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Post by dreamboatcruise on May 2, 2018 1:40:17 GMT -5
Kinda makes you feel that all scripts aren't reported ... SO ... need more shares!!! Well... all revenue received is reported by MNKD, and the amount reported by MNKD is, as would be expected, lower than the reported retail revenue from Symphony. So regardless as to whether Symphony's estimate is above or below the actually number of scripts... we know the revenue to MNKD is and will be significantly below the retail revenue reported by Symphony. Symphony is mostly useful for monitoring the trend... which is still growing way to slow.
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Post by dreamboatcruise on May 1, 2018 15:06:04 GMT -5
Good to see Europe, Africa and Asia included in the states for the patent filing. Yes, that would be negligent to not do that for a pharma company.
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Post by dreamboatcruise on May 1, 2018 12:24:28 GMT -5
Oops! Wrong again...
Say it ain't so, Joe! Normally I'm right simply because I check things before I post. This time I was lazy and didn't go to the patent search site. It happens, but I certainly don't condone that sort of laziness which I see all too often. I'll try harder next time In general I do give warning when I haven't verified something as with this being prefaced by stating it was a belief I had (subject to my recall)... as opposed to stating it as a hard fact.
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Post by dreamboatcruise on May 1, 2018 12:02:21 GMT -5
mnholdem... good to see. At least means they weren't in complete hibernation mode as of a year ago. If you can find me a clinical trial, I might get very excited.
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Post by dreamboatcruise on May 1, 2018 11:30:07 GMT -5
For newbies...In October of 2015 Andrea Leone-Bay left the position of Vice President of Pharmaceutical R&D at Mannkind Corporation to become the Chief Scientific Officer of RLS. It's my understanding she continues to work inside Mannkind's Danbury facility. Her name is on many MNKD patents and she has spoken at many industry conferences. While we've heard almost no public results to date, there are many reasons to believe something good is going to come from this and no reason to think she's just wasting her time on a fruitless project. It does seem time to hear a progress report. What are the many reasons to believe there is progress. I can think of only one... that MNKD included them in recent presentations. So pro... they were mentioned, but con it was mentioned without any concrete statement of progress. You mention patents but I don't believe there are any we know of from RLS. The ones listing her were from when she was still employeed at MNKD. If there really are RLS patents then that would be an indicator of progress. BTW... I know it's been speculated here on proboards that Andrea is working out of MNKD Danbury facility, but I thought that was mere speculation. Can you point to a concrete source for that?
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Post by dreamboatcruise on Apr 30, 2018 17:24:42 GMT -5
I clicked your link and saw 'unch' Was suprised it was there and I laughed. No clue what it means but I'll guess it is good. Unch. You can unch day in and day out and it doesn't add up to anything.
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Post by dreamboatcruise on Apr 30, 2018 17:18:58 GMT -5
TicToc by Bloomberg @tictoc · Apr 21 The U.S. is giving away the $30 billion medical marijuana industry. Because the feds are bogarting the weed, while Israel and Canada are grabbing market share, @joshdean66 reports #tictocnews (link: bloom.bg/2HQjQJx) bloom.bg/2HQjQJx
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Post by dreamboatcruise on Apr 30, 2018 16:18:22 GMT -5
A market cap of 2.5 billion equates to about $17 per share today. Everyone following MNKD since pre-approval knows this price would merely break even or even lose money for the company. IMO, there's no chance any BP could get TS for this amount. The possibility of a hostile takeover has now also been greatly reduced with the newly authorized shares. Management has said they're going to go it alone to build value first. I believe them. With the new hirings, forthcoming international partnerships, the STAT study and more, the idea of MNKD entertaining $10 or less is not worth discussing. This is why I remain skeptical MNKD has any current interest in being a target...unless of course a seriously attractive offer came in. Tech and biotech companies with solid science, low funds and virtually no sales have sold for more. Actually 2.5 billion market cap would equate to less than $14/share because at that price there would be a lot of low priced warrants, options and conversion rights in the money.
