to a formulation of Zohydro ER®. All litigation with Actavis settled in January 2018 via a multi-party settlement agreement among the Company, Pernix and Actavis, in which Actavis was granted a license to begin selling a generic version of Zohydro® ER on March 1, 2029, or earlier under certain circumstances.

(d) Leases

On January 1, 2017, the Company entered into a six-year lease for its Malvern, Pennsylvania facility that expires on December 31, 2022. In February 2017, the Company also entered into a three-year lease for office space in Dublin, Ireland that expires April 2020. The Company is also a party to operating leases for office equipment and storage. Rent expense includes rent as well as additional operating and tenant improvement expenses.

As of March 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the leases, are as follows:

	Lease payments
2018		411
2019		508
2020		408
2021		362
2022		374
Total	$	2,063

(e) Purchase Commitments

As of March 31, 2018, the Company had outstanding non-cancelable and cancelable purchase commitments in the aggregate amount of $27,228 related to inventory, capital expenditures and other goods and services, including pre-commercial/manufacturing scale-up and clinical activities.

(f) Certain Compensation and Employment Agreements

The Company has entered into employment agreements with certain of its named executive officers. As of March 31, 2018, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $734, from that date through calendar year 2018.

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Capital Structure

3 Months Ended

Mar. 31, 2018

Equity [Abstract]

Capital Structure

(14) Capital Structure

(a) Common Stock

The Company is authorized to issue 50,000,000 shares of common stock, with a par value of $0.01 per share.

Reflected below are the Company’s capital raises since its initial public offering, or IPO:

On March 12, 2014, the Company completed an initial public offering, or IPO, in which the Company sold 4,312,500 shares of common stock at $8.00 per share, resulting in gross proceeds of $34,500. In connection with the IPO, the Company paid $4,244 in underwriting discounts, commissions and offering costs, resulting in net proceeds of $30,256. Also in connection with the IPO, all of the outstanding shares of the Company’s Series A Redeemable Convertible Preferred Stock, including accreted dividends, and Bridge Notes, including accrued interest, were converted into common stock.

On July 7, 2015, the Company closed a private placement with certain accredited investors in which the Company sold 1,379,311 shares of common stock at a price of $11.60 per share, for net proceeds of $14,812. The Company paid the placement agents a fee equal to 6.0% of the aggregate gross proceeds from the private placement, plus reimbursement of certain expenses.

On August 19, 2016, the Company closed an underwritten public offering in which the company sold 1,986,666 shares of common stock at a price per share of $7.50, for net proceeds of $13,367 after deducting underwriting commissions and offering expenses. 

On December 16, 2016, the Company closed an underwritten public offering in which the company sold 6,670,000 shares of common stock at a price per share of $6.00, for net proceeds of $36,888 after deducting underwriting commissions and offering expenses.

On December 29, 2017, the Company entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which the Company may sell from time to time, at its option, shares of its common stock, $0.01 par value per share, having an aggregate offering price of up to $40,000 through Cowen, as the placement agent. As of March 31, 2018, the Company did not have any sales of common stock under the Sales Agreement.

(b) Common Stock Purchase Agreement

On February 2, 2015, the Company entered into a Common Stock Purchase Agreement, or the 2015 Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, pursuant to which Aspire Capital was committed to purchase, at the Company’s election, up to an aggregate of $10,000 of shares of the Company’s common stock over the 24-month term of the 2015 Purchase Agreement. On the execution of the 2015 Purchase Agreement, the Company issued 96,463 shares of common stock to Aspire Capital with a fair value of $285, as consideration for entering in the 2015 Purchase Agreement. In addition, the Company incurred $253 of costs in connection with the 2015 Purchase Agreement, which, along with the fair value of the common stock, has been recorded as deferred equity costs. During 2016, the Company sold 1,143,940 shares of common stock under the 2015 Purchase Agreement for $7,796. The agreement expired in February 2017.

On March 2, 2018, the Company entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth in the Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate of $20,000 of  shares of the Company’s common stock over the approximately 30-month term of the Purchase Agreement. On the execution of the Purchase Agreement, the Company agreed to issue 33,040 shares of common stock to Aspire Capital as consideration for entering into the Purchase Agreement. As of March 31, 2018, the Company sold 350,000 shares of common stock under the Purchase Agreement for proceeds of $3,514.

(c) Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.01 per share. As of March 31, 2018, no preferred stock was issued or outstanding.

(d) Warrants

As of March 31, 2018, the Company had the following warrants outstanding to purchase shares of the Company’s common stock:

Number of Shares	Exercise Price per Share		Expiration Date
140,000	$	12.00	March 2019
350,000	$	19.46	April 2022
294,928	$	3.28	April 2022
348,664	$	8.60	November 2024

The warrants to purchase 140,000 and 348,664 shares related to Aegis Capital Corporation and Athyrium, respectively, are equity classified.

The warrants to purchase 350,000 and 294,928 shares related to Alkermes and OrbiMed, respectively, are liability classified since they contain a contingent net cash settlement feature. The fair value of both warrants will be remeasured through settlement or expiration with changes in fair value recognized as a period charge within the statement of operations.

The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for these liability classified warrants.

	March 31, 2018			December 31, 2017
Fair value	$	4,179		$	3,406
Expected dividend yield		—	%		—	%
Expected volatility	74		%	75		%
Risk-free interest rates	2.48		%	2.09		%
Remaining contractual term	4.00 years			4.25 years

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Comprehensive Loss

3 Months Ended

Mar. 31, 2018

Comprehensive Income Net Of Tax [Abstract]

Comprehensive Loss

(15) Comprehensive Loss

The Company’s comprehensive loss is shown on the Consolidated Statements of Operations and Comprehensive Loss as of March 31, 2018, and is comprised of net unrealized gains and losses on the Company’s available-for-sale securities. The total of comprehensive loss for the three months ended March 31, 2018 and 2017 was $12,455 and $8,144, respectively. There was no tax effect of other comprehensive loss for the three months ended March 31, 2018. The tax effect of other comprehensive loss for the three months ended March 31, 2017 was $19.

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Stock-Based Compensation

3 Months Ended

Mar. 31, 2018

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Stock-Based Compensation

(16) Stock-Based Compensation

The Company established the 2008 Stock Option Plan, or the 2008 Plan, which allows for the granting of common stock awards, stock appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common stock to designated employees, non-employee directors, and consultants and advisors. As of March 31, 2018, no stock appreciation rights have been issued. Subsequent to adoption, the 2008 Plan was amended to increase the authorized number of shares available for grant to 444,000 shares of common stock. In October 2013, the Company established the 2013 Equity Incentive Plan, or the 2013 Plan, which allows for the grant of stock options, stock appreciation rights and stock awards for a total of 600,000 shares of common stock. In June 2015, the Company’s shareholders approved the Amended and Restated Equity Incentive Plan, or the A&R Plan, which amended and restated the 2013 Plan and increased the aggregate amount of shares available for issuance to 2,000,000. On December 1^st of each year, pursuant to the “Evergreen” provision of the A&R Plan, the number of shares available under the plan may be increased by the board of directors by an amount equal to 5% of the outstanding common stock on December 1^st of that year. In December 2017 and 2016, the number of shares available for issuance under the A&R Plan was increased by 956,341 and 619,181, respectively. The total number of shares authorized for issuance under the A&R plan as of March 31, 2018 is 4,036,737. In May 2018, the Company’s shareholders approved the 2018 Amended and Restated Equity Incentive Plan, which amended and restated the A&R Plan to increase the aggregate amount of shares available for issuance to 7,036,737.

Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of March 31, 2018, 254,420 shares and 174 shares are available for future grants under the A&R Plan and 2008 Plan, respectively.

The weighted average grant-date fair value of the options awarded to employees during the three months ended March 31, 2018 and 2017 was $6.08 and $5.29, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions:

	March 31,
	2018		2017
Range of expected option life	6 years		6 years
Expected volatility	74.01% - 74.60%		84.71%
Risk-free interest rate	2.32 - 2.73%		2.05 - 2.17%
Expected dividend yield		—		—

The following table summarizes stock option activity during the three months ended March 31, 2018:

	Number of shares			Weighted average exercise price		Weighted average remaining contractual life
Balance, December 31, 2017		3,594,875		$	7.17	7.1 years
Granted		713,226			9.16
Exercised		(14,575	)		4.49
Expired/forfeited/cancelled		(46,805	)		8.51
Balance, March 31, 2018		4,246,721		$	7.50	7.3 years
Vested		2,213,374		$	6.82	5.7 years
Vested and expected to vest		4,246,721		$	7.50	7.3 years

Included in the table above are 961,750 options granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).

During the year ending December 31, 2016, the Company adopted ASU 2016-09 and elected to account for forfeitures as they occur.

The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2018.

	Number of shares
Balance, December 31, 2017		270,593
Granted		500,120
Vested and settled		(35,025	)
Expired/forfeited/cancelled		(9,366	)
Balance, March 31, 2018		726,322
Expected to vest		726,322

Included in the table above are 44,500 time-based RSUs granted outside the plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).

In March 2018, the Company granted 240,224 performance-based RSUs, which may vest based on attaining 2018 financial, clinical and operational goals, as well as 259,896 time-based RSUs, which vest over four years.

Stock-based compensation expense for the three months ended March 31, 2018 and 2017 was $1,584 and $892, respectively.

As of March 31, 2018, there was $14,870 of unrecognized compensation expense related to unvested options and time-based RSUs that are expected to vest and will be expensed over a weighted average period of 2.6 years. As of March 31, 2018, there was $2,671 of unrecognized compensation expense related to unvested performance-based RSUs and will be expensed when the performance criteria are met.

The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the exercise price of the related options. As of March 31, 2018, the aggregate intrinsic value of the vested and unvested options was $9,522 and $5,746, respectively.

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Segment Reporting

3 Months Ended

Mar. 31, 2018

Segment Reporting [Abstract]

Segment Reporting

(17) Segment Reporting

The Company operates through two business divisions that are treated as separate financial segments: an Acute Care segment and a revenue-generating CDMO segment. The Acute Care segment is primarily focused on developing innovative products for hospital and related settings, and the CDMO segment leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these products. Acute Care has no revenue, and its costs consist primarily of expenses incurred in conducting the Company’s clinical and preclinical studies, acquiring clinical trial materials, regulatory activities, personnel costs and pre-commercialization of meloxicam. CDMO revenue streams are derived from manufacturing, royalty revenues, as well as CDMO’s research and development services performed for commercial partners.

The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note 3). The Company evaluates performance of its reportable segments based on revenue and operating income (loss). The Company does not allocate interest income, interest expense or income taxes to its operating segments.

The following table summarizes segment information as of and for the three months ended March 31, 2018:

	For the Three Months Ended March 31,
	2018			2017
Revenues:
CDMO	$	19,542		$	18,742
Acute Care		—			—
Total	$	19,542		$	18,742
Operating income (loss):
CDMO	$	6,566		$	6,199
Acute Care		(19,413	)		(13,501	)
Total	$	(12,847	)	$	(7,302	)
Depreciation and amortization:
CDMO	$	1,819		$	1,837
Acute Care		43			5
Total	$	1,862		$	1,842
Capital expenditures:
CDMO	$	329		$	1,530
Acute Care		1,325			214
Total	$	1,654		$	1,744

	March 31,		December 31,
	2018		2017
Total assets:
CDMO	$	80,300	$	78,136
Acute Care		98,153		108,090
Total	$	178,453	$	186,226

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Revenue Recognition

3 Months Ended

Mar. 31, 2018

Revenue From Contract With Customer [Abstract]

Revenue Recognition

(18)  Revenue Recognition

Effective January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method applied to contracts existing as of January 1, 2018.  Results for reporting periods beginning after January 1, 2018 are presented under the new guidance while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance.  See Note 3 for additional information on the Company’s revenue recognition policies.

The Company uses the practical expedient to not account for significant financing components because the period between recognition and collection does not exceed one year in any contract.

Upon adoption, the Company recorded a decrease of $2,818 to the opening balance of accumulated deficit as of January 1, 2018. This adjustment resulted from a change in revenue recognition associated with a variable portion of certain of its royalty revenue.  Under the new accounting standard, estimated royalty revenue to be received in the future that is deemed predominantly related to product sales rather than the license for intellectual property, is included as a component of the product sale transaction consideration to the extent such consideration is not probable to significant reversal.  Prior to adoption of the new guidance, the Company recognized this royalty revenue in the period the products were sold by the commercial partner.

The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09 were as follows:

	Balance at December 31, 2017		Adoption of ASU 2014-09			Balance at January 1, 2018
Contract asset	$	—	$	3,755		$	3,755
Deferred income taxes		18,573		(937	)		17,636
Total shareholders' equity		28,848		(2,818	)		26,030

The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed consolidated balance sheet was as follows:

	For the Three Months Ended March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Revenue	$	17,789		$	1,753		$	19,542
Income tax benefit		2,790			(437	)		2,353
Net loss		(13,771	)		1,316			(12,455	)

	March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Contract assets	$	—		$	5,508		$	5,508
Deferred income taxes		21,363			(1,374	)		19,989
Total assets		174,319			4,134			178,453
Accumulated deficit		(125,119	)		4,134			(120,985	)
Total shareholders' equity		20,442			4,134			24,576
Total liabilities and shareholders' equity		174,319			4,134			178,453

Contract assets represent revenue recognized for performance obligations completed before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract assets were $5,508 and $3,755 at March 31, 2018 and January 1, 2018, respectively. Generally, the contract assets balance is impacted by the recognition of additional contract assets, offset by amounts invoiced to customers or actual net product sale amounts reported by the commercial partner for the period. For the three months ended March 31, 2018, actual net product sale amounts reported by the Company’s commercial partner exceeded estimates of royalty amounts attributed to manufactured product shipped as of January 1, 2018 for the related arrangements by approximately $817. 

The following table presents changes in the Company’s contract assets for the three months ended March 31, 2018:

Contract asset, beginning of year	$	3,755
Change in estimate arising from changes in transaction price		817
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional		(4,572	)
Contract assets recognized		5,508
Contract asset, end of period	$	5,508

The following table disaggregates revenue by business segment and timing of revenue recognition:

	For the Three Months Ended March 31, 2018
	Point in time		Overtime		Total
CDMO	$	19,413	$	129	$	19,542
Acute Care		—		—		—
Revenue		19,413		129		19,542

Adoption of ASU 2014-09 did not require capitalization of any costs to obtain or fulfill contracts. In general, the Company’s payment terms for manufacturing revenue and research and development services is 30 days.  Royalty revenue is recorded to accounts receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment terms are generally 45 days after quarter end.  Based on the adoption of ASU 2014-09, the timing difference between recognition of certain royalty revenues as a contract asset and cash receipt is increased by an estimated 90 days.

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Related Party Transactions

3 Months Ended

Mar. 31, 2018

Related Party Transactions [Abstract]

Related Party Transactions

(19) Related Party Transactions

A Non-Executive Director of the Company’s Irish subsidiary is a Managing Director and a majority shareholder of HiTech Health Ltd, or HiTech Health, a consultancy firm for the biotech, pharmaceutical and medical device industry. Since 2016, HiTech Health has provided the Company with certain consulting services and in November 2017 both parties entered into a Service Agreement to engage in regulatory project support and consultancy. In consideration for such services, the Company recorded $109 for the three months ended March 31, 2018.  A portion of the amount relates to consultancy services provided by the Non-Executive Director.

