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Post by peppy on Nov 8, 2017 7:18:26 GMT -5
Mike mentioned they're watching how two lawsuits between a couple of the large Pharma plays out, it plays into pricing etc. and anti-competitive practices if I recall correctly, was working while I overheard it. Will look at the transcripts to get a better idea of the context it was mentioned in. It was Pat not Mike, here is the excerpt which I think is sooooo important regarding the situation with the payors, etc.: Patrick McCauley I mean I think you have seen two lawsuits, one Pfizer versus J&J and one Shire versus Allergen looking at the some of the market behaviors around access to care on different product profiles. This is something we're watching closely and studying. We've had many good discussions with the payers and we have a lot of good support out there with thought leaders as well as patient advocates. And so we know we have a slightly higher dropout rate because of the actions between the competition as well as the payer. But we also have a lot of success given our limited contracted lives. Remember we only contract for roughly 20% of all the prescriptions. And so as we go out there we get 70% to 80% coverage when we do the prior authorization works. So the doctors play for the patient, those get approved many times even though we don't contract for that business. So it makes sense for payer now with this new data to really revaluate some of those previous decisions honestly that were made three years ago under the regime of Sanofi and so very few categories reviews have happened in the last two years as there hasn't been much innovation on mealtime influence. With this label change I can tell you a few of payers are reviewing the category in Q1 and we do expect to continue that good progress there. But it's always been about these payers but we feel good about to the direction and the discussions that were going on.But it's always been about these payers.
Even nadathing couldn't be on his chosen GLP-1. he got put on the glp-1 the payor had contracted. same untoward precautions. he wanted bydureon and is now on one of these, was it Trulicity? -Bydureon (Exenatide) - taken once weekly AstraZeneca bought Amylin Pharmaceuticals. -Byetta (Exenatide) - taken twice daily Amylin Pharmaceuticals, Inc. and Eli Lilly and Company at 1-800-868-1190 and www.byetta.com (byetta does not have the black box warning the others have.) -Lyxumia (lixisenatide) - taken once daily, Sanofi -Trulicity (Dulaglutide) - taken once weekly, Eli Lilly and Company -Victoza (Liraglutide) - taken once daily, NovoNordisk
if only we had been taught how the pharmaceutical reimbursement business worked in school.
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Post by pantaloons on Nov 8, 2017 7:47:53 GMT -5
Hi all, I haven't gotten a chance to go through all of the CC, but I've got some questions, if anyone's able to clarify.
Have they elaborated how the DTC will be financed and/or how much it will cost and how long this DTC campaign will last? I also see some posters have mentioned having seen some of these commercials on major networks already. Does that mean it's already begun? If not, when can we expect it to begin?
Does the markedly increased effort in DTC mean that insurance coverage is expected to increase rapidly (at least in the regions being targeted by DTC ads)? Do you anticipate MNKD leadership will elaborate more on insurance coverage more at a later time, if it has not already been addressed in detail in the CC?
Thanks for any insight.
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Post by promann on Nov 8, 2017 7:52:19 GMT -5
Hi all, I haven't gotten a chance to go through all of the CC, but I've got some questions, if anyone's able to clarify. Have they elaborated how the DTC will be financed and/or how much it will cost and how long this DTC campaign will last? I also see some posters have mentioned having seen some of these commercials on major networks already. Does that mean it's already begun? If not, when can we expect it to begin? Does the markedly increased effort in DTC mean that insurance coverage is expected to increase rapidly (at least in the regions being targeted by DTC ads)? Do you anticipate MNKD leadership will elaborate more on insurance coverage more at a later time, if it has not already been addressed in detail in the CC? Thanks for any insight. No offense but why not just read the transcript? You will find your answers there and you will learn more taboot..
