Tuesday, Jul 15, 1997
Genentech Reports 1997 Second Quarter Results
Earnings Increase 10 Percent on Slight Revenues Decrease
South San Francisco, Calif. -- July 15, 1997 -- Genentech, Inc. (NYSE: GNE) announced today that earnings for the second quarter of 1997 increased 10 percent to $23.8 million, or 19 cents per share, compared to $21.7 million, or 18 cents per share, in the second quarter of 1996. This earnings increase stems primarily from a decrease in Genentech's income tax provision compared to the second quarter of 1996. Revenues decreased slightly to $233.5 million, from $243.8 million in the same quarter of 1996. This decrease results primarily from expected fluctuations in contract and other revenues.
"Our results today importantly reflect our continued efforts at increasing efficiency," said Arthur D. Levinson, Ph.D., Genentech's president and chief executive officer, "as we pursue our long-term strategy and prepare for significant growth into the next century, and as the products in our pipeline progress through clinical trials. Toward our goals, we made significant operational progress in the second quarter. We continued to defend our current markets, and we made key progress with our pipeline projects."
In addition, in the second quarter of 1997, Genentech and Roche agreed to changes to their 1995 ex-U.S. license agreement. "These changes," said Levinson, "will more adequately reflect, for both companies, the practical realities, risks and benefits of working together toward the global development of important medicines."
In the second quarter of 1997, Genentech's income tax provision was $9.3 million (28 percent effective rate) compared to $20.0 million (48 percent effective rate) in the second quarter of 1996. This decrease reflects a tax rate of 28 percent in the second quarter of 1997. The second quarter 1996 tax provision included a "catch-up" for the year-to-date period to an overall 33 percent tax rate.
Marketed Products
Product sales in the second quarter of 1997 were $145.0 million compared to $148.3 million in the second quarter of 1996.
Sales of Activase® (Alteplase, recombinant) were $68.3 million compared to $72.3 million in the second quarter of 1996. During the quarter, Activase's market share as a thrombolytic therapy for the treatment of acute myocardial infarction (heart attack) declined to approximately 79 percent, compared to approximately 80 percent in the second quarter of 1996, and compared to approximately 85 percent in the first quarter of 1997. These results stem from the entry of a new competitive thrombolytic agent and a decline in the overall size of the thrombolytic therapy market as some heart attack patients receive mechanical reperfusion rather than thrombolytic therapy. The results also reflect a gradual increase in sales of Activase for its acute ischemic stroke indication.
Sales of Genentech's three growth hormone products, Protropin® (somatrem for injection), Nutropin® (somatropin [rDNA origin] for injection) and Nutropin AQ (somatropin [rDNA origin] injection) increased slightly to $55.6 million from $54.1 million in the second quarter of 1996. Genentech now has four competitors in the U.S. growth hormone market. Though some market share loss is expected, Genentech has a comprehensive plan to defend its market position.
Pulmozyme® (dornase alfa, recombinant) Inhalation Solution sales were $20.2 million compared to $20.8 million in the second quarter of 1996. During the quarter, Genentech began a Phase III clinical trial to determine whether early intervention with Pulmozyme can benefit young patients with preserved lung function by maintaining their lung function. Pulmozyme is currently cleared for marketing for the management of patients with moderate or advanced cystic fibrosis.
Contract and Other Revenues
Contract and other revenues in the second quarter of 1997 were $16.7 million compared to $27.0 million in the second quarter of 1996. The decrease from the same quarter in the prior year was due to the absence in the current quarter of Roche opt-in revenue, partly offset by an increase in Roche ongoing development cost reimbursements of approximately $7.0 million for insulin-like growth factor (IGF-I) for diabetes outside of the U.S., nerve growth factor (NGF) and rituximab (the C2B8 antibody). Contract and other revenues in the second quarter of 1996 included $19.3 million from Roche, primarily for the exercise of its option to develop IGF-I.
Research and Development
R&D expenses in the second quarter of 1997 were $110.9 million compared to $112.6 million in the second quarter of 1996. For the second quarter of 1997, Genentech invested 47 percent of revenues into R&D.
Besides beginning the Early Intervention Trial for Pulmozyme, Genentech achieved these product development milestones during the quarter:·
- Launched new BioOncology initiative at the American Society of Clinical
Oncology meeting in Denver. In addition to the marketed product Roferon®-A
(Interferon alfa-2a, recombinant), which Genentech began promoting in
the U.S. for its approved oncology indications following a January 1997
agreement with Roche, the initiative also includes the oncology products
that Genentech has under clinical development. These include rituximab
(the C2B8 antibody) under regulatory review for the treatment of relapsed
or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma
and the anti-HER2 antibody, in Phase III clinical trials for the treatment
of metastatic breast cancer.
- Began treating patients with Genentech's NGF in a Phase III clinical
trial in diabetic peripheral neuropathy.
- Presented results of Phase II clinical trials of IGF-I for the treatment
of Type I and Type II diabetes at the June 1997 meeting of the American
Diabetes Association. Genentech is conducting Phase III clinical trials
in Type I diabetes and planning for Phase III clinical trials in Type
II diabetes based on these results.
- With partner Boehringer Ingelheim International Gmbh, began planning
a Phase III clinical trial for TNK t-PA (Genentech's second-generation
t-PA) in the treatment of acute myocardial infarction, based on two
Phase II clinical trials, the results of which will be presented in
August at the European Society of Cardiology meeting in Stockholm.
- Completedone and began a second of two planned Phase I safety trials
of vascular endothelial growth factor (VEGF) in patients with coronary
artery disease.
- Began treating cancer patients in a Phase I safety trial of Genentech's anti-VEGF antibody.
