HOUSTON, April 28, 2005 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced financial results for the first quarter ending March 31, 2005.
"In the first quarter, we saw the successful culmination of the corporate strategy put in place three years ago," commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "Our lead product, Thelin, achieved its clinical endpoint in STRIDE-2, with solid safety and efficacy data; we were able to better capitalize the Company through the issuance of $130 million of convertible notes; and we continued to attract the high quality talent necessary for bringing a new pharmaceutical product to the market. Moving forward, we expect to achieve a major company milestone this May with the submission of a New Drug Application for Thelin with the U.S. Food and Drug Administration, followed by a European submission later this year."
First Quarter 2005 Financial Overview
-- For the first quarter of 2005, the Company reported a net loss
of approximately $17.4 million, or $0.30 per basic and diluted
share, compared to a net loss of approximately $11.1 million, or
$0.21 per basic and diluted share for the same period last year.
The increased loss in the current quarter is primarily the result
of increased research and development costs associated with
late-stage trials with Thelin(TM) and work associated with the
upcoming regulatory submission.
-- Revenue in the first quarter of 2005 was approximately $2.5
million compared to $2.8 million for the same period in 2004. In
the first quarter, the Company's royalties on net sales of
Argatroban by GlaxoSmithKline increased to $2.3 million from $1.8
million earned in the same period in 2004, an increase of 31%.
-- Cash, cash equivalents and investments at March 31, 2005 were
$182.1 million compared to $69.1 million on December 31, 2004.
First Quarter Highlights
-- Encysive Pharmaceuticals announced topline data from STRIDE-2
pivotal trial in PAH. The Phase III trial met the primary endpoint
of improved six-minute walk in patients receiving 100 mg of
Thelin. The 100 mg group saw a statistically significant increase
of 31.4 meters over placebo (p=0.03). Bosentan (Tracleer(R)), the
only approved oral product for pulmonary arterial hypertension,
increased the six-minute walk by 29.5 meters. Importantly, Thelin
demonstrated a favorable safety profile. The 100 mg dose of Thelin
was associated with a 3% rate of liver function abnormality in the
18-week study, compared to 11% for bosentan and 6% for placebo.
Additional data will be presented at the annual meeting of the
American Thoracic Society on May 23, 2005 in San Diego.
-- Encysive completed a $130 million convertible senior note
offering which will support the clinical development and prelaunch
activities for Thelin, as well as the research and development of
the Company's product candidates.
-- Encysive announced two key management appointments -- Toby W.
Juvenal as Vice President of Sales and Morris E. Cheeks, M.D. as
Senior Director of Medical Affairs. The appointments strengthen
the Company's commercial operations as it prepares for the
possible launch of Thelin in 2006.
-- The Company continued to receive strong interest from the
investment community. Investor presentations were made during the
quarter at the JP Morgan, Brean Murray & Co., Smith Barney
Citigroup, S.G. Cowen and BIO (Biotechnology Industry
Organization) CEO investor conferences.
-- In April 2005, the Company announced the signing of licensing
and capital-restructuring agreements with Revotar
Biopharmaceuticals AG, the Company's majority-owned German
subsidiary. Under the terms, Revotar's other shareholders will
contribute additional capital to Revotar, thereby reducing
Encysive's ownership to approximately 14%. In addition, Encysive
and Revotar will enter into a new licensing agreement regarding
bimosiamose, where Encysive would receive royalties on future
revenues from commercialization or licensing.
2005 Financial Guidance
Encysive has outlined estimated financial guidance for the year 2005, including royalty income from sales of Argatroban. Expenses reflect increased marketing and sales planning activity for the anticipated launch of Thelin and work related to submissions seeking regulatory approval for product marketing. In addition, expenses reflect increased development work on the Company's product pipeline.
