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Post by akemp3000 on Jun 2, 2023 7:50:04 GMT -5
Pfizer would be an interesting candidate for some sort of partnership, They seem quite interested in this space . Would that be to good to be true 🤔 Not long ago, the thought of Pfizer having interest in MNKD would be absurd because of the Exhubera disaster. Managements however change over time so the thought is no longer out of the question. I just wish Mannkind would announce another "UTHR like" partnership with BP. MC has alluded to this desire in the past but not so much recently. Hopefully, there are always on going talks and negotiations. The impact would probably be huge.
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Post by sayhey24 on Jun 2, 2023 8:42:54 GMT -5
so for context on dosing and API the starter dose for WEgovy is 0.25mg, the oral form which recently showed up to 15% weight loss is a massive 50mg!! the mg tested by mannkind back in 2007 was 0.5mg! OK - so what is the bottom line? Was your original concern that loading GLP1 on TS would be too expensive? Are you now suggesting it may be in the ballpark or even cheaper?
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Post by sayhey24 on Jun 2, 2023 8:54:13 GMT -5
...What I don't know is how many GLP1 users the India trial has. ... Per protocol; none as it's an exclusion criteria ("Use of glucagon-like peptide 1 receptor agonists, thiazolidinediones, or weight loss drugs in the past 3 months.") CIPLA is not trying to prove superiority. They are there to get sign-off and be able to sell Afrezza as that's all they need. OK - no GLP1s. Too bad. We will just need to wait for Mike's trial. Based on Mike's comment he suggested a 1.5-2% A1c reduction. So while CIPLA may not have tried to prove superiority it seems they may have fixed the under dosing issue and their results will be better than Affinity-2. Maybe they will release some preliminary finding during ADA2023 in 3 weeks. If Mike is correct, its a big deal.
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Post by agedhippie on Jun 2, 2023 9:05:41 GMT -5
...I just wish Mannkind would announce another "UTHR like" partnership with BP. MC has alluded to this desire in the past but not so much recently. Hopefully, there are always on going talks and negotiations. The impact would probably be huge. I would echo that. While UTHR is their only customer the MNKD share price will suffer because the market views it as luck rather than strategy (one swallow does not make a spring). Get two or three customers and the market will start to believe that spring has arrived. They cannot be indiscriminate about the partner though - the resulting drug must be a success.
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Post by cretin11 on Jun 2, 2023 9:24:34 GMT -5
...I just wish Mannkind would announce another "UTHR like" partnership with BP. MC has alluded to this desire in the past but not so much recently. Hopefully, there are always on going talks and negotiations. The impact would probably be huge. I would echo that. While UTHR is their only customer the MNKD share price will suffer because the market views it as luck rather than strategy (one swallow does not make a spring). While certain folks will bristle at that statement, it remains true today as it has been for several years now.
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Post by agedhippie on Jun 2, 2023 9:46:12 GMT -5
OK - no GLP1s. Too bad. We will just need to wait for Mike's trial. Based on Mike's comment he suggested a 1.5-2% A1c reduction. So while CIPLA may not have tried to prove superiority it seems they may have fixed the under dosing issue and their results will be better than Affinity-2. Maybe they will release some preliminary finding during ADA2023 in 3 weeks. If Mike is correct, its a big deal. I am curious about Mike's statement because the dosing instruction haven't changed. The trial is about using a protocol that has already failed (the selection criteria require that) vs. adding another step which is Afrezza in this case. If you can't seriously reduce the A1c under those circumstances something is badly wrong with your drug. This is why nobody cared about the Type 2 trial results before (plus (0.8% reduction was rather underwhelming). RAA and GLP-1 already get results around the range Mike is talking about (averaging around 1.4% reduction)
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Post by Thundersnow on Jun 2, 2023 9:56:44 GMT -5
...I just wish Mannkind would announce another "UTHR like" partnership with BP. MC has alluded to this desire in the past but not so much recently. Hopefully, there are always on going talks and negotiations. The impact would probably be huge. I would echo that. While UTHR is their only customer the MNKD share price will suffer because the market views it as luck rather than strategy (one swallow does not make a spring). Get two or three customers and the market will start to believe that spring has arrived. They cannot be indiscriminate about the partner though - the resulting drug must be a success. I believe we will see a purchase of a company before we see a new molecule from UTHR. Mike is on the hunt.....
