Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”) today reported
operating and financial results for the first quarter ended March
31, 2019. The Company reported revenue of $23.3 million and a
net loss per share of $0.03 for the quarter ended March 31, 2019.
“The record revenue we reported today marks the
start of what we believe will be an extraordinary year for
Antares. We believe the significant growth in revenue
validates our strategy to focus on the development of both
propriety and partnered products.” said Robert F. Apple, President
and Chief Executive Officer of the Company. “This strategy
provided six commercial products currently on the market, all
contributing to our top-line growth. Our four partnered
products with Teva, AMAG and Ferring leverages their commercial
experience and infrastructure which allows us to solely focus on
the success of XYOSTED and OTREXUP. The XYOSTED launch is off
to a strong start with month over month prescription growth since
launch. Over time, we believe that revenue from XYOSTED will
increase and become a significant contributor to our expanding and
diversified commercial business.”
First Quarter 2019 and Recent
Highlights
- Reported first quarter 2019 revenue
of $23.3 million, an increase of 83% compared to the same period
last year. Generated first quarter product revenue of $18.3
million, an increase of 67% compared to the same period last
year. First quarter royalty revenue was $4.1 million as
compared to $0.5 million reported in the same period last year, a
768% increase. Cash and cash equivalents were $23.2 million
at March 31, 2019.
- Announced receipt of orphan drug
designation to evaluate the use of subcutaneous methotrexate for
the treatment of ectopic pregnancy. The Company plans to
design a development program utilizing a proprietary auto injector
device with doses of methotrexate not commercially approved or
available in an auto injector.
- Appointed Dr. Karen Smith to the
Antares Board of Directors, filling the seat vacated by the
retirement of Dr. Jacques Gonella. Dr. Smith has over 20
years of biopharmaceutical industry experience in the United
States, Europe, Canada and Asia, and currently serves as Chief
Executive Officer for Eliminate Cancer (ECI), a cutting-edge
oncology R&D and venture organization.
First Quarter 2019 Financial
Results
Total revenue represents revenue generated from
product sales, development activities and royalties. Total
revenue was $23.3 million for the three months ended March 31,
2019, compared to $12.7 million for the comparable period in 2018,
an 83% increase.
Product sales represent sales of our proprietary
products and devices or device components to our partners.
Product sales were $18.3 million for the three months ended March
31, 2019, compared to $10.9 million for the comparable period in
2018. The 67% increase in product revenue was primarily
driven by sales of auto injector devices for use with Teva’s
generic epinephrine product, needle-free devices to Ferring,
multi-dose pens for use in Teva’s generic teriparatide product,
XYOSTED™ and Sumatriptan Injection USP, offset by a decrease in
pre-launch inventory stocking of Makena® auto injectors to
AMAG.
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 $0.9 million for the three months ended
March 31, 2019, compared to $1.3 million for the comparable period
in 2018. The decrease in development revenue was primarily 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. First quarter
2019 development revenue was primarily related to the Teva
teriparatide development program as well as the development program
with Pfizer.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalty revenue was
$4.1 million for the three months ended March 31, 2019 compared to
$0.5 million for the same period in 2018, a 768% increase.
The significant increase in royalties for the first quarter of 2019
was attributable to increased royalties from AMAG’s Makena® auto
injector product and Teva’s generic epinephrine product, which was
launched in limited commercial quantities in the fourth quarter of
2018.
Operating expenses were $17.3 million for the
first quarter of 2019 compared to $11.1 million in the comparable
period of 2018. The increase in operating expenses in the
first quarter of 2019 was primarily due to additional sales and
marketing expenses associated with the launch of XYOSTED®.
Net loss was $5.5 million for the first quarter
of 2019, compared to $6.2 million in the comparable period in
2018. Net loss per share was $0.03 for the quarter ended
March 31, 2019 and $0.04 for the quarter ended March 31, 2018.
At March 31, 2019, cash and cash equivalents
were $23.2 million compared to $27.9 million at December 31, 2018.
During the first quarter of 2019, we generated $8.1 million in
gross proceeds from the sale of common stock at an average price of
$3.51 per share through the previously established at-the-market
equity offering program, or ATM.
