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Cash
May 10, 2018 13:12:37 GMT -5
Post by dreamboatcruise on May 10, 2018 13:12:37 GMT -5
Yes. Will the REMS removal and Stat study translate to more sales. If not it’ll be more dilution. The biggest impact of REMS was that the sales force had to mention it when detailing a new physician, but nothing more. I doubt it really had much of an impact on sales. STAT, due to its design, is set to deliver a positive message but it is a very small study that is not controlled and those don't change physician behavior much. Will those two items help? No doubt they will, but expect incremental improvements not hockey stick growth rates. The fact is that the company burns cash at rates that far exceed the increase in profit contribution from additional sales. They will be in cash raising mode for at least several more years. Due to the differences in pk/pd for Afrezza vs RAA, it would be nearly impossible to do a controlled blinded study that would be safe and allow optimizing outcomes for both an Afrezza arm and an RAA arm. Unless you see some way of doing that I don't. The size of the study is a valid point.
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Post by dreamboatcruise on May 10, 2018 12:56:58 GMT -5
Just because Spencer does not preach to the MNKD choir, I will take his track records over dead aim on MNKD. I'd say Spencer was spot on about the label looking back over the last 10 months. This isn't about contests between individual's and their "track records", this is about real life reality regarding people's lives. This isn't about day trader's and investments, this is about saving people's limbs, kidney's, eyes, hearts, and having a better way of life with one's family, etc. Having said that there is a 30 million share debt out there that still has to be paid, you can believe it will happen through dilution as he keeps professing, the fact is it hasn't happened yet and could have happened at close to minimal cost for almost a 100% gain. Regarding Matt's statement about the COGS, again what price is one willing to pay to extend their lives, limbs, and organs when there is a viable option that is proven to be superior, maybe not via current "labels" saddled by corrupt former administrators but by the eye test "label" when reading CGM's, etc. Sure there are those that are not fortunate enough to pay out of pocket or have coverage at this time but as the message gets out via studies like the STAT study it could help change some of the dynamics for those people as well. That is why the ignorant statement from him about the lack of effect of the STAT study is so absurd and quite frankly stupid. The "MNKD choir" are not just made up of traders and investors, it is also made up of users that take offense to those that continue to pound on a company and it's executives that are out there fighting everyday to help people. Take off your monetary glasses, it's not always about the money Dennis, Matt, Spencer, etc etc, take if from someone that is afflicted by the disease and has experienced the difference in a relatively very short period of time. Well, Spencer is about MNKD as an investment. If what you are about is all the other things you say, then ignore Spencer and rail against the insurance companies not covering it and the doctors unwilling to prescribe. Spencer certainly has nothing to do with decisions being made by PBMs and doctors. When it comes to taking investment advice from people, their track record is certainly relevant. As we've seen over the past few years... having a great insulin doesn't mean the company has been a good investment. That said I do think Spencer is a bit off the mark on STAT. It is small trial, which may blunt it's impact, but I'd side with you that it will show what is possible with Afrezza that would be more risky with RAAs and/or result in weight gain with defensive eating. With STAT Endos should realize Afrezza achieves something that it would be very tricky to pull off with RAA. Recalcitrant payers may claim it too small, etc.
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Post by dreamboatcruise on May 9, 2018 21:30:08 GMT -5
And anyone can download the adverse events data if you're interested in it.
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Post by dreamboatcruise on May 9, 2018 21:06:54 GMT -5
I'm in for 7000 shares on the dip. First time back in this in a long time. *Fingers crossed* Careful... Baba doesn't like people to cross their fingers
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Post by dreamboatcruise on May 9, 2018 21:04:47 GMT -5
China has more high income people, and China has IP protection for drugs. It's easier to command higher selling prices for imported drugs. Sadly both countries are known for copycat products. I would hope that we have adequate protection going forward there iand anywhere else the company might sell products Actually I hope that they've not patented every important aspect of manufacturing, so that some know how is kept as undisclosed trade secrets. MNKD undoubtedly has tons of experience with FDKP manufacturing that others would not have.
