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Post by golfeveryday on Jun 2, 2019 7:55:32 GMT -5
the thing is if they know how to use it for corrections then they know how to use it. Then why do you think they aren’t using it for their meals, are they just using it before they go to bed? Or when they have an unexpected high? Or is it the cost? could be many things including just being hesitant to try something new fully. I’m sure Lilly and Novo are out there repositioning Afrezza as too fast for meal coverage maybe and just use it for corrections. A correction is simply correcting a high blood glucose which is no different than correction a post prandial blood glucose spike due to a meal. I personally wouldn’t carry around an insulin pen for my meals and an Afrezza inhaler for in between corrections. Takes the convenience right out of it.
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Post by agedhippie on Jun 2, 2019 8:22:03 GMT -5
the thing is if they know how to use it for corrections then they know how to use it. Then why do you think they aren’t using it for their meals, are they just using it before they go to bed? Or when they have an unexpected high? Or is it the cost? I can imagine people using just a single mealtime dose, going high after the Afrezza wears off, and assuming that it doesn't work for them for meals. They could continue to use it as a rescue insulin though since they can see and understand that drop. That it doesn't work for meals is an easy assumption for them because lots of diabetics have an ingrained expectation that what works for one person doesn't necessarily work for another. The alternative is that they simply are not prepared to take a follow up mealtime dose.
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Post by matt on Jun 2, 2019 8:24:38 GMT -5
I think it would be awesome if they got Deerfield paid off and got a nondilutive loan from a friendlier lender. Indeed it would be awesome to have a "friendly" lender, but like the unicorn I am not so sure such a beast exists. I used to do a lot of merger and acquisition work for a major industry player and that required me to read a lot of debt instruments because the buyer always winds up paying off the existing debt and the details matter in figuring out how much that will cost. The covenants imposed by Deerfield were pretty much standard in the industry, and far less onerous than those imposed by other lenders. Certainly those covenants became burdensome, but only because MNKD was not executing well on its business plan. Had the Sanofi relationship worked out better or if MNKD has been able to grow sales as originally planned then those covenants would not even be mentioned. Reasonable covenants only become "unfriendly" when the company does not perform to plan and the lender starts enforcing them to ensure that the debt is paid. If lenders wanted to take on the risk of owning MNKD they wouldn't be lenders, they would be equity investors. The other challenge with finding a new source of "friendly" money is that Deerfield is the most senior claim to the assets, but both the Mann Group loan and the convertible debt have junior secured claims. Any new lender would be third in line in the event of worst case scenario, and the only way for new money to be first in line is for the other lenders to agree to be subordinated. That may be possible with the Mann Group (although the company is now dealing with trustees and not the Mann family directly), but it is highly unlikely that the convertible debt will agree to subordination. Absent a secured first priority lien on all assets of the company, any lender will want something else to mitigate the lending risk and that is almost certainly going to be dilutive. The only truly friendly non-dilutive money is license deals like with UTHR, but those deals are not easy to find and the timing is unpredictable. There are not a lot of easy answers to fixing the capital structure.
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Post by ktim on Jun 2, 2019 8:29:35 GMT -5
I think you are right about the retention rate. It's bad..why wouldn't it be? Docs aren't interested in it.. patients don't know anything about it except the ones who are fortunate enough to stumble across it or see one of our few ads.. and then if they are lucky enough to meet up with another Afrezza user who can mentor them.... And get insurance to pay for it after all that.. it's a miracle we have as many scripts as we do.. We do need a partner.. we always have.. I don't think that has ever been in question.. But we also need to be careful about who that partner is. And most of all we need money.. How does one market a drug like this without it?
>> We do need a partner..[..].we need money..
Endless repetition does not make things true! This is both wrong! If the current sales trend continues, it takes about 2-3years before the Afrezza sale numbers for US adults lead to an income and it will cost about 100-150mil$ to get there. Will already have a big part of that money and a smart management could get loan for the missing amount without dilution. In the other forum a poster guessed that a partner would cost 50% of a 2Bil$ consortium, I guess that was per year, why would we need to throw money out of the window like that! Even a dilution or giving away more molecules to UHTR is a better choice than a partner!
