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Post by agedhippie on Jul 27, 2024 18:14:39 GMT -5
...There needs to be 100% focus on getting insurance coverage for afrezza. MNKD-101, 201 and the rest are years away and at this point a pipe dream. Afrezza insurance needs to be 100% of the focus. Get afrezza insurance and we have $20pps+.... Easier said than done. Novo Nordisk and Eli Lilly own the GLP-1 market with some stunningly expensive, and hence very profitable for the PBMs, drugs. Why are insurers going to give up those juicy margins to make a huge loss selling Afrezza at $35 a month for all you can eat? Commercially, selling Afrezza would be a disaster for insurers, and reducing the price to where Afrezza is competitive would be a disaster for MNKD. You are going to have to compensate the PBMs for the margin they are losing on GLP-1 as well as making $35 per month prescriptions viable. |
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Post by sayhey24 on Jul 28, 2024 16:19:58 GMT -5
...There needs to be 100% focus on getting insurance coverage for afrezza. MNKD-101, 201 and the rest are years away and at this point a pipe dream. Afrezza insurance needs to be 100% of the focus. Get afrezza insurance and we have $20pps+.... Easier said than done. Novo Nordisk and Eli Lilly own the GLP-1 market with some stunningly expensive, and hence very profitable for the PBMs, drugs. Why are insurers going to give up those juicy margins to make a huge loss selling Afrezza at $35 a month for all you can eat? Commercially, selling Afrezza would be a disaster for insurers, and reducing the price to where Afrezza is competitive would be a disaster for MNKD. You are going to have to compensate the PBMs for the margin they are losing on GLP-1 as well as making $35 per month prescriptions viable. Because the kids trial is going to be outstanding and its the right thing to do for the kids. Mike needs 100% focus on insurance. |
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Post by agedhippie on Jul 28, 2024 16:25:23 GMT -5
Because the kids trial is going to be outstanding and its the right thing to do for the kids. Mike needs 100% focus on insurance. It's easy to say "be 100% focused on insurance", but without an action plan it's just wasting resources. What do you suggest he does that will get traction with the insurers and avoid this? |
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Post by sayhey24 on Jul 29, 2024 6:14:28 GMT -5
Because the kids trial is going to be outstanding and its the right thing to do for the kids. Mike needs 100% focus on insurance. It's easy to say "be 100% focused on insurance", but without an action plan it's just wasting resources. What do you suggest he does that will get traction with the insurers and avoid this? What I propose is Mike earns his salary. Thats what he is getting paid for. My job with MNKD is to invest and let my voice be heard. I don't know why it took Mike so long to identify the key to sales of afrezza is not hiring new sales reps but rather fix; the label; the SoC; and the cost. Since he does not want to reduce the $1200 price then he needs to get insurance. We get insurance and we are not a $6 stock. We are $20+. BTW - I see Hirsch is at ATTD talking about "pulmonary inhaled insulin". |
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Post by agedhippie on Jul 29, 2024 8:15:36 GMT -5
It's easy to say "be 100% focused on insurance", but without an action plan it's just wasting resources. What do you suggest he does that will get traction with the insurers and avoid this? What I propose is Mike earns his salary. Thats what he is getting paid for. My job with MNKD is to invest and let my voice be heard. ... So, no idea at all how he can achieve it, that's what I expected. I think it's far more productive for Mike to follow things where he can actually move the needle rather than chase rainbows. |
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Post by sayhey24 on Jul 29, 2024 9:53:50 GMT -5
What I propose is Mike earns his salary. Thats what he is getting paid for. My job with MNKD is to invest and let my voice be heard. ... So, no idea at all how he can achieve it, that's what I expected. I think it's far more productive for Mike to follow things where he can actually move the needle rather than chase rainbows. If selling afrezza is chasing rainbows then we have a real problem and Al Mann was a fool. I don't think thats the case. Mike's a big boy and he needs to put his big boy pants on. If he can't do his job maybe someone else can. Its taken years to get him up to speed. He now has the kids study reaching the finish line. He needs to get insurance so the kids can afford afrezza. For all I care he can put it on sale for 2 years and develop the patient base Bill from VDex suggested. How he reduces the cost, I really don't care as long has he gets it done for the kids. The fastest way is to run a sale and sell direct or cut a 2 year deal with Mark Cuban and let Mark do the selling. |
