SAN FRANCISCO, Jan 10, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.
"2010 will be a defining year for Vertex as we seek to evolve into a fully-capable biopharmaceutical company," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. "With ongoing Phase 3 programs in hepatitis C virus infection and cystic fibrosis, a broad pipeline of other emerging product candidate opportunities and a strong capital structure, we believe Vertex today has a unique opportunity to build a successful company focused on bringing multiple important therapies to patients. In 2010, we look forward to a series of defining events from late-stage and proof-of-concept clinical trials that may support further growth in the years ahead."
Mr. Emmens will deliver a live webcast presentation from the J.P. Morgan Healthcare Conference on Tuesday, January 12 at 2:30 p.m. PT (5:30 p.m. ET) where he will discuss recent clinical progress and provide an overview of Vertex's 2010 priorities. The webcast will be available on Vertex's website, www.vrtx.com.
"Phase 3 data for telaprevir, our lead drug candidate for the treatment of hepatitis C virus infection, will begin to emerge in the spring of 2010 to support the planned submission of a New Drug Application in the second half of this year. Our more than decade-long commitment to improving patient care in HCV is unwavering, and the Phase 3 program for telaprevir will remain our primary focus over the coming year. Importantly, we also recognize the need for continued innovation in the treatment of this disease, and we are preparing to initiate the first clinical trial combining telaprevir with the investigational HCV polymerase inhibitor VX-222 this quarter," stated Mr. Emmens.
"Beyond HCV, Vertex is conducting mid-stage and late-stage development of two novel compounds aimed at addressing, for the first time, the underlying mechanism of the orphan disease of cystic fibrosis. The VX-770 Phase 3 registration program is advancing rapidly, and we expect to obtain Phase 3 data for VX-770 early in 2011. Additionally, we also expect to obtain clinical data from a Phase 2 trial of VX-809 in the coming weeks that could potentially support the evaluation of VX-770 and VX-809 as part of a combination regimen in patients with the most common mutation of this disease.
"Supporting our vision to become a fully-capable biopharmaceutical company, Vertex is also planning multiple proof-of-concept clinical trials in other diseases, such as rheumatoid arthritis and epilepsy, and remains committed to maintaining investment into research to enable future product opportunities," concluded Mr. Emmens.
Phase 3 Registration Program for Telaprevir Nears Completion
Sustained viral response (SVR) data expected from Phase 3 ADVANCE trial in second quarter 2010 and from Phase 3 ILLUMINATE & REALIZE trials in third quarter 2010
Twice-daily dosing of telaprevir
Vertex collaborator completes dosing of telaprevir in Phase 3 trials in Japan
New capabilities to support potential launch of telaprevir
Potential Future Combination Regimens for HCV with Telaprevir and the HCV Polymerase Inhibitor VX-222
Initiation of first clinical trial of telaprevir combined with VX-222 planned for first quarter 2010
Addressing the Underlying Defect of Cystic Fibrosis
VX-770 Phase 3 registration program progressing; STRIVE trial completes planned enrollment
Phase 2a trial of VX-809 complete; Data expected in first quarter 2010
Additional Proof-of-Concept Trials and Research Progress Support Future Growth
Janus kinase 3 (JAK3) inhibitor VX-509 to enter Phase 2 trial in rheumatoid arthritis
Caspase-1 inhibitor VX-765 to enter Phase 2 trial in epilepsy
Capital Structure Supports Investment into Key Business Priorities
"Vertex is committed to maintaining a strong balance sheet and capital structure that will support our mission to discover, develop and commercialize new medicines that provide high therapeutic benefit to patients with major diseases and deliver return to our shareholders," said Ian Smith, Executive Vice President and Chief Financial Officer of Vertex. "With a cash position of approximately $1.3 billion and approximately $32 million of 2013 convertible debt, Vertex enters 2010 in a strong financial position to support the advancement of our key development programs in HCV and CF and to generate important proof-of-concept clinical data in other significant diseases.
"As our late-stage compounds advance, the company's financial strategy will evolve toward ensuring that our potential marketed products provide financial support for continued investment in development programs and in product creation from research," continued Mr. Smith.