2019 Financial Guidance
The Company reaffirms total revenue guidance of
$95.0 million to $105.0 million for 2019.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review first quarter 2019 financial results via webcast and
conference call today, May 2, 2019, 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 & Presentations”.
Alternatively, callers may participate in the audio portion of the
conference call by dialing toll free 1-800-458-4121, or
1-323-794-2597. Callers should reference the Antares Pharma
conference call or conference identification code 2251670. Callers
can access the slide presentation on the “For Investors” section of
the Company’s website under “Webcasts & Presentations”. A
telephone replay of the conference call will be available from
11:30 a.m. ET on Thursday, May 2, 2019 through 11:30 a.m. ET on
Saturday, June 1, 2019. To access the replay, callers should dial
1-888-203-1112 or 1-719-457-0820 and enter passcode 2251670.
About Antares Pharma
Antares Pharma, Inc. is a combination drug
device company focused on the development and commercialization of
self-administered parenteral pharmaceutical products using advanced
drug delivery auto injector 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), AMAG Pharmaceuticals, Inc. and Pfizer Inc.
(Pfizer). Antares Pharma’s proprietary products include
XYOSTED™ (testosterone enanthate) injection, OTREXUP®
(methotrexate) injection for subcutaneous use and Sumatriptan
Injection USP, which is distributed by Teva.
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: market acceptance,
adequate reimbursement coverage and commercial success of XYOSTED™
and future revenue from the same; market acceptance of Teva’s
generic epinephrine auto-injector product and future revenue from
the same; successful completion of the transaction with Ferring
International Center, S.A.; 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 including projects with Teva and
Pfizer and our proprietary programs for ATRS-1701 and our
development program for the use of subcutaneous methotrexate for
the treatment of ectopic pregnancy; 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; achievement of the 2019
revenue guidance; 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 |
|
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
18,300 |
|
|
$ |
10,949 |
|
|
67 |
% |
|
Licensing and development
revenue |
|
|
915 |
|
|
|
1,285 |
|
|
(29 |
)% |
|
Royalties |
|
|
4,071 |
|
|
|
469 |
|
|
768 |
% |
|
Total revenue |
|
|
23,286 |
|
|
|
12,703 |
|
|
83 |
% |
|
Cost of Revenue |
|
|
10,946 |
|
|
|
7,186 |
|
|
52 |
% |
|
Gross profit |
|
|
12,340 |
|
|
|
5,517 |
|
|
124 |
% |
|
Research and development |
|
|
2,387 |
|
|
|
2,900 |
|
|
(18 |
)% |
|
Selling, general and administrative |
|
|
14,935 |
|
|
|
8,236 |
|
|
81 |
% |
|
Total operating expenses |
|
|
17,322 |
|
|
|
11,136 |
|
|
56 |
% |
|
Operating loss |
|
|
(4,982 |
) |
|
|
(5,619 |
) |
|
(11 |
)% |
|
Other income (expense), net |
|
|
(557 |
) |
|
|
(574 |
) |
|
(3 |
)% |
|
Net loss |
|
$ |
(5,539 |
) |
|
$ |
(6,193 |
) |
|
(11 |
)% |
|
Basic and diluted net loss per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
Basic and diluted weighted average common shares
outstanding |
|
|
160,446 |
|
|
|
156,724 |
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
March 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
23,238 |
|
|
$ |
27,892 |
|
Accounts receivable |
|
|
29,772 |
|
|
|
18,976 |
|
Inventories |
|
|
13,378 |
|
|
|
11,350 |
|
Contract assets |
|
|
9,445 |
|
|
|
10,442 |
|
Equipment, molds,
furniture and fixtures, net |
|
|
15,100 |
|
|
|
14,895 |
|
Goodwill, intangibles and
right-of-use assets |
|
|
3,693 |
|
|
|
1,926 |
|
Other assets |
|
|
4,159 |
|
|
|
2,796 |
|
Total
Assets |
|
$ |
98,785 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
27,466 |
|
|
$ |
23,132 |
|
Other current
liabilities |
|
|
7,336 |
|
|
|
4,061 |
|
Long-term liabilities |
|
|
21,315 |
|
|
|
22,083 |
|
Stockholders’ equity |
|
|
42,668 |
|
|
|
39,001 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
98,785 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
|
|
|
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Sep 2023 to Sep 2024