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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, 2003

   
 

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
(Registrant's telephone number, including area code)

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

517,848,951 Outstanding at June 30, 2003



 

GENENTECH, INC.
TABLE OF CONTENTS

   

Page No.

 

PART I - FINANCIAL INFORMATION

 

Item 1.

Financial Statements

 

 

Condensed Consolidated Statements of Operations -
for the three and six months ended June 30, 2003 and 2002


3    

 

Condensed Consolidated Statements of Cash Flows -
for the six months ended June 30, 2003 and 2002


4    

 

Condensed Consolidated Balance Sheets -
June 30, 2003 and December 31, 2002


5    

 

Notes to Condensed Consolidated Financial Statements

6-17    

 

Independent Accountants' Review Report

18    

Item 2.

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

19-46    

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

47    

Item 4.

Controls and Procedures

47    

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

48    

Item 4.

Submission of Matters to a Vote of Security Holders

48-49    

Item 6.

Exhibits and Reports on Form 8-K

49    

     

SIGNATURES

50    

 

            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, all of which was redeemed by Roche Holdings, Inc. on June 30, 1999.

            We own or have rights to various copyrights, trademarks and trade names used in our business including the following: Activase® (alteplase, recombinant) tissue-plasminogen activator; Avastin™ (bevacizumab) anti-VEGF antibody; Cathflo® Activase® (alteplase for catheter clearance); Herceptin® (trastuzumab) anti-HER2 antibody; Lucentis™ (ranibizumab, rhuFab V2) anti-VEGF antibody fragment; Nutropin® (somatropin (rDNA origin) for injection) growth hormone; Nutropin AQ® and Nutropin AQ Pen™ (somatropin (rDNA origin) for 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™ (e falizumab, formerly Xanelim™) anti-CD11a antibody. Rituxan® (rituximab) anti-CD20 antibody is a registered trademark of IDEC Pharmaceuticals 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.

 

Page 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,

 

2003

 

2002

 

2003

 

2002

Revenues:

                     

   Product sales (including amounts from related party:
      three months - 2003-$35,775; 2002-$31,318;
      six months - 2003-$65,184; 2002-$52,665)



$



644,324 

 



$



523,527 

 



$



1,242,806 

 



$



1,000,077 

   Royalties (including amounts from related party:
      three months - 2003-$57,577; 2002-$33,425;
      six months - 2003-$104,464; 2002-$59,275)

 



122,786 

   



85,535 

   



236,061 

   



167,378 

   Contract revenue (including amounts from related parties:
      three months - 2003-$18,415; 2002-$4,842;
      six months - 2003-$20,703; 2002-$8,653)

 



32,602 

   



13,181 

   



70,517 

   



22,871 

      Total operating revenues

 

799,712 

   

622,243 

   

1,549,384 

   

1,190,326 

                       

Costs and expenses

                     

   Cost of sales (including amounts for related party:
      three months - 2003-$30,014; 2002-$26,061;
      six months - 2003-$54,843; 2002-$44,884)

 



123,407 

   



106,867 

   



238,249 

   



209,311 

   Research and development (including contract related:
      three months - 2003-$16,980; 2002-$7,126;
      six months - 2003-$26,452; 2002-$11,576)

 



180,203 

   



147,922 

   



337,636 

   



294,613 

   Marketing, general and administrative

 

184,258 

   

125,671 

   

321,480 

   

241,091 

   Collaboration profit sharing

 

107,307 

   

84,090 

   

203,854 

   

156,168 

   Recurring charges related to redemption

 

38,586 

   

38,928 

   

77,172 

   

77,856 

   Special charges:  Litigation-related

 

13,363 

   

518,000 

   

26,608 

   

518,000 

      Total costs and expenses

 

647,124 

   

1,021,478 

   

1,204,999 

   

1,497,039 

                       

Operating margin (loss)

 

152,588 

   

(399,235)

   

344,385 

   

(306,713)

                       

Other income, net

 

40,870 

   

28,825 

   

56,573 

   

65,234 

                       

Income (loss) before taxes

 

