Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”) today reported
operating and financial results for the third quarter ended
September 30, 2019. The Company reported revenue of $34.3 million
and earnings per share of $0.01 for the quarter ended September 30,
2019. The Company also reported record nine-month year-to-date
revenue of $86.0 million.
“I am extremely pleased to report another
quarter of record revenue driven by increased sales of our flagship
product XYOSTED, and strong demand for our partnered products, led
by the rapid growth of Teva’s generic EpiPen. Another historic
milestone for Antares today was the recognition of the first profit
from ongoing operations in the Company’s history.” said Robert F.
Apple, President and Chief Executive Officer of the Company. “While
our commercial organization is executing on the XYOSTED launch
plan, we continue to make progress on our strategy to drive
top-line revenue growth derived from a diverse mix of proprietary
and partnered product revenue. As a result of the growing demand
for our products and devices, we are once again revising upward our
full-year 2019 revenue guidance to a range of $115.0 to $120.0
million.”
Third Quarter 2019 and Recent
Highlights
- Reported third quarter 2019 revenue
of $34.3 million, an increase of 92% compared to the same period
last year. Generated third quarter product revenue of $24.7
million, an increase of 113% compared to the same period last year.
Third quarter royalty revenue was $8.4 million as compared to $3.7
million reported in the same period last year, a 126% increase.
Cash and cash equivalents were $41.9 million at September 30, 2019,
as compared to $40.2 million at June 30, 2019.
- Reported third quarter 2019
earnings per share of $0.01. This represents the Company’s first
quarterly income from ongoing operations.
- On October 28, 2019, we received
the final $2.5 million payment from Ferring Pharmaceuticals in
connection with the previously announced sale of the ZOMAJET™
needle-free delivery system. The gain on the sale of the needle
free product line was previously recorded in the fourth quarter of
2018.
- Announced two poster presentations
at the 20th Annual Fall Scientific Meeting of the Sexual Medicine
Society of America.
- Announced that our partner Teva
Pharmaceuticals launched a generic equivalent of the EpiPen Jr®.
Teva’s generic equivalent of the EpiPen® and the EpiPen Jr® utilize
the Antares Pharma VIBEX® device.
Third Quarter and Year-to-Date Financial
Results
Total revenue represents revenue generated from
product sales, development activities and royalties. Total revenue
was $34.3 million for the three months ended September 30, 2019,
compared to $17.9 million for the comparable period in 2018, a 92%
increase. For the nine months ended September 30, 2019, total
revenue was $86.0 million, compared to $44.7 million for the
comparable period in 2018, also a 92% increase.
Product sales represent sales of our proprietary
products and devices or device components to our partners. Product
sales were $24.7 million for the three months ended September 30,
2019, compared to $11.6 million for the comparable period in 2018,
a 113% increase. For the nine month period ended September 30,
2019, product sales were $63.6 million, compared to $33.6 million
for the comparable period in 2018, an 89% increase.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $11.5 million and $25.2 million for
the three and nine months ended September 30, 2019,
respectively, as compared to $4.1 million and $11.8 million for the
three and nine months ended September 30, 2018, respectively.
The increase in proprietary product sales for the three and nine
months ended September 30, 2019 as compared to the three and
nine months ended September 30, 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.
Partnered product sales were $13.2 million and $7.5 million for the
three months ended September 30, 2019 and 2018, respectively,
and $38.4 million and $21.8 million for the nine months ended
September 30, 2019 and 2018, respectively. The increase in sales of
partnered products for the three and nine months ended
September 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. With the final
Ferring payment received, we will no longer manufacture and supply
needle free devices.
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 $1.2 million and $4.4 million for the three
and nine month periods ended September 30, 2019, respectively,
compared to $2.6 million and $5.6 million for the comparable
periods in 2018, respectively. Licensing and development revenue
for the three and nine month periods was primarily from Teva
teriparatide pen and Pfizer rescue pen development programs.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalty revenue was $8.4
million for the three months ended September 30, 2019 compared to
$3.7 million for the same period in 2018, a 126% increase. For the
nine month period ended September 30, 2019, royalty revenue was
$18.1 million, compared to $5.5 million for the comparable period
in 2018, a 230% increase. The significant increases in royalty
revenue for the three and nine 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 $19.2 million for the
third quarter of 2019 compared to $11.9 million in the comparable
period of 2018. Total operating expenses for the nine months ended
September 30, 2019 were $54.2 million as compared to $34.2 million
for the comparable period in 2018. The increase in operating
expenses for the three and nine month periods of 2019 was primarily
attributable to additional sales and marketing expenses associated
with the launch of XYOSTED®.
Net income was $1.0 million for the third
quarter of 2019, compared to a ($1.9) million net loss in the
comparable period in 2018, and a ($6.7) million loss for the nine
months ended September 30, 2019 compared to ($12.6) million net
loss in the comparable period of 2018, a reduction of 47%. Net
income per share was $0.01 and net loss per share was ($0.04) for
the three and nine month periods ended September 30, 2019,
respectively, and net loss per share was ($0.01) and ($0.08) for
the comparable periods in 2018, respectively.
