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VirnetX Holding Corp Message Board

duckduffer 56 posts  |  Last Activity: Dec 15, 2014 6:51 PM Member since: May 29, 2003
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  • Reply to

    From the Roche news release

    by enabeler Dec 15, 2014 7:56 AM
    duckduffer duckduffer Dec 15, 2014 6:51 PM Flag

    Another thing to consider in your $300M sales projection for Cobi combo, besides use in other indications, is the length of time patients will be on the drug. Since PFS is 50% longer on the Combo, than on Zelboraf alone, it would imply an increase in usage overall of 50% just due to time on medication. Perhaps a $400M+ projection, based on duration of treatment alone?

    Sentiment: Strong Buy

  • Reply to

    From the Roche news release

    by enabeler Dec 15, 2014 7:56 AM
    duckduffer duckduffer Dec 15, 2014 1:48 PM Flag

    I'm wondering if the next significant news item will be regarding priority review. They received a Fast Track designation for Cobi so you would have to believe they are requesting a Priority Review with this NDA. If so, it would come within the next 60 days. If issued, it would guarantee a 6 month or less action on the NDA vs the standard of 10 months.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Look for end of year PR about coBRIM filing

    by patriot901 Dec 12, 2014 11:16 AM
    duckduffer duckduffer Dec 12, 2014 3:56 PM Flag

    " The FDA already knows this is coming and the results from trials were very positive".
    Easiest decision they will ever make. Cobimetinib plus Zelboraf reduced the risk of disease worsening by half ( median PFS 9.9 months vs 6.2) compared to Zelboraf alone. The IRC had even better numbers, with CobiZ median PFS of 11.1 months vs. 6.0 for Zel alone. This will not only fly through the FDA Fasttrak approval process, it will be adopted by healthcare professionals even faster. Why would you even consider using Zelboraf alone?

    Sentiment: Strong Buy

  • Reply to

    Comet-1 vs. Meteor

    by ulingt Dec 9, 2014 8:29 PM
    duckduffer duckduffer Dec 10, 2014 12:58 PM Flag

    MM made these comments during the Stifel CC in November. At around 14:30 into the call he said-
    "Both VEGF and MET play a part in RCC. This was the initial rational for combining these two inhibitory activities into a single molecule.....we used the RCC tumor biology to base our initial hypothesis for the design of molecules like Cabozantinib"
    I'm paraphrasing slightly but you can go back to the conf and listen for yourself.
    As for the logic behind why/if PFS improvement in Comet 1 is significant relating to Meteor, it probably isn't. Two different types of cancer. But many have suggested that Comet 1 was a negative indicator for Meteor, which couldn't be further from the truth.
    For a better indicator of what might happen in Meteor look at the Phase 1b trial data. Small trial, but in a cohort of heavily pretreated patients, PFS was 14.7 months. Compare that to the primary endpoint for Meteor of 7.5 months PFS. Small studies for obvious reasons don't always demonstrate consistent results with larger studies. But if the Phase 3 trial was a sure thing....the PPS wouldn't be where it is :)
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 7:49 PM Flag

    Also, I referenced liver cancer. I meant RCC, which is kidney cancer. Long day. Cabo was designed to treat kidney cancer.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 7:14 PM Flag

    "can you explain the difference between ' PFS topline and stat sig positive PFS'?"
    Sorry, that was a bit of a hurried post. PFS is the primary endpoint in Meteor. It means if they achieve the topline results for the primary endpoint, it would suggest they would be able to get FDA approval. PFS was not a primary endpoint in the Comet 1 trial, however, it was an exploratory endpoint. And in the exploratory endpoint of PFS for Comet 1 the data was stat sig or statistically significant. Since PFS is not an approvable endpoint in mCRPC, it didn't matter that PFS had a statistically significant improvement over the comparison arm.
    "how is it determined where to set the bar?"
    The bar is based on demonstrating a statistically significant improvement over the comparison arm of the trial. In Comet 1 it was the prednisone arm. In Meteor it is the everolimus/afinitor arm.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 2:23 PM Flag

