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Post by morfu on May 18, 2019 17:01:00 GMT -5
The chart says it all doesn’t it? It’s beautiful. Thanks Have you taken that linear line and projected when we'll reach the $9M or so mark that would be required for profitability based on Afrezza revenue? Have you noticed the lack of growth in NRx? When you say it says it all, what is it saying to you? To me it says that there are significant problems getting new docs to start using Afrezza though we have some small base that are regularly using Afrezza, and if the size of that base remains stagnant as it has been recently it will be close to 3 years before Afrezza alone would result in cash flow positive. >> Have you noticed the lack of growth in NRx? Well, for a linear rise in revenue we only need a constant NRx (not quite as with the increased number of users, there is an increasing number of users discontinuing Affrezza, for whatever reason) >> projected when we'll reach the $9M or so Estimated by eye, this linear trend adds about 2Mil$/year, so your 9Mil per month would be reached in about 2.25 years.
Of course this chart does not account for other revenues like UTHR, Brazil, non-adults and so on And your 9Mil$/month is a rough estimate
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Post by ktim on May 19, 2019 9:42:05 GMT -5
"The good news is we know the root cause which is the current SOCs." The bad news is the only way to change this is with a clinical study that mnkd can't afford and doesn't seem to be interested in. (IMHO) I would think they want to do the studies, but simply don't want to admit to shareholders they want/need to but can't afford it. |
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Post by mnholdem on May 19, 2019 9:56:03 GMT -5
Sure gathers a decent amount of interest in a run of the mill 24hr. period.....so when you read comments like "I doubt a few posters can really make a difference on this stocks s/p" between here and stocktwits etc. think of average daily volume and think again. Think about certain posters/members that have chimed in with comments from time to time and why they spend time daily reading/surveying the board and putting in their two cents, etc. Sure there are members that have come and gone over the years but it's the amount/number of "guests" so to speak that stop by on a daily basis that fascinates me....today was a pretty avg. day, unless of course there are a lot of people that were checking in on scripts  Users Online in the Last 24 Hours
5 Staff, 359 Members, 1,136 Guests.
Members
Total Members: 3,424It is an amazing forum. If interested, member can go to the Members page and sort by Date Registered (just click on that column header. You can reverse the sort order by clicking the column header again). It's amazing how many of the pioneers of this forum still actively participate in discussions. Total Threads: 10,551 Total Posts: 174,503  |
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Post by Deleted on May 19, 2019 10:34:56 GMT -5
"The good news is we know the root cause which is the current SOCs." The bad news is the only way to change this is with a clinical study that mnkd can't afford and doesn't seem to be interested in. (IMHO) I would think they want to do the studies, but simply don't want to admit to shareholders they want/need to but can't afford it. OR....let the new Partner handle all of the SOC studies? |
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Post by goyocafe on May 19, 2019 10:42:27 GMT -5
I would think they want to do the studies, but simply don't want to admit to shareholders they want/need to but can't afford it. OR....let the new Partner handle all of the SOC studies? Per Kendall, (paraphrasing) Forget the studies, they just have to try it to see that it works. (End paraphrasing) That’s what I call capitulation. |
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Post by sayhey24 on May 19, 2019 18:04:44 GMT -5
"The good news is we know the root cause which is the current SOCs." The bad news is the only way to change this is with a clinical study that mnkd can't afford and doesn't seem to be interested in. (IMHO) I would think they want to do the studies, but simply don't want to admit to shareholders they want/need to but can't afford it. Its my understanding they are repeating the Affinity 1 and 2 studies for India except with CGMs and proper titration this time. You can't ask for more than that. Things take time but in the interim Dr. Kendall will continue to lay the foundation with the lost studies with more to come at ADA2019. I expect the one study will show T2 progression stopped. Along with the 118 study that about covers all bases for T2s. |
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Post by agedhippie on May 19, 2019 20:03:53 GMT -5
