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Post by sportsrancho on Jul 3, 2024 11:19:59 GMT -5
Humm…
We have the data, the more we have the more clinics we can open, the more clinics we open, the more data we have. #VdexAndFriends😁
We are hiring new practitioners to keep up with demand in each clinic, and there should be three or four more clinics open by the end of the year. 2025 is tracking to be the year to watch!
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Post by sayhey24 on Jul 3, 2024 11:42:11 GMT -5
Humm… We have the data, the more we have the more clinics we can open, the more clinics we open, the more data we have. #VdexAndFriends😁 We are hiring new practitioners to keep up with demand in each clinic, and there should be three or four more clinics open by the end of the year. 2025 is tracking to be the year to watch! Congratulations on your efforts! I am pretty sure you are right about 2025. As soon as we get the news on the kids things could start getting a little crazy. I know a few years ago people were calling me crazy but now I am fully expecting $20+pps in 2025 and more if we get great news on Inhale-2 and Mike kicks off the afrezza/glp1 study. |
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Post by daisyz on Jul 3, 2024 12:26:45 GMT -5
I stepped away from posting here and commenting for the last few months. My commentary was not being appreciated and the audience here continues to decline with only a handful of the original contributors still offering commentary. But there are still those willing to grasp and twist anything that mentions MannKind, by name, into being the Holy Grail and it will bring forth great riches to those owning their stock. The recent data release comparing Afrezza to the “usual care—aka- injected insulin”, is the classic example of those willing to distort the data as being positive for Afrezza. The reality in the data merely confirms what has been known for more than two decades---inhaled insulin does not provide results that exceed what injected insulin provides. It is laughable for those distorting this latest clinical trial data— since, in it, they admit that for some trial patients, their clinical results worsen when they switch to using Afrezza. The following are the key points that MannKind conveyed to shareholders about the data found in this comparative clinical trial. (1) Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpoint (2) More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza® (3) While more people met the glycemic target of A1c (less than 7%) with Afrezza, some subjects worsened when switching from usual care to inhaled insulin, potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime Point #1—it does NOT say that Afrezza is more effective than injected insulin. Repeat after me! ---Afrezza is insulin. Injected insulin is insulin. WHEN insulin is deposited into our circulatory system and into your blood, insulin moves throughout the body and remediates the diabetic condition being experienced by the patient. Once the insulin enters blood system---whether being initially dosed as Afrezza or injectable the remedial agent is simply insulin. And guess what---insurance companies are not keen on paying for a drug that merely carries a Mercedes logo vs a Ford Pinto insulin product. Point #2- What MannKind is spinning is that about 50% of the trial patients clearly stated they had no desire to continue using Afrezza and will stick with their injectable. As for the other 50%, they merely expressed an interest in using. What a spin story coming from MannKind when we have more than a decade of data that clearly shows that about 75% of those who tried Afrezza refuse to refill their prescriptions. Now who wants to make a wager that those 50% expressing an interest, should they opt for Afrezza, then not be one of the 75% historically that opt not to refill their prescription? Point #3 – This admission that clinical trial data shows that switching from injectable insulin to Afrezza worsens a patient’s condition, it was so significant that MannKind was compelled to admit this reality. It appears that MannKind have opened the door to Pandora’s Box. Would be interesting to see if the FDA will add another Black Box warning to the Afrezza prescribing label. • Afrezza’s sales have plateaued, and revenues are merely growing based on price increases MannKind constantly raise. • Afrezza will never achieve enough revenue/profit to justify even the current price of the shares. • Clofazimine will never generate meaningful revenues---merely ask Novartis. If Novartis can’t market clofazimine with their massive marketing team, why would MannKind think they can market it without a sales team and marketing department? How has the numerous times of hiring and firing of the Afrezza sales team worked for MannKind? Who remembers the flying hamburger TV ads? Who remembers the actor hired to be their TV spokesperson? Who spent the money on the MannKind logo being placed on a vehicle going 200 mph on an oval track with a crowd all liquored up? • Just for the record—over recent days and after seeing the latest clinical trial data—I have shorted a couple thousand shares of MannKind’s stock with an APS price of $5.42. It should be obvious that the latest clinical data is being valued as being worthless. I can hardly wait for the next clinical trial to give the stockholder false hope that since Afrezza is merely insulin, just like injected insulin, their CEO has come up with a way to convert it into wine. Maybe you missed my earlier comment and/or you just don't understand.... More subjects utilizing inhaled insulin achieved glycemic targets: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group 30% vs 17% is a 76% improvement over usual care group. (13÷17) 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7% 21% vs 0% over the usual care group! 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group. 24% vs 13% is an 86% improvement over the usual care group (11÷13). Conclusion - Inhaled insulin to treat Type 1 diabetes is superior to usual care treatments. |
