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)
July 29, 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 July 29, 2010, Amgen Inc. (the “Company”) issued a press release announcing its unaudited results of operations and financial condition for the three and six months ended June 30, 2010 and as of June 30, 2010, respectively. 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 June 30, 2010 and for the three and six months ended June 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 June 30, 2010
As of June 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 six months ended June 30, 2010
For the three and six months ended June 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”); and, for the six months ended June 30, 2010, the net benefit arising from settlements of certain legal proceedings (the “2010 Legal Accruals”). For the three and six months ended June 30, 2010, the Company’s adjustments to GAAP financial measures also include the tax effect of the adjustments in 2010, discussed below (the “2010 Tax Effect”).
For the three and six months ended June 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 diluted shares used in the calculation of adjusted 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. Diluted shares used in the calculation of adjusted 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 Non-Cash Interest Expense provides a supplemental measure that will facilitate comparisons before, during and after such expense is incurred.
2
For the three and six months ended June 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 diluted shares used in the calculation of adjusted 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 and, for the six months ended June 30, 2010, the 2010 Legal Accruals. 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 Accruals provides a supplemental measure that will facilitate comparisons between periods in which such item 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 six months ended June 30, 2009
For the three and six months ended June 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 for certain legal settlements (the “2009 Legal Accruals”); 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 six months ended June 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 six months ended June 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 and the State Tax Adjustment (the “2009 Tax Effect”).
For the three and six months ended June 30, 2009, the Company reported non-GAAP financial results for COS expense, R&D expense, SG&A expense, Interest expense, net and diluted shares used in the calculation of adjusted earnings per share. COS expense, R&D expense and SG&A expense were adjusted to exclude the effects of expensing stock options and 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. Diluted shares used in the calculation of adjusted 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.
For the three and six months ended June 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 diluted shares used in the calculation of adjusted earnings per share for the reasons discussed above, the Immunex Intangible Assets’ Amortization, the 2009 Restructuring Amounts, the 2009 Legal Accruals, the Income Tax Benefit, the 2009 Tax Effect, and, for the six months ended June 30, 2009, the State Tax Adjustment. The Company believes that excluding the Immunex Intangible Assets’ Amortization treats those assets as if
3
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 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 six months ended June 30, 2010 and 2009, as a convenience to investors.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
| 99.1 | Press Release dated July 29, 2010 |
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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: July 29, 2010 | By: | /s/ Michael A. Kelly | ||
| Name: | Michael A. Kelly | |||
| Title: | Acting Chief Financial Officer | |||
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EXHIBIT INDEX
| Exhibit |
Document Description | |
| 99.1 | Press release dated July 29, 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 SECOND QUARTER 2010 ADJUSTED EARNINGS
PER SHARE INCREASED 7 PERCENT TO $1.38
Second Quarter 2010 Revenue
Increased 2 Percent to $3.8 Billion
Second Quarter 2010 GAAP Earnings Per Share
Unchanged at $1.25
Adjusting for the Impact of a Weaker Euro, 2010 Total Revenue
Guidance Revised to Slightly Below $15.1 Billion
2010 Adjusted Earnings Per Share Guidance Unchanged at
Towards Lower End of $5.05–$5.25
THOUSAND OAKS, Calif. (July 29, 2010) – Amgen (NASDAQ: AMGN) reported adjusted earnings per share (EPS) of $1.38 for the second quarter of 2010, an increase of 7 percent compared to $1.29 for the second quarter of 2009. Adjusted net income increased 1 percent to $1,326 million for the second quarter of 2010 compared to $1,311 million for the second quarter of 2009.
Total revenue increased 2 percent for the second quarter of 2010 to $3,804 million versus $3,713 million for the second quarter of 2009.
“We delivered a solid quarter,” said Kevin Sharer, chairman & CEO. “We are in the process of launching Prolia worldwide and look forward to working with global regulatory authorities to gain approval for denosumab in patients with advanced cancer.”