I would think they want to do the studies, but simply don't want to admit to shareholders they want/need to but can't afford it. Its my understanding they are repeating the Affinity 1 and 2 studies for India except with CGMs and proper titration this time. You can't ask for more than that. Things take time but in the interim Dr. Kendall will continue to lay the foundation with the lost studies with more to come at ADA2019. I expect the one study will show T2 progression stopped. Along with the 118 study that about covers all bases for T2s. Is there any way to be sure of those trials? I would have thought that Cipla would want to avoid using CGMs on cost grounds. Also since they are the equivalent of phase 3 trials they are usually very conservative with those because of the stakes (a bad trial and you cannot launch the drug, whereas a bad result in a later trial is just inconvenient). |
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Post by mnkdfann on May 19, 2019 21:18:42 GMT -5
Its my understanding they are repeating the Affinity 1 and 2 studies for India except with CGMs and proper titration this time. You can't ask for more than that. Things take time but in the interim Dr. Kendall will continue to lay the foundation with the lost studies with more to come at ADA2019. I expect the one study will show T2 progression stopped. Along with the 118 study that about covers all bases for T2s. Is there any way to be sure of those trials? I would have thought that Cipla would want to avoid using CGMs on cost grounds. Also since they are the equivalent of phase 3 trials they are usually very conservative with those because of the stakes (a bad trial and you cannot launch the drug, whereas a bad result in a later trial is just inconvenient). In the last earnings call (May 7), Mike talked about the trials in India. He did not mention CGMs. In fact, as I understand it, he said the design was still being discussed. Of course, he may have mentioned CGMs elsewhere, I dunno. Sounds like the trial details are still a work in progress, though. seekingalpha.com/article/4261036-mannkind-corporation-mnkd-ceo-michael-castagna-q1-2019-results-earnings-call-transcript?part=singleMichael Castagna Yes. We believe it will be a few hundred patients, type II, and we're literally discussing as we speak. We're trying to get to better dosing in type II. We know from our Phil Levin study that will be coming out that the dosing in that was a way to standardize insulin titration and that's a big focus for us, is to make it very easy for prescribers to titrate patients who are naive to insulin or switching over to insulin. And I think that's the beauty of the Indian trials, we will be able to do a study probably the way we wish we could have done six, seven years ago on our last study with proper dosing and proper titration, because we know in that particular original pivotal trial, it took docs about 12 weeks to titrate up to the effective dose and even then we'd say it wasn't effective, because they had to stop titrating at the end of that period. We're trying to not repeat those mistakes in the Indian design and so far, we feel very good with our partner Cipla in that trial design and execution. We will be ready to start that trial. |
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Post by agedhippie on May 19, 2019 22:19:59 GMT -5
Is there any way to be sure of those trials? I would have thought that Cipla would want to avoid using CGMs on cost grounds. Also since they are the equivalent of phase 3 trials they are usually very conservative with those because of the stakes (a bad trial and you cannot launch the drug, whereas a bad result in a later trial is just inconvenient). In the last earnings call (May 7), Mike talked about the trials in India. He did not mention CGMs. In fact, as I understand it, he said the design was still being discussed. Of course, he may have mentioned CGMs elsewhere, I dunno. Sounds like the trial details are still a work in progress, though. seekingalpha.com/article/4261036-mannkind-corporation-mnkd-ceo-michael-castagna-q1-2019-results-earnings-call-transcript?part=singleMichael Castagna Yes. We believe it will be a few hundred patients, type II, and we're literally discussing as we speak. We're trying to get to better dosing in type II. We know from our Phil Levin study that will be coming out that the dosing in that was a way to standardize insulin titration and that's a big focus for us, is to make it very easy for prescribers to titrate patients who are naive to insulin or switching over to insulin. And I think that's the beauty of the Indian trials, we will be able to do a study probably the way we wish we could have done six, seven years ago on our last study with proper dosing and proper titration, because we know in that particular original pivotal trial, it took docs about 12 weeks to titrate up to the effective dose and even then we'd say it wasn't effective, because they had to stop titrating at the end of that period. We're trying to not repeat those mistakes in the Indian design and so far, we feel very good with our partner Cipla in that trial design and execution. We will be ready to start that trial. I thought afterwards that I could check for myself so I went and had a look at the India trials database ( ctri.nic.in for those who are interested) and there is nothing filed yet so I suspect we are some time away from clearance in India. I don't think the CGM part is going to happen looking at other insulin trials. That makes sense in a trial since you need everyone to be on the technology the end patients will be using so there are no hidden dependencies, and CGMs for Type 2s in India are not going to be common. |
