Navigation Links
Amgen's Third Quarter 2008 Adjusted Earnings Per Share Increased 14 Percent to $1.23
Date:10/22/2008

Third Quarter 2008 Revenue Increased 7 Percent to $3.9 Billion Third Quarter 2008 GAAP Earnings Per Share were $1.09, an Increase from

Third Quarter 2007 GAAP Earnings Per Share of $0.18 Full Year Revenue Guidance Raised from $14.6 Billion - $14.9 Billion to

$14.9 Billion - $15.2 Billion Full Year Adjusted EPS Guidance Raised from $4.25 - $4.45 to $4.45 - $4.55

THOUSAND OAKS, Calif., Oct. 22 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) reported adjusted earnings per share (EPS), excluding stock option expense and certain other expenses, of $1.23 for the third quarter of 2008, an increase of 14 percent compared to $1.08 for the third quarter of 2007. Adjusted net income, excluding stock option expense and certain other expenses, increased 11 percent to $1,308 million in the third quarter of 2008 compared to $1,181 million in the third quarter of 2007. Stock option expense on a per share basis totaled 2 cents for both the third quarter of 2008 and the third quarter of 2007.

Total revenue increased 7 percent during the third quarter of 2008 to $3,875 million versus $3,611 million in the third quarter of 2007.

Adjusted EPS and adjusted net income for the third quarter 2008 and 2007 exclude, for the applicable periods, 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 in the notes to the attached reconciliation tables.

Calculated in accordance with United States (U.S.) Generally Accepted Accounting Principles (GAAP), Amgen's GAAP EPS were $1.09 in the third quarter of 2008 compared to $0.18 in the same quarter last year. GAAP net income was $1,158 million in the third quarter of 2008 compared to $201 million in the third quarter of 2007. GAAP reported results for the thirdates 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.

Amgen Inc.

Condensed Consolidated Statements of Income and

Reconciliation of GAAP Earnings to "Adjusted" Earnings

(In millions, except per share data)

(Unaudited)

Three Months Ended Three Months Ended

September 30, 2008 September 30, 2007

----------------------------- ------------------------------

GAAP Adjustments "Adjusted" GAAP Adjustments "Adjusted"

----------------------------- ------------------------------

Revenues:

Product

sales $3,784 $- $3,784 $3,524 $- $3,524

Other

revenues 91 - 91 87 - 87

------- ------- ------- ------- ------- -------

Total

revenues 3,875 - 3,875 3,611 - 3,611

------- ------- ------- ------- ------- -------

Operating

expenses:

Cost of sales

(excludes

amortization

of acquired

intangible

assets

presented

below) 677 (3) (a) 590 792 (4) (a) 585

(84) (b) (113) (e)

(90) (h)

Research and

development 729 (12) (a) 700 776 (20) (a) 699

(17) (c) (18) (e)

(17) (c)

(22) (i)

Selling,

general and

administr-

ative 900 (10) (a) 890 730 (18) (a) 804

92 (e)

Write-off of

acquired

in-process

R&D - - 590 (590) (j) -

Amortization of

intangible

assets 74 (74) (d) - 76 (73) (d) -

(3) (k)

Other

charges 12 (8) (e) - 254 (254) (e) -

(4) (f)

------- ------- ------- ------- ------- -------

Total

operating

expenses 2,392 (212) 2,180 3,218 (1,130) 2,088

------- ------- ------- ------- ------- -------

Operating

income 1,483 212 1,695 393 1,130 1,523

Interest and

other income

and (expense),

net (12) 9 (g) (3) (21) - (21)

------- ------- ------- ------- ------- -------

Income before

income taxes 1,471 221 1,692 372 1,130 1,502

Provision for

income taxes 313 71 (o) 384 171 150 (q) 321

------- ------- ------- ------- ------- -------

Net income $1,158 $150 $1,308 $201 $980 $1,181

======= ======= ======= ======= ======= =======

Earnings per

share:

Basic $1.09 $1.24 $0.19 $1.09

Diluted (r) $1.09 $1.23 (a) $0.18 $1.08 (a)

Average shares

used in

calculation

of earnings

per share:

Basic 1,058 1,058 1,086 1,086

Diluted (r) 1,064 1,063 (a) 1,090 1,089 (a)

(a) - (r) See explanatory notes on the following pages.

Amgen Inc.

