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Post by ktim on May 8, 2024 14:16:25 GMT -5
Thinking about Technosphere Insulin (Afrezza) combined with MannKind’s inhaler. Afrezza remains the safest insulin on the market. It’s the only prandial that matches physiologic insulin. Not just that, it’s the inhaler that is the other half of this equation that allows for this unique physiologic mimicry. The monomeric Technosphere insulin mimics intra-arterial administration, which is why it’s so damn fast. But, if it weren’t for the unique MannKind inhaler there would a big problem. The MannKind inhaler is expertly engineered to allow for slow, smooth moving particles across the anatomical airways into the deep lung with minimal deposition on the back of the throat and minimal patient effort. It’s the combination of the inhaler and Technosphere formulation that makes the MannKind DPI products so damn good. Afrezza comes with NO RISK of localized insulin-derived amyloidosis, lipohypertrophy, weight gain, pain and needle phobia. It has a SIGNIFICANTLY REDUCED RISK of hypo and hyper glycemic associated events. It’s a great product. Really? Why hasn't anyone been talking about how good Afrezza is here on Proboards. This is all new news to me  |
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Post by ktim on May 8, 2024 14:33:49 GMT -5
Coming back to the title of the thread I still believe Afrezza will be our gold mine and will be the main index of our technosfere pipeline... since when MNKD restarted by its own the sales of the drug every year we had gross sales and net rev increasing even with all selling problems related.... every year 15/25% INCREASE except only 2020 covid year.... Now we have a niche drug selling 120m+$ gross with 70m+$ rev not peanuts at all. Sure already sustainable and increasing. With ADA and studies on going even if q1 will be not stellar (except 2023 q1 has been always lower then q4) I am sure 2024 will be minimum another 20/30% increase..... good luck guys not only for today call but mainly for our near future.... Though a lot of Afrezza rev growth over the years has been in increasing $ per prescription not number of prescriptions. Peds approval should get some real patient number growth going. MNKD management is projecting Afrezza rev to roughly quadruple from 2023 to around $400M by 2032. Given that Clofazimine isn't technosphere based, Afrezza will be significant portion of tecnosphere revenue... though seemingly dropping to less than half technosphere rev for awhile to Tyvaso, the Afrezza growth seems to then overtake Tyvaso again 2028 or 2029. However, overall Affrezza revenue looks to be only about 25% of MNKD rev in 2032, though how much of the remainder of the rev will be technosphere is yet to be known. Though really when it comes to the technosphere platform, Tyvaso is going to be way outselling Afrezza because roughtly equivalent revenue to MNKD means Tyvaso will be outselling Afrezza 10 to 1. |
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Post by sayhey24 on May 8, 2024 18:35:50 GMT -5
Coming back to the title of the thread I still believe Afrezza will be our gold mine and will be the main index of our technosfere pipeline... since when MNKD restarted by its own the sales of the drug every year we had gross sales and net rev increasing even with all selling problems related.... every year 15/25% INCREASE except only 2020 covid year.... Now we have a niche drug selling 120m+$ gross with 70m+$ rev not peanuts at all. Sure already sustainable and increasing. With ADA and studies on going even if q1 will be not stellar (except 2023 q1 has been always lower then q4) I am sure 2024 will be minimum another 20/30% increase..... good luck guys not only for today call but mainly for our near future.... Though a lot of Afrezza rev growth over the years has been in increasing $ per prescription not number of prescriptions. Peds approval should get some real patient number growth going. MNKD management is projecting Afrezza rev to roughly quadruple from 2023 to around $400M by 2032. Given that Clofazimine isn't technosphere based, Afrezza will be significant portion of tecnosphere revenue... though seemingly dropping to less than half technosphere rev for awhile to Tyvaso, the Afrezza growth seems to then overtake Tyvaso again 2028 or 2029. However, overall Affrezza revenue looks to be only about 25% of MNKD rev in 2032, though how much of the remainder of the rev will be technosphere is yet to be known. Though really when it comes to the technosphere platform, Tyvaso is going to be way outselling Afrezza because roughtly equivalent revenue to MNKD means Tyvaso will be outselling Afrezza 10 to 1. Tyvaso DPI will only out sell afrezza until the cost issue is solved. Once afrezza has insurance coverage or they decide to reduce the price, afrezza will make Tyvaso DPI look like small potatoes. Until then, its paying the bills and thats a great thing because the 6 month delay we heard about today for the kids was not great news but not surprising. |
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Post by prcgorman2 on May 9, 2024 6:42:11 GMT -5
The “6 month delay” isn’t a delay until it is. FDA wants 6 more months. MNKD wants 6 months less. Mike said they have a good working relationship with the FDA (which I think the orphan designation and Fast Track approval for Clofazimine proves is true), and that they will seek approval after 6 months but would not jeopardize that good relationship in an arguement over 6 months. Meaningful at-scale trials for Afrezza have been delayed most of a decade between Oliver Brandicoot scuttling the Sanofi worldwide marketing agreement and COVID, another 6 months will be par for the course.
