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Post by agedhippie on Mar 6, 2023 20:36:25 GMT -5
Has anyone formally asked MNKD investor relations what they are expecting? (I know that's cheating )
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Post by agedhippie on Mar 6, 2023 12:32:57 GMT -5
... Afrezza is different as it is the only insulin of form "inhaled" so in theory every insurance company has to include it in 2024 but we will see when the 2024 formularities are finalized. Emphasizing the "in theory". I don't think they have to supply all forms, I think those are just the acceptable forms. It comes down to how you read the requirements and those can be pretty opaque. If they stick with the two choice pattern you could meet the bid requirements with novolog and faiasp for example. We need to see the 2024 bid package.
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Post by agedhippie on Mar 5, 2023 15:14:26 GMT -5
agedhippie, bones is right to highlight your lack of financial investment in MNKD and by contrast your serious investment of your time and knowledge in ProBoards. One can’t help but wonder if you’re only showing us the view that supports an agenda. I have to say I’m ok with that. Caveat emptor. Your contributions, especially the debates with sayhey24 are super helpful. Thank you for being here. I suppose it depends if you see this as purely a stockboard, or more than that. If people think I am here to drive down the stock price they can only have a tenuous grip on reality - nothing that happens here affects the price regardless of what people may think. I do this because it interests me, it's a hobby. If it stops interesting me I will go away, but after eight years I rather think you are stuck with me.
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Post by agedhippie on Mar 5, 2023 11:21:04 GMT -5
Again, just a reminder, he is not a shareholder or short the stock, just spending a Saturday on random stock message boards… Totally normal What is your motive in trying to drive away someone who brings insight and knowledge to this message board? I volunteer at my local zoo. I'm glad people don't question why I spend so much time there even though I have no financial stake in the zoo. These latecomers are just jealous because I've been here years longer than them
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Post by agedhippie on Mar 5, 2023 11:02:30 GMT -5
The sale is <0.5% of his total holdings according to the filing. If a new investor is not savvy enough to see that is relatively insignificant, perhaps they should not be investing in the first place. Now, if these notices started coming out regularly, every week, for the next couple months for the same individual, I would have some concern. investors.mannkindcorp.com/node/18826/htmlYeah, it's a relatively small amount and it's tax time. Kind of a nothing-burger. I don't know why people get worked up about these sales. The key note is this line; "Transaction occurred pursuant to Rule 10B5-1 Plan." That means that these are non-discretionary calendar based sales. Mike is partly paid in stock so he has to sell some stock to get money for living expenses.
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Post by agedhippie on Mar 5, 2023 10:57:16 GMT -5
The spreadsheet from NVO? They have no plans on lowering prices. I have not found anywhere where it says the price reduction is on more than vials. Can you provide a link? I have been looking. I did see them say they may reduce other insulins in the future - Ha! Sure they will - not. Now that the SSM is suspended they will make up any commercial $35 insulin through increased Medicare billing on their other insulin products. As far as MNKD saying afrezza is insulin - I have said for years they have to work on their marketing. The first thing they need to do is get rid of the 4u/8u/12u and call them small medium and large. This is especially true if they get on the 2024 formularities and Abbott/Dexcom can convince GPs to prescribe afrezza as an add-on to all the Meidcare T2s for corrections so they can sell CGMs. And you are right afrezza is "just human insulin - like a healthy pancreas". Its the natural approach to diabetes care. The spreadsheet shows what percentage of insulin is made up by older insulin, Novolog/Novorapid, and what is made up by the newer insulin, Fiasp. The point was that reducing the price of the older insulin is far more important than reducing the price of the new. I would take a bet that they will reduce the price of Humalog before year end. They are going to be constrained by their agreements with the PBMs from acting before that (you don't want to be offering a$40 rebate on a $30 product so to speak) You are quite right about vials. I can only find vials mentioned. So I will move discounted pens to an "I expect" column. According to goodrx the current cheapest price for a vial is $44 and a pack of 5 pens is $75. If pens follow vials that price will drop to about $43. I am unclear on how exactly nthe $35 cap works. Does it happen automatically, or do I need a card? I am not opposed to tee-shirt sizing the doses because the current doses are misleading. At the very least the dosing label needs to change and that's in the works. My suspicion is that they will go with the double and round down approach. I would like to see a larger dose than 12u as well. Abbott and Dexcom are not going to push Afrezza, they are focused on getting approval for the non-insulin Type 2 people. There is already discussion about that and it's a much bigger market.
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Post by agedhippie on Mar 4, 2023 20:06:10 GMT -5
Aged - do not think of afrezza as insulin. It is not. Just like a GLP1 is not insulin, the body uses afrezza much different than every other subq insulin. Afrezza is in a class all by itself. Also, don't get fooled with the Lilly head fake. They only reduce their older vial insulins. It was a great move to stop Congress in its tracks. It was also a great opportunity for a bear raid on MNKD before the CMS CGM announcement. ... Read the sheet I linked before you jump to conclusions. Novolog/Humalog revenue is nearly an order of magnitude higher than the newer insulins. This is a good thing for diabetics since most (including me) use those older insulins. Also it's all formats and not just vials. As to "do not think of Afrezza as insulin. It is not" - the FDA says it is, even Mannkind say that it is. What Afrezza does is get into the bloodstream fast, and once there it's just human insulin.