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Post by hans on Nov 8, 2017 8:17:43 GMT -5
Mike said to Jason that 98% of patients weren't aware that Afrezza even existed. A few things come to mind: 1) The non-profit charity organization that creates the Standards of Care seem to be tied up in conflicting financial interests that creates biasness and hinders the awareness of Afrezza to people with diabetes. 2) The Endo Consensus is tied up in conflicting financial interests which hinders the awareness of Afrezza to people with diabetes. 3) The AACE and the ACE are tied up in conflicting financial interests which hinders the awareness of Afrezza to people with diabetes. The 98% statistic is hugh as resulted from their DTC test market. Mike C knows this and will exploit it into massive script growth with DTC. Jason tried to corner Mike with his wacko comment about Dendreon and their failure after initiating their DTC. Mike C. responsded superbly with his comment this is about diabetes not oncology and prostate cancer and that every one in eight adults have diabetes. We now need to skip the tie up with the Endo's and promote more of the VDEX like models where they only treat diabetes and they do it with Afrezza. Schedule an appointment, walk in, get treated, done. No waiting three months. We just need more awareness of VDEX as well as more VDEX locations, like on the east coast. Maybe they can start a dial up with skype. Now that would be a way to go. A VDEX appointment through my iphone. )))))
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Post by peppy on Nov 8, 2017 8:23:59 GMT -5
Hi all, I haven't gotten a chance to go through all of the CC, but I've got some questions, if anyone's able to clarify. Have they elaborated how the DTC will be financed and/or how much it will cost and how long this DTC campaign will last? I also see some posters have mentioned having seen some of these commercials on major networks already. Does that mean it's already begun? If not, when can we expect it to begin? Does the markedly increased effort in DTC mean that insurance coverage is expected to increase rapidly (at least in the regions being targeted by DTC ads)? Do you anticipate MNKD leadership will elaborate more on insurance coverage more at a later time, if it has not already been addressed in detail in the CC? Thanks for any insight. www.screencast.com/t/g23jZpXjd
It was Pat not Mike, here is the excerpt which I think is sooooo important regarding the situation with the payors, etc.:
Patrick McCauley I mean I think you have seen two lawsuits, one Pfizer versus J&J and one Shire versus Allergen looking at the some of the market behaviors around access to care on different product profiles. This is something we're watching closely and studying. We've had many good discussions with the payers and we have a lot of good support out there with thought leaders as well as patient advocates. And so we know we have a slightly higher dropout rate because of the actions between the competition as well as the payer. But we also have a lot of success given our limited contracted lives. Remember we only contract for roughly 20% of all the prescriptions. And so as we go out there we get 70% to 80% coverage when we do the prior authorization works. So the doctors play for the patient, those get approved many times even though we don't contract for that business. So it makes sense for payer now with this new data to really revaluate some of those previous decisions honestly that were made three years ago under the regime of Sanofi and so very few categories reviews have happened in the last two years as there hasn't been much innovation on mealtime influence. With this label change I can tell you a few of payers are reviewing the category in Q1 and we do expect to continue that good progress there. But it's always been about these payers but we feel good about to the direction and the discussions that were going on.
Read more: mnkd.proboards.com/thread/9056/mnkd-confernce-call-eastern-time?page=5#ixzz4xqWbYf00
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Post by mnholdem on Nov 8, 2017 9:03:09 GMT -5
Mike mentioned they're watching how two lawsuits between a couple of the large Pharma plays out, it plays into pricing etc. and anti-competitive practices if I recall correctly, was working while I overheard it. Will look at the transcripts to get a better idea of the context it was mentioned in. It was Pat not Mike, here is the excerpt which I think is sooooo important regarding the situation with the payors, etc.: Patrick McCauley I mean I think you have seen two lawsuits, one Pfizer versus J&J and one Shire versus Allergen looking at the some of the market behaviors around access to care on different product profiles. This is something we're watching closely and studying. We've had many good discussions with the payers and we have a lot of good support out there with thought leaders as well as patient advocates. And so we know we have a slightly higher dropout rate because of the actions between the competition as well as the payer. But we also have a lot of success given our limited contracted lives. Remember we only contract for roughly 20% of all the prescriptions. And so as we go out there we get 70% to 80% coverage when we do the prior authorization works. So the doctors play for the patient, those get approved many times even though we don't contract for that business. So it makes sense for payer now with this new data to really revaluate some of those previous decisions honestly that were made three years ago under the regime of Sanofi and so very few categories reviews have happened in the last two years as there hasn't been much innovation on mealtime influence. With this label change I can tell you a few of payers are reviewing the category in Q1 and we do expect to continue that good progress there. But it's always been about these payers but we feel good about to the direction and the discussions that were going on.
