-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J5iET09nGdkK2WESDUKCrmEyZS4jlIs0rWPcd3aeTCfmDow2e76/sOS49ktyexVm BmjhwW9THS0nvTJc2w6wQA== 0001104659-09-033916.txt : 20090522 0001104659-09-033916.hdr.sgml : 20090522 20090520160412 ACCESSION NUMBER: 0001104659-09-033916 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20090520 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090520 DATE AS OF CHANGE: 20090520 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 09842619 BUSINESS ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 8-K 1 a09-13592_28k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

 


 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported) May 20, 2009

 

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-19119

 

23-2484489

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

41 Moores Road

 

 

Frazer, Pennsylvania

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code (610) 344-0200

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 8.01 Other Events.

 

This Form 8-K is being filed by Cephalon, Inc. (the “Company”) to retrospectively adjust portions of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed on February 23, 2009 (the “2008 Form 10-K”), to reflect our adoption, effective January 1, 2009, of FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement),” and FASB Statement No. 160, “Noncontrolling Interests in Consolidated Financial Statements — an Amendment of ARB No. 51.”

 

APB 14-1 specifies that issuers of convertible debt instruments that may be settled in cash upon conversion should separately account for the liability and equity components in a manner that will reflect the entity’s nonconvertible debt borrowing rate.  In June 2003, we issued and sold $750.0 million of zero coupon convertible notes in two tranches: $375.0 million first putable June 2008 and $375.0 million first putable June 2010.  In June and July 2005, we issued $920.0 million of 2.0% notes.  In December 2006, we exchanged $436.9 million of our zero coupon convertible notes for cash payments and common stock.  In June 2008, we redeemed the remaining $213.0 million of zero coupon convertible notes first putable June 2008.  At December 31, 2008, we have $199.9 million of our zero coupon convertible notes first putable June 2010 and $820.0 million of our 2.0% notes outstanding.  The adoption of APB 14-1 resulted in a decrease in net income of $29.6 million, $32.3 million, and $30.9 million for the years ended December 31, 2008, 2007 and 2006, respectively.  Prior period information presented in the Exhibits to this Form 8-K has been restated, where required.

 

SFAS No. 160 establishes accounting and reporting standards for noncontrolling interests (i.e., minority interests) in a subsidiary, including changes in a parent’s ownership interest in a subsidiary, and requires, among other things, that noncontrolling interests in subsidiaries be classified as shareholders’ equity. Prior period information presented in the Exhibits to this Form 8-K has been reclassified, where required.

 

The following Items of the 2008 Form 10-K are being adjusted retrospectively to reflect the adoption of the accounting pronouncements described above (which Items as adjusted are attached as Exhibits hereto and hereby incorporated by reference herein):

 

Item 6 — Selected Financial Data

Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 8 — Financial Statements and Supplementary Data

Item 15—Exhibit 12.1 — Computation of Ratios of Earnings to Fixed Charges

 

No Items of the 2008 Form 10-K other than those identified above are being revised by this filing. Information in the 2008 Form 10-K is generally stated as of December 31, 2008 and this filing does not reflect any subsequent information or events other than the adoption of the accounting pronouncements described above. Without limitation of the foregoing, this filing does not purport to update the Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in the 2008 Form 10-K for any information, uncertainties, transactions, risks, events or trends occurring, or known to management. More current information is contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2009 and other filings with the Securities and Exchange Commission. This Current Report on Form 8-K should be read in conjunction with the 2008 Form 10-K and such Quarterly Report on Form 10-Q and other filings. The Form 10-Q and other filings contain important information regarding events, developments and updates to certain expectations of the Company that have occurred since the filing of the 2008 Form 10-K.

 

2



 

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibits

 

 

23.1

Consent of PricewaterhouseCoopers LLP

 

 

99.1

Item 6, Form 10-K — Selected Financial Data

 

 

99.2

Item 7, Form 10-K — Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

99.3

Item 8, Form 10-K — Financial Statements and Supplementary Data

 

 

99.4

Item 15, Form 10-K — Exhibit 12.1 — Computation of Ratio of Earnings to Fixed Charges

 

3



 

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 hereunto duly authorized.

 

 

CEPHALON, INC.

 

 

 

 

 

 

Date: May 20, 2009

By:

/s/ J. Kevin Buchi

 

 

J. Kevin Buchi

 

 

Executive Vice President & Chief Financial Officer

 

4


EX-23.1 2 a09-13592_2ex23d1.htm EX-23.1

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We hereby consent to the incorporation by reference in the Registration Statements on Forms S-3 (Nos. 333-108320, 333-112541, 333-122418 and 333-134464) and Forms S-8 (Nos. 33-43716, 33-71920, 333-02888, 333-69591, 333-89909, 333-87421, 333-52640, 333-43104, 333-89228, 333-89230, 333-106112, 333-106115, 333-118611, 333-134462, 333-134463, 333-147374 and 333-155210) of Cephalon, Inc. of our report dated February 23, 2009, except with respect to our opinion on the consolidated financial statements insofar as it relates to the effects of the change in accounting for non-controlling interests (Note 1) and convertible debt instruments (Note 1), as to which the date is May 20, 2009, relating to the financial statements, financial statement schedule and the effectiveness of internal control over financial reporting, which appears in this Current Report on Form 8-K.

 

/s/ PricewaterhouseCoopers LLP

Philadelphia, Pennsylvania

May 20, 2009

 


EX-99.1 3 a09-13592_2ex99d1.htm EX-99.1

Exhibit 99.1

 

ITEM 6. SELECTED FINANCIAL DATA

(In thousands, except per share data)

 

On November 3, 2008, we entered into a series of agreements with Acusphere, Inc. that resulted in Acusphere issuing to us a $15 million senior secured convertible note, convertible into, among other potential options, a controlling interest in Acusphere; we also acquired license rights to certain Acusphere intellectual property in exchange for $5 million plus future royalty payments.  On March 28, 2008 we acquired certain intellectual property from Acusphere in exchange for $10 million.  We have determined that, as a result of these transactions, Acusphere is a variable interest entity and we are the primary beneficiary.   As a result, we have consolidated Acusphere’s results in accordance with FIN 46R, “Consolidation of Variable Interest Entities” (“FIN 46R”), as of November 3, 2008.

 

We completed the acquisitions of AMRIX® in August 2007, the issued share capital of Zeneus Holdings Limited on December 22, 2005, substantially all assets related to the TRISENOX® (arsenic trioxide) injection business from CTI and CTI Technologies, Inc., a wholly-owned subsidiary of CTI on July 18, 2005, outstanding capital stock of Salmedix, Inc. on June 14, 2005 and the outstanding shares of capital stock of CIMA LABS on August 12, 2004. These acquisitions have been accounted for either as business combinations or asset purchases.

 

Five-year summary of selected financial data:

 

 

 

Year Ended December 31,

 

Statement of operations data

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (3)

 

As Adjusted
2006(1), (3)

 

As Adjusted
2005(1), (3)

 

As Adjusted
2004(1), (3)

 

Sales

 

$

1,943,464

 

$

1,727,299

 

$

1,720,172

 

$

1,156,518

 

$

980,375

 

Other revenues

 

31,090

 

45,339

 

43,897

 

55,374

 

35,050

 

Total revenues

 

1,974,554

 

1,772,638

 

1,764,069

 

1,211,892

 

1,015,425

 

 

 

 

 

 

 

 

 

 

 

 

 

Settlement reserve

 

7,450

 

425,000

 

 

 

 

Impairment charges

 

99,719

 

 

12,417

 

20,820

 

30,071

 

Acquired in-process research and development

 

41,955

 

 

5,000

 

366,815

 

185,700

 

Debt exchange expense

 

 

 

41,106

 

 

28,230

 

Write-off of deferred debt issuance costs

 

 

 

 

 

 

Restructuring charge

 

8,415

 

 

 

 

 

Loss on sale of equipment

 

17,178

 

1,022

 

 

 

 

Income tax expense (benefit)

 

(37,819

)

103,153

 

76,524

 

(77,279

)

43,548

 

Net income (loss)

 

171,889

 

(226,429

)

115,642

 

(187,227

)

(77,356

)

Net loss attributable to noncontrolling interest

 

21,073

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) attributable to Cephalon, Inc.

 

$

192,962

 

$

(226,429

)

$

115,642

 

$

(187,227

)

$

(77,356

)

 

 

 

 

 

 

 

 

 

 

 

 

Basic income (loss) per common share attributable to Cephalon, Inc.

 

$

2.84

 

$

(3.40

)

$

1.91

 

$

(3.23

)

$

(1.37

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding

 

68,018

 

66,597

 

60,507

 

58,051

 

56,489

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share attributable to Cephalon, Inc.

 

$

2.54

 

$

(3.40

)

$

1.66

 

$

(3.23

)

$

(1.37

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding-assuming dilution

 

76,097

 

66,597

 

69,672

 

58,051

 

56,489

 

 

 

 

December 31,

 

Balance sheet data

 

As Adjusted
2008(1), (2)

 

As Adjusted 2007(1), (3)

 

As Adjusted 2006(1), (3)

 

As Adjusted 2005(1), (3)

 

As Adjusted 2004(1), (3)

 

Cash, cash equivalents and investments

 

$

524,459

 

$

826,265

 

$

521,724

 

$

484,090

 

$

791,676

 

Total assets

 

3,082,942

 

3,395,759

 

2,937,339

 

2,638,907

 

2,315,615

 

Current portion of long-term debt

 

781,618

 

944,659

 

701,074

 

590,038

 

5,114

 

Long-term debt (excluding current portion)

 

3,692

 

3,788

 

206,895

 

617,944

 

1,102,734

 

Redeemable Equity

 

248,402

 

292,509

 

322,239

 

343,122

 

0

 

Accumulated deficit

 

(521,286

)

(714,248

)

(480,651

)

(596,293

)

(409,066

)

Equity

 

1,416,680

 

1,191,557

 

1,203,947

 

577,025

 

930,413

 

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

 

(2) As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”  See Note 1 of the Consolidated Financial Statements for additional information.

 

(3) As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 of the Consolidated Financial Statements for additional information.

 


EX-99.2 4 a09-13592_2ex99d2.htm EX-99.2

Exhibit 99.2

 

ITEM 7.  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 II, Item 8 of this Annual Report on Form 10-K and the “Risk Factors” contained in Part I, Item 1A of this Annual Report on Form 10-K.

 

EXECUTIVE SUMMARY

 

Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in three core therapeutic areas: central nervous system (“CNS”), pain and oncology.  In addition to conducting an active research and development program, we market seven proprietary products in the United States and numerous products in various countries throughout Europe and the world.  Consistent with our core therapeutic areas, we have aligned our approximately 780-person U.S. field sales and sales management teams by area.  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, and certain countries in Africa and the Middle East.  For the year ended December 31, 2008, our total revenues and net income attributable to Cephalon, Inc. were $2.0 billion and $171.9 million, respectively.  Our revenues from U.S. and European operations are detailed in Note 18 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

 

Our most significant product is PROVIGIL® (modafinil) Tablets [C-IV], which comprised 51% of our total consolidated net sales for the year ended December 31, 2008, of which 94% was in the U.S. market.  For the year ended December 31, 2008, consolidated net sales of PROVIGIL increased 16% over the year ended December 31, 2007.  PROVIGIL is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (“OSA/HS”) and shift work sleep disorder (“SWSD”).  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.  Under the co-promotion agreement, TPNA provided 500 Takeda sales representatives to promote PROVIGIL to primary care physicians and other appropriate health care professionals in the United States.  As a result of the termination of the co-promotion agreement, we have supplemented our existing sales teams with an additional 270 sales representatives who began promoting PROVIGIL and AMRIX in the first quarter of 2009.  We accomplished this through a combination of new hires and use of a contract sales force.  In total, we currently have 730 sales representatives promoting PROVIGIL.  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 third quarter of 2009.  We expect that upon the launch of NUVIGIL, our marketing efforts with respect to PROVIGIL will decline substantially and will shift to NUVIGIL.  Currently, we do not believe 2009 CNS net sales will be adversely impacted as compared to 2008 by the decline in PROVIGIL marketing efforts associated with the launch of NUVIGIL.

 

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 22% of our total consolidated net sales for the year ended December 31, 2008, of which 87% 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 launched the product in certain European countries in January 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.  In May 2008, an FDA Advisory Committee voted not to recommend approval of the FENTORA sNDA.  In September 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 December 2008, we also received a supplement request letter from the FDA requesting that we submit a Risk Evaluation and Mitigation Strategy (the “REMS Program”) with respect to FENTORA, which we expect to file by the end of the first quarter of 2009.  In the December 2008 supplement request letter, the FDA also provided guidance for the design and implementation of the REMS Program to

 



 

mitigate serious risks associated with the use of FENTORA.  To address the FDA’s requests in its September 2008 and December 2008 letters, we plan to implement as part of the REMS Program a first-of-its-kind initiative designed to minimize the potential risk of overdose from an opioid through appropriate patient selection.  We believe that, by working with the FDA, we can design and implement a REMS Program to meet the FDA’s requests and possibly to provide a potential avenue for approval of the sNDA.  We anticipate initiating the REMS Program upon receipt of approval from the FDA.  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 2009.

 

In March 2008, we received FDA approval of TREANDA® (bendamustine hydrochloride) 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 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 TREANDA.

 

In August 2008, we established a $200 million, three-year revolving credit facility (the “Credit Agreement”) 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 customary 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 filing date of this Annual Report on Form 10-K, we have not drawn any amounts under the credit facility.

 

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 PROVIGIL patent settlement agreements with each of Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Ranbaxy Laboratories Limited and Barr; in August 2006, we entered into a settlement agreement with Carlsbad Technology, Inc. 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 minimum amounts of modafinil through 2012, with remaining aggregate purchase commitments totaling $57.8 million as of December 31, 2008.  Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  See Note 7 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for additional information.

 

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.

 

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.

 

In October 2008, Cephalon and Eurand, Inc. (“Eurand”) received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan Pharmaceuticals, Inc. and Barr Laboratories, Inc., each requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX.  In November 2008, we received a similar certification letter from Impax Laboratories, Inc.  Mylan and Impax each allege that the U.S. Patent Number 7,387,793 (the “Eurand Patent”), entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants,” issued to Eurand will not be infringed by the manufacture, use or sale of the product described in the applicable ANDA and reserves the right to challenge the validity and/or enforceability of the Eurand Patent.  Barr alleges that the Eurand Patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.  The Eurand Patent does not expire until February 26, 2025.  In late November 2008, Cephalon and Eurand filed a lawsuit in U.S. District Court in Delaware against Mylan (and its parent) and Barr (and its parent) for infringement of the Eurand Patent.  In January 2009, Cephalon and Eurand filed a lawsuit in U.S. District Court in Delaware against Impax for infringement of the Eurand Patent.  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.  While we intend to vigorously defend the AMRIX and FENTORA intellectual property rights, 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 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. In September 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® (tingabine hydrochloride) 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 of $0.6 million.  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.  All of the payments described above were made in the fourth quarter of 2008.

 

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.

 

In September 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.

 

We have significant levels of indebtedness outstanding, nearly all of which consists of convertible notes. Under the terms of the indentures governing nearly all of our notes, we are obligated to repay in cash the aggregate principal balance of any such notes presented for conversion. For a more complete description of these notes, see Note 12 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.  We do not have available cash, cash equivalents and investments sufficient to repay all of the 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.

 

As of December 31, 2008, the fair value of both the 2.0% convertible senior subordinated notes due June 1, 2015 (the “2.0% Notes”) and Zero Coupon Convertible Notes due June 2033, first putable June 15, 2010 (the “Zero Coupon Notes”) is greater than the value of the shares into which such notes are convertible. 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 the convertible notes would be less than the value of the common stock shares underlying the notes.  As such, we believe it is highly unlikely that holders of the 2.0% Notes or Zero Coupon Notes will present significant amounts of such notes for conversion under the current terms. In the unlikely 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. 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.

 

RECENT ACQUISITIONS

 

For additional information related to each of the following acquisitions and transactions, see Note 2 to the Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

 

LUPUZOR License

 

On November 25, 2008, we entered into an option agreement (the “Immupharma Option Agreement”) with ImmuPharma PLC providing us with an option to obtain an exclusive, worldwide license to the investigational medication LUPUZOR™ for the treatment of systemic lupus erythematosus.  On January 30, 2009, we exercised the option and entered into a Development and Commercialization Agreement (the “Immupharma License Agreement”) with Immupharma based on a review of interim results of a Phase IIb study for LUPUZOR.  Under the terms of the Immupharma Option Agreement, we paid ImmuPharma a $15 million upfront option payment upon execution and will pay a one-time $30 million license fee by early March 2009.  Under the Immupharma License Agreement, Immupharma may receive (i) up to approximately $500 million in milestone payments (including the option and license fees) upon the achievement of regulatory and sales milestones and (ii) royalties on the net sales of LUPUZOR.  We will assume all expenses for the remaining term of the Phase IIb study, the Phase III study, regulatory filings and, assuming regulatory approval, subsequent commercialization of the product.

 

Acusphere, Inc.

 

On November 3, 2008, we entered into a license and convertible note transaction with Acusphere, Inc., a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology.  In connection with the transaction, we received an exclusive worldwide license from Acusphere 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 $15 million 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 “Acusphere Note”) from Acusphere, secured by substantially all the assets of Acusphere (including Acusphere’s intellectual property).  The Acusphere 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 Acusphere 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. Separately, on March 28, 2008, we purchased license rights for Acusphere’s HDDS technology for use in oncology therapeutics for $10 million.

 



 

In accordance with FIN 46R, we have determined that effective on November 3, 2008 Acusphere is a variable interest entity for which we are the primary beneficiary.  As a result, as of November 3, 2008 we have included the financial condition and results of operations of Acusphere in our consolidated financial statements.  However, we do not have an equity interest in Acusphere and, therefore, we have allocated the losses attributable to the noncontrolling interest in Acusphere to noncontrolling interest in the consolidated statement of operations and we have also reduced the noncontrolling interest holders’ ownership interest in Acusphere in the consolidated balance sheet by Acusphere’s losses.  For the year ended December 31, 2008, both of these amounts have been limited to the value of the noncontrolling interest recorded as of November 3, 2008 but will not be limited starting January, 1 2009.

 

During 2008, as a result of the FDA Advisory Panel’s recommendation not to approve Imagify, we determined that the carrying value of Acusphere’s long-lived assets exceeded the expected cash flows from the use of its assets.  Accordingly, we reduced the property and equipment carrying values to their estimated fair value based on prices for similar assets and recognized a $9.3 million impairment charge. For the year ended December 31, 2008, a total of $21.1 million of net losses were allocated to the noncontrolling interest and $11.7 million of net losses exceeded the noncontrolling interest value.

 

Ception Therapeutics, Inc.

 

On January 13, 2009, we entered into an option agreement (the “Ception Option Agreement”) with Ception Therapeutics, Inc.  Under the terms of the Ception Option Agreement, we have the irrevocable option (the “Ception Option”) to purchase all of the outstanding capital stock on a fully diluted basis of Ception at any time on or prior to the expiration of the Option Period (as defined below).  As consideration for the Ception Option, we paid $50 million to Ception and also paid certain Ception stockholders an aggregate of $50 million.  We, in our sole discretion, may exercise the Ception Option by providing written notice to Ception at any time during the period from January 13, 2009 to and including the date that (i) is fifteen business days after our receipt of the final study report for Ception’s ongoing Phase IIb/III clinical trial for reslizumab in pediatric patients with eosinophilic esophagitis (“Res-5-0002 EE Study”) indicating that the co-primary endpoints have been achieved or (ii) is thirty business days after our receipt of the final study report for Res-5-0002 EE Study indicating that the co-primary endpoints have not been achieved (the “Option Period”).  We anticipate that the Res-5-0002 EE Study will be completed in the fourth quarter of 2009.  If the data are positive and we exercise the Ception Option, we intend to file a Biologics License Application for reslizumab with the FDA in 2010.  If we exercise the Ception Option, we have agreed to pay a total of $250 million in exchange for all the outstanding capital stock of Ception on a fully-diluted basis.  Ception stockholders also could receive (i) additional payments related to clinical and regulatory milestones and (ii) royalties related to net sales of products developed from Ception’s program to discover small molecule, orally-active, anti-TNF (tumor necrosis factor) receptor agents.

 

 In November 2008, we paid a $25 million non-refundable fee to Ception for exclusive rights to negotiate the Option. This payment was credited against the Ception Option Agreement payments.  In accordance with FIN 46R, we have determined that effective on January 13, 2009 Ception is a variable interest entity for which we are the primary beneficiary.  As a result, as of January 13, 2009 we will include the financial condition and results of operations of Ception in our consolidated financial statements.

 

AMRIX Acquisition

 

In August 2007, we acquired exclusive North American rights to AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) from E. Claiborne Robins Company, Inc., a privately-held company d/b/a ECR Pharmaceuticals (“ECR”). We made an initial payment of $100.1 million cash to ECR upon the closing of the acquisition, $0.9 million and $99.2 million of which was capitalized as inventory and an intangible asset, respectively.  Under the acquisition agreement, ECR also could receive up to an additional $255 million in milestone payments that are contingent on attainment of certain agreed-upon sales levels of AMRIX.  Two dosage strengths of AMRIX (15 mg and 30 mg) were approved in February 2007 by the FDA for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm 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 promoting AMRIX.  Through an expansion of our contract sales force and through new hires, we have added an additional 270 sales representatives who began promoting PROVIGIL and AMRIX in the first quarter of 2009.  In total, we currently have 840 sales representatives promoting AMRIX.  In June 2008, the U.S. Patent and Trademark Office issued a pharmaceutical formulation patent for AMRIX, which expires in February 2025.

 



 

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 was 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 2008, we incurred $8.4 million related to the restructuring.  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 $20 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 third quarter 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 remaining aggregate purchase commitments totaling $57.8 million as of December 31, 2008.  Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  See Note 7 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for additional information.

 

Effective October 1, 2008, we changed our method of accounting for inventories previously valued using the last-in, first-out (LIFO) method to the first-in, first-out (FIFO) method and adjusted our results for all of the periods presented.

 

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 year we have recorded pre-tax, non-cash charges associated with accelerated depreciation of plant and equipment of $6.0 million related to the proposed divestiture based on the new estimated useful life.  As of December 31, 2008, we had $34.8 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 are 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 were calculated based on a percentage of royalties to TPNA during the final twelve months of the agreement.  In 2008, we recorded an accrual of $28.2 million,

 



 

representing the present value of the Sunset Payments due to TPNA.  Payment of this accrual will occur over the next three years.

 

TERMINATION OF COLLABORATION

 

On November 26, 2008, we entered into a termination agreement (the “Termination Agreement”) with Alkermes, Inc. to end our collaboration.  As of December 1, 2008, we are no longer responsible for the marketing and sale of VIVITROL in the United States.  The Termination Agreement is intended to reduce our cost structure and enhance competitiveness.  Pursuant to the Termination Agreement, we will incur certain costs associated with exit or disposal activities.  The pretax charges associated with the Termination Agreement total $119.8 million.  These charges include (i) cash charges of $12.2 million, consisting of a termination payment of $11.0 million to Alkermes and severance costs of $1.2 million and (ii) non-cash charges of $107.6 million, consisting of the $17.2 million loss on sale of the Product Manufacturing Equipment and other Capital Improvements (as such terms are defined in the Supply Agreement effective as of June 23, 2005 between the parties, as amended to date) and the $90.4 million impairment charge to write-off the net book value of the VIVITROL intangible assets.  These pretax charges have been recognized in the fourth quarter of 2008.

 

RESULTS OF OPERATIONS

(In thousands)

 

Year ended December 31, 2008 compared to year ended December 31, 2007:

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

 

 

2008

 

2007

 

% Increase (Decrease)

 

 

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

924,986

 

$

63,432

 

$

988,418

 

$

801,639

 

$

50,408

 

$

852,047

 

15

%

26

%

16

%

GABITRIL

 

52,441

 

8,256

 

60,697

 

50,642

 

6,668

 

57,310

 

4

 

24

 

6

 

CNS

 

977,427

 

71,688

 

1,049,115

 

852,281

 

57,076

 

909,357

 

15

 

26

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

122,980

 

53,541

 

176,521

 

199,407

 

40,665

 

240,072

 

(38

)

32

 

(26

)

Generic OTFC

 

95,760

 

 

95,760

 

129,033

 

 

129,033

 

(26

)

 

(26

)

FENTORA

 

155,246

 

 

155,246

 

135,136

 

 

135,136

 

15

 

 

15

 

AMRIX

 

73,641

 

 

73,641

 

8,401

 

 

8,401

 

777

 

 

777

 

Pain

 

447,627

 

53,541

 

501,168

 

471,977

 

40,665

 

512,642

 

(5

)

32

 

(2

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

75,132

 

 

75,132

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

18,566

 

91,919

 

110,485

 

16,561

 

76,316

 

92,877

 

12

 

20

 

19

 

Oncology

 

93,698

 

91,919

 

185,617

 

16,561

 

76,316

 

92,877

 

466

 

20

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

49,667

 

157,897

 

207,564

 

52,702

 

159,721

 

212,423

 

(6

)

(1

)

(2

)

Total Sales

 

1,568,419

 

375,045

 

1,943,464

 

1,393,521

 

333,778

 

1,727,299

 

13

 

12

 

13

 

Other Revenues

 

29,546

 

1,544

 

31,090

 

40,149

 

5,190

 

45,339

 

(26

)

(70

)

(31

)

Total Revenues

 

$

1,597,965

 

$

376,589

 

$

1,974,554

 

$

1,433,670

 

$

338,968

 

$

1,772,638

 

11

%

11

%

11

%

 

Sales—In the United States, we sell our proprietary products to pharmaceutical wholesalers, the largest three of which accounted for 71% and 66% of our total consolidated gross sales for the years ended December 31, 2008 and 2007, respectively. 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 December 31, 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. At December 31, 2008, we believe that inventory held at wholesalers and retailers of our generic OTFC product, launched in October 2006, is approximately five months supply at our current sales levels.

 

For the year ended December 31, 2008, sales were impacted by 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 year ended December 31, 2008, total sales increased over the prior year. The other key factors that contributed to the changes in sales are summarized by product as follows:

 

·                  In CNS, sales of PROVIGIL increased 16 percent. Sales of PROVIGIL in the U.S. increased 15% as a result of average domestic price increases of 16% from period to period.  U.S. prescriptions for PROVIGIL decreased by 2%, according to IMS Health.  European sales increased due to the favorable effect of exchange rate changes and stronger sales in substantially all territories.  In 2009, we expect CNS sales to increase as compared to 2008 as a result of increased sales for PROVIGIL, based on the full year impact of the 2008 price increases, and the launch of NUVIGIL in the third quarter of 2009.

 

·                  In Pain, sales decreased 2 percent. Sales of ACTIQ in the U.S. were impacted by increases in domestic prices of 21% from period to period, offset by a 51% decrease in U.S. prescriptions, according to IMS Health, resulting from the continued erosion of sales due to generic competition to ACTIQ.  Net sales of ACTIQ also decreased due to an increase in returns during the second half of 2008. Sales of generic OTFC decreased 26% due to decreases in prices and to a 12% decrease in prescriptions according to IMS Health.  Sales of FENTORA increased 15% due primarily to increases in domestic prices of 14%, offset by an increase in returns during the fourth quarter of 2008.  We recognized $73.6 million of revenue related to sales of AMRIX during the product’s first full year in the marketplace; in 2007, we recognized $8.4 million of revenue related to sales of AMRIX.  European sales of ACTIQ increased 32% due to increases in unit sales and the favorable effect of exchange rate changes.  In 2009, we expect overall sales of our Pain products to increase as compared to 2008 based on the growth in sales of AMRIX.

