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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Date:11/8/2012

projected peak annual U.S. sales.  Finally, our partnering discussions continue around BNX as we also consider the option of commercializing this product ourselves."

At September 30, 2012, BDSI had $31.3 million in cash compared to $10.8 million at December 31, 2011.  For 2012 year-to-date, BDSI had positive cash flow of $19.7 million compared to negative cash flow in the same period in 2011 of $18.9 million.  In October 2012, BDSI received a $2.5 million milestone payment from Meda as a result of the launch of BREAKYL in Europe. 

Research and development costs in the third quarter 2012 totaled $12.5 million, compared to $6.2 million in the third quarter of 2011.  The increase is due to additional research and development costs associated with the concomitant running of the BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) Phase 3 trials. 

Third Quarter 2012 and Recent Corporate Update

The following are key events that occurred at BDSI during the third quarter of 2012:

  • BEMA Buprenorphine - Chronic Pain.  BDSI and Endo announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain.  The Phase 3 program will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects.  Both studies are anticipated to be completed by late 2013 or early 2014.  Both are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. 

    BDSI's licensing agreement with Endo for BEMA Buprenorphine calls for milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, upon the acceptance of filing of the New Drug Application (NDA) by the FDA.  These payments would, if achieved, total $30 million.  

    SOURCE BioDelivery Sciences International, Inc.
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