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Post by mnkdfann on May 19, 2019 22:25:45 GMT -5
I thought afterwards that I could check for myself so I went and had a look at the India trials database ( ctri.nic.in for those who are interested) and there is nothing filed yet so I suspect we are some time away from clearance in India. I don't think the CGM part is going to happen looking at other insulin trials. That makes sense in a trial since you need everyone to be on the technology the end patients will be using so there are no hidden dependencies, and CGMs for Type 2s in India are not going to be common. Do the powers that be in America generally give credence to trials in other parts of the world, and in particular India? I mean, assuming the trial goes well, would the FDA allow the Afrezza label to be changed based on this new trial, and would the ADA be likely to change the SOC? |
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Post by parrerob on May 20, 2019 3:19:48 GMT -5
Have you taken that linear line and projected when we'll reach the $9M or so mark that would be required for profitability based on Afrezza revenue? Have you noticed the lack of growth in NRx? When you say it says it all, what is it saying to you? To me it says that there are significant problems getting new docs to start using Afrezza though we have some small base that are regularly using Afrezza, and if the size of that base remains stagnant as it has been recently it will be close to 3 years before Afrezza alone would result in cash flow positive. >> Have you noticed the lack of growth in NRx? Well, for a linear rise in revenue we only need a constant NRx (not quite as with the increased number of users, there is an increasing number of users discontinuing Affrezza, for whatever reason) >> projected when we'll reach the $9M or so Estimated by eye, this linear trend adds about 2Mil$/year, so your 9Mil per month would be reached in about 2.25 years. Of course this chart does not account for other revenues like UTHR, Brazil, non-adults and so on And your 9Mil$/month is a rough estimate
That's not correct.... I believe that to reach the 9 million $ / month (for our break even) We need to sale about 18 million $ / month. We will need much more then 2,25 years for the break even.... That's the reason why we absolutely need to increase NRX to have exponential trend.... If linear trend will continue we will need much much more then 30-50 million $ considering that revenues from UTHR will start in 2021 and could be 20-30 million $ / year may be in 2022. We absolutely need to increase NRX in US and to start Brazil, Australia and India as soon as We can at least to improve Afrezza production and to reduce related costs.... |
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Post by morfu on May 20, 2019 4:27:28 GMT -5
>> Have you noticed the lack of growth in NRx? Well, for a linear rise in revenue we only need a constant NRx (not quite as with the increased number of users, there is an increasing number of users discontinuing Affrezza, for whatever reason) >> projected when we'll reach the $9M or so Estimated by eye, this linear trend adds about 2Mil$/year, so your 9Mil per month would be reached in about 2.25 years.
Of course this chart does not account for other revenues like UTHR, Brazil, non-adults and so on And your 9Mil$/month is a rough estimate
That's not correct.... I believe that to reach the 9 million $ / month (for our break even) We need to sale about 18 million $ / month. We will need much more then 2,25 years for the break even....
That's the reason why we absolutely need to increase NRX to have exponential trend....
If linear trend will continue we will need much much more then 30-50 million $ considering that revenues from UTHR will start in 2021 and could be 20-30 million $ / year may be in 2022.
We absolutely need to increase NRX in US and to start Brazil, Australia and India as soon as We can at least to improve Afrezza production and to reduce related costs....
>> That's not correct... Well.. every model has its limitations and every reader can have his/her opinion, but assuming a linear trend it will take a bit more than 2 years to reach 9mil$/month revenue.
>> If linear trend will continue we will need much much more then 30-50 million $
Currently, Mannkind already had more than 20Mil$ revenue this year, so your numbers seem awfully pessimistic. if the linear trend continues like that, we should get a revenue above 60mil
this year and that is for adults in USA alone. >> We need to sale about 18 million $ / month.
And I think peppy mentioned somewhere that the earning/revenue ratio is about 0.47 these days, so I guess, a revenue of 9mil$/month from that trend is too low, but 18mil$/month is way too high.
