24.10.2007 20:08:00
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Amgen's Third Quarter 2007 Adjusted Earnings Per Share Increased 4 Percent to $1.08
Amgen (NASDAQ:AMGN) reported adjusted earnings per share (EPS),
excluding stock option expense and certain other expenses, of $1.08 for
the third quarter of 2007, an increase of 4 percent compared to $1.04
for the third quarter of 2006. Adjusted net income, excluding stock
option expense and certain other expenses, decreased 4 percent to $1,181
million in the third quarter of 2007 compared to $1,224 million in the
third quarter of 2006. Stock option expense on a per share basis totaled
2 cents and 3 cents for the third quarter of 2007 and 2006,
respectively.
Total revenue remained unchanged during the third quarter of 2007 at
$3.6 billion versus the third quarter of 2006.
Adjusted EPS and adjusted net income for the third quarter 2007 and 2006
exclude stock option expense, certain expenses related to acquisitions,
restructuring charges and certain other items. These expenses and other
items are itemized on the attached reconciliation tables. Adjusted EPS
including the impact of stock option expense are also itemized on the
attached reconciliation tables.
On a reported basis and calculated in accordance with U.S. Generally
Accepted Accounting Principles (GAAP), Amgen’s
GAAP EPS were $0.18 and GAAP net income was $201 million for the third
quarter of 2007. These amounts are down from the prior year GAAP EPS of
$0.94 and GAAP net income of $1.1 billion. GAAP reported results for the
third quarter of 2007 were negatively impacted by the write-off of $590
million of acquired in-process research and development related to the
acquisitions of Alantos and Ilypsa; $293 million of charges principally
related to asset impairment, accelerated depreciation, staff separation
costs and accruals for losses on leased facilities in connection with
the previously announced restructuring plan; and the write-off of $90
million of inventory principally due to the changing regulatory and
reimbursement environments.
As a result of the regulatory and reimbursement changes to
Erythropoiesis Stimulating Agent (ESA) products and their impact on the
Company’s operations, in particular Aranesp®
(darbepoetin alfa), on Aug. 15, 2007, Amgen announced plans to
restructure worldwide operations in order to improve its cost structure
while continuing to make significant innovative research and development
investments and build the framework for future growth. In connection
with this restructuring plan, the Company expects to incur approximately
$775 million to $850 million in total restructuring charges (as compared
to the prior estimate of $600 million to $700 million). The increase in
the total estimated restructuring charges is primarily the result of
additional rationalization of manufacturing facilities, including the
indefinite postponement of planned manufacturing operations in Ireland
and the closure of a clinical manufacturing facility in Thousand Oaks.
Through Sept. 30, 2007, Amgen has incurred $582 million of restructuring
charges and anticipates that the remaining estimated charges will be
incurred in the fourth quarter of 2007 and, to a lesser degree, in 2008.
"Sales of our ESA products were adversely
affected by regulatory and reimbursement changes,”
said Kevin Sharer, chairman & CEO. "We
are making good progress in implementing a global restructuring plan to
rationalize our cost structure and improve cash flow, while continuing
to invest in the future.” Product Sales Performance
During the third quarter, total product sales increased 1 percent to
$3,524 million from $3,503 million in the third quarter of 2006. Sales
in the U.S. totaled $2,809 million, a decline of 2 percent versus $2,864
million in the third quarter of 2006. International sales increased 12
percent to $715 million versus $639 million in the third quarter of
2006. Changes in foreign exchange positively impacted third quarter 2007
international sales by $46 million. Excluding the impact of foreign
exchange, total product sales decreased 1 percent and international
product sales increased 5 percent.
Worldwide sales of Aranesp decreased 23 percent to $818 million in the
third quarter of 2007 versus $1,067 million in the third quarter of
2006. This was principally driven by a decline in U.S. demand. U.S.
Aranesp sales were $460 million versus $720 million in the third quarter
of the prior year, a decrease of 36 percent. This was due to a decline
in demand primarily reflecting reaction to regulatory and reimbursement
developments throughout the year, including the National Coverage
Determination (NCD) issued by the Center for Medicare & Medicaid
Services (CMS) on July 30. To a lesser extent, this also reflects a
decline in segment share versus the third quarter of the prior year.
