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Summary
conference date: May 9, 2006
for quarter ending: March 31, 2006 (1st quarter)
Overview: Nothing has changed; the fate of the company is dependent on whether the FDA approves the BLA for Provenge that Dendreon expects to file some time in 2005. In the meantime they are burning cash like crazy, $28.3 million this quarter.
Basic data:
Cash and equivalents ended at $138.1 million.
Net loss was $24.4 million or .34 per share. Included $801,000 stock-based compensation.
Guidance:
$100 million net cash burn in 2006. Optimistic on BLA submission.
Conference Highlights:
Heard concerns about trading in stock and continues to believe the best path is to focus on submitting the BLA and preparing to manufacture Provenge when they get approval. Optimistic based on discussions with leading prostate cancer researchers. FDA agreed to wave the BLA application fee for Provenge.
Phase III trial that is not part of BLA submission, but continues to enroll patients.
BLA for Provenge is on track. CMC section (chemistry, manufacturing and control) is key limiting section of application. On track for meeting manufacturing setup completion date. Facility will support $1 billion in annual sales. Recombinant antigen component outsourced contract is going well.
Compelling survival advantage, safety, does not guarantee FDA approval, but it is quite likely based on experience.
Q&A:
Budget for facility? $8 million for New Jersey facility.
Continency plan if FDA asks for further data? Does have other trials in progress, but confident of application with current data.
Confidence basis over last 3 months? As BLA is assembled shares with outside advisers, many of them are former reviewers for FDA. CMC progress also important.
Has developed a good test for potency of the product; shows up in trial statistics.
Modularization of manufacturing buildout was due to capital conservation considerations; original facility is sufficient for commercialization.
FDA panel composition has not been determined, but hopes to know which committee before BLA is submitted.
Will partner outside US, but only after it gets a decision from FDA.
Will you be able to launch without raising additional money? Will be opportunistic.
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Disclaimer: Our analyst summaries may include both our condensations of statements made by company representatives and our own analysis. They are not covered by any warranty. We cannot guarantee anything said by company representatives is true. Before making or terminating an investment you should always verify any factual basis of your decision from multiple independent sources.
Copyright 2006 William P. Meyers