 

·                  In Oncology, sales increased 100 percent. U.S. sales increased due to the $75.1 million of U.S. sales of TREANDA, which was launched in April 2008. Sales of our European oncology products increased 20% due primarily to an increase in unit sales of MYOCET and the favorable effect of exchange rate changes.  In 2009, we expect Oncology sales to increase as compared to 2008 based on the growth in sales of TREANDA.

 

·                  Other sales, which consist primarily of sales of other products and certain third party products, decreased 2 percent, primarily due to a reduction in sales of third party products in the U.S.

 

Other revenues— The decrease of 31% 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 salesThe following table presents the product sales allowances deducted from gross sales to arrive at a net sales figure:

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

2008

 

2007

 

Change

 

% Change

 

Gross sales

 

$

2,226,804

 

$

1,941,097

 

$

285,707

 

15

%

Product sales allowances:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

36,855

 

31,814

 

5,041

 

16

 

Wholesaler discounts

 

13,897

 

22,172

 

(8,275

)

(37

)

Returns

 

49,159

 

14,116

 

35,043

 

248

 

Coupons

 

21,068

 

25,419

 

(4,351

)

(17

)

Medicaid discounts

 

40,923

 

37,528

 

3,395

 

9

 

Managed care and governmental contracts

 

121,438

 

82,749

 

38,689

 

47

 

 

 

283,340

 

213,798

 

69,542

 

 

 

Net sales

 

$

1,943,464

 

$

1,727,299

 

$

216,165

 

13

%

Product sales allowances as a percentage of gross sales

 

12.7

%

11.0

%

 

 

 

 

 

Prompt payment discounts, generally granted at 2% of sales, increased for the year ended December 31, 2008 as compared to the year ended December 31, 2007 due to a corresponding increase in U.S. sales that are eligible for the discount. Wholesaler discounts decreased $8.3 million period over period because cumulative price increases in 2008 produced wholesaler credits that partially offset the wholesaler discounts that would have otherwise been recorded for 2008.

 



 

Returns increased $35.0 million for the year ended December 31, 2008 as compared to the year ended December 31, 2007 as a result of heigher ACTIQ returns in the second half of 2008 and higher FENTORA returns in the fourth quarter of 2008.  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 second half of 2008 has resulted in both an increased amount of returns and a higher level of returns experience for this period.  In the fourth quarter of 2008, we experienced our first returns for FENTORA, which was launched in October 2006.  As a result, we have increased our returns percentages as it relates to current ACTIQ and FENTORA sales to more closely match this recent experience.  In 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 $4.4 million for the year ended December 31, 2008 as compared to the year ended December 31, 2007 as a result of the decrease in coupons redemption activity for FENTORA.

 

Medicaid discounts increased for the year ended December 31, 2008 as compared to the year ended December 31, 2007 due to price increases, offset by the lower Medicaid utilization of our CNS and Pain products.  Managed care and governmental contracts increased for the year ended December 31, 2008 as compared to the year ended December 31, 2007 due to new managed care contracts related to PROVIGIL as well as additional utilization and 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 $15.8 million as of December 31, 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 slightly decrease due to a stabilization of our returns experience for our Pain products and change in our sales mix to products with lower utilizations in certain managed care and governmental programs.

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

2008

 

As adjusted
2007(3)

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

412,234

 

$

345,691

 

$

66,543

 

19

%

Research and development

 

362,208

 

369,115

 

(6,907

)

(2

)

Selling, general and administrative

 

840,873

 

735,799

 

105,074

 

14

 

Settlement reserve

 

7,450

 

425,000

 

(417,550

)

(98

)

Restructuring charge

 

8,415

 

 

8,415

 

 

Impairment charge

 

99,719

 

 

99,719

 

 

Acquired in-process research and development

 

41,955

 

 

41,955

 

 

Loss on sale of equipment

 

17,178

 

1,022

 

16,156

 

1,581

 

 

 

$

 1,790,032

 

$

1,876,627

 

$

(86,595

)

(5

)%

 


(3) As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 of the Consolidated Financial Statements for additional information.

 

Cost of sales—Cost of sales was 21.2% of net sales for the year ended December 31, 2008 and 20.0% of net sales for the year ended December 31, 2007. For the years ended December 31, 2008 and 2007, we recognized $100.7 million and $90.5 million, respectively, of amortization expense included in cost of sales.  The remainder of this fluctuation is primarily due to the following factors:  the recording of a reserve for excess modafinil purchase commitments of $26.0 million in the third quarter of 2008 based on our analysis of estimated future requirements; the favorable mix of product margins for certain of our product sales for the year ended December 31, 2008 as compared to the year ended December 31, 2007 due to price increases on several of our U.S. products; and a charge of $3.5 million in the first quarter of 2007 for the termination of a materials supply agreement.  In addition, we recorded accelerated depreciation charges within cost of sales for the year ended December 31, 2008 of $7.0 million related to restructuring at our CIMA facility and $5.4 million related to the proposed divestiture of our Mitry-Mory manufacturing site.

 

Research and development expenses—Research and development expenses decreased $6.9 million, or 2%, for the year ended December 31, 2008 as compared to the year ended December 31, 2007. For the years ended December 31, 2008 and 2007, we recognized $6.0 million and $43.5 million, respectively, in up-front and milestone payments primarily related to rights acquired to certain development stage products.  The decrease in up-front and milestone payments from 2007 to 2008 was partially offset by increased clinical activity during 2008 primarily related to NUVIGIL. For the years ended

 



 

December 31, 2008 and 2007, we recognized $24.3 million and $20.6 million of depreciation expense included in research and development expenses, respectively.

 

Selling, general and administrative expenses—Selling, general and administrative expenses increased $105.1 million, or 14%, for the year ended December 31, 2008 as compared to the year ended December 31, 2007 primarily due to increased sales and marketing spending on TREANDA and AMRIX, expenses incurred under our agreements with Takeda and the elimination of reimbursements to Alkermes related to the termination of our VIVITROL promotion agreement as well as $28.2 million of expenses in the second half of 2008 related to the termination of our co-promotion agreement with Takeda, and $12.2 million of expenses in the fourth quarter of 2008 related to the termination of our collaboration with Alkermes.  These increases were offset by reduced spending on FENTORA marketing expenses and a reduction in continuing medical education grants for our existing products.  For the years ended December 31, 2008 and 2007, we recognized $20.7 million and $12.7 million, respectively, of depreciation expense included in selling, general and administrative expenses.

 

Settlement reserve— For the year ended December 31, 2008, we recognized $7.4 million for the charges relating to the settlement of investigations by the states of Connecticut and Massachusetts, including $0.6 million for attorneys’ fees for the Relators, as part of the U.S. Attorney’s Office settlement.  For the year ended December 31, 2007, we recorded a settlement reserve of $425.0 million related to the terms of the agreement in principle reached with the U.S. Attorney’s Office.  See Note 15 of the Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

 

Restructuring charges- For the year ended December 31, 2008, we recorded $8.4 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.

 

Impairment charge— For the year ended December 31, 2008 we recorded a $99.7 million impairment charge consisting of the write-off of the net book value of the VIVITROL intangible assets of $90.4 million as a result of the termination of our collaboration with Alkermes and a $9.3 million impairment charge for the write-down to fair value of Acusphere’s long-lived assets.

 

Acquired in-process research and development expense- For the year ended December 31, 2008, we recorded acquired in-process research and development expense of $27.0 million for Acusphere and $15.0 million related to LUPUZOR, a compound in phase IIb testing for the treatment of systemic lupus erythematosus, not yet approved by the FDA.

 

Loss on sale of equipment- For the year ended, December 31, 2008, we recorded a $17.2 million loss on sale of equipment related to the termination of our collaboration with Alkermes.

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

As Adjusted
2008(1)

 

As Adjusted
2007(1)

 

Change

 

% Change

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

$

16,901

 

$

32,816

 

$

(15,915

)

(48

)%

Interest expense

 

(75,233

)

(70,866

)

(4,367

)

6

 

Gain on extinguishment of debt

 

 

5,319

 

(5,319

)

 

Gain on sale of investment

 

 

5,791

 

(5,791

)

 

Other income (expense), net

 

7,880

 

7,653

 

227

 

3

 

 

 

$

 (50,452

)

$

(19,287

)

$

(31,165

)

(162

)%

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

 

Other income (expense)—Other income (expense) decreased $31.2 million, or (162)%, for the year ended December 31, 2008 as compared to the year ended December 31, 2007. The decrease was attributable to the following factors:

 

·                  a decrease in interest income for the year ended December 31, 2008 due to lower investment returns, partially offset by higher average investment balances;

 

·                  an 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 offset by a decrease in interest expense related to our convertible debt

 



 

of $4.4 million due to the redemption of our Zero Coupon Convertible Subordinated Notes due June 2033 in June 2008;

 

·                  a $5.3 million gain on extinguishment of debt related to the Pennsylvania Industrial Development Board loan forgiveness in 2007; and

 

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

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

2008(1)

 

As Adjusted
2007(1), (3)

 

Change

 

% Change

 

Income tax expense (benefit)

 

$

(37,819

)

$

103,153

 

$

(140,972

)

(137

)%

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

(3) As adjusted for change in accounting method.  See Note 1 of the Consolidated Financial Statements.

 

Income Taxes— For the year ended December 31, 2008, we recognized $37.8 million of income tax benefit on income of $134.1 million, resulting in an overall effective tax rate of (28.2) percent.  This includes a tax benefit of $82.3 million related to the settlement with the U.S. Attorney’s Office, for which the related expense was recorded in 2007 and a net release of $11.1 million reserves related to the settlement of the company’s 2003-2005 IRS audit.  This compared to income tax expense for the year ended December 31, 2007 of $103.2 million on a loss before income taxes of $123.3 million. During 2007, Cephalon did not recognize a tax benefit for the U.S. Attorney’s Office settlement reserve of $425.0 million due to the uncertainty associated with the tax treatment of any potential settlement.  See Note 16 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for a reconciliation of the United States Federal statutory rate to our effective tax rate.

 

Year ended December 31, 2007 compared to year ended December 31, 2006:

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

 

 

2007

 

2006

 

% Increase (Decrease)

 

 

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

801,639

 

$

50,408

 

$

852,047

 

$

691,779

 

$

43,052

 

$

734,831

 

16

%

17

%

16

%

GABITRIL

 

50,642

 

6,668

 

57,310

 

54,971

 

4,316

 

59,287

 

(8

)

54

 

(3

)

CNS

 

852,281

 

57,076

 

909,357

 

746,750

 

47,368

 

794,118

 

14

 

20

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

199,407

 

40,665

 

240,072

 

550,390

 

27,252

 

577,642

 

(64

)

49

 

(58

)

Generic OTFC

 

129,033

 

 

129,033

 

54,801

 

 

54,801

 

135

 

 

135

 

FENTORA

 

135,136

 

 

135,136

 

29,250

 

 

29,250

 

362

 

 

362

 

AMRIX

 

8,401

 

 

8,401

 

 

 

 

100

 

 

100

 

Pain

 

471,977

 

40,665

 

512,642

 

634,441

 

27,252

 

661,693

 

(26

)

49

 

(23

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

16,561

 

76,316

 

92,877

 

12,617

 

63,425

 

76,042

 

31

 

20

 

22

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

52,702

 

159,721

 

212,423

 

43,467

 

144,852

 

188,319

 

21

 

10

 

13

 

Total Sales

 

1,393,521

 

333,778

 

1,727,299

 

1,437,275

 

282,897

 

1,720,172

 

(3

)

18

 

 

Other Revenues

 

40,149

 

5,190

 

45,339

 

35,399

 

8,498

 

43,897

 

13

 

(39

)

3

 

Total Revenues

 

$

1,433,670

 

$

338,968

 

$

1,772,638

 

$

1,472,674

 

$

291,395

 

$

1,764,069

 

(3

)%

16

%

%

 

Sales—In the United States, we sell our proprietary products to pharmaceutical wholesalers, the largest three of which accounted for 66% and 71% of our total consolidated gross sales for the years ended December 31, 2007 and 2006, respectively. 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 December 31, 2007, 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 did not independently verify, we believe that total inventory held at these wholesalers was approximately two weeks supply of our U.S. branded products at our then current sales levels. At December 31, 2007, we believed that inventory held at wholesalers and retailers of our generic OTFC product, launched in October 2006, was approximately three months supply.

 

For the year ended December 31, 2007, sales were impacted by 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 year ended December 31, 2007, total sales remained consistent over the prior year. The other key factors that contributed to the changes in sales are summarized by product as follows:

 

·                  In CNS, sales of PROVIGIL increased 16 percent. Demand for PROVIGIL increased as evidenced by an increase in U.S. prescriptions for PROVIGIL of 9%, according to IMS Health. For the year ended December 31, 2007, sales of PROVIGIL also were impacted by domestic price increases of 5% from period to period.  European sales increased due to the favorable effect of exchange rate changes, stronger sales in substantially all territories and higher prices for GABITRIL.

 

·                  In Pain, sales decreased 23 percent. Sales of ACTIQ were impacted by an increase in domestic prices of 48% from period to period, offset by an 81% decrease in U.S. prescriptions, according to IMS Health. For the year ended December 31, 2007, we recognized $129.0 million of revenue related to sales of our own generic OTFC and shipments of our generic OTFC to Barr, as compared to $54.8 million in 2006 following our launch of generic OTFC in late September 2006.  We recognized $135.1 million of revenue related to sales of FENTORA for the year ended December 31, 2007, as compared to $29.3 million in 2006 following the launch of the product in October 2006.  We also recognized $8.4 million of revenue related to sales of AMRIX. European sales of ACTIQ were favorably impacted by the efforts of our co-promotion partner in France that started during 2006 and the favorable effect of exchange rate changes.

 

·                  Other sales, including oncology, which consist primarily of sales of other products and certain third party products, increased 15 percent. The increase is attributable to an increase of $27.8 million in sales of our European products, primarily driven by sales in France and sales of oncology products in Europe and the favorable effect of exchange rate changes. In addition, other sales in the U.S. increased $13.2 million, primarily driven by increases in sales of VIVITROL and TRISENOX.

 

Other Revenues— The increase of 3% from period to period is primarily due to an increase in revenues from our collaborators including royalties, milestone payments and fees.

 

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

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

2007

 

2006

 

Change

 

% Change

 

Gross sales

 

$

1,941,097

 

$

1,890,836

 

$

50,261

 

3

%

Product sales allowances:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

31,814

 

32,384

 

(570

)

(2

)

Wholesaler discounts

 

22,172

 

2,939

 

19,233

 

654

 

Returns

 

14,116

 

24,735

 

(10,619

)

(43

)

Coupons

 

25,419

 

26,853

 

(1,434

)

(5

)

Medicaid discounts

 

37,528

 

45,267

 

(7,739

)

(17

)

Managed care and governmental contracts

 

82,749

 

38,486

 

44,263

 

115

 

 

 

213,798

 

170,664

 

43,134

 

 

 

Net sales

 

$

1,727,299

 

$

1,720,172

 

$

7,127

 

%

Product sales allowances as a percentage of gross sales

 

11.0

%

9.0

%

 

 

 

 

 

Prompt payment discounts, generally granted at 2% of sales, decreased for the year ended December 31, 2007 as compared to the year ended December 31, 2006 due to a decrease in U.S. sales that are eligible for the discount. Wholesaler discounts increased $19.2 million period over period because cumulative price increases as of December 31, 2006 produced

 



 

wholesaler credits that significantly offset the wholesaler discounts that would have been recorded for 2006.  Returns decreased as a result of our historical returns experience, particularly related to our CNS products, which is used in the calculation of our returns reserve requirements and due to an overall decrease in U.S. sales.  Coupons decreased for the year ended December 31, 2007 as compared to the year ended December 31, 2006 as a result of the elimination and expiration of ACTIQ coupons on September 30, 2006, offset by the distribution of coupons for FENTORA, which was launched in October 2006.

 

Medicaid discounts decreased for the year ended December 31, 2007 as compared to the year ended December 31, 2006 due to the lower sales and Medicaid utilization of our Pain products, particularly branded ACTIQ, offset by an increase in the reimbursement rate for ACTIQ and generic OTFC as a result of the application of the provisions of the Deficit Reduction Act of 2005 effective October 1, 2007.  Managed care and governmental contracts increased for the year ended December 31, 2007 as compared to the year ended December 31, 2006 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 reduction in the managed care and governmental contracts allowance of $13.3 million in the third quarter of 2006, representing amounts paid to the U.S. Department of Defense (“DoD”) under the Tricare program from October 2004 through June 30, 2006. In October 2006, the DoD announced that it would reimburse all companies that had voluntarily made such payments under the Tricare program due to the U.S. Court of Appeals September 2006 ruling.

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

As adjusted
2007*

 

As adjusted
2006*

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

 345,691

 

$

 336,110

 

$

 9,581

 

3

%

Research and development

 

369,115

 

424,239

 

(55,124

)

(13

)%

Selling, general and administrative

 

735,799

 

689,492

 

46,307

 

7

%

Settlement reserve

 

425,000

 

 

425,000

 

%

Impairment charge

 

 

12,417

 

(12,417

)

(100

)%

Acquired in-process research and development

 

 

5,000

 

(5,000

)

(100

)%

Loss on sale of equipment

 

1,022

 

 

1,022

 

%

 

 

$

 1,876,627

 

$

 1,467,258

 

$

 409,369

 

28

%

 


* As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 of the Consolidated Financial Statements for additional information.

 

Cost of Sales—The cost of sales was 20.0% of net sales for the year ended December 31, 2007 and 19.5% of net sales for the year ended December 31, 2006.  For the years ended December 31, 2007 and 2006, we recognized $90.5 million and $81.7 million of amortization expense included in cost of sales, respectively.  The remainder of this fluctuation is primarily due to the following factors: lower royalty expenses for ACTIQ resulting from the decline in the royalty rate upon the expiration of the ACTIQ patents in September 2006; the favorable mix of product margins for certain of our product sales for the year ended December 31, 2007 as compared to the year ended December 31, 2006, offset by a decrease in product margin for our Pain products resulting from the shift in market share from ACTIQ to generic OTFC; the net effect of price increases in 2006 on U.S. products; an $8.6 million inventory reserve related to SPARLON™ (modafinil) Tablets [C-IV] recorded in the second quarter of 2006; and a charge of $3.5 million in the first quarter of 2007 for the termination of a materials supply agreement.

 

Research and Development Expenses—Research and development expenses decreased $55.1 million, or 13%, for the year ended December 31, 2007 as compared to the year ended December 31, 2006. For the years ended December 31, 2007 and 2006, we recognized $28.5 million and $80.5 million, respectively, in up-front payments related to rights acquired to certain development stage products.  We also recognized a $15.0 million milestone payment related to our NDA filing for TREANDA in the third quarter of 2007.  This decrease is also attributable to lower expenses associated with reduced levels of clinical activity in 2007 as compared to 2006.  For the years ended December 31, 2007 and 2006, we recognized $20.6 million and $20.9 million of depreciation expense included in research and development expenses, respectively.

 

Selling, General and Administrative Expenses—Selling, general and administrative expenses increased $46.3 million, or 7%, for the year ended December 31, 2007 as compared to the year ended December 31, 2006 primarily due to the cessation of the reimbursement of expenses from Alkermes related to the promotion of VIVITROL of $23.8 million, increased sales and marketing spending on oncology products, expenses incurred under our agreements with Takeda and Watson and $7.2 million

 



 

for severance costs primarily related to the reorganization of our sales force.  These increases were offset by reduced spending on marketing expenses and continuing medical education grants for our existing products and $6.0 million of one-time payments made for the year ended December 31, 2006 in connection with PROVIGIL settlement agreements.  For the years ended December 31, 2007 and 2006, we recognized $12.7 million and $13.9 million of depreciation expense included in selling, general and administrative expenses, respectively.

 

Settlement Reserve—For the year ended December 31, 2007, we recorded a settlement reserve of $425.0 million related to the terms of the agreement in principle reached with the U.S. Attorney’s Office.  See Note 15 of the Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

 

Impairment charge—In June 2006, we announced that data from our Phase III clinical program evaluating GABITRIL for the treatment of generalized anxiety disorder (“GAD”) did not reach statistical significance on the primary study endpoints. As a result, we performed a test of impairment on the carrying value of our investment in GABITRIL product rights and recorded an impairment charge of $12.4 million in the second quarter of 2006 related to our European rights.

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

As Adjusted
2007(1)

 

As Adjusted
2006(1)

 

Change

 

%
Change

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

$

32,816

 

$

25,438

 

$

7,378

 

29

%

Interest expense

 

(70,866

)

(87,805

)

16,939

 

(19

)

Debt exchange expense

 

 

(41,106

)

41,106

 

100

 

Gain on extinguishment of debt

 

5,319

 

 

5,319

 

 

Gain on sale of investment

 

5,791

 

 

5,791

 

 

Other income (expense), net

 

7,653

 

(1,172

)

8,825

 

753

 

 

 

$

 (19,287

)

$

(104,645

)

$

85,358

 

82

%

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

 

Other Income (Expense)—Other income (expense) increased $85.4 million, or 82%, for the year ended December 31, 2007 as compared to the year ended December 31, 2006. The increase was attributable to the following factors:

 

·                  an increase in interest income for the year ended December 31, 2007 due to higher average investment balances;

 

·                  a $16.9 million reduction in interest expense due to the conversion of $100.0 million of 2.0% Notes in December 2006;

 

·                  a $41.1 million charge resulting from the exchange of $336.9 million of Zero Coupon Notes and $100.0 million of 2.0% Notes in December 2006;

 

·                  a $5.3 million gain on extinguishment of debt related to the Pennsylvania Industrial Development Board loan forgiveness in 2007;

 

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

 

·                  a $8.8 million increase in other income (expense), net primarily due to fluctuations in foreign currency gains and losses in the comparable periods.

 

 

 

Year Ended December 31,

 

 

 

 

 

 

 

As Adjusted
2007(1), (3)

 

As Adjusted
2006(1), (3)

 

Change

 

% Change

 

Income tax expense

 

$

103,153

 

$

76,524

 

$

26,629

 

35

%

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

(3) As adjusted for change in accounting method.  See Note 1 of the Consolidated Financial Statements for additional information.

 



 

Income Taxes—For the year ended December 31, 2007, we recognized $103.2 million of income tax expense on loss before income taxes of $123.3 million, as we have not yet recognized a tax benefit for the $425.0 million settlement reserve recorded as of December 31, 2007 due to the uncertainty associated with the tax treatment of the settlement.  This compared to income tax expense for the year ended December 31, 2006 of $76.5 million on income before income taxes of $192.2million, resulting in an effective tax rate of 39.8 percent. See Note 16 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for a reconciliation of the United States Federal statutory rate to our effective tax rate.

 

LIQUIDITY AND CAPITAL RESOURCES

(In thousands, except per share data)

 

 

 

As of December 31,

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted 2007(1), (2)

 

As Adjusted 2006(1), (2)

 

Financial assets:

 

 

 

 

 

 

 

Cash and cash equivalents and investments

 

$

524,459

 

$

818,669

 

$

496,512

 

Investments

 

 

7,596

 

25,212

 

Total financial assets (current)

 

$

524,459

 

$

826,265

 

$

521,724

 

Debt and redeemable equity:

 

 

 

 

 

 

 

Current portion of long-term debt- convertible notes

 

$

1,019,888

 

$

1,233,370

 

$

1,019,716

 

Current portion of long-term debt discount- convertible notes

 

(248,403

)

(292,510

)

(322,238

)

Current portion of long-term debt- other debt

 

10,133

 

3,799

 

3,596

 

Long-term debt- convertible notes

 

 

 

213,417

 

Long-term debt discount- convertible notes

 

 

 

(18,097

)

Long-term debt- other debt

 

3,692

 

3,788

 

11,575

 

Redeemable equity

 

248,403

 

292,510

 

322,238

 

Total debt and redeemable equity

 

$

1,033,713

 

$

1,240,957

 

$

1,230,207

 

 

 

 

 

 

 

 

 

Select measures of liquidity and capital resources:

 

 

 

 

 

 

 

Working capital surplus (deficit)

 

$

156,410

 

$

(285,708

)

$

45,295

 

Cash/cash equivalents/investments as a percent of total assets

 

17

%

24

%

18

%

 

 

 

Year Ended December 31,

 

 

 

2008

 

2007

 

2006

 

Change in cash and cash equivalents

 

 

 

 

 

 

 

Net cash provided by (used for) operating activities

 

$

(1,877

)

$

384,856

 

$

319,917

 

Net cash used for investing activities

 

(108,138

)

(172,946

)

(20,376

)

Net cash provided by (used for) financing activities

 

(172,894

)

96,935

 

(22,624

)

Effect of exchange rate changes on cash and cash equivalents

 

(11,301

)

13,312

 

14,535

 

Net increase (decrease) in cash and cash equivalents

 

$

(294,210

)

$

322,157

 

$

291,452

 

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”  See Note 1 of the Consolidated Financial Statements for additional information.

 

(2) As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”  See Note 1 of the Consolidated Financial Statements for additional information.

 

Our working capital deficit is calculated as current assets less current liabilities.  The fluctuation in the working capital deficit between the three periods was primarily driven by the change in accrued expenses year over year as a result of the settlement agreement reached in 2007 with the U.S. Attorney’s Office for $425.0 million, which was paid in 2008. 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.

 

On August 15, 2008, we established a $200 million, three-year revolving credit facility (the “Credit Agreement”) 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 customary 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 filing of this Annual Report on Form 10-K, we have not drawn any amounts under the credit facility.

 

Net Cash Provided by (Used for) Operating Activities

 

For all periods presented, cash provided by operating activities is driven by income from sales of our products offset by the timing of receipts and payments in the ordinary course of business.  Net cash used for operating activities was $1.9 million in 2008 as compared to net cash provided by operating activities of $384.9 million in 2007.  The $386.7 million decrease in 2008 is primarily attributable to the payment of $425.0 million in association with the settlement agreement with the U.S. Attorney’s Office.  Material non-cash items impacting 2008 cash flows from operating activities include:

 

·                  In association with the termination agreement with Alkermes, we recorded an impairment charge of $90.4 million during 2008 to write-off the net book value of the VIVITROL intangible assets and a loss of $17.2 million upon the sale of manufacturing property and equipment to Alkermes with the corresponding proceeds received reflected within investing activities.

 

·                  As a result of consolidating Acusphere’s results in our consolidated statements of cash flows for 2008, we have an adjustment in cash provided by operating activities of $17.0 million related to the write-off of IPR&D acquired as a result of the Acusphere transaction.

 

The net loss for the year ended December 31, 2007 was offset by changes in accounts payable and accrued expenses resulting from the agreement in principle with the U.S. Attorney’s Office, for which $425 million was accrued but not paid.  Net cash used for operating activities was $384.9 million in 2007 as compared to $319.9 million in 2006.  In 2006, we experienced growth in operating income due to increased income from sales of PROVIGIL, ACTIQ and other key products.

 

Net Cash Used for Investing Activities

 

Cash used for investing activities primarily relates to acquisitions of business, technologies, products and product rights and funds used for capital expenditures in property and equipment. These uses of cash are offset by sales, maturities or purchases of investments associated with our portfolio of available-for-sale investments.

 

Net cash used for investing activities was $108.1 million in 2008 as compared to $172.9 million in 2007.  The change between periods is primarily attributable to:

 

·                  a $81.4 million increase in cash flow from lower expenditures on intangible assets in 2008 as compared to 2007. 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 exclusive North American rights to AMRIX from E. Claiborne Robins Company Inc.;

 

·                  a $21.0 million increase in cash flow from lower capital expenditures in 2008 as compared to 2007;

 

·                  a $16.0 million increase in cash flow from proceeds received from Alkermes related to the sale of manufacturing property and equipment in 2008;

 

·                  a $31.7 million decrease in cash flow for investments in third parties including an equity investment of $6.2 million in a privately-held pharmaceutical company paid during the second quarter of 2008 and $25 million paid in the fourth quarter of 2008 as consideration for exclusive rights to negotiate an option to purchase Ception;

 

·                  a $12.3 million decrease in cash flow for proceeds from the sale of an investment in 2007; and

 

·                  a $11.3 million decrease in cash provided from sales and maturities of our investment portfolio. During 2008, all available-for-sale instruments in our investment portfolio were sold or 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.

