Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty
pharmaceutical company, today reported financial and operating
results for the second quarter ended June 30, 2021 with record
revenue of $45.0 million and net income of $4.4 million, or $0.03
per basic and diluted earnings per share.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, commented, “We believe our strong second
quarter performance highlights the growth opportunities that
prevail across our diversified business. XYOSTED and Teva’s generic
EpiPen continue to be the primary drivers of our 39% year-over-year
revenue increase and we continue to expect our full year revenue
guidance to be in the range of $175-200 million. As we look ahead,
we expect the advancement of our proprietary pipeline as well as
our partner’s programs to support our future growth. With the
unveiling of ATRS-1902 as hydrocortisone with a new autoinjector
platform for adrenal crisis rescue, we are eager to initiate the PK
study following the FDA’s recent acceptance of our IND submission.
With our Quickshot autoinjector, we are also excited for our
partner Idorsia’s initiation of their global Phase 3 study for
selatogrel as a heart attack rescue pen as well as the potential
NDA filing of Pfizer’s undisclosed rescue pen in the second half of
2021. Overall, we believe the diversification of our business
remains foundational to our ongoing success.”
Second Quarter 2021 and Recent Highlights
- XYOSTED® total prescriptions in the
second quarter 2021 increased 50% year-over-year and 15%
sequentially from first quarter 2021, according to IQVIA.
- Teva’s generic EpiPen prescriptions
increased 153% year-over-year, contributing to a 47% increase in
EpiPen product and royalty revenue
- Submitted the IND and received FDA
acceptance for ATRS-1902 for adrenal crisis rescue
- Partner Idorsia Ltd initiating
global Phase 3 study with selatogrel for acute myocardial
infarction
- Completed $15.0 million principal
pre-payment of Hercules term loan and reduced associated interest
expense by $1.2 million annually
Second Quarter 2021 Financial
Results
Total revenue generated from product sales,
license and development activities and royalties was $45.0 million
for the three months ended June 30, 2021, a 39% increase compared
to $32.4 million in the same period in 2020. For the six months
ended June 30, 2021, total revenue was $87.1 million, a 33%
increase from $65.5 million for the comparable period in 2020.
Product sales were $27.9 million for the three
months ended June 30, 2021, a 13% increase compared to $24.7
million for the same period in 2020. For the six months ended June
30, 2021, product sales were $57.0 million, a 10% increase from
$51.8 million in the comparable period in 2020.
Sales of our proprietary products XYOSTED®,
OTREXUP® and NOCDURNA® generated revenue of $19.0 million and $37.7
million for the three and six months ended June 30, 2021,
respectively, as compared to $14.8 million and $27.4 million for
the three and six months ended June 30, 2020, respectively. The 28%
and 37% increase in proprietary product sales for the three and six
months ended June 30, 2021, respectively, compared to the same
periods in 2020 were principally attributable to continued growth
in prescriptions and sales of XYOSTED®.
Partnered product sales were $9.0 million and
$19.4 million for the three and six months ended June 30, 2021,
respectively, as compared to $9.8 million and $24.4 million for the
three and six months ended June 30, 2020, respectively. The net
decrease in sales of partnered products for the second quarter and
six months ended June 30, 2021 as compared to the same periods in
2020 is primarily attributable to a decrease in sales of
sumatriptan to Teva and Makena® autoinjectors to AMAG.
Licensing and development revenue was $7.2
million and $12.2 million for the three and six month ended June
30, 2021, respectively, as compared to $2.7 million and $4.4
million for the comparable periods in 2020, respectively. The
increase in licensing and development revenue for the three and six
months ended June 30, 2021 was primarily a result of incremental
development and maintenance activities with Teva and our other
ongoing partnered development projects.
Royalty revenue was $9.9 million for the three
months ended June 30, 2021 compared to $5.0 million for the same
period in 2020. For the six months ended June 30, 2021, royalty
revenue was $17.9 million, as compared to $9.3 million for the same
period in 2020. The net increase in royalty revenue in the three
and six months ended June 30, 2021 was attributable to an increase
in royalties from Teva on their net sales of generic EpiPen®.
Research and development expenses were $4.0
million and $6.7 million for the three and six months ended June
30, 2021, respectively, as compared to $2.4 million and $5.4
million for the comparable periods in 2020, respectively. The
increase in research and development costs incurred in 2021 as
compared to 2020 was attributable to our ongoing internal
development programs.