International Aranesp sales increased 3 percent to $358 million versus
$347 million in the third quarter of 2006, due to changes in foreign
exchange which positively impacted third quarter 2007 sales by
approximately $24 million. In Europe, growth was negatively impacted by
dosing conservatism in the oncology segment and price pressure across
the ESA class. Excluding the impact of foreign exchange, worldwide
Aranesp sales decreased 26 percent and international sales decreased 4
percent.
Sales of EPOGEN®
(Epoetin alfa) decreased 5 percent to $602 million in the third quarter
of 2007 versus $633 million in the third quarter of 2006. This was
primarily driven by a decline in dose / utilization and increased
discounts versus the third quarter of the prior year, partially offset
by patient population growth of 3 percent. The decline in dose /
utilization reflects reaction to regulatory and reimbursement
developments throughout the year, including final KDOQI™
guidelines, revised labeling and the pending EMP update.
Combined worldwide sales of Neulasta®
(pegfilgrastim) and NEUPOGEN®
(Filgrastim), increased 10 percent to $1,100 million in the third
quarter of 2007 versus $998 million in the third quarter of 2006.
Combined sales of Neulasta and NEUPOGEN in the U.S. were $830 million in
the third quarter of 2007 versus $772 million in the third quarter of
2006, an increase of 8 percent primarily driven by favorable wholesaler
inventory changes. Combined international sales increased 19 percent to
$270 million in the third quarter of 2007 versus $226 million for the
same quarter in the prior year, reflecting both increased conversion to
Neulasta versus the third quarter of the prior year and changes in
foreign exchange which positively impacted third quarter 2007 combined
international sales by $18 million. Excluding the impact of foreign
exchange, combined worldwide sales increased 8 percent and international
product sales increased 12 percent.
Sales of Enbrel®
(etanercept) increased 16 percent in the third quarter of 2007 to $821
million versus $705 million during the same period in 2006 driven by an
increase in demand due to increases in both patients and net sales
price. Sales growth continued in both rheumatology and dermatology,
driven by segment growth that was partially offset by slight share
declines versus the third quarter of the prior year. ENBREL continues to
maintain a leading position in both segments.
Worldwide sales of Sensipar®
(cinacalcet HCl) increased 47 percent to $122 million in the third
quarter of 2007 versus $83 million in the third quarter of 2006. This
growth was principally driven by demand.
VectibixTM (panitumumab) sales for the third
quarter were $41 million as compared to $45 million in the second
quarter of 2007. This decrease was primarily driven by reaction to
unfavorable Panitumumab Advanced Colorectal Cancer Evaluation (PACCE)
study results released late in the first quarter of 2007.
Operating Expense Analysis on an Adjusted Basis: Cost of sales increased 21 percent to $585 million in the third
quarter of 2007 versus $485 million in the third quarter of 2006. This
increase was primarily driven by product mix, due to higher sales of
ENBREL, which is more costly to manufacture, as well as certain other
items. These include an excess capacity charge at the Company’s
manufacturing facility in Puerto Rico and the write-off of excess
inventory primarily related to certain new product presentations. Excess
capacity charges are expected to continue to occur through 2008. Cost of
sales margin throughout this period is expected to be similar to the
third quarter of 2007 due to excess capacity charges and product mix.
Research & Development (R&D) expenses decreased 16
percent to $699 million in the third quarter of 2007 versus $835 million
in the third quarter of 2006. R&D expenses were lower primarily due to
optimization of ongoing trials, lower in-licensing expenses primarily
due to two deals in the third quarter of 2006 and the benefit derived
from licensing denosumab in Japan to Daiichi Sankyo. R&D expenses are
expected to increase in the fourth quarter versus the third quarter. For
the full year, R&D expenses are expected to be below 2006 levels.
