conference date: May 4, 2006
for quarter ending: March 31, 2006 (1st quarter)
Overview: This is a biotech company specializing in pain relief with of its drugs nearing (it believes) regulatory approval. It burned $14.8 million in the quarter getting ready to file a NDA (new drug application) and developing its pipeline.
Cash on March 31, 2006 was 80.1 million; burn for the quarter was $14.8 million. There are 20.1 million shares, so $4 cash per share. Universal shelf filed to become effective next weak, so expect share dilution as cash is raised.
Operating expenses were $15.5 million. Net loss was $14.6 million. There was no income excepting interest income.
2006 losses of $45 to $50 million before non-cash compensation. Ending cash $35 to $40 million.
The company name will be changed to Anesiva.
Plans to self-market its pain drugs direct to hospitals through a specialty sales force.
On 3268: working on Common Technical Document type NDA, which should be internationally acceptable; hopes to file this summer. Doing further market research.
On 4975: effectiveness has been shown in several trials for surgical patients and tendinitis of the elbow. Working with FDA towards final trial plans.
1207 near Phase I trial (large-scale topical pain).
Run rate for R&D of $9 million continuing? Future months will be down slightly. Several people were let go from both companies [merger completed last fall], so costs including stock compensation will be going down.
NDA filing point? Mid-2006 and summer are synonymous; not behind schedule.
4975? Its Phase II trials have proven it to be an effective and durable pain killer for moderate to severe pain. But not successful when pain is less than moderate because then it requires larger sample sizes to notice slight differences in perceived pain.
1207? Will be focused on chemically or biologically induced neuropathy.
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Copyright 2006 William P. Meyers