Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a
pharmaceutical technology company, today reported financial and
operating results for the third quarter ended September 30, 2020
with record revenue of $40.0 million and net income of $5.0
million, or earnings per share of $0.03. The Company also reported
record nine-month year-to-date revenue of $105.5 million, a 23%
increase versus the first nine months of 2019.
“We are excited to report another quarter of
strong financial results that illustrate the significant growth
across our diversified business of both proprietary and partner
revenue. Our total revenue increased almost 17% year-over-year to
$40.0 million, primarily driven by strong demand for XYOSTED and
Teva’s generic Epipen. XYOSTED continues to represent our biggest
growth driver, with 129% quarterly growth and 237% year-to-date
growth in total prescriptions compared to the same periods in 2019.
We believe the ongoing challenges for patients and physicians due
to the pandemic will further support the increased demand for an
easy-to-use, painless at-home testosterone replacement therapy.
While we also remain committed to the development of our internal
pipeline focused on urology and endocrinology, we are excited about
the recent U.S. licensing of NOCDURNA which immediately expands our
proprietary portfolio offering and leverages our existing
salesforce given the significant overlap in urology call points,”
said Robert F. Apple, President and Chief Executive Officer of
Antares Pharma.
“Furthermore, we have a development pipeline
with our partners that we believe are underappreciated
opportunities. As generic teriparatide is launched in 11 European
countries, Canada and Israel by Teva, we remain eager for the
potential U.S approval. We also look forward to Idorsia initiating
their Phase 3 trial for the selatogrel pen and being able to
provide a timeline for the Pfizer program as we look ahead.
Overall, we believe our diversified business will continue to
advance and support our future aggressive growth,” Mr. Apple
concluded.
Third Quarter
2020 and Recent
Highlights
- Reported third
quarter 2020 total revenue of $40.0 million, an increase of 17%
compared to $34.3 million in the same period last year.
Proprietary product revenue increased 38% to $15.8 million compared
to $11.5 million in the third quarter of 2019. Total partnered
product, development and royalty revenue was $24.2 million for the
third quarter 2020 compared to $22.8 million in the third quarter
2019, representing an increase of 6%.
- Reported third quarter 2020 net
income of $5.0 million, or earnings per share of $0.03 compared to
net income of $1.0 million, or earnings per share of $0.01 in the
comparable period last year.
- XYOSTED® total prescriptions in the
third quarter 2020 increased 15% sequentially and 129%
year-over-year, according to IQVIA.
- Entered into an exclusive license
agreement with Ferring Pharmaceuticals for the marketed urology
product NOCDURNA® (desmopressin acetate), which is indicated for
the treatment of nocturia due to nocturnal polyuria in adults who
awaken at least two times per night to urinate, in the United
States.
Third Quarter
2020 Financial Results
Total revenue generated from product sales,
license and development activities and royalties was $40.0 million
for the three months ended September 30, 2020, a 17% increase
compared to $34.3 million in the same period in 2019. For the nine
months ended September 30, 2020, total revenue was $105.5 million,
a 23% increase from $86.0 million for the comparable period in
2019.
Product sales were $28.9 million for the three
months ended September 30, 2020, a 17% increase compared to $24.7
million for the same period in 2019. For the nine-month period
ended September 30, 2020, product sales were $80.7 million, a 27%
increase from $63.6 million in the comparable period in 2019.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $15.8 million and $43.2 million for
the three and nine months ended September 30, 2020,
respectively, as compared to $11.5 million and $25.2 million for
the three and nine months ended September 30, 2019,
respectively. The 38% and 71% increase in proprietary product sales
for the three and nine months ended September 30, 2020
respectively, compared to the three and nine months ended
September 30, 2019 were principally attributable to continued
growth in prescriptions and sales of XYOSTED®.
