Vertex Reports:
Vertex Pharmaceuticals Reports Fourth Quarter and Full Year 2000 Financial Results
CAMBRIDGE, Mass., Feb 22, 2001 /PRNewswire via COMTEX/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX chart, msgs) reported financial results today for the three and 12 months ended December 31, 2000. The following financial results exclude the impact of the Company's adoption of the U.S. Securities and Exchange Commission's Staff Accounting Bulletin ("SAB") No. 101. For a discussion of SAB 101's impact on the Company's financial results, see the section titled "SAB 101" below.
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For the year ending December 31, 2000, the Company's net operating loss before debt conversion expense was $16,377,000, or $0.30 per basic and diluted share, compared with a net operating loss of $40,966,000, or $0.80 per basic and diluted share, for the year ending December 31, 1999. Total revenues from collaborative agreements and royalty revenue from sales of Agenerase(R) were $83,872,000 for the year ending December 31, 2000, as compared to $50,560,000 for the year ending December 31, 1999. For the year ending December 31, 2000, Vertex's royalty and product sales revenue of $12,036,000 was primarily based on worldwide sales of Agenerase by GlaxoSmithKline of approximately $79.3 million. Vertex's total costs and expenses for the year ended December 31, 2000, not including the debt conversion expense, were $100,249,000, compared with $91,526,000 for the year ended December 31, 1999.
As of December 31, 2000, Vertex had approximately $707,424,000 in cash, cash equivalents and short-term investments.
For the quarter ending December 31, 2000, the Company's net operating loss was $2,348,000, or $0.04 per basic and diluted share. For the fourth quarter of 1999, the Company's net income was $1,715,000, or $0.03 per basic and diluted share. Vertex recorded a profit in the fourth quarter of 1999 primarily as a result of initial payments received under the Company's collaboration with Aventis S.A.
Total revenues for the fourth quarter of 2000 were $25,449,000, as compared to $26,856,000 for the fourth quarter of 1999. Fourth-quarter 2000 revenues primarily consisted of payments under collaborative agreements as well as royalty revenue from Agenerase. The payments under collaborative agreements included research and development support as well as: $4.0 million in up-front and research payments from Serono S.A. for the caspase collaboration formed in December 2000; $1.5 million from Taisho Pharmaceutical Co. as the second half of an up-front payment received for signing a Far East caspase collaboration with that company in the fourth quarter of 1999; a $3.0 million milestone payment from GlaxoSmithKline for the European approval of Agenerase; and a $1.0 million milestone payment from Kissei Pharmaceutical Co. for the advancement of VX-702 into preclinical studies.
Vertex's financial results fluctuate from quarter to quarter based on the timing of product revenues, partnership payments, and drug development expenses.
"In 2000, Vertex's drug discovery and development enterprise progressed to a new level of product creation capability and downstream revenue opportunity," stated Joshua Boger, Ph.D., Chairman and CEO of Vertex Pharmaceuticals. "We advanced our drug design platform by taking a lead in the new field of chemogenomics, which represents the intersection of medicinal chemistry with the human genome. We made progress across our product pipeline and strengthened our financial position by raising more than $500 million in cash. We signed collaborative agreements with potential payments of approximately $900 million -- including a landmark deal with Novartis on the kinase family -- illustrating the value that Vertex creates in drug discovery for the Company and its partners."
"In 2001, our strategy is to expand our leadership position in the biotechnology sector," continued Dr. Boger. "We plan to invest significantly in research and development and enter new corporate collaborations that will enable us to maximize the potential of each product in our broad product pipeline. In addition, we intend to pursue the acquisition of technologies and products that can accelerate our drug discovery and development processes, further enhancing our productivity."
SAB 101
Pursuant to the adoption of SAB 101, the Company recorded a cumulative effect of a change in accounting principle retroactive to January 1, 2000, related to contract revenues recognized in prior periods. As a result, Vertex recorded a one-time, non-cash charge of $3,161,000. After giving effect to the implementation of SAB 101, Vertex's full year 2000 revenue, as adjusted, was $78,127,000 and deferred revenue was $12.6 million at December 31, 2000. After implementing SAB 101, the Company had a net operating loss of $22,122,000, or $0.41 per share, for the year ended December 31, 2000, not including the debt conversion expense of $14.4 million recorded in the third quarter of 2000 or the cumulative effect of the change in accounting principle of $3.1 million.
Pipeline Update
Agenerase and VX-175 (GW-433908)
-- Vertex presented data about its HIV franchise at a medical
conference held earlier this month. For the first time, a study
investigating once-daily dosing of Agenerase in combination with
ritonavir was presented. The Company also reported results from the
Phase II study of VX-175 suggesting that VX-175 has potent antiviral
activity, good tolerability and a strong pharmacokinetic profile.
