UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
FORM 10-Q
(Mark One)
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2001
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission file number 000-12477
AMGEN INC.
(Exact name of registrant as specified in its charter)
Delaware 95-3540776
- ------------------------------- -----------------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
One Amgen Center Drive, Thousand Oaks, California 91320-1799
- -------------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (805) 447-1000
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No
As of March 31, 2001, the registrant had 1,043,163,099 shares of Common Stock,
$0.0001 par value, outstanding.
AMGEN INC.
INDEX
Page No.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements................................ 3
Condensed Consolidated Statements of
Operations - three months
ended March 31, 2001 and 2000........................... 4
Condensed Consolidated Balance Sheets -
March 31, 2001 and December 31, 2000..................... 5
Condensed Consolidated Statements of
Cash Flows - three months
ended March 31, 2001 and 2000............................ 6
Notes to Condensed Consolidated Financial
Statements............................................... 7
Item 2. Management's Discussion and Analysis
of Financial Condition and Results of
Operations.......................................... 12
PART II OTHER INFORMATION
Item 1. Legal Proceedings................................... 18
Item 6. Exhibits and Reports on Form 8-K.................... 18
Signatures.................................................. 19
Index to Exhibits........................................... 20
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
The information in this report for the three months ended March 31,
2001 and 2000 is unaudited but includes all adjustments (consisting only of
normal recurring accruals, unless otherwise indicated) which Amgen Inc. ("Amgen"
or the "Company") considers necessary for a fair presentation of the results of
operations for those periods.
The condensed consolidated financial statements should be read in
conjunction with the Company's financial statements and the notes thereto
contained in the Company's Annual Report on Form 10-K for the year ended
December 31, 2000.
Interim results are not necessarily indicative of results for the full
fiscal year.
3
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In millions, except per share data)
(Unaudited)
Three Months Ended
March 31,
2001 2000
---------------- ----------------
Revenues:
Product sales $798.4 $697.6
Corporate partner revenues 51.1 74.2
Royalty income 52.1 42.3
---------------- ----------------
Total revenues 901.6 814.1
---------------- ----------------
Operating expenses:
Cost of sales 89.4 85.7
Research and development 206.7 189.8
Selling, general and administrative 196.2 169.7
(Earnings) loss of affiliates, net (7.2) 16.4
---------------- ----------------
Total operating expenses 485.1 461.6
---------------- ----------------
Operating income 416.5 352.5
Other income (expense):
Interest and other income 49.1 36.4
Interest expense, net (4.3) (4.2)
---------------- ----------------
Total other income 44.8 32.2
---------------- ----------------
Income before income taxes 461.3 384.7
Provision for income taxes 156.4 118.5
---------------- ----------------
Net income $304.9 $266.2
================ ================
Earnings per share:
Basic $0.29 $0.26
Diluted $0.28 $0.25
Shares used in calculation of earnings per share:
Basic 1,041.1 1,023.1
Diluted 1,086.2 1,085.7
See accompanying notes.
4
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per share data)
(Unaudited)
March 31, December 31,
2001 2000
------------------- --------------------
ASSETS
------
Current assets:
Cash and cash equivalents $ 478.9 $ 226.5
Marketable securities 1,813.5 1,801.6
Trade receivables, net 431.7 389.2
Inventories 352.2 305.2
Other current assets 187.6 214.6
------------------- --------------------
Total current assets 3,263.9 2,937.1
Property, plant and equipment at cost, net 1,810.9 1,781.5
Other assets 617.3 681.0
------------------- --------------------
$ 5,692.1 $ 5,399.6
=================== ====================
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current liabilities:
Accounts payable $ 96.9 $ 143.2
Commercial paper 99.2 99.7
Accrued liabilities 623.0 619.2
------------------- --------------------
Total current liabilities 819.1 862.1
Long-term debt 223.0 223.0
Stockholders' equity:
Preferred stock; $0.0001 par value; 5.0 shares
authorized; none issued or outstanding - -
Common stock and additional paid-in capital;
$0.0001 par value; 2,750.0 shares authorized;
outstanding - 1,043.2 shares in 2001 and
1,037.4 shares in 2000 3,094.1 2,947.3
Retained earnings 1,533.6 1,304.6
Accumulated other comprehensive income 22.3 62.6
------------------- --------------------
Total stockholders' equity 4,650.0 4,314.5
------------------- --------------------
$ 5,692.1 $ 5,399.6
=================== ====================
See accompanying notes.
