UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q

(Mark one)

x

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

For the quarterly period ended September 30, 2005

OR

o

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

 

For the transition period from                      to                     

Commission File Number: 0-12798


CHIRON CORPORATION

(Exact name of registrant as specified in its charter)

Delaware

 

94-2754624

(State or other jurisdiction of
incorporation or organization)

 

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

4560 Horton Street, Emeryville, California

 

94608

(Address of principal executive offices)

 

(Zip code)

 

(510) 655-8730

(Registrant’s telephone number, including area code)

Not Applicable

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


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes x    No o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes x    No o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o    No x

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

Title of Class

 

Outstanding at October 31, 2005

Common Stock, $0.01 par value

 

188,575,753

 

 




CHIRON CORPORATION
TABLE OF CONTENTS

 

Page No.

PART I.   FINANCIAL INFORMATION

 

 

 

 

ITEM 1.   Financial Statements (Unaudited)

 

 

 

 

Condensed Consolidated Balance Sheets at September 30, 2005 and December 31, 2004

 

 

3

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2005 and 2004

 

 

5

 

Condensed Consolidated Statements of Comprehensive Income (loss) for the three and nine months ended September 30, 2005 and 2004

 

 

6

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2005 and 2004

 

 

7

 

Notes to Condensed Consolidated Financial Statements

 

 

8

 

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

 

 

23

 

ITEM 3.   Quantitative and Qualitative Disclosures About Market Risk

 

 

60

 

ITEM 4.   Controls and Procedures

 

 

61

 

PART II.   OTHER INFORMATION

 

 

 

 

ITEM 1.   Legal Proceedings

 

 

63

 

ITEM 2.   Unregistered Sales of Equity Securities and Use of Proceeds

 

 

65

 

ITEM 3.   Defaults Upon Senior Securities

 

 

65

 

ITEM 4.   Submission of Matters to a Vote of Security Holders

 

 

65

 

ITEM 5.   Other Information

 

 

65

 

ITEM 6.   Exhibits

 

 

66

 

SIGNATURES

 

 

68

 

 

2




Item 1.                        Financial Statements

CHIRON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share data)

 

 

September 30,
2005

 

December 31,
2004

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

$

204,368

 

 

 

$

209,509

 

 

Short-term investments in marketable debt securities

 

 

375,738

 

 

 

394,112

 

 

Total cash, cash equivalents and short-term investments

 

 

580,106

 

 

 

603,621

 

 

Accounts receivable, net of allowances

 

 

383,925

 

 

 

402,094

 

 

Inventories, net of reserves

 

 

268,566

 

 

 

221,154

 

 

Assets held for sale

 

 

1,221

 

 

 

 

 

Current net deferred income tax asset

 

 

61,398

 

 

 

71,287

 

 

Derivative financial instruments

 

 

5,418

 

 

 

4,969

 

 

Other current assets

 

 

141,488

 

 

 

90,898

 

 

Total current assets

 

 

1,442,122

 

 

 

1,394,023

 

 

Non-current investments in marketable debt securities

 

 

437,650

 

 

 

409,421

 

 

Property, plant, equipment and leasehold improvements, at cost:

 

 

 

 

 

 

 

 

 

Land and buildings

 

 

379,799

 

 

 

379,861

 

 

Laboratory, production and office equipment

 

 

674,094

 

 

 

637,394

 

 

Leasehold improvements

 

 

137,099

 

 

 

125,858

 

 

Construction-in-progress

 

 

247,349

 

 

 

225,482

 

 

 

 

 

1,438,341

 

 

 

1,368,595

 

 

Less accumulated depreciation and amortization

 

 

(614,244

)

 

 

(569,180

)

 

Property, plant, equipment and leasehold improvements, net

 

 

824,097

 

 

 

799,415

 

 

Purchased technologies, net

 

 

200,830

 

 

 

216,037

 

 

Goodwill

 

 

805,948

 

 

 

861,394

 

 

Other intangible assets, net

 

 

375,994

 

 

 

457,707

 

 

Investments in equity securities and affiliated companies

 

 

64,812

 

 

 

100,951

 

 

Non-current notes receivable

 

 

12,467

 

 

 

7,500

 

 

Other non-current assets

 

 

52,886

 

 

 

59,055

 

 

 

 

 

$

4,216,806

 

 

 

$

4,305,503

 

 

 

The accompanying Notes to Condensed Consolidated Financial Statements are integral to this statement.

3




CHIRON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (Continued)
(Unaudited)
(In thousands, except share data)

 

 

September 30,
2005

 

December 31,
2004

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

Accounts payable

 

 

$

124,612

 

 

 

$

129,942

 

 

Accrued compensation and related expenses

 

 

80,634

 

 

 

79,113

 

 

Derivative financial instruments

 

 

 

 

 

10,395

 

 

Current portion of long-term debt and capital lease

 

 

1,569

 

 

 

2,687

 

 

Current portion of unearned revenue

 

 

54,454

 

 

 

35,651

 

 

Income taxes payable

 

 

18,051

 

 

 

16,363

 

 

Other current liabilities

 

 

180,202

 

 

 

160,293

 

 

Total current liabilities

 

 

459,522

 

 

 

434,444

 

 

Long-term debt

 

 

938,449

 

 

 

936,652

 

 

Long-term portion of capital lease

 

 

156,723

 

 

 

156,952

 

 

Non-current derivative financial instruments

 

 

 

 

 

156

 

 

Non-current net deferred income tax liability

 

 

37,063

 

 

 

60,427

 

 

Non-current unearned revenue

 

 

25,146

 

 

 

26,175

 

 

Other non-current liabilities

 

 

68,549

 

 

 

79,643

 

 

Minority interest

 

 

10,679

 

 

 

9,350

 

 

Total liabilities

 

 

1,696,131

 

 

 

1,703,799

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

Common stock

 

 

1,917

 

 

 

1,917

 

 

Additional paid-in capital

 

 

2,539,628

 

 

 

2,527,709

 

 

Deferred stock compensation

 

 

(15,988

)

 

 

(13,825

)

 

Accumulated deficit

 

 

(14,920

)

 

 

(11,843

)

 

Accumulated other comprehensive income

 

 

158,809

 

 

 

330,491

 

 

Treasury stock, at cost (3,156,000 shares at September 30, 2005 and 4,804,000 shares at December 31, 2004)

 

 

(148,771

)

 

 

(232,745

)

 

Total stockholders’ equity

 

 

2,520,675

 

 

 

2,601,704

 

 

 

 

 

$

4,216,806

 

 

 

$

4,305,503

 

 

 

The accompanying Notes to Condensed Consolidated Financial Statements are integral to this statement.

4




CHIRON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

367,175

 

$

375,549

 

$

947,913

 

$

937,836

 

Revenues from joint business arrangement

 

36,093

 

34,017

 

103,154

 

92,910

 

Collaborative agreement revenues

 

3,149

 

4,124

 

11,129

 

14,467

 

Royalty and license fee revenues

 

70,726

 

111,396

 

227,309

 

221,384

 

Other revenues

 

2,470

 

4,450

 

16,221

 

22,363

 

Total revenues

 

479,613

 

529,536

 

1,305,726

 

1,288,960

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of sales (excludes amortization expense related to acquired developed products)

 

168,726

 

241,044

 

511,005

 

498,808

 

Research and development

 

107,309

 

103,000

 

324,620

 

301,736

 

Selling, general and administrative

 

117,152

 

112,013

 

375,802

 

321,775

 

Amortization expense of intangible assets acquired in business combinations and asset purchases

 

12,361

 

20,566

 

54,237

 

63,077

 

Purchased in-process research and development

 

 

9,629

 

 

9,629

 

Impairment loss on acquired intangible assets

 

14,522

 

 

14,522

 

 

Other operating expenses

 

3,621

 

1,280

 

12,823

 

8,040

 

Total operating expenses

 

423,691

 

487,532

 

1,293,009

 

1,203,065

 

Income from operations

 

55,922

 

42,004

 

12,717

 

85,895

 

Interest expense

 

(7,759

)

(7,063

)

(22,932

)

(19,440

)

Interest and other income, net

 

18,514

 

5,369

 

66,259

 

41,252

 

Minority interest

 

(531

)

(504

)

(1,723

)

(1,583

)

Income from continuing operations before income taxes

 

66,146

 

39,806

 

54,321

 

106,124

 

Provision for income taxes

 

14,835

 

12,359

 

11,903

 

28,938

 

Income from continuing operations

 

51,311

 

27,447

 

42,418

 

77,186

 

Gain (loss) from discontinued operations, net of taxes

 

 

(450

)

 

24,854

 

Net income

 

$

51,311

 

$

26,997

 

$

42,418

 

$

102,040

 

Basic earnings per share:

 

 

 

 

 

 

 

 

 

Income from continuing operations

 

$

0.27

 

$

0.15

 

$

0.23

 

$

0.41

 

Net income

 

$

0.27

 

$

0.14

 

$

0.23

 

$

0.54

 

Diluted earnings per share:

 

 

 

 

 

 

 

 

 

Income from continuing operations

 

$

0.27

 

$

0.14

 

$

0.22

 

$

0.40

 

Net income

 

$

0.27

 

$

0.14

 

$

0.22

 

$

0.53

 

 

The accompanying Notes to Condensed Consolidated Financial Statements are integral to this statement.

