Personally, I consider my 'expectations' quite tempered already. I think an expectation of 20% market capture is quite reasonable and realistic, and the nice thing is that this simple tempered expectation still results in MNKD likely achieving the fabled '10-Bagger' status. I can see 50% of those already adapted to the pen, as simply not being interested, at least not for the first few years following Afrezza availability. Now I think it is a different story for diabetics who are just 'progressing' to the point of needing prandial insulin...I am guessing that this group will highly favor Afrezza. I think 20% is a given, and I suspect that figure to rise to 30% within the first 3 years following Afrezza approval. Assuming global insulin use continues to increase at roughly the 12% level which has been posted previously, well in approx. 4 years time, the market has increase about 50%. So, barring some competing oral treatment which comes along, or a complete 'cure' for diabetes (as in say some amazing stem cell treatment), then Afrezza's $4 billion revenue in say 2017 (20% of a $20 billion global market) will likely increase to a $6 billion revenue stream by 2021...and that is what I call a pretty tempered and conservative expectation. I don't think it is unreasonable either, again barring some superior treatment, to consider that Afrezza could have more like 30% of a $30 billion prandial insulin market by 2021. Something superior pops up, well I expect to be invested in that also.
Most of the institutional/fund money is just simply run by very risk-averse individuals, who statistics indicate are hard pressed to even match the S&P index. I think we are up against one or two large short-hedge funds run by guys who have no problem concentrating their firepower on a narrow and select few targets. We either need to attract one or more similar type heavy hitters to oppose them with equal determination, like Icahn coming in long against Ackman in the Herbalife face-off, or else we are just going to have to wait until things like a positive FDA decision comes down on the NDA, and or a partnership surfaces; the imprimatur of BP sponsorship is everything when it comes to getting the really big risk averse money off the sidelines. I don't think it helps that Al, a few years back, pretty much proclaimed a huge share price boosting partnership was on the table and soon to be announced, and then nothing...I think there may be a credibility gap in other words. Who knows, maybe somebody knows how to contact Icahn and get him interested; imagine the effect were an Icahn position in MNKD to be publicized!
It is also possible, the way the 74-day FDA NDA acceptance procedure is now structured, that FDA has indicated this is a 'sticking' point which they wish addressed. If the trial is being run on FDA suggestion, I am wondering if this increases the likelihood that the FDA won't give the thumbs up until they get their assurances. I would hate to see further delay, but this is just the kind of thing the FDA is famous for, this kind of thing and much worse of course.
Some dufus named gino calls MNKD a ponzi scam...read the response, you have to expand the comments. That boy got some serious education at the hands of one of our own.
Good response...Global prandial insulin consumption apparently will be in the vicinity of a $20 billion dollar market by 2016 if not sooner. Likely, as with most drugs/treatments these days...the US $ market is out of proportion to the volume percentage of that global market. Very prudent to secure one's supply lines well ahead of combat initiation; Al hasn't achieved his track record by being imprudent, rash, nor careless.
As far as I know, Al & Co. aren't given to rash and/or foolish financial allocations of their rather meager resources...undertaking these studies now is almost certainly based on very prudent reasoning; my guess is there is a very very well founded and prudent reason for the timing of this effort...one obviously we mushrooms aren't privy to. Considering they supposedly are thick in the process of determining the best partner/partners to cozy up to, one could reasonably assume that the timing here is a direct reflection of some input they have received in this process...possible FDA input is involved if not something from one of the potential partners. Relax, we are in good hands with a seasoned captain at the helm; great patience is required for us longs at this point.
Excellent response. Personally, I see the move as prudent, and I an certain they have a very good reason for their efforts at this time...we just aren't privy to their motivation/motivations, as the reasons and the timing may be multiple; for all we know the FDA's input may be evident here or a potential partner may have been insistent.
One of our major holders has been accumulating, but I agree that so far we haven't seen the kind of accumulation which will serve to force the short covering we have all been expecting. Maybe the EMEA filing will serve to generate some interest...this could be coming any week now.
And of course a European partner likely is not going to be on hold for the FDA's final acceptance of the NDA, especially if Al is looking at a co-promotion deal with a BP for the US, and a separate BP deal for Europe. Who knows how the 'rest-of-world' split will be divided up. And of course there is that possibility that China or India may leapfrog them both...I mean the safety and superiority have pretty much been established conclusively (superiority when one considers the obvious increase in compliance which Afrezza will entail)...so I consider that possibility a realistic one.
They certainly have the money. Obviously they are aware that Afrezza is superior to Exhubera by design and delivery, but I also truly doubt that they will just sit by and not attempt to resurrect Exhubera with a new delivery device, possibly expediting the process in league with China. One 'benefit' in favor or partnering up with them is that eliminates such a future prospect.
I have full expectations that China will likely begin producing some equivalent of Afrezza, maybe joining with PFE to use Exhubera but with a modernized delivery device; sorry, but they steal everything they can and ignore patent law with seeming impunity. Truly hope I am wrong about this conjecture, and that we make great profits from selling Afrezza to the Chinese, but I truly doubt they will abide by any legal/patent restraints/agreements for long, if at all.
Simple...it is extremely prudent, not to mention someone at FDA likely 'hinted' it would be considered proactive to have this study in hand.
Also, it is possible that one of the BP's in contention, who happens to be a major supplier, like say whoever produced PFE's original $10 B lot, brought up the point. As in during partnership discussions, they said btw, another reason you should choose us is you don't even know if those other guys, if their insulin even works the same. It is simply prudent to think and plan ahead.
Keep in mind, that with this little nugget, we have been warned that more capital may be necessary...not like we weren't already given fair warning with the remark about likely needing a small in-house sales team for US co-promotion efforts.
I think this is wise, and it hopefully gives them the leverage to enforce a proper and 100% effort on at least the US partner...thus no foot-dragging by a BP partner conflicted about cannibalizing existing product sales.
Well, a bit more than a couple of weeks if it goes the full course. It was just common sense that the FDA would need to give the full acceptance on the NDA before anyone would actually make that commitment. Seems unlikely we here anything on partnership until the new year, as I doubt they would want such an announcement during the holidays.
Indeed, it does happen puttinhole. Remember that VW squeeze? That was rumored to have wiped out, or seriously damaged, a few on the short side. OTOH, it is such common knowledge that partnership negotiations are ongoing, so it would be unlikely that 'the pros' wouldn't be well prepared.
OT a bit, but have you experimented with the likes of cinnamon, bitter melon, etc? If I remember, you are heavy into exercise.
Yeah, I was intentionally rounding down just a bit on REGN's p/s numbers...trying to stay reasonable is all. So many moving parts in such an extrapolation, I can't see any reason to be overly optimistic. Who knows where the market is headed 2 or 3 years out, maybe we finally get a huge bear-market collapse, and all metrics are cut in half....hell, maybe the US receives a nuclear or EMP present from one of our many enemies, and there is no more market or electric grid for that matter. May sound silly to some, but I take very seriously the Book of Revelation and the 'End-Times' script laid out there. We all do this for money, but a time is coming, according to Christian Scripture, where no man will be able to buy or sell without a 'mark' on his right hand or forhead (I assume that is for those who have no right hand)....it also says if one takes that 'mark' then you are pretty much lost to God and salvation, at least that is how I read it. Sorry for the sermonette there...LOL