Nice deke by management. They had us looking at ASCO. Then again, pretty much nobody expected much so soon from the combo trials.
What do You think it means that they're expanding the trial of '110 for second-line against PaCa while dropping plans for first-line? Tea leaves not clear, but someplace in there is the possibility that Ruxo is doing well enough (when tolerated) to bump back '110.
I hadn't heard of a bromodomain 4 months ago, and now I are a investor in one.
Guess at why they call the Monday talk 'investor' rather than 'scientific' looking good.
Reuters has circulated an expanded version (dated 4/14) of the story that set me off a couple days ago. One guess how many people they found on the "poor people should just die" side of the issue. It lists a couple managed care programs that do panels when appropriate, some that don't and the nasty insurers.
The article also touches on the VUS problem.
Also, it says that Myriad has 90% of the hereditary cancer testing market, which suggests that competition has not been ruinous.
A plausible guess is that the clinical research program is accelerating, and they want a central location for interactions with European project leaders. This would go along with my wild guess yesterday that we're about to be hearing more about the clinical trials roadmap. The preference in Europe for specialized institutes to treat diseases with sufficiently similar features makes it easier to recruit for medium-sized trials Over There. The announced 9000 sq ft is roughly appropriate to accommodate that function and a moderate amount of business activity (say, coordinating product reimbursement activities). It's too small to be a poison pill against Novartis (a laughable idea anyway) and too big to be a simple pied a terre for merger negotiations.
Try it again. Refusing to pay for myRisk [and similar] because it may get people to seek excessive medical treatment is only 95% evil. The 5% non-evil should be addressed by making it as easy as possible to turn findings into strongly justified courses of action. Almost for sure, testing company sales training programs are the best presently-available education on the practical significance of the test results. People in public health and counseling professions ought to be offered the same training that testing company sales staff get.
But the insurance companies ARE being 95% evil.
The AACR [Philadelphia] presentation is described on the Incyte web site as an "Investor event presentation." Sounds odd for the venue. Sounds odd for so close to the CC, too. The most plausible 'investor' rather than 'scientific' theme I can think of would be an overview of the collaborative study program, just in terms of what is being tried, possibly with an update on when the first visible results might be expected.
Enough already. The kakophony (unusual spelling mean to prod you to consider the etymology) from Incyte haters has all been refuted before. The only new features are the possibility that FDA may allow drugs to be targeted and tested against disease features, which may allow Imetelstat to find a market, and scientific progress regarding fundamental mechanisms of "mainstream" MPNs which may put a closing date on the whole issue. After MF and PV fade into history, Ruxo may well live on against cancer inflammation (With new method-of-use patents, natch).
Historically, enough of the vandals have been paid bashers (who get paid by the disruption they cause) so I'm through responding to them for the quarter.
As puzzled as anyone. I've said before: I expect ASCO to be neutral to negative. Inventory games will make this Q's Jakafi sales look good. There are some big milestones in the air. Futility / slaughter read on Janus 1 is due--slaughter would easily be worth $40, but even no news could be worth this much. Another thing about the right size would be expansion of one of the pipeline combination p2s.
For that matter, again as I've said before, as a company that is just turning profitable but with huge prospects at the far end of an investor's time horizon, Incyte is about as interest-sensitive as it gets, and rate hikes look like being a little late this year.
A bit more on interest rates: scuttlebutt is that the Fed's first move of an increase will be paying more for bank reserves in its hands. Of all moves they could make to raise short-term rates, that has the least effect on rates investors look at.
Reuters has a story today about insurance companies refusing to pay for multi-gene panel cancer risk testing. My first reaction, of course, is that I know a good oncologist who could manage their investment portfolios.
But step back and maybe they aren't totally execrable (that's as nice a thing as I'll ever say about a health insurance company). There's a big jump between Angelina Jolie, with high risk mutations to both BRCA 1 and BRCA 2, and family members dead of associated cancers, and someone who turns up one risky mutation on a less-threatening gene, and who has no known family members with cancers that suggest involvement of that gene.
A human being does not draw the conclusion that the tests should not be given, but does start thinking about ways to get the best use from them. Clearly, dropping a report "You have a risky mutation" in the mail to some ignorant slob (say an insurance executive) is the route to either panic or dismissal. But equally clearly, telling someone "You have N times the population baseline risk for [mumble] cancer, and the fading-away of annual physicals shouldn't apply to you" is a benefit.
I think of the testing for tuberculosis that was done in elementary schools years ago. In practice, as the risk level dropped, the test sensitivity was increased to give a rate of detection that scarce resources (more public health professionals than medical ones) could deal with. The non-medical resources for dealing with cancer-risk-enhancing mutations are now exceedingly thin.
Today, the best training on appropriate responses to findings from multi-gene panels is probably being given to detailers from the companies offering those panels. Obviously, having salespeople practice medicine is comparable to having insurance executives do it, but opening up in-house training programs to public health people in return for a move toward insurance sanity looks like a way forward.
A double dose of Imetelstat, given once, is a life-threatening event. That is a level of toxicity that greatly favors alternatives. Tefferi, for all his flaws, is one of the best physicians in the world at treating hematologic cancers (a fact that paradoxically lowers the impact of the good results he achieved with IM: he gets good results with hydroxyurea, which nobody considers a desirable drug). There is compelling evidence that Jakafi prolongs survival of MF patients. There isn't real evidence of anything for Imetelstat.
There are apparently research results suggesting that the entire signaling pathway that is defective in the "mainstream" MPNs can be repaired by targeted gene modification. So this whole dispute may end rather suddenly in 5 years or so.
The drug is simply too toxic for a market with multiple competitors. When you strip the available results down to improvement / no change / worsening and ignore overheated prose, it has shown middle-of-the-road results. And most of the available results are from Tefferi's clinical use program, which didn't have either a protocol or a control group. News stories have FDA considering ways to vet drugs targeted at disease features, but they haven't announced yet. "Other MPNs," each of which is too rare for ordinary orphan drug development, but which together make up a worthwhile target with enough common features to qualify, look like a natural target.
'The art is long, life is short, opportunity fleeting, experiment dangerous, judgment difficult.' Hippocrates
Jakafi may be temporary, but for MF, Imetelstat is never. It has a decent chance to become drug of choice to treat "other" MPNs.
This one is too precious to waste. On the topic of otherwise bright men taking their balls and going home when the world doesn't live up to their predictions, I give you an extract from "Cashin's Comments" of April 7.
"Caution Is In The Air –
In today's Bloomberg Brief, there's an interview of Stephen Roach who states that the U.S. is in a bubble (Fed induced).
In a separate interview, republished in MarketWatch, my friend Mohamed El-Erian states that he has virtually all of his assets in cash.
He was then asked if we are in or near a bubble. Here's a bit of what he said:
Go back to central banks. Central banks look at growth, at employment, at wages. They are too low. They don’t have the instruments they need, but they feel obliged to do something. So they artificially lift asset prices by maintaining zero interest rates and by using their balance sheet to buy assets.
“Why? Because they hope that they will trigger what’s called the wealth effect. That you will open your 401(k), see it has gone up in price, and you’ll spend. And that companies will see their shares are going up and they will be more willing to invest. But there is a massive gap right now between asset prices and fundamentals
Two very smart men talking about consequences of Fed induced bubbles. Kind of makes you wary."
That "growth investment bubble" is a popular bogeyman (Yeah, I'm almost for sure the Left fringe of politics here). It isn't bubbly when present pricing reflects present [interest rate] conditions. The world says "Try to find increasing earnings streams, and good bonds are as hopeless as buried cash;" El-Erian buries his cash.
If we're looking at the same note, the imminent pickings are sorta thin. The first 3 Bari p3s in RA MUST show positive for the drug to have a future, but that's a pretty low hurdle. Licensing and market size depend on structural preservation, which is only addressed in the final p3, due end of Fall. The nephropathy p2 may be interesting, but that's an indication that gets everything thrown at it and little has stuck so far. It'd take a lot to wake people up (like a clinically meaningful difference significant at the 5% level from this under-powered trial). All the exploratory p2s out there are interesting to the fan base, but are unlikely to move pricing much. (What has Recap already done? You could argue that post hoc ergo propter hoc the stock has moved up, but the commentaries focus more on the PV opportunity and the IDO inhibitor. Stock price would probably be higher if Recap's 'magic subset' had been defined by either incoming QoL measures or some novel test.) They don't mention the mid-trial judgment on Janus 1, which we've just entered a roughly 2-month window for. Such things aren't always announced.
That's about the least surprising press release I've seen all year, but I'd be happy with your price target (although mine is a few points higher).
BoA/ML just mentioned Myriad in a research note (no b/s/h attached to the note, but the price projection is for little change). Aside from the usual stuff, which figures to be answered by Summer, their concern is whether pricing will hold. That would mostly affect myRisk on an investor's time scale. I hope it doesn't come to a battle, but if base reimbursement is too low it isn't an impossible selling exercise to get patients/providers to go for a couple hundred extra dollars of copay to get "the most reliable." Backing a claim of superiority is an exercise for the clinical department. I view Vectra pricing as having smoothing feedback--if it's less expensive it will be ordered more often. And I just don't see what could go wrong with Prolaris from here (what asteroid?)
I kinda sorta agree on interest rates--not two years near zero, but probably one. 'Suddenly' is a key word because I expect some revival in residential construction, and that is subject to 'suddenlies.' The problem is that so many people with fingers in major money hoards are committed to rate increases SOON, and they head for cash when the world doesn't behave the way they think it should--even when the way the world is behaving indicates that growth companies are the place for money.
I'm not concerned about ol' 387 REALLT taking market from Ruxo, but this is the first time it's reasonably likely to get talked about in a while. And Gilead DOES have fans.
I think that the predominant negative in the market lately has been jobs weakness. This is fundamentally positive for Incyte because valuation is interest-rate-sensitive and jobs weakness postpones rate hikes. However, a lot of investing bigshots have been public about wanting and needing interest rate increases soon. They hate being shown up and tend to reduce holdings when it's obvious that they don't understand what's going on. (The interest rate story is complicated and reinforced by Euro weakness--a 70 cent Euro doesn't look entirely impossible, and that would make Europe look like China did ten years ago) Incyte may be suffering some specific shadowing as Gilead fans talk about the wonders they expect from CYT387 (Momolitinib) (of which we may hear a bit as ASH).
Still 3 weeks before even the abstract titles from ASCO. Janus 1 futility / slaughter evaluation in April-June window (no news is good-ish news). CC early May (first Thurs the last 2 years). Mostly, we're driving without a road until something grabs interest.
Interesting point: she had the mastectomy in accordance with best medical advice. (There doesn't seem to be a way to say for sure whether it was needed, but given her obvious concern, the fact that operating early gave a good cosmetic and functional outcome is a big plus) She had the present surgery going beyond best medical advice, and the pathology report confirmed that it was premature, if not entirely unneeded.