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Post by agedhippie on Aug 23, 2023 21:42:27 GMT -5
Thank you Wyattdog! And thank you MannKind for paying your employees with stock that costs us next to nothing! ;-) It is you paying the employees, not Mannkind. That's why these schemes are so popular with companies - it moves the cost from them to the shareholders
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Post by agedhippie on Aug 23, 2023 13:00:57 GMT -5
Well said. Mango mentioned what I was going to counter agedhippie with. Mike (or at least MannKind management) decided to prioritize the development and Phase 1 trial of treprostinil on TechnoSphere which we now call United Therapeutic’s Tyvaso DPI. That was strategic and paid off and is paying off in a big way. Look at the timelines between LQDA phase 3 trial, and the MNKD phase 1 trial. That feels like this was driven by UTHR who suddenly needed a counter for Yutrepia (they had just listed it in their 10K as a business risk for the first time). The original work on TreT dates back to 2016 and predates Mike becoming CEO. Then in the start of 2018 there is a sudden flurry of activity following the announcement of the LQDA phase 3 trial. I think mnholden deserves Kudos for his prediction in response to pantaloon thought that a BP may be interested: I think that you are correct that there could be a partner interested in collaborating with MannKind on the development of TreT. As Castagna pointed out, Trepostinil(TS) comes with a relatively low-cost pathway to NDA in 2020. It could be sooner if some partner with deeper pockets than MannKind hooks up.mnkd.proboards.com/post/137270
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Post by agedhippie on Aug 23, 2023 9:59:54 GMT -5
What Mike did was what any business advisor would tell you to do. If you are running out of money to operate your choices are sell assets or borrow money. There was no capacity for further borrowing, the physical assets were already mortgaged, the only remaining asset was the stock so Mike did the obvious and expanding and selling off the float. This is really 101 stuff and not the work of a genius CEO.
In my view what saved MNKD was Martine. Until that time Mike was attempting (and failing) to relaunch Afrezza, dipping toes in the water with some drugs but lacking the funds to follow through, and keeping the business afloat by diluting the shareholders - it wasn't Mike that saved the company it was you long term shareholders! Oddly, it was also the traders because without the volume that there was nobody would have bought the share placements. Volume meant that there was liquidity and you could get in and out of a position. This was pretty awful for investors, you keep getting your stock devalued, but it kept the company afloat.
TLDR? Mike is a pretty average CEO who got a lucky break. Although as a CEO I knew once said, success is remaining in business until the lucky break that lets the company take off.
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Post by agedhippie on Aug 22, 2023 16:50:38 GMT -5
Can someone look up mnkd's share price before DPI approval and compare it to what it is now? After receiving XX (80?) million with the collaboration how is the SP lower now than pre-approval? Because you had the run-up when the development was completed and the approval paper work was completed (and UTHR paid the development complete milestone.) With the right ground work approval is a formality and you don't get rerated for that. UTHR was clear on the expected impact and the market has priced that in. The market is the prime example of "what have you done for me lately?" with all past achievements ignored.
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Post by agedhippie on Aug 22, 2023 16:36:11 GMT -5
... I agree that the future has never looked brighter, but one has to wonder how many quarters of positive profits the company needs to report before the rest of the street takes notice? At this point, I sense that the company needs to hit break even with the diabetes products, continued improved sales with Tyvaso DPI, and (IMO) a partnership on another molecule to really take off.^This. Until there a couple more partners the market is going to see MNKD as one of UTHR's suppliers rather than a delivery product vendor (with one customer it's a point solution, with several it's a product and strategic) The other thing is that they are going to start asking about strategic direction. Is MNKD a company selling drugs like Afrezza and the pipeline drugs, or is it a company selling Technosphere to package 3rd party drugs? Keeping things simple helps with the Street.
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Post by agedhippie on Aug 22, 2023 11:26:21 GMT -5
... We are constantly reminded that the Short Interest Rate (SIR) on MNKD is "normal" although Investopedia and others conversly describe an SIR of >10% as "fairly high". The current days-to-cover is >22, the most in the last year. powercycletrading.com described days-to-cover above 10 as indicating "extreme pessimism". So why aren't analysts viewing MNKD with "extreme pessimism"? Instead, analyst coverage has increased over the last year and the price targets increased. What should we think about these juxtaposed outlooks and data? The reported short numbers are rather opaque, but if the shorts are real the loan rate will move. If the report says shorting is high and the rate is unmoved everyone shrugs and moves on. Persistent elevated loan rates are what worries analysts and we don't see those.
