10-Q 1 a08-25288_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

x

 

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

 

 

 

For the quarterly period ended September 30, 2008

 

 

 

OR

 

 

 

o

 

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

 

 

 

For the transition period from          to           

 

Commission file number: 001-33753

 

Genoptix, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

33-0840570

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer
Identification No.)

 

2110 Rutherford Road

Carlsbad, CA 92008

(Address of principal executive offices, including zip code)

 

(760) 268-6200

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

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

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer x  (Do not check if a smaller reporting company)

 

Smaller reporting company o

 

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

 

As of October 27, 2008, 16,600,353 shares of the registrant’s common stock, $0.001 par value per share, were outstanding.

 

 

 



Table of Contents

 

GENOPTIX, INC.

QUARTERLY REPORT ON FORM 10-Q

For the Quarterly Period Ended September 30, 2008

 

TABLE OF CONTENTS

 

PART I—FINANCIAL INFORMATION

 

Item 1.

Financial Statements.

3

 

Condensed Consolidated Balance Sheets as of September 30, 2008 (unaudited) and December 31, 2007

3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2008 and 2007 (unaudited)

4

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2008 and 2007 (unaudited)

5

 

Notes to Condensed Consolidated Financial Statements (unaudited)

6

Item 2.

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

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

26

Item 4T.

Controls and Procedures.

27

PART II—OTHER INFORMATION

 

Item 1A.

Risk Factors.

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

46

Item 5.

Other Information.

46

Item 6.

Exhibits.

47

SIGNATURE

 

 

EXHIBIT 3.2

 

 

EXHIBIT 10.1

 

 

EXHIBIT 31.1

 

 

EXHIBIT 31.2

 

 

EXHIBIT 32.1

 

 

 

2



Table of Contents

 

PART I.   FINANCIAL INFORMATION

 

Item 1.           Financial Statements.

 

GENOPTIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par values)

 

 

 

September 30,
2008

 

December 31,
2007

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

21,809

 

$

50,624

 

Short-term securities

 

75,321

 

34,836

 

Accounts receivable, net of allowance for doubtful accounts of $3,263 and $1,594 at September 30, 2008 and December 31, 2007, respectively

 

16,362

 

9,013

 

Deferred tax asset

 

6,380

 

 

Other current assets

 

1,280

 

1,409

 

Total current assets

 

121,152

 

95,882

 

Property and equipment, net

 

9,555

 

1,950

 

Long-term securities

 

3,775

 

 

Deferred tax asset

 

3,668

 

 

Restricted cash

 

360

 

 

Other long-term assets

 

179

 

 

Total assets

 

$

138,689

 

$

97,832

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

7,561

 

$

4,238

 

Accrued compensation

 

4,939

 

2,496

 

Income tax payable

 

2,853

 

74

 

Deferred revenues

 

58

 

95

 

Deferred rent

 

248

 

 

Total current liabilities

 

15,659

 

6,903

 

Deferred rent, net of current portion

 

1,510

 

324

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued and outstanding at September 30, 2008 and December 31, 2007

 

 

 

Common stock, $0.001 par value; 100,000 shares authorized; 16,598 and 16,095 shares issued and outstanding at September 30, 2008 and December 31, 2007, respectively

 

17

 

16

 

Additional paid-in capital

 

138,253

 

132,532

 

Accumulated other comprehensive (loss) income

 

(760

)

53

 

Accumulated deficit

 

(15,990

)

(41,996

)

Total stockholders’ equity

 

121,520

 

90,605

 

Total liabilities and stockholders’ equity

 

$

138,689

 

$

97,832

 

 

See accompanying notes to the condensed consolidated financial statements.

 

3



Table of Contents

 

GENOPTIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

32,087

 

$

16,171

 

$

82,210

 

$

40,770

 

Cost of revenues

 

12,282

 

6,513

 

32,663

 

16,543

 

Gross profit

 

19,805

 

9,658

 

49,547

 

24,227

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Sales and marketing

 

5,098

 

3,127

 

14,529

 

7,869

 

General and administrative

 

5,786

 

2,732

 

16,091

 

6,997

 

Research and development

 

333

 

143

 

1,003

 

463

 

Total operating expenses

 

11,217

 

6,002

 

31,623

 

15,329

 

Income from operations

 

8,588

 

3,656

 

17,924

 

8,898

 

Interest income

 

671

 

118

 

2,279

 

245

 

Interest expense

 

(5

)

(72

)

(5

)

(231

)

Other (loss) income

 

(16

)

(1

)

28

 

41

 

Income before income taxes

 

9,238

 

3,701

 

20,226

 

8,953

 

Income tax (benefit) expense

 

(6,190

)

114

 

(5,780

)

274

 

Net income

 

$

15,428

 

$

3,587

 

$

26,006

 

$

8,679

 

 

 

 

 

 

 

 

 

 

 

Net income per share: (1)(2)

 

 

 

 

 

 

 

 

 

Basic

 

$

0.93

 

$

0.43

 

$

1.59

 

$

0.82

 

Diluted

 

$

0.87

 

$

0.06

 

$

1.48

 

$

0.10

 

 

 

 

 

 

 

 

 

 

 

Shares used to compute net income per share: (1)(2)

 

 

 

 

 

 

 

 

 

Basic

 

16,535

 

239

 

16,336

 

191

 

Diluted

 

17,754

 

1,674

 

17,616

 

1,635

 

 


(1)          As a result of the conversion of the Company’s preferred stock into 11,032 shares of common stock upon completion of the Company’s initial public offering in November 2007, there is a lack of comparability in the basic and diluted net income per share amounts for the periods presented above. For calculations of the pro forma net income per share for the periods presented, see Note 8 in the notes to the condensed consolidated financial statements.

 

(2)          For the three and nine months ended September 30, 2007, the Company had net income of $3,587 and $8,679, respectively, of which $3,485 and $8,522, respectively, was allocated to preferred stockholders for purposes of calculating net income per share pursuant to the terms of the preferred stock, resulting in $102 and $157, respectively, of net income allocable to common stockholders. For an explanation of the method and amounts used in the computation of the per share amounts, see Note 8 in the notes to the condensed consolidated financial statements.

 

See accompanying notes to the condensed consolidated financial statements.

 

4



Table of Contents

 

GENOPTIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

Operating activities:

 

 

 

 

 

Net income

 

$

26,006

 

$

8,679

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

Depreciation

 

878

 

405

 

Stock-based compensation expense

 

5,156

 

390

 

Provision for doubtful accounts

 

2,280

 

1,152

 

Deferred taxes

 

(9,519

)

 

Realized loss on sale of investment

 

66

 

 

Amortization of premium/discount on investments

 

(163

)

 

Excess tax benefits from stock-based compensation awards

 

(118

)

 

Gain on sale of property and equipment

 

(10

)

 

Non-cash interest expense

 

 

57

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(9,629

)

(3,960

)

Other current and long-term assets

 

(50

)

(885

)

Accounts payable and accrued expenses

 

3,075

 

2,399

 

Accrued compensation

 

2,443

 

722

 

Income taxes

 

2,897

 

74

 

Deferred revenues

 

(37

)

(32

)

Deferred rent

 

149

 

52

 

Net cash provided by operating activities

 

23,424

 

9,053

 

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Purchase of property and equipment

 

(6,961

)

(788

)

Proceeds from sales of property and equipment

 

21

 

 

Purchase of investment securities

 

(103,605

)

 

Proceeds from sales and maturities of investment securities

 

58,100

 

 

Restricted cash

 

(360

)

 

Net cash used in investing activities

 

(52,805

)

(788

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Proceeds from issuance of common stock, net

 

1,177

 

50

 

Costs paid in connection with public offerings

 

(764

)

(1,074

)

Excess tax benefits from stock-based compensation awards

 

118

 

 

Proceeds from exercise of warrants

 

35

 

 

Proceeds from issuance of notes payable

 

 

284

 

Principal payments on notes payable

 

 

(1,230

)

Principal payments on capital lease obligations

 

 

(19

)

Net cash provided by (used in) financing activities

 

566

 

(1,989

)

Net (decrease) increase in cash and cash equivalents

 

(28,815

)

6,276

 

Cash and cash equivalents at beginning of period

 

50,624

 

3,865

 

Cash and cash equivalents at end of period

 

$

21,809

 

$

10,141

 

 

 

 

 

 

 

Supplemental information:

 

 

 

 

 

Income taxes paid, net

 

$

842

 

$

 

Interest paid

 

$

5

 

$

174

 

Non-cash investing and financing activities:

 

 

 

 

 

Unrealized loss on investment securities, net

 

$

1,342

 

$

 

Capitalized tenant improvement allowance

 

$

1,285

 

$

 

Accrued purchases of property and equipment

 

$

248

 

$

 

 

See accompanying notes to the condensed consolidated financial statements.

 

5



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

 

1.     Organization and Summary of Significant Accounting Policies

 

Organization

 

Genoptix, Inc., or the Company, was incorporated in Delaware on January 20, 1999. Genoptix, Inc. does business as Genoptix Medical Laboratory. The Company operates as a certified “high complexity” clinical laboratory in accordance with the federal government’s Clinical Laboratory Improvement Amendments of 1988, or CLIA, and is dedicated to the delivery of clinical diagnostic services to community-based hematologist/oncologist physician customers.

 

Basis of Presentation and Principles of Consolidation

 

The Company’s industry is highly regulated. The manner in which licensed physicians can organize to perform and bill for medical services is governed by state laws and regulations. Business corporations, like the Company, often are not permitted to employ physicians to practice medicine or to own corporations that employ physicians to practice medicine or to otherwise exercise control over the medical judgments or decisions of physicians.

 

The Company provides its medical services through Cartesian Medical Group, or Cartesian, an entity that it manages, and it is this entity that employs the physicians who provide medical services on behalf of the Company. The Company has a controlling financial interest in Cartesian and consolidates the results of Cartesian based on the criteria under Emerging Issues Task Force, or EITF, Issue No. 97-2, Physician Practice Management Entities and Certain Other Entities with Contractual Management Agreements. All intercompany accounts have been eliminated in consolidation.

 

The Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with United States of America generally accepted accounting principles, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, all adjustments have been included and represent only normal recurring adjustments considered necessary for a fair presentation. Operating results for the three and nine months ended September 30, 2008 are not necessarily indicative of the results that may be expected for the year ending December 31, 2008. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto for the year ended December 31, 2007 included in the Annual Report on Form 10-K filed by the Company with the Securities and Exchange Commission, or SEC, on February 12, 2008.

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes to the condensed consolidated financial statements. The most significant estimates in the Company’s condensed consolidated financial statements relate to revenue recognition, allowance for doubtful accounts, income taxes and stock-based compensation expense. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company recognizes revenues in accordance with the SEC’s Staff Accounting Bulletin, or SAB, No. 104, Revenue Recognition, when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed and collectibility of the resulting receivable is reasonably assured.

 

The Company’s specialized diagnostic services are performed based on a written test requisition form and revenues are recognized once the diagnostic services have been performed, the results have been delivered to the ordering physician, the payor has been identified and eligibility and insurance have been verified. These diagnostic services are billed to various payors, including Medicare, commercial insurance companies and other directly billed healthcare institutions such as hospitals and individuals. The Company reports revenues from contracted payors, including Medicare, certain insurance companies and certain healthcare institutions, based on the contractual rate, or in the case of Medicare, the published fee schedules. The Company reports revenues from non-contracted payors, including certain insurance companies and individuals, based on the amount expected to be collected. The difference between the amount billed and the amount expected to be collected is recorded as a contractual allowance to arrive at the reported revenues. The expected revenues from non-contracted payors are based on the historical collection experience of each payor or payor group, as appropriate. In each reporting period, the Company reviews its historical collection experience for non-contracted payors and adjusts its expected revenues for current and subsequent periods accordingly. During the three months ended

 

6



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

September 30, 2008, the Company recorded positive changes in prior period accounting estimates to reduce contractual allowances, which increased the Company’s revenues by $2.5 million, of which $1.6 million pertains to the six months ended June 30, 2008. During the nine months ended September 30, 2008, the Company recorded positive changes in prior year accounting estimates to reduce contractual allowances, which increased the Company’s revenue by $2.2 million. In comparison, the Company’s revenues increased by $612,000 and $828,000 for the three and nine months ended September 30, 2007, respectively, as a result of changes in such prior period accounting estimates. These favorable changes in accounting estimates related to non-contracted payors and resulted from continued improvements to the Company’s billing systems and collection processes, as well as increased hiring of personnel and management focused on the collection of accounts receivable for services rendered in prior periods. As of September 30, 2008 and December 31, 2007, the Company had uncollected accounts receivable from non-contracted payors of approximately $9.2 million and $5.3 million, respectively.

 

Allowance for Doubtful Accounts

 

An allowance for doubtful accounts is recorded for estimated uncollectible amounts due from the Company’s contracted payors. The process for estimating the collection of receivables associated with the Company’s specialized diagnostic services involves significant assumptions and judgments. Specifically, the allowance for doubtful accounts is adjusted periodically, based upon an evaluation of historical collection experience with specific payors and other relevant factors. The realization cycle for certain governmental and managed care payors can be lengthy involving denial, appeal and adjudication processes, and is subject to periodic adjustments that may be significant. The provision for doubtful accounts is charged to general and administrative expense. Accounts receivable are written off as uncollectible and deducted from the allowance after appropriate collection efforts have been exhausted.

 

The Company recorded a provision for doubtful accounts at a rate of approximately 3% of revenues for both the three and nine months ended September 30, 2008, which remained consistent with comparable periods in 2007 of approximately 3% of revenue. During the three and nine months ended September 30, 2008, the Company recorded $822,000 and $2.3 million, respectively, of provision for doubtful accounts, as compared to $405,000 and $1.2 million for the comparable periods in 2007. During the three and nine months ended September 30, 2007, the Company recorded positive changes in prior period accounting estimates to reduce the allowance for doubtful accounts by $134,000 and $197,000, respectively. No similar changes in estimates were recorded in the three and nine months ended September 30, 2008. During the nine months ended September 30, 2008, the Company reduced the allowance for doubtful accounts by $611,000 for write-offs, net of recoveries.

 

Reverse Stock Split

 

On October 15, 2007, the Company effected a 1-for-4.75 reverse stock split of the Company’s common stock. The accompanying condensed consolidated financial statements and notes to the condensed consolidated financial statements give retroactive effect to the reverse stock split for prior periods presented.

 

Recent Accounting Pronouncements

 

Effective January 1, 2008, the Company adopted Statement of Financial Accounting Standards, or SFAS, No. 157, Fair Value Measurements. In February 2008, the Financial Accounting Standards Board, or FASB, issued FASB Staff Position, or FSP, No. 157-2, Effective Date of FASB Statement No. 157, which provides a one year deferral of the effective date of SFAS No. 157 for non-financial assets and non-financial liabilities, except those that are recognized or disclosed in the financial statements at fair value at least annually. Therefore, the Company has adopted the provisions of SFAS No. 157 with respect to its financial assets and liabilities only. SFAS No. 157 defines fair value, establishes a framework for measuring fair value under GAAP and enhances disclosures about fair value measurements. Fair value is defined under SFAS No. 157 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. During the third quarter, the Company adopted FSP No. 157-3, Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active. FSP No. 157-3 clarifies the application of SFAS No. 157, in a market that is not active and provides an example to illustrate key considerations in determining the fair value of a financial asset when the market for that financial asset is not active. This FSP applies to financial assets within the scope of accounting pronouncements that require or permit fair value measurements in accordance with SFAS No. 157. The adoption of SFAS No. 157 did not have a material impact on the Company’s condensed consolidated results of operations and financial condition at adoption. For the three and nine months ended September 30, 2008 the Company recorded a temporary impairment of $1.2 million (see Note 2 and Note 3).

 

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Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

Effective January 1, 2008, the Company adopted SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities. SFAS No. 159 allows an entity the irrevocable option to elect fair value for the initial and subsequent measurement for certain financial assets and liabilities on a contract-by-contract basis. The Company did not elect to adopt the fair value option for certain financial instruments on the adoption date.

 

Restricted Cash

 

As of September 30, 2008, the Company had total restricted cash of $360,000. Restricted cash consists of amounts held in a certificate of deposit to collateralize a standby letter of credit per the terms of an operating lease agreement. The standby letter of credit expires on June 30, 2012, allowing for $90,000 annual reductions on June 30 of each year prior to expiration.

