This CC requires more tea leaf reading than usual. Nothing was said about Janus 2. I would expect that if management had any fear that Janus 1 might fail, there would be something about the backup study.
Non Small Cell Lung Cancer. Get used to the initialism.
It's being mentioned as the natural next working target (after melanoma) for epac. I don't know about that (I'd prefer a cancer with more folklore of spontaneous remissions--kidney cancer). But we might as well think about what it is.
Prevalence of about 380,000 in the US in 2012 (vs maybe 10,000 for MF). Somewhat more lethal than intermediate risk MF. Heterogeneous disease, with a significant subset of tumors having highly differentiated cells (=attractive for immunotherapy), but most not so outstanding. "Cancer toxicity" fairly common, and a bad prognostic factor.
Total possible market size ~$25bln. (don't even think about getting all of it). Main point is that competition WILL be brutal, and extensive trials will be needed to document situations particularly favorable for that particular drug [combination].
Nice catch. Lowballing is part of Myriad's culture. Our memories of it have faded over the last 3-4 years. If I was Mr Myriad, I'd be spending noticeable amounts of money seeking catch-up reimbursement for Prolaris and re-categorization of Vectra, so there might be a blip on the wrong side, too. I like the chance of success for Prolaris catch-up, but with complex companion diagnostics just entering the picture, I expect the fight on Vectra to continue--ultimately, $trillions are at stake. In the medium term, Myriad probably does better to roll with that punch and to bill interpretation of tests separately from the tests themselves.
It's lovely to be in an era when adverse events are important in choosing among competing effective cancer treatments. And the preliminary indication is that epac is notably safe. Again, let's see more.
Usual request: stuff mentioned on the CC, slides, associated statements. Not for personal discussion or stock price talk.
The results look basically in-line, with perhaps a little less Vectra growth than I would have hoped for. Big gain in "Pharmaceutical and clinical services," which I read as Lynparza qualification. 'mcuriousaouthe decine in operating expense, which seems just a little large for having finished the change-over to myRisk.
One thing I'm hoping was a mistake. It sounded like Janus 1 was included in trials where the reporting dates are "event driven." I'd like to be hearing topline in the Feb CC.
As usual, please keep it clean. In particular, the bouncing stock price doesn't belong here.
This one has a lot going on. Very nice breakout of PV growth; it really seems to be taking over. It looks strong enough to suggest eventual market size larger than existing estimates.
The pan-PIM inhibitor came out of nowhere and into phase 2. It is potentially a huge market, but we don't have the sort of warm-up I'd want to set an enthusiasm level.
Glad to see the alopecia areata trial, and even glsdder to see it not turn into a circus.
I think that we are starting to miss Mr. Daly. There was an obvious move toward greater secrecy, and I thought I detected a whiff of lowballing for future Qs. This bears watching.
Apparently, when discussing either a combination of an approved and an unapproved drug, or even when discussing a drug combination including an approved drug which is hoped to go on-label, it's correct to refer to the approved drug by its generic name rather than its commercial name. I'm not inclined to do that, but maybe in the future...
Timing suggests that the bad reaction was to stuff in the raw report, not on the CC. The YoY growth of Jakafi sales (65% vs 69% last Q) was down, and may have ticked badly on somebody's checklist (huge growth vs huge growth...but don't look for sense). Also, the increase in number of phase 2 studies may have some analysts foaming at the mouth...they were already saying that Incyte is running into a financing wall.
I don't follow Genomic Health at all. I looked at their web site, and they seem to be well positioned for the companion diagnostics business, which may become huge. I sure wouldn't care to bet against the Bakers. If what we heard about Myriad's tests for cancer aggressiveness in the investors' day presentation holds up, it's unlikely that anyone else's tests for that sort of outcome will be superior; there may be a fight based on details. Myriad is extraordinarily good at reporting test results, which is an advantage, but many people HATE the company that "claimed it owned your DNA," which is a disadvantage.
Myriad's CORE core business, testing for cancer susceptibility genes, probably can't be attacked for a long time.
