Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a
specialty pharmaceutical company developing medicines to treat
addictions and drug overdose, today reported financial results for
the three and six months ended June 30, 2021, and provided a
corporate update. Recent highlights include:
Pipeline and Corporate Update:
OPNT003, nasal nalmefene, for opioid
overdose:
- Completed confirmatory pharmacokinetic (“PK”) study; data
demonstrate rapid absorption and higher plasma concentrations
versus a nalmefene intramuscular injection (p<0.0001)
- Data from Pharmacodynamic (“PD”) anticipated later in the
fourth quarter
- Increasing need for OPNT003, with the Center for Disease
Control released provisional overdose death data
(predicted) for the full year 2020:
- 69,710 overdoses were caused by opioids, up 30% vs 2019, the
highest annual increase in three decades
- 57,550 opioid overdose deaths, or approximately 82%, were due
to illicit synthetic opioids, including fentanyl
OPNT004, drinabant, for Acute Cannabinoid
Overdose: Preclinical activities and formulation
development on track to support a Phase 1 study with parenteral
drinabant in 2022
OPNT002, nasal naltrexone, for Alcohol Use
Disorder: Start of Phase 2 study remains on pause; Company
continues to assess optimal time to proceed
Appointed Matthew Ruth as Chief Commercial Officer on
July 12; Mr. Ruth led the launch and
commercialization of the first FDA-approved nasal naloxone spray to
treat opioid overdose
Appointed Brian Gorman to Executive Vice President,
Corporate Development and General Counsel; Mr. Gorman was
promoted from General Counsel
Financial Highlights
Q2 revenues of $11.3 million, a 79% increase
over the same period in 2020, driven by NARCAN® Nasal Spray
(“NARCAN®”) royalties
$48.5 million in cash, cash equivalents and
marketable securities (as of June 30, 2021)
Raises full-year 2021 royalty revenue guidance
from the sale of NARCAN® Nasal Spray to approximately $28.9 million
and raises full year 2021 cash, cash equivalents and
marketable securities guidance in the range of
approximately $42 million to $44 million excluding any additional
tranches from the convertible debt deal
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“We continue to achieve significant pipeline progress, having
recently announced positive confirmatory PK data for OPNT003, nasal
nalmefene, which we believe provides strong support for its
continued development as a potential new standard of care in the
treatment of opioid overdose. We are now focused on the PD study
and our preparations for NDA submission, expected to occur at year
end or in the first quarter of 2022. This program has never been
more relevant as opioid overdose deaths increase. The U.S.
experienced its deadliest year in 2020 driven by potent synthetic
opioids such as fentanyl. Our goal is to provide the first
responders, healthcare providers and communities responding to
these highly potent, yet treatable, overdoses with a much needed
new rescue agent option as quickly as possible.”
“With the addition of Matt and our promotion of Brian, we are
fortunate to have such experienced leaders to support us in
delivering on the promise of our pipeline and advancing our mission
to create best-in-class medicines for the treatment of addictions
and drug overdose.”
David O’Toole, Chief Financial Officer of Opiant, said:
“Increased demand for NARCAN® in the current quarter meant we
recognized significantly higher than expected royalties this
quarter. Looking forward through the end of the year, we remain
confident in our ability to achieve or even exceed our updated
royalty revenue guidance and ending cash target in 2021, while we
continue to focus on delivering a potentially breakthrough new
treatment to confront the escalating opioid overdose crisis.”
Financial Results for the Three Months Ended June 30,
2021
For the three months ended June 30, 2021, Opiant recorded
approximately $11.3 million in revenue, compared to
approximately $6.3 million during the corresponding
period of 2020. For the three months ended June 30, 2021, the
Company recorded approximately $9.3 million of revenue
from its license agreement with Emergent BioSolutions, Inc. (“EBS”)
for the sale of NARCAN®, compared to approximately $6.3
million in the same period of 2020. Second quarter 2021 sales
of NARCAN® were approximately $106.2 million, as reported by
EBS. For the three months ended June 30, 2021, the Company
recorded approximately $1.9 million in grant and contract
revenue compared to approximately $0.1 million in the same period
in 2020. The $3.0 million increase in revenue from our license
agreement with EBS was primarily due to a $33.4 million increase in
net NARCAN® sales in the three months ended June 30, 2021, compared
to the three months ended June 30, 2020. The $1.8 million increase
in grant and contract revenue was due to the increased funding
received from the National Institute of Drug Abuse (“NIDA”) and
Biomedical Advanced Research and Development Authority (“BARDA”)
for the development of OPNT003.
For the three months ended June 30, 2021, general and
administrative (“G&A”) expenses were approximately $2.7
million, as compared to approximately $2.8 million in the
comparable period in 2020.
Research and development (“R&D”) expenses for the three
months ended June 30, 2021, were approximately $3.2 million,
as compared to approximately $0.6 million in the comparable period
in 2020. External development expense increased by $2.6 million due
to increased activity on the Company’s lead product candidate,
OPNT003, nasal nalmefene.
Sales and marketing (“S&M”) expenses for the three months
ended June 30, 2021, were approximately $1.0 million for
pre-commercialization efforts related to OPNT003, nasal nalmefene.
Sales and marketing expense during the three months ended June 30,
2020, were approximately $1.7 million.
Royalty expense for the three months ended June 30, 2021, was
approximately $2.1 million and $1.4 million for the comparable
period of 2020. The $0.7 million increase was due to increased
royalty revenue from net sales of NARCAN®.
Net income for the three months ended June 30, 2021, was
approximately $1.7 million, or income of $0.39 per basic
share and $0.31 diluted share, compared to net loss of
approximately $0.2 million, or a loss of $0.05 per basic
and diluted share, for the comparable period of 2020.
Financial Results for the Six Months Ended June 30,
2021 For the six months ended June 30, 2021, Opiant
recorded approximately $17.6 million in revenue, compared
to approximately $10.6 million during the corresponding
period of 2020. For the six months ended June 30, 2021, the
Company recorded approximately $13.6 million of revenue
from the sale of NARCAN®, compared to approximately $10.5
million in the same period of 2020. First half 2021 sales of
NARCAN® were approximately $180.4 million, as reported by EBS.
For the six months ended June 30, 2021, the Company recorded
approximately $4.0 million in grant and contract revenue
compared to approximately $0.1 million in the same period in 2020.
The $3.1 million increase in revenue from our license agreement
with EBS was primarily due to a $35.5 million increase in net
NARCAN® sales in the six months ended June 30, 2021, compared to
the six months ended June 30, 2020. The $3.9 million increase in
grant and contract revenue was due to the increased funding
received from NIDA and BARDA for the development of OPNT003.
For the six months ended June 30, 2021 and June 30, 2020,
G&A expenses were approximately $5.4 million.
R&D expenses for the six months ended June 30, 2021, were
approximately $7.2 million, as compared to approximately $2.0
million in the comparable period in 2020. External development
expense increased by $5.2 million due to increased activity on the
Company’s lead product candidate, OPNT003, nasal nalmefene.
S&M expenses for the six months ended June 30, 2021, were
approximately $2.0 million compared to approximately $2.8 million
in the comparable period in 2020.
Royalty expense for the six months ended June 30, 2021, was
approximately $3.1 million, compared to approximately $2.3 million
for the comparable period of 2020. The $0.7 million increase was
due to increased royalty revenue from the net sale of NARCAN®.
Net loss for the six months ended June 30, 2021, was
approximately $1.2 million, or a loss of $0.27 per basic
and diluted share, compared to net loss of
approximately $1.9 million, or a loss of $0.45 per basic
and diluted share, for the comparable period of 2020.
As of June 30, 2021, Opiant had $48.5 million in cash, cash
equivalents, and marketable securities.
Opiant is raising its 2021 financial guidance, reflecting higher
than expected sales of NARCAN® nasal spray. Aligning its
guidance to the upper-range of the full-year 2021 guidance for
sales of NARCAN® Nasal Spray provided by EBS, of $325 million,
Opiant expects full-year 2021 royalty revenue from the sale of
NARCAN® Nasal Spray of approximately $28.9 million. The Company is
also updating its guidance for ending cash and now expects to end
2021 with cash, cash equivalents and marketable securities in the
range of approximately $42 million to $44 million, not including
potential receipt of any additional tranches from the convertible
debt deal.
The OPNT003 development project has been funded in part with
Federal funds from the Department of Health and Human Services;
Office of the Assistant Secretary for Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
Contract No. HHSO100201800029C.
