-----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, IyJLneCZQ0aYnMXKOs/LT36j5YPNi3pYs1v+kbNtmtQWzWREKKKn3rGRcSJL61nX NafNMXtL6LevBxO32xW76A== 0000318771-04-000008.txt : 20040707 0000318771-04-000008.hdr.sgml : 20040707 20040707162236 ACCESSION NUMBER: 0000318771-04-000008 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040707 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040707 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: 04904494 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_q204.htm GENENTECH, INC. - FORM 8-K (JULY 7, 2004) Genentech, Inc. - Form 8-K (Period ended July 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): July 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 July 7, 2004, Genentech, Inc., a Delaware corporation, issued a press release announcing earnings for the quarter ended June 30, 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 and six months ended June 30, 2004 and 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 charges, 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 July 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:

  July 7, 2004

 

/s/ARTHUR D. LEVINSON

     

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

       
       

Date:

  July 7, 2004

 

/s/LOUIS J. LAVIGNE, JR.

     

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

       
       

Date:

  July 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 July 7, 2004.

 

Page 4


 

EX-99.1 2 dna-8kex99_1.htm GENENTECH, INC. - EXNIBIT 99.1 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 SECOND QUARTER 2004 RESULTS

- Product Sales Increase 42 Percent, Drive Record Quarterly Revenues of $1.1 Billion -

SOUTH SAN FRANCISCO, Calif. -- July 7, 2004 -- Genentech, Inc. (NYSE: DNA) today announced total product sales of $913.4 million for the second quarter of 2004, a 42 percent increase over product sales of $644.3 million in the second quarter of 2003. Operating revenues increased by 41 percent from the second quarter of 2003 to $1.1 billion. Avastin™ (bevacizumab), in its first full quarter of sales, realized sales of $133.0 million for the second quarter of 2004.

            "Genentech topped $1 billion in quarterly revenues for the first time in our history, and we are exiting the first half of the year with revenues of more than $2 billion," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Our unrelenting focus on science has led us to launch three successful products, Avastin, Xolair and RAPTIVA, in a recent nine-month period. We remain committed to our 5x5 goals, and our recent product launches direct us toward our Horizon 2010 objectives."

            "The success of new product launches and the continued strength of our existing product sales are driving our operating revenues growth of 41 percent over the same quarter last year," said Myrtle Potter, president of Commercial Operations. "Rituxan continued to exhibit healthy growth, with a 17 percent increase over the same period last year. Also, our new product launches are contributing to ongoing revenue growth. Our three new product launches contributed $190.1 million or 21 percent of total net product sales for the second quarter of 2004. Our teams are also gearing up for the potential upcoming launch of Tarceva."

            "We continue to deliver on our earnings per share targets while making strong investments in our new product launches and research and development initiatives," said Louis J. Lavigne, Jr., Genentech's executive vice president and chief financial officer. "Based on our current view of the business, we have now raised our goal for 2004 non-GAAP EPS to be in the range of $0.75 to $0.80."

 

- 1 -


 

For the three months ended June 30, 2004:

  • Operating revenues increased 41 percent to $1,128.2 million from $799.7 million in the second quarter of 2003. Total product sales increased 42 percent to $913.4 million from $644.3 million in the second quarter of 2003.
     
  • Non-GAAP net income increased 23 percent to $201.8 million from $163.5 million in the second quarter of 2003. GAAP net income increased 29 percent to $170.8 million from $132.3 million in the second quarter of 2003.
     
  • Non-GAAP earnings per share increased 19 percent to $0.19 per share from $0.16 per share in the second quarter of 2003. GAAP earnings per share increased by 23 percent to $0.16 per share from $0.13 per share in the second quarter of 2003.

Note:  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 and on www.gene.com. All share and per share amounts reflect the May 2004 two-for-one split of Genentech common stock.

