|
Quotes & Info
|
| AMGN > SEC Filings for AMGN > Form 10-Q on 11-May-2009 | All Recent SEC Filings |
11-May-2009
Quarterly Report
Forward looking statements
This report and other documents we file with the Securities and Exchange Commission ("SEC") contain forward looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business or others on our behalf, our beliefs and our management's assumptions. In addition, we, or others on our behalf, may make forward looking statements in press releases or written statements, or in our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Words such as "expect," "anticipate," "outlook," "could," "target," "project," "intend," "plan," "believe," "seek," "estimate," "should," "may," "assume," "continue," variations of such words and similar expressions are intended to identify such forward looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in "Item 1A. Risk Factors." We have based our forward looking statements on our management's beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecast by our forward looking statements. Reference is made in particular to forward looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources and trends. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.
Overview
The following Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to assist the reader in understanding the business of Amgen. MD&A is provided as a supplement to, and should be read in conjunction with, our condensed consolidated financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and our consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2008.
We are a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology. Our mission is to serve patients. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat grievous illness. We operate in one business segment - human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
We primarily earn revenues and income and generate cash from sales of human therapeutic products in the areas of supportive cancer care, nephrology and inflammation. Our principal products include Aranesp®, EPOGEN®, Neulasta®, NEUPOGEN® and ENBREL, all of which are sold in the United States. ENBREL is marketed under a co-promotion agreement with Wyeth in the United States and Canada. Our international product sales consist principally of European sales of Aranesp®, Neulasta® and NEUPOGEN®. International product sales represented approximately 23% and 21% of total product sales for the three months ended March 31, 2009 and 2008, respectively.
Aranesp® and EPOGEN® stimulate the production of red blood cells to treat anemia and belong to a class of drugs referred to as ESAs. Aranesp® is used for the treatment of anemia both in supportive cancer care and in nephrology. EPOGEN® is used to treat anemia associated with chronic renal failure ("CRF"). Neulasta® and NEUPOGEN® selectively stimulate the production of neutrophils, one type of white blood cell that helps the body fight infections. ENBREL blocks the biologic activity of tumor necrosis factor ("TNF") by inhibiting its binding to TNF receptors, a substance induced in response to inflammatory and immunological responses, such as rheumatoid arthritis and psoriasis. For the three months ended March 31, 2009 and 2008, our principal products represented 93% and 95%, respectively, of worldwide product sales. For additional
information about our principal products, their approved indications and where they are marketed, see "Item 1. Business - Marketed Products and Selected Product Candidates" in Part I of our Annual Report on Form 10-K for the year ended December 31, 2008.
We operate in a highly regulated industry and various U.S. and foreign regulatory bodies have substantial authority over how we conduct our business in those countries. Government authorities in the United States and in other countries regulate the manufacturing and marketing of our products and our ongoing R&D activities. The regulatory environment is evolving and there is increased scrutiny on drug safety and increased authority being granted to regulatory bodies, in particular the U.S. Food and Drug Administration ("FDA"), to assist in ensuring the safety of therapeutic products, which may lead to fewer products being approved by the FDA or other regulatory bodies or additional safety-related requirements or restrictions on the use of our products.
Most patients receiving our principal products for approved indications are covered by either government or private payer healthcare programs, which are placing greater emphasis on cost containment, including requiring that the economic value of products be clearly demonstrated. Governments may regulate access to, prices or reimbursement levels of our products to control costs or to affect levels of use of our products and private insurers may be influenced by government reimbursement methodologies. Worldwide use of our products may be affected by these cost containment pressures and cost shifting from governments and private insurers to healthcare providers or patients in response to ongoing initiatives to reduce or reallocate healthcare expenditures. Additionally, ongoing healthcare reform efforts could result in long-term changes to coverage and reimbursement that may also have a significant impact on our business. For example, the 2008 U.S. general elections resulted in a renewed focus on healthcare issues, and key elected and appointed officials have proposed significant reform to the U.S. healthcare system that would impact reimbursement of our products. In addition, a number of states are considering legislative proposals that would significantly alter their healthcare systems. Therefore, sales of our principal products are and will continue to be affected by the availability and extent of reimbursement from third-party payers, including government and private insurance plans, and administration of those programs.
Further, safety signals, trends, adverse events or results from clinical trials, studies or meta-analyses (a meta-analysis is the review of studies using various statistical methods to combine results from previous separate, but related, studies) performed by us or by others (including our licensees or independent investigators) or from the marketed use of our products may expand safety labeling, restrict the use of our approved products or may result in additional regulatory requirements, such as requiring risk management activities, including a risk evaluation and mitigation strategy ("REMS"), and/or additional or more extensive clinical trials as part of postmarketing commitments ("PMCs") or a pharmacovigilance program, and may negatively impact worldwide sales or reimbursement of our products.
