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VirnetX Holding Corp Message Board

duckduffer 75 posts  |  Last Activity: 15 hours ago Member since: May 29, 2003
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  • duckduffer by duckduffer 15 hours ago Flag

    Wasn't much discussion about it, but 11 days ago final institutional holdings for the quarter ending 3/31 were in. EXEL was back up to 77% institutional ownership, with over 176M shares held by 172 institutions. The largest holder, Fidelity with 34M shares. At that time, 3/31, the PPS was $4. Assuming the majority of those holders are still long, they are up 57% from that date. Not a bad place to have your money parked. Even the Baker Brothers had opened a position of 2.5M shares. No guarantees everyone sticks around, but encouraging to see such a high percentage of ownership.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    So here's our Analyst coverage (so far!)

    by captainhymanshocker May 23, 2016 12:16 PM
    duckduffer duckduffer May 24, 2016 9:37 PM Flag

    " The rational thing to do reading their press releases is to assume they are they are painting the best picture possible."
    Sage advice and definitely a good approach. I suppose my take is merely that the METEOR OS data that wasn't disclosed in the early PR's was speculated as being problematic for Cabo RCC sales (and AF wrote an article calling this out). They could have easily released the data and prevented the negative spin, so I'm not sold on EXEL PR's consistently painting of the best picture possible. On that occasion, they did not.

    Sentiment: Strong Buy

  • Reply to

    So here's our Analyst coverage (so far!)

    by captainhymanshocker May 23, 2016 12:16 PM
    duckduffer duckduffer May 24, 2016 8:30 PM Flag

    "Has me thinking that maybe CABOSUN exceeded their expectations"
    There's been significant prior speculation that the EXEL clinical strategy moving forward was only for trials related to anti PD-1/PD-L1 combinations, basically rendering all the other IST clinical trials for informational purpose only. This CABOSUN data, however, may be compelling enough to have caused a reevaluation of strategy. And to your point, combine it with Levantinib approval, it can really stir things up. I don't share the opinion that EXEL has a history of over selling their data. I would suggest the opposite. Take the METEOR OS data for example. Everyone with an opinion (AF) disclosed their fears that EXEL was hiding less than inspiring results and therefore hadn't published the full data set. They couldn't have been more wrong. The best OS HR yet seen in RCC therapy.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer May 24, 2016 4:04 PM Flag

    Cabosun was not a smaller trial from a data perspective. There were more patients in each arm of the study than the L&E study (50 patients per arm).
    "With 123 events (disease progression or death), the log-rank statistic has 85 percent power (with a one-sided type I error rate=0.12) to detect a hazard ratio of 0.67. Between July 9, 2013 and April 6, 2015, 157 patients were randomized: 79 patients on the cabozantinib arm and 78 patients on the sunitinib arm"

    Why would Toni Choueiri say"cabozantinib may have the potential to become a new gold standard" if the data wasn't good enough for a 1st line submission? That is an incredibly strong statement.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    So here's our Analyst coverage (so far!)

    by captainhymanshocker May 23, 2016 12:16 PM
    duckduffer duckduffer May 24, 2016 1:01 PM Flag

    Should we take a little focus off the daily tape for a while? And think more about where EXEL is going, to what valuation after this latest news? If you accept the estimates that the RCC drugs market will be over $4B by 2020, and an assumption of that Cabo would have to be at least 25%, what does it mean? The RCC drugs revenue baseline in 2013 was $2.6B, so let's say it's close to $3B today. With the RCC market and Cabo ramping up over the next 4 years, is it safe to say Cabo will achieve a PAR of $1B? With MTC and Cotellic revenues (which could also be significant with a Roche CRC combo), where is fair value today? Up until even yesterday, RCC sales were discounted with a significant risk factor (what if Cabosun had not been positive?). Going forward, my SWAG valuation, until such time that either quarterly sales prove out further value or HCC topline reads out positive, is $3B. At todays $1.41B valuation, we have some runway left. Should be a fun summer.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Does anyone believe PFE is just gonna say

    by enabeler May 24, 2016 9:44 AM
    duckduffer duckduffer May 24, 2016 12:36 PM Flag

    True, but they then lose the benefit of the gains on the bond conversion. IE, if the price of the common goes to $8, that is a 30% increase from today. A short holder with a convertible bond as an arb play will lose that entire benefit as they have to use their convert to cover the short position.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer May 23, 2016 8:18 PM Flag

