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Post by cgiscgis on Jan 16, 2016 8:54:16 GMT -5
How long will it take for Afrezza to become available worldwide?
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Post by mnkdmorelong on Jan 16, 2016 9:01:46 GMT -5
How long will it take for Afrezza to become available worldwide? In some countries it depends how well your bribes are placed. I am not totally kidding. This is why a local partner is very important. It's mostly a registration issue. MNKD must change the packaging to local language. I can see six months. But, but, but.......not a real solution to the cash problem because ASPs will be real low.
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Post by bthomas55ep on Jan 16, 2016 13:41:03 GMT -5
How long will it take for Afrezza to become available worldwide? In some countries it depends how well your bribes are placed. I am not totally kidding. This is why a local partner is very important. It's mostly a registration issue. MNKD must change the packaging to local language. I can see six months. But, but, but.......not a real solution to the cash problem because ASPs will be real low. I would disagree that ROW for Afrezza is not a solution to the cash problem. It is THE solution. The model will be to sell the rights to distribute Afrezza in a specific region for an upfront payment and possibility as small royalty % in return once that BP is profitable. The three major regions are Asia, the Eurozone, and the Middle East. I could envision the possibility of selling those distribution rights for several hundred million dollars up to a Billion to three different BP's. Of course MNKD would maintain rights to all U.S. Distribution for Afrezza and worldwide distribution rights on all other T/S applications for now. This extends the runway for several years as the company works to validate T/S through Afrezza. IMO.
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Post by mnkdmorelong on Jan 16, 2016 13:50:18 GMT -5
In some countries it depends how well your bribes are placed. I am not totally kidding. This is why a local partner is very important. It's mostly a registration issue. MNKD must change the packaging to local language. I can see six months. But, but, but.......not a real solution to the cash problem because ASPs will be real low. I would disagree that ROW for Afrezza is not a solution to the cash problem. It is THE solution. The model will be to sell the rights to distribute Afrezza in a specific region for an upfront payment and possibility as small royalty % in return once that BP is profitable. The three major regions are Asia, the Eurozone, and the Middle East. I could envision the possibility of selling those distribution rights for several hundred million dollars up to a Billion to three different BP's. Of course MNKD would maintain rights to all U.S. Distribution for Afrezza and worldwide distribution rights on all other T/S applications for now. This extends the runway for several years as the company works to validate T/S through Afrezza. IMO. I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market.
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Post by peppy on Jan 16, 2016 13:53:48 GMT -5
I would disagree that ROW for Afrezza is not a solution to the cash problem. It is THE solution. The model will be to sell the rights to distribute Afrezza in a specific region for an upfront payment and possibility as small royalty % in return once that BP is profitable. The three major regions are Asia, the Eurozone, and the Middle East. I could envision the possibility of selling those distribution rights for several hundred million dollars up to a Billion to three different BP's. Of course MNKD would maintain rights to all U.S. Distribution for Afrezza and worldwide distribution rights on all other T/S applications for now. This extends the runway for several years as the company works to validate T/S through Afrezza. IMO. I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. if my memory services me correctly, that $7.41 a day was all 4 u doses. Just saying, more like 10 to11 buckaroos a day is where sanofi priced afrezza.
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Post by mnkdmorelong on Jan 16, 2016 14:01:33 GMT -5
I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. if my memory services me correctly, that $7.41 a day was all 4 u doses. Just saying, more like 10 to11 buckaroos a day is where sanofi priced afrezza.
At $10-11/day, it makes the economics worse.
