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Post by sportsrancho on Jun 29, 2022 22:07:11 GMT -5
In a sense, I guess. In all but name. From the Mannkind site: 1991: Pharmaceutical Discovery Corporation (PDC) is incorporated. 1994: PDC files patents for Technosphere 1997: Alfred E. Mann becomes involved with PDC and then so on ... mannkindcorp.com/about/thank you, but that’s about the least important detail to clarify. I felt so compelled to find out what Bill thought. I knew we weren’t wasting 60% of Afrezza… Here are his thoughts: I read the article fairly closely and have read similar articles by the same author. Aside from grammatical syntactic deficiencies, I think there are also significant inaccuracies in content. While I have NOT studied the United deal or technology at issue closely, I have done so with Afrezza. His information is sloppy at times flat wrong. The 60% figure is one example but there are others. Here are just a couple: He says the company has been around 30 years. That’s misleading. The initial steps to forming the company that Al eventually became associated with may have occurred that long ago but that’s was not MNKD. Also Afrezza was launched on Feb 2015. He gratuitously rounds up to 8 years. He claims limitations with the excipient but I don’t find his reasoning compelling. His entire article has the veneer of authority and legitimacy but it’s kinda like a decent counterfeit. If you don’t look close it can seem real. Clearly the people at UTHR did a deep dive on the excipient before associating with MannKind. I’m certain they understand the technology much better than the author. They decided to move forward. That’s good enough for me. One last point bc I could go on all night: Afrezza’s problems are not with the technology. The technology is spectacular. The problems relate the the CRLs and the data set used to secure approval and the ossified thinking within the industry as evidenced by the ADA treatment protocols. Yes the company has had difficulties selling the product but the author draws inaccurate conclusions and misstates some basic information. Seems he started with a conclusion and then looked to write an article that would back it up. It didn’t persuade me. ~ Bill McCullough CEO Vdex Diabetes |
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Post by mnkdfann on Jun 30, 2022 0:50:30 GMT -5
thank you, but that’s about the least important detail to clarify. I felt so compelled to find out what Bill thought. I knew we weren’t wasting 60% of Afrezza… Here are his thoughts: I read the article fairly closely and have read similar articles by the same author. Aside from grammatical syntactic deficiencies, I think there are also significant inaccuracies in content. While I have NOT studied the United deal or technology at issue closely, I have done so with Afrezza. His information is sloppy at times flat wrong. The 60% figure is one example but there are others. Here are just a couple: He says the company has been around 30 years. That’s misleading. The initial steps to forming the company that Al eventually became associated with may have occurred that long ago but that’s was not MNKD. Also Afrezza was launched on Feb 2015. He gratuitously rounds up to 8 years. He claims limitations with the excipient but I don’t find his reasoning compelling. His entire article has the veneer of authority and legitimacy but it’s kinda like a decent counterfeit. If you don’t look close it can seem real. Clearly the people at UTHR did a deep dive on the excipient before associating with MannKind. I’m certain they understand the technology much better than the author. They decided to move forward. That’s good enough for me. The 61%/39% figure does appear to be (as LFD said) in the FDA prescribing insert. It may be found about halfway down on page 16 of 22 of the insert. The link to it is in the SA article. So how / why is it flat out wrong? Don't shoot the messenger, I am just wondering.  |
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Post by sportsrancho on Jun 30, 2022 6:00:21 GMT -5
Not sure, I’ll ask. It may be the difference between how much gets into the deep lung and how much gets into each patient because of inhalation techniques. Some people question if they’re getting all they can out of the inhaler. I know that’s how I read it at first because we hear it all the time. Some think it’s not working, that’s because the initial dosage should be a lot larger.
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Post by cretin11 on Jun 30, 2022 6:30:29 GMT -5
Good discussion and great to get Bill’s thoughts, especially this: “Afrezza’s problems are not with the technology. The technology is spectacular.”
Which does bring to mind the point cjc highlighted, which is if the technology is as good as we thought/hoped, why do we not have more partnership deals over the past 5 years, 2 years, etc.? I seem to recall a few years back someone at the company saying we should expect a new partnership every year, but not sure if I’m remembering that right.
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Post by agedhippie on Jun 30, 2022 9:07:17 GMT -5
It seems each time LFD puts forth one of his articles about Mannkind, the stock reacts just the opposite and moves up. Let's see if that holds true this coming week. Contrary to what Seeking Alpha would like you to think I seriously doubt anything published on Seeking Alpha is going to move the price whether it's LFD or not. Seeking Alpha is most useful for supporting confirmation bias |
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Post by hopingandwilling on Jun 30, 2022 15:43:14 GMT -5
Sports,
Always read your input into the discussions here.Tthanks for taking the time. I found your recent post, related to the evaluation being made by your employer, interesting, but I have two questions.
