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Post by longliner on Aug 8, 2019 16:12:49 GMT -5
Yay! $15 million soon and another 15 later! Very cool! ?
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Post by ktim on Aug 8, 2019 16:14:09 GMT -5
It's not really the same, Afrezza revenue is a consistent source, revenue from partnership milestones is not. Also, TNDM is now at 63.40, MNKD is stuck at 1.10. Milestone + low single digit royalties MAY very well become a consistent source of revenue if Mike and Martine are to be believed. And we have no reason at all to believe there is any deception. So it really just boils down to probability of successful trial (highly likely IMO) and whether the results are positive enough to lock UTHR's position as dominant player vs new entrants (a bit more of unknown, though early results look positive).
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Post by prcgorman2 on Aug 8, 2019 16:17:16 GMT -5
Worth repeating. Nothing will change for a long time, unless we get a Block buster news release. Same old. same old. I agree with everything except the first sentence. And, hoping for block buster news releases would be a waste of my time.
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Post by agedhippie on Aug 8, 2019 19:06:52 GMT -5
Actually a very good comparison given it is in same market. Looking at the revenue history is informative. Before 2018, the revenue looks like slow, more or less linear growth. Then in 2018 revenue accelerates to something much that looks exponential. And the stock price bottomed and then took off beginning of 2018. Here is YoY revenue growth for TNDM. 2014 72% 2015 46% 2016 22% 2017 16% 2018 79% 2019 94% MNKD is still in a period comparable to TNDM pre 2018 where the yearly growth by percentage is dropping since the growth is basically linear rather than exponential. So perhaps this case study demonstrates that MNKD could potentially have a huge run IF the revenue crosses an inflection point and starts looking exponential. At that point they might not even need to be making a profit. Though it might be MNKD has a nice run prior to exponential growth by turning cash flow positive, or even just getting to the point where MC's assertion that no extra dilution is necessary to get there is verifiable with high degree of probability. TNDM took off because JNJ announced in 2017 that they were ending pump manufacture and would buy back their old Animas pumps. In insulin terms this is the equivalent of Lilly getting out of the insulin business. That left Omnipod, Medtronics, and Tandem as the pump manufacturers. Since a lot of the Animas users were on the Animas pump because they didn't like Medtronics or Omnipod (they would have already be on it otherwise) the beneficiary of this was Tandem which you see in the sales. Those sales could be better but Tandem's sale and customer support is swamped.
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Post by prcgorman2 on Aug 8, 2019 19:24:19 GMT -5
Actually a very good comparison given it is in same market. Looking at the revenue history is informative. Before 2018, the revenue looks like slow, more or less linear growth. Then in 2018 revenue accelerates to something much that looks exponential. And the stock price bottomed and then took off beginning of 2018. Here is YoY revenue growth for TNDM. 2014 72% 2015 46% 2016 22% 2017 16% 2018 79% 2019 94% MNKD is still in a period comparable to TNDM pre 2018 where the yearly growth by percentage is dropping since the growth is basically linear rather than exponential. So perhaps this case study demonstrates that MNKD could potentially have a huge run IF the revenue crosses an inflection point and starts looking exponential. At that point they might not even need to be making a profit. Though it might be MNKD has a nice run prior to exponential growth by turning cash flow positive, or even just getting to the point where MC's assertion that no extra dilution is necessary to get there is verifiable with high degree of probability. TNDM took off because JNJ announced in 2017 that they were ending pump manufacture and would buy back their old Animas pumps. In insulin terms this is the equivalent of Lilly getting out of the insulin business. That left Omnipod, Medtronics, and Tandem as the pump manufacturers. Since a lot of the Animas users were on the Animas pump because they didn't like Medtronics or Omnipod (they would have already be on it otherwise) the beneficiary of this was Tandem which you see in the sales. Those sales could be better but Tandem's sale and customer support is swamped. So, are you saying Mannkind needs Eli Lilly, Novo Nordisk, and Sanofi to bail on RAA insulin to enjoy a TNDM story? Or just two of the three? :-)
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Post by sweedee79 on Aug 8, 2019 19:35:31 GMT -5
The Tndm story and the Mnkd story are two different things..
