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Post by sportsrancho on Jul 20, 2018 10:54:51 GMT -5
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Post by sportsrancho on Jul 20, 2018 11:48:28 GMT -5
I am very pleased to report that Mike Castagna, MannKind’s CEO, has decided the time is right launch a fairly aggressive marketing campaign. The company is now running Afrezza TV ads on a wide variety of networks and programming-styles (news, game shows, etc.) in a rather impressive number of regions around the country. The variety of demographics it is aimed at ought to go a long ways towards addressing the “awareness” piece of the puzzle that has been cited by many as a reason scripts haven’t been ramping faster.
In addition, now that additional studies have been released, MannKind’s sales reps can finally start talking about the benefits of Afrezza that those of us in the real world have known about anecdotally for several years now.
Now that all the pieces are in place to market the real benefits of Afrezza, we will soon get an accurate gauge of Afrezza’s commercial potential. If we do not see a significant improvement in sales over the next six to twelve months, I will have no choice but to start re-evaluating my outlook.
My current plan is to make one last sizable purchase this month then sit tight through August and September, and then make a decision about what to do next based on how the trend in scripts is looking.
No, we’re not out of the woods yet. But after all the work Castagna and his team have done over the past eighteen months, Afrezza is proving to be all it was cracked up to be, and, at least so far, Castagna & Co. have done nothing but demonstrate that they’ve got what it will take to see things through and make MannKind very successful.
MNKD is a strong buy under $5 and a buy under $10.
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Post by sayhey24 on Jul 20, 2018 15:15:30 GMT -5
Nate's window of 6 to 12 months is a reasonable time frame for the impact from the initial standard of care updates.
By Jan 2019 MNKD needs Dr. Kendall's initial updates to the standard of care in place principally for the T1's. This will allows for an evaluation within Nate's 12 month window. However, its going to take 18 months for a significant update to the T2 section.
I hope Dr. Kendall can prove me wrong and get things done sooner. However, when he delivers on "the easiest job he has ever had" afrezza will then realize its potential and should hits Aged's Trucility number of $2B as sales are ramping up.
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Post by agedhippie on Jul 20, 2018 16:42:26 GMT -5
Nate's window of 6 to 12 months is a reasonable time frame for the impact from the initial standard of care updates. By Jan 2019 MNKD needs Dr. Kendall's initial updates to the standard of care in place principally for the T1's. This will allows for an evaluation within Nate's 12 month window. However, its going to take 18 months for a significant update to the T2 section. I hope Dr. Kendall can prove me wrong and get things done sooner. However, when he delivers on "the easiest job he has ever had" afrezza will then realize its potential and should hits Aged's Trucility number of $2B as sales are ramping up. What do you see the initial SoC change is for January 2019? |
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Post by golfeveryday on Jul 20, 2018 19:12:31 GMT -5
Nate's window of 6 to 12 months is a reasonable time frame for the impact from the initial standard of care updates. By Jan 2019 MNKD needs Dr. Kendall's initial updates to the standard of care in place principally for the T1's. This will allows for an evaluation within Nate's 12 month window. However, its going to take 18 months for a significant update to the T2 section. I hope Dr. Kendall can prove me wrong and get things done sooner. However, when he delivers on "the easiest job he has ever had" afrezza will then realize its potential and should hits Aged's Trucility number of $2B as sales are ramping up. MNKD needs SOC for a stratospheric share price move, but it certainly doesn’t need it to reset to a ‘reasonable’ value in anticipation. Where we sit is ridiculous. Also, they can’t do this alone. Fact. |
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Post by sayhey24 on Jul 20, 2018 20:14:04 GMT -5
