Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”) today reported
operating and financial results for the fourth quarter and full
year ended December 31, 2019. The Company reported total revenue of
$37.8 million for the fourth quarter of 2019 and $123.9 million for
the year ended December 31, 2019. Net income per share was $0.03
for the fourth quarter of 2019 and a net loss per share of $0.01
for the year ended December 31, 2019.
“Our evolution as a pharmaceutical technology
company continued in 2019, as we delivered record revenue and the
Company’s first full year of operating income. Our revenue of
almost $124 million and first time annual operating income was
driven by the successful launch of our proprietary product XYOSTED
and Teva’s generic epipen,” said Robert F. Apple, President and
Chief Executive Officer of the Company. “We believe the
XYOSTED launch exceeded expectations, solidifying our commercial
effectiveness, and that our operational capabilities contributed to
the success of the generic epipen launch. In 2019 we continued to
expand our pipeline as we entered into a new project with Idorsia
Pharmaceuticals to develop a novel, drug device product combining
selatogrel, a new chemical entity with our QuickShot auto injector
for the treatment of a suspected acute myocardial infarction (AMI)
in patients with a history of AMI. As we look ahead to 2020, we
believe our strong financial position and established commercial
operations provide a foundation to help fuel continued growth of
XYOSTED and progress of our pipeline.”
Fourth Quarter 2019 and Recent
Highlights
- Reported fourth quarter 2019 revenue of $37.8 million, an
increase of 101% compared to the same period last year. Generated
fourth quarter product revenue of $28.5 million, an increase of
100% compared to the same period last year. Fourth quarter royalty
revenue was $6.2 million as compared to $3.5 million reported in
the same period last year, a 78% increase. Cash, cash equivalents
and short-term investments were $45.7 million at December 31, 2019,
as compared to $41.9 million at September 30, 2019 and $27.9
million at December 31, 2018.
- Reported fourth quarter 2019 earnings per share of $0.03. This
represents the Company’s second consecutive quarterly income from
ongoing operations.
- Announced a global agreement with Idorsia Pharmaceuticals Ltd.
to develop a novel, drug-device product combining selatogrel,
Idorsia’s potent, fast-acting and highly selective P2Y12 receptor
antagonist under development, with the Antares subcutaneous
QuickShot® auto injector. Selatogrel, a new chemical entity, is
being developed for the treatment of a suspected acute myocardial
infarction (AMI) in adult patients with a history of AMI.
- Announced full year 2020 net revenue guidance of $135 to $155
million, which includes a range of potential revenue scenarios for
AMAG’s Makena® subcutaneous auto injector product.
Fourth Quarter and Year-to-Date
Financial Results
Total revenue represents revenue generated from
product sales, development activities and royalties. Total revenue
was $37.8 million for the three months ended December 31, 2019,
compared to $18.8 million for the comparable period in 2018, a 101%
increase. For the year ended December 31, 2019, total revenue was
$123.9 million, compared to $63.6 million for the comparable period
in 2018, a 95% increase.
Product sales were a record $28.5 million for
the three months ended December 31, 2019, compared to $14.2 million
for the comparable period in 2018, a 100% increase. For the year
ended December 31, 2019, product sales were $92.1 million, compared
to $47.9 million for the comparable period in 2018, a 92% increase.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $14.0 million and $39.2 million for
the three and twelve months ended December 31, 2019, respectively,
as compared to $5.7 million and $17.5 million for the three and
twelve months ended December 31, 2018, respectively. The increase
in proprietary product sales for the three and twelve months ended
December 31, 2019 as compared to the three and twelve months ended
December 31, 2018 was principally attributable to sales of
XYOSTED®, which was launched in late 2018.
We sell devices, components and fully assembled
and packaged product to our partners Teva, AMAG and Ferring
Pharmaceuticals. Partnered product sales were $14.5 million and
$8.5 million for the three months ended December 31, 2019 and 2018,
respectively, and $52.9 million and $30.3 million for the year
ended December 31, 2019 and 2018, respectively. The increase in
sales of partnered products for the three and twelve months ended
December 31, 2019 as compared to the same period in 2018 is
primarily attributable to sales of auto injector devices to Teva
for use with their Epinephrine Injection USP. With the final
payment received in October of 2019 related to the sale of our
needle-free device to Ferring, we will no longer manufacture and
supply needle free devices going forward.
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 $3.2 million and $7.5 million for the three
and twelve month periods ended December 31, 2019, respectively,
compared to $1.1 million and $6.8 million for the comparable
periods in 2018, respectively. Licensing and development revenue
for the three and twelve month periods was primarily from the
Pfizer rescue pen and Teva pen development programs.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalty revenue was $6.2
million for the three months ended December 31, 2019 compared to
$3.5 million for the same period in 2018, a 78% increase. For the
twelve month period ended December 31, 2019, royalty revenue was
$24.2 million, compared to $8.9 million for the comparable period
in 2018, a 171% increase. The significant increases in royalty
revenue for the three and twelve month periods were primarily
attributable to royalties recognized from Teva on their net sales
of Epinephrine Injection USP and from AMAG on their net sales of
the Makena® subcutaneous auto injector.
Operating expenses were $18.2 million for the
fourth quarter of 2019 compared to $14.9 million in the comparable
period of 2018. Total operating expenses for the twelve months
ended December 31, 2019 were $72.4 million as compared to $49.1
million for the comparable period in 2018. The increase in
operating expenses for the three and twelve month periods of 2019
was primarily attributable to additional sales and marketing
expenses associated with the launch of XYOSTED®.
Operating income was $5.6 million for the fourth
quarter of 2019 compared to $6.8 million in the comparable period
of 2018. Total operating income for the twelve months ended
December 31, 2019 was $1.0 million as compared to an operating loss
of $4.1 million for the twelve months ended December 31, 2018. Net
income was $4.7 million for the fourth quarter of 2019, compared to
$6.1 million for the fourth quarter of 2018. Net loss was $2.0
million for the twelve months ended December 31, 2019 as compared
to $6.5 million for the twelve months ended December 31, 2018. Net
income per share was $0.03 and $0.04 for the three month periods
ended December 31, 2019 and 2018, respectively, and net loss per
share was $0.01 and $0.04 for the twelve month periods ended
December 31, 2019 and 2018, respectively. The three and twelve
month periods ended December 31, 2018 reflected a $12.5 million
gain recognized from the sale of our needle free product line to
Ferring Pharmaceuticals.
At December 31, 2019, cash, cash equivalents and
short-term investments were $45.7 million compared to $27.9 million
at December 31, 2018. During the second quarter of 2019, the
Company amended the existing loan and security agreement with
Hercules Capital and borrowed an additional $15.0 million upon
execution of the agreement.
2020 Financial Guidance
The Company previously issued 2020 net revenue
guidance to be in a range of $135 to $155 million.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review fourth quarter 2019 financial results via webcast and
conference call today, March 3, 2020, 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 1-800-367-2403,
or 1-334-777-6978. Callers should reference the Antares Pharma
conference call or conference identification code 4919542. 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 Tuesday, March 3, 2020 through 11:30 a.m. ET on
Thursday, April 2, 2020. To access the replay, callers should dial
1-888-203-1112 or 1-719-457-0820 and enter passcode
4919542.
About Antares Pharma
Antares Pharma, Inc. is a pharmaceutical
technology company focused primarily 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 various stages of
development, as well as significant strategic alliances with
industry leading pharmaceutical companies including Teva
Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc.
(AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd.
