|
|
Post by hellodolly on Jan 15, 2024 12:15:58 GMT -5
This is the comments Mike made at the JPM Conference regarding DPI and Yutopia.
"I do want talk about our technology, what it means, because there’s another company out there spreading some false noise and I think it’s really important to show you that in humans we get decent lung penetration on 1. not animals and number 2., it’s not about the powder or the microns of the powder, it’s about the delivery technology combined with the powder and how that gives you deep lung penetration. And, at the end of the day we can make all kinds of arguments about low flow, high flow resistance, particle size...what matters is the bio-availability the admitted dose getting into the lungs, getting into the and showing that effects."
He is now discussing slide #10:
"This study was a pivotal trial we did back in 2018. We showed you the green line. Here is Tyvaso nebulizer and the white circles on the top are the DPI version that we did and we tested this 30 mcg increments. So, you can see 30/60/90 all the way up to 180 µg we were able to get to before we saw any tolerability issues. So, we knew this was very tolerable all the way up to 150 µg so if you look at the CMAX at roughly where the nebulizer doses (that third green dot) we delivered a higher CMAX just on our second dose. We were getting better powder and better remodeling...what that product can do for PAH patients. When you look at the competing DPI, they have to deliver almost 2X the dose just to get the same CMAX. So, if you compare it at 50 to 50, we are significantly about 2 1/2 times higher CMAX, dose for dose, and they have to dose almost twice as much powder to get to the same affect size. The way you can look at that as AUC and curve again if you just took 50 µg, which is the dose that nebulizer, that you can see we were very comparable parallel to the nebulizer and when you look at the competing DPI, they were half of what the AUC was. Therefore what that means is they need to do higher and in their particular case they need more powder and patient who has a lung disease...more powder is not necessarily good, usually leads to cough, side effects and powder going everywhere. The other part of this is as you get past 100 µg on their technology, now you need two capsules which means you need two inhalations and you gotta clean the device every day. So, our device our technology, our distribution and absorption are completely differentiated in these two things."
As we get closer to Yutpoia's launch, we will hear and read all sorts of noise from naive WS analysts, LQDA investors uncertain for the future of Yutopia and others attempting to tell a version that is filled with misinformation. Everything Mike has stated above is well documented and verifiable as the availability of both product's clinical data is available for all to see. It's apparent he see's no purpose wasting his time in getting into the high flow vs low flow resistance or particle size arguments. Rather, the focus going forward will be the bio-availability of the drug to penetrate the lungs. I would add that another implication to adoption will be the adoption of current PAH patients and their satisfaction with their current treatment.
As to the cost argument, place yourself in Yutopialand and what they're about to experience. Hope, euphoria and wishful thinking doesn't sell your drug.
|
|
|
|
Post by awesomo on Jan 15, 2024 12:34:33 GMT -5
Hope, euphoria and wishful thinking doesn't sell your drug. Well, if there were ever a group of people that should understand this, it would be MNKD investors. |
|
|
|
Post by hellodolly on Jan 15, 2024 12:43:12 GMT -5
Hope, euphoria and wishful thinking doesn't sell your drug. Well, if there were ever a group of people that should understand this, it would be MNKD investors. You catch on so fast. Bravo. |
|
|
|
Post by agedhippie on Jan 15, 2024 13:18:38 GMT -5
... As to the cost argument, place yourself in Yutopialand and what they're about to experience. Hope, euphoria and wishful thinking doesn't sell your drug. It was ever thus.  TBH it's all going to come down to insurance cover. If they can get cover then they will get prescriptions, not all and maybe not even a lot but enough to make a decent profit. My target price for them is $16.00 within a year. |
|
|
|
Post by hellodolly on Jan 15, 2024 14:50:31 GMT -5
... As to the cost argument, place yourself in Yutopialand and what they're about to experience. Hope, euphoria and wishful thinking doesn't sell your drug. It was ever thus. TBH it's all going to come down to insurance cover. If they can get cover then they will get prescriptions, not all and maybe not even a lot but enough to make a decent profit. My target price for them is $16.00 within a year. The question is when will they become profitable? Buyers will be waiting...and so will the sellers. |
|
|
|
Post by cppoly on Jan 15, 2024 15:12:10 GMT -5