Worldwide product sales for the three months ended March 31, 2009 decreased 8% compared to the prior year comparative period. Product sales in the United States for the three months ended March 31, 2009 totaled $2.5 billion, representing a decrease of 10% compared to the prior year comparative period. This decrease reflects, in part, approximately $120 million of benefit to ENBREL sales in the three months ended March 31, 2008 related to the initial wholesaler inventory stocking resulting from a change in ENBREL's distribution model. During the three months ended March 31, 2008, ENBREL's distribution model was converted from being primarily drop shipped to pharmacies to a wholesaler distribution model similar to our other products. International product sales for the three months ended March 31, 2009 totaled $736 million, reflecting a decrease of 2% compared to the prior year comparative period. The decrease in international product sales for the three months ended March 31, 2009 reflects unfavorable foreign currency exchange rate changes of $69 million. Excluding the impact of foreign currency exchange rate changes, worldwide product sales decreased 7% and international product sales increased 7% for the three months ended March 31, 2009. Worldwide product sales for the three months ended March 31, 2009 also reflect the divestiture of certain of our less significant products in the latter part of 2008. Worldwide sales of these products were $18 million for the three months ended March 31, 2008. Excluding the impact of the change in the ENBREL distribution model, the change in foreign currency exchange rates and the divestiture of certain of our less significant products, worldwide product sales would have declined by approximately 3%.
For the three months ended March 31, 2009, net income was $1,019 million compared to $1,100 million for the three months ended March 31, 2008, representing a decrease of 7%. Diluted earnings per share were $0.98 per share and $1.01 per share for the three months ended March 31, 2009 and 2008, respectively, representing a decrease of 3%.
The following is a discussion of selected key factors that have impacted and may continue to impact our business in 2009.
Economic Environment
Sales of our products and our results of operations for the three months ended March 31, 2009 were adversely affected by the current unprecedented global economic conditions. The negative impact on our business has been particularly evident in the United States where this economic downturn and, in part, the associated increase in unemployment, has resulted in a significant increase in the number of individuals whose private insurance coverage has been reduced or eliminated and/or who have assumed a larger portion of healthcare costs previously covered by their employers and/or who have reduced their out-of-pocket medical expenditures for various reasons, including high co-pays or unmet insurance deductibles. While it is not possible to accurately estimate the impact or extent of these developments, we believe that the current economic conditions have led to changes in patient behavior and spending patterns that have negatively affected usage of certain of our products, particularly products with higher co-pays, such as ENBREL. Such changes in behavior may include delaying treatment, rationing prescription medications, leaving prescriptions unfilled, reducing the frequency of visits to healthcare facilities, utilizing alternative therapies and/or foregoing health insurance coverage.
In addition to its effects on patients, the economic downturn may have also increased cost sensitivities among medical providers in the United States, such as oncology clinics, particularly in circumstances where providers may experience challenges in the collection of patient co-pays or be forced to absorb treatment costs as a result of coverage decisions or reimbursement terms. Moreover, the current economic conditions appear to have caused our wholesale distributors to lower their levels of inventory on hand, which we believe they have done to reduce their carrying costs and improve their results of operations. These inventory reductions also contributed to lower sales of certain of our products for the three months ended March 31, 2009.
Generally, sales of our products in the United States for the three months ended March 31 have been slightly lower relative to the immediately preceding three month period, which we believe to be due, in part, to various factors relating to wholesaler and customer buying patterns; including holiday-driven wholesaler and customer stocking, contract-driven customer buying and patients purchasing products later in the year after satisfying their annual insurance deductibles. As a result, demand for our products and wholesale distributor inventory levels in the United States are typically negatively impacted in the three months ended March 31. These effects have generally not been significant when comparing product sales in the three months ended March 31 with product sales for the corresponding three month period of the prior year. However, due to the current unprecedented economic environment discussed above, we believe that the effect of the above-noted factors on demand and wholesaler inventories in the three months ended March 31, 2009 has been amplified such that they have also adversely impacted our product sales in the three months ended March 31, 2009 when compared to the three months ended March 31, 2008.
Depending on the severity and duration of these economic conditions and their resulting impact on our business or on third-party payers, including governments and private insurance plans, wholesale distributors, customers, service providers and suppliers, our future product sales and results of operations may continue to be negatively impacted.
