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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 June 30, 2002

   
 

OR

   

[  ]

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: 1-9813

GENENTECH, INC.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction
of incorporation or organization)

94-2347624
(I.R.S. Employer
Identification Number)

1 DNA Way, South San Francisco, California  94080-4990
(Address of principal executive offices and zip code)

(650) 225-1000
(Telephone Number)

     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 [ ]

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

 

Class

Number of Shares Outstanding

Common Stock $0.02 par value

517,856,470 Outstanding at June 30, 2002


 


 

GENENTECH, INC.
TABLE OF CONTENTS

   

Page No.

 

PART I - FINANCIAL INFORMATION

 

Item 1.

Financial Statements

 

 

Condensed Consolidated Statements of Operations -
for the three months and six months ended June 30, 2002 and 2001


3    

 

Condensed Consolidated Statements of Cash Flows -
for the six months ended June 30, 2002 and 2001


4    

 

Condensed Consolidated Balance Sheets -
June 30, 2002 and December 31, 2001


5    

 

Notes to Condensed Consolidated Financial Statements

6 - 13    

 

Independent Accountants' Review Report

14    

Item 2.

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

 

 

Financial Review

15 - 34    

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35    

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

36    

Item 4.

Submission of Matters to a Vote of Security Holders

37    

Item 6.

Exhibits and Reports on Form 8-K

38    

     

SIGNATURES

39    

 

In this report, "Genentech," "we," "us" and "our" refer to Genentech, Inc. "Common Stock" refers to Genentech's common stock, par value $0.02 per share and "Special Common Stock" refers to Genentech's callable putable common stock, par value $0.02 per share.

We own or have rights to various copyrights, trademarks and trade names used in our business including the following: Actimmune® interferon gamma-1b; Activase® (alteplase, recombinant) tissue-plasminogen activator; Avastin™ (bevacizumab) anti-VEGF antibody; Cathflo™ Activase (alteplase for catheter clearance); Herceptin® (trastuzumab) anti-HER2 antibody; Nutropin® (somatropin (rDNA origin) for injection) growth hormone; Nutropin AQ® (somatropin (rDNA origin) injection) liquid formulation growth hormone; Nutropin Depot® (somatropin (rDNA origin) for injectable suspension) encapsulated sustained-release growth hormone; Protropin® (somatrem for injection) growth hormone; Pulmozyme® (dornase alfa, recombinant) inhalation solution; TNKase™ (tenecteplase) single-bolus thrombolytic agent; and Raptiva™ (efalizumab, formerly Xanelim) anti-CD11a antibody. Rituxan® (rituximab) anti-CD20 antibody is a registered trademark of IDEC Pharmaceuti cals Corporation; Tarceva™ (erlotinib) is a trademark of OSI Pharmaceuticals, Inc.; and Xolair™ (omalizumab) anti-IgE antibody is a trademark of Novartis AG. This report also includes other trademarks, service marks and trade names of other companies.

 

2



 

PART I - FINANCIAL INFORMATION

Item 1.  Financial Statements

GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)
(unaudited)

 

Three Months
Ended June 30,


 

Six Months
Ended June 30,


 

2002


 

2001


 

2002


 

2001


Revenues:

                     

   Product sales (including amounts from related party:
      three months - 2002-$31,318; 2001-$16,265;
      six months - 2002-$52,665; 2001-$38,302)


$

523,527 

 


$

410,258 

 



$



1,000,077 

 



$



802,161 

   Royalties (including amounts from related party:
      three months - 2002-$33,425; 2001-$17,801;
      six months - 2002-$59,275; 2001-$41,420)

 

85,535 

   

52,446 

   



167,378 

   



127,077 

   Contract and other (including amounts from related parties:
      three months - 2002-$4,842; 2001-$487;
      six months - 2002-$8,653; 2001-$2,686)

 

13,286 

   

20,935 

   



40,051 

   



59,419 

   Interest income

 

29,964 

   

32,235 

   

58,258 

   

67,299 

      Total revenues

 

652,312 

   

515,874 

   

1,265,764 

   

1,055,956 

 
 
 
 

Costs and expenses

                     

   Cost of sales (including amounts for related party:
      three months - 2002-$26,061; 2001-$13,546;
      six months - 2002-$44,884; 2001-$32,052)

 

106,867 

   

76,188 

   



209,311 

   



159,984 

   Research and development (including contract related:
      three months - 2002-$8,057; 2001-$3,391;
      six months - 2002-$12,507; 2001-$6,339)

 

147,922 

   

123,448 

   



294,613 

   



259,788 

   Marketing, general and administrative

 

126,915 

   

107,800 

   

250,542 

   

235,719 

   Collaboration profit sharing

 

84,090 

   

57,908 

   

156,168 

   

104,281 

   Recurring charges related to redemption

 

38,928 

   

81,490 

   

77,856 

   

163,007 

   Special charges: litigation-related

 

518,000 

   

-  

   

518,000 

   

-  

   Interest expense

 

-  

   

1,345 

   

753 

   

2,836 

      Total costs and expenses

 

1,022,722 

   

448,179 

   

1,507,243 

   

925,615 





Income (loss) before taxes and cumulative effect of accounting change

 

(370,410)

   

67,695 

   

(241,479)

   

130,341 

Income tax (benefit) provision

(156,762)

   

29,047 

   

(123,134)

   

59,305 

 
 
 
 

Income (loss) before cumulative effect of accounting change

 

(213,648)

   

38,648 

   

(118,345)

   

71,036 

Cumulative effect of accounting change, net of tax

 

-  

   

-  

   

-  

   

(5,638)

 
 
 
 

Net income (loss)

$

(213,648)

 

$

38,648 

 

$

(118,345)

 

$

65,398 

 
 
 
 

Earnings (loss) per share:

                     

   Basic:

                     

      Earnings (loss) before cumulative effect of accounting change

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.13 

      Cumulative effect of accounting change, net of tax

 

-  

   

-  

   

-  

   

(0.01)

 
 
 
 

      Net earnings (loss) per share

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.12 

 
 
 
 

   Diluted:

                     

      Earnings (loss) before cumulative effect of accounting change

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.13 

      Cumulative effect of accounting change, net of tax

 

-  

   

-  

   

-  

   

(0.01)

 
 
 
 

      Net earnings (loss) per share

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.12 

 
 
 
 

Weighted-average shares used to compute basic earnings (loss) per
      share

 

520,001

   

526,998 

   


523,361

   


526,396 

 
 
 
 

Weighted-average shares used to compute diluted earnings (loss) per
      share

 

520,001

   

535,142 

   


523,361

   


535,181 

 
 
 
 

See Notes to Condensed Consolidated Financial Statements.

 

3


 

GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)

 

Six Months
Ended June 30,


 

2002


 

2001


Cash flows from operating activities:

         

   Net (loss) income

$

(118,345)

 

$

65,398 

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

         

      Depreciation and amortization

 

136,245 

   

212,312 

      Deferred income taxes

 

(213,256)

   

16,283 

      Gain on sales of securities available-for-sale

 

(34,476)

   

(27,494)

      Loss on sales of securities available-for-sale

 

3,775 

   

1,913 

      Write-down of securities available-for-sale

 

9,451 

   

21,209 

      Loss on fixed asset dispositions

 

9,125 

   

1,145 

   Changes in assets and liabilities:

         

      Litigation-related liability

 

518,000 

   

-  

      Investments in trading securities

 

(109,959)

   

(66,988)

      Receivables and other current assets

 

(16,241)

   

(17,435)

      Inventories

 

(23,251)

   

(50,489)

      Accounts payable, other current liabilities and other long-term liabilities

 

28,184 

   

4,207 

 
 

   Net cash provided by operating activities

 

189,252 

   

160,061 

       

Cash flows from investing activities:

         

   Purchases of securities available-for-sale

 

(460,615)

   

(822,870)

   Proceeds from sales of securities available-for-sale

 

768,427 

   

