Antares Pharma, Inc. (NASDAQ: ATRS) (the Company) today reported
operating and financial results for the second quarter ended June
30, 2018. The Company reported revenue of $14.2 million and a
net loss per share of $0.03 for the quarter ended June 30, 2018.
“We are very pleased with the second quarter
operating and financial results and the progress we made on a
number of key initiatives. The recent launch of AMAG’s Makena auto
injector product, the addition of a rescue pen development program
to our business alliance pipeline and the potential for a late
third quarter approval of our proprietary product XYOSTED should
continue to drive additional increases in revenue going forward,”
said Robert F. Apple, President and Chief Executive Officer of the
Company. “Additionally, we continue to see a positive shift
in our revenue mix, transitioning away from development revenue
toward product revenue with a 51% increase recorded in the second
quarter versus the same period last year. We are also focused
on XYOSTED launch planning as we continue to identify highly
experienced sales representatives and stand ready to bring them on
board contingent upon product approval on the September 29, 2018
target action date.”
Second Quarter 2018 and Recent
Highlights
- Reported second quarter 2018 revenue of $14.2 million and a
loss per share of $0.03. Cash and cash equivalents were $28.8
million at June 30, 2018.
- Total product revenue of $11.1 million increased 51% over the
same period last year.
- Reported $3.9 million of combined product, royalty and
development revenue in the second quarter 2018 in connection with
AMAG’s subcutaneous Makena auto injector launch.
- Announced a Development Agreement with Pfizer Inc., to design
an undisclosed drug device rescue pen utilizing our QuickShot® auto
injector technology.
- Announced the appointment of James Tursi, M.D. to the position
of Executive Vice President, Head of Research & Development and
Chief Medical Officer.
- Received an additional $4.75 million in the second quarter from
Ferring Pharmaceuticals in connection with the previously announced
sale of the ZOMAJET™ needle-free delivery
system.
- Announced FDA accepted our resubmission to the Complete
Response Letter received in connection with the XYOSTED™ New Drug
Application. The FDA considered the resubmission to be a
complete, class 2 response and assigned a user fee goal date of
September 29, 2018.
Second Quarter and Year to Date
Financial Results
Total revenue represents revenue generated from
product sales, development revenue and royalties. Total
revenue was $14.2 million for the three months ended June 30, 2018,
compared to $13.4 million for the comparable period in 2017. For
the six months ended June 30, 2018, total revenue was $26.9
million, compared to $25.4 million for the six months ended June
30, 2017.
Product sales represent sales of our proprietary
products and devices or device components to our partners.
Product sales were $11.1 million for the three months ended June
30, 2018, compared to $7.3 million for the comparable period in
2017, a 51% increase, and were $22.0 million for the six months
ended June 30, 2018 compared to $17.4 million in the same period of
2017, a 27% increase. The increase in product sales for the
three month period was primarily driven by sales of Makena® auto
injectors to AMAG offset by lower product shipments of epinephrine
injectors to Teva and a decrease in OTREXUP® revenues. The
increase in product sales for the six month period was primarily
driven by sales of Makena® auto injectors to AMAG offset by lower
product shipments of epinephrine injectors to Teva.
Licensing and development revenue includes
license fees received from partners for the right to use our
intellectual property and amounts earned in joint development
arrangements with partners under which we perform development
activities or develop new products on their behalf. Licensing and
development revenue was $1.8 million and $5.8 million for the three
months ended June 30, 2018 and 2017, respectively, and $3.1
million and $7.4 million for the six months ended June 30,
2018 and 2017, respectively. The decrease in licensing and
development revenue for the three and six months ended
June 30, 2018 as compared to the same periods in 2017 was
principally a result of a reduction in development activities with
AMAG for the Makena® auto injector product, which was approved by
the FDA in February 2018 and is now a marketed product, and a net
reduction in licensing fees recognized.