 

2.              Investment Securities

 

In accordance with SFAS No. 115, Accounting for Certain Debt and Equity Securities, all of the Company’s investment securities are classified as available-for-sale. Investment securities consist of corporate debt, government-sponsored enterprise and high-grade auction rate securities, or ARS. The Company reports corporate debt securities and government-sponsored enterprise securities as short-term based on its intent to fund current operations and its ability to easily convert the securities into cash. The Company’s ARS are reported as long-term since they are unavailable to fund current operations based on the current illiquid auction market (see Note 3). The investment securities are carried at fair value, with unrealized gains and losses reported as a separate component of accumulated other comprehensive (loss) income. The cost of debt investment securities is adjusted for amortization of premiums and accretion of discounts to maturity. Amortization and accretion are included in interest income. Interest earned and realized gains or losses on available-for-sale investment securities are included in interest income. The cost of investment securities sold is based on the specific identification method.

 

The following is a summary of the Company’s investment securities:

 

 

 

September 30, 
2008

 

December 31, 
2007

 

 

 

(in thousands)

 

Short-term securities

 

 

 

 

 

Corporate debt securities

 

$

35,994

 

$

6,430

 

Government-sponsored enterprise securities

 

39,327

 

11,006

 

Auction rate securities

 

 

17,400

 

 

 

$

75,321

 

$

34,836

 

Long-term securities

 

 

 

 

 

Auction rate securities

 

$

3,775

 

$

 

 

As of September 30, 2008, all of the corporate debt and government-sponsored enterprise investment securities have contractual maturities of less than 19 months and 29 months, respectively.

 

The Company holds a single ARS. ARS are collateralized debt instruments with long-term contractual maturities that are structured with short-term holding periods. The length of each holding period is determined at the original issuance of the ARS. They provide liquidity through a Dutch auction process that resets the applicable interest rate at pre-determined intervals, typically every 7 to 35 days. At the end of each holding period, a new auction is held to determine the rate or dividend for the next holding period. The Company can sell at each auction at par, assuming there are buyers for the ARS at such auction, sell at a discount in a secondary market or continue to hold the investment securities. In order to sell ARS at par, the auction needs to be successful whereby demand in the marketplace meets or exceeds the supply at scheduled auctions. The ARS has a contractual maturity in 2038, with a 35-day holding period between scheduled auctions.

 

Gross unrealized gains of $146,000 and gross unrealized losses of $1.4 million were recorded in accumulated other comprehensive (loss) income, which included a temporary impairment of $1.2 million for ARS at September 30, 2008, as compared to gross unrealized gains of $61,000 and losses of $8,000 at December 31, 2007. Additionally, a gross realized loss of $66,000 was recognized in the condensed consolidated statements of operations for the three months ended September 30, 2008.

 

8



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

3.              Fair Value Measurements

 

Valuation techniques used to measure fair value under SFAS No. 157 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, which may be used to measure fair value, as follows:

 

Level 1

 

Quoted prices in active markets for identical assets or liabilities

 

 

 

Level 2

 

Inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities

 

 

 

Level 3

 

Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities

 

The following table represents the financial instruments on the financial statements of the Company subject to SFAS No.157 and the valuation approach applied to each class:

 

 

 

 

 

Fair Value Measurements at September 30, 2008

 

 

 

Balance at 
September 30,
 2008

 

Quoted Prices 
in Active 
Markets for 
Identical Assets
(Level 1)

 

Significant
Other 
Observable 
Inputs 
(Level 2)

 

Significant 
Unobservable 
Inputs 
(Level 3)

 

 

 

(in thousands)

 

Cash and cash equivalents

 

 

 

 

 

 

 

 

 

Cash

 

$

6,042

 

$

6,042

 

$

 

$

 

Money market funds

 

11,770

 

 

11,770

 

 

Corporate debt securities

 

3,997

 

 

3,997

 

 

 

 

$

21,809

 

$

6,042

 

$

15,767

 

$

 

Short-term securities

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

35,994

 

$

 

$

35,994

 

$

 

Government-sponsored enterprise securities

 

39,327

 

 

39,327

 

 

 

 

$

75,321

 

$

 

$

75,321

 

$

 

Long-term securities

 

 

 

 

 

 

 

 

 

Auction rate securities

 

$

3,775

 

$

 

$

 

$

3,775

 

 

The Company’s corporate debt and government-sponsored enterprise investment securities are valued using market prices on less active markets (level 2). Level 2 valuations are obtained from readily available pricing sources for comparable instruments or other significant and available observable inputs. In contrast, active market (level 1) valuations are obtained from real-time quotes for transactions in active exchange markets involving identical assets and unobservable market (level 3) valuations are required where no quoted market prices or observable inputs are available.

 

The Company’s level 3 ARS consists of debt issued by a municipality, which is underwritten by an insurance agency and rated A2 by Moody’s Investors Service and AA by Standard & Poor’s. It is classified as a long-term investment security due to the current illiquidity in the ARS markets. This auction began failing in February 2008 when sell orders exceeded buy orders at the auction dates. The funds associated with this failed auction will not be accessible until the issuer redeems the ARS, a successful auction occurs, a buyer is found outside of the auction process, or the ARS matures in 2038.

 

9



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

The valuation of this security is based on level 3 unobservable inputs. The Company has evaluated this ARS based on interest rate spreads, the credit quality, underlying assets of the issuer and underwriter, likelihood of a successful auction or redemption in the near term and the ability to obtain liquidity in the near-term. As a result of the estimated fair value, the Company has recorded a temporary impairment in the valuation of this security of $1.2 million during the three months ended September 30, 2008. The unrealized loss in the current period, net of deferred tax, is included in accumulated other comprehensive (loss) income. Due to the uncertainty related to the timing of liquidity in the ARS market, the Company has classified this ARS investment security as a long-term asset on the balance sheet with a fair value of $3.8 million as of September 30, 2008.

 

The following table provides a summary of changes in fair value of the Company’s level 3 financial assets:

 

 

 

Level 3
Auction Rate 
Securities

 

 

 

(in thousands)

 

Balance at December 31, 2007

 

$

 

Transfers into level 3

 

17,400

 

Earned income

 

27

 

Total realized/unrealized losses:

 

 

 

Included in earnings

 

 

Included in accumulated other comprehensive (loss) income

 

(1,252

)

Net purchases and (redemptions)

 

(12,400

)

Balance at September 30, 2008

 

$

3,775

 

Total amount of net unrealized losses for the period included in accumulated other comprehensive (loss) income attributable to the change in fair market value relating to assets still held at September 30, 2008

 

$

(1,225

)

 

4.              Property and Equipment, Net

 

Property and equipment consisted of the following:

 

 

 

Estimated 
Useful Life

 

September 30,
 2008

 

December 31, 
2007

 

 

 

(in years)

 

(in thousands)

 

Machinery and equipment

 

5

 

$

3,104

 

$

1,742

 

Computers

 

3

 

2,784

 

2,021

 

Furniture and fixtures

 

5

 

916

 

519

 

Leasehold improvements

 

Lesser of remaining lease term or 5

 

114

 

52

 

Construction in process

 

 

5,582

 

59

 

Total property and equipment

 

 

 

12,500

 

4,393

 

Accumulated depreciation

 

 

 

(2,945

)

(2,443

)

Total property and equipment, net

 

 

 

$

9,555

 

$

1,950

 

 

The Company leases all of its facilities under operating leases. Some of these lease agreements contain tenant improvement allowances funded by the landlord, rent holidays and rent escalation clauses. GAAP requires rent expense to be recognized on a straight-line basis over the lease term. The difference between the rent due under the stated periods of the leases compared to that

 

10



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

of the straight-line basis is recorded as deferred rent. The Company uses the date that it obtains the legal right to use and control the leased space to begin recording rent expense and amortizing deferred rent on a straight-line basis through the end of the lease.

 

The Company capitalizes tenant improvements related to landlord lease incentives as property and equipment with an offsetting credit to deferred rent. As of September 30, 2008, the Company capitalized $1.3 million of these tenant improvements. Once placed into service, the capitalized tenant improvements will be depreciated over the lesser of the remaining lease term or asset life. The Company is amortizing the lease incentives, recorded as deferred rent, on a straight-line basis over the term of the lease.

 

5.              Comprehensive Income

 

In accordance with SFAS No. 130, Reporting Comprehensive Income, all components of comprehensive income are reported in the financial statements in the period in which they are recognized. Comprehensive income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources.

 

Below is a reconciliation of net income to comprehensive income for the three and nine months ended September 30, 2008 and 2007:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

(in thousands)

 

Net income

 

$

15,428

 

$

3,587

 

$

26,006

 

$

8,679

 

Accumulated other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

Gross unrealized loss on long-term securities

 

(1,217

)

 

(1,342

)

 

Deferred tax

 

529

 

 

529

 

 

 

 

(688

)

 

(813

)

 

Comprehensive income

 

$

14,740

 

$

3,587

 

$

25,193

 

$

8,679

 

 

6.                 Stock-Based Compensation

 

In accordance with SFAS No. 123R, Share-Based Payment, the Company records compensation expense related to share-based transactions, including stock options, shares issued under an employee stock purchase plan, or ESPP, and restricted stock units, or RSUs, which is measured and recognized in the Company’s condensed consolidated financial statements based on fair value. Effective January 1, 2006, the Company adopted SFAS No. 123R using the prospective approach. Under the prospective approach, SFAS No. 123R applies to new awards and to awards modified, repurchased or cancelled after the required effective date. Stock-based compensation expense recognized during the period is based on the value of the portion of awards that is ultimately expected to vest and thus the gross expense is reduced for estimated forfeitures. The Company recognizes stock-based compensation expense over the vesting period using the straight-line method and classifies these amounts in the condensed consolidated statements of operations based on the department to which the recipient reports.

 

During the three and nine months ended September 30, 2008, there were 50,000 and 356,000, respectively, of outstanding stock options exercised, as compared to 20,000 and 124,000 for the comparable periods in 2007.

 

In connection with the Company’s initial public offering, the Company implemented an ESPP on October 29, 2007, which allows qualified employees the opportunity to purchase Company common stock at a discount. Generally, the plan consists of a two-year offering period with four six-month purchase periods and contains a look-back provision for determining the purchase price. The Company values and accounts for its ESPP in accordance with FASB Technical Bulletin, or FTB, No. 97-1, Accounting under Statement 123 for Certain Employee Stock Purchase Plans with a Look-Back Option. The objective of the measurement process for ESPPs with a look-back option is to reasonably measure the fair value of the award at the grant date. The date at which both the Company and employee have a mutual understanding of the terms of the award in exchange for the services already rendered and the employee’s total contributions are known becomes the grant date. At this time, the Company becomes contingently obligated to issue equity instruments to the employee. Typically, the grant date is the first day of each six-month purchase period. The terms of the Company’s initial purchase period varied slightly, as the period extended from October 29, 2007 to June 30, 2008 and allowed for

 

11



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

cash payments in addition to employee payroll deductions. In June 2008, the employee cash payments were received for this first purchase, thereby establishing the grant date for fair value measurement and the recording of the related stock-based compensation expense. On June 30, 2008, upon the closing of the first purchase period, the Company issued approximately 63,000 shares of common stock to employees.

 

Beginning in January 2008, the Company began utilizing RSUs as an additional means to compensate its employees, directors and consultants. The fair value of these granted RSUs is calculated using the intrinsic value method based on the grant date value and is expensed over the life of the award ranging from one to three years. The weighted average grant valuation per award is $29.94 and $29.29 for the three and nine months ended September 30, 2008, respectively. During both the three and nine months ended September 30, 2008, the Company issued 7,000 shares for these awards. There were no awards granted for the comparable periods in 2007. During the three and nine months ended September 30, 2008, the Company recognized $563,000 and $962,000, respectively, of RSUs stock-based compensation expense.

 

The weighted average fair value per share of the employee stock option grants and ESPP shares for the three and nine months ended September 30, 2008 and 2007 was estimated as of the date of grant using a Black-Scholes valuation model with the following weighted average assumptions:

 

 

 

Stock Options

 

ESPP

 

 

 

Three Months Ended 
September 30,

 

Nine Months Ended 
September 30,

 

Three Months 
Ended 
September 30,

 

Nine Months

Ended 
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

2008

 

2008

 

Risk-free interest rate

 

3.27

%

4.54

%

2.92

%

4.69

%

2.38

%

2.83

%

Dividend yield

 

 

 

 

 

 

 

Expected life of awards (years)

 

6.02

 

6.08

 

6.01

 

6.08

 

1.16

 

1.12

 

Volatility

 

48.82

%

56.00

%

51.47

%

58.30

%

37.68

%

37.85

%

Forfeitures

 

7.00

%

7.00

%

7.00

%

7.00

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant date fair value (per share)

 

$

16.79

 

$

10.60

 

$

14.43

 

$

10.80

 

$

11.45

 

$

14.45

 

 

The Company derived the risk-free interest rate assumption from the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. The Company based the assumed dividend yield on its expectation of not paying dividends in the foreseeable future. The Company calculated the weighted average expected life of options using the simplified method as prescribed by SAB No. 110, Share-Based Payment, based on the lack of relevant historical data due to the Company’s limited operating experience as a public company. In addition, due to the Company’s limited historical data, the estimated volatility also reflects the application of SAB No. 110, incorporating the historical volatility of comparable companies with publicly available share prices. SFAS No. 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For stock options, the Company utilized its historical forfeitures to estimate its future forfeiture rate at 7%. For its ESPP, the Company does not utilize a separate forfeiture rate since it adjusts ESPP stock-based compensation to actual contributions from the remaining participants at the end of each respective purchase period.

 

The Company records equity instruments issued to non-employee consultants as expense at their fair value over the related service period as determined in accordance with SFAS No. 123R and EITF Issue No. 96-18, Accounting for Equity Instruments That are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods and Services, and periodically revalues the equity instruments as they vest. During the three and nine months ended September 30, 2008, the Company recognized $14,000 and $38,000, respectively, of non-employee stock-based compensation expense, as compared to $5,000 and $22,000 for the comparable periods in 2007.

 

12



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

The Company recognized stock-based compensation expense, as follows:

 

 

 

Three Months Ended 
September 30, 2008

 

Three Months Ended 
September 30, 2007

 

 

 

Options
& Other
Awards

 

ESPP

 

Total

 

Options 
& Other 
Awards

 

ESPP

 

Total

 

 

 

(in thousands, except per share data)

 

Cost of revenues

 

$

451

 

$

142

 

$

593

 

$

44

 

$

 

$

44

 

Sales and marketing

 

139

 

226

 

365

 

31

 

 

31

 

General and administrative

 

877

 

113

 

990

 

60

 

 

60

 

Research and development

 

 

 

 

16

 

 

16

 

 

 

$

1,467

 

$

481

 

$

1,948

 

$

151

 

$

 

$

151

 

Impact on net income per common share: (1)

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.09

)

$

(0.03

)

$

(0.12

)

 

 

 

 

 

 

Diluted

 

$

(0.08

)

$

(0.03

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

Nine Months Ended 
September 30, 2008

 

Nine Months Ended 
September 30, 2007

 

 

 

Options
& Other 
Awards

 

ESPP

 

Total

 

Options 
& Other 
Awards

 

ESPP

 

Total

 

 

 

(in thousands, except per share data)

 

Cost of revenues

 

$

1,011

 

$

634

 

$

1,645

 

$

95

 

$

 

$

95

 

Sales and marketing

 

317

 

1,169

 

1,486

 

72

 

 

72

 

General and administrative

 

1,479

 

546

 

2,025

 

158

 

 

158

 

Research and development

 

 

 

 

47

 

 

47

 

 

 

$

2,807

 

$

2,349

 

$

5,156

 

$

372

 

$

 

$

372

 

Impact on net income per common share: (1)

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.17

)

$

(0.14

)

$

(0.31

)

 

 

 

 

 

 

Diluted

 

$

(0.16

)

$

(0.13

)

$

(0.29

)

 

 

 

 

 

 

 


(1)          There is a lack of comparability in the basic and diluted net income per share amounts for the periods presented above due to use of the two-class method in the periods prior to the Company’s initial public offering. Therefore, the impact on net income per common share for the three and nine months ended 2007 is not presented. For an explanation of the methods used to calculate net income per share for the periods presented, see Note 8 in these notes to condensed consolidated financial statements.

 

7.            Income Tax (Benefit) Expense

 

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 basis and operating loss and tax credit carryforwards. The Company measures tax assets and liabilities using the enacted tax rates expected to apply to taxable income in the years in which the Company expects to recover or settle those temporary differences. The Company recognizes the effect of a change in tax rates on deferred tax assets and liabilities in income during the period that includes the enactment date. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the net deferred tax assets will be realized.

