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 NO. 0-28218

 


 

AFFYMETRIX, INC.

(Exact name of Registrant as specified in its charter)

 

DELAWARE

 

77-0319159

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification Number)

 

 

 

3420 CENTRAL EXPRESSWAY

 

 

SANTA CLARA, CALIFORNIA

 

95051

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (408) 731-5000

 


 

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 definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer x

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

(Do not check if a smaller reporting company)

 

 

 

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

 

COMMON SHARES OUTSTANDING ON OCTOBER 31, 2008: 70,202,630

 

 

 



Table of Contents

 

AFFYMETRIX, INC.

 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

3

 

 

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

3

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets at September 30, 2008 and December 31, 2007

 

3

 

 

 

 

 

 

 

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

 

4

 

 

 

 

 

 

 

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

 

5

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

6

 

 

 

 

 

 

Item 2.

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

 

19

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

28

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

28

 

 

 

 

 

PART II. OTHER INFORMATION

 

29

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

29

 

 

 

 

 

 

Item 1A.

Risk Factors

 

29

 

 

 

 

 

 

Item 5.

Other Information

 

38

 

 

 

 

 

 

Item 6.

Exhibits

 

39

 

 

 

 

 

SIGNATURES

 

40

 

2



Table of Contents

 

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

 

AFFYMETRIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2008

 

2007

 

ASSETS:

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

315,151

 

$

288,644

 

Restricted cash

 

7,844

 

 

Available-for-sale securities—short-term portion

 

256,410

 

205,718

 

Accounts receivable, net ($67 in 2008 and $389 in 2007 from Perlegen Sciences)

 

63,464

 

81,941

 

Inventories

 

46,373

 

42,912

 

Deferred tax assets—current portion

 

7,825

 

28,584

 

Notes receivable from employees—current portion

 

 

1,376

 

Prepaid expenses and other current assets

 

15,732

 

17,933

 

Total current assets

 

712,799

 

667,108

 

Available-for-sale securities—long-term portion

 

10,938

 

89,912

 

Property and equipment, net

 

107,087

 

143,884

 

Acquired technology rights, net

 

54,859

 

46,797

 

Goodwill

 

193,000

 

125,050

 

Deferred tax assets—long-term portion

 

45,886

 

18,426

 

Notes receivable from employees—long-term portion

 

 

487

 

Other assets

 

33,522

 

41,927

 

Total assets

 

$

1,158,091

 

$

1,133,591

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

54,290

 

$

61,543

 

Deferred revenue—current portion

 

18,276

 

22,498

 

Total current liabilities

 

72,566

 

84,041

 

Deferred revenue—long-term portion

 

3,668

 

3,922

 

Other long-term liabilities

 

10,451

 

10,971

 

Convertible notes

 

436,250

 

436,250

 

Stockholders’ equity:

 

 

 

 

 

Common stock

 

702

 

692

 

Additional paid-in capital

 

734,390

 

704,189

 

Accumulated other comprehensive income

 

(2,261

)

1,998

 

Accumulated deficit

 

(97,675

)

(108,472

)

Total stockholders’ equity

 

635,156

 

598,407

 

Total liabilities and stockholders’ equity

 

$

1,158,091

 

$

1,133,591

 

 

Note 1:                            The condensed consolidated balance sheet at December 31, 2007 has been derived from the audited consolidated financial statements at that date included in the Company’s Form 10-K for the fiscal year ended December 31, 2007.

 

See accompanying notes.

 

3



Table of Contents

 

AFFYMETRIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

REVENUE:

 

 

 

 

 

 

 

 

 

Product sales ($46 and $843 in 2008 and $355 and $11,456 in 2007 from Perlegen Sciences)

 

$

65,952

 

$

69,727

 

$

203,780

 

$

202,621

 

Services

 

6,132

 

10,829

 

23,557

 

31,617

 

Royalties and other revenue

 

3,105

 

14,430

 

104,338

 

29,490

 

Total revenue

 

75,189

 

94,986

 

331,675

 

263,728

 

COSTS AND EXPENSES:

 

 

 

 

 

 

 

 

 

Cost of product sales ($4 and $446 in 2008 and $166 and $4,494 in 2007 from Perlegen Sciences)

 

32,347

 

28,246

 

90,581

 

76,117

 

Cost of services

 

5,791

 

7,307

 

18,160

 

24,473

 

Cost of royalties and other revenue

 

29

 

39

 

81

 

185

 

Research and development

 

20,739

 

16,489

 

59,098

 

55,143

 

Selling, general and administrative

 

28,409

 

33,300

 

92,782

 

102,800

 

Acquired in-process technology

 

5,100

 

 

5,900

 

 

Restructuring charges

 

14,571

 

5,737

 

29,379

 

12,879

 

Total costs and expenses

 

106,986

 

91,118

 

295,981

 

271,597

 

(Loss) income from operations

 

(31,797

)

3,868

 

35,694

 

(7,869

)

Interest income and other, net

 

1,672

 

291

 

10,830

 

8,382

 

Interest expense

 

(3,497

)

(417

)

(10,634

)

(1,246

)

(Loss) income before income taxes

 

(33,622

)

3,742

 

35,890

 

(733

)

Income tax benefit (provision)

 

1,802

 

(1,162

)

(25,093

)

550

 

Net (loss) income

 

$

(31,820

)

$

2,580

 

$

10,797

 

$

(183

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net (loss) income per common share

 

$

(0.46

)

$

0.04

 

$

0.16

 

$

(0.00

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic net (loss) income per common share

 

68,582

 

68,356

 

68,542

 

68,170

 

Shares used in computing diluted net (loss) income per common share

 

68,582

 

68,725

 

68,650

 

68,170

 

 

 See accompanying notes.

 

4



Table of Contents

 

AFFYMETRIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)
(Unaudited)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net income (loss)

 

$

10,797

 

$

(183

)

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

24,424

 

17,495

 

Amortization of intangible assets

 

8,313

 

6,244

 

Charge for acquired in-process technology

 

5,900

 

 

Amortization of investment premiums, net

 

116

 

109

 

Stock-based compensation

 

6,618

 

7,901

 

Restructuring charges

 

(1,703

)

50

 

Realized (gain) loss on equity investments

 

(47

)

3,249

 

Realized loss (gain) on the sales of investments

 

450

 

(99

)

Deferred tax assets

 

18,445

 

(327

)

Amortization of debt offering costs

 

1,583

 

570

 

Accretion of interest on notes receivable

 

(7

)

(48

)

Loss on disposal of property and equipment

 

25,858

 

1,088

 

Changes in operating assets and liabilities:

 

 

 

 

 

Restricted cash

 

(7,844

)

 

Accounts receivable, net

 

21,509

 

9,315

 

Inventories

 

3,732

 

(2,102

)

Prepaid expenses and other assets

 

4,222

 

(5,604

)

Accounts payable and accrued liabilities

 

(19,176

)

(10,878

)

Deferred revenue

 

(4,476

)

(8,851

)

Other long-term liabilities

 

(520

)

1,427

 

Net cash provided by operating activities

 

98,194

 

19,356

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Capital expenditures

 

(10,809

)

(22,954

)

Purchases of available-for-sale securities

 

(336,258

)

(82,074

)

Proceeds from sales and maturities of available-for-sale securities

 

363,985

 

77,712

 

Acquisition of businesses, net of cash acquired

 

(88,213

)

 

Purchase of non-marketable equity investments

 

(311

)

(800

)

Capital distribution of non-marketable equity investments

 

 

902

 

Net cash used in investing activities

 

(71,606

)

(27,214

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Issuance of common stock, net

 

(35

)

12,227

 

Net cash (used in) provided by financing activities

 

(35

)

12,227

 

Effect of exchange rate changes on cash and cash equivalents

 

(46

)

304

 

Net increase in cash and cash equivalents

 

26,507

 

4,673

 

Cash and cash equivalents at beginning of period

 

288,644

 

119,063

 

Cash and cash equivalents at end of period

 

$

315,151

 

$

123,736

 

 

See accompanying notes.

 

5



Table of Contents

 

AFFYMETRIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2008
(UNAUDITED)

 

NOTE 1—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles 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 footnotes required by U.S. generally accepted accounting principles for complete financial statements. The condensed consolidated financial statements include the accounts of Affymetrix, Inc. and its wholly owned subsidiaries (“Affymetrix” or the “Company”). All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring entries) considered necessary for a fair presentation have been included.

 

Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission on February 29, 2008.

 

Use of Estimates

 

The preparation of the condensed consolidated financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

Reclassification

 

Certain prior year revenue and cost of sales amounts in the Company’s Condensed Consolidated Statements of Operations have been reclassified to conform to the current period presentation.

 

Revenue Recognition

 

Overview

 

The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred, the fee is fixed or determinable, and collectibility is reasonably assured. In instances where final acceptance of the product or system is required, revenue is deferred until all the acceptance criteria have been met.

 

The Company derives the majority of its revenue from product sales of GeneChip® probe arrays, reagents, and related instrumentation that may be sold individually or combined with any of the products, services or other sources of revenue listed below. When a sale combines multiple elements, the Company accounts for multiple element arrangements under Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with Multiple Deliverables, (“EITF 00-21”)

 

EITF 00-21 provides guidance on accounting for arrangements that involve the delivery or performance of multiple products, services and/or rights to use assets. In accordance with EITF 00-21, the Company allocates revenue for transactions or collaborations that include multiple elements to each unit of accounting based on its relative fair value, and recognizes revenue for each unit of accounting when the revenue recognition criteria have been met. The price charged when the element is sold separately generally determines fair value. In the absence of fair value of a delivered element, the Company allocates revenue first to the fair value of the undelivered elements and the residual revenue to the delivered elements. The Company recognizes revenue for delivered elements when the delivered elements have standalone value and the Company has objective and reliable evidence of fair value for each undelivered element. If the fair value of any undelivered element included in a multiple element arrangement cannot be objectively determined, revenue is deferred until all elements are delivered and services have been performed, or until fair value can objectively be determined for any remaining undelivered elements.

 

6



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Product Sales

 

Product sales, as well as revenues from Perlegen Sciences (a related party, see Note 10), include sales of GeneChip® probe arrays, reagents and related instrumentation. Probe array, reagent and instrumentation revenues are recognized when earned, which is generally upon shipment and transfer of title to the customer and fulfillment of any significant post-delivery obligations. Accruals are provided for anticipated warranty expenses at the time the associated revenue is recognized.

 

Services

 

Services revenue includes equipment service revenue; scientific services revenue, which includes associated consumables; and revenue from custom probe array design fees.

 

Revenue related to extended warranty arrangements is deferred and recognized ratably over the applicable periods. Revenue from custom probe array design fees associated with the Company’s GeneChip® CustomExpressÔ and CustomSeqÔ products are recognized when the associated products are shipped.

 

Revenue from scientific and DNA analysis services are recognized upon shipment of the required data to the customer.

 

Royalties and Other Revenue

 

Royalties and other revenue include license revenue; royalties earned from third party license agreements; milestones and royalties earned from collaborative product development and supply agreements; subscription fees earned under GeneChip® array access programs; and research revenue which mainly consists of amounts earned under government grants; and non-recurring intellectual property payments.

 

License revenues are generally recognized upon execution of the agreement unless the Company has continuing performance obligations, in which case the license revenue is recognized ratably over the period of expected performance.

 

Royalty revenues are earned from the sale of products by third parties who have been licensed under the Company’s intellectual property portfolio. Revenue from minimum royalties is amortized over the term of the creditable royalty period. Any royalties received in excess of minimum royalty payments are recognized under the terms of the related agreement, generally upon notification of manufacture or shipment of a product by a licensee.

 

The Company enters into collaborative arrangements which generally include a research and product development phase and a manufacturing and product supply phase. These arrangements may include up-front nonrefundable license fees, milestones, the rights to royalties based on the sale of final product by the partner, product supply agreements and distribution arrangements.

 

Any up-front, nonrefundable payments from collaborative product development agreements are recognized ratably over the research and product development period, and at-risk substantive based milestones are recognized when earned. Any payments received which are not yet earned are included in deferred revenue.

 

Revenue from subscription fees earned under GeneChip® array access programs is recorded ratably over the related supply term.

 

Research revenues result primarily from research grants received from U.S. Government entities or from subcontracts with other life science research-based companies which receive their research grant funding from the U.S. Government. Revenues from research contracts are generated from the efforts of the Company’s technical staff and include the costs for material and subcontract efforts. The Company’s research grant contracts generally provide for the payment of negotiated fixed hourly rates for labor hours incurred plus reimbursement of other allowable costs. Research revenue is recorded in the period in which the associated costs are incurred, up to the limit of the prior approval funding amounts contained in each agreement. The costs associated with these grants are reported as research and development expense.

 

Transactions with Distributors

 

The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the seller’s price is fixed or determinable, and collectability is reasonably assured. The Company’s agreements with distributors do not include rights of return.

 

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Table of Contents

 

Net Income (Loss) Per Share

 

Basic net income (loss) per share is calculated using the weighted-average number of common shares outstanding during the period less the weighted-average shares subject to repurchase. Diluted income (loss) per share gives effect to the dilutive common stock subject to repurchase, stock options and warrants (calculated based on the treasury stock method), and convertible debt (calculated using an as-if-converted method). There are no dilutive warrants and convertible debt in any of the periods presented in the table below.

 

The following table sets forth a reconciliation of basic and diluted net income (loss) per share (in thousands, except per share amounts):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Numerator:

 

 

 

 

 

 

 

 

 

Net (loss) income - basic

 

$

(31,820

)

$

2,580

 

$

10,797

 

$

(183

)

Add effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Interest on convertible notes (inclusive of amortization of debt issuance costs)

 

 

 

 

 

Net (loss) income - diluted

 

$

(31,820

)

$

2,580

 

$

10,797

 

$

(183

)

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding

 

70,249

 

68,935

 

69,682

 

68,607

 

Less: weighted-average shares of common stock subject to repurchase

 

(1,667

)

(579

)

(1,140

)

(437

)

Shares used in computing basic net (loss) income per common share

 

68,582

 

68,356

 

68,542

 

68,170

 

Add effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Employee stock options

 

 

327

 

35

 

 

Common stock subject to repurchase

 

 

42

 

73

 

 

Shares used in computing diluted net (loss) income per common share

 

68,582

 

68,725

 

68,650

 

68,170

 

Basic and diluted net (loss) income per common share

 

$

(0.46

)

$

0.04

 

$

0.16

 

$

(0.00

)

 

 

 

 

 

 

 

 

 

 

Diluted net (loss) income per common share

 

$

(0.46

)

$

0.04

 

$

0.16

 

$

(0.00

)

 

The following securities were excluded from the computation of diluted earnings per common share, on an actual outstanding basis, as they were anti-dilutive (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Employee stock options

 

6,302

 

3,876

 

6,156

 

5,479

 

Restricted stock subject to repurchase

 

1,624

 

96

 

589

 

577

 

Convertible notes

 

14,369

 

3,870

 

14,369

 

3,870

 

Total

 

22,295

 

7,842

 

21,114

 

9,926

 

 

Restructuring

 

The Company has in recent years engaged in, and may continue to engage in, restructuring actions, which require management to utilize significant estimates related to expenses for severance and other employee separation costs, lease cancellation, realizable values of assets that may become duplicative or obsolete, and other exit costs. If the actual amounts differ from the Company’s estimates, the amount of the restructuring charges could be materially impacted. For a full description of the Company’s restructuring actions, see Note 4.

