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Post by 1 percenter on Jul 30, 2015 17:13:34 GMT -5
If there is going to be a buyout, either of Afrezza or Mannkind, Sanofi will only do so once they can clean up Afrezza label. We know that Mannkind was lobbying to get "less hypos" on the label and due to poor trial data that couldn't substantiate it, the FDA said no. I think a better label would have made Sanofi more inclined to buy Afrezza earlier but due to the current label, deal B was implented and that is what we have now. If Sanofi can get data to convince the FDA to accept a more glowing label, one that with overwhelming data that doctors can not ignore or explain away, then I think sanofi will feel much better forking over billions for the drug. If not, the deal as it stands will continue. If there is a buyout due to a new and improved label to Sanofi's liking, i envision a buyout by mid 2016 at the earliest. Until then, we continue to navigate choppy water.
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Post by dreamboatcruise on Jul 30, 2015 17:25:04 GMT -5
If there is going to be a buyout, either of Afrezza or Mannkind, Sanofi will only do so once they can clean up Afrezza label. We know that Mannkind was lobbying to get "less hypos" on the label and due to poor trial data that couldn't substantiate it, the FDA said no. I think a better label would have made Sanofi more inclined to buy Afrezza earlier but due to the current label, deal B was implented and that is what we have now. If Sanofi can get data to convince the FDA to accept a more glowing label, one that with overwhelming data that doctors can not ignore or explain away, then I think sanofi will feel much better forking over billions for the drug. If not, the deal as it stands will continue. If there is a buyout due to a new and improved label to Sanofi's liking, i envision a buyout by mid 2016 at the earliest. Until then, we continue to navigate choppy water. I agree that would seem the earliest. Given that we haven't yet seen the trial announced and it will take time to enroll and complete, it's still a good ways off. Unless there is some route to change the label without a new FDA registered trial. |
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Post by trenddiver on Jul 30, 2015 18:44:36 GMT -5
If there is going to be a buyout, either of Afrezza or Mannkind, Sanofi will only do so once they can clean up Afrezza label. We know that Mannkind was lobbying to get "less hypos" on the label and due to poor trial data that couldn't substantiate it, the FDA said no. I think a better label would have made Sanofi more inclined to buy Afrezza earlier but due to the current label, deal B was implented and that is what we have now. If Sanofi can get data to convince the FDA to accept a more glowing label, one that with overwhelming data that doctors can not ignore or explain away, then I think sanofi will feel much better forking over billions for the drug. If not, the deal as it stands will continue. If there is a buyout due to a new and improved label to Sanofi's liking, i envision a buyout by mid 2016 at the earliest. Until then, we continue to navigate choppy water. I agree that would seem the earliest. Given that we haven't yet seen the trial announced and it will take time to enroll and complete, it's still a good ways off. Unless there is some route to change the label without a new FDA registered trial. Time to stop the constant hype about this illusionary buy-out. Its just bunch of hopeful Pumpers pumping. There is no buyout on the horizon. It's way to early (at least 2 to 3 years off at best). There is no reason at this time for anybody to buy-out Mannkind right now because although the Technoshere/Afrezza platform might be the greatest invention since the IPhone, its has not in any way proven to be commercially successful. As a result, the price anyone would be willing to pay for Mannkind is nowhere near what Al Mann would want for Mannkind based on his own valuation of the company's worth, realistic or not. Conclusion - no sale any time soon.
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Post by dreamboatcruise on Jul 30, 2015 18:52:07 GMT -5
I agree that would seem the earliest. Given that we haven't yet seen the trial announced and it will take time to enroll and complete, it's still a good ways off. Unless there is some route to change the label without a new FDA registered trial. Time to stop the constant hype about this illusionary buy-out. Its just bunch of hopeful Pumpers pumping. There is no buyout on the horizon. It's way to early (at least 2 to 3 years off at best). There is no reason at this time for anybody to buy-out Mannkind right now because although the Technoshere/Afrezza platform might be the greatest invention since the IPhone, its has not in any way proven to be commercially successful. As a result, the price anyone would be willing to pay for Mannkind is nowhere near what Al Mann would want for Mannkind based on his own valuation of the company's worth, realistic or not. Conclusion - no sale any time soon.