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Post by agedhippie on Mar 4, 2023 19:52:29 GMT -5
Isn’t mnkd / working on 92% margins. It’s market share not price reduction from Lilly That's Gross Margin which means that revenue matters - you can have whatever gross margin you want if that's margin on low revenue. You SG&A will eat you alive in that case.
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Post by agedhippie on Mar 4, 2023 16:23:21 GMT -5
Sp dropped due to Lilly or because Mike's selling? Coincidence? It's completely the Lilly announcement. Lilly just reset the price of insulin. It's going to take a year or so to ripple through but by then insulin will cost about 30% of what it does today. The market knows that NVO, LLY, and SNY can make money at that price, but can Mannkind? They don't think so and what you saw was the market discounting Afrezza revenue with the resulting knock on the share price. To put this in perspective; from NVO data the revenue of the diabetes care division is 140B DKK (roughly $20B), and discounting all US insulin by 70% reduces that to 131B DKK (about $18.7B) That's why the NVO share price didn't move even though they are going to have to follow suite. For Mannkind the Afrezza revenue most definitely is significant, and entirely with the scope of the discount hence the drop. For those who are interested the numbers are all in this spreadsheet - www.novonordisk.com/content/dam/nncorp/global/en/investors/pdfs/financial-results/2022/Q4-2022-financial-data.xlsx
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Post by agedhippie on Mar 3, 2023 15:32:20 GMT -5
Isn't this is for beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 or level 3 hypoglycemic events? Is this for the once daily use of insulin vs use of mealtime insulin which Robert Ford was interviewed about? Where does it say that? How many non-insulin T2s are seeing these type of hypos and what from - sulfonylureas and TZDs? Thats another reason to get them on afrezza. I would think this is a small number but I have no idea. Look at the Revision History Information, and it gives the changes. The literal text has this as the current version that matters: The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump;becomes: The beneficiary is insulin-treated;This allows Type 2 on basal on ("insulin treated") to get a CGM. The criteria 4B you cited is also new. There are quite a lot of things that can cause hypos without involving insulin or diabetes and this LCD covers those cases as well.
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Post by agedhippie on Mar 3, 2023 9:57:59 GMT -5
I don't have the 2024 bid package. As you said rightly said earlier it's not out yet, and I haven't found a bootleg copy The two drug rule is covered in the Medicare part D manual under 30.2.1 - Formulary Categories and Classes: Each category or class must include at least two drugs (unless only one drug is available for a particular category or class, or only two drugs are available but one drug is clinically superior to the other for a particular category or class), regardless of the classification system that is utilized. The two drug minimum requirement must be met through the provision of two chemically distinct drugs.There is a carve out for protected class drugs, but diabetes is not a protected class. That's why if you look at Medicare formularies you will find two of everything! The example I gave earlier of RAA, basal, etc. is from one of the formularies which seems to have done a deal with Novo Nordisk as they had two of their products for each category...
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Post by agedhippie on Mar 2, 2023 22:28:04 GMT -5
Uncle Sam indirectly through what the insurance company bids to supply Plan D for CMS. The insurance companies get a price from the insulin vendor and then calculate their cost and risk and put a bid in to CMS for the contract. If awarded the insurance company manages the coverage and assumes the risk from CMS. Since the 2023 bids were in prior to the Inflation Reduction Act being passed CMS is collecting the costs and providing a rebate to the insurance companies. For 2023 only forms "vial and pen" where included in the bid package. For 2024 the bid packages which go out this month are suppose to include "vial, pen and inhaled". Hopefully Mike has kept a close eye on this so no one "accidently" removed the word "inhaled". Nobody is going to remove the word inhaled. Insulin may be provided in those formats, not must. The trick is that the cap applies to covered insulin products, and a covered product is defined as one that is in the insurers formulary. It's still up to the insurer to define their formulary and submit it to CMS for approval. All the CMS requires is that in the formulary there are two insulins in each class (RAA, basal, Human R, Human N) covered and those can be provided by the same manufacturer (Fiasp and Novolog) to meet the RAA category, or Novolin R and Humulin R to meet the human insulin category.
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Post by agedhippie on Mar 2, 2023 20:42:15 GMT -5
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Post by agedhippie on Mar 2, 2023 10:23:30 GMT -5
Effective January 1, 2023, out-of-pocket costs for insulin are capped at $35 per monthly prescription among Medicare Part D enrollees under the Inflation Reduction Act (IRA). A similar cap takes effect in Medicare Part B on July 1, 2023.Jan 24, 2023 Lilly is separately capping it's insulin (maybe not their new RAA though) prices at $35, not just with Medicare.
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Post by agedhippie on Mar 2, 2023 9:47:18 GMT -5
[Disclaimer: pure speculation and guesses] The $35 cap is per month not per quantity. This could be a good loophole for mnkd. We don't know for certain but if a person used afrezza for all of their mealtime insulin, the cost to mnkd for that quantity is probably more than $35/month. However, if a person used afrezza as a supplemental insulin for stubborn highs, then it is possible that this quantity of insulin costs mnkd less than $35/month. Does this make any sense or is this just nonsense? That makes sense. Didn't Mannkind offer a capped insulin cost at one point? They could just use that with a new price point.
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