Selling, general and administrative (SG&A) expenses increased
3 percent to $804 million in the third quarter of 2007 versus $782
million in the third quarter of 2006. The increase was principally due
to higher legal costs associated with ongoing litigation and higher
Wyeth profit share expenses due to ENBREL sales growth partially offset
by lower promotion and advertising spending on marketed products. SG&A
expense growth was essentially flat year-over-year excluding higher
Wyeth profit share expenses. As in the past, SG&A expenses are expected
to increase in the fourth quarter versus the third quarter, though not
as much as in 2006.
During the third quarter of 2007, adjusted EPS grew 4 percent while
revenue remained unchanged. Adjusted EPS leverage of 4 percentage points
for the third quarter was principally driven by fewer shares used in the
computation of adjusted diluted EPS partially offset by higher interest
expense.
Average diluted shares for adjusted EPS in the third quarter of 2007
were 1,089 million versus 1,174 million in the third quarter of 2006.
Capital expenditures for the third quarter of 2007 were approximately
$306 million versus $376 million in the third quarter of 2006. Capital
expenditures for the full year 2007 are expected to be approximately
$1.4 billion versus $1.2 billion in the full year 2006. Worldwide cash
and marketable securities were $6.0 billion and debt was $11.3 billion
at the end of the third quarter of 2007.
The Company reaffirmed its 2007 adjusted EPS guidance range of $4.13 to
$4.23 excluding stock option expense and certain other expenses.
Third Quarter Product and Pipeline Update
The Company provided updates on selected late-stage clinical programs
including Aranesp, Vectibix, ENBREL, romiplostim (formerly known as AMG
531) and denosumab.
Aranesp: The Company provided an update on its discussions with
regulatory agencies regarding product labeling revisions to its ESA
products. The Company is working closely with the Food and Drug
Administration (FDA) to complete revisions to its U.S. labels based on
both the Oncologics Drugs Advisory Committee (ODAC) and Cardiovascular
and Renal Drugs Advisory Committee (CRDAC) recommendations. As
previously announced the European Medicines Agency's (EMEA) Committee
for Medicinal Products for Human Use (CHMP) has communicated a proposal
for amending prescribing information for ESAs in the European Union
(E.U.), including Aranesp. The proposed amendments are expected to be
finalized by the end of the year.
Vectibix: The Company previously announced that the CHMP issued a
positive opinion recommending Vectibix for conditional approval in the
E.U. for patients with refractory metastatic colorectal cancer (mCRC)
with non-mutated (wild-type) KRAS genes. The Company will
continue to integrate KRAS and other biomarker analyses into its
ongoing clinical program studying Vectibix in earlier lines of mCRC
therapy in combination with chemotherapy, as well as in other tumor
types. As a result, the protocols of the Phase 3 studies of Vectibix in
the treatment of 1st and 2nd
line colorectal cancer are being amended. As part of these
modifications, the Company plans to increase enrollment in both studies
which will extend the completion of these studies versus previously
planned timelines. These study changes are expected to allow the Company
to assess the utility of Vectibix in patients with and without mutant KRAS-bearing
tumors.
The Company also announced that they and the FDA have adopted changes to
the U.S. prescribing information for Vectibix based on the results of
the PACCE trial. The update is intended to highlight to clinicians the
greater risk seen when Vectibix is combined with Avastin®
and the specific chemotherapy used in the PACCE trial to treat patients
with 1st line mCRC. Vectibix is not indicated
for the 1st line treatment of mCRC and the new
safety information applies to an unapproved use of Vectibix.
ENBREL: The Company and Wyeth Pharmaceuticals, a division
of Wyeth, have submitted a supplemental Biologics License Application
(sBLA) to the FDA for the use of ENBREL in treating pediatric patients
with chronic moderate to severe plaque psoriasis who have tried another
therapy. If approved by the FDA, ENBREL is expected to be the first
biologic, as well as the first systemic medication, indicated to treat
this disease in pediatric patients.
Romiplostim (AMG 531): The Company has filed for FDA approval of
romiplostim for the treatment of thrombocytopenia in adult patients with
chronic immune (idiopathic) thrombocytopenic purpura (ITP) and expects
to file in the E.U., Canada and Australia by the end of 2007.
