conference date: August 7, 2007 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2007 (2nd quarter)
Overview: Waiting to complete new Dendreon trial, buring cash all the while, but has enough to see if interim trial results come in positive.
$0.5 million in revenue.
Net loss $22.2 million, less than the $25.1 million in 2006. EPS negative $0.27.
Cash and equivalents ended at $143.7 million, up due to $85 million from convertible senior subordinated notes offering.
Operating expenses were $23.4 million, reduced from $26.3 million year earlier.
During quarter received confirmation from FDA that it will accept either a positive interim or a positive final analysis of survival from IMPACT study to amend its BLA for Provenge for metastatic, androgen-independent prostate cancer.
Enrollment in IMPACT continues, expects completion of enrollment this year. Expects to have interim results in middle of second half of next year. Believe there is a reasonable chance they will be positive and sufficent to get FDA approval to market. Final results from IMPACT trial will not be available until 2010.
We are now processing all our clinical prossesses in house, which will reduce costs. We are talking to potential partners for regulatory approval outside the United States.
Data from prior Phase III studies (D9901 and D9902A) analysed to show prolonged survival benefit for patients initially treated with Provenge who then received docetaxel chemotherapy after disease progression.
FDA approval critieria for cancer are now being debated in the press.
Not all the $85 million has showed up on the balance sheet. $82.4 million net. Balance will appear in current quarter.
The $0.5 million revenue came from sale of intellectual property.
Expects cash expenses to be $95 million for year. Next year expects mid $50 million in cash expenses. $20 million of 2007 expense is inventory-related purchases, expense should not recur next year. New Jersey facility buildout is complete.
Update on enrollment? No specific numbers, but enrollment is strong and should be completed by end of year?
Interim analysis patient expansion? Would have to get FDA to agree to it, but it is possible.
Manufacturing issues identified by FDA? They are well in hand.
Pipeline? Are prioritizing pipeline, will give clarity on this later. Could study Provenge in earlier stage of prostate cancer. My also develop other products.
Survival data color? Most relevant endpoint. Power is based on hazard ratio from earlier studies. Study is reasonably powered to achieve success. Hazard ratio is treatment effect over entire length of study.
Frozen Provenge for patients that progressed? Patients in placebo arm that have disease progression are allowed to take frozen Provenge.
Not saying that progression is not related to survival. In one study 31% decline in disease progression versus 41% decline in morbidity. Believe overall survival is best endpoint.
Confirmed full 2008 spending range will be reduced to mid $50 million.
Believes will have plenty of cash through end of 2008.
What if you have positive results in 2008? No, we will have to spend more if interim results are positive.
There is an informal inquiry from the SEC taking place. They don't necessarily give feedback on this type of inquiry.
Europe strategy? Will not comment until we have a definitive answer from regulatory authorities.
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