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 months and six months ended June 30, 2022, and provided a
corporate update. Recent highlights include:
Pipeline Update
- Rolling New Drug Application (NDA) submission for OPNT003,
nasal nalmefene for opioid overdose remains on track, with
completion expected in the second half of 2022
- Announced that the United States (U.S.) Patent and Trademark
Office has issued a Notice of Allowance for U.S. patent with claims
covering OPNT003 for opioid overdose
- Enrollment and dosing on track in 300-patient Phase 2 study for
OPNT002, nasal naltrexone, for Alcohol Use Disorder (AUD); data
expected in H1 2023
Finance Update
- Q2 revenues of $3.9 million; $2.3 million of revenue was
attributable to the sales of NARCAN® Nasal Spray from Opiant’s
License Agreement with Emergent BioSolutions, Inc. (EBS)
- EBS communicated that royalties from U.S. NARCAN® sales were
calculated using a 2% rate, despite Q2 2022 U.S. net sales having
been greater than 70% of Q3 2021 thus requiring higher rates
- Opiant delivered to EBS a default notice of material breach of
its License Agreement for failure to pay the royalty rate set out
in the License Agreement
- Announced $2.1 million funding awarded under its contract with
the Biomedical Advanced Research and Development Authority (BARDA)
for OPNT003 nasal nalmefene
- Approximately $40.2 million in cash and cash equivalents, as of
June 30, 2022
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“At Opiant, we feel a strong sense of urgency to meet the need
for new treatment options for opioid overdose, driven largely by
fentanyl and other very potent illicit synthetic opioids, which are
doing so much harm in our communities. We are on track to complete
our NDA this year, and believe that OPNT003, nasal nalmefene, is
particularly well suited to help confront this national overdose
crisis. The value of OPNT003 was further validated by the allowance
of our patent application by the USPTO. By year-end, we also
anticipate completing enrollment in the Phase 2 study
evaluating OPNT002 for the treatment of Alcohol Use Disorder, with
data expected during the first half of next year. I am excited by
the progress we have made and look forward to advancing our mission
to deliver medicines to better treat addiction and drug
overdose.”
David O’Toole, Chief Financial Officer of Opiant, said:
“Looking ahead, we are prudently managing expenses while
maintaining our good financial position with multiple value
creating catalysts expected over the next 12 months. With that
said, we intend to pursue all avenues to ensure the terms of the
NARCAN® licensing agreement are appropriately enforced.”
Financial Results for the Three Months Ended June 30,
2022
For the three months ended June 30, 2022, Opiant recorded
approximately $3.9 million in revenue, compared to
approximately $11.3 million during the corresponding
period of 2021. For the three months ended June 30, 2022, the
Company recorded approximately $2.3 million of revenue
from its license agreement with Emergent BioSolutions, Inc. (EBS)
for the sale of NARCAN®, and $1.6 million from grant and contract
revenue, compared to approximately $9.3 million and $1.9
million respectively in the same period of 2021. Second
quarter 2022 sales of NARCAN® were approximately $101.5
million, as reported by EBS.
For the three months ended June 30, 2022, general and
administrative (G&A) expenses were approximately $4.0
million, as compared to approximately $2.7 million in the
comparable period in 2021. Personnel and non-cash stock-based
compensation expense increased by $1.3 million.
Research and development (R&D) expenses for the three months
ended June 30, 2022, increased by $4.8 million to
$7.9 million, from $3.1 million for the three months
ended June 30, 2021. External development expense increased by $3.9
million primarily due to increased activity on our lead product
candidate, OPNT003, nasal nalmefene, for opioid overdose, and
personnel and non-cash stock-based compensation expense increased
by $0.9 million.
Sales and marketing (S&M) expenses for the three months
ended June 30, 2022, were approximately $2.8 million, as compared
to approximately $1.0 million in the comparable period in 2021.
Personnel and non-cash stock-based compensation expense increased
by $1.1 million and external third party spend related to
pre-commercial activities increased by $0.7 million.
Royalty expense for the three months ended June 30, 2022, was
approximately $0.5 million, compared to $2.1 million in the
comparable period in 2021.
During the three months ended June 30, 2022, interest
expense was $0.4 million compared to $0.5 million during
the three months ended June 30, 2021. Interest expense is all
related to the Company’s convertible debt.
Net loss for the three months ended June 30, 2022, was
approximately $11.8 million, or a loss of $2.31 per basic
share and diluted share, compared to net income of
approximately $1.7 million, or $0.39 per basic and $0.31
per diluted share, for the comparable period of 2021.
On August 10, 2022, Opiant delivered a Default Notice to EBS
under section 10.3 of its License Agreement. The Default Notice put
EBS on notice it had materially breached one or more of its
obligations under the License Agreement. Opiant stated cause for
breach based upon the royalty report EBS provided Opiant for the
quarter ended June 30, 2022. The EBS royalty report confirmed U.S.
net NARCAN® sales during the second quarter were greater than 70%
of the U.S. net NARCAN® sales in the third quarter 2021. As
provided under the License Agreement, the Generic Reduction Clause
would not apply and Opiant should have been entitled to the higher
tiered royalty rate structure. However, EBS arbitrarily applied a
2% rate, disregarding the terms of the License Agreement, and
resulting in a royalty payment of approximately $2.3 million.
Opiant believes that it is due approximately $9.1 million, a
significantly higher royalty payment. The Default Notice allows EBS
sixty days to meet its obligations under the License Agreement and
pay the correct amount owed. If EBS fails do so, Opiant intends to
vigorously pursue all remedies aimed at ensuring EBS complies with
the existing License Agreement. The License Agreement was
originally between LightLake Therapeutics Inc. and Adapt Pharma
Limited, which Opiant and EBS are successors to, respectively.
Financial Results for the Six Months Ended June 30,
2022
For the six months ended June 30, 2022, Opiant recorded
approximately $8.4 million of revenue, compared to $17.6
million during the corresponding period of 2021. For the six months
ended June 30, 2022, Opiant recognized $4.5 million of revenue from
its license agreement with EBS and $3.8 million from grant and
contract revenue. This compares to $13.6 million and $4.0 million,
respectively, for the same period in 2021. First half 2022 sales of
NARCAN® were approximately $194.6 million, as reported by
EBS.
For the six months ended June 30, 2022, G&A expenses
were approximately $8.3 million, compared to $5.4 million in
2021. Personnel and non-cash stock-based compensation increased by
$2.4 million along with a net increase of approximately $0.5
million associated with legal and other fees for the six months
ended June 30, 2022, compared to the six months ended June 30,
2021.
R&D expenses during the six months ended June 30, 2022,
increased by $9.5 million to $16.7 million, compared to
$7.2 million for the six months ended June 30, 2021. The
increase was primarily due to increased activity by $7.8 million on
our lead product candidate, OPNT003, nasal nalmefene, and to
personnel and non-cash stock-based compensation expense of $1.7
million.
S&M expenses for the six months ended June 30, 2022,
increased by $3.5 million to $5.5 million from $2.0 million for the
six months ended June 30, 2021. Personnel and non-cash stock-based
compensation expense increased by $2.0 million, and external third
party spend related to pre-commercial activities increased by $1.5
million.
Royalty expense for the six months ended June 30, 2022, was
approximately $0.9 million, compared to approximately $3.1 million
for the comparable period of 2021. The decrease of
$2.2 million is attributable to the decrease in net revenue
recorded from sales of NARCAN® by EBS.
Net loss for the six months ended June 30, 2022, was
approximately $24.0 million, or a loss of $4.74 per basic
and diluted share, compared to net loss of
approximately $1.2 million, or a loss of $0.27 per basic
and diluted share, for the comparable period of 2021.
