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, 2021, and provided a corporate
update. Recent highlights include:
Pipeline and Corporate Update
- OPNT003, nasal nalmefene, for opioid overdose:
- Confirmatory pharmacokinetic (“PK”) study close to completing
enrollment and on track to report data in early Q3
- First subjects dosed in head-to-head clinical pharmacodynamic
("PD") study comparing the effectiveness of OPNT003, nasal
nalmefene, with nasal naloxone; data anticipated in the fourth
quarter
- Other drug development activities necessary for NDA filing on
track to deliver data by year-end
- The Center for Disease Control released provisional
data for the year ending September 2020:
- 66,813 overdose were caused by opioids (predicted)
- 80% or 53,877 opioid overse deaths (predicted) were linked to
illicit synthetic opioids, and particularly fentanyl
- Awarded third and final tranche of $1.8 million from the total
grant of approximately $7.4 million from the National Institute on
Drug Abuse (“NIDA”), part of the National Institutes of Health, to
support the development of OPNT003
- OPNT004, drinabant, for Acute Cannabinoid Overdose:
- Preclinical activities and formulation development on track to
support an IND for parenteral administration
- OPNT002, nasal naltrexone, for Alcohol Use Disorder:
- Start of Phase 2 study, which was paused due to the ongoing
COVID-19 pandemic, remains on pause; Company is assessing optimal
time to proceed
- Strengthened board of directors with the addition of seasoned
clinical development executive, Lorianne Masuoka, M.D., in March
2021
Financial Highlights
- Q1 revenues of $6.4 million driven by royalties from the sale
of NARCAN® Nasal Spray (“NARCAN®”)
- As of March 31, 2021, $50.6 million in cash, cash equivalents,
and marketable securities
Commenting, Roger Crystal, M.D., President and Chief Executive
Officer of Opiant, said:
“Opiant had a strong start to 2021, including the commencement
of our confirmatory PK and PD studies for OPNT003, nasal nalmefene,
for opioid overdose. Our comprehensive development of OPNT003 is
indicative of our firm commitment to delivering new medicines to
save lives from addictions and drug overdose and support public
health in the face of a worsening drug overdose crisis driven
primarily by opioids. We believe OPNT003 may be particularly
effective for the treatment of overdoses from synthetic opioids,
like fentanyl, which is the leading cause of drug overdose death in
America.”
David O’Toole, Chief Financial Officer of Opiant, said:
“We remain in a strong financial position to support our ongoing
drug development activities and clinical studies, as well as to
ramp up pre-commercial efforts for our lead program, OPNT003.”
First quarter 2021 resultsFor the three months
ended March 31, 2021, Opiant recorded approximately $6.4
million in revenue, compared to approximately $4.3
million during the corresponding period of 2020. For the three
months ended March 31, 2021, we recorded
approximately $4.3 million of revenue from our license
agreement with Emergent BioSolutions, Inc. (“EBS”) for the sale of
NARCAN®, compared to approximately $4.2 million in the
same period of 2020. First quarter 2021 sales of NARCAN® were
approximately $74.2 million, as reported by EBS.
For the three months ended March 31, 2021, general and
administrative expenses were approximately $2.6 million, the
same as the comparable period of 2020.
Research and development expenses for the three months ended
March 31, 2021, were approximately $4.1 million, as compared
to approximately $1.4 million in the comparable period in 2020.
External development expense increased by $2.6 million due to
increased activity on our lead product candidate, OPNT003 - Nasal
Nalmefene. In addition, personnel and related expense increased by
approximately $0.1 million during the three months ended March 31,
2021 compared to the three months ended March 31, 2020.
Sales and marketing expenses for the three months ended March
31, 2021, were approximately $1.0 million for pre-commercialization
efforts related to OPNT003, nasal nalmefene. Sales and marketing
expense during the three months ended March 31, 2020 was
approximately $1.1 million.
Royalty expense for the three months ended March 31, 2021, was
approximately $1 million, compared to $0.9 million for the
comparable period of 2020.
Net loss for the three months ended March 31, 2021, was
approximately $2.8 million, or a loss of $0.66 per basic
and diluted share, compared to net loss of
approximately $1.7 million, or a loss of $0.40 per basic
and diluted share, for the comparable period of 2020.
As of March 31, 2021, Opiant had $50.6 million in cash,
cash equivalents, and marketable securities. Current cash balance
does not include the full impact of the NIDA grant of
approximately $7.4 million or the Biomedical Advanced Research
and Development Authority contract of approximately $8.1
million.
Based on the mid-range of the full-year 2021 guidance for sales
of NARCAN® Nasal Spray provided by EBS, of $315 million, we
continue to expect full-year 2021 royalty revenue from the sale of
NARCAN® Nasal Spray of approximately $27.8 million. We also expect
to end 2021 with cash and cash equivalents of approximately $40
million, which will not include any receipt of additional tranches
of the convertible debt deal.
