-- We have enrolled over 1,000 patients in the entire Dupuytren's
contracture clinical program, including over 900 patients in the four
ongoing phase III trials (CORD I and II and JOINT I and II). Over 2,000
injections of XIAFLEX have been given in all Dupuytren's trials conducted
to date.
-- We expect to begin our phase IIb study of XIAFLEX in Peyronie's
disease later this quarter.
-- In the first quarter of 2008, the Company began exploring partnering
opportunities for XIAFLEX as part of its ongoing evaluation of options to
maximize the product's potential in Europe.
TESTIM:
-- According to IMS, 120.500 total prescriptions for Testim were
dispensed in the first quarter of 2008, a growth of 31.2% over the first
quarter of 2007 and our highest quarterly level.
-- Testim continued to gain market share in the U.S., ending the month of
March with a 21.9% share of total prescriptions for testosterone gels, up
from 18.9% at the end of March 2007, according to IMS.
-- Total prescriptions within the gel segment of the testosterone
replacement therapy market in the U.S. grew 12.9% versus the first quarter
of 2007, according to IMS.
-- We have begun to enroll sites into our TRiUS Testim registry in the
U.S. to evaluate short and long term outcomes of testosterone replacement
therapy (TRT).
-- On January 22, 2008, the U.S. Patent and Trademark Office issued U.S.
Patent No. 7,320,968 covering Testim®, which the Company licenses from
Bentley Pharmaceuticals, Inc. The patent expires in January 2025 and has
been listed in Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the Orange Book), published by the FDA.
MANAGEMENT TEAM ADDITIONS:
-- In the first quarter of 2008, the Company continued to build out its
management team with seasoned executives.
-- Mr. Will Sargent joined as Vice President, Investor Relations and
Corporate Communications. Mr. Sargent will be the principal point of
contact with the investment community and will manage internal and
external communications for the Company. Mr. Sargent joined Auxilium
after covering the biotech industry for the last three years as an
equity research analyst for Banc of America Securities. Prior to
that, Mr. Sargent held marketing and development positions with Amgen
and Immunex. He received his undergraduate degree from the Johns
Hopkins University and received an MBA from the University of
Washington.
-- Dr. Laura Offutt joined as Vice President, Medial Affairs. Dr.
Offutt will be responsible for providing medical support for the
Testim brand. Dr. Offutt comes to us from Wyeth Research where she
was part of the clinical team in neuroscience. She previously held
positions in the Global Safety Surveillance and Epidemiology group at
Wyeth. Dr. Offutt graduated from Columbia University and received her
medical degree from Northwestern followed by a medical residency at
Jefferson Medical College. She is board certified in internal
medicine.
First Quarter 2008 Financial Detail
For the quarter ended March 31, 2008, Auxilium reported net revenues of
$27.1 million compared to net revenues of $18.4 million in the first
quarter of 2007. Total Testim units reported by IMS on a prescription
basis exceeded total Testim units sold to our customers during the first
quarter of 2008. We have estimated this shortfall in sales during the
quarter to be approximately $1.3 million in net revenues. There were no
shipments of Testim to our ex-U.S. partners in the first quarter of 2008,
compared to $0.3 million of shipments to these partners in the first
quarter of 2007. The net loss for the first quarter of 2008 was $(12.3)
million, or $(0.30) per share, compared to a net loss of $(11.9) million,
or $(0.33) per share, reported for the first quarter of 2007. Net loss for
the first quarter of 2008 includes total stock-based compensation expense
of $2.1 million, compared to $1.2 million for the first quarter of 2007.
Gross margin on net revenues was 77.9% for the quarter ended March 31, 2008
compared to 72.4% for the comparable period in 2007. Gross margin reflects
the cost of product sold as well as royalty payments made to the Company's
licensor on the sales of Testim. The increase in the gross margin rate
reflects the impact of year-over-year price increases on U.S. Testim
revenues, the decline in lower margin international product shipments, the
benefit of a one-time manufacturing fee rebate and the lack of expenses
related to Testim manufacturing and quality improvement programs carried
out in the first quarter of 2007.
Research and development spending for the quarter ended March 31, 2008 was
$13.2 million, compared to $8.7 million for 2007. The increase in
research and development costs was primarily due to the increased spending
for development and manufacturing for XIAFLEX.
Selling, general and administrative expenses totaled $21.0 million for the
quarter ended March 31, 2008 compared with $17.2 million for the year-ago
quarter. The increase was primarily due to higher investment in promotional
spending for Testim,
pre-launch investments in market research and incremental personnel for
XIAFLEX, and higher stock-based compensation expense.
As of March 31, 2008, Auxilium had $56.9 million in cash and cash
equivalents compared to $70.3 million on December 31, 2007.