Anyway, the big money part of companion diagnostics figures to be reminiscent of the BRCA testing business: lots of subtle variations in alleles that can only be interpreted with a curated database. It'll take a long time to sort out the winners.
I'm pretty sure that the AGEN interest is carried at cost.
The most interesting thing in the CC is likely to be Jakafi sales. The boost from putting dose titration on the label has probably faded, but the uptake in PV is probably coming into its own.
Also, there should be some discussion (in response to questions, if not volunteered) concerning the mechanics of getting epac licensed and sold. There may be some comment about Incyte participation in the Lilly trials of bari against diabetic nephropathy--my personal prejudice is that it should be done: it figures to be less expensive than participation against RA was. The potential payoff is a lot more, but the risk of failure is enough higher that I could see not participating, too.
I remain skeptical about cancer immunotherapies. Melanocytes are "different;" spontaneous remission in melanoma is well established, at least in folklore, so I'll give some credence to Keytruda + epac for melanoma. it'll take pretty spectacular early results against other advanced cancers to get me excited.
Apparently, the gardening meaning of 'brown thumb' has come to dominate the Little-Jack-Horner-inspired meaning that was just as common back when I was a working chemist. A purple thumb would mean clever analysis of good data...
I'd like to hear any estimate better than my "brown thumb" guess (BACKED out from sales figures and an equally stinky guess about effective pricing) of 7000 patient-years.
I have identified with pretty good assurance what FACTMED is delivering.
I filed a FOIA request with FDA for all records relating to Jakafi in the FDA Adverse Event Reporting System relating to Jakafi. The format of the free level of response is exactly the same as the information delivered by FACTMED, including ALL CAPS and the rather unusual "% of cases containing this event." The FACTMED version seems pretty old.
The form for making such a request is easy to find on the FDA web site. A more detailed report, including age, sex, other medications taken. form and dose for the drug, and date of report is available for about $60--instructions for requesting it come with he free report.
Mebbe $400. But things always take longer to start and then go faster than I expect, and I'm not good at allowing for that. But let's get that extended safety read first, and see the Janus 1 results. It'll be a while until we see the mechanics of how co-checkpoint drugs make money. And in 2 1/2 years, we may even have to count some of the newly-clinical stuff in valuation.
Some people talk about perfection--that would be some life extension and dramatic QoL improvement from Janus 1, followed by positive results in the trials of bari against diabetic nephropathy. Ten year target of infinity. I don't require perfection.
And I see no reason Baricitinib shouldn't have a third of that in 2 1/2 years, with an equal amount carved from the other 4 TNF antagonists (Humira hits the sweet spot among the group, which is why it was what bari was tested against).
The more-detailed safety read at ACR (we won't get the "twenty-seven 8 x 10 colored
Glossy photographs with circles and arrows and a paragraph on the back of
Each one explainin' what each one was" until the journal publication) is going to be an important hint at the future. My guess is that the slightly-worse AE performance was either due to more experience at combining Humira with methotrexate (as somebody else suggested) or to an inability to tune dose to kidney function within the trial protocol--but that's what the data is there to determine.
Well I agree with the first sentiment. Read it. My position has aged well. The other side, not so much (Geron, for instance, is smaller than when I called it a stub) I remembered the Mayo demo series as well as any of the Geroniacs. The stuff that has come out since (In particular, the NEJM issue of Sept 4), well, you should read it carefully and test just as carefully whether the evidence provided does or doesn't support a given position. Most of them thought the MoA of Imetelstat was settled (and "Nobel Prize winning") All I said was that there was doubt, and lo, the editors of NEJM said the same thing. I was challenged more than once on the hundreds of infection deaths supposedly caused by Jakafi. Well, if they were real, the FDA would surely have called for a response by now. My favorite debater's trick is knowing my side "well enough" and knowing the other side better than anybody arguing it.
I don't see that saying that I had been lousy at debating because I stayed within what my authorities supported translates as self-professed debate skills.