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VirnetX Holding Corp Message Board

duckduffer 48 posts  |  Last Activity: Sep 19, 2014 4:59 PM Member since: May 29, 2003
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  • duckduffer by duckduffer Sep 2, 2014 7:30 PM Flag

    Warren Buffet's sage advice would be buy when everyone is selling. Not an easy thing to do when a stock gets pummeled by 55% due to missing trial endpoints less than 6 months after getting pummeled by 45% for missing that same trial's interim analysis. This stock is down 75% from its high in March...despite a big win occurring in July when EXEL partner Roche announced compound Cobimetinib had met trial endpoints. Cobi is a drug that has conservative estimates of $150M in peak annual sales to EXEL. The stock is down 75% despite having rapidly improving sales (over 50% growth in Q2) in MTC with Cabozantinib, an indication that has estimates of $60M in annual sales. That alone accounts for a low risk peak annual sales estimate of over $200M. Most bio's would value at 5X that amount which is $1B. And that amount does not include anything for potential revenue opportunities in Phase 3 trials for RCC and HCC. Or for revenue opportunities in BRAF+NSSLC. Yet here EXEL sits today at $360M.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    70% layoff ...

    by godhairyballs Sep 3, 2014 6:16 PM
    duckduffer duckduffer Sep 3, 2014 8:10 PM Flag

    "Expect about $2.8 or ~$750M (cap+debt)"....

    I would suggest the following regarding a buyout.

    1)The release of excellent CoBrim data will be a big boost for the PPS. The cash flow from a standard of care drug for BRAFV600 MM could begin by mid 2015. That would have huge implications on cash needs. In addition, the downsizing of the company and the halting of all CRPC related trial expenses will also have significant impact on cash needs. The big concerns about cash may be considerably dampened by the time they actually need to raise some (after METEOR reads out). Which leads me to....

    2) Highly unlikely they sell the company before RCC reads out. This is the indication that clearly has the lowest hurdle to clear from an FDA approval standpoint. The value of EXEL with MTC, Cobi, and RCC is significantly greater than $2.80 PPS. All three of those indications could be producing a significant amount of revenue and cash ($400-500M PAR) before the majority of EXEL's debt (the convertibles) are due in 2019. Why would EXEL accelerate those terms if they still have line of site to going it alone?

    The story is far from being over for EXEL. If Roche (or anyone else) came up with a $2B offer, perhaps the BOD would hit the sell button. But despite a Comet 1 failure, there is still way too much opportunity here to sell for peanuts.

    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Sep 15, 2014 1:24 PM Flag

    For those watching the ticker on EXEL minute by minute, let me suggest one thought. With revenues that are in the tens of millions and expenses that are in the hundreds of millions due to clinical trials, this is a playground for shortsellers. The financial uncertainty is what allows them to do FUD gymnastics. In addition, there are still convertible holders who have an arbitrage play that continues to go short, cover, buy long, sell, sell short....etc. This will also continue until such time as a meaningful binary event produces true market optimism for EXEL's long term prospects. The CoBRIM topline data at ESMO may be one of those events. Certainly Comet 2 topline and Meteor RCC topline are those types of events. But in the interim, if you wish to live longer, perhaps a slightly less reactive view towards the daily PPS would help.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Sep 16, 2014 9:01 PM Flag

    enabler,
    The investment thesis on EXEL has been discussed here ad nauseam by regular posters. Multiple shots on goal. MTC, COBI, CRPC, RCC, HCC, NSCLC, etc. The first missed goal, CRPC, was unfortunately the least likely to score. Many, many regular posters here speculated on a fairly low likelihood of success. Many blogs like Ohad Hammers, which many posters regularly referred too, had the chances of success at 30%. The most optimistic post I can recall from an informed poster was no more than 60% chance of success. Better than 30%, but a long way from a sure thing. CRPC was a long shot. As MMM said many times, the data was "provocative". Provocative means suggestive, but not definite. The facts are that Cabo performed as expected. The control group did not. Many physicians and biotech analysts will tell you that Cabo has good activity in CRPC. But at the end of the day, EXEL needs to score their other shots on goal. That's how it works. All the FUD being thrown around isn't going to change the investment thesis. If CoBRIM data is good, Cobi/Zelboraff become the standard of care in BRAFV600 melanoma. That is a significant shot on goal. We'll see how it goes from there. Don't lose your perspective or you walk right into the FUDsters fog emporium.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    5 full months past interim analysis announcement

    by wildbiftek Aug 26, 2014 4:49 PM
    duckduffer duckduffer Aug 26, 2014 8:53 PM Flag

