Apricus Biosciences, Inc. (APRI) 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 Abbott Laboratories (ABT) and Takeda Pharmaceutical Co. Ltd. (TKPYY), 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 Europe.
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. (JAZZ) looks more attractive with a Zacks Rank #1 (Strong Buy).
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