Condensed Consolidated Statements of Income and

Reconciliation of GAAP Earnings to "Adjusted" Earnings

(In millions, except per share data)

(Unaudited)

Nine months ended Nine months ended

September 30, 2008 September 30, 2007

----------------------------- ------------------------------

GAAP Adjustments "Adjusted" GAAP Adjustments "Adjusted"

----------------------------- ------------------------------

Revenues:

Product

sales $11,013 $- $11,013 $10,693 $- $10,693

Other

revenues 239 - 239 333 - 333

------- ------- ------- ------- ------- -------

Total

revenues 11,252 - 11,252 11,026 - 11,026

Operating

expenses:

Cost of

sales

(excludes

amortization

of acquired

intangible

assets

presented

below) 1,738 (9) (a) 1,644 1,942 (12) (a) 1,690

(84) (b) (113) (e)

(1) (e) (90) (h)

(30) (l)

(7) (m)

Research and

development 2,232 (35) (a) 2,140 2,444 (68) (a) 2,279

(53) (c) (54) (c)

(3) (e) (25) (i)

(1) (i) (18) (e)

Selling,

general and

administr-

ative 2,678 (33) (a) 2,646 2,360 (60) (a) 2,392

1 (e) 92 (e)

Write-off of

acquired

in-process

R&D - - 590 (590) (j) -

Amortization of

intangible

assets 221 (221) (d) - 224 (221) (d) -

(3) (k)

Other

charges 306 (39) (e) - 543 (543) (e) -

(267) (f)

------- ------- ------- ------- ------- -------

Total

operating

expenses 7,175 (745) 6,430 8,103 (1,742) 6,361

Operating

income 4,077 745 4,822 2,923 1,742 4,665

Interest and

other income

and (expense),

net 19 9 (g) 28 (20) 51 (n) 31

------- ------- ------- ------- ------- -------

Income before

income taxes 4,096 754 4,850 2,903 1,793 4,696

Provision for

income taxes 861 228 (o) 1,089 572 92 (p) 980

316 (q)

------- ------- ------- ------- ------- -------

Net income $3,235 $526 $3,761 $2,331 $1,385 $3,716

======= ======= ======= ======= ======= =======

Earnings per

share:

Basic $3.01 $3.50 $2.07 $3.30

Diluted (r) $3.00 $3.49 (a) $2.06 $3.29 (a)

Average shares

used in

calculation

of earnings

per share:

Basic 1,075 1,075 1,127 1,127

Diluted (r) 1,079 1,078 (a) 1,133 1,131 (a)

(a) - (r) See explanatory notes on the following pages.

Amgen Inc.

Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings

(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, 2008 and 2007, the

total pre-tax expense for employee stock options in accordance with

SFAS No. 123R was $25 million and $42 million, respectively, and $77

million and $140 million, respectively.

"Adjusted" diluted EPS including the impact of stock option expense

for the three and nine months ended September 30, 2008 and 2007 was

as follows:

Three months ended Nine months ended

September 30, September 30,

------------------ -----------------

2008 2007 2008 2007

------------------ -----------------

"Adjusted" diluted EPS,

excluding stock option

expense $1.23 $1.08 $3.49 $3.29

Impact of stock option

expense (net of tax) (0.02) (0.02) (0.05) (0.09)

------- ------- ------- -------

"Adjusted" diluted EPS,

including stock option

expense $1.21 $1.06 $3.44 $3.20

======= ======= ======= =======

(b) To exclude the write-off of inventory resulting from a strategic

decision to change manufacturing processes.

(c) To exclude the ongoing, non-cash amortization of the R&D technology

intangible assets acquired with the acquisitions of Abgenix, Inc.

("Abgenix") and Avidia, Inc. ("Avidia").

(d) To exclude the ongoing, non-cash amortization of acquired product

technology rights, primarily ENBREL, related to the Immunex

Corporation ("Immunex") acquisition.

