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Brazil
Oct 10, 2019 13:26:38 GMT -5
via mobile
Post by veritasfiliatemporis on Oct 10, 2019 13:26:38 GMT -5
Too many idiots on this post... |
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Post by matt on Oct 10, 2019 13:47:41 GMT -5
My sense for success in Brazil is not whether Afrezza sells $20m plus per year in Brazil but more the following: 1. Does mnkd sell enough to lower the average cost of goods sold here in the States, thus increasing margins, which may allow them to lower price in the States. 2. Does Afrezza get a better label or at least officially eliminate the need for refrigeration in Brazil. 3. How popular does it become in the pwd community in Brazil. As far as retail sales revenue, as many have mentioned, I would not count on very big numbers. GLTAL's!!! Here is my take-away from looking pretty hard at the Brazilian market, both now and over the past few decades: 1. Maybe. See comment 3. 2. I don't see how there will be a better label without better studies. CMED was established, in large part, to keep foreign drug companies from constantly ratcheting up prices for Brazil and the criteria they use to price new drugs requires that the drug do a better job of treating the disease than something already on the market (the other two permitted criteria are same efficacy with fewer adverse events and same efficacy with lower total cost of treatment). If the drug does not meet this requirement it is priced similar to other drugs containing the same active ingredient. See the table that I did above for competitive products and ask whether that pricing would be break-even for Mannkind given that Biomm has to make something on the deal as well. The Preço Fábrica (PF), or "Factory Price, set by CMED will determine the success or failure of Afrezza. 3. That will depend on CMED pricing in large part. If CMED prices Afrezza similar to Novolog and Humalog, then Afrezza may get its fair share of the market unencumbered by formulary restrictions. However, if the permitted PF is less than $20 for a comparable supply of Afrezza then it is not clear that this can be a profitable market. My guess, and this is purely a guess, is that Biomm is trying to get an introductory price as an innovative drug that does a better job of treating diabetes than products already on the market . However, that comment on the US label that points out that reduction in A1c was less than with Lispro may come back to haunt the company. As the regulations read in black and white, and based on what FDA has approved on the label, it is hard to argue that Afrezza meets any of the criteria for a Category I innovative drug, which then requires it to be a Category II drug where the price is set according to cost of treatment with drugs marketed for the same therapeutic indication and with reference to the same active ingredient. Trumpeting that Afrezza is "just insulin" is not helpful if the authorities are looking to price it based on market comparables. Recall that when Biomm attempted to have approval of Afrezza fast tracked they were shot down in part because ANVISA declined to characterize Afrezza as an "incremental innovation", looking only to the active ingredient (Amphastar supplied insulin) and not at all at the delivery method. Indeed, if the authorities focus on insulin as the comparable active ingredient without regard to the delivery method then it will be hard to get economically acceptable pricing. That is good for the diabetics, but not so good for Mannkind. While that may seem like CMED stacks the deck to keep foreign pharmaceuticals out of Brazil to give the local manufacturers a leg up, that is precisely what was intended when CMED was established. It is not a level playing field for foreign companies even if they have a local partner. |
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Post by mannmade on Oct 10, 2019 14:10:43 GMT -5
Matt, I don't disagree with anything you posted above. My real point was that even if sold at break even, if sold in enough quantity, the added production for Brazil might lower the average cost of goods enough to increase margins on US sales and allow for a slight price reduction.
The second point was that I had heard here on the board that Brazil may not instruct that Afrezza needs refrigeration. While this would only apply to Brazil it would stil be newsworthy here in the States, even if only for off label. Was not and am not expecting any label changes other than possible refrigeration requirement as it stands now.
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Post by mytakeonit on Oct 10, 2019 14:12:19 GMT -5
Okay, so let's bring the container back and scrap the whole deal.  Or, we can continue and see how Biomm handles the distribution. But, that's mytakeonit |
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Post by mango on Oct 10, 2019 14:42:08 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq.
