Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), today reported
operating and financial results for the first quarter ended March
31, 2020 with record first quarter revenue of $33.1 million and a
net loss per share of $0.01.
“Our first quarter revenue performance
underscores the strength of our commercial and operations
organizations at a time when COVID-19 impacted the global economy
and our business during the last month of the quarter. XYOSTED
recorded another quarter of double-digit prescription growth over
the prior quarter driven once again by a significant increase in
both patients and prescribers. We continue to believe XYOSTED
represents the most effective option for treating low testosterone
in hypogonadal men, especially in an at-home treatment setting. On
the partnered product front where we provide devices, Teva achieved
a thirteen percent increase in generic epipen prescriptions in the
first quarter of 2020 versus the fourth quarter of 2019 and
importantly achieved a seven percent increase in market share over
the same period,” said Robert F. Apple, President and Chief
Executive Officer of the Company. “With respect to the COVID-19
pandemic, we continue to monitor this global health crisis as it
relates to our ongoing operations, and we have taken various steps
to potentially reduce the impact of the pandemic on our business.
Antares is focused on helping to ensure patients continue to have
access to our medicines while protecting the health and well-being
of both our employees and our customers. At this time, while we
have seen a softening in new patient starts for our products, it is
difficult to predict the full financial impact on our business
given the current economic slowdown and uncertainty surrounding the
duration of the pandemic. However, we believe the Company is in a
strong financial position, allowing us to navigate through these
unprecedented times while continuing to execute on our key
strategic objectives supporting long-term growth.”
First Quarter 2020 and Recent
Highlights
- Reported first quarter total 2020
revenue of $33.1 million, an increase of 42% compared to the same
period last year. Proprietary product revenue increased 163% to
$12.6 million as compared to the $4.8 million reported in the first
quarter of 2019. Partnered product revenue increased 7.4% to $14.5
million compared to $13.5 million in the first quarter of
2019.
- XYOSTED® total prescriptions
increased 18% sequentially versus the fourth quarter of 2019. To
date, more than one hundred thousand prescriptions of XYOSTED® have
been written by approximately fifty three hundred different
physicians.
- Reported first quarter 2020 loss
per share of $0.01 as compared to a $0.03 loss per share reported
in the comparable period last year.
- Generated $5.6 million in cash from
operating activities during the first quarter of 2020. Our total
cash, cash equivalents and short-term investments increased to
$50.3 million at March 31, 2020, compared to $45.7 million at
December 31, 2019.
First Quarter 2020 Financial
Results
Total revenue generated from product sales,
development activities and royalties was $33.1 million for the
three months ended March 31, 2020, compared to $23.3 million for
the comparable period in 2019, a 42% increase.
Product sales were $27.1 million for the three
months ended March 31, 2020, compared to $18.3 million for the
comparable period in 2019, a 48% increase.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $12.6 million for the three months
ended March 31, 2020 as compared to $4.8 million for the three
months ended March 31, 2019, a 163% increase. The increase in
proprietary product sales for the three months ended March 31, 2020
as compared to the three months ended March 31, 2019 was
attributable to XYOSTED®.
We sell devices, components and fully assembled
and packaged product to our partners Teva and AMAG. Partnered
product sales were $14.5 million for the three months ended March
31, 2020 as compared to $13.5 million for the comparable period
last year. The increase in sales of partnered products for the
three months ended March 31, 2020 as compared to the same period in
2019 is primarily attributable to sales of auto injector devices to
Teva for use with their Epinephrine Injection USP.
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 for the three month period
ended March 31, 2020 compared to $0.9 million for the comparable
period in 2019. The increase in licensing and development revenue
for the first quarter of 2020 was due to work performed on the
Pfizer rescue pen and the Idorsia selatogrel pen development
programs.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalty revenue was $4.2
million for the three months ended March 31, 2020 compared to $4.1
million for the same period in 2019. The net increase in royalty
revenue for the three month period was a result of an overall
increase of $1.9 million in royalties received from Teva on their
net sales of Epinephrine Injection USP, offset by a decrease of
$1.5 million in royalties received from AMAG on their net sales of
the Makena® subcutaneous auto injector.
Operating expenses were $19.4 million for the
first quarter of 2020 compared to $17.3 million in the comparable
period of 2019. The increase in operating expenses in the first
quarter of 2020 was primarily due to incremental sales and
marketing expenses related to the commercialization of
XYOSTED®.