    Socialidiocies,
    You may or may not be aware but you aren't making any sense. Statements from your posts are either inaccurate or not possible. As an example-"I don't know, they could have enrolled the last 1/3 of patients in the third quarter of 2014, which means we will not have the data"
    Read the clinical trial updates for Comet 1 and you will find out the trial was fully enrolled in Sept. '13. We are currently in the 3rd quarter of 2014, so enrolling patients is null as the trial has been fully enrolled for almost a year.
    Do the math on the length of time since the enrollment was completed, 11 months. While we don't know the exact enrollment for each month, we do know it was fully enrolled 11 months ago. That is longer than the estimated mean survival for the control group of these very sick patients re the design of the trial. Suggesting the trial could go to June of 2015 is a massive stretch. If the treatment was that effective, it likely would have shown up in the interim results.
    Think about it, 387 events triggered the interim in March. Even if we assume they enrolled a large percentage in the last couple of quarters before Sept. '13, we could still safely assume 70% enrollment occurred by June'13, or 672 patients. And we can also assume the 387 events triggering the interim would come from that group. We can then assume that at least 285 of the remaining sick patients would now have been either on placebo or treatment for 13 months minimum and most longer than that. It seems nearly impossible that out of those 285 patients on either treatment or placebo for a minimum of 13 months, that there wouldn't have been 191 more events. This trial is salvage therapy, with a very very sick group of patients who have exhausted the treatment regime. I hope for the patients sake and for the sake of future Cabo patients, that this assumption is wrong. But it is what the trial is expecting.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Morgan Stanley Transcript

    by duckduffer Sep 9, 2014 7:07 PM
    duckduffer duckduffer Sep 10, 2014 12:05 PM Flag

    Thanks for the read Wilder. There's a statement in the article that addresses the possibility of drug approvals in mCRPC for PFS, despite other approved compounds having been granted based on OS. I would bet that after the Comet 2 topline data, anticipating good pain palliation and a positive OS trend, there will be much more discussion regarding this possibility. And deservedly so. It would be a crime not to allow physicians to utilize a compound that has proven efficacy on bone mets, pain, and soft tissue. OS will improve as better sequencing and biomarker understanding evolves. But in the near term, how about just putting patients in salvation therapy on Cabo for an initial 6 week interval. If bone scans improve, CTC levels decline, and pain palliation occurs...continue therapy...the data suggests you will live longer and with a better QOL. Seems almost too simple...:)
    GLTA

    Sentiment: Strong Buy

  • Here is what we know. Cabo in RCC demonstrated a 14.7 month PFS in a Phase 1b study that included heavily pretreated patients (88% having received prior anti-VEGF therapy, 60% having received prior mTOR inhibitor therapy, and 52% having received ≥1 anti-VEGF and 1 mTOR therapy). While that is based on a single arm small sample size study, the results are compelling. Not only is the PFS quite good, the efficacy with patients who are refractory to other treatments is very significant. Let hope the statements made by MM, and Debra Burke relating to having sufficient cash until after the RCC topline readout is solid. If Meteor delivers these type of results combined with what could be very compelling data from CoBrim.....to the moon Alice. For the record, these indications were the primary reason why holding through Comet 1 readout wasn't as big a gamble as many have indicated. The gamble was on hitting a major out of the park homerun in the shorter term. But as for EXEL and still seeing a good return on investment, Meteor and CoBrim have been the hole card all along.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    News at 6AM tomorrow would not surprise me

    by roger5147 Jul 24, 2014 6:23 PM
    duckduffer duckduffer Jul 24, 2014 8:48 PM Flag

    Cowen's Dr. Eric Schmidt-

    Dr. Schmidt: We think the COMET-1 trial has a better than 50% chance of success. This based upon favorable Phase II data across a variety of metrics including prolonged PFS, bone scan resolution, pain reductions, and CTC count lowering.

    Sentiment: Strong Buy

  • Reply to

    Timeline misconceptions

    by socialidiocies Aug 27, 2014 1:23 PM
    duckduffer duckduffer Aug 27, 2014 1:35 PM Flag

    Social- You've descended into just pure babbling. Sorry but it's time to put you on ignore as you have nothing to add to the conversation that I need to evaluate.

