A tip: Yahoo eats extra spaces. If you want to align columns, do it with symbols (periods are usually best).
That marks 2 1/2 months of declining short interest. In widow-dressing season, MYGN [with a nice gain for the year] isn't under pressure. With NO short squeeze, January new money is likely to take it to ~$50. Somewhat-orderly closing of the short position ought to be worth another $5. If the short managers get fired and their replacements are told to clean up the mess NOW, the peak could go as high as $65 (I'd sell most of my position if I could get $60 before Summer [actually, a decent fraction of my position is short puts expiring before Summer])
Another day, another batch of abstracts. #824..Demo series, kinda like what that Minnesnowta guy did with the S,N oligonucleotide. IFN alpha-2 + ruxo. Miraculous results [but low n, possible subgroup issues] still...; 700...ruxo and also a PI3Kdelta inhibitor identified as likely agents against NK cell cancers--rare, but at least one is very concentrated in an identifiable population [=easy to sell]; 1606...Ruxo doesn't increase risk of severe infections [?!?!]. Treatment with steroids before ruxo does; #4370 is a little "inside baseball"--the most important reason Jakafi may need to be discontinued suddenly is to increase the success rate of stem cell transplantation. This massively underpowered study at least doesn't suggest that the sudden stop is necessary; #4077 is kinda personal vindication--I've been saying that the apparent rapid sell-in of Jakafi against PV reflects great dissatisfaction with supposedly-effective treatment. This study measured it.
Lots of investigator-sponsored preclinical and early-clinical studies of checkpoint combinations.
Time to start cooking.
Too many of them for one sit-down. Got about 1/3 through. Some notable ones: #858...Ruxo may be useful in treating graft-vs-host disease [potentially HUGE]; #2799...registry study confirming COMFORT extensions; #2817...exploring ruxo use in those starting with low platelets [can be done with care]; #1604...anemias developing in response to ruxo treatment have little prognostic significance; #2104...Ruxo is not significantly less effective than transplant in extending MF survival [wow!]; #4065...an unexpected way ruxo extends MPN survival; #2048...Ruxo is worth trying for sickle cell and thalassemia [potentially big in the future; these are common but rarely treated with big-$$ drugs].
Lots of combination trials including ruxo, some interesting.
This appears to be from Palmetto, in other words, CMS (Really--even when Yahoo won't let you post urls, SOME clue to sources is a real help).
Anyway, this has little effect on commercial reimbursement, which is substantially backed up behind an extra clinical trial. From the SA transcript of the most recent quarterly call: "we have reinitiated dialogue with private payers to discuss the clinical utility of Vectra DA in managing their RA patients. Additionally, we are completing the plans for our prospective clinical utility study and plan to initiate enrollment in early calendar year 2016."
I think that's a separate process. The way I reconstruct it, AMA assigns CPT codes which are supposed to be a way of saying exactly what was done, and then CMS decides what to pay for each one. I could have this totally screwed up.
There was just a "Palliative care in oncology" symposium with a session on anorexia and cachexia. In other words, they discussed the problem that lots of cancer patients lose weight, some while not eating and some despite eating. There are a few relatively ineffective treatments. The problem is extremely distressing to family, but apparently less so to the patients themselves.
Anyway, this is a good time for awareness, because ruxo produced weight gain in terminal pancreatic cancer patients in the Recap study. Janus 1, remember, reports in April.
These are al trials of drug combinations with unrelated modes of action, seeking additive effects. Old style combinations even though the drugs are new.
This is the sort of thing grownup drug companies do; Incyte, effectively a teenager, has to swing more for the fences of synergistic combinations.
Reimbursement for Vectra DA revised upward (I Don't know if it's as high as Myriad requested). Legacy BRACAnalysis confirmed 10% reduction.
I suspect that Myriad will take the hint and include Vectra in their move toward kit-based tests. Since it's protein-based, that part of the move is still in early stages.