576,144 

   Purchases of nonmarketable equity securities

 

(1,250)

   

(10,830)

   Capital expenditures

 

(163,816)

   

(85,668)

   Change in other assets

 

(10,382)

   

(57,736)

 
 

   Net cash provided by (used in) investing activities

 

132,364 

   

(400,960)

       

Cash flows from financing activities:

         

   Stock issuances

 

43,704 

   

63,083 

   Stock repurchases

 

(491,212)

   

-  

   Repayment of short-term debt

 

(149,692)

   

-  

 
 

   Net cash (used in) provided by financing activities

 

(597,200)

   

63,083 

 
 

Net decrease in cash and cash equivalents

 

(275,584)

   

(177,816)

   Cash and cash equivalents at beginning of period

 

395,203 

   

551,384 

 
 

   Cash and cash equivalents at end of period

$

119,619 

 

$

373,568 

 
 

 

See Notes to Condensed Consolidated Financial Statements.

 

4


 

GENENTECH, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)

 

June 30,
2002


 

December 31,
2001


ASSETS

         

Current assets:

         

   Cash and cash equivalents

$

119,619 

 

$

395,203 

   Short-term investments

 

849,457 

   

952,875 

   Accounts receivable - net (including amounts from related
      parties: 2002-$65,623; 2001-$54,825)

 


327,505 

   


303,298 

   Inventories

 

380,197 

   

356,946 

   Prepaid expenses and other current assets

 

196,789 

   

201,030 

 
 

      Total current assets

 

1,873,567 

   

2,209,352 

Long-term marketable securities

 

1,085,251 

   

1,468,450 

Property, plant and equipment (net of accumulated depreciation:
   2002-$686,401; 2001-$636,227)

 


969,277 

   


865,668 

Goodwill (net of accumulated amortization in 2001 of $996,779)

 

1,334,219 

   

1,302,493 

Other intangible assets (net of accumulated amortization:
   2002-$1,494,198; 2001-$1,459,285)

 


1,004,805 

   


1,113,299 

Other long-term assets

 

326,615 

   

175,585 

 
 

Total assets

$

6,593,734 

 

$

7,134,847 

 
 

LIABILITIES AND STOCKHOLDERS' EQUITY

         

Current liabilities:

         

   Accounts payable

$

54,824 

 

$

33,348 

   Short-term debt

 

-  

   

149,692 

   Other accrued liabilities (including amounts to related
       parties: 2002-$45,125; 2001-$45,259)

 


467,790 

   


468,715 

 
 

      Total current liabilities

 

522,614 

   

651,755 

Deferred tax liabilities

 

189,405 

   

447,809 

Deferred revenue

 

66,083 

   

68,033 

Litigation-related and other long-term liabilities

 

520,719 

   

47,431 

 
 

      Total liabilities

 

1,298,821 

   

1,215,028 

           

Commitments and contingencies

         
           

Stockholders' equity:

         

   Preferred stock

 

-  

   

-  

   Common stock

 

10,357 

   

10,566 

   Additional paid-in capital

 

6,693,840 

   

6,794,831 

   Accumulated deficit, since June 30, 1999

 

(1,652,231)

   

(1,197,300)

   Accumulated other comprehensive income

 

242,947 

   

311,722 

 
 

      Total stockholders' equity

 

5,294,913 

   

5,919,819 

 
 

Total liabilities and stockholders' equity

$

6,593,734 

 

$

7,134,847 

 
 

 

See Notes to Condensed Consolidated Financial Statements.

 

5


 

GENENTECH, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)

Note 1.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting only of adjustments of a normal recurring nature) considered necessary for a fair presentation have been included. Operating results for the three- and six-month periods ended June 30, 2002, are not necessarily indicative of the results that may be expected for the year ending December 31, 2002. The condensed consolidated balance sheet as of December 31, 2001 has been derived from the audited financial statements as of that date. For further informat ion, refer to the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2001.

