conference date: November 15, 2007 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2007 (3rd quarter)
Overview: Uneventful, as Dendreon is waiting to complete its new Phase III trial of Provenge for prostate cancer. But some good Questions and Answers (see below).
Revenue was $0.1 million.
Net loss was $19.2 million.
EPS (earnings per share) were negative $0.23, an improvement from a loss of $0.29 year-earlier.
Cash and equivalents were $138.8 million.
Reviewed quarter's news: completed enrollment of Phase III IMPACT clinical trial of Provenge after receiving confirmation that the FDA will accept either a positive interim or a positive final analysis of overall survival to support the claim of efficacy.
A facility was created to sell up to $130 million of common stock to Azimuth Opportunity Ltd., but Dendreon is not obligated to use this facility or prohibited from other fundraising projects. But committed to operating Dendreon in a fiscally responsible manner.
Phase 1 results from Neuvenge for women with HER2/neu-positive breast cancer were published highlighting Neuvenge's safety profile, immune response and clinical activity.
Looking at European regulatory strategy.
Research and Develoment expense was $13.5 million; General expense was $6.3 million; total operating expnese was $19.8 million.
Expects cash expenses to further decrease in 2008.
Looking to expand pipeline in 2008.
Partnering discussion for international sales? Goal is to commercialize ourselves in U.S. and find a partner for outside U.S. Continuing possibility of partner, just evaluating international regulatory situation in parallel.
Neuvenge Phase 2? Completed two phase 1 studies (breast and colorectal). Discussing where to go with this and will be discussing with FDA. Will announce plans when we have them.
Data timeline for IMPACT? Guidance for interim results is for second half of next year. We are consistent with that timeline.
Will interim results be announced if goal is not met? We get back IBMC's analysis, so that will be available to the street. They will tell us if we have succeeded with interim, or bombed out completely (stop the study), or are doing well enough to go ahead to final despite not being good enough to win with interim.
Survival seems to be independent of Halabi scores. Demographics of patients seems to be the same as in the 9901 study.
Year end cash? Around $110 million.
Genetech partnership? We own the small molecule and are very excited; Genentech owns the antibody, but the antibody alone has not worked well against the TRIP marker.
Gleason score enrollments? About 60% is Gleason score 7 and below, 40% 8 and higher. Gleason score is a bit of a red herring since it has an impact on progression, but not survival. High-gleason score patients tend to do well with Provenge.
Interim analysis is pre-specified with a success endpoint. Will have more that 164 death events.
Taxotere (sp?) with Provenge, or other combinations? We showed when Provenge is given first patients do better than with taxotere alone. We believe immunotherapy can play well with chemotherapy.
Competitors in immunotherapy? Everyone is trying a different method. Ours has very specific targets, which we believe is the best way to go. We have data with Avastin that looks promising.
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