UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
October 25, 2010
AMGEN INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-12477 | 95-3540776 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS Employer Identification No.) | ||
| One Amgen Center Drive Thousand Oaks, CA |
91320-1799 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code
805-447-1000
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition.
On October 25, 2010, Amgen Inc. (the “Company”) issued a press release announcing its unaudited results of operations for the three and nine months ended September 30, 2010 and its unaudited financial position as of September 30, 2010. The full text of the press release is set forth in Exhibit 99.1 attached hereto.
In its press release, the Company included certain historical non-U.S. Generally Accepted Accounting Principles (“non-GAAP”) financial measures as defined in Regulation G promulgated by the Securities and Exchange Commission with respect to September 30, 2010 and for the three and nine months ended September 30, 2010 and 2009. Reconciliations for such historical non-GAAP financial measures are attached to the press release set forth as Exhibit 99.1 attached hereto. The Company believes that its presentation of historical non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. These historical non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”).
As of September 30, 2010
As of September 30, 2010, the Company reported a non-GAAP financial measure for total outstanding debt which excluded the impact of adopting a new accounting standard, effective January 1, 2009, on the carrying values of its convertible notes. The Company believes that excluding the impact of this accounting standard on its total outstanding debt provides a supplemental measure that will facilitate comparisons before, during and after its convertible notes are outstanding.
Three and nine months ended September 30, 2010
For the three and nine months ended September 30, 2010, the Company’s adjustments to GAAP financial measures relate to amounts associated with: the impact of expensing stock options; the Company’s acquisitions of Avidia, Inc. in October 2006 (the “Avidia Acquisition”), Abgenix, Inc. in April 2006 (the “Abgenix Acquisition”) and Immunex Corporation in July 2002 (the “Immunex Acquisition”); the incremental non-cash interest expense resulting from a change in the accounting for our convertible notes effective January 1, 2009 (the “Non-Cash Interest Expense”); the income tax benefit recognized as a result of resolving certain non-routine transfer pricing issues with the Internal Revenue Service for prior periods (the “Income Tax Benefit”); and, for the nine months ended September 30, 2010, net awards for legal settlements (the “2010 Legal Awards”). For the three and nine months ended September 30, 2010, the Company’s adjustments to GAAP financial measures also include the tax effect of the adjustments in 2010, discussed below, excluding the Income Tax Benefit (the “2010 Tax Effect”).
For the three and nine months ended September 30, 2010, the Company reported non-GAAP financial results for cost of sales (excludes amortization of certain acquired intangible assets) (“COS”) expense, research and development (“R&D”) expense, selling, general and administrative (“SG&A”) expense, interest expense, net (“Interest expense, net”) and weighted average shares used in the calculation of adjusted diluted earnings per share. COS expense, R&D expense and SG&A expense were adjusted to exclude the effects of expensing stock options. R&D expense was also adjusted to exclude the ongoing, non-cash amortization of the R&D technology intangible assets with alternative future uses acquired with the Abgenix Acquisition and the Avidia Acquisition (the “R&D Technology Intangible Assets’ Amortization”). Interest expense, net was adjusted to exclude the Non-Cash Interest Expense. Weighted average shares used in the calculation of adjusted diluted earnings per share were adjusted to exclude the related effects of expensing stock options. The Company believes that excluding the impact of expensing stock options and the related effects of expensing stock options provide supplemental measures that will facilitate comparisons between periods before and during when such expenses are incurred. The Company believes that excluding the R&D Technology Intangible Assets’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to
2
its internally developed intellectual property. The Company believes that excluding the Non-Cash Interest Expense provides a supplemental measure that will facilitate comparisons before, during and after such expense is incurred.
For the three and nine months ended September 30, 2010, the Company reported non-GAAP adjusted provisions for income taxes, adjusted net income and adjusted earnings per share excluding, where applicable, the foregoing expense amounts and the related effects of expensing stock options on weighted average shares used in the calculation of adjusted diluted earnings per share for the reasons discussed above, the ongoing, non-cash amortization of acquired product technology rights related to the Immunex Acquisition (primarily Enbrel®) (the “Immunex Intangible Assets’ Amortization”), the 2010 Tax Effect, the Income Tax Benefit and, for the nine months ended September 30, 2010, the 2010 Legal Awards. The Company believes that excluding the Immunex Intangible Assets’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that excluding the 2010 Legal Awards and the Income Tax Benefit provide supplemental measures that will facilitate comparisons between periods in which such items did not occur. The Company believes that excluding the 2010 Tax Effect provides a supplemental measure that will facilitate comparisons before, during and after the related adjustments have occurred.