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Post by dreamboatcruise on May 9, 2018 20:11:15 GMT -5
agedhippie... the way they spoke about it makes it seem like this was from the "lost" (sarcasm) trials.
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Post by dreamboatcruise on May 9, 2018 20:05:24 GMT -5
Crunching numbers on the Adverse Events data reported to FDA vs prior trial data to see if they find any unexpected signals? That's likely not a full time job for many. A person can report time into different expense categories, so this doesn't mean people have necessarily stopped R&D work entirely to switch over to any one of these other areas. Yes, but towards what end? I looked back through some 10-qs and 10-ks and pharmacovigilance wasn't ever mentioned before. That part of the definition about "especially in order to identify and evaluate previously unreported adverse reactions" is bugging me. I think that would be totally expected. It may well be that this is simply tightening up their accounting. Perhaps they've really been performing those functions for some time but they're now being more precise about what category to expense their time. Perhaps. Maybe PB Matt can comment about whether this seems out of the ordinary in any way.
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Post by dreamboatcruise on May 9, 2018 19:40:28 GMT -5
Yes sounded like there was more than one more. and said maybe Q2 to be revealed... fingers crossed That's for Baba
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Post by dreamboatcruise on May 9, 2018 19:37:40 GMT -5
I don't quite get this -- "Research and development (R&D) expenses for the first quarter of 2018 were $2.6 million compared to $3.1 million for the first quarter of 2017, a decrease of $0.5 million or 16%. This decrease reflected a $1.1 million reallocation of salary and salary-related expenses from R&D in 2017 to selling, general and administrative expenses (SG&A) in 2018) associated with personnel who were engaged in R&D activities in 2017 and transitioned to providing medical affairs and pharmacovigilance support to Afrezza commercial activities in 2018." pharmacovigilance -- "the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions." Why do they need to take people out of R&D to do "pharmacovigilance"? What exactly do they do? Crunching numbers on the Adverse Events data reported to FDA vs prior trial data to see if they find any unexpected signals? That's likely not a full time job for many. A person can report time into different expense categories, so this doesn't mean people have necessarily stopped R&D work entirely to switch over to any one of these other areas.
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Post by dreamboatcruise on May 9, 2018 19:27:20 GMT -5
Mike C previously mentioned a 2nd international deal (after India) in the works. He didn't mention it this call, did he? Actually there was mention of further "term sheets" (plural) after India. If that was not a mistake, it means there is at least a 3rd (or 4th if Brazil is counted) new one in the works. I'm still suspecting that China will be the next to drop. Of course I was predicting China would be the next to drop before India, so obviously I'm guessing rather than having insider info. They're going to scientific conference in Germany... hmm?
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Post by dreamboatcruise on May 9, 2018 19:20:21 GMT -5
Person placeholder image Michael Kovacocy 6m Follow MNKD - Earnings call wrap-up...Solid progress continues towards driving a valuation based on a properly scaled Afrezza franchise along with a synergistic platform for other revenue drivers. Increased clarity on cash raise requirements along with sources of non-dilutive financing. Commentary regarding the resurrection of TV as a marketing tool driven by responsiveness and efficacy of medium are a very welcome and unexpected development. Upcoming ADA posture fulfills one of my the three catalysts for 2Q/3Q in my thesis. International expansion and Brazil 4Q/1Q go offer additional momentum catalysts above and beyond inflection in baseline US ops. Overall, I feel very comfortable following an excellent call and solid forward guidance and debrief. Stand by my targets of near-term $15 and longer term (within three years) $40. Well, right now, after hours it's down 13 cents, so the market isn't exactly jumping with joy. MK synergistic catalyzing momentum inflection gibberish not withstanding , I wouldn't judge things based on after hours. I liked what I heard/saw. No way we go to $15 near term, much less $40 long term, but I'm increasingly hopeful we may soon form a bottom on share price with sustained gains thereafter.
