Wednesday, Oct 11, 2000

Genentech Reports 25 Percent Increase in Product Sales for Third Quarter

19 Percent Increase in Earnings Per Share

South San Francisco, Calif. -- October 11, 2000 --

Genentech, Inc. (NYSE: DNA) today announced a 25 percent increase in product sales driven by Genentech's oncology drugs and a 19 percent increase in earnings per share1 for the third quarter of 2000, exclusive of the ongoing impact of the 1999 redemption of Genentech's Special Common Stock and related accounting treatment2. As a result of the redemption-related charges, the company recorded minimal net income for the third quarter of 2000.

"During the quarter, we continued to deliver strong financial results fueled by the performance of our oncology products, Rituxan and Herceptin," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "This is an exciting time for Genentech as we lay the groundwork for potential growth with 20 projects in our development pipeline."

For the three months ended September 30, 2000:

  • Exclusive of the impact of the redemption, net income increased to $85.0 million, or 31 cents per share, an increase in earnings per share of 19 percent over the third quarter of 1999. Exclusive of the impact of the redemption, net income for the third quarter of 1999 was $66.9 million, or 26 cents per share.

  • Due to charges related to the redemption, the company recorded a third quarter net income of $4.5 million, or a net income per share of 2 cents. The company recorded a net loss of $62.8 million or 25 cents per share for the third quarter of 1999.

  • Revenues increased 29 percent to $445.2 million from $345.3 million in the same quarter of 1999. This revenue growth was driven primarily by sales of Rituxan® (Rituximab) and Herceptin® (Trastuzumab) and gains on the sales of marketable equity securities. Sales of marketed products increased 25 percent in the third quarter of 2000 to $334.2 million from $267.0 million in the third quarter of 1999.

On October 2, Genentech announced that it submitted for review to the U.S. Food and Drug Administration (FDA) a Supplemental Biologic License Application (sBLA) for Alteplase, recombinant (Activase) for use in restoring function to catheters that have become blocked, preventing the withdrawal of blood samples or infusion of vital fluids to medically ill patients. Also during the quarter, Genentech completed enrollment in two pivotal Phase III clinical trials evaluating anti-CD11a (hu1124) in patients with moderate-to-severe psoriasis. Genentech is developing anti-CD11a with XOMA, Ltd.

Product Sales

Sales of Herceptin in the third quarter of 2000 increased 52 percent to $72.6 million compared to $47.9 million in the third quarter of 1999. Since launch, an increase in penetration into the breast cancer market has contributed to a positive sales trend. During the quarter, Genentech's ex-U.S. marketing partner, Roche, received approval from the European Commission to market Herceptin for the treatment of HER2-positive metastatic breast cancer. In collaboration with Roche, Genentech is conducting trials for the potential adjuvant treatment of early stage breast cancer in patients who overexpress the HER2 protein.

Sales of Rituxan in the third quarter of 2000 increased 62 percent to $117.9 million from $72.6 million in the third quarter of 1999. This sales increase is due primarily to increased market penetration for the treatment of non-Hodgkin's lymphoma. Genentech and IDEC Pharmaceuticals Corporation continue to explore the use of Rituxan as a potential treatment for intermediate and high-grade non-Hodgkin's lymphoma.

During the third quarter of 2000, sales of Genentech's two cardiovascular products, Activase® (Alteplase, recombinant) and TNKaseTM (Tenecteplase), were $50.7 million compared to $59.2 million of Activase sales in the third quarter of 1999. This sales decrease is due to increased competition and to an overall decline in the size of the thrombolytic market due to the increasing use of mechanical reperfusion as well as early intervention with other therapies in the treatment of acute myocardial infarction (AMI). In August, one-year follow-up data for TNKase was presented at the European Society of Cardiology meeting demonstrating comparable efficacy to Activase with the added benefit of being the fastest thrombolytic to administer in the treatment of heart attack. In addition, in collaboration with Boehringer Ingelheim GmbH, TNKase continues to be studied in Phase II and Phase III clinical trials in combination with various anti-thrombotic agents in the potential treatment of AMI.

Sales of Genentech's growth hormone products were $61.1 million compared to $59.9 million in the third quarter of 1999.