5




CHIRON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(In thousands)

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

Net income

 

$

51,311

 

$

26,997

 

$

42,418

 

$

102,040

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

Change in foreign currency translation adjustment during the period

 

(27,980

)

2,960

 

(152,119

)

(34,452

)

Unrealized gains (losses) from investments:

 

 

 

 

 

 

 

 

 

Net unrealized holding gains (losses) arising during the period, net of tax (provision) benefit of ($3,098) and ($5,977) for the three months ended September 30, 2005 and 2004, respectively, and ($1,419) and ($3,865) for the nine months ended September 30, 2005 and 2004, respectively

 

5,013

 

(2,680

)

2,564

 

4,864

 

Reclassification adjustment for net gains included in net income, net of tax (provision) of ($2,773) and ($400) for the three months ended September 30, 2005 and 2004, respectively, and ($13,682) and ($9,753) for the nine months ended September 30, 2005 and 2004, respectively

 

(4,472

)

(625

)

(22,127

)

(15,254

)

Net unrealized gains (losses) from investments

 

541

 

(3,305

)

(19,563

)

(10,390

)

Other comprehensive loss

 

(27,439

)

(345

)

(171,682

)

(44,842

)

Comprehensive income (loss)

 

$

23,872

 

$

26,652

 

$

(129,264

)

$

57,198

 

 

The accompanying Notes to Condensed Consolidated Financial Statements are integral to this statement.

6




CHIRON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)

 

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

 

 

 

 

Restated

 

Net cash provided by operating activities

 

$

117,561

 

$

132,633

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of investments in marketable debt securities

 

(714,151

)

(724,616

)

Proceeds from sales of investments in marketable debt securities

 

194,500

 

415,100

 

Proceeds from maturities of investments in marketable debt securities

 

499,119

 

225,959

 

Capital expenditures

 

(140,952

)

(134,079

)

Purchases of equity securities and interests in affiliated companies

 

(4,291

)

(6,216

)

Proceeds from sale of equity securities and interests in affiliated companies

 

30,036

 

31,421

 

Cash paid for acquisitions, net of cash acquired

 

(3,294

)

(32,289

)

Proceeds from (issuance of) notes receivable

 

(4,967

)

1,479

 

Other, net

 

(10,420

)

(5,167

)

Net cash used in investing activities

 

(154,420

)

(228,408

)

Cash flows from financing activities:

 

 

 

 

 

Repayment of debt and capital leases

 

(599

)

(380,159

)

Payments to acquire treasury stock

 

 

(129,665

)

Proceeds from re-issuance of treasury stock

 

38,619

 

64,178

 

Proceeds from issuance of debt

 

1,002

 

4,996

 

Payment of bond issuance costs

 

 

(8,285

)

Proceeds from issuance of convertible debentures

 

 

385,000

 

Net cash provided by (used in) financing activities

 

39,022

 

(63,935

)

Effect of exchange rate changes on cash and cash equivalents

 

(7,304

)

(3,577

)

Net decrease in cash and cash equivalents

 

(5,141

)

(163,287

)

Cash and cash equivalents at beginning of the period

 

209,509

 

364,270

 

Cash and cash equivalents at end of the period

 

$

204,368

 

$

200,983

 

 

The accompanying Notes to Condensed Consolidated Financial Statements are integral to this statement.

7




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2005
(Unaudited)

Note 1—Basis of Presentation

The information presented in the Condensed Consolidated Financial Statements at September 30, 2005, and for the three and nine months ended September 30, 2005 and 2004, is unaudited but includes all adjustments, consisting only of normal recurring adjustments, which Chiron Corporation believes to be necessary for fair presentation of the periods presented.

The Condensed Consolidated Balance Sheet amounts at December 31, 2004, have been derived from audited financial statements. Historically, Chiron’s operating results have varied considerably from period to period due to the nature of Chiron’s collaborative, royalty and license arrangements and the seasonality of certain vaccine products. In addition, the mix of products sold and the introduction of new products will affect comparability from quarter to quarter. As a consequence, Chiron’s interim results in any one quarter are not necessarily indicative of results to be expected for a full year. This information should be read in conjunction with Chiron’s audited Consolidated Financial Statements as of and for the year ended December 31, 2004, which are included in the Annual Report on Form 10-K filed by Chiron with the Securities and Exchange Commission, or SEC.

Principles of Consolidation

The Condensed Consolidated Financial Statements include the accounts of Chiron and its majority-owned subsidiaries. For consolidated majority-owned subsidiaries in which Chiron owns less than 100%, Chiron records minority interest in the Condensed Consolidated Financial Statements to account for the ownership interest of the minority owner. Investments in limited partnerships and interests in which Chiron has an equity interest of 50% or less are accounted for using either the equity or cost method. All significant intercompany accounts and transactions have been eliminated in consolidation.

Restated Second-Quarter and Third-Quarter 2004 Financial Statements

During our 2004 year-end financial statement review, we determined that certain sales of the travel vaccine recorded as revenues in the second quarter of 2004 should not have been recorded as revenue at that time, and that portions of those sales should have been recorded as revenues in the third and fourth quarters of 2004 and possibly in later quarters. As a result, we restated the financial statements included in our Quarterly Reports on Form 10-Q for such quarters and filed amended Form 10-Qs for such quarters on April 6, 2005.

Use of Estimates and Reclassifications

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an on-going basis, management evaluates its estimates, including those related to investments; inventories; derivatives; capital leases; intangible assets; goodwill; purchased in-process research and development; product discounts, rebates and returns; bad debts; collaborative, royalty and license arrangements; restructuring; pension and other post-retirement benefits; income taxes; and litigation and other contingencies. Chiron bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of

8




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 1—Basis of Presentation (Continued)

which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.

Chiron, prior to filing its financial statements on Form 10-Q, publicly releases an unaudited condensed consolidated balance sheet and statement of operations. Between the date of Chiron’s earnings release and the filing of Form 10-Q, reclassifications may be required. These reclassifications, when made, have no effect on income from continuing operations, net income or earnings per share. There has been no such reclassification in the third quarter of 2005.

Chiron currently owns certain manufacturing and inspection equipment which is no longer useful and became available for sale in 2005. Chiron has committed to a plan to sell these assets and is actively marketing these assets. These assets are classified as “Assets held for sale” in the Condensed Consolidated Balance Sheet at September 30, 2005.

Certain previously reported amounts have been reclassified to conform to the current year presentation.

Stock-Based Compensation

Chiron measures compensation expense for its stock-based employee compensation using the intrinsic value method. Compensation expense is based on the difference, if any, between the fair value of Chiron’s common stock and the exercise price of the option or share right on the measurement date, which is typically the date of grant. This amount is recorded as “Deferred stock compensation” in the Condensed Consolidated Balance Sheets and amortized as a charge to operations over the vesting period of the applicable options or share rights.

9




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 1—Basis of Presentation (Continued)

The following table illustrates the effect on net income and related net income per share, had compensation cost for stock-based employee compensation been determined based upon the fair value method:

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

 

 

(in thousands, except per share data)

 

Net income (loss):

 

 

 

 

 

 

 

 

 

As reported

 

$

51,311

 

$

26,997

 

$

42,418

 

$

102,040

 

Add:

Stock-based employee compensation expense included in reported net income, net of related tax effects

 

1,189

 

1,118

 

3,264

 

3,807

 

Less:

Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

 

17,450

 

23,778

 

53,186

 

68,055

 

Pro forma

 

$

35,050

 

$

4,337

 

$

(7,504

)

$

37,792

 

Basic net income (loss) per share:

 

 

 

 

 

 

 

 

 

As reported

 

$

0.27

 

$

0.14

 

$

0.23

 

$

0.54

 

Pro forma

 

$

0.19

 

$

0.02

 

$

(0.04

)

$

0.20

 

Diluted net income (loss) per share:

 

 

 

 

 

 

 

 

 

As reported

 

$

0.27

 

$

0.14

 

$

0.22

 

$

0.53

 

Pro forma

 

$

0.19

 

$

0.02

 

$

(0.04

)

$

0.20

 

 

Note 2—New Accounting Standards

In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment (SFAS 123(R)), which requires the cost resulting from all share-based payment transactions to be recognized in the consolidated financial statements. That cost will be measured based on the fair value of the equity instruments issued or on the fair value of liabilities incurred. Under SFAS 123(R), the fair-value-based method for recognition or disclosure of compensation expense will be applied using the modified prospective application transition method or the modified retrospective application transition method. Chiron currently measures compensation expense for its stock-based employee compensation under the intrinsic method. Chiron is currently evaluating transition methods, option valuation methodologies and assumptions in light of SFAS 123(R) and, therefore, cannot estimate the impact of its adoption at this time, although Chiron expects that its adoption will have a material impact on Chiron’s consolidated financial statements. Current option values determined using the Black-Scholes-Merton formula, used for purposes of proforma disclosure, may not be indicative of results from the valuation methodologies Chiron finally adopts. The effective date of SFAS 123(R) is the first reporting period beginning after June 15, 2005. However, on April 14, 2005, the Securities and Exchange Commission (SEC) announced the adoption of a new rule that delays the effective date of SFAS 123(R) for registrants, such as Chiron, that are not small business issuers. The

10




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 2—New Accounting Standards (Continued)

SEC’s new rule allows calendar year non-small business issuers to implement SFAS 123(R) at the beginning of 2006, which makes SFAS 123(R) effective for Chiron in the first quarter of 2006.

