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Post by parrerob on Apr 9, 2019 4:33:12 GMT -5
Are the low double digit royalties applyed to total revenues ? Are You sure it is not on the net rev ? Hope so but not sure Thanks
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Post by gamblerjag on Apr 9, 2019 5:46:20 GMT -5
Are the low double digit royalties applyed to total revenues ? Are You sure it is not on the net rev ? Hope so but not sure Thanks I believe net revenues
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Post by anderson on Apr 9, 2019 9:16:08 GMT -5
Here's the truth... And the CEO of UTHR has stated that if TreT is approved they will move ~100% of patients to that platform. I don't know why you say here's the truth as though anything I said was factually incorrect. It may be UTHR's plan to switch 100% of Tyvaso to TreT, but that doesn't always translate over. Expecting TreT to furiously outperform Tyvaso is probably a bad assumption. My exact words were "Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. " I'm not sure how your post made that statement incorrect. Envision a scenario where a doctor prescribes Tyvaso but finds out it's discontinued. If a UTHR rep hasn't made their rounds to that doctor's office, they're not going to switch to TreT, they'll switch it to something else. That was the point of my post. UTHR is going to have to market TreT as a though it is a new drug. I won't comment too far outside of the lines but will posit this one question- if the market size is about the same, is UTHR going to aggressively market TreT to make the same amount of money (actually less since MNKD gets their cut too) they otherwise would have already? For all intents and purposes, TreT is superior to Tyvaso. But will it be indicated for more patients? Will they do another expensive superiority trial where they compare it against other medications or just let ease of use be the main driver for prescriptions? Unless I'm missing something, the studies they're doing are comparing TreT to Tyvaso as well as completing a safety trial, not comparing it to other drugs in its class. UTHR must have seen enough potential to recoup all of these costs and more, otherwise they probably wouldn't have inked the deal. I won't sit here and play armchair quarterback. Certainly UTHR has done their homework and knows how this all plays out. Just color me a little skeptical about this blowing Tyvaso out of the water for the reasons I stated above. A lot of this is riding on how aggressively UTHR markets TreT and how much they're willing to spend to ensure its success. "Maximum tolerated dose is expected to be able to deliver higher plasma concentrations above the reported data for the current commercially available inhaled treprostinil"
"Results showed that progressive dosing of TreT significantly exceeded blood concentration and exposure levels of the maximum recommended dose of Tyvaso (inhaled treprostinil; current standard of care) without causing severe adverse events."
TreT furiously outperforms Tyvaso as shown in phase 1. Denying facts doesn't change that fact.
UTHR is the standard of care in PHA. If you looked into Tyvaso you would see why they are looking for other alternative ways to dose it, but with the MNKD inhaler being able to exceed the max recommended dose easily it should replace Tyvaso. Now the question is are the other drugs out there due to the difficulty in using Tyvaso(sound familiar) or are they needed for a different purpose. If it is because of the difficulty of administering Tyvaso and the switch to TreT is being pushed by the leading PHA company the entire standard of care for PHA might change rapidly.
Also I think UTHR has compared Treprostinil to most of the other competing drugs so why would MNKD or UTHR have to do it again?
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Post by bigchungus91354 on Apr 9, 2019 9:24:56 GMT -5
Are the low double digit royalties applyed to total revenues ? Are You sure it is not on the net rev ? Hope so but not sure Thanks I sure hope net.
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Post by awesomo on Apr 9, 2019 10:03:28 GMT -5
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Post by mango on Apr 9, 2019 10:03:53 GMT -5
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Post by figglebird on Apr 9, 2019 10:51:54 GMT -5
Thank you for posting this - can you explain or further elaborate more on what we are looking at in this graph? to address the Tyvasso vs Dryvasso retention component, based on everything I can see, United is very focused on patent expiration - that said it would appear, especially in light of yesterdays Phase 3 results which had they achieved the intended outcome would have according to their ceo and Jeffries, expand Tyvasso usage via combo therapy by 10pct and EXTEND PATENT - they did not - they do make memtion of mnkds patents on trep T which exyend as far out as 15-20 yrs - w Watson entering mkt in 5yrs(possibly sooner) w generic Tyvasso, UTHR will likely be very focused on transfering over to a dpi version - which if succsessful, would be amazing and potentially paradigm shifting... That said, getting Fda approval on both device and formulation is what must happen first... I have read some of Laquidias p3 commentary on their dpi trep t which all I can say so far does not max past mcgs mnkd ts repordedly has - however I am unsure what advantage that means or how important... can any further explain how ts tyvasso would ideally improve lives ofvthose currently on tyvasso? tx
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Post by figglebird on Apr 9, 2019 11:01:31 GMT -5
Also Regarding royalties it is net - TYVASSO howver is growing steadily and consistently and would apoear to hit and or exceed a billion in sales - further uthr does make mention as a risk - mnkds financial state - contractually mnkd is responsible for enough irreplaceable components that if for somevreason mnkd were to expierence a negative bankruptcy event etc uthr woukd need to assess the cost to them etc... which is good.
