Figuring the pipeline updates to be more important than financial statements, here is VTRX' Q3 PR, sans numbers:
>>CAMBRIDGE, Mass., Nov. 4 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) reported financial results today for the three months and nine months ended September 30, 2002.
For the three months ending September 30, 2002, the Company's net loss was $33.5 million, or $0.44 per share, compared to a loss of $13.5 million, or $0.18 per share, in the third quarter of 2001. (The loss for 2001 is reported before merger related costs and one-time gains and charges. The net loss for 2001, including merger related costs and one-time charges was $11.5 million, or $0.15 per share.) The increased net loss was mainly a result of the Company's continued investment to support clinical development of Vertex branded products, specifically those focused on inflammation and autoimmune disease areas, as well as reduced revenue from PanVera LLC, Vertex's discovery tools and services business.
Total revenues for the three months ending September 30, 2002 were $34.3 million, compared to $40.4 million for the third quarter of 2001. Revenues from pharmaceutical operations were $21.4 million, compared to $20.5 million for the same period last year. Revenues from PanVera LLC were $12.9 million, compared to $19.9 million for the same period last year. PanVera LLC revenues were affected by the redirection of technologies and resources from the former Aurora business to Vertex's pharmaceutical business, and the timing of completion of certain contractual obligations. The obligations have recently been satisfied, and PanVera will record the revenue related to the contract in the fourth quarter.
Cost of royalty, product and service revenues for the three months ending September 30, 2002 was $6.6 million, as compared to $11.4 million in the same period last year. This decrease reflects the continued focus of PanVera LLC on higher margin product and licensing revenues, as well as the reduced revenues from this business during the quarter.
Research and development expenses for the three months ending September 30, 2002 were $50.6 million, compared to $38.6 million for the third quarter of 2001. The increase in research and development expenses in the third quarter of 2002 reflects the Company's commitment to advancing Vertex branded products in development in Vertex's inflammation and autoimmune programs and pursuing its productive multi-target gene family drug discovery programs.
Sales, general and administrative expenses for the three months ending September 30, 2002 were $12.9 million, as compared to $10.7 million for the third quarter of 2001.
Other income, net, for the three months ending September 30, 2002 was $2.4 million, as compared to $6.9 million for the third quarter of 2001. This decrease primarily reflects a lower interest rate environment in 2002.
At September 30, 2002, Vertex had approximately $651 million in cash, cash equivalents and available for sale securities. This provides Vertex the financial strength and flexibility to support attainment of its long-term goals.
"In 2002, Vertex has continued to build upon our strengths in discovering and developing novel oral drugs for major diseases. In particular, Vertex has made significant and clear progress across our clinical pipeline. During the coming months, Vertex expects to accomplish all the major R&D goals that were established for 2002," stated Joshua Boger, Ph.D., Chairman and CEO.
"In addition, Vertex continues to make clear progress on the research front, and a number of promising preclinical drug candidates are emerging as the result of our gene family-based discovery efforts. We are continuing to seek to leverage our gene family discovery expertise in the protein kinase gene family and are broadening our efforts in a number of clinically and commercially important families, such as proteases and ion channels," Dr. Boger continued. "We are encouraged by our research productivity in 2002 and believe that our discovery efforts will make important contributions to our broad product pipeline in the years ahead. We continue to direct our financial strength and investments toward Vertex branded product opportunities and look forward to providing details on our portfolio of R&D programs at our upcoming Investor Day to be held on November 18."
Product Pipeline Update
Product Pipeline Update: Partner-Driven Programs
Vertex and GSK recently announced that the interim analysis of the third study (Study 30003) from the Phase III pivotal program of the HIV protease inhibitor (PI) GW433908 (also known as 908 or VX-175) indicates that the 908 study arms have met their study endpoints at 24 weeks. Vertex also announced that GSK has now conducted preliminary 48-week analyses of two other pivotal studies of 908, the NEAT (also known as 30001) and SOLO (also known as 30002) studies. These analyses indicate that the 908 arms in each of these studies have met their study endpoints at 48 weeks.
Vertex anticipates that GSK will submit new drug applications for market approval of 908 in the U.S. and European Union in December 2002. The submissions will include clinical data from the three pivotal trials that are being completed with 908. Subsequent to the December 2002 submission, GSK plans to submit additional information from ongoing studies in support of the proposed commercial tablet. Based on GSK's plans, we are conservatively estimating that 908 can be approved and launched in the third or fourth quarter of 2003.
