-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, J5nSVglbHr8Vm9O/IEAn81xodHeZvOlygDkZmjSGxuK3p5Q07DzVAN5/6Af62lx2 FSNLjumuOcEeUSCmfRM4/Q== 0000318771-04-000003.txt : 20040407 0000318771-04-000003.hdr.sgml : 20040407 20040407160345 ACCESSION NUMBER: 0000318771-04-000003 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040407 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040407 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENENTECH INC CENTRAL INDEX KEY: 0000318771 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 942347624 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09813 FILM NUMBER: 04722497 BUSINESS ADDRESS: STREET 1: 1 DNA WAY CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-225-1000 MAIL ADDRESS: STREET 1: 1 DNA WAY STREET 2: . CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 dna-8k_q104.htm GENENTECH, INC. - FORM 8-K (APRIL 7, 2004) Genentech, Inc. - Form 8-K (Period ended April 7, 2004)

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 7, 2004

 

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

 

Delaware
(State or other jurisdiction
of incorporation)

1-9813
(Commission
File Number)

94-2347624
(I.R.S. Employer
Identification No.)

 

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

Registrant's telephone number, including area code: (650) 225-1000

 


 

ITEM 5.

OTHER EVENTS

On April 7, 2004, Genentech, Inc., a Delaware corporation, issued a press release announcing earnings for the quarter ended March 31, 2004. A copy of the earnings press release is filed as Exhibit 99.1 to this report.

The non-GAAP financial measures used within our earnings press release include net income and earnings per share (or EPS) for the three months ended March 31, 2004 and 2003 and EPS for the three months ended December 31, 2003. These non-GAAP financial measures exclude recurring charges related to the redemption of our callable putable common stock on June 30, 1999 (the "Redemption") and the effects of push-down accounting, litigation-related special items, and their related tax effects.

Each non-GAAP financial measure presented in the earnings press release is included because our management uses this information to monitor and evaluate Genentech's operating results and trends on an on-going basis. Our management believes the non-GAAP information is also useful for investors because the amounts relating to the Redemption and push-down accounting and the litigation-related special items that are excluded were the result of transactions that are unusual due to their nature, size or infrequency. Consequently, excluding those items from our operating results provides users of the financial statements an important insight into our operating results and related trends that affect our business. In addition, our management uses non-GAAP financial information and measures internally for operating, budgeting and financial planning purposes.

 

ITEM 7.

FINANCIAL STATEMENTS AND EXHIBITS

      (c)  Exhibits.

                99.1  Earnings Press Release of Genentech, Inc. dated April 7, 2004.

 

Page 2


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


     

GENENTECH, INC.

 

Date:

  April 7, 2004

 

/s/ARTHUR D. LEVINSON

     

Arthur D. Levinson, Ph.D.
President and Chief Executive Officer

       
       

Date:

  April 7, 2004

 

/s/LOUIS J. LAVIGNE, JR.

     

Louis J. Lavigne, Jr.
Executive Vice President and
Chief Financial Officer

       
       

Date:

  April 7, 2004

 

/s/JOHN M. WHITING

     

John M. Whiting
Vice President, Controller and
Chief Accounting Officer

 

Page 3


 

EXHIBIT INDEX

Exhibit No.

Description

   

99.1

 

Earnings Press Release of Genentech, Inc. dated April 7, 2004.

 

Page 4


 

EX-99.1 3 dna-8kex99_1.htm GENENTECH, INC. - EARNINGS PRESS RELEASE, APRIL 7, 2004 Genentech Inc. - Exhibit 99.1

 

EXHIBIT 99.1

Genentech

NEWS RELEASE

       
 

Media Contact:

Debra Charlesworth
Caroline Pecquet

(650) 225-2742
(650) 467-7078

 

Investor Contact:

Kathee Littrell

(650) 225-1034

 

http://www.gene.com

 

GENENTECH ANNOUNCES FIRST QUARTER 2004 RESULTS --
INCREASE OF 28 PERCENT IN PRODUCT SALES

SOUTH SAN FRANCISCO, Calif. -- April 7, 2004 -- Genentech, Inc. (NYSE: DNA) today announced total product sales of $763.7 million for the first quarter of 2004, a 28 percent increase over product sales in the first quarter of 2003. Sales for Avastin™ (bevacizumab) were $38.1 million in the first quarter of 2004. Avastin, the first U.S. Food and Drug Administration (FDA) approved therapy designed to inhibit angiogenesis, received FDA approval on February 26, 2004 and Genentech shipped product the same day. Operating revenues increased by 30 percent from the first quarter of 2003 to $975.1 million.

