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, 2000
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission file number 0-12477
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, 2000, the registrant had 1,026,769,316 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, 2000 and 1999.............. 4
Condensed Consolidated Balance Sheets -
March 31, 2000 and December 31, 1999....... 5
Condensed Consolidated Statements of
Cash Flows - three months
ended March 31, 2000 and 1999.............. 6
Notes to Condensed Consolidated Financial
Statements................................. 7
Item 2. Management's Discussion and Analysis
of Financial Condition and Results of
Operations........................... 14
PART II OTHER INFORMATION
Item 1. Legal Proceedings.................... 20
Item 6. Exhibits and Reports on Form 8-K..... 21
Signatures................................... 22
Index to Exhibits............................ 23
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
The information in this report for the three months ended March 31, 2000
and 1999 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, 1999.
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,
2000 1999
----------------- ------------------
Revenues:
Product sales $ 697.6 $ 688.3
Corporate partner revenues 74.2 27.0
Royalty income 42.3 30.2
----------------- ------------------
Total revenues 814.1 745.5
----------------- ------------------
Operating expenses:
Cost of sales 85.7 92.4
Research and development 189.8 188.0
Selling, general and administrative 169.7 132.9
Loss of affiliates, net 16.4 2.8
----------------- ------------------
Total operating expenses 461.6 416.1
----------------- ------------------
Operating income 352.5 329.4
Other income (expense):
Interest and other income 36.4 18.5
Interest expense, net (4.2) (2.2)
----------------- ------------------
Total other income 32.2 16.3
----------------- ------------------
Income before income taxes 384.7 345.7
Provision for income taxes 118.5 98.5
----------------- ------------------
Net income $ 266.2 $ 247.2
================= ==================
Earnings per share:
Basic $ 0.26 $ 0.24
Diluted $ 0.25 $ 0.23
Shares used in calculation of earnings per share:
Basic 1,023.1 1,023.5
Diluted 1,085.7 1,080.9
See accompanying notes.
4
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per share data)
(Unaudited)
March 31, December 31,
2000 1999
------------------ -----------------
ASSETS
------
Current assets:
Cash and cash equivalents $ 125.8 $ 130.9
Marketable securities 1,353.8 1,202.1
Trade receivables, net 259.1 412.2
Inventories 237.6 184.3
Other current assets 177.3 135.8
------------------ -----------------
Total current assets 2,153.6 2,065.3
------------------ -----------------
Property, plant and equipment at cost, net 1,595.3 1,553.6
Investments in affiliated companies 122.6 132.8
Other equity investments 237.4 129.7
Other assets 155.8 196.2
------------------ -----------------
$4,264.7 $4,077.6
================== =================
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------
Current liabilities:
Accounts payable $ 108.7 $ 83.4
Commercial paper 99.8 99.5
Accrued liabilities 522.2 648.2
------------------ -----------------
Total current liabilities 730.7 831.1
Long-term debt 223.0 223.0
Contingencies
Stockholders' equity:
Preferred stock; $0.0001 par value; 5 shares
authorized; none issued or outstanding - -
Common stock and additional paid-in capital;
$0.0001 par value; 1,500 shares authorized;
outstanding - 1,026.8 shares in 2000 and
1,017.9 shares in 1999 2,266.8 2,072.3
Retained earnings 1,007.1 966.0
Accumulated other comprehensive gain (loss) 37.1 (14.8)
------------------ -----------------
Total stockholders' equity 3,311.0 3,023.5
------------------ -----------------
$4,264.7 $4,077.6
================== =================
See accompanying notes.
5
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
Three Months Ended
March 31,
2000 1999
------------- -------------
Cash flows from operating activities:
Net income $ 266.2 $ 247.2
Depreciation and amortization 50.8 44.4
Gain on equity investments (12.1) -
Loss of affiliates, net 16.4 2.8
Cash provided by (used in):
Trade receivables, net 153.1 (49.7)
Inventories (53.3) (6.4)
Other current assets (26.1) (8.3)
Accounts payable 25.3 (26.5)
Accrued liabilities (126.0) (2.8)
------------- -------------
Net cash provided by operating activities 294.3 200.7
------------- -------------
Cash flows from investing activities:
Purchases of property, plant and equipment (92.5) (76.3)
Proceeds from maturities of marketable securities - 10.3
Proceeds from sales of marketable securities 172.8 206.0
Purchases of marketable securities (326.1) (352.6)
Other (16.3) (0.9)
------------- -------------
Net cash used in investing activities (262.1) (213.5)
------------- -------------
Cash flows from financing activities:
Repayment of long-term debt - (6.0)
Net proceeds from issuance of common stock upon the
exercise of employee stock options and in
connection with an employee stock purchase plan 126.7 98.7
Tax benefits related to employee stock option
exercises 67.8 50.3
Repurchases of common stock (225.1) (202.5)
Other (6.7) (14.7)
------------- -------------
Net cash used in financing activities (37.3) (74.2)
------------- -------------
Decrease in cash and cash equivalents (5.1) (87.0)
Cash and cash equivalents at beginning of period 130.9 201.1
------------- -------------
Cash and cash equivalents at end of period $ 125.8 $ 114.1
============= =============
See accompanying notes.
6
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2000
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 for 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 "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 $42.5 million and $20.3 million as of March 31, 2000 and
December 31, 1999, respectively. Inventories are shown net of applicable
reserves and allowances. Inventories consist of the following (in millions):
March 31, December 31,
2000 1999
------------- --------------
Raw materials $ 40.5 $ 37.5
Work in process 145.5 96.6
Finished goods 51.6 50.2
------------- --------------
$237.6 $184.3
============= ==============
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, Inc.), 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, 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 and
adjustments thereto are derived from Company shipments and from third-party data
on shipments to end users and their usage (see Note 6, "Contingencies - Johnson
& Johnson arbitrations"). Sales of the Company's other products are recognized
when shipped.
Foreign currency transactions
The Company has a program to manage foreign currency risk. As part of this
program, it has purchased foreign currency option and forward contracts to hedge
against possible reductions in values of certain anticipated foreign currency
cash flows generally over the next 12 months, primarily resulting from its sales
in Europe. At March 31, 2000, the Company had option and forward contracts to
exchange foreign currencies for U.S. dollars of $24 million and $65 million,
respectively, all having maturities of eight months or less. The option
contracts, which have only nominal intrinsic value at the time of purchase, are
designated as effective hedges of anticipated foreign currency transactions for
financial reporting purposes and accordingly, the net gains on such contracts
are deferred and recognized in the same period as the hedged transactions. The
forward contracts do not qualify as hedges for financial reporting purposes and
accordingly, are marked-to-market. Net gains on option contracts (including
option contracts for hedged transactions whose occurrence are no longer
probable) and changes in market values of forward contracts are reflected in
"Interest and other income". The deferred premiums on option contracts and fair
values of forward contracts are included in "Other current assets".
The Company has additional foreign currency forward contracts to hedge
exposures to foreign currency fluctuations of certain assets and liabilities
denominated in foreign currencies. At March 31, 2000, the Company had forward
contracts to exchange foreign currencies for U.S. dollars of $35 million, all
having maturities of less than one month. These contracts are designated as
effective hedges and accordingly, gains and losses on these forward contracts
are recognized in the same period the offsetting gains and losses of hedged
assets and liabilities are realized and recognized. The fair values of the
forward contracts are included in the corresponding captions of the hedged
assets and liabilities. Gains and losses on
8
forward contracts, to the extent they differ in amount from the hedged assets
and liabilities, are included in "Interest and other income".
In June 1998, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards ("SFAS") No. 133, "Accounting for Derivative
Instruments and Hedging Activities". The date required for adoption of this
statement has been delayed until fiscal years beginning after June 15, 2000.
Because of the Company's minimal use of derivatives, management anticipates that
the adoption of this new statement will not have a significant effect on
earnings or the financial position of the Company.