Royalty revenue is recognized primarily from the
in-market sales of products sold by our partners. Royalty
revenue was $1.3 million for the three months ended June 30, 2018
compared to $0.3 million for the same period in 2017, and totalled
$1.8 million for the six months ended June 30, 2018 compared to
$0.6 million for the first half of 2017. The increase in
royalty revenue for the three and six month periods of 2018 was
primarily driven by in-market sales of the Makena® auto
injector product by our commercial partner AMAG
Pharmaceuticals.
Operating expenses were $11.1 million for the
second quarter of 2018 compared to $10.5 million in the comparable
period of 2017. Total operating expenses for the six months
ended June 30, 2018 were $22.2 million as compared to $21.1 million
for the same period in 2017. The increase in operating expenses for
the three and six month periods of 2018 was primarily due to
additional research and development spending associated with
potential pipeline products, and an increase in pre-launch sales
and marketing expenses associated with the potential launch of
XYOSTED®.
Net loss was $4.5 million for the second quarter
of 2018, compared to $2.8 million in the same period in 2017, and
$10.7 million for the six months ended June 30, 2018 compared to
$7.6 million in the same period of 2017. Net loss per share
was $0.03 and $0.07 for the three and six month periods ended June
30, 2018, respectively, and $0.02 and $0.05 for the comparable
periods in 2017, respectively.
The operating results for the second quarter
excluded the $4.75 million sales proceeds received from Ferring
Pharmaceuticals, which was included in deferred gain on the balance
sheet. The $4.75 million installment and any future installments
received will be recognized as a gain in future periods once it is
considered probable that a significant reversal of the gain will
not occur.
At June 30, 2018, cash, cash equivalents and
investments were $28.8 million compared to $31.6 million at
December 31, 2017.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review second quarter 2018 financial results via webcast and
conference call today, August 7, 2018, 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 “For Investors” section of the Company’s
website (www.antarespharma.com) under “Webcasts”.
Alternatively, callers may participate in the audio portion of the
conference call by dialing toll free 1-888-254-3590, or
1-323-994-2093. Callers should reference the Antares Pharma
conference call or conference identification code 4542618. Callers
can access the slide presentation on the “For Investors” section of
the Company’s website under “Presentations”. Webcast and telephone
replays of the conference call will be available from 11:30 a.m. ET
on Tuesday, August 7, 2018, through 11:30 a.m. ET on Thursday,
September 6, 2018. To access the replay, callers should dial
1-888-203-1112 or 1-719-457-0820 and enter passcode
4542618.
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused on the development and
commercialization of self-administered parenteral pharmaceutical
products using advanced drug delivery auto injection
technology. The Company has a portfolio of proprietary and
partnered commercial products with several product candidates in
advanced stages of development, as well as significant strategic
alliances with industry leading pharmaceutical companies including
Teva Pharmaceutical Industries, Ltd. (Teva) and AMAG
Pharmaceuticals, Inc. Antares Pharma’s proprietary products
include OTREXUP® (methotrexate) injection for subcutaneous use and
Sumatriptan Injection USP, which is distributed by Teva. The
Company has developed an investigational new drug for testosterone
replacement therapy called XYOSTED™, currently under active review
at the FDA with a PDUFA date of September 29, 2018.
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: timing and successful
development of the rescue pen with Pfizer and FDA approval and
future revenue from the same; successful completion of the
transaction with Ferring International Center, S.A.; the Company’s
ability to resolve the deficiencies identified by the FDA in the
Complete Response Letter for XYOSTED™, FDA
approval of the Company’s NDA for
XYOSTED™ and future market acceptance and
revenue for XYOSTED™; future market acceptance and
revenue from Makena® subcutaneous auto injector; Teva’s ability to
successfully commercialize VIBEX® Sumatriptan Injection USP and the
amount of revenue from the same; continued growth of prescriptions
and sales of OTREXUP®; the timing and results of the
Company’s or its partners’ research projects or clinical trials of
product candidates in development; actions by the FDA or other
regulatory agencies with 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, 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.