 

Net cash used for investing activities was $172.9 million in 2007 as compared to $20.4 million in 2006.  The change between periods is primarily attributable to:

 

·                  a $236.5 million decrease in cash flow mainly stemming from the sale of marketable securities in 2006;

 



 

·                  a $63.0 million increase in cash flow from lower capital expenditures in 2007 as compared to 2006;

 

·                  a $12.3 million increase in cash flow for proceeds from the sale of an investment in 2007; and

 

·                  a $8.6 million increase in cash flow from lower expenditures on intangible assets in 2007 as compared to 2006.  Cash used for intangible assets includes $99.2 million paid in August 2007 in association with the acquisition of the exclusive North American rights to AMRIX from E. Claiborne Robins Company Inc. and $110.0 million paid to Alkermes in 2006 following FDA approval of VIVITROL.

 

Net Cash Provided by (Used for) Financing Activities

 

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

 

Net cash used for financing activities was $172.9 million in 2008 as compared to net cash provided by financing activities of $96.9 million in 2007.  The change is primarily attributable to the payment in 2008 of $213.1 million upon conversion or redemption of our 2008 Zero Coupon Convertible Notes. Proceeds from stock options exercises in 2008 and 2007 were $44.0 million and $93.9 million, respectively.

 

Net cash provided by financing activities was $96.9 million in 2007 as compared to net cash used for financing activities of $22.7 million in 2006.  The change is primarily attributable to the payment in 2006 of $175.3 million in connection with our exchange of $437.3 million of our outstanding convertible notes for cash and common stock and the retirement in 2006 of the remaining obligation of $10.0 million of our 2.5% Notes due December 2006. Proceeds from stock options exercises in 2007 and 2006 were $93.9 million and $143.5 million, respectively.

 

Commitments and Contingencies

 

—Legal Proceedings

 

For a complete description of legal proceedings, see Note 15 of the Consolidated Financial Statements.

 

—Other Commitments and Contingencies

 

The following table summarizes our obligations to make future payments under current contracts:

 

 

 

Payments due by period

 

Contractual obligations

 

Total

 

2009

 

2010 and 2011

 

2012 and 2013

 

2014 and
thereafter

 

Debt obligations

 

$

2,664

 

$

1,678

 

$

986

 

$

 

$

 

Convertible notes and redeemable equity

 

1,019,924

 

1,019,924

 

 

 

 

Purchase obligations

 

91,044

 

41,000

 

43,685

 

6,339

 

20

 

Capital lease obligations

 

2,229

 

1,293

 

936

 

 

 

Interest payments on debt

 

106,871

 

16,594

 

32,877

 

32,800

 

24,600

 

Operating leases

 

94,450

 

18,379

 

27,122

 

19,288

 

29,661

 

Pension obligations

 

9,580

 

251

 

587

 

1,771

 

6,971

 

Total contractual obligations

 

$

1,326,762

 

$

1,099,119

 

$

106,193

 

$

60,198

 

$

61,252

 

 

As of December 31, 2008, all of our notes are convertible because the closing price of our common stock on that date was higher than the restricted conversion prices of these notes. As a result, such notes have been classified as current liabilities and redeemable equity on our consolidated balance sheet as of December 31, 2008 and are therefore included under the 2009 column in the table above.  For a discussion of our obligations under our convertible notes, see “—Outlook—Indebtedness” below.

 

In addition to the above, we have committed to make potential future “milestone” payments to third parties as part of our in-licensing and development programs primarily in the area of research and development agreements. Payments generally become due and payable only upon the achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, we have not recorded a liability on our balance sheet for any such contingencies. As of December 31, 2008, the potential milestone and other contingency payments due under current contractual agreements are $701.7 million.

 



 

The table above excludes (i) our non-current liability for net unrecognized tax benefits, which totaled $61.2 million as of December 31, 2008, since we cannot predict with reasonable reliability the timing of cash settlements to the respective taxing authorities and (ii) contractual obligations of our variable interest entities for intellectual property rights, equipment financing, construction financing and lease obligations as our variable interest entities creditors have no recourse to the general credit of Cephalon.

 

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, technologies, property, plant and equipment, 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 2009. 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.

 

Based on our current level of operations, projected sales of our existing products and estimated sales from our product candidates, if approved, combined with other revenues and interest income, we also believe that we will be able to service our existing debt and meet our capital expenditure and working capital requirements in the near term. We do not expect any material changes in our capital expenditure spending during 2009. 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.

 

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 acquisitions and it may be necessary for us 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 or closure costs.

 

In 2009, we have incurred cash charges of $75 million and $30 million, respectively, related to our option agreements with Ception Therapeutics, Inc. and ImmuPharma PLC.  For a complete description of these transactions, see Note 19 of the Consolidated Financial Statements.

 

In 2009, we received $67.3 million in federal tax refunds of previously paid 2008 estimated federal taxes. This refund was principally due to the tax benefit relating to the termination of our collaboration with Alkermes for the marketing and sale of VIVITROL and the settlement with the U.S. Attorney’s Office.

 

Marketed Products and Product Candidates

 

Sales growth of our modafinil-based products 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 through its expiration beginning in 2014 and our NUVIGIL polymorph patent through its expiration beginning in 2023. See Note 15 of the Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.  During 2008, we experienced a 2% decline in prescription growth of PROVIGIL.  We have undertaken a number of initiatives, including changes to our sales force and the continuation of direct-to-consumer print and web-based advertising that we believe will stimulate prescription growth.  Finally, growth of our modafinil-based product sales in the future may depend in part on our ability to successfully launch NUVIGIL in the third quarter of 2009.  We expect that upon the launch of NUVIGIL, our marketing efforts with respect to PROVIGIL will decline substantially and will shift to NUVIGIL.  Currently, we do not believe 2009 CNS net sales will be adversely impacted as compared to 2008 by the decline in PROVIGIL marketing efforts associated with the launch of NUVIGIL.

 

Our future growth depends in large 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 Barr, Mylan and Impax.

 



 

Our future growth also depends, in 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.  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. In May 2008, an FDA Advisory Committee voted not to recommend approval of the FENTORA sNDA.  In September 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 December 2008, we also received a supplement request letter from the FDA requesting that we submit a Risk Evaluation and Mitigation Strategy (the “REMS Program”) with respect to FENTORA, which we expect to file with the FDA by the end of the first quarter of 2009.  In the December 2008 supplement request letter, the FDA also provided guidance for the design and implementation of the REMS Program to mitigate serious risks associated with the use of FENTORA.  To address the FDA’s requests in its September 2008 and December 2008 letters, we plan to implement as part of the REMS Program a first-of-its-kind initiative designed to minimize the potential risk of overdose from an opioid through appropriate patient selection.  We believe that, by working with the FDA, we can design and implement a REMS Program to meet the FDA’s requests and possibly provide a potential avenue for approval of the sNDA. We anticipate initiating the REMS Program upon receipt of approval from the FDA.  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 2009.

 

Clinical Studies

 

Over the past few years, we have incurred significant expenditures related to conducting clinical studies to develop new pharmaceutical products and to explore the utility of our existing products in treating disorders beyond those currently approved in their respective labels. In 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: studies of TREANDA as a front-line treatment for NHL and for the treatment of multiple myeloma; a Phase II program evaluating CEP-701 for the treatment of myeloproliferative disorder; and clinical programs with NUVIGIL focused on cancer related fatigue/tiredness, adjunctive treatment to atypical anti-psychotics in schizophrenia patients, bi-polar depression, treatment of obstructive sleep apnea and co-morbid depression, excessive sleepiness associated with jet lag disorder and with traumatic brain injury.

 

Manufacturing, Selling and Marketing Efforts

 

In 2009, 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 2009 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 2009 is expected to be higher than that incurred in 2008, primarily as a result of higher expenses associated with our promotional efforts related to AMRIX and TREANDA and pre-launch expenses and subsequent post-launch promotional efforts 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 third quarter 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 future purchase commitments totaling $57.8 million as of December 31, 2008.  Based on our current 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 December 31, 2008, we had $34.8 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 and Redeemable Equity

 

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 December 31, 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 12 to our Consolidated Financial Statements.

 

As of December 31, 2008, our closing stock price was $77.04, and therefore, all of our notes were convertible as of December 31, 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 Annual Report on Form 10-K, 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 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.

 

As of December 31, 2008, all of our notes are convertible because the closing price of our common stock on that date was higher than the restricted conversion prices of these notes. As a result, all notes have been classified as current liabilities on our consolidated balance sheet as of December 31, 2008.  See Note 12 to our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for summary of our convertible debt, note hedge and call warrant.  As of February 17, 2009, the fair value of both the 2.0% Notes and the 2010 Zero Coupon Notes is greater than the value of the shares into which such notes are convertible. 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 the convertible notes would be less than the value of the common stock shares underlying the notes and, as such, we believe it is highly unlikely that holders of the 2.0% Notes or the 2010 Zero Coupon Notes will present significant amounts of such notes for conversion under the current terms. In the unlikely 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 December 31, 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 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 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

 

7,497

 

1,998

 

9,495

 

(7,497

)

1,998

 

$

85.00

 

9,096

 

4,496

 

13,592

 

(9,096

)

4,496

 

$

95.00

 

10,358

 

6,468

 

16,826

 

(10,358

)

6,468

 

$

105.00

 

11,380

 

8,064

 

19,444

 

(11,380

)

8,064

 

 


(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 (the “Credit Agreement”) 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 customary 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.

 

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 U.S. GAAP. 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.

 

Our significant accounting policies are described in Note 1 to our Consolidated Financial Statements for the year ended December 31, 2008. The Securities and Exchange Commission defines critical accounting policies as those that are, in management’s view, most important to the portrayal of the company’s

 



 

financial condition and results of operations and most demanding of their judgment. Management considers the following policies to be critical to an understanding of our consolidated financial statements and the uncertainties associated with the complex judgments made by us that could impact our results of operations, financial position and cash flows.

 

Revenue recognition—In the United States, we sell our proprietary products to pharmaceutical wholesalers, the largest three of which account for 71% of our total consolidated gross sales for the year ended December 31, 2008. Decisions made by these wholesalers regarding the levels of inventory they hold (and thus the amount of product they purchase from us) may have materially affected the level of our sales in any particular period and thus our sales may not correlate to the number of prescriptions written for our products as reported by IMS Health.

 

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.

 

Product sales are recognized upon the transfer of ownership and risk of loss for the product to the customer. In the United States, we sell all commercial products F.O.B. destination. Transfer of ownership and risk of loss for the product pass to the customer at the point that the product is received by the customer. In Europe, product sales are recognized predominantly upon customer receipt of the product, except in certain contractual arrangements where different terms may be specified.

 

Payments under co-promotional or managed services agreements are recognized over the period when the products are sold or the promotional activities are performed. The portion of the payments that represent reimbursement of our expenses is recognized as an offset to those expenses in our results of operations.

 

We recognize revenue on new product launches when sales returns can be reasonably estimated and all other revenue recognition requirements have been met. When determining if returns can be estimated, we consider actual returns of similar products as well as sales returns with similar customers. In cases in which a new product is not an extension of an existing line of product or where we have no history of experience with products in a similar therapeutic category such that we can not estimate expected returns of the new product, we defer recognition of revenue until the right of return no longer exists or until we have developed sufficient historical experience to estimate sales returns. In developing estimates for sales returns, we consider inventory levels in the distribution channel, shelf life of the product and expected demand based on market data and prescriptions.

 

As of December 31, 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. At December 31, 2008, we believe that inventory held at wholesalers and retailers of our generic OTFC product, launched in October 2006, is approximately five months supply at our current sales levels.

 

In October 2007, we launched AMRIX.  Sales of AMRIX to wholesalers and retailers include the right of return of expired product.  Based on the sales levels and the prescription data during the fourth quarter of 2007, and based on the number of units on hand in the pipeline at December 31, 2007 relative to the overall demand for the products, we have estimated and recorded all applicable product sales allowances related to AMRIX as of December 31, 2007.  We have therefore recognized revenues for AMRIX based on a fixed and determinable sales price in 2007 and 2008.

 

In September 2006, we launched generic OTFC, utilizing Watson Pharmaceuticals, Inc. as our sales agent in this effort.  We pay our sales agent a commission for these services and record this commission as selling, general and administrative expense.  In October 2006, we launched FENTORA® (fentanyl buccal table) [C-II].  Sales of our generic OTFC product to wholesalers and retailers include both the right of return of expired product and retroactive price reductions under certain conditions, while sales of FENTORA also include the right of return of expired product.  Based on the sales levels and the prescription data during the fourth quarter of 2006, and based on the number of units on hand in the pipeline at December 31, 2006 relative to the overall demand for the products, we have estimated and recorded all applicable product sales allowances related to generic OTFC and FENTORA as of December 31, 2006.  We have therefore recognized revenues for generic OTFC and FENTORA based on a fixed and determinable sales price in 2006, 2007 and 2008.

 

Sales of our generic OTFC product could be subject to retroactive price reductions for units that remain in the pipeline if the price of generic OTFC is reduced, including as a result of another generic entrant into the market, and as a result any estimated impact of such adjustments is recorded at the time revenue is recognized.  This estimate of both the potential timing of a generic entrant and the amount of the price reduction is highly subjective.  At December 31, 2008, we are not aware of any expected additional entrants into the generic OTFC market that would result in a price reduction to

 



 

customers for inventory already purchased from us, and do not believe that any revenue recognized as of December 31, 2008 would be effected by a retroactive shelf stock adjustment.  If an additional generic entrant had occurred on January 1, 2009, and generic OTFC prices were reduced by 15%, then a reduction of our reported revenues of $8.8 million would result.  We utilize Watson as our sales agent for the sales and distribution of our generic OTFC.  We pay our sales agent a commission for these services and record this commission as selling, general and administrative expense.

 

Product sales allowances—We record product sales net of the following significant categories of product sales allowances: prompt payment discounts, wholesaler discounts, returns, coupons, Medicaid 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.

 

1) Prompt payment discounts—We offer our U.S. wholesaler customers a 2% prompt-pay cash discount as an incentive to remit payment within the first thirty-five days after the date of the invoice. Prompt-pay discount calculations are based on the gross amount of each invoice. We account for these discounts by reducing sales by the 2% discount amount when product is sold, and apply earned cash discounts at the time of payment. Since we began selling our products commercially in 1999, our customers have routinely taken advantage of this discount. Based on common industry practices and our customers’ overall payment performance, we accrue for cash discounts on all U.S. sales recorded during the period. We adjust the accrual to reflect actual experience as necessary and, as a result, the actual amount recognized in any period may be slightly different from our accrual amount.

 

2) Wholesaler discounts—We have distribution service agreements with a number of our wholesaler customers that provide our wholesalers with the opportunity to earn up to 2% in additional discounts in exchange for the performance of certain services. We have therefore recorded a provision equal to 2% of U.S. gross sales for the twelve months ended December 31, 2008, less inventory appreciation adjustments for 2008 price increases. In addition, at our discretion, we may provide additional discounts to wholesalers such as the additional discount offered to wholesalers on initial stocking orders of FENTORA and AMRIX. Actual discounts provided could therefore exceed historical experience and our estimates of expected discounts. If these discounts were to increase by 1.0% of 2008 gross sales from our proprietary products marketed in the U.S., then an additional provision of $16.4 million would result.

 

3) 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 year ended December 31, 2008, we recorded a provision for returns at a weighted average rate of 2.2% of gross sales, which is an increase over our actual historical return percentages. Returns increased for the year ended December 31, 2008 as compared to the year ended December 31, 2007 as a result of heightened ACTIQ returns in the second half of 2008 and higher FENTORA returns in the fourth quarter of 2008.  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 second half of 2008 has resulted in both an increased amount of returns and a higher level of returns experience for this period.  In the fourth quarter of 2008, we experienced our first returns for FENTORA, which was launched in October 2006, at a level higher than originally expected.  As a result, we have adjusted our returns percentages as it relates to current ACTIQ and FENTORA sales to more closely match this recent experience.  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 0.5% of 2008 gross sales from our proprietary products marketed in the U.S., then an additional provision of $8.2 million would result.

 

Based on fourth quarter sales, we believe a reasonable estimate of our maximum exposure for potential returns related to product in our total supply pipeline as of December 31, 2008 is $342.9 million.

 



 

4) Coupons—We offer patients the opportunity to obtain free samples of our products through a program whereby physicians provide coupons to qualified patients for redemption at retail pharmacies. We reimburse retail pharmacies for the cost of these products through a third party administrator. We recognize the estimated cost of this reimbursement as a reduction of gross sales when product is sold. In addition, we maintain an accrual for unused coupons based on inventory in the distribution channel and historical coupon usage rates and adjust this accrual whenever changes in such coupon usage rates occur.

 

For the year ended December 31, 2008, we recorded a provision for coupons at a weighted average rate of 0.9% of gross sales. Actual coupon usage could exceed historical experience and our estimates of expected future coupon activity. If the coupons provision percentage were to increase by 0.5% of 2008 gross sales from our proprietary products marketed in the U.S., then an additional provision of $8.2 million would result.

 

5) Medicaid discounts—We record accruals for rebates to be provided through governmental rebate programs, such as the Medicaid Drug Rebate Program, as a reduction of sales when product is sold. These reductions are based on historical rebate amounts and trends of sales eligible for these governmental programs for a period, as well as any expected changes to the trends of our total product sales. In addition, we estimate the expected unit rebate amounts to be used and adjust our rebate accruals based on the expected changes in rebate pricing. Rebate amounts are generally invoiced and paid quarterly in arrears, so that our accrual consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual for prior quarters’ unpaid rebates and an accrual for inventory in the distribution channel.

 

For the year ended December 31, 2008, we recorded a provision for Medicaid discounts at a weighted average rate of 1.8% of gross sales. Actual Medicaid discounts could exceed historical experience and our estimates of expected future Medicaid patient activity or unit rebate amounts. If the Medicaid discounts provision percentage were to increase by 0.5% of 2008 gross sales from our proprietary products marketed in the U.S., then an additional provision of $8.2 million would result.

 

6) Managed care and governmental contracts—We have entered into agreements with certain managed care customers whereby we provide agreed-upon discounts to such entities based on market share. We record accruals for these discounts as a reduction of sales when product is sold based on the discount rates and expected levels of market share of these managed care customers during a period. We estimate eligible sales based on historical amounts and trends of sales by these entities and on any expected changes to the trends of our product sales. Discounts are generally invoiced and paid quarterly in arrears, so that our accrual consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual for prior quarters’ unpaid rebates and an accrual for inventory in the distribution channel.

 

We have entered into agreements with certain governmental customers (other than Medicaid) whereby we provide legislatively mandated discounts and rebates to such entities. We record accruals for these discounts and rebates as a reduction of sales when product is sold based on the discount amounts and expected levels of performance of these governmental customers during a period. We estimate eligible sales based on historical sales amounts and trends of sales by these entities and on any expected changes to the trends of our product sales. Generally, discounts are granted to governmental customers by our wholesalers at time of purchase. In other cases, rebates are paid directly to governmental customers based on reported levels of patient usage. Wholesalers charge these discounts and rebates back to us generally within one to three months. We record accruals for our estimate of unprocessed chargebacks related to sales made during the period based on an estimate of the amount expected to be incurred for the current quarter’s sales, plus an accrual based on the amount of inventory in the distribution channel.

 

We recognized a reduction in the managed care and governmental contracts allowance of $13.3 million in the third quarter of 2006, representing amounts paid to the DoD under the Tricare program from October 2004 through June 30, 2006. In October 2006, the DoD announced that it would reimburse all companies that had voluntarily made such payments under the Tricare program due to the U.S. Court of Appeals September 2006 ruling and we received this reimbursement in December 2006. We recognized a reserve of $15.8 million as of December 31, 2008 for amounts payable to the U.S. Department of Defense (“DoD”) under the new Tricare program effective January 28, 2008.

 

For the year ended December 31, 2008, we recorded a provision for managed care and governmental contracts at a weighted average rate of 5.4% of gross sales. Actual chargebacks and rebates could exceed historical experience and our estimates of expected future participation in these programs. If the chargebacks and rebates provision percentage were to increase by 0.5% of 2008 gross sales from our proprietary products marketed in the U.S., then an additional provision of $8.2 million would result.

 

The following table summarizes activity in each of the above categories for the years ended December 31, 2007 and 2008:

 



 

 

 

Prompt
Payment
Discounts

 

Wholesaler
Discounts

 

Returns*

 

Coupons

 

Medicaid
Discounts

 

Managed
Care &
Governmental
Contracts

 

Total

 

Balance at January 1, 2007

 

$

 (3,548

)

$

 (310

)

$

 (28,843

)

$

 (4,662

)

$

 (26,402

)

$

 (19,495

)

$

 (83,260

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(31,819

)

(22,172

)

(16,793

)

(25,591

)

(37,681

)

(82,958

)

(217,014

)

Prior periods

 

5

 

 

2,677

 

172

 

153

 

209

 

3,216

 

Total

 

(31,814

)

(22,172

)

(14,116

)

(25,419

)

(37,528

)

(82,749

)

(213,798

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actual:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

28,737

 

15,723

 

 

18,338

 

18,242

 

58,986

 

140,026

 

Prior periods

 

3,543

 

310

 

17,624

 

4,490

 

25,805

 

18,994

 

70,766

 

Total

 

32,280

 

16,033

 

17,624

 

22,828

 

44,047

 

77,980

 

210,792

 

Balance at December 31, 2007

 

$

 (3,082

)

$

 (6,449

)

$

 (25,335

)

$

 (7,253

)

$

 (19,883

)

$

 (24,264

)

$

 (86,266

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(36,855

)

(13,899

)

(21,427

)

(21,176

)

(40,774

)

(122,517

)

(256,648

)

Prior periods

 

 

2

 

(27,732

)

108

 

(149

)

1,079

 

(26,692

)

Total

 

(36,855

)

(13,897

)

(49,159

)

(21,068

)

(40,923

)

(121,438

)

(283,340

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actual:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

32,418

 

5,911

 

 

15,079

 

19,233

 

73,874

 

146,515

 

Prior periods

 

3,082

 

6,447

 

38,071

 

7,144

 

19,543

 

23,187

 

97,474

 

Total

 

35,500

 

12,358

 

38,071

 

22,223

 

38,776

 

97,061

 

243,989

 

Balance at December 31, 2008

 

(4,437

)

(7,988

)

(36,423

)

(6,098

)

(22,030

)

(48,641

)

(125,617

)

 


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

 

Inventories— Effective October 1, 2008, we changed our method of accounting for inventories previously valued using the last-in, first-out (LIFO) method to the first-in, first-out (FIFO) method and adjusted our results for all of the periods presented.  As a result of this change, all inventories are now valued using the FIFO method.  Our inventories include the cost of raw materials, labor, overhead and shipping and handling costs.

 

The majority of our inventories are subject to expiration dating. We regularly evaluate the carrying value of our inventories and when, in our opinion, factors indicate that impairment has occurred, we establish a reserve against the inventories’ carrying value. Our determination that a valuation reserve might be required, in addition to the quantification of such reserve, requires us to utilize significant judgment. We base our analysis, in part, on the level of inventories on hand in relation to our estimated forecast of product demand, production requirements for forecasted product demand and the expiration dates of inventories. Although we make every effort to ensure the accuracy of forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying value of our inventories and our reported operating results. To date, inventory adjustments have not been material.

 

We expense pre-approval inventory unless we believe it is probable that the inventory will be saleable.  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.  With respect to capitalization of unapproved product candidates, we seek to produce inventory in preparation for the launch of the product and in amounts sufficient to support forecasted initial market demand. Typically, capitalization of this inventory does not begin until the product candidate is considered to have a high probability of regulatory approval. This may occur when either the product candidate is in Phase III clinical trials or when it is a new formulation or dosage strength of a presently approved product for which we believe there is a high probability of receiving FDA approval.  If we are aware of any specific risks or contingencies that are likely to impact the expected regulatory approval process or if there are any specific issues identified during the research process relating to safety, efficacy, manufacturing, marketing or labeling of the product candidate, we would not capitalize the related inventory.

 

When manufacturing and capitalizing inventory costs of product candidates and at each subsequent balance sheet date, we consider both the expiration dates of the inventory and anticipated future sales once approved.  Since expiration dates are

 



 

impacted by the stage of completion, we seek to avoid product expiration issues by managing the levels of inventory at each stage to optimize the shelf life of the inventory relative to anticipated market demand following launch.

 

Once we have determined to capitalize inventory for a product candidate that is not yet approved, we will monitor, on a quarterly basis, the status of this candidate within the regulatory approval process.  We could be required to expense previously capitalized costs related to pre-approval inventory upon a change in our judgment of future commercial use and net realizable value, due to a denial or delay of approval by regulatory bodies, a delay in the timeline for commercialization or other potential factors.

 

On a quarterly basis, we evaluate all inventory, including inventory capitalized for which regulatory approval has not yet been obtained, to determine if any lower of cost or market adjustment is required.  As it relates to pre-approval inventory, we consider several factors including expected timing of FDA approval, projected sales volume and estimated selling price.  Projected sales volume is based on several factors including market research, sales of similar products and competition in the market.  Estimated sales price is based on the price of existing products sold for the same indications and expected market demand.

 

In June 2007, we secured final FDA approval of NUVIGIL.  We intend to launch NUVIGIL commercially in the third quarter of 2009 and have included net NUVIGIL inventory balances of $111.6 million and $104.7 million at December 31, 2008 and 2007, respectively, in other assets, rather than inventory.  Upon launch, our NUVIGIL inventory balance will be reclassified to current inventory. Based on the expiration dates and our current estimates of sales demand for NUVIGIL, no additional reserve related to NUVIGIL is required at this time.  At December 31, 2006, we had an $8.6 million inventory reserve related to the FDA’s determination that the SPARLON sNDA was not approvable (see Note 7 of the Consolidated Financial Statements).

 

We have committed to make future minimum payments to third parties for certain raw material inventories. 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 third quarter 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 $57.8 million as of December 31, 2008.  Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  See Note 7 to our Consolidated Financial Statements for additional information.

 

Valuation of Property and Equipment, Intangible Assets and Goodwill—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 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.

 

For example, with respect to our DURASOLV intangible assets, 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 filed notices of appeal of the PTO’s decisions in the fourth quarter of 2007 regarding one patent and in the second quarter of 2008 regarding the second patent.  While we intend to vigorously defend these patents, these efforts, ultimately, may not be successful.  The invalidity of the DURASOLV patents could have a material adverse impact on the $48.7 million carrying value of the DURASOLV intangible assets. 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.

 

Income taxes— We provide for income taxes in accordance with SFAS No. 109, “Accounting for Income Taxes,” which requires that income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are

 



 

recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.  The deferred assets and liabilities included within the consolidated results from the activities of the variable interest entity are not realizable benefits and or liabilities to Cephalon. See Note 2 to our Consolidated Financial Statements for additional information.

 

We provide for income taxes at a rate equal to our estimated annual combined federal, state and foreign statutory effective rates. Subsequent adjustments to our estimates of our ability to recover the deferred tax assets or other changes in circumstances or estimates could cause our provision for income taxes to vary from period to period, as it has for the current year ended December 31, 2008.