Sales of Pulmozyme® (dornase alfa) Inhalation Solution were $30.0 million in the third quarter of 2000 compared to $27.0 million in the third quarter of 1999. During the quarter, Genentech completed a Phase III clinical trial of Pulmozyme in early-stage cystic fibrosis. Trial results will be presented in November 2000.

Total Costs and Expenses

Costs and expenses increased in the third quarter of 2000 as compared to the third quarter of 1999.

Primarily due to the increase in product sales, cost of sales, exclusive of expenses related to the redemption and push-down accounting, increased to $75.6 million in the third quarter of 2000 from $46.0 million in the third quarter of 1999. The increase in cost of sales as a percentage of sales is primarily due to product mix as well as an increase in provisions established for nonuseable inventory.

Research and development (R&D) expenses increased in the third quarter of 2000 to $113.6 million compared to $84.6 million in 1999 due primarily to an increase in expenses related to later-stage clinical trials. R&D expenses as a percentage of revenues in the third quarter of 2000 were 26 percent, compared to approximately 25 percent in the third quarter of 1999. R&D expenses as a percent of revenues are expected to continue to vary over the next several periods dependent on possible in-licensing agreements and as products progress through late-stage clinical trials.

Marketing, general and administrative (MG&A) expenses during the third quarter of 2000 were $131.7 million compared to $113.6 million in the third quarter of 1999. The increase is due primarily to the Rituxan profit-sharing expense, as well as increased sales and marketing expenses related to competitive conditions with other marketed products and the Xolairo (Omalizumab) launch preparation.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine 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.

Webcast

Genentech will be offering a live webcast of this conference call. This webcast will also be available after the call via our website until October 18. To access the webcast, please visit our website at www.gene.com and follow the instructions provided.

Replay

An audio replay of the Genentech 3rd Quarter 2000 analyst conference call will be available for a 7-day period commencing 9:30 a.m. (Pacific time), Oct. 11 through 9:30 a.m. (Pacific time), Oct. 18, 2000. Access numbers for this replay are 1-800-633-8284 (domestic) and 858-812-6440 (international); passcode number is 16362099.

Genentech Business and Product Development Events in the Third Quarter, 2000

Genentech announced the following:

  • Submitted for review to the FDA an sBLA for Activase for use in catheter clearance.

  • Completed patient enrollment in two pivotal Phase III clinical trials evaluating anti-CD11a in patients with moderate-to-severe psoriasis. Genentech is developing anti-CD11a with XOMA, Ltd.

  • Genentech's European partner, Roche, received European Union approval for Herceptin.

  • IDEC, Genentech's partner on Rituxan, received a "completion of review" letter from the FDA regarding the Supplemental Biologic License Application (sBLA) for Rituxan to include: retreatment with Rituxan; extended initial therapy (eight weekly infusion instead of four); and treatment of patients with bulky disease.

  • Completed a Phase III clinical trial of Pulmozyme in early-stage cystic fibrosis. Trial results will be presented in November 2000.

  • Signed agreement with UroGenesys, which provides Genentech with exclusive worldwide license to develop antibody-based therapeutics for cancer using Prostate Stem Cell Antigen (PSCA) as a target antigen.

  • Announced the appointment of Joseph McCracken to vice president, Business Development.

  • Announced the promotion of David Nagler to vice president, Human Resources.

  • In May, announced the promotion of Roy C. Hardiman to vice president, Corporate Law.

  • In May, announced the promotion of Andrew Scherer to vice president, Engineering and Facilities.

  • In October, announced a 2-for-1 stock split to be effective in the form of a stock dividend. The record date of this transaction is October 17 with distribution beginning October 24.

1 All earnings (loss) per share data and number of shares reflect the stock split effective November 2, 1999.

2 The accounting treatment under U.S. Generally Accepted Accounting Principles (GAAP) requires Genentech to establish a new accounting basis for the company's assets and liabilities. This accounting treatment is the result of Roche's exercise of its option to redeem Genentech's Special Common Stock in June 1999. The company's new accounting basis is based on the cost of Roche's 1990 through 1997 purchases of Genentech shares and the redemption of Genentech's Special Common Stock on June 30, 1999. Roche's cost of acquiring Genentech is "pushed down" to Genentech and reflected on Genentech's financial statements beginning June 30, 1999. The effect of push-down accounting on Genentech's first, second and third quarter 2000 consolidated statements of operations include recurring charges for the amortization of goodwill and other intangibles, and costs related to the sale of inventory that was written up at the redemption.

