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Post by agedhippie on Oct 22, 2023 14:54:56 GMT -5
Only meal ticket we have, Tyvaso DPI, going through uncertainty and competition challenges by LQDA might be the reason mnkd sp keeps getting chopped down after good ER? The LQDA has nothing to do with the MNKD share price. That tracks UTHR and is why MNKD gets periodically hit. LQDA competition will not be priced into the UTHR share price, and by proxy MNKD, until there are enough sales to be competition so my guess would be 2024H2 at the earliest.
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Post by agedhippie on Oct 22, 2023 14:51:30 GMT -5
Aged and all. If Afrezza's price point was less than the Humalog and Novolog price point would there be more scripts even though it is labeled non-superior? I am asking the price point the insurers pay. Again IMHO, yes. This is insurance we are talking about, so it's the cheapest choice that will do the job. This is why I can get Humalog but not Novolog from my insurer, and why Afrezza isn't in the big insurers Medicare formularies for next year. To be competitive Afrezza would need to be list priced around $40 for a 90 x 12u box. If the insurer wasn't paying attention you might be able to get that up to $60 (Afrezza requires more insulin since 1u of Afrezza is weaker than 1u of RAA. This dates back to when they made the move from actual units used to an analog of the RAA units for marketing - it was the right thing to do.)
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Post by agedhippie on Oct 22, 2023 12:47:48 GMT -5
Tyvasso DPI is already on the market. The insurance company rebate has been negotiated. Any chance LQDA will be approved as non-superior? It will definitely be approved as non-inferior. These two are so close that they will end up competing on price IMHO.
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Post by agedhippie on Oct 22, 2023 6:23:11 GMT -5
The date for UTHR's oral argument is December 4th ( cafc.uscourts.gov/wp-content/uploads/OralArguments/PublicCalendar-December2023.pdf). The judgement date is probably some time in February at a guess. I doubt they will rule immediately despite speculation from LQDA. Assuming LQDA wins, which is the probable outcome given the history of these courts, the FDA will clear Yutrepia for PAH within a month or so, and for PH-ILD in March. I would expect Yutrepia to be launched around June. Contrary to some comments I have seen if UTHR loses the appeal then they cannot block LQDA from selling Yutrepia for PH-ILD since LQDA filed for that indication before UTHR got the PH-ILD patent into the Orange book (you can only block approval if the patent is already registered in the Orange book). That leaves the exclusivity period which expires in March. You can listen to the oral argument live or recorded - cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/Panel C: Monday, December 4, 2023, 10:00 A.M., Courtroom 203 22-1971 PTO EcoFactor, Inc. v. Google LLC [argued] 22-1974 DCT EcoFactor, Inc. v. Google LLC [argued] 22-2038 DCT Applied Biokinetics LLC v. CVS Pharmacy, Inc. [argued] 23-1805 PTO United Therapeutics Corporation v. Liquidia Technologies, Inc. [argued] ...
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Post by agedhippie on Oct 17, 2023 17:54:12 GMT -5
... I guess I’m counting on market equilibrium to win out in the end. Accelerated revenue growth takes care of all This is a pairs trade. When MNKD diverges from UTHR the stock gets shorted because there is no reason for it to outpace UTHR as that's the revenue source. The flipside is that if MNKD diverges below UTHR then the traders will go long. Breaking this cycle requires more significant revenue streams. MNKD is more volatile, but ultimately it reverts.
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Post by agedhippie on Oct 17, 2023 16:53:21 GMT -5
Curious. Not predicting a 'short squeeze', but could the fact that we have 53% institutional ownership contribute to, or even exacerbate, any upward price movement? The bulk of these shareholders are tracker funds making the actual share price immaterial to them as it's driven entirely by the indices. The result is that their share holding is neutral - it's doesn't help or hinder.
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Post by agedhippie on Oct 10, 2023 17:07:25 GMT -5
I believe Aged has it right. Paradoxically the $35 copay cap for insulin was MORE LIKELY to hurt Afrezza sales than help. As he said that cap applied to insulin products COVERED by the plan. Given the expense of Afrezza insurance plans would be forced to eat the increased costs resulting from a copay cap of $35. The copays for Afrezza on many plans at that time were hundreds of dollars per month. The copay cap meant the insurance plans would bear the cost above $35. They couldn’t pass those costs on to the member. So, the logical reaction is to drop Afrezza from formulary to avoid the costs. The insurance plans can do that because they can substitute other prandial insulin products (RAAs) for Afrezza. As long as Afrezza is seen as “non inferior” (ie. equivalent) to other prandial insulins insurance plans can substitute. So, what’s the work around? Same as it’s always been. We have to distinguish Afrezza, essentially creating a category of its own. I know MNKD tried to create an ultra-rapid category. Not sure what’s happened there. I think studies are necessary to make the case for Afrezza. The fact is marketplace ignorance about Afrezza hurts everyone, patients, providers and shareholders. We have to change that. ~ Bill McCullough ^ What he said. This is compounded by the way CMS sets the price it is prepared to pay which is based on what the PBM pays the pharmacy. I don't know what that will be exactly but the upper limit is $66 for a vial of Humalog (the list price, but they will get a discount) as of next year. Consequently the insurer has to eat the difference between that price and and the $1500 that Mannkind will charge for Afrezza without the benefit of being able to get a big chunk back as co-pay.
