sounds like an md who recieved his degree from the virgin islands. no parent of any diabetic under their roof will allow their child to inhale insulin into the deep lung. a final label with a cancer warning ends all hope for the drug and company. exubera casts a large shadow and the guilt by association is there be it justified or not. as an md its strange you would praise this and like everyone else hype the "no pain" selling point. as a diabetic who has tried myriad medications/devices i can tell u (as u should know) that the newest pen injectors are basically painless and take seconds to administer. i would say the pain and speed are that of getting snapped with a weak rubberband. afrezza is a clumsy overy complicated method of insulin delivery with dosing that nobody understands yet (as the trial dropouts stated) because technosphere needs to be trial and errored to each individual using it. it barely works better than placebo (per mnkd's own trial data) and will have zero market.
A Lehman type event, a major terrorist attack, a war, or devastating natural disaster. there has to be a major event and until then this market is not going to stop going up just for the sake of stopping. dont be fools and pool all of your fundamentals and technicals together to try and shoehorn a bear case. it doesnt matter one iota. yes, an event will eventually come of course but betting on when is a fools errand.
you cannot just say "insulin does not cause cancer" when you say insulin what you mean is insulin hypodermically injected. technosphere is a relatively new molecular carry device and attching it to insulin and having it inhaled into the deep lung has no longterm safety data (and i dont mean a measily 5 years of data). my point is ive lost faith in the company beacuse i believe they are incredibly fically irresponsible which is surprising. al mann is 84 which past the statistical age of death and any health issue that comes up could clobber this company. the share offering this fall couls sink this 25% quickly.
close doesnt count. 2000 is a hard number not some imaginary line in the sand. the real danger for bears is the amount of shorting going on. not with options either. thats the fuel for the next move up and i will say that if there is a break above 2000 it could be a very violent move up indeed leavng 2000 in the dust. the longer we stay up here the more likely the break above 2000 and we have been up here a while already.
mnkd built out a manufacturing infrastructure because they knew finding a favorable partnership deal would be nearly impossible and might hazard bringing afrezza to market by themselves. their debt issues and cash burn right now are staggering and i would expect a share offering in 1-3 months. the fda labeling is not finished and i posit that the label will kill off all prospective diabetics except the niche group who have a serious and diagnosed needle phobia. afrezza looks to have little to offer and if the huge dropout rate in the trials and their reasoning are any indication nobody would touch this. guilt by association with exubera will never leave and no pharma or their insurers want to risk a cancer class action no matter how small the possibility. either no partner or the deal will be awful. im buying 2016 $3 leaps puts and assume a bankruptcy filing will be a going concern by then.
c'mon, if for no other reason than for hedgies and mm's to say "told ya so". maybe even a brief single digit vix so they can say "told ya so" as well. fundamentals and technicals are irrelevant, they have been for years since the fed's fraud. why would the market go down now? whats so special about now? nothing. ultimately the hardest thing about riding a bull is staying on. i wouldnt be short until sept oct.
Bankruptcy. There is almost no doubt in my mind anymore that this is ultimately where mnkd will be in 2016 or earlier.
What's playing out with mnkd is a slow motion train wreck with multiple war front losses piling up in the boxcars.
This is a haunting problem that has not gone away and won't. Multiple share offerings, a CEO setting up his own "offsite" financing wing, creditor obligations aplenty, a tapped and soon to be tapped out credit facility. All of this manifested by mnkd's reckless and incredible $25M+ quarterly cash burn rate that again, shows no signs of abatement. It's unsustainable and without a prodigious up front partnership payout the clock is ticking quickly.
Front 2. Partnership
I don't believe there will be one. Exubera casts a large shadow and wether it's fair or not fair "guilt by association" is something Afrezza will have to contend with and has. With mnkd controlling wholly the manufacturing of technosphere and a jingoistic defense of its formulation they go into partnership deals expecting something very lucrative. And that's fine because quite honestly, with their mounting debt issues and cash burn they NEED one. Nothing short of a very lucrative deal would save mnkd and even that would delay the inevitable. This is precisely why I believe there will be NO partnership for mnkd and their pride will have them march on alone with Afrezza in marketing, sales and everything else. This won't work at all.
Front 3. Zero retreat
There is zero pipeline at mnkd. Nothing relevant and the irrelevant that they have is a decade from reaching an NDA. There's zero value in the company without Afrezza. They have nothing to retreat to because they are fighting backs against an empty cliff.