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Post by pantaloons on Apr 9, 2019 11:19:21 GMT -5
I don't know why you say here's the truth as though anything I said was factually incorrect. It may be UTHR's plan to switch 100% of Tyvaso to TreT, but that doesn't always translate over. Expecting TreT to furiously outperform Tyvaso is probably a bad assumption. My exact words were "Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. " I'm not sure how your post made that statement incorrect. Envision a scenario where a doctor prescribes Tyvaso but finds out it's discontinued. If a UTHR rep hasn't made their rounds to that doctor's office, they're not going to switch to TreT, they'll switch it to something else. That was the point of my post. UTHR is going to have to market TreT as a though it is a new drug. I won't comment too far outside of the lines but will posit this one question- if the market size is about the same, is UTHR going to aggressively market TreT to make the same amount of money (actually less since MNKD gets their cut too) they otherwise would have already? For all intents and purposes, TreT is superior to Tyvaso. But will it be indicated for more patients? Will they do another expensive superiority trial where they compare it against other medications or just let ease of use be the main driver for prescriptions? Unless I'm missing something, the studies they're doing are comparing TreT to Tyvaso as well as completing a safety trial, not comparing it to other drugs in its class. UTHR must have seen enough potential to recoup all of these costs and more, otherwise they probably wouldn't have inked the deal. I won't sit here and play armchair quarterback. Certainly UTHR has done their homework and knows how this all plays out. Just color me a little skeptical about this blowing Tyvaso out of the water for the reasons I stated above. A lot of this is riding on how aggressively UTHR markets TreT and how much they're willing to spend to ensure its success. "Maximum tolerated dose is expected to be able to deliver higher plasma concentrations above the reported data for the current commercially available inhaled treprostinil"
"Results showed that progressive dosing of TreT significantly exceeded blood concentration and exposure levels of the maximum recommended dose of Tyvaso (inhaled treprostinil; current standard of care) without causing severe adverse events."
TreT furiously outperforms Tyvaso as shown in phase 1. Denying facts doesn't change that fact.
UTHR is the standard of care in PHA. If you looked into Tyvaso you would see why they are looking for other alternative ways to dose it, but with the MNKD inhaler being able to exceed the max recommended dose easily it should replace Tyvaso. Now the question is are the other drugs out there due to the difficulty in using Tyvaso(sound familiar) or are they needed for a different purpose. If it is because of the difficulty of administering Tyvaso and the switch to TreT is being pushed by the leading PHA company the entire standard of care for PHA might change rapidly.
Also I think UTHR has compared Treprostinil to most of the other competing drugs so why would MNKD or UTHR have to do it again?
Some questions that come to mind regarding TrepT vs. Tyvaso: 1) Have the adverse effects of the Technosphere molecule been assessed in patients with PAH? A brief search through the literature did not yield anything regarding this aspect. It is not surprising, however, since that is what the Phase III trial is intended to address. I do not suspect the Technosphere delivery vehicle to be an issue for PAH patients, but again, data to support this claim would be needed. 2) While serum levels of treprostinil are significantly enhanced via Technosphere vs. Tyvaso, it is theoretically possible that Technosphere impairs uptake of treprostinil to target cells within the lung (highly unlikely, in my opinion.) However, as a general principle in pharmacology, it should not be assume that serum levels of a drug necessarily correlate to delivery to the target cells (see: volume of distribution), especially when comparing two different "modes of administration" (I put this in quotes, because although TrepT and Tyvaso are both inhaled, their molecular delivery vehicles are markedly different.) I think it's reasonable to be optimistic of the superiority of TrepT but clearly, the Phase III trial is specifically designed to more definitively assess this and hence why it is required.