On October 22, 2004, the American Jobs Creation Act of 2004 (the Act) was signed into law. The Act includes a temporary incentive for U.S. multinationals to repatriate accumulated income earned outside the U.S. at an effective tax rate of 5.25%. On December 21, 2004, the FASB issued Staff Position 109-2, Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provisions within the American Jobs Creation Act of 2004 (FSP 109-2). FSP 109-2 allows companies additional time to evaluate the effect of the law on whether unrepatriated foreign earnings continue to qualify for SFAS No. 109’s exception to recognizing deferred tax liabilities and would require explanatory disclosures from those who need the additional time. Through September 30, 2005, Chiron has not provided deferred taxes on foreign earnings because such earnings were intended to be indefinitely reinvested outside the U.S. Presently Chiron does not have any plan to repatriate earnings under the Act. Accordingly, Chiron has made no change in its current intention to indefinitely reinvest accumulated earnings of its foreign subsidiaries. If Chiron repatriates these earnings, a tax charge to its consolidated results of operations could occur. Chiron will continue to evaluate the impact of this provision.

Note 3—Inventories

Inventories, net of reserves, are stated at the lower of cost or market using the moving weighted-average cost method. Chiron maintains inventory reserves primarily for product failures, expiration and obsolescence. Inventory that is obsolete (inventory that will no longer be used in the manufacturing process), expired, or in excess of forecasted usage is written down to its market value, if lower than cost.

Inventories, net of reserves, consisted of the following:

 

 

September 30,
2005

 

December 31,
2004

 

 

 

(in thousands)

 

Finished goods

 

 

$

84,675

 

 

 

$

59,206

 

 

Work-in-process

 

 

138,211

 

 

 

116,660

 

 

Raw materials

 

 

45,680

 

 

 

45,288

 

 

 

 

 

$

268,566

 

 

 

$

221,154

 

 

 

Note 4—Income Taxes

The effective tax rate was 21.9% and 27.3% of pretax income from continuing operations for the nine months ended September 30, 2005 and 2004, respectively. The tax rate decreased primarily due to lower expected taxable incomes, year to year, in certain high tax jurisdictions, as well as increased benefits of U.S. research credits. Such items are not expected to recur in future years. The effective tax rate may be affected in future periods by changes in management’s estimates with respect to our deferred tax assets and other items affecting the overall tax rate.

11




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 5—Comprehensive Income (Loss)

For the three and nine months ended September 30, 2005 and 2004, the foreign currency translation component of comprehensive income (loss) relates to permanent investments in non-U.S. subsidiaries and, accordingly, was not adjusted for income taxes.

Note 6—Treasury Stock

Treasury stock is stated at cost. Gains on reissuance of treasury stock are credited to “Additional paid-in capital.” Losses on reissuance of treasury stock are charged to “Additional paid-in capital” to the extent of available net gains on reissuance of treasury stock. Otherwise, losses are charged to “Accumulated deficit.” Chiron charged losses of $21.4 million and $45.6 million for the three and nine months ended September 30, 2005, respectively, and $9.0 million and $39.1 million for the three and nine months ended September 30, 2004, respectively, to “Accumulated deficit” in the Condensed Consolidated Balance Sheets.

Note 7—Earnings Per Share

Basic earnings per share is based upon the weighted-average number of common shares outstanding. Diluted earnings per share is based upon the weighted-average number of common shares and dilutive potential common shares outstanding. Dilutive potential common shares could result from (i) the assumed exercise of outstanding stock options and equivalents, which are included under the treasury-stock method; (ii) performance based share rights awards to the extent that dilutive shares are assumed issuable; (iii) the assumed exercise of outstanding put options, which are included under the reverse treasury-stock method; and (iv) convertible notes and debentures, which are included under the if-converted method, if applicable. Due to rounding, quarterly amounts may not sum to full year amounts.

Contingently convertible debt instruments (“CoCos”) are included in diluted earnings per share, if dilutive. For the three months ended September 30, 2005, Chiron’s $500.0 million contingently convertible debentures due 2033 (“2033 Debentures”) were included in the computation of diluted earnings per share. These debentures were not dilutive for the three months ended September 30, 2004. For the three months ended September 30, 2005 and 2004, Chiron’s $385.0 million contingently convertible debentures due 2034 (“2034 Debentures”) were excluded from the computations of diluted earnings per share as the inclusion of these debentures would be antidilutive. For the nine months ended September 30, 2005 and 2004, the 2033 Debentures and the 2034 Debentures were excluded from the computation of diluted earnings per share as the inclusion of each of these CoCos would be antidilutive.

For the three months ended September 30, 2005, the Liquid Yield Option Notes (LYONs) were included in the computation of diluted earnings per share. For the nine months ended September 30, 2005, 0.6 million shares of common stock issuable upon conversion of the LYONs were excluded from the computations of diluted earnings per share as their inclusion would be antidilutive. For the three and nine months ended September 30, 2004, 0.6 million and 4.3 million shares of common stock that would be issued upon conversion of the LYONs were excluded from the computations of diluted earnings per share, as their inclusion would be antidilutive.

12




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 7—Earnings Per Share (Continued)

The following table sets forth the computations for basic and diluted earnings per share on income from continuing operations (in thousands, except per share data):

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

Income (Numerator):

 

 

 

 

 

 

 

 

 

Income from continuing operations

 

$

51,311

 

$

27,447

 

$

42,418

 

$

77,186

 

Plus: Interest on the 2033 Debentures, net of
taxes

 

1,589

 

 

 

 

Plus: Interest on Liquid Yield Option Notes, net
of taxes

 

147

 

 

 

 

Income from continuing operations, plus impact from assumed conversions

 

$

53,047

 

$

27,447

 

$

42,418

 

$

77,186

 

Shares (Denominator):

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding

 

188,039

 

187,368

 

187,564

 

187,751

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Stock options and equivalents

 

1,883

 

2,646

 

1,500

 

3,150

 

2033 Debentures

 

7,306

 

 

 

 

Liquid Yield Option Notes

 

574

 

 

 

 

Weighted-average common shares outstanding, plus impact from assumed conversions

 

197,802

 

190,014

 

189,064

 

190,901

 

Basic earnings per share from continuing operations

 

$

0.27

 

$

0.15

 

$

0.23

 

$

0.41

 

Diluted earnings per share from continuing operations

 

$

0.27

 

$

0.14

 

$

0.22

 

$

0.40

 

 

13




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 7—Earnings Per Share (Continued)

The following table sets forth the computations for basic and diluted earnings per share on net income (in thousands, except per share data):

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

Income (Numerator):

 

 

 

 

 

 

 

 

 

Net income

 

$

51,311

 

$

26,997

 

$

42,418

 

$

102,040

 

Plus: Interest on the 2033 Debentures, net of
taxes

 

1,589

 

 

 

 

Plus: Interest on Liquid Yield Option Notes, net
of taxes

 

147

 

 

 

 

Net income, plus impact from assumed
conversions

 

$

53,047

 

$

26,997

 

$

42,418

 

$

102,040

 

Shares (Denominator):

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding

 

188,039

 

187,368

 

187,564

 

187,751

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Stock options and equivalents

 

1,883

 

2,646

 

1,500

 

3,150

 

2033 Debentures

 

7,306

 

 

 

 

Liquid Yield Option Notes

 

574

 

 

 

 

Weighted-average common shares outstanding, plus impact from assumed conversions

 

197,802

 

190,014

 

189,064

 

190,901

 

Basic earnings per share from net income

 

$

0.27

 

$

0.14

 

$

0.23

 

$

0.54

 

Diluted earnings per share from net income

 

$

0.27

 

$

0.14

 

$

0.22

 

$

0.53

 

 

Stock options to purchase 17.7 million shares and 11.7 million shares with exercise prices greater than the average market prices of common stock were outstanding during the three months ended September 30, 2005 and 2004, respectively, and 19.6 million shares and 10.1 million shares, respectively, for the nine months ended September 30, 2005 and 2004. These options were excluded from the respective computations of diluted earnings per share, as their inclusion would be antidilutive.

The dilutive effect of CoCos must be included in diluted earnings per share regardless of whether the triggering contingency has been satisfied, if dilutive. For the nine months ended September 30, 2005 and the three and nine months ended September 30, 2004, 7.3 million shares of common stock issuable upon conversion of the 2033 Debentures were excluded from the computations of diluted earnings per share as their inclusion would be antidilutive.

If the 2034 Debentures are tendered for conversion, the value (“Conversion Value”) of cash and shares of Chiron’s common stock, if any, to be received by a holder converting $1,000 principal amount of the debentures will be determined by multiplying the applicable conversion rate by a weighted average price. Chiron will deliver the Conversion Value to debenture holders as follows: (1) an amount in cash (“Principal Return”) equal to the lesser of (a) the aggregate Conversion Value of the debentures to be

14




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 7—Earnings Per Share (Continued)

converted and (b) the aggregate principal amount of the debentures to be converted and (2) if the aggregate Conversion Value of the debentures to be converted is greater that the Principal Return, an amount in shares (“Net Shares”) equal to the aggregate Conversion Value less the Principal Return (“Net Share Amount”). The number of Net Shares to be paid will be determined by dividing the Net Share Amount by a weighted average price. If dilutive, common shares to be added to the diluted shares outstanding would be determined by the net share settlement of the 2034 Debentures. For the three and nine months ended September 30, 2005 and 2004, the assumed conversion of the 2034 Debentures was not dilutive.