    Last post was cutoff. The PFS from Comet 1 was a 50% improvement over the prednisone arm (5.8 mo vs 2.8 mo). The primary endpoint for Meteor is also a 50% improvement. This data from Comet 1 thus supports a successful Meteor. Quite the opposite from what many bears are posting.
    Beyond the Comet data, the development of Cabo was based on the theory that inhibiting both VEGFR and MET might be key in successfully treating liver cancer (per MMM on the last CC). Cabo, while active in many cancer types, was specifically designed for liver cancer. Logic dictates with a PFS endpoint in and indication the drug was designed to treat the odds are much more favorable for success in Meteor.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 12:59 PM Flag

    Some are projecting a fail in Meteor due to the Comet topline. Not logical. Meteor has a PFS topline. Cabozantinib had stat sig positive PFS in the Comet 1 trial. Median PFS was 5.5 months for the cabozantinib arm of the trial versus 2.8 months for the prednisone arm (hazard ratio 0.50; 95% confidence interval 0.42 – 0.60; p value

    Sentiment: Strong Buy

  • Reply to

    wilder, ernie, duckduffer, etc.

    by enabeler Dec 2, 2014 2:41 PM
    duckduffer duckduffer Dec 3, 2014 8:13 PM Flag

    They had $293M in cash at the end of Q3. You might be a little off on your prediction.

    Sentiment: Strong Buy

  • duckduffer by duckduffer Dec 2, 2014 10:54 PM Flag

    "Once all data from COMET-1 and COMET-2 are available we will formulate our regulatory strategy for CRPC if any"
    This was on the earnings call in early November and was the first time they used the "if any" qualifier. I think Gisela said it a couple of times on the last CC. Was I dreaming or on Sept. 2 did EXEL halt Comet 2 after Comet 1 topline and deprioritize clinical development of Cabo in CRPC? Positive Comet 2 would have been a nice feel good moment or two...but would have meant very little in terms of EXEL's prospects. They know this. Hence the "if any". The future is still RCC, still HCC, still NSCLC, still Cobi, possibly XL888...who knows what else. But it wasn't expected to be CRPC. Not lately.

    Sentiment: Strong Buy

  • Reply to

    wilder, ernie, duckduffer, etc.

    by enabeler Dec 2, 2014 2:41 PM
    duckduffer duckduffer Dec 2, 2014 9:55 PM Flag

    enabler,
    I have yet to get caught up on the board since last weekend and haven't listened to todays CC, so I'm not sure I have anything new from what might be posted already. The PPS impact is overblown, but with 50M shorts what should we expect? Anything that can be spun as catastrophic will be by those with a financial interest. I don't recall anyone, on this board or even analysts putting any valuation on the Comet 2 outcome without a successful Comet 1. So what has changed? The PPS is an even better deal today than last week if you believe that a positive PFS outcome in RCC is a highly likely.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    235,000 shares at 1.66 what's up?

    by drummer1517 Nov 28, 2014 1:53 PM
    duckduffer duckduffer Nov 29, 2014 5:59 PM Flag

    It means Friday was the last day to sell and be able to conform with the wash sale rule of 30 days and buy back in before 2015. Doesn't mean anything going forward. Did you really believe it might?

    Sentiment: Strong Buy

  • duckduffer duckduffer Nov 24, 2014 7:46 PM Flag

    Another point relating to the cash burn rate.. per the CEO MMM and the CFO Debra Burke, EXEL has enough cash runway to get through the end of 2015. One thing we know about EXEL's cash is that $80M is restricted. So in order to see the projected burn rate, use the math provided by EXEL's CFO. Current cash- $293M less ($80M) restricted= $213M divided by 5 (number of quarters until end of 2015)= $42.6M per quarter if they spent every dollar. Then factor in MTC revenue, per the CC they are utilizing current revenue rates for MTC in the calculation. That adds another $6.3M per quarter. So we know that the CFO anticipates no more than an average burn of $48.9M gross = $42.6M net for the next 5 quarters. Assume the obvious, clinical trials winding down, burn rate declines every quarter. What if it plays out like this- Q4'14 ($52M), Q1'15 ($46M), Q2'15 ($41M), Q3'15 ($38M), Q4'15 ($36M). That totals $213M. And what if MTC quarterly revenue hits $10M by Q4'15 and Cobi hits $20M by then? The burn rate entering Q1'16...$6M per Q. It's not complicated, just listen to the conference calls.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Nov 24, 2014 5:37 PM Flag