Selling, general and administrative expenses
were $17.7 million and $35.3 million for the three and six months
ended June 30, 2021, respectively, as compared to $14.4 million and
$30.9 million for the comparable periods in 2020, respectively. The
net increase in selling, general and administrative expenses for
the three and six months ended June 30, 2021 was primarily due to
an increase in sales and marketing expenses that had declined
during the pandemic and incremental costs associated with
NOCDURNA®. General and administrative expenses increased due to
increases in compensation and professional services.
Net income was $4.4 million, or $0.03 per basic
and diluted earnings per share for the second quarter 2021,
compared to $2.2 million, or $0.01 per basic and diluted earnings
per share in the same period in 2020. Net income was $8.2 million,
or $0.05 per basic and diluted earnings per share for the six
months ended June 30, 2021 compared to a net loss of $0.2 million,
or $0.00 loss per basic and diluted earnings per share in the
comparable period of 2020.
As of June 30, 2021, cash and cash equivalents
were $45.1 million compared to $53.1 million as of December 31,
2020. In June 2021, Antares made a $15.0 million principal
prepayment and reduced our loan balance with Hercules Capital to
$25.0 million. The Company generated cash from operations of $8.4
million for the six months ended June 30, 2021.
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.
Webcast and Conference Call
Information
The Antares management team will provide a
Company update and review the second quarter and year-to-date
financial results via conference call and webcast today, August 5,
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 (800) 367-2403 for domestic callers and
(334) 777-6978 for international callers. Callers should reference
the Antares Pharma conference call or conference ID number
3020992.
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,
clinical trials, 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; future prescriptions and sales of
OTREXUP®; successful
commercialization of NOCDURNA® in
the U.S. 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 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; Teva’s ability to
successfully commercialize generic teriparatide in Europe, Canada
and Israel and future revenue from the same, successful development
including the timing and results of the Phase 3 trial of the drug
device combination product for selatogrel with Idorsia
Pharmaceuticals and FDA and global regulatory approvals and future
revenue from the same; the timing and results of the clinical
development program for ATRS-1902 adrenal crisis rescue
auto-injector, future NDA submission and FDA approval of the same,
and if approved, future market acceptance and revenue for the same;
FDA approval of Teva’s ANDAs for both generic
Forteo® and
Byetta® 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 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 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(in thousands, except per share
amounts)(unaudited)
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
June 30, |
|
|
Increase |
|
|
2021 |
|
|
2020 |
|
|
(Decrease) |
|
2021 |
|
|
2020 |
|
|
(Decrease) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
27,904 |
|
|
$ |
24,665 |
|
|
13% |
|
$ |
57,039 |
|
|
$ |
51,762 |
|
|
10% |
Development and licensing revenue |
|
|
7,167 |
|
|
|
2,687 |
|
|
167% |
|
|
12,151 |
|
|
|
4,442 |
|
|
174% |
Royalties |
|
|
9,907 |
|
|
|
5,032 |
|
|
97% |
|
|
17,871 |
|
|
|
9,259 |
|
|
93% |
Total revenue |
|
|
44,978 |
|
|
|
32,384 |
|
|
39% |
|
|
87,061 |
|
|
|
65,463 |
|
|
33% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
11,630 |
|
|
|
10,927 |
|
|
6% |
|
|
24,128 |
|
|
|
24,941 |
|
|
(3)% |
Cost of development revenue |
|
|
4,810 |
|
|
|
1,550 |
|
|
210% |
|
|
8,757 |
|
|
|
2,583 |
|
|
239% |
Research and development |
|
|
4,047 |
|
|
|
2,417 |
|
|
67% |
|
|
6,687 |
|
|
|
5,398 |
|
|
24% |
Selling, general and administrative |
|
|
17,704 |
|
|
|
14,448 |
|
|
23% |
|
|
35,311 |
|
|
|
30,870 |
|
|
14% |
Total operating expenses |
|
|
38,191 |
|
|
|
29,342 |
|
|
30% |
|
|
74,883 |
|
|
|
63,792 |
|
|
17% |
Operating income |
|
|
6,787 |
|
|
|
3,042 |
|
|
123% |
|
|
12,178 |
|
|
|
1,671 |
|
|
629% |
Other expense |
|
|
(1,224 |
) |
|
|
(867 |
) |
|
41% |
|
|
(2,232 |
) |
|
|
(1,852 |
) |
|
21% |
Net income (loss) before income
taxes |
|
|
5,563 |
|
|
|
2,175 |
|
|
156% |
|
|
9,946 |
|
|
|
(181 |
) |
|
** |
Income tax expense |
|
|
(1,143 |
) |
|
|
— |
|
|
** |
|
|
(1,733 |
) |
|
|
— |
|
|
** |
Net income (loss) |
|
$ |
4,420 |
|
|
$ |
2,175 |
|
|
103% |
|
$ |
8,213 |
|
|
$ |
(181 |
) |
|
** |
Net income (loss) per common
share, basic |
|
$ |
0.03 |
|
|
$ |
0.01 |
|
|
|
|
|
$ |
0.05 |
|
|
$ |
(0.00 |
) |
|
|
|
Net income (loss) per common
share, diluted |
|
$ |
0.03 |
|
|
$ |
0.01 |
|
|
|
|
|
$ |
0.05 |
|
|
$ |
(0.00 |
) |
|
|
|
Weighted average common shares
outstanding, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
169,043 |
|
|
|
165,703 |
|
|
|
|
|
|
168,436 |
|
|
|
165,566 |
|
|
|
|
Diluted |
|
|
174,813 |
|
|
|
169,228 |
|
|
|
|
|
|
174,851 |
|
|
|
165,566 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED REVENUE
DETAILS(in
thousands)(unaudited)
|
|
Three Months Ended |
|
|
|
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
|
Increase |
|
June 30, |
|
|
Increase |
|
|
2021 |
|
|
2020 |
|
|
(Decrease) |
|
2021 |
|
|
2020 |
|
|
(Decrease) |
Proprietary product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
14,739 |
|
|
$ |
10,902 |
|
|
35% |
|
|
$ |
29,128 |
|
|
$ |
19,905 |
|
|
46% |
|
OTREXUP® |
|
|
3,426 |
|
|
|
3,944 |
|
|
(13)% |
|
|
|
6,994 |
|
|
|
7,507 |
|
|
(7)% |
|
NOCDURNA® |
|
|
788 |
|
|
|
— |
|
|
100% |
|
|
|
1,563 |
|
|
|
— |
|
|
100% |
|
Total proprietary product
sales |
|
|
18,953 |
|
|
|
14,846 |
|
|
28% |
|
|
|
37,685 |
|
|
|
27,412 |
|
|
37% |
|
Partnered product sales |
|
|
8,951 |
|
|
|
9,819 |
|
|
(9)% |
|
|
|
19,354 |
|
|
|
24,350 |
|
|
(21)% |
|
Total product sales |
|
|
27,904 |
|
|
|
24,665 |
|
|
13% |
|
|
|
57,039 |
|
|
|
51,762 |
|
|
10% |
|
Development and licensing
revenue |
|
|
7,167 |
|
|
|
2,687 |
|
|
167% |
|
|
|
12,151 |
|
|
|
4,442 |
|
|
174% |
|
Royalties |
|
|
9,907 |
|
|
|
5,032 |
|
|
97% |
|
|
|
17,871 |
|
|
|
9,259 |
|
|
93% |
|
Total revenue |
|
$ |
44,978 |
|
|
$ |
32,384 |
|
|
39% |
|
|
$ |
87,061 |
|
|
$ |
65,463 |
|
|
33% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(in
thousands)(unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
45,126 |
|
|
$ |
53,137 |
|
Accounts receivable |
|
|
54,224 |
|
|
|
42,221 |
|
Inventories |
|
|
18,644 |
|
|
|
18,216 |
|
Contract assets |
|
|
5,725 |
|
|
|
8,140 |
|
Prepaids and other current
assets |
|
|
4,244 |
|
|
|
4,877 |
|
Property and equipment, net |
|
|
25,590 |
|
|
|
24,020 |
|
Deferred tax assets |
|
|
45,249 |
|
|
|
46,982 |
|
Other assets |
|
|
13,817 |
|
|
|
14,938 |
|
Total Assets |
|
$ |
212,619 |
|
|
$ |
212,531 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
46,487 |
|
|
$ |
43,032 |
|
Long-term debt |
|
|
26,151 |
|
|
|
40,899 |
|
Other liabilities |
|
|
7,953 |
|
|
|
9,485 |
|
Stockholders’ equity |
|
|
132,028 |
|
|
|
119,115 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
212,619 |
|
|
$ |
212,531 |
|
|
|
|
|
|
|
|
|
|
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Sep 2023 to Sep 2024