Roche Ex-U.S. License Agreement Revisions
In the second quarter of 1997, Genentech and Roche agreed to changes to their 1995 ex-U.S. license agreement.
"These changes are designed to fine-tune our license agreement to the benefit of both our companies, based on two years of mutual experience in putting the agreement into practice," said Levinson. "The changes reflect the reality of our global collaborative development efforts, and are designed to prevent duplication of effort and expenses. In the spirit of the original agreement, the changes are also designed to more easily align the shared costs and rights with the risks undertaken by each company."
According to the 1995 agreement with Roche, Roche could choose to opt-in for ex-U.S. development of a Genentech product at the end of Phase II, or earlier if Genentech agreed. If Roche chose to opt-in for a product, it would reimburse Genentech for 50 percent of development costs to that date, share ongoing U.S. development costs 50/50, and pay 100 percent of ex-U.S. development costs.
Key changes to Genentech and Roche's 1995 ex-U.S. license agreement are summarized below:
- For future products, Roche may choose to opt-in either when Genentech
determines to move a product into development or at the end of Phase
II (as in the 1995 agreement). U.S. and European development costs will
be shared (discontinuing the distinction regarding location or purpose
of studies).
- If Roche exercises its option at the development determination
point, U.S. and European development costs will be shared 50/50.
- If Roche exercises its option at end of Phase II, Roche will reimburse
Genentech for 50 percent of any development costs incurred, and
subsequent U.S. and European development costs will be shared 75/25,
Roche/Genentech.
- If Roche exercises its option at the development determination
point, U.S. and European development costs will be shared 50/50.
- For IGF-I in diabetes and for NGF, both of which Roche has already
exercised its option to develop, prospective U.S. and European development
costs will be shared 60/40, Roche/Genentech.
- Roche will assume development of the oral IIb/IIIa antagonist globally
on its own. Genentech will provide clinical and scientific input for
the program and may subsequently opt-in and join development at any
time up to the New Drug Application (NDA) filing for the first indication.
- If Genentech chooses to opt-in, Genentech will reimburse Roche
for 50 percent of the U.S. and European development costs incurred
to that date. Roche and Genentech will co-promote the product in
the U.S. with a 60/40, Genentech/Roche profit-sharing if the NDA
filing for the first indication is for acute therapy or a 50/50
profit-sharing if the NDA filing for the first indication is for
chronic therapy.
- If Genentech does not opt-in, Genentech will receive a 6.0 percent royalty on worldwide sales of the oral IIb/IIIa antagonist from Roche.
- If Genentech chooses to opt-in, Genentech will reimburse Roche
for 50 percent of the U.S. and European development costs incurred
to that date. Roche and Genentech will co-promote the product in
the U.S. with a 60/40, Genentech/Roche profit-sharing if the NDA
filing for the first indication is for acute therapy or a 50/50
profit-sharing if the NDA filing for the first indication is for
chronic therapy.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science, six of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
# # #
GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
| Three Months Ended June 30, |
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|---|---|---|---|---|
|
|
||||
| 1997 | 1996 | |||
| Revenues | ||||
| Product sales | $ | 145,018 | $ | 148,305 |
| Royalties | 55,379 | 53,224 | ||
| Contract and other | 16,659 | 27,032 | ||
| Interest | 16,437 | 15,201 | ||
| Total revenues | 233,493 | 243,762 | ||
| Costs and expenses | ||||
| Cost of sales | 25,567 | 27,153 | ||
| Research and development | 110,890 | 112,603 | ||
| Marketing, general and administrative | 63,073 | 60,987 | ||
| Interest | 916 | 1,333 | ||
| Total costs and expenses | 200,446 | 202,076 | ||
| Income before taxes | 33,047 | 41,686 | ||
| Income tax provision | 9,253 | 19,967 | ||
| Net income | $ | 23,794 | $ | 21,719 |
| Net income per share | $ | 0.19 | $ | 0.18 |
| Weighted average number of shares used in computing per share amounts: |
126,539 | 123,257 | ||
| Six Months Ended June 30, |
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|
|
||||
| 1997 | 1996 | |||
| Revenues | ||||
| Product sales | $ | 299,231 | $ | 300,642 |
| Royalties | 120,691 | 106,117 | ||
| Contract and other | 38,068 | 49,132 | ||
| Interest | 32,788 | 30,755 | ||
| Total revenues | 490,778 | 486,646 | ||
| Costs and expenses | ||||
| Cost of sales | 53,252 | 53,032 | ||
| Research and development | 233,633 | 228,236 | ||
| Marketing, general and administrative | 125,054 | 113,029 | ||
| Interest | 1,904 | 2,892 | ||
| Total costs and expenses | 413,843 | 397,189 | ||
| Income before taxes | 76,935 | 89,457 | ||
| Income tax provision | 21,542 | 29,521 | ||
| Net income | $ | 55,393 | $ | 59,936 |
| Net income per share | $ | 0.44 | $ | 0.49 |
| Weighted average number of shares used in computing per share amounts: |
126,101 | 123,309 | ||
| June 30, | ||||
| 1997 | 1996 | |||
| Selected balance sheet data | ||||
| Cash and short-term investments | $ | 684,303 | $ | 753,591 |
| Accounts receivable | 209,622 | 189,829 | ||
| Inventories | 99,667 | 85,447 | ||
| Long-term marketable securities | 472,586 | 391,718 | ||
| Property, plant and equipment, net | 633,942 | 534,484 | ||
| Other long-term assets | 183,682 | 109,500 | ||
| Total assets | 2,331,282 | 2,107,294 | ||
| Total current liabilities | 248,952 | 221,697 | ||
| Long-term debt | 150,000 | 150,000 | ||
| Total liabilities | 424,472 | 397,043 | ||
| Total stockholders' equity | 1,906,810 | 1,710,251 | ||