 

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Table of Contents

 

Recent Accounting Pronouncements

 

 In May 2008, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 162, The Hierarchy of Generally Accepted Accounting Principles (“SFAS 162”). SFAS 162 identifies the sources of accounting principles and the framework for selecting the principles used in the preparation of financial statements. SFAS 162 is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, “The Meaning of Present Fairly in Conformity with Generally Accepted Accounting Principles”. The implementation of this standard will not have a material impact on our consolidated financial position and results of operations.

 

In March 2008, the FASB issued SFAS No. 161, Disclosures About Derivative Instruments and Hedging Activities — an amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 expands quarterly disclosure requirements in SFAS No. 133 about an entity’s derivative instruments and hedging activities. SFAS 161 is effective for fiscal years beginning after November 15, 2008. The Company is currently assessing the impact of SFAS 161 on its consolidated results of operations and financial condition.

 

Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements (“SFAS 157”). In February 2008, the FASB issued FASB Staff Position No. FAS 157-2, Effective Date of FASB Statement No. 157, which provides a one year deferral of the effective date of SFAS 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 157 with respect to its financial assets and liabilities only. SFAS 157 defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined under SFAS 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. Valuation techniques used to measure fair value under SFAS 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, that may be used to measure fair value which are the following:

 

·

 

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 adoption of SFAS 157 did not have a material effect on the Company’s financial position, results of operations, or cash flows.

 

In December 2007, the FASB issued SFAS No. 141R, Business Combinations (“SFAS 141R”). SFAS 141R amends SFAS 141 and provides revised guidance for recognizing and measuring identifiable assets and goodwill acquired, liabilities assumed, and any non-controlling interest in the acquiree. It also provides disclosure requirements to enable users of the financial statements to evaluate the nature and financial effects of the business combination. It is effective for fiscal years beginning on or after December 15, 2008 and will be applied prospectively. The Company is currently assessing the impact of SFAS 141R on its consolidated results of operations and financial condition.

 

 In October 2008, the FASB issued FSP 157-3 Determining Fair Value of a Financial Asset in a Market That Is Not Active (FSP 157-3). FSP 157-3 clarified the application of SFAS No. 157 in an inactive market. It demonstrated how the fair value of a financial asset is determined when the market for that financial asset is inactive. FSP 157-3 was effective upon issuance, including prior periods for which financial statements had not been issued. The implementation of this standard did not have a material impact on the Company’s consolidated results of operations and financial condition.

 

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NOTE 2—FAIR VALUE

 

In accordance with SFAS 157,  the following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments) measured at fair value on a recurring basis as of September 30, 2008 (in thousands):

 

 

 

Level 1

 

Level 2

 

Total

 

Non-U.S. equity securities

 

$

894

 

$

 

$

894

 

U.S. government obligations and agencies

 

 

308,024

 

308,024

 

U.S. corporate debt

 

 

120,774

 

120,774

 

Total

 

$

894

 

$

428,798

 

$

429,692

 

 

As of September 30, 2008, the Company had no financial assets or liabilities requiring Level 3 classification.

 

NOTE 3—STOCK-BASED COMPENSATION

 

Stock-Based Compensation Plans

 

The Company has a stock-based compensation program that provides the Board of Directors broad discretion in creating equity incentives for employees, officers, directors and consultants. This program includes incentive and non-qualified stock options and non-vested stock awards (also known as restricted stock) granted under various stock plans. Stock options are generally time-based, vesting 25% on each annual anniversary of the grant date over four years and expire 7 to 10 years from the grant date. Non-vested stock awards are generally time-based, vesting 25% on each annual anniversary of the grant date over four years. On June 11, 2008, at the annual shareholders’ meeting, the shareholders’ approved the amendment to increase the maximum number of shares of the Company’s common stock authorized for issuance under the Company’s Amended and Restated 2000 Equity Incentive Plan by 4.2 million shares. As of September 30, 2008, the Company had approximately 3.3 million shares of common stock reserved for future issuance under its stock-based compensation plans. New shares are issued as a result of stock option exercises and non-vested restricted stock awards.

 

The Company allocated stock-based compensation expense under SFAS No. 123R, Share-Based Payment, as follows (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Costs of product sales

 

$

498

 

$

229

 

$

1,086

 

$

775

 

Research and development

 

625

 

417

 

1,489

 

1,578

 

Selling, general and administrative

 

2,229

 

2,306

 

4,044

 

5,208

 

Restructuring

 

 

340

 

 

340

 

Total stock-based compensation expense

 

3,352

 

3,292

 

6,619

 

7,901

 

Income tax benefit

 

 

(635

)

(871

)

(2,095

)

Total stock-based compensation expense, net of tax

 

$

3,352

 

$

2,657

 

$

5,748

 

$

5,806

 

 

As of September 30, 2008, $38.1 million of total unrecognized stock-based compensation expense related to non-vested awards is expected to be recognized over the respective vesting terms of each award through 2012. The weighted average term of the unrecognized stock-based compensation expense is 3.1 years.

 

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Stock Option Assumptions

 

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

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Risk free interest rate

 

3.0

%

4.2

%

3.2

%

4.2

%

Expected dividend yield

 

0.0

%

0.0

%

0.0

%

0.0

%

Expected volatility

 

42

%

42

%

42

%

42

%

Expected option term (in years)

 

4.5

 

4.5

 

4.5

 

4.5

 

 

The risk free interest rate for periods within the contractual life of the Company’s stock options is based on the U.S. Treasury yield curve in effect at the time of grant. The expected term is derived from an analysis of the Company’s historical exercise trends over ten years. The expected volatility is based on a blend of historical and market-based implied volatility. Using the assumptions above, the weighted average grant date fair value of options granted during the three months ended September 30, 2008 and 2007 was $3.51 and $9.90, respectively, and for the nine months ended September 30, 2008 and 2007 was $4.55 and $9.90, respectively.

 

NOTE 4—RESTRUCTURING

 

Fiscal 2008 Restructuring Plan

 

In February 2008, the Company committed to a restructuring plan (the “2008 Plan”) designed primarily to optimize its production capacity and cost structure and improve its future gross margins.  The restructuring plan was approved as part of the Company’s ongoing efforts to reduce costs.

 

This phase of the restructuring plan involves moving the majority of the Company’s probe array manufacturing from its West Sacramento, California facility to its Singapore facility by the end of 2008.  The Company estimates the total restructuring expenses to be incurred in connection with this phase of the 2008 Plan will be approximately $14.0 million. Of this total, approximately $1.5 million relates to employee severance and $12.5 million relates to non-cash charges associated with the abandonment of certain long-lived manufacturing assets.

 

In July 2008, the Company decided to expand the 2008 Plan to include the closing of its West Sacramento manufacturing facility.  Following the closure of its West Sacramento manufacturing facility, all of its products will be manufactured at its Singapore and Ohio facilities, as well as by third parties. The Company expects the closure of the West Sacramento facility to be substantially complete by the end of the second quarter of 2009.  In this phase of the 2008 Plan, the Company currently expects to incur a total of approximately $36 million in charges related to this expansion of its restructuring plan.  Of this total, the Company expects that approximately $18 million will be included as a component of total cost of product sales, $12 million of which relates to accelerated depreciation charges associated with the continued use of certain long-lived manufacturing assets and $6 million of which relates to manufacturing transition and other costs.  Additionally, the Company expects to recognize approximately $18 million in the line item labeled as “Restructuring charges” in its Condensed Consolidated Statements of Operations, $14 million of which relates to asset impairment charges associated with the facility itself and to certain long-lived manufacturing assets and $4 million related to employee severance costs. In accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities (“SFAS 146”), the costs relating to employee severance and relocation are being recognized as expense over the remaining service periods of the employees.

 

The estimated cash outlays to be incurred in connection with the 2008 Plan are estimated to be approximately $12.5 million.  Depending on the rate at which the Company transfers its production capacity out of its West Sacramento facility, the Company may incur additional expenses. During the first nine months of 2008, the Company recognized approximately $2.9 million of expense for employee termination benefits associated with the 2008 Plan and $25.8 million of non-cash charges related to the abandonment and impairment of certain manufacturing assets. These expenses are presented as a component of “Restructuring charges” in the Company’s Condensed Consolidated Statements of Operations.

 

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Fiscal 2007 Restructuring Plan

 

In July 2007, the Company announced that it was consolidating an administrative facility located in Sunnyvale, California into its main campus in Santa Clara, California during the fourth quarter of 2007 (the “2007 Plan”). Additionally, in August and December 2007, the Company terminated certain employees in the research and development and selling, general and administrative functions. The Sunnyvale, California facility was vacated during the fourth quarter of 2007. The estimated cash outlays to be incurred in connection with these restructuring activities are estimated to be approximately $5 million. During the nine months ended September 30, 2008, the Company recognized approximately $0.4 million related to contract termination costs associated with the 2007 Plan.

 

Fiscal 2006 Restructuring Plan

 

In 2006, the Company initiated a restructuring plan (the “2006 Plan”) to better align certain of its expenses with the Company’s current business outlook. The Company’s primary focus of the 2006 Plan was in the general and administrative functions and included rationalizing its facilities. Cash outlays incurred in connection with these restructuring activities are estimated to be approximately $16 million. During the nine months ended September 30, 2008, the amount of expense recognized associated with the 2006 Plan was not material.

 
The activity for the restructuring plans above for the nine months ended September 30, 2008 and estimated costs for the amounts expected to be recognized as “Restructuring charges” in the Company’s Condensed Consolidated Statements of Operations is as follows (in thousands):
 

 

 

 

 

 

 

 

 

 

 

 

 

As of

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30, 2008

 

 

 

Balance as of

 

 

 

 

 

 

 

 

 

Total

 

Total

 

 

 

December 31,

 

2008

 

Cash

 

Non-Cash

 

Balance as of

 

costs

 

expected

 

 

 

2007

 

Charges

 

Payments

 

Settlements

 

2008

 

to date

 

costs

 

Fiscal 2008 Restructuring Plan:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee severance and relocation benefits

 

$

 

$

2,857

 

$

(1,450

)

$

(179

)

$

1,228

 

$

2,857

 

$

5,800

 

Abandonment and impairment of certain long-lived manufacturing assets

 

 

25,797

 

 

(25,797

)

 

25,797

 

26,000

 

Fiscal 2007 Restructuring Plan:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee severance and relocation benefits

 

1,295

 

 

(1,295

)

 

 

2,887

 

3,000

 

Contract termination costs

 

1,122

 

380

 

(870

)

(7

)

625

 

1,596

 

1,700

 

Other restructuring costs

 

 

 

 

 

 

114

 

200

 

Fiscal 2006 Restructuring Plan:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee severance and relocation benefits

 

140

 

(46

)

(94

)

 

 

20,196

 

20,200

 

Contract termination costs

 

1,761

 

184

 

(762

)

111

 

1,294

 

2,575

 

2,900

 

Other restructuring costs

 

 

207

 

(207

)

 

 

2,195

 

2,200

 

Total

 

$

4,318

 

$

29,379

 

$

(4,678

)

$

(25,872

)

$

3,147

 

$

58,217

 

$

62,000

 

 

NOTE 5—ACQUISITIONS
 

USB Corporation

 

On January 30, 2008, the Company acquired 100% of the outstanding shares of USB Corporation (“USB”), a privately held Cleveland, Ohio-based company that develops, manufactures and markets an extensive line of molecular biology and biochemical reagent products. The acquisition will enable the Company to accelerate the development and commercialization of new genetic analysis solutions and increase the value of its current product portfolio.

 

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Affymetrix accounted for the merger under the purchase method of accounting in accordance with the provisions of SFAS No. 141, Business Combinations (“SFAS 141”). In accordance with SFAS 141, the Company recorded the assets acquired and liabilities assumed at their estimated fair value, with the excess purchase price reflected as goodwill. Additionally, certain costs directly related to the merger were reflected as additional purchase price in excess of net assets acquired. The results of operations of USB have been included in Affymetrix’ consolidated financial statements since January 31, 2008.
 
Purchase Price
 

The total purchase price of the USB acquisition was $72.9 million and includes the following components (in thousands):

 

Merger consideration paid in cash

 

$

70,895

 

Direct acquisition costs

 

1,958

 

Total purchase price

 

$

72,853

 

 

Purchase Price Allocation

 

During the third quarter of 2008, the Company reduced the estimated fair value of the tangible assets, net acquired by $3.1 million due to increasing USB’s inventory reserves to conform to the Company’s inventory reserve methodology, resulting in a corresponding increase of $3.1 million to goodwill. The following table allocates the purchase price based on the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands):

 

Tangible assets, net

 

$

4,003

 

Amortizable intangible assets

 

16,300

 

Goodwill

 

51,750

 

In-process technology

 

800

 

Total

 

$

72,853

 

 

Intangible Assets and Goodwill

 

A valuation of the purchased intangible assets was undertaken by Affymetrix’ management in its determination of the estimated fair value of such assets. The $6.1 million value assigned to developed technology and patents and core technology is included in acquired technology rights on the Company’s Condensed Consolidated Balance Sheet and will be amortized to cost of product sales over the estimated useful lives of these assets, generally four to five years. Affymetrix recorded amortization expense of approximately $0.3 million and $0.9 million for the three and nine months ended September 30, 2008, respectively, related to these acquired patents and technology. The $10.2 million value assigned to customer contracts and trade names and trademarks will be amortized to selling, general and administrative expenses over the estimated useful lives of these assets, generally four to eight years. Affymetrix recorded amortization expense of approximately $0.4 and $1.2 million for the three and nine months ended September 30, 2008, respectively, related to customer contracts and trade names and trademarks. Goodwill of $51.8 million was recorded as the excess of the purchase price over the net assets acquired. Goodwill will not be amortized, but will be assessed for impairment on an annual basis or when an indication of potential impairment exists.

