By way of review, the following are key events that occurred at BDSI over the past 15 months:
- BEMA Buprenorphine - Chronic Pain. Early in 2012, BDSI signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones and thresholds are met, resulted in the payment of a $30 million license fee at signing and $15 million in April 2012 upon the granting of a patent extending the exclusivity of BEMA products containing buprenorphine from 2020 to 2027. The partnership also grants BDSI the potential to receive sales threshold payments as well as a tiered mid- to upper-teen royalty on net sales in the U.S. following FDA approval. In August, BDSI and Endo initiated the Phase 3 clinical studies of BEMA Buprenorphine for the treatment of moderate to severe chronic pain. Two efficacy studies, one in opioid naïve and one in opioid experienced subjects, are currently enrolling patients.
- BUNAVAIL - Opioid Dependence. BUNAVAIL, formerly referred to as BEMA Buprenorphine/Naloxone or BNX, is being developed for the treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. In September 2012, BDSI announced a positive outcome of the pivotal pharmacokinetic study and in January 2013 announced completion of the safety study, which demonstrated favorable tolerability in 249 opioid dependent subjects switched from Suboxone to BUNAVAIL.
- ONSOLIS/BREAKYL. In October, BDSI announced the commercial launch of BREAKYL (fentanyl buccal film) in the European Union. Under the terms of its agreement with its commercial partner Meda, BDSI received a final milestone payment of $2.5 million and will also receive a royalty on net sales of BREAKYL in the E.U. The launch of BREAKYL also triggered the recognition of $17.5 million of previously deferred revenue.
- $40 Million Registered Financing. In December, BDSI closed a registered direct financing (priced at market and with no warrant coverage) which yielded gross proceeds of $40 million to BDSI, of which 70% was received from current investors. Proceeds are expected to fund the clinical programs of both BEMA Buprenorphine and BUNAVAIL while providing a strong balance sheet for potential licensing discussions for BUNAVAIL for both the U.S. and abroad or as BDSI considers commercializing BUNAVAIL on its own.
Anticipated 2013 Milestones