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Apricus Biosciences Provides Corporate Update and First Quarter Financial Results

Apricus Biosciences, Inc.
Press release

Apricus Biosciences Provides Corporate Update and First Quarter Financial

Vitaros® U.S. NDA Re-Submission on Schedule for 3Q 2016

SAN DIEGO, 2016-05-09 13:00 CEST (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 2016 and provided a corporate update on its
priorities for 2016. Apricus will hold a previously announced webcast this
morning at 8:00 am PDT with Edward D. Kim, M.D., a member of the Company’s
Scientific Advisory Board and a Vitaros® clinical investigator, to discuss the
Vitaros opportunity as part of the Company’s corporate activities concurrent
with the American Urological Association's 2016 Annual Meeting, May 6 - 10 in
San Diego. Please join the webcast at to view the
presentation slides or, to participate by telephone, dial (877) 841-3961
(Domestic) or (201) 689-8589 (International). The conference ID number is

“In March, we sharpened our focus on growth of the Vitaros brand, as we
streamlined our organization in an effort to align our corporate strategy and
our financial resources with the goal of achieving profitability in 2017,”
stated Richard W. Pascoe, Chief Executive Officer. “Importantly, we experienced
record Vitaros royalties in Europe in the first quarter of 2016 and we continue
to have a productive dialogue with the Food and Drug Administration (“FDA”)
regarding the Vitaros New Drug Application (“NDA”) resubmission content and
format. As such, we remain on track to resubmit the NDA for Vitaros U.S. in
the third quarter of 2016 with an approval decision expected after a six month
review period. Finally, we will continue to work closely with our partners to
grow Vitaros revenue by supporting additional regulatory approvals and
launches, licensing additional territories, and leveraging our existing
partnerships to help ensure Vitaros is actively commercialized in all approved

First Quarter Highlights and Recent Developments

Apricus recently updated its corporate goals to focus on increasing Vitaros’
value through the fostering and expansion of its commercial partnerships, in
the U.S. and globally, and strengthening the Company’s financial position.
First quarter and recent highlights include:

-- Closed on a $10 million registered direct offering with certain
institutional investors, including existing investors Sarissa Capital and
Aspire Capital;
-- Reported top-line Phase 2b data for fispemifene in symptomatic secondary
hypogonadism that failed to achieve statistical significance in key
clinical benefit endpoints and abandoned further clinical activities
surrounding fispemifene; and
-- Expanded the Company’s exclusive distribution agreement with Ferring
Pharmaceuticals to market Vitaros in the United Kingdom as part of the
Company’s ongoing initiative to consolidate Vitaros territories with
existing partners in an effort to maximize efficiencies and revenue.

2016 Priorities

Apricus is focused on achieving the following key strategic objectives:

Vitaros®* (alprostadil)

-- Continue implementation of the U.S. regulatory approval strategy to address
the safety and manufacturing issues raised by the FDA in the original
Vitaros NDA submission, with an NDA resubmission on target for the third
quarter of 2016;
-- Continue to support the Company’s ex-U.S. partners’ efforts to increase
revenue in countries where partners have launched Vitaros, seek solutions
to ensure that Vitaros is available to patients in every country where it
is approved but not currently marketed, support new commercial launches by
the Company’s partners and assist the Company’s partners in obtaining
additional regulatory approvals in their respective territories; and
-- Continue to generate the required data in 2016 to support delivery device
improvements and related regulatory submission(s) with a priority to
support the U.S. NDA resubmission of the refrigerated version of Vitaros.

RayVa™ (alprostadil)

-- Complete the formulation development for at-home dosing;
-- Finalize the Phase 2b study protocol;
-- Explore Orphan Drug Designation in the U.S. and EU; and
-- Explore global or regional partnerships prior to initiating the Phase 2b

First Quarter Financial Results

Revenue during the quarter ended March 31, 2016 was $0.6 million, compared to
revenue of $0.5 million during the first quarter of 2015. Revenue during the
quarter ended March 31, 2016 was comprised of $0.4 million in royalty revenues,
an increase of $0.3 million or 317% over the quarter ended March 31, 2015.
Revenue during the quarter ended March 31, 2015 included $0.4 million in
license fee revenue related to the expansion of the Company’s license agreement
with Sandoz to commercialize Vitaros in certain Asian and Pacific countries.
Basic net loss for the quarter ended March 31, 2016 was $2.5 million, or basic
loss per share of $0.05, compared to a net loss of $6.4 million, or $0.13 per
share for the first quarter of 2015. Reducing the net loss for the quarter
ended March 31, 2016 was a non-cash change in the fair value of the Company’s
warrant liability in the amount of $2.6 million.

As of March 31, 2016, cash and cash equivalents totaled $6.9 million, compared
to $3.9 million as of December 31, 2015.

2016 Financial Outlook

Early in the second quarter of 2016, Apricus reduced its staff, including the
executive team, by approximately 30%, decreased the size of the Board by one
member and reduced the Board’s cash compensation. Apricus plans to continue to
reduce operating expenses (excluding non-cash stock-based compensation expense
and depreciation expense), with a goal of achieving reductions of approximately
30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding
non-cash stock-based compensation expense and depreciation expense).

In 2016, Apricus expects to continue to generate cash from milestone or
licensing payments and royalty revenues from its partners sales of Vitaros.
Apricus will also continue to pursue out-licensing opportunities for Vitaros in
Asia-Pacific. Apricus’ expenditures will include minimal costs for the
preparatory Phase 2b clinical development of RayVa, as well as costs for
activities associated with supporting the regulatory approval of Vitaros in the
U.S. and the commercialization of Vitaros in Europe.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus’ commercial product,
Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and
Canada and is being commercialized in several countries in Europe. In September
2015, Apricus in-licensed the U.S. development and commercialization rights for
Vitaros from Allergan. Apricus’ marketing partners for Vitaros include
Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Recordati Ireland
Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring
Pharmaceuticals), Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has
one active product candidate, RayVa™, its product candidate for the treatment
of the circulatory disorder Raynaud’s phenomenon.

For further information on Apricus, visit

*Vitaros® is a registered trademark of NexMed International Limited. Such
trademark 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’ plans to
grow revenues for Vitaros® outside the United States, the timing of regulatory
submission and approval of Vitaros in the United States, if any; Apricus’ plans
for life-cycle development programs for Vitaros; Apricus’ development and
partnering plans for RayVa™; Apricus’ plans to pursue out-licensing
opportunities for Vitaros in Asia-Pacific; Apricus’ plans to reduce operating
expenses and achieve profitability, including projected 2016 and 2017 cost
savings; and Apricus’ 2016 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 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 the new strategic focus, workforce
reduction and other cost control measures; Apricus’ dependence on its
commercial partners to carry out the commercial launch or grow sales of Vitaros
in various territories and the potential for delays in the timing of commercial
launches in additional countries; competition in the erectile dysfunction
market and other markets in which Apricus and its partners operate; 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; Apricus’ ability to achieve U.S. and EU Orphan Designation for RayVa;
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 remain in compliance with the
terms and restrictions under the credit facility; Apricus’ ability to secure an
ex-U.S. strategic partner for RayVa and a licensing partner for Vitaros in
Asia-Pacific; 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 or without charge from Apricus.

(Financial Information to Follow)


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