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Post by peppy on Jun 4, 2018 12:56:07 GMT -5
A drug that is illegal to sell in the US is also illegal to export, period full stop. There are no exceptions to this rule even if the drug would meet regulatory requirements at its intended destination. If MNKD had segregated production lines they could use insulin raw material from two different suppliers (so long as both were approved), but if the company wanted to use insulin from two different suppliers on the same production line they would either need to shut down the line for cleaning between batches to avoid cross-contamination, or else MNKD would have to prove that the two insulins were identical in every way. Proving identity for a large protein produced by different methods by different companies is probably an impossible task. As for India and China, stop thinking of those as markets. They are not markets, they are countries on a map that happen to be occupied by a lot of people, most of whom are still poor by world standards. There is a market for the upper class, which may account for 10% of the population, that is covered by private medical insurance and which has considerable disposable income. The opportunity is to sell to to the 10% because the other 90% struggle to buy food and can't afford much medicine at all. The other thing to keep in mind is that most countries in the world are used to paying FAR LESS than US prices for drugs. Here are a few examples of current approved government prices for rapid acting human insulins: Germany, 100U/ML, 30 ML vials (3,000 units) Euro 86.96 = US$101.67 United Kingdom, 100U/ML, 10ML vials (1,000 units) Pounds 14.08 = US$18.75 New Zealand, 100U/ML, 10ML vials (1,000 units) NZ$ 30.03 = US$21.11 India (State of Tamil Nadu), 40U/ML, 10 ML vials (400 units) INR 51.20 = US$0.76 Oman, 100U/ML, 5X3ML Cartridges (1500 units), OMR 19.84 = $23.19 Canada (Ontario), 100U/ML, 10ML vials (1,000) CA$29.64 = US$22.91You can work out the cost per unit for yourself to make the comparisons apples to apples, but consider that the 4U / 90 cartridge pack of Afrezza (360 total units) retails for about $300 in the US. Government health authorities used to paying far less for RAI are simply not going to pay for Afrezza. If you can't make money selling to the German government, then it is nearly hopeless trying to sell to any other government in the world other than the US. There is a reason US health insurance costs are so high. Which is why I say that shareholders need to quit looking at raw population numbers and maps of the world and start looking at income distributions and the number of actually wealthy consumers in the international markets. That will make the potential readily visible since it is only the few that do not rely on government healthcare that constitute a viable opportunity. Here is a good list of links to official price lists at various government ministries around the world maintained by the World Health Organization, the numbers may surprise you: www.who.int/medicines/areas/access/sources_prices/national_medicine_price_sources.pdf. quote: There is a market for the upper class, which may account for 10% of the population, that is covered by private medical insurance and which has considerable disposable income. The opportunity is to sell to to the 10% Agreed. The upper upper class in these markets are the targets. .001% probably enough. We know it is not common for these populations to have health insurance in these markets. Perhaps what people have no concept of is how rich the rich are in these countries. lasbrisasproperties.com
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Post by mango on Jun 4, 2018 12:58:06 GMT -5
A drug that is illegal to sell in the US is also illegal to export, period full stop. There are no exceptions to this rule even if the drug would meet regulatory requirements at its intended destination. If MNKD had segregated production lines they could use insulin raw material from two different suppliers (so long as both were approved), but if the company wanted to use insulin from two different suppliers on the same production line they would either need to shut down the line for cleaning between batches to avoid cross-contamination, or else MNKD would have to prove that the two insulins were identical in every way. Proving identity for a large protein produced by different methods by different companies is probably an impossible task. As for India and China, stop thinking of those as markets. They are not markets, they are countries on a map that happen to be occupied by a lot of people, most of whom are still poor by world standards. There is a market for the upper class, which may account for 10% of the population, that is covered by private medical insurance and which has considerable disposable income. The opportunity is to sell to to the 10% because the other 90% struggle to buy food and can't afford much medicine at all. The other thing to keep in mind is that most countries in the world are used to paying FAR LESS than US prices for drugs. Here are a few examples of current approved government prices for rapid acting human insulins:Germany, 100U/ML, 30 ML vials (3,000 units) Euro 86.96 = US$101.67 United Kingdom, 100U/ML, 10ML vials (1,000 units) Pounds 14.08 = US$18.75 New Zealand, 100U/ML, 10ML vials (1,000 units) NZ$ 30.03 = US$21.11 India (State of Tamil Nadu), 40U/ML, 10 ML vials (400 units) INR 51.20 = US$0.76 Oman, 100U/ML, 5X3ML Cartridges (1500 units), OMR 19.84 = $23.19 Canada (Ontario), 100U/ML, 10ML vials (1,000) CA$29.64 = US$22.91You can work out the cost per unit for yourself to make the comparisons apples to apples, but consider that the 4U / 90 cartridge pack of Afrezza (360 total units) retails for about $300 in the US. Government health authorities used to paying far less for RAI are simply not going to pay for Afrezza. If you can't make money selling to the German government, then it is nearly hopeless trying to sell to any other government in the world other than the US. There is a reason US health insurance costs are so high. Which is why I say that shareholders need to quit looking at raw population numbers and maps of the world and start looking at income distributions and the number of actually wealthy consumers in the international markets. That will make the potential readily visible since it is only the few that do not rely on government healthcare that constitute a viable opportunity. Here is a good list of links to official price lists at various government ministries around the world maintained by the World Health Organization, the numbers may surprise you: www.who.int/medicines/areas/access/sources_prices/national_medicine_price_sources.pdf. That is because Eli Lilly and Company, Novo Nordisk, and Sanofi each participate in corrupt, collaborative-collusion
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Post by kc on Jun 4, 2018 13:50:22 GMT -5
That is because Eli Lilly and Company, Novo Nordisk, and Sanofi each participate in corrupt, collaborative-collusion
MannKind Should make a Paradigm shift and go Cheap and on a direct subscription. Put the big Phama boys to shame.