Three and nine months ended September 30, 2009
For the three and nine months ended September 30, 2009, the Company’s adjustments to GAAP financial measures relate to amounts associated with: the impact of expensing stock options; the Avidia Acquisition, the Abgenix Acquisition and the Immunex Acquisition; the Company’s restructuring plan announced in August 2007 and the additional cost saving initiatives subsequently identified (the “2009 Restructuring Amounts”); charges related to the loss accruals or awards for legal settlements (the “2009 Legal Accruals”); the Non-Cash Interest Expense; the income tax benefit (expense) recognized as the result of resolving certain non-routine transfer pricing issues with the Internal Revenue Service for prior periods (the “Income Tax Benefit (Expense)”); the tax benefit principally related to certain prior period charges excluded from adjusted earnings (the “Prior Period Charges Tax Benefit”) and, for the nine months ended September 30, 2009, the net tax benefit resulting from adjustments to previously established deferred taxes, primarily related to prior acquisitions and stock option expense, due to changes in California tax law effective for future periods (the “State Tax Adjustment”). For the three and nine months ended September 30, 2009, the Company’s adjustments to GAAP financial measures also include the tax effect of the adjustments in 2009, discussed below, excluding the Income Tax Benefit (Expense), the Prior Period Charges Tax Benefit, and, for the nine months ended September 30, 2009, the State Tax Adjustment (the “2009 Tax Effect”).
For the three and nine months ended September 30, 2009, the Company reported non-GAAP financial results for COS expense, R&D expense, SG&A expense, Interest expense, net and weighted average shares used in the calculation of adjusted diluted earnings per share. COS expense, R&D expense and SG&A expense were adjusted to exclude the effects of expensing stock options. R&D expense and SG&A expense and, for the nine months ended September 30, 2009, COS expense were also adjusted to exclude the 2009 Restructuring Amounts. R&D expense was also adjusted to exclude the R&D Technology Intangible Assets’ Amortization. Interest expense, net was adjusted to exclude the Non-Cash Interest Expense. Weighted average shares used in the calculation of adjusted diluted earnings per share were adjusted to exclude the related effects of expensing stock options. The Company believes that excluding the impact of expensing stock options and the related effects of expensing stock options provide supplemental measures that will facilitate comparisons between periods before and during when such expenses are incurred. The Company believes that excluding the R&D Technology Intangible Assets’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that excluding the 2009 Restructuring Amounts and the Non-Cash Interest Expense provide supplemental measures that will facilitate comparisons between periods before, during and after such expenses are incurred.
3
For the three and nine months ended September 30, 2009, the Company reported non-GAAP adjusted provisions for income taxes, adjusted net income and adjusted earnings per share excluding, where applicable, the foregoing expense amounts and the related effects of expensing stock options on weighted average shares used in the calculation of adjusted diluted earnings per share for the reasons discussed above, the Immunex Intangible Assets’ Amortization, the 2009 Legal Accruals, the 2009 Restructuring Amounts, the 2009 Tax Effect, the Income Tax Benefit (Expense), the Prior Period Charges Tax Benefit, and, for the nine months ended September 30, 2009, the State Tax Adjustment. The Company believes that excluding the Immunex Intangible Assets’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that excluding the 2009 Restructuring Amounts provides a supplemental measure that will facilitate comparisons between periods before, during and after such expenses are incurred. The Company believes that excluding the 2009 Legal Accruals, the Income Tax Benefit (Expense), the Prior Period Charges Tax Benefit and the State Tax Adjustment provide supplemental measures that will facilitate comparisons between periods in which such items did not occur. The Company believes that excluding the 2009 Tax Effect provides a supplemental measure that will facilitate comparisons before, during and after the related adjustments have occurred.
The Company uses the foregoing non-GAAP financial measures in connection with its own budgeting and financial planning.
Due to the differing treatments of expensing stock options for the purpose of presenting adjusted earnings per share within and across industries, the Company also reported non-GAAP adjusted earnings per share including the impact of expensing stock options for the three and nine months ended September 30, 2010 and 2009, as a convenience to investors.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
| 99.1 | Press Release dated October 25, 2010 |
4
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMGEN INC. | ||||
| Date: October 25, 2010 | By: | /s/ Jonathan M. Peacock | ||
| Name: | Jonathan M. Peacock | |||
| Title: | Executive Vice President and Chief Financial Officer | |||
5
EXHIBIT INDEX
| Exhibit Number |
Document Description | |
| 99.1 | Press release dated October 25, 2010 | |
6
EXHIBIT 99.1
|
||||
| One Amgen Center Drive Thousand Oaks, CA 91320-1799 Telephone (805) 447-1000 Fax (805) 499-3507 www.amgen.com | ||||
|
News Release |
||||
AMGEN’S THIRD QUARTER 2010 REVENUE
UNCHANGED AT $3.8 BILLION VERSUS PRIOR YEAR
Third Quarter 2010 Adjusted Earnings Per Share Decreased 9
Percent to $1.36
Third Quarter 2010 GAAP Earnings Per Share Decreased 6
Percent to $1.28
2010 Revenue and Adjusted EPS Guidance Reaffirmed
THOUSAND OAKS, Calif. (Oct. 25, 2010) – Amgen (NASDAQ: AMGN) reported revenue unchanged for the third quarter of 2010 at $3,816 million versus $3,812 million for the third quarter of 2009.
