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Post by agedhippie on Jan 15, 2024 10:02:53 GMT -5
Wow - I did not realize those little cartridges we put the insulin in are made of gold. And whats driving the $760; the plastic inhaler; plastic cartridge; insulin cost; FDKP cost; rent on the factory Tyvaso DPI is paying for; something else? ... First, that's TRx, not per box if you read the post. Second, those are all MNKD sourced numbers from their presentations and SEC filings. I have no idea of how the cost breaks down since that isn't reported but those are the numbers MNKD is reporting.
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Post by agedhippie on Jan 15, 2024 9:54:38 GMT -5
Does anyone know if the 150 million that MNKD received will it go directly to the bottom line? How will this money affect the fourth quarter conference call and beyond? Not according to Mike under GAAP rules. I think (and I am not an accountant) that the treatment is much the same as a loan, in this case paid off at 10% of the royalties. It cannot be exactly the same since it is date rather than amount limited.
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Post by agedhippie on Jan 14, 2024 19:58:57 GMT -5
OK, thanks. Thats what I expected. How about if you could buy direct from MNKD at 15% over cost? Would that help? Rumor has it thats the deal costplusdrugs offered. I don't know what cost is. Lets say about $40 a box. ... How about grants? Have these centers worked with non-profits to apply for grants to pay the co-pay? Well, since we know that the the profit margin on Afrezza runs around 53 to 57% lets call it 60% for simplicity. Looking at 2022 for simplicity since they broke out Afrezza there, combine that with the TRx numbers from the JPM conference presentation, and we have a cost per prescription of just over $1,900. With a profit margin of 60% that means that each prescription costs MNKD $760. I don't think your numbers work. Non-profits are not working to subsidize drug companies. The pattern for that is well established and followed by every other drug company - they eat the costs.
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Post by agedhippie on Jan 12, 2024 16:29:23 GMT -5
At the JP Morgan Healthcare Conference yesterday, slide 6 said that Inhale-1 "interim analysis met DSMB expectations on trial size and safety." So at least there are no delays or problems related to that. I will translate that; so many people haven't dropped out that it has compromised the results, and nobody has died (literally!) The interim analysis is there to ensure that it is ethical to carry on with the trial.
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Post by agedhippie on Jan 12, 2024 13:45:22 GMT -5
With PED approval looking like April of 2025, at the earliest) MNKD will take another nap I'm sorry to say. So many struggles and our lenders shorting the stock every chance they get, what can MNKD possibly do? It seemed the Morgan Stanley thingy was only attended by 2 or 3 actual humans. The applause was obviously only a couple of folks. So disappointing. One of the best serial startup CEOs I knew said that success is about remaining in business until you get your lucky break - in this case that was Tyvaso DPI
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Post by agedhippie on Jan 12, 2024 13:31:06 GMT -5
There was also the case of Sanofi bringing in a new executive who was fresh off of the Exubera experience, just saying that may have had something to do with it also. I can easily see that. In any internal debate his position is going to be that it couldn't be done with Exubera so why should Afrezza be any different if the premise is selling on "no needles" - prejudice won.
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Post by agedhippie on Jan 12, 2024 11:47:25 GMT -5
... Mike C, the management team and the board of directors never expected the medical community (including BIG PHARMA) to be so determined to marginalize Afrezza. Thus, the pivot to drugs in the pipeline that have viability, limited competitors and will generate boatloads of money. ... If they expected to simply launch and everyone would rush to adopt it they were being extremely naive. Sanofi was probably the best BP partner since their RAA, Apidra, was a distant third in the RAA race and they would happily cannibalize it's sales for a blockbuster. What happened though was that nobody knew how to dose it, the strength conversion on the label was misleading, and almost nobody cared about it's launch USP (no needles.) Sanofi hit a second block which was insurance this was entirely predictable since it had happened to them before with Apidra. A bit of history; back around 2012 you could get your insurance would cover pretty much all insulins equally, and then Lilly did a deal to bundle their drugs which meant that overnight you could only get Humalog from most insurers. Subsequently Novo Nordisk and Lilly have used bundling to get exclusivity on insulin - whether you get Novolog or Humalog depends entirely on your PBM (this was deeply annoying as I find Novolog better lost it when that deal went through.) Having seen Sanofi, one of them, fail the PBMs couldn't care less about Afrezza since Mannkind has never addressed the block that stopped Sanofi, chiefly the lack of a data driven compelling case to convince doctors and compel coverage. Afrezza's sales are literally less than the weekly fluctuations of the major insulins - that's not what a threat! I entirely agree with your last sentence, and Mike stated this in the Morgan Stanley conference; the pivot to orphan drugs opens the way to low competition/high value markets. Once that is in place, and that means completing phase 3 trials, the share price will start to rise driven by those drugs. Absent that I think the stock is range bound since the market thinks it has a handle on what the Tyvaso DPI sales will look like into the future, and the best that pediatric approval is likely to do is double the Afrezza market based on MNKD's own slides from the JPM conference.
