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Post by compound26 on Jul 18, 2018 13:59:31 GMT -5
Add $2m from India and another $2m to $3m from next term sheet (China anyone?) and voila we make guidance. Don’t recall mike staying all revenue was related to us script sales only but could be wrong. Agree. But I think it is more likely via a bulk shipment to Brazil as revenue recognition is tied to shipment of Afrezza. I think Mike can probably expect a shipment of around $5-6 million to Brazil if needed to enable Mannkind to make guidance. This is similar to what Mannkind did in terms of meeting the guidance of 2nd half of 2017. I think this is all fine as long as it is within the accounting rules. To me, the more important part is the upward trend and momentum. As long as we keep growing, we will do fine. Additionally, as sales grow and international expansion kicks in, the margin will keep improving, which will another driver for meeting the guidance. Think about it, had Mannkind management started doing what Mike and Dave are doing (STAT trials, international partnership, dusting off old trials, getting publications, fixing package, better understanding of dosing and titration, etc.) from 2015, then we would be in much better position right now. Had Mannkind management raised a couple of hundred of millions in 2014/2015, we would also in much better position. However, all in all, we are in a much better position than 2016 and 2017 at this moment.
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Post by compound26 on Jul 18, 2018 13:09:30 GMT -5
We should still be on target for Mike's guidance of $28-30M for FY18 since revs have already equaled FY17s...and should come close or beat Snakeofi's total Rx for FY15 that had a much, much larger sales force. harryx1 A picture is worth a thousand words! To put things in perspective, Dexcom first received FDA approval for its first generation CGM in 2006 and it did not earn any profit until this year (2018). It took 12 years for Dexcom to earn any profit. Mannkind received approval for Afrezza in 2014. Can Mannkind be profitable in 12 years after approval of Afrezza (i.e., by 2026)? I have full confidence Mike, Dave and the gang will beat that timeline handsomely.
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Post by compound26 on Jul 11, 2018 22:45:55 GMT -5
there are no absolutes; only spectrums which I say absolutely. He got in cheaper than I did. Lucky guy. No Trick! It's a typo or a conspiracy; yet it is. Hopefully the other "facts" are right. "the president" just got stood up to by the republican party on the trade issue. the year is 2018. It's Still July. Breath!!! www.marketwatch.com/investing/stock/nnfn/insiders?pid=121917255Dec. 21, 2017.
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Post by compound26 on Jul 3, 2018 13:56:12 GMT -5
Hey,at least Proboards Matt is no longer preparing us for bankruptcy (or telling us that the sales force is costing us $10 million a month). Yes, Proboards Matt knew for a fact that back in 2016 Mannkind's meager contract sales force cost Mannkind $10 million a month. Proboards Matt also observed that Mannkind was burning about $20 million a month in 2016 even though Mannkind was talking about a $10 million/month burning rate. Here is Matt's number crunching. mnkd.proboards.com/post/75017
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Post by compound26 on Jun 28, 2018 10:34:27 GMT -5
My "take"on the stat study has been determined in part on the actual results, which by and large seem actually pretty good, but also on what I consider to be the promise of what it has shown us and for which Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes. When the stat study first came out I was expecting more positive comments from people. I am not a true science person so I was a bit confused at what I thought was the underwhelming response to the study, espcially given a few people on this board whom I respect for their science background that did not see the merits as very positive.. But upon further study and hearing more comments it is now my personal beleif that the stat study results are quite positive and lay the groundwork for the new mannkind and the new conversation about Afrezza that goes with it. That conversation imho is as follows: 1. Stat study showed how Afrezza can accomplish exactly, if not better control, as what an RAA can accomplish in less time with less hypos. To me, this in and of itself is good news. You can debate whether or not the numbers are statiscally relevant. Does it make Afrezza superior? I beleive it does. 2. Now the promise... what the study did not do is show how Afrezza can work to keep better control and TIR at significanntly lower levels of fasting BG which would require in many cases higher does of basal insulin and/or adjusments to prandial dosing. But as we know from the many anecdotal posters on social media, they are getting non diabetic numbers in the 5's and even more of them in the low to mid 6's for Hba1c's