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Post by rfogel on Nov 14, 2019 19:17:50 GMT -5
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Post by matt on Nov 15, 2019 7:40:55 GMT -5
I looked as well and did not find it either. Based on recent years, there will be one more update just before Christmas. Without a announced PF price, Biomm is unable to sell the inventory they already have on hand either to the retail pharmacies or the government controlled entities. That will but a damper on any future orders until an official price is released so the initial shipment in late September is probably all that is going to show up in the 2019 financials. |
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Post by casualinvestor on Nov 15, 2019 15:03:07 GMT -5
Any chance Biomm is shipping out samples, or other non-price list related stuff? Also, $0.7M in product is informative from a bottom line perspective. But we have no idea how many units that was
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Post by matt on Nov 15, 2019 15:21:07 GMT -5
I don't know Brazilian law well enough to comment on how they handle samples, but all sales are price regulated and the PF price is the baseline from which all other prices are calculated. Based on an earlier application to "fast track" the approval, Biomm might be trying to get Afrezza categorized as an "incremental improvement" over regular insulin which is how various value-added insulins are priced (e.g. pre-filled injector pens). Last time Anvisa would not give them that treatment stating that only lispro and glargine qualified under that particular regulation.
I don't know what the continued hold-up is unless CMED is strictly applying the pricing rules for insulin to Afrezza and Biomm is trying to negotiate something different.
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Post by rfogel on Nov 15, 2019 16:11:27 GMT -5
I don't know Brazilian law well enough to comment on how they handle samples, but all sales are price regulated and the PF price is the baseline from which all other prices are calculated. Based on an earlier application to "fast track" the approval, Biomm might be trying to get Afrezza categorized as an "incremental improvement" over regular insulin which is how various value-added insulins are priced (e.g. pre-filled injector pens). Last time Anvisa would not give them that treatment stating that only lispro and glargine qualified under that particular regulation. I don't know what the continued hold-up is unless CMED is strictly applying the pricing rules for insulin to Afrezza and Biomm is trying to negotiate something different. Seriously, it's only been six months now. How difficult can it be to come up with a price? |
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Post by matt on Nov 15, 2019 16:20:25 GMT -5
Anvisa approves the drugs for sale, but CMED sets the maximum market price. If CMED follows their own rules as published, they have to come up with a reference price for Afrezza based on other insulins available in the local market, and those have an official price of $5-6 for 1000U. That would make importation of Afrezza a non-starter on price alone so Biomm has to negotiate something different and that may not be an easy process. If Biomm accepts an initial PF that is too low, it is nearly impossible to raise it later.
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Post by mytakeonit on Nov 15, 2019 16:22:38 GMT -5
I believe that the container got to Brazil early October.
But, that's mytakeonit
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Post by sr71 on Nov 15, 2019 16:22:57 GMT -5
I don't know Brazilian law well enough to comment on how they handle samples, but all sales are price regulated and the PF price is the baseline from which all other prices are calculated. Based on an earlier application to "fast track" the approval, Biomm might be trying to get Afrezza categorized as an "incremental improvement" over regular insulin which is how various value-added insulins are priced (e.g. pre-filled injector pens). Last time Anvisa would not give them that treatment stating that only lispro and glargine qualified under that particular regulation. I don't know what the continued hold-up is unless CMED is strictly applying the pricing rules for insulin to Afrezza and Biomm is trying to negotiate something different. Seriously, it's only been six months now. How difficult can it be to come up with a price? Does it strike anyone (besides me) as odd that Biomm would "purchase" $0.7 million of Afrezza before they even know how much they can re-sell it for in Brazil? I'm getting the uneasy feeling that Mannkind may have sold them this batch for something like the incremental cost of manufacturing, with Biomm thinking they could negotiate a better price with CMED. Maybe they are wrong? |
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Post by mytakeonit on Nov 15, 2019 16:27:34 GMT -5
Yep, they should just about be hooked on Afrezza about now. After the dry period ... they'll be willing to pay anything for the next fix.
But, that's mytakeonit
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Post by agedhippie on Nov 15, 2019 17:48:24 GMT -5
Seriously, it's only been six months now. How difficult can it be to come up with a price? Does it strike anyone (besides me) as odd that Biomm would "purchase" $0.7 million of Afrezza before they even know how much they can re-sell it for in Brazil? I'm getting the uneasy feeling that Mannkind may have sold them this batch for something like the incremental cost of manufacturing, with Biomm thinking they could negotiate a better price with CMED. Maybe they are wrong? Far more likely that as Matt said they are taking the time to get the best possible price now because going back to the well is not an option. From Biomm's point of view a couple of months delay is a price worth paying if it appreciably increases the price. As a data point; a drug they applied to CMED for that was registered two weeks before Afrezza just got approved so my feeling is that Afrezza gets approved in the next round. |
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Post by matt on Nov 16, 2019 8:22:30 GMT -5
As a data point; a drug they applied to CMED for that was registered two weeks before Afrezza just got approved so my feeling is that Afrezza gets approved in the next round. Which drug was that? As far as I know there is only one Biomm drug on the price list (a biosimilar glargine) but that one has been on the price list for months. |
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Post by rfogel on Nov 16, 2019 8:39:49 GMT -5
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Post by agedhippie on Nov 16, 2019 9:40:52 GMT -5
As a data point; a drug they applied to CMED for that was registered two weeks before Afrezza just got approved so my feeling is that Afrezza gets approved in the next round. Which drug was that? As far as I know there is only one Biomm drug on the price list (a biosimilar glargine) but that one has been on the price list for months. Herzuma - trastuzumab. They issued a PR on Nov 11th for the CMED pricing ( Press Release) and I think this is the approval we are talking about although I may well be wrong. According to the investor section on their web site it was filed a couple of weeks before Afrezza. |
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Post by lakers on Nov 16, 2019 12:17:42 GMT -5
“On Brazil they just got the product of customs a couple of weeks ago, so I don't want to comment yet on their launch plans. I know they're finishing up pricing negotiations with the government, I think until all that happens, we're just -- we know there's a lot of excitement down there, but I think we need another month or so to get the feedback on how that flows out but otherwise product down there has gone through customs. It's in the warehouse.”.
Feb is more likely.
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Post by rfogel on Nov 16, 2019 13:30:04 GMT -5
Which drug was that? As far as I know there is only one Biomm drug on the price list (a biosimilar glargine) but that one has been on the price list for months. Herzuma - trastuzumab. They issued a PR on Nov 11th for the CMED pricing ( Press Release) and I think this is the approval we are talking about although I may well be wrong. According to the investor section on their web site it was filed a couple of weeks before Afrezza. Herzuma is not on the November list published by ANVISA. Trastuzumab is but it identifies Roche as the manufacturer. Probably Biomm is just the distributor analogous to the deal with Mannkind. |
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