Conference date: August 11, 2009 @ 8:30 AM Pacific Time
for quarter ending: June 30, 2009 (second quarter)
Overview: Main news is a large non-cash charge and the preparations being made to manufacture Provenge.
Basic data (GAAP):
Revenue was $25,000.
Net loss was $126.7 million, substantially more than the loss of $16.5 million year-earlier.
EPS was negative $1.20, compared to negative $0.18 year-earlier.
None. [It will take some time to get FDA approval and show revenues.]
$150 million cash use for full year 2009. Expects about $200 million cash balance at the end of 2009.
Ended with cash balance $287.5 million, of which about $221 million was from the May stock offering. $58 million of cash was used in the first half of 2009.
Operating expenses were $20.9 million, but there was a non-cash charge of $105.8 million for the revaluation of warrants. This is due to the increase in stock price.
As previously reported, the IMPACT study for Provenge for advanced prostate cancer demonstrated statistical significance for overall survival. Dendreon intends to amend its BLA (Biologics License Application) to the FDA before the end of this year. The FDA will have up to six months to review the application. Hopes commercial launch of Provenge will take place in first half of 2010. In addition, and integrated analysis of the D9901 and D9902A Provenge study also demonstrated a survival advantage.
Following the good data, approximately 12 million new shares were issued at $19.20 per share, raising $221 million.
Construction of the remaining capacity for Dendreon in Morris Plains N.J. and is planning facilities in Atlanta and Orange County.
Discussions with potential customers for the commercialization of Provenge outside the U.S. are underway.
Plans to obtain commercial quantities of raw materials for the manufacture of Provenge.
Use of cash over the next year? A large portion of the New Jersey build out will be in the cash use we gave for 2009. The other facilities will start requiring substantial cash in 2010. We do not expect to need to access the capital markets again, certainly not before a decision by the FDA.
Meeting with the FDA? We are in continuous and constant dialog with FDA. At May meeting they confirmed that the IMPACT results were sufficient to amend our application. We also went through the complete response letter of 2007 item by item, so that we could address items in the amendment.
Partnering plans? No change. We will commercialize in the U.S. Outside the U.S. we are in active discussions, and will not comment further.
New direction with platform? Will go over that in detail on analyst day in September.
In the future all the Hazard ratios will be reported in less than one format, which is becoming the industry standard.
The $20 million payment for the antigen is a current payment, but when we receive the antigen it may be reclassified as inventory. We paid about 50% up front and will pay the rest on delivery.
The Atlanta and LA facilities will be slightly smaller than the New Jersey facility.
Pricing? We are seeing no changes in pricing strategy due to current health care reform efforts.
There is already over 90% brand recognition of Provenge by physicians today.
It will be a rolling submission. The amendment will be larger than the first BLA because we have so much more data.
Publication data? We plan to publish in a peer-reviewed journal; we will let you know.
Headcount? Around 270 today. We are actively recruiting for a sales head.
Dendreon Main Page
Dendreon corporate investor page
Analyst Conference Summaries Main Page