10-Q 1 a08-25371_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

 

 

x

 

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

 

 

 

For the quarterly period ended September 30, 2008

 

 

 

or

 

 

 

o

 

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

 

 

 

For the transition period from           to           

 

Commission File Number 000-19119

 

Cephalon, Inc.
(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

23-2484489

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification No.)

 

 

 

41 Moores Road

 

 

P.O. Box 4011

 

 

Frazer, Pennsylvania

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

(610) 344-0200
(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable
(Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report)

 


 

Indicate by check mark whether the registrant (1) has filed all reports 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

(Do not check if a smaller reporting company)

Smaller reporting company o

 

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

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding as of October 31, 2008

Common Stock, par value $.01

 

68,445,603 Shares

 

 

 



Table of Contents

 

TABLE OF CONTENTS

 

Cautionary Note Regarding Forward-Looking Statements

 

ii

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

Item 1.

Consolidated Financial Statements

 

 

 

 

 

 

 

Consolidated Statements of Operations — Three and nine months ended September 30, 2008 and 2007

 

1

 

 

 

 

 

Consolidated Balance Sheets — September 30, 2008 and December 31, 2007

 

2

 

 

 

 

 

Consolidated Statements of Stockholders’ Equity — September 30, 2008

 

3

 

 

 

 

 

Consolidated Statements of Cash Flows — Nine months ended September 30, 2008 and 2007

 

4

 

 

 

 

 

Notes to Consolidated Financial Statements

 

5

 

 

 

 

Item 2.

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

 

19

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

38

 

 

 

 

Item 4.

Controls and Procedures

 

38

 

 

 

 

PART II — OTHER INFORMATION

 

38

 

 

 

 

Item 1.

Legal Proceedings

 

38

 

 

 

 

Item 1A. 

Risk Factors

 

38

 

 

 

 

Item 5.

Other Information

 

52

 

 

 

 

Item 6.

Exhibits

 

53

 

 

 

 

SIGNATURES

 

54

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

In addition to historical facts or statements of current condition, this report and the documents into which this report is and will be incorporated contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements contained in this report or incorporated herein by reference constitute our expectations or forecasts of future events as of the date this report was filed with the Securities and Exchange Commission and are not statements of historical fact. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. In particular, these forward-looking statements include, among others, statements about:

 

·                  our dependence on sales of PROVIGIL® (modafinil) Tablets [C-IV] in the United States and the market prospects and future marketing efforts for PROVIGIL, FENTORA® (fentanyl buccal tablet) [C-II], AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), and TREANDA® (bendamustine hydrochloride);

 

·                  any potential approval of our product candidates, including with respect to any expanded indications for NUVIGIL® (armodafinil) Tablets [C-IV] or FENTORA;

 

·                  our anticipated scientific progress in our research programs and our development of potential pharmaceutical products including our ongoing or planned clinical trials, the timing and costs of such trials and the likelihood or timing of revenues from these products, if any;

 

·                  our ability to adequately protect our technology and enforce our intellectual property rights and the future expiration of patent and/or regulatory exclusivity on certain of our products;

 

·                  our ability to comply fully with the terms of our settlement agreements (including the Corporate Integrity Agreement) with the U.S. Attorney’s Office (“USAO”), the Department of Justice (“DOJ”), the Office of the Inspector General of the Department of Health and Human Services (“OIG”) and other federal government entities, the Offices of the Connecticut and Massachusetts Attorneys General and the states;

 

·                  our ongoing litigation matters, including litigation stemming from the settlement of the PROVIGIL patent litigation and the FENTORA patent infringement lawsuits we have filed against Watson Laboratories, Inc. and Barr Laboratories, Inc.;

 

·                  our future cash flow, our ability to service or repay our existing debt and our ability to raise additional funds, if needed, in light of our current and projected level of operations and general economic conditions; and

 

·                  other statements regarding matters that are not historical facts or statements of current condition.

 

Any or all of our forward-looking statements in this report and in the documents we have referred you to may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Therefore, you should not place undue reliance on any such forward-looking statements. The factors that could cause actual results to differ from those expressed or implied by our forward-looking statements include, among others:

 

·                  the acceptance of our products by physicians and patients in the marketplace, particularly with respect to our recently launched products;

 

·                  our ability to obtain regulatory approvals to sell our product candidates, including any additional future indications for FENTORA and NUVIGIL, and to launch such products or indications successfully;

 

·                  scientific or regulatory setbacks with respect to research programs, clinical trials, manufacturing activities and/or our existing products;

 

·                  the timing and unpredictability of regulatory approvals;

 

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·                  unanticipated cash requirements to support current operations, expand our business or incur capital expenditures;

 

·                  the inability to adequately protect our key intellectual property rights;

 

·                  the loss of key management or scientific personnel;

 

·                  the activities of our competitors in the industry;

 

·                  regulatory, legal or other setbacks or delays with respect to the settlement agreements with the USAO, the DOJ, the OIG and other federal entities, the state settlement agreements and Corporate Integrity Agreement related thereto, the settlement agreements with the Offices of the Connecticut and Massachusetts Attorneys General, our settlements of the PROVIGIL patent litigation and the ongoing litigation related to such settlements and the FENTORA patent infringement lawsuits we have filed against Watson and Barr;

 

·                  unanticipated conversion of our convertible notes by our note holders;

 

·                  market conditions in the biopharmaceutical industry that make raising capital or consummating acquisitions difficult, expensive or both; and

 

·                  enactment of new government laws, regulations, court decisions, regulatory interpretations or other initiatives that are adverse to us or our interests.

 

We do not intend to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. We discuss in more detail the risks that we anticipate in Part II, Item 1A of this report. This discussion is permitted by the Private Securities Litigation Reform Act of 1995.

 

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Table of Contents

 

PART I — FINANCIAL INFORMATION

 

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

 

CEPHALON, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS

 

(In thousands, except per share data)

(Unaudited)

 

 

 

Three months ended

 

Nine months ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

REVENUES:

 

 

 

 

 

 

 

 

 

Sales

 

$

489,664

 

$

428,729

 

$

1,408,603

 

$

1,287,802

 

Other revenues

 

8,818

 

9,692

 

25,813

 

34,865

 

 

 

498,482

 

438,421

 

1,434,416

 

1,322,667

 

 

 

 

 

 

 

 

 

 

 

COSTS AND EXPENSES:

 

 

 

 

 

 

 

 

 

Cost of sales

 

121,477

 

82,258

 

312,711

 

251,970

 

Research and development

 

88,325

 

93,527

 

250,169

 

274,078

 

Selling, general and administrative

 

222,948

 

186,456

 

631,832

 

527,962

 

Settlement reserve

 

7,450

 

369,000

 

7,450

 

425,000

 

Restructuring charges

 

1,497

 

 

6,973

 

 

Acquired in-process research and development

 

 

 

10,000

 

 

 

 

441,697

 

731,241

 

1,219,135

 

1,479,010

 

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) FROM OPERATIONS

 

56,785

 

(292,820

)

215,281

 

(156,343

)

 

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

 

 

 

 

 

 

Interest income

 

4,002

 

8,868

 

15,515

 

23,485

 

Interest expense

 

(8,831

)

(5,660

)

(25,697

)

(15,272

)

Gain on extinguishment of debt

 

 

5,319

 

 

5,319

 

Gain on sale of investment

 

 

 

 

5,791

 

Other income (expense), net

 

(2,284

)

2,493

 

1,488

 

3,747

 

 

 

(7,113

)

11,020

 

(8,694

)

23,070

 

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) BEFORE INCOME TAXES

 

49,672

 

(281,800

)

206,587

 

(133,273

)

 

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE (BENEFIT)

 

(62,371

)

24,963

 

(4,375

)

102,613

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS)

 

$

112,043

 

$

(306,763

)

$

210,962

 

$

(235,886

)

 

 

 

 

 

 

 

 

 

 

BASIC INCOME (LOSS) PER COMMON SHARE

 

$

1.64

 

$

(4.58

)

$

3.11

 

$

(3.55

)

 

 

 

 

 

 

 

 

 

 

DILUTED INCOME (LOSS) PER COMMON SHARE

 

$

1.42

 

$

(4.58

)

$

2.79

 

$

(3.55

)

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

68,118

 

66,931

 

67,855

 

66,398

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – ASSUMING DILUTION

 

78,920

 

66,931

 

75,580

 

66,398

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2008

 

2007

 

ASSETS

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

846,595

 

$

818,669

 

Investments

 

 

7,596

 

Receivables, net

 

350,280

 

276,776

 

Inventory, net

 

115,814

 

99,098

 

Deferred tax assets, net

 

167,368

 

176,619

 

Other current assets

 

108,106

 

43,267

 

Total current assets

 

1,588,163

 

1,422,025

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, net

 

501,575

 

500,396

 

GOODWILL

 

471,127

 

476,515

 

INTANGIBLE ASSETS, net

 

753,286

 

817,828

 

DEFERRED TAX ASSETS, net

 

171,865

 

141,752

 

OTHER ASSETS

 

169,589

 

147,753

 

 

 

$

3,655,605

 

$

3,506,269

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Current portion of long-term debt

 

$

1,023,104

 

$

1,237,169

 

Accounts payable

 

81,323

 

91,437

 

Accrued expenses

 

723,728

 

677,184

 

Total current liabilities

 

1,828,155

 

2,005,790

 

 

 

 

 

 

 

LONG-TERM DEBT

 

2,729

 

3,788

 

DEFERRED TAX LIABILITIES, net

 

72,088

 

56,540

 

OTHER LIABILITIES

 

180,539

 

138,084

 

Total liabilities

 

2,083,511

 

2,204,202

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Preferred stock, $0.01 par value, 5,000,000 shares authorized, 2,500,000 shares issued, and none outstanding

 

 

 

Common stock, $0.01 par value, 400,000,000 and 200,000,000 shares authorized, 71,318,187 and 69,956,790 shares issued, and 68,440,453 and 67,604,187 shares outstanding

 

713

 

700

 

Additional paid-in capital

 

2,050,035

 

1,934,965

 

Treasury stock, at cost, 2,877,734 and 2,352,603 shares

 

(194,782

)

(158,173

)

Accumulated deficit

 

(413,166

)

(624,128

)

Accumulated other comprehensive income

 

129,294

 

148,703

 

Total stockholders’ equity

 

1,572,094

 

1,302,067

 

 

 

$

3,655,605

 

$

3,506,269

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

Other

 

 

 

Comprehensive

 

 

 

Common Stock

 

Paid-in

 

Treasury Stock

 

Accumulated

 

Comprehensive

 

 

 

Income (Loss)

 

Total

 

Shares

 

Amount

 

Capital

 

Shares

 

Amount

 

Deficit

 

Income

 

BALANCE, JANUARY 1, 2008

 

 

 

$

1,302,067

 

69,956,790

 

$

700

 

$

1,934,965

 

2,352,603

 

$

(158,173

)

$

(624,128

)

$

148,703

 

Net income

 

$

210,962

 

210,962

 

 

 

 

 

 

 

 

 

 

 

210,962

 

 

 

Foreign currency translation loss

 

(19,300

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prior service costs and gains on retirement-related plans

 

(101

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized investment losses

 

(8

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

(19,409

)

(19,409

)

 

 

 

 

 

 

 

 

 

 

 

 

(19,409

)

Comprehensive income

 

$

191,553

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon conversion of convertible notes

 

 

 

235

 

528,296

 

5

 

230

 

 

 

 

 

 

 

 

 

Exercise of convertible note hedge associated with conversions of convertible notes

 

 

 

 

 

 

 

 

36,585

 

524,754

 

(36,585

)

 

 

 

 

Stock options exercised

 

 

 

37,185

 

831,851

 

8

 

37,177

 

 

 

 

 

 

 

 

 

Tax benefit from equity compensation

 

 

 

4,141

 

 

 

 

 

4,141

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

32,543

 

1,250

 

 

32,543

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

 

 

(24

)

 

 

 

 

 

 

377

 

(24

)

 

 

 

 

Other

 

 

 

4,394

 

 

 

 

 

4,394

 

 

 

 

 

 

 

 

 

BALANCE, SEPTEMBER 30, 2008

 

 

 

$

1,572,094

 

71,318,187

 

$

713

 

$

2,050,035

 

2,877,734

 

$

(194,782

)

$

(413,166

)

$

129,294

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Nine months ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net income (loss)

 

$

210,962

 

$

(235,886

)

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

 

 

 

 

 

Deferred income tax expense (benefit)

 

(9,409

)

8,750

 

Shortfall tax benefits from stock-based compensation

 

(451

)

(222

)

Depreciation and amortization

 

128,772

 

101,206

 

Stock-based compensation expense

 

32,543

 

34,940

 

Gain on extinguishment of debt

 

 

(5,319

)

Gain on sale of investment

 

 

(5,791

)

Loss on disposals of property and equipment

 

2,740

 

2,873

 

Impairment charges

 

1,164

 

 

Other

 

(396

)

180

 

Changes in operating assets and liabilities:

 

 

 

 

 

Receivables

 

(74,258

)

(26,218

)

Inventory

 

(14,557

)

(1,881

)

Other assets

 

(99,008

)

(28,552

)

Accounts payable and accrued expenses

 

34,526

 

380,776

 

Other liabilities

 

70,149

 

49,465

 

Net cash provided by operating activities

 

282,777

 

274,321

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property and equipment

 

(55,689

)

(70,887

)

Acquisition of intangible assets

 

(25,575

)

(99,152

)

Investment in third party

 

(6,242

)

 

Proceeds from sale of investment in third party

 

 

12,291

 

Sales and maturities of available-for-sale investments

 

7,596

 

28,212

 

Purchases of available-for-sale investments

 

 

(71,398

)

Net cash used for investing activities

 

(79,910

)

(200,934

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from exercises of common stock options

 

37,185

 

74,375

 

Windfall tax benefits from stock-based compensation

 

4,592

 

9,934

 

Acquisition of treasury stock

 

(24

)

(128

)

Payments on and retirements of long-term debt

 

(216,093

)

(2,902

)

Net cash provided by (used for) financing activities

 

(174,340

)

81,279

 

 

 

 

 

 

 

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

 

(601

)

10,804

 

 

 

 

 

 

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

27,926

 

165,470

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

818,669

 

496,512

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

846,595

 

$

661,982

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

Acquisition of treasury stock associated with convertible note hedge

 

36,585

 

 

Conversion of convertible notes into common stock

 

235

 

 

Tax benefit from the purchase of convertible note hedge

 

4,525

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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CEPHALON, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share data)

(Unaudited)

 

1.  BASIS OF PRESENTATION

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America 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 footnote disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. These financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, which includes audited financial statements as of December 31, 2007 and 2006 and for each of the three years in the period ended December 31, 2007. The results of our operations for any interim period are not necessarily indicative of the results of our operations for any other interim period or for a full year.

 

Recent Accounting Pronouncements

 

In September 2006, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157 clarifies the definition of fair value, establishes a framework for measuring fair value and expands the disclosures on fair value measurements.  In February 2008, the FASB issued two final staff positions (“FSP”) amending SFAS 157.  FSP SFAS 157-1 amends SFAS 157 to exclude SFAS No. 13, Accounting for Leases and its related interpretive accounting pronouncements that address leasing transactions.   FSP SFAS 157-2 delays the effective date of SFAS 157 until fiscal years beginning after November 15, 2008 for nonfinancial assets and nonfinancial liabilities that are recognized or disclosed at fair value in the financial statements on a nonrecurring basis.  We adopted SFAS 157 on January 1, 2008, except for the items covered by FSP SFAS 157-2.

 

In October 2008, the FASB issued FASB Staff Position No. FAS 157-3, “Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active” (“FSP FAS 157-3”).  FSP FAS 157-3 clarifies the application of SFAS 157 in a market that is not active and provides an example to illustrate key considerations in determining the fair value of a financial asset when the market for that financial asset is not active.  FSP FAS 157-3 was effective upon issuance, including for prior periods for which financial statements have not been issued.  FSP FAS 157-3 did not impact our financial reporting as we do not hold any such assets.

 

SFAS 157 establishes a three-tier fair value hierarchy, which prioritize the inputs used in measuring fair value as follows:

 

·                  Level 1: Observable inputs such as quoted prices in active markets for identical assets and liabilities;

·                  Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

·                  Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

 

Our available-for-sale securities are reported at fair value on our consolidated balance sheet based on quoted prices in active markets for identical assets (Level 1).  As of September 30, 2008, we have no available-for-sale securities.

 

In November 2007, the Emerging Issues Task Force (“EITF”) reached a final consensus on EITF Issue No. 07-1, “Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property” (“EITF 07-1”).  EITF 07-1 defines collaborative arrangements and establishes accounting and financial statement disclosure requirements for such arrangements.  EITF 07-1 is effective for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years.  Adoption is on a retrospective basis to all prior periods presented for all collaborative arrangements existing as of the effective date.  Cephalon’s current accounting policies are consistent with the accounting under EITF 07-1. Therefore, the accounting for our collaborations will not change. The implementation of EITF 07-1 will result in expanded disclosures for collaborations.

 

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In December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS 141(R)”).  SFAS 141(R) will significantly change the accounting for business combinations in a number of areas including the treatment of contingent consideration, contingencies, acquisition costs, IPR&D and restructuring costs. In addition, under SFAS 141(R), changes in deferred tax asset valuation allowances and acquired income tax uncertainties in a business combination after the measurement period will impact income tax expense.  SFAS 141(R) applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. Early application is not permitted. The effect of SFAS 141(R) on our consolidated financial statements will be dependent on the nature and terms of any business combinations that occur after its effective date.

 

In December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements” (“SFAS 160”).  SFAS 160 amends Accounting Research Bulletin No. 51 to establish accounting and reporting standards for the noncontrolling (minority) interest in a subsidiary and for the deconsolidation of a subsidiary. It clarifies that a noncontrolling interest in a subsidiary is an ownership interest in the consolidated entity that should be reported as equity in the consolidated financial statements and establishes a single method of accounting for changes in a parent’s ownership interest in a subsidiary that do not result in deconsolidation. SFAS 160 is effective for fiscal years beginning on or after December 15, 2008.  We do not expect the adoption of SFAS 160 to have a significant impact on our consolidated financial statements unless a future transaction results in a noncontrolling interest in a subsidiary.

 

In March 2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities” (“SFAS 161”).  The new standard is intended to help investors better understand how derivative instruments and hedging activities affect an entity’s financial position, financial performance and cash flows through enhanced disclosure requirements.  The new standard is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early adoption encouraged.  We do not expect the adoption of SFAS 161 to have a significant impact on our consolidated financial statements as we do not currently have any derivatives within the scope of SFAS 161.

 

In April 2008, the FASB issued FASB Staff Position No. FAS 142-3,Determination of the Useful Life of Intangible Assets” (“FSP FAS 142-3”).  FSP FAS 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FASB Statement No. 142, “Goodwill and Other Intangible Assets”. The FSP is intended to improve the consistency between the useful life of a recognized intangible asset under Statement 142 and the period of expected cash flows used to measure the fair value of the asset under SFAS 141(R) and other U.S. generally accepted accounting principles.  The new standard is effective for financial statements issued for fiscal years and interim periods beginning after December 15, 2008.  We are currently evaluating the impact of FSP FAS 142-3 adoption on our consolidated financial statements.

 

In May 2008, the FASB issued FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion” (“FSP APB 14-1”).  FSP APB 14-1 amends APB Opinion No. 14, “Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants,” requiring issuers of convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) to initially record the convertible debt at a discount based on the entity’s nonconvertible debt borrowing rate and amortize the debt discount over the expected term of the debt facility.  The new standard is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years.  Adoption is on a retrospective basis for all prior periods presented.  Upon adoption on January 1, 2009, based on our preliminary evaluation, our convertible debt liability will decrease by approximately $275 million (with a corresponding increase to equity, net of tax) and our 2009 interest expense for our convertible notes will increase by approximately $44 million.

 

2.  RESTRUCTURING

 

On January 15, 2008, we announced a restructuring plan under which we intend to (i) transition manufacturing activities at our CIMA LABS INC. (“CIMA”) facility in Eden Prairie, Minnesota, to our recently expanded manufacturing facility in Salt Lake City, Utah, and (ii) consolidate at CIMA’s Brooklyn Park, Minnesota, facility certain drug delivery research and development activities currently performed in Salt Lake City. The transition of manufacturing activities and the closure of the Eden Prairie facility are expected to be completed within two to three years.  The consolidation of drug delivery research and development activities at Brooklyn Park is expected to be completed in 2008.  The plan is intended to increase efficiencies in manufacturing and research and development activities, reduce our cost structure and enhance competitiveness.

 

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As a result of this plan, we will incur certain costs associated with exit or disposal activities.  As part of the plan, we estimate that approximately 90 jobs will be eliminated in total, with approximately 170 net jobs eliminated at CIMA and approximately 80 net jobs added in Salt Lake City.

 

The total estimated pre-tax costs of the plan are as follows:

 

Severance costs

 

$

14-16 million

 

Manufacturing and personnel transfer costs

 

$

7- 8 million

 

Total

 

$

21-24 million

 

 

The estimated pre-tax costs of the plan are expected to be recognized in 2008 through 2011 and are included in the United States segment.  In addition to the costs described above, we have started to recognize pre-tax, non-cash accelerated depreciation of plant and equipment at the Eden Prairie facility, which we expect to total approximately $18 million to $22 million.