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Post by dreamboatcruise on Apr 30, 2018 13:54:46 GMT -5
Warning: Intended only for those with a sense of humor. I submitted your questions to investor relations and they promptly provided Mike's responses. Afrezza as Standard of care. What is the plan? Repeat the phrase often and hope investors believe it.Type one, type two. Endo, General Care physician? How do you plan to increase scripts and what do your next 12 month projections for weekly scripts look like? That's a great question and we're soliciting answers. Please call in if you have ideas. We've kept Hakan on the payroll just to answer these sorts of calls.What are your projections to break even? In other words, how long until we reach break even? Is MNKD running Afrezza commercials on television screens in physician offices? (Outcome Health for in physician's waiting room TV Advertising.) Didn't you hear that company was cooking the books. We are thinking of joining the class action suit.what does your overall advertising promotional campaign look like moving forward and what type of media mix do you plan? We plan to spread our $1,000 ad budget as broadly as possibly.What are the fixed manufacturing costs per unit, and what are the variable manufacturing costs per unit. The "unit" can be any measure they like, but one box in the new configuration is probably the most sensible. Roughly speaking, do you know how much it costs to make a Faberge egg... it's more.we are charging $.79 a unit? Really? Maybe we should raise the price, that doesn't sound like much.what is a Mannkind Cares Pharmacy and are titration packs available only at such a pharmacy? It's a pharmacy run by my wife and it brings in a little extra cash.What is the refill rate look like over the last two years and what is the projection going forward? Also what are the action items to improve refill rates? It's not good now, but we plan to start lacing the cartridges with heroin and nicotine to boost the retention rate.Even thought the estimated Primary Completion Date is July 2020, I would be interested in learning when there might be preliminary information released by the company related to the pediatric trial (ClinicalTrials.gov Identifier: NCT02527265). Might we hear something as early as Spring/Summer of 2019? We've only been in the car 15 minutes, stop asking when we'll be there.What exactly do they hope to accomplish and what results do they expect to see with the reveal of the stat study results? We hope it changes everything. Is there a difference between hope and expect... this is proboards.What is the status of the 1-2 international deals that Mike has brought up twice (1 signed term sheet, 1 soon to be signed)? Our term sheet is a very, very, very FINE term sheet with two deals in the yard
Life used to be so hard
Now everything is easy 'cause of... term sheetsWhat is being done to drive domestic sales of Afrezza? Did I mention the heroin idea?Status of pipeline, particularly Trepostinil. Is Epipen competitor dead? Epi is so flatline it couldn't be revived even with with a massive dose of adrenaline, but we're hoping investors will breath easier when we talk about Trepostinil.What specifically is being done to increase insurance coverage and what is the timetable for full coverage (eg: coverage comparable to our competitors) We project full coverage will occur long before the sun burns out.What is up with RLS and will it ever bear fruit? Obviously it must be awesome because we can't say anything about it.What ever happened to Torrey Pines and the pain patents. Why didn't this get any traction? Can I reuse the last answer?
What 60 found Afrezza studies? From? Are they published, unpublished? Will they be published? How are you planning to use them? They are being put together in a Time Life best of the 90's collectors CD edition, soon to be available at the as seen on TV website (Contempory Boogie Woogie Accordion CD free with separate handling fee).What are you thinking regarding over the counter possibilities for afrezza sales? Wow... do you think investors would really fall for that?
