BioDelivery Sciences International, Inc announced receipt of $26.7 million milestone payments from its commercial partner Meda AB in connection with the approval by the US Food and Drug Administration (FDA) of BDSI's breakthrough cancer pain product Onsolis (fentanyl buccal soluble film) and satisfactory preparation of commercial launch supplies.
In addition to the $26.7 million received, BDSI will also receive a double-digit royalty on net sales of Onsolis, and the potential for additional milestone payments of up to another $30 million upon the achievement of certain sales thresholds. Onsolis will be commercialized in the US by Meda Pharmaceuticals, the US subsidiary of Meda AB and is expected to be available for sale early fourth quarter of this year.
"The receipt of this milestone payment, together with approximately $5 million we have received from the exercise of outstanding warrants over the past several weeks, puts the company in the strongest financial position in its history, with approximately $30 million in cash and no long term debt. These funds allow us to immediately turn to accelerating the development of our exciting pipeline, particularly Bema Buprenorphine and Bioral Amphotericin B, as well as to place a third Bema product in the clinic next year," stated Dr Mark A Sirgo, president and chief executive officer of BioDelivery Sciences.
"In addition, we expect that receipt of these funds will leave BDSI cash flow positive from operations and with nearly $60 million in recognized revenue for 2009," added Dr Sirgo. "Moreover, with the launch of Onsolis expected in early fourth quarter of this year, we also expect that we will begin receiving royalty income. In short, our economic outlook and ability to execute our business plan have never been better."
BDSI had previously recorded milestone payments from Meda as deferred revenue, and with the FDA approval, those amounts, together with the approval milestone, will be recognized as revenue to the company.
Dr Sirgo also stated, "We anticipate significant news flow in the coming months regarding the launch of Onsolis by Meda Pharmaceuticals and the progress of our product pipeline. Of note, we anticipate year end results from our phase-2 dental pain study with Bema Buprenorphine, which we believe could lead to a sizable licensing transaction in 2010. We also hope to have completed our next phase-1 trial with Bioral Amphotericin B this year before moving to phase-2 in the first half of 2010. Now, with an FDA approved product in Onsolis, a validated technology in Bema, an exciting pipeline of products and cash on hand, we believe that our ability to drive shareholder value has never been better."
Onsolis is the first product to utilize the company's proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek).