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Post by peppy on Jun 10, 2015 5:51:45 GMT -5
Full Report: Jefferies Reiterates Bullish View on MNKD Following Positive ADA Physician FeedBack. 2u being Developed .
Jefferies Reiterates Bullish View on MannKind (MNKD) Following Positive Physician Feedback From ADA
June 9, 2015 8:23 AM
Jefferies analyst Shaunak Deepak reiterated his Buy rating and $9 price target on MannKind (NASDAQ: MNKD) following positive physician feedback from the American Diabetes Association (ADA).
"At the ADA meeting we spoke to 20 U.S. physicians who were familiar with Afrezza and found that while only six had prescribed the drug to date, only one of physicians was fundamentally concerned about prescribing it," Deepak commented. "The one physician who expressed caution about prescribing Afrezza said that he remained worried about delivery of insulin, a hormone, into the lung. As a reminder, our survey last month suggested an eventual range of 8-12% of physicians unwilling to prescribe Afrezza (see 5/15 Note). Of the remaining 13 physicians, we spoke to two pediatric endocrinologists who said they were not going to prescribe the drug until the FDA approved Afrezza for use in children. However, both were positive about the eventual opportunity, with one claiming that he would take Afrezza himself if he were diabetic. Three physicians we spoke to worked for the VA/DOD and each expressed concerns with their ability get access to Afrezza, with one hoping for a broad government contract and another asserting it would never be put on formulary. Five physicians cited Afrezza’s cost or the need for prior authorization as a primary reason for not yet prescribing the drug to their patients. Three physicians were reluctant to try Afrezza until they had identified the ideal patient in need of insulin intensification. We see the physician openness to prescribe Afrezza as a positive that could be realized as MNKD and Sanofi’s increase efforts and discourse with payors and begin direct to consumer advertisement in early 3Q."
On feedback from the prescribing physicians, the analyst commented: "We spoke with 6 physicians who had prescribed Afrezza to 1-12 patients each. Physicians varied in their reasons for starting patients on Afrezza: from needle phobia and injection-site burden to improving control of snacking and post-prandial glucose. For most prescribers, their experience with Afrezza was too limited to offer much patient feedback, however, the prescriber who had written 12 patients scripts noted that 2 had discontinued, one for cough and one for compliance, but that the other feedback was positive. We note that two of the prescribers had purchased spirometers, due to the initial requirement for lung function testing, and that one did not perform initial lung function testing in the two patients he started. It is our understanding that MNKD and Sanofi are working on programs to ease the burden of spirometry and note there were pamphlets at ADA specifically dedicated to putting lung function testing into perspective. We look forward to further physician outreach and marketing efforts in the coming quarters."
Deepak said a 2-unit cartridge could broaden adoption. "We were somewhat surprised that five physicians independently expressed concern with their limited ability to adjust the Afrezza dose to suit their patients needs. As a reminder, Afrezza is currently available as 4- and 8-unit cartridges and a 12-unit cartridge was recently approved. One physician who had prescribed Afrezza identified the limited dose titration as a big issue, since Afrezza can be dosed at 4 or 8 units, but not 6. Another prescriber commented that Afrezza was a limited product due to the limited dosing precision. One physician who had not yet prescribed Afrezza commented that the available doses were probably okay for Type 2 diabetics, but that it would be a better drug for Type 1 diabetics when a 2-unit cartridge is available, as it would allow more precise dosing. Similarly, an endocrinologist noted that the drug is better suited for bigger people in whom titration would be less of an issue. We expect MNKD to develop a 2-unit cartridge in conjunction with their pediatric development plan for Afrezza. We believe that the availability of the 2-unit cartridge should resolve concerns around dose-titration and further expand the population of patients that physicians would consider treating with Afrezza." From the YMB
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Post by ezrasfund on Jun 10, 2015 6:42:59 GMT -5
The 2 unit dose is a big issue for doctors and patients until they unlearn their ideas about insulin/carb ratios. These ideas are an important tool for using sub-cutaneous insulin, but they do not really reflect the way that the pancreas delivers insulin to the body.
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Post by jpg on Jun 10, 2015 9:23:14 GMT -5
The 2 unit dose is a big issue for doctors and patients until they unlearn their ideas about insulin/carb ratios. These ideas are an important tool for using sub-cutaneous insulin, but they do not really reflect the way that the pancreas delivers insulin to the body. Hopefully Sanofi and MNKD will listen to numerous patients and MDs and move quickly to bring to market a 2 unit dose.
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Post by cybergym66 on Jun 10, 2015 9:28:56 GMT -5
The 2 unit dose is a big issue for doctors and patients until they unlearn their ideas about insulin/carb ratios. These ideas are an important tool for using sub-cutaneous insulin, but they do not really reflect the way that the pancreas delivers insulin to the body. Hopefully Sanofi and MNKD will listen to numerous patients and MDs and move quickly to bring to market a 2 unit dose. I don't think the 2U dose will be marketed any time soon. They are focused on the the 12U which is needed for T2s which is a bigger market.
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Post by peppy on Jun 10, 2015 9:35:02 GMT -5
Sanofi wants Afrezza on the prefeered list..hmmm
Agenda - Ohio Department of Medicaid Ohio (.gov) › medicaid › ProviderTypes 19 hours ago - Aubagio. Genzyme. 9:50. Belsomra. Merck. 9:55. Afrezza. Sanofi. 10:00. Levemir. Novo Nordisk. 10:05
From YMB
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Post by Deleted on Jun 10, 2015 9:39:38 GMT -5
Sanofi wants Afrezza on the prefeered list..hmmm Agenda - Ohio Department of Medicaid Ohio (.gov) › medicaid › ProviderTypes 19 hours ago - Aubagio. Genzyme. 9:50. Belsomra. Merck. 9:55. Afrezza. Sanofi. 10:00. Levemir. Novo Nordisk. 10:05 From YMB No offense, but we've seen most of the stuff you're pasting from YMB in various threads. Do a search before you post if you're unsure.
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Post by Deleted on Jun 10, 2015 9:43:06 GMT -5
Hopefully Sanofi and MNKD will listen to numerous patients and MDs and move quickly to bring to market a 2 unit dose. I don't think the 2U dose will be marketed any time soon. They are focused on the the 12U which is needed for T2s which is a bigger market. If you look at perceived need among docs / patients for a 2u vs the actual need, the latter is what, maybe 30% or so because of the 70% that think they need a 2u, what they might need is better understanding as to how Afrezza works and many of these docs will understand this much better within the next year. Who keeps an eye on Rx demand and decides when to add lines 4,5 & 6?
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Post by brentie on Jun 10, 2015 9:53:01 GMT -5
Hopefully Sanofi and MNKD will listen to numerous patients and MDs and move quickly to bring to market a 2 unit dose. I don't think the 2U dose will be marketed any time soon. They are focused on the the 12U which is needed for T2s which is a bigger market. "Deepak said a 2-unit cartridge could broaden adoption. "We were somewhat surprised that five physicians independently expressed concern with their limited ability to adjust the Afrezza dose to suit their patients needs. As a reminder, Afrezza is currently available as 4- and 8-unit cartridges and a 12-unit cartridge was recently approved. One physician who had prescribed Afrezza identified the limited dose titration as a big issue, since Afrezza can be dosed at 4 or 8 units, but not 6. Another prescriber commented that Afrezza was a limited product due to the limited dosing precision. One physician who had not yet prescribed Afrezza commented that the available doses were probably okay for Type 2 diabetics, but that it would be a better drug for Type 1 diabetics when a 2-unit cartridge is available, as it would allow more precise dosing. Similarly, an endocrinologist noted that the drug is better suited for bigger people in whom titration would be less of an issue. We expect MNKD to develop a 2-unit cartridge in conjunction with their pediatric development plan for Afrezza. We believe that the availability of the 2-unit cartridge should resolve concerns around dose-titration and further expand the population of patients that physicians would consider treating with Afrezza." www.streetinsider.com/Analyst+Comments/Jefferies+Reiterates+Bullish+View+on+MannKind+%28MNKD%29+Following+Positive+Physician+Feedback+From+ADA/10635961.html
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Post by jpg on Jun 10, 2015 10:38:37 GMT -5
I don't think the 2U dose will be marketed any time soon. They are focused on the the 12U which is needed for T2s which is a bigger market. If you look at perceived need among docs / patients for a 2u vs the actual need, the latter is what, maybe 30% or so because of the 70% that think they need a 2u, what they might need is better understanding as to how Afrezza works and many of these docs will understand this much better within the next year. Who keeps an eye on Rx demand and decides when to add lines 4,5 & 6? If many experts (patients and clinicians: and I consider myself an armchair clinical expert of this new drug) say 2 units are needed hopefully Sanofi will listen. The evidence so far is very clear that a 2 unit dose is needed for a non negligable segment of our 'anchor patients': type 1s. If managements say otherwise I would be truly nervous. Are you both saying you know (contrary to the Jeffries report about 2 unit dosing) that managements are not interested in 2unit dosing?
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Post by Deleted on Jun 10, 2015 10:50:19 GMT -5
If you look at perceived need among docs / patients for a 2u vs the actual need, the latter is what, maybe 30% or so because of the 70% that think they need a 2u, what they might need is better understanding as to how Afrezza works and many of these docs will understand this much better within the next year. Who keeps an eye on Rx demand and decides when to add lines 4,5 & 6? If many experts (patients and clinicians: and I consider myself an armchair clinical expert of this new drug) say 2 units are needed hopefully Sanofi will listen. The evidence so far is very clear that a 2 unit dose is needed for a non negligable segment of our 'anchor patients': type 1s. If managements say otherwise I would be truly nervous. Are you both saying you know (contrary to the Jeffries report about 2 unit dosing) that managements are not interested in 2unit dosing? I have no idea what management is or is not interested in. My point was that while many say there is a need for a 2u, when you take this group as a whole professing the "need" and have a conversation with them, the portion of the original group that truly needs a 2u will likely be a lot smaller. Jeffries does a lot of great research, but when it comes to things like this, a bit of experience in the weeds vs the forest helps to better understand the situation. My guess is no 2u with only 3 production lines up. What does it cost for a production line all in (equipment, shipping, installation and certification)?