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 and potential issuances of stock under the
employee stock purchase plan 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,
2000 1999
------------- -------------
Numerator for basic and diluted
earnings per share - net income $ 266.2 $ 247.2
============= =============
Denominator:
Denominator for basic earnings
per share - weighted-average shares 1,023.1 1,023.5
Effect of dilutive securities -
employee stock options and stock
issuances under the employee stock
purchase plan 62.6 57.4
------------- -------------
Denominator for diluted earnings
per share - adjusted weighted-
average shares 1,085.7 1,080.9
============= =============
Basic earnings per share $ 0.26 $ 0.24
Diluted earnings per share $ 0.25 $ 0.23
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, 2000 and
1999 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.
10
2. Debt
As of March 31, 2000, the Company had $223 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 that were issued in December 1997 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 remaining $400 million of debt
securities available for issuance may be offered under the Company's medium-term
note program from time to time with terms to be determined by market conditions.
The Company has a commercial paper program which provides for unsecured
short-term borrowings up to an aggregate of $200 million. As of March 31, 2000,
commercial paper with a face amount of $100 million was outstanding. These
borrowings had maturities of less than one month and had effective interest
rates averaging 5.6%.
The Company also has an unsecured $150 million credit facility that expires
on May 28, 2003. As of March 31, 2000, no amounts were outstanding under this
line of credit.
3. Income taxes
The provision for income taxes consists of the following (in millions):
Three Months Ended
March 31,
2000 1999
--------------- ------------
Federal (including U.S. possessions) $108.9 $90.7
State 9.6 7.8
--------------- ------------
$118.5 $98.5
=============== ============
The Company's effective tax rate for the three months ended March 31, 2000
was 30.8% compared with 28.5% for the same period last year. The increase in
the effective tax rate in the current year is primarily due to an increase in
the current year's expected pretax income without corresponding increases in the
tax benefits associated with the Company's Puerto Rico operations and research
and experimentation credits.
4. Stockholders' equity
During the three months ended March 31, 2000, the Company repurchased 3.5
million shares of its common stock at a total cost of
11
$225.1 million under its common stock repurchase program. In October 1999, the
Board of Directors authorized the Company to repurchase up to $2 billion of
common stock through December 31, 2000, replacing the remaining amount
authorized in October 1998. 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, 2000, $1,423.1 million was available for
stock repurchases. Stock repurchased under the program is retired.
5. Comprehensive income
During the three months ended March 31, 2000 and 1999, total comprehensive
income was $318.1 million and $234.7 million, respectively. The Company's other
comprehensive income/loss is comprised of unrealized gains and losses on the
Company's available-for-sale securities and foreign currency translation
adjustments.
6. Contingencies
Johnson & Johnson arbitrations
In September 1985, the Company granted Johnson & Johnson's affiliate, Ortho
Pharmaceutical Corporation, a license relating to certain patented technology
and know-how of the Company to sell a genetically engineered form of recombinant
human erythropoietin, called Epoetin alfa, throughout the United States for all
human uses except dialysis and diagnostics. A number of disputes have arisen
between Amgen and Johnson & Johnson as to their respective rights and
obligations under the various agreements between them, including the agreement
granting the license (the "License Agreement").
A dispute between Amgen and Johnson & Johnson that has been the subject of
an arbitration proceeding relates to the audit methodology currently employed by
the Company to account for Epoetin alfa sales. 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 described as
"spillover" sales. The Company has established and is employing an audit
methodology to measure each party's spillover sales and to allocate the net
profits from those sales to the appropriate party. The arbitrator in this matter
(the "Arbitrator") issued an opinion adopting the Company's audit methodology
with certain adjustments and, subsequently, issued his final order confirming
that the Company was the successful party in the arbitration. Pursuant to the
final order in the arbitration, an independent panel was formed principally (i)
to address ongoing challenges to the survey results for the years 1995 through
1999 and (ii) to refine the procedures for measuring the erythropoietin market
as may be necessary. Johnson & Johnson has brought challenges under this
procedure to certain survey results for certain periods. As a result of
decisions made by this independent panel regarding certain of these challenges
as well as other reduced uncertainties, the Company has
12
reduced amounts previously provided for potential spillover liabilities by $49
million in the third quarter of 1999 and $23 million in the fourth quarter of
1998.