Were there barriers to the Tndm pump the way there is with Afrezza? We have massive walls to penetrate..SOC.. lack of doc support.. noninferior status.. lack of awareness and knowledge of titration..
I'm not saying we can't grow sales . But it's going to be slow going.
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Post by longliner on Aug 8, 2019 19:41:49 GMT -5
The Tndm story and the Mnkd story are two different things.. Were there barriers to the Tndm pump the way there is with Afrezza? We have massive walls to penetrate..SOC.. lack of doc support.. noninferior status.. lack of awareness and knowledge of titration.. I'm not saying we can't grow sales . But it's going to be slow going. Capital, Capital, Capital.............now where have we heard this before?
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Post by sweedee79 on Aug 8, 2019 19:53:48 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo.
If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock..
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Post by longliner on Aug 8, 2019 20:11:46 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo. If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock.. No, I don't, however LLY or some other major absolutely does. It's time for a hammer, we both would enjoy watching the shorts scramble out from under that bludgeoning.
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Post by radgray68 on Aug 8, 2019 20:17:04 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo. If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock.. In the call yesterday, Mike said the India trials will be designed to better show Afrezza's attributes. He said something about the 2006 trials actually limited dose to 8 units or something like that? Then he went on to say something about the big, pre-approval, FDA guided trials, but I can't say exactly as I've only listened to it once so far. I'll listen several more times before I'm done. One curious note: Don Dupree, usually sitting in for Pasha, has been very keen to ask every quarter about the Pediatric trial commencing. That hinted to me that THAT development may be when, pardon the phrase: "shit gets real"
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Post by agedhippie on Aug 8, 2019 20:43:57 GMT -5
TNDM took off because JNJ announced in 2017 that they were ending pump manufacture and would buy back their old Animas pumps. In insulin terms this is the equivalent of Lilly getting out of the insulin business. That left Omnipod, Medtronics, and Tandem as the pump manufacturers. Since a lot of the Animas users were on the Animas pump because they didn't like Medtronics or Omnipod (they would have already be on it otherwise) the beneficiary of this was Tandem which you see in the sales. Those sales could be better but Tandem's sale and customer support is swamped. So, are you saying Mannkind needs Eli Lilly, Novo Nordisk, and Sanofi to bail on RAA insulin to enjoy a TNDM story? Or just two of the three? :-) Any one from three will do
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Post by prcgorman2 on Aug 8, 2019 20:55:34 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo. If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock.. In the call yesterday, Mike said the India trials will be designed to better show Afrezza's attributes. He said something about the 2006 trials actually limited dose to 8 units or something like that? Then he went on to say something about the big, pre-approval, FDA guided trials, but I can't say exactly as I've only listened to it once so far. I'll listen several more times before I'm done. One curious note: Don Dupree, usually sitting in for Pasha, has been very keen to ask every quarter about the Pediatric trial commencing. That hinted to me that THAT development may be when, pardon the phrase: "shit gets real" The reference to the FDA-guided pre-approval trial is a reference to the last trial required because of a letter from prison inmate Martin Shkreli (aka Pharma Bro) to the FDA which resulted in a second CRL (the first one was ridiculous too, and was based on a change from the older inhaler to the “Dreamboat” design used today). To avoid any further trials, Mannkind basically had the FDA set the conditions of the trial, which not surpising based on the corruption evident, did not prove superiority of Afrezza. When you know the history of Mannkind, it is very difficult to not be suspicious, cynical, and skeptical.