It seems like at present rate of stagnant NRx, it's more like 6 years to profitability. The debt has been reduced, but with the deteriorated market cap, it's still not a balance sheet that is going to make debt financing easy. As for partners I would assume there probably aren't any that would give the sort of assurances that MNKD would hopefully look for to prevent a company from sitting on the asset. If we do seek one, there need to be a binding commitments by the partner, such as starting trials to show superiority.
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Post by morfu on Jun 2, 2019 11:33:00 GMT -5
>> We do need a partner..[..].we need money..
Endless repetition does not make things true! This is both wrong! If the current sales trend continues, it takes about 2-3years before the Afrezza sale numbers for US adults lead to an income and it will cost about 100-150mil$ to get there. Will already have a big part of that money and a smart management could get loan for the missing amount without dilution. In the other forum a poster guessed that a partner would cost 50% of a 2Bil$ consortium, I guess that was per year, why would we need to throw money out of the window like that! Even a dilution or giving away more molecules to UHTR is a better choice than a partner!
It seems like at present rate of stagnant NRx, it's more like 6 years to profitability. The debt has been reduced, but with the deteriorated market cap, it's still not a balance sheet that is going to make debt financing easy. As for partners I would assume there probably aren't any that would give the sort of assurances that MNKD would hopefully look for to prevent a company from sitting on the asset. If we do seek one, there need to be a binding commitments by the partner, such as starting trials to show superiority. >> it's more like 6 years to profitability.
Well, if you look at the member section "Afrezza Script Counts and Other Metrics" there is a rather new entry labeled "Afrezza Charts II" In there you can see, that the Afrezza Gross revenue for 2017 was 15mil$ followed by 36mil$ in 2018.
This year it will be higher beside a seemingly slow start, likely around 50mil$ (its 20mil$ in the first 5month) + of course any other profit Mannkind will generate. That leads other poster to the conclusion that end 2020 might be a possible date for green numbers, I am more careful and add a year. What is the basis for your 6 years? Gut feeling? We seem to have a few of them around here...
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Post by ktim on Jun 2, 2019 11:47:25 GMT -5
It seems like at present rate of stagnant NRx, it's more like 6 years to profitability. The debt has been reduced, but with the deteriorated market cap, it's still not a balance sheet that is going to make debt financing easy. As for partners I would assume there probably aren't any that would give the sort of assurances that MNKD would hopefully look for to prevent a company from sitting on the asset. If we do seek one, there need to be a binding commitments by the partner, such as starting trials to show superiority. >> it's more like 6 years to profitability.
Well, if you look at the member section "Afrezza Script Counts and Other Metrics" there is a rather new entry labeled "Afrezza Charts II" In there you can see, that the Afrezza Gross revenue for 2017 was 15mil$ followed by 36mil$ in 2018.
This year it will be higher beside a seemingly slow start, likely around 50mil$ (its 20mil$ in the first 5month) + of course any other profit Mannkind will generate. That leads other poster to the conclusion that end 2020 might be a possible date for green numbers, I am more careful and add a year. What is the basis for your 6 years? Gut feeling? We seem to have a few of them around here... A simple linear projection of the revenue growth. Granted, picking starting and ending points shifts that one way or the other. Using your numbers it seems gross revenue (and I believe you mean retail gross, not actual gross revenue to Mannkind, correct?) is increasing roughly $15M this year. All told that gets cut in half for MNKD net revenue... so $25M net this year growing at $7.5M per year give or take? Seems getting to profitability in 3 years would require NRx to break out of stagnation and thus TRx starting to rise faster than linearly.
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Post by stevil on Jun 2, 2019 11:55:21 GMT -5
My guess for why Afrezza isn’t used exclusively is one of at least 3 things.
1. The longer tail leads to a greater reduction in A1c without follow up dosing
2. It’s more burdensome to constantly need to dose more than once per food intake
3.Repetitive multiple doses leads to a much higher cost than combining the two.
I’m not in the camp that says MC should be fired, all 3 should be able to be fixed by him and his crew. Studies showing proper dosing leads to better A1c reduction, fewer repetitive dosages, and overall reduced cost (although Without the benefit of time it’s harder to prove this one...) at this point it makes sense to commit heavy resources to fewer interested docs because conversion rates thus far have been abysmal. They need to identify doctors that are open minded and flood them with attention and resources to convert.
