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Post by Thundersnow on Nov 23, 2024 13:40:21 GMT -5
Afrezza for PEDS will be approved and MNKD will partner with a large Pharma to market it. A good friend is a PEDS Endo and he has training sessions scheduled. Once the READ OUT is public MNKD will start negotiations. Remember when Sanofi said they want 6 - 9 Months to prepare for a drug launch. Most BP's are similar. Also this could be a reason why MNKD cut their salesforce by 45% and are focused on high volume clients. No need to waste resources in underperforming areas when a larger BP can handle those areas. I cannot see a partner out there: 1) They would have to compete with the major producers of which Lilly and Novo Nordisk have their own insulin in this slot, and Sanofi has been burnt once and is focused on basal insulin. 2) Insurance. Any partner is going to run headlong into the same formulary issues as MNKD has with the majors having the market sewn up. 3) Afrezza is essentially MDI and that is out of favor with the endos. They want AID pumps and Afrezza isn't pumpable. Talking to other people on pumps nobody would be prepared to give up their pump, but there is interest in the rescue inhaler idea for fast carbs. More generally they liked the idea of fast onset, and disliked the fast clearance (food hangs around). A follow-up dose was a complete non-starter (I don't have to do that now). I can see Sanofi coming back bc their Aprida is sucking wind. I can see Pfizer or Merck getting into the prandial biz. Remember 70% of Diabetics are NOT AT GOAL and it's mainly bc of mealtime insulin. Both have infrastructure to handle the globe. Also think about it....One day Afrezza could be the 1st Line treatment for Diabetics. HUGE GROWTH..... |
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Post by Thundersnow on Nov 23, 2024 13:42:21 GMT -5
I have no idea why anyone would have ever thought Ollie coming to Sanofi was going to be good for afrezza. This guy paid $1.3B to Sanofi for Exubera which Sanofi dumped when they saw what MNKD was doing. Exubera was a huge failure under Ollie and the afrezza/Sanofi deal had to be a huge embarrassment. There was no way this guy would ever let afrezza succeed. www.news.sanofi.us/press-releases?item=118413BTW based on Mike's recent comments and his experience with Tyvaso DPI I don't see him partnering with afrezza. I think he wants to keep 100% of the revenue even if it means going slow. They are still trying to figure out the T2 market with the impact of the GLP-1s. In the mean time they will see what they can do with the kids and in the gestational space. Which is why Brandicourt is no longer the CEO. He was a bad choice from the beginning and yes MNKD suffered. Vierbacher saw the future and wanted Afrezza in their arsenal. |
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Post by prcgorman2 on Nov 23, 2024 14:40:49 GMT -5
I like your enthusiasm and for anyone who doesn’t have asthma or COPD and still using Multiple Daily Injection (which could also be Multiple Daily Inhalation) therapy for mealtime insulin, Afrezza could well be a competitive product but MannKind must solve insurance coverage, period.
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Post by mpg54 on Nov 23, 2024 14:47:16 GMT -5
Get some vision....Like six months. PEDS and gestational alone will move the needle. Novo just dropped their pen...welcome aboard Novo to the best prandial insulin for adults and Pediatrics. It’s not about Vision when it’s been on the market for 10 years. Now it’s all about proving it. I’m optimistic that can still be done which is why I’m still here. I’m hopefully Peds gets the ball rolling, but once again Mike/MNKD will be the ones doing it. If he can double Afrezza revenues in an attractive timeframe then maybe a BP will take a closer look. If he is able to do it might be a reason not to partner. Next 2 years will be interesting. |
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Post by mymann on Nov 23, 2024 21:41:39 GMT -5
Let's get over this idea about Afrezza. It's been out for ten years. Our past CMO ties with ADA couldn't get it going and left. It's a meal time insulin for the people with money that can afford it. Nothing is going to change.
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Post by longliner on Nov 24, 2024 3:16:51 GMT -5
Get some vision....Like six months. PEDS and gestational alone will move the needle. Novo just dropped their pen...welcome aboard Novo to the best prandial insulin for adults and Pediatrics. when it’s been on the market for 10 years. Now it’s all about proving it. I’m optimistic that can still be done which is why I’m still here. I’m hopefully Peds gets the ball rolling, but once again Mike/MNKD will be the ones doing it. If he can double Afrezza revenues in an attractive timeframe then maybe a BP will take a closer look. If he is able to do it might be a reason not to partner. Next 2 years will be interesting. Vision in this context is forward looking. I believe that parents of children unable to find daycare that will administer injections will drive this forward quickly. I believe the current pediatric trial will prove what folks with vision have known for years. I believe that BP's with vision already recognize this. I believe they will react quickly when the results are posted. Change happens, and it's forward looking. Investing is a mix of math, history, art, psychology, science and always vision. Otherwise, six months ago, I might have predicted a buyout at less than 7 dollars per share, as a realist, with a lack of vision. I would have course have followed it with a Mike, Mike, Mike.  |
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Post by cretin11 on Nov 24, 2024 8:57:50 GMT -5
Notwithstanding longliner’s previous track record with predictions, hopefully this latest “Novo will partner on Afrezza” prediction will come true. Regardless, it’s nice to see longliner’s giddiness over the prospect. I agree that partnership would be a welcome development for MNKD and our share price. Get it done mike!
