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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, 2004

   
 

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

1,054,316,254 Outstanding at July 23, 2004

 


 

GENENTECH, INC.
TABLE OF CONTENTS

   

Page No.

 

PART I - FINANCIAL INFORMATION

 

Item 1.

Financial Statements

3    

 

Condensed Consolidated Statements of Income -
for the three and six months ended June 30, 2004 and 2003


3    

 

Condensed Consolidated Statements of Cash Flows -
for the six months ended June 30, 2004 and 2003


4    

 

Condensed Consolidated Balance Sheets -
June 30, 2004 and December 31, 2003


5    

 

Notes to Condensed Consolidated Financial Statements

6-18    

 

Report of Independent Registered Public Accounting Firm

19    

Item 2.

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

20-53    

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

54    

Item 4.

Controls and Procedures

54    

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

55    

Item 2.

Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities

55    

     

Item 4.

Submission of Matters to a Vote of Security Holders

56    

     

Item 6.

Exhibits and Reports on Form 8-K

57    

     

SIGNATURES

58    


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, "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. All information relating to the number of shares, price per share and per share amounts of common stock give effect to the May 2004 two-for-one split of our common stock.

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; Omnitarg™ (pertuzumab) HER dimerization inhibitor; Protropin® (somatrem for injection) growth hormone; Pulmozyme® (dornase alfa, recombinant) inhalation solution; Raptiva™ (efalizumab, formerly Xanelim™) anti-CD11a antibody; and TNKase™ (tenecte plase) single-bolus thrombolytic agent. Rituxan® (rituximab) anti-CD20 antibody is a registered trademark of Biogen Idec Inc.; Tarceva™ (erlotinib HC1) 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 INCOME

(In thousands, except per share amounts)
(Unaudited)

 

Three Months
Ended June 30,

 

Six Months
Ended June 30,

 

2004

 

2003

 

2004

 

2003

Revenues

                     

   Product sales (including amounts from related parties:
      three months - 2004-$27,668; 2003-$35,775;
      six months - 2004-$55,492; 2003-$65,184)



$



913,366 

 



$



644,324 

 



$



1,677,066 

 



$



1,242,806

   Royalties (including amounts from related party:
      three months - 2004-$84,071; 2003-$57,577;
      six months - 2004-$155,368; 2003-$104,464)

 



151,860 

   



122,786 

   



305,957 

   



236,061 

   Contract revenue (including amounts from related parties:
      three months - 2004-$33,891; 2003-$18,415;
      six months - 2004-$70,512; 2003-$20,703)

 



62,852 

   



32,602 

   



120,190 

   



70,517 

           Total operating revenues

 

1,128,078 

   

799,712 

   

2,103,213 

   

1,549,384 

Costs and expenses

                     

   Cost of sales (including amounts for related parties:
      three months - 2004-$26,019; 2003-$30,014;
      six months - 2004-$48,664; 2003-$54,843)

 



186,683 

   



123,407 

   



301,163 

   



238,249 

   Research and development
      (including amounts for related parties:
      three months - 2004-$40,738; 2003-$11,354;
      six months - 2004-$87,202; 2003-$23,483)
      (including contract related:
      three months - 2004-$34,571; 2003-$16,980;
      six months - 2004-$71,495; 2003-$26,452)

 







212,886 

   







180,203 

   







403,231 

   







337,636 

   Marketing, general and administrative

 

276,654 

   

184,258 

   

523,968 

   

321,480 

   Collaboration profit sharing (including amounts for related party:
      three months - 2004-$14,827; 2003-$0;
      six months - 2004-$26,649; 2003-$0)

 



145,221 

   



107,307 

   



271,652 

   



203,854

   Recurring charges related to redemption

 

38,209 

   

38,586 

   

76,418 

   

77,172 

   Special charges:  litigation-related

 

13,458 

   

13,363 

   

26,857 

   

26,608 

           Total costs and expenses

 

873,111 

   

647,124 

   

1,603,289 

   

1,204,999 

Operating margin

 

254,967 

   

152,588 

   

499,924 

   

344,385 

Other income, net

 

15,444 

   

40,870 

   

37,765 

   

56,573 

Income before taxes

270,411 

193,458 

537,689 

400,958 

Income tax provision

 

99,640 

   

61,113 

   

190,331 

   

117,143 

Net income

$

170,771 

 

$

132,345 

 

$

347,358 

 