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

Three Months
Ended September 30,

2000 1999

Actual Pro Forma(1) Actual Pro Forma(1)
Revenues
   Product sales $ 334,173 $ 334,173 $ 266,968 $ 266,968
   Royalties 51,818 51,818 46,128 46,128
   Contract and other 33,479 33,479 7,503 7,503
   Interest 25,712 25,712 24,729 24,729
      Total revenues 445,182 445,182 345,328 345,328
     
Costs and expenses
   Cost of sales 91,356 75,584 92,750 45,936
   Research and development 113,636 113,636 84,629 84,629
   Marketing, general and administrative 131,726 131,726 113,613 113,613
   Special charge:        
      Related to redemption - - 57,800 -
   Recurring charges related to redemption 97,780 - 98,986 -
   Interest 1,175 1,175 1,326 1,326
      Total costs and expenses 435,673 322,121 449,104 245,504
     
Income (loss) before taxes 9,509 123,061 (103,776) 99,824
Income tax (benefit) provision 5,044 38,149 (40,931) 32,942
     
Net income (loss) $ 4,465 $ 84,912 $ (62,845) $ 66,882
     
Earnings (loss) per share:        
   Basic $ 0.01 $ 0.16 $ (0.12) $ 0.13
   Diluted $ 0.01 $ 0.16 $ (0.12) $ 0.13
     
Weighted average shares used to
   compute earnings (loss) per share:
       
   Basic 522,928 522,928 511,413 511,413
   Diluted 541,483 541,483 511,413 524,325

(1) Pro Forma amounts exclude the special charge related to the redemption, recurring charges related to the redemption and costs related to the sale of inventory that was written up at the redemption.


Nine Months
Ended September 30,

2000 1999

Actual Pro Forma(1) Actual Pro Forma(1)
Revenues
   Product sales $ 926,765 $ 926,765 $ 770,392 $ 770,392
   Royalties 148,805 148,805 138,732 138,732
   Contract and other 99,524 99,524 84,684 64,347
   Interest 69,448 69,448 69,114 69,114
      Total revenues 1,244,542 1,244,542 1,062,922 1,042,585
     
Costs and expenses
   Cost of sales 295,148 204,724 191,154 144,340
   Research and development 340,605 340,605 269,580 269,580
   Marketing, general and administrative 350,830 350,830 328,186 328,186
   Special charges:        
      Legal settlement - - 50,000 -
      Related to redemption - - 1,205,104 -
   Recurring charges related to redemption 294,399 - 98,986 -
   Interest 3,701 3,701 4,045 4,045
      Total costs and expenses 1,284,683 899,860 2,147,055 746,151
     
Income (loss) before taxes (40,141) 344,682 (1,084,133) 296,434
Income tax (benefit) provision (4,541) 106,851 (112,511) 97,823
     
Net income (loss) $ (35,600) $ 237,831 $ (971,622) $ 198,611
     
Earnings (loss) per share:        
   Basic $ (0.07) $ 0.46 $ (1.90) $ 0.39
   Diluted $ (0.07) $ 0.44 $ (1.90) $ 0.38
     
Weighted average shares used to
   compute earnings (loss) per share:
       
   Basic 521,097 521,097 512,050 512,050
   Diluted 521,097 540,060 512,050 529,353
 
September 30,
2000 1999
Selected balance sheet data
   Cash and short-term investments $ 996,786 $ 688,886
   Accounts receivable 238,993 185,220
   Inventories 237,834 284,972
   Long-term marketable securities 1,567,247 918,569
   Property, plant and equipment, net 743,378 721,990
   Goodwill 1,512,773 1,667,382
   Other intangible assets 1,321,244 1,506,478
   Other long-term assets 167,366 182,158
   Total assets 6,932,540 6,169,395
   Total current liabilities 410,683 355,446
   Long-term debt 149,692 149,708
   Total liabilities 1,268,902 942,293
   Total stockholders' equity 5,663,638 5,227,102
Year-to-date
   Capital expenditures 78,994 65,347
   Pro forma depreciation and amortization expense 72,866 69,799

(1) Pro Forma amounts exclude special charges related to a legal settlement and the redemption, recurring charges related to the redemption and costs related to the sale of inventory that was written up at the redemption.


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