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Post by hellodolly on Feb 10, 2023 8:31:14 GMT -5
Got to thinking about MNKD and their past, their prior struggles, obstacles and a potential path going forward. I personally believe they're at a crossroads (in a good way) and have an opportunity to evolve into something much bigger without relying on Afrezza, but rather more on Technosphere. This has been touched on over the years, but never really in-depth because IMHO the "proof wasn't in the pudding" at that time. Today the story is different...much different.
I can see Mike repositioning the business away from selling products to the retail consumer to a model that focuses on manufacturing and distributing products such as Tyvaso or Afrezza and other drugs to large pharmaceuticals like UTHR, Novo, Lilly and others and focusing on their patented technology. Well, why?
The first thing that comes to my mind is the flexibility it would offer MNKD so they could focus on R&D of new compounds or existing drugs and away from competing against these giants. Not to mention the roadblocks from the likes of the ADA and any other potential three letter moniker that establishes the SoC for Condition X.
Next, I see an easier regulatory path through the FDA with approved drugs simply being reformulated and/or a new drug(s) given in part, at least, to the fact MNKD has taken their "proof-of-concept" with TI all the way to establishing two approved drugs using their technology. One drug from the bottom up and the other, Tyvaso, reformulated into DPI. Just take a look at the first several years of MNKD selling Afrezza v. just the first few quarters of Tyvaso's launch. It's pretty easy to see how the two compare and if you go all the way back to the beginning, you cut nearly a decade of trials out of the picture with certain drugs.
Who wouldn't want more partnerships with another BP like we have with UTHR? They have the deep pockets, they fund the FDA and they are in a class all by themselves. I wouldn't want MNKD to settle for just any BP but the RIGHT BP. One that will not only sign up for just one drug to convert to DPI but, like UTHR...provide conditions for a second or third drug to be tested.
I'm OK with royalties, collaboration and services as revenue and moving away from a sales force constantly competing for face time with an Endo or Mike having to find another tool for the bag, aka throwing good money after bad.
The peds trial, India PHIII trial, pump switch trials, etc could have more of an implication on my rambling thoughts but, we'll have to wait and see. As to the Type 2s...if someone else can cross into that group, I'm OK with collecting revenue on Afrezza royalties and manufacturing, too. Thoughts?
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Post by lennymnkd on Feb 10, 2023 9:15:22 GMT -5
Agree with your post , but was hoping for direct to consumer with products
With less barriers to entry… for maximum profits .. migraine/ nicotine..
but I guess there are just so many hrs in a day . And money in the bank
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Post by hellodolly on Feb 10, 2023 9:43:35 GMT -5
Agree with your post , but was hoping for direct to consumer with products With less barriers to entry… for maximum profits .. migraine/ nicotine.. but I guess there are just so many hrs in a day . And money in the bank They may still have to conduct DTC on their own drugs until someone is interested but, years and years and years and years...of trials, delays, funding, etc. A partner can help offset a lot of the financial obligations associated with developing DTC compounds. NTM is an example of a drug being repurposed. If they stay in that lane, I feel that's a route towards DTC and can save MNKD time and $$$. |
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Post by akemp3000 on Feb 10, 2023 9:46:29 GMT -5
Excellent post hellodolly. I agree. Al Mann always envisioned Mannkind becoming the TS drug developmental company you've described. This follows what he had done with his prior companies. He did not envision Mannkind becoming a drug manufacturer/supplier/distributor. When Sanofi departed, it appeared at the time the only path available was to try to go it alone which required becoming the manufacturer, supplier and distributor. Hindsight is easy and we now know that going after the diabetes market was the ultimate challenging target for TS possible. Maybe it would have been better to start off smaller than David versus Goliath. Regardless, it appears Mike Castagna has put this train back on the track that Al envisioned.
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Post by hellodolly on Feb 10, 2023 10:08:11 GMT -5
Excellent post hellodolly. I agree. Al Mann always envisioned Mannkind becoming the TS drug developmental company you've described. This follows what he had done with his prior companies. He did not envision Mannkind becoming a drug manufacturer/supplier/distributor. When Sanofi departed, it appeared at the time the only path available was to try to go it alone which required becoming the manufacturer, supplier and distributor. Hindsight is easy and we now know that going after the diabetes market was the ultimate challenging target for TS possible. Maybe it would have been better to start off smaller than David versus Goliath. Regardless, it appears Mike Castagna has put this train back on the track that Al envisioned. You have a longer history with MNKD, although I jumped in right around the time of the announcement of the partnership with SNY. Thanks for reminding me of the vision of Al Mann. I'm glad to see he had a lot more in mind for TI than just Afrezza. What a giant misfortune and turn of events with SNY & for everyone...including investors. To be able to still talk about it with those who were here during the ADCOM days remains one of the biggest stories on this board. Their steadfast faith and knowledge of the potential for TI kept many people like me interested and invested in this company. I'm sure many others left broken and dejected over the wealth destruction and have never looked back. I belong to various biotech platforms with so-called "biotech experts" or "market gurus" and nobody believes MNKD has a story to tell and that it remains nothing more than a "serial disappointer." Might have been the case in the past but, there are plenty of stories we can all pull from our investment life spans and see how with the right people and the right vision, a SD can turn into a champion. |
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Post by radgray68 on Feb 10, 2023 15:52:53 GMT -5
As I recall, we did have some 46 different compounds that fit onto our platform. Probably even more by now.