using Afrezza by targeting lower fasting BG at anywhere from 120 to 140. So why didn't the stat study show this as a goal? because imho it could not as a first of its kind study with a comparison to RAA's as its basis, since doing so would require dosing that most docs will not do with traditional RAA insulins as it would drive pwd into more severe hypos. (The stat study targeted 160 for fasting BG.) A separate study targeting lower BG will likely have to be done under more direct management if a comparison is done or with Afrezza only. THIS is the NEW story that could not be told now without the stat study... Remember that the ADA recently raised the acceptable Hba1c level to 8 from 7 or so because it has been too hard to get pwd to the lower levels without hypos and compliance is difficult with all that it entails for a T1. Afrezza changes all of this. Just think if you can now get pwd to a range of 5.5 to 6.5 with the same or less hypos... You don't think this would have to be the new SOC? And this is what Dr. likely meant when stating that Afrezza should be the SOC. Now again I do not have diabetes and I am not a science person so someone with a better understanding may be able to correct me if I have mispoken and hope they will but what imho I beleive is the true value of the stat study is the conversation Dr. K and the reps can now have with other docs that they had no basis for prior to the stat study... After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#Based on Dr. Kendall’s presentation, here are my thoughts: 1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185. You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front. 2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves. Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “ based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media. Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level. 3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care. 4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data.
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Post by compound26 on Jun 26, 2018 13:19:44 GMT -5
The price target did move as I recall didn't Wainwirght lower the target to $2 very recently? I think that $2 target was indeed a typo. Note in today's report, it is once again, " reiterate". All the recent reports from Wainwright has been "reiterate". It does not look like there was a downgrade recently. If there was a downgrade recently, then in today's report, it would be noted that it is an upgrade.
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Post by compound26 on Jun 21, 2018 18:40:45 GMT -5
Mike C said, "doctors will be shocked at the results". Dr. Kendall says RAAs are antiquated and barbaric and that Afrezza should be the standard of care. Because of these type statements, it's my opinion that any attempts to dilute or downplay the STAT study results are not likely based on informed sound analysis. I look forward to hearing Dr. Kendall's most important interpretation and explanation. After all, it's likely the reason he left a global executive position at Lilly to join little Mannkind corporation. I was not aware Mike said that, when? I guess I missed it but I have to agree with him. Its significantly better than I was expecting and mirrors the 171 results in the non-compliant TI group which gives it huge credibility.
It seems some are missing the point this was a treat to target study and not a "change the target" study. A 33% reduction in severe hypos is huge. Lowing the target baseline for the RAAs would be rather dangerous and is reflected by the significantly higher number of hypos in the RAA <7.0 PWDs. Lowering their baseline might cause death.
However reducing the target from the 160 to 140 which appears very doable with afrezza with no significant hypo increase would not only greatly improve A1c it would also significantly improve the TIR number as most of the out of TIR was during sleeping.
I doubt current afrezza users like afrezzauser and others posting their results on social media are targeting 160 as their baseline.
A few weeks back, on the Afrezza users facebook group, there was a discussion on what level the users set their CGM for correction with Afrezza. I remember most users stated that they set it at 120, 130 or 140.
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Post by compound26 on Jun 16, 2018 17:43:13 GMT -5
If I remember correctly, Dance's formula is basically is an updated version of Exubera. One difference is that they liquefied it. The team behind Dance also worked on Exubera.
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Post by compound26 on Jun 13, 2018 17:05:58 GMT -5
That price target of $2 is most likely a typo. I am 99% sure of that. There are a few reasons. 1. First, the articles says he is reiterating a buy rating. You do not have a "buy" rating when the shares are trading at $1.93+ and you have a price target at $2. There is basically no upside, then what is the rationale for you to "buy"?