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Post by prcgorman2 on Jun 2, 2023 10:55:24 GMT -5
I would echo that. While UTHR is their only customer the MNKD share price will suffer because the market views it as luck rather than strategy (one swallow does not make a spring). While certain folks will bristle at that statement, it remains true today as it has been for several years now. Your statement is incorrect. UTHR has not been MNKD's customer for several years, but only a few years, and if we think of "customer" in more conventional terms of a service or product being sold on some recurring basis, that definition is exclusive of the Tyvaso DPI development phase and can only mean the revenue from manufacturing and royalties which began last year.
What is presumably true about what agedhippie said is Wall Street isn't fond of a one-trick pony.
MannKind is not technically a one-trick pony because of V-Go and Afrezza, but those two FDA-approved products in the MNKD Insulin Business Unit (IBU) have not yet achieved profitability either at V-Go's previous company, or Afrezza after having been FDA-approved 9 years ago. I can't speak for other MNKD investors, but I'm still here because I know to a certainty that Afrezza is the very best mealtime insulin on the planet bar none. I'm extremely pleased at the successful development and commercialization of Tyvaso DPI which underwrites the TechnoSphere inert drug carrier molecule "platform" as bona fide with the FDA and for carrying more than just insulin. This milestone achievement may also help with commercialization of MannKind's pipeline opportunities such as clofazamine for NTM and nintenadib for IPF, as well as other potential UTHR-like partnerships. I agree with akemp3000 and others who would like to see such a partnership materialize but am pleased the future of MannKind is not dependent on it. I think a new UTHR-like partnership would be great and I'm confident agedhippie is right that Wall Street would like it too.
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Post by agedhippie on Jun 2, 2023 12:38:50 GMT -5
I think part of the problem for Wall Street is that it's unclear what Mannkind sees as it's core business. Are they a drug delivery platform for pharmas (UTHR), or are they a pharma in their own right developing and selling drugs (Afrezza, maybe clofazimine), and what the hell are they doing in medical devices (V-Go and, one day maybe, bluhale)? Right now it looks to Wall Street like they will just swing at any pitch.
This is not saying that anything needs to be shut down, but rather that Mannkind needs to define what it does and then Wall Street can quantify it and price it accordingly. If you want a repricing which is what we are talking about you need to provide a clear basis for that repricing. That clarity is a measurable strategy with focused execution. Absent that the share price will do ok, but not as well as it could because the management will be seen as tactical.
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Post by sayhey24 on Jun 2, 2023 12:41:34 GMT -5
While certain folks will bristle at that statement, it remains true today as it has been for several years now. Your statement is incorrect. UTHR has not been MNKD's customer for several years, but only a few years, and if we think of "customer" in more conventional terms of a service or product being sold on some recurring basis, that definition is exclusive of the Tyvaso DPI development phase and can only mean the revenue from manufacturing and royalties which began last year.
What is presumably true about what agedhippie said is Wall Street isn't fond of a one-trick pony.
MannKind is not technically a one-trick pony because of V-Go and Afrezza, but those two FDA-approved products in the MNKD Insulin Business Unit (IBU) have not yet achieved profitability either at V-Go's previous company, or Afrezza after having been FDA-approved 9 years ago. I can't speak for other MNKD investors, but I'm still here because I know to a certainty that Afrezza is the very best mealtime insulin on the planet bar none. I'm extremely pleased at the successful development and commercialization of Tyvaso DPI which underwrites the TechnoSphere inert drug carrier molecule "platform" as bona fide with the FDA and for carrying more than just insulin. This milestone achievement may also help with commercialization of MannKind's pipeline opportunities such as clofazimine for NTM and nintenadib for IPF, as well as other potential UTHR-like partnerships. I agree with akemp3000 and others who would like to see such a partnership materialize but am pleased the future of MannKind is not dependent on it. I think a new UTHR-like partnership would be great and I'm confident agedhippie is right that Wall Street would like it too.
Its not clear if afrezza has achieved profitability in the IBU. Mike said afrezza was at least breakeven now. He has until year end by the board mandate to make the IBU breakeven. At this point he is not providing V-Go only numbers. Clearly Wall St is not impressed with V-Go potential and to date afrezza is a proven disaster. Now that Tyvaso DPI is paying the bills Mike has time to figure out how to sell afrezza. Medicare coverage with pre auths in 2023 was a big help in defining the plan. 2024 Medicare without pre auths would be huge. Of course, the kids trial and the India trial will also help define the T1 and T2 plans. I would also say Wall St. is also not that impressed with clofazimine. To get Wall St. excited Mike needs to use his brand new phone he got for the last conference call and find a BP partner for TS GLP1 and announce a Phase 2/3 trial targeting the diet market. TS GLP1 would be much bigger than anything UTHR can bring to the table.
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Post by sayhey24 on Jun 2, 2023 12:51:41 GMT -5
I think part of the problem for Wall Street is that it's unclear what Mannkind sees as it's core business. Are they a drug delivery platform for pharmas (UTHR), or are they a pharma in their own right developing and selling drugs (Afrezza, maybe clofazimine), and what the hell are they doing in medical devices (V-Go and, one day maybe, bluhale)? Right now it looks to Wall Street like they will just swing at any pitch. This is not saying that anything needs to be shut down, but rather that Mannkind needs to define what it does and then Wall Street can quantify it and price it accordingly. If you want a repricing which is what we are talking about you need to provide a clear basis for that repricing. That clarity is a measurable strategy with focused execution. Absent that the share price will do ok, but not as well as it could because the management will be seen as tactical. Al Mann defined this for us years ago - MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing. The reality is MNKD was running out of money and Mike started grasping at straws. Then when he had UTHR covering the bills he still did not know how to sell afrezza so he picked up V-Go so he had something to put in the sales reps "bag". I would say V-Go will go back into the dumpster in time. TS GLP1 needs to be prioritized. He needs to get Martine to announce another TS based drug. He also needs to find partners for the other TS drugs in the pipeline and afrezza.
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Post by agedhippie on Jun 2, 2023 12:59:33 GMT -5
Al Mann defined this for us years ago - MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing. The reality is MNKD was running out of money and Mike started grasping at straws. Then when he had UTHR covering the bills he still did not know how to sell afrezza so he picked up V-Go so he had something to put in the sales reps "bag". I would say V-Go will go back into the dumpster in time. TS GLP1 needs to be prioritized. He needs to get Martine to announce another TS based drug. He also needs to find partners for the other TS drugs in the pipeline and afrezza. If MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing then it needs more customers to avoid being seen as being overly dependent on a single customer. Without that the share price gets penalized for that business risk. V-Go is a wasting asset. It's sales are steadily dropping YoY which is why Zealand sold it.
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Post by sayhey24 on Jun 2, 2023 14:39:26 GMT -5
Al Mann defined this for us years ago - MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing. The reality is MNKD was running out of money and Mike started grasping at straws. Then when he had UTHR covering the bills he still did not know how to sell afrezza so he picked up V-Go so he had something to put in the sales reps "bag". I would say V-Go will go back into the dumpster in time. TS GLP1 needs to be prioritized. He needs to get Martine to announce another TS based drug. He also needs to find partners for the other TS drugs in the pipeline and afrezza. If MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing then it needs more customers to avoid being seen as being overly dependent on a single customer. Without that the share price gets penalized for that business risk. V-Go is a wasting asset. It's sales are steadily dropping YoY which is why Zealand sold it. Yes - we are in violent agreement. With that said - once Mike has more trial data and hits a few more milestones such as Medicare without pre auths Mike can then fine tune his sales pitch to land a real afrezza partner. I also know I sound like a broken record with TS GLP1 but that should have significant partnering potential. While the Phase 1 was done 15 years ago I would think thats good enough to start some partnering discussion. I would be a little surprised if UTHR doesn't come up with another molecule but it would be nice to have other parnters. Assuming 1. UTHR - Tyvaso DPI 2. TBD BP - afrezza 3. TBD BP - TS GLP1 4. UTHR - molecule 2 MNKD is then off to the races and Al's vision is reality and the pps will reflect that. I know Al thought afrezza would be the greatest selling drug of all time but I think TS GLP1 has that potential. I guess having the greatest selling and the second greatest selling drugs would be OK.