Note 8—Discontinued Operations

In a strategic effort to focus on Chiron’s core businesses of blood-testing, vaccines and biopharmaceuticals, Chiron completed the sale of Chiron Diagnostics to Bayer Corporation, or Bayer, in 1998.

In the second quarter of 2004, Chiron and the IRS entered into a settlement agreement closing the open tax years 1996 to 1998. Pursuant to this settlement, Chiron recognized a tax benefit of approximately $12.5 million for the nine months ended September 30, 2004.

Chiron and Bayer were involved in a dispute with respect to their respective rights to certain royalty refunds receivable for which a settlement was reached in 2004. Under this settlement agreement, Chiron made a settlement payment to Bayer in 2004. This settlement includes an agreement that all outstanding items with Bayer related to the sale of Chiron Diagnostics are resolved and no future indemnity obligations are required. Chiron released previously established reserves deemed to be in excess following this settlement. This settlement resulted in a net gain of $12.8 million for the nine months ended September 30, 2004. This net gain primarily relates to a tax benefit as a result of the settlement payment to Bayer.

15




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 9—Intangible Assets

Intangible assets subject to amortization consisted of the following (in thousands):

 

 

September 30, 2005

 

December 31, 2004

 

 

 

Gross
Carrying
Value

 

Accumulated
Amortization

 

Net Carrying
Value

 

Gross
Carrying
Value

 

Accumulated
Amortization

 

Net Carrying
Value

 

Purchased technologies

 

$

332,283

 

 

$

131,453

 

 

 

$

200,830

 

 

$

333,085

 

 

$

117,048

 

 

 

$

216,037

 

 

Patents

 

$

141,114

 

 

$

78,061

 

 

 

$

63,053

 

 

$

132,385

 

 

$

71,616

 

 

 

$

60,769

 

 

Trademarks

 

60,330

 

 

25,840

 

 

 

34,490

 

 

65,609

 

 

25,450

 

 

 

40,159

 

 

Licenses and technology rights

 

48,760

 

 

37,692

 

 

 

11,068

 

 

47,745

 

 

34,079

 

 

 

13,666

 

 

Developed product technologies 

 

327,381

 

 

98,595

 

 

 

228,786

 

 

374,025

 

 

77,253

 

 

 

296,772

 

 

Customer relationships

 

27,674

 

 

12,092

 

 

 

15,582

 

 

31,234

 

 

12,421

 

 

 

18,813

 

 

Know how(1)

 

12,568

 

 

7,366

 

 

 

5,202

 

 

14,185

 

 

7,548

 

 

 

6,637

 

 

Databases

 

7,100

 

 

2,367

 

 

 

4,733

 

 

7,100

 

 

2,012

 

 

 

5,088

 

 

Other

 

24,689

 

 

11,609

 

 

 

13,080

 

 

34,893

 

 

19,090

 

 

 

15,803

 

 

Total other intangible assets

 

$

649,616

 

 

$

273,622

 

 

 

$

375,994

 

 

$

707,176

 

 

$

249,469

 

 

 

$

457,707

 

 

Total intangible assets subject to amortization

 

$

981,899

 

 

$

405,075

 

 

 

$

576,824

 

 

$

1,040,261

 

 

$

366,517

 

 

 

$

673,744

 

 


(1)          Upon acquisition of a 100% interest in Chiron Behring by the second quarter 1998, Chiron acquired a portfolio of products that were created by Behring and are currently being sold internationally. These products embody Chiron Behring’s proprietary “know-how” consisting of unpatented technology and trade secrets. Since the unpatented technology and trade secrets meet the separability criterion, Chiron has recognized them collectively as a separate intangible asset apart from goodwill in accordance with SFAS No. 141, Business Combinations.

Aggregate future amortization expense is expected to be as follows (in thousands):

For the nine months ended September 30, 2005

 

$

64,009

 

For the remaining three months in the year ended December 31, 2005

 

$

15,557

 

For the year ended December 31, 2005

 

$

79,566

 

For the year ended December 31, 2006

 

$

68,618

 

For the year ended December 31, 2007

 

$

74,830

 

For the year ended December 31, 2008

 

$

75,239

 

For the year ended December 31, 2009

 

$

73,668

 

For the year ended December 31, 2010

 

$

72,766

 

 

16




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 9—Intangible Assets (Continued)

The changes in the carrying value of goodwill by reporting unit consisted of the following (in thousands):

 

 

Biopharmaceuticals

 

Vaccines

 

Total

 

Balance as of December 31, 2004

 

 

$

192,186

 

 

$

669,208

 

$

861,394

 

Effect of exchange rate changes

 

 

 

 

(55,446

)

(55,446

)

Balance as of September 30, 2005

 

 

$

192,186

 

 

$

613,762

 

$

805,948

 

 

Chiron performed its annual impairment test for goodwill in the third quarter 2005, as of July 1, 2005. Based on this analysis, Chiron has no indication of an impairment loss.

Certain developed product technologies from Chiron’s acquisition of PowderJect are amortized under the estimated sales method, which considers forecasted FLUVIRIN® sales during each influenza season through the remaining period of the benefit. Related amortization was $4.1 million and $30.1 million as compared to $12.3 million and $34.9 million during the three and nine months ended September 30, 2005 and 2004, respectively, reflecting updated forecasted FLUVIRIN® sales.

In the third quarter of 2005, Chiron recognized an impairment loss of $14.5 million on acquired intangible assets from Chiron’s acquisition of PowderJect related to ARILVAX™, a yellow fever vaccine. This impairment loss was due to a focus of resources towards the influenza market, resulting in a reduction of the expected activity for ARILVAX™. ARILVAX™ remains in Chiron’s portfolio of trademarks and Chiron may re-enter the yellow fever vaccine market in the future with this product. ARILVAX™ is included in the caption “Developed product technologies” in the table above.

Note 10—Segment Information

Chiron is organized based on the products and services that it offers. Under this organizational structure, there are three reportable segments: (i) blood-testing, (ii) vaccines and (iii) biopharmaceuticals. The blood-testing segment consists of an alliance with Gen-Probe and Chiron’s one-half share in the pretax operating earnings generated by the joint business contractual arrangement with Ortho-Clinical Diagnostics. Chiron’s alliance with Gen-Probe is focused on developing and commercializing nucleic acid testing products using Transcription-Mediated Amplification technology to screen donated blood, plasma products, organs and tissues for viral infection. Chiron’s joint business arrangement with Ortho-Clinical Diagnostics is operated under a contractual arrangement and is not a separate and distinct legal entity. Through Chiron’s joint business contractual arrangement with Ortho-Clinical Diagnostics, Chiron sells a line of immunodiagnostic tests to detect hepatitis viruses and retroviruses and provides supplemental tests and microplate and chemiluminescent instrument systems to automate test performance and data collection. The blood-testing segment also earns royalties from third parties based on their sales of immunodiagnostic and nucleic acid testing probe diagnostic products utilizing Chiron’s hepatitis C virus and HIV-related patents, for use in blood screening and plasma fractionation markets. The vaccines segment consists principally of adult and pediatric vaccines for viral and bacterial infections. Chiron sells these vaccines primarily in the U.S., Germany, Italy, and the United Kingdom, as well as in other

17




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 10—Segment Information (Continued)

international markets. The vaccines segment is also involved in the development of novel vaccines and vaccination technology. The biopharmaceuticals segment consists of therapeutic products and services, with an emphasis on the treatment of cancer and infectious and pulmonary diseases, using the development and acquisition of technologies related to therapeutic proteins, antibodies and small molecules. The biopharmaceuticals segment earns royalties on third party sales of several products, including BETAFERON® interferon beta-1b, and earns license fees for technologies, such as hepatitis C virus-related patents, used by third parties to develop therapeutic products.

Revenues and expenses associated with Chiron’s research and development activities specifically benefit each of the reportable segments and, as such, have been included in the results of operations of the respective reportable segment.

Chiron views certain other revenues and expenses, particularly certain royalty and license fee revenues primarily related to HIV and hepatitis C virus related patents, and unallocated corporate expenses, as not belonging to any one reportable segment. As a result, Chiron has aggregated these items into an “Other” segment.

The accounting policies of Chiron’s reportable segments are the same as those described in Chiron’s Annual Report on Form 10-K for the year ended December 31, 2004. Chiron evaluates the performance of its segments based on each segment’s income (loss) from continuing operations, excluding certain special items such as purchased in-process research and development, which is shown as a reconciling item in the table below.

