Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”) today reported
operating and financial results for the second quarter ended June
30, 2019. The Company reported revenue of $28.4 million and a
net loss per share of $0.01 for the quarter ended June 30,
2019. The Company also reported record six-month year-to-date
revenue of $51.7 million.
“Our second quarter and year-to-date revenue
growth is a terrific example of how Antares, as both a pharma
company with proprietary products and as a valuable device partner
to other pharma companies, is delivering results in both core areas
of our business,” said Robert F. Apple, President and Chief
Executive Officer of the Company. “We had an outstanding
second quarter and first half of 2019 as we continue to build a
diverse revenue stream fueled by recently launched XYOSTED, the
generic epipen, the Makena auto injector and royalty revenue that
have combined to propel our growth for the quarter.” Mr.
Apple added, “Our commercial organization is executing on the
XYOSTED launch plan and I am pleased to report that we have
recorded monthly double-digit percentage prescription increases
since launch. We are executing on our strategy to drive top-line
revenue growth from a diverse business mix and we believe this
growth trend will continue and is why we are increasing our
full-year 2019 revenue guidance.”
Second Quarter 2019 and Recent
Highlights
- Reported second quarter 2019
revenue of $28.4 million, an increase of 101% compared to the same
period last year. Generated second quarter product revenue of
$20.6 million, an increase of 86% compared to the same period last
year. Second quarter royalty revenue was $5.6 million as
compared to $1.3 million reported in the same period last year, a
335% increase. Cash and cash equivalents were $40.2 million
at June 30, 2019.
- Received $2.5 million in the second
quarter from Ferring Pharmaceuticals in connection with the
previously announced sale of the ZOMAJET™ needle-free delivery
system. The Company anticipates closing the transaction and
receiving the final installment of $2.5 million in the second half
of 2019. The gain on the sale of the needle free product line
was previously recorded in the fourth quarter of 2018.
- Executed an amendment to the
existing loan and security agreement with Hercules Capital Inc. to
increase the available debt capital by $25 million for a term loan
of up to $50 million. The first tranche of $25 million was
funded upon execution of the original loan agreement in June 2017
and a second tranche of $15 million was funded upon execution of
the amended agreement in June 2019, for a total of $40
million.
- Terminated the At-The-Market
(“ATM”) equity offering facility effective July 6, 2019. The
Company did not utilize the ATM in the second quarter of
2019.
- Entered into a new lease agreement
for office, laboratory, manufacturing and warehousing space in
Minnesota to support the strategic growth initiatives of the
Company.
Second Quarter and Year-to-Date
Financial Results
Total revenue represents revenue generated from
product sales, development activities and royalties. Total
revenue was $28.4 million for the three months ended June 30, 2019,
compared to $14.2 million for the comparable period in 2018, a 101%
increase. For the six months ended June 30, 2019, total
revenue was $51.7 million, compared to $26.9 million for the
comparable period in 2018, a 93% increase.
Product sales represent sales of our proprietary
products and devices or device components to our partners.
Product sales were $20.6 million for the three months ended June
30, 2019, compared to $11.1 million for the comparable period in
2018, an 86% increase. For the six month period ended June
30, 2019, product sales were $38.9 million, compared to $22.0
million for the comparable period in 2018, a 77% increase.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $9.0 million and $13.8 million for
the three and six months ended June 30, 2019, respectively, as
compared to $3.8 million and $7.7 million for the three and six
months ended June 30, 2018, respectively. The increase in
proprietary product sales for the three and six months ended
June 30, 2019 as compared to the three and six months ended
June 30, 2018 were principally attributable to sales of
XYOSTED®, which was launched for commercial sale in late
2018.
We sell devices, components and fully assembled
and packaged product to our partners Teva, AMAG and Ferring.
Partnered product sales were $11.6 million and $7.3 million for the
three months ended June 30, 2019 and 2018, respectively, and
$25.2 million and $14.3 million for the six months ended June 30,
2019 and 2018, respectively. The increase in sales of partnered
products for the three and six months ended June 30, 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, an increase in sales of Sumatriptan
Injection USP and teriparatide pen injector devices to Teva, and
sales of needle-free devices to Ferring. We will stop supplying
needle-free devices after the completion of the Ferring
transaction, which is expected to close in the second half of
2019.
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 $2.2 million and $3.2 million for the
three and six month periods ended June 30, 2019, respectively,
compared to $1.8 million and $3.0 million for the comparable
periods in 2018, respectively. Licensing and development
revenue for the three and six month periods was primarily from Teva
teriparatide and Pfizer rescue pen development programs.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalty revenue was
$5.6 million for the three months ended June 30, 2019 compared to
$1.3 million for the same period in 2018, a 335% increase.
For the six month period ended June 30, 2019, royalty revenue was
$9.6 million, compared to $1.8 million for the comparable period in
2018, a 451% increase. The significant increases in royalty
revenue for the three and six month periods were primarily
attributable to royalties recognized from AMAG on their net sales
of the Makena® subcutaneous auto injector and from Teva on their
net sales of Epinephrine Injection USP, which was launched in late
2018.
Operating expenses were $17.6 million for the
second quarter of 2019 compared to $11.1 million in the comparable
period of 2018. Total operating expenses for the six months
ended June 30, 2019 were $34.9 million as compared to $22.2 million
for the comparable period in 2018. The increase in operating
expenses for the three and six month periods of 2019 was primarily
attributable to additional sales and marketing expenses associated
with the launch of XYOSTED®.
