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
February 23, 1996
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Date of Report (Date of earliest event reported)
GENENTECH, INC.
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(Exact name of registrant as specified in it charter)
Delaware 1-9813 94-2347624
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(State or other (Commission (I.R.S. Employer
jurisdiction of File Number) Identification No.)
incorporation)
460 Point San Bruno Boulevard
South San Francisco, California 94080
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(Address or principal executive offices)
(415) 225-1000
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(Registrant's telephone number, including area code)
ITEM 5. OTHER EVENTS.
In connection with the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, Genentech, Inc. (the
"Company") is hereby filing a cautionary statement identifying important
factors that could cause the Company's actual results to differ
materially from those projected in forward looking statements of the
Company made by, or on behalf of, the Company.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
Exhibit:
99.1 Cautionary Statement Identifying Important Factors that
Could Cause the Company's Actual Results to Differ from
Those Projected in Forward Looking Statements.
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.
Registrant
Date: February 23, 1996
By: /S/LOUIS J. LAVIGNE, JR.
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Louis J. Lavigne, Jr.
Senior Vice President and
Chief Financial Officer
Exhibit 99.1
Cautionary Statement Identifying Important Factors that Could Cause the
Company's Actual Results to Differ from those Projected in Forward
Looking Statements
The following factors could affect Genentech's actual future results,
including its product sales, royalties, expenses and net income, and
could cause them to differ from any forward-looking statements made by
or on behalf of the Company:
- Decisions by F. Hoffmann-LaRoche Ltd. ("HLR") as to whether to
exercise its rights to develop and sell products and potential products
of the Company.
- Increased competition in the growth hormone market. Three companies
received FDA approval in 1995 to market their growth hormone products
for treatment of growth hormone inadequacy in children. Two of these
companies are currently temporarily prohibited from entering the U.S.
market pending a full hearing on certain patent claims of Genentech. The
Company expects competition to have an adverse effect on its sales of
Protropin, registered trademark, and Nutropin, registered trademark.
Other factors that may influence sales of these products include the
availability of third party reimbursement for the cost of growth hormone
therapy and the outcome of litigation involving the Company's patents
for growth hormone and related processes, including that referred to
above.
- Acceptance of Pulmozyme, registered trademark, as a treatment for
cystic fibrosis. Factors that may influence the future sales of
Pulmozyme include physician perception of the number and kinds of
patients who will benefit from such therapy, the availability of third
party reimbursement for the costs of therapy, the timing of the
development of alternative therapies for the treatment and care of
cystic fibrosis, whether and when additional indications are approved
for Pulmozyme and the cost of Pulmozyme therapy.
- Variation of royalty, contract and other revenues. These revenues
will continue to fluctuate due to the timing of non-U.S. approvals, if
any, for products licensed to HLR, whether and when contract benchmarks
are achieved, the initiation of new contractual arrangements, including
the exercise of product options by HLR, and the conclusion of existing
arrangements with other companies and HLR.
- Successful development of products. The Company intends to continue
to develop new products. Successful pharmaceutical product development
is highly uncertain and is dependent on numerous factors, many of which
are beyond the Company's control. Products that appear promising in the
early phases of development may fail to reach market for numerous
reasons. They may be found to be ineffective or to have harmful side
effects in clinical or pre-clinical testing, they may fail to receive
necessary regulatory approvals, may turn out to be uneconomic because of
manufacturing costs or other factors, or they may be precluded from
commercialization by the proprietary rights of others. Success in
preclinical and early clinical trials does not insure that large scale
clinical trials will be successful. Clinical results are frequently
susceptible to varying interpretations which may delay, limit or prevent
regulatory approvals. The length of time necessary to complete clinical
trials and from submission of an application for marketing approval to a
final decision by a regulatory authority varies significantly and may be
difficult to predict.
- Uncertainties Surrounding Proprietary Rights. The patent positions
of pharmaceutical and biotechnology companies can be highly uncertain
and involve complex legal and factual questions. Accordingly the breadth
of claims allowed in such company's patents cannot be predicted. Patent
disputes are frequent and can preclude commercialization of products.
The Company has in the past and may in the future be involved in
material patent litigation. Such litigation is costly in its own right
and could subject the Company to significant liabilities to third
parties and, if decided adversely, the Company may need to obtain third
party licenses or cease using the technology or product in dispute.