What were the results from the targeted DTC ads that were run in select markets and how will this information be leveraged.? We got 2 extra scripts. We'll leverage that data into the file cabinet of secrets.Do you plan on any more dilutive cap raises this year? Duh.Do sales teams/representatives visit PBM? Insurance companies? We send teams on a regular basis, but so far haven't figured out how to get past the security guard in the lobby.Can Mike and team tell us anything about the STAT results? If so what can MNKD/Mike/Team tell tells? The Univ of CO hasn't shared the results with us yet.What is the plan for STAT study result presentation? Detailed please. We plan to show up early so we can get front row seats (and cheese danishes if they have them), and are really hoping the results and presentation are good.The ADA STAT STUDY presentation to be posted on the internet? ADA won't let us do that.Is MNKD/ Afrezza making in roads into any hospital pharmacies? Definitely, but we've recently been told doctors still have to prescribe the stuff and that's proving difficult.
Many shareholders believe that the stock is grossly undervalued. What do you believe is a fair market cap valuation? We were told Al once said $100, and that was before the reverse split... so lacking any other information I'd have to go with $500.What do you think is a single and most important event / milestone fthe market is waiting for that would trigger a stock price move to that fair valuation? Having Novo and Lilly go bankrupt would be a good start.
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Post by dreamboatcruise on Apr 30, 2018 13:06:16 GMT -5
"Mike, wouldn't you agree that if we have not brought in cash through deals such that we do not need to offer more stock AND scripts are less than 1,000/wk by the end of the year, you should step down?" To me, the above is a tough, nasty question. Just asking him how he's going to get the script count up or finance the company's operations won't have much of an impact, he'll go into the same old mantra. With the question above, it has an impact, however slight, even though the answer is simple, he would launch into the answer to the easier question of how he intends to increase scripts and raise money non-dilutively. I don't think Mike will be placed into any corners, but he might be embarrassed by some questions - hopefully the attendees won't be embarrassed by the questions. He's trying hard, trying the best he knows how, got Kendall to join, I don't want to be nasty or have anyone else be nasty, I just want to try to figure if he's genuinely optimistic or not. The effort is there, and I'm not sure anyone we might get would do any better. "Well, there's a very Fine term sheet... and there's RLS... and" "LOOK!... squirrel."
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Post by dreamboatcruise on Apr 27, 2018 20:15:28 GMT -5
CEO of the yearSteve Collis - AmerisourceBergen 34% Bernard Tyson - Kaiser Permanente 3% George Barrett - Cardinal 2% Michael Castagna - MannKind Corp. 57%John Hammergren - McKesson 3% Jeff Park - Diplomat Pharmacy 2% Total votes: 2526 Last day to vote is May 2, 2018." (5:00 pm EST) Looking good for Mike C. this is because people are voting based on where the stock will be and what Mike has done not the current price per share! I thought this was all his peers in the pharmaceutical industry judging his leadership
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Post by dreamboatcruise on Apr 27, 2018 20:05:24 GMT -5
Aged, I love you. I have read, your typing that says, there were not people in the STAT trial for ........ The awful human being in me, thought, there have been studies with less people, blah blah blah. Case in point. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. In a 2-week clinical study in 18 hypercholesterolemic patients, ZETIA inhibited intestinal cholesterol absorption by 54%, compared with placebo. ZETIA had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients). www.merck.com/product/usa/pi_circulars/z/zetia/zetia_pi.pdf You absolutely can have smaller studies. An example would be a medical student in a teaching hospital who wants to perform a study. You might only have a handful of people because that's what you can scare up without money (a friend of mine researching early detection of Alzheimer's used students who he paid in whiskey). If the study proves interesting then you go looking for the money to convert it to a full trial. I think this is the model STAT-1 is looking at; get good results from the pilot and use it as leverage to get money for STAT-2, a full blown trial. You only need a large enough population to provide statistically significant outcomes, and that number varies by what you are trying to ascertain. Even the relatively large trials MNKD did in the past didn't have enough patients to have the data on "severe" hypoglycemia be statistically significant (95% probability of being causal), though logic (and human physiology) would almost dictate that if overall hypoglycemia was reduced (which was proven to the statistically significant standard) that severe hypos would also be reduced. Though I guess in medicine another issue is a population size large enough to represent the genetic diversity of the overall population. I think your researcher friend might have been invalidating his own study if he was testing for cognitive ability on a group selected for willingness to accept booze as pay