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Post by casualinvestor on Jul 29, 2024 11:13:08 GMT -5
For all I care he can put it on sale for 2 years and develop the patient base Bill from VDex suggested. How he reduces the cost, I really don't care as long has he gets it done for the kids. The fastest way is to run a sale and sell direct or cut a 2 year deal with Mark Cuban and let Mark do the selling. I don't think Mannkind can afford to reduce the cost of Afrezza significantly. And it not because of the $$ on the bottom line (halving the cost of Afrezza would lose $7.2M per quarter though, and I don't think even that cost reduction would make it attractive to insurers), it's about production. The idea that Afrezza could be sold at a loss for a while, gain a ton of prescriptions (lets say 10x), then raise prices a bit and become profitable through economies of scale probably won't work out. They can't make that much Afrezza right now. 10x is only likely with another, hopefully more cost effective, factory. Disclaimer: I have zero inside knowledge of Afrezza production, but the trouble they had with T-DPI production a year ago was a huge warning sign to me about ramping technosphere production. As a benchmark: UTHR is building a factory for $300-500M to make double the T-DPI output that Danbury has. A worrying gamble: If MNKD halves the price of Afrezza and somehow increases production/sales by 2x, then their losses per quarter would also increase, due to selling more product at a loss! So, can/should MNKD drop revenue significantly through lowering price, while spending significantly on CapEx to raise production (IE adding another Afrezza line)? I wouldn't touch that gamble right now. |
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Post by cretin11 on Jul 29, 2024 12:12:08 GMT -5
The profit/loss concerns with sayhey's strategy are legit. Doesn't mean it's a bad strategy but there would be that negative bottom line impact at least short term.
But as for production, shouldn't we be able to ramp up Afrezza production 10x or so without much problem? I don't have specific knowledge of production capacity, but recall many years ago when MC was hired with the primary task of commercializing Afrezza, he was suggesting large increases in TRx numbers (as we all were expecting) and it seemed production capacity was not anticipated to be a major obstacle. For historical reference, the week he was hired TRx was 379 (and our share price topped $10). We expected over 10K weekly TRx within a few years of his hire in March 2016, which would be about a 10X increase from where we are today assuming we are around 1000 TRx. It would be disappointing if even as low a number as 10K TRx would be problematic from a production standpoint. Of course it's a moot point today, but we all hope it isn't moot after peds.
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Post by sayhey24 on Jul 29, 2024 13:02:49 GMT -5
For all I care he can put it on sale for 2 years and develop the patient base Bill from VDex suggested. How he reduces the cost, I really don't care as long has he gets it done for the kids. The fastest way is to run a sale and sell direct or cut a 2 year deal with Mark Cuban and let Mark do the selling. I don't think Mannkind can afford to reduce the cost of Afrezza significantly. And it not because of the $$ on the bottom line (halving the cost of Afrezza would lose $7.2M per quarter though, and I don't think even that cost reduction would make it attractive to insurers), it's about production. The idea that Afrezza could be sold at a loss for a while, gain a ton of prescriptions (lets say 10x), then raise prices a bit and become profitable through economies of scale probably won't work out. They can't make that much Afrezza right now. 10x is only likely with another, hopefully more cost effective, factory. Disclaimer: I have zero inside knowledge of Afrezza production, but the trouble they had with T-DPI production a year ago was a huge warning sign to me about ramping technosphere production. As a benchmark: UTHR is building a factory for $300-500M to make double the T-DPI output that Danbury has. A worrying gamble: If MNKD halves the price of Afrezza and somehow increases production/sales by 2x, then their losses per quarter would also increase, due to selling more product at a loss! So, can/should MNKD drop revenue significantly through lowering price, while spending significantly on CapEx to raise production (IE adding another Afrezza line)? I wouldn't touch that gamble right now. Why