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Post by awesomo on May 30, 2024 16:36:45 GMT -5
Cretin, There’s no accuracy about it. It’s just negativity on top of negativity. Nothing but opinions of mostly doom & gloom based on zero reality and that’s my take on it. Why anyone would hold a stock if they feel this way about the company, the CEO, etc., despite the complete turnaround and all the facts of how well MNKD is doing in the here and now, is beyond me. Carry on. So please point out which of these types of deals amounted to anything. The UTHR one was a legitimate deal with a legitimate partner, other than that we have a bunch of these with no name companies or companies in financial distress that fail to ever materialize into tangible revenue, technology, or anything. |
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Post by awesomo on May 30, 2024 16:47:49 GMT -5
These types of deals have never amounted to anything for MannKind, so there's a reason for the skepticism. Tolero, Rose Pharma, Torry Pines, Receptor, Damon Dash, Charles Mattocks, One Drop, Immix, NRx, TechnoVax, Mintaka Foundation, Sun Pharma, and United. Granted, this is not a collaboration and more of a “trade,” and a good one at that, at least on paper until we know more about MannKind’s potential future plans with iSperse. Mike is responsible for 5 of the failed partnerships/collabs in the list above. However, he’s also responsible for one successful one which makes up for all the failed ones (United Therapeutics). FYI, Receptor pulled their clinical trials with Technosphere due to lack of enrollment. Matthew Pfieffer was responsible for Receptor. Tanner, Thirona |
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Post by sayhey24 on May 30, 2024 17:11:03 GMT -5
They have already tested the iSperse dry powder with insulin and apparently had good results. The iSperse utilizes cationic salt formulations. The iSperse is just a proprietary dry powder formulations just like our FDKP formulations are. They load molecules onto it like we couple molecules onto FDKP. It can be used in various modalities, and works well with high resistance inhalers, which is exactly what MannKind has. Further, iSperse can be used for formulating drug combinations, I’m not sure how feasible that is with Technosphere. It also has a strong safety profile considering its formulations are comprised of GRAS salts. www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2012.185.1_MeetingAbstracts.A2761Technosphere can handle drug combinations (i.e. can have a mixture of multiple molecules) however iSperse may be able to handle larger molecules that Technosphere can't. I think it's a great move as iSperse fits right into MNKD's wheelhouse and could potentially eliminate a competitor. Plus down the road if they are thinking of acquiring the whole company PUR1900 fits into the lung division (and could be targeted to Cystic Fibrosis as well) if they decide to revive it. How much is this great idea going to cost us in salary and facility? I thought they were trying to consolidate into Danbury? I am just not seeing this being a good move let alone great. I like it better than V-Go but not by much. The pps doesn't like it either. You would think if iSperse was so great some BP would pick them up. For whatever reason they can't seem to raise any cash. When I follow the money on this one I see a company who has no money and there is usually a reason for this. |
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Post by sayhey24 on May 30, 2024 17:33:14 GMT -5
These types of deals have never amounted to anything for MannKind, so there's a reason for the skepticism. Tolero, Rose Pharma, Torry Pines, Receptor, Damon Dash, Charles Mattocks, One Drop, Immix, NRx, TechnoVax, Mintaka Foundation, Sun Pharma, and United. Granted, this is not a collaboration and more of a “trade,” and a good one at that, at least on paper until we know more about MannKind’s potential future plans with iSperse. Mike is responsible for 5 of the failed partnerships/collabs in the list above. However, he’s also responsible for one successful one which makes up for all the failed ones (United Therapeutics). FYI, Receptor pulled their clinical trials with Technosphere due to lack of enrollment. Matthew Pfieffer was responsible for Receptor. I would say Andrea Leone-Bay was the master mind with Receptor and I had high hopes for it. What do I know? I would add V-Go to your list of failures and bump Mike's number to six. I have to give Martine the lion's share of credit for Tyvaso DPI. It was during MNKD's darkest hour when the closed sign was about to go up on the front door when she made the phone call and asked how she could help. I would also say Mike has pretty much failed to date on afrezza sales. I don't know about calling this a trade. It looks like we are paying good money for salary and facility costs and gave them Cricket. In return we get to use iSperse but for what? Is it better than Technosphere? With TS we have a very good production method. Right now iSperse is a lab activity and has never been scaled. Are we using it for MNKD-101? Mike told us we finally figured out proper TS dosing so we know clofazimine can be loaded on TS. At this point in time - I just don't get it. Lets hope Mike can add this in the win column with Tyvaso DPI but I am not optimistic. |
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Post by mango on May 30, 2024 18:13:50 GMT -5
