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Visa Inc. Message Board

phorensicguy 11 posts  |  Last Activity: Apr 4, 2014 5:21 PM Member since: Jun 2, 2001
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  • phorensicguy phorensicguy Apr 4, 2014 5:21 PM Flag

    I DO get it. Exubera was definitely a prandial insulin. Evidently, however, you do not get it. Perhaps look up the clinical review entitled "exubera inhaled insulin, a review" by AH Barnett, of the national institute of health. As a declared type one diabetic who hates needles, no doubt you were one of the handful of users during the limited release period?

  • phorensicguy phorensicguy Apr 3, 2014 1:34 PM Flag

    This is not the first rodeo for inhaled insulin. Prior to Exubera being pulled from the market, it sold a whopping $12 million of product, globally, in the first 9 months that it was available.

    "Even before Pfizer introduced the drug in mid-2006, patients were blasting it (BusinessWeek.com, 7/17/06) on blogs and online discussion groups for people with diabetes. Some patients who tried it were anything but enamored. "It was never popular," says Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York. The few patients who did try Exubera, he says, had to endure lung-function tests, and they struggled to figure out Exubera's dosing system. Ultimately, Zonszein says, the patients "just gave up. They preferred injected insulin."

    We shall see if MNKD's product, should it become commercially available and be covered by insurance companies is successful. Pricing of Exubera was 30% higher than conventional insulins and was only available under the most expensive tier, which means higher co-pays. The diabetes market has a long-storied history of supposed breakthroughs; unfortunately, those breakthroughs turned out to have unique challenges when introduced to a control group other than the cherry-picked diabetic ex-navy seals..

    If Mankind does get this product successfully to market, without so many black box warnings that diabetics and doctors alike will feel comfortable going through a reasonable acceptance period, both NVO and Sanofi have a simple competitive solution in the can. They will just bring their own, previously shelved, inhaled products back into their pipeline for approval, without a lot of fuss and bother. There is nothing particularly difficult about breaking down insulin into particulate, to be absorbed into the pulmonary system.

    More than likely, the two major players will probably just wait and see how the true diabetes market reacts, to the supposed next big thing.

  • phorensicguy phorensicguy Feb 27, 2014 4:14 PM Flag

    This is now the 3rd try for Afrezza; the third time might also be the strike out, not necessarily the charm. To assume that a company can just wear the FDA down by resubmitting the same drug for approval is rather naïve. All that MNKD is doing is producing a smaller inhaler for their insulin powder, the insulin is the same as before.

    The problem with inhaled insulins is not effectiveness. Nobody questions whether or not these products work. Exubera, which was produced by Pfizer for a short time, was effective. No, the issue is particulates in the pulmonary system. Diabetics are prone to pulmonary issues at a level that is far higher than healthy individuals. Lung cancer is permanent, diabetes is just chronic. None of the major players want to go out of business in a flurry of lawsuits. PFE tool almost a $3 billion hit when they withdrew Exubera from the market. LLY and NOVO also scrapped their inhaled insulin projects prior to 2010 once their researchers saw the link between inhaled insulin and lung degradation.

    Furthermore, NICE studies published determined that existing diabetes sufferers, when shown the risk factors pertaining to inhaled insulin vs injected insulin, overwhelmingly chose injected insulin. Injections are tried and true and they don't lead to lung cancer.

  • phorensicguy phorensicguy Feb 26, 2014 5:34 PM Flag

    The corollary to this story; if Afrezza is NOT approved by the FDA, after three tries in the last 4 years, is that not ALSO a game changer?

  • phorensicguy phorensicguy Feb 26, 2014 12:38 AM Flag

    Diabetes sufferers are quite sticky; when they find a product that they are accustomed to and are tolerant of, pharmaceutical companies have found it difficult to have reps persuade doctors of the efficacy of switching. Therefore, being "just as good" does little to take market share from the existing players. Furthermore, LLY was very shy on the endpoint details; if dulaglutide was better than Victoza, the results would have been shouted to the heavens.

    Judging by the market reaction from institutional hands, the view is that Lilly's inability to make a claim of superiority for dulaglutide, might, in fact, mean that the product is somewhat inferior when the full details are put forth.

    There is a lot of precedent for this assumption by institutional holders. Endpoint studies typically make some noise that winds up getting watered down by the time the full details are put forth to the medical community. The most recent example of a competing product, Bydureon, was put forth as being just as good as Victoza, when in reality it was a substantially inferior product on almost all counts. The average diabetes patient churn on bydureon was only about six months; it turned out to be a largely intolerable product for patients.

    Whether the product is administered daily, several times weekly or weekly; that's far less important than efficacy and tolerability by the patient.

    A lack of superiority is, in scientific terms, a fail.

