-----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, SVkes0iikUHWV861jDNmtFmdsSzVSoNw4J2PCT+dUN5cxMaDYcITGj099AZT0+pF FjCiLQrizrFPAI86MX3HJw== 0001104659-07-081246.txt : 20071108 0001104659-07-081246.hdr.sgml : 20071108 20071108165136 ACCESSION NUMBER: 0001104659-07-081246 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071108 DATE AS OF CHANGE: 20071108 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: 071226527 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 a07-25518_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)       November 8, 2007

 

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 Rd.

 

 

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 2.02      Results of Operations and Financial Condition.

 

The information under this caption is furnished by Cephalon, Inc. (the “Company”) in accordance with Securities Exchange Commission Release No. 33-8216. This information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

On November 8, 2007, the Company issued a press release announcing certain financial results for the third quarter 2007, reiterating full year 2007 total sales guidance and increasing basic adjusted income per common share guidance and introducing sales, adjusted net income and basic adjusted income per share guidance for 2008. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

In the attached press release, the Company discloses “Adjusted net income” “Basic adjusted income per common share,” “Diluted adjusted income per common share” “Basic adjusted income per common share guidance,” and “Adjusted net income guidance” for certain periods, all of which are considered “non-GAAP financial measures” under Securities and Exchange Commission rules. A “non-GAAP financial measure” is defined as a numerical measure of a company’s financial performance, financial position or cash flows that excludes (or includes) amounts that are included in (or excluded from) the most directly comparable measure calculated and presented in accordance with GAAP in the Company’s financial statements. Management does not intend the presentation of non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP.

 

For all periods presented, we reconcile net income (loss) on a GAAP basis to adjusted net income (loss). Management believes that the presentation of these adjusted measures is useful to investors because it provides a means of evaluating the Company’s operating performance and results from period to period on a comparable basis not otherwise apparent on a GAAP basis, since many one-time or infrequent charges, including items that may not affect the Company’s operations, do not meet the strict GAAP definition of unusual non-recurring items. Furthermore, in preparing operating plans, budgets and forecasts, and in assessing historical performance, management relies, in part, on trends in the Company’s historical results, exclusive of these items, and provides its forecasts to investors on this basis. Finally, management believes that this presentation is useful in facilitating comparisons between the Company and other companies in its industry, many of whom exclude similar items.

 

Basic adjusted income (loss) per common share and diluted adjusted income (loss) per common share represent the Company’s adjusted net income (loss), as described above, on a per share basis. Management believes that the presentation of these measures is meaningful because it provides investors with a means of evaluating adjusted net income (loss) against the Company’s previously issued adjusted income per common share guidance. In addition, in assessing the Company’s performance against its previously issued per share guidance, management uses these adjusted per share measures. The presentation of guidance for adjusted net income and basic adjusted net income per common share reconciles the Company’s projected net income and basic income per common share on a GAAP basis to its current quarterly and full-year guidance. Management believes the presentation of these measures is useful to investors because it will enable investors to assess and compare the Company’s guidance on an adjusted and a GAAP basis with adjusted actual results, when issued. Moreover, these measures provide a straightforward view of the Company’s operations free from the complexity associated with determining the daily impact on the income per share calculation resulting from the Company’s outstanding convertible notes. Finally, management utilizes the adjusted net income and basic adjusted income per common share measures in connection with its internal budgeting and forecasting.

 

Item 9.01      Financial Statements and Exhibits.

 

(a)                                  Financial Statements of Business Acquired.

 

None

 

2



 

(b)                                 Pro forma Financial Information.

 

None

 

(c)                                  Exhibits.

 

Exhibit No.

 

Description of Document

99.1

 

Press Release dated November 8, 2007

 

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: November 8, 2007

 

By:

/s/ J. Kevin Buchi

 

 

 

 

J. Kevin Buchi

 

 

 

 

Executive Vice President & Chief Financial

 

 

 

 

Officer

 

 

4



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release dated November 8, 2007

 


EX-99.1 2 a07-25518_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

 

 

 

 

 

News

 

 

 

 

 

Contacts:

 

 

Media:

 

 

Sheryl Williams

 

 

610.738.6493

 

 

swilliam@cephalon.com

 

 

 

 

 

Investors:

 

 

Robert (Chip) Merritt

 

 

610.738.6376

 

 

cmerritt@cephalon.com

 

For immediate release

 

Cephalon Announces Strong Third Quarter Financial Results

 

