Amgen (NASDAQ:AMGN), Thousand Oaks, Calif., reported adjusted
earnings per share (EPS), excluding stock option expense and certain
other expenses, of $1.08 for the first quarter of 2007, an increase of
19 percent compared to $0.91 during the first quarter of 2006. Adjusted
net income, excluding stock option expense and certain other expenses,
increased 15 percent to $1,270 million in the first quarter of 2007
compared to $1,101 million in the first quarter of 2006. Stock option
expense on a per share basis totaled 3 cents and 4 cents in the first
quarter of 2007 and 2006, respectively.
Total revenue increased 15 percent during the first quarter of 2007
to $3,687 million versus $3,217 million in the first quarter of 2006.
Adjusted EPS and adjusted net income for the first quarter 2007 and 2006
exclude stock option expense, certain expenses related to acquisitions
and certain other items. These expenses and other items are itemized on
the reconciliation tables below. Adjusted EPS including the impact of
stock option expense is also itemized on the reconciliation tables
below. On a reported basis and calculated in accordance with U.S.
Generally Accepted Accounting Principles (GAAP), Amgen's EPS was
$0.94 in the first quarter of 2007, an increase of 15 percent compared
to $0.82 in the same quarter of last year. Net income increased 11
percent to $1,111 million in the first quarter of 2007 versus $1,001
million in the first quarter of 2006. In the first quarter of 2007,
reported GAAP results were negatively impacted by the write-off of
deferred financing and related costs of $51 million resulting from the
repayment of $1.7 billion of convertible debt. "Our key products
delivered good sales growth during the quarter," said Kevin Sharer,
chairman & CEO. "We are confident ESAs, including Aranesp and
EPOGEN, maintain a favorable benefit/risk profile when used in
accordance with label recommendations. We project adjusted EPS will be
at the low end of our earnings guidance range, and we will update our
revenue guidance as the year progresses," concluded Sharer.
Product Sales Performance
During the first quarter, total product sales increased 14 percent
to $3,565 million from $3,127 million in the first quarter of 2006.
Sales in the United States totaled $2,884 million, an increase of 12
percent versus $2,571 million in the first quarter of 2006.
International sales increased 22 percent to $681 million versus $556
million for the first quarter of 2006. Changes in foreign exchange
positively impacted first quarter 2007 international sales by $42
million. Excluding the impact of foreign exchange, total product sales
increased 13 percent and international product sales increased 15
percent.
Worldwide sales of Aranesp (darbepoetin alfa) increased 14 percent
to $1,020 million in the first quarter of 2007 versus $893 million
during the first quarter of 2006. This growth was principally driven by
demand. U.S. Aranesp sales were $654 million versus $596 million in the
first quarter of the prior year, an increase of 10 percent, reflecting
both an increase in demand due to segment growth and to a lesser degree
favorable wholesaler inventory changes. The slowing growth rate in the
United States was driven by initial customer reaction to label changes.
International Aranesp sales increased 23 percent to $366 million versus
$297 million in the first quarter of 2006, reflecting increased demand
due to segment growth and share gains, as well as changes in foreign
exchange which positively impacted first quarter 2007 sales by
approximately $24 million. Excluding the impact of foreign exchange,
worldwide product sales increased 12 percent and international sales
increased 15 percent. Sales of EPOGEN[R] (Epoetin alfa) increased 3
percent to $625 million in the first quarter of 2007 versus $604 million
in the first quarter of 2006. Growth was driven by favorable revised
estimates of dialysis demand (primarily spillover) for prior quarters
and favorable wholesaler inventory changes, partially offset by changes
in customer purchasing patterns versus the first quarter of the prior
year. Spillover is a result of the company's contractual
relationship with Johnson & Johnson.
Combined worldwide sales of Neulasta (pegfilgrastim) and NEUPOGEN
(Filgrastim), increased 14 percent to $1,018 million in the first
quarter of 2007 versus $896 million for the first quarter of 2006,
driven by increased demand for Neulasta. Combined sales of Neulasta and
NEUPOGEN in the United States were $777 million in the first quarter of
2007 versus $688 million in the first quarter of 2006, an increase of 13
percent reflecting both an increase in demand for Neulasta due to
segment growth and to a lesser degree favorable wholesaler inventory
changes. Neulasta segment growth is attributable to an increase in
patients in part due to the continued increase of Neulasta first-cycle
use, as well as higher net sales price.
Combined international sales increased 16 percent to $241 million
in the first quarter of 2007 versus $208 million for the same quarter in
the prior year, reflecting both the continued conversion to Neulasta and
changes in foreign exchange which positively impacted first quarter 2007
combined international sales by approximately $16 million. Excluding the
impact of foreign exchange, combined worldwide sales increased 12
percent and international product sales increased 8 percent. Sales of
Enbrel (etanercept) increased 11 percent in the first quarter to $730
million versus $658 million during the same period in 2006 reflecting an
increase in demand due to increases in both patients and net sales
price. Sales growth continued in both rheumatology and dermatology, and
ENBREL continues to maintain a leading position in both segments.
However, ENBREL sales growth in the first quarter was affected by slight
share declines in the United States in both segments versus the first
quarter of 2006 due to increased competitive activity.