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Post by mango on Apr 9, 2019 11:56:35 GMT -5
Thank you for posting this - can you explain or further elaborate more on what we are looking at in this graph? to address the Tyvasso vs Dryvasso retention component, based on everything I can see, United is very focused on patent expiration - that said it would appear, especially in light of yesterdays Phase 3 results which had they achieved the intended outcome would have according to their ceo and Jeffries, expand Tyvasso usage via combo therapy by 10pct and EXTEND PATENT - they did not - they do make memtion of mnkds patents on trep T which exyend as far out as 15-20 yrs - w Watson entering mkt in 5yrs(possibly sooner) w generic Tyvasso, UTHR will likely be very focused on transfering over to a dpi version - which if succsessful, would be amazing and potentially paradigm shifting... That said, getting Fda approval on both device and formulation is what must happen first... I have read some of Laquidias p3 commentary on their dpi trep t which all I can say so far does not max past mcgs mnkd ts repordedly has - however I am unsure what advantage that means or how important... can any further explain how ts tyvasso would ideally improve lives ofvthose currently on tyvasso? tx The first one is a PK measurement illustrating the peak serum concentrations of TreT and Tyvaso with escalating doses. TreT Phase 1 participants experienced no adverse events up to 180mcg dose. 54mcg of Tyvaso is the current total daily recommended dose—which requires multiple dosing sessions throughout the day and takes a long time to complete each session—with TreT it takes 1 or 2 inhalations and can be done anywhere, anytime and they will be evaluating 150mcg TreT for Phase 3 according to Mike, so that is 3 times the current SoC with Tyvaso in addition to much greater exposure (second pic) and less side effects. The second, also PK, is the area under the plasma concentration that was plotted of TreT & Tyvaso compared w/ time after dose...area under the curve (AUC) shows you the exposure and the clearance of the drug/dose etc.
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Post by jred on Apr 9, 2019 13:18:56 GMT -5
After seeing the news on the BEAT trial failure, I went back through the last couple of presentations. This is what I gleaned:
They have four therapies for pulmonary arterial hypertension (PAH): Remodulin (injection/intravenous), Tyvaso (inhaled), Orenitram (extended release) and Adcirca (tablets). From page 65 of 10K:
Net product sales Percentage Change
2018 2017 2016 2018 v. 2017 2017 v. 2016 Remodulin 599.0 670.9 602.3 (10.7 )% 11.4 % Tyvaso 415.2 372.9 404.6 11.3 % (7.8 )% Adcirca 323.7 419.7 372.2 (22.9 )% 12.8 % Orenitram 205.1 185.8 157.2 10.4 % 18.2 % Unituxin 84.8 76.0 62.5 11.6 % 21.6 %
TreT is only related to the Tyvaso revenues - $415million in 2018.
According to the UTHR press release on 4/8 the BEAT trail used a combination of Tyvaso and Esuberaprost tablets. Based on the failure, UTHR is discontinuing Esuberaprost development.
IMO this in no way effects UTHR's continued pursuit in getting Ralinepag approved. Ralinepag is the ARNA drug for PAH that UTHR is licensing for $1.2billion plus single digit royalties.
However when asked about TreT and the BEAT trial at the recent Oppenheimer Healthcare Conference, CEO Martine Rothblatt had this to say at the 25:37 mark (sorry I couldn't find a transcript so this is my transcription)
"Once we get FDA approval for the Mannkind product, which we call Technosphere, I do believe there will be a very rapid replacement of nebulizers with that dry powder inhaler. It's so small, so convenient, it's Bluetooth connects to your phone. It's really modern inhaler technology compared to 20th century inhaler technology. So whether or not BEAT is successful, I think there will be a 100% replacement of nebulizers with the Mannkind Technosphere."
I do not know how the Ralinepag development will impact the Tyvaso/TreT platform, but I agree with mango that CEO Martine Rothblatt, in Jan 2019, stated the expected growth of the $400 million in Tyvaso revenue is expected to exceed "$1 billion+ down the line."
@11:39 of webcast (sorry again - my transcription):
"Our second therapeutic platform, the Tyvaso therapeutic platform, where we are counting on this platform to double United Therapeutics in size in next few years and then again in the 2020's".
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Post by figglebird on Apr 9, 2019 14:04:12 GMT -5
thank you mango and other posters for elaborating further on this topic which I have been thinking about since uthrs discussion some weeks back whatever conference - liquidia which recently ipo'd and at one time had a partnership with glaxo one of the leading respiratory pharmaceutical companies is obviously far along and heading towards their conclusion of their face three of print trep t which essentially is being marketed for promoted as an answer to a lot of current inconveniences of tyvasso MannKind seems to be addressing with technosphere or dryvasso... there are two areas here that I find compelling.