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Post by agedhippie on Aug 22, 2023 10:21:37 GMT -5
from page 54 and 55 of liquida's form 10-q ● Tyvaso DPI, licensed from MannKind by United Therapeutics, is a dry-powder formulation of treprostinil that was approved for the treatment of PAH and PH-ILD in the United States in May 2022. There is a 54 Table of Contents possibility that the FDA could grant three years of market exclusivity to Tyvaso DPI as an inhaled dry-powder formulation of treprostinil that could delay the final approval of YUTREPIA until said exclusivity expires. That is from the Risks section of the 10Q which is a "kitchen sink" list of all risks, no matter how improbable, as disclosure provides a defense. This particular risk is only realized if UTHR wins the pending patent lawsuit which seems unlikely (he says tempting fate). Also from the 10Q: The FDA also confirmed that the clinical data in the NDA would support our pursuit of an amendment to our NDA to treat patients with pulmonary hypertension and interstitial lung disease (PH-ILD) upon the expiration of regulatory exclusivity in March 2024. We filed an amendment to our NDA to include PH-ILD as a labelled indication on July 24, 2023.
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Post by agedhippie on Aug 22, 2023 10:09:16 GMT -5
Liquidia to Defend Product Access 'Aggressively' After United Therapeutics Secures New Treprostinil-Related Patent 11:52 AM ET, 08/21/2023 - MT Newswires 11:52 AM EDT, 08/21/2023 (MT Newswires) -- Liquidia (LQDA) said in a regulatory filing Monday it is evaluating claims covered in the patent recently awarded to United Therapeutics (UTHR) related to the manufacture of treprostinil salts, indicated for the treatment of pulmonary arterial hypertension. The new patent "belongs to the same patent family" of three patents that were subject to a previous lawsuit and covers the same basic method of manufacturing treprostinil, Liquidia said. Liquidia plans "to aggressively defend the ability of patients to access the company's products," according to the filing. United Therapeutics didn't immediately respond to a request for comment by MT Newswires. Liquidia shares fell 1.7% in recent Monday trading, while United Therapeutics shares dropped.0.4%. Price: 6.84, Change: -0.12, Percent Change: -1.72 The patent is really about UTHR trying to narrow the '393 patent to the point where it was defensible. Their issue was that the '393 patent was overbroad and there was a different production method (Phares) that produced the same result which was partly why UTHR lost the IPR. This patent narrows the scope in exchange for protecting their explicit process. I feel the LQDA response was them trying to get ahead of a perception that this would impact their timelines (which I don't believe it will.) There are already a lot of companies producing generic treprostnil including some of the very large generics pharmas.
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Post by agedhippie on Aug 22, 2023 8:52:38 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling. On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.) The bottom line is that the launch remains on target for mid-2024. So, what is left of these patent suits? Launch still remains for mid-2024? The only remaining legal action is UTHR appealing against the US Patent Office decision to revoke their patent. Once they lose that (95+% probability) the FDA will approve Yutrepia and it can be launched. The timelines for that are late this year or early next year depending on whether the court issues and oral or written judgement. There are claims they will launched early next year, but I think around June 2024 is far more likely. There is another complication for LQDA which is that UTHR has exclusivity for PH-ILD until March 2024 from the FDA so launching before that. even if they could, would be confusing.
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Post by agedhippie on Aug 19, 2023 10:37:03 GMT -5
What I saw was several afrezza products listed with many other drugs which comprised what I thought was the bid package. My personal non-Medicare experience has been if the RFP includes it as a "shall" or "must" the vendor needs to include it in their offer. What happens during negotiations is another story. ... That definitely sounds like the FRF and is a list of all drugs Medicare will cover. The Medicare bid package never specifies actual drugs and instead requires ("must") coverage for each therapeutic class in the USP-NF (a slight oversimplification; the insurer can use their own class system but CMS make your life difficult if you do so everyone uses the USP-NF.) A class is defined by it's therapeutic use so Insulin, Rapid Acting includes both Afrezza and the RAA insulins. TLDR; Medicare will not require insurers to include Afrezza provided they have at least two RAA insulins in their bid package.
