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Post by matt on Jul 15, 2020 7:24:47 GMT -5
Incredibly profitable businesses tend to invite competition (and sometimes corruption to squelch competition). Where’s the competition? That is certainly a true statement, but less so in a highly regulated industry. For a competitor to enter the medical malpractice market they would need to have a reasonable expectation that they could make money which in turn is conditioned on having the databases necessary to forecast future loss claims. Those are not easy hurdles to jump over. There used to be many more malpractice carriers and insurance used to be relatively inexpensive. My wife practiced as a dentist and her first year premium after leaving the army was just $75 (this is about 1983) for an unlimited occurrences policy (an occurrence policy covers any event that causes a claim during the terms regardless of when a suit is brought). Over the next few years her initial carrier completely exited the business, all the remaining carriers moved from occurrence policies to claims made policies (which covers only claims made during the policy period, and provides no future protection without a separate and expensive "tail" policy), and her premium increased to $4,000 by 1992 despite zero actual or even threatened claims. A more than 50-fold increase in annual premium in ten years while insurers are exiting the market does not sound like this is a problem based on lack of competition. At the end of 1992 she sold her practice when we moved overseas for a time, but I always wonder what her premiums would be today had she kept practicing. |
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Post by matt on Jul 9, 2020 13:51:14 GMT -5
Insurance is NOT a “not for profit” industry. Ask Warren Buffett about his insurance holdings, his most profitable businesses. I understand insurance is not a not for profit business. Many things today are not what they were intended to be. Ask Ben Franklin about life insurance for the widows and children of fire fighters in early day Philadelphia. At any rate, from what I remember about Geico, a substantial portion of it's profitability was achieved by reinvesting the float, not necessarily from the core business of the insurance model itself. Indeed that is true for many insurance companies. They charge less in premium than what they pay out in claims with the difference (and profits) coming from gains on short-term investments. Ultimately though, the premium largely reflects the cost of claims and that is just as true in healthcare policies. If every drug was covered on Tier 1 and every procedure was covered with no restrictions, healthcare costs would be substantially higher as would insurance premiums. Medicare figured that out long ago and moved to the fixed prospective payment system in 1984, with most private insurers following suit in 1985 and 1986. It has been a race to the bottom ever since. Mannkind has never done the studies to show that its product pricing is justified by better long-term outcomes. If the drug is not Tier 1 they have only themselves to blame. The need to demonstrate performance superiority for new drugs and procedures has been around for at least 35 years; it should not be news. |
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Post by matt on Jul 8, 2020 9:46:11 GMT -5
Sorry if this is a duplicate. If so, please disregard. Did anyone ever confirm if the Warrants set to expire June 26th were executed? You cannot tell for sure until the Q2 results are filed in which case the money will show in the accounts. That, or someone in Mannkind announces it. What agedhippie said. There is no SEC requirement to announce a warrant exercise so the company is under no obligation to disclose that until the next quarterly financial statements due in mid-August. However, since the share price was well in excess of the strike price I think you can assume that all the warrants were exercised in due course. Those that invest in warrants generally keep very close track of the underlying security prices as the expiration dates approach and even if those individuals don't want to exercise, there is a robust secondary market where they can sell the warrant to another accredited investor. |
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Post by matt on Jul 7, 2020 18:43:04 GMT -5
serious question. Does needing eye glasses satisfy visual impairment? The term likely means visual impairment that is so bad that a patient cannot safely read the numbers on a syringe. If eyeglasses correct vision to something close to normal I don't think that will fly. |
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Post by matt on Jul 2, 2020 10:15:20 GMT -5
Would it be a reasonable suggestion for Mannkind to put expected completion dates for the current phases of their products on their website? That is a difficult thing to do with pipeline drugs. Firstly, TreT is not Mannkind's drug, it is UTHR's drug and just because a company has out-licensed a drug delivery technology that does not give it the right to control the development priorities of the other company. UTHR might, or might not, be fussy about what the label copy says and if the FDA does not want to give UTHR the label they want/need based on the current trial, they may want to do a second trial and that is their decision to make. For most other drugs, Mannkind is shopping for a commercialization partner and it is very hard to put dates to the conclusion of that search. Even if a partner can be found for each of the drugs, it will then be up to the partner to control the research process. Just because Mannkind is eager to enjoy some royalty revenue does not mean that such a project is at the top of the partner's to-do list. The larger the partner the more ability they have to process multiple developmental drugs in parallel so a lot depends on who the partner is. As for timing on TreT, I can't disagree with the previous comment by harryx1. Normally when an already approved drug is simply reformulated into a new delivery form, the process of getting that new formulation approved is relatively straightforward. The key with TreT is to show that results of inhaled delivery are similar to already approved methods, and that the delivered dose can be accurately predicted which can sometimes be tricky with an inhaled formulation. If the data from the Breeze study can strongly demonstrate dosing equivalency, then I think late 2021 / early 2022 market launch is realistic. If FDA is not happy with the data or requires an expanded trial, all bets are off. |