Along with the discontinuation of Nutropin Depot® (somatropin [RDNA origin] for injectable suspension), Genentech took a charge of $37.4 million, of which $18.6 million was related to the Nutropin Depot license and $18.8 million was related to inventory. In addition, during the quarter, Genentech took a provision of $21.3 million related to filling failures for other products.

Product Sales

For the three months ended June 30, 2004:

  • Sales of marketed products increased 42 percent to $913.4 million from $644.3 million in the second quarter of 2003.
     
    • BioOncology sales were 74 percent of total product revenues compared to 73 percent of total product revenues in the second quarter of 2003.
       
  • Avastin, in its first full quarter of sales, realized sales of $133.0 million for the quarter.
     
  • Rituxan® (Rituximab) sales increased 17 percent to $424.7 million from $363.4 million in the second quarter of 2003.
     
    • Net U.S. sales were $390 million, a 19 percent increase from the second quarter of 2003.
       
    • Ex-U.S. sales were $34.7 million compared to $35.4 million in the second quarter of 2003.
       
  • Herceptin® (Trastuzumab) sales increased 8 percent to $117.7 million from $109.1 million in the second quarter of 2003.
     
  • Xolair® (Omalizumab) sales were $43.7 million for the quarter.

 

 - 2 -


 

  • RAPTIVA® (efalizumab) sales were $13.4 million for the quarter.
     
  • Sales of legacy products, including growth hormone, cardiovascular products and Pulmozyme® (dornase alfa, recombinant) Inhalation Solution, increased 5 percent to $180.9 million from $171.8 million in the second quarter of 2003.

Royalties
            Royalties grew to $151.9 million compared to $122.8 million in the second quarter of 2003. The increase is primarily due to higher royalties from Roche for Rituxan and Herceptin.

Contract Revenues
            Contract revenues increased to $62.9 million compared to $32.6 million in the second quarter of 2003. The increase is primarily due to higher revenues from ongoing collaborations, including ongoing payments after opt-ins from Roche and other parties.

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

  • Research and development (R&D) expenses were $212.9 million compared to $180.2 million in the second quarter of 2003. R&D expenses as a percentage of operating revenues were 19 percent compared to 23 percent in the second quarter of 2003.
     
  • Cost of sales increased to $186.7 million from $123.4 million in the second quarter of 2003, primarily due to the inclusion of an $18.8 million charge related to Nutropin Depot inventory and a provision of $21.3 million related to filling failures for other products. Cost of sales as a percentage of product sales was 20 percent compared to 19 percent in the second quarter of 2003.
     
  • Marketing, general and administrative (MG&A) expenses increased to $276.7 million compared to $184.3 million in the second quarter of 2003 due to ongoing expenses for commercial products, primarily related to the launch of three new products and preparation for the potential launch of Tarceva&trade (erlotinib HCl), and a charge of $18.6 million related to the license for Nutropin Depot. MG&A expenses as a percentage of operating revenues increased to 25 percent compared to 23 percent in the second quarter of 2003.
     
  • Collaboration profit-sharing expenses in the second quarter of 2004 increased to $145.2 million compared to $107.3 million in the second quarter of 2003. The growth in these expenses is attributable to higher Rituxan and Xolair sales.

 

- 3 -


 

Webcast:
Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Wednesday, July 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 July 21, 2004. An audio replay of the webcast will be available beginning at 5:15 p.m. PT on July 7, 2004 through 5:15 p.m. PT on July 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 8133116.

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 12 biotechnology products directly 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 press releases and additional information about the company, please visit http://www.gene.com.

 

Genentech Business and Product Development
Events in the Second Quarter 2004

MARKETED AND PIPELINE PRODUCT EVENTS

Oncology


Medical Meetings:
  Data from more than 150 abstracts were presented on Genentech oncology products at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 5-8.

