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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 September 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

1,049,621,719 Outstanding at October 22, 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 nine months ended September 30, 2004 and 2003


3    

 

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


4    

 

Condensed Consolidated Balance Sheets -
September 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

20-55    

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

56    

Item 4.

Controls and Procedures

56    

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

57    

Item 2.

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

57    

     

Item 6.

Exhibits

58    

     

SIGNATURES

59    


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) anti-CD11a antibody; and TNKase™ (tenecteplase) single-bolus thrombo lytic 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 September 30,

 

Nine Months
Ended September 30,

 

2004

 

2003

 

2004

 

2003

Revenues

                     

   Product sales (including amounts from related parties:
      three months - 2004-$23,855; 2003-$18,040;
      nine months - 2004-$79,347; 2003-$83,224)



$



1,005,511 

 



$



654,948 

 



$



2,682,577 

 



$



1,897,754 

   Royalties (including amounts from related party:
      three months - 2004-$83,099; 2003-$59,912;
      nine months - 2004-$238,468; 2003-$164,376)

 



153,942 

   



116,535 

   



459,899 

   



352,597 

   Contract revenue (including amounts from related parties:
      three months - 2004-$15,271; 2003-$31,332;
      nine months - 2004-$85,783; 2003-$52,035)

 



43,191 

   



45,561 

   



163,381 

   



116,078 

           Total operating revenues

 

1,202,644 

   

817,044 

   

3,305,857 

   

2,366,429 

Costs and expenses

                     

   Cost of sales (including amounts for related parties:
      three months - 2004-$22,529; 2003-$20,517;
      nine months - 2004-$71,194; 2003-$75,360)

 



165,990 

   



115,673 

   



467,153 

   



353,921 

   Research and development
      (including amounts for related parties:
      three months - 2004-$36,870; 2003-$36,377;
      nine months - 2004-$124,072; 2003-$59,860)
      (including contract related:
      three months - 2004-$18,673; 2003-$29,660;
      nine months - 2004-$90,168; 2003-$56,112)

 







234,086 

   







168,707 

   







637,317 

   







506,343 

   Marketing, general and administrative

 

264,648 

   

209,860 

   

788,616 

   

531,340 

   Collaboration profit sharing (including amounts for related party:
      three months - 2004-$21,560; 2003-$0;
      nine months - 2004-$48,209; 2003-$0)

 



151,894 

   



119,676 

   



423,546 

   



323,530 

   Recurring charges related to redemption

 

34,534 

   

38,586 

   

110,952 

   

115,758 

   Special items:  litigation-related

 

13,419 

   

(131,617)

   

40,276 

   

(105,008)

           Total costs and expenses

 

864,571 

   

520,885 

   

2,467,860 

   

1,725,884 

Operating margin

 

338,073 

   

296,159 

   

837,997 

   

640,545 

Other income, net

 

23,510 

   

15,884 

   

61,274 

   

72,456 

Income before taxes and cumulative effect of accounting change

361,583 

312,043 

899,271 

713,001 

Income tax provision

 

130,709 

   

112,407 

   

321,040 

   

229,549 

Income before cumulative effect of accounting change

 

230,874 

   

199,636 

   

578,231 

   

483,452 

Cumulative effect of accounting change, net of tax

 

   

(47,655)

   

   

(47,655)

Net income

$

230,874 

 

$

151,981 

 

$

578,231 

 

$

435,797 

Earnings per share

                     

   Basic

                     

      Earnings before cumulative effect of accounting change

$

0.22 

 

$

0.19 

 

$

0.55 

 

$

0.47 

      Cumulative effect of accounting change, net of tax

 

   

(0.04)

   

   

(0.05)

      Net earnings per share

$

0.22 

 

$

0.15 

 

$

0.55 

 

$

0.42 

   Diluted

                     

      Earnings before cumulative effect of accounting change

$

0.21 

 

$

0.18 

 

$

0.53 

 

$

0.46 

      Cumulative effect of accounting change, net of tax

 

   

(0.04)

   

   

(0.05)

      Net earnings per share

$

0.21 

 

$

0.14 

 

$

0.53 

 

$

0.41 

Weighted-average shares used to compute earnings per share

                     

   Basic

 

1,055,140 

   

1,040,762 

   

1,057,006 

   

1,030,140 

   Diluted

 

1,077,093 

   

1,065,572 

   

1,082,081 

   

1,051,649 

See Notes to Condensed Consolidated Financial Statements

 

Page 3


 

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


 

Nine Months
Ended September 30,

 

2004

 

2003

Cash flows from operating activities

         

   Net income

$

578,231 

 

$

435,797 

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

         

      Cumulative effect of accounting change, net of tax

 

   

47,655 

      Depreciation and amortization

 

259,583 

   

220,926 

      Deferred income taxes

 

(60,325)

   

(156,918)

      Deferred revenue

 

(6,250)

   

251,851 

      Litigation-related liabilities

 

38,568 

   