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Post by agedhippie on Oct 9, 2023 16:28:45 GMT -5
Its kind of sad. After last year I viewed this as a lay-up for Mike. When I heard him say "probably 2025" a few calls back it seemed to me they did not do the proper lobbying and dropped the ball. Maybe Mike did not understand how big getting coverage by these Medicare plans is. I think he does now but I think the ship had sailed and the proper lobbying was not done soon enough. We should get some great results for the kids, pump-switch and the India trial. Maybe 2024 will be the turning point and things will finally come together in 2025. I don't think this was ever a lay-up. There was nothing to make insurers more likely to cover Afrezza. As I said repeatedly, the IRA didn't mean that insurers have to cover Afrezza, and coverage is a pre-condition of the $35 cap. As of the end of the year the list price for Afrezza is going to be impressively expensive and RAA is going to be dirt cheap ($1500 vs $66). That is not going to incentivize insurance coverage when the co-pay for both insulins is $35. Expect appeals to get a lot harder.
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Post by agedhippie on Oct 9, 2023 9:45:24 GMT -5
If this is true it would be huge news but I don't think it is. It is not what was previewed by CMS a few weeks ago. Open enrollment starts 10/15 so we will know for sure next Sunday. "The only one I know of is Aetna which started in July. However Humana starts coverage in 2024 along w United." The final versions of the plans are live, no need to wait
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Post by agedhippie on Oct 9, 2023 7:49:37 GMT -5
I am also somewhat curious about here comment that Aetna covered Afrezza: I think she may be confusing access via appeal with being covered.
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Post by agedhippie on Oct 9, 2023 7:44:30 GMT -5
You made me go to Stocktwits - ugh. I think they will find they are wrong. This is the result from the Humana drug coverage search for 2024 in New York state (https://drug-pricing.apps.external.pioneer.humana.com/medicaredrugsearch/check-coverage): Attachments:
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Post by agedhippie on Oct 1, 2023 12:49:34 GMT -5
OK wait …Mike’s not selling Afrezza to the type2 market anymore. You mean the reps go in there and they say Afrezza is for type1 and here’s the patch for type2? Allowing for the transcript... This is from the Morgan Stanley conference: " But V-Go itself has been a great device. We've positioned that for type 2, so I talked about Afrezza for type 1." " So when our sales force is out there, if they're not going to write in a inhaled insulin, then you've got plenty of patients that have type 2. Let's try to help those patients. And that's really our focus, is making sure our sales force is efficient and effective, and bringing as many offerings to customers as we can." My read of that is the salesforce will push for Afrezza Type 1 market if there is resistance, but in the Type 2 if there is an resistance switch the conversation to V-Go.
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Post by agedhippie on Sept 30, 2023 15:12:49 GMT -5
... Mike now understands the dosing issue. We now have $35 Medicare coverage (with pre auths) and we have near free Medicare CGMs with any insulin. We also have the India results coming soon and if they properly dosed we should see the 1.5 - 2.0 A1c reduction Mike mentioned a few calls back. ... The Medicare coverage is already there and Mike was crystal clear on this at the Morgan Stanley conference, he sees V-Go is for Type 2, Afrezza is for Type 1. What to you expect the India results to do? They are repeating the the 175 trial so the comparison is insulin vs. nothing. I would certainly hope Afrezza could get a 1.5 - 2.0 reduction because GLP-1 analogs, which are the competitor for that step, all managed to get over 2.0 reduction last I looked. India may actually be a negative since the original aim was to increase the utilization of the Danbury plant to reduce overall production costs. Now that production capacity is needed for Tyvaso so meeting both schedules could be an issue (who do you want to upset?)
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Post by agedhippie on Sept 30, 2023 11:39:32 GMT -5
Mike's problem is the speed of evolution of pumps, he is stuck in the old days of dumb pumps because unless you keep current on the paper that where that's where the mainstream data is. It's the same with the idea that HbA1c results haven't changed much - that true if you ignore the current generation of pumps, but definitely not true if you look at pumps like the Tandem Control:IQ, Omnipod 5, or Medtronics 780G as these will all get you below that target. The current generation can hit 75%+ TIR with minimal effort and 80%+ is pretty commonplace. People aren't jumping from pump to pump for fun, it's because at this point in time each generation is noticeably better than the last so why wouldn't you change? The idea that RAA is to slow for meals is flatly wrong if you are using one of these systems (see the TIR results). The problem is that to get those results you have to be continually taking and adjusting insulin on a minute to minute basis. This is not possible for humans, but trivial for computers and pumps like AID systems. The problem with diabetes today is that people are hung up on old data in a world that is rapidly evolving. When Mike says things like HbA1c has not improved for decades it just makes him look out of touch because the people he needs to reach, who are the thought leaders, know that is no longer the case. This is double edged sword for Afrezza because the slower moving doctors will stick to what they know and the SoC (Mike's comment about the need for education), and the leaders are already onto AID and Afrezza as a rescue inhaler.
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Post by agedhippie on Sept 29, 2023 12:30:37 GMT -5
In this Cantor conference Mike mentions he has hired a new marketer and moved marketing from west coast to east coast interesting move. This conference is loaded with info. That was one of the more interesting bits for me. Mike was explaining why he thought Afrezza hadn't taken off. The chief blocker he and the advisory board see isn't safety but rather it's access. Mike's view is that Medicare fixes that, but I think it's only a partial fix. While it's going to address the people over 65 that leaves all the others who are the bulk of the meal time insulin users. The follow up was that they would put money into physician education to get Afrezza top of mind - my immediate though was what has there sales force been doing to date then? There is the concession that market has been poorly handled to date, hence the new marketer in time for pediatrics next year.
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