Conference date: November 11, 2009 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2009 (third quarter)
Overview: Spending money in anticipation of FDA approval of Provenge for advanced prostate cancer.
Basic data (GAAP):
Revenue was $25,000.
Net loss was $45.6 million.
EPS was negative $0.40.
Operating expenses were $25.8 million.
There was a non-cash charge of $19.4 million for revaluation of warrants. This is due to the increase in the stock price.
The BLA (Biologic License Application) for Provenge was amended and submitted to the FDA. The review process can take up to 6 months.
"We are working with the FDA to make Provenge available as quickly as possible to the many men who currently have few appealing treatment options."
More than 130 new employees have been hired since April.
$259.6 million in cash and equivalents remained at the end of the quarter.
Infrastructure for producing Provenge is being built out.
$150 million total cash usage for 2009 is expected. About $200 million cash balance is expected at the end of the year.
Will patients from the trials be eligible for boosters? There is evidence that boosters correspond to increased immune response, but we have no data on whether that improves outcomes. Patients who were in the placebo arms of the trials have been allowed to receive Provenge.
Number of employees target? Most employees hired are for manufacturing, some are for sales and marketing. We have over 350 employees. We expect to be at 550 to 600 when we begin commercialization.
EU partnership? Discussions are ongoing and are disconnected from our U.S. regulatory process. We are seeking an international partner to take Provenge through the regulatory processes outside the U.S.
We have received no information from the FDA that we are going to a panel; we will let you know if that happens.
Any reimbursement discussion yet? We have done a lot of work on reimbursement, but we will not make any specific comment on it yet.
Pricing? Our philosophy on pricing has not changed. We would expect it to be priced similar to other biologics that prolong survival.
Any details on FDA milestones and timeline? We would expect to receive notification from the FDA that they have accepted the application. We will be presenting addition data from the IMPACT study at future scientific meetings.
Are the facility expense going to be in capital expenditures, or in profit and loss? About 90% of the costs will be capitalized.
The current BLA only includes the initial 25% capacity of the New Jersey facility? Correct.
How will you deal with pent-up demand? Dendreon will not make these decisions, physicians will. However, the trial physicians will be first in line, then major academic centers, then gradually other doctors as they become qualified to administer it.
BLA filing date was October 30th.
Challenge to patents? We believe our patent position is extremely strong. We have multiple patents protecting our ACI platform, the antigen delivery cassette, and the manufacturing process. The patent being challenged is not considered to be vulnerable by us.
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