5
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
Three Months Ended
March 31,
2001 2000
------------------- -----------------
Cash flows from operating activities:
Net income $ 304.9 $ 266.2
Depreciation and amortization 59.9 50.8
Tax benefits related to employee stock options 72.0 67.8
Gain on equity investments (12.4) (12.1)
(Earnings) loss of affiliates, net (7.2) 16.4
Cash provided by (used in):
Trade receivables, net (42.5) 153.1
Inventories (47.0) (53.3)
Other current assets 30.2 (26.1)
Accounts payable (46.3) 25.3
Accrued liabilities 3.8 (126.0)
------------------ -----------------
Net cash provided by operating activities 315.4 362.1
------------------ -----------------
Cash flows from investing activities:
Purchases of property, plant and equipment (86.9) (92.5)
Proceeds from sales of marketable securities 138.6 172.8
Purchases of marketable securities (129.0) (326.1)
Other 21.7 (16.3)
------------------ -----------------
Net cash used in investing activities (55.6) (262.1)
------------------ -----------------
Cash flows from financing activities:
Net proceeds from issuance of common stock upon the
exercise of employee stock options and in
connection with an employee stock purchase plan 74.8 126.7
Repurchases of common stock (75.9) (225.1)
Other (6.3) (6.7)
------------------ -----------------
Net cash used in financing activities (7.4) (105.1)
------------------ -----------------
Increase (decrease) in cash and cash equivalents 252.4 (5.1)
Cash and cash equivalents at beginning of period 226.5 130.9
------------------ -----------------
Cash and cash equivalents at end of period $ 478.9 $ 125.8
================== =================
See accompanying notes.
6
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2001
1. Summary of significant accounting policies
Business
Amgen Inc. ("Amgen" or the "Company") is a global biotechnology company
that discovers, develops, manufactures and markets human therapeutics based on
advances in cellular and molecular biology.
Principles of consolidation
The consolidated financial statements include the accounts of the Company
and its wholly owned subsidiaries as well as affiliated companies in which the
Company has a controlling financial interest and exercises control over their
operations ("majority controlled affiliates"). All material intercompany
transactions and balances have been eliminated in consolidation. Investments in
affiliated companies which are 50% or less owned and where the Company exercises
significant influence over operations are accounted for using the equity method.
All other equity investments are accounted for under the cost method. The
caption "(Earnings) loss of affiliates, net" includes Amgen's equity in the
operating results of affiliated companies and the minority interest others hold
in the operating results of Amgen's majority controlled affiliates.
Inventories
Inventories are stated at the lower of cost or market. Cost is determined
in a manner which approximates the first-in, first-out (FIFO) method.
Inventories consist of currently marketed products and product candidates which
the Company expects to commercialize. The inventory balance of such product
candidates totaled $155.8 million and $112.7 million as of March 31, 2001 and
December 31, 2000, respectively. Inventories are shown net of applicable
reserves and allowances. Inventories consisted of the following (in millions):
March 31, December 31,
2001 2001
------------ ------------
Raw materials $ 23.0 $ 29.4
Work in process 267.5 238.7
Finished goods 61.7 37.1
------------ ------------
$ 352.2 $ 305.2
============ ============
7
Product sales
Product sales primarily consist of sales of EPOGEN(R) (Epoetin alfa) and
NEUPOGEN(R) (Filgrastim).
The Company has the exclusive right to sell Epoetin alfa for dialysis,
diagnostics and all non-human uses in the United States. The Company sells
Epoetin alfa under the brand name EPOGEN(R). Amgen has granted to Ortho
Pharmaceutical Corporation (which has assigned its rights under the product
license agreement to Ortho Biotech Products, L.P.), a subsidiary of Johnson &
Johnson ("Johnson & Johnson"), a license relating to Epoetin alfa for sales in
the United States for all human uses except dialysis and diagnostics. Pursuant
to this license, the Company and Johnson & Johnson are required to compensate
each other for Epoetin alfa sales that either party makes into the other party's
exclusive market, sometimes referred to as "spillover" sales. Accordingly, Amgen
does not recognize product sales it makes into the exclusive market of Johnson &
Johnson and does recognize the product sales made by Johnson & Johnson into
Amgen's exclusive market. Sales in Amgen's exclusive market are derived from the
Company's sales to its customers, as adjusted for any spillover sales. The
Company is employing an audit methodology to measure each party's spillover
sales based in part on estimates of and subsequent adjustments thereto of third-
party data on shipments to end users and their usage. Sales of the Company's
other products are recognized when shipped and title has passed.
Derivative instruments
The Company adopted Statement of Financial Accounting Standards ("SFAS")
No. 133, "Accounting for Derivative Instruments and Hedging Activities", as
amended, on January 1, 2001 and its adoption has not had a material effect on
the Company's financial statements. SFAS No. 133 requires companies to recognize
all of its derivative instruments as either assets or liabilities in the balance
sheet at fair value. The accounting for changes in the fair value (i.e.,
unrealized gains or losses) of a derivative instrument depends on whether it has
been designated and qualifies as part of a hedging relationship and further, on
the type of hedging relationship. Derivatives that are not hedges must be
adjusted to fair value through current earnings.