VX-175 entered into Phase III pivotal studies in the fourth quarter of
2000. Agenerase and VX-175 are HIV protease inhibitors discovered by
Vertex and licensed for development and commercialization to
GlaxoSmithKline.
VX-745
-- Vertex completed a pilot Phase II program for VX-745 during 2000 and,
in January 2001, began a dose-ranging multi-center, double-blinded,
placebo-controlled Phase II clinical trial with VX-745 in patients with
rheumatoid arthritis. Vertex is taking this compound forward through
clinical development with its Far East partner, Kissei. Vertex retains
U.S. and European commercial rights.
VX-497 (merimempodib)
-- Vertex has completed a preliminary analysis of a Phase II clinical
trial of VX-497 in combination with interferon alpha. VX-497 is an
IMPDH inhibitor in development by Vertex for the treatment of Hepatitis
C. Following completion of the core study, patients have been rolled
onto standard antiviral therapy consisting of ribavirin plus interferon
alpha (Rebetron(TM)). The preliminary results of the core study
indicate that further clinical development of VX-497 is warranted. The
Company is continuing its analysis of the data with the goal of
designing subsequent clinical trials in combination with the new long-
lasting pegylated interferon products. Vertex retains worldwide
commercial rights to VX-497.
Timcodar
-- Vertex is continuing clinical development of timcodar, the Company's
lead drug candidate in its neurophilin program. Working with world
leaders in the field of neurology, in January 2001, Vertex began a
clinical study with a novel trial design. This trial is designed to
assess the activity of timcodar in a novel clinical paradigm. The
Company expects to provide additional information on this clinical
program in the second half of 2001.
Year 2001 Financial Outlook
This section contains forward-looking guidance about Vertex's financial outlook in 2001. This guidance reflects the impact of SAB 101, as discussed above.
-- Collaborative and other research and development revenue: For 2001,
Vertex anticipates that collaborative revenue will be in the
range of $19-$21 million per quarter. Collaborative revenue will
continue to fluctuate based on levels of research and development
support as well as potential revenue from milestone payments and
potential revenue from possible new deals.
-- Royalties and product sales: Based on current sales trends, for the
full year of 2001, Vertex assumes that Agenerase royalties will be in
the range of $13.50-$14.25 million based on worldwide sales of $90-$95
million. Agenerase, an HIV protease inhibitor, is Vertex's first
marketed product.
-- Other income, net: The Company anticipates that other income, net,
will be approximately $5 million per quarter in 2001.
-- R&D costs and expenses: Vertex is assuming that R&D costs and expenses
for 2001 will be fairly steady throughout the year, in the high $30
million to low $40 million range per quarter. The Company's R&D
expenditures will be higher than historical levels as a result of the
Company's commitment to make significant investments in its research
organization and in its industry-leading product pipeline.
-- SG&A: The Company expects SG&A to be in the $6-$7 million range per
quarter in 2001.
-- Net operating loss: Vertex expects that net operating loss for the
full year of 2001, reflecting SAB 101, will be in the range of $75-$80
million. While the Company will be making significant investments in
R&D, it will continue to focus on managing its expenses prudently.
-- Shares outstanding: Vertex's assumptions for weighted average number
of shares outstanding are approximately 60 million for the first
quarter, building to approximately 61 million for year end 2001.
-- Cash, cash equivalents and marketable securities: Vertex expects to
have in the range of $595-$600 million in cash, cash equivalents and
marketable securities at the end of 2001.
Vertex Pharmaceuticals Incorporated discovers, develops and markets small molecule drugs that address major unmet medical needs. The Company has 12 drug candidates in development to treat viral diseases, inflammation, cancer, autoimmune diseases and neurological disorders. Vertex has created its pipeline using a proprietary information-based approach to drug design that integrates multiple technologies in biology, chemistry and biophysics aimed at increasing the speed and success rate of drug discovery. Vertex's first approved product is Agenerase(R) (amprenavir), an HIV protease inhibitor, which Vertex co-promotes with GlaxoSmithKline.
This press release contains forward-looking statements. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. These risks and uncertainties include, among other things, the levels and timing of payments under our collaborative agreements, uncertainties relating to Vertex's ability to successfully discover, develop, test, secure regulatory approval of and finance any of its current or future drug candidates, uncertainties about Vertex's ability to obtain new corporate collaborations on satisfactory terms, if at all, and the risk that Vertex or its partners will not be able to successfully commercialize the products developed from Vertex research.
Conference Call and Webcast
Vertex Pharmaceuticals will host a conference call on February 22, 2001 at 10:00 a.m. ET to review financial results and recent developments. This call will be broadcast via the Internet at www.vrtx.com in the investor center.
Agenerase is a registered trademark of the GlaxoSmithKline group of companies.<<
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The whole PR, with the tables, is here:
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Cheers, Tuck |