Al could probably picture $100 million in royalties from each of those 46 drugs eventually. That explains what Al said about buying more shares at $2.00 “and I still think they’re cheap.”
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Post by akemp3000 on Feb 10, 2023 16:34:08 GMT -5
If Mannkind had failed a few years back as some projected, there would be no story. If however, this goes on to great success as many now believe, the stories are going to make a hit movie; Al Mann being personally confronted by Shkreli, Shkreli gaslighting the FDA to issue the CRL causing a lengthy delay, the personal story lines of FDA members, the price action at ADCOM and so much more since then. For those not around on the day of the ADCOM vote, the MNKD pps plunged for about 30 minutes that morning on a false rumor from an "unknown source" causing many long time retail investors to sell out only to then watch the price recover and skyrocket 30 minutes later. The manipulation was obvious. A class action lawsuit was threatened but there was no one to sue. Investing in emerging biotechs is not for the weak. I can't wait for the movie  |
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Post by cretin11 on Feb 10, 2023 17:26:43 GMT -5
As I recall, we did have some 46 different compounds that fit onto our platform. Probably even more by now. Al could probably picture $100 million in royalties from each of those 46 drugs eventually. That explains what Al said about buying more shares at $2.00 “and I still think they’re cheap.” I think he said that about shares at $200, not $2.00? (Of course, $200 per share then is equal to $1000 per share today.) Afrezza was never intended to be the end of the story, but rather the initial proof of concept for the Technosphere platform leading to dozens of compounds and revenue streams. |
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Post by prcgorman2 on Feb 11, 2023 1:49:40 GMT -5
As I recall, we did have some 46 different compounds that fit onto our platform. Probably even more by now. Al could probably picture $100 million in royalties from each of those 46 drugs eventually. That explains what Al said about buying more shares at $2.00 “and I still think they’re cheap.” I think he said that about shares at $200, not $2.00? (Of course, $200 per share then is equal to $1000 per share today.) Afrezza was never intended to be the end of the story, but rather the initial proof of concept for the Technosphere platform leading to dozens of compounds and revenue streams. For some reason your posts often remind me of the end scene in “The Life of Brian” where numerous unfortunate individuals are hanging from crosses singing “Always look on the bright side of life”. I agree with everything that was said in these posts in this thread, but I still can’t bring myself to turn my back on Afrezza, and there are two main reasons; greed, and how much I think the product matters as a “life changing” treatment for Persons With Diabetes. So, while I agree that Mannkind was intended to be, and should be, a pipeline business, I feel both the desire for riches from a successful margin of plurality in the T2 prandial insulin marketplace, and an obligation to promote continuance of the manufacture and sale of Afrezza for the sake of diabetics if nothing else. I’m 100% ok with Afrezza eventually going off patent and some other manufacturer(s) making generic versions. That would actually be very gratifying. |
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Post by hellodolly on Feb 11, 2023 9:11:20 GMT -5
I think he said that about shares at $200, not $2.00? (Of course, $200 per share then is equal to $1000 per share today.) Afrezza was never intended to be the end of the story, but rather the initial proof of concept for the Technosphere platform leading to dozens of compounds and revenue streams. For some reason your posts often remind me of the end scene in “The Life of Brian” where numerous unfortunate individuals are hanging from crosses singing “Always look on the bright side of life”. I agree with everything that was said in these posts in this thread, but I still can’t bring myself to turn my back on Afrezza, and there are two main reasons; greed, and how much I think the product matters as a “life changing” treatment for Persons With Diabetes. So, while I agree that Mannkind was intended to be, and should be, a pipeline business, I feel both the desire for riches from a successful margin of plurality in the T2 prandial insulin marketplace, and an obligation to promote continuance of the manufacture and sale of Afrezza for the sake of diabetics if nothing else. I’m 100% ok with Afrezza eventually going off patent and some other manufacturer(s) making generic versions. That would actually be very gratifying. I agree with you about Afrezza and not turning your back, but can't help to think that it was once our lifeline or the "bread of life" that kicked off this whole story and how MNKD was able to survive because of this drug. It's going to be the gift that keeps on giving even if we exit from marketing and sales. I too also agree with and desire for riches "from a successful margin of plurality in the T2 prandial insulin marketplace..." but that's just where the story continues for Afrezza. Do we necessarily need Novo, Lilly, or any of the cartel behemoths to take Afrezza into that market? I don't have the answer but, as has been posted many times, they are marketing different drugs so, Afrezza would just compete rather than compliment their drug therapies. But, we've talked a lot about "time in range" being a significant contributor to better outcomes for PWDs. Could it be possible for DXCM to buy the Afrezza franchise and begin to combine the device with the drug as a combo? Hear me out on this wild rambling. Back in my prior life, I spent an entire career devoted to public