Adjusted net income decreased 14 percent to $1,313 million for the third quarter of 2010 compared to $1,518 million for the third quarter of 2009. The decrease in adjusted net income was driven by unusually low research and development (R&D) costs and favorable tax settlements in the third quarter of 2009. Adjusted earnings per share (EPS) were $1.36 for the third quarter of 2010, a decrease of 9 percent compared to $1.49 for the third quarter of 2009.
“We are pleased with our progress this year and look forward to resuming growth,” said Kevin Sharer, chairman & chief executive officer.
Adjusted EPS and adjusted net income for the third quarter of 2010 and 2009 exclude, for the applicable periods, stock option expense, certain expenses related to acquisitions, non-cash interest expense resulting from a change in accounting for our convertible notes, the income tax benefit (expense) as a result of resolving certain non-routine transfer pricing issues with tax authorities, and certain other items. These adjustments and other items are presented on the attached reconciliation tables.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 2
On a reported basis and calculated in accordance with United States (U.S.) Generally Accepted Accounting Principles (GAAP), Amgen’s GAAP diluted EPS were $1.28 for the third quarter of 2010, reflecting a decrease of 6 percent from the third quarter of 2009. GAAP net income decreased 11 percent to $1,236 million for the third quarter of 2010 from $1,386 million for the third quarter of 2009.
Product Sales Performance
Total product sales for the third quarter of 2010 increased 1 percent to $3,759 million from $3,736 million for the third quarter of 2009. Sales in the U.S. were $2,921 million in the third quarter of 2010 versus $2,918 million for the third quarter of 2009. Third quarter 2010 U.S. product sales included a $64 million unfavorable impact due to U.S. Health Care Reform. International sales increased 2 percent to $838 million versus $818 million for the third quarter of 2009. Changes in foreign exchange negatively impacted third quarter 2010 sales by $16 million. Excluding the unfavorable impact of foreign exchange, international product sales increased 4 percent.
Worldwide sales of Aranesp® (darbepoetin alfa) decreased 9 percent to $623 million in the third quarter of 2010 versus $685 million for the third quarter of 2009. In the U.S., Aranesp sales decreased 15 percent to $283 million for the third quarter of 2010 versus $333 million for the third quarter of 2009. The decrease was principally due to a low double-digit percentage point decline in unit demand reflecting an overall decline in the segment, slightly offset by an increase in the average net sales price, and unfavorable changes in wholesaler inventories. International Aranesp sales decreased 3 percent to $340 million versus $352 million in the third quarter of 2009 due to the unfavorable impact of foreign exchange and a decrease in demand, reflecting an overall decline in the segment. Excluding the unfavorable impact of foreign exchange of $7 million, worldwide Aranesp sales decreased 8 percent and international product sales decreased 1 percent.
Sales of EPOGEN® (Epoetin alfa) decreased 2 percent to $653 million in the third quarter of 2010 versus $663 million in the third quarter of 2009 primarily due to a low single-digit percentage point decline in both unit demand and the average net sales price, partially offset by favorable changes in wholesaler inventory. The decrease in unit demand reflects a decrease in dose utilization, partially offset by patient population growth.
Combined worldwide sales of Neulasta® (pegfilgrastim) and NEUPOGEN® (Filgrastim) increased 4 percent to $1,254 million in the third quarter of 2010 versus $1,210 million for the third quarter of 2009. Combined sales of Neulasta and NEUPOGEN in the U.S. were $942 million in the third quarter of 2010 versus $897 million in the third quarter of 2009, an increase of 5 percent due primarily to
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 3
an increase in the average net sales price. Combined international sales were $312 million in the third quarter of 2010 versus $313 million for the third quarter of 2009. Excluding the $6 million unfavorable impact of foreign exchange, international product sales increased 2 percent, reflecting continued conversion from NEUPOGEN to Neulasta.
Sales of Enbrel® (etanercept) decreased 1 percent in the third quarter of 2010 to $914 million versus $924 million for the third quarter of 2009 due to share declines primarily in dermatology, partially offset by a slight increase in the average net sales price. ENBREL continues to maintain a leading position in both the rheumatology and dermatology segments.