Use of Estimates

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

Stock Award Plans

We have elected to continue to follow Accounting Principles Board (or APB 25) to account for employee stock options because the alternative fair value method of accounting prescribed by FAS 123, "Accounting for Stock-Based Compensation," requires the use of option valuation models that were not developed for use in valuing employee stock options. Under APB 25, "Accounting for Stock Issued to Employees," no compensation expense is recognized because the exercise price of our employee stock options equals the market price of the underlying stock on the date of grant.

Change in Accounting Principle

On January 1, 2001, we adopted Statement of Financial Accounting Standards (or FAS) No. 133, "Accounting for Derivative Instruments and Hedging Activities" as amended by FAS 138, "Accounting for Certain Derivative Instruments and Certain Hedging Activities." FAS 133 requires us to recognize all derivatives on the balance sheet at fair value. Derivatives that are not designated as hedges must be adjusted to fair value through earnings. If the derivative is designated and qualifies as a hedge, depending on the nature of the hedge, changes in the fair value of the derivative are either offset against the change in fair value of assets, liabilities, or firm commitments through earnings or recognized in other comprehensive income until the hedged item is recognized in earnings. The ineffective portion of a derivative's change in fair value is immediately recognized in earnings. The adoption of FAS 133 on January 1, 2001, resulted in a $5.6 million charge, net of tax, ($0.01 per share) a s a cumulative effect of an accounting change, the recognition of $6.0 million in gains, net of tax, ($0.01 per share) related to the change in the time value of certain hedging instruments in the statement of operations, and an increase of $5.0 million, net of tax, in other comprehensive income.

Recent Accounting Pronouncements

On January 1, 2002, we adopted FAS 141, "Business Combinations" and FAS 142, "Goodwill and Other Intangible Assets." FAS 141 requires that the purchase method of accounting be used for all business combinations initiated after June 30, 2001, and also specifies the criteria for the recognition of intangible assets separately from goodwill. Under the new rules, goodwill is no longer amortized but is subject to an impairment test at least annually. Separately identified and recognized intangible assets resulting from business combinations completed before July 1, 2001, that did not meet the new criteria for separate recognition of intangible assets were subsumed in goodwill upon adoption. FAS 141 specifically identified assembled workforce as an intangible asset that is not to be recognized apart from goodwill and it was subsumed into goodwill on January 1, 2002. Other intangible assets that meet the new criteria continue to be amortized over their useful lives.

 

6



 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
 

     In accordance with FAS 141 and 142, we discontinued the amortization of goodwill and our trained and assembled workforce intangible asset, which resulted in a decrease in reported net loss by approximately $39.4 million, net of tax, (or $0.08 per share) in the second quarter ended June 30, 2002, and by approximately $78.8 million, net of tax, (or $0.15 per share) in the first six months of 2002 as compared to the accounting prior to the adoption of FAS 141 and 142. We performed an impairment test of goodwill as of January 1, 2002, which did not result in an impairment charge at transition. We will continue to monitor the carrying value of our goodwill through the annual impairment tests. See also Note 5, "Goodwill and Other Acquisition-Related Intangible Assets."

     A reconciliation of previously reported net income and earnings per share to the amounts adjusted for the exclusion of goodwill amortization and the amortization of our trained and assembled workforce intangible asset, net of the related income tax, follows (in millions, except per share amounts):

 

Three Months
Ended June 30,


 

Six Months
Ended June 30,


 

2002


 

2001


 

2002


 

2001


Reported net income (loss)

$

(213.6)

 

$

38.6 

 

$

(118.3)

 

$

65.4 

Add back: Goodwill amortization

 

-  

   

38.3 

   

-  

   

76.6 

                 Trained and assembled workforce amortization

 

-  

   

1.1 

   

-  

   

2.2 

 
 
 
 

Adjusted net income (loss)

$

(213.6)

 

$

78.0 

 

$

(118.3)

 

$

144.2 

 
 
 
 

Basic earnings (loss) per share:

                     

   Reported net income (loss)

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.12 

   Goodwill amortization

 

-  

   

0.08 

   

-  

   

