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Post by tlundy on Oct 3, 2019 10:13:57 GMT -5
First time I’ve heard Mike drop a “holy shit” in describing patients’ reaction to how fast Afrezza kicks in.
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Post by sweedee79 on Oct 3, 2019 10:30:57 GMT -5
Getting a new molecule partner will not move the stock as much as you think. MNKD needs to get CMS Approval. Once they get Medicare & Medicaid Approval it will open the flood gates for all insurance companies to cover Afrezza. Hopefully their new Gov't Affairs Dept. is working on it. The street is waiting patiently for approval which will bring in more revenues faster. Also after approval it will be interesting to see if Mike expands the salesforce or wait it out for PEDS Approval before getting a marketing partner. I'm on Medicare and it's not up to the CMS to "approve" Afrezza. It's up to the commercial insurance companies who offer supplemental drug coverage to Medicare recipients. My supplemental plan does offer Afrezza to Medicare recipients, with a Prior Authorization requirement. Who is your supplemental plan through?
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Post by ltta on Oct 3, 2019 11:47:53 GMT -5
I heard Mike C say "I/we feel very good about..." at least 25+ times.
I hope to "feel very good about" my investment some day!
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Post by wsulylecoug on Oct 3, 2019 11:53:49 GMT -5
I just listened to the call. I heard nothing new. Did anyone else? Some new tidbits and/or insights for me were... - MC's reference to the TS platform as the companies "secret sauce", it's the foundation and will be very important (maybe more important than Afrezza?) in the company's future. It seemed to me in the past that the company had been performing this very delicate balancing act of "where does our money go?". My takeaway is that more focused investing into the TS platform compound development now is needed for future support of Afrezza growth. I've wondered where the priority was in the past, but this provided some clarity of me. Not saying it's right or wrong, some folks have strong opinions on that, but that was just some clarity from my perspective.
- Brazil shipment is at or through customs.
- MC referred to the pediatric study more in this presentation that any other from memory. He linked it to changing the standard of care and put a 20-year time from on it. I don't think he actually meant the ADA SOC, but diabetic behavior in general once the pioneer pediatric users of Afrezza continue use in the future as adults. With P3 peds trial to start in 2020, through FDA approval and trial participants reaching adulthood...about 20 years. Can't say that number excited me much, but ultimately getting the peds approval would be huge...still a couple years out though.
- No decision has been made regarding the undisclosed UTHR molecule...despite rumors to the contrary. The molecule is scheduled to start rodent toxicity studies in Q4 or Q1-2020.
- When talking about the pipeline, MC referred to a 2-5 year time frame for receiving milestones payments from UTHR and RLS. Work continues for RLS for an FDA approved product (probably some non FDA as well?). This is the first time I can remember an actual number put on RLS milestones. It's not exactly nailed down by any means, but I think the "2" refers to UTHR and the "5" likely refers to RLS. I hope the 5 is on the conservative side.
- The Pfizer safety data for Exhubra was brought up and referred to as safety data for "inhaled insulin". We already knew it was out there but I think it was the first time presented at an investor conference. (Why did Pfizer do that?...seems odd).
- While at the conference MC met with a group of physicians and asked who was stuck on Afrezza dosing limitations with 4, 8, 12. Apparently many were and MC said "Speed trumps accuracy". Afrezza's speed of action is more important than getting the RAA injected dose down to the fraction of a unit. That was portrayed as an "Ahha" moment to them. Maybe it was, maybe it wasn't, but I like the statement "Speed trumps accuracy" and hope it is used more often and sticks. I'm no doctor and there are probably some folks who don't agree with that statement, but I think it's catchy and straight to the point.
- Interest expense has been reduced from 20 mil to 4 mill on an annual basis. Assume it will now be paid for a longer time period, but at this point in time, that move makes sense.
- Towards the end of the presentation (Slide 24) collaborative revenue...MC says "I continue to get inbound calls for the platform to put other peoples drugs on our platform".
- One question during Q&A - Regarding Technosphere - "What's lead to the inbound interest in partnering given that TS has been around for awhile?" MNKD is going to start attending conferences specifically for inhaled platforms. MC referred to one in Europe where TS had been brought up as one to watch which generated three calls. MC also referred to the increased financial stability of the company as a reason for increased interest. It was interesting that whoever brought up TS at the Europe conference had no connection to MNKD and MC didn't know who they were.