Worldwide sales of Sensipar® (cinacalcet) increased 6 percent to $175 million in the third quarter of 2010 versus $165 million during the third quarter of 2009, primarily as a result of increased international demand.
Vectibix® (panitumumab) sales increased 21 percent to $70 million in the third quarter of 2010 versus $58 million for the third quarter of 2009 driven by an increase in demand in the U.S. and internationally.
Nplate® (romiplostim) sales increased 94 percent to $60 million in the third quarter of 2010 versus $31 million for the third quarter of 2009 driven by an increase in demand in the U.S. and internationally.
ProliaTM (denosumab) sales for the quarter were $10 million, reflecting steady progress with physicians, patients and payers in the U.S. and internationally.
Operating Expense Analysis on an Adjusted Basis:
Cost of sales increased to 15.5 percent of sales for the third quarter of 2010 versus 14.5 percent of sales for the third quarter of 2009. This increase was primarily driven by higher inventory write-offs due to the EPOGEN and Procrit® (Epoetin alfa) product recalls and higher bulk material cost, partially offset by lower excess capacity charges.
R&D expenses increased 12 percent to $689 million for the third quarter of 2010 versus $613 million for the third quarter of 2009. This increase was primarily driven by higher cost recoveries in the third quarter of 2009 and higher staff related costs primarily from increased headcount outside the U.S. in the third quarter of 2010.
Selling, General, and Administrative (SG&A) expenses increased 3 percent to $942 million in the third quarter of 2010 versus $913 million in the third quarter of 2009. This increase was primarily due to higher staff related and promotional activities for Prolia and other marketed products, as well as higher litigation expenses.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 4
Excluding expenses associated with the Pfizer profit share of $302 million and $306 million for the third quarter of 2010 and 2009, respectively, adjusted SG&A expenses for the third quarter of 2010 increased 5 percent versus the third quarter of 2009.
The adjusted tax rate for the third quarter of 2010 was 19.1 percent compared to 12.9 percent for the third quarter of 2009. The increase was primarily due to the 2009 favorable impact of settling federal and state income tax audits, as well as the benefit of the federal R&D credit in third quarter of 2009.
During the third quarter of 2010, the Company repurchased approximately 6.6 million shares of common stock at a total cost of $0.4 billion. The Company currently has $3.3 billion remaining under its authorized stock repurchase program.
Average diluted shares for adjusted EPS for the third quarter of 2010 were 962 million versus 1,021 million for the third quarter of 2009.
Capital expenditures for the third quarter of 2010 were $127 million versus $130 million for the third quarter of 2009. Worldwide cash and marketable securities were $17.0 billion and adjusted outstanding debt was $13.7 billion as of Sept. 30, 2010. The Company’s adjusted outstanding debt excludes the impact of a change in accounting on the carrying values of its convertible notes. The Company’s outstanding debt presented in accordance with GAAP was $13.3 billion as of Sept. 30, 2010.
2010 Guidance Update
The Company reaffirmed both revenue and adjusted EPS guidance at slightly below $15.1 billion and towards lower end of $5.05 to $5.25, respectively.
Included in the 2010 revenue and Adjusted EPS guidance noted above is the estimated impact of the U.S. Health Care Reform Legislation of slightly below $200 million.
The Company now expects the 2010 adjusted tax rate to be around 20 percent and continues to expect capital expenditures to be approximately $600 million.
Adjusted EPS and the adjusted tax rate exclude stock option expense, certain expenses related to prior acquisitions, the non-cash interest expense resulting from a change in accounting for our convertible notes, and the income tax benefit as a result of resolving certain non-routine transfer pricing issues with tax authorities.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 5
Third Quarter Product and Pipeline Update
The Company provided updates on selected products and clinical programs.
Aranesp: The Company discussed the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) panel meeting which took place on Oct. 18th, 2010. The purpose of the panel was to review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy), conducted in patients not on dialysis, and how those results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) in patients with chronic kidney disease (CKD). The Company will continue to work with the FDA to develop information that will optimize the use of ESAs in CKD patients.
Denosumab: The Company reaffirmed that the Prescription Drug User Fee Act (PDUFA) action date for its application for denosumab for the treatment of bone metastases to reduce skeletal related events in patients with cancer is Thursday, Nov. 18, 2010. The FDA granted priority review designation to denosumab for this indication. Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
The Company reaffirmed that data from study ‘147 for denosumab in the prevention of prostate cancer bone metastases is expected to be available in the fourth quarter of 2010.