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Post by dreamboatcruise on Apr 27, 2018 19:53:28 GMT -5
You absolutely can have smaller studies. An example would be a medical student in a teaching hospital who wants to perform a study. You might only have a handful of people because that's what you can scare up without money (a friend of mine researching early detection of Alzheimer's used students who he paid in whiskey). If the study proves interesting then you go looking for the money to convert it to a full trial. I think this is the model STAT-1 is looking at; get good results from the pilot and use it as leverage to get money for STAT-2, a full blown trial. In my opinion, there is no sense in pouring money into a full blown trial for measures -- time in range, etc -- that insurers don't care about. Like it or not, insurers care about A1c and that's all they will care about for the foreseeable future. It would be so much simpler and a lot less expensive to conduct a large scale trial measuring just the change in A1c over 6 months using whatever dosing schedule Mannkind thinks would work best. Any trial should measure both. Adding a CGM to a trial protocol is comparatively small expense in running a trial. Whether the CGM should be blinded or not is separate issue. Having it blinded would be necessary to show insurance companies what could be achieved by patients that don't have access to CGM, but still useful to have the time in range data. I actually imagine FDA will be wanting to have ALL trials involve CGMs. With the new definitions of levels of hypoglycemia, a CGM would be required to properly record how many occurrences of the different levels happen.
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Post by dreamboatcruise on Apr 27, 2018 13:58:27 GMT -5
I hope you are right. Son's new endo did not have any problem with the REM or pulmonary risk (none). He only mentioned price as a concern. And that it is not covered by our plan. Still waiting for word on his efforts... meanwhile I am swinging for the next box at $600 out of pocket thanks to the coupon. But he needs closer to a box and a half to get through the month. I just paid $829.56 for ONE box of 180 cartridges (previously had incorrectly said $816). I'm in Medicare in a couple months with absolutely NO COVERAGE whatsoever. Afrezza NOT on the formulary of ANY plan Medicare Supplement Plan available in my part of the state. A box and a half will cost me about $1,200. Clever marketing Mike. Nice job. You are only excluding the biggest segment of Type 2's in the entire country (Medicare participants). Nice move. And thanks for helping diabetics. Al would be so pleased. It is a disappointment. About a year ago we were led to believe that significant Medicare coverage improvement would be coming Jan 2018. Yet, on formularylookup.com we still sit at 88% NOT covered. 18% isn't nothing, but the glass certainly isn't half full when it comes to Medicare. Too bad Afrezza (for Medicare purposes) isn't a device like CGMs. It seems because of having the insurers/PBMs in control of the formularies, the bar is much higher for drugs.
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Post by dreamboatcruise on Apr 27, 2018 12:25:20 GMT -5
I have never seen shares available to short MNKD when trading on the Fidelity platform in over three years. MNKD was not the only stock either. I was never able to locate them either via customer service. IB and Lightspeed have made shares available over the last year. it is just an observation when I was trading with them versus other brokers. In my opinion only the institutions can short MNKD at Fidelity due to policys from their risk department. The shares are available at Fidelity to short if you have the proper type of account. Generally people who are shorting a stock have tremendous asset’s pledged as they would have to pay the brokerage house back if they’re short did not work out. The short is not much different then a Vegas gambler. The house rarely loses in Vegas. The same can be said about brokerage houses. At most brokerages you just have to have a margin account and then on a daily basis they make sure the value of the assets you have in the account cover any margin balance you run. If there is shortfall you are required to put extra money in the account. If a short position is going against you, you may get a margin call every single day requiring more money. They liquidate the position if you can't keep up with the margin calls. I haven't done shorting in a long time (though have used puts as hedges), but when I first experimented with shorting in the 90's I didn't have a huge amount of assets in my brokerage account.
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