To protect against possible changes in values of certain anticipated
foreign currency cash flows, primarily resulting from sales outside the U.S.,
the Company enters into foreign currency forward contracts which qualify and are
designated as cash flow hedges. No portions of these foreign currency forward
contracts are excluded from the assessment of hedge effectiveness, and there are
no ineffective portions of these hedging instruments. The gains and losses on
these forward contracts are reported as a component of other comprehensive
income and reclassified into earnings in the same periods during which the
hedged transactions affect earnings. At March 31, 2001, amounts in accumulated
other comprehensive income related to cash flow hedges were not material.
To protect against possible reductions in value of certain of its
available-for-sale marketable equity securities, the Company has entered into
equity forward contracts which qualify and are
8
designated as fair value hedges. The gains and losses on these forward contracts
as well as the offsetting losses and gains on the hedged equity securities are
recognized in current earnings. During the three months ended March 31, 2001,
gains and losses on the portions of these forwards excluded from the assessment
of hedge effectiveness and the ineffective portions of these hedging instruments
were not material.
The Company has additional foreign currency forward contracts to reduce
exposures to foreign currency fluctuations of certain assets and liabilities
denominated in foreign currencies. However, these contracts have not been
designated as hedges under SFAS No. 133.
Prior to the adoption of SFAS No. 133, all of the Company's foreign
exchange forward contracts were adjusted to fair value through current earnings.
Foreign exchange option contracts that hedged anticipated foreign currency
transactions were deferred and recognized in the same period as the hedged
transaction. In addition, derivatives that hedged against possible reductions in
the fair values of available-for-sale equity securities were included in the
basis of the hedged securities and adjusted to fair value through other
comprehensive income.
Employee stock option and stock purchase plans
The Company's employee stock option and stock purchase plans are accounted
for under Accounting Principles Board Opinion No. 25, "Accounting for Stock
Issued to Employees".
Earnings per share
Basic earnings per share is based upon the weighted-average number of
common shares outstanding. Diluted earnings per share is based upon the
weighted-average number of common shares and dilutive potential common shares
outstanding. Potential common shares are outstanding options under the Company's
employee stock option plans, restricted stock and potential issuances of stock
under the employee stock purchase plan (collectively "dilutive securities")
which are included under the treasury stock method.
9
The following table sets forth the computation for basic and diluted
earnings per share (in millions, except per share information):
Three Months Ended
March 31,
2001 2000
------------------ ----------------
Numerator for basic and diluted
earnings per share - net income $304.9 $266.2
================== ================
Denominator:
Denominator for basic earnings
per share - weighted-average shares 1,041.1 1,023.1
Effect of dilutive securities 45.1 62.6
------------------ ----------------
Denominator for diluted earnings
per share - adjusted weighted-
average shares 1,086.2 1,085.7
================== ================
Basic earnings per share $0.29 $0.26
Diluted earnings per share $0.28 $0.25
Use of estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results may differ from those estimates.
Basis of presentation
The financial information for the three months ended March 31, 2001 and
2000 is unaudited but includes all adjustments (consisting only of normal
recurring accruals, unless otherwise indicated) which the Company considers
necessary for a fair presentation of the results of operations for these
periods. Interim results are not necessarily indicative of results for the full
fiscal year.
Reclassification
Certain prior year amounts have been reclassified to conform to the current
year presentation.
2. Stockholders' equity
The Company has a stock repurchase program primarily to reduce the dilutive
effect of its employee stock option and stock purchase plans. Stock repurchased
under the program is intended to be
10
retired. During the three months ended March 31, 2001, the Company repurchased
1.5 million shares of its common stock at a total cost of $75.9 million under
its common stock repurchase program. In December 2000, the Board of Directors
authorized the Company to repurchase up to $2.0 billion of common stock between
January 1, 2001 and December 31, 2002. The amount the Company spends on and the
number of shares repurchased each quarter varies based on a variety of factors,
including the stock price and blackout periods in which the Company is
restricted from repurchasing shares. As of March 31, 2001, $1,924.1 million was
available for stock repurchases through December 31, 2002.
3. Other comprehensive income/(loss)
SFAS No. 130, "Reporting Comprehensive Income", requires unrealized gains
and losses on the Company's available-for-sale securities, foreign currency
translation adjustments, and unrealized gains and losses on cash flow hedge
instruments to be included in other comprehensive income/(loss). During the
three months ended March 31, 2001 and 2000, total comprehensive income was
$264.6 million and $318.1 million, respectively.
11
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
Liquidity and Capital Resources
The Company had cash, cash equivalents and marketable securities of
$2,292.4 million at March 31, 2001, compared with $2,028.1 million at December
31, 2000. Cash provided by operating activities has been and is expected to
continue to be the Company's primary source of funds. During the three months
ended March 31, 2001, operations provided $315.4 million of cash compared with
$362.1 million during the same period last year.
