Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ:OPNT), a specialty
pharmaceutical company developing pharmacological treatments for
addictions, today reported financial results for the fiscal fourth
quarter and year ended July 31, 2017.
“I recently testified before the President's
Commission on Combating Drug Addiction and the Opioid Crisis, where
industry experts and advocates came together to discuss strategies
to combat and treat drug abuse, addiction and the opioid epidemic.
This gathering of experts further strengthened our resolve to
continue the advancement of our pipeline of addiction therapies,”
said Roger Crystal, M.D., Chief Executive Officer of Opiant.
“Fiscal 2017 was a transformational year for Opiant, marked by a
significant increase in sales of NARCAN® Nasal Spray. We expect
fiscal 2018 will be another exciting year, and we believe we are
well positioned to execute on our mission to develop novel
therapeutics that transform the lives of patients with
addictions.”
Fourth Quarter 2017 and Recent
Highlights
- Received an additional $3.75 million in funding from SWK
Funding LLC (“SWK”), which was triggered by surpassing $25.0
million of net sales of NARCAN® Nasal Spray (“NARCAN”) for the
first half of calendar 2017.
- Announced that shares of our common stock were approved for
listing on the Nasdaq Capital Market (“Nasdaq”).
- Strengthened the leadership team through the appointment of
David O’Toole as Chief Financial Officer.
- Announced a collaboration with Titan Pharmaceuticals to explore
development of a novel approach to the prevention of opioid relapse
and overdose in individuals with opioid use disorder.
- Generated encouraging Phase I data for OPNT002, in development
for the treatment of Alcohol Use Disorder (AUD).
- Licensed Aegis Therapeutics’ Intravail® drug delivery
technology, which can improve the absorption of drugs delivered
nasally.
- Had three additional patents issued for NARCAN® Nasal Spray in
the U.S. Food and Drug Administration (FDA) publication, Approved
Drug Products with Therapeutic Equivalence Evaluations, commonly
known as the Orange Book. There are now six Orange Book-listed
patents covering NARCAN®.
Expected Clinical
Goals
- Further advance OPNT002 for AUD in the second half of calendar
2017.
- Complete enrollment of patients in the OPNT001 Phase II Study
for Bulimia Nervosa by end of calendar Q2 2018.
- Further advance the pre-clinical development of Opiant’s heroin
vaccine candidate, which was licensed in October 2016 from the
Walter Reed Army Institute of Research and the National Institute
on Drug Abuse (NIDA).
Financial Results
Quarter ended July 31, 2017 compared to
quarter ended July 31, 2016
For the quarter ended July 31, 2017, Opiant
generated revenue of approximately $3.75 million, compared to
approximately $0.3 million in the corresponding period in 2016. The
increase was primarily due to the $3.75 million milestone payment
that was earned under the royalty monetization agreement with
SWK.
General and administrative expenses were
approximately $2.0 million in the quarter ended July 31, 2017,
compared to approximately $1.2 million in the corresponding period
in 2016. The increase was primarily due to compensation expense
from increased headcount, consulting expense and legal fees.
Research and development expenses were
approximately $1.3 million for the quarter ended July 31, 2017,
compared to approximately $0.2 million for the same period in 2016.
The increase was primarily due to compensation expense associated
with the hiring of our Chief Scientific Officer and additional
clinical trial personnel in our UK office.
Selling expenses were approximately $0.3 million
compared to approximately $16 thousand for the same period in
2016.
For the quarter ended July 31, 2017, Opiant
reported a net loss of approximately $0.3 million, or a net loss of
$0.17 per basic share and fully-diluted share, compared to a net
loss of approximately $1.1 million, or a net loss of $0.57 per
basic share and fully-diluted share, for the same period in
2016.
