Apricus Biosciences Announces First Quarter 2012 Financial Results Conference Call and Provides Corporate Update
Apricus Biosciences, Inc.
08.05.2012 15:49
---------------------------------------------------------------------------
Conference Call/Webcast to be Held Thursday, May 10, 2012 at 4:30 p.m. ET
SAN DIEGO, 2012-05-08 15:49 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today that
management will hold a conference call to discuss its first quarter 2012
financial results and ongoing corporate activities on Thursday, May 10, 2012 at
4:30 p.m. ET. The Company will file its Form 10-Q for the quarter ended March
31, 2012 by the close of business on Thursday, May 10, 2012.
'Early 2012 has been an important period of transition towards our product
commercialization strategy,' said Dr. Bassam Damaj, President and Chief
Executive Officer. 'We successfully monetized two of our NexACT(r) delivery
platform products in certain territories through the execution of licensing
transactions worth up to $54 million in milestone revenue, in addition to
royalty revenue. Beyond NexACT(r), we made progress building our oncology
supportive care commercial platform with the acquisition of rights to two
marketed products. We also completed a $20 million public offering, which
strengthened the balance sheet and brought us the working capital to accelerate
development of several of the Company's key initiatives and sustain us into the
middle of 2014.'
Dr. Damaj added, 'Looking ahead, we remain focused on executing our growth
strategy, which includes developing, commercializing, and partnering products
that incorporate our NexACT(r) technology and building our revenue generating
platform.'
First Quarter 2012 and Recent Highlights
- Announced exclusive, high-value licensing deals for Vitaros(r) and MycoVa(tm). In
the first quarter of 2012, Apricus Bio announced deals with Abbott Laboratories
in Canada and Sandoz/Novartis in Germany to market Vitaros(r), the Company's lead
product candidate for the treatment of erectile dysfunction. Combined, these
transactions are worth over $44 million in upfront and future potential
milestone payments, in addition to double-digit royalties. Apricus Bio also
completed first quarter transactions for MycoVa(tm), the Company's treatment for
onychomycosis, with Stellar Pharmaceuticals and Elis Pharmaceuticals, bringing
over $10 million in upfront and future potential milestone payments, in
addition to royalties.
- Announced expansion of commercial division, Apricus Pharmaceuticals USA,
Inc., with the licensing of U.S. rights to Granisol(r) and Aquoral(tm). Apricus Bio
continued to build its recently launched commercial arm with the acquisition of
two oncology supportive care products, Granisol(r) for the prevention of nausea
and vomiting associated with cancer therapy or radiation, and Aquoral(tm) spray
for Xerostomia or dry mouth, which is prevalent in patients undergoing cancer
therapy. These new assets, combined with Totect(r), the Company's treatment for
anthracycline extravasation, create a commercial platform that has significant
revenue potential. The Company is working toward a more formal re-launch of all
three products in 2012.
- Announced completion of $20 million public offering. In February 2012, the
Company completed a $20 million financing, which brought healthcare-focused,
institutional investors into the stock, strengthened the balance sheet, and
provided the capital to push forward with key corporate initiatives.
Key Upcoming Milestones
- Commercialization of Vitaros(r) in Canada. The Company's Canadian partner,
Abbott Laboratories, has indicated their intention to launch Vitaros(r) for the
treatment of erectile dysfunction in the second half of 2012. The Company
initiated manufacturing of three commercial batches of Vitaros(r) at its
manufacturing partner Therapex's facility for the launch of the product by
Abbott this year.
- Continued partnerships of Vitaros(r) in Europe. Apricus Bio continues to engage
in partnership discussions for Vitaros(r) throughout the remaining territories in
Europe and look forward to announcing signed partnerships with upfront cash,
milestones, and royalties. The Company is in multiple commercial contract
negotiations for several territories in Europe, which it expects to finalize in
the third or fourth quarters of this year. In addition, the Company is
evaluating multiple opportunities to expand into one of the largest Alprostadil
markets and one of the largest erectile dysfunction markets in Europe in
anticipation of the potential approval of Vitaros(r) later this year or early
2013.
- Regulatory guidance for Femprox(r) development program. The Company believes
that Femprox(r), Apricus Bio's topical cream for the treatment of female sexual
arousal disorder, is further along than any other product in this indication
and is the only product to successfully complete an approximately 400 patient
Phase III clinical study. The Company was granted a pre-NDS meeting with Health
Canada on July 17, 2012 to obtain guidance regarding the suitability of their
existing clinical, preclinical, and chemistry data to support a New Drug
Submission ('NDS') in Canada. The Company has also requested a Type C meeting
with the U.S. Food and Drug Administration ('FDA') and expects to request a
guidance meeting in Europe in the coming weeks.
- Regulatory guidance for MycoVa(tm) development program. MycoVa(tm) is the Company's
late-stage topical treatment for mild to moderate onychomycosis. The Company
expects to have guidance regarding the next regulatory steps from the health
agencies in the U.S., Europe and Canada by the third quarter of 2012. The
Company requested a Type C meeting with the FDA in May 2012 relating to
receiving guidance on the approvability of MycoVa(tm) in the United States. In
addition, the Company requested a guidance meeting with Health Canada and also
requested a guidance meeting with two European agencies.