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Ooops, sorry, didn't mean to seem to be jumping on the buyout hype wagon. My comment was purely about timeline for a label improvement. I've stated before that I think Al intends for this to be a permanent legacy, so I'm skeptical there will ever be a buyout. |
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Post by mnholdem on Jul 30, 2015 22:14:50 GMT -5
Ordinarily, I would agree. But the truth that is plain to see (although investors may be too timid to admit) is that Technosphere is not ordinary. TS possibilities are as far from ordinary as medicine has seen in nearly a century. The potential of this technology is staggering and EVERY pharmaceutical company knows it. They are not ignoring or discounting the testimony of Afrezza's early adopters using Technosphere's first entry into the marketplace. I think a monster deal is in the works and that we will see a record-breaking buyout of the entire company. Nite! (I mean it this time...  ) |
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Post by vestful on Jul 30, 2015 22:58:50 GMT -5
Ordinarily, I would agree. But the truth that is plain to see (although investors may be too timid to admit) is that Technosphere is not ordinary. TS possibilities are as far from ordinary as medicine has seen in nearly a century. The potential of this technology is staggering and EVERY pharmaceutical company knows it. They are not ignoring or discounting the testimony of Afrezza's early adopters using Technosphere's first entry into the marketplace. I think a monster deal is in the works and that we will see a record-breaking buyout of the entire company. Nite! (I mean it this time... ) Agree the potential is staggering! However, I think that BP needs more time to evaluate any possible risk vulnerability of inhalation and dont see mnkd willing to sell the entire Technosphere platform for what BP may be willing to pay at this time. My guess is it eventually gets pieced out or we are at least a couple of years from a combo deal. |
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Post by in search of the truth on Jul 31, 2015 7:41:16 GMT -5
From the perspective of the current price/value of the stock and getting improvements to the label, I agree that a BO looks un-likely. However, Mannkind is currently a shell of a company and has all but shut the company down, selling off headquarters, dispersing employees, no specifically identified TS applications since Afrezza approval, future pipeline of inhalable drugs seem to be "outsourced", golden parachutes approved in May for Mannkind execs and board members, additional funds allocated to acquire assets by SNY in May, so I can't imagine that things could stay as they are for two more years...
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Post by Deleted on Jul 31, 2015 8:36:42 GMT -5
Ordinarily, I would agree. But the truth that is plain to see (although investors may be too timid to admit) is that Technosphere is not ordinary. TS possibilities are as far from ordinary as medicine has seen in nearly a century. The potential of this technology is staggering and EVERY pharmaceutical company knows it. They are not ignoring or discounting the testimony of Afrezza's early adopters using Technosphere's first entry into the marketplace. I think a monster deal is in the works and that we will see a record-breaking buyout of the entire company. Nite! (I mean it this time... (zzz) ) I tend to agree with you about the monster deal of course when is the big question. Still a bit too early I think. Label improvement opens the floodgates for Afrezza as it makes it a no brainer for docs to prescribe and would get any lingering prior authorization requirements minimized / eliminated sooner rather than later even though they are slowly going by the wayside as we speak. We should know more about a TS deal or two by the end of the year. Maybe 2nd half of 2016 for the big deal? As far as trials to improve label - does anyone know if these can take place outside of the US? Also as part of that blackout of information MNKD had in one of their public filings, could it be related to label improvements for Afrezza or a TS trial / partnership? I am also interested in the SNY / MDT partnership. One byproduct of Afrezza's success could be an adverse impact on the insulin pump business if patients need one daily injection of Toujeo along with Afrezza, that would be much simpler than using a pump and all the work associated with doing so. Plus, less expensive as a new pump is around $6500 or so these days plus a new infusion set every 2-4 days. Does this not create a bit of friction between MDT and SNY? |
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Post by dreamboatcruise on Jul 31, 2015 13:35:20 GMT -5
Ordinarily, I would agree. But the truth that is plain to see (although investors may be too timid to admit) is that Technosphere is not ordinary. TS possibilities are as far from ordinary as medicine has seen in nearly a century. The potential of this technology is staggering and EVERY pharmaceutical company knows it. They are not ignoring or discounting the testimony of Afrezza's early adopters using Technosphere's first entry into the marketplace. I think a monster deal is in the works and that we will see a record-breaking buyout of the entire company. Nite! (I mean it this time... ) I tend to agree with you about the monster deal of course when is the big question. Still a bit too early I think. Label improvement opens the floodgates for Afrezza as it makes it a no brainer for docs to prescribe and would get any lingering prior authorization requirements minimized / eliminated sooner rather than later even though they are slowly going by the wayside as we speak. We should know more about a TS deal or two by the