Company Also Announces Agreement in Principle with U.S. Attorney’s Office;

 

Earnings Exceed Company Guidance;

 

Company Again Increases 2007 Earnings Guidance and

Introduces 2008 Guidance

 

Frazer, Pa. – November 8, 2007 – Cephalon, Inc. (Nasdaq: CEPH) today reported third quarter 2007 sales of $428.7 million, compared to adjusted sales of $457.2 million for the third quarter of 2006 and within the company’s previously issued guidance. Basic loss per common share for the third quarter of 2007 was $4.58. Excluding the settlement reserve increase, amortization expense and certain other items, basic adjusted income per common share during the quarter was $1.08, which compares to $1.71 for the third quarter of 2006 and exceeds the high end of the company’s guidance range of $0.85 to $0.95.

 

During the third quarter, central nervous system (CNS) franchise sales increased 9 percent to $230.9 million and the pain franchise reported strong sales of $121.8 million, a decrease of only 33 percent despite generic competition to ACTIQ®. Sales of other products were $76.0 million, an increase of 20 percent over the same period last year.

 

The company also announced that it has reached an agreement in principle with the U.S. Attorney’s Office in Philadelphia and the U.S. Department of Justice with respect to the previously disclosed investigation of the company’s sales and marketing practices. The company expects to pay $425 million as part of a comprehensive settlement of Federal and related state Medicaid claims. The company has increased its existing financial reserves for this matter accordingly. In addition, the company will agree to a single misdemeanor violation of the

 

SOURCE:  Cephalon, Inc. 41 Moores Road Frazer, PA  19355 (610) 344-0200 Fax (610) 344-0065

 



 

U.S. Food, Drug, and Cosmetic Act and will enter into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The terms of the settlement are subject to the final negotiation and execution of definitive agreements. The previously disclosed investigation by the Connecticut Attorney General is ongoing.

 

“We are pleased with the strong financial performance we delivered in the third quarter of 2007,” said Frank Baldino, Jr., Ph.D., Chairman and CEO. “We also are launching this month our latest product, AMRIX™, a once daily extended release muscle relaxant, and are excited about the continued development of our oncology business with TREANDA®.”

 

Dr. Baldino continued, “We look forward to finalizing our settlement with the U.S. Attorney’s Office. We have always taken seriously our responsibility to conduct our business in accordance with both the letter and spirit of the law. Over the past few years, we have devoted substantial resources to continually enhancing our compliance program and have built a strong foundation for our ongoing compliance efforts.”

 

Based on the strong third quarter financial results announced today, the company is reiterating its guidance for 2007 total sales of $1.675 – $1.725 billion, and increasing its basic adjusted income per common share guidance from $4.40 – $4.50 per share to $4.45 – $4.55 per share.

 

Basic adjusted income per common share guidance for the full-year 2007 and 2008 is reconciled below and is subject to the assumptions set forth therein.

 

Cephalon is introducing 2008 sales guidance of $1.80 – $1.85 billion. This includes CNS franchise sales of $975 – $1,000 million, pain franchise sales of $500 – $525 million, which will include sales of AMRIX™ (cyclobenzaprine hydrochloride extended-release capsules), oncology franchise sales of $110 – $120 million, and other product sales of $190 – $205 million. SG&A and R&D guidance for 2008 are $710 – $730 million and $340 – $360 million, respectively.

 

The company also is introducing adjusted net income guidance for 2008 of $344 – $351 million and 2008 basic adjusted income per common share guidance of $5.10 – $5.20.

 

Cephalon’s management will discuss the company’s third quarter 2007 performance in a conference call with investors beginning at 5:00 p.m. U.S. EST on Thursday, November 8, 2007. To participate in the conference call, dial +1-913-981-5543 and refer to conference code number 6083046. Investors can listen to the call live by logging on to the company’s website at www.cephalon.com and clicking on “Investor Information,” then “Webcast.”  The conference call will be archived and available to investors for one week after the call.

 

About Cephalon, Inc.

 

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered

 

2



 

a seven-year compound annual growth rate (CAGR) through 2006 greater than 75% and 2006 revenue of $1.760 billion.  A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France.

