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.
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