ESA Developments
Our ESA products have had and will continue to face future challenges, in particular, Aranesp® in the U.S. supportive cancer care setting. For example, on August 6, 2008, we revised the ESA product labeling, as the FDA directed, based on a complete response letter, received on July 30, 2008, from the FDA to the revisions to the ESA labeling we proposed following the March 13, 2008 Oncologic Drugs Advisory Committee ("ODAC") meeting. The revised labeling included, among other things, (i) the addition to the boxed warning of a statement that ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome of such therapy is cure, (ii) the addition of a statement in the DOSAGE and ADMINISTRATION section of the label that ESA therapy should not be initiated at hemoglobin ("Hb") levels † 10 grams per deciliter ("g/dL") and that dose should be adjusted to maintain the lowest Hb level sufficient to avoid red blood cell transfusions and (iii) the removal of reference to the upper safety limit of 12 g/dL. Furthermore, we are moving forward with a new randomized, double-blind, placebo-controlled, Phase 3 non-inferiority study evaluating overall survival when comparing advanced non-small cell lung cancer ("NSCLC") patients on Aranesp® to patients receiving placebo ("Study 782") as part of our Aranesp® pharmacovigilance program. We are currently identifying clinical sites for Study 782 and plan to begin patient enrollment this year. Additionally, in response to the FDA's request under authority prescribed by the Food and Drug Administration Amendments Act of 2007 (the "FDAAA"), we have submitted a proposed REMS and continue to work closely with the FDA to develop a REMS program for the class of ESA products. The components of the REMS approved by the FDA could be different for the use of ESAs in the oncology and nephrology indications. We believe that a REMS program for our ESA products could have a material adverse impact on the future sales of Aranesp®, especially in the U.S. supportive cancer care setting. Additionally, future Aranesp® sales could also be materially adversely impacted by further changes in reimbursement, including as a result of future regulatory developments.
Competition
Certain of our marketed products are under increased competitive pressures, including from biosimilar and other products in Europe, which compete or are expected to compete with Aranesp®, Neulasta® and NEUPOGEN®, as well as our marketed products in the United States, including ENBREL. For example, we have experienced and expect to continue to experience increased competition throughout Europe, including from a number of biosimilar erythropoietin products, which compete with Aranesp®. In addition, a number of G-CSF biosimilar products have received or are expected to receive marketing authorization from the European Commission, and have been or are expected to be launched and compete with Neulasta® and NEUPOGEN®. Further, in the United States, ENBREL will continue to face increased competition primarily due to the expected launch of new products, including competition from J&J's Simponi TM (golimumab), which was approved by the FDA in April 2009.
Other
Over the past several years, we have taken various actions to improve our cost structure, including a restructuring of our worldwide operations which we announced in August 2007. Subsequently, we identified various other initiatives designed to further assist in improving our cost structure. As of March 31, 2009, we have completed all of the actions and incurred all related costs initially included in our 2007 restructuring plan and have approximately $45 million to $90 million of costs remaining to be incurred with respect to the subsequently identified initiatives. Further, as a result of the recent economic downturn, we have also taken certain other actions to increase cost efficiencies and to reduce discretionary expenditures in order to allow us to continue to invest in our pipeline of product candidates, including denosumab, provide support for key products and assure product quality. Depending on the severity and duration of the current economic downturn, we may be required to take further actions to improve our cost structure.
As of March 31, 2009, cash, cash equivalents and marketable securities were $10.4 billion, of which approximately $8.0 billion was generated from operations in foreign tax jurisdictions and is intended for use in our foreign operations. If these funds were repatriated for use in our U.S. operations, we would be required to pay additional U.S. federal and state income taxes at the applicable marginal tax rates (see "Item 1A. Risk Factors - Significant changes to U.S. federal, state and foreign tax laws and regulations that apply to our operations and
activities could have a material adverse effect on our financial results." in Part II herein). Our total debt outstanding was $11.4 billion as of March 31, 2009, of which $1.0 billion is due in November 2009, which we expect to repay without incurring additional indebtedness.
There are many factors that affect us and our industry in general, including, among others, those relating to increased complexity and cost of R&D due, in part, to greater scrutiny of clinical trials with respect to safety which may lead to fewer treatments being approved by the FDA or other regulatory bodies and/or safety-related label changes for approved products; increasing restrictions on the use of our products; increasingly intense competition for marketed products and product candidates; reimbursement changes; healthcare provider prescribing behavior, regulatory or private healthcare organization medical guidelines and reimbursement practices; complex and expanding regulatory requirements and intellectual property protection. See "Item 1. Business" in Part I of our Annual Report on Form 10-K for the year ended December 31, 2008 and "Item 1A. Risk Factors" in Part II herein for further information on these economic and industry-wide factors and their impact and potential impact on our business.