 

Total charges related to the restructuring plan recognized in the consolidated statement of operations and included in the United States segment are as follows:

 

 

 

Three months
ended
September 30,
2008

 

Nine months
ended
September 30,
2008

 

Severance costs

 

$

1,096

 

$

5,990

 

Manufacturing and personnel transfer costs

 

401

 

983

 

Total restructuring charges

 

$

1,497

 

$

6,973

 

 

Summary of charges and spending related to the restructuring plan:

 

Restructuring reserves as of January 1, 2008

 

$

 

Expenses

 

6,973

 

Payments

 

4,127

 

Restructuring reserves as of September 30, 2008

 

$

2,846

 

 

3.  STOCK-BASED COMPENSATION

 

Total stock-based compensation expense recognized in the consolidated statement of operations is as follows:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Stock option expense

 

$

5,940

 

$

6,393

 

$

19,508

 

$

22,570

 

Restricted stock unit expense

 

4,710

 

3,920

 

13,035

 

12,370

 

Total stock-based compensation expense*

 

$

10,650

 

$

10,313

 

$

32,543

 

$

34,940

 

Total stock-based compensation expense after-tax

 

$

6,853

 

$

6,528

 

$

21,014

 

$

22,117

 

 


* Beginning with the third quarter of 2008, total stock-based compensation is allocated 4% to cost of sales, 38% to research and development and 58% to selling, general and administrative expenses based on the employees’ compensation allocation between these line items. During the first half of 2008 and in 2007, total stock-based compensation expense was recognized equally between research and development and selling, general and administrative expenses based on the employees’ compensation allocation between these line items.

 

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4.  ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT EXPENSE

 

In the first quarter of 2008, we recorded acquired in-process research and development expense of $10.0 million related to our license of technology in the field of oncology that is not yet approved by the U.S. Food and Drug Administration (the “FDA”).

 

5.  INVENTORY, NET

 

Inventory, net consisted of the following:

 

 

 

September 30, 2008

 

 

 

Commercial

 

Pre-approval

 

Total

 

Raw materials

 

$

28,443

 

$

 

$

28,443

 

Work-in-process

 

39,378

 

 

39,378

 

Finished goods

 

47,993

 

 

47,993

 

Total inventory, net

 

$

115,814

 

$

 

$

115,814

 

 

 

 

 

 

 

 

 

Inventory, net included in other assets

 

$

128,857

 

$

 

$

128,857

 

 

 

 

December 31, 2007

 

 

 

Commercial

 

Pre-approval

 

Total

 

Raw materials

 

$

28,395

 

$

 

$

28,395

 

Work-in-process

 

24,053

 

367

 

24,420

 

Finished goods

 

46,283

 

 

46,283

 

Total inventory, net

 

$

98,731

 

$

367

 

$

99,098

 

 

 

 

 

 

 

 

 

Inventory, net included in other assets

 

$

119,978

 

$

 

$

119,978

 

 

We have capitalized inventory costs associated with marketed products and certain products prior to regulatory approval and product launch, based on management’s judgment of probable future commercial use and net realizable value.  At December 31, 2007, we had $0.4 million of capitalized inventory costs related to TREANDA included in inventory.  In March 2008, we secured final FDA approval of TREANDA, which was launched in the United States in April 2008.

 

In June 2007, we secured final FDA approval of NUVIGIL.  We intend to launch NUVIGIL commercially in the second half of 2009 and have included net NUVIGIL inventory balances of $128.9 million and $120.0 million at September 30, 2008 and December 31, 2007, respectively, in other assets, rather than inventory.

 

Over the past few years, we have been developing a manufacturing process for the active pharmaceutical ingredient in NUVIGIL that is more cost effective than our prior process of separating modafinil into armodafinil.  As a result of our plan to manufacture armodafinil in the future using this new process and our decision to launch NUVIGIL in the second half of 2009, we assessed the potential impact of these items on certain of our existing agreements to purchase modafinil.  Under these contracts, we have agreed to purchase minimum amounts of modafinil through 2012, with aggregate purchase commitments totaling $64.4 million as of September 30, 2008.  Based on our third quarter assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.

 

6.  PROPERTY, PLANT and EQUIPMENT

 

On September 18, 2008, our subsidiary Cephalon France SAS informed the French Works Councils of its intention to search for a potential acquiror of the manufacturing facility at Mitry-Mory, France.  We are considering the proposed divestiture due to a reduction of manufacturing activities at the Mitry-Mory manufacturing site.  The proposed divestiture is subject to completion of a formal consultation process with the French Works Councils and employees representatives.

 

As a result of this decision, we reevaluated the remaining carrying value and useful life of the Mitry-Mory assets and reduced the estimated useful life to approximately two years.  During the quarter we have recorded pre-tax, non-cash charges associated with accelerated depreciation of plant and equipment of $3.2 million related to the proposed divestiture

 

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based on the new estimated useful life.  As of September 30, 2008, we had $43.3 million of net property and equipment related to the Mitry-Mory facility included on our balance sheet.

 

7.  GOODWILL

 

Goodwill consisted of the following:

 

 

 

United
States

 

Europe

 

Total

 

December 31, 2007

 

$

266,393

 

$

210,122

 

$

476,515

 

Release of pre-acquisition tax valuation allowance

 

 

(416

)

(416

)

Foreign currency translation adjustment

 

 

(4,972

)

(4,972

)

September 30, 2008

 

$

266,393

 

$

204,734

 

$

471,127

 

 

We completed our annual test of impairment of goodwill as of July 1, 2008 and concluded that goodwill was not impaired.

 

8.  INTANGIBLE ASSETS, NET

 

Intangible assets consisted of the following:

 

 

 

 

 

September 30, 2008

 

December 31, 2007

 

 

 

Estimated
Useful
Lives

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Net
Carrying
Amount

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Net
Carrying
Amount

 

Modafinil developed technology

 

15 years

 

$

99,000

 

$

44,550

 

$

54,450

 

$

99,000

 

$

39,600

 

$

59,400

 

DURASOLV technology

 

14 years

 

70,000

 

20,087

 

49,913

 

70,000

 

16,435

 

53,565

 

ACTIQ marketing rights

 

10-12 years

 

83,454

 

51,773

 

31,681

 

83,454

 

46,183

 

37,271

 

GABITRIL product rights

 

9-15 years

 

107,254

 

60,108

 

47,146

 

107,215

 

54,636

 

52,579

 

TRISENOX product rights

 

8-13 years

 

113,370

 

29,385

 

83,985

 

113,836

 

22,749

 

91,087

 

VIVITROL product rights

 

15 years

 

110,000

 

18,333

 

91,667

 

110,000

 

12,833

 

97,167

 

AMRIX product rights

 

18 years

 

99,332

 

15,658

 

83,674

 

99,257

 

6,204

 

93,053

 

MYOCET trademark

 

20 years

 

181,933

 

25,017

 

156,916

 

194,653

 

19,465

 

175,188

 

Other product rights

 

5-20 years

 

293,275

 

139,421

 

153,854

 

269,956

 

111,438

 

158,518

 

 

 

 

 

$

1,157,618

 

$

404,332

 

$

753,286

 

$

1,147,371

 

$

329,543

 

$

817,828

 

 

Intangible assets are amortized over their estimated useful economic life using the straight line method. Amortization expense was $24.0 million and $22.3 million for the three months ended September 30, 2008 and 2007, respectively, and $77.0 million and $64.2 million for the nine months ended September 30, 2008 and 2007, respectively.  In June 2008, the U.S. Patent and Trademark Office issued a pharmaceutical formulation patent for AMRIX; this patent expires in February 2025.  As a result of this issuance, in June 2008, we increased the estimated useful life of the AMRIX product rights from 5 to 18 years.  In October 2008, we, together with our partner, Eurand NV, received two Paragraph IV certification letters relating to Abbreviated New Drug Applications submitted individually to the FDA by Mylan Pharmaceuticals, Inc. and Barr Laboratories, Inc., each requesting approval to market and sell a generic equivalent of AMRIX, as further described in Note 11.  We do not believe that this has an effect on our useful life of AMRIX at this time.

 

9.  TERMINATION OF CO-PROMOTION AGREEMENT

 

With respect to the marketing of PROVIGIL in the United States, on August 29, 2008, we terminated our co-promotion agreement with Takeda Pharmaceuticals North America, Inc. (“TPNA”) effective November 1, 2008.  As a result of the termination, we will be required under the agreement to make payments to TPNA during the three years following the termination of the agreement (the “Sunset Payments”).  The Sunset Payments will be calculated based on a percentage of royalties to TPNA during the final twelve months of the agreement.  In September 2008, we recorded an accrual of $27.2 million representing the present value of the estimated Sunset Payments due to TPNA.

 

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10. LONG-TERM DEBT

 

Long-term debt consisted of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2008

 

2007

 

2.0% convertible senior subordinated notes due June 1, 2015

 

$

820,000

 

$

820,000

 

Zero Coupon convertible subordinated notes first putable June 2008

 

 

213,564

 

Zero Coupon convertible subordinated notes first putable June 2010

 

199,866

 

199,806

 

Mortgage and building improvement loans

 

1,514

 

2,165

 

Capital lease obligations

 

2,664

 

2,841

 

Other

 

1,789

 

2,581

 

Total debt

 

1,025,833

 

1,240,957

 

Less current portion

 

(1,023,104

)

(1,237,169

)

Total long-term debt

 

$

2,729

 

$

3,788

 

 

During the second quarter of 2008, we delivered a notice of redemption to the holders of our Zero Coupon Notes first putable June 2008 (the “2008 Notes”).  Prior to the redemption date, all but $0.1 million of aggregate principal amount of the 2008 Notes were converted.  Holders who converted their 2008 Notes received from us an aggregate of $213.0 million in cash and 528,110 shares of our common stock, under the terms of the 2008 Notes.  Concurrently with the conversion, we received from Credit Suisse First Boston (“CSFB”) 524,754 shares of our common stock in settlement of the convertible note hedge agreement associated with the 2008 Notes.  The warrant held by CSFB and associated with the 2008 Notes expired without exercise. The $0.1 million of 2008 Notes that were not converted were redeemed by us for cash of $0.1 million.

 

Our convertible notes will be classified as current liabilities and presented in current portion of long-term debt on our consolidated balance sheet if our stock price is above the restricted conversion prices of $56.04 or $67.80 with respect to the 2.0% convertible senior subordinated notes due June 1, 2015 (the “2.0% Notes”) or the Zero Coupon Notes first putable June 2010, respectively, at the balance sheet date. At September 30, 2008 and December 31, 2007, our stock price was $77.49 and $71.76, respectively. Therefore, all of our convertible notes are presented in the current portion of long-term debt on our consolidated balance sheet.

 

On August 15, 2008, we established a $200 million, three-year revolving credit facility with JP Morgan Chase Bank, N.A. and certain other lenders.  The credit facility is available for letters of credit, working capital and general corporate purposes and is guaranteed by certain of our domestic subsidiaries.  The credit agreement contains standard covenants, including but not limited to covenants related to total debt to Consolidated EBITDA (as defined in the credit agreement), senior debt to Consolidated EBITDA, interest expense coverage and limitations on capital expenditures, asset sales, mergers and acquisitions, indebtedness, liens, and transactions with affiliates.  As of the date of this filing, we have not drawn any amounts under the credit facility.

 

In the event that a significant conversion of our convertible notes did occur, we believe that we have the ability to raise sufficient cash to repay the principal amounts due through a combination of utilizing our existing cash on hand, accessing our credit facility, raising money in the capital markets and selling our note hedge instruments for cash.

 

11.  LEGAL PROCEEDINGS

 

PROVIGIL Patent Litigation and Settlements

 

In March 2003, we filed a patent infringement lawsuit against four companies—Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals, Inc., Ranbaxy Laboratories Limited and Barr Laboratories, Inc.—based upon the abbreviated new drug applications (“ANDA”) filed by each of these firms with the FDA seeking approval to market a generic form of modafinil. The lawsuit claimed infringement of our U.S. Patent No. RE37,516 (the “‘516 Patent”) which covers the pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL and which expires on April 6, 2015. We believe that these four companies were the first to file ANDAs with Paragraph IV certifications and thus are eligible for the 180-day period of marketing exclusivity provided by the provisions of the Federal Food, Drug and Cosmetic Act.  In early 2005, we also filed a patent infringement lawsuit against Carlsbad Technology, Inc. based upon the Paragraph IV ANDA related to modafinil that Carlsbad filed with the FDA.

 

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In late 2005 and early 2006, we entered into settlement agreements with each of Teva, Mylan, Ranbaxy and Barr; in August 2006, we entered into a settlement agreement with Carlsbad and its development partner, Watson Pharmaceuticals, Inc., which we understand has the right to commercialize the Carlsbad product if approved by the FDA. As part of these separate settlements, we agreed to grant to each of these parties a non-exclusive royalty-bearing license to market and sell a generic version of PROVIGIL in the United States, effective in April 2012, subject to applicable regulatory considerations. Under the agreements, the licenses could become effective prior to April 2012 only if a generic version of PROVIGIL is sold in the United States prior to this date.

 

We also received rights to certain modafinil-related intellectual property developed by each party and in exchange for these rights, we agreed to make payments to Barr, Ranbaxy and Teva collectively totaling up to $136.0 million, consisting of upfront payments, milestones and royalties on net sales of our modafinil products. In order to maintain an adequate supply of the active drug substance modafinil, we entered into agreements with three modafinil suppliers whereby we have agreed to purchase an annual minimum amount of modafinil over a nine year period that began in 2006, with the aggregate payments over this period totaling approximately $82.6 million.

 

We filed each of the settlements with both the U.S. Federal Trade Commission (the “FTC”) and the Antitrust Division of the U.S. Department of Justice (the “DOJ”) as required by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the “Medicare Modernization Act”). The FTC conducted an investigation of each of the PROVIGIL settlements and, in February 2008, filed suit against us in the U.S. District Court for the District of Columbia challenging the validity of the settlements and related agreements entered into by us with each of Teva, Mylan, Ranbaxy and Barr.  We filed a motion to transfer the case to the U.S. District Court for the Eastern District of Pennsylvania, which was granted in April 2008.  The complaint alleges a violation of Section 5(a) of the Federal Trade Commission Act and seeks to permanently enjoin us from maintaining or enforcing these agreements and from engaging in similar conduct in the future.  We believe the FTC complaint is without merit and we have filed a motion to dismiss the case.  While we intend to vigorously defend ourselves and the propriety of the settlement agreements, these efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

We also are aware of numerous private antitrust complaints filed in the U.S. District Court for the Eastern District of Pennsylvania, each naming Cephalon, Barr, Mylan, Teva and Ranbaxy as co-defendants and claiming, among other things, that the PROVIGIL settlements violate the antitrust laws of the United States and, in some cases, certain state laws.  These actions have been consolidated into a complaint on behalf of a class of direct purchasers of PROVIGIL and a separate complaint on behalf of a class of consumers and other indirect purchasers of PROVIGIL. A separate complaint filed by an indirect purchaser of PROVIGIL was filed in September 2007. The plaintiffs in all of these actions are seeking monetary damages and/or equitable relief. We moved to dismiss the class action complaints in November 2006 and those motions are still pending.

 

Separately, in June 2006, Apotex, Inc., a subsequent ANDA filer seeking FDA approval of a generic form of modafinil, filed suit against us, also in the U.S. District Court for the Eastern District of Pennsylvania, alleging similar violations of antitrust laws and state law. Apotex asserts that the PROVIGIL settlement agreements improperly prevent it from obtaining FDA approval of its ANDA, and seeks monetary and equitable remedies. Apotex also seeks a declaratory judgment that the ‘516 Patent is invalid, unenforceable and/or not infringed by its proposed generic. In late 2006, we filed a motion to dismiss the Apotex case, which is pending.  Separately, in April 2008, the Federal Court of Canada dismissed our application to prevent regulatory approval of Apotex’s generic modafinil tablets in Canada. We have learned that Apotex has launched its generic modafinil tablets in Canada, and we intend to initiate a patent infringement lawsuit against Apotex. We believe that the private antitrust complaints described in the preceding paragraph and the Apotex antitrust complaint are without merit. While we intend to vigorously defend ourselves and the propriety of the settlement agreements, these efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

In November 2005 and March 2006, we received notice that Caraco Pharmaceutical Laboratories, Ltd. and Apotex, respectively, also filed Paragraph IV ANDAs with the FDA in which each firm is seeking to market a generic form of PROVIGIL. We have not filed a patent infringement lawsuit against either Caraco or Apotex as of the filing date of this report, although Apotex has filed suit against us, as described above.  In early August 2008, we received notice that Hikma Pharmaceuticals filed a Paragraph IV ANDA with the FDA in which it is seeking to market a generic form of PROVIGIL. We have not filed a patent infringement lawsuit against Hikma Pharmaceuticals as of the filing date of this report.

 

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U.S. Attorney’s Office and Connecticut Attorney General Investigations and Related Matters

 

In early November 2007, we announced that we had reached an agreement in principle with the U.S. Attorney’s Office (“USAO”) in Philadelphia and the DOJ with respect to the USAO investigation that began in September 2004.  On September 29, 2008, to finalize our previously announced agreement in principle, we entered into a settlement agreement (the “Settlement Agreement”) with the DOJ, the USAO, the Office of Inspector General of the Department of Health and Human Services (“OIG”), TRICARE Management Activity, the U.S. Office of Personnel Management (collectively, the “United States”) and the relators identified in the Settlement Agreement (the “Relators”) to settle the outstanding False Claims Act claims alleging off-label promotion of ACTIQ and PROVIGIL from January 1, 2001 through December 31, 2006 and GABITRIL from January 2, 2001 through February 18, 2005 (the “Claims”). As part of the Settlement Agreement we agreed to pay a total of $375 million (the “Payment”) plus interest of $11.3 million. We also agreed to pay the Relators’ attorneys’ fees.  Pursuant to the Settlement Agreement, the United States and the Relators released us from all Claims and the United States agreed to refrain from seeking our exclusion from Medicare/Medicaid, the TRICARE Program or other federal health care programs.  In connection with the Settlement Agreement, we pled guilty to one misdemeanor violation of the U.S. Food, Drug and Cosmetic Act and agreed to pay $50 million (in addition to the Payment), of which $40 million applied to a criminal fine and $10 million applied to satisfy the forfeiture obligation.

 

As part of the Settlement Agreement, we entered into a five-year Corporate Integrity Agreement (the “CIA”) with the OIG.  The CIA provides criteria for establishing and maintaining compliance.  We are also subject to periodic reporting and certification requirements attesting that the provisions of the CIA are being implemented and followed. We also agreed to enter into a State Settlement and Release Agreement (the “State Settlement Agreement”) with each of the 50 states and the District of Columbia.  Upon entering into the State Settlement Agreement, a state will receive its portion of the Payment allocated for the compensatory state Medicaid payments and related interest amounts.  Each state also agrees to refrain from seeking our exclusion from its Medicaid program.

 

On September 29, 2008, we also announced that we had entered into an Assurance of Voluntary Compliance (the “Connecticut Assurance”) with the Attorney General of the State of Connecticut and the Commissioner of Consumer Protection of the State of Connecticut (collectively, “Connecticut”) to settle Connecticut’s investigation of our promotion of ACTIQ, GABITRIL and PROVIGIL.  Pursuant to the Connecticut Assurance, (i) we agreed to pay a total of $6.15 million to Connecticut, of which $3.8 million will fund Connecticut Department of Public Health cancer initiatives and $0.2 million will fund a state electronic prescription monitoring program; and (ii) Connecticut released us from any claim relating to the promotional practices that were the subject of Connecticut’s investigation.  On the same date we also entered into an Assurance of Discontinuance (the “Massachusetts Settlement Agreement”) with the Attorney General of the Commonwealth of Massachusetts (“Massachusetts”) to settle Massachusetts’ investigation of our  promotional practices with respect to fentanyl-based products.  Pursuant to the Massachusetts Settlement Agreement, (i) we agreed to pay a total of $0.7 million to Massachusetts, of which $0.45 million will fund Massachusetts cancer initiatives and benefit consumers in Massachusetts; and (ii) Massachusetts released us from any claim relating to the promotional practices that were the subject of Massachusetts’ investigation.

 

In late 2007, we were served with a series of putative class action complaints filed on behalf of entities that claim to have purchased ACTIQ for uses outside of the product’s approved label in non-cancer patients.  The complaints allege violations of various state consumer protection laws, as well as the violation of the common law of unjust enrichment, and seek an unspecified amount of money in actual, punitive and/or treble damages, with interest, and/or disgorgement of profits.  In May 2007, the plaintiffs filed a consolidated and amended complaint that also allege violations of RICO and conspiracy to violate RICO.  We believe the allegations in the complaint are without merit, and we intend to vigorously defend ourselves in these matters and in any similar actions that may be filed in the future.  These efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

In March 2007 and March 2008, we received letters requesting information related to ACTIQ and FENTORA from Congressman Henry A. Waxman in his capacity as Chairman of the House Committee on Oversight and Government Reform.  The letters request information concerning our sales, marketing and research practices for ACTIQ and FENTORA, among other things.  We are cooperating with these requests and are continuing to provide documents and other information to the Committee.

 

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FENTORA Patent Litigation

 

In April 2008 and June 2008, we received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Watson Laboratories, Inc. and Barr, respectively, requesting approval to market and sell a generic equivalent of FENTORA.  Both Watson and Barr allege that our U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the product described in their respective ANDAs.  The 6,200,604 and 6,974,590 patents cover methods of use for FENTORA and do not expire until 2019.  In June 2008 and July 2008, we and our wholly-owned subsidiary, CIMA LABS INC., filed lawsuits in U.S. District Court in Delaware against Watson and Barr for infringement of these patents.  Under the provisions of the Hatch-Waxman Act, the filing of these lawsuits stays any FDA approval of each ANDA until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the date of our receipt of the respective Paragraph IV certification letter. We intend to vigorously defend our intellectual property rights.

 

AMRIX

 

In October 2008, we, together with our partner, Eurand NV, received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan and Barr, each requesting approval to market and sell a generic equivalent of AMRIX.  Mylan alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or unenforceability of the Eurand patent.  Barr alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.  The 7,387,793 patent covers extended-release formulations containing cyclobenzaprine and does not expire until February 26, 2025.  Eurand and Cephalon currently are reviewing the respective letters and, by statute, Eurand, as patent holder, has 45 days to initiate a patent infringement lawsuit against Mylan and/or Barr.  Such a lawsuit would automatically prevent the FDA from approving the Mylan ANDA and/or the Barr ANDA, as the case may be, until the earlier of a district court decision or 30 months from our receipt of the applicable letter. Eurand and Cephalon have not filed a patent infringement lawsuit against either Mylan or Barr as of the filing date of this report. Working with Eurand, we intend to vigorously defend the AMRIX intellectual property rights.