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Post by gcozz on Jun 4, 2018 13:53:19 GMT -5
A drug that is illegal to sell in the US is also illegal to export, period full stop. There are no exceptions to this rule even if the drug would meet regulatory requirements at its intended destination. If MNKD had segregated production lines they could use insulin raw material from two different suppliers (so long as both were approved), but if the company wanted to use insulin from two different suppliers on the same production line they would either need to shut down the line for cleaning between batches to avoid cross-contamination, or else MNKD would have to prove that the two insulins were identical in every way. Proving identity for a large protein produced by different methods by different companies is probably an impossible task. As for India and China, stop thinking of those as markets. They are not markets, they are countries on a map that happen to be occupied by a lot of people, most of whom are still poor by world standards. There is a market for the upper class, which may account for 10% of the population, that is covered by private medical insurance and which has considerable disposable income. The opportunity is to sell to to the 10% because the other 90% struggle to buy food and can't afford much medicine at all. The other thing to keep in mind is that most countries in the world are used to paying FAR LESS than US prices for drugs. Here are a few examples of current approved government prices for rapid acting human insulins: Germany, 100U/ML, 30 ML vials (3,000 units) Euro 86.96 = US$101.67 United Kingdom, 100U/ML, 10ML vials (1,000 units) Pounds 14.08 = US$18.75 New Zealand, 100U/ML, 10ML vials (1,000 units) NZ$ 30.03 = US$21.11 India (State of Tamil Nadu), 40U/ML, 10 ML vials (400 units) INR 51.20 = US$0.76 Oman, 100U/ML, 5X3ML Cartridges (1500 units), OMR 19.84 = $23.19 Canada (Ontario), 100U/ML, 10ML vials (1,000) CA$29.64 = US$22.91You can work out the cost per unit for yourself to make the comparisons apples to apples, but consider that the 4U / 90 cartridge pack of Afrezza (360 total units) retails for about $300 in the US. Government health authorities used to paying far less for RAI are simply not going to pay for Afrezza. If you can't make money selling to the German government, then it is nearly hopeless trying to sell to any other government in the world other than the US. There is a reason US health insurance costs are so high. Which is why I say that shareholders need to quit looking at raw population numbers and maps of the world and start looking at income distributions and the number of actually wealthy consumers in the international markets. That will make the potential readily visible since it is only the few that do not rely on government healthcare that constitute a viable opportunity. Here is a good list of links to official price lists at various government ministries around the world maintained by the World Health Organization, the numbers may surprise you: www.who.int/medicines/areas/access/sources_prices/national_medicine_price_sources.pdf. Do we know that Mannkind hasn't begun the process of getting the Pfizer insulin certified for use? As I see it, they may be contractually prevented from selling Afrezza made from that material in the U.S. and other markets, but that would not prevent them from producing Afrezza from newly certified Pfizer insulin for otherwise unencumbered markets. As for the cross-contamination issue, I doubt we're using all 3 installed lines. On the face of it, I would think that producing Afrezza from this feedstock would lower the cost of goods sold in those markets, thereby increasing profit potential. Otherwise, why keep the stuff around.