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Post by cjm18 on Jul 3, 2024 12:32:57 GMT -5
I stepped away from posting here and commenting for the last few months. My commentary was not being appreciated and the audience here continues to decline with only a handful of the original contributors still offering commentary. But there are still those willing to grasp and twist anything that mentions MannKind, by name, into being the Holy Grail and it will bring forth great riches to those owning their stock. The recent data release comparing Afrezza to the “usual care—aka- injected insulin”, is the classic example of those willing to distort the data as being positive for Afrezza. The reality in the data merely confirms what has been known for more than two decades---inhaled insulin does not provide results that exceed what injected insulin provides. It is laughable for those distorting this latest clinical trial data— since, in it, they admit that for some trial patients, their clinical results worsen when they switch to using Afrezza. The following are the key points that MannKind conveyed to shareholders about the data found in this comparative clinical trial. (1) Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpoint (2) More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza® (3) While more people met the glycemic target of A1c (less than 7%) with Afrezza, some subjects worsened when switching from usual care to inhaled insulin, potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime Point #1—it does NOT say that Afrezza is more effective than injected insulin. Repeat after me! ---Afrezza is insulin. Injected insulin is insulin. WHEN insulin is deposited into our circulatory system and into your blood, insulin moves throughout the body and remediates the diabetic condition being experienced by the patient. Once the insulin enters blood system---whether being initially dosed as Afrezza or injectable the remedial agent is simply insulin. And guess what---insurance companies are not keen on paying for a drug that merely carries a Mercedes logo vs a Ford Pinto insulin product. Point #2- What MannKind is spinning is that about 50% of the trial patients clearly stated they had no desire to continue using Afrezza and will stick with their injectable. As for the other 50%, they merely expressed an interest in using. What a spin story coming from MannKind when we have more than a decade of data that clearly shows that about 75% of those who tried Afrezza refuse to refill their prescriptions. Now who wants to make a wager that those 50% expressing an interest, should they opt for Afrezza, then not be one of the 75% historically that opt not to refill their prescription? Point #3 – This admission that clinical trial data shows that switching from injectable insulin to Afrezza worsens a patient’s condition, it was so significant that MannKind was compelled to admit this reality. It appears that MannKind have opened the door to Pandora’s Box. Would be interesting to see if the FDA will add another Black Box warning to the Afrezza prescribing label. • Afrezza’s sales have plateaued, and revenues are merely growing based on price increases MannKind constantly raise. • Afrezza will never achieve enough revenue/profit to justify even the current price of the shares. • Clofazimine will never generate meaningful revenues---merely ask Novartis. If Novartis can’t market clofazimine with their massive marketing team, why would MannKind think they can market it without a sales team and marketing department? How has the numerous times of hiring and firing of the Afrezza sales team worked for MannKind? Who remembers the flying hamburger TV ads? Who remembers the actor hired to be their TV spokesperson? Who spent the money on the MannKind logo being placed on a vehicle going 200 mph on an oval track with a crowd all liquored up? • Just for the record—over recent days and after seeing the latest clinical trial data—I have shorted a couple thousand shares of MannKind’s stock with an APS price of $5.42. It should be obvious that the latest clinical data is being valued as being worthless. I can hardly wait for the next clinical trial to give the stockholder false hope that since Afrezza is merely insulin, just like injected insulin, their CEO has come up with a way to convert it into wine. Why’ would the fda require another black box warning? Lol. |
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Post by prcgorman2 on Jul 3, 2024 13:04:40 GMT -5
BD - is it going too far if I remark whereas H&W said Mike converted insulin into wine, H&W converted the INHALE-3 results into whine?
