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Post by mpg54 on Nov 22, 2024 3:02:54 GMT -5
If you recall we also tried the partnership route already and it nearly sunk the company. Yes, I think he’ll have ammunition with the Peds trial data, Peds approval, and a possible label change. Do I think that would be enough for a partner to invest millions into trying to sell a previous failure, HELL NO. I don’t know what kind of deal you think is possible? Nothing that wouldn’t be a near giveaway, no thanks. I don’t believe any partnership is remotely possible at this point. Happy to be wrong, but I’d be in shocked if a deal was made that was anywhere near equitable. This ammunition is nothing more than a chance to chip away at the barriers holding the drug back. It’s not going to wipe away its 10 years of failure. It’s my belief that MNKD is going to have to prove Afrezza can be successful on its own before any potential partner would ever consider touching it. What is success, that’s a TBD, but it’s certainly not 100m a year… Nah I think you're way off base. The DATA will show Afrezza works and works very well. If you remember MNKD did not have the right DOSAGE which caused diabetics and doctors to discontinue it. To them there was no benefit and doctors were not fully trained so they were not smart enough or cared about trying to make it work. There were a few doctors that were excited and figured it out and have been very successful. With Inhale 3 and 1 it will be a paradigm shift and a large pharma (probably with a WW footprint) will partner with MNKD. MNKD is in a much stronger position than 10 years ago with Sanofi. Who knows maybe Sanofi will come back around and give MNKD a sweet deal. Time will tell...... I don’t think any BP is looking that closely at Afrezza. Like I said, I’m good with being wrong if the deal brings a Market Cap rise. I don’t think Mike is hiding anything, he’s gearing up for hard run at this.
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Post by prcgorman2 on Nov 22, 2024 7:59:54 GMT -5
Two very divergent views being expressed. One says data was all that was needed and now we will enjoy the success some other company or person can bring to MNKD shareholders. The other says experience is the teacher and 10 years has taught Afrezza is up against a mountain of data and deep pockets and even if that weren’t true, it’s the best prandial insulin yes, but it has its own challenges too such as cough and high MDI work load for self-administration as compared to a pump. I’m with mpg54. “Maybe someday” is the most we’re willing to hope for. And that’s OK. MannKind was and is a pipeline company. Two down and two in the magazine and if Mike is right and those “shots are on goal”, anybody that started investing in the last 7 years, or who did dollar cost averaging should be well rewarded.
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Post by porkini on Nov 22, 2024 10:29:46 GMT -5
If you recall we also tried the partnership route already and it nearly sunk the company. Yes, I think he’ll have ammunition with the Peds trial data, Peds approval, and a possible label change. Do I think that would be enough for a partner to invest millions into trying to sell a previous failure, HELL NO. I don’t know what kind of deal you think is possible? Nothing that wouldn’t be a near giveaway, no thanks. I don’t believe any partnership is remotely possible at this point. Happy to be wrong, but I’d be in shocked if a deal was made that was anywhere near equitable. This ammunition is nothing more than a chance to chip away at the barriers holding the drug back. It’s not going to wipe away its 10 years of failure. It’s my belief that MNKD is going to have to prove Afrezza can be successful on its own before any potential partner would ever consider touching it. What is success, that’s a TBD, but it’s certainly not 100m a year… Nah I think you're way off base. The DATA will show Afrezza works and works very well. If you remember MNKD did not have the right DOSAGE which caused diabetics and doctors to discontinue it. To them there was no benefit and doctors were not fully trained so they were not smart enough or cared about trying to make it work. There were a few doctors that were excited and figured it out and have been very successful. With Inhale 3 and 1 it will be a paradigm shift and a large pharma (probably with a WW footprint) will partner with MNKD. MNKD is in a much stronger position than 10 years ago with Sanofi. Who knows maybe Sanofi will come back around and give MNKD a sweet deal. Time will tell...... Along those same lines of "time will tell," and lest it be forgotten, the previous partnership with Sanofi also included a major management change at Sanofi. Initially, the change was thought to be positive as the executive being brought in had experience with another inhaled insulin: A former doctor who studied and practised in Paris, Brandicourt's name has been circulating for months as one of a small handful of people suitable as a potential replacement for Chris Viehbacher, sacked by Sanofi's board in October. He was also involved in Exubera. So he might be a good CEO to understand the importance of Afrezza
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Post by agedhippie on Nov 22, 2024 14:20:37 GMT -5
There was an interesting comment from Mike at the UBS conference. He said that to date they had been optimizing Afrezza for revenue, and now they were considering if they could switch to growth in light of INHALE-3. The decision would be based on the final readouts.
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Post by agedhippie on Nov 22, 2024 14:33:18 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).
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Post by sayhey24 on Nov 22, 2024 14:42:41 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.
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Post by cretin11 on Nov 22, 2024 17:27:53 GMT -5
I'm still with thundersnow in hoping we are able to find a partner. But if it turns out the PEDS results are not compelling enough to convince anyone to partner, or mike is incapable for whatever reason to land a deal, then it would seem aged is correct when he's cautioned us not to expect a huge increase in scripts from PEDS. (The previous Sanofi debacle isn't a valid reason not to partner because as pointed out above, the primary reason for that mess was the leadership change.)
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Post by Thundersnow on Nov 22, 2024 20:11:04 GMT -5
Nah I think you're way off base. The DATA will show Afrezza works and works very well. If you remember MNKD did not have the right DOSAGE which caused diabetics and doctors to discontinue it. To them there was no benefit and doctors were not fully trained so they were not smart enough or cared about trying to make it work. There were a few doctors that were excited and figured it out and have been very successful. With Inhale 3 and 1 it will be a paradigm shift and a large pharma (probably with a WW footprint) will partner with MNKD. MNKD is in a much stronger position than 10 years ago with Sanofi. Who knows maybe Sanofi will come back around and give MNKD a sweet deal. Time will tell...... I don’t think any BP is looking that closely at Afrezza. Like I said, I’m good with being wrong if the deal brings a Market Cap rise. I don’t think Mike is hiding anything, he’s gearing up for hard run at this. Are you kidding.....400 Million people have diabetes and GROWING. If they can prove Afrezza is safe and effective and can drive down your A1C easily.....Hell yeah someone is going to sign up and market it. MNKD will negotiate a very good deal bc they are in the drivers seat. Worst case....They go it alone but that will take resources which they don't have.
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Post by prcgorman2 on Nov 22, 2024 23:32:48 GMT -5
400 million? Most of those are Type 2 and almost all of them outside of the US. Less than 10% of that in the US (going from memory). If cost of manufacture is a factor in being able to deeply discount the cost for PBMs and get preferred status on insurance formularies, that COGS will be an issue (as well as getting foreign regulatory approvals) outside of the US too. I don’t know that COGS is an issue and have been very curious how marketing was going to go in India where we already have a partner (Cipla) for one of the largest ex-US populations of persons with diabetes. Maybe India can be a catalyst for what you’re saying. Fingers crossed.
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Post by mpg54 on Nov 22, 2024 23:35:36 GMT -5
I don’t think any BP is looking that closely at Afrezza. Like I said, I’m good with being wrong if the deal brings a Market Cap rise. I don’t think Mike is hiding anything, he’s gearing up for hard run at this. Are you kidding.....400 Million people have diabetes and GROWING. If they can prove Afrezza is safe and effective and can drive down your A1C easily.....Hell yeah someone is going to sign up and market it. MNKD will negotiate a very good deal bc they are in the drivers seat. Worst case....They go it alone but that will take resources which they don't have. No, I’m not kidding! It’s been 10 years, where are they? I don’t think a safety study is going to move the needle significantly. BP knows what Afrezza is and they also know it hasn’t sold or met the minimum of expectations. If I’m a BP I’m sitting back and watching, let MNKD figure out the hurdles and prove they got something in Afrezza. Who’s going to risk millions on a 10 year dud? The CEO who takes that kind risk on will immediately have their neck in a noose. If MNKD can get some traction and double sales in a year or two, then maybe they can turn some heads. Believe me, nothing would make me happier than to see the Market Cap shoot through the roof, but I’m not delusional either. Until it happens, it’s nonsense talk to me.
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Post by longliner on Nov 23, 2024 1:00:39 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.
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Post by longliner on Nov 23, 2024 1:58:57 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!
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Post by cretin11 on Nov 23, 2024 8:47:19 GMT -5
Nice to see longliner agreeing with me (more accurately, agreeing with thundersnow) about our prospects for partnering on Afrezza. Moreover, longliner appears giddy over the prospect and has even selected Novo as the partner. Sounds good to me!
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Post by agedhippie on Nov 23, 2024 11:09:42 GMT -5
Nice to see longliner agreeing with me (more accurately, agreeing with thundersnow) about our prospects for partnering on Afrezza. Moreover, longliner appears giddy over the prospect and has even selected Novo as the partner. Sounds good to me! Novo Nordisk dropped Levemir pens because their Tresiba pens fills the same role as both are basal insulin and not fast acting. They have not changed their RAA pen line up (Novolog and Fiasp) beyond being in short supply until January 2025. That rules out Novo Nordisk as a partner. I will have to track down what they have said about the shortage in calls. They will be phasing out human insulin pens. Like Levemir those are pretty much obsolete now and people should be using RAA, after all they don't make animal insulin pens either any more either.
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Post by Thundersnow on Nov 23, 2024 13:36:48 GMT -5
There was an interesting comment from Mike at the UBS conference. He said that to date they had been optimizing Afrezza for revenue, and now they were considering if they could switch to growth in light of INHALE-3. The decision would be based on the final readouts. Yes they were keeping Afrezza on life support until they got the DATA that will entice doctors to try it. Now they have the data and with PEDS Approval they will switch to a GROWTH MODEL and really kick into high gear.
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