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Post by agedhippie on Apr 28, 2016 14:32:28 GMT -5
Since Canadian pricing is apparently typically the median of the major European countries you are competing with Humalog where a box of 5 x 3ml KwikPen costs the NHS £29.46 or $47.13. Matching a box of 90 x 4u Afrezza would use 2 pens (6 x 3 x 30)/300 making $18.85. I have added an extra 2u per shot to account for priming. There are no rebate programs with the NHS, the price is the price. The European countries are all on-line since they share pricing information so it's hard for a pharma to vary the price. The CBC article notes that "drug companies are no longer being transparent about prices. Companies now typically maintain a standard price for a drug across all territories, according to Morgan, then quietly arrange rebates or discounts with each country's regulator. The result? A regulator like the PMPRB will base a drug's maximum price on its listed price in France, Germany and elsewhere, but will have no idea how much money those countries might have been rebated in an undisclosed deal with the drug company." My reading of this is that the on-line info you mention would not reflect these undisclosed rebates. That price is from MIMS so it is accurate, there are no rebates in the UK whatever the CBC article says. I checked the numbers with a friend on an NHS Area Prescribing Committee and they confirmed them. Everything is a pass-through without mark-up. Although NICE may approve a drug for the NHS only the Area Prescribing Committees can say if it can be used in their region (see postcode lottery).
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Post by mnkdfann on Apr 28, 2016 14:43:50 GMT -5
The CBC article notes that "drug companies are no longer being transparent about prices. Companies now typically maintain a standard price for a drug across all territories, according to Morgan, then quietly arrange rebates or discounts with each country's regulator. The result? A regulator like the PMPRB will base a drug's maximum price on its listed price in France, Germany and elsewhere, but will have no idea how much money those countries might have been rebated in an undisclosed deal with the drug company." My reading of this is that the on-line info you mention would not reflect these undisclosed rebates. That price is from MIMS so it is accurate, there are no rebates in the UK whatever the CBC article says. I checked the numbers with a friend on an NHS Area Prescribing Committee and they confirmed them. Everything is a pass-through without mark-up. Although NICE may approve a drug for the NHS only the Area Prescribing Committees can say if it can be used in their region (see postcode lottery). I'm not 100% sure that you or I or your friend are necessarily talking about the same thing. I was talking about rebates to the government. I do not work in the medical field, so perhaps I am confused by some of your terminology. A quick google search shows that rebates from industry to the NHS do occur in the U.K., no matter what your friend says: www.ft.com/cms/s/0/6c34f7de-a966-11e5-843e-626928909745.htmlwww.pharmafile.com/news/194319/uk-pharma-pays-out-150m-drug-rebateswww.fiercepharma.com/pharma/janssen-agrees-to-rebate-cost-of-olysio-to-england-s-nhs-if-it-doesn-t-work
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Post by seanismorris on Apr 28, 2016 15:36:32 GMT -5
Well this is interesting...but all I learned is health care systems and drug pricing is broken everywhere around the world.
No wonder MannKind wanted Sanofi to 'deal with it'.
There needs to be some kind of universal 'Price +' model with depreciation to recover the initial investment.
Education with regards to dosing seems to be a big issue with Afrezza (no idea why -seems simple) so even though Afrezza is available in a county that doesn't mean sales will be significant. It might even be detrimental to MannKinds reputation if they don't have a proper sales support in place...
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Post by sluggobear on Apr 28, 2016 16:02:15 GMT -5
I am glad to see the conversation has continued to revert back to pricing and volume. Unless RLS is about to drop a hammer and announce that dose-regulated THC/CBD will be hitting the market with near term revenues and milestones for MNKD - management must be worried that this launch 2.0 is going to be too little to late?? I am worried - isn't anyone else worried? The TRx numbers need to be in the thousands very soon. I have proposed here (and to Dr. Castagna) that Mannkind be TRULY disruptive to the WW insulin market and offer Afrezza for a very cut-rate price for at least 6 months - 1 year. Price it so low that patients won't even need insurance coverage. Thus they won't need Prior Authorization or need to jump through any other hoops. Yes I know: "what about revenues?" If they don't get TRx in the 10,000/wk range SOON - revenues won't matter anyway. This is not Oxycontin. But if Mannkind can get a hundred thousand American Type 1's "hooked" on Afrezza so that they realize the long term benefits of "freedom" and better BG ranges...then there is a future for Afrezza getting traction in the broader insulin market. Going the niche route at this point doesn't look like a viable plan and the market seems to be agreeing...
