Record Annual Revenue of $63.6 Million, a
17% Increase Over 2017 Revenue
Antares Pharma, Inc. (NASDAQ: ATRS) today reported unaudited
consolidated financial results and operational highlights for the
fourth quarter and full year ended December 31, 2018. The
Company reported total revenue of $18.8 million for the fourth
quarter of 2018 and $63.6 million for the year ended December 31,
2018. Net income per share was $0.04 for the fourth quarter
of 2018 and a net loss per share of $0.04 for the year ended
December 31, 2018, both of which were positively impacted by a
$12.5 million gain recognized in connection with the previously
disclosed sale of our needle free product line to Ferring
Pharmaceuticals.
“Antares achieved several significant and
transformational milestones last year which drove record
revenue. We obtained three product approvals utilizing our
device platform for our own product and our partners Teva and AMAG,
and we announced a new rescue pen development collaboration with
Pfizer. This is the fifth consecutive year of solid revenue
growth driven by our expanding and diversified portfolio of
proprietary and partnered products,” said Robert F. Apple,
President and Chief Executive Officer of the Company.
“Looking at 2019, our focus remains on the successful launch of
XYOSTED, our once-weekly subcutaneous auto injector product for
testosterone deficiency and the continued growth of our diverse
commercial business. On the development front, we remain
actively involved with Teva on the teriparatide ANDA and have begun
manufacturing devices for a potential launch of this product in the
second half of 2019, pending FDA approval. We believe Antares
has made significant progress both internally and through
partnerships toward achieving our goal of being recognized as a
leading combination drug device company.”
Fourth Quarter 2018 and Recent
Highlights
- Reported quarterly revenue of $18.8 million and annual revenue
of $63.6 million for the fourth quarter and year ended December 31,
2018. Reported cash and cash equivalents of $27.9 million at
December 31, 2018.
- Announced U.S. Food and Drug Administration (“FDA”) approval of
XYOSTED™ (testosterone enanthate) injection for testosterone
replacement therapy in adult males for conditions associated with a
deficiency or absence of endogenous testosterone. XYOSTED™
was made commercially available in late November 2018 with the
sales team commencing detailing to target physicians in
mid-December 2018.
- Announced that our partner Teva Pharmaceutical Industries,
Ltd.’s (“Teva”) commercially launched their generic EpiPen® in
limited quantities. The product was approved by the FDA and
deemed therapeutically equivalent and fully substitutable at the
pharmacy to the EpiPen®.
- Recorded the remaining gain on the 2017 sale of our needle free
product line to Ferring Pharmaceuticals of $12.5 million in the
fourth quarter of 2018.
- Appointed Peter S. Greenleaf to the Antares Board of
Directors. Mr. Greenleaf has over 20 years of pharmaceutical
experience and currently serves as the Chief Executive Officer of
Cerecor Inc. (NASDAQ: CERC). He is also Chairman of the Board
at BioDelivery Sciences (NASDAQ: BDSI).
Fourth Quarter and Year End 2018
Financial Results
Total revenue represents revenue generated from
product sales, licensing and development revenue and
royalties. Total revenue was $18.8 million for the three
months ended December 31, 2018, compared to $14.0 million for the
comparable period in 2017, a 34% increase. For the year ended
December 31, 2018, total revenue was $63.6 million, compared to
$54.5 million for the year ended December 31, 2017, a 17%
increase.
Product sales represent sales of our proprietary
products and devices or device components to our partners.
Product sales were $14.2 million for the three months ended
December 31, 2018, compared to $11.0 million for the comparable
period in 2017, a 30% increase and were $47.9 million for the year
ended December 31, 2018 compared to $41.7 million in the same
period of 2017, a 15% increase. The increase in product
revenue for the three month period was primarily attributable to
sales of Makena® auto injectors to AMAG, sumatriptan injection and
XYOSTED™ offset by a decrease in orders by Ferring for needle free
devices. The increase in product sales for the year was primarily
driven by sales of Makena® auto injectors to AMAG offset by
decreases in pre-launch generic epinephrine auto injector devices,
sumatriptan, and OTREXUP®.
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 $1.1 million and $2.2 million for the three
months ended December 31, 2018 and 2017, respectively, and $6.8
million and $11.2 million for the year ended December 31, 2018 and
2017, respectively. The decrease in licensing and development
revenue for both the three month period and year was primarily the
result of a reduction in development activities with AMAG for the
Makena® subcutaneous auto injector product, which was approved by
the FDA in February 2018 and is now a marketed product.
Royalties are recognized based on in-market
sales of products sold by our partners. Royalties were $3.5
million for the three months ended December 31, 2018 compared to
$0.8 million for the same period in 2017, and were $8.9 million for
the year ended December 31, 2018 compared to $1.6 million for
2017. The significant increase in royalties for both the
three month period and year was attributable to the launch of
AMAG’s Makena® auto injector product.
Total operating expenses were $14.9 million for
the three months ended December 31, 2018 compared to $11.0 million
in the comparable period of 2017. Total operating expenses
for the year ended December 31, 2018 were $49.1 million as compared
to $43.5 million for the same period in 2017. The increase in
operating expenses for the three and twelve month periods of 2018
was primarily due to increased compensation expense, sales,
marketing and administrative expenses associated with the approval
and launch of XYOSTED™.