    You could make an argument that the Comet failure wasn't due to the indication, but due to the trial design. As wildbiftek recapped in Feb of 2015, "For 191 pts with visceral disease median OS was 7.1 months for Cabo vs 4.8 months for Pred (HR 0.65; P = 0.0215). " Had this been the target population, perhaps we get a much different outcome.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer May 21, 2016 2:55 PM Flag

    So...we now know why MMM threw that tell out during the Bank of America Investor presentation... Each year in the U.S., 147,000 new cases of CRC are diagnosed and more than 57,000 people die from the disease—making it the second leading cause of cancer-related deaths in this country.

    Sentiment: Strong Buy

  • Reply to

    comparing Cabozantinib and Lenvatinib

    by biotechblood May 14, 2016 6:45 AM
    duckduffer duckduffer May 15, 2016 6:58 PM Flag

    Ernie,
    Any thoughts on the EMA following suit with an Lenva/Ever approval in RCC? Are they any different in how they historically view approval off a compelling set of Phase 2 data? And why do you think the NCCN voted the combo down, considering your early view that the data was strong enough for a possible approval? What did the KOL's from the NCCN not understand?
    GLTA

    Sentiment: Strong Buy

  • Reply to

    lenvatinib/everolimus combo approved

    by rad.onco May 13, 2016 5:05 PM
    duckduffer duckduffer May 14, 2016 1:04 PM Flag

    This Michael Schmidt comment from the Leerink upgrade aligns with what Ernie, Wilder and others are posting regarding it's impact on Cabo.
    "We believe the pending PDUFA date for Eisai's lenvatinib (multi-TKI) in 2L RCC on Monday, May 16, has created an overhang on the stock. Based on our due diligence highlighted here, we believe that (1) the approval probability of lenvatinib is very low, despite breakthrough therapy designation (BTD), and (2) if approved, we don't think lenvatinib would compete with Cabo."
    It will be interesting to see if any follow up commentary comes out next week.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    lenvatinib/everolimus combo approved

    by rad.onco May 13, 2016 5:05 PM
    duckduffer duckduffer May 13, 2016 7:20 PM Flag

    Would that indicate the combo would not be approved for use in 3rd line....after 2nd line Nivo? A place we have all assumed Cabo would be designated by many Oncs anyway?

    Sentiment: Strong Buy

  • Reply to

    lenvatinib/everolimus combo approved

    by rad.onco May 13, 2016 5:05 PM
    duckduffer duckduffer May 13, 2016 6:30 PM Flag

    Leerink mentioned this event having been an overhang on EXEL's PPS. Well it is no longer an unknown, the debates can begin on clinical uptake. And to your point, the lack of data combined with cost and toxicity may push the Lenv combo to the back of the bus.
    There is also the poster (4557) being presented at ASCO discussing Cabo's efficacy following Nivo. Data from the subgroup analysis. For patients who had received prior PD-1/PD-L1 therapy, the median PFS for cabozantinib was not reached, and the median PFS for everolimus was 4.1 months (HR = 0.22, 95% CI 0.07-0.65).

    Sentiment: Strong Buy

  • Reply to

    lenvatinib/everolimus combo approved

    by rad.onco May 13, 2016 5:05 PM
    duckduffer duckduffer May 13, 2016 6:02 PM Flag

    Phase 2 vs Phase 3 A/E comparison-

    The most common serious AEs with the Phase 2 lenv/ever combination were renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), vomiting (5%), and dyspnea (5%). AEs led to a dose reduction or interruption for 89% of patients in the combination arm versus 54% with single-agent everolimus.

    The most common serious AEs in the Phase 3 cabozantinib arm were abdominal pain (3%), pleural effusion (3%), and diarrhea (2%). Dose reductions were required for 60% and 25% of patients, in the cabozantinib and everolimus arms, respectively.

    Time will tell how the Oncs view the data, seems like cost and toxicity are always important. The OS HR's were almost identical, with Cabo having a slight advantage at .66 versus the Lenv/Ever .67.

