|
Post by agedhippie on Jan 19, 2024 10:06:14 GMT -5
You've got to have flying hamburgers or people dancing around a fountain to give time for the FDA disclaimer voice overs to be done. Take your pick, but due to FDA requirements most drug commercials are pretty lame. Of course it helps if a drug has some metric of superiority proven to the FDA's satisfaction and thus allowed mention in the commercial, which of course we know Afrezza does not. If you dig around you can find quite a bit of reading material on FDA “guidelines” for advertising. It is depressing. Years ago I described a commercial where two persons with diabetes get together for lunch. One retires to the restroom to administer RAA to their abdomen, the other studies the menu. They order. The RAA frets over the slow service as their BG numbers drop on ther CGM. Food arrives. Low carb on RAA, high carb on Afrezza side. After eating CGM numbers are compared over time. I’m not sure I suggested CGMs the first time I described this idea, but it would help illustrate the time action of Afrezza as compared to RAA. I doubt we’ll ever see a commercial like that, but it’s the same basic idea that MannKind will try to demonstrate with studies. Afrezza is ultra-rapid just like human insulin because it is human insulin in an immediately bio-available form. The product is awesome. But there is all this other stuff to contend with. This suffers from the same problem as the ice cream advert - it's not going to resonate with most diabetics because it's not realistic. People don't retire to the restroom to dose (well, not after the first year ), they just inject. If people don't like it that's their problem, the only down side is that it leads to questions and people telling you how to treat your diabetes. These days though you use an app on your phone and the pump does the rest. Likewise fretting over slow delivery - that's a bonus since you have now prebolused so your numbers will be better (usually you just dose when the food arrives.) As for carbs, I eat whatever I want and take insulin to cover. The CGM part is the only part that is possibly valid, but most diabetics I know are more concerned about total TIR rather than a point in time.
|
|
|
Post by agedhippie on Jan 19, 2024 9:55:54 GMT -5
^ This
The problem with the toxic debt theory is that the price at which the holders would convert their stock is far over where the price is now (the market price is $3.35 so why would they pay far more to get shares?) Suppose they decide to short; they are selling at $3.35 and they can buy Jan 2025 $4.00 Calls at $0.47 to hedge. The ability to convert at $5.21 becomes completely irrelevant, that $4.00 Call is far cheaper and delivers the same result - shares to cover the short.
MNKD statement that they will repays the debt with cash means there is no incentive for the note holders to short the stock unless the price rises above $5.21 because their convertible notes are more valuable as cash. And if they want to short the stock there are cheaper ways to do it anyway. Calling this toxic debt as it stands now is just trying to shift blame for the current share price.
|
|
|
Post by agedhippie on Jan 18, 2024 19:46:19 GMT -5
aged I think that’s been explained at length by sayhey. But it’s been rather slow around here lately so we can have a few more pages on it! sayhey my question is, how quickly would MNKD run out of money if we tried the $35 pricing? I suppose that would depend how fast we were selling it. The conundrum with your proposal. I'm curious. It's not clear to me why the insurers would care if MNKD wanted to sell Afrezza for $35. The insurance companies that do cover Afrezza would be very happy because the price to them would drop through the floor. The others would just stand back and let MNKD sell it because there is no real margin in it for them. Then in two years MNKD stop subsidizing Afrezza and what?
|
|
|
Post by agedhippie on Jan 18, 2024 19:03:27 GMT -5
The problem with trying to grow the base by subsidizing the cost (MNKD's involuntary strategy until recently) is that people worry about the day after. The insurers will not change coverage so the only option for people after the subsidy ends is to pay the full price. That leaves the same problem as you have now - endos reluctant to prescribe Afrezza because of the lack of insurance cover. Worse, in doing this the insurers that do cover Afrezza will immediately invoke the "most favored nation" clause in their contract to get Afrezza at the discounted price rather than the old price which will kill the existing revenue stream. ... I think the only way to change coverage is to disrupt the industry and that will take about 2 years... I am curious what you mean by disrupting the industry.
|
|
|
Post by agedhippie on Jan 18, 2024 17:54:28 GMT -5
As long as the convertible holders are free to short with relative impunity I will consider it "toxic". That's simply wrong. MNKD have said they will settle the loan with cash at the end of the term and have the cash on hand so there will be no shares to close a short position. The holders can and may short the stock, but they are doing it at exactly the same risk as any other short. There is definitely not any impunity, relative or otherwise.
|
|
|
Post by agedhippie on Jan 18, 2024 9:36:39 GMT -5
For years MNKD had no money and little afrezza sales. When you sell no product you make no money. While MNKD may not have made money at $35 at least they had the chance to grow the base. By now it could have been substantial, maybe the 50k Bill from Vdex wants. UTHR saved MNKD. The 2 biggest GLP1s are from Novo Nordisk and Lilly. Merck and Pfizer makes a lot with the SGLT2. Those four plus their friends would have figured out something to deep six afrezza. Exubera is still approved and so would afrezza with the same sales as Exubera. ... The problem with trying to grow the base by subsidizing the cost (MNKD's involuntary strategy until recently) is that people worry about the day after. The insurers will not change coverage so the only option for people after the subsidy ends is to pay the full price. That leaves the same problem as you have now - endos reluctant to prescribe Afrezza because of the lack of insurance cover. Worse, in doing this the insurers that do cover Afrezza will immediately invoke the "most favored nation" clause in their contract to get Afrezza at the discounted price rather than the old price which will kill the existing revenue stream.