Romiplostim successfully met all key endpoints in its pivotal Phase 3
studies and data from both studies as well as a long-term extension
study will be presented at the American Society of Hematology (ASH)
later this year.
Denosumab: Denosumab is still on target for review of the entire
Postmenopausal Osteoporosis (PMO) data set in the second half of 2008.
The Company disclosed that its Phase 2 PMO study in Japan met its
primary and secondary endpoints.
For more product information or the full prescribing information,
please refer to the Amgen Web site at www.amgen.com.
As previously announced, the Company has posted in the Investors section
of the Company’s Web site (www.amgen.com/investors)
a slide presentation related to its third quarter financial results
conference call, scheduled for 2 p.m. Pacific Time today. The conference
call will be broadcast over the Internet and can also be found on Amgen’s
Web site at the above web address.
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 Dec. 31,
2006, 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, clinical and
regulatory developments (domestic or foreign) involving current and
future products, sales growth of recently launched products, competition
from other products (domestic or foreign) and difficulties or delays in
manufacturing our products. In addition, sales of our products are
affected by reimbursement policies imposed by third-party payors,
including governments, private insurance plans and managed care
providers and may be affected by regulatory, clinical and guideline
developments and domestic and international trends toward managed care
and health care cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others’
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 safety, side effects or manufacturing problems
with our products after they are on the market. Our business may be
impacted by government investigations, litigation and product liability
claims. Further, 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. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain of
our current products and product candidate development. 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. Further,
some raw materials, medical devices and component parts for our products
are supplied by sole third-party suppliers.
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. To learn more about our pioneering science and our vital
medicines, visit www.amgen.com.
Amgen Inc. Condensed Consolidated Statements of Operations and Reconciliation of GAAP Earnings to "Adjusted" Earnings -
Excluding Stock Option Expense (In millions, except per share data) (Unaudited)
Three Months Ended Three Months Ended September 30, 2007 September 30, 2006
GAAP
Adjustments
"Adjusted,"
Excluding Stock Option Expense
GAAP
Adjustments
"Adjusted,"
Excluding Stock Option Expense
Revenues:
Product sales
$
3,524
$
-
$
3,524
$
3,503
$
-
$
3,503
Other revenues
87
-
87
109
-
109
Total revenues
3,611
-
3,611
3,612
-
3,612
Operating expenses:
Cost of sales (excludes amortization of acquired intangible assets
presented below)
792
(4
)
(a)
585
489
(4
)
(a)
485
(113
)
(b)
(90
)
(c)
Research and development
776
(20
)
(a)
699
872
(21
)
(a)
835
(18
)
(b)
(16
)
(d)
(17
)
(d)
(22
)
(e)
Selling, general and administrative
730
(18
)
(a)
804
807
(25
)
(a)
782
92
(b)
Write-off of acquired in-process R&D
590
(590
)
(f)
-
-
-
-
Amortization of intangible assets
76
(73
)
(g)
-
122
(73
)
(g)
-
(3
)
(h)
(49
)
(h)
Other items
254
(254
)
(b)
-
-
-
-
Total operating expenses
3,218
(1,130
)
2,088
2,290
(188
)
2,102
Operating income
393
1,130
1,523
1,322
188
1,510
Interest and other income, net
(21
)
-
(21
)
39
-
39
Income before income taxes
372
1,130
1,502
1,361
188
1,549
Provision for income taxes
171
150
(m )
321
259
66
(n)
325
Net income
$
201
$
980
$
1,181
$
1,102
$
122
$
1,224
Earnings per share:
Basic
$
0.19
$
1.09
$
0.94
$
1.05
Diluted (o)
$
0.18
$
1.08
(a)
$
0.94
$
1.04
(a)
Average shares used in calculation of earnings per share:
Basic
1,086
1,086
1,167
1,167
Diluted (o)
1,090
1,089
1,178
1,174
(a)-(o) See explanatory notes below.
