Antares Pharma Inc : Antares Pharma Reports Second Quarter 2012 Financial and Operating Results
08/08/2012| 07:05am US/Eastern

Recommend:
VIBEX? MTX Actual Human Use Study Complete - On Track for NDA Filing
in Q1 2013
Antares Pharma, Inc. (NASDAQ: ATRS) today reported financial and
operating results for the second quarter ended June 30, 2012.
Quarter and Recent Highlights
-
Completed the VIBEX? MTX Actual Human Use study. Results from this
study will be available early in the fourth quarter. The New Drug
Application (NDA) filing remains on track for first quarter 2013 as
all studies necessary for the completion of the NDA are now fully
enrolled.
-
Announced positive results from the VIBEX? MTX human factors usability
study. The study demonstrated that lay caregivers, healthcare
professionals and rheumatoid arthritis patients with severe to very
severe hand function impairment could administer simulated injections
successfully with our VIBEX? device.
-
Announced in April the launch of Gelnique 3%? for the treatment of
overactive bladder by our partner Watson as well as the settlement of
the epinephrine auto-injector litigation between Pfizer and our
partner Teva.
-
Increased total revenue 28% and 60% to $4.5 million and $11.4 million
in the three and six month periods ended June 30, 2012, respectively,
from $3.5 million and $7.1 million, respectively, in the comparable
periods of the prior year.
-
Ended the quarter with approximately $33 million in cash and
investments and no debt.
-
Moved stock exchange listing to NASDAQ from NYSE Amex effective June
15, 2012.
-
Expanded the senior management team with the addition of two seasoned
pharmaceutical professionals to key executive positions within the
organization and moved to a new corporate headquarters.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated,
"The Company continues to make excellent progress toward the VIBEX MTX
NDA filing. Our development team has worked diligently to complete
enrollment in all of the FDA agreed upon studies necessary to complete
the application. We have also made further progress on the VIBEX QST
product for male testosterone deficiency." Dr. Wotton continued, "While
much of our focus this quarter has been on the VIBEX MTX development
program, we also announced continued quarterly revenue growth as
compared to the same period last year, increased investment in our
pipeline, a move to the NASDAQ Stock Market in mid-June and continued
progress toward becoming a fully integrated pharmaceutical company with
the hiring of two key executives and a move to a new corporate
headquarters."
Second Quarter and First Half Results
Total revenues were $4.5 million and $3.5 million for the three months
ended June 30, 2012 and 2011, respectively, an increase of 28%. For the
six months ended June 30, 2012, the Company's total revenue increased to
$11.4 million, or 60%, from $7.1 million in the first six months of
2011. Product sales were $3.2 million in the second quarter of 2012
compared to $2.2 million in 2011, an increase of 45%. For the six months
ended June 30, 2012, product sales increased 57% to $5.7 million
compared to $3.6 million in the prior year. The product sales increases
were primarily due to sales of our oxybutynin gel 3% product to Watson
in connection with Watson's launch of Gelnique 3% in April 2012.
Development revenues were $0.7 million in each of the three month
periods ended June 30, 2012 and 2011. For the six months ended June 30,
2012, the Company's development revenue increased to $3.7 million from
$1.8 million in the first six months of 2011. The revenue in the first
half of 2012 was primarily due to revenue recognized in connection with
our license agreement with Watson along with development revenue from
Teva, while the development revenue in the first half of 2011 consisted
primarily of auto injector and pen injector development work for Teva.
Licensing revenues were $0.1 million in each of the three month periods
ended June 30, 2012 and 2011. For the first half of 2012 licensing
revenues were $0.7 million compared to $0.5 million in the first half of
2011. Licensing revenue in the first half of 2012 was primarily due to
an upfront fee received in connection with our licensing agreement with
Daewoong Pharmaceuticals for our 3% oxybutynin gel for South Korea,
along with license revenue recognized in connection with our license
agreement with Watson. Licensing revenue in the first half of 2011 was
primarily related to Teva agreements.
Royalty revenues were $0.5 million in each of the three month periods
ended June 30, 2012 and 2011, and were $1.2 million in each of the six
month periods ended June 30, 2012 and 2011. We receive royalties from
Teva and Ferring related to needle-free injector device sales and/or hGH
sales. We also receive royalties on sales of Elestrin®
marketed by Jazz Pharmaceuticals and will begin receiving royalties in
the third quarter of 2012 from Watson on sales of both Gelnique 3% and
Gelnique 10%.