1. we have a higher MCG tolerance then what they reported through phase 3 not by much but it's still higher.
2. way more importantly the FDA published revised guidelines with respect to dry powder inhalation and in particular dual approval and it is this area that liquidia not only mentioned as a risk factor with respect to their ability to raise financing on the device side of things, once they do seek approval from the FDA but moreover... does MannKind whethet with respect to isperse print whatever or what we might hope is the dpi shift, maintain some or any advantage via the experience of having to spend that extra billion developing cricket and ultimately get afrezza approved... these revised guidelines were obviously put into place for a reason and done so last year but if there is an advantage - and without knowing the science or process I could naively imagine several, w respect device, I again don't think it's by accident that Martine rosenblatt continues to mention blue Hale and cricket as much as anything else - again if an advantage does exist specifically on the device and the things then I think most people really discount Afrezzas valuation in ways that are frankly never tabulated
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Post by peppy on Apr 9, 2019 14:24:52 GMT -5
I don't know why you say here's the truth as though anything I said was factually incorrect. It may be UTHR's plan to switch 100% of Tyvaso to TreT, but that doesn't always translate over. Expecting TreT to furiously outperform Tyvaso is probably a bad assumption. My exact words were "Right now, we should expect TreT to replace Tyvaso's sales, assuming UTHR pushes hard and educates doctors. Whether it will extend far beyond that is unknown. " I'm not sure how your post made that statement incorrect. Envision a scenario where a doctor prescribes Tyvaso but finds out it's discontinued. If a UTHR rep hasn't made their rounds to that doctor's office, they're not going to switch to TreT, they'll switch it to something else. That was the point of my post. UTHR is going to have to market TreT as a though it is a new drug. I won't comment too far outside of the lines but will posit this one question- if the market size is about the same, is UTHR going to aggressively market TreT to make the same amount of money (actually less since MNKD gets their cut too) they otherwise would have already? For all intents and purposes, TreT is superior to Tyvaso. But will it be indicated for more patients? Will they do another expensive superiority trial where they compare it against other medications or just let ease of use be the main driver for prescriptions? Unless I'm missing something, the studies they're doing are comparing TreT to Tyvaso as well as completing a safety trial, not comparing it to other drugs in its class. UTHR must have seen enough potential to recoup all of these costs and more, otherwise they probably wouldn't have inked the deal. I won't sit here and play armchair quarterback. Certainly UTHR has done their homework and knows how this all plays out. Just color me a little skeptical about this blowing Tyvaso out of the water for the reasons I stated above. A lot of this is riding on how aggressively UTHR markets TreT and how much they're willing to spend to ensure its success. "Maximum tolerated dose is expected to be able to deliver higher plasma concentrations above the reported data for the current commercially available inhaled treprostinil"
"Results showed that progressive dosing of TreT significantly exceeded blood concentration and exposure levels of the maximum recommended dose of Tyvaso (inhaled treprostinil; current standard of care) without causing severe adverse events."
TreT furiously outperforms Tyvaso as shown in phase 1. Denying facts doesn't change that fact.
UTHR is the standard of care in PHA. If you looked into Tyvaso you would see why they are looking for other alternative ways to dose it, but with the MNKD inhaler being able to exceed the max recommended dose easily it should replace Tyvaso. Now the question is are the other drugs out there due to the difficulty in using Tyvaso(sound familiar) or are they needed for a different purpose. If it is because of the difficulty of administering Tyvaso and the switch to TreT is being pushed by the leading PHA company the entire standard of care for PHA might change rapidly.
Also I think UTHR has compared Treprostinil to most of the other competing drugs so why would MNKD or UTHR have to do it again?
This is the results their ambition trial. The trial results make the other drugs clear. www.gilead.com/-/media/files/pdfs/medicines/cardiovascular/letairis/letairis_pi.pdf
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Post by mango on Apr 9, 2019 14:38:33 GMT -5
1B$ ---------- Royalties:
10% = 100M$
15% = 150M$
-------------- Annually.
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Post by cretin11 on Apr 9, 2019 15:26:30 GMT -5
Thanks for all the research and info y'all. This could be a game changer, that revenue (even if TreT only matches Tyvaso instead of blowing it away) would go a long way towards filling in the money we're bleeding out each month on Afrezza, hopefully allowing us a longer runway for Afrezza instead of being forced into more bad deals/dilutions etc.
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