It was ever thus. TBH it's all going to come down to insurance cover. If they can get cover then they will get prescriptions, not all and maybe not even a lot but enough to make a decent profit. My target price for them is $16.00 within a year. The question is when will they become profitable? Buyers will be waiting...and so will the sellers. Not to mention, LQDA market cap now exceeds MNKD'S (943 vs. 921 million). And they have a one trick pony. There's a lot more risk with LQDA in my opinion. |
|
|
|
Post by ryster505 on Jan 15, 2024 16:29:47 GMT -5
The question is when will they become profitable? Buyers will be waiting...and so will the sellers. Not to mention, LQDA market cap now exceeds MNKD'S (943 vs. 921 million). And they have a one trick pony. There's a lot more risk with LQDA in my opinion. Yeah, I think this week my share count will def be going up. |
|
|
|
Post by agedhippie on Jan 15, 2024 18:44:37 GMT -5
Not to mention, LQDA market cap now exceeds MNKD'S (943 vs. 921 million). And they have a one trick pony. There's a lot more risk with LQDA in my opinion. It's just that right now nobody knows how the pony is going to run; will it win, place, or be boiled down for glue? My money would be on a place. |
|
|
|
Post by sayhey24 on Jan 15, 2024 18:51:25 GMT -5
Why is LQDA "All About MNKD"? At best LQDA might take some sales away from UTHR but probably not much.
|
|
|
|
Post by hellodolly on Jan 16, 2024 7:01:09 GMT -5
Why is LQDA "All About MNKD"? At best LQDA might take some sales away from UTHR but probably not much. Indirectly, because a loss of sales to UTHR flows to MNKD in terms of lower royalties, as you know. It must certainly be something that's at least talked about in Danbury. If Mike was compelled to address the Yutopian vision coming from LQDA as contributing to a misinformation campaign or as he called it "False Noise", where better to begin the pushback on the noise than at the latest JPM Healthcare Conference. I expect that message to be delivered going forward, as well as in doctors offices by the UTHR sales and marketing team. They have an excellent argument and UTHR has no need to reduce prices to be competitive against an inferior product. |
|
|
|
Post by sayhey24 on Jan 16, 2024 14:14:14 GMT -5
Why is LQDA "All About MNKD"? At best LQDA might take some sales away from UTHR but probably not much. Indirectly, because a loss of sales to UTHR flows to MNKD in terms of lower royalties, as you know. It must certainly be something that's at least talked about in Danbury. If Mike was compelled to address the Yutopian vision coming from LQDA as contributing to a misinformation campaign or as he called it "False Noise", where better to begin the pushback on the noise than at the latest JPM Healthcare Conference. I expect that message to be delivered going forward, as well as in doctors offices by the UTHR sales and marketing team. They have an excellent argument and UTHR has no need to reduce prices to be competitive against an inferior product. I hope they are not talking much about LQDA. I would think UTHR contracts 6 months in advance for product. All MNKD has to do is make product. I would think UTHR thinks about them but thats not MNKDs issue. MNKD better be spending time on how they are going to get afrezza at a price people can afford. Now that we have real study data coming in, its not going to matter much if most can't afford it. |
|
|
|
Post by hellodolly on Jan 16, 2024 15:38:37 GMT -5
Indirectly, because a loss of sales to UTHR flows to MNKD in terms of lower royalties, as you know. It must certainly be something that's at least talked about in Danbury. If Mike was compelled to address the Yutopian vision coming from LQDA as contributing to a misinformation campaign or as he called it "False Noise", where better to begin the pushback on the noise than at the latest JPM Healthcare Conference. I expect that message to be delivered going forward, as well as in doctors offices by the UTHR sales and marketing team. They have an excellent argument and UTHR has no need to reduce prices to be competitive against an inferior product. I hope they are not talking much about LQDA. I would think UTHR contracts 6 months in advance for product. All MNKD has to do is make product. I would think UTHR thinks about them but thats not MNKDs issue. MNKD better be spending time on how they are going to get afrezza at a price people can afford. Now that we have real study data coming in, its not going to matter much if most can't afford it. I agree with some aspects of your concerns, but they can't be narrowly focused on the one. I think the bigger picture is MNKD competing with LQDA in another lung disease or indication and their IP and device technology will surface, again outside UTHR. You need to go to bat for your technology AND focus on getting Afrezza to people at a price they can afford. I don't want to get stuck in one place and if it doesn't work out, be years behind in another marketing or commercializing campaign for a new launch. |
|
|
|
Post by hopingandwilling on Jan 16, 2024 17:30:44 GMT -5
A False Noise Alert or Update on the Pot and the Tea Kettle:
Hello, with you being so enamored with what MannKind executives say about MannKind, Afrezza, and, therefore, their technology. Let me share the long history of what I might call BS Walks as Per MannKind Executives. Could it simply be that we are hearing False Noise from the kettle?