end of the year. Maybe 2nd half of 2016 for the big deal? As far as trials to improve label - does anyone know if these can take place outside of the US? Also as part of that blackout of information MNKD had in one of their public filings, could it be related to label improvements for Afrezza or a TS trial / partnership? I am also interested in the SNY / MDT partnership. One byproduct of Afrezza's success could be an adverse impact on the insulin pump business if patients need one daily injection of Toujeo along with Afrezza, that would be much simpler than using a pump and all the work associated with doing so. Plus, less expensive as a new pump is around $6500 or so these days plus a new infusion set every 2-4 days. Does this not create a bit of friction between MDT and SNY? If authorization requirements are currently going by the wayside, it is so slowly as to be imperceptible on formularylookup.com. Yes, FDA approved trials very often have lots of participants outside the U.S. The only question is whether a label improvement could happen from a trial that isn't registered as a trial with the FDA... or for that matter anywhere. None of the trials we know about seem structured to improve the U.S. label. MNKD has also stated that label improvement trials will be put in place after the mandated FDA trials... and we know those are not yet in place. So label improvement would seem to still be some ways off. Stuff blacked out in filings can theoretically be about anything. You'd need to read the context around what is blacked out to see if there are clues. If there are no clues, it becomes silly to speculate. |
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Post by EveningOfTheDay on Jul 31, 2015 14:10:01 GMT -5
I have to agree with DBC here. In addition, it does not look to me as if MNKD is setting itself for a buyout. On the contrary, it would seem they are setting themselves for a continued partnership. Of course a buy out could come at any time, but at this point I would see it as a bad sign if it comes sooner rather than later.
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Post by dudley on Jul 31, 2015 14:20:59 GMT -5
All this SNY buyout talk is just fantasy and a waste of time. Why in the world would Sanofi spend billions more to own a 100% of a drug for which they already have effective ownership of 65%? They will still have all the marketing and distribution costs and in addition will take on all the manufacturing cost. I would love to see the IRR on a multi-billion dollar purchase just to get a few extra points in margin that will take many years to pay back the investment. If they just run the drug properly they get 65% of all profits with only gradual incremental investment as milestone payments are reached - guaranteed the IRR for them is greater leaving the structure as is rather than sinking billions more into things to get the extra 35% ownership. Fuhgeddabout the buyout, it simply is not going to happen.
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Post by mannmade on Jul 31, 2015 14:24:05 GMT -5
All this SNY buyout talk is just fantasy and a waste of time. Why in the world would Sanofi spend billions more to own a 100% of a drug for which they already have effective ownership of 65%? They will still have all the marketing and distribution costs and in addition will take on all the manufacturing cost. I would love to see the IRR on a multi-billion dollar purchase just to get a few extra points in margin that will take many years to pay back the investment. If they just run the drug properly they get 65% of all profits with only gradual incremental investment as milestone payments are reached - guaranteed the IRR for them is greater leaving the structure as is rather than sinking billions more into things to get the extra 35% ownership. Fuhgeddabout the buyout, it simply is not going to happen. I have stated this many times previously on this Board. Completely agree... |
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Post by suebeeee1 on Jul 31, 2015 14:57:30 GMT -5
If Merck were really smart, they would buy Mannkind for technosphere alone. Team it up with their new Ebola vaccine and wala!. Off to Africa this super stable, no injecting product goes.
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Post by sportsrancho on Jul 31, 2015 15:10:38 GMT -5
sue, good point. Was just going to bring that up. As soon as they or someone else makes a reasonable offer what is SNY going to do? Al is in a good position. He who has the gold rules,-)
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Post by kc on Jul 31, 2015 16:04:50 GMT -5
I have said many time there are a lot of cash rich big Pharma's who could buy MannKind and it would not have much effect on the Afrezza deal. The Pharma industry is very incestuous so having another Pharma owning the company would be ok for Sanofi if they didn't want to match the offer. They own the rights to Afrezza but not to MannKind. I have said before that perhaps Regeneron would be a great buyer of MannKind. They seem to be very smart folks who know how to develop new drugs and this would look great in their portfolio of assets. Than you have Teva who is the 10,000lb gorilla in the generic space. They have a lot of cash. Can you imagine what they could do with converting some of the already FDA approved drugs into a technosphere world. Now Teva would have to get FDA approval and trials for an already approved drug so the timeline might not be as bad as starting from scratch.
The main takeaway is that MannKind is worth a lot more than today's value and we all should feel confident that whatever happens down the road we will see our invested value out of our shares. Now Hopefully a 10X bagger but who can guess the future.
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