And as far as other countries, everything will help. US drug prices in general will always be far higher than EU or Asia or anywhere else, except maybe rich Arab states. Afrezza is very volume-sensitive as Matt said and that seems very believable. It's probably true that drug companies sell at cost, or minimal profit, in a lot of non-US countries. The US is where they make their money back on new drugs (and old drugs a la Shkreli).
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Post by victoria on Apr 28, 2016 16:38:49 GMT -5
Im not speaking as an expert here but as I understand it the NHS in the different countries making up the UK negotiates with drug suppliers to get the best price since they are spending taxpayers money. That would typically mean a lower price in return for access to what is a very large healthcare system in the UK, so the pharma company loses on price but gains greatly in volume. Very few people have, or feel they need, health insurance in the UK so the negotiating power of the NHS over price is undiluted.
Thats probably partly why nhs healthcare is less expensive than private healhcare on the whole, if in my view also sometimes rather inefficient and a bit "no frills" when it comes to non treatment aspects. (Coincidentally the competition offered by the nhs with the private insurers in the uk seems also to ensure reasonable value if you do use private insurance, since insurers have to offer a product which is not so expensive that people just say they'll save their money and not bother).
Matt did say afrezza cost scales down significantly with volume. Also in a state healthcare system such as the nhs the money they are prepared to pay and whether they take the drug at all is not solely cost based in terms of direct cost, it is also based on the value of the drug in terms of quality of life (quality adjusted life years) which in turn relates to things like fewer lost limbs etc. Being a semi monolithic system it does mean it can take a long view and does not have an insurance contract renewal cycle. I speak as a non fan of the nhs in fact, unusually for most people in the uk, but I think the above is probably fair to it.
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Post by matt on Apr 28, 2016 16:53:21 GMT -5
management must be worried that this launch 2.0 is going to be too little to late?? I am worried - isn't anyone else worried? The only person who is not worried is Alfred E. Newman, but I think there needs to be more clarity on cash position and cash burn before shareholders start freaking out. I suspect that the price dive this morning around 11:00 was the start of the ATM activity, maybe just a dipping of a toe in the water to see how the market would react to a lot of shares hitting at once. Whether it was ATM activity or something else, it shows that price support at serious volume is very thin. If it was the ATM we will know that when the 10-Q is published and, if it was, we will know that the company used the ATM because they couldn't find an investment bank to do a private placement at a reasonable price. Use of the ATM should be in the "Subsequent Events" footnote, but if not we can compare the shares outstanding shown on the March 31 balance sheet and the shares outstanding on the first page of the 10-Q which must be accurate within four days. If there is more than a nominal difference in shares then it was the ATM, and if the company used the ATM to raise cash that is a signal that the dilution will be punitive when it comes. Even so, punitive dilution is still better than the alternative.
Your idea to seriously drop the price is tempting, but the company does need to raise money. Showing product volume increases when you are practically giving away the drug is not how you encourage skeptical investors to take a position in your company; they are going to want hard financial results. The other problem is that dropping prices is easy but raising them later is much more difficult than you can imagine, because that is when managed care will push back. Sanofi was not totally crazy going to market at a premium price because they knew they could always drop it to increase volume if the demand was there, but maybe the 30% premium was a bit too aggressive.
Long-term, the marketing plan makes sense, and if the market still won't accept the drug then it was doomed as a commercial product from the start. The concern has to be having enough cash to last the short and medium terms.