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Post by agedhippie on Nov 24, 2024 10:20:35 GMT -5
I can see Sanofi coming back bc their Aprida is sucking wind. I can see Pfizer or Merck getting into the prandial biz. Remember 70% of Diabetics are NOT AT GOAL and it's mainly bc of mealtime insulin. Both have infrastructure to handle the globe. ... Apidra has been sucking wind since it launched, which was long before Afrezza launched, as it has poor insurance coverage. It was one of the reasons why all those years ago I thought Sanofi was a good partner - they could afford to cannibalize their existing RAA market. There is no way that Pfizer or Merck want to tangle with the exisiting incumbents in a market that they have no experience of. They are far happier going for the Type 2 market and avoiding insulin. |
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Post by agedhippie on Nov 24, 2024 11:29:55 GMT -5
There is a misconception about the pediatric market. As Mike said during the UBS conference that the pediatric market is dominated by pumps, usually Omnipod. The idea that the pediatrics market is primarily MDI was true ten years ago when Afrezza was launched, but these days this is not the case. It is going to be a very hard sell to get the endos off AID pumps unless the INHALE-3 results knock the ball clear out of the park. The case for the AID pump is simple, it does the undifferentiated work for the parent. The pump will read the CGM every 5 minutes and adjust the insulin as necessary, just tell it how many carbs you eat - no meal time injection, no basal injection. Everything is done via the app so you can look at their numbers and give insulin from anywhere which is what appeals to Sayhey's tiger moms - they can be as controlling as they need even from a different country  So is it all doom and gloom? No. I would expect pediatrics to more or less double the current revenue since the parent's insurance coverage carries over to the child. The smaller addressable market in pediatrics is somewhat offset by Medicaid coverage Afrezza which should make insurance easier. Of course there is a good chance that inertia will work in Afrezza's favor for once and kids who are on Afrezza will stay on it for their adult life as well, because nobody likes change, and build up the adult Rx. |
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Post by ktim on Nov 24, 2024 16:25:44 GMT -5
Pediatrics and gestational are going to open the floodgates, welcome aboard parents of diabetic children! Lets put an end to kids being excluded from daycare due to the need for mealtime injections. Show me the pregnant women that would prefer injections to inhalations and I will laugh you off the board! Power in numbers folks, positive change is a tsunami! Why do you suppose pregnant women are going to feel that way. Seems only small numbers of people are so needle phobic that they don't very quickly get over using modern insulin pens. I'm curious what you are basing what appears to be a very strong conviction. Granted I'm not a woman and will never be pregnant, but I'm pretty sure it wouldn't bother me in the least to use injected insulin if the medical situation warranted. I think there may be arguments that Afrezza would have benefits for gestational use, just not the mere fact it's not an injection. Though as usual, success will depend on convincing PBMs to cover it. |
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Post by Thundersnow on Nov 24, 2024 22:19:04 GMT -5
Let's get over this idea about Afrezza. It's been out for ten years. Our past CMO ties with ADA couldn't get it going and left. It's a meal time insulin for the people with money that can afford it. Nothing is going to change. See.....I'm a glass FULL GUY and Afrezza 2.0 is about to START. Notice how Mike never used that term 2.0. Once PEDS is approved in 2025 Afrezza 2.0 will launch Jan. 2026 and IMO with a New Global Marketing partner. |
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Post by Thundersnow on Nov 24, 2024 22:23:11 GMT -5
There is a misconception about the pediatric market. As Mike said during the UBS conference that the pediatric market is dominated by pumps, usually Omnipod. The idea that the pediatrics market is primarily MDI was true ten years ago when Afrezza was launched, but these days this is not the case. It is going to be a very hard sell to get the endos off AID pumps unless the INHALE-3 results knock the ball clear out of the park. The case for the AID pump is simple, it does the undifferentiated work for the parent. The pump will read the CGM every 5 minutes and adjust the insulin as necessary, just tell it how many carbs you eat - no meal time injection, no basal injection. Everything is done via the app so you can look at their numbers and give insulin from anywhere which is what appeals to Sayhey's tiger moms - they can be as controlling as they need even from a different country So is it all doom and gloom? No. I would expect pediatrics to more or less double the current revenue since the parent's insurance coverage carries over to the child. The smaller addressable market in pediatrics is somewhat offset by Medicaid coverage Afrezza which should make insurance easier. Of course there is a good chance that inertia will work in Afrezza's favor for once and kids who are on Afrezza will stay on it for their adult life as well, because nobody likes change, and build up the adult Rx. AID's will be replaced if the patient is not at GOAL. Remember Mike said 70% are NOT. Any sane doctor will consider it if the DATA is strong. Afrezza's BIGGEST PROBLEM was DOSING. That has been corrected. That's why MNKD needs a Partner will brains and muscle. NOVO?? Sanofi?? I can see a Afrezza/Tresiba COMBO. Keep things easy for diabetics. |
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Post by agedhippie on Nov 25, 2024 1:01:12 GMT -5
AID's will be replaced if the patient is not at GOAL. Remember Mike said 70% are NOT. Any sane doctor will consider it if the DATA is strong. Afrezza's BIGGEST PROBLEM was DOSING. That has been corrected. That's why MNKD needs a Partner will brains and muscle. NOVO?? Sanofi?? I can see a Afrezza/Tresiba COMBO. Keep things easy for diabetics. That patient data is out of data. For the Medtronic 780G in the real world across 4,000+ users 79% are at goal . From the paper, " There were 77.3% and 79.0% of users who achieved a TIR >70% and a GMI of <7.0%, respectively" (GMI is equivalent to HbA1c but taken from a CGM rather than estimated from the blood test). That is typical for the current generation of AID pump. An AID pump lets you have less injections with less work than the Afrezza/Tresiba combo. The pump is definitely easier. If you don't want to use a pump for some reason (and there are a few!) then it's a different story. |
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