Amgen 2001 Annual Report Download - page 31

AMGEN 2001 ANNUAL REPORT
dent in part upon such factors as the effects of competi-
tive pressures, penetration of existing and new market
opportunities, the availability and extent of reimburse-
ment by third-party payors including governments and
private insurance plans, and changes in foreign currency
exchange rates.
Future NEUPOGEN®demand is dependent primar-
ily upon penetration of existing markets, inflation-
related price increases, and the effects of competitive
products. In addition, chemotherapy treatments that are
less myelosuppressive may require less NEUPOGEN®.
NEUPOGEN®usage is expected to continue to be affected
by cost containment pressures from governments and
private insurers on health care providers worldwide. In
addition, reported NEUPOGEN®sales will continue to be
affected by changes in foreign currency exchange rates. In
both domestic and foreign markets, sales of NEUPOGEN®
are dependent, in part, on the availability of reimburse-
ment from third-party payors such as governments (for
example, Medicare and Medicaid programs in the U.S.)
and private insurance plans. Therefore, NEUPOGEN®
sales may also be affected by future changes in reimburse-
ment rates or changes in the bases for reimbursement.
In January 2002, the Company received regulatory
approval to market Neulasta™
, its new white blood cell
booster, in the U.S. Neulasta™ , administered as a single
fixed dose per chemotherapy cycle, is indicated for
decreasing the incidence of infection, as manifested by
febrile neutropenia in patients with non-myeloid malig-
nancies receiving myelosuppressive anti-cancer drugs
associated with clinically significant incidence of febrile
neutropenia. The Company expects to launch Neulasta™
in April 2002. Once launched, Neulasta™may impact
NEUPOGEN®sales as health care providers in the U.S. may
transition from administering NEUPOGEN®to Neulasta™ .
In November 2001, the Company received regula-
tory approval to market Kineret™(anakinra) in the U.S.
for the reduction in signs and symptoms of moderately
to severely active rheumatoid arthritis in adult patients
who have failed one or more disease modifying anti-
rheumatic drugs.
The Company is providing this information as of
the filing date of the Company’s Annual Report on
Form 10-K for the year ended December 31, 2001, and
does not plan to update this information and expressly
disclaims any duty to update the information contained
herein, except as required by law.
Except for the historical information contained
herein, the matters discussed herein are by their nature
forward-looking. Investors are cautioned that forward-
looking statements or projections made by the Company,
including those made in this document, are subject to
risks and uncertainties that may cause actual results to
differ materially from those projected. Reference is made
in particular to forward-looking statements regarding
product sales, expenses, liquidity and the Convertible
Notes, and the proposed merger with Immunex.
Amgen operates in a rapidly changing environment that
involves a number of risks, some of which are beyond
the Company’s control. Future operating results and the
Company’s stock price may be affected by a number of
factors, including, without limitation: (i) the results of
preclinical and clinical trials; (ii) regulatory approvals of
product candidates, new indications, and manufacturing
facilities; (iii) health care guidelines and policies relating
to Amgen’s products; (iv) reimbursement for Amgen’s
products by governments and private payors; (v) intellec-
tual property matters (patents) and the results of litiga-
tion; (vi) competition; (vii) fluctuations in operating
results; and (viii) rapid growth of the Company. The
proposed merger with Immunex may fail to close or the
terms of the merger may need to be modified to achieve
regulatory approval. Depending on the timing of the
merger, and other factors, Amgen may not realize all
of the anticipated benefits of the merger, including the
anticipated synergies, cost savings, and growth opportu-
nities from integrating the businesses of Immunex with
the businesses of Amgen. Additionally, the value of the
Amgen common stock to be issued to the Immunex
shareholders in connection with the merger will fluctu-
ate. These factors and others are discussed in the sections
appearing under the heading “Business – Factors That
May Affect Amgen” in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2001,
and in Amgen’s other filings with the Securities and
Exchange Commission, which sections are incorporated
herein by reference.
Summary of Critical Accounting Policies
EPOGEN®revenue recognition
The Company has the exclusive right to sell Epoetin alfa
for dialysis, certain diagnostics, and all non-human, non-
research uses in the United States. Amgen has granted
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