1) Why did your boss state that the Seeking Alpha poster was wrong about the amount of drug transfer being transported directly into the lungs with the MNKD inhaler? This got my curiosity up and I looked up the actual MannKInd label insert—and the SA poster stated verbatim what MannKind said about the transferred amount. Why would MannKind put this on the required label insert if it were not the truth?
2) Your employer also questioned the veracity of the SA poster related to the amount of time MannKind had been trying to market Afrezza. Again, I had to look this up to find that Afrezza was given final FDA approval in 2014---counting on my fingers and toes---2014-2022 this gives us 8 fiscal years they have had permission to market Afrezza. Upon approval, I would hope that MannKind was doing basic marketing of the product. The SA poster never used the term launch, he stated – “after trying for 8 years”. If everything is based on the literal time, it gets worse for MannKind. They literally have been trying to market their insulin product for more than two decades. Anyway, he used 8 years! But really! Is whether it was 5, 7, or 8 years germane to the issue topic up for discussion?
The other question I have is not related to the SA article. About six months ago I was on a business trip and met a fellow business traveler at the hotel we were staying. We had a nice friendly chat and he mentioned he lived in the Los Angeles area (he did not tell me what city, if I recall correctly.) We had a nice chat and since I was going out for dinner (Mexican Food) I asked if he wanted to join me and another business associate, I was traveling with. He declined my offer and stated he had to watch what he ate, due to his diabetic condition. Since he had told me he lived in the LA area I thought of Vdex and told him he needed to contact them about their protocol as it might help him with his issues of controlling his condition. He asked me how to make contact if he decided to make contact—I told him VDEX had offices all over the LA area and just look up the closest one to his home. With that we departed our separate way, thinking I would never see the person again. Now jump several months later, I happened to be staying in the same hotel and run into this person in the lobby. During the conversation, I asked him if he had contacted Vdex. He said he had tried but the only phone number he could find was one listed for New Mexico. (He did not mention any city, by name).
My question to you—has Vdex moved their operations to New Mexico and do they have offices in the LA area. If I recall, recently you posted here that you would secure and post a list of the Vdex locations!
Having a physical location of the Vdex offices would help all of us! Thanks!
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Post by sportsrancho on Jun 30, 2022 21:54:47 GMT -5
I believe I said the locations would be posted on the website, if you look at the Vdex social media you’ll see that Louisville Kentucky was the last clinic we opened.
The new website is not done yet but you can register to be updated when it gets done.
And I’ll ask Bill what the best number is for LA. I personally send everybody to Claudia in New Mexico because she is doing the Telehealth. She’s also our number one provider and the one that did the Afrezza inhalation TikTok video.
Thank you for your post I will relay it.
As far as your first questions go I think he just read it and notice the facts didn’t quite line up. There’s quite a few things that have been misstated from people that have not been here the length of time that Bill has. Al ..Matt and Bill ..also liane and Mannmade:-)
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Post by sayhey24 on Jul 1, 2022 8:18:37 GMT -5
Sports - LFD is not wrong about a lot of things like only about 40% of afrezza gets to the deep lung or that MNKD was started in 1991 or that afrezza has been approved for eight years.
Why LFD thinks Liquidia's product is going to do better at getting into the deep lung is a mystery. They are still going to lose some in the mouth, throat, etc. The other big question for Liquidia is can they even scale to a real production facility and whats the time frame for it? Personally I don't really care about Liquidia and them competing with UTHR. IMO, thats UTHR's job.
What I care about is what is Mike doing with afrezza? LFD is right. For eight years the product has not sold. Why? Is it really as good as Al thought? Is VDex really seeing the results you are saying? When we watch the numbers on the CGM when afrezza is taken, is the CGM wrong? I don't think so but then LFD is correct what the heck is Mike doing? At this point in time Mannkind may be the greatest marketing failure in pharama history.
When Sanofi licensed the product they had a single target, the T2 market. Stefan Schwartz was focused on getting T2s to adopt afrezza at least 5 years earlier than current T2s where adopting basal insulin. I contend afrezza is so good why wait? T2s should start before the GLP1s/SGLT2/DDP4s. Thats the $30B+ market.
The question is, is Bill correct when he says afrezza first afrezza always? Am I delusional when thinking afrezza is this good? If not then why did Mike put the T2 market "On ice" three years ago? What is this guy doing? Does Mike think afrezza sucks? Does he know something we don't?