$

283,815 

Earnings per share

                     

   Basic

$

0.16 

 

$

0.13 

 

$

0.33 

 

$

0.28 

   Diluted

$

0.16 

 

$

0.13 

 

$

0.32 

 

$

0.27 

Weighted-average shares used to compute earnings per share

                     

   Basic

 

1,060,619 

   

1,025,818 

   

1,057,955 

   

1,024,796 

   Diluted

 

1,087,087 

   

1,045,829 

   

1,084,618 

   

1,040,204 

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,

 

2004

 

2003

Cash flows from operating activities

         

   Net income

$

347,358 

 

$

283,815 

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

         

      Depreciation and amortization

 

178,516 

   

144,871 

      Deferred income taxes

 

(17,715)

   

(30,109)

      Deferred revenue

 

(18,846)

   

247,363 

      Litigation-related liabilities

 

25,712 

   

27,855 

      Tax benefit from employee stock options

 

231,305 

   

125,197 

      Net gain on sales of securities available-for-sale and other

 

(605)

   

(18,840)

      Write-down of securities available-for-sale

 

   

3,764 

      Loss on fixed asset dispositions

 

   

2,408 

   Changes in assets and liabilities:

         

      Receivables and other current assets

 

(157,758)

   

(258,357)

      Inventories

 

(58,009)

   

(28,872)

      Investments in trading securities

 

(28,496)

   

(17,457)

      Accounts payable and other current liabilities

 

(64,447)

   

(75,378)

   Net cash provided by operating activities

 

437,015 

   

406,260 

           

Cash flows from investing activities

         

   Purchases of securities available-for-sale

 

(684,109)

   

(575,354)

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

 

624,227 

   

304,300 

   Capital expenditures

 

(196,633)

   

(140,145)

   Change in other assets

 

(28,933)

   

(32,774)

   Transfer to restricted cash

 

(52,000)

   

   Net cash used in investing activities

 

(337,448)

   

(443,973)

           

Cash flows from financing activities

         

   Stock issuances

 

366,737 

   

285,333 

   Stock repurchases

 

(575,749)

   

(195,274)

   Net cash (used in) provided by financing activities

 

(209,012)

   

90,059 

           

Net (decrease) increase in cash and cash equivalents

 

(109,445)

   

52,346 

   Cash and cash equivalents at beginning of period

 

372,152 

   

208,130 

   Cash and cash equivalents at end of period

$

262,707 

 

$

260,476 

See Notes to Condensed Consolidated Financial Statements.

 

Page 4


 

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

 

June 30,
2004

 

December 31,
2003

Assets

         

Current assets

         

   Cash and cash equivalents

$

262,707 

 

$

372,152 

   Short-term investments

 

1,356,427 

   

1,139,620 

   Accounts receivable - product sales, net (including amounts from related parties:
      2004-$7,118; 2003-$16,018)

 


464,032 

   


315,097 

   Accounts receivable - royalties, net (including amounts from related party:
      2004-$114,760; 2003-$113,739)

 


189,513 

   


184,163 

   Accounts receivable - other, net (including amounts from related parties:
      2004-$94,563; 2003-$71,863)

 


88,901 

   


74,831 

   Inventories

 

527,649 

   

469,640 

   Prepaid expenses and other current assets

 

167,155 

   

201,327 

      Total current assets

 

3,056,384 

   

2,756,830 

Long-term marketable debt and equity securities

 

1,414,663 

   

1,422,886 

Property, plant and equipment

 

1,740,423 

   

1,617,912 

Goodwill

 

1,315,019 

   

1,315,019 

Other intangible assets

 

710,644 

   

810,810 

Restricted cash and other long-term assets

 

817,906 

   

812,714 

Total assets

$

9,055,039 

 

$

8,736,171 

           

Liabilities and stockholders' equity

         

Current liabilities

         

   Accounts payable

$

30,326 

 

$

59,700 

   Other current liabilities (including amounts owed to related parties:
      2004-$84,723; 2003-$58,138)

 


806,550 

   


813,331 

      Total current liabilities

 

836,876 

   

873,031 

Long-term debt

 

412,250 

   

412,250 

Other long-term liabilities

 

920,879 

   

930,592 

      Total liabilities

 

2,170,005 

   

2,215,873 

           

Commitments and contingencies

         

Stockholders' equity

         

   Preferred stock

 

   

   Common stock

 

21,141 

   

10,495 

   Additional paid-in capital

 