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Post by peppy on Jan 16, 2016 14:03:04 GMT -5
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Post by bthomas55ep on Jan 16, 2016 14:18:15 GMT -5
I would disagree that ROW for Afrezza is not a solution to the cash problem. It is THE solution. The model will be to sell the rights to distribute Afrezza in a specific region for an upfront payment and possibility as small royalty % in return once that BP is profitable. The three major regions are Asia, the Eurozone, and the Middle East. I could envision the possibility of selling those distribution rights for several hundred million dollars up to a Billion to three different BP's. Of course MNKD would maintain rights to all U.S. Distribution for Afrezza and worldwide distribution rights on all other T/S applications for now. This extends the runway for several years as the company works to validate T/S through Afrezza. IMO. I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. I must not be making myself clear on what I am suggesting Mannkind do: As an example, for a one time payment of $350 Million, Mannkind sells the entire Eurozone Afrezza franchise to a BP who would then own 100% of the rights to market and distribute to the Eurozone forever. They could keep the name Afrezza or name it something else. The BP would use Danbury mfg as their supplier which would part of their cogs. BP only pays for what they sell and when profitable, share a small sales royalty back to Mannkind. If Cogs are 50%, how long does it take BP to recoup payment. After $700 Million they are break even. Is it realistic to think BP could sell $250 Million a year for 10 or more years? Do something similar for Asia and the Middle East. That's where the $1 Billion up front comes to Mannkind, then the product acquirer owns the brand in their region forever.
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Post by Deleted on Jan 16, 2016 14:21:27 GMT -5
I would disagree that ROW for Afrezza is not a solution to the cash problem. It is THE solution. The model will be to sell the rights to distribute Afrezza in a specific region for an upfront payment and possibility as small royalty % in return once that BP is profitable. The three major regions are Asia, the Eurozone, and the Middle East. I could envision the possibility of selling those distribution rights for several hundred million dollars up to a Billion to three different BP's. Of course MNKD would maintain rights to all U.S. Distribution for Afrezza and worldwide distribution rights on all other T/S applications for now. This extends the runway for several years as the company works to validate T/S through Afrezza. IMO. I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. so now its $1.2 bln per yr to break even.. up from $500 mil ?
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Post by matt on Jan 16, 2016 15:53:07 GMT -5
How long will it take for Afrezza to become available worldwide? Nearly all drugs are approved from the CTD (Common Technical Document). This is a computer format approved by all the major countries that incorporates most of the data on a drug application. If the company planned it properly, all the data for Afrezza exists in a CTD. Them the requirement is to add certain sections to the CTD based on extra local requirements without having to resubmit the whole thing.
The biggest market you can attack with a single additional approval is the EU, which includes approvals in the four countries that are non-EU but members of EFTA (Norway, Iceland, Lichtenstein, Switzerland). The EMEA, the European equivalent of the FDA is allowed 210 days to issue an opinion PLUS "clock stops". If the application contain all necessary information there are no clock stops but if the committee wants to see more data, the clock stops until the data is provided. If the company has the data, the clock will normally be stopped for just a few weeks. If the company needs to collect the data (like with another trial) it can be stopped for years. Finally, there are 60 days for the EU Parliament to formally approve the drug via enabling legislation (officially the EMEA doesn't approve, the just make a recommendation to the parliament for approval). So, the minimum time in Europe is 270 days with no clock stops, same as in the US.
Japan uses a process similar to the US and EU, but with slightly different requirements. If the file preparation was properly planned, the company will have all the data. If not, it invokes a clock stop. Some of the Japanese requirements are not that different (like stability tests at certain dates) but they are different dates than FDA requires. If MNKD regulatory had their act together when the process started, they collected the data and just need to submit it.
Most other countries will unofficially accept a drug approved in US and EU upon application without doing a separate review. They may ask a few questions and approve label copy in the local language, but in the grand scheme of things those extra requirements are trivial. With a good CTD, a drug should be approvable within a year almost anywhere in the world. If the CTD is poorly done or the company regulatory function doesn't have the experience a drug can linger for years.
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Post by mnkdmorelong on Jan 16, 2016 16:23:01 GMT -5
I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. so now its $1.2 bln per yr to break even.. up from $500 mil ? Yes, several on this board came up with reliable quantitative data and I rolled it into the economic model based on the SNY deal. The $500 mln did not take into account that the SNY deal was a de facto 25% royalty deal. MNKD needs to cut Afrezza prices by at least 50% to be competitive in the US. To be competitive in emerging markets, the ASP goes down even further. Declining contribution margin (net dollars received by MNKD) per unit sale only drives the break even point higher.
