Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating and
financial results for the third quarter ended September 30,
2017. The Company reported record revenue of $15.1 million
and a net loss per share of $0.03 for the three months ended
September 30, 2017. For the nine months ended September
30, 2017, the Company reported revenue of $40.5 million and a net
loss per share of $0.08.
“We are very pleased with the progress of our quarterly
financial results as Antares today reported record revenue driven
by a significant increase in product sales, specifically OTREXUP
and Sumatriptan Injection,” said Robert F. Apple, President and
Chief Executive Officer of the Company. He continued, “In the
development area, we are disappointed with the outcome of the
review of the XYOSTED new drug application and the delay of the
potential product launch. We continue to believe that we have
a viable product in XYOSTED and will be requesting a meeting with
the U.S. Food and Drug Administration to understand and resolve the
deficiencies noted in the Complete Response Letter, and agree upon
a path forward for a potential approval.”
Third Quarter 2017 and Recent Highlights
- Reported third quarter 2017 revenue of $15.1 million, loss per
share of $0.03 and cash, cash equivalents and short-term
investments of $37.4 million at September 30, 2017.
- OTREXUP® revenue grew 18% sequentially versus the second
quarter of 2017 and 18% versus the third quarter of
2016.
- Sumatriptan Injection USP total prescriptions increased to a
27% share of the migraine auto injector market in the third quarter
of 2017, up from 26% in the second quarter of 2017 according to
data from Symphony Health Solutions.
- Announced the sale of the ZOMAJET™ needle-free delivery system
to Ferring Pharmaceuticals for up to $14.5 million. The
transaction is subject to certain customary closing conditions and
is expected to be completed by the end of 2018.
- Received a Complete Response Letter from the U.S. Food and Drug
Administration (FDA) regarding the New Drug Application for
XYOSTED™ (testosterone enanthate) injection. The FDA cited
two deficiencies related to clinical data. The next step will
be to request a meeting with the FDA to further evaluate the
deficiencies and agree on a path forward for a potential approval
of XYOSTED™.
Third Quarter and Nine Month Financial
Results
Total revenue represents revenue generated from sales of
OTREXUP, Sumatriptan Injection USP, product sales of auto injectors
and components, development and licensing revenue and
royalties. Total Revenue was $15.1 million for the three
months ended September 30, 2017, compared to $13.5 million for the
comparable period in 2016. For the nine months ended
September 30, 2017, total revenue was $40.5 million, compared to
total revenue of $38.0 million for the nine months ended September
30, 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 $13.3 million for the three months ended September 30, 2017,
compared to $11.1 million for the comparable period in 2016, and
were $30.7 million for the nine months ended September 30, 2017
compared to $30.6 million in the same period of 2016. The
increase in product sales for the three month period was primarily
driven by an increase in OTREXUP® revenue, shipments of Sumatriptan
Injection USP and the related profit earned under the profit
sharing arrangement with Teva.
Development revenue was $1.5 million for the three months ended
September 30, 2017, compared to $2.1 million for the comparable
period in 2016, and was $7.9 million for the nine months ended
September 30, 2017 compared to $6.5 million in the same period of
2016. The decrease in development revenue for the third
quarter of 2017 compared to 2016 was primarily a result of lower
development revenue related to the Makena® auto injector program
with AMAG and the pen injector programs with Teva. The
increase in development revenue for the nine month period was
primarily the result of increased development activities with AMAG
for the Makena® auto injector product offset by lower development
revenue from the pen injector and auto injector programs with
Teva.
Gross profit increased in the three months ended September 30,
2017 to $6.5 million compared to $5.4 million in the same period in
2016. Gross profit for the nine months ended September 30, 2017 was
$20.1 million as compared to $15.9 million in the comparable period
of 2016. The increase in gross profit for the three month
period was primarily attributed to sales of OTREXUP® and
Sumatriptan Injection USP. The increase in gross profit for
the nine month period was primarily attributable to the
recognition of $1.0 million in licensing fees previously deferred
for which there was no associated cost, the recognition of
previously deferred OTREXUP® revenue and sales of Sumatriptan
Injection USP.