One person's perspective...
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Post by rickf on Oct 3, 2019 11:54:54 GMT -5
I heard Mike C say "I/we feel very good about..." at least 25+ times.
I hope to "feel very good about" my investment some day! I am losing faith! I fear the worst!
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Post by mango on Oct 3, 2019 12:15:17 GMT -5
Nothing new. But MC said "undisclosed molecule" with UTHR is still in play and probably moving into rodent tox studies in Q4 or Q1. (time 9:25 in the presentation) LOL! and Spencer O just said matter of factly in a recent Arena article that the deal was off, that UT passed on it. 🤣😂 (these people are stupid)
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Post by ryster505 on Oct 3, 2019 12:23:08 GMT -5
Nothing new. But MC said "undisclosed molecule" with UTHR is still in play and probably moving into rodent tox studies in Q4 or Q1. (time 9:25 in the presentation) LOL! and Spencer O just said matter of factly in a recent Arena article that the deal was off, that UT passed on it. 🤣😂 (these people are stupid) People are getting it wrong, SO did not say "matter of fact", he said "most certainly likely". Different meaning. I dont love SO, but people need to not misconstrue words here. A matter of fact could have some consequences that I know SO would not want to deal with
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Post by mango on Oct 3, 2019 12:28:17 GMT -5
LOL! and Spencer O just said matter of factly in a recent Arena article that the deal was off, that UT passed on it. 🤣😂 (these people are stupid) People are getting it wrong, SO did not say "matter of fact", he said "most certainly likely". Different meaning. I dont love SO, but people need to not misconstrue words here. A matter of fact could have some consequences that I know SO would not want to deal with Huh? This is what SO wrote. Looks like you didn’t see this huh?
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Post by nylefty on Oct 3, 2019 12:28:35 GMT -5
I'm on Medicare and it's not up to the CMS to "approve" Afrezza. It's up to the commercial insurance companies who offer supplemental drug coverage to Medicare recipients. My supplemental plan does offer Afrezza to Medicare recipients, with a Prior Authorization requirement. Who is your supplemental plan through? My plan is the GE Plan For Health For Retirees, which is for GE retirees and their families only. It's administered by United Health (with prescription drugs covered by OptumRX, which is owned by United Health). Traditional Medicare doesn't cover prescription drugs except for those given in hospitals or administered in doctors' offices. The only way Medicare patients can get prescriptions paid for at pharmacies (both traditional and online) is to buy a commercial supplemental plan.
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Deleted
Deleted Member
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Post by Deleted on Oct 3, 2019 12:43:07 GMT -5
I just listened to the call. I heard nothing new. Did anyone else? Some new tidbits and/or insights for me were... - MC's reference to the TS platform as the companies "secret sauce", it's the foundation and will be very important (maybe more important than Afrezza?) in the company's future. It seemed to me in the past that the company had been performing this very delicate balancing act of "where does our money go?". My takeaway is that more focused investing into the TS platform compound development now is needed for future support of Afrezza growth. I've wondered where the priority was in the past, but this provided some clarity of me. Not saying it's right or wrong, some folks have strong opinions on that, but that was just some clarity from my perspective.
- Brazil shipment is at or through customs.
- MC referred to the pediatric study more in this presentation that any other from memory. He linked it to changing the standard of care and put a 20-year time from on it. I don't think he actually meant the ADA SOC, but diabetic behavior in general once the pioneer pediatric users of Afrezza continue use in the future as adults. With P3 peds trial to start in 2020, through FDA approval and trial participants reaching adulthood...about 20 years. Can't say that number excited me much, but ultimately getting the peds approval would be huge...still a couple years out though.
- No decision has been made regarding the undisclosed UTHR molecule...despite rumors to the contrary. The molecule is scheduled to start rodent toxicity studies in Q4 or Q1-2020.
- When talking about the pipeline, MC referred to a 2-5 year time frame for receiving milestones payments from UTHR and RLS. Work continues for RLS for an FDA approved product (probably some non FDA as well?). This is the first time I can remember an actual number put on RLS milestones. It's not exactly nailed down by any means, but I think the "2" refers to UTHR and the "5" likely refers to RLS. I hope the 5 is on the conservative side.
