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VERTEX REPORTS 2007 3RD QTR NET LOSS OF $107 MILLION.

Biotech Financial Reports • Dec 1, 2007 •
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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), Cambridge, Mass., has reported consolidated financial results for the quarter ended September 30, 2007, and the company provided a pipeline update.

"In 2007, we have made great progress in all aspects of our business, and in particular with our investigational hepatitis C protease inhibitor, telaprevir," commented Joshua Boger, Ph.D., president and CEO of Vertex Pharmaceuticals. "The upcoming presentations at AASLD from PROVE 1 and PROVE 2, two of our major Phase 2b trials of telaprevir, represent an important event in the HCV field. It was more than 12 years ago that we and others began pursuing new mechanisms to directly inhibit the HCV virus. This will be the first presentation of sustained viral response data for a STAT-C agent in combination with pegylated interferon and ribavirin compared to pegylated interferon and ribavirin alone. This is truly a meaningful period in the advancement of therapies for HCV."

Third Quarter Results

For the quarter ended September 30, 2007, the company's GAAP net loss was $107.0 million, or $0.82 per share. The GAAP net loss for the quarter ended September 30, 2006 was $51.8 million, or $0.46 per share. The increase in the company's 2007 GAAP loss was principally driven by an increase in development investment to support the progression of telaprevir.

The non-GAAP loss, before certain charges, which include stock-based compensation and restructuring charges, for the quarter ended September 30, 2007 was $93.2 million, or $0.72 per share, compared to the non-GAAP loss, before certain charges and gains, of $47.9 million, or $0.42 per share, for the quarter ended September 30, 2006.

Total revenues for the quarter ended September 30, 2007 were $41.0 million, compared to $53.3 million for the third quarter of 2006. The decrease is primarily due to a reduction in revenues recognized from research-based collaborations, as the company has moved away from reliance on collaborative funding of its research operations.

Research and development (R&D) expenses for the quarter ended September 30, 2007 were $128.9 million, including $14.5 million of commercial supply investment in telaprevir, compared to $96.1 million, including $10.5 million in commercial supply investment, in R&D expenses for the third quarter of 2006. The increase primarily relates to development investment to support the global Phase 2b clinical development program for telaprevir.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2007 were $21.4 million, compared to $14.8 million for the third quarter of 2006. This increase reflects building of infrastructure, including an increase in the number of employees and the initial commercial investments, to support advancement of the business. Other income, net, for the quarter ended September 30, 2007 was $6.8 million, compared to $3.6 million for the third quarter of 2006. This increase principally resulted from higher levels of invested funds and higher portfolio yields during the third quarter, and the company's reduction of outstanding debt in 2006 and in the first quarter of 2007. At September 30, 2007, Vertex had approximately $514.5 million in cash, cash equivalents and marketable securities.

Recent Achievements and 2007 Objectives

Telaprevir Development Program

--Telaprevir data to be presented at AASLD

-- Data from PROVE 1 and PROVE 2, two major Phase 2b trials of telaprevir, will be presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 2-6. These data will provide significant insight into rapid viral decline and rapid virologic response (RVR) rates as predictors of sustained viral responses (SVRs).

-- In addition, the PROVE 1 and PROVE 2 presentations will include safety analyses that will further characterize the safety profile of telaprevir in more than 500 patients. In clinical trials of telaprevir, the most common adverse events reported to date, regardless of treatment assignment, were fatigue, rash, headache and nausea. Gastrointestinal disorders, rash and anemia have been more common in the telaprevir dosing arms.

-- A total of six abstracts were accepted for presentation at AASLD, including presentations that contain off-study, follow-on data from a 14-day Phase 1b trial of telaprevir with pegylated interferon, and a 28-day Phase 1b trial of telaprevir with pegylated interferon and ribavirin.

--Update on global Phase 2b PROVE program

-- Vertex and Tibotec are currently in discussions with U.S. and European regulatory authorities to review clinical data and discuss how best to evaluate telaprevir in future trials. Vertex and Tibotec have provided additional data to these authorities, including the results to be disclosed at AASLD. Vertex expects to provide an update on its discussions with the U.S. Food and Drug Administration (FDA) as discussions are completed.

-- More than 1,000 patients are enrolled in the Phase 2b PROVE program. Data emerging from the PROVE 1 and PROVE 2 trials are being used to design the registration path for telaprevir. The PROVE 3 clinical trial in HCV patients who have not achieved an SVR with a previous interferon-based treatment was fully enrolled in the second quarter of 2007. Vertex expects to continue to provide updates on the program at appropriate future medical conferences.

--Next generation HCV protease inhibitor selected for development

-- Vertex has selected a second-generation HCV protease inhibitor for development and expects to initiate Phase 1 clinical testing in healthy volunteers by the end of 2007. Pipeline of Novel Drug Candidates

--Broad program targeting cystic fibrosis (CF) is advancing

-- Vertex is conducting a randomized, double-blind, placebo-controlled Phase 2a trial of VX-770, which will evaluate how VX-770 affects biomarkers of the cystic fibrosis transmembrane regulator (CFTR) protein in patients with CF. The trial is expected to be completed in 2008.

-- Earlier this month, Vertex selected for development the corrector compound, VX-809, from the company's research efforts in collaboration with Cystic Fibrosis Foundation Therapeutics (CFFT). Vertex expects to begin Phase 1 development of VX-809 by the end of 2007.

--Merck conducting Aurora kinase inhibitor clinical development program

-- Vertex's collaborator Merck is seeking to develop multiple Aurora kinase inhibitors targeting a range of cancers. The lead compound MK-0457 (VX-680) is in a Phase 2 trial in patients with treatment-resistant chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemias (PH+ALL) containing the T315I BCR-ABL mutation as well as in Phase 1 combination with drugs used to treat these patients after failure of initial therapy.

--VX-702 completes two studies

-- In the third quarter, Vertex completed two clinical trials of VX-702: a 120-patient trial in rheumatoid arthritis in combination with methotrexate and a Thorough QTc study. Vertex believes that results from both studies support continued development of VX-702. Vertex plans to seek a collaborator to further develop this compound.

-- In the third quarter, Vertex and Kissei Pharmaceuticals concluded their agreement for the development and commercialization of VX-702 in the Far East. Vertex retains worldwide rights to VX-702. Financial Activities

-- In September, the company repaid the remaining $42.1 million outstanding principal balance of its 5% Convertible Subordinated Notes due September 19, 2007. Following this payment, Vertex does not have any outstanding convertible debt on its balance sheet. Full Year 2007 Financial Guidance This section contains forward-looking guidance about the financial outlook for Vertex Pharmaceuticals. Vertex is reiterating its guidance for 2007 GAAP and non-GAAP loss, which originally was provided on February 1, 2007. The company is revising its guidance for revenue and expense.

Loss:

-- Vertex reiterates that the FY 2007 GAAP net loss will be in the range of $360 to $390 million. This includes stock-based compensation expense and restructuring expense of approximately $60 million in total.

-- Vertex reiterates that its non-GAAP loss for 2007, excluding restructuring charges and stock-based compensation expense, will be in the range of $300 to $330 million.

--Fourth Quarter Revenue and Expense: Vertex expects fourth quarter 2007 revenue to increase over the third quarter of 2007, and expense to be consistent with the third quarter of 2007. --Cash, Cash Equivalents, and Marketable Securities: Vertex reiterates that it expects its cash, cash equivalents and marketable securities to be in excess of $450 million at the end of 2007.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

For more information, call 617/444-6108.


COPYRIGHT 2007 Worldwide Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.


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