If we generate revenue from other sources, we could go green before the two years.
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Post by sayhey24 on May 20, 2019 5:40:55 GMT -5
Is there any way to be sure of those trials? I would have thought that Cipla would want to avoid using CGMs on cost grounds. Also since they are the equivalent of phase 3 trials they are usually very conservative with those because of the stakes (a bad trial and you cannot launch the drug, whereas a bad result in a later trial is just inconvenient). In the last earnings call (May 7), Mike talked about the trials in India. He did not mention CGMs. In fact, as I understand it, he said the design was still being discussed. Of course, he may have mentioned CGMs elsewhere, I dunno. Sounds like the trial details are still a work in progress, though. seekingalpha.com/article/4261036-mannkind-corporation-mnkd-ceo-michael-castagna-q1-2019-results-earnings-call-transcript?part=singleMichael Castagna Yes. We believe it will be a few hundred patients, type II, and we're literally discussing as we speak. We're trying to get to better dosing in type II. We know from our Phil Levin study that will be coming out that the dosing in that was a way to standardize insulin titration and that's a big focus for us, is to make it very easy for prescribers to titrate patients who are naive to insulin or switching over to insulin. And I think that's the beauty of the Indian trials, we will be able to do a study probably the way we wish we could have done six, seven years ago on our last study with proper dosing and proper titration, because we know in that particular original pivotal trial, it took docs about 12 weeks to titrate up to the effective dose and even then we'd say it wasn't effective, because they had to stop titrating at the end of that period. We're trying to not repeat those mistakes in the Indian design and so far, we feel very good with our partner Cipla in that trial design and execution. We will be ready to start that trial. Aged - why would you want to save a few pennies on CGM's when the results would be worth $Billions in results??? CGM, connected care and afrezza are the future but all three are available today. I have been working with several Indian groups trying to get both Libre's and afrezza into India. A similar reaction from ALL the doctors is this is a mircale. CGM's and afrezza simply floors them. |
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Post by agedhippie on May 20, 2019 8:15:24 GMT -5
In the last earnings call (May 7), Mike talked about the trials in India. He did not mention CGMs. In fact, as I understand it, he said the design was still being discussed. Of course, he may have mentioned CGMs elsewhere, I dunno. Sounds like the trial details are still a work in progress, though. seekingalpha.com/article/4261036-mannkind-corporation-mnkd-ceo-michael-castagna-q1-2019-results-earnings-call-transcript?part=singleMichael Castagna Yes. We believe it will be a few hundred patients, type II, and we're literally discussing as we speak. We're trying to get to better dosing in type II. We know from our Phil Levin study that will be coming out that the dosing in that was a way to standardize insulin titration and that's a big focus for us, is to make it very easy for prescribers to titrate patients who are naive to insulin or switching over to insulin. And I think that's the beauty of the Indian trials, we will be able to do a study probably the way we wish we could have done six, seven years ago on our last study with proper dosing and proper titration, because we know in that particular original pivotal trial, it took docs about 12 weeks to titrate up to the effective dose and even then we'd say it wasn't effective, because they had to stop titrating at the end of that period. We're trying to not repeat those mistakes in the Indian design and so far, we feel very good with our partner Cipla in that trial design and execution. We will be ready to start that trial. Aged - why would you want to save a few pennies on CGM's when the results would be worth $Billions in results??? CGM, connected care and afrezza are the future but all three are available today. I have been working with several Indian groups trying to get both Libre's and afrezza into India. A similar reaction from ALL the doctors is this is a mircale. CGM's and afrezza simply floors them. Why would you want to save pennies by not using CGMs? Because when Afrezza is released it will be used with meters and not CGMs. A later trial could be done to see the impact of CGM vs. meters, but not for the acceptance trial. Plus this trial is paid for by Cipla so they are going to want to keep their costs down and giving people CGMs with training and support is going to be more than pennies. |
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Post by Clement on May 20, 2019 8:23:58 GMT -5
Is it possible that Cipla's plan for Afrezza is a premium market? In that case, CGMs and Afrezza could go together. And a trial (for that premium end-market) could include CGMs and Afrezza.
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