Worldwide sales of Sensipar first quarter of 2007 versus $61
million during the first quarter of 2006. This growth was principally
driven by demand. VectibixTM (panitumumab) sales for the first quarter
were $51 million as compared to $39 million in the fourth quarter of
2006. Operating Expense Analysis on an Adjusted Basis: Cost of sales
increased 1 percent to $559 million in the first quarter of 2007 versus
$552 million in the first quarter of 2006. Increased sales volumes were
largely offset by manufacturing efficiencies. R&D expenses increased
29 percent to $803 million in the first quarter of 2007 versus $624
million in the first quarter of 2006. The first quarter increase was
primarily to support the increased number and expense of mega-trials to
advance our late-stage pipeline as well as the continued advancement of
earlier stage compounds.
Selling, general and administrative (SG&A) expenses increased
15 percent to $748 million in the first quarter of 2007 versus $652
million in the first quarter of 2006. The increase reflects higher Wyeth
profit share expenses related to strong ENBREL sales and continuing
investment in infrastructure including our global ERP program.
During the first quarter of 2007, adjusted EPS growth of 19 percent
exceeded revenue growth of 15 percent by 4 percentage points. EPS
leverage for the first quarter was principally driven by fewer shares
used in the computation of adjusted diluted EPS and a lower adjusted tax
rate partially offset by lower adjusted interest income and
significantly higher adjusted R&D investment. The adjusted tax rate
was lower due to increased R&D tax credits coupled with greater
offshore manufacturing in Puerto Rico. During the first quarter of 2007,
Amgen repurchased 8.8 million shares of its common stock at a total cost
of $537 million. In December 2006, Amgen's Board of Directors
authorized a new stock repurchase program of $5.0 billion. The company
currently has $6.0 billion remaining under this and the previously
authorized stock repurchase program. Average diluted shares for adjusted
EPS in the first quarter of 2007 were 1,172 million versus 1,214 million
in the first quarter of 2006.
Capital expenditures for the first quarter of 2007 were
approximately $325 million versus $225 million in the first quarter of
2006. Capital expenditures in 2007 are expected to be similar to the
prior year. Worldwide cash and marketable securities were $4.8 billion
and debt was $7.3 billion at the end of the first quarter of 2007.
Revenue guidance is up for review at this time; the company will be
taking actions to reduce operating expenses in order to offset revenue
impact. Adjusted EPS is expected to be at low end of the previously
stated range of $4.30 - $4.50.
First Quarter Product and Pipeline Update
The company provided updates on selected late-stage clinical
programs (Aranesp, AMG 531 and denosumab) and highlights of what it will
cover at the upcoming American Society of Clinical Oncology (ASCO)
meeting in June.
Aranesp:
The company provided updates on recent meetings of the Independent
Data Monitoring Committees for both TREAT (Trial to Reduce
cardiovascular Events with Aranesp Therapy), which examines outcomes in
anemic patients with renal insufficiency, and the RED-HF (Reduction of
Events with Darbepoetin alfa in Heart Failure) TrialTM, which examines
the utility of Aranesp for the treatment of heart failure. Based on
their reviews, the committees recommended that both studies continue as
planned without modification.
AMG 531: Data from the recently completed Phase 3 study of AMG 531
in pre-splenectomy immune thrombocytopenic purpura (ITP) patients have
become available. Review of the data from this study revealed a
favorable efficacy and safety profile, with all endpoints successfully
met. Based on the positive results from this study, along with the
positive results from its other Phase 3 study of patients with ITP
despite prior splenectomy, the company is on track to file in 2007 for
approval of AMG 531 in the ITP indication in both the United States and
Europe. The company has previously received fast track designation from
the Food and Drug Administration (FDA) in this indication. Denosumab:
Data from the 332-patient Phase 3 study in Postmenopausal Osteoporosis
(PMO) have become available to the company. Based on the company's
review of the data, all primary and secondary endpoints were
successfully met. The company expects to see data later this year from
an ongoing Phase 2 study of PMO Treatment and a Phase 3 study in breast
cancer patients undergoing hormone ablation therapy.
ASCO Update: The company expects data results from several of their
programs to be presented at the upcoming annual ASCO meeting in June.
Among the presentations will be details from Phase 1 studies involving a
number of the company's earlier stage oncology programs including
AMG 102, AMG 386, AMG 479, AMG 655 and APO2L/TRAIL, (a molecule being
developed in collaboration with Genentech, Inc.). Additionally, results
from certain of the company's later stage programs will be
presented, including a Phase 2 study of AMG 531 in thrombocytopenic
patients with Myelodysplastic Syndrome and the Phase 2 study of
motesanib diphosphate in patients with locally advanced or metastatic
thyroid cancer.
For more product information or the full prescribing information,
refer to the Amgen Web site at http://www.amgen.com.
About Amgen
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science's promise by bringing
safe and effective medicines from lab, to manufacturing plant, to
patient. Amgen therapeutics have changed the practice of medicine,
helping millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis and other serious illnesses. With a
deep and broad pipeline of potential new medicines, Amgen remains
committed to advancing science to dramatically improve people's
lives.
For more information, visit http://www.amgen.com or call
805/447-4613.
COPYRIGHT 2007 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2007, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.