Record Second Quarter Revenues Driven by
Increased OTREXUP and Device Sales
Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating and
financial results for the second quarter ended June 30, 2015. The
Company reported revenue of $14.4 million and a net loss per share
of $0.01 for the second quarter and revenue of $22.8 million and a
net loss of $0.06 per share for the first half of 2015. Antares
ended the second quarter with $58.1 million in cash, cash
equivalents and investments and no debt.
“Record second quarter results were driven by double-digit
growth in OTREXUP prescriptions, coupled with the first shipments
of epinephrine auto injector devices to our partner Teva in
anticipation of a potential U.S. FDA approval this year,” said
Eamonn P. Hobbs, President and Chief Executive Officer of the
Company. “We are pleased with the renewed growth of OTREXUP
prescriptions and believe that ongoing enhancements to the OTREXUP
sales and marketing plans will continue to produce revenue growth.
In addition, with respect to Teva and potential FDA approval for
the epinephrine auto injector device, our plan is to continue to
manufacture and deliver pre-launch quantities of product throughout
the second half of this year as Teva prepares for their potential
launch.”
Second Quarter 2015 and Recent Highlights
- Reported record quarterly revenues of
$14.4 million including $3.3 million in OTREXUP™ sales and $1.8
million in revenues generated from epinephrine auto injector
devices sold and shipped to Teva during the second quarter.
- Announced the enrollment of the first
patients in the QuickShot testosterone supplemental safety study.
We believe a minimum of 70 patients will be needed to complete
collection of 26 weeks of safety data.
- Increased the number of prescriptions
to 8,123 and unique prescribers of OTREXUP™ (methotrexate)
injection to approximately 1,673 physicians at the end of the
second quarter as compared to 6,722 prescriptions and approximately
1,546 physicians at the end of the first quarter, according to
Symphony Health Solutions.
- Completed an underwritten public
offering of 23.0 million shares of the Company’s common stock at a
purchase price of $2.00 per share, resulting in net proceeds to the
Company of $42.8 million.
- Appointed Peter J Graham Esq. to the
position of Senior Vice President, General Counsel, Human
Resources, Chief Compliance Officer and Corporate Secretary.
- Announced the settlement of all
litigation between Antares and Medac Pharma, Inc. and its parent
medac GmbH. The settlement agreement provides for a royalty-free
cross-license under the patents-in-suit for the U.S.
- Regained U.S. marketing rights to
OTREXUP™ (methotrexate) injection for subcutaneous use for the
psoriasis indication through the termination of an exclusive
promotion and marketing agreement with LEO Pharma A/S.
Second Quarter and First Half Financial Results
Total revenue was $14.4 million for the three months ended June
30, 2015, compared to $6.3 million for the comparable period in
2014, representing an increase of 128%. For the six months ended
June 30, 2015, total revenue was $22.8 million, a 97% increase as
compared to the total revenue of $11.5 million for the six months
ended June 30, 2014. See Table 1 attached for further details on
revenues.
Product sales represent sales of our proprietary products and
devices or device components to our partners. Product sales were
$5.8 million for the three months ended June 30, 2015, compared to
$3.4 million for the comparable period in 2014, and totalled $10.5
million for the six months ended June 30, 2015 as compared to $5.2
million in the comparable period of 2014. The increase in product
sales for the three and six months ended June 30, 2015 over the
comparable periods of 2014 was primarily driven by the growth of
Otrexup and the sale of pre-launch quantities of epinephrine auto
injectors to Teva in anticipation of an approval later this
year.
Development revenue represents amounts earned under arrangements
with partners in which we develop new products on their behalf.
Frequently, we receive payments from our partners that are
initially deferred and recognized as revenue over a development
period or upon completion of defined deliverables. Development
revenue was $3.0 million and $5.4 million for the three and six
months ended June 30, 2015, respectively, compared to $1.8 million
and $3.2 million for the comparable periods in 2014.
Licensing revenues represent the amounts recognized from
up-front or milestone payments received from partners that are
initially deferred and recognized over the life of our agreements.
