Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty
pharmaceutical company, today reported financial and operating
results for the fourth quarter ended December 31, 2020 with record
revenue of $44.1 million and net income of $51.4 million, or basic
and diluted earnings per share of $0.31 and $0.30, respectively,
which included a net tax benefit of $46.3 million. The Company also
reported record full-year 2020 revenue of $149.6 million and net
income of $56.2 million, or basic and diluted earnings per share of
$0.34 and $0.33, respectively. The full year net income included
the above referenced net tax benefit of $46.3 million or $0.28 and
$0.27 per basic and diluted share, respectively, resulting from a
deferred tax asset valuation allowance reversal. (See Table 3 for
details of the components of net income and computation of per
share amounts.)
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, commented, “We are very proud of our
accomplishments this past year that contributed to record annual
revenue of $150 million. Despite ongoing challenges due to the
global COVID-19 pandemic, the diversification of our business with
our proprietary and partner revenue continues to bolster our
overall growth, profitability, and cash flow. Driven by strong
demand for XYOSTED, our proprietary revenue grew to $63 million in
2020. The reach of our commercial sales organization to urologists
and endocrinologists has continued to drive the success of XYOSTED
as well as support the expansion of our proprietary portfolio with
NOCDURNA. We look forward to further expanding our internal
pipeline as we advance our endocrinology and urology assets from
successful Pre-IND meetings with the FDA last year to IND
submissions this year. Our partner business also had another strong
year with total revenue of $87 million driven in large part to the
significant increases in market share of Teva’s generic
EpiPen.”
“As we look ahead, our full-year 2021 revenue
guidance of $175-200 million, which represents 17% to 34%
year-over-year growth, anticipates continued growth in XYOSTED as
well as our partner products. We also remain excited about the
potential FDA approval of Teva’s generic Forteo, ongoing progress
for Pfizer’s undisclosed asset, and the initiation of Idorsia’s
Phase III trial for their selatogrel rescue pen program that has
received fast-track designation by the FDA. Overall, the
diversification of our business has proven to be a strong
foundation from which we will continue to expand.”
Fourth Quarter 2020 and Recent Highlights
- XYOSTED® total prescriptions in the
fourth quarter 2020 increased 13% sequentially and 76%
year-over-year, according to IQVIA.
- Entered an exclusive license
agreement with Ferring Pharmaceuticals for NOCDURNA® in the U.S.
that expands our proprietary portfolio and leverages our commercial
organization.
- Recorded an income tax benefit of
$46.3 million for the fourth quarter and full-year 2020 resulting
primarily from the net valuation allowance release of $53.4 million
on deferred tax assets.
- Announced full-year 2021 revenue
guidance of $175-200 million, which represents a 17% to 34%
year-over-year growth rate and assumes a range of revenue scenarios
for the potential approval and launch of generic Forteo® by our
partner Teva in the U.S.
Fourth Quarter and Full-Year 2020
Financial Results
Total revenue generated from product sales,
license and development activities and royalties was $44.1 million
for the three months ended December 31, 2020, a 17% increase
compared to $37.8 million in the same period in 2019. For the full
year ended December 31, 2020, total revenue was $149.6 million, a
21% increase from $123.9 million for the comparable period in
2019.
Product sales were $33.1 million for the three
months ended December 31, 2020, a 16% increase compared to $28.5
million for the same period in 2019. For the twelve-month period
ended December 31, 2020, product sales were $113.8 million, a 24%
increase from $92.1 million in the comparable period in 2019.
Sales of our proprietary products XYOSTED®,
OTREXUP® and NOCDURNA® generated revenue of $19.7 million and $62.9
million for the three months and full-year ended December 31, 2020,
respectively, as compared to $14.0 million and $39.2 million for
the three months and full-year ended December 31, 2019,
respectively. The 41% and 60% increase in proprietary product sales
for the three-month and full-year ended December 31, 2020
respectively, compared to the three months and full-year ended
December 31, 2019 were principally attributable to continued growth
in prescriptions and sales of XYOSTED®.
Partnered product sales were $13.4 million and
$14.5 million for the three months ended December 31, 2020 and
2019, respectively, and $51.0 million and $52.9 million for the
full year ended December 31, 2020 and 2019, respectively. The net
decrease in sales of partnered products for the fourth quarter and
full-year ended December 31, 2020 as compared to the same periods
in 2019 is attributable to decreased sales of needle-free devices
to Ferring, a decrease in sales of Makena® auto injectors to AMAG
and a reduction in pre-launch quantities of generic teriparatide
devices sold to Teva in previous periods. These decreases were
offset by an increase in sales to Teva of their generic EpiPen
auto-injectors.
