Full Year 2009 Net Revenues Increase by 30.8% to a Record $164.0 Million; 2010 Testim(R) Revenues Expected to Be in the Range of $185 Million to $195 Million; XIAFLEX(TM) List Price to Distributors Will Be $3,250.00 per Vial
XIAFLEX:
-- On February 2, 2010, the Company received approval for XIAFLEX for
treatment of adult Dupuytren's contracture patients with a palpable
cord from the U.S. Food and Drug Administration (FDA).
-- In its September 3rd edition, The New England Journal of Medicine
published data from the pivotal CORD I phase III clinical trial of
XIAFLEX, which is the largest, prospective, double blind, placebo
controlled clinical trial ever conducted in the field of Dupuytren's
contracture.
-- In January 2010, the Company and its European commercialization
partner, Pfizer Inc., announced the European Union's
scientific/technical review procedure for the Marketing
Authorization Application for XIAFLEX for the treatment of
Dupuytren's contracture commenced. As a result of accomplishing
this milestone, the Company has received $15 million from Pfizer.
-- In December 2009, the Company reported results of its Phase IIb
study in Peyronie's disease. Overall, XIAFLEX demonstrated a
statistically significant change compared to placebo at 36 weeks in
both improvement in penile curvature (p=0.001) and the Patient
Reported Outcome (PRO) Peyronie's disease bother domain (p=0.046).
XIAFLEX was well-tolerated and the most common treatment related
adverse events in the phase IIb study were consistent with adverse
events reported in previous Peyronie's disease trials with XIAFLEX,
which included injection site bruising, edema and pain.
TESTIM:
-- Worldwide revenues for Testim were $160.4 million, up 28.1%
over 2008.
-- Testim U.S. revenues were up 23.2% over the prior year to a record
$151.9 million.
-- Testim prescriptions grew by 14.9% over 2008 according to National
Prescription Audit data from IMS Health, Inc. (IMS), a leading
market research firm.
-- Total prescriptions for the testosterone replacement gel market
segment grew 14.9% in 2009 according to data from IMS.
-- The FDA response to the Company's Citizen's Petition was received
in August 2009. The FDA agreed with some of the statements made in
the Citizen's Petition regarding the testing required for generic
versions of Testim and disagreed with other statements. Although
not commenting upon any filing in particular, the FDA did state
that "the practical effect of this determination is that any
application for a testosterone gel product that has different
penetration enhancers than the reference listed drug cannot be
submitted as an abbreviated new drug application (ANDA) and,
instead, will have to be submitted as a NDA under section 505(b)
of the Act."
-- In October 2009, six additional U.S. Patents (# 7,608,605 through
610) covering method of use claims for Testim were issued to CPEX
Pharmaceuticals, Inc. and expire in 2023.
-- In the fourth quarter of 2009, the Company successfully completed
transferring all existing European Marketing Authorizations related
to Testim to its European partner for Testim, Ferring
International S.A.
COMPANY HIGHLIGHTS:
-- Auxilium was named the Silver Winner in the Large Company (101-1,000
employees) category in the 2009 Best Places to Work in Philadelphia
competition by The Philadelphia Business Journal.
-- The Company was recognized as a top fifteen finalist in Deloitte's
2009 Fast 50 program for the greater Philadelphia area.
OTHER EVENTS:
-- In September 2009, the Company completed the sale of 3.45 million
shares of its common stock at a price of $34.50 per share, resulting
in proceeds to the Company, net of offering expenses and underwriting
discounts and commissions, of approximately $115.8 million.
-- In August 2009, the Company secured a $30 million revolving credit
line from Silicon Valley Bank.
2010 Financial Guidance and Strategic Priorities
For 2010, Auxilium anticipates that:
-- Testim revenues will be in the range of $185 million to $195 million;
-- Research and development spending will be in the range of $50 million
to $60 million, which includes $5 million to $6 million of
stock-based compensation cost; and,
-- Selling, general and administrative expenses will be in the range of
$160 million to $170 million, which includes $17 million to $19
million of stock-based compensation cost.
