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Post by agedhippie on Feb 5, 2024 17:55:00 GMT -5
Isn't buying by management supposed to give the pps a nice boost? To be honest though, unless they are spending millions it doesn't really make a difference.
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Post by agedhippie on Feb 4, 2024 18:42:00 GMT -5
If Marks concept hold us accountable to just 15% that’s a tough one / but if he take 15% on what we determine is a fair price for us I would think that would be great . I am pretty sure he would want the price to the patient to match LillyDirect or why would he not just leave it to Lilly? (Lilly cash price is $35 per prescription, not per box.)
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Post by agedhippie on Feb 4, 2024 18:39:02 GMT -5
... Costplusdrugs typical model is the manufacturer adds 15% and Mark adds 15%. If afrezza total cost is $30, MNKD would get $4.50 profit which is not much but what is the goal over the next 2 years? While getting $750 a box sounds great, if you are only selling 800 boxes and not expanding the user base is this really working? Right now we need to get to the 25-50k base which Bill from VDex suggested. I do think that Mark Cuban running around on a bunch of business and TV talk shows with his hair on fire pumping afrezza would sure not hurt. How many boxes of afrezza could be sold at $39? I would think a lot more than 800, especially if you have Cuban as the pitch boy explaining he has a near cure for T2 diabetes. While this is a nice idea it is not commercially viable and Mike would be finally be fired by even this BoD if he tried it. The BoD want the endocrine division to breakeven, not make an epic loss. My feeling is that the BoD have moved on from Afrezza and have it in care and maintenance mode.
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Post by agedhippie on Feb 4, 2024 15:10:58 GMT -5
Thanks Aged. But, there's no threshold for an acceptable percentage of patients coughing with Yutrepia from an FDA perspective? If it was 50%, would the FDA be ok with that? The FDA will not care about the cough (other than requiring it on the label as a side effect) unless it impacts the outcome. You could have a 100% and it would still be approved if it provided the outcome. The FDA is concerned with safety and efficacy, it will leave the acceptability of the side effects to the patient (see GLP-1 for weight loss as an example!)
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Post by agedhippie on Feb 4, 2024 12:02:18 GMT -5
Aged, UTHR likes to use in their presentation slides that Yutrepia's delivery is inferior because the majority of the dose does not go where it needs to with deep penetration into the lungs and instead it gets stuck in the back of the throat. How did LQDA get this passed with the FDA and do you think this is a legitimate talking point for UTHR? Comparatively speaking, Yutrepia is documented with higher % cough compared to Tyvaso DPI. Thoughts? That's an easy question. It got past the FDA because it delivers the required outcome, that's all the FDA cares about. How much is stuck in the throat is irrelevant if the drug works. It's legitimate, but weak argument as the efficiency is never going to be a factor with doctors but you may as well throw it out there anyway. If I was UTHR I would probably use it, but with no real expectation of success. How much higher will the cough discontinuation rate be for Yutrepia than Tyvaso DPI in the real world as opposed to trial? Nobody will know until it launches.
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Post by agedhippie on Feb 4, 2024 10:52:38 GMT -5
Nice try. I’ve read many of the FDA guidelines for advertising and they don’t require anything like saying “only 39% of each dosage goes into the patient’s lungs”. That is also the same fundamental error that gets made about Yutrepia. The efficiency is irrelevant if you can still achieve a therapeutic dose. There is no prize for minimizing the API used, only for getting desired outcome. Afrezza is a lot less efficient than sub-q if you just look at quantity of insulin used, but that's irrelevant because you can still achieve the desired outcome. This is why you never see professionals using the efficiency argument.