 

In-process Technology

 

Management determined the estimated fair value of certain research and development programs in-process at the acquisition date that had not yet reached technological feasibility and had no alternative future use. These projects primarily included certain molecular biology projects. The fair values of these projects were determined using the Income Approach whereby management estimated each project’s related future net cash flows between 2008 and 2014 and discounted them to their present value using a risk adjusted discount rate of 21%. This discount rate is based on the Company’s estimated weighted average cost of capital adjusted upward for the risks associated with the projects acquired. The projected cash flows from the acquired projects were based on estimates of revenues and operating profits related to the projects considering the stage of development of each potential product acquired, the time and resources needed to complete the development and approval of each product, the life of each potential commercialized product and the inherent difficulties and uncertainties in developing products and services based on complex genetic technologies and biochemical processes. The Company expects cash flows from these projects to begin in 2009 and is not anticipating any material changes to its historical pricing, expense levels or gross margins related to these products.

 

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Table of Contents

 

Escrow Agreement

 

Pursuant to the terms of the USB merger agreement, the Company withheld from the merger consideration $4.0 million and delivered those funds to an escrow account which shall be released to the USB shareholders upon achievement of certain revenue targets in fiscal 2008. Quarterly, the Company must review the revenue targets and to the extent they are achieved, all or a portion of the escrow funds shall be disbursed to the USB shareholders consistent with the terms of the merger agreement. If the prescribed revenue targets are not achieved, some or all of the escrow funds shall be released from restriction. As funds are disbursed to the USB shareholders, the Company will reflect these payments as additional goodwill and will reduce restricted cash. Any funds remaining in escrow at the end of the fiscal year 2008 which are not payable to the USB shareholders and are released from restriction will be reclassified to cash and cash equivalents. As of September 30, 2008, $0.4 million had been disbursed from the escrow account as a result of the achievement of certain revenue targets. Accordingly, $3.6 million is presented as a component of restricted cash in the Company’s Condensed Consolidated Balance Sheet at September 30, 2008.

 

True Materials, Inc.

 

On July 17, 2008, Affymetrix acquired 100% of the outstanding shares of True Materials, Inc. (“TMI”), a privately held San Francisco-based company that develops digitally encoded microparticle technology.  This technology is applicable to the research, applied and diagnostic markets and will enable the Company to enter low to mid-multiplex markets.

 

Affymetrix accounted for the merger under the purchase method of accounting in accordance with the provisions of SFAS No. 141. In accordance with SFAS 141, the Company recorded the assets acquired and liabilities assumed at their estimated fair value, with the excess purchase price reflected as goodwill. Additionally, certain costs directly related to the merger were reflected as additional purchase price in excess of net liabilities assumed. The results of operations have been included in Affymetrix’ consolidated financial statements since July 18, 2008.

 

Purchase Price
 

The total purchase price of the acquisition was $20.4 million and includes the following components (in thousands):

 

Merger consideration paid in cash

 

$

20,160

 

Direct acquisition costs

 

268

 

Total purchase price

 

$

20,428

 

 

Purchase Price Allocation

 

The following table allocates the purchase price based on the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date (in thousands):

 

Goodwill

 

$

16,200

 

In-process technology

 

5,100

 

Net liabilities assumed

 

(872

)

 

 

$

20,428

 

 

In-process Technology

 

Management determined the estimated fair value of certain research and development programs in-process at the acquisition date that had not yet reached technological feasibility and had no alternative future use. These projects primarily included materials research projects. The fair values of these projects were determined using the Income Approach whereby management estimated each project’s related future net cash flows between 2009 and 2015 and discounted them to their present value using a risk adjusted discount rate of 30%. This discount rate is based on the Company’s estimated weighted average cost of capital adjusted upward for the risks associated with the projects acquired. The projected cash flows from the acquired projects were based on estimates of revenues and operating profits related to the projects considering the stage of development of each potential product acquired, the time and resources needed to complete the development and approval of each product, the life of each potential commercialized product and the inherent difficulties and uncertainties in developing products and services based on complex genetic technologies and biochemical processes. The Company expects cash flows from these projects to begin in 2009 and is not anticipating any material changes to its historical pricing, expense levels or gross margins related to these products.

 

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Table of Contents

 

Escrow Agreement

 

Pursuant to the terms of the merger agreement, the Company withheld from the merger consideration $5.1 million and delivered those funds to an escrow account, which shall be released to the founder and certain key employees of TMI upon achievement of certain employment milestones. As the continuous employment milestones are achieved, a portion of the escrow funds shall be disbursed to the founder and certain key employees consistent with the terms of the merger agreement. The Company will record these payments as additional goodwill. As of September 30, 2008, $0.3 million had been disbursed from the escrow account.

 

NOTE 6 —GOODWILL AND OTHER INTANGIBLE ASSETS

 

Goodwill balance is presented below (in thousands):

 

Balance at December 31, 2007

 

$

125,050

 

Goodwill additions

 

67,950

 

Balance at September 30, 2008

 

$

193,000

 

 

During 2008, the Company recorded additional goodwill totaling approximately $68.0 million, of which approximately $51.7 million pertained to the acquisition of USB in the first quarter of fiscal 2008 and approximately $16.2 million pertained to the acquisition of True Materials, Inc. during the third quarter of fiscal year 2008.  As of September 30, 2008, the Company’s goodwill totaled approximately $193.0 million, or 16% of total assets, and its other intangible assets, consisting of net acquired technology rights totaled approximately $54.9 million, or 5% of its total assets (see Note 8).

 

SFAS No. 142, Goodwill and Other Intangible Assets (“SFAS 142”) requires that goodwill be assessed for impairment at least annually or whenever changes in circumstances indicate that the carrying amount may not be recoverable from estimated future cash flows.  Factors that may be considered a change in circumstance indicating the carrying value of our intangible assets, including goodwill, may not be recoverable include, but are not limited to, significant underperformance relative to historical or projected future operating results, a significant decline in our stock price and market capitalization, and negative industry or economic trends.  Additionally, the Company periodically evaluates the recoverability and the amortization period of its acquired technology rights.

 

The Company performed its required annual impairment test in June 2008 and determined that goodwill was not impaired.   During the third quarter of 2008, the Company’s stock price fell below the Company’s net book value per share.  The stock price decline, along with other conditions in the Company’s business, are defined as indicators of impairment of goodwill and other intangibles under SFAS 142Accordingly, the Company was required to assess whether or not an impairment of its intangible assets, including goodwill, had occurred.  The Company performed an impairment test using a market based approach as of September 30, 2008 and determined that there was no impairment.

 

The continued decline of the Company’s stock price subsequent to September 30, 2008 and the resulting book value per share being in excess of market value per share, along with other conditions in its business, are indicators that it is more likely than not that the fair value of the Company is less than the carrying value. Therefore, in the fourth quarter of 2008, the Company will assess whether or not an impairment of its goodwill and other intangible assets has occurred and will be conducting an evaluation of the fair market value of these assets. If the implied fair values of goodwill and other intangible assets are less than the carrying amounts, impairment losses will be recognized for the differences.

 

NOTE 7—INVENTORIES

 

Inventories consist of the following (in thousands):

 

 

 

September 30,

 

December 31,

 

 

 

2008

 

2007

 

Raw materials

 

$

20,116

 

$

20,507

 

Work-in-process

 

11,577

 

11,297

 

Finished goods

 

14,680

 

11,108

 

Total

 

$

46,373

 

$

42,912

 

 

NOTE 8—ACQUIRED TECHNOLOGY RIGHTS

 

Acquired technology rights are comprised of licenses to technology covered by patents to third parties and are amortized over the expected useful life of the underlying patents, which range from one to fifteen years. Accumulated amortization of these rights amounted to approximately $47.3 million and $39.0 million at September 30, 2008 and December 31, 2007, respectively.

 

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Table of Contents

 

The expected future annual amortization expense of the Company’s acquired technology rights and other intangible assets is as follows (in thousands):

 

 

 

Amortization

 

For the Year Ending December 31,

 

Expense

 

2008, remainder thereof

 

$

2,920

 

2009

 

10,550

 

2010

 

9,780

 

2011

 

9,385

 

2012

 

7,631

 

Thereafter

 

14,593

 

Total

 

$

54,859

 

 

NOTE 9—COMPREHENSIVE INCOME (LOSS)

 

The components of comprehensive income (loss) are as follows (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Net (loss) income

 

$

(31,820

)

$

2,580

 

$

10,797

 

$

(183

)

Foreign currency translation adjustment

 

(342

)

243

 

(46

)

303

 

Unrealized (loss) gain on debt securities

 

(2,034

)

(996

)

(4,228

)

1,488

 

Unrealized hedging contracts gain

 

15

 

 

15

 

 

Comprehensive (loss) income

 

$

(34,181

)

$

1,827

 

$

6,538

 

$

1,608

 

 

NOTE 10—RELATED PARTY TRANSACTIONS

 

Perlegen Sciences, Inc.

 

As of September 30, 2008, the Company, and certain of its affiliates, including the Company’s chief executive officer and members of the board of directors, held approximately 22% ownership interest in Perlegen Sciences, Inc. (“Perlegen”), a privately-held biotechnology company. In addition, two members of Perlegen’s board of directors are also members of the Company’s board of directors.

 

The Company formed Perlegen in October 2000 as a wholly-owned subsidiary and spun it off in March 2001 in a $100 million private equity financing. The Company acquired its initial ownership interest in Perlegen in an arrangement which provides Perlegen rights to use certain of the Company’s intellectual property in its development efforts, and also provides the Company rights to use and commercialize certain data generated by Perlegen in the array field.

 

 The Company accounts for its ownership interest in Perlegen using the equity method as the Company and its affiliates do not control the strategic, operating, investing and financing activities of Perlegen; however, the Company does have significant influence over Perlegen’s operating activities. Further, the Company has no obligations to provide funding to Perlegen nor does it guarantee or otherwise have any obligations related to the liabilities or results of operations of Perlegen or its investors. Through January 2005, the Company’s investment in Perlegen had no cost basis; accordingly, the Company has not recorded its proportionate share of Perlegen’s operating losses in its financial statements since the completion of Perlegen’s initial financing. In February 2005, the Company participated in Perlegen’s Series D preferred stock financing and recorded a $2.0 million investment related to this transaction, which was included in the Company’s balance sheet as a component of other assets. As of June 30, 2005, the Company had reduced the carrying value of its investment to zero through the recording of its proportionate share of Perlegen’s operating losses.

 

In accordance with Financial Accounting Standards Board Interpretation No. 46, Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51 as amended (“FIN 46”), the Company has concluded that Perlegen is a variable interest entity in which the Company holds a variable interest, and that the Company is not the primary beneficiary.

 

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NOTE 11—COMMITMENTS AND CONTINGENCIES

 

Legal Proceedings

 

The Company has been in the past and continues to be a party to litigation which has consumed and may continue to consume substantial financial and managerial resources. This could adversely affect our business, financial condition and results of operations. If the Company is found to have infringed the valid intellectual property rights of third parties in any litigation involving the Company or its collaborative partners, the Company or its collaborative partners could be subject to significant liability for damages, prevented from manufacturing and selling its products, or required to obtain a license from a third party, which may not be available on reasonable terms or at all.

 

The Company expects to devote substantial financial and managerial resources to protect its intellectual property rights and to defend itself against the claims described below.

 

E8 Pharmaceuticals LLC Litigation

 

On July 1, 2008, the Company was named as a defendant in a complaint filed by plaintiffs E8 Pharmaceuticals LLC and Massachusetts Institute of Technology (MIT) in the United States District Court of Massachusetts.  In the complaint, the plaintiffs allege that the Company is infringing upon one patent owned by MIT and licensed to E8 Pharmaceuticals by making and selling the Company’s GeneChip® products to customers and teaching its customers how to use the products.  The plaintiffs seek a permanent injunction enjoining the Company from further infringement, and unspecified monetary damages, including lost profits, enhanced damages pursuant to 35 U.S.C. § 284, costs, attorneys’ fees and other relief as the court deems just and proper.  The Company believes that the plaintiffs’ claims are without merit and will vigorously defend against the claims advanced in the complaint.

 

Shareholder Derivative Lawsuits

 

In 2006, three shareholders of the Company filed purported derivative lawsuits on behalf of the Company, which lawsuits name the Company (as nominal defendant) and several of the Company’s current and former officers and directors, and allege that these officers and directors breached their fiduciary duties and breached other laws by participating in backdating stock options grants. Two of these lawsuits were filed in the United States District Court for the Northern District of California, one on August 30, 2006 and the other on September 13, 2006, and were subsequently consolidated. The third lawsuit was filed in the Superior Court of the State of California on October 20, 2006. The substance of the allegations in these cases is similar, and includes claims against the individual defendants for breach of fiduciary duties, unjust enrichment, and violations of federal securities laws, Generally Accepted Accounting Principles, Section 162(m) of the Internal Revenue Code, and certain state laws in each case in connection with the allegedly backdated options. The plaintiffs seek monetary and equitable relief on behalf of the Company, including damages and disgorgement from the individual defendants, changes in the Company’s corporate governance and internal control procedures, and an award of attorneys’ fees and costs. As previously disclosed in the Company’s Forms 10-K/A for the year ended December 31, 2005, the Company’s decision to restate its consolidated financial statements was based on the results of an internal review of its historical stock option granting practices from January 1, 1997 through May 31, 2006 performed under the direction of the Audit Committee of the Board of Directors. The review did not find any pattern or practice of inappropriately identifying grant dates with hindsight in order to provide “discounted” or “in-the-money” grants. On March 31, 2008, the federal district court presiding over the two consolidated cases issued an order granting in part and denying in part the motion of the Company and the individual defendants to dismiss the amended consolidated shareholder derivative complaint. The court allowed the plaintiffs leave to amend, and the plaintiffs filed a second amended consolidated shareholder derivative complaint on April 18, 2008. The individual defendants filed motions to dismiss the second amended consolidated derivative complaint on May 15, 2008. On October 24, 2008, the Court issued a decision granting in part and denying in part the motions to dismiss, and scheduled a case management conference for December 15, 2008. The case in California Superior Court is currently stayed pending resolution of the consolidated federal cases. The Company does not believe that the claims in these derivative lawsuits have merit and the Company intends to vigorously defend the cases.

 

SEC  Informal Inquiry

 

On September 12, 2006, the Company received written notice from the Securities and Exchange Commission that it was conducting an informal inquiry into the Company’s stock option practices. The Company responded to the request for information and cooperated fully in the informal inquiry. The Company was advised in the SEC’s notice that the SEC’s request should not be construed as an indication by the SEC or its staff that any violations of law have occurred; and nor should the request be considered an adverse reflection upon any person, entity or security.

