Sat, Nov 22, 2014, 9:31 PM EST - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

VirnetX Holding Corp Message Board

duckduffer 96 posts  |  Last Activity: Nov 21, 2014 5:57 PM Member since: May 29, 2003
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • 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

  • Reply to

    Cabo with Immunotherapy

    by wildbiftek Nov 13, 2014 10:46 AM
    duckduffer duckduffer Nov 14, 2014 11:19 AM Flag

    The question is why are they notifying (on the CC) the market of their intention to extend with Deerfield so early in the process? Perhaps the certainty of the extension is perceived to be a positive to the market. I can't help thinking they would like to see other options develop before March 31, due to the high cost of the financing. The warrant repricing is insignificant, its limited to 1,000,000 shares and would actually raise a little bit of cash in the process.
    The monetization of Cobi would resolve all the cash challenges, but it's clear they want to see the PD-L1 data prior to doing anything. As mentioned before, what is already a valuable asset in Cobi, becomes a more valuable asset with good data. There is a possibility of early Cobi/PD-L1 data prior to end of March, as the trial started recruiting in Jan. That could certainly change the game if Roche decides they want to own Cobi outright.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Cabo with Immunotherapy

    by wildbiftek Nov 13, 2014 10:46 AM
    duckduffer duckduffer Nov 13, 2014 7:14 PM Flag

    No doubt there is no near term sales revenue coming from these studies. However, EXEL's "debt hurdles" can also be overcome with positive developments due to it's IP. While these studies may appear to be only of academic interest, perhaps they also hold the key to a future partnership or development agreement that extends EXEL's cash pipeline. If Cabo has significant synergistic value to immunotherapy in human beings....that's worth big $$$$. Just as if Cobi tied positively to a PD-L1 regime that would also greatly enhance its value. There are buyers for IP. Not saying EXEL will sell anything, but there are more ways to deal with EXEL's "debt hurdles" than perhaps are being considered by the market.

    Sentiment: Strong Buy

  • Reply to

    cabo in RCC phase 1 in 2012

    by zoomlik Nov 7, 2014 12:15 AM
    duckduffer duckduffer Nov 7, 2014 12:49 PM Flag

    Where do you see Ohad Hammer suggesting 30% chance of success in RCC? That was his estimation for Comet 1, but I've not seen him estimate that for RCC. Remember the primary endpoint for RCC/Meteor is PFS.

    There is never a 100% certainty in clinical trials even with positive early trial results. But when Ohad suggested a 30% chance of success for Comet 1, it was in an indication, mCRPC, that had good PFS, but no OS data when the trial was designed. It was assumed that good PFS, clear activity in both soft tissue and bone, and pain palliation would lead to clinically meaningful OS. When the OS data did surface from the RDT at 10.8 months, Comet 1 was already underway. And yet...it would still have met trial OS endpoints if not for unexpected improved survival among the control (prednisone) group.

    RCC/Meteor is a completely different animal. EXEL had outstanding PFS data in hand when they designed this trial. The odds here of success on the PFS endpoint are probably more like 75%.

    So if these were trials held in a court of law, Comet 1 was based on circumstantial evidence. Meteor is based on DNA evidence found at the crime scene.

    GLTA

    Sentiment: Strong Buy

  • Reply to

    Shorts and Tutes

    by duckduffer Nov 6, 2014 4:02 PM
    duckduffer duckduffer Nov 6, 2014 7:30 PM Flag

    Wilder,
    To emphasize your point here are a couple of statements made by Ohad Hammer-
    Re-Cobi
    "Roche is evaluating cobimetinib in several other trials, including a combination trial for cobimetinib with its PD-L1 antibody. Any positive indication that ties cobimetinib to a PD-L1 regimen could have a dramatic effect on the drug’s market potential"
    Re-Cabo
    "Additional tumor subsets with RET fusions may emerge, further expanding RET inhibitors’ market opportunity. For example, a recent paper describes a previously undescribed RET fusion in secondary AML which appears to be an oncogenic driver."
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Shorts and Tutes

    by duckduffer Nov 6, 2014 4:02 PM
    duckduffer duckduffer Nov 6, 2014 7:26 PM Flag

    Peak projection sales for-

    1- MTC - USA $40M
    2- MTC - EU $20M
    3- Cobi/zel attributed to EXEL in USA $100M
    4- Cobi/zel attributed to EXEL in EU $40M
    5- NSLC sales $80M
    6- RCC if successful $200M

    Sentiment: Strong Buy

  • duckduffer by duckduffer Nov 6, 2014 4:02 PM Flag

    The institutional holding filings are due on the 15th which will provide some insight as to what happened from a buying and selling perspective after the Comet 1 results. It's possible some of the institutional selling will provide some near term capitulative buying...ie some of those who sold, took the loss for Q3, will reenter EXEL for a year end position awaiting RCC topline. This should provide some fuel for the PPS.

    The short interest report coming on Monday will be interesting. Just exactly how many shares need to be covered now that EXEL's future is becoming significantly more tangible. If there are shorts banking on this PPS going much lower, they are fooling themselves. It was one thing to bet on a negative outcome for Comet 1. There were critics of the trial design from day 1. Comet 1 is history and where is EXEL today? No dilution through 2015. RCC topline by Q2. Cobi/Zelb being touted as a "standard of care" for BRAFV600 MM by Roche with FDA filing by EOY. MTC sales for Cabo improving every quarter. Cabo OS in MTC with RET M918T mutation outstanding (25.4 month benefit) showing that in the right patient subset, Cabo is the bomb .XL888 now getting some interest ie value. Cabo NSCLC phase 2 demonstrating highly stat sig data and meeting trial endpoints of doubling PFS. More CTEP studies that initiated in 2012 will begin to read out. Who knows what other nuggets of gold are sitting in that group?

