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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 March 31, 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

531,789,029 Outstanding at April 28, 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 months ended March 31, 2004 and 2003


3    

 

Condensed Consolidated Statements of Cash Flows -
for the three months ended March 31, 2004 and 2003


4    

 

Condensed Consolidated Balance Sheets -
March 31, 2004 and December 31, 2003


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

19-48    

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

49    

Item 4.

Controls and Procedures

49    

 

PART II - OTHER INFORMATION

 

Item 1.

Legal Proceedings

50    

Item 6.

Exhibits and Reports on Form 8-K

50    

     

SIGNATURES

51    


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.

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 March 31,

 

2004

 

2003

Revenues

         

   Product sales (including amounts from related parties:
      2004-$27,824; 2003-$29,409)


$


763,700 

 


$


598,482 

   Royalties (including amounts from related party:
      2004-$71,297; 2003-$46,887)

 


154,097 

   


113,275 

   Contract revenue (including amounts from related parties:
      2004-$36,621; 2003-$2,288)

 


57,338 

   


37,915 

           Total operating revenues

 

975,135 

   

749,672 

Costs and expenses

         

   Cost of sales (including amounts for related parties:
      2004-$22,645; 2003-$24,829)

 


114,480 

   


114,842 

   Research and development
      (including related parties amounts of: 2004-$46,464; 2003-$12,129)
      (including contract related: 2004-$36,924; 2003-$9,473)

 



190,345 

   



157,433 

   Marketing, general and administrative

 

247,314 

   

137,222 

   Collaboration profit sharing (including related party amounts of:
      2004-$11,822; 2003-$0)

 


126,431 

   


96,547 

   Recurring charges related to redemption

 

38,209 

   

38,586 

   Special charges:  litigation-related

 

13,399 

   

13,245 

           Total costs and expenses

 

730,178 

   

557,875 

Operating margin

 

244,957 

   

191,797 

Other income, net

 

22,321 

   

15,703 

Income before taxes

267,278 

207,500 

Income tax provision

 

90,691 

   

56,029 

Net income

$

176,587 

 

$

151,471 

Earnings per share

         

   Basic

$

0.33 

 

$

0.30 

   Diluted

$

0.33 

 

$

0.29 

Weighted-average shares used to compute earnings per share

         

   Basic

 

527,599 

   

511,909 

   Diluted

 

540,814 

   

517,266 

See Notes to Condensed Consolidated Financial Statements.

 

Page 3


 

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


 

Three Months
Ended March 31,

 

2004

 

2003

Cash flows from operating activities

         

   Net income

$

176,587 

 

$

151,471 

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

         

      Depreciation and amortization

 

78,975 

   

73,016 

      Deferred income taxes

 

(14,842)

   

(17,889)

      Deferred revenue

 

(12,570)

   

5,047 

      Litigation-related liabilities

 

12,856 

   

15,077 

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

 

(649)

   

(369)

      Write-down of securities available-for-sale

 

   

3,764 

   Changes in assets and liabilities:

         

      Receivables and other current assets

 

(31,651)

   

27,205 

      Inventories

 

(55,089)

   

(17,565)

      Investments in trading securities

 

(6,781)

   

11,148 

      Accounts payable and other current liabilities

 

(50,406)

   

(5,406)

   Net cash provided by operating activities

 

96,430 

   

245,499 

           

Cash flows from investing activities

         

   Purchases of securities available-for-sale

 

(452,150)

   

(253,742)

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

 

172,845 

   

120,699 

   Capital expenditures

 

(97,707)

   

(73,460)

   Change in other assets

 

10,075 

   

(6,317)

   Net cash used in investing activities

 

(366,937)

   

(212,820)

           

Cash flows from financing activities

         

   Stock issuances

 

231,552 

   

21,064 

   Stock repurchases

 

   

(113,172)

   Net cash provided by (used in) financing activities

 

231,552 

   

(92,108)

           

Net decrease in cash and cash equivalents

 

(38,955)

   

(59,429)

   Cash and cash equivalents at beginning of period

 

372,152 

   

208,130 

   Cash and cash equivalents at end of period

$

333,197 

 

$

148,701 

See Notes to Condensed Consolidated Financial Statements.

 

Page 4


 

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

 

March 31,
2004

 

December 31,
2003

Assets

         

Current assets

         

   Cash and cash equivalents

$

333,197 

 

$

372,152 

   Short-term investments

 

1,304,624 

   

1,139,620 

   Accounts receivable - product sales, net (including amounts from related parties:
      2004-$12,871; 2003-$16,018)

 


379,492 

   


315,097 

   Accounts receivable - royalties, net (including amounts from related party:
      2004-$100,635; 2003-$113,739)

 


174,497 

   


184,163 

   Accounts receivable - other, net (including amounts from related parties:
      2004-$65,531; 2003-$71,863)

 


56,815 

   


74,831 

   Inventories

 

524,729 

   

469,640 

   Prepaid expenses and other current assets

 

176,912 

   

201,327 

      Total current assets

 

2,950,266 

   

2,756,830 

Long-term marketable debt and equity securities

 

1,654,985 

   

1,422,886 

Property, plant and equipment (net of accumulated depreciation of:
      2004-$918,978; 2003-$883,556)

 


1,679,549 

   


1,617,912 

Goodwill

 

1,315,019 

   

1,315,019 

Other intangible assets (net of accumulated amortization of:
      2004-$1,792,217; 2003-$1,749,234)

 


765,415 

   


810,810 

Restricted cash and other long-term assets

 

769,221 

   

812,714 

Total assets

$

9,134,455 

 

$

8,736,171 

Liabilities and stockholders' equity

         

Current liabilities

         

   Accounts payable

$

24,296 

 