193,458 

   

(370,410)

   

400,958 

   

(241,479)

Income tax provision (benefit)

 

61,113 

   

(156,762)

   

117,143 

   

(123,134)

Net income (loss)

$

132,345 

 

$

(213,648)

 

$

283,815 

 

$

(118,345)

                       

Earnings (loss) per share:

                     

   Basic

$

0.26 

 

$

(0.41)

 

$

0.55 

 

$

(0.23)

   Diluted

$

0.25 

 

$

(0.41)

 

$

0.55 

 

$

(0.23)

                       

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

                     

      Basic

 

512,909 

   

520,001 

   

512,398 

   

523,361 

      Diluted

 

522,914 

   

520,001 

   

520,102 

   

523,361 

See Notes to Condensed Consolidated Financial Statements.

 

Page 3


 

GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)


 

Six Months
Ended June 30,

 

2003

 

2002

Cash flows from operating activities:

         

   Net income (loss)

$

283,815 

 

$

(118,345)

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

         

      Depreciation and amortization

 

144,871 

   

136,245 

      Deferred income taxes

 

(30,109)

   

(213,256)

      Gains on sales of securities available-for-sale

 

(19,605)

   

(34,476)

      Losses on sales of securities available-for-sale

 

765 

   

3,775 

      Write-down of securities available-for-sale

 

3,764 

   

9,451 

      Loss on fixed asset dispositions

 

2,408 

   

9,125 

   Changes in assets and liabilities:

         

      Litigation-related liability

 

27,855 

   

518,000 

      Investments in trading securities

 

(17,457)

   

(109,959)

      Other current assets

 

2,618 

   

(40,448)

      Account receivable, trade

 

(28,086)

   

21,803 

      Account receivable, royalties

 

(24,270)

   

10,488 

      Account receivable, other

 

(208,619)

   

(8,084)

      Inventories

 

(28,872)

   

(23,251)

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

 

297,182 

   

28,184 

   Net cash provided by operating activities

 

406,260 

   

189,252 

           

Cash flows from investing activities:

         

   Purchases of securities available-for-sale

 

(575,354)

   

(460,615)

   Proceeds from sales and maturities of securities available-for-sale

 

304,300 

   

768,427 

   Capital expenditures

 

(140,145)

   

(163,816)

   Change in other assets

 

(32,774)

   

(11,632)

   Net cash (used in) provided by investing activities

 

(443,973)

   

132,364 

           

Cash flows from financing activities:

         

   Stock issuances

 

285,333 

   

43,704 

   Stock repurchases

 

(195,274)

   

(491,212)

   Repayment of short-term debt

 

-  

   

(149,692)

   Net cash provided by (used in) financing activities

 

90,059 

   

(597,200)

           

Net increase (decrease) in cash and cash equivalents

 

52,346 

   

(275,584)

   Cash and cash equivalents at beginning of period

 

208,130 

   

395,203 

   Cash and cash equivalents at end of period

$

260,476 

 

$

119,619 

           

   Supplemental cash flow data:

         

      Cash paid during the year for:

         

         Interest

$

-  

 

$

7,482 

         Income taxes paid

 

150,250 

   

86,911 

See Notes to Condensed Consolidated Financial Statements.

 

Page 4


 

GENENTECH, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)


 

June 30,
2003

 

December 31,
2002

Assets:

         

Current assets:

         

   Cash and cash equivalents

$

260,476 

 

$

208,130 

   Short-term investments

 

955,337 

   

826,442 

   Accounts receivable - product sales, net (including amounts due from related party:
      2003-$11,324; 2002-$18,564)

 


270,993 

   


242,907 

   Accounts receivable - royalties, net (including amounts due from related party: 
      2003-$81,164; 2002-$60,615)

 


140,693 

   


116,423 

   Accounts receivable - other, net (including amounts due from related parties:
      2003-$262,564; 2002-$27,715)

 


267,770 

   


59,151 

   Inventories

 

422,414 

   

393,542 

   Prepaid expenses and other current assets

 

234,597 

   