Contact:Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
TABLES FOLLOW
|
|
ANTARES PHARMA, INC. |
Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS |
(amounts in thousands except per share
amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
June 30, |
|
|
Increase |
|
|
2018 |
|
|
2017 |
|
|
(Decrease) |
|
|
2018 |
|
|
2017 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
11,095 |
|
|
$ |
7,344 |
|
|
51 |
% |
|
|
$ |
22,044 |
|
|
$ |
17,381 |
|
|
27 |
% |
Licensing
and development revenue |
|
|
1,785 |
|
|
|
5,807 |
|
|
(69 |
%) |
|
|
|
3,070 |
|
|
|
7,447 |
|
|
(59 |
%) |
Royalties |
|
|
1,282 |
|
|
|
265 |
|
|
384 |
% |
|
|
|
1,751 |
|
|
|
595 |
|
|
194 |
% |
Total
revenue |
|
|
14,162 |
|
|
|
13,416 |
|
|
6 |
% |
|
|
|
26,865 |
|
|
|
25,423 |
|
|
6 |
% |
Cost of Revenue |
|
|
6,960 |
|
|
|
5,617 |
|
|
24 |
% |
|
|
|
14,146 |
|
|
|
11,836 |
|
|
20 |
% |
Gross
profit |
|
|
7,202 |
|
|
|
7,799 |
|
|
(8 |
%) |
|
|
|
12,719 |
|
|
|
13,587 |
|
|
(6 |
%) |
Research and
development |
|
|
3,650 |
|
|
|
3,159 |
|
|
16 |
% |
|
|
|
6,970 |
|
|
|
6,246 |
|
|
12 |
% |
Selling, general and
administrative |
|
|
7,463 |
|
|
|
7,360 |
|
|
1 |
% |
|
|
|
15,279 |
|
|
|
14,827 |
|
|
3 |
% |
Total
operating expenses |
|
|
11,113 |
|
|
|
10,519 |
|
|
6 |
% |
|
|
|
22,249 |
|
|
|
21,073 |
|
|
6 |
% |
Operating loss |
|
|
(3,911 |
) |
|
|
(2,720 |
) |
|
44 |
% |
|
|
|
(9,530 |
) |
|
|
(7,486 |
) |
|
27 |
% |
Other expense |
|
|
(609 |
) |
|
|
(120 |
) |
|
408 |
% |
|
|
|
(1,183 |
) |
|
|
(90 |
) |
|
1214 |
% |
Net loss |
|
$ |
(4,520 |
) |
|
$ |
(2,840 |
) |
|
59 |
% |
|
|
$ |
(10,713 |
) |
|
$ |
(7,576 |
) |
|
41 |
% |
Basic and diluted net
loss per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
$ |
(0.07 |
) |
|
$ |
(0.05 |
) |
|
|
Basic and diluted
weighted average common shares outstanding |
|
|
157,024 |
|
|
|
155,926 |
|
|
|
|
|
|
156,875 |
|
|
|
155,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA, INC. |
|
Table 2 – CONSOLIDATED CONDENSED BALANCE
SHEETS |
|
(amounts in thousands) |
|
(unaudited) |
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
28,782 |
|
|
$ |
31,555 |
|
Accounts
receivable |
|
|
14,072 |
|
|
|
11,878 |
|
Inventories |
|
|
10,680 |
|
|
|
9,275 |
|
Equipment, molds,
furniture and fixtures, net |
|
|
15,569 |
|
|
|
16,158 |
|
Patent rights, net |
|
|
1,133 |
|
|
|
1,401 |
|
Goodwill |
|
|
1,095 |
|
|
|
1,095 |
|
Other assets |
|
|
2,474 |
|
|
|
2,976 |
|
Total
Assets |
|
$ |
73,805 |
|
|
$ |
74,338 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
15,640 |
|
|
$ |
12,939 |
|
Deferred gain |
|
|
7,500 |
|
|
|
— |
|
Deferred revenue |
|
|
1,027 |
|
|
|
2,994 |
|
Long-term debt |
|
|
24,992 |
|
|
|
24,858 |
|
Stockholders’
equity |
|
|
24,646 |
|
|
|
33,547 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
73,805 |
|
|
$ |
74,338 |
|
|
|
|
|
|
|
|
|
|
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