    Sentiment: Buy

  • Novo Nordisk shares up almost 5% based upon the dulaglutide once weekly trials. LLY's highly anticipated results did not indicate superiority to Victoza in terms of effectiveness, nor did dulaglutide demonstrate fewer side effects.

    Based upon the studied market reaction to the LLY results, Novo's franchise does not appear to be in any imminent jeopardy. LLY boosters will, of course, disagree with this assessment.

    Sentiment: Buy

  • On February 4th, Mexico's lower house of congress overwhelmingly approved a reform of the rail freight law.

    Under the terms of the bill, existing concession holders will be forced to share their lines with other concession holders or risk losing them. Railroads will also be forced to publish prices they charge for interconnections with routes owned by other companies.

    "The rail proposal has angered Grupo Mexico's subsidiaries and Kansas City Southern de Mexico, who say the bill threatens the 14 years of exclusivity that remain in their concessions, fails to recognize their sizeable investments and sets a worrying precedent as Mexico tries to lure new investors into its oil and gas sector.

    "We don't want to go down the legal path, but we're certainly looking at those options," said Kansas City Southern de Mexico's President Jose Zozaya, who added the company had already begun looking into using an arbitration panel set up as part of the North American Free Trade Agreement (NAFTA) treaty."

    Sentiment: Hold

  • MasterCard CEO indicates in Q4 conf. call that their loss of the Chase portfolio is of such significance that ALL of the MasterCard wins reported for 2013-2014 won't fully offset the loss of business from the Chase conversion.

    Since the entire Chase account is migrating to Visa, the implication is that V might finally report revenue growth above that of MA in 2014. Accordingly, and since V earns higher margins from its business, there could be positive earnings surprises, for the rest of 2014, at Visa.

    Sentiment: Buy

  • Company is looking for revenue growth at the lower end of 11%-14% guidance. This is due to the loss of the Chase portfolio that was previously announced. All of the portfolio wins that were previously announced won't fully offset the loss of the Chase portfolio.

    The company is still guiding for 20% eps growth. They suggest that M&A activities might knock $.01-$.02 per share off of 2014 guidance.

    MA indicated that forex had some negative impact upon 4th quarter results. Should Brazil and the Euro continue to trade around current levels for the balance of the year, this headwind should abate in 2014.

    According to January figures reported thus far, MA indicates that Europe and US volumes had slightly accelerated beyond 4th quarter numbers.

    The headwind for 2014 looks to be the loss of the Chase portfolio. Should revenue growth come in towards 11%, analysts will uniformly be lowering targets for 2014.

    Sentiment: Buy

  • looks to be Forex. Visa's commentary this AM mentioned a significant foreign exchange headwind. This had proved out to moderately reduce V's reported rate of revenue and earnings growth.

    As MA generates far more of its reported revenues and earnings in currencies other than US dollars, there might be some possibility that earnings might not beat at the historic rates.

    HOWEVER....Visa also noted that MA had increased cross-border assessments by percentages above that of Visa. Visa evidently failed to increase their own assessments in line with MA and there wasn't any pushback to speak of, from merchants, at the assessment level. V might now seek to move up their assessment level in line with MA. That assertion, when taken at face value, might imply that MasterCard could have earned a bit more than expected from that fee.

    Sentiment: Buy

  • Shares were punished on Friday due to the overall market selloff and a perception, reinforced by management in the conf. call, that earnings GROWTH would abate in 2014-2015.

    The 2013 drivers for KSU were crude oil transport, grain transport recovery, a bottoming of coal deliveries and general overall improvement in various other products to be hauled as US economic recovery improves. Management was feted for being able to grow revenues faster than opex. Forward expectations were high based on Mexican automotive plant startups for 2014.

    What management acknowledged, in the conf. call, was that automotive production from the new Mexican plants would come on line on a far more gradual basis. They indicated that crude oil shipments had fallen in Q4 and growth might not resume in that sector anytime soon. Eastern refineries are now taking up as much of the Bakken output as they can, which effectively diverts revenues from KSU. A pending coal-fired generator closure may still remove an additional 6% of coal revenues at KSU.

    Simply put, some of the anticipated tailwinds have moderated; hence the swift rerating of the corporate prospects and share price. US economic recovery will still benefit KSU, as it will any other class 1 rail. Management now will have to prove that they truly ARE excellent managers, rather than being in the right place at the right time. Being locationally advantaged doesn't automatically equate to executive superiority; Q4 opex growth exceeded revenue growth. This blindsided analysts.

    A midteens forecast earnings growth rate doesn't excite investors who may prefer CP, CN and UNP's higher forecast 2014 growth rates. That said, now that the wind has been knocked out of the sails of overly bullish investors, KSU might be getting closer to fair value. 2014 EBITDA might touch $1.1 billion. A takeover for cash and shares only makes sense when KSU is beaten up and the buying has a strong share price.

    Sentiment: Buy

V
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