Conference Call Details: |
Thursday, August 5th at 4:30 p.m. Eastern
Time/1:30 p.m. Pacific Time |
Toll
Free: |
888-394-8218 |
International: |
323-794-2588 |
Conference ID: |
5960603 |
Webcast: |
http://ir.opiant.com/ |
About Opiant Pharmaceuticals, Inc.Opiant
Pharmaceuticals, Inc., the company that developed NARCAN® Nasal
Spray, is building a leading franchise of new medicines
to combat addictions and drug overdose.
For more information visit: www.opiant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including anticipated results
and timing of the receipt of data from our PD study and timing of
filing of an NDA and statements regarding updated royalty revenue
guidance and ending cash target in 2021. These statements relate to
future events or our future financial performance and involve known
and unknown risks, uncertainties and other factors that may cause
our or our industry’s actual results, levels of activity,
performance or achievements to be materially different from any
future results, levels of activity, performance or achievements
expressed, implied or inferred by these forward-looking statements,
and among other things, our ability to maintain cash balances and
successfully commercialize or partner our product candidates
currently under development. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,”
“should,” “could," “would,” “expects,” “plans,” “intends,”
“anticipates,” “believes,” “estimates,” “predicts,” “projects,”
“potential,” or “continue” or the negative of such terms and other
same terminology. These statements are only predictions based on
our current expectations and projections about future events. You
should not place undue reliance on these statements. Actual events
or results may differ materially. In evaluating these statements,
you should specifically consider various factors. Additional
factors that could materially affect actual results can be found in
our filed quarterly reports on Form 10-Q and our annual report on
Form 10-K for the year ended December 31, 2020, filed with
the Securities and Exchange Commission on March 4,
2021, including under the caption titled “Risk Factors.” These and
other factors may cause our actual results to differ materially
from any forward-looking statement. We undertake no obligation to
update any of the forward-looking statements after the date of this
press release to conform those statements to reflect the occurrence
of unanticipated events, except as required by applicable
law.Investor Relations Contacts:
Ben AtkinsVP of Corporate Communications and
Investor RelationsBatkins@opiant.com(310) 598-5410
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Opiant Pharmaceuticals Inc. |
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Condensed Consolidated Statements of
Operations |
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|
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(in thousands, except shares and per share
amounts) |
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Three months ended |
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Three months ended |
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Six months ended |
|
Six months ended |
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|
June 30 |
|
June 30 |
|
June 30 |
|
June 30 |
|
|
|
|
|
|
2021 |
|
|
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2020 |
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|
2021 |
|
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|
2020 |
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
Revenues |
|
|
|
|
|
|
|
|
|
|
Royalty
revenue |
|
|
$ |
9,314 |
|
|
$ |
6,258 |
|
|
$ |
13,648 |
|
|
$ |
10,456 |
|
|
Grant and contract
revenue |
|
|
|
1,945 |
|
|
|
55 |
|
|
|
3,998 |
|
|
|
139 |
|
|
|
Total Revenue |
|
|
|
11,259 |
|
|
|
6,313 |
|
|
|
17,646 |
|
|
|
10,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
General and
administrative |
|
|
|
2,733 |
|
|
|
2,836 |
|
|
|
5,380 |
|
|
|
5,410 |
|
|