Let me start at the head of the food chain for this category of executives—AL MANN.
As excerpted from the LA Times:
“It would be in large part due to the efforts of Alfred Mann, CEO, founder and patron of MannKind, the Valencia, California-based biopharma, if Afrezza finally receives FDA approval next year. (1) But an equally important question is whether, if Afrezza is approved, it will actually be prescribed by physicians and used by patients.
On August 14, MannKind presented the results of its two Phase 3 Affinity trials, both of which FDA requested in a Complete Response Letter issued in 2010. Now that the dust has more or less settled around those data – on August 26 the company posted an unusually frank FAQ, in response to analyst questions on a conference call – the consensus from the analyst community on Afrezza’s approval likelihood seems to rest somewhere between yes and perhaps.
(My aside comment about the FAQ link. MannKind opted to remove this particular content from their corporate website----because it was so disastrous for Mann’s story.)
Al Mann was less ambiguous, in a phone conversation with PharmExec. “I would expect it to be approved in mid-April [2014],” says Mann. “On our schedule it looks like April 14, but it could be a few days before or after.”(2) Mann says his company will file in Europe shortly after completing the US submission. Mann says other markets are looking to the FDA and EMA as a guide on this product; however, “a number of countries are talking about approving [Afrezza] simultaneously…and one country is even talking about doing it before the US.” Which country is that? Mann wouldn’t say.
As for the question of whether physicians and patients, and payers, for that matter, will be keen to trade a syringe for an inhalation powder, (3)Mann is typically optimistic that many patients will want to switch, although other opportunities exist as well. Hakan Edstrom, MannKind’s president and chief operating officer, says the company has done “extensive research in both Europe and the US” on physician preferences, confirming that physicians see Afrezza “as an additional tool in the armamentarium of treatment options. It doesn’t necessarily have to replace something else” to be successful, says Edstrom.
(4) On the payer side, Edstrom says MannKind is currently working with Kantar Health, a data firm. Kantar recently presented findings internally to MannKind, which confirmed the company’s belief that Afrezza would be reimbursed at a premium on par with any insulin product, says Edstrom. Mann himself went further, citing discussions from two years ago with “reimbursement gatekeepers from companies that cover around 30% of American lives” indicating that Afrezza, if approved, would command a “five to 10 percent premium” over rapid-acting injectable insulins, and would achieve a Tier 2 placement alongside injectable insulin products within six months.
(5) Despite Mann’s persistence and undying enthusiasm for Afrezza, he’s something of a bull in a bear cave, with respect to inhaled insulin. Nothing shows confidence more than putting your own money at stake, but there’s no successful product forebear to offer guidance, despite a consistent interest in non-needle insulin delivery going back decades. But Afrezza comes with some very novel attributes, not least of which being an improvement on hyperglycemic events, and a convenience factor for patients who’d rather not inject themselves in public before meals. (6) If Afrezza does win approval, in Western markets and in Asian markets like China, where the population count of adults with diabetes was recently tallied at 114 million, MannKind could potentially end up with the blockbuster drug a lot of people thought it had five years ago.
My Questions with Reference to each issue I’ve numbered in the article and the fact that it has been more than ten years for investors to see how their investment in MNKD has done for them. Is the ‘pot calling the kettle black’ when talking about FALSE NOISE?