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Post by matt on Jul 2, 2020 7:50:36 GMT -5
According to data online, as of March 2015, the overall drugs sector had an average P/E ratio of about 24.10. According to Yahoo Finance, currently (as of today) Eli Lilly, Merck, Sanofi, UTHR, have PEs of, respectively, about 27, 19, 26, 10. So using a PE of 30 is arguably not conservative at all. It may be a little over optimistic. Of course some BP firms have much higher PEs. But (from what I've read), those are usually atypical and more often or not viewed as bubbles. And Mnkd might hit over $100 even with negative earnings, if it only could capture the imagine of people the way, say, NVAX, did. I won't say that will never happen. Markets are crazy. P/E ratios move over time and tend to be higher for developmental stage companies. During the 2008 financial crisis, the P/E for major pharmas was more in the 15X range and smallish drug companies without a lot of pipeline struggled to manage 8X. In recent years the numbers have been much more attractive for companies with good pipelines. Tiny pharmas with potential blockbuster drug and almost no earnings can come up with multiples in the nosebleed range because with tiny net incomes (assuming they have any income at all) the multiple goes high just because dividing any number by a much smaller number yields a large quotient. However, no pharma company can maintain a P/E is the stratosphere for more than a year or two. Mannkind's issue is that it is still a one-trick pony. The big pharmas all have huge portfolios of drugs and tend not to be overly dependent on a single drug (Pfizer was the exception when Lipitor was still on-patent). The market rewards the broad portfolio with a better P/E because of the inherent stability, and punishes those companies without a broad offering with lower P/E ratios. Don't confuse TS delivery with Mannkind having a deep pipeline; Mannkind is supporting somebody else's pipeline drugs but not their own. If Mannkind wants the kind of respect and P/E that comes from being a diversified drug company then they need to have a pipeline of proprietary molecules. If the company wants to spin the story that they are a great drug delivery partner, then they need to have a portfolio of unique drug delivery technologies and not just TS. Right now Mannkind is neither a broad line drug company with a deep pipeline nor an established drug delivery partner, and the market is not going to reward the company with a big pharma-type P/E ratio. That can change of course, but not with the current business strategy. |
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Post by matt on Jun 30, 2020 13:38:30 GMT -5
Would not tadalafil be too dangerous as an inhalable? Kind of depends on the dose. Yes indeed it does. Tadalafil and similar medications belong to a class of drugs called phosphodiesterase inhibitors, specifically PDE-5. These drugs were initially developed for treating hypertension, which did not work out so well, but Pfizer noticed an "interesting" side effect in men that led to the birth of Sildenafil (better known as Viagra) and all the other ED drugs. Because all PDE-5 inhibitors affect blood pressure, the risk of hypotension is significant and FDA considers that a serious event. Unlike Afrezza, where the patient can inhale some insulin and then do a test with a CGM before taking an adjusting dose, it is not so easy to do that with medication that affects the systemic circulatory system. Unless the dose can be precisely controlled, something that is very difficult to do with any inhaled medication, it will be a uphill fight with regulators. The indicated dose of Sildenafil for PAH is 2.5 to 10 mg via injection, three times a day, which dose not allow a lot of wiggle room, especially if the patient needs dosing at the larger end of the range. |
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Post by matt on Jun 25, 2020 9:20:48 GMT -5
Waiting on matt to chime in about this. In the past when MNKD attended this type of conference it's usually to solicit funds and there was always some sort of dilution. Will it be the same this time? Could very well be the case. The company needs more cash, further Midcap funding is not feasible due to missed sales targets, and except for the last UTHR milestone there are no sources of cash on the horizon that we know about. Meanwhile, the company has a burn rate that has eased a bit but not nearly enough. One way or the other, dilution is coming and the only question is what form will it take. Investor conferences cost money to organize and the organizers are not in it for their health any more than investment banks are Mother Theresa. If any of the investors want to take a run at MNKD it will come at a price and you might expect the PPS to decline. I am good at predicting the direction of price movements, less skilled at predicting the magnitude. However, the recent run up in price on no material news, followed by yesterday's and today's decline also on no news suggests a bit of caution may be in order. |
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Post by matt on Jun 17, 2020 9:24:43 GMT -5
Just curious about the decision on number of shares for his child.... Not claiming about the very low number.... sure... but about the difference.... I have only 1 child so may be I am not the perfect guy to understand it.... but If I had 2 or more I had bought the same amount for all of them... Also curious about the timing: The first was his wife... then the childs and the last was for him (Due to the particular continuous increasing day it is easy to see the timing)...  I don't think you can reach any conclusion about purchases for the children. The form states "by child" which means the source of funds could be grandma, daddy, the piggy bank, or a summer job. Similarly, given the share numbers for the children it might be a reflection of the best bid/ask for fractional lots at the moment the trade was executed. The trade attributed to the wife is different because of the number of shares. Just keep in mind that Form 4 reporting and timing of share purchases by executives are subject to some pretty draconian SEC regulations. They cause all manner of mischief in trying to understand trading patterns by executives, and keep in mind that shares purchased by close family members are attributed to the executive whether the executive has any legal claim to the shares or not. |