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Post by agedhippie on Jul 3, 2024 13:21:51 GMT -5
Maybe you missed my earlier comment and/or you just don't understand.... More subjects utilizing inhaled insulin achieved glycemic targets: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group 30% vs 17% is a 76% improvement over usual care group. (13÷17) 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7% 21% vs 0% over the usual care group! 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group. 24% vs 13% is an 86% improvement over the usual care group (11÷13). Conclusion - Inhaled insulin to treat Type 1 diabetes is superior to usual care treatments. To be clear on this; I think the results are ok, but for me the important thing is who they had on stage talking about Afrezza. That is going to be far more influential than the results we have seen so far. As an example take this metric: 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7%.My initial reaction was wow. Then I thought about it a bit more. You would not expect any change from the usual care group by definition - they are not changing anything from what they have been doing. That 21% of the Afrezza group got below 7% is great, that 0% of the controls did was expected and would have raised question if it had been different. And we can sort of see that in this metric: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care groupIf you take those two together you see that 17% of the usual care group were already below 7% at the start of the trial (0% moved below 7% and 17% ended below 7%) The missing detail is the numbers for patients on MDI and patients on AID in the usual care group that fall into each group. I would be willing to bet that the AID group did well and the MDI group did badly dragging down the usual care group, but without the data we don't know. There is one metric that always gets skipped; 26% of the patients in the inhaled insulin group had a worsening of HbA1c greater than 0.5% compared with 3% with standard care. Again pretty much what I would expect on the control side with 3% being essentially flat, but 26% of Afrezza users got markedly worse? The nett of it is that this was a good day for Afrezza because you had a panel of KOLs saying they liked Afrezza. What all the panel emphasized though was that it's not a magic bullet - it will work well for some but not other making it a matter of matching patients to options. |
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Post by BD on Jul 3, 2024 13:24:19 GMT -5
BD - is it going too far if I remark whereas H&W said Mike converted insulin into wine, H&W converted the INHALE-3 results into whine? I’d have given you an lol if my iPhone offered me the option. |
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Post by sayhey24 on Jul 3, 2024 14:00:41 GMT -5
Maybe you missed my earlier comment and/or you just don't understand.... More subjects utilizing inhaled insulin achieved glycemic targets: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group 30% vs 17% is a 76% improvement over usual care group. (13÷17) 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7% 21% vs 0% over the usual care group! 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group. 24% vs 13% is an 86% improvement over the usual care group (11÷13). Conclusion - Inhaled insulin to treat Type 1 diabetes is superior to usual care treatments. To be clear on this; I think the results are ok, but for me the important thing is who they had on stage talking about Afrezza. That is going to be far more influential than the results we have seen so far. As an example take this metric: 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7%.My initial reaction was wow. Then I thought about it a bit more. You would not expect any change from the usual care group by definition - they are not changing anything from what they have been doing. That 21% of the Afrezza group got below 7% is great, that 0% of the controls did was expected and would have raised question if it had been different. And we can sort of see that in this metric: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care groupIf you take those two together you see that 17% of the usual care group were already below 7% at the start of the trial (0% moved below 7% and 17% ended below 7%) The missing detail is the numbers for patients on MDI and patients on AID in the usual care group that fall into each group. I would be willing to bet that the AID group did well and the MDI group did badly dragging down the usual care group, but without the data we don't know. There is one metric that always gets skipped; 26% of the patients in the inhaled insulin group had a worsening of HbA1c greater than 0.5% compared with 3% with standard care. Again pretty much what I would expect on the control side with 3% being essentially flat, but 26% of Afrezza users got markedly worse? The nett of it is that this was a good day for Afrezza because you had a panel of KOLs saying they liked Afrezza. What all the panel emphasized though was that it's not a magic bullet - it will work well for some but not other making it a matter of matching patients to options. Wow - that was one heck of a spin but fully expected. 