1)Now that Afrezza has been approved, have physicians prescribed and patients used Afrezza in quantities that have solely produced a profit for MannKind?
(2) (a) Has Mannkind filed in Europe for Afrezza to be marketed? (b) Has one single European country simultaneously approved Afrezza for use in their country? (c) Do you have any idea what country Al Mann was talking about approving Afrezza before it was approved in the USA?
(3) How do you feel about Al Mann and Hakan’s extensive research in Europe and the US having confirmed that physicians can hardly wait to prescribe Afrezza for their patients?
(4) Do you think Kantar Health was BSing Al and Hakan. Are you satisfied with the insurance coverage that Al and Hakan told you about ten years ago? Or could it have been False Noise coming from MannKind executives?
(5) Are you a member of the group that is still concerned with non-needle insulin delivery?
(6) Now that Afrezza is approved here in the US, could you update me on how many of the 114 million Asian citizens are using Afrezza and whether Afrezza is a BLOCKBUSTER drug and a Noisemaker?
|
|
|
|
Post by lennymnkd on Jan 16, 2024 17:41:59 GMT -5
Might of been Israel if I remember correctly.
|
|
|
|
Post by hellodolly on Jan 16, 2024 19:17:40 GMT -5
Hoping,
I'm glad you decided to reply to my post. The line was cast. Very well and thought out reply I might add, which is what I expect from you. Sadly and unfortunately for many early MNKD investors who bought into the hype and hysteria (FALSE NOISE as Mike would like to say) during the formidable years when MNKD was an early commercial stage biotech start up looking for their very first approval of their flagship product we know as Afrezza. I have no special dispensation from falling into the bag holder column. I own a couple myself that will take more time to come to fruition, with all the FALSE NOISE one expects.
FALSE NOISE as you describe is making statements that are later found to be a misleading or a misrepresentation. Looking back at all of the promises and the comments certainly bring back a flood of emotional responses and I cannot answer for Al or Hakan or even Mike. Your six questions can only be answered by those who made them. LQDA on the other hand is patently and intentionally making false statements regarding their product, which we know is inferior and Mike has been able to clearly demonstrate the differences based on the scientific literature...not hype, not false noise, not hope which certainly leaves no doubts as to what he means. None!
Forgive me for a small history lesson:
While you like to extoll all of the carnival barking virtues of Al Mann, it took him billions of his own wealth to lay the foundation for MNKD. He had every right to espouse his own thoughts on what he believed to be a game changer for those who suffer with this horrible disease. Making efforts to spread all the noise he could make, as outlined by you in your very eloquent response. Putting all that aside, in 2017, Mike Castagna came along and became the CEO, after Al passed away. In fact, with the exception of David Thomson who, started in 2000 before the three-way merger that created MannKind Corporation from CTL ImmunoTherapies Corp., AlleCure Corp. and Pharmaceutical Development Corporation, all of which were majority-owned by Alfred Mann, everyone else on the top floor was hired by Mike after Al Mann died in 2016.
Now, as you know being a bag holder and having been sucked in on the carnival barking by Al (I mean no disrespect to you or the other early investors) its very common for investors to get sucked in on the hype. It's all covered in the "Gartner Hype Cycle" where expectations rise and fall over a period of time. For MNKD, I'd say we're well into the "trough of enlightenment" but closing in on some key elements that can take MNKD to the next phase known as the "Slope of Enlightenment" where second and third iterations of product, i.e.; DPI are coming along.
Why do I point to this cycle? I see LQDA hype and false noise around their inferior product "Yutopia", (let's face it, it's well known it's inferior to what UTHR is commercializing and what MNKD is manufacturing) that I predict LQDA investors will one day find themselves beyond the peak of inflated expectations and they too become a new generation of bag holders who will be taking a seat at the table.
By the way, it sounds to me that Mike learned enough on his own, without Al, to upsell the MNKD image & their brand. In any case, I guess your reply is a confirmation of what happens with early commercial stage pharmaceuticals. The only question is will Yutopia end up like Afrezza? It sounds to me like FALSE NOISE is a common marketing and commercialization tactic amongst early stage pre-commercialization start ups, like LQDA?
|
|
