Apricus Biosciences Provides Corporate Update and Second Quarter 2017 Financial Results
(Thomson Reuters ONE) -
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 Six Months Ended
June 30, 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)
December
June 30, 31,
2017 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
------------- ----------
CONTACT:
Matthew Beck
mbeck(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2017 - 22:01 Uhr
Sprache: Deutsch
News-ID 555124
Anzahl Zeichen: 14644
contact information:
Town:
SAN DIEGO
Kategorie:
Business News
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