Adjusted EPS and adjusted net income for the second quarter of 2010 and 2009 exclude, for the applicable periods, stock option expense, certain expenses
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 2
related to acquisitions, non-cash interest expense resulting from a change in accounting in the first quarter of 2009 for our convertible notes, the income tax benefit as a result of resolving certain non-routine transfer pricing issues with the Internal Revenue Service (“IRS”) and certain other items. These adjustments and other items are presented on the attached reconciliation tables.
On a reported basis and calculated in accordance with United States (U.S.) Generally Accepted Accounting Principles (GAAP), Amgen’s GAAP diluted EPS were $1.25 for the second quarter of 2010, unchanged from the second quarter of 2009. GAAP net income decreased 5 percent to $1,202 million for the second quarter of 2010 from $1,269 million for the second quarter of 2009. GAAP net income for the second quarter of 2009 was positively impacted by $115 million as a result of resolving certain non-routine transfer pricing issues with the IRS.
Product Sales Performance
Total product sales for the second quarter of 2010 decreased 1 percent to $3,613 million from $3,634 million for the second quarter of 2009. Sales in the U.S. totaled $2,787 million, a decrease of 2 percent versus $2,833 million for the second quarter of 2009. Second quarter 2010 U.S. product sales include a $45 million unfavorable impact for certain U.S. Health Care Reform Legislation provisions that were in effect during the second quarter, partially offset by a $9 million favorable adjustment related to changes in accounting estimates with respect to the accruals for U.S. Health Care Reform Legislation recorded in the first quarter of 2010. International sales increased 3 percent to $826 million versus $801 million for the second quarter of 2009. Changes in foreign exchange positively impacted second quarter 2010 sales by $11 million. Excluding the favorable impact of foreign exchange, total product sales decreased 1 percent and international product sales increased 2 percent.
Worldwide sales of Aranesp® (darbepoetin alfa) decreased 13 percent to $603 million in the second quarter of 2010 versus $693 million for the second quarter of 2009. In the U.S., Aranesp sales decreased 21 percent to $267 million for the second quarter of 2010 versus $338 million for the second quarter of 2009. The decrease was driven by a decline in demand. The decline in demand was due to a decrease in units sold reflecting an overall decline in the segment, and to a lesser extent, a slight loss of segment share. International Aranesp sales decreased 5 percent to $336 million versus $355 million in the second quarter of 2009 due to a decrease in demand reflecting an overall decline in the segment. Excluding the favorable impact of foreign exchange of $3 million, worldwide Aranesp sales decreased 13 percent and international product sales decreased 6 percent.
Sales of EPOGEN® (Epoetin alfa) increased 3 percent to $657 million in the second quarter of 2010 versus $638 million in the second quarter of 2009, primarily due to an increase in demand and favorable changes in wholesaler inventories. The increase in demand was principally due to patient population growth, partially offset by a decrease in dose utilization.
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 3
Combined worldwide sales of Neulasta® (pegfilgrastim) and NEUPOGEN® (Filgrastim) increased 1 percent to $1,174 million in the second quarter of 2010 versus $1,158 million for the second quarter of 2009. Combined sales of Neulasta and NEUPOGEN in the U.S. were $868 million in the second quarter of 2010 versus $855 million in the second quarter of 2009, an increase of 2 percent due primarily to favorable changes in wholesaler inventories, partially offset by a low single-digit percentage point decrease in demand. The decrease in demand was driven by a decline in units sold, partially offset by a mid single-digit percentage point increase in average net sales price. Combined international sales increased 1 percent to $306 million in the second quarter of 2010 versus $303 million for the second quarter of 2009. This increase was primarily driven by the positive impact of changes in foreign exchange of $5 million. This increase was partially offset by a slight decrease in demand. Excluding the impact of foreign exchange, combined worldwide product sales of NEUPOGEN and Neulasta increased 1 percent and international product sales decreased 1 percent.
Sales of Enbrel® (etanercept) decreased 2 percent in the second quarter of 2010 to $877 million versus $899 million for the second quarter of 2009, driven by a decrease in demand. The decrease in demand was principally due to a mid single-digit percentage point decline in units sold reflecting a share decline primarily as a result of increased competitive activity in dermatology, partially offset by an increase in average net sales price. ENBREL continues to maintain a leading position in both the rheumatology and dermatology segments.
