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Post by lakon on Jul 18, 2016 12:35:18 GMT -5
So we purchased insulin in 2009 from Pfizer for $3 million and it's now projected to be worth $10 billion? Is this the Yahoo board? No, this is no Yahoo. Strange as it may seem, yes, that's exactly correct. The difference is in the cost of the insulin API and the street value of Afrezza (insulin human). It's interesting because the estimate is actually conservative, and the estimate can be useful in performing ones due diligence when attempting to figure out the cost to manufacture Afrezza. It had been noted before that most of the cost comes from the API.
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Post by chuck on Jul 18, 2016 13:32:40 GMT -5
Having enough insulin to create $10 billion worth of marketable AFREZZA isn't the same as saying the insulin is worth $10 billion. In the absence of sales, the insulin is worth only the possibility there might be sales to be able to use it. Considering their existing purchase commitments from their existing supplier, absent a miracle, it seems hard to believe they would ever use this insulin. My model has a zero value on this insulin.
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Post by tingtongtung on Jul 18, 2016 13:44:08 GMT -5
I'm sure this has been asked (and answered) a million time before..
Why did MNKD strike up a deal to buy Insulin from Amphastar for several years, when they had (have) so much insulin from Pfizer? Are they different types of Insulins?
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Post by lakon on Jul 18, 2016 15:19:59 GMT -5
Having enough insulin to create $10 billion worth of marketable AFREZZA isn't the same as saying the insulin is worth $10 billion. In the absence of sales, the insulin is worth only the possibility there might be sales to be able to use it. Considering their existing purchase commitments from their existing supplier, absent a miracle, it seems hard to believe they would ever use this insulin. My model has a zero value on this insulin. Your model seems to fit with the street's model from $0-3 million. Obviously, MNKD would likely take a loss if they had to sell the insulin as-is instead of as Afrezza. Because of the obviously low valuation given by the market for this insulin, there is potential hidden value. IF it all becomes sold as Afrezza, your model is very wrong, and I am very rich. That makes a market.
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Post by lakon on Jul 18, 2016 15:25:36 GMT -5
I'm sure this has been asked (and answered) a million time before.. Why did MNKD strike up a deal to buy Insulin from Amphastar for several years, when they had (have) so much insulin from Pfizer? Are they different types of Insulins? In fact, it was even answered in this thread, but I'll be nice and answer it again. The insulin [API] to make Afrezza must be approved by the FDA. The only approved API for Afrezza is from Amphastar. Insulin may seem like insulin to you, but it's not that simple in the land of the FDA.
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Post by agedhippie on Jul 18, 2016 16:04:45 GMT -5
As I remember the $3 million paid was for a quantity intended to produce an initial quantity of Afrezza and an option of the remainder. Mannkind also agreed to maintain storage of the remaining insulin for Pfizer. The supply contract details are out there but I don't have access at the moment. The $10 billion figure assumes the option is exercised and the whole supply is taken up. As much as anything it is a reflection on how cheap human insulin is - the insulin cost is a small component of the street price of Afrezza.
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Post by prosper on Jul 18, 2016 16:34:35 GMT -5
I seem to remember posts discussing the possible deterioration of this over time. Can't remember if here or some clown on YMB inventing problems. While we need FDA approval in USA, I doubt MNKD, in the spirit of Al, would sell something not 100% viable and safe. Does anyone here have the professional expertise to evaluate the longevity of the P insulin in frozen storage?
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Post by esstan2001 on Jul 18, 2016 16:55:29 GMT -5
I seem to remember posts discussing the possible deterioration of this over time. Can't remember if here or some clown on YMB inventing problems. While we need FDA approval in USA, I doubt MNKD, in the spirit of Al, would sell something not 100% viable and safe. Does anyone here have the professional expertise to evaluate the longevity of the P insulin in frozen storage? The company tests the insulin in storage on a regular basis (and maintains records in case of later FDA submission) to determine it's continued viability for use, per the 2015 Danbury factory tour.
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Post by matt on Jul 18, 2016 17:14:32 GMT -5
Does anyone here have the professional expertise to evaluate the longevity of the P insulin in frozen storage? I can't speak to the chemical stability of insulin per se, but I have experience with a lot of other proteins. When you do stability testing, there is a maximum life that FDA will allow on the label but the API can be retested and recertified periodically. I have worked with proteins where our company owned the entire world supply of a particular protein for which manufacturing had been discontinued more than ten years before. Every few years my QA and Regulatory guy would test a sample, recertify it, and life would go on as before. We used this item in production of our product, which was also FDA licensed, but I was told the same applies to API that is past its sell-by date; if a stability test shows that the protein has not degraded you can use it indefinitely. Obviously only the manufacturer is in a position to do that; once the product goes out the door it must have an expiration date affixed.
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Post by seanismorris on Jul 18, 2016 18:57:51 GMT -5
Until there is a clinical trial showing the insulin from Pfizer is equivalent to Amphastar MannKinds stockpile is worthless...
Why this hasn't been done already is unknown, but they've had to have done some kind of comparison in house...which leads me to believe the value is zero.
There are all kinds of studies that should have been completed by now but haven't been done. Pediatric, Superiority, etc.
I've never heard an adequate explanation for MannKinds management about any of it...
Discussing the amazing PK profile is worthless, unless Docs can paper their asses with FDA approved results and Labels.
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Post by ilovekauai on Jul 18, 2016 19:06:51 GMT -5
Gosh, sounds hopeless IYO. IMO it's a great time to add. Go MNKD!
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Post by liane on Jul 18, 2016 19:16:56 GMT -5
The Pfizer insulin is just fine in storage for now. Everything costs money that the company simply does not have. They are appropriately focused on increasing the Rx counts and subsequently the revenue.
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Post by brotherm1 on Jul 18, 2016 22:30:46 GMT -5
Until there is a clinical trial showing the insulin from Pfizer is equivalent to Amphastar MannKinds stockpile is worthless... Why this hasn't been done already is unknown, but they've had to have done some kind of comparison in house...which leads me to believe the value is zero. There are all kinds of studies that should have been completed by now but haven't been done. Pediatric, Superiority, etc. I've never heard an adequate explanation for MannKinds management about any of it... Discussing the amazing PK profile is worthless, unless Docs can paper their asses with FDA approved results and Labels. Is it true a clinical trial needs to be done with the insulin purchased from Pfizer before it can be used to make Afrezza? If so, what kind of trial and how much would the trial cost? Hungman? Lakon? Anyone?
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