(e) To exclude the following restructuring (expenses)/recoveries

associated with our restructuring plan announced in August 2007, as

follows (in millions):

Accel-

Separ- Asset erated

ation impair- deprec-

costs ment iation

(1) (2) (3) Other(4) Total

------- -------- ------- -------- ------

Three months ended

September 30, 2008

-------------------------

Other charges $- $(1) $- $(7) $(8)

------- -------- ------- -------- ------

$- $(1) $- $(7) $(8)

======= ======== ======= ======== ======

Three months ended

September 30, 2007

-------------------------

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 charges (104) (71) - (79) (254)

------- -------- ------- -------- ------

$(77) $(110) $(110) $4 $(293)

======= ======== ======= ======== ======

Nine months ended

September 30, 2008

-------------------------

Cost of sales (excluding

amortization of intangible

assets) $- $(1) $- $- $(1)

R&D (3) - - - (3)

SG&A - - - 1 1

Other charges (4) (15) - (20) (39)

------- -------- ------- -------- ------

$(7) $(16) $- $(19) $(42)

======= ======== ======= ======== ======

Nine months ended

September 30, 2007

-------------------------

Cost of sales (excluding

amortization of intangible

assets) $1 $(4) $(110) $- $(113)

R&D 17 (35) - - (18)

SG&A 9 - - 83 92

Other charges (107) (357) - (79) (543)

------- -------- ------- -------- ------

$(80) $(396) $(110) $4 $(582)

======= ======== ======= ======== ======

(1) Severance and other separation costs, partially offset in 2007 by

the reversal of previously accrued expenses for bonuses and

stock-based compensation awards, which were forfeited as a result of

the employees' termination.

(2) 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 R&D facilities.

(3) 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 amount included 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 Other charges, loss accruals for leases

principally related to certain facilities that will not be used in

our business. Also, to exclude from SG&A in 2007, the cost

recoveries for certain restructuring expenses, principally with

respect to accelerated depreciation in connection with our

co-promotion agreement with Wyeth.

(f) To exclude loss accruals for settlements of certain commercial legal

proceedings.

(g) To exclude the loss accrual on the sale of certain less

significant marketed products and related assets.

(h) To exclude the write-off of inventory principally due to changing

regulatory and reimbursement environments.

(i) To exclude, for the applicable periods, merger related expenses

incurred due to the Alantos Pharmaceutical Holding, Inc. ("Alantos"),

Ilypsa, Inc. ("Ilypsa"), and Tularik Inc. acquisitions, primarily

related to incremental costs associated with retention. Substantially

all related amounts have been incurred.

(j) To exclude the non-cash expense associated with writing-off the

acquired in-process research and development ("IPR&D") related to the

acquisitions of Alantos and Ilypsa in 2007.

(k) To exclude the impairment of a non-ENBREL related intangible asset

previously acquired in the Immunex acquisition.

(l) 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.

(m) 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.

(n) 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 our convertible notes due in 2032 exercising their

March 1, 2007 put option and the related convertible notes being

repaid in cash.

(o) To reflect the tax effect of the above adjustments for 2008, excluding

(1) certain components of the write-off of inventory (see (b) above),

(2) certain of the restructuring charges (see (e) above), (3) certain

of the loss accruals for settlements of commercial legal proceedings

(see (f) above) and (4) certain components of the loss accrual on the

sale of certain less significant marketed products and related assets

(see (g) above).

(p) To exclude the income tax benefit recognized as the result of

resolving certain non-routine transfer pricing issues with the

Internal Revenue Service ("IRS") for prior periods.

(q) To reflect the tax effect of the above adjustments for 2007, excluding

(1) certain of the restructuring charges (see(e) above), (2) certain

components of the write-off of inventory (see (h) above), (3) the

write-off of the acquired IPR&D related to the Alantos and Ilypsa

acquisitions (see (j) above), (4) the write-off of the cost of a

semi-completed manufacturing asset (see (l) above), and (5) the tax

benefit recognized as a result of resolving certain non-routine

transfer pricing issues with the IRS (see (p) above).

(r) 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, 2008 September 30, 2007

------------------- -------------------

GAAP "Adjusted" GAAP "Adjusted"

------------------- -------------------

Income (Numerator):

Net income for basic and

diluted EPS $1,158 $1,308 $201 $1,181

======= ======= ======= =======

Shares (Denominator):

Weighted-average shares

for basic EPS 1,058 1,058 1,086 1,086

Effect of dilutive

securities 6 5(*) 4 3(*)

------- ------- ------- -------

Weighted-average shares

for diluted EPS 1,064 1,063 1,090 1,089

======= ======= ======= =======

Diluted earnings per share $1.09 $1.23 $0.18 $1.08

======= ======= ======= =======

quarter of 2007 were negatively impacted by the write-offs of $590 million of acquired in-process research and development related to the acquisitions of Alantos Pharmaceutical Holdings, Inc. and Ilypsa, Inc. as well as $293 million of charges related to the previously announced restructuring plan.