Golf - Where we sit today is not ridiculous if you believe afrezza is following the same path as Exubera and will fail in the market. Based on current and past sales and money spent to date by the company its easy to make the case. Few, currently understand what afrezza really is and that is reflected in the current pps. Heck, most people think its another rapid acting analog but provides worse A1c. In fact, that's what the standard of care currently says. Additionally, MNKD over the last 6 years hasn't done a lot to help itself. MNKD needed to put afrezza in a position to immediately impact the standard of care once approved but they did not. They turned over the task to SNY who did nothing to move the ball. Until Dr. Kendall showed up nothing was done. Until Mike found the lost studies and had Dr. Kendall review them and Dr. Kendall joined the team there was never a focus and plan to get the standard of care updated. Aged asked what needs to be done. The initial target is updating the T1 section. The current recommendations consist of four bullets. The second bullet currently says "Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk." It needs to be updated to say Most T1s should use inhaled insulin to reduce hypoglycemia and allow improved A1c over rapid-acting insulin analog use. Those not able to use inhaled insulin should use rapid-acting insulin analogs to reduce hypoglycemia risk. With the STAT results applied to Affinity-1 Dr Kendall is now making the argument that afrezza can reduce A1c from 8.0 to 6.8 with no additional hypoglycemia. If he is succeeding in moving the ADA politicians the market will start getting the message in September but Dr. Kendall needs to deliver. He also needs to get some mention of inhaled insulin in the T2 section soon but to get it as Step2 may take 2 years. In the mean time nothing is stopping Mike from closing some deals and getting the word out. A couple of real deals will help the pps short term but just doing Trulicity sales of $2B with 50% margin assuming 200m outstanding shares gives you eps of 5. Using a 30x multiplier puts the pps at $150. We are not getting there until afrezza is in the standard. I saw somewhere yesterday Duke and UNC are now looking to do afrezza studies. I can only guess the ADA suggested that direction after ADA2018. Things are moving in the right direction but selling afrezza is all about the standard of care. Does anyone think metformin would get prescribed like candy unless it was step 1 in the standard? Its junk. What did Ralph DeFronzo say “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forum |
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Post by agedhippie on Jul 20, 2018 21:53:32 GMT -5
Aged asked what needs to be done. The initial target is updating the T1 section. The current recommendations consist of four bullets. The second bullet currently says "Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk." It needs to be updated to say Most T1s should use inhaled insulin to reduce hypoglycemia and allow improved A1c over rapid-acting insulin analog use. Those not able to use inhaled insulin should use rapid-acting insulin analogs to reduce hypoglycemia risk. That is not going to get that done by the end of 2018, and probably not even by the end of 2019. There is not enough A or B class evidence to support that move today so it will take at least one large trial to achieve the change. STAT points the way for how a trial could be configured to do that. What I can see the change being is adding Afrezza alongside RAA like this:- "Most individuals with type 1 diabetes should use rapid-acting insulin analogs or inhaled encapsulated insulin to reduce hypoglycemia risk."That is supported by the non-inferiority finding in the 171 trial which makes Afrezza an equivalent. It will be fun to see how they phrase the inhaled insulin part without explicitly naming Afrezza, but being specific enough about what they are talking about. |
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Post by agedhippie on Jul 20, 2018 22:08:00 GMT -5
Nate's window of 6 to 12 months is a reasonable time frame for the impact from the initial standard of care updates. By Jan 2019 MNKD needs Dr. Kendall's initial updates to the standard of care in place principally for the T1's. This will allows for an evaluation within Nate's 12 month window. However, its going to take 18 months for a significant update to the T2 section. I hope Dr. Kendall can prove me wrong and get things done sooner. However, when he delivers on "the easiest job he has ever had" afrezza will then realize its potential and should hits Aged's Trucility number of $2B as sales are ramping up. MNKD needs SOC for a stratospheric share price move, but it certainly doesn’t need it to