42,964 

      Tax benefit from employee stock options

 

274,918 

   

202,528 

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

 

(11,736)

   

(17,797)

      Write-down of securities available-for-sale

 

12,033 

   

3,764 

      Loss on fixed asset dispositions

 

   

8,914 

   Changes in assets and liabilities:

         

      Receivables and other current assets

 

(274,416)

   

(73,878)

      Inventories

 

(90,280)

   

(47,063)

      Investments in trading securities

 

(38,021)

   

(26,701)

      Accounts and taxes payables and other current liabilities

 

170,375 

   

100,695 

   Net cash provided by operating activities

 

852,680 

   

992,737 

           

Cash flows from investing activities

         

   Purchases of securities available-for-sale

 

(825,950)

   

(1,168,001)

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

 

772,058 

   

398,045 

   Capital expenditures

 

(418,214)

   

(211,245)

   Change in other assets

 

(34,297) 

   

(41,308)

   Transfer from restricted cash, net

 

4,600 

   

   Net cash used in investing activities

 

(501,803)

   

(1,022,509)

           

Cash flows from financing activities

         

   Stock issuances

 

421,093 

   

431,606 

   Stock repurchases

 

(821,354)

   

(195,274)

   Net cash (used in) provided by financing activities

 

(400,261)

   

236,332 

           

Net (decrease) increase in cash and cash equivalents

 

(49,384)

   

206,560 

   Cash and cash equivalents at beginning of period

 

372,152 

   

208,130 

   Cash and cash equivalents at end of period

$

322,768 

 

$

414,690 

See Notes to Condensed Consolidated Financial Statements.

 

Page 4


 

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

 

September 30,
2004

 

December 31,
2003

Assets

         

Current assets

         

   Cash and cash equivalents

$

322,768 

 

$

372,152 

   Short-term investments

 

1,437,396 

   

1,139,620 

   Accounts receivable - product sales, net (including amounts from related parties:
      2004-$7,293; 2003-$16,018)

 


570,353 

   


315,097 

   Accounts receivable - royalties, net (including amounts from related party:
      2004-$117,799; 2003-$113,739)

 


193,650 

   


184,163 

   Accounts receivable - other, net (including amounts from related parties:
      2004-$66,442; 2003-$71,863)

 


88,899 

   


74,831 

   Inventories

 

559,920 

   

469,640 

   Prepaid expenses and other current assets

 

203,481 

   

201,327 

      Total current assets

 

3,376,467 

   

2,756,830 

Long-term marketable debt and equity securities

 

1,310,422 

   

1,422,886 

Property, plant and equipment

 

1,922,313 

   

1,617,912 

Goodwill

 

1,315,019 

   

1,315,019 

Other intangible assets

 

677,049 

   

810,810 

Restricted cash and other long-term assets

 

776,576 

   

812,714 

Total assets

$

9,377,846 

 

$

8,736,171 

           

Liabilities and stockholders' equity

         

Current liabilities

         

   Accounts payable

$

60,081 

 

$

59,700 

   Taxes payable

 

172,136 

   

88,988 

   Other current liabilities (including amounts owed to related parties:
      2004-$94,950; 2003-$58,138)

 


848,825 

   


724,343 

      Total current liabilities

 

1,081,042 

   

873,031 

Long-term debt

 

412,250 

   

412,250 

Other long-term liabilities

 

916,988 

   

930,592 

      Total liabilities

 

2,410,280 

   

2,215,873 

           

Commitments and contingencies

         

Stockholders' equity

         

   Common stock

 

21,088 

   

20,990 

   Additional paid-in capital

 

7,945,843 

   

7,359,416 

   Accumulated deficit, since June 30, 1999

 

(1,290,777)

   

(1,157,141)

   Accumulated other comprehensive income

 

291,412 

   

297,033 

      Total stockholders' equity

 

6,967,566 

   

6,520,298 

Total liabilities and stockholders' equity

$

9,377,846 

 

$

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 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.

All information in this report 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 stock split of our common stock.

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. 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. 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 val ue 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 employee stock plan.

We had stock option exercises of 1.8 million shares in the third quarter and 18.3 million shares in the first nine 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 September 30,

 

Nine Months
Ended September 30,

 

2004

 

2003

 

2004

 

2003

Risk-free interest rate

3.4%  

 

2.8%  

 

3.4%  

 

2.8%  

Dividend yield

0.0%  

 

0.0%  

 

0.0%  

 

0.0%  

Volatility factors of the expected market price of our Common Stock

43.0%  

 

45.0%  

 

43.0%  

 

44.7%  

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. 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.

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 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 September 30,

 

Nine Months
Ended September 30,

 

2004

 

2003

 

2004

 

2003

Net income - as reported

$

230,874 

 

$

151,981 

 

$

578,231 

 

$

435,797 

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

 



46,282 

   



44,096 

   



136,148 

   



123,781 

Pro forma net income

$

184,592 

 

$

107,885 

 

$

442,083&nbs