I had a distinct impression that there was maneuvering for an introduction late in cal Q1 of '15. There are financial reasons to like that timing, but both advent of a possible competitor and better-than-expected results on Son of Pirfenidone work against that. When the dust settles, we may understand the early launch, but now it puzzles me.
You might think that better than 100% sales gain YoY, a plausible story about why that should accelerate in existing territories and imminent opening of a potentially more-lucrative new territory would be enough to push ITMN up for at least a day. I mean, the evil bogey of $60MM quarterly sales in Europe and the meaningful bogey of $75MM quarterly sales to pay for normal operations ought to be bagged within the year. You might live in Oz, too.
I think the big negative to the stock price was reported progress on Son of Pirfenidone. More potent, easier to take, greatly reduced side effects, and talk about a Nephew of Pirfenidone, too. An important pipeline product makes the company harder to value, which makes a buyout less likely. The scleroderma project has the same general effect. So I think the buyout soon Soon SOON crowd are dialing down their holdings, and I think there are a lot of them.
I don't think we're suffering as much from the other bane of investment in drug developers: the transition from being priced as a pure pipeline to being priced on results. Even the dream outcome of present initiatives, a company with a small stable of drugs combatting a wide array of diseases characterized by fibrosis, wouldn't look like a REAL drug company..."I can't define it, but I know it when I see it." It just seems like a company that would be priced on ultimate sales rather than contemporary earnings (possibly because it would still be an attractive target for other pharma, private equity, or any other predators out there)
The actions announced are compatible with continuing independence, but I didn't hear anything incompatible with a business combination either. Interesting times.
In general, holders of converts don't want to hold stock (usually as a policy matter). They tend to want to hold bonds, so a negotiation with holders leading would be expected to result in a new convertible issue. This COULD be a special case (I have a rollover IRA which as a policy matter I don't want holding stocks, but I made an exception for ITMN).
Intermune has the cash to begin the US rollout, with good prospects of financing it internally, if the company doesn't pursue SoP. But staying independent without SoP makes no sense to me. So my best guess is that they're pretty literally investigating all options, with a target date to do SOMETHING by cal Q1 of '15.
You may have missed the management transition. New dog with old name, so we just don't know its character yet.
I'm starting to be hopeful.
The first Baricitinib p3 is indeed finishing up quite soon. But I don't know that Lilly will publish the result, and I don't know that any result could cause a favorable reaction. The whole set of p3-s interlock, and protection of joint structure is both the most important measure and the slowest one to demonstrate.
For once, the Zack's summary is good for something...even though it's wrong.
We're getting this mixed price response largely because the grown ups are focused on product revenues, but everyone notices earnings. And product revenues beat pretty much every upward-revised forecast, while the net loss was a lot bigger than expected. This despite the fact that every other line item was pretty much as forecast--with one exception. Everyone, and I mean that pretty literally, expected NICE to approve marketing and pricing of Jakavi in The UK by now. If it was Incyte dealing with them, you could say "Ah Ha! Ham-handed business amateurs can't deal with sensitive regulator guys." But Novartis is doing the contacts there, and this ain't their first (or tenth) rodeo. So there's a big (relative to quarterly numbers) hole in contract revenue, and consequently a miss on earnings.
Where Zack's goes wrong is in saying that the high YoY (but steady QoQ) SG&A number is due to commercialization activities for Jakafi. Well, maybe 'wrong' is too strong. That is absolutely what made the SG&A big in Q1 (a LOT of physician contact about dose titration and related issues). But what we're starting to see now relates to not-yet-approved uses of Ruxo (recall--trademark name should only be used for on-label use). In particular, core staff are being prepared for the push into PV [and management said as much on the call]. That mostly matters in forecasting: SG&A will increase, possibly by as much as $30MM/Q by a year from now. You double your addressable market, you increase SG&A. And if you need a fast sell-in for a drug, you generate an SG&A peak around the introduction.
Our $60MM milestone may have to come from Italian approval (they DO get around to things, eventually). I have a sick feeling that the delay in UK may turn out to be NICE making a stand against the stupid and evil law they operate under. A by-the-rules delay here kills relatively few people; none immediately.
I think Incyte is at a stage of development when sales are very important to investors. That means there are fewer bullets than you think you see. Basically, Ruxolitinib and '360. On a fundamental basis, I don't see much argument against a new "trading range" period. Jakafi for MF sets a floor. Upward pressure comes from Jakafi for PV, the possibility of Ruxo breakthroughs in non-Incyte trials and progress of Baricitinib toward market. But this is supposed to be about what we learned from the CC, and what I mostly learned was that nothing surprising is likely to happen soon.
Usual requests: no praise or sniping directed at other posters. There are plenty of topics to do that in.
Little in the way of meaningful surprises. Basic financials a bit strong on Jakafi sales but otherwise pretty much as expected. Little bits of housekeeping changes in deep pipeline R&D (most important is the ocular toxicity signal in a "non-rodent" seen with the #2 JAK-1 selective candidate. This would be a total non-event except that with JAK inhibitors so new, any time a member of the class shows a signal, there's a flurry of investigation of whether it's somehow an on-target effect)
This is the 2nd anniversary, more or less, of the "Bad conference call" and I didn't pick up anything that seemed self-destructive.
The convertible bonds were taken off the table. If continuation of the company essentially as-is was the only thing being considered, there would almost for sure have been a new debt issue by now.
I'm guessing that today's drop reflects disappointment that the company expects to be independent long enough to HAVE an earnings release date.
Well, except that while RA is life-long, it is incorrect to say that it "mainly affects the elderly." Onset of rheumatoid arthritis tends to be around 25 years younger than osteoarthritis.
This is only huge. FDA rarely allows results of post-facto analysis onto drug labels. Detailers can now point to the diverging curves and suggest earlier use of Jakafi in minimally-sick MF patients.
Consider the difference: before, salespeople were only allowed to tell physicians that if they contacted the company they could get more references to clinical data. If FDA had allowed references onto the label, the salespeople could have carried reprints with them, but they'd have been on shaky ground discussing the findings. With the curves on the label, they can basically tell the whole story.
And certain annoying people who keep saying "It only relieves symptoms" can choke on their own bile.
#1 is hard, but just barely possible. #2 is unlikely--FDA doesn't schedule stuff for ANYONE's convenience. #3 is pretty much impossible, as Italy is on vacation and NICE, again, isn't scheduling actions for our convenience.
Other than that, I think #s 2&3 are pretty much non-events. Europe ex-UK and IT (&ex the already onboard DE and FR) is on the same order of size as either one of those, so the rollout can keep going without them; the $60MM is modest next to the numbers that are really interesting to people. And the money question for PV is whether adding the less-serious indication can increase the dollars of sales, not whether it can be added at all.
What (if any) sales use can be made of papers showing a MF survival benefit for Jakafi is potentially of great interest; any kind of recognition of post-facto analyses would have symbolic importance.
There's a curious tripwire hiding somewhere--some number of country approvals of Jakavi starts up a reverse royalty to Novartis, which I don't people have front-of-mind.
Small but meaningful adjustment: the control arm did 6-fold better than in RESPONSE. We don't have a "normal."
I saw 2 faults with Dr Paul as CEO. The larger one was that he was a poor public face for the company. Given that HH's biggest job was to be a good public face, it isn't fair to slam him for some happy talk that everyone else has long forgotten. (The other fault I saw was that he was in love with the IDO inhibitor to the exclusion of the rest of the pipeline)
I have a bone to pick (preferably their C2 or C3) with the consultants who have made stock such a large part of executive compensation, but basically, you're going to see only sales, never purchases, from insiders of companies following that course.