reset to a ‘reasonable’ value in anticipation. Where we sit is ridiculous. Also, they can’t do this alone. Fact. The market thinks Mannkind is heading for a guidance miss and given that is not about to believe anything else management says until there is hard evidence. In other words do not expect a reset in anticipation of an SOC change, only expect a reset on an actual material SOC change. I think part of the price drop is pricing in the pending funding round discount and dilution - nobody wants to buy at the old price if that price is about to drop. Once the funding round is done and the cost can be measured the price will likely stabilize, but right now everyone is pricing in a worst case or just staying clear. |
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Post by morgieporgie on Jul 20, 2018 22:23:49 GMT -5
MNKD needs SOC for a stratospheric share price move, but it certainly doesn’t need it to reset to a ‘reasonable’ value in anticipation. Where we sit is ridiculous. Also, they can’t do this alone. Fact. The market thinks Mannkind is heading for a guidance miss and given that is not about to believe anything else management says until there is hard evidence. In other words do not expect a reset in anticipation of an SOC change, only expect a reset on an actual material SOC change. I think part of the price drop is pricing in the pending funding round discount and dilution - nobody wants to buy at the old price if that price is about to drop. Once the funding round is done and the cost can be measured the price will likely stabilize, but right now everyone is pricing in a worst case or just staying clear. It will definitely rise on anticipation of being a stand of care. People in the know load up before it's announced. That's how it works. Same for the drops before the funding, just in reverse. |
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Post by sayhey24 on Jul 21, 2018 7:07:27 GMT -5
Aged - I understand your position that Dr. Kendall does not have enough A or B class evidence to support that move today so it will take at least one large trial to achieve the change.
Dr. Kendall based on the lost studies and his current advisory panel thinks he does. I hope he is right and it really is the easiest job he has ever had, as he said. At this point I have no reason not to believe him.
If in fact you are correct, worst case is its just a matter of time. Its no longer a question of is afrezza as good as the early adopters where saying. Given CGM technology and cloud monitoring if the STAT was scaled to 5000 PWDs, IMO you would see the same results. Two things we know for sure is the pancreas works and afrezza is using the exact same insulin with almost the exact same PK.
How he approaches the T2s and what he has in the lost studies we will have to see. I think you will be correct and a large study needs to be done here. If they can replicate the 118 results on a large scale and can show near zero hypo events when properly dosed, its game over for the anti-glycemics. It also starts the discussion of should pre-diabetic treatment change from a long daily walk and diet to a long daily walk, diet and afrezza. Thats the study I would like to see but that one will take years.
I agree with you on that the market thinks Mannkind is heading for a guidance miss and given that is not about to believe anything else management says until there is hard evidence. The problem is why should the market even think MNKD can sell one box a week let alone 500+ and growing? Based on the current growing script count in the the face of the current standard saying "its junk" is pretty shocking.
Is Mike going to close a deal and hit his guidance? I sure hopes so but its not going to be on U.S. script growth. Very few doctors are going to write afrezza scripts based on the current standard.
The thing with MNKD is, its a matter of time. The question is how much more time and how much more dilution? Nate is saying 6 to 12 months. I think by September we should be getting a sense on Dr. Kendall's ability to move the needle in the 6 to 12 month window.
To sum things up we have an FDA approved drug which is performing better than most people expected with no health concerns after 3+ years and current users are call it life changing. We have technology in the CGM Cloud which is telling the game changing story of afrezza in real-time. We also have a standard of care calling it junk. And, we have a CMO with a plan to change the standard and if he doesn't have all the studies he needs over time he will be able to get them.
