Apricus Biosciences Provides Corporate Update and Second Quarter Financial Results
(Thomson Reuters ONE) -
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, Thursday, August 4, 2016 at 4:30 p.m. ET
SAN DIEGO, Aug. 04, 2016 (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 2016 and provided a corporate update on its priorities for 2016.
"In the second quarter, we sharpened our strategic focus in an effort to
maximize the regulatory and commercial success of Vitaros with the goal of
building a thriving and profitable global Vitaros brand," stated Richard W.
Pascoe, Chief Executive Officer. "Our primary corporate goal continues to be the
potential regulatory approval of Vitaros in the United States. In an effort to
advance our Vitaros NDA resubmission, we requested, and we were recently
granted, a Type B meeting with the FDA, scheduled for November 17, 2016. 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 submission, which we expect to occur
as soon as possible after the meeting. We view the granting of this meeting as
a favorable development and a reflection of our commitment to maintaining a
constructive relationship with all regulatory authorities. Additionally, we have
consolidated Vitaros territories in Europe and Asia with our newest partner
Ferring in an effort to expand the global availability of Vitaros and increase
revenue in important markets such as Germany. Moreover, we have substantially
reduced our operating expenses and improved our balance sheet as part of our
strategy to achieve profitability in 2017."
Second Quarter Highlights and Recent Developments
Apricus updated its corporate goals early in the second quarter 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. Second quarter and recent highlights include:
* Expanded the Company's exclusive Vitaros distribution agreement with Ferring
International S.A. in Latin America to now include Germany, Austria,
Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands,
Sweden, Switzerland and certain countries in Asia (previously Sandoz's
territories), the United Kingdom (previously Takeda's territory) and Korea
for up to an additional $3.85 million in upfront and pre-commercialization
milestone payments and up to an additional $1.5 million in launch milestone
payments, plus royalties on future net sales;
* Closed on a common stock purchase agreement with Aspire Capital. Aspire
Capital completed an initial purchase of 2,531,645 shares of common stock
for proceeds of $1.0 million and has committed to purchase up to $6.0
million in additional shares of common stock over the next 24 months. No
warrants were associated with this agreement;
* Announced receipt of regulatory approval of Vitaros in Lebanon by our
partner in the Middle East, Elis Pharmaceuticals, marking an important entry
into a highly attractive Middle Eastern erectile dysfunction market; and
* Obtained regulatory approval in Europe for an improved delivery device
material of construction for the refrigerated version of Vitaros.
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, with an NDA resubmission targeted for the fourth
quarter of 2016 and an approval decision expected after a six month review
period;
* Continue to support the Company's ex-U.S. partners' efforts to build a
global 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; 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((TM))(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; 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.
Second Quarter Financial Results
Revenue for each of the quarters ended June 30, 2016 and 2015 was $0.5 million.
Revenue during the quarter ended June 30, 2016 was comprised of $0.3 million in
royalty revenues, an increase of $0.2 million or 305.3% over the quarter ended
June 30, 2015. Revenue during the quarter ended June 30, 2015 included $0.4
million in product sales, the decline of which in 2016 was a result of our
commercialization partners working directly with our manufacturers. Net loss for
the quarter ended June 30, 2016 was $3.3 million, or loss per share of $0.05,
compared to a net loss of $5.2 million, or $0.10 per share for the second
quarter of 2015. Reducing the net loss for the quarter ended June 30, 2016 was a
non-cash change in the fair value of the Company's warrant liability in the
amount of $1.6 million.
As of June 30, 2016, cash and cash equivalents totaled $2.7 million, compared to
$3.9 million as of December 31, 2015. Cash and cash equivalents at June
30, 2016 do not reflect the receipt of $2.0 million in upfront payments received
in July related to the Ferring Northern Europe and Asia territory expansion, nor
any proceeds from sales of common stock to Aspire Capital.
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
Japan and China. 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 57715600. 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 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 Recordati
Ireland Ltd. (Recordati S.p.A.), 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((TM)), 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
development programs for Vitaros; Apricus' development and partnering plans for
RayVa((TM)); Apricus' plans to pursue out-licensing opportunities for Vitaros in
Japan and China; 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 FDA may reject our
strategy for addressing the deficiencies from the 2008 Complete Response letter
at our meeting in November 2016; 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 Japan and China; 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) (Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------- -------------------------
2016 2015 2016 2015
------------ ------------ ------------ ------------
Revenue
License fee revenue $ 50 $ - $ 50 $ 350
Royalty revenue 304 75 671 163
Product sales 110 387 369 424
------------ ------------ ------------ ------------
Total revenue 464 462 1,090 937
Cost of goods sold 93 509 326 742
------------ ------------ ------------ ------------
Gross profit (loss) 371 (47 ) 764 195
Research & development
expense 2,787 3,107 5,593 6,375
General & administrative
expense 2,294 2,669 4,698 5,765
------------ ------------ ------------ ------------
Total operating expense 5,081 5,776 10,291 12,140
Other income (expense) 1,372 578 3,684 288
------------ ------------ ------------ ------------
Net loss $ (3,338 ) $ (5,245 ) $ (5,843 ) $ (11,657 )
------------ ------------ ------------ ------------
Basic and diluted loss
per common share $ (0.05 ) $ (0.10 ) $ (0.10 ) $ (0.24 )
------------ ------------ ------------ ------------
Weighted average common
shares outstanding used
for basic and diluted
loss per share 61,817 50,414 58,433 49,031
------------ ------------ ------------ ------------
Condensed Consolidated Balance Sheets
(In thousands)
December
June 30, 31,
2016 2015
------------- ----------
(Unaudited)
Cash and cash equivalents $ 2,723 $ 3,887
Other current assets 2,202 2,330
Property and equipment, net 1,163 1,290
Other long term assets 78 274
------------- ----------
Total assets $ 6,166 $ 7,781
------------- ----------
Accounts payable, accrued expenses and other current
liabilities $ 4,945 $ 6,146
Notes payable 8,070 9,401
Warrant liability 2,211 1,841
Deferred revenue 250 137
Other long term liabilities 131 200
Stockholders' deficit (9,441 ) (9,944 )
------------- ----------
Total liabilities and stockholders' deficit $ 6,166 $ 7,781
------------- ----------
CONTACT:
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
[HUG#2032721]
Unternehmensinformation / Kurzprofil:
Datum: 04.08.2016 - 22:01 Uhr
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News-ID 487510
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