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Post by mnholdem on Aug 6, 2015 15:46:11 GMT -5
I tink Sanofi will answer that question the moment they can ship Afrezza with there own insulin on board, it will round the product off and gives even greater % of the margin I don't know what the above means. Explanation? Afrezza is currently manufactured using human insulin from a company called Amphastar. Sanofi also happens to produce its own human insulin and eventually wants Afrezza be manufactured using Sanofi insulin as the Active Pharmaceutical Ingredient (API), which would lower the COGS if Sanofi sold its API to MannKind at cost. This insulin, however, must first be approved for use in Afrezza by the FDA (to sell it in the U.S.) and/or other drug approval agencies.
A lower COGS means more profit, especially when Afrezza starts being sold in the 120 countries where they currently sell drugs. Many of these countries demand lower retail pricing than is commonly used in the United States.
cusop suggests that Sanofi is limiting sales until its own insulin is approved. I think they'll use that insulin for Afrezza sold other countries, so I disagree.
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Post by kc on Aug 6, 2015 17:04:12 GMT -5
I think MNKD investors are generally edgy right now! As the PPS dropped today I got a very serious headache. Does anybody have a Technosphere with a migraine drug in it. I could use some instant relief |
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Post by notamnkdmillionaire on Aug 6, 2015 17:14:48 GMT -5
I think MNKD investors are generally edgy right now! As the PPS dropped today I got a very serious headache. Does anybody have a Technosphere with a migraine drug in it. I could use some instant relief Actually, Mannkind will announce their 2nd TS candidate will be for depression, specifically to treat Mannkind shareholders. |
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Post by mssciguy on Aug 6, 2015 17:14:51 GMT -5
I think MNKD investors are generally edgy right now! As the PPS dropped today I got a very serious headache. Does anybody have a Technosphere with a migraine drug in it. I could use some instant relief today was some of the most obvious manipulation ever, including canceled trades publicly listed on NASDAQ after hours (and 125,000 shares purchased).... Someone is buying at deep discounts and quite frankly I would not be surprised if the finance guy on the MNKD BOD has a hand in this. Enough is enough. Drop a million on a securities lawyer to stop this. |
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Post by nylefty on Aug 6, 2015 18:33:17 GMT -5
MNKD was down 2.86% today. Biotechs in general (IBB) were down 4.30%.
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Post by dudley on Aug 6, 2015 18:57:29 GMT -5
I don't know what the above means. Explanation? Afrezza is currently manufactured using human insulin from a company called Amphastar. Sanofi also happens to produce its own human insulin and eventually wants Afrezza be manufactured using Sanofi insulin as the Active Pharmaceutical Ingredient (API), which would lower the COGS if Sanofi sold its API to MannKind at cost. This insulin, however, must first be approved for use in Afrezza by the FDA (to sell it in the U.S.) and/or other drug approval agencies.
A lower COGS means more profit, especially when Afrezza starts being sold in the 120 countries where they currently sell drugs. Many of these countries demand lower retail pricing than is commonly used in the United States.
cusop suggests that Sanofi is limiting sales until its own insulin is approved. I think they'll use that insulin for Afrezza sold other countries, so I disagree.
I still am wracking my brain to figure out why they are not getting the Pfizer stockpile certified. That is $10 billion sales worth of product at ZERO cost of sales since it is already paid for. That's a decade worth of product or more and since insulin is the largest component of COGS it would make Afrezza one of the cheapest-to- manufacture insulins anywhere. It just makes no sense not to be using it when it is pure profit to both entities for them to do so. |
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Post by notamnkdmillionaire on Aug 6, 2015 19:03:29 GMT -5
Afrezza is currently manufactured using human insulin from a company called Amphastar. Sanofi also happens to produce its own human insulin and eventually wants Afrezza be manufactured using Sanofi insulin as the Active Pharmaceutical Ingredient (API), which would lower the COGS if Sanofi sold its API to MannKind at cost. This insulin, however, must first be approved for use in Afrezza by the FDA (to sell it in the U.S.) and/or other drug approval agencies.
A lower COGS means more profit, especially when Afrezza starts being sold in the 120 countries where they currently sell drugs. Many of these countries demand lower retail pricing than is commonly used in the United States.
cusop suggests that Sanofi is limiting sales until its own insulin is approved. I think they'll use that insulin for Afrezza sold other countries, so I disagree.