 

13



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

As of December 31, 2007, the Company had federal and state net operating loss carryforwards of approximately $28.0 million and $27.0 million, respectively. In each period since the Company’s inception, the Company had recorded a valuation allowance for the full amount of the Company’s net deferred tax assets, as the realization of the net deferred tax assets did not meet the “more likely than not” requirement under SFAS No. 109, Accounting for Income Taxes. If not used, the federal and state net operating loss carryforwards will begin expiring in 2020 and 2010, respectively. As of December 31, 2007, the Company had federal research credit carryforwards of $908,000, which will begin expiring in 2021 and state research credit carryforwards of $1.2 million, which do not expire. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, substantial changes in our ownership have required us to limit the amount of net operating loss and research and development credit carryforwards that were previously available to offset future taxable income. The Company has had three “change in ownership” events that limit the utilization of net operating loss and credit carryforwards. The “change in ownership” events occurred in March 2000, December 2001 and March 2008 and resulted in annual net operating loss carryforward limitations of $63,000, $96,000 and $16.1 million, respectively. As a result of a net unrealized built-in gain from the March 2008 change in ownership, the Company’s net operating loss carryforward annual limitation of $16.1 million was increased to $39.7 million for each of the five years starting after the change in ownership. These limitations will result in the expiration of unused federal and state net operating loss carryforwards of $6.6 million and $7.4 million, respectively. Additionally, these limitations will result in the expiration of federal and state tax credits in the amount of $154,000 and $130,000, respectively. The net deferred tax assets were reduced due to the net operating loss and tax credit limitations, with a corresponding reduction of the valuation allowance. Additional limitations on the use of these tax attributes could occur in the event of possible disputes arising in examination from various taxing authorities. Currently, the Company is not under examination by any taxing authorities.

 

As of September 30, 2008, although realization is not assured, the Company believed it was more likely than not that it would be able to realize its net deferred tax assets through the ordinary course of business and expected future taxable income. Therefore, the Company recorded a $9.8 million tax benefit representing the release of the valuation allowance against the net deferred tax assets during the three months ended September 30, 2008. The income tax benefit for the three and nine months ended September 30, 2008 was $6.2 million and $5.8 million, respectively. The income tax expense for the three and nine months ended September 30, 2007 was $114,000 and $274,000, respectively. As of September 30, 2008, the Company had $10.0 million in net deferred tax assets. Similarly, the Company had $14.9 million in net deferred tax assets at December 31, 2007 that were offset entirely by the valuation allowance.

 

The Company’s unrecognized income tax benefits decreased by $428,000 during the three months ended September 30, 2008. The adjustment decrease relates primarily to the recognition of additional uncertain income tax benefits related to its federal and state research credit carryforwards.

 

8.                 Net Income Per Share

 

Prior to the Company’s initial public offering, net income per share was computed in accordance with EITF Issue No. 03-6, Participating Securities and the Two-Class Method under FASB Statement 128, which established standards regarding the computation of earnings per share, or EPS, by companies that have issued securities other than common stock that contractually entitle the holder to participate in dividends and earnings of the Company. EITF Issue No. 03-6 requires earnings for the period, after deduction of preferred stock dividends, to be allocated between the common and preferred stockholders based on their respective rights to receive dividends, whether or not declared. Basic net income per share is then calculated by dividing income allocable to common stockholders (after the reduction for any preferred stock dividends assuming current income for the period had been distributed) by the weighted average number of shares of common stock outstanding, net of shares subject to repurchase by the Company, during the period. EITF Issue No. 03-6 does not require the presentation of basic and diluted net income per share for securities other than common stock; therefore, the following net income per share amounts only pertain to the Company’s common stock. The Company calculated diluted net income per share under the as-if-converted method unless the conversion of the preferred stock was anti-dilutive to basic net income per share. To the extent preferred stock was anti-dilutive, the Company calculated diluted net income per share under the two-class method.

 

14



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

Subsequent to the Company’s initial public offering, EPS has been computed in accordance with SFAS No. 128, Earnings Per Share. Basic EPS has been calculated by dividing the net income by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted EPS has been computed by dividing the net income by the weighted average number of common shares outstanding for the period and the weighted average number of dilutive common stock equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, common stock subject to repurchase by the Company, convertible preferred stock, stock options, RSUs and warrants are considered to be common stock equivalents and are only included in the calculation of diluted earnings per share when their effect is dilutive.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

(in thousands, except per share data)

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income

 

$

15,428

 

$

3,587

 

$

26,006

 

$

8,679

 

Income allocable to preferred stockholders

 

 

(3,485

)

 

(8,522

)

Net income allocable to common stockholders

 

$

15,428

 

$

102

 

$

26,006

 

$

157

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares of common stock outstanding

 

16,568

 

318

 

16,379

 

249

 

Weighted average unvested shares of common stock subject to repurchase

 

(33

)

(79

)

(43

)

(58

)

Weighted average shares of common stock outstanding - basic

 

16,535

 

239

 

16,336

 

191

 

Dilutive effect of common equivalent shares

 

1,219

 

1,435

 

1,280

 

1,444

 

Weighted average shares of common stock outstanding - diluted

 

17,754

 

1,674

 

17,616

 

1,635

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.93

 

$

0.43

 

$

1.59

 

$

0.82

 

Diluted

 

$

0.87

 

$

0.06

 

$

1.48

 

$

0.10

 

 

The following amounts were not included in the calculation of net income per share because their effects were anti-dilutive:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

(in thousands)

 

Preferred stock

 

 

11,032

 

 

11,032

 

Preferred stock warrants

 

 

86

 

 

86

 

Common stock options

 

76

 

 

87

 

 

 

 

76

 

11,118

 

87

 

11,118

 

 

15



Table of Contents

 

GENOPTIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(unaudited)

 

Pro Forma Net Income Per Share

 

Pro forma basic and diluted net income per share have been computed to give effect to the conversion of convertible preferred stock into common stock upon the closing of the Company’s initial public offering on an as-if-converted basis at the later of the beginning of the period or the issuance date, as follows:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

Pro Forma 
2007

 

2008

 

Pro Forma 
2007

 

 

 

(in thousands, except per share data)

 

Numerator:

 

 

 

 

 

 

 

 

 

Pro forma net income allocable to common stockholders

 

$

15,428

 

$

3,587

 

$

26,006

 

$

8,679

 

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares of common stock outstanding

 

16,568

 

318

 

16,379

 

249

 

Weighted average unvested shares of common stock subject to repurchase

 

(33

)

(79

)

(43

)

(58

)

Adjustments to reflect the weighted average effect of the assumed conversion of convertible preferred stock

 

 

11,032

 

 

11,032

 

Pro forma weighted average shares of common stock outstanding - basic

 

16,535

 

11,271

 

16,336

 

11,223

 

Dilutive effect of common equivalent shares

 

1,219

 

1,501

 

1,280

 

1,505

 

Pro forma weighted average shares of common stock outstanding - diluted

 

17,754

 

12,772

 

17,616

 

12,728

 

 

 

 

 

 

 

 

 

 

 

Pro forma net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.93

 

$

0.32

 

$

1.59

 

$

0.77

 

Diluted

 

$

0.87

 

$

0.28

 

$

1.48

 

$

0.68

 

 

16



Table of Contents

 

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

 

The following discussion contains forward-looking statements, which involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q. The interim financial statements and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, and the consolidated financial statements and notes thereto for the year ended December 31, 2007 and our related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K filed by us with the Securities and Exchange Commission, or SEC, on February 12, 2008.  Unless the context indicated otherwise, as used in this Quarterly Report on Form 10-Q, the terms “we,” “us” and “our” refer to Genoptix, Inc.

 

We maintain a website at www.genoptix.com to which we regularly post copies of our press releases as well as additional information about us. Our filings with the SEC are available free of charge through our website as soon as reasonably practicable after being electronically filed with or furnished to the SEC. Interested persons can subscribe on our website to email alerts that are sent automatically when we issue press releases, file our reports with the SEC or certain other information is available. Information contained in our website does not constitute a part of this report.

 

Forward-Looking Statements

 

The information in this discussion and in other items of this Quarterly Report on Form 10-Q contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II,  Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC. We do not assume any obligation to update any forward-looking statements.

 

Overview

 

We are a specialized laboratory service provider focused on delivering personalized and comprehensive diagnostic services to community-based hematologists and oncologists, or hem/oncs. Our highly trained group of hematopathologists, or hempaths, utilizes sophisticated diagnostic technologies to provide a differentiated, specialized and integrated assessment of a patient’s condition, aiding physicians in making vital decisions concerning the treatment of malignancies of the blood and bone marrow and other forms of cancer.

 

We were organized in 1999. We began offering specialized diagnostic services in the third quarter of 2004. Our key service offerings include COMPASS and CHART. By ordering our COMPASS service offering, the hem/onc authorizes our hempath to determine the appropriate diagnostic tests to be performed and we evaluate, synthesize and summarize the results into an easy to read comprehensive report. As part of our CHART service offering, the hem/onc receives a detailed assessment of a patient’s disease progression over time, as our hempath integrates patient history and previous and current test results into a comprehensive diagnostic report. Test requisitions for more than half of the patient samples we processed for the three and nine months ended September 30, 2008 included our COMPASS or CHART service offerings.

 

Revenues primarily consist of payments or reimbursements received from governmental payors, such as Medicare and Medicaid, private insurers, including managed care organizations, private payors, such as hospitals, patients and others for the specialized diagnostic services rendered to our hem/onc customers. Our revenues are affected by changes in customer and case volume, payor mix and reimbursement rates.

 

Billing for diagnostic services is generally a highly complex activity. Depending on our billing arrangement with each third party payor and applicable law, we are often obligated to bill in the specific manner prescribed by the various payors, each of which may have different billing requirements. Billing for diagnostic services in connection with governmental payor programs is subject to numerous federal and state regulations and other requirements, resulting in additional costs to us. We report revenues from contracted

 

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payors, including Medicare, certain insurance companies and certain healthcare institutions, based on the contractual rate, or in the case of Medicare, the published fee schedules. We report revenues from non-contracted payors, including certain insurance companies and individuals, based on the amount expected to be collected. We estimate amounts to be collected based on our historical collection experience.

 

As a specialized diagnostic service provider, we rely extensively on our high quality of service to promote and maintain our relationships with our community-based hem/onc customers. We compete primarily based on the quality of testing, operations processes, reporting and information systems, reliability in patient sample transport, reputation in the medical community and access to our highly qualified hempaths. Our primary competitors include hospital pathologists, esoteric testing laboratories, national reference laboratories and academic laboratories.

 

We believe the key challenges in being able to continue to increase our market share, revenues and profitability are our ability to continue to hire and retain qualified sales representatives, key management and other personnel, Cartesian’s ability to hire and retain hempaths, changes in reimbursement levels for our specialized diagnostic services, changes in regulations, payor policies and contracting arrangements with payors, increased competition from competitors attempting to replicate our key service offerings or provide other services that compete with ours, our ability to scale our internal infrastructure, our ability to maintain and strengthen our relationships with our hem/onc customers and our ability to continue to improve our operational, financial and management controls and reporting systems and procedures.

 

To address these challenges, our management is focused upon expanding our sales organization as the primary driver for our continued growth while maintaining our existing hem/onc customer relationships. Our management tracks and measures the general buying patterns of our hem/onc customers (including cases per month, revenues and cost of revenues per case and turn-around-time per case) and is focused on adding additional sales resources in key markets to enhance our penetration in those markets. Our management is also engaged in ensuring Cartesian is focused on recruiting, hiring and retaining hempaths to provide the professional services component to support continued growth. Management measures the levels and timeliness of reimbursement from third party payors and reviews on a monthly basis the levels of receivables and average time for collections, as well as cost and margin trends to ensure that investments in our infrastructure and personnel are in line with current sales levels.

 

Management has initiated efforts to ensure that office and laboratory space is leased and improved to accommodate the necessary capacity requirements to meet our current and expanding business. Specifically, during the three months ended September 30, 2008, we substantially completed tenant improvements within our existing facility having converted warehouse and adjacent space to laboratory operations. Additionally, during this same period, we initiated tenant improvements on our newly leased office space, which will house our administrative functions. Together, these facility actions will approximately double our overall testing capacity and increase both cost of revenue and administrative expenses relating to the associated lease expense and depreciation of tenant improvements. For the three and nine months ended September 30, 2008, capital expenditures for these two projects totaled $3.8 million and $4.7 million, respectively. We expect to occupy these newly developed spaces by late 2008, and as a result of our newly increased capacity, we currently are not anticipating the need to expand into a new facility located in another region in 2009, as previously contemplated.

 

Seasonality

 

The majority of our testing volume is dependent on patient visits to hem/oncs’ offices and other healthcare providers. Volume of testing generally declines during the vacation seasons, year-end holiday periods and other major holidays, particularly when those holidays fall during the middle of the week. In addition, volume of testing tends to decline due to adverse weather conditions, such as excessively hot or cold spells or hurricanes or tornados in certain regions, consequently reducing revenues and cash flows in any affected period. Therefore, comparison of the results of successive periods may not accurately reflect trends for successive periods.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations are based upon our financial statements, which are prepared in accordance with United States of America generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, related 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. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition, allowance for doubtful accounts, income taxes and stock-based compensation expense. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances.

 

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Materially different results can occur as circumstances change and additional information becomes known.

 

We believe there have been no significant changes during the nine months ended September 30, 2008 to the items that we disclosed as our critical accounting policies and estimates in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2007, except for the items discussed below.

 

We adopted SFAS No. 157, Fair Value Measurements, and SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities, in the current period without material impact to the financial statements. For additional information on the recent accounting pronouncements affecting our business, see Note 1, Note 2 and Note 3 in the Notes to Condensed Consolidated Financial Statements.

 

In accordance with SFAS No. 123R, Share-Based Payment, we recorded compensation expense related to share-based transactions, including stock options, shares issued under our employee stock purchase plan, or ESPP, and restricted stock units, or RSUs, all of which are measured and recognized in our condensed consolidated financial statements based on fair value. Effective January 1, 2006, we adopted SFAS No. 123R using the prospective approach. Under the prospective approach, SFAS No. 123R applies to new awards and to awards modified, repurchased or cancelled after the required effective date. Stock-based compensation expense recognized during the period is based on the value of the portion of awards that is ultimately expected to vest and thus the gross expense is reduced for estimated forfeitures. We recognize stock-based compensation expense over the vesting period using the straight-line method and classify these amounts in the condensed consolidated statements of operations based on the department to which the recipient reports.

 

In connection with our initial public offering, we implemented our ESPP on October 29, 2007, which allows qualified employees the opportunity to purchase our common stock at a discount. Generally, the plan consists of a two-year offering period with four six-month purchase periods and contains a look-back provision for determining the purchase price. The terms of the initial purchase period varied slightly, as the period extended from October 29, 2007 to June 30, 2008 and allowed for cash contributions in addition to employee payroll deductions. We value and account for our ESPP in accordance with FASB Technical Bulletin, or FTB, No. 97-1, Accounting under Statement 123 for Certain Employee Stock Purchase Plans with a Look-Back Option. This technical guidance required the delay of recognition of the associated stock-based compensation expense relating to this initial purchase period until the actual employee participation was known. In June 2008, the employee cash contributions were received and the related stock-based compensation expense was recorded.

 

Results of Operations

 

Comparison of Three and Nine Months Ended September 30, 2008 and 2007

 

Revenues

 

Revenues primarily consist of payments or reimbursements received from governmental payors, such as Medicare and Medicaid, private insurers, including managed care organizations, private payors, such as hospitals, patients and others for the specialized diagnostic services rendered to our hem/onc customers. Substantially all of our revenues result from our having been assigned the right to bill and collect for the professional services provided by the hempaths employed by Cartesian who work with us in our laboratory facility pursuant to our Clinical Laboratory Professional Services Agreement, or PSA, with Cartesian. Our revenues from services not performed by Cartesian were less than 5% of our total revenues during the three and nine months ended September 30, 2008 and 2007.

 

For the three and nine months ended September 30, 2008, we derived approximately 62% and 60%, respectively, of our revenues from private insurance, including managed care organizations and other healthcare insurance providers; approximately 37% and 39%, respectively, from Medicare and Medicaid; and the remaining approximate 1% for each period are from other sources. Our revenues are affected by changes in customer and case volume, payor mix, contractual allowances and reimbursement rates. Billing and reimbursement for our specialized diagnostic services in connection with governmental payor programs are subject to numerous federal and state regulations and other billing requirements. Reimbursement under Medicare for our specialized diagnostic services is subject to a Medicare physician fee schedule, and to a lesser degree, a clinical laboratory fee schedule, both of which are typically updated annually. The Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, includes a provision for a 1.1% conversion factor increase effective January 2009.