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7% Simply put, afrezza is better at reaching goal. The usual care group are never getting there. Its that simple. 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group Simply put afrezza is better when properly dosed. I expected the AID would outperform during fasting hours but they dosed afrezza before bed and smoked the AID. We knew they would smoke the AID for prandial use. That was a good move to win and did not cause additional hypos which was huge. 26% of the patients in the inhaled insulin group had a worsening of HbA1c greater than 0.5% compared with 3% with standard care Yep, and were tracked on the CGMs and did not properly dose. However 74% did not which is a huge number. Could you imagine if afrezza got 50% of the T1 market? That would be huge too. I think the even bigger take away is no one really wants to wear a pump. Now they don't and they can get even better numbers. What kid playing tennis or soccer wants to wear a pump? Could you imagine a wrestler or football player wearing a pump. Once the kids get approved I would expect nearly 50% will be afrezza users. This raises the question, what now for Medtronic? They could have owned afrezza 20 years ago but passed at the time. Now its pretty clear afrezza has obsoleted the pump and no AID algorithm will make the AID faster that afrezza so further AID research is pretty much DOA. |
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Post by ktim on Jul 6, 2024 17:47:53 GMT -5
I did some sunny day back o’ the napkin calculations for which I’d like some criticism. I went back to 1Q 2024 results to review work in progress to try to better remember the current revenue and future revenue opportunity and the sequence and timing of events leading to the revenue by 2030. The short story is MNKD should enjoy annual revenue in 2024 between $250 and $300 million and estimates here on the board have been believably a little north of $275M, and the long-term outlook by 2030 is maybe 10x the 2024 revenue, give or take. I’m guessing somewhere between $2.5B and $3B. If shares outstanding don’t change much, that could mean more than $10 EPS and with a P/E of 17 (which I think is conservative) the share price could be $170/share in 2030. Calculating revenue CAGR using CAGR = (Ending Value / Starting Value)^(1 / Number of Years) – 1 and multiplying the result by 100 yields an unbelievable 46.8% CAGR. While the result of the calculation is unbelievable, the development path is believable. What are the assumptions leading to this conclusion? We’ve already assumed ~$275M in annual revenue for 2024, so the assumptions are based on answering the question, what will the current and future revenue streams contribute that result in a 10x increase in revenue in 6 years? Afrezza net revenue in 1Q was >16% YoY versus 1Q23. We know price is perceived as a barrier to uptake but we can assume INHALE-3 results were influential and that INHALE-1 results should be no less so and usefully improve the marketability of Afrezza. I will assume a conservative 10% growth YoY between 2024 and 2030 based on improvements in marketability such as INHALE-1 and INHALE-3 results and improvements in price, insurance coverage, and intl sales. Starting with ~$72M in net revenue for 2024, 10% more each year yields about $140M in 2030. This is very conservative and ignores significant revenue from Cipla which may not be a good assumption. Tyvaso DPI is harder to estimate. Manufacturing revenue was supposed to plateau but didn’t because of funding capacity improvements. UTHR is building their own capacity and the revenue to MNKD from operating UTHRs plant is difficult to estimate. If we assume the original $2B in sales for Tyvaso DPI based on prescriptions for PAH, the royalties would plateau around $200M, but because of the work to expand the market with additional indications, the sales and related plateau may be $400M to $600M or more. I’ll use $500M by 2030. MannKind estimated revenue of $217M for clofazimine in 2030. Slide 11 of the 1Q results slides seems to indicate that sales of Ofev for IPF will top $5B in 2024 and begin declining after that but without an explanation for why. I assume the reason is nintedanib DPI will do to Ofev what Tyvaso DPI has done to Tyvaso, and that MannKind is assuming they may own most of the Ofev market for IPF by 2030 with an estimated market of $7.5B in 2030. So there it is. Revenue from Afrezza, Tyvaso DPI royalties and manufacturing, and clofazimine could account for $850M+ by 2030. That means MannKind’s nintedanib DPI needs to account for ~$2.5B+ in revenue to yield a $10 EPS in 2030. Given the existing and assumed increased market size for nintedanib and the uptake of nintedanib DPI versus Ofev, it doesn’t seem like an unreasonable set of assumptions. Just an observation, but your 2030 numbers are way ahead of the roughly $1.2B revenue shown on that long term revenue graph presented by management latter half of last year. |
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Post by ktim on Jul 6, 2024 17:57:04 GMT -5
As long as we are discussing the rules, what is the back story on this one: 8. Nudity and pornography. 8.1. Posters are not allowed to sit at the computer while naked. There I thought it was only prohibited if submitting short sell orders. |
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Post by ktim on Jul 6, 2024 17:59:32 GMT -5