Because the Arbitrator ruled that the Company was the successful party in
the arbitration, Johnson & Johnson was ordered to pay to the Company all costs
and expenses, including reasonable attorneys' fees, that the Company incurred in
the arbitration as well as one-half of the audit costs. The Company submitted a
bill for such costs and expenses incurred over an eight year period in the
amount of approximately $110 million. Johnson & Johnson contested substantially
all such costs and expenses. On January 26, 2000, the Arbitrator ruled that the
Company is entitled to recover approximately $77.5 million of its costs and
expenses from Johnson & Johnson. On October 26, 1998, Johnson & Johnson filed a
petition in the Circuit Court of Cook County, Illinois seeking to vacate or
modify the Arbitrator's award to the Company of all costs and expenses,
including reasonable attorney's fees and costs, that the Company incurred in the
arbitration. The Company has filed a motion to dismiss Johnson & Johnson's
petition. That motion remains pending. Due to remaining uncertainties the
Company has not recognized any benefit from the recovery of attorneys' fees and
costs or audit costs.
The Company has filed a demand in the arbitration to terminate Johnson &
Johnson's rights under the License Agreement and to recover damages for breach
of the License Agreement based on the Company's claim that Johnson & Johnson has
intentionally sold PROCRIT(R) (the brand name under which Johnson & Johnson
sells Epoetin alfa) into the Company's exclusive dialysis market. Pursuant to
the Arbitrator's ruling, discovery has commenced. Both the Company and Johnson
& Johnson filed motions for summary judgment which were argued in January 2000.
On March 10, 2000, the Arbitrator denied both motions for summary judgment. A
trial date has been set for February 2001. The Company is unable to predict at
this time the outcome of its demand for termination of the License Agreement or
when it will be resolved.
While it is not possible to predict accurately or determine the eventual
outcome of the above described legal matters or various other legal proceedings
(including patent disputes) involving Amgen, the Company believes that the
outcome of these proceedings will not have a material adverse effect on its
annual financial statements.
13
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
$1,479.6 million at March 31, 2000, compared with $1,333 million at December 31,
1999. 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, 2000, operations provided $294.3 million of cash compared with
$200.7 million during the same period last year.
Capital expenditures totaled $92.5 million for the three months ended March
31, 2000, compared with $76.3 million for the same period a year ago. The
Company anticipates spending approximately $450 million to $550 million in 2000
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, 2000, employee stock option
exercises, their related tax benefits and proceeds from the sale of stock by
Amgen pursuant to the employee stock purchase plan provided $194.5 million of
cash compared with $149 million for the same period last year. Proceeds from
the exercise of employee stock options and their related tax benefits 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, 2000, the Company purchased 3.5 million shares of its
common stock at a cost of $225.1 million compared with 5.9 million shares
purchased at a cost of $202.5 million during the same period last year. In
October 1999, the Board of Directors authorized the Company to repurchase up to
$2 billion of common stock through December 31, 2000, replacing the remaining
amount authorized in October 1998. 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, 2000, $1,423.1 million was
available for stock repurchases.
To provide for financial flexibility and increased liquidity, the Company
has established several sources of debt financing. As of March 31, 2000, the
Company had $223 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 that
were issued in December 1997 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
14
2003. Under the Shelf, all of the remaining $400 million of debt securities
available for issuance may be offered under the Company's medium-term note
program.
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, 2000, commercial paper with a face
amount of $100 million was outstanding. These borrowings had maturities of less
than one month and had effective interest rates averaging 5.6%. 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, 2000, 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 invests its excess
cash in securities with varying maturities to meet projected cash needs.
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 $697.6 million during the three months ended March 31,
2000, an increase of $9.3 million or 1% over the same period last year.
Quarterly product sales volume is influenced by a number of factors, including
underlying demand and wholesaler inventory management practices.
EPOGEN(R) (Epoetin alfa)
EPOGEN(R) sales were $440.4 million for the three months ended March 31,
2000, an increase of $45.5 million or 12% over the same period last year. This
increase was primarily due to higher demand. Sales in the first quarter of 2000
were adversely impacted by approximately $16 million of year 2000-related sales
to wholesalers in the fourth quarter of 1999 for which the Company provided
extended payment terms, as previously reported. The Company believes that sales
in the first quarter of 2000 also were adversely impacted by dialysis provider
inventory drawdowns of approximately $20 million due to additional year-end
stockpiling. The Company
15
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 $250 million for the three months ended
March 31, 2000, a decrease of $37 million or 13% from the same period last year.