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Post by mnkdmorelong on Jan 16, 2016 16:29:12 GMT -5
I am very sorry but the numbers do not add up. You know that the US pays the most for drugs. There is a pecking order and the less developed countries pay the least. Off the top of my head, Afrezza was priced by SNY at $7.41/day per user. The competitive price for other RAA is $3.14/day/user. I did a computation based on known data that at the lower price, MNKD would have to sell $1.2 bln/yr in Afrezza to break even. If MNKD sells at lower ASPs in emerging countries, the breakeven point becomes even more preposterous. There is not 1 bln of upfront money to be received from emerging markets. It's a cheaper market. I must not be making myself clear on what I am suggesting Mannkind do: As an example, for a one time payment of $350 Million, Mannkind sells the entire Eurozone Afrezza franchise to a BP who would then own 100% of the rights to market and distribute to the Eurozone forever. They could keep the name Afrezza or name it something else. The BP would use Danbury mfg as their supplier which would part of their cogs. BP only pays for what they sell and when profitable, share a small sales royalty back to Mannkind. If Cogs are 50%, how long does it take BP to recoup payment. After $700 Million they are break even. Is it realistic to think BP could sell $250 Million a year for 10 or more years? Do something similar for Asia and the Middle East. That's where the $1 Billion up front comes to Mannkind, then the product acquirer owns the brand in their region forever. You do not realize that it no longer 2014. Afrezza is no longer the fresh product that everyone wants. The marketing of Afrezza failed in the US under SNY's control. The economics for the next partner has changed. MNKD is no longer selling in Neiman Marcus. ROW markets are Wal-Mart types. MNKD will not get the huge up front payments you are expecting. You are only guessing on COGS. Why would you create a model based on this?
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Post by LosingMyBullishness on Jan 16, 2016 17:02:11 GMT -5
mnkdlongmore, Regarding the Eurozone and Japan as less developed countries displays an ignorance that's better avoided. Blocking members is a feature as this board that I really appreciate.
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Post by mnkdmorelong on Jan 16, 2016 17:08:36 GMT -5
mnkdlongmore, Regarding the Eurozone and Japan as less developed countries displays an ignorance that's better avoided. Blocking members is a feature as this board that I really appreciate. And you can't read. Japan was not mentioned. The rest of the world, including the EU pays less for drugs.
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Post by mindovermatter on Jan 16, 2016 17:09:11 GMT -5
I must not be making myself clear on what I am suggesting Mannkind do: As an example, for a one time payment of $350 Million, Mannkind sells the entire Eurozone Afrezza franchise to a BP who would then own 100% of the rights to market and distribute to the Eurozone forever. They could keep the name Afrezza or name it something else. The BP would use Danbury mfg as their supplier which would part of their cogs. BP only pays for what they sell and when profitable, share a small sales royalty back to Mannkind. If Cogs are 50%, how long does it take BP to recoup payment. After $700 Million they are break even. Is it realistic to think BP could sell $250 Million a year for 10 or more years? Do something similar for Asia and the Middle East. That's where the $1 Billion up front comes to Mannkind, then the product acquirer owns the brand in their region forever. You do not realize that it no longer 2014. Afrezza is no longer the fresh product that everyone wants. The marketing of Afrezza failed in the US under SNY's control. The economics for the next partner has changed. MNKD is no longer selling in Neiman Marcus. ROW markets are Wal-Mart types. MNKD will not get the huge up front payments you are expecting. You are only guessing on COGS. Why would you create a model based on this? One question. How can Afrezza no longer be a fresh product that everyone wanted as you state when the vast majority of doctors and diabetics don't even KNOW IT EXISTS to this day? For example, today I asked a pharmacist at a major grocery store if she had heard of Afrezza, the inhaled insulin. She said it sounded familiar and "is it even approved yet?" I laughed. Only those who follow the stock seem to know it exists but many in the medical community still don't. If they don't, you can bet many diabetics don't.
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