(Idorsia). 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: achievement of the Company’s 2020
revenue guidance; market acceptance, adequate reimbursement
coverage and commercial success of XYOSTED® and future revenue from
the same; successful development including the timing and results
of the clinical bridging and Phase 3 clinical trial of the drug
device combination product for Selatogrel with Idorsia
Pharmaceuticals and FDA and global regulatory approvals and future
revenue from the same; market acceptance of Teva’s generic
epinephrine auto-injector product and future revenue from the same;
our expectations regarding whether the FDA will pursue withdrawal
of approval for AMAG Pharmaceuticals Inc.’s Makena® subcutaneous
auto injector following the recent FDA advisory committee meeting
and future prescriptions, 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 meet loan extension and interest only payment milestones and the
ability to repay the debt obligation to Hercules Capital; 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 |
|
|
|
|
|
For the Year Ended |
|
|
|
|
|
December 31, |
|
|
Increase |
|
|
December 31, |
|
|
Increase |
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
28,496 |
|
|
$ |
14,229 |
|
|
100 |
% |
|
|
$ |
92,103 |
|
|
$ |
47,870 |
|
|
92 |
% |
Licensing and development revenue |
|
|
3,164 |
|
|
|
1,129 |
|
|
180 |
% |
|
|
|
7,529 |
|
|
|
6,753 |
|
|
11 |
% |
Royalties |
|
|
6,179 |
|
|
|
3,463 |
|
|
78 |
% |
|
|
|
24,232 |
|
|
|
8,931 |
|
|
171 |
% |
Total revenue |
|
|
37,839 |
|
|
|
18,821 |
|
|
101 |
% |
|
|
|
123,864 |
|
|
|
63,554 |
|
|
95 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
14,026 |
|
|
|
9,630 |
|
|
46 |
% |
|
|
|
50,475 |
|
|
|
31,065 |
|
|
62 |
% |
Gross profit |
|
|
23,813 |
|
|
|
9,191 |
|
|
159 |
% |
|
|
|
73,389 |
|
|
|
32,489 |
|
|
126 |
% |
Research and development |
|
|
2,880 |
|
|
|
3,007 |
|
|
(4 |
%) |
|
|
|
10,624 |
|
|
|
12,328 |
|
|
(14 |
%) |
Selling, general and
administrative |
|
|
15,366 |
|
|
|
11,896 |
|
|
29 |
% |
|
|
|
61,773 |
|
|
|
36,762 |
|
|
68 |
% |
Total operating expenses |
|
|
18,246 |
|
|
|
14,903 |
|
|
22 |
% |
|
|
|
72,397 |
|
|
|
49,090 |
|
|
47 |
% |
Gain on sale of assets |
|
|
— |
|
|
|
12,500 |
|
|
(100 |
%) |
|
|
|
— |
|
|
|
12,500 |
|
|
(100 |
%) |
Operating income (loss) |
|
|
5,567 |
|
|
|
6,788 |
|
|
(18 |
%) |
|
|
|
992 |
|
|
|
(4,101 |
) |
|
** |
Other expense |
|
|
(872 |
) |
|
|
(654 |
) |
|
33 |
% |
|
|
|
(3,019 |
) |
|
|
(2,414 |
) |
|
25 |
% |
Net income (loss) |
|
$ |
4,695 |
|
|
$ |
6,134 |
|
|
|
|
|
$ |
(2,027 |
) |
|
$ |
(6,515 |
) |
|
|
Net income (loss) per common
share, basic and diluted |
|
$ |
0.03 |
|
|
$ |
0.04 |
|
|
|
|
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
Three Months EndedDecember
31, |
|
|
For the Year EndedDecember
31, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
$ |
8,423 |
|
|
$ |
649 |
|
|
$ |
20,769 |
|
|
$ |
649 |
|
OTREXUP® |
|
5,579 |
|
|
|
5,063 |
|
|
|
18,446 |
|
|
|
16,883 |
|
Partnered product sales |
|
14,494 |
|
|
|
8,517 |
|
|
|
52,888 |
|
|
|
30,338 |
|
Total product sales |
$ |
28,496 |
|
|
$ |
14,229 |
|
|
$ |
92,103 |
|
|
$ |
47,870 |
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
December 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
45,721 |
|
|
$ |
27,892 |
Accounts receivable |
|
|
35,074 |
|
|
|
18,976 |
Inventories |
|
|
16,000 |
|
|
|
11,350 |
Contract assets |
|
|
8,235 |
|
|
|
10,442 |
Equipment, molds, furniture
and fixtures, net |
|
|
15,961 |
|
|
|
14,895 |
Goodwill, intangibles and
right-of use assets |
|
|
7,036 |
|
|
|
1,926 |
Other assets |
|
|
4,724 |
|
|
|
2,796 |
Total Assets |
|
$ |
132,751 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
29,428 |
|
|
$ |
23,132 |
Deferred revenue |
|
|
1,738 |
|
|
|
1,018 |
Long-term debt and lease
liabilities |
|
|
47,085 |
|
|
|
25,126 |
Stockholders’ equity |
|
|
54,500 |
|
|
|
39,001 |
Total Liabilities and Stockholders’ Equity |
|
$ |
132,751 |
|
|
$ |
88,277 |
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