I just don't think this is all that hard. No doctor is going to prescribe until it has its proper place in the SOC. The ADA is not going to do anything until afrezza has a head to head GLP1 study and kicks butt in A1C. Even then the ADA is not going to budge without proper marketing exposure and maybe a lawsuit. Once Mike does that afrezza should get a good chunk of that $30B+ market. The big question is can afrezza really kick butt over a selected GLPL1 in A1C? I think it can if the trial is properly designed and executed. That's the only reason I still have an interest in MNKD along with what RLS may pull off one day.
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Post by oldfishtowner on Jul 1, 2022 15:45:01 GMT -5
Sports - LFD is not wrong about a lot of things like only about 40% of afrezza gets to the deep lung or that MNKD was started in 1991 or that afrezza has been approved for eight years. Why LFD thinks Liquidia's product is going to do better at getting into the deep lung is a mystery. They are still going to lose some in the mouth, throat, etc. The other big question for Liquidia is can they even scale to a real production facility and whats the time frame for it? Personally I don't really care about Liquidia and them competing with UTHR. IMO, thats UTHR's job. What I care about is what is Mike doing with afrezza? LFD is right. For eight years the product has not sold. Why? Is it really as good as Al thought? Is VDex really seeing the results you are saying? When we watch the numbers on the CGM when afrezza is taken, is the CGM wrong? I don't think so but then LFD is correct what the heck is Mike doing? At this point in time Mannkind may be the greatest marketing failure in pharama history. When Sanofi licensed the product they had a single target, the T2 market. Stefan Schwartz was focused on getting T2s to adopt afrezza at least 5 years earlier than current T2s where adopting basal insulin. I contend afrezza is so good why wait? T2s should start before the GLP1s/SGLT2/DDP4s. Thats the $30B+ market. The question is, is Bill correct when he says afrezza first afrezza always? Am I delusional when thinking afrezza is this good? If not then why did Mike put the T2 market "On ice" three years ago? What is this guy doing? Does Mike think afrezza sucks? Does he know something we don't? I just don't think this is all that hard. No doctor is going to prescribe until it has its proper place in the SOC. The ADA is not going to do anything until afrezza has a head to head GLP1 study and kicks butt in A1C. Even then the ADA is not going to budge without proper marketing exposure and maybe a lawsuit. Once Mike does that afrezza should get a good chunk of that $30B+ market. The big question is can afrezza really kick butt over a selected GLPL1 in A1C? I think it can if the trial is properly designed and executed. That's the only reason I still have an interest in MNKD along with what RLS may pull off one day. First, if anyone has not listened to LQDA's presentation at the Jefferies Helathcare Conference, they should do so. The presentation was very slick and if I did not know better I would have immediately logged onto my broker's website and bought a bunch of their stock. Like the SeekingAlpha article its heavy on hype and light on facts.
Metformin,GLP-1, GIP/GLP-1, SGLT2, DPP4 -- how many or how large a trial does MNKD have to conduct to "own" the T2 market? Sayhey24 has suggested a few form time to time. I agree with him that the problem has been from day one that the original phase 3 trial was not ideal and MNKD and we investors have had to live with that for over 7 years.
The fact that MNKD and Cipla are running two more phase 3 trials and are both confined to a single dose of Afrezza when everyone knows at least one follow-up dose, when appropriate, will produce much better results. This tells me that it is likely that the FDA has a problem with multiple doses of Afrezza even though MNKD has conducted studies that show they are effective and safe. This is impediment one.
The second impediment ever since Sanofi dumped MNKD, has been money. Even now, if the economy dives into a deep recession, the $200 million that MNKD has in the bank is not as much as it seems, especially if circumstances activate the requirement in the MidCap loan for MNKD to maintain $90 million in cash or cash equivalents.
Also with regard to which delivery technology is superior, please look at the pk/pd data for Yutrepia. I think you will find that LQDA's delivery technology requires twice the amount of drug to obtain the same effects as MNKD's.
