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Incyte Corporation (INCY)

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82.62-0.61 (-0.73%)
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  • j
    jacosa
    FrontMIND, recently initiated, is a [nominally] 5-year trial intended to test inclusion of tafa + lenaalidomide as additions to the first-line standard of care for DLBCL. At around 900 pts spread over about 300 centers, it is well-powered and clearly getting clinical interest. With quadruple binding and multiple survuval-type endpoints, it is unlikely to finish early. The long duration makes the commercial importance sensitive to innovations in lymphoma treatment; in particular; reduced AEs connected with hsct or CAR-T treatments could greatly alter potential patient counts. Depending on things like duration of response, and what physicians and patients are willing to call "cure," a First-line treatment ought to capture between 2 and 6 times the number of patients of a second-line one.
  • j
    jacosa
    The Society for Investigative Dermatology posterss are up on the Incyte web site under Presentations/scientific presentations---https://investor.incyte.com/investors/events-and-presentations/default.aspx#module-scientific-presentations. Basically, no safety signal, but presented as low-key as possible. Discontent with existing treatments is as apparent as always It's hard to thread the time needle to get quotable journal articles immediately upon FDA approval WITHOUT appearing to be lobbying the regulators; I'm expecting all seven veils to drop with a full paper in a very top journal before June 10
  • T
    Tom
    so jacosa calls me a liarhe has never complained about herve but did so on friedman, why when the stock has done nothing under herve would one always ROOT for him?more salt for herve and jacosa wounds10.5 million loss on monjuvi in the q , down from 25 million last year, on top of 1 billion plus spent for the drug.....will never see a the return of the 1 billion wastedto go along with ANOTHER writedown in the value of long term assets held....like shares in cala,agen,mrus,mor.....to mention 28 millionthen there is the 12 million fine from the govt for the following....https://www.seattletimes.com/business/pharma-company-to-pay-12-6m-to-settle-kickback-allegations/?utm_source=RSS&utm_medium=Referral&utm_campaign=RSS_business herve has an awesome track record......as an #$%$..and lining his pockets and cares zero for the shareholders
    DOVER, Del. (AP) — A Delaware pharmaceutical company has agreed to pay $12.6 million to resolve allegations that it violated the federal False Claims Act by paying kickbacks. Department of Justice officials said in a news release Tuesday that the...
    DOVER, Del. (AP) — A Delaware pharmaceutical company has agreed to pay $12.6 million to resolve allegations that it violated the federal False Claims Act by paying kickbacks. Department of Justice officials said in a news release Tuesday that the...
    www.seattletimes.com
  • j
    jacosa
    Deep breaths.

    Something noticeable on today's call: usually, in the Q&A, HH manages the "around the horn" of directing parts of questions to people answering them. Today he didn't. Barry and Steven shared that job. It wasn't bad, as such, but somehow it felt less organized.

    Given the the question of a class-of-drug warning, crossed with the hot-bloodedness expected of a Frenchman and an elite athlete (here I may be making a mistake in believing Tom...is HH REALLY an outstanding footballer?)...anyway, it strikes me that tempers may be thin over "two large trials show a reduction of infections and no excess cancer with rux cream; systemic rux is ANTI-thrombotic; why the [inert some very colorful French language] should we agree to a boxed warning about infections, cancer and inappropriate clotting!?!?" You must not, by gesture, posture or tone of voice slur FDA 6 weeks before a PDUFA target.
  • M
    Maddison
    how does Herbie keep his job? Stock price down substantially in past 3 years while market is at all time high...?????
  • j
    jacosa
    Can't say I'm delighted, but it coulda been worse. Obviously, falling Jakafi volume is unqualifiedly bad. I believed Novartis when they said there was stocking in Q1 of 2020, so I believe Incyte when they say there was [less] stocking in that same Q. Worse pandemic impact in general is expected because the less serious illness PV is more important to Jakafi growth than to Jakavi growth. The sharp pick-up in Mar allows a bull to keep open the possibility that the full year target will be met. Barely-higher Monjuvi sales were more of a concern. MorphoSys will be presenting Thursday afternoon. While R/R DLBCL IS an extremely nasty disease, the initial course after failure of first-line treatment permits SOME delay in seeking second-line treatment. Pemazyre reports were EXTREMELY encouraging. Duration of treatment is still running longer than predicted, and profitability depends strongly on that. And before the tumor-agnostic trial program is off the ground, "carcinoma of unknown origin" is shaping up as a worthwhile target. Topical rux seems to be going well [time to see some journal papers, though]. LIMBER still looks on track to generate products by early 2025. The reminder that entirely new candidates are part of the program too was sharper than we've gotten previously.