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Retirement Plan

3 Months Ended

Mar. 31, 2018

Compensation And Retirement Disclosure [Abstract]

Retirement Plan

(20)   Retirement Plan

The Company has a voluntary 401(k) Savings Plan (the 401(k) Plan) in which all employees are eligible to participate. The Company’s policy is to match 100% of the employee contributions up to a maximum of 5% of employee compensation. Total Company contributions to the 401(k) plan for the three months ended March 31, 2018 and 2017 were $390 and $343,  respectively.

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Summary of Significant Accounting Principles (Policies)

3 Months Ended

Mar. 31, 2018

Accounting Policies [Abstract]

Basis of Presentation and Principles of Consolidation

(a) Basis of Presentation and Principles of Consolidation

The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for the three months ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2018.

The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

Use of Estimates

(b) Use of Estimates

The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP 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 revenues and expenses during the reporting period. Actual results could differ from such estimates.

Cash and Cash Equivalents

(c) Cash and Cash Equivalents

Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value because of the changes in interest rates.

Property and Equipment

(d) Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture and office equipment; six to ten or more years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are expensed as incurred.

Business Combinations

(e) Business Combinations

In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805, “Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date.

Goodwill and Intangible Assets

(f) Goodwill and Intangible Assets

Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment model prescribes a two-step method for determining impairment.

The first step compares a reporting unit’s fair value to its carrying amount to identify potential goodwill impairment. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the second step of the impairment test must be completed to measure the amount of the reporting unit’s goodwill impairment loss, if any. Step two requires an assignment of the reporting unit’s fair value to the reporting unit’s assets and liabilities to determine the implied fair value of the reporting unit’s goodwill. The implied fair value of the reporting unit’s goodwill is then compared with the carrying amount of the reporting unit’s goodwill to determine the goodwill impairment loss to be recognized, if any.

Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an IPR&D asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is amortized on a straight-line basis over a useful life of six years.

Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations and Comprehensive Loss. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.

The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a triggering event occurs between annual assessments, which would then require an assessment in the period which a triggering event occurred. The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30^th, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. In performing the evaluation, the Company assessed qualitative factors such as overall financial performance of its reporting units, anticipated changes in industry and market conditions, including recent tax reform, and competitive environments. As a result of the latest impairment tests, November 30, 2017, the Company determined that there was no impairment to goodwill or indefinite-lived intangible assets. Additionally, there were no indicators of impairment as of March 31, 2018.

Revenue Recognition

(g) Revenue Recognition

The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners provide for manufacturing revenues, sales-based royalties and/or profit sharing components.  The Company’s revenue policies listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “Revenue from Contracts with Customers,” or ASU 2014-09,which the company adopted effective January 1, 2018.  See footnote 18 for additional information regarding the Company’s adoption of ASU 2014-09 and its impact on the Company’s financial statements.

Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include pricing and volume based adjustments.

In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the commercial partner.  For arrangements that include sales-based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of the manufactured product.  In these cases, significant judgement is required to calculate this estimated variable consideration using the most-likely amount method based on historical customer pricing, sales deductions and is partially constrained due to items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s commercial partners.

Revenues related to research and development are generally recognized over-time as the related services or activities are performed using the output method and in accordance with the contract terms. In agreements which specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations would be deferred and recognized over the period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received.

Concentration of Credit Risk

(h) Concentration of Credit Risk

Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity.

The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition.

The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four largest customers having generated 99% of its revenues for three months ended March 31, 2018. A portion of the Company’s revenues are dependent on U.S. based customers selling to end-users outside the U.S.

Research and Development

(i) Research and Development

Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred. Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expenses relating to these costs.

Upfront and milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no alternative future use.

Stock-Based Awards

(j) Stock-Based Awards

The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award.

Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards.

The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option.

Non-employee stock-based awards are revalued until an award vests and the Company recognizes compensation expense on a straight-line basis over the vesting period of each separated vesting tranche of the award, which is known as the accelerated attribution method. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are revised.

Income Taxes

(k) Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year.

Net Income Per Common Share

(l) Net Loss Per Common Share

Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average common shares outstanding during the period.  For all periods presented, the outstanding common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive.  

For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.  There are no dilutive common stock equivalents for the three months ended March 31, 2018.

The following table sets forth the computation of basic and diluted loss per share:

	Three Months Ended March 31,
	2018			2017
Basic and Diluted Loss Per Share
Net loss	$	(12,455	)	$	(8,087	)
Weighted average common shares outstanding, basic and diluted		19,219,257			19,049,416
Net loss per share of common stock, basic and diluted	$	(0.65	)	$	(0.42	)

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive:

	March 31,
	2018		2017
Options and restricted stock units outstanding		4,973,043		3,337,461
Warrants		1,133,592		784,928

Amounts in the table above reflect the common stock equivalents of the noted instruments.

Segment Information

(m) Segment Information

The Company determined its reportable segments based on its strategic business units, the commonalities among the products and services within each segment and the manner in which the Company reviews and evaluates operating performance. The Company has identified its CDMO and Acute Care divisions as reportable segments. Segment disclosures are included in Note 17. Segment operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of general and administrative expenses, research and development expenses, and the change in valuation of contingent consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and expense, and income tax benefit. Segment assets are those assets and liabilities that are recorded and reported by segment operations. Segment operating capital employed represents segment assets less segment liabilities.

Recent Accounting Pronouncements

(n) Recent Accounting Pronouncements

In May 2017, the FASB issued ASU No. 2017-09, “Stock Compensation - Scope of Modification Accounting” or ASU 2017-09.  ASU 2017-09 provides guidance on which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new standard is effective for fiscal years beginning after December 15, 2017. The Company adopted the guidance effective January 1, 2018. There was no impact upon adoption.

In January 2017, the FASB issued ASU No. 2017-04 “Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment,” or ASU 2017-04. ASU 2017-04 allows companies to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The amendments of the ASU are effective for annual or interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” or ASU 2016-02. ASU 2016-02 establishes a wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. The new guidance is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect that this guidance may have on its consolidated financial statements.

In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In January 2018, the Company adopted the standard using the modified retrospective method. See Footnote 18 for additional information on the impact of the transition on the Company’s financial statements.

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Summary of Significant Accounting Principles (Tables)

3 Months Ended

Mar. 31, 2018

Accounting Policies [Abstract]

Computation of Basic and Diluted Loss Per Share

The following table sets forth the computation of basic and diluted loss per share:

	Three Months Ended March 31,
	2018			2017
Basic and Diluted Loss Per Share
Net loss	$	(12,455	)	$	(8,087	)
Weighted average common shares outstanding, basic and diluted		19,219,257			19,049,416
Net loss per share of common stock, basic and diluted	$	(0.65	)	$	(0.42	)

Schedule of Anti-Dilutive Securities

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of March 31, 2018 and 2017, as they would be anti-dilutive:

	March 31,
	2018		2017
Options and restricted stock units outstanding		4,973,043		3,337,461
Warrants		1,133,592		784,928

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Fair Value of Financial Instruments (Tables)

3 Months Ended

Mar. 31, 2018

Fair Value Disclosures [Abstract]

Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis

The Company has classified assets and liabilities measured at fair value on a recurring basis as follows:

	Fair value measurements at reporting date using
	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)
At December 31, 2017:
Assets:
Cash equivalents
Money market mutual funds	$	38,959	$	—	$	—
Total cash equivalents	$	38,959	$	—	$	—
Short-term investments
U.S. Treasury obligations	$	3,498	$	—	$	—
Total financial assets	$	42,457	$	—	$	—
Liabilities:
Warrants		—		—	$	3,406
Contingent consideration		—		—		82,413
	$	—	$	—	$	85,819
At March 31, 2018:
Assets:
Cash equivalents
Money market mutual funds (See Note 7)	$	4,162	$	—	$	—
U.S. Treasury obligations (See Note 7)	$	9,989
Commercial Paper (See Note 7)			$	17,972
Total cash equivalents	$	14,151	$	17,972	$	—
Short-term investments
U.S. Treasury obligations (See Note 7)	$	1,998	$	—	$	—
Commercial Paper (See Note 7)			$	2,991	$	—
Total financial assets	$	16,149	$	20,963	$	—
Liabilities:
Warrants (See Note 14(d))		—		—	$	4,179
Contingent consideration (See Note 4)		—		—		84,933
	$	—	$	—	$	89,112

Reconciliation of Contingent Consideration and Warrants Measured at Fair Value on Recurring Basis Using Unobservable Inputs

The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:

	Warrants		Contingent Consideration
Balance at December 31, 2017	$	3,406	$	82,413
Additions		—		—
Remeasurement		773		2,520
Total at March 31, 2018	$	4,179	$	84,933
Current portion as of March 31, 2018		—		33,957
Long-term portion as of March 31, 2018		4,179		50,976

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Short-term Investments (Tables)

3 Months Ended

Mar. 31, 2018

Investments Debt And Equity Securities [Abstract]

Summary of Available-for-sale Securities

The following is a summary of available-for-sale securities as of March 31, 2018.

