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 twelve months ended December 31, 2021, and provided a
corporate update. Recent highlights include:
Finance Update
- Q4 revenues of $13.8 million, an increase of 39% compared to
the same period in 2020
- Exceeded full-year 2021 royalty revenue guidance of
approximately $38 million with 2021 royalty revenue of
approximately $41 million, a 49% increase over full-year 2020
- Full-year net income of $3.0 million
- Well capitalized, with approximately $53.0 million in
cash, cash equivalents and marketable securities, as of December
31, 2021
Pipeline Update
- OPNT003, nasal nalmefene, for opioid overdose:
- Reported positive topline results from pharmacokinetic (“PK”),
safety and tolerability multidose study
- Completed enrollment in pharmacodynamic (“PD”) study comparing
nasal nalmefene and nasal naloxone, with top line data now expected
in Q2 2022
- Pre-NDA Meeting with the FDA scheduled for late March 2022
- Targeting New Drug Application (“NDA”) submission mid-year
2022; commercial preparations well underway for a potential
commercial launch in 2023
- OPNT002, nasal naltrexone, for Alcohol Use Disorder (“AUD”):
- Initiated patient dosing in Phase 2 study, with data expected
in H1 2023
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“Opiant delivered strong financial results in 2021, and
continued pipeline momentum, led by OPNT003, nasal nalmefene. We
believe the compelling results generated to date from our ongoing
development program support OPNT003’s potential to be a
differentiated treatment option for the emergency treatment of
opioid overdose, particularly in the community setting. In
parallel, we initiated dosing in our Phase 2 study for Alcohol Use
Disorder, an important advancement for our deep pipeline aimed at
bringing about a paradigm shift in the treatment of addictions and
drug overdose. Looking ahead, with the clinical portion of our work
complete, we look forward to the upcoming top line data from the PD
study and remain dedicated to progressing OPNT003 to NDA
submission, as well as the continued growth of our commercial
organization in preparation for a potential launch in the U.S.”
David O’Toole, Chief Financial Officer of Opiant, said:
“We ended the year with approximately $53 million of cash
and continue to prudently manage our capital resources, providing
us with a strong financial foundation to support our commercial and
R&D initiatives. Based on our anticipated upcoming catalysts
and product pipeline, we believe we are well-positioned to drive
increasing value for all key stakeholders.”
Financial Results for the Fourth Quarter
Ended December 31, 2021For the three months
ended December 31, 2021, Opiant recorded
approximately $13.8 million in revenue, compared to
approximately $10.0 million during the corresponding
period of 2020. $13.0 million of revenue was attributable to
the license agreement with Emergent BioSolutions, Inc. (“EBS”) for
the sale of NARCAN® Nasal Spray, compared to
approximately $8.3 million in the same period of 2020,
and approximately $0.8 million came from grant and contract
revenue, compared to approximately $1.6 million in the same period
in 2020. Fourth quarter 2021 sales of NARCAN® Nasal Spray were
approximately $120.6 million, as reported by EBS.
For the three months ended December 31, 2021, general and
administrative (“G&A”) expenses were approximately $3.4
million, as compared to approximately $3.6 million in the
comparable period in 2020.
Research and development (“R&D”) expenses for the three
months ended December 31, 2021, were approximately $4.7
million, as compared to approximately $4.5 million in the
comparable period in 2020.
Sales and marketing (“S&M”) expenses for the three months
ended December 31, 2021, were approximately $1.5 million for
pre-commercialization efforts related to OPNT003. Sales and
marketing expense during the three months ended December 31, 2020,
were approximately $0.9 million.
Royalty expense for the three months ended December 31, 2021,
was approximately $2.9 million and $1.9 million for the comparable
period of 2020. The $1.0 million increase was due to increased
royalty revenue from net sales of NARCAN® Nasal Spray.
Net income for the three months ended December 31, 2021,
was approximately $0.8 million, or income of $0.17 per
basic share and $0.11 per diluted share, compared to a net
loss of approximately $0.7 million, or loss of $0.16 per
basic and diluted share, for the comparable period of
2020.
Financial Results for the 12 Months Ended December 31,
2021
For the twelve months ended December 31, 2021, Opiant
recorded approximately $47.8 million in revenue, compared
to approximately $29.6 million during the corresponding
period of 2020. For the twelve months ended December 31, 2021,
the Company recorded approximately $40.7 million of
revenue from the sale of NARCAN® Nasal Spray, compared to
approximately $27.4 million in the same period of 2020.
