2016 Results Driven by Continued Growth
in Product Sales and Significant Progress in Pipeline
Programs
Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating
progress and financial results for the fourth quarter and full year
ended December 31, 2016. The Company reported revenue of
$14.2 million for the fourth quarter of 2016 and $52.2 million for
the full year ended December 31, 2016. Net loss per share was
$0.03 and $0.16 for the fourth quarter and full year 2016,
respectively.
“I am pleased to announce another year of
continued strong financial results for the Company and significant
progress with a number of our pipeline initiatives which include
both internally developed products as well as partnered programs
utilizing our device technology,” said Robert F. Apple, President
and Chief Executive Officer of the Company. “Record
full year 2016 revenue is the result of the launch of Sumatriptan
Injection USP, continued growth of OTREXUP and significant
development revenue generated from our alliance business. In
addition, the filing of a New Drug Application for QST with an
October 2017 action date was the highlight of our successes in the
past year. We look forward to 2017 and beyond as we
anticipate the potential for a number of internal and partnered
combination drug-device product approvals over the coming
years.”
Fourth Quarter 2016 and Recent
Highlights
- Reported quarterly revenue of $14.2 million and annual revenue
of $52.2 million for the fourth quarter and full year ended
December 31, 2016.
- Submitted a New Drug Application to the U.S. Food and Drug
Administration 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 condition known
as hypogonadism. The application was subsequently accepted
and is currently under active review by the FDA with an October 20,
2017 PDUFA date.
- Announced that Teva Pharmaceutical Industries, Ltd. (Teva) had
successfully concluded a decentralized procedure registration
process in Europe for its teriparatide injection product.
Teriparatide injection marks the first product approved utilizing
Antares’ multi-dose pen technology. Teriparatide injection is
a treatment for osteoporosis in postmenopausal women and men at
increased risk of fracture and for glucocorticoid induced
osteoporosis in men and women. Applications for marketing
authorizations in Europe are ongoing in each of the countries of
application. Teva awaits final clearance of the intellectual
property on the original product.
- 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 selected for a
prestigious oral podium presentation at the 22nd Annual Fall
Scientific Meeting of the Sexual Medicine Society of North America
in November 2016. A moderated podium presentation featuring
additional data from the same study demonstrated improved
psychosexual function in hypogonadal men and was also accepted and
presented at the same meeting.
Fourth Quarter and Year End 2016
Financial Results
Revenue was $14.2 million and $52.2 million for
the three months and year ended December 31, 2016, respectively,
compared to $11.8 million and $45.7 million for the comparable
periods in 2015. 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 $9.7 million and $40.3 million for the three
months and year ended December 31, 2016, respectively, compared to
$9.0 million and $27.5 million for the comparable periods in
2015. The increase in product sales for the three months and
full year ended December 31, 2016 over the same periods in 2015 was
primarily driven by an increase in auto and pen injector sales
associated with the launch of sumatriptan injection and continued
growth of OTREXUP®.
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. Development revenue was $3.8 million and $10.2
million for the three months and year ended December 31, 2016,
respectively, compared to $0.9 million and $8.9 million for the
comparable periods in 2015.
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 $38 thousand and
$0.2 million for the three months and year ended December 31, 2016,
respectively, compared to $1.1 million and $7.2 million for the
comparable periods in 2015. The decrease in the full year
2016 licensing revenue is primarily related to final recognition of
deferred revenue in connection with the termination of our
promotion and license agreement with LEO Pharma, Inc. in June of
2015.
Royalty revenue is recognized primarily from the
in-market sales of products sold by our partners. Royalty
revenue was $0.7 million and $1.5 million for the three months and
year ended December 31, 2016, respectively, compared to $0.8
million and $2.0 million for the comparable periods in
2015.
Gross profit increased in the fourth quarter of
2016 to $7.5 million compared to $5.8 million in the same period in
2015 and decreased for the full year to $23.4 million in 2016
compared to $26.2 million in 2015, primarily due to the termination
of our promotion and license agreement with LEO Pharma,
Inc.
Operating expenses were $11.7 million and $12.3
million for the fourth quarters of 2016 and 2015, respectively, and
$47.5 million and $46.7 million for the years ended December 31,
2016 and 2015, respectively.
Net loss was $4.5 million in the fourth quarter
ended December 31, 2016 compared to $6.6 million for the same
period in 2015 and $24.3 million for the year ended December 31,
2016 compared to $20.7 million for the full year in 2015. Net
loss per share was $0.03 for the quarter ended December 31, 2016
compared to $0.04 for the same quarter in 2015. Net loss per
share was $0.16 and $0.14 for the years ended December 31, 2016 and
2015, respectively.
At December 31, 2016, cash, cash equivalents and
investments were $27.7 million compared to $47.9 million at
December 31, 2015.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review fourth quarter and full year 2016 financial results via
webcast and conference call on Tuesday, March 14, 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 1-888-542-0999 (US), or
1-719-325-2473 (International). Callers should reference the
Antares Pharma conference call or conference identification code
9686901. 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,
March 14, 2017, through 11:30 a.m. ET on Thursday, April 13, 2017.
To access the replay, callers should dial 1-888-203-1112 (US) or
1-719-457-0820 (International) and enter passcode
9686901.
