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Post by matt on Dec 19, 2019 9:32:51 GMT -5
ktim - it seems "bad clinical results" is off the table - 1. Agent has received evidence satisfactory to it, in its discretion, that United Therapeutics has received positive clinical data on the Phase 1b BREEZE trial 2. Agent has received evidence satisfactory to it (in its discretion) that United Therapeutics definitively intends promptly to file or has filed Treprostinil Technosphere for approval by Food and Drug Administration of the United States of America for the treatment of Pulmonary Arterial Hypertension The amendment doesn't say that those events have happened. