Hot FDA Trade: BioDelivery Sciences International
June 13, 2009
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 its 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.
An in-depth investor relations presentation dated March/2/09 can be found here (.pdf)
The company’s stock has also been on fire this year, sizzling past its previous 52 week high.
Flash Player 9 or higher is required to view the chart Click here to download Flash Player nowOnsolis 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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Disclosure: Short-Term Position
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By reading StocksHaven Investments you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
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June 13th, 2009 at 6:16 pm
Awesome, a Nasdaq bio-stock. I’ll definitely be looking into this, though it might be a bit too late to ride the FDA bandwagon on this one don’t you think? It has risen nearly 200% in the past 6 months.. and you’re expecting the decision on Monday.
June 13th, 2009 at 6:32 pm
@Daniel, It has one of the highest chances of FDA approval as compared to any drug this year, thus it still has potential for 100% gains upon acceptance.
June 13th, 2009 at 8:06 pm
As posted on as many boards that I can post until Monday, I urge all who read this follow suit and post on your respective stock boards. My request seems only fair since many of us don’t have the “clout” or should I say “paid positioning” the The Street has to get their trash posted as “journalism”.. It is obvious that the removal of TSCM from the Russell list is the beginning of the end for The Street and their contributors and some network affiliates. In my “freedom of speech” opinion, their actions over the course of several months may have finally given the SEC a solid platform to begin investigations. The Jon Stewart interview and Congressional requests for inquires of Jim Cramer may have highlighted the boiler room stock manipulation, which once was presumed a myth, is in fact alive and well both behind closed doors , within family circles, and promoted by so call experts such as in Adam Feuerstein and quite possibly some celebrity figureheads on several CNBC shows. In a recent article written to bash Hemispherx Bio (HEB) , Adam responded to a readers blog with total irreverence to the SEC and FTC referring to them as three letter organizations that he apparently has little to fear from. We as investors and Americans demand that the SEC begin investigating the complaints received and not bury these complaints under “political rugs” and bureaucratically convenient rhetoric. My personal request to the SEC is to freeze the funds of certain individuals and have a team on investigators dig deep into transfers and transaction to possibly uncover illegal price manipulation and laundering of accounts both here in the US and internationally. It would also be prudent for true journalists to admonish individuals much like Adam Feuerstein who hide behind a freedom that should never be tarnished by coercion to seemingly promote personal gain at the expense legitimate investors. Only time will tell….and the time is NOW.
June 13th, 2009 at 9:06 pm
@Vince, take it to ‘em.
June 14th, 2009 at 6:42 am
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June 14th, 2009 at 5:17 pm
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June 16th, 2009 at 7:39 am
This was a great PICK!! Thanks Mikey!