Dendreon Conference Call Transcript Summary & Commentary
by Jon C. Ogg
24/7 Wall St.
Dendreon (DNDN) spoke on a planned conference call this evening that was moved to 6:30 PM EST rather than the 7:30 PM EST planned time. They probably had a major steak dinner and 12 cases of champagne to get to. I know I would if I was them. This was on the favorable outcome out of the FDA Panel Review for its Provenge(R) for the late stage patients suffering from advanced prostate cancer. The company noted the evidence of safety and efficacy, and Provenge will provide the treatment that extends survival t these patients. Dendreon says will be working with FDA and the PDUFA day is currently May 15. Please pardon the lack of names because it was hard to tell who was speaking inside the company to analysts.
We note here the name of the firm asking the question, and then we have noted the questions with the answers. This was taken in notation format since it was a summary, so you will have to see the “question” or “ask” and then get the answer that follows it. Here goes:
JMP Securities analyst: As far as commercial plans and launch here and abroad?
The company said that they can launch it themselves here. They expect a decision by May 15 PDUFA date and will go from there. The other study is 400 patients enrolled. As far as looking at this in models for number of patients???? The company noted it is 98,600 men and there are 50,00 in the target in the US; in Europe they think it is similar but it isn’t known in Asia. As far as “additional data submissions” on manufacturing???? They had the FDA inspect the facilities and they are still being discussed before PDUFA date. Analyst admitted he had some champagne, funny and then asked about sales force: the company said they can handle 125 individuals and they can manage it.
Biotech Stock Research (David Miller), newsletter writer that has been positive on DNDN: As far as when they are pulling the trigger, but they didn’t really say much. As far as giving thought to “FDA saying go ahead and marketing”?? They are completing the “IIb study” and are still discussing with the FDA. Is there a chance for a label of “for Caucasians only”? The co. says they are discussing that with the FDA but they don’t see a difference biologically in prostate cancer. Company says enrolling minorities had similar profile but admitted difficulties. On the Shelf Registration and Timing? The company said it is preliminary to talk specifics but they said as they get more feedback that they WILL require additional funds. (For conjecture, it was hard to tell if the company meant they would wait until the PDUFA date of May 15 before they announce a share sale or if they would do it sooner)
NEEDHAM Analyst: With 400 patients enrolled in the IIb, do they know when they will see more results? The company is maintaining again they will complete enrollment. The company would not predict the exact outcome, but the FDA has so far given the right indications and the patient community was clear in wanting a new treatment. As far as what the answers WILL and CAN be from FDA: company is pleased today but won’t predict the outcome. In New Jersey plant how many patients can they treat: they still don’t know until the FDA PDUFA.
Bank of America analyst: As far as panel members and association with politics inside FDA…company won’t comment there on politics inside FDA. (it sounded like company is working with the more favorable group, or so they inferred)
UBS analyst: As far as numbers of enrollments inside impact study seeming less than 200 in Provenge arm and 100 in placebo group? The co. said the actual number was 400 patients and that wasn’t shown in a slide. The will show 360 death events the estimate to show by or in 2010. The company won’t show a pre-specified look at IIb results.
Lazard substitute analyst: What is the risk that PDUFA date decision will be different because of different dates? Company said the wording was changed by FDA and any confusions were from the wording the FDA used. The company won’t speculate as far as certain outcome, but again said FDA usually follows its panel recommendation.
McAdams Wright Ragen analyst: On the FDA meeting being 8 hours long and an indication of what got them over the goal line to panel backing? Co. says the presenting team did a great job and they made this happen. The survival data carried the most weight AND the comments from the patient group made a huge difference. As far as FDA meetings ahead and guidance on cash burn? The company will update that as they know more. Question on whether investors should watch for most pertinent news out of the company or out of the FDA? The company says they will communicate the bulk of the data and they try to keep that up as they have been a constant communicator.
Lazard (main) analyst: As far as questions the panel asked in efficacies? The company said the first was 17-0 and the second was 13-4 and there may have been some difficulty in interpreting the question. Will the FDA ask additional questions or different questions? The company doesn’t know why they would but they won’t predict. On interim II study? The company will look at those and make them available when they have it.
The CEO said this was a historic day for prostate cancer patients and for the company. As far as our comment on this: “Yeah, you can say that again.”
CONJECTURE: As far as any conjecture on analyzing how the company did on their answers, this is fairly easy. I re-listened to the conference call to make sure on this, but all in all the company handled everything they could quite well. They were very straight and to the point on most of these, even though some of these answers were repetitive. There were not any classic tells shown of lying or highly selective omissions made by management. There is obviously not a riskless transaction, because there never is. But all in all it sure seems like the company and the community would seem to agree that this PDUFA date of May 15 will go in favor of the company. Is that an assurance? No way. The FDA does some strange things sometimes, and lately they seem more and more that way. Prostate cancer patients have more likely than not just made a new friend, and because of that there are some pretty happy investors today. Be sure to watch out for a secondary offering at some point, because while the company did put that off a bit they did say that they will need more cash to ramp everything up to proceed. And companies can change their stance quite rapidly, particularly if they get a massive jump in their stock prices. Watch out for this one tomorrow, because with the 200,000 to 300,000 of near months' expirations (April & May) open interest and the massive short interest of more than 30% of the float this one is going to be wild Friday. Does window dressing matter for that day? Maybe. Dendreon (DNDN) shares did not reopen today, so the trading will resume Friday. There is a chance that you can track this on Friday much earlier than would normally be available because the stock does actually trade in Germany under the "DNR" ticker in Frankfurt, BUT you will have to verify all that data and pricing for accuracy since almost everyone in the U.S. has delayed quotes for Germany. OK, it's been a 15 hour day on the desk, so good night..... and congratulations to Dendreon and to advanced prostate cancer patients hoping for one more possible treatment.
Source: 247WallSt.com
RELATED READING:
- Dendreon's Big Day: Favorable FDA Review, Wild Trading Day Tomorrow
- Dendreon's Last Day Ahead of FDA
- Dendreon: A Make or Break Week
- Dendreon: Trading Strategy Ahead of FDA Review
- Dendreon Interest Remains; Early Volume Surges
- Dendreon's Stock Activity Ahead of FDA Review
_____________________
24/7 Wall St.
Dendreon (DNDN) spoke on a planned conference call this evening that was moved to 6:30 PM EST rather than the 7:30 PM EST planned time. They probably had a major steak dinner and 12 cases of champagne to get to. I know I would if I was them. This was on the favorable outcome out of the FDA Panel Review for its Provenge(R) for the late stage patients suffering from advanced prostate cancer. The company noted the evidence of safety and efficacy, and Provenge will provide the treatment that extends survival t these patients. Dendreon says will be working with FDA and the PDUFA day is currently May 15. Please pardon the lack of names because it was hard to tell who was speaking inside the company to analysts.
We note here the name of the firm asking the question, and then we have noted the questions with the answers. This was taken in notation format since it was a summary, so you will have to see the “question” or “ask” and then get the answer that follows it. Here goes:
JMP Securities analyst: As far as commercial plans and launch here and abroad?
The company said that they can launch it themselves here. They expect a decision by May 15 PDUFA date and will go from there. The other study is 400 patients enrolled. As far as looking at this in models for number of patients???? The company noted it is 98,600 men and there are 50,00 in the target in the US; in Europe they think it is similar but it isn’t known in Asia. As far as “additional data submissions” on manufacturing???? They had the FDA inspect the facilities and they are still being discussed before PDUFA date. Analyst admitted he had some champagne, funny and then asked about sales force: the company said they can handle 125 individuals and they can manage it.
Biotech Stock Research (David Miller), newsletter writer that has been positive on DNDN: As far as when they are pulling the trigger, but they didn’t really say much. As far as giving thought to “FDA saying go ahead and marketing”?? They are completing the “IIb study” and are still discussing with the FDA. Is there a chance for a label of “for Caucasians only”? The co. says they are discussing that with the FDA but they don’t see a difference biologically in prostate cancer. Company says enrolling minorities had similar profile but admitted difficulties. On the Shelf Registration and Timing? The company said it is preliminary to talk specifics but they said as they get more feedback that they WILL require additional funds. (For conjecture, it was hard to tell if the company meant they would wait until the PDUFA date of May 15 before they announce a share sale or if they would do it sooner)
NEEDHAM Analyst: With 400 patients enrolled in the IIb, do they know when they will see more results? The company is maintaining again they will complete enrollment. The company would not predict the exact outcome, but the FDA has so far given the right indications and the patient community was clear in wanting a new treatment. As far as what the answers WILL and CAN be from FDA: company is pleased today but won’t predict the outcome. In New Jersey plant how many patients can they treat: they still don’t know until the FDA PDUFA.
