10-KPeriod: FY2008

AMGEN INC Annual Report, Year Ended Dec 31, 2008

Filed February 27, 2009For Securities:AMGN

Summary

Amgen Inc. reported total revenues of $15.0 billion for the fiscal year ended December 31, 2008, representing a 3% increase over the prior year. Net income was $4.2 billion, or $3.90 per diluted share. The company faced significant headwinds, particularly from regulatory and reimbursement developments affecting its erythropoiesis-stimulating agent (ESA) products, including Aranesp® and EPOGEN®. These challenges led to a material adverse impact on Aranesp® sales, especially in the U.S. supportive cancer care setting, and also affected EPOGEN® sales due to revised reimbursement policies. Despite these challenges, Amgen demonstrated resilience with strong sales growth in ENBREL® and Neulasta®/NEUPOGEN®. The company also made progress in its late-stage product candidate pipeline, notably with denosumab, for which a biologics license application was submitted to the FDA in December 2008. Amgen continued to manage its cost structure through restructuring initiatives, incurring $887 million in charges through December 31, 2008, with remaining estimated costs to be incurred in 2009.

Financial Highlights

51 data points
Beta

Revenue

$15.00B

Net Income

$4.05B

27.0% Net Margin

EPS (Diluted)

$3.77

Total Assets

$36.43B

Cash & Equivalents

$1.77B

Free Cash Flow

$5.32B

Financial Statements
Beta
Revenue$15.00B
SG&A Expenses$3.79B
Operating Expenses$9.79B
Operating Income$5.21B
Interest Expense$551.00M
Net Income$4.05B
EPS (Basic)$3.79
EPS (Diluted)$3.77
Shares Outstanding (Basic)1.07B
Shares Outstanding (Diluted)1.07B

Key Highlights

  • 1Total revenues reached $15.0 billion, a 3% increase year-over-year, driven by strong performance in ENBREL® and Neulasta®/NEUPOGEN®.
  • 2Net income was $4.2 billion, or $3.90 per diluted share.
  • 3Aranesp® and EPOGEN® sales experienced a decline primarily due to significant regulatory and reimbursement changes impacting the ESA class.
  • 4The company incurred $887 million in restructuring charges through December 31, 2008, as part of a plan to improve its cost structure.
  • 5Denosumab, a key late-stage product candidate, advanced with an FDA submission for the treatment and prevention of postmenopausal osteoporosis and bone loss.
  • 6Amgen continued its robust share repurchase program, repurchasing $2.3 billion of common stock during 2008.
  • 7The company ended the year with strong liquidity, reporting $9.6 billion in cash, cash equivalents, and marketable securities.

Frequently Asked Questions

Amgen's financial performance in 2008 was influenced by both positive and negative factors. Key drivers of revenue growth included strong sales for ENBREL® and Neulasta®/NEUPOGEN®. However, the company faced significant challenges from regulatory and reimbursement changes impacting its erythropoiesis-stimulating agent (ESA) products, Aranesp® and EPOGEN®, which led to a decline in their sales. Additionally, Amgen incurred substantial restructuring charges and legal settlement expenses.

Regulatory and reimbursement developments, including safety-related labeling changes and restricted Medicare reimbursement for ESAs, materially and adversely impacted Aranesp® sales, particularly in the U.S. supportive cancer care setting. Similar pressures affected EPOGEN® sales due to revised reimbursement policies and physician behavior changes related to dosing and utilization.

Amgen made notable progress in its pipeline. Denosumab, a key late-stage product candidate, advanced with the submission of a biologics license application to the FDA in December 2008 for osteoporosis and bone loss indications. The company continued to invest significantly in research and development across various therapeutic areas.

Amgen maintained a strong financial position, ending 2008 with $9.6 billion in cash, cash equivalents, and marketable securities. The company reported total debt of $10.2 billion. Amgen indicated that its existing funds and cash generated from operations were sufficient to meet its working capital, capital expenditure, and debt service requirements for the foreseeable future.