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Post by golfeveryday on Jul 21, 2018 7:31:52 GMT -5
Golf - Where we sit today is not ridiculous if you believe afrezza is following the same path as Exubera and will fail in the market. Based on current and past sales and money spent to date by the company its easy to make the case. Few, currently understand what afrezza really is and that is reflected in the current pps. Heck, most people think its another rapid acting analog but provides worse A1c. In fact, that's what the standard of care currently says. Additionally, MNKD over the last 6 years hasn't done a lot to help itself. MNKD needed to put afrezza in a position to immediately impact the standard of care once approved but they did not. They turned over the task to SNY who did nothing to move the ball. Until Dr. Kendall showed up nothing was done. Until Mike found the lost studies and had Dr. Kendall review them and Dr. Kendall joined the team there was never a focus and plan to get the standard of care updated. Aged asked what needs to be done. The initial target is updating the T1 section. The current recommendations consist of four bullets. The second bullet currently says "Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk." It needs to be updated to say Most T1s should use inhaled insulin to reduce hypoglycemia and allow improved A1c over rapid-acting insulin analog use. Those not able to use inhaled insulin should use rapid-acting insulin analogs to reduce hypoglycemia risk. With the STAT results applied to Affinity-1 Dr Kendall is now making the argument that afrezza can reduce A1c from 8.0 to 6.8 with no additional hypoglycemia. If he is succeeding in moving the ADA politicians the market will start getting the message in September but Dr. Kendall needs to deliver. He also needs to get some mention of inhaled insulin in the T2 section soon but to get it as Step2 may take 2 years. In the mean time nothing is stopping Mike from closing some deals and getting the word out. A couple of real deals will help the pps short term but just doing Trulicity sales of $2B with 50% margin assuming 200m outstanding shares gives you eps of 5. Using a 30x multiplier puts the pps at $150. We are not getting there until afrezza is in the standard. I saw somewhere yesterday Duke and UNC are now looking to do afrezza studies. I can only guess the ADA suggested that direction after ADA2018. Things are moving in the right direction but selling afrezza is all about the standard of care. Does anyone think metformin would get prescribed like candy unless it was step 1 in the standard? Its junk. What did Ralph DeFronzo say “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forum appreciate your commentary on here. Read it daily. However, I don’t think we are in a $1.50 or $150 scenario. |
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Post by joeypotsandpans on Jul 21, 2018 12:40:36 GMT -5
Golf - Where we sit today is not ridiculous if you believe afrezza is following the same path as Exubera and will fail in the market. Based on current and past sales and money spent to date by the company its easy to make the case. Few, currently understand what afrezza really is and that is reflected in the current pps. Heck, most people think its another rapid acting analog but provides worse A1c. In fact, that's what the standard of care currently says. Additionally, MNKD over the last 6 years hasn't done a lot to help itself. MNKD needed to put afrezza in a position to immediately impact the standard of care once approved but they did not. They turned over the task to SNY who did nothing to move the ball. Until Dr. Kendall showed up nothing was done. Until Mike found the lost studies and had Dr. Kendall review them and Dr. Kendall joined the team there was never a focus and plan to get the standard of care updated. Aged asked what needs to be done. The initial target is updating the T1 section. The current recommendations consist of four bullets. The second bullet currently says "Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk." It needs to be updated to say Most T1s should use inhaled insulin to reduce hypoglycemia and allow improved A1c over rapid-acting insulin analog use. Those not able to use inhaled insulin should use rapid-acting insulin analogs to reduce hypoglycemia risk. With the STAT results applied to Affinity-1 Dr Kendall is now making the argument that afrezza can reduce A1c from 8.0 to 6.8 with no additional hypoglycemia. If he is succeeding in moving the ADA politicians the market will start getting the message in September but Dr. Kendall needs to deliver. He also needs to get some mention of inhaled insulin in the T2 section soon but to get it as Step2 may take 2 years. In the mean time nothing is stopping Mike from closing some deals and getting the word out. A couple of real deals will help the pps short term but just doing Trulicity sales of $2B with 50% margin assuming 200m outstanding shares gives you eps of 5. Using a 30x multiplier puts the pps at $150. We are not getting there until afrezza is in the standard. I saw somewhere yesterday Duke and UNC are now looking to do afrezza studies. I can only guess the ADA suggested that direction after ADA2018. Things are moving in the right direction but selling afrezza is all about the standard of care. Does anyone think metformin would get prescribed like