conference date: August 8, 2006
for quarter ending: June 30, 2006 (2nd quarter)
Overview: Still waiting to file for approval of Provenge with the FDA. Not a stock for the feint-of-heart. But they are spending money with great confidence and seem confident of FDA approval.
Revenues of $78,000.00 against operating expenses of $20.1 million. Net loss of $18.8 million or .26 per share.
Cash ended at $105.6 million.
$15.6 million of expense was attributed to R&D.
Guidance: Will use approximately $100 million cash in 2006 overall.
Reiterated recent mile markers for Provenge, including publication of one Phase III study on Provenge in a journal, completed building the manufacturing facility, and publication of a Phase II study of Provenge+Avastin.
On track to submit Provenge to the FDA for a license later this year . Has been having a "collaborative and productive dialogue with FDA." Will do a rolling submission (BLA) starting next month. Facility must be approved by FDA, in addition to getting approval for the drug itself. Plans to submit clinical portion of BLA this month, for the CMC (manufacturing) portion later this year.
Antigen conformance is very important to BLA; must prove can manufacture quality product at a consistent, commercial scale. Must show that material produced in new plant is the same as what was used in clinical trials. Conformance runs are completed.
Trp-p8 small molecule partnership was abandoned by Genentech. Believes it is a good program, now DNDN owns 100% and will continue to develop it and seek new partners.
Capital expenditure will decline in second half of year; was front-loaded for year.
NP11 study safety record is allowed to be incorporated for Provenge safety approval.
Continues to talk to possible partners both for US and outside US. Won't make an agreement until after FDA approval.
What if you get an approvable letter with conditions? FDA said survival benefits and safety would be sufficient to approve.
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Copyright 2006 William P. Meyers