Sales in the first quarter of 2000 were adversely impacted by approximately $29
million of year 2000-related sales to wholesalers in the fourth quarter of 1999
for which the Company provided extended payment terms, as previously reported.
The Company believes that sales in the first quarter of 2000 also were adversely
impacted by additional wholesaler inventory drawdowns of approximately $30
million. In addition, sales in the current year period were reduced by
approximately $8 million due to the negative impact of the stronger U.S. dollar
on the Company's international NEUPOGEN(R) sales. These decreases were partially
offset by higher demand, which grew at a low double-digit rate.
Other product sales
Other product sales primarily consist of INFERGEN(R) (Interferon alfacon-
1). INFERGEN(R) sales were $6.9 million for the three months ended March 31,
2000, an increase of $0.6 million or 10% over the same period last year.
INFERGEN(R) was launched in October 1997 for the treatment of chronic hepatitis
C virus infection. There are existing treatments, including combination
therapy, for this infection against which INFERGEN(R) competes. The Company
cannot predict the extent to which it will maintain its share or further
penetrate this market.
Corporate partner revenues
During the three months ended March 31, 2000, corporate partner revenues
increased $47.2 million or 175% compared with the same period last year. This
increase was primarily due to a payment from Kirin-Amgen, Inc. related to the
completion of the NESP renal development program.
Cost of sales
Cost of sales as a percentage of product sales was 12.3% and 13.4% for the
three months ended March 31, 2000 and 1999, respectively. This decrease as a
percentage of product sales was due in part to increased manufacturing
efficiencies.
16
Research and development
During the three months ended March 31, 2000, research and development
expenses increased $1.8 million or 1% compared with the same period last year.
This increase was primarily due to higher staff-related costs necessary to
support ongoing product development activities and higher clinical trial costs.
These increases were substantially offset by a reduction in clinical
manufacturing and product licensing costs and the impact of a property tax
refund in the current year.
Selling, general and administrative
Selling, general and administrative expenses increased $36.8 million or 28%
during the three months ended March 31, 2000 compared with 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.
Loss of affiliates, net
During the three months ended March 31, 2000, loss of affiliates, net
increased $13.6 million or 486% compared with the same period last year. This
increase was primarily due to higher expenses for Kirin-Amgen, Inc. (see "-
Corporate partner revenues").
Interest and other income
During the three months ended March 31, 2000, interest and other income
increased $17.9 million or 97% compared with the same period last year. This
increase was primarily due to gains realized on the Company's portfolio of
equity investments and increased interest income generated from the Company's
investment portfolio as a result of higher average cash balances and higher
interest rates.
Income taxes
The Company's effective tax rate for the three months ended March 31, 2000
was 30.8% compared with 28.5% for the same period last year. The increase in
the effective tax rate in the current year is primarily due to an increase in
the current year's expected pretax income without corresponding increases in the
tax benefits associated with the Company's Puerto Rico operations and research
and experimentation credits.
Foreign currency transactions
The Company has a program to manage certain portions of its exposure to
fluctuations in foreign currency exchange rates arising from international
operations. The Company generally hedges the receivables and payables with
foreign currency forward contracts, which typically mature within one to three
months. The Company uses foreign currency option and forward contracts which
generally expire within 12 months to hedge certain anticipated future sales and
expenses. At March 31, 2000, outstanding foreign currency option and forward
contracts totaled $24 million and $100 million, respectively.
17
Financial Outlook
The Company expects the EPOGEN(R) sales growth rate in 2000 to be in the
low teens due to higher demand partially offset by dialysis provider inventory
drawdowns and wholesaler inventory effects in the first quarter of 2000 (see
"Results of Operations - Product sales - EPOGEN(R) (Epoetin alfa)"). As average
hematocrits have risen, the rate of demand growth has slowed and the Company
expects this trend to continue in the future. 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 their fiscal year 2001 budget, the Clinton administration has proposed a
Medicare cost savings plan which includes a provision for cutting Medicare
reimbursement of EPOGEN(R) by 10%. This proposal will be addressed during the
federal government's fiscal year 2001 budget process. The Company believes the
proposal, if enacted, would primarily affect dialysis providers that use
EPOGEN(R) and it is difficult to predict its impact on Amgen.