Front 4. FDA
This final labeling is a battle with the FDA who have been reluctant for years to approve Afrezza to begin with. Finally mnkd forced their way to a panel which the FDA ...contin below
i have a limit order set at $7.9. I do surrender to the fact that we likely wont dip there without a general market correction which would slam the daylights out of the biotech sector overall. in my analysis its the only quasi support level area i can find with mnkd and in biotechs i like to use the option strangle displacement method to find potential supports/profit points. The technicals are a mess here, and i would expect some volatility until the stock can work itself out. The multiple rounds of dilution over the years along with the multiple crl's and fda action dates messed this chart up so it resembles a globular protein. as you all are a ware i sold my entire position late June and -have been : will be- patient waiting for a potential re-entry.
stock has held up
lots of attention
fda approved product
heavy cash burn rate
gen market potential pullback
increasing short attack/positioning
bubble biotech sector
considerable competition lofty valuation
the negatives win with ease for now but i expect alot of those ills to be cured with a more favorable price point for potential investors. i believe that to be the $7's which is what I will be patiently and placidly awaiting with hundreds of thousand$ in dry powder.
Sentiment: Strong Sell
Bbara1, there's no room for emotions in trading. Mnkd has a fine product which I believe will do quite well eventually but much can go wrong. "an earth shaking partnership"? I've traded biotechs for a decade and have seen some dandy partnership deals that did nothing for the stock and in some cases sent prices reeling temporarily. If you are in this for the long haul (2-5 years) that's great, I just would not go expecting any real price movements for some time.
To the poster below- al Mann will not sell this company while he is living and that should sit fine with shareholders because no other pharma would ever consider buying mnkd for $20 a share. This company right now has some huge debt problems and far too high cash burn rate-thus the need for a partner sooner rather than later
In fact I see a dead in the water situation here where a range between $8-$11sticks until late next year with full product launch. The only players who I'll make anything are the day traders, hft bots, option traders, and swing traders. A partnership announcement will bring with it heavy volume with zero net price movement. My strategy here will be monthly iron condors which will be cheap and profitable as iv has collapsed and the otm puts/calls have favorable premiums.
People still holding out for some big move (both longs and shorts alike) are in for an unfortunate surprise.
Nobody cares. You don't I don't nobody does. This country will be a Hispanic wonderland soon enough and I don't care about their babies.
???????????? What? We've been "selling off"? So why are we at 197 which is near the all time historical high? We have hardly moved. Looks like an imminent s&p 2000 test to me.
There wont be a buyout when taking into consideration the debt load and current mkt cap. 4B+debt+bringing afrezza to mkt? Not going to happen.
There wont be a buyout when taking into consideration the debt load and current mkt cap. 4B+debt+bringing afrezza to mkt? Not going to happen.
The good is that the product was approved with good labeling. The label is not harsh at all imho and is as good as could be expected. Much better than exubera's was (dosing in units certainly helped).
The bad is that this will be a very difficult product to partner with for big pharma. Questions remain around target market. Do they believe they can target pediatrics and effectively market to children? Im not so sure about that. Geriatrics? Im not sure that group would ditch their pens or the endos would prescribe contingent on their current prescription loads. Granted this leaves the biggest market of all still open but questions remain around pre-prescription screening. Too, questions remain around dosing unfortunately. A partner will come of course but how favorable will it be. Will the upfront cash payment be enough to truncate dilution? Ive said for years my biggest problem with mnkd has always been their cash burn rate which is way too high for a company with no real pipeline. What % of sales will the company receive for Afrezza? Clearly the company wants a large % because they have built out massive factories for technosphere production. We will see.
The ugly is the general market. A pullback in the general market will clobber everything especially small caps and mnkd is no exception especially now that it has reached a pps that allows funds to buy.
Conclusion- i sold two weeks ago as authored in my Y! Mb post. I have little thought of buying again unless we dip below $8. I also need to know the parnership details as well. Dilution based on that will make or break this stock for 1-2 years imho.
As the only documented individual on this board who has made hundreds of thousands on mnkd (see my video by searching "mnkd 200,000") i would say $7.5 is in the cards with a general mkt pullback of 10%-15%. If not then a $8-$10 range is likely. Holding out for a partnership can be as much risk as reward. The partnership without enough up front cash to stop the cash burn or solid % sales model could send this down hard. A favorable partnership could send this $12-$15 in time. I sold on june 24th. I believe the lions share of the money here has been made. Sorry.