Licensing and development revenue was $5.7
million and $14.5 million for the three and twelve-month periods
ended December 31, 2020, respectively, as compared to $3.2 million
and $7.5 million for the comparable periods in 2019, respectively.
The increase in licensing and development revenue for the fourth
quarter and full year ended December 31, 2020 was primarily from
the Pfizer rescue pen and the Idorsia selatogrel pen development
programs.
Royalty revenue was $5.3 million for the three
months ended December 31, 2020 compared to $6.2 million for the
same period in 2019. For the twelve-month period ended December 31,
2020, royalty revenue was $21.3 million, as compared to $24.2
million for the same period in 2019. The net decrease in royalty
revenue was primarily attributable to a decline in royalties
recognized from AMAG on their net sales of the Makena® subcutaneous
auto injectors offset by an increase in royalties from Teva on
their net sales of generic EpiPen.
Research and development expenses were $2.3
million and $10.1 million for the three and twelve-month periods
ended December 31, 2020, respectively, as compared to $2.9 million
and $10.6 million for the comparable periods in 2019, respectively.
The decrease in research and development costs incurred in 2020 as
compared to 2019 was due to the timing of clinical studies for our
internal pipeline products.
Selling, general and administrative expenses
were $16.7 million and $62.8 million for the three and twelve-month
periods ended December 31, 2020, respectively, as compared to $15.4
million and $61.8 million for the comparable periods in 2019,
respectively. The net increase in selling, general and
administrative expenses for the three and twelve-month period ended
December 31, 2020 was primarily due to increases in payroll and
equity-based compensation costs and additional overhead costs of
our new facility, offset by reductions in sales and marketing costs
incurred as a result of the various stay at home orders and travel
restrictions related to the COVID-19 pandemic.
Antares recorded an income tax benefit of $46.3
million for the fourth quarter and full-year 2020 resulting
primarily from the net valuation allowance release of $53.4 million
on our deferred tax assets. As of December 31, 2020, management
concluded that as a result of generating pre-tax earnings,
utilization of net operating loss carryovers and future projected
pre-tax earnings, it is more likely than not that nearly all of our
deferred taxes are realizable and may be utilized to offset future
tax liabilities.
Including the tax benefit, net income was $51.4
million, or $0.31 and $0.30 per basic and diluted share,
respectively, for the fourth quarter of 2020, compared to $4.7
million, or $0.03 per basic and diluted share in the same period in
2019. Net income was $56.2 million, or $0.34 and $0.33 per basic
and diluted share, respectively, for the full year ended December
31, 2020 compared to a net loss of $2.0 million, or $0.01 loss per
basic and diluted share in the comparable period of 2019.
As of December 31, 2020, cash and cash
equivalents were $53.1 million compared to $45.7 million as of
December 31, 2019. Cash generated from operations was $21.3 million
for the full-year ended December 31, 2020, compared to cash used in
operations of $10.6 million for the full-year ended December 31,
2019.
Full-Year 2021 Financial
Guidance
The Company today reaffirmed full-year 2021
revenue guidance in the range of $175-200 million, which represents
a 17% to 34% year-over-year growth rate and assumes no significant
disruptions to supply or operations due to the ongoing COVID-19
pandemic and a range of revenue scenarios for the potential
approval and launch of generic Forteo® by our partner Teva in the
U.S.
Webcast and Conference Call
Information
The Antares management team will provide a
Company update and review the fourth quarter and full-year 2020
financial results via conference call and webcast today, March 2,
2021, at 8:30am ET (Eastern Time). The webcast of the conference
call will include a slide presentation, which can be accessed in
the investor relations 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 (888) 254-3590 for domestic callers and
(323) 994-2093 for international callers. Callers should reference
the Antares Pharma conference call or conference ID number
1389407.
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical 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
(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. The Company also markets NOCDURNA®
(desmopressin acetate) in the U.S., which was licensed from Ferring
Pharmaceuticals.
