Usual request: please snipe at people in other items. G.d knows enough of them get started every day.
SOMEONE seems to have paid attention to the warnings against a repeat of Aug 2012; this was the antithesis of that. A couple of previously undiscussed candidates discussed. Revenue expectations gently nudged upward...
The color on the magic subgroup was interesting: it was one of 3 or 4 predefined based on mechanism. And YES, it will have to be disclosed before ASCO because it will be designed into future trials.
Color too on why they think the PV opportunity is so much larger than anyone else does: people like me paid attention to physician judgments of how successfully PV was treated; Incyte did an aggressive chart review and found that a lot of patients were acting as if minor residual illness was a big deal to them.
Incyte is a smallish company with [effectively] a short history and an appropriately smallish R&D budget...and a pipeline at least comparable to a pharma giant. Potential acquirers are salivating for sure, but not. I think, over the pipeline. They CRAVE the strategies that gave such a high yield of candidates (In outline it's obvious: pick juicy targets and understand them well before and during lead generation. In practice, that's only one baby step better than "buy low; sell high"). So I think the chance of a hostile bid is WAAAYY down. Only a living goose lays those nice eggs.
Let's see, what else? Was there a BoA question? I don't remember it, and they cover Incyte like the sky. Is dear Rachel still the coverage analyst? Also: note the lack of a kick in Jakafi sales; oncologists aren't flocking in...yet.
Couple more things worth calling out. We learned what the milestone is for Jakavi: pricing and reimbursement in three of the N (value of N doesn't matter) largest markets in Europe. I'm not sure how to count to three in this instance, but France and Germany are in place, Italy is manageable and the UK could come on board pretty much any time (NICE always rejects first time 'round, and that happened in February).
It was strongly implied by some of the wording that the message of longer MF survival if treatment is started very early has gotten through to the US physicians with several MF patients. For physicians with 1 or 2 MF patients, I'm less hopeful than management that they will be allowed to draw the conclusion on the label, but at least references to the extensions of the registration studies ought to be allowed.
Rachel McMinn asked three questions during the conference call that I can remember, the first regarding the IDO inhibitor study and what can reasonably be expected, PFS or response rates, from the dose escalation study with ipilimumab. This is clearly an area of intense interest to her and of course to
Incyte as combination therapy with a successful checkpoint inhibitor would have great commercial value. The data they will be presenting next year will be the combination response rate data vs historical ipilimumab data. She asked a question about the PV indication for Jakafi since Sanofi has apparently dropped their trial for a competing drug after a futility analysis. Rich Levy said Incyte is on track for filing in 2014 for approval of Jakafi in PV in late 2014. The third question involved expenses or how to better model expenses in R&D for 2014.
Sentiment: Strong Buy
Thanks. I am not at my best (whatever that is) before 10 AM.
I have to say that ever since the best science writer in the business (Gina Kolata) destroyed her career (she has since built a new one) going gaga over a magic bullet for cancer (angiogenesis inhibitors), I have been extra-skeptical of "breakthrough" ideas. Suddenly hopefully-synergistic drug combinations are checkpoint inhibitors. To be sure, there were a few successes under the old name, but a LOT lot of great ideas that never made it to registration (REALLY too bad, because there are great stories behind some of the failures--ask a medicinal chemist of a certain age about panaceamycin)