Capital expenditures totaled $86.9 million for the three months ended
March 31, 2001, compared with $92.5 million for the same period a year ago. The
Company anticipates spending approximately $450 million to $550 million in 2001
on capital projects and equipment to expand the Company's global operations.
The Company receives cash from the exercise of employee stock options and
proceeds from the sale of stock by Amgen pursuant to the employee stock purchase
plan. During the three months ended March 31, 2001, employee stock option
exercises and proceeds from the sale of stock by Amgen pursuant to the employee
stock purchase plan provided $74.8 million of cash compared with $126.7 million
for the same period last year. Proceeds from the exercise of employee stock
options will vary from period to period based upon, among other factors,
fluctuations in the market value of the Company's stock relative to the exercise
price of such options.
The Company has a stock repurchase program primarily to reduce the dilutive
effect of its employee stock option and stock purchase plans. During the three
months ended March 31, 2001, the Company purchased 1.5 million shares of its
common stock at a total cost of $75.9 million compared with 3.5 million shares
purchased at a cost of $225.1 million during the same period last year. In
December 2000, the Board of Directors authorized the Company to repurchase up to
$2.0 billion of common stock between January 1, 2001 and December 31, 2002. The
amount the Company spends on and the number of shares repurchased each quarter
varies based on a variety of factors, including the stock price and blackout
periods in which the Company is restricted from repurchasing shares. As of
March 31, 2001, $1,924.1 million was available for stock repurchases through
December 31, 2002.
To provide for financial flexibility and increased liquidity, the Company
has established several sources of debt financing. As of March 31, 2001, the
Company had $223.0 million of unsecured long-term debt securities outstanding.
These unsecured long-term debt securities consisted of: 1) $100 million of debt
securities that bear interest at a fixed rate of 6.5% and mature in 2007 under a
$500 million debt shelf registration (the "Shelf"), 2) $100 million of debt
securities that bear interest at a fixed rate of 8.1% and mature in 2097 and 3)
$23 million of debt securities that bear interest at a fixed rate of 6.2% and
mature in 2003. Under the Shelf, all of the
12
remaining $400 million of debt securities available for issuance may be offered
under the Company's medium-term note program with terms to be determined by
market conditions.
The Company's sources of debt financing also include a commercial paper
program which provides for unsecured short-term borrowings up to an aggregate
face amount of $200 million. As of March 31, 2001, commercial paper with a face
amount of $100.0 million was outstanding. These borrowings had maturities of
less than four months and had effective interest rates averaging 5.0%. In
addition, the Company has an unsecured $150 million credit facility that expires
on May 28, 2003. This credit facility supports the Company's commercial paper
program. As of March 31, 2001, no amounts were outstanding under this line of
credit.
The primary objectives for the Company's investment portfolio are liquidity
and safety of principal. Investments are made to achieve the highest rate of
return to the Company, consistent with these two objectives. The Company's
investment policy limits investments to certain types of instruments issued by
institutions with investment grade credit ratings and places restrictions on
maturities and concentration by type and issuer.
The Company believes that existing funds, cash generated from operations
and existing sources of debt financing are adequate to satisfy its working
capital and capital expenditure requirements for the foreseeable future, as well
as to support its stock repurchase program. However, the Company may raise
additional capital from time to time.
Results of Operations
Product sales
Product sales were $798.4 million during the three months ended March 31,
2001, an increase of $100.8 million or 14% over the same period last year.
Quarterly product sales are influenced by a number of factors, including demand,
wholesaler inventory management practices and foreign exchange effects.
EPOGEN(R) (Epoetin alfa)
EPOGEN(R) sales were $503.1 million for the three months ended March 31,
2001, an increase of $62.7 million or 14% over the same period last year. This
increase was primarily due to demand, which was principally driven by growth in
the U.S. dialysis patient population and the effect of higher prices. The
Company believes that demand growth has slowed somewhat to a high-single to low-
double digit rate. In addition, sales growth over the prior year was, to a
lesser extent, favorably impacted by a reduction in sales in the first quarter
of 2000 due to Year 2000-related sales to wholesalers in the fourth quarter of
1999 for which the Company provided extended payment terms and, the Company
believes, by dialysis provider inventory drawdowns in 2000 of additional 1999
year-end stockpiling.
13
The Company believes that some of this dialysis provider stockpiling may have
been due to Year 2000 concerns and year-end contract expirations.
NEUPOGEN(R) (Filgrastim)
Worldwide NEUPOGEN(R) sales were $294.0 million for the three months ended
March 31, 2001, an increase of $44.0 million or 18% from the same period last
year. This increase was primarily due to reduced sales in the first quarter of
2000 resulting from the adverse impact of Year 2000-related sales to wholesalers
in the fourth quarter of 1999 for which the Company provided extended payment
terms, additional wholesaler inventory drawdowns in 2000, and, to a lesser
extent, higher demand in the current year period. These factors were slightly
offset by the negative impact of a stronger U.S. dollar on international sales.
