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rmgillis

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  • AbbVie files NDA in Japan for 12-week once-daily HCV combo med [View news story]
    How many patients are getting 24 weeks of Harvoni? Most are on 8 weeks and the most of the rest should be getting 12 weeks.

    There is good reason to hide the Express Scripts numbers. If they were good enough to help Express Scripts' and AbbVie's SP then ESP would probably release them. Their sweetheart deal provision about the numbers being confidential wouldn't stop them from releasing if they were clearly 'winning'.
    Feb 20, 2015. 12:00 PM | Likes Like |Link to Comment
  • GCVRZ Forum [View instapost]
    Two items of interest to GCVRZ owners in the Sanofi 6-K of 2/5/2015 at Edgar: [specifically the EX-99.1 sublink]
    http://1.usa.gov/1A4Jssg

    [from page 10]

    From business net income to consolidated net income (see Appendix 3)

    In 2014, the main reconciling items between business net income and consolidated net income attributable to equity holders of Sanofi were:
    .
    .
    . [snip]
    .
    .

    · A net reversal of impairment of intangible assets of €26 million (of which €135 million in Q4 2014 mainly related to the partial reversal of the Lemtrada® impairment recorded in Q4 2013 and the partial impairments of the rotavirus vaccine and CHC intangibles in Emerging Markets). This item has no cash impact on the Group.

    · A charge of €303 million (of which €126 million in Q4 2014) mainly reflecting an increase in the fair value of contingent considerations related to the CVRs (€82 million, of which €61 million in Q4 2014) and Bayer contingent considerations (€238 million, of which €83 million in Q4 2014) linked to Lemtrada®.
    Feb 13, 2015. 02:19 PM | 2 Likes Like |Link to Comment
  • AbbVie files NDA in Japan for 12-week once-daily HCV combo med [View news story]
    Here's the analogous GILD NDA for Genotype 1 (Harvoni)

    Sep. 24, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin (RBV).

    Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus.

    The NDA is based on data from a Phase 3 clinical trial conducted in Japan (GS-US-337-0113) among 341 treatment-naïve and treatment-experienced genotype 1 patients. In the study, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients receiving 12 weeks of LDV/SOF without RBV achieved SVR12.

    Sovaldi's NDA was June 27, 2014. It had only Phase III 97% cure rate in 12 weeks, but better than ABBV's current NDA for V-pak.
    Feb 12, 2015. 12:31 PM | 3 Likes Like |Link to Comment
  • Awilco Drilling: Hold This Attractive Dividend Payer Through 2015 [View article]
    Net profit up: $1.30. Dividend trimmed to $1.00

    Revenue was down, as expected, with the sublet @440k/day ending last quarter. Earnings were down less than $1M despite over $5M less in revenue. Opex was well under guidance at $85k/day. Net profit actually increased but AWilco is retaining more earnings presumably because of the potential headwinds of the marketplace for 2016 after the Wilhunter has completed its yard stay.

    No word on Hess talks in the financial report. The presentation was not yet on the website. Seems unlikely that the option is to be taken. New work will require a new contract. We have the rest of the year to gain one to allow a smooth transition post-SPS.

    So it was another spectacular quarter. The only question is the next contract for February 2016 forward for WilHunter. If there is work in Decom to be had Wilhunter seems like the top candidate rig in every respect: Performance, experience & equipment i.e.; state-of-the-art Blow Out Preventer.

    4 more quarters like this (on existing contracts) and Awilco has enough extra retained earnings to pay $1.20 to shareholders perhaps to tide over the four known months of idle time a year from now. 1 rig-month downtime in Q4 2015, 2 rig-months downtime in Q1 2016 and one rig-month in Q2 2016.

    No real surprises other than the positive beats on EBITDA and Net Profit.
    Feb 12, 2015. 02:23 AM | 2 Likes Like |Link to Comment
  • GCVRZ Forum [View instapost]
    The rest-of-the-world markets contribute to the total for sales from April 1, 2015 through March 31 2016.

    The 6 Major Markets as yet without sales may launch as late as Dec 31, 2015 and would then have their next 4 quarters count. If a major launches Jan 1 2016 or later, only sales before March 31, 2016 count- same fixed deadline for non-major markets.

    I haven't seen anywhere that France, Italy or Spain have made commercial sales as of Q4. If someone has any info on those launches, I hope they will post it here.

    For those interested: The CVR page at SNY is here:
    http://bit.ly/1ddvwOm

    Be sure to click these two links from the page linked to above.

    Product Sales Statement Q4 2014
    Status of CVR Product Sales Milestone #1 as of January 16, 2014

    Despite the Jan 2014 date, the status document answers many questions.
    Feb 5, 2015. 05:37 PM | 1 Like Like |Link to Comment
  • Awilco Drilling: Hold This Attractive Dividend Payer Through 2015 [View article]
    It seems unlikely that Hess will exercise the relatively short 275-day option. They are apparently finishing up at the Ivanhoe location well ahead of schedule (great work by the WilHunter!). However, they have many more required decommissioning sites/programmes in the UK North Sea and so do other oil majors.

    It's inconceivable that WilHunter will struggle with securing a contract for 2016 forward. The rig & crew have a fantastic track record (including a 96-99% uptime each qtr) and they have the competitive advantage in costs if it comes to that. The UK North Sea is not overflowing with rigs and the marginal rigs are not competitive with WilHunter. New incentives are due soon and Awilco should be in great shape to secure a contract. If Oil prices rise when seasonal demand picks in a few months day-rates may benefit. Remember they will have the very best-in-class mid-water rigs after the BOPs are installed during the early 2016 SPS yard-stays.

    So, I don't believe the unpriced short-term option is something to panic about if Hess doesn't exercise. If, instead they announce a longer contract with Hess , that would blow things out of the water. But don't count on that either.

    Meanwhile enjoy the 40% dividends. Remember, after the 2016 yard stays, Capex will be slashed ($85MM in less than 3 years for BOPs /SPS's with lower dayrates at the beginning), so with full employment, the free cash flow could increase despite a possible marginally reduced dayrate for WilHunter. Also, the relative premium for WilHunter vs potential competing rigs will increase with its new equipment and mild refurbishment.

    Of note, the dividend this quarter will be the last with the 21-22% tax that was ~10% prior to last April (the retroactive effective date of the UK bareboat charter tax hike). AWilco has moved one rig's ownership to achieve increased tax efficiency and expects a 15% rate for Q1 2015 forward. I won't be surprised if the dividend holds even if profits are a few cents short given this coming boost from taxes for Q1 2015. The only reason the dividend might be significantly reduced would be that an attractive, accretive opportunity has been found that has piqued management's interest in this bloody environment that somewhat resembles that surrounding the storied origin of AWilco Drilling.

    If you want an idea of how Awilco has conducted business during the past 5 years, you can read ALL of the quarterly/annual financial and quarterly presentations and conference presentations. It's pretty fascinating. They encountered a few bumps along the way but handled all of them and created an amazingly smooth machine before instituting the massive dividend back in mid 2013. The main thing I came away with is that they say what they plan to do and then they competently deliver over and over. Highly unusual behavior for an investable public company.

    Do you due diligence and enjoy the ride.
    Feb 5, 2015. 02:14 PM | Likes Like |Link to Comment
  • The Power Of Fear: Is Gilead A Buy Or Sell In 2015 After 1st Quarter Guidance? [View article]
    The man only CLAIMED to be selling under cost. Like GILD, his marginal cost of the goods is trivial. Volume is paramount.

    The only real difference is he was selling fakes, and GILD is selling pure (patented synthesized) gold.
    Feb 4, 2015. 11:10 AM | 1 Like Like |Link to Comment
  • Tonix Shares Looking Attractive As Clinical Programs Advance Forward [View article]
    Joe has written a few January 2015 notes on TNXP at his website ($ubscription-based). The Tonix notes are freely visible (so far).

    http://bit.ly/1BXmt37
    Feb 2, 2015. 05:14 PM | 1 Like Like |Link to Comment
  • GCVRZ Forum [View instapost]
    A "major market" which does not have an official launch by Dec 2015 is then lumped in with all the non-major markets.

    So, only sales in Q1 2016 will count for a major market that fails to launch before 2016. Having that first sale by Dec 31, 2015 would add 3 additional quarters (through Dec 31, 2016) and the Dec sale or sales would not count.
    Jan 23, 2015. 04:40 PM | 1 Like Like |Link to Comment
  • Update: Awilco Drilling Earnings [View article]
    Mr Wilson is a bit difficult to understand on the calls. I think he says "Yeah, f-fifteen %", but I listened to it about 20 times. The accent and penchant for filler syllables makes an accurate transcription difficult.
    Nov 14, 2014. 12:35 PM | Likes Like |Link to Comment
  • Update: Awilco Drilling Earnings [View article]
    I heard 15% as guidance twice from the CFO.

