Conference date: May 2, 2011 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2011 (first quarter, Q1)
Overview: About as expected as ramp of Provenge machines did not get started until after the quarter ended.
Basic data (GAAP):
Revenue was $28.1 million, up 12% sequentially from $25.0 million, and up from essentially zero in the year-earlier quarter.
Net income was negative $111.8 million, down sequentially from negative $91.8 million, but improved somewhat from negative $125.7 million in the year-earlier quarter.
EPS (earnings per share) were negative $0.77, down sequentially from negative $0.64, but up from negative $0.96 per share year-earlier.
Full 2011 revenue guidance still $350 to $400 million. Half of that will come in . $330 to 370 million GAAP net loss for the year. Non-GAAP $230 to $270 million.
"Dendreon continues to expect revenue this year of between $350-400 million with approximately half of that anticipated in the fourth quarter." 36 new workstations at the New Jersey facility have begun to come online. This allowed April revenues to rise to about $15 million, well above the average monthly rate in Q1. 12 new stations should be online by the end of Q2.
The number of infusing sites rose to 135 by quarter end. Goal is 225 sites by end of Q2. Confidence of reimbursement is key to new accounts.
The Los Angeles and Atlanta manufacturing facilities have filed for FDA approval, with decisions expected in June and September, respectively. All 3 facilities should be manufacturing product by Q4 of this year. Manufacturing performance has been in line with expectations.
CMS final national coverage decision is expected June 30, 2011.
A European contract manufacturing organization has been selected. Filing with EMA on track for late 2011 or early 2012. A new global clinical trial is being designed.
Physicians and patients are excited about Provenge. Surveys show both oncologists and urologists expect to recommend Provenge to their patients.
Cost of revenue was $18.3 million, leaving gross profit of $9.7 million. R&D expense was $17.6 million. Selling, general and administrative expense was $95.3 million. Loss from operations was $103.2 million. Interest expense was $8.5 million.
$779 million cash and equivalents balance at end of quarter. $607 million raised with convertible bonds in January. $105 million cash used in quarter.
$26 million in non-cash expenses included in GAAP net income.
Cost of goods sold was elevated because of NJ startup costs, which preceded the launch of new workstations. Cost of goods sold should drop to 30% of revenue mid-term, then lower long term.
How many workstations expected working in NJ by end of year? Of 48, in Q2 we'll have 24 running on average.
24 stations means a cap for Q2 revenues? We could have more than 12 new stations running by the end of the quarter; the average for the quarter is 12.
Abiraterone for prostate cancer approval? We are happy to see more research and other therapies. We see Provenge as the foundation of care for these patients.
What limits the rate of utilizing the full 48 NJ workstations? We are staging the utilization of the stations because that keeps the quality high both for manufacturing and for physicians.
Why did number of infusion sites increase faster than revenue? Revenue did increase in April; before that adding sites did not help because we were capacity constrained.
Abiraterone at $44,000, will that effect Provenge in price-sensative European market? The data supports that Provenge has the largest reported survival benefit.
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