Worldwide sales of Sensipar® (cinacalcet) increased 3 percent to $172 million in the second quarter of 2010 versus $167 million during the second quarter of 2009, primarily as a result of increased demand, partially offset by unfavorable changes in U.S. wholesaler inventories.
Vectibix® (panitumumab) sales for the second quarter of 2010 were $72 million compared to $56 million for the second quarter of 2009. Sales growth was driven by international demand partially as a result of recent launches.
Operating Expense Analysis on an Adjusted Basis:
Cost of sales increased to 15.2 percent of sales for the second quarter of 2010 versus 14.5 percent of sales for the second quarter of 2009. This increase was primarily driven by higher bulk material cost and less favorable product mix, partially offset by lower royalties and excess capacity charges.
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 4
Research and Development (R&D) expenses decreased 2 percent to $642 million for the second quarter of 2010 versus $657 million for the second quarter of 2009. This decrease was primarily driven by the $50 million payment to obtain an exclusive license to Cytokinetics’ cardiac contractility program in the second quarter of 2009 partially offset by lower expense recoveries associated with ongoing collaborations and higher staff related costs.
Selling, General, and Administrative (SG&A) expenses increased 9 percent to $968 million in the second quarter of 2010 versus $891 million in the second quarter of 2009. This increase was primarily due to spending for activities in anticipation of the approval of ProliaTM (denosumab), higher litigation expenses, and higher staff related costs. These increases were partially offset by lower expenses associated with the Pfizer profit share due to lower ENBREL sales, expense recoveries related to the GlaxoSmithKline collaboration to commercialize Prolia in postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand, and Mexico, and lower promotional expenses on marketed products.
Excluding expenses associated with the Pfizer profit share of $294 million and $301 million for the second quarter of 2010 and 2009, respectively, adjusted SG&A expenses for the second quarter of 2010 increased 14 percent versus the second quarter of 2009.
The adjusted tax rate for the second quarter of 2010 was 20.0 percent compared to 18.1 percent for the second quarter of 2009. The increase was primarily due to the benefit of the federal R&D tax credit in the second quarter of 2009 (the credit has not been extended for 2010) and changes in profits associated with the Company’s Puerto Rico operations and revenue and expense mix in the second quarter of 2010 versus the second quarter of 2009.
During the second quarter of 2010, Amgen repurchased approximately 10 million shares of common stock at a total cost of $0.6 billion. The Company currently has $3.7 billion remaining under its authorized stock repurchase program.
Average diluted shares for adjusted EPS for the second quarter of 2010 were 964 million versus 1,016 million for the second quarter of 2009.
Capital expenditures for the second quarter of 2010 were $177 million versus $139 million for the second quarter of 2009. Worldwide cash and marketable securities were $14.5 billion and adjusted outstanding debt was $12.2 billion as of June 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 $11.7 billion as of June 30, 2010.
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 5
2010 Guidance Update
As a result of the weaker Euro, the Company now expects revenues to be slightly below $15.1 billion versus previous guidance towards the lower end of the range of $15.1 billion to $15.5 billion. The Company’s hedging program seeks to minimize the impact of foreign exchange volatility on net income by hedging the portion of international product sales, primarily denominated in the Euro, which are in excess of international operating expenses. As a result, changes in the Euro exchange rate do not have a material impact on net income. Adjusted EPS guidance remains unchanged at towards the lower end of the range of $5.05 to $5.25. Adjusted EPS excludes stock option expense, certain expenses related to prior acquisitions and the non-cash interest expense resulting from a change in accounting for our convertible notes.
Included in the 2010 revenue and Adjusted EPS guidance noted above is the estimated impact of the U.S. Health Care Reform Legislation of $200 million to $250 million.
The Company still expects the 2010 adjusted tax rate to be in the range of 20 percent to 21 percent and capital expenditures to be approximately $600 million.
Second Quarter Product and Pipeline Update
The Company provided updates on selected products and clinical programs.
