10-QPeriod: Q2 FY2007

AMGEN INC Quarterly Report for Q2 Ended Jun 30, 2007

Filed August 9, 2007For Securities:AMGN

Summary

Amgen Inc. reported its second-quarter and first-half 2007 financial results, showcasing a significant increase in net income compared to the prior year, largely due to the absence of a substantial write-off of in-process research and development (IPR&D) that impacted the 2006 period. Total revenues grew modestly, driven by strong performance in key products like Enbrel and Neulasta, though Aranesp faced headwinds due to U.S. sales declines. The company also incurred significant asset impairment charges related to manufacturing facility rationalization. Financially, Amgen ended the period with a robust cash position, although total debt increased due to new debt issuances to fund substantial share repurchases. The company is navigating significant regulatory and reimbursement challenges, particularly concerning its erythropoiesis-stimulating agents (ESAs) like Aranesp and Epogen, which are facing increased scrutiny and potential label changes and coverage restrictions that could materially impact future sales. Despite these challenges, Amgen completed two strategic acquisitions in July 2007, expanding its pipeline in diabetes and renal disorders.

Key Highlights

  • 1Net income for the six months ended June 30, 2007, was $2.13 billion, a significant increase from $1.015 billion in the prior year, primarily due to the absence of a $1.1 billion IPR&D write-off in 2006.
  • 2Total revenues for the six months increased by 8% to $7.415 billion, driven by product sales growth of 8% to $7.169 billion, led by Enbrel (+12%) and Neulasta/Neupogen (+8%).
  • 3Aranesp sales experienced a 10% decline in the second quarter and a 6% decline year-to-date in the U.S., primarily attributed to decreased demand following label and reimbursement changes related to anemia of cancer.
  • 4Amgen recorded $289 million in asset impairment charges and related costs in the second quarter due to rationalization of its manufacturing facilities.
  • 5The company significantly increased its debt, issuing $4.0 billion in new notes in May 2007 and used $3.2 billion of these proceeds for share repurchases.
  • 6Amgen repurchased approximately $5 billion of its common stock during the first half of 2007.
  • 7The company faces significant regulatory and reimbursement challenges for its erythropoiesis-stimulating agents (ESAs), with new coverage restrictions from CMS expected to materially impact Aranesp sales.
  • 8Subsequent to the quarter, Amgen completed the acquisitions of Alantos Pharmaceutical Holding, Inc. and Ilypsa, Inc., for approximately $300 million and $420 million, respectively.

Frequently Asked Questions

The primary driver for the significant increase in net income for the first half of 2007 is the absence of a $1.1 billion write-off of acquired in-process research and development (IPR&D) related to the Abgenix acquisition that occurred in the second quarter of 2006. This non-recurring charge significantly impacted the prior year's net income.

Amgen's ESAs are facing significant regulatory and reimbursement challenges. These include updated safety information and boxed warnings on labels due to clinical trial results, discontinuation of Medicare reimbursement for certain cancer-related anemia uses (Anemia of Cancer), and new coverage restrictions from the Centers for Medicare & Medicaid Services (CMS) for Aranesp in oncology. These factors are negatively impacting demand and sales, particularly for Aranesp in the U.S., and are expected to continue to pose headwinds.

Amgen significantly increased its long-term debt by issuing $4.0 billion in new notes in May 2007 to fund substantial share repurchases ($3.2 billion used from the issuance proceeds). Despite this increase in debt, the company maintained a strong cash and cash equivalents balance of $1.727 billion and marketable securities of $3.579 billion as of June 30, 2007. However, total cash, cash equivalents, and marketable securities decreased from $6.277 billion at the end of 2006 to $5.306 billion.

Amgen completed the acquisitions of Alantos Pharmaceutical Holding, Inc. and Ilypsa, Inc. shortly after the end of the quarter (July 2007). Alantos focuses on diabetes and inflammatory diseases, while Ilypsa specializes in drugs for renal disorders. These acquisitions expand Amgen's pipeline in key therapeutic areas and are expected to contribute to future growth, although the fair value of their IPR&D will be written off in the third quarter of 2007.