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Post by agedhippie on Jan 12, 2024 11:20:30 GMT -5
Wouldn't Midcap make even more money if mnkd stock price went up a lot? Are they shorting because the price was already low, or is the price low because they were shorting? Shorting isn't the problem, MidCap could short this regardless because the conversion price is far higher than the current price. The Foundation could short because their strike price is a long way below the current price. The far bigger problem is the fact that the debt is convertible which introduces the risk of dilution. As long as that possibility exists this creates an overhang and the share price will be reduced to account for the possibility of a flood of extra shares diluting the EPS. The degree to which the share price is reduced depends on the probability of the conversion being exercised - think of it like option pricing. Having said that, if MidCap wanted to exercise their conversion rights they may well short in the run up to the conversion in order to lock in a sale price as once they exercise their option the share price will drop and they want to have sold before that happens.
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Post by agedhippie on Jan 12, 2024 11:03:58 GMT -5
There is a slide in there from Jewish National Health showing a drop out rate for Tyvaso DPI (between 50 and 60%). Doctors will move those patients on an alternative - nebulized Tyvaso or a different DPI. If DPI is a favored by the patient Yutrepia would be a logical alternative. Plus there are always new patients. If we use common sense and logic and assuming that the 1 center didn't do any fudging (i.e. how sick are the patients, was it their last option, etc, etc, etc...) based on the adverse events of the trials for Tyvaso DPI vs. Yutrepia, the outcome very likely would be the same drop out rate or most likely even worse for Yutrepia. I think it's very unlikely they were fudging the numbers because the peer review will have asked for the data before it was accepted for the conference. What they are reporting is their experience with a new delivery mechanism for an established treatment (trepostinil) as a data point for comparison with other centers. I wouldn't disagree that having failed on Tyvaso DPI they likely will fail on Yutrepia (and vice versa), but they will still try them on the alternative because maybe it will work for them. The preference would logically be to find a working DPI solution given the satisfaction rates over nebulized delivery in both Tyvaso DPI and Yutrepia trials.
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Post by agedhippie on Jan 11, 2024 18:50:15 GMT -5
There is a slide in there from Jewish National Health showing a drop out rate for Tyvaso DPI (between 50 and 60%). Doctors will move those patients on an alternative - nebulized Tyvaso or a different DPI. If DPI is a favored by the patient Yutrepia would be a logical alternative. Plus there are always new patients. 50-60% of what? Patients to whom Jewish National Health prescribed Tyvaso DPI.
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Post by agedhippie on Jan 11, 2024 17:48:51 GMT -5
Liquidia is saying their higher doses are tolerated better than tyvaso dpi Uthr saying liquidia needs 3.3x the dose bc it does not get as deep into lungs. Can we conclude liquidia doses are tolerated better bc less of it is getting to the lungs? We can conclude that drug companies will highlight their most favorable aspects when selling to investors
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Post by agedhippie on Jan 11, 2024 17:46:55 GMT -5
It feels like that. I wouldn't be surprised to see Q1 around 75% since I think Q2/23 was an outlier looking at the progression and I would expect Q1/24 to be back in step again. I'm sure this is already covered. By the time LQDA comes online, if UTHR/MNKD would have already achieved 85-90%, how can LQDA even break in and be profitable? Especially as it looks like MNKD is better than LQDA in all usecases.. There is a slide in there from Jewish National Health showing a drop out rate for Tyvaso DPI (between 50 and 60%). Doctors will move those patients on an alternative - nebulized Tyvaso or a different DPI. If DPI is a favored by the patient Yutrepia would be a logical alternative. Plus there are always new patients.
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Post by agedhippie on Jan 11, 2024 12:42:11 GMT -5
Drug companies have to be careful comparing themselves to other drugs directly unless there is trial data for the comparison (one arm was your drug, another arm was their drug). Tyvaso nebulizer provides a way for them both to bridge between Tyvaso DPI and Yutrepia since neither has been compared to the other but both have been compared to Tyvaso nebulized. The slides for anyone who wants them. Slide 6 is interesting because it shows the conversion rate from all the UTHR Tyvaso products to Tyvaso DPI (the slide is apparently from a UTHR investor presentation) www.liquidia.com/static-files/83cf40bb-70ba-4345-90ed-307e89e0bafbBallparking slide 6, Q323 Tyvaso DPI sales are about 65 - 70%? It feels like that. I wouldn't be surprised to see Q1 around 75% since I think Q2/23 was an outlier looking at the progression and I would expect Q1/24 to be back in step again.
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Post by agedhippie on Jan 11, 2024 11:33:53 GMT -5
Anyone listen to LQDA'S presentation today? I honestly couldn't follow any of their taking points. I believe they were comparing Yutrepia to Tyvaso nebulizer. Definitely falling short comparing to Tyvaso DPI. Drug companies have to be careful comparing themselves to other drugs directly unless there is trial data for the comparison (one arm was your drug, another arm was their drug). Tyvaso nebulizer provides a way for them both to bridge between Tyvaso DPI and Yutrepia since neither has been compared to the other but both have been compared to Tyvaso nebulized. The slides for anyone who wants them. Slide 6 is interesting because it shows the conversion rate from all the UTHR Tyvaso products to Tyvaso DPI (the slide is apparently from a UTHR investor presentation) www.liquidia.com/static-files/83cf40bb-70ba-4345-90ed-307e89e0bafb
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Post by agedhippie on Jan 10, 2024 19:23:37 GMT -5
... Personally for me it’s FOMO. If something happens to shoot MNKD up to $4 (or whatever price we wanna set as a GTC), my thought is something “big” might’ve caused it and it’ll run much higher. ... That is the story of all my investing! Ask me why I didn't sell AMZN at the COVID peak...
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