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Post by sayhey24 on May 31, 2024 13:00:38 GMT -5
"There is every reason to believe MNKD knows what they are doing" - Really? Let me give you two example why I have no reason that is correct. 1. Mike bought V-Go. It made ZERO sense from day one and now after spending $20M+ we have laid off the sales reps and pretty much put it on the back burner while selling off inventory. 2. For 10 years afrezza has had 3 issues which are still outstanding; label; SoC; Cost. Nothing has been done in the T2 arena to address these issues. We have done ZERO trials to address these. Afrezza was developed and approved for the T2 market. Instead Mike bought V-Go and told us that was the T2 solution. Endocrine business growing 7% in the month of April is a disaster. 7% of nothing is nothing. By now afrezza should be doing $Billions, not tens of $Millions. It is the greatest advance in diabetes care in over 100 years and we are afraid to do the trials against and with the GLP1s to show afrezza has as good or better T2 A1C results without all the side effects. Heck, we have not even started Gestational trials and thats a slam dunk with a well defined market. Now we have some deal with PLUM where we are paying their costs. Why are we paying their costs? What did we get - the ability to put insulin on iSperse? If iSperse is so good and better than Technosphere why didn't we just buy the company, they have no money? Explain to me how this is a good deal? I am just not getting it. MNKD-101, 201 301 and 501 are all long term hopes. Maybe they pan out maybe not. The two birds in hand right now are Tyvaso DPI and afrezza. Thank god UTHR is handling the Tyvaso DPI business and getting the sales. With afrezza we have demonstrated we have no idea what we are doing and continue to demonstrate it. The correct trials, including pediatrics, should have been done at the beginning. WTF were they thinking doing a trial with COPD and asthmatic patients, and even worse, taken them OFF their bronchodilators. Mike had a bad hand given to him at the beginning of his time as CEO. The stupidity of the COPD and asthma trials caused us a black box warning and relentless fear mongering that has damaged the reputation of Afrezza and great reluctancy from prescribers and insurance. What a disaster! They were in such a rush to get Afrezza approved they made so many mistakes that have cost us a black box warning and years being behind. The only way we take care of the main issue is to change the SoC and there’s no way around it. Well, the FDA told them to do those stupid trials. Exubera and its legacy left little choice. Have these been done with iSperse yet? Thats another thing which will need to be done. When I say afrezza has three issues and the label is one but the black box is not the big issue. Its the dosing. The dosing is wrong and calling them 4u 8u and 12u was a huge marketing mistake. They should be small, medium and large. The last I checked Mike asked for this opportunity and was hired in 2016. He was at the 2016 ASM and that is where I first met him. That was 8 years ago. For 8 years we have NOT done the trials. A T2 redo should have been done with proper dosing day 1. That was what Sanofi was going to do before Brandicourt showed up. Gestational should have been Day 2. Why did it take Mike 7 years to figure out the dosing on the label was wrong? We knew it at the Adcom when the FDA challenged the one doctor. He told them how he dosed and why he did what he did. The problem for insurers is not the black box. Its the SoC. It is not in the SoC. Its not in the SoC because we did not do proper trials with proper dosing. Why have we not done that in 8 years for the T2s? Instead we buy V-Go. Now, if we think iSperse is better for Clofazimine than Technosphere why did we not pay $500k to PLUM to put it on iSperse and do a pilot? We don't know if its any better than technosphere, maybe it is but if so why didn't we pay them $500k for the pilot and if it was great a licensing agreement for another $500k. Why did we jump in and pick up maybe 10 people at $500k per? Then we have another $1M or $2M in facility cost. This is another $10M potential boondoggle. An iSperse DPI version of Clofazamine is at least 5 years away, maybe more and another $300M to build the factory. |
