HOUSTON, Aug. 7, 2006 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced financial results for the second quarter ended June 30, 2006.
Second Quarter Financial Overview
-- Revenues in the second quarter of 2006 were $3.7 million, as
compared to $3.0 million for the second quarter of 2005. This
increase was due to higher royalties on sales of Argatroban by
GlaxoSmithKline. Royalty income increased 23% to $3.3 million, as
compared to $2.7 million earned in the same period last year.
-- For the second quarter of 2006, the Company reported a net loss of
$28.0 million, or $0.48 per basic and diluted share, compared to a
net loss of $19.2 million, or $0.33 per basic and diluted share,
for the second quarter of 2005. The increased loss in the current
quarter, as compared to the second quarter of 2005, was primarily
the result of the investment in the U.S. sales force and increased
commercialization-related expenses.
-- Cash, cash equivalents and accrued interest at June 30, 2006, were
$75.4 million, compared to $127.9 million at December 31, 2005, and
$100.5 million at March 31, 2006. Due to the delay in the approval
of THELIN(tm) (sitaxsentan sodium), the Company now anticipates the
need to raise additional cash and is exploring various financing
options.
Recent Company Events
-- On May 25, 2006, the Company submitted its complete response to the
U.S. Food and Drug Administration (FDA), to address the issues and
concerns detailed in the March 24, 2006, approvable letter for
THELIN. The FDA, in turn, designated the review as a Class 1
resubmission. A new Prescription Drug User Fee Act (PDUFA) target
action date of July 24, 2006, was established.
-- On July 24, 2006, Encysive received a second approvable letter from
the FDA for THELIN. One of the substantive items raised in the
March 24 approvable letter remains unresolved. The FDA
acknowledged that the unresolved item is a matter of judgment and
expressed a willingness to consider new arguments to address this
remaining item. The FDA again offered the alternative of
conducting additional clinical work. The Company has initiated
active discussions with the Agency, and is in the process of
setting up a face-to-face meeting with the goal of attempting to
resolve the remaining item.
-- On June 2, 2006, the Company announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Agency for
the Evaluation of Medicinal Products (EMEA) issued a positive
opinion recommending the approval of THELIN(tm) 100 mg tablets as
a once daily oral treatment for patients with pulmonary arterial
hypertension. The CHMP's positive opinion will be considered by
the European Commission, and a final decision regarding marketing
approval for THELIN is expected within approximately 90 days from
the opinion date. Under the EMEA's centralized licensing
procedure, if approved, Encysive would be granted marketing
authorization for THELIN in all 25 member states of the European
Union.
-- In preparation for the launch of THELIN in Europe, Encysive has
established a European commercial organization, headquartered in
London. Sales and marketing organizations are currently being
developed in the United Kingdom, Germany and France, with other
countries to follow.
-- The Company presented new THELIN data from the STRIDE-2X trial at
the European League Against Rheumatism (EULAR) Annual European
Congress of Rheumatology in June 2006.
Upcoming Presentations
-- Sept. 2-6 World Congress of Cardiology
Barcelona, Spain
-- Sept. 2-6 European Respiratory Society 16th Annual Congress
Munich, Germany
-- Sept. 11-14 ThinkEquity Partners 4th Annual Growth Conference
San Francisco(a)
-- Sept. 25-28 UBS Global Life Sciences Conference
New York City(a)
(a) Meeting will be webcast at www.encysive.com
Conference Call Information
Encysive Pharmaceuticals will host a conference call to discuss second quarter 2006 earnings today at 8:00 a.m. ET. You may access the call either through the call-in number below or through the audio webcast. Please dial in 15 minutes prior to the start time to allow for call processing. The access number for the call is:
Number: (612) 332-0226 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 September 7, 2006. Additionally, a replay of the call will be available from Monday, August 7, 2006, at 11:30 a.m. ET until Thursday, August 10, 2006, at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844 Access Code: 838078
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. 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
Three Months Ended Six Months Ended
June 30, June 30
--------------------- ---------------------
2006 2005 2006 2005
-------- -------- -------- --------
Revenues $ 3,662 $ 2,976 $ 7,223 $ 5,462
Operating expenses:
Research and
development 14,676 17,366 33,055 33,681
Sales and marketing 11,767 3,263 21,603 4,380
General and
administrative 5,364 3,605 11,106 6,199
-------- -------- -------- --------
Total expenses 31,807 24,234 65,764 44,260
-------- -------- -------- --------
Operating loss (28,145) (21,258) (58,541) (38,798)
Investment income 1,085 1,339 2,384 1,933
Interest expense (978) (976) (1,958) (1,147)
-------- -------- -------- --------
Loss from
continuing
operations (28,038) (20,895) (58,115) (38,012)
Income from
discontinued
operations -- 1,661 -- 1,335
-------- -------- -------- --------
Loss before
cumulative effect
of change in
accounting
principle $(28,038) $(19,234) $(58,115) $(36,677)
Cumulative effect of
change in accounting
principle -- -- 107 --
-------- -------- -------- --------
Net loss $(28,038) $(19,234) $(58,008) $(36,677)
Net loss per common
share
Basic and diluted $ (0.48) $ (0.33) $ (0.99) $ (0.63)
======== ======== ======== ========
Weighted average
common shares
Outstanding: basic
and diluted 58,465 57,895 58,368 57,776
======== ======== ======== ========
Condensed Consolidated Balance Sheets
-------------------------------------
June 30, December 31,
2006 2005
--------- ----------
Assets:
Cash, cash equivalents and
Accrued interest $ 75,417 $127,913
Other assets 17,727 18,789
-------- --------
Total assets 93,144 146,702
======== ========
Liabilities and stockholders' deficit
Current liabilities 26,664 26,151
Deferred revenue, long-term 642 1,286
Long-term debt 130,000 130,000
-------- --------
Total liabilities 157,306 157,437
Stockholders' deficit (64,162) (10,735)
-------- --------
Liabilities and stockholders' deficit $ 93,144 $146,702
======== ========