Auxilium expects to execute on the following strategic priorities in 2010:
-- Execute the launch in the U.S. of XIAFLEX for Dupuytren's contracture
by the end of March;
-- Support Pfizer in the ongoing regulatory review of the XIAFLEX
European submission and prepare for the eventual launch in Europe
for Dupuytren's contracture;
-- Commence phase III for XIAFLEX in Peyronie's disease, assuming a
successful end-of-phase II meeting with the FDA in the second
quarter of 2010; and,
-- Continue to vigorously defend our Testim intellectual property.
Fourth Quarter 2009 Financial Detail
For the quarter ended December 31, 2009, Auxilium reported net revenues of
$48.0 million compared to net revenues of $34.8 million in the fourth
quarter of 2008, an increase of 38.1%. Sales of Testim in the U.S. were
$42.3 million, a 24.4% increase over the $34.0 million recognized in the
fourth quarter of 2008. There was $4.9 million of ex-U.S. partner
milestone revenue recognition and shipments of Testim in the fourth quarter
of 2009, compared to $0.7 million in the fourth quarter of 2008. Included
in this $4.9 million for 2009 is the $3.9 million remaining balance of
deferred milestone payments from Ipsen Pharma GmbH that were recognized as
revenue upon the completion of transferring all marketing authorizations in
Europe to our current Testim partner, Ferring International S.A. Fourth
quarter 2009 revenues also include $0.9 million in amortization of upfront
payments related to the out-licensing of XIAFLEX, compared to $0.1 million
in the fourth quarter of 2008.
The net loss for the fourth quarter of 2009 was $(11.9) million, or $(0.25)
per share, compared to a net loss of $(12.1) million, or $(0.29) per share,
reported for the fourth quarter of 2008. Net loss for the fourth quarter of
2009 includes total stock-based compensation expense of $4.4 million,
compared to $3.7 million for the fourth quarter of 2008.
Gross margin on net revenues was 78.3% for the quarter ended December 31,
2009 compared to 76.3% for the comparable period in 2008. The improvement
in gross margin reflects the increase in amortization of upfront and
milestone payments, including recognition of the remaining deferred
milestone payments from our former European Testim partner, and the impact
of year-over-year price increases, partially offset by increased low margin
international shipments.
Research and development spending for the quarter ended December 31, 2009
was $11.4 million, compared to $14.6 million for 2008. The reduction in
spending was the result of lower clinical development activity in XIAFLEX
for Dupuytren's contracture, and lower manufacturing development costs in
Horsham with the commencement of commercial production activity in 2009.
Selling, general and administrative costs for the quarter ended December
31, 2009 were $38.7 million, compared to $24.4 million in the comparable
2008 period. The increase was primarily due to investments in preparing
for the launch of XIAFLEX, higher compensation costs associated with
increased headcount and stock-based compensation expense and costs incurred
in defense of our Testim intellectual property.
As of December 31, 2009, Auxilium had $182.0 million in cash, cash
equivalents and short-term investments, compared to $192.3 million at
September 30, 2009.
Full Year 2009 Financial Detail
For the full year 2009, net revenues totaled $164.0 million, compared to
net revenues of $125.4 million for the year 2008, an increase of 30.8%.
Sales of Testim in the U.S. were $151.9 million, a 23.2% increase over the
$123.3 million recognized in 2008. There was $8.5 million of ex-U.S.
partner milestone revenue recognition and shipments of Testim in 2009,
compared to $1.9 million in 2008. Included in this $8.5 million for 2009
is the $6.4 million of previously deferred milestone payments from Ipsen
Pharma GmbH that were recognized as revenue in connection with the transfer
of the marketing authorizations in Europe to our current Testim partner,
Ferring International S.A. Revenues for 2009 also include $3.6 million in
amortization of upfront payments related to the out-licensing of XIAFLEX,
compared to $0.1 million in 2008.
Auxilium reported a net loss of $(53.5) million, or $(1.22) per share, for
the full year 2009, compared to a net loss of $(46.3) million, or $(1.12)
per share, for the full year 2008. Net loss for 2009 includes total
stock-based compensation expense of $17.9 million, compared to $11.7
million for the full year 2008.