Partnered product sales were $13.2 million for
both the three months ended September 30, 2020 and 2019, and
$37.5 million and $38.4 million for the nine months ended September
30, 2020 and 2019, respectively. The net decrease in sales of
partnered products for the nine months ended September 30,
2020 as compared to the same period 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 $4.3
million and $8.8 million for the three and nine-month periods ended
September 30, 2020, respectively, as compared to $1.2 million and
$4.4 million for the comparable periods in 2019, respectively. The
increase in licensing and development revenue for the nine months
ended September 30, 2020 was primarily from the Pfizer rescue pen
and the Idorsia selatogrel pen development programs.
Royalty revenue was $6.7 million for the three
months ended September 30, 2020 compared to $8.4 million for the
same period in 2019. For the nine-month period ended September 30,
2020, royalty revenue was $16.0 million, as compared to $18.1
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 Epinephrine Injection USP.
Gross profit was $23.5 million and $21.2 million
for the three months ended September 30, 2020 and 2019,
respectively, and $61.4 million and $49.6 million for the nine
months ended September 30, 2020 and 2019, respectively. The
increase in gross profit was primarily attributable to the increase
in proprietary product sales.
Total operating expenses were $17.6 million for
the third quarter of 2020 compared to $19.2 million in the
comparable period of 2019. Total operating expenses for the nine
months ended September 30, 2020 were $53.9 million as compared to
$54.2 million for the comparable period in 2019. The decrease in
operating expenses for the three and nine-month periods of 2020 as
compared to the same periods in 2019 was primarily attributable to
a reduction in sales and marketing costs incurred as a result of
the various stay-at-home orders and travel restrictions related to
COVID-19.
Net income was $5.0 million, or $0.03 per share
for the third quarter of 2020, compared to $1.0 million, or $0.01
per share in the same period in 2019. Net income was $4.8 million,
or $0.03 per share for the nine months ended September 30, 2020
compared to a net loss of $6.7 million, or $0.04 loss per share in
the comparable period of 2019.
As of September 30, 2020, cash, cash equivalents
and short-term investments were $52.2 million compared to $45.7
million as of December 31, 2019. Cash generated from operations was
$14.2 million for the nine months ended September 30, 2020,
compared to cash used in operations of $9.5 million for the nine
months ended September 30, 2019.
Full-Year
2020 Financial
Guidance
The Company today reaffirmed full-year 2020
revenue guidance in the range of $135 to $155 million, which
represents a 9% to 25% year-over-year growth rate.
Webcast and Conference
Call Information
The Antares management team will provide a
Company update and review third quarter 2020 financial results via
conference call and webcast today, November 5, 2020, 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) 204-4368 for domestic callers and (323) 994-2093 for
international callers. Callers should reference the Antares Pharma
conference call or conference ID number 6925216.
About Antares Pharma
Antares Pharma, Inc. is a pharmaceutical
technology 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, Inc.
(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 reinstated 2020 full-year revenue guidance;
the uncertainty regarding the duration, scope and severity
of the COVID-19 pandemic 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;
successful commercialization of NOCDURNA®
in the United States and market acceptance and future