0.15 

   Trained and assembled workforce amortization

 

-  

   

-  

   

-  

   

-  

 
 
 
 

   Adjusted net income (loss)

$

(0.41)

 

$

0.15 

 

$

(0.23)

 

$

0.27 

 
 
 
 

Diluted earnings (loss) per share:

                     

   Reported net income (loss)

$

(0.41)

 

$

0.07 

 

$

(0.23)

 

$

0.12 

   Goodwill amortization

 

-  

   

0.08 

   

-  

   

0.15 

   Trained and assembled workforce amortization

 

-  

   

-  

   

-  

   

-  

 
 
 
 

   Adjusted net income (loss)

$

(0.41)

 

$

0.15 

 

$

(0.23)

 

$

0.27 

 
 
 
 

We adopted FAS 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" on January 1, 2002. FAS 144 supersedes FAS 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of." The primary objectives of FAS 144 are to develop one accounting model based on the framework established in FAS 121 for long-lived assets to be disposed of by sale, and to address significant implementation issues. Our adoption of FAS 144 did not have a material impact on our financial position or results of operations.

 

Note 2.

LEGAL PROCEEDINGS

We are a party to various legal proceedings, including patent infringement litigation relating to our antibody products, and one of our thrombolytic products, and licensing and contract disputes, and other matters.

On May 28, 1999, GlaxoSmithKline plc (or Glaxo) filed a patent infringement lawsuit against us in the U.S. District Court in Delaware. The suit asserted that we infringe four U.S. patents owned by Glaxo. Two of the patents relate to the use of specific kinds of antibodies for the treatment of human disease, including cancer. The other two patents asserted against us relate to preparations of specific kinds of antibodies which are made more stable and the methods by which such preparations are made. After a trial, the jury hearing the lawsuit unanimously found that our Herceptin and Rituxan antibody products do not infringe the patents and therefore that Genentech is not required to pay royalties to Glaxo. The jury also unanimously found that all of the patent claims that Glaxo asserted against Genentech were invalid. Glaxo filed an appeal of the jury's verdict with the U.S. Court of Appeals for the Federal Circuit. The oral argument of the appeal took place on February 6, 2002. Pro ceedings in connection with Genentech's claim against Glaxo for inequitable conduct and other related issues are still pending before the District Court.

 

7



 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
 

On September 14, 2000, Glaxo filed another patent infringement lawsuit against us in the U.S. District Court in Delaware, alleging that we are infringing U.S. Patent No. 5,633,162 owned by Glaxo. The patent relates to specific methods for culturing Chinese Hamster Ovary cells. The complaint fails to specify which of our products or methods of manufacture are allegedly infringing that patent. However, the complaint makes a general reference to Genentech's making, using, and selling "monoclonal antibodies," and so we believe that the suit relates to our Herceptin and Rituxan antibody products. We filed our answer to Glaxo's complaint, and in our answer we also stated counterclaims against Glaxo. The jury trial of this suit is scheduled to begin on April 14, 2003. This lawsuit is separate from and in addition to the Glaxo suit mentioned above.

We and the City of Hope Medical Center are parties to a 1976 agreement relating to work conducted by two City of Hope employees, Arthur Riggs and Keiichi Itakura, and patents that resulted from that work, which are referred to as the "Riggs/Itakura Patents." Since that time, Genentech has entered into license agreements with various companies to make, use and sell the products covered by the Riggs/Itakura Patents. On August 13, 1999, the City of Hope filed a complaint against us in the Superior Court in Los Angeles County, California, alleging that we owe royalties to the City of Hope in connection with these license agreements, as well as product license agreements that involve the grant of licenses under the Riggs/Itakura Patents. The complaint stated claims for declaratory relief, breach of contract, breach of implied covenant of good faith and fair dealing, and breach of fiduciary duty. On December 15, 1999, we filed our answer to the City of Hope's complaint. The first trial of t his suit began on August 28, 2001, in which City of Hope was seeking compensatory damages in the amount of approximately $445 million (including interest) and special damages. On October 24, 2001, the jury hearing the lawsuit announced that it was unable to reach a verdict and on that basis the Court declared a mistrial. City of Hope requested a retrial, and the retrial began on March 20, 2002. On June 10, 2002, the jury voted to award the City of Hope approximately $300 million in compensatory damages. On June 24, 2002, the jury voted to award the City of Hope an additional $200 million in punitive damages. Such amounts were accrued as an expense in the second quarter of 2002 and were included in other long-term liabilities. Post-trial proceedings are ongoing. Genentech's motion for judgment notwithstanding the verdict and motion for new trial are scheduled to be heard on August 22, 2002.