 

The company’s proprietary products in the United States include: PROVIGIL® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide), AMRIX, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

 

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval, including with respect to TREANDA; manufacturing development and capabilities; market prospects for its products, including with respect to AMRIX; sales, adjusted net income and basic adjusted income per common share guidance for 2007 and 2008; and other statements regarding matters that are not historical facts, including the Company’s position and expected performance in 2007 and 2008, the final resolution or outcome of the ongoing investigations by the U.S. Attorney’s Office and the Office of the Connecticut Attorney General and the final amount of any settlement and/or fines related thereto, and the relative strength of the foundation for the Company’s ongoing compliance efforts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

 

This press release and/or the financial results attached to this press release include “Adjusted Net Income,” “Basic Adjusted Income per Common Share,” “Basic Adjusted Income per Common Share Guidance,” and “Diluted Adjusted Income Per Common Share,” amounts that are considered “non-GAAP financial measures” under SEC rules. As required, we have provided reconciliations of these measures. Additional required information is located in the Form 8-K furnished to the SEC in connection with this press release.

 

# # #

 

3



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

REVENUES:

 

 

 

 

 

 

 

 

 

Sales

 

$

428,729

 

$

470,513

 

$

1,287,802

 

$

1,246,825

 

Other revenues

 

9,692

 

11,820

 

34,865

 

32,562

 

 

 

438,421

 

482,333

 

1,322,667

 

1,279,387

 

COSTS AND EXPENSES:

 

 

 

 

 

 

 

 

 

Cost of sales

 

82,258

 

83,160

 

251,970

 

250,613

 

Research and development

 

93,527

 

86,439

 

274,078

 

294,899

 

Selling, general and administrative

 

186,456

 

161,108

 

527,962

 

470,158

 

Settlement reserve

 

369,000

 

 

425,000

 

 

Impairment charge

 

 

 

 

12,417

 

 

 

731,241

 

330,707

 

1,479,010

 

1,028,087

 

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) FROM OPERATIONS

 

(292,820

)

151,626

 

(156,343

)

251,300

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

 

 

 

 

 

 

Interest income

 

8,868

 

7,046

 

23,485

 

16,736

 

Interest expense

 

(5,660

)

(4,749

)

(15,272

)

(13,523

)

Write-off of deferred debt issuance costs

 

 

 

 

(13,105

)

Gain on extinguishment of debt

 

5,319

 

 

5,319

 

 

Gain on sale of investment

 

 

 

5,791

 

 

Other income (expense), net

 

2,493

 

895

 

3,747

 

(116

)

 

 

11,020

 

3,192

 

23,070

 

(10,008

)

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) BEFORE INCOME TAXES

 

(281,800

)

154,818

 

(133,273

)

241,292

 

 

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE

 

24,963

 

59,077

 

102,613

 

91,567

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS)

 

$

(306,763

)

$

95,741

 

$

(235,886

)

$

149,725

 

 

 

 

 

 

 

 

 

 

 

BASIC INCOME (LOSS) PER COMMON SHARE

 

$

(4.58

)

$

1.58

 

$

(3.55

)

$

2.48

 

 

 

 

 

 

 

 

 

 

 

DILUTED INCOME (LOSS) PER COMMON SHARE

 

$

(4.58

)

$

1.43

 

$

(3.55

)

$

2.17

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

66,931

 

60,762

 

66,398

 

60,415

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION

 

66,931

 

67,072

 

66,398

 

68,921

 

 


Certain reclassifications of prior year amounts have been made to conform to the current year presentation. Amounts reported in prior periods as amortization are included now as a component of cost of sales; amounts previously reported as depreciation (other than depreciation related to facilities used in the production of commercial inventory and previously included in cost of sales) are included as a component of research and development or selling, general and administrative, as appropriate.

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(Unaudited)

 

 

 

Three Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

 

 

 

 

 

 

GAAP NET INCOME (LOSS)

 

$

(306,763

)

$

95,741

 

 

 

 

 

 

 

Sales adjustments

 

 

(13,273

)(6)

Cost of sales adjustments

 

22,255

(1)

20,804

(1)

Research and development adjustments

 

15,000

(2)

(8)

Selling, general and administrative adjustments

 

 

2,000

(7)(8)

Settlement reserve

 

369,000

(3)

 

Gain on extinguishment of debt

 

(5,319

)(4)

 

Income taxes

 

(21,693

)(5)

(1,278

)(5)(8)

 

 

379,243

 

8,253

 

 

 

 

 

 

 

ADJUSTED NET INCOME

 

$

72,480

 

$

103,994

 

 

 

 

 

 

 

BASIC ADJUSTED INCOME PER COMMON SHARE

 

$

1.08

 

$

1.71

 

 

 

 

 

 

 

DILUTED ADJUSTED INCOME PER COMMON SHARE

 

$

0.92

 

$

1.55

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

66,931

 

60,762

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION

 

79,030

 

67,072

 

 

Notes to Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

 


(1)

 

To exclude the on-going amortization of acquired intangible assets.

