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Post by dpca10 on Nov 16, 2015 11:59:31 GMT -5
Does anyone have information on this topic? It seems qualifying sny's insulin should be a realistically easy process. After all we are just talking about raw material already in use, correct? This could be a major catalyst considering it comes with a $25m payment and increases profit margins significantly I would think.
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Post by jurystillout on Nov 16, 2015 14:20:14 GMT -5
I really don't know why there is any focus on getting sny insulin in the mix at this point in time, we have a committed deal with amphistar to supply more insulin than we can utilize, is MNKD planning to default on this agreement? What will the penalties be, more than the saving on using SNY insulin? It seems to me like they're getting the cart in front of the horse, They should be focused on selling the product, once we see enough volume that will allow us to honestly get out of the amphistar deal then they can look at SNY insulin, until that time it seems like a poor use of precious time. This is one of those areas that we just don't have enough information to decide if management is making good or bad decisions. We know they're doing it why not explain why they're doing this now and the business case behind the decision, it might be very positive news that could help shareholders and themselves.
On a more cynical note, I don't like the control SNY has over MNKD now, if mnkd alienates Amphistar, mnkd is all the more bound to SNY. SNY benefits more than mnkd if they use SNY insulin, MNKD should be using this as a negotiating tool to get SNY to step up sales.
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Post by lakers on Nov 16, 2015 15:55:07 GMT -5
EU, ME expansion 1Q16. Amph's France plant, and Sny's Germany plant supply insulin. Sny must have anticipated a hockey stick ... Amph's q3 insulin rev was $6M. They anticipated a make-up purchase in Q4. There is a penalty if min annual purchase is not met. seekingalpha.com/article/3681646-amphastar-pharmaceuticals-amph-q3-2015-results-earnings-call-transcript?part=single Our Insulin API business generated sales of $6 million which was the same amount as we sold in the third quarter of 2014. The timing of certain insulin shipments is variable and depending on other couple of different factors. Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz3rgrpu79a |
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Post by jurystillout on Nov 17, 2015 9:19:53 GMT -5
Thanks Lakers, I don't know how you keep all these threads straight. I understand that there is a milestone payment associated with getting SNY insulin approved, however it seems to me that if they get the SNY insulin approved now and use it instead of the AMPH insulin the milestone payment will be diluted due to paying the amph penalty, however if the wait until the AMPH contract has been satisfied they get the full benefit of the milestone payment. It could however be that MNKD is expecting to pay the penalty no matter what (volume committed to will not be met) and they are just trying to raise cash. Then again what happens if they get the milestone payment, and continue to use the amph insulin until the contract is satisfied?? They get full benefit of milestone payment, hopefully no penalty and a pissed off SNY. So much we don't know.
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Post by lakers on Nov 17, 2015 10:58:28 GMT -5
Thanks Lakers, I don't know how you keep all these threads straight. I understand that there is a milestone payment associated with getting SNY insulin approved, however it seems to me that if they get the SNY insulin approved now and use it instead of the AMPH insulin the milestone payment will be diluted due to paying the amph penalty, however if the wait until the AMPH contract has been satisfied they get the full benefit of the milestone payment. It could however be that MNKD is expecting to pay the penalty no matter what (volume committed to will not be met) and they are just trying to raise cash. Then again what happens if they get the milestone payment, and continue to use the amph insulin until the contract is satisfied?? They get full benefit of milestone payment, hopefully no penalty and a pissed off SNY. So much we don't know. Hockey stick ... Prep for new markets ... Sny wants to supply insulin for Afrezza on top of Amph's 5 year supply shows commitment and expansion plan. MNKD also signed an option to buy more from Amph. You can verify easily. |
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Post by bradleysbest on Nov 17, 2015 11:49:29 GMT -5
Well it sure sounds like SNY has big plans for Afrezza.....
