Pretty much for sure, going into ACR Lilly had an application already written for approval of baricitinib as a backup behind the TNF inhibitors. Then RA-BEAM came in much better than expected. The most likely reason they were late in filing an NDA was that they took time re-writing the paperwork for use at least on a par with the anti-TNFs (I speculated at the time that they might also be considering adding an extra trial to justify moving baricitinib ahead of anti-TNFs). Anyway, they should eventually have a higher patient count than any anti-TNF, probably equal to any two combined. The pricing is going to be tricky, because Lilly may want to go after a very large potential market in prevention of diabetic nephropathy. The potential patients there are pretty healthy, so they are also pretty price sensitive...but we're talking millions of them.
Xeljanz is a major obstacle. Not because it's any competition as a drug, but because it's a pretty bad drug that has come to represent "JAK inhibitor" to a lot of rheumatologists.
Anyway, I think Lilly revenues from baricitinib will pass $4bln annually by 2021.
Morgan the Fay (Probably an aspect of The Morrigan)(the nautical phenomenon is certainly seen as connected with The Banshee, which is an aspect of The Morrigan) is female. The associated folklore is fascinating. Her part in the Arthur cycle is the least of it. Interesting question whether Morgan and Undine are related. I think they're meant to be. In South European folklore, after Marko Kralevic realizes that he has been lucky and killed a hero greater than himself (biorhythms, no less), he must exile himself from the world.
Hate to concede that he has even a shade of a point. NYTimes did a story about drugs in needless shortage. Poster child is aminocaproic acid, the drug version of a major industrial chemical. API costs nothing at all and everyone knows it. So the price is low and only one company prepares it as a drug. They've had unspecified manufacturing problems which have lasted long enough to cause a severe shortage. Why hasn't anyone else stepped up? Well obviously, FDA is sensitized by problems at the incumbent supplier; even for an established generic drug, they have to approve manufacturing. There's also what I call the peaches effect. (Old old joke: a)Why are your peaches $1.89 a pound when Joe across the street sells them for $1.49? b)That's the price. If you don't like it, buy them from Joe a)But Joe is out of peaches b) If I was out of peaches, I could sell them for $1.49 too.) Anyway, the incumbent manufacturer holds the list price and a potential interloper is going to face enormous buyer resistance. Methotrexate is in short supply for a related reason: being able to offer MTX in your product line is part of being taken seriously as a generic supplier. But everyone offers it, and the established price is too low to induce them to offer open-ended amounts of it. So there's an enduring MTX shortage.
Point is, that while expensive drugs are too expensive in the US, The Twerp is correct that some cheap drugs are too cheap. And under normal market conditions, the mis-pricing can last for a long time and cause a lot of harm. I don't like his solution (re-create monopolies and make the cheap drugs ridiculously expensive), but this IS a problem and deserves some attention.
Company hitting on all cylinders. Maybe some uncertainty about timing of earnings through the year, but the bigger numbers are pushed earlier. Uncertainty about back reimbursement for Prolaris (it's not legally mandated, but it's RIGHT, at least for the gap between the legally mandated time for a reimbursement decision and when it actually came), but company flatly denies that the make-up is included in forecasts. Selling Vectra (rather than just making it available) WORKS. So of course the stock drops 8% at the open. What could be more natural.
If I was buying calls, I'd go for the Jan 2018s. Roughly the expected price difference for twice the duration, but Dec expiration is barely within the time window for bari approval, and if approval comes late there might be pressure on INCY. In contrast, Lilly will have reported on probably the 3rd quarter of bari sales at the later expiration. If Janus 1 comes in positive, but below full significance (a moderately likely scenario), the extra year gives Janus 2 time to come in. Same general sort of issue for epac: we'll probably see more positive exploratory phase 2s, but I doubt that there'll be real comfort with its path to income generation before Dec expiration.
I don't see much point in selling puts at all. The prices don't reflect fear of further price declines, or even concern about valuation.
Net: if I wanted more exposure I'd just buy the stock, and perhaps sell Dec calls.
If you were an analyst, and management had just given its expected presentation, what questions would you ask them? I hope most people will try to stay in the range of plausible ANALYST questions. Do allow that anything very med-techy will be put off to the presentation at AACR.