(Amounts in millions)
Royalties on Argatroban $10.6-11.4
Revenues $11.2-12.5
Operating Expenses $89.0-95.0
Net Loss $(75.0)-(84.0)
Cash and Investments
at Year End $110-115
Upcoming Presentations
- May 2 Deutsche Bank, Baltimore, MD(a)
- May 4 Rodman & Renshaw, Paris, France(a)
- May 6 Morgan Stanley, Miami, FL(a)
- May 11 Annual Shareholder Meeting, New York, NY
- May 20-25 American Thoracic Society International Conference,
San Diego, CA
-Oral and Poster presentations, PAH Scientific
Symposia and analyst update(a)
- May 24 UBS 2005 Global Pharmaceutical Conference,
New York, NY(a)
- May 26 Needham Biotechnology Conference, New York, NY(a)
- June 8-11 EULAR (The European League Against Rheumatism),
Vienna, Austria
- June 22 Analyst Day, New York, NY(a)
- June 29 Wachovia Securities Nantucket Equity Conference,
Nantucket, MA(a)
(a) Meetings will be webcast at www.encysive.com
Conference Call Information
You may access the call either through the call-in number below or through the audio webcast. The access number for the call is:
Number: (612) 332-0932
Passcode: Encysive Pharmaceuticals
This call is being webcast and can be accessed via Encysive's web site at www.encysive.com.
A replay of the webcast will be available on the Company's web site through May 31, 2005. Additionally, a replay of the call will be available until Tuesday, May 3, 2005 at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844
Access Code: 778922
About Thelin and PAH
Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.
Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart/lung or lung transplantation. PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide, many of whom are children and young women.
Side effects of Thelin seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because Thelin inhibits the metabolism of warfarin, a decreased dose of warfarin is needed when co-administered with Thelin.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. We have successfully developed one FDA-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia that is marketed by GlaxoSmithKline. Our lead drug candidate, Thelin(TM) (sitaxsentan), is an endothelin receptor antagonist that has completed final Phase III clinical trials for the treatment of pulmonary arterial hypertension. In addition, we have earlier stage clinical product candidates in development including TBC3711, a next generation endothelin receptor antagonist. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com.
The Encysive Pharmaceuticals Inc. company logo can be found at http://media.primezone.com/prs/single/?pkgid=843
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are our estimate of the sufficiency of our existing capital resources, our ability to raise additional capital to fund cash requirements for future operations, timelines for initiating new clinical trials, planned announcements of clinical data, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, potential drug candidates, their potential therapeutic effect, market acceptance or our ability to earn a profit from sales or licenses of any drug candidate, our ability to discover new drugs in the future, and our ability to establish future collaborative arrangements. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. Encysive undertakes no duty to update or revise these forward-looking statements.
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
UNAUDITED SELECTED FINANCIAL DATA
Amounts in thousands (except per share data)
Consolidated Summary of Operations
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Three Months Ended March 31,
2005 2004
Revenues $ 2,540 $ 2,835
Operating expenses:
Research and development 16,784 12,015
General and administrative 3,812 2,485
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Total expenses 20,596 14,500
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Operating loss (18,056) (11,665)
Investment income, net 519 390
Interest expense (171) (40)
Minority interest in Revotar 265 194
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Net loss $(17,443) $(11,121)
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Net loss per common share:
(basic and diluted) $ (0.30) $ (0.21)
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Weighted average common shares outstanding
(basic and diluted) 57,656 52,178
Condensed Consolidated Balance Sheets
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March 31, Dec. 31,
2005 2004
Assets
Cash, cash equivalents, investments
and accrued interest $182,131 $ 69,101
Other assets 15,387 11,671
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Total assets 197,518 80,772
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Liabilities and stockholders' equity
Current liabilities 18,317 15,758
Long-term debt 131,658 1,730
Deferred revenue 2,252 1,119
Minority interest in Revotar 363 628
Stockholders' equity 44,928 61,537
Liabilities and stockholders' equity $197,518 $ 80,772
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