Bank of America analyst: As far as panel members and association with politics inside FDA…company won’t comment there on politics inside FDA. (it sounded like company is working with the more favorable group, or so they inferred)
UBS analyst: As far as numbers of enrollments inside impact study seeming less than 200 in Provenge arm and 100 in placebo group? The co. said the actual number was 400 patients and that wasn’t shown in a slide. The will show 360 death events the estimate to show by or in 2010. The company won’t show a pre-specified look at IIb results.
Lazard substitute analyst: What is the risk that PDUFA date decision will be different because of different dates? Company said the wording was changed by FDA and any confusions were from the wording the FDA used. The company won’t speculate as far as certain outcome, but again said FDA usually follows its panel recommendation.
McAdams Wright Ragen analyst: On the FDA meeting being 8 hours long and an indication of what got them over the goal line to panel backing? Co. says the presenting team did a great job and they made this happen. The survival data carried the most weight AND the comments from the patient group made a huge difference. As far as FDA meetings ahead and guidance on cash burn? The company will update that as they know more. Question on whether investors should watch for most pertinent news out of the company or out of the FDA? The company says they will communicate the bulk of the data and they try to keep that up as they have been a constant communicator.
Lazard (main) analyst: As far as questions the panel asked in efficacies? The company said the first was 17-0 and the second was 13-4 and there may have been some difficulty in interpreting the question. Will the FDA ask additional questions or different questions? The company doesn’t know why they would but they won’t predict. On interim II study? The company will look at those and make them available when they have it.
The CEO said this was a historic day for prostate cancer patients and for the company. As far as our comment on this: “Yeah, you can say that again.”
CONJECTURE: As far as any conjecture on analyzing how the company did on their answers, this is fairly easy. I re-listened to the conference call to make sure on this, but all in all the company handled everything they could quite well. They were very straight and to the point on most of these, even though some of these answers were repetitive. There were not any classic tells shown of lying or highly selective omissions made by management. There is obviously not a riskless transaction, because there never is. But all in all it sure seems like the company and the community would seem to agree that this PDUFA date of May 15 will go in favor of the company. Is that an assurance? No way. The FDA does some strange things sometimes, and lately they seem more and more that way. Prostate cancer patients have more likely than not just made a new friend, and because of that there are some pretty happy investors today. Be sure to watch out for a secondary offering at some point, because while the company did put that off a bit they did say that they will need more cash to ramp everything up to proceed. And companies can change their stance quite rapidly, particularly if they get a massive jump in their stock prices. Watch out for this one tomorrow, because with the 200,000 to 300,000 of near months' expirations (April & May) open interest and the massive short interest of more than 30% of the float this one is going to be wild Friday. Does window dressing matter for that day? Maybe. Dendreon (DNDN) shares did not reopen today, so the trading will resume Friday. There is a chance that you can track this on Friday much earlier than would normally be available because the stock does actually trade in Germany under the "DNR" ticker in Frankfurt, BUT you will have to verify all that data and pricing for accuracy since almost everyone in the U.S. has delayed quotes for Germany. OK, it's been a 15 hour day on the desk, so good night..... and congratulations to Dendreon and to advanced prostate cancer patients hoping for one more possible treatment.
Source: 247WallSt.com
RELATED READING:
- Dendreon's Big Day: Favorable FDA Review, Wild Trading Day Tomorrow
- Dendreon's Last Day Ahead of FDA
- Dendreon: A Make or Break Week
- Dendreon: Trading Strategy Ahead of FDA Review
- Dendreon Interest Remains; Early Volume Surges
- Dendreon's Stock Activity Ahead of FDA Review
_____________________
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