Year ended July 31, 2017 compared to
year ended July 31, 2016
For the year ended July 31, 2017, Opiant
generated revenue of approximately $18.4 million, compared to
approximately $9.9 million in the corresponding period in 2016. The
increase was primarily due to the $3.75 million milestone payment
that was earned in July 2017 and the $13.7 million received in
December of 2016 at closing under the royalty monetization
agreement with SWK.
General and administrative expenses were
approximately $6.5 million for the year ended July 31, 2017,
compared to approximately $14.5 million for the same period in
2016. The decrease was primarily due to the reduction in
stock based compensation expense.
Research and development expenses were
approximately $3.2 million for the year ended July 31, 2017
compared to approximately $2.8 million for the same period in 2016.
The increase was primarily due to compensation expense related to
the hiring of our Chief Scientific Officer and additional clinical
trial personnel in our UK office.
Selling expenses were approximately $1.7 million
for the year ended July 31, 2017, compared to approximately $0.3
million for the corresponding period in 2016. The increase
was primarily due to selling expenses associated with the royalty
monetization agreement with SWK.
For the year ended July 31, 2017, Opiant
reported a net profit of approximately $6.6 million, or $3.27 per
basic share and $2.94 per fully-diluted share, compared to a net
loss of approximately $7.8 million, or $4.09 per basic and
fully-diluted share, for the same period in 2016.
Opiant ended the fiscal year 2017 with cash and
cash equivalents of approximately $6.9 million. This cash balance
does not include the $3.75 million that was received in August
2017.
About Opiant Pharmaceuticals,
Inc.
Opiant Pharmaceuticals, Inc. is a specialty
pharmaceutical company developing pharmacological treatments for
addictions. NIDA, a division of the NIH, describes these disorders
as chronic relapsing brain diseases which burden society at both
the individual and community levels. With its innovative opioid
antagonist nasal delivery technology, Opiant is positioned to
become a leader in these treatment markets. Its first product,
NARCAN® Nasal Spray, is approved for marketing in the U.S. and
Canada by the company’s partner, Adapt Pharma Operations Limited.
For more information please visit: www.opiant.com.
Forward-Looking Statements
This 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. 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. 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.
[Financial tables to follow]
Opiant Pharmaceuticals,
Inc. |
Condensed Consolidated Balance
Sheets |
(in thousands, except shares and per share
amounts) |
(unaudited) |
|
As of July 31, |
|
As of July 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
Assets |
|
|
|
|
|
Current
Assets |
|
|
|
|
Cash
& Cash Equivalents |
$ |
6,873 |
|
|
$ |
1,481 |
|
|
|
Accounts
Receivable |
|
3,750 |
|
|
|
313 |
|
|
|
Prepaid
expenses and other current assets |
|
165 |
|
|
|
62 |
|
|
|
Total
Current Assets |
|
10,788 |
|
|
|
1,856 |
|
|
|
Long-term
Assets |
|
|
|
|
|
Computer
equipment, net |
|
3 |
|
|
|
7 |
|
|
|
Patents
and patent applications, net |
|
17 |
|
|
|
19 |
|
|
|
Total
Assets |
$ |
10,808 |
|
|
$ |
1,882 |
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
(deficit) |
|
|
|
|