18




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 10—Segment Information (Continued)

The following segment information excludes all significant intersegment transactions as these transactions are eliminated for management reporting purposes (in thousands):

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

Restated

 

 

 

Restated

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

Blood-testing:

 

 

 

 

 

 

 

 

 

 

 

Product sales, net:

 

 

 

 

 

 

 

 

 

 

 

PROCLEIX®  products

 

$

70,677

 

 

$

63,629

 

 

$

201,212

 

$

186,104

 

Ortho-Clinical Diagnostics

 

7,023

 

 

7,098

 

 

21,473

 

19,940

 

Total product sales, net

 

77,700

 

 

70,727

 

 

222,685

 

206,044

 

Revenues from joint business arrangement

 

36,093

 

 

34,017

 

 

103,154

 

92,910

 

Collaborative agreement revenues

 

1,579

 

 

1,616

 

 

5,589

 

6,005

 

Royalty and license fee revenues

 

22,501

 

 

34,115

 

 

73,695

 

66,817

 

Other revenues

 

137

 

 

243

 

 

412

 

673

 

Total blood-testing revenues

 

138,010

 

 

140,718

 

 

405,535

 

372,449

 

Vaccines:

 

 

 

 

 

 

 

 

 

 

 

Product sales, net:

 

 

 

 

 

 

 

 

 

 

 

Influenza vaccines

 

60,321

 

 

93,486

 

 

63,400

 

109,398

 

Meningococcal vaccines

 

11,635

 

 

8,865

 

 

34,393

 

18,430

 

Travel vaccines

 

35,012

 

 

26,434

 

 

123,785

 

75,705

 

Pediatric and other vaccines

 

45,800

 

 

44,491

 

 

115,420

 

143,292

 

Total product sales, net

 

152,768

 

 

173,276

 

 

336,998

 

346,825

 

Collaborative agreement revenues

 

999

 

 

2,230

 

 

4,240

 

7,410

 

Royalty and license fee revenues

 

1,263

 

 

1,213

 

 

3,448

 

3,888

 

Other revenues

 

1,802

 

 

3,006

 

 

7,558

 

12,563

 

Total vaccines revenues

 

156,832

 

 

179,725

 

 

352,244

 

370,686

 

Biopharmaceuticals:

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

 

 

 

 

 

 

 

 

 

 

BETASERON®  interferon beta-1b

 

36,927

 

 

35,171

 

 

101,693

 

96,933

 

TOBI® tobramycin

 

57,890

 

 

55,734

 

 

167,425

 

159,600

 

PROLEUKIN® aldesleukin

 

31,028

 

 

31,739

 

 

92,290

 

98,664

 

Other

 

10,862

 

 

8,902

 

 

26,822

 

29,770

 

Total product sales, net

 

136,707

 

 

131,546

 

 

388,230

 

384,967

 

Collaborative agreement revenues

 

571

 

 

278

 

 

1,300

 

1,052

 

Royalty and license fee revenues

 

17,321

 

 

15,412

 

 

55,739

 

47,892

 

Other revenues

 

531

 

 

1,201

 

 

8,251

 

9,127

 

Total biopharmaceuticals revenues

 

155,130

 

 

148,437

 

 

453,520

 

443,038

 

Other:

 

 

 

 

 

 

 

 

 

 

 

Royalty and license fee revenues

 

29,641

 

 

60,656

 

 

94,427

 

102,787

 

Total revenues

 

$

479,613

 

 

$

529,536

 

 

$

1,305,726

 

$

1,288,960

 

Income (loss) from continuing operations:

 

 

 

 

 

 

 

 

 

 

 

Blood-testing

 

$

75,036

 

 

$

80,690

 

 

$

220,171

 

$

203,538

 

Vaccines

 

(28,295

)

 

(65,528

)

 

(195,428

)

(161,880

)

Biopharmaceuticals

 

8,660

 

 

1,683

 

 

5,149

 

29,709

 

Other

 

521

 

 

34,788

 

 

(17,175

)

24,157

 

Segment income from operations

 

55,922

 

 

51,633

 

 

12,717

 

95,524

 

Operating expense reconciling item:

 

 

 

 

 

 

 

 

 

 

 

Purchased in-process research and development

 

 

 

(9,629

)

 

 

(9,629

)

Income from operations

 

55,922

 

 

42,004

 

 

12,717

 

85,895

 

Interest expense

 

(7,759

)

 

(7,063

)

 

(22,932

)

(19,440

)

Interest and other income, net

 

18,514

 

 

5,369

 

 

66,259

 

41,252

 

Minority interest

 

(531

)

 

(504

)

 

(1,723

)

(1,583

)

Income from continuing operations before income taxes

 

$

66,146

 

 

$

39,806

 

 

$

54,321

 

$

106,124

 

 

19




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 11—Commitments and Contingencies

In October 2004, the U.K. regulatory body, the Medicines and Healthcare products Regulatory Agency, or MHRA, suspended Chiron’s license to manufacture FLUVIRIN® at our Liverpool, U.K. facility.

On March 2, 2005, the MHRA notified Chiron that it had lifted the license suspension, giving Chiron clearance to initiate full production of FLUVIRIN® vaccine, conditioned on the understanding that Chiron’s commitment to its remediation plan will continue and will be subject to further inspections by the MHRA.

On October 17, 2005 Chiron initiated delivery and release of FLUVIRIN® vaccine to customers in the United States for the 2005-2006 influenza season. As of such time, Chiron had received all necessary approvals from the U.S. Food and Drug Administration (FDA) and MHRA to start supplying FLUVIRIN® vaccine to the U.S. market. Continued shipments of FLUVIRIN® vaccine will need to undergo corresponding internal release procedures and standard FDA influenza vaccine lot release procedures.

Chiron received a grand jury subpoena issued by the U.S. Attorney’s Office for the Southern District of New York in October 2004 requesting production of certain documents relating to FLUVIRIN® vaccine and the suspension by the MHRA of Chiron’s license. In February 2005, after having previously commenced an informal inquiry, the Securities and Exchange Commission, or SEC, notified Chiron that it would commence a formal investigation into whether Chiron or Chiron employees violated any federal securities laws in connection with these developments regarding FLUVIRIN® vaccine, and Chiron subsequently received subpoenas from the SEC requesting production of certain documents relating to our Liverpool facility and FLUVIRIN® vaccine. Chiron also received a voluntary request for information from the United States House of Representatives, Energy and Commerce Committee, Subcommittee on Oversight and Investigations requesting production of certain documents. Numerous documents have been collected and produced in response to these requests, and several witnesses have been interviewed by the U.S. Attorney’s Office, the SEC staff and Congressional staff. Additional investigations regarding these matters may arise.

In addition, Chiron and certain of its officers and directors have also been named as defendants in several putative shareholder class action and derivative lawsuits alleging various claims arising out of or relating to these developments regarding FLUVIRIN® vaccine. Certain distributors and other parties with whom Chiron had contracted to supply FLUVIRIN® vaccine are considering or have communicated claims against Chiron as a result of our inability to supply FLUVIRIN® vaccine, and additional parties may do so in the future. On January 27, 2005, the U.S. Centers for Disease Control and Prevention, or CDC, terminated its contracts with Chiron for the supply of FLUVIRIN® vaccine for default on the basis of Chiron’s failure to supply such vaccine to the U.S. government for the 2004-2005 influenza season. The CDC has reserved the right to hold Chiron liable for any excess costs it may have incurred in replacing any FLUVIRIN® vaccine that Chiron failed to deliver and further has reserved all other remedies provided under the contract. It is not possible to predict whether any of these claims will be pursued and, if so, whether those claims will be upheld. Investigations, litigation and disputes have caused us to incur substantial expense and have required significant time and attention from Chiron management and will

20




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 11—Commitments and Contingencies (Continued)

continue to do so in the future and could result in civil action and/or criminal proceedings against Chiron. The results of any such investigations, proceedings or disputes could have a material adverse effect on Chiron’s consolidated financial position and results of operations and/or cash flow.

Although the MHRA has lifted its suspension of Chiron’s license to manufacture FLUVIRIN® vaccine, Chiron expects to incur additional expenses in connection with ongoing FLUVIRIN® vaccine matters, which could be material, including in connection with (1) our continuing remediation efforts at our Liverpool facility; and (2) responding to the U.S. Attorney for the Southern District of New York, the SEC, the United States House of Representatives, Energy and Commerce Committee, Subcommittee on Oversight and Investigations and the private lawsuits and other claims and investigations that exist or may arise.

BEGRIVAC™ vaccine is manufactured at Chiron’s facility in Marburg, Germany. In July 2005, Chiron reported that it would be unable to supply any BEGRIVAC™ vaccine doses for the 2005-2006 influenza season due to a product sterility issue and wrote off its existing product inventory resulting in charges of $3.0 million and $18.0 million to cost of sales for the three and nine months ended September 30, 2005, respectively. Investigation of the product sterility issue has been completed and implementation of remedial measures and facility modifications is underway. Chiron’s inability to supply BEGRIVAC™ vaccine as planned to non-U.S. markets for the 2005-2006 season or, if remedial efforts are delayed or not sucessful, future seasons could have a material adverse affect on its business and results of operations. In addition, it is possible that distributors and other parties with whom Chiron had contracted to supply influenza vaccine may make claims against Chiron as a result of Chiron not supplying influenza vaccine. Any such claims may cause Chiron to incur substantial expense and require significant time and attention from Chiron management. The results of any such claims could have a material adverse effect on Chiron’s consolidated financial position and results of operations and/or cash flow.

In addition to the investigations, inquiry and lawsuits related to the recent FLUVIRIN® vaccine developments, Chiron is party to various claims, investigations and legal proceedings arising in the ordinary course of business. These claims, investigations and legal proceedings relate to intellectual property rights, contractual rights and obligations, employment matters, claims of product liability and other issues. While it is possible that an adverse determination of any of such ordinary course matters could have a material adverse impact in any future period, management does not believe, based upon information known to it, that the final resolution of any of these ordinary course matters will have a material adverse effect upon Chiron’s consolidated financial position and results of operations or cash flows.

