-- On February 27, the Company filed its BLA for Dupuytren's contracture
with FDA. The filing included data from 1,082 subjects and over 2,600
injections of XIAFLEX. FDA accepted the Company's BLA and granted Priority
review on April 28, 2009.
-- Key Commercial and Medical personnel have been added in anticipation
of a potential launch in the second half of 2009.
-- The Company enrolled over 120 patients in its phase IIb study of
XIAFLEX for Peyronie's disease on January 30, completed all dosing on April
30, and expects to announce top-line results in the fourth quarter of 2009.
TESTIM:
-- According to IMS, 138,164 total prescriptions for Testim were
dispensed in the first quarter of 2009, a growth of 14.1% over the first
quarter of 2008.
-- Total prescriptions within the gel segment of the testosterone
replacement therapy market in the U.S. grew 14.9% versus the first quarter
of 2008, according to IMS.
-- Testim ended the month of March with a 21.6% share of total
prescriptions for testosterone gels in the U.S., down from 21.9% at the end
of March 2008, according to IMS.
MANAGEMENT TEAM ADDITIONS:
-- In the first quarter of 2009, the Company continued to build out its
management team. Dr. Jim Tursi joined Auxilium as Vice President, Clinical
Affairs. Dr. Tursi was previously at GlaxoSmithKline Biologicals (GSK)
where he directed the cross-functional team preparing their cervical cancer
vaccine for launch in North America. Prior to GSK, he was Senior Medical
Director of Medical Affairs/Clinical Development at Procter and Gamble
Pharmaceuticals and had responsibility for Women's Health, Urology, and
Gastroenterology products. Dr. Tursi received his MD from the Medical
College of Pennsylvania and completed residency training in obstetrics and
gynecology at The Johns Hopkins Hospital.
Updated 2009 Financial and Operational Guidance
Based on the FDA's acceptance of the XIAFLEX BLA for Priority review,
Auxilium has updated its 2009 guidance. The Company is not including any
sales of XIAFLEX or the costs of the 75 to 100 person XIAFLEX sales force
that it anticipates hiring (including certain training and marketing costs)
in its updated guidance because the amount of such sales and costs that may
be realized in 2009, if any, are dependent upon the launch date of XIAFLEX
which is not yet known. The Company anticipates:
-- net revenues remain unchanged at $150 million to $155 million for
2009;
-- research and development investment will be in the range of $45
million to $50 million, which includes $4 million to $5 million of stock-
based compensation cost. This is down from previous guidance of $49
million to $53 million;
-- selling, general and administrative expenses will be in the range of
$120 million to $130 million up from previous guidance of $116 million to
$121 million, which does not include the costs of hiring and training the
sales force, and includes $12 million to $14 million of stock-based
compensation cost;
-- net loss will be in the range of $55 million to $60 million compared
to the previous guidance of $50 million to $55 million; and
-- total stock-based compensation expense will remain in the range of $16
million to $19 million.
With respect to the clinical and commercialization program for XIAFLEX,
Auxilium expects to:
-- prepare the Company's commercial organization to execute a successful
U.S. XIAFLEX launch within 60 days of the FDA's action date; and
-- release top-line results from the double-blind phase IIb clinical
trial for XIAFLEX for the treatment of Peyronie's in the fourth quarter of
2009.
Information concerning select assumptions will be discussed during the
conference call today, May 6, 2009 at 10:00 a.m. EDT.
First Quarter 2009 Financial Details
For the quarter ended March 31, 2009, Auxilium reported net revenues of
$34.7 million compared to net revenues of $27.1 million in the first
quarter of 2008. There was $1.3 million of ex-U.S. partner milestone
revenue recognition and shipments of Testim in the first quarter of 2009,
compared to $0.2 million of ex-U.S. partner milestone revenue recognition
in the first quarter of 2008. The Company also recognized $0.9 million in
revenues related to the amortization of upfront payments related to
XIAFLEX. The net loss for the first quarter of 2009 was $(13.2) million,
or $(0.31) per share, compared to a net loss of $(12.3) million, or $(0.30)
per share, reported for the first quarter of 2008. Net loss for the first
quarter of 2009 includes total stock-based compensation expense of $4.5
million, compared to $2.1 million for the first quarter of 2008.