The Company expects the NEUPOGEN(R) sales growth rate in 2000 to be in the
mid-single digits due to higher demand partially offset by wholesaler inventory
effects in the first quarter of 2000 (see "Results of Operations - Product
sales - NEUPOGEN(R) (Filgrastim)"). Future NEUPOGEN(R) sales growth is dependent
primarily upon further penetration of existing markets, the effects of
competitive products and the timing and nature of additional indications for
which the product may be approved. 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.
In their fiscal year 2001 budget, the Clinton administration has proposed a
reduction in the basis upon which Medicare reimburses for outpatient
prescription drugs from the current 95% of average wholesale price ("AWP") to
83% of AWP. This proposal would impact reimbursement of NEUPOGEN(R). The
Company believes that this new recommendation, if enacted, would primarily
affect customers that use NEUPOGEN(R) and it is difficult to predict its impact
on Amgen.
18
INFERGEN(R) (Interferon alfacon-1) was launched in October 1997 for the
treatment of chronic hepatitis C virus infection. There are other treatments,
including combination therapy, for this infection against which INFERGEN(R)
competes. The Company cannot predict the extent to which it will maintain its
share or further penetrate this market.
In 2000, SG&A expenses are expected to significantly increase as the
Company continues to support its existing products and prepares for anticipated
new product launches.
The Company expects the growth rate for total product sales in 2000 to be
in the high single digits. For 2000, Amgen expects earnings per share to be in
the range of $1.06 to $1.08. Estimates of future product sales, operating
expenses and earnings per share are necessarily speculative in nature and are
difficult to predict with accuracy.
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) reimbursement
for Amgen's products by governments and private payors; (iv) health care
guidelines and policies relating to Amgen's products; (v) intellectual property
matters (patents) and the 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 the sections appearing in "Item
1. Business - Factors That May Affect Amgen" in the Company's Annual Report on
Form 10-K for the year ended December 31, 1999 which sections are incorporated
herein by reference and filed as an exhibit hereto.
Legal Matters
The Company is engaged in arbitration proceedings with one of its
licensees. For a discussion of these matters, see Note 6 to the Condensed
Consolidated Financial Statements.
19
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
The Company is engaged in arbitration proceedings with one of its
licensees. For a discussion of these matters, see Note 6 to the Condensed
Consolidated Financial Statements, "Contingencies". These matters and other
legal proceedings are also reported in the Company's Annual Report on Form 10-K
for the year ended December 31, 1999, with material developments since December
31, 1999 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.
Genentech litigation
Trial is scheduled for December 4, 2000 in the United States District Court
for the Northern District of California.
Transkaryotic Therapies and Aventis S.A. litigation
Amgen's motion for summary judgment of literal infringement was granted by
the United States District Court in Boston, Massachusetts (the "Massachusetts
District Court") on April 26, 2000 with respect to claim 1 of U.S. Patent No.
5,955,422. Also on April 26, 2000, the Massachusetts District Court denied
Amgen's motion for summary judgment with respect to claims 1 and 4 of U.S.
Patent No. 5,756,349 and deferred decision on the infringement of that patent
until trial. Amgen's motion for summary judgment of validity on three of the
patents and defendants' motion for non-infringement of other claims are pending
decision by the Massachusetts District Court. Also pending is Amgen's motion for
summary judgment of no inequitable conduct. Trial is scheduled to begin May 15,
2000 in the Massachusetts District Court.
Securities litigation
On April 12, 2000, the United States District Court for the Central
District of California (the "Central District Court") held a final settlement
hearing. On April 20, 2000, the Central District Court entered a final judgment
approving the settlement and an order dismissing the litigation with prejudice.
Johnson & Johnson arbitrations
The Company is engaged in arbitration proceedings with one of its
licensees. See Note 6 to the Condensed Consolidated Financial Statements,
"Contingencies - Johnson & Johnson arbitrations".