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Post by mango on May 31, 2024 14:21:07 GMT -5
The correct trials, including pediatrics, should have been done at the beginning. WTF were they thinking doing a trial with COPD and asthmatic patients, and even worse, taken them OFF their bronchodilators. Mike had a bad hand given to him at the beginning of his time as CEO. The stupidity of the COPD and asthma trials caused us a black box warning and relentless fear mongering that has damaged the reputation of Afrezza and great reluctancy from prescribers and insurance. What a disaster! They were in such a rush to get Afrezza approved they made so many mistakes that have cost us a black box warning and years being behind. The only way we take care of the main issue is to change the SoC and there’s no way around it. Well, the FDA told them to do those stupid trials. Exubera and its legacy left little choice. Have these been done with iSperse yet? Thats another thing which will need to be done. When I say afrezza has three issues and the label is one but the black box is not the big issue. Its the dosing. The dosing is wrong and calling them 4u 8u and 12u was a huge marketing mistake. They should be small, medium and large. The last I checked Mike asked for this opportunity and was hired in 2016. He was at the 2016 ASM and that is where I first met him. That was 8 years ago. For 8 years we have NOT done the trials. A T2 redo should have been done with proper dosing day 1. That was what Sanofi was going to do before Brandicourt showed up. Gestational should have been Day 2. Why did it take Mike 7 years to figure out the dosing on the label was wrong? We knew it at the Adcom when the FDA challenged the one doctor. He told them how he dosed and why he did what he did. The problem for insurers is not the black box. Its the SoC. It is not in the SoC. Its not in the SoC because we did not do proper trials with proper dosing. Why have we not done that in 8 years for the T2s? Instead we buy V-Go. Now, if we think iSperse is better for Clofazimine than Technosphere why did we not pay $500k to PLUM to put it on iSperse and do a pilot? We don't know if its any better than technosphere, maybe it is but if so why didn't we pay them $500k for the pilot and if it was great a licensing agreement for another $500k. Why did we jump in and pick up maybe 10 people at $500k per? Then we have another $1M or $2M in facility cost. This is another $10M potential boondoggle. An iSperse DPI version of Clofazamine is at least 5 years away, maybe more and another $300M to build the factory. I don’t know about FDA telling MannKind to do the short COPD and asthma trials. Got a source for that? And FDA didn’t tell them to take participants off their bronchodilators. That’s why so many people had bronchospasm. |
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Post by agedhippie on May 31, 2024 15:26:44 GMT -5
... The dosing is wrong and calling them 4u 8u and 12u was a huge marketing mistake. They should be small, medium and large. ... The problem for insurers is not the black box. Its the SoC. It is not in the SoC. Its not in the SoC because we did not do proper trials with proper dosing. Why have we not done that in 8 years for the T2s? Instead we buy V-Go. ... Calling doses small, medium, and large, would have doomed Afrezza on the spot. In the aftermath of the Exubera fiasco where they hadn't used standard insulin units it was simply untenable. It would also have killed the Type 1 market, which turned out to be the only place it sold, stone dead because endos want units. Afrezza is in the SoC, search for inhaled insulin. |
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Post by lennymnkd on May 31, 2024 15:56:52 GMT -5
Sayhey aged sounds correct ! Small, medium, large sounds like T- shirts
Doesn’t sound medically professional.
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Post by prcgorman2 on May 31, 2024 16:50:08 GMT -5
Quite a lively thread about a no-cash transaction that gives MannKind an R&D boost with clofazimine in the crosshairs. I like that MannKind is not one-dimensional with respect to TS. Great technology. It saved the company based on Tyvaso DPI, but that isn’t a reason to restrict development if other options can be made available on very cash-conserving terms. I’m interested to see how things turn out and remain very optimistic.
