BioDelivery Sciences Provides Business Review

BioDelivery Sciences International, Inc.

announced that it has filed its Annual Report on Form 10-K for the year ended December 31, 2011, with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of the Company's achievements and an update on business operations and upcoming milestones for 2012. In 2011, BDSI made significant strides in progressing development of its two lead products, BEMA Buprenorphine for chronic pain and BEMA Buprenorphine/Naloxone (

) for opioid dependence. As such, but as expected, BDSI increased its expenditures and therefore reported a net loss of $23.3 million, or ($0.82) per share, for the twelve months ending December 31, 2011, as compared to a net loss of $13.0 million, or $(0.56) per share, for the twelve months ending December 31, 2010. The increased net loss is due primarily to increased research and development expenses which totaled $20.8 million in 2011, compared to $10.6 million in 2010. Conduct of the Phase 3 trial for BEMA Buprenorphine in chronic pain and initial studies for BNX are primarily responsible for higher research and development expenses in 2011. At December 31, 2011, BDSI had $10.8 million in cash compared to $18.2 million at December 31, 2010. BDSI received an upfront payment of $30 million in early January 2012 with the signing of a license and development agreement with Endo Pharmaceuticals, Inc.

for BEMA Buprenorphine for the treatment of chronic pain. A $15 million milestone payment, for granting of a patent extending the exclusivity of BEMA Buprenorphine and BNX through 2027, is expected by the end of second quarter 2012. The allowance of the patent was made by the United States Patent and Trademark Office (USPTO) in February 2012, while the formal granting that triggers this milestone payment typically occurs within 3 months of the allowance.