Pfizer states in the lawsuit that J&J is offering discounts on its Remicade treatment in exchange for essentially excluding Pfizer’s drug from insurance coverage, keeping it out of the hands of patients.
Source: www.reuters.com/article/us-pfizer-trial-johnson-johnson/pfizer-files-suit-against-jj-over-remicade-contracts-idUSKCN1BV1S8
Doesn't it seem to you that mentioning these lawsuits indicates that MannKind management suspects the same things are happening with Afrezza? Pat sure seems to be indicating that's what they think.
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Post by agedhippie on Nov 8, 2017 9:12:39 GMT -5
I don't think it's even a question. It has been happening for years in the insulin market. Try and see how many PBMs have both Novolog, Humalog, and Apidra all at the preferred tier. All the big PBMs have negotiated deals that favor one insulin and shut out all the others.
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Post by alethea on Nov 8, 2017 9:17:17 GMT -5
I think that's spiro's cat looking for the last Mallomar, isn't it? OK, how's this? Brentie, I loved the cat video. I've had cats all my life. Everyone of them did that exact same thing. It is impossible to set down a box or paper bag that your cat won't get into. I'll guarantee that cat had extricated himself from the box within several seconds. And I'll also guarantee that cat went back for more. Please keep the wonderful cat videos coming!
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Post by liane on Nov 8, 2017 9:25:45 GMT -5
I missed the cat Avatar; I hope brentie will show it again.
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Post by brentie on Nov 8, 2017 9:43:43 GMT -5
I missed the cat Avatar; I hope brentie will show it again. For you, Liane, I'll be glad to show it again. DBC and Lefty, cover your eyes.
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Post by tlundy on Nov 8, 2017 10:18:34 GMT -5
Per the cc -- net income in Q3 2017 was $2.0M (up from $1.5M previous Q). This means to meet lower end guidance at year end of $6M NI for Q4 needs to be 4M (200% Q over Q increase). Am I missing something or is this a VERY tall order?
Binder did provide the following reasons -- including DTC TV advertising -- as to why they will make lower guidance. Hope he is right:
Mike, Pat and I are confident in reaching a low end of our revenue guidance for the second half of 2017, let me tell you why. First, Afrezza is promotionally responsive. Our sales reps now have another quarter of interactions with physicians behind them and we're further supporting this by moving marketing spend from Q1 2018 to Q4 2017 for direct to consumer TV advertising and digital marketing. Second, we expect a positive commercial impact from our label change. Third, we expect favorable pricing in mix versus Q3 of 2017. Fourth, we expect that visibility to the amount of inventory in the retail channel that will help us to further refine our recognized and deferred revenue. And lastly, our average daily shipments to wholesalers grew 26% from September to October which is reflective of increased demand being pulled through the wholesale and retail channels. Collectively these reasons enable us to feel comfortable in achieving the lower end of our revenue guidance for the second half of 2017.