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Post by hellodolly on May 31, 2024 21:34:45 GMT -5
Quite a lively thread about a no-cash transaction that gives MannKind an R&D boost with clofazimine in the crosshairs. I like that MannKind is not one-dimensional with respect to TS. Great technology. It saved the company based on Tyvaso DPI, but that isn’t a reason to restrict development if other options can be made available on very cash-conserving terms. I’m interested to see how things turn out and remain very optimistic. Yes, we spend way too much time looking backwards. This is all about the opportunities (highlighted below in bold) and we can't measure the impacts this will have until we see where this is going. But, it's obvious MNKD now has another bite at the apple with this transaction and all MNKD had to give up was a few cartons of plastic inhalers in exchange for...wait....wait......get this...an R&D facility in a biotech hub, full unfettered access to the iSPERSE™ technology presumably to improve the delivery of Clofazimine, lab equipment, some essential staff and they didn't spend a nickel of your money. "The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases." Comparing this deal with what Mike did or didn't do all because Al "would have, could have and should have" done it differently or failed to do it at all, is in the past and an exercise in futility. Decisions are made, decisions can be changed and in this sector, a leader better be flexible if he/she plans on existing long. Far too many external threats and challenges exist to be pigeon-holed into just being a one trick pony. We all ought to know better since investing in this space can change on a dime. Examples of the quick pace and changes in the SMID space include, "Higher for Longer" is a constant drag on the market, funding announcements, earnings, guidance, FDA moving the goal posts, delays in publications and peer reviews, competition, short sellers and more all drag on this sector and you need to have an expanding pipeline and more than one or two commercially approved products to stay alive. That, IMHO, is where Mike is leading this company. Not what you or I think but rather, what his resources and Board are steering him towards. |
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Post by cretin11 on May 31, 2024 21:53:20 GMT -5
When someone has had 28 quarters at the helm, it’s understandable for anyone to look backwards because that history can be instructive. We have to hope past is not prologue and this deal moves the needle positively.
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Post by sayhey24 on Jun 1, 2024 5:52:25 GMT -5
Quite a lively thread about a no-cash transaction that gives MannKind an R&D boost with clofazimine in the crosshairs. I like that MannKind is not one-dimensional with respect to TS. Great technology. It saved the company based on Tyvaso DPI, but that isn’t a reason to restrict development if other options can be made available on very cash-conserving terms. I’m interested to see how things turn out and remain very optimistic. Where did you get "no cash"? This is costing us from day 1 for salary and facility cost. The first year cost is about $10M. As far as Technosphere vs iSperse I don't know which one is better. Do you? What I do know Technosphere is working great for Tyvaso DPI and making money. I also know afrezza with Technosphere mimics pancreatic insulin release and iSperse is not going to do better than the pancrease. I also know building the two Technosphere factories was not cheap. Doing something similar for iSperse is probably around $300M and 3 years. That $10M could be better used doing a proper afrezza study. |
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Post by sayhey24 on Jun 1, 2024 6:03:15 GMT -5
Quite a lively thread about a no-cash transaction that gives MannKind an R&D boost with clofazimine in the crosshairs. I like that MannKind is not one-dimensional with respect to TS. Great technology. It saved the company based on Tyvaso DPI, but that isn’t a reason to restrict development if other options can be made available on very cash-conserving terms. I’m interested to see how things turn out and remain very optimistic. Yes, we spend way too much time looking backwards. This is all about the opportunities (highlighted below in bold) and we can't measure the impacts this will have until we see where this is going. But, it's obvious MNKD now has another bite at the apple with this transaction and all MNKD had to give up was a few cartons of plastic inhalers in exchange for...wait....wait......get this...an R&D facility in a biotech hub, full unfettered access to the iSPERSE™ technology presumably to improve the delivery of Clofazimine, lab equipment, some essential staff and they didn't spend a nickel of your money. "The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases." Comparing this deal with what Mike did or didn't do all because Al "would have, could have and should have" done it differently or failed to do it at all, is in the past and an exercise in futility. Decisions are made, decisions can be changed and in this sector, a leader better be flexible if he/she