"Our financial results for the third quarter demonstrate strong operating performance and we are increasing our 2008 annual guidance," said Kevin Sharer, chairman and chief executive officer. "We are now focused on plans to commercialize denosumab in post-menopausal osteoporosis. We're excited about the opportunity to bring this novel treatment option to patients with this serious disease," concluded Sharer.

Product Sales Performance

During the third quarter, total product sales increased 7 percent to $3,784 million from $3,524 million in the third quarter of 2007. Sales in the U.S. totaled $2,929 million, an increase of 4 percent versus $2,809 million in the third quarter of 2007. International sales increased 20 percent to $855 million versus $715 million for the third quarter of 2007. Changes in foreign exchange positively impacted third quarter 2008 sales by $78 million. Excluding the impact of foreign exchange, total product sales increased 5 percent and international product sales increased 9 percent.

Worldwide sales of Aranesp(R) (darbepoetin alfa) increased 3 percent to $845 million in the third quarter of 2008 versus $818 million during the third quarter of 2007. In the U.S., third quarter 2008 Aranesp sales were relatively unchanged at $458 million in the third quarter of 2008 versus $460 million in the third quarter of 2007. U.S. sales of Aranesp in the third quarter of 2008 benefited from a $54 million change in the accounting estimate related to product sales return reserves. Excluding the positive impact of this change in the accounting estimate, U.S. sales of Aranesp decreased 12 percent in the third quarter of 2008 versus the p Nine months ended Nine months ended

September 30, 2008 September 30, 2007

------------------- -------------------

GAAP "Adjusted" GAAP "Adjusted"

------------------- -------------------

Income (Numerator):

Net income for basic and

diluted EPS $3,235 $3,761 $2,331 $3,716

======= ======= ======= =======

Shares (Denominator):

Weighted-average shares

for basic EPS 1,075 1,075 1,127 1,127

Effect of dilutive

securities 4 3(*) 6 4(*)

------- ------- ------- -------

Weighted-average shares

for diluted EPS 1,079 1,078 1,133 1,131

======= ======= ======= =======

Diluted earnings per share $3.00 $3.49 $2.06 $3.29

======= ======= ======= =======

(*) Dilutive securities used to compute "Adjusted" diluted earnings per

share for the three and nine months ended September 30, 2008 and 2007

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,

------------------ -----------------

2008 2007 2008 2007

------------------ -----------------

Aranesp(R) - U.S. $458 $460 $1,290 $1,692

Aranesp(R) - International 387 358 1,141 1,095

EPOGEN(R) - U.S. 634 602 1,810 1,851

Neulasta(R) - U.S. 633 598 1,850 1,744

NEUPOGEN(R) - U.S. 223 232 667 636

Neulasta(R) - International 219 165 620 472

NEUPOGEN(R) - International 117 105 342 307

Enbrel(R) - U.S. 838 777 2,531 2,247

Enbrel(R) - International 55 44 154 127

Sensipar(R) - U.S. 111 88 306 241

Sensipar(R) - International 50 34 138 94

Vectibix(R) - U.S. 26 41 83 137

Vectibix(R) - International 15 - 24 -

Other product sales - U.S. 6 11 23 24

Other product sales - International 12 9 34 26

------- ------- ------- -------

Total product sales $3,784 $3,524 $11,013 $10,693

======= ======= ======= =======

U.S. $2,929 $2,809 $8,560 $8,572

International 855 715 2,453 2,121

------- ------- ------- -------

Total product sales $3,784 $3,524 $11,013 $10,693

======= ======= ======= =======

Amgen Inc.

Condensed Consolidated Balance Sheets - GAAP

(In millions)

(Unaudited)

September 30, December 31,

2008 2007

------------- -------------

Assets

Current assets:

Cash, cash equivalents and

marketable securities $9,757 $7,151

Trade receivables, net 2,114 2,101

Inventories 2,004 2,091

Other current assets 1,745 1,698

------------- -------------

Total current assets 15,620 13,041

Property, plant and equipment, net 5,972 5,941

Intangible assets, net 3,095 3,332

Goodwill 11,340 11,240

Other assets 971 1,085

------------- -------------

Total assets $36,998 $34,639

============= =============

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable and accrued

liabilities $3,951 $4,179

Current portion of other long-term

debt 1,000 2,000

------------- -------------

Total current liabilities 4,951 6,179

Deferred tax liabilities 346 480

Convertible notes 5,081 5,080

Other long-term debt 5,095 4,097

Other non-current liabilities 1,693 934

Stockholders' equity 19,832 17,869

------------- -------------

Total liabilities and

stockholders' equity $36,998 $34,639

============= =============

Shares outstanding 1,059 1,087

Amgen Inc.