Total gross profit was $2.0 million and $2.1 million in the second
quarters of 2012 and 2011, respectively, and increased to $6.9 million
for the first half of 2012 compared to $4.3 million for the first half
of 2011. The increase in the first half of 2012 was mainly a result of
an increase in development revenue.
Total operating expenses were approximately $4.8 million and $3.7
million for the three months ended June 30, 2012 and 2011, respectively,
and were $9.8 million and $7.3 million for the six months ended June 30,
2012 and 2011, respectively. The increases were primarily due to
increased investment related to development of our proprietary Vibex?
MTX auto injector for delivery of methotrexate for the treatment of
rheumatoid arthritis, along with an increase in personnel to support our
growing pharmaceutical business.
Net loss per share was $0.03 and $0.02 for the second quarters of 2012
and 2011, respectively, and was $0.03 for the six month periods of 2012
and 2011.
At June 30, 2012, Antares had approximately $33.0 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, EVP, CFO and President of the Parenteral Products Group, will
provide a company update and review second quarter 2012 results via
webcast and conference call on Wednesday, August 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
1-800-762-8779 (US), or 1-480-629-9722 (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 August
22, 2012. To access the replay, callers should dial 1-800-406-7325 (US)
or 1-303-590-3030 (International) and enter passcode 4555567.
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) marketed by Watson Pharmaceuticals, Inc. in the
U.S. 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 Group 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 Group 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, difficulties or
delays in the progress or completion 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)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
2012
|
|
2011
|
|
Assets
|
|
|
|
Cash and investments
|
|
$
|
33,017
|
|
$
|
34,396
|
|
Accounts receivable
|
|
|
2,630
|
|
|
2,535
|
|
Patent rights
|
|
|
1,044
|
|
|
952
|
|
Goodwill
|
|
|
1,095
|
|
|
1,095
|
|
Other assets
|
|
|
4,762
|
|
|
2,985
|
|
Total Assets
|
|
$
|
42,548
|
|
$
|
41,963
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
4,739
|
|
$
|
4,364
|
|
Deferred revenue
|
|
|
3,440
|
|
|
6,455
|
|
Stockholder's equity
|
|
|
34,369
|
|
|
31,144
|
|
Total Liabilities and Stockholders' Equity
|
|
$
|
42,548
|
|
$
|
41,963
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA, INC.
|
|
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
|
|
(amounts in thousands except per share amounts)
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
|
|
For the Six Months Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
Product sales
|
|
$
|
3,212
|
|
|
$
|
2,219
|
|
|
$
|
5,706
|
|
|
$
|
3,624
|
|
|
Development revenue
|
|
|
737
|
|
|
|
716
|
|
|
|
3,723
|
|
|
|
1,772
|
|
|
Licensing revenue
|
|
|
109
|
|
|
|
119
|
|
|
|
735
|
|
|
|
485
|
|
|
Royalties
|
|
|
466
|
|
|
|
489
|
|
|
|
1,224
|
|
|
|
1,231
|
|
|
Total Revenue
|
|
|
4,524
|
|
|
|
3,543
|
|
|
|
11,388
|
|
|
|
7,112
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
2,531
|
|
|
|
1,393
|
|
|
|
4,521
|
|
|
|
2,846
|
|
|
Gross Profit
|
|
|
1,993
|
|
|
|
2,150
|
|
|
|
6,867
|
|
|
|
4,266
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,483
|
|
|
|
1,946
|
|
|
|
5,360
|
|
|
|
3,696
|
|
|
Sales, marketing and business development
|
|
|
420
|
|
|
|
523
|
|
|
|
855
|
|
|
|
812
|
|
|
General and administrative
|
|
|
1,881
|
|
|
|
1,277
|
|
|
|
3,539
|
|
|
|
2,766
|
|
|
Total Operating Expenses
|
|
|
4,784
|
|
|
|
3,746
|
|
|
|
9,754
|
|
|
|
7,274
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(2,791
|
)
|
|
|
(1,596
|
)
|
|
|
(2,887
|
)
|
|
|
(3,008
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income and expenses
|
|
|
(16
|
)
|
|
|
42
|
|
|
|
6
|
|
|
|
73
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,807
|
)
|
|
$
|
(1,554
|
)
|
|
$
|
(2,881
|
)
|
|
$
|
(2,935
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.03
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.03
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average common shares outstanding
|
|
|
104,552
|
|
|
|
95,157
|
|
|
|
104,105
|
|
|
|
90,464
|
|
|
|
|
|
|
|
|
|
|
|

Antares Pharma, Inc.
Jack Howarth
Vice President, Corporate
Affairs
609-359-3016
jhowarth@antarespharma.com
© Business Wire 2012
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