As of December 31, 2009, Vertex had approximately $1.3 billion in cash, cash equivalents and marketable securities, approximately $32 million of outstanding 2013 convertible notes and approximately 200 million shares outstanding.
Vertex anticipates a GAAP net loss for 2009 of less than $650 million. Vertex anticipates a 2009 non-GAAP loss of less than $515 million, excluding stock-based compensation and executive transition expenses, restructuring expense, acquisition-related expenses, loss on exchange of convertible subordinated notes, and interest expense related to the September 2009 financial transactions.
Vertex will report full-year 2009 financial results and financial guidance for 2010 on February 4, 2010.
Non-GAAP Financial Measures
In this press release, Vertex's financial results are provided both in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, Vertex provides guidance for its full-year 2009 loss, excluding stock-based compensation and executive transition expenses, restructuring expense, acquisition-related expenses, loss on exchange of convertible subordinated notes, and interest expense related to the September 2009 financial transactions, which results in a non-GAAP financial measure. These results are provided as a complement to results provided in accordance with GAAP because management believes these non-GAAP financial measures help indicate underlying trends in the Company's business and are important in comparing current results with prior period results. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, and to manage the Company's business and to evaluate its performance.
Vertex Pharmaceuticals will webcast its corporate presentation at the 28th Annual J.P. Morgan Healthcare Conference on January 12, 2010 at 2:30 p.m. PT (5:30 p.m. ET). A link to the live webcast will be available via Vertex's website, www.vrtx.com, in the Events & Presentations section. An archived webcast of the presentation will be available on Vertex's website through January 26, 2010.
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, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of companies.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) the potential to make NDA filings for telaprevir in the second half of 2010 and for VX-770 in the second half of 2011; (ii) the Company's expectations regarding the availability of clinical data from ADVANCE in the second quarter of 2010, from ILLUMINATE and REALIZE in the third quarter of 2010, from the VX-770 registration program early in 2011, and from the Phase 2 clinical trial of VX-809 in the first quarter of 2010; (iii) the initiation of planned proof-of-concept clinical trials with novel combination regimens for hepatitis C and cystic fibrosis and compounds for rheumatoid arthritis and epilepsy; (iv) Mr. Emmens' statements in the second and fourth through six paragraphs of this press release, including statements regarding planned or potential clinical trials, expected data from ongoing clinical trials, the company's priorities in 2010 and the company's opportunities for growth in 2010 and the years ahead; (v) the new activities Vertex is engaging in to support the potential launch of telaprevir; (vi) expectations regarding commencement of dosing and the number of patients in the STRIVE and DISCOVER clinical trials and the completion of enrollment for the ENVISION clinical trial; (vii) the timing of the initiation, the potential design and the date by which interim or final data would be obtained from the planned combination trial of telaprevir and VX-222, the potential combination trial of VX-770 and VX-809, the planned clinical trial of VX-509 and the planned clinical trial of VX-765; (viii) the potential of Vertex's drug candidates to treat the indications identified in the press release; (ix) the company's commitment to maintain a strong balance sheet, (x) the anticipation that the Company's projected GAAP and non-GAAP 2009 annual loss will be within the ranges set forth under the heading "Capital Structure Supports Investments Into Key Business Priorities" and that the Company's identified expenses for 2009 and capital structure, including its cash, cash equivalents and marketable securities balance, will be as set forth therein. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of its planned clinical trials and studies, and in particular its planned clinical trials of telaprevir, may not be favorable, that regulatory authorities may require supplemental clinical trials in order to support registration of telaprevir and/or VX-770, that planned or potential clinical trials may be delayed or may not be conducted, that the Company may not be able to successfully develop telaprevir, VX-770, VX-509, VX-765 or combination therapies involving telaprevir and VX-222 or VX-770 and VX-809, that the Company's expectations regarding its 2009 GAAP and non-GAAP net loss or financial position as of December 31, 2009 may be incorrect and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Vertex's press releases are available at www.vrtx.com.
(VRTX - GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Lora Pike, 617-444-6755
Zachry Barber, 617-444-6470 or 617-767-9533 (cell)
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