Avastin:  Genentech and Roche announced that The New England Journal of Medicine published Genentech's Phase III pivotal trial for Avastin in first-line (previously untreated) metastatic colorectal cancer. The study showed that the addition of Avastin to the IFL (5-FU/Leucovorin/CPT-11) chemotherapy regimen significantly extended survival in patients with first-line metastatic colorectal cancer. The median survival of patients treated with Avastin plus the IFL chemotherapy regimen was extended by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone.

Genentech enrolled the first patient in the Avastin Phase III pancreatic cancer study in early June.

Tarceva:  At ASCO, Genentech announced with OSI Pharmaceuticals, Inc. and Roche that a Phase III study of Tarceva in advanced non-small cell lung cancer (NSCLC) demonstrated a 42.5 percent improvement in median survival and a 41 percent improvement in one-year survival rates compared to placebo.

 

- 4 -


 

In late June, OSI Pharmaceuticals announced that the New Drug Application for Tarceva was accepted into the U.S. Food and Drug Administration's Pilot 1 Program for Continuous Marketing Applications. The Pilot 1 Program is designed for products that have been designated Fast Track status and have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for the disease or condition.

On June 16, 2004,Genentech and OSI Pharmaceuticals announced agreements detailing the roles of the two companies with respect to promotion, marketing and manufacturing of Tarceva, if it is approved for distribution in the United States.

After the completion of the first stage of a Phase II study of Tarceva for glioblastoma multiforme (GBM) conducted in collaboration with ABC2, Genentech and OSI Pharmaceuticals decided not to proceed to the second stage based upon a lower-than-expected objective response with single-agent Tarceva in this setting. Research on the potential to use Tarceva in the treatment of GBM will be pursued through ongoing investigator-sponsored trials.

Combination Targeted Therapies:  Genentech and OSI Pharmaceuticals announced at ASCO results from Phase I/II clinical studies examining the combination of Avastin and Tarceva in the treatment of metastatic renal cell carcinoma (kidney cancer) and relapsed non-small cell lung cancer (NSCLC). Other studies of this combination were presented, including metastatic breast cancer and head and neck cancer.

Genentech added to its development pipeline a randomized, multi-center Phase II study of the combination of Avastin and Tarceva in patients with first-line metastatic renal cell carcinoma, based on positive Phase II single-arm trial data.

Rituxan:  Also at ASCO, Genentech, Biogen Idec Inc. and Roche announced positive data from a large, randomized Phase III cooperative group trial (E1496) evaluating Rituxan as maintenance therapy for newly diagnosed patients with indolent non-Hodgkin's lymphoma (NHL) following initial (induction) treatment with chemotherapy. The study authors concluded that there was a significant improvement in progression-free survival (PFS), the primary endpoint of the study. Also presented were data from the MabThera International Trial (MinT) study of R-CHOP (Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) in younger patients with newly diagnosed, aggressive NHL.

Earlier in the quarter, Roche announced the initial results of the European Organization for Research and Treatment of Cancer (EORTC) 20981 trial of Rituxan in patients with relapsed indolent NHL. The trial evaluated patients treated with Rituxan and CHOP or CHOP alone followed by Rituxan maintenance therapy for two years and was stopped early due to efficacy when initial results showed Rituxan to be the best therapeutic option in both arms of the trial.

 

- 5 -


 

Herceptin:  In June, Roche announced that the European Commission approved the use of Herceptin in combination with Taxotere® (docetaxel) in the European Union as a first-line therapy in HER2-positive metastatic breast cancer patients who have not yet received chemotherapy.

As presented at ASCO, a Phase II investigator-sponsored study of Herceptin plus anthracycline chemotherapy versus anthracycline chemotherapy alone in the neoadjuvant setting was stopped early when initial results demonstrated a significant increase in pathological complete response in patients with operable breast cancer. While there were no observed cases of congestive heart failure (CHF) in this small study, there has been an increased incidence of CHF reported with the use of Herceptin in patients previously treated with anthracyclines.