The Company believes that demand, which includes the effect of higher prices in
the U.S., continued to grow at a mid-single digit rate.
Corporate partner revenues
During the three months ended March 31, 2001, corporate partner revenues
decreased $23.1 million or 31% from the same period last year. This decrease was
primarily due to higher revenues in the first quarter of 2000 from Kirin-Amgen,
Inc. related to the successful completion of the ARANESP(TM) (darbepoetin alfa)
renal development program, the Company's novel erythropoiesis stimulating
protein.
Cost of sales
Cost of sales as a percentage of product sales was 11.2% and 12.3% for the
three months ended March 31, 2001 and 2000, respectively. The decrease in this
percentage was primarily due to reduced costs and increased manufacturing
efficiencies.
Research and development
During the three months ended March 31, 2001, research and development
expenses increased $16.9 million or 9% over the same period last year. This
increase was primarily due to higher staff-related costs necessary to support
ongoing product development activities. This increase was partially offset by
lower product licensing costs.
Selling, general and administrative
Selling, general and administrative ("SG&A") expenses increased $26.5
million or 16% during the three months ended March 31, 2001 over the same period
last year. This increase was primarily due to higher staff-related costs and
outside marketing expenses as the Company continues to support its existing
products and prepares for anticipated new product launches.
14
(Earnings) loss of affiliates, net
During the three months ended March 31, 2001, (earnings) loss of
affiliates, net decreased $23.6 million or 144% compared with the same period
last year. This decrease was primarily due to higher expenses incurred by Kirin-
Amgen, Inc. in the first quarter of 2000 (see "- Corporate partner revenues").
Interest and other income
During the three months ended March 31, 2001, interest and other income
increased $12.7 million or 35% over the same period last year. This increase was
primarily due to higher interest income generated from the Company's investment
portfolio as a result of higher average cash balances.
Income taxes
The Company's effective tax rate for the three months ended March 31, 2001
was 33.9% compared with 30.8% for the same period last year. The Company's tax
rate has increased primarily as a result of increased taxable income combined
with a provision in the federal tax law that caps tax benefits associated with
the Company's Puerto Rico operations at the 1995 income level.
Financial Outlook
In December 1999 and early 2000, the Company filed regulatory submissions
for the use of ARANESP(TM) in patients with chronic renal insufficiency and
chronic renal failure in the U.S., the European Union, Canada, Australia and New
Zealand. The Company anticipates selling ARANESP(TM), if approved, in most of
these markets beginning in 2001. Because the Company is unable to predict the
timing and the extent to which health care providers in the U.S. may transition
from administering EPOGEN(R) to ARANESP(TM), sales guidance for EPOGEN(R) and
ARANESP(TM) will be provided on a combined basis. The Company expects the
percentage increase of 2001 sales of EPOGEN(R) and ARANESP(TM) combined over
2000 EPOGEN(R) sales to be in the low-teens. This growth rate is lower than
previous guidance of growth in a range of high-teens to low-twenties principally
due to a reduced forecast for U.S. dialysis and non-dialysis sales of
ARANESP(TM) due to the longer than planned FDA approval timeline for
ARANESP(TM), and lower than expected U.S. dialysis patient population growth.
The Company now expects its U.S. dialysis business to grow at a mid to high-
single digit rate, reduced from a previously expected low-double digit rate.
Patients receiving treatment for end stage renal disease are covered primarily
under medical programs provided by the federal government. Therefore, EPOGEN(R)
sales may also be affected by future changes in reimbursement rates or a change
in the basis for reimbursement by the federal government. In addition,
ARANESP(TM) sales will be affected by government and private payor reimbursement
policies.
15
In 2001, the Company expects the NEUPOGEN(R) sales growth rate to be in the
high-single digits. The Company believes that there has been and may continue to
be a trend in some cancer settings towards the use of chemotherapy treatments
that are less myelosuppressive. Chemotherapy treatments that are less
myelosuppressive may require less NEUPOGEN(R). Future NEUPOGEN(R) demand is
dependent primarily upon penetration of existing markets and the effects of
competitive products. NEUPOGEN(R) 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(R) sales will continue
to be affected by changes in foreign currency exchange rates. In both domestic
and foreign markets, sales of NEUPOGEN(R) are dependent, in part, on the
availability of reimbursement from third party payors such as governments (for
example, Medicare and Medicaid programs in the U.S.) and private insurance
plans. Therefore, NEUPOGEN(R) sales may also be affected by future changes in
reimbursement rates or changes in the bases for reimbursement.
The Company has revised its guidance for 2001 total product sales growth
from a mid to high-teens rate to a low-double digit rate. For 2001, cost of
sales is expected to be in the range of 11.5% to 12.5% of total product sales,
corporate partner revenues are expected to be approximately the same as in 2000,
research and development expenses and SG&A expenses are each estimated to be in
the range of 25% to 27% of total product sales, and the effective tax rate is
expected to be approximately 34%. Reflecting the expected slower sales growth,
the Company has revised its guidance for earnings per share growth from a mid-
teens rate to a low-double digit rate.