Reconciliation of "Adjusted" Earnings Per Share Guidance to GAAP

Earnings Per Share Guidance for the Year Ending December 31, 2008

2008

-------------------

"Adjusted" earnings per share guidance $4.45 - $4.55

Known adjustments to arrive at GAAP earnings:

Legal settlements (a) (0.19)

Amortization of acquired intangible assets,

product technology rights (b) (0.17)

Stock option expense (c) (0.06) - (0.08)

Write-off of inventory (d) (0.06)

Restructuring costs (e) (0.03) - - (0.05)

Amortization of acquired intangible assets,

R&D technology rights (f) (0.04)

Loss on sale of less significant marketed

products (g) (0.01)

-------------------

GAAP earnings per share guidance $3.85 - $3.99

===================

(a) To exclude loss accruals for settlements of certain commercial legal

proceedings.

(b) To exclude the ongoing, non-cash amortization of acquired product

technology rights, primarily ENBREL, related to the Immunex

acquisition.

(c) To exclude stock option expense associated with SFAS No. 123R.

(d) To exclude the write-off of inventory resulting from a strategic

decision to change manufacturing processes.

(e) To exclude restructuring related costs.

(f) To exclude the ongoing, non-cash amortization of the R&D technology

intangible assets acquired with the Abgenix and Avidia acquisitions.

(g) To exclude the loss accrual on the sale of certain less significant

marketed products and related assets.

CONTACT: Amgen, Thousand Oaks

David Polk, 805-447-4613 (media)

Arvind Sood, 805-447-1060 (investors)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

rior year. The decline in U.S. Aranesp sales reflects the negative impact on demand, primarily in the supportive cancer care setting, from regulatory and reimbursement changes which principally occurred in the second half of 2007, and additional product label changes which occurred in the third quarter of 2008. The decline in demand in the third quarter of 2008 was slightly offset by an increase in the average net sales price. International Aranesp sales increased 8 percent to $387 million versus $358 million in the third quarter of 2007 due to changes in foreign exchange which positively impacted third quarter 2008 sales by approximately $35 million, partially offset by pricing pressure and ESA (erythropoiesis stimulating agent) dosing conservatism versus the prior year. Excluding the impact of foreign exchange, international product sales decreased 2 percent. Excluding the positive change in the accounting estimate related to product sales return reserves and foreign exchange gains, worldwide product sales decreased 8 percent in the third quarter of 2008 versus the prior year.

Sales of EPOGEN(R) (Epoetin alfa) increased 5 percent to $634 million in the third quarter of 2008 versus $602 million in the third quarter of 2007, primarily due to an increase in the average net sales price, favorable changes in wholesaler inventory levels and revised estimates of dialysis demand (primarily spillover) for prior quarters. Increased demand due to patient population growth was offset by a decline in dose / utilization within certain settings. Spillover is a result of the Company's contractual relationship with Johnson & Johnson. (Please refer to the Company's Form 10-K for a more detailed discussion of this relationship and a description of spillover).

Combined worldwide sales of Neulasta(R) (pegfilgrastim) and NEUPOGEN(R) (Filgrastim) increased 8 percent to $1,192 million in the third quarter of 2008 versus $1,100 million for the third quarter of 2007, driven primarily by increased demand for Neulasta. Combined sales of Neulasta and NEUPOGEN in the U.S. were $856 million in the third quarter of 2008 versus $830 million in the third quarter of 2007, an increase of 3 percent primarily reflecting an increase in demand for Neulasta. This increase in demand was driven by an increase in the average net sales price, partially offset by a decline in units sold, which we believe was primarily due to customer stocking which occurred in the second quarter of 2008. Combined international sales increased 24 percent to $336 million in the third quarter of 2008 versus $270 million for the same quarter in the prior year. This growth reflects changes in foreign exchange which positively impacted third quarter 2008 combined international sales by approximately $33 million, as well as increased demand driven by the continued conversion from NEUPOGEN to Neulasta. Excluding the impact of foreign exchange, combined worldwide product sales increased 5 percent and international product sales increased 12 percent.

