Titan Prepares For Big Summer 2015

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BioNap
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Summary

  • Titan's Phase 3 trial with Probuphine is fully-enrolled and we are expecting data in June 2015.
  • We expect the company to re-file the NDA shortly after the data presentation, and expect the review time will be six months. This puts the PDUFA early 2016.
  • Beyond Probuphine, Titan is also expanding the ProNeura technology to treat Parkinson's disease and other conditions where an implanted, time-released platform might benefit patients.
  • We believe the shares are worth $1 today and could be worth as much as $2 once Probuphine gets approved.

By Jason Napodano, CFA & Nisha Hirani, MD

On May 13, 2015, Titan Pharmaceuticals (NASDAQ:TTNP) reported financial results for the first quarter of 2015. The company reported total revenues of $0.9 million, which was consistent with all four quarters in 2014. Revenues reflected the amortization of upfront payments from Probuphine's commercialization partner, Braeburn Pharmaceuticals in December 2012. This was slightly above our expectations as were assuming that the remaining $1.7 million left to be paid by Braeburn would be split evenly over all four quarters in 2015, and so we are now projecting that the remaining $0.8 million will all be reflected in the second quarter of 2015.

Operating expenses for the first quarter totaled $2.5 million, comprised of $1.4 million in R&D and $1.1 million in G&A, and were above our expectations. R&D costs were higher than expected due to increases in external expenses associated with the completion of the Probuphine® product development program, and the preparation and review of the Probuphine® NDA prior to the receipt of the complete response letter ("CRL") in April 2013, as well as the ProNeura product development program. The increases in G&A expenses in the first quarter were due to higher non-cash stock compensation, and employee-related costs. We remind investors that the majority of the costs associated with the current clinical program are borne by Braeburn Pharmaceuticals, as per the terms of the amended license agreement.

Net other expense for the first quarter of 2015 was $3.3 million, compared with $0.9 million for the same period in 2014, and consisted of non-cash losses on changes in the fair value of warrants. Net loss for the first quarter 2015 was $4.9 million, or $0.04 per share, compared to $1.8 million, or $0.02 per share in the same quarter in 2014.

Net cash burn in

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Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. Business relationship disclosure: Please see additional disclosure about my employer linked above.

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