Estimates of future product sales, operating expenses and earnings per
share are necessarily speculative in nature and are difficult to predict with
accuracy. The Company is providing this information as of the filing date of
this Form 10-Q, and does not plan to update this information until its next Form
10-Q filing with the Securities and Exchange Commission and expressly disclaims
any duty to update the information contained in this filing.
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,
earnings per share and expenses. 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) intellectual property
matters (patents) and the
16
results of litigation; (vi) competition; (vii) fluctuations in operating results
and (viii) rapid growth of the Company. These factors and others are discussed
herein and in Exhibit 99 filed with this report titled "Factors That May Affect
Amgen" and incorporated herein by reference.
17
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
Certain of the Company's legal proceedings are reported in the Company's
Annual Report on Form 10-K for the year ended December 31, 2000, with material
developments since that report described below. While it is not possible to
predict accurately or to determine the eventual outcome of these matters, the
Company believes that the outcome of these proceedings will not have a material
adverse effect on the annual financial statements of the Company.
Biogen litigation
On April 4, 2001, the United States District Court for the District of
Massachusetts (the "Massachusetts District Court") entered an order denying
Biogen Inc.'s motion for reconsideration of the Massachusetts District Court's
March 1, 2001 Order granting the Company's motion to amend the Massachusetts
District Court's September 25, 2000 Memorandum and Order.
Item 6. Exhibits and Reports on Form 8-K
(a) Reference is made to the Index to Exhibits included herein.
(b) Reports on Form 8-K - none
18
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 thereunto duly authorized.
Amgen Inc.
(Registrant)
Date: 5/14/01 By: /s/ Kathryn E. Falberg
- ------------------ -------------------------------
Kathryn E. Falberg
Senior Vice President, Finance
and Chief Financial Officer
Date: 5/14/01 By: /s/ Barry D. Schehr
- ------------------ -------------------------------
Barry D. Schehr
Vice President, Financial
Operations, and
Chief Accounting Officer
19
AMGEN INC.
INDEX TO EXHIBITS
Exhibit No. Description
3.1 Restated Certificate of Incorporation as amended. (10)
3.2 Amended and Restated Bylaws of Amgen Inc. (as amended October 24,
2000). (20)
3.3 Certificate of Amendment of Restated Certificate of Incorporation.
(19)
3.4 Certificate of Designations of Series A Junior Participating
Preferred Stock. (22)
4.1 Indenture dated January 1, 1992 between the Company and Citibank
N.A., as trustee. (4)
4.2 First Supplement to Indenture, dated February 26, 1997 between the
Company and Citibank N.A., as trustee. (7)
4.3 Officer's Certificate pursuant to Sections 2.1 and 2.3 of the
Indenture, as supplemented, establishing a series of securities
"8-1/8% Debentures due April 1, 2097." (9)
4.4 8-1/8% Debentures due April 1, 2097. (9)
4.5 Form of stock certificate for the common stock, par value $.0001
of the Company. (10)
4.6 Officer's Certificate pursuant to Sections 2.1 and 2.3 of the
Indenture, dated as of January 1, 1992, as supplemented by the
First supplemental Indenture, dated as of February 26, 1997, each
between the Company and Citibank, N.A., as Trustee, establishing a
series of securities entitled "6.50% Notes Due December 1, 2007".
(12)
4.7 6.50% Notes Due December 1, 2007 described in Exhibit 4.6. (12)
4.8 Corporate Commercial Paper - Master Note between and among Amgen
Inc., as Issuer, Cede & Co., as nominee of The Depository Trust
Company and Citibank, N.A. as Paying Agent. (14)
10.1 Company's Amended and Restated 1991 Equity Incentive Plan. (22)
10.2 Company's Amended and Restated 1997 Special Non-Officer Equity
Incentive Plan. (22)
10.3 Shareholder's Agreement of Kirin-Amgen, Inc., dated May 11, 1984,
between the Company and Kirin Brewery Company, Limited. (22)
10.4 Amendment Nos. 1, 2, and 3, dated March 19, 1985, July 29, 1985
and December 19, 1985, respectively, to the Shareholder's
Agreement of Kirin-Amgen, Inc., dated May 11, 1984. (19)
10.5 Product License Agreement, dated September 30, 1985, and
Technology License Agreement, dated, September 30, 1985 between
the Company and Ortho Pharmaceutical Corporation. (19)
10.6 Product License Agreement, dated September 30, 1985, and
Technology License Agreement, dated September 30, 1985
20
between Kirin-Amgen, Inc. and Ortho Pharmaceutical Corporation.
(19)
10.7 Company's Amended and Restated Employee Stock Purchase Plan. (19)
10.8 Research, Development Technology Disclosure and License Agreement
PPO, dated January 20, 1986, by and between the Company and Kirin
Brewery Co., Ltd. (1)
10.9 Amendment Nos. 4 and 5, dated October 16, 1986 (effective July 1,
1986) and December 6, 1986 (effective July 1, 1986), respectively,
to the Shareholders Agreement of Kirin-Amgen, Inc. dated May 11,
1984. (22)
10.10 Assignment and License Agreement, dated October 16, 1986, between
the Company and Kirin-Amgen, Inc. (22)
10.11 G-CSF European License Agreement, dated December 30, 1986, between
Kirin-Amgen, Inc. and the Company. (22)
10.12 Company's Retirement and Savings Plan (as amended and restated
effective October 23, 2000). (22)
10.13 Company's Amended and Restated 1988 Stock Option Plan. (6)
10.14 First Amendment to the Company's Retirement and Savings Plan (as
amended and restated effective October 23, 2000). (22)
10.15 Amendment, dated June 30, 1988, to Research, Development,
Technology Disclosure and License Agreement: GM-CSF dated March
31, 1987, between Kirin Brewery Company, Limited and the Company.
(2)
10.16 Agreement on G-CSF in Certain European Countries, dated January 1,
1989, between Amgen Inc. and F. Hoffmann-La Roche & Co. Limited
Company (with certain confidential information deleted therefrom).
(3)
10.17 Partnership Purchase Agreement, dated March 12, 1993, between the
Company, Amgen Clinical Partners, L.P., Amgen Development
Corporation, the Class A limited partners and the Class B limited
partner. (5)
10.18 Amgen Inc. Supplemental Retirement Plan (As Amended and Restated
Effective November 1, 1999). (18)
10.19 First Amendment to Amgen Inc. Change of Control Severance Plan.
(19)
10.20 Amended and Restated Amgen Performance Based Management Incentive
Plan. (17)
10.21 Credit Agreement, dated as of May 28, 1998, among Amgen Inc., the
Borrowing Subsidiaries named therein, the Banks named therein,
Citibank, N.A., as Issuing Bank, and Citicorp USA, Inc., as
Administrative Agent. (15)
10.22 G-CSF United States License Agreement dated June 1, 1987
(effective July 1, 1986) between Kirin-Amgen, Inc. and the
Company. (22)
10.23 Amendment No. 1 dated October 20, 1988 to Kirin-Amgen, Inc./Amgen
G-CSF United States License Agreement dated June 1, 1987
(effective July 1, 1986). (22)
10.24 Amendment No. 2 dated October 17, 1991 (effective November 13,
1990) to Kirin-Amgen, Inc./Amgen G-CSF United States License
Agreement dated June 1, 1987 (effective July 1, 1986). (22)
10.25 Amendment No. 10 dated March 1, 1996 to the Shareholders'
Agreement of Kirin-Amgen, Inc. dated May 11, 1984. (22)
21
10.26 Amgen Inc. Change of Control Severance Plan effective as of
October 20, 1998. (16)
10.27 Preferred Share Rights Agreement, dated as of December 12, 2000,
between Amgen Inc. and American Stock Transfer and Trust Company,
as Rights Agent. (21)
10.28 First Amendment, effective January 1, 1998, to the Company's
Amended and Restated Employee Stock Purchase Plan. (11)
10.29 Amendment No. 11 dated March 20, 2000 to the Shareholders'
Agreement of Kirin-Amgen, Inc. dated May 11, 1984. (22)
10.30 Agreement between Amgen Inc. and Dr. Fabrizio Bonanni, dated March
3, 1999. (18)
10.31 Amendment No. 1 dated June 1, 1987 to Kirin-Amgen, Inc./Amgen G-
CSF European License Agreement dated December 30, 1986. (22)
10.32 Amendment No. 2 dated March 15, 1988 to Kirin-Amgen, Inc./Amgen G-
CSF European License Agreement dated December 30, 1986. (22)
10.33 Amendment No. 3 dated October 20, 1988 to Kirin-Amgen, Inc./Amgen
G-CSF European License Agreement dated December 30, 1986. (22)
10.34 Amendment No. 4 dated December 29, 1989 to Kirin-Amgen, Inc./Amgen
G-CSF European License Agreement dated December 30, 1986. (22)
10.35 Company's Amended and Restated 1987 Directors' Stock Option Plan.
(8)
10.36 Amended and Restated Agreement on G-CSF in the EU between Amgen
Inc. and F. Hoffmann-La Roche Ltd (with certain confidential
information deleted therefrom). (14)
10.37 Collaboration and License Agreement, dated December 15, 1997,
between the Company, GPI NIL Holdings, Inc. and Guilford
Pharmaceuticals Inc. (with certain confidential information
deleted therefrom). (13)