    I thought I remembered HH doing the sign-off after the Q&A. He didn't today.
  • T
    Tom
    share price in the tanks for years now, only hh does 2 buys in 6 years, 10,000 twice, total compensation in those 6 years over 100 million, why bother at all scrooge!!!!
  • j
    jacosa
    Tracked down a meatier account of the allegation that was settled (from Reuters).

    "The Justice Department alleged that Incyte from 2011 to 2014 used the patient-assistance charity known as Good Days as a means to pay the copay obligations of certain Medicare and Tricare patients taking the expensive drug Jakafi.

    The charity has established a fund to support patients diagnosed with myelofibrosis, a rare, life-threatening condition that involves abnormal blood cell production and scarring in the bone marrow.

    But the government alleged that Incyte managers pressured the charity to provide assistance to ineligible Jakafi patients who had other non-myelofibrosis conditions including leukemia [jacosa note: this probably refers to GvHD, which is mostly caused by leukemia treatment] and another cancer known as polycythemia vera."

    Frankly, I'd do it too...and think of the settlement as a non-deductable charitable donation. Come to think of it, a friend has a Facebook fundraiser every year to cover his January drug cost bulge, and I DO make non-deductable contributions.
  • R
    RogerR
    ASCO June Conference abstract titles released this AM.

    Safety and efficacy study of retifanlimab and epacadostat in combination with radiation and bevacizumab in patients with recurrent glioblastoma.
    https://meetinglibrary.asco.org/record/201191/abstract
  • M
    Maddison
    12.8 million for kickbacks....just announced! How does Herbie keep his job after this?
  • M
    Maddison
    again I ask...HOw does herbie keep his job?
  • T
    Tom
    next plan so easy to see by herve spend 2 billion on a drug that will not go to market
  • I
    Irena Boga
    Is incyte for buyout?
  • j
    jacosa
    And after the meeting: It used to bother me that Christiana was too shy about talking. Well, she's graduated to the other common presentation of stage fright: repeating things too much. a SERIOUS ccompany needs a CFO who can participate in presentations, so whatever it takes, she needs the training.

    Many things were covered--arguably, the discussion of topical rux edged over the line into lobbying FDA. At least, nobody left with any doubt that the presenters believed in the safety of the product. Both presenters believed that most of the shortfall in Jakafi starts will be made up. After further review, recent Monjuvi sales still look...odd. Adoption of a novel treatment is usually led by academic centers. Monjuvi started like that, but now 70% of use is in community settings. Frankly, it's as if organized selling had been futile, and patient support groups are driving adoption. Something else that affects the rollout got mentioned: while the main course of Monjuvi treatment is straightforward, there is some complexity to initiation of treatment.

    I had hoped to hear something about duration of Pemazyre treatment. We've had hints twice now that patients are living longer than expected on Pemazyre. No question; no comment.
    The only thing I recall touching on LIMBER was brief mention of pars in a lymphoma context.
  • T
    Tom
    keep pumping the insiders with all the company PROFITS, is the PLAN

    Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2021 increased 38% and 26%, respectively, compared to the same period in 2020, primarily due to expenses related to the establishment of our dermatology commercial organization and activities to support the potential launch of ruxolitinib cream for the treatment of atopic dermatitis, a $13 million reserve related to a settlement in principle in connection with the 2018 civil investigative demand from the U.S. Department of Justice, and the timing of certain expenses. Excluding the impact of the legal reserve, GAAP selling, general and administrative expenses for the quarter ended March 31, 2021 increased approximately 26% compared to the same period in 2020.
  • j
    jacosa
    This virtual meeting thing is getting on my nerves. Nobody seems to be releasing abstract texts early...with no "going," they don't have to sell "you really need to meet the presenter" ahead of time. AACR didn't release abstract texts until the second morning of the meeting and SID is being at least as grudging. Still, those safety results can't help coming out by the end of the week, and analysts figure to be unsparing seeking management 'characterizations.'

    Money stakes of topical rux for AD are very high. A nice middle-of-the-road estimate for prevalence of the grade of disease addressed by the cream is a quarter million (actually increased as systemic candidates for treating more severe cases hit regulatory problems). Existing treatments sell for about $600 a month; treatment is intermittent. If safety stays 'clean,' rux cream is clearly better than "the $600 spread;" Call peak sales $4K a year for each of 100K US patients...well into the $hundreds of millions.
  • j
    jacosa
    Ahead of the meeting, ML has cut its forecast for the Monjuvi sell-in, although they still expect it to be accretive for the year. HH will not be presenting today, which I still take a a precaution against him saying anything to upset FDA about topical rux.
  • a
    anglesm
    What am I missing today that would cause the SP drop? Earnings looked good. No negative side surprises.
  • J
    Jason
    Ruxolitinib is gonna be a game changer for Vitiligo. I'm holding INCY til $150
  • T
    Tom
    so pray tell, how exacting did you come upon data/news that monjuvi sales were bad in jan/ feb