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Post by dreamboatcruise on Aug 7, 2015 12:08:59 GMT -5
Reviewing what Compound said and the data on Formularylookup, Afrezza is only has preferred insurance status of 4% vs. Toujeo's 28%. Toujeo vs. Afrezza overall on Formularylookup on 08.07.2015. Insurance Status Toujeo Afrezza Preferred 28% 4% Covered 23% 21% Restricted 28% 43% Not Covered 22% 32% And I've been tracking these numbers for about 4 months now and they aren't changing. The covered goes up a tiny bit at times... but interesting goes down as well. Maybe it's just noise in the data collection. Overall it really is the same over this time period. I will feel a LOT better if once these numbers start improving.
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Post by joeypotsandpans on Aug 7, 2015 12:15:08 GMT -5
Reviewing what Compound said and the data on Formularylookup, Afrezza is only has preferred insurance status of 4% vs. Toujeo's 28%. Toujeo vs. Afrezza overall on Formularylookup on 08.07.2015. Insurance Status Toujeo Afrezza Preferred 28% 4% Covered 23% 21% Restricted 28% 43% Not Covered 22% 32% And I've been tracking these numbers for about 4 months now and they aren't changing. The covered goes up a tiny bit at times... but interesting goes down as well. Maybe it's just noise in the data collection. Overall it really is the same over this time period. I will feel a LOT better if once these numbers start improving.And, more importantly so will countless diabetics too feel a lot better and live longer, healthier lives
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Post by dreamboatcruise on Aug 7, 2015 12:18:04 GMT -5
I am of the opinion that the price Sanofi has set for Afrezza was set intentionally high in preparation for these negotiations and that comments made by MNKD management at numerous 2014-2015 conferences that Afrezza will be competitively-priced against popular RAA prandials was forward-speaking about where Afrezza pricing will fall in after initial Sanofi-Payer negotiations are done. We'll see in this 2nd half - or should we all be using Matt's phrase of "stay tuned"? Well stated. You first have to test the market on pricing as you know that Insurance companies will work hard to get your pricing reduced. Sanofi / MannKind know that they have to be competitive with branded insulin or they won't sell the product. This is just a positioning of getting into the formulary and than negotiating a better deal. The insurance companies want the best outcome to keep the patient in good health, out of the hospital, and with minimal or progressive complications that cost them $$$ in future treatment. Afrezza will be a drug that will help keep their patients compliant and with less progressive complications. We just have to be patient. Payers wanting to keep people out of the hospital, yes... as for progression, sadly I don't think the insurers are as concerned about that. One, all companies have short term financial views. Second, patients switch from one insurer to another all the time. An insurer that bears the burden of a more expensive treatment now may not even reap any benefit of slowing/halting progression if the patient is covered by someone else by the time those complications would cost money. I've discussed this with a friend that is in healthcare financial management and he pretty much agrees. If medical associations change their guidelines that would put strong pressure on payers to cover a treatment with long term benefit, but they are unlikely to take the long view proactively. Hopefully the short view advantages of Afrezza are compelling enough.
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Post by seanismorris on Aug 7, 2015 12:53:51 GMT -5
It seems clear the problem is not just what patients pay for Afrezza but what insurance companies also pay. Until both approach price parity with competing products we won't have the jump in scripts we are all waiting for.
Sanofi needs to get with the program, stop worrying about margins, and start negotiating. There is no point spending heavily on marketing until they get this fixed.
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Post by mssciguy on Aug 7, 2015 13:00:03 GMT -5
Sanofi has Aphidra. It will lose patent protection in 2018
There is a conflict of interest here with Sanofi.
Will take time for uptake, not a big priority with them apparently, very slow rollout
I'll tell ya, as someone with some formulation experience, why not have a product with both long-acting AND short-acting insulins, so that the "NO NEEDLES" would truly apply?
I know, FDA is a huge bureaucracy and the head of FDA is married to a hedge fund guy, but maybe float the idea to doctors and see what kind of support there is.
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Post by compound26 on Aug 7, 2015 13:47:53 GMT -5
Here is a comment by Greg Johnstone, who recently wrote the "MannKind's Afrezza: One Investor's User Experience, Practical Insights And Perspective Of A Diabetic Pharmacologist" article. (http://seekingalpha.com/article/3390555-mannkinds-afrezza-one-investors-user-experience-practical-insights-and-perspective-of-a-diabetic-pharmacologist) Greg Johnstone in replying to a comment by Duago: "The cost, even after adding on the US$ to CD$ exchange was quite comparable, to my surprise. I paid for it without an expectation of reimbursement, as I wanted to try it and gain some experience and insight. I would not want to continue using it by paying out of my pocket without reimbursement. That is why I am waiting for access to Afrezza in a way that my health plan will cover it." Aug 7, 2015. 12:54 PM seekingalpha.com/author/greg-johnstone/commentsSo very similar comment to Rozale's comment regarding pricing (and insurance coverage) of Afrezza.
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Post by compound26 on Aug 7, 2015 14:42:02 GMT -5
Here are comments from LeMarJackson to the article: MannKind's Afrezza: One Investor's User Experience, Practical Insights And Perspective Of A Diabetic Pharmacologist [http://seekingalpha.com/article/3390555-mannkinds-afrezza-one-investors-user-experience-practical-insights-and-perspective-of-a-diabetic-pharmacologist]
LeMarJackson: Thanks for your write up. It added to my decision to continue holding MNKD. BTW my doctor had also never heard of Afrezza when I sought to learn how it was doing in his practice. And no one had ever contacted him to provide samples etc. In his opinion, insurance companies are the deciding factor for any new drug's success because most patients simply will not pay out of pocket if there is a cheaper alternative. He seemed pretty happy with the status quo, meaning no hassle in him getting paid, the patient is happy the insurance company covers insulin, and the insurance company approves. MNKD really needs to work on this.
Aug 7, 2015. 12:20 PM
Every general practitioner must have some diabetic patients. I was surprised when he said no salespeople had ever approached him and he had never heard about it. That shows poor marketing IMO.
Aug 7, 2015. 01:15 PM
My contact was last week. Am in a major city where I would hope they would target as important to build momentum.
Aug 7, 2015. 01:57 PM
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Post by dreamboatcruise on Aug 7, 2015 16:14:07 GMT -5
I wish one of the analysts on CC would directly ask about formulary and pricing. Something along the lines of... "Before the partnership with Sanofi, MNKD stated that Afrezza would be priced comparable to pen RAAs. It now appears that Afrezza is at a premium to traditional RAAs, and formulary acceptance to date is poor. Is this a long term strategy to command a higher price based on Afrezza's unique clinical benefits, and if so, how will MNKD avoid more dilutive financing through the slow process of Afrezza being accepted by payers as superior?"
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Post by mssciguy on Aug 7, 2015 16:23:04 GMT -5
I wish one of the analysts on CC would directly ask about formulary and pricing. Something along the lines of... "Before the partnership with Sanofi, MNKD stated that Afrezza would be priced comparable to pen RAAs. It now appears that Afrezza is at a premium to traditional RAAs, and formulary acceptance to date is poor. Is this a long term strategy to command a higher price based on Afrezza's unique clinical benefits, and if so, how will MNKD avoid more dilutive financing through the slow process of Afrezza being accepted by payers as superior?" so true, "Life can only be understood in retrospect but must be lived forward" Some theories on other boards that Sanofi has placed the price higher, to allow for negotiating to lower prices with insurers when demand spikes, and superiority is demonstrated. I doubt that that the actual cost of production is very much. Huge margins in pharma, too much, so let's face it, it's probably overpriced now, and the price will drop with volume. There was a very ridiculous news article a couple days ago comparing Afrezza to ridiculously priced cancer drugs--- some copy and paste gone thoughtless... but, it's true, price it right (eventually) and you will take out ALL of the competition... If you know Peter Thiel, that is what he professes, you need to be a MONOPOLY. Hmmmm French name and Sanofi is French, I wonder....
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Post by mannmade on Aug 7, 2015 16:41:04 GMT -5
I agree the margins in pharma are high but we tend to forget the need to recoup R&D costs not just on the drugs that make it to market but especially those that do not. Otherwise there is no incentive to take risk and innovation will be seriously impeded. Is there a better solution to this than we currently have, yes I believe there is but not in the current environment.
For one, I would allow for patent extensions conditional on pricing and distribution to the 3rd world. This would also eliminate the generics and maybe even help curb some of the imitation (knockoff) drugs that make it to market and actually help ensure QC. Just my 2 cents...
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Post by joeypotsandpans on Aug 7, 2015 17:14:06 GMT -5
Sanofi has Aphidra. It will lose patent protection in 2018 There is a conflict of interest here with Sanofi. Will take time for uptake, not a big priority with them apparently, very slow rollout I'll tell ya, as someone with some formulation experience, why not have a product with both long-acting AND short-acting insulins, so that the "NO NEEDLES" would truly apply? I know, FDA is a huge bureaucracy and the head of FDA is married to a hedge fund guy, but maybe float the idea to doctors and see what kind of support there is. should read and the FORMER head of FDA....she bailed/stepped down www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html?_r=0this is the quote that I think she should ask the diabetics or their families over that 6 yr. period which just so happens to coincidentally run congruent with the hassles/obstacles/pushback/DELAYS,etc,etc that the FDA gave Al and MNKD: “ Six years in this job is really a lot,” she said. “When I took over, it was often described as an agency in crisis. I’ve been able to turn that around, to really improve morale and change the culture of the agency in some important ways. I hope that I’ve really made it a stronger and better place.” www.clipartbest.com/cliparts/Kin/gd7/Kingd7zrT.gifI guess 8-10 yrs for a vastly superior insulin is then an eternity, right?
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Post by mssciguy on Aug 7, 2015 17:54:13 GMT -5
Sanofi has Aphidra. It will lose patent protection in 2018 There is a conflict of interest here with Sanofi. Will take time for uptake, not a big priority with them apparently, very slow rollout I'll tell ya, as someone with some formulation experience, why not have a product with both long-acting AND short-acting insulins, so that the "NO NEEDLES" would truly apply? I know, FDA is a huge bureaucracy and the head of FDA is married to a hedge fund guy, but maybe float the idea to doctors and see what kind of support there is. should read and the FORMER head of FDA....she bailed/stepped down www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html?_r=0this is the quote that I think she should ask the diabetics or their families over that 6 yr. period which just so happens to coincidentally run congruent with the hassles/obstacles/pushback/DELAYS,etc,etc that the FDA gave Al and MNKD: “ Six years in this job is really a lot,” she said. “When I took over, it was often described as an agency in crisis. I’ve been able to turn that around, to really improve morale and change the culture of the agency in some important ways. I hope that I’ve really made it a stronger and better place.” I guess 8-10 yrs for a vastly superior insulin is then an eternity, right? Great article, thank you. But, you know, some positions in the Fed Govt require that everything happens at light speed. I like her, just not any hedge fund people having any influence in govt. And that, my friends, is a total pipe dream at this time.
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Post by robsacher on Aug 7, 2015 20:27:31 GMT -5
Kbrion, I think the Shorts know that the drug will prevail and they are playing this game of pushing and bashing the stock because they can. I truly believe that this will end and when it does it will be worth all this pain. But why continue this astronomical short float when there are so many catalysts that could cripple them? All over a small biotech company?!?!?! Pre Afrezza licensing and FDA approval the games though ridiculously manipulated were probably an easy money maker, but now all it would take would be 1 catalyst that could crush them. I've done my due diligence and am comfortable with my investment in MNKD but I just can't get their current angle. They are much smarter individuals than myself but I mean am I giving them too much credit? The pessimistic side of me still says they have inside knowledge on a slow Sanofi strategy for Afrezza or a major roadblock like not being able to obtain the desired Insurance coverage. kbrion77, I think I can answer your question. First, it pays for shorts to continuing shorting because they know that they have an overwhelming supply of available shares loaned to them by longs who are willing to loan out their shares for shorting in return for double digit interest rates, rates that sometimes can reach as high as 60%. Remember, no shares can be shorted without a long deciding to lend them. Second, absent any really powerful positive or negative events, MannKind is and will continue to be in the hands of traders who profit by pumping the stock up and then sell at the top. They then drive the price per share down and buy shares again at the bottom. They do this over and over again. If you look at a chart of the last two years, you'll see that MNKD was bought at around $5 and sold at $6 six consecutive times. Those numbers may change for the time being, perhaps trading between $3.75 and $4.75 until a decent positive news event, i.e.. EU approval, but no event will likely be able to sustain a rally. Likewise, no trader will want to see the p/s lowered so much that they catastrophically drive down the volume. Hence, we get a trading range. Traders know that only one thing can break a continuos cycle of pumping and dumping and that is a dynamic change in the current paradigm. In the case of MannKind, that change would have to be success in the market place, or, at least enough success to be able to demonstrate that the "likely" success of Afrezza will soon be at hand. Catalysts, while positive, are not intrinsic game changers. Not even FDA approval or partnership with Sanofi were powerful enough positive catalysts to prevent the return of a shorting thesis. The only positive catalyst powerful enough to be responsible for a sustained and permanent end, or large diminishment, of shorted shares will be strong sales of Afrezza. I believe that Afrezza is a game changer and that the inhaled insulin will replace injection insulin. But, that's a mighty large paradigm shift to be initiating in a powerfully old paradigm. In particular, here are the pillars of that paradigm: 1. Insulin is a multi billion dollar industry and the two powerful companies that control that industry will not simply go quietly into the night. And, they have a war chest of billions of dollars that they can use on behalf of their cause, i.e. FDA "designed" clinical trials that won't allow Afrezza to be shown as a superior insulin, money for hedge funds that will short on their behalf with an eye towards keeping MannKind from becoming a darling child of Wall Street, and money for continuous mass promotion and marketing of their own products. 2. Endocrinologists have been trained in a procedure and method for more than thirty years. Does anyone really think that they are going to abandon what they know overnight? Seriously. It's not going to happen, especially without that needed FDA endorsement of Afrezza as a being superior to injection insulin. The early adopters may know best but their reports are not based on clinical studies. Therefore, most doctors will not find early adopter's findings compelling enough to outweigh the inertia in which those doctors wallow. In short, we need a new study from Sanofi that will show Afrezza as a superior insulin. That being written, there are, and will continue to be, doctors who learn about Afrezza, and through social media, more and more of those doctor's patients will want to try Afrezza. The best doctor's will figure out for which of their patients Afrezza will work best. Eventually, those first patients will let their doctors know that Afrezza is truly superior, come clinical trial or study or nothing. The results will make themselves clear. But, again, this success will take at least a year to begin and another year to establish itself. 3. Insurance companies are not immediately allowing new drugs to enter their system as Tier 2 category medications. It will likely take a year, or so, to get Afrezza into Tier 2. Therfore, again, sales will be slow until that happens. 4. This last foundation is about the diabetic community, itself. I'm possibly being most speculative on this point but it could be possible that a great number of T1s are simply used to injections and will not find a need to change. I saw a number of those sentiments written in various diabetes forums when Afrezza first entered the market last february. However, I think this may be an example of old dogs not wanting to learn new tricks. Perhaps, younger members of the diabetic community may be more open minded and interested in change. In regard to T2s, well, that population is huge, over 90% of the entire diabetic landscape. I'm sure less than 1% of that population have heard of Afrezza, so far. It will take a large, sustained, and successful Sanofi promotion and advertising campaign, at least running for a couple of years, before a significant percentage of the T2 population understand the value Afrezza will bring into their lives. Sorry for the length of my reply. But, I hope that I have been helpful. Best wishes, RS PS: Having written the above statement, I still believe that MNKD will likely trade closer to $10 than $5, YTD, and that today is a wonderful time to add shares to one's position. If I am correct about next years p/s then shares bought today could return over a 100% return by this date, next year.
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Post by notamnkdmillionaire on Aug 7, 2015 20:36:32 GMT -5
kbrion77, I think I can answer your question. First, it pays for shorts to continuing shorting because they know that they have an overwhelming supply of available shares loaned to them by longs who are willing to loan out their shares for shorting in return for double digit interest rates, rates that sometimes can reach as high as 60%. Remember, no shares can be shorted without a long deciding to lend them. Rob, are you sure that all the stock that is lent out is from longs who give the okay to lend them out? If you own margined shares, I believe a firm can be lend them out without informing you. Firms that own shares themselves can lend them out (hence why many have securities lending departments).
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Post by robsacher on Aug 7, 2015 20:49:41 GMT -5
kbrion77, I think I can answer your question. First, it pays for shorts to continuing shorting because they know that they have an overwhelming supply of available shares loaned to them by longs who are willing to loan out their shares for shorting in return for double digit interest rates, rates that sometimes can reach as high as 60%. Remember, no shares can be shorted without a long deciding to lend them. Rob, are you sure that all the stock that is lent out is from longs who give the okay to lend them out? If you own margined shares, I believe a firm can be lend them out without informing you. Firms that own shares themselves can lend them out (hence why many have securities lending departments). You're absolutely right. But, MNKD cannot be bought on margin at most brokerage houses, I believe. At least, it's been that way at the broker I have used for about two years. But even so, the brokerage house is often simply a middle man in that they find customers (shorts) to whom they provide those shares to be shorted in return for collecting the interest. But, you are correct, anyone with a margin account is allowing their shares to be shorted, even if they have not bought MNKD shares on margin.
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