Biodel Meets Two-Face, The Joker, & The Riddler…..
If you just read headlines, you might have thought that Biodel Inc. (Nasdaq: BIOD) was going to have a good day. But it’s the exact opposite. Biodel has released study data from its pivotal Phase III trials for VIAject which met the primary endpoint of non-inferiority and results which demonstrated statistically significant reductions in hypoglycemic events and weight gain in Type 1 and 2 diabetes.
But the problems may be around the weight gain as the Type 2 diabetes patients showed a 0.7 pound weight gain over 26 weeks and Type 1 patients lost 0.7 pounds over that period. There were also results seen India that did not coincide with results in the US and Germany, which had to be excluded from results.
In both clinical trials, swelling, itching and redness were reported in less than 5% of patients receiving VIAject or RHI. VIAject was associated with injection site pain, the prevalence of which decreased with time. A combined total of 24 VIAject patients dropped out of the two clinical trials due to injection site pain (cry-babies).
The company is pleased with the decreases seen in hypoglycemic events and over those receiving insulin alone.
Shares are down almost 70% at $5.33 as of 9:53 AM EST and we have seen more than 2.5 million shares trade hands. The 52-week trading range was $9.60 to $25.69. The company may be pleased, but Wall Street isn’t. Not at all.
With a $126 million market cap, the stock trades at about 1.25 times its last stated net tangible assets as of June 30, 2008.
Jon C. Ogg
September 8, 2008