 

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Enzo Litigation

 

On October 28, 2003, Enzo Life Sciences, Inc., a wholly-owned subsidiary of Enzo Biochem, Inc. (collectively “Enzo”) filed a complaint against the Company that is now pending in the United States District Court for the Southern District of New York for breach of contract, injunctive relief and declaratory judgment. The Enzo complaint relates to a 1998 distributorship agreement with Enzo under which the Company served as a non-exclusive distributor of certain reagent labeling kits supplied by Enzo. In its complaint, Enzo seeks monetary damages and an injunction against the Company from using, manufacturing or selling Enzo products and from inducing collaborators and customers to use Enzo products in violation of the 1998 agreement. Enzo also seeks the transfer of certain Affymetrix patents to Enzo. In connection with its complaint, Enzo provided the Company with a notice of termination of the 1998 agreement effective on November 12, 2003.

 

On November 10, 2003, the Company filed a complaint against Enzo in the United States District Court for the Southern District of New York for declaratory judgment, breach of contract and injunctive relief relating to the 1998 agreement. In its complaint, the Company alleges that Enzo has engaged in a pattern of wrongful conduct against it and other Enzo labeling reagent customers by, among other things, asserting improperly broad rights in its patent portfolio, improperly using the 1998 agreement and distributorship agreements in order to corner the market for non-radioactive labeling reagents, and improperly using the 1998 agreement to claim ownership rights to the Company’s proprietary technology. The Company seeks declarations that it has not breached the 1998 agreement and that nine Enzo patents identified in the 1998 agreement are invalid and/or not infringed by it. The Company also seeks damages and injunctive relief to redress Enzo’s alleged breaches of the 1998 agreement, its alleged tortuous interference with the Company’s business relationships and prospective economic advantage, and its alleged unfair competition. The Company filed a notice of related case stating that its complaint against Enzo is related to the complaints already pending in the Southern District of New York against eight other former Enzo distributors. The U.S. District Court for the Southern District of New York has related the Company’s case. There is no trial date in the actions between Enzo and the Company.

 

The Company believes that the claims set forth in Enzo’s complaint are without merit and has filed the action in the Southern District of New York to protect its interests. However, the Company cannot be sure that it will prevail in these matters. The Company’s failure to successfully defend against these allegations could result in a material adverse effect on its business, financial condition and results of operation.

 

Administrative Litigation and Proceedings

 

The Company’s intellectual property is subject to a number of significant administrative and litigation actions. For example, in Europe and Japan, we expect third parties to oppose significant patents that the Company owns or controls. Currently, third parties, including several of the Company’s competitors, have filed oppositions against several of the Company’s European patents in the European Patent Office and requested reexamination of several of the Company’s patents by the United States Patent & Trademark Office. These proceedings are at various procedural stages and will result in the respective patents being either upheld in their entirety, allowed to issue in amended form in designated countries, or revoked. Further, in the United States, the Company expects that third parties will continue to “copy” the claims of its patents in order to provoke interferences in the United States Patent & Trademark Office. These proceedings could modify or reduce the Company’s patent protection and may cause the Company to incur significant costs and consume substantial managerial resources.

 

NOTE 12—INCOME TAXES

 

The income tax provision for the nine months ended September 30, 2008 differs from the amount computed by applying the 35% U.S. federal statutory rate to the consolidated income before income taxes due to various factors, including the tax impact of non-U.S. operations, non-deductible in-process research and development, and the establishment of a partial valuation allowance against the Company’s U.S. deferred tax assets.

 

For the quarter ended September 30, 2008, the Company recorded a non-cash income tax provision of approximately $6.3 million to establish a valuation allowance to partially reserve the Company’s U.S. gross deferred tax assets as of September 30, 2008. The Company evaluated both positive and negative evidence and determined that there is a need for the valuation allowance during the quarter ended September 30, 2008 due to a revised forecast that lowered projected future taxable income. The Company intends to maintain the valuation allowance until sufficient positive evidence exists to support reversal of the valuation allowance. Management periodically evaluates the realizability of the Company’s net deferred tax assets based upon all available evidence. The realization of net deferred tax assets is dependent on the Company’s ability to generate sufficient future taxable income. The forecasted future taxable income is highly influenced by assumptions regarding the Company’s ability to achieve its forecasted revenue and its ability to effectively manage its

 

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expenses in line with its forecasted revenue. The Company believes realization of the deferred tax assets as of September 30, 2008 is more likely than not based upon future taxable earnings. An additional valuation allowance against deferred tax assets may be necessary if it is more likely than not that all or a portion of the deferred tax assets will not be realized, for example as a result of a change in the Company’s ability to reliably project future taxable income or a reduction in the amount of future taxable income.

 

The Company does not expect any material changes to the estimated amount of liability associated with its uncertain tax positions within the next twelve months. As of September 30, 2008, there have been no material changes to the total amount of unrecognized tax benefits.

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Management’s Discussion and Analysis of Financial Condition and Results of Operations as of September 30, 2008 and for the three and nine month periods ended September 30, 2008 and 2007 should be read in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2007.

 

All statements in this quarterly report that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding our “expectations,” “beliefs,” “hopes,” “intentions,” “strategies” or the like. Such statements are based on our current expectations and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results or business conditions may differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, risks of our ability to achieve and sustain higher levels of revenue, improved gross margins, reduced operating expenses, market acceptance, personnel retention, global economic conditions, fluctuations in overall capital spending in the academic and biotechnology sectors, changes in government funding policies, unpredictable fluctuations in quarterly revenues, uncertainties related to cost and pricing of Affymetrix products, dependence on collaborative partners, uncertainties relating to sole source suppliers, uncertainties relating to FDA, and other regulatory approvals, risks relating to intellectual property of others and the uncertainties of patent protection and litigation.

 

Overview

 

We are engaged in the development, manufacture, sale and service of consumables and systems for genetic analysis in the life sciences and clinical healthcare markets and are recognized as a market leader in creating tools that are advancing our understanding of the molecular basis of life. There are a number of factors that influence the size and development of our industry, including: the availability of genomic sequence data for human and other organisms, technological innovation that increases throughput and lowers the cost of genomic and genetic analysis, the development of new computational techniques to handle and analyze large amounts of genomic data, the availability of government and private funding for basic and disease-related research, the amount of capital and ongoing expenditures allocated to research and development spending by biotechnology, pharmaceutical and diagnostic companies, the application of genomics to new areas including molecular diagnostics, agriculture, human identity and consumer goods, and the availability of genetic markers and signatures of diagnostic value.

 

We have established our GeneChip® system as the platform of choice for acquiring, analyzing and managing complex genetic information. Our integrated GeneChip® platform includes disposable DNA probe arrays (chips) consisting of gene sequences set out in an ordered, high density pattern; certain reagents for use with the probe arrays; a scanner and other instruments used to process the probe arrays; and software to analyze and manage genomic information obtained from the probe arrays. We currently sell our products directly to pharmaceutical, biotechnology, agrichemical, diagnostics and consumer products companies as well as academic research centers, government research laboratories, private foundation laboratories and clinical reference laboratories in North America and Europe. We also sell our products through life science supply specialists acting as authorized distributors in Latin America, India, the Middle East and Asia Pacific regions, including China. The following overview describes a few of the key elements of our strategy to improve our overall business:

 

Develop new products and technology. We believe that the genotyping market will continue to be one of the most attractive growth opportunities in life sciences and that new content and new clinical applications will continue to drive growth. These opportunities include our new cytogenetic applications and our new Drug Metabolizing Enzymes and Transporters (DMET) product which we believe addresses a significant unmet need. We anticipate that these products and technologies will contribute to the growth of our business in 2008 and beyond. Additionally, we have been working on a technology revision cycle that we expect will lead to a new product platform. This new product platform is expected to have a lower cost basis and smaller, higher density and more flexible chip formats that will enable us to reach new customers and generate future growth.

 

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Targeted acquisitions to expand our market opportunities. In addition to continued innovation, we are also pursuing acquisitions to expand our market opportunities. In 2008, we completed two acquisitions. The first was USB, a privately held Cleveland, Ohio-based company that develops, manufactures and markets an extensive line of molecular biology and biochemical reagent products for approximately $73 million in cash. This acquisition is expected to accelerate next-generation reagents that will be used with new products that we have in development. In July 2008, we completed an acquisition of a privately held San Francisco-based company that develops digitally encoded microparticle technology for approximately $25 million in cash.  This technology is applicable to the research, applied, and diagnostic markets and will enable us to enter low to mid-multiplex markets and compete with bead-based platforms.

 

Reducing our overall cost structure. Earlier this year, we committed to a restructuring plan designed to optimize our production capacity and cost structure and improve our future gross margins.  The first phase of this restructuring plan involved moving the majority of our probe array manufacturing from our West Sacramento, California facility to our Singapore facility.  In July 2008, we decided to expand our restructuring plan to include the closure of our West Sacramento manufacturing facility.  Following the closure of our West Sacramento manufacturing facility, all of our products will be manufactured at our Singapore and Ohio facilities, as well as by third parties.

 

We expect to incur additional restructuring charges of approximately $50 million relating to our 2008 restructuring plan to the close our West Sacramento facility. The estimated cash outlays to be incurred in connection with the 2008 Plan are estimated to be approximately $12 million.  In connection with these and our other restructuring activities, we incurred a total restructuring charge of $29 million for the nine months ended September 30, 2008.  Depending on the rate at which we transfer our production capacity out of our West Sacramento facility, we may incur additional expenses.

 

Critical Accounting Policies & Estimates

 

General

 

The following section of Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of certain assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

Certain accounting policies are particularly important to the reporting of our financial position and results of operations and require the application of significant judgment by our management. An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the financial statements.

 

Revenue Recognition

 

We enter into contracts to sell our products and, while the majority of our sales agreements contain standard terms and conditions, there are agreements that contain multiple elements or non-standard terms and conditions. As a result, significant contract interpretation is sometimes required to determine the appropriate accounting, including whether the deliverables specified in a multiple element arrangement should be treated as separate units of accounting for revenue recognition purposes, and if so, how the value of the arrangement should be allocated among the deliverable elements, when and how to recognize revenue for each element, and the period over which revenue should be recognized. We recognize revenue for delivered elements only when the fair values of undelivered elements are known and customer acceptance has occurred. Changes in the allocation of the sales price between delivered to undelivered elements might impact the timing of revenue recognition, but would not change the total revenue recognized on any arrangement.

 

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Accounts Receivable

 

We evaluate the collectibility of our trade receivables based on a combination of factors. We regularly analyze our significant customer accounts, and, when we become aware of a specific customer’s inability to meet its financial obligations to us, such as in the case of bankruptcy filings or deterioration in the customer’s operating results or financial position, we record specific bad debt allowances to reduce the related receivable to the amount we reasonably believe is collectible. We also record allowances for bad debt on a small portion of all other customer balances based on a variety of factors including the length of time the receivables are past due, the financial health of the customer, macroeconomic considerations and historical experience. If circumstances related to specific customers change, our estimates of the recoverability of receivables could be further adjusted.

 

Inventories

 

We enter into inventory purchases and commitments so that we can meet future shipment schedules based on forecasted demand for our products. The business environment in which we operate is subject to rapid changes in technology and customer demand. We perform a detailed assessment of inventory each period, which includes a review of, among other factors, demand requirements, product life cycle and development plans, component cost trends, product pricing, product expiration and quality issues. Based on this analysis, we record adjustments to inventory for potentially excess, obsolete or impaired goods, when appropriate, in order to report inventory at net realizable value. Revisions to our inventory adjustments may be required if actual demand, component costs, supplier arrangements, or product life cycles differ from our estimates.

 

Non-marketable Securities

 

As part of our strategic efforts to gain access to potential new products and technologies, we invest in equity securities of certain private biotechnology companies. Our non-marketable equity securities are carried at cost unless we determine that an impairment that is other than temporary has occurred, in which case we write the investment down to its impaired value. We periodically review our investments for impairment; however, the impairment analysis requires significant judgment in identifying events or circumstances that would likely have significant adverse effect on the fair value of the investment. The analysis may include assessment of the investee’s (i) revenue and earnings trend, (ii) business outlook for its products and technologies, (iii) liquidity position and the rate at which it is using its cash, and (iv) likelihood of obtaining subsequent rounds of financing. If an investee obtains additional funding at a valuation lower than our carrying value, we presume that the investment is other than temporarily impaired. We have experienced impairments in our portfolio due to the decline in equity markets over the past few years. However, we are not able to determine at the present time which specific investments are likely to be impaired in the future, or the extent or timing of the individual impairments.

 

Valuation of Goodwill and Intangible Assets

 

 We review goodwill and intangible assets with indefinite lives for impairment annually and whenever events or changes in circumstances indicate the carrying value of goodwill may not be recoverable in accordance with SFAS No. 142, Goodwill and Other Intangible Assets (“SFAS 142”). Purchased intangible assets with finite useful lives are amortized using the straight-line method over their estimated useful lives and are reviewed for impairment under SFAS No. 144, Accounting for the Impairment of Disposal of Long-Lived Assets (“SFAS 144”). Determining the fair value of a reporting unit is judgmental in nature and involves the use of significant estimates and assumptions. These estimates and assumptions include revenue growth rates and forecasted operating margins used to calculate projected future cash flows, risk-adjusted discount rates, future economic and market conditions and determination of appropriate market comparables. We base our fair value estimates on assumptions we believe to be reasonable. Actual future results may differ from those estimates.

 

We performed our required annual impairment test in June 2008 and determined that goodwill was not impaired.   During the third quarter of 2008, our stock price fell below our net book value per share.  The stock price decline, along with other conditions in our business, are defined as indicators of impairment of goodwill and other intangibles under SFAS 142.  Accordingly, we were required to assess whether or not an impairment of our intangible assets, including goodwill, had occurred.  We performed an impairment test using a market-based approach as of September 30, 2008 and determined that there was no impairment.

 

The continued decline of our stock price subsequent to September 30, 2008 and the resulting book value per share being in excess of market value per share, along with other conditions in our business, are indicators that it is more likely than not that the fair value of the Company is less than the carrying value. Therefore, in the fourth quarter of 2008,we will assess whether or not an impairment of its goodwill and other intangible assets has occurred and will be conducting an evaluation of the fair market value of these assets. If the implied fair values of goodwill and other intangible assets are less than the carrying amounts, impairment losses will be recognized for the differences.