Omnitarg&trade  (pertuzumab):  In the Phase II open-label trial of Omnitarg, evidence was observed of anti-tumor activity, including objective responses and durable stable disease in patients with advanced, relapsed/refractory ovarian cancer. While there was evidence of clinical benefit in the trial, the objective response rate was not adequate for an accelerated approval or pursuit of a Phase III trial for single-agent therapy in ovarian cancer at this time. Moving forward, Omnitarg will be evaluated in combination with chemotherapy in a Phase II trial in ovarian cancer.

Immunology and Specialty Biotherapeutics

Xolair:  Genentech, with Novartis Pharma AG and Tanox, Inc., enrolled the first patient in the Phase II Xolair peanut allergy study of 150 patients, also known as TOPS.

Novartis Pharma AG submitted its application for the European approval of Xolair to the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Medicinal Products for Human Use (CHMP).

Rituxan:  Genentech, Biogen Idec and Roche announced in June that The New England Journal of Medicine published the results of a Phase IIa study showing that two doses of Rituxan, administered two weeks apart, improved symptoms in patients with moderate-to-severe rheumatoid arthritis (RA) for up to 48 weeks when combined with methotrexate (MTX), compared to MTX alone.

In June, Genentech enrolled the first patient in the OLYMPUS study, a Phase II/III study of Rituxan in patients with primary progressive multiple sclerosis (PPMS).

RAPTIVA:  Serono S.A. announced that CHMP made a unanimous recommendation for approval of RAPTIVA in the European Union.

 

- 6 -


 

BR3-Fc:  A new molecular entity for rheumatoid arthritis, a BR3 fusion protein, which resulted from a collaboration with Biogen Idec, has been entered into the development pipeline.

Nutropin Depot:  In June, Genentech and Alkermes Inc. announced their decision to discontinue commercialization of Nutropin Depot. The decision was based on the significant resources required by both companies to continue manufacturing and commercializing the product.

 

CORPORATE EVENTS

The Genentech board of directors approved a two-for-one split of common stock in the form of a stock dividend. The stock split's record date was April 28, 2004, and additional shares were distributed beginning May 12, 2004. Genentech also announced the election of William M. Burns, head of Pharmaceuticals of the Roche Group, and Erich Hunziker, Ph.D., chief financial officer of the Roche Group, to the board of directors. Franz B. Humer, chairman and chief executive officer of the Roche Group, resigned from the board.

The Genentech Foundation for Biomedical Sciences, an independent foundation, awarded 23 grants totaling $1,061,090 to San Francisco Bay Area educational institutions that support biomedical research and education for local students.

Genentech announced the following senior officer promotions and appointments:  Vince Anicetti was promoted to vice president, Product Portfolio Management; Martin Babler was promoted to vice president, Immunology Sales and Marketing; Charlie Johnson was promoted to vice president, Clinical Biotherapeutics; and Karen McCormick was hired as vice president, Specialty Therapeutic Sales & Marketing.

The statements made in this press release relating to the potential launch of Tarceva and 2004 non-GAAP EPS are forward-looking and actual results could differ materially. Among other things, the potential launch of Tarceva could be impacted by a number of factors, including manufacturing issues, discussions with the FDA, the need for additional clinical studies, FDA actions or delays, or the failure to receive FDA approval; and 2004 non-GAAP EPS could be impacted by all of the foregoing and by competition, pricing, new product approvals and launches, government reimbursement rates, the ability to supply product, product withdrawals, 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 disclaims any obligation and does not undertake to upda te or revise the forward-looking statements discussed in this press release.