20
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
21
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: 4/27/00 By:/s/Kathryn E. Falberg
- ------------------ -------------------------------
Kathryn E. Falberg
Senior Vice President, Finance
and Chief Financial Officer
Date: 4/27/00 By:/s/Marc M.P. de Garidel
- ------------------ -------------------------------
Marc M.P. de Garidel
Vice President, Controller and
Chief Accounting Officer
22
AMGEN INC.
INDEX TO EXHIBITS
Exhibit No. Description
3.1 Restated Certificate of Incorporation as amended. (17)
3.2 Amended and Restated Bylaws. (25)
3.3 Certificate of Amendment of Restated Certificate of Incorporation.
(25)
3.4 Certificate of Amendment of Certificate of Designations of Series A
Junior Participating Preferred Stock. (25)
4.1 Indenture dated January 1, 1992 between the Company and Citibank
N.A., as trustee. (8)
4.2 First Supplement to Indenture, dated February 26, 1997 between the
Company and Citibank N.A., as trustee. (14)
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." (16)
4.4 8-1/8% Debentures due April 1, 2097. (16)
4.5 Form of stock certificate for the common stock, par value $.0001 of
the Company. (17)
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". (19)
4.7 6.50% Notes Due December 1, 2007 described in Exhibit 4.6. (19)
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. (22)
10.1 Company's Amended and Restated 1991 Equity Incentive Plan. (25)
10.2 Sixth Amendment to the Company's Amended and Restated Retirement and
Savings Plan as amended and restated April 1, 1996. (24)
10.3 Shareholder's Agreement of Kirin-Amgen, Inc., dated May 11, 1984,
between the Company and Kirin Brewery Company, Limited (with certain
confidential information deleted therefrom). (1)
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 (with certain confidential
information deleted therefrom). (3)
10.5 Product License Agreement, dated September 30, 1985, and Technology
License Agreement, dated, September 30, 1985 between the Company and
Ortho Pharmaceutical Corporation
23
(with certain confidential information deleted therefrom). (2)
10.6 Product License Agreement, dated September 30, 1985, and Technology
License Agreement, dated September 30, 1985 between Kirin-Amgen,
Inc. and Ortho Pharmaceutical Corporation (with certain confidential
information deleted therefrom). (3)
10.7 Company's Amended and Restated Employee Stock Purchase Plan. (12)
10.8 Research, Development Technology Disclosure and License Agreement
PPO, dated January 20, 1986, by and between the Company and Kirin
Brewery Co., Ltd. (4)
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 (with certain confidential information deleted therefrom). (5)
10.10 Assignment and License Agreement, dated October 16, 1986, between
the Company and Kirin-Amgen, Inc. (with certain confidential
information deleted therefrom). (5)
10.11 G-CSF European License Agreement, dated December 30, 1986, between
Kirin-Amgen, Inc. and the Company (with certain confidential
information deleted therefrom). (5)
10.12 Research and Development Technology Disclosure and License
Agreement: GM-CSF, dated March 31, 1987, between Kirin Brewery
Company, Limited and the Company (with certain confidential
information deleted therefrom). (5)
10.13 Company's Amended and Restated 1988 Stock Option Plan. (12)
10.14 Company's Amended and Restated Retirement and Savings Plan. (12)
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. (6)
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).
(7)
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. (9)
10.18 Amgen Inc. Supplemental Retirement Plan (As Amended and Restated
Effective November 1, 1999). (26)
10.19 Promissory Note of Mr. Kevin W. Sharer, dated June 4, 1993. (10)
10.20 Amended and Restated Amgen Performance Based Management Incentive
Plan. (25)
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. (23)
10.22 Promissory Note of Mr. George A. Vandeman, dated December 15, 1995.
(11)