I still am wracking my brain to figure out why they are not getting the Pfizer stockpile certified. That is $10 billion sales worth of product at ZERO cost of sales since it is already paid for. That's a decade worth of product or more and since insulin is the largest component of COGS it would make Afrezza one of the cheapest-to- manufacture insulins anywhere. It just makes no sense not to be using it when it is pure profit to both entities for them to do so. I can only think the issue is the age of the insulin. The FDA typically puts a time limit on how long something can be frozen. For instance, the FDA allows frozen human plasma for injection a life span of 10 years from time of collection as long as it is kept at -20 degrees or below. I would assume frozen insulin would have the same guidelines. Another thing to consider is that Mannkind thought they'd have Afrezza on the market ~3 years ago and that this wouldn't be an issue. That 2nd CRL really screwed the company up. |
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Post by mssciguy on Aug 6, 2015 19:12:12 GMT -5
I still am wracking my brain to figure out why they are not getting the Pfizer stockpile certified. That is $10 billion sales worth of product at ZERO cost of sales since it is already paid for. That's a decade worth of product or more and since insulin is the largest component of COGS it would make Afrezza one of the cheapest-to- manufacture insulins anywhere. It just makes no sense not to be using it when it is pure profit to both entities for them to do so. I can only think the issue is the age of the insulin. The FDA typically puts a time limit on how long something can be frozen. For instance, the FDA allows frozen human plasma for injection a life span of 10 years from time of collection as long as it is kept at -20 degrees or below. I would assume frozen insulin would have the same guidelines. Another thing to consider is that Mannkind thought they'd have Afrezza on the market ~3 years ago and that this wouldn't be an issue. That 2nd CRL really screwed the company up. Plasma is an extremely complex liquid product. The insulin surely is in crystalline form. Completely different, especially at -70 degrees Celsius. Nearly anything can last forever in crystalline form at those temperatures. FDA is not the smartest agency in the world. When I was looking for anti-dementia drugs for my parents, I had to import them from Europe. Just like SEC, there is a lot of corporate influence over FDA. Most of our science came from Europe, I would expect them to be smarter. |
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Post by kc on Aug 6, 2015 19:27:38 GMT -5
Afrezza is currently manufactured using human insulin from a company called Amphastar. Sanofi also happens to produce its own human insulin and eventually wants Afrezza be manufactured using Sanofi insulin as the Active Pharmaceutical Ingredient (API), which would lower the COGS if Sanofi sold its API to MannKind at cost. This insulin, however, must first be approved for use in Afrezza by the FDA (to sell it in the U.S.) and/or other drug approval agencies.
A lower COGS means more profit, especially when Afrezza starts being sold in the 120 countries where they currently sell drugs. Many of these countries demand lower retail pricing than is commonly used in the United States.
cusop suggests that Sanofi is limiting sales until its own insulin is approved. I think they'll use that insulin for Afrezza sold other countries, so I disagree.
I still am wracking my brain to figure out why they are not getting the Pfizer stockpile certified. That is $10 billion sales worth of product at ZERO cost of sales since it is already paid for. That's a decade worth of product or more and since insulin is the largest component of COGS it would make Afrezza one of the cheapest-to- manufacture insulins anywhere. It just makes no sense not to be using it when it is pure profit to both entities for them to do so. Dudley, perhaps that Insulin can be used in a needy 3rd world nation at a reduced price to get entry where they might not otherwise gain access or perhaps it will be used for UK/ EMA since it came from Germany to begin with at the plant that is now Owned by Sanofi. |
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Post by dudley on Aug 6, 2015 19:33:26 GMT -5
Afrezza is currently manufactured using human insulin from a company called Amphastar. Sanofi also happens to produce its own human insulin and eventually wants Afrezza be manufactured using Sanofi insulin as the Active Pharmaceutical Ingredient (API), which would lower the COGS if Sanofi sold its API to MannKind at cost. This insulin, however, must first be approved for use in Afrezza by the FDA (to sell it in the U.S.) and/or other drug approval agencies.
A lower COGS means more profit, especially when Afrezza starts being sold in the 120 countries where they currently sell drugs. Many of these countries demand lower retail pricing than is commonly used in the United States.
cusop suggests that Sanofi is limiting sales until its own insulin is approved. I think they'll use that insulin for Afrezza sold other countries, so I disagree.
I still am wracking my brain to figure out why they are not getting the Pfizer stockpile certified. That is $10 billion sales worth of product at ZERO cost of sales since it is already paid for. That's a decade worth of product or more and since insulin is the largest component of COGS it would make Afrezza one of the cheapest-to- manufacture insulins anywhere. It just makes no sense not to be using it when it is pure profit to both entities for them to do so. I distinctly remember Matt saying (way too many conferences now to remember which one) that the insulin was still good and that all it required was FDA certification and that it was not a particularly burdensome thing to get. That was sometime in the past year. If the insulin can produce $10 Billion in sales just that raw product and MNKD loss carryforwards would be extremely valuable to an acquirer. If I can manage to get up early enough and actually get on the call I am going to try to ask that question. It is just a hugely valuable asset and almost always overlooked. |
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Post by mannmade on Aug 6, 2015 21:01:51 GMT -5
There must be a reason as otherwise they would not have likely signed the Amphastar deal also knowing the Sanofi plans at some point to start supplying the insulin for Afrezza as well.
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Post by babaoriley on Aug 7, 2015 1:14:44 GMT -5
Perhaps they are using it, just haven't disclosed that. Perhaps the FDA said no, and that hasn't been disclosed either (not sure how they were carrying that on their books, but, depending, it might not be material). Perhaps, due to age, it's usable, but a bit more risky in terms of full efficacy - they wouldn't want less than full efficacy Afrezza out there right now, that's for sure. I don't think they've forgotten about it.
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