Apricus Biosciences, Inc.
) reported third quarter 2013 loss of 10 cents per share, in line
with the Zacks Consensus Estimate but wider than the year-ago
loss of 7 cents.
Revenues in the reported quarter were $28000, much lower than
year-ago revenues of $4.9 million and the Zacks Consensus
Estimate of $1 million. Revenues in the year-ago quarter
comprised license fee and contract service revenues whereas the
reported quarter only included contract service revenues.
In the 2012 quarter license fees worth $2.5 million and $1.0
million were recognized from
Takeda Pharmaceutical Co. Ltd.
), respectively. The decline in contract service revenues in the
reported quarter was due to activity related to French
subsidiaries in the third quarter of 2012, which was
deconsolidated in the second quarter 2013.
In the third quarter 2013, research and development (R&D)
expenses were $0.9 million as compared with $2 million in the
year-ago quarter. The decline in expenses was driven by decreased
consulting services in support of regulatory filings in
Vitaros (erectile dysfunction) is the only approved product of
Apricus. In Jun 2013, Apricus received approval for Vitaros under
the European Decentralized Procedure (DCP). By far it has
received five national phase approvals in Europe, which include
Germany, Ireland, the Netherlands, Sweden and the
U.K. Gaining country by country national phase approvals in
the remaining territories is in progress. Current partners in
Europe are preparing for an expected commercial launch in their
respective territories in 2014.
The next-generation, room temperature version of Vitaros is
expected to have a targeted shelf life of at least 24 months and
will not require refrigeration. Apricus expects the new
version of Vitaros to drive growth in 2015 and beyond.
Earlier this month, Apricus entered into a partnership with
Laboratoires Majorelle in France, Monaco and Africa. Apricus
expects to announce one or more Vitaros related partnerships by
year end and expects the rollout of multiple Vitaros launches
across Europe in 2014.
In Aug 2013, Apricus completed an end of phase II meeting with
the U.S. Food and Drug Administration (FDA) for its pipeline
candidate Femprox (female sexual dysfunction treatment). The
agency said that the proposed indication can be pursued in both
pre- and post-menopausal women, but the efficacy in each cohort
must be demonstrated separately. The agency guided that a future
study of Femprox should incorporate endpoints that would be used
to validate the arousal domain of female sexual function index
(FSFI). Moreover, the FDA stated that no additional non-clinical
studies, other than a reproductive and developmental assessment,
would be required to support a New Drug Application (NDA).
We believe investor focus will remain on updates pertaining
to Vitaros and Femprox.
Currently, Apricus carries a Zacks Rank #2 (Buy). Currently,
Jazz Pharmaceuticals Ltd.
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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