THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 19, 2005--Amgen Inc. (NASDAQ:AMGN):
Amgen (NASDAQ:AMGN) reported adjusted earnings per share (EPS) for the second quarter of 2005 of 88 cents, an increase of 42 percent compared to 62 cents during the second quarter of 2004. Adjusted net income rose 36 percent to $1.1 billion compared to $809 million in the second quarter of 2004. The company also increased its full year guidance for total revenue growth to a range of mid-to-high teens from the previous range of low double-digits to mid-teens and for adjusted EPS to a range of $3.10 to $3.20 from the previous range of $2.80 to $2.90, which represents an increase of 29 to 33 percent over 2004 adjusted EPS.
During the second quarter, total product sales increased 26 percent to $3.1 billion from $2.4 billion in the second quarter of 2004. Second quarter U.S. sales totaled $2.5 billion, an increase of 26 percent versus the same quarter in 2004. International sales totaled $540 million versus $424 million during the comparable period in 2004, an increase of 27 percent. International sales benefited from foreign exchange by approximately $31 million. Total revenue increased 23 percent during the second quarter to $3.2 billion.
Adjusted earnings per share and adjusted net income for the three months ended June 30, 2005 and 2004 primarily exclude certain expenses related to the acquisitions of Immunex Corporation and Tularik Inc. These expenses and other items are itemized on the reconciliation tables below.
On a reported basis and calculated in accordance with U.S. generally accepted accounting principles (GAAP), Amgen's earnings per share increased 44 percent to 82 cents in the second quarter of 2005 from 57 cents in the same quarter last year. Net income was $1.0 billion in the second quarter of 2005 versus $748 million for the second quarter of 2004, an increase of 38 percent.
"Our strong business momentum continued well into the second quarter, which has enabled us to raise revenue and earnings guidance for the year," said Kevin Sharer, chairman and CEO. "Our pipeline continues to advance, which will be key to driving long-term growth," concluded Sharer.
Product Sales Performance
Worldwide sales of Aranesp® (darbepoetin alfa), increased 36 percent to $837 million in the second quarter of 2005 versus $617 million during the second quarter of 2004. This growth was driven principally by demand reflecting market share gains and to a lesser extent market growth. U.S. Aranesp sales were $536 million versus $380 million in the prior year, with share gains in all major segments driving growth. International Aranesp sales were $301 million versus $237 million in the same quarter last year. International Aranesp sales benefited from foreign exchange of approximately $17 million in the second quarter.
Sales of EPOGEN® (Epoetin alfa) during the second quarter were $647 million versus $633 million in the comparable period of 2004. EPOGEN sales increased by two percent in the second quarter of 2005 reflecting a decrease in demand that was offset by wholesaler inventory changes and a favorable revised estimate of dialysis demand (primarily spillover) for prior quarters. Demand was affected by higher sales incentives and increased usage of Aranesp in dialysis. Spillover is a result of the company's contractual relationship with Johnson & Johnson. (Please refer to the Company's 2004 Form 10-K for a more detailed discussion of this relationship and a description of spillover.)
Combined worldwide sales of Neulasta® (pegfilgrastim) and NEUPOGEN® (filgrastim), were $899 million in the second quarter of 2005 versus $721 million for the second quarter of 2004, an increase of 25 percent. Combined sales growth for Neulasta and NEUPOGEN was primarily driven by increased demand for Neulasta.
Combined sales of Neulasta and NEUPOGEN in the United States were $698 million in the second quarter of 2005 versus $557 million in the second quarter of 2004, an increase of 25 percent. Combined international sales increased 23 percent to $201 million in the second quarter of 2005 versus $164 million over the same quarter in the prior year. Combined international Neulasta and NEUPOGEN sales benefited from foreign exchange by approximately $11 million in the second quarter of 2005.
Sales of Enbrel® (etanercept), increased 45 percent during the second quarter to $639 million versus $440 million during the same period in 2004, driven by strong demand. ENBREL continues to lead the Dermatology biologic marketplace and its market share is stable in the competitive Rheumatology setting.
Operating Expense Analysis on an Adjusted Basis:
Cost of sales increased to $530 million in the second quarter of 2005 from $435 million during the second quarter of 2004, primarily due to higher sales volumes.