24
10.23 Promissory Note of Mr. George A. Vandeman, dated December 15, 1995.
(11)
10.24 Agreement between Amgen Inc. and Dr. N. Kirby Alton, dated October
11, 1999. (26)
10.25 Amendment No. 1 to the Company's Amended and Restated Retirement and
Savings Plan. (12)
10.26 Seventh Amendment to the Amgen Retirement and Savings Plan as
Amended and Restated effective April 1, 1996. (25)
10.27 Amendment Number 2 to the Company's Amended and Restated Retirement
and Savings Plan dated April 1, 1996. (15)
10.28 Amgen Inc. Change of Control Severance Plan effective as of October
20, 1998. (24)
10.29 Preferred Share Rights Agreement, dated February 18, 1997, between
Amgen Inc. and American Stock Transfer and Trust Company, Rights
Agent. (13)
10.30 First Amendment, effective January 1, 1998, to the Company's Amended
and Restated Employee Stock Purchase Plan. (18)
10.31 Third Amendment, effective January 1, 1997, to the Company's Amended
and Restated Retirement and Savings Plan dated April 1, 1996. (18)
10.32 Agreement between Amgen Inc. and Dr. Fabrizio Bonanni, dated March
3, 1999. (26)
10.33 Promissory Note of Ms. Kathryn E. Falberg, dated April 7, 1995. (20)
10.34 Promissory Note of Mr. Edward F. Garnett, dated July 18, 1997. (20)
10.35 Fourth Amendment to the Company's Amended and Restated Retirement
and Savings Plan as amended and restated effective April 1, 1996.
(20)
10.36 Fifth Amendment to the Company's Amended and Restated Retirement and
Savings Plan as amended and restated effective April 1, 1996. (20)
10.37 Company's Amended and Restated 1987 Directors' Stock Option Plan.
(15)
10.38 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). (22)
10.39 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). (21)
10.40 Promissory Note of Dr. Fabrizio Bonanni, dated August 7, 1999. (26)
10.41 Promissory Note of Dr. Fabrizio Bonanni, dated October 29, 1999.
(26)
10.42* Agreement between Amgen Inc. and Dr. Lawrence M. Souza, Ph.D., dated
March 6, 2000.
27* Financial Data Schedule.
99* Sections appearing under the heading "Item 1. Business - Factors
That May Affect Amgen" in the Company's Annual Report on Form 10-K
for the year ended December 31, 1999.
- ----------------
25
* Filed herewith.
(1) Filed as an exhibit to the Annual Report on Form 10-K for the year ended
March 31, 1984 on June 26, 1984 and incorporated herein by reference.
(2) Filed as an exhibit to Quarterly Report on Form 10-Q for the quarter ended
September 30, 1985 on November 14, 1985 and incorporated herein by
reference.
(3) Filed as an exhibit to Quarterly Report on Form 10-Q for the quarter ended
December 31, 1985 on February 3, 1986 and incorporated herein by reference.
(4) 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.
(5) Filed as an exhibit to the Form 10-K Annual Report for the year ended March
31, 1987 on May 18, 1987 and incorporated herein by reference.
(6) 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.
(7) 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.
(8) Filed as an exhibit to Form S-3 Registration Statement dated December 19,
1991 and incorporated herein by reference.
(9) Filed as an exhibit to the Form 8-A dated March 31, 1993 and incorporated
herein by reference.
(10) Filed as an exhibit to the Form 10-Q for the quarter ended September 30,
1993 on November 12, 1993 and incorporated herein by reference.
(11) Filed as an exhibit to the Annual Report on Form 10-K for the year ended
December 31, 1995 on March 29, 1996 and incorporated herein by reference.
(12) 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.
(13) Filed as an exhibit to the Form 8-K Current Report dated February 18, 1997
on February 28, 1997 and incorporated herein by reference.
(14) Filed as an exhibit to the Form 8-K Current Report dated March 14, 1997 on
March 14, 1997 and incorporated herein by reference.
(15) 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.
(16) Filed as an exhibit to the Form 8-K Current Report dated April 8, 1997 on
April 8, 1997 and incorporated herein by reference.
(17) 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.
(18) 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.
(19) Filed as an exhibit to the Form 8-K Current Report dated and filed on
December 5, 1997 and incorporated herein by reference.
26
(20) Filed as an exhibit to the Annual Report on Form 10-K for the year ended
December 31, 1997 on March 24, 1998 and incorporated herein by reference.
(21) 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.
(22) 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.
(23) 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.
(24) 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.
(25) 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.
(26) 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.
27