2. Second, since he is "reiterating" a buy rating, let's see what was his last rating. His last rating was issued on June 7 and the price target was $5.
www.analystratings.com/articles/analysts-offer-insights-on-healthcare-companies-miragen-therapeutics-inc-nasdaq-mgen-athersys-nasdaq-athx-and-mannkind-nasdaq-mnkd/
MannKind (NASDAQ: MNKD)
In a report released today, Oren Livnat from H.C. Wainwright maintained a Buy rating on MannKind (NASDAQ: MNKD), with a price target of $5. The company’s shares opened today at $2.03, close to its 52-week low of $1.09.
Livnat wrote:
“We believe the existing treprostinil formulations suffer from clear deficiencies with very complicated and onerous drug delivery and/or dosing-limitations which likely limit efficacy. Due in large part to these limitations, in our view, prostacyclins are only used by about 20% of the 30,000 diagnosed U.S. PAH patients despite 80% being eligible. MannKind will pursue an expedited 505(b)2 bioequivalence pathway now, and could start a pivotal Tyvaso switching study in PAH patients in 2H18. We will wait to see some data first, but theoretically, TreT could be filed by end-2019 and get some credit from the market soon. If successful, we are confident that Technosphere treprostinil, or “TreT,” could represent a material innovation in the PAH prostacyclin space, even with only switching and bioequivalence data.”
So what can I say. Sloppy editors!!! But is that intentional? Who knows. Anything can happen with respect to Mannkind.
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Post by compound26 on May 4, 2018 21:17:49 GMT -5
This is not enough for a 3-month supply. Figure 12-units per meal x 3 meals per day and do the math. This doesn't take in the corrections for sedentary days. 240+240= 480 ÷ 12 = 40-days. My misstake. This price must be for 3 boxes since it says 90 days supply. One box of this NDC costs about $320 according to Goodrx. So price-wise, it also makes sense that this is for 3 boxes. So it is 480 x 3 = 1440 units. So basically, you can have 16 units per day for 90 days, or alternatively 32 units per day for 60 days, or alternatively 48 units per day for 30 days. However, if someones needs the large doses, I assume he will get either the titration package or the 12-units packages.
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Post by compound26 on May 3, 2018 19:13:55 GMT -5
Between MNKD and DXCM, it was a good day for my portfolio. Dang Dexcom moved up by 9.50 today, now at 83.81. It's ironic that the company with the life saving drug is at a mere 1.74. Something isn't right with all this, just look at the difference between these two companies' share prices. There is not a balance here between the stock market and fundamental life essentials, something MannKind provides. There should be. I don't know what to make of it. Maybe something corrupt. Well, they have a few hundred thousand active users. We probably have a few thousands. They have a few hundred million in annual sales. We have a few million annual sales (last year 9 million something). We are not there yet. But we will be there ultimately.
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Post by compound26 on May 3, 2018 11:01:56 GMT -5
I had heard over a month and a half ago that our SAB met and was amazed about how much data we have on Afrezza. I assumed they had reviewed the 60+ “lost sea scrolls” as Baba would say. I first heard about the board shortly after the mention of these found studies and around the time of Dr. Kendall having had come on board. Heard how? From whom? Well, Mike stated that Dr. kendall had put together a scientific advisory board in his Oppenheimer presentation on March 20th (that's about one month and a half ago) and he said they would announce that shortly. Mike mentioned that at about 3 minutes into the presentation. www.veracast.com/webcasts/opco/healthcare2018/62115262045.cfm?0.626093092849I have been eagerly waiting for this announcement for a while.
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Post by compound26 on Apr 25, 2018 10:25:22 GMT -5
It definitely should be [signed] term sheet as that was what Mike stated. See my original post on this. SA's transcripts usually are just for reference. They often screw up on a few places. Sometimes in the most important places. This is one of those occasions.
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Post by compound26 on Apr 24, 2018 20:36:38 GMT -5
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Post by compound26 on Apr 20, 2018 17:47:51 GMT -5
Stuart A. Weinzimer, MD, of Yale University, explained how inhaled insulin and intra-peritoneal insulin delivered through a port could provide small priming doses of insulin for mealtime-related excursions. Dr. Weinzimer was one of the early artificial pancreas developers. He is on the Afrezza closed loop trial. Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy medicine.yale.edu/ycci/clinicaltrials/find/1450.trial
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