Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating and
financial results for the first quarter ended March 31, 2017.
The Company reported revenue of $12.0 million and a net loss per
share of $0.03 for the period ended March 31, 2017.
“We are pleased with the continued growth in
OTREXUP and Sumatriptan Injection, both products developed and
supplied by Antares for commercial sale. With the potential
for a late 2017 approval of QuickShot testosterone, we will
leverage and look to expand our existing commercial organization
and infrastructure to support the launch of QST into a large market
opportunity which we believe may benefit from a new treatment
option,” said Robert F. Apple, President and Chief Executive
Officer of the Company. “The Company’s first quarter results
reflect a continued focus on growing product revenue, producing
prelaunch quantities of commercial devices and controlling
operating expenses with appropriate reinvestment in our future
while we await potential FDA approval of four partnered drug device
combination products as well as our own QST product.”
First Quarter 2017 and Recent
Highlights
- Reported first quarter 2017 revenue of $12.0 million, loss per
share of $0.03 and cash and cash equivalents of $23.7 million at
March 31, 2017.
- Announced that our New Drug Application had been accepted as
filed by the U.S. Food and Drug Administration (FDA) for QuickShot®
Testosterone (QST), a drug-device combination product for the
delivery of testosterone enanthate using a subcutaneous auto
injector. QST is intended to treat adult men with low
testosterone associated with a diagnosed condition known as
hypogonadism. The application is currently under active
review by the FDA with an October 20, 2017 PDUFA date.
- Announced that data from the 52 week phase 3 study of the
pharmacokinetics and safety of subcutaneous testosterone enanthate
delivered through the QuickShot® auto injector was presented at a
moderated poster session at the Endocrine Society Annual Meeting
(ENDO 2017).
- AMAG Pharmaceuticals, Inc. announced the submission of a
supplemental new drug application (sNDA) to the U.S. Food and Drug
Administration (FDA) for the Makena® subcutaneous auto injector, a
drug-device combination product utilizing Antares’ QuickShot® auto
injector. AMAG anticipates a six month FDA review timeline
for possible approval and launch in the fourth quarter of
2017.
First Quarter Financial
Results
Revenue was $12.0 million for the three months
ended March 31, 2017, compared to $12.3 million for the comparable
period in 2016. 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 $10.0 million for the three months ended March
31, 2017, compared to $10.8 million for the comparable period in
2016. The decrease in product sales was primarily driven by a
reduction in sales of pre-launch quantities of auto injector
devices for use with Teva’s generic epinephrine product, partially
offset by increased sales of Sumatriptan Injection USP and
OTREXUP®. For the three months ended March 31, 2017, we recognized
a one-time increase of $1.3 million in OTREXUP® product revenue for
amounts that were previously deferred in accordance with generally
accepted accounting principles. In the first quarter of 2017, we
began recognizing revenue, net of estimated returns, upon delivery
to distributors.
Development revenue was $1.6 million for the three
months ended March 31, 2017, compared to $1.1 million for the
comparable period in 2016. The increase in development
revenue was primarily a result of increases in development
activities with Teva for the exenatide and teriparatide pen
injector products and with AMAG for the Makena® auto injector
product, offset by a reduction in revenue for development
activities with Teva in connection with the epinephrine auto
injector. Development revenues represent 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.
Royalty revenue is recognized primarily from the
in-market sales of products sold by our partners. Royalty
revenue was $0.3 million for the three months ended March 31, 2017
and 2016, respectively.
Gross profit increased in the first quarter of 2017
to $5.8 million compared to $5.5 million in the same period in
2016. The increase was primarily attributable to the recognition of
previously deferred revenue for OTREXUP® sales, and sales of
Sumatriptan Injection USP, offset by a reduction in epinephrine
auto injector device sales.
Operating expenses were approximately $10.6 million
for the first quarter of 2017 compared to $13.3 million in the
comparable period of 2016. The decrease in operating expenses
in the first quarter of 2017 was primarily due to a reduction in
external clinical and development costs related to QST and a
decrease in personnel costs in connection with the departure of the
former CEO in 2016.
Net loss was $4.7 million for the first quarter of
2017, compared to $7.7 million in the comparable period in
2016. Net loss per share was $0.03 for the quarter ended
March 31, 2017 and $0.05 for the comparable period in 2016.
At March 31, 2017, cash and cash equivalents
totaled $23.7 million compared to $27.7 million at December 31,
2016.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review first quarter 2017 financial results via webcast and
conference call on Tuesday, May 9, 2017, 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 1-888-417-8525 (US), or
1-719-457-2702 (International). Callers should reference the
Antares Pharma conference call or conference identification code
2882372. 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 Tuesday,
May 9, 2017, through 11:30 a.m. ET on Thursday, June 8, 2017. To
access the replay, callers should dial 1-888-203-1112 (US) or
1-719-457-0820 (International) and enter passcode
2882372.
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. The
Company’s product Sumatriptan Injection USP, is approved in the
U.S. for the acute treatment of migraine and cluster headache and
is distributed by Teva Pharmaceutical Industries, Ltd. (Teva).