 

At December 31, 2008, we have a valuation allowance of $140.4 million, against a gross deferred tax asset balance of $561.5 million.  This valuation allowance is composed entirely of state and foreign net operating losses, and state tax credits where we have concluded at this time that it is not more likely than not that these deferred tax assets will be realized. We will continue to review and analyze the likelihood of realizing tax benefits related to deferred tax assets as there is more certainty surrounding our future levels of profitability related to specific company operations and the related taxing jurisdictions.  See Note 16 of our Consolidated Financial Statements.

 

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes — an interpretation of FASB Statement No. 109” (“FIN 48”) which addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements.  Under FIN 48, a company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement.  FIN 48 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. FIN 48 is effective for fiscal years beginning after December 15, 2006.  We adopted the provisions of FIN 48 on January 1, 2007. See Note 16 of our Consolidated Financial Statements.

 

The recognition and measurement of certain tax benefits includes estimates and judgments by management and inherently includes subjectivity.  Changes in estimates may create volatility in our effective tax rate in future periods due to settlements with various tax authorities (either favorable or unfavorable), the expiration of the statute of limitations on some tax positions and obtaining new information about particular tax positions that may cause management to change its estimates.

 

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.

 

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.

 

We have no material assets or liabilities that are currently subject to recurring valuation under FAS 157.

 



 

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.  Our current accounting policies are consistent with the accounting under EITF 07-1. Therefore, the accounting for our collaborations have not changed.

 

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 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.

 

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 June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument (or embedded feature) is Indexed to an Entity’s Own Stock” (“EITF 07-5”).  EITF 07-5 provided guidance for determining whether an equity-linked financial instrument (or embedded feature) is indexed to an entity’s own stock.  This determination is necessary for evaluating whether the instrument (or feature) is considered a derivative financial instrument under SFAS No. 133.  The guidance is effective for fiscal years beginning on or after December 15, 2008.  We do not expect the adoption of EITF 07-5 to have a significant impact on our consolidated financial statements.

 

In September 2008, the FASB ratified EITF Issue No. 08-7, “Accounting for Defensive Intangible Assets” (“EITF 08-7”).  EITF 08-7 applies to all acquired intangible assets in situations in which the acquirer does not intend to actively use the asset but intends to hold (lock up) the asset to prevent its competitors from obtaining access to the asset (a defensive intangible asset), unless the intangible asset must be expensed in accordance with other literature.  The defensive intangible asset should be accounted for as a separate unit of accounting and its useful life should be determined by estimating the period over which the defensive intangible asset will diminish in fair value.  EITF 08-7 is effective prospectively for intangible assets acquired on or after the beginning of the first annual reporting period beginning on or after December 15, 2008.  We do not expect the adoption of EITF 08-7 to have a significant impact on our consolidated financial statements unless a future transaction results in the acquisition of a defensive intangible asset.

 


EX-99.3 5 a09-13592_2ex99d3.htm EX-99.3

Exhibit 99.3

 

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Report of Management

2

Report of Independent Registered Public Accounting Firm

3

 

 

Consolidated Financial Statements of Cephalon, Inc:

 

 

 

Consolidated Statements of Operations for each of the three years ended December 31, 2008

4

Consolidated Balance Sheets at December 31, 2008 and December 31, 2007

5

Consolidated Statements of Changes in Equity for each of the three years ended December 31, 2008

6

Consolidated Statements of Comprehensive Income/(Loss) for each of the three years ended December 31, 2008

7

Consolidated Statements of Cash Flows for each of the three years ended December 31, 2008

8

Notes to Consolidated Financial Statements

9

 



 

REPORT OF MANAGEMENT

 

Management’s Report on Financial Statements

 

Our management is responsible for the preparation, integrity and fair presentation of information in our consolidated financial statements, including estimates and judgments. The consolidated financial statements presented in this Current Report on Form 8-K have been prepared in accordance with accounting principles generally accepted in the United States of America. Our management believes the consolidated financial statements and other financial information included in this Current Report on Form 8-K fairly present, in all material respects, our financial condition, results of operations and cash flows as of and for the periods presented in this Current Report on Form 8-K. The consolidated financial statements have been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which is included herein.

 

Management’s Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined under Rule 13a-15(f) promulgated under the Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.

 

Our internal control over financial reporting includes those policies and procedures that:

 

·                  pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;

 

·                  provide reasonable assurance that our transactions are recorded as necessary to permit preparation of our financial statements in accordance with accounting principles generally accepted in the United States of America, and that our receipts and expenditures are being made only in accordance with authorization of our management and our directors; and

 

·                  provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the consolidated financial statements.

 

Because of its inherent limitations, internal control over financial reporting can provide only reasonable assurance and may not prevent or detect misstatements. Also, projections of any evaluation of the effectiveness of such controls in future periods are subject to the risk that the controls may become inadequate because of changes in conditions or that the degree of compliance with the policies and procedures may deteriorate.

 

Management conducted an assessment of the Company’s internal Control over financial reporting as of December 31, 2008 using the framework specified in Internal Control — Integrated Framework, published by the Committee of Sponsoring Organizations of the Treadway Commission.  Based on such assessment, management has concluded that the Company’s internal control over financial reporting was effective as of December 31, 2008.

 

The effectiveness of our internal control over financial reporting has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.

 



 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of Cephalon, Inc.:

 

In our opinion, the consolidated financial statements listed in the accompanying index present fairly, in all material respects, the financial position of Cephalon, Inc. and its subsidiaries at December 31, 2008 and 2007, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2008 in conformity with accounting principles generally accepted in the United States of America.  In addition, in our opinion, the financial statement schedule listed in the accompanying index, presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements.  Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).  The Company's management is responsible for these financial statements and financial statement schedule, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in "Management's Report on Internal Control Over Financial Reporting" appearing under Item 8.  Our responsibility is to express opinions on these financial statements, on the financial statement schedule, and on the Company's internal control over financial reporting based on our integrated audits.  We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects.  Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation.  Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.  Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

 

As discussed in the notes to the consolidated financial statements, the Company changed the manner in which it accounts for non-controlling interests as of January 1, 2009 (Note 1), convertible debt instruments as of January 1, 2009 (Note 1), uncertain tax positions as of January 1, 2007 (Note 16) and the value of certain inventory as of October 1, 2008 (Note 1).

 

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.  A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.  Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

/s/ PricewaterhouseCoopers LLP

Philadelphia, Pennsylvania

 

February 23, 2009, except with respect to our opinion on the consolidated financial statements insofar as it relates to the effects of the change in accounting for non-controlling interests (Note 1) and convertible debt instruments (Note 1), as to which the date is May 20, 2009

 



 

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

 

 

 

Year Ended December 31,

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

REVENUES:

 

 

 

 

 

 

 

Sales

 

$

1,943,464

 

$

1,727,299

 

$

1,720,172

 

Other revenues

 

31,090

 

45,339

 

43,897

 

 

 

1,974,554

 

1,772,638

 

1,764,069

 

 

 

 

 

 

 

 

 

COSTS AND EXPENSES:

 

 

 

 

 

 

 

Cost of sales

 

412,234

 

345,691

 

336,110

 

Research and development

 

362,208

 

369,115

 

424,239

 

Selling, general and administrative

 

840,873

 

735,799

 

689,492

 

Settlement reserve

 

7,450

 

425,000

 

 

Impairment charges

 

99,719

 

 

12,417

 

Restructuring charges

 

8,415

 

 

 

Acquired in-process research and development

 

41,955

 

 

5,000

 

Loss on sale of equipment

 

17,178

 

1,022

 

 

 

 

1,790,032

 

1,876,627

 

1,467,258

 

 

 

 

 

 

 

 

 

INCOME (LOSS) FROM OPERATIONS

 

184,522

 

(103,989

)

296,811

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

 

 

 

 

Interest income

 

16,901

 

32,816

 

25,438

 

Interest expense

 

(75,233

)

(70,866

)

(87,805

)

Debt exchange expense

 

 

 

(41,106

)

Gain on extinguishment of debt

 

 

5,319

 

 

Gain on sale of investment

 

 

5,791

 

 

Other income (expense), net

 

7,880

 

7,653

 

(1,172

)

 

 

(50,452

)

(19,287

)

(104,645

)

 

 

 

 

 

 

 

 

INCOME (LOSS) BEFORE INCOME TAXES

 

134,070

 

(123,276

)

192,166

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE (BENEFIT)

 

(37,819

)

103,153

 

76,524

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS)

 

171,889

 

(226,429

)

115,642

 

 

 

 

 

 

 

 

 

NET LOSS ATTRIBUTABLE TO NONCONTROLLING INTEREST

 

21,073

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS) ATTRIBUTABLE TO CEPHALON, INC

 

$

192,962

 

$

(226,429

)

$

115,642

 

 

 

 

 

 

 

 

 

BASIC INCOME (LOSS) PER COMMON SHARE ATTRIBUTABLE TO CEPHALON, INC

 

$

2.84

 

$

(3.40

)

$

1.91

 

 

 

 

 

 

 

 

 

DILUTED INCOME (LOSS) PER COMMON SHARE ATTRIBUTABLE TO CEPHALON, INC

 

$

2.54

 

$

(3.40

)

$

1.66

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

68,018

 

66,597

 

60,507

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION

 

76,097

 

66,597

 

69,672

 

 


(1)

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.” See Note 1 of the Consolidated Financial Statements for additional information.

(3)

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

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

 



 

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

 

 

 

December 31,

 

 

 

As adjusted
2008(1), (2)

 

As adjusted
2007(1),(2), (3)

 

ASSETS

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

524,459

 

$

818,669

 

Investments

 

 

7,596

 

Receivables, net

 

409,580

 

276,776

 

Inventory, net

 

117,297

 

98,996

 

Deferred tax assets, net

 

224,066

 

182,268

 

Other current assets

 

54,120

 

43,267

 

Total current assets

 

1,329,522

 

1,427,572

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, net

 

467,449

 

500,396

 

GOODWILL

 

445,332

 

476,515

 

INTANGIBLE ASSETS, net

 

607,332

 

817,828

 

DEFERRED TAX ASSETS, net

 

46,074

 

27,897

 

OTHER ASSETS

 

187,233

 

145,551

 

 

 

$

 3,082,942

 

$

3,395,759

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Current portion of long-term debt, net

 

$

781,618

 

$

944,659

 

Accounts payable

 

87,079

 

91,437

 

Accrued expenses

 

304,415

 

677,184

 

Total current liabilities

 

1,173,112

 

1,713,280

 

 

 

 

 

 

 

LONG-TERM DEBT

 

3,692

 

3,788

 

DEFERRED TAX LIABILITIES, net

 

77,932

 

56,540

 

OTHER LIABILITIES

 

163,123

 

138,084

 

Total liabilities

 

1,417,859

 

1,911,692

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

REDEEMABLE EQUITY

 

248,403

 

292,510

 

 

 

 

 

 

 

EQUITY:

 

 

 

 

 

Cephalon 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, 71,707,041 and 69,956,790 shares issued, and 68,736,642 and 67,604,187 shares outstanding

 

717

 

700

 

Additional paid-in capital

 

2,095,324

 

1,914,575

 

Treasury stock, at cost, 2,970,399 and 2,352,603 shares

 

(201,705

)

(158,173

)

Accumulated deficit

 

(521,286

)

(714,248

)

Accumulated other comprehensive income

 

43,630

 

148,703

 

Total Cephalon stockholders’ equity

 

1,416,680

 

1,191,557

 

Noncontrolling interest

 

 

 

Total equity

 

1,416,680

 

1,191,557

 

 

 

$

 3,082,942

 

$

3,395,759

 

 


(1)

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.” See Note 1 of the Consolidated Financial Statements for additional information.

(3)

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

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

 



 

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(In thousands, except share data)

 

 

 

 

 

 

 

Cephalon Stockholders’ Equity

 

 

 

 

 

 

 

Comprehensive

 

Common Stock

 

Additional
Paid-in

 

Treasury Stock

 

Accumulated

 

Accumulated Other
Comprehensive

 

Noncontrolling

 

 

 

Total

 

Income (Loss)

 

Shares

 

Amount

 

Capital

 

Shares

 

Amount

 

Deficit

 

Income

 

Interest

 

BALANCE, JANUARY 1, 2006, as previously stated

 

$

612,171

 

 

 

58,445,405

 

$

584

 

$

1,166,166

 

372,843

 

$

(17,125

)

$

(570,072

)

$

32,618

 

$

 

Impact of adopting change in accounting for Inventory

 

(9,015

)

 

 

 

 

 

 

 

 

 

 

 

 

(9,015

)

 

 

 

 

Adjustment for Adopting FASB Staff Position APB 14-1

 

(26,131

)

 

 

 

 

(8,925

)

 

 

(17,206

)

 

 

Balance, January 1, 2006, as adjusted1,2,3

 

$

577,025

 

 

 

58,445,405

 

$

584

 

$

1,157,241

 

372,843

 

$

(17,215

)

$

(596,293

)

$

32,618

 

$

 

Net income

 

115,642

 

$

115,642

 

 

 

 

 

 

 

 

 

 

 

115,642

 

 

 

 

 

Foreign currency translation gain

 

 

 

70,743

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized investment gains and losses

 

 

 

996

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income

 

71,739

 

71,739

 

 

 

 

 

 

 

 

 

 

 

 

 

71,739

 

 

Comprehensive income

 

 

 

$

187,381

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon conversions and exchanges of convertible notes

 

310,155

 

 

 

6,169,429

 

62

 

310,093

 

 

 

 

 

 

 

 

 

 

 

Termination of warrants and convertible note hedge upon exchanges of convertible notes

 

 

 

 

 

 

 

 

129,525

 

1,823,847

 

(129,525

)

 

 

 

 

 

 

Tax effect of conversions and exchanges of convertible notes

 

(5,186

)

 

 

 

 

 

 

(5,186

)

 

 

 

 

 

 

 

 

 

 

Stock options exercised

 

143,491

 

 

 

3,058,430

 

30

 

143,461

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from equity compensation

 

27,189

 

 

 

 

 

 

 

27,189

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

42,807

 

 

 

180,125

 

2

 

42,805

 

 

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

(4,418

)

 

 

 

 

 

 

 

 

60,472

 

(4,418

)

 

 

 

 

 

 

Reclassification from debt discount to redeemable equity

 

(93,098

)

 

 

 

 

 

 

(93,098

)

 

 

 

 

 

 

 

 

 

 

Gain on conversion and exchange of convertible notes

 

(25,668

)

 

 

 

 

 

 

(25,668

)

 

 

 

 

 

 

 

 

 

 

Amortization of debt discount under APB 14-1

 

44,269

 

 

 

 

 

 

 

44,269

 

 

 

 

 

 

 

 

 

 

 

BALANCE, DECEMBER 31, 20061,2,3

 

$

1,203,947

 

 

 

67,853,389

 

$

678

 

$

1,730,631

 

2,257,162

 

$

(151,068

)

$

(480,651

)

$

104,357

 

$

 

Net loss

 

(226,429

)

$

(226,429

)

 

 

 

 

 

 

 

 

 

 

(226,429

)

 

 

 

 

Foreign currency translation gain

 

 

 

42,662

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prior service gains and losses on retirement-related plans

 

 

 

446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized investment gains and losses

 

 

 

20

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income

 

43,128

 

43,128

 

 

 

 

 

 

 

 

 

 

 

 

 

43,128

 

 

 

Comprehensive loss

 

 

 

$

(183,301

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adoption of FIN 48

 

(7,168

)

 

 

 

 

 

 

 

 

 

 

 

 

(7,168

)

 

 

 

 

Issuance of common stock upon conversions and exchanges of convertible notes

 

10

 

 

 

124

 

 

10

 

 

 

 

 

 

 

 

 

 

 

Stock options exercised

 

93,900

 

 

 

1,853,152

 

19

 

93,881

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from equity compensation

 

13,633

 

 

 

 

 

 

 

13,633

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

46,695

 

 

 

250,125

 

3

 

46,692

 

 

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

(7,105

)

 

 

 

 

 

 

 

 

95,441

 

(7,105

)

 

 

 

 

 

 

Reclassification from debt discount to redeemable equity

 

(18,097

)

 

 

 

 

 

 

(18,097

)

 

 

 

 

 

 

 

 

 

 

Amortization of debt discount under APB 14-1

 

47,825

 

 

 

 

 

 

 

47,825

 

 

 

 

 

 

 

 

 

 

 

Other

 

1,218

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,218

 

 

 

BALANCE, DECEMBER 31, 20071,2,3

 

$

1,191,557

 

 

 

69,956,790

 

$

700

 

$

1,914,575

 

2,352,603

 

$

(158,173

)

$

(714,248

)

$

148,703

 

$

 

Net income

 

171,889

 

$

171,889

 

 

 

 

 

 

 

 

 

 

 

192,962

 

 

 

(21,073

)

Foreign currency translation loss

 

 

 

(105,042

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prior service costs and gains on retirement-related plans

 

 

 

(23

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized investment losses

 

 

 

(8

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

(105,073

)

(105,073

)

 

 

 

 

 

 

 

 

 

 

 

 

(105,073

)

 

 

Comprehensive income

 

 

 

$

66,816

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon conversions of convertible notes

 

290

 

 

 

529,269

 

5

 

285

 

 

 

 

 

 

 

 

 

 

 

Exercise of convertible note hedge associated with conversion of convertible notes

 

 

 

 

 

 

 

 

36,585

 

524,754

 

(36,585

)

 

 

 

 

 

 

Stock options exercised

 

43,962

 

 

 

957,865

 

10

 

43,952

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from equity compensation

 

7,323

 

 

 

 

 

 

 

7,323

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

43,974

 

 

 

253,837

 

2

 

43,972

 

 

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

(6,947

)

 

 

 

 

 

 

 

 

93,042

 

(6,947

)

 

 

 

 

 

 

Amortization of debt discount under APB 14-1

 

44,107

 

 

 

 

 

 

 

44,107

 

 

 

 

 

 

 

 

 

 

 

Acusphere NCI upon consolidation

 

21,073

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,073

 

Other

 

4,525

 

 

 

9,280

 

 

 

4,525

 

 

 

 

 

 

 

 

 

 

 

BALANCE, DECEMBER 31, 2008

 

$

1,416,680

 

 

 

71,707,041

 

$

717

 

$

2,095,324

 

2,970,399

 

$

(201,705

)

$

(521,286

)

$

43,630

 

$

 

 


(1)          As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)          As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”  See Note 1 of the Consolidated Financial Statements for additional information.

(3)          As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 of the Consolidated Financial Statements for additional information.

 

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

 



 

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME/(LOSS)

(In thousands)

 

 

 

Year Ended December 31,

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

 

 

 

 

 

 

 

 

Net Income/(loss)

 

$

171,889

 

$

(226,429

)

115,642

 

Other comprehensive income/(loss), net of tax:

 

 

 

 

 

 

 

Foreign Currency Translation Gains and Losses

 

$

(105,042

)

$

42,662

 

$

70,743

 

Prior service gains and losses on retirement-related plans

 

$

(23

)

$

446

 

$

 

 

Change in unrealized investment gains and losses

 

$

(8

)

$

20

 

$

996

 

Total other comprehensive income, net of tax

 

$

(105,073

)

$

43,128

 

$

71,739

 

 

 

 

 

 

 

 

 

Comprehensive Income/(loss), net of tax

 

$

66,816

 

$

(183,301

)

$

187,381

 

 

 

 

 

 

 

 

 

Comprehensive loss attributable to the noncontrolling interest

 

$

(21,073

)

0

 

0

 

 

 

 

 

 

 

 

 

Comprehensive income/(loss) attributable to Cephalon, Inc.

 

$

87,889

 

$

(183,301

)

$

187,381

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.” See Note 1 of the Consolidated Financial Statements for additional information.

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

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

 



 

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

 

Year Ended December 31,

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

Net income (loss)

 

$

171,889

 

$

(226,429

)

$

115,642

 

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

 

 

 

 

 

 

 

Deferred income tax expense (benefit)

 

(68,043

)

(21,090

)

11,150

 

Shortfall tax benefits from stock-based compensation

 

(511

)

(360

)

 

Debt exchange expense

 

 

 

41,106

 

Depreciation and amortization

 

172,457

 

141,358

 

128,927

 

Stock-based compensation expense

 

43,975

 

46,695

 

42,807

 

Gain on forgiveness of debt

 

 

(5,319

)

 

Gain on sale of investment

 

 

(5,791

)

 

Loss on sale of property and equipment

 

17,178

 

1,022

 

 

Impairment charges

 

99,719

 

 

12,417

 

Acquired in-process research and development

 

16,955

 

 

 

Amortization of debt discount and debt issuance costs

 

46,740

 

51,033

 

68,883

 

Changes in operating assets and liabilities, net of effect from acquisitions:

 

 

 

 

 

 

 

Receivables

 

(144,975

)

(601

)

(63,932

)

Inventory

 

(37,397

)

(2,328

)

21,015

 

Other assets

 

11,792

 

(54,838

)

(8,082

)

Accounts payable and accrued expenses

 

(376,232

)

385,463

 

(18,375

)

Other liabilities

 

44,576

 

76,041

 

(31,641

)

Net cash provided by (used for) operating activities

 

(1,877

)

384,856

 

319,917

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

Purchases of property and equipment

 

(75,871

)

(96,867

)

(159,917

)

Proceeds from sale of property and equipment

 

16,000

 

 

 

Cash balance from consolidation of variable interest entity

 

1,654

 

 

 

Acquisition of intangible assets

 

(25,825

)

(107,246

)

(115,850

)

Investment in third party

 

(31,692

)

 

 

Proceeds from sale of investment in third party

 

 

12,291

 

 

Sales and maturities of available-for-sale investments

 

7,596

 

99,131

 

260,082

 

Purchases of available-for-sale investments

 

 

(80,255

)

(4,691

)

Net cash used for investing activities

 

(108,138

)

(172,946

)

(20,376

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

Proceeds from exercises of common stock options

 

43,962

 

93,900

 

143,491

 

Windfall tax benefits from stock-based compensation

 

7,834

 

13,993

 

27,189

 

Acquisition of treasury stock

 

(6,947

)

(7,105

)

(4,418

)

Payments on and retirements of long-term debt

 

(217,743

)

(3,853

)

(188,886

)

Net cash provided by (used for) financing activities

 

(172,894

)

96,935

 

(22,624

)

 

 

 

 

 

 

 

 

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

 

(11,301

)

13,312

 

14,535

 

 

 

 

 

 

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

(294,210

)

322,157

 

291,452

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR

 

818,669

 

496,512

 

205,060

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, END OF YEAR

 

$

524,459

 

$

818,669

 

$

496,512

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

Cash payments for interest, net of capitalized interest

 

$

29,419

 

$

17,814

 

$

20,272

 

Cash payments for income taxes

 

100,374

 

84,879

 

36,954

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

Capital lease additions

 

1,529

 

1,335

 

2,134

 

Acquisition of treasury stock associated with termination of convertible note hedge and warrant agreements

 

36,585

 

 

129,525

 

Exchange of convertible notes into common stock, net of debt exchange expense

 

824

 

10

 

262,033

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

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

 



 

CEPHALON, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share data)

 

1.  NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Business

 

Cephalon is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in three core therapeutic areas: central nervous system (“CNS”) disorders, pain and oncology. In addition to conducting an active research and development program, we market seven proprietary products in the United States and numerous products in various countries throughout Europe.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses, and related disclosure of assets and liabilities. Actual results may differ from those estimates.

 

Principles of Consolidation

 

The consolidated financial statements include the results of our operations and our wholly-owned subsidiaries and, when applicable, entities for which Cephalon has a controlling financial interest. All significant intercompany accounts and transactions have been eliminated.

 

For variable interest entities, we assess the terms of our interest in the entity to determine if we are the primary beneficiary as prescribed by FASB Interpretation 46R, “Consolidation of Variable Interest Entities, an Interpretation of Accounting Research Bulletin No. 51” (“FIN 46R”). Variable interests are the ownership, contractual, or other pecuniary interests in an entity that change with changes in the fair value of the entity’s net assets excluding variable interests.  The primary beneficiary of a variable interest entity is the party that absorbs a majority of the entity’s expected losses, receives a majority of its expected residual returns, or both, as a result of holding variable interests. Beginning in November, 2008, we consolidate Acusphere, Inc. as a variable interest entity.

 

We use the cost method to account for our investments in companies that we do not control and for which we do not have the ability to exercise significant influence over operating and financial policies. In accordance with the cost method, these investments are recorded at cost or fair value, as appropriate.

 

Change in Accounting Method – Inventory

 

Effective October 1, 2008, we changed our method of accounting for inventories previously valued using the last-in, first-out (LIFO) method to the first-in, first-out (FIFO) method and adjusted our results for all of the periods presented.  As a result of this change, all inventories are now valued using the FIFO method.  We believe that this change is preferable as the FIFO method provides uniformity across our operations with respect to the method for inventory accounting, and enhances comparability with peers.

 

Furthermore, this application of the FIFO method will be consistent with our accounting of inventories for U.S. income tax purposes.

 

The change in accounting method from LIFO to FIFO was completed in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 154, “Accounting Changes and Error Corrections.”  We applied the change in accounting principle by retrospectively adjusting prior years’ financial statements.

 

The effect of the change on the consolidated statements of operations for the years ended December 31, 2008, 2007 and 2006 is as follows:

 



 

2008 (in millions)

 

As
Computed
under LIFO

 

As
Reported
under FIFO

 

Effect of
Change

 

Cost of sales

 

$

419.1

 

$

412.2

 

$

(6.9

)

Income before income tax

 

127.2

 

134.1

 

6.9

 

Income tax benefit

 

40.4

 

37.8

 

(2.6

)

Net Income

 

167.6

 

171.9

 

4.3

 

Net income attributable to Cephalon, Inc.

 

$

188.7

 

$

193.0

 

$

4.3

 

Basic earnings per share attributable to Cephalon, Inc.

 

$

2.78

 

$

2.84

 

$

0.06

 

Diluted earnings per share attributable to Cephalon, Inc.

 

$

2.49

 

$

2.54

 

$

0.05

 

 

2007 (in millions)

 

As
originally
reported under
LIFO

 

As
Adjusted

 

Effect of
Change

 

Cost of sales

 

$

341.9

 

$

345.7

 

$

3.8

 

Loss before income tax

 

(119.5

)

(123.3

)

(3.8

)

Income tax expense

 

104.6

 

103.2

 

(1.4

)

Net Income

 

(224.0

)

(226.4

)

(2.4

)

Net loss attributable to Cephalon, Inc.

 

$

(224.0

)

$

(226.4

)

$

(2.4

)

Basic loss per share attributable to Cephalon, Inc.

 

$

(3.37

)

$

(3.40

)

$

(0.03

)

Diluted loss per share attributable to Cephalon, Inc.

 

$

(3.37

)

$

(3.40

)

$

(0.03

)

 

2006 (in millions)

 

As
originally
reported under
LIFO

 

As
Adjusted

 

Effect of
Change

 

Cost of sales

 

$

338.8

 

$

336.1

 

$

(2.7

)

Income before income tax

 

189.5

 

192.2

 

2.7

 

Income tax expense

 

75.5

 

76.5

 

1.0

 

Net Income

 

113.9

 

115.6

 

1.7

 

Net income attributable to Cephalon, Inc.

 

$

113.9

 

$

115.6

 

$

1.7

 

Basic earnings per share attributable to Cephalon, Inc.

 

$

1.88

 

$

1.91

 

$

0.03

 

Diluted earnings per share attributable to Cephalon, Inc.