 

Derivative Suit

 

In January 2008, a purported stockholder of the company filed a derivative suit on behalf of Cephalon in the U.S. District Court for the District of Delaware naming each member of our Board of Directors as defendants.  The suit alleges, among other things, that the defendants failed to exercise reasonable and prudent supervision over the management practices and controls of Cephalon, including with respect to the marketing and sale of ACTIQ, and in failing to do so, violated their fiduciary duties to the stockholders.  The complaint seeks an unspecified amount of money damages, disgorgement of all compensation and other equitable relief.  We believe the plaintiff’s allegations in this matter are without merit and we intend to vigorously defend ourselves in this matter.

 

DURASOLV

 

In the third quarter of 2007, the U.S. Patent and Trademark Office (“PTO”) notified us that, on re-examination, it has rejected the claims in the two U.S. patents for our DURASOLV ODT technology.  We have filed notices of appeal of the PTO’s decisions.  While we intend to vigorously defend these patents, these efforts, ultimately, may not be successful.  The invalidity of the DURASOLV patents could have an adverse impact on revenues from our drug delivery business.

 

Other Matters

 

We are a party to certain other litigation in the ordinary course of our business, including, among others, European patent oppositions, patent infringement litigation and matters alleging employment discrimination, product liability and breach of commercial contract. We do not believe these matters, even if adversely adjudicated or settled, would have a material adverse effect on our financial condition, results of operations or cash flows.

 

12.  COMPREHENSIVE INCOME

 

The components of total comprehensive income are as follows:

 

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Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Net income (loss)

 

$

112,043

 

$

(306,763

)

$

210,962

 

$

(235,886

)

Foreign currency translation gains (losses)

 

(41,317

)

21,681

 

(19,300

)

39,155

 

Prior service costs and gains on retirement-related plans, net of tax

 

(36

)

14

 

(101

)

59

 

Unrealized investment gains (losses)

 

 

36

 

(8

)

30

 

Other comprehensive income (losses)

 

(41,353

)

21,731

 

(19,409

)

39,244

 

Comprehensive income (loss)

 

$

70,690

 

$

(285,032

)

$

191,553

 

$

(196,642

)

 

13.  EARNINGS PER SHARE (“EPS”)

 

Basic income per common share is computed based on the weighted average number of common shares outstanding during the period. Diluted income per common share is computed based on the weighted average number of common shares outstanding and, if there is net income during the period, the dilutive impact of common stock equivalents outstanding during the period.  Common stock equivalents are measured under the treasury stock method or “if converted” method, as follows:

 

Treasury Stock Method:

 

Employee stock options

Restricted stock units

Zero Coupon Convertible Notes issued in December 2004 (the “New Zero Coupon Notes”)

2.0% Notes

Warrants

 

“If-Converted” Method:

 

Zero Coupon Convertible Notes issued in June 2003 (the “Old Zero Coupon Notes”)

 

The 2.0% Notes and New Zero Coupon Notes each are considered to be Instrument C securities as defined by EITF 90-19, “Convertible Bonds with Issuer Option to Settle for Cash upon Conversion” (“EITF 90-19”); therefore, these notes are included in the dilutive earnings per share calculation using the treasury stock method. Under the treasury stock method, we must calculate the number of shares issuable under the terms of these notes based on the average market price of the stock during the period (assuming the average market price is above the applicable conversion prices of the 2.0% and New Zero Coupon Notes), and include that number in the total diluted shares figure for the period.

 

We have entered into convertible note hedge and warrant agreements that, in combination, have the economic effect of reducing the dilutive impact of the 2.0% Notes and the New Zero Coupon Notes. SFAS No. 128, “Earnings Per Share” (“SFAS 128”), however, requires us to analyze separately the impact of the convertible note hedge and warrant agreements on diluted EPS. As a result, the purchases of the convertible note hedges are excluded because their impact will always be anti-dilutive. SFAS 128 further requires that the impact of the sale of the warrants be computed using the treasury stock method. For example, using the treasury stock method, if the average price of our stock during the period ended December 31, 2007 had been $75.00, $85.00 or $95.00, the shares from the warrants to be included in diluted EPS would have been 2.1 million, 5.0 million and 7.3 million shares, respectively. The total number of shares that could potentially be included under the warrants is 26.8 million.

 

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The number of shares included in the diluted EPS calculation for the convertible subordinated notes and warrants is as follows:

 

 

 

Three months ended

 

Nine months ended

 

 

 

September 30,

 

September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Average market price per share of Cephalon stock

 

$

74.72

 

$

74.80

 

$

68.46

 

$

75.15

 

 

 

 

 

 

 

 

 

 

 

Shares included in diluted EPS calculation:

 

 

 

 

 

 

 

 

 

2.0% Notes

 

6,584

 

 

5,581

 

 

New Zero Coupon Notes

 

861

 

 

825

 

 

Warrants related to 2.0% Notes

 

1,793

 

 

155

 

 

Warrants related to New Zero Coupon Notes

 

125

 

 

 

 

Total (Treasury Stock Method)

 

9,363

 

 

6,561

 

 

Other (“If-Converted” Method)

 

2

 

 

5

 

 

Total

 

9,365

 

 

6,566

 

 

 

The following is a reconciliation of net income and weighted average common shares outstanding for purposes of calculating basic and diluted income per common share:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Basic income (loss) per common share computation:

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) used for basic income (loss) per common share

 

$

112,043

 

$

(306,763

)

$

210,962

 

$

(235,886

)

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares used for basic income (loss) per common share

 

68,118

 

66,931

 

67,855

 

66,398

 

 

 

 

 

 

 

 

 

 

 

Basic income (loss) per common share

 

$

1.64

 

$

(4.58

)

$

3.11

 

$

(3.55

)

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Diluted income (loss) per common share computation:

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) used for basic income (loss) per common share

 

$

112,043

 

$

(306,763

)

$

210,962

 

$

(235,886

)

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares used for basic income (loss) per common share

 

68,118

 

66,931

 

67,855

 

66,398

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Convertible subordinated notes and warrants

 

9,365

 

 

6,566

 

 

Employee stock options and restricted stock units

 

1,437

 

 

1,159

 

 

Weighted average shares used for diluted income (loss) per common share

 

78,920

 

66,931

 

75,580

 

66,398

 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share

 

$

1.42

 

$

(4.58

)

$

2.79

 

$

(3.55

)

 

The following reconciliation shows the shares excluded from the calculation of diluted income per common share as the inclusion of such shares would be anti-dilutive:

 

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Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Weighted average shares excluded:

 

 

 

 

 

 

 

 

 

Convertible subordinated notes and warrants

 

23,233

 

35,020

 

25,602

 

35,096

 

Employee stock options and restricted stock units

 

1,942

 

2,934

 

2,917

 

3,028

 

 

 

25,175

 

37,954

 

28,519

 

38,124

 

 

14.  SEGMENT AND SUBSIDIARY INFORMATION

 

Revenues for the three months ended September 30:

 

 

 

2008

 

2007

 

 

 

United
States

 

Europe

 

Total

 

United
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

241,366

 

$

17,793

 

$

259,159

 

$

202,202

 

$

14,904

 

$

217,106

 

GABITRIL

 

12,176

 

2,337

 

14,513

 

12,952

 

881

 

13,833

 

CNS

 

253,542

 

20,130

 

273,672

 

215,154

 

15,785

 

230,939

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

21,392

 

14,401

 

35,793

 

45,946

 

10,007

 

55,953

 

Generic OTFC

 

19,569

 

 

19,569

 

32,689

 

 

32,689

 

FENTORA

 

41,330

 

 

41,330

 

33,193

 

 

33,193

 

AMRIX

 

20,512

 

 

20,512

 

 

 

 

Pain

 

102,803

 

14,401

 

117,204

 

111,828

 

10,007

 

121,835

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

24,551

 

 

24,551

 

 

 

 

Other Oncology

 

4,691

 

23,195

 

27,886

 

4,301

 

18,405

 

22,706

 

Oncology

 

29,242

 

23,195

 

52,437

 

4,301

 

18,405

 

22,706

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

11,351

 

35,000

 

46,351

 

14,990

 

38,259

 

53,249

 

Total Sales

 

396,938

 

92,726

 

489,664

 

346,273

 

82,456

 

428,729

 

Other Revenues

 

8,471

 

347

 

8,818

 

8,823

 

869

 

9,692

 

Total External Revenues

 

405,409

 

93,073

 

498,482

 

355,096

 

83,325

 

438,421

 

Inter-Segment Revenues

 

3,697

 

6,609

 

10,306

 

1,356

 

13,051

 

14,407

 

Elimination of Inter-Segment Revenues

 

(3,697

)

(6,609

)

(10,306

)

(1,356

)

(13,051

)

(14,407

)

Total Revenues

 

$

405,409

 

$

93,073

 

$

498,482

 

$

355,096

 

$

83,325

 

$

438,421

 

 

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Table of Contents

 

Revenues for the nine months ended September 30:

 

 

 

2008

 

2007

 

 

 

United
States

 

Europe

 

Total

 

United
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

658,777

 

$

48,428

 

$

707,205

 

$

593,394

 

$

39,171

 

$

632,565

 

GABITRIL

 

37,614

 

6,669

 

44,283

 

39,814

 

6,268

 

46,082

 

CNS

 

696,391

 

55,097

 

751,488

 

633,208

 

45,439

 

678,647

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

96,960

 

40,734

 

137,694

 

157,097

 

28,638

 

185,735

 

Generic OTFC

 

75,845

 

 

75,845

 

97,562

 

 

97,562

 

FENTORA

 

116,637

 

 

116,637

 

101,224

 

 

101,224

 

AMRIX

 

47,399

 

 

47,399

 

 

 

 

Pain

 

336,841

 

40,734

 

377,575

 

355,883

 

28,638

 

384,521

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

38,932

 

 

38,932

 

 

 

 

Other Oncology

 

14,259

 

70,837

 

85,096

 

13,044

 

56,645

 

69,689

 

Oncology

 

53,191

 

70,837

 

124,028

 

13,044

 

56,645

 

69,689

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

37,995

 

117,517

 

155,512

 

40,823

 

114,122

 

154,945

 

Total Sales

 

1,124,418

 

284,185

 

1,408,603

 

1,042,958

 

244,844

 

1,287,802

 

Other Revenues

 

24,377

 

1,436

 

25,813

 

32,315

 

2,550

 

34,865

 

Total External Revenues

 

1,148,795

 

285,621

 

1,434,416

 

1,075,273

 

247,394

 

1,322,667

 

Inter-Segment Revenues

 

14,364

 

20,421

 

34,785

 

15,702

 

51,222

 

66,924

 

Elimination of Inter-Segment Revenues

 

(14,364

)

(20,421

)

(34,785

)

(15,702

)

(51,222

)

(66,924

)

Total Revenues

 

$

1,148,795

 

$

285,621

 

$

1,434,416

 

$

1,075,273

 

$

247,394

 

$

1,322,667

 

 

Income (loss) before income taxes by segment:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

United States

 

$

56,953

 

$

(279,352

)

$

217,645

 

$

(125,375

)

Europe

 

(7,281

)

(2,448

)

(11,058

)

(7,898

)

Total

 

$

49,672

 

$

(281,800

)

$

206,587

 

$

(133,273

)

 

Total assets:

 

 

 

September 30,
2008

 

December 31,
2007*

 

United States

 

$

2,666,267

 

$

2,444,804

 

Europe

 

989,338

 

1,061,465

 

Total

 

$

3,655,605

 

$

3,506,269

 

 


*                 Certain reclassifications of prior year amounts have been made to conform to the current year presentation.

 

15.  INCOME TAXES

 

The Internal Revenue Service (“IRS”) has completed its examination of Cephalon, Inc.’s 2003, 2004 and 2005 federal income tax returns and on October 2, 2008, we received a summary of all Income Tax Examination Changes from the IRS.

 

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Table of Contents

 

Subject to IRS compliance review, we believe this will effectively complete the IRS audit of Cephalon Inc. federal income tax returns for the years under review.  We also remain open for examination by the IRS for 2006 and 2007.  Zeneus Pharma S.a.r.L. is under examination by the French Tax Authorities for 2003 and 2004.  During 2008 Cephalon France completed its income tax audit for the years 2004 and 2005 with no material findings. Cephalon Pharma Gmbh, in Germany, is under examination for 2000 to 2004.  Cephalon Pharma S.L., in Spain, is under examination for 2003, and on September 30, 2008 received a proposal from the Spanish authorities to settle this examination. Cephalon has, in principle, agreed to the proposal and will settle this examination during the fourth quarter. Our filings in the United Kingdom remain open to examination for 2006 and 2007.  In other significant foreign jurisdictions, the tax years that remains open for potential examination range from 2000 to 2007.  We do not believe at this time that the results of these examinations will have a material impact on the financial statements.

 

In the regular course of business, various state and local tax authorities also conduct examinations of our state and local income tax returns.  Depending on the state, state income tax returns are generally subject to examination for a period of three to five years after filing.  The state impact of any federal changes from the 2003 to 2005 IRS examinations, and the 2006 and 2007 calendar years, remains subject to examination by various states for a period of up to one year after formal notification to the states.  We currently have several state income tax returns in the process of examination.

 

During the third quarter of 2008, we recognized a tax benefit of $84.5 million, of which $82.3 million related to the settlement with the USAO, for which the related expense was recorded in 2007, and $2.2 million related to the settlements with Connecticut and Massachusetts, for which the related expense was recorded in the third quarter of 2008. These settlements are discussed in Note 11.

 

16. SUBSEQUENT EVENTS

 

As a result of our USAO settlement, as further described in Note 11, in October 2008 we paid a total of $423.1 million plus $11.3 million interest from cash and cash equivalents on hand.  The remaining settlement payments of $1.9 million plus interest related to the USAO settlement are expected to be paid during the fourth quarter of 2008.

 

On November 3, 2008, we entered into a license and convertible note transaction with Acusphere, Inc.  In connection with the transaction,  Acusphere granted the Cephalon an exclusive worldwide license to all intellectual property of Acusphere relating to celecoxib to develop and market celecoxib for all current and future indications. In connection with this license, we paid Acusphere an upfront fee of $5 million and agreed to pay a milestone upon FDA approval of the first new drug application prepared by us with respect to celecoxib for any indication, as well as royalties on net sales.  In addition, we purchased a $15 million senior secured three-year convertible note (the “Note”) from Acusphere, secured by substantially all the assets of Acusphere (including Acusphere’s intellectual property).  The Note is convertible at our option at any time prior to November 3, 2009 into either (i) a number of shares of Acusphere common stock at least equal to 51% of Acusphere’s outstanding common stock on a fully-diluted basis on the date of conversion of the Note, (ii) an exclusive license to all intellectual property of Acusphere relating to Imagify™ (perflubutane polymer microspheres) to use, distribute and sell Imagify for all current and future indications worldwide excluding those European countries subject to Acusphere’s agreement with Nycomed Danmark ApS, or (iii) a $15 million credit against the future milestone payment under the celecoxib license agreement.

 

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

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K for the year ended December 31, 2007, as well as the “Risk Factors” contained in Part II, Item 1A of this Quarterly Report on Form 10-Q.

 

EXECUTIVE SUMMARY

 

Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat human diseases. We currently focus our efforts in four core therapeutic areas: central nervous system (“CNS”) disorders, pain, oncology and addiction. In addition to conducting an active research and development program, we market eight proprietary products in the United States and numerous products in various countries throughout Europe.  Consistent with our core therapeutic areas, we have aligned our approximately 690-person U.S. field sales and sales management teams by area.  In Europe, we have a sales and marketing organization numbering approximately 400 persons that supports our presence in nearly 20 European countries, including France, the United Kingdom, Germany, Italy and Spain.

 

Our most significant product is PROVIGIL® (modafinil) Tablets [C-IV], which comprised 50% of our total consolidated net sales for the nine months ended September 30, 2008, of which 93% was in the U.S. market.  For the nine months ended September 30, 2008, consolidated net sales of PROVIGIL increased 12% over the nine months ended September 30, 2007.  PROVIGIL is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.  With respect to the marketing of PROVIGIL in the United States, on August 29, 2008, we terminated our co-promotion agreement with Takeda Pharmaceuticals North America, Inc. (“TPNA”) effective November 1, 2008.  We currently intend to supplement our existing sales teams with an additional 270 sales representatives who will begin promoting our products in the first quarter of 2009.  We plan to accomplish this through a combination of new hires and/or use of a contract sales force.  In June 2007, we secured final U.S. Food and Drug Administration (the “FDA”) approval of NUVIGIL® (armodafinil) Tablets [C-IV] for the same indications as PROVIGIL.  NUVIGIL is a single-isomer formulation of modafinil, the active ingredient in PROVIGIL.  The product is protected by a composition of matter patent that will expire on December 18, 2023 and covers a novel polymorphic form of armodafinil, the active pharmaceutical ingredient in NUVIGIL.  We currently intend to launch NUVIGIL in the second half of 2009.

 

Our two next most significant products are FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] (including our generic version of ACTIQ (“generic OTFC”)).  Together, these products comprise 23% of our total consolidated net sales for the nine months ended September 30, 2008, of which 88% was in the U.S. market.   In October 2006, we launched in the United States FENTORA, our next-generation proprietary pain product.  FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.  In April 2008, we received marketing authorization from the European Commission for EFFENTORA™ for the same indication as FENTORA and expect to launch the product in certain countries in the first quarter of 2009.  We have focused our clinical strategy for FENTORA on studying the product in opioid-tolerant patients with breakthrough pain associated with chronic pain conditions, such as neuropathic pain and back pain.  In November 2007, we submitted a supplemental new drug application (“sNDA”) to the FDA seeking approval to market FENTORA for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions.  The FDA held an Advisory Committee meeting on May 6, 2008 to discuss the FENTORA sNDA.  At that meeting, the Advisory Committee voted not to recommend approval of the FENTORA sNDA.  On September 15, 2008, we received a complete response letter, in which the FDA requested that we implement and demonstrate the effectiveness of proposed enhancements to the current FENTORA risk management program.  In accordance with new FDA regulations, we anticipate receiving a second letter from the FDA requesting that the FENTORA Risk Minimization Action Plan (RiskMAP) be converted to incorporate the new standards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan.  To address the FDA’s requests, we plan to implement COVERS™, a first-of-its-kind initiative designed to minimize the potential risk of overdose from an opioid through appropriate patient selection.  With respect to ACTIQ, its sales have been meaningfully eroded by the launch of FENTORA and by generic OTFC products sold since June 2006 by Barr Laboratories, Inc. and by us through our sales agent, Watson Pharmaceuticals, Inc.  We expect this erosion will continue throughout the remainder of  2008.

 

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In August 2007, we acquired the North American rights to AMRIX® (cyclobenzaprine hydrochloride extended-release capsules).  The FDA approved AMRIX for sale in the United States in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasms associated with acute, painful musculoskeletal conditions.  We made the product available in the United States in October 2007 and commenced a full U.S. launch in November 2007.  In February 2008, we entered into an agreement with a contract sales organization to add 120 sales representatives to our field sales team detailing AMRIX.  In June 2008, the U.S. Patent and Trademark Office issued a pharmaceutical formulation patent for AMRIX; this patent expires in February 2025.

 

In March 2008, we received FDA approval of TREANDA for the treatment of patients with chronic lymphocytic leukemia (“CLL”) and we launched the product in April 2008.  In October 2008, we received FDA approval of TREANDA® (bendamustine hydrochloride) for treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (“NHL”) who have progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.  The FDA has granted an orphan drug designation for the CLL indication for TRENDA.

 

On August 15, 2008, we established a $200 million, three-year revolving credit facility with JP Morgan Chase Bank, N.A. and certain other lenders.  The credit facility is available for letters of credit, working capital and general corporate purposes and is guaranteed by certain of our domestic subsidiaries.  The credit agreement contains standard covenants, including but not limited to covenants related to total debt to consolidated EBITDA (as defined in the credit agreement), senior debt to consolidated EBITDA, interest expense coverage and limitations on capital expenditures, asset sales, mergers and acquisitions, indebtedness, liens, and transactions with affiliates.  As of the date of this filing, we have not drawn any amounts under the credit facility.

 

We have significant discovery research programs focused on developing therapeutics to treat neurological disorders and cancers. Our technology principally focuses on an understanding of kinases and proteases and the role they play in cellular integrity, survival and proliferation. We have coupled this knowledge with a library of novel, potent, small, orally-active synthetic molecules that inhibit the activities of specific kinases.  We also work with our collaborative partners to provide a more diverse therapeutic breadth and depth to our research effort.

 

While we seek to increase profitability and cash flow from operations, we will need to continue to achieve growth of product sales and other revenues sufficient for us to attain these objectives. The rate of our future growth will depend, in part, upon our ability to obtain and maintain adequate intellectual property protection for our currently marketed products, and to successfully develop or acquire and commercialize new product candidates.

 

As a biopharmaceutical company, our future success is highly dependent on obtaining and maintaining patent protection or regulatory exclusivity for our products and technology. We intend to vigorously defend the validity, and prevent infringement, of our patents. The loss of patent protection or regulatory exclusivity on any of our existing products, whether by third-party challenge, invalidation, circumvention, license or expiration, could materially impact our results of operations.   In late 2005 and early 2006, we entered into settlement agreements with each of Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Ranbaxy Laboratories Limited and Barr Laboratories Inc. As part of these separate settlements, we agreed to grant to each of these parties a non-exclusive royalty-bearing license to market and sell a generic version of PROVIGIL in the United States, effective in April 2012. In February 2008, the U.S. Federal Trade Commission (“FTC”) filed suit against us in U.S. District Court for the District of Columbia challenging the validity of the settlement and related agreements.  We filed a motion to transfer the case to the U.S. District Court for the Eastern District of Pennsylvania, which was granted in April 2008.  For more information concerning these settlements, see Note 11 to our Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q.