 

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Three Months Ended
September 30,

 

%

 

Nine Months Ended
September 30,

 

%

 

 

 

2008

 

2007

 

 Change

 

2008

 

2007

 

 Change

 

Revenue (1) (in thousands)

$

32,087

 

$

16,171

 

98

%

$

82,210

 

$

40,770

 

102

%

Number of cases

9,886

 

6,029

 

64

%

27,048

 

15,717

 

72

%

Revenues per case

$

3,246

 

$

2,682

 

21

%

$

3,039

 

$

2,594

 

17

%

 


(1)

 

During the three months ended September 30, 2008, we recorded positive changes in prior period accounting estimates to reduce contractual allowances, which increased our revenues by $2.5 million, of which $1.6 million pertains to the six months ended June 30, 2008. During the nine months ended September 30, 2008, we recorded positive changes in prior year accounting estimates to reduce contractual allowances, which increased our revenues by $2.2 million. In comparison, our revenues increased by $612,000 and $828,000 for the three and nine months ended September 30, 2007, respectively, as a result of changes in such prior year accounting estimates. These favorable changes in accounting estimates related to non-contracted payors and resulted from continued improvements to our billing systems and collection processes, as well as increased hiring of personnel and management focused on the collection of accounts receivable for services rendered in prior periods.

 

Revenues increased to $32.1 million and $82.2 million for the three and nine months ended September 30, 2008, respectively, (inclusive of the changes in prior period accounting estimates noted above) from $16.2 million and $40.8 million for the comparable periods in 2007. The increases of $15.9 million, or 98%, and $41.4 million, or 102%, for the three and nine months ended September 30, 2008, respectively, as compared to the same periods in 2007, were primarily due to case volume increases of 64% and 72%, respectively; revenue per case increases of $564, or 21%, and $445, or 17%, respectively, as a result of a net increase in Medicare reimbursement rates for our key service offerings; and better than expected collections on our non-contracted business as reflected by the changes in accounting estimates, as discussed above. Case volumes, and therefore revenues, have increased during the three and nine months ended September 30, 2008, primarily as a result of the 63% increase in our sales force from September 30, 2007 to September 30, 2008. This has enabled us to penetrate more accounts over a wider geographic area, increase our customer base and further focus our sales representatives on in-person customer visits. Sales force productivity during the three and nine months ended September 30, 2008 also increased primarily as a result of more efficient selling efforts, enhanced recognition in the market, smaller geographies per sales representative, price increases and expanded service offerings.

 

Cost of Revenues

 

Cost of revenues consists of employee-related costs (such as salaries, fringe benefits and stock-based compensation) of our Cartesian hempaths, licensed technicians, clinical service coordinators, or CSC, and other support personnel, as well as outside laboratory costs, laboratory supplies, logistic costs, depreciation and administrative-related costs allocated to cost of revenues. Our cost of revenues generally increases as our case volumes and revenues increase. We expect that our cost of revenues will continue to increase, as our case volumes and revenues increase; we hire additional hempaths, technicians and support personnel; incur increased outside laboratory costs; and spend more on supplies to support these anticipated increases. Incrementally, we expect to see increasing logistic costs due to higher fuel surcharges and increasing facility costs as we occupy the newly completed laboratory expansion within our current facility and relocate administrative functions to our new headquarters facility in late 2008.

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

%

 

September 30,

 

%

 

 

 

2008

 

2007

 

 Change

 

2008

 

2007

 

 Change

 

Cost of revenues (in thousands)

$

12,282

 

$

6,513

 

89

%

$

32,663

 

$

16,543

 

97

%

Cost of revenues (% of revenues)

38

%

40

%

 

 

40

%

41

%

 

 

Number of cases

9,886

 

6,029

 

64

%

27,048

 

15,717

 

72

%

Cost of revenues per case

$

1,242

 

$

1,080

 

15

%

$

1,208

 

$

1,053

 

15

%

 

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Cost of revenues increased to $12.3 million and $32.7 million for the three and nine months ended September 30, 2008, respectively, from $6.5 million and $16.5 million for the comparable periods in 2007. As a percentage of revenue, cost of revenues for the three and nine months ended September 30, 2008 remained relatively consistent at 38% and 40%, respectively, from 40% and 41% for the comparable periods in 2007. Despite increased stock-based compensation expense and payroll-related expenses associated with the hiring of laboratory personnel and Cartesian physicians, these percentages have remained relatively consistent due to higher revenues and leveraging of our fixed costs. This, in addition to favorable changes in revenue accounting estimates for prior periods, has resulted in gross margins of 62% and 60% for the three and nine months ended September 30, 2008, respectively, from 60% and 59% for the comparable periods in 2007. Stock-based compensation expense for cost of revenues was $593,000 and $1.6 million, or 2% of revenues, for each of the three and nine months ended September 30, 2008, respectively. We expect stock-based compensation expense to remain consistent in future periods as we grant additional awards to existing employees and new hires.

 

Sales and Marketing Expenses

 

Sales and marketing expenses consist primarily of employee-related costs (such as salaries, commissions, fringe benefits, stock-based compensation and related travel costs for our sales personnel in the field) and depreciation and administrative-related costs allocated to sales and marketing expense functions. We expect our sales and marketing expenses to increase as we hire additional sales representatives and managers as part of our growth strategy.

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

%

 

September 30,

 

%

 

 

 

2008

 

2007

 

 Change

 

2008

 

2007

 

Change

 

Sales and marketing (in thousands)

 

$

5,098

 

$

3,127

 

63

%

$

14,529

 

$

7,869

 

85

%

Sales and marketing (% of revenues)

 

16

%

19

%

 

 

18

%

19

%

 

 

 

Sales and marketing expenses increased to $5.1 million and $14.5 million for the three and nine months ended September 30, 2008, respectively, from $3.1 million and $7.9 million for the comparable periods in 2007. The increases of $2.0 million, or 63%, and $6.6 million, or 85%, for the three and nine months ended September 30, 2008, respectively, as compared to the same periods in 2007, were primarily due to incremental increases of $1.7 million and $6.2 million, respectively, for employee-related costs (including salaries, sales commissions, stock-based compensation expense and travel) and other cost increases due to the increased number of sales representatives, sales managers and customer service personnel that we have hired to drive and support our revenue growth. The number of sales representatives (including three regional managers) increased from 32 to 52 from September 30, 2007 to September 30, 2008, respectively. As a percentage of revenues, sales and marketing expenses have decreased to 16% and 18% for the three and nine months ended September 30, 2008, respectively, from 19% for each of the comparable periods in 2007, due to improved efficiencies with expanded territory coverage while fully utilizing the sales account managers. Stock-based compensation expense for sales and marketing was $365,000 and $1.5 million, or 1% and 2% of revenues, for the three and nine months ended September 30, 2008, respectively. We expect stock-based compensation expense to remain consistent in future periods as we grant additional awards to existing employees and new hires.

 

General and Administrative Expenses

 

General and administrative expenses relate to billing, finance, human resources and other administrative functions consisting of employee-related costs (such as salaries, fringe benefits and stock-based compensation), professional services and depreciation and administrative-related costs allocated to general and administrative expenses. In addition, the provision for doubtful accounts is included in general and administrative expenses. We anticipate increases in our general and administrative expenses as we add personnel; continue to comply with the reporting obligations applicable to publicly held companies; incur additional expenses associated with the expansion of our facilities and backup systems; and continue to build our corporate infrastructure to support our anticipated growth. Incrementally, we expect to see increasing facility costs as we relocate our administrative functions to our new headquarters facility in late 2008.

 

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Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

%

 

September 30,

 

%

 

 

 

2008

 

2007 (1)

 

Change

 

2008

 

2007 (1)

 

Change

 

General and administrative (in thousands)

 

$

5,786

 

$

2,732

 

112

%

$

16,091

 

$

6,997

 

130

%

General and administrative (% of revenues)

 

18

%

17

%

 

 

20

%

17

%

 

 

 


(1)

 

During the three and nine months ended September 30, 2007, we recorded positive changes in prior period accounting estimates to reduce the allowance for doubtful accounts, which decreased general and administrative expenses by $134,000 and $197,000, respectively. These positive changes in accounting estimates were the result of continued improvements to our billing systems and collection processes, as well as favorable experience in the collection of accounts receivable for services rendered in prior periods.

 

General and administrative expenses increased to $5.8 million and $16.1 million for the three and nine months ended September 30, 2008, respectively, from $2.7 million and $7.0 million for the comparable periods in 2007 (inclusive of the changes in prior period accounting estimates noted above). The increases of $3.1 million, or 112%, and $9.1 million, or 130%, for the three and nine months ended September 30, 2008, respectively, as compared to the same periods in 2007, were primarily due to incremental increases of $2.0 million and $5.0 million, respectively, for employee-related costs (including salaries, bonuses, stock-based compensation expense and travel), $554,000 and $1.8 million, respectively, for legal, insurance and consulting costs, and $418,000 and $1.1 million, respectively, for increased provision for doubtful accounts. Employee-related costs increased as a result of the total general and administrative headcount increasing 74% from 34 to 59 from September 30, 2007 to September 30, 2008, respectively, in support of operating as a public company and overall company growth. In addition, we have expanded our infrastructure by enhancing our information systems and implementing finance initiatives to improve billing and support our finance team in complying with added public company reporting obligations. Legal and consulting expenses increased as a result of regulatory initiatives, additional public company obligations and the ongoing development and maintenance of our compliance programs. As a percentage of revenues, general and administrative expenses have increased due to employee-related costs associated with additional headcount and increased incentives such as bonuses, profit-sharing and stock-based compensation expense, as well as provision for doubtful accounts and increased public company costs. Stock-based compensation expense for general and administrative was $990,000 and $2.0 million, or 3% and 2% of revenues, for the three and nine months ended September 30, 2008, respectively. We expect stock-based compensation expense to remain consistent in future periods as we grant additional awards to directors, existing employees and new hires.

 

Research and Development Expenses

 

Research and development expenses primarily consist of compensation, fringe benefits, depreciation, supplies and administrative-related costs allocated to research and development expenses. Our research and development activities primarily relate to the development and validation of diagnostic tests in connection with our specialized diagnostic services.

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

%

 

September 30,

 

%

 

 

 

2008

 

2007

 

Change

 

2008

 

2007

 

Change

 

Research and development (in thousands)

 

$

333

 

$

143

 

133

%

$

1,003

 

$

463

 

117

%

Research and development (% of revenues)

 

1

%

1

%

 

 

1

%

1

%

 

 

 

For the three and nine months ended September 30, 2008, research and development expenses increased to $333,000 and $1.0 million, respectively, from $143,000 and $463,000 for the comparable periods in 2007. The increases of $190,000, or 133%, and $540,000, or 117%, for the three and nine months ended September 30, 2008, respectively, as compared to the same periods in 2007,

 

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were primarily due to costs associated with in-house validation of diagnostic tests. As a percentage of revenues, research and development expenses have remained constant.

 

Interest Income, Interest Expense and Other Income

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

%

 

September 30,

 

%

 

 

 

2008

 

2007

 

Change

 

2008

 

2007

 

Change

 

 

 

(in thousands)

 

 

 

(in thousands)

 

 

 

Interest income

 

$

671

 

$

118

 

469

%

$

2,279

 

$

245

 

830

%

Interest expense

 

$

(5

)

$

(72

)

-93

%

$

(5

)

$

(231

)

-98

%

Other income

 

$

(16

)

$

(1

)

1500

%

$

28

 

$

41

 

-32

%

 

Interest income for the three and nine months ended September 30, 2008 increased primarily due to increased cash and cash equivalents and investment securities from our initial public offering proceeds and cash provided by operations. Our one remaining auction rate security, or ARS, had a cost basis of $5.0 million that has reset to progressively higher rates of return due to failed Dutch auctions. Despite the higher return associated with the failed ARS auction, we have had and will continue to expect lower returns on other investments due to current market conditions. We intend to continue to manage our investments to minimize the overall risk and maximize our returns.

 

Interest expense for the three and nine months ended September 30, 2008 was $5,000 for each period, as compared to $72,000 and $231,000 for comparable periods in 2007. This decrease in interest expense is a result of our repayment of borrowings during the three months ended December 31, 2007, in connection with our initial public offering.

 

Income Tax (Benefit) Expense

 

The income tax benefit for the three and nine months ended September 30, 2008 was $6.2 million and $5.8 million, respectively. The income tax expense for the three and nine months ended September 30, 2007 was $114,000 and $274,000, respectively. The income tax benefit was driven primarily by the release of a $9.8 million valuation allowance offsetting our net deferred tax assets during the three months ended September 30, 2008. Our projected taxable income for 2008 should utilize the available federal net operating losses with any remaining deferred tax assets to be utilized in subsequent years. Although realization is not assured, we believe it is more likely than not that we will be able to realize our net deferred tax assets through the ordinary course of business and expected future taxable income. As of September 30, 2008, we had $10.0 million in net deferred tax assets. Similarly, we had $14.9 million in net deferred tax assets at December 31, 2007, which was offset entirely by our valuation allowance. Due to our sustained profitability, our future effective tax rate will be approximately 45%. This rate is subject to the impact of nondeductible stock-based compensation expense in excess of any tax deductions from disqualifying dispositions.

 

As of December 31, 2007, we had federal and state net operating loss carryforwards of approximately $28.0 million and $27.0 million, respectively. In each period since our inception, we had recorded a valuation allowance for the full amount of our net deferred tax assets, as the realization of the net deferred tax assets did not meet the “more likely than not” requirement under SFAS No. 109, Accounting for Income Taxes. If not used, the federal and state net operating loss carryforwards will begin expiring in 2020 and 2010, respectively. As of December 31, 2007, we had federal research credit carryforwards of $908,000, which will begin expiring in 2021and state research credit carryforwards of $1.2 million, which do not expire. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, substantial changes in our ownership have required us to limit the amount of net operating loss and research and development credit carryforwards that were previously available to offset future taxable income. We have had three “change in ownership” events that limit the utilization of net operating loss and credit carryforwards. The “change in ownership” events occurred in March 2000, December 2001 and March 2008 and result in annual net operating loss carryforward limitations of $63,000, $96,000 and $16.1 million, respectively. As a result of a net unrealized built-in gain from the March 2008 change in ownership, our net operating loss carryforward annual limitation of $16.1 million was increased to $39.7 million for each of the five years starting after the change in ownership. These limitations will result in the expiration of unused federal and state net operating loss carryforwards of $6.6 million and $7.4 million, respectively. Additionally, these limitations will result in the expiration of federal and state tax credits in the amount of $154,000 and $130,000, respectively. The net deferred tax assets were reduced due to the net operating loss and income tax credit limitations, with a corresponding reduction of the valuation allowance. Additional limitations on the use of these income tax attributes could occur in the event of possible disputes arising in examination from various taxing authorities. Currently, we are not under examination by any taxing authorities.

 

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Liquidity and Capital Resources

 

As of September 30, 2008, we had $97.1 million in cash, cash equivalents and short-term investment securities, primarily consisting of money market funds, corporate debt investment securities and government-sponsored enterprise investment securities. We have established guidelines relating to diversification and maturities of our investment securities to preserve principal and maintain liquidity.

 

As of September 30, 2008, we held an ARS with a cost basis of $5.0 million consisting of debt issued by a municipality, which is underwritten by an insurance agency and rated A2 by Moody’s Investors Service and AA by Standard & Poor’s. It is classified as a long-term investment security due to the current illiquidity in the ARS markets. Liquidity is obtained through a Dutch auction at pre-determined intervals, or every 35 days. The recent conditions in the global credit markets have prevented some investors from liquidating their holdings of ARS because the amount of securities submitted for sale has exceeded the amount of purchase orders for such securities. If there is insufficient demand for the securities at the time of an auction, the auction may not be completed and the interest rates may be reset to predetermined higher rates.

 

This auction began failing in February 2008 when sell orders exceeded buy orders at the auction dates. When auctions for this ARS failed, the investment was not readily convertible to cash. The funds associated with this failed auction will not be accessible without loss of principal until the issuer redeems the ARS, a successful auction occurs, a buyer is found outside of the auction process, or the ARS matures in 2038. As such, we may be required to hold it to maturity. Likewise, if the credit ratings of the security issuers deteriorate and any decline in market value is determined to be other-than-temporary, we would be required to adjust the carrying value of the investment through an other-than-temporary impairment charge to the condensed consolidated statement of operations.

