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Post by notamnkdmillionaire on Aug 1, 2015 19:08:10 GMT -5
With news of line 2 and 3 now operational and validated, could Sanofi's strategy actually be Europe and the Middle East to boost Afrezza sales while the US market slowly ripens? My theory, and only a theory that might have been posted by someone else on here and I missed it, is that Sanofi's plan all along was not to get the US sales off and running but to get the other pieces in place -- such as the new lines to produce Afrezza -- for launch in Europe and/or Middle East. Sanofi knew that getting insurance companies and docs in the US on board was going to take time. But Europe and the Middle East is an entirely different beast by that much of it is done by the state and not by insurance companies. As long as the Health Ministries in <pick your country> give Afrezza the green light, Sanofi might know that Afrezza will be a much easier script over there than here. With Danbury now able to triple their production, could we soon see other countries green light Afrezza once Sanofi/Mannkind have the inventory to ship there? I am not saying this is going to play out but I wouldn't be surprised if Sanofi knows the demand over in EUR/ME is a lot stronger than what we are seeing here and without the insurance/doctor hurdles that are now hamstring Afrezza. We shall see. But I hope this happens. Remember that off the cuff remark by Al stating that there was some over seas country ready to buy a boat load of Afrezza? |
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Post by jpg on Aug 1, 2015 19:47:46 GMT -5
Well a few 'details' to consider:
Afrezza isn't approved in Europe. There has been no request for approval either. If and when approved NICE and other European bodies that decide which drugs do or don't get paid for from public funds are usually rather slow and play hard ball on price vs benefit. European doctors aren't centrally controlled drones that will start prescribing Afrezza (but they might be a bit less conservative and open to innovation than American endos: not hard to beat though). As a side note it's kind of surprising that you as a hard core anti socialist (maybe I'm completely off base on this?) is looking to socialized medicine (or your perception of it) as a saviour?
As for the Middle East: most of it is poor, being actively bombed or in the middle of a security 'issue'. The Gulf countries are rich and have lots of diabetics and follow the FDA's lead so there's definitely some possibility there. But their doctors tend to follow US trends.
Japan was mentioned early by Sanofi as a potential good market but I don't know how that country does drug approvals?
All in all it's only been 6 months. In medical times 'this treatment just came out yesterday'. Sanofi knows this, doctors know this, the competition knows this. Sadly retail longs don't and are looking at some rather wacky scenarios to fill the gap in disconnect. Sorry but counting on Europeans for a near term boost in sales is just not logical.
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Post by mrhaigs on Aug 1, 2015 23:09:05 GMT -5
With news of line 2 and 3 now operational and validated, could Sanofi's strategy actually be Europe and the Middle East to boost Afrezza sales while the US market slowly ripens? My theory, and only a theory that might have been posted by someone else on here and I missed it, is that Sanofi's plan all along was not to get the US sales off and running but to get the other pieces in place -- such as the new lines to produce Afrezza -- for launch in Europe and/or Middle East. Sanofi knew that getting insurance companies and docs in the US on board was going to take time. But Europe and the Middle East is an entirely different beast by that much of it is done by the state and not by insurance companies. As long as the Health Ministries in <pick your country> give Afrezza the green light, Sanofi might know that Afrezza will be a much easier script over there than here. With Danbury now able to triple their production, could we soon see other countries green light Afrezza once Sanofi/Mannkind have the inventory to ship there? I am not saying this is going to play out but I wouldn't be surprised if Sanofi knows the demand over in EUR/ME is a lot stronger than what we are seeing here and without the insurance/doctor hurdles that are now hamstring Afrezza. We shall see. But I hope this happens. Remember that off the cuff remark by Al stating that there was some over seas country ready to buy a boat load of Afrezza? Why would sanofi not want to get US sales off and running? Come on man. They want sales off and running everywhere but it isn't happening. I would normally say yet right here but by god how flat and slow can this launch go??? |
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Post by jimo on Aug 2, 2015 6:04:00 GMT -5
This is the biggest blind spot I have and makes me nervous. I'm in 4.5 years and think frequently to determine what my trigger is to end this investment. MNKD is in the dark on Sanofi's intentions and strategy which is THE concern for me. After the CEO got fired I think many things changed that impacted the focus & priority of Afrezza at Sanofi.
