Vertex (VRTX) released their 3Q07 numbers yesterday and hosted a teleconference for investors. Here is a link to a transcript:
Their R&D expenses were up but they still expect to hit their overall FY numbers. The only new news on Telaprevir was that—as expected—they are in discussion with the FDA concerning the definition of their phase 3 study, but disappointingly, management were unwilling to discuss any sort of time frame at this stage. Given that it is practically November, it is now evident that there will be no phase 3 launch this year, as previously hoped…and management’s sudden reticence to discuss timing gives one pause as to the likelihood of a launch early in 2008. A substantial delay translates into a delay in potential approval, which in turn means a delay in potential revenue and black ink, which in turn translates into a lower present day valuation, given the need to discount the risk over a longer time frame.
Meantime, new Phase II interim efficacy data are due out in the next week (to be presented at the 2007 American Association for the Study of Liver Diseases conference in Boston starting this Friday). Final efficacy and safety data are expected sometime in 2008; if the FDA want to see those before settling on a plan for the phase 3 study—which normally would make sense but expectations here were that we could speed things up given the robustness (1000 patients) and stellar interim results of the phase 2 trials—we are probably looking at a delay of a year or more here.
There was some discussion of a new anti-HCV compound and also a potential anti-cystic fibrosis compound, but both of those are very early days.