Net income was $6.1 million for the fourth
quarter of 2018, compared to a loss of $3.7 million in the same
period in 2017, and a net loss of $6.5 million for the twelve
months ended December 31, 2018 compared to $16.7 million in the
same period of 2017. In the fourth quarter of 2018, we
recognized a $12.5 million gain in connection with the sale of our
needle free product line to Ferring Pharmaceuticals, resulting in
net income per share of $0.04 for the fourth quarter of 2018,
compared to net loss per share of $0.02 for the same period in
2017. Net loss per share was $0.04 for the year ended
December 31, 2018 compared to $0.11 for 2017.
At December 31, 2018, cash, cash equivalents and
investments were $27.9 million compared to $31.6 million at
December 31, 2017. During the fourth quarter of 2018, we generated
$7.5 million in gross proceeds from the sale of common stock at an
average price of $3.53 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 fourth quarter 2018 financial results via webcast and
conference call today, February 28, 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
1-855-719-5012, or 1-334-323-0522. Callers should reference
the Antares Pharma conference call or conference identification
code 7685531. 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, February 28, 2019
through 11:30 a.m. ET on Saturday, March 30, 2019. To access the
replay, callers should dial 1-888-203-1112 or 1-719-457-0820 and
enter passcode 7685531.
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;; 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®; successful completion of the transaction with
Ferring International Center, S.A.; 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; actions by the FDA or other regulatory agencies with
respect to the Company’s products or product candidates of its
partners; achievement of the 2019 total revenue guidance; continued
growth in product, development, licensing and royalty revenue; 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.
Contacts:
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)
|
For the Three Months Ended |
|
|
|
|
For the Year Ended |
|
|
|
|
December 31, |
|
|
Increase |
|
December 31, |
|
|
Increase |
|
2018 |
|
|
2017 |
|
|
(Decrease) |
|
2018 |
|
|
2017 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
$ |
14,229 |
|
|
$ |
10,987 |
|
|
30% |
|
$ |
47,870 |
|
|
$ |
41,695 |
|
|
15% |
Licensing
and development revenue |
|
1,129 |
|
|
|
2,219 |
|
|
(49)% |
|
|
6,753 |
|
|
|
11,171 |
|
|
(40)% |
Royalties |
|
3,463 |
|
|
|
834 |
|
|
315% |
|
|
8,931 |
|
|
|
1,649 |
|
|
442% |
Total
revenue |
|
18,821 |
|
|
|
14,040 |
|
|
34% |
|
|
63,554 |
|
|
|
54,515 |
|
|
17% |
Cost of revenue |
|
9,630 |
|
|
|
7,107 |
|
|
36% |
|
|
31,065 |
|
|
|
27,466 |
|
|
13% |
Gross
profit |
|
9,191 |
|
|
|
6,933 |
|
|
33% |
|
|
32,489 |
|
|
|
27,049 |
|
|
20% |
Research and
development |
|
3,673 |
|
|
|
3,612 |
|
|
2% |
|
|
14,254 |
|
|
|
13,147 |
|
|
8% |
Selling, general and
administrative |
|
11,230 |
|
|
|
7,340 |
|
|
53% |
|
|
34,836 |
|
|
|
30,353 |
|
|
15% |
Total
operating expenses |
|
14,903 |
|
|
|
10,952 |
|
|
36% |
|
|
49,090 |
|
|
|
43,500 |
|
|
13% |
Gain on sale of
assets |
|
12,500 |
|
|
|
860 |
|
|
1353% |
|
|
12,500 |
|
|
|
860 |
|
|
1353% |
Operating income
(loss) |
|
6,788 |
|
|
|
(3,159 |
) |
|
** |
|
|
(4,101 |
) |
|
|
(15,591 |
) |
|
(74)% |
Other expense |
|
(654 |
) |
|
|
(555 |
) |
|
18% |
|
|
(2,414 |
) |
|
|
(1,152 |
) |
|
110% |
Net income (loss) |
$ |
6,134 |
|
|
$ |
(3,714 |
) |
|
|
|
$ |
(6,515 |
) |
|
$ |
(16,743 |
) |
|
|
Net income (loss) per
common share, basic and diluted |
$ |
0.04 |
|
|
$ |
(0.02 |
) |
|
|
|
$ |
(0.04 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
December 31, |
|
December 31, |
|
2018 |
|
2017 |
Assets |
|
|
|
|
|
Cash, cash equivalents and
investments |
$ |
27,892 |
|
$ |
31,555 |
Accounts receivable |
|
18,976 |
|
|
11,878 |
Inventories |
|
11,350 |
|
|
9,275 |
Contract assets |
|
10,442 |
|
|
505 |
Equipment, molds,
furniture and fixtures, net |
|
14,895 |
|
|
16,158 |
Goodwill and
intangibles |
|
1,926 |
|
|
2,496 |
Other assets |
|
2,796 |
|
|
2,471 |
Total
Assets |
$ |
88,277 |
|
$ |
74,338 |
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
Accounts payable and
accrued expenses |
$ |
23,132 |
|
$ |
12,939 |
Deferred revenue |
|
1,018 |
|
|
2,994 |
Long-term debt |
|
25,126 |
|
|
24,858 |
Stockholders’ equity |
|
39,001 |
|
|
33,547 |
Total
Liabilities and Stockholders’ Equity |
$ |
88,277 |
|
$ |
74,338 |
|
|
|
|
|
|
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