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Post by falconquest on Aug 2, 2015 7:32:25 GMT -5
Bingo jimo! You just hit on a major point that I have been trying to make. What was the vision for Afrezza under Viebacher and what is it now under Brandicourt? This is the major factor that has changed. We now have no idea where we are headed and while we didn't have a lot of information under Viebacher, we also hadn't been past the 6 month mark for DTC advertising when the change occurred either. I can't help but wonder where we would be if Viebacher were still at the Helm. For what it's worth, one of my largest customers is a French firm and their decision making process is simply deplorable!
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Post by sportsrancho on Aug 2, 2015 9:41:09 GMT -5
jpg.... I think I know the truth when I hear it:-). ( All and all it's only been 6 months!) That makes the most sense to me. I said in another post if I was trading this stock I would be out of it right now. But I'm not trading it. I'm holding because I think holding is safer ( with MNKD ) than trading in and out. Time is what we need. Thanks for all your insight!
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Post by afrizzle on Aug 2, 2015 9:54:24 GMT -5
This is the biggest blind spot I have and makes me nervous. I'm in 4.5 years and think frequently to determine what my trigger is to end this investment. MNKD is in the dark on Sanofi's intentions and strategy which is THE concern for me. After the CEO got fired I think many things changed that impacted the focus & priority of Afrezza at Sanofi. What is the basis for your conclusion that MannKind is in the dark regarding Sanofis strategy? I'd agree we are in the dark, but MannKind has equal representation on the joint marketing marketing steering committee. |
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Post by centralcoastinvestor on Aug 2, 2015 10:02:23 GMT -5
Well a few 'details' to consider: Afrezza isn't approved in Europe. There has been no request for approval either. If and when approved NICE and other European bodies that decide which drugs do or don't get paid for from public funds are usually rather slow and play hard ball on price vs benefit. European doctors aren't centrally controlled drones that will start prescribing Afrezza (but they might be a bit less conservative and open to innovation than American endos: not hard to beat though). As a side note it's kind of surprising that you as a hard core anti socialist (maybe I'm completely off base on this?) is looking to socialized medicine (or your perception of it) as a saviour? As for the Middle East: most of it is poor, being actively bombed or in the middle of a security 'issue'. The Gulf countries are rich and have lots of diabetics and follow the FDA's lead so there's definitely some possibility there. But their doctors tend to follow US trends. Japan was mentioned early by Sanofi as a potential good market but I don't know how that country does drug approvals? All in all it's only been 6 months. In medical times 'this treatment just came out yesterday'. Sanofi knows this, doctors know this, the competition knows this. Sadly retail longs don't and are looking at some rather wacky scenarios to fill the gap in disconnect. Sorry but counting on Europeans for a near term boost in sales is just not logical. I think you hit the nail on the head with the following statement: "All in all it's only been 6 months. In medical times 'this treatment came out yesterday'. Sanofi knows this, doctors know this. Sadly retail investors don't ...." I have been in this stock for 8 years. From my perspective, Afrezza has been around forever. But to the medical world, it's brand new. That is the single biggest problem for retail longs, perception. That is what the bashers and shorts use to scare retail longs into selling. |
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Post by notamnkdmillionaire on Aug 2, 2015 10:13:16 GMT -5
Well a few 'details' to consider: Afrezza isn't approved in Europe. There has been no request for approval either. If and when approved NICE and other European bodies that decide which drugs do or don't get paid for from public funds are usually rather slow and play hard ball on price vs benefit. European doctors aren't centrally controlled drones that will start prescribing Afrezza (but they might be a bit less conservative and open to innovation than American endos: not hard to beat though). As a side note it's kind of surprising that you as a hard core anti socialist (maybe I'm completely off base on this?) is looking to socialized medicine (or your perception of it) as a saviour? As for the Middle East: most of it is poor, being actively bombed or in the middle of a security 'issue'. The Gulf countries are rich and have lots of diabetics and follow the FDA's lead so there's definitely some possibility there. But their doctors tend to follow US trends. Japan was mentioned early by Sanofi as a potential good market but I don't know how that country does drug approvals? All in all it's only been 6 months. In medical times 'this treatment just came out yesterday'. Sanofi knows this, doctors know this, the competition knows this. Sadly retail longs don't and are looking at some rather wacky scenarios to fill the gap in disconnect. Sorry but counting on Europeans for a near term boost in sales is just not logical. All your points are valid and I agree but did you miss my main point and theory that Sanofi thinks other markets might be quicker to adopt Afrezza once approved in their markets than the US? |
