10-QPeriod: Q3 FY2008

AMGEN INC Quarterly Report for Q3 Ended Sep 30, 2008

Filed November 7, 2008For Securities:AMGN

Summary

Amgen Inc. reported strong financial results for the third quarter and the first nine months of 2008, showcasing robust revenue and net income growth compared to the prior year. Total revenues increased to $3.875 billion for the quarter and $11.252 billion for the nine months, driven by solid product sales, particularly in Neulasta/NEUPOGEN and ENBREL. The company also saw a significant improvement in operating income, jumping from $393 million in Q3 2007 to $1.483 billion in Q3 2008, largely due to the absence of significant restructuring and write-off charges from the prior year. Despite facing ongoing regulatory scrutiny and evolving reimbursement landscapes, especially for its erythropoiesis-stimulating agent (ESA) products, Amgen demonstrated resilience. The company maintained a healthy cash position, with cash and cash equivalents and marketable securities growing to $9.8 billion. Amgen also continued its commitment to returning capital to shareholders through stock repurchases, while managing its debt effectively. The company's proactive management of R&D spending and ongoing restructuring efforts appear to be contributing to a more efficient operational structure, positioning it for future growth.

Financial Statements
Beta
Revenue$3.88B
SG&A Expenses$900.00M
Operating Expenses$2.39B
Operating Income$1.48B
Interest Expense$133.00M
Net Income$1.12B
EPS (Basic)$1.06
EPS (Diluted)$1.05
Shares Outstanding (Basic)1.06B
Shares Outstanding (Diluted)1.06B

Key Highlights

  • 1Total revenues for Q3 2008 increased by 7% year-over-year to $3.875 billion, and by 3% for the first nine months to $11.252 billion.
  • 2Net income significantly improved, reaching $1.158 billion ($1.09/share diluted) for Q3 2008, a substantial increase from $201 million ($0.18/share diluted) in Q3 2007. For the nine months, net income was $3.235 billion ($3.00/share diluted), up from $2.331 billion ($2.06/share diluted) in the prior year.
  • 3Operating income saw a significant increase, reaching $1.483 billion in Q3 2008 compared to $393 million in Q3 2007, reflecting improved operational efficiency and the absence of major one-time charges from the prior year.
  • 4Cash, cash equivalents, and marketable securities increased to $9.8 billion as of September 30, 2008, up from $7.2 billion at the end of 2007, indicating strong liquidity.
  • 5Amgen repurchased $1.568 billion of its common stock in the first nine months of 2008, demonstrating a continued commitment to shareholder returns.
  • 6International product sales showed strong growth, up 20% for the quarter and 16% for the nine months, driven partly by favorable foreign currency exchange rates.
  • 7The company highlighted ongoing efforts to manage regulatory challenges, particularly with its ESA products, and continued investment in R&D and pipeline development, including positive results for denosumab in osteoporosis trials.

Frequently Asked Questions

Amgen's Q3 2008 financial performance was driven by solid growth in product sales, particularly from Neulasta/NEUPOGEN and ENBREL. The company also benefited from improved operating efficiencies and the absence of significant one-time charges that impacted the prior year's results. These factors combined to deliver a substantial increase in both revenue and net income.

Amgen is actively working with regulatory authorities like the FDA to update product labeling and implement risk management strategies for its ESA products. The company has finalized labeling changes as directed by the FDA and is submitting proposals for Risk Evaluation and Mitigation Strategies (REMS) for Aranesp® in oncology. Amgen is also conducting further clinical trials to determine the effects of ESAs on survival and tumor outcomes, as required by regulators.

Amgen maintains a strong financial position with $9.8 billion in cash, cash equivalents, and marketable securities as of September 30, 2008. Operating activities generated significant cash flow, and the company continues to have access to credit facilities. Amgen also demonstrated a commitment to shareholder returns through substantial stock repurchases.

Yes, Amgen is preparing to adopt new accounting standards. FSP APB 14-1, related to convertible debt, is expected to result in a material adverse impact on reported net income due to increased non-cash interest expense, although it will not affect cash flows. The company is also assessing the impact of EITF 07-5 on its financial statements.