BioDelivery Sciences International announces filing of Annual Report with U.S. SEC

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

“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”

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.”

Source BioDelivery Sciences International


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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