    Your understanding of the facts, is one way to say...you really don't know for certain. Here's a few points to counter-
    1) Convertible can be converted into common stock at $5.31 in 2019, which with approval in RCC or HCC, or expansion of Cobi indications, is highly likely.
    2) This BS about Roche passing on Cobi development costs before EXEL would recognize any revenue. First of all the drug has already been submitted for approval in the EU. In the EU EXEL is entitled to a low double digit royalty on net sales. That's plain English. There are no "development" costs incurred in a royalty payment. In the US it is based on profit/loss share which clearly would include marketing costs. However development costs are not capitalized for drugs, as per GAAP development expenses are to be expensed as incurred. Even if Roche could pass on development expenses to EXEL, those expenses would be amortized over the projected life of the drug or patent, not taken all up front upon commercialization.
    3) The Deerfield notes, if extended, are also payable through the issuance of common stock. Again, while this is dilutive, assuming the approval of Cabo in either RCC or HCC, EXEL could use this option to preserve cash until those indications ramp up sales. And so we are clear, Cobi could be monetized, with the caveat that they pay 50% of the Deerfield notes balance in cash. Same for Cabo, with a 100% cash payoff of the notes required.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Nov 21, 2014 5:57 PM Flag

    This board is turning into the card game from One Flew Over the Cuckoos Nest....see if you can identify which poster is Martini? LOL

    Sentiment: Strong Buy

  • Reply to

    More on Cash & Debt

    by duckduffer Nov 19, 2014 12:26 PM
    duckduffer duckduffer Nov 21, 2014 12:36 PM Flag

    All the debate around unknowns made me want to suggest the importance of what's known.

    We now know that Cabo was designed to address the hypothesis that VEGFR and MET inhibition is key for efficacy in treating clear cell RCC.
    We also know that the Phase 2 trial, with all the caveats (small trial, single arm, etc), had a median PFS of 12.9 months. That was in a group of patients that were on their third line of therapy (minimum of 2 prior systemic agents).
    We know that for the METEOR study to hit trial endpoints, Cabo will need to demonstrate a 7.5 month PFS. This patient sub set was required to have one prior VEGFR TKI set of therapies.
    We know that Cabo has performed well in trials with PFS endpoints (ie no confounding issues).
    We know that RCC is a $1.7B worldwide market with 20,000 drug eligible patients in the US alone.

    Based on what we know, METEOR sounds pretty promising to me.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    More on Cash & Debt

    by duckduffer Nov 19, 2014 12:26 PM
    duckduffer duckduffer Nov 20, 2014 3:33 PM Flag

    The Deerfield extension is baked in. The warrants, which are limited to 1M shares, are barely dilutive and will actually raise a little cash for the company if Deerfield decides to exercise. The increase in interest on the debt is obviously significant, but less than $2M per quarter. I'm sure EXEL would rather find another way to extend that debt due to the hefty interest, but the cost is already baked into their model. While many believe this management team has been flying by the seat of their pants, the plan of action so far, in the face of a Comet failure has been very strategic. The cash raising last January was a perfect example. A very unpopular move at the time as the PPS was moving up rapidly. But it turned out to be incredibly smart to hedge their cash position at $8 PPS. If you had the chance to hear MMM discuss the outlook for RCC approval based upon a PFS endpoint, the optimism was very clear. He also disclosed that the design of Cabo was modeled around addressing pathways common to RCC. Cabo was built for efficacy in this indication.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Nov 19, 2014 12:26 PM Flag