 

 

 

(2)

 

To exclude the recognition of a milestone related to the FDA’s acceptance of our NDA filing for TREANDA® (bendamustine HCl).

 

 

 

(3)

 

To exclude the additional reserve established for the agreement in principle reached with the U.S. Attorney’s Office in Philadelphia.

 

 

 

(4)

 

To exclude the forgiveness of a mortgage loan by the Pennsylvania Industrial Development Board (“PIDA”).

 

 

 

(5)

 

To reflect the tax effect of pre-tax adjustments at the applicable tax rates and certain other tax adjustments primarily related to changes in valuation allowances and other changes in tax assets and liabilities.

 

 

 

(6)

 

To exclude the U.S. Department of Defense (“DoD”) Tricare program reversal as a result of the U.S. Court of Appeals September 2006 ruling.

 

 

 

(7)

 

To exclude charges associated with the settlement of the PROVIGIL patent litigation.

 

 

 

(8)

 

Amounts shown no longer exclude the impact of Financial Accounting Standards Board Statement No. 123(R) “Share Based Payment” (“SFAS 123(R)”). The earnings press release issued on November 2, 2006 reflected adjustments of $3.4 million in each of Research and development and Selling, general and administrative expenses and $2.8 million in Income tax expense related to SFAS 123(R).

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(Unaudited)

 

 

 

Nine Months Ended
September 30,

 

 

 

2007

 

2006

 

 

 

 

 

 

 

GAAP NET INCOME (LOSS)

 

$

(235,886

)

$

149,725

 

 

 

 

 

 

 

Sales adjustments

 

 

(13,273

)(7)

Cost of sales adjustments

 

64,236

(1)

69,375

(1)

Research and development adjustments

 

41,500

(2)

45,000

(2)(11)

Selling, general and administrative adjustments

 

 

9,987

(8)(11)

Settlement reserve

 

425,000

(3)

 

Impairment charge

 

 

12,417

(9)

Write-off of deferred debt issuance costs

 

 

13,105

(10)

Gain on extinguishment of debt

 

(5,319

)(4)

 

Gain on sale of investment

 

(5,791

)(5)

 

Income taxes

 

(40,459

)(6)

(44,060

)(6)(11)

 

 

479,167

 

92,551

 

 

 

 

 

 

 

ADJUSTED NET INCOME

 

$

243,281

 

$

242,276

 

 

 

 

 

 

 

BASIC ADJUSTED INCOME PER COMMON SHARE

 

$

3.66

 

$

4.01

 

 

 

 

 

 

 

DILUTED ADJUSTED INCOME PER COMMON SHARE

 

$

3.09

 

$

3.52

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

66,398

 

60,415

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION

 

78,814

 

68,921

 

 



 

Notes to Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

 


(1)

 

In 2007, to exclude the on-going amortization of acquired intangible assets. In 2006, to exclude the reserve for SPARLON capitalized inventory costs ($8.6 million) and the on-going amortization of acquired intangible assets ($60.8 million).

 

 

 

(2)

 

In 2007, to exclude charges related to payments for several research and development collaborations ($26.5 million) and the recognition of a milestone related to the FDA’s acceptance of our NDA filing for TREANDA ($15.0 million). In 2006, to exclude charges related to payments for several research and development collaborations.

 

 

 

(3)

 

To exclude the reserve established for the agreement in principle reached with the U.S. Attorney’s Office in Philadelphia.

 

 

 

(4)

 

To exclude the forgiveness of a mortgage loan by the PIDA.

 

 

 

(5)

 

To exclude the pre-tax gain related to the sale of certain investments.

 

 

 

(6)

 

To reflect the tax effect of pre-tax adjustments at the applicable tax rates and certain other tax adjustments primarily related to changes in valuation allowances and other changes in tax assets and liabilities.

 

 

 

(7)

 

To exclude the DoD Tricare program reversal as a result of the U.S. Court of Appeals September 2006 ruling.

 

 

 

(8)

 

To exclude charges associated with the settlement of the PROVIGIL patent litigation ($6.0 million) and employee severance costs associated with the European integration and restructuring ($4.0 million).

 

 

 

(9)

 

To exclude charges related to the impairment of an intangible asset.