    Sentiment: Strong Buy

  • duckduffer by duckduffer Sep 12, 2014 5:06 PM Flag

    Very telling exchange from the Morgan Stanley conf-

    Unidentified Analyst

    "And in light of the recent news, have you looked at changing your call-through relationship with Roche as a potential way to perhaps increase your cash balance?"

    Michael Morrissey - President and Chief Executive Officer
    "We like our current collaboration with Roche and the framework for that. We think the asset has a lot of value now and could have more value going forward if the other trials that are ongoing are successful and lead to additional pivotal trials of the other combination. So, we are not looking at ways of monetizing that asset right now to be able to increase our cash position now."

    So for all those critical thinkers spewing FUD about BK as a near term possibility.... EXEL has a number of options for monetizing assets that would bypass seeking funds from the capital markets. EXEL has been fairly consistent in expressing they have the cash to operate through the Meteor topline readout...and with those results in hand...what would the monetization opportunity be for partnering Cabo outside the US?? It's certainly a number in the hundreds of millions considering MTC and RCC revenue opportunities. A monetization could occur within days of RCC topline results. Cobi has the same oppty for monetization, but as MMM clearly indicates, they project even more value with additional trials. We shall see what direction EXEL chooses. For today raising cash isn't a concern, but when it is there will likely be excellent options outside of capital markets.

    Sentiment: Strong Buy

  • Reply to

    RCC PFS Approvable Endpoint

    by duckduffer Sep 5, 2014 1:14 PM
    duckduffer duckduffer Sep 5, 2014 5:11 PM Flag

    There are key differences Clem. In CRPC with Cabo there was no OS data prior to Comet 1/2 trial design/launch (May'12). It wasn't until well after the launch that OS data from the RDT NRE cohort readout (June'13). The OS from the NRE was 10.8 months which is almost identical to the Comet 1 results of 11.0 months. Also from the NRE was data that suggested patients showing bone scan response at week 6 and pain reduction from Cabo therapy had a direct correlation to increased OS times. Perhaps with that information in hand and available for consideration/feedback from the FDA, the Comet/s could have been better designed prior to launch. Of lesser significance, but also potentially problematic, OS is susceptible to the confounding impact of subsequent therapies after disease progression.

    On the other hand, in RCC the data for PFS was in hand when they designed the trial. I don't know if the small sample size is going to be perfect as it relates to trial design, but at the end of the day, the data was there and the trial was based on that real data. PFS is also much less likely to confounding factors in the data as there is no "subsequent therapy". Once the disease progresses, the data is locked.

    You have to admit those are pretty significant differences between the trials and IMO their prospects for success.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Sep 1, 2014 11:18 PM Flag

    Should be somewhat enlightening as to the short term priorities. Clearly the company still has big opportunities with RCC, HCC, NSSLC and of course, Cobimetinib. The Hammer blog has been 100% correct so far and Omar suggested the value of EXEL to be in the 5's despite his prediction of a Comet 1 failure. I would suggest you read the blog prior to selling. Omar has an excellent track record and his estimates for the future of EXEL are much brighter than the mood on this message board this evening. While we don't have the detail of the CoBrim results, we know they achieved the trial endpoints. If they are as good as the Phase 2 results, EXEL's profit share partnership could be in the $500-1B dollar valuation range. Just food for thought.
    GLTA

    Sentiment: Strong Buy

  • Here is a statement by MMM that resonates-
    "The PFS endpoint was an exploratory endpoint and it was investigator-generated, but that was significantly favoring cabozantinib. We had a hazard ratio there of 0.5. So, that’s the second trial now where we have seen a pretty dramatic PFS benefits for cabozantinib first in the MTC trial EXAM where we saw a hazard ratio of 0.28 and now in the second trial COMET-1 where we saw hazard ratio of 0.5 for PFS, so somewhat interesting connection there between those two trials. Again, the METEOR trial is looking at PFS as the primary endpoint for RCC. So, that’s actually I think a very good point to kind of underscore"
    GLTA

    Sentiment: Strong Buy

  • Reply to

    realize comet 1 failed but is it totally over

    by alsodoglover Sep 18, 2014 5:48 PM
    duckduffer duckduffer Sep 18, 2014 8:54 PM Flag