not? Lets say they have 1500 script/wk. Half are pre-auths on Medicare and selling for $35. Tyvaso DPI is paying the factory costs and is making MNKD profitable. Not afrezza. I think we can't afford not to do something and soon. If Mike can get insurance, all the better but so far he has struck out. He was not even able to get Medicare without pre-auths for 2024. The goal is to develop a big enough market presence to change the SoC and allow the kids to afford it and get a big enough base forcing insurance coverage. At the same time we can start working with the Abbott and Dexcom on the T2 Medicare market and getting them to sell afrezza into the T2 Medicare market. Dexcom needs a new game plan and so does Abbott who was banking on icodec. We just wasted $20M on V-Go and now we are paying salaries of employees from another company. Heck we spent $6M on the "Seeing is Believing" campaign and I have no idea what was done. Nobody is paying half the cost of current afrezza. Amazon is selling a box of 8 for $800 www.amazon.com/s?k=afrezza+8+unit&crid=1C1UUD8H9RF9H&sprefix=afrezza%2Caps%2C134&ref=nb_sb_ss_pltr-sample-20_5_7 |
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Post by prcgorman2 on Jul 29, 2024 14:27:49 GMT -5
The profit/loss concerns with sayhey's strategy are legit. Doesn't mean it's a bad strategy but there would be that negative bottom line impact at least short term. But as for production, shouldn't we be able to ramp up Afrezza production 10x or so without much problem? I don't have specific knowledge of production capacity, but recall many years ago when MC was hired with the primary task of commercializing Afrezza, he was suggesting large increases in TRx numbers (as we all were expecting) and it seemed production capacity was not anticipated to be a major obstacle. For historical reference, the week he was hired TRx was 379 (and our share price topped $10). We expected over 10K weekly TRx within a few years of his hire in March 2016, which would be about a 10X increase from where we are today assuming we are around 1000 TRx. It would be disappointing if even as low a number as 10K TRx would be problematic from a production standpoint. Of course it's a moot point today, but we all hope it isn't moot after peds. I have production numbers in a spreadsheet from about 10 years ago (which might be a bit tricky to find actually) but the production capacity of a single line far outstripped MannKind's ability to sell Afrezza for lots of reasons, the #1 reason being not enough prescribers. Insurance coverage does not cause a doctor to write a prescription. Neither does the cost to the patient.
The Standard Of Care does usefully influence writing of prescriptions, and all that is needed is to convince the consortium of folks that determine the SoC that Afrezza should be first in line for use at mealtime.
The most influential method of getting prescriptions for Afrezza is proof that it is medically the best option for mealtime use. Much easier said than done. And, it is being worked on, but not to the exclusion of all else, and I am very glad of that.
In fact, if it weren't for the pipeline, MannKind might not still be here. For those who don't know (or with poor memories), Tyvaso DPI, the lifeblood of MannKind, began as a successful Phase 1 clinical trial of treprostinil on TechnoSphere which led to the deal with United Therapeutics and about a 4x to 5x increase in the MNKD share price from when Mike Castagna took over as CEO. Clofazimine, the FDA Fast Track orphan drug currently in a combined Phase 2/3 trial may contribute as much revenue as Tyvaso DPI. Nintedanib, the next pipeline candidate, may contribute significantly more revenue than Tyvaso DPI and Clofazimine combined.
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Post by anderson on Jul 29, 2024 15:24:36 GMT -5
Hmmm. It must be really frustrating to be "right" about everything and not be able to do anything about it. I wish you had put on your suit and tie 8 years ago and interviewed for the MNKD CEO position. Our stock would be at $100 right now. On a serious note, please show us where your $10 mm/25 people numbers are coming from? I see total lease expense running $1.3-1.4 mm a year, and that's for the entire Bedford, MA complex that includes the corporate offices, so rent expense for the lab would be less than the total. That would leave 25 people making $344,000 to come to your $10 mm number. Unlikely. Again, where are you getting your assumptions? Also, who said anything about iSPHERE replacing TS? And finally, I believe UTHR said they're spending $500 mm on the plant in NC to be used for Tyvaso DPI? Clearly THE BOARD made the decision to explore the potential of iSPHERE. They have a lot more information than we do. Well, you said it was