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Post by agedhippie on Feb 4, 2024 10:17:47 GMT -5
Buy a boat and cut out the middle man On the supply side that's what is happening. For example CVS Health owns the insurer, Aetna, the PBM, Caremark, and the pharmacy, CVS pharmacy. The big insurers have concluded that they can buy back the PBM for efficiency (plus make money as a PBM to smaller insurers) and so we see Cigna and Express Scripts, and United Health Care and Optum Rx. The problem with selling direct is the pharmacy licenses needed to dispense drugs, and all the paper processing overhead. It's why programs like LillyDirect say they are DTC, but really they are DTC with Lilly paying EVERSANA to handle the prescriptions, and TruePill to provide the logistics.
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Post by agedhippie on Feb 4, 2024 9:54:18 GMT -5
... b) The PBM has just paid $1200 for the drug and will get $450 back as co-pay leaving them $750 out of pocket. c) The patient arrives with their $35 co-pay card reducing their cost from $450 to $35 with Mannkind picking up the $415 difference. d) MNKD have just sold Afrezza at $1200 - $415 = $785 which is a lot more than it cost them to make, and more to the point it made a sale they otherwise may well not have got because of co-pay cost. ... Where is the insurance company in all of this and what are they paying and to who? Who is paying the fee to the pharmacy? In the above the pharmacy is paying the PBM $35 and MNKD $415? Without the card is the Pharmacy paying $450 to the PBM? Is there any good reason MNKD can not sell direct like Lilly is doing? I got the feeling something happened which spooked Mike when he was selling for $99. I am not sure what it is but I would like to know. The insurance company has subcontracted managing the pharmacy benefits to the PBM who will invoice them for the cost of drugs supplied amongst other things. The pharmacy is only a conduit so while it accepts the co-pay from the person it passes that straight through to the PBM. In the example here the card co-pay is $35, but the PBM wants $450 so MNKD pays the $415 difference to the pharmacy who passes the $450 co-pay to the PBM. MNKD does sell direct just like Lilly does. They both use 3rd party pharmacy service companies to handle this. These service companies have the necessary pharmacy licenses in all the states and handle the paperwork and logistics.
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Post by agedhippie on Feb 3, 2024 10:18:20 GMT -5
Let me give this a shot and its probably totally wrong 1. lets say the wholesale price is $300 2. list is $538 3. co-pay is $250 4. pharmacy would normally bill the insurer $288 ($538 - $250) in this case 1. co-pay is $35 2. pharmacy bills the insurer $288 3. pharmacy bills MNKD $215 ($250 - $35) 4. MNKD clears $85 vs $300 That's close. Lets use bigger numbers since it's clearer then taking GoodRx list price for a titration pack. 1) wholesale is $1200 (a random number, but I suspect it's close) 2) list is $2100 3) co-pay is $450 The pharmacy can be taken out of the equation because they are paid a fee to dispense rather than a margin via reimbursement. That's a can of worms on it's own but not relevant at the moment. So we have: a) The PBM get a commission for negotiating the $2100 list down to $1200. This is why list prices are simultaneously so high and largely a fantasy as the pharma has to raise the list price so the PBM can make a bigger commission on the difference between the list price and the actual price. The Symphony data includes the average actual price (WAC). This is also why Lilly could drop their insulin price from hundreds to tens of dollars and still make the same profit. b) The PBM has just paid $1200 for the drug and will get $450 back as co-pay leaving them $750 out of pocket. c) The patient arrives with their $35 co-pay card reducing their cost from $450 to $35 with Mannkind picking up the $415 difference. d) MNKD have just sold Afrezza at $1200 - $415 = $785 which is a lot more than it cost them to make, and more to the point it made a sale they otherwise may well not have got because of co-pay cost. The PBM would rather supply RAA at $30, get a $35 co-pay and make a profit (it's not quite that simple since the co-pay almost certainly covers more than one box so there will likely be a small cost to the PBM.) The cost to the patient is the same in both cases, the cost to the provider definitely is not. By subsidizing the more expensive drug the pharma is inducing (bribing in CMS terms) the patient to ignore the drug cost to the pharma's benefit. This is why you cannot use these cards with Medicare, it's a kickback and that's illegal under the Anti-Kickback Statue (AKS) for Federal health care, but that doesn't apply to commercial plans. There is jail time attached to AKS so pharmas tend to tread very carefully around that area.
