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 nine months ended September 30, 2021, and provided a
corporate update. Recent highlights include:
Finance Update
- Q3 revenues of $16.3 million, a 79% increase
over the same period in 2020, driven by NARCAN® Nasal Spray
royalties
- Nine-month revenues of $34 million
- $50.3 million in cash, cash equivalents and marketable
securities (as of September 30, 2021)
- Raises full-year 2021 revenue and cash
guidance
- Royalty revenue from the sale of NARCAN® Nasal Spray now
anticipated to be approximately $38 million
- Cash, cash equivalents and marketable securities now expected
to be in the range of approximately $50 million to $52 million, an
increase of approximately $8 million greater than 2nd quarter
guidance
Pipeline Update
- OPNT003, nasal nalmefene, for opioid overdose:
- Obtained U.S. Food and Drug Administration (“FDA”) Fast-Track
Designation for OPNT003
- Enrollment and dosing of subjects in Pharmacodynamic (“PD”)
study is progressing. The PD study is designed as a non-inferiority
study comparing OPNT003 to nasal naloxone to reverse the
respiratory depression produced by the synthetic opioid
remifentanil, by measuring change in minute ventilation. Company is
on track to complete the clinical phase of the study by the end of
2021 with top-line data now anticipated in Q1 2022
- Targeting NDA submission under Fast-Track designation during
the first half of 2022, with commercial preparations underway for a
potential launch in Q4 2022
- OPNT002, nasal naltrexone, for Alcohol Use Disorder
(“AUD”): Announces its plans to initiate patient
recruitment for Phase 2 clinical study in Q4 2021
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“Opiant demonstrated strong performance again this quarter with
continued positive momentum for OPNT003, nasal nalmefene, for
opioid overdose. Following positive PK data, we were pleased this
month to receive FDA Fast-Track designation. We are making good
progress in our PD study and anticipate top-line results in the
first quarter of 2022. In parallel, we continue to invest in and
advance preparations for a potential commercial launch in 2022, if
approved. We are also looking forward in Q4 this year to initiating
our Phase 2 study of OPNT002, nasal naltrexone, for Alcohol Use
Disorder, which we had put on hold due to COVID.”
David O’Toole, Chief Financial Officer of Opiant, said:
“During Q3, we saw continued and strong revenue growth
attributable to our royalties on significant net sales this quarter
of NARCAN® Nasal Spray, a further indicator of the demand for
opioid overdose treatment in the U.S. As we look forward to a
potential launch of OPNT003 in the latter half of 2022, our
expected strong cash position at the end of 2021, will support the
commercial plan and the progression of the pipeline.”
Financial Results for the Three Months Ended September
30, 2021
For the three months ended September 30, 2021, Opiant
recorded approximately $16.3 million in revenue, compared
to approximately $9.1 million during the corresponding
period of 2020. For the three months ended September 30, 2021,
the Company recorded approximately $14 million of revenue
from its license agreement with Emergent BioSolutions, Inc. (“EBS”)
for the sale of NARCAN® Nasal Spray, compared to
approximately $8.6 million in the same period of 2020.
Third quarter 2021 sales of NARCAN® Nasal Spray were
approximately $133.3 million, as reported by EBS. For the
three months ended September 30, 2021, the Company recorded
approximately $2.3 million in grant and contract revenue
compared to approximately $0.5 million in the same period in 2020.
The $5.4 million increase in revenue from our license agreement
with EBS was primarily due to a $44.5 million increase in net
NARCAN® Nasal Spray sales in the three months ended September 30,
2021, compared to the three months ended September 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 September 30, 2021, general and
administrative (“G&A”) expenses were approximately $3.4
million, as compared to approximately $2.7 million in the
comparable period in 2020.
Research and development (“R&D”) expenses for the three
months ended September 30, 2021, were approximately $4.9
million, as compared to approximately $2.8 million in the
comparable period in 2020. Development expense increased by $2.1
million primarily due to increased activity on OPNT003.
Sales and marketing (“S&M”) expenses for the three months
ended September 30, 2021, were approximately $1.1 million for
pre-commercialization efforts related to OPNT003. Sales and
marketing expense during the three months ended September 30, 2020,
were approximately $0.9 million.
Royalty expense for the three months ended September 30, 2021,
was approximately $3.1 million and $2.0 million for the comparable
period of 2020. The $1.1 million increase was due to increased
royalty revenue from net sales of NARCAN® Nasal Spray.