plans on existing long. Far too many external threats and challenges exist to be pigeon-holed into just being a one trick pony. We all ought to know better since investing in this space can change on a dime. Examples of the quick pace and changes in the SMID space include, "Higher for Longer" is a constant drag on the market, funding announcements, earnings, guidance, FDA moving the goal posts, delays in publications and peer reviews, competition, short sellers and more all drag on this sector and you need to have an expanding pipeline and more than one or two commercially approved products to stay alive. That, IMHO, is where Mike is leading this company. Not what you or I think but rather, what his resources and Board are steering him towards. Let me ask you this - is iSperse better than Technosphere? The first year cost for this is about $10M. Is it worth it? Are we going to spend another $300M to build an iSperse factory so we can use it for insulin and NTM. Do you think Martine would want Tyvaso on it too? I don't know where Mike is steering this company. I sure didn't like the V-Go purchase and the BS about how that was going to be for the T2 market. How did that work out? I also don't like another distraction so we can put insulin on iSperse. I also don't like the fact that in his 8 years at MNKD we still have not done the T2 studies for afrezza. I don't know if he is steering or snoozing. |
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Post by sayhey24 on Jun 1, 2024 6:21:18 GMT -5
Sayhey aged sounds correct ! Small, medium, large sounds like T- shirts Doesn’t sound medically professional. I remember the discussions around Exubera and all the issues with dosing. I also remember Al talking about how 4u and 8u was going to make dosing easy. Well, it did not. What it did was have existing insulin users - mostly T1s like Aged - try and do a conversion and then way under dose. Afrezza dosing is not like RAA dosing and trying to compare the two was a fatal flaw. While I said it first others like Ginger Vieira are more on my side than Aged's. As far as Aged saying it would have been doomed from the start - that is exactly what happened with the current 4u, 8u and 12u dosing and conversion chart. How much worse could it have been? What T2 knows anything about insulin conversion? What happens when the T1 sees 4u and says - oh my god 4u will kill me. The bottom line is the word "insulin" should be in microprint on the box and on the label. Afrezza users should not even think of afrezza as insulin. It should be SGP (Super Glucose Powder). I think Ginger might have another article or two on afrezza dosing but here is one "Personally, I think of the cartridges as small, medium, and large." t1dexchange.org/doctors-inhaled-insulin-t1d/ |
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Post by hellodolly on Jun 1, 2024 7:13:03 GMT -5
Yes, we spend way too much time looking backwards. This is all about the opportunities (highlighted below in bold) and we can't measure the impacts this will have until we see where this is going. But, it's obvious MNKD now has another bite at the apple with this transaction and all MNKD had to give up was a few cartons of plastic inhalers in exchange for...wait....wait......get this...an R&D facility in a biotech hub, full unfettered access to the iSPERSE™ technology presumably to improve the delivery of Clofazimine, lab equipment, some essential staff and they didn't spend a nickel of your money. "The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases." Comparing this deal with what Mike did or didn't do all because Al "would have, could have and should have" done it differently or failed to do it at all, is in the past and an exercise in futility. Decisions are made, decisions can be changed and in this sector, a leader better be flexible if he/she plans on existing long. Far too many external threats and challenges exist to be pigeon-holed into just being a one trick pony. We all ought to know better since investing in this space can change on a dime. Examples of the quick pace and changes in the SMID space include, "Higher for Longer" is a constant drag on the market, funding announcements, earnings, guidance, FDA moving the goal posts, delays in publications and peer reviews, competition, short sellers and more all drag on this sector and you need to have an expanding pipeline and more than one or two commercially approved products to stay alive. That, IMHO, is where Mike is leading this company. Not what you or I think but rather, what his resources and Board are steering him towards. Let me ask you this - is iSperse better than Technosphere? The first year cost for this is about $10M. Is it worth it? Are we going to spend another $300M to build an iSperse factory so we can use it for insulin and NTM. Do you think Martine would want Tyvaso on it too? I don't know where Mike is steering this company. I sure didn't like the V-Go purchase the the BS about how that was going to be for the T2 market. How did that work out? I also don't like another distraction so we can put insulin on iSperse. I also don't like the fact that in his 8 years at MNKD we still have not done the T2 studies for afrezza. I don't know if he is steering or snoozing. Not likely better...equal to, maybe...but, not likely he would invest in it if both were equal Different? Most definitely and I believe for that reason, Mike see's it as a need as it's very difference may enhance the outcomes and achieve certain endpoints moving forward. "Is it worth it?" After you complete the cost benefit analysis, as the CEO and the results show an outcome that produces a return on equity and investment, spending a little CAPEX is not extraordinary but necessary. This was about as cheap a deal, upfront, we could have asked for. The upfront costs we avoided are immeasurable. Back end costs? Sure, but we have added another commodity. I also don't like another distraction so we can put insulin on iSperse. "Distraction" from your desire to see the T2 study you desperately seek? Maybe stating "you hope they aren't going to use this for insulin" because Technosphere is better is absolutely factual. I would love to live long enough to see it, but I'm not wasting my time paralyzed over it. Rather than putting them in the penalty box already...yes, insulin was one of the many "use cases" mentioned in the press release but, I doubt that is their path moving forward since we already have Afrezza and Technosphere carrying that load. And, I would suggest both you and I believe that is better than iSpere. "I don't know where Mike is steering this company." I'll just leave that right there...it says it all, even the T2 studies you seek can be included in that statement. Maybe, just maybe after the converts are expired, paid off and/or shares exchanged in lieu of cash, whatever the transaction... and we are in a better cash position on the balance sheet and revenues are more stabilized Q/Q so Mike can give guidance, we'll learn just what this is all about as Mike is thinking years ahead of us. It might, as suggested, be for Clofazimine to start. Otherwise, my thoughts on this is, in part, we added iSperse to the arsenal because MNKD will do head-to-head comparisons between both platforms in future dose escalation studies with any molecule "yet to be announced". Mike made a statement during an interview on a podcast that resonates with me. Paraphrasing..."Investors are looking at the now...I'm years ahead of them already thinking about where we are going." Yes, true I don't know where Mike is steering this company either so...that makes two of us. But, I have faith that his efforts will take it the distance and we cross the finish line. It just may be as simple as having two choices, rather than just the dreamboat to get us there each time they make new discoveries or acquire a molecule. |
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Post by bthomas55ep on Jun 1, 2024 7:56:14 GMT -5
With the ongoing debate about the purpose of this deal, I still feel that the most obvious motivation is acquisition if Pulmatrix can demonstrate efficacy with DHE on Cricket in their upcoming phase 2 trial. The investment right now is a drop in the bucket if you are ultimately able to add another mnkd drug and delivery device to the portfolio long term. Let Pulmatrix conduct their phase 2 trials on Cricket for which they have already have an IND. Let them burn through the rest of their money all the while you prop them up a bit and now essentially own everything they have (all the while letting revenue and market cap continue to grow). Finish the acquisition in 2025/2026 when they are out of money in a stock deal (and a bigger market cap will afford less dilution), conduct the phase 3 DHE trials towards another approved product on Mannkind Technology, and as a byproduct,own another device technology in iSphere along with the additional pipeline of drugs it currently suggests. If I were CEO, this is certainly the way I'd be thinking about a low impact way to grow my business while still trying to be become a big boy. While $300 million in cash sounds good, with nearly as much debt coming due in the not too distant feature, Mannkind is still far from being out of the woods. Of course I know nothing, but swinging to get another ball out of the park is still a necessary reality for this business. For $10M bucks annually? They could drop that much on a big trade show. I think this would be a worthwhile strategy with acceptable levels of distraction. My $.02. GLTA
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Post by ktim on Jun 1, 2024 15:01:21 GMT -5
