Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial
and operating results for the first quarter ended March 31,
2012.
Quarter and Recent Highlights
- Increased total revenue 92% and product
revenue 78% to $6.9 million and $2.5 million, respectively, in the
first quarter of 2012 compared to $3.6 million and $1.4 million,
respectively, in the first quarter of 2011.
- Ended the quarter with $33.2 million in
cash and investments and no debt.
- Announced, along with our partner
Watson, the launch of Gelnique 3%™ for the treatment of overactive
bladder (OAB). Watson will detail Gelnique 3% to physicians with
their well-established commercial team focused on urology.
- Entered into a licensing agreement with
Daewoong Pharmaceuticals Co. Ltd. for South Korean marketing rights
for our topical oxybutynin gel 3% product receiving an upfront
payment and potential regulatory and sales-based milestones as well
as royalties on net sales of the product.
- Announced the settlement of the
epinephrine auto-injector litigation between our partner Teva and
Pfizer, and executed a separate agreement under which Teva has
agreed to provide us with device orders in 2013 and 2014 as well as
a milestone payment upon FDA approval of the product.
- Continued to advance our Vibex™ MTX
development program for the treatment of rheumatoid arthritis, and
remain on track to file a New Drug Application (NDA) with the FDA
in the first quarter of 2013.
“We are very pleased with both our first quarter financial and
operational results,” said Paul K. Wotton, Ph.D., President and
Chief Executive Officer. “The recent announcement of the commercial
availability of Gelnique 3% is further confirmation of the
Company’s ability to move drug/device products through the FDA
approval process and then oversee the timely completion of
production quantities for distribution and launch.”
Dr. Wotton continued, “On the product development front, we
successfully initiated Vibex MTX studies during the first quarter
under a previously agreed upon development strategy with the FDA.
We remain on track for completion of these studies and anticipate a
first quarter 2013 NDA filing. As these studies progress, we will
continue to explore global partnership opportunities in order to
enhance the commercial value of this proprietary product.”
First Quarter Financial Results
Total revenues were $6.9 million and $3.6 million for the three
months ended March 31, 2012 and 2011, respectively. Product sales
increased in the first quarter of 2012 to $2.5 million compared to
$1.4 million in the prior year, primarily due to sales of our
oxybutynin gel 3% product to Watson in preparation for Watson’s
launch of Gelnique 3% in April 2012.
Development revenues were $3.0 million and $1.1 million for the
three months ended March 31, 2012 and 2011, respectively. The
development revenue in the first quarter of 2012 was primarily due
to revenue recognized in connection with our license agreement with
Watson, while the development revenue in the first quarter of 2011
was primarily due to auto injector and pen injector development
work for Teva.
Licensing revenue was $0.6 million and $0.4 million for the
three months ended March 31, 2012 and 2011, respectively. Licensing
revenue in the first quarter of 2012 was primarily due to an
upfront fee received in connection with our licensing agreement
with Daewoong. Licensing revenue in the first quarter of 2011 was
primarily related to Teva agreements.
Revenue from royalties was $0.8 million and $0.7 million for the
three months ended March 31, 2012 and 2011, respectively. Royalties
were primarily due to royalties received from Teva on sales of
their hGH Tev-Tropin®.
Total gross profit increased in the first quarter of 2012 to
$4.9 million compared to $2.1 million in 2011. The increase in the
quarter was primarily due to a milestone payment from Watson
received and deferred in December 2011 that was recognized as
development revenue in the first quarter of 2012.
Total operating expenses were approximately $5.0 million and
$3.5 million for the first quarters of 2012 and 2011, respectively.
The increase was primarily due to an increase in research and
development expenses associated with our Vibex™ MTX development
program.
Net loss was approximately $0.1 million and $1.4 million for the
first quarters of 2012 and 2011, respectively, and net loss per
share was $0.00 and $0.02 in the first quarters of 2012 and 2011,
respectively.
At March 31, 2012, Antares had approximately $33.2 million in
cash and investments, compared to approximately $34.4 million at
December 31, 2011.
