Antares Pharma, Inc. (NASDAQ: ATRS) today reported operating and
financial results for the second quarter ended June 30, 2014.
Quarter and Recent Highlights
- Increased number of unique prescribers
of OTREXUP™ to over 600 total physicians as of June 30, 2014 and
dispensed approximately 5,000 prescriptions year-to-date, according
to Symphony Health Solutions.
- Reported total revenues of $6.3 million
for the second quarter of 2014, and $11.5 million year-to-date. Net
sales of OTREXUP based on patient prescriptions dispensed were $1.7
million for the second quarter of 2014 and $1.9 million
year-to-date. In the first half of 2014, the Company shipped $4.2
million of OTREXUP product to wholesalers.
- Ended the quarter with $56.0 million in
cash and investments and no debt.
- Announced the first patient dosed in a
double-blind, multiple-dose, phase 3 study designed to evaluate the
efficacy and safety of QuickShot® testosterone (QS T) in adult
males with testosterone deficiency.
- Presented a scientific poster and
abstract at the 16th International Congress of Endocrinology. The
poster and abstract present the final pharmacokinetic and safety
results from 29 randomized patients treated with a once-weekly
injection of testosterone administered with the QuickShot
device.
- Appointed Eamonn P. Hobbs President and
Chief Executive Officer. Mr. Hobbs joined the Antares Board of
Directors in 2009 and has over 30 years of experience in the
pharmaceutical, medical device and combination products
industry.
- Appointed Jennifer Evans Stacey, Esq.
Senior Vice President, General Counsel, Human Resources and
Secretary. Ms. Stacey has a diversified corporate background
including 20 years of experience in the pharmaceutical
industry.
- Announced a publication in The Annals
of the Rheumatic Diseases of study results comparing the relative
bioavailability, safety and tolerability of OTREXUP to oral
methotrexate in adult patients with rheumatoid arthritis.
Eamonn P. Hobbs, President and Chief Executive Officer of the
Company, stated, “Although early, we continue to make steady
progress on the launch of OTREXUP.” Mr. Hobbs continued, “We
believe recent tactical changes to our launch plan, including an
adjustment to the patient co-pay support program, will further our
goal of making the launch a success. On the development side of the
business, we are pleased to report that enrolment and dosing in the
QuickShot testosterone program is ahead of schedule, and we are
very excited about the high interest level that has been generated
to date both from potential patients and sites looking to
participate in the study. Our device business has successfully
produced both the VIBEX and QuickShot platforms, and we remain
excited about the potential for adding new pipeline projects as
well as entering into future collaborations utilizing our
proprietary technologies.”
Second Quarter and First Half Results
Total revenues were $6.3 million and $5.8 million for the three
months ended June 30, 2014 and 2013, respectively, an increase of
8%. For the six months ended June 30, 2014, the Company’s total
revenue was $11.5 million compared to $10.4 million in the first
six months of 2013.
Product sales were $3.4 million in the second quarter of 2014
compared to $4.5 million in the second quarter of 2013. For the six
months ended June 30, 2014, product sales were $5.2 million
compared to $7.0 million in the first six months of the prior year.
Sales of reusable needle-free injector devices and disposable
components primarily to Ferring and Teva in the second quarters of
2014 and 2013 were $1.7 million and $0.7 million, respectively, and
in the first six months of 2014 and 2013 were $2.9 million and $1.8
million, respectively. In the three and six months ended June 30,
2014, the Company recognized net product sales of $1.7 million and
$1.9 million, respectively, from sales of OTREXUP based on patient
prescriptions dispensed. OTREXUP revenue recognized is net of
estimated wholesaler discounts, prompt pay discounts, rebates and
patient discount programs. In the first half of 2014, the Company
shipped $4.2 million of OTREXUP product to wholesalers and deferred
the difference between distributor sales and prescription sales.
Product sales in the second quarter and first half of 2013 included
$3.6 million and $4.1 million, respectively, of initial sales to
Teva of our VIBEX auto injector for Teva’s generic epinephrine auto
injector product, and the first half of 2013 included $0.5 million
of sales of our topical oxybutynin gel 3% product to Actavis in
connection with their marketing of Gelnique 3%. Product sales in
the first half of 2014 and 2013 also included $0.3 million of sales
of pre-commercial pen injector devices to Teva.
Development revenues were $1.8 million in the three-month period
ended June 30, 2014, compared to $0.6 million in the prior year
period. For the six months ended June 30, 2014, the Company’s
development revenue was $3.2 million compared to $1.4 million in
the first six months of 2013. The development revenue in each year
was primarily due to auto injector and pen injector development
work for Teva.
Licensing revenues were $0.9 million and $0.1 million in the
three-month periods ended June 30, 2014 and 2013, respectively. For
the first half of 2014, licensing revenues were $1.9 million
compared to $0.1 million in the first half of 2013. The licensing
revenue in the second quarter and first half of 2014 was primarily
due to revenue recognized in connection with our license and
promotion agreement with LEO Pharma executed in November 2013. The
licensing revenue in the second quarter and first six months of
2013 was primarily due to recognition of revenue deferred in prior
years under agreements with Ferring.
Royalty revenues were $0.3 million in the three-month period
ended June 30, 2014 compared to $0.7 million in the same period of
the prior year. For the six-month periods ended June 30, 2014 and
2013, royalty revenues were $1.3 million and $1.8 million,
respectively. We receive royalties from Teva and Ferring related to
needle-free injector device sales and/or hGH sales, from Actavis on
sales of Gelnique, and from Meda Pharma on sales of Elestrin®.