We ought to see whether Medicare gives retroactive Prolaris reimbursement willingly before the next CC. (I think they'll offer 4 months because they'd probably lose a legal confrontation over delays beyond the statutory deadline)(I think Myriad will puff and posture over the additional 6 months they are probably entitled to, but I don't think they'll go to court in the end).
Got it. Myriad is certainly going to be trying to expand that LCD. I myself think stage T2a or better is unreasonably [implausibly?] restrictive; Myriad can be expected to push for T3c (spread through prostate and into seminal vesicles--that is, local invasion with no clears sign of a tendency to spread remotely); I think nearly everyone expected a T2b cutoff. Myriad is going to hate cutoffs on PSA at diagnosis and on Gleason score. Basically, CMS is cutting reimbursement to leave out the cases where Prolaris can make the biggest difference in treatment decisions. But hey, it's SOME coverage.
Me replying to V?!?! Well, I'll pretend Good TJ posted this.
Myeloma is the equivalent lymphoid condition to the myeloid condition MF. It has some odd features, so early attempts at targeted therapies backfired. This is the first success in the latest round of targeted therapies. This, like a lot of the others, is a biologic, with the usual downsides. The incumbent drugs aren't any of them wonderful, so this is a nice addition.
JAK inhibition hasn't succeeded against myeloma, although there's some hope for JAK-1 selective agents. Incyte's main effort against myeloma is the PIM inhibitor program. That program is too new for me to know much, but it seems to be about oral small molecule drugs, more attractive in principle than biologics. So this approval doesn't affect current Incyte business and doesn't either block a future target or offer obvious hopes for a synergies. On that basis, neutral.
For board dwellers, it'll be interesting to see whether this soaks up J&J's blood cancers budget (starving out that P,N oligonucleotide) or whets their appetite in blood cancers (boosting it). I've already predicted that That Candidate will be targeted exclusively against the MPNs fairly soon anyway, so we may be left with only our home grown pests.
This isn't such a dramatic move, and I don't think you should look for a fundamental reason for moves under a year long. There was an accusation made of misleading (not improper, because the division of recurring from episodic was an in-house distinction) accounting. I don't think it was really answered. The buddy show on the CC didn't make lots of friends (It was better than the "We have nothing to say" of the last days of the prior regime). Having no forecasts at all (something that was supposed to change) for major parts of the business doesn't make friends either.
I can recall TSRA in the $10-12 range. The current range reflects SOME belief in management, but return to old highs will require a year or more of something that looks like steady-state operation. Meanwhile, dividends are nice, and may even constitute a more honest forecast than anything spoken.
We're now in window dressing season, which ought to be good for INCY this year. After that comes January Effect (new money) season, and I expect that to be good for INCY too. The Lilly NDA filing may have some effect (hard to predict whether portfolio runners will connect it to INCY). Next unschedulable event likely to be combination results on Opdivo+epac. Since the cube rats have dismissed epac, that's more a risk than an opportunity. Next Q release ought to be received well because there ought to be enough milestones to turn the bottom line black. Serious risk [opportunity?], though: YoY Jakafi earnings comparison can hardly return to +69%, and isn't likely to match +65%; a decline there could become a hook for unfavorable reports [continued drastic growth could change estimates of ultimate market size].
After Feb, we're likely to be in a "Show me the money" environment. Janus-1 will report; it's likely to succeed, but I'd put the probability of that closer to 70% than to 90%. Showy success would mean immediate money while complete failure would at least take Janus-2 and its costs out of the picture. Trying to push my crystal ball farther causes overheating. One thing that doesn't matter much to us financially, but may affect the climate on the board: I expect that S,N oligonucleotide to be entirely redirected to MDSs around April (too many grade 3 AEs to push on against a target with other treatments available)
No. Recurring revenues are supposed to be license fees, consulting fees and royalties. Settlements of lawsuits are supposed to be episodic. The concept is that if you have very clever people specializing in particular parts of an overwhelmingly large problem (the semiconductor business), the present value of the money you can make collaborating, with little reference to possible lawsuits will be more valuable to stockholders than the sum of the lesser recurring amounts you could get if potential customers came to you only as a last resort, and you had to get large amounts from bad customers (after long delays) with lawsuits. What we've seen in the past couple of years is that shareholders are delighted with the proceeds from settling old seemingly-endless lawsuits on generous terms. And I guess the bearish idea is that some of the companies settled with may have entered into cooperative development agreements just to help settle the cases, and won't extend those agreements.