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Post by prcgorman2 on Jun 2, 2023 15:37:31 GMT -5
Another great thread from sayhey24 and agedhippie. Thank you. I understand the lack-of-clarity concern for Wall Street analysts and I assume we can agree that if UTHR delivers on guidance to sell $2B+ of Tyvaso DPI (by the end of 2024?) and 10x that for Tyvaso DPI for ILD and IPF (by 2027?), Wall Street will mostly ignore whatever else might be going on at MNKD (just like now) but the valuation will be significantly better. If in that same time frame 2 other important drugs can be developed and marketed with partners the classification for MNKD will be platform/pipeline company and if without partners it will be mixed BP/platform company. (I'm guessing at the classifications based on agedhippie's post.) I'm not sure what those classifications do for or against valuation but the important point as I see it is twice as many sources of revenue regardless of classification, and then the only question is, how much revenue? I think MTOI had the right advice. Buy all the cheap shares you can.
One last comment. sayhey24 said Afrezza had been a "disaster". I agree, but I refuse to believe (anymore) that Afrezza has been a disaster either because it's not able to be sold or because it hasn't been marketed correctly unless "marketed correctly" means full-scale studies proving SAFETY and superiority. I'll accept those as requirements for being "marketed correctly" and will assert that Mike Castagna (now Dr. Castagna) was handed a steamer and a penny and asked to save the company selling the only FDA product the company had but without any prayer of Afrezza being "marketed correctly". Earl Grey's charts demonstrate that Mike was successful "enough" and I doubt anyone else could have done much better except maybe Elon Musk or Steve Jobs and they weren't available. Mike and Steven (Binder) and the Board not only kept the lights on, they positioned the company for success. We longs want amazing success and seem to agree it's possible and that MNKD can achieve it and what we armchair CEOs talk about is how to do it better/faster (by developing and selling inhalable GLP1 for example). Next Monday I plan to add a few more shares. I got a few extra shekels by surprise and I like MTOI's advice and plan to follow it. Have a great weekend.
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Post by cretin11 on Jun 2, 2023 15:55:45 GMT -5
I think part of the problem for Wall Street is that it's unclear what Mannkind sees as it's core business. Are they a drug delivery platform for pharmas (UTHR), or are they a pharma in their own right developing and selling drugs (Afrezza, maybe clofazimine), and what the hell are they doing in medical devices (V-Go and, one day maybe, bluhale)? Right now it looks to Wall Street like they will just swing at any pitch. This is not saying that anything needs to be shut down, but rather that Mannkind needs to define what it does and then Wall Street can quantify it and price it accordingly. If you want a repricing which is what we are talking about you need to provide a clear basis for that repricing. That clarity is a measurable strategy with focused execution. Absent that the share price will do ok, but not as well as it could because the management will be seen as tactical. Al Mann defined this for us years ago - MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing. The reality is MNKD was running out of money and Mike started grasping at straws. Then when he had UTHR covering the bills he still did not know how to sell afrezza so he picked up V-Go so he had something to put in the sales reps "bag". I would say V-Go will go back into the dumpster in time. TS GLP1 needs to be prioritized. He needs to get Martine to announce another TS based drug. He also needs to find partners for the other TS drugs in the pipeline and afrezza. Well (and succinctly) stated, thanks sayhey!
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