Dendreon hosted a painful conference call today, and despite management answering most questions you could hear some frustration and disappointment out of management. The FDA has requested additional data but not specified what form of data. The impact study is double blind and placebo controlled Phase III study under a binding FDA agreement. This will serve as the basis and they will complete and interim analysis next year and a final analysis in 2010.
The company is maintaining that they are committed to this process. As far as earnings for the quarter, but earnings are irrelevant because revenues were a whopping $80,000.00. It had $88+ million cash and equivalents at the end of the quarter and they think the cash is adequate to get them through to interim analysis in 2008.
Please continue reading further because the list goes on and some people jumped back in the line to ask questions. These are brief summary comments rom the Q&A session and some of the answers and questions were only able to be partially caught:
JMP Securities: How did FDA attitude change since the panel?Discussions didn’t change and there was very little interaction withthe FDA. As far as discussions, the study is a binding writtenagreement and based on preliminary discussions there may be somealternatives down the road. As far as the burn rate, will they haveheadcount reductions? They are taking appropriate actions to preservecash but they are not sharing details yet.
Monene??? Is there a more formal process to discuss this? Yes, butthey can’t give any timing on FDA end. Does company have the option of"appealing"? yes, but they are not considering that path right now.The company did say they will need to do a financing before a
B of A? on the purchase of the antigen having a shelf life? Yes, butit is in years. What can the company do to reduce the cash burn? Thewon’t be gearing up and they will give an update soon.
Lazard. Is it fair to think the delta is in line in treatments?Likelihood that survival is small? no, the study started in 2003 andthe drug takes effect between 8 & 13 weeks. If the 400 patientsare having 2 year survival rate why will it take to 2010 to have fulldata? It is because patients enroll at different times aqnd they onaverage live 18 to 20 months. At 3 years there were still some alive.
UBS. As far as manufacturing and responding to FDA? They do not thinkthe issue is over manufacturing. They hoped to have that inspection onFEB 12 and they are addressing observations made at the time. Theystill need to complete data but they don’t see manufacturing being anissue. The manufacturing observations are not big issues. Is thesafety a concern or is it efficacy data? Efficacy.
Next Generation Equity Research. What is basis of analysis? based onnumber of death events. They arent disclosing the actual numberthough. Results are identical on cross-over rates. As far ascommitments $12.5M for the year.
Biotech Stock Research. As far as ramp of enrollment for trials, itwas 150-200 in JAN 06 and 300 in NOV, now 400? Is that right? Companywasn’t able to confirm because data isnt in front of them. When thecompany amended the trial, did the company anticipate a change ofsurvival rates? The rates were similar and in-line between Phase IIand IMPACT study. Do you have ASCO presentations and AUA conferences"Yes, data coming out at both. There were no potency issues? No.
McAdams Wright. Detail on death event and interim analysis, was the99.01 equivalent to interim? The death event was more, but I didn’thear which one. Survival is still 18-20 months and that is taken intoconsideration. As far as partnering outside the US, they wouldconsider.
JMP Securities, follow-up question. Can you walk me thru the data onresults? go to data and look at 160 death events for 99.01 and .02a,the B study will have a similar or "more" death events. The FDA hasagreed to interim analysis and goals, but won’t get spe
UBS follow-up. SHELF REGISTRATION…When will it be used? It iseffective, but the company does not have any specific plans right now.They do expect to tap the market at some point before interim, but asfar as 2007 or 2008 they won’t speculate on which it is. As far asother opportunities? they wont be specific but they are exploring otheroptions.
B OF A follow-up. Does it have a delayed survival effect? no.
Biotech Stock Research (follow-up). Any new pipleline activity? They will review but that is not now during cash review.
CONJECTURE: The company answered most of the questions asked, but thequestions were really not the hard questions. It does not sound likethe company is signaling that they plan to unload shares or debt on themarket in the immediate future. By the sopund of it investors shouldprobably expect a securities sale toward the end of the year if thecompany doesn’t get "other financing" from non-traditional means; butthat statement is purely opinion and using experience to judge astatement by the company. Sorry for the dropping off of names or onlypartial questions but some of these were either hard to hear or wereunclear. Shares of Dendreon closed down 12% in normal trading at $5.54and shares are down 5% at $5.25 in after-hours trading.
Jon C. Ogg
May 10, 2007
Jon Ogg can be reached at firstname.lastname@example.org; he does not own securities in the companies he covers.