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Post by traderdennis on Nov 8, 2017 10:27:45 GMT -5
Per the cc -- net income in Q3 2017 was $2.0M (up from $1.5M previous Q). This means to meet lower end guidance at year end of $6M NI for Q4 needs to be 4M (200% Q over Q increase). Am I missing something or is this a VERY tall order? Binder did provide the following reasons -- including DTC TV advertising -- as to why they will make lower guidance. Hope he is right: Mike, Pat and I are confident in reaching a low end of our revenue guidance for the second half of 2017, let me tell you why. First, Afrezza is promotionally responsive. Our sales reps now have another quarter of interactions with physicians behind them and we're further supporting this by moving marketing spend from Q1 2018 to Q4 2017 for direct to consumer TV advertising and digital marketing. Second, we expect a positive commercial impact from our label change. Third, we expect favorable pricing in mix versus Q3 of 2017. Fourth, we expect that visibility to the amount of inventory in the retail channel that will help us to further refine our recognized and deferred revenue. And lastly, our average daily shipments to wholesalers grew 26% from September to October which is reflective of increased demand being pulled through the wholesale and retail channels. Collectively these reasons enable us to feel comfortable in achieving the lower end of our revenue guidance for the second half of 2017. Mnkd needs to average about 750 scripts per week for the remainder of the quarter to make the low end of guidance. Dtc should help next but refills would not increase until q1 at best with dtc
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Post by peppy on Nov 8, 2017 10:30:49 GMT -5
Per the cc -- net income in Q3 2017 was $2.0M (up from $1.5M previous Q). This means to meet lower end guidance at year end of $6M NI for Q4 needs to be 4M (200% Q over Q increase). Am I missing something or is this a VERY tall order? Binder did provide the following reasons -- including DTC TV advertising -- as to why they will make lower guidance. Hope he is right: Mike, Pat and I are confident in reaching a low end of our revenue guidance for the second half of 2017, let me tell you why. First, Afrezza is promotionally responsive. Our sales reps now have another quarter of interactions with physicians behind them and we're further supporting this by moving marketing spend from Q1 2018 to Q4 2017 for direct to consumer TV advertising and digital marketing. Second, we expect a positive commercial impact from our label change. Third, we expect favorable pricing in mix versus Q3 of 2017. Fourth, we expect that visibility to the amount of inventory in the retail channel that will help us to further refine our recognized and deferred revenue. And lastly, our average daily shipments to wholesalers grew 26% from September to October which is reflective of increased demand being pulled through the wholesale and retail channels. Collectively these reasons enable us to feel comfortable in achieving the lower end of our revenue guidance for the second half of 2017. Mnkd needs to average about 750 scripts per week for the remainder of the quarter to make the low end of guidance. Dtc should help next but refills would not increase until q1 at best with dtc Thanks for the numbers. (Inappropriately, that only leaves us needing physicians with balls and office staff.)
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Post by peppy on Nov 8, 2017 11:34:38 GMT -5
I was disturbed by the comment by Jason about Dendreon. That, combined with the recent Cramer and Feuerstein bashings smacks of a conspiracy to destroy the stock and company. I thought we had gotten past that but I guess not. That said, I am happy about the TV campaign and increases in cartridges. As for PBMs, I would like to have heard more specifics regarding who has signed on for 2018 that were not on board in 2017 or who have improved Afrezza's accessibility with respect to classification (PA, Preferred, etc). I am disturbed by Jason. It would seem he is close to the tail end of a horse.
Jason McCarthy from Maxim. Please go ahead.
Jason McCarthy
Hi guys, I have a question about the commercial strategy that you are implementing, can you give us a sense of the timing of those commercials, meaning will they be on specific time slots like on Sunday afternoons or Saturday afternoons or at night and how do you expect that impacts sales and how do you project the cost of those commercials going forward?
Michael Castagna
Hi Jason, this is Mike. Thank you for the question. We expect it to be a mix of morning, evening, prime time, and throughout the day commercials seven days a week. So this isn't expecting, there are some options where you can just look at impressions and buy last minute advertising. These are buys on the channels that we've shown and we expect to see them throughout all hours of the day. And one thing I'll add is that these are -- we went deep in this particular market that we believe are over indexed and ready for continued success. We want to really show the tri-effect of a good sales rep with good physician support, TV and digital all going into a market. So if you just think about scale up and optionality in 2018 we can get a pretty quick read on what we need to do.
Jason McCarthy
And just a follow-up to that because we've been covering this space for a while and the last company that we covered, that did this was Dendreon and for them it was kind of the last step before the company ran into significant difficulties with their debt. I'm just curious if that's something that you guys are thinking about?