Amgen Inc. Condensed Consolidated Statements of Operations and Reconciliation of GAAP Earnings to "Adjusted" Earnings -
Excluding Stock Option Expense (In millions, except per share data) (Unaudited)
Nine Months Ended Nine Months Ended September 30, 2007 September 30, 2006
GAAP
Adjustments
"Adjusted,"
Excluding Stock Option Expense
GAAP
Adjustments
"Adjusted,"
Excluding Stock Option Expense
Revenues:
Product sales
$
10,693
$
-
$
10,693
$
10,121
$
-
$
10,121
Other revenues
333
-
333
312
-
312
Total revenues
11,026
-
11,026
10,433
-
10,433
Operating expenses:
Cost of sales (excludes amortization of acquired intangible assets
presented below)
1,942
(12
)
(a)
1,690
1,534
(5
)
(a)
1,529
(113
)
(b)
(90
)
(c)
(7
)
(i)
(30
)
(j)
Research and development
2,444
(68
)
(a)
2,279
2,315
(78
)
(a)
2,188
(18
)
(b)
(32
)
(d)
(54
)
(d)
(17
)
(e)
(25
)
(e)
Selling, general and administrative
2,360
(60
)
(a)
2,392
2,336
(96
)
(a)
2,233
92
(b)
(7
)
(e)
Write-off of acquired in-process R&D
590
(590
)
(f)
-
1,101
(1,101
)
(f)
-
Amortization of intangible assets
224
(221
)
(g)
-
296
(247
)
(g)
-
(3
)
(h)
(49
)
(h)
Other items
543
(543
)
(b)
-
-
-
-
Total operating expenses
8,103
(1,742
)
6,361
7,582
(1,632
)
5,950
Operating income
2,923
1,742
4,665
2,851
1,632
4,483
Interest and other income, net
(20
)
51
(k)
31
140
-
140
Income before income taxes
2,903
1,793
4,696
2,991
1,632
4,623
Provision for income taxes
572
92
(l)
980
874
189
(n)
1,063
316
(m )
Net income
$
2,331
$
1,385
$
3,716
$
2,117
$
1,443
$
3,560
Earnings per share:
Basic
$
2.07
$
3.30
$
1.79
$
3.01
Diluted (o)
$
2.06
$
3.29
(a)
$
1.77
$
2.99
(a)
Average shares used in calculation of earnings per share:
Basic
1,127
1,127
1,181
1,181
Diluted (o)
1,133
1,131
1,194
1,190
(a)-(o) See explanatory notes below.
Amgen Inc. Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings -
Excluding Stock Option Expense (In millions, except per share data) (Unaudited)
(a)
To exclude the impact of stock option expense recorded in accordance
with Statement of Financial Accounting Standards ("SFAS") No. 123R.
For the three and nine months ended September 30, 2007 and 2006, the
total pre-tax expense for employee stock options in accordance with
SFAS No. 123R was $42 million and $140 million and $50 million and
$179 million, respectively.
"Adjusted" diluted EPS including the impact of stock option expense
for the three and nine months ended September 30, 2007 and 2006 was
as follows:
Three Months Ended Nine Months Ended September 30, September 30,
2007
2006
2007
2006
"Adjusted" diluted EPS, excluding stock option expense
$
1.08
$
1.04
$
3.29
$
2.99
Impact of stock option expense
(0.02
)
(0.03
)
(0.09
)
(0.11
)
"Adjusted" diluted EPS, including stock option expense
$
1.06
$
1.01
$
3.20
$
2.88
(b)
The following table summarizes the (expense)/income amounts related
to the restructuring plan (in millions):
Three Months Ended September 30, 2007 Separation Costs (1) Asset Impairment (2) Accelerated Depreciation (3) Other (4) Total
Cost of sales (excluding amortization of intangible assets)
$
1
$
(4
)
$
(110
)
$
-
$
(113
)
Research and development (R&D)
17
(35
)
-
-
(18
)
Selling, general and administrative (SG&A)
9
-
-
83
92
Other items
(104
)
(71
)
-
(79
)
(254
)
$
(77
)
$
(110
)
$
(110
)
$
4
$
(293
)
Nine Months Ended September 30, 2007 Separation Costs (1) Asset Impairment (2) Accelerated Depreciation (3) Other (4) Total
Cost of sales (excluding amortization of intangible assets)
$
1
$
(4
)
$
(110
)
$
-
$
(113
)
Research and development (R&D)
17
(35
)
-
-
(18
)
Selling, general and administrative (SG&A)
9
-
-
83
92
Other items
(107
)
(357
)
-
(79
)
(543
)
$
(80
)
$
(396
)
$
(110
)
$
4
$
(582
)
(1)
To exclude severance and other separation costs partially offset
by the reversal of previously accrued expenses for bonuses and
stock-based compensation awards, which will be forfeited as a
result of the employees' termination.
(2)
To exclude asset impairment charges incurred in connection with the
rationalization of our worldwide manufacturing operations in order
to gain cost efficiencies and, to a lesser degree, the moderation of
the expansion of our research facilities.
(3)
To exclude accelerated depreciation resulting from our decision to
accelerate the closure of one of our ENBREL commercial bulk
production operations in connection with the rationalization of our
worldwide network of manufacturing facilities. The decision to
accelerate the closure of this manufacturing operation was
principally based on a thorough review of the supply plan for bulk
ENBREL inventory across its worldwide manufacturing network,
including consideration of expected increases in manufacturing
yields, and the determination that the related assets had no future
uses in the Company's operations. The amount included in the table
above represents the excess of accelerated depreciation expense over
the depreciation that would otherwise have been recorded if there
were no plans to accelerate the closure of this manufacturing
operation.
(4)
To exclude from SG&A the cost recoveries for certain restructuring
expenses, principally with respect to accelerated depreciation, in
connection with our co-promotion agreement with Wyeth. Also, to
exclude from Other items charges principally related to loss
accruals for leases for certain research and development
facilities that will not be used in our business.
(c)
To exclude the write-off of inventory principally due to changing
regulatory and reimbursement environments.
(d)
To exclude for the applicable periods the ongoing, non-cash
amortization of the R&D technology intangible assets acquired with
the acquisition of Abgenix, Inc. ("Abgenix"), effective April 1,
2006, and Avidia, Inc. ("Avidia"), effective October 24, 2006. The
non-cash charge for 2007 is currently estimated to be
approximately $71 million, pre-tax.
(e)
To exclude for the applicable periods merger related expenses
incurred due to the Alantos Pharmaceutical Holding, Inc.
("Alantos"), Ilypsa, Inc. ("Ilypsa"), Abgenix and Tularik Inc.
("Tularik") acquisitions, primarily related to incremental costs
associated with retention and/or integration. Substantially all
related amounts have been incurred.
(f)
To exclude for the applicable periods the non-cash expense
associated with writing-off the acquired in-process research and
development ("IPR&D") related to the acquisitions of Abgenix in
2006 and Alantos and Ilypsa in 2007.
(g)
To exclude the ongoing, non-cash amortization of acquired product
technology rights, primarily ENBREL, related to the Immunex
Corporation ("Immunex") acquisition. The non-cash charge for 2007 is
currently estimated to be approximately $295 million, pre-tax.
(h)
To exclude the impairment of a non-ENBREL related intangible asset
previously acquired in the Immunex acquisition.
(i)
To exclude merger related expenses incurred due to the Abgenix
acquisition, primarily related to incremental costs associated with
recording inventory acquired at fair value which is in excess of our
manufacturing cost.
(j)
To exclude the impact of writing-off the cost of a semi-completed
manufacturing asset that will not be used due to a change in
manufacturing strategy.
(k)
To exclude the pro rata portion of the deferred financing and
related costs that were immediately charged to interest expense as a
result of certain holders of the convertible notes due in 2032
exercising their March 1, 2007 put option and the related
convertible notes being repaid in cash.
(l)
To exclude the income tax benefit recognized as the result of
resolving certain non-routine transfer pricing issues with the
Internal Revenue Service for prior periods.