    The cash situation, while always a concern with biotechs, is not the dire straits some have suggested including the Seeking Alpha pundit with no position (ahem) in the stock :) It is now apparent from the CC that EXEL will finish 2014 with roughly $230M in cash. It's also clear that the burn rate is gradually declining and should slow down to roughly $40M per Qtr in 2015. Revenues from MTC are growing and should exceed $30M next year. Revenues from Cobi, with Fastrack approval in the front half of the year, could start in the back half and ramp up quickly, lets say anywhere from $25 to $50M for 2015. Starting with $230M in cash, assuming a cash burn of $160M in 2015, with revenues as worst case $55M, EXEL could finish 2015 with $125M in cash. Even if you assume the worst, that RCC top line is not compelling, EXEL still has a financial runway. Take the outlook into 2016. Cash starts the year at $125M, burn lowers slightly with big trials winding down to $140M, revenues for MTC up to $40M and Cobi up to $80M, EXEL ends the year with $105M in cash. Still not forced to raise cash and over 40 clinical trials either having read out or approaching read out (like HCC). It's pretty clear the runway for EXEL can easily be much longer than many are suggesting. Don't believe the BS being posted about EXEL being similar to DNDN. It's simply not true. I already have posted about the difference in the convertible debt. It's light years different.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Question for Ernie Werner

    by icprecipice Nov 17, 2014 1:35 PM
    duckduffer duckduffer Nov 18, 2014 1:27 PM Flag

    "u see what it did to dndn....and they were pulling n 300k a yr off provenge"

    I'm glad you mentioned this. The DNDN situation is different from EXEL in two key ways. First off...DNDN's convertible debt was structured with a conversion price of $51 per share. That equates to a valuation for DNDN of $8.5B in order for those convertibles to be exercised into common stock. Yep. That is what the company would need to be worth in order to avoid refinancing or paying off that debt. So despite $300M in sales....no chance. That is a completely untenable situation. Second, Provenge is expensive to make and even with $300K in annual sales and relatively low debt servicing, they were unable to turn a profit. No profit, no cash flow, money runs out, period.

    Compare to EXEL. First the convertibles for EXEL have a conversion price of $6.90. That values the company at roughly $1.6B to become eligible for conversion. Very attainable situation. As EXEL revenues from MTC, Cobi, (RCC,HCC,NSCLC,etc) continue to increase, stock goes over $6.90 and EXEL issues common shares to the convert holders. Convertible debt be gone. Dilutive yes. But that comes with the territory. Second is profitability. MMM is currently demonstrating that as trial costs start to wind down and company infrastructure has been downsized, costs have significantly declined. Cabo is a much less expensive drug to manufacture than Provenge. Cobi's manufacturing costs are incurred by Roche. EXEL is a lean, lean, machine and the revenue threshold for profits is much lower than DNDN.

    Another positive for EXEL is the ability to monetize one of their assets (Cobi, Cabo, XL888) should it become necessary to raise cash. DNDN could not monetize Provenge to raise cash.

    GLTA

    Sentiment: Strong Buy

  • Reply to

    Nice to see a "positive" news item!

    by enabeler Nov 16, 2014 10:45 AM
    duckduffer duckduffer Nov 17, 2014 5:24 PM Flag

    The news has been overwhelmingly positive for the last several months, with one exception, Comet 1. Positive news on Cobi, positive news on MTC OS, XL888, EGFR Wild-Type NSCLC, cash projections, etc, etc. However, many of the institutional owners downsized their positions as short sellers kept increasing their positions resulting in strong headwinds for the PPS.
    On the other hand, almost all of the tutes kept a significant stake in EXEL. If they were all as negative as some of the posters here, it's doubtful they would have stuck around at all. Take a look. FMR, T Rowe Price, Meditor...downsized positions but still here. State Street added 4.2M shares and a new holder bought 5.1M shares (Great Point Partners). It was intriguing to see a healthcare fund (Great Point) take an $8M position after the Comet 1 failure. Will be interesting to see if some of those who downsized, add to their positions prior to the end of this quarter.
    GLTA

    Sentiment: Strong Buy

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