This is no longer one of my principal holdings (I'm a lot more into biomed now), but I still listen to the CCs. If it's important to you, listen to the CCs and brows the technology descriptions on the web site.
Yeah, it's a big deal. More a difficult customer than a competitor, since Tessera doesn't manufacture directly. Their earlier disputes were carefully staged to avoid knife-to-throat court battles. In an earlier dispute with others, Tessera got an object lesson in the difficulty of collecting royalties on products manufactured by overseas third parties. We can expect plenty of ongoing activity, but neither side wants headlines.
I think recent price weakness has more to do with investors noting that the change from a combative, legal-windfall-oriented style to the new cuddly Tessera is pretty much complete, and asking if the present model really works. (and I have to wonder whether the shift from a closed, hostile style of management presentation to the "buddy show" of the last CC is creating doubts about management...seriousness)
Episodic/recurring is essentially a Tessera mgmt. division, meant to make their graphs prettier (and perhaps more realistic). My star example of "bad accounting" intended to make the numbers more realistic, but often abused, is "Economic Value Added," much touted by minions of Hell^H^H^H^H McKinsey (essentially, depreciating capital items forever rather until they reach zero). I think the point is that to understand how a company is doing, you need to look at both GAAP numbers and also reasons to prefer a different presentation. The underlying reason for recurring / episodic is to discourage division heads from getting into high-stakes confrontations with [potential] customers. The practice kind of goes back on that.
Because you're such good people?
Between now and the next CC:
Reconsideration of Vectra reimbursement [a lot of oxen were gored, so relief likely]
Introduction of myChoice HRD
Decision on retroactive Prolaris reimbursement (Jun-Oct better than 70% likely; Jan-Oct well, maybe)
Launch (with Thermo-Fisher) of some tests in kit form
After further review:
Lilly is definitely going to try for a label that encourages use of bari before either MTX or anti-TNFs. They seem resigned to a difficult sell-in (Comment somewhere about no matter what's on offer, MTX will get tried before anything new). Single agent, bari beats the pants off either of those, but MTX+Humira is comparably effective with bari alone, and safer than MTX+bari ( don't know what fraction of anti-TNFs are given in combination with MTX). So I'll guess that they brag their heads off about single-agent results and include combination of bari with MTX as-is in their filing, and start some small p2s to justify a later label addition kind of like the dose titration that went on the Jakafi label after 2 years. I'm guessing that they already have some very specific ideas, because if they didn't, they'd have been more open about AEs that fell in the medium annoyance range. With very plausible timing, they could have the solution presented at meetings around the time bari gets licensed (say Jan / Feb 2017). It's not the sort of thing that Must be on the label as long as it's widely known.
Pricing gets affected in here. If they want bari used before MTX, it can't be as expensive as, say, Jakafi. And if the diabetic nephropathy results look good, they'll again want the drug relatively affordable (this is a very delicate marketing exercise; when you're looking at a market of maybe 20MM relatively healthy US patients at low risk of catastrophe, a small pricing error can get you hanged)(DN progresses fast enough when it happens so you want to treat a lot of 'at risk' if feasible). Fortunately, that stuff won't have to be decided until the drug is about to hit the shelves.
Oh, darn. Looked up Janus 1 on clinicaltrials. Completion moved from February to April. So we won't be hearing about topline in the next CC.