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Robinho

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  • More Growth To Come For Teekay Tankers [View article]
    I like the deal. 5 Aframax vessels for a purchase price of $230mm and an average age of 3.8.. these vessels were verly likely purchased below the vessels' intrinsic value based on a DCF analysis, NAV value enhancing.

    Bank of America Merrill Lynch upgraded TNK to buy and increased price target to $7.00 based on an "improving tanker fundamentals on lower crude prices and improving execution"
    Dec 20, 2014. 11:19 AM | Likes Like |Link to Comment
  • Teekay Tankers -14% on 20M-share offering, UBS downgrade [View news story]
    I like the deal. 5 Aframax vessels for a purchase price of $230mm and an average age of 3.8.. these vessels were verly likely purchased below the vessels' intrinsic value based on a DCF analysis = NAV value enhancing.
    Dec 20, 2014. 11:17 AM | Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]
    Snippets from Management Meeting Takeaways - source: Brean Capital

    "MM-398, (...) Baxter was among 38 companies that considered partnering MM-398, so it was far from alone, and we believe that it was important for Merrimack to reserve US rights for itself (...)

    MM-121, (...) addresses a potential multibillion dollar opportunity. Merrimack is amenable to developing MM-121 itself, but re-partnering the drug probably makes more sense. Sanofi returned the drug to Merrimack last June, but we note Sanofi's oncology division setbacks (Taxotere losing patent protection, underwhelming sales of Zaltrap) combined with a self-funding oncology division philosophy, more than likely contributed to its major 2013 downsizing that impacted oncology R&D spending, rather than the attributes of MM-121. (...)

    MM-302, an ErbB2 antibody targeted liposome containing about 30,000 molecules of doxorubicin per particle, is presently being tested against physician's choice on top of Herceptin background therapy in anthracycline-naive, HER2-positive MBC having had prior pertuzumab and T-DM1. Enrollment in this Phase 2 trial started in August 2014 and the FDA indicated that clinically significant data would be considered for Accelerated Approval. (...)"

    I think we can put the "oooh Sanofi walked away, they are so smart" bear case to bed....n'est pas?
    Oct 3, 2014. 05:23 PM | 2 Likes Like |Link to Comment
  • Update: Merrimack Licenses MM-398 - Value Potential Dramatically Improves [View article]
    Decision A, chapeau for all your insights you share with us. Mack's future is bright, no doubt.


    "Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) announced today additional clinical and biomarker data from a Phase 2 study in ER/PR-positive, HER2-negative metastatic breast cancer showing that patients with high heregulin mRNA levels achieved a statistically significant benefit from combining the novel agent MM-121 with exemestane. Updated data from this biomarker subgroup, representing 45% of patients with metastatic breast cancer, showed a hazard ratio of 0.26 with a p-value of 0.003. (...)

    These new data underscore the importance of ErbB3 and the enormous medical need and opportunity for MM-121," said Robert Mulroy, President and CEO of Merrimack Pharmaceuticals. "The prevalence data across the 800 patient Phase 2 program supports our initial hypothesis that MM-121 has the potential to play an essential role in the improved treatment of hundreds of thousands of patients in the US alone, representing up to one third to one half of solid tumors."

    Pro memoria:
    Robert Mulroy, President and Chief Executive Officer:
    " We are thrilled to have full ownership of MM-121"
    Event Date: 06/26/2014
    Event Description:ESMO GI Investor Call

    I am thrilled, too.
    Sep 30, 2014. 12:44 PM | Likes Like |Link to Comment
  • Update: Merrimack Earnings - Looming Concerns Still Remain [View article]
    $100M upfront payment for partnership
    up to $120M in regulatory milestone payments related to the first pancreatic cancer indication
    up to $220M in development and regulatory milestone payments for two additional indications
    up to $250M in sales milestone payments and tiered royalties on net sales of MM-398
    up to $280M in development and regulatory milestone payments for a second pancreatic cancer indication
    -----
    boooooooooom
    Sep 24, 2014. 07:55 AM | 1 Like Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]

    I found the strong change in Adiponectin levels (300mg aramchol vs placebo) from baseline to end of treatment interesting.