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Post by dreamboatcruise on Apr 28, 2016 18:03:51 GMT -5
I am glad to see the conversation has continued to revert back to pricing and volume. Unless RLS is about to drop a hammer and announce that dose-regulated THC/CBD will be hitting the market with near term revenues and milestones for MNKD - management must be worried that this launch 2.0 is going to be too little to late?? I am worried - isn't anyone else worried? The TRx numbers need to be in the thousands very soon. I have proposed here (and to Dr. Castagna) that Mannkind be TRULY disruptive to the WW insulin market and offer Afrezza for a very cut-rate price for at least 6 months - 1 year. Price it so low that patients won't even need insurance coverage. Thus they won't need Prior Authorization or need to jump through any other hoops. Yes I know: "what about revenues?" If they don't get TRx in the 10,000/wk range SOON - revenues won't matter anyway. This is not Oxycontin. But if Mannkind can get a hundred thousand American Type 1's "hooked" on Afrezza so that they realize the long term benefits of "freedom" and better BG ranges...then there is a future for Afrezza getting traction in the broader insulin market. Going the niche route at this point doesn't look like a viable plan and the market seems to be agreeing... And as far as other countries, everything will help. US drug prices in general will always be far higher than EU or Asia or anywhere else, except maybe rich Arab states. Afrezza is very volume-sensitive as Matt said and that seems very believable. It's probably true that drug companies sell at cost, or minimal profit, in a lot of non-US countries. The US is where they make their money back on new drugs (and old drugs a la Shkreli). We've been told to expect first RLS milestone late in 2016. Who isn't worried? Lack of fretting isn't lack of concern. Anyone not worried about the financial situation should be hoovering up shares like crazy and I doubt many are.
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Post by sweedee79 on Apr 28, 2016 18:06:29 GMT -5
Aged you know a lot about this subject. You know MNKD can not hit $19 a box. A vial of apidra, I remember reading, with discount card the best the person could do is 100 dollars.
From a website: I live in Georgetown, Guyana. I have been getting my supplies of insulin from the Shopper's Drug Mart in Canada for the last 12 years.
I have been paying $35-$40 per vial of Apidra.
I am currently in vacation in Florida, and ran out of insulin, so I had to get a prescription to get one here.
To my surprise, the cost of one of the exact same vials here is $235.99.
How is that even possible.. does anyone know why it's so much over here? -----------------------------------------------------------------------------------------------------
How is it the pen is so much cheaper for fast acting? MNKD, Afrezza could get by on $100 dollar 30 day 4 unit cartridges I think.
I recall reading the best this person could do in the USA for apidra with discount card was over $100 dollar, like $125 for a vial. A 30 day supply.
I know Mannkind cannot hit $19 a box at the moment. It just seems that a lot of people are clinging to the idea that foreign markets, and Europe is often mentioned, is going to save them and it really isn't. The problem with most of the world is that there are national health systems so they can leverage market scale to reduce price. Tresiba just got withdrawn from Germany because the German health system refused to meet their price. To Germany this is not a problem because they have Lantus/Toujeo, Levemir, soon biosimilars all of who will meet their price. In the UK the NHS is now buying the new cancer drugs on a no cure no pay basis and the pharmas are going with it because they cannot afford to lose a market that size. The health system in the US is a trainwreck. We pay stupid prices because the largest buyer, the US government in the form of the VA or Medicare, is not allowed to negotiate. This allows the pharmas to jack up prices without penalty and the PBMs don't really care because for the most part they pass through the cost to the insurers and since you have to have insurance it lands on you in the end. Sorry, but this is a rant of mine.... The US health system is a trainwreck for sure... its capitalism . and it makes me furious.. It is taxing our economy .. people pay out so much in health care costs that there isn't much left for anything else.. its robbery IMO .. And our health care isn't that geared toward preventative medicine either .. so basically companies are making a lot of money off of sick people .. Most of our clinics and hospitals are now large and corporate as well.
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Post by bioexec25 on Apr 28, 2016 18:28:21 GMT -5
Sweedee, yes and totally agree. It is an f'd up mess of professionals and politicians. Establishment control reaches deep. As we keep turning over stones, we are finding it reaches into most every aspect of our lives and then some.