Now we have some deal with PLUM where we are paying their costs. Why are we paying their costs? What did we get - the ability to put insulin on iSperse? If iSperse is so good and better than Technosphere why didn't we just buy the company, they have no money? Explain to me how this is a good deal? I am just not getting it. There are often situations where it makes sense to acquire the assets of a nearly bankrupt company rather than acquiring the company (I speak from experience). A company can have debt or liabilities which is beneficial to get rid of at pennies on the dollar. Of course in this situation enough assets are being left behind that MNKD didn't even need to provide monetary compensation and likely isn't something disgruntled PLUM shareholders/creditors would stand a chance of blocking. What assets are MNKD acquiring... two, and we really don't know which of these is what they were primarily after or if both were. 1) License (limited) for iSPERSE, and 2) key employees. Yes, MNKD doesn't now own the employees, but this can still often be a motivator in acquisition of asset scenarios. Transitioning a team of technology talent can be beneficial vs trying to poach them away from a failing company one at a time before they break up and scatter form the sinking ship. Taking over the office lease, and the lab setups they have makes this a smooth and efficient transition. Ok, we do now have lease liability that will land on our balance sheet (hopefully isn't a lot). I wasn't aware of the specifics of the presence MNKD had in Boston area (perhaps details such as a lease would be in SEC filings). It appears we did have some personnel there based on the PR. What does that consist of? Was MNKD facing a situation of renewing an existing lease that we can now simply walk away from? Were they considering expanding presence there? I truly don't know enough about all of this to have an opinion on this deal. Just pointing out that there are a lot of moving parts to this, which are hard to assess from a distance. It's certainly fair to look at track record of MNKD and be skeptical... and I do think there were cases of smoke and mirrors aimed at shareholders. I'm not letting the past paint my impression of this deal because, unlike in the past, I don't really see that engaging in smoke and mirrors now would have any benefit. Back in the day MNKD partnering for THC was greeted with huge shareholder excitement (at least shareholders here) because things were looking pretty grim otherwise and marijuana was a hot topic that management knew would be lapped up by shareholders... just like mention of potential Covid plays. This deal... despite having some of the cheerleaders here doing what cheerleaders train to do, I really don't think there would be any reasonable expectation that this is going to be something that adds to shareholder optimism. Whether management's calculation/expectation is right, I'm guessing this is at least something with a serious intent rather than smoke and mirrors. |
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Post by ktim on Jun 1, 2024 15:19:01 GMT -5
Are we going to spend another $300M to build an iSperse factory so we can use it for insulin and NTM. Do you think Martine would want Tyvaso on it too? I would assume insulin was included in the license (as exclusive to MNKD) to eliminate a potential source of competition for Afrezza, rather than for MNKD to produce it themselves... not that any company would be crazy enough to try to introduce a product to compete against a market failure. |
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Post by ktim on Jun 1, 2024 15:28:37 GMT -5
With the ongoing debate about the purpose of this deal, I still feel that the most obvious motivation is acquisition if Pulmatrix can demonstrate efficacy with DHE on Cricket in their upcoming phase 2 trial. The investment right now is a drop in the bucket if you are ultimately able to add another mnkd drug and delivery device to the portfolio long term. Let Pulmatrix conduct their phase 2 trials on Cricket for which they have already have an IND. Let them burn through the rest of their money all the while you prop them up a bit and now essentially own everything they have (all the while letting revenue and market cap continue to grow). Finish the acquisition in 2025/2026 when they are out of money in a stock deal (and a bigger market cap will afford less dilution), conduct the phase 3 DHE trials towards another approved product on Mannkind Technology, and as a byproduct,own another device technology in iSphere along with the additional pipeline of drugs it currently suggests. If I were CEO, this is certainly the way I'd be thinking about a low impact way to grow my business while still trying to be become a big boy. While $300 million in cash sounds good, with nearly as much debt coming due in the not too distant feature, Mannkind is still far from being out of the woods. Of course I know nothing, but swinging to get another ball out of the park is still a necessary reality for this business. For $10M bucks annually? They could drop that much on a big trade show. I think this would be a worthwhile strategy with acceptable levels of distraction. My $.02. GLTA What would possible be the benefit of that for MNKD. Saves Pulmatrix some money in designing and testing, but it's just a plastic whistle. It takes a lot of money though to design/test/validate anything in medical space. But I'd guess zero chance any company would actually pay money to license a simple plastic inhaler from MNKD. Technosphere arguably has some value, though I certainly think as shareholders we way overvalued that in the past. But a plastic whistle inhaler... that's not going to be a revenue source for MNKD even if Pulm uses it for an FDA approved drug. That's a lot of speculation on future deals. It certainly doesn't smell like that to me. |
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