 

In April 2008 and June 2008, we received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Watson Laboratories, Inc. and Barr, respectively, requesting approval to market and sell a generic equivalent of FENTORA.  Both Watson and Barr allege that our U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the product described in their respective ANDAs.  The 6,200,604 and 6,974,590 patents cover methods of use for FENTORA and do not expire until 2019.  In June 2008 and July 2008, we and our wholly-owned subsidiary, CIMA LABS INC., filed lawsuits in U.S. District Court in Delaware against Watson and Barr for infringement of these patents.  Under the provisions of the Hatch-Waxman Act, the filing of these lawsuits stays any FDA approval of each ANDA until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the date of our receipt of the respective Paragraph IV certification letter. We intend to vigorously defend our intellectual property rights.

 

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In October 2008, we, together with our partner, Eurand NV, received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan and Barr, each requesting approval to market and sell a generic equivalent of AMRIX.  Mylan alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or unenforceability of the Eurand patent.  Barr alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.  The 7,387,793 patent covers extended-release formulations containing cyclobenzaprine and does not expire until February 26, 2025.  Eurand and Cephalon currently are reviewing the respective letters and, by statute, Eurand, as patent holder, has 45 days to initiate a patent infringement lawsuit against Mylan and/or Barr.  Such a lawsuit would automatically prevent the FDA from approving the Mylan ANDA and/or the Barr ANDA, as the case may be, until the earlier of a district court decision or 30 months from our receipt of the applicable letter. Eurand and Cephalon have not filed a patent infringement lawsuit against either Mylan or Barr as of the filing date of this report. Working with Eurand, we intend to vigorously defend the AMRIX intellectual property rights.

 

In early November 2007, we announced that we had reached an agreement in principle with the U.S. Attorney’s Office (“USAO”) in Philadelphia and the DOJ with respect to the USAO investigation that began in September 2004.  On September 29, 2008, to finalize our previously announced agreement in principle, we entered into a settlement agreement (the “Settlement Agreement”) with the DOJ, the USAO, the Office of Inspector General of the Department of Health and Human Services (“OIG”), TRICARE Management Activity, the U.S. Office of Personnel Management (collectively, the “United States”) and the relators identified in the Settlement Agreement (the “Relators”) to settle the outstanding False Claims Act claims alleging off-label promotion of ACTIQ and PROVIGIL from January 1, 2001 through December 31, 2006 and GABITRIL from January 2, 2001 through February 18, 2005 (the “Claims”). As part of the Settlement Agreement we agreed to pay a total of $375 million (the “Payment”) plus interest of $11.3 million. We also agreed to pay the Relators’ attorneys’ fees.  Pursuant to the Settlement Agreement, the United States and the Relators released us from all Claims and the United States agreed to refrain from seeking our exclusion from Medicare/Medicaid, the TRICARE Program or other federal health care programs.  In connection with the Settlement Agreement, we pled guilty to one misdemeanor violation of the U.S. Food, Drug and Cosmetic Act and agreed to pay $50 million (in addition to the Payment), of which $40 million applied to a criminal fine and $10 million applied to satisfy the forfeiture obligation.

 

As part of the Settlement Agreement, we entered into a five-year Corporate Integrity Agreement (the “CIA”) with the OIG.  The CIA provides criteria for establishing and maintaining compliance.  We are also subject to periodic reporting and certification requirements attesting that the provisions of the CIA are being implemented and followed. We also agreed to enter into a State Settlement and Release Agreement (the “State Settlement Agreement”) with each of the 50 states and the District of Columbia.  Upon entering into the State Settlement Agreement, a state will receive its portion of the Payment allocated for the compensatory state Medicaid payments and related interest amounts.  Each state also agrees to refrain from seeking our exclusion from its Medicaid program.

 

On September 29, 2008, we also announced that we had entered into an Assurance of Voluntary Compliance (the “Connecticut Assurance”) with the Attorney General of the State of Connecticut and the Commissioner of Consumer Protection of the State of Connecticut (collectively, “Connecticut”) to settle Connecticut’s investigation of our promotion of ACTIQ, GABITRIL and PROVIGIL.  Pursuant to the Connecticut Assurance, (i) we agreed to pay a total of $6.15 million to Connecticut, of which $3.8 million will fund Connecticut Department of Public Health cancer initiatives and $0.2 million will fund a state electronic prescription monitoring program; and (ii) Connecticut released us from any claim relating to the promotional practices that were the subject of Connecticut’s investigation.  On the same date we also entered into an Assurance of Discontinuance (the “Massachusetts Settlement Agreement”) with the Attorney General of the Commonwealth of Massachusetts (“Massachusetts”) to settle Massachusetts’ investigation of our  promotional practices with respect to fentanyl-based products.  Pursuant to the Massachusetts Settlement Agreement, (i) we agreed to pay a total of $0.7 million to Massachusetts, of which $0.45 million will fund Massachusetts cancer initiatives and benefit consumers in Massachusetts; and (ii) Massachusetts released us from any claim relating to the promotional practices that were the subject of Massachusetts’ investigation.

 

RESTRUCTURING

 

On January 15, 2008, we announced a restructuring plan under which we intend to (i) transition manufacturing activities at our CIMA LABS INC. (“CIMA”) facility in Eden Prairie, Minnesota, to our recently expanded manufacturing facility in Salt Lake City, Utah, and (ii) consolidate at CIMA’s Brooklyn Park, Minnesota, facility certain drug delivery research and development activities currently performed in Salt Lake City. The transition of manufacturing activities and the closure of the Eden Prairie facility are expected to be completed within two to three years.  The consolidation of drug

 

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delivery research and development activities at Brooklyn Park is expected to be completed in 2008.  The plan is intended to increase efficiencies in manufacturing and research and development activities, reduce our cost structure and enhance competitiveness.

 

As a result of this plan, we will incur certain costs associated with exit or disposal activities.  As part of the plan, we estimate that approximately 90 jobs will be eliminated in total, with approximately 170 net jobs eliminated at CIMA and approximately 80 net jobs added in Salt Lake City.

 

The total estimated pre-tax costs of the plan are as follows:

 

Severance costs

 

$

14-16 million

 

Manufacturing and personnel transfer costs

 

$

7- 8 million

 

Total

 

$

21-24 million

 

 

The estimated pre-tax costs of the plan are expected to be recognized in 2008 through 2011 and are included in the United States segment.  In addition to the costs described above, we have started to recognize pre-tax, non-cash accelerated depreciation of plant and equipment at the Eden Prairie facility, which we expect to total approximately $18 million to $22 million.

 

INVENTORY

 

Over the past few years, we have been developing a manufacturing process for the active pharmaceutical ingredient in NUVIGIL that is more cost effective than our prior process of separating modafinil into armodafinil.  As a result of our plan to manufacture armodafinil in the future using this new process and our decision to launch NUVIGIL in the second half of 2009, we assessed the potential impact of these items on certain of our existing agreements to purchase modafinil.  Under these contracts, we have agreed to purchase minimum amounts of modafinil through 2012, with aggregate purchase commitments totaling $64.4 million as of September 30, 2008.  Based on our third quarter assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.

 

PROPERTY, PLANT and EQUIPMENT

 

On September 18, 2008, our subsidiary Cephalon France SAS informed the French Works Councils of its intention to search for a potential acquiror of the manufacturing facility at Mitry-Mory, France.  We are considering the proposed divestiture due to a reduction of manufacturing activities at the Mitry-Mory manufacturing site.  The proposed divestiture is subject to completion of a formal consultation process with the French Works Councils and employees representatives.

 

As a result of this decision, we reevaluated the remaining carrying value and useful life of the Mitry-Mory assets and reduced the estimated useful life to approximately two years.  During the quarter we have recorded pre-tax, non-cash charges associated with accelerated depreciation of plant and equipment of $3.2 million related to the proposed divestiture based on the new estimated useful life.  As of September 30, 2008, we had $43.3 million of net property and equipment related to the Mitry-Mory facility included on our balance sheet.

 

TERMINATION OF CO-PROMOTION AGREEMENT

 

With respect to the marketing of PROVIGIL in the United States, on August 29, 2008, we terminated our co-promotion agreement with Takeda Pharmaceuticals North America, Inc. (“TPNA”) effective November 1, 2008.  As a result of the termination, we will be required under the agreement to make payments to TPNA during the three years following the termination of the agreement (the “Sunset Payments”).  The Sunset Payments will be calculated based on a percentage of royalties to TPNA during the final twelve months of the agreement.  In September 2008, we recorded an accrual of $27.2 million, representing the present value of the estimated Sunset Payments due to TPNA.

 

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RESULTS OF OPERATIONS

 

(In thousands)

 

Three months ended September 30, 2008 compared to three months ended September 30, 2007:

 

 

 

Three months ended

 

 

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

 

 

2008

 

2007

 

% Increase (Decrease)

 

 

 

United
States

 

Europe

 

Total

 

United
States

 

Europe

 

Total

 

United
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

241,366

 

$

17,793

 

$

259,159

 

$

202,202

 

$

14,904

 

$

217,106

 

19

%

19

%

19

%

GABITRIL

 

12,176

 

2,337

 

14,513

 

12,952

 

881

 

13,833

 

(6

)

165

 

5

 

CNS

 

253,542

 

20,130

 

273,672

 

215,154

 

15,785

 

230,939

 

18

 

28

 

19

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

21,392

 

14,401

 

35,793

 

45,946

 

10,007

 

55,953

 

(53

)

44

 

(36

)

Generic OTFC

 

19,569

 

 

19,569

 

32,689

 

 

32,689

 

(40

)

 

(40

)

FENTORA

 

41,330

 

 

41,330

 

33,193

 

 

33,193

 

25

 

 

25

 

AMRIX

 

20,512

 

 

20,512

 

 

 

 

 

 

 

Pain

 

102,803

 

14,401

 

117,204

 

111,828

 

10,007

 

121,835

 

(8

)

44

 

(4

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

24,551

 

 

24,551

 

 

 

 

 

 

 

Other Oncology

 

4,691

 

23,195

 

27,886

 

4,301

 

18,405

 

22,706

 

9

 

26

 

23

 

Oncology

 

29,242

 

23,195

 

52,437

 

4,301

 

18,405

 

22,706

 

580

 

26

 

131

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

11,351

 

35,000

 

46,351

 

14,990

 

38,259

 

53,249

 

(24

)

(9

)

(13

)

Total Sales

 

396,938

 

92,726

 

489,664

 

346,273

 

82,456

 

428,729

 

15

 

12

 

14

 

Other Revenues

 

8,471

 

347

 

8,818

 

8,823

 

869

 

9,692

 

(4

)

(60

)

(9

)

Total Revenues

 

$

405,409

 

$

93,073

 

$

498,482

 

$

355,096

 

$

83,325

 

$

438,421

 

14

%

12

%

14

%

 

Sales—In the United States, we sell our proprietary products to pharmaceutical wholesalers, the largest three of which accounted for 65% of our total consolidated gross sales for the three months ended September 30, 2008. Decisions made by these wholesalers regarding the levels of inventory they hold (and thus the amount of product they purchase from us) can materially affect the level of our sales in any particular period and thus may not necessarily correlate to the number of prescriptions written for our products as reported by IMS Health Incorporated.

 

We have distribution service agreements with our major wholesaler customers. These agreements obligate the wholesalers to provide us with periodic retail demand information and current inventory levels for our products held at their warehouse locations; additionally, the wholesalers have agreed to manage the variability of their purchases and inventory levels within specified limits based on product demand.

 

As of September 30, 2008, we received information from substantially all of our U.S. wholesaler customers about the levels of inventory they held for our U.S. branded products. Based on this information, which we have not independently verified, we believe that total inventory held at these wholesalers is approximately two to three weeks supply of our U.S. branded products at our current sales levels, remaining near the low end of this range at quarter end. At September 30, 2008, we believe that our generic OTFC inventory held at wholesalers and retailers is approximately three months.

 

For the three months ended September 30, 2008, sales were impacted by price changes, changes in the product sales allowances deducted from gross sales as described further below and by changes in the relative levels of the number of units of inventory held at wholesalers and retailers. For the three months ended September 30, 2008, total sales increased by 14% over the prior year. The key factors that contributed to the increase in sales are summarized by product as follows:

 

·                  In CNS, sales of PROVIGIL increased 19%. Sales of PROVIGIL in the U.S. increased by 19% as a result of 2008 domestic price increases, resulting in an average price increase of 20% period over period,  offset by a 1% decrease in U.S. prescriptions, according to IMS Health.  European sales of PROVIGIL increased 19% due to both increases in unit sales and the favorable effect of exchange rates.

 

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·                  In Pain, sales decreased 4%.  Sales of ACTIQ in the United States were impacted by domestic price increases in 2008, resulting in an average price increase of 25% period over period.  This price impact was offset by a 47% decrease in U.S. prescriptions, according to IMS Health, resulting from the continued erosion of sales due to the impact of generic competition to ACTIQ and by an increase in returns activity, as described below.  Sales of ACTIQ in Europe increased 44% due to increases in unit sales in France, Germany, UK and other areas, along with the favorable effect of exchange rates. Sales of FENTORA increased 25%, impacted by an average 16% domestic price increase, a decrease in coupon redemption activity, and an offsetting 21% decrease in prescriptions resulting from a challenging reimbursement environment and an overall decline in the rapid-onset fentanyl market.

 

·                  In Oncology, sales increased 131%, due primarily to the introduction of TREANDA in April 2008, while European oncology products increased 26%, due to an increase in unit sales of MYOCET® (liposomal doxorubicin) and favorable effect of exchange rate changes.

 

Other Revenues—The decrease of 9% from period to period is primarily due to lower revenues from our collaborators including royalties, milestone payments, and fees.

 

Analysis of gross sales to net sales—The following table presents the product sales allowances deducted from gross sales to arrive at a net sales figure:

 

 

 

Three months ended

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Gross sales

 

$

562,074

 

$

479,065

 

$

83,009

 

17

%

Product sales allowances:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

9,378

 

7,781

 

1,597

 

21

 

Wholesaler discounts

 

(10

)

5,373

 

(5,383

)

(100

)

Returns

 

16,687

 

(2,598

)

19,285

 

(742

)

Coupons

 

5,194

 

8,713

 

(3,519

)

(40

)

Medicaid discounts

 

11,493

 

10,648

 

845

 

8

 

Managed care and governmental contracts

 

29,668

 

20,419

 

9,249

 

45

 

 

 

72,410

 

50,336

 

22,074

 

 

 

Net sales

 

$

489,664

 

$

428,729

 

$

60,935

 

14

%

Product sales allowances as a percentage of gross sales

 

12.9

%

10.5

%

 

 

 

 

 

Prompt payment discounts, generally granted at 2% of sales, increased for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007 due to the increase in sales.  Wholesaler discounts decreased period over period as the price increases made during the quarter ended September 30, 2008 produced wholesaler credits that completely offset the wholesaler discounts that would have been recorded for the period.

 

Returns increased substantially during the third quarter of 2008 as a result of heightened ACTIQ returns.  Between March and July of 2006, we increased ACTIQ manufacturing levels to ensure sufficient supply as we switched manufacturing to FENTORA in anticipation of its launch and prepared for the transition of ACTIQ production to a new facility that opened in August 2006.  The expiration of this product in the third quarter of 2008 has resulted in increased returns.  We believe that the returns in the third quarter of 2008 are not indicative of future periods and therefore we have not adjusted our returns percentage as it relates to current ACTIQ sales.  In the third quarter of 2007, returns were impacted by a decrease in historical returns experience for our CNS products and by our analysis of retail pipeline data.  Coupons decreased period over period as a result of the decrease in coupon redemption activity for FENTORA.

 

Medicaid discounts increased at a rate lower than our increase in sales for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007 due to the decrease in utilization of pain products under Medicaid.  Managed care and governmental contracts increased for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007 due to additional rebates for certain managed care and governmental programs, particularly with respect to sales of PROVIGIL and generic OTFC.  In addition, during the three months ended September 30, 2008, we recognized a reserve of $4.6 million for amounts payable to the U.S. Department of Defense (“DoD”) under the new Tricare program effective January 28, 2008.  In the future, we expect product sales allowances as a percentage of gross

 

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sales to trend upward due to the impact of potential future price increases on Medicaid discounts and potential increases related to Medicaid, managed care and governmental contracts sales.

 

 

 

Three months ended

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

121,477

 

$

82,258

 

$

39,219

 

48

%

Research and development

 

88,325

 

93,527

 

(5,202

)

(6

)

Selling, general and administrative

 

222,948

 

186,456

 

36,492

 

20

 

Settlement reserve

 

7,450

 

369,000

 

(361,550

)

(98

)

Restructuring charges

 

1,497

 

 

1,497

 

 

 

 

$

441,697

 

$

731,241

 

$

(289,544

)

(40

)%

 

Cost of Sales—The cost of sales was 24.8% of net sales for the three months ended September 30, 2008 and 19.2% of net sales for the three months ended September 30, 2007. This increase resulted from a reserve for excess modafinil purchase commitments of $26.0 million (5.3% of net sales), based on our third quarter analysis of estimated future requirements.  In addition, we recorded accelerated depreciation charges within cost of sales in the third quarter of 2008 of $1.6 million (0.3% of net sales) related to the restructuring at our CIMA facility, and $2.9 million (0.6% of net sales) related to the proposed divestiture of our Mitry-Mory manufacturing site.

 

Research and Development Expenses—Research and development expenses decreased $5.2 million, or 6%, for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007. This decrease is primarily attributable to the recognition of a $15.0 million milestone payment related to our NDA filing for TREANDA in 2007, partially offset by an increase in clinical activity related to NUVIGIL.  For the three months ended September 30, 2008 and 2007, we recognized $7.3 million and $5.3 million, respectively, of depreciation expense included in research and development expenses.

 

Selling, General and Administrative Expenses—Selling, general and administrative expenses increased $36.5 million, or 20%, for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007, primarily due to the recognition of $27.2 million of estimated Sunset Payments due to TPNA, and to increased selling and marketing spending on the promotion of PROVIGIL and AMRIX, offset by a decrease in promotional spending on FENTORA.  For the three months ended September 30, 2008 and 2007, we recognized $5.3 million and $2.2 million, respectively, of depreciation expense included in selling, general and administrative expenses.

 

Settlement reserve — For the three months ended September 30, 2008, we recognized $7.4 million for the charges relating to the settlement of investigations by the states of Connecticut and Massachusetts, and for our estimate of attorneys’ fees for the Relators as part of the U.S. Attorney’s Office settlement.  For the three months ended September 30, 2007, we increased the existing settlement reserve by $369.0 million related to the terms of the agreement in principle reached with the U.S. Attorney’s Office.  See Note 11 to the Consolidated Financial Statements included in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

Restructuring charges—For the three months ended September 30, 2008, we recorded $1.5 million related to our restructuring plan to consolidate certain manufacturing and research and development activities within our U.S. locations.  These charges primarily consist of severance payments and accruals for employees who have or are expected to be terminated as a result of this restructuring plan.

 

 

 

Three months ended

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

$

4,002

 

$

8,868

 

$

(4,866

)

(55

)%

Interest expense

 

(8,831

)

(5,660

)

(3,171

)

56

 

Gain on extinguishment of debt

 

 

5,319

 

(5,319

)

(100

)

Other income (expense), net

 

(2,284

)

2,493

 

(4,777

)

(192

)

 

 

$

(7,113

)

$

11,020

 

$

(18,133

)

(165

)%

 

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Table of Contents

 

Other Income (Expense) — Other income (expense) decreased $18.1 million, or 165%, for the three months ended September 30, 2008 as compared to the three months ended September 30, 2007. The decrease was attributable to the following factors:

 

·                  a $4.9 million decrease in interest income, primarily due to lower U.S. average interest rates offset by higher average investment balances;

 

·                  a $3.2 million increase in interest expense, primarily due to the recognition of $3.8 million of estimated accrued interest related to the agreement in principle with the U.S. Attorney’s Office;

 

·                  a $5.3 million gain on the extinguishment of debt related to the Pennsylvania Industrial Development Board (“PIDA”) loan forgiveness in the third quarter of 2007; and

 

·                  a $4.8 million decrease in other income, net, primarily due to fluctuations in foreign currency gains and losses in the comparable periods.

 

 

 

Three months ended

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Income tax expense

 

$

(62,371

)

$

24,963

 

$

(87,334

)

(350

)%

 

Income Taxes— For the three months ended September 30, 2008, we recognized $62.4 million of income tax benefit on income before income taxes of $49.7 million.   This includes a tax benefit of $84.5 million, of which $82.3 million related to the settlement with the U.S. Attorney’s Office, for which the related expense was recorded in 2007, and $2.2 million related to the settlements with Connecticut and Massachusetts, for which the related expense was recorded in the third quarter of 2008. The three months ended September 30, 2008 also included an additional tax expense of $5.2 million return to provision adjustment for the 2007 federal tax returns filed in September 2008 and a release of $4.4 million in tax reserves for tax contingencies which were previously under audit by tax authorities. This compares to income tax expense for the three months ended September 30, 2007 of $25.0 million on loss before income taxes of $281.8 million, where we did not recognize a tax benefit for the increase in our U.S. Attorney’s Office settlement reserve recorded in the quarter due to the uncertainty associated with the tax treatment of any potential settlement.