Research and development (R&D) expenses totaled $564 million during the second quarter versus $460 million in the second quarter of 2004. Second quarter increases were primarily driven by staff-related expenses in part related to the Tularik acquisition and key clinical trials including the ramp up of large-scale Phase 3 trials for AMG 162, Amgen's investigational therapy for bone loss.
Selling, general and administrative (SG&A) expenses were $646 million in the second quarter versus $587 million for the same quarter of the prior year. Increases for the second quarter are a result of higher staff-related expenses in support of the Company's key products and the Wyeth profit share related to ENBREL sales growth.
Amgen's adjusted tax rate decreased five percentage points compared to the second quarter of 2004 due to favorable resolution of prior year tax claims with the IRS and to a lesser degree, an increase in permanently reinvested earnings of its foreign subsidiaries. The favorable resolution of prior year tax claims benefited adjusted EPS by approximately 4 cents during the quarter. For the remainder of the year, the adjusted tax rate is expected to be slightly lower than the Company's first quarter 2005 adjusted rate of 26.4 percent.
Stock repurchases for the second quarter 2005 totaled $750 million representing approximately 12 million shares. In December 2004, the Company's board of directors authorized a stock repurchase program of $5 billion. At the end of the second quarter, the Company had $3.5 billion remaining under this stock authorization.
Capital expenditures for the second quarter of 2005 were $205 million, primarily due to construction at the company's Puerto Rico manufacturing facility, versus $356 million in 2004. The company's cash and marketable securities were $4.4 billion at the end of the quarter.
Second Quarter Product and Pipeline Highlights
AMG 162: During the second quarter, pivotal Phase 3 trials for AMG 162 completed enrollment in postmenopausal osteoporosis and treatment induced bone loss in non-metastatic breast cancer and prostate cancer.
Aranesp: Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Aranesp. The sBLA is based on Phase 3 data that Amgen believes will demonstrate Aranesp administered every three weeks is safe and effective in the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
New interim data for Aranesp suggesting a major response in anemic patients with myelodysplastic syndromes (MDS) was recently presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) at Geneva. The data was generated from a Phase 2 study evaluating the use of 500 mcg of Aranesp every three weeks to treat anemia in patients with MDS.
Enbrel: During the quarter, the FDA approved an expanded indication for ENBREL to improve physical function in patients with psoriatic arthritis. ENBREL is the first and only treatment to receive this expanded indication.
Panitumumab: Amgen, together with its partner Abgenix, announced the initiation of a Phase 3 clinical study to evaluate the potential benefits of adding panitumumab, an experimental fully human antibody to bevacizumab (Avastin) and chemotherapy. The clinical trial called the PACCE (Panitumumab Advanced Colorectal Cancer Evaluation) study is a randomized, multi-center, open label study with endpoints of progression-free survival, overall survival and response rate.
AMG 531: Amgen is in the process of filing an IND in chemotherapy-induced thrombocytopenia (CIT) for AMG 531. Studies in CIT will begin in 2005.
For more product information or the full prescribing information, please refer to the Amgen Web site at www.amgen.com.
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2004, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by first party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.
About Amgen
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
Amgen Inc.
Condensed Consolidated Statements of Operations and
Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
Three Months Ended
June 30, 2005
------------------------------
GAAP Adjustments "Adjusted"
------------------------------
Revenues:
Product sales $3,072 $- $3,072
Other revenues 100 - 100
------- ----------- ----------
Total revenues 3,172 - 3,172
Operating expenses:
Cost of sales (excludes amortization
of acquired intangible assets
presented below) 530 - 530
Research and development 567 (3)(1) 564
Selling, general and administrative 646 - 646
Amortization of intangible assets 87 (87)(2) -
Legal settlements 49 (49)(3) -
------- ----------- ----------
Total operating expenses 1,879 (139) 1,740
Operating income 1,293 139 1,432
Interest and other (expense)/income,
net 6 (20)(4) (14)
------- ----------- ----------
Income before income taxes 1,299 119 1,418
Provision for income taxes 270 44 (7) 314
------- ----------- ----------
Net income $1,029 $75 $1,104
======= =========== ==========
Earnings per share:
Basic $0.83 $0.90
Diluted (8) $0.82 $0.88
Shares used in calculation of
earnings per share:
Basic 1,233 1,233
Diluted (8) 1,250 1,250
(1) - (8) See explanatory notes
Three Months Ended
June 30, 2004
-------------------------------
GAAP Adjustments "Adjusted"
-------------------------------
Revenues:
Product sales $2,431 $- $2,431
Other revenues 154 - 154
------- ----------- ----------
Total revenues 2,585 - 2,585
Operating expenses:
Cost of sales (excludes amortization
of acquired intangible assets
presented below) 435 - 435
Research and development 468 (8)(5) 460
Selling, general and
administrative 591 (4)(5) 587
Amortization of intangible assets 84 (84)(2) -
Legal settlements - - -
------- ----------- ----------
Total operating expenses 1,578 (96) 1,482
Operating income 1,007 96 1,103
Interest and other
(expense)/income, net 10 - 10
------- ----------- ----------
Income before income taxes 1,017 96 1,113
Provision for income taxes 269 35 (7) 304
------- ----------- ----------
Net income $748 $61 $809
======= =========== ==========
Earnings per share:
Basic $0.59 $0.64
Diluted (8) $0.57 $0.62
Shares used in calculation of
earnings per share:
Basic 1,268 1,268
Diluted (8) 1,318 1,318
(1) - (8) See explanatory notes
Amgen Inc.