Chiron’s tax filings are presently under examination in several domestic and international tax jurisdictions. While there is no assurance that Chiron will prevail in all tax examinations in the event the taxing authorities disagree with Chiron’s interpretation of the tax law, Chiron’s management does not believe, based upon information known to it, that the final resolution of any of these audits will have a material adverse effect upon Chiron’s consolidated financial position and results of operations or cash flows. Adequate provisions have been made for these tax examinations.

21




CHIRON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
September 30, 2005
(Unaudited)

Note 12—Subsequent events

On October 30, 2005, Chiron entered into a merger agreement with Novartis Corporation (“Novartis”), Novartis Biotech Partnership, Inc., a subsidiary of Novartis (“Merger Sub”), and Novartis AG.  Pursuant to the terms of the merger agreement, Merger Sub will merge with and into Chiron, with Chiron as the surviving corporation.  In the merger, each share of Chiron common stock, other than those held by Novartis and its affiliates, will be converted into the right to receive $45.00 per share in cash.  Completion of the merger is subject to approval of (1) the holders of a majority of the outstanding shares of Chiron common stock and (2) the holders of a majority of the outstanding shares of Chiron common stock, excluding shares owned by Novartis and its affiliates.  The merger is also subject to the satisfaction of other customary conditions, including governmental and regulatory approvals.  Chiron expects that the transaction will be completed in the first half of 2006.

Immediately prior to signing the merger agreement, Chiron gave notice to Novartis that Chiron was exercising its right under the Subscription Agreement, dated as of November 20, 1994, as amended, with Novartis (as successor to Ciba-Geigy) to require Novartis or its affiliate to purchase shares of Chiron common stock for an aggregate purchase price of $300.0 million at a per share purchase price of $43.50.

 

22




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

Forward-Looking Statements

This Form 10-Q contains forward-looking statements regarding our pending merger with Novartis, our expectations, hopes or intentions regarding the future, including statements relating to sales growth, product development initiatives, new product marketing, acquisitions, competition, and licensing activities that involve risks and uncertainties and are subject to change. The forward-looking statements contained in this Form 10-Q reflect our current expectations on the date of this Form 10-Q. Actual results, performance or outcomes may differ materially from current expectations. Our actual performance may differ from current expectations due to many factors, including additional adverse developments resulting from the suspension from October 5, 2004 through March 2, 2005 of our UK license to manufacture FLUVIRIN® influenza virus vaccine, the announcement of such suspension and the litigation and investigations relating to those matters, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, litigation, stock price and interest rate volatility, marketing effectiveness and the severity of the 2005-2006 influenza season. In particular, there can be no assurance that we will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. No assurances can be given that additional issues with respect to BEGRIVAC™ or FLUVIRIN® vaccines or our manufacturing generally will not arise in the future, that we will be able to cover vaccine shortfalls, or that we will resume sale of BEGRIVAC™ vaccine for the 2006-2007 influenza season. In addition, we may face additional competition in the influenza market in the future and challenges in distribution arrangements as a result of recent BEGRIVAC™ and FLUVIRIN® vaccine developments. There can be no assurance that the merger with Novartis will be completed on a timely basis or completed at all. There can be no assurance that our out-licensing activity will generate significant revenue, or that our in-licensing activities will fully protect us from claims of infringement by third parties. In addition, we may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis, stockholder and regulatory approvals and the integration of operations. We have discussed the important factors, which we believe could cause actual results to differ from what is expressed in the forward-looking statements, under the caption “Factors That May Affect Future Results” in this Form 10-Q. We do not undertake an obligation to update the forward-looking information contained in this Form 10-Q.

Recent Developments

On October 30, 2005, we entered into a merger agreement with Novartis Corporation (“Novartis”), Novartis Biotech Partnership, Inc., a subsidiary of Novartis (“Merger Sub”), and Novartis AG.  Pursuant to the terms of the merger agreement, Merger Sub will merge with and into our company, with our company as the surviving corporation.  In the merger, each share of our common stock, other than those held by Novartis and its affiliates, will be converted into the right to receive $45.00 per share in cash.  Completion of the merger is subject to approval of (1) the holders of a majority of the outstanding shares of our common stock and (2) the holders of a majority of the outstanding shares of our common stock, excluding shares owned by Novartis and its affiliates.  The merger is also subject to the satisfaction of other customary conditions, including governmental and regulatory approvals.  We expect that the transaction will be completed in the first half of 2006.

Immediately prior to signing the merger agreement, we gave notice to Novartis that we were exercising our right under the Subscription Agreement, dated as of November 20, 1994, as amended, with Novartis (as successor to Ciba-Geigy) to require Novartis or its affiliate to purchase shares of our common stock for an aggregate purchase price of $300.0 million at a per share purchase price of $43.50.

23




Introduction

We are a global biopharmaceutical company that participates in three healthcare markets: blood-testing, vaccines, and biopharmaceuticals. Our research and development efforts are focused on developing products for cancer and infectious and pulmonary disease.

Our blood-testing segment is dedicated to preventing the spread of infectious diseases through the development and sale of novel blood-screening assays and equipment that protect the world’s blood supply. We are the world leader in nucleic acid testing, or NAT, blood screening with a leading presence in the U.S, a strong presence in Europe, and sales in Asia. Our blood-testing segment consists of two separate collaborations: an alliance with Gen-Probe Incorporated for NAT products, and a joint business contractual arrangement with Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company for immunodiagnostic products. Our collaboration with Gen-Probe is focused on developing and commercializing NAT products to screen donated blood, plasma, organs and tissue for viral infection. We sell the collaboration’s assays and instruments to blood banks under the PROCLEIX® brand name. Under a joint business contractual arrangement, Ortho-Clinical Diagnostics manufactures and sells immunodiagnostic tests to detect retroviruses and hepatitis viruses in blood. Our blood-testing segment also earns royalties and license fees from third parties based on their sales of immunodiagnostic and nucleic acid testing probe diagnostic products utilizing our hepatitis C virus and HIV-related patents, for use in blood screening and plasma fractionation markets.

Our vaccines segment is the fifth largest vaccines business in the world. We offer more than 20 pediatric and adult vaccines including influenza, meningococcal, travel and pediatric vaccines. These vaccines have protected millions of people globally from potentially fatal diseases such as polio, measles and meningococcal disease. We market our vaccines primarily in the United States, Germany, Italy and the United Kingdom. We acquired a number of vaccines including FLUVIRIN® vaccine as part of our July 8, 2003 acquisition of PowderJect. Our vaccines segment research and development is focused on developing next generation influenza manufacturing capability, developing new vaccines for pandemic preparedness, and broadening our meningococcal franchise.

Our biopharmaceuticals segment researches, develops, manufactures and markets a range of therapeutic products for cancer and infectious and pulmonary disease. Our marketed products include TOBI® tobramycin solution for inhalation for Pseudomonal lung infections in cystic fibrosis patients; PROLEUKIN®(aldesleukin) for injection for metastatic melanoma and renal cell carcinoma; and BETASERON® (interferon beta-1b) for subcutaneous injection for multiple sclerosis. In 2004, we filed for marketing approval in Europe for CUBICIN® (daptomycin for injection) for complicated skin and soft tissue infections. Research and development efforts include advancing clinical programs and product improvements in oncology and pulmonary and infectious disease, including the development of new formulations of TOBI® and the clinical advancement of tifacogin for treatment of severe community-acquired pneumonia, CHIR-258, a growth factor kinase inhibitor, and CHIR-12.12, a monoclonal antibody, and CHIR-265, a Raf kinase inhibitor.

We earn royalty and license fee revenue in all three segments by licensing some of our key intellectual property in areas such as hepatitis C and HIV. In addition, we generate royalties through agreements with development and marketing partners, including royalties from Schering AG’s sales of BETAFERON® (interferon beta-1b) for SC injection in Europe. Some royalties and license fees are not considered to be associated with any particular business segment and are recorded separately in the segment data as Other Royalty and License Fee Revenues.

We view certain other revenues and expenses as not belonging to any one segment. As a result, we have aggregated these items into an “Other” segment.

24




Influenza Virus Vaccines Recent Events

In October 2004, the U.K. regulatory body, the Medicines and Healthcare products Regulatory Agency, or MHRA, suspended our license to manufacture FLUVIRIN® at our Liverpool, U.K. facility. As a result of the suspension of our license, we did not release any FLUVIRIN® vaccine during the 2004-2005 influenza season. On March 2, 2005, the MHRA notified us that it had lifted the license suspension, giving Chiron clearance to initiate full production of FLUVIRIN® vaccine, conditioned on the understanding that Chiron’s commitment to its remediation plan will continue and will be subject to further inspections by the MHRA.

On October 17, 2005 we initiated delivery and release of FLUVIRIN® vaccine to customers in the United States for the 2005-2006 influenza season. As of such time, we had received all necessary approvals from the U.S. Food and Drug Administration (FDA) and MHRA to start supplying FLUVIRIN® vaccine to the U.S. market. Continued shipments of FLUVIRIN® vaccine will need to undergo corresponding internal release procedures and standard FDA influenza vaccine lot release procedures.