Vectibix: The Company announced that it plans to file supplemental Biologics License Applications for first-and second-line metastatic colorectal cancer indications in the U.S. during the fourth quarter of 2010.
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, 2010 and 2009. In addition, management has presented its outstanding debt in accordance with GAAP and on an “adjusted” (or non-GAAP basis) as of Sept. 30, 2010. 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 GAAP. Further, our reconciliations of GAAP to “adjusted” operating results, which are included on the attached tables, are presented in a format which we believe facilitates a reader’s understanding of the impact of the various adjustments to our GAAP operating results, individually and in the aggregate, and are not intended to place any undue prominence on our adjusted operating results.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 6
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 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, 2009, 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
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 7
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.
| CONTACT: | Amgen, Thousand Oaks David Polk, 805-447-4613 (media) Arvind Sood, 805-447-1060 (investors) |
###
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 8
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, 2010 | September 30, 2009 | |||||||||||||||||||||||
| GAAP | Adjustments | “Adjusted” | GAAP | Adjustments | “Adjusted” | |||||||||||||||||||
| Revenues: |
||||||||||||||||||||||||
| Product sales |
$ | 3,759 | $ | — | $ | 3,759 | $ | 3,736 | $ | — | $ | 3,736 | ||||||||||||
| Other revenues |
57 | — | 57 | 76 | — | 76 | ||||||||||||||||||
| Total revenues |
3,816 | — | 3,816 | 3,812 | — | 3,812 | ||||||||||||||||||
| Operating expenses: |
||||||||||||||||||||||||
| Cost of sales (excludes amortization of certain acquired intangible assets presented below) |
587 | (3 | )(a) | 584 | 545 | (3 | )(a) | 542 | ||||||||||||||||
| Research and development |
719 | (12 | )(a) | 689 | 647 | (13 | )(a) | 613 | ||||||||||||||||
| (18 | )(b) | (18 | )(b) | |||||||||||||||||||||
| (3 | )(f) | |||||||||||||||||||||||
| Selling, general and administrative |
957 | (15 | )(a) | 942 | 932 | (13 | )(a) | 913 | ||||||||||||||||
| (6 | )(f) | |||||||||||||||||||||||
| Amortization of certain acquired intangible assets |
74 | (74 | )(c) | — | 74 | (74 | )(c) | — | ||||||||||||||||
| Other |
— | — | — | 9 | (8 | )(e) | — | |||||||||||||||||
| (1 | )(f) | |||||||||||||||||||||||
| Total operating expenses |
2,337 | (122 | ) | 2,215 | 2,207 | (139 | ) | 2,068 | ||||||||||||||||
| Operating income |
1,479 | 122 | 1,601 | 1,605 | 139 | 1,744 | ||||||||||||||||||
| Interest expense, net |
150 | (67 | )(d) | 83 | 139 | (63 | )(d) | 76 | ||||||||||||||||
| Interest and other income, net |
105 | — | 105 | 74 | — | 74 | ||||||||||||||||||
| Income before income taxes |
1,434 | 189 | 1,623 | 1,540 | 202 | 1,742 | ||||||||||||||||||
| Provision for income taxes |
198 | 74 | (g) | 310 | 154 | 80 | (h) | 224 | ||||||||||||||||
| 38 | (i) | (28 | )(i) | |||||||||||||||||||||
| 18 | (k) | |||||||||||||||||||||||
| Net income |
$ | 1,236 | $ | 77 | $ | 1,313 | $ | 1,386 | $ | 132 | $ | 1,518 | ||||||||||||
| Earnings per share: |
||||||||||||||||||||||||
| Basic |
$ | 1.29 | $ | 1.37 | $ | 1.36 | $ | 1.49 | ||||||||||||||||
| Diluted (l) |
$ | 1.28 | $ | 1.36 | (a) | $ | 1.36 | $ | 1.49 | (a) | ||||||||||||||
| Average shares used in calculation of earnings per share: |
||||||||||||||||||||||||
| Basic |
958 | 958 | 1,016 | 1,016 | ||||||||||||||||||||
| Diluted (l) |
962 | 962 | (a) | 1,022 | 1,021 | (a) | ||||||||||||||||||
(a) - (l) See explanatory notes on the following pages.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 9
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, 2010 | September 30, 2009 | |||||||||||||||||||||||