 

$

1.64

 

$

1.66

 

$

0.02

 

 

The effect of the change on the consolidated balance sheets as of December 31, 2008 and 2007 is as follows:

 

2008 (in millions)

 

As
Computed
under LIFO

 

As
Reported
under FIFO

 

Effect of
Change

 

Assets:

 

 

 

 

 

 

 

Inventory, net

 

$

112.3

 

$

117.3

 

$

5.0

 

Deferred tax assets, net

 

43.0

 

46.1

 

3.1

 

Other assets

 

200.7

 

187.2

 

(13.5

)

Total assets

 

$

3,088.3

 

$

3,082.9

 

$

(5.4

)

Cephalon Stockholders’ equity:

 

 

 

 

 

 

 

Accumulated deficit

 

$

(515.9

)

$

(521.3

)

$

(5.4

)

 

2007 (in millions)

 

As
originally
reported under
LIFO

 

As
Adjusted

 

Effect of
Change

 

Assets:

 

 

 

 

 

 

 

Inventory, net

 

$

99.1

 

$

99.0

 

$

(0.1

)

Deferred tax assets, net

 

22.2

 

27.9

 

5.7

 

Other assets

 

160.9

 

145.6

 

(15.3

)

Total assets

 

$

3,405.5

 

$

3,395.8

 

$

(9.7

)

Cephalon Stockholders’ equity:

 

 

 

 

 

 

 

Accumulated deficit

 

$

(704.5

)

$

(714.2

)

$

(9.7

)

 



 

The effect of the change on consolidated statement of cash flows for the years ended December 31, 2008, 2007 and 2006 is as follows:

 

2008 (in millions)

 

As
Computed
under LIFO

 

As
Reported
under FIFO

 

Effect of
Change

 

Net income:

 

$

167.6

 

$

171.9

 

$

4.3

 

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

 

 

 

 

 

 

 

Deferred income tax expense (benefit)

 

(70.6

)

(68.0

)

2.6

 

Change in inventory

 

(32.3

)

(37.4

)

(5.1

)

Change in other assets

 

13.6

 

11.8

 

(1.8

)

 

2007 (in millions)

 

As
originally
reported under
LIFO

 

As
Adjusted

 

Effect of
Change

 

Net loss:

 

$

(224.0

)

$

(226.4

)

$

(2.4

)

Adjustments to reconcile net loss to net cash provided by operating activities

 

 

 

 

 

 

 

Deferred income tax expense (benefit)

 

(19.7

)

(21.1

)

(1.4

)

Change in inventory

 

(6.0

)

(2.3

)

3.7

 

Change in other assets

 

(54.9

)

(54.8

)

0.1

 

 

2006 (in millions)

 

As
originally
reported
under LIFO

 

As
Adjusted

 

Effect of
Change

 

Net income:

 

$

113.9

 

$

115.6

 

$

1.7

 

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

 

 

 

 

 

 

 

Deferred income tax expense (benefit)

 

10.2

 

11.2

 

1.0

 

Change in inventory

 

22.6

 

21.0

 

(1.6

)

Change in other assets

 

(7.0

)

(8.1

)

(1.1

)

 

Foreign Currency

 

In December 2008, we entered into a foreign exchange contract to protect against fluctuations in the Euro against the U.S. Dollar related to intercompany transactions and payments.  This contract will mature in February 2009.  The contract has not been designated as a hedging instrument and, accordingly, it has been recorded at fair value with changes in fair value recognized in earnings as a component of other expense.  The fair value of the derivative instrument was insignificant at December 31, 2008.

 

For most of our foreign operating entities with currencies other than the U.S. dollar, the local currency is the functional currency. In cases where our foreign entity primarily operates in an economic environment using a currency other than their local currency, the currency in which the entity conducts a majority of its operations is the functional currency. We translate asset and liability balances at exchange rates in effect at the end of the period and income and expense transactions at the average exchange rates in effect during the period. Resulting translation adjustments are reported as a separate component of accumulated other comprehensive income included in stockholders’ equity. Gains and losses from foreign currency transactions are included in the consolidated statements of operations.  The amount of foreign currency gains (losses) included in our consolidated statement of operations was $8.0 million, $7.7 million and ($0.8) million for the three years ended December 31, 2008, 2007 and 2006, respectively.

 

Statement of Financial Accounting Standards (“SFAS”) No. 95, “Statement of Cash Flows” requires that the effect of exchange rate changes on cash held in foreign currencies be reported as a separate item in the reconciliation of beginning and ending cash and cash equivalents. All other foreign currency cash flows are reported in the applicable line of the consolidated statement of cash flows using an approximation of the exchange rate in effect at the time of the cash flows.

 



 

Other Comprehensive Income

 

We follow SFAS No. 130, “Reporting Comprehensive Income.” This statement requires the classification of items of other comprehensive income by their nature and disclosure of the accumulated balance of other comprehensive income, separately within the equity section of the balance sheet. Comprehensive income is comprised of net earnings and other comprehensive income, which includes certain changes in equity that are excluded from net earnings.

 

At December 31, accumulated other comprehensive income, net of taxes, consisted of the following:

 

 

 

2008

 

2007

 

Foreign currency translation gains

 

$

41,989

 

$

147,031

 

Prior service gains and losses on retirement-related plans

 

1,641

 

1,664

 

Change in unrealized investment gains and losses

 

 

8

 

 

 

 

 

 

 

Other comprehensive income

 

$

43,630

 

$

148,703

 

 

Cash Equivalents and Investments

 

Cash equivalents include investments in liquid securities with original maturities of three months or less from the date of purchase. In accordance with SFAS No. 115, “Accounting for Certain Investments in Debt and Equity Securities,” we consider our investments to be “available-for-sale.” We classify these investments as short-term and carry them at fair market value. Unrealized gains and losses have been recorded as a separate component of accumulated other comprehensive income included in stockholders’ equity. All realized gains and losses on our available-for-sale securities are recognized in results of operations.

 

Major U.S. Customers and Concentration of Credit Risk

 

Our three most significant products are PROVIGIL® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] (including our generic version of ACTIQ (“generic OTFC”)).  These products comprised the following for the years ended December 31:

 

 

 

% of total consolidated
net sales

 

% of net sales in
U.S. market

 

 

 

2008

 

2007

 

2006

 

2008

 

2007

 

2006

 

PROVIGIL sales

 

51

%

49

%

43

%

94

%

94

%

94

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FENTORA sales

 

8

 

8

 

2

 

100

 

100

 

100

 

ACTIQ sales (including generic OTFC)

 

14

 

21

 

36

 

80

 

89

 

96

 

FENTORA and ACTIQ sales (including generic OTFC)

 

22

%

29

%

38

%

87

%

92

%

96

%

 

In the United States, we sell our products primarily to a limited number of pharmaceutical wholesalers without requiring collateral. We periodically assess the financial strength of these customers and establish allowances for anticipated losses, if necessary.

 

 

 

% of total trade
accounts receivable

 

% of total
consolidated
gross sales

 

 

 

 

 

Year Ended

 

 

 

At December 31,

 

December 31,

 

 

 

2008

 

2007

 

2006

 

2008

 

2007

 

2006

 

Major U.S. customers:

 

 

 

 

 

 

 

 

 

 

 

 

 

AmerisourceBergen Corporation

 

13

%

7

%

8

%

17

%

13

%

15

%

Cardinal Health, Inc.

 

18

 

17

 

17

 

28

 

28

 

30

 

McKesson Corporation

 

19

 

15

 

15

 

26

 

25

 

26

 

Total

 

50

%

39

%

40

%

71

%

66

%

71

%

 

Inventory

 

Effective October 1, 2008, we changed our method of accounting for inventories previously valued using the last-in, first-out (LIFO) method to the first-in, first-out (FIFO) method and adjusted our results for all of the periods presented.  As a result of this change, all inventories are now valued using the FIFO method.  See Note 7 herein.

 

We expense pre-approval inventory unless we believe it is probable that the inventory will be saleable.  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.  With respect to capitalization of unapproved product candidates, we seek to produce inventory in preparation for the launch of the product and in amounts sufficient to support forecasted initial market demand. Typically, capitalization of this inventory does not begin until the product candidate is considered to have a high probability of regulatory approval. This may occur when either the product candidate is in Phase III clinical trials or when it is a new formulation or dosage strength of a presently approved product for which we believe there is a high probability of receiving FDA approval.  If we are aware of any specific risks or contingencies that are likely to impact the expected regulatory approval process or if there are any specific issues identified during the research process relating to safety, efficacy, manufacturing, marketing or labeling of the product candidate, we would not capitalize the related inventory.

 



 

When manufacturing and capitalizing inventory costs of product candidates and at each subsequent balance sheet date, we consider both the expiration dates of the inventory and anticipated future sales once approved.  Since expiration dates are impacted by the stage of completion, we seek to avoid product expiration issues by managing the levels of inventory at each stage to optimize the shelf life of the inventory relative to anticipated market demand following launch.

 

Once we have determined to capitalize inventory for a product candidate that is not yet approved, we will monitor, on a quarterly basis, the status of this candidate within the regulatory approval process.  We could be required to expense previously capitalized costs related to pre-approval inventory upon a change in our judgment of future commercial use and net realizable value, due to a denial or delay of approval by regulatory bodies, a delay in the timeline for commercialization or other potential factors.

 

On a quarterly basis, we evaluate all inventory, including inventory capitalized for which regulatory approval has not yet been obtained, to determine if any lower of cost or market adjustment is required.  As it relates to pre-approval inventory, we consider several factors including expected timing of FDA approval, projected sales volume and estimated selling price.  Projected sales volume is based on several factors including market research, sales of similar products and competition in the market.  Estimated sales price is based on the price of existing products sold for the same indications and expected market demand. See Note 7 herein.

 

Property and Equipment

 

Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets, which range from three to 40 years. Property and equipment under capital leases and leasehold improvements are depreciated or amortized over the shorter of the lease term or the expected useful life of the assets. Expenditures for maintenance and repairs are charged to expense as incurred, while major renewals and betterments are capitalized. See Note 8 herein.

 

We capitalize interest in connection with the construction of plant and equipment.

 

Fair Value of Financial Instruments

 

The carrying values of cash, cash equivalents, short-term investments, accounts receivable, accounts payable and accrued expenses approximate the respective fair values. The market value of our 2.0% convertible senior subordinated notes was $1.4 billion as compared to a carrying value of $589.4 million and the market value of our 2010 zero coupon convertible subordinated notes was $273.7 million as compared to a carrying value of $182.1 million, at December 31, 2008 based on quoted market values. The majority of our other debt instruments that were outstanding as of December 31, 2008 do not have readily ascertainable market values; however, management believes that the carrying values approximate the respective fair values. See Note 12 herein.

 

Goodwill, Intangible Assets and Other Long-Lived Assets

 

Goodwill represents the excess of purchase price over net assets acquired. In accordance with SFAS No. 142, “Goodwill and Other Intangible Assets,” goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair-value-based test. We perform our annual test of impairment of goodwill as of July 1. In accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” we review amortizable assets for impairment on an annual basis or whenever changes in circumstances indicate the carrying value of the asset may not be recoverable. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value to the fair value of the assets, which is usually based on the present value of the expected future cash flows associated with the use of the asset. See Note 9 herein.

 

Revenue Recognition

 

In the United States, we sell our proprietary products to pharmaceutical wholesalers, the largest three of which account for 71% of our total consolidated gross sales for the year ended December 31, 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 correlate to the number of prescriptions written for our products as reported by IMS Health Incorporated. We believe that speculative buying of product, particularly in anticipation of possible price increases, has been the historic practice of many pharmaceutical wholesalers. In past years, we attempted to minimize these fluctuations both by providing, from time to time, discounts to our customers to stock normal amounts of inventory (which we had historically defined as approximately one month’s supply at our current sales level) and by canceling orders if we believe a particular customer is speculatively buying inventory in anticipation of possible price increases.

 



 

We have distribution service agreements that 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 December 31, 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. At December 31, 2008, we believe that inventory held at wholesalers and retailers of our generic OTFC product, launched in October 2006, is approximately five months supply at our current sales levels.

 

We recognize revenue from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable, and collectability is reasonably assured. Additionally, revenue arrangements with multiple deliverables are divided into separate units of accounting if the deliverables in the arrangement meet the following criteria: the delivered item has value to the customer on a standalone basis; there is objective and reliable evidence of the fair value of undelivered items; and delivery of any undelivered item is probable.

 

In the United States, we sell all commercial products F.O.B. destination. Transfer of ownership and risk of loss for the product pass to the customer at the point that the product is received by the customer. In Europe, product sales are recognized predominantly upon customer receipt of the product except in certain contractual arrangements where different terms may be specified. We record product sales net of estimated reserves for contractual allowances, discounts and returns. Contractual allowances result from sales under contracts with managed care organizations and government agencies.

 

Other revenue, which includes revenues from collaborative agreements, consists primarily of royalty payments, payments for research and development services, up-front fees and milestone payments.  If an arrangement requires the delivery or performance of multiple deliverables or elements under a bundled sale, we determine whether the individual elements represent “separate units of accounting” under the requirements of Emerging Issues Task Force Issue 00-21, “Multiple-Deliverable Revenue Arrangements” (“EITF 00-21”). If the separate elements meet the requirements listed in EITF 00-21, we recognize the revenue associated with each element separately and revenue is allocated among elements based on relative fair value. If the elements within a bundled sale are not considered separate units of accounting, the delivery of an individual element is considered not to have occurred if there are undelivered elements that are essential to the functionality. Unearned income is amortized by the straight-line method over the term of the contracts. Also, if contractual obligations related to customer acceptance exist, revenue is not recognized for a product or service unless these obligations are satisfied.  Non-refundable up-front fees are deferred and amortized to revenue over the related performance period. We estimate our performance period based on the specific terms of each collaborative agreement. We adjust the performance periods, if appropriate, based upon available facts and circumstances. We recognize periodic payments on a percentage of completion basis over the period that we perform the related activities under the terms of the agreements. Revenue resulting from the achievement of milestone events stipulated in the agreements is recognized when the milestone is achieved. Milestones are based upon the occurrence of a substantive element specified in the contract or as a measure of substantive progress towards completion under the contract.  In connection with these collaborations, we also incurred costs that are reflected in our operating expenses of $14.0 million for the year ended December 31, 2006. For the years ended December 31, 2008 and 2007, incurred costs that are reflected in our operating expenses were insignificant in connection with these collaborations.

 

Payments under co-promotional or managed services agreements are recognized when the products are sold or the promotional activities are performed. The portion of the payments that represents reimbursement of our expenses is recognized as an offset to those expenses in our statement of income.

 

We recognize revenue on new product launches when sales returns can be reasonably estimated and all other revenue recognition requirements have been met. When determining if returns can be estimated, we consider actual returns of similar products as well as sales returns with similar customers. In cases in which a new product is not an extension of an existing line of product or where we have no history of experience with products in a similar therapeutic category such that we can not estimate expected returns of the new product, we defer recognition of revenue until the right of return no longer exists or until we have developed sufficient historical experience to estimate sales returns. In developing estimates for sales returns, we consider inventory levels in the distribution channel, shelf life of the product and expected demand based on market data and prescriptions.

 

Sales of our generic OTFC product could be subject to retroactive price reductions for units that remain in the pipeline if the price of generic OTFC is reduced, including as a result of another generic entrant into the market, and as a result any estimated impact of such adjustments is recorded at the time revenue is recognized.  This estimate of both the potential timing of a generic entrant and the amount of the price reduction are highly subjective.  At December 31, 2008, we are not aware of any expected additional entrants into the generic OTFC market that would result in a price reduction to

 



 

customers for inventory already purchased from us, and do not believe that any revenue recognized as of December 31, 2008 would be effected by a retroactive shelf stock adjustment.

 

Research and Development

 

All research and development costs are charged to expense as incurred.

 

Acquired In-Process Research and Development

 

Acquired in-process research and development (“IPR&D”) represents the estimated fair value assigned to research and development projects acquired in a purchase business combination or from the initial consolidation of a variable interest entity that have not been completed at the date of acquisition and which have no future alternative use. Accordingly, these costs are charged to expense as of the acquisition date.

 

The value assigned to IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting net cash flows from the projects and discounting the net cash flows to their present value. The revenue projections used to value IPR&D were, in some cases, reduced based on the probability of developing a new drug, and considered the relevant market sizes and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by us and our competitors. The resulting net cash flows from such projects are based on management’s estimates of cost of sales, operating expenses and income taxes from such projects. The rates utilized to discount the net cash flows to their present value were based on estimated cost of capital calculations.

 

If these projects are not successfully developed, the sales and profitability of the combined company may be adversely affected in future periods. Additionally, the value of other acquired intangible assets may become impaired. We believed that the foregoing assumptions used in the IPR&D analysis were reasonable at the time of the acquisition. No assurance can be given, however, that the underlying assumptions used to estimate expected project sales, development costs or profitability or the events associated with such projects, will transpire as estimated.

 

Income Taxes

 

We provide for income taxes in accordance with SFAS No. 109, “Accounting for Income Taxes,” which requires that income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.  We provide for income taxes at a rate equal to our estimated annual combined federal, state and foreign statutory effective rates. Subsequent adjustments to our estimates of our ability to recover the deferred tax assets or other changes in circumstances or estimates could cause our provision for income taxes to vary from period to period, as it has for the current year ended December 31, 2008.

 

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes — an interpretation of FASB Statement No. 109” (“FIN 48”).  FIN 48 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under FIN 48, we may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement.  FIN 48 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. FIN 48 is effective for fiscal years beginning after December 15, 2006.  We adopted the provisions of FIN 48 on January 1, 2007. See Note 16 herein.

 

Change in Accounting Method - APB 14-1 and FAS 160

 

As discussed below, certain prior year amounts have been retrospectively adjusted to comply with Financial Accounting Standards Board (“FASB”)  Staff Position (“FSP”) Accounting Principles Board (“APB”) No. APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (“FSP APB 14-1”) and Statement of Financial Accounting Standard (“FAS”) No. 160, “Noncontrolling Interests



 

in Consolidated Financial Statements” (“FAS 160”). In addition, certain reclassifications of prior year amounts have been made to conform to the current year presentation, which have no impact on our total assets or liabilities.

 

As of January 1, 2009, we adopted the provisions of FAS 160.  As a result of adoption, we have reclassified noncontrolling interest from liabilities to a component of equity and we will attribute losses to the noncontrolling interest even if that attribution results in a deficit noncontrolling interest balance.  We adopted the presentations and disclosures of FAS 160 on a retrospective basis for all period presented.

 

As of January 1, 2009, we adopted the provisions of 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 liability and equity components of the convertible debt separately.  We adopted the provisions of FSP APB 14-1 on a retrospective basis for all prior periods presented.   In association with FSP APB 14-1 and in accordance with FASB Topic No. D-98, we have also presented a temporary equity classification, “redeemable equity,” to highlight cash obligations that are attached to an equity security in order to distinguish this value from permanent capital.

 

The liability component of our convertible notes will be classified as current liabilities and presented in current portion of long-term debt and the equity component of our convertible debt will be considered redeemable security and presented as redeemable equity 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 Convertible Subordinated Notes due June 2033, first putable June 15, 2010 (the “2010 Zero Coupon Notes”), respectively, at the balance sheet date.  At December 31, 2008, our stock price was $77.04 and, therefore, all of our convertible notes are considered to be current liabilities and are presented in current portion of long-term debt on our consolidated balance sheet.  At December 31, 2007, our stock price was $71.76, and, therefore, all of our convertible notes were considered to be current liabilities and are presented in current portion of long term debt on our consolidated balance sheet.

 

The effect of the change to the new standard of FSP ABP 14-1 on the consolidated statements of operations for the years ended December 31, 2008, 2007 and 2006 is as follows:

 

2008 (in millions)

 

As
reported
before
FSP APB 14-1

 

As
adjusted
under
FSP APB 14-1

 

Effect of
Change

 

Interest expense

 

$

28.5

 

$

75.2

 

$

(46.7

)

Income tax expense (benefit)

 

(20.7

)

(37.8

)

17.1

 

Net income attributable to Cephalon, Inc.

 

$

222.6

 

$

193.0

 

$

(29.6

)

Basic earnings per share attributable to Cephalon, Inc.

 

$

3.27

 

$

2.84

 

$

(0.43

)

Diluted earnings per share attributable to Cephalon, Inc.

 

$

2.92

 

$

2.54

 

$

(0.38

)

 

2007 (in millions)

 

As
reported
before
FSP APB 14-1

 

As
adjusted under
FSP APB 14-1

 

Effect of
Change

 

Interest expense

 

$

19.9

 

$

70.9

 

$

(51.0

)

Income tax expense (benefit)

 

121.9

 

103.2

 

18.7

 

Net income attributable to Cephalon, Inc.

 

$

(194.1

)

$

(226.4

)

$

(32.3

)

Basic earnings per share attributable to Cephalon, Inc.

 

$

(2.91

)

$

(3.40

)

$

(0.49

)

Diluted earnings per share attributable to Cephalon, Inc.

 

$

(2.91

)

$

(3.40

)

$

(0.49

)

 

2006 (in millions)

 

As
reported
before
FSP APB 14-1

 

As
adjusted under
FSP APB 14-1

 

Effect of
Change

 

Interest expense

 

$

18.9

 

$

87.8

 

$

(68.9

)

Debt exchange expense

 

$

48.1

 

$

41.1

 

$

7.0

 

Write-off of deferred issuance costs

 

$

13.1

 

$

 

$

13.1

 

Income tax expense (benefit)

 

94.4

 

76.5

 

17.9

 

Net income attributable to Cephalon, Inc.

 

$

146.5

 

$

115.6

 

$

(30.9

)

Basic earnings per share attributable to Cephalon, Inc.

 

$

2.42

 

$

1.91

 

$

(0.51

)

Diluted earnings per share attributable to Cephalon, Inc.

 

$

2.10

 

$

1.66

 

$

(0.44

)

 

The effect of the change to the new standard of FSP APB 14-1 on the consolidated balance sheets as of December 31, 2008 and 2007 is as follows:

 



 

2008 (in millions)

 

As
reported
before
FSP APB 14-1

 

As
adjusted
under
FSP APB 14-1

 

Effect of
Change

 

Assets:

 

 

 

 

 

 

 

Deferred tax assets

 

$

142.8

 

$

46.1

 

$

(96.7

)

Other assets (debt issuance costs)

 

176.7

 

187.2

 

10.5

 

Total assets

 

3,169.1

 

3,082.9

 

(86.2

)

Liabilities:

 

 

 

 

 

 

 

Current portion of long term debt, net

 

$

1,030.0

 

$

781.6

 

$

(248.4

)

Redeemable equity

 

$

 

$

248.4

 

$

248.4

 

Cephalon stockholders’ equity:

 

 

 

 

 

 

 

Additional paid-in capital

 

$

2,071.6

 

$

2,095.3

 

$

23.7

 

Accumulated deficit

 

(411.4

)

(521.3

)

(109.9

)

Total Cephalon stockholders’ equity

 

1,502.9

 

1,416.7

 

(86.2

)

Total liabilities and equity

 

$

3,169.1

 

$

3,082.9

 

$

(86.2

)

 

2007 (in millions)

 

As
originally
reported

 

As
adjusted under
FSP APB 14-1

 

Effect of
Change

 

Assets:

 

 

 

 

 

 

 

Deferred tax assets

 

$

141.8

 

$

27.9

 

$

(113.9

)

Other assets (debt issuance costs)

 

$

132.5

 

$

145.6

 

$

13.1

 

Total assets

 

3,496.6

 

3,395.8

 

(100.8

)

Liabilities:

 

 

 

 

 

 

 

Current portion of long term debt, net

 

$

1,237.2

 

$

944.7

 

$

(292.5

)

Redeemable equity

 

$

 

$

292.5

 

$

292.5

 

Cephalon stockholders’ equity:

 

 

 

 

 

 

 

Additional paid-in capital

 

$

1,935.0

 

$

1,914.6

 

$

(20.4

)

Accumulated deficit

 

(633.8

)

(714.2

)

(80.4

)

Total Cephalon stockholders’ equity

 

1,292.4

 

1,191.6

 

(100.8

)

Total liabilities and equity

 

$

3,496.6

 

$

3,395.8

 

$

(100.8

)

 

The effect of the change to the new standard of FSP APB 14-1 on consolidated statement of cash flows for the years ended December 31, 2008, 2007 and 2006 is as follows:

 

2008 (in millions)

 

As
computed
before
FSP APB 14-1

 

As
reported
under
FSP APB 14-1

 

Effect of
Change

 

Net income:

 

$

222.6

 

$

171.9

 

$

(50.7

)

Deferred income tax expense (benefit)

 

(50.9

)

(68.0

)

(17.1

)

Amortization of debt discount

 

 

46.7

 

46.7

 

Minority interest in VIE

 

(21.2

)

0

 

21.2

 

 

2007 (in millions)

 

As
originally
reported

 

As
adjusted under FSP APB 14-1

 

Effect of
Change

 

Net income (loss):

 

$

(194.1

)

$

(226.4

)

$

(32.3

)

Deferred income tax expense (benefit)

 

(2.4

)

(21.1

)

(18.7

)

Amortization of debt discount

 

 

51.0

 

51.0

 

 



 

2006 (in millions)

 

As
originally
reported
FSP APB 14-1

 

As
adjusted
under
FSP APB 14-1

 

Effect of
Change

 

Net income:

 

$

146.5

 

$

115.6

 

$

(30.9

)

Deferred income tax expense (benefit)

 

29.0

 

11.2

 

(17.8

)

Debt exchange expense

 

48.1

 

41.1

 

(7.0

)

Write-off of debt issuance costs

 

13.1

 

 

(13.1

)

Amortization of debt discount

 

 

68.9

 

68.9

 

 

The carrying amount of the equity component of convertible notes is $248.4 million and $292.5 million at December 31, 2008 and 2007, respectively.  The debt discount will be amortized over the next 6 and one-half years for the 2.0% Notes and the next year and one-half for the 2010 Zero Coupon Notes.  The if-converted values of our convertible notes at December 31, 2008 are $1,341.9 million and $272.0 million for our 2.0% Notes and our 2010 Zero Coupon Notes, respectively.  The effective interest rates on the liability components of our convertible notes are 7.54% and 6.42% for our 2.0% Notes and our 2010 Zero Coupon Notes, respectively.  We recognized $63.1 million, $67.4 million, and $87.2 million of interest cost related to our convertible notes for the years ended December 31, 2008, 2007 and 2006 respectively; the contractual interest coupon amount was $16.4 million for both 2008 and 2007 and $18.3 million for 2006.

 

Recent Accounting Pronouncements

 

In September 2006, the FASB issued 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.

 

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.

 

We have no material assets or liabilities that are currently subject to recurring valuation under FAS 157.

 

In November 2007, the 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.  Our current accounting policies are consistent with the accounting under EITF 07-1. Therefore, the accounting for our collaborations has not changed.

 

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 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.

 

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 June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument (or embedded feature) is Indexed to an Entity’s Own Stock” (“EITF 07-5”).  EITF 07-5 provided guidance for determining whether an equity-linked financial instrument (or embedded feature) is indexed to an entity’s own stock.  This determination is necessary for evaluating whether the instrument (or feature) is considered a derivative financial instrument under SFAS No. 133.  The guidance is effective for fiscal years beginning on or after December 15, 2008.  We do not expect the adoption of EITF 07-5 to have a significant impact on our consolidated financial statements.

 

In September 2008, the FASB ratified EITF Issue No. 08-7, “Accounting for Defensive Intangible Assets” (“EITF 08-7”).  EITF 08-7 applies to all acquired intangible assets in situations in which the acquirer does not intend to actively use the asset but intends to hold (lock up) the asset to prevent its competitors from obtaining access to the asset (a defensive intangible asset), unless the intangible asset must be expensed in  accordance with other literature.   The defensive intangible asset should be accounted for as a separate unit of accounting and its useful life should be determined by estimating the period over which the defensive intangible asset will diminish in fair value.  EITF 08-7 is effective prospectively for intangible assets acquired on or after the beginning of the first annual reporting period beginning on or after December 15, 2008.  We do not expect the adoption of EITF 08-7 to have a significant impact on our consolidated financial statements unless a future transaction results in the acquisition of a defensive intangible asset.