    " I truly believe that we have not seen the last of Cabo and prostate cancer.....". Certainly a possibility. There is an interesting take from the ORF blog (Ohad Hammer) on personalized medicine and NGS-based (next gen sequencing) products for tumor profiling. He mentions EXEL as a company who may utilize these products in the future. The article is on Foundation Medicine. He states "personalized medicine is becoming a reality in oncology and many drugs will require patient selection on a molecular level". What impact would this testing have had if used on the RDT Phase 2 CRPC patients? Perhaps a significantly more specific patient profile in Comet 1.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Bad news coming for Comet-1

    by biorunnerzz Jul 17, 2014 3:24 PM
    duckduffer duckduffer Jul 17, 2014 4:19 PM Flag

    It's a shame you have to read the first email from a mouth breather like this guy before you can put them on ignore.

    Sentiment: Strong Buy

  • duckduffer by duckduffer Aug 1, 2014 11:34 AM Flag

    I don't think anything is ever in stone when it comes to raising cash, but here is the most compelling statement in the CC from my perspective. It's from Debbie Burke-
    "We continue to expect total cost and expenses in the range of $250 million to $280 million and we anticipate to end the year with greater than $200 million in cash. Our outlook for the length of our financial runway also has not changed and we continue to be confident that our runway extends through the readout of METEOR trial for RCC."
    IMO this is a declaration that the plan is to not raise equity until after RCC topline data which should be early 2015. That would explain the $80M fundraising they did in March. I'm optimistic about COMET, but let's face it, the single most likely trial to show overwhelmingly positive data is METEOR. I like the plan. Let's hope they stick to it.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Phase 3 Victory....melanoma

    by gabrjelac Sep 3, 2014 8:22 AM
    duckduffer duckduffer Sep 3, 2014 11:53 AM Flag

    CoBrim results should be very compelling. Might see a 100% or greater pop in the PPS when it's confirmed that Cobi/Zelboraf combo will be the standard of care in BRAFV600 MM. What makes this story even more compelling at these levels is that Cobi is in another 5 clinical trials with Roche, initiated in the last year. Roche has shown a big interest in this EXEL developed MEK inhibitor. This is from a Roche PR- "In addition to the combination with Zelboraf in melanoma, cobimetinib is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumour types, including non-small cell lung cancer and colorectal cancer."
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Aug 12, 2014 11:23 AM Flag

    We are 3 days away from getting all the updated institutional ownership numbers from end of June. So far there isn't much too report, but it appears Wellington CM may have lightened up significantly. If one was to interpret their SC13G/A filing as saying they own 12M shares currently, that's about 8M fewer than they held at last report. It would also appear they sold on July 15th, one of two huge volume days (38M & 16M shares) following the Cobi announcement and speculation of a Roche takeout. So if your wondering why the Cobi rally fizzled......To further expand on the selling pressure that has been present since then, during that same period July 15-July31 shorts piled on with another 3+M shares sold short. Now we know why there has been selling pressure despite excellent news regarding Cobi meeting its trial endpoints.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    RCC PFS Approvable Endpoint

    by duckduffer Sep 5, 2014 1:14 PM
    duckduffer duckduffer Sep 5, 2014 2:55 PM Flag

    As pointed out by wildbiftek, the confounding concerns are less regarding the control arm with PFS. And if you were to draw comparisons to the Comet trial, you would note that PFS was also quite good and stat sig.

    Sentiment: Strong Buy

  • Reply to

    One nasty black candle this morning

    by milkman92714 Jun 23, 2014 10:53 AM
    duckduffer duckduffer Jun 24, 2014 3:21 PM Flag

    Wilder,
    Consider if you will that as recently as Jan. 23rd the PPS closed over $8....and that the decline since was due to a combination of biotech selloff and Comet 1 interim analysis bear raid. If any of the coming key data points (Exam OS, Comet 1, or CoBrim) come out positive first, it would make sense that we would quickly revisit that $8 PPS. My SWAG is that with more than one positive event, we move to a $2.5B valuation rather quickly ($12.50 PPS) and with all 3 positive a 2014 end of year $4B valuation ($20 PPS) is in play. If you don't believe that scenario just look at the valuation of MDVN or the buyout of Algeta after positive Phase 3 data for CRPC...and with compounds that were 50% partnered (Enzalutamide and Alpharadin). The best news is that all the data leading up to now would suggest that scenario appears more likely than not. Anyone selling at current levels has to seriously need the cash. These catalysts could literally happen any day.
    GLTA

    Sentiment: Strong Buy

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