Web Cast Scheduled for Today at 8:30 a.m. ET
MALVERN, PA, Jul 12, 2010 (MARKETWIRE via COMTEX) --
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) today announced that
XIAFLEX(R) net revenues were $3.1 million for the second quarter
2010, consisting of $2.0 million in sales to physicians in the United
States and $1.1 million in revenues recognized from payments
previously received under the Pfizer agreement.
"Having completed the first full quarter of the launch of XIAFLEX,
the first approved, non-surgical treatment for the treatment of
Dupuytren's contracture, we believe that we are making good progress
on our launch objectives as we work to change the treatment paradigm
for this disease," said Armando Anido, Chief Executive Officer and
President of Auxilium.
The Company also updated the following leading indicators which it
tracks in connection with the XIAFLEX launch. As of June 30, 2010:
-- 1,629 physicians and 1,122 sites have completed the training and
enrollment process, compared to 1,421 and 962, respectively, at the
end of May.
-- A total of 1,458 insurance verification requests and 543 referrals to
specialty pharmacies have been received by the Company's call center,
up from 886 and 336, respectively, at the end of May.
-- The number of cumulative, unique sites ordering XIAFLEX for the first
time is 241 compared to 138 sites at the end of May.
-- The Company believes that approximately 90% of insured lives in the
United States have access to XIAFLEX.
In addition, the Company announced that it held its end of phase II
meeting with the U.S. Food and Drug Administration in late June 2010
regarding development of XIAFLEX for the treatment of Peyronie's
disease and that, as a result, the Company is reaffirming its plan to
initiate phase III pivotal trials by the end of 2010.
Mr. Armando Anido, Chief Executive Officer and President, will
provide a launch and development update on XIAFLEX today, Monday,
July 12, 2010 at 8:30 a.m. ET. Dr. Clayton Peimer, Clinical Professor
of Orthopedics at Michigan State University and attending hand
surgeon at Marquette General Health System, will also present during
the call. The presentation slides to be used during the call are now
available on the "For Investors" section of the Auxilium web site
under the "Presentations" tab. A web cast of the conference call and
the presentation slides will be available on the "For Investors"
section of the Auxilium web site under the "Events" tab beginning at
8:30 a.m. ET on Monday, July 12, 2010. A question and answer session
will follow the presentations.
Conference call details:
Date: Monday, July 12, 2010
Time: 8:30 a.m. ET
Dial-in (U.S.): 866-362-4831
Dial-in (International): 617-597-5347
Web cast and slides: http://ir.auxilium.com/
Passcode: AUXILIUM
To access an audio replay of the call:
Access number (U.S.): 888-286-8010
Access number (International): 617-801-6888
Replay Passcode #: 14203618
To listen to the audio web cast of the presentation during or after
the event, please visit: http://www.auxilium.com. The replay will be
available for ninety days after the event.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing products to
predominantly specialist audiences, such as urologists,
endocrinologists, certain targeted primary care physicians, hand
surgeons, subsets of orthopedic, general, and plastic surgeons who
focus on the hand, and rheumatologists. Auxilium markets XIAFLEX(R)
(collagenase clostridium histolyticum) for the treatment of adult
Dupuytren's contracture patients with a palpable cord and Testim(R)
1%, a topical testosterone gel, for the treatment of hypogonadism.
Auxilium has four projects in clinical development. XIAFLEX is in
phase IIb of development for the treatment of Peyronie's disease and
is in phase II of development for treatment of Frozen Shoulder
syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product
candidate for the treatment of overactive bladder (AA4010) and its
fentanyl pain product using its transmucosal delivery system are in
phase I of development. The Company is currently seeking a partner to
further develop these product candidates. Auxilium has rights to
additional pain products and products for hormone replacement and
urologic disease using its transmucosal film delivery system.
Auxilium also has options to all indications using XIAFLEX for
non-topical formulations. For additional information, visit
http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This release contains "forward-looking-statements" within the meaning
of The Private Securities Litigation Reform Act of 1995, including
statements regarding the Company's progress toward achievement of its
objectives for the U.S. launch of XIAFLEX for Dupuytren's in 2010;
the percentage of insured lives in the U.S. with access to XIAFLEX;
the effect of the identified leading indicators on the success of the
XIAFLEX launch and future net revenues; the timing of initiation of
phase II trials for XIAFLEX for the treatment of Peyronie's disease;
and products in development for Peyronie's disease, Frozen Shoulder
syndrome, overactive bladder, pain, hormone replacement and urologic
disease; and all other statements containing projections, statements
of future performance or expectations, our beliefs or statements of
plans or objectives for future operations (including statements of
assumption underlying or relating to any of the foregoing).
Forward-looking statements can generally be identified by words such
as "believe," "appears," "may," "could," "will," "estimate,"
"continue," "anticipate," "intend," "should," "plan," "expect," and
other words and terms of similar meaning in connection with any
discussion of projections, future performance or expectations,
beliefs, plans or objectives for future operations (including
statements of assumption underlying or relating to any of the
foregoing). Actual results may differ materially from those reflected
in these forward-looking statements due to various factors, including
further evaluation of clinical data, results of clinical trials,
decisions by regulatory authorities as to whether and when to approve
drug applications, and general financial, economic, regulatory and
political conditions affecting the biotechnology and pharmaceutical
industries and those discussed in Auxilium's Annual Report on Form
10-K for the year ended December 31, 2009 and in Auxilium's Quarterly
Report on Form 10-Q for the period ended March 31, 2010 under the
heading "Risk Factors," which are on file with the Securities and
Exchange Commission (the "SEC") and may be accessed electronically by
means of the SEC's home page on the Internet at http://www.sec.gov or
by means of Auxilium's home page on the Internet at
http://www.Auxilium.com under the heading "For Investors -- SEC
Filings." There may be additional risks that Auxilium does not
presently know or that Auxilium currently believes are immaterial
which could also cause actual results to differ from those contained
in the forward-looking statements. Given these risks and
uncertainties, any or all of these forward-looking statements may
prove to be incorrect. Therefore, you should not rely on any such
factors or forward-looking statements.
In addition, forward-looking statements provide Auxilium's
expectations, plans or forecasts of future events and views as of the
date of this release. Auxilium anticipates that subsequent events and
developments will cause Auxilium's assessments to change. However,
while Auxilium may elect to update these forward-looking statements
at some point in the future, Auxilium specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing Auxilium's assessments as of any date
subsequent to the date of this release.
For More Information, Contact:
James E. Fickenscher
CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact
William Q. Sargent, Jr.
V.P., IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact
SOURCE: Auxilium Pharmaceuticals, Inc.
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