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; 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 and timely 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 the development project with AMAG Pharmaceuticals for an
auto injector for Makena; 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 December
31, |
|
|
Increase |
|
|
Year Ended December
31, |
|
|
Increase |
|
|
|
2016 |
|
|
2015 |
|
|
(Decrease) |
|
|
2016 |
|
|
2015 |
|
|
(Decrease) |
|
OTREXUP® |
|
$ |
4,121 |
|
|
$ |
3,307 |
|
|
|
25 |
% |
|
|
$ |
15,145 |
|
|
$ |
13,250 |
|
|
|
14 |
% |
|
Auto injector and pen
injector devices |
|
|
3,877 |
|
|
|
4,873 |
|
|
|
(20 |
%) |
|
|
|
19,713 |
|
|
|
10,080 |
|
|
|
96 |
% |
|
Needle-free injector
devices and components |
|
|
1,740 |
|
|
|
863 |
|
|
|
102 |
% |
|
|
|
5,460 |
|
|
|
4,203 |
|
|
|
30 |
% |
|
Total product
sales |
|
|
9,738 |
|
|
|
9,043 |
|
|
|
8 |
% |
|
|
|
40,318 |
|
|
|
27,533 |
|
|
|
46 |
% |
|
Development
revenue |
|
|
3,767 |
|
|
|
868 |
|
|
|
334 |
% |
|
|
|
10,235 |
|
|
|
8,892 |
|
|
|
15 |
% |
|
Licensing revenue |
|
|
38 |
|
|
|
1,130 |
|
|
|
(97 |
%) |
|
|
|
166 |
|
|
|
7,242 |
|
(1 |
) |
|
(98 |
%) |
|
Royalties |
|
|
653 |
|
|
|
763 |
|
|
|
(14 |
%) |
|
|
|
1,503 |
|
|
|
1,991 |
|
|
|
(25 |
%) |
|
Total revenue |
|
$ |
14,196 |
|
|
$ |
11,804 |
|
|
|
20 |
% |
|
|
$ |
52,222 |
|
|
$ |
45,658 |
|
|
|
14 |
% |
|
(1) Licensing revenue for the year ended December 31, 2015
included $6.0 million recognized under a promotion and marketing
agreement with LEO Pharma, which was terminated in June 2015.
ANTARES PHARMA, INC. |
Table 2 – CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS |
(amounts in thousands except per share
amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
9,738 |
|
|
$ |
9,043 |
|
|
$ |
40,318 |
|
|
$ |
27,533 |
|
Development revenue |
|
|
3,767 |
|
|
|
868 |
|
|
|
10,235 |
|
|
|
8,892 |
|
Licensing
revenue |
|
|
38 |
|
|
|
1,130 |
|
|
|
166 |
|
|
|
7,242 |
|
Royalties |
|
|
653 |
|
|
|
763 |
|
|
|
1,503 |
|
|
|
1,991 |
|
Total
revenue |
|
|
14,196 |
|
|
|
11,804 |
|
|
|
52,222 |
|
|
|
45,658 |
|
Cost of revenue |
|
|
6,689 |
|
|
|
5,975 |
|
|
|
28,817 |
|
|
|
19,458 |
|
Gross
profit |
|
|
7,507 |
|
|
|
5,829 |
|
|
|
23,405 |
|
|
|
26,200 |
|
Research and
development |
|
|
5,572 |
|
|
|
5,642 |
|
|
|
21,127 |
|
|
|
19,731 |
|
Selling, general and
administrative |
|
|
6,155 |
|
|
|
6,677 |
|
|
|
26,395 |
|
|
|
26,931 |
|
Total
operating expenses |
|
|
11,727 |
|
|
|
12,319 |
|
|
|
47,522 |
|
|
|
46,662 |
|
Operating loss |
|
|
(4,219 |
) |
|
|
(6,490 |
) |
|
|
(24,116 |
) |
|
|
(20,462 |
) |
Other income
(expense) |
|
|
(181 |
) |
|
|
39 |
|
|
|
(122 |
) |
|
|
(22 |
) |
Net loss before income
taxes |
|
|
(4,400 |
) |
|
|
(6,451 |
) |
|
|
(24,239 |
) |
|
|
(20,484 |
) |
Income
tax provision |
|
|
100 |
|
|
|
175 |
|
|
|
100 |
|
|
|
175 |
|
Net loss |
|
$ |
(4,500 |
) |
|
$ |
(6,626 |
) |
|
$ |
(24,339 |
) |
|
$ |
(20,659 |
) |
Basic and diluted net
loss per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.14 |
) |
Basic and diluted
weighted average common shares outstanding |
|
|
155,111 |
|
|
|
154,829 |
|
|
|
154,992 |
|
|
|
146,594 |
|
ANTARES PHARMA, INC. |
Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS |
(amounts in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
27,715 |
|
|
$ |
47,911 |
|
Accounts
receivable |
|
|
9,073 |
|
|
|
7,952 |
|
Inventories |
|
|
5,327 |
|
|
|
5,724 |
|
Equipment, molds,
furniture and fixtures, net |
|
|
17,867 |
|
|
|
14,793 |
|
Patent rights, net |
|
|
2,045 |
|
|
|
2,435 |
|
Goodwill |
|
|
1,095 |
|
|
|
1,095 |
|
Other assets |
|
|
3,203 |
|
|
|
4,652 |
|
Total
Assets |
|
$ |
66,325 |
|
|
$ |
84,562 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
13,758 |
|
|
$ |
11,675 |
|
Deferred revenue |
|
|
7,349 |
|
|
|
5,844 |
|
Stockholders’
equity |
|
|
45,218 |
|
|
|
67,043 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
66,325 |
|
|
$ |
84,562 |
|
|
|
|
|
|
|
|
|
|
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
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