$23 million in cash at year-end 2009
ONSOLIS approval anticipated in E.U. and Canada in 2010
Company anticipates 3 products entering Phase 3 in early 2011
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) has filed its Annual Report with the U.S. Securities and Exchange Commission on Form 10-K for the fiscal year ended December 31, 2009. Such Form 10-K is available on the SEC''s website at www.sec.gov.
In addition, and in compliance with Nasdaq Marketplace Rule 5250(b)(2), the company disclosed a going concern qualification from its independent registered public accounting firm, Cherry, Bekaert & Holland, L.L.P. Nasdaq Rule 5250(b)(2) requires the separate disclosure of an audit opinion that contains a going concern qualification. Under current guidance, a going concern qualification means that, in the opinion of the auditing firm on the day they render their opinion, the company may not have sufficient cash and other resources available to run the business for the next twelve to fifteen months. Although BDSI had more than $23 million in cash on hand as of December 31, 2009, the going concern qualification was anticipated by the company given the company''s strategic plan that calls for more aggressive spending in support of its product pipeline in 2010 and beyond.
"We believe that the going concern opinion is driven more by the requirements of the accounting rules as opposed to what we believe are the promising prospects for our company," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "Although we now have a product on the market and significantly more cash on hand than we did a year ago, similar to last year, the going concern opinion was anticipated and not uncommon for maturing companies like ours with products in development. As a result of our efforts, we are hopeful to have three product candidates entering Phase 3 trials in early 2011, including: (1) BEMA Buprenorphine (low dose) for chronic pain; (2) BEMA Buprenorphine (high dose) for the treatment of opioid dependence; and (3) BEMA Granisetron for the prevention of cancer therapy induced nausea and vomiting. At this time, our main recurring revenue source is from royalties we receive on our marketed product ONSOLIS, which only recently launched in the U.S. It is still too early in the launch cycle to allow for a consistent or precise forecasting of our revenue, especially given the current regulatory landscape which we have previously outlined. Regardless, we have always maintained that our ONSOLIS royalties will not alone fund our strategic plan for developing our pipeline of products and growing our company; rather we believe that ONSOLIS will allow for a sound foundation around which we can grow the company."
Dr. Sirgo continued, "From a revenue perspective, in addition to royalties from sales of ONSOLIS in the U.S. in 2010 and into 2011, we also anticipate a $5 million milestone from our commercial partner Meda in conjunction with the approval and launch of ONSOLIS in Europe, royalties from sales of ONSOLIS that we expect to commence following launches in the E.U. and Canada, and the potential for a significant upfront payment related to a BEMA Buprenorphine commercial partnership. We believe that the achievement of these milestones will allow us to continue to build value for our stockholders."
About BioDelivery Sciences International
BioDelivery Sciences (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 Company''s patented BEMA buccal soluble film technology. ONSOLIS (fentanyl buccal soluble film) was approved by FDA on July 16, 2009, for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The commercial rights to ONSOLIS are licensed to Meda AB. Our second pain product, BEMA Buprenorphine, is in Phase 2 clinical development for the treatment of chronic pain, and in a higher dose formulation for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA "Triptan"). The Company is also working with its patented Bioral cochleate technology to facilitate oral dosing of drugs that would otherwise require intravenous administration. The first product under development using the technology is Bioral Amphotericin B. The Company''s headquarters is located in Raleigh, North Carolina. For more information please visit www.bdsi.com.
BDSI®, BEMA® and Bioral® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc.
Cautionary Note on Forward-Looking Statements
This press release and the 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," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," 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 strategic initiatives, actual cash flow and other financial results, and the Company''s ability to address its going concern qualification) 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.
Contacts:
ICR, Inc.
Donald Ellis
925-253-1240
donald.ellis@icrinc.com
or
BioDelivery
Sciences International, Inc.
Al Medwar
Vice President,
Marketing and Corporate Development
919-582-9050
amedwar@bdsi.com