Sales of NARCAN® Nasal Spray for the twelve months
ended December 31, 2021, were approximately $434.3
million, as reported by EBS.
For the twelve months ended December 31, 2021, the Company
recorded approximately $7.1 million in grant and contract
revenue compared to approximately $2.2 million in the same period
in 2020. The $4.9 million increase in grant and contract revenue
was due to the increased funding received from the National
Institute of Drug Abuse and Biomedical Advanced Research and
Development Authority for the development of OPNT003.
For the twelve months ended December 31, 2021, G&A
expenses were approximately $12.2 million, compared to
approximately $11.7 million in the comparable period in 2020.
R&D expenses for the twelve months ended December 31,
2021, were approximately $16.8 million, as compared to
approximately $9.2 million in the comparable period in 2020.
R&D expense increased by $7.6 million primarily due to
increased activity on OPNT003.
S&M expenses for the twelve months ended December 31,
2021, were approximately $4.6 million compared to approximately
$4.7 million in the comparable period in 2020.
Royalty expense for the twelve months ended December 31,
2021, was approximately $9.1 million, compared to approximately
$6.2 million for the comparable period of 2020. The $2.9 million
increase was due to increased royalty revenue from net sales of
NARCAN® Nasal Spray.
Net income for the twelve months ended December 31, 2021,
was approximately $3.0 million, or income of $0.68 per
basic share and income of $0.51 per diluted share, compared to
net loss of approximately $1.9 million, or a loss of
$0.44 per basic and diluted share, for the comparable period
of 2020.
As of December 31, 2021, Opiant had approximately $53.0
million in cash, cash equivalents, and marketable securities.
We are not providing royalty revenue guidance, currently, due to
the uncertainty of the level of sales of NARCAN® Nasal Spray in
2022. We intend to provide guidance later in 2022, once we
determine the potential impact of the launch in December of 2021 of
a generic equivalent by Teva Pharmaceuticals.
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: |
Tuesday, March 15th at 4:30 p.m. Eastern
Time/1:30 p.m. Pacific Time |
Toll Free: |
1-877-407-0792 |
International: |
1-201-689-8263 |
Conference ID: |
13726931 |
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. 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, 2021, filed with the Securities and
Exchange Commission on March 15, 2022, 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
Opiant
Pharmaceuticals Inc. |
|
Consolidated
Statements of Operations and Comprehensive Income
(Loss) |
|
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended |
|
Year
ended |
|
Three months
ended |
|
Three months
ended |
|
|
|
|
|
December 31, |
|
December 31, |
|
December 31, |
|
December 31, |
|
|
|
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
Royalty revenue |
|
$ |
40,725 |
|
|
$ |
27,402 |
|
|
$ |
13,036 |
|
|
$ |
8,345 |
|
|
|
Grant and contract revenue |
|
|
7,060 |
|
|
|
2,223 |
|
|
|
764 |
|
|
|
1,579 |
|
|
|
|
Total revenue |
|
|
47,785 |
|
|
|
29,625 |
|
|
|
13,800 |
|
|
|
9,924 |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
12,153 |
|
|
|
11,742 |
|
|
|
3,394 |
|
|
|
3,604 |
|
|
|
Research and development |
|
|
16,834 |
|
|
|
9,240 |
|
|
|
4,715 |
|
|
|
4,477 |
|
|
|
Sales & marketing |
|
|
4,576 |
|
|
|
4,687 |
|
|
|
1,496 |
|
|
|
949 |
|
|
|
Royalty expense |
|
|
9,066 |
|
|
|
6,197 |
|
|
|
2,921 |
|
|
|
1,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
expenses |
|
|
42,629 |
|
|
|
31,866 |
|
|
|
12,526 |
|
|
|