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 Company’s ability to achieve
the 2021 full-year revenue guidance; the uncertainty regarding the
ongoing COVID-19 pandemic, including new strains of the virus, 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; 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; successful commercialization of
NOCDURNA® in the United States
and market acceptance and future revenue from the same;
whether the FDA will withdraw marketing approval for AMAG
Pharmaceuticals’ Makena®
subcutaneous auto injector following the recent FDA letter
seeking withdrawal, whether AMAG will be granted an appeal hearing
and if granted, whether Makena®
will be successful and future
prescriptions, market acceptance and revenue from the same; Teva’s
ability to successfully commercialize
VIBEX® Sumatriptan Injection USP
and the amount of revenue from the same; future prescriptions and
sales of OTREXUP®; Teva’s ability
to successfully commercialize generic teriparatide in 11 countries
in Europe, Canada and Israel and future revenue from the same,
successful development including the timing and results of the
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; FDA approval
of Teva’s pending ANDA for generic
Forteo® and future revenue from
the same; the timing and results of the Company’s or its partners’
research projects or clinical trials of product candidates in
development including the Company’s endocrinology
and urology assets in development as well as
Pfizer’s undisclosed development product; 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:Tram BuiVice President,
Corporate Communications and Investor
Relations609-359-3016tbui@antarespharma.com
TABLES FOLLOW
ANTARES PHARMA,
INC.Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS(amounts in thousands except per share
amounts)(unaudited)
|
|
For the Quarter Ended |
|
|
|
|
|
|
For the Year Ended |
|
|
|
|
|
|
|
December 31, |
|
|
Increase |
|
|
December 31, |
|
|
Increase |
|
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
33,125 |
|
|
$ |
28,496 |
|
|
16 |
% |
|
|
$ |
113,834 |
|
|
$ |
92,103 |
|
|
24 |
% |
|
Development and licensing revenue |
|
|
5,703 |
|
|
|
3,164 |
|
|
80 |
% |
|
|
|
14,466 |
|
|
|
7,529 |
|
|
92 |
% |
|
Royalties |
|
|
5,305 |
|
|
|
6,179 |
|
|
(14 |
)% |
|
|
|
21,299 |
|
|
|
24,232 |
|
|
(12 |
)% |
|
Total revenue |
|
|
44,133 |
|
|
|
37,839 |
|
|
17 |
% |
|
|
|
149,599 |
|
|
|
123,864 |
|
|
21 |
% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
15,404 |
|
|
|
12,476 |
|
|
23 |
% |
|
|
|
53,960 |
|
|
|
46,267 |
|
|
17 |
% |
|
Cost of development revenue |
|
|
3,655 |
|
|
|
1,550 |
|
|
136 |
% |
|
|
|
9,140 |
|
|
|
4,208 |
|
|
117 |
% |
|
Research and development |
|
|
2,318 |
|
|
|
2,880 |
|
|
(20 |
)% |
|
|
|
10,121 |
|
|
|
10,624 |
|
|
(5 |
)% |
|
Selling, general and administrative |
|
|
16,658 |
|
|
|
15,366 |
|
|
8 |
% |
|
|
|
62,759 |
|
|
|
61,773 |
|
|
2 |
% |
|
Total operating expenses |
|
|
38,035 |
|
|
|
32,272 |
|
|
18 |
% |
|
|
|
135,980 |
|
|
|
122,872 |
|
|
11 |
% |
|
Operating income |
|
|
6,098 |
|
|
|
5,567 |
|
|
10 |
% |
|
|
|
13,619 |
|
|
|
992 |
|
|
1273 |
% |
|
Other expense |
|
|
(992 |
) |
|
|
(872 |
) |
|
14 |
% |
|
|
|
(3,698 |
) |
|
|
(3,019 |
) |
|
22 |
% |
|
Net income (loss) before income
taxes |
|
|
5,106 |
|
|
|
4,695 |
|
|
9 |
% |
|
|
|
9,921 |
|
|
|
(2,027 |
) |
|
** |
|
Income tax benefit |
|
|
46,280 |
|
|
|
— |
|
|
** |
|
|
|
46,280 |
|
|
|
— |
|
|
** |
|
Net income (loss) |
|
$ |
51,386 |
|
|
$ |
4,695 |
|
|
994 |
% |
|
|
$ |
56,201 |
|
|
$ |
(2,027 |
) |
|
** |
|
Net income (loss) per common
share, basic |