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Post by rrtzmd on Nov 17, 2015 12:33:51 GMT -5
Does anyone have information on this topic? It seems qualifying sny's insulin should be a realistically easy process. After all we are just talking about raw material already in use, correct? This could be a major catalyst considering it comes with a $25m payment and increases profit margins significantly I would think. Indeed, SNY sells tons of insulin in the US, I would think little more than a phone call to the FDA would have been sufficient. After all, afrezza uses just humalin R -- nothing fancy. And, as I understand it, MNKD has a warehouse full of Pfizer insulin that could be "qualified" as well. I have yet to understand why MNKD would allow itself to be bound to an agreement with Amphastar for five years before anyone had a remote idea of what the demand would be. If anything, why wasn't it SNY that signed the deal with Amphastar so "qualified" insulin could be provided to MNKD? SNY is in much better condition to handle any supply/demand issues than MNKD, plus it would have been an incentive for SNY to put more energy into promoting afrezza. |
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Post by peppy on Nov 17, 2015 12:43:07 GMT -5
Does anyone have information on this topic? It seems qualifying sny's insulin should be a realistically easy process. After all we are just talking about raw material already in use, correct? This could be a major catalyst considering it comes with a $25m payment and increases profit margins significantly I would think. Indeed, SNY sells tons of insulin in the US, I would think little more than a phone call to the FDA would have been sufficient. After all, afrezza uses just humalin R -- nothing fancy. And, as I understand it, MNKD has a warehouse full of Pfizer insulin that could be "qualified" as well. I have yet to understand why MNKD would allow itself to be bound to an agreement with Amphastar for five years before anyone had a remote idea of what the demand would be. If anything, why wasn't it SNY that signed the deal with Amphastar so "qualified" insulin could be provided to MNKD? SNY is in much better condition to handle any supply/demand issues than MNKD, plus it would have been an incentive for SNY to put more energy into promoting afrezza. Think again. |
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Post by rrtzmd on Nov 17, 2015 13:07:43 GMT -5
Indeed, SNY sells tons of insulin in the US, I would think little more than a phone call to the FDA would have been sufficient. After all, afrezza uses just humalin R -- nothing fancy. And, as I understand it, MNKD has a warehouse full of Pfizer insulin that could be "qualified" as well. I have yet to understand why MNKD would allow itself to be bound to an agreement with Amphastar for five years before anyone had a remote idea of what the demand would be. If anything, why wasn't it SNY that signed the deal with Amphastar so "qualified" insulin could be provided to MNKD? SNY is in much better condition to handle any supply/demand issues than MNKD, plus it would have been an incentive for SNY to put more energy into promoting afrezza. Think again. I did, but nothing changed. Do you have any additional insight to offer? Has MNKD ever specified what exactly is required to get insulin qualified? From Morgan Stanley conference (9/14): “It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors. “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.” However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “It is not terribly complex, but it takes some time.” Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner." So it's been 14 months since Pfeffer said "it takes some time." How much more time should be anticipated? After the Amphastar agreement runs out in four years? Currently, at least, it doesn't appear that Sanofi "would like to supply" insulin to MNKD. |
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Post by peppy on Nov 17, 2015 13:22:33 GMT -5
I did, but nothing changed. Do you have any additional insight to offer? Has MNKD ever specified what exactly is required to get insulin qualified? From Morgan Stanley conference (9/14): “It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors. “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.” However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “ It is not terribly complex, but it takes some time.” Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner." So it's been 14 months since Pfeffer said "it takes some time." How much more time should be anticipated? After the Amphastar agreement runs out in four years? Currently, at least, it doesn't appear that Sanofi "would like to supply" insulin to MNKD. Quote: Do you have any additional insight to offer? if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. Reply; Yes, I do have additional insight. You said it would take a phone call and then you posted it takes more than a phone call. I see you thought about it enough to find out, it takes more than a phone call. This discussion is over for me.