 

Income Taxes

 

Income tax expense is based on pretax financial accounting income.  Under the liability method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.  We must then assess the likelihood that the resulting deferred tax assets will be realized.  To the extent we believe that realization is not more likely than not, we establish a valuation allowance.  Significant estimates are required in determining our provision for income taxes, our deferred tax assets and liabilities, unrecognized tax benefits, and any valuation allowance to be recorded against our net deferred tax asset.  Some of these estimates are based on interpretations of existing tax laws or regulations.  We believe that our estimates are reasonable and that our reserves for income tax related uncertainties are adequate. Various

 

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internal and external factors may have favorable or unfavorable effects on our future effective tax rate.  These factors include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in the valuation of deferred tax assets or liabilities, future level of research and development spending, nondeductible expenses, changes in overall levels and geographical mix of actual and forecast pretax earnings, and ultimate outcomes of income tax audits.

 

Contingencies

 

We are subject to legal proceedings principally related to intellectual property matters. Based on the information available at the balance sheet dates, we assess the likelihood of any adverse judgments or outcomes to these matters, as well as potential ranges of probable losses. If losses are probable and reasonably estimable, we will record a reserve in accordance with SFAS No. 5, Accounting for Contingencies. Any reserves recorded may change in the future due to new developments in each matter.

 

Accounting for Stock-Based Compensation

 

We account for employee stock-based compensation in accordance with SFAS 123R. Under the provisions of SFAS 123R, we estimate the fair value of our employee stock awards at the date of grant using the Black-Scholes option-pricing model, which requires the use of certain subjective assumptions. The most significant of these assumptions are our estimates of the expected term, volatility and forfeiture rates of the awards. The expected stock price volatility assumption was determined using a combination of historical and implied volatility of our common stock.  We determined that blended volatility is more reflective of market conditions and a better indicator of expected volatility than historical volatility. The estimate of these key assumptions is based on historical information and judgment regarding market factors and trends.  As required under the accounting rules, we review our valuation assumptions at each grant date and, as a result, we are likely to change our valuation assumptions used to value employee stock-based awards granted in future periods.

 

SFAS 123R requires that employee stock-based compensation costs be recognized over the requisite service period, or the vesting period, in a manner similar to all other forms of compensation paid to employees. Accordingly, in the nine months ended September 30, 2008, we recognized employee stock-based compensation of approximately $1.1 million in cost of product sales, approximately $1.5 million in research and development expense and approximately $4.0 million in selling, general and administrative expenses. During the nine months ended September 30, 2007, we recognized employee stock-based compensation of $0.8 million in cost of product sales, $1.6 million in research and development expense, $5.2 million in selling, general and administrative expenses and $0.3 million in restructuring charges recognized under SFAS 123R.

 

As of September 30, 2008, approximately $38.1 million of total unrecognized stock-based compensation expense related to non-vested awards is expected to be to be recognized over the respective vesting terms of each award through 2012. The weighted-average term of the unrecognized stock-based compensation expense is 3.1 years.

 

Restructuring

 

 We have recently engaged in, and may continue to engage in, restructuring actions, which require management to utilize significant estimates related to expenses for severance and other employee separation costs, lease cancellations, realizable values of assets that may become duplicative or obsolete, and other exit costs. If the actual amounts differ from our estimates, the amount of the restructuring charges could be materially impacted. For a full description of our restructuring actions, see Note 4 to the Condensed Consolidated Financial Statements in Item 1.

 

Results of Operations

 

The following discussion compares the historical results of operations for the three and nine months ended September 30, 2008 and 2007, respectively.

 

Product Sales

 

The components of product sales are as follows (in thousands, except percentage amounts):

 

 

 

 

 

 

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Consumables

 

$

59,804

 

$

59,064

 

$

740

 

1

%

$

187,420

 

$

174,681

 

$

12,739

 

7

%

Instruments

 

6,148

 

10,663

 

(4,515

)

(42

)

16,360

 

27,940

 

(11,580

)

(41

)

Total product sales

 

$

65,952

 

$

69,727

 

$

(3,775

)

(5

)

$

203,780

 

$

202,621

 

$

1,159

 

1

 

 

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Total product sales decreased in the third quarter of 2008 as compared to the same period in 2007. Consumables, which include probe arrays and reagents, increased primarily due to an increase in unit sales of reagents associated with our acquisition of USB Corporation, which was partially offset by a decrease in unit sales of probe arrays. Instrument sales declined primarily due to a decrease in unit sales of our Probe Array systems and GeneChip® Scanners.

 

 Total product sales increased in the first nine months of 2008 compared to the same period in 2007. Consumables increased primarily due to an increase in unit sales of reagents associated with our acquisition of USB Corporation. The increase in unit sales of reagents was partially offset by decreases in the average selling price of certain of our consumables. In addition, instrument sales declined primarily due to a decrease in unit sales of our Probe Array systems and GeneChip® Scanners. Sales to our pharmaceutical customers have declined in the first nine months of 2008 as compared to 2007, particularly in instrument sales.

 

Consumable sales for the three months ended September 30, 2008 and 2007 include $46,000 and $355,000, respectively, of revenue from Perlegen Sciences Inc. (“Perlegen”), a related party. Consumable sales for the nine months ended September 30, 2008 and 2007 include $0.8 million and $11.5 million, respectively, of revenue from Perlegen.

 

Services (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Services

 

$

6,132

 

$

10,829

 

$

(4,697

)

(43

)%

$

23,557

 

$

31,617

 

$

(8,060

)

(25

)%

 

Total services revenue decreased in the third quarter of 2008 as compared to 2007 primarily due to a decrease of $5.0 million in our genotyping services business because of the variable timing of projects, partially offset by an increase of $0.3 million in instrument service revenue. The decrease in total services revenue for the first nine months of 2008 as compared to 2007 is primarily due to a decrease of $9.5 million in our genotyping services business because of the variable timing of projects, partially offset by an increase of $1.4 million in instrument service revenue.

 

Royalties and Other Revenue (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Royalties and other revenue

 

$

3,105

 

$

14,430

 

$

(11,325

)

(78

)%

$

104,338

 

$

29,490

 

$

74,848

 

254

%

 

Royalties and other revenue decreased in the third quarter of 2008 as compared to 2007 primarily due to higher license and grant revenue recognized in 2007. Royalties and other revenue increased in the nine months ended September 30, 2008 as compared to 2007 primarily due to the recognition of a non-recurring $90 million intellectual property payment received in January 2008, partially offset by higher license and grant revenue recognized in 2007.

 

Product and Services Gross Margins (in thousands, except percentage/point amounts):

 

 

 

Three Months Ended

 

Dollar/Point

 

Nine Months Ended

 

Dollar/Point

 

 

 

September 30,

 

change from

 

September 30,

 

change from

 

 

 

2008

 

2007

 

2007

 

2008

 

2007

 

2007

 

Total gross margin on product sales

 

$

33,605

 

$

41,481

 

$

(7,876

)

$

113,199

 

$

126,504

 

$

(13,305

)

Total gross margin on services

 

341

 

3,521

 

(3,180

)

5,397

 

7,143

 

(1,746

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product gross margin as a percentage of products sales

 

51

%

59

%

(9

)

56

%

62

%

(7

)

Service gross margin as a percentage of services

 

6

%

33

%

(27

)

23

%

23

%

0

 

 

The decrease in product gross margin in the third quarter and first nine months of 2008, as compared to 2007, is primarily due to a charge for accelerated depreciation expense related to the closing of our West Sacramento manufacturing facility and lower average selling prices for certain of our consumable products. These decreases were partially offset by favorable consumable product costs.

 

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Gross margin on product sales for the third quarter of 2008 and 2007 includes $42,000 and $188,000, respectively, of gross margin from Perlegen and $0.4 million and $7.0 million, respectively, for the first nine months of 2008 and 2007.

 

The decrease in services gross margin in the third quarter and first nine months of 2008 as compared to the same period in 2007 was primarily due to lower volumes principally associated with sample acquisition delays and a proportionately higher mix of lower priced control samples.

 

Research and Development Expenses (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Research and development

 

$

20,739

 

$

16,489

 

$

4,250

 

26

%

$

59,098

 

$

55,143

 

$

3,955

 

7

%

 

The increase in research and development expenses in the third quarter and first nine months of 2008, as compared to the same periods in 2007 was primarily due to higher headcount related expenses and increased spending for supplies and outside services.

 

Our research and development costs have increased in the near term and we believe a substantial investment in research and development is essential to a long-term sustainable competitive advantage and critical to expansion into additional markets.

 

Selling, General and Administrative Expenses (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Selling, general and administrative

 

$

28,409

 

$

33,300

 

$

(4,891

)

(15

)%

$

92,782

 

$

102,800

 

$

(10,018

)

(10

)%

 

The decrease in selling, general and administrative expenses for the third quarter of 2008, as compared to the same period in 2007 was primarily due to lower headcount related expenses and lower spending for consulting and other outside services.

 

The decrease in selling, general and administrative expenses for the first nine months of 2008, as compared to the same period in 2007 was primarily due to a decrease in legal expenses, principally as a result of the settlement of the Illumina litigation in January 2008, lower headcount related expenses and lower spending for consulting and other outside services.

 

Acquired-in-process technology (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Acquired in-process technology

 

$

5,100

 

$

 

$

5,100

 

100

%

$

5,900

 

$

 

$

5,900

 

100

%

 

During the third quarter of 2008, we completed the acquisition of True Materials, Inc. which we recorded a charge of approximately $5.1 million to acquired in-process technology. We believe the acquisition will enable us to enter low to mid-multiplex markets. We determined the estimated fair value of certain research and development programs in-process at the acquisition date that had not yet reached technological feasibility and had no alternative future use. The fair values of these projects were determined using the Income Approach whereby we estimated each project’s related future net cash flows between 2009 and 2015 and discounted them to their present value using a risk adjusted discount rate of 30%. This discount rate is based on our estimated weighted average cost of capital adjusted upward for the risks associated with the projects acquired.

 

During the first quarter of 2008, we recorded a charge of approximately $0.8 million to acquired in-process technology upon the January 30, 2008 completion of our acquisition of USB. We believe the acquisition will enable us to accelerate the development and commercialization of new genetic analysis solutions and increase the value of our current product portfolio. We determined the estimated fair value of certain research and development programs in-process at the acquisition date that had not yet reached technological feasibility and had no alternative future use. These projects primarily included certain molecular biology projects. The fair values of these projects were determined using the Income Approach whereby we estimated each project’s related future net cash flows between 2008 and 2014 and discounted them to their present value using a risk adjusted discount rate of 21%. This discount rate is based on our estimated weighted average cost of capital adjusted upward for the risks associated with the projects acquired.

 

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The projected cash flows from the acquired projects were based on estimates of revenues and operating profits related to the projects considering the stage of development of each potential product acquired, the time and resources needed to complete the development and approval of each product, the life of each potential commercialized product and the inherent difficulties and uncertainties in developing products and services based on complex genetic technologies and biochemical processes. We expect cash flows from these projects to begin in 2009 and are not anticipating any material changes to our historical pricing, expense levels or gross margins related to these products.

 

Restructuring charges (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Restructuring

 

$

14,571

 

$

5,737

 

$

8,834

 

154

%

$

29,379

 

$

12,879

 

$

16,500

 

128

%

 

Fiscal 2008 Restructuring Plan

 

In February 2008, we committed to a restructuring plan (the “2008 Plan”) designed primarily to optimize our production capacity and cost structure and improve its future gross margins.  The restructuring plan was approved as part of our ongoing efforts to reduce costs.

 

This phase of the restructuring plan involves moving the majority of our probe array manufacturing from our West Sacramento, California facility to our Singapore facility by the end of 2008.  We estimate the total restructuring expenses to be incurred in connection with this phase of the 2008 Plan will be approximately $14.0 million. Of this total, approximately $1.5 million relates to employee severance and $12.5 million relates to non-cash charges associated with the abandonment of certain long-lived manufacturing assets.

 

In July 2008, we decided to expand the 2008 Plan by closing our West Sacramento manufacturing facility.  Following the closure of our West Sacramento manufacturing facility, all of our products will be manufactured at our Singapore and Ohio facilities, as well as by third parties. We expect to incur a total of approximately $36 million in charges related to this expansion of its restructuring plan.  Of this total, we expect that approximately $18 million will be included as a component of total cost of product sales, $12 million of which relates to accelerated depreciation charges associated with the continued use of certain long-lived manufacturing assets and $6 million of which relates to manufacturing transition and other costs.  Additionally, we expect to include approximately $18 million in the line item labeled “Restructuring charges” in our Condensed Consolidated Statements of Operations, $14 million of which relates to asset impairment charges primarily related to the facility itself and to certain long-lived manufacturing assets and $4 million related to employee severance costs. In accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities (“SFAS 146”), the costs relating to employee severance and relocation are being accrued over the remaining service periods of the employees.

 

We expect the closure of the West Sacramento facility to be substantially complete by the end of the second quarter of 2009.  The estimated cash outlays to be incurred in connection with these restructuring activities are estimated to be approximately $10 million.  Depending on the rate at which we transfer our production capacity out of our West Sacramento facility, we may incur additional expenses.

 

Fiscal 2007 Restructuring Plan

 

In July 2007, we announced that it was consolidating an administrative facility located in Sunnyvale, California into our main campus in Santa Clara, California during the fourth quarter of 2007 (the “2007 Plan”). Additionally, in August and December 2007, we terminated certain employees in the research and development and selling, general and administrative functions. The Sunnyvale, California facility was vacated during the fourth quarter of 2007. The estimated cash outlays to be incurred in connection with these restructuring activities are estimated to be approximately $5 million.

 

Fiscal 2006 Restructuring Plan

 

In 2006, we initiated a restructuring plan (the “2006 Plan”) to better align certain of its expenses with our current business outlook. Our primary focus of the 2006 Plan was in the general and administrative functions and included rationalizing our facilities. Cash outlays to be incurred in connection with these restructuring activities are estimated to be approximately $25 million.

 

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Table of Contents

 

During the three months ended September 30, 2008 and 2007, the amount of expense recognized associated with our restructuring plans was approximately $14.6 million and $5.7 million, respectively. The third quarter 2008 restructuring expenses primarily related to our 2008 Plan and were associated with the abandonment and impairment of certain manufacturing assets. The third quarter 2007 restructuring expenses primarily related to our 2007 Plan and were associated with employee related post-termination benefits and contract termination costs.
 
During the nine months ended September 30, 2008 and 2007, the amount of expense recognized associated with our restructuring plans was approximately $29.4 million and $12.9 million, respectively. For the nine months ended September 30, 2008, the restructuring expenses primarily related to our 2008 Plan and were associated with the abandonment and impairment of certain manufacturing assets. For the nine months ended September 30, 2007, the restructuring expenses primarily related to our 2006 Plan as well as employee related post-termination benefits and contract termination costs associated with our 2007 Plan.
 