Right now I have 2, neither one of which is ordinarily within range, but may have been brought within range by circumstances.
1) Which phase 2s sponsored by Incyte have already passed their futility checkpoint without action being taken? For which of the trials referred to earlier in the CC has that checkpoint not been reached?
2) are there non-market forces affecting timing of expected milestones related to Jakavi?
Not me. I don't believe I HAD energy stocks. Whoever did was correct--he jumped from the fire to the frying pan. I DID sell some airline stocks to buy more Incyte. Given how the airlines have been slammed, that was a decent move too. What I didn't do, and it would have worked out badly if I had, was relax my personal standards for leverage.
I seriously doubt that anyone is going to ask a question about either the energy business or some nominally anonymous poster on Yahoo.
I doubt that an analyst would probe the availability of Incyte to M&A. The minimum price was apparently above $200 a share back when Jakafi was new in the market, and it certainly hasn't come down since then. Since this will be the full-year presentation, Julian Baker ought to be present, although not near a microphone. Like my proposed questions, present circumstances might push an analyst to ask him to say something. I doubt that there's anything he'd say beyond vague confidence in management.
And now: "Hard to accept that these imbeciles represent the people in our government," said Shkreli, using his @MartinShkreli Twitter handle.
What about a question about the obstacles to bringing the Jakafi / interferon combination into US practice? There was a spectacularly favorable poster on it at ASH, and I believe Novartis is supporting trials in Europe. There are regulatory / marketing issues in the US that I don't understand. I actually hope that management brings this up. On a closely related note, I wouldn't mind either a management statement or a question about the possibility of reducing the price of the 5 mg Jakafi pill (already done with Jakavi), to capture some extra opportunities.
That is not information given on clinicaltrials. In fact, the futility / slaughter checkpoint is rarely mentioned at all unless it causes trial discontinuation. It's kind of implicit that in any "big enough" clinical trial that lasts "long enough" there will be a check some time around half-way between study initiation and final data collection. Some of the ongoing phase 2s are in an intermediate duration range. It was not mentioned in the press release on the high-CRP cohort of the trial against CRC that the low-CRP cohort would have a separate evaluation; that information was pried out by analysts. I was surprised that a trial described as enrolling patients regardless of CRP level would manage the cohorts so independently.
The only result I can see having real importance is the revenue from Jakafi sales. Dealing through specialty pharmacies obscures the story, but large/medium/small should show through. Large is over 65% YoY increase, medium is 55-65% and small is below 55%. Management pretends not to have a handle on breakout between MF and PV, but a large increase can only come from accelerating PV adoption. A small increase would leave open the possibility of the market beginning to saturate.
_Pace_ the reaction to the CRC news, nothing phase 2 means much (unless some partner is over-powering one in hope of approval of a combination without a phase 3). I DO hope we'll get some verbiage on mid-trial evaluations, and a one-time snapshot of what has and hasn't gone through such would be a nice touch (If management doesn't volunteer the snapshot, they probably won't answer if asked for it). Simply a list of phase 2s expected to complete this coming Q would be welcome (even having to search clinicaltrials is an annoyance, and dates that slip aren't necessarily changed right away)
If Merck hasn't said anything about the collaborative phase 3 Incyte won't either. We may hear about participation in further Lilly phase 3s. I'm not aware of any possible Incyte-only phase 3 information that might be announced.
I can't get away from the Nov SITC fiasco. And we saw a lesser version of the same problem just now. Incyte has depended too much on convertible financing in the past to offend that class of investors now, and above all things they demand orderly markets. Some kind of announcement that promises follow-up when news has left confusion in its wake would be extremely welcome.
Of course, we'll get a clinical info dump in 2 months, so not much novel this week.