Results of Operations
Product sales
For the three months ended March 31, 2009 and 2008, worldwide product sales and total product sales by geographic region were as follows (dollar amounts in millions):
Three months ended
2009 2008 Change
Aranesp® $ 626 $ 761 (18)%
EPOGEN® 565 554 2%
Neulasta®/NEUPOGEN® 1,073 1,086 (1)%
ENBREL 758 951 (20)%
Sensipar® 148 133 11%
Other 68 52 31%
Total product sales $ 3,238 $ 3,537
(8)%
Total U.S. $ 2,502 $ 2,788 (10)%
Total International 736 749 (2)%
Total product sales $ 3,238 $ 3,537
(8)%
|
Product sales are influenced by a number of factors, some of which may impact sales of certain of our existing products more significantly than others, including: demand, third-party reimbursement availability and policies, government programs, regulatory developments or guidelines, clinical trial outcomes, clinical practice, contracting and pricing strategies, wholesaler and end-user inventory management practices, patient population growth, fluctuations in foreign currency exchange rates, new product launches and indications, competitive products, product supply and acquisitions. In addition, general economic conditions may effect, and/or in some cases amplify, certain of these factors with a corresponding impact on our product sales.
Worldwide product sales for the three months ended March 31, 2009 decreased 8% compared to the prior year comparative period. Product sales in the United States for the three months ended March 31, 2009 totaled $2.5 billion, representing a decrease of 10% compared to the prior year comparative period. This decrease reflects, in part, approximately $120 million of benefit to ENBREL sales in the three months ended March 31, 2008 related to the initial wholesaler inventory stocking resulting from a change in ENBREL's distribution model. During the three months ended March 31, 2008, ENBREL's distribution model was converted from being primarily drop shipped to pharmacies to a wholesaler distribution model
similar to our other products. International product sales for the three months ended March 31, 2009 totaled $736 million, reflecting a decrease of 2% compared to the prior year comparative period. The decrease in international product sales for the three months ended March 31, 2009 reflects unfavorable foreign currency exchange rate changes of $69 million. Excluding the impact of foreign currency exchange rate changes, worldwide product sales decreased 7% and international product sales increased 7% for the three months ended March 31, 2009. Worldwide product sales for the three months ended March 31, 2009 also reflect the divestiture of certain of our less significant products in the latter part of 2008. Worldwide sales of these products were $18 million for the three months ended March 31, 2008. Excluding the impact of the change in the ENBREL distribution model, the change in foreign currency exchange rates and the divestiture of certain of our less significant products, worldwide product sales would have declined by approximately 3%.
Aranesp®
For the three months ended March 31, 2009 and 2008, total Aranesp® sales by geographic region were as follows (dollar amounts in millions):
Three months ended
2009 2008 Change
Aranesp® - U.S. $ 292 $ 405 (28)%
Aranesp® - International 334 356 (6)%
Total Aranesp® $ 626 $ 761 (18)%
|
U.S. Aranesp® sales in the three months ended March 31, 2009 were negatively impacted by $12 million from changes in accounting estimates related to accruals for sales incentives related to prior period sales. In addition, U.S. Aranesp® sales during the three months ended March 31, 2008 were positively impacted by $22 million due to a change in the accounting estimate related to product sales return reserves. Excluding the impact of these changes in accounting estimates, U.S. sales of Aranesp® declined 21% in the three months ended March 31, 2009. The decrease in U.S. Aranesp® sales was principally driven by a decline in demand, reflecting the negative impact, primarily in the supportive cancer care setting, of additional safety-related product label changes which occurred in August 2008, and, to a lesser extent, loss of segment share. The decline in sales during the three months ended March 31, 2009 was slightly offset by favorable changes in wholesaler inventories.
International Aranesp® sales for the three months ended March 31, 2009 decreased 6% due to the negative impact of changes in foreign currency exchange rates, which aggregated approximately $29 million, partially offset by an increase in demand. Excluding the impact of foreign currency exchange rate changes, international Aranesp® sales increased 2% for the three months ended March 31, 2009. For the three months ended March 31, 2009, the ESA segment in Europe has declined primarily due to price erosion, partially offset by growth in patient population. Through March 31, 2009, biosimilars and other recently introduced marketed products in Europe have not had a significant impact on total international Aranesp® segment share.
In addition to other factors mentioned in the "Product sales" section above, future worldwide Aranesp® sales will be dependent, in part, on such factors as:
• regulatory developments, including those resulting from:
† the proposed REMS for the class of ESAs, which we are discussing with the FDA, or other risk management activities undertaken by us or required by the FDA or other regulatory authorities;
† future product label changes;
† government's and/or third-party payer's reaction to regulatory developments, including the proposed REMS, which we are discussing with the FDA, and recent or future product label changes;
† current or future cost containment pressures by third-party payers, including governments and private insurance plans;
• severity and duration of the current global economic downturn;
• adverse events or results from clinical trials or studies or meta-analyses performed by us, including our pharmacovigilance clinical trials, or by others (including our licensees or independent investigators), which have and could further impact product safety labeling, negatively impact healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization medical guidelines and reimbursement practices;
• governmental or private organization regulations or guidelines relating to the use of our product;
. . .
|
|