We received a grand jury subpoena issued by the U.S. Attorney’s Office for the Southern District of New York in October 2004 requesting production of certain documents relating to FLUVIRIN® vaccine and the suspension by the MHRA of our license. In February 2005, after having previously commenced an informal inquiry, the Securities and Exchange Commission, or SEC, notified us that it would commence a formal investigation into whether we or our employees violated any federal securities laws in connection with these developments regarding FLUVIRIN® vaccine, and Chiron subsequently received subpoenas from the SEC requesting production of certain documents relating to our Liverpool facility and FLUVIRIN® vaccine. We also received a voluntary request for information from the United States House of Representatives, Energy and Commerce Committee, Subcommittee on Oversight and Investigations requesting production of certain documents. Numerous documents have been collected and produced in response to these requests, and several witnesses have been interviewed by the U.S. Attorney’s Office, the SEC staff and Congressional staff. Additional investigations regarding these matters may arise.

In addition, we and certain of our officers and directors have also been named as defendants in several putative shareholder class action and derivative lawsuits alleging various claims arising out of or relating to these developments regarding FLUVIRIN® vaccine which are described below in Part II, Item 1, “Legal Proceedings.” Certain distributors and other parties with whom we had contracted to supply FLUVIRIN® vaccine are considering or have communicated claims against us as a result of our inability to supply FLUVIRIN® vaccine, and additional parties may do so in the future. On January 27, 2005, the U.S. Centers for Disease Control and Prevention, or CDC, terminated its contracts with us for the supply of FLUVIRIN® vaccine for default on the basis of our failure to supply such vaccine to the U.S. government for the 2004-2005 influenza season. The CDC has reserved the right to hold us liable for any excess costs it may have incurred in replacing any FLUVIRIN® vaccine that we failed to deliver and further has reserved all other remedies provided under the contract. It is not possible to predict whether any of these claims will be pursued and, if so, whether those claims will be upheld. Investigations, litigation and disputes have caused us to incur substantial expense and have required significant time and attention from our management and will continue to do so in the future and could result in civil action and/or criminal proceedings against us. The results of any such investigations, proceedings or disputes could have a material adverse effect on our consolidated financial position and results of operations and/or cash flow.

Although the MHRA has lifted its suspension of our license to manufacture FLUVIRIN® vaccine, we expect to incur additional expenses in connection with ongoing FLUVIRIN® vaccine matters, which could be material, including in connection with (1) our continuing remediation efforts at our Liverpool facility; and (2) responding to the U.S. Attorney for the Southern District of New York, the SEC, the United

25




States House of Representatives, Energy and Commerce Committee, Subcommittee on Oversight and Investigations and the private lawsuits and other claims and investigations that exist or may arise.

BEGRIVAC™ vaccine is manufactured at our facility in Marburg, Germany. In July 2005, we reported that we would be unable to supply any BEGRIVAC™ vaccine doses for the 2005-2006 influenza season due to a product sterility issue and wrote off our existing product inventory resulting in charges of $3.0 million and $18.0 million to cost of sales for the three and nine months ended September 30, 2005, respectively. Investigation of the product sterility issue has been completed and implementation of remedial measures and facility modifications is underway. Our inability to supply BEGRIVAC™ vaccine as planned to non-U.S. markets for the 2005-2006 influenza season or, if remedial efforts are delayed or not sucessful, future seasons could have a material adverse affect on our business and results of operations. In addition, it is possible that distributors and other parties with whom we had contracted to supply influenza vaccine may make claims against us as a result of Chiron not supplying influenza vaccine. Any such claims may cause us to incur substantial expense and require significant time and attention from our management. The results of any such claims could have a material adverse effect on our consolidated financial position and results of operations and/or cash flow.

Our inability to supply influenza vaccine may also lead to loss of market share in future seasons. Following the announcement of our FLUVIRIN® license suspension, competitors announced plans to introduce influenza vaccine products in the United States and sought expedited regulatory approval to do so. Even though the license suspension has been lifted, some of our customers may choose to purchase influenza vaccine from other providers as their products become available in the United States. Loss of market share in the United States or foreign markets could have a material adverse effect on our business and results of operations. Delays in start-up procedures for ramping up to full production and normal manufacturing issues inherent in the complexity of influenza vaccine production, have adversely affected the amount of FLUVIRIN® vaccine that Chiron is able to produce for the 2005-2006 influenza season and may result in further loss of market share.

For additional information concerning the risks we face as a result of these influenza vaccine developments, see “Factors That May Affect Future Results—Developments with respect to influenza vaccines over the past year will harm our business and results of operations.” For additional information on the U.S. Attorney’s investigation, SEC investigation and private lawsuits and other claims, see Part II, Item 1. “Legal Proceedings” of this report on Form 10-Q.

Restated Second-Quarter and Third-Quarter 2004 Financial Statements

During our 2004 year-end financial statement review, we determined that certain sales of the travel vaccine recorded as revenues in the second quarter of 2004 should not have been recorded as revenue at that time, and that portions of those sales should have been recorded as revenues in the third and fourth quarters of 2004 and possibly in later quarters. As a result, we restated the financial statements included in our Quarterly Reports on Form 10-Q for such quarters and filed amended Form 10-Qs for such quarters on April 6, 2005.

In light of the fact that we were already in contact with the SEC in relation to their investigation described above under “Influenza Virus Vaccines Recent Events,” we informed the SEC of these matters, and the adjustments we made after January 26, 2005 to the fourth quarter and full-year 2004 financial information we released on January 26, 2005, and have been providing the SEC information pursuant to its requests.

26




Summary Consolidated Financial Data

Following is an analysis and discussion of our operating results on a consolidated basis, which is followed by a description of our most critical accounting policies and use of estimates and more detailed analysis and discussion of our operating results by segment and our liquidity and capital resources.

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

$ Change

 

% Change

 

 

 

2005

 

2004

 

2005

 

2004

 

Three
Months

 

Nine
Months

 

Three
Months

 

Nine
Months

 

 

 

 

 

(Restated)

 

 

 

(Restated)

 

 

 

 

 

 

 

 

 

 

 

($ in 000’s, except per share data)

 

Product sales, net

 

$

367,175

 

 

$

375,549

 

 

$

947,913

 

 

$

937,836

 

 

$

(8,374

)

$

10,077

 

 

(2.2

)%

 

 

1.1

%

 

Revenue from joint business arrangement

 

36,093

 

 

34,017

 

 

103,154

 

 

92,910

 

 

2,076

 

10,244

 

 

6.1

%

 

 

11.0

%

 

Royalty and license fee revenues

 

70,726

 

 

111,396

 

 

227,309

 

 

221,384

 

 

(40,670

)

5,925

 

 

(36.5

)%

 

 

2.7

%

 

Total revenues

 

479,613

 

 

529,536

 

 

1,305,726

 

 

1,288,960

 

 

(49,923

)

16,766

 

 

(9.4

)%

 

 

1.3

%

 

Gross profit Margin

 

54

%

 

36

%

 

46

%

 

47

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

107,309

 

 

103,000

 

 

324,620

 

 

301,736

 

 

4,309

 

22,884

 

 

4.2

%

 

 

7.6

%

 

Selling, general and administrative expenses

 

117,152

 

 

112,013

 

 

375,802

 

 

321,775

 

 

5,139

 

54,027

 

 

4.6

%

 

 

16.8

%

 

Purchased in-process research and development

 

 

 

9,629

 

 

 

 

9,629

 

 

(9,629

)

(9,629

)

 

(100

)%

 

 

(100

)%

 

Impairment loss on acquired intangible assets

 

14,522

 

 

 

 

14,522

 

 

 

 

14,522

 

14,522

 

 

100

%

 

 

100

%

 

Amortization expense of intangible assets acquired in business combinations and asset purchases

 

12,361

 

 

20,566

 

 

54,237

 

 

63,077

 

 

(8,205

)

(8,840

)

 

(39.9

)%

 

 

(14.0

)%

 

Income from continuing operations

 

51,311

 

 

27,447

 

 

42,418

 

 

77,186

 

 

23,864

 

(34,768

)

 

86.9

%

 

 

(45.0

)%

 

Diluted earnings per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income from continuing operations

 

$

0.27

 

 

$

0.14

 

 

$

0.22

 

 

$

0.40

 

 

$

0.13

 

$

(0.18

)

 

92.9

%

 

 

(45.0

)%

 

 

Income from continuing operations was $51.3 million or $0.27 per diluted share and $27.4 million or $0.14 per diluted share for the three months ended September 30, 2005 and 2004, respectively. Income from continuing operations was $42.4 million or $0.22 per diluted share and $77.2 million or $0.40 per diluted share for the nine months ended September 30, 2005 and 2004, respectively. Income from continuing operations increased for the three months ended September 30, 2005 as compared with the three months ended September 30, 2004 primarily due to a $91.3 million charge to cost of sales resulting from the write-off of our entire FLUVIRIN® vaccine inventory in the third quarter of 2004 and $8.2 million lower amortization expense in the third quarter of 2005, resulting from a revision of estimated future sales. The amortization expense related to certain developed product technologies from our acquisition of PowderJect, which are amortized under the estimated sales method over ten years. These increases were partially offset by $46.0 million of royalties and license fees recognized from the F. Hoffman-LaRoche settlement (the Roche settlement) in the third quarter of 2004 compared with $8.0 million recognized in the third quarter of 2005 and the impairment loss of $14.5 million on acquired intangible assets from our acquisition of PowderJect related to a yellow fever vaccine in the third quarter of 2005. In addition, there was a lost contribution from sales of BEGRIVAC™ influenza virus vaccine as there were no sales of BEGRIVAC™ vaccine in the third quarter of 2005, compared to $41.0 million of sales for the three months ended September 30, 2004. Income from continuing operations decreased for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 primarily due to $46.0 million of royalties and license fees recognized from the Roche settlement for the nine months ended September 30, 2004 compared with $32.0 million of royalties and license fee revenues