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Post by peppy on Jun 2, 2019 12:07:50 GMT -5
My guess for why Afrezza isn’t used exclusively is one of at least 3 things. 1. The longer tail leads to a greater reduction in A1c without follow up dosing 2. It’s more burdensome to constantly need to dose more than once per food intake 3.Repetitive multiple doses leads to a much higher cost than combining the two. I’m not in the camp that says MC should be fired, all 3 should be able to be fixed by him and his crew. Studies showing proper dosing leads to better A1c reduction, fewer repetitive dosages, and overall reduced cost (although Without the benefit of time it’s harder to prove this one...) at this point it makes sense to commit heavy resources to fewer interested docs because conversion rates thus far have been abysmal. They need to identify doctors that are open minded and flood them with attention and resources to convert. 1. The longer tail leads to a greater reduction in A1c without follow up dosing
my words, and the hypos help reduce the HbA1c... nicely hidden. yeah this is better. so then they fear this and allow themselves to run high. Steal, I have known a fair share of physicians in my life and....... ? added: because it is difficult to stop. what Afrezza is up against is the for profit medical insurance dare I say it, Mafia. Look what we, our the medical system expect type ones to deal with. How to use insulin. They have to count their carbs determine there dose, take the dose which takes two hours by every continuous glucose monitor I see, and they are told to predose. what type of working job allows these people to pre dose and know what they are going to eat. Then they have to finger stick to see where they blood glucose is.... these people have to take care of them selves all the damn time. MattB from mattdownunder, he said in one of his video's the way he handled it is to eat at home. with Afrezza he got to go out and eat. I'll stop. and fix my typos later. my rant doesn't change our insurance coverage situation. what ever mealtime insulin these people are put on there is a lot of care required, bozo
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Post by mannmade on Jun 2, 2019 12:18:10 GMT -5
Then why do you think they aren’t using it for their meals, are they just using it before they go to bed? Or when they have an unexpected high? Or is it the cost? I can imagine people using just a single mealtime dose, going high after the Afrezza wears off, and assuming that it doesn't work for them for meals. They could continue to use it as a rescue insulin though since they can see and understand that drop. That it doesn't work for meals is an easy assumption for them because lots of diabetics have an ingrained expectation that what works for one person doesn't necessarily work for another. The alternative is that they simply are not prepared to take a follow up mealtime dose. Why would a pwd take one dose and assume it does not work for them when they often bolus or take susequent dose's on RAA's? I have never undestood this.
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Post by peppy on Jun 2, 2019 13:28:37 GMT -5
I think it would be awesome if they got Deerfield paid off and got a nondilutive loan from a friendlier lender. Indeed it would be awesome to have a "friendly" lender, but like the unicorn I am not so sure such a beast exists. I used to do a lot of merger and acquisition work for a major industry player and that required me to read a lot of debt instruments because the buyer always winds up paying off the existing debt and the details matter in figuring out how much that will cost. The covenants imposed by Deerfield were pretty much standard in the industry, and far less onerous than those imposed by other lenders. Certainly those covenants became burdensome, but only because MNKD was not executing well on its business plan. Had the Sanofi relationship worked out better or if MNKD has been able to grow sales as originally planned then those covenants would not even be mentioned. Reasonable covenants only become "unfriendly" when the company does not perform to plan and the lender starts enforcing them to ensure that the debt is paid. If lenders wanted to take on the risk of owning MNKD they wouldn't be lenders, they would be equity investors. The other challenge with finding a new source of "friendly" money is that Deerfield is the most senior claim to the assets, but both the Mann Group loan and the convertible debt have junior secured claims. Any new lender would be third in line in the event of worst case scenario, and the only way for new money to be first in line is for the other lenders to agree to be subordinated. That may be possible with the Mann Group (although the company is now dealing with trustees and not the Mann family directly), but it is highly unlikely that the convertible debt will agree to subordination. Absent a secured first priority lien on all assets of the company, any lender will want something else to mitigate the lending risk and that is almost certainly going to be dilutive. The only truly friendly non-dilutive money is license deals like with UTHR, but those deals are not easy to find and the timing is unpredictable. There are not a lot of easy answers to fixing the capital structure. Didn't Deerfield have to pay a fine for the inside information they go on Afrezza insurance coverage/label? Deerfield shorted MNKD all the way down as well. is that in the covenants? Is it reported anywhere?