 

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Table of Contents

 

Nine months ended September 30, 2008 compared to nine months ended September 30, 2007:

 

 

 

Nine months ended 
September 30,

 

 

 

 

 

 

 

 

 

2008

 

2007

 

% Increase (Decrease)

 

 

 

United
States

 

Europe

 

Total

 

United
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

658,777

 

$

48,428

 

$

707,205

 

$

593,394

 

$

39,171

 

$

632,565

 

11

%

24

%

12

%

GABITRIL

 

37,614

 

6,669

 

44,283

 

39,814

 

6,268

 

46,082

 

(6

)

6

 

(4

)

CNS

 

696,391

 

55,097

 

751,488

 

633,208

 

45,439

 

678,647

 

10

 

21

 

11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

96,960

 

40,734

 

137,694

 

157,097

 

28,638

 

185,735

 

(38

)

42

 

(26

)

Generic OTFC

 

75,845

 

 

75,845

 

97,562

 

 

97,562

 

(22

)

 

(22

)

FENTORA

 

116,637

 

 

116,637

 

101,224

 

 

101,224

 

15

 

 

15

 

AMRIX

 

47,399

 

 

47,399

 

 

 

 

 

 

 

Pain

 

336,841

 

40,734

 

377,575

 

355,883

 

28,638

 

384,521

 

(5

)

42

 

(2

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

38,932

 

 

38,932

 

 

 

 

 

 

 

Other Oncology

 

14,259

 

70,837

 

85,096

 

13,044

 

56,645

 

69,689

 

9

 

25

 

22

 

Oncology

 

53,191

 

70,837

 

124,028

 

13,044

 

56,645

 

69,689

 

308

 

25

 

78

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

37,995

 

117,517

 

155,512

 

40,823

 

114,122

 

154,945

 

(7

)

3

 

0

 

Total Sales

 

1,124,418

 

284,185

 

1,408,603

 

1,042,958

 

244,844

 

1,287,802

 

8

 

16

 

9

 

Other Revenues

 

24,377

 

1,436

 

25,813

 

32,315

 

2,550

 

34,865

 

(25

)

(44

)

(26

)

Total Revenues

 

$

1,148,795

 

$

285,621

 

$

1,434,416

 

$

1,075,273

 

$

247,394

 

$

1,322,667

 

7

%

15

%

8

%

 

Sales—For the nine months ended September 30, 2008, sales were impacted by price changes, changes in the product sales allowances deducted from gross sales as described further below and by changes in the relative levels of the number of units of inventory held at wholesalers and retailers. For the nine months ended September 30, 2008, total sales increased by 9% over the prior year. The key factors that contributed to the increase in sales are summarized by product as follows:

 

·                  In CNS, sales of PROVIGIL increased 12 percent. Sales of PROVIGIL in the U.S. increased 11%, due to domestic price increases of approximately 14% in February and 12% in August, resulting in an average price increase of 12.5% from period to period, offset by a 1% decrease in U.S. prescriptions, according to IMS Health.  European sales of PROVIGIL increased 24% due primarily to both increases in unit sales and to favorable effect of exchange rates.

 

·                  In Pain, sales decreased 2 percent. Sales of ACTIQ in the U.S. were impacted by increases in domestic prices of approximately 17% from period to period, offset by a 53% decrease in U.S. prescriptions, according to IMS Health, resulting from the continued erosion of sales due to the introduction of generic competition to ACTIQ and by an increase in returns activity, as described below. Sales of generic OTFC decreased 22% due to decreases in prices and to a 12% decrease in prescriptions according to IMS Health.  Sales of FENTORA increased 15% due primarily to an average 10% domestic price increase period over period.  AMRIX sales, which began in the fourth quarter of 2007, were $47.4 million.  During the remainder of 2008, while we expect continued growth from AMRIX, we expect overall sales of our other Pain products to decrease compared to the same period in 2007 and the first half of 2008 based on a shift in market share from ACTIQ to generic OTFC.

 

·                  In Oncology, sales increased 78 percent. U.S. sales increased due to sales of TREANDA, which began in April 2008.  Sales of our European oncology products increased 25%, due primarily to an increase in unit sales of MYOCET and favorable effect of exchange rates.

 

Other Revenues—The decrease of 26% from period to period is primarily due to a decrease in revenues from our collaborators including royalties, milestone payments and fees.

 

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Table of Contents

 

Analysis of gross sales to net sales—The following table presents the product sales allowances deducted from gross sales to arrive at a net sales figure:

 

 

 

Nine months ended 
September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Gross sales

 

$

1,600,034

 

$

1,444,003

 

$

156,031

 

11

%

Product sales allowances:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

26,176

 

23,639

 

2,537

 

11

 

Wholesaler discounts

 

5,910

 

15,723

 

(9,813

)

(62

)

Returns

 

26,842

 

9,258

 

17,584

 

190

 

Coupons

 

16,370

 

19,895

 

(3,525

)

(18

)

Medicaid discounts

 

29,314

 

29,277

 

37

 

0

 

Managed care and governmental contracts

 

86,819

 

58,409

 

28,410

 

49

 

 

 

191,431

 

156,201

 

35,230

 

 

 

Net sales

 

$

1,408,603

 

$

1,287,802

 

$

120,801

 

9

%

Product sales allowances as a percentage of gross sales

 

12.0

%

10.8

%

 

 

 

 

 

Prompt payment discounts, generally granted at 2% of sales, increased for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007 due to the increase in sales. Wholesaler discounts decreased period over period because price increases in 2008 produced wholesaler credits that partially offset the wholesaler discounts that would have been recorded for that same period.

 

Returns increased for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007 as a result of heightened ACTIQ returns.  Between March and July of 2006, we increased ACTIQ manufacturing levels to ensure sufficient supply as we switched manufacturing to FENTORA in anticipation of its launch and prepared for the transition of ACTIQ production to a new facility that opened in August 2006.  The expiration of this product in the third quarter of 2008 has resulted in increased returns.  We believe that the returns in the third quarter of 2008 are not indicative of future periods and therefore we have not adjusted our returns percentage as it relates to current ACTIQ sales.  Coupons decreased period over period as a result of the decrease in coupon redemption activity for FENTORA.

 

Medicaid discounts remained constant for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007 due to the lower Medicaid utilization of our Pain products.  Managed care and governmental contracts increased for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007 due to additional rebates for certain managed care and governmental programs, particularly with respect to sales of PROVIGIL and our generic OTFC product. In addition, we recognized a reserve of $12.2 million as of September 30, 2008 for amounts payable to the U.S. Department of Defense (“DoD”) under the new Tricare program effective January 28, 2008.  In the future, we expect product sales allowances as a percentage of gross sales to trend upward due to the impact of potential future price increases on Medicaid discounts and potential increases related to Medicaid, Medicare Part D, managed care and governmental contracts sales.

 

 

 

Nine months ended
September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

312,711

 

$

251,970

 

$

60,741

 

24

%

Research and development

 

250,169

 

274,078

 

(23,909

)

(9

)

Selling, general and administrative

 

631,832

 

527,962

 

103,870

 

20

 

Settlement reserve

 

7,450

 

425,000

 

(417,550

)

(98

)

Restructuring charge

 

6,973

 

 

6,973

 

 

Acquired in-process research and development

 

10,000

 

 

10,000

 

 

 

 

$

1,219,135

 

$

1,479,010

 

$

(259,875

)

(18

)%

 

Cost of SalesThe cost of sales was 22.2% of net sales for the nine months ended September 30, 2008 and 19.6% of net sales for the nine months ended September 30, 2007. This increase resulted from a reserve for excess modafinil purchase commitments of $26.0 million (1.8% of net sales), based on our analysis of estimated future requirements, and an increase in amortization expense of $12.7 million (0.9% of net sales) due primarily to the amortization recognized for AMRIX and TREANDA products rights.  In addition, we recorded accelerated depreciation charges within cost of sales for the nine

 

28



Table of Contents

 

months ended September 30, 2008 of $5.4 million (0.4% of net sales) related to restructuring at our CIMA facility, and $2.9 million (0.2% of net sales) related to the proposed divestiture of our Mitry-Mory manufacturing site.  The increase was partially offset by a charge of $3.5 million (0.3% of net sales) in the first quarter of 2007 for the termination of a materials supply agreement.

 

Research and Development Expenses—Research and development expenses decreased $23.9 million, or 9%, for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007. For the nine months ended September 30, 2007, we recognized $26.5 million in up-front payments related to rights acquired to certain development stage products.  This decrease is partially offset by an increase in clinical activity related to NUVIGIL.  For the nine months ended September 30, 2008 and 2007, we recognized $17.4 million and $15.6 million, respectively, of depreciation expense included in research and development expenses.

 

Selling, General and Administrative Expenses—Selling, general and administrative expenses increased $103.9 million, or 20%, for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007.  Other general and administrative expenses increased for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007 due to the recognition of $27.2 million of estimated Sunset Payments due to TPNA, to increased selling expenses associated with PROVIGIL, AMRIX, and TREANDA, and to the cessation of the reimbursement of expenses from Alkermes related to the promotion of VIVITROL, offset by a decrease in promotional spending on FENTORA.  For the nine months ended September 30, 2008 and 2007, we recognized $15.0 million and $9.0 million, respectively, of depreciation expense included in selling general and administrative expenses.

 

Settlement Reserve— For the nine months ended September 30, 2008, we recognized $7.4 million for the charges relating to the settlement of investigations by the states of Connecticut and Massachusetts, and for our estimate of attorneys’ fees for the Relators as part of the U.S. Attorney’s Office settlement.  For the nine months ended September 30, 2007, we established a reserve of $425.0 million related to our estimate of the minimum liability stemming from the resolution of the investigations by the U.S. Attorney’s Office.  This investigation was settled in September 2008.  See Note 11 to the Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

 

Restructuring charges—For the nine months ended September 30, 2008, we recorded $7.0 million related to our restructuring plan to consolidate certain manufacturing and research and development activities within our U.S. locations.  These charges primarily consist of severance payments and accruals for employees who have or are expected to be terminated as a result of this restructuring plan.

 

Acquired in-process research and development—For the nine months ended September 30, 2008, we recorded acquired in-process research and development of $10 million related to our license of technology in the field of oncology.

 

 

 

Nine months ended
September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

$

15,515

 

$

23,485

 

$

(7,970

)

(34

)%

Interest expense

 

(25,697

)

(15,272

)

(10,425

)

68

 

Gain on extinguishment of debt

 

 

5,319

 

(5,319

)

(100

)

Gain on sale of investment

 

 

5,791

 

(5,791

)

(100

)

Other income (expense), net

 

1,488

 

3,747

 

(2,259

)

(60

)

 

 

$

(8,694

)

$

23,070

 

$

(31,764

)

(138

)%

 

Other Income (Expense)—Other income (expense) decreased $31.8 million for the nine months ended September 30, 2008 as compared to the nine months ended September 30, 2007. The decrease was attributable to the following factors:

 

·                  an $8.0 million decrease in interest income due to lower investment returns and offset by higher average investment balances;

 

·                  a $10.4 million increase in interest expense due to the recognition of $11.3 million of estimated accrued interest related to the agreement with the U.S. Attorney’s Office;

 

29



Table of Contents

 

·                  a $5.3 million gain on extinguishment of debt related to the PIDA loan forgiveness in the third quarter of 2007;

 

·                  a $5.8 million gain on the sale of an investment in a privately-held company in 2007; and

 

·                  a $2.3 million decrease in other income, net, primarily due to fluctuations in foreign currency gains and losses in the comparable periods.

 

 

 

Nine months ended 
September 30,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Income tax expense

 

$

(4,375

)

$

102,613

 

$

(106,988

)

(104

)%

 

Income TaxesFor the nine months ended September 30, 2008 we recognized $4.4 million of income tax benefit on income before income taxes of $206.6 million, resulting in an overall effective tax rate of (2.1) percent.  This includes a tax benefit of $84.5 million, of which $82.3 million related to the settlement with the U.S. Attorney’s Office, for which the related expense was recorded in 2007, and $2.2 million related to the settlements with Connecticut and Massachusetts, for which the related expense was recorded in the third quarter of 2008. The nine months ended September 30, 2008 also included an additional tax expense of $5.2 million return to provision adjustment for the 2007 federal tax returns timely filed in September 2008 and a release of $4.4 million in tax reserves for tax contingencies which were previously under audit by tax authorities.  This compared to income tax expense for the nine months ended September 30, 2007 of $102.6 million on loss before income taxes of $133.3 million.  During the second quarter of 2007, Cephalon did not recognize a tax benefit for the U.S. Attorney’s Office settlement reserve due to the uncertainty associated with the tax treatment of any potential settlement.

 

LIQUIDITY AND CAPITAL RESOURCES

 

(In thousands)

 

Cash, cash equivalents and investments at September 30, 2008 were $846.6 million, representing 23% of total assets, compared to $826.3 million, representing 24% of total assets at December 31, 2007. During the second quarter of 2008, we paid $213.1 million upon conversion or redemption of our 2008 Zero Coupon Convertible Notes.

 

Our working capital deficit, which is calculated as current assets less current liabilities, was $240.0 million at September 30, 2008 compared to $583.8 million at December 31, 2007.  Our convertible notes contain conversion terms that will impact whether these notes are classified as current or long-term liabilities and consequently affect our working capital position. At September 30, 2008 and December 31, 2007, $1,020.0 million and $1,233.7 million, respectively, of our convertible subordinated notes were convertible into cash and shares of common stock and were therefore classified as current liabilities on our consolidated balance sheets.

 

On August 15, 2008, we established a $200 million, three-year revolving credit facility with JP Morgan Chase Bank, N.A. and certain other lenders.  The credit facility is available for letters of credit, working capital and general corporate purposes and is guaranteed by certain of our domestic subsidiaries.  The credit agreement contains standard covenants, including but not limited to covenants related to total debt to Consolidated EBITDA (as defined in the credit agreement), senior debt to Consolidated EBITDA, interest expense coverage and limitations on capital expenditures, asset sales, mergers and acquisitions, indebtedness, liens, and transactions with affiliates.  As of the date of this filing, we have not drawn any amounts under the credit facility.

 

The change in cash and cash equivalents is as follows:

 

 

 

Nine months ended

 

 

 

September 30,

 

 

 

2008

 

2007

 

Net cash provided by operating activities

 

$

282,777

 

$

274,321

 

Net cash used for investing activities

 

(79,910

)

(200,934

)

Net cash (used for) provided by financing activities

 

(174,340

)

81,279

 

Effect of exchange rate changes on cash and cash equivalents

 

(601

)

10,804

 

Net increase in cash and cash equivalents

 

$

27,926

 

$

165,470

 

 

30



Table of Contents

 

Net Cash Provided by Operating Activities

 

Cash provided by operating activities is primarily driven by income from sales of our products offset by the timing of receipts and payments in the ordinary course of business.  Included within cash used for operating activities in 2008 is the payment of $10.0 million related to an agreement to in-license certain technology in the field of oncology. The net loss for the nine months ended September 30, 2007 was offset by a change in accounts payable and accrued expenses of $425.0 million related to the agreement with the U.S. Attorney’s Office.

 

Net Cash Used for Investing Activities

 

Cash used in investing activities primarily relates to acquisitions of business, technologies, products and product rights and funds used for capital expenditures in property and equipment.

 

For the nine months ended September 30, 2008 and 2007, we made capital expenditures of $55.7 million and $70.9 million, respectively. Significant expenditures include the expansion and improvement of our facilities and our worldwide implementation of SAP®.  Cash used for intangible assets includes a payment of $25 million initiated in March 2008 upon FDA approval of TREANDA and $99.2 million paid in August 2007 in association with the acquisition of the North America rights to AMRIX from E. Claiborne Robins Company Inc.  Investment in third party is an equity investment of $6.2 million in a privately-held pharmaceutical company paid during the second quarter of 2008.  These uses of cash were partially offset by cash provided from sales and maturities of our investment portfolio. As of September 30, 2008, all available-for-sale instruments in our investment portfolio have been sold or have matured and the corresponding proceeds have been transferred into liquid cash equivalents with original maturities of three months or less from the date of purchase. Additionally, in June 2007, we received cash proceeds of $12.3 million on the sale of an investment in a privately-held company and recorded the related gain of $5.8 million in other income.

 

Net Cash (Used for) Provided by Financing Activities

 

Financing activities for the periods presented above primarily relate to proceeds from stock option exercises and payments on long-term debt.

 

Proceeds from exercises of stock options were $37.2 million and $74.4 million for the nine months ended September 30, 2008 and 2007, respectively. The corresponding windfall tax benefits from stock-based compensation for those same periods were $4.6 million and $9.9 million, respectively. During the second quarter of 2008, we paid $213.1 million upon conversion or redemption of our 2008 Zero Coupon Convertible Notes.

 

Commitments and Contingencies

 

There have been no material changes to the Contractual Obligations Table, presented in our Annual Report on Form 10-K for the year ended December 31, 2007.  The table excludes unrecognized tax benefits, which totaled $79.6 million as of January 1, 2008 and $85.9 million as of September 30, 2008.  We also expect to timely settle any federal tax assessments as a result of certain tax audits.   During the twelve months ending September 30, 2009, we expect to make $9.9 million cash tax payments related to unrecognized tax benefits recorded at September 30, 2008.

 

As of the filing date of this report, as discussed in Note 16 to our Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q, we paid a total of $423.1 million plus $11.3 million interest from cash and cash equivalents on hand in October 2008 relating to the USAO settlement.  The remaining settlement payments of $1.9 million plus interest related to the USAO settlement are expected to be paid during the fourth quarter of 2008.

 

Outlook

 

We expect to use our cash, cash equivalents, credit facility and investments on working capital and general corporate purposes, the acquisition of businesses, products, product rights, or technologies, the settlement of outstanding litigation, the payment of contractual obligations, including scheduled interest payments on our convertible notes and regulatory or sales milestones that may become due, and/or the purchase, redemption or retirement of our convertible notes. However, we expect that sales of our currently marketed products should allow us to continue to generate positive operating cash flow in 2008. At this time, we cannot accurately predict the effect of certain developments on the rate of sales growth in 2009 and beyond, such as the degree of market acceptance, patent protection and exclusivity of our products, the impact of competition, the effectiveness of our sales and marketing efforts and the outcome of our current efforts to develop, receive approval for and successfully launch our near-term product candidates.

 

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As part of the U.S. Attorney’s Office settlement, in October 2008, we paid a total of $423.1 million plus $11.3 million interest, as set forth in Note 16 to our Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q.  The remaining settlement payments of $1.9 million plus interest related to the USAO settlement are expected to be paid in the fourth quarter.

 

Based on our current level of operations, projected sales of our existing products, and other revenues and interest income, we believe that we will be able to service our existing debt and meet our capital expenditure and working capital requirements in the near term. However, we cannot be sure that our anticipated revenue growth will be realized or that we will continue to generate significant positive cash flow from operations. We may need to obtain additional funding for future significant strategic transactions, to repay our outstanding indebtedness, particularly if such indebtedness is presented for conversion by holders (see “—Indebtedness” below), or for our future operational needs, and we cannot be certain that funding will be available on terms acceptable to us, or at all.

 

Marketed Products and Product Candidates

 

Continued sales growth of PROVIGIL depends, in part, on the continued effectiveness of the various settlement agreements we entered into in late 2005 and early 2006, as well as our maintenance of protection in the United States and abroad of the modafinil particle-size patent until at least 2012.  During 2007 and continuing in 2008, we experienced a decline in prescription growth of PROVIGIL that was more than offset by price increases.  Finally, growth of our modafinil-based product sales in the future may depend in part on our ability to successfully launch NUVIGIL in the second half of 2009.

 

The growth of our pain franchise depends in large part on our ability to successfully market FENTORA within its current indication and to secure FDA approval of a broader labeled indication for the product outside of breakthrough cancer pain.  November 2007, we submitted a supplemental new drug application (“sNDA”) to the FDA seeking approval to market FENTORA for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions.  The FDA held an Advisory Committee meeting on May 6, 2008 to discuss the FENTORA sNDA.  At that meeting, the Advisory Committee voted not to recommend approval of the FENTORA sNDA.  On September 15, 2008, we received a complete response letter, in which the FDA requested that we implement and demonstrate the effectiveness of proposed enhancements to the current FENTORA risk management program.  Even if we successfully implement and demonstrate the effectiveness of our risk management program, we do not know whether the FDA will approve our request for an expanded label for FENTORA.  Growth of FENTORA sales also will depend on the strength of the patent covering the product, particularly in light of the ANDAs filed by Watson and Barr.  Sales of our other pain product, ACTIQ, have been meaningfully eroded by the launch of FENTORA and by generic competition since September 2006 and we expect this erosion will continue during 2008. In addition, sales of our own generic OTFC could be significantly impacted by the entrance into the market of additional generic OTFC products, which could occur at any time.

 

Our future growth also depends, in part, on our ability to achieve continued sales growth with AMRIX and TREANDA, which we launched in October 2007 and April 2008, respectively.  Growth of AMRIX sales will depend in part on the strength of the patent covering the product, particularly in light of the ANDAs filed by Mylan and Barr.

 

Clinical Studies

 

Over the past few years, we have incurred significant expenditures related to conducting clinical studies to develop new pharmaceutical products and exploring the utility of our existing products in treating disorders beyond those currently approved in their respective labels. In 2008 and 2009, we expect to continue to incur significant levels of research and development expenditures. We also expect to continue or begin a number of significant clinical programs including, among others: possible studies of TREANDA as a first-line treatment for NHL and for the treatment of multiple myeloma; a Phase 3 program evaluating CEP-701 for the treatment of acute myelogenous leukemia and other possible studies in patients with myeloproliferative disorder; and clinical programs with NUVIGIL focused on excessive sleepiness associated with jet lag disorder, traumatic brain injury, cancer related fatigue/tiredness, adjunctive treatment to atypical anti-psychotics in schizophrenia patients, and bi-polar depression. We may seek to mitigate the risk in, and expense of, our research and development programs by entering into collaborative arrangements with third parties. However, we intend to retain a portion of the commercial rights to these programs and, as a result, we still expect to spend significant funds on our share of the cost of these programs, including the costs of research, preclinical development, clinical research and manufacturing.