Conference
Call Details: |
Tuesday, May
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: |
13718590 |
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 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 March
31, |
|
As of
December 31, |
|
|
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
(unaudited) |
|
|
|
Current assets |
|
|
|
|
|
|
Cash &
cash Equivalents |
|
$ |
35,450 |
|
|
$ |
48,251 |
|
|
|
Marketable
securities |
|
|
12,598 |
|
|
|
- |
|
|
|
Accounts
receivable |
|
|
5,609 |
|
|
|
8,911 |
|
|
|
Prepaid
expenses and other current assets |
|
|
2,447 |
|
|
|
1,937 |
|
|
|
Total current assets |
|
|
56,104 |
|
|
|
59,099 |
|
|
Other assets |
|
|
|
|
|
|
Marketable
securities |
|
|
2,501 |
|
|
|
- |
|
|
|
Property and
equipment, net |
|
|
140 |
|
|
|
171 |
|
|
|
Right of use
assets - operating leases |
|
|
146 |
|
|
|
279 |
|
|
|
Patents and
patent applications, net |
|
|
12 |
|
|
|
13 |
|
|
|
Other
non-current assets |
|
|
- |
|
|
|
1,051 |
|
|
|
Total assets |
|
$ |
58,903 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
3,680 |
|
|
$ |
2,966 |
|
|
|
Accrued
salaries and wages |
|
|
481 |
|
|
|
909 |
|
|
|
Royalty
payable |
|
|
980 |
|
|
|
1,908 |
|
|
|
Deferred
revenue |
|
|
859 |
|
|
|
355 |
|
|
|
Operating
leases |
|
|
149 |
|
|
|
282 |
|
|
|
Total current liabilities |
|
|
6,149 |
|
|
|
6,420 |
|
|
Long-term liabilities |
|
|
|
|
|
|
Convertible
debt, net of unamortized discount |
|
|
18,769 |
|
|
|
18,701 |
|
|
|
Total long-term liabilities |
|
|
18,769 |
|
|
|
18,701 |
|
|
|
Total liabilities |
|
|
24,918 |
|
|
|
25,121 |
|
|
Stockholders' equity |
|
|
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized,
4,330,594 and 4,258,105 shares issued and outstanding at March
31, 2021 and December 31, 2020, respectively |
|
|
4 |
|
|
|
4 |
|
|
Additional paid-in-capital |
|
|
101,529 |
|
|
|
100,204 |
|
|
Accumulated other comprehensive loss |
|
|
(15 |
) |
|
|
(27 |
) |
|
Accumulated deficit |
|
|
(67,533 |
) |
|
|
(64,689 |
) |
|
|
Total
stockholders' equity |
|
|
33,985 |
|
|
|
35,492 |
|
|
|
Total liabilities and stockholders'
equity |
|
$ |
58,903 |
|
|
$ |
60,613 |
|
|
|
|
|
|
|
|
Opiant
Pharmaceuticals Inc. |
Condensed
Consolidated Statements of Operations |
(in
thousands, except shares and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Three months
ended |
|
|
|
|
|
March 31, |
|
March 31, |
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
Revenues |
|
|
|
|
|
|
Royalty revenue |
|
|
$ |
4,334 |
|
|
$ |
4,199 |
|
|
Grant and contract revenue |
|
|
|
2,053 |
|
|
|
84 |
|
|
|
Total
Revenue |
|
|
|
6,387 |
|
|
|
4,283 |
|
Operating expenses |
|
|
|
|
|
|
General and administrative |
|
|
|
2,646 |
|
|
|
2,573 |
|
|
Research and development |
|
|
|
4,088 |
|
|
|
1,421 |
|
|
Sales & marketing |
|
|
|
998 |
|
|
|
1,077 |
|
|
Royalty expense |
|
|
|
980 |
|
|
|
934 |
|
|
|
|
|
|
|
|
|
|
|
Total
expenses |
|
|
|
8,712 |
|
|
|
6,005 |
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
|
(2,325 |
) |
|
|
(1,722 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
Interest income |
|
|
|
3 |
|
|
|
76 |
|
|
Interest expense |
|
|
|
(537 |
) |
|
|
- |
|
|
Loss on foreign exchange |
|
|
|
14 |
|
|
|
- |
|
|
|
Total other
income (expense) |
|
|
|
(520 |
) |
|
|
76 |
|
Loss before provision for income taxes |
|
|
|
(2,845 |
) |
|
|
(1,646 |
) |
Income tax expense |
|
|
|
- |
|
|
|
39 |
|
Net loss |
|
|
$ |
(2,845 |
) |
|
$ |
(1,685 |
) |
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
13 |
|
|
|
(293 |
) |
Comprehensive loss |
|
|
$ |
(2,832 |
) |
|
$ |
(1,978 |
) |
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
Basic & Diluted |
|
|
$ |
(0.66 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
Basic & Diluted |
|
|
|
4,282,923 |
|
|
|
4,224,555 |
|
|
|
|
|
|
|
|
|
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