(m)
To reflect the tax effect of the above adjustments for 2007,
excluding for the applicable periods: (1) certain of the
restructuring charges (see (b) above), (2) certain components of
the write-off of inventory (see (c) above), (3) the write-off of
the acquired IPR&D related to the Alantos and Ilypsa acquisitions
(see (f) above), (4) the write-off of the cost of a semi-completed
manufacturing asset (see (j) above), and (5) the tax benefit
recognized as a result of resolving certain non-routine transfer
pricing issues with the IRS (see (l) above).
(n)
To reflect the tax effect of the above adjustments for 2006,
excluding for the nine-month period the write-off of the acquired
IPR&D related to the Abgenix acquisition (see (f) above).
(o)
The following table presents the computations for GAAP and
"Adjusted" diluted earnings per share, computed under the treasury
stock method. "Adjusted" earnings per share presented below excludes
stock option expense:
Three Months Ended Three Months Ended September 30, 2007 September 30, 2006 GAAP
"Adjusted," Excluding Stock Option Expense GAAP
"Adjusted," Excluding Stock Option Expense
Income (Numerator):
Net income for basic and diluted EPS
$
201
$
1,181
$
1,102
$
1,224
Shares (Denominator):
Weighted-average shares for basic EPS
1,086
1,086
1,167
1,167
Effect of dilutive securities
4
3
(A)
11
7
(A)
Weighted-average shares for diluted EPS
1,090
1,089
1,178
1,174
Diluted earnings per share
$
0.18
$
1.08
$
0.94
$
1.04
Nine Months Ended Nine Months Ended September 30, 2007 September 30, 2006 GAAP
"Adjusted," Excluding Stock Option Expense GAAP
"Adjusted," Excluding Stock Option Expense
Income (Numerator):
Net income for basic and diluted EPS
$
2,331
$
3,716
$
2,117
$
3,560
Shares (Denominator):
Weighted-average shares for basic EPS
1,127
1,127
1,181
1,181
Effect of dilutive securities
6
4
(A)
13
9
(A)
Weighted-average shares for diluted EPS
1,133
1,131
1,194
1,190
Diluted earnings per share
$
2.06
$
3.29
$
1.77
$
2.99
(A)
Dilutive securities used to compute "Adjusted" diluted earnings per
share for the three and nine months ended September 30, 2007 and
2006 were computed exclusive of the methodology used to determine
dilutive securities under SFAS No. 123R.
Amgen Inc. Product Sales Detail by Product and Geographic Region (In millions) (Unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2007
2006 2007
2006
Aranesp® - U.S.
$
460
$
720
$
1,692
$
2,029
Aranesp® -
International
358
347
1,095
986
EPOGEN® - U.S.
602
633
1,851
1,850
Neulasta® -
U.S.
598
560
1,744
1,636
NEUPOGEN® -
U.S.
232
212
636
609
Neulasta® -
International
165
130
472
363
NEUPOGEN® -
International
105
96
307
291
Enbrel® - U.S.
777
669
2,247
1,983
Enbrel® -
International
44
36
127
104
Sensipar® -
U.S.
88
61
241
163
Sensipar® -
International
34
22
94
60
Vectibix™ - U.S.
41
-
137
-
Other product sales - U.S.
11
9
24
26
Other product sales - International
9
8
26
21
Total product sales
$
3,524
$
3,503
$
10,693
$
10,121
U.S.
$
2,809
$
2,864
$
8,572
$
8,296
International
715
(a)
639
2,121
(b)
1,825
Total product sales
$
3,524
(a)
$
3,503
$
10,693
(b)
$
10,121
(a)
For the third quarter of 2007, the change in foreign exchange rates
positively impacted product sales by $46 million. Excluding this
impact, total product sales would have decreased 1 percent and
international product sales would have increased 5 percent over the
prior year amounts.
(b)
For the nine months ended September 30, 2007, the change in foreign
exchange rates positively impacted product sales by $129 million.
Excluding this impact, total product sales would have increased 4
percent and international product sales would have increased 9
percent over the prior year amounts.