            "Genentech is starting out the year with good quarterly performance, led by strong product sales. We have created a solid foundation for growth in the immediate future and into the next decade, which is key to our Horizon 2010 strategic plan," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer.

            "We are on track with our strategy of investing in new product launches while strengthening our pipeline through increased R&D investments, thereby continuing to create improved shareholder value," said Louis J. Lavigne, Jr., Genentech's executive vice president and chief financial officer. "The first quarter 2004 non-GAAP EPS of $0.38 represents an increase of 41 percent from our fourth quarter 2003 non-GAAP EPS of $0.27. With three products in launch mode coupled with an increase in our tax rate, the nine percent increase in non-GAAP EPS for the first quarter of 2004 compared to the first quarter of 2003 is consistent with our expectations."

Note: First quarter GAAP EPS of $0.33 represents an increase of 38 percent from fourth quarter GAAP 2003 EPS of $0.24. Genentech's non-GAAP earnings per share and non-GAAP net income exclude recurring charges related to the 1999 Roche redemption of Genentech's stock, and litigation-related special items. The differences in non-GAAP and GAAP numbers are reconciled in the tables below.

 

- 1 -


 

For the three months ended March 31, 2004:

  • Operating revenues increased 30 percent to $975.1 million from $749.7 million in the first quarter of 2003. This revenue growth was driven primarily by sales of Genentech's BioOncology products Rituxan® (Rituximab), Herceptin® (Trastuzumab) and Avastin. Total product sales increased 28 percent to $763.7 million from $598.5 million in the first quarter of 2003.
  • Non-GAAP net income increased 14 percent to $207.6 million from $182.6 million in the first quarter of 2003. GAAP net income increased 17 percent to $176.6 million from $151.5 million in the first quarter of 2003.
  • Non-GAAP earnings per share increased 9 percent to $0.38 per share from $0.35 per share in the first quarter of 2003. GAAP earnings per share increased 14 percent to $0.33 per share from $0.29 per share in the first quarter of 2003.

Product Sales

            "We have successfully launched three products in just nine months, while continuing the growth of our sales of existing products like Rituxan and Herceptin. We are particularly proud of launching Avastin within hours of FDA approval on a Thursday so that physicians were able to use Avastin to treat patients for colorectal cancer the following Monday," said Myrtle Potter, president of Commercial Operations. "Sales of Rituxan remain strong, although we did observe impacts from lower inventory levels at distributors, as well as from initial caution among some physicians due to their adjustments to the new reimbursement methodology under the Medicare regulations."

            "With the strong performance of Avastin, we now feel that for 2004 a non-GAAP earnings per share increase in the range of 20 to 25 percent year-over-year is possible. Were revenues to increase further we would consider additional investment in the R&D and Commercial areas," said Lavigne.

 

- 2 -


 

For the three months ended March 31, 2004:

  • Sales of marketed products increased 28 percent to $763.7 million from $598.5 million in the first quarter of 2003.
    • BioOncology sales were 72 percent of total product revenues compared to 73 percent of total product revenues in the first quarter of 2003.
  • Rituxan sales increased 17 percent to $400.6 million from $341.0 million in the first quarter of 2003.
    • Net U.S. sales were $361.8 million, a 17 percent increase from the first quarter of 2003.
    • Non-U.S. sales were $38.8 million compared to $31.0 million in the first quarter of 2003.
  • Herceptin sales increased 21 percent to $113.5 million from $93.7 million in the first quarter of 2003.
  • Avastin, launched in late February, realized sales of $38.1 million for the quarter.
  • Xolair® (Omalizumab) sales were $30.0 million for the quarter.
  • RAPTIVA™ (efalizumab) sales were $6.3 million for the quarter.
  • In legacy products, growth hormone sales increased 11 percent to $85.5 million from $76.7 million in the first quarter of 2003; cardiovascular product sales decreased 3 percent to $46.3 million from $47.5 million in the first quarter of 2003; and Pulmozyme® (dornase alfa, recombinant) Inhalation Solution sales increased 10 percent to $43.4 million from $39.6 million in the first quarter of 2003.