As of June 30, 2022, Opiant had $40.2 million in cash and
cash equivalents.
In August, Opiant announced that the Biomedical Advanced
Research and Development Authority (BARDA) has awarded an
additional approximately $2.1 million to support OPNT003,
nasal nalmefene. The funding is primarily directed toward the
preparation and filing of a New Drug Application for OPNT003 to the
Food and Drug Administration.
Awards from BARDA for up to $10.8 million, combined with
a $7.4 million grant Opiant received from
the National Institute on Drug Abuse, support the clinical
development and U.S. regulatory submission of OPNT003. The contract
with BARDA will also potentially allow for the development of
OPNT003 as a medical countermeasure in a chemical attack using
weaponized synthetic opioids as well as reverse opioid overdoses in
the community.
BARDA is part of the Office of the Assistant Secretary
for Preparedness and Response within the U.S. Department of
Health and Human Services. This project has been funded in
whole or 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 11th 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: |
13730815 |
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. 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 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, submit a New Drug Application in the second half of
2022. 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 comparable 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 Form 10-K for the year
ended December 31, 2021, and our Form 10-Q for the quarter
ended June 30, 2022, filed with the Securities and Exchange
Commission on March 4, 2022, and August 11, 2022,
respectively, 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 June
30 |
|
As of
December 31, |
|
|
|
2022 |
|
2021 |
Assets |
(unaudited) |
|
|
|
Current Assets |
|
|
|
|
|
Cash & cash equivalents |
$ |
40,173 |
|
|
$ |
37,854 |
|
|
|
Marketable
securities |
|
- |
|
|
$ |
15,015 |
|
|
|
Accounts
receivable |
|
2,336 |
|
|
|
13,327 |
|
|
|
Unbilled
receivable |
|
1,637 |
|
|
|
- |
|
|
|
Prepaid and
other current assets |
|
3,612 |
|
|
|
2,963 |
|
|
|
Total
Current Assets |
|
47,758 |
|
|
|
69,159 |
|
|
|
|
|
|
|
|
Other Assets |
|
|
|
|
|
Property and
equipment, net |
|
71 |
|
|
|
78 |
|
|
|
Right of use
assets - operating leases |
|
733 |
|
|
|
1,000 |
|
|
|
Patents and
patent applications, net |
|
11 |
|
|
|
12 |
|
|
|
Other
non-current assets |
|
251 |
|
|
|
179 |
|
|
|
Total
Assets |
$ |
48,824 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current Liabilities |
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
3,102 |
|
|
$ |
3,370 |
|
|
|
Accrued
salaries & wages |
|
1,226 |
|
|
|
202 |
|
|
|
Royalty
payable |
|
440 |
|
|
|
2,920 |
|
|
|
Deferred
revenue |
|
- |
|
|
|
17 |
|
|
|
Operating
leases |
|
227 |
|
|
|
338 |
|
|
|
Total
Current Liabilities |
|
4,995 |
|
|
|
6,847 |
|
|
Long-Term Liabilities |
|
|
|
|
|
Operating
leases - long term |
|
523 |
|
|
|
673 |
|
|
|
Convertible
debt - net of unamortized discount |
|
13,710 |
|
|
|
16,069 |
|
|
|
Total
Long-Term Liabilities |
|
14,233 |
|
|
|
16,742 |
|
|
|
Total
Liabilities |
