Catalysts for Vertex rallies in the coming several months
Form 10-Q is loaded with good information. The numbers quoted below are from Form 10-Q.
1) FDA approval of Kalydeco use for non-G551D gating mutation will be coming at any moment now. The data were better even compared to that on 551 mutation. The number of patients benefit from this label expansion is 400 according to Form 10-Q.
2) Ph III results for Kalydeco on R117H will be reported within the next several weeks. The data will be good and an sNDA for this label expansion will come in early 2014. The number of patients benefit from this label expansion is 1100 according to Form 10-Q.
3) Data from pediatric formulation of Kalydeco for 2-5 year olds with all gating mutations (300 in this group) are due in Q2 2014, and NDA is scheduled to be in H2 2014.
4) Kalydeco data for residual function mutations are due in Q2 of 2014. There are additional 3000 CF persons who will benefit from this label expansion. There are plenty of anecdotal evidence that the results will be positive.
5) Form 10-Q again says that the data from VX-809/Kalydeco Ph III will be coming in mid-2014. I think the date will be just before the ECFS meeting (June 11-15) where they could be presenting a Presidential Plenary talk. But some preliminary data could come much earlier, triggering a mammoth rally. An approximate number of homozygous 508 CF persons who will benefit from this combo is 28,000. The Kalydeco revenues from this combo could reach 5 billion annually adding to the 1.5 billion from Kalydeco-monotherapy responsive indications, earnings per share reaching 20 dollars each year beyond 2015.
6) Data from VX-135/Daclatasvir will also be released in early next year. I speculate that the data will be spectacular. The earnings from VX-135 could reach 1 B eventually. Long time ago, an RBC analyst estimated that the success of this combo can add $10 to the share price, but you know that is too low. If this combo is as good as the Gilead’s best, annual revenue could reach a few billions.
Nice post Third. Taking a hard look at your post and some prior posts by bootpart might be a good idea I think. My speculation is that the next news won't come until December... and this might be cynical, but I would take a shot at it being on or around the same day Gilead gets their approval.
DFC, you are right. The results from VX-661 + Kalydeco trial for CFers with G551D in one allele and F508del in the other allele will also be reported soon. If the in vitro result is translated in clinic, it will be spectacular. A paper says 72 % of 551 CFers have F508del on the other allele.