Net income for the three months ended September 30, 2021,
was approximately $3.4 million, or income of $0.77 per
basic share and $0.56 diluted share, compared to net income of
approximately $0.7 million, or income of $0.17 per basic
and $0.15 per diluted share, for the comparable period of
2020.
Financial Results for the Nine Months Ended September
30, 2021
For the nine months ended September 30, 2021, Opiant
recorded approximately $34 million in revenue, compared
to approximately $19.7 million during the corresponding
period of 2020. For the nine months ended September 30, 2021,
the Company recorded approximately $27.7 million of
revenue from the sale of NARCAN® Nasal Spray, compared to
approximately $19.1 million in the same period of 2020.
Sales of NARCAN® Nasal Spray for the nine months
ended September 30, were approximately $313.7 million, as
reported by EBS. For the nine months ended September 30, 2021,
the Company recorded approximately $6.3 million in grant and
contract revenue compared to approximately $0.6 million in the same
period in 2020. The $8.6 million increase in revenue from our
license agreement with EBS was primarily due to a $80.0 million
increase in net NARCAN® Nasal Spray sales in the nine months ended
September 30, 2021, compared to the nine months ended September 30,
2020. The $5.7 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 nine months ended September 30, 2021, G&A
expenses were approximately $8.7 million, compared to
approximately $8.1 million in the comparable period in 2020.
R&D expenses for the nine months ended September 30,
2021, were approximately $12.1 million, as compared to
approximately $4.8 million in the comparable period in 2020.
Development expense increased by $7.3 million primarily due to
increased activity on OPNT003.
S&M expenses for the nine months ended September 30,
2021, were approximately $3.0 million compared to approximately
$3.7 million in the comparable period in 2020.
Royalty expense for the nine months ended September 30,
2021, was approximately $6.1 million, compared to approximately
$4.3 million for the comparable period of 2020. The $1.8 million
increase was due to increased royalty revenue from net sales of
NARCAN®.
Net income for the nine months ended September 30, 2021,
was approximately $2.3 million, or income of $0.52 per
basic share and income of $0.41 per diluted share, compared to
net loss of approximately $1.2 million, or a loss of
$0.28 per basic and diluted share, for the comparable period
of 2020.
As of September 30, 2021, Opiant had $50.3 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 $420 million,
Opiant expects full-year 2021 royalty revenue from the sale of
NARCAN® Nasal Spray of approximately $38 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 $50 million to $52 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,
November 11th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific
Time
Toll
Free: |
877-407-0792 |
International: |
201-689-8263 |
Conference ID: |
13723604 |
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
|
|
|
Opiant
Pharmaceuticals, Inc. |
|
|
|
|
Condensed
Consolidated Balance Sheets |
|
|
|
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
As of
September 30, |
|
As of
December 31, |
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Assets |
|
(unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash &
cash equivalents |
|
$ |
35,285 |
|
|
$ |
48,251 |
|
|
|
|
Marketable
securities |
|
|
15,045 |
|
|
|
- |
|
|
|
|
Accounts
receivable |
|
|
15,426 |
|
|
|
8,911 |
|
|
|
|
Prepaid
expenses and other current assets |
|
|
2,121 |
|
|
|
1,937 |
|
|
|
|
Total current assets |
|
|
67,877 |
|
|
|
59,099 |
|
|
|
Other assets |
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
93 |
|
|
|
171 |
|
|
|
|
Right of use
assets - operating leases |
|
|
998 |
|
|
|
279 |
|
|
|
|
Patents and