Licensing revenue was $5.2 million for the three months ended June
30, 2015, compared to $0.9 million for the comparable period in
2014. Licensing revenue for the first half of 2015 totalled $6.1
million compared to $1.9 million for the first half of 2014. The
increase in licensing revenue is primarily related to payments
previously received and deferred from LEO Pharma A/S that were
fully recognized upon termination of our agreement in June
2015.
Royalty revenue is recognized primarily from the in-market sales
of products sold by our partners. Royalty revenue was $0.4 million
for the three months ended June 30, 2015, compared to $0.3 million
for the comparable period in 2014. Royalty revenue for the first
half of 2015 totalled $0.8 million compared to $1.3 million for the
first half of 2014. The decrease in royalties in the first half of
2015 is primarily due to the decision made by Teva in April 2014 to
recall the drug product formerly known as Tev-Tropin (not the
device supplied by the Company).
Total gross profit increased in the second quarter of 2015 to
$9.7 million compared to $4.2 million in the comparable period in
2014. Total gross profit for the first half of 2015 totalled $14.4
million as compared to $8.2 million in the first half of 2014,
representing a period over period increase of 75%. The increase was
primarily driven by the payments previously received and deferred
from LEO Pharma A/S that were fully recognized as revenue upon
termination of our agreement in June 2015.
Total operating expenses were $11.2 million in the second
quarter of 2015 compared to $13.3 million in the comparable period
in 2014. Total operating expenses for the six months ended June 30,
2015 were approximately $22.6 million as compared to $26.1 million
for the comparable period in 2014. The decrease in operating
expenses was driven by higher costs incurred in 2014 associated
with the launch of OTREXUP™ and legal costs that were paid in 2014
for litigation that was settled in 2015.
Net loss was approximately $1.5 million and $8.3 million for the
second quarter and first half of 2015, respectively, as compared to
$9.1 million and $17.9 million for the comparable periods in
2014.
At June 30, 2015, cash, cash equivalents and investments
totalled approximately $58.1 million compared to approximately
$40.0 million at December 31, 2014.
Conference Call, Call Replay and Webcast
Antares Executives will provide a Company update and review
second quarter 2015 operating results via webcast and conference
call on Monday, August 10, 2015, at 8:30 a.m. ET (Eastern Time).
The webcast of the conference call, which will include a slide
presentation, can be accessed through the link located on the
“ATRS Investor Information” section of the Company’s website
(www.antarespharma.com) under the “Webcast” tab. Alternatively,
callers may participate in the audio portion of the conference call
by dialing 1-888-461-2024 (US), or 1-719-325-2308 (International).
Callers should reference the Antares Pharma conference call or
conference identification code 2596882. Callers can access the
slide presentation on the “ATRS Investor Information” section of
the Company’s website under the “Presentations” tab. Webcast and
telephone replays of the conference call will be available from
11:30 a.m. ET on Monday, August 10, 2015 through 11:30 a.m. ET on
Tuesday, August 25, 2015. To access the replay, callers should dial
1-888-203-1112 (US) or 1-719-457-0820 (International) and enter
passcode 2596882.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products. The Company’s product, OTREXUP™
(methotrexate) injection for subcutaneous use, is approved in the
U.S. for the treatment of adults with severe active rheumatoid
arthritis, children with active polyarticular juvenile idiopathic
arthritis and adults with severe recalcitrant psoriasis. Antares
Pharma is also developing QuickShot® Testosterone for testosterone
replacement therapy, and VIBEX® Sumatriptan for the acute treatment
of migraines. The Company's technology platforms include VIBEX®
disposable auto injectors, disposable multi-use pen injectors and
reusable needle-free injectors. Antares Pharma has a multi-product
deal with Teva Pharmaceutical Industries, Ltd. that includes VIBEX®
epinephrine, exenatide multi-dose pen, and another undisclosed
multi-dose pen. Our reusable needle-free injector for use with
human growth hormone (hGH) is sold worldwide by Ferring B.V.
