10-KPeriod: FY2008

VERTEX PHARMACEUTICALS INC / MA Annual Report, Year Ended Dec 31, 2008

Filed February 17, 2009For Securities:VRTX

Summary

Vertex Pharmaceuticals Inc. is focused on the development and commercialization of small molecule drugs for serious diseases, with its lead candidate, telaprevir, a protease inhibitor for Hepatitis C (HCV) infection, being a significant area of investment. The company is progressing telaprevir through late-stage clinical trials for genotype 1 HCV and anticipates an NDA submission in the second half of 2010. Another key focus is VX-770, a drug candidate for cystic fibrosis (CF), for which a registration program is expected to begin in the first half of 2009. Vertex also has a diversified pipeline including other HCV drug candidates, a JAK3 inhibitor for immune-mediated inflammatory diseases, and oncology drug candidates through collaborations. Financially, Vertex reported a net loss for the year ended December 31, 2008, reflecting substantial ongoing investment in research and development. The company ended 2008 with a strong cash position and continues to explore financing options to support its extensive development activities.

Financial Statements
Beta
Revenue$175.50M
R&D Expenses$516.91M
SG&A Expenses$101.29M
Operating Expenses$638.21M
Operating Income-$462.71M
Interest Expense$13.47M
Net Income-$459.85M
EPS (Basic)$-3.27
EPS (Diluted)$-3.27
Shares Outstanding (Basic)140.56M
Shares Outstanding (Diluted)140.56M

Key Highlights

  • 1Vertex Pharmaceuticals is advancing telaprevir, its lead drug candidate for Hepatitis C, into late-stage Phase 3 clinical trials (ADVANCE, REALIZE) with an anticipated NDA submission in H2 2010.
  • 2The company is also developing VX-770 for cystic fibrosis, targeting patients with the G551D mutation, and plans to initiate a registration program in H1 2009.
  • 3Financial performance for the year ended December 31, 2008, showed a net loss of $459.9 million, with total revenues of $175.5 million, driven by significant investments in research and development.
  • 4Vertex ended 2008 with a robust cash position of $832.1 million, providing substantial runway for ongoing and future development programs.
  • 5The company's strategy includes completing telaprevir development, establishing leadership in HCV treatment, developing its CF drug candidates, and investing in research across multiple therapeutic areas.
  • 6Vertex relies on strategic collaborations, such as with Janssen for telaprevir in territories outside North America, to support its development and commercialization efforts.

Frequently Asked Questions

Vertex Pharmaceuticals' primary focus is the discovery, development, and commercialization of small molecule drugs for serious diseases. Its most advanced drug candidate is telaprevir, an oral protease inhibitor for Hepatitis C (HCV) infection, which is currently in late-stage Phase 3 clinical trials.

Vertex Pharmaceuticals anticipates filing a New Drug Application (NDA) for telaprevir with the U.S. Food and Drug Administration (FDA) in the second half of 2010, assuming successful completion of its ongoing registration program.

As of December 31, 2008, Vertex Pharmaceuticals had $832.1 million in cash, cash equivalents, and marketable securities. The company incurred a net loss of $459.9 million for the year ended December 31, 2008, reflecting substantial investments in research and development.

Vertex is also developing VX-770, a drug candidate for cystic fibrosis (CF) aimed at patients with the G551D mutation, with a registration program expected to commence in the first half of 2009. The pipeline also includes other HCV drug candidates (VX-813, VX-985), VX-809 for CF, and VX-509, a JAK3 inhibitor for immune-mediated inflammatory diseases.