Denosumab: The Company discussed that the U.S. Food and Drug Administration (FDA) granted priority review designation to denosumab for the treatment of bone metastases to reduce skeletal related events in patients with cancer. Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will target an Agency action within six months of the application submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of Thursday, November 18.
Vectibix: The Company announced that it now expects data from its Phase 3 study of Vectibix for the treatment of metastatic squamous cell carcinoma of the head and neck in the third 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 six months ended June 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 June 30, 2010. The Company believes that the presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 6
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.
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
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 7
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.
| CONTACT: | Amgen, Thousand Oaks David Polk, 805-447-4613 (media) Arvind Sood, 805-447-1060 (investors) |
###
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
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 June 30, 2010 |
Three Months Ended June 30, 2009 |
|||||||||||||||||||||
| GAAP | Adjustments | “Adjusted” | GAAP | Adjustments | “Adjusted” | |||||||||||||||||
| Revenues: |
||||||||||||||||||||||
| Product sales |
$ | 3,613 | $ | — | $ | 3,613 | $ | 3,634 | $ | — | $ | 3,634 | ||||||||||
| Other revenues |
191 | — | 191 | 79 | — | 79 | ||||||||||||||||
| Total revenues |
3,804 | — | 3,804 | 3,713 | — | 3,713 | ||||||||||||||||
| Operating expenses: |
||||||||||||||||||||||
| Cost of sales (excludes amortization of certain acquired intangible assets presented below) |
553 | (4 | )(a) | 549 | 531 | (3 | )(a) | 527 | ||||||||||||||
| (1 | )(f) | |||||||||||||||||||||
| Research and development |
675 | (16 | )(a) | 642 | 693 | (16 | )(a) | 657 | ||||||||||||||
| (17 | )(b) | (17 | )(b) | |||||||||||||||||||
| (3 | )(f) | |||||||||||||||||||||
| Selling, general and administrative |
986 | (18 | )(a) | 968 | 910 | (16 | )(a) | 891 | ||||||||||||||
| (3 | )(f) | |||||||||||||||||||||
| Amortization of certain acquired intangible assets |
73 | (73 | )(c) | — | 73 | (73 | )(c) | — | ||||||||||||||
| Other |
— | — | — | 49 | (20 | )(d) | — | |||||||||||||||
| (29 | )(f) | |||||||||||||||||||||
| Total operating expenses |
2,287 | (128 | ) | 2,159 | 2,256 | (181 | ) | 2,075 | ||||||||||||||
| Operating income |
1,517 | 128 | 1,645 | 1,457 | 181 | 1,638 | ||||||||||||||||
| Interest expense, net |
147 | (66 | )(e) | 81 | 150 | (62 | )(e) | 88 | ||||||||||||||
| Interest and other income, net |
94 | — | 94 | 50 | — | 50 | ||||||||||||||||
| Income before income taxes |
1,464 | 194 | 1,658 | 1,357 | 243 | 1,600 | ||||||||||||||||
| Provision for income taxes |
262 | 70 | (g) | 332 | 88 | 86 | (h) | 289 | ||||||||||||||
| 115 | (i) | |||||||||||||||||||||
| Net income |
$ | 1,202 | $ | 124 | $ | 1,326 | $ | 1,269 | $ | 42 | $ | 1,311 | ||||||||||
| Earnings per share: |
||||||||||||||||||||||
| Basic |
$ | 1.25 | $ | 1.38 | $ | 1.25 | $ | 1.29 | ||||||||||||||
| Diluted (k) |
$ | 1.25 | $ | 1.38 | (a) | $ | 1.25 | $ | 1.29 | (a) | ||||||||||||
| Average shares used in calculation of earnings per share: |
||||||||||||||||||||||
| Basic |
959 | 959 | 1,013 | 1,013 | ||||||||||||||||||
| Diluted (k) |
964 | 964 | (a) | 1,017 | 1,016 | (a) | ||||||||||||||||
(a) - (k) See explanatory notes on the following pages.
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 9
Amgen Inc.