    "Both mild weight reduction and increased levels of serum adiponectin were associated with high dose aramchol treatment (p=0.1 and 0.088, respectively)"

    Adiponectin can improve insulin sensitivity and acts as an anti-oxidant, an anti-inflammatory, and has anti-fibrotic effects on the liver. Reversing the decrease in adiponectin levels commonly observed in NAFLD and NASH patients may help facilitate the benefits of aramchol on patients’ livers.1

    1"Visceral obesity is a main risk factor for NAFLD and inappropriate storage of triglycerides in adipocytes and higher concentrations of free fatty acids may add to increased hepatic lipid storage, insulin resistance, and progressive liver damage. Most of the adipose tissue-derived proteins are elevated in obesity and may contribute to systemic inflammation and liver damage. Adiponectin is highly abundant in human serum but its levels are reduced in obesity and are even lower in patients with hepatic steatosis or NASH. Adiponectin antagonizes excess lipid storage in the liver and protects from inflammation and fibrosis. This review aims to give a short survey on NAFLD and the hepatoprotective effects of adiponectin."

    http://1.usa.gov/1socrXp

    But you are the expert, I have just begun to do my homework here. Thanks for the exchange of thoughts.
    Sep 24, 2014. 01:28 AM | Likes Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    Thank you Paul for your quick response. First things first: no, I dont think it is better than Genfit (mcap $1.2bn) or Intercept ($6bn) which I like both but the reason why I will put more work into it is pretty pragmatic: Galmed's aramchol is apparently targeting NASH patients prior (!) to development of fibrosis or cirrhosis, and could therefore be able to capture at least a part of the NAFDL/ Nash market without being in direct competition to ICPT or Genfit.

    Snippets which caught my eye so far:

    Aramchol is a partial SCD1 inhibitor that functions to decrease the amount of monounsaturated fatty acid synthesis, leading to decreased fatty acid storage in the liver. In addition, aramchol works to increase reverse cholesterol transport (RCT), a pivotal step in the cholesterol lifecycle.

    Recently published Phase IIa data indicate that aramchol can significantly reduce liver fat in patients with nonalcoholic fatty liver disease (NAFLD) and NASH: Sixty patients were randomized to aramchol or placebo, and patients in the aramchol group experienced a significant decrease in liver fat of 12.6% compared to an increase of 6.4% for patients in the placebo arm (p=0.02), which was the primary endpoint.

    The data from Galmed’s Phase II trial support a safety profile similar to placebo, as no treatment related serious adverse events were reported in patients receiving aramchol...in terms of cardiovascular measures, there were no changes in total cholesterol or LDL levels during treatment..

    Galmed is planning to use the same primary endpoint as their Phase IIa, which is liver fat reduction as measured by MRI, and a secondary endpoint of resolution/improvement in NASH (complete resolution or an improvement of 2 points in NAS score):
    "The Phase IIb trial is expected to be a multi-center, randomized, double-blind, placebo-controlled study and enroll 240 patients with biopsy- diagnosed NASH who are obese and have insulin resistance. The inclusion of obese and insulin resistant patients is consistent with the potential for aramchol to impact features of metabolic syndrome as part of the mechanism for treating NASH. Patients will be randomized in a 3:3:2 ratio to receive 400 mg aramchol, 600 mg aramchol (vs 100 and 300 in pIIa), or placebo. Aramchol will be administered once daily for 12 months. The primary endpoint will be the reduction in liver fat content between aramchol-treatment and placebo as measured by MRI. Secondary endpoints include improvement in or clearance of NASH as measured by liver biopsy and NAS, and the change in various liver and metabolic markers. " LifSci Report

    Interim data from the Phase IIb study may be available in the third quarter of 2015.

    The FDA has cleared Galmed’s investigational new drug application (IND) for aramchol, and granted FDA Fast Track designation.