Operating expenses were $11.5 million for the three months ended
September 30, 2017 compared to $11.6 million in the comparable
period of 2016. Operating expenses for the nine months ended
September 30, 2017 were $32.5 million as compared to $35.8 million
for the same period in 2016. The decrease in operating
expenses for the three and nine month periods of 2017 was primarily
due to a reduction in external clinical and development costs
related to XYOSTED™ offset by an increase in sales and marketing
expenses associated with the preparation for a potential launch
of XYOSTED™.
Net loss was $5.5 million for the three months ended September
30, 2017, compared to $6.1 million in the comparable period in
2016, and $13.0 million for the nine months ended September 30,
2017 compared to $19.8 million in the same period of 2016.
Net loss per share was $0.03 and $0.08 for the three and nine
month periods ended September 30, 2017, respectively, and $0.04 and
$0.13 for the comparable periods in 2016, respectively.
At September 30, 2017, cash, cash equivalents and short-term
investments were $37.4 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
third quarter 2017 financial results via webcast and conference
call on Tuesday, November 7, 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 1-866-564-2842 (US), or 1-323-794-2094
(International). Callers should reference the Antares Pharma
conference call or conference identification code 8463517. We
encourage interested participants to dial into the conference call
at least 10 minutes prior to the scheduled start time. 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, November 7, 2017, through
11:30 a.m. ET on Thursday, December 7, 2017. To access the replay,
callers should dial 1-888-203-1112 (US) or 1-719-457-0820
(International) and enter passcode 8463517.
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 an investigational new drug,
XYOSTED™, for testosterone replacement therapy. The Company filed a
New Drug Application, received a Complete Response Letter, and is
evaluating a path forward for a potential approval of XYOSTED™. The
Company's technology platforms include VIBEX® disposable auto
injectors and disposable multi-use pen injectors. Antares Pharma
has license, development and supply agreements with Teva that
include VIBEX® epinephrine, exenatide multi-dose pen, and
teriparatide multi-dose pen. 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: the Company’s ability to adequately and
timely respond to the deficiencies in the XYOSTED™ CRL issued by
the FDA, whether any such response will be accepted by the
FDA, the Company’s ability and timing to resubmit
the NDA for XYOSTED™, and FDA acceptance of the resubmitted NDA and
any approval of the Company’s NDA for XYOSTED™,
successful completion of the transaction with Ferring
International Center, S.A. and satisfaction of the various
conditions in the Ferring asset purchase agreement and payment of
the full purchase price, 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 the 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
expectations about timing and approval of the VIBEX® epinephrine
pen ANDA by the FDA and potential product launch of the same, the
therapeutic equivalence rating thereof, and any future revenue from
the same; 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.
Contacts:Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
TABLES FOLLOW
ANTARES PHARMA,