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Post by akemp3000 on Oct 10, 2019 15:14:57 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq. Love it. If that happens and the results are shared globally which would be likely, there will be significant exponential growth that follows. It's all just been a matter of time before the newer and improved science and technology wins out. |
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Post by harryx1 on Oct 10, 2019 15:24:34 GMT -5
When we look back, the invention of inhaled insulin (monomer insulin which happened in 2015) will be bigger than automated insulin delivery that still uses liquid insulin (hexamer)... but, that's mytakeonit.   |
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Post by mannmade on Oct 10, 2019 15:35:40 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq. Love it. If that happens and the results are shared globally which would be likely, there will be significant exponential growth that follows. It's all just been a matter of time before the newer and improved science and technology wins out. Have to agree here. Saw a commercial for libre cgm in Dodgers v Nationals playoff game yesterday! TIR baby!!! |
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Post by agedhippie on Oct 10, 2019 15:49:57 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq. I suspect hospitals will carry on as before because they have procedures laid down for managing diabetes. It's a lot of work to get those changed. People on Afrezza could continue to use it though, I always manage my own diabetes in hospital when possible (not least because they have harpoons for lancets...) as I can do a better job since I have time that nurses don't. |
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Post by cretin11 on Oct 10, 2019 16:44:50 GMT -5
Matt, thanks as always for your take on things with supporting info. You've been following MNKD for a long time now, and you have decades of relevant experience in the industry. Boiling down all of the variables, unknowns and TBDs, etc., if you had to make a prediction on where MNKD share price will be in one year, what would you predict? |
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Brazil
Oct 10, 2019 16:58:34 GMT -5
Post by ktim on Oct 10, 2019 16:58:34 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq. Love it. If that happens and the results are shared globally which would be likely, there will be significant exponential growth that follows. It's all just been a matter of time before the newer and improved science and technology wins out. So you're saying it is like the rockets, obvious that eventually they soar off towards space if one looks at them long enough?  |
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Post by mango on Oct 10, 2019 17:37:31 GMT -5
Prediction: Afrezza will be used in hospitals in Brazil as both, an alternative (better) to subq, and as an eco-environmental solution to subq. I suspect hospitals will carry on as before because they have procedures laid down for managing diabetes. It's a lot of work to get those changed. People on Afrezza could continue to use it though, I always manage my own diabetes in hospital when possible (not least because they have harpoons for lancets...) as I can do a better job since I have time that nurses don't. “The arrival of inhalable insulin is also intended as an alternative to the high production of hospital waste caused by the disposable pen method.” www2.ufjf.br/noticias/2019/10/04/palestra-aborda-aplicacao-de-insulina-inalavel/Read more: mnkd.proboards.com/thread/11417/brazil?page=8#ixzz61zehtJnm |
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Brazil
Oct 10, 2019 19:02:42 GMT -5
Post by agedhippie on Oct 10, 2019 19:02:42 GMT -5
I suspect hospitals will carry on as before because they have procedures laid down for managing diabetes. It's a lot of work to get those changed. People on Afrezza could continue to use it though, I always manage my own diabetes in hospital when possible (not least because they have harpoons for lancets...) as I can do a better job since I have time that nurses don't. “The arrival of inhalable insulin is also intended as an alternative to the high production of hospital waste caused by the disposable pen method.” www2.ufjf.br/noticias/2019/10/04/palestra-aborda-aplicacao-de-insulina-inalavel/I can't see that being a significant contributor. Pens already limit waste by removing the need for syringes (1 pen replaces about 50 syringes). They incinerate the needles, but that a tiny volume. |
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Post by mytakeonit on Oct 10, 2019 19:38:33 GMT -5
I believe that mango was pointing you to "intended as an alternative to the high production of hospital waste"
But, that's mytakeonit
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Brazil
Oct 10, 2019 22:33:33 GMT -5
Post by agedhippie on Oct 10, 2019 22:33:33 GMT -5
I believe that mango was pointing you to "intended as an alternative to the high production of hospital waste" But, that's mytakeonit I get that, but my experience is that there is a minimal amount of waste generated. If they dispense an insulin pen then you get to keep it when you are discharged, otherwise at my usage rate I get through a pen every two weeks or so. The hospital has to deal with the needles used, but that is tiny and shrinks to nothing when it's incinerated which is what happens. If they are using an IV then that's drawn from a vial. In the end, provided they are not using syringes (and the article specifically mentions pens) there is very little waste generated. |
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Or, we can continue and see how Biomm handles the distribution.