- The Pfizer safety data for Exhubra was brought up and referred to as safety data for "inhaled insulin". We already knew it was out there but I think it was the first time presented at an investor conference. (Why did Pfizer do that?...seems odd).
- While at the conference MC met with a group of physicians and asked who was stuck on Afrezza dosing limitations with 4, 8, 12. Apparently many were and MC said "Speed trumps accuracy". Afrezza's speed of action is more important than getting the RAA injected dose down to the fraction of a unit. That was portrayed as an "Ahha" moment to them. Maybe it was, maybe it wasn't, but I like the statement "Speed trumps accuracy" and hope it is used more often and sticks. I'm no doctor and there are probably some folks who don't agree with that statement, but I think it's catchy and straight to the point.
- Interest expense has been reduced from 20 mil to 4 mill on an annual basis. Assume it will now be paid for a longer time period, but at this point in time, that move makes sense.
- Towards the end of the presentation (Slide 24) collaborative revenue...MC says "I continue to get inbound calls for the platform to put other peoples drugs on our platform".
- One question during Q&A - Regarding Technosphere - "What's lead to the inbound interest in partnering given that TS has been around for awhile?" MNKD is going to start attending conferences specifically for inhaled platforms. MC referred to one in Europe where TS had been brought up as one to watch which generated three calls. MC also referred to the increased financial stability of the company as a reason for increased interest. It was interesting that whoever brought up TS at the Europe conference had no connection to MNKD and MC didn't know who they were.
One person's perspective... Good summary.....I can't go in depth right now but one slide stuck out for me. Mike purposely told CF about the 4 Analysts covering MNKD and their Price Targets. He also said that when the money starts flowing in they will have to raise their targets. This is definitely the first time he has done this. Almost saying to CF....you better jump on board now before the train leaves the station. He was very confident if not cocky in mentioning when the money starts rolling in.
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Post by harryx1 on Oct 3, 2019 12:49:14 GMT -5
I just listened to the call. I heard nothing new. Did anyone else? Some new tidbits and/or insights for me were... - MC's reference to the TS platform as the companies "secret sauce", it's the foundation and will be very important (maybe more important than Afrezza?) in the company's future. It seemed to me in the past that the company had been performing this very delicate balancing act of "where does our money go?". My takeaway is that more focused investing into the TS platform compound development now is needed for future support of Afrezza growth. I've wondered where the priority was in the past, but this provided some clarity of me. Not saying it's right or wrong, some folks have strong opinions on that, but that was just some clarity from my perspective.
- Brazil shipment is at or through customs.
- MC referred to the pediatric study more in this presentation that any other from memory. He linked it to changing the standard of care and put a 20-year time from on it. I don't think he actually meant the ADA SOC, but diabetic behavior in general once the pioneer pediatric users of Afrezza continue use in the future as adults. With P3 peds trial to start in 2020, through FDA approval and trial participants reaching adulthood...about 20 years. Can't say that number excited me much, but ultimately getting the peds approval would be huge...still a couple years out though.
- No decision has been made regarding the undisclosed UTHR molecule...despite rumors to the contrary. The molecule is scheduled to start rodent toxicity studies in Q4 or Q1-2020.
- When talking about the pipeline, MC referred to a 2-5 year time frame for receiving milestones payments from UTHR and RLS. Work continues for RLS for an FDA approved product (probably some non FDA as well?). This is the first time I can remember an actual number put on RLS milestones. It's not exactly nailed down by any means, but I think the "2" refers to UTHR and the "5" likely refers to RLS. I hope the 5 is on the conservative side.
- The Pfizer safety data for Exhubra was brought up and referred to as safety data for "inhaled insulin". We already knew it was out there but I think it was the first time presented at an investor conference. (Why did Pfizer do that?...seems odd).
- While at the conference MC met with a group of physicians and asked who was stuck on Afrezza dosing limitations with 4, 8, 12. Apparently many were and MC said "Speed trumps accuracy". Afrezza's speed of action is more important than getting the RAA injected dose down to the fraction of a unit. That was portrayed as an "Ahha" moment to them. Maybe it was, maybe it wasn't, but I like the statement "Speed trumps accuracy" and hope it is used more often and sticks. I'm no doctor and there are probably some folks who don't agree with that statement, but I think it's catchy and straight to the point.