INC.Table 1 - CONSOLIDATED REVENUE
DETAILS(amounts in thousands, except for
percentages)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September
30, |
|
|
Increase |
|
|
Nine Months Ended September
30, |
|
|
Increase |
|
|
|
2017 |
|
|
2016 |
|
|
(Decrease) |
|
|
2017 |
|
|
2016 |
|
|
(Decrease) |
|
OTREXUP® |
|
$ |
4,624 |
|
|
$ |
3,904 |
|
|
|
18 |
% |
|
|
$ |
13,111 |
|
|
$ |
11,024 |
|
|
|
19 |
% |
|
Auto injector and pen
injector devices |
|
|
7,946 |
|
|
|
5,944 |
|
|
|
34 |
% |
|
|
|
14,490 |
|
|
|
15,836 |
|
|
|
(8 |
%) |
|
Needle-free injector
devices and components |
|
|
758 |
|
|
|
1,202 |
|
|
|
(37 |
%) |
|
|
|
3,108 |
|
|
|
3,720 |
|
|
|
(16 |
%) |
|
Total product
sales |
|
|
13,328 |
|
|
|
11,050 |
|
|
|
21 |
% |
|
|
|
30,709 |
|
|
|
30,581 |
|
|
|
<1% |
|
Development
revenue |
|
|
1,485 |
|
|
|
2,101 |
|
|
|
(29 |
%) |
|
|
|
7,895 |
|
|
|
6,467 |
|
|
|
22 |
% |
|
Licensing revenue |
|
|
19 |
|
|
|
39 |
|
|
|
(51 |
%) |
|
|
|
1,057 |
|
|
|
128 |
|
|
|
>100% |
|
Royalties |
|
|
220 |
|
|
|
289 |
|
|
|
(24 |
%) |
|
|
|
815 |
|
|
|
850 |
|
|
|
(4 |
%) |
|
Total revenue |
|
$ |
15,052 |
|
|
$ |
13,479 |
|
|
|
12 |
% |
|
|
$ |
40,476 |
|
|
$ |
38,026 |
|
|
|
6 |
% |
|
|
ANTARES PHARMA,
INC.Table 2 - CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS(amounts in thousands except per share
amounts)(unaudited)
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
13,328 |
|
|
$ |
11,050 |
|
|
$ |
30,709 |
|
|
$ |
30,581 |
|
Development revenue |
|
|
1,485 |
|
|
|
2,101 |
|
|
|
7,895 |
|
|
|
6,467 |
|
Licensing
revenue |
|
|
19 |
|
|
|
39 |
|
|
|
1,057 |
|
|
|
128 |
|
Royalties |
|
|
220 |
|
|
|
289 |
|
|
|
815 |
|
|
|
850 |
|
Total
revenue |
|
|
15,052 |
|
|
|
13,479 |
|
|
|
40,476 |
|
|
|
38,026 |
|
Cost of Revenue |
|
|
8,523 |
|
|
|
8,034 |
|
|
|
20,359 |
|
|
|
22,128 |
|
Gross
profit |
|
|
6,529 |
|
|
|
5,445 |
|
|
|
20,117 |
|
|
|
15,898 |
|
Research and
development |
|
|
3,289 |
|
|
|
5,958 |
|
|
|
9,535 |
|
|
|
15,555 |
|
Selling, general and
administrative |
|
|
8,186 |
|
|
|
5,623 |
|
|
|
23,013 |
|
|
|
20,241 |
|
Total
operating expenses |
|
|
11,475 |
|
|
|
11,581 |
|
|
|
32,548 |
|
|
|
35,795 |
|
Operating loss |
|
|
(4,946 |
) |
|
|
(6,136 |
) |
|
|
(12,431 |
) |
|
|
(19,897 |
) |
Other (expense)
income |
|
|
(507 |
) |
|
|
15 |
|
|
|
(597 |
) |
|
|
58 |
|
Net loss |
|
$ |
(5,453 |
) |
|
$ |
(6,121 |
) |
|
$ |
(13,028 |
) |
|
$ |
(19,839 |
) |
Basic and diluted net
loss per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.13 |
) |
Basic and diluted
weighted average common shares outstanding |
|
|
156,401 |
|
|
|
155,061 |
|
|
|
155,852 |
|
|
|
154,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 - CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
|
$ |
37,410 |
|
|
$ |
27,715 |
|
Accounts
receivable |
|
|
10,147 |
|
|
|
9,073 |
|
Inventories |
|
|
7,942 |
|
|
|
5,327 |
|
Equipment, molds,
furniture and fixtures, net |
|
|
17,297 |
|
|
|
17,867 |
|
Patent rights, net |
|
|
1,631 |
|
|
|
2,045 |
|
Goodwill |
|
|
1,095 |
|
|
|
1,095 |
|
Other assets |
|
|
2,948 |
|
|
|
3,203 |
|
Total
Assets |
|
$ |
78,470 |
|
|
$ |
66,325 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
14,639 |
|
|
$ |
13,758 |
|
Deferred revenue |
|
|
3,043 |
|
|
|
7,349 |
|
Long-term debt |
|
|
24,791 |
|
|
|
- |
|
Stockholders’
equity |
|
|
35,997 |
|
|
|
45,218 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
78,470 |
|
|
$ |
66,325 |
|
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