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Post by agedhippie on Jul 1, 2022 17:18:40 GMT -5
... Metformin,GLP-1, GIP/GLP-1, SGLT2, DPP4 -- how many or how large a trial does MNKD have to conduct to "own" the T2 market? Sayhey24 has suggested a few form time to time. I agree with him that the problem has been from day one that the original phase 3 trial was not ideal and MNKD and we investors have had to live with that for over 7 years. Let's take a trial Lilly are just spinning up. It's a mirror of the Mannkind trial that just completed to see what happens when you add Afrezza to uncontrolled Type 2. Mannkind had 28 people for 3 months, Lilly has 475 people for 10 months. The Lilly trial is going to swamp the Mannkind trial because it is more plausible (bigger numbers, longer duration). The FDA don't care how you dose, that's the point of a trial. In the worst case you do a safety trial first and then the real trial. The CIPLA trial is not handled by the FDA at all as it's an Indian trial. LFD keeps hammering that meaningless point. To a first approximation human insulin is free so efficiency is irrelevant provided you can manufacture suitable sized doses, and the person can inhale it. The issue with Afrezza is that Mannkind got the RAA to Afrezza ratio wrong when they were defining unit sizes which makes Afrezza look bad. |
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Post by sayhey24 on Jul 2, 2022 7:49:50 GMT -5
... Metformin,GLP-1, GIP/GLP-1, SGLT2, DPP4 -- how many or how large a trial does MNKD have to conduct to "own" the T2 market? Sayhey24 has suggested a few form time to time. I agree with him that the problem has been from day one that the original phase 3 trial was not ideal and MNKD and we investors have had to live with that for over 7 years. Let's take a trial Lilly are just spinning up. It's a mirror of the Mannkind trial that just completed to see what happens when you add Afrezza to uncontrolled Type 2. Mannkind had 28 people for 3 months, Lilly has 475 people for 10 months. The Lilly trial is going to swamp the Mannkind trial because it is more plausible (bigger numbers, longer duration). The FDA don't care how you dose, that's the point of a trial. In the worst case you do a safety trial first and then the real trial. The CIPLA trial is not handled by the FDA at all as it's an Indian trial. LFD keeps hammering that meaningless point. To a first approximation human insulin is free so efficiency is irrelevant provided you can manufacture suitable sized doses, and the person can inhale it. The issue with Afrezza is that Mannkind got the RAA to Afrezza ratio wrong when they were defining unit sizes which makes Afrezza look bad. Aged - I am with you. Lets get a head to head afrezza to Mounjaro trial with 500 people. Mounjaro is a once weekly shot so they only needed a blinded CGM. Afrezza users get CGMs for correction use. I have no doubt afrezza will kick butt in A1C. Where is Mike? We need this trial ASAP. I really don't think you need 500. I think 100 would do but if Lilly is doing 475 I say we go bigger. Maybe 100 for 24 weeks and 400 for 48 weeks so we can get earlier results. The reality is with CGMs we are going to know within a month or so. IMO - the India trial has zero impact on the U.S. T2 market. It was about 3 years ago Mike said afrezza sales to the T2 was on hold. Maybe its 4 years now. This India trial will do nothing to take afrezza "off ice". As far as powder getting to the deep lung LFD got it wrong. It doesn't matter if it is afrezza, Tyvaso DPI or another powder - some is going to get lost to the tongue, throat, etc. I don't really care much about Liquidia but if they have a powder they will probably lose about the same as afrezza which is about 60%. I also don't know if Liquidia can scale for production. That was a huge hurdle for afrezza back in the day. |
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Post by joeypotsandpans on Jul 2, 2022 12:41:28 GMT -5
Wonder what LFD's explanation of UTHR hitting ALL time highs is relative to the overall worst performing market to start a year in 50yrs? Doubt you'd get a response from him if he's asked that question.
What does Mr.Market know that LFD doesn't regarding his assertion of UTHR's version of Trep-T? 🤔🤷🏻♂️
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Post by Chris-C on Jul 2, 2022 14:02:54 GMT -5
I'm really surprised about this thread and the amount of hand-wringing LFD's hit piece is provoking. It's exactly what the writer was hoping. What's even more amazing to me is the number of respected longs here who seem to be concerned about it. There are no revelations. LFD does not have access to any information that has not already been publicly shared. So what's changed? Boredom? The general anxiety caused by inflation and the Bear Market? We all knew (or should have known) these were coming too. In my estimation, anyone who admits a conflict of interest confirms that they are biased (which we knew already, BTW). This means they are spinning certain information (and omitting other information) to make the point that advances the intent of their article (to champion LQDA and disparage MNKD). Even Martin Shkreli, a convicted felon and biopharma public enemy #1, used his real name when he lobbied FDA with his citizen's concerns while he was shorting MNKD. Is LFD doing this for the good of the public? We know nothing about this ghostwriter, other than that he hides behind a pen name and writes for Seeking Alpha. AFAIC, LFD's writing is propaganda dressed up as serious analysis. For those who continue to wring their hands about their MNKD investment and the "threat" from LQDA based on his article, my advice is to sell your shares and sleep better at night. Regarding the dismal sales of Afrezza: Good heavens. It's well