 

Collaborative Arrangements

 

As of January 1, 2009, we adopted the provisions for Emerging Issues Task Force (“EITF”) Abstract Issue No. 07-1, “Accounting for Collaborative Arrangements” (“EITF 07-1”), which resulted in the following additional disclosures for our collaborative arrangements. 

 

We enter into collaborative arrangements with pharmaceutical or biotech companies to develop and produce orally disintegrating tablets (“ODT’s”) of branded and generic drugs.  In these arrangements, we earn fees for the adaptation of the technologies and know-how to the active pharmaceutical ingredient, as well as license fees and milestones for access to the technology and successful achievement of mutually agreed objectives.  We also manufacture product under a supply agreement and / or license the ODT, earning a royalty on the collaborative partner’s net sales of the product.  Revenues recognized from product sales are classified as sales and revenues recognized from fees for development services, license fees, milestones and royalties are classified as other revenues. 

 

Amounts recognized under collaborative arrangements consisted of the following:

 

 

 

2008

 

2007

 

2006

 

Sales

 

$

34,676

 

$

37,963

 

$

40,199

 

Other Revenues

 

26,686

 

37,846

 

33,534

 

Total

 

$

61,362

 

$

75,809

 

$

73,733

 

 

2.  ACQUISITIONS AND TRANSACTIONS

 

AMRIX Acquisition

 

In August 2007, we acquired exclusive North American rights to AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) from E. Claiborne Robins Company, Inc., a privately-held company d/b/a ECR Pharmaceuticals (“ECR”).  We made an initial payment of $100.1 million cash to ECR upon the closing of the acquisition, $0.9 million and $99.2 million of which was capitalized as inventory and an intangible asset, respectively.  Under the acquisition agreement, ECR also could receive up to an additional $255 million in milestone payments that are contingent on attainment of certain agreed-upon sales levels of AMRIX.  Two dosage strengths of AMRIX (15 mg and 30 mg) were approved in February 2007 by the FDA for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm 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.

 

Co-Promotion Agreement with Takeda

 

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 are 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 were calculated based on a percentage of royalties to TPNA during the final twelve months of the agreement.  During 2008, we recorded an accrual of $28.2 million representing the present value of the Sunset Payments due to TPNA. Payment of this accrual will occur over the next three years.

 

Acusphere, Inc.

 

On November 3, 2008, we entered into a license and convertible note transaction with Acusphere, Inc., a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology.  In connection with the transaction, we received an exclusive worldwide license from Acusphere 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 $15 million 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 “Acusphere Note”) from Acusphere, secured by substantially all the assets of Acusphere (including Acusphere’s intellectual property).  The Acusphere 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 Acusphere 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. Separately, on March 28, 2008, we purchased license rights for Acusphere’s HDDS technology for use in oncology therapeutics for $10 million.

 

In accordance with FIN 46R, we have determined that effective on November 3, 2008 Acusphere is a variable interest entity for which we are the primary beneficiary.  As a result, as of November 3, 2008 we have included the financial condition and results of operations of Acusphere in our consolidated financial statements.  However, we do not have an equity interest in Acusphere and, therefore, we have allocated the losses attributable to the noncontrolling interest in Acusphere to noncontrolling interest in the consolidated statement of operations and we have also reduced the noncontrolling interest holders’ ownership interest in Acusphere in the consolidated balance sheet by Acusphere’s losses.  For the year ended December 31, 2008, both of these amounts have been limited to the value of the noncontrolling interest recorded as of November 3, 2008, but will not be limited starting January 1, 2009.

 

During 2008, as a result of the FDA Advisory Panel’s recommendation not to approve Imagify, we determined that the carrying value of Acusphere’s long-lived assets exceeded the expected cash flows from the use of its assets.  Accordingly, we reduced the property and equipment carrying values to their estimated fair value based on prices for similar assets and recognized a $9.3 million impairment charge. For the year ended December 31, 2008, a total of $21.1 million of net losses were allocated to the noncontrolling interest and $11.7 million of net losses exceeded the noncontrolling interest value.

 

The following summarizes the carrying amounts and classification of Acusphere’s assets and liabilities included in our consolidated statement of financial position as of December 31, 2008:

 

Cash and cash equivalents

 

$

16,450

 

Receivables, net

 

4

 

Other current assets

 

1,232

 

Property and equipment, net

 

5,379

 

Other assets

 

949

 

Current portion of long-term debt

 

7,127

 

Accounts payable

 

959

 

Accrued expenses

 

4,886

 

Long-term debt

 

1,769

 

Other liabilities

 

741

 

Accumulated deficit

 

(11,661

)

 

Although Acusphere is included in our consolidated financial statements, our interest in Acusphere’s assets are limited to those accorded to us in the agreements with Acusphere as described above.  Acusphere’s creditors have no recourse to the general credit of Cephalon.

 

LUPUZOR License

 

On November 25, 2008, we entered into an option agreement (the “Immupharma Option Agreement”) with ImmuPharma PLC providing us with an option to obtain an exclusive, worldwide license to the investigational medication LUPUZOR™ for the treatment of systemic lupus erythematosus.  Under the terms of the Immupharma Option Agreement, we paid ImmuPharma a $15 million upfront option payment upon execution, which was expensed as in-process research and development in the Consolidated Statement of Operations.   On January 30, 2009, we exercised the option and entered into a Development and Commercialization Agreement with Immupharma based on a review of interim results of a Phase IIb study for LUPUZOR.  See Note 19 for additional details.

 

Ception Therapeutics, Inc.

 

In November 2008, we paid a $25 million non-refundable fee to Ception for exclusive rights to negotiate an option to purchase Ception at any time through the completion of its Phase IIb/III clinical trial for reslizumab in pediatric patients with eosinophilic esophagitis. This charge has been recorded in other assets on our balance sheet.  In January 2009, we entered into the option agreement with Ception.  See Note 19 for additional details.

 



 

3.              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 was 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 $20 million.

 

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

 

Restructuring reserves as of January 1, 2008

 

$

 

Severance costs

 

6,877

 

Manufacturing and personnel transfer costs

 

1,538

 

Payments

 

(4,682

)

Restructuring reserves as December 31, 2008

 

$

3,733

 

 

4.              ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT EXPENSE

 

In 2008 we recognized acquired in-process research and development expense of (i) $10.0 million related to our purchased of license rights for Acusphere’s HDDS technology for use in oncology therapeutics, (ii) 15.0 million related to LUPUZOR, a compound in phase IIb testing for the treatment of systemic lupus erythematosus, not yet approved by the FDA and (iii) $17.0 million in connection with the initial consolidation of Acusphere, a variable interest entity for which we are the primary beneficiary.

 

In 2006, we recorded acquired in-process research and development expense of $5.0 million related to our armodafinil license and assignment agreement with TransForm Pharmaceuticals, Inc.

 



 

5.              CASH, CASH EQUIVALENTS AND INVESTMENTS

 

At December 31, cash, cash equivalents and investments consisted of the following:

 

 

 

2008

 

2007

 

Cash and cash equivalents:

 

 

 

 

 

Demand deposits

 

$

524,459

 

$

487,683

 

Repurchase agreements

 

 

330,986

 

Commercial paper

 

 

 

 

 

524,459

 

818,669

 

Short-term investments (at market value):

 

 

 

 

 

U.S. government agency obligations

 

 

 

Asset-backed securities

 

 

 

Bonds

 

 

1,599

 

Commercial paper

 

 

5,997

 

 

 

 

7,596

 

 

 

$

524,459

 

$

826,265

 

 

The contractual maturities of our investments in cash, cash equivalents, and investments at December 31, 2008 are all less than one year.

 

6.              RECEIVABLES, NET

 

At December 31, receivables, net consisted of the following:

 

 

 

2008

 

2007

 

Trade receivables

 

$

342,904

 

$

280,091

 

Receivables from collaborations

 

 

57

 

Other receivables

 

81,476

 

8,984

 

 

 

424,380

 

289,132

 

Less reserve for sales discounts and allowances

 

(14,800

)

(12,356

)

 

 

$

409,580

 

$

276,776

 

 

Trade receivables are recorded at the invoiced amount and do not bear interest. In 2008, other receivable includes income taxes receivable of $71.9 million. Our allowance for doubtful accounts is our best estimate of probable credit losses in our existing accounts receivable. We determine the allowance based on a percentage of trade receivables past due, specific customer issues, and a reserve related to our specific historical write-off experience and general industry experience. We review and adjust our allowance for doubtful accounts quarterly. Receivable balances or specific customer issues are written off against the allowance when we feel that it is probable that the receivable amount will not be recovered. Certain European receivable balances with government operated hospitals are over 90 days past due but we believe are collectible and are therefore, not reserved. In the past, our historical write-off experience has not been significant. We do not have any off-balance sheet credit exposure related to our customers.

 

7.              INVENTORY, NET

 

At December 31, inventory, net consisted of the following:

 

 

 

2008

 

As Adjusted
2007*

 

Raw materials

 

$

27,555

 

$

32,139

 

Work-in-process

 

35,501

 

23,743

 

Finished goods

 

54,241

 

43,114

 

Total inventory, net

 

$

117,297

 

$

98,996

 

 

 

 

 

 

 

Inventory, net included in other non-current assets

 

$

111,598

 

$

104,688

 

 


*As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 for additional information.

 



 

Inventory is stated at the lower of cost or market value.  Effective October 1, 2008, we changed our method of accounting for inventories previously valued using the last-in, first-out (LIFO) method to the first-in, first-out (FIFO) method and adjusted our results for all of the periods presented.  As a result of this change, all inventories are now valued using the FIFO method.

 

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 third quarter of 2009 and have included net NUVIGIL inventory balances of $111.6 million and $104.7 million at December 31, 2008 and December 31, 2007, respectively, in other non-current assets, rather than inventory.  Upon launch, our NUVIGIL inventory balance will be reclassified to current 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 third quarter 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 $57.8 million as of December 31, 2008.  Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.

 

In August 2006, we announced that we received a letter from the FDA stating that our supplemental new drug application (“sNDA”) for SPARLON™ (modafinil) Tablets [C-IV], a proprietary dosage form of modafinil for the treatment of attention-deficit/hyperactivity disorder in children and adolescents, was not approvable.  In light of the FDA’s decision, we currently are not pursuing development of SPARLON. Prior to the FDA’s decision that the sNDA for SPARLON was not approvable, we had net capitalized inventory costs related to SPARLON of $8.6 million. In consideration of the FDA’s decision, we have fully reserved all of these capitalized inventory costs related to SPARLON at December 31, 2006.

 

8.  PROPERTY AND EQUIPMENT, NET

 

At December 31, property and equipment, net consisted of the following:

 

 

 

Estimated
Useful Lives

 

2008

 

2007

 

Land and improvements

 

 

$

8,783

 

$

9,094

 

Buildings and improvements

 

3-40 years

 

316,740

 

277,666

 

Laboratory, machinery and other equipment

 

3-30 years

 

347,433

 

262,749

 

Construction in progress

 

 

51,223

 

98,157

 

 

 

 

 

724,179

 

647,666

 

Less accumulated depreciation and amortization

 

 

 

(256,730

)

(147,270

)

 

 

 

 

$

 467,449

 

$

500,396

 

 

Depreciation and amortization expense related to property and equipment, excluding depreciation related to assets used in the production of inventory, was $54.3 million, $33.3 million and $34.8 million for the years ended December 31, 2008, 2007 and 2006, respectively. We had $50.5 million and $50.0 million of capitalized computer software costs included in property and equipment, net, at December 31, 2008 and 2007, respectively.  Depreciation and amortization expense related to capitalized software costs was $15.6 million, $11.0 million and $11.2 million for the years ended December 31, 2008, 2007 and 2006, respectively. We had $9.0 million and $28.8 million of capitalized software costs included in construction in progress at December 31, 2008 and 2007, respectively.

 

During 2008, as a result of the FDA Advisory Panel’s recommendation not to approve Imagify, we determined that the carrying value of Acusphere’s long-lived assets exceeded the expected cash flows from the use of its assets.  Accordingly, we reduced the property and equipment carrying values to their estimated fair value based on prices for similar assets and recognized a $9.3 million impairment charge.

 



 

On November 26, 2008, we incurred a $17.2 million loss on sale of the product manufacturing equipment and other capital improvements relating to our termination agreement with Alkermes, Inc. related to VIVITROL. See Note 10 for additional details.

 

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 year we have recorded pre-tax, non-cash charges associated with accelerated depreciation of plant and equipment of $6.0 million related to the proposed divestiture based on the new estimated useful life.  As of December 31, 2008, we had $34.8 million of net property and equipment related to the Mitry-Mory facility included on our balance sheet.

 

9.  GOODWILL

 

Goodwill consisted of the following:

 

 

 

United 
States

 

Europe

 

Total

 

December 31, 2007

 

$

266,393

 

$

210,122

 

$

476,515

 

Release of pre-acquisition tax reserves and valuation allowance

 

(4,593

)

3,754

 

(839

)

Foreign currency translation adjustment

 

 

(30,344

)

(30,344

)

Other

 

82,510

 

(82,510

)

 

December 31, 2008

 

$

344,310

 

$

101,022

 

$

445,332

 

 

We completed our annual test of impairment of goodwill as of July 1, 2008 and concluded that goodwill was not impaired. During 2008, we revised our segment reporting to reflect our current operating structure.  The goodwill allocation between segments above has also been reallocated based on changes to the way we view our reporting units, which has also been impacted by the decision surrounding the Mitry-Mory facility.

 

10.  INTANGIBLE ASSETS, NET AND OTHER ASSETS

 

At December 31, intangible assets, net consisted of the following:

 

 

 

 

 

December 31, 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

 

$

46,200

 

$

52,800

 

$

99,000

 

$

39,600

 

$

59,400

 

DURASOLV technology

 

14 years

 

70,000

 

21,304

 

48,696

 

70,000

 

16,435

 

53,565

 

ACTIQ marketing rights

 

10-12 years

 

83,454

 

53,637

 

29,817

 

83,454

 

46,183

 

37,271

 

GABITRIL product rights

 

9-15 years

 

107,148

 

61,848

 

45,300

 

107,215

 

54,636

 

52,579

 

TRISENOX product rights

 

8-13 years

 

111,945

 

31,022

 

80,923

 

113,836

 

22,749

 

91,087

 

VIVITROL product rights

 

15 years

 

 

 

 

110,000

 

12,833

 

97,167

 

AMRIX product rights

 

18 years

 

99,332

 

16,932

 

82,400

 

99,257

 

6,204

 

93,053

 

MYOCET trademark

 

20 years

 

143,077

 

21,462

 

121,615

 

194,653

 

19,465

 

175,188

 

Other product rights

 

5-20 years

 

289,337

 

143,556

 

145,781

 

269,956

 

111,438

 

158,518

 

 

 

 

 

$

1,003,293

 

$

395,961

 

$

607,332

 

$

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 $100.7 million, $90.5 million, and $81.7 million for the years ended December 31, 2008, 2007, and 2006, respectively.

 

A payment of $25 million, made in March 2008 upon FDA approval of TREANDA, was capitalized as an intangible asset and will be amortized over the useful life of the product.  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, Cephalon and Eurand, 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 version of the 15 mg and 30 mg strengths of AMRIX.  In November 2008, we received a similar certification letter from Impax Laboratories, Inc.  In late November 2008, Cephalon and Eurand filed a

 



 

lawsuit in U.S. District Court in Delaware against Mylan and Barr for infringement of the Eurand Patent.  In January 2009, Cephalon and Eurand filed a lawsuit in U.S. District Court in Delaware against Impax for infringement of the Eurand Patent.  These lawsuits are further described in Note 15.  We do not believe that this has an effect on our useful life of AMRIX at this time.

 

Estimated amortization expense of intangible assets for each of the next five years is $85.2 million in 2009, $76.1 million in 2010, $68.9 million in 2011, $59.3 million in 2012 and $49.0 million in 2013. For further discussion of the status of the re-examination of our DURASOLV patents, see Note 15 herein.

 

Impairment Charges

 

On November 26, 2008, we entered into a termination agreement (the “Termination Agreement”) with Alkermes, Inc. to end our collaboration.  As of December 1, 2008, we are no longer responsible for the marketing and sale of VIVITROL  in the United States.  The Termination Agreement is intended to reduce our cost structure and enhance competitiveness.  Pursuant to the Termination Agreement, we will incur certain costs associated with exit or disposal activities.  The pretax charges associated with the Termination Agreement total $119.8 million.  These charges include (i) cash charges, classified as selling, general and administrative expenses within our statement of operations, of $12.2 million, consisting of a termination payment of $11.0 million to Alkermes and severance costs of $1.2 million and (ii) non-cash charges of $107.6 million, consisting of the $17.2 million loss on sale of the Product Manufacturing Equipment and other Capital Improvements (as such terms are defined in the supply agreement effective as of June 23, 2005 between the parties, as amended to date) and the $90.4 million impairment charge to write-off the net book value of the VIVITROL intangible assets from the U.S. segment, which have been classified as a loss on sale of equipment and an impairment charge within our statement of operations, respectively.  These pretax charges have been recognized in the fourth quarter 2008.

 

In June 2006, we announced that data from our Phase III clinical program evaluating GABITRIL for the treatment of generalized anxiety disorder (“GAD”) did not reach statistical significance on the primary study endpoints. We have no further plans to continue studying GABITRIL for the treatment of GAD. As a result, we performed a test of impairment on the carrying value of our investment in GABITRIL product rights and recorded an impairment charge of $12.4 million in the second quarter of 2006 related to our European rights.

 

11.   ACCRUED EXPENSES

 

At December 31, accrued expenses consisted of the following:

 

 

 

2008

 

2007

 

Accrued settlement reserve

 

$

 

$

425,000

 

Accrued compensation and benefits

 

51,383

 

52,749

 

Accrued contractual sales allowances

 

76,769

 

51,400

 

Accrued product sales returns allowances

 

36,423

 

25,335

 

Accrued sales and marketing costs

 

32,721

 

24,412

 

Accrued license fees and royalties

 

25,015

 

13,391

 

Accrued income taxes

 

13,933

 

18,063

 

Accrued clinical trial fees

 

7,973

 

5,069

 

Accrued research and development

 

2,140

 

4,625

 

Accrued product related costs

 

 

10,347

 

Other accrued expenses

 

58,058

 

46,793

 

 

 

$

304,415

 

$

677,184

 

 

For the year ended December 31, 2007, we recorded a settlement reserve of $425.0 million related to the terms of the agreement in principle reached with the U.S. Attorney’s Office, which was paid in 2008.  See Note 15 herein.

 



 

12.  LONG-TERM DEBT AND REDEEMABLE EQUITY

 

At December 31, long-term debt consisted of the following:

 

 

 

As Adjusted
2008(1)

 

As Adjusted
2007(1)

 

2.0% convertible senior subordinated notes due June 1, 2015

 

$

820,000

 

$

820,000

 

Debt discount on 2.0% convertible senior subordinated notes due June 1, 2015

 

(230,614

)

(257,587

)

Zero Coupon convertible subordinated notes first putable June 2008

 

 

213,564

 

Debt discount on Zero Coupon convertible subordinated notes first putable June 2008

 

 

(5,862

)

Zero Coupon convertible subordinated notes first putable June 2010

 

199,888

 

199,806

 

Debt discount on Zero Coupon convertible subordinated notes first putable June 2010

 

(17,789

)

(29,061

)

Mortgage and building improvement loans

 

1,288

 

2,165

 

Capital lease obligations

 

2,229

 

2,841

 

Acusphere, Inc. obligations

 

8,896

 

 

Other

 

1,412

 

2,581

 

Total debt

 

785,310

 

948,447

 

Less current portion

 

(781,618

)

(944,659

)

Total long-term debt

 

$

3,692

 

$

3,788

 

 


(1)          As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

 

As of January 1, 2009, we adopted the provisions of FSP APB 14-1.  FSP APB 14-1 amends APG 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 liability and equity components of the convertible debt separately.  The liability component is computed based on the fair value of a similar liability that does not include the conversion option.  The equity component is computed based on the total debt proceeds less the fair value of the liability component.   The equity component (debt discount) and debt issuance costs are amortized as interest expense over the expected term of the debt facility.   We adopted the provisions of FSP APB 14-1 on a retrospective basis for all prior periods presented.   In association with FSP APB 14-1 and in accordance with FASB Topic No. D-98, we have also presented a temporary equity classification “redeemable equity,” to highlight cash obligations that are attached to an equity security in order to distinguish this value from permanent capital.

 

At December 31, 2008, we have included $1.8 million of long-term debt and $7.1 million of short-term debt related to Acusphere, a variable interest entity for which we are the primary beneficiary.  Acusphere liabilities represent contractual obligations of Acusphere for intellectual property rights, equipment financing, construction financing and lease obligations.  Acusphere’s creditors have no recourse to the general credit of Cephalon.

 

Aggregate maturities of long-term debt at December 31, 2008 are as follows:

 

2009

 

$

781,618

(1)

 

 

2010

 

2,698

 

 

 

2011

 

518

 

 

 

2012

 

153

 

 

 

2013

 

161

 

 

 

2014 and thereafter

 

162

 

 

 

 

 

$

785,310

 

 

 

 


(1)          As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

 

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 2010 Notes, respectively at the balance sheet date. At December 31, 2008, our stock price was $77.04 and, therefore, all of our convertible notes are considered to be current liabilities and are presented in current portion of long-term debt on our consolidated balance sheet.  At December 31, 2007, our stock price was $71.76, and, therefore, all of our convertible notes were considered to be current liabilities and are presented in 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 customary 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 did occur, we believe that we have the ability to fund the payment of 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.

 



 

Gain (Charge) on Extinguishment of Debt

 

For the year ended December 31, 2007, we recognized a $5.3 million gain on extinguishment of debt related to the Pennsylvania Industrial Development Authority (“PIDA”) loan forgiveness.  See “Mortgage and Building Improvement Loans” below.

 

In December 2006, certain holders of our Zero Coupon Notes and 2.0% Notes approached us and we agreed to exchange $436.9 million aggregate principal amount of our convertible notes for cash payments totaling $175.3 million and the issuance of 6.2 million shares of our common stock.  We recorded $310.1 million in additional paid-in capital related to the shares issued.  Concurrent with these exchanges, we amended our convertible note hedge agreements (described below) related to the Zero Coupon Notes and 2.0% Notes and amended the warrant agreements related to the Zero Coupon Notes.  The effect of these amendments was to terminate the portion of the convertible note hedge and, with respect to the Zero Coupon Notes, the warrants agreements related to the $436.9 million principal amount of notes exchanged.  In settlement of these amendments, we received 1.8 million shares of our common stock from the counterparties to these agreements.  We recorded $129.5 million in additional paid-in capital and treasury stock related to the shares received.  The warrants related to the 2.0% Notes exchanged in December 2006 remain outstanding.

 

For the year ended December 31, 2006, we recognized $41.1 million of debt exchange expense in accordance with SFAS No. 84, “Induced Conversion of Convertible Debt” (“SFAS 84”) as follows:

 

 

 

Fair value of cash
and securities
transferred

 

Fair value issuable
under original
conversion

 

Total debt
exchange expense

 

Zero Coupon Notes

 

$

445,617

 

$

421,433

 

$

24,184

 

2.0% Notes

 

167,335

 

150,413

 

16,922

 

Total for 2006

 

$

612,952

 

$

571,846

 

$

41,106

 

 

2.0% Convertible Senior Subordinated Notes

 

In June and July 2005, we issued through a public offering $920 million of 2.0% Notes, of which $820 million remains outstanding as of December 31, 2008. Interest on the 2.0% Notes is payable semi-annually in arrears on June 1 and December 1 of each year, commencing December 1, 2005.

 

The 2.0% Notes are subordinated to our existing and future senior indebtedness and senior to our existing and future subordinated indebtedness. The 2.0% Notes are convertible prior to maturity, subject to certain conditions described below, into cash and shares of our common stock at an initial conversion price of $46.70 per share, subject to adjustment (equivalent to a conversion rate of approximately 21.4133 shares per $1,000 principal amount of 2.0% Notes).

 

The 2.0% Notes also contain a restricted convertibility feature that does not affect the conversion price of the 2.0% Notes but, instead, places restrictions on a holder’s ability to convert their 2.0% Notes into shares of our common stock (the “conversion shares”). A holder may convert the 2.0% Notes prior to December 1, 2014 only if one or more of the following conditions are satisfied:

 

·                  if, on the trading day prior to the date of surrender, the closing sale price of our common stock is more than 120% of the applicable conversion price per share (the “conversion price premium”);

 

·                  if the average of the trading prices of the 2.0% Notes for any five consecutive trading day period is less than 100% of the average of the conversion values of the 2.0% Notes during that period; or

 

·                  if we make certain significant distributions to our holders of common stock; we enter into specified corporate transactions; or our common stock ceases to be approved for listing on the NASDAQ Stock Market and is not listed for trading on a U.S. national securities exchange or any similar U.S. system of automated securities price dissemination.

 

Holders also may surrender their 2.0% Notes for conversion anytime after December 1, 2014 and on or prior to the close of business on the business day immediately preceding the maturity date, regardless if any of the foregoing conditions have been satisfied. Upon the satisfaction of any of the foregoing conditions as of the last day of the reporting period, or during the twelve months prior to December 1, 2014, we would classify the then-aggregate principal balance of the 2.0% Notes as a current liability on our consolidated balance sheet.

 



 

Each $1,000 principal amount of the 2.0% Notes is convertible into cash and shares of our common stock, if any, based on an amount (the “Daily Conversion Value”), calculated for each of the twenty trading days immediately following the conversion date (the “Conversion Period”). The Daily Conversion Value for each trading day during the Conversion Period for each $1,000 aggregate principal amount of the 2.0% Notes is equal to one-twentieth of the product of the then applicable conversion rate multiplied by the volume weighted average price of our common stock on that day.

 

For each $1,000 aggregate principal amount of the 2.0% Notes surrendered for conversion, we will deliver the aggregate of the following for each trading day during the Conversion Period:

 

(1)         if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of the 2.0% Notes exceeds $50.00, (a) a cash payment of $50.00 and (b) the remaining Daily Conversion Value in shares of our common stock; or

 

(2)         if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of the 2.0% Notes is less than or equal to $50.00, a cash payment equal to the Daily Conversion Value.

 

If the 2.0% Notes are converted in connection with certain fundamental changes that occur prior to June 2015, we may be obligated to pay an additional (or “make whole”) premium with respect to the 2.0% Notes so converted.

 

Convertible Note Hedge and Warrant Agreements

 

Concurrent with the sale of the 2.0% Notes, we purchased convertible note hedges from Deutsche Bank AG (“DB”) at a cost of $382.3 million. We also sold to DB warrants to purchase an aggregate of 19,700,214 shares of our common stock and received net proceeds from the sale of these warrants of $217.1 million. At issuance, the convertible note hedge and warrant agreements, taken together, have the effect of increasing the effective conversion price of the 2.0% Notes from our perspective to $67.92 per share if held to maturity. At our option, the warrants may be settled in either net cash or net shares. The convertible note hedge must be settled using net shares. Under the convertible note hedge, DB will deliver to us the aggregate number of shares we are required to deliver to a holder of 2.0% Notes that presents such notes for conversion. If the market price per share of our common stock is above $67.92 per share, we will be required to deliver either shares of our common stock or cash to DB representing the value of the warrants in excess of the strike price of the warrants. In accordance with EITF Issue No. 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled In, a Company’s Own Stock” (“EITF 00-19”) and SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity” (“SFAS 150”), we recorded the convertible note hedges and warrants in additional paid-in capital, and will not recognize subsequent changes in fair value. We also recognized a deferred tax asset of $133.8 million for the effect of the future tax benefits related to the convertible note hedge.