 

The valuation of this security is based on an internally developed valuation analysis of interest rate spreads, the credit quality, underlying assets of the issuer and underwriter, likelihood of a successful auction or redemption in the near term and the ability to obtain liquidity in the near-term. As a result of the estimated fair value, we have recorded a temporary impairment in the valuation of this security of $1.2 million during the three months ended September 30, 2008. The unrealized loss in the current period, net of deferred taxes, is included in accumulated other comprehensive (loss) income. Due to the uncertainty related to the timing of liquidity in the ARS market, we have classified this ARS investment security as a long-term asset on our balance sheet with a fair value of $3.8 million as of September 30, 2008. Because we were required to value this security using only subjective inputs, our valuations determined at a later date or by a third party, may be different from the fair values we have determined as of September 30, 2008.

 

We do not currently need to access these funds for operational purposes for the foreseeable future. Based on our ability to access our cash and cash equivalents and short-term investment securities and our expected operating cash flows, we do not anticipate that the temporary illiquidity of this investment will affect our ability to execute our current business plan.

 

As of September 30, 2008, the Company had total restricted cash of $360,000. Restricted cash consists of amounts held in a certificate of deposit to collateralize a standby letter of credit per the terms of an operating lease agreement. The standby letter of credit expires on June 30, 2012, allowing for $90,000 annual reductions on June 30 of each year prior to expiration.

 

Our primary ongoing source of cash is cash receipts on accounts receivable from our revenues. Aside from the growth in revenues, net cash collections of accounts receivable are impacted by the efficiency of our cash collections process as measured by the change in days sales outstanding, or DSO. DSO can vary from period to period depending on the payment cycles and the mix of our payors. Our DSO averaged 53 and 56 days in the three and nine months ended September 30, 2008, respectively, compared to 52 and 61 days for the comparable periods in 2007. As of September 30, 2008, our DSO was 56 days.

 

Our primary uses of cash are to fund operating expenses and the acquisition of property and equipment. Cash used to fund operating expenses excludes the impact of non-cash items such as the provision for doubtful accounts, depreciation and stock-based compensation expense and is impacted by the timing of payments as reflected in the change in our outstanding accounts payable and accrued expenses. Cash used to fund increased headcount includes salary and related employee benefit expenses. Acquisitions of property and equipment primarily consist of purchases of facility improvements, laboratory equipment and computer hardware and software.

 

Over the next 12 to 18 months, we estimate the costs associated with increasing our personnel to be approximately $20.0 to $25.0 million; the costs associated with the expansion of our existing laboratory and administrative facilities and establishing other new laboratory facilities to be approximately $10.0 to $15.0 million; and the costs associated with additional capital expenditures to be approximately $10.0 to $15.0 million. We believe our current cash and cash equivalents and investment securities will be adequate to fund our planned growth and operating activities through at least the next 24 months.

 

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Regardless, we may be required to raise additional funds through public or private equity offerings or debt financings. We do not know if we will be able to obtain additional financing on favorable terms, if at all (particularly in light of the difficult current financial environment and weak economic conditions). If we cannot raise funds on acceptable terms, if and when needed, we may not be able to maintain or grow our business at the rate that we currently anticipate and we may not be able to respond to competitive pressures or unanticipated capital requirements, or we may be required to reduce operating expenses, which would significantly harm our business, financial condition and results of operations.

 

Our future capital uses and requirements depend on numerous factors. These factors include but are not limited to the following:

 

·                  the current economy and financial markets;

 

·                  changes in regulations or payor policies, including reimbursement levels from governmental payors and private insurers, or contracting arrangements with payors or changes in other laws, regulations or policies; and

 

·                  the extent to which we expand our operations and increase our market share.

 

Below is a summary of our cash flows provided by (used in) operating, investing and financing activities for the nine months ended September 30, 2008 and 2007:

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

 

 

(in thousands)

 

Net cash provided by operating activities

 

$

23,424

 

$

9,053

 

Net cash used in investing activities

 

(52,805

)

(788

)

Net cash provided by (used in) financing activities

 

566

 

(1,989

)

Net (decrease) increase in cash and cash equivalents

 

$

(28,815

)

$

6,276

 

 

Operating Activities

 

Net cash provided by operating activities during the nine months ended September 30, 2008 and 2007 was $23.4 million and $9.1 million, respectively. The net incremental increase of $14.4 million, or 159%, was primarily due to incremental increases of $17.3 million in net income due primarily to increased revenues, an additional $4.8 million of non-cash stock-based compensation expense, an increased provision for doubtful accounts of $1.1 million, an additional increase of $2.4 million in accounts payable, accrued expenses and accrued compensation due to timing of payouts, an increase of $2.8 million in income tax payable primarily due to a recent California law temporarily suspending the use of net operating loss benefits resulting in retroactive California state income tax payable since January 1, 2008; offset by a $9.5 million change in deferred taxes primarily due to the release of our valuation allowance against our net deferred tax assets and $5.7 million of incremental increases to accounts receivable as a result of increased revenues.

 

Investing Activities

 

Net cash used in investing activities during the nine months ended September 30, 2008 and 2007 was $52.8 million and $788,000, respectively. The net incremental increase of $52.0 million in cash used in investing activities primarily pertains to $45.5 million of net purchases of short-term and long-term investment securities. This increased activity pertains to short-term and long-term investment securities purchased and sold with proceeds from our initial public offering and cash generated from operations. Additionally, we had increased capital expenditures of $6.2 million pertaining to tenant improvements for expansion of our current facility and our new corporate offices and purchases of laboratory equipment, computers, software and furniture in support of our headcount growth across all functional areas and facility expansion.

 

Financing Activities

 

Net cash provided by financing activities during the nine months ended September 30, 2008 of $566,000 pertains to $1.2 million of net proceeds from the exercise of stock options and warrants, including the purchase by employees of approximately 63,000 shares under the ESPP and $118,000 excess tax benefits related to disqualifying dispositions on stock-based compensation awards, offset by payments of $764,000 for expenses associated with our public offerings. Net cash used in financing activities during the nine months ended September 30, 2007 of $2.0 million pertains to the principal payments on long-term financing and capital leases of $1.2 million and costs paid in connection with our public offerings $1.1 million; offset by notes payable issuances of $284,000 and proceeds from the exercise of stock options of $50,000.

 

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Contractual Obligations and Commitments

 

There have been no material changes, outside of the ordinary course of business, in our outstanding contractual obligations from those disclosed within “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, as contained in our Annual Report on Form 10-K filed by us with the SEC on February 12, 2008, except as noted below.

 

In February 2008, we entered into a two-year lease (with three one-year extension options) for additional office space in Carlsbad, California to house our expanding billing and customer service departments. The noncancelable future minimum payments under the lease total $293,000, $361,000 and $30,000 for the years ending December 31, 2008, 2009 and 2010, respectively. In connection with the April 2008 lease noted below, the February 2008 lease was terminated in August 2008. As such, the 2008 payments under this contract have been transferred and will increase the noncancelable future minimum lease payments under the April 2008 lease. In addition, the 2009 and 2010 future minimum payments of $361,000 and $30,000, respectively, were cancelled.

 

In April 2008, we entered into a six-year operating lease beginning January 1, 2009 for additional office space in Carlsbad, California to relocate and house our future administration offices commencing as of the date of substantial completion of improvements, estimated to occur in late 2008. Our billing and customer service departments relocated to this facility in August 2008 at the time of the lease termination discussed above. The lease contains one five-year extension option and is subject to annual rent increases. In September 2008, we amended the lease to include an additional suite in the building to house our human resources department. Our existing building will be fully dedicated to clinical laboratory applications when the administration functions are moved in late 2008 to our new headquarters facility. The amended noncancelable future minimum payments under the lease total approximately $73,000, $1.5 million, $1.5 million, $1.6 million, $1.6 million and $3.4 million in 2008, 2009, 2010, 2011, 2012 and thereafter, respectively.

 

From time to time, we may enter into contracts with suppliers, manufacturers and other third parties under which we may be required to make payments. Our disclosures do not reflect any future obligations that may arise in the event that we establish additional facilities to house our operations.

 

Off-Balance Sheet Arrangements

 

We have not engaged and do not expect to engage in any off-balance sheet activities.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Market risk represents the risk of loss that may impact our financial position, results of operations or cash flows due to adverse changes in financial and commodity market prices and rates. We are exposed to market risk primarily in the area of changes in United States interest rates and conditions in the credit markets. We do not have any material foreign currency or other derivative financial instruments. Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We attempt to increase the safety and preservation of our invested principal funds by limiting default risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade securities.

 

All of our investment securities are classified as available-for-sale and therefore reported on the balance sheet at market value. Our investment securities consist of corporate debt securities, government-sponsored enterprise securities and ARS.

 

As of September 30, 2008, we held an ARS with a cost basis of $5.0 million consisting of debt issued by a municipality, which is underwritten by an insurance agency and rated A2 by Moody’s Investors Service and AA by Standard & Poor’s. It is classified as a long-term investment security due to the current illiquidity in the ARS markets. Liquidity is obtained through a Dutch auction at pre-determined intervals, or every 35 days. The recent conditions in the global credit markets have prevented some investors from liquidating their holdings of ARS because the amount of securities submitted for sale has exceeded the amount of purchase orders for such securities. If there is insufficient demand for the securities at the time of an auction, the auction may not be completed and the interest rates may be reset to predetermined higher rates.

 

This auction began failing in February 2008 when sell orders exceeded buy orders at the auction dates. When auctions for this ARS failed, the investment was not readily convertible to cash. The funds associated with this failed auction will not be accessible without loss of principal until the issuer redeems the ARS, a successful auction occurs, a buyer is found outside of the auction process,

 

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or the ARS matures in 2038. As such, we may be required to hold it to maturity. Likewise, if the credit ratings of the security issuers deteriorate and any decline in market value is determined to be other-than-temporary, we would be required to adjust the carrying value of the investment through an other-than-temporary impairment charge to the condensed consolidated statement of operations.

 

The valuation of this security is based on an internally developed valuation analysis of interest rate spreads, the credit quality, underlying assets of the issuer and underwriter, likelihood of a successful auction or redemption in the near term and the ability to obtain liquidity in the near-term. As a result of the estimated fair value, we have recorded a temporary impairment in the valuation of this security of $1.2 million during the three months ended September 30, 2008. The unrealized loss in the current period, net of deferred tax, is included in accumulated other comprehensive (loss) income. Due to the uncertainty related to the timing of liquidity in the ARS market, we have classified this ARS investment security as a long-term asset on our balance sheet with a fair value of $3.8 million as of September 30, 2008. Because we were required to value this security using only subjective inputs, our valuations determined at a later date or by a third party, may be different from the fair values we have determined as of September 30, 2008.

 

We do not currently need to access these funds for operational purposes for the foreseeable future. Based on our ability to access our cash and cash equivalents and short-term investment securities and our expected operating cash flows, we do not anticipate that the temporary illiquidity of this investment will affect our ability to execute our current business plan.

 

Item 4T. Controls and Procedures.

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic reports filed with the SEC 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 chief executive officer and chief financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and no evaluation of controls and procedures can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended, or Exchange Act, prior to the filing of this report we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this report. Based on their evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.

 

In addition, management, including our chief executive officer and chief financial officer, did not identify any change in our internal control over financial reporting that occurred during our latest 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 1A. Risk Factors.

 

You should consider carefully the following information about the risks described below, together with the other information contained in this Quarterly Report on Form 10-Q and in our other public filings in evaluating our business. We have marked with an asterisk (*) those risk factors that reflect substantive changes from the risk factors included in our Annual Report on Form 10-K that we filed with the Securities and Exchange Commission, or SEC, on February 12, 2008. If any of the following risks actually occurs, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock would likely decline.

 

Risks Relating to Our Business Operations

 

*                 Reimbursement levels for our specialized diagnostic services are subject to continuing change and any reductions in reimbursement levels would decrease our revenues and adversely affect our results of operations and financial condition.

 

Reimbursement to healthcare providers, such as specialized diagnostic service providers like us, is subject to continuing change in policies by governmental payors, such as Medicare and Medicaid, private insurers, including managed care organizations and other private payors, such as hospitals and private medical groups. Reimbursement from governmental payors is subject to statutory and regulatory changes, retroactive rate adjustments and administrative rulings and other policy changes, all of which could materially decrease the range of services for which we are reimbursed or the reimbursement rates we are paid. For example, the consumer price index, or CPI, update of the clinical laboratory fee schedule for 2004 through 2008 was frozen by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, or MMA. Although this modification to Medicare’s reimbursement rates did not materially affect the amount paid by Medicare for our current services, future modifications to Medicare’s reimbursement rates or the reimbursement rates from other governmental payors could significantly reduce the amounts we receive for the services we provide. Payment rates also may be impacted given that, as of January 1, 2010, we will no longer be able to submit claims to Medicare for our pathology services for hospital patients, but instead will be required to bill hospitals directly for services rendered.

 

Reductions in Medicare’s reimbursement rates for pathology services, for which we currently are paid under the Medicare physician fee schedule, would reduce the amount we receive for a substantial number of our specialized diagnostic tests. The Medicare physician fee schedule is typically updated annually and CMS, the agency responsible for administering the Medicare program, has made a number of methodological changes to components of the formula used to calculate the payment rate. Although, these methodological changes in the past have resulted in significant reductions in the reimbursement for the pathology services we provide, Congressional action has consistently overridden such reductions and provided increases to the fee schedule on an annual basis. For example, for the 2008 annual period, the fee schedule methodology would have reduced Medicare payments for many of the services we provide by approximately 10%. However, effective January 1, 2008, as a result of the Medicare, Medicaid and SCHIP Extension Act of 2007, the conversion factor was increased by 0.5% for payment of claims with dates of service from January 1, 2008 through June 30, 2008. On July 15, 2008, Congress overrode a Presidential veto to pass the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, which extended the 0.5% conversion factor increase for the remainder of 2008, followed by a 1.1% increase effective January 2009. Nevertheless, future Congressional action cannot be assured (particularly in light of the elections in November 2008) and future methodological changes may result in reductions or increases to the Medicare physician fee schedule.

 

The Medicare Modernization Act of 2003 mandated creation of Medicare Administrative Contractors, or MACs, replacing the current system of fiscal intermediaries who oversee fee-for-service claims for the Medicare Part A and Part B programs. In November 2007, CMS awarded the MAC Jurisdiction 1 (California, Hawaii, Nevada, American Samoa, Guam and the Northern Mariana Islands) to Palmetto GBA. The full transition to Palmetto GBA has occurred effective September 2, 2008. The MAC stated methodology for consolidation and transition of Local Coverage Determinations, or LCD, was based on the principal of “least restrictive.” New LCD’s related to our specialized diagnostic services were introduced as a result of the consolidation process. This policy change may result in reductions to, delays in or denials for reimbursement for the services offered. Additionally, the transition from a fiscal intermediary to a MAC is in a very early stage and may result in delays in reimbursement that could have an impact on us and our results of operations.

 

Other policy changes may include competitive bidding by clinical laboratories for the provision of services to the Medicare program, which was the subject of a CMS demonstration project in Carlsbad, California, pursuant to the requirements of the MMA. The implementation of the demonstration project was delayed due to a federal preliminary injunction and the MIPPA subsequently

 

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repealed the competitive bidding demonstration project. If later implemented, competitive bidding could decrease our reimbursement rates for clinical laboratory tests.

 

In addition, some private insurers and other third party payors link their rates to Medicare’s reimbursement rates and a reduction in Medicare reimbursement rates for clinical laboratory and pathology services could result in a corresponding reduction in the reimbursements we receive from such third party payors. Any reductions in reimbursement levels for our specialized diagnostic services would decrease our revenues and adversely affect our results of operations and financial condition.

 

*                 Operating as a non-contracting provider with certain payors may adversely affect our results of operations and financial condition and contracting with those payors may be disadvantageous to us.

 

We are currently considered a “non-contracting provider” by a number of third party payors because we have not entered into a specific contract to provide our specialized diagnostic services to their insured patients at specified rates of reimbursement. We were generally subject to reimbursement as a non-contracting provider for approximately half of our revenues for the three and nine months ended September 30, 2008 and 2007. Use of a non-contracting provider typically results in greater coinsurance or copayment requirements for the patient, unless we elect to treat them as in-network in accordance with applicable law, which results in decreased revenues because we do not generally collect the full applicable out-of-network patient coinsurance or copayment obligations. In instances where we are prohibited by law from treating these patients as in-network, thus requiring them to pay additional costs or copayments, such patients may express concern about these additional costs to their hem/onc. As a result, that hem/onc may reduce or avoid prescribing our services for such patients, which would adversely affect our results of operations and financial condition.