On July 24, 2002, Green Equity, LLC filed a shareholder derivative lawsuit in the San Francisco Superior Court against Genentech as nominal defendant and against several members of our Board of Directors (the "individual defendants"). The lawsuit is based upon the claims made by the City of Hope in the contract dispute referred to above. The complaint alleges that the individual defendants breached the fiduciary duty they owe to Genentech by causing us to withhold royalty payments allegedly due to the City of Hope and to conceal third-party licenses that allegedly should have been disclosed to the City of Hope. The plaintiff seeks unspecified damages, costs, and attorneys' fees. The defendants have removed the case to federal court and the case is now pending in the U.S. District Court in the Northern District of California (San Francisco). No answer to the complaint has been filed yet.

On June 7, 2000, Chiron Corporation filed a patent infringement suit against us in the U.S. District Court in the Eastern District of California (Sacramento), alleging that the manufacture, use, sale and offer for sale of our Herceptin antibody product infringes Chiron's U.S. Patent No. 6,054,561. This patent was granted on April 25, 2000, and will expire on June 28, 2005, and it relates to certain antibodies that bind to breast cancer cells and/or other cells. Chiron is seeking compensatory damages for the alleged infringement, additional special damages (e.g., for willful infringement), and attorneys fees and costs. We filed our answer to Chiron's complaint, and in our answer we also stated counterclaims against Chiron. On April 22, 2002, the Court issued its decision ("Markman Order") construing certain aspects of the patent claims that are in dispute. On June 25, 2002, the Court issued several decisions regarding summary judgment motions that previously had been filed by Chiron an d us. In those decisions, the Court ruled as a matter of law that Herceptin infringes claims 1 to 25 of Chiron's patent, and also ruled as a matter of law in favor of Chiron on some but not all of Genentech's defenses and counterclaims regarding the alleged invalidity and/or unenforceability of the patent. The trial of this suit began on August 6, 2002, with jury selection and opening statements. The trial is ongoing. The issues in dispute will be tried and decided separately, beginning with Genentech's remaining defenses and counterclaims regarding the alleged invalidity of the patent, followed if necessary by damages, and then willful infringement. After the jury trial, the Court will conduct further proceedings (if necessary) on Genentech's defense that Chiron's patent is unenforceable based on the doctrine of "prosecution laches." In pre-trial proceedings, Chiron indicated its intention to present evidence in the damages phase of the trial (if such phase is necessary) that compensatory damages for the alleged infringement should equal a royalty in the range of 24% to 31% on Genentech's sales of Herceptin during the term of the patent plus approximately $134 million. Genentech disputes that any royalties are owed on the grounds that the Chiron patent is not infringed, that it is invalid, and that it is unenforceable, and also disputes the amount of compensatory damages for which Chiron has indicated an intention to present evidence in the damages phase of the trial (if such phase is necessary). 

On August 12, 2002, the U.S. Patent and Trademark Office declared an interference between the Chiron patent involved in this lawsuit and a patent application exclusively licensed by Genentech from a university relating to anti-HER2 antibodies. An interference proceeding is declared to decide who first made a particular invention where two or more parties claim the same invention, whether the parties' claims are patentable, and consequently who is entitled to a patent on the invention. In declaring this interference, the Patent Office has determined that there is a substantial question as to whether the inventors of the Chiron patent were first to invent and are entitled to this patent. If the Patent Office were to decide that the inventors of the university's patent application were first to invent and that their claims are patentable, a new patent would issue to them and the Chiron patent would be revoked.