Interest Income and Other, Net

 

The components of interest income and other, net, are as follows (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Interest income

 

$

3,442

 

$

3,146

 

$

296

 

9

%

$

11,739

 

$

8,988

 

$

2,751

 

31

%

Realized (loss) gain on equity investments, net

 

(491

)

(3,050

)

2,559

 

84

 

1,219

 

(3,249

)

4,468

 

138

 

Currency (losses) gains, net

 

(1,268

)

348

 

(1,616

)

464

 

(2,154

)

527

 

(2,681

)

509

 

Other

 

(11

)

(153

)

142

 

(93

)

26

 

2,116

 

(2,090

)

(99

)

Total interest income and other, net

 

$

1,672

 

$

291

 

$

1,381

 

475

 

$

10,830

 

$

8,382

 

$

2,448

 

29

 

 

Interest income and other, net increased for the third quarter of 2008 by $1.4 million, as compared to the same period in 2007, primarily due to a loss of $3.0 million on the write-down of a non-marketable investment in 2007, partially offset by currency losses in the third quarter of 2008.

 

Interest income and other, net increased for the first nine months of 2008 as compared to the same period in 2007 primarily due to an increase in interest earned of $2.8 million on our higher average total cash balances and a loss of $3.0 million on the write-down of a non-marketable investment in 2007. This was partially offset by higher currency losses of $2.7 million incurred during the first nine months of 2008.

 

Interest Expense (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Interest expense

 

$

(3,497

)

$

(417

)

$

(3,080

)

739

%

$

(10,634

)

$

(1,246

)

$

(9,388

)

753

%

 

Interest expense increased in the third quarter and first nine months of 2008 as compared to 2007 as we recognized interest expense on our $316.3 million 3.50% senior convertible notes issued in November 2007.

 

Income Tax Provision (Benefit) (in thousands, except percentage amounts):

 

 

 

Three Months Ended

 

Dollar

 

Percentage

 

Nine Months Ended

 

Dollar

 

Percentage

 

 

 

September 30,

 

change from

 

change from

 

September 30,

 

change from

 

change from

 

 

 

2008

 

2007

 

2007

 

2007

 

2008

 

2007

 

2007

 

2007

 

Income tax benefit (provision)

 

$

1,802

 

$

(1,162

)

$

2,964

 

255

%

$

(25,093

)

$

550

 

$

(25,643

)

(4,662

)%

 

The income tax benefit increased approximately $3.0 million in the third quarter of 2008 and the income tax provision increased approximately $25.6 million in the first nine months of 2008. In the third quarter of 2008, the income tax provision differs from the amount computed by applying the federal statutory rate of 35% due to various factors including the tax impact of non-U.S. operations, non-deductible in-process research and development, and the establishment of a partial valuation allowance against our U.S. deferred tax assets.

 

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Table of Contents

 

For the quarter ended September 30, 2008, we recorded a non-cash income tax provision of approximately $6.3 million to establish a valuation allowance to partially reserve our U.S. gross deferred tax assets as of September 30, 2008. We evaluated both positive and negative evidence and determined that there is a need for the valuation allowance during the quarter ended September 30, 2008 due to a revised forecast that lowered projected future taxable income. We intend to maintain the valuation allowance until sufficient positive evidence exists to support reversal of the valuation allowance. Management periodically evaluates the realizability of our net deferred tax assets based upon all available evidence. The realization of net deferred tax assets is dependent on our ability to generate sufficient future taxable income. The forecasted future taxable income is highly influenced by assumptions regarding our ability to achieve the forecasted revenue and our ability to effectively manage the expenses in line with the forecasted revenue. We believe realization of the deferred tax assets as of September 30, 2008 is more likely than not based upon future taxable earnings. An additional valuation allowance against deferred tax assets may be necessary if it is more likely than not that all or a portion of the deferred tax assets will not be realized, for example as a result of a change in our ability to reliably project future taxable income or a reduction in the amount of future taxable income.

 

We do not expect any material changes to the estimated amount of liability associated with our uncertain tax positions within the next twelve months. As of September 30, 2008, there have been no material changes to our total amount of unrecognized tax benefits.

 

Liquidity and Capital Resources

 

Cashflow (in thousands):

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

Net cash provided by operating activities

 

$

98,194

 

$

19,356

 

Net cash used in investing activities

 

(71,606

)

(27,214

)

Net cash (used in) provided by financing activities

 

(35

)

12,227

 

Effect of foreign currency translation on cash and cash equivalents

 

(46

)

304

 

Net increase in cash and cash equivalents

 

$

26,507

 

$

4,673

 

 

Net Cash Provided by Operating Activities

 

Cash provided by operating activities is net (loss) income  adjusted for certain non-cash items and changes in operating assets and liabilities. Cash provided by operating activities in the first nine months of 2008 was primarily comprised of net income of $10.8 million, which included a non-recurring $90.0 million intellectual property payment, depreciation and amortization of $32.7 million and a loss on disposal of property and equipment of $25.9 million. Significant changes in assets and liabilities are as follows:

 

Our total accounts receivable, including Perlegen, was $63.5 million at September 30, 2008, a decrease of $18.5 million from December 31, 2007. The decrease is primarily due to lower sales of consumables and instruments in the third quarter of 2008 as compared to the fourth quarter of 2007.

 

Our inventory balance was $46.4 million at September 30, 2008, an increase of $3.5 million from December 31, 2007. The increase is primarily due to the acquisition of USB’s inventory on January 30, 2008, partially offset by an increase in our inventory reserves of $3.1 million.

 

Our prepaid expenses and other assets balance was $15.7 million at September 30, 2008, a decrease of $2.2 million from December 31, 2007. The decrease is primarily related to the receipt of a non-recurring license fee in our other non-trade receivables.

 

Our deferred tax assets balance was $53.7 million at September 30, 2008 an increase of $6.7 million from December 31, 2007. The increase is primarily due to a temporary timing difference associated with the abandonment of certain long-lived manufacturing assets.

 

Our deferred revenue balance was $21.9 million at September 30, 2008, a decrease of $4.5 million from December 31, 2007. The decrease is primarily due to the payment, and recognition as revenue, of a non-recurring license fee.

 

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Table of Contents

 

Net Cash Used in Investing Activities

 

Our investing activities, other than purchases, sales and maturities of available-for-sale securities, primarily consist of capital expenditures, strategic investments and purchased technology rights.

 

Cash used for capital expenditures was $10.9 million and $23.0 million in the first nine months of 2008 and 2007, respectively. Our capital expenditures in 2008 primarily related to our manufacturing facility in Singapore and network upgrades, including the capitalization of cost related to our new enterprise resource planning system.

 

In 2008, we paid approximately $88.2 million, net of cash acquired, for acquisitions of businesses.

 

Net Cash (Used in) Provided by Financing Activities

 

Our financing activities consist of stock option exercise activity under our employee stock plan. Cash (used in) provided by the issuance of stock under our employee stock plan was ($35,000) and $12.2 million in the first nine months of 2008 and 2007, respectively.

 

Off-Balance Sheet Arrangements and Aggregate Contractual Obligations

 

There have been no other significant changes in our off-balance sheet arrangements and aggregate contractual obligations as compared to the disclosures in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2007.

 

On December 15, 2008, 2013, 2018, 2023 and 2028 the security holders have the option to require us to repurchase our $120.0 million 0.75% Notes at a price equal to 100% of the principal amount of the 0.75% Notes plus accrued and unpaid interest. Additionally, on or after December 15, 2008, we have the option of redeeming for cash at 100% of the principal amount all or part of the then outstanding 0.75% Notes plus accrued but unpaid interest.

 

We anticipate that our existing capital resources along with the cash to be generated from operations will enable us to maintain currently planned operations and planned capital expenditures for the foreseeable future, including the potential repayment of our 0.75% Notes.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Foreign Currency Exchange Rate Risk

 

We derive a portion of our revenues in foreign currencies, predominantly in Europe and Japan. In addition, a portion of our assets are held in nonfunctional currencies of our subsidiaries. We use currency forward contracts to manage a portion of the currency exposures created from our activities denominated in foreign currencies. Our hedging program is designed to reduce, but does not entirely eliminate, the impact of currency exchange rate movements.

 

There have been no other significant changes in our market risk compared to the disclosures in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2007.

 

ITEM 4. CONTROLS AND PROCEDURES

 

(a) Disclosure controls and procedures.

 

Affymetrix’s management carried out an evaluation, as required by Rule 13a-15(b) of the Securities Exchange Act of 1934  (the “Exchange Act”), with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as of the end of our last fiscal quarter. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) were effective as of the end of the period covered by this Quarterly Report on Form 10-Q, such that the information relating to Affymetrix and its consolidated subsidiaries required to be disclosed in our Exchange Act reports filed with the SEC (i) is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and (ii) is accumulated and communicated to Affymetrix’s management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

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Table of Contents

 

(b) Changes in internal control over financial reporting.

 

Affymetrix’s management carried out an evaluation, as required by Rule 13a-15(d) of the Exchange Act, with the participation of our Chief Executive Officer and our Chief Financial Officer, of changes in Affymetrix’s internal control over financial reporting. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that there were no changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Information pertaining to legal proceedings can be found in “Item 1. Condensed Consolidated Financial Statements — Note 11. Commitments and Contingencies” to the interim condensed consolidated financial statements, and is incorporated by reference herein.

 

ITEM 1A. RISK FACTORS

 

In evaluating our business, you should carefully consider the following risks, as well as the other information contained in this quarterly report on Form 10-Q. If any of the following risks actually occurs, our business could be harmed.

 

We may not maintain profitability.

 

Although we were profitable for the year ended December 31, 2007, we incurred losses each year from our inception through the year ended December 31, 2002 and also for the year ended December 31, 2006. As a result, we had an accumulated deficit of approximately $97.7 million at September 30, 2008. We expect to continue experiencing fluctuations in our operating results and cannot assure sustained profitability.

 

If our revenues grow more slowly than we anticipate, or if our operating expenses increase more than we expect or cannot be reduced in the event of lower revenues, our business will be materially and adversely affected.

 

Our business depends on research and development spending levels for pharmaceutical and biotechnology companies and academic and governmental research institutions.

 

We expect that our revenues in the foreseeable future will be derived primarily from products and services provided to a relatively small number of pharmaceutical and biotechnology companies and academic, governmental and other research institutions. Our operating results may fluctuate substantially due to reductions and delays in research and development expenditures by these customers. For example, recent delays and reductions in expenditures by our pharmaceutical customers, as well as governmental and research institutions, had adversely affected our results of operations.

 

Factors that could affect the spending levels of our customers include:

 

·                 weakness in the global economy and changing market conditions that affect our customers;

 

·                 changes in the extent to which the pharmaceutical industry may use genetic information and genetic testing as a methodology for drug discovery and development.

 

·                 changes in government programs that provide funding to companies and research institutions;

 

·                 changes in the regulatory environment affecting life sciences companies and life sciences research; and

 

·                 market-driven pressures on companies to consolidate and reduce costs.

 

Our quarterly results have historically fluctuated significantly and may continue to do so. Failure to meet financial expectations may disappoint securities analysts or investors and result in a decline in our stock price.

 

Our revenues and operating results may fluctuate significantly due in part to factors that are beyond our control and which we cannot predict. The timing of our customers’ orders may fluctuate from quarter to quarter. Historically, we have experienced customer ordering patterns for GeneChip® instrumentation and GeneChip® arrays where the majority of the shipments occur in the last month of the quarter. These ordering patterns may limit management’s ability to accurately forecast our future revenues or product mix. Additionally, license revenue may also be unpredictable and may fluctuate due to the timing of payments of non-recurring licensing fees. Because our expenses are largely fixed in the short to medium term, any material shortfall in revenues will materially reduce our profitability and may cause us to experience losses.

 

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Table of Contents

 

Because of this difficulty in predicting future performance, our operating results may fall below our own expectations and the expectations of securities analysts or investors in some future quarter or quarters. Our failure in the past to meet these expectations has adversely affected the market price of our common stock and may continue to do so.

 

In addition to factors that affect the spending levels of our customers described above, additional factors could cause our operating results to fluctuate, including:

 

·                 competition

 

·                 our inability to produce products in sufficient quantities and with appropriate quality;

 

·                 the frequency of experiments conducted by our customers;

 

·                 our customers’ inventory of GeneChip® products;

 

·                 the receipt of relatively large orders with short lead times; and

 

·                 our customers’ expectations as to how long it takes us to fill future orders.

 

We may be required to record a significant charge to earnings if our goodwill or other identified intangible assets become impaired.

 

Current accounting rules require that goodwill be assessed for impairment at least annually or whenever changes in circumstances indicate that the carrying amount may not be recoverable from estimated future cash flows. Factors that may be considered a change in circumstance indicating the carrying value of our intangible assets, including goodwill, may not be recoverable include, but are not limited to, significant underperformance relative to historical or projected future operating results, a significant decline in our stock price and market capitalization, and negative industry or economic trends. Additionally, we periodically evaluate the recoverability and the amortization period of our acquired technology rights.

 

As of September 30, 2008, our goodwill and net acquired technology rights comprised approximately 21% of our total assets. Subsequent to September 30, 2008, the decline in our stock price led to the market value falling below our net equity value. The decline, along with other conditions in our business, are defined as indicators of impairment of goodwill and other intangibles under Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangibles.  Therefore, we are required to assess whether or not an impairment of our intangible assets has occurred and we will be conducting an evaluation of the fair market value of these and other assets, including our deferred tax assets.  We expect to complete our impairment analysis during the fourth quarter.

 

Although we have not recorded any impairment charges to date as a result of our annual and other periodic evaluations, we cannot assure you that future impairment charges may not occur. If we determine that we need to write-down our intangible assets, including goodwill, to their fair value, we may incur material charges that could harm our results of operations and financial condition.

 

The recent financial crisis could negatively affect our business, results of operations, and financial condition.

 

The recent financial crisis affecting the banking system and financial markets and the going concern threats to investment banks and other financial institutions have resulted in a tightening in the credit markets, a low level of liquidity in many financial markets, and extreme volatility in fixed income, credit and equity markets. There could be a number of follow-on effects from the credit crisis on our business, including insolvency of key suppliers resulting in product delays; inability of customers to obtain credit to finance purchases of our products and/or customer insolvencies; counterparty failures negatively impacting our treasury operations; increased expense or inability to obtain short-term financing of our operations from the issuance of commercial paper; and increased impairments from the inability of investee companies to obtain financing.

 

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Table of Contents

 

We may need to adjust our manufacturing capacity based on business requirements or improvements made to our technological capabilities. There are risks associated with the consolidation of our manufacturing facilities.