 

Should any of the third party payors with whom we are not contracted insist that we enter into a contract for the specialized diagnostic services we provide, the resulting contract may contain pricing and other terms that are materially less favorable to us than the terms under which we currently operate. If revenues from a particular payor increase, there is heightened risk that such a third party payor will insist that we enter into contractual arrangements that contain such terms. If we refuse to enter into a contract with such a third party payor, they may refuse to cover and reimburse for our services, which may lead to a decrease in case volume and a corresponding decrease in our revenues. If we contract with such a third party payor, although our case volume may increase as a result of the contract, our revenues per case under the contractual agreement and gross margins may decrease. The overall net result of contracting with third party payors may adversely affect our business, results of operations and financial condition.

 

*                 Changes in regulations, payor policies or contracting arrangements with payors or changes in other laws, regulations or policies may adversely affect coverage or reimbursement for our specialized diagnostic services, which may decrease our revenues and adversely affect our results of operations and financial condition.

 

Governmental payors, private insurers and other private payors have implemented and will continue to implement measures to control the cost, utilization and delivery of healthcare services, including clinical laboratory and pathology services. Congress has from time to time considered and implemented changes to laws and regulations governing healthcare service providers, including specialized diagnostic service providers. These changes have adversely affected and may in the future adversely affect coverage for clinical laboratory and pathology services, including the specialized diagnostic services we provide. In addition, as a result of the focus on healthcare reform in connection with the 2008 Presidential election, there is risk that Congress may implement changes in laws and regulations governing healthcare service providers, including measures to control costs or reductions in reimbursement levels, which may have an adverse impact on our business. We also believe that healthcare professionals, including hem/oncs, will not use our services if third party payors do not provide adequate coverage and reimbursement for them. These changes in federal, state, local and third party payor regulations or policies may decrease our revenues and adversely affect our results of operations and financial condition.

 

For approximately half of our revenues for the three and nine months ended September 30, 2008 and 2007, we were generally subject to reimbursement as a non-contracting provider and payments to us as a non-contracting provider can be changed by third party payors at any time. We will continue to be a non-contracting provider until such time as we enter into contracts with third party payors for whom we are not currently contracted. We estimate contractual allowances with respect to revenues from third party payors with whom we are not currently contracted. During the three months ended September 30, 2008, we recorded positive changes in prior period accounting estimates to reduce contractual allowances, which increased our revenues by $2.5 million, of which $1.6 million pertains to the six months ended June 30, 2008. During the nine months ended September 30, 2008, we recorded positive changes in prior year accounting estimates to reduce contractual allowances, which increased our revenues by $2.2 million. In comparison, our revenues increased by $612,000 and $828,000 for the three and nine months ended September 30, 2007, respectively, as a result of changes in such prior period accounting estimates. Because a substantial portion of our revenues is from third party payors with whom we are not currently contracted, it is likely that we will be required to make positive or negative adjustments to accounting estimates

 

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with respect to contractual allowances in the future (as we have made in each of the last several quarters), which may adversely affect our results of operations, our credibility with financial analysts and investors and our stock price. Although during the past several quarters we have experienced favorable changes in accounting estimates resulting in net increases in our revenues, it is possible that future adjustments may be less favorable and may result in net decreases in our revenues, which would adversely affect our results of operations.

 

Increased competition, including from competitors replicating our key service offerings in the future and the failure to provide a higher quality of service than that of our competitors could adversely affect our revenues and profitability.

 

The laboratory services industry generally is intensely competitive both in terms of service and price and it continues to undergo significant consolidation, permitting larger clinical laboratory service providers to increase cost efficiencies and change service levels, resulting in more intense competition. Most of our existing competitors and many potential competitors have substantially greater financial, selling, logistical and laboratory resources, more experience in dealing with third party payors for the services we provide and greater market penetration, purchasing power and marketing budgets, as well as more experience in providing diagnostic services.

 

As a specialized diagnostic service provider, we rely extensively on our high quality of service to attract and retain community-based hem/oncs and other healthcare professionals as our customers at the expense of our larger competitors. We compete primarily on the basis of the quality of testing, reporting and information systems, reliability in patient sample transport, reputation in the medical community and access to our highly qualified hempaths. For example, we provide treating hem/oncs with telephonic access on an almost real-time basis to the specific hempath that generates a report and analysis on the specific patient. Our failure to provide services superior to the laboratories with which we compete could adversely affect our revenues and profitability.

 

Because we do not rely on our intellectual property portfolio to impede others from copying our business, there are no significant barriers to entry into our business and new or existing laboratories could replicate our key service offerings and business model and enter our market to compete with us with relatively low upfront investments, which would adversely affect our business and prospects.

 

We are highly dependent on Cartesian Medical Group, Inc. for the services of our hempaths and any significant difficulties in recruiting or retaining these highly trained hempaths could adversely affect our revenues and results of operations.

 

Our business is highly dependent on the availability of hempaths, who provide professional services to us through Cartesian. Cartesian is actively recruiting additional hempaths to work with us as we continue to expand our business. There are currently approximately 1,500 hempaths licensed in the United States and only approximately 75 new hempaths receive board certification in the United States each year. Our PSA with Cartesian is automatically renewed on a yearly basis but may be terminated by us at any time on 60 days’ prior written notice and either party may terminate the PSA upon the other party’s uncured material breach. Should Cartesian be unable to retain the hempaths that provide professional services to us, or if Cartesian fails in its efforts to recruit additional hempaths to provide us professional services, our ability to maintain and grow our business may be impaired. In addition, Cartesian may be required to offer higher compensation to hempaths in connection with recruitment and retention efforts and these increased compensation expenses would be reflected in the amount we pay to Cartesian through the PSA. We may be unable to recover these increased expenses through price increases or reimbursements for our diagnostic services. In addition, if Cartesian were to experience significant turnover in hempaths, our ability to perform our specialized diagnostic services and our revenues and results of operations could be adversely affected.

 

We must hire and retain qualified sales representatives to grow our sales.

 

Our ability to retain existing customers for our specialized diagnostic services and attract new customers is dependent upon retaining existing sales representatives and hiring new sales representatives, which is an expensive and time-consuming process. We face intense competition for qualified sales personnel and our inability to hire or retain an adequate number of sales representatives could limit our ability to maintain or expand our business and increase sales. Even if we are able to increase our sales force, our new sales personnel may not commit the necessary resources or provide sufficient high quality service and attention to hem/oncs to effectively market and sell our specialized diagnostic services. If we are unable to maintain and expand our marketing and sales networks or if our sales personnel do not perform to our high standards, we may be unable to maintain or grow our existing business and our results of operations and financial condition will likely suffer accordingly.

 

Our sales personnel have developed and maintain close relationships with a number of healthcare professionals. In particular, our sales force focuses its efforts on developing relationships with community-based hem/oncs and other healthcare professionals who are

 

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decision makers in their offices. Our sales depend on the use of our specialized diagnostic services by these community-based hem/oncs and other healthcare professionals and successful marketing of our services depends on educating these community-based hem/oncs and other healthcare professionals as to the distinctive characteristics, benefits, high quality and value of our specialized diagnostic services compared to those of our competitors.

 

If a sales representative ceases employment, we risk the loss of customer goodwill based on the impairment of relationships developed between the sales representative and the healthcare professionals for whom the sales representative was responsible. This is particularly a risk if the representative goes to work for a competitor, as the healthcare professionals that are our customers may choose to use a competitor’s services based on their relationship with the departed sales representative.

 

If we fail to attract and retain key management and other personnel, we may be unable to successfully maintain or develop our business.

 

Our success depends on our continued ability to attract, retain and motivate highly qualified management, laboratory and other personnel. For example, we are highly dependent on the operational and financial expertise of our executive officers. The loss of the services of any of our executive officers, particularly Tina S. Nova, Ph.D., our president and chief executive officer, could impede our growth. In particular, our executive officers currently perform all of our policy-making functions, are in charge of our principal business units, divisions and functions and are solely responsible for all key decisions. We are also dependent on our key employees and consultants, who are important to our business and assist and support our executive officers in implementing and executing these officers’ key decisions. If we lose any of our executive officers or key employees and consultants, other of these individuals may be required to fulfill his or her duties and spend time finding a replacement. We may not be able to find suitable replacements and our business may be harmed as a result. We do not maintain “key woman” or “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. We employ our executive officers and key employees on an at-will basis and their employment can be terminated by them or us at any time.

 

Our industry has experienced a high rate of turnover of management personnel in recent years. In addition to the intense competition for qualified personnel in the healthcare industry, the San Diego area is characterized by a high cost of living, particularly for housing. As such, we could have difficulty attracting experienced personnel to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will impede significantly the achievement of our operational objectives, our revenue growth and our ability to implement our business strategy.

 

*                 We may experience difficulties in managing our growth and our growth rate may decline.

 

Our revenues have grown to $32.1 million and $82.2 million for the three and nine months ended September 30, 2008, respectively, from $16.2 million and $40.8 million for the comparable periods in 2007. This growth has put significant pressure on our systems and operations. As of September 30, 2008, we employed 246 employees, including Cartesian employees and six part-time employees. Our current organization, and our systems and facilities currently in place, may not be adequate to support our future growth. In order to effectively manage our operations and any significant growth, we may need to:

 

·                  scale our internal infrastructure, including establishing a new administrative facility, building out additional laboratory space in our existing facilities and establishing a second laboratory facility, while continuing to provide quality services on a timely basis to community-based hem/oncs and other customers;

 

·                  maintain and strengthen our relationships with our hem/onc customers as we increase the number of our sales and marketing personnel and increase our presence in the various geographic markets we serve;

 

·                  attract and retain sufficient numbers of talented employees and consultants, including sales personnel, hempaths, CSCs, scientists, laboratory technicians and administrative employees, to handle the increasing number of tests we are requested to conduct;

 

·                  manage our relationship with Federal Express to ensure its ability to handle increasing sample transport and deliveries;

 

·                  manage our relationships with third parties for the provision of certain services and the manufacture and supply of certain test kits, reagents and other laboratory materials;

 

·                  continue to enhance our compliance and quality assurance systems; and

 

·                  continue to improve our operational, financial and management controls and reporting systems and procedures.

 

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If we are not able to successfully implement the tasks necessary to further expand our operations, our business, including the quality of our services and our billing, reimbursement, compliance and quality assurance systems, our results of operations and our financial results could be adversely affected. In addition, as our revenues grow, our period over period growth rate may decline.

 

*                 We are currently expanding our infrastructure, including through the acquisition and development of additional office space and the expansion of our current laboratory capacity at our existing facility and we intend to further expand our infrastructure by establishing a new laboratory facility and implementing additional backup systems, which, among other things, could divert our resources and may cause our margins to suffer.

 

In February 2008, we entered into a two-year lease (with three one-year extension options) for additional office space in Carlsbad, California to house our expanding billing and customer service departments. The noncancelable future minimum payments under the lease totaled $293,000, $361,000 and $30,000 for the years ending December 31, 2008, 2009 and 2010, respectively. In connection with the April 2008 lease noted below, the February 2008 lease was terminated in August 2008. As such, the 2008 payments under this contract have been transferred and will increase the noncancelable future minimum lease payments under the April 2008 lease. In addition, the 2009 and 2010 future minimum payments of $361,000 and $30,000, respectively, were cancelled.

 

In April 2008, we entered into a six-year operating lease beginning January 1, 2009 for additional office space in Carlsbad, California to relocate and house our future administration offices commencing as of the date of substantial completion of improvements, estimated to occur in late 2008. Our billing and customer service departments relocated to this facility in August 2008 at the time of the lease termination discussed above. The lease contains one five-year extension option and is subject to annual rent increases. In September 2008, we amended the lease to include an additional suite in the building to house our human resources department. Our existing building will be fully dedicated to clinical laboratory applications when the administration functions are moved in late 2008 to our new headquarters facility. The amended noncancelable future minimum payments under the lease total approximately $73,000, $1.5 million, $1.5 million, $1.6 million, $1.6 million and $3.4 million in 2008, 2009, 2010, 2011, 2012 and thereafter, respectively.

 

Although all our facilities are in close proximity, there may be logistical issues that arise by virtue of separating these departments from the rest of our operations, including issues related to information systems integration and connectivity speed.

 

Moreover, in order to better serve our expanding customer base, to create a backup to our current laboratory facility and to gain additional referrals for our specialized diagnostic services, we intend to expand our infrastructure, including establishing a second laboratory facility in another geographic market and expanding further our backup systems. Although we currently anticipate selecting a site for our new facility in late-2009, in order to establish the new laboratory facility, we will be required to spend considerable time and resources securing adequate space, constructing the facility, obtaining the federal, state and local certifications required by all applicable laws and regulations, recruiting and training employees and establishing the additional operational, logistical and administrative infrastructure necessary to support a second facility. Even after the new laboratory facility is operational, it may take time for us to derive the same economies of scale as in our existing facility. Moreover, we may suffer reduced economies of scale in our existing laboratory facility as we seek to balance the amount of work allocated to each laboratory facility. Similarly, we may invest in new backup systems in order to prevent the interruption in our current systems, which may be costly and would take time and resources to implement. Each expansion of our facilities or systems could divert resources, including the focus of our management, away from our current business. In addition, each expansion of our facilities may increase our costs and potentially decrease operating margins, both of which would, individually or in the aggregate, negatively impact our business, financial condition and results of operations. We will need to continue to expand our managerial, operational, financial, sales, marketing and other infrastructure in order to adequately manage our business and provide support for our services. In addition, to the extent our service levels in our existing or new facilities suffer, this may adversely impact our business, financial condition and results of operations.

 

If our Carlsbad laboratory facility becomes inoperable, we will be unable to perform our specialized diagnostic services and our business will be harmed.

 

We currently do not have redundant laboratory facilities. We perform all of our diagnostic testing in our laboratory facility located in Carlsbad, California. Carlsbad is situated on or near earthquake fault lines and is located in an area that has experienced severe wildfires during the past several years. In addition, we do not have redundant systems for all of our business processes. Our facilities, the equipment we use to perform our tests and services and our other business process systems would be costly to replace and could require substantial time to repair or replace. The facilities may be harmed or rendered inoperable by natural or people-made disasters, including earthquakes, wildfires, floods, acts of terrorism or other criminal activities, infectious disease outbreaks and power outages, which may render it difficult or impossible for us to perform our tests for some period. In addition, such events may

 

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temporarily interrupt our ability to receive specimens or materials from our suppliers and to have access to our various systems necessary to operate our business. For example, in 2007 we experienced a power outage at our Carlsbad laboratory facility and the evacuation of our facilities as a result of severe wildfires. Although our backup generator and other backup procedures and systems allowed us to continue our operations without material interruption, we cannot assure you that similar incidents will not adversely affect our business in the future. The inability to perform our tests and services would result in the loss of customers and harm our reputation and we may be unable to regain those customers in the future. Our insurance carriers and insurance policies covering damage to our property and the disruption of our business may become financially unstable or may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

 

In the event our laboratory facility is damaged or destroyed, we would need to engage a third party to perform laboratory testing services on our behalf. In order to rely on a third party to perform these testing services, we could only use another facility with established state licensure and CLIA accreditation. We cannot assure you that we would be able to find another CLIA-certified facility, or that another laboratory would be willing to perform the necessary tests for us on commercially reasonable terms. Finding a new laboratory that meets the required state licensure and CLIA accreditation standards or developing new systems necessary to operate our business would be time-consuming and costly and result in delays in our ability to provide our specialized diagnostic services or to provide the same level of quality in our services as we currently provide, which would harm our reputation and adversely affect our business, results of operations and financial condition.

 

*                 We incur financial risk related to collections.

 

Substantially all of our revenues are derived from specialized diagnostic services for which we bill on a fee-for-service basis. Billing for diagnostic services is a complex process and we bill many different payors such as insurance companies, governmental payor programs and patients, each of which has different billing requirements. Although we have experienced favorable trends in the collection of accounts receivable and related reductions to our provisions for doubtful accounts, we face risks in our collection efforts, including potential write-offs of doubtful accounts and long collection cycles for accounts receivable, including reimbursements by third party payors, such as Medicare, Medicaid and other governmental payor programs, hospitals, private insurance plans and managed care organizations. In addition, increases in write-offs of doubtful accounts, delays in receiving payments or potential retroactive adjustments and penalties resulting from audits by payors could adversely affect our business, results of operations and financial condition. As of September 30, 2008, we had an allowance for doubtful accounts of $3.3 million, which includes net write-offs and recoveries of $611,000 for the nine months ended September 30, 2008.