 

 

 

(10)

 

To exclude the write-off of deferred debt issuance costs related to the Zero Coupon convertible subordinated notes.

 

 

 

(11)

 

Amounts shown no longer exclude the impact of SFAS 123(R). The earnings press release issued on November 2, 2006 reflected adjustments of $11.6 million in each of Research and development and Selling, general and administrative expenses and $8.8 million in Income tax expense related to SFAS 123(R).

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

“ADJUSTED” CONSOLIDATED SALES DETAIL  *

(In thousands)

(Unaudited)

 

 

 

Three Months Ended

 

%

 

 

 

September 30,

 

Increase

 

 

 

2007

 

2006

 

(Decrease)

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

202,202

 

$

14,904

 

$

217,106

 

$

186,568

 

$

11,081

 

$

197,649

 

8

%

35

%

10

%

GABITRIL

 

12,952

 

881

 

13,833

 

13,729

 

723

 

14,452

 

(6

)%

22

%

(4

)%

CNS

 

215,154

 

15,785

 

230,939

 

200,297

 

11,804

 

212,101

 

7

%

34

%

9

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

45,946

 

10,007

 

55,953

 

174,147

 

7,585

 

181,732

 

(74

)%

32

%

(69

)%

Generic OTFC

 

32,689

 

 

32,689

 

 

 

 

100

%

0

%

100

%

FENTORA

 

33,193

 

 

33,193

 

 

 

 

100

%

0

%

100

%

Pain

 

111,828

 

10,007

 

121,835

 

174,147

 

7,585

 

181,732

 

(36

)%

32

%

(33

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

19,291

 

56,664

 

75,955

 

13,292

 

50,115

 

63,407

 

45

%

13

%

20

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

346,273

 

$

82,456

 

$

428,729

 

$

387,736

 

$

69,504

 

$

457,240

 

(11

)%

19

%

(6

)%

 

 

 

Nine Months Ended

 

%

 

 

 

September 30,

 

Increase

 

 

 

2007

 

2006

 

(Decrease)

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

593,394

 

$

39,171

 

$

632,565

 

$

494,047

 

$

29,219

 

$

523,266

 

20

%

34

%

21

%

GABITRIL

 

39,814

 

6,268

 

46,082

 

41,291

 

3,510

 

44,801

 

(4

)%

79

%

3

%

CNS

 

633,208

 

45,439

 

678,647

 

535,338

 

32,729

 

568,067

 

18

%

39

%

19

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTIQ

 

157,097

 

28,638

 

185,735

 

452,175

 

19,213

 

471,388

 

(65

)%

49

%

(61

)%

Generic OTFC

 

97,562

 

 

97,562

 

 

 

 

100

%

0

%

100

%

FENTORA

 

101,224

 

 

101,224

 

 

 

 

100

%

0

%

100

%

Pain

 

355,883

 

28,638

 

384,521

 

452,175

 

19,213

 

471,388

 

(21

)%

49

%

(18

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

53,867

 

170,767

 

224,634

 

41,661

 

152,436

 

194,097

 

29

%

12

%

16

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

1,042,958

 

$

244,844

 

$

1,287,802

 

$

1,029,174

 

$

204,378

 

$

1,233,552

 

1

%

20

%

4

%

 


*

 

For both the three and nine months ended September 30, 2006, amounts exclude the impact of the DoD Tricare program reversal of $13.3 million which reduced GAAP U.S. sales of PROVIGIL, GABITRIL and ACTIQ by $6.9 million, $0.9 million and $5.5 million, respectively.

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

661,982

 

$

496,512

 

Investments

 

69,101

 

25,212

 

Receivables, net

 

302,748

 

270,045

 

Inventory, net

 

93,399

 

85,239

 

Deferred tax assets, net

 

204,140

 

184,518

 

Other current assets

 

34,626

 

47,278

 

Total current assets

 

1,365,996

 

1,108,804

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, net

 

481,508

 

453,010

 

GOODWILL

 

476,605

 

467,167

 

INTANGIBLE ASSETS, net

 

839,255

 

793,037

 

DEFERRED TAX ASSETS, net

 

103,284

 

118,192

 

OTHER ASSETS

 

132,056

 

105,287

 

 

 

$

3,398,704

 

$

3,045,497

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Current portion of long-term debt

 

$

1,237,285

 

$

1,023,312

 

Accounts payable

 

74,528

 

90,586

 

Accrued expenses

 

685,864

 

263,478

 

Total current liabilities

 