	March 31, 2018
	Amortized		Gross Unrealized					Estimated
Description	Cost		Gain		Loss			Fair Value
Money market mutual funds	$	4,162	$	—	$	—		$	4,162
U.S. Treasury obligations		11,987		—		—			11,987
Commercial Paper		20,963		1		(1	)		20,963
Total investments	$	37,112	$	1	$	(1	)	$	37,112

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Inventory (Tables)

3 Months Ended

Mar. 31, 2018

Inventory Disclosure [Abstract]

Components of Inventory

Inventory was as follows as of March 31, 2018 and December 31, 2017:

	March 31, 2018			December 31, 2017
Raw materials	$	2,645		$	2,130
Work in process		4,672			3,931
Finished goods		3,551			4,488
		10,868			10,549
Provision for inventory obsolescence		(840	)		(710	)
	$	10,028		$	9,839

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Property, Plant and Equipment (Tables)

3 Months Ended

Mar. 31, 2018

Property Plant And Equipment [Abstract]

Schedule of Property, Plant and Equipment

Property, plant and equipment consists of the following:

	March 31, 2018		December 31, 2017
Land	$	3,263	$	3,263
Building and improvements		15,771		15,751
Furniture, office and computer equipment		4,633		4,406
Manufacturing equipment		24,603		24,153
Construction in progress		5,227		5,326
		53,497		52,899
Less: accumulated depreciation and amortization		15,011		13,825
Property, plant and equipment, net	$	38,486	$	39,074

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Intangible Assets (Tables)

3 Months Ended

Mar. 31, 2018

Goodwill And Intangible Assets Disclosure [Abstract]

Summary of Balance of Intangible Assets

The following represents the balance of the intangible assets at March 31, 2018:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,696	$	7,804
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,696	$	34,204

The following represents the balance of intangible assets at December 31, 2017:

	Cost		Accumulated Amortization		Net Intangible Assets
Royalties and contract manufacturing relationships	$	15,500	$	7,050	$	8,450
In-process research and development		26,400		—		26,400
Total	$	41,900	$	7,050	$	34,850

Schedule of Future Amortization Expense

As of March 31, 2018, future amortization expense is as follows:

	Amortization
2018		1,937
2019		2,583
2020		2,583
2021		701
Total	$	7,804

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Accrued Expenses and Other Current Liabilities (Tables)

3 Months Ended

Mar. 31, 2018

Payables And Accruals [Abstract]

Summary of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

	March 31,		December 31,
	2018		2017
Clinical trial and related costs	$	367	$	383
Professional and consulting fees		926		1,010
Payroll and related costs		3,247		6,387
Property plant and equipment		6		216
Deferred revenue		818		546
Interest payable		—		802
Other		997		553
	$	6,361	$	9,897

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Long-Term Debt (Tables)

3 Months Ended

Mar. 31, 2018

Debt Disclosure [Abstract]

Schedule of Long-Term Debt Balance

The components of the carrying value of the debt as of March 31, 2018, are detailed below:

Principal balance outstanding	$	60,000
Unamortized deferred issuance costs		(6,088	)
Exit fee accretion		45
Total	$	53,957

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Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2018

Commitments And Contingencies Disclosure [Abstract]

Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements

As of March 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the leases, are as follows:

	Lease payments
2018		411
2019		508
2020		408
2021		362
2022		374
Total	$	2,063

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Capital Structure (Tables)

3 Months Ended

Mar. 31, 2018

Equity [Abstract]

Schedule of Warrants Outstanding to Purchase Shares of Common Stock

As of March 31, 2018, the Company had the following warrants outstanding to purchase shares of the Company’s common stock:

Number of Shares	Exercise Price per Share		Expiration Date
140,000	$	12.00	March 2019
350,000	$	19.46	April 2022
294,928	$	3.28	April 2022
348,664	$	8.60	November 2024

Summary of Fair Value and Assumptions Used for Black-Scholes Option-pricing Model for Liability Classified Warrants

The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for these liability classified warrants.

	March 31, 2018			December 31, 2017
Fair value	$	4,179		$	3,406
Expected dividend yield		—	%		—	%
Expected volatility	74		%	75		%
Risk-free interest rates	2.48		%	2.09		%
Remaining contractual term	4.00 years			4.25 years

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Stock-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2018

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model

The fair value of the options was estimated on the date of grant using a Black-Scholes option pricing model with the following assumptions:

	March 31,
	2018		2017
Range of expected option life	6 years		6 years
Expected volatility	74.01% - 74.60%		84.71%
Risk-free interest rate	2.32 - 2.73%		2.05 - 2.17%
Expected dividend yield		—		—

Summary of Stock Option Activity

The following table summarizes stock option activity during the three months ended March 31, 2018:

	Number of shares			Weighted average exercise price		Weighted average remaining contractual life
Balance, December 31, 2017		3,594,875		$	7.17	7.1 years
Granted		713,226			9.16
Exercised		(14,575	)		4.49
Expired/forfeited/cancelled		(46,805	)		8.51
Balance, March 31, 2018		4,246,721		$	7.50	7.3 years
Vested		2,213,374		$	6.82	5.7 years
Vested and expected to vest		4,246,721		$	7.50	7.3 years

Summary of Restricted Stock Units Activity

The following table summarizes restricted stock units, or RSUs, activity during the three months ended March 31, 2018.

	Number of shares
Balance, December 31, 2017		270,593
Granted		500,120
Vested and settled		(35,025	)
Expired/forfeited/cancelled		(9,366	)
Balance, March 31, 2018		726,322
Expected to vest		726,322

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Segment Reporting (Tables)

3 Months Ended

Mar. 31, 2018

Segment Reporting [Abstract]

Summary of Segment Information

The following table summarizes segment information as of and for the three months ended March 31, 2018:

	For the Three Months Ended March 31,
	2018			2017
Revenues:
CDMO	$	19,542		$	18,742
Acute Care		—			—
Total	$	19,542		$	18,742
Operating income (loss):
CDMO	$	6,566		$	6,199
Acute Care		(19,413	)		(13,501	)
Total	$	(12,847	)	$	(7,302	)
Depreciation and amortization:
CDMO	$	1,819		$	1,837
Acute Care		43			5
Total	$	1,862		$	1,842
Capital expenditures:
CDMO	$	329		$	1,530
Acute Care		1,325			214
Total	$	1,654		$	1,744

	March 31,		December 31,
	2018		2017
Total assets:
CDMO	$	80,300	$	78,136
Acute Care		98,153		108,090
Total	$	178,453	$	186,226

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Revenue Recognition (Tables)

3 Months Ended

Mar. 31, 2018

Schedule of Changes in Contract Assets

The following table presents changes in the Company’s contract assets for the three months ended March 31, 2018:

Contract asset, beginning of year	$	3,755
Change in estimate arising from changes in transaction price		817
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional		(4,572	)
Contract assets recognized		5,508
Contract asset, end of period	$	5,508

Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition

The following table disaggregates revenue by business segment and timing of revenue recognition:

	For the Three Months Ended March 31, 2018
	Point in time		Overtime		Total
CDMO	$	19,413	$	129	$	19,542
Acute Care		—		—		—
Revenue		19,413		129		19,542

ASU 2014-09 [Member]

Impact of Adoption of ASU on Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet

The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09 were as follows:

	Balance at December 31, 2017		Adoption of ASU 2014-09			Balance at January 1, 2018
Contract asset	$	—	$	3,755		$	3,755
Deferred income taxes		18,573		(937	)		17,636
Total shareholders' equity		28,848		(2,818	)		26,030

The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed consolidated balance sheet was as follows:

	For the Three Months Ended March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Revenue	$	17,789		$	1,753		$	19,542
Income tax benefit		2,790			(437	)		2,353
Net loss		(13,771	)		1,316			(12,455	)

	March 31, 2018
	Previous Revenue Standard			Adoption of ASU 2014-09			As Reported
Contract assets	$	—		$	5,508		$	5,508
Deferred income taxes		21,363			(1,374	)		19,989
Total assets		174,319			4,134			178,453
Accumulated deficit		(125,119	)		4,134			(120,985	)
Total shareholders' equity		20,442			4,134			24,576
Total liabilities and shareholders' equity		174,319			4,134			178,453

XML

Background - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2018 Segment
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Entity incorporation date	Nov. 15, 2007
Number of operating divisions	2

XML

Development-Stage Risks and Liquidity - Additional Information (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Business Developments Risks And Uncertainties Liquidity [Abstract]
Accumulated deficit	$ 120,985	$ 111,348

XML

Summary of Significant Accounting Principles - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2018 USD ($) Customer shares
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Goodwill impairment | $	$ 0
Indefinite-lived intangible assets impairment | $	$ 0
Dilutive common stock equivalent | shares	0
Accounts Receivable [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Number of customers | Customer	5
Sales Revenue, Net [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Number of customers | Customer	4
Sales Revenue, Net [Member] | Customer Concentration Risk [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Concentration risk percentage	99.00%
Royalties and Contract Manufacturing Relationships [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Definite-lived intangible asset, useful lives	6 years
Furniture and Office Equipment [Member] | Minimum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	3 years
Furniture and Office Equipment [Member] | Maximum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	10 years
Manufacturing Equipment [Member] | Minimum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	6 years
Manufacturing Equipment [Member] | Maximum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment useful life	ten or more years
Vehicles [Member] | Minimum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	2 years
Vehicles [Member] | Maximum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	5 years
Buildings [Member] | Minimum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	35 years
Buildings [Member] | Maximum [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment estimated useful lives	40 years
Leasehold Improvements [Member]
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Property, plant and equipment useful life	the shorter of the lease term or useful life

XML

Summary of Significant Accounting Principles - Computation of Basic and Diluted Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Basic and Diluted Loss Per Share
Net loss	$ (12,455)	$ (8,087)
Weighted average common shares outstanding, basic and diluted	19,219,257	19,049,416
Net loss per share of common stock, basic and diluted	$ (0.65)	$ (0.42)

XML

Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Options [Member] | Restricted Stock Units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding	4,973,043	3,337,461
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding	1,133,592	784,928

XML

Acquisition of Gainesville Facility and Meloxicam - Additional Information (Detail) - Gainesville [Member] $ / shares in Units, $ in Thousands	Apr. 10, 2015 USD ($) $ / shares shares
Business Acquisition [Line Items]
Business acquisition upfront payment in cash	$ 50,000
Working capital adjustment	4,000
Business acquisition contingent consideration possible milestone payments	$ 125,000
Maximum future net product sales milestone percentage	30.00%
Minimum milestone payments percentage	60.00%
Maximum royalty payment percentage	30.00%
Minimum [Member]
Business Acquisition [Line Items]
Future net product sales milestone percentage	10.00%
Royalty payment percentage	10.00%
Maximum [Member]
Business Acquisition [Line Items]
Future net product sales milestone percentage	12.00%
Royalty payment percentage	12.00%
Regulatory Approval and Net Sales Milestones [Member]
Business Acquisition [Line Items]
Business acquisition contingent consideration possible milestone payments	$ 45,000
Seven Year Warrant [Member]
Business Acquisition [Line Items]
Purchase common stock with warrant issue | shares	350,000
Warrant, exercise price per share | $ / shares	$ 19.46

XML

NMB Related License Agreement - Additional Information (Detail) - Cornell University [Member] - Neuromuscular Blocking Agents License Agreement [Member] - USD ($)	1 Months Ended
	Jun. 30, 2017	Mar. 31, 2018
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Acquired IPR&D	$ 766,000
Upfront payment obligation	350,000
Operational liabilities and acquisition-related costs	$ 416,000
Acquired IPR&D charge expected deductible period for income tax purposes	15 years
U.S [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Regulatory approval and commercialization milestones	$ 5,000,000
European [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Regulatory approval and commercialization milestones	$ 3,000,000
Component of Accrued Expenses and Other Current Liabilities and Other Non-current Liabilities [Member]
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]
Operational liabilities and acquisition-related costs		$ 247,000

XML

Fair Value of Financial Instruments - Classification of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Warrants [Member]
Liabilities:
Fair value of liabilities, recurring basis	$ 4,179	$ 3,406
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member]
Assets:
Fair value of total financial assets, recurring basis	16,149	42,457
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Mutual Funds [Member]
Assets:
Fair value of total financial assets, recurring basis	4,162	38,959
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Cash Equivalents [Member]
Assets:
Fair value of total financial assets, recurring basis	14,151	38,959
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Obligations [Member]
Assets:
Fair value of total financial assets, recurring basis	9,989
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Obligations [Member] | Short-term Investments [Member]
Assets:
Fair value of total financial assets, recurring basis	1,998	3,498
Significant Other Observable Inputs (Level 2) [Member]
Assets:
Fair value of total financial assets, recurring basis	20,963
Significant Other Observable Inputs (Level 2) [Member] | Cash Equivalents [Member]
Assets:
Fair value of total financial assets, recurring basis	17,972
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member]
Assets:
Fair value of total financial assets, recurring basis	17,972
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | Short-term Investments [Member]
Assets:
Fair value of total financial assets, recurring basis	2,991
Significant Unobservable Inputs (Level 3) [Member]
Liabilities:
Fair value of liabilities, recurring basis	89,112	85,819
Significant Unobservable Inputs (Level 3) [Member] | Warrants [Member]
Liabilities:
Fair value of liabilities, recurring basis	4,179	3,406
Significant Unobservable Inputs (Level 3) [Member] | Contingent Consideration [Member]
Liabilities:
Fair value of liabilities, recurring basis	$ 84,933	$ 82,413

XML

Fair Value of Financial Instruments - Reconciliation of Contingent Consideration and Warrants Measured at Fair Value on Recurring Basis Using Unobservable Inputs (Detail) $ in Thousands	3 Months Ended
	Mar. 31, 2018 USD ($)
Warrants [Member]
Fair Value Inputs, Assets, Quantitative Information [Line Items]
Balance at December 31, 2017	$ 3,406
Remeasurement	773
Total at March 31, 2018	4,179
Long-term portion as of March 31, 2018	4,179
Contingent Consideration [Member]
Fair Value Inputs, Assets, Quantitative Information [Line Items]
Balance at December 31, 2017	82,413
Remeasurement	2,520
Total at March 31, 2018	84,933
Current portion as of March 31, 2018	33,957
Long-term portion as of March 31, 2018	$ 50,976

XML

Short-term Investments - Summary of Available-for-sale Securities (Detail) $ in Thousands	Mar. 31, 2018 USD ($)
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	$ 37,112
Gross Unrealized Gain	1
Gross Unrealized Loss	(1)
Estimated Fair Value	37,112
Money Market Mutual Funds [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	4,162
Estimated Fair Value	4,162
U.S. Treasury Obligations [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	11,987
Estimated Fair Value	11,987
Commercial Paper [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	20,963
Gross Unrealized Gain	1
Gross Unrealized Loss	(1)
Estimated Fair Value	$ 20,963

