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 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), Amgens 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.
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. | ||
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 Prolia(TM) (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 Companys 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 Companys adjusted outstanding debt excludes the impact of a change in accounting on the carrying values of its convertible notes.
The Companys outstanding debt presented in accordance with GAAP was $11.7 billion as of June 30, 2010.
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 Companys 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 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 sciences 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 peoples 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 Companys results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.
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 | |||||||||||||||
June 30, 2010 | 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 | ||||||||||||||||