Current
Liabilities |
|
|
|
|
Accounts
Payable |
$ |
2,212 |
|
|
$ |
141 |
|
|
|
Accrued
Compensation and other current liabilities |
|
1,701 |
|
|
|
3,681 |
|
|
|
Note
Payable |
|
- |
|
|
|
165 |
|
|
|
Deferred
revenue |
|
254 |
|
|
|
250 |
|
|
|
Total
Current Liabilities |
|
4,167 |
|
|
|
4,237 |
|
|
|
Long-Term
Liabilities |
|
|
|
|
|
|
Deferred
revenue |
|
2,307 |
|
|
|
2,350 |
|
|
|
Total
Long-Term Liabilities |
|
2,307 |
|
|
|
2,350 |
|
|
|
|
Total
Liabilities |
|
6,474 |
|
|
|
6,587 |
|
|
|
Stockholders' equity (deficit) |
|
|
|
|
|
Common stock, $0.001
par value, 200,000,000 shares authorized, 2,026,608 and 1,992,433
shares issued and outstanding at July 31, 2017 and July 31, 2016,
respectively |
|
2 |
|
|
|
2 |
|
|
|
Additional paid-in-capital |
|
58,937 |
|
|
|
56,478 |
|
|
|
Accumulated deficit |
|
(54,605 |
) |
|
|
(61,185 |
) |
|
|
Total
stockholders' equity (deficit) |
|
4,334 |
|
|
|
(4,705 |
) |
|
|
Total
liabilities and stockholders' equity (deficit) |
$ |
10,808 |
|
|
$ |
1,882 |
|
|
|
|
|
Opiant Pharmaceuticals Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except shares and per share
amounts) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Year Ended |
|
|
|
July 31, |
|
July
31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Royalty
& licensing revenue |
$ |
3,750 |
|
|
$ |
313 |
|
|
$ |
18,406 |
|
$ |
5,098 |
|
|
Treatment
investment income |
|
22 |
|
|
|
- |
|
|
|
40 |
|
|
4,800 |
|
|
|
Total Revenue |
|
3,772 |
|
|
|
313 |
|
|
|
18,446 |
|
|
9,898 |
|
Operating
Expenses |
|
|
|
|
|
|
|
|
General and
Administrative |
|
1,962 |
|
|
|
1,189 |
|
|
|
6,530 |
|
|
14,509 |
|
|
Research
and development |
|
1,282 |
|
|
|
158 |
|
|
|
3,172 |
|
|
2,809 |
|
|
Sales and
Marketing |
|
328 |
|
|
|
16 |
|
|
|
1,651 |
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
3,572 |
|
|
|
1,363 |
|
|
|
11,353 |
|
|
17,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss) |
|
200 |
|
|
|
(1,050 |
) |
|
|
7,093 |
|
|
(7,738 |
) |
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense) |
|
|
|
|
|
|
|
|
Interest
income (expense), net |
|
11 |
|
|
|
(1 |
) |
|
|
20 |
|
|
(12 |
) |
|
Income
(loss) on foreign exchange |
|
1 |
|
|
|
(39 |
) |
|
|
18 |
|
|
(64 |
) |
|
|
Total other income
(expense |
|
12 |
|
|
|
(40 |
) |
|
|
38 |
|
|
(76 |
) |
Income
(loss) before provision for income taxes |
$ |
212 |
|
|
$ |
(1,090 |
) |
|
$ |
7,131 |
|
$ |
(7,814 |
) |
Provision
for income taxes |
$ |
550 |
|
|
|
|
|
550 |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) |
$ |
(338 |
) |
|
$ |
(1,090 |
) |
|
|
6,581 |
|
|
(7,814 |
) |
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per common share |
|
|
|
|
|
|
|
|
Basic net
income (loss) per common share |
$ |
(0.17 |
) |
|
$ |
(0.57 |
) |
|
$ |
3.27 |
|
$ |
(4.09 |
) |
|
Diluted net
income (loss) per common share |
$ |
(0.17 |
) |
|
$ |
(0.57 |
) |
|
$ |
2.94 |
|
$ |
(4.09 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
2,026,608 |
|
|
|
1,910,489 |
|
|
|
2,014,540 |
|
|
1,910,489 |
|
|
Diluted |
|
2,026,608 |
|
|
|
1,910,489 |
|
|
|
2,235,851 |
|
|
1,910,489 |
|
|
|
|
|
|
|
|
|
|
|
CONTACT INFORMATION:
Corporate
Contact:Investor.relations@opiant.com
Media Contact:Casey
Myburgh
Ketchum Public
Relations
Casey.Myburgh@Ketchum.com
202-835-8876
Investor Contact:Sam MartinArgot
Partnerssam@argotpartners.com212-600-1902
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