XML

Short-term Investments - Additional Information (Detail) - Investment	3 Months Ended	12 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Schedule of Available-for-sale Securities [Line Items]
Number of investments with unrealized losses position, less than 12 months	2
Minimum [Member]
Schedule of Available-for-sale Securities [Line Items]
Investments maturities period	1 month
Maximum [Member]
Schedule of Available-for-sale Securities [Line Items]
Investments maturities period	4 months
U.S. Treasury Obligations [Member] | Maximum [Member]
Schedule of Available-for-sale Securities [Line Items]
Investments maturities period		2 months
Duration of time, investments in continuous unrealized loss position	6 months

XML

Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Inventory Disclosure [Abstract]
Raw materials	$ 2,645	$ 2,130
Work in process	4,672	3,931
Finished goods	3,551	4,488
Inventory	10,868	10,549
Provision for inventory obsolescence	(840)	(710)
Inventory, net	$ 10,028	$ 9,839

XML

Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 53,497	$ 52,899
Less: accumulated depreciation and amortization	15,011	13,825
Property, plant and equipment, net	38,486	39,074
Land [Member]
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	3,263	3,263
Buildings and Improvements [Member]
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	15,771	15,751
Furniture, Office & Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	4,633	4,406
Manufacturing Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	24,603	24,153
Construction in Progress [Member]
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 5,227	$ 5,326

XML

Property, Plant and Equipment - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Property Plant And Equipment [Abstract]
Depreciation expense	$ 1,216	$ 1,196

XML

Intangible Assets - Summary of Balance of Intangible Assets (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Finite-Lived Intangible Assets [Line Items]
Cost, Total	$ 41,900	$ 41,900
Accumulated Amortization	7,696	7,050
Net Intangible Assets, Total	34,204	34,850
Royalties and Contract Manufacturing Relationships [Member]
Finite-Lived Intangible Assets [Line Items]
Cost, Definite-lived	15,500	15,500
Accumulated Amortization	7,696	7,050
Net Intangible Assets, Definite-lived	7,804	8,450
In-Process Research and Development [Member]
Finite-Lived Intangible Assets [Line Items]
Intangible Assets, Indefinite-lived	$ 26,400	$ 26,400

XML

Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Intangible Assets Net Excluding Goodwill [Abstract]
Amortization expense	$ 646	$ 646

XML

Intangible Assets - Summary of Future Amortization Expense (Detail) - Royalties and Contract Manufacturing Relationships [Member] - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Finite-Lived Intangible Assets [Line Items]
2018	$ 1,937
2019	2,583
2020	2,583
2021	701
Total	$ 7,804	$ 8,450

XML

Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Payables And Accruals [Abstract]
Clinical trial and related costs	$ 367	$ 383
Professional and consulting fees	926	1,010
Payroll and related costs	3,247	6,387
Property plant and equipment	6	216
Deferred revenue	818	546
Interest payable		802
Other	997	553
Total accrued expenses and other current liabilities	$ 6,361	$ 9,897

XML

Long-Term Debt - Additional Information (Detail)			3 Months Ended		12 Months Ended
	Nov. 17, 2017 USD ($) Tranche	Apr. 10, 2015	Mar. 31, 2018 USD ($) $ / shares shares	Mar. 31, 2017 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2017 USD ($)
Debt Instrument [Line Items]
Debt instrument, exit fee			$ 45,000
Principal balance outstanding			60,000,000
Payments of debt transaction fees			261,000
Amortization of debt issuance costs			$ 329,000	$ 158,000
Athyrium Opportunities II Acquisition LP | Seven Year Warrant [Member]
Debt Instrument [Line Items]
Purchase common stock with warrant issue | shares			348,664
Warrant, exercise price per share | $ / shares			$ 8.6043
Warrants, exercisable date			Nov. 17, 2024
Athyrium Credit Agreement [Member]
Debt Instrument [Line Items]
Maximum borrowing capacity	$ 10,000,000
Number of additional tranches | Tranche	2
Debt instrument, maturity date	Nov. 17, 2022
Debt instrument, maturity term	5 years
Term loan interest rate, Description			interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum
Debt instrument, frequency of interest payment			quarterly
Exit fee percentage	1.00%
Debt instrument, exit fee	$ 600,000		$ 600,000
Debt instrument, covenant description			The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis. As of March 31, 2018, the Company was in compliance with the covenants
Principal balance outstanding			$ 60,000,000
Debt issuance costs related to credit agreement			$ 4,439,000
Effective interest rate			15.04%
Payments of debt transaction fees			$ 4,178,000
Athyrium Credit Agreement [Member] | Warrants [Member]
Debt Instrument [Line Items]
Initial warrant fair value			$ 2,143,000
Athyrium Credit Agreement [Member] | Floor [Member]
Debt Instrument [Line Items]
Term loan variable interest rate			1.00%
Athyrium Credit Agreement [Member] | LIBOR [Member]
Debt Instrument [Line Items]
Term loan variable interest rate			9.75%
Athyrium Credit Agreement [Member] | Tranche One Term Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	60,000,000
Athyrium Credit Agreement [Member] | Tranche Two Term Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	20,000,000
Athyrium Credit Agreement [Member] | Tranche Two Term Loan [Member] | Alkermes Plc [Member]
Debt Instrument [Line Items]
Debt instrument, unrestricted cash			$ 20,000,000
Athyrium Credit Agreement [Member] | Tranche Three Term Loan [Member]
Debt Instrument [Line Items]
Debt instrument, face amount	$ 20,000,000
Athyrium Credit Agreement [Member] | Tranche Three Term Loan [Member] | Scenario, Forecast [Member]
Debt Instrument [Line Items]
Debt instrument, net sales					$ 20,000,000
OrbiMed Credit Agreement [Member]
Debt Instrument [Line Items]
Proceeds from issuance of initial term loan			60,000,000
Term loan agreement date		Apr. 10, 2015
Repayments of debt and early termination charges			31,767,000
Repayments of debt Principal balance			27,347,000
Prepayment of debt and debt extinguishment costs			$ 4,420,000
OrbiMed Credit Agreement [Member] | Interest Expense [Member]
Debt Instrument [Line Items]
Loss on early extinguishment of debt						$ 6,772,000

XML

Long-Term Debt - Schedule of Long-Term Debt Balance (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Dec. 31, 2017
Debt Disclosure [Abstract]
Principal balance outstanding	$ 60,000
Unamortized deferred issuance costs	(6,088)
Exit fee accretion	45
Total	$ 53,957	$ 53,598