Vertex anticipates that additional data from the 908 pivotal trial program will be presented at upcoming medical conferences in 2002 and 2003. Vertex today announced that 48-week data from the SOLO study has been accepted as a late-breaker presentation at the 6th International Conference for Drug Therapy for HIV Infection in Glasgow, Scotland, November 17-21.
In October, Vertex and Aventis presented for the first time at a medical conference detailed pralnacasan Phase IIa RA clinical results at the American College of Rheumatology (ACR) 66th Annual Scientific Meeting. The trial results demonstrate that treatment with pralnacasan was well tolerated and led to positive anti-inflammatory effects in patients with RA. Further efficacy studies in RA and osteoarthritis are being designed to evaluate this exciting drug candidate.
Product Pipeline Update: Vertex-Driven Programs
Vertex made important progress with two compounds in its IMPDH program in the third quarter. Inhibitors of IMPDH have the potential to treat a wide range of conditions, including diseases involving immune system regulation, cell proliferation, and viral infection.
Vertex expects to soon begin dosing patients in a Phase II study of VX- 148, a second-generation inhibitor of IMPDH. This randomized, double-blind, placebo-controlled study will evaluate two different doses of VX-148 in psoriasis patients who will be treated for 12-weeks. The primary goal of this study will be to evaluate the safety, tolerability and pharmacokinetics of VX- 148. Vertex expects to provide top-line results from this study in the second half of 2003.
Vertex announced today that it has begun its first Phase I study in healthy volunteers of VX-944, a second-generation inhibitor of IMPDH. The primary objective of the study will be to evaluate the safety, tolerability, and pharmacokinetics of VX-944 compared to placebo. Preclinical data detailing VX-944's potential as an anticancer agent will be presented at the American Society of Hematology (ASH) Conference in Philadelphia this December.
Vertex announced today that it will complete Phase I evaluations of its second-generation p38 MAP kinase inhibitor, VX-702, in early 2003. This clinical study is designed to evaluate the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. Data from this study will be used to guide the design of future clinical trials. Potential indications for VX-702 include acute and chronic inflammatory diseases including RA and Crohn's disease.
Updated Full Year 2002 Financial Guidance
This section contains forward-looking guidance about the financial outlook for the consolidated company, which includes Vertex Pharmaceuticals and PanVera LLC.
"Vertex's fundamental business measures continue to be strong," stated Ian Smith, Vertex's Chief Financial Officer. "Throughout 2002, we have continued to achieve our clinical and research milestones. We have actively managed the financial profile of the Company, and more specifically, our investment into R&D and SG&A infrastructure costs, to support our broad pipeline."
"In early 2002, Vertex established financial guidance for the year based on an evaluation of our core business objectives, our strategy for achieving those objectives and the Company's financial profile," stated Mr. Smith. "Due to a challenging market environment in 2002, certain corporate objectives, such as signing a gene family, research-oriented collaboration and achieving an expected return on our invested cash and equivalents has been challenging. We are therefore revising our financial guidance, with respect to the net loss and revenues for the full year of 2002, as well as our year-end cash and equivalents position. Vertex continues to operate from a position of financial strength. We believe that our corporate and financial strategies are aligned to enable us to achieve our goal of becoming a major drug company."
Net Loss: Vertex expects that the full year 2002 net loss will be in the range of $100 million to $110 million. (Previous guidance was $80 million to $90 million.)
Total Revenue: Vertex anticipates that it will continue to receive significant funding from its collaborative partner base as well as the discovery tools and services business.
Collaborative Revenue and Royalties: Vertex expects collaborative revenue and royalties to be in the range of $80 million to $90 million for 2002. (Previous guidance was $100 million to $110 million.)
Product Sales and Service Revenues: Vertex expects product sales and service revenues to be in the range of $72 million to $77 million for 2002. (Previous guidance was $80 million to $85 million.)
Cash, Cash Equivalents and Available for Sale Securities: Vertex expects cash, cash equivalents and available for sale securities to be in excess of $610 million at the end of 2002. (Previous guidance was in excess of $650 million.)
Financial guidance provided in February 2002 with respect to Research and Development Expenses and Selling, General and Administrative Expenses remains unchanged. Vertex continues to achieve its research and development goals and has the infrastructure to support the near-term requirements of the business.<<
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Cheers, Tuck |