    I have opened a small long position and might increase the position. Downside appears limited imho at a mcap of $90m (with apperently 30m+ in cash on balance following its ipo in March). Will keep you posted Paul.
    Sep 23, 2014. 05:45 PM | Likes Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    Sept. 23 (Bloomberg) -- Galmed Pharma’s aramchol gets FDA fast track designation for treatment of non-alcoholic steato-hepatitis (NASH).

    does anyone know the company`?
    Sep 23, 2014. 11:35 AM | 1 Like Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]


    Ross, see below two recent broker comments for further information.

    From recent contact with management we note that Genfit's next major catalyst, data from its phase II study, is due at the beginning of Q2 2015. The group has learnt the lesson from Intercept, which released data from the phase II trial on OCA in several stages. As a result, Genfit is to wait until all of the data is fully available for phase II before publishing. The message could therefore be particularly successful and convincing. (...) our blue-sky scenario two years out indicates a potential of € 123 per share.

    http://bit.ly/1qUhHQ7

    Our base case is a 60% prob of success. We assume sales of $9B (or 7B euros) for GFT-505. From our deep dive analysis, we have built an integrated model for NASH. We estimate the entire market oppy is $35-40B. We model 500k patient treated at peak with GFT-505. Our 110 euro TP is based on a prob-adjusted DCF analysis.

    http://bit.ly/1qUhHQ9
    Sep 14, 2014. 06:36 AM | 1 Like Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    sounds sensible.
    Sep 10, 2014. 10:50 AM | Likes Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    Hi Ross
    I am glad to own shares in Genfit and I hope others followed suit.

    Ph2b study (N=270) in NASH (Golden) is looking at 2 doses (80 and120mg) of
    GFT-505, primary endpoint is NASH clearance which I believe is an approvable endpoint for Ph3 (differes from ICPT`s Flint imo). Readout expected in Q1 2015.

    DBK assumes sales of $9B for GFT-505 in a $35-$40B market opp’y in NASH.

    Note, GFT-505 has a long patent life till 2035.

    Interesting comment by Dt Bank on safety:
    "PPARs (peroxisome proliferator-activated receptor) belong to a class of nuclear
    receptors that regulate the expression of lipid and glucose equilibrium. PPARs
    are anti-inflammatory and potentially anti-fibrotic. PPAR biology has been
    around for a long time. There are three types of forms: alpha, gamma, and
    delta. Each PPAR isoform is associated with different effects. Many combos
    have been tried of the isoforms. Those using gamma typically had safety
    issues. GFT-505 is the first of its kind to test alpha/delta agonism. It does not
    affect Gamma"

    "Additionally, lipid parameters including LDL move in the right direction in ALL
    studies. This is an important difference from Intercept’s OCA that is known to
    have LDL increases" (although I think these concerns have eased recently)
    "In four Phase 2a studies where lipids were studied, GFT-505 showed favorable
    affects on all four lipid parameters (LDL, HDL, trigs, and X)"

    Genfit press-released on June 27, 2014 that DSMB had looked at all
    safety data include and still saw no concerns. They looked at about 120
    patients since launch at 80mg who now have already competed 80mg.

    Upcoming roadshows
    Goldman Sachs Biotech Symposium Date: September 5, 2014 1x1 meetings Location: London

    Trout Group Wall Street Unplugged Conference Date: September 11-12, 2014 1x1 meetings Location: New York City

    Kepler Cheuvreux Autumn Conference Date: September 17, 2014 Biotech Roundtable & 1x1 meetings Location: Paris

    Bank of America Global Healthcare Conference 2014 Date: September 19, 2014 1x1 meetings Location: London

    Hope that helps. Fingers crossed. I am constructive on Genfit ($1.3bn, ISIN FR0004163111) but also ICPT ($6bn mcap, ISIN US45845P1084) is compelling. So I dont want to kick off a debate one against the other, rather than saying that the market opportunity looks great for both.