# # #

 

- 7 -


 

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

 
   

Three Months
Ended June 30,

   

2004

 

2003

   

GAAP(1)

 

Differences

 

Non-GAAP(2)

 

GAAP(1)

 

Differences

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

913,366 

       

$

913,366 

 

$

644,324 

       

$

644,324 

   Royalties

 

151,860 

         

151,860 

   

122,786 

         

122,786 

   Contract revenue

 

62,852 

         

62,852 

   

32,602 

         

32,602 

      Total operating revenues

 

1,128,078 

         

1,128,078 

   

799,712 

         

799,712 

                                   

Costs and expenses:

                                 

   Cost of sales

 

186,683 

         

186,683 

   

123,407 

         

123,407 

   Research and development

 

212,886 

         

212,886 

   

180,203 

         

180,203 

   Marketing, general and administrative

 

276,654 

         

276,654 

   

184,258 

         

184,258 

   Collaboration profit sharing

 

145,221 

         

145,221 

   

107,307 

         

107,307 

   Recurring charges related to redemption

 

38,209 

 

$

(38,209)

(3)

 

   

38,586 

 

$

(38,586)

(3)

 

-  

   Special charges:  litigation-related

 

13,458 

   

(13,458)

(4)

 

   

13,363 

   

(13,363)

(4)

 

-  

      Total costs and expenses

 

873,111 

   

(51,667)

   

821,444 

   

647,124 

   

(51,949)

   

595,175 

                                     

Operating margin

 

254,967 

   

51,667 

   

306,634 

   

152,588 

   

51,949 

   

204,537 

                                     

Other income, net(5)

 

15,444 

   

   

15,444 

   

40,870 

   

   

40,870 

                                     

Income before taxes

 

270,411 

   

51,667 

   

322,078 

   

193,458 

   

51,949 

   

245,407 

Income tax provision

 

99,640 

   

20,666 

   

120,306 

   

61,113 

   

20,779 

   

81,892 

Net income

$

170,771 

 

$

31,001 

 

$

201,772 

 

$

132,345 

 

$

31,170 

 

$

163,515 

                                     

Earnings per share:(6)

                                 
 

Basic

$

0.16 

 

$

0.03 

 

$

0.19 

 

$

0.13 

 

$

0.03 

 

$

0.16 

 

Diluted

$

0.16 

 

$

0.03 

 

$

0.19 

 

$

0.13 

 

$

0.03 

 

$

0.16 

                                     

Weighted average shares used to compute
   earnings per share: (6)

                                 

Basic

 

1,060,619 

         

1,060,619 

   

1,025,818 

         

1,025,818 

Diluted

 

1,087,087 

         

1,087,087 

   

1,045,829 

         

1,045,829 

___________________

(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 and losses 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.

(6)

 

All share and per share amounts reflect the May 2004 two-for-one stock split of our Common Stock.

2004 Reconciliation of GAAP and Non-GAAP EPS
Our 2004 GAAP EPS is not estimable at this time. The 2004 GAAP EPS would include recurring charges related to the 1999 redemption of our stock by Roche, which are estimated to be approximately $145 million on a pretax basis in 2004. In addition, the 2004 GAAP EPS would include litigation-related special charges for accrued interest and associated bond costs on the City of Hope judgment, which are estimated to be approximately $54 million on a pretax basis in 2004. The 2004 non-GAAP EPS estimate does not include the redemption related recurring charges and the litigation-related special charges or any other potential special charges related to existing or future litigation or its resolution, or changes in accounting principles, all of which may be significant.

 

- 8 -


 

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

 
   

Six Months
Ended June 30,

   

2004

 

2003

   

GAAP(1)

 

Differences

 

Non-GAAP(2)

 

GAAP(1)

 

Differences

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

1,677,066 

       

$

1,677,066 

 

$

1,242,806 

       

$

1,242,806 

   Royalties

 

305,957 

         

305,957 

   

236,061 

         

236,061 

   Contract revenue

 

120,190 

         

120,190 

   

70,517 

         

70,517 

      Total operating revenues

 

2,103,213 

         

2,103,213 

   

1,549,384 

         

1,549,384 

                                   

Costs and expenses:

                                 