Net loss was $2.4 million for the first quarter
of 2020, compared to $5.5 million in the comparable period in 2019.
Net loss per share was $0.01 for the quarter ended March 31, 2020
and $0.03 for the quarter ended March 31, 2019.
At March 31, 2020, cash, cash equivalents and
short term investments were $50.3 million compared to $45.7 million
at December 31, 2019.
2020 Financial Guidance
Due to uncertainties caused by the ongoing
COVID-19 pandemic, including the impact and duration of
shelter-in-place restrictions and a lack of access for certain
patients to their physicians’ offices, Antares is suspending the
previously announced 2020 net revenue guidance.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review first quarter 2020 financial results via webcast and
conference call today, May 5, 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 6655382. 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, May 5, 2020 through 11:30 a.m. ET on
Thursday, June 4, 2020. To access the replay, callers should dial
1-888-203-1112 or 1-719-457-0820 and enter passcode 6655382.
About Antares Pharma
Antares Pharma, Inc. is a pharmaceutical
technology company focused primarily on the development and
commercialization of self-administered injectable 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 FDA approved 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: the uncertainty regarding the
duration, scope and severity of the COVID-19 pandemic and the
mitigation measures and other restrictions implemented in response
to the same and the impact on demand for our products, new patients
and prescriptions, future revenue, product supply, and our overall
business, operating results and financial condition; 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 |
|
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
27,097 |
|
|
$ |
18,300 |
|
|
48 |
% |
|
Licensing and development revenue |
|
|
1,755 |
|
|
|
915 |
|
|
92 |
% |
|
Royalties |
|
|
4,227 |
|
|
|
4,071 |
|
|
4 |
% |
|
Total revenue |
|
|
33,079 |
|
|
|
23,286 |
|
|
42 |
% |
|
Cost of Revenue |
|
|
15,047 |
|
|
|
10,946 |
|
|
37 |
% |
|
Gross profit |
|
|
18,032 |
|
|
|
12,340 |
|
|
46 |
% |
|
Research and development |
|
|
2,981 |
|
|
|
2,387 |
|
|
25 |
% |
|
Selling, general and administrative |
|
|
16,422 |
|
|
|
14,935 |
|
|
10 |
% |
|
Total operating expenses |
|
|
19,403 |
|
|
|
17,322 |
|
|
12 |
% |
|
Operating loss |
|
|
(1,371 |
) |
|
|
(4,982 |
) |
|
(72 |
)% |
|
Other income (expense), net |
|
|
(985 |
) |
|
|
(557 |
) |
|
77 |
% |
|
Net loss |
|
$ |
(2,356 |
) |
|
$ |
(5,539 |
) |
|
(57 |
)% |
|
Basic and diluted net loss per common share |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
Basic and diluted weighted average common shares
outstanding |
|
|
165,429 |
|
|
|
160,446 |
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
|
Three Months EndedMarch 31, |
|
|
|
2020 |
|
|
2019 |
|
Product sales: |
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
9,003 |
|
|
$ |
703 |
|
OTREXUP® |
|
|
3,563 |
|
|
|
4,068 |
|
Partnered product sales |
|
|
14,531 |
|
|
|
13,529 |
|
Total product sales |
|
$ |
27,097 |
|
|
$ |
18,300 |
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
March 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
50,317 |
|
|
$ |
45,721 |
|
Accounts receivable |
|
|
31,412 |
|
|
|
35,074 |
|
Inventories |
|
|
17,309 |
|
|
|
16,000 |
|
Contract assets |
|
|
9,929 |
|
|
|
8,235 |
|
Equipment, molds, furniture and
fixtures, net |
|
|
16,223 |
|
|
|
15,961 |
|
Goodwill, intangibles and
right-of use assets |
|
|
6,736 |
|
|
|
7,036 |
|
Other assets |
|
|
4,878 |
|
|
|
4,724 |
|
Total Assets |
|
$ |
136,804 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
35,213 |
|
|
$ |
30,677 |
|
Deferred revenue |
|
|
2,048 |
|
|
|
1,738 |
|
Long-term debt and lease
liabilities |
|
|
45,745 |
|
|
|
45,836 |
|
Stockholders’ equity |
|
|
53,798 |
|
|
|
54,500 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
136,804 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
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