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 nine months ended September 30, 2022. Recent
highlights include:
Finance Update
- Opiant and Emergent Biosolutions Inc. (EBS) settle legal
dispute over royalties paid on NARCAN® Nasal Spray. The settlement
includes a one-time payment, termination of the license agreement,
and an exclusive license relating to NARCAN® Nasal Spray to
EBS
- No royalty revenue recorded as license agreement with EBS has
been terminated
- Approximately $35.4 million in cash and cash equivalents, as of
September 30, 2022
Pipeline Update
- Completion of rolling New Drug Application (NDA) submission for
OPNT003, nasal nalmefene, for opioid overdose on track in Q4
2022
- Completed enrollment in the Phase 2 study for OPNT002, nasal
naltrexone, for Alcohol Use Disorder (AUD), and on track to report
topline results in mid-2023
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“We are pleased with our progress during the third quarter
towards completion of our NDA submission for OPNT003 and
preparations to support a potential launch next year. Our agreement
with Emergent Biosolutions to buy out the royalty for
NARCAN® Nasal Spray underscores our steadfast
commitment to the promise of OPNT003 and provides additional
and non-dilutive financial flexibility as we advance towards
commercialization. We also achieved the completion of
enrollment in our Phase 2 clinical trial for alcohol use
disorder.”
Settlement with Emergent Biosolutions, Inc. regarding
ongoing legal dispute of the royalty on
NARCAN® Nasal Spray:
Opiant entered into a settlement with Emergent Biosolutions Inc.
(EBS) resolving a legal dispute with EBS over its royalty
obligations to Opiant for NARCAN® Nasal Spray. Under the
settlement, EBS will make a one-time cash payment of $25
million to Opiant, which also includes the 10% owned by SWK
Holding, Inc., to terminate its license agreement with Opiant and
in exchange for the worldwide and exclusive license for NARCAN®
Nasal Spray, and licensed patents and know-how.
Financial Results for the Three Months Ended September
30, 2022
For the three months ended September 30, 2022, Opiant
recorded $0.2 million of revenue, compared to $16.3 million for the
three months ended September 30, 2021. The revenue this
quarter was from our contract with the Biomedical Advanced Research
and Development Authority (BARDA)1. Opiant recorded no royalty
revenue from its license agreement with EBS, since it has been
terminated. For the comparable three months ended
September 30, 2021, Opiant recorded $14 million of revenue
from its license agreement with EBS and $2.3 million from
grant and contract revenue.
For the three months ended September 30, 2022, general and
administrative (G&A) expenses decreased by $0.3 million to $3.1
million from $3.4 million for the three months ended
September 30, 2021. Our fees associated with net sales of
NARCAN® by EBS decreased by approximately $0.5 million, partially
offset by increased personnel and related expense including
stock-based compensation of $0.1 million and increased legal fees
of $0.1 million for the three months ended September 30, 2022,
compared to the three months ended September 30, 2021.
Research and development (R&D) expenses decreased by $0.8
million to $4.1 million, from $4.9 million for the three
months ended September 30, 2021. External development expense
decreased by $1.1 million primarily due to decreased activity on
our lead product candidate, OPNT003, nasal nalmefene, for opioid
overdose reversal, which was partially offset by an increase in
personnel and related expense including stock-based compensation of
$0.3 million.
Sales and marketing (S&M) expenses for the three months
ended September 30, 2022, increased by $1.5 million to $2.6 million
from $1.1 million for the three months ended
September 30, 2021. Personnel and related expense including
stock-based compensation increased by $0.4 million and external
third-party expenses related to pre-commercial activities increased
by $1.1 million.
Opiant did not report royalty expenses for the three months
ended September 30, 2022. Opiant recognized $3.1 million
for the three months ended September 30, 2021. The decrease of
$3.1 million is attributable to there being no royalty revenue
recorded from net sales of NARCAN® Nasal Spray by EBS during the
quarter ended September 30, 2022.
During the three months ended September 30, 2022, interest
expense was $0.4 million compared to $0.5 million during
the three months ended September 30, 2021. Interest expense is
all related to Opiant’s convertible debt.
Net loss for the three months ended September 30, 2022, was
approximately $10 million, or a loss of $1.93 per basic
share and diluted share, compared to net income of
approximately $3.4 million, or $0.77 per basic and $0.56
per diluted share, for the comparable period of 2021.
Financial Results for the Nine Months Ended September
30, 2022
For the nine months ended September 30, 2022, Opiant
recorded approximately $8.5 million of revenue, compared to
$34 million during the corresponding period of 2021. For the nine
months ended September 30, 2022, Opiant recognized $4.5
million of revenue from its license agreement with EBS and $4
million from grant and contract revenue. This compares to $27.7
million and $6.3 million, respectively, for the same period in
2021.