Condensed Consolidated Statements of Operations and
Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
Six Months Ended
June 30, 2005
------------------------------
GAAP Adjustments "Adjusted"
------------------------------
Revenues:
Product sales $5,807 $- $5,807
Other revenues 198 - 198
------- ----------- ----------
Total revenues 6,005 - 6,005
Operating expenses:
Cost of sales (excludes amortization
of acquired intangible assets
presented below) 1,019 - 1,019
Research and development 1,091 (6)(1) 1,085
Selling, general and administrative 1,223 - 1,223
Amortization of intangible assets 174 (174)(2) -
Legal settlements 49 (49)(3) -
------- ----------- ----------
Total operating expenses 3,556 (229) 3,327
Operating income 2,449 229 2,678
Interest and other (expense)/income,
net (4) (20)(4) (4)
20 (6)
------- ----------- ----------
Income before income taxes 2,445 229 2,674
Provision for income taxes 562 84 (7) 646
------- ----------- ----------
Net income $1,883 $145 $2,028
======= =========== ==========
Earnings per share:
Basic $1.52 $1.63
Diluted (8) $1.49 $1.60
Shares used in calculation of
earnings per share:
Basic 1,241 1,241
Diluted (8) 1,270 1,270
(1) - (8) See explanatory notes
Six Months Ended
June 30, 2004
------------------------------
GAAP Adjustments "Adjusted"
------------------------------
Revenues:
Product sales $4,639 $- $4,639
Other revenues 289 - 289
------- ----------- ----------
Total revenues 4,928 - 4,928
Operating expenses:
Cost of sales (excludes amortization
of acquired intangible assets
presented below) 809 (2)(5) 807
Research and development 909 (16)(5) 893
Selling, general and administrative 1,107 (8)(5) 1,099
Amortization of intangible assets 168 (168)(2) -
Legal settlements - - -
------- ----------- ----------
Total operating expenses 2,993 (194) 2,799
Operating income 1,935 194 2,129
Interest and other (expense)/income, net 31 - 31
------- ----------- ----------
Income before income taxes 1,966 194 2,160
Provision for income taxes 528 71 (7) 599
------- ----------- ----------
Net income $1,438 $123 $1,561
======= =========== ==========
Earnings per share:
Basic $1.13 $1.22
Diluted (8) $1.09 $1.19
Shares used in calculation of
earnings per share:
Basic 1,274 1,274
Diluted (8) 1,326 1,326
(1) - (8) See explanatory notes
Amgen Inc.
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings
(In millions, except per share data)
(Unaudited)
(1) To exclude the incremental compensation provided to certain
Tularik Inc. ("Tularik") employees principally related to non-cash
compensation expense associated with stock options assumed in
connection with the acquisition and amounts payable under the
Tularik short-term retention plan. The total estimated remaining
costs of such incremental compensation is approximately $21
million, pre-tax.
(2) To exclude the ongoing, non-cash amortization of acquired
intangible assets, primarily Enbrel®, related to the Immunex
Corporation ("Immunex") acquisition. The total 2005 annual
non-cash charge is currently estimated to be approximately $347
million, pre-tax.
(3) To exclude the impact of legal settlements incurred, net of
amounts previously accrued, primarily related to settling a patent
legal proceeding.
(4) To exclude the net gain realized on the termination of a
manufacturing agreement with Genentech, Inc. ("Genentech") for the
production of ENBREL at Genentech's manufacturing facility in
South San Francisco.
