BioDelivery Sciences International

(NASDAQ:BDSI)

Continuing with the trend of pre-FDA decision BioPharma companies, StocksHaven Investments takes a closer look at BDSI which hopes it’s product Onsolis will strive past approval and make its way onto shelves world-wide.

About BDSI: BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is utilizing licensed and owned drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, significant new formulations of proven therapeutics. Utilizing its drug delivery technologies, the Company is developing formulations of pharmaceuticals aimed at acute (short term) conditions occurring in patients, mostly notably in the areas of pain and fungal infections.

Onsolis: BDSI®’s first application of the lead BEMA™ technology is Onsolis™ (fentanyl buccal soluble film). Onsolis™ utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer film for application to the buccal membranes (inner lining of the cheek). Expected FDA decision ( 6/15/09 )

The global market for pain medication generates annual sales of over $30 billion. Datamonitor estimates the current market for the proposed use of Onsolis™ to be approximately $700 million. BDSI® believes that Onsolis™ has the potential to capture a significant share of the U.S. market for this use, which is estimated to result in annual peak sales of over $200 million.

Commercialization rights to Onsolis™ have been licensed to MEDA AB for North America and Europe. MEDA AB is an international specialty pharmaceutical company that concentrates on marketing and market-adapted product development. Meda is represented in 26 countries and with more than 1,500 employees within marketing and sales. Meda’s products are sold in approximately 120 countries world-wide.

Earlier this year, BDSI raised $6M in cash from partner Meda AB [STO:MEDAA] ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company’s current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.

The company’s stock has also been on fire this year, sizzling past its previous 52 week high.

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Onsolis is not the only product which BioDelivery Sciences is tackling on, take a look at the product pipeline chart:

More information on BEMA and Bioral is available [ here ]

The importance in this is that it proves BioDelivery Sciences is not a one-product dependant company. With multiple ones on the way, it should instill confidence simultaneously for both short-term pre-FDA investors, and long-term shareholders as well. While StocksHaven Investments does not usually hold companies through events such as FDA decisions and clinical results, BDSI is an exception as it will expect to see positive cash flow should Onsolis gain approval, and with the company being debt-free, the future potential should definitely outweigh the negatives.

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