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Post by agedhippie on Jul 23, 2023 22:44:41 GMT -5
Don’t forget prior to UTHR negotiating a deal, Mike also steered the development team to do a Phase 1 trial with treprostinil on TechnoSphere, which is now the product we call Tyvaso DPI. Mike didn’t just answer the phone and ink a deal UTHR was interested in. He took the product development steps to get UTHR interested. UTHR is a normal, competitive, company. My memory is there were 3 companies developing competitive products, LQDA, MNKD, and a 3rd I don’t remember but that UTHR acquired. I can’t understand how Martine gets credit for being brilliant (and a BEAST) but when it comes to the deal with MNKD, she was just a kind, sympathetic soul offering charity to the namesake of Dr. Alfred Mann. What a load of horse manure. She’s brilliant, period. The deal with MNKD was smart. MC didn’t have to stay out of the way, he had to manage a deal and then ensure execution before, during, and after FDA approval. The deal with UTHR was done in 2018, the incentive agreement was put in place in 2020 by which time it was simply a matter of UTHR shepherding it through the FDA approval. The subsequent share price increase was linked to the 2018 agreement and nothing that Mike did subsequent to the 2020 agreement. The incentive agreement should have been structured to allow for that gain, it was sloppy. On a different note; part of Mike's pay is in stock so I would say at this point he has a pretty high single stock risk so selling down some of that is not a bearish signal especially when it's done via a plan as it mostly is. Buying more stock would be risky. In other words selling stock is expected.
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Post by agedhippie on Jul 23, 2023 9:23:21 GMT -5
The stock is free, they are RSUs. I feel that Martine should have got those instead since she is the reason the stock price is where it is. That makes so much sense! Well, it would have been an ethics issue on her part so that would never be viable, but it's a good example of what happens when you have poorly drawn incentive parameters. In this case there was nothing to do other than wait while UTHR launched the product. If the board wanted to do incentive payments a better target would have been Afrezza sales since that would require initiative and work. In the case of Tyvaso DPI all that had to be done was simply not getting in UTHR's way and the shares would get repriced to account for the new revenue stream.
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Post by agedhippie on Jul 23, 2023 8:40:37 GMT -5
Wow - 300% of target. That sounds very impressive. The closing price on 8/27/2020 was $1.70. Did Mike have to pay the $1.70 as the warrant price or were the 1M shares gifted to him and he just needed to pay the tax? The 500k sale gave him about $2.3M ... The stock is free, they are RSUs. I feel that Martine should have got those instead since she is the reason the stock price is where it is.
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Post by agedhippie on Jul 21, 2023 15:46:24 GMT -5
So, you think Mike sold all that stock to pay his tax bill? I though maybe he bought an oceanfront beach house and put the rest in Vanguard's S&P 500 fund. Check it against his stock vests.
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Post by agedhippie on Jul 21, 2023 9:53:37 GMT -5
Just like insiders selling for tax purposes recently? Is the writing on the wall again? Legit observation. Hopefully not, but anyone claiming to have a definitive answer to this should probably be viewed with skepticism. We are not privy to all the relevant info. In fairness you can be reasonably sure what is happening here. Senior management is paid partly in stock and partly in cash. When RSUs vest the IRS view this as salary and broker handling the issuing will ask how you want to pay the tax. Your options are; pay cash and get all the stock, or sell the equivalent of the tax bill and keep the rest. People almost invariably take the second option since the first option doesn't make sense unless the float is highly restricted which is not the case for the virtually all listed companies. (There is a weird corner case where you can prepay the IRS for the entire grant up front and then receive the RSUs without further tax, but there are some nasty gotchas with that one so it's very rare to use it)
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Post by agedhippie on Jul 11, 2023 22:09:37 GMT -5
Aged - its a good thing you did not know Jack Welch. He was all about "agile" before "agile" was a development fad. There use to be this "thing" know as "Welch's Mummies". I don't know if Drucker ever wrote about it. With that "can't do" and "stuck in the box" attitude you may have been a prime candidate for Jack. The crazy thing is I actually witnessed a guy being hid. If I am a guy with a problem and someone says "hey, I might have a solution for you", I am probably going to listen. With some 15 year old studies and a little selling and the success Martine has had with Tyvaso DPI I bet a pretty good story could be told to spent a few $M. The risk/reward upside if TS actually works with his glp1 are huge. Whats the downside? He is already losing 10's maybe 100's $millions doing the same thing over and over and not having it work. BTW - its July. Did Mike get done the one thing he needed to with Medicare? Jack Welch hired Drucker as an advisor. Drucker is generally credited with Jack Welch's outsourcing strategy. As it turns out that was a huge mistake in the longer term. Drucker always was better at the academic than practical side. It depends if Pfizer sees a 66% retention rate as a problem. Somehow I think not. No CEO is going to have an open door to every passing salesman trying to sell him random things - his time is far to valuable to deal with a stream of crackpot ideas.
