Vitaros U.S. NDA
Re-Submission Remains on Track for Third Quarter 2017
Vitaros
Drug-Device Human Factor Studies Underway
Operations Funded
Through the Third Quarter of 2018
Conference Call /
Webcast Today, May 11, 2017 at 4:30 p.m. ET
SAN DIEGO, May 11, 2017 (GLOBE
NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology, today reported financial results for the first
quarter of 2017 and provided a corporate update on its priorities
for the year.
"In the first quarter of this
year, we continued to execute on our strategy by creating a more
focused and capital efficient organization with the potential to
deliver on multiple regulatory, business development and commercial
milestones over the next twelve months," stated Richard W. Pascoe,
Chief Executive Officer. "More recently we have significantly
improved our financial outlook through a combination of
fundraising, venture debt retirement, and expense reduction
resulting in a balance sheet that is expected to fund our current
operating plan through the third quarter of 2018. Finally, we
remain on track to re-submit the Vitaros NDA in the third quarter
of this year with an anticipated approval decision in the first
half of 2018."
Recent
Highlights
Apricus continues to execute on
its corporate strategy as highlighted below:
Vitaros(TM) (alprostadil)
- Continued implementation of the U.S.
regulatory approval strategy to address issues raised by the FDA in
the original Vitaros NDA submission. Specifically, all
safety, chemistry, manufacturing and control (CMC) related issues
raised in the original Non-Approvable Letter will be addressed in
the re-submission. In addition, the FDA has determined that
the Vitaros product will be considered a drug-device combination
product and as such, Apricus has confirmed the necessary device
engineering and compliance requirements, including human factor
testing, and those studies are currently underway in accordance
with the applicable FDA guidance; and
- Sold Vitaros ex-US rights and assets
to Ferring International in March 2017 for approximately $12.7
million, including an $11.5 million upfront payment received at
closing, a $700,000 inventory payment received last month, and
$500,000 in transition services that Apricus is eligible to receive
over two quarters, subject to certain limitations, and eliminated
certain future ex-US Vitaros liabilities.
RayVa(TM) (alprostadil)
- Initiated a partnering process to
secure a global or regional RayVa partnership prior to initiating a
Phase 2b clinical study; and
- Continued to refine the clinical
trial protocol and clinical trial material formulation needed to
initiate a Phase 2b study.
Corporate/Financial
- Closed on an underwritten public
offering of common stock and warrants in April 2017 for gross
proceeds of approximately $7.0 million;
- Paid $6.6 million to retire our
remaining venture debt with Oxford Finance and Silicon Valley
Bank;
- Reduced our monthly cash burn to
approximately $500,000; and
- Regained compliance with all
criteria for continued listing on The NASDAQ Capital Market,
including the minimum stockholders' equity requirement.
First
Quarter Financial Results
Net income for the quarter ended
March 31, 2017 was $8.1 million, or basic earnings per share
of $1.04, compared to a net loss of $2.5 million, or basic loss per
share of $0.46, for the first quarter of 2016. Net income during
the first quarter of 2017 was primarily due to the $11.8 million
gain recorded in Q1 2017 for the sale of our ex-U.S. Vitaros rights
and assets to Ferring. For both periods presented, financial
statement activity related to our ex-U.S. Vitaros business has been
presented as discontinued operations.
As of April 26, 2017, the
Company's cash totaled $10.6 million, compared to $2.1 million as
of December 31, 2016.
Conference
Call Details
Apricus will host a live
conference call and webcast today at 4:30 p.m. Eastern Time to
discuss the Company's financial results and provide a corporate
update. To participate by telephone, please dial (855) 780-7196
(Domestic) or (631) 485-4867 (International). The conference
ID number is 18008306. The live and archived audio webcast can be
accessed through the Investors Relations' section of the Company's
website at www.apricusbio.com. Please log in approximately
five to ten minutes before the event to ensure a timely connection.
The archived webcast will be available for 30 days following the
live call.
About
Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI)
is a biopharmaceutical company advancing innovative medicines in
urology and rheumatology. Apricus has two product candidates
currently in development. Vitaros is a product candidate in the
United States for the treatment of erectile dysfunction, which is
in-licensed from Warner Chilcott Company, Inc., now a subsidiary of
Allergan plc (Allergan). RayVa is our product candidate in Phase 2
development for the treatment of the circulatory disorder Raynaud's
phenomenon, secondary to scleroderma, for which we own worldwide
rights.
For further information on
Apricus, visit http://www.apricusbio.com.
Vitaros(TM) is Apricus'
trademark in the United States, which is pending registration and
subject to the agreement with Allergan. Vitaros® is a
registered trademark of Ferring International Center S.A. in
certain countries outside of the United States.