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Post by agedhippie on Aug 18, 2023 20:06:07 GMT -5
Aged - are you going to be OK if in fact when open enrolled starts in October we see afrezza being covered? There is that chance even though you keep insisting its not happening. Mike did hedge for 2025 but we will see. It was in the spreadsheet I saw in the original bid package although things could change. If what you are saying is correct and CMS "sets the low bar" then I am getting a little concerned for you. Then again I wonder how many drugs not included in the bid package are being added as "perks". Perks like "silver sneakers" I understand the selling point. Something like afrezza could get real expensive fast unless Uncle Sam is footing the bill. Afrezza is already covered by Medicare and covered by some insurers. If what you are talking about is universal coverage, yes I would be surprised but also perfectly fine with it - I believe diabetics should have choice. I am definitely correct that CMS sets the low bar - they set the minimum requirements for a formulary I suspect the spreadsheet you saw was the Formulary Reference File. That is a list of every drug that Medicare has approved, not a list of every drug that the insurer must cover. The FRF exists so there is a common taxonomy with the insurers, and for that reason Afrezza has been on it for a few years (it's a Medicare approved drug.)
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Post by agedhippie on Aug 18, 2023 9:13:42 GMT -5
Wonder if pediatric approval will require pre-auth? If not, it would make the chess game more interesting and should work to Mannkind's favor. This will vary from insurer to insurer depending on their formulary. I would expect their pre-auth policy for kids will track whatever their policy, pre-auth required or not, is for adults.
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Post by agedhippie on Aug 18, 2023 8:21:59 GMT -5
If I remember correctly the IRA originally had form "inhaled" included in the language but the last draft removed it and turned the responsibly back to CMS. So while form "inhaled" is not legally required it gave CMS the responsibility. In the bid packages which went out for 2023 in April of 2022 afrezza was not included for bid. If I go to Medicare.gov and select afrezza the below banner is included even though its not on any 2023 coverage. IMPORTANT! New insulin benefit: Started January 1, 2023 $35 cap for a one-month supply of each Medicare Part D-covered insulin This new $35 cap may not be reflected when you compare 2023 plans In the 2024 bid packages which went out in April of 2023 I am pretty sure I saw afrezza included. Its not about what the insurer "are compelled to sell". Its about what CMS is going to pay for and what they asked for during the bid process. At this point we know 3 things. First is it was not included for 2023. Second, to get around this CMS leveraged the pre auth process which allows the insurers to get paid. Third is we are two months away from the public availability of what CMS accepted for 2024 and will see on Medcare.gov what insurers if any provide afrezza coverage without pre auths. The references to inhaled insulin was a call out to the change in the IRS tax code that bought inhaled insulin into scope for high co-pay plans. It was not a requirement to provide inhaled insulin, but to avoid people using it being taxed for buying it rather than RAA. The CMS sets the low bar for the formularies. Insurers must meet or exceed that bar. They are compelled to provide that minimum. The idea that CMS used pre-auth steps as a way of paying insurers Afrezza is wrong. In the current (2023) formulary the insurer is at liberty to offer Afrezza with or without pre-auth and CMS will pay. The issue for Afrezza is that it's a lot more expensive than RAA and insurers don't want that eating into their profits so most put pre-auths on it. If anything pre-auths will become more common because insulin is $35 whether it's in the preferred or non-preferred section of an insurers formulary. This is assuming they keep Afrezza in the formulary and don't just drop it to avoid having to cover it at the lower rate and reduce the number of items with pre-authorization (which looks good to CMS).
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Post by agedhippie on Aug 16, 2023 8:14:36 GMT -5
It's a difficult question from what I have seen. Often there is very intense period while the treatment is set up, adjusted, readjusted, and so on until they become stable. Once it's set up though patients tend to drift away until something changes and they are no-longer stable. When a change happens though they will come back for more help. This can give the illusion of losing patients whereas what's really happening is that they still have the relationship, but there is no immediate need for contact.
That's my Type 1 view, Type 2 may well be different. YMMV.
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Post by agedhippie on Aug 14, 2023 19:17:26 GMT -5
... What Pfizer has told us is removing the shot in the diet market opens a $90B market. Is Pfizer correct? I think they are and that's why I think we see "Ozempic Shaming". Aged argues removing the shot will make no difference. For the diet market I think removing the shot is huge and a brand new tiktoc campaign. Now that Mike said last Monday we have some resources for a few more pilots I would like him to do the glp1/afrezza and Victoza DPI pilot. Of course I would have liked to see these last year before the money was spent on V-Go. As far as 101,201, 301 and 501 these pilots should have zero impact on them moving forward. This is not a zero sum game. Then again the IPF market potential is about $4B for nintedanib and not $90B. If you actually read the transcript of the call what Pfizer told us was that the entire GLP-1 market will be worth $90B. He expects the the oral market to be a maximum of $30B of which Pfizer wants a third, and by oral he is referring to pills. There is no reason for Pfizer to be interested in inhaled GLP-1 as they already have a pill version.
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