1,997,677

 

1,377,376

 

 

 

 

 

 

 

LONG-TERM DEBT

 

4,373

 

224,992

 

DEFERRED TAX LIABILITIES, net

 

66,864

 

72,491

 

OTHER LIABILITIES

 

103,982

 

61,178

 

Total liabilities

 

2,172,896

 

1,736,037

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value

 

693

 

678

 

Additional paid-in capital

 

1,899,761

 

1,780,749

 

Treasury stock, at cost

 

(151,196

)

(151,068

)

Accumulated deficit

 

(668,310

)

(425,256

)

Accumulated other comprehensive income

 

144,860

 

104,357

 

Total stockholders’ equity

 

1,225,808

 

1,309,460

 

 

 

$

3,398,704

 

$

3,045,497

 

 


Certain reclassifications of prior year amounts have been made to conform to the current year presentation.  The NUVIGIL® (armodafinil) [C-IV] inventory balance of $89.1 million as of December 31, 2006 has been reclassified from inventory to other assets, as we do not presently intend to launch NUVIGIL commercially until around 2010.

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net income (loss)

 

$

(235,886

)

$

149,725

 

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

 

 

 

 

 

Deferred income tax expense

 

8,750

 

64,112

 

Shortfall tax benefits from stock-based compensation

 

(222

)

 

Depreciation and amortization

 

101,206

 

94,828

 

Amortization of debt issuance costs

 

180

 

387

 

Write-off of debt issuance costs associated with convertible subordinated notes

 

 

13,105

 

Stock-based compensation expense

 

34,940

 

32,436

 

Gain on extinguishment of debt

 

(5,319

)

 

Gain on sale of investment

 

(5,791

)

 

Loss on disposals of property and equipment

 

2,873

 

2,368

 

Impairment charge

 

 

12,417

 

Changes in operating assets and liabilities:

 

 

 

 

 

Receivables

 

(26,218

)

(30,818

)

Inventory

 

(1,881

)

15,761

 

Other assets

 

(28,552

)

(43,731

)

Accounts payable and accrued expenses

 

380,776

 

(45,820

)

Other liabilities

 

49,465

 

(13,580

)

Net cash provided by operating activities

 

274,321

 

251,190

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property and equipment

 

(70,887

)

(97,122

)

Acquisition of intangible assets

 

(99,152

)

(115,000

)

Proceeds from sale of investment

 

12,291

 

 

Sales and (purchases) of available-for-sale investments, net

 

(43,186

)

242,660

 

Net cash provided by (used for) investing activities

 

(200,934

)

30,538

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from exercises of common stock options

 

74,375

 

112,794

 

Windfall tax benefits from stock-based compensation

 

9,934

 

21,912

 

Acquisition of treasury stock

 

(128

)

(433

)

Payments on and retirements of long-term debt

 

(2,902

)

(2,528

)

Net cash provided by financing activities

 

81,279

 

131,745

 

 

 

 

 

 

 

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

 

10,804

 

11,830

 

 

 

 

 

 

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

165,470

 

425,303

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

496,512

 

205,060

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

661,982

 

$

630,363

 

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

Reconciliation of Projected GAAP Basic Income (Loss) per Common Share

to Basic Adjusted Income Per Common Share Guidance

(Unaudited)

 

 

 

Twelve Months Ended

 

Twelve Months Ended

 

 

 

December 31, 2007

 

December 31, 2008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Projected GAAP basic income (loss) per common share

 

$

(3.08

)

 

$

(2.98

)

$

4.13

 

 

$

4.23

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of current intangibles

 

$

1.35

 

 

$

1.35

 

$

1.52

 

 

$

1.52

 

Research and development adjustments

 

$

0.62

 

 

$

0.62

 

$

 

 

$

 

Settlement reserve

 

$

6.38

 

 

$

6.38

 

$

 

 

$

 

Gain on extinguishment of debt

 

$

(0.08

)

 

$

(0.08

)

$

 

 

$

 

Gain on sale of investment

 

$

(0.09

)

 

$

(0.09

)

$

 

 

$

 

Tax effect of pre-tax adjustments at the applicable tax rates *

 

$

(0.65

)

 

$

(0.65

)

$

(0.55

)

 

$

(0.55

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic adjusted income per common share guidance

 

$

4.45

 

 

$

4.55

 

$

5.10

 

 

$

5.20

 

 


* For the twelve months ended December 31, 2007, we have not yet recognized a tax benefit for the settlement reserve due to the uncertainty associated with the tax treatment of any potential settlement.