Research and
development |
|
|
|
3,150 |
|
|
|
558 |
|
|
|
7,238 |
|
|
|
1,979 |
|
|
Sales &
marketing |
|
|
|
1,023 |
|
|
|
1,747 |
|
|
|
2,020 |
|
|
|
2,823 |
|
|
Royalty
expense |
|
|
|
2,107 |
|
|
|
1,403 |
|
|
|
3,086 |
|
|
|
2,337 |
|
|
|
Total expenses |
|
|
|
9,013 |
|
|
|
6,544 |
|
|
|
17,724 |
|
|
|
12,549 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations |
|
|
|
2,246 |
|
|
|
(231 |
) |
|
|
(78 |
) |
|
|
(1,954 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
|
4 |
|
|
|
11 |
|
|
|
7 |
|
|
|
88 |
|
|
Interest
expense |
|
|
|
(542 |
) |
|
|
- |
|
|
|
(1,079 |
) |
|
|
- |
|
|
Loss on foreign
exchange |
|
|
|
(24 |
) |
|
|
4 |
|
|
|
(10 |
) |
|
|
4 |
|
|
|
Total other income
(expense) |
|
|
(562 |
) |
|
|
15 |
|
|
|
(1,082 |
) |
|
|
92 |
|
Income (loss)
before provision for income taxes |
|
|
1,684 |
|
|
|
(216 |
) |
|
|
(1,160 |
) |
|
|
(1,862 |
) |
|
Income tax
expense |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
39 |
|
Net income
(loss) |
|
|
$ |
1,684 |
|
|
$ |
(216 |
) |
|
$ |
(1,160 |
) |
|
$ |
(1,901 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustment |
|
|
(5 |
) |
|
|
(17 |
) |
|
|
8 |
|
|
|
(311 |
) |
Comprehensive
income (loss) |
|
|
$ |
1,679 |
|
|
$ |
(233 |
) |
|
$ |
(1,152 |
) |
|
$ |
(2,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per common share |
|
|
|
|
|
|
|
|
|
Basic |
|
|
$ |
0.39 |
|
|
$ |
(0.05 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.45 |
) |
|
Diluted |
|
|
$ |
0.31 |
|
|
$ |
(0.05 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
4,332,601 |
|
|
|
4,258,105 |
|
|
|
4,308,027 |
|
|
|
4,241,423 |
|
|
Diluted |
|
|
|
5,427,831 |
|
|
|
4,258,105 |
|
|
|
4,308,027 |
|
|
|
4,241,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opiant Pharmaceuticals, Inc. |
|
|
|
|
|
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Condensed Consolidated Balance Sheets |
|
|
|
|
|
|
|
(in thousands, except shares and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
(unaudited) |
|
|
|
Current
assets |
|
|
|
|
|
|
|
Cash & cash
equivalents |
|
|
$ |
33,443 |
|
|
$ |
48,251 |
|
|
|
Marketable securities |
|
|
|
15,072 |
|
|
|
- |
|
|
|
Accounts receivable |
|
|
|
9,726 |
|
|
|
8,911 |
|
|
|
Prepaid expenses
and other current assets |
|
|
2,277 |
|
|
|
1,937 |
|
|
|
Total current assets |
|
|
|
60,518 |
|
|
|
59,099 |
|
|
Other assets |
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
|
109 |
|
|
|
171 |
|
|
|
Right of use
assets - operating leases |
|
|
1,119 |
|
|
|
279 |
|
|
|
Patents and patent
applications, net |
|
|
12 |
|
|
|
13 |
|
|
|
Other non-current assets |
|
|
|
- |
|
|
|
1,051 |
|
|
|
Total assets |
|
|
$ |
61,758 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
$ |
2,447 |
|
|
$ |
2,966 |
|
|
|
Accrued salaries and
wages |
|
|
|
891 |
|
|
|
909 |
|
|
|
Royalty payable |
|
|
|
2,107 |
|
|
|
1,908 |
|
|
|
Deferred revenue |
|
|
|
- |
|
|
|
355 |
|
|
|
Operating leases |
|
|
|
339 |
|
|
|
282 |
|
|
|
Total current liabilities |
|
|
|
5,784 |
|
|
|
6,420 |
|
|
Long-term
liabilities |
|
|
|
|
|
|
|
Operating leases |
|
|
|
781 |
|
|
|
- |
|
|
|
Convertible debt,
net of unamortized discount |
|
|
18,837 |
|
|
|
18,701 |
|
|
|
Total long-term liabilities |
|
|
|
19,618 |
|
|
|
18,701 |
|
|
|
Total liabilities |
|
|
|
25,402 |
|
|
|
25,121 |
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock,
$0.001 par value, 200,000,000 shares |
|
|
|
|
|
|
authorized,
4,349,599 and 4,258,105 shares |
|
|
|
|
|
|
issued and
outstanding at June 30, 2021 |
|
|
|
|
|
|
and December 31,
2020, respectively |
|
|
4 |
|
|
|
4 |
|
|
Additional
paid-in-capital |
|
|
|
102,220 |
|
|
|
100,204 |
|
|
Accumulated other
comprehensive loss |
|
|
(19 |
) |
|
|
(27 |
) |
|
Accumulated
deficit |
|
|
|
(65,849 |
) |
|
|
(64,689 |
) |
|
|
Total stockholders’
equity |
|
|
|
36,356 |
|
|
|
35,492 |
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
61,758 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
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