A very reasonable evaluation for a non-follower.
For a follower, the year-end termination of Incyte contributions to the Baricitinib registration trials is a large positive (even if Incyte elects to participate in label-expansion trials, they don't figure to be as expensive). It is also more likely than not that at least one of the phase 2 trials will show enough promise to raise the "real" value of Incyte's patents. And of course, with Janus 1 continuing past the date of a possible halt for futility, the odds look good that Incyte's pony will learn another, bigger, trick (and since Jakafi is already marketed, oncologists could obtain it before PaCa went on-label)
Of course, due to the accounting choices, earnings are meaningless. The multiple of sales is the better number. Even that is iffy because milestone payments are on the same scale (with total ultimate milestones remaining from Novartis in the high 9 figures, a $50MM surprise payment wouldn't really be a surprise; chunks of that size from a total heap of that size are something between extraordinary items and recurring ones).
With formal trials underway, backers of that oligonucleotide drug are likely to be more restrained than they once were in their publicity attacks, a real reduction in risk of sudden price moves.
First: NICE is probably the worst thing about the UK NHS, and their coverage approvals are not an indication of value, or lack of value.
I went to the Genomic Health web site and read the evidence supporting oncotypeDX (they aren't satisfied to mix upper and lower case, they throw in italics.) ANYway, the test is comparable to Prolaris. The validation studies were smaller than those supporting Prolaris and the prognostic value was less marked. I would give a clear nod to Prolaris in the US market, where patients have a strong preference for aggressive treatment. This is partly because of the endpoints chosen in the studies--long-term prostate-specific mortality comes very close to being exactly what a counselor wants to be able to show a patient.
Nothing against the company, but their test is not BETTER than Prolaris, and MAY be inferior.
I swear, I wrote the whole 2 more paragraphs. Myriad would have been happier with no Gleason score criterion (Prolaris is meant to replace it) and with a change-in-PSA rather than absolute level criterion.
My tinfoil hat gets warm when I think about timing of this announcement.
According to the press release, reimbursement will begin Oct 15, so there won't be any large monetary impact this Q, nor full impact next Q (again, for the nth time, the immediate issue here is group practice guidelines rather than the actual money).
" the criteria of a Gleason score
As you suggest, neither platinum drugs nor PARP inhibitors offer much hope of a cure, but a few good months are a meaningful benefit. I don't know what the side effects of PARP inhibitors are like, but they must be significant for FDA to require companion diagnostics. Platinum drugs have cumulative toxicity, so when they don't work, they generally aren't given long enough to cause serious trouble--but you'd still rather not subject anyone to treatment unless there's a decent chance it will work.
This is getting more detailed--the distinction between cancer of the ovary and cancer of the fallopian tube used to be regarded as a detail, but degree of hereditary involvement and drug selection are now looking pretty different.
Funny story. Booking my own talk, I bought a few $22 1/2 calls, expiring tomorrow, on Tuesday afternoon. What with the blah CC and the weak Market, I dismissed them as a lost cause (Hell, I lose more in a bad session of poker). So guess what? I just sold them at a couple hundred bux profit. Nothing in the grand scheme.
Yes, MYGN has done recent M&A and has expressed interest in doing more. Whether they're interested in RGDX, I have no idea.
There's a bit of a mismatch between this highly-forward-looking analysis and the present market emphasis on cash, this quarter. Then again, a couple years ago when horizons were five and more quarters out, the same bullet points would have led him to give a much higher target.
That's the first explicit market size estimate that I've seen for epacadostat, although I can't imagine how you could defend it. Presuming that this has been chatted about among analysts for a while, it DOES show why analysts have been imputing value to the IDO franchise while ignoring more concrete prospects (And it's likely that Dr Friedman gave backgrounders that were based on such a market size; he clearly loves that candidate).
Comes out twice a month now. Posted schedule.
In Goldman They Trust, so I don't expect the big shorts to cover until the bull case becomes overwhelming. I expected the CMS determination before now, and that was part of my bull case. It'll happen "by" Oct 1 (and probably not a minute sooner). I expected a modest beat in Q4, and that didn't happen. I don't expect the road show to make much of an impression either, because part of the current market insanity is excessive focus on the immediate term, and even the fastest things discussed won't turn into dollars in less than six months. So that leaves us without a real catalyst in sight. Still, what with the seasonal pattern of recent years, I wouldn't choose to be short Myriad mid-December to mid-January. There's a bit of extra urging there, because if the remarks about high-deductible insurance are correct, second and third Qs ought to be when "women's health" earnings get talked about.
As I write, up almost 6% against a catastrophic market background (Dow off 205)?
The CC was pretty blah as far as actual results (met the [lowball] management and Street forecast; essentially flat forecast for next Q and FY although with escapes marked for possible positive developments)
I'm guessing that it's the reiteration that the short case is dead. SOME people still believed that without the BRCA gene patents, other companies would swoop in and take away Myriad's business, or at least compete so effectively that there wouldn't be money to be made in it. So while it wasn't a spectacular call for most of us, the non-declining hereditary cancer revenue and the slight recovery of academic testing volume were drops of poison in the ear.
I guess the rapid growth of Vectra DA, even from its tiny base, is a concrete positive.
And as I finish writing, MYGN is up a bit more.
I was disappointed. While the bear case remains dead (that's the thing about death; it's permanent), there wasn't anything stirring for the bulls. The best short-run news was that even though CMS approval for Prolaris was delayed Yet Again, there is now a specific date, and a promise from CMS that the terms of the LCD will not be more restrictive than the proposed coverage that's long been on the table. I'm Not A Lawyer (tm), but the case for retroactive reimbursement looks on the surface like it could succeed; that would be a nice cash gift, but of course it wouldn't replace the prescriptions not written for a not-covered test.