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Post by brentie on Jun 10, 2015 10:50:27 GMT -5
If you look at perceived need among docs / patients for a 2u vs the actual need, the latter is what, maybe 30% or so because of the 70% that think they need a 2u, what they might need is better understanding as to how Afrezza works and many of these docs will understand this much better within the next year. Who keeps an eye on Rx demand and decides when to add lines 4,5 & 6? If many experts (patients and clinicians: and I consider myself an armchair clinical expert of this new drug) say 2 units are needed hopefully Sanofi will listen. The evidence so far is very clear that a 2 unit dose is needed for a non negligable segment of our 'anchor patients': type 1s. If managements say otherwise I would be truly nervous. Are you both saying you know (contrary to the Jeffries report about 2 unit dosing) that managements are not interested in 2unit dosing? jpg, it sounds like, as of a month ago, they are leaning towards pediatric use but they are looking into it for Type I's. Unidentified Analyst Okay, great. And then just last one, I was curious would your path to market be – if you want to go it is like a slightly different cartridge strength so like, if you got to look at two unit cartridge how would you end up getting that Al. Alfred Mann - Executive Chairman Well basically then, firstly we would have to be – we would have a competition that can do that, which I think going down insight is certainly not an issue and currently I mean we would certainly look at usage, it may become a relevant question when we get into the pediatric population where you maybe benefited from a lower dose unit. So, it is on the horizon, it has been discussed, but currently that is all of that project. Matthew Pfeffer - Chief Financial Officer Obviously such a thing will require FDA approval, much like the 12 units did, but it is not a complicated process and it is not hard to do it what is necessary and apply. At the point of launch we frankly hadn’t seen any. We anticipated it might be useful in the pediatric space that Hakan talked about. We have seen in the – the popular press people are saying that it might be useful in the Type 1 population as well and we are investing in that.
seekingalpha.com/article/3161476-mannkinds-mnkd-ceo-hakan-edstrom-on-q1-2015-results-earnings-call-transcript?find=unit&all=false
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Post by liane on Jun 10, 2015 10:58:53 GMT -5
scotta,
One of my take-aways from the plant tour is that it is very easy for them to change over the dosage that is being manufactured at any time. So they do not need an additional line just to manufacture a different dose.
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Post by cybergym66 on Jun 10, 2015 11:02:23 GMT -5
I don't think the 2U dose will be marketed any time soon. They are focused on the the 12U which is needed for T2s which is a bigger market. "Deepak said a 2-unit cartridge could broaden adoption. "We were somewhat surprised that five physicians independently expressed concern with their limited ability to adjust the Afrezza dose to suit their patients needs. As a reminder, Afrezza is currently available as 4- and 8-unit cartridges and a 12-unit cartridge was recently approved. One physician who had prescribed Afrezza identified the limited dose titration as a big issue, since Afrezza can be dosed at 4 or 8 units, but not 6. Another prescriber commented that Afrezza was a limited product due to the limited dosing precision. One physician who had not yet prescribed Afrezza commented that the available doses were probably okay for Type 2 diabetics, but that it would be a better drug for Type 1 diabetics when a 2-unit cartridge is available, as it would allow more precise dosing. Similarly, an endocrinologist noted that the drug is better suited for bigger people in whom titration would be less of an issue. We expect MNKD to develop a 2-unit cartridge in conjunction with their pediatric development plan for Afrezza. We believe that the availability of the 2-unit cartridge should resolve concerns around dose-titration and further expand the population of patients that physicians would consider treating with Afrezza." www.streetinsider.com/Analyst+Comments/Jefferies+Reiterates+Bullish+View+on+MannKind+%28MNKD%29+Following+Positive+Physician+Feedback+From+ADA/10635961.htmlSo what's the time frame for the Pediatric Development plan? If those plans also require further trials and studies then the 2U won't be available this year. Which is why I believe the 12U will be available much sooner than the 2U. Just from a sales point of view I think there's many more sales from the 12U vs 2U if you consider the T1 vs T2 market.
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Post by Deleted on Jun 10, 2015 11:09:53 GMT -5
scotta, One of my take-aways from the plant tour is that it is very easy for them to change over the dosage that is being manufactured at any time. So they do not need an additional line just to manufacture a different dose. Thanks Liane I recall that too. It did not sound like it would take much time / effort to switch over as I think it was some type of dye that controls material flow and quantity. As demand increases there would be less slack time in the production schedule to switch from 4,8,12 but for now, all OK just not sure for how long.
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Post by scottiemac on Jun 10, 2015 12:29:18 GMT -5
The 12u will be out in a few months. BUT they are starting pediatric clinical trials in Q3 so a 2u cartridge will probably be useful for kids and could be in production maybe next year (a guess on my part)?
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