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Post by traderdennis on Jun 4, 2018 13:57:17 GMT -5
A drug that is illegal to sell in the US is also illegal to export, period full stop. There are no exceptions to this rule even if the drug would meet regulatory requirements at its intended destination. If MNKD had segregated production lines they could use insulin raw material from two different suppliers (so long as both were approved), but if the company wanted to use insulin from two different suppliers on the same production line they would either need to shut down the line for cleaning between batches to avoid cross-contamination, or else MNKD would have to prove that the two insulins were identical in every way. Proving identity for a large protein produced by different methods by different companies is probably an impossible task. As for India and China, stop thinking of those as markets. They are not markets, they are countries on a map that happen to be occupied by a lot of people, most of whom are still poor by world standards. There is a market for the upper class, which may account for 10% of the population, that is covered by private medical insurance and which has considerable disposable income. The opportunity is to sell to to the 10% because the other 90% struggle to buy food and can't afford much medicine at all. The other thing to keep in mind is that most countries in the world are used to paying FAR LESS than US prices for drugs. Here are a few examples of current approved government prices for rapid acting human insulins: Germany, 100U/ML, 30 ML vials (3,000 units) Euro 86.96 = US$101.67 United Kingdom, 100U/ML, 10ML vials (1,000 units) Pounds 14.08 = US$18.75 New Zealand, 100U/ML, 10ML vials (1,000 units) NZ$ 30.03 = US$21.11 India (State of Tamil Nadu), 40U/ML, 10 ML vials (400 units) INR 51.20 = US$0.76 Oman, 100U/ML, 5X3ML Cartridges (1500 units), OMR 19.84 = $23.19 Canada (Ontario), 100U/ML, 10ML vials (1,000) CA$29.64 = US$22.91You can work out the cost per unit for yourself to make the comparisons apples to apples, but consider that the 4U / 90 cartridge pack of Afrezza (360 total units) retails for about $300 in the US. Government health authorities used to paying far less for RAI are simply not going to pay for Afrezza. If you can't make money selling to the German government, then it is nearly hopeless trying to sell to any other government in the world other than the US. There is a reason US health insurance costs are so high. Which is why I say that shareholders need to quit looking at raw population numbers and maps of the world and start looking at income distributions and the number of actually wealthy consumers in the international markets. That will make the potential readily visible since it is only the few that do not rely on government healthcare that constitute a viable opportunity. Here is a good list of links to official price lists at various government ministries around the world maintained by the World Health Organization, the numbers may surprise you: www.who.int/medicines/areas/access/sources_prices/national_medicine_price_sources.pdf. Do we know that Mannkind hasn't begun the process of getting the Pfizer insulin certified for use? As I see it, they may be contractually prevented from selling Afrezza made from that material in the U.S. and other markets, but that would not prevent them from producing Afrezza from newly certified Pfizer insulin for otherwise unencumbered markets. As for the cross-contamination issue, I doubt we're using all 3 installed lines. On the face of it, I would think that producing Afrezza from this feedstock would lower the cost of goods sold in those markets, thereby increasing profit potential. Otherwise, why keep the stuff around. It is a non issue to begin using the Pfizer insulin at time due to the large commitment Mnkd made us use insulin from amphastar. Currently the minimum contractual purchase of amphastar insulin far exceeds the the current demand for Afrezza. Might as well just use the fresh stuff.
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Post by mnholdem on Jun 4, 2018 14:21:31 GMT -5
If memory serves (I'm on shaky ground at my age) the Pfizer insulin is worth over $1 billion. Al Mann got it for pennies on the dollar.
Also, PB members have recently pointed out that the Amphastar purchase agreement contract has some exclusions for a few global regions/countries.
Taking these two factors into account, I think that MannKind will get the stockpiled insulin qualified in due time.
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Post by mango on Jun 4, 2018 16:24:28 GMT -5
That is because Eli Lilly and Company, Novo Nordisk, and Sanofi each participate in corrupt, collaborative-collusion
MannKind Should make a Paradigm shift and go Cheap and on a direct subscription. Put the big Phama boys to shame.
Heard that!
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Post by agedhippie on Jun 4, 2018 20:56:22 GMT -5
If memory serves (I'm on shaky ground at my age) the Pfizer insulin is worth over $1 billion. Al Mann got it for pennies on the dollar. Also, PB members have recently pointed out that the Amphastar purchase agreement contract has some exclusions for a few global regions/countries. Taking these two factors into account, I think that MannKind will get the stockpiled insulin qualified in due time. It was a curious deal Mannkind bought $3 million of insulin, and was paid $3 million to store and maintain the remainder of the stock for Pfizer so effectively Mannkind was paid in insulin. That purchased insulin was written off to R&D nearly 10 years ago so there probably isn't any left. Mannkind has a standing option to purchase insulin from the stockpile at an agreed price from Pfizer. This is all documented in the 10Q from 2009. Even if Mannkind got the insulin qualified they would still have to buy it from Pfizer. In theory Pfizer has first call on the insulin, but I do not think they have any use for it so preemption is unlikely and it can be viewed as available.
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Post by agedhippie on Jun 4, 2018 20:59:51 GMT -5
...Otherwise, why keep the stuff around. Because Mannkind signed a contract and took $3 million from Pfizer to keep it around for Pfizer.