Tolero, Rose Pharma, Torry Pines, Receptor, Damon Dash, Charles Mattocks, One Drop, Immix, NRx, TechnoVax, Mintaka Foundation, Sun Pharma, and United. Granted, this is not a collaboration and more of a “trade,” and a good one at that, at least on paper until we know more about MannKind’s potential future plans with iSperse. Mike is responsible for 5 of the failed partnerships/collabs in the list above. However, he’s also responsible for one successful one which makes up for all the failed ones (United Therapeutics). FYI, Receptor pulled their clinical trials with Technosphere due to lack of enrollment. Matthew Pfieffer was responsible for Receptor. Tanner, Thirona Yeah Tanner too. Thirona is still ongoing in the pipeline. I assume iSperse will potentially be used for it. |
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Post by mango on May 30, 2024 18:17:25 GMT -5
Tolero, Rose Pharma, Torry Pines, Receptor, Damon Dash, Charles Mattocks, One Drop, Immix, NRx, TechnoVax, Mintaka Foundation, Sun Pharma, and United. Granted, this is not a collaboration and more of a “trade,” and a good one at that, at least on paper until we know more about MannKind’s potential future plans with iSperse. Mike is responsible for 5 of the failed partnerships/collabs in the list above. However, he’s also responsible for one successful one which makes up for all the failed ones (United Therapeutics). FYI, Receptor pulled their clinical trials with Technosphere due to lack of enrollment. Matthew Pfieffer was responsible for Receptor. I would say Andrea Leone-Bay was the master mind with Receptor and I had high hopes for it. What do I know? I would add V-Go to your list of failures and bump Mike's number to six. I have to give Martine the lion's share of credit for Tyvaso DPI. It was during MNKD's darkest hour when the closed sign was about to go up on the front door when she made the phone call and asked how she could help. I would also say Mike has pretty much failed to date on afrezza sales. I don't know about calling this a trade. It looks like we are paying good money for salary and facility costs and gave them Cricket. In return we get to use iSperse but for what? Is it better than Technosphere? With TS we have a very good production method. Right now iSperse is a lab activity and has never been scaled. Are we using it for MNKD-101? Mike told us we finally figured out proper TS dosing so we know clofazimine can be loaded on TS. At this point in time - I just don't get it. Lets hope Mike can add this in the win column with Tyvaso DPI but I am not optimistic. Looks like Andrea is busy making CBD drinks and other consumer items with Spoke Sciences instead of focusing on Receptor. It was smart of Mike to stop mentioning Receptor long ago. I don’t think we are having success with loading clofazimine onto FDKP, hence in the PR they mention using the iSperse for clofazimine. They have a lot of publications on iSperse, it appears legit. As to why no BP company would scoop them if it was any good? Well, the same could be said for MannKind when we were “about to close the doors” and no one scooped us up either. |
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Post by sayhey24 on May 30, 2024 18:36:09 GMT -5
I would say Andrea Leone-Bay was the master mind with Receptor and I had high hopes for it. What do I know? I would add V-Go to your list of failures and bump Mike's number to six. I have to give Martine the lion's share of credit for Tyvaso DPI. It was during MNKD's darkest hour when the closed sign was about to go up on the front door when she made the phone call and asked how she could help. I would also say Mike has pretty much failed to date on afrezza sales. I don't know about calling this a trade. It looks like we are paying good money for salary and facility costs and gave them Cricket. In return we get to use iSperse but for what? Is it better than Technosphere? With TS we have a very good production method. Right now iSperse is a lab activity and has never been scaled. Are we using it for MNKD-101? Mike told us we finally figured out proper TS dosing so we know clofazimine can be loaded on TS. At this point in time - I just don't get it. Lets hope Mike can add this in the win column with Tyvaso DPI but I am not optimistic. Looks like Andrea is busy making CBD drinks and other consumer items with Spoke Sciences instead of focusing on Receptor. It was smart of Mike to stop mentioning Receptor long ago. I don’t think we are having success with loading clofazimine onto FDKP, hence in the PR they mention using the iSperse for clofazimine. They have a lot of publications on iSperse, it appears legit. As to why no BP company would scoop them if it was any good? Well, the same could be said for MannKind when we were “about to close the doors” and no one scooped us up either. Mango - are you suggesting Mike lied when he said they had it on TS and figured out dosing? I don't think he was. At the time, with the fire I thought they should take another 6 month delay and do the P2 with Technosphere but Mike wanted to follow the Tyvaso model. If MNKD-101 sells then the DPI version with TS would be the follow on product. OK. It worked well with Tyvaso. In fact UTHR scooped up MNKD when we were “about to close the doors” and provided an on going funding stream which may not make us rich but is paying the bills and provides the pathway to get the afrezza studies done. The problem is Mike keeps going off on tangents. Our business is centered on Technosphere. Tyvaso DPI proved the commercial viability of Technosphere. Afrezza is the greatest advance in diabetic care in over 100 years. Our business is not V-Go and not iSperse. Are we going to spend $300M and 3 years to build another factory to make iSperse clofazimine? |