 

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Manufacturing, Selling and Marketing Efforts

 

During the fourth quarter of 2008, we expect to continue to incur significant expenditures associated with manufacturing, selling and marketing our products. We expect to continue in-process capital expenditure projects at our research and development facilities in France and West Chester, Pennsylvania.  We also expect to continue in the fourth quarter of 2008 a capital expenditure project related to the transfer of manufacturing activities from our facility in Eden Prairie, Minnesota to our facility in Salt Lake City, Utah; we expect this transfer to be completed by 2010 or 2011.  The aggregate amount of our sales and marketing expenses in 2008 is expected to be higher than that incurred in 2007, primarily as a result of higher expenses associated with our promotional efforts related to PROVIGIL and AMRIX and launch expenses associated with TREANDA and pre-launch expenses associated with NUVIGIL.

 

Over the past few years, we have been developing a manufacturing process for the active pharmaceutical ingredient in NUVIGIL that is more cost effective than our prior process of separating modafinil into armodafinil.  As a result of our plan to manufacture armodafinil in the future using this new process and our decision to launch NUVIGIL in the second half of 2009, we assessed the potential impact of these items on certain of our existing agreements to purchase modafinil.  Under these contracts, we have agreed to purchase minimum amounts of modafinil through 2012, with aggregate purchase commitments totaling $64.4 million as of September 30, 2008.  Based on our third quarter assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  We also are initiating a search for a potential acquiror of our manufacturing facility in Mitry-Mory, France where we produce modafinil.  As of September 30, 2008, we had $43.3 million of property and equipment related to the Mitry-Mory facility included on our balance sheet.  The resolution of these assessments could have a negative impact on our results of operations in future periods.

 

Indebtedness

 

We have significant indebtedness outstanding, consisting principally of indebtedness on convertible subordinated notes. The following table summarizes the principal terms of our most significant convertible subordinated notes outstanding as of September 30, 2008:

 

Security

 

Outstanding

 

Conversion 
Price

 

Redemption Rights and Obligations

 

 

 

(in millions)

 

 

 

 

 

2.0% Convertible Senior Subordinated Notes due June 2015 (the “2.0% Notes”)

 

$

820.0

 

$

46.70

*

Generally not redeemable by the holder prior to December 2014.

 

 

 

 

 

 

 

 

 

 

 

Zero Coupon Convertible Notes due June 2033, first putable June 15, 2010 (the “2010 Zero Coupon Notes”)

 

$

199.5

 

$

56.50

*

Redeemable on June 15, 2010 at either option of holder or us at a redemption price of 100.25% of the principal amount redeemed.

 

 


*                 Stated conversion prices as per the terms of the notes. However, each convertible note contains certain terms restricting a holder’s ability to convert the notes, including that a holder may only convert if the closing price of our stock on the day prior to conversion is higher than $56.04 or $67.80 with respect to the 2.0% Notes or the 2010 Zero Coupon Notes, respectively. For a more complete description of these notes, including the associated convertible note hedge, see Note 11 to our Consolidated Financial Statements included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2007.

 

As of September 30, 2008, our closing stock price was $77.49, and therefore, all of our notes were convertible as of September 30, 2008.  Under the terms of the indentures governing the notes, we are obligated to repay in cash the aggregate principal balance of any such notes presented for conversion. As of the filing date of this Quarterly Report on Form 10-Q, we do not have available cash, cash equivalents and investments sufficient to repay these convertible notes, if presented. In addition, there are no restrictions on our use of this cash and the cash available to repay indebtedness may decline over time. If we do not have sufficient funds available to repay any principal balance of notes presented for conversion, we will be required to raise additional funds. Because the financing markets may be unwilling to provide funding to us or may only be willing to provide funding on terms that we would consider unacceptable, we may not have cash available or be able to obtain funding to permit us to meet our repayment obligations, thus adversely affecting the market price for our securities.

 

All of our notes have been classified as current liabilities on our consolidated balance sheet as of September 30, 2008.  We believe that the share price of our common stock would have to significantly increase over the market price as of the filing date of this report before the fair value of our convertible notes would be less than the value of the common stock underlying the

 

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notes.  As such, we believe it is highly unlikely that holders of the 2.0% Notes or the 2010 Zero Coupon Notes, if the restricted conversion prices were met, would present significant amounts of such notes for conversion under the current terms. In the event that a significant conversion did occur, we believe that we have the ability to raise sufficient cash to repay the principal amounts due through a combination of utilizing our existing cash on hand, accessing our credit facility, raising money in the capital markets or selling our note hedge instruments for cash.

 

The annual interest payments on our convertible notes outstanding as of September 30, 2008 are $16.4 million, payable semi-annually on June 1 and December 1. In the future, we may agree to exchanges of the notes for shares of our common stock or debt, or may determine to use a portion of our existing cash on hand to purchase or retire all or a portion of the outstanding convertible notes.

 

Our 2.0% Notes and 2010 Zero Coupon Notes each are considered Instrument C securities as defined by EITF 90-19; therefore, these notes are included in the dilutive earnings per share calculation using the treasury stock method. Under the treasury stock method, we must calculate the number of shares issuable under the terms of these notes based on the average market price of our common stock during the period, and include that number in the total diluted shares figure for the period. At the time we sold our 2.0% Notes and 2010 Zero Coupon Notes we entered into convertible note hedge and warrant agreements that together are intended to have the economic effect of reducing the net number of shares that will be issued upon conversion of the notes by increasing the effective conversion price for these notes, from our perspective, to $67.92 and $72.08, respectively. However, from an accounting principles generally accepted in the United States of America (“U.S. GAAP”) perspective, Statement of Financial Accounting Standards (“SFAS”) No. 128, “Earnings Per Share” (“SFAS 128”) considers only the impact of the convertible notes and the warrant agreements; since the impact of the convertible note hedge agreements is always anti-dilutive, SFAS 128 requires that we exclude from the calculation of fully diluted shares the number of shares of our common stock that we would receive from the counterparties to these agreements upon settlement.

 

Under the treasury stock method, changes in the share price of our common stock can have a significant impact on the number of shares that we must include in the fully diluted earnings per share calculation. The following table provides examples of how changes in our stock price will require the inclusion of additional shares in the denominator of the fully diluted earnings per share calculation (“Total Treasury Stock Method Incremental Shares”). The table also reflects the impact on the number of shares we could expect to issue upon concurrent settlement of the convertible notes, the warrant and the convertible note hedge (“Incremental Shares Issued by Cephalon upon Conversion”):

 

Share Price

 

Convertible
Notes Shares

 

Warrant 
Shares

 

Total Treasury
Stock Method
Incremental 
Shares(1)

 

Shares Due to
Cephalon under
Note Hedge

 

Incremental 
Shares Issued by
Cephalon upon
Conversion(2)

 

$

65.00

 

5,406

 

 

5,406

 

(5,406

)

 

$

75.00

 

7,498

 

1,998

 

9,496

 

(7,498

)

1,998

 

$

85.00

 

9,097

 

4,496

 

13,593

 

(9,097

)

4,496

 

$

95.00

 

10,359

 

6,468

 

16,827

 

(10,359

)

6,468

 

$

105.00

 

11,381

 

8,065

 

19,446

 

(11,381

)

8,065

 

 


(1)

 

Represents the number of incremental shares that must be included in the calculation of fully diluted shares under U.S. GAAP.

 

 

 

(2)

 

Represents the number of incremental shares to be issued by us upon conversion of the convertible notes, assuming concurrent settlement of the convertible note hedges and warrants.

 

On August 15, 2008, we established a $200 million, three-year revolving credit facility with JP Morgan Chase Bank, N.A. and certain other lenders.  The credit facility is available for letters of credit, working capital and general corporate purposes and is guaranteed by certain of our domestic subsidiaries.  The credit agreement contains standard covenants, including but not limited to covenants related to total debt to Consolidated EBITDA (as defined in the credit agreement), senior debt to Consolidated EBITDA, interest expense coverage and limitations on capital expenditures, asset sales, mergers and acquisitions, indebtedness, liens, and transactions with affiliates.  As of the date of this filing, we have not drawn any amounts under the credit facility.

 

Acquisition Strategy

 

As part of our business strategy, we plan to consider and, as appropriate, make acquisitions of other businesses, products, product rights or technologies. Our cash reserves and other liquid assets may be inadequate to consummate such

 

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acquisitions and it may be necessary for us to access our $200 million credit facility or to issue stock or raise substantial additional funds in the future to complete future transactions. In addition, as a result of our acquisition efforts, we are likely to experience significant charges to earnings for merger and related expenses (whether or not our efforts are successful) that may include transaction costs, closure costs or acquired in-process research and development charges.

 

Other

 

We may experience significant fluctuations in quarterly results based primarily on the level and timing of:

 

·

 

cost of product sales;

 

 

 

·

 

achievement and timing of research and development milestones;

 

 

 

·

 

collaboration revenues;

 

 

 

·

 

cost and timing of clinical trials, regulatory approvals and product launches;

 

 

 

·

 

marketing and other expenses;

 

 

 

·

 

manufacturing or supply disruptions;

 

 

 

·

 

unanticipated conversions of our convertible notes; and

 

 

 

·

 

costs associated with the operations of recently-acquired businesses and technologies.

 

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

 

(In thousands)

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses our consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States of America. In preparing these financial statements, we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. A summary of significant accounting policies and a description of accounting policies that are considered critical may be found in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2007 in the “Critical Accounting Policies and Estimates” section and the “Recent Accounting Pronouncements” section.

 

Product Sales Allowances—We record product sales net of the following significant categories of product sales allowances, each of which is described in more detail included in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2007: prompt payment discounts, wholesaler discounts, returns, coupons, Medicaid discounts, Medicare Part D discounts and managed care and governmental contracts. Calculating each of these items involves significant estimates and judgments and requires us to use information from external sources. In certain of the product sales allowance categories, we have calculated the impact of changes in our estimates, which we believe represent reasonably likely changes to these estimates based on historical data adjusted for certain unusual items such as changes in government contract rules.

 

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The following table summarizes activity in each of the above categories for the nine months ended September 30, 2008:

 

(In thousands)

 

Prompt 
Payment 
Discounts

 

Wholesaler
Discounts

 

Returns*

 

Coupons

 

Medicaid 
Discounts

 

Managed 
Care &
Governmental
Contracts

 

Total

 

Balance at
January 1, 2008

 

$

(3,082

)

$

(6,449

)

$

(25,335

)

$

(7,253

)

$

(19,883

)

$

(24,264

)

$

(86,266

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(26,176

)

(5,912

)

(12,888

)

(16,478

)

(29,165

)

(88,194

)

(178,813

)

Prior periods

 

 

2

 

(13,954

)

108

 

(149

)

1,375

 

(12,618

)

Total

 

(26,176

)

(5,910

)

(26,842

)

(16,370

)

(29,314

)

(86,819

)

(191,431

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actual:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

22,325

 

5,885

 

 

10,459

 

5,625

 

47,665

 

91,959

 

Prior periods

 

3,082

 

6,447

 

22,505

 

7,144

 

19,545

 

22,892

 

81,615

 

Total

 

25,407

 

12,332

 

22,505

 

17,603

 

25,170

 

70,557

 

173,574

 

Balance at
September 30, 2008

 

$

(3,851

)

$

(27

)

$

(29,672

)

$

(6,020

)

$

(24,027

)

$

(40,526

)

$

(104,123

)

 


*                    Given our return goods policy, we assume that all returns in a current year relate to prior period sales.

 

Product Sales Allowances- Returns-  Customers can return short-dated or expired product that meets the guidelines set forth in our return goods policy. Product shelf life from the date of manufacture for PROVIGIL is three years, GABITRIL is two to three years, depending on product strength, and ACTIQ, TREANDA, AMRIX and FENTORA are each two years. Returns are accepted from wholesalers and retail pharmacies. Wholesaler customers can return short-dated product with six months or less shelf life remaining and expired product within twelve months following the expiration date. Retail pharmacies are not permitted to return short-dated product but can return full or partial quantities of expired product only within twelve months following the expiration date. We base our estimates of product returns for each of our products on the percentage of returns that we have experienced historically. Notwithstanding this, we may adjust our estimate of product returns if we are aware of other factors that we believe could meaningfully impact our expected return percentages. These factors could include, among others, our estimates of inventory levels of our products in the distribution channel, known sales trends and existing or anticipated competitive market forces such as product entrants and/or pricing changes.

 

For the nine months ended September 30, 2008, we recorded a provision for returns at a weighted average rate of 1.7% of gross sales, which is 1.0% increase over our actual historical return percentages. Between March and July of 2006, we increased ACTIQ manufacturing levels to ensure sufficient supply as we switched manufacturing to FENTORA in anticipation of its launch and prepared for the transition of ACTIQ production to a new facility that opened in August 2006.  The expiration of this product in the third quarter of 2008 has resulted in increased returns.  We believe that the returns in the third quarter of 2008 are not indicative of future periods and therefore we have not adjusted our returns percentage as it relates to current ACTIQ sales.  In the future, actual returns could exceed historical experience and our estimates of expected future returns activity because of several factors, including, among other things, wholesaler and retailer stocking patterns and/or competition. If the returns provision percentage were to increase by 1.0% of 2008 year-to-date gross sales from our proprietary products marketed in the U.S., then an additional provision of $12.6 million would result.

 

Valuation of Property and Equipment, Intangible Assets, Goodwill and Investments—Our property and equipment have been recorded at cost and are being depreciated on a straight-line basis over the estimated useful life of those assets.

 

We regularly assess our property and equipment, intangible assets, goodwill and other long lived assets to determine whether any impairment in these assets may exist and, if so, the extent of such impairment. To do this, in the case of goodwill, we estimate the fair value of each of our reporting units and compare it to the book value of their net assets. In the case of intangibles and other long lived assets, we assess whether triggering events have occurred and if so, we compare the estimated cash flows of the related asset group and compare it to the book value of the asset group. Calculating fair value as well as future cash flows requires that we make a number of critical legal, economic, market and business assumptions that reflect our best estimates as of the testing date. We believe the methods we use to determine these underlying assumptions and estimates are reasonable and reflective of common practice. Notwithstanding this, our assumptions and estimates may differ significantly

 

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from actual results, or circumstances could change that would cause us to conclude that an impairment now exists or that we previously understated the extent of impairment.

 

With respect to VIVITROL, we currently have $91.7 million of intangible assets and $33.2 million of construction in progress assets as of September 30, 2008.  The carrying value of these assets is supported by our projections for future revenue growth of VIVITROL.  To date, actual revenue has not met our initial estimates. If actual future revenue growth of the product continues to be materially less than our initial projections, we may conclude that the VIVITROL intangible assets and the construction in progress assets are impaired.  For additional information regarding our significant accounting policies with respect to goodwill, intangibles and other long-lived assets, see Note 1 of our Consolidated Financial Statements included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2007.

 

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ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are exposed to foreign currency exchange risk related to our operations in European subsidiaries that have transactions, assets, and liabilities denominated in foreign currencies that are translated into U.S. dollars for consolidated financial reporting purposes. Historically, we have not hedged any of these foreign currency exchange risks. For the three months ended September 30, 2008, an average 10% weakening of the U.S. dollar relative to the currencies in which our European subsidiaries operate would have resulted in an increase of $9.3 million in reported total revenues and an equivalent increase in reported expenses. This sensitivity analysis of the effects of changes in foreign currency exchange rates does not assume any changes in the level of operations of our European subsidiaries.

 

Our exposure to market risk for a change in interest rates relates to our investment portfolio, since all of our outstanding debt is fixed rate. Our investments are classified as short-term and as “available for sale.” We do not believe that short-term fluctuations in interest rates would materially affect the value of our securities.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

(a)  Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report have been designed and are functioning effectively to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. We believe that a controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

 

(b)  Change in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during our most recent 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

 

The information required by this Item is incorporated by reference to Note 11 of the Consolidated Financial Statements included in Part I, Item 1 of this Report.

 

ITEM 1A.  RISK FACTORS

 

You should carefully consider the risks described below, in addition to the other information contained in this report, before making an investment decision. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.

 

A significant portion of our revenue is derived from our three largest products, and our future success will depend on the continued acceptance of PROVIGIL and FENTORA, the growth of AMRIX and TREANDA and the ability to successfully launch NUVIGIL.

 

For the nine months ended September 30, 2008, approximately 50%, 15% and 8% of our total consolidated net sales were derived from sales of PROVIGIL, ACTIQ (including our generic OTFC product) and FENTORA, respectively. With respect to PROVIGIL, we cannot be certain that it will continue to be accepted in its market.  In September 2006, Barr entered the market with generic OTFC.  Since that time, we have experienced meaningful erosion of branded ACTIQ sales in the United States and we expect this erosion will continue during the remainder of 2008. In addition, sales of our own generic

 

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OTFC product could be significantly impacted by the entrance into the market of additional generic OTFC products, which could occur at any time.  With respect to NUVIGIL, which we currently intend to launch in the second half of 2009, we cannot be sure that our sales and marketing efforts will be successful or that it will be accepted in the market.

 

To counter the impact from existing and potential generic competition, we will need FENTORA, our next-generation pain product launched in October 2006, to continue to be accepted in the market.  In September 2007, we issued a letter to healthcare professionals to clarify the appropriate patient selection, dosage and administration for FENTORA, following reports of serious adverse events in connection with the use of the product.  We also are working with FDA and expect to implement COVERS™, a new risk management program for FENTORA intended to ensure appropriate prescribing and use of this product.  It is possible that this program could have a negative impact on FENTORA prescription growth.  If FDA recommends that a similar program be applied to ACTIQ and generic OTFC, it is possible that prescriptions of these products also could be impacted.

 

For sales to grow over the next several years, we will need our two newest products, AMRIX and TREANDA, to achieve projected levels of growth.  Specifically, the following factors, among others, could affect the level of market acceptance of these products, as well as PROVIGIL, FENTORA, and ACTIQ:

 

·

 

a change in the perception of the healthcare community of the safety and efficacy of the products, both in an absolute sense and relative to that of competing products;

 

 

 

·

 

the level and effectiveness of our sales and marketing efforts;

 

 

 

·

 

the extent to which the products are studied in clinical trials in the future and the results of any such studies;

 

 

 

·

 

any unfavorable publicity regarding these or similar products;

 

 

 

·

 

the price of the products relative to other competing drugs or treatments, including the impact of the availability of generic OTFC products on market acceptance of FENTORA;

 

 

 

·

 

any changes in government and other third-party payer reimbursement policies and practices; and

 

 

 

·

 

regulatory developments affecting the manufacture, marketing or use of these products.

 

Any adverse developments with respect to the sale or use of these products could significantly reduce our product revenues and have a material adverse effect on our ability to generate net income and positive net cash flow from operations.

 

We may be unsuccessful in our efforts to obtain regulatory approval for new products or for new formulations of our existing products, which would significantly hamper future sales and earnings growth.

 

Our long-term prospects, particularly with respect to the growth of our future sales and earnings, depend to a large extent on our ability to obtain FDA approvals of new product candidates or of expanded indications of our existing products such as FENTORA and NUVIGIL. On May 6, 2008, a Joint Advisory Committee to the FDA voted not to recommend approval of an expanded label for FENTORA for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions.  On September 15, 2008, we received a complete response letter, in which the FDA requested that we implement and demonstrate the effectiveness of proposed enhancements to the current FENTORA risk management program.  We are continuing to work with FDA and expect to implement COVERS™, a new risk management program for FENTORA that is intended to ensure appropriate prescribing and use of this product and to provide a potential avenue for approval of the FENTORA sNDA.  There can be no assurance that our applications to market these and other product candidates will be submitted or reviewed in a timely manner or that the FDA will approve the product candidates on the basis of the data contained in the applications.  Even if approval is granted to market a product candidate, there can be no assurance that we will be able to successfully commercialize the product in the marketplace or achieve a profitable level of sales.

 

We may not be able to maintain adequate protection for our intellectual property or market exclusivity for our key products and, therefore, competitors may develop competing products, which could result in a decrease in sales and market share, cause us to reduce prices to compete successfully and limit our commercial success.

 

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We place considerable importance on obtaining patent protection for new technologies, products and processes. To that end, we file applications for patents covering the compositions or uses of our drug candidates or our proprietary processes. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal, scientific and factual questions. Accordingly, the patents and patent applications relating to our products, product candidates and technologies may be challenged, invalidated or circumvented by third parties and might not protect us against competitors with similar products or technology. Patent disputes in our industry are frequent and can preclude commercialization of products. If we ultimately engage in and lose any such disputes, we could be subject to competition or significant liabilities, we could be required to enter into third party licenses or we could be required to cease using the technology or product in dispute. In addition, even if such licenses are available, the terms of any license requested by a third party could be unacceptable to us.

 

We also rely on trade secrets, know-how and continuing technological advancements to support our competitive position. Although we have entered into confidentiality and invention rights agreements with our employees, consultants, advisors and collaborators, these parties could fail to honor such agreements or we could be unable to effectively protect our rights to our unpatented trade secrets and know-how. Moreover, others could independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets and know-how. In addition, many of our scientific and management personnel have been recruited from other biotechnology and pharmaceutical companies where they were conducting research in areas similar to those that we now pursue. As a result, we could be subject to allegations of trade secret violations and other claims.

 

PROVIGIL / NUVIGIL

 

The U.S. composition of matter patent for modafinil expired in 2001. We own U.S. and foreign patent rights that expire between 2014 and 2015 and cover pharmaceutical compositions and uses of modafinil, specifically, certain particle sizes of modafinil contained in the pharmaceutical composition of PROVIGIL. With respect to NUVIGIL, we successfully obtained issuance of a U.S. patent in November 2006 claiming the Form I polymorph of armodafinil, the active drug substance in NUVIGIL.  This patent is currently set to expire in 2023.  Foreign patent applications directed to the Form I polymorph of armodafinil and its use in treating sleep disorders are pending in Europe and elsewhere. Ultimately, these patents might be found invalid as the result of a challenge by a third party, or a potential competitor could develop a competing product or product formulation that avoids infringement of these patents. While we intend to vigorously defend the validity of these patents and prevent infringement, these efforts will be both expensive and time consuming and, ultimately, may not be successful. The loss of patent protection for our modafinil-based products would significantly and negatively impact future sales.

