RALEIGH, N.C., March 19, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) 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 (BNX) 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. (NASDAQ: ENDP) 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.
"The past fifteen months have been very exciting for BDSI as we have made significant progress in prudently deploying our resources and moving our company forward," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We are very pleased to partner with a company of the caliber of Endo Pharmaceuticals for BEMA Buprenorphine for chronic pain, with whom we are working towards initiation of two Phase 3 studies in the third quarter of this year. With Endo's added involvement in this development program and experience in pain, we believe the probability of a positive outcome in this program is enhanced. In addition, BEMA Buprenorphine is extremely complimentary to Endo's already impressive pain franchise and represents the only Schedule 3 opioid in their branded portfolio. We continue to believe that BEMA Buprenorphine has the potential to achieve peak sales in excess of $500 million."
According to Dr. Andrew Finn, Executive Vice President of Product Development, "As it relates to BNX, we began 2012 with a meeting with FDA and obtained clear guidance on this program that could lead to an NDA submission in the first half of 2013 and subsequently allow us to enter the rapidly growing market for the treatment of opioid dependence. BNX has the opportunity to be the first branded transmucosal buprenorphine/naloxone product to compete with Suboxone, which achieved sales in excess of $1.2 billion in 2011 and continues to grow."
2011 Corporate Update
By way of review, the following are key events that occurred at BDSI over the past 15 months:
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
"We look forward to another exciting year ahead and thank our shareholders for their continued support," said Dr. Sirgo. "Our product pipeline is strong as we move into 2012, behind the aggressive development of BEMA Buprenorphine and BNX in the substantial and growing pain and opioid dependence markets. Our licensing deal with Endo offers great promise for the future of BEMA Buprenorphine and its role in the treatment of chronic pain, and we continue to believe that there remains significant upside potential in the treatment of opioid dependence, where we have the opportunity to be the next branded transmucosal buprenorphine/naloxone product to reach the rapidly growing opioid dependence market. We believe there is a significant opportunity to enhance the value of the company this year behind the continued progress of our key assets, BEMA Buprenorphine and BNX."
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron). BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's 2012 initiatives described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.
|SOURCE BioDelivery Sciences International, Inc.|
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