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 growth of the Company from a company solely
dependent on licensing and development revenues to a specialty
pharmaceutical company commercializing its own products; the growth
of sales of OTREXUP™; the approval by the U.S. Food and Drug
Administration (FDA) of VIBEX® Epinephrine Pen, the
timing thereof, the therapeutic equivalence rating therefor and
future sales by Teva; the timing and results of the supplemental
phase 3 safety study for QuickShot® Testosterone (QS
T); acceptance of the data from the supplemental phase 3 safety
study by the U.S. Food and Drug Administration (FDA); FDA actions
with respect to QS T including modified or additional clinical
trials; the Company’s ability to successfully complete a New Drug
Application for QS T to the FDA and approval of the same; FDA
action with respect to the ANDA filed for the exenatide pen; the
Company’s ability to adequately and timely respond to the complete
response letter with respect to its ANDA for
VIBEX® Sumatriptan and FDA action with respect to
the same; future revenue from the U.S. marketing rights to
OTREXUP™ (methotrexate) injection for subcutaneous
use for the psoriasis; the timing and results of research projects,
clinical trials, and product candidates in development; the
Company’s ability to obtain financial and other resources for its
research, development, clinical, and commercial activities 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, 2014, 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.
Table 1 - CONSOLIDATED REVENUE
DETAILS
(amounts in thousands, except for
percentages)
(unaudited)
Three Months Ended
June 30,
Increase
Six Months Ended
June 30,
Increase
2015 2014 (Decrease) 2015
2014 (Decrease) OTREXUP™ $ 3,346 $ 1,671 100 % $
6,350 $ 1,884 237 % Needle-free injector devices and components 725
1,689 (57 ) % 2,146 2,945 (27 ) % Auto injector and pen injector
devices 1,769 - N/A 1,967 336
485 % Total product sales 5,840 3,360 74 % 10,463 5,165 103 %
Development revenue 3,027 1,789 69 % 5,416 3,210 69 % Licensing
revenue 5,186 928 459 % 6,069 1,856 227 % Royalties 367
250 47 % 820 1,298 (37 ) % Total revenue $
14,420 $ 6,327 128 % $ 22,768 $ 11,529 97 %
ANTARES PHARMA, INC.
Table 2 - CONSOLIDATED CONDENSED
STATEMENTS OF OPERATIONS
(amounts in thousands except per share
amounts)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2015 2014 2015 2014
Product sales $ 5,840 $ 3,360 $ 10,463 $ 5,165 Development revenue
3,027 1,789 5,416 3,210 Licensing revenue 5,186 928 6,069 1,856
Royalties 367 250 820
1,298 Total revenue 14,420 6,327 22,768 11,529
Cost of revenue 4,708 2,130
8,382 3,307 Gross profit 9,712 4,197 14,386
8,222 Research and development 4,569 3,943 8,947 8,477
Selling, general and administrative 6,605
9,345 13,642 17,645 Total
Operating Expenses 11,174 13,288
22,589 26,122 Operating loss (1,462 )
(9,091 ) (8,203 ) (17,899 ) Other income (expense) (45 )
(7 ) (91 ) 7 Net loss $ (1,507 ) $
(9,098 ) $ (8,294 ) $ (17,892 ) Basic and diluted net loss
per common share $ (0.01 ) $ (0.07 ) $ (0.06 ) $ (0.14 )
Basic and diluted weighted average common
shares outstanding
144,650
130,052
138,233
129,855
ANTARES PHARMA, INC.
Table 3 – CONSOLIDATED CONDENSED
BALANCE SHEETS
(amounts in thousands)
(unaudited)
June 30, 2015
December 31, 2014
Assets Cash and investments $ 58,143 $ 40,031 Accounts
receivable 6,450 3,510 Inventories 5,466 5,860 Equipment, molds,
furniture and fixtures, net 13,559 10,829 Patent rights, net 2,701
2,885 Goodwill 1,095 1,095 Other assets 4,119 4,563
Total Assets $ 91,533 $ 68,773
Liabilities and
Stockholders’ Equity Accounts payable and accrued expenses $
10,420 $ 15,707 Deferred revenue 3,769 11,870 Stockholders’ equity
77,344 41,196 Total Liabilities and Stockholders’
Equity $ 91,533 $ 68,773
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version on businesswire.com: http://www.businesswire.com/news/home/20150810005305/en/
Antares Pharma, Inc.Jack Howarth, 609-359-3016Vice President,
Corporate Affairsjhowarth@antarespharma.com
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