Royalties

            Royalties grew to $154.1 million compared to $113.3 million in first quarter of 2003. The increase is primarily due to higher sales by various licensees.

 

- 3 -


 

Contract Revenues

            Contract revenues increased to $57.3 million compared to $37.9 million in the first quarter of 2003. The increase is primarily due to higher revenues from product opt-ins and reimbursement on development efforts from ongoing collaborations.

Total Costs and Expenses

            Costs and expenses increased as anticipated in the first quarter of 2004 in comparison to costs and expenses in the first quarter of 2003.

  • Research and development (R&D) expenses were $190.3 million compared to $157.4 million in the first quarter of 2003. R&D expenses as a percentage of operating revenues were 20 percent compared to 21 percent in the first quarter of 2003.
  • Cost of sales slightly decreased to $114.5 million from $114.8 million in the first quarter of 2003, primarily due to the product mix reflecting higher sales of more favorable margin products and lower royalty expenses. Cost of sales as a percentage of product sales was 15 percent compared to 19 percent in the first quarter of 2003.
  • Marketing, general and administrative (MG&A) expenses increased to $247.3 million compared to $137.2 million in the first quarter of 2003 due to ongoing expenses for commercial products, primarily Xolair and RAPTIVA, the launch of Avastin, increased promotional programs, higher corporate functional and other expenses, and higher royalty expenses. MG&A expenses as a percentage of operating revenues increased to 25 percent compared to 18 percent in the first quarter of 2003.
  • Collaboration profit-sharing expenses in 2003 increased to $126.4 million compared to $96.6 million in the first quarter of 2003. The growth was attributed to higher Rituxan and Xolair sales.

Webcast:

Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Wednesday, April 7, 2004, at 2:15 p.m. Pacific Time (PT). The live webcast may be accessed on Genentech's website at http://www.gene.com. This webcast will also be available after the call via the website until 5:00 p.m. PT on April 21, 2004. An audio replay of the webcast will be available beginning at 5:15 p.m. PT on April 7, 2004 through 5:15 p.m. PT on April 14, 2004. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); Conference ID number is 5846158.

 

- 4 -


 

About Genentech:

Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 13 biotechnology products in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

 

Genentech Business and Product Development
Events in the First Quarter 2004

Marketed and Pipeline Product Events

Oncology

Avastin:  On February 26, 2004, Genentech announced that the FDA approved Avastin to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line or previously untreated metastatic cancer of the colon or rectum. Avastin is the first FDA-approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis.

Hedgehog Inhibitor:  In collaboration with Curis, Genentech added to its product pipeline a new small molecule, an inhibitor of the Hedgehog signaling pathway, which is under development for basal cell carcinoma.

Immunological Disease

RAPTIVA:  In March, Genentech and XOMA Ltd. announced preliminary results of a randomized, placebo-controlled Phase II study with RAPTIVA in 107 patients with psoriatic arthritis. Results showed a primary endpoint of ACR20 at 12 weeks (84 days) of 28 percent versus19 percent for RAPTIVA versus placebo, which did not reach statistical significance.

 

- 5 -


 

Corporate Events

Genentech provided an overview of its long-range strategy to create sustainable, long-term growth in stockholder value at its annual investment community meeting in New York on March 12, 2004. The strategy, called Horizon 2010, builds upon the company's existing 5x5 plan and sets goals to guide Genentech's vision to become a leader in revolutionizing the treatment of patients with cancer, immunological diseases and angiogenic disorders.

Genentech, Novartis Pharma AG and Tanox, Inc. announced that they settled all litigation among them and finalized the detailed terms of their three-party collaboration, begun in 1996, to develop and commercialize certain anti-IgE antibodies, including Xolair and TNX-901.