XML

Commitments and Contingencies - Additional Information (Detail)		1 Months Ended	3 Months Ended
	Jan. 02, 2017	Feb. 28, 2017	Mar. 31, 2018 USD ($)	Mar. 31, 2018 EUR (€)
Purchase Commitment [Member]
Supply Commitment [Line Items]
Purchase commitment non cancelable and cancelable			$ 27,228,000
Dublin [Member]
Supply Commitment [Line Items]
Lease commenced date		Feb. 28, 2017
Lease expiration date		Apr. 16, 2020
Term of contract		3 years
Malvern Consulting Group, Inc. (MCG) [Member] | Pennsylvania [Member]
Supply Commitment [Line Items]
Lease commenced date	Jan. 01, 2017
Lease expiration date	Dec. 31, 2022
Term of contract	6 years
Gainesville Transaction [Member]
Supply Commitment [Line Items]
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones			$ 125,000,000
Maximum future net product sales milestone percentage			30.00%	30.00%
Gainesville Transaction [Member] | Regulatory Approval and Net Sales Milestones [Member]
Supply Commitment [Line Items]
Collaborative arrangements, milestone payments upon achievement of regulatory and sales milestones			$ 45,000,000
Minimum [Member] | Gainesville Transaction [Member]
Supply Commitment [Line Items]
Future net product sales milestone percentage			10.00%	10.00%
Maximum [Member] | Executive Officer [Member]
Supply Commitment [Line Items]
Aggregate annual base salaries of employment agreement			$ 734,000
Maximum [Member] | Gainesville Transaction [Member]
Supply Commitment [Line Items]
Future net product sales milestone percentage			12.00%	12.00%
Dexmedetomidine License Agreement [Member]
Supply Commitment [Line Items]
Contingent milestone payments, maximum			$ 25,257,000	€ 20,500,000
Amount of royalty payments due or payable			$ 0
Dexmedetomidine License Agreement [Member] | Minimum [Member]
Supply Commitment [Line Items]
Percentage of royalty payments			10.00%	10.00%
Dexmedetomidine License Agreement [Member] | Maximum [Member]
Supply Commitment [Line Items]
Percentage of royalty payments			20.00%	20.00%
Fadolmidine License Agreement [Member]
Supply Commitment [Line Items]
Amount of royalty payments due or payable			$ 0
Additional contingent milestones payment			$ 15,031,000	€ 12,200,000
Fadolmidine License Agreement [Member] | Minimum [Member]
Supply Commitment [Line Items]
Percentage of royalty payments			10.00%	10.00%
Fadolmidine License Agreement [Member] | Maximum [Member]
Supply Commitment [Line Items]
Percentage of royalty payments			15.00%	15.00%

XML

Commitments and Contingencies - Schedule of Future Minimum Lease Payments, Excluding Operating Expenses and Tenant Improvements (Detail) $ in Thousands	Mar. 31, 2018 USD ($)
Commitments And Contingencies Disclosure [Abstract]
2018	$ 411
2019	508
2020	408
2021	362
2022	374
Lease payments, Total	$ 2,063

XML

Capital Structure - Additional Information (Detail) - USD ($)								3 Months Ended	12 Months Ended
	Mar. 02, 2018	Dec. 29, 2017	Dec. 16, 2016	Aug. 19, 2016	Jul. 07, 2015	Feb. 02, 2015	Mar. 12, 2014	Mar. 31, 2018	Dec. 31, 2016	Dec. 31, 2017
Schedule Of Capitalization Equity [Line Items]
Common stock, shares authorized								50,000,000		50,000,000
Common stock, par value								$ 0.01		$ 0.01
Common stock issuance								$ 3,802,000
Proceeds from sale of common stock, net of transaction costs								3,514,000
Stock issued at fair value								$ 357,000
Preferred stock, shares authorized								10,000,000		10,000,000
Preferred stock, par value								$ 0.01		$ 0.01
Preferred stock, shares issued								0		0
Preferred stock, shares outstanding								0		0
Warrants, Exercise Price $12.00, Expiring on March 2019 [Member]
Schedule Of Capitalization Equity [Line Items]
Warrants outstanding to purchase shares, Number of Shares								140,000
Warrants, Exercise Price $8.60, Expiring on November 2024 [Member]
Schedule Of Capitalization Equity [Line Items]
Warrants outstanding to purchase shares, Number of Shares								348,664
Warrants, Exercise Price $19.46, Expiring on April 2022 [Member]
Schedule Of Capitalization Equity [Line Items]
Warrants outstanding to purchase shares, Number of Shares								350,000
Warrants, Exercise Price $3.28, Expiring on April 2022 [Member]
Schedule Of Capitalization Equity [Line Items]
Warrants outstanding to purchase shares, Number of Shares								294,928
Cowen and Company, LLC [member]
Schedule Of Capitalization Equity [Line Items]
Common stock, par value		$ 0.01
Common stock issuance, shares								0
Cowen and Company, LLC [member] | Maximum [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance		$ 40,000,000
Aspire Capital [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance, shares	33,040					96,463		350,000	1,143,940
Common stock issuance									$ 7,796
Proceeds from sale of common stock, net of transaction costs								$ 3,514,000
Term of purchase agreement	30 months					24 months
Stock issued at fair value						$ 285,000
Cost incurred in stock issuance						253,000
Aspire Capital [Member] | Maximum [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance	$ 20,000,000					$ 10,000,000
Investor [Member]
Schedule Of Capitalization Equity [Line Items]
Aggregate net proceeds from private placement					$ 14,812,000
Placement agents fee percentage					6.00%
Initial Public Offering (IPO) [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance, shares							4,312,500
Sale of stock, price per share							$ 8.00
Gross proceeds on sale of common stock in initial public offering							$ 34,500,000
Payments on underwriting discounts, commissions and offering costs							4,244,000
Common stock issuance							$ 30,256,000
Private Placement [Member] | Investor [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance, shares					1,379,311
Common stock issuance price					$ 11.60
Underwritten Public Offering [Member]
Schedule Of Capitalization Equity [Line Items]
Common stock issuance, shares			6,670,000	1,986,666
Common stock issuance price			$ 6.00	$ 7.50
Proceeds from sale of common stock, net of transaction costs			$ 36,888,000	$ 13,367,000

XML

Capital Structure - Schedule of Warrants Outstanding to Purchase Shares of Common Stock (Detail)	3 Months Ended
	Mar. 31, 2018 $ / shares shares
Warrants, Exercise Price $12.00, Expiring on March 2019 [Member]
Class Of Warrant Or Right [Line Items]
Warrants outstanding to purchase shares, Number of Shares | shares	140,000
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares	$ 12.00
Warrants outstanding to purchase shares, Expiration Date	2019-03
Warrants, Exercise Price $19.46, Expiring on April 2022 [Member]
Class Of Warrant Or Right [Line Items]
Warrants outstanding to purchase shares, Number of Shares | shares	350,000
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares	$ 19.46
Warrants outstanding to purchase shares, Expiration Date	2022-04
Warrants, Exercise Price $3.28, Expiring on April 2022 [Member]
Class Of Warrant Or Right [Line Items]
Warrants outstanding to purchase shares, Number of Shares | shares	294,928
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares	$ 3.28
Warrants outstanding to purchase shares, Expiration Date	2022-04
Warrants, Exercise Price $8.60, Expiring on November 2024 [Member]
Class Of Warrant Or Right [Line Items]
Warrants outstanding to purchase shares, Number of Shares | shares	348,664
Warrants outstanding to purchase shares, Exercise Price per Share | $ / shares	$ 8.60
Warrants outstanding to purchase shares, Expiration Date	2024-11

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Capital Structure - Summary of Fair Value and Assumptions Used for Black-Scholes Option-pricing Model for Liability Classified Warrants (Detail) - Warrants [Member] - USD ($) $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items]
Fair value	$ 4,179	$ 3,406
Expected volatility	74.00%	75.00%
Risk-free interest rates	2.48%	2.09%
Remaining contractual term	4 years	4 years 3 months

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Comprehensive Loss - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Comprehensive Income Net Of Tax [Abstract]
Total comprehensive loss	$ 12,455,000	$ 8,144,000
Tax effect of other comprehensive loss	$ 0	$ 19,000

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Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		3 Months Ended
	Dec. 31, 2017	Dec. 31, 2016	Mar. 31, 2018	Mar. 31, 2017	May 09, 2018	Jun. 30, 2015	Oct. 31, 2013
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options exercisable period			10 years
Stock options vest period			4 years
Weighted average grant-date fair value of the options awarded to employees			$ 6.08	$ 5.29
Stock-based compensation			$ 1,584	$ 892
Aggregate intrinsic value of vested options			9,522
Aggregate intrinsic value of unvested options			$ 5,746
Stock Options Granted Outside Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of options, Granted			961,750
Time-based RSUs Granted Outside Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of restricted stock units granted			44,500
Performance-based RSUs [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of restricted stock units granted			240,224
Unrecognized compensation expense related to unvested performance RSUs, expected to vest			$ 2,671
Time Based Restricted Stock [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options vest period			4 years
Number of restricted stock units granted			259,896
Unrecognized compensation expense related to unvested options, weighted average period			2 years 7 months 6 days
Stock Options And Time-based RSUs [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized compensation expense related to unvested options and time-based RSUs, expected to vest			$ 14,870
2008 Stock Option Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of stock appreciation rights issued in period			0
Additional number of shares authorized for grant			444,000
Shares available for future grants			174
2013 Equity Incentive Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares available for grant							600,000
A&R Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares available for grant			4,036,737		7,036,737	2,000,000
Percentage of outstanding common stock	5.00%	5.00%
Increase in share per "Evergreen" provision	956,341	619,181
Shares available for future grants			254,420