 

The company’s 2007 guidance is being issued based on certain assumptions including:

 

 

Adjusted effective tax rate of approximately 36 to 37 percent; and

 

Weighted average number of common shares outstanding of 66.6 million shares for the twelve months ended December 31, 2007.

 

The company’s 2008 guidance is being issued based on certain assumptions including:

 

 

Entrance into the market of an additional generic version of ACTIQ by mid-2008;

 

Approval of TREANDA and mid-2008 launch;

 

Reduction of interest income by $20 million resulting from payment of the settlement with the U.S. Attorney’s Office;

 

Adjusted effective tax rate of approximately 36 to 37 percent; and

 

Weighted average number of common shares outstanding of 67.5 million shares for the twelve months ended December 31, 2008.

 


GRAPHIC 3 g255182mmi001.jpg GRAPHIC begin 644 g255182mmi001.jpg M_]C_X``02D9)1@`!`0$`8`!@``#_VP!#``H'!P@'!@H("`@+"@H+#A@0#@T- M#AT5%A$8(Q\E)"(?(B$F*S7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBI MJK*SM+6VM[BYNL+#Q,7&Q\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W M^/GZ_]H`"`$!```_`/+=,76-8U6#3;*YN)+BYD$<:^:W4]S[#J:^BO#7A+2/ M`NDF\O;OS;B--UQ?W4G"^H7/W1^IJ$?%SP2;O[/_`&N1SCS#`^S\\4_Q3X,T MOQMI?VVPN_(NY$W6][;2';)QP&QPP]^HKYVO&U;3=3EL;RXN8Y[>4QR(96X( M/UKZKTVZWPQQ2'Y@@P?7BK]>7?&;QI?Z!;6NCZ7.UO/>*9)9D.'6,'`"GMDY MY]JX.+X6>+;C01XD6XB,CQ?:%B,S>>5QG.<=<F7^K:=I48DU"_M[13T,\JIGZ9-.L=3L-3A\[3[V M"[C'!:"0.!^5%UJ5A9.J7=[;V[,,JLLJH2/;)J*\UW2-.G2"]U2SMI9/N)+. MJLWX$U0\;R,G@769(G*L+*0JRG!'R]0:X#X&:BYTK7)[^]8QQ21$R3R\(,-W M)XKU'3]7TW5D9].O[:\5#AC!*K[?K@\5-:W\"+)!-)$_VR,;D8J<8;TJQ\'IYKCX M>VLD\KRN9IRMI?[DMPJM^1-7;>ZM[R!9[:>. M>)ONR1N&4_0BH?[4T\77V0W]M]HSM\GSEWY]-N,+V[D4%[6U/EY[%F`S^61^-7?CSK=T=3L=#1V M2U6'[1(H/$CDD#/K@#]:\CKL_!OQ-U?P98RV-O##=VTC[T2(Y/%?B`ZO-9PVLLH176'.&(XSSWQC\J^D8B1'&0<$*N#^%;-I,9X`[#D'!K MPGX]?\C?8_\`7B/_`$-Z]JT%%D\,::C@,K640(/<;!5;3?"?AWP].]]IFDP6 MLPC*EXPI'Z"O!]&CA^(_C>ZN?$VLBRM]K2[GE5,+D!8T+<#K^AIT[1_#O MXC6__"/:M]MLR8V9ED#!T8X9&*\'O^E;OQ]./$.E$=K5O_0S3?'7P[M--\#Q M>)OM]W=:DYBDN9)W!$F_'0=L$C'M6YX6U2XU/X"ZLMQ(TC6D%Q`K,.O`OB[QGXO3?)'