Conference date: August 3, 2010 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2010 (second quarter)
Overview: First revenues from Provenge give glimpse of future.
Basic data (GAAP):
Revenue was $2.8 million, the first significant revenue.
Net income was negative $142.6 million. It was $126.7 million in the year-earlier quarter.
EPS (earnings per share) were negative $1.04. It was negative $1.20 year-earlier.
Will treat 2000 patients during first 12 months after launch.
For full 2010, $460 million cash will be used, excluding revenues. $215 million plus any revenues from Provenge should be left at the end of the year.
First significant Provenge for prostate cancer (asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer) revenues. Over 500 prescriptions received through the end of July. May saw the commercial Provenge launch.
In July, after the quarter ended, revenue was $5.2 million.
Positive coverage guidelines have been established by Medicare and private payers. Demand is strong, with waiting lists to receive Provenge. About 50 sites are working with patients.
Expansion of manufacturing facilities is on track.
Loss for the quarter included a $0.55 per share charge for warrant revaluation.
Cash ended at $492.4 million, dropping rapidly.
A National Coverage Analysis (NCA) is being conducted for Medicare CMS on Provenge. Local Medicare Administrative Contractors have been approving coverage already. However, a decision, positive or negative, would have to be covered by all Medicare locals. Only one region has denied coverage so far.
Cost of revenue was $2.7 million. Operating expenses of $68.4 million included $20.7 million for research and development, $47.7 million for general and administrative. Non-cash loss from valuation of warrants was $74.5 million. Warrants converted to stock, so going forward there should be no more gains or losses on them.
Pivotal IMPACT study data published in the New England Journal of Medicine.
In July New Jersey plant was shut down for 10 days to facilitate expansion. Ran at nearly full capacity by end of July. Expanded capacity should come on line in early 2011.
Still believes will treat 2000 patients during first 12 months after launch.
Gross margins will improve as revenues ramp. Cost of goods sold should be in 30% range in 2011 and drop to 20% range when all facilities are operational.
Dialog with CMS? Have been talking to them, will continue. The positive coverage analysis from most of the locals is a good indicator.
Number of patients vs. infusions? Most go to 3 infusions. But some infusions may follow prescriptions by over a month. 500 prescriptions includes patients that have not yet been treated. It does not include patients on waiting lists.
EMEA timeline? In discussions, no timeline to announce yet.
Prescriptions from non-approved sites? Not taking from outside our network. But we are talking to possible new sites.
Capacity versus July revenue? Will not name exact NJ capacity. Currently at 25% of planned capacity. Did not utilize full capacity in July. Number of patients so far is limited by need to work with sites and reimbursement questions. No more shutdowns for NJ are planeed for 2010.
$31,000 per infusion, divide that into revenues and you will get the number of infusions.
Geographically, the western part of the country had demand ramp up to the east more quickly than expected.
Failure rates for manufacturing process are about the same as were seen during the clinical trials.
When NJ is built out it should be able to generate $500 million to $1 billion annual revenue.
We feel we have the cash to reach cash flow break even in the U.S. To put in infrastructure in Europe we would need capital to act quickly.
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