 

The warrants have a strike price of $67.92. The warrants are exercisable only on the respective expiration dates (European style). We issued and sold the warrants to DB in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended, because the offer and sale did not involve a public offering. There were no underwriting commissions or discounts in connection with the sale of the warrants.

 

Zero Coupon Convertible Subordinated Notes

 

In June 2003, we issued and sold in a private placement $750.0 million of Zero Coupon Convertible Notes. The interest rate on the notes is zero and the notes do not accrete interest. The notes were issued in two tranches: $375.0 million of Zero Coupon Convertible Subordinated Notes Due 2033, First Putable June 15, 2008 (the “Old 2008 Notes”) and $375.0 million of Zero Coupon Convertible Subordinated Notes Due 2033, First Putable June 15, 2010 (the “Old 2010 Notes” and, together with the Old 2008 Notes, the “Old Notes”).

 

In November 2004, we commenced an offer to exchange our 2008 Notes and our 2010 Notes for any and all of our outstanding Old 2008 Notes and Old 2010 Notes. Upon expiration of the exchange offer, we issued $374.7 million principal amount at maturity of 2008 Notes in exchange for a like principal amount at maturity of our outstanding Old 2008 Notes and $374.9 million principal amount at maturity of 2010 Notes in exchange for a like principal amount at maturity of our outstanding Old 2010 Notes. Following our exchange of convertible debt for cash and stock in December 2006, there remains outstanding as of December 31, 2008, $199.5 million aggregate principal amount of the  2010 Notes.

 

The Zero Coupon  Notes were issued solely to our existing security holders pursuant to our offer to exchange, which was made in reliance upon the exemption from the registration requirement of the Securities Act afforded by Section 3(a)(9) thereof. We did not pay or give, directly or indirectly, any commission or other remuneration for solicitation of the exchange of the Old Notes for the Zero Coupon Notes.

 



 

During the second quarter of 2008, we delivered a notice of redemption to the holders of our 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. In 2006, our Zero Coupon Notes became convertible and the related deferred debt issuance costs of $13.1 million were written off.

 

The 2008 Notes were first putable on June 15, 2008 at a price of 100.25% of the face amount of the 2008 Notes. The holders of the 2008 Notes were also entitled to require us to repurchase all or a portion of the 2008 Notes for cash on June 15, 2013, June 15, 2018, June 15, 2023 and June 15, 2028, in each case at a price equal to the face amount of the 2008 Notes. The 2008 Notes were convertible prior to maturity, subject to certain conditions described below, into cash and shares of our common stock at a conversion price of $59.50 per share (an equivalent conversion rate of approximately 16.8067 shares per $1,000 principal amount of notes). We redeemed any outstanding 2008 Notes for cash in June  2008 at a price equal to 100.25% of the principal amount of such notes.

 

The 2010 Notes are first putable for cash on June 15, 2010 at a price of 100.25% of the face amount of the 2010 Notes. The holders of the 2010 Notes may also require us to repurchase all or a portion of the 2010 Notes for cash on June 15, 2015, June 15, 2020, June 15, 2025 and June 15, 2030, in each case at a price equal to the face amount of the 2010 Notes. The 2010 Notes are convertible prior to maturity, subject to certain conditions described below, into cash and shares of our common stock at a conversion price of $56.50 per share (an equivalent conversion rate of approximately 17.6991 shares per $1,000 principal amount of notes). We may redeem any outstanding 2010 Notes for cash on June 15, 2010 at a price equal to 100.25% of the principal amount of such notes redeemed and after June 15, 2010 at a price equal to 100% of the principal amount of such notes redeemed.

 

The 2010 Notes also contain restricted convertibility terms that do not affect the conversion price of the notes, but instead place restrictions on a holder’s ability to convert their notes into a combination of cash and shares of our common stock, as described below. A holder may convert the 2010 Notes only if one or more of the following conditions are satisfied:

 

·                  if, on the trading day prior to the date of surrender, the closing sale price of our common stock is more than 120% of the applicable conversion price per share;

 

·                  if we have called the 2010 Notes for redemption;

 

·                  if the average of the trading prices of the applicable 2010 Notes for a specified period is less than 100% of the average of the conversion values of the 2010 Notes during that period; provided, however, that no 2010 Notes may be converted based on the satisfaction of this condition during the six-month period immediately preceding each specified date on which the holders may require us to repurchase their notes (for example, with respect to the June 15, 2010 put date for the 2010 Notes, the 2010 Notes may not be converted from December 15, 2009 to June 15, 2010); or

 

·                  if we make certain significant distributions to holders of our common stock, if we enter into specified corporate transactions or if our common stock is neither listed for trading on a U.S. national securities exchange or any similar U.S. system of automated securities price dissemination (a “Fundamental Change”).

 

Upon the satisfaction of any one of these conditions, we would classify the then-aggregate outstanding principal balance of 2010 Notes as a current liability on our consolidated balance sheet.

 

Each $1,000 principal amount of 2010 Notes is convertible into cash and shares of our common stock, if any, based on an amount (the “Daily Conversion Value”), calculated for each of the ten trading days immediately following the conversion date (the “Conversion Period”). The Daily Conversion Value for each trading day during the Conversion Period for each $1,000 aggregate principal amount of  2010 Notes is equal to one-tenth of the product of the then applicable conversion rate multiplied by the volume weighted average price of our common stock on that day.

 

For each $1,000 aggregate principal amount of 2010 Notes surrendered for conversion, we will deliver the aggregate of the following for each trading day during the Conversion Period:

 



 

(1)         if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of 2010 Notes exceeds $100.00, (a) a cash payment of $100.00 and (b) the remaining Daily Conversion Value in shares of our common stock; or

 

(2)         if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of 2010 Notes is less than or equal to $100.00, a cash payment equal to the Daily Conversion Value.

 

If the 2010 Notes are converted in connection with a Fundamental Change that occurs prior to June 15, 2010, we may also be obligated to pay an additional premium with respect to the 2010 Notes so converted.

 

Convertible Note Hedge

 

Concurrent with the private placement of the Old Notes, we purchased a convertible note hedge from Credit Suisse First Boston International (“CSFBI”) at a cost of $258.6 million. We also sold to CSFBI warrants to purchase an aggregate of 12,939,689 shares of our common stock and received net proceeds from the sale of $178.3 million.  Following the December 2006 amendment of the warrant agreements, the expiration of the warrants associated with the 2008 Notes, and conversions of the 2010 Notes that occur from time to time, there remain outstanding warrants to purchase 3,532,035 shares of our common stock.  In connection with our exchange of Old Notes for Zero Coupon Notes, we amended the convertible note hedge to reflect the mandatory net share settlement feature of the Zero Coupon Notes. Taken together, the convertible note hedge and warrants have the effect of increasing the effective conversion price of the Zero Coupon Notes from our perspective to $72.08 if held to maturity, a 50% premium to the last reported NASDAQ composite bid for our common stock on the day preceding the date of the original agreements. At our option, the warrants may be settled in either net cash or net shares; the convertible note hedge must be settled using net shares. Under the convertible note hedge, CSFBI will deliver to us the aggregate number of shares we are required to deliver to a holder of Zero Coupon Notes that presents such Zero Coupon Notes for conversion, provided, however, that if the market price per share of our common stock is above $72.08, we will be required to deliver either shares of our common stock or cash to CSFBI representing the value of the warrants in excess of the strike price of the warrants. In accordance with EITF No. 00-19 and SFAS 150, we recorded the convertible note hedge and warrants in additional paid-in capital as of June 30, 2003, and do not recognize subsequent changes in fair value. We also recognized a deferred tax asset of $90.5 million in the second quarter of 2003 for the effect of the future tax benefits related to the convertible note hedge.

 

The warrants have a strike price of $72.08.  The 3,532,035 warrants outstanding as of December 31, 2008 are associated with the 2010 Notes and expire on June 15, 2010.  The warrants are exercisable only on the respective expiration dates (European style) or upon the conversion of the notes, if earlier.

 

Mortgage and Building Improvement Loans

 

In March 1995, we purchased the buildings housing our administrative offices and research facilities in West Chester, Pennsylvania for $11.0 million. We financed the purchase through the assumption of an existing $6.9 million first mortgage and from $11.6 million in state funding provided by the Commonwealth of Pennsylvania. The first mortgage has a 15-year term with an annual interest rate of 9.625%. The state funding has a 15-year term with an annual interest rate of 2%. The loans require annual aggregate principal and interest payments of $1.8 million. The loans are secured by the buildings and by all our equipment located in Pennsylvania that is otherwise unsecured.

 

In November 2002, in connection with our planned relocation to a new corporate headquarters, the PIDA board authorized the forgiveness of the outstanding principal balance of $5.3 million due on a loan granted by PIDA in 1995, contingent upon the commencement of construction of a new headquarters facility in the Commonwealth of Pennsylvania no later than June 30, 2004 and our creation of a specified number of new jobs in the Commonwealth. At its meeting held June 8, 2004, the PIDA board approved the extension of the construction deadline until December 31, 2005, subject to the requirement that, effective July 1, 2004, we must commence payment of interest only on the original loan. In January 2006, the PIDA board voted to extend the deadline to December 31, 2007 for the job creation obligations, and eliminated the requirement to commence construction of a new headquarters facility by December 31, 2005. At a meeting held in September 2007, the PIDA board determined to forgive the outstanding principal balance of the loan.  As such, we recognized a $5.3 million gain on extinguishment of debt in the third quarter of 2007.

 

13.       STOCKHOLDERS’ EQUITY

 

Equity Compensation Plans

 

We have established equity compensation plans for our employees, directors and certain other individuals. The Stock Option and Compensation Committee of our Board of Directors approves all grants and the terms of such grants,

 



 

subject to ratification by the Board of Directors. We may grant non-qualified stock options under the Cephalon, Inc. 2004 Equity Compensation Plan (the “2004 Plan”) and the Cephalon, Inc. 2000 Equity Compensation Plan (the “2000 Plan”), and also may grant incentive stock options and restricted stock units under the 2004 Plan. Stock options and restricted stock units generally become exercisable or vest ratably over four years from the grant date, and stock options must be exercised within ten years of the grant date. There are currently 14.0 million and 4.3 million shares authorized for issuance under the 2004 Plan and the 2000 Plan, respectively. At December 31, 2008, the shares available for future grants of stock options or restricted stock units were 1,209,407, of which up to 116,300 may be issued as restricted stock units.

 

Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS 123(R), using the modified-prospective transition method. Under this transition method, stock-based compensation is recognized in the consolidated financial statements for stock granted. Compensation expense recognized in the financial statements includes estimated expense for stock options granted after December 31, 2005, based on the grant date fair value estimated in accordance with the provisions of SFAS 123(R), and the estimated expense for the stock options granted prior to, but not vested as of January 1, 2006, based on the grant date fair value estimated in accordance with the original provisions of SFAS 123. SFAS 123(R) also requires us to estimate forfeitures in calculating the expense relating to stock-based compensation as opposed to only recognizing forfeitures and the corresponding reduction in expense as they occur. We recorded an adjustment for this cumulative effect for restricted stock units and recognized a reduction in stock-based compensation in the first quarter of 2006 consolidated statements of operations allocated equally between research and development and selling, general and administrative expenses based on the employees’ compensation allocation between these line items. The adjustment was not significant to the consolidated statement of operations.

 

Total stock-based compensation expense recognized in the consolidated statement of operations for the years ended December 31:

 

 

 

2008

 

2007

 

2006

 

Stock option expense

 

$

26,018

 

$

29,945

 

$

31,370

 

Restricted stock unit expense

 

17,956

 

16,750

 

11,437

 

Total stock-based compensation expense*

 

$

43,974

 

$

46,695

 

$

42,807

 

Total stock-based compensation expense after-tax

 

$

28,583

 

$

29,558

 

$

27,097

 

 


* Beginning with the second half 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. From 2006 through the first half of 2008, 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.

 

Compensation expense is recognized in the period the employee performs the service in accordance with SFAS 123(R). For the year ended December 31, 2006, the impact of the adoption of SFAS 123(R) on basic and diluted income per common share was $0.32 and $0.28, respectively. The impact of capitalizing stock-based compensation was not significant at December 31, 2008, 2007 and 2006 respectively.

 

During the second quarter of 2006, we elected to adopt the short-cut method of FASB Staff Position No. SFAS 123(R)-3 “The Transition Election Related to Accounting for the Tax Effects of Share Based Payment Awards” (“FSP SFAS 123(R)-3”) to determine our pool of windfall tax benefits under SFAS 123(R).  Under the short-cut method, our historical pool of windfall tax benefits was calculated as cumulative net increases to additional paid-in capital related to tax benefits from stock-based compensation after the election date of SFAS 123 less the product of cumulative SFAS 123 compensation cost, as adjusted, multiplied by the blended statutory tax rate at adoption of SFAS 123(R).  Using this calculation, we determined our historical windfall tax pool was zero as of January 1, 2006. Following the guidance within FSP SFAS 123(R)-3, we retrospectively applied the short-cut method to our consolidated financial statements for the three months ended March 31, 2006.  Under the transition provisions of the short-cut method, for awards fully vested at the adoption date of SFAS 123(R) and subsequently settled, the pool of windfall tax benefits is equal to the total tax benefit recognized in additional paid-in capital upon settlement.  Prior to the election of the short-cut method, we accounted for the on-going income tax effects for partially or fully vested awards as of the date of SFAS 123(R) adoption using the “as if” method of accounting required by the long-form method under SFAS 123(R).  The retrospective application adjustments to our consolidated financial statements for the three months ended March 31, 2006 had no impact on our financial position or results of operations.  For the three months ended March 31, 2006, there was no change to our total net cash flows; however, our net cash used for operating activities increased by $21.5 million to $33.6 million and our net cash provided by financing activities increased by $21.5 million to $127.9 million.  Upon adoption during the second quarter of 2006, the impact of the

 



 

election was not significant to our consolidated financial statements. The cumulative pool of windfall tax benefits was $48.0 million and $40.8 million as of December 31, 2008 and 2007, respectively.

 

Based on our historical experience of stock option and restricted stock unit pre-vesting forfeitures, we have assumed the following weighted average expected forfeiture rates over the four year life of the stock option and restricted stock unit for all new stock options and restricted stock units granted, excluding stock options and restricted stock units granted to the Chief Executive Officer and members of the Board of Directors for which a zero forfeiture rate is assumed, for the years ended December 31:

 

 

 

2008

 

2007

 

2006

 

Stock option expected forfeiture rate

 

13.9

%

12.7

%

12.2

%

Restricted stock unit expected forfeiture rate

 

16.5

%

14.4

%

12.2

%

 

Under the provisions of SFAS 123(R), we will record additional expense if the actual pre-vesting forfeiture rate is lower than we estimated and will record a recovery of prior expense if the actual forfeitures are higher than our estimate.

 

Beginning with our December 2007 stock option grant, our expected term of stock options granted was derived from our historical data as we have assumed that our historical stock option exercise experience is a relevant indicator of future exercise patterns. Prior to the December 2007 stock option grant, our expected term of stock options granted was derived from the average midpoint between vesting and the contractual term, as described in SEC’s Staff Accounting Bulletin No. 107, “Share-Based Payment.”  Expected volatilities are based on a combination of implied volatilities from traded options on our stock and the historical volatility of our stock for the related vesting period. The risk-free interest rate is based on the implied yield available on U.S. Treasury zero-coupon issues with an equivalent term. We have not paid dividends in the past and do not plan to pay any dividends in the foreseeable future.

 

The fair value of each stock option grant at the grant date is calculated using the Black-Scholes option-pricing model with the following weighted average assumptions for the years ended December 31:

 

 

 

2008

 

2007

 

2006

 

Risk free interest rate

 

2.16

%

3.73

%

4.62

%

Expected term (years)

 

5.62

 

5.64

 

6.18

 

Expected volatility

 

35.6

%

32.5

%

41.0

%

Expected dividend yield

 

%

%

%

 

 

 

 

 

 

 

 

Estimated fair value per stock option granted

 

$

26.75

 

$

28.64

 

$

33.20

 

 

On May 17, 2007, the 2004 Plan was amended, following approval by Cephalon stockholders, to increase by 1,000,000 shares the total number of shares of common stock authorized for issuance under the 2004 Plan, from 11,450,000 shares to 12,450,000 shares. This amendment also provides that no more than 400,000 shares of common stock may be issued pursuant to restricted stock unit awards granted under the 2004 Plan after May 16, 2007.

 

On May 23, 2008, the 2004 Plan was further amended, following approval by Cephalon stockholders, to increase by 1,500,000 shares the total number of shares of common stock authorized for issuance under the 2004 Plan, from 12,450,000 shares to 13,950,000 shares.  This amendment also provides that no more than 500,000 shares of common stock may be issued pursuant to restricted stock unit awards granted under the 2004 Plan after May 22, 2008.

 

Stock Options

 

The following tables summarize the aggregate stock option activity for the years ended December 31:

 

 

 

2008

 

 

 

Shares

 

Weighted
Average
Exercise Price

 

Weighted
Average
Remaining
Contractual
Life (years)

 

Aggregate
Intrinsic Value

 

Outstanding, January 1,

 

6,805,897

 

$

59.70

 

 

 

 

 

Granted

 

1,215,900

 

72.63

 

 

 

 

 

Exercised

 

(957,865

)

45.90

 

 

 

 

 

Forfeited

 

(293,263

)

67.67

 

 

 

 

 

Expired

 

(127,554

)

68.16

 

 

 

 

 

Outstanding, December 31,

 

6,643,115

 

$

63.54

 

7.0

 

$

89,959

 

Vested stock options at end of period

 

4,167,815

 

$

58.61

 

5.0

 

$

77,049

 

 



 

 

 

2007

 

 

 

Shares

 

Weighted
Average
Exercise Price

 

Weighted
Average
Remaining
Contractual
Life (years)

 

Aggregate
Intrinsic Value

 

Outstanding, January 1,

 

7,694,298

 

$

54.90

 

 

 

 

 

Granted

 

1,178,000

 

76.23

 

 

 

 

 

Exercised

 

(1,853,152

)

50.70

 

 

 

 

 

Forfeited

 

(193,175

)

57.87

 

 

 

 

 

Expired

 

(20,074

)

48.90

 

 

 

 

 

Outstanding, December 31,

 

6,805,897

 

$

59.70

 

6.6

 

$

87,496

 

Vested stock options at end of period

 

4,434,571

 

$

55.04

 

5.3

 

$

74,902

 

 

 

 

2006

 

 

 

Shares

 

Weighted
Average
Exercise Price

 

Weighted
Average
Remaining
Contractual
Life (years)

 

Aggregate
Intrinsic Value

 

Outstanding, January 1,

 

9,955,904

 

$

50.84

 

 

 

 

 

Granted

 

1,116,800

 

69.85

 

 

 

 

 

Exercised

 

(3,058,430

)

47.46

 

 

 

 

 

Forfeited

 

(305,475

)

50.54

 

 

 

 

 

Expired

 

(14,501

)

50.62

 

 

 

 

 

Outstanding, December 31,

 

7,694,298

 

$

54.90

 

6.7

 

$

121,836

 

Vested stock options at end of period

 

5,143,900

 

$

53.39

 

5.6

 

$

89,430

 

 

As of December 31, 2008, there was $45.8 million of total unrecognized compensation cost related to outstanding stock options that is expected to be recognized over a weighted-average period of 1.6 years. For the years ended December 31, 2008, 2007 and 2006, we received net proceeds of $44.0 million, $93.9 million and $143.5 million, respectively, from the exercise of stock options.

 

The intrinsic value of stock options exercised for the years ended December 31, 2008, 2007 and 2006 was $26.2 million, $50.2 million and $79.8 million, respectively. The estimated fair value of shares that vested for the years ended December 31, 2008, 2007 and 2006 was $24.8 million, $35.6 million and $40.8 million, respectively.

 

Restricted Stock Units

 

The following tables summarize the restricted stock units activity for the years ended December 31:

 

 

 

2008

 

 

 

Shares

 

Weighted Average
Fair Value

 

Nonvested, January 1,

 

747,050

 

$

67.82

 

Granted

 

383,700

 

73.25

 

Vested

 

(253,837

)

62.84

 

Forfeited

 

(85,025

)

67.49

 

Nonvested, December 31,

 

791,888

 

$

72.08

 

Intrinsic value as of December 31,

 

$

61,007

 

 

 

 

 

 

2007

 

 

 

Shares

 

Weighted Average
Fair Value

 

Nonvested, January 1,

 

709,900

 

$

59.49

 

Granted

 

324,850

 

76.11

 

Vested

 

(250,125

)

55.92

 

Forfeited

 

(37,575

)

61.30

 

Nonvested, December 31,

 

747,050

 

$

67.82

 

Intrinsic value as of December 31,

 

$

53,608

 

 

 

 



 

 

 

2006

 

 

 

Shares

 

Weighted Average
Fair Value

 

Nonvested, January 1,

 

624,575

 

$

49.52

 

Granted

 

325,900

 

71.06

 

Vested

 

(180,125

)

49.23

 

Forfeited

 

(60,450

)

49.48

 

Nonvested, December 31,

 

709,900

 

$

59.49

 

Intrinsic value as of December 31,

 

$

49,984

 

 

 

 

As of December 31, 2008, there was $38.7 million of total unrecognized compensation cost related to nonvested restricted stock units that is expected to be recognized over a weighted-average period of 1.6 years.

 

Qualified Savings and Investment Plan

 

We have a profit sharing plan pursuant to section 401(k) of the Internal Revenue Code.  As of January 1, 2007, participants are permitted to contribute any whole percentage of their eligible annual pre-tax compensation up to established federal limits on aggregate participant contributions. For the year ended December 31, 2006, participants were permitted to contribute up to 20 percent of their eligible annual pre-tax compensation up to established federal limits on aggregate participant contributions.  Our discretionary matching contribution is made solely in cash on 100 percent of the employee elected salary deferral up to six percent of eligible compensation. For the years ended December 31, 2008, 2007, and 2006, we contributed $12.3 million, $12.6 million and $11.8 million to the plan, respectively.

 

Pro forma Aggregate Conversions or Exercises

 

At December 31, 2008, the conversion or exercise of all outstanding stock options and restricted stock units would increase the outstanding number of shares of common stock by 7.4 million shares, or 11%. The conversion of our convertible subordinated notes and warrants into shares of Cephalon common stock in accordance with their terms is dependent upon actual stock price at the time of conversion.

 

Preferred Share Purchase Rights

 

In November 1993, our Board of Directors declared a dividend distribution of one right for each outstanding share of common stock. In addition, a right attaches to and trades with each new issue of our common stock. Each right entitles each registered holder, upon the occurrence of certain events, to purchase from us a unit consisting of one one-hundredth of a share of our Series A Junior Participating Preferred Stock, or a combination of securities and assets of equivalent value, at a purchase price of $200.00 per unit, subject to adjustment.

 

14.  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:

2.5% Notes (outstanding through December 2006)

 



 

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”; 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, 2008 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.

 

The number of shares included in the diluted EPS calculation for the convertible subordinated notes and warrants for the years ended December 31:

 

(In thousands, except per share data)

 

2008

 

2007*

 

2006

 

Average market price per share of Cephalon stock

 

$

69.42

 

$

74.90

 

$

66.05

 

 

 

 

 

 

 

 

 

Shares included in diluted EPS calculation:

 

 

 

 

 

 

 

2.0% Notes

 

5,747

 

 

5,755

 

New Zero Coupon Notes

 

813

 

 

1,553

 

Warrants related to 2.0% Notes

 

425

 

 

Warrants related to New Zero Coupon Notes

 

 

 

Total (Treasury Stock Method)

 

6,985

 

 

7,308

 

Other (“If-Converted” Method)

 

4

 

 

124

 

Total

 

6,989

 

 

7,432

 

 


* Since there was a net loss for the year ended December 31, 2007, there is no impact from these notes or warrants on the number of diluted shares included in the diluted EPS calculation.

† No shares are included because the average market price per share of our common stock did not exceed the warrant strike prices of the 2.0% and New Zero Coupon Notes.

 

The following is a reconciliation of net income (loss) and weighted average common shares outstanding for purposes of calculating basic and diluted income (loss) per common share for the years ended December 31:

 



 

(In thousands, except per share data)

 

2008

 

As Adjusted
2007
1

 

As Adjusted
2006
1

 

Basic income (loss) per common share computation:

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

Net income (loss) attributable to Cephalon, Inc., used for basic income (loss) per common share

 

$

192,962

 

$

(226,429

)

$

115,642

 

Denominator:

 

 

 

 

 

 

 

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

 

68,018

 

66,597

 

60,507

 

 

 

 

 

 

 

 

 

Basic income (loss) per common share attributable to Cephalon, Inc.,

 

$

2.84

 

$

(3.40

)

$

1.91

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share computation:

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

Net income (loss) attributable to Cephalon, Inc., used for basic income (loss) per common share

 

$

192,962

 

$

(226,429

)

$

115,642

 

Interest on convertible notes, net of tax

 

 

 

154

 

Net income (loss) attributable to Cephalon, Inc., used for diluted income (loss) per common share

 

$

192,962

 

$

(226,429

)

$

115,796

 

Denominator:

 

 

 

 

 

 

 

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

 

68,018

 

66,597

 

60,507

 

Effect of dilutive securities:

 

 

 

 

 

 

 

Convertible subordinated notes and warrants

 

6,989

 

 

7,432

 

Employee stock options and restricted stock units

 

1,090

 

 

1,733

 

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

 

76,097

 

66,597

 

69,672

 

 

 

 

 

 

 

 

 

Diluted income (loss) attributable to Cephalon, Inc., per common share

 

$

2.54

 

$

(3.40

)

$

1.66

 

 


(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements.

 

The following reconciliation shows the shares excluded from the calculation of diluted income (loss) per common share as the inclusion of such shares would be anti-dilutive for the years ended December 31:

 

(In thousands)

 

2008

 

2007

 

2006

 

Weighted average shares excluded:

 

 

 

 

 

 

 

Convertible subordinated notes and warrants

 

25,006

 

35,042

 

26,821

 

Employee stock options and restricted stock units

 

2,963

 

2,888

 

2,693

 

 

 

27,969

 

37,930

 

29,514

 

 

15.  COMMITMENTS AND CONTINGENCIES

 

Leases

 

We lease certain of our offices and automobiles under operating leases in the United States and Europe that expire at various times through 2022. Lease expense under all operating leases totaled $22.6 million, $22.7 million and $20.0 million in 2008, 2007, and 2006, respectively.

 

Estimated lease expense for each of the next five years as of December 31, 2008 is as follows:

 

2009

 

$

18,379

 

 

 

 

 

2010

 

15,119

 

 

 

 

 

2011

 

12,003

 

 

 

 

 

2012

 

9,904

 

 

 

 

 

2013

 

9,383

 

 

 

 

 

2014 and thereafter

 

29,662

 

 

 

 

 

 

 

$

 94,450

 

 

 

 

 

 

Cephalon Clinical Partners, L.P.

 

In August 1992, we exclusively licensed our rights to MYOTROPHIN Injection for human therapeutic use within the United States, Canada and Europe to Cephalon Clinical Partners, L.P. (“CCP”). Development and clinical testing of MYOTROPHIN is performed on behalf of CCP under a research and development agreement with CCP.

 

CCP has granted us an exclusive license to manufacture and market MYOTROPHIN for human therapeutic use within the United States, Canada and Europe in return for royalty payments equal to a percentage of product sales and a milestone payment of approximately $12.4 million that will be made if MYOTROPHIN receives regulatory approval.