7,848,238 

   

7,370,261 

   Accumulated deficit, since June 30, 1999

 

(1,276,462)

   

(1,157,491)

   Accumulated other comprehensive income

 

292,117 

   

297,033 

      Total stockholders' equity

 

6,885,034 

   

6,520,298 

Total liabilities and stockholders' equity

$

9,055,039 

 

$

8,736,171 

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

We prepared the condensed consolidated financial statements following the requirements of the Securities and Exchange Commission (or SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by accounting principles generally accepted in the United States of America (or GAAP) can be condensed or omitted. In the opinion of management, the financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of our financial position and operating results. Certain reclassifications have been made to prior year amounts to conform with current period presentation.

Revenues, expenses, assets and liabilities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be the same as those for the full year. The information included in this quarterly report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2003.

In February 2004, the Board approved a two-for-one stock split of our common stock in the form of a stock dividend of one share of Genentech common stock for each share held contingent on stockholder approval of an increase in our authorized common stock. On April 16, 2004, at our annual meeting of stockholders, our stockholders approved an increase in our authorized common stock. The record date for the stock split was April 28, 2004. Our stock began trading on a split-adjusted basis on May 13, 2004. All information in this report relating to the number of shares, price per share and per share amounts of common stock are presented on a post-split basis.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Genentech and all subsidiaries. Genentech also consolidates a variable interest entity for which Genentech is the primary beneficiary pursuant to Financial Accounting Standards Board (or FASB) Interpretation No. 46R (or FIN 46R), a revision to Interpretation 46, "Consolidation of Variable Interest Entities," an interpretation of Accounting Research Bulletin No. 51, and records the noncontrolling interest in the condensed consolidated balance sheet. Material intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of financial statements in conformity with GAAP 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.

Accounting for Stock-Based Compensation

We have elected to continue to follow the intrinsic value method of accounting for stock-based compensation as prescribed by Accounting Principles Board Opinion No. 25 (or APB 25), "Accounting for Stock Issued to Employees." We apply the disclosure provisions of Statement of Financial Accounting Standards No. 123 (or FAS 123), "Accounting for Stock-based Compensation," as amended by FAS 148, "Accounting for Stock-based Compensation - Transition and Disclosure" (or FAS 148) as if the fair value-based method had been applied in measuring compensation expense. Under APB 25, we do not recognize compensation expense 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 grant all of our options at the fair market value of the underlying stock on the date of grant. Consequently, we have not recorded such expense in the periods presented.

 

Page 6


 

We currently grant options under a stock option plan that allows for the granting of non-qualified stock options, incentive stock options and stock purchase rights to employees, directors and consultants of Genentech. Incentive stock options may only be granted to employees under this plan. Generally, non-qualified options and incentive options have a maximum term of 10 years. In general, options vest in increments over four years from the date of grant. We have an employee stock plan that allows eligible employees to purchase common stock at 85% of the lower of the fair market value on the grant date or the fair market value on the purchase date. Purchases are limited to 15% of each employee's eligible compensation and subject to certain Internal Revenue Service restrictions. All full-time employees of Genentech are eligible to participate in this plan.

We had stock option exercises of 5.3 million shares in the second quarter and 16.6 million shares in the first six months of 2004.

The following information regarding net income and earnings 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 as amended by FAS 148. The resulting effect on net income and earnings 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,

 

2004

 

2003

 

2004

 

2003

Risk-free interest rate

3.7%  

 

2.0%  

 

3.6%  

 

2.3%  

Dividend yield

0.0%  

 

0.0%  

 

0.0%  

 

0.0%  

Volatility factors of the expected market price of
   our Common Stock


42.0%  

 


45.0%  

 


43.0%  

 


40.8%  

Weighted-average expected life of option (years)

5     

 

5     

 

5     

 

5     

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, thus these calculations may not accurately value such 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.

 

Page 7


 

The following table illustrates the effect on reported net income and earnings 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,

 

2004

 

2003

 

2004

 

2003

Net income - as reported

$

170,771 

 

$

132,345 

 

$

347,358 

 

$

283,815 

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

 



45,611 

   



41,223 

   



90,316 

   



81,431 

Pro forma net income

$

125,160 

 

$

91,122 

 

$

257,042 

 

$

202,384 

Earnings per share:

                     

   Basic-as reported

$

0.16 

 

$

0.13 

 

$

0.33 

 

$

0.28