| GAAP | Adjustments | “Adjusted” | GAAP | Adjustments | “Adjusted” | |||||||||||||||||||
| Revenues: |
||||||||||||||||||||||||
| Product sales |
$ | 10,900 | $ | — | $ | 10,900 | $ | 10,608 | $ | — | $ | 10,608 | ||||||||||||
| Other revenues |
312 | — | 312 | 225 | — | 225 | ||||||||||||||||||
| Total revenues |
11,212 | — | 11,212 | 10,833 | — | 10,833 | ||||||||||||||||||
| Cost of sales (excludes amortization of certain acquired intangible assets presented below) |
1,648 | (11 | )(a) | 1,637 | 1,553 | (9 | )(a) | 1,543 | ||||||||||||||||
| (1 | )(f) | |||||||||||||||||||||||
| Research and development |
2,040 | (40 | )(a) | 1,948 | 1,973 | (40 | )(a) | 1,875 | ||||||||||||||||
| (52 | )(b) | (52 | )(b) | |||||||||||||||||||||
| (6 | )(f) | |||||||||||||||||||||||
| Selling, general and administrative |
2,827 | (44 | )(a) | 2,783 | 2,640 | (39 | )(a) | 2,578 | ||||||||||||||||
| (23 | )(f) | |||||||||||||||||||||||
| Amortization of certain acquired intangible assets |
221 | (221 | )(c) | — | 221 | (221 | )(c) | — | ||||||||||||||||
| Other |
(1 | ) | 1 | (e) | — | 63 | (28 | )(e) | — | |||||||||||||||
| (35 | )(f) | |||||||||||||||||||||||
| Total operating expenses |
6,735 | (367 | ) | 6,368 | 6,450 | (454 | ) | 5,996 | ||||||||||||||||
| Operating income |
4,477 | 367 | 4,844 | 4,383 | 454 | 4,837 | ||||||||||||||||||
| Interest expense, net |
442 | (198 | )(d) | 244 | 436 | (186 | )(d) | 250 | ||||||||||||||||
| Interest and other income, net |
283 | — | 283 | 182 | — | 182 | ||||||||||||||||||
| Income before income taxes |
4,318 | 565 | 4,883 | 4,129 | 640 | 4,769 | ||||||||||||||||||
| Provision for income taxes |
713 | 211 | (g) | 962 | 455 | 235 | (h) | 820 | ||||||||||||||||
| 38 | (i) | 87 | (i) | |||||||||||||||||||||
| 25 | (j) | |||||||||||||||||||||||
| 18 | (k) | |||||||||||||||||||||||
| Net income |
$ | 3,605 | $ | 316 | $ | 3,921 | $ | 3,674 | $ | 275 | $ | 3,949 | ||||||||||||
| Earnings per share: |
||||||||||||||||||||||||
| Basic |
$ | 3.73 | $ | 4.06 | $ | 3.60 | $ | 3.87 | ||||||||||||||||
| Diluted (l) |
$ | 3.71 | $ | 4.04 | (a) | $ | 3.58 | $ | 3.86 | (a) | ||||||||||||||
| Average shares used in calculation of earnings per share: |
||||||||||||||||||||||||
| Basic |
966 | 966 | 1,020 | 1,020 | ||||||||||||||||||||
| Diluted (l) |
971 | 971 | (a) | 1,025 | 1,024 | (a) | ||||||||||||||||||
(a) - (l) See explanatory notes on the following pages.
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 10
Amgen Inc.
Notes to Reconciliation of GAAP Earnings to “Adjusted” Earnings
(In millions, except per share data)
(Unaudited)
| (a) | To exclude stock option expense. For the three and nine months ended September 30, 2010 and 2009, the total pre-tax expense for employee stock options was $30 million and $95 million, respectively, and $29 million and $88 million, respectively. |
“Adjusted” diluted EPS including the impact of stock option expense for the three and nine months ended September 30, 2010 and 2009 was as follows:
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| “Adjusted” diluted EPS, excluding stock option expense |
$ | 1.36 | $ | 1.49 | $ | 4.04 | $ | 3.86 | ||||||||
| Impact of stock option expense (net of tax) |
(0.01 | ) | (0.02 | ) | (0.07 | ) | (0.06 | ) | ||||||||
| “Adjusted” diluted EPS, including stock option expense |
$ | 1.35 | $ | 1.47 | $ | 3.97 | $ | 3.80 | ||||||||
| (b) | To exclude the ongoing, non-cash amortization of the R&D technology intangible assets with alternative future uses acquired with the acquisitions of Abgenix, Inc. (“Abgenix”) and Avidia, Inc. (“Avidia”). |
| (c) | To exclude the ongoing, non-cash amortization of acquired product technology rights, primarily ENBREL, related to the Immunex Corporation (“Immunex”) acquisition. |
| (d) | To exclude the incremental non-cash interest expense resulting from a change in the accounting for our convertible notes effective January 1, 2009. |
| (e) | To exclude loss accruals or awards for legal settlements. |