Humm… We have the data, the more we have the more clinics we can open, the more clinics we open, the more data we have. #VdexAndFriends😁 We are hiring new practitioners to keep up with demand in each clinic, and there should be three or four more clinics open by the end of the year. 2025 is tracking to be the year to watch! Congratulations on your efforts! I am pretty sure you are right about 2025. As soon as we get the news on the kids things could start getting a little crazy. I know a few years ago people were calling me crazy but now I am fully expecting $20+pps in 2025 and more if we get great news on Inhale-2 and Mike kicks off the afrezza/glp1 study. What is we get trial results merely inline with expectations, and Mike doesn't kick of Afrezza/GLP1 study? |
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Post by prcgorman2 on Jul 6, 2024 19:52:34 GMT -5
I did some sunny day back o’ the napkin calculations for which I’d like some criticism. ... So there it is. Revenue from Afrezza, Tyvaso DPI royalties and manufacturing, and clofazimine could account for $850M+ by 2030. That means MannKind’s nintedanib DPI needs to account for ~$2.5B+ in revenue to yield a $10 EPS in 2030. Given the existing and assumed increased market size for nintedanib and the uptake of nintedanib DPI versus Ofev, it doesn’t seem like an unreasonable set of assumptions. Just an observation, but your 2030 numbers are way ahead of the roughly $1.2B revenue shown on that long term revenue graph presented by management latter half of last year. Didn't look back but I'm sure you're right. I also think my estimate of nintedanib was based on not fully understanding the Ofev, et al bars in the charts on page 11 of the last earning call. The slide doesn't offer an explanation of why the chart on the left indicates $7.5B revenue potential in 2030 while the chart on the right shows declining Ofev revenues. I did suggest it must mean MannKind's nintedanib DPI will be the reason for the decline in Ofev, but after some thought, that's just too weak. Insufficient information on which to guess for sure what's anticipated. Frankly, I'd be very happy with $1.2B in revenue (and $850M to $900M in profit). |
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Post by sayhey24 on Jul 7, 2024 7:48:03 GMT -5
Congratulations on your efforts! I am pretty sure you are right about 2025. As soon as we get the news on the kids things could start getting a little crazy. I know a few years ago people were calling me crazy but now I am fully expecting $20+pps in 2025 and more if we get great news on Inhale-2 and Mike kicks off the afrezza/glp1 study. What is we get trial results merely inline with expectations, and Mike doesn't kick of Afrezza/GLP1 study? The expectation is the kids get approved. The expectation is Mike can take the Inhale-3 results and get SoC changes to justify insurance coverage. With the kids approval and insurance coverage afrezza will take 50% of the pediatric T1 market. That makes MNKD a $20pps stock. We already know from Inhale-3 that when dosed properly afrezza beats MDI and the AID. Rumors are the kids are doing great but there is pressure on the FDA to delay approval. Mike has already mentioned the 6 months. Inhale-2 and the afrezza/glp1 study is about the T2 market. The kids are about the T1 market. Mike has said several times afrezza was showing a 1.5 - 2.0% A1c reduction in Inhale-2. This on par with GLP1s in the T2 market with the difference being GLP1s provide the benefit of weight loss but afrezza provides the benefit of post prandial glucose control. Most GLP1 users also see A1c rising after a year or two. Mike needs to develop a strategy where afrezza is not competing against GLP1s in the T2 market but rather complements them and enhances the PWDs glucose control. Once he figures this out and afrezza gets T2 insurance coverage MNKD is at least $100pps. Now, if Mike wanted to pop the pps sooner than later he would put a GLP1 analog on TS and see how it works out. Mike referred to the weight loss market as a "craze". like a passing fad. Ozempic for weight loss is not a fad and a TS inhaled GLP1 could take a significant piece of that market. |
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Post by agedhippie on Jul 7, 2024 8:43:09 GMT -5
What is we get trial results merely inline with expectations, and Mike doesn't kick of Afrezza/GLP1 study? The expectation is the kids get approved. The expectation is Mike can take the Inhale-3 results and get SoC changes to justify insurance coverage. ... INHALE-3 still only managed non-inferior. Insurance decision are justified as outcome based and the outcome has not changed. What change are you expecting from the SoC that will force insurance cover? |
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Post by prcgorman2 on Jul 7, 2024 8:44:38 GMT -5
Remind me again. What is the benefit of inhalable GLP1? I know people on Ozempic and Wegovy. They’re not in the least deterred by a once-weekly subcutaneous injection. And for sure they care very much that it is helping them lose weight. I don’t know but do assume that the far majority of prescriptions for these drugs has almost everything to do with losing weight and almost nothing to do with diabetes.
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