ADLR announced 4q2010 results yesterday morning 2/23/10 and held a brief conference call for investors. Here are the salient notes:
First, here is the earnings press release link
I also have updated the ADLR research page at this link
Year end cash balance was $46.6m, burned $36.6m cash in 2010
Entereg Notes
First, here is the earnings press release link
I also have updated the ADLR research page at this link
Year end cash balance was $46.6m, burned $36.6m cash in 2010
Entereg Notes
- 2010 Entereg revenues increased 74% over 2009 ($25.4m net sales 2010)
- But 4q2010 growth rate quarter over quarter was only 12%
- Annual Entereg sales on $30m run rate.
- Further growth in sales is expected in 2011 but won't give guidance
- Current run rate is roughly break even for Entereg after taking into account costs and $GSK profit share
- Entereg COGS was 11% for 2010, but this includes inventory at zero cost that was made prior to approval and expensed to R&D- so would rise eventually
- The 7000 patient outcome study that I summarized on the ADLR research page has been submitted as a manuscript for publication and will be presented at the May 2011 meeting of the American Society of Colon and Rectum Surgeons
- OIC condition experienced by millions of chronic pain patients who take opioid medicines- and there are no FDA approved drugs for this indication- this incentivized ADLR to use their past unsuccessful experience with Entereg in OIC to re-enter the space
- Phase 1 OIC results: both ADL5945 and ADL7445 were safe and well tolerated at therapeutic doses [but these data have not yet been presented]- meaningfully increased the number of bowel movements per week
- ADL7445 has been designated as a backup compound, and ADL5945 advanced for the time being
- ADL5945 phase 2 studies have 40 pts per arm, 200 pts total looking at once and twice daily dosing, and these studies are powered such that ADLR believes a successful p value would correspond to a clinically meaningful improvement
- Project OIC results 3q2011 and initiate phase 3 program in 2011
- No comments on partnering
- Said had completed phase 1 trial of beloxepin (ADL6906) for pain but gave no more discussion
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