Condensed Consolidated Statements of Income and
Reconciliation of GAAP Earnings to “Adjusted” Earnings
(In millions, except per share data)
(Unaudited)
| Six months ended June 30, 2010 |
Six months ended June 30, 2009 |
||||||||||||||||||||||
| GAAP | Adjustments | “Adjusted” | GAAP | Adjustments | “Adjusted” | ||||||||||||||||||
| Revenues: |
|||||||||||||||||||||||
| Product sales |
$ | 7,141 | $ | — | $ | 7,141 | $ | 6,872 | $ | — | $ | 6,872 | |||||||||||
| Other revenues |
255 | — | 255 | 149 | — | 149 | |||||||||||||||||
| Total revenues |
7,396 | — | 7,396 | 7,021 | — | 7,021 | |||||||||||||||||
| Cost of sales (excludes amortization of certain acquired intangible assets presented below) |
1,061 | (8 | )(a) | 1,053 | 1,008 | (6 | )(a) | 1,001 | |||||||||||||||
| (1 | )(f) | ||||||||||||||||||||||
| Research and development |
1,321 | (28 | )(a) | 1,259 | 1,326 | (27 | )(a) | 1,262 | |||||||||||||||
| (34 | )(b) | (34 | )(b) | ||||||||||||||||||||
| (3 | )(f) | ||||||||||||||||||||||
| Selling, general and administrative |
1,870 | (29 | )(a) | 1,841 | 1,708 | (26 | )(a) | 1,665 | |||||||||||||||
| (17 | )(f) | ||||||||||||||||||||||
| Amortization of certain acquired intangible assets |
147 | (147 | )(c) | — | 147 | (147 | )(c) | — | |||||||||||||||
| Other |
(1 | ) | 1 | (d) | — | 54 | (20 | )(d) | — | ||||||||||||||
| (34 | )(f) | ||||||||||||||||||||||
| Total operating expenses |
4,398 | (245 | ) | 4,153 | 4,243 | (315 | ) | 3,928 | |||||||||||||||
| Operating income |
2,998 | 245 | 3,243 | 2,778 | 315 | 3,093 | |||||||||||||||||
| Interest expense, net |
292 | (131 | )(e) | 161 | 297 | (123 | )(e) | 174 | |||||||||||||||
| Interest and other income, net |
178 | — | 178 | 108 | — | 108 | |||||||||||||||||
| Income before income taxes |
2,884 | 376 | 3,260 | 2,589 | 438 | 3,027 | |||||||||||||||||
| Provision for income taxes |
515 | 137 | (g) | 652 | 301 | 155 | (h) | 596 | |||||||||||||||
| 115 | (i) | ||||||||||||||||||||||
| 25 | (j) | ||||||||||||||||||||||
| Net income |
$ | 2,369 | $ | 239 | $ | 2,608 | $ | 2,288 | $ | 143 | $ | 2,431 | |||||||||||
| Earnings per share: |
|||||||||||||||||||||||
| Basic |
$ | 2.44 | $ | 2.69 | $ | 2.24 | $ | 2.38 | |||||||||||||||
| Diluted (k) |
$ | 2.43 | $ | 2.67 | (a) | $ | 2.23 | $ | 2.37 | (a) | |||||||||||||
| Average shares used in calculation of earnings per share: |
|||||||||||||||||||||||
| Basic |
970 | 970 | 1,023 | 1,023 | |||||||||||||||||||
| Diluted (k) |
976 | 976 | (a) | 1,027 | 1,026 | (a) | |||||||||||||||||
(a) - (k) See explanatory notes on the following pages.
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
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 six months ended June 30, 2010 and 2009, the total pre-tax expense for employee stock options was $38 million and $65 million, respectively, and $35 million and $59 million, respectively. |
“Adjusted” diluted EPS including the impact of stock option expense for the three and six months ended June 30, 2010 and 2009 was as follows:
| Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| “Adjusted” diluted EPS, excluding stock option expense |
$ | 1.38 | $ | 1.29 | $ | 2.67 | $ | 2.37 | ||||||||
| Impact of stock option expense (net of tax) |
(0.04 | ) | (0.02 | ) | (0.05 | ) | (0.04 | ) | ||||||||
| “Adjusted” diluted EPS, including stock option expense |
$ | 1.34 | $ | 1.27 | $ | 2.62 | $ | 2.33 | ||||||||
| (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 loss accruals or awards for legal settlements. |
| (e) | To exclude the incremental non-cash interest expense resulting from a change in the accounting for our convertible notes effective January 1, 2009. |
| (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 recognized as a result of resolving certain non-routine transfer pricing issues with the Internal Revenue Service (“IRS”) 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) | 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 June 30, 2010 |
Three months ended June 30, 2009 |
|||||||||||||
| GAAP | “Adjusted” | GAAP | “Adjusted” | |||||||||||
| Income (Numerator): |
||||||||||||||
| Net income for basic and diluted EPS |
$ | 1,202 | $ | 1,326 | $ | 1,269 | $ | 1,311 | ||||||
| Shares (Denominator): |
||||||||||||||
| Weighted-average shares for basic EPS |
959 | 959 | 1,013 | 1,013 | ||||||||||
| Effect of dilutive securities |
5 | 5 | (*) | 4 | 3 | (*) | ||||||||
| Weighted-average shares for diluted EPS |
964 | 964 | 1,017 | 1,016 | ||||||||||
| Diluted earnings per share |
$ | 1.25 | $ | 1.38 | $ | 1.25 | $ | 1.29 | ||||||
| Six months ended June 30, 2010 |
Six months ended June 30, 2009 |
|||||||||||||
| GAAP | “Adjusted” | GAAP | “Adjusted” | |||||||||||
| Income (Numerator): |
||||||||||||||
| Net income for basic and diluted EPS |
$ | 2,369 | $ | 2,608 | $ | 2,288 | $ | 2,431 | ||||||
| Shares (Denominator): |
||||||||||||||
| Weighted-average shares for basic EPS |
970 | 970 | 1,023 | 1,023 | ||||||||||
| Effect of dilutive securities |
6 | 6 | (*) | 4 | 3 | (*) | ||||||||
| Weighted-average shares for diluted EPS |
976 | 976 | 1,027 | 1,026 | ||||||||||
| Diluted earnings per share |
$ | 2.43 | $ | 2.67 | $ | 2.23 | $ | 2.37 | ||||||
| (*) | Dilutive securities used to compute “Adjusted” diluted earnings per share for the three and six months ended June 30, 2010 and 2009 were computed under the treasury stock method assuming that we do not expense stock options. |
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 11
Amgen Inc.
Product Sales Detail by Product and Geographic Region
(In millions)
(Unaudited)
| Three months ended June 30, |
Six months ended June 30, | |||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||
|
Aranesp® - U.S. |
$ | 267 | $ | 338 | $ | 535 | $ | 630 | ||||
|
Aranesp® - International |
336 | 355 | 695 | 689 | ||||||||
|
EPOGEN® - U.S |
657 | 638 | 1,280 | 1,203 | ||||||||
|
Neulasta® - - U.S. |
643 | 625 | 1,280 | 1,219 | ||||||||
|
NEUPOGEN® - - U.S. |
225 | 230 | 450 | 432 | ||||||||
|
Neulasta® - - International |
218 | 206 | 444 | 389 | ||||||||
|
NEUPOGEN® - - International |
88 | 97 | 179 | 191 | ||||||||
|
Enbrel® - U.S. |
819 | 846 | 1,573 | 1,558 | ||||||||
|
Enbrel® - Canada |
58 | 53 | 108 | 99 | ||||||||
|
Sensipar® - - U.S. |
112 | 113 | 229 | 212 | ||||||||
|
Sensipar® - - International |
60 | 54 | 122 | 103 | ||||||||
|
Vectibix® - - U.S. |
29 | 24 | 54 | 49 | ||||||||
|
Vectibix® - - International |
43 | 32 | 85 | 60 | ||||||||
|
Nplate® - U.S. |
32 | 19 | 60 | 32 | ||||||||
|
Nplate® - International |
23 | 4 | 44 | 6 | ||||||||
|
Prolia® - U.S. |
3 | — | 3 | — | ||||||||
| Total product sales |
$ | 3,613 | $ | 3,634 | $ | 7,141 | $ | 6,872 | ||||
| U.S. |
$ | 2,787 | $ | 2,833 | $ | 5,464 | $ | 5,335 | ||||
| International |
826 | 801 | 1,677 | 1,537 | ||||||||
| Total product sales |
$ | 3,613 | $ | 3,634 | $ | 7,141 | $ | 6,872 | ||||
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 12
Amgen Inc.
