I would guess 80 MM of "Jakafi" sales (I expect Jakafi sales for MF to hit $125MM around Q3 of '15) and 13-15MM of royalties. SG&A is hard to call; I'll give you the 40MM, but can't see why you'd call that "exploding." Contract income is also hard to call, but with Incyte conducting the trials on the immune-oncology cooperations it isn't going to go away. Your R&D number might be low--so many of the clinical trials are set up as investigator-sponsored that it's hard to judge. But Janus 2 is going to be an expensive trial eventually, even if it isn't starting fast. So yeah, a GAAP loss.
Looked at a chart out of curiosity. Please give dates and prices of 3 lower highs and 3 lower lows (implicit: a 1-day chart doesn't count unless you predict 40s within a week). In your own time.
Nice Seeking Alpha article by Richard Pearson, a bear, about a couple boiler rooms that specialize in bulling biotech stocks with low institutional ownership. Not that it applies directly, but it's a look at remarkably sophisticated techniques for manipulating sentiment. Let's see if the link can be posted http://seekingalpha.com/article/2301825-behind-the-promotion-of-northwest-bio
Ok, it's a bet. MYGN goes to $50 for at least 2 hours any time within a month after the CMS decision, I'll post that I was wrong. Doesn't pass $45 within the month, you post that you were wrong. Middle ground is close enough to a tie for gummint work. On?
I think we're in a severe "Show me the money!" situation. So I'd expect an advance on a reimbursement announcement to be small and short-lived. It'll take actual sales data, and maybe even earnings data, to generate a big move.
You know that my other big drug developer holding is Intermune. They filed an 8K today saying that FDA had agreed that their NDA had been filed and giving them a late November PDUFA date. Apparently you haven't filed until FDA says you've filed [basically, that they agree there's enough information for them to base a decision on it]. So it's entirely possible that Incyte has already done what most of us would call filing the sNDA, but the company doesn't want to anticipate FDA by saying so.
My classification of time frames may seem a little stretched. Let's say either visible movement or new debt by October. Probably sorted out before FDA approval. The cash position right now isn't enormously favorable for a US drug introduction, so there figures to be a third shoe, and it would be more common to see new debt placed with the second round of conversions than otherwise if the company planned on staying independent.
Karnofsky score is a measure of the patient's present condition, not of prognosis. Not being remotely an oncologist, I don't know what predicts short life expectancy in PaCa, but I trust that there are such indicators (I'm told that intestinal bleeding is often the terminal event, so an index of intestinal tumor mass might be used). Inclusion/exclusion criteria often include items related to life expectancy (looking quickly, the old study vs myeloma NCT00639002 excluded for CNS involvement).
It's perfectly legitimate to tweak study inclusion to highlight your drug's effect, so long as you tweak all study arms the same way and tell afterward what tweaks you used.
This is all based on a comment in the JMP presentation that it appeared that responders and non-responders within the study group diverged during the study (and a hint that this was because the non-responders died early). I don't find a supporting graph in the PDF, and in any event the numbers are too small to have faith in. But it's a hint in a helpful direction.
I saw the same as you, but I've also seen [unrelated] clinicaltrials entries on completed studies where inclusion/exclusion criteria were only partly described. It appears that as long as you don't say anything false you're allowed to leave some things unsaid.
I've commented on HH's accent too, pretty similarly. The point isn't whether he's pleasant to listen to, but how his peculiarities as a speaker affect stock price (or don't). And that's just it: HH's speaking doesn't seem to affect the stock price, while Friedman's did, at least sometimes.
Short-term kicks to the stock price aren't as important now as they were before financing solidified, but a really bad one could scuttle a business combination negotiation.
Cynical fellow that I am (Доверяй, но проверяй), I wonder if the pattern we've seen of adding a nugget or two in every successive CC / analyst meeting may be one of Daly's contributions too. It COULD be an accident, but the information control before he came on board was pretty strict.
Mention of a positive for the JANUS studies.
What it comes down to is that there may have been a "too sick to help" subgroup present among the RECAP subjects, and that if they hadn't been included, the results would have looked more favorable.
The evidence for this is shaky, and the argument won't wash with clinicians, but I'm pretty sure it will be taken into account while enrolling for JANUS. Gooses the chance of success a little. (You have to get Bayesian to see this clearly--say that there's a 40% chance that the effect is real, and that if it's real it affects results by 20%. You're allowed to treat that as if they were successive events and improve the "expected" result by 8%, even though they aren't really successive events)
Only the futility / slaughter decision on JANUS is within a reasonable investment time horizon, so there's nothing to act on now.
Seems to me he was brought in to make sure the August 2012 CC fiasco wasn't repeated. To be sure, no longer having the over-cautious Dr Paul as the public voice makes his job easier (but convincing the founding chairman and guiding genius to abandon the spotlight can't have been easy). We seem to be getting our money's worth.
Medtronic "possibly" looking is ancient news; they did the clot-catcher deal already, after all. ABT just makes too much sense to be new. So I don't expect short-term impact unless somebody actually pulls the trigger,
Too much belief out there that EZ is a badly-run company. Eliminating the advisory fee was A step; Replacing the revolver was probably necessary, and won't be seen as either smart or otherwise. Any move more than a token one will require evidence of either management wisdom or friendliness to owners. It wouldn't be hard, but will it happen?
I'm afraid that the marketplace has spoken, and NICE is unlikely to repeat King Canute's mistake. I can't guess when, but they will approve Jakavi.. It's risky for them as individuals to delay until after FDA decides on whether references to life extension can go on the label--they look like jerks either way that decision comes out (if they DID command the tide to stop and if FDA doesn't allow the mentions, they might not look too bad, but all 3 other combinations look awful for them)
I'm still working up my + and - cases, but I don't see any unarguable positive catalysts in the next 9 months. On the other hand, about the only negative catalyst I can see is a turning away from immunooncology. The "Jakafi for MF and PV company" would be worth something like the present stock price. So leaving out M&A possibilities, I don't expect much excitement. The JANUS trials take a lot of the possible impact away from any investigator-sponsored trials.
A bit of a waving flag. That's a little over 1/3 of the convertible issue. Whether the company intends to merge or stay independent, clearing out the old debt is a useful step. So one way or another, we can expect to see more action. In the nature of things, you don't issue new debt after announcing a big R&D commitment, so this strengthens the case for a clear merge/continue decision by February. A new debt issue by then would telegraph an intention to stay independent. More negotiated redemption without new borrowing would suggest intention to merge.
I believe alopecia universalis is considered an autoimmune disease, so the JAK3 action of Tofa is probably involved here.
The easiest way to think of JAK 1/2 drugs in inflammation is as being mostly like TNF blockers (TNF signals through the JAKs). So since TNF blockers work against psoriasis, we can expect Bari to. Dose to control psoriasis runs high, but recall that Bari pretty much didn't have a dose-limiting toxicity in the RA p2 (it has low affinity for bone marrow, which is the organ where it might cause the most trouble). Historically, there's a licensing problem in psoriasis. FDA regards it as neither crippling nor life-threatening, so they are more demanding than they'd be for a drug treating a disease they regard as worse. That's how the TNF blockers came to be approved for RA first, then psoriatic arthritis, and only then psoriasis.