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ANSV
Anesiva
conference date: May 8, 2007
for quarter ending: March 31, 2007 (1st quarter)
Overview: Waiting for FDA approval of Zingo and continuing pipeline development.
Basic data:
No revenues were reported.
Operating expense was $12.7 million, including $2.0 of stock based compensation. Year-earlier operating expense had been $15.5 million
Net loss was $11.7 million.
Interest and other income was $1.0 million
Cash and equivalents ended at $71.7 million, down from $85.1 million on December 31, 2006.
Guidance:
For full 2007 net loss of $55 to $60 million plus non-cash stock compensation of $9.0 million.
Cash and equivalents to end between $30 and $35 million.
No revenues are projected.
Conference Highlights:
End of 2007 cash includes anticipated new $15 million loan for manufacturing equipment for Zingo.
Zingo for childen new marketing application was accepted by FDA in February 2007. Expect to get answer from FDA this fall. Filing will allow for International approval, but will seek partners for sales outside the U.S. Current Phase III trial is Zingo for adults. If data is positive will file a supplimental application with FDA. Sales and marketing group continues to prepare.
4975 for severe pain had positive data for Phase II trial for knee replacement surgery. Showed analgesia even after systemic detectibility in plasma. Two areas going forward: osteoarthritis and post surgery. Three Phase II trials will be for knee surgery, hip replacements, and arthroscopic shoulder surgery. A phase III trial for knee replacement surgery will begin this 2nd half of year; one for osteoarthritis will begin in the 2nd half of the year.
Q&A:
Why both a Phase II and Phase III trial for knee replacement? Want to try higher dose in Phase II; believes may be more effective at higher dose. Will roll that into the phase III trial, which will have 3 arms: placebo, low dose, and high dose.
Endpoints? Reduction in pain scores in various time frames. Reduction of opioid use is not an impoint but may influence FDA decision.
$15 million loan? Expects to execute that in Q2. 24th of September is date for end of FDA answer period.
What about other indications where you got good results? It is a question of focus. Are talking to potential partners; may move other indications up if they get a partner. Looking for international partner and also a U.S. partner to supplement sales effort.
Expenses going forward? Because of new trials expenses will escalate during the year.
Partners? Osteoarthritis, if approved, would require a much larger sales force than Anesiva plans. Need someone with a sales force experienced in that area.
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Disclaimer: Our analyst summaries may include both our condensations of statements made by company representatives and our own analysis. They are not covered by any warranty. We cannot guarantee anything said by company representatives is true. We try not to make errors, but its possible. Before making or terminating an investment you should always verify any factual basis of your decision.
Copyright 2007 William P. Meyers