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Post by agedhippie on Jul 11, 2023 18:26:39 GMT -5
... Peter Drucker did an interesting work on the taxonomy of companies where he compared them to the military; start ups were the storm troops, fast moving and nimble but lightly armed and not designed to hold ground, the infantry behind them who take over an hold ground but moving in formations, and finally the bureaucracy (he used the pay corp) which follows on is the infrastructure supporting everything but very slow with huge inertia. Pfizer and Abbott are the last of those; they have huge scale and need multi-year strategies, they do not change direction unless there is a catastrophe. Pfizer has decided pills so pills it will be. ... Albert Bourla has a 34% drop out rate for his glp1 pill. Maybe not a catastrophe but if you can have a direct discussion and provide a few alternative ideas which their huge staffs have not, you may very well be surprised how they can turn the Titanic on a dime. ... You are confusing startups with major enterprises. Enterprises do not turn on a dime, and that's by design. They have a strategy and that is what they are executing on. There is nothing to show these firms beyond a decade old trial with a different molecule that failed to show delayed gastric emptying and a request for money. With that story you would be lucky to even get to their admins, never mind a CEO. The first gatekeeper will kill this.
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Post by agedhippie on Jul 10, 2023 15:42:10 GMT -5
The problem is that Pfizer has an agreed strategy which is danuglipron in pill form and that's what they are focused on executing on. There is nothing to show Pfizer except an old experiment with a different molecule. They are not going to buy that. If this is truly a $90B market then Pfizer will be just fine with a 34% drop out rate because the remainder will be huge.
Peter Drucker did an interesting work on the taxonomy of companies where he compared them to the military; start ups were the storm troops, fast moving and nimble but lightly armed and not designed to hold ground, the infantry behind them who take over an hold ground but moving in formations, and finally the bureaucracy (he used the pay corp) which follows on is the infrastructure supporting everything but very slow with huge inertia. Pfizer and Abbott are the last of those; they have huge scale and need multi-year strategies, they do not change direction unless there is a catastrophe. Pfizer has decided pills so pills it will be.
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Post by agedhippie on Jul 10, 2023 10:25:08 GMT -5
It's not that I would rather it just go away, it's more that I don't think it's a good candidate. We already know that GLP-1 doesn't change gastric emptying, and that it clears very rapidly. That alone is likely to be the reason why there are no side effects (no drug = no side effects or benefits.) This will not be quick, look at the development work for Tyvaso, and the issue with this is that the market is rapidly evolving (GLP-1 -> GLP-1 + GIP -> GLP-1 + GIP + Glucagon -> ? ). There is a serious risk that the result is redundant by the time it's produced.
More to the point I feel that the MNKD approach right now is to go for drugs where there is minimal competition which makes sense for a company the size of MNKD.
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Post by agedhippie on Jul 9, 2023 18:18:48 GMT -5
That's pretty much what I know. For the benefit of others here is the relevant section from the 10K filing Sayhey found. A year later this was was abandoned. (My emphasis on the most interesting sections) We conducted a second Phase 1 trial to assess the effect of MKC253 on post-meal glucose excursions in patients with type 2 diabetes. A total of 15 subjects were each given MKC253, placebo or exenatide on different days and followed for a four-hour period after each administration. In both fasted and fed subjects, inhalation of MKC253 produced a rise in insulin levels that peaked within 10 — 15 minutes. In fasted subjects, this increase in insulin led to a rapid decrease in blood glucose concentrations within 30 minutes, with a slower decline over the next 3.5 hours. Subjects who were fed and given MKC253 displayed a blunting of the initial post-meal glucose excursion for approximately 30-50 minutes, depending on the dose. In the same subjects, exenatide stimulated insulin release but produced much lower peak levels than those produced by MKC253 in either the fed or fasted state. Nonetheless, over the four-hour study period, exenatide also produced mean decreases in blood glucose concentrations. This observation may be due to the fact that exenatide had a profound effect on gastric emptying, with approximately 90% of the meal retained in the stomach at four hours after meal ingestion. In contrast, MKC253 did not have any overall effect on gastric emptying. Until we have conducted a full program of clinical trials, we will not be able to reach definitive conclusions about the potential safety or efficacy of MKC253.The first highlighted part were the drugs involved; MKC253 (GLP-1 on TS), placebo (probably pure TS), and exenatide (Byetta as Bydureon wasn't released for another 7 years.) The second highlight is why GLP-1 on TS will never be used - it doesn't slow gastric emptying. That's game over. ... I can not find the word you used "That's game over" Lets also remember this was as a T2 medication not obesity.... Let me help your reading comprehension. "That's game over" was not italicized and was in my commentary so why do you think you can find it in the 10K? The key finding is that gastric emptying was unchanged, that is why it's game over for GLP-1 on TS. Now they could move to GLP-1 analogs, but those are different molecules so the side effects findings for GLP-1 becomes irrelevant and they are back to square one.
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Post by agedhippie on Jul 9, 2023 14:03:40 GMT -5
I misspelt it. It was MKC180 and the comparator was exenatide. Now you have the right spelling Google should find it! The issue was that GLP-1 did not significantly slow gastric emptying compared to exenatide. That's hardly surprising though as it's a well known problem given the half life of GLP-1. OK - do you have a link to the study results or any additional information? You seem to know a bit about this study. Based on your response I am assuming they did not load Bydureon on TS. I am also assuming they did not load Victoza on TS. Peppy - Mr. Google shows MKC-180 in this 10k filing along with MKC253. investors.mannkindcorp.com/node/11476/htmlThat's pretty much what I know. For the benefit of others here is the relevant section from the 10K filing Sayhey found. A year later this was was abandoned. (My emphasis on the most interesting sections) We conducted a second Phase 1 trial to assess the effect of MKC253 on post-meal glucose excursions in patients with type 2 diabetes. A total of 15 subjects were each given MKC253, placebo or exenatide on different days and followed for a four-hour period after each administration. In both fasted and fed subjects, inhalation of MKC253 produced a rise in insulin levels that peaked within 10 — 15 minutes. In fasted subjects, this increase in insulin led to a rapid decrease in blood glucose concentrations within 30 minutes, with a slower decline over the next 3.5 hours. Subjects who were fed and given MKC253 displayed a blunting of the initial post-meal glucose excursion for approximately 30-50 minutes, depending on the dose. In the same subjects, exenatide stimulated insulin release but produced much lower peak levels than those produced by MKC253 in either the fed or fasted state. Nonetheless, over the four-hour study period, exenatide also produced mean decreases in blood glucose concentrations. This observation may be due to the fact that exenatide had a profound effect on gastric emptying, with approximately 90% of the meal retained in the stomach at four hours after meal ingestion. In contrast, MKC253 did not have any overall effect on gastric emptying. Until we have conducted a full program of clinical trials, we will not be able to reach definitive conclusions about the potential safety or efficacy of MKC253.The first highlighted part were the drugs involved; MKC253 (GLP-1 on TS), placebo (probably pure TS), and exenatide (Byetta as Bydureon wasn't released for another 7 years.) The second highlight is why GLP-1 on TS will never be used - it doesn't slow gastric emptying. That's game over.
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Post by agedhippie on Jul 9, 2023 11:30:43 GMT -5
Well that's very interesting. I can't find anything on MK180. Can you provide a link? And they did this with liraglutide too and the results were not good? I misspelt it. It was MKC180 and the comparator was exenatide. Now you have the right spelling Google should find it! The issue was that GLP-1 did not significantly slow gastric emptying compared to exenatide. That's hardly surprising though as it's a well known problem given the half life of GLP-1.
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Post by agedhippie on Jul 8, 2023 10:04:40 GMT -5
Don't guess why it was abandoned, read the correspondence. You seem fixated on the idea that Richardson in some way has rights to this work. He doesn't. This is about property rights. Mannkind paid for the work and it's theirs to do with as they want. If I buy a car and leave it in the yard for the next 20 years at no point do any of the workers who built it have the right to claim it as theirs. The same applies to intellectual property - it remains theirs until they sell it. I am in no way fixated on Richardson having any rights to this. What I wanted to know was who submitted the patent and I answered my own question. Its was MNKD. We also know MNKD refilled 12/2022. What I am fixated on is I remember both Peter and Al being so excited about this before the Exubera cancer scare in 2007 and MNKD's cash crunch. Why? What I am also fixated on is Albert Bourla thinking the "oral" diet market is a $90B market. What I am also fixated on is Mike did not seem to know anything about this last year, MNKD refilled the patent in 12/2022 but I have yet to see it on any of Mike's pipeline charts for an investigative study. Now, I am some what fixated on the new form 4 fillings from MNKD showing Mike selling stock for the last few months. What I would like to see is a proof of concept for native glp1 and liraglutide on TS. Actually this was in development long after 2007, it was only discontinued in 2010. Mannkind had a variant of it, MK180, that targeted obesity so they know how this behaves with meals. The issue they saw with TS delivered GLP-1 was that it didn't delay stomach emptying which is going to kill the satiety that makes people eat less. I am not that surprised because the fast clearance removed the block that delayed stomach emptying. In other words they have done the exploratory work to know that this doesn't work so they are unlikely to waste money by repeating it hence they abandoned the project in which was one of their better periods for funding.
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Post by agedhippie on Jul 8, 2023 9:29:36 GMT -5
As far as I know, most patents are not then turned into actual embodiments of the invention. Also, I’ve been told by a patent attorney that 3 to 5 years is the average time between filing an application, and an application grant, if a patent is granted. Obviously, some happen in shorter and longer time frames. Filing in 2022 would mean you should expect to see a patent, if one is granted, between 2025 and 2027. I don’t know how much the grant of a patent has to do with the decision to move forward in earnest with a patent embodiment. If it’s tightly tied, you likely won’t hear anything for awhile. Typically patents are never turned into a product, not least because most of them wouldn't stand close scrutiny (look what happened to UTHR's patents they used on LQDA) but they can delay or complicate a competitor's path to market, again UTHR and LQDA. Alternately they can be sold to patent trolls who use them to extort money from companies. Defensively they can be used to counter patent attack, back in the day IBM was the master of that strategy with huge numbers of patents under their control. Your timeline looks right. I had one patent filed where I was several companies down the line when it was approved. If you intend to use the patent then you wouldn't wait for approval because you want to get facts on the ground. The longer you wait the higher the chance that it leaks and you get competitors. Eventually you will get the patent, but now the lines are blurred and they can try to claim prior art so defending it gets a lot harder. This is why this particular patent will never be used in my opinion - the abandoned filing exposes the workings so now anyone can pick it up. To compound that the Chinese have already shown FDKP used to deliver drugs so there is an issue with prior art right there.
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Post by agedhippie on Jul 7, 2023 12:20:24 GMT -5
When I asked the question we had no idea who filed the application. I later posted MNKD did. My point was nothing would have stopped Peter from filling his own patent after he left the company if MNKD did not. Why they waited 8 years I have no idea when the work was done in 2007. I doubt it was an "intellectual property sweep" but more of a question from Al after Peter left asking whatever happened to the TS GLP1 work Peter had done. Why they abandoned it, I can only guess. What we do know is they refiled in 12/2022. What we also know is this is not currently on any MNKD pipeline slide. Don't guess why it was abandoned, read the correspondence. You seem fixated on the idea that Richardson in some way has rights to this work. He doesn't. This is about property rights. Mannkind paid for the work and it's theirs to do with as they want. If I buy a car and leave it in the yard for the next 20 years at no point do any of the workers who built it have the right to claim it as theirs. The same applies to intellectual property - it remains theirs until they sell it.
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