Total gross profit was $4.2 million and $2.4 million in the
second quarters of 2014 and 2013, respectively, and was $8.2
million for the first half of 2014 compared to $4.9 million for the
first half of 2013. The increases were primarily the result of
increases in development and licensing revenues.
Total operating expenses were approximately $13.3 million and
$7.5 million for the three months ended June 30, 2014 and 2013,
respectively, and were $26.1 million and $13.4 million for the six
months ended June 30, 2014 and 2013, respectively. The increases
were primarily due to increased sales and marketing costs in
connection with the launch of OTREXUP along with an increase in
legal fees in connection with litigation.
Net loss per share was $0.07 and $0.04 for the second quarters
of 2014 and 2013, respectively, and was $0.14 and $0.07 for the six
month periods ended June 30, 2014 and 2013, respectively.
At June 30, 2014, Antares had approximately $56.0 million in
cash and investments, compared to approximately $69.1 million at
December 31, 2013.
Conference Call, Call Replay and Webcast
Eamonn P. Hobbs, 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 second quarter 2014 results via webcast
and conference call on Thursday, August 7, 2014, at 8:30 a.m.
Eastern Time (ET). A webcast of the call will be available from the
investors section of the Company's web site at
www.antarespharma.com. Alternatively, callers may participate in
the conference call by dialing 1-888-437-9445 (U.S.), or
1-719-325-2362 (International). Participants should reference the
Antares Pharma conference ID 9689728. Webcast and telephone replays
of the conference call will be available approximately two hours
after the completion of the call through 11:30 a.m. ET on August
22, 2014. To access the replay, callers should dial 1-888-203-1112
(U.S.) or 1-719-457-0820 (International) and enter passcode
9689728.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products. The Company markets OTREXUP™
(methotrexate) injection for the treatment of adults with severe
active rheumatoid arthritis and children with active polyarticular
juvenile idiopathic arthritis. LEO Pharma markets OTREXUP™ to
dermatologists for adults with severe recalcitrant psoriasis.
Antares Pharma is also developing VIBEX® QS T for testosterone
replacement therapy. The Company's technology platforms include
VIBEX® disposable Medi-Jet, disposable multi-use pen injectors and
reusable needle-free injectors marketed as Tjet® and Zomajet® by
Teva Pharmaceutical Industries, Ltd (Teva) and Ferring
Pharmaceuticals (Ferring), respectively. Antares Pharma has a
multi-product deal with Teva that includes Tev-Tropin® [somatropin
(rDNA origin) for injection] human growth hormone (hGH), VIBEX®
epinephrine and several other products. In the U.S. Antares has
received FDA approval for Gelnique 3%™ (oxybutynin) gel, a
treatment for overactive bladder that is marketed by Actavis.
Elestrin® (estradiol gel) is FDA approved for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause,
and is marketed in the U.S. by Meda Pharma. 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 Medi-Jet
and pen injector systems. The Company’s corporate office and
Product Development and Commercial Groups are located in Ewing, New
Jersey.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements made with
respect to the timing of the Company’s phase 3 study of
QuickShot® testosterone in testosterone-deficient
males; the impact of changes to the launch plan on future sales of
Otrexup™; the potential for adding new pipeline products to the
Company’s device business; the potential for entering into future
collaborations utilizing the Company’s proprietary technologies;
and other statements regarding matters that are not historical
facts, and involve predictions. These statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results, performance, achievements or prospects to be
materially different from any future results, performance,
achievements or prospects expressed in or implied by such
forward-looking statements. In some cases you can identify
forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'',
''potential'', ''seem'', ''seek'', ''future'', ''continue'', or
''appear'' or the negative of these terms or similar expressions,
although not all forward-looking statements contain these
identifying words. 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.
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, 2013, 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,
2014 2013 (Unaudited) Assets Cash and
investments $ 56,023 $ 69,090 Accounts receivable 3,065 1,034
Inventory 8,335 6,461 Equipment, molds, furniture and fixtures, net
8,613 6,952 Patent rights 2,630 1,345 Goodwill 1,095 1,095 Other
assets 2,965 2,955 Total Assets $ 82,726 $ 88,932
Liabilities and Stockholders’ Equity Accounts payable
and accrued expenses $ 14,881 $ 11,832 Deferred revenue 12,409
6,386 Stockholder’s equity 55,436 70,714 Total
Liabilities and Stockholders’ Equity $ 82,726 $ 88,932
ANTARES PHARMA, INC.
CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS
(amounts in thousands except share
amounts)
(Unaudited)
For the Three Months Ended For the
Six Months Ended June 30, June 30, 2014
2013 2014 2013 Product sales $
3,360 $ 4,513 $ 5,165 $ 7,005 Development revenue 1,789 588 3,210
1,382 Licensing revenue 928 69 1,856 138 Royalties 250
668 1,298 1,841
Total Revenue 6,327 5,838 11,529 10,366 Cost of revenue
2,130 3,481 3,307
5,508 Gross Profit 4,197 2,357 8,222 4,858 Research
and development 3,943 4,396 8,476 7,468 Sales and marketing 5,014
1,158 10,524 2,040 General and administrative 4,331
1,934 7,121 3,884 Total
Operating Expenses 13,288 7,488
26,121 13,392 Operating loss (9,091 )
(5,131 ) (17,899 ) (8,534 ) Other income and expenses
(7 ) 28 7 22 Net
loss $ (9,098 ) $ (5,103 ) $ (17,892 ) $ (8,512 ) Basic and
diluted net loss per common share $ (0.07 ) $ (0.04 ) $ (0.14 ) $
(0.07 ) Basic and diluted weighted average common shares
outstanding
130,052
126,463
129,855
126,286
Antares Pharma, Inc.Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
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