 

As of the filing date of this Quarterly Report on Form 10-Q, we are aware of seven ANDAs on file with the FDA for pharmaceutical products containing modafinil. Each of these ANDAs contains a Paragraph IV certification in which the ANDA applicant certified that the U.S. particle-size modafinil patent covering PROVIGIL either is invalid or will not be infringed by the ANDA product. In March 2003, we filed a patent infringement lawsuit against four companies — Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals, Inc., Ranbaxy Laboratories Limited and Barr Laboratories, Inc. — based upon the ANDAs filed by each of these companies with the FDA seeking approval to market a generic form of modafinil. We believe that these four companies were the first to file ANDAs with Paragraph IV certifications and thus are eligible for the 180-day period of marketing exclusivity provided by the provisions of the Federal Food, Drug and Cosmetic Act.  In early 2005, we also filed a patent infringement lawsuit against Carlsbad Technology, Inc. based upon the Paragraph IV ANDA related to modafinil that Carlsbad filed with the FDA.

 

In late 2005 and early 2006, we entered into settlement agreements with each of Teva, Mylan, Ranbaxy and Barr; in August 2006, we entered into a settlement agreement with Carlsbad and its development partner, Watson Pharmaceuticals, Inc., which we understand has the right to commercialize the Carlsbad product if approved by the FDA. As part of these separate settlements, we agreed to grant to each of these parties a non-exclusive royalty-bearing license to market and sell a generic version of PROVIGIL in the United States, effective in April 2012, subject to applicable regulatory considerations. Under the agreements, the licenses could become effective prior to April 2012 only if a generic version of PROVIGIL is sold in the United States prior to this date.

 

We filed each of the settlements with both the FTC and the Antitrust Division of the DOJ as required by the Medicare Modernization Act. The FTC conducted an investigation of each of the PROVIGIL settlements and, in February 2008, filed suit against us in U.S. District Court for the District of Columbia challenging the validity of the settlements and related agreements entered into by us with each of Teva, Mylan, Ranbaxy and Barr.  We filed a motion to transfer the case to

 

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the U.S. District Court for the Eastern District of Pennsylvania, which was granted in April 2008.  The complaint alleges a violation of Section 5(a) of the Federal Trade Commission Act and seeks to permanently enjoin us from maintaining or enforcing these agreements and from engaging in similar conduct in the future.  We believe the FTC complaint is without merit and have filed a motion to dismiss the case.  While we intend to vigorously defend ourselves and the propriety of the settlement agreements, these efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

We also are aware of numerous private antitrust complaints filed in the U.S. District Court for the Eastern District of Pennsylvania, each naming Cephalon, Barr, Mylan, Teva and Ranbaxy as co-defendants and claiming, among other things, that the PROVIGIL settlements violate the antitrust laws of the United States and, in some cases, certain state laws. All but one of these actions have been consolidated into a complaint on behalf of a class of direct purchasers of PROVIGIL and a separate complaint on behalf of a class of consumers and other indirect purchasers of PROVIGIL. A separate complaint filed by an indirect purchaser of PROVIGIL was filed in September 2007. The plaintiffs in all of these actions are seeking monetary damages and/or equitable relief. We moved to dismiss the class action complaints in November 2006.

 

Separately, in June 2006, Apotex, Inc., a subsequent ANDA filer seeking FDA approval of a generic form of modafinil, filed suit against us, also in the U.S. District Court for the Eastern District of Pennsylvania, alleging similar violations of antitrust laws and state law. Apotex asserts that the PROVIGIL settlement agreements improperly prevent it from obtaining FDA approval of its ANDA, and seeks monetary and equitable remedies. Apotex also seeks a declaratory judgment that the ‘516 Patent is invalid, unenforceable and/or not infringed by its proposed generic. In late 2006, we filed a motion to dismiss the Apotex case, which is pending. Separately, in April 2008, the Federal Court of Canada dismissed our application to prevent regulatory approval of Apotex’s generic modafinil tablets in Canada.  We have learned that Apotex has launched its generic modafinil tablets in Canada, and we intend to initiate a patent infringement lawsuit against Apotex.  We believe that the private antitrust complaints described in the preceding paragraph and the Apotex antitrust complaint are without merit. While we intend to vigorously defend ourselves and the propriety of the settlement agreements, these efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

In November 2005 and March 2006, we received notice that Caraco Pharmaceutical Laboratories, Ltd. and Apotex, Inc., respectively, also filed Paragraph IV ANDAs with the FDA in which each firm is seeking to market a generic form of PROVIGIL. We have not filed patent infringement lawsuits against either Caraco or Apotex as of the filing date of this report, although Apotex has filed suit against us, as described above.  In early August 2008, we received notice that Hikma Pharmaceuticals filed a Paragraph IV ANDA with the FDA in which it is seeking to market a generic form of PROVIGIL. We have not filed a patent infringement lawsuit against Hikma Pharmaceuticals as of the filing date of this report.

 

DURASOLV

 

In the third quarter of 2007, the PTO notified us that, on re-examination, it has rejected the claims in the two U.S. patents for our DURASOLV ODT technology.  We have filed notices of appeal of the PTO’s decisions.  While we intend to vigorously defend these patents, these efforts, ultimately, may not be successful.  The invalidity of the DURASOLV patents could have an adverse impact on revenues from our drug delivery business.

 

FENTORA

 

In April 2008 and June 2008, we received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Watson Laboratories, Inc. and Barr Laboratories, Inc., respectively, requesting approval to market and sell a generic equivalent of FENTORA.  Both Watson and Barr allege that our U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the product described in their respective ANDAs.  The 6,200,604 and 6,974,590 patents cover methods of use for FENTORA and do not expire until 2019.  In June 2008 and July 2008, we and our wholly-owned subsidiary, CIMA LABS INC., filed lawsuits in U.S. District Court in Delaware against Watson and Barr for infringement of these patents.  Under the provisions of the Hatch-Waxman Act, the filing of these lawsuits stays any FDA approval of each ANDA until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the date of our receipt of the respective Paragraph IV certification letter.

 

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AMRIX

 

In October 2008, we, together with our partner, Eurand NV, received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan and Barr, each requesting approval to market and sell a generic equivalent of AMRIX.  Mylan alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or unenforceability of the Eurand patent.  Barr alleges that Eurand’s U.S. Patent Number 7,387,793 covering AMRIX is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.  The 7,387,793 patent covers extended-release formulations containing cyclobenzaprine and does not expire until February 26, 2025.  Eurand and Cephalon currently are reviewing the respective letters and, by statute, Eurand, as patent holder, has 45 days to initiate a patent infringement lawsuit against Mylan and/or Barr.  Such a lawsuit would automatically prevent the FDA from approving the Mylan ANDA and/or the Barr ANDA, as the case may be, until the earlier of a district court decision or 30 months from our receipt of the applicable letter. Eurand and Cephalon have not filed a patent infringement lawsuit against either Mylan or Barr as of the filing date of this report. While we, working with Eurand, intend to vigorously defend the AMRIX intellectual property rights, these efforts, ultimately, may not be successful.

 

Our activities and products are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply.

 

We currently have a number of products that have been approved for sale in the United States, foreign countries or both. All of our approved products are subject to extensive continuing regulations relating to, among other things, testing, manufacturing, quality control, labeling, and promotion. The failure to comply with any rules and regulations of the FDA or any foreign medical authority, or the post-approval discovery of previously unknown problems relating to our products, could result in, among other things:

 

·        fines, recalls or seizures of products;

 

·        total or partial suspension of manufacturing or commercial activities;

 

·        non-approval of product license applications;

 

·        restrictions on our ability to enter into strategic relationships; and

 

·        criminal prosecution.

 

Over the past few years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities, including the DOJ and various U.S. Attorney’s Offices, the Office of Inspector General of the Department of Health and Human Services, the FDA, the FTC and various state Attorneys General offices.  These investigations have alleged violations of various federal and state laws and regulations, including claims asserting antitrust violations, violations of the Food, Drug and Cosmetic Act, the False Claims Act, the Prescription Drug Marketing Act, anti-kickback laws, and other alleged violations in connection with off-label promotion of products, pricing and Medicare and/or Medicaid reimbursement.

 

Because of the broad scope and complexity of these laws and regulations, the high degree of prosecutorial resources and attention being devoted to the sales practices of pharmaceutical companies by law enforcement authorities, and the risk of potential exclusion from federal government reimbursement programs, numerous companies have determined that it is highly advisable that they enter into settlement agreements in these matters, particularly those brought by federal authorities.  Companies that have chosen to settle these alleged violations have typically paid multi-million dollar fines to the government and agreed to abide by corporate integrity agreements.

 

In early November 2007, we announced that we had reached an agreement in principle with the U.S. Attorney’s Office (“USAO”) in Philadelphia and the DOJ with respect to the USAO investigation that began in September 2004. On September 29, 2008, to finalize our previously announced agreement in principle, we entered into a settlement agreement (the “Settlement Agreement”) with the DOJ, the USAO, the Office of Inspector General of the Department of Health and Human Services (“OIG”), TRICARE Management Activity, the U.S. Office of Personnel Management (collectively, the “United States”) and the relators identified in the Settlement Agreement (the “Relators”) to settle the outstanding False Claims Act claims alleging off-label promotion of ACTIQ and PROVIGIL from January 1, 2001 through December 31, 2006 and GABITRIL from January 2, 2001 through February 18, 2005 (the “Claims”). As part of the Settlement Agreement we agreed to pay a total of $375 million (the “Payment”) plus interest of $11.3 million. We also agreed to pay the Relators’ attorneys’ fees. Pursuant to the Settlement Agreement, the United States and the Relators released us from all Claims and the United States agreed to refrain from seeking our exclusion from Medicare/Medicaid, the TRICARE Program or other federal health care programs. In connection with the Settlement Agreement, we pled guilty to one misdemeanor violation of the U.S. Food, Drug and Cosmetic Act and agreed to pay $50 million (in addition to the Payment), of which $40 million applied to a criminal fine and $10 million applied to satisfy the forfeiture obligation.

 

As part of the Settlement Agreement, we entered into a five-year Corporate Integrity Agreement (the “CIA”) with the OIG. The CIA provides criteria for establishing and maintaining compliance. We are also subject to periodic reporting and certification requirements attesting that the provisions of the CIA are being implemented and followed. We also agreed to enter into a State Settlement and Release Agreement (the “State Settlement Agreement”) with each of the 50 states and the District of Columbia. Upon entering into the State Settlement Agreement, a state will receive its portion of the Payment allocated for the compensatory state Medicaid payments and related interest amounts. Each state also agrees to refrain from seeking our exclusion from its Medicaid program.

 

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On September 29, 2008, we also announced that we had entered into an Assurance of Voluntary Compliance (the “Connecticut Assurance”) with the Attorney General of the State of Connecticut and the Commissioner of Consumer Protection of the State of Connecticut (collectively, “Connecticut”) to settle Connecticut’s investigation of our promotion of ACTIQ, GABITRIL and PROVIGIL. Pursuant to the Connecticut Assurance, (i) we agreed to pay a total of $6.15 million to Connecticut, of which $3.8 million will fund Connecticut Department of Public Health cancer initiatives and $0.2 million will fund a state electronic prescription monitoring program; and (ii) Connecticut released us from any claim relating to the promotional practices that were the subject of Connecticut’s investigation. On the same date we also entered into an Assurance of Discontinuance (the “Massachusetts Settlement Agreement”) with the Attorney General of the Commonwealth of Massachusetts (“Massachusetts”) to settle Massachusetts’ investigation of our promotional practices with respect to fentanyl-based products. Pursuant to the Massachusetts Settlement Agreement, (i) we agreed to pay a total of $0.7 million to Massachusetts, of which $0.45 million will fund Massachusetts cancer initiatives and benefit consumers in Massachusetts; and (ii) Massachusetts released us from any claim relating to the promotional practices that were the subject of Massachusetts’ investigation.

 

Although we have resolved the previously outstanding federal and state government investigations into our sales and promotional practices, we cannot rule out regulatory or other actions by governmental entities who are not party to the settlement agreements we have entered.  We may also become subject to claims by private parties with respect to the alleged conduct which was the subject of our settlements with the federal and state governmental entities.  In addition, while we intend to comply fully with the terms of the settlement agreements, the settlement agreements provide for sanctions and penalties for violations of specific provisions therein. We cannot predict when or if any such actions may occur or reasonably estimate the amount of any fines, penalties, or other payments or the possible effect of any non-monetary restrictions that might result from either settlement of, or an adverse outcome from, any such actions.    Further, while we have initiated, and will initiate, compliance programs to prevent conduct similar to the alleged conduct subject to these agreements, we cannot provide complete assurance that conduct similar to the alleged conduct will not occur in the future, subjecting Cephalon to future claims and actions.  Failure to comply with the terms of the CIA could result in, among other things, substantial civil penalties and/or our exclusion from government health care programs, which could materially reduce our sales and adversely affect our financial condition and results of operations.

 

In late 2007, we were served with a series of putative class action complaints filed on behalf of entities that claim to have purchased ACTIQ for uses outside of the product’s approved label in non-cancer patients.  The complaints allege violations of various state consumer protection laws, as well as the violation of the common law of unjust enrichment, and seek an unspecified amount of money in actual, punitive and/or treble damages, with interest, and/or disgorgement of profits.  In May 2007, the plaintiffs filed a consolidated and amended complaint that also allege violations of RICO and conspiracy to violate RICO.  We believe the allegations in the complaint are without merit, and we intend to vigorously defend ourselves in these matters and in any similar actions that may be filed in the future.  These efforts will be both expensive and time consuming and, ultimately, due to the nature of litigation, there can be no assurance that these efforts will be successful.

 

In March 2007 and March 2008, we received letters requesting information related to ACTIQ and FENTORA from Congressman Henry A. Waxman in his capacity as Chairman of the House Committee on Oversight and Government Reform.  The letters request information concerning our sales, marketing and research practices for ACTIQ and FENTORA, among other things.  We are cooperating with these requests and are continuing to provide documents and other information to the Committee.

 

It is both costly and time-consuming for us to comply with these inquiries and with the extensive regulations to which we are subject. Additionally, incidents of adverse drug reactions, unintended side effects or misuse relating to our products could result in additional regulatory controls or restrictions, or even lead to withdrawal of a product from the market.

 

With respect to our product candidates, we conduct research, preclinical testing and clinical trials, each of which requires us to comply with extensive government regulations. We cannot market these product candidates or these new indications in the United States or other countries without receiving approval from the FDA or the appropriate foreign medical authority. The approval process is highly uncertain and requires substantial time, effort and financial resources.

 

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Ultimately, we may never obtain approval in a timely manner, or at all. Without these required approvals, our ability to substantially grow revenues in the future could be adversely affected.

 

In addition, because PROVIGIL, NUVIGIL, FENTORA, ACTIQ and generic OTFC contain active ingredients that are controlled substances, we are subject to regulation by the U.S. Drug Enforcement Agency (“DEA”) and analogous foreign organizations relating to the manufacture, shipment, sale and use of the applicable products. These regulations also are imposed on prescribing physicians and other third parties, making the storage, transport and use of such products relatively complicated and expensive. With the increased concern for safety by the FDA and the DEA with respect to products containing controlled substances and the heightened level of media attention given to this issue, it is possible that these regulatory agencies could impose additional restrictions on marketing or even withdraw regulatory approval for such products. In addition, adverse publicity may bring about a rejection of the product by the medical community. If the DEA, FDA or analogous foreign authorities withdrew the approval of, or placed additional significant restrictions on the marketing of any of our products, our ability to promote our products and product sales could be substantially affected.

 

We rely on third parties for the timely supply of specified raw materials, equipment, contract manufacturing, formulation or packaging services, product distribution services, customer service activities and product returns processing. Although we actively manage these third party relationships to ensure continuity and quality, some events beyond our control could result in the complete or partial failure of these goods and services. Any such failure could have a material adverse effect on our financial condition and result of operations.

 

Manufacturing, supply and distribution problems may create supply disruptions that could result in a reduction of product sales revenue and an increase in costs of sales, and damage commercial prospects for our products.

 

The manufacture, supply and distribution of pharmaceutical products, both inside and outside the United States, is highly regulated and complex. We, and the third parties we rely upon for the manufacturing and distribution of our products, must comply with all applicable regulatory requirements of the FDA and foreign authorities, including current Good Manufacturing Practice regulations.

 

We also must comply with all applicable regulatory requirements of the DEA and analogous foreign authorities for certain of our products that contain controlled substances. The DEA also has authority to grant or deny requests for quota of controlled substances such as the fentanyl that is the active ingredient in FENTORA or fentanyl citrate that is the active ingredient in ACTIQ and generic OTFC. Under our license and supply agreement with Barr, we are obligated to sell generic OTFC to Barr for its resale in the United States. Depending on sales volumes and our ability to obtain additional quota from the DEA, we could face shortages of quota in the future that could negatively impact our ability to supply product to Barr or to produce ACTIQ or our generic OTFC product.  If we are unable to provide product to Barr, it is possible that either Barr or the FTC could claim that such a failure would constitute a breach of our agreements with these parties.

 

The facilities used to manufacture, store and distribute our products also are subject to inspection by regulatory authorities at any time to determine compliance with regulations. These regulations are complex, and any failure to comply with them could lead to remedial action, civil and criminal penalties and delays in production or distribution of material.

 

For certain of our products in the United States and abroad, we depend upon single sources for the manufacture of both the active drug substances contained in our products and for finished commercial supplies. The process of changing or adding a manufacturer or changing a formulation requires prior FDA and/or analogous foreign medical authority approval and is very time-consuming. If we are unable to manage this process effectively or if an unforeseen event occurs at any facility, we could face supply disruptions that would result in significant costs and delays, undermine goodwill established with physicians and patients, damage commercial prospects for our products and adversely affect operating results.

 

As our products are used commercially, unintended side effects, adverse reactions or incidents of misuse may occur that could result in additional regulatory controls, changes to product labeling, adverse publicity and reduced sales of our products.

 

During research and development, the use of pharmaceutical products, such as ours, is limited principally to clinical trial patients under controlled conditions and under the care of expert physicians. The widespread commercial use of our products could identify undesirable or unintended side effects that have not been evident in our clinical trials or the commercial use as of the filing date of this report. For example, in September 2007, we issued a letter to healthcare professionals to clarify the appropriate patient selection, design and administration for FENTORA, following reports of

 

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serious adverse events in connection with the use of the product.  Likewise, in February 2005, working with the FDA, we updated our prescribing information for GABITRIL to include a bolded warning describing the risk of new onset seizures in patients without epilepsy. In addition, in patients who take multiple medications, drug interactions could occur that can be difficult to predict. Additionally, incidents of product misuse, product diversion or theft may occur, particularly with respect to products such as FENTORA, ACTIQ, generic OTFC and PROVIGIL, which contain controlled substances.

 

These events, among others, could result in adverse publicity that harms the commercial prospects of our products or lead to additional regulatory controls that could limit the circumstances under which the product is prescribed or even lead to the withdrawal of the product from the market. In particular, FENTORA and ACTIQ have been approved under regulations concerning drugs with certain safety profiles, under which the FDA has established special restrictions to ensure safe use. Any violation of these special restrictions could lead to the imposition of further restrictions or withdrawal of the product from the market.

 

We face significant product liability risks, which may have a negative effect on our financial performance.

 

The administration of drugs to humans, whether in clinical trials or commercially, can result in product liability claims whether or not the drugs are actually at fault for causing an injury. Furthermore, our products may cause, or may appear to have caused, adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug has been administered to patients for some time. As our products are used more widely and in patients with varying medical conditions, the likelihood of an adverse drug reaction, unintended side effect or incidence of misuse may increase. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a negative effect on our financial performance. The cost of product liability insurance has increased in recent years, and the availability of coverage has decreased. Nevertheless, we maintain product liability insurance and significant self-insurance retentions in amounts we believe to be commercially reasonable but which would be unlikely to cover the potential liability associated with a significant unforeseen safety issue. Any claims could easily exceed our current coverage limits. Even if a product liability claim is not successful, the adverse publicity and time and expense of defending such a claim may interfere with our business.

 

Our product sales and related financial results will fluctuate, and these fluctuations may cause our stock price to fall, especially if investors do not anticipate them.

 

A number of analysts and investors who follow our stock have developed models to attempt to forecast future product sales and expenses, and have established earnings expectations based upon those models. These models, in turn, are based in part on estimates of projected revenue and earnings that we disclose publicly. Forecasting future revenues is difficult, especially when we only have a few years of commercial history and when the level of market acceptance of our products is changing rapidly. As a result, it is reasonably likely that our product sales will fluctuate to an extent that may not meet with market expectations and that also may adversely affect our stock price. There are a number of other factors that could cause our financial results to fluctuate unexpectedly, including:

 

·        cost of product sales;

 

·        achievement and timing of research and development milestones;

 

·        collaboration revenues;

 

·        cost and timing of clinical trials, regulatory approvals and product launches;

 

·        marketing and other expenses;

 

·        manufacturing or supply disruptions;

 

·        unanticipated conversion of our convertible notes; and

 

·        costs associated with the operations of recently-acquired businesses and technologies.

 

We may be unable to repay our substantial indebtedness and other obligations.

 

All of our convertible notes outstanding contain restricted conversion prices that are either below or close to our stock price as of September 30, 2008. As a result, certain of our convertible notes have been classified as current liabilities on our consolidated balance sheet at September 30, 2008. Under the terms of the indentures governing the notes, we are

 

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obligated to repay in cash the aggregate principal balance of any such notes presented for conversion. As of the filing date of this report, we do not have available cash, cash equivalents and investments sufficient to repay all of the convertible notes, if presented. In addition, other than the restrictive covenants contained in our credit agreement, there are no restrictions on our use of this cash and the cash available to repay indebtedness may decline over time. If we do not have sufficient funds available to repay the principal balance of notes presented for conversion, we will be required to raise additional funds. Because the financing markets may be unwilling to provide funding to us or may only be willing to provide funding on terms that we would consider unacceptable, we may not have cash available or be able to obtain funding to permit us to meet our repayment obligations, thus adversely affecting the market price for our securities.