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Post by matt on Jun 10, 2020 9:31:24 GMT -5
Conclusion: The current analyses across 4 unique studies support the titration of individual patients to TI doses that are approximately 1.3 - 2.5x those of their comparable SC analog insulin doses. These data show that greater “unit doses” of TI should be used to achieve glycemic control in T1D and thus, insulins should be dosed based on glycemic responses rather than “insulin units.” Source: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-PThis second poster is the important poster of the two. It is the beginning of the work to get dosing on the label changed which in turn will deliver better results to the patient and make Afrezza a better choice. I agree that getting the label changed is important to delivering efficacy. Will MNKD deliver more units for the same price, or will there be a comparable increase in pricing? Given that Afrezza is already the most expensive option in the market, bumping the price by any significant amount will be counterproductive. Which begs the question of what is the true incremental cost of Afrezza in various dosage forms. I would think that the cost of the insulin and FDKP particles would have to increase proportionately, but the other costs (inhaler, cartridge, packaging, overhead) could stay approximately the same. |
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Post by matt on Jun 10, 2020 7:52:25 GMT -5
Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-PSummary: The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range. Other benefits were seen as detailed further in the abstract. In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-PSummary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins. This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza. |
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Post by matt on Jun 9, 2020 11:53:38 GMT -5
Now, if the trial completion is January 2021, would the estimate for the first pediatric prescription sales be mid-2021? Will they also need to get insurance companies onboard for Peds, or will that be automatic, since insurance is approved for adults and now sales are approved for peds? Another thought ... will approval for peds expedite Afrezza SoC? Afrezza is not indicated for children so it cannot be sold for pediatric use until FDA grants a label change. Obviously the hope is that this pediatric trial will be sufficient evidence to get FDA consent to amend the label, but that is not guaranteed. Since this is a significant change to the label, the study results will undergo a significant review process. If data collection is done January 2021, figure up to a year to compile the results and statistical analysis, write up an amendment to the drug application, submit it, and have FDA approve the label change. I know that sounds like a lot of time, but there are a bunch of moving pieces in any trial and they all have to be completed before approval is granted. Insurance companies that already cover Afrezza will likely cover pediatric use as well, but keep in mind that few insurance companies cover Afrezza as a Tier 1 or 2 drug so that requires the physician to go through a pre-approval process, and many don't cover it at all. Pediatrics will be no different. SoC is an entirely different kettle of fish, and one that is even more complicated than insurance to solve. Changing clinical practice never happens quickly. |
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Post by matt on Jun 7, 2020 7:39:54 GMT -5
Agedhippie has it right; Liquida is going after the continuation patents. Press releases are not the forum where Liquida needs to state their case in detail; the PTO proceeding is where that happens. There will be lots of evidence heading toward the PTO examiners when the time comes.
Patent strategies that rely on a single core patent with lots of add-ons and continuations are inherently risky unless the core patent is rock solid. If the core patent has been invalided, as in this case, the whole house of cards can come tumbling down. UTHR can still conduct its business, they will just have competition in the market.
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Post by matt on Jun 7, 2020 7:29:05 GMT -5
Such differences in average selling price usually arise due to different product mix. When there are different package sizes with differing units of drug that can be one driver. Some patients are truly new and are trying out the titration package which is year again different. Finally, remember than Symphony simply regurgitates the retail sales data that they collect from the dispensing pharmacies, and some pharmacies have larger markups or different dispensing fees if a PBM is involved. I suspect the MNKD wholesale revenue tracks much closer to the total number of scripts then the retail figures, but that is not what Symphony reports.
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Post by matt on Jun 6, 2020 6:54:57 GMT -5
Liquida was ahead of UTHR on this point. You may not have noticed but Liquida filed an action with the PTO to invalidate some of the UTHR patents. If the PTO grants that request, that effectively ends the matter and Hatch-Waxman no longer applies. It was a very smart thing for Liquida to do because the PTO reviews patent matters much faster than the US District Court and, because they are technology experts, an appeal is much more likely to get a rational, fact-based decision. The devil is always in the detail so I don't know which company will prevail on the merits, but this will likely not take 30 months to settle.
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