 

If demand for our products is reduced or if we implement technologies that increase the density or yields of our wafers, our manufacturing capacity could be under-utilized, and we may be required to record an impairment on our long-lived assets including facilities and equipment, which would increase our expenses. In addition, factory planning decisions may shorten the useful lives of long-lived assets including facilities and equipment, and cause us to accelerate depreciation. These changes in demand for our products, and changes in our customers’ product needs, could have a variety of negative effects on our competitive position and our financial results, and, in certain cases, may reduce our revenue, increase our costs, lower our gross margin percentage or require us to recognize impairments of our assets. In addition, if demand for our products is reduced or we fail to accurately forecast demand, we could be required to write down inventory, which would have a negative impact on our gross margin.

 

We have in the past, and may in the future, adjust our capacity based on business requirements, which may include the rationalization of our facilities, including the abandonment of long-lived manufacturing assets and additional charges related to a reduction in capacity. In February 2008, we implemented a restructuring plan in order to optimize our production capacity and cost structure to enable us to increase our gross margins. In July 2008, we expanded our restructuring plan to include the closure of our West Sacramento, California facility.

 

Under our restructuring plan, we will close our West Sacramento manufacturing facility and consolidate our manufacturing to three locations. In addition, we will outsource the manufacturing of our instruments to one or more third parties. Manufacturing and product quality issues may arise as we implement this transition process and increase our production rates and launch new products in our Singapore and Cleveland, Ohio facilities. We may lose customers if we are unable to manufacture products or if we experience delays in the manufacture of our products as a result of this transition.

 

We may lose customers or experience lost sales if we are unable to manufacture or experience delays in the manufacture of our products, or if we are unable to ensure their proper performance and quality.

 

We produce our GeneChip® products in an innovative and complicated manufacturing process which has the potential for significant variability in manufacturing yields. We have encountered and may in the future encounter difficulties in manufacturing our products and, due to the complexity of our products and our manufacturing process, we may experience delays in the manufacture of our products or fail to ensure their proper performance or quality.

 

We base our manufacturing capabilities on our forecasted product mix for the quarter. If the actual product mix varies significantly from our forecast, we may not be able to fill some orders during that quarter, which could adversely impact our financial results. Difficulties in meeting customer, collaborator and internal demand could also cause us to lose customers or require us to delay new product introductions, which could in turn result in reduced demand for our products.

 

We rely on internal quality control procedures to verify our manufacturing processes. Due to the complexity of our products and manufacturing process, however, it is possible that probe arrays that do not meet all of our performance specifications may not be identified before they are shipped. If our products do not consistently meet our customers’ performance expectations, demand for our products will decline. In addition, we do not maintain any backup manufacturing capabilities for the production of our products. Any interruption in our ability to continue operations at our existing manufacturing facilities could delay our ability to develop or sell our products, which could result in lost revenue and seriously harm our business, financial condition and results of operations.

 

We may not realize the expected benefits of our initiatives to reduce costs across our operations.

 

We are pursuing and may continue to pursue a number of initiatives to reduce costs across our operations. These initiatives include workforce reductions in certain areas and the rationalization of our facilities. In 2007, we implemented workforce reductions in certain areas in Santa Clara, California. In February 2008, we implemented a restructuring plan in order to optimize our production capacity and cost structure to enable us to increase our gross margins. In July 2008, we expanded our restructuring plan to include the closure of our West Sacramento, California facility. We expect the closure of our West Sacramento facility to be substantially complete by the end of the second quarter of 2009. We anticipate that we will incur some level of restructuring charges through the end of 2008 and in 2009 as we continue to implement these initiatives.

 

We may not realize the expected benefits of our current and future initiatives to reduce costs. As a result of these initiatives, we expect to incur restructuring or other charges and we may experience disruptions in our operations, a loss of key personnel and difficulties in delivering products in a timely manner.

 

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We depend on a limited number of suppliers and we will be unable to manufacture our products if shipments from these suppliers are delayed or interrupted.

 

We depend on our suppliers to provide components of our products in required volumes, at appropriate quality and reliability levels, and in compliance with regulatory requirements. Key parts of the GeneChip® product line, including components of our manufacturing equipment and certain raw materials used in the synthesis of probe arrays, are currently available only from a single source or limited sources. This risk is increased by the recent consolidation among our suppliers, including the acquisition of Applied Biosystem by Invitrogen.

 

If supplies from these vendors were delayed or interrupted for any reason, we would not be able to get manufacturing equipment, produce probe arrays, or sell scanners or other components for our GeneChip® products in a timely fashion or in sufficient quantities or under acceptable terms. Furthermore, our business is dependent on our ability to forecast the needs for components and products in the GeneChip® product line and our suppliers’ ability to deliver such components and products in time to meet critical manufacturing and product release schedules. Our business could be adversely affected, for example, if suppliers fail to meet product release schedules, if we experience supply constraints, if we fail to negotiate favorable pricing or if we experience any other interruption or delay in the supply chain which interferes with our ability to manufacture our products or manage our inventory levels.

 

Future acquisitions may disrupt our business and distract our management.

 

We have engaged in acquisitions, including our acquisition of two companies in 2008. We will continue to evaluate future acquisitions that we believe to be of strategic importance. Future acquisitions could involve the use of a material portion of our existing cash balance and could limit other potential uses of our cash. If we incur indebtedness in connection with our acquisitions, we may significantly increase our interest expense. To the extent we issue a significant amount of equity securities in connection with future acquisitions, existing stockholders would be diluted.

 

We may not be able to successfully integrate an acquired business into our existing business or an acquired product into our existing product offerings in a timely and non-disruptive manner, or at all, and we could fail to commercialize an acquired technology. Furthermore, an acquisition may not produce the revenues, cost savings, earnings or business synergies that we anticipate. Other challenges could include unanticipated incompatibility of corporate cultures, an inability to retain key employees, including key scientists, the diversion of management’s attention from ongoing business concerns, and the potential adverse reaction of customers or other business partners to an acquisition or resulting changes to the combined company’s product and services offerings.

 

Our due diligence process could fail to identify problems, liabilities or other shortcomings or challenges of an acquired business, product or technology, including issues with the associated intellectual property, product quality or accounting practices. Pre-existing liabilities that we assume in connection with an acquisition could be materially larger than we anticipate. We may face litigation or other claims in connection with an acquisition, or we may inherit claims or litigation risk as a result of an acquisition. If a past or future acquisition fails to meet our expectations, we may need to recognize a goodwill impairment charge. The final valuation of purchased assets and liabilities could impact our future operating results, including our gross margins.

 

Our success depends on the continual development of new products and our ability to manage the transition from our older products to new products.

 

We compete in markets that are new, intensely competitive, highly fragmented and rapidly changing. We may not be able to develop new products that serve these rapidly changing markets. In addition, the successful development, manufacture and introduction of our new products is a complicated process and depends on our ability to manufacture enough products in sufficient quantity and at acceptable cost in order to meet customer demand. If we fail to keep pace with emerging technologies or are unable to develop, manufacture and introduce new products, including the development of new assay protocols and training our customers, we will become less competitive, our pricing and margins will decline and our business will suffer.

 

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The continued success of our GeneChip® products will depend on our ability to produce products with smaller feature sizes, our ability to dice the wafer, and create greater information capacity at our current or lower costs. Our failure to successfully manage the transition between our older products and our new products may adversely affect our financial results. As we introduce new or enhanced products, we must successfully manage the transition from older products to minimize disruption in customers’ ordering patterns, avoid excessive levels of older product inventories and provide sufficient supplies of new products to meet customer demands. When we introduce new or enhanced products, we face numerous risks relating to product transitions, including the inability to accurately forecast demand and difficulties in managing different sales and support requirements due to the type or complexity of the new products.

 

We may not be able to deliver acceptable products to our customers due to the rapidly evolving nature of genetic sequence information upon which our products are based.

 

The genetic sequence information upon which we rely to develop and manufacture our products is contained in a variety of public databases throughout the world. These databases are rapidly expanding and evolving. In addition, the accuracy of such databases and resulting genetic research is dependent on various scientific interpretations and it is not expected that global genetic research efforts will result in standardized genetic sequence databases for particular genomes in the near future.

 

Although we have implemented ongoing internal quality control efforts to help ensure the quality and accuracy of our products, the fundamental nature of our products requires us to rely on genetic sequence databases and scientific interpretations which are continuously evolving. As a result, these variables may cause us to develop and manufacture products that incorporate sequence errors or ambiguities. The magnitude and importance of these errors depends on multiple and complex factors that would be considered in determining the appropriate actions required to remedy any inaccuracies. Our inability to timely deliver acceptable products as a result of these factors would likely adversely affect our relationship with customers, and could have a material adverse effect on our business, financial condition and results of operations.

 

We face risks associated with technological obsolescence and emergence of standardized systems for genetic analysis.

 

The RNA/DNA probe array field is undergoing rapid technological changes. New technologies, techniques or products could emerge which might allow the packaging and analysis of genomic information at densities similar to or higher than our microarray technology. Other companies may begin to offer products that are directly competitive with, or are technologically superior, to our products. We cannot assure you that we will be able to maintain our technological advantages over emerging technologies in the future. In addition, although we believe that we are recognized as a market leader in creating systems for genetic analysis in the life sciences, standardization of tools and systems for genetic research is still ongoing and there can be no assurance that our products will emerge as the standard for genetic research. The emergence of competing technologies and systems as market standards for genetic research may result in our products becoming uncompetitive and could cause our business to suffer.

 

If we do not attract and retain key employees, our business could be impaired.

 

To be successful, we must attract and retain qualified scientific, engineering, manufacturing, sales, and management personnel. To expand our research, product development and sales efforts we need additional people skilled in areas such as bioinformatics, organic chemistry, information services, regulatory affairs, manufacturing, sales, marketing and technical support. Competition for these people is intense. If we are unable to hire, train and retain a sufficient number of qualified employees, we will not be able to expand our business or our business could be adversely affected.

 

We also rely on our scientific advisors and consultants to assist us in formulating our research, development and commercialization strategy. All of these individuals are engaged by other employers and have commitments to other entities that may limit their availability to us.

 

We expect to face increasing competition.

 

The markets for our products are characterized by rapidly changing technology, evolving industry standards, changes in customer needs, emerging competition, new product introductions and strong price competition. We expect to face increased competition in the future as existing companies develop new or improved products and as new companies enter the market with new technologies.

 

For example, companies such as Agilent Technologies, Applied Biosystems and Illumina have products for genetic analysis which are directly competitive with our GeneChip® products. In addition, pharmaceutical and biotechnology companies have significant needs for genomic information and may choose to develop or acquire competing technologies to meet these needs.

 

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Many of our current and potential competitors have significantly greater financial, technical, marketing and other resources than we do. In addition, many current and potential competitors have greater name recognition, more extensive customer bases and access to proprietary genetic content.

 

In the molecular diagnostics field, competition will likely come from established diagnostic companies, companies developing and marketing DNA probe tests for genetic and other diseases and other companies conducting research on new technologies to ascertain and analyze genetic information. Further, in the event that we develop new technology and products that compete with existing technology and products of well established companies, there can be no guarantee that the marketplace will readily adopt any such new technology and products that we may introduce in the future.

 

The market for molecular diagnostics products is currently limited and highly competitive, with several large companies already having significant market share. Companies such as Beckman Coulter, Becton Dickinson, bioMérieux, Celera Diagnostics, Johnson & Johnson and Roche Diagnostics have made strategic commitments to diagnostics, have financial and other resources to invest in new technologies, and have substantial intellectual property portfolios, substantial experience in new product development, regulatory expertise, manufacturing capabilities and the distribution channels to deliver products to customers. Established diagnostic companies also have an installed base of instruments in several markets, including clinical and reference laboratories, which are not compatible with the GeneChip® system and could deter acceptance of our products. In addition, these companies have formed alliances with genomics companies which provide them access to genetic information that may be incorporated into their diagnostic tests.

 

Our effective tax rate may vary significantly.

 

Our operations are subject to income and transaction taxes in the United States and in multiple foreign jurisdictions. Significant estimates and judgments are required in determining our worldwide provision for income taxes. Some of these estimates are based on interpretations of existing tax laws or regulations. The ultimate amount of tax liability may be uncertain as a result.

 

Certain jurisdictions have lower tax rates, and the amount of earnings in these jurisdictions may fluctuate. If we do not have profitable operations in these jurisdictions, our tax rate could be adversely impacted. Changes in tax laws and regulatory requirements in the countries in which we operate could have a material impact on our tax provision. To the extent that we are unable to continue to reinvest a substantial portion of our profits in our foreign operations, we may be subject to additional effective income tax rate increases in the future. Tax authorities may challenge the allocation of profits between our subsidiaries and we may not prevail in any such challenge. If we were not to prevail, we could be subject to higher tax rates or double tax.

 

We rely on our ability to project future taxable income to assess the likelihood that our net deferred tax asset will be realized. To the extent we believe that realization is not more likely than not, we establish a valuation allowance. Significant estimates are required in determining any valuation allowance to be recorded against our net deferred tax assets. Changes in the amount of valuation allowance required may adversely impact our financial results of operations.

 

Other factors that could affect our effective tax rate include levels of research and development spending and nondeductible expenses such as stock based compensation or merger related expenditures, and ultimate outcomes of income tax audits.

 

Our success in penetrating emerging market opportunities in molecular diagnostics depends on the efforts of our partners and the ability of our GeneChip® technologies to be used in clinical applications for diagnosing and enabling informed disease management options in the treatment of disease.

 

The clinical applications of GeneChip® technologies for diagnosing and enabling informed disease management options in the treatment of disease is an emerging market opportunity in molecular diagnostics that seeks to improve the effectiveness of health care by collecting information about DNA variation and RNA expression in patients at various times from diagnosis through prognosis and on to the end of therapy. However, there can be no assurances that molecular diagnostic markets will develop as quickly as we expect or reach what we believe is their full potential. Although we believe that there will be clinical applications of our GeneChip® technologies that will be utilized for diagnosing and enabling informed disease management options in the treatment of disease, there can be no certainty of the technical or commercial success our technologies will achieve in such markets.

 

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The molecular diagnostics market is relatively new for us and presents us with new risks and uncertainties. Our success in this area depends to a large extent on our collaborative relationships and the ability of our collaborative partners to successfully market and sell products using our GeneChip® technologies. As a result, we are also dependent on the ability of our collaborative partners to achieve regulatory approval for such products in the United States and in overseas markets. Although Roche received FDA approval of the first diagnostic genotyping test for use with our GeneChip® System 3000Dx in late 2004, there can be no assurance that other products using our GeneChip® technologies will achieve required approvals.