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Post by agedhippie on Feb 2, 2024 17:58:33 GMT -5
Can someone explain to me why this is so convoluted? Why can't MNKD just set the price to $35 and stop all this nonsense? In the end DaisyZ is paying $35 but few are going to pay $538 a box. I keep hearing margins blah blah blah but they are already selling it for $35. This just seems crazy. MNKD is getting paid much more than $35. Insurance is paying a significant amount. MNKD is just subsidizing part of the patients co-pay. ^This. MNKD (and lots of other pharmas) subsidize the patient because they can make up a lot of the difference by charging the insurer more. It's one reason these plans are not available on government programs like Medicare as I understand it since the anti-kickback provision makes the discount card a bribe since as the insurer is giving you a kickback if you buy the drug you otherwise would not buy. The insurers have mechanics to limit the impact of these cards (co-pay maximizers and accumulators)
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Post by agedhippie on Feb 2, 2024 14:11:13 GMT -5
Just to clarify a point that I think is a bit confusing. - Call options are a contract to supply a stock for a price at some point in the future. - Call options are divided into; - covered calls, the writer has the stock, - calls, the writer doesn't have the stock.
Calls (aka. naked calls) are the normal business of the market. They are designed to let you take a position in the market for the cost of the premium. It's a straight up bet - you think the share will go up, they think it won't so place your bet. That's a gross over-simplification because your position may well involve you in betting whether the price will move, never mind if it's up or down, or not - welcome to the world of straddles, strangles, butterflies, iron condors, ladders, and things that don't have names! These involve multiple calls and puts, both buy and ask. TLDR; Covered calls are usually a simple call, normal calls are often part of a more complex construct designed to optimize the return in a particular circumstance. And we haven't even got to Futures trading yet
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Post by agedhippie on Feb 2, 2024 10:35:55 GMT -5
Nobody will immediately buy on reading an article so the morning after is not important. The most likely outcome is that the reader puts MNKD on their watch list.
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Post by agedhippie on Feb 1, 2024 17:19:15 GMT -5
Let's hope for great execution by UTHR before LQDA comes online in March. UTHR's head start should be a useful advantage. I fully support the strategy of MNKD paying down the restrictive debt and moving the pipeline ahead. We longs have been waiting over 10 years, so another year to profitability doesn't seem like a big deal to me. I don't think LQDA will launch properly until May at the earliest. The PH-ILD exclusivity lasts until the end of March and LQDA are going to want to launch with both indications on their label. My feeling is that the FDA will delay approval until after that expires.
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Post by agedhippie on Jan 28, 2024 10:40:12 GMT -5
The problem is obviousness. The patent courts really don't like companies attempting to extend dying patents by using obvious modifications. In the LQDA case this was summed up by a question Judge Lourie asked why the use of DPI wasn't within the normal skills of the art since DPI delivery is not exactly revolutionary, in which case the '793 was just a rehash of the '212 patent. His whole focus was on obviousness. You could probably get a patent for a specific API on TS, but you wouldn't be protected from a different delivery mechanism using the same API even if it was also inhaled.
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Post by agedhippie on Jan 28, 2024 0:03:12 GMT -5
It sure doesn't seem from the projected revenue to 2032 that Mike is expecting some paradigm shift based on peds or India trial (at least he's not wanting to be judged against that). Incremental increase in revenue, yes, but doesn't seem anticipation of significant change in insurance coverage or SoC (beyond adding kids to the label). I would expect the pediatric approval to add about 40% to the Afrezza sales. The problem will be the insurance cover and the bias to putting kids on pumps. The pediatric group is 4 - 18 years so a 14 year range. The adult group is 18 upwards giving three times the population. The result is that to match the adult revenue you need three times as many kids on Afrezza to match the revenue Mike shared in that chart. In other words the chart actually is quite aggressive.
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