|
$ |
0.31 |
|
|
$ |
0.03 |
|
|
|
|
|
|
$ |
0.34 |
|
|
$ |
(0.01 |
) |
|
|
|
|
Net income (loss) per common
share, diluted |
|
$ |
0.30 |
|
|
$ |
0.03 |
|
|
|
|
|
|
$ |
0.33 |
|
|
$ |
(0.01 |
) |
|
|
|
|
Basic weighted average common
shares outstanding |
|
|
166,744 |
|
|
|
163,952 |
|
|
|
|
|
|
|
166,066 |
|
|
|
162,574 |
|
|
|
|
|
Diluted weighted average common
shares outstanding |
|
|
171,412 |
|
|
|
171,238 |
|
|
|
|
|
|
|
170,155 |
|
|
|
162,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAILS OF
REVENUE(amounts in
thousands)(unaudited)
|
|
Quarter Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Proprietary product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
14,399 |
|
|
$ |
8,423 |
|
|
$ |
46,549 |
|
|
$ |
20,769 |
|
OTREXUP® |
|
|
4,442 |
|
|
|
5,579 |
|
|
|
15,468 |
|
|
|
18,446 |
|
NOCDURNA® |
|
|
861 |
|
|
|
— |
|
|
|
861 |
|
|
|
— |
|
Total proprietary product
sales |
|
|
19,702 |
|
|
|
14,002 |
|
|
|
62,878 |
|
|
|
39,215 |
|
Partnered product sales |
|
|
13,423 |
|
|
|
14,494 |
|
|
|
50,956 |
|
|
|
52,888 |
|
Total product sales |
|
|
33,125 |
|
|
|
28,496 |
|
|
|
113,834 |
|
|
|
92,103 |
|
Development revenue |
|
|
5,703 |
|
|
|
3,164 |
|
|
|
14,466 |
|
|
|
7,529 |
|
Royalties |
|
|
5,305 |
|
|
|
6,179 |
|
|
|
21,299 |
|
|
|
24,232 |
|
Total revenue |
|
$ |
44,133 |
|
|
$ |
37,839 |
|
|
$ |
149,599 |
|
|
$ |
123,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 – COMPONENTS OF NET INCOME (LOSS) AND
COMPUTATION OF PER SHARE AMOUNTS(amounts in
thousands)(unaudited)
|
|
Quarter Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Net income (loss) before income
taxes |
|
$ |
5,106 |
|
|
$ |
4,695 |
|
|
$ |
9,921 |
|
|
$ |
(2,027 |
) |
Pre-tax earnings (loss) per share, basic and diluted |
|
$ |
0.03 |
|
|
$ |
0.03 |
|
|
$ |
0.06 |
|
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
$ |
46,280 |
|
|
$ |
— |
|
|
$ |
46,280 |
|
|
$ |
— |
|
Tax benefit per common share, basic |
|
$ |
0.28 |
|
|
$ |
— |
|
|
$ |
0.28 |
|
|
$ |
— |
|
Tax benefit per common share, diluted |
|
$ |
0.27 |
|
|
$ |
— |
|
|
$ |
0.27 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
51,386 |
|
|
$ |
4,695 |
|
|
$ |
56,201 |
|
|
$ |
(2,027 |
) |
Net income (loss) per common
share, basic |
|
$ |
0.31 |
|
|
$ |
0.03 |
|
|
$ |
0.34 |
|
|
$ |
(0.01 |
) |
Net income (loss) per common
share, diluted |
|
$ |
0.30 |
|
|
$ |
0.03 |
|
|
$ |
0.33 |
|
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common
shares outstanding |
|
|
166,744 |
|
|
|
163,952 |
|
|
|
166,066 |
|
|
|
162,574 |
|
Diluted weighted average common
shares outstanding |
|
|
171,412 |
|
|
|
171,238 |
|
|
|
170,155 |
|
|
|
162,574 |
|
ANTARES PHARMA,
INC.Table 4 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
53,137 |
|
|
$ |
45,721 |
|
Accounts receivable |
|
|
42,221 |
|
|
|
35,074 |
|
Inventories |
|
|
18,216 |
|
|
|
16,000 |
|
Property and equipment |
|
|
24,020 |
|
|
|
15,961 |
|
Deferred tax assets |
|
|
46,982 |
|
|
|
— |
|
Goodwill and intangibles |
|
|
8,788 |
|
|
|
1,573 |
|
Other assets |
|
|
19,167 |
|
|
|
18,422 |
|
Total Assets |
|
$ |
212,531 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
41,829 |
|
|
$ |
29,428 |
|
Long-term debt |
|
|
40,899 |
|
|
|
40,395 |
|
Other liabilities |
|
|
10,688 |
|
|
|
8,428 |
|
Stockholders’ equity |
|
|
119,115 |
|
|
|
54,500 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
212,531 |
|
|
$ |
132,751 |
|
Antares Pharma (NASDAQ:ATRS)
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From Apr 2024 to May 2024
Antares Pharma (NASDAQ:ATRS)
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From May 2023 to May 2024