    good luck to all
    Sep 10, 2014. 09:37 AM | Likes Like |Link to Comment
  • Update: Merrimack Earnings - Looming Concerns Still Remain [View article]
    (Bloomberg) -- Merrimack Pharma up as much as 9.1%, most since May 5, on ~1x average 3-month daily volume.
    * High short interest combined with a “decent” clinical
    update are at work, Mizuho analyst Peter Lawson said in an
    interview
    * Coming catalysts include an analyst day in the fall, MM-111
    biomarker data at ESMO (Madrid Sept. 26-30), one year
    survival data for MM-398 “at an upcoming conference” and
    FDA submission of MM-398 by year-end: Mizuho
    * ’Golden Cross’ (50-DMA above 200-DMA) chart
    * Short interest 21% of float: Markit
    Aug 14, 2014. 11:44 AM | 1 Like Like |Link to Comment
  • Update: Merrimack Earnings - Looming Concerns Still Remain [View article]
    ...20% short interest.. 16x days to cover.. MACK ripping higher +7%
    MM 398 partnership next.
    Aug 14, 2014. 09:59 AM | 2 Likes Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    I bought the first shape at around €7 but there was not research at all available hence my position was just a fraction of what it should have been. I am following the stock since.
    From what I understand: There are three types of forms: alpha, gamma, and delta. Each PPAR isoform is associated with different effects. Many combos have been tried of the isoforms. Those using gamma typically had safety issues. Genfit`s 505 is the first of its kind to test alpha/delta agonism. It does not affect Gamma. PPAR alpha and delta inhibitors increase fatty acid oxidation. Fatty acid oxidation gets rid free fatty acids which make up free triglycerides. From reviewing their preclinical and clinical data the hypothesis is that GFT 505 improves: 1) lipid metabolism, 2) insulin sensitivity, 3) anti-inflammatory, and 4) anti-fibrotic actions. All of these activities combined should have an impact on NASH. GFT-505 showed no cases of cardiac insufficiency in Ph2 studies. As per DBK`s research report: "Over 600 patients or healthy volunteers have been studied with GFT-505, and we have seen no safety signals related to CV or weight". Interestingly, lipid parameters including LDL move in the right direction in ALL of Genfit`s studies. This is probably an important difference from Intercept’s OCA that is known to have LDL increases.
    Genfit`s PPAR alpha/delta receptors likely work in other indications as well, such sclerosing cholangitis and ulcerative colitis. Genfit has run 5 Phase 2 studies in various populations with metabolic disease.

    Genifit gained fast track for 505 designation in spring. Keen to hear your thoughts.
    Keep up the good work.
    Jul 15, 2014. 11:04 AM | 2 Likes Like |Link to Comment
  • Intercept Pharmaceuticals (Part IIa) - Quick Takeaways On OCA From EASL Abstracts And Presentations [View article]
    Interesting peer called Genfit.

    apparently no safety issues:
    Lille (France), Boston (Massachusetts, United States), June 27th, 2014 – GENFIT (Euronext: GNFT ; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal systems, today announces the recommendation of the independent Data and Safety Monitoring Board (DSMB) of international experts charged with ensuring the safety of use of GFT505 in the ongoing Phase 2b study.
    The experts of the Data and Safety Monitoring Board in charge of assuring the security of patients in the GFT505-212-7 trial, consulted all safety data of the patients included since the launch of the trial, notably 120 patients who have already terminated the one year treatment period with the dose of 80mg/d and more than half of the patients treated for at least 6 months with the dose of 120mg/d. Based on analysis performed after partial unblinding, the DMSB does not raise any safety concern which might jeopardize the security of the patients and provides its unrestricted approval to continue the Phase 2b clinical trial in NASH as planned in the inititial protocol.

    sell side analysts have begun to take notice
    Jul.14 - Genfit (GNFT FP/$GNFTF) rated new "Buy" at Deutsche Bank by Alethia Young. The 12-month target price is €110.00 (currently at €28).
    DBK: "Genfit is currently a $600 million euro stock (~$800 million USD) market cap stock. We think current share levels reflect ~20% probability of success which
    is too low. Our base case for our target price of 110 euros is a 60% probability
    of success for GFT-505. (...) Currently Intercept is a c$5B market cap company with much of the valuation coming from NASH."
    Jul 14, 2014. 06:05 AM | 1 Like Like |Link to Comment
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