At September 30, 2019, cash and cash equivalents
were $41.9 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 $115.0 million to $120.0 million, from a
previous range of $100.0 million to $110.0 million.
Conference Call, Call Replay and
Webcast
Antares executives will provide a Company update
and review third quarter 2019 financial results via webcast and
conference call today, November 5, 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 1-888-204-4368,
or 1-323-994-2093. Callers should reference the Antares Pharma
conference call or conference identification code 8800570. 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, November 5, 2019 through 11:30 a.m. ET on
Thursday, December 5, 2019. To access the replay, callers should
dial 1-888-203-1112 or 1-719-457-0820 and enter passcode
8800570.
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;
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 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
revised revenue guidance; the Company’s ability to meet loan
extension and interest only payment milestones and the ability to
repay the debt obligation to Hercules Capital; successful
completion of the transaction with Ferring International Center,
S.A.; 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 |
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
September 30, |
|
|
Increase |
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
|
|
2019 |
|
|
2018 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
24,687 |
|
|
$ |
11,597 |
|
|
113% |
|
|
$ |
63,607 |
|
|
$ |
33,641 |
|
|
89% |
Licensing and development revenue |
|
|
1,211 |
|
|
|
2,554 |
|
|
(53)% |
|
|
|
4,365 |
|
|
|
5,624 |
|
|
(22)% |
Royalties |
|
|
8,408 |
|
|
|
3,717 |
|
|
126% |
|
|
|
18,053 |
|
|
|
5,468 |
|
|
230% |
Total revenue |
|
|
34,306 |
|
|
|
17,868 |
|
|
92% |
|
|
|
86,025 |
|
|
|
44,733 |
|
|
92% |
Cost of Revenue |
|
|
13,062 |
|
|
|
7,289 |
|
|
79% |
|
|
|
36,449 |
|
|
|
21,435 |
|
|
70% |
Gross profit |
|
|
21,244 |
|
|
|
10,579 |
|
|
101% |
|
|
|
49,576 |
|
|
|
23,298 |
|
|
113% |
Research and development |
|
|
2,863 |
|
|
|
3,191 |
|
|
(10)% |
|
|
|
7,744 |
|
|
|
9,321 |
|
|
(17)% |
Selling, general and administrative |
|
|
16,385 |
|
|
|
8,747 |
|
|
87% |
|
|
|
46,407 |
|
|
|
24,866 |
|
|
87% |
Total operating expenses |
|
|
19,248 |
|
|
|
11,938 |
|
|
61% |
|
|
|
54,151 |
|
|
|
34,187 |
|
|
58% |
Operating income (loss) |
|
|
1,996 |
|
|
|
(1,359 |
) |
|
(247)% |
|
|
|
(4,575 |
) |
|
|
(10,889 |
) |
|
(58)% |
Other expense |
|
|
(953 |
) |
|
|
(577 |
) |
|
65% |
|
|
|
(2,147 |
) |
|
|
(1,760 |
) |
|
22% |
Net income (loss) |
|
$ |
1,043 |
|
|
$ |
(1,936 |
) |
|
(154)% |
|
|
$ |
(6,722 |
) |
|
$ |
(12,649 |
) |
|
(47)% |
Basic and diluted net income (loss) per share |
|
$ |
0.01 |
|
|
$ |
(0.01 |
) |
|
|
|
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
163,119 |
|
|
|
157,471 |
|
|
|
|
|
|
162,109 |
|
|
|
157,076 |
|
|
|
Diluted |
|
|
168,503 |
|
|
|
157,471 |
|
|
|
|
|
|
162,109 |
|
|
|
157,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
7,020 |
|
|
$ |
— |
|
|
$ |
12,346 |
|
|
$ |
— |
OTREXUP® |
|
|
4,438 |
|
|
|
4,094 |
|
|
|
12,867 |
|
|
|
11,820 |
Partnered product sales |
|
|
13,229 |
|
|
|
7,503 |
|
|
|
38,394 |
|
|
|
21,821 |
Total product sales |
|
$ |
24,687 |
|
|
$ |
11,597 |
|
|
$ |
63,607 |
|
|
$ |
33,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
September 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
41,874 |
|
|
$ |
27,892 |
|
Accounts receivable |
|
33,931 |
|
|
|
18,976 |
|
Inventories |
|
16,503 |
|
|
|
11,350 |
|
Contract assets |
|
6,199 |
|
|
|
10,442 |
|
Equipment, molds, furniture and
fixtures, net |
|
15,409 |
|
|
|
14,895 |
|
Goodwill, intangibles and
right-of-use assets, net |
|
7,065 |
|
|
|
1,926 |
|
Other assets |
|
1,948 |
|
|
|
2,796 |
|
Total Assets |
$ |
122,929 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
$ |
31,496 |
|
|
$ |
23,132 |
|
Other current liabilities |
|
2,387 |
|
|
|
4,061 |
|
Long-term liabilities |
|
44,631 |
|
|
|
22,083 |
|
Stockholders’ equity |
|
44,415 |
|
|
|
39,001 |
|
Total Liabilities and Stockholders’ Equity |
$ |
122,929 |
|
|
$ |
88,277 |
|
|
|
|
|
|
|
|
|
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