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Post by jpg on Aug 2, 2015 11:13:37 GMT -5
All in all it's only been 6 months. In medical times 'this treatment just came out yesterday'. Sanofi knows this, doctors know this, the competition knows this. Sadly retail longs don't and are looking at some rather wacky scenarios to fill the gap in disconnect. All your points are valid and I agree but did you miss my main point and theory that Sanofi thinks other markets might be quicker to adopt Afrezza once approved in their markets than the US? I will repeat what I have been saying (discreatly till recently) for since before the launch: it will take time. And I am quoting a Sanofi exec who was, I think, talking to Mannkind investors and not Sanofi investors when he said that. I used to read all the talk of running out of capacity in the first week, month etc and how Mannkind and Sanofi were irresponsible for not starting this off with at least 3 lines running. The screams of multi billion in the first year or two were so pervasive that I started to think I just didn't get it or something. These experts knew something about doctors, patients and new drugs that I didn't. Well it didn't turn out that way. Afrezza is a paradigm shift but as with most new paradigm shifts it's new and hard to figure out or understand... People aren't aware and rightfully skeptical so not lined up waiting for the new thing. It took me over a year of think ing and reading about it just to buy just my first few shares! I really doubt most users and MDs did as much (or will do as much) research before giving it a thumbs up or down as I did. Which brings us back to the cautious stamp of approval of opinion leaders (see article below). These opinion leaders are slow to give their blessings (and nowhere as conservative and slow as in the endo world maybe). I recently read something about when electricity came around: what a temporary trend that was supposed to be! Just for show and useless really. As a teenager I personally used to laugh at people with cell phones and computers plugged into the internet (whatever that thing trendy temporary thing was). Does anyone thinks Afrezza will catch on faster than the internet, cell phones or electricity? The details differ but the point is the same: in medical terms (and in innovation at large) Afrezza came out yesterday. The problem is with retail longs looking at script number week to week and not with anything Sanofi is doing. I remember those calling for SuperBowl adds on the launch. Does anyone not look back and kind of shake their head at how much of a waste of money that would have been? No MD awareness, no insurance coverage, no user experience and we spend millions on TV adds? I'm glad Sanofi is in charge of this. Basically I do not agree that Sanofi is looking at other markets because there is only one market: a world wide market and the US is one of the gateway to it. The below article is a baby step to what I think Afrezza needs to get us where we want to go. The author and editors have to believe in the possibility that Afrezza is the real deal before even accepting to ask the question and publish it. Same with those conservative endos (and again are they ever a conservative almost fearful of change bunch: but that would be a whole topic in itself). Again: This will take time. See below for article posted by Brentie: Is the Inhaled-Insulin Afrezza the Real Deal? www.diabetesdaily.com/blog/2015/06/is-the-inhaled-insulin-afrezza-the-real-deal/Read more: mnkd.proboards.com/thread/3137/inhaled-insulin-afrezza-real-deal#ixzz3hfj6FOSG |
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Post by jimo on Aug 2, 2015 11:30:00 GMT -5
My info comes from interacting with Sanofi reps this past spring when their tuned changed and reading what others say about their interactions with Sanofi reps regarding priority vs Toujeo and coverage. Another glaring issue with Sanofi comes from Hakan and Matt saying in May (I think that was the call) that script #s are 8 weeks behind their projections. How did they get so disconnected from Sanofi's performance just 4 months into a launch? Script growth has been flat the past 8 weeks so how many months behind are script numbers now based on Mannkinds projections? I'm guessing 4 months behind now and will be interesting to see if the comment on this Monday. For those saying it's not Sanofi I completely disagree as Sanofi presents the greatest risk for me.
Back in January & February while the interim CEO was speaking for Sanofi, Afrezza had decent airtime and was visible in presentations. Now its almost invisible with no plans to submit for EU approval this year and no mention on their earnings call. It's in a box next to the door, I just hope the box doesn't get pushed out the door.
I want this to be wildy successful but my confidence is shaken and I'm just trying to determine if I hold for greater things to come in 2016 or move on with modest gains after 4.5 years knowing I missed a great opportunity to sell at 10.