- Formal re-launch of oncology supportive care commercial products. Apricus Bio
is currently building or sourcing the required manufacturing infrastructure to
support global or regional supply capacity for Totect(r), Granisol(r) and Aquoral(tm).
The Company is working toward a formal re-launch of all three products this
year, and expects to recognize revenue in 2012. Additionally, the Company is
currently in multiple partnership negotiations to commercialize Granisol(r)
outside the United States. The Company has started the initial registration
procedures for Granisol(r) in multiple countries.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the
U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus
Bio Conference Call. The teleconference replay will be available for one week
by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing
201-612-7415. Replay passcodes 286 and 394141 are both required for playback.
The conference call will also be webcast live at
http://www.investorcalendar.com/IC/CEPage.asp?ID=168504. The webcast replay
will be available for three months.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company,
with commercial products and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT(r) technology.
Apricus Bio's current NexACT(r) pipeline includes Vitaros(r), approved in Canada
for the treatment of erectile dysfunction, as well as compounds in development
from pre-clinical through pre-registration currently focused on Sexual
Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes
and Consumer Healthcare.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliv) and (c) NitroMist(r) (nitroglycerin sublingual
spray), an FDA-approved nitrate vasodilator indicated for acute relief of an
attack or acute prophylaxis of angina pectoris (chest pain) due to coronary
artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and
for information on its subsidiary please visit http://www.nexmedusa.com. You
can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, its ability to further develop its products and
product candidates, to have its products and product candidates such as
Vitaros(r), Femprox(r) and MycoVa(tm) receive patent protection and be approved by
relevant regulatory authorities, to successfully commercialize such products as
Totect(r), Granisol(r) , Aquoral(tm) and NitroMist(tm) and NexACT(r) product candidates and
drug delivery technology and to achieve its development, commercialization and
financial goals. Readers are cautioned not to place undue reliance on these
forward-looking statements as actual results could differ materially from the
forward-looking statements contained herein. Readers are urged to read the risk
factors set forth in the Company's 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 or without
charge from the Company.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
08.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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Apricus Biosciences, Inc.
08.05.2012 15:49
---------------------------------------------------------------------------
Conference Call/Webcast to be Held Thursday, May 10, 2012 at 4:30 p.m. ET
SAN DIEGO, 2012-05-08 15:49 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today that
management will hold a conference call to discuss its first quarter 2012
financial results and ongoing corporate activities on Thursday, May 10, 2012 at
4:30 p.m. ET. The Company will file its Form 10-Q for the quarter ended March
31, 2012 by the close of business on Thursday, May 10, 2012.
'Early 2012 has been an important period of transition towards our product
commercialization strategy,' said Dr. Bassam Damaj, President and Chief
Executive Officer. 'We successfully monetized two of our NexACT(r) delivery
platform products in certain territories through the execution of licensing
transactions worth up to $54 million in milestone revenue, in addition to
royalty revenue. Beyond NexACT(r), we made progress building our oncology
supportive care commercial platform with the acquisition of rights to two
marketed products. We also completed a $20 million public offering, which
strengthened the balance sheet and brought us the working capital to accelerate
development of several of the Company's key initiatives and sustain us into the
middle of 2014.'
Dr. Damaj added, 'Looking ahead, we remain focused on executing our growth
strategy, which includes developing, commercializing, and partnering products
that incorporate our NexACT(r) technology and building our revenue generating
platform.'
First Quarter 2012 and Recent Highlights
- Announced exclusive, high-value licensing deals for Vitaros(r) and MycoVa(tm). In
the first quarter of 2012, Apricus Bio announced deals with Abbott Laboratories
in Canada and Sandoz/Novartis in Germany to market Vitaros(r), the Company's lead
product candidate for the treatment of erectile dysfunction. Combined, these
transactions are worth over $44 million in upfront and future potential
milestone payments, in addition to double-digit royalties. Apricus Bio also
completed first quarter transactions for MycoVa(tm), the Company's treatment for
onychomycosis, with Stellar Pharmaceuticals and Elis Pharmaceuticals, bringing
over $10 million in upfront and future potential milestone payments, in
addition to royalties.
- Announced expansion of commercial division, Apricus Pharmaceuticals USA,
Inc., with the licensing of U.S. rights to Granisol(r) and Aquoral(tm). Apricus Bio
continued to build its recently launched commercial arm with the acquisition of
two oncology supportive care products, Granisol(r) for the prevention of nausea
and vomiting associated with cancer therapy or radiation, and Aquoral(tm) spray
for Xerostomia or dry mouth, which is prevalent in patients undergoing cancer
therapy. These new assets, combined with Totect(r), the Company's treatment for
anthracycline extravasation, create a commercial platform that has significant
revenue potential. The Company is working toward a more formal re-launch of all
three products in 2012.