 

We may not successfully obtain or retain regulatory approval of any diagnostic or other product or service that we or our collaborative partners develop.

 

The FDA must approve certain in-vitro diagnostic products before they can be marketed in the U.S. Certain in-vitro diagnostic products must also be approved by the regulatory agencies of foreign governments or jurisdictions before the product can be sold outside the U.S. Commercialization of our and our collaborative partners’ in-vitro diagnostic products outside of the research environment that may depend upon successful completion of clinical trials. Clinical development is a long, expensive and uncertain process and we do not know whether we, or any of our collaborative partners, will be permitted to undertake clinical trials of any potential in-vitro diagnostic products. It may take us or our collaborative partners many years to complete any such testing, and failure can occur at any stage. Delays or rejections of potential products may be encountered based on changes in regulatory policy for product approval during the period of product development and regulatory agency review. Moreover, if and when our projects reach clinical trials, we or our collaborative partners may decide to discontinue development of any or all of these projects at any time for commercial, scientific or other reasons. Any of the foregoing matters could have a material adverse effect on our business, financial condition and results of operations.

 

Even where a product is exempted from FDA clearance or approval, the FDA may impose restrictions as to the types of customers to which we can market and sell our products. Such restrictions may materially and adversely affect our business, financial condition and results of operations.

 

Medical device laws and regulations are also in effect in many countries, ranging from comprehensive device approval requirements to requests for product data or certifications. The number and scope of these requirements are increasing. We may not be able to obtain regulatory approvals in such countries or may incur significant costs in obtaining or maintaining our foreign regulatory approvals. In addition, the export by us of certain of our products which have not yet been cleared for domestic commercial distribution may be subject to FDA or other export restrictions.

 

Our diagnostic clinical laboratory is subject to extensive federal and state regulation including the requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA). CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by requiring all laboratories to meet specified standards in the areas of personnel qualification, administration, participation in proficiency testing, patient test management, quality control, quality assurance and inspections. There can be no assurance that regulations under and future administrative interpretations of CLIA will not have an adverse impact on the potential market for our diagnostic clinical laboratory.

 

Healthcare reform and restrictions on reimbursements may limit our returns on molecular diagnostic products that we may develop with our collaborators.

 

We are currently developing diagnostic and therapeutic products with our collaborators. The ability of our collaborators to commercialize such products may depend, in part, on the extent to which reimbursement for the cost of these products will be available under U.S. and foreign regulations that govern reimbursement for clinical testing services by government authorities, private health insurers and other organizations. In the U.S., third-party payer price resistance, the trend towards managed health care and legislative proposals to reform health care or reduce government insurance programs could reduce prices for health care products and services, adversely affect the profits of our customers and collaborative partners and reduce our future royalties.

 

Risks related to handling of hazardous materials and other regulations governing environmental safety

 

Our operations are subject to complex and stringent environmental, health, safety and other governmental laws and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these regulations include, among other things, our use of hazardous and radioactive materials and the generation, transportation and storage of waste. We could discover that we or an acquired business is not in material compliance. Existing laws and regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether retroactively or prospectively, that may have a negative effect on our business and results of operations. It is also impossible to eliminate completely the risk of accidental environmental contamination or injury to individuals. In such an event, we could be liable for any damages that result, which could adversely affect our business.

 

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Our success will require that we establish a strong intellectual property position and that we can defend ourselves against intellectual property claims from others.

 

Maintaining a strong patent position is critical to our business. Litigation on these matters has been prevalent in our industry and we expect that this will continue. Patent law relating to the scope of claims in the technology fields in which we operate is still evolving and the extent of future protection is highly uncertain, so we cannot assure you that the patent rights that we have or may obtain will be valuable. Others have filed, and in the future are likely to file, patent applications that are similar or identical to ours or those of our licensors. To determine the priority of inventions, we will have to participate in interference proceedings declared by the United States Patent and Trademark Office that could result in substantial costs in legal fees and could substantially affect the scope of our patent protection. We cannot assure you that any such patent applications will not have priority over our patent applications. Also, our intellectual property may be subject to significant administrative and litigation proceedings such as opposition proceedings against our patents in Europe, Japan and other jurisdictions. Because of the size and breadth of our patent portfolio we may or may not choose to pursue litigation or interferences against those that have infringed on our patents, or used them without authorization, due to the associated expense and time commitment of monitoring these activities.

 

If we fail to protect or to enforce our intellectual property rights successfully, our competitive position could suffer, which could harm our results of operations. Legal actions to enforce our patent rights can be expensive and may involve the diversion of significant management time. In addition, these legal actions could be unsuccessful and could also result in the invalidation of our patents or a finding that they are unenforceable. For example, we currently are engaged in litigation regarding intellectual property rights with third parties. For additional information concerning intellectual property litigation and administrative proceedings, see Note 11 to the Condensed Consolidated Financial Statements in Item 1, Commitments and Contingencies of this Form 10-Q.

 

In addition to patent protection, we also rely upon copyright and trade secret protection for our confidential and proprietary information. Such measures may not provide adequate protection for our copyrights, trade secrets or other proprietary information. In addition, we cannot assure you that trade secrets and other proprietary information will not be disclosed, or that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to or disclose our trade secrets and other proprietary information. There can also be no assurance that we will be able to effectively protect our copyrights, trade secrets or other proprietary information. If we cannot obtain, maintain or enforce intellectual property rights, our competitors may be able to offer probe array systems similar to our GeneChip® technology.

 

Our success also depends in part on us neither infringing patents or other proprietary rights of third parties nor breaching any licenses that may relate to our technologies and products. We are aware of third-party patents that may relate to our technology. We routinely receive notices claiming infringement from third parties as well as invitations to take licenses under third party patents.

 

There can be no assurance that we will not infringe on these patents or other patents or proprietary rights or that we would be able to obtain a license to such patents or proprietary rights on commercially acceptable terms, if at all.

 

If we are unable to maintain our relationships with collaborative partners, we may have difficulty developing and selling our products and services.

 

We believe that our success in penetrating our target markets depends in part on our ability to develop and maintain collaborative relationships with key companies as well as with key academic researchers. Relying on our collaborative relationships is risky to our future success because:

 

     our partners may develop technologies or components competitive with our GeneChip® products;

 

     our existing collaborations may preclude us from entering into additional future arrangements;

 

               our partners may not obtain regulatory approvals necessary to continue the collaborations in a timely manner;

 

               some of our agreements may terminate prematurely due to disagreements between us and our partners;

 

     our partners may not devote sufficient resources to the development and sale of our products;

 

               our partners may be unable to provide the resources required for us to progress in the collaboration on a timely basis;

 

     our collaborations may be unsuccessful; or

 

               some of our agreements have expired and we may not be able to negotiate future collaborative arrangements on acceptable terms.

 

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The size and structure of our current sales, marketing and technical support organizations may limit our ability to sell our products.

 

Although we have invested significant resources to expand our direct sales force and our technical and support staff, we may not be able to establish a sufficiently sized global sales, marketing or technical support organization to sell, market or support our products globally. To assist our sales and support activities, we have entered into distribution agreements through certain distributors, principally in markets outside of North America and Europe. These and other third parties on whom we rely for sales, marketing and technical support in these geographic areas may decide to develop and sell competitive products or otherwise become our competitors, which could harm our business.

 

Due to the international nature of our business, political or economic changes or other factors could harm our business.

 

A significant amount of our revenue is currently generated from sales outside the United States. Though such transactions are denominated in both U.S. dollars and foreign currencies, our future revenue, gross margin, expenses and financial condition are still affected by such factors as changes in foreign currency exchange rates; unexpected changes in, or impositions of, legislative or regulatory requirements, including export and trade barriers and taxes; longer payment cycles and greater difficulty in accounts receivable collection. We are also subject to general geopolitical risks in connection with international operations, such as political, social and economic instability, potential hostilities and changes in diplomatic and trade relationships. We cannot assure investors that one or more of the foregoing factors will not have a material adverse effect on our business, financial condition and operating results or require us to modify our current business practices.

 

We may be exposed to liability due to product defects.

 

The risk of product liability claims is inherent in the testing, manufacturing, marketing and sale of human diagnostic and therapeutic products. We may seek to acquire additional insurance for clinical liability risks. We may not be able to obtain such insurance or general product liability insurance on acceptable terms or in sufficient amounts. A product liability claim or recall could have a serious adverse effect on our business, financial condition and results of operations.

 

Ethical, legal and social concerns surrounding the use of genetic information could reduce demand for our products.

 

Genetic testing has raised ethical issues regarding privacy and the appropriate uses of the resulting information. For these reasons, governmental authorities may call for limits on or regulation of the use of genetic testing or prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure. Similarly, such concerns may lead individuals to refuse to use genetics tests even if permissible. Any of these scenarios could reduce the potential markets for our molecular diagnostic products, which could have a material adverse effect on our business, financial condition and results of operations.

 

Our strategic equity investments may result in losses.

 

We periodically make strategic equity investments in various publicly traded and non-publicly traded companies with businesses or technologies that may complement our business. The market values of these strategic equity investments may fluctuate due to market conditions and other conditions over which we have no control. Other than temporary declines in the market price and valuations of the securities that we hold in other companies will require us to record losses relative to our ownership interest. This could result in future charges on our earnings and as a result, it is uncertain whether or not we will realize any long term benefits associated with these strategic investments.

 

The market price of our common stock has been volatile.

 

The market price of our common stock is volatile. From October 1, 2007 through September 30, 2008, the volume of our common stock traded from 313,600 to 25,474,600 shares. Moreover, during that period, our common stock traded as low as $7.24 per share and as high as $28.12 per share.

 

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Furthermore, volatility in the stock price of other companies has often led to securities class action litigation against those companies. Any future securities litigation against us could result in substantial costs and divert management’s attention and resources, which could seriously harm our business, financial condition and results of operations.

 

The matters relating to our internal review of our historical stock option granting practices and the restatement of our consolidated financial statements may have a material adverse effect on us.

 

During 2006, we conducted an internal review, performed under the direction of our Audit Committee of the Board of Directors, of our historical stock option granting practices from January 1, 1997 through May 31, 2006. As a result of this review, we restated our consolidated financial statements for the years ended December 31, 2005, 2004 and 2003 to record additional non-cash stock-based compensation expense and the related tax impact resulting from stock options granted during fiscal years 1997 to 1999. We have been, and may in the future be, subject to litigation or other proceedings or actions arising in relation to our historical stock option granting practices and the restatement of our prior period financial statements. For example, three purported derivative lawsuits have been filed against us and several of our current and former officers and directors alleging that the defendants breached their fiduciary duty by backdating stock option grants, as well as violations of federal securities laws in connection with the dissemination of our financial and proxy statements, violations of Generally Accepted Accounting Principles, violations of Section 162(m) of the Internal Revenue Code and violations of state law including violation of the California Corporations Code. In addition, we have received notice from the Securities and Exchange Commission that it is conducting an informal inquiry into our stock option practices and we have received notice from the IRS that it is conducting an employment tax audit for the 2005 and 2006 tax years. Litigation and any potential regulatory proceeding or action may be time consuming, expensive and distracting from the conduct of our business. The adverse resolution of any specific lawsuit or any potential regulatory proceeding or action could have a material adverse effect on our business, financial condition and results of operations.

 

Global credit and financial market conditions could negatively impact the value of our current portfolio of cash equivalents or short-term investments and our ability to meet our financing objectives.

 

Our cash and cash equivalents are maintained in highly liquid investments with remaining maturities of 90 days or less at the time of purchase. Our short-term investments consist primarily of readily marketable debt securities with remaining maturities of more than 90 days at the time of purchase. While as of the date of this filing, we are not aware of any downgrades, material losses, or other significant deterioration in the fair value of our cash equivalents or short-term investments since September 30, 2008, no assurance can be given that further deterioration in conditions of the global credit and financial markets would not negatively impact our current portfolio of cash equivalents or short-term investments or our ability to meet our financing objectives.

 

ITEM 5. OTHER INFORMATION

 

On November 5, 2008, our Board of Directors adopted the Amended and Restated Bylaws of the Company (the “Restated Bylaws”), effective immediately upon adoption. The principal changes effected by the Restated Bylaws include:

 

(a)           expanding the required disclosure for stockholders making proposals or nominations to include, among other things, all ownership interests, hedges, economic incentives and rights to vote any shares of any security of the Company;

 

(b)           providing that electronic transmissions of notices of stockholder meetings and Board meetings and waivers of such notices, and participation by stockholders in stockholders’ meetings and directors in Board meetings via remote communications are permitted;

 

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(c)           providing that the notice period for special meetings of the stockholders is the same as the notice period for all meetings of the stockholders, which is at least 10 but not more than 60 days before the meeting;

 

(d)           providing that the officers shall have some powers and perform such duties as are conferred upon them by the Board from time to time and eliminating prescribed duties set forth in the bylaws;

 

(e)           adding a provision to permit the use of uncertificated shares;

 

(f)            making certain other technical and clarifying amendments to matters of administration and process; and

 

(g)           incorporating prior amendments.

 

The foregoing description of the Restated Bylaws is qualified in its entirety by the copy of the Amended and Restated Bylaws that is filed as Exhibit 3.2 hereto and is incorporated herein by reference.

 

ITEM 6. EXHIBITS

 

Exhibit
Number

 

Description of Document

 

 

 

3.2

 

Amended and Restated By-laws

10.20

(a)

Non Qualified Supplemental Deferred Compensation Plan of Affymetrix, Inc.

10.20

(b)

Non Qualified Supplemental Deferred Compensation Plan Adoption Agreement

10.32

 

Affymetrix, Inc. Change of Control Plan

10.33

 

Offer Letter from the Company to John F. (Rick) Runkel dated October 6, 2008

31.1

 

Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

31.2

 

Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

32.1

 

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002

 

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SIGNATURES

 

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

 

By:

/s/ JOHN C. BATTY

 

Name:

John C. Batty

 

Title:

Executive Vice President and Chief Financial Officer

 

 

 

November 7, 2008

 

 

 

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AFFYMETRIX, INC.

EXHIBIT INDEX

SEPTEMBER 30, 2008

 

Exhibit
Number

 

Description of Document

 

 

 

3.2

 

Amended and Restated By-laws

10.20

(a)

Non Qualified Supplemental Deferred Compensation Plan of Affymetrix, Inc.

10.20

(b)

Non Qualified Supplemental Deferred Compensation Plan Adoption Agreement

10.32

 

Affymetrix, Inc. Change of Control Plan

10.33

 

Offer Letter from the Company to John F. (Rick) Runkel dated October 6, 2008

31.1

 

Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

31.2

 

Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

32.1

 

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002

 

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