Genentech announced that the U.S. Court of Appeals for the Federal Circuit unanimously affirmed the 2002 judgment of a U.S. District Court that found in favor of Genentech that all claims of Chiron Corporation's U.S. Patent No. 6,054,561 asserted against Genentech are invalid.

Construction has begun on a site expansion at Genentech's existing Vacaville biotechnology manufacturing facility. The approximately $600 million investment will help the company meet its long-term production capacity needs. Combined with the current 427,000 square foot facility, the Vacaville site will be the largest biotechnology manufacturing facility in the world.

Genentech announced its board of directors conditionally approved a two-for-one split of the company's common stock in the form of a stock dividend. This stock split will be effected only if stockholders approve an increase in Genentech's authorized common stock at the Annual Meeting of Stockholders, to be held on April 16, 2004. The record and distribution dates will be determined by the Board after the stockholder's meeting if the increase in Genentech's authorized common stock is approved.

 

- 6 -


 

In March, Genentech promoted Susan D. Hellmann, M.D., M.P.H., to president of Product Development, and Myrtle Potter to president of Commercial Operations. Also, David Ebersman, senior vice president of Product Operations, was named to Genentech's Executive Committee; Hal Barron was named chief medical officer, in addition to his role as senior vice president of Development; and Joseph McCracken, vice president of Business Development, was given the additional responsibilities for a newly created function, Strategic Pipeline Development. Todd Pierce was promoted to vice president, Corporate Information Technology, and will chair the company's Information Technology Strategy Council.

Safe Harbor Statement:

The statements made in this press release relating to Genentech's short-term and long-term growth, including EPS growth, are forward-looking and actual results could differ materially. Among other things, Genentech's future growth could be impacted by a number of factors, including FDA actions or delays or failure to receive FDA approval, competition, pricing, reimbursement rates, the ability to supply product, product withdrawals, new product approvals and launches, achieving sales revenue consistent with internal forecasts, unanticipated expenses such as litigation or legal settlement expenses or equity securities writedowns, costs of sales, R&D expenses, fluctuations in contract revenues and royalties, and fluctuations in tax and interest rates. Genentech has no intention, and disclaims any obligation and does not undertake to update or revise the forward-looking statements discussed above in this press release.

# # #

 

- 7 -


 

GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share amounts)
(unaudited)

 
   

Three Months
Ended March 31,

   

2004

 

2003

   

GAAP(1)

 

Differences

 

Non-GAAP(2)

 

GAAP(1)

 

Differences

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

763,700 

       

$

763,700 

 

$

598,482 

       

$

598,482 

   Royalties

 

154,097 

         

154,097 

   

113,275 

         

113,275 

   Contract revenue

 

57,338 

         

57,338 

   

37,915 

         

37,915 

      Total operating revenues

 

975,135 

         

975,135 

   

749,672 

         

749,672 

                                   

Costs and expenses:

                                 

   Cost of sales

 

114,480 

         

114,480 

   

114,842 

         

114,842 

   Research and development

 

190,345 

         

190,345 

   

157,433 

         

157,433 

   Marketing, general and administrative

 

247,314 

         

247,314 

   

137,222 

         

137,222 

   Collaboration profit sharing

 

126,431 

         

126,431 

   

96,547 

         

96,547 

   Recurring charges related to redemption

 

38,209 

 

$

(38,209)

(3)

 

   

38,586 

 

$

(38,586)

(3)

 

   Special charges:  litigation-related

 

13,399 

   

(13,399)

(4)

 

   

13,245 

   

(13,245)

(4)

 

      Total costs and expenses

 

730,178 

   

(51,608)

   

678,570 

   

557,875 

   

(51,831)

   

506,044 

                                     

Operating margin

 

244,957 

   

51,608 

   

296,565 

   

191,797 

   

51,831 

   

243,628 

                                     

Other income, net(5)

 

22,321 

         

22,321 

   

15,703 

         

15,703 

                                     

Income before taxes

 

267,278 

   

51,608 

   

318,886 

   

207,500 

   

51,831 

   