revenue from the same: 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; whether the FDA will
withdraw marketing approval for
AMAG’s Makena® subcutaneous auto
injector following the recent FDA letter seeking
withdrawal, whether AMAG will be granted an appeal hearing and if
granted, whether AMAG 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 clinical
bridging and 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 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 TO
FOLLOWANTARES 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 |
|
| |
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
| Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
28,947 |
|
|
$ |
24,687 |
|
|
17 |
% |
|
|
$ |
80,709 |
|
|
$ |
63,607 |
|
|
27 |
% |
|
|
Licensing and development revenue |
|
|
4,321 |
|
|
|
1,211 |
|
|
257 |
% |
|
|
|
8,763 |
|
|
|
4,365 |
|
|
101 |
% |
|
|
Royalties |
|
|
6,735 |
|
|
|
8,408 |
|
|
(20 |
)% |
|
|
|
15,994 |
|
|
|
18,053 |
|
|
(11 |
)% |
|
|
Total revenue |
|
|
40,003 |
|
|
|
34,306 |
|
|
17 |
% |
|
|
|
105,466 |
|
|
|
86,025 |
|
|
23 |
% |
|
| Cost of Revenue |
|
|
16,517 |
|
|
|
13,062 |
|
|
26 |
% |
|
|
|
44,041 |
|
|
|
36,449 |
|
|
21 |
% |
|
|
Gross profit |
|
|
23,486 |
|
|
|
21,244 |
|
|
11 |
% |
|
|
|
61,425 |
|
|
|
49,576 |
|
|
24 |
% |
|
| Research and development |
|
|
2,405 |
|
|
|
2,863 |
|
|
(16 |
)% |
|
|
|
7,803 |
|
|
|
7,744 |
|
|
1 |
% |
|
| Selling, general and
administrative |
|
|
15,231 |
|
|
|
16,385 |
|
|
(7 |
)% |
|
|
|
46,101 |
|
|
|
46,407 |
|
|
(1 |
)% |
|
|
Total operating expenses |
|
|
17,636 |
|
|
|
19,248 |
|
|
(8 |
)% |
|
|
|
53,904 |
|
|
|
54,151 |
|
|
0 |
% |
|
| Operating income (loss) |
|
|
5,850 |
|
|
|
1,996 |
|
|
193 |
% |
|
|
|
7,521 |
|
|
|
(4,575 |
) |
|
** |
|
| Other expense |
|
|
(854 |
) |
|
|
(953 |
) |
|
(10 |
)% |
|
|
|
(2,706 |
) |
|
|
(2,147 |
) |
|
26 |
% |
|
| Net income (loss) |
|
$ |
4,996 |
|
|
$ |
1,043 |
|
|
379 |
% |
|
|
$ |
4,815 |
|
|
$ |
(6,722 |
) |
|
** |
|
| Net income (loss) per common
share, basic and diluted |
|
$ |
0.03 |
|
|
$ |
0.01 |
|
|
|
|
|
|
$ |
0.03 |
|
|
$ |
(0.04 |
) |
|
|
|
|
| Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
166,375 |
|
|
|
163,119 |
|
|
|
|
|
|
|
165,838 |
|
|
|
162,109 |
|
|
|
|
|
|
Diluted |
|
|
169,655 |
|
|
|
168,503 |
|
|
|
|
|
|
|
169,759 |
|
|
|
162,109 |
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
|
September 30, |
|
|
September 30, |
|
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
| Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
12,245 |
|
|
$ |
7,020 |
|
|
$ |
32,150 |
|
|
$ |
12,346 |
|
|
OTREXUP® |
|
|
3,520 |
|
|
|
4,438 |
|
|
|
11,027 |
|
|
|
12,867 |
|
|
Partnered product sales |
|
|
13,182 |
|
|
|
13,229 |
|
|
|
37,532 |
|
|
|
38,394 |
|
|
Total product sales |
|
$ |
28,947 |
|
|
$ |
24,687 |
|
|
$ |
80,709 |
|
|
$ |
63,607 |
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
| |
|
September 30, |
|
|
December 31, |
|
| |
|
2020 |
|
|
2019 |
|
|
Assets |
|
|
|
|
|
|
|
|
| Cash, cash equivalents and
investments |
|
$ |
52,169 |
|
|
$ |
45,721 |
|
| Accounts receivable |
|
|
42,507 |
|
|
|
35,074 |
|
| Inventories |
|
|
19,809 |
|
|
|
16,000 |
|
| Contract assets |
|
|
8,784 |
|
|
|
8,235 |
|
| Property and equipment, net |
|
|
22,547 |
|
|
|
15,961 |
|
| Other assets |
|
|
9,758 |
|
|
|
11,760 |
|
|
Total Assets |
|
$ |
155,574 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
| Accounts payable and accrued
expenses |
|
$ |
40,862 |
|
|
$ |
30,677 |
|
| Deferred revenue |
|
|
3,277 |
|
|
|
1,738 |
|
| Long-term debt and other
liabilities |
|
|
46,194 |
|
|
|
45,836 |
|
| Stockholders’ equity |
|
|
65,241 |
|
|
|
54,500 |
|
|
Total Liabilities and Stockholders’ Equity |
|
$ |
155,574 |
|
|
$ |
132,751 |
|
| |
|
|
|
|
|
|
|
|
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