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2016-11-08

Apricus Biosciences Provides Corporate Update and Third Quarter Financial Results

Apricus Biosciences, Inc.
Press release

Apricus Biosciences Provides Corporate Update and Third Quarter Financial
Results

Strategic Focus on Growing Global Vitaros® Revenue and Achieving Profitability
in 2017
Apricus Granted Type B Meeting with FDA to Discuss the Vitaros® U.S. NDA
Re-Submission
Conference Call / Webcast Today, Tuesday, November 8, 2016 at 4:30 p.m. ET

SAN DIEGO, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today reported financial results for the third
quarter of 2016 and provided a corporate update on its priorities for 2016.

“In the third quarter, we focused our efforts on advancing the regulatory and
commercial success of Vitaros® through our partners. Since July, our partners
have launched Vitaros in five additional countries in Europe, and received an
additional five marketing authorizations for Vitaros in Europe, Latin America
and the Middle East. Further, the transfer of commercial rights to Ferring in
certain countries in Europe and Asia was completed,” stated Richard W. Pascoe,
Chief Executive Officer. “Looking forward, our focus continues to be
increasing Vitaros ex-U.S. revenue and obtaining the regulatory approval of
Vitaros in the United States. Our Type B meeting with the FDA, which is
scheduled for November 17, 2016, remains on schedule. The purpose of this
meeting is to confirm our strategy for addressing the deficiencies contained in
the original 2008 Complete Response letter. We will incorporate any FDA
feedback into the final resubmission, which we expect to occur in the fourth
quarter.”

Third Quarter Highlights and Recent Developments

Apricus continued to focus its corporate goals 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. Third
quarter and recent highlights include:

-- Announced receipt of regulatory approval of Vitaros in Lebanon by the
Company’s partner in the Middle East, Elis Pharmaceuticals, marking an
important entry into a highly attractive Middle Eastern erectile
dysfunction market;
-- Obtained regulatory approval in Europe for an improved delivery device
material of construction for the refrigerated version of Vitaros;
-- Completed the transfer of the Vitaros marketing authorizations in Germany,
the United Kingdom, Finland and Denmark to Ferring Pharmaceuticals
(Ferring);
-- Announced launch of Vitaros in Portugal, Ireland, Poland, Czech Republic
and Slovakia by the Company’s partner, Recordati Ireland Ltd. (Recordati);
-- Announced receipt of regulatory approval of Vitaros in Argentina by
Ferring, marking the first country in Latin America to do so; and
-- Closed two separate offerings of common stock and warrants with
institutional investors for gross proceeds of approximately $4.9 million.

Strategic Priorities

Apricus continues to focus 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. Apricus was granted an FDA Type-B meeting on
November 17, 2016, following which the Company intends to resubmit the
Vitaros NDA. An FDA approval decision is expected after a six month
review period;
-- Continue to support the Company’s ex-U.S. partners’ efforts to build a
global Vitaros brand and increase revenue by supporting new commercial
launches by the Company’s partners and assisting the Company’s partners in
obtaining additional regulatory approvals in their respective territories;
-- Continue the Company’s efforts to license Vitaros in available countries
throughout Asia to include Japan, China and India; 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
and to deliver a commercially viable refrigerated product in Canada.

RayVa™(alprostadil)

-- Explore Orphan Drug Designation in the U.S. and EU; and
-- Explore global or regional partnerships prior to initiating the Phase 2b
study.

Corporate/Financial

-- Reduce operating expenses by approximately 30% in 2016 and 60% in 2017 as
compared to 2015 operating expenses;
-- Work with NASDAQ to try and regain compliance with the minimum $35 million
market value of listed securities requirement as required for continued
listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2)
prior to November 29, 2016; and
-- Grow Vitaros revenue, seek non-dilutive capital and utilize lower cost of
capital financial instruments to fund operations with the goal of achieving
profitability in 2017.

Third Quarter Financial Results

Total revenues for the quarter and year to date period ended September 30, 2016
were $4.3 million and $5.4 million, respectively, as compared to $1.3 million
and $2.2 million for the quarter and year to date period ended September 30,
2015, respectively. The increase for both periods was primarily due to the
recognition in the third quarter of 2016 of $3.9 million due to the expansion
of the Company’s license agreement with Ferring. Cost of goods sold for the
quarter and year to date period ended September 30, 2016 were $0.1 million and
$0.4 million, as compared to $0.1 million and $0.9 million for the quarter and
year to date period ended September 30, 2015. Cost of Sandoz rights for the
quarter and year to date period ended September 30, 2016 includes $3.4 million
incurred as a cost of reacquiring and relicensing the rights to certain
territories previously licensed to Sandoz. Research and development expense
for the nine months ended September 30, 2016 was $6.0 million, as compared to
$11.0 million for the nine months ended September 30, 2015. The decrease was
primarily due to decreased spending on outside services related to the
development of fispemifene, Vitaros and RayVa. General and administrative
expense for the nine months ended September 30, 2106 was $6.5 million, as
compared to $8.2 million for the nine months ended September 30, 2015. The
decrease was primarily due to lower professional services expenses, such as
legal and accounting expenses, and reductions in personnel-related expenses,
including travel. Net loss for the quarter ended September 30, 2016 was $1.3
million, or loss per share of $0.19, compared to a net loss of $5.0 million, or
$1.00 per share for the third quarter of 2015. Net loss for the nine months
ended September 30, 2016 was $7.1 million, or loss per share of $1.17,
compared to a net loss of $16.7 million, or loss per share of $3.37 for the
nine months ended September 30, 2015. Reducing the net loss for the nine
months ended September 30, 2016 was a non-cash change in the fair value of the
Company’s warrant liability in the amount of $5.1 million.

As of September 30, 2016, cash and cash equivalents totaled $5.6 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. 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.

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 8654347. 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’ commercial product,
Vitaros®, for the treatment of erectile dysfunction, is approved in Canada and
certain countries in Europe, Latin America and the Middle East 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 Recordati Ireland
Ltd. (Recordati), Ferring International Center S.A. (Ferring Pharmaceuticals),
Laboratoires Majorelle, Bracco S.p.A., 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 http://www.apricusbio.com.

*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 and
significance of the Type B meeting with the FDA, the timing of regulatory
submission and approval of Vitaros in the United States, if any; Apricus’ plans
for life-cycle...

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