 



 

We have a contractual option, but not an obligation, to purchase all of the limited partnership interests of CCP, which is exercisable upon the occurrence of certain events following the first commercial sale of MYOTROPHIN. If, and only if, we decide to exercise this purchase option, we would make an advance payment of approximately $30.9 million in cash or, at our election, approximately $32.5 million in shares of common stock or a combination thereof. Should we discontinue development of MYOTROPHIN, or if we do not exercise this purchase option, our license will terminate and all rights to manufacture or market MYOTROPHIN in the United States, Canada and Europe will revert to CCP, which may then commercialize MYOTROPHIN itself or license or assign its rights to a third party. In that event, we would not receive any benefits from such commercialization, license or assignment of rights.

 

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.

 

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 minimum amounts of modafinil through 2012, with aggregate remaining purchase commitments totaling $57.8 million as of December 31, 2008. Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  See Note 7 herein.

 

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.

 

Numerous private antitrust complaints have been 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.

 

AMRIX Patent Litigation

 

In October 2008, Cephalon and Eurand, Inc. (“Eurand”), received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan Pharmaceuticals, Inc. and Barr Laboratories, Inc., each requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX.  In November 2008, we received a similar certification letter from Impax Laboratories, Inc.  Mylan and Impax each allege that the U.S. Patent Number 7,387,793 (the “Eurand Patent”), entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants,” issued to Eurand will not be infringed by the manufacture, use or sale of the product described in the applicable ANDA and reserves the right to challenge the validity and/or enforceability of the Eurand Patent.  Barr alleges that the Eurand Patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA.  The Eurand Patent does not expire until February 26, 2025.  In late November 2008, Cephalon and Eurand filed a lawsuit in U.S. District Court in Delaware against Mylan (and its parent) and Barr (and its parent) for infringement of the Eurand Patent.  In January 2009, Cephalon and Eurand filed a lawsuit in U.S. District Court in Delaware against Impax for infringement of the Eurand Patent.  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.

 

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, 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.

 

While we intend to vigorously defend the AMRIX and FENTORA intellectual property rights, 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.

 



 

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. In September 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 of $0.6 million.  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.  All of the payments described above were made in the fourth quarter of 2008.

 

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.

 

In September 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.  In February 2009, we were served with an additional putative class action complaint filed on behalf of two health and welfare trust funds  that claim to have purchased GABITRIL and PROVIGIL for uses outside the products approved labels.  The complaint alleges violations of RICO and the common law of unjust enrichment and seeks an unspecified amount of money in actual, punitive and/or treble damages, with interest.  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 have cooperated with these requests and provided documents and other information to the Committee.

 



 

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 PTO notified us that, in response to re-examination petitions filed by a third party, the Examiner rejected the claims in the two U.S. patents for our DURASOLV ODT technology.  We disagree with the Examiner’s position, and we filed notices of appeal of the PTO’s decisions in the fourth quarter of 2007 regarding one patent and in the second quarter of 2008 regarding the second patent.  The appeals are pending.  While we intend to vigorously defend these patents, these efforts, ultimately, may not be successful.  The invalidity of the DURASOLV patents could have a material 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.

 

Other Commitments

 

We have committed to make potential future “milestone” payments to third parties as part of our in-licensing and development programs primarily in the area of research and development agreements. Payments generally become due and payable only upon the achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, we have not recorded a liability on our balance sheet for any such contingencies. As of December 31, 2008, the potential milestone and other contingency payments due under current contractual agreements are $701.7 million.

 

We have committed to make future minimum payments to third parties for certain raw material inventories. Under these contracts, we have agreed to purchase minimum amounts of modafinil through 2012, with aggregate purchase commitments totaling $57.8 million as of December 31, 2008.  Based on our current assessment, we have recorded a reserve of $26.0 million for purchase commitments for modafinil raw materials not expected to be utilized.  The minimum purchase commitments totaled $83.0 million as of December 31, 2007, the majority of which relate to modafinil and armodafinil.

 

Acusphere liabilities represent contractual obligations of Acusphere for intellectual property rights, equipment financing, construction financing and lease obligations.  Acusphere’s creditors have no recourse to the general credit of Cephalon.

 

16.  INCOME TAXES

 

In July 2006, the FASB issued FIN 48 which addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under FIN 48, a company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement.  FIN 48 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. We adopted the provisions of FIN 48 on January 1, 2007, and as a result of the adoption of FIN 48, we recognized a $33.9 million increase in the liability for unrecognized tax benefits.  This increase in liability resulted in a decrease to the January 1, 2007 retained earnings balance in the amount of $7.2 million, a net reduction in deferred tax liabilities of $18.5 million and a net increase in deferred tax assets of $8.2 million.

 

Unrecognized tax benefits for the year ended December 31:

 



 

 

 

2008

 

2007(1)

 

Unrecognized tax benefits beginning of year

 

$

79,593

 

$

50,551

 

Gross change for current year positions

 

7,591

 

15,890

 

Increase for prior period positions

 

2,986

 

15,348

 

Decrease for prior period positions

 

(21,347

)

(2,196

)

Decrease due to settlements and payments

 

(6,221

)

 

Decrease due to statute expirations

 

 

 

Unrecognized tax benefits end of year

 

$

62,602

 

$

79,593

 

 


(1) Year of adoption

 

The amount of unrecognized tax benefits at December 31, 2008 is $62.6 million and $79.6 million at December 31, 2007 of which $27.5 million and $27.8 million would impact our effective tax rate, respectively, if recognized. We do not believe that the total amount of unrecognized tax benefits will increase or decrease significantly over the next twelve months.

 

Interest expense related to income taxes is included in interest expense.  Net interest benefit related to unrecognized tax benefits for the year ended December 31, 2008 was $0.9 million compared to an expense of $2.5 million in 2007, principally due to the settlement of the 2003-2005 Internal Revenue Service (“IRS”) audit.  Accrued interest expense as of December 31, 2008 and December 31, 2007 was $3.0 million and $3.9 million respectively.    Income tax penalties are included in other income (expense). Tax penalties decreased during the year by $0.9 million. Accrued tax penalties are not significant.

 

During 2008 the IRS has completed its examination of Cephalon, Inc.’s 2003, 2004 and 2005 federal income tax returns.  We have been contacted by the IRS to begin the examination of the Cephalon, Inc. U.S. federal income tax returns for the years 2006 and 2007 during the first quarter of 2009.  Cephalon, Inc. remains open for examination by the IRS for the tax years ended 2006, 2007 and 2008. 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. During the fourth quarter of 2008 Cephalon Pharma GmbH, in Germany, completed its examination for 2000 - 2004 with no material findings. Cephalon Germany Gmbh is under examination for years 2004 - 2008.  Cephalon Pharma S.L., in Spain, is under examination for 2003 and during 2008 agreed to a proposal from the Spanish authorities to settle this examination.  We have reserved our right to appeal this settlement. Our filings in the United Kingdom remain open to examination for 2005- 2008.  In other significant foreign jurisdictions, the tax years that remain open for potential examination range from 2001 - 2008.  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 - 2005 IRS settlement is expected not to be material but will be subject to examinations, and the 2006 - 2008 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 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 15. During 2008 we realized a net benefit of $11.1 million related to the release of reserves related to the settlement of Cephalon, Inc.’s 2003 - 2005 IRS audit.

 

The components of income (loss) before income taxes for the years ended December 31:

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006 (1), (2), (3)

 

United States

 

$

157,722

 

$

(87,955

)

$

261,410

 

Foreign

 

(23,652

)

(35,321

)

(69,244

)

Total

 

$

134,070

 

$

(123,276

)

$

192,166

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

The components of the provision (benefit) for income taxes for the years ended December 31:

 



 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

Current taxes:

 

 

 

 

 

 

 

United States

 

$

21,587

 

$

101,090

 

$

61,182

 

Foreign

 

5,519

 

19,497

 

4,679

 

State

 

3,118

 

3,656

 

(487

)

 

 

30,224

 

124,243

 

65,374

 

Deferred taxes:

 

 

 

 

 

 

 

United States

 

(47,878

)

14,036

 

17,598

 

Foreign

 

(29,234

)

(95,299

)

(13,052

)

State

 

(4,901

)

1,684

 

(8,092

)

 

 

(82,103

)

(79,579

)

(3,546

)

Change in valuation allowance

 

13,970

 

58,489

 

14,696

 

 

 

(68,043

)

(21,090

)

11,150

 

Total

 

$

(37,819

)

$

103,153

 

$

76,524

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

A reconciliation of the United States Federal statutory rate to our effective tax rate for the years ended December 31:

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

U.S. Federal statutory rate—expense (benefit)

 

35.0

%

(35.0

)%

35.0

%

Manufacturers’ deduction

 

 

(5.1

)

(0.9

)

Meals and entertainment

 

2.5

 

2.3

 

1.3

 

Executive compensation

 

2.8

 

3.2

 

1.7

 

Other permanent book/tax differences

 

1.3

 

1.9

 

0.5

 

Revision of prior years’ estimates

 

6.3

 

(8.9

)

0.2

 

State income taxes, net of U.S. federal tax benefit

 

(2.9

)

4.9

 

(2.8

)

Tax rate differential & permanent items on foreign income

 

(3.9

)

(51.7

)

1.9

 

Change in valuation allowance

 

9.8

 

53.2

 

7.7

 

Research and development credit

 

(15.3

)

(6.9

)

(1.4

)

Settlement reserve

 

(61.4

)

120.8

 

 

Non-deductible loss of variable interest entity

 

8.5

 

 

 

Change in reserve for contingent liability

 

(10.7

)

5.7

 

(3.3

)

Other

 

(0.2

)

(0.6

)

(0.1

)

Consolidated effective tax rate

 

(28.2

)%

83.8

%

39.8

%

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

For the year ended December 31, 2007, we recorded reserves totaling $425.0 million related to the resolution of the U.S. Attorney’s investigation discussed in Note 15.  However, the tax benefit was not recorded until 2008 when the agreement was reached and the nature of the settlement payments was defined.

 

Deferred income taxes reflect the tax effects of temporary differences between the bases of assets and liabilities recognized for financial reporting purposes and tax purposes, and net operating loss and tax credit carryforwards. Significant components of net deferred tax assets and deferred tax liabilities at December 31:

 



 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

Deferred tax assets:

 

 

 

 

 

Net operating loss carryforwards

 

$

172,962

 

$

158,384

 

Original issue discount

 

97,896

 

109,970

 

Capitalized research and development expenditures

 

6,096

 

11,081

 

Unrealized profit in inventory

 

89,040

 

61,493

 

Research and development tax credits

 

14,912

 

6,208

 

Acquired product rights and intangible assets

 

33,108

 

90,998

 

Reserves and accrued expenses

 

64,256

 

30,005

 

Alternative minimum tax credit carryforwards

 

461

 

13

 

Deferred revenue

 

1,014

 

1,259

 

Deferred compensation

 

8,466

 

8,736

 

SFAS 123(R) stock-based compensation expense

 

22,675

 

15,883

 

Deferred charges on convertible debentures

 

7,323

 

9,431

 

Accounts receivable discounts and allowance

 

39,041

 

28,174

 

Other comprehensive income

 

1,025

 

 

Other, net

 

3,257

 

3,867

 

Total deferred tax assets

 

561,532

 

535,502

 

Valuation allowance

 

(140,448

)

(132,949

)

Net deferred tax assets

 

$

421,084

 

$

402,553

 

 

 

 

 

 

 

Deferred tax liabilities:

 

 

 

 

 

Acquired intangible assets from Group Lafon acquisition

 

$

18,338

 

$

30,319

 

Acquired intangible assets from CIMA LABS acquisition

 

24,344

 

28,250

 

Acquired intangible assets from CTI acquisition

 

12,500

 

14,586

 

Acquired intangible assets from Zeneus acquisition

 

43,450

 

49,034

 

APB 14-1 implementation

 

96,703

 

113,856

 

Deferred revenue

 

91

 

1,816

 

Fixed assets

 

32,609

 

10,704

 

Other comprehensive income

 

 

206

 

Other

 

843

 

158

 

Total deferred tax liabilities

 

$

228,878

 

$

248,929

 

Net deferred tax assets

 

$

192,206

 

$

153,624

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 of the Consolidated Financial Statements for additional information.

 

In accordance with SFAS 109, the above overall net deferred tax assets for the year ended December 31, 2008 and 2007 are presented in the consolidated balance sheet as: current deferred tax assets, net; non-current deferred tax assets, net; and long-term deferred tax liabilities, net.

 

At December 31, 2008, we had gross operating loss carryforwards for U.S. federal income tax purposes of $68.8 million and apportioned state gross operating losses of $645.9 million that expire in varying years starting in 2009. We also have foreign gross operating losses of $427.4 million, of which $105.2 million will begin to expire in 2009 and $322.2 million may be carried forward with indefinite expiration dates. Federal and state research tax credits of $14.9 million are available to offset future tax liabilities and expire starting in 2009. The amount of U.S. federal net operating loss carryforwards that can be utilized in any one period will be limited by federal income tax regulations since a change in ownership as defined in Section 382 of the Internal Revenue Code occurred in the prior years. We do not believe that such limitation will have a material adverse impact on the utilization of the net operating loss carryforwards, but we do believe it will affect utilization of tax credit carryforwards.

 

We believe that all of our domestic federal net operating loss carryforwards, portions of foreign operating loss carryforwards, domestic tax credits and certain other deferred tax assets are not more likely than not to be recovered. The remaining deferred tax assets are offset by a valuation allowance of $140.4 million and $132.9 million at December 31, 2008 and 2007, respectively.  This consists of certain state tax credits, existing and acquired foreign and state operating loss carryforwards that we believe are not more likely than not to be recovered.  A portion of the remaining valuation allowance at December 31, 2008 and December 31, 2007 in the amount of $ 23.1 million and $28.2 million respectively relate to acquired foreign net operating losses for which upon release of the associated valuation allowance a benefit to income may result.  For the year ended December 31, 2008, the increase in valuation allowance of $7.5 million was principally due to an increase of $17.8 million in the company’s U.S. state and foreign net operating losses that are not more likely than not to be recovered, partially offset by decreases of $4.7 million due to currency translation adjustments and $4.4 million due to the release of the valuation allowance to acquired foreign net operating losses, for which a reduction in goodwill was recorded.

 

The tax benefits associated with employee exercises of non-qualified stock options and disqualifying dispositions of stock acquired with incentive stock options reduce taxes payable.  Tax benefits of $7.3 million and $13.6 million associated with the exercise of employee stock options and other equity compensation were recorded to additional paid-in capital for the years ended December 31, 2008 and 2007, respectively.

 



 

Our foreign subsidiaries had no net unremitted earnings at December 31, 2008 and 2007.  To the extent a subsidiary has unremitted earnings, such amounts have been included in the consolidated financial statements without giving effect to deferred taxes since it is management’s intent to reinvest such earnings in foreign operations.

 

The deferred assets and liabilities included within the consolidated results from the activities of the variable interest entity are not realizable benefits and or liabilities to Cephalon.  See Note 2 for additional information.

 

17.  SELECTED CONSOLIDATED QUARTERLY FINANCIAL DATA (UNAUDITED)

 

 

 

2008 Quarter Ended(1), (2)

 

 

 

December 31,

 

September 30,

 

June 30,

 

March 31,

 

Statement of Operations Data:

 

 

 

 

 

 

 

 

 

Net sales

 

$

534,861

 

$

489,664

 

$

485,042

 

$

433,897

 

Gross profit

 

435,338

 

368,187

 

383,724

 

343,981

 

Net Income (loss)

 

(16,042

)

105,598

 

51,891

 

30,442

 

Net income attributable to Cephalon, Inc.

 

$

5,031

 

$

105,598

 

$

51,891

 

$

30,442

 

Basic income per common share attributable to Cephalon, Inc.

 

$

0.07

 

$

1.55

 

$

0.77

 

$

0.45

 

Weighted average number of common shares outstanding

 

68,505

 

68,118

 

67,777

 

67,665

 

Diluted income per common share attributable to Cephalon, Inc

 

$

0.06

 

$

1.34

 

$

0.69

 

$

0.41

 

Weighted average number of common shares outstanding-assuming dilution

 

77,823

 

78,920

 

74,852

 

74,286

 

 

 

 

2007 Quarter Ended(1), (2)

 

 

 

As Adjusted
December 31*,

 

September 30,

 

June 30,

 

March 31,

 

Statement of Operations Data:

 

 

 

 

 

 

 

 

 

Net sales

 

$

439,497

 

$

428,729

 

$

435,194

 

$

423,879

 

Gross profit

 

345,776

 

346,471

 

352,028

 

337,333

 

Net income (loss)

 

$

33,488

 

$

(314,903

)

$

(12,317

)

$

67,304

 

Net income (loss) attributable to Cephalon, Inc.

 

$

33,488

 

$

(314,903

)

$

(12,317

)

$

67,304

 

Basic income (loss) per common share

 

$

0.50

 

$

(4.70

)

$

(0.19

)

$

1.02

 

Weighted average number of common shares outstanding

 

67,187

 

66,931

 

66,445

 

65,806

 

Diluted income (loss) per common share

 

$

0.43

 

$

(4.70

)

$

(0.19

)

$

0.89

 

Weighted average number of common shares outstanding-assuming dilution

 

78,734

 

66,931

 

66,445

 

75,835

 

 

 

 

2008 Quarter Ended

 

Amounts previously reported

 

September 30,

 

June 30,

 

March 31,

 

Net Income (loss):

 

$

112,043

 

$

60,068

 

$

38,851

 

Basic income per common share attributable to Cephalon:

 

1.64

 

.89

 

.57

 

Diluted income per common share attributable to Cephalon:

 

$

1.42

 

$

.80

 

$

.52

 

 

 

 

2007 Quarter Ended

 

Amounts previously reported

 

September 30,

 

June 30,

 

March 31,

 

Net Income (loss):

 

$

(306,763

)

$

(4,308

)

$

75,185

 

Basic income per common share attributable to Cephalon:

 

(4.58

)

(.06

)

1.14

 

Diluted income per common share attributable to Cephalon::

 

$

(4.58

)

$

(.06

)

$

.99

 

 

Difference is due to the adoption of provisions of FSP APB 14-1 on a retrospective basis.  See Note 1 for additional information.

 


*The fourth quarter of 2007 has been adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 for additional information.

(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

 



 

18.  SEGMENT INFORMATION

 

Revenues by segment for the years ended December 31:

 

 

 

2008

 

2007

 

2006

 

 

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

United 
States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

924,986

 

$

63,432

 

$

988,418

 

$

801,639

 

$

50,408

 

$

852,047

 

$

691,779

 

$

43,052

 

$

734,831

 

GABITRIL

 

52,441

 

8,256

 

60,697

 

50,642

 

6,668

 

57,310

 

54,971

 

4,316

 

59,287

 

CNS

 

977,427

 

71,688

 

1,049,115

 

852,281

 

57,076

 

909,357

 

746,750

 

47,368

 

794,118

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

122,980

 

53,541

 

176,521

 

199,407

 

40,665

 

240,072

 

550,390

 

27,252

 

577,642

 

Generic OTFC

 

95,760

 

 

95,760

 

129,033

 

 

129,033

 

54,801

 

 

54,801

 

FENTORA

 

155,246

 

 

155,246

 

135,136

 

 

135,136

 

29,250

 

 

29,250

 

AMRIX

 

73,641

 

 

73,641

 

8,401

 

 

8,401

 

 

 

 

Pain

 

447,627

 

53,541

 

501,168

 

471,977

 

40,665

 

512,642

 

634,441

 

27,252

 

661,693

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TREANDA

 

75,132

 

 

75,132

 

 

 

 

 

 

 

Other Oncology

 

18,566

 

91,919

 

110,485

 

16,561

 

76,316

 

92,877

 

12,617

 

63,425

 

76,042

 

Oncology

 

93,698

 

91,919

 

185,617

 

16,561

 

76,316

 

92,877

 

12,617

 

63,425

 

76,042

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

49,667

 

157,897

 

207,564

 

52,702

 

159,721

 

212,423

 

43,467

 

144,852

 

188,319

 

Total Sales

 

1,568,419

 

375,045

 

1,943,464

 

1,393,521

 

333,778

 

1,727,299

 

1,437,275

 

282,897

 

1,720,172

 

Other Revenues

 

29,546

 

1,544

 

31,090

 

40,149

 

5,190

 

45,339

 

35,399

 

8,498

 

43,897

 

Total External Revenues

 

1,597,965

 

376,589

 

1,974,554

 

1,433,670

 

338,968

 

1,772,638

 

1,472,674

 

291,395

 

1,764,069

 

Inter-Segment Revenues

 

22,397

 

99,686

 

122,083

 

26,092

 

100,992

 

127,084

 

14,806

 

88,879

 

103,685

 

Elimination of Inter-Segment Revenues

 

(22,397

)

(99,686

)

(122,083

)

(26,092

)

(100,992

)

(127,084

)

(14,806

)

(88,879

)

(103,685

)

Total Revenues

 

$

1,597,965

 

$

376,589

 

$

1,974,554

 

$

1,433,670

 

$

338,968

 

$

1,772,638

 

$

1,472,674

 

$

291,395

 

$

1,764,069

 

 

Net income (loss) before income tax by segment for the years ended December 31:

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

As Adjusted
2006(1), (2), (3)

 

United States

 

$

154,897

 

$

(104,413

)

$

249,100

 

Europe

 

(20,827

)

(18,863

)

(56,934

)

Total

 

$

134,070

 

$

(123,276

)

$

192,166

 

 

Long-lived assets by segment at December 31:

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

 

 

United States

 

$

1,309,594

 

$

1,311,570

 

 

 

Europe

 

443,826

 

656,617

 

 

 

Total

 

$

1,753,420

 

$

1,968,187

 

 

 

 

Total assets by segment at December 31:

 

 

 

As Adjusted
2008(1), (2)

 

As Adjusted
2007(1), (2), (3)

 

 

 

United States

 

$

2,293,025

 

$

2,486,790

 

 

 

Europe

 

789,917

 

908,969

 

 

 

Total

 

$

3,082,942

 

$

3,395,759

 

 

 

 


(1)

 

As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).”

(2)

 

As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

(3)

 

As adjusted for the retrospective application of a change in accounting method for inventory. See Note 1 for additional information.

 

Revenues and income (loss) before income taxes are attributed to geographic areas based on customer location. Income (loss) before income taxes exclude inter-segment transactions.

 

19.  SUBSEQUENT EVENTS

 

Ception Therapeutics, Inc.

 

On January 13, 2009, we entered into an option agreement (the “Ception Option Agreement”) with Ception Therapeutics, Inc.  Under the terms of the Ception Option Agreement, we have the irrevocable option (the “Ception Option”) to purchase all of the outstanding capital stock on a fully diluted basis of Ception at any time on or prior to the expiration of the Option Period (as defined below).  As consideration for the Ception Option, we paid $50 million to Ception and also paid certain Ception stockholders an aggregate of $50 million.  We, in our sole discretion, may exercise the Ception Option by

 



 

providing written notice to Ception at any time during the period from January 13, 2009 to and including the date that (i) is fifteen business days after our receipt of the final study report for Ception’s ongoing Phase IIb/III clinical trial for reslizumab in pediatric patients with eosinophilic esophagitis (“Res-5-0002 EE Study”) indicating that the co-primary endpoints have been achieved or (ii) is thirty business days after our receipt of the final study report for Res-5-0002 EE Study indicating that the co-primary endpoints have not been achieved (the “Option Period”).   We anticipate that the Res-5-0002 EE Study will be completed in the fourth quarter of 2009.  If the data are positive and we exercise the Ception Option, we intend to file a Biologics License Application for reslizumab with the FDA in 2010.  If we exercise the Ception Option, we have agreed to pay a total of $250 million in exchange for all the outstanding capital stock of Ception on a fully-diluted basis.  Ception stockholders also could receive (i) additional payments related to clinical and regulatory milestones and (ii) royalties related to net sales of products developed from Ception’s program to discover small molecule, orally-active, anti-TNF (tumor necrosis factor) receptor agents.   In November 2008, we paid a $25 million non-refundable fee to Ception for exclusive rights to negotiate the Ception Option. This payment was credited against the Ception Option Agreement payments.

 

In accordance with FIN 46R, we have determined that effective on January 13, 2009 Ception is a variable interest entity for which we are the primary beneficiary.  As a result, as of January 13, 2009 we will include the financial condition and results of operations of Ception in our consolidated financial statements.

 

LUPUZOR License

 

In November 2008, we entered into an option agreement (the “Immupharma Option Agreement”) with ImmuPharma PLC providing us with an option to obtain an exclusive, worldwide license to the investigational medication LUPUZOR™ for the treatment of systemic lupus erythematosus.  In January 2009, we exercised the option and entered into a Development and Commercialization Agreement (the “Immupharma License Agreement”) with Immupharma based on a review of interim results of a Phase IIb study for LUPUZOR.  Under the terms of the Immupharma Option Agreement, we paid ImmuPharma a $15 million upfront option payment upon execution and will pay a one-time $30 million license fee by early March 2009.  Under the Immupharma License Agreement, Immupharma may receive (i) up to approximately $500 million in milestone payments (including the option and license fees) upon the achievement of regulatory and sales milestones and (ii) royalties on the net sales of LUPUZOR.  We will assume all expenses for the remainder of the term of the Phase IIb study, the Phase III study, regulatory filings and, assuming regulatory approval, subsequent commercialization of the product.

 


EX-99.4 6 a09-13592_2ex99d4.htm EX-99.4

Exhibit 99.4

 

EXHIBIT 12.1

 

Cephalon, Inc.

Computation of Ratios of Earnings to Fixed Charges

(In thousands)

 

 

 

Year Ended December 31,

 

 

 

As
Adjusted
2004(1), (3)

 

As
Adjusted
2005(1), (3)

 

As
Adjusted
2006(1), (3)

 

As
Adjusted
2007(1), (3)

 

As
Adjusted
2008(1), (2)

 

Determination of earnings:

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

$

(33,808

)

$

(264,506

)

$

192,166

 

$

(123,276

)

$

134,070

 

Add:

 

 

 

 

 

 

 

 

 

 

 

Amortization of interest capitalized in current or prior periods

 

 

 

52

 

98

 

250

 

Fixed charges

 

29,918

 

81,007

 

97,054

 

79,993

 

84,762

 

Total earnings

 

$

(3,890

)

$

(183,499

)

$

289,272

 

$

(43,185

)

$

219,082

 

 

 

 

 

 

 

 

 

 

 

 

 

Fixed charges:

 

 

 

 

 

 

 

 

 

 

 

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

 

26,481

 

75,257

 

87,805

 

70,866

 

75,233

 

Appropriate portion of rentals

 

3,437

 

5,750

 

9,249

 

9,127

 

9,529

 

Fixed charges

 

29,918

 

81,007

 

97,054

 

79,993

 

84,762

 

 

 

 

 

 

 

 

 

 

 

 

 

Capitalized interest

 

 

1,044

 

1,766

 

768

 

77

 

 

 

 

 

 

 

 

 

 

 

 

 

Total fixed charges

 

$

29,918

 

$

82,051

 

$

98,820

 

$

80,761

 

$

84,839

 

 

 

 

 

 

 

 

 

 

 

 

 

Ratio of earnings to fixed charges(*)

 

 

 

2.93

 

 

2.58

 

 

 

 

 

 

 

 

 

 

 

 

 

Deficiency of earnings to fixed charges

 

33,808

 

265,550

 

 

123,946

 

 

 


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

 

(1) As adjusted for FASB Staff Position APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement).” See Note 1 of the Consolidated Financial Statements for additional information.

 

(2)  As adjusted for FAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements.”

 

(3)  As adjusted for the retrospective application of a change in accounting method for inventory.  See Note 1 of the Consolidated Financial Statements for additional information.

 


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