- Interest expense has been reduced from 20 mil to 4 mill on an annual basis. Assume it will now be paid for a longer time period, but at this point in time, that move makes sense.
- Towards the end of the presentation (Slide 24) collaborative revenue...MC says "I continue to get inbound calls for the platform to put other peoples drugs on our platform".
- One question during Q&A - Regarding Technosphere - "What's lead to the inbound interest in partnering given that TS has been around for awhile?" MNKD is going to start attending conferences specifically for inhaled platforms. MC referred to one in Europe where TS had been brought up as one to watch which generated three calls. MC also referred to the increased financial stability of the company as a reason for increased interest. It was interesting that whoever brought up TS at the Europe conference had no connection to MNKD and MC didn't know who they were.
One person's perspective... I don't know, maybe? ?? They should have been going to conferences the last several years. I've posted a few times to certain twitter hashtags for conferences.
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Post by boca1girl on Oct 3, 2019 12:55:01 GMT -5
I just listened to the call. I heard nothing new. Did anyone else? Some new tidbits and/or insights for me were... - MC's reference to the TS platform as the companies "secret sauce", it's the foundation and will be very important (maybe more important than Afrezza?) in the company's future. It seemed to me in the past that the company had been performing this very delicate balancing act of "where does our money go?". My takeaway is that more focused investing into the TS platform compound development now is needed for future support of Afrezza growth. I've wondered where the priority was in the past, but this provided some clarity of me. Not saying it's right or wrong, some folks have strong opinions on that, but that was just some clarity from my perspective.
- Brazil shipment is at or through customs.
- MC referred to the pediatric study more in this presentation that any other from memory. He linked it to changing the standard of care and put a 20-year time from on it. I don't think he actually meant the ADA SOC, but diabetic behavior in general once the pioneer pediatric users of Afrezza continue use in the future as adults. With P3 peds trial to start in 2020, through FDA approval and trial participants reaching adulthood...about 20 years. Can't say that number excited me much, but ultimately getting the peds approval would be huge...still a couple years out though.
- No decision has been made regarding the undisclosed UTHR molecule...despite rumors to the contrary. The molecule is scheduled to start rodent toxicity studies in Q4 or Q1-2020.
- When talking about the pipeline, MC referred to a 2-5 year time frame for receiving milestones payments from UTHR and RLS. Work continues for RLS for an FDA approved product (probably some non FDA as well?). This is the first time I can remember an actual number put on RLS milestones. It's not exactly nailed down by any means, but I think the "2" refers to UTHR and the "5" likely refers to RLS. I hope the 5 is on the conservative side.
- The Pfizer safety data for Exhubra was brought up and referred to as safety data for "inhaled insulin". We already knew it was out there but I think it was the first time presented at an investor conference. (Why did Pfizer do that?...seems odd).
- While at the conference MC met with a group of physicians and asked who was stuck on Afrezza dosing limitations with 4, 8, 12. Apparently many were and MC said "Speed trumps accuracy". Afrezza's speed of action is more important than getting the RAA injected dose down to the fraction of a unit. That was portrayed as an "Ahha" moment to them. Maybe it was, maybe it wasn't, but I like the statement "Speed trumps accuracy" and hope it is used more often and sticks. I'm no doctor and there are probably some folks who don't agree with that statement, but I think it's catchy and straight to the point.
- Interest expense has been reduced from 20 mil to 4 mill on an annual basis. Assume it will now be paid for a longer time period, but at this point in time, that move makes sense.
- Towards the end of the presentation (Slide 24) collaborative revenue...MC says "I continue to get inbound calls for the platform to put other peoples drugs on our platform".
- One question during Q&A - Regarding Technosphere - "What's lead to the inbound interest in partnering given that TS has been around for awhile?" MNKD is going to start attending conferences specifically for inhaled platforms. MC referred to one in Europe where TS had been brought up as one to watch which generated three calls. MC also referred to the increased financial stability of the company as a reason for increased interest. It was interesting that whoever brought up TS at the Europe conference had no connection to MNKD and MC didn't know who they were.
One person's perspective... Wow, I missed a lot. I shouldn’t multitask so much. One additional thing is that he emphasized the $2B tax write offs going forward.