RayVa(TM) is Apricus' trademark, which is registered in
certain countries throughout the world and pending registration in
the United States.
Forward
Looking Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act, as amended. Statements in this
press release that are not purely historical are forward-looking
statements. Such forward-looking statements include, among other
things: Apricus' ability to transition its ex-U.S. assets and
rights related to Vitaros to Ferring and receive the transition
services payments from Ferring; the timing of regulatory submission
and approval of Vitaros in the United States, if any; Apricus'
development and partnering plans for RayVa; Apricus' plans to
reduce operating expenses and achieve profitability, including
projected 2017 cost savings; and Apricus' strategic objectives.
Actual results could differ from those projected in any
forward-looking statements due to a variety of reasons that are
outside the control of Apricus, including, but not limited to: the
risk that Apricus fails to provide the transition services as
required by the transition services agreement with Ferring; the
risk that the cost and other negative effects related to the
reduction of Apricus' workforce may be greater than anticipated;
the risk that Apricus may not realize the benefits expected from
cost control measures; competition in the erectile dysfunction
market and other markets in which Apricus operates; Apricus'
ability to obtain FDA and other requisite governmental approval for
Vitaros; Apricus' ability to further develop Vitaros, such as
delivery device improvements; Apricus' ability to carry out further
clinical studies for Vitaros, if required, as well as the timing
and success of the results of such studies; the failure to remain
in compliance with NASDAQ continued listing requirements which
could result in Apricus' common stock being delisted from the
exchange; Apricus' ability to retain and attract key personnel;
Apricus' ability to raise additional funding that it may need to
continue to pursue its commercial and business development plans;
Apricus' ability to secure a strategic partner for RayVa; and
market conditions. These forward-looking statements are made as of
the date of this press release, and Apricus assumes no obligation
to update the forward-looking statements, or to update the reasons
why actual results could differ from those projected in the
forward-looking statements. Readers are urged to read the risk
factors set forth in Apricus' most recent annual report on Form
10-K, subsequent quarterly reports filed on Form 10-Q, and other
filings made with the SEC. Copies of these reports are available
from the SEC's website at www.sec.gov or without charge
from Apricus.
(Financial Information to
Follow)
|
Selected Financial Information
Condensed Consolidated Statements of
Operations
(In thousands, except per share
amounts) |
|
|
|
Three Months Ended
March 31, |
|
|
2017 |
|
2016 |
Operating expense |
|
|
|
|
Research and development |
|
$ |
(412 |
) |
|
$ |
(2,602 |
) |
General and
administrative |
|
(1,441 |
) |
|
(2,224 |
) |
Total other (expense)
income |
|
(1,551 |
) |
|
2,312 |
|
Loss from
continuing operations |
|
(3,404 |
) |
|
(2,514 |
) |
Income from
discontinued operations |
|
11,477 |
|
|
9 |
|
Net income (loss) |
|
$ |
8,073 |
|
|
$ |
(2,505 |
) |
|
|
|
|
|
Earnings (loss) per share |
|
|
|
|
Basic |
|
$ |
1.04 |
|
|
$ |
(0.46 |
) |
Diluted |
|
$ |
1.04 |
|
|
$ |
(0.95 |
) |
Weighted average common shares
outstanding |
|
|
|
|
Basic |
|
7,737 |
|
|
5,505 |
|
Diluted |
|
7,737 |
|
|
5,602 |
|
|
Condensed Consolidated Balance Sheets
(In thousands) |
|
|
|
March 31,
2017 |
|
December 31,
2016 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Cash |
|
$ |
3,762 |
|
|
$ |
2,087 |
|
Other current assets |
|
181 |
|
|
177 |
|
Property and equipment,
net |
|
142 |
|
|
164 |
|
Other long term assets |
|
65 |
|
|
60 |
|
Assets of discontinued
operations |
|
$ |
1,203 |
|
|
$ |
2,212 |
|
Total
assets |
|
$ |
5,353 |
|
|
$ |
4,700 |
|
|
|
|
|
|
Liabilities and stockholders' equity
(deficit) |
|
|
|
|
Current liabilities |
|
$ |
1,768 |
|
|
$ |
2,536 |
|
Notes payable, net |
|
- |
|
|
6,650 |
|
Current liabilities of
discontinued operations |
|
822 |
|
|
2,108 |
|
Warrant liabilities |
|
1,854 |
|
|
846 |
|
Other long term
liabilities |
|
67 |
|
|
76 |
|
Stockholders' equity
(deficit) |
|
842 |
|
|
(7,516 |
) |
Total
liabilities and stockholders' equity (deficit) |
|
$ |
5,353 |
|
|
$ |
4,700 |
|