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Post by ktim on Aug 8, 2019 21:15:16 GMT -5
Actually a very good comparison given it is in same market. Looking at the revenue history is informative. Before 2018, the revenue looks like slow, more or less linear growth. Then in 2018 revenue accelerates to something much that looks exponential. And the stock price bottomed and then took off beginning of 2018. Here is YoY revenue growth for TNDM. 2014 72% 2015 46% 2016 22% 2017 16% 2018 79% 2019 94% MNKD is still in a period comparable to TNDM pre 2018 where the yearly growth by percentage is dropping since the growth is basically linear rather than exponential. So perhaps this case study demonstrates that MNKD could potentially have a huge run IF the revenue crosses an inflection point and starts looking exponential. At that point they might not even need to be making a profit. Though it might be MNKD has a nice run prior to exponential growth by turning cash flow positive, or even just getting to the point where MC's assertion that no extra dilution is necessary to get there is verifiable with high degree of probability. TNDM took off because JNJ announced in 2017 that they were ending pump manufacture and would buy back their old Animas pumps. In insulin terms this is the equivalent of Lilly getting out of the insulin business. That left Omnipod, Medtronics, and Tandem as the pump manufacturers. Since a lot of the Animas users were on the Animas pump because they didn't like Medtronics or Omnipod (they would have already be on it otherwise) the beneficiary of this was Tandem which you see in the sales. Those sales could be better but Tandem's sale and customer support is swamped. Was JNJ one of the top 2 in the market or would it be more like if SNY dropped Apidra That wouldn't be a bad suggestion for them Did most insurance cover any brand of pump a user wanted? You seem to imply that. Not disputing that but it seems surprising.
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Post by radgray68 on Aug 8, 2019 21:29:49 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo. If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock.. OH, OH, OH!!!! Just listening again to the call. KIPNES STUDY - Starting to enrol T2's this year working with Dexcom and its going to be bigger than the Phil Levin study and results presented next year. BAM!! Add to that the India trial and the Pediatric Trial, and we should have a fair chance to show superiority soon. Really excited about working with Dexcom.
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Post by prcgorman2 on Aug 8, 2019 21:57:26 GMT -5
Do you think we have the capital or the time for a large trial proving superiority? I mean Id just like to know how to solve these problems or change the status quo. If Mike could address these problems I would feel a lot more confident.. My belief is this is why we have 40mil. short on this stock.. I had the exact same question. After reading a couple of posts this week on the WTF thread, I became convinced the answer is no, Mannkind does not have the capital at this time even with $40 million added to the coffers this week. That money is to provide runway to get to break even and that is based on NOT doing a large scale, time-consuming trial to prove superiority. Stevil especially convinced me, finally (after about 3 years of thinking differently) Mannkind is not going to get around the conventional information demands of 225,000 PCPs and 4,000 Endos without the trial(s) to prove superiority. I resisted it for so long because of the absence of trying get-rich-quick marketing tactics which to me includes TV DTC. The lack of reaction in TRx after the TV DTC early this year was the final evidence I needed our problems will not be solved with better IR, websites, and advertising. Exposure is important, and I think we can all agree the medical community in general appears to be aware now, for the most part, of Afrezza. The prescribers, however, are for the most part just going to refuse to use their patients as guinea pigs. And, Afrezza doesn’t have good insurance coverage, the label is unhelpful, and it costs a premium. I am glad I’m so hard headed. If I had arrived at this same conclusion 3 years ago, I would have been so despondent I probably would have taken a huge loss and walked away bitter. (That is still a possible outcome of course). But, here we are 3Q 2019 and the little engine that could is still here, and not diluting (much) and cutting international marketing deals, and executing on pipeline deals with potential for more, many more. The path I was uninterested in, the long slow grind as MK rightly put it, is our reality. And I damn sure do not want MNKD to partner with a big BP again. Burn me once, shame on you. Burn me twice, shame on me. Besides that, I’m greedy. I want MNKD to get all of the profit. My hopes are, and I do not think them wild fantasy, UTHR’s inhalable PAH drug treprostinil in dry powder form inhaled through a Dreamboat will bring in enough royalties to Mannkind that when combined with U.S. Afrezza sales, and combined with decreased COGS from improved insulin agreement and Brazil (and India and Australia?) sales, and whatever else brings revenue in by then, will enable Mannkind to fund the trial(s) (and probably through additional, but less expensive, debt) to prove superiority. How long will all this take? My unsophisticated guess is 5 years on the current trajectory before the stock price bakes in what Mannkind is worth in possession of proven superiority and able to negotiate with the FDA on the lable, and with insurers on a more level playing field. Better stock price means better terms for equity (dilution) or debt financing to then fund full-scale marketing to get Afrezza up there with, and displacing, RAA sales. These are my hopes and what I think are reasonble expectations based on current trajectory. That trajectory can be improved. I of course hope it will be, but I will no longer look for quick-hitter solutions to make a material difference.
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