candy unless it was step 1 in the standard? Its junk. What did Ralph DeFronzo say “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forumsayhey24 if true (would love to see what you read if you can find it) then no one better with ties to both institutions then the head/chairman of the MNKD SAB board: uncdiabetes.org/dr-john-buse-md-phd/also goes right in line with your following statements: "so it will take at least one large trial to achieve the change. " "And, we have a CMO with a plan to change the standard and if he doesn't have all the studies he needs over time he will be able to get them." They don't call it the research triangle for nothing, plenty of medical research and education at UNC/DUKE hospitals and medical centers and Kendall has one of the leading peers in the space on board. He didn't ask Buse to chair the SAB without looking at the bigger picture IMO. Kendall has started to remind and embellish past research as well: Lancet publication showing the reduced incidence of hypoglycemia: www.thelancet.com/pdfs/journals/lancet/PIIS0140673610606320.pdfRead more: mnkd.proboards.com/post/153301/quote/10248?page=1#ixzz5LuWJ15iORead more: mnkd.proboards.com/post/153301/quote/10248?page=1#ixzz5LuVPjApC |
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Post by lennymnkd on Jul 21, 2018 13:26:29 GMT -5
Aged - I understand your position that Dr. Kendall does not have enough A or B class evidence to support that move today so it will take at least one large trial to achieve the change. Dr. Kendall based on the lost studies and his current advisory panel thinks he does. I hope he is right and it really is the easiest job he has ever had, as he said. At this point I have no reason not to believe him. If in fact you are correct, worst case is its just a matter of time. Its no longer a question of is afrezza as good as the early adopters where saying. Given CGM technology and cloud monitoring if the STAT was scaled to 5000 PWDs, IMO you would see the same results. Two things we know for sure is the pancreas works and afrezza is using the exact same insulin with almost the exact same PK. How he approaches the T2s and what he has in the lost studies we will have to see. I think you will be correct and a large study needs to be done here. If they can replicate the 118 results on a large scale and can show near zero hypo events when properly dosed, its game over for the anti-glycemics. It also starts the discussion of should pre-diabetic treatment change from a long daily walk and diet to a long daily walk, diet and afrezza. Thats the study I would like to see but that one will take years. I agree with you on that the market thinks Mannkind is heading for a guidance miss and given that is not about to believe anything else management says until there is hard evidence. The problem is why should the market even think MNKD can sell one box a week let alone 500+ and growing? Based on the current growing script count in the the face of the current standard saying "its junk" is pretty shocking. Is Mike going to close a deal and hit his guidance? I sure hopes so but its not going to be on U.S. script growth. Very few doctors are going to write afrezza scripts based on the current standard. The thing with MNKD is, its a matter of time. The question is how much more time and how much more dilution? Nate is saying 6 to 12 months. I think by September we should be getting a sense on Dr. Kendall's ability to move the needle in the 6 to 12 month window. To sum things up we have an FDA approved drug which is performing better than most people expected with no health concerns after 3+ years and current users are call it life changing. We have technology in the CGM Cloud which is telling the game changing story of afrezza in real-time. We also have a standard of care calling it junk. And, we have a CMO with a plan to change the standard and if he doesn't have all the studies he needs over time he will be able to get them. |
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Post by lennymnkd on Jul 21, 2018 13:27:52 GMT -5
Given CGM technology and cloud monitoring if the STAT was scaled to 5000 PWDs, IMO you would see the same results. Two things we know for sure is the pancreas works and afrezza is using the exact same insulin with almost the exact same PK / bingo , my sentiments exactly
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Post by agedhippie on Jul 21, 2018 14:04:25 GMT -5
Given CGM technology and cloud monitoring if the STAT was scaled to 5000 PWDs, IMO you would see the same results. Two things we know for sure is the pancreas works and afrezza is using the exact same insulin with almost the exact same PK / bingo , my sentiments exactly A quick reality check here. Only 15% of Type 1 diabetics have a CGM and they probably aren't all using them. I have no idea what cloud monitoring means, storing data in the cloud? That has been done for years with Diasend but it doesn't buy much since it gets looked at retroactively by your endo when you visit. I think if you scaled STAT you would get the same result. The interesting thing would be to see what the numbers looked like after 52 weeks because I am willing to bet compliance will drop off sharply given the compliance numbers for the 4 week trial. If compliance can be maintained though then that would be huge. |
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