Anyone really think our Feds and Wall St. co's are not in collusion with big pharma and our health care infrastructure? Anyone think they give a rats a%% about people with diabetes versus the overall control of power? Come on everyone. Heck both party elites ready to support each other rather than have an outsider march into to Washington.
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Post by sweedee79 on Apr 28, 2016 20:15:53 GMT -5
Sweedee, yes and totally agree. It is an f'd up mess of professionals and politicians. Establishment control reaches deep. As we keep turning over stones, we are finding it reaches into most every aspect of our lives and then some. Anyone really think our Feds and Wall St. co's are not in collusion with big pharma and our health care infrastructure? Anyone think they give a rats a%% about people with diabetes versus the overall control of power? Come on everyone. Heck both party elites ready to support each other rather than have an outsider march into to Washington. What better way to make money than on something that people have to have... they have us by the b@lls and there is nothing we can do about it .. I pay out 600$ a month in insurance just for me .. and then its an HMO with a huge deductible.. so I end up having to pay out for any medical expenses as well. If I didn't have insurance I would be fearful that if something happened to me I would lose everything...
Its been in the past 20 years that there has been a large swing towards more corporate health care. It didn't used to be that way and coincidentally the costs have skyrocketed as well. Its big big business. But now I think we are off topic.. lol But yes, I totally agree with you.. and find it sad.. We've come a long way from docs who used to do home visits and got paid with chickens... People used to care a lot more than they do now... sorry to say that now its more about the money.. our entire society seems to be heading in that selfish materialistic direction.. but I guess it is what it is..
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Post by anderson on Apr 28, 2016 21:17:09 GMT -5
management must be worried that this launch 2.0 is going to be too little to late?? I am worried - isn't anyone else worried? The only person who is not worried is Alfred E. Newman, but I think there needs to be more clarity on cash position and cash burn before shareholders start freaking out. I suspect that the price dive this morning around 11:00 was the start of the ATM activity, maybe just a dipping of a toe in the water to see how the market would react to a lot of shares hitting at once. Whether it was ATM activity or something else, it shows that price support at serious volume is very thin. If it was the ATM we will know that when the 10-Q is published and, if it was, we will know that the company used the ATM because they couldn't find an investment bank to do a private placement at a reasonable price. Use of the ATM should be in the "Subsequent Events" footnote, but if not we can compare the shares outstanding shown on the March 31 balance sheet and the shares outstanding on the first page of the 10-Q which must be accurate within four days. If there is more than a nominal difference in shares then it was the ATM, and if the company used the ATM to raise cash that is a signal that the dilution will be punitive when it comes. Even so, punitive dilution is still better than the alternative.
Your idea to seriously drop the price is tempting, but the company does need to raise money. Showing product volume increases when you are practically giving away the drug is not how you encourage skeptical investors to take a position in your company; they are going to want hard financial results. The other problem is that dropping prices is easy but raising them later is much more difficult than you can imagine, because that is when managed care will push back. Sanofi was not totally crazy going to market at a premium price because they knew they could always drop it to increase volume if the demand was there, but maybe the 30% premium was a bit too aggressive.
Long-term, the marketing plan makes sense, and if the market still won't accept the drug then it was doomed as a commercial product from the start. The concern has to be having enough cash to last the short and medium terms.
Matt said the ATM and shelf registration were for just precautionary and had no plans for an offering right now. So I don't think he would turn around and sell shares the next day(unless it was to the Mann Trust). That would be irresponsible and lead to lawsuits, unless the share price skyrockets and was is in the best interest of the company. Worst case is the Mann trust bails MNKD out again. Most people think Al got all his money from selling MiniMed, and that he spent all his cash on Afrezza already, well lets take a look at a few links: From www.mannkindcorp.com/about-us-board-of-directors-alfred.htm Mr. Mann has founded and largely funded 14 companies in his career. Nine were acquired at an overall total of almost $8 billion, and three companies became public. In addition to MannKind, he is currently involved with: • Bioness, which develops and manufactures systems to address neural deficits and to restore controlled function of paralyzed limbs; • Second Sight, which is developing a visual prosthesis to restore sight to the blind; • IncuMed, which is developing novel percutaneous seals for various applications; • PerQFlo, which is developing drug delivery systems; and • RoundTrip, which is developing location and identification technology. He also got a chunk of cash from this deal www.nytimes.com/2007/08/10/business/10boston.html?_r=0So if you found and largely fund a private company what percentage do you usually own? We know MiniMed(which was public) sold for around $3 billion(looks like Al made a billion there) so what percent of that other $5 billion did Al receive?