    The shorts were throwing out FUD by the buckets after Comet 1. It's pretty clear now that although mCRPC is not the homerun ball we thought it could be, there are a bunch of singles, doubles, and even triples lining up in the batters box.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Conference Call

    by najarian_t Nov 4, 2014 6:47 PM
    duckduffer duckduffer Nov 4, 2014 7:05 PM Flag

    In addition to the good CC relating to trial updates, the news regarding cash was very significant. No cash needs through end of 2015. More time to ramp up Cabo MTC and Cobi MM sales. Figure a Fast Track FDA approval for Cobi/Vemurafenib in early 2015 with significant revenue by Q3. Cabo/Cobi could account for well over $100M in revenue just in 2015. The biggest drag here has been Comet 1 results, but number two has to be cash concerns. I'm certain the shorts won't agree, but it appears cash position has moved way down in terms of risks.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    EXAM OS, wild-type EGFR NSCLC, and XL-888

    by wilderguide Nov 4, 2014 5:42 PM
    duckduffer duckduffer Nov 4, 2014 5:54 PM Flag

    If XL888 data is compelling, could this be the impetus for a Roche deal? EXEL's Cobi is partnered already with Roche. XL888 is not. Hmmm....

    Sentiment: Strong Buy

  • duckduffer duckduffer Nov 4, 2014 4:56 PM Flag

    Good news on Cometriq sales as well. Over $8.1M not counting the one-time project management fee of $1.8 million payable (net $6.4M) to Exelixis’ European distribution partner. The fee it impacts Q3 results but in 2015 we will see the full amount. We are positioned to see a $40M revenue figure for MTC sales next year. It all adds up :)
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Nov 4, 2014 4:22 PM Flag

    ...the trial met its primary endpoint of improving progression-free survival (PFS) with cabozantinib alone and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone, and the results were highly statistically significant....Assuming exponential survival, this corresponds to a 100% improvement in the median PFS...
    This might be an indication they can file for approval off this Phase 2 data. Nice....
    GLTA

    Sentiment: Strong Buy

  • Another Phase 2 combo trial only this one is with Cabo/Herceptin (Roche). Hmmmm.......

    Official Title: A Phase II Study of Cabozantinib Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
    This study is not yet open for participant recruitment. (see Contacts and Locations)
    Verified October 2014 by Dana-Farber Cancer Institute
    Sponsor:Dana-Farber Cancer Institute
    Collaborators:
    Exelixis
    Genentech, Inc.
    Information provided by (Responsible Party):
    Sara Tolaney, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02260531
    First received: September 17, 2014
    Last updated: October 6, 2014
    Last verified: October 2014

    Sentiment: Strong Buy

  • Reply to

    wow fast track has been granted by the FDA

    by franca_ole Oct 17, 2014 8:25 AM
    duckduffer duckduffer Oct 17, 2014 5:23 PM Flag

    " I expect EXEL to report revenues from cobimetinib by the 2nd quarter of 2015."
    And the best part, in addition to patients getting better outcomes, is that Zelboraf already has a big marketshare. This is a bolt on improvement to an existing success. Revenues won't gradually build like a normal drug launch, they will start out strong and build from there. Even if it's only 100-150M per year to EXEL, it's cash flow and should mean less dilution when we get to that point. Some of the WAG estimates have dilution doubling after RCC reads out in order to fund the ongoing clinical trials. The speed of this approval process could have a very positive impact on that need for cash, meaning a much smaller dilution impact to long shareholders.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    13G

    by clemcaldwell Oct 12, 2014 4:15 PM
    duckduffer duckduffer Oct 12, 2014 6:18 PM Flag

    Looks like Fidelity was one of those tutes who did a little end of Q selling/window dressing. Not surprising as we all witnessed the PPS move up strong on the Cobrim data then get sold off during the same session on high volume. Combine this with the uptick in short interest of 10% (nearly 5M shares sold short) during the same period (Sept 15-30th) and it's not surprising the PPS has been unable to move up.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    time to..

    by urabt2 Oct 4, 2014 2:00 PM
    duckduffer duckduffer Oct 5, 2014 1:38 AM Flag

    Sorry but my background doesn't align with your opinion of BODs. You can't stereotype this function. What I don't understand is with your work experience how you didn't realize that Comet was a swing for the fences. That was obvious. If it had gone as planned, we would all be as Ernie Werner stated "in tall clover". The reason I stayed with this play through Comet, especially after seeing the OS from the RDT was 10.8 months, was the backstop of Cobi, RCC, HCC, and NSSLC. All worthy indications with significant revenue opptys. It was clear Comet was a risky bet. But if it played out...huge. It didn't, but all is not lost. I like our chances.
    GLTA

    Sentiment: Strong Buy

VHC
5.26-0.18(-3.31%)Nov 21 4:02 PMEST

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Hexcel Corp.
NYSEFri, Nov 21, 2014 4:02 PM EST
Celgene Corporation
NasdaqGSFri, Nov 21, 2014 4:00 PM EST
BHP Billiton plc
NYSEFri, Nov 21, 2014 4:02 PM EST