236,189 

      Total current assets

 

2,552,280 

   

2,082,784 

Long-term marketable securities and other

 

785,877 

   

567,286 

Property, plant and equipment (net of accumulated depreciation:
      2003-$771,590; 2002-$727,612)

 


1,146,875 

   


1,068,734 

Goodwill

 

1,334,219 

   

1,334,219 

Other intangible assets (net of accumulated amortization:
      2003-$1,663,817; 2002-$1,578,884)

 


865,719 

   


927,538 

Restricted cash

 

686,600 

   

686,600 

Other long-term assets

 

106,745 

   

110,158 

Total assets

$

7,478,315 

 

$

6,777,319 

           

Liabilities and stockholders' equity:

         

Current liabilities:

         

   Accounts payable

$

69,215 

 

$

51,380 

   Other accrued liabilities (including amounts due to related parties:
      2003-$52,495; 2002-$51,116)

 


529,506 

   


595,280 

      Total current liabilities

 

598,721 

   

646,660 

Litigation-related liabilities

 

580,040 

   

552,185 

Deferred revenue and other long-term liabilities

 

446,621 

   

239,590 

      Total liabilities

 

1,625,382 

   

1,438,435 

           

Commitments and contingencies

         

Stockholders' equity:

         

   Preferred stock

 

-  

   

-  

   Common stock

 

10,357 

   

10,256 

   Additional paid-in capital

 

6,990,075 

   

6,650,352 

   Accumulated deficit, since June 30, 1999

 

(1,431,120)

   

(1,590,366)

   Accumulated other comprehensive income

 

283,621 

   

268,642 

      Total stockholders' equity

 

5,852,933 

   

5,338,884 

Total liabilities and stockholders' equity

$

7,478,315 

 

$

6,777,319 

See Notes to Condensed Consolidated Financial Statements.

 

Page 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, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. The Condensed Consolidated Balance Sheet as of December 31, 2002 has been derived from the audited consolidated financial statements as of that date. For further information, refer to the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2002.

Use of Estimates

            The preparation of financial statements in conformity with generally accepted accounting principles in the United States (or U.S.) 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.

Recent Accounting Pronouncements

            In November 2002, the Emerging Issues Task Force (or EITF) of the Financial Accounting Standards Board (or FASB) issued EITF 00-21, "Revenue Arrangements with Multiple Deliverables," which addresses certain aspects of the accounting for arrangements that involve the delivery or performance of multiple products, services and/or rights to use assets. Under EITF 00-21, revenue arrangements with multiple deliverables should be divided into separate units of accounting if the deliverables meet certain criteria, including whether the fair value of the delivered items can be determined and whether there is evidence of fair value of the undelivered items. In addition, the consideration should be allocated among the separate units of accounting based on their fair values, and the applicable revenue recognition criteria should be considered separately for each of the separate units of accounting. EITF 00-21 is effective for r evenue arrangements we enter into after June 30, 2003. We are currently evaluating the impact of EITF 00-21 on revenue arrangements we enter into in the future, which will need to comply with EITF 00-21.

            In November 2002, the FASB issued Interpretation No. 45 (or FIN 45), "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others." FIN 45 elaborates on the existing disclosure requirements for most guarantees, including residual value guarantees issued in conjunction with operating lease agreements. It also clarifies that at the time a company issues a guarantee, the company must recognize an initial liability for the fair value of the obligation it assumes under that guarantee and must disclose that information in its interim and annual financial statements. The initial recognition and measurement provisions apply on a prospective basis to guarantees issued or modified after December 31, 2002. The disclosure requirements are effective for financial statements of interim or annual periods ending after December 15, 2002. Our adoption of FIN 45 did not have a material impact on our results of operations and financial position. See Note 2, "Leases and Contingencies," below for a discussion of our exposure related to our agreement with Serono S.A. and our synthetic leases and the related residual value guarantees.