Net loss was $2.2 million for the second quarter
of 2019, compared to $4.5 million in the comparable period in 2018,
and $7.8 million for the six months ended June 30, 2019 compared to
$10.7 million in the comparable period of 2018, a reduction of
28%. Net loss per share was $0.01 and $0.05 for the three and
six month periods ended June 30, 2019, respectively, and $0.03 and
$0.07 for the comparable periods in 2018, respectively.
At June 30, 2019, cash and cash equivalents were
$40.2 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 million upon execution of the agreement.
2019 Financial Guidance
The Company is raising full year 2019 revenue
guidance to a range of $100.0 million to $110.0 million, from a
previous range of $95.0 million to $105.0 million.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review second quarter 2019 financial results via webcast and
conference call today, August 6, 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
1-888-220-8451, or 1-323-794-2588. Callers should reference
the Antares Pharma conference call or conference identification
code 1360837. 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, August 6, 2019
through 11:30 a.m. ET on Thursday, September 5, 2019. To access the
replay, callers should dial 1-888-203-1112 or 1-719-457-0820 and
enter passcode 1360837.
About Antares Pharma
Antares Pharma, Inc. is a combination drug
device 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. 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; 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; successful completion of the
transaction with Ferring International Center, S.A.; continued
growth in product, development, licensing and royalty revenue;
achievement of the updated 2019 revenue guidance; the Company’s
ability to meet loan extension and interest only payment milestones
and the ability to repay the debt obligation with 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 |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
June 30, |
|
|
Increase |
|
2019 |
|
|
2018 |
|
|
(Decrease) |
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
$ |
20,620 |
|
|
$ |
11,095 |
|
|
86 |
% |
|
|
$ |
38,920 |
|
|
$ |
22,044 |
|
|
77 |
% |
Licensing and development revenue |
|
2,239 |
|
|
|
1,785 |
|
|
25 |
% |
|
|
|
3,154 |
|
|
|
3,070 |
|
|
3 |
% |
Royalties |
|
5,574 |
|
|
|
1,282 |
|
|
335 |
% |
|
|
|
9,645 |
|
|
|
1,751 |
|
|
451 |
% |
Total revenue |
|
28,433 |
|
|
|
14,162 |
|
|
101 |
% |
|
|
|
51,719 |
|
|
|
26,865 |
|
|
93 |
% |
Cost of Revenue |
|
12,441 |
|
|
|
6,960 |
|
|
79 |
% |
|
|
|
23,387 |
|
|
|
14,146 |
|
|
65 |
% |
Gross profit |
|
15,992 |
|
|
|
7,202 |
|
|
122 |
% |
|
|
|
28,332 |
|
|
|
12,719 |
|
|
123 |
% |
Research and development |
|
2,494 |
|
|
|
3,230 |
|
|
(23 |
)% |
|
|
|
4,881 |
|
|
|
6,130 |
|
|
(20 |
)% |
Selling, general and administrative |
|
15,087 |
|
|
|
7,883 |
|
|
91 |
% |
|
|
|
30,022 |
|
|
|
16,119 |
|
|
86 |
% |
Total operating expenses |
|
17,581 |
|
|
|
11,113 |
|
|
58 |
% |
|
|
|
34,903 |
|
|
|
22,249 |
|
|
57 |
% |
Operating loss |
|
(1,589 |
) |
|
|
(3,911 |
) |
|
(59 |
)% |
|
|
|
(6,571 |
) |
|
|
(9,530 |
) |
|
(31 |
)% |
Other expense |
|
(637 |
) |
|
|
(609 |
) |
|
5 |
% |
|
|
|
(1,194 |
) |
|
|
(1,183 |
) |
|
1 |
% |
Net loss |
$ |
(2,226 |
) |
|
$ |
(4,520 |
) |
|
(51 |
)% |
|
|
$ |
(7,765 |
) |
|
$ |
(10,713 |
) |
|
(28 |
)% |
Basic and diluted net loss per common share |
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
|
|
|
Basic and diluted weighted average common shares
outstanding |
|
162,734 |
|
|
|
157,024 |
|
|
|
|
|
|
|
161,596 |
|
|
|
156,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
Three Months Ended June 30, |
|
|
Six Months
Ended June 30, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
$ |
4,623 |
|
|
$ |
— |
|
|
$ |
5,326 |
|
|
$ |
— |
OTREXUP® |
|
4,361 |
|
|
|
3,755 |
|
|
|
8,429 |
|
|
|
7,726 |
Partnered product sales |
|
11,636 |
|
|
|
7,340 |
|
|
|
25,165 |
|
|
|
14,318 |
Total product sales |
$ |
20,620 |
|
|
$ |
11,095 |
|
|
$ |
38,920 |
|
|
$ |
22,044 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
June 30, |
|
|
December 31, |
|
2019 |
|
|
2018 |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
40,171 |
|
|
$ |
27,892 |
Accounts receivable |
|
24,629 |
|
|
|
18,976 |
Inventories |
|
15,235 |
|
|
|
11,350 |
Contract assets |
|
6,285 |
|
|
|
10,442 |
Equipment, molds, furniture and
fixtures, net |
|
14,994 |
|
|
|
14,895 |
Goodwill, intangibles and
right-of-use assets, net |
|
4,598 |
|
|
|
1,926 |
Other assets |
|
3,300 |
|
|
|
2,796 |
Total Assets |
$ |
109,212 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
Accounts payable and accrued
expenses |
$ |
24,270 |
|
|
$ |
23,132 |
Other current liabilities |
|
1,508 |
|
|
|
4,061 |
Long-term liabilities |
|
41,882 |
|
|
|
22,083 |
Stockholders’ equity |
|
41,552 |
|
|
|
39,001 |
Total Liabilities and Stockholders’ Equity |
$ |
109,212 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
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