Why BioDelivery Sciences International, Inc. Shares Skyrocketed

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of BioDelivery Sciences International (NASDAQ: BDSI  ) , a biopharmaceutical company focused on developing therapies designed to treat pain management and oncology supportive care, skyrocketed by as much as 49% after it, and partner Endo Health Solutions (NASDAQ: ENDP  ) , reported their top-line results from a phase 3 trial of BEMA buprenorphine in opioid-naïve patients with moderate-to-severe chronic pain.

So what: According to the press release, the phase 3 trial met its primary endpoint of a reduction in the daily average pain numerical rating scale scores from baseline in a study involving chronic back pain. There is also an ongoing second phase 3 trial that could have results as early as the second-half of 2014. The positive results also triggered a $10 million milestone payment to BioDelivery Sciences from Endo according to BioDelivery CEO Mark Sirgo.

Now what: Although this is just top-line data, and we don't have the exact figures yet as they relate to NRS-pain score reduction, the simple fact that we're looking at a broad patient trial (462 patients) that met its endpoint is great news for the smaller BioDelivery Sciences. Milestone payments go a long way to fueling future research for a company that will likely burn through about $30 million in fiscal 2014 in total operating expenses, and only had $38.3 million in cash in the bank as of last quarter. However, much of that optimism has been baked into BioDelivery's share price already, leaving little room for more upside barring a flawless second phase 3 trial, FDA approval, and drug launch.

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  • Report this Comment On January 24, 2014, at 8:27 PM, richardsmeed wrote:

    "However, much of that optimism has been baked into BioDelivery's share price already, leaving little room for more upside barring a flawless second phase 3 trial, FDA approval, and drug launch."

    You should do your homework on a company before you publish articles. This is a small piece of the pie for BDSI. they already have a "suboxone killer" in the review process at the FDA with a decision date of June 14th. Potential sales of $500M they are launching a phase3 for diabetic neuropathy. In addition they will be relaunching in the USA Onsolis for breakthrough cancer pain which is already FDA approved. Potential revenue for BDSI is in excess of $1Billion dollars. This was the first major hurdle for them to cross the rest should be smooth sailing.

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Related Tickers

4/17/2014 4:00 PM
BDSI $7.42 Up +0.02 +0.27%
BIODELIVERY SCIENC… CAPS Rating: ***
ENDP $57.26 Down -0.44 -0.76%
Endo Health Soluti… CAPS Rating: ***

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