For the nine months ended September 30, 2022, G&A
expenses increased by $2.6 million to approximately $11.4 million
during the nine months ended September 30, 2022, compared to $8.8
million for the nine months ended September 30, 2021. Personnel and
related expense including stock-based compensation increased by
$2.5 million, and legal and other fees increased by $0.1
million.
R&D expenses during the nine months ended September 30,
2022, increased by $8.8 million to $20.9 million,
compared to $12.1 million for the nine months ended
September 30, 2021. External development expense increased by
$6.7 million primarily due to increased activity on OPNT003, nasal
nalmefene, and personnel and related expense, including stock-based
compensation increased by $2.1 million.
S&M expenses for the nine months ended September 30,
2022, increased by $5.0 million to $8.1 million from $3.1 million
for the nine months ended September 30, 2021. Personnel and
related expense including stock-based compensation increased by
$2.4 million, and external third-party expenses related to
pre-commercial activities increased by $2.6 million.
Royalty expenses were $0.9 million and $6.1 million during the
nine months ended September 30, 2022, and 2021, respectively.
The decrease of $5.2 million is attributable to the decrease
in net royalty revenue recorded from sales of NARCAN® Nasal Spray
by EBS.
During the nine months ended September 30, 2022, interest
income was $227.8 thousand compared to interest income of
$10.3 thousand for the nine months ended September 30,
2021, which primarily resulted from an increased rate of return on
Opiant’s invested cash balances.
During the nine months ended September 30, 2022, interest
expense was approximately $1.2 million compared to $1.6 million
during the nine months ended September 30, 2021. Interest
expense is all related to Opiant’s convertible debt.
Net loss for the nine months ended September 30, 2022, was
approximately $33.8 million, or a loss of $6.66 per basic
and diluted share, compared to net profit of
approximately $2.3 million, or a gain of $0.52 per basic
and $0.41 per diluted share, for the comparable period of
2021.
As of September 30, 2022, Opiant had $35.4 million in cash
and cash equivalents.
About Opiant Pharmaceuticals, Inc.Opiant
Pharmaceuticals, Inc., 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
- BARDA is part of the Administration for Strategic
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; Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
contract number HHSO100201800029C.
Opiant
Pharmaceuticals Inc. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(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 |
|
|
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
Revenues |
|
|
|
|
|
|
|
|
|
|
Royalty revenue |
|
|
$ |
- |
|
|
$ |
14,041 |
|
|
$ |
4,519 |
|
|
$ |
27,689 |
|
|
Grant and contract revenue |
|
|
|
174 |
|
|
|
2,298 |
|
|
|
4,019 |
|
|
|
6,297 |
|
|
|
Total Revenue |
|
|
|
174 |
|
|
|
16,339 |
|
|
|
8,538 |
|
|
|
33,986 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
3,073 |
|
|
|
3,379 |
|
|
|
11,416 |
|
|
|
8,759 |
|
|
Research and development |
|
|
|
4,134 |
|
|
|
4,881 |
|
|
|
20,873 |
|
|
|
12,119 |
|
|
Sales & marketing |
|
|
|
2,597 |
|
|
|
1,060 |
|
|
|
8,089 |
|
|
|
3,080 |
|
|
Royalty expense |
|
|
|
- |
|
|
|
3,059 |
|
|
|
943 |
|
|
|
6,145 |
|
|
|
Total
expenses |
|
|
|
9,804 |
|
|
|
12,379 |
|
|
|
41,321 |
|
|
|
30,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
|
(9,630 |
) |
|
|
3,960 |
|
|
|
(32,783 |
) |
|
|
3,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
160 |
|
|
|
4 |
|
|
|
228 |
|