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Post by cretin11 on May 30, 2024 18:48:06 GMT -5
Cretin, There’s no accuracy about it. It’s just negativity on top of negativity. Nothing but opinions of mostly doom & gloom based on zero reality and that’s my take on it. Why anyone would hold a stock if they feel this way about the company, the CEO, etc., despite the complete turnaround and all the facts of how well MNKD is doing in the here and now, is beyond me. Carry on. You’re always entitled to your take on things of course, but you offer no support or evidence for this one. You call it “negativity on top of negativity” but when people are simply stating accurate observations then it seems like shooting the messenger because you don’t like the message. |
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Post by cjm18 on May 30, 2024 19:37:11 GMT -5
Cretin, There’s no accuracy about it. It’s just negativity on top of negativity. Nothing but opinions of mostly doom & gloom based on zero reality and that’s my take on it. Why anyone would hold a stock if they feel this way about the company, the CEO, etc., despite the complete turnaround and all the facts of how well MNKD is doing in the here and now, is beyond me. Carry on. So please point out which of these types of deals amounted to anything. The UTHR one was a legitimate deal with a legitimate partner, other than that we have a bunch of these with no name companies or companies in financial distress that fail to ever materialize into tangible revenue, technology, or anything. This is only the 4th “deal” since Mike was ceo. Clofazamine deal says hi. Then vgo. |
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Post by stockwhisperer on May 31, 2024 0:11:30 GMT -5
Cretin, I am a retired, real SH and I have been here almost a decade. It has not been easy nor perfect. I do not have rose colored glasses but I have always believed in my investment in MNKD and its ultimate success.
You want real FACTS about MNKD rather then opinions & speculation - here they are - and there are many. I would expect these are the things most real shareholders & potential investors would rave about and focus on.
IMO, there is just too much positivity going on for MNKD to constantly whine, complain, nitpick & fault find. There is every reason to believe MNKD knows what they are doing and the deal they just announced will be a good one. I doubt many real shareholders would see a reason to dwell on and criticize MNKD, its CEO or prior deals - that, in your opinion(s) did not work out or should have been handled differently. What difference does it make now. Look at how well MNKD is doing. Look forward. The past is far behind MNKD. Do all deals for any company always work, no. Will this one… time will tell. Maybe, just give things a chance instead of thinking the worst because of something in the past that really has no relevance now. Imo, overall, I have never seen MNKD looking better.
FACTS…
Amazing 1st qtr 2024 conf call. In conclusion of the financial data, Steve Binder said, “I would like to thank Mike, the extended MNKD team, the MNKD Board and those SHAREHOLDERS who supported us through the dark days when our continued existence was in question, as this support allowed the executive team to execute our strategy and build MNKD into a company that has a bright future and one that WE CAN ALL BE PROUD OF. Thank you.
Over the past 8 qtrs, REVENUE has surged 250%
That equates to a run rate of $250M in REVENUE in 2024
Q1 Record Tyvaso DPi revenue of almost $48M due to strong United sales & record production in Q1 as MNKD continues to built up the expansion facility.
Q1 ended w/$304M in CASH, $2M above the prior qtr and a GAAP net income of $11M.
MNKD-101 Fast track designation and setup to meet w/Japanese authorities for clearance on pursuing registration approval as things progress and activate clinical trial sites in second half.
MNKD 101 - clofazimine inhalation suspension moves into promising area of MNKD’s nebulizer version. MNKD is next on deck for this product to be developed and be a key part of NTM treatment worldwide - over $1B opportunity.
MNKD-201 received green light to proceed to Phase 1.
ICON-1 phase 3 study design. Investigative launch meeting in June w/hopes to enroll first patient by the end of Q2.
Aligned w/FDA on co-primary end points. Phase 3 is progressing w/12 yrs of exclusivity between orphan & QIDP designation.
Next up on pipeline is IPF or cough fibrotic diseases because MNKD could be looking at PPF and other pulmonary related conditions for 201. This is an unmet need w/only 2 approved drugs littered w/failure. This is an exciting opportunity for MNKD to move this into an inhaled version, potentially reduce side effects seen in oral Ofev and maybe dose higher into lungs than possible with current products available. Rat PD bleomycin study is first indicator that the doses can meet the needs of these patients. Continuing to look at ways for best success with an inhaled version.
Endocrine business grew 7% in the month of April, year on year on Afrezza strength. Reduced V-Go sales force and in January added more resources toward Afrezza.
Gearing up to support medical as release for INHALE-3 and INHALE-1 approaches.
Pediatrics approval in 2025
Paid off mid-cap senior secured debt
Extinguished the convertible debt - cash portion pay off reduced expected dilution by over 2M shares that were backing the convertible debt.
