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 ended March 31, 2022, and provided a corporate
update. Recent highlights include:
Finance Update
- Q1 revenues of $4.5 million; $2.2 million of revenue was
attributable to the license agreement with Emergent BioSolutions,
Inc. (“EBS”) for the sale of NARCAN® Nasal Spray
- The royalty rate reduced in Q1 due to EBS applying the “Generic
Reduction Clause” contained in the License Agreement
- Well capitalized, with approximately $50.8 million in
cash, cash equivalents and marketable securities, as of March 31,
2022
Pipeline Update
- OPNT003, nasal nalmefene, for opioid overdose:
- Reported positive topline results from a pharmacodynamic (“PD”)
study for OPNT003, nasal nalmefene
- OPNT003 met the primary endpoint of non-inferiority, which was
designed to assess whether nasal nalmefene performed at least as
well as nasal naloxone
- OPNT003 produced, at the primary end point of five minutes, a
greater reversal in remifentanil-induced respiratory depression
that was nearly twice that produced by nasal naloxone
- Additional analyses of select secondary endpoints show that at
5 minutes after administration, nasal nalmefene achieved a reversal
of remifentanil-induced respiratory depression to values that were
within the 95% confidence interval (“CI”) of the minute ventilation
observed just prior to remifentanil infusion. This reversal was
maintained through 20 minutes. Nasal naloxone achieved a similar
reversal of minute ventilation only at 20 minutes
- Completion of the PD study concludes the planned clinical
development program for OPNT003
- On track to complete New Drug Application (“NDA”) for OPNT003
in H2 2022, following completion of recent pre-NDA meeting
- Commercial preparations continue to advance for a potential
commercial launch in 2023; Centers for Disease Control and
Prevention (“CDC”) provisional data confirms more than 80,000
people died of opioid overdose in 2021, a 16% increase over
2020
- OPNT002, nasal naltrexone, for Alcohol Use Disorder (“AUD”):
- Continued patient enrollment and dosing in Phase 2 study; data
expected in H1 2023
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“The latest CDC data have put a spotlight on the continued
worsening of the opioid crisis. The need for new safe and effective
opioid overdose reversal treatments is greater than ever, and at
Opiant we’ve made strong progress advancing the OPNT003, nasal
nalmefene, development program. The compelling results of the
recently completed PD study versus nasal naloxone add to the
significant body of clinical and non-clinical evidence
demonstrating the potential of our late-stage product candidate to
offer an important treatment option for opioid overdose. With the
planned clinical development program for OPNT003 now concluded, we
have met with the FDA, and feel we are well-positioned to submit
our NDA for OPNT003, which we anticipate occurring in the second
half of this year. On the commercial front, preparations continue
at pace. Beyond OPNT003, our robust pipeline also continues to
progress, as patient enrollment and dosing ramp up in our ongoing
Phase 2 study of OPNT002, nasal naltrexone, for alcohol use
disorder.”
David O’Toole, Chief Financial Officer of Opiant, said:
“From a capital resource perspective, we ended the first quarter
with approximately $51 million of cash and continue to
prudently manage our expenses, enabling us to execute on our key
commercial and R&D initiatives. We look forward to multiple
potentially value enhancing regulatory, commercial and clinical
catalysts in the quarters ahead.”
Financial Results for the First Quarter Ended March
31, 2022For the three months ended March 31, 2022,
Opiant recorded approximately $4.5 million in revenue,
compared to approximately $6.4 million during the
corresponding period of 2021. $2.2 million of revenue was
attributable to the license agreement with Emergent BioSolutions,
Inc., (“EBS”) for the sale of NARCAN® Nasal Spray, compared to
approximately $4.3 million in the same period of 2021.
Approximately $2.3 million came from grant and contract
revenue, compared to approximately $2.1 million in the same period
in 2021. First quarter 2022 sales of NARCAN® Nasal Spray were
approximately $93.1 million, as reported by EBS.
The decrease in royalty rate was due to EBS applying the
“Generic Reduction Clause,” which is provided for in the License
Agreement between Opiant and Adapt Pharma. Since the generic entry
of nasal naloxone into the U.S. marketplace in December of 2021, to
the extent the clause is rightfully triggered, EBS can reduce
royalties payable to Opiant to 2% for the quarter in the event U.S.
net sales decrease by greater than 30% during the quarter when
compared to the net NARCAN® sales in the quarter before the launch
of the generic. The clause states that this calculation is
completed separately each quarter, which means that the application
of the Generic Reduction Clause this quarter has no bearing on
whether it is triggered in the remaining quarters of 2022.
For the three months ended March 31, 2022, general and
administrative (“G&A”) expenses were approximately $4.4
million, as compared to approximately $2.6 million in the
comparable period in 2021. The $1.9 million increase was due to a
$1.2 million increase in employee costs, including stock-based
compensation and a $0.7 million increase in legal fees.
Research and development (“R&D”) expenses for the three
months ended March 31, 2022, were approximately $8.8 million,
as compared to approximately $4.1 million in the comparable period
in 2021. The $4.7 million increase was primarily due to expenses
associated with the completion of the clinical work for OPNT003.
Approximately $2.2 million of the increase was offset by
reimbursement by the contract with Biomedical Advanced Research and
Development Authority (“BARDA”).
Sales and marketing (“S&M”) expenses for the three months
ended March 31, 2022, were approximately $2.7 million for
pre-commercialization efforts related to OPNT003.
Royalty expense for the three months ended March 31, 2022, was
approximately $0.4 million and $1.0 million for the comparable
period of 2021. The $0.6 million decrease was due to decreased
royalty revenue from net sales of NARCAN® Nasal Spray.
Net loss for the three months ended March 31, 2022, was
approximately $12.2 million, or a loss of $2.43 per basic
and diluted share, compared to a net loss of
approximately $2.8 million, or loss of $0.66 per basic
and diluted share, for the comparable period of 2021.
As of March 31, 2022, Opiant had approximately $50.8
million in cash, cash equivalents, and marketable
securities.
The OPNT003 development program 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, May
10th 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: |
13728852 |
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, filed with the Securities and
Exchange Commission on March 4, 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. |
|
Condensed
Consolidated Statements of Operations |
|
(in
thousands, except shares and per share amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
|
|
|
|
March 31, |
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
Royalty revenue |
|
$ |
2,193 |
|
|
$ |
4,334 |
|
|
|
Grant and contract revenue |
|
|
2,277 |
|
|
|
2,053 |
|
|
|
|
Total
revenue |
|
|
4,470 |
|
|
|
6,387 |
|
|
Operating expenses |
|
|
|
|
|
|
General and administrative |
|
|
4,332 |
|
|
|
2,646 |
|
|
|
Research and development |
|
|
8,823 |
|
|
|
4,088 |
|
|
|
Sales and marketing |
|
|
2,677 |
|
|
|
998 |
|
|
|
Royalty expense |
|
|
426 |
|
|
|
979 |
|
|
|
|
Total
operating expenses |
|
|
16,258 |
|
|
|
8,711 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(11,788 |
) |
|
|
(2,324 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
Interest income |
|
|
5 |
|
|
|
3 |
|
|
|
Interest expense |
|
|
(421 |
) |
|
|
(537 |
) |
|
|
Gain on foreign exchange |
|
|
16 |
|
|
|
14 |
|
|
|
|
Total other
income (expense) |
|
|
(400 |
) |
|
|
(520 |
) |
|
Loss before income taxes |
|
|
(12,188 |
) |
|
|
(2,844 |
) |
|
Income tax expense |
|
|
- |
|
|
|
- |
|
|
Net loss |
|
$ |
(12,188 |
) |
|
$ |
(2,844 |
) |
|
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(27 |
) |
|
|
13 |
|
|
Total other comprehensive loss |
|
$ |
(12,215 |
) |
|
$ |
(2,831 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(2.43 |
) |
|
$ |
(0.66 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
Basic and Diluted |
|
|
5,015,262 |
|
|
|
4,282,923 |
|
|
|
|
|
|
|
|
|
|
Opiant Pharmaceuticals,
Inc. |
|
Condensed Consolidated Balance
Sheets |
(in thousands, except shares and per
share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March
31 |
|
As of
December 31, |
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Assets |
|
|
(unaudited) |
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash &
cash equivalents |
|
|
$ |
48,325 |
|
|
$ |
37,854 |
|
|
|
|
Marketable
securities |
|
|
|
2,500 |
|
|
$ |
15,015 |
|
|
|
|
Accounts
receivable |
|
|
|
4,454 |
|
|
|
13,327 |
|
|
|
|
Prepaid and
other current assets |
|
|
|
3,881 |
|
|
|
2,963 |
|
|
|
|
Total Current Assets |
|
|
|
59,160 |
|
|
|
69,159 |
|
|
|
|
|
|
|
|
|
|
|
|
Other Assets |
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
|
71 |
|
|
|
78 |
|
|
|
|
Right of use
assets - operating leases |
|
|
|
875 |
|
|
|
1,000 |
|
|
|
|
Patents and
patent applications, net |
|
|
|
11 |
|
|
|
12 |
|
|
|
|
Other
non-current assets |
|
|
|
202 |
|
|
|
179 |
|
|
|
|
Total Assets |
|
|
$ |
60,319 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
|
$ |
5,319 |
|
|
$ |
3,370 |
|
|
|
|
Accrued
salaries & wages |
|
|
|
760 |
|
|
|
202 |
|
|
|
|
Royalty
payable |
|
|
|
426 |
|
|
|
2,920 |
|
|
|
|
Deferred
revenue |
|
|
|
- |
|
|
|
17 |
|
|
|
|
Operating
leases |
|
|
|
283 |
|
|
|
338 |
|
|
|
|
Total Current Liabilities |
|
|
|
6,788 |
|
|
|
6,847 |
|
|
|
Long-Term Liabilities |
|
|
|
|
|
|
|
|
Operating
leases - long term |
|
|
|
608 |
|
|
|
673 |
|
|
|
|
Convertible
debt - net of unamortized discount |
|
|
|
13,660 |
|
|
|
16,069 |
|
|
|
|
Total Long-Term Liabilities |
|
|
|
14,268 |
|
|
|
16,742 |
|
|
|
|
Total
Liabilities |
|
|
|
21,056 |
|
|
|
23,589 |
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares |
|
|
|
|
|
|
|
authorized,
5,079,605 and 4,909,846 shares |
|
|
|
|
|
|
|
|
issued and
outstanding at March 31, 2022 and |
|
|
|
|
|
|
|
|
December 31,
2021, respectively |
|
|
|
5 |
|
|
|
4 |
|
|
|
Additional paid-in-capital |
|
|
|
113,208 |
|
|
|
108,570 |
|
|
|
Accumulated other comprehensive loss |
|
|
|
(82 |
) |
|
|
(55 |
) |
|
|
Accumulated deficit |
|
|
|
(73,868 |
) |
|
|
(61,680 |
) |
|
|
|
Total
stockholders' equity |
|
|
|
39,263 |
|
|
|
46,839 |
|
|
|
|
Total liabilities and stockholders'
equity |
|
|
$ |
60,319 |
|
|
$ |
70,428 |
|
|
|
|
|
|
|
|
|
|
|
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