Conference date: February 22, 2010 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2009 (fourth quarter)
Overview: Getting everything ready for (hopefully) FDA approval of Provenge for prostate cancer by May 1, 2010. So lots of expense, no revenue yet.
Basic data (GAAP):
Revenue was $21,000.
Net income was negative $32.5 million, improved sequentially from negative $45.6 million, but worse than the negative $8.8 million in the year-earlier quarter.
EPS was negative $0.28, improved sequentially from negative $0.40, but worse than the negative $0.09 year-earlier.
If Provenge is approved 2010 will be a significant cash investment year for Dendreon. If there is revenue in 2010 it will be from Provenge manufactured in existing New Jersey facility, which will have a very approximate capability of $500 million annually. $200 million in capital expenditures will be made in 2010. $30 million will be used to build inventory. 2010 GAAP operating expenses of $300 million if Provenge is approved.
2011 should be a cash flow positive year if Provenge is approved and facilities are completed and opened on schedule in mid-2011.
Provenge (sipuleucel-T) PDUFA date is May 1, 2010, so we would expect to hear whether FDA is approved for commercial sales by that date.
Total operating expense of $36.4 million consisted of $20.0 million for research and development and $16.4 million for general and administrative. Interest income near zero. Gain on valuation of warrant liability was $4.0 million.
Cash, investments and equivalents balance ended at $606 million. Warrant liability is $133.0 million. Convertible senior subordinated note debt is $52.5 million.
$409.5 million net was raised by selling common stock in the quarter.
Dendreon accelerated the building of the Atlanta, and Orange County manufacturing facilities. They are scheduled for opening in mid-2011. Provenge will be launched from New Jersey facility, which also will be built out.
IMPACT study data will be published at science conferences throughout the year, including one next week.
Working on advancing more ACI (active cellular immunotherapy) candidates, at a rate of about 1 per year.
Now almost 500 employees.
Commercial plans for sales force in U.S.? Dendreon is actively preparing for launch and is hiring sales management people. We will be ready by the PDUFA date.
FDA inspection of New Jersey plant? We are in continuous dialog, will not give out details.
Cost of goods sold, SG&A and R&D costs will be allocated as we get closer to actual operations.
There has been no indication that we would need to go to an FDA panel meeting before final approval.
European sales? That is a more distant event, because we would have to have manufacturing facilities that could support it. If it makes sense to shareholders, we would to it ourselves, else we would do something also. Launch outside the U.S. is probably several years after the U.S. launch. We are in vigorous discussion with a number of parties. Logistics in Europe are very similar to what we have in the U.S.
We can launch the next day after approval.
Reimbursement strategy? Median age in IMPACT study was 71 years of age, which is clearly in Medicare population. We have initiated discussions with other payers.
Both men who had pain, and those without pain, showed survival benefit in the IMPACT trial.
Pricing guidance? No, but cost of goods sold will start at above 30%, but should drop to in the 20% range as we get to reasonable volumes, allowing us to have a good model comparable to other biologics.
If we get approval before the PDUFA date, we would launch as quickly as possible.
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