Ended Q1with $2M more in cash & investments on balance sheet than when qtr started - without needing to sell stock or raise debt.
MNKD believes the share price paid in cash of $4.31 was a bargain for the company and see the stock in this price range as SEVERLY UNDERVALUED.
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Post by mango on May 31, 2024 7:00:16 GMT -5
Looks like Andrea is busy making CBD drinks and other consumer items with Spoke Sciences instead of focusing on Receptor. It was smart of Mike to stop mentioning Receptor long ago. I don’t think we are having success with loading clofazimine onto FDKP, hence in the PR they mention using the iSperse for clofazimine. They have a lot of publications on iSperse, it appears legit. As to why no BP company would scoop them if it was any good? Well, the same could be said for MannKind when we were “about to close the doors” and no one scooped us up either. Mango - are you suggesting Mike lied when he said they had it on TS and figured out dosing? I don't think he was. At the time, with the fire I thought they should take another 6 month delay and do the P2 with Technosphere but Mike wanted to follow the Tyvaso model. If MNKD-101 sells then the DPI version with TS would be the follow on product. OK. It worked well with Tyvaso. In fact UTHR scooped up MNKD when we were “about to close the doors” and provided an on going funding stream which may not make us rich but is paying the bills and provides the pathway to get the afrezza studies done. The problem is Mike keeps going off on tangents. Our business is centered on Technosphere. Tyvaso DPI proved the commercial viability of Technosphere. Afrezza is the greatest advance in diabetic care in over 100 years. Our business is not V-Go and not iSperse. Are we going to spend $300M and 3 years to build another factory to make iSperse clofazimine? When did he say that about clofazimine? I recall him saying they were having difficulties with loading clofazimine onto FDKP. They have even say in the PR iSperse for clofazimine. I appears Technosphere isn’t capable of delivering clofazimine. If you can pull the quote where he discusses this i’d love to read it. |
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Post by sayhey24 on May 31, 2024 7:09:15 GMT -5
There is every reason to believe MNKD knows what they are doing and the deal they just announced will be a good one. I doubt many real shareholders would see a reason to dwell on and criticize MNKD, its CEO or prior deals - that, in your opinion(s) did not work out or should have been handled differently. What difference does it make now. Look at how well MNKD is doing. Look forward. The past is far behind MNKD. Do all deals for any company always work, no. Will this one… time will tell. Maybe, just give things a chance instead of thinking the worst because of something in the past that really has no relevance now. Imo, overall, I have never seen MNKD looking better. "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. |
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Post by sayhey24 on May 31, 2024 7:22:26 GMT -5
Mango - are you suggesting Mike lied when he said they had it on TS and figured out dosing? I don't think he was. At the time, with the fire I thought they should take another 6 month delay and do the P2 with Technosphere but Mike wanted to follow the Tyvaso model. If MNKD-101 sells then the DPI version with TS would be the follow on product. OK. It worked well with Tyvaso. In fact UTHR scooped up MNKD when we were “about to close the doors” and provided an on going funding stream which may not make us rich but is paying the bills and provides the pathway to get the afrezza studies done. The problem is Mike keeps going off on tangents. Our business is centered on Technosphere. Tyvaso DPI proved the commercial viability of Technosphere. Afrezza is the greatest advance in diabetic care in over 100 years. Our business is not V-Go and not iSperse. Are we going to spend $300M and 3 years to build another factory to make iSperse clofazimine? When did he say that about clofazimine? I recall him saying they were having difficulties with loading clofazimine onto FDKP. They have even say in the PR iSperse for clofazimine. I appears Technosphere isn’t capable of delivering clofazimine. If you can pull the quote where he discusses this i’d love to read it. He said it a couple of calls ago. He said it took them some work to figure out dosing. I would think the dosing issue would be similar with iSperse. Why would putting insulin on iSperse make any sense? We would need to build a new factory which would take $300M and 3 years. Why would we ever do that? Afrezza already looks like natural pancreatic release. |
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Post by mango on May 31, 2024 7:53:58 GMT -5
There is every reason to believe MNKD knows what they are doing and the deal they just announced will be a good one. I doubt many real shareholders would see a reason to dwell on and criticize MNKD, its CEO or prior deals - that, in your opinion(s) did not work out or should have been handled differently. What difference does it make now. Look at how well MNKD is doing. Look forward. The past is far behind MNKD. Do all deals for any company always work, no. Will this one… time will tell. Maybe, just give things a chance instead of thinking the worst because of something in the past that really has no relevance now. Imo, overall, I have never seen MNKD looking better. "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. |
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Post by cretin11 on May 31, 2024 8:30:44 GMT -5
Let’s try to keep this thread on topic, please. We have different threads where we can portray our company with rose colored glasses, list all the missteps, and things of that nature. Obviously we have a checkered history of deals and decisions but this thread should be about the recently announced deal.
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