Sales of Enbrel(R) (etanercept) increased 9 percent in the third quarter to $893 million versus $821 million during the same period in 2007. Sales growth was driven by higher demand due to increases in both average net sales price and patients. ENBREL sales growth in the third quarter was affected by share declines in the U.S. versus the third quarter of 2007 due to increased competitive activity. However, sales growth continued in both rheumatology and dermatology, and ENBREL continues to maintain a leading position in both segments.

Worldwide sales of Sensipar(R) (cinacalcet) increased 32 percent to $161 million in the third quarter of 2008 versus $122 million during the third quarter of 2007. This growth was principally driven by demand, primarily due to segment penetration.

Vectibix(R) (panitumumab) sales for the third quarter were unchanged year over year at $41 million.

Operating Expense Analysis on an Adjusted Basis:

Cost of sales increased 1 percent to $590 million in the third quarter of

2008 versus $585 million in the third quarter of 2007. This increase was

due to higher sales volume offset by lower excess inventory write-offs,

lower excess capacity charges and lower cost ENBREL. The Company now

expects full year 2008 adjusted Cost of Sales expense as a percent of

sales to be approximately 15 percent.

Research & Development (R&D) expenses were relatively unchanged at $700

million in the third quarter of 2008 versus $699 million in the third

quarter of 2007. Higher staff-related costs as well as clinical trial

spend for our emerging pipeline were offset by lower clinical trial costs

for our denosumab registrational studies due to completion of enrollment

and the benefit derived from our licensing transaction with Takeda in

Japan. The Company now expects full year 2008 adjusted R&D expense

dollars to be slightly lower than 2007. Consistent with historical

spending patterns, the Company expects an increase in the fourth quarter

versus the third quarter that should be similar in magnitude to the

increase in 2007, though actual results may vary depending on licensing

activities and pipeline progress.

Selling, General & Administrative (SG&A) expenses increased 11 percent to

$890 million in the third quarter of 2008 versus $804 million in the

third quarter of 2007 reflecting higher Wyeth profit share expenses and

staff-related costs offset by lower litigation expense. Wyeth profit

share expenses increased 22 percent to $298 million in the third quarter

of 2008 versus $245 million in the third quarter of 2007. The Company

still expects Wyeth profit share to be one third of adjusted SG&A

expenses for the full year 2008. Excluding Wyeth profit share, adjusted

SG&A expenses in the third quarter of 2008 increased 6 percent versus the

same quarter last year. As in the past, adjusted SG&A expenses are

expected to increase in the fourth quarter versus the third quarter. The

Company still expects 2008 adjusted SG&A expense dollars excluding Wyeth

profit share expenses to be slightly higher versus 2007.

The Company still expects the full year 2008 adjusted tax rate to be similar to 2007 as the federal R&D credit has been retroactively extended in the fourth quarter of 2008.

Average diluted shares for adjusted EPS in the third quarter of 2008 were 1,063 million versus 1,089 million in the third quarter of 2007. The Company currently has $4.9 billion remaining under its authorized stock repurchase program.

Capital expenditures for the third quarter of 2008 were approximately $159 million versus $306 million in the third quarter of 2007. The Company now expects full year 2008 capital expenditures to be approximately $750 million. Worldwide cash and marketable securities were $9.8 billion and debt was $11.2 billion at the end of the third quarter of 2008.

2008 Revenue and EPS Guidance Raised

The Company is raising its revenue guidance range from the previously provided range of $14.6 billion to $14.9 billion to an increased range of $14.9 billion to $15.2 billion. The Company is also raising its 2008 adjusted EPS guidance range from the prior range of $4.25 to $4.45 to an increased range of $4.45 to $4.55, excluding stock option expense and certain other expenses, based upon sales momentum and lower operating expense due to continuing efficiencies.

Third Quarter Product and Pipeline Update

The Company provided updates on selected products and late-stage clinical programs.

Denosumab: The Company presented full data results from its pivotal Phase 3 fracture study (FREEDOM) at the 2008 American Society of Bone and Mineral Research (ASBMR) Annual Meeting in Montreal. The study met the primary and all secondary end points.