Condensed Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
| June 30, 2010 |
December 31, 2009 | |||||
| Assets |
||||||
| Current assets: |
||||||
| Cash, cash equivalents and marketable securities |
$ | 14,523 | $ | 13,442 | ||
| Trade receivables, net |
2,208 | 2,109 | ||||
| Inventories |
2,112 | 2,220 | ||||
| Other current assets |
1,321 | 1,161 | ||||
| Total current assets |
20,164 | 18,932 | ||||
| Property, plant and equipment, net |
5,630 | 5,738 | ||||
| Intangible assets, net |
2,421 | 2,567 | ||||
| Goodwill |
11,334 | 11,335 | ||||
| Other assets |
1,251 | 1,057 | ||||
| Total assets |
$ | 40,800 | $ | 39,629 | ||
| Liabilities and Stockholders’ Equity |
||||||
| Current liabilities: |
||||||
| Accounts payable and accrued liabilities |
$ | 3,578 | $ | 3,873 | ||
| Current portion of convertible notes |
2,414 | — | ||||
| Total current liabilities |
5,992 | 3,873 | ||||
| Convertible notes |
2,232 | 4,512 | ||||
| Other long-term debt |
7,086 | 6,089 | ||||
| Other non-current liabilities |
2,320 | 2,488 | ||||
| Stockholders’ equity |
23,170 | 22,667 | ||||
| Total liabilities and stockholders’ equity |
$ | 40,800 | $ | 39,629 | ||
| Shares outstanding |
958 | 995 | ||||
- MORE -
Amgen’s Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 13
Amgen Inc.
Reconciliation of GAAP Debt Outstanding to “Adjusted” Debt Outstanding
(In millions)
(Unaudited)
| June 30, 2010 | ||||||||||
| GAAP | Adjustments for accounting standard |
“Adjusted” | ||||||||
| Total debt outstanding |
$ | 11,732 | $ | 437 | (a) | $ | 12,169 | |||
| (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 Second Quarter Adjusted EPS Increased 7 Percent to $1.38;
Second Quarter Revenue Increased 2 Percent to $3.8 Billion
Page 14
Amgen Inc.
Reconciliation of GAAP Earnings Per Share Guidance to “Adjusted”
Earnings Per Share Guidance for the Year Ending December 31, 2010
(Unaudited)
On July 29, 2010, the Company reaffirmed its “Adjusted” earnings per share guidance towards the lower end of the range of $5.05 - $5.25, including an anticipated impact of $200 million to $250 million due to U.S. Health Care Reform. 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 |
$4.55 - $4.77 | ||
| 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) |
0.07 - 0.09 | ||
| Amortization of acquired intangible assets, R&D technology rights (d) |
0.05 | ||
| “Adjusted” earnings per share (diluted) guidance |
$5.05 - $5.25 | ||
| * | The known adjustments are presented net of their related aggregate tax impact of approximately $0.27 to $0.28 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. |
Amgen Inc.
Reconciliation of GAAP Tax Rate Guidance to “Adjusted”
Tax Rate Guidance for the Year Ending December 31, 2010
(Unaudited)
On July 29, 2010, the Company reaffirmed its “Adjusted” tax rate guidance range of 20.0% - 21.0%. The following table shows a reconciliation of GAAP tax rate guidance to “Adjusted” tax rate guidance.
| 2010 | |||
| GAAP tax rate guidance |
17.8% - 19.0 | % | |
| Tax rate effect of known adjustments discussed above |
2.0% - 2.2 | % | |
| “Adjusted” tax rate guidance |
20.0% - 21.0 | % | |