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Post by jpg on Aug 2, 2015 12:10:25 GMT -5
My info comes from interacting with Sanofi reps this past spring when their tuned changed and reading what others say about their interactions with Sanofi reps regarding priority vs Toujeo and coverage. Another glaring issue with Sanofi comes from Hakan and Matt saying in May (I think that was the call) that script #s are 8 weeks behind their projections. How did they get so disconnected from Sanofi's performance just 4 months into a launch? Script growth has been flat the past 8 weeks so how many months behind are script numbers now based on Mannkinds projections? I'm guessing 4 months behind now and will be interesting to see if the comment on this Monday. For those saying it's not Sanofi I completely disagree as Sanofi presents the greatest risk for me. Back in January & February while the interim CEO was speaking for Sanofi, Afrezza had decent airtime and was visible in presentations. Now its almost invisible with no plans to submit for EU approval this year and no mention on their earnings call. It's in a box next to the door, I just hope the box doesn't get pushed out the door. I want this to be wildy successful but my confidence is shaken and I'm just trying to determine if I hold for greater things to come in 2016 or move on with modest gains after 4.5 years knowing I missed a great opportunity to sell at 10. If I were you I would simply sell and move on. When you get to the stage you are at you will most likely simply pull the trigger at the next bear raid and sell for less. Confidence is everything. Once it is gone: sell. |
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Post by joeypotsandpans on Aug 2, 2015 12:14:52 GMT -5
My info comes from interacting with Sanofi reps this past spring when their tuned changed and reading what others say about their interactions with Sanofi reps regarding priority vs Toujeo and coverage. Another glaring issue with Sanofi comes from Hakan and Matt saying in May (I think that was the call) that script #s are 8 weeks behind their projections. How did they get so disconnected from Sanofi's performance just 4 months into a launch? Script growth has been flat the past 8 weeks so how many months behind are script numbers now based on Mannkinds projections? I'm guessing 4 months behind now and will be interesting to see if the comment on this Monday. For those saying it's not Sanofi I completely disagree as Sanofi presents the greatest risk for me. Back in January & February while the interim CEO was speaking for Sanofi, Afrezza had decent airtime and was visible in presentations. Now its almost invisible with no plans to submit for EU approval this year and no mention on their earnings call. It's in a box next to the door, I just hope the box doesn't get pushed out the door. I want this to be wildy successful but my confidence is shaken and I'm just trying to determine if I hold for greater things to come in 2016 or move on with modest gains after 4.5 years knowing I missed a great opportunity to sell at 10. Jimo, My last conversation (posted in other thread It's NOT sanofi) was this past Thurs., what the rep stated there is no "new drug block" makes all the sense in the world in comparing Toujeo and insurance with Afrezza and insurance. The fact that Toujeo is the same molecule and is a replacement for Lantus making it instantaneously accepted by the insurance companies is night and day with getting Afrezza past the standard "unblocked" timeline. Fortunately, we are closer to "unblocking" each day as I personally can't wait for my insurance to give the green light. My takeaway from our conversation was the person I was at lunch with when I texted the rep also can't get it right now...the rep has over two dozen patients in the same situation that they are trying to get pushed through....if you take that and conservatively extrapolate even with just 100 reps (avg of 2 per state solely representing Afrezza), that's 2400 scripts that aren't showing up in the NRx and TRx numbers...and I imagine that backlog is growing by the day. When those gates are opened, that is when the script reporting day everyone has been looking for with a big jump will happen...until then it's akin to water building behind a dam. |
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Post by mnholdem on Aug 2, 2015 18:14:23 GMT -5
Matt once told me in an email that expansion beyond 3 production lines would not happen until Sanofi begins preparation for Europe. That tells me a couple things. One, the focus is U.S. sales and, two, Sanofi's securing production rights in the distribution agreement is a safety net. Danbury will remain the primary production facility for some time. I hope that now that Afrezza has been on the market for six months, the 3rd party payers will be reviewing it. Can Sanofi present anecdotal evidence and testimonials of early adopters to persuade payers that Afrezza's a1C performance will save healthcare costs associated with hypos?
I googled that question several months ago, which took me to an FDA website where I learned the answer is "yes".
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Post by notamnkdmillionaire on Aug 2, 2015 23:06:51 GMT -5
Matt once told me in an email that expansion beyond 3 production lines would not happen until Sanofi begins preparation for Europe. That tells me a couple things. One, the focus is U.S. sales and, two, Sanofi's securing production rights in the distribution agreement is a safety net. Danbury will remain the primary production facility for some time. I hope that now that Afrezza has been on the market for six months, the 3rd party payers will be reviewing it. Can Sanofi present anecdotal evidence and testimonials of early adopters to persuade payers that Afrezza's a1C performance will save healthcare costs associated with hypos? I googled that question several months ago, which took me to an FDA website where I learned the answer is "yes". Thanks for shooting 50 caliber holes in my theory!  |
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