#HD3JD7[X'8O&Y]G=NOZ5P_Q"\)V M'@34]/DT/5I996W,P,B^9"ZXP?EQC.?T-=[\4[R34/A#IM[-_K+A[:5\>K(2 M:@\):K<:)\`[K4+5MD\7G"-O[K%]H/X9S7*?#[X;Q>/-/O=5U#5)XF2O45=^%%W>>'OB3=>&6N6EMG::%U!.TO'DAP.Q^4C\:R_$-K-M>TC9TR?F)0$\=.371445\U?"CQ'%X>\;Q_:G"6U\IMI&/ M122"I/X@#\:]2^*WP_G\76D-_IFTZC9J5$;'`F0G.,]B#R/J:\2'@CQ2UY]D M'A_4/.SC'D-C\^F/?->P^!?A'IVG:.TOB>QAN[ZQ_WC7B'Q\B= M?%6G2D?(]EM!]2';/\Q7K.E:Q9P>`+35!=1""'3T8REA@%4''UR,8K@OAIX\ M\3>+M:O;34I8I;:*R=R$A"G=D`.0E0?'[_D8-*_Z]&_]#-= M=\3'5?@ZH)&7CM@ONKAX MR'7[9=MD'(QA^:CO/^3A%_["D?\`(5H_M`?\A?1_^N$G_H0KV#P[_P`BUI?_ M`%YP_P#H`K1HHKYGO_AGJNG7LEMH03Q7,*30NLD;C*LIR"*\V^(VI>)[II=%LGATVT M./!-EXVTI+:>0V]Q`Q:WN%7)0GJ".X/''L*\N/P(\1;_`"1K M-C]GSG.7_/;C&?QKTWP)X$LO!&GRQ13&YN[@@SW#+MSCH`.P&37)>(_@Y=2: M])K/A;5ETZ61S(8F+)L8]=K+R`?3%.\+_!ZZM?$$6M^)=674)XG$@C7<^]QT M+,W)QZ8[5S_Q^_YO^O1O_`$,U>OOA)XAU;3;&"T\3M+I9C21+:\=SY!*] M@,@XR<=*[VV\$QZ?\.Y_"ME.-\ML\9G=>&=\Y8@=LG\JI_#;P+=>![:_BNKV M&Z-VZ,IB4C;M!ZY^M9?A[X7WVB_$%_$TFHV\L+332>2J,&PX;`STXW5G^)OA M#JUWXLFU[P_K$-H\\WG8I5E!R,Y].M0:M\$]5U2*&XN?$S7>HDGSYK MD,R[>-H7DGCG\ZZSQ+X'O->\`6'AN.\ABGM1"&F925;8NTX'7FK/A7P6NC^! MF\,:I)'>1R^8)#&"`5U=OIEJUCI5I9NP=K>!( MBPZ$JH&?TJU24M96NZ%!K=GL?"3H"8I/[I]#[5YG>6L]A=/;72>7*AP0?YCU M%;'AGQ*=(F%OU6=(U=M,NTP[]V3G/45VME;_9+&WMMV[R8ECW8Q MG`QFIZ2EK)USQ'IF@V[F[O;:*Y,3R0P2RA&E*@G`SZXQ4<7BC2H].TVXU*]M MK&74(4DCBEE`.6`.!GKR<9JO=^)98=2U.RCM[?-A]EP\]QY:OYS$'G'!&.!W M)Q6L=5TY;:6Y-[`(89#%)(7&$<':5)[')`Q3(]/ MPIUIK&F7\[06=_;SRHNYDCD#%1DKD@=.01^%0W7B/1+&Z^RW>JV<$_F"/RY) ME#;B`0,?0C\Z?::]I%^+DVFIVLXM/]>4E4B+_>/8<'FF6WB31+RQEOK;5;26 MU@(665)050GID]J2X\3Z#:V\=S/K%E'#-(T<<'@^E9OBJZT^ MV-M`JC`%1S65K<.'GMHI6`P"Z`G'XU'_96G?\^%M_WZ7_"G?V?9>6L?V2'8 MIR%\L8!]<59HHHHHHHHHKS7Q/=6VB^)=>34[0W#:[8I%IS!5;+*C*T?)^7YB M&R>/QK#U+RM,>%M7O;N"UU;1+6VMUMHHI#,53#Q'>#MY8$'@<]>*UM6M)(?[ M;AVR$HFCK^\8%OEDYR1P3ZU>O;"X_P"%BIHD:`:?>W,>LRG(QNC4J5Q[NL;5 MC:#%''XDM-`O[[4)-5L]4DNC;1I$(P"S-YID(W$%6Y&<\XQQ77_#JPM[;P]) M<);QQSSWERTL@`W/^^8#)^@%<]X@LUEA^(+M`C.PMPK$#./*7C/UJ7Q5I4EQ MJNL6UC;)C^Q+=O*3"!U2G*@C\:R-9N[3Q1I_B+6]&MS'IITV"S?*A#+* M)@Q^7_94XS[\5H>,K>S\.>(K>YN)YM.TB;3?L4`LX(Y,,&):/:P.`P(Y'IR: ?ZG2[BVT+1=&M3:3E_LR11F4HTB#@!68<>G3BNEK_V3\_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----