Nplate (TM) (romiplostim): The Company noted that the U.S. Food and Drug Administration (FDA) has approved Nplate, the first and only agent that acts directly to increase platelet production for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the treatment of this chronic disease.

Nplate was also approved for ITP by Australia's Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory approval of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review.

AMG 317: The Company announced that it has reviewed interim results from a phase 2 study of AMG 317 in patients with moderate to severe asthma. The data showed evidence of biological activity; however, the clinical efficacy from the interim analysis did not meet expectations. The phase 2 study will be completed this year and results will be submitted to an appropriate peer-reviewed forum.

For more product information or the full prescribing information, please refer to the Amgen Website at http://www.amgen.com.

As previously announced, the Company has posted in the Investors section of the Company's website (http://www.amgen.com/investors) a slide presentation related to its second quarter financial results conference call, scheduled for 1:30 p.m. Pacific Time today. The conference call will be broadcast over the Internet and can also be found on Amgen's Website at the above web address.

Non-GAAP Financial Measures

Management has presented its operating results in accordance with GAAP and on an "adjusted" (or non-GAAP basis) for the three and nine months ended Sept. 30, 2008 and 2007. The Company believes that the presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses these non-GAAP financial measures in connection with its own budgeting and financial planning. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in conformity with U.S. GAAP.

About Amgen

Amgen discovers, develops, manufactures 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 http://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 Dec. 31, 2007, 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 candid
'/>"/>

SOURCE Amgen
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. CNS Response Announces Fiscal Third Quarter 2007 Results
2. Avitar Reports Third Quarter Financial Results for Fiscal 2007
3. Martek to Announce Third Quarter 2007 Results on September 5, 2007
4. Third Security, LLC Hires Two New Managing Directors
5. Wyeth Sets Webcast and Conference Call for 2007 Third Quarter Earnings
6. ThirdBiotech Networking Group Launches
7. BioMed Realty Trust Declares Third Quarter 2007 Common Stock and Preferred Stock Dividends
8. PPD Announces Third Quarter 2007 Earnings Release, Webcast and Conference Call
9. Boston Scientific to Webcast Conference Call Discussing Third Quarter Financial Results
10. Vasogen Announces Third Quarter Conference Call and Webcast of Bio InvestorForum 2007 Presentation
11. Americas Heartland Launches Third Season Highlighting Contributions of American Farmers and Ranchers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... , Feb. 10, 2016  The Maryland House ... , has announced that University of Maryland School of ... MBA and University of Maryland Medical System President and ... the "Speaker,s Medallion," the highest honor given to the ... Delegates. Dean Reece and Mr. Chrencik ...
(Date:2/10/2016)...  Allergan plc (NYSE: AGN ) a leading ... , Allergan,s CEO and President, will be featured as ... the RBC Capital Markets Healthcare Conference on Tuesday, February ... York Palace Hotel in New York, NY ... can be accessed on Allergan,s Investor Relations web site ...
(Date:2/10/2016)... NC (PRWEB) , ... February 10, 2016 , ... ... anticipated expansion to their comprehensive training and support program, Sonalinkā„¢ remote monitoring. The ... HIFU procedures performed on Friday, February 5th, connecting Dr. Samuel Peretsman to a ...
(Date:2/10/2016)... ... February 09, 2016 , ... Creation Technologies, ... of the Highest Overall Customer Rating Award from Circuits Assembly , today announced ... across the USA, Canada, Mexico and China. , The EMS provider, known in ...
Breaking Biology Technology:
(Date:1/20/2016)... 20, 2016  Synaptics Incorporated (NASDAQ: SYNA ... today announced sampling of S1423, its newest ClearPad ... small screen applications including smartwatches, fitness trackers, and ... and rectangular shapes, as well as thick and ... moisture on screen, while wearing gloves, and supports ...
(Date:1/15/2016)... JUAN, Puerto Rico , Jan. 15, 2016 /PRNewswire/ ... companies big and small to find new ways to ... driven culture. iOS and Android ... device based on biometrics, transforming it into a hardware ... request that users swipe their fingerprint on their KodeKey ...
(Date:1/13/2016)... 13, 2016 ... of the  "India Biometrics Authentication & ... (2015-2020)"  report to their offering.  ... announced the addition of the  "India ... Estimation & Forecast (2015-2020)"  report ...
Breaking Biology News(10 mins):