    Sentiment: Strong Buy

  • Reply to

    PDUFA date Eisai's lenvatinib Monday 16th

    by translationhell May 13, 2016 2:41 PM
    duckduffer duckduffer May 13, 2016 5:04 PM Flag

    FDA Approves Eisai's LENVIMA® (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma in Combination with Everolimus Following Prior Anti-Angiogenic Therapy.
    Wow. Good numbers but a near unanimous decision from the NCCN to get more data and the FDA says...what the heck.

    Sentiment: Strong Buy

  • Reply to

    Except for a Black Swan event..

    by captainhymanshocker May 13, 2016 3:02 PM
    duckduffer duckduffer May 13, 2016 3:40 PM Flag

    NCCN Guidelines for Kidney Cancer V.2.2016 – Web Conference – 11/09/15
    Based on discussion and the noted reference, the panel consensus was to not include lenvatinib in combination with everolimus as a treatment option for subsequent therapy for relapse or for surgically
    unresectable Stage IV disease with predominant clear cell histology due to limited data.

    It would be a true shocker if the FDA didn't agree with the 12-1 vote of the NCCN regarding Lenvatinib on Monday. The panel wants a Phase 3 and most likely the FDA will agree.

    GLTA

    Sentiment: Strong Buy

  • Reply to

    Axing

    by snowflakeformationxy May 13, 2016 3:14 PM
    duckduffer duckduffer May 13, 2016 3:24 PM Flag

    Snow,
    I'm always interested in your posts. You have a unique insight here that not many possess. Thank you for sharing. Even those times when it's not what we want to hear.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Cash and the Debt

    by duckduffer May 13, 2016 11:55 AM
    duckduffer duckduffer May 13, 2016 12:09 PM Flag

    OK, assuming sales accelerates and doesn't stay static at 100 new scripts per month (that was just to get a 9 month perspective), with an eligible patient pool of 17,000 annually in the US, might we assume the rate grows to 30% of the eligible patients in 2017? This would spin off 37,740 billable months (7.4 months per patient) of scrips at an adjusted $10K per scrip, or $377M. By the end of 2017, EXEL's cash- 2016 YE= $384M + $377M +$60M (MTC/Cobi) - $240M expense= $581M.
    Current debt is below $581M. Pretty good cash to debt ratio.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer May 13, 2016 11:55 AM Flag

    Senner's comment-
    "With the cash we had to start the year, disciplined expense management, including the costs associated with launching Cabometyx in the U.S. for advanced RCC, and the anticipated milestones from Ipsen, we are projecting that we'll be in a very healthy cash position at year end."

    So what is the back of the napkin math on year end cash? Cash was $407M at the end of March. Expense is estimated between $60-67.5M per quarter, with up to $7.5M of that non cash. So lets use $60M x 3 quarters= $180M in cash expense. European approval of Cabo nets EXEL another $60M from Ipsen, this will occur before year end. The big question is how much uptake will occur between now and then? If they have written 300 scrips thru the earnings call, with volume accelerating, could we safely assume another 100 scrips per month? With 8 months remaining in 2016, at 100 new scrips per month, EXEL could have accrued roughly 6000 billable scrip months by year end (and over 1000 per month by November). At an adjusted $10K per scrip, that would mean $60M in RCC revenues. Add in MTC ($25M) and Cobi ($12M), EXEL generates almost $100M in sales between now and year end.
    Cash-$407M + $60M
    Expense-$180M
    Revenues-$97M
    Year end cash- $384M
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Bank of America presentation remark

    by hbomb57108 May 10, 2016 5:55 PM
    duckduffer duckduffer May 10, 2016 6:28 PM Flag

    And perhaps another tell is revealed....he covers nicely with remarks around how the science should work, but you're right, he sounded like he knows a bit more than he is letting on.....ASCO may turn out to be a very solid catalyst this year

    Sentiment: Strong Buy

  • Reply to

    CABOSUN

    by rad.onco May 9, 2016 3:01 PM
    duckduffer duckduffer May 9, 2016 3:47 PM Flag

    CABOSUN is being conducted by The Alliance as part of Exelixis’ collaboration with the NCI-CTEP. Thus, Exelixis will not be announcing the data. But given the historical PFS duration for sunitinib in similar patients in the first-line setting (11 months) and that the trial was fully enrolled in May of 2015, results could be any day. Gisela has commented that results should be in the first half of 2016.
    GLTA

    Sentiment: Strong Buy

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