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Post by compound26 on Oct 3, 2019 13:09:04 GMT -5
Some new tidbits and/or insights for me were... - MC's reference to the TS platform as the companies "secret sauce", it's the foundation and will be very important (maybe more important than Afrezza?) in the company's future. It seemed to me in the past that the company had been performing this very delicate balancing act of "where does our money go?". My takeaway is that more focused investing into the TS platform compound development now is needed for future support of Afrezza growth. I've wondered where the priority was in the past, but this provided some clarity of me. Not saying it's right or wrong, some folks have strong opinions on that, but that was just some clarity from my perspective.
- Brazil shipment is at or through customs.
- MC referred to the pediatric study more in this presentation that any other from memory. He linked it to changing the standard of care and put a 20-year time from on it. I don't think he actually meant the ADA SOC, but diabetic behavior in general once the pioneer pediatric users of Afrezza continue use in the future as adults. With P3 peds trial to start in 2020, through FDA approval and trial participants reaching adulthood...about 20 years. Can't say that number excited me much, but ultimately getting the peds approval would be huge...still a couple years out though.
- No decision has been made regarding the undisclosed UTHR molecule...despite rumors to the contrary. The molecule is scheduled to start rodent toxicity studies in Q4 or Q1-2020.
- When talking about the pipeline, MC referred to a 2-5 year time frame for receiving milestones payments from UTHR and RLS. Work continues for RLS for an FDA approved product (probably some non FDA as well?). This is the first time I can remember an actual number put on RLS milestones. It's not exactly nailed down by any means, but I think the "2" refers to UTHR and the "5" likely refers to RLS. I hope the 5 is on the conservative side.
- The Pfizer safety data for Exhubra was brought up and referred to as safety data for "inhaled insulin". We already knew it was out there but I think it was the first time presented at an investor conference. (Why did Pfizer do that?...seems odd).
- While at the conference MC met with a group of physicians and asked who was stuck on Afrezza dosing limitations with 4, 8, 12. Apparently many were and MC said "Speed trumps accuracy". Afrezza's speed of action is more important than getting the RAA injected dose down to the fraction of a unit. That was portrayed as an "Ahha" moment to them. Maybe it was, maybe it wasn't, but I like the statement "Speed trumps accuracy" and hope it is used more often and sticks. I'm no doctor and there are probably some folks who don't agree with that statement, but I think it's catchy and straight to the point.
- Interest expense has been reduced from 20 mil to 4 mill on an annual basis. Assume it will now be paid for a longer time period, but at this point in time, that move makes sense.
- Towards the end of the presentation (Slide 24) collaborative revenue...MC says "I continue to get inbound calls for the platform to put other peoples drugs on our platform".
- One question during Q&A - Regarding Technosphere - "What's lead to the inbound interest in partnering given that TS has been around for awhile?" MNKD is going to start attending conferences specifically for inhaled platforms. MC referred to one in Europe where TS had been brought up as one to watch which generated three calls. MC also referred to the increased financial stability of the company as a reason for increased interest. It was interesting that whoever brought up TS at the Europe conference had no connection to MNKD and MC didn't know who they were.
One person's perspective... Good summary.....I can't go in depth right now but one slide stuck out for me. Mike purposely told CF about the 4 Analysts covering MNKD and their Price Targets. He also said that when the money starts flowing in they will have to raise their targets. This is definitely the first time he has done this. Almost saying to CF....you better jump on board now before the train leaves the station. He was very confident if not cocky in mentioning when the money starts rolling in. Regarding the 4 Analysts covering MNKD and their Price Targets, MC specifically noted that in these analysts' reports, most of them did not include international sales of Afrezza or royalties of Treprostinil. Therefore, MC says the price target in these reports will be moved up once these sales/milestones kicks in.
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Post by mytakeonit on Oct 3, 2019 14:06:55 GMT -5
I guess Mike C didn't want to sound too excited and didn't mention the 5th analyst that puts MNKD pps at $100 - $200 in 2 to 5 years.
But, that's mytakeonit
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Post by brotherm1 on Oct 3, 2019 14:21:49 GMT -5
He recently said we have enough cash to break even, and now 2-5 years for TS income (and that’s a maybe), and Afrezza sales not growing. This guy has been BS’s us for years and now it’s more BS. It’s well past time for this joker to hit the road.
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