 

We or our suppliers and/or manufacturers may be subject to litigation relating to, among other things, payor and customer disputes, regulatory actions, professional liability, intellectual property, employee-related matters, product liability and other potential claims, which could adversely affect our business.

 

We or our suppliers and/or manufacturers may become subject in the ordinary course of business to material litigation related to, among other things, payor or customer disputes, professional liability, regulatory actions, intellectual property, employee-related matters, product liability and other potential claims, as well as investigations by governmental agencies and governmental payors relating to the specialized diagnostic services we provide. Responding to these types of claims, regardless of their merit, could result in significant expense and divert the time, attention and resources of our management. Legal actions could result in substantial monetary damages as well as significant harm to our reputation with community-based hem/oncs and other healthcare professionals and with payors, which could adversely affect our business, financial condition and results of operations.

 

We, Cartesian and/or our hempaths may be sued, or may be added as an additional party, under physician liability or other liability law for acts or omissions by our hempaths, laboratory personnel, CSCs, and other employees and consultants, including but not limited to being sued for misdiagnoses or liabilities arising from the professional interpretations of test results. We, Cartesian and/or our hempaths may periodically become involved as defendants in medical malpractice and other lawsuits and are subject to the attendant risk of substantial damage awards, in particular in connection with our COMPASS service offering. Our hempaths are insured for medical malpractice risks on a claims-made basis under traditional professional liability insurance policies. We also maintain general liability insurance that covers certain claims to which we may be subject. Our general insurance does not cover all potential liabilities that may arise, including governmental fines and penalties that we may be required to pay, liabilities we may incur under indemnification agreements and certain other uninsurable losses that we may suffer. It is possible that future claims will not be covered by or will exceed the limits of our insurance coverage.

 

We and the suppliers and manufacturers of the diagnostic tests we perform, which are critical to the performance of our specialized diagnostic services, may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that their diagnostic tests infringe the intellectual property rights of these third parties. In such event, we could no longer have access to, we may be prohibited from marketing or performing, or we may be subject to liabilities

 

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or litigations relating to such diagnostic tests unless we obtained a license from such third party. A license may not be available to us on acceptable terms, if at all. If we are unable to license diagnostic tests that are important to our specialized diagnostic services, our business, financial condition and results of operations may be adversely affected.

 

We rely on a limited number of third parties for manufacture and supply of all of our laboratory instruments, tests and materials, including consumables, and we may not be able to find replacement suppliers or manufacturers in a timely manner in the event of any disruption, which could adversely affect our business.

 

We rely on third parties for the manufacture and supply of all of our laboratory instruments, equipment and materials, including consumables such as reagents and disposable test kits, that we need to perform our specialized diagnostic services and rely on a limited number of suppliers for certain laboratory materials and some of the laboratory equipment with which we perform our diagnostic services. We do not have long-term contracts with our suppliers and manufacturers that commit them to supply equipment and materials to us. Certain of our suppliers provide us with analyte specific reagents, or ASRs, which serve as building blocks in the diagnostic tests we conduct in our laboratory. These suppliers are subject to regulation by the U.S. Food and Drug Administration, or FDA, and must comply with federal regulations related to the manufacture and distribution of ASR products. Because we cannot ensure the actual production or manufacture of such critical equipment and materials, or the ability of our suppliers to comply with applicable legal and regulatory requirements, we may be subject to significant delays caused by interruption in production or manufacturing. If any of our third party suppliers or manufacturers were to become unwilling or unable to provide this equipment or these materials in required quantities or on our required timelines, we would need to identify and acquire acceptable replacement sources on a timely basis. While we have developed alternate sourcing strategies for the equipment and materials we use, we cannot be certain that these strategies will be effective and even if we were to identify other suppliers and manufacturers for the equipment and materials we need to perform our specialized diagnostic services, there can be no assurance that we will be able to enter into agreements with such suppliers and manufacturers or otherwise obtain such items on a timely basis or on acceptable terms, if at all. If we encounter delays or difficulties in securing necessary laboratory equipment or materials, including consumables, we would face an interruption in our ability to perform our specialized diagnostic services and experience other disruptions that would adversely affect our business, results of operations and financial condition.

 

*                 Performance issues, service interruptions or price increases by our shipping carrier could adversely affect our business, results of operations and financial condition and harm our reputation and ability to provide our specialized diagnostic services on a timely basis.

 

Expedited, reliable shipping is essential to our operations. One of our marketing strategies entails highlighting the reliability of our point-to-point transport of patient samples.

 

We rely almost exclusively on a single carrier, Federal Express, for reliable and secure point-to-point transport of patient bone marrow and other samples to our laboratory and enhanced tracking of these patient samples. Federal Express has tailored some of its systems and processes to meet our specific needs in providing high quality services to our hem/onc customers. In our specialty diagnostic field, patient samples more often than not include bone marrow biopsies, which are both technically difficult for a physician to obtain and extremely uncomfortable for patients to endure. Should Federal Express encounter delivery performance issues such as loss, damage or destruction of a sample, it would be difficult to replace our patient samples in a timely manner and such occurrences may damage our reputation and lead to decreased referrals from physicians for our specialized diagnostic services and increased cost and expense to our business. In addition, any significant increase in shipping rates or fuel surcharges could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters or other service interruptions by delivery services we use would adversely affect our ability to receive and process patient samples on a timely basis.

 

If Federal Express or we were to terminate our relationship, we would be required to find another party to provide expedited, reliable point-to-point transport of our patient samples. There are only a few other providers of such nationwide transport services and there can be no assurance that we will be able to enter into arrangements with such other providers on acceptable terms, if at all. Finding a new provider of transport services would be time-consuming and costly and result in delays in our ability to provide our specialized diagnostic services. Even if we were to enter into an arrangement with such provider, there can be no assurance that they will provide the same level of quality in transport services currently provided to us by Federal Express. If the new provider does not provide the required quality and reliable transport services, it could adversely affect our business, reputation, results of operations and financial condition.

 

Proprietary trademarks, service marks, trade secrets and unpatented expertise are very important to our business.

 

We use numerous trademarks and service marks to identify the products and services we offer, some of which have been registered with the U.S. Patent and Trademark Office, or USPTO, and others of which are undergoing USPTO review. In addition,

 

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we are seeking registration of the name Genoptix in additional fields of use. We cannot guarantee that any of the trademarks or service marks for which we have applied for registration will be granted. Moreover, should a third party challenge one or more of our trademarks or service marks, we cannot guarantee that we would prevail in that challenge. Despite the use of our trademarks or service marks in connection with our services, we are not the sole person entitled to use the names COMPASS or CHART in every category in the United States. For example, third parties have registered the name COMPASS in the United States in the medical field and other categories. None of these third parties has contacted us with a claim that our COMPASS trademark infringes their rights. We cannot guarantee that a third party with rights in a COMPASS or CHART trademark, or in another trademark we use, will not assert those rights against us in the future, by opposing one of our trademark applications, petitioning to cancel one of our trademark registrations, or filing suit against us for trademark infringement seeking damages and/or an injunction to stop us from using our mark.

 

Although we have taken steps to protect our trade secrets and unpatented expertise, including entering into confidentiality agreements with third parties and confidential information and inventions agreements with employees, consultants and advisors, third parties may still be able to obtain this information or we may be unable to protect our rights. There can be no assurance that binding agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors. Enforcing a claim that a third party illegally obtained and is using our trade secrets or unpatented expertise is expensive and time-consuming and the outcome is unpredictable. Moreover, our competitors may independently develop equivalent knowledge, methods and expertise and we would not be able to prevent their use.

 

If technological innovation or prophylactic treatments were to reduce the need to conduct diagnostic testing on blood and bone marrow samples or allow our customers or other third parties to perform specialized diagnostic services similar to ours, our business, prospects, results of operations and financial condition could be adversely affected.

 

In order for hem/oncs to arrive at the correct diagnosis, choose or modify appropriate therapeutic regimens and monitor the effectiveness of these regimens, they currently require highly specialized diagnostic services that analyze blood and bone marrow samples. We focus our diagnostic efforts primarily on specific malignancies of the blood and bone marrow. Serial blood and bone marrow examinations are typically performed to follow the progress of the disease and the patient’s response to therapy. Technological innovations or other advances in medicine that result in the creation of enhanced diagnostic tools may enable other clinical laboratories, hospitals, physicians or other medical providers, or patients, to provide specialized diagnostic services similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible. Advances in technology or medicine may also result in a cure or prophylactic treatment for some of the diseases on which we focus which could reduce or eliminate the need to obtain and analyze bone marrow samples. This could substantially reduce or eliminate our market opportunity and adversely affect our business, prospects, results of operations and financial condition.

 

*                    Failure in our information systems, or IS, telephone or other systems could significantly disrupt our operations and adversely affect our business and financial condition.

 

IS and telephone systems are used extensively in virtually all aspects of our business, including laboratory testing, sales, billing, customer service, logistics and management of medical data. The success of our business depends on the ability to obtain, process, analyze, maintain and manage this data and periodically enhance our IS, telephone and other systems to facilitate the continued growth of our business. Our management relies on our information systems because:

 

·                  patient samples must be received, tracked and processed on a timely basis;

 

·                  test results must be monitored and reported on a timely basis;

 

·                  billings and collections for all customers must be managed efficiently and accurately;

 

·                  third party ancillary billing services require proper tracking and reporting;

 

·                  pricing and other information related to our services is needed by our sales force and other personnel in a timely manner to conduct business;

 

·                  centralized procurement and test inventory management systems are required for effective test inventory management;

 

·                  regulatory compliance requires proper tracking and reporting; and

 

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·                  proper recordkeeping is required for operating our business, regulatory compliance, managing employee compensation and other personnel matters.

 

Our business, results of operations and financial condition may be adversely affected if, among other things:

 

·                  our IS, telephone or other systems are interrupted or fail for any extended length of time;

 

·                  services relating to our IS, telephone or other systems are not kept current;

 

·                  our IS, telephone or other systems become unable to support expanded operations and increased levels of business;

 

·                  services provided by one or more of our vendors fail to operate within the expected technical parameters;

 

·                  information is lost or unable to be restored or processed; or

 

·                  information security is breached.

 

Our success depends, in part, on the continued and uninterrupted performance of our IS, telephone and other systems, which are vulnerable to damage from a variety of sources, including telecommunications or network failures, computer viruses, natural disasters and physical or electronic break-ins. We are especially vulnerable to losses of patient information, which could result in violations of federal and state privacy laws. Despite the precautionary measures we have taken to prevent breakdowns in our IS and telephone systems, sustained or repeated system failures that interrupt our ability to process test orders, deliver test results or perform tests in a timely manner or that cause us to lose patient information could adversely affect our business, results of operations and financial condition.

 

*                 We may experience difficulty in identifying, acquiring or in-licensing and integrating third parties’ products, services, businesses and technologies into our current infrastructure and we may not be able to successfully execute on and integrate such products, services, businesses or technologies, which could disrupt our business and adversely affect our results of operations and financial condition.

 

An important part of our business strategy is to opportunistically pursue additional technologies, collaborations and acquisitions that will enable us to accelerate the implementation of our strategic plan and to increase the number of customers we serve and the specialized diagnostic services we provide to those customers, including by way of investments in other companies, licensing of technology, co-development arrangements, collaborations, asset purchases and other similar transactions. For example, we currently outsource select specialized services that we offer and we may in the future seek to acquire the necessary capabilities to provide these services internally. Although we are not currently a party to any other agreements or commitments and we have no understandings with respect to any such opportunities, we may seek to expand our services and technologies, on an opportunistic basis and as resources allow, by acquiring or in-licensing products, services, businesses or technologies that we believe are a strategic fit with our business and growth plans. Future acquisitions or in-licensing of products, services, businesses or technologies, however, may entail numerous operational and financial risks including:

 

·                  exposure to unknown liabilities;

 

·                  disruption of our business and diversion of our management’s time and attention;

 

·                  the availability of financing to pay for these transactions;

 

·                  incurrence of substantial debt or dilutive issuances of securities to pay for these transactions;

 

·                  higher than expected acquisition, in-licensing and integration costs;

 

·                  increased amortization expenses;

 

·                  difficulties in and costs of combining the operations and personnel of any acquired or in-licensed products, services, businesses or technologies with our operations and personnel;

 

·                  increased regulatory, compliance and litigation risk;

 

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·                  impairment of relationships with key suppliers or customers of any acquired or in-licensed products, services, businesses or technologies due to changes in management and ownership; and

 

·                  inability to retain key employees of any acquired or in-licensed products, services, businesses or technologies.

 

Finally, we may devote resources to potential acquisitions, in-licensing or collaboration opportunities that are never completed, acquired by others, or fail to realize the anticipated benefits of such efforts. Any of these matters could disrupt our business and adversely affect our results of operations and financial condition.

 

We use biological and hazardous materials that require considerable expertise and expense for handling, storage or disposal and may result in claims against us.

 

We work with hazardous materials, including chemicals, biological agents and compounds, blood and bone marrow samples and other human tissue, that could be dangerous to human health and safety or the environment. Our operations also produce hazardous and biohazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive and current or future environmental laws and regulations may impair business efforts. If we do not comply with applicable regulations, we may be subject to fines and penalties.

 

In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. Our general liability insurance and/or workers’ compensation insurance policy may not cover damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources and our operations could be suspended or otherwise adversely affected.

 

*                 We have a limited operating history, have had net operating losses for several years, had an accumulated deficit of $16.0 million as of September 30, 2008, and only recently became profitable, and we are unable to predict with certainty whether we will remain profitable.

 

We are an early stage company with a limited operating history. We did not commence selling our specialized diagnostic services until the third quarter of 2004 and only became profitable in the first quarter of 2007. Consequently, any predictions about our future performance may not be as accurate as they could be if we had a longer history of successfully commercializing specialized diagnostic services.

 

We have incurred losses in each full fiscal year since our inception prior to 2007. As of September 30, 2008, we had an accumulated deficit of $16.0 million. For the years ended December 31, 2005 and 2006, we had net losses of $9.2 million and $3.8 million, respectively. During the three months ended September 30, 2008, we recorded positive changes in prior period accounting estimates to reduce contractual allowances, which increased our revenues by $2.5 million, of which $1.6 million pertains to the six months ended June 30, 2008. During the nine months ended September 30, 2008, we recorded positive changes in prior year accounting estimates to reduce contractual allowances, which increased our revenues by $2.2 million. In comparison, our revenues increased by $612,000 and $828,000 for the three and nine months ended September 30, 2007, respectively, as a result of changes in such prior period accounting estimates. We may incur operating losses in the future as we expand our infrastructure, increase selling expenses and increase general and administrative expenses to comply with public company obligations or if we are unable to continue to maintain or increase our revenues or control expenses. Because of the numerous risks and uncertainties associated with our growth prospects, sales and marketing and other efforts and other factors, we are unable to predict with certainty whether we will remain profitable or predict the extent of our profitability or future losses.

 

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us.

 

In addition to our employees, we engage the services of consultants to assist us with certain aspects of our business. Many of these employees or consultants were previously employed at or may have previously been or are currently providing consulting services to, other clinical laboratories or diagnostics companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or these employees or consultants have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or their former or current customers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

 

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Risks Relating to Regulatory and Compliance Matters

 

*                    We conduct business in a heavily regulated industry and changes in regulations or violations of regulations may, directly or indirectly, reduce our revenues, adversely affect our results of operations and financial condition and harm our business.

 

The clinical laboratory testing industry is highly regulated and there can be no assurance that the regulatory environment in which we operate will not change significantly and adversely in the future. In particular, there is risk of healthcare reform or other legislative activity following the 2008 Presidential election, which may result in changes in the regulatory or payor environment that may adversely affect our business. Areas of the regulatory environment that may affect our ability to conduct business include, without limitation:

 

·                  federal and state laws applicable to billing and claims payment and/or regulatory agencies enforcing those laws and regulations;

 

·                  federal and state laboratory anti-mark-up laws;

 

·                  federal and state anti-kickback laws;

 

·                  federal and state false claims laws;

 

·                  federal and state self-referral and financial inducement laws, including the federal physician anti-self-referral law, or the Stark Law;

 

·                  coverage and reimbursement levels by Medicare, Medicaid, other governmental payors and private insurers;

 

·                  restrictions on reimbursements for our services;

 

·                  federal and state laws governing laboratory testing, including CLIA;

 

·                  federal and state laws governing the development, use and distribution of diagnostic medical tests known as “home brews”;

 

·                  the Health Insurance Portability and Accountability Act of 1996, or HIPAA;

 

·                  federal and state regulation of privacy, security and electronic transactions;

 

·                  state laws regarding prohibitions on the corporate practice of medicine;

 

·                  state laws regarding prohibitions on fee-splitting;

 

·                  federal, state and local laws governing the handling and disposal of medical and hazardous waste;

 

·                  Occupational Safety and Health Administration rules and regulations; and

 

·                  changes to other federal, state and local laws, including tax laws.