Michael Castagna
No, we have always had in our capital plan a Q1 increase in TV advertising. Given that we raised the $61 million, this was really a pull forward from 2018 because there was no reason to sit on cash and not invest it to grow. We tested this commercial extensively, really looking at the patient feedback, patient recall, patient intent, how fast it was for doctor, and in over 500 patients studied whether you are Type I, Type II, on insulin or orals there is a very high intent and desire to try our presence. So to me there is a very big difference than Dendreon which is treating in immunotherapy in cancer and prostate with a very complex system and a drug that's wide scale use and a product like Afrezza that impacts one out ten Americans. These are very different scenarios and we're just very excited to get the information out there for patients because you may or may not know the average patients spend less than 10 minutes a quarter with a doctor. That doctor is worried about running A1C test, checking their eye sight, and getting them out the door. We need patients to really be informed of healthcare choices and we saw 98% were not aware that Afrezza exist. We know we had to make this investment, it was just a matter of when and not if. --------------------------------------------------------------------------------------------------------------------------------------------------- www.smarteranalyst.com/2017/09/29/maxim-pounds-table-mannkind-corporation-mnkd/ Maxim analyst Jason Kolbert was out pounding the table on MannKind Corporation (NASDAQ:MNKD) Friday, reiterating a Buy rating and price target of $4.00, which implies an upside of 83% from current levels.
Kolbert wrote, “MannKind is heading in the right direction with a new management team, the re-launch of Afrezza, a label change coming, and a platform inhalation technology that could expand to multiple indications beyond insulin.” the analyst continued, “So what’s holding back the valuation? The bears will bang on debt drums, but do the analysis and you should see what we do…a company positioned to grow.”
Can Afrezza revenues ultimately overcome the debt? “Yeah, “IOHO” (In Our Humble Opinion) we think so but it’s going to take time (& additional capital – equity and/or debt) to drive patient adoption. Our research (interviews with diabetes patients) tells us that patient understanding of how to best utilize a rapid acting insulin, learning how to titrate dose and altering habits is a learning curve but adoption will happen. Ease of use and rapid onset are great features vs. injection (time to see levels adjust),” Kolbert added.
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Post by zuegirdor on Nov 8, 2017 12:44:31 GMT -5
Mnkd needs to average about 750 scripts per week for the remainder of the quarter to make the low end of guidance. Dtc should help next but refills would not increase until q1 at best with dtc Thanks for the numbers. (Inappropriately, that only leaves us needing physicians with balls and office staff.)
I have mostly held my tongue on pricing as a factor in the script count- partly because I have zero data on the topic. But nothing testifies like a bad experience. I have been biding my time waiting for the stock to kick up and defray our cost to cover my son's Afrezza until Kaiser gets on board. But I have been dishonest with myself and y'all about the true cost of Afrezza. We are priced out of the titration pack which allowed us to cover about 2/3 of my son's prandial insulin needs. The rest of his need we covered with humalog. But going back to the standard 90 4u + 90 8u pack we will again need to cover half his mealtime insulin needs with humalog. We told ourselves it was alright for the time being and we would make do. Well, I am now much less sanguine about that "make do" and gap between what Kaiser should do and what it will do to make things right for its Type 1 diabetic patients. Kaiser should approve a prescription of about 2100 units of Afrezza per month for my son because that is what it takes to keep his blood sugar near normal range, lower his risk for hypoglycemia and reduce the mental and emotional burden of managing his diabetes with archaic RAA insulins that 70% of patients cannot meet their target a1c's on. But we have to be realistic and intellectually honest with ourselves, especially investors. There is no way in hell that Kaiser is going to increase the cost of prandial insulin per patient from 280 to $1800 - an increase of 600%. We can talk about and speculate on the cost savings of fewer complications; but that would be an enormous undertaking fraught with all kinds of assumptions the accountants cannot reconcile. How do you reconcile the fact that every patient that dies of hypoglycemia during the transition from pediatric to adult care saves the HMO a ton of money in deferred insulin expense? Afrezza will increase survivorship and therefore the cost of diabetes care. Same with type 2's. So the idea that we get to price Afrezza higher because it lowers cost of complications has already been thought through and rejected by the HMOs, I assure you! Kaiser will not cover my son's Afrezza until it is priced comparable with RAAs. And when the RAA patents expire, Afrezza will have to be priced comparable with generics. And guess what: Afrezza scripts will not rise to save the company's bacon until it makes economic sense for the HMOs to cover it. And no I don't think there is any conflict or ideological inconsistency if one wants to play the stock market AND advocate for nationalized healthcare with drug price controls! Accordingly, I probably should add to my profile the statement that I am a god-fearing atheistic conservative socialist.
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