safety. There was a time in my career that Tasers were not an option, they didn't exist. Well, to make a long story short, the company that manufactured them was able to utilize the smart technology that has been developed over just the last two decades where they expanded into body cams. Yes, AXON was TASR and they have developed into a $13B MC global company. They've even been able to put a tiny video camera into the Taser itself to be able to record an event and use that in conjunction with the body cams. Stay with me I'm going to get to my point soon. The next and most important feature of this story is the connection I want to make with DXCM and Afrezza. Throughout the development of the body cams and tasers (and we may have investors also in MNKD who know the story) came the necessity to store all of this evidence being captured on the cameras, both on the Taser and/or the body cam. I remember having to go back to the office, take a a CD-R, upload the video onto a CD by using a USB port on the bottom of the Taser, place the CD into evidence along with the empty taser cartridge(s) that had to be collected at the scene and preserved (they all have serial numbers, etc.), and submit the appropriate paperwork. This process was not cumbersome but somewhat time consuming but, trust me, everything with that job is time consuming except eating jelly donuts. Evidence warehouses across America become packed with bundles and bundles and bundles of CDs and more. Along comes 'cloud storage' and the answer to saving thousands and thousands of CD-Rs and evidence warehouses and storage rooms across America. AXON creates and packages a new product that they sell as a subscription for storing all these hundreds and thousands of hours of body cam footage and taser activations and their new product, branded as evidence.com, becomes a multi-billion dollar seller. One earnings call, just less than five to seven years ago, AXON shocked the market!! They were giving away their dearest most prized asset for free...their body cams. These had outgrown in sales compared to Taser over the years. Why did they do this, well...the answer was their competition. The space for body cams became competitive and they didn't want to lose market share so they went out and sold their cloud storage subscriptions to public safety agencies around the world and if you bought the subscription, they were giving you XX body cams for free. Afrezza, to me can be the cloud based storage subscription, the Kureig coffee pod, the Bartesian perfect cocktail mixer that is 100% necessary to make that perfect cup or drink. Without it, they are meaningless. Imagine how a CGM can be packaged and TIR is THE KEY component to using them. Well, we all know from users of Afrezza their experience and the benefits of Afrezza that extend beyond just the convenience and ease of use, control of their life, but the biggest is TIR. We see it over and over. I don't have the deeper answers to the regulatory questions but, I don't see an issue with owning a CGM company that also markets insulin or vice a versa. What I do see evolving in the next decade is the cartel getting into the CGM space and eventually trying to push their poison with their own devices. If they do, my bet is the device will be bundled with the prescription and it will be free so long as you pay for that prescription every 90 days, etc. In this sense, Afrezza can still be a central piece to that "bread of life" for MNKD as Mike and Co. grow the pipeline business. |
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Post by sayhey24 on Feb 12, 2023 17:57:03 GMT -5
You say - "What I do see evolving in the next decade is the cartel getting into the CGM space and eventually trying to push their poison with their own devices"
What cartel and what poison? Right now the Big 3 don't sell drugs, only devices. They don't care what insulin is prescribed as long as it qualifies their CGMs for insurance or Medicare coverage. The antiglycemic BPs such as Merck, Nova Nordisk and Lilly, etc. are selling $40B plus in SGLT2s, GLP1s etc.
Now here is the rub - the antiglycemics can not hide from the numbers the CGMs are showing, specifically the PPG numbers. At some point the CGMs are going to expose the antiglycemics once they don't have RAA coverage. Right now they have cover from the RAAs but if and when Medicare approves basal only usage for T2s to qualify for a CGM there is no coverage. Their PPG control will be exposed and this is about 150M PWDS who are T2 and on Medicare. Thats a big number.
Can MNKD leverage this? I hope so but I have not heard of any study MNKD is doing in this space.
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Post by hellodolly on Feb 15, 2023 13:04:07 GMT -5
You say - "What I do see evolving in the next decade is the cartel getting into the CGM space and eventually trying to push their poison with their own devices" What cartel and what poison? Right now the Big 3 don't sell drugs, only devices. They don't care what insulin is prescribed as long as it qualifies their CGMs for insurance or Medicare coverage. The antiglycemic BPs such as Merck, Nova Nordisk and Lilly, etc. are selling $40B plus in SGLT2s, GLP1s etc. Now here is the rub - the antiglycemics can not hide from the numbers the CGMs are showing, specifically the PPG numbers. At some point the CGMs are going to expose the antiglycemics once they don't have RAA coverage. Right now they have cover from the RAAs but if and when Medicare approves basal only usage for T2s to qualify for a CGM there is no coverage. Their PPG control will be exposed and this is about 150M PWDS who are T2 and on Medicare. Thats a big number. Can MNKD leverage this? I hope so but I have not heard of any study MNKD is doing in this space. Insulin cartels. Do we have CGM cartels? |
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