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Post by dreamboatcruise on May 9, 2018 17:10:51 GMT -5
Mike is expecting a lot of growth. Everything is ready. The improved hyperglycemic control, the improved hypoglycemia risk. The improved insurance coverage. The improved discussions with physicians. There's talking the talk, and then there's actually walking the walk. Somewhere in CC was mention of renewing TV commercials, yet the slides show they only expect a burn of about 100 million -- only 5 million more than 2017. That allows only 5 million more in expenditures -- will that be all they spend on TV commercials? I don't see any place they could cut costs to free up more than that. If you are correct that the projected burn is 5 million more than last year's cash burn, then you would need to also add in the increase in revenue projected for this year vs last to come up with the additional amount projected for expenditures.
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Post by dreamboatcruise on May 9, 2018 17:06:39 GMT -5
Interesting that today I got an email from an individual at the loan dept of Schwab saying the shares in the two accounts from which they had not yet taken them are not needed. This is the first time I've had them request shares and then not use them. I wonder if one of their big clients told them they might be shorting and then decided not to... perhaps related to earnings and news. Though all of that is obviously speculation with scant evidence.
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Post by dreamboatcruise on May 9, 2018 11:03:42 GMT -5
The standard for approval, almost anywhere, is that the drug must be tested on a sample of ethnic groups that approximate the intended market. There are legitimate differences with how drugs are metabolized by different groups based solely on genetic differences, thus to get a drug approved in the US based on foreign data it needs a mix of Caucasian, Hispanic, African and Asian ethnic groups or else a bridging study will be required. If necessary, the bridging trials are normally limited size Phase III trials. I would not base any estimate about India based on what happened to Generex since that company had a very dysfunctional management. The other thing to look for is whether India will require additional stability studies. It is hot in India during the summer, significantly worse than the SW United States, and humid. In parts of the country the electrical grid is prone to failure so storage requirements may be more strict than for the US. That all depends on how the regulators react. I know many are disappointed by the amount of cash received for the deal, but don't expect a lot more from China. The markets are roughly the same size and the pricing dynamics are similar, although Chinese pricing is always less transparent. Besides, now that the cash benchmarks have been established at the low end don't expect the Chinese to suddenly pay up; they are better negotiators than that. matt So which aspect of Afrezza do you think would require testing; the insulin or the Technosphere carrier? It seems to me that doing new insulin testing on different ethnic groups would be silly--insulin's properties across ethnic groups should be pretty well known by now. It also seems silly to require additional testing on Technosphere since it isn't metabolized. Am I missing something?The India climate is potentially a big plus for Afrezza once folks figure out it doesn't need to be refrigerated. Plenty of anecdotal evidence that Afrezza will do just fine without refrigeration. How do you suppose that law would be written about testing not being required if it seems silly? How many people would it need to seem silly to?
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Post by dreamboatcruise on May 8, 2018 18:53:04 GMT -5
I for one just deluded myself about what was there for all to see. Then managed to slap some sense into myself so have been making better MNKD decisions for a year or more. At this point the shorts can count on further dilution, but I think their view has been muddied by the fact that other progress just might offset the dilution anticipation and/or allow it to happen at meaningfully higher price. Of course the flip side is that most longs really aren't comfortable on betting on that hopeful outcome in a meaningful way. Hence... sideways. IMO I question why for a measly 2% one would offer their shares knowing full well the borrower's actions will most likely negatively affect the share price. At times they've paid WAY more than that. Though not believing my pittance of shares has any influence on price behavior, I would not bother loaning if I thought it would stay at 2%. I'm just wanting to have my shares in the program so that if the rate starts back up I don't miss out. Don't want to turn them down now and have them ignore me later. It has paid as much as 80%. I've made tens of thousands on loaning over the years. Really helped to cut down on my loses... and allowed me some money with which I could justify buying extra MNKD shares. I loaded up on some call options basically at the all time low this past summer using some of the interest money. So I would be in a far worse position now (with much higher break even cost) if not for loaning my shares. If someone had orders of magnitude more shares than I, then it might make a difference to share price. Or some may simply not like the idea, and that's fine, just not my thing.
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