This is the year of cash. There may be some reaction to Jakafi sales, but I don't expect a result very far from what's generally anticipated. Janus 1 is the #$%$ in the room and too close to speculate about. I've already explained at great length why I give it a 75% chance of success. I'd give it another 10% or so chance of a favorable but not statistically significant result, which on the one hand would let Janus 2 have a shot at putting PaCa on-label, but on the other hand would incur the considerable expense of finishing Janus 2 with no guarantee of a payoff. (The estimates of the money at stake there that I have seen are laughably low--the key to selling is not how much it lengthens life [most likely benefit a shade under a month] but how much better patients taking it look and feel) If it is announced that some phase 2s of ruxo combinations addressing high-prevalence cancers are continuing post mid-trial evaluation, it could have some benefit (comparable to the harm from CRC). We won't soon get an explicit story about how epac will make money. Lilly is unlikely to talk about bari pricing before approval.
The word that got censored, by the way, was a word for a bizarre supernatural creature that is a rather obsolete racial insult. Reminds me of when the first name of the chairman of Lehman at the time of its collapse got censored (in retrospect, THAT one almost makes sense). Hmm, if I talk about dancing a jig (word could be followed by -saw puzzle, in case you don't see it) will that get censored?
You can comment on Motley fool articles again, but it sure looks like you have to link to a Facebook account. My contact information isn't exactly something that would need to be redacted from Hillary's emails, but making it THAT public in front of what can be presumed to be a swarm of Geroniacs seems like a bad deal.
Yahoo is being VERY difficult. This is my FIFTH try.
Important countries listing ruxo in pharmacopeias: Denmark, Spain. Important ones I can't confirm: Italy, Netherlands. France approves on a national level, but has regional "home rule"
N.I.C.E. revisions are routine. UK should allow Jakavi for MF after the long-term follow-up data previewed at ASH 2015 get journal publication.
The list of countries where Jakavi is approved is not, of course, Incyte's to comment on.
Take a look at some big and super-big oil companies. Their declines are, after all, where most of the money vanished from the market. Two comments: first, they seem to have declined less than Incyte Second, they seem to be stabilizing.
For the first point, I recall that "When elephants battle, the grass suffers" The second point encourages my constitutional optimism.
Yeah, there are smaller oil/gas companies doing a lot worse. I just don't think they're as much of a force pushing the broader market.
I'm afraid that all today's close indicates is that by afternoon, the trading monkeys had gotten the word that a serious potential competitor had blown up. Since we don't know much detail about the problem (except that it seems to let people die), it remains a possibility that the right balance of JAK-1 / 2 activity is part of the benefit of ruxo. That would make life a lot harder for other newcomers.
I consider that "no recession is at hand" a pretty close one. The engine of severe recessions is low demand. There are a lot of ways that can happen. In the present environment, income inequality has left the lower 2/3 of the US economic heap pretty constrained In what they can buy, while the oil price collapse and its consequences have left a lot of the people who have enough money to buy stuff feeling threatened. This has a possibility of going bad.
I'm comparing this to 1998, when the Russian collapse passed with modest harm to the US, but we had a stronger middle class back then.
The game is now about cash. Especially about recurring cash
(as opposed to milestones). For now, that means Jakafi sales vs MPNs. Sales vs PaCa could start around the next CC (while salespeople are unlikely to call anyone's attention to a good result in Janus 1, oncologists will inform themselves--guaranteed). It isn't so clear that there's another new source of income before next Winter.
It won't hurt when Merck actually begins the epac-combo phase 3. I hope someone else announces an intention to do a phase 3 with an epac combo vs a big 3 cancer before this Q ends.
It's a complication that information flow from Incyte has been weak when it could have stabilized the market Convertible holders demand orderly markets. but everyone prefers them. Incyte did nothing to dispute the rumor about ruxo patent expiration, which might have been harmless except that the Geron publicity mob got a bunch of press while that rumor was live. Incyte allowed itself to look dishonest by not clarifying its connection to the Keytruda / epac abstract, and then exponentiated the problem by allowing rumors about the full presentation to go unchecked. Just lately, we've had a minimal release on the phase 2 combo against CRC, when there's no obvious reason it could not have been clarified a little, or even put in context.
The list of kinds of AEs suggests an off-target activity. The molecular structure of pacritinib is consistent with crown-ether-like ion binding, which is, in turn, consistent with these AEs. If this is what's happening, bleeding problems may be overcome, but heart function problems look likely to be intractable.