   Cost of sales

 

301,163 

         

301,163 

   

238,249 

         

238,249 

   Research and development

 

403,231 

         

403,231 

   

337,636 

         

337,636 

   Marketing, general and administrative

 

523,968 

         

523,968 

   

321,480 

         

321,480 

   Collaboration profit sharing

 

271,652 

         

271,652 

   

203,854 

         

203,854 

   Recurring charges related to redemption

 

76,418 

 

$

(76,418)

(3)

 

   

77,172 

 

$

(77,172)

(3)

 

-  

   Special charges:  litigation-related

 

26,857 

   

(26,857)

(4)

 

   

26,608 

   

(26,608)

(4)

 

-  

      Total costs and expenses

 

1,603,289 

   

(103,275)

   

1,500,014 

   

1,204,999 

   

(103,780)

   

1,101,219 

                                     

Operating margin

 

499,924 

   

103,275 

   

603,199 

   

344,385 

   

130,780 

   

448,165 

                                     

Other income, net(5)

 

37,765 

   

-  

   

37,765 

   

56,573 

   

-  

   

56,573 

                                     

Income before taxes

 

537,689 

   

103,275 

   

640,964 

   

400,958 

   

130,780 

   

504,738 

Income tax provision

 

190,331 

   

41,310 

   

231,641 

   

117,143 

   

41,511 

   

158,654 

Net income

$

347,358 

 

$

61,965 

 

$

409,323 

 

$

283,815 

 

$

62,269 

 

$

346,084 

                                     

Earnings per share: (6)

                                 
 

Basic

$

0.33 

 

$

0.06 

 

$

0.39 

 

$

0.28 

 

$

0.06 

 

$

0.34 

 

Diluted

$

0.32 

 

$

0.06 

 

$

0.38 

 

$

0.27 

 

$

0.06 

 

$

0.33 

                                     

Weighted average shares used to compute
   earnings per share: (6)

                                 

Basic

 

1,057,955 

         

1,057,955 

   

1,024,796 

         

1,024,796 

Diluted

 

1,084,618 

         

1,084,618 

   

1,040,204 

         

1,040,204 

___________________

(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 and losses 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.

(6)

 

All share and per share amounts reflect the May 2004 two-for-one stock split of our Common Stock.

 

- 9 -


 

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

     
     
 

June 30,

 

 

2004

 

2003(6)

 

Selected balance sheet data:

           

Cash, cash equivalents and short-term investments

$

1,619,134 

 

$

1,215,813 

 

Accounts receivable - product sales, net

 

464,032 

   

270,993 

 

Accounts receivable - royalties, net

 

189,513 

   

140,693 

 

Accounts receivable - other, net

 

88,901 

   

267,770 

 

Inventories

 

527,649 

   

422,414 

 

Long-term marketable debt and equity securities

 

1,414,663 

   

785,877 

 

Property, plant and equipment, net

 

1,740,423 

(4)

 

1,146,875 

 

Goodwill

 

1,315,019 

   

1,315,019 

 

Other intangible assets

 

710,644 

   

865,719 

 

Other long-term assets

 

817,906 

   

793,345 

 

Total assets

 

9,055,039 

   

7,459,115 

 

Total current liabilities

 

836,876 

   

598,721 

 

Total liabilities

 

2,170,005 

(5)

 

1,606,182 

 

Total stockholders' equity

 

6,885,034 

   

5,852,933 

 
             

Year-to-date:

           

Capital expenditures

$

196,633 

 

$

140,145 

 
             
             

Total GAAP(1) depreciation and amortization expense

 

178,520 

   

144,871 

 

   Less:  redemption related amortization expense(3)

 

(76,418)

   

(77,172)

 

Non-GAAP(2) depreciation and amortization expense

$

102,102 

 

$

67,699 

 

___________________

(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 $338 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.

(5)

 

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

(6)

 

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

 

- 10 -


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