patent applications, net |
|
|
12 |
|
|
|
13 |
|
|
|
|
Other
non-current assets |
|
|
- |
|
|
|
1,051 |
|
|
|
|
Total assets |
|
$ |
68,980 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
2,581 |
|
|
$ |
2,966 |
|
|
|
|
Accrued
salaries and wages |
|
|
1,347 |
|
|
|
909 |
|
|
|
|
Royalty
payable |
|
|
3,137 |
|
|
|
1,908 |
|
|
|
|
Deferred
revenue |
|
|
- |
|
|
|
355 |
|
|
|
|
Operating
leases |
|
|
287 |
|
|
|
282 |
|
|
|
|
Total current liabilities |
|
|
7,352 |
|
|
|
6,420 |
|
|
|
Long-term liabilities |
|
|
|
|
|
|
|
Operating
leases |
|
|
716 |
|
|
|
- |
|
|
|
|
Convertible
debt, net of unamortized discount |
|
|
18,906 |
|
|
|
18,701 |
|
|
|
|
Total long-term liabilities |
|
|
19,622 |
|
|
|
18,701 |
|
|
|
|
Total liabilities |
|
|
26,974 |
|
|
|
25,121 |
|
|
|
Stockholders' equity |
|
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares |
|
|
|
|
|
|
|
authorized,
4,618,221 and 4,258,105 shares |
|
|
|
|
|
|
|
issued and
outstanding at September 30, 2021 |
|
|
|
|
|
|
|
and December
31, 2020, respectively |
|
|
5 |
|
|
|
4 |
|
|
|
Additional paid-in-capital |
|
|
104,460 |
|
|
|
100,204 |
|
|
|
Accumulated other comprehensive loss |
|
|
(27 |
) |
|
|
(27 |
) |
|
|
Accumulated deficit |
|
|
(62,432 |
) |
|
|
(64,689 |
) |
|
|
|
Total
stockholders' equity |
|
|
42,006 |
|
|
|
35,492 |
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
68,980 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Opiant
Pharmaceuticals Inc. |
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations |
|
|
|
|
|
|
|
|
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Three months
ended |
|
Nine months
ended |
|
Nine months
ended |
|
|
|
|
|
September 30 |
|
September 30 |
|
September 30 |
|
September 30 |
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Royalty revenue |
|
|
$ |
14,041 |
|
|
$ |
8,601 |
|
|
$ |
27,689 |
|
|
$ |
19,057 |
|
|
|
Grant and contract revenue |
|
|
|
2,298 |
|
|
|
505 |
|
|
|
6,296 |
|
|
|
644 |
|
|
|
|
Total
Revenue |
|
|
|
16,339 |
|
|
|
9,106 |
|
|
|
33,985 |
|
|
|
19,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
3,379 |
|
|
|
2,729 |
|
|
|
8,759 |
|
|
|
8,138 |
|
|
|
Research and development |
|
|
|
4,881 |
|
|
|
2,784 |
|
|
|
12,119 |
|
|
|
4,763 |
|
|
|
Sales & marketing |
|
|
|
1,060 |
|
|
|
914 |
|
|
|
3,080 |
|
|
|
3,738 |
|
|
|
Royalty expense |
|
|
|
3,059 |
|
|
|
1,952 |
|
|
|
6,145 |
|
|
|
4,289 |
|
|
|
|
Total
expenses |
|
|
|
12,379 |
|
|
|
8,379 |
|
|
|
30,103 |
|
|
|
20,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
|
3,960 |
|
|
|
727 |
|
|
|
3,882 |
|
|
|
(1,227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
4 |
|
|
|
4 |
|
|
|
10 |
|
|
|
92 |
|
|
|
Interest expense |
|
|
|
(547 |
) |
|
|
- |
|
|
|
(1,626 |
) |
|
|
- |
|
|
|
Gain (loss) on foreign exchange |
|
|
|
- |
|
|
|
(6 |
) |
|
|
(10 |
) |
|
|
(2 |
) |
|
|
|
Total other
income (expense) |
|
|
|
(543 |
) |
|
|
(2 |
) |
|
|
(1,626 |
) |
|
|
90 |
|
|
Income (loss) before provision for income taxes |
|
|
3,417 |
|
|
|
725 |
|
|
|
2,256 |
|
|
|
(1,137 |
) |
|
|
Income tax expense |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
39 |
|
|
Net income (loss) |
|
|
$ |
3,417 |
|
|
$ |
725 |
|
|
$ |
2,256 |
|
|
$ |
(1,176 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
(8 |
) |
|
|
196 |
|
|
|
1 |
|
|
|
(115 |
) |
|
Comprehensive income (loss) |
|
|
$ |
3,409 |
|
|
$ |
921 |
|
|
$ |
2,257 |
|
|
$ |
(1,291 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
$ |
0.77 |
|
|
$ |
0.17 |
|
|
$ |
0.52 |
|
|
$ |
(0.28 |
) |
|
|
Diluted |
|
|
$ |
0.56 |
|
|
$ |
0.15 |
|
|
$ |
0.41 |
|
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
4,462,236 |
|
|
|
4,258,105 |
|
|
|
4,359,759 |
|
|
|
4,247,045 |
|
|
|
Diluted |
|
|
|
6,065,044 |
|
|
|
4,847,211 |
|
|
|
5,565,065 |
|
|
|
4,247,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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