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JJSchaible

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  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    I've spoken with AMRN IR. My contact mentioned that the company had previously considered an FT application for this indication, but the concept was "not supported by the FDA". So reading between the lines, he seemed to be saying that they have NOT YET filed a FT application, given (old?) advice that it would not be favorable.

    But today is another day. Don't know when they had the first dialog on this topic, but clearly the FDA review team has turned over at least once. And if Amarin choose to withhold an FT application out of fear it may piss of the Agency? Well...with 3 SPA declination appeals and references to 1st amendment challenges...I think that is water well under the bridge.

    While it did not sound like they were contemplating such a move, I remain convinced that submitting a mixed dys FT application here (and publicly announcing such) would be a very useful tactic ...and actually required if AMRN is now to have ANY hope of an accelerated approval based on dyslipidemia as a surrogate endpoint for CV events.
    Sep 19 10:53 AM | Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    Scrying Biotech or JohnCappello,

    Do we as yet have any confirmation that Amarin ever applied for a Fast Track review on Vescepa for the mixed TG indication? I recall back when it was called Miraxion, it did get the FT designation for Huntington's but that would not be relevant here.

    The reason this remains at issue, as it cryptically was refered to at the Adcom, is to be considered for accelerated approval (at least under the former rules) an agent first needed to be accepted into Fast Track. I've repeatedly asked Amarin if they have ever filed the the FDA for such consideration for the mixed TG indications, but in spite of promises by their IR folks to get back to me, I've still no answer to my question.
    Sep 3 04:02 PM | Likes Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    I do like talking spinoff ideas for Ligand - what ever the flavor. But I'm not sure I follow your idea here.

    Most of Ligand's partners with performing royalties (such as Amgen with Kyprolis) would be seeking to increase earnings on Net Sales. Your proposal would have them decrease margins as they would need to pay higher royalties. It would also might increase LGND share count. LGND is actually trying to reduce share count, so that when they start the dividend phase of their existence, they can afford to pay out a meaningful rate.

    By the way, as you might know, I led the R&D newco shareholder proposal. The issue focused on how to provide capital for the R&D if one carves off the royalty biz, which lead us to the Form 10 R&D Newco / IPO, process. Such is not that dissimilar to what they are doing with Viking - though Viking is with a more limited set of R&D assets, and has not yet allowed Ligand for further reduce headcount as did my proposal.
    Aug 29 01:25 PM | Likes Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    Your option table is well out of date. For example John Sharp is no longer with the company, and thus these options are no longer vesting.
    Aug 29 01:11 PM | Likes Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    SPA,

    While I'll give you that $LGND's stock compensation is on the rich side, understand that such expense is proportional to the number of shares of the granted, as well as the gains in the stock. As $LGND has had a number of years now of exceptional growth, the amount of this expense has likewise grown.
    Aug 5 11:48 AM | Likes Like |Link to Comment
  • Update: Lemelson Capital Further Increases Short Stake In Ligand Pharmaceuticals As EPS Plunges 76% In Q2 2014 [View article]
    CaptisolFollower,

    Transcripts released on SA are notorious for errors, likely given the software used for production. Please not they are not produced by the reporting company or their agents. In a day or so, alternative versions will be released by other sites that have more vigorous QA/QC.
    Aug 5 08:22 AM | Likes Like |Link to Comment
  • Update: Lemelson Capital Further Increases Short Stake In Ligand Pharmaceuticals As EPS Plunges 76% In Q2 2014 [View article]
    OK, this is beyond "silly" now. You've moved to shameless.

    "$LGND reports, non-GAAP net income from continuing operations for the second quarter of 2014 was $5.2 million, or $0.24 per diluted share, compared with non-GAAP net income from continuing operations attributable to common shareholders for the second quarter of 2013 of $2.5 million, or $0.12 per diluted share."

    Yet you think this is a 76% decline? You're comparing apples and oranges... look at how the GAAP impacted in '13 quarterly revs given some of the last large income statement realization from long prior consummated deals (2007 sales of marketed products).

    Your claim of the company being "essentially insolvent" is insane, given today confirmed the company is now entirely debt free. Insolvent mean you can't pay your current debt...so it is IMPOSSIBLE to be insolvent if you HAVE NO DEBT.