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Post by rrtzmd on Nov 17, 2015 23:50:18 GMT -5
I did, but nothing changed. Do you have any additional insight to offer? Has MNKD ever specified what exactly is required to get insulin qualified? From Morgan Stanley conference (9/14): “It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors. “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.” However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “ It is not terribly complex, but it takes some time.” Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner." So it's been 14 months since Pfeffer said "it takes some time." How much more time should be anticipated? After the Amphastar agreement runs out in four years? Currently, at least, it doesn't appear that Sanofi "would like to supply" insulin to MNKD. Quote: Do you have any additional insight to offer? if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. Reply; Yes, I do have additional insight. You said it would take a phone call and then you posted it takes more than a phone call. I see you thought about it enough to find out, it takes more than a phone call. This discussion is over for me.
"You said it would take a phone call..." No, I said I thought it would take little more than a "phone call" given the huge amount of insulin SNY already sells in the United States. Does anyone see any reason why it should take 14 months or longer? Is SNY even attempting to get qualified to supply insulin to MNKD? |
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Post by trenddiver on Nov 18, 2015 0:18:16 GMT -5
Quote: Do you have any additional insight to offer? if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. Reply; Yes, I do have additional insight. You said it would take a phone call and then you posted it takes more than a phone call. I see you thought about it enough to find out, it takes more than a phone call. This discussion is over for me.
"You said it would take a phone call..." No, I said I thought it would take little more than a "phone call" given the huge amount of insulin SNY already sells in the United States. Does anyone see any reason why it should take 14 months or longer? Is SNY even attempting to get qualified to supply insulin to MNKD? Rrtz Just wondering why you are here? Do you own shares? Are you short? I have yet to see any post from you other than a negative slant. I not saying that your soft bashing isn't welcome or that from time to time you don't raise an interesting point to two, but what is your purpose here. Trend |
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Post by EveningOfTheDay on Nov 18, 2015 14:39:55 GMT -5
Unfortunately, the black hole surrounding everything Mannkind gives posters like Rrtz, if not credibility, yes a soap box from where to keep spreading FUD. In any case, whether a short, a paid baser, or just some sort of MB lurking organism without much else to do his agenda is pretty clear.
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Post by mindovermatter on Nov 18, 2015 14:47:21 GMT -5
Unfortunately, the black whole surrounding everything Mannkind gives posters like Rrtz, if not credibility, yes a soap box from where to keep spreading FUD. In any case, whether a short, a paid baser, or just some sort of MB lurking organism without much else to do his agenda is pretty clear. I keep reading about FUD and those who post not so flattering posts about Mannkind. What determines what is FUD vs what is a real and genuine criticism of the company? Is the "FUD" from message boards the reason why Wall Street is so negative on the company and why Afrezza isn't selling like many of us thought it would? Help me understand why there is such a concern for those who post unflattering things about Mannkind because in the grand picture, it's just white noise and has nothing to do with why the stock has been a popular pinata for Wall Street to smack around. |
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Post by EveningOfTheDay on Nov 18, 2015 15:00:52 GMT -5
I keep reading about FUD and those who post not so flattering posts about Mannkind. What determines what is FUD vs what is a real and genuine criticism of the company? Is the "FUD" from message boards the reason why Wall Street is so negative on the company and why Afrezza isn't selling like many of us thought it would? Help me understand why there is such a concern for those who post unflattering things about Mannkind because in the grand picture, it's just white noise and has nothing to do with why the stock has been a popular pinata for Wall Street to smack around. I guess we all have different standards. I have been around long enough to recognize, in my personal opinion, who mostly posts baseless info, whether that info is positive or negative. Furthermore, I have very little doubt that HF in wall street use all kind of strategies to dictate a stock's price behavior. Some of those strategies include pushing disinformation destined to create fear and uncertainty. Yes, you are right that one poster will have little to no effect on the stock price. Repeat this across the board (referring to all information outlets) hundreds or thousands of times while you constantly maintain downward pressure on the price, and it is clear that, barred from unforeseen positive events, the price of a stock in certain sectors of the market or at certain stages in the life of a company can be greatly manipulated. Volatility is a really good way to make quick money if you have a hand in creating it. Of course that is just my opinion, you are more than welcome to believe something entirely different. In any case I do agree with you that, when using a very long term outlook, FUD turns simply into white noise. |
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