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Post by mango on Jun 4, 2018 21:08:20 GMT -5
If memory serves (I'm on shaky ground at my age) the Pfizer insulin is worth over $1 billion. Al Mann got it for pennies on the dollar. Also, PB members have recently pointed out that the Amphastar purchase agreement contract has some exclusions for a few global regions/countries. Taking these two factors into account, I think that MannKind will get the stockpiled insulin qualified in due time. It was a curious deal Mannkind bought $3 million of insulin, and was paid $3 million to store and maintain the remainder of the stock for Pfizer so effectively Mannkind was paid in insulin. That purchased insulin was written off to R&D nearly 10 years ago so there probably isn't any left. Mannkind has a standing option to purchase insulin from the stockpile at an agreed price from Pfizer. This is all documented in the 10Q from 2009. Even if Mannkind got the insulin qualified they would still have to buy it from Pfizer. In theory Pfizer has first call on the insulin, but I do not think they have any use for it so preemption is unlikely and it can be viewed as available. This is incorrect as MannKind literally just sold $1.7 million of surplus bulk insulin to a third party in Q1 2017. (The bulk insulin was Pfizer insulin)
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Post by Deleted on Jun 4, 2018 22:33:11 GMT -5
It was a curious deal Mannkind bought $3 million of insulin, and was paid $3 million to store and maintain the remainder of the stock for Pfizer so effectively Mannkind was paid in insulin. That purchased insulin was written off to R&D nearly 10 years ago so there probably isn't any left. Mannkind has a standing option to purchase insulin from the stockpile at an agreed price from Pfizer. This is all documented in the 10Q from 2009. Even if Mannkind got the insulin qualified they would still have to buy it from Pfizer. In theory Pfizer has first call on the insulin, but I do not think they have any use for it so preemption is unlikely and it can be viewed as available. This is incorrect as MannKind literally just sold $1.7 million of surplus bulk insulin to a third party in Q1 2017. (The bulk insulin was Pfizer insulin) Thats not correct. If you go back and look at the 2014 ASM AL, HAKAN & MATT talked about the insulin in Storage. It's in storage and tested routinely to make sure composition is stable. IMO they will use this insulin for BIC countries where they pay nothing for drugs. The insulin has been written off (ie EXPENSED) already and have ZERO VALUE. Matt said once it comes back into COGS it will have a nominal value. (I think - it was hard to hear what he said)
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Post by agedhippie on Jun 4, 2018 22:46:50 GMT -5
It was a curious deal Mannkind bought $3 million of insulin, and was paid $3 million to store and maintain the remainder of the stock for Pfizer so effectively Mannkind was paid in insulin. That purchased insulin was written off to R&D nearly 10 years ago so there probably isn't any left. Mannkind has a standing option to purchase insulin from the stockpile at an agreed price from Pfizer. This is all documented in the 10Q from 2009. Even if Mannkind got the insulin qualified they would still have to buy it from Pfizer. In theory Pfizer has first call on the insulin, but I do not think they have any use for it so preemption is unlikely and it can be viewed as available. This is incorrect as MannKind literally just sold $1.7 million of surplus bulk insulin to a third party in Q1 2017. (The bulk insulin was Pfizer insulin) Since they sold surplus insulin in Q1 2017 and now have done so in Q1 2018 I think it is far more likely that this is insulin that was contracted for but did not use.
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Post by Deleted on Jun 4, 2018 23:08:44 GMT -5
This is incorrect as MannKind literally just sold $1.7 million of surplus bulk insulin to a third party in Q1 2017. (The bulk insulin was Pfizer insulin) Since they sold surplus insulin in Q1 2017 and now have done so in Q1 2018 I think it is far more likely that this is insulin that was contracted for but did not use. Now we can always talk about AL's value of that stored insulin. I believe Al said it was worth $10 Billion Dollars worth. Al also said during the 2014 ASM there's enough to give to 10M patients.
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Post by agedhippie on Jun 5, 2018 7:43:05 GMT -5
Since they sold surplus insulin in Q1 2017 and now have done so in Q1 2018 I think it is far more likely that this is insulin that was contracted for but did not use. Now we can always talk about AL's value of that stored insulin. I believe Al said it was worth $10 Billion Dollars worth. Al also said during the 2014 ASM there's enough to give to 10M patients. The insulin is owned by Pfizer. Mannkind was paid in $3 million of that insulin to store it for Pfizer and got an option to buy from the stockpile at an agreed price (the price was redacted in the contract). This was what was left after the agreement for Mannkind to buy Pfizer's German insulin manufacturer fell apart when Sanofi bought it instead. The contract is filed with the SEC, and there are press releases from Mannkind if you want to check.
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