    Your claim that Promacta is "going away" but the GSK 2Q earnings reported sales GREW 17% from Q2 over Q1 in the US. HCV has never been the largest portion of Promacta sales (which has been ITP) and the major driver of its future sales is Oncology related thrombocytopenia. If anything, the launch of oral Solvaldi seems to be helping oral Promacta, which is taking share from injectable Nplate in HCV, given the era of all oral treatment for HCV 2&3.

    By the way, R&D collaboration stopped being a material part of Ligand's strategy a decade ago. I should know. I negotiated the last true R&D collab at Ligand (SARM with TAP) in about 2001 (that collab phase of that deal wrapped in ~2006). Since then, $LGND deals have been predominately sublicense agreements and program out licensing. Not R&D collabs which required huge headcount to support and for which $LGND shared profits from such with third parties.

    Now you have raised some valid issues. Some of the past deals have raised eyebrows. And historic dilution driven to acquire new revenue streams has been high. But over all, you clearly are just talking your book, and in doing so show you don't even have a passing understanding of the $LGND business model or the pharma industry in general.
    Aug 4 03:55 PM | 4 Likes Like |Link to Comment
  • Amgen's Focus On Kyprolis Data Shows Need To Aspire [View article]
    Interim data out today showed ASPIRE has robust PFS:

    Kyprolis ® (carfilzomib) for Injection in combination with Revlimid ® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001).

    Just as important, safety reported in line with label. Not only a huge win for $AMGN, but also for $LGND (given royalty rights), which has been a fav short by those who expected negative results in ASPIRE.
    Aug 4 12:10 PM | Likes Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    Small Pharma Analyst,

    Amgen's report of strong 2Q growth of Kyprolis provides further support to the bull case. With the strong 2Q Promacta results, it should be a nice 3Q14 for $LGND.

    Also in Amgen's report, it was interesting to see the clear divergence of injected Nplate (0% growth from Q2/Q1 in the US) vs oral Promacta (17% growth from Q2/Q1 in the US). As Sovaldi ushers in an era of "all oral Rx" for HCV, Promacta has an improved competitive profile in those HCV pts who do still get treatment for thrombocytopenia. But I suspect much of the growth in Promacta is in Oncology Related T.
    Aug 1 01:57 PM | Likes Like |Link to Comment
  • Ligand Pharmaceuticals: Appendix [View article]
    To confirm what @Birdsnest reported via IMS data, this week GSK announced their 2Q14 sales of Promacta, the #1 source of near term royalty revenue for $LGND.

    Net Sales of Promacta in the quarter topped analyst consensus, with sales growth up 31% over prior year quarter, and suprisingly up in the US by 17% Q2/Q1 (were many feared a loss) and up 50% in ROW.
    So Lemelson, care to share how exactly you see sales of Promacta "going away"?
    Jul 25 01:03 PM | 1 Like Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    @pimmoban,

    The 10% WACC used by Roth is only used on performing royalty streams portion of the $LGND business. And note that other analysts already use much higher WACC (Cantor Fitz uses 13%, but consistently has way underestimated Promacta sales), Summer Street (15% WACC, but sill has a $91 PT). But I stand with those that believe that while 10 to 15% WACC might be appropriate for a high risk R&D focused emerging biotech, $LGND has not been an R&D focused company for years... it is a royalty streaming play, so has a much lower risk profile and much higher operating margins.

    Also, all the analysts honestly covering $LGND appropriately use additional industry standard risk adjustments for all projections based on programs still in development with partners...and no value for any unpartnered assets. And no one yet has any material value in their price targets for Merck's BACE1 for AD now in Phase III. If $LGND was only the Merck BACE1 partnership at any other company using standard probability of technical success, it would yielded an EASY raNPV of $400 to $700 mil alone.

    And while on the NPV topic, while I agree with you interests rates may not always be this low, but in the early years - key to any NPV analysis - no one in their right mind is suggesting rates will spike to anything close to 10%. So our read is that ALL NPVs calcs that use 10% over the next 5 yrs are massively underestimating fair market value.

    By the way, I also agree with biotech_maven that your static view of $LGND is rather naive. You make no allowance for $LGND to either add more NOLs via acquisitions of new royalty bearing streams, and/or advancing a tax inversion (though my bet is that it is with a UK firm to gain advantage of that country's patent box provision).