| (f) | To exclude the expenses associated with our restructuring plan announced in August 2007 and certain additional cost savings initiatives subsequently identified. |
| (g) | To reflect the tax effect of the above adjustments for 2010. |
| (h) | To reflect the tax effect of the above adjustments for 2009. |
| (i) | To exclude the income tax benefit (expense) recognized as a result of resolving certain non-routine transfer pricing issues with tax authorities for prior periods. |
| (j) | To exclude the net tax benefit resulting from adjustments to previously established deferred taxes, primarily related to prior acquisitions and stock option expense, due to changes in California tax law effective for future periods. |
| (k) | To exclude the tax benefit principally related to certain prior period charges excluded from “Adjusted” earnings. |
| (l) | 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, 2010 | September 30, 2009 | |||||||||||||||
| GAAP | “Adjusted” | GAAP | “Adjusted” | |||||||||||||
| Income (Numerator): |
||||||||||||||||
| Net income for basic and diluted EPS |
$ | 1,236 | $ | 1,313 | $ | 1,386 | $ | 1,518 | ||||||||
| Shares (Denominator): |
||||||||||||||||
| Weighted-average shares for basic EPS |
958 | 958 | 1,016 | 1,016 | ||||||||||||
| Effect of dilutive securities |
4 | 4 | (*) | 6 | 5 | (*) | ||||||||||
| Weighted-average shares for diluted EPS |
962 | 962 | 1,022 | 1,021 | ||||||||||||
| Diluted earnings per share |
$ | 1.28 | $ | 1.36 | $ | 1.36 | $ | 1.49 | ||||||||
| Nine months ended | Nine months ended | |||||||||||||||
| September 30, 2010 | September 30, 2009 | |||||||||||||||
| GAAP | “Adjusted” | GAAP | “Adjusted” | |||||||||||||
| Income (Numerator): |
||||||||||||||||
| Net income for basic and diluted EPS |
$ | 3,605 | $ | 3,921 | $ | 3,674 | $ | 3,949 | ||||||||
| Shares (Denominator): |
||||||||||||||||
| Weighted-average shares for basic EPS |
966 | 966 | 1,020 | 1,020 | ||||||||||||
| Effect of dilutive securities |
5 | 5 | (*) | 5 | 4 | (*) | ||||||||||
| Weighted-average shares for diluted EPS |
971 | 971 | 1,025 | 1,024 | ||||||||||||
| Diluted earnings per share |
$ | 3.71 | $ | 4.04 | $ | 3.58 | $ | 3.86 | ||||||||
| (*) | Dilutive securities used to compute “Adjusted” diluted earnings per share for the three and nine months ended September 30, 2010 and 2009 were computed under the treasury stock method assuming that we do not expense stock options. |
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 11
Amgen Inc.
Product Sales Detail by Product and Geographic Region
(In millions)
(Unaudited)
| Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
|
Aranesp® - U.S. |
$ | 283 | $ | 333 | $ | 818 | $ | 963 | ||||||||
|
Aranesp® - International |
340 | 352 | 1,035 | 1,041 | ||||||||||||
|
EPOGEN® - U.S. |
653 | 663 | 1,933 | 1,866 | ||||||||||||
|
Neulasta® - - U.S. |
692 | 657 | 1,972 | 1,876 | ||||||||||||
|
NEUPOGEN® - - U.S. |
250 | 240 | 700 | 672 | ||||||||||||
|
Neulasta® - - International |
224 | 214 | 668 | 603 | ||||||||||||
|
NEUPOGEN® - - International |
88 | 99 | 267 | 290 | ||||||||||||
|
Enbrel® - U.S. |
856 | 872 | 2,429 | 2,430 | ||||||||||||
|
Enbrel® - Canada |
58 | 52 | 166 | 151 | ||||||||||||
|
Sensipar® - - U.S. |
115 | 108 | 344 | 320 | ||||||||||||
|
Sensipar® - - International |
60 | 57 | 182 | 160 | ||||||||||||
|
Vectibix® - - U.S. |
30 | 23 | 84 | 72 | ||||||||||||
|
Vectibix® - - International |
40 | 35 | 125 | 95 | ||||||||||||
|
Nplate® - U.S. |
35 | 22 | 95 | 54 | ||||||||||||
|
Nplate® - International |
25 | 9 | 69 | 15 | ||||||||||||
| Prolia™ - U.S. |
7 | — | 10 | — | ||||||||||||
|
Prolia® - International |
3 | — | 3 | — | ||||||||||||
| Total product sales |
$ | 3,759 | $ | 3,736 | $ | 10,900 | $ | 10,608 | ||||||||
| U.S. |
$ | 2,921 | $ | 2,918 | $ | 8,385 | $ | 8,253 | ||||||||
| International |
838 | 818 | 2,515 | 2,355 | ||||||||||||
| Total product sales |
$ | 3,759 | $ | 3,736 | $ | 10,900 | $ | 10,608 | ||||||||
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 12
Amgen Inc.