 

Page 6


 

            In January 2003, the FASB issued Interpretation No. 46 (or FIN 46), "Consolidation of Variable Interest Entities." FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entity's activities or entitled to receive a majority of the entity's residual returns or both. A variable interest entity is a corporation, partnership, trust, or any other legal structure used for business purposes that either (a) does not have equity investors with voting rights or (b) has equity investors that do not provide sufficient financial resources for the entity to support its activities. A variable interest entity often holds financial assets, including loans or receivables, real estate or other property. A variable interest entity may be essentially passive or it may engage in research and development or other activities on beha lf of another entity. The consolidation requirements of FIN 46 apply to variable interest entities created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. See Note 2, "Leases and Contingencies," below for a discussion of our synthetic leases and the expanded disclosures required by FIN 46.

            In December 2002, the FASB issued Statement No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure." FAS 148 amends FAS 123 "Accounting for Stock-Based Compensation" to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, FAS 148 amends the disclosure requirements of FAS 123 to require more prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. The additional disclosure requirements of FAS 148 are effective for fiscal years ending after December 15, 2002. We have elected to continue to follow the intrinsic value method of accounting as prescribed by Accounting Principles Board Opinion No. 25 (or APB 25), "Accounting for Stock Issued to Employees," t o account for employee stock options. Under APB 25, no compensation expense is recognized unless the exercise price of our employee stock options is less than the market price of the underlying stock on the date of grant. We have not recorded such expense in the periods presented because we grant options at the fair market value of the underlying stock on the date of grant.

            We currently grant options under a stock option plan, which allows for the granting of non-qualified stock options, stock awards and stock appreciation rights to employees, directors and consultants of Genentech. Incentive stock options may only be granted to employees under this plan. Generally, non-qualified options have a maximum term of 10 years. Incentive options have a maximum term of 10 years. In general, options vest in increments over four years from the date of grant, although we may grant options with different vesting terms from time to time. No stock appreciation rights or incentive stock options have been granted under our current plan to date.

            We have an employee stock plan that allows eligible employees to purchase Common Stock at 85% of the lower of the fair market value of the Common Stock on the grant date or the fair market value on the first business day of each calendar quarter. Purchases are limited to 15% of each employee's eligible compensation. All full-time employees of Genentech are eligible to participate in this plan.

            The following information regarding net income (loss) and earnings (loss) per share has been determined as if we had accounted for our employee stock options and employee stock plan under the fair value method prescribed by FAS 123. The resulting effect on net income (loss) and earnings (loss) per share pursuant to FAS 123 is not likely to be representative of the effects in future periods, due to subsequent additional option grants and periods of vesting. The fair value of options was estimated at the date of grant using a Black-Scholes option valuation model with the following weighted-average assumptions:

 

Three Months
Ended June 30,

 

Six Months
Ended June 30,

 

2003

 

2002

 

2003

 

2002

Risk-free interest rate

2.0%  

 

4.3%  

 

2.3%  

 

4.3%  

Dividend yield

0.0%  

 

0.0%  

 

0.0%  

 

0.0%  

Volatility factors of the expected market price of
   our Common Stock


45.0%  

 


43.0%  

 


40.8%  

 


43.0%  

Weighted-average expected life of option (years)

5     

 

5     

 

5     

 

5     

 

Page 7


 

            The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. Option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because our employee stock options have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not provide a reliable single measure of the fair value of our employee stock options.

            For purposes of disclosures pursuant to FAS 123 as amended by FAS 148, the estimated fair value of options is amortized to expense ratably over the options' vesting period.

            The following table illustrates the effect on reported net income (loss) and earnings (loss) per share as if we had applied the fair value recognition provisions of FAS 123 to stock-based employee compensation (in thousands, except per share amounts):

 

Three Months
Ended June 30,

 

Six Months
Ended June 30,

 

2003

 

2002

 

2003

 

2002

Net income (loss) - as reported

$

132,345 

 

$

(213,648)

 

$

283,815 

 

$

(118,345)

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

 



40,440 

   



44,274 

   



81,431 

   



88,942 

Pro forma net income (loss)

$

91,905 

 

$

(257,922)

 

$

202,384 

 

$

(207,287)