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Post by sayhey24 on Jun 2, 2019 17:56:05 GMT -5
I can imagine people using just a single mealtime dose, going high after the Afrezza wears off, and assuming that it doesn't work for them for meals. They could continue to use it as a rescue insulin though since they can see and understand that drop. That it doesn't work for meals is an easy assumption for them because lots of diabetics have an ingrained expectation that what works for one person doesn't necessarily work for another. The alternative is that they simply are not prepared to take a follow up mealtime dose. Why would a pwd take one dose and assume it does not work for them when they often bolus or take susequent dose's on RAA's? I have never undestood this. Its a cost thing. They are rationing their use of Afrezza. If it were free most would be exclusive Afrezza users and most are not aware of insulinsavings.com
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Post by agedhippie on Jun 2, 2019 19:18:52 GMT -5
I can imagine people using just a single mealtime dose, going high after the Afrezza wears off, and assuming that it doesn't work for them for meals. They could continue to use it as a rescue insulin though since they can see and understand that drop. That it doesn't work for meals is an easy assumption for them because lots of diabetics have an ingrained expectation that what works for one person doesn't necessarily work for another. The alternative is that they simply are not prepared to take a follow up mealtime dose. Why would a pwd take one dose and assume it does not work for them when they often bolus or take subsequent dose's on RAA's? I have never understood this. It's the difference between what people should do and what they actually do. With RAA you are told to test after two hours and correct if necessary - I don't know anyone who actually does that! You hardly ever need that second dose so it just gets forgotten. Most meters even include (or used to) an alarm function that you are meant to set to two hours to remind you to retest. What tends to happen is you get on with your life and don't bother to check up to the point where you are starting to feel something is wrong and then you test and correct if necessary. This doesn't happen as often as you might think because the tail cleans up a lot of messes. Looking at STAT results it seems like that second dose is required with Afrezza because there is a short tail so when people behave the same as they do with RAA and skip the second dose they get non-optimal results. Why is the length of the insulin tail important? Because carbs also have a tail and this is why endos don't see RAA's tail as a bad thing. You can only absorb carbs at a certain rate (there is a standardized curve for this), but it is made more complex if what you are eating deviates from the ideal meal that curve is based on. Fat and complex carbs will extend carb absorption beyond that curve. Some foods like burgers or pizza outlast even the RAA tail and pumps use automatic follow up boluses to extend the tail (you tell the pump to split the bolus, some now and some later). Some artificial pancreas systems like Loop can handle the variable carb tail duration by using a dynamic carb absorption rate - they spot when the carbs are not having the impact expected and flatten the curve accordingly which produces a lower carb absorption rate and a longer tail. If you are really bored there is a good explanation how it's done here - github.com/LoopKit/Loop/pull/507 (the technical side) and here seemycgm.com/2017/07/25/loop-dynamic-carb-absorption/ (how it affects their daughter)
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Post by agedhippie on Jun 2, 2019 19:28:18 GMT -5
Didn't Deerfield have to pay a fine for the inside information they go on Afrezza insurance coverage/label? Deerfield shorted MNKD all the way down as well. is that in the covenants? Is it reported anywhere? I don't think they ever got fined. Companies often short to cover the capital of loans they make because it locks the share price. Now when the share price drops they don't care because they have "sold" the value of their loan at the original price. It's why BoA was loaned those shares to short the stock.
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Post by ilovekauai on Jun 2, 2019 19:34:55 GMT -5
Deerfield is not our friend nor have they ever been. Deerfield is a wolf in sheep's clothing and poison to the future success of MNKD. Pay then off and show them the door for good. In fact, kick Deerfield out of the door with a size 10 1/2 boot for good measure. Find another way for funding that won't short us into BK, like Deerfield has been trying to do for years now. Thank you.
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Post by peppy on Jun 2, 2019 19:42:52 GMT -5
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