a no cash deal. Now you see its going to be more than $1, a lot more. I assumed PhD Research Scientists made some decent money but maybe they don't. Let assume $150k plus benefits or about $200k. Maybe we got lucky and this is only going to cost $5M a year but probably more. More important it is a distraction from MNKD getting insurance coverage for afrezza. You asked - "who said anything about iSPHERE replacing TS" The PR "The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and INSULIN" I did make a leap on my own thinking Cipla started the discussions but why? Maybe Inhale-2? Maybe it was MNKD's way of a non-compete with afrezza but I would have added Glp1s. What I do know is building another factory will be expensive. MNKD for me is an investment I made because I believed Al Mann. To date it has been my worst investment but I still believe Al was correct and I still think $100pps is very doable. In fact many years ago I said the value of MNKD was 100x that of DXCM. I could be wrong but I am not giving up yet. Many years ago my first company I took public I had to put up with all the whiny investors. IMO, if you can keep your ventures private all the better. Eight years ago I was just starting another venture which has worked out really well and led to a number of private companies. Being MNKD's CEO was not something which would have interested me. I surely was not going to LA and Danbury is a mess and why would I want to put up with whiny investors? As part of the deal I get to spend a lot of time on the beach a bit south of where Biden will be hanging out. Why he came off the beach four years ago still makes no sense to me. It would have been like becoming MNKD's CEO for me. Nope, I got another surfboard for this season and I want to see it put to good use. This may not be all bad. They are researchers that have experience in dry powder inhale technology and Mike C has said a couple of time they are pretty maxed out in the research department. I would expect equipment is cheap and finding experienced scientist is a harder job. This gets people with experience and more lab space so that as MNKD has more cash they can start expanding the pipeline. |
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Post by sayhey24 on Jul 29, 2024 15:47:47 GMT -5
The profit/loss concerns with sayhey's strategy are legit. Doesn't mean it's a bad strategy but there would be that negative bottom line impact at least short term. But as for production, shouldn't we be able to ramp up Afrezza production 10x or so without much problem? I don't have specific knowledge of production capacity, but recall many years ago when MC was hired with the primary task of commercializing Afrezza, he was suggesting large increases in TRx numbers (as we all were expecting) and it seemed production capacity was not anticipated to be a major obstacle. For historical reference, the week he was hired TRx was 379 (and our share price topped $10). We expected over 10K weekly TRx within a few years of his hire in March 2016, which would be about a 10X increase from where we are today assuming we are around 1000 TRx. It would be disappointing if even as low a number as 10K TRx would be problematic from a production standpoint. Of course it's a moot point today, but we all hope it isn't moot after peds. I have production numbers in a spreadsheet from about 10 years ago (which might be a bit tricky to find actually) but the production capacity of a single line far outstripped MannKind's ability to sell Afrezza for lots of reasons, the #1 reason being not enough prescribers. Insurance coverage does not cause a doctor to write a prescription. Neither does the cost to the patient.
The Standard Of Care does usefully influence writing of prescriptions, and all that is needed is to convince the consortium of folks that determine the SoC that Afrezza should be first in line for use at mealtime.
The most influential method of getting prescriptions for Afrezza is proof that it is medically the best option for mealtime use. Much easier said than done. And, it is being worked on, but not to the exclusion of all else, and I am very glad of that.
In fact, if it weren't for the pipeline, MannKind might not still be here. For those who don't know (or with poor memories), Tyvaso DPI, the lifeblood of MannKind, began as a successful Phase 1 clinical trial of Treprostinil on TechnoSphere which led to the deal with United Therapeutics and about a 4x to 5x increase in the MNKD share price from when Mike Castagna took over as CEO. Clofazimine, the FDA Fast Track orphan drug currently in a combined Phase 2/3 trial may contribute as much revenue as Tyvaso DPI. Nintedanib, the next pipeline candidate, may contribute significantly more revenue than Tyvaso DPI and Clofazimine combined.