(5) To exclude the incremental compensation payable to certain Immunex
employees principally under the Immunex short-term retention plan.
All amounts have been incurred under this plan.
(6) To exclude the pro rata portion of the debt issuance costs that
were immediately charged to interest expense, as a result of
certain holders of the convertible notes exercising their March 1,
2005 put option and the related convertible notes being repaid in
cash.
(7) To reflect the tax effect of the above adjustments.
(8) The following table presents the computations for GAAP and
"Adjusted" diluted earnings per share computed under the treasury
stock and the "if-converted" methods:
Three Months Ended Three Months Ended
June 30, 2005 June 30, 2004
------------------- ------------------
GAAP "Adjusted" GAAP "Adjusted"
------------------- ------------------
Income (Numerator):
Net income for basic EPS $1,029 $1,104 $748 $809
Adjustment for interest
expense on convertible
notes, net of tax (A) 1 1 5 5
------- ---------- ------- ----------
Net income for diluted
EPS, after assumed
conversion of
convertible notes $1,030 $1,105 $753 $814
======= ========== ======= ==========
Shares (Denominator):
Weighted-average shares
for basic EPS 1,233 1,233 1,268 1,268
Effect of dilutive
securities 9 9 15 15
Effect of convertible
notes, after assumed
conversion (A) 8 8 35 35
------- ---------- ------- ----------
Weighted-average shares
for diluted EPS 1,250 1,250 1,318 1,318
======= ========== ======= ==========
Diluted earnings per share $0.82 $0.88 $0.57 $0.62
======= ========== ======= ==========
Six Months Ended Six Months Ended
June 30, 2005 June 30, 2004
------------------ ------------------
GAAP "Adjusted" GAAP "Adjusted"
------------------ ------------------
Income (Numerator):
Net income for basic EPS $1,883 $2,028 $1,438 $1,561
Adjustment for interest
expense on convertible
notes, net of tax (A) 6 6 11 11
------- ---------- ------- ----------
Net Income for diluted
EPS, after assumed
conversion of
convertible notes $1,889 $2,034 $1,449 $1,572
======= ========== ======= ==========
Shares (Denominator):
Weighted-average shares
for basic EPS 1,241 1,241 1,274 1,274
Effect of dilutive
securities 10 10 17 17
Effect of convertible
notes, after assumed
conversion (A) 19 19 35 35
------- ---------- ------- ----------
Adjusted weighted-average
shares for diluted EPS 1,270 1,270 1,326 1,326
======= ========== ======= ==========
Diluted earnings per share $1.49 $1.60 $1.09 $1.19
======= ========== ======= ==========
(A) On May 6, 2005, in connection with an exchange offer, we modified
the terms of approximately 95% of our convertible notes then
outstanding (the "Modified Convertible Notes"). As a result of
certain of these modifications, if converted, the Modified
Convertible Notes would be settled in 1) cash equal to the lesser
of the accreted value of the Modified Convertible Notes at the
conversion date or the conversion value, as defined, and 2) shares
of common stock, if any, to the extent the conversion value
exceeds the accreted value. Accordingly, the Modified Convertible
Notes do not impact diluted earnings per share under the
"if-converted" method but rather, they impact diluted earnings per
share under the treasury stock method, and only to the extent that
the conversion value exceeds the accreted value during any
reporting period, requiring such difference, if any, to be
potentially settled in shares of common stock.
Amgen Inc.
Product Sales Detail by Product and Geographic Region
(In millions)
(Unaudited)
Three Months Six Months
Ended Ended
June 30, June 30,
--------------- ---------------
2005 2004 2005 2004
--------------- ---------------
Aranesp® - U.S. $536 $380 $983 $710
Aranesp® - International 301 237 577 450
EPOGEN® - U.S. 647 633 1,230 1,223
Neulasta® - U.S. 490 362 906 698
Neulasta® - International 97 64 182 123
NEUPOGEN® - U.S. 208 195 390 367
NEUPOGEN® - International 104 100 216 197
Enbrel® - U.S. 614 423 1,184 805
Enbrel® - International 25 17 47 32
Other product sales - U.S. 37 14 70 22
Other product sales - International 13 6 22 12
--------------- ---------------
Total product sales $3,072 $2,431 $5,807 $4,639
=============== ===============
U.S. $2,532 $2,007 $4,763 $3,825
International 540 424 1,044 814
--------------- ---------------
$3,072 $2,431 $5,807 $4,639
=============== ===============
Amgen Inc.