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Post by agedhippie on Apr 28, 2016 22:19:56 GMT -5
Oh that's not a rebate, that's price cap! This is the NHS fixing the amount drug prices can rise year on year for the next few years to what they wanted to pay rather than what the pharmas wanted to charge. It is the same across all pharmas and they cannot negotiate. There is a reason rebate is in inverted commas in the FT headline! The last of those references isn't a rebate either, it is part of the system with the more expensive drugs where the pharma only gets paid if the patient is cured (no cure no pay). To the original point - the Humalog price published in MIMS is correct and there is no rebate against it. All of this is in the open with the numbers published.
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Post by peppy on Apr 29, 2016 7:11:52 GMT -5
Oh that's not a rebate, that's price cap! This is the NHS fixing the amount drug prices can rise year on year for the next few years to what they wanted to pay rather than what the pharmas wanted to charge. It is the same across all pharmas and they cannot negotiate. There is a reason rebate is in inverted commas in the FT headline! The last of those references isn't a rebate either, it is part of the system with the more expensive drugs where the pharma only gets paid if the patient is cured (no cure no pay). To the original point - the Humalog price published in MIMS is correct and there is no rebate against it. All of this is in the open with the numbers published. Aged, I have never looked at MIMS, I would like to. I tried googling MIMS. Can you or some on the board post a link so I can look at these documents? Pep
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Post by matt on Apr 29, 2016 7:44:32 GMT -5
So if you found and largely fund a private company what percentage do you usually own? I never said that MNKD was turning on the ATM full speed, just that they were doing some testing of the waters. If Matt (the other Matt, not me) says that he has no immediate plans to use the ATM then I will take him at his word, but he also said that they hadn't used the previous one while the 10-K states that shares were sold off the ATM. As for what percentage does an inventor own, that is all over the place and depends largely on how much it costs to develop the idea. Medical devices are cheaper to design, often need minimal testing if they can be covered by a 510(k) registration, and are much faster to market which all adds up to a lower cost to market. Device inventors wind up with more of their company than pharma company founders, who rarely keep more than about 20% after the IPO. If they can sell earlier than an IPO, they do somewhat better than that. It also depends how compelling the idea is and whether the venture capital funds are competing with each other for a piece of the deal or not. I have seen founders wind up with less than 5% and others who kept 100%. Al did exceptionally well with most of his companies, and deservedly so.
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Post by esstan2001 on Apr 29, 2016 8:18:11 GMT -5
The US health system is a trainwreck for sure... its capitalism . and it makes me furious.. Capitalism. Hmm.. Maybe was closer to being the case a century ago, when your Doc would visit on call. Today? It is a bastardized 3rd party payer system with a cluster - truck of Gov't bureaucracy tossed in and 17 disinterested (in health outcomes) hands grabbing for whatever money is being made available by any source. When the customer is removed from the process of negotiating the fee or price for the service, where is the incentive to control price? It too is removed. So how did we try to fix this? By adding more Gov't controls. And how's that working out? I'm an average family still waiting for my estimated $2500 annual savings, our specialist doc no longer accepts insurance. Too difficult to deal. And here I thought I could still see the same doctor. Oh, and my Ins. premiums are increasing north of 20% per annum. And yet, 50% of the health care exchanges are filing for bankruptcy. No, this is nowhere near capitalism. Cronyism? maybe somewhere in there you can find some elites skimming off vast benefit and running for the hills.
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