I'd like a simple explanation of how Crediamigo, with a business model that looked bulletproof on the surface, turned out to be a disaster. On the surface: employer tells employees that they can get unsecured loans below locally prevailing rates. Loans repaid by salary deduction. What went wrong?
So little traffic around here. Yeah, Eastman has too many moving parts to follow easily, but that means that something interesting us usually happening somewhere in the company.
Cellulose acetate was the origin of the Eastman chemicals business. Selling its half of the Primester JV to its partner Solvay sure seems like a statement that while it is still a good business, the future is elsewhere.
Somebody reading this must know more about the big uncertainties in that estimate. Biggest guess is capturing 2-3% (10% of a quarter) of RA patients presently on "conventional" treatments.
I DO have to admit that it was pleasing to have top-down and bottom-up numbers land within sight of each other.
Convenience of bari is unarguable, but I don't think the cost savings are going to be that large.
The rise of infused drugs is, in large part, the rise of protein drugs. When there is a well-defined target, i's very often possible to generate a protein that binds to it. It's often more-or-less straightforward to turn a binding protein into a drug candidate. Consider insulin, pretty much the first protein drug: after almost a hundred years, the exact properties can be modified lots of different ways, but routes other than injection are still problematic.
Your story on Remicade pricing is interesting. I hadn't realized that price depended on dose.
Do ask at your main annual doctor visit whether any of the latest progress against Crohn's disease might help you. Big success story.
Ok, let's do this together. Say the biologics go for around $80K a year. I make that about a quarter million customers. I know some people using them, and they seriously need such powerful treatments. Let's say something like 10 times that many are using MTX or other, lesser, powerful DMARDs (these people aren't so sick that ALL their friends know what's going on, so I'm only aware of one, who is very happy with the treatment). I'm going to guess, though, that the population treated with non-TNF-directed DMARDs is like the population with conventionally-treated PV: something like a quarter aren't as happy with the outcome as their charts suggest. Keeping numbers round, that's about 800K addressable population, Leaves us with the interesting possibility that early adoption may be dominated by the non-anti-TNF patients who resisted going to injectables or shunned the risks of anti-TNFs, seeking stronger treatments. Sick RA patients tend to get looked at seriously more than twice a year (the best current test for RA disease activity is reimbursed up to twice a year by Mediacare, and there's some push for more). My friend who has the worst RA has gotten about 4 years from each treatment scheme before needing a change. Point is that rate of treatment reviews shouldn't really affect the adoption curve.
So, temporarily dismissing other anti-JAKs along with other innovations, at peak you could have about 50K patients from the non-TNF pool and 70K from the present TNF pool. Let's pick a $60K price from where the Sun don't shine. Gives a peak market of $7.2bln.
I have almost no confidence in any of this, so please pitch in.
Top-down, of course. I'm hoping for someone with a better perspective than mine on what fraction of RA patients are well-served by conventional and inexpensive treatments to help translate between prevalence (something like 4 million US and Europe) and addressable market.
There isn't the breadth of evidence you'd like, but so far it looks likely that a degree of JAK-2 inhibition contributes to preserving joint structure (bari does it well; Xeljanz not so much). That's a key issue. Bari's safety profile is extraordinarily good, and until you have phase 3 results you have to presume an average safety profile for potential competitors.
Market size estimation here is harder than dividing MF into indolent and active.
Something I'm reluctant to do. Anyone care to make a bottom-up estimate of the RA market potential of baricitinib? I don't think the annual treatment price can be as high as for a biologic (so let's say an absolute cap of $80K). It will compete strongly in the realm of the biologics (a $20 bln market), and somewhat in the equally large "other DMARDs" realm.
Top down, I say that should come out $6-10bln, with about 23% going to Incyte. I suspect that a bottom-up number will be lower, but well above the $1-3bln (25% to Incyte) range most analysts seem to guess.
Gonna be hard for this to proceed. Myriad has already given the plaintiffs what they asked for, and announced that anyone else who asks for the same thing will get it also.
Obviously this is an attempt to get Myriad's database piecemeal. Its effectiveness depends on how many patients participate by requesting reports that include both deleterious and non-deleterious mutations. That doesn't figure to be a huge proportion. Last CC, Myriad claimed that their lead over public databases was continuing to increase. At its most extreme, this would stop the increase in the lead.
They COULD drop the other shoe and sue for disclosure of the full database on the grounds that it was the fruit of an improperly obtained patent. No large clinical laboratory could actively support that effort because of the terms of prior settlements. That is, ACLU couldn't find a plaintiff able to say "We can serve the public if this is disclosed." Really, it's hard to see anything short of Congressional action taking the dispute farther. Oxymoron alert.
The stuff on capmatinib is all early stage, and confirms that it has a better home with Novartis than with Incyte. This is an agent that really ought to be good for something, but needs to be tried in a lot of ways before settling on a path to registration.
I'm guessing that a lot of insurers [read: everyone except Medicare] will grant negotiated coverage for ruxo in high-genotypic-risk, but early stage, MF prior to the label reconsideration. I have the impression that most MF patients have genetic markers assessed, so while FDA is likely to require that as a companion diagnostic, it won't be much of a barrier to usage expansion. Ultimate ruxo market has edged over $2.5 bln (and that's assuming that we're already seeing use vs GVHD), with no credit for alopecia or for palliative use).
There's a beginning on getting negotiated coverage in ET. The illness is generally too mild to justify use of a very expensive drug with some risks attached, but there could be noticeable use (especially if Incyte follows Novartis in making the 5 mg pill less expensive than the other sizes). Developing an ET-specific drug might pay.
The full abstracts don't give us much. Life extension in the Comfort extension is as expected; safety perhaps a little better. Incyte IS going for label expansion.
The Janssen study on Im includes a very early safety read, which may be interesting.
The key drug in this is a treatment for eczema / atopic dermatitis. (The marketed chemically related drug for nail fungus doesn't seem to be a big issue, although ability go through he nail is interesting) Makes the possibility that bari may be useful against this indication marginally more interesting (still questions about economics).
I'm tempted to hit the books and write at length on this, but it's a good day for gardening. There seems to be an idea in The Industry that an eczema drug is also a lead toward a psoriasis candidate, and the latter is a big money disease.
We had abstract titles a while ago. We'll be getting full abstracts (I'm not sure when) before the meeting. I don't think we get anything on late-breaking presentations until the meeting starts.
Whoops. Where ASCO might matter is that increasing evidence for the benefit of early Jakafi use in MF might modestly boost sales. There are still plenty of physicians waiting for disability before prescribing it.
It's a lot more (or should that be less?) than that. Investment time scale has shrunk. That's why the loss of the PaCa prospect was so damaging (although I STILL think there's a palliative indication to pursue). Ruxo sales growth has gotten complicated--it was hard enough to understand when there were just on-label MF and PV. We simply don't know whether GVHD is present or future use.(and I personally think that since cowboy oncologists do more allogeneic stem cell transplants, it's present use). Pipeline? first, the timing on bari approval is a mystery (regarded as a breaktrough, approval could come in August; regarded as a risky drug for a mostly-healthy population, it could be delayed until April). And for unknowable reasons, most analysts project a peak market for bari in the $1-2bln range (I consider $6bln a low estimate). Most prominent candidate after bari is epac, which is useful pretty much exclusively in combination with other drugs; commercially confusing. But that may not be relevant anyway, because it's beyond the time horizon.
On top of all that (or maybe driving the time-nearsightedness) is fear that government over-reaction to the recent aggressiveness of drug pricing may shut down the whole game. And with a piece of Iclusig, Incyte is closer than ever to the storm track there.
Still, with complete failure of Incyte off the table, and a no-air price (existing Jakafi business + clock running on bari approval + epac in phase 3) in the mid-$60s, INCY is a horrible short.
It is expected that the follow-up on COMFORT-1 will confirm that earlier Jakafi treatment has an enduring survival benefit. The study directly addressing earlier use of Jakafi than guidelines generally recommend now will also be interesting in that regard. Consider that about half of MF cases are presently characterized as too mild for Jakafi treatment. An independent read, in a study designed to highlight early treatment effects, confirming the COMFORT results would probably justify a label-expansion study. Nothing to send the stock upward, but not zero news.
I don't think we'll be getting anything about late-breaking abstracts. So we may not know for a while whether any of the joint studies has given rise to a poster.
This isn't the season for a company like Incyte to go up sharply. We seem to have gotten some benefit from the move of epac into phase 3; it hasn't shown clearly against the weak market background. The next obvious opportunity for a dramatic move is the July/Aug CC. Higher-than-expected Jakafi growth would tell a strong story of higher-than-expected peak sales.
Another nibble at the edge: next meeting that "everyone" goes to that hasn't released abstracts yet is ESMO; mid-October. Abstract submissions due abut now. So I don't expect anything earth-shattering. Late-breaking deadline is late August, so we may get first reads from some early-phase and open label trials.
Have to call the YoY Jakafi growth a disappointment (gimme lots more such disappointments, of course). The thing is, as often repeated, you expect the April Q to be weak for an expensive drug, and a year ago it didn't look weak. That was probably because PV was catching fire back then. QoQ this year is what you'd expect. Tone of comments certainly left analysts expecting 15-20% QoQ come August. We could still be talking about trailing twelve month sales of "only" $1.2bln a year from now. It wasn'r said outright, but it was sure suggested that the MF survival improvement is starting to show in the sales.
Another random reaction: with prevalence of GVHD only about 150% of incidence, that speaks to a MUCH more fatal disease than I thought. Sometimes oncologists get very sunny-sounding when patients live a little longer than they used to, and an outsider like me can miss the degree of desperation. And after all, you get to a heterologous stem cell transplant by being desperately ill to start with. The death certificate can say a lot of things other than GVHD (A friend died of opportunistic infections after incomplete engraftment. Certificate probably said leukemia contributed, but if they were running high doses of anti-rejection meds [permitting more infections], I don't know. And even if meds were listed as contributing, I doubt the reason would be given).
Working the edges: remark that money tentatively earmarked for diabetic nephropathy participation has been released. Add to Lilly's remark that several [unnamed] early candidates or diabetic nephropathy have been abandoned, and I'm guessing that this high risk / high reward possibility is off the table. That's good for the stock price. Looking at what Lilly's up to, they are starting a phase 2 of bari for atopic dermatitis / eczema (those are not absolutely always synonyms). I think Incyte has to decide whether to participate after results are available. Also, Lilly is starting a trial of bari vs GVHD. Interesting: bari is less toxic than ruxo, but theoretically you would think that the mechanism of action for this indication requires presence in marrow--and low marrow penetration is exactly why bari is less toxic.
I didn't think that was between the lines. Incyte's near-term need for a European presence is in setting up clinical trials (the slant toward specialized institutes makes it easier to do trials on rare diseases in Europe). But they're getting a sales organization too, and the earliest I can see them needing that for Incyte branded drugs is over a year away. Still, it takes most of a year to build one from a standing start, so as long as they can break even while they wait, sellers are a comfort to have.
What he likes, I'm inclined t dislike. Stupid prejudice, I know. The Iclusig business is a political problem, although it probably won't itself get Incyte called before Congress (they'll go after the US marketer first, but if Incyte is there for another reason, Questions Will Be Asked).