259,331 

Income tax provision

 

90,691 

   

20,644 

   

111,335 

   

56,029 

   

20,733 

   

76,762 

Net income

$

176,587 

 

$

30,964 

 

$

207,551 

 

$

151,471 

 

$

31,098 

 

$

182,569 

                                     

Earnings per share:

                                 
 

Basic

$

0.33 

 

$

0.06 

 

$

0.39 

 

$

0.30 

 

$

0.06 

 

$

0.36 

 

Diluted

$

0.33 

 

$

0.05 

 

$

0.38 

 

$

0.29 

 

$

0.06 

 

$

0.35 

                                     

Weighted average shares used to compute
   earnings per share:

                                 

Basic

 

527,599 

         

527,599 

   

511,909 

         

511,909 

Diluted

 

540,814 

         

540,814 

   

517,266 

         

517,266 

___________________

(1)

 

Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP).

(2)

 

Non-GAAP amounts exclude litigation-related special charges and recurring charges related to the 1999 redemption of Genentech's Special Common Stock, net of related taxes.

(3)

 

Represents the amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(4)

 

Represents accrued interest and bond costs related to the City of Hope trial judgment.

(5)

 

"Other income, net" includes realized gains from the sale of certain biotechnology equity securities and write-downs for other-than-temporary declines in the fair value of certain biotechnology debt and equity securities. In addition, "other income, net" includes interest income and interest expense. For further detail, refer to our web site at www.gene.com.

   

 

   

Q4 2003 Reconciliation of GAAP and Non-GAAP EPS

   

Fourth quarter 2003 GAAP EPS was $0.24 and non-GAAP EPS was $0.27 resulting in a difference of $0.03. Fourth quarter 2003 non-GAAP EPS excludes $38.6 million of recurring charges related to the 1999 Roche redemption of Genentech's stock, and $8.1 million of income on litigation-related special items, net of related taxes of $12.2 million.

 

- 8 -


 

 

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

     
     
 

March 31,

 

 

2004

 

2003(7)

 

Selected balance sheet data:

           

Cash and short-term investments

$

1,637,821 

 

$

1,085,431 

 

Accounts receivable - product sales, net

 

379,492 

   

234,255 

 

Accounts receivable - royalties, net

 

174,497 

   

132,775 

 

Accounts receivable - other, net

 

56,815 

   

23,105 

 

Inventories

 

524,729 

   

411,107 

 

Long-term marketable debt and equity securities

 

1,654,985 

   

567,668 

 

Property, plant and equipment, net

 

1,679,549 

(5)

 

1,114,618 

 

Goodwill

 

1,315,019 

   

1,315,019 

 

Other intangible assets

 

765,415 

   

886,725 

 

Other long-term assets

 

769,221 

(4)

 

800,895 

(4)

Total assets

 

9,134,455 

   

6,808,887 

 

Total current liabilities

 

687,608 

   

643,993 

 

Total liabilities

 

2,027,205 

(6)

 

1,414,924 

 

Total stockholders' equity

 

7,107,250 

   

5,393,963 

 
             

Year-to-date:

           

Capital expenditures

$

97,707 

 

$

73,460 

 
             
             

Total GAAP(1) depreciation and amortization expense

 

78,975 

   

73,016 

 

   Less:  redemption related amortization expense(3)

 

(38,209)

   

(38,586)

 

Non-GAAP(2) depreciation and amortization expense

$

40,766 

 

$

34,430 

 

___________________

(1)

 

In accordance with U.S. generally accepted accounting principles (or GAAP).

(2)

 

Non-GAAP amounts exclude amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(3)

 

Represents the amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(4)

 

Includes $630 million of restricted cash pledged to secure a bond for the City of Hope trial judgment.

(5)

 

Includes $344 million of assets related to the consolidation of a variable interest entity pursuant to Financial Accounting Standards Board Interpretation No. 46 (or FIN 46) on July 1, 2003.

(6)

 

Includes $412 million of debt related to the consolidation of a variable interest entity pursuant to FIN 46.

(7)

 

Certain reclassifications of prior period amounts have been made to conform with the current year presentation.

 

- 9 -


 

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