I truly want this medication approved. But instead of authoring and angry and bigoted post try an educated and informative one. Tell is why you are holding and why the a pps spike is going to come to fruition. Corroborate your thoughts with examples, experiences and sound logic as i have.
If you hold through this i would like to know why next time will be any different. If you have this type of risk habit already why will it suddenly change after mnkd? If this is the way it is with you then it doesnt matter wether mnkd rockets or burns because eventually you lose everything anyway. You need to develop discipline and there is no place more important for that the biotech sector which kills off a good 99% of its participants precisely because of what you are not doing- taking profits. There will always be a hundred more opportunities in the markets. Walk away.
Peacefully while there is time. The FDA is fanatically risk-averse and has not improved one bit under Margret Hamburg. The only drugs seeing swift approvals belong to fortune 500 pharma companies and are not so much novel drug candidates as they are improvements of current offerings.
Anyone follow the MenB vaccine FDA delays this year? Quite literally with several documented cases people are dying while the FDA continues to delay the vaccine while university after university continues to independently validate the vaccines efficacy. Meningitis is a disease with an unmet need and no approved drugs/therapy. Its gotten to the point where a senator has taken up the cause and may try to pressure the FDA into action.
My point of bringing this up is that a drug who's underlying disease effects more than 300M people globally with an already met need will be under considerable scrutiny. The drug in question is Afrezza and the underlying disease diabetes. What many need to realize is that an Adcom vote of "no" means "no". An Adcom vote of "yes" means "maybe". I have been trading biotech since 2001 and it took me years to learn this. Im going to give you an Adcom statistic that will strike some rational into the present euphoria- The FDA votes against positive Adcom panels 50% of the time. Thats not a typo. 50%. I was victim of one myself. Ever heard of Ezogabine? Well it was GlaxoSmithKline's lead drug candidate that received a 13-0 Adcom yes vote. FDA issued a CRL and I lost thousands of dollars with an option spread i had. What was even more disturbing was that the FDA cited "non-clinical" reasons for the CRL and we never found out what they were because investors are not privy to those documents. I have colleagues that got clobbered on several other companies with runaway positive Adcom's- orex, itmn, dndn etc... I put little faith in Adcom effects on the FDA decisions because they have "coin flip" type odds.
The above was the first part of the problem. The second part is mnkd's price action. Approval is expected. Look at the current mnkd option board for contracts dated past July 15. Calls outweigh Puts nearly 2:1 at most strikes. That is exactly what you DO NOT want to see when going into one of these catalysts expecting a pps pop. The beta has also collapsed over the last month. This tells me that an approval is not only expected but the price movement up will not only be very small but very short lived as well. This of course if there even is a pps pop. The straddle/strangle pair is basically worthless unless you are the one selling the pair.
Short squeezes in biotech are usually grossly overrated events most of the time. By the time an action date ends the volume is astronomical and the infamous "days to cover" took a matter of hours. Add that to the fact mnkd is nearing 400M outstanding shares and its easy to see that a short squeeze is irrelevant. Short squeezes are really only relevant in stocks that have low floats or that pay dividends or that have myriad longterm (5 years+) investors (institutional or otherwise) or a combination.
Many many things can go wrong here. Another delay of 3+ months, and unfavorable label for any indication, a CRL, or as i have seen dozens of times-nothing. Yes nothing. The date comes and goes and we hear nothing from the FDA or company. Weeks go by before we hear that either the company received info and did not disclose it or the FDA needs more time. In the former case a perpetual string of class actions start hitting the newswires before the company addresses the situation. I have seen this happen more times than you might feel comfortable hearing about. However, i do not see mnkd as this type of company. Lastly, there is the situation where there is an approval and the stock sinks. In fact i would be remiss if i did not say I have seen this the majority of the time when approvals are expected.
Conclusion- i believe the lions share of the money for 2014 in mnkd has been made. I do think the odds for approval are good and a trading range between $7-$10 thereafter likely but this is the biotech sector so always expect the unexpected. If i was still long sitting on huge profits i would walk away, enjoy the profit and be patient. A position in mnkd heretoforward is nothing but wreckless speculation for anyone already sitting on profits.