$

59,700 

   Other current liabilities (including amounts owed to related parties:
      2004-$54,939; 2003-$58,138)

 


663,312 

   


813,331 

      Total current liabilities

 

687,608 

   

873,031 

Long-term debt

 

412,250 

   

412,250 

Other long-term liabilities

 

927,347 

   

930,592 

      Total liabilities

 

2,027,205 

   

2,215,873 

Commitments and contingencies

         

Stockholders' equity

         

   Preferred stock

 

   

   Common stock

 

10,612 

   

10,495 

   Additional paid-in capital

 

7,751,394 

   

7,370,261 

   Accumulated deficit, since June 30, 1999

 

(980,904)

   

(1,157,491)

   Accumulated other comprehensive income

 

326,148 

   

297,033 

      Total stockholders' equity

 

7,107,250 

   

6,520,298 

Total liabilities and stockholders' equity

$

9,134,455 

 

$

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.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Genentech and all subsidiaries. Genentech also consolidated a variable interest entity in 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 recorded 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.

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

 

Page 6


 

grant, although we may grant options with different vesting terms from time to time. No stock purchase 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 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.

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 March 31,

 

2004

 

2003

Risk-free interest rate

3.0 %

 

2.8 %

Dividend yield

0.0 %

 

0.0 %

Volatility factors of the expected market price of our Common Stock

45.0 %

 

36.0 %

Weighted-average expected life of option (years)

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.

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 March 31,

 

2004

 

2003

Net income as reported

$

176,587 

 

$

151,471 

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

 



45,883 

   



40,208 

Pro forma net income

$

130,704 

 

$

111,263 

           

Earnings per share:

         

   Basic-as reported

$

0.33 

 

$

0.30 

   Basic-pro forma

$

0.25 

 

$

0.22 

           

   Diluted-as reported

$

0.33 

 

$

0.29 

   Diluted-pro forma

$

0.24 

 

$

0.22 

 

Page 7


 

On March 31, 2004, the FASB issued an Exposure Draft (ED), "Share-Based Payment - An Amendment of FASB Statements No. 123 and 95." The proposed Statement addresses the accounting for transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise's equity instruments or that may be settled by the issuance of such equity instruments. The proposed Statement would eliminate the ability to account for share-based compensation transactions using APB 25, and generally would require instead that such transactions be accounted for using a fair-value based method. As proposed, companies would be required to recognize an expense for compensation cost related to share-based payment arrangements including stock options and employee stock purchase plans. As proposed, the new rules would be applied on a modified prospective basis as defined in the ED, and would be effective f or public companies for fiscal years beginning after December 15, 2004. We are currently evaluating option valuation methodologies and assumptions in light of the evolving accounting standards related to employee stock options. Current estimates of option values using the Black Scholes method (as shown above) may not be indicative of results from valuation methodologies ultimately adopted in the final rules.

Note 2.

LEASES AND CONTINGENCIES

Leases

We lease various real properties under operating leases. Three of our operating leases are commonly referred to as "synthetic leases." Under FIN 46R, each synthetic lease is evaluated to determine if it qualifies as a variable interest entity (or VIE) and whether Genentech is the primary beneficiary under which it would be required to consolidate the VIE.

The most significant of our synthetic leases relates to our manufacturing facility located in Vacaville, California. Under FIN 46R, we determined that the entity from which we lease the Vacaville facility qualified as a VIE and that we are the primary beneficiary of this VIE as we absorb the majority of the entity's expected losses. Upon adoption of the provisions of FIN 46R on July 1, 2003, we consolidated the entity.

Our two remaining leases were entered into with BNP Paribas Leasing Corporation (or BNP), who leases directly to us various buildings that we occupy in South San Francisco, California. Under one of these leases, we are required to maintain cash collateral of $56.6 million, which we have included in our condensed consolidated balance sheets as restricted cash and other long-term assets. We have evaluated our accounting for these leases under the provisions of FIN 46R, and we determined that, as of July 1, 2003 and through March 31, 2004, we are not required to consolidate either the leasing entity or the specific assets that we lease under the BNP leases.

Future minimum lease payments were computed based on December 31, 2003 market-based interest rates, which are subject to fluctuations. The minimum payments under all leases, exclusive of the residual value guarantees, executory costs and sublease income, at December 31, 2003, are as follows (in millions):

 

2004

 

2005

 

2006

 

2007

 

2008

 

Thereafter

 

Total

Vacaville synthetic lease(1)

$

6.2 

 

$

6.2 

 

$

5.6 

 

$

 

$

 

$

 

$

18.0 

South San Francisco
   synthetic leases

 


2.7 

   


2.6 

   


1.1 

   


- - 

   


- - 

   


- - 

   


6.4 

Other operating leases

 

6.5 

   

6.9 

   

5.8 

   

5.8 

   

5.8 

   

24.1 

   

54.9 

     Total

$

15.4 

 

$

15.7 

 

$

12.5 

 

$

5.8 

 

$

5.8 

 

$

24.1 

 

$

79.3 

___________

(1)

Represents a VIE, which we consolidated effective July 1, 2003, as we are the primary beneficiary of this VIE.

 

Page 8


 

The following summarizes the approximate initial fair values of the facilities at the inception of the related leases, lease terms and residual value guarantee amounts for each of our synthetic leases (in millions):

 

Approximate
Initial Fair
Value of
Leased Property

 



Lease
Expiration

 

Maximum
Residual
Value
Guarantee

Vacaville lease

 

$

425.0 

       

11/2006 

     

$

371.8 

 

South San Francisco lease 1

   

56.6 

       

07/2004 

       

48.1 

 

South San Francisco lease 2

   

160.0 

       

06/2007 

       

136.0 

 

      Total

 

$

641.6 

               

$

555.9