Conference Call
Auxilium will hold a conference call today, April 30, 2008 at 10:00 a.m.
ET, to discuss first quarter 2008 results and operational highlights. The
conference call will be simultaneously web cast on Auxilium's web site and
archived for future review until May 30, 2008.
Conference call details: Date: Wednesday, April 30, 2008 Time: 10:00 a.m. ET Dial-in (U.S.): 866.202.4683 Dial-in (International): 617.213.8846 Password: AUXILIUM Web cast: http://www.auxilium.com To access an audio replay of the call: Access number (U.S.): 888-286-8010 Access number (International): 617-801-6888 Conference ID#: 42186535About Auxilium Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical development. XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder syndrome (Adhesive Capsulitis). The Company is currently seeking a partner to commercialize XIAFLEX for Dupuytren's contracture and Peyronie's disease in the EU. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. Auxilium's transmucosal film product candidate for the treatment of overactive bladder is in phase I of development. The Company is currently seeking a partner to further develop this product candidate. Auxilium has one pain product using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to seven additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. For additional information, visit http://www.auxilium.com. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 In addition to historical facts or statements of current condition, this release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding
-- the number of patients dosed with XIAFLEX that will be required to
fulfill the safety data requirements for filing a Biologics License
Application with the U.S. Food and Drug Administration;
-- the timing of the release of top-line results from the CORD I and II
trials for XIAFLEX for the treatment of Dupuytren's contracture;
-- the commencement of a phase IIb clinical study for XIAFLEX for the
treatment of Peyronie's disease;
-- the protection for Testim afforded by U.S. Patent No. 7,320,968 and
its listing in the Orange Book;
-- the value and potential impact of the Company's partnering opportunity
for XIAFLEX in Europe, should it occur;
-- the impact of recent additions to the management team.
Forward-looking statements often address Auxilium's expected future
financial position or business strategy and plans and objectives of
management for future operations, and often contain the words "believe,"
"may," "could," "will," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "expect," and "potentially," and similar expressions.
Forward-looking statements provide Auxilium's current expectations or
forecasts of future events. Auxilium's performance and financial results
could differ materially from those reflected in these forward-looking
statements due to:
-- the success of research and development activities;
-- the performance of third-party manufacturers and suppliers;
-- decisions by regulatory authorities as to whether and when to approve
drug applications;
-- decisions by regulatory authorities as to whether and when to proceed
to the next phase of clinical trials;
-- difficulties or delays in manufacturing;
-- competition from currently marketed products, generic products, and
new products;
-- legislative and regulatory action in the jurisdictions in which
Auxilium markets or seeks to market its products;
-- claims and concerns that may arise regarding the safety or efficacy of
its products; and
-- increase in costs or expenses.
A more detailed list and description of the risks and uncertainties that
Auxilium faces may be found under the heading "Risk Factors" in Auxilium's
Annual Report on Form 10-K for the year ended December 31, 2007 which is
on file with the Securities and Exchange Commission. Given these risks and
uncertainties, any or all of the forward-looking statements contained in
this release may prove to be incorrect. Therefore, you should not rely on
any such factors or forward-looking statements. Auxilium undertakes no
obligation to update publicly any forward-looking statement.
AUXILIUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
March 31,
2008 2007
------------ ------------
Net revenues $ 27,117 $ 18,420
------------ ------------
Operating expenses:
Cost of goods sold 5,999 5,078
Research and development* 13,191 8,711
Selling, general, and administrative* 21,020 17,207
------------ ------------
Total operating expenses 40,210 30,996
------------ ------------
Loss from operations (13,093) (12,576)
Interest income (expense), net 779 702
Other income (expense), net - (3)
------------ ------------
Net loss $ (12,314) $ (11,877)
============ ============
Basic and diluted net loss per common share $ (0.30) $ (0.33)
============ ============
Weighted average common shares outstanding 40,670,290 35,778,015
============ ============
*includes the following amounts of stock-based
compensation expense:
Research and development $ 516 $ 222
Selling, general and administrative 1,597 959
Condensed Balance Sheets
(In thousands)
(Unaudited)
March 31, December 31,
2008 2007
------------ ------------
Cash and cash equivalents $ 56,897 $ 70,290
Short term investments - 5,800
Working capital 49,686 64,861
Long-term investments 5,800 -
Total assets 98,879 106,979
Long-term liabilities 11,163 11,166
Total stockholders' equity 54,774 64,016
Contact Information: For More Information, Contact: James E. Fickenscher Chief Financial Officer Auxilium Pharmaceuticals, Inc. +1-484-321-5900 William Q. Sargent Jr. Vice-President, Investor Relations and Corporate Communications +1-484-321-5900