    Finally, you believe a mere 20 is the correct multiple on LGND? Seriously? That is the same multiple as that of the current S&P 500 PE Ratio is 19.71. However, given $LGND's fresh royalty streams coming on board, plus its total debt payoff and now start of the buyback, $LGND EPS is growing MUCH faster than the ave S&P 500. Heck, large cap pharma as a sector trades at 26.4 even as it only has EPS growth rate of 0.9%.
    Jul 25 12:30 PM | 3 Likes Like |Link to Comment
  • Ligand Pharmaceuticals - The Bull Case [View article]
    Having spent years at Ligand and managing several of these partnerships, LGND would disclose more if they could, but such information is nearly always covered by terms of confidentiality agreements with these partners, and many of LGND's pharma partners simply do not wish to have such royalty and milestone rate obligation information made public.

    Think about it... such info of expenses is key competitive info for drug manufactures. And also as soon as high rates of deal are disclosed, then such terms will be used as comps in negotiations with that company in other future deals.

    So such information becomes public mostly when it becomes a matter of public record or when it becomes material to one of the parties current financial reports. As such, many of the disclosed rates are those for products in late development or already marketed.
    Jul 8 12:53 PM | 2 Likes Like |Link to Comment
  • Quantum Fuel Systems: Inflection Point Has Been Reached, At Least 50% Upside Ahead [View article]
    Nice review.

    For the warrants, they shouldn’t be much of an issue till the $15.40 range. So far feverish short covering has overpowered all concerns of dilution.

    And yes LNG is losing favor to CNG, which as you mention plays right to $QTWW strengths. While LNG has higher energy density, it also suffers from wastage & ghg emissions from cryogenic leaking. But the real killer for LNG as an onboard surface fuel will be ANG, the next gen technology that allows more CNG per volume at lower pressures in form fitting tanks. $QTWW is working w/ BASF using "MOF" on this next step in the revolution beyond pressurized cylinders.

    As for competitors, major players such as 3M (which you mention) and Luxfer (which you didn’t) traditional buy out smaller competition to secure IP and key customer relations. It shouldn’t be a surprise to anyone to see $QTWW get purchased once it has divested the wind biz.
    Nov 26 03:11 PM | 3 Likes Like |Link to Comment
  • BofA note spooks Amgen, Ligand investors [View news story]
    Of course Celgene (who has a pair of ther own dogs in the MM hunt) will suggest a competitor product should be used with caution. What I find amazing it that this one note resulted in a 12% swoon in the price of $LGND stock. Sure, they get Kyprolis royalties and sell them captisol, but the royalties are rather small as a % of Kyprolis sales and they still sell captisol to a wide array of customers.

    Cowen, Roth and now Summer Street are all out defending, which is why $LGND has regained 100% of what they lost.
    Nov 22 10:09 AM | Likes Like |Link to Comment
  • Cummins' New 12-Liter Natural Gas Engine Is A Game Changer For Clean Energy [View article]
    Nice article, though expecting a 25% pop in $CMI based off this engine alone is rather aspirational.

    If you want a huge pop off this news and the trend in general, consider that much of the incremental dollars in the NGV market is actually in the fuel tank and injectors. With the engines, $CMI is selling a new NG engine, but mostly at the expense of not selling a desiel engine. And now some of the profit flows to $WPRT from these new engines. So its not pure gray if you know what I mean. And then there is a booming biz in desl to CNG/LNG conversions.

    The most expensive part of these conversions or incremental parts on a NVG OEM is the tank. And there are many tank options, but as short haul and industrials go CNG (rather than LNG to avoid cyrogenic loss) many are selecting the type IV tanks (ligher and can carry more fuel).

    The name I've been invested in here is the turn around story of a small SoCal company called Quantum Fuel Systems. ($QTWW) They had a near death experience last year as they were also the EV engine producer of the Fisker Karma. When A123 went B/K, Fisker couldn't get batteries and as it was already on the ropes, it went B/K too. Nearly killed $QTWW who also had all sorts of ill advised investments such as in wind farms. But all that and the old management team is gone, and now it is all about back to their roots and Type 4 CNG tanks.

    The stock has started to come back strong of late, except for a quick pullback after some fundraising. But the company recently was awarded a teir 1 supplier agreement with GM for type iv tanks for the new Impala bifuel (think taxi and fleets). And they are already doing tank work for $CMI and others truck OEM producers, as well as retrofitters like http://www.zheo.com.
    Nov 6 04:23 PM | Likes Like |Link to Comment
COMMENTS STATS
110 Comments
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