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Post by mango on May 9, 2024 11:21:21 GMT -5
If I was Mike I would be starting a safety clinical trial against RAAs. Let’s go ahead and get the safety superiority designation against RAAs. No risk of insulin-derived amyloidosis, lipohypertrophy, weight gain, pain, needle phobia, inconvenience, and so on. Compare prevalence in hypoglycemia and post prandial hyperglycemia. All patients wear CGMs. It would be a clinical trial like no other, assessing injection sites before and at the end of the trial for insulin-amyloid prevalence from RRA usage and lipohypertrophy, this of course would involve knowledgeable dermatologists and endos in this field of research which is small. Requires special testing and is invasive.
While we are at it, let’s do a large scale trial against all the oral antiglycemic agents for TIR superiority. Afrezza will blow this study out of the water.
Go ahead and add on the gestational study that Mike has been talking about and we have a hell of a 3 studies to work with.
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Post by agedhippie on May 9, 2024 13:28:27 GMT -5
If I was Mike I would be starting a safety clinical trial against RAAs. Let’s go ahead and get the safety superiority designation against RAAs. No risk of insulin-derived amyloidosis, lipohypertrophy, weight gain, pain, needle phobia, inconvenience, and so on. Compare prevalence in hypoglycemia and post prandial hyperglycemia. All patients wear CGMs. It would be a clinical trial like no other, assessing injection sites before and at the end of the trial for insulin-amyloid prevalence from RRA usage and lipohypertrophy, this of course would involve knowledgeable dermatologists and endos in this field of research which is small. Requires special testing and is invasive. While we are at it, let’s do a large scale trial against all the oral antiglycemic agents for TIR superiority. Afrezza will blow this study out of the water. Go ahead and add on the gestational study that Mike has been talking about and we have a hell of a 3 studies to work with. The first two are not going to happen. The outcomes you are looking at take years to decades to develop, needle phobia is a tiny group, inconvenience exists with both options, and hypos are better but marginally so for Type 1. For the second trial they would still stick with HbA1c rather than TIR because the TIR outcomes data is not as well developed (but it's getting there). The gestational study would be on the same scale as the pediatric trial since it is a class of patient. I said back in 2017 that was the trial to do, and I still do. This is an easy win. |
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Post by ktim on May 9, 2024 14:52:42 GMT -5
Though a lot of Afrezza rev growth over the years has been in increasing $ per prescription not number of prescriptions. Peds approval should get some real patient number growth going. MNKD management is projecting Afrezza rev to roughly quadruple from 2023 to around $400M by 2032. Given that Clofazimine isn't technosphere based, Afrezza will be significant portion of tecnosphere revenue... though seemingly dropping to less than half technosphere rev for awhile to Tyvaso, the Afrezza growth seems to then overtake Tyvaso again 2028 or 2029. However, overall Affrezza revenue looks to be only about 25% of MNKD rev in 2032, though how much of the remainder of the rev will be technosphere is yet to be known. Though really when it comes to the technosphere platform, Tyvaso is going to be way outselling Afrezza because roughtly equivalent revenue to MNKD means Tyvaso will be outselling Afrezza 10 to 1. Tyvaso DPI will only out sell afrezza until the cost issue is solved. Once afrezza has insurance coverage or they decide to reduce the price, afrezza will make Tyvaso DPI look like small potatoes. Until then, its paying the bills and thats a great thing because the 6 month delay we heard about today for the kids was not great news but not surprising. I'm just talking about reality and what management plans to do. |
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Post by prcgorman2 on May 9, 2024 15:21:01 GMT -5
I couldn't guess the math behind the assumptions of 10:1 ratio of Tyvaso(DPI):Afrezza sales. My apologies if that should have been obvious to people who are not math challenged. Can you walk me through it?
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Post by ktim on May 9, 2024 15:55:53 GMT -5
I couldn't guess the math behind the assumptions of 10:1 ratio of Tyvaso(DPI):Afrezza sales. My apologies if that should have been obvious to people who are not math challenged. Can you walk me through it? If you look at projections for revenue given sometime late last year (I believe that was when) it shows the rev from Tyvaso royalties roughly equivalent to Afrezza rev. Since we're only getting 10% of Tyvaso revenue that would mean the revenue for the product Tyvaso DPI would be 10x that of Afrezza product revenue. So when it comes to measuring success of technosphere as a platform, Tyvaso is expected to be the big success for the foreseeable future, since our next candidate isn't DPI. That mostly is irrelevant point. I personally have given up hope that technosphere is somehow going to become a sought after platform simply as a delivery mechanism for other companies' active molecules. Not impossible, but certainly not something I'm expecting. Though perhaps one of our proboards members might consider starting a company to license technosphere and use it for delivery of Saxendra, which apparently is almost assured to be a blockbuster. |
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Post by prcgorman2 on May 9, 2024 16:08:46 GMT -5
Ah, ok, thanks. Mike didn't say anything about a TS version of Clofazimine on this last call, but he has said that was under consideration in the past. I'm ambivalent. Clofazimine DPI would need to provide some cost/performance benefit over the liquid version they're testing to accelerate the timeline to get to market. I'm excited about the product they're testing in the upcoming Ph3 trial in terms of how much more likely it is to help as compared to the oral version on the market today. And getting some (major?) portion of a $3.7B market is definitely going to help the debt-free bottom-line.