Lets start here - Insurance coverage does not cause a doctor to write a prescription. Neither does the cost to the patient. That is a true statement BUT a doctor is not going to write a subscription which is not going to be filled. If they doctor says to the patient - this is not covered by insurance and will cost you $1k a box and you may need 1 1/2 boxes a month are you willing to pay that $1500 or Ii can write you a script for an RAA and it will cost you $35 on Medicare - what do you think is going to happen? Again, this is a true statement - The Standard Of Care does usefully (usually) influence writing of prescriptions. However this is not - all that is needed is to convince the consortium of folks that determine the SoC that Afrezza should be first in line for use at mealtime. To "convince" is not an easy task. This "convincing" not only takes trial data but it also takes political sway. It requires MNKD to overcome the lobbying of Big Pharm and BP does not want afrezza disrupting their $100M market. Bill from VDex suggested a 50k user base is the number needed to overcome their lobbying. The UTHR story is much more complicated than just having Treprostinil in the pipeline. The relationship between Martine and Al Mann went back to MiniMed. Martine was well aware of what Al was doing with TS back in 1990. She was also well aware of the struggles MNKD was facing before and after Al's passing. Treprostinil was a targeted development with a targeted partner. The good news is TS won over PRINT and the partnership was signed and Martine saved MNKD. Maybe Clofazimine has a similar targeted partner. Maybe its UTHR again. I sure hope so but time will tell. If so I would have thought UTHR would have taken the lead on the non-DPI development but they have not. I hope we have a targeted partner but I don't think so. Maybe a better pipeline product would be with Teva who is now making generic Victoza. A Saxenda DPI solution with a target vendor of Teva might make more sense. Afrezza revenue once they have; the label fixed; the SoC fixed; and the cost (insurance) fixed will dwarf Tyvaso DPI, MNKD-101 and 201 combined. If Saxenda DPI works as well as Peter Richardson thought, it could very well dwarf afrezza revenue. |
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Post by ktim on Jul 29, 2024 16:38:19 GMT -5
Again, this is a true statement - The Standard Of Care does usefully (usually) influence writing of prescriptions. However this is not - all that is needed is to convince the consortium of folks that determine the SoC that Afrezza should be first in line for use at mealtime. To "convince" is not an easy task. This "convincing" not only takes trial data but it also takes political sway. It requires MNKD to overcome the lobbying of Big Pharm and BP does not want afrezza disrupting their $100M market. Bill from VDex suggested a 50k user base is the number needed to overcome their lobbying.Does Bill actually have experience working with the ADA SOC setting process, or is that merely his speculation? Seems they have spelled out criteria based on trial results and no indication that number of patients using a therapy is taken into account. Wonder how many patients VDex has on Afrezza. I assume they are targeting that portion of the patient population really wanting/willing to be especially attentive and trying to maximize results with a proactive approach. Hopefully at some point they would present some data on their results. It wouldn't be given the same weight as actual clinical trials, but could garner some attention. |
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Post by agedhippie on Jul 29, 2024 18:33:10 GMT -5
Again, this is a true statement - The Standard Of Care does usefully (usually) influence writing of prescriptions. However this is not - all that is needed is to convince the consortium of folks that determine the SoC that Afrezza should be first in line for use at mealtime. To "convince" is not an easy task. This "convincing" not only takes trial data but it also takes political sway. It requires MNKD to overcome the lobbying of Big Pharm and BP does not want afrezza disrupting their $100M market. Bill from VDex suggested a 50k user base is the number needed to overcome their lobbying.Does Bill actually have experience working with the ADA SOC setting process, or is that merely his speculation? Seems they have spelled out criteria based on trial results and no indication that number of patients using a therapy is taken into account. ... I don't know how Bill arrived at that number, but it is pretty close to 10% of Type 1 diabetics using RAA. The ADA is data driven when it comes to the SOC. They are crystal clear on how they reach their decisions: Methodology and Procedure. The approach is exclusively evidence approach except for the lowest grade which is KOL members of it's Professional Practice Committee ( Expert opinion E is a separate category for recommendations in which there is no evidence from clinical trials, clinical trials may be impractical, or there is conflicting evidence). In other words clear clinical trials trump KOL views. The relevant evidence classification table from the earlier link is here: ADA evidence-grading system for Standards of Care in Diabetes |
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Post by bones1026 on Jul 29, 2024 19:09:32 GMT -5
Does Bill actually have experience working with the ADA SOC setting process, or is that merely his speculation? Seems they have spelled out criteria based on trial results and no indication that number of patients using a therapy is taken into account. ... I don't know how Bill arrived at that number, but it is pretty close to 10% of Type 1 diabetics using RAA. The ADA is data driven when it comes to the SOC. They are crystal clear on how they reach their decisions: Methodology and Procedure. The approach is exclusively evidence approach except for the lowest grade which is KOL members of it's Professional Practice Committee ( Expert opinion E is a separate category for recommendations in which there is no evidence from clinical trials, clinical trials may be impractical, or there is conflicting evidence). In other words clear clinical trials trump KOL views. The relevant evidence classification table from the earlier link is here: ADA evidence-grading system for Standards of Care in DiabetesPlease tell Bill we all say 👋 |
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