Gross margin on net revenues was 77.4% for the full year 2009, compared to
76.5 % for the full year 2008.
Research and development costs for the full year 2009 were $51.4 million
compared with $54.5 million for the full year 2008.
Selling, general and administrative expenses totaled $129.2 million for the
year ended December 31, 2009, compared with $89.5 million for the year-ago
period.
Conference Call
Auxilium will hold a conference call today, February 17, at 10:00 a.m. ET,
to discuss fourth quarter and full year 2009 results, as well as the
financial and operational guidance it has provided for 2010 and the list
price per vial of XIAFLEX. The conference call will be simultaneously web
cast on Auxilium's web site and archived for future review until March 17,
2010.
Conference call details: Date: Wednesday, February 17, 2010 Time: 10:00 a.m. ET Dial-in (U.S.): 800-259-0251 Dial-in (International): 617-614-3671 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 #: 81525874About 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 XIAFLEX™ (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 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 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 2010, including
2010 Testim revenues, research and development spending, selling,
general and administrative expenses and stock-based compensation
expenses;
-- Auxilium's strategic priorities for 2010;
-- the timing of the launch of XIAFLEX for the treatment of
Dupuytren's contracture;
-- the potential for XIAFLEX to be a blockbuster opportunity that can
provide sustainable long-term growth for the Company;
-- the interpretation of clinical data from the Peyronie's phase IIb
trial and the ability and timing to commence phase III for XIAFLEX
for the treatment of Peyronie's disease;
-- the number of cords that Dupuytren's contracture patients treated
with XIAFLEX will have treated and the average number of vials of
XIAFLEX that will be used to treat each cord; and
-- the interpretation and impact of the FDA's response to the Company's
Citizen Petition.
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, suppliers and
licensees;
-- 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;
-- 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, in
Auxilium's Quarterly Report on Form 10-Q for the period ended June 30, 2009
and in Auxilium's Quarterly Report on Form 10-Q for the period ended
September 30, 2009 which are 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 Twelve Months Ended
December 31, December 31,
---------------------- ----------------------
2009 2008 2009 2008
---------- ---------- ---------- ----------
Net revenues $ 48,027 $ 34,775 $ 164,039 $ 125,377
---------- ---------- ---------- ----------
Operating expenses:
Cost of goods sold 10,416 8,257 37,077 29,486
Research and
development* 11,375 14,591 51,398 54,497
Selling, general and
administrative* 38,711 24,358 129,181 89,482
---------- ---------- ---------- ----------
Total operating
expenses 60,502 47,206 217,656 173,465
---------- ---------- ---------- ----------
Loss from operations (12,475) (12,431) (53,617) (48,088)
Interest income (expense),
net (38) 292 160 1,801
---------- ---------- ---------- ----------
Loss before income taxes (12,513) (12,139) (53,457) (46,287)
Provision for income taxes (614) - - -
---------- ---------- ---------- ----------
Net loss $ (11,899) $ (12,139) $ (53,457) $ (46,287)
========== ========== ========== ==========
Basic and diluted net loss
per common share $ (0.25) $ (0.29) $ (1.22) $ (1.12)
========== ========== ========== ==========
Weighted average common
shares outstanding 47,001,779 41,972,506 43,650,775 41,272,557
========== ========== ========== ==========
*includes the following
amounts of stock-based
compensation expense:
Research and
development $ 1,027 $ 1,084 $ 5,048 $ 3,140
Selling, general and
administrative 3,336 2,581 12,852 8,602
AUXILIUM PHARMACEUTICALS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
December 31, December 31,
2009 2008
------------ ------------
Cash and cash equivalents $ 181,977 $ 113,943
Total assets 260,564 171,187
Total stockholders' equity 120,519 35,266
Contact Information: For More Information, Contact: James E. Fickenscher CFO Auxilium Pharmaceuticals, Inc. (484) 321-5900 William Q. Sargent Jr. VP IR Auxilium Pharmaceuticals, Inc. (484) 321-5926