Thank you jpg for your thoughtful analysis.
In regard to the 29 million people who are already diagnosed as American diabetics, would you care to speculate on what percentage of those diabetics would switch to Afrezza? I assume they would be those who poorly manage their disease because of their difficulties associated with needle based insulin.
My guess is that 5% could be a reasonable number over the next 18 months.
Also, how many diabetics who previously refrained from using needle based insulin would now start to use Afrezza?
My guess would be that if there are 29 million diagnosed diabetics, there could be at least another 3 million who are not yet diagnosed who could be Afrezza users within the next 18 months.
I know this is pure speculation but you would have more of a sense of what could happen than most of the rest of us.
Thanks.
Hi Robsacher,
It is very easy for me to speculate but only if these pages disappear in a few years...
Short term a lot will obviously depend on the motivation/ skill of the Sanofi/ Mannkind JV which is why I was happy (relieved even) for a lower % of sale with Sanofi then another company willing to give a bigger %. Like I mentioned previously Novartis was my # 1 and Sanofi my # 2 choice. The near term marketing issue is not complicated for a company like Sanofi: this is their daily bread. They will do fine. Don't know how quickly the scripts will come in and if it will be fast enough for nervous longs but from my point of view the shorts and bears have blessed us with low expectations which was thankfully unopposed by Mannkind and Sanofi (here again I diverge significantly with some MNKD long 'management critics' (to be polite) who seem to care more about the share price in 2 days then in 2 years). I think that since partnership announcement and moving towards a 'soft launch' MNKD and Sanofi have played this very well.
To answer your questions in a non quantitative fashion I think the needle phobic pitch is as you point out much more important then investors give this market opportunity credit for. Either I see only whips in my day to day practice or there is a huge massive opportunity there. In my opinion the groups that say 'needles are so small they don't hurt anymore and the glucose monitoring is what really hurts' just don't get it. It's so much more complicated then just the acute pain of injecting. I've posted extensively on this before and will spare those who read my musings this subject again! I will simply say that those that have variations on the 'needles don't hurt' arguments are probably not big fans of medical anthropology.
Those poorly controlled on basal is another interesting group who would simply add Afrezza to their basal dosing. I already hear the 'then there will be needles group' come out in full swing saying that 'Afrezza is pointless because it doesn't get ride of needles'. This all or nothing mentality doesn't fit with the day to day reality of patients I see. Adding 3 more injections (and the complexity and risk of prandial sc injections of insulin) to a basal is a big big deal and can significantly decrease the quality of life of patients. The number of type 2 patients who go from basal alone to basal with pradial is in my estimate 1/10 of those who should make the transition. That is in itself a real and big market.
Some investors seem to think that once a drug is FDA approved studies are only done to thinker around the edges for 'label improvements'. To make this a truly revolutionary blockbuster with 'Plavix or Lipitor like sales' what I am personally really interested in seeing over the next few months are well thought out post marketing studies. Off the top of my head a few studies that could move this from a billion $ a year drug (my low sale estimate if it doesn't do as well as I think it will) to a 'very significantly above 5 billion $' a year opportunity:
-With Toujeo: Less severe hypoglycaemia, equivalent or better Hba1c and lower peaks (post prandial hypers) and valleys (hypos).
-Early type 2 diabetics: slower progression (or even regression) of diabetes with Afrezza vs oral agents. This may seem like a big deal and complicated study but if I am right this could be a much easier and faster study then the many realize (a 6 month crossover study would be one option?).
- Continuous glucose monitoring with or without Afrezza. This would be more of a trial done with one of the others mentioned here but would turn a lot of heads as we get a better understanding of the 'beat to beat' dynamics of diabetic glucose swings.
-End organ changes:longer to do obviously but in certain high risk patient groups this could be done in under 2 years. One huge group would be gestational diabetics. Afrezza would fit in perfectly with how gestational diabetics are managed in North America now (prandial insulin as first line and targeting post prandial glucose levels and NOT HbA1c). The foetus is the 'end organ damage' and as far as I am concerned one of the most powerful arguments for looking (in all patients) at post prandial glucose levels as much if not more then HbA1c.
-Mortality outcome studies with Afrezza. As for putting mortality as a primary outcome that would be a long term thing and I doubt many investors (including the companies paying for them...) will care to wait the multiple years these things take. These types of outcomes would be secondary outcomes to end organ change studies in high risk patient populations but could be surprising.
The above studies are not an exhaustive list obviously and the JV might think of better ones. I would be disappointed though if over the next 6-12 months none of these types of studies were started. Again with just a few relatively simple (and relatively cheap) studies Afrezza could go from being 'just another blockbuster' to a 'top 5 of all times blockbuster'. I know A. Mann sees this and am convinced Sanofi also sees this. Eventually the market will also see this and we will look back on these early days of the launch wondering why some ever even speculated this could be otherwise then a huge success. Kind of like the iPod, iPhone, iPad, Tesla etc...
JPG