Condensed Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
| September 30, 2010 |
December 31, 2009 |
|||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash, cash equivalents and marketable securities |
$ | 17,049 | $ | 13,442 | ||||
| Trade receivables, net |
2,443 | 2,109 | ||||||
| Inventories |
2,044 | 2,220 | ||||||
| Other current assets |
1,394 | 1,161 | ||||||
| Total current assets |
22,930 | 18,932 | ||||||
| Property, plant and equipment, net |
5,643 | 5,738 | ||||||
| Intangible assets, net |
2,315 | 2,567 | ||||||
| Goodwill |
11,334 | 11,335 | ||||||
| Other assets |
1,312 | 1,057 | ||||||
| Total assets |
$ | 43,534 | $ | 39,629 | ||||
| Liabilities and Stockholders’ Equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable and accrued liabilities |
$ | 3,809 | $ | 3,873 | ||||
| Current portion of convertible notes |
2,451 | — | ||||||
| Total current liabilities |
6,260 | 3,873 | ||||||
| Convertible notes |
2,263 | 4,512 | ||||||
| Other long-term debt |
8,578 | 6,089 | ||||||
| Other non-current liabilities |
2,362 | 2,488 | ||||||
| Stockholders’ equity |
24,071 | 22,667 | ||||||
| Total liabilities and stockholders’ equity |
$ | 43,534 | $ | 39,629 | ||||
| Shares outstanding |
952 | 995 | ||||||
Amgen Inc.
Reconciliation of GAAP Debt Outstanding to “Adjusted” Debt Outstanding
(In millions)
(Unaudited)
| September 30, 2010 | ||||||||||||
| GAAP | Adjustments for accounting standard |
“Adjusted” | ||||||||||
| Total debt outstanding |
$ | 13,292 | $ | 368 | (a) | $ | 13,660 | |||||
| (a) | To exclude the impact of adopting an accounting standard on January 1, 2009 that changed the method of accounting for our convertible notes. |
- MORE -
Amgen’s Third Quarter Revenue Unchanged at $3.8 Billion;
Third Quarter Adjusted EPS Decreased 9 Percent to $1.36
Page 13
Amgen Inc.
Reconciliation of GAAP Earnings Per Share Guidance to “Adjusted”
Earnings Per Share Guidance for the Year Ending December 31, 2010
(Unaudited)
On October 25, 2010, the Company reaffirmed its “Adjusted” earnings per share guidance towards lower end of $5.05 to $5.25, including the estimated impact of the U.S. Health Care Reform Legislation of slightly below $200 million. The following table shows a reconciliation of GAAP earnings per share (diluted) guidance to “Adjusted” earnings per share (diluted) guidance.
| 2010 | ||||
| GAAP earnings per share (diluted) guidance |
$4.59 - $4.80 | |||
| Known adjustments to arrive at “Adjusted” earnings*: |
||||
| Amortization of acquired intangible assets, product technology rights (a) |
0.19 | |||
| Incremental non-cash interest expense (b) |
0.17 | |||
| Stock option expense (c) |
0.08 - 0.09 | |||
| Amortization of acquired intangible assets, R&D technology rights (d) |
0.05 | |||
| Tax settlement (e) |
(0.04 | ) | ||
| “Adjusted” earnings per share (diluted) guidance |
$5.05 - $5.25 | |||
| * | The known adjustments are presented, where applicable, net of their related aggregate tax impact of approximately $0.28 to $0.29 per share. |
| (a) | To exclude the ongoing, non-cash amortization of acquired product technology rights, primarily ENBREL, related to the Immunex acquisition. |
| (b) | To exclude the incremental non-cash interest expense resulting from a change in accounting in January 2009 related to our convertible debt. |
| (c) | To exclude stock option expense. |
| (d) | To exclude the ongoing, non-cash amortization of the R&D technology intangible assets acquired with the Abgenix and Avidia acquisitions. |
| (e) | To exclude the income tax benefit recognized as a result of resolving certain non-routine transfer pricing issues with tax authorities for prior periods. |
Amgen Inc.
Reconciliation of GAAP Tax Rate Guidance to “Adjusted”
Tax Rate Guidance for the Year Ending December 31, 2010
(Unaudited)
On October 25, 2010, the Company stated that it now expects its “Adjusted” tax rate guidance to be around 20%. The tax rate effect of known adjustments discussed above is approximately 3%, resulting in GAAP tax rate guidance of approximately 17%.