|
|
|
Post by agedhippie on Jan 18, 2024 9:18:08 GMT -5
Gotcha. Thanks. What might be the need for Mike to go on offense at JPM with the deep explanation if this is essentially irrelevant or not really applicable? The graphs used at the JPM presentation illustrate key features (what you already identified as less relevant) concerning the differentiation of both products. If in fact UTHR uses fewer mcg to achieve better results, given the total systemic exposure as measured by AUC, while differentiated...still not significant enough to sway the medical community in either direction. Thanks again AH. I don't believe the market cares what Mike says in the context of Tyvaso-DPI, or Yutrepia. Their view is most likely that MNKD is a supplier with a suppliers level of insight into the drug itself and this is between UTHR and LQDA. Mike needs to talk about this though because it shows TS as an efficient delivery vehicle and that's MNKD's product. As to making a difference in the UTHR vs. LQDA fight I doubt anything he says has any impact with the big money (such as there is in this).
|
|
|
Post by agedhippie on Jan 17, 2024 16:50:17 GMT -5
... IMHO, the most effective outcomes can't come with an inferior product, either. Thus, the exact reason Mike mentions "bio-availability" and/or what he is referring to as the distribution into the lungs as the primary relevant factor that has a direct impact on patient outcomes. Why did he make certain to mention this in his JPM presentation, " 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." Exactly as you noted agedhippie he's not focused on technical brilliance, efficient use of API but he is focused on the most effective outcomes through bio-availability via dose distribution. What matters is the most cost effective outcomes, not purely the most effective outcomes. As long as the drug is non-inferior to the competitor then it comes down to cost. Both these drugs use the same API, the both are inhaled, and they both produce outcomes that are in line with nebulized Tyvaso. That's going to be enough to bring cost into play. The bio-availability and dose getting into the lungs are not going to matter if there are comparable outcomes from the two treatments which is what the trials suggest. The only thing that matters is a deliverable outcome, not the features.
|
|
|
Post by agedhippie on Jan 16, 2024 23:18:08 GMT -5
Mike is talking his book, which is what he should be doing as CEO. You are never going to get an unbiased view from either him of the LQDA CEO.
Just as with insulin this is going to come down to who can show the most cost effective outcomes, not technical brilliance, efficient use of API, or distribution through the lungs. The insurers are going to class these as equivalent because there isn't anything unique between them at the high level so it will probably come down to price and what deals get done. The likely impact of LQDA is that UTHR will end up reducing their price to compete as right now the have a monopoly.
|
|
|
Post by agedhippie on Jan 15, 2024 21:13:53 GMT -5
From Bill… “Interesting exchange btw aged and Sayhey. What they might not know is that the price of Afrezza is extremely volume sensitive. So if the schedule script cost is $1900 at present volumes one could probably reduce that by 75% (a very rough guess) at high volume.” I have no idea where Aged got the $1900. I am a simple guy. ... Read my post I told you exactly how I got that number.
|
|
|
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 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 agedhippie on Jan 15, 2024 13:05:43 GMT -5
Thanks for the links. Having read the presentation and the transcript it looks really interesting. There seems to be a lot of overlap with MNKD, but I think they are at least two years behind. If TPIP works it has a lot of potential and it's interesting that they are going for PH-ILD first and PAH second. As I read it TPIP is essentially a treprostinil analog and not pure treprostinil delivered via a DPI. Their existing drug, ARIKAYCE, is in trials for MAC/ NTM and is nebulized. The side effects look pretty awful, and it's licensed as a last resort drug although there is a trial running to change that label. They have a $4bn market cap and negative EPS! That's impressive!
|
|
|
Post by agedhippie on Jan 15, 2024 11:23:48 GMT -5
Thanks for the links. Having read the presentation and the transcript it looks really interesting. There seems to be a lot of overlap with MNKD, but I think they are at least two years behind. If TPIP works it has a lot of potential and it's interesting that they are going for PH-ILD first and PAH second. As I read it TPIP is essentially a treprostinil analog and not pure treprostinil delivered via a DPI. Their existing drug, ARIKAYCE, is in trials for MAC/ NTM and is nebulized. The side effects look pretty awful, and it's licensed as a last resort drug although there is a trial running to change that label.
|
|
|
Post by agedhippie on Jan 15, 2024 10:53:02 GMT -5
Not according to Mike under GAAP rules. I think (and I am not an accountant) that the treatment is much the same as a loan, in this case paid off at 10% of the royalties. It cannot be exactly the same since it is date rather than amount limited. Thanks Aged. When you say it's treated as a loan, do you mean the 150 million income is spread out over a period of time (i.e., 10 years) and not one lump sum? As opposed to actually owing money from a loan...? To be clear, i am winging this! For accounting purposes I believe the $150M is recognized at the rate the money is paid to Sagard. I could very well be completely wrong about that; but it has created a liability and ignoring that will accelerate the revenue as MNKD just received the revenue for a few years royalties on product which is has not yet been realized.
|
|