Condensed Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
June 30, Dec. 31,
2005 2004
------------ ----------
Assets
Current assets:
Cash and marketable securities $4,440 $5,808
Trade receivables, net 1,707 1,461
Inventories 984 888
Other current assets 894 1,013
------------ ----------
Total current assets 8,025 9,170
Property, plant, and equipment, net 4,863 4,712
Intangible assets, net 3,872 4,033
Goodwill 10,519 10,525
Other assets 759 781
------------ ----------
Total assets $28,038 $29,221
============ ==========
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $3,178 $2,984
Convertible notes 1,749(2) 1,173(1)
------------ ----------
Total current liabilities 4,927 4,157
Deferred tax liabilities 1,209 1,294
Convertible notes - 1,739(2)
Other long-term debt 2,198 2,198
Other non-current liabilities 123 128
Stockholders' equity 19,581 19,705
------------ ----------
Total liabilities and stockholders'
equity $28,038 $29,221
============ ==========
Shares outstanding 1,231 1,260
(1) On March 2, 2005, as a result of certain holders of the
Convertible notes exercising their March 1, 2005 put option, the
Company repurchased $1,175 million, or approximately 40%, of the
outstanding Convertible notes at their then-accreted value for
cash. Accordingly the Convertible notes repurchased were
classified as current liabilities at December 31, 2004.
(2) Holders of the remaining outstanding Convertible notes may require
the Company to purchase all or a portion of the notes on specific
dates as early as March 1, 2006 at the original issuance price
plus accrued original issue discount through the purchase date.
Accordingly, as of June 30, 2005, the Convertible notes have been
classified as current liabilities.
Amgen Inc.
Reconciliation of "Adjusted" Earnings Per Share Guidance to GAAP
Earnings Per Share Guidance for the Year Ended December 31, 2005
2005
--------------
"Adjusted" earnings per share guidance $3.10 - $3.20
Known adjustments to arrive at GAAP earnings:
Amortization of acquired intangible assets (1) (0.16)
Tularik merger related incremental compensation (2) (0.01)
Write-off of convertible notes debt issuance costs (3) (0.01)
Legal settlements (4) (0.02)
Termination of manufacturing agreement (5) 0.01
Tax liability related to repatriation of certain
foreign earnings (6) -
--------------
GAAP earnings per share guidance $2.91 - $3.01
--------------
The guidance for both "Adjusted" earnings per share and GAAP
earnings per share does not include the impact of expense related
to stock option compensation.
(1) To exclude the ongoing, non-cash amortization of acquired
intangible assets, primarily Enbrel(R), related to the Immunex
acquisition. The total 2005 annual non-cash charge is currently
estimated to be approximately $347 million, pre-tax.
(2) To exclude the incremental compensation provided to certain
Tularik employees principally related to non-cash compensation
expense associated with stock options assumed in connection with
the acquisition and amounts payable under the Tularik short-term
retention plan.
(3) To exclude the pro rata portion of debt issuance costs that were
immediately charged to interest expense, as a result of certain
holders of the convertible notes exercising their March 1, 2005
put option and the related convertible notes being repaid in cash.
(4) To exclude the impact of legal settlements incurred, net of
amounts previously accrued, primarily related to settling a patent
legal proceeding.
(5) To exclude the net gain realized on the termination of a
manufacturing agreement with Genentech for the production of
ENBREL at Genentech's manufacturing facility in South San
Francisco.
(6) To exclude the tax liability related to the repatriation of
certain foreign earnings under the American Jobs Act of 2004
("Jobs Act"). Uncertainty remains as to how to interpret numerous
provisions of the Jobs Act. As such, we have not yet determined
the amount of foreign earnings, if any, that will be repatriated
and, therefore, the amount of the tax liability is not known.
Based on our preliminary analysis to date, we are limited under
the Jobs Act to repatriate up to approximately $500 million in
foreign earnings.
2004 adjusted earnings per share was $2.40 and a reconciliation to
GAAP earnings per share for this amount was provided in our
January 27, 2005 news release.
CONTACT: Amgen Inc., Thousand Oaks Mary Klem, 805-447-4587 (Media) Arvind Sood, 805-447-1060 (Investors) SOURCE: Amgen Inc.