Amgen Inc. Condensed Consolidated Balance Sheets - GAAP (In millions) (Unaudited)
September 30, December 31, 2007 2006 Assets
Current assets:
Cash and marketable securities
$
5,950
$
6,277
Trade receivables, net
2,154
2,124
Inventories
2,076
1,903
Other current assets
1,526
1,408
Total current assets
11,706
11,712
Property, plant and equipment, net
5,922
5,921
Intangible assets, net
3,445
3,747
Goodwill
11,314
11,302
Other assets
1,065
1,106
Total assets
$
33,452
$
33,788
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities
$
4,092
$
5,144
Convertible notes
-
1,698
(a)
Other debt
136
100
Total current liabilities
4,228
6,942
Deferred tax liabilities
294
367
Convertible notes
5,080
5,080
Other long-term debt
6,097
2,134
Other non-current liabilities
848
301
Stockholders' equity
16,905
18,964
Total liabilities and stockholders' equity
$
33,452
$
33,788
Shares outstanding
1,087
1,166
(a)
On March 2, 2007, as a result of certain holders of the convertible
notes due in 2032 exercising their March 1, 2007 put option, the
Company repurchased $1,702 million, or substantially all of the
outstanding convertible notes due in 2032 at their then-accreted
value for cash. Accordingly, the convertible notes repurchased were
classified as current liabilities and the remaining notes were
classified as non-current liabilities at December 31, 2006.
Amgen Inc. Reconciliation of "Adjusted" Earnings Per Share Guidance to GAAP Earnings Per Share Guidance for the Year Ending December 31, 2007
2007
"Adjusted" earnings per share guidance - excluding stock option
expense
(a)
$ 4.13
-
$ 4.23
Known adjustments to arrive at GAAP earnings:
Restructuring costs
(b)
(0.51)
-
(0.53)
Write-off of Alantos and Ilypsa acquired in-process research &
development
(c)
(0.53)
Amortization of acquired intangible assets, product technology rights
(d)
(0.16)
Stock option expense
(e)
(0.10)
-
(0.12)
Tax settlement
(f)
0.08
Write-off of excess inventory
(g)
(0.07)
Amortization of acquired intangible assets, R&D technology rights
(h)
(0.04)
Write-off the cost of a semi-completed manufacturing asset
(i)
(0.03)
Write-off of deferred financing and related costs
(j)
(0.03)
Other merger-related expenses
(k)
(0.02)
GAAP earnings per share guidance
$ 2.68
-
$ 2.82
(a)
On October 24, 2007, the Company reaffirmed its adjusted earnings
per share guidance, excluding stock option expense.
(b)
To exclude restructuring related costs including asset impairment
charges, accelerated depreciation, loss accruals for certain
leases and staff separation costs.
(c)
To exclude the non-cash expense associated with writing-off the
acquired IPR&D related to the acquisitions of Alantos and Ilypsa.
(d)
To exclude the ongoing, non-cash amortization of acquired product
technology rights, primarily ENBREL, related to the Immunex
acquisition. The non-cash charge for 2007 is estimated to be
approximately $295 million, pre-tax.
(e)
To exclude the estimated stock option expense associated with
Amgen's adoption of Statement of Financial Accounting Standards
No. 123R.
(f)
To exclude the income tax benefit recognized as the result of
resolving certain non-routine transfer pricing issues with the
Internal Revenue Service for prior periods.
(g)
To exclude the write-off of inventory principally due to changing
regulatory and reimbursement environments.
(h)
To exclude the ongoing, non-cash amortization of the Research &
Development technology intangible assets acquired with the Abgenix
and Avidia acquisitions. The total non-cash charge for 2007 is
estimated to be approximately $71 million, pre-tax.
(i)
To exclude the impact of writing-off the cost of a semi-completed
manufacturing asset that will not be used due to a change in
manufacturing strategy.
(j)
To exclude the pro rata portion of the deferred financing and
related costs that were immediately charged to interest expense as
a result of certain holders of the convertible notes due in 2032
exercising their March 1, 2007 put option and the related
convertible notes being repaid in cash.
(k)
To exclude other merger related expenses incurred due to the
Tularik, Abgenix, Avidia, Alantos and Ilypsa acquisitions.
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