10,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income (loss) |
|
|
5,156 |
|
|
|
(2,241 |
) |
|
|
1,274 |
|
|
|
(1,014 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
11 |
|
|
|
94 |
|
|
|
1 |
|
|
|
2 |
|
|
|
Interest expense |
|
|
(2,129 |
) |
|
|
(131 |
) |
|
|
(503 |
) |
|
|
(131 |
) |
|
|
Gain (loss) on foreign exchange |
|
|
(5 |
) |
|
|
(9 |
) |
|
|
4 |
|
|
|
(7 |
) |
|
|
|
Total other
income |
|
|
(2,123 |
) |
|
|
(46 |
) |
|
|
(498 |
) |
|
|
(136 |
) |
|
Net income (loss) before income taxes |
|
|
3,033 |
|
|
|
(2,287 |
) |
|
|
776 |
|
|
|
(1,150 |
) |
|
Income tax benefit (expense) |
|
|
(24 |
) |
|
|
426 |
|
|
|
27 |
|
|
|
465 |
|
|
Net income (loss) |
|
$ |
3,009 |
|
|
$ |
(1,861 |
) |
|
$ |
803 |
|
|
$ |
(685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(28 |
) |
|
|
(27 |
) |
|
|
(27 |
) |
|
|
88 |
|
|
Total other comprehensive income (loss) |
|
$ |
2,981 |
|
|
$ |
(1,888 |
) |
|
$ |
776 |
|
|
$ |
(597 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share |
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.68 |
|
|
$ |
(0.44 |
) |
|
$ |
0.17 |
|
|
$ |
(0.16 |
) |
|
|
Diluted |
|
$ |
0.51 |
|
|
$ |
(0.44 |
) |
|
$ |
0.11 |
|
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
4,456,162 |
|
|
|
4,249,832 |
|
|
|
4,742,530 |
|
|
|
4,258,105 |
|
|
|
Diluted |
|
|
5,920,069 |
|
|
|
4,249,832 |
|
|
|
7,111,376 |
|
|
|
4,258,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opiant
Pharmaceuticals, Inc. |
|
Consolidated
Balance Sheets |
|
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
December 31, |
|
As of
December 31, |
|
|
|
|
|
2021 |
|
2020 |
|
Assets |
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash &
cash equivalents |
|
|
$ |
37,854 |
|
|
$ |
48,251 |
|
|
|
|
Marketable
securities |
|
|
|
15,015 |
|
|
|
- |
|
|
|
|
Accounts
receivable |
|
|
|
13,327 |
|
|
|
8,911 |
|
|
|
|
Prepaid
expenses and other current assets |
|
|
|
2,963 |
|
|
|
1,937 |
|
|
|
|
Total Current Assets |
|
|
|
69,159 |
|
|
|
59,099 |
|
|
|
Long-term Assets |
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
|
78 |
|
|
|
171 |
|
|
|
|
Right of use
assets - operating leases |
|
|
|
1,000 |
|
|
|
279 |
|
|
|
|
Patents and
patent applications, net |
|
|
|
12 |
|
|
|
13 |
|
|
|
|
Other
non-current assets |
|
|
|
179 |
|
|
|
1,051 |
|
|
|
|
Total Assets |
|
|
$ |
70,428 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
|
$ |
3,370 |
|
|
$ |
2,966 |
|
|
|
|
Accrued
salaries and wages |
|
|
|
201 |
|
|
|
909 |
|
|
|
|
Royalty
payable |
|
|
|
2,920 |
|
|
|
1,908 |
|
|
|
|
Deferred
revenue |
|
|
|
17 |
|
|
|
355 |
|
|
|
|
Operating
leases - current |
|
|
|
338 |
|
|
|
282 |
|
|
|
|
Total Current Liabilities |
|
|
|
6,846 |
|
|
|
6,420 |
|
|
|
Long-Term Liabilities |
|
|
|
|
|
|
|
|
Operating
leases - long term |
|
|
|
673 |
|
|
|
- |
|
|
|
|
Convertible
debt, net of issuance costs |
|
|
|
16,069 |
|
|
|
18,701 |
|
|
|
|
Total Long-Term Liabilities |
|
|
|
16,742 |
|
|
|
18,701 |
|
|
|
|
Total Liabilities |
|
|
|
23,588 |
|
|
|
25,121 |
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares |
|
|
|
|
|
|
|
|
authorized,
4,909,846 and 4,258,105 shares |
|
|
|
|
|
|
|
|
issued and outstanding at December 31, 2021 and 2020, |
|
|
|
|
|
|
respectively |
|
|
|
5 |
|
|
|
4 |
|
|
|
Additional paid-in-capital |
|
|
|
108,570 |
|
|
|
100,204 |
|
|
|
Accumulated other comprehensive loss |
|
|
|
(55 |
) |
|
|
(27 |
) |
|
|
Accumulated deficit |
|
|
|
(61,680 |
) |
|
|
(64,689 |
) |
|
|
|
Total
stockholders' equity |
|
|
|
46,840 |
|
|
|
35,492 |
|
|
|
|
Total liabilities and stockholders' equity |
|
|
$ |
70,428 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
|
|
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