    Excerpts from the conference call:

    4:14-4:35 CFO Ian Wilson

    We do expect to see the tax expense improving as we go into next year the guidance that was previously given has been in the region of 15%, but we will continue to have a tax expense cost of 21-22% through quarter four.
    ======================...
    39:14 Clint Edgington of Beacon Hill Investment Advisory:

    And then you think it will move into in that mid to high teens rate that you previously guided to?

    39:20 CFO Ian Wilson: Yeah ...[explanation of restructuring]...
    ======================...
    39:58 Clint Edgington of Beacon Hill Investment Advisory:

    So looking forward into 2015, your guidance would still be in 15-17%, somewhere in that area?

    CFO Ian Wilson: Yeah, fifteen per cent is what we're guiding.
    Nov 13, 2014. 04:50 PM | Likes Like |Link to Comment
  • Awilco Drilling Is Still The World's Most Undervalued Company [View article]
    Tony,

    Awilco stated that this year's CapEx set aside would be $30M. The decision to set aside $45M for state-of-the-art Blow out preventers was announced late in 2013. The required quinquennial SP Surveys scheduled for 2015-2016 are budgeted at $40M. It's hard to predict what the next SPS in 2020 would be for the two rigs. But assuming another $20M each with 5 years to set aside the cash, it seems reasonable to guess that CapEx set asides will be at least $22M less than the $30M annual rate AWilco is putting aside this year. Based on the stated dividend policy, this savings is available for dividends. Actual day rates and operating expenses,taxes, etc will also have a material effect of course.

    Most commenters have not recognized this change in finances once the yard stays are behind us. (Though several others have recognized and mentioned this. ) AWilco has not been explicit on what plans are for the cash buffer in the future and whether the $25M new cash after the refinance has been lumped into the "buffer". Nevertheless, if mgmt is also successful in reducing 2015 taxes to approximately 15% and day rates remain above $350K, 2016 dividends should increase significantly over today's.
    Oct 5, 2014. 02:06 AM | Likes Like |Link to Comment
  • Awilco Drilling Is Still The World's Most Undervalued Company [View article]
    Tony, you make a very good point. As you may know Northern Offshore had contracted to buy the two rigs from Transocean for $750M before they were extensively refurbished. Awilco bought them for under $200M and spent $100M in a major refurb and upgrading project. Buying today actually gives one leverage based on a conservative estimate of the true enterprise value.

    We don't know when circumstances such as rising oil prices, UK incentives for North Sea work, general increase in optimism for offshore drilling, Awilco showing up in a free stock screener like yahoo (the average ultra hi-yield chasing investor still cannot find AWilco using a screener!-- many choose to prop up the doomed WHX or GNI !). Many find it tough to wait out for a stock to return to favor, but being paid 25% + per year makes it a lot easier. (trailing dividend is $4.55 so we are are at 27% at today's price).

    The post yardwork dividend will include savings from the current $30M/yr Capex down to the new set aside for the the 2020 SPS-- that might be $8M / year based on the $40M for the upcoming 2015 SPS not including BOP's.
    Oct 3, 2014. 12:06 PM | 1 Like Like |Link to Comment
  • Esperion Therapeutics: Another IPO After Pfizer Abandons The Only Drug In Its Pipeline [View article]
    ESPR is at $27 today.

    From a Forbes article:

    "Yesterday Esperion announced positive top line results of a phase 2b trial evaluating the safety and efficacy of ETC-1002 alone and in combination with ezetimibe with ezetimibe alone in patients with high cholesterol levels with or without statin intolerance. The results (see below) show that ETC-1002 effectively lowers LDL by itself and in combination with ezetimibe. Perhaps even more intriguing, the reduction in inflammation, as measured by hsCRP, raises the hope of additional benefits, though of course at this point no one can say for sure what this may mean. The company also said that the drug was safe and well tolerated in the study."
    Oct 2, 2014. 06:00 PM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    George Rho has a current article on ACAD that might fill the bill.

    http://seekingalpha.co...
    Oct 2, 2014. 05:18 PM | 1 Like Like |Link to Comment
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