- Announced completion of $20 million public offering. In February 2012, the
Company completed a $20 million financing, which brought healthcare-focused,
institutional investors into the stock, strengthened the balance sheet, and
provided the capital to push forward with key corporate initiatives.
Key Upcoming Milestones
- Commercialization of Vitaros(r) in Canada. The Company's Canadian partner,
Abbott Laboratories, has indicated their intention to launch Vitaros(r) for the
treatment of erectile dysfunction in the second half of 2012. The Company
initiated manufacturing of three commercial batches of Vitaros(r) at its
manufacturing partner Therapex's facility for the launch of the product by
Abbott this year.
- Continued partnerships of Vitaros(r) in Europe. Apricus Bio continues to engage
in partnership discussions for Vitaros(r) throughout the remaining territories in
Europe and look forward to announcing signed partnerships with upfront cash,
milestones, and royalties. The Company is in multiple commercial contract
negotiations for several territories in Europe, which it expects to finalize in
the third or fourth quarters of this year. In addition, the Company is
evaluating multiple opportunities to expand into one of the largest Alprostadil
markets and one of the largest erectile dysfunction markets in Europe in
anticipation of the potential approval of Vitaros(r) later this year or early
2013.
- Regulatory guidance for Femprox(r) development program. The Company believes
that Femprox(r), Apricus Bio's topical cream for the treatment of female sexual
arousal disorder, is further along than any other product in this indication
and is the only product to successfully complete an approximately 400 patient
Phase III clinical study. The Company was granted a pre-NDS meeting with Health
Canada on July 17, 2012 to obtain guidance regarding the suitability of their
existing clinical, preclinical, and chemistry data to support a New Drug
Submission ('NDS') in Canada. The Company has also requested a Type C meeting
with the U.S. Food and Drug Administration ('FDA') and expects to request a
guidance meeting in Europe in the coming weeks.
- Regulatory guidance for MycoVa(tm) development program. MycoVa(tm) is the Company's
late-stage topical treatment for mild to moderate onychomycosis. The Company
expects to have guidance regarding the next regulatory steps from the health
agencies in the U.S., Europe and Canada by the third quarter of 2012. The
Company requested a Type C meeting with the FDA in May 2012 relating to
receiving guidance on the approvability of MycoVa(tm) in the United States. In
addition, the Company requested a guidance meeting with Health Canada and also
requested a guidance meeting with two European agencies.
- Formal re-launch of oncology supportive care commercial products. Apricus Bio
is currently building or sourcing the required manufacturing infrastructure to
support global or regional supply capacity for Totect(r), Granisol(r) and Aquoral(tm).
The Company is working toward a formal re-launch of all three products this
year, and expects to recognize revenue in 2012. Additionally, the Company is
currently in multiple partnership negotiations to commercialize Granisol(r)
outside the United States. The Company has started the initial registration
procedures for Granisol(r) in multiple countries.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the
U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus
Bio Conference Call. The teleconference replay will be available for one week
by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing
201-612-7415. Replay passcodes 286 and 394141 are both required for playback.
The conference call will also be webcast live at
http://www.investorcalendar.com/IC/CEPage.asp?ID=168504. The webcast replay
will be available for three months.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company,
with commercial products and a broad pipeline across numerous therapeutic
classes.
Revenues and growth are driven from the sales of the Company's commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT(r) technology.
Apricus Bio's current NexACT(r) pipeline includes Vitaros(r), approved in Canada
for the treatment of erectile dysfunction, as well as compounds in development
from pre-clinical through pre-registration currently focused on Sexual
Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes
and Consumer Healthcare.
Apricus Bio currently markets Totect(r) (dexrazoxane HCl), the only drug approved
in the US for the treatment of anthracycline extravasation. The Company also
plans to market in the U.S. or certain other countries the following products:
(a) Granisol(r) (granisetron HCI) oral solution, the only FDA-approved, oral,
ready-to-use liquid solution of granisetron, (b) Aquoral(tm), an FDA-cleared,
prescription-only spray for the treatment of Xerostomia (the medical term for
dry mouth due to a lack of saliv) and (c) NitroMist(r) (nitroglycerin sublingual
spray), an FDA-approved nitrate vasodilator indicated for acute relief of an
attack or acute prophylaxis of angina pectoris (chest pain) due to coronary
artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and
for information on its subsidiary please visit http://www.nexmedusa.com. You
can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, its ability to further develop its products and
product candidates, to have its products and product candidates such as
Vitaros(r), Femprox(r) and MycoVa(tm) receive patent protection and be approved by
relevant regulatory authorities, to successfully commercialize such products as
Totect(r), Granisol(r) , Aquoral(tm) and NitroMist(tm) and NexACT(r) product candidates and
drug delivery technology and to achieve its development, commercialization and
financial goals. Readers are cautioned not to place undue reliance on these
forward-looking statements as actual results could differ materially from the
forward-looking statements contained herein. Readers are urged to read the risk
factors set forth in the Company's 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 or without
charge from the Company.
CONTACT: Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
News Source: NASDAQ OMX
08.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------