Definite feel that since they couldn't make this quarter look impressive, they're tuning guidance to increase the chance of an impressive future quarter.
I hesitate to activate any bears, but among repeat posters *herbst* has the greatest likelihood of knowing "actual" whisper numbers. What would The Street regard as a miss or a beat for Q4?
I re-read the transcript of the last CC, and it was pretty clear that we had the custom of management forecasting a lowball number for the new president, and analysts pretending to accept it. Thus, I'm pretty sure that 41 cents a share, while literally high in the forecast range, would be received as a miss. My re-reading nudges my expectation up a fraction (the business hurt by weather in Q3 was particularly high-margin; if academic testing continues its recovery, well, that's also high-margin). How would 46 cents be taken?
Mr Rotunda was never magic, but he IS a pawn guy with a great head for business. I fondly remember his rollout of installment loans (gradual, with plenty of mistakes made early when they weren't disasters). Well, that business won't come back, but he won't go overboard on anything just because he likes the idea. But I don't know how much influence he has in today's EZ.
There's another problem, and it's the one I think Mr Rotunda is best suited to address: the biggish number of ...call 'em retail-model stores. Middle-middle class and better zip codes. Inconspicuous "merch in" counter, only the most attractive stock easy to look at. (Mr Rothamel's 'future') You COULD close 'em all, but the economic truth is that they serve a market that USED to have good access to small loans, and doesn't anymore. I'm not a great businessman myself, so I don't know what to do. Perhaps Mr Rotunda does.
The purpose of a BOARD of directors is to separate the good ideas from the bad ones. With most owners of the company having no other form of influence, lawsuits are the appropriate response to the board having allowed the Cash Converters mismerger, the over-sloppy Crediamigo deal, the online lending fiasco and the nasty surprise from A&B...while letting Mr Rothamel ignore the messy core business. (As I said, I'm no businessman, but I called out the worst problems in real time. Board members ought to have seen them too, and stopped them or resigned).
Yellen isn't stupid. A "real" rate hike would cause immense damage. Those employment numbers the talking heads claim seal the case actually came in below expectations, and there was no wage increase. The nominal unemployment rate remains a beneficiary of low labor force participation. Furthermore, with the collapse of capital investment in the US (we DO build enough condos, but we don't build many factories), an inflation rate well above the 2% nominal target would be beneficial (at least up to 6%, and so long as it's accompanied by low interest rate spreads, permitting relatively easy control). So we might maybe see a gesture like raising the Fed funds target to 0.25% flat (from the present 0-0.25%) (it's effectively a hair above 0.25% now). We might even see a small increase in the Fed bid for overnight funds (actually, eliminating the Fed offer and raising the target would be a nice non-increasing increase). But y'know, the analysis is pretty clear that a little stimulus works better if bankers think you're planning hell-for-leather stimulus forever. For everyone not on the Forbes richest list (and for a fair fraction of those on it), a continued "We're waiting for signs interest rates should go up" is the most beneficial policy. And Yellen has shown that she can take some heat.
Amusingly, I just received a sector report from BoA/ML concerning this issue. The essential message was that while "everyone knows" bio/pharma is interest rate sensitive, that mostly applies to the small players. For the big players, the correlation goes a bit the other way (this is not such an uncommon behavior, since rates tend to rise in good economic times).
Since Incyte's product and upcoming products aren't particularly subject to a good or bad economy, we should be more on the small player side. But the projected Fed action, when it comes, (and September doesn't make sense, really) is still pretty small.
I don't think bio/pharma is that sensitive to China, so that doesn't explain the washout. But when you ask who is most sensitive to interest rates, our segment comes near the top. I think we're seeing a magical over-reaction to an expected magical even-bigger over-reaction to an imagined rate hike by the Fed. Never mind that the dollar is clearly too strong for the good of the US economy, and a rate hike would make that worse. Don't try to explain how a roughly 30 basis point increase in the effective Fed Funds rate would affect non-bank players (most likely first rate increase is 25 bp addition to the rate banks receive on excess funds held at Fed)
This can go on for a significant time, but when you look a little farther ahead, completion of the RA package and likely success of Janus-1 are much bigger for Incyte (quadrupling medium-term addressable market)
They didn't say. Analysts didn't ask many questions. The only issue really probed was the expected course of the PV uptake.
There WAS a somewhat theoretical question about whether a successful trial might lead to progression of a drug candidate to a new stage without prior publication of the data justifying it (yeah, they might go ahead).
I'm seeing blurbs about an ESMO (end of September) presentation on '360+Yervoy in Melanoma. It's before the end of primary data collection, so I figure this can only relate to the open-label (mostly phase 1) part of the trial. In general, nobody rushes to spread bad news, and we know that the study is ongoing, so this won't be a late "Why we abandoned the combination 2 years ago" presentation. So I'm hopeful that there will be minimal synergistic toxicity (a big concern with checkpoint approaches) and at least some evidence that efficacious doses were reached.
Primary completion of the double-blind part of this study is expected a month [+/-] behind Janus-1.
This is really a response to your latest in the CC topic, but since it is getting away from strictly talking about the CC I'm putting it here.
I'd run the numbers carefully before intentionally taking assignment. But yeah, once you have them it seems worthwhile to keep them.
I'm presently margined enough to want a good short-term reason to take on more. But do I lighten up on Incyte, Myriad (short interest of half the float, AND likely to post an upside earnings surprise in only a week) or my package of airlines (with these oil prices)?
On present results, I could see Incyte staying in a $105-125 band until the next CC.