10.38 Promissory Note of Dr. Fabrizio Bonanni, dated August 7, 1999.
(18)
10.39 Promissory Note of Dr. Fabrizio Bonanni, dated October 29, 1999.
(18)
10.40 Company's Amended and Restated 1997 Equity Incentive Plan. (22)
10.41 Agreement between Amgen Inc. and Mr. Gordon M. Binder, dated May
10, 2000. (19)
10.42 Amendment No. 6 dated May 11, 1984 to the Shareholders' Agreement
of Kirin-Amgen, Inc. dated May 11, 1984. (22)
10.43 Amendment No. 7 dated July 17, 1987 (effective April 1, 1987) to
the Shareholders' Agreement of Kirin-Amgen, Inc. dated May 11,
1984. (22)
10.44 Amendment No. 8 dated May 28, 1993 (effective November 13, 1990)
to the Shareholders' Agreement of Kirin-Amgen, Inc. dated May 11,
1984. (22)
10.45 Amendment No. 9 dated December 9, 1994 (effective June 14, 1994)
to the Shareholders' Agreement of Kirin-Amgen, Inc. dated May 11,
1984. (22)
10.46* Agreement between Amgen Inc. and Mr. George J. Morrow, dated March
3, 2001.
22
10.47* Promissory Note of Mr. George J. Morrow, dated March 11, 2001.
10.48* Agreement between Amgen Inc. and Dr. Roger M. Perlmutter, M.D.,
Ph.D., dated March 5, 2001.
99* "Factors That May Affect Amgen"
- ----------------
* Filed herewith.
(1) Filed as an exhibit to Amendment No. 1 to Form S-1 Registration
Statement (Registration No. 33-3069) on March 11, 1986 and incorporated
herein by reference.
(2) Filed as an exhibit to Form 8 amending the Quarterly Report on Form
10-Q for the quarter ended June 30, 1988 on August 25, 1988 and
incorporated herein by reference.
(3) Filed as an exhibit to the Form 8 dated November 8, 1989, amending the
Annual Report on Form 10-K for the year ended March 31, 1989 on June
28, 1989 and incorporated herein by reference.
(4) Filed as an exhibit to Form S-3 Registration Statement dated December
19, 1991 and incorporated herein by reference.
(5) Filed as an exhibit to the Form 8-A dated March 31, 1993 and
incorporated herein by reference.
(6) Filed as an exhibit to the Form 10-Q for the quarter ended September
30, 1996 on November 5, 1996 and incorporated herein by reference.
(7) Filed as an exhibit to the Form 8-K Current Report dated March 14, 1997
on March 14, 1997 and incorporated herein by reference.
(8) Filed as an exhibit to the Annual Report on Form 10-K for the year
ended December 31, 1996 on March 24, 1997 and incorporated herein by
reference.
(9) Filed as an exhibit to the Form 8-K Current Report dated April 8, 1997
on April 8, 1997 and incorporated herein by reference.
(10) Filed as an exhibit to the Form 10-Q for the quarter ended March 31,
1997 on May 13, 1997 and incorporated herein by reference.
(11) Filed as an exhibit to the Form 10-Q for the quarter ended June 30,
1997 on August 12, 1997 and incorporated herein by reference.
(12) Filed as an exhibit to the Form 8-K Current Report dated and filed on
December 5, 1997 and incorporated herein by reference.
(13) Filed as Exhibit 10.40 to the Guilford Pharmaceuticals Inc. Form 10-K
for the year ended December 31, 1997 on March 27, 1998 and incorporated
herein by reference.
(14) Filed as an exhibit to the Form 10-Q for the quarter ended March 31,
1998 on May 13, 1998 and incorporated herein by reference.
(15) Filed as an exhibit to the Form 10-Q for the quarter ended June 30,
1998 on August 14, 1998 and incorporated herein by reference.
(16) Filed as an exhibit to the Annual Report on Form 10-K for the year
ended December 31, 1998 on March 16, 1999 and incorporated herein by
reference.
(17) Filed as an exhibit to the Form 10-Q for the quarter ended June 30,
1999 on August 3, 1999 and incorporated herein by reference.
(18) Filed as an exhibit to the Annual Report on Form 10-K for the year
ended December 31, 1999 on March 7, 2000 and incorporated herein by
reference.
(19) Filed as an exhibit to the Form 10-Q for the quarter ended June 30,
2000 on August 1, 2000 and incorporated herein by reference.
23
(20) Filed as an exhibit to the Form 10-Q for the quarter ended September
30, 2000 on November 14, 2000 and incorporated herein by reference.
(21) Filed as an exhibit to the Form 8-K Current Report dated December 13,
2000 on December 18, 2000 and incorporated herein by reference.
(22) Filed as an exhibit to the Annual Report on Form 10-K for the year
ended December 31, 2000 on March 7, 2001 and incorporated herein by
reference.
24