Gross margin on net revenues was 77.3% for the quarter ended March 31, 2009
compared to 77.9% for the comparable period in 2008. 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 decrease in the gross margin rate is
the result of a 2008 one-time manufacturing fee rebate and higher coupon
usage in 2009, partially offset by the impact of year-over-year price
increases on U.S. Testim revenues and the increase in amortization of
upfront and milestone payments.
Research and development spending for the quarter ended March 31, 2009 was
$13.5 million, compared to $13.2 million for 2008. Although the overall
spending was comparable year over year, there was a significant reduction
in clinical development costs primarily related to fewer XIAFLEX related
clinical trials being conducted in 2009, offset by increases in regulatory
costs and manufacturing costs at our Horsham manufacturing facility.
Selling, general and administrative expenses totaled $26.4 million for the
quarter ended March 31, 2009 compared with $21.0 million for the year-ago
quarter. The increase was primarily due to higher compensation costs
associated with FAS 123R, costs incurred in defense of our Testim
intellectual property and investments in preparing for the potential U.S.
launch of XIAFLEX.
As of March 31, 2009, Auxilium had $90.2 million in cash and cash
equivalents compared to $113.9 million on December 31, 2008.
Conference Call
Auxilium will hold a conference call today, May 6, 2009 at 10:00 a.m. EDT,
to discuss first quarter 2009 results and operational highlights. The
conference call will be simultaneously web cast on Auxilium's web site and
archived for future review until June 6, 2009.
Conference call details: Date: Wednesday, May 6, 2009 Time: 10:00 a.m. EDT Dial-in (U.S.): 866-543-6411 Dial-in (International): 617-213-8900 Web cast: http://www.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 #: 69053857About 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 five projects in clinical development. XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500, has completed phase III clinical trials for the treatment of Dupuytren's contracture, and the biologics license application is under review at the FDA for the treatment of Dupuytren's contracture. 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 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:
-- Auxilium's expected financial performance during 2009 and the
financial milestones that it may achieve for 2009, including 2009 net
revenues, research and development spending, selling, general and
administrative expenses, net loss and stock-based compensation expenses;
-- the timing of the release of top-line results from the phase IIb
clinical trial for XIAFLEX for the treatment of Peyronie's disease;
-- the approval by FDA of the filing of the Biologics License Application
for XIAFLEX for the treatment of Dupuytren's contracture and the timing of
such approval;
-- the Company's preparedness for the launch of XIAFLEX in the U.S. and
the timing of such launch; and
-- the interpretation of clinical data.
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;
-- further evaluation of clinical data and results of clinical trials;
-- 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;
-- the timing, cost and degree of success of the U.S. launch of XIAFLEX;
-- difficulties or delays in manufacturing;
-- the outcome of pending litigation;
-- competition from currently marketed products, generic products, and
new products;
-- general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries and 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, 2008, 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 Statement of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
March 31,
----------------------
2009 2008
---------- ----------
Net revenues $ 34,674 $ 27,117
---------- ----------
Operating expenses:
Cost of goods sold 7,877 5,999
Research and development* 13,534 13,191
Selling, general and administrative* 26,403 21,020
---------- ----------
Total operating expenses 47,814 40,210
---------- ----------
Loss from operations (13,140) (13,093)
Interest income 220 779
---------- ----------
Loss before income taxes $ (12,920) $ (12,314)
Income tax expense 314 -
---------- ----------
Net loss $ (13,234) $ (12,314)
========== ==========
Basic and diluted net loss per
common share $ (0.31) $ (0.30)
========== ==========
Weighted average common shares
outstanding 42,320,072 40,670,290
========== ==========
*includes the following amounts
of stock-based compensation expense:
Research and development $ 1,132 $ 516
Selling, general and administrative 3,398 1,597
AUXILIUM PHARMACEUTICALS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
March 31, December 31,
2009 2008
---------- ----------
Cash and cash equivalents $ 90,195 $ 113,943
Working capital 74,407 87,339
Long-term investments 3,419 3,419
Total assets 150,525 171,187
Other long-term liabilities 78,218 80,423
Total stockholders' equity 26,998 35,266
Contact Information: CONTACT: James E. Fickenscher Chief Financial Officer Auxilium Pharmaceuticals, Inc. +1-484-321-5900 or William Q. Sargent Jr. Vice-President, Investor Relations and Corporate Communications +1-484-321-5900