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Post by ktim on May 9, 2024 16:56:28 GMT -5
Ah, ok, thanks. Mike didn't say anything about a TS version of Clofazimine on this last call, but he has said that was under consideration in the past. I'm ambivalent. Clofazimine DPI would need to provide some cost/performance benefit over the liquid version they're testing to accelerate the timeline to get to market. I'm excited about the product they're testing in the upcoming Ph3 trial in terms of how much more likely it is to help as compared to the oral version on the market today. And getting some (major?) portion of a $3.7B market is definitely going to help the debt-free bottom-line. I don't think Clofazimine is a multiple times a day inhalation, so I really don't see much of an advantage to a technosphere version since one isn't having to worry about carrying a nebulizer around. Seems questionable whether it would ever make sense to spend the money on DPI version. |
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Post by agedhippie on May 10, 2024 8:19:58 GMT -5
Ah, ok, thanks. Mike didn't say anything about a TS version of Clofazimine on this last call, but he has said that was under consideration in the past. I'm ambivalent. Clofazimine DPI would need to provide some cost/performance benefit over the liquid version they're testing to accelerate the timeline to get to market. I'm excited about the product they're testing in the upcoming Ph3 trial in terms of how much more likely it is to help as compared to the oral version on the market today. And getting some (major?) portion of a $3.7B market is definitely going to help the debt-free bottom-line. I don't think Clofazimine is a multiple times a day inhalation, so I really don't see much of an advantage to a technosphere version since one isn't having to worry about carrying a nebulizer around. Seems questionable whether it would ever make sense to spend the money on DPI version. They have a developed product on it's way to FDA approval and a relatively small but lucrative market. There isn't really a financial reason to put it on DPI. They would take the financial hit of doing the work and of running a conversion trial like UTHR did. |
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Post by sayhey24 on May 10, 2024 15:31:08 GMT -5
I don't think Clofazimine is a multiple times a day inhalation, so I really don't see much of an advantage to a technosphere version since one isn't having to worry about carrying a nebulizer around. Seems questionable whether it would ever make sense to spend the money on DPI version. They have a developed product on it's way to FDA approval and a relatively small but lucrative market. There isn't really a financial reason to put it on DPI. They would take the financial hit of doing the work and of running a conversion trial like UTHR did. Mike said a call ago they have already put it on TS and have determined dosing. It sounded like it took some effort. When the fire hit it set them back 6 months. At this point if we really thought Technosphere would make a better product maybe it would in the long run be better to just do the trial with Technosphere. At this point I say don't spend any more time or money and just go with what they have. If it pans out they can follow the UTHR Tyvaso model and do the conversion trial. Personally, I would rather see the focus on afrezza getting the gestational study done and the afrezza/glp1 study done. |
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Post by sayhey24 on May 10, 2024 15:40:23 GMT -5
I couldn't guess the math behind the assumptions of 10:1 ratio of Tyvaso(DPI):Afrezza sales. My apologies if that should have been obvious to people who are not math challenged. Can you walk me through it? If you look at projections for revenue given sometime late last year (I believe that was when) it shows the rev from Tyvaso royalties roughly equivalent to Afrezza rev. Since we're only getting 10% of Tyvaso revenue that would mean the revenue for the product Tyvaso DPI would be 10x that of Afrezza product revenue. So when it comes to measuring success of technosphere as a platform, Tyvaso is expected to be the big success for the foreseeable future, since our next candidate isn't DPI. That mostly is irrelevant point. I personally have given up hope that technosphere is somehow going to become a sought after platform simply as a delivery mechanism for other companies' active molecules. Not impossible, but certainly not something I'm expecting. Though perhaps one of our proboards members might consider starting a company to license technosphere and use it for delivery of Saxendra, which apparently is almost assured to be a blockbuster. Now you are really making some sense - Saxenda DPI. I like it! However, the rumor I heard is MNKD is not interested in licensing the GLP1 patent. I hope I am wrong but I don't think so. Who knows maybe they are still thinking about it. It is as you say a potential blockbuster but with Mark Cuban probably a super blockbuster. We know they spend a lot of time talking about things like the gestational study and the afrezza/glp1 study. Maybe they spend a lot of time thinking too. |
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limo
Researcher
Posts: 82
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Post by limo on May 21, 2024 2:28:45 GMT -5
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