|
19,228 |
|
|
|
23,589 |
|
|
Stockholders' equity |
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares |
|
|
|
|
|
authorized,
5,122,575 and 4,909,846 shares |
|
|
|
|
|
issued and
outstanding at June 30, 2022 and |
|
|
|
|
|
December 31,
2021, respectively |
|
5 |
|
|
|
4 |
|
|
Additional paid-in-capital |
|
115,439 |
|
|
|
108,570 |
|
|
Accumulated other comprehensive loss |
|
(243 |
) |
|
|
(55 |
) |
|
Accumulated deficit |
|
(85,605 |
) |
|
|
(61,680 |
) |
|
|
Total
stockholders' equity |
|
29,596 |
|
|
|
46,839 |
|
|
|
Total
liabilities and stockholders' equity |
$ |
48,824 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
Opiant
Pharmaceuticals Inc. |
Condensed
Consolidated Statements of Operations |
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Three months
ended |
|
Six months
ended |
|
Six months
ended |
|
|
|
June 30 |
|
June 30 |
|
June 30 |
|
June 30 |
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
Revenues |
|
|
|
|
|
|
|
|
Royalty revenue |
$ |
2,326 |
|
|
$ |
9,314 |
|
|
$ |
4,520 |
|
|
$ |
13,648 |
|
|
Grant and contract revenue |
|
1,568 |
|
|
|
1,945 |
|
|
|
3,845 |
|
|
|
3,998 |
|
|
|
Total Revenue |
|
3,894 |
|
|
|
11,259 |
|
|
|
8,365 |
|
|
|
17,646 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
General and administrative |
|
4,011 |
|
|
|
2,733 |
|
|
|
8,343 |
|
|
|
5,380 |
|
|
Research and development |
|
7,916 |
|
|
|
3,150 |
|
|
|
16,739 |
|
|
|
7,238 |
|
|
Sales & marketing |
|
2,816 |
|
|
|
1,023 |
|
|
|
5,493 |
|
|
|
2,020 |
|
|
Royalty expense |
|
517 |
|
|
|
2,107 |
|
|
|
943 |
|
|
|
3,086 |
|
|
|
Total
expenses |
|
15,260 |
|
|
|
9,013 |
|
|
|
31,518 |
|
|
|
17,724 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
(11,366 |
) |
|
|
2,246 |
|
|
|
(23,153 |
) |
|
|
(78 |
) |
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Interest income |
|
63 |
|
|
|
4 |
|
|
|
68 |
|
|
|
7 |
|
|
Interest expense |
|
(401 |
) |
|
|
(542 |
) |
|
|
(822 |
) |
|
|
(1,079 |
) |
|
Loss on foreign exchange |
|
|
|
(24 |
) |
|
|
16 |
|
|
|
(10 |
) |
|
|
Total other
income (expense) |
|
(338 |
) |
|
|
(562 |
) |
|
|
(738 |
) |
|
|
(1,082 |
) |
Income (loss) before provision for income taxes |
|
(11,704 |
) |
|
|
1,684 |
|
|
|
(23,891 |
) |
|
|
(1,160 |
) |
|
Income tax expense |
|
(33 |
) |
|
|
- |
|
|
|
(33 |
) |
|
|
- |
|
Net income (loss) |
$ |
(11,737 |
) |
|
$ |
1,684 |
|
|
$ |
(23,924 |
) |
|
$ |
(1,160 |
) |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Foreign currency translationadjustment |
|
(161 |
) |
|
|
(5 |
) |
|
|
(188 |
) |
|
|
8 |
|
Comprehensive income (loss) |
$ |
(11,898 |
) |
|
$ |
1,679 |
|
|
$ |
(24,112 |
) |
|
$ |
(1,152 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share |
|
|
|
|
|
|
|
|
Basic |
$ |
(2.31 |
) |
|
$ |
0.39 |
|
|
$ |
(4.74 |
) |
|
$ |
(0.27 |
) |
|
Diluted |
$ |
(2.31 |
) |
|
$ |
0.31 |
|
|
$ |
(4.74 |
) |
|
$ |
(0.27 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
5,087,647 |
|
|
|
4,332,601 |
|
|
|
5,051,814 |
|
|
|
4,308,027 |
|
|
Diluted |
|
5,087,647 |
|
|
|
5,427,831 |
|
|
|
5,051,814 |
|
|
|
4,308,027 |
|
|
|
|
|
|
|
|
|
|
|
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