Release date: March 12, 2009 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2008 (4th quarter)
Note: There was no analyst conference. This data is from the press release. The next analyst conference will be when the Provenge IMPACT clinical trial data is released.
Overview: This amounts to a report on quarterly expenses, since the real question is whether Provenge data due in April will be positive, and if the FDA will approve the therapy based on the data.
Basic data (GAAP):
Revenue was $28,000, same as year-earlier.
Net loss was $8.8 million, compared to a loss of $27 million year-earlier.
EPS was negative $0.09, compared to negative $0.32 per share year-earlier.
None. [Even if Provenge data is positive, it will take some time to get FDA approval and show revenues.]
Ended with cash balances of $108.5 million.
The interim analysis of the IMPACT clinical trial for Provenge for prostate cancer showed a 20% reduction in the risk of death with a 95% confidence interval. The final analysis (which includes further data from the ongoing trial) is due in late April 2009. The 20% reduction in deaths is "encouraging" regarding the success of the final analysis.
The FDA approved an IND application to begin a Phase I study of D-3263 for cancer.
Research and development expense was $10.8 million, general and administrative expense $4.7 million. Interest income was negative $0.5 million. There was a $7.1 million gail from valuation of warranty liability.
The company has a liability of $85.3 million for convertible senior subordinated notes.
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