 

The restrictive covenants contained in our credit agreement may limit our activities.

 

With respect to our $200 million, three-year revolving credit facility, the credit agreement contains restrictive covenants which affect, and in many respects could limit or prohibit, among other things, our ability to:

 

·        incur indebtedness;

 

·        create liens;

 

·        make investments or loans;

 

·        engage in transactions with affiliates;

 

·        pay dividends or make other distributions on, or redeem or repurchase, our capital stock;

 

·        enter into various types of swap contracts or hedging agreements;

 

·        make capital contributions;

 

·        sell assets; or

 

·        pursue mergers or acquisitions.

 

Failure to comply with the restrictive covenants in our credit agreement could preclude our ability to borrow or accelerate the repayment of any debt outstanding under the credit agreement. Additionally, as a result of these restrictive covenants, we may be at a disadvantage compared to our competitors that have greater operating and financing flexibility than we do.

 

Our research and development and marketing efforts are often dependent on corporate collaborators and other third parties who may not devote sufficient time, resources and attention to our programs, which may limit our efforts to develop and market potential products.

 

To maximize our growth opportunities, we have entered into a number of collaboration agreements with third parties.  In certain countries outside the United States, we have entered into agreements with a number of partners with respect to the development, manufacturing and marketing of our products.  In some cases, our collaboration agreements call for our partners to control:

 

·        the supply of bulk or formulated drugs for use in clinical trials or for commercial use;

 

·        the design and execution of clinical studies;

 

·        the process of obtaining regulatory approval to market the product; and/or

 

·        marketing and selling of an approved product.

 

In each of these areas, our partners may not support fully our research and commercial interests because our program may compete for time, attention and resources with the internal programs of our corporate collaborators.  As such, our program may not move forward as effectively, or advance as rapidly, as it might if we had retained complete control of all research, development, regulatory and commercialization decisions.  We also rely on some of these collaborators and other third parties for the production of compounds and the manufacture and supply of pharmaceutical products.  Additionally, we may find it necessary from time to time to seek new or additional partners to assist us in commercializing our products, though we ultimately might not be successful in establishing any such new or additional relationships.

 

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The efforts of government entities and third party payers to contain or reduce the costs of health care may adversely affect our sales and limit the commercial success of our products.

 

In certain foreign markets, pricing or profitability of pharmaceutical products is subject to various forms of direct and indirect governmental control, including the control over the amount of reimbursements provided to the patient who is prescribed specific pharmaceutical products. For example, we are aware of governmental efforts in France to limit or eliminate reimbursement for some of our products, particularly FONZYLANE, FONLIPOL and OLMIFON, which could impact revenues from our French operations.

 

In the United States, there have been, and we expect there will continue to be, various proposals to implement similar controls. The commercial success of our products could be limited if federal or state governments adopt any such proposals. In addition, in the United States and elsewhere, sales of pharmaceutical products depend in part on the availability of reimbursement to the consumer from third party payers, such as government and private insurance plans. These third party payers are increasingly utilizing their significant purchasing power to challenge the prices charged for pharmaceutical products and seek to limit reimbursement levels offered to consumers for such products. Moreover, many governments and private insurance plans have instituted reimbursement schemes that favor the substitution of generic pharmaceuticals for more expensive brand-name pharmaceuticals. In the United States in particular, generic substitution statutes have been enacted in virtually all states and permit or require the dispensing pharmacist to substitute a less expensive generic drug instead of an original branded drug. These third party payers are focusing their cost control efforts on our products, especially with respect to prices of and reimbursement levels for products prescribed outside their labeled indications. In these cases, their efforts may negatively impact our product sales and profitability.

 

We experience intense competition in our fields of interest, which may adversely affect our business.

 

Large and small companies, academic institutions, governmental agencies and other public and private research organizations conduct research, seek patent protection and establish collaborative arrangements for product development in competition with us. Products developed by any of these entities may compete directly with those we develop or sell.

 

The conditions that our products treat, and some of the other disorders for which we are conducting additional studies, are currently treated with many drugs, several of which have been available for a number of years or are available in inexpensive generic forms. With respect to PROVIGIL and, when launched, NUVIGIL, there are several other products used for the treatment of excessive sleepiness or narcolepsy in the United States, including methylphenidate products, and in our other territories, many of which have been available for a number of years and are available in inexpensive generic forms. With respect to AMRIX, we face significant competition from SKELAXIN®, FLEXERIL® and other inexpensive generic forms of muscle relaxants.  With respect to FENTORA, we face competition from numerous short-and long-acting opioid products, including three products—Johnson & Johnson’s DURAGESIC® and Purdue Pharmaceutical’s OXYCONTIN® and MS-CONTIN®—that dominate the market. In addition, we are aware of numerous other companies developing other technologies for rapidly delivering opioids to treat breakthrough pain that will compete against FENTORA in the market for breakthrough cancer pain in opioid-tolerant patients.  It also is possible that the existence of generic OTFC could negatively impact the growth of FENTORA.  With respect to ACTIQ, generic competition from Barr has meaningfully eroded branded ACTIQ sales and impacted sales of our own generic OTFC through Watson.  Our generic sales also could be significantly impacted by the entrance into the market of additional generic OTFC products, which could occur at any time. With respect to TREANDA, we face competition from LEUKERAN®, CAMPATH® and the combination therapy of fludarabine, cyclophosphamide and rituximab.  With respect to VIVITROL, we face competition from CAMPRAL® and oral naltrexone. With respect to TRISENOX, the pharmaceutical market for the treatment of patients with relapsed or refractory APL is served by a number of available therapeutics, such as VESANOID® by Roche in combination with chemotherapy.

 

For all of our products, we need to demonstrate to physicians, patients and third party payers that the cost of our products is reasonable and appropriate in the light of their safety and efficacy, the price of competing products and the related health care benefits to the patient.

 

Many of our competitors have substantially greater capital resources, research and development staffs and facilities than we have, and substantially greater experience in conducting clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products. These entities represent significant competition for us. In addition, competitors who are developing products for the treatment of neurological or oncological disorders might succeed in developing technologies and products that are more effective than any that we develop or sell or that would render our technology and products obsolete or noncompetitive. Competition and innovation from these or other sources, including

 

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advances in current treatment methods, could potentially affect sales of our products negatively or make our products obsolete. Furthermore, we may be at a competitive marketing disadvantage against companies that have broader product lines and whose sales personnel are able to offer more complementary products than we can. Any failure to maintain our competitive position could adversely affect our business and results of operations.

 

We plan to consider and, as appropriate, make acquisitions of technologies, products and businesses, which may subject us to a number of risks and/or result in us experiencing significant charges to earnings that may adversely affect our stock price, operating results and financial condition.

 

As part of our efforts to acquire businesses or to enter into other significant transactions, we conduct business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, we might not realize the intended advantages of the acquisition. If we fail to realize the expected benefits from acquisitions we have consummated or may consummate in the future, whether as a result of unidentified risks, integration difficulties, regulatory setbacks or other events, our business, results of operations and financial condition could be adversely affected. In connection with an acquisition, we must estimate the value of the transaction by making certain assumptions about, among other things, likelihood of regulatory approval for unapproved products and the market potential for marketed products and/or product candidates. Ultimately, our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of a transaction.

 

In addition, we have experienced, and will likely continue to experience, significant charges to earnings related to our efforts to consummate acquisitions. For transactions that ultimately are not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants and other advisers in connection with our efforts. Even if our efforts are successful, we may incur as part of a transaction substantial charges for closure costs associated with the elimination of duplicate operations and facilities and acquired in-process research and development charges. In either case, the incurrence of these charges could adversely affect our results of operations for particular quarterly or annual periods.

 

We may be unable to successfully consolidate and integrate the operations of businesses we acquire, which may adversely affect our stock price, operating results and financial condition.

 

We must consolidate and integrate the operations of acquired businesses with our business. Integration efforts often take a significant amount of time, place a significant strain on our managerial, operational and financial resources and could prove to be more difficult and expensive than we predicted. The diversion of our management’s attention and any delays or difficulties encountered in connection with these recent acquisitions, and any future acquisitions we may consummate, could result in the disruption of our ongoing business or inconsistencies in standards, controls, procedures and policies that could negatively affect our ability to maintain relationships with customers, suppliers, employees and others with whom we have business dealings.

 

The results and timing of our research and development activities, including future clinical trials, are difficult to predict, subject to potential future setbacks and, ultimately, may not result in viable pharmaceutical products, which may adversely affect our business.

 

In order to sustain our business, we focus substantial resources on the search for new pharmaceutical products. These activities include engaging in discovery research and process development, conducting preclinical and clinical studies and seeking regulatory approval in the United States and abroad. In all of these areas, we have relatively limited resources and compete against larger, multinational pharmaceutical companies. Moreover, even if we undertake these activities in an effective and efficient manner, regulatory approval for the sale of new pharmaceutical products remains highly uncertain because the majority of compounds discovered do not enter clinical studies and the majority of therapeutic candidates fail to show the human safety and efficacy necessary for regulatory approval and successful commercialization.

 

In the pharmaceutical business, the research and development process generally takes 12 years or longer, from discovery to commercial product launch. During each stage of this process, there is a substantial risk of failure. Preclinical testing and clinical trials must demonstrate that a product candidate is safe and efficacious. The results from preclinical testing and early clinical trials may not be predictive of results obtained in subsequent clinical trials, and these clinical trials may not demonstrate the safety and efficacy necessary to obtain regulatory approval for any product candidates. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. For ethical reasons, certain clinical trials are conducted with patients

 

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having the most advanced stages of disease and who have failed treatment with alternative therapies. During the course of treatment, these patients often die or suffer other adverse medical effects for reasons that may not be related to the pharmaceutical agent being tested. Such events can have a negative impact on the statistical analysis of clinical trial results.

 

The completion of clinical trials of our product candidates may be delayed by many factors, including the rate of enrollment of patients. Neither we nor our collaborators can control the rate at which patients present themselves for enrollment, and the rate of patient enrollment may not be consistent with our expectations or sufficient to enable clinical trials of our product candidates to be completed in a timely manner or at all. In addition, we may not be permitted by regulatory authorities to undertake additional clinical trials for one or more of our product candidates. Even if such trials are conducted, our product candidates may not prove to be safe and efficacious or receive regulatory approvals. Any significant delays in, or termination of, clinical trials of our product candidates could impact our ability to generate product sales from these product candidates in the future.

 

The price of our common stock has been and may continue to be highly volatile, which may make it difficult for stockholders to sell our common stock when desired or at attractive prices.

 

The market price of our common stock is highly volatile, and we expect it to continue to be volatile for the foreseeable future. For example, from January 1, 2007 through October 31, 2008 our common stock traded at a high price of $84.83 and a low price of $56.20. Negative announcements, including, among others:

 

·        adverse regulatory decisions;

 

·        disappointing clinical trial results;

 

·        legal challenges, disputes and/or other adverse developments impacting our patents or other proprietary products; or

 

·        sales or operating results that fall below the market’s expectations

 

could trigger significant declines in the price of our common stock. In addition, external events, such as news concerning economic conditions, our competitors or our customers, changes in government regulations impacting the biotechnology or pharmaceutical industries or the movement of capital into or out of our industry, also are likely to affect the price of our common stock, regardless of our operating performance.

 

Our internal controls over financial reporting may not be considered effective, which could result in possible regulatory sanctions and a decline in our stock price.

 

Section 404 of the Sarbanes-Oxley Act of 2002 requires us to furnish annually a report on our internal controls over financial reporting and to maintain effective disclosure controls and procedures and internal controls over financial reporting. In order for management to evaluate our internal controls, we must regularly review and document our internal control processes and procedures and test such controls. Ultimately, we or our independent auditors could conclude that our internal controls over financial reporting may not be effective if, among other things:

 

·        any material weakness in our internal controls over financial reporting exists; or

 

·        we fail to remediate assessed deficiencies.

 

During 2008, we have expanded our SAP® implementation for U.S. operations to include modules in the areas of procurement, supply chain and logistics and sales.  This expansion required changes to certain aspects of our existing system of internal controls over financial reporting.  Due to the number of controls to be examined, both with respect to this phase of the implementation and our other internal controls over financial reporting, the complexity of our processes, and the subjectivity involved in determining the effectiveness of controls, we cannot be certain that, in the future, all of our controls will continue to be considered effective by management or, if considered effective by our management, that our auditors will agree with such assessment.

 

If, in the future, we are unable to assert that our internal controls over financial reporting are effective, or if our auditors are unable to express an opinion on the effectiveness of our internal controls over financial reporting, we could be subject to regulatory sanctions or lose investor confidence in the accuracy and completeness of our financial reports, either of which could have an adverse effect on the market price for our securities.

 

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A portion of our revenues and expenses is subject to exchange rate fluctuations in the normal course of business, which could adversely affect our reported results of operations.

 

Historically, a portion of our revenues and expenses has been earned and incurred, respectively, in currencies other than the U.S. dollar. For the nine months ended September 30, 2008, 20% of our revenues were denominated in currencies other than the U.S. dollar. We translate revenues earned and expenses incurred into U.S. dollars at the average exchange rate applicable during the relevant period. A weakening of the U.S. dollar would, therefore, increase both our revenues and expenses. Fluctuations in the rate of exchange between the U.S. dollar and the euro and other currencies may affect period-to-period comparisons of our operating results. Historically, we have not hedged our exposure to these fluctuations in exchange rates.

 

Our customer base is highly concentrated.

 

Our principal customers are wholesale drug distributors. These customers comprise a significant part of the distribution network for pharmaceutical products in the United States. Three large wholesale distributors, Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation, control a significant share of this network. These three wholesaler customers, in the aggregate, accounted for 63% of our total consolidated gross sales for the nine months ended September 30, 2008. Fluctuations in the buying patterns of these customers, which may result from seasonality, wholesaler buying decisions or other factors outside of our control, could significantly affect the level of our net sales on a period to period basis. Because of this, the amounts purchased by these customers during any quarterly or annual period may not correlate to the level of underlying demand evidenced by the number of prescriptions written for such products, as reported by IMS Health Incorporated.

 

We are involved, or may become involved in the future, in legal proceedings that, if adversely adjudicated or settled, could materially impact our financial condition.

 

As a biopharmaceutical company, we are or may become a party to litigation in the ordinary course of our business, including, among others, matters alleging employment discrimination, product liability, patent or other intellectual property rights infringement, patent invalidity or breach of commercial contract. In general, litigation claims can be expensive and time consuming to bring or defend against and could result in settlements or damages that could significantly impact results of operations and financial condition. We currently are vigorously defending ourselves against those matters specifically described in Note 11 of the Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q as well as numerous other litigation matters. While we currently do not believe that the settlement or adverse adjudication of these other litigation matters would materially impact our results of operations or financial condition, the final resolution of these matters and the impact, if any, on our results of operations, financial condition or cash flows is unknown but could be material.

 

Our dependence on key executives and scientists could impact the development and management of our business.

 

We are highly dependent upon our ability to attract and retain qualified scientific, technical and managerial personnel. There is intense competition for qualified personnel in the pharmaceutical and biotechnology industries, and we cannot be sure that we will be able to continue to attract and retain the qualified personnel necessary for the development and management of our business. Although we do not believe the loss of one individual would materially harm our business, our business might be harmed by the loss of the services of multiple existing personnel, as well as the failure to recruit additional key scientific, technical and managerial personnel in a timely manner. Much of the know-how we have developed resides in our scientific and technical personnel and is not readily transferable to other personnel. While we have employment agreements with our key executives, we do not ordinarily enter into employment agreements with our other key scientific, technical and managerial employees. We do not maintain “key man” life insurance on any of our employees.

 

We may be required to incur significant costs to comply with environmental laws and regulations, and our related compliance may limit any future profitability.

 

Our research and development activities involve the controlled use of hazardous, infectious and radioactive materials that could be hazardous to human health and safety or the environment. We store these materials, and various wastes resulting from their use, at our facilities pending ultimate use and disposal. We are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials

 

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and wastes, and we may be required to incur significant costs to comply with related existing and future environmental laws and regulations.

 

While we believe that our safety procedures for handling and disposing of these materials comply with foreign, federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of an accident, we could be held liable for any resulting damages, which could include fines and remedial costs. These damages could require payment by us of significant amounts over a number of years, which could adversely affect our results of operations and financial condition.

 

Anti-takeover provisions may delay or prevent changes in control of our management or deter a third party from acquiring us, limiting our stockholders’ ability to profit from such a transaction.

 

Our Board of Directors has the authority to issue up to 5,000,000 shares of preferred stock, $0.01 par value, of which 1,000,000 have been reserved for issuance in connection with our stockholder rights plan, and to determine the price, rights, preferences and privileges of those shares without any further vote or action by our stockholders. Our stockholder rights plan could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock.

 

We are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which prohibits us from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person becomes an interested stockholder, unless the business combination is approved in a prescribed manner. The application of Section 203 could have the effect of delaying or preventing a change of control of Cephalon. Section 203, the rights plan, and certain provisions of our certificate of incorporation, our bylaws and Delaware corporate law, may have the effect of deterring hostile takeovers, or delaying or preventing changes in control of our management, including transactions in which stockholders might otherwise receive a premium for their shares over then-current market prices.

 

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ITEM 5.  OTHER INFORMATION

 

Computation of Ratios of Earnings to Fixed Charges

 

 

 

 

 

Nine months
ended

 

 

 

Year Ended

 

September

 

 

 

December 31,

 

30,

 

 

 

2003

 

2004

 

2005

 

2006

 

2007

 

2008

 

Determination of earnings:

 

 

 

 

 

 

 

 

 

 

 

 

 

Pre-tax income (loss) from continuing operations

 

$

130,314

 

$

(28,184

)

$

(245,118

)

$

238,254

 

$

(68,419

)

$

206,587

 

Add:

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of interest capitalized in current or prior periods

 

 

 

 

52

 

98

 

184

 

Fixed charges

 

31,191

 

25,623

 

30,985

 

28,171

 

28,960

 

33,046

 

Total earnings

 

$

161,505

 

$

(2,561

)

$

(214,133

)

$

266,477

 

$

(39,361

)

$

239,817

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fixed charges:

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense and amortization of debt discount and premium on all indebtedness

 

28,905

 

22,186

 

25,235

 

18,922

 

19,833

 

25,697

 

Appropriate portion of rentals

 

2,286

 

3,437

 

5,750

 

9,249

 

9,127

 

7,349

 

Fixed charges

 

31,191

 

25,623

 

30,985

 

28,171

 

28,960

 

33,046

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Capitalized interest

 

 

 

1,044

 

1,766

 

768

 

77

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total fixed charges

 

$

31,191

 

$

25,623

 

$

32,029

 

$

29,937

 

$

29,728

 

$

33,123

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ratio of earnings to fixed charges(1)

 

5.18

 

 

 

8.90

 

 

7.24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Deficiency of earnings to fixed charges

 

 

28,184

 

246,162

 

 

69,089

 

 

 


(1)

 

For the years ended December 31, 2004, 2005 and 2007, no ratios are provided because earnings were insufficient to cover fixed charges.

 

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ITEM 6.  EXHIBITS

 

Exhibit No.

 

Description

10.1

 

Credit Agreement dated as of August 15, 2008 among Cephalon, Inc., the lenders named therein, JPMorgan Chase Bank, N.A., as administrative agent, Deutsche Bank Securities Inc. and Bank of America N.A., as co-syndication agents, Wachovia Bank, N.A. and Barclays Bank plc, as co-documentation agents, and J.P. Morgan Securities Inc., Deutsche Bank Securities Inc. and Banc of America Securities LLC, as joint bookrunners and joint lead arrangers, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on August 18, 2008.

10.2

 

Letter to Takeda Pharmaceuticals North America, Inc. dated August 29, 2008, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 3, 2008.

10.3

 

Settlement Agreement dated as of September 29, 2008 among Cephalon, Inc., the U.S. Department of Justice, the U.S. Attorney’s Office for the Eastern District of Pennsylvania, the Office of Inspector General of the Department of Health and Human Services, TRICARE Management Activity, the U.S. Office of Personnel Management and the relators identified therein, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 29, 2008.

10.4

 

Corporate Integrity Agreement dated as of September 29, 2008 between the Office of Inspector General of the Department of Health and Human Services and Cephalon, Inc., filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on September 29, 2008.

10.5

 

Form of State Settlement Agreement and Release dated as of September 29, 2008 between Cephalon, Inc. and each of the 50 States and the District of Columbia, filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on September 29, 2008.

31.1*

 

Certification of Frank Baldino, Jr., Ph.D., Chairman and Chief Executive Officer of the Company, as required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*

 

Certification of J. Kevin Buchi, Executive Vice President and Chief Financial Officer of the Company, as required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1#

 

Certification of Frank Baldino, Jr., Ph.D., Chairman and Chief Executive Officer of the Company, as required pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2#

 

Certification of J. Kevin Buchi, Executive Vice President and Chief Financial Officer of the Company, as required pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 


*

 

Filed herewith.

 

 

 

#

 

This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section. Further, this exhibit shall not be deemed to be incorporated by reference in any document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

 

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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.

 

 

CEPHALON, INC.

 

(Registrant)

 

 

 

 

 

 

November 5, 2008

By

/s/ FRANK BALDINO, JR.

 

 

Frank Baldino, Jr., Ph.D.

 

 

Chairman and Chief Executive Officer

 

 

(Principal executive officer)

 

 

 

 

 

 

 

By

/s/ J. KEVIN BUCHI

 

 

J. Kevin Buchi

 

 

Executive Vice President and Chief Financial Officer

 

 

(Principal financial and accounting officer)

 

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