Vitaros
Drug-Device Human Factor Studies Successfully Completed
Vitaros U.S. NDA
Final Draft Completed with Re-Submission Expected in Current
Quarter
Conference Call /
Webcast Today, August 2, 2017 at 4:30 p.m. ET
SAN DIEGO, Aug. 02, 2017 (GLOBE
NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology, today reported financial results for the second
quarter of 2017 and provided a corporate update on its priorities
for the remainder of the year.
"In the second quarter of this year,
we continued to execute on our strategy by creating a stable,
financially healthier organization focused on resubmission of the
Vitaros NDA," stated Richard W. Pascoe, Chief Executive Officer.
"We have improved our financial outlook through a combination of
fundraising and expense reduction, resulting in a balance sheet
that is expected to fund our current operating plan through the
third quarter of 2018. Importantly, we have completed the
final draft of the Vitaros NDA and we expect to re-submit the
Vitaros NDA this quarter with an anticipated FDA approval decision
in the first quarter of 2018. For the remainder of 2017, we
will focus on working with the FDA regarding the Vitaros NDA,
maintaining a productive dialogue with Allergan regarding the
commercial potential for Vitaros in the United States, securing a
development partner for RayVa, and continuing to diligently manage
our corporate resources."
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, Apricus has confirmed the
necessary drug-device engineering and compliance requirements,
including human factor testing, and those studies are now complete;
and
- Continued to ensure a smooth
transition of the Vitaros ex-US rights and assets to Ferring
International. Under the agreement, Apricus has received
approximately $12.45 million to date, including an upfront payment
of $11.5 million, approximately $0.7 million for the delivery of
certain product-related inventory and $0.25 million related to
transition services. Apricus is eligible to receive an
additional $0.25 million payment related to transition services,
subject to certain limitations, during the third quarter of
2017.
RayVa(TM) (alprostadil)
- Continued a partnering process to
secure a global or regional RayVa partnership prior to initiating a
Phase 2b clinical study.
Corporate/Financial
- Closed on an underwritten public
offering of common stock and warrants for gross proceeds of
approximately $7.0 million; and
- Regained compliance with all
criteria for continued listing on The NASDAQ Capital Market.
Second Quarter
and Year-to-Date Financial Results
Net loss for the quarter ended
June 30, 2017 was $1.5 million, or loss per share of $0.13,
compared to a net loss of $3.3 million, or loss per share of $0.54,
for the second quarter of 2016. Net loss during the second quarter
of 2017 was primarily due to expenses related to the preparation of
our resubmission of the Vitaros NDA and other general and
administrative expenses.
Net income for the six months ended
June 30, 2017 was $6.6 million, or income per share of $0.69,
compared to a net loss of $5.8 million, or loss per share of $1.00,
for the second quarter of 2016. Net income during the six months
ended June 30, 2017 was primarily due to the $12.1 million gain
recorded for the sale of our ex-U.S. Vitaros rights and assets to
Ferring.
For all periods presented, financial
statement activity related to our ex-U.S. Vitaros business has been
presented as discontinued operations. As of June 30, 2017,
the Company's cash totaled $7.8 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
58725002. 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 second
transition services payment 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, 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
June 30, |
|
Six Months Ended
June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating expense |
|
|
|
|
|
|
|
Research and development |
$ |
(839 |
) |
|
$ |
(2,503 |
) |
|
$ |
(1,266 |
) |
|
$ |
(5,104 |
) |
General and
administrative |
(1,602 |
) |
|
(2,122 |
) |
|
(3,043 |
) |
|
(4,328 |
) |
Total other income
(expense) |
719 |
|
|
1,372 |
|
|
(832 |
) |
|
3,684 |
|
Loss from continuing
operations |
(1,722 |
) |
|
(3,253 |
) |
|
(5,141 |
) |
|
(5,748 |
) |
Income (loss) from
discontinued operations |
248 |
|
|
(85 |
) |
|
11,740 |
|
|
(95 |
) |
Net income (loss) |
$ |
(1,474 |
) |
|
$ |
(3,338 |
) |
|
$ |
6,599 |
|
|
$ |
(5,843 |
) |
|
|
|
|
|
|
|
|
Basic and diluted earnings
(loss) per share |
|
|
|
|
|
|
|
Continuing operations |
$ |
(0.15 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.98 |
) |
Discontinued operations |
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
1.23 |
|
|
$ |
(0.02 |
) |
Total earnings (loss) per
share |
$ |
(0.13 |
) |
|
$ |
(0.54 |
) |
|
$ |
0.69 |
|
|
$ |
(1.00 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding for basic and diluted earnings (loss) per share |
11,335 |
|
|
6,182 |
|
|
9,547 |
|
|
5,843 |
|
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
June 30,
2017 |
|
December 31,
2016 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash |
$ |
7,821 |
|
|
$ |
2,087 |
|
Other current assets |
322 |
|
|
177 |
|
Property and equipment,
net |
121 |
|
|
164 |
|
Other long term assets |
45 |
|
|
60 |
|
Assets of discontinued
operations |
$ |
506 |
|
|
$ |
2,212 |
|
Total
assets |
$ |
8,815 |
|
|
$ |
4,700 |
|
|
|
|
|
Liabilities and stockholders' equity
(deficit) |
|
|
|
Current liabilities |
$ |
1,513 |
|
|
$ |
2,536 |
|
Current liabilities of
discontinued operations |
331 |
|
|
2,108 |
|
Notes payable, net |
- |
|
|
6,650 |
|
Warrant liabilities |
339 |
|
|
846 |
|
Other long term
liabilities |
60 |
|
|
76 |
|
Stockholders' equity
(deficit) |
6,572 |
|
|
(7,516 |
) |
Total
liabilities and stockholders' equity (deficit) |
$ |
8,815 |
|
|
$ |
4,700 |
|