New York, NY (
) -- I'll be covering
investor meeting today.
A nice idea: Dendreon is taking investors on a tour of its New Jersey manufacturing plant after the meeting wraps up in New York. Provenge manufacturing has been one of the Street's concerns, so taking investors out to the facility to see first hand how the prostate cancer immunotherapy is made is a smart way to dispel any fears.
Dendreon CEO Mitch Gold said the company will file Provenge with the Food and Drug Administration in mid-November, a refinement of its broader fourth-quarter filing guidance. The company did not announce a European partnership this morning, in line with expectations.
Update at 10 AM EDT
Dr. Charles Drake, an immunotherapy expert at Johns Hopkins' Kimmell Cancer Center, discussed the basics of cancer immunotherapy, which uses a patient's immune system to target and kill cancer cells.
Drake said his preference would be to use an immunotherapy like Provenge earlier in the course of a patient's prostate cancer, when the tumor burden is lower. That's potentially positive for Dendreon because it would open up Provenge to a larger pool of patients.
Dr. Mark Frohlich, Dendreon's chief medical officer, discussed the phase III Provenge data that was presented last May. You can find my write-up of that data
. He didn't present any new or updated data.
Frohlich also talked about future or ongoing Provenge studies, especially in patients with early-stage prostate cancer.
Dr. David Urdal, Dendreon's chief scientific officer, spoke about how Provenge is made. "Can we make this product? I'm here to tell you that yes we can," he said.
A video was shown demonstrating the supply chain for the manufacturing of Provenge. The company has developed a proprietary software system dubbed Intellivenge, which coordinates the Provenge manufacturing process and helps track each dose of Provenge from the doctor's office to the manufacturing plant and then back to the doctor's office.
Intellivenge knows where each Provenge dose is in the manufacturing process, so that patients can track their own Provenge through each step of the process, said Matt Kemp, Dendreon's senior director of marketing.
"Patients will be able to track Provenge from their home computers like they track a FedEx or UPS package," he said.
Update at 10:20 AM EDT
Dendreon CFO Greg Shiffman said the company expects first full-year Provenge sales in the range of $60 million to $125 million. That assumes a Provenge launch in the middle of 2010 from the New Jersey manufacturing plant operating at 25% capacity.
Shiffman called this early sales ramp similar to other novel cancer drugs.
Beyond 2010, when the New Jersey plant is built out to full capacity and the new plants in Atlanta and Los Angeles are completed, the company will have capacity to support Provenge sales in the range of $1.2 billion to $2.5 billion.
It looks like the Dendreon meeting was a sell-on-the-news event. The stock is down 6-7%, likely because the company did not make big news here. The FDA filing is still in process and the company did not announce a European marketing deal. The stock's run-up into today's meeting likely lifted investor expectations for headline-grabbing news too high.
I've followed Dendreon for a long time, so I think I know the story fairly wel. With that said, the company has not said anything at the meeting so far that veers from previous guidance.
Update at 11:10 AM EDT
Dendreon CFO Shiffman clarified further his Provenge guidance, stating that the $60 million to $125 million represents maximum revenue forecast for the first six months of the launch, assuming a mid-year 2010 launch from the New Jersey facility operating at 25% capacity.
Provenge "revenue will ramp substantially as manufacturing capacity comes aboard," he added.
The stock has recoverd somewhat, now down 4%.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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