Antares Pharma is also developing QuickShot® Testosterone for
testosterone replacement therapy and has filed a New Drug
Application with the Food and Drug Administration. The Company's
technology platforms include VIBEX® disposable auto injectors,
disposable multi-use pen injectors and reusable needle-free
injectors. Antares Pharma has license, development and supply
agreements with Teva that include VIBEX® epinephrine, exenatide
multi-dose pen, and teriparatide multi-dose pen. Our reusable
needle-free injector for use with human growth hormone (hGH) is
sold worldwide by Ferring B.V. The Company is also working
with AMAG Pharmaceuticals on a subcutaneous method for
administering Makena, a progesterone product indicated for use in
lowering the risk of pre-term birth. For more information,
visit www.antarespharma.com.
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.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: U.S. Food and Drug Administration
(“FDA”) approval of the QST NDA and future market acceptance and
revenue for QST; FDA approval of the sNDA submitted by AMAG
Pharmaceuticals for an auto injector for Makena and future market
acceptance and revenue of the same; the outcome of the pending
patent litigation between Teva Pharmaceutical Industries, Ltd.
(Teva) and Eli Lilly and Company regarding the Teriparatide
multi-dose pen; FDA action with respect to Teva’s Abbreviated New
Drug Application (“ANDA”) for the Teriparatide multi-dose pen and
the timing and approval, if any, by the FDA of the same; Teva’s
ability to adequately respond to the Complete Response Letter
received from the FDA for the VIBEX® epinephrine pen ANDA and
approval by the FDA of the same, the timing and therapeutic
equivalence rating thereof, and any future purchase orders and
revenue pre or post FDA approval; Teva’s ability to successfully
commercialize VIBEX® Sumatriptan Injection USP and the amount of
revenue from the same; FDA action with respect to Teva’s ANDA filed
for the Exenatide pen and future revenue from the same; continued
growth of prescriptions and sales of OTREXUP®; the timing and
results of research projects, clinical trials, and product
candidates in development; actions by the FDA or other regulatory
agencies with the respect to the Company’s products or product
candidates of its partners; continued growth in product,
development, licensing and royalty revenue; 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.
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, 2016, 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 March 31, |
|
|
Increase |
|
|
|
2017 |
|
|
2016 |
|
|
(Decrease) |
|
OTREXUP® |
|
$ |
4,564 |
|
|
$ |
3,310 |
|
|
|
38 |
% |
|
Auto injector and pen
injector devices |
|
|
4,108 |
|
|
|
5,979 |
|
|
|
(31 |
%) |
|
Needle-free injector
devices and components |
|
|
1,364 |
|
|
|
1,552 |
|
|
|
(12 |
%) |
|
Total product
sales |
|
|
10,036 |
|
|
|
10,841 |
|
|
|
(7 |
%) |
|
Development
revenue |
|
|
1,622 |
|
|
|
1,098 |
|
|
|
48 |
% |
|
Licensing revenue |
|
|
19 |
|
|
|
51 |
|
|
|
(63 |
%) |
|
Royalties |
|
|
330 |
|
|
|
329 |
|
|
|
0 |
% |
|
Total revenue |
|
$ |
12,007 |
|
|
$ |
12,319 |
|
|
|
(3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA, INC. |
Table 2 - CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS |
(amounts in thousands except per share
amounts) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
10,036 |
|
|
$ |
10,841 |
|
Development revenue |
|
|
1,622 |
|
|
|
1,098 |
|
Licensing
revenue |
|
|
19 |
|
|
|
51 |
|
Royalties |
|
|
330 |
|
|
|
329 |
|
Total
revenue |
|
|
12,007 |
|
|
|
12,319 |
|
Cost of revenue |
|
|
6,219 |
|
|
|
6,776 |
|
Gross
profit |
|
|
5,788 |
|
|
|
5,543 |
|
Research and
development |
|
|
3,086 |
|
|
|
5,648 |
|
Selling, general and
administrative |
|
|
7,468 |
|
|
|
7,603 |
|
Total
operating expenses |
|
|
10,554 |
|
|
|
13,251 |
|
Operating loss |
|
|
(4,766 |
) |
|
|
(7,708 |
) |
Other income |
|
|
30 |
|
|
|
52 |
|
Net loss |
|
$ |
(4,736 |
) |
|
$ |
(7,656 |
) |
Basic and diluted net
loss per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.05 |
) |
Basic and diluted
weighted average common shares outstanding |
|
|
155,215 |
|
|
|
154,858 |
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA, INC. |
|
Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS |
(amounts in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
|
2017 |
|
|
2016 |
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
23,677 |
|
|
$ |
27,715 |
|
|
Accounts
receivable |
|
|
7,885 |
|
|
|
9,073 |
|
|
Inventories |
|
|
6,852 |
|
|
|
5,327 |
|
|
Equipment, molds,
furniture and fixtures, net |
|
|
17,608 |
|
|
|
17,867 |
|
|
Patent rights, net |
|
|
1,925 |
|
|
|
2,045 |
|
|
Goodwill |
|
|
1,095 |
|
|
|
1,095 |
|
|
Other assets |
|
|
3,286 |
|
|
|
3,203 |
|
|
Total
Assets |
|
$ |
62,328 |
|
|
$ |
66,325 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
15,795 |
|
|
$ |
13,758 |
|
|
Deferred revenue |
|
|
5,129 |
|
|
|
7,349 |
|
|
Stockholders’
equity |
|
|
41,404 |
|
|
|
45,218 |
|
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
62,328 |
|
|
$ |
66,325 |
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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