27




recognized for the nine months ended September 30, 2005 and the impairment loss of $14.5 million on acquired intangible assets from our acquisition of PowderJect related to a yellow fever vaccine in the third quarter of 2005. Lastly, there was a lost contribution from sales of BEGRIVAC™ influenza virus vaccine as there were no sales of BEGRIVAC™ vaccine for the nine months ended September 30, 2005, compared to $41.0 million of sales for the nine months ended September 30, 2004. These decreases were partially offset by a $91.3 million charge to cost of sales resulting from the write-off of our entire FLUVIRIN® vaccine inventory in the third quarter of 2004 and $4.8 million lower amortization expense for the nine months ended September 30, 2005 related to certain developed product technologies from our acquisition of PowderJect, which are amortized under the estimated sales method over ten years, resulting from a revision of estimated future sales. For the three months ended September 30 2005, we incurred $3.0 million of FLUVIRIN® vaccine remediation costs and $0.5 million of legal costs associated with the FLUVIRIN® vaccine-related developments. For the nine months ended September 30, 2005, we incurred $27.0 million of FLUVIRIN® vaccine remediation costs and $15.5 million of legal costs associated with the FLUVIRIN® vaccine-related developments. In addition, our Liverpool facility had limited influenza vaccine production during the first nine months of 2005. For the three months ended September 30, 2005 as compared with the three months ended September 30, 2004, idle facility costs from our Liverpool facility increased by $9.0 million. For the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004, idle facility costs from our Liverpool facility increased by $36.0 million. In addition, BEGRIVAC™ product inventory has been written off as a result of the matters described above under “Influenza Virus Vaccines Recent Events”, resulting in charges of $3.0 million and $18.0 million to cost-of-sales for the three and nine months ended September 30, 2005 respectively.

Revenues decreased for the three months ended September 30, 2005 as compared with the three months ended September 30, 2004 primarily due to decreased royalty and license fee revenues and product sales. Revenues increased for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 primarily due to increased revenues from the joint business arrangement, increased royalty and license fee revenues and increased product sales. The change in total revenues was attributable in part to the movement in exchange rates, in particular the movements in the Euro and British Pound against the U.S. dollar. The movement in exchange rates reduced by approximately 1% our total revenues for the nine months ended September 30, 2005. However, since our Euro and British Pound denominated expenses have also changed due to the movement in exchange rates, our income per share from continuing operations increased $0.02 per diluted share for the nine months ended September 30, 2005, due to higher expenses compared with revenues denominated in Euros and British Pounds.

For the three months ended September 30, 2005, product sales decreased as compared with the three months ended September 30, 2004 primarily due to lower influenza vaccine sales because we were unable to supply any BEGRIVAC™ vaccine doses for the 2005-2006 influenza season due to a product sterility issue. There was $41.0 million of sales of BEGRIVAC™ vaccine in the third quarter of 2004. This decrease was offset by increases in our travel vaccines, PROCLEIX® product sales, Meningococcal vaccines, TOBI® tobramycin and BETASERON® interferon beta-1b.

For the nine months ended September 30, 2005, product sales increased compared with the nine months ended September 30, 2004 primarily due to increases in sales of our travel vaccines, Meningococcal vaccines, PROCLEIX® product sales and TOBI® tobramycin, offset primarily by decreases in sales of our influenza vaccines and pediatric and other vaccines as discussed below. Sales of our influenza vaccine decreased primarily due to lower influenza vaccine sales because we were unable to supply any BEGRIVAC™ vaccine doses for the 2005-2006 influenza season due to a product sterility issue.

For the three months ended September 30, 2005, royalty and license fee revenues decreased compared with the three months ended September 30, 2004 primarily due to recognition of $46.0 million in

28




the third quarter of 2004 relating to the Roche settlement, as compared with recognition of $8.0 million in the third quarter of 2005 relating to the settlement. For the nine months ended September 30, 2005, royalties and license fee revenues increased as compared with the nine months ended September 30, 2004 primarily due to increased BETAFERON® product royalties and our settlement with the Scottish National Blood Transfusion Service. These increases were partially offset by royalties and license fees recognized from the Roche settlement in the third quarter of 2004. The increase in revenue from the joint business arrangement for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 was primarily due to higher profitability realized by the joint business arrangement.

Gross profit margin increased for the three months ended September 30, 2005 as compared with the three months ended September 30, 2004 primarily due to a $91.3 million charge to cost of sales resulting from the write-off of our entire FLUVIRIN® inventory in the third quarter of 2004, partially offset by there being no BEGRIVAC™ vaccine sales for the three months ended September 30, 2005.

Gross profit margin decreased for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 primarily due to increased idle facility costs as a result of the delay in commercial production of FLUVIRIN® vaccine for the 2005-2006 influenza season, FLUVIRIN® vaccine remediation costs and the write-off of the BEGRIVAC™ product inventory and the resulting loss of BEGRIVAC™ vaccine sales for the three months ended September 30, 2005. These decreases were primarily offset by a $91.3 million charge to cost of sales resulting from the write-off of our entire Fluvirin inventory in the third quarter of 2004.

Gross profit margins do not include amortization expense of intangible assets from acquired developed products related to business combinations.

The main components of the increase in research and development expenses for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 relate to development efforts in our oncology franchise, development efforts for CUBICIN® (daptomycin for injection), meningococcal vaccines franchise, flu cell culture, development of new processes and procedures in existing manufacturing facilities for BETAFERON interferon beta-1b and blood-testing programs. These increases were partially offset by research and development programs that have been discontinued or disposed of prior to the first nine months of 2005.

The increase in selling, general and administrative expenses for the three months ended September 30, 2005 as compared with the three months ended September 30, 2004 was due primarily to pre-launch costs for CUBICIN® (daptomycin for injection), higher employee related expenses and higher corporate governance costs.

The increase in selling, general and administrative expenses for the nine months ended September 30, 2005 as compared with the nine months ended September 30, 2004 was due partially to legal expenses associated with the FLUVIRIN® developments discussed above under “Influenza Virus Vaccines Recent Events.” Such legal expenses were $15.5 million for the nine months ended September 30, 2005. The increase also reflects $4.3 million due to the movement in the Euro and British Pound exchange rates. The remaining increase in selling, general and administrative expenses reflects a broad range of activities, significant among them being on-going marketing and pre-launch programs to support the continued growth of our business, investment in geographic penetration, higher employee related costs and corporate governance costs.

The effective tax rate was 21.9% and 27.3% of pretax income from continuing operations for the nine months ended September 30, 2005 and 2004, respectively. The tax rate decreased primarily due to lower expected taxable incomes, year to year, in certain high tax jurisdictions, as well as increased benefits of U.S. research credits. Such items are not expected to recur in future years. The effective tax rate may be

29




affected in future periods by changes in management’s estimates with respect to our deferred tax assets and other items affecting the overall tax rate.

Critical Accounting Policies and the Use of Estimates

Our critical accounting policies, which incorporate our more significant judgments and estimates used in the preparation of our Condensed Consolidated Financial Statements, are the same as those described in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2004.

The preparation of financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to investments; inventories; derivatives; capital leases; intangible assets; goodwill; purchased in-process research and development; product discounts, rebates and returns; bad debts; collaborative, royalty and license arrangements; restructuring; pension and other post-retirement benefits; income taxes; and litigation and other contingencies. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.

Results of Operations

Blood-testing

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

$ Change

 

% Change

 

 

 

2005

 

2004

 

2005

 

2004

 

Three
Months

 

Nine
Months

 

Three
Months

 

Nine
Months

 

 

 

($ in 000’s, except percentages)

 

Product sales, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROCLEIX® products

 

$

70,677

 

$

63,629

 

$

201,212

 

$

186,104

 

$

7,048

 

$

15,108

 

 

11.1

%

 

 

8.1

%

 

Ortho-Clinical Diagnostics

 

7,023

 

7,098

 

21,473

 

19,940

 

(75

)

1,533

 

 

(1.1

)%

 

 

7.7

%

 

 

 

77,700

 

70,727

 

222,685

 

206,044

 

6,973

 

16,641

 

 

9.9

%

 

 

8.1

%

 

Revenue from joint business arrangement

 

36,093

 

34,017

 

103,154

 

92,910

 

2,076

 

10,244

 

 

6.1

%

 

 

11.0

%

 

Collaborative agreement revenues

 

1,579

 

1,616

 

5,589

 

6,005

 

(37

)

(416

)

 

(2.3

)%

 

 

(6.9

)%

 

Royalty and license fee
revenues

 

22,501

 

34,115

 

73,695

 

66,817

 

(11,614

)

6,878

 

 

(34.0

)%

 

 

10.3

%

 

Other revenues

 

137

 

243