 

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (Continued)

 

On March 13, 2001, Chiron filed another patent infringement lawsuit against us in the U.S. District Court in the Eastern District of California, alleging that the manufacture, use, sale, and/or offer for sale of our Herceptin antibody product infringes Chiron's U.S. Patent No. 4,753,894. Chiron is seeking compensatory damages for the alleged infringement, additional special damages, and attorneys fees and costs. Genentech filed a motion to dismiss this second lawsuit, which was denied. Discovery in this case is currently stayed. The judge has rescheduled the trial of this suit to begin on September 23, 2003. This lawsuit is separate from and in addition to the Chiron suit mentioned above.

We and Pharmacia AB are parties to a 1978 agreement relating to Genentech's development of recombinant human growth hormone products, under which Pharmacia is obligated to pay Genentech royalties on sales of Pharmacia's growth hormone products throughout the world. Pharmacia filed a Request for Arbitration with the International Chamber of Commerce (or ICC) to resolve several disputed issues between Genentech and Pharmacia under the 1978 agreement. One of the claims made by Pharmacia is for a refund of some of the royalties previously paid to Genentech for sales of Pharmacia's growth hormone products in certain countries. On February 14, 2002, the ICC issued a decision in Genentech's favor on that claim, ruling that no refund of royalties is due to Pharmacia. On August 8, 2002, the ICC issued a further decision in Genentech's favor on all remaining claims that had been made by Pharmacia

On March 13, 2001, Genentech filed a complaint in the United States District Court in Delaware against Genzyme Corporation seeking a declaratory judgment that Genentech does not infringe Genzyme's U.S. Patent No. 5,344,773 and that Genentech has not breached a 1992 Patent License and Interference Settlement Agreement between Genentech and Genzyme relating to that patent. Genentech is seeking a declaration that Genzyme's patent is not infringed by any Genentech product, that the patent is invalid, that Genzyme be enjoined from further legal action against Genentech regarding the patent, and that Genentech has not breached the 1992 Agreement. Genzyme has filed its answer to our complaint.

On or about April 6, 2001, Genzyme filed a complaint in the same court against Genentech alleging that our TNKase product infringes the Genzyme patent and that Genentech is in breach of the 1992 Agreement referred to above. Genzyme's complaint also alleges willful infringement and reckless breach of contract by Genentech. Genzyme is seeking to enjoin Genentech from infringing the patent, and is also seeking compensatory damages for the alleged infringement and breach of contract, additional special damages, and attorneys fees and costs. We have filed our answer to Genzyme's complaint. In pre-trial proceedings, Genzyme has indicated its intention to present evidence in the trial that the compensatory damages for the alleged infringement and breach of contract should equal $41.9 million. Genentech disputes that any damages are owed and also disputes the amount of compensatory damages for which Genzyme has indicated an intention to present evidence in the trial. The court has consolidat ed this lawsuit and the declaratory judgment lawsuit referred to above for further proceedings. The trial of this consolidated lawsuit is scheduled to begin on January 21, 2003.

We and Tanox Biosystems, Inc. (or Tanox) are parties to a July 1996 Settlement and Cross-Licensing Agreement relating to the development and manufacture of certain antibody products directed towards immunoglobin E. On February 20, 2002, Tanox filed an amended demand in an ongoing arbitration proceeding between Genentech and Tanox that is being conducted by the American Arbitration Association in San Francisco. In its amended demand, Tanox has claimed breach of the July 1996 Agreement, conversion, tortious interference, unjust enrichment, and unfair competition by Genentech, and requests injunctive relief as well as monetary damages "many times in excess of $100,000,000." On March 14, 2002, Genentech denied all of Tanox's claims, and counterclaimed for breach of contract, theft of trade secrets, misappropriation, breach of confidence, interference with contract, and interference with economic expectancies by Tanox. Genentech requested injunctive relief and monetary damages. The arbitra tion hearing is currently set for December 4, 2002.