|
|
10 |
|
|
Interest expense |
|
|
|
(391 |
) |
|
|
(547 |
) |
|
|
(1,213 |
) |
|
|
(1,626 |
) |
|
Loss on sale of assets |
|
|
|
(49 |
) |
|
|
- |
|
|
|
(49 |
) |
|
|
- |
|
|
Gain (loss) on foreign exchange |
|
|
|
2 |
|
|
|
- |
|
|
|
18 |
|
|
|
(10 |
) |
|
|
Total other
income (expense) |
|
|
|
(278 |
) |
|
|
(543 |
) |
|
|
(1,016 |
) |
|
|
(1,626 |
) |
Income (loss) before income taxes |
|
|
|
(9,908 |
) |
|
|
3,417 |
|
|
|
(33,799 |
) |
|
|
2,257 |
|
|
Income tax (expense) |
|
|
|
(9 |
) |
|
|
- |
|
|
|
(41 |
) |
|
|
- |
|
Net income (loss) |
|
|
$ |
(9,917 |
) |
|
$ |
3,417 |
|
|
$ |
(33,840 |
) |
|
$ |
2,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(5 |
) |
|
|
(8 |
) |
|
|
(193 |
) |
|
|
- |
|
Comprehensive income (loss) |
|
|
$ |
(9,922 |
) |
|
$ |
3,409 |
|
|
$ |
(34,033 |
) |
|
$ |
2,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share |
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
$ |
(1.93 |
) |
|
$ |
0.77 |
|
|
$ |
(6.66 |
) |
|
$ |
0.52 |
|
|
Diluted |
|
|
$ |
(1.93 |
) |
|
$ |
0.56 |
|
|
$ |
(6.66 |
) |
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
5,138,274 |
|
|
|
4,462,236 |
|
|
|
5,083,222 |
|
|
|
4,359,759 |
|
|
Diluted |
|
|
|
5,138,274 |
|
|
|
6,065,044 |
|
|
|
5,083,222 |
|
|
|
5,565,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Opiant
Pharmaceuticals, Inc. |
Condensed
Consolidated Balance Sheets |
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
September 30, |
As of
December 31, |
|
|
|
|
|
2022 |
|
2021 |
Assets |
|
|
(unaudited) |
|
|
|
Current Assets |
|
|
|
|
|
|
|
Cash & cash equivalents |
|
|
$ |
35,376 |
|
|
$ |
37,854 |
|
|
|
Marketable
securities |
|
|
|
- |
|
|
|
15,015 |
|
|
|
Accounts
receivable |
|
|
|
41 |
|
|
|
13,327 |
|
|
|
Prepaid and
other current assets |
|
|
|
3,131 |
|
|
|
2,963 |
|
|
|
Total Current Assets |
|
|
|
38,548 |
|
|
|
69,159 |
|
|
|
|
|
|
|
|
|
|
Other Assets |
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
|
418 |
|
|
|
78 |
|
|
|
Right of use
assets - operating leases |
|
|
|
2,739 |
|
|
|
1,000 |
|
|
|
Patents and
patent applications, net |
|
|
|
11 |
|
|
|
12 |
|
|
|
Other
non-current assets |
|
|
|
234 |
|
|
|
179 |
|
|
|
Total Assets |
|
|
$ |
41,950 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
|
$ |
3,113 |
|
|
$ |
3,370 |
|
|
|
Accrued
salaries & wages |
|
|
|
1,821 |
|
|
|
202 |
|
|
|
Royalty
payable |
|
|
|
- |
|
|
|
2,920 |
|
|
|
Deferred
revenue |
|
|
|
- |
|
|
|
17 |
|
|
|
Operating
leases |
|
|
|
669 |
|
|
|
338 |
|
|
|
Convertible
debt - net of unamortized discount |
|
|
|
1,437 |
|
|
|
- |
|
|
|
Total Current Liabilities |
|
|
|
7,040 |
|
|
|
6,847 |
|
|
Long-Term Liabilities |
|
|
|
|
|
|
|
Operating
leases - long term |
|
|
|
2,084 |
|
|
|
673 |
|
|
|
Convertible
debt - net of unamortized discount |
|
|
|
12,324 |
|
|
|
16,069 |
|
|
|
Total Long-Term Liabilities |
|
|
|
14,408 |
|
|
|
16,742 |
|
|
|
Total Liabilities |
|
|
|
21,448 |
|
|
|
23,589 |
|
|
Stockholders' equity |
|
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares |
|
|
|
|
|
|
authorized,
5,164,951 and 4,909,846 shares |
|
|
|
|
|
|
|
issued and outstanding at September 30, 2022 and |
|
|
|
|
|
|
December 31,
2021, respectively |
|
|
|
5 |
|
|
|
4 |
|
|
Additional paid-in-capital |
|
|
|
116,266 |
|
|
|
108,570 |
|
|
Accumulated other comprehensive loss |
|
|
|
(248 |
) |
|
|
(55 |
) |
|
Accumulated deficit |
|
|
|
(95,521 |
) |
|
|
(61,680 |
) |
|
|
Total stockholders' equity |
|
|
|
20,502 |
|
|
|
46,839 |
|
|
|
Total liabilities and stockholders' equity |
|
|
$ |
41,950 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
|
|
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