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Stock-Based Compensation - Fair Value of Options Estimated on Date of Grant Using Black-Scholes Option Pricing Model (Detail)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Range of expected option life	6 years	6 years
Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	74.01%	75.10%
Risk-free interest rate	2.32%	1.87%
Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	74.60%	84.71%
Risk-free interest rate	2.73%	2.27%

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Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Number of shares, beginning balance	3,594,875
Number of shares, Granted	713,226
Number of shares, Exercised	(14,575)
Number of shares, Expired/forfeited/cancelled	(46,805)
Number of shares, ending balance	4,246,721	3,594,875
Number of shares, Vested	2,213,374
Number of shares, Vested and expected to vest	4,246,721
Weighted average exercise price, beginning balance	$ 7.17
Weighted average exercise price, Granted	9.16
Weighted average exercise price, Exercised	4.49
Weighted average exercise price, Expired/forfeited/cancelled	8.51
Weighted average exercise price, ending balance	7.50	$ 7.17
Weighted average exercise price, Vested	6.82
Weighted average exercise price, Vested and expected to vest	$ 7.50
Weighted average remaining contractual life	7 years 3 months 18 days	7 years 1 month 6 days
Weighted average remaining contractual life, Vested	5 years 8 months 12 days
Weighted average remaining contractual life, Vested and expected to vest	7 years 3 months 18 days

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Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units [Member]	3 Months Ended
	Mar. 31, 2018 shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares, beginning balance	270,593
Number of shares, Granted	500,120
Number of shares, Vested and settled	(35,025)
Number of shares, Expired/forfeited/cancelled	(9,366)
Number of shares, ending balance	726,322
Number of shares, Expected to vest	726,322

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Segment Reporting - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2018 USD ($) Segment	Mar. 31, 2017 USD ($)
Segment Reporting Information [Line Items]
Number of business segments | Segment	2
Revenue	$ 19,542,000	$ 18,742,000
Acute Care [Member]
Segment Reporting Information [Line Items]
Revenue	$ 0

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Segment Reporting - Summary of Segment Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Dec. 31, 2017
Segment Reporting Information [Line Items]
Revenue	$ 19,542,000	$ 18,742,000
Operating income (loss)	(12,847,000)	(7,302,000)
Depreciation and amortization	1,862,000	1,842,000
Capital expenditures	1,654,000	1,744,000
Total assets	178,453,000		$ 186,226,000
CDMO [Member]
Segment Reporting Information [Line Items]
Revenue	19,542,000	18,742,000
Operating income (loss)	6,566,000	6,199,000
Depreciation and amortization	1,819,000	1,837,000
Capital expenditures	329,000	1,530,000
Total assets	80,300,000		78,136,000
Acute Care [Member]
Segment Reporting Information [Line Items]
Revenue	0
Operating income (loss)	(19,413,000)	(13,501,000)
Depreciation and amortization	43,000	5,000
Capital expenditures	1,325,000	$ 214,000
Total assets	$ 98,153,000		$ 108,090,000

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Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Jan. 01, 2018	Dec. 31, 2017
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Accumulated deficit	$ (120,985)		$ (111,348)
Contract asset	5,508	$ 3,755	$ 3,755
Contract asset, increase in estimates arising from changes in transaction price	817
ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Contract asset		3,755
ASU 2014-09 [Member] | Adoption of ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Accumulated deficit	4,134	(2,818)
Contract asset	$ 5,508	$ 3,755

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Revenue Recognition - Cumulative Effect Of Changes Made to Consolidated Balance Sheet for Adoption of ASU (Detail) - USD ($) $ in Thousands	Mar. 31, 2018	Jan. 01, 2018	Dec. 31, 2017
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Contract asset	$ 5,508	$ 3,755	$ 3,755
Deferred income taxes	19,989		18,573
Total shareholders' equity	24,576		$ 28,848
ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Contract asset		3,755
Deferred income taxes		17,636
Total shareholders' equity		26,030
Adoption of ASU 2014-09 [Member] | ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Contract asset	5,508	3,755
Deferred income taxes	(1,374)	(937)
Total shareholders' equity	$ 4,134	$ (2,818)

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Revenue Recognition - Impact of Adoption of ASU on Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Jan. 01, 2018	Dec. 31, 2017
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Revenue	$ 19,542
Income tax benefit	2,353	$ 293
Net loss	(12,455)	$ (8,087)
Contract asset	5,508		$ 3,755	$ 3,755
Deferred income taxes	19,989			18,573
Total assets	178,453			186,226
Accumulated deficit	(120,985)			(111,348)
Total shareholders' equity	24,576			28,848
Total liabilities and shareholders' equity	178,453			$ 186,226
ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Contract asset			3,755
Deferred income taxes			17,636
Total shareholders' equity			26,030
Previous Revenue Standard [Member] | ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Revenue	17,789
Income tax benefit	2,790
Net loss	(13,771)
Deferred income taxes	21,363
Total assets	174,319
Accumulated deficit	(125,119)
Total shareholders' equity	20,442
Total liabilities and shareholders' equity	174,319
Adoption of ASU 2014-09 [Member] | ASU 2014-09 [Member]
Revenue Initial Application Period Cumulative Effect Transition [Line Items]
Revenue	1,753
Income tax benefit	(437)
Net loss	1,316
Contract asset	5,508		3,755
Deferred income taxes	(1,374)		(937)
Total assets	4,134
Accumulated deficit	4,134		(2,818)
Total shareholders' equity	4,134		$ (2,818)
Total liabilities and shareholders' equity	$ 4,134

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Revenue Recognition - Schedule of Changes in Contract Assets (Detail) $ in Thousands	3 Months Ended
	Mar. 31, 2018 USD ($)
Revenue From Contract With Customer [Abstract]
Contract asset, beginning of year	$ 3,755
Change in estimate arising from changes in transaction price	817
Reclassification of contract asset to receivables, as the result of rights to consideration becoming unconditional	(4,572)
Contract assets recognized	5,508
Contract asset, end of period	$ 5,508

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Revenue Recognition - Disaggregation of Revenue by Business Segment and Timing of Revenue Recognition (Detail) $ in Thousands	3 Months Ended
	Mar. 31, 2018 USD ($)
Disaggregation Of Revenue [Line Items]
Revenue	$ 19,542
CDMO [Member]
Disaggregation Of Revenue [Line Items]
Revenue	19,542
Point In Time [Member]
Disaggregation Of Revenue [Line Items]
Revenue	19,413
Point In Time [Member] | CDMO [Member]
Disaggregation Of Revenue [Line Items]
Revenue	19,413
Overtime [Member]
Disaggregation Of Revenue [Line Items]
Revenue	129
Overtime [Member] | CDMO [Member]
Disaggregation Of Revenue [Line Items]
Revenue	$ 129

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Related Party Transactions - Additional Information (Detail) - Irish Subsidiary [Member] - Managing Director [Member] - HiTech Health [Member] $ in Thousands	3 Months Ended
	Mar. 31, 2018 USD ($)
Related Party Transaction [Line Items]
Related party transaction expenses	$ 109
Service agreement date	2017-11

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Retirement Plan - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Compensation And Retirement Disclosure [Abstract]
Percentage of company's matching contribution with respect to each participant's contribution	100.00%
Company matching contributions to maximum employees eligible compensation	5.00%
Total company contributions to 401 (k) plan	$ 390	$ 343