 

These laws and regulations are extremely complex and in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. While we believe that we are currently in material compliance with applicable laws and regulations, a determination that we have violated these laws, or the public announcement that we are being investigated for possible violations of these laws, would adversely affect our business, prospects, results of operations and financial condition. In addition, a significant change in any of these laws may require us to change our business model in order to maintain compliance with these laws, which could reduce our revenues or increase our costs and adversely affect our business, prospects, results of operations and financial condition.

 

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*                 If we fail to comply with healthcare fraud and abuse laws that govern, among other things, sales and marketing, billing and claims processing practices, we could face substantial penalties and our business, results of operations and financial condition could be adversely affected.

 

We are subject to various state and federal healthcare fraud and abuse laws and regulations, including, but not limited to:

 

·                  the federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under governmental payor programs such as Medicare and Medicaid;

 

·                  the federal False Claims Act that prohibits individuals or entities from knowingly presenting, or causing to be presented to the federal government, claims for payment that are false or fraudulent;

 

·                  HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

 

·                  the Stark Law, which prohibits a physician from making a referral to an entity for certain designated health services reimbursed by Medicare or Medicaid if the physician (or a member of the physician’s family) has a financial relationship with the entity and which also prohibits the submission of any claim for reimbursement for designated health services furnished pursuant to a prohibited referral; and

 

·                  state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third party payor, including commercial insurers.

 

Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a clinical laboratory’s participation in or reimbursement from governmental payor programs, criminal fines and imprisonment. Although we endeavor to comply in all material respects with these rules and regulations, our sales and marketing, billing and claims processing practices may not, in all cases, meet all of the criteria for safe harbor protection or exemptions from liability under these laws. For example, in most cases, patients who utilize service providers that are not participants in a preferred provider network are subject to increased financial obligations in the form of greater coinsurance or copayment requirements. For approximately half of our revenues for the three and nine months ended September 30, 2008 and 2007, we were generally subject to reimbursement as a non-contracting provider. In order to maintain our competitiveness with other clinical laboratories, except as required by applicable laws, we frequently accept third party insurance payment as payment in full and, in turn, waive all or a part of a patient’s coinsurance obligations such that the patient’s financial burden is no greater than if he or she would have selected an in-network provider. A successful challenge to our practice of accepting third party insurance payments as payment in full under the laws discussed above could adversely affect our business, results of operations and financial condition.

 

*                 Our failure to comply with governmental payor regulations could result in our being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would decrease our revenues and adversely affect our results of operations and financial condition.

 

Reimbursement from Medicare and Medicaid accounted for approximately 37% and 39% of our revenues for the three and nine months ended September 30, 2008, respectively. The Medicare program is administered by CMS which, like the states that administer their respective state Medicaid programs, imposes extensive and detailed requirements on diagnostic services providers, including, but not limited to, rules that govern how we structure our relationships with physicians, how and when we submit reimbursement claims and how we provide our specialized diagnostic services. Our failure to comply with applicable Medicare, Medicaid and other governmental payor rules could result in our inability to participate in a governmental payor program, our returning funds already paid to us, civil monetary penalties, criminal penalties and/or limitations on the operational function of our laboratory. If we were unable to receive reimbursement under a governmental payor program, a substantial portion of our revenues would be lost, which would adversely affect our results of operations and financial condition.

 

Our business could be harmed by future interpretations of clinical laboratory mark-up prohibitions.

 

Our laboratory currently uses the services of outside reference laboratories to provide certain complementary laboratory services to those services provided directly by our laboratory. Although Medicare policies do not prohibit certain independent-laboratory-to-independent-laboratory referrals and subsequent mark-up for services, California and other states have rules and regulations that prohibit or limit the mark-up of these laboratory-to-laboratory services. A challenge to our charge-setting procedures under these rules

 

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and regulations could have a material adverse effect on our business, results of operations and financial condition.

 

*                 Our business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, the law or regulations of the CLIA or those of other state or local agencies.

 

We are subject to CLIA, which is administered by CMS and extends federal oversight to virtually all clinical laboratories by requiring that they be certified by the federal government or by a federally-approved accreditation agency. CLIA is designed to ensure the quality and reliability of clinical laboratories by mandating specific standards in the areas of personnel qualifications, administration and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The sanction for failure to comply with CLIA requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties. If a laboratory is certified as “high complexity” under CLIA, the laboratory may obtain ASRs, which are used to develop in-house diagnostic tests known as “home brews.” We received our CLIA accreditation certificate as a “high complexity” laboratory in mid-2004. To renew this certificate, we are subject to survey and inspection every two years as well as the possibility of unannounced surveys at any time. Our CLIA accreditation was last renewed in March 2008.

 

We are also subject to regulation of laboratory operations under state clinical laboratory laws. State clinical laboratory laws may require that laboratories and/or laboratory personnel meet certain qualifications, specify certain quality controls or require maintenance of certain records. For example, California requires that we maintain a license to conduct testing in California and California law establishes standards for our day-to-day laboratory operations, including the training and skill required of laboratory personnel and quality control. Certain other states, including Florida, Maryland, New York, Pennsylvania and Rhode Island, each require that we hold licenses to test specimens from patients residing in those states and additional states may require similar licenses in the future. Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorizations, which could adversely affect our business and results of operations.

 

Certain of our specialized diagnostic tests take advantage of the “home-brew” exception from the FDA review and any changes to the FDA’s policies with respect to this exception could adversely affect our business and results of operations.

 

Clinical laboratory diagnostic tests that are developed and validated by a laboratory for use in examinations the laboratory performs itself are called “home brew” tests. The FDA maintains that it has authority to regulate the development and use of “home brews” as diagnostic medical devices under the Federal Food, Drug and Cosmetic Act but to date has decided not to exercise its authority with respect to most “home brew” tests as a matter of enforcement discretion. A substantial portion of our specialized diagnostic tests are “home brew” tests for which we have not obtained the FDA premarket clearance or approval. In addition, manufacturers and suppliers of ASRs, which we obtain for use in our “home brews,” are required to register with the FDA, to conform manufacturing operations to the FDA’s Quality System Regulation and to comply with certain reporting and other recordkeeping requirements. The FDA regularly considers the application of additional regulatory controls over the sale of ASRs and the development and use of “home brews” by laboratories such as ours. We cannot predict the extent of the FDA’s future regulation and policies with respect to “home brew” tests and there can be no assurance that the FDA will not require us to obtain premarket clearance or approval for certain of the diagnostic tests that we perform. Any such premarket clearance requirements could restrict or delay our ability to provide our specialized diagnostic services and may adversely affect our business and results of operations.

 

Failure to comply with the HIPAA security and privacy regulations may increase our operational costs.

 

The HIPAA privacy and security regulations establish comprehensive federal standards with respect to the uses and disclosures of personal health information, or PHI, by health plans and healthcare providers, in addition to setting standards to protect the confidentiality, integrity and availability of electronic PHI. The regulations establish a complex regulatory framework on a variety of subjects, including:

 

·                  the circumstances under which uses and disclosures of PHI are permitted or required without a specific authorization by the patient, including but not limited to treatment purposes, activities to obtain payments for services and healthcare operations activities;

 

·                  a patient’s rights to access, amend and receive an accounting of certain disclosures of PHI;

 

·                  the content of notices of privacy practices for PHI; and

 

·                  administrative, technical and physical safeguards required of entities that use or receive PHI electronically.

 

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We have implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy regulations and varying state privacy laws. The federal privacy regulations restrict our ability to use or disclose patient identifiable laboratory data, without patient authorization, for purposes other than payment, treatment or healthcare operations (as defined by HIPAA), except for disclosures for various public policy purposes and other permitted purposes outlined in the privacy regulations. The privacy and security regulations provide for significant fines and other penalties for wrongful use or disclosure of PHI, including potential civil and criminal fines and penalties. Although the HIPAA statute and regulations do not expressly provide for a private right of damages, we also could incur damages under state laws to private parties for the wrongful use or disclosure of confidential health information or other private personal information.

 

Our business could be materially harmed by future interpretation or implementation of state laws regarding prohibitions on the corporate practice of medicine.

 

The manner in which licensed physicians can be organized to perform and bill for medical services is governed by state laws and regulations. Under the laws of some states, including California, business corporations generally are not permitted to employ physicians or to own corporations that employ physicians or to otherwise exercise control over the medical judgments or decisions of physicians. All of the hempaths that we utilize in connection with providing our specialized diagnostic services are employed by Cartesian. Cartesian is a California professional corporation we formed for the purpose of providing professional medical services in conjunction with the diagnostic services that we provide. On December 31, 2005, we entered into the PSA with Cartesian, pursuant to which these hempaths provide professional services to us. Prior to that time, we employed these hempaths, which could result in the potential assertion by regulatory authorities that we were engaged in the corporate practice of medicine.

 

We believe that we currently are in compliance in all material respects with the laws governing the corporate practice of medicine in California. If regulatory authorities or other parties were to assert that we were engaged in the corporate practice of medicine currently or prior to December 31, 2005, or if California laws governing the corporate practice of medicine were to change, we could be required to restructure our contractual and other arrangements and we and/or our hempaths could be subject to civil or criminal penalties. In addition, the provision of our specialized diagnostic services, which rely heavily on the professional services provided by our hempaths, could be interrupted or suspended, which would adversely affect our business, results of operations and financial condition.

 

Risks Relating to Our Finances and Capital Requirements

 

*                 Negative conditions in the global credit markets and financial services and other industries may impair the liquidity of a portion of our investment portfolio or may otherwise adversely affect our business.

 

All of our investment securities are classified as available-for-sale and therefore reported on the balance sheet at market value. Our investment securities consist of corporate debt investment securities, government-sponsored enterprise investment securities and ARS.

 

As of September 30, 2008, we held an ARS with a cost basis of $5.0 million consisting of debt issued by a municipality, which is underwritten by an insurance agency and rated A2 by Moody’s Investors Service and AA by Standard & Poor’s. It is classified as a long-term investment security due to the current illiquidity in the ARS markets. Liquidity is obtained through a Dutch auction at pre-determined intervals, or every 35 days. The recent conditions in the global credit markets have prevented some investors from liquidating their holdings of ARS because the amount of investment securities submitted for sale has exceeded the amount of purchase orders for such investment securities. If there is insufficient demand for the investment securities at the time of an auction, the auction may not be completed and the interest rates may be reset to predetermined higher rates.

 

This auction began failing in February 2008 when sell orders exceeded buy orders at the auction dates. When auctions for this ARS failed, the investment was not readily convertible to cash. The funds associated with this failed auction will not be accessible without loss of principal until the issuer redeems the ARS, a successful auction occurs, a buyer is found outside of the auction process, or the ARS matures in 2038. As such, we may be required to hold it to maturity. Likewise, if the credit ratings of the security issuers deteriorate and any decline in market value is determined to be other-than-temporary, we would be required to adjust the carrying value of the investment through an other-than-temporary impairment charge to the condensed consolidated statement of operations.

 

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The valuation of this security is based on an internally developed valuation analysis of interest rate spreads, the credit quality, underlying assets of the issuer and underwriter, likelihood of a successful auction or redemption in the near term and the ability to obtain liquidity in the near-term. As a result of the estimated fair value, we have recorded a temporary impairment in the valuation of this security of $1.2 million during the three months ended September 30, 2008.The unrealized loss in the current period, net of deferred tax, is included in accumulated other comprehensive (loss) income. Due to the uncertainty related to the timing of liquidity in the ARS market, we have classified this ARS investment security as a long-term asset on our balance sheet with a fair value of $3.8 million as of September 30, 2008. Because we were required to value this security using only subjective inputs, our valuations determined at a later date or by a third party, may be different from the fair values we have determined as of September 30, 2008.

 

We do not currently need to access these funds for operational purposes for the foreseeable future. Based on our ability to access our cash and cash equivalents and short-term securities and our expected operating cash flows, we do not anticipate that the temporary illiquidity of this investment will affect our ability to execute our current business plan.

 

In addition to the continuing deterioration in the global credit markets, the financial services industry and the U.S. economy as a whole have been experiencing a period of substantial turmoil and uncertainty characterized by unprecedented intervention by the United States federal government and the failure, bankruptcy, or sale of various financial and other institutions. The impact of these events on our business and the severity of the current economic crisis is uncertain. It is possible that the current crisis in the global credit markets, the financial services industry and the U.S. economy may adversely affect our business, vendors and prospects as well as our liquidity and financial condition. More specifically, our insurance carriers and insurance policies covering all aspects of our business may become financially unstable or may not be sufficient to cover any or all of our losses and may not continue to be available to us on acceptable terms, or at all.

 

*                    We may need to raise additional capital in the future, which may not be available on favorable terms or at all, which may cause dilution to our existing stockholders or require us to be subject to certain restrictions.

 

We may need to raise additional capital in the future. Our operations have consumed substantial amounts of cash since inception. To date, our sources of cash have been primarily limited to our initial public offering, private placements of preferred stock and debt, and more recently cash flow from operations. We expect to continue to spend substantial amounts of capital to grow our business. To fund such growth, we may raise additional funds through public or private equity offerings or debt financings. We do not know if we will be able to continue to generate cash flow from operations or if we will be able to obtain additional financing on favorable terms, if at all (particularly in light of the difficult current financing environment and weak economic conditions). If we cannot raise funds on acceptable terms, if and when needed, we may not be able to maintain or grow our business at the rate that we currently anticipate and respond to competitive pressures or unanticipated capital requirements, or we may be required to reduce operating expenses, which could significantly harm our business, financial condition and results of operations. In addition, to the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership in our company will be diluted.

 

*                    We expect to continue to incur significant increased costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs.

 

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company, which we currently expect to be at least $2.2 million per year. In addition, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and The NASDAQ Stock Market, or NASDAQ, in the past several years have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls, changes in corporate governance practices and substantial changes in executive compensation disclosure. The SEC and other regulators have continued to adopt new rules and regulations and make additional changes to existing regulations that require our compliance. Our management and other personnel continue to devote a substantial amount of time to these compliance programs and other programs related to being a public company, such as investor relations and monitoring of public company reporting obligations. These rules and regulations will continue to increase our legal and financial compliance costs and will make some activities more time-consuming and costly. As a public company, it is more difficult and more expensive for us to renew director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

 

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The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting. In particular, commencing this year, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management and our independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act, or Section 404. Our testing, or the subsequent testing by our independent registered public accounting firm, may reveal significant deficiencies or material weaknesses in our internal control over financial reporting. We are incurring significant expense and devote substantial management effort toward ensuring compliance with Section 404. If we are not able to comply with the requirements of Section 404 in a timely manner, or if we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to be significant deficiencies or material weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatory authorities, which would entail expenditure of additional financial and management resources.

 

*                    Future changes in financial accounting standards or practices, or existing taxation rules or practices, may cause adverse unexpected revenue or expense fluctuations and affect our reported results of operations.

 

A change in accounting standards or practices, or a change in existing taxation rules or practices, can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. New accounting pronouncements, taxation rules and varying interpretations of accounting pronouncements and taxation practice have occurred and may occur in the future. For example, in September 2008 the State of California passed a law, effective January 1, 2008, to suspend California net operating losses for two-years pertaining to certain corporations doing business within California. This net operating loss suspension had no impact on our income tax benefit, as reported. However, this does require us to pay income tax associated with our taxable income for the tax years 2008 and 2009, which our California deferred net operating loss otherwise would have eliminated. Changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business. Our effective tax rate can also be impacted by changes in estimates of prior years’ items, the outcome of audits by federal, state and foreign jurisdictions and changes in overall levels of income before income tax.

 

Risks Relating to the Securities Markets and Investment in Our Common Stock

 

There may not be a viable public market for our common stock.

 

We cannot predict the extent to which investor interest in our company will sustain an active trading market for our stock on The NASDAQ Global Market or any other stock market or how liquid any such market might remain. If an active public market is not sustained, it may be difficult for our stockholders to sell their shares of common stock at a price that is attractive to them, or at all.

 

*                 Fluctuations in our operating results and market volatility may affect our stock price.

 

The market price of our common stock is volatile and may fluctuate significantly in response to a number of factors, many of which we cannot control, including:

 

·                  changes in coverage and/or reimbursement guidelines and amounts;

 

·                  variations in deductible and coinsurance amounts;