established on this board that the company had no idea how to market Afrezza and it appears that it did not even know much about how to correctly dose its own product. That cost them valuable time and lost clients. It definitely didn't help the trial they poorly designed to submit to FDA. But their biggest failing, IMHO, was underestimating the headwinds by prescribers who had no appetite for learning a new dosing regimen and tons of skepticism about inhaled insulin based on the colossal failure of Exubera. Apparently, MNKD leaders and scientists neglected to read this interesting article written after the demise of Exubera. www.ncbi.nlm.nih.gov/pmc/articles/PMC2769732/ . It amazes me that despite the observations in the article, written 6 years before FDA approval of Afrezza, MNKD forged blindly ahead with a grossly inadequate understanding of the market. My takeaway is this: MNKD is making slow headway in the market and has diversified its portfolio, trying to get value from its novel inhaler and proven Technosphere platform. It's been a very long hard journey. But, I've never been more optimistic about the company, despite its less than spectacular history and many missteps. Nothing that LFD writes will ever have a scintilla of influence on my convictions as a long investor. |
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Post by tarheelblue004 on Jul 2, 2022 18:13:34 GMT -5
Thanks Chris for saying what was on my mind and probably others. I think the reason is boredom honestly. We rarely get news or other articles to talk about, so an article like LFDs got traction. In any case, the commentary has been really silly. For example - no one cared how much drug does not make its way into the lungs in the 8 years since Afrezza was launched; now all of a sudden it is important? We didn’t know that MannKind has been around a while, that Afrezza hasn’t sold as expected, or that we haven’t had lots of high-profile partners?
Literally nothing new in the article, and to call it biased would be an understatement. Let’s start with the title, where the author pitted Liquid vs. MannKind when the competition will actually be Liquidia vs. United Therapeutics. But to admit that would make the author’s perspective seem as silly as it actually is, so of course he chose a different framing. Where in the article did the author acknowledge that UTHR has stated to Wall Street and investors their plans to have 25,000 patients across all products by 2025, where the majority will be Tyvaso, and Tyvaso DPI will be the first-line therapy for new starts? This should put us at 12,000+ Tyvaso DPI patients by 2025 and return up to $200M / year to MannKind! Where is the acknowledgement of any of this in the article?
The author started with the assumption that Liquidia’s therapy is better than United + MannKind’s therapy, and ended with the conclusion that as a result the deal with United will not be significant for MannKind and MannKind is still a failing company. Lost within his run-on sentences, paragraphs and pages is the simple fact that even if our therapy was worse than Liquidia’s, United has tremendous patient and physician relationships and in all likelihood would still be very successful - and MannKind would be too. And btw - I am absolutely not convinced that our therapy is worse than Liquidia’s.
The only things that could stop MannKind from being successful with United are if 1) Tyvaso DPI is not successful and 2) if United drops Tyvaso DPI in favor of another therapy. Everything UTHR has said about patient and physician excitement about DPI, their Tyvaso growth rate projections, and their statements that it will be the first treatment option for new patients (unlike Sanofi for Afrezza) make #1 very unlikely to me. Given that based on conversations with United we are literally expanding our manufacturing capacity for COPD, which hasn’t even been approved yet, #2 also seems extremely unlikely to me. Liquidia fans have been hoping and praying that United will drop us and purchase them for a while now. FIN Capital produced a memorable piece a few months ago that was quite optimistic about that. Like LFD, they can keep hoping and dreaming. United chose Dreamboat / MannKind for a reason, and now that we are approved for launch, its go-time.
I genuinely don’t care what Liquidia does in the space. The market is big enough for multiple companies. Unlike Liquidia, we don’t have to try to sell the world on taking down or being purchased by the industry-leader. We are already partnered with them and ready to get going. Our time is now. The article was just a boring (seriously…how many pages does it take to make a point!?), biased, distraction.
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Post by sayhey24 on Jul 2, 2022 18:18:24 GMT -5
Chris-C - what should we be taking away from that paper? Exubera was pulled from the market for one simple reason. Pfizer did not want to make the market and do the work with the ADA and prescribers and then have afrezza come to market with all its advantages and take the market. Pfizer made a great business decision. Then they rallied with their buddies to throw the kitchen sink at afrezza to keep it from getting approved. Fat chance the ADA is going to roll over and put afrezza in its proper place without a fight.
To date MNKD has still not done the work for the T2 market. The last we heard from Mike it is still "On Ice". The kids study for the T1 market is good but the T2 market needs to be the goal. When Mike goes and buys V-Go I don't know what he is doing. Either, he does not understand afrezza or afrezza is not as good as many of us including Al Mann believed. Until I hear a plan from Mike on V-Go and how it fits with afrezza he has lost my confidence.
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