Conference Call, Call Replay and Webcast
Dr. Paul K. Wotton, President and Chief Executive Officer, and
Robert F. Apple, Executive Vice President, Chief Financial Officer,
and President of the Parenteral Products Division will provide a
company update and review first quarter 2012 results via webcast
and conference call on Tuesday, May 8, 2012, at 8:30 a.m. Eastern
Daylight Time (EDT). A webcast of the call will be available from
the investors/media section of the Company's web site at
www.antarespharma.com. Alternatively, callers may participate in
the conference call by dialing 1-877-941-8631 (US), or
1-480-629-9723 (International). Participants should reference the
Antares Pharma conference call. Webcast and telephone replays of
the conference call will be available approximately two hours after
the completion of the call through 12 p.m. EDT on May 22, 2012. To
access the replay, callers should dial 1-800-406-7325 (US) or
1-303-590-3030 (International) and enter passcode 4534582.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products
and topical gel-based medicines. The Company's subcutaneous and
intramuscular injection technology platforms include Vibex™
disposable pressure-assisted auto injectors, disposable multi-use
pen injectors and Vision™ reusable needle-free injectors marketed
as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva)
and Ferring Pharmaceuticals (Ferring), respectively. In the
injector area, Antares Pharma has a multi-product deal with Teva
that includes Tev-Tropin® human growth hormone (hGH) and a
partnership with Ferring that includes Zomacton® hGH. In the
gel-based area, the Company's FDA approved product is Gelnique 3%™
for the treatment of OAB (overactive bladder) which has been
licensed to Watson Pharmaceuticals, Inc. for marketing in the U.S.
and Canada. Antares’ portfolio includes Elestrin® (estradiol gel)
indicated for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause, and marketed in the U.S. by
Jazz Pharmaceuticals. Antares Pharma has two facilities in the U.S.
The Parenteral Products Division located in Minneapolis, Minnesota
directs the manufacturing and marketing of the Company’s reusable
needle-free injection devices and related disposables, and develops
its disposable pressure-assisted auto injector and pen injector
systems. The Company’s corporate offices and Pharma Division are
located in Ewing, New Jersey, where pharmaceutical products are
developed utilizing both the Company’s transdermal systems and
drug/device combination products.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
include statements related to the Company’s future financial
performance, and other statements which are other than statements
of historical facts. Such forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially
from those anticipated by the forward-looking statements. These
risks and uncertainties include, among others, changes in revenue
growth, difficulties or delays in the initiation, progress, or
completion of product development, clinical trials, or in the
progress of Vibex MTX product development or in the success of the
potential Vibex MTX NDA. Additional information concerning these
and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements
is contained in the "Risk Factors" section of the Company's Annual
Report on Form 10-K for the year ended December 31, 2011, and in
the Company's other periodic reports and filings with the
Securities and Exchange Commission. The Company cautions investors
not to place undue reliance on the forward-looking statements
contained in this press release. All forward-looking statements are
based on information currently available to the Company on the date
hereof, and the Company undertakes no obligation to revise or
update these forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by law.
TABLES FOLLOW
ANTARES PHARMA, INC. CONSOLIDATED CONDENSED
BALANCE SHEETS (amounts in thousands) March
31, December 31, 2012 2011 Assets
Cash and investments $ 33,200 $ 34,396 Accounts receivable 1,409
2,535 Patent rights 977 952 Goodwill 1,095 1,095 Other assets
4,046 2,985 Total Assets $ 40,727 $ 41,963
Liabilities and Stockholders’ Equity Accounts payable and
accrued expenses $ 4,664 $ 4,364 Deferred revenue 3,968 6,455
Stockholder’s equity 32,095 31,144 Total Liabilities
and Stockholders’ Equity $ 40,727 $ 41,963
ANTARES
PHARMA, INC. CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS (amounts in thousands except share amounts)
For the Three Months Ended March 31,
2012 2011 Product sales $ 2,494 $ 1,405
Development revenue 2,986 1,056 Licensing revenue 626 366 Royalties
759 742 Total Revenue 6,865 3,569
Cost of revenue 1,991 1,453
Gross Profit 4,874 2,116 Research and development 2,877
1,749 Sales, marketing and business development 436 289 General and
administrative 1,658 1,490 Total
Operating Expenses 4,971 3,528
Operating loss (97 ) (1,412 ) Other income and expenses
23 31 Net loss $ (74 ) $ (1,381
) Basic and diluted net loss per common share $ (0.00 ) $
(0.02 ) Basic and diluted weighted average common shares
outstanding 103,659 85,720
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