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Keryx Biopharmaceuticals Inc. Message Board

biomachine2006 11 posts  |  Last Activity: 15 hours ago Member since: Nov 16, 2006
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  • Reply to

    CC says interim couple of weeks.

    by mclim73 Sep 9, 2014 12:36 PM
    biomachine2006 biomachine2006 15 hours ago Flag

    "I told you so"

  • Reply to

    Sanofi, partner/BO, makes the most sense

    by biomachine2006 Sep 11, 2014 3:25 PM
    biomachine2006 biomachine2006 Sep 11, 2014 6:35 PM Flag

    LOL

    Correction on Roche valuation equation. Misplaced a $1B. LOL

    $1.7B peak sales X ~5 multiple = $8.5B market cap. (InterMune cash position ~$560M)

  • Reply to

    Sanofi, partner/BO, makes the most sense

    by biomachine2006 Sep 11, 2014 3:25 PM
    biomachine2006 biomachine2006 Sep 11, 2014 6:12 PM Flag

    Real negotiations don't begin until the FDA approval is in. Now Keryx has the leverage for an ideal price. Considering that FC has applications beyond ESRD (CKD, etc.), the added value needs to be reflected in the BO price. Pegging a deal somewhere between $28-32/share. Hope no CVRs associated with that.

    The recent BO of InterMune by Roche and the valuation calculation used to determine the BO price was interesting and sets some sort of precedent. Roche's calculation was:

    $1.7B peak sales X ~5 multiple = $7.5B market cap. (InterMune cash position ~$560M)

    BO price = $8.3B

    Obviously, KERX won't get that huge of an offer. Even conservative numbers.

    $1B peak X 5 multiple = $5B (bump the OS to 100M) == BO of ~$50/sh

    So, even $30-40/sh would be reasonable and considered cheap, especially factoring in CKD and other indications.

  • Reply to

    CC says interim couple of weeks.

    by mclim73 Sep 9, 2014 12:36 PM
    biomachine2006 biomachine2006 Sep 11, 2014 3:38 PM Flag

    Recent volume spike was the ATM shares being sold. Let's agree to this. If it is a "continue" on interim, an "I told you so" will be posted here. If it is a early stop for efficacy, a "congratulation to the longs" post. If a futility stop, "OMG, you are F***KED" post.

    Sentiment: Sell

  • -FC is going to become the SOC for HP (2 in 1 drug superior to Renvela – lost $$ for Sanofi)
    -Renvela sales to deteriorate upon generic entry (lost $$ for Sanofi)
    -Sanofi already has the sales force in place to market FC in US (easily replace lost Renvela $$ with dual acting FC)
    -Sanofi already has the sales force in place to market FC in EU (easily replace lost Renvela $$ with dual acting FC)

  • Reply to

    CC says interim couple of weeks.

    by mclim73 Sep 9, 2014 12:36 PM
    biomachine2006 biomachine2006 Sep 11, 2014 3:11 PM Flag

    Continue is the most likely outcome. PPS will drop to ~3.5/share. Market will perceive the lack of early stop as lack of robust activity.

    ATM was recently tapped ahead of the continue announcement.

  • Reply to

    Shorts

    by beachbumsoon325 Sep 8, 2014 6:07 PM
    biomachine2006 biomachine2006 Sep 8, 2014 6:26 PM Flag

    go to

    wwwdotshortvolumedotcom

  • Reply to

    Interesting

    by biomachine2006 Sep 8, 2014 5:05 PM
    biomachine2006 biomachine2006 Sep 8, 2014 5:14 PM Flag

    Doubt anything at ESMO on STS. Cut off for regular abstracts for ESMO was early July. LBA deadline was mid-August. It appears that the DMC review of STS is this month.

    "In our pivotal trial of TH-302 in patients with soft tissue sarcoma, we expect that the pre-planned interim safety and efficacy analyses will be conducted by the trial's independent data monitoring committee (IDMC) in September of this year."

  • biomachine2006 by biomachine2006 Sep 8, 2014 5:05 PM Flag

    Neither of the two recent analyst notes call/predict/expect an early stop.

    An interim "continue" in the works. Market perception is usually negative on lack of early stoppage at interim. Not long now to find out.

  • biomachine2006 by biomachine2006 Sep 8, 2014 1:55 PM Flag

    In a research note released Friday, Maxim Group analyst Jason Kolbert maintained a Buy rating on Keryx Biopharmaceuticals (NASDAQ: KERX) with a $24 price target, following today’s FDA approval of the company’s Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

    Kolbert noted, “Ferric citrate is now FDA approved, we assume a launch begins by year end . Our revenues forecasts begin in 1Q-2015, with $96 million for the full year. We expect royalties from the company’s Japanese partner to be in the low double-digit range, which we estimate at 12%. We base our US estimates on market of 500,000 end stage renal disease patients in the US, of whom 400,000 (80%) are on renal dialysis. Of these patients, 320,000 (80%) are taking a phosphate binder.”

    The analyst added, “We see additional catalysts to drive the stock over the next year, these include: (1) Announcement of Pricing and a new name, (2)data presentation at the American Society for Nephrology meeting in November, with additional data presentations and publications at other upcoming scientific meetings; these presentations should help drive market share and the message; (3) a Phase III trial for Zerenex in predialysis patients (P-CKD) is expected to begin in 4Q14; (4) EMEA approval in Mid-2014; Keryx’s filing for European approval in dialysis and predialysis patients was accepted in April 2014; and (5) an EU launch in individual European “Big Five” countries in 2H2015.”

  • biomachine2006 by biomachine2006 Sep 8, 2014 1:05 PM Flag

    In case it was missed.

    In a research report issued today, Brean Capital analyst Jonathan Aschoff maintained a Buy rating on Keryx Biopharmaceuticals (NASDAQ:KERX) with a price target of $26.00. The report follows and FDA approval, which was released last friday. The approval consist of ferric citrate (formerly known as Zerenex since the FDA wants a different brand name), which controls the serum phosphorus levels in CKD patients on dialysis.

    Aschoff noted, “We are not concerned by the warning for iron overload in the label, since ferric citrate alone did not show any iron overload in its trials, and we see the warning as rather for potential iron overload associated with the use of IV iron on top of ferric citrate, which makes perfect sense. Consistent with this view is the fact that nowhere does the label say that ferric citrate itself causes iron overload. Only 1 patient in all of the ferric citrate trials had elevated iron in the liver, and that patient was on both IV iron and ferric citrate.” Furthermore he notes: “We see this label as little more than a highly conservative blanket statement on the part of the FDA to cover itself. Physicians are simply advised to assess and monitor iron parameters when using ferric citrate and IV iron, and they may need to reduce the dose of, or discontinue, IV iron therapy, which is the whole point with this differentiated drug. The ferric citrate label warning is not a call to perform extra monitoring of patients, since these patients are already routinely monitored. We note that even after the FDA warned back in 1Q07 that aggressive use of ESAs to raise hemoglobin to a target of 12g/dL or higher was associated with serious and life-threatening side-effects and/or death, ESAs were still used off label for dialysis and that use peaked even after the warning was issued simply because dialysis centers could substantially profit from their use. Only when the bundle came into play, another economic (as opposed to medical) item, did ESA use plummet because now it is economically advantageous to avoid ESA use, and the resulting excess use of IV iron can be seen in how ferritin levels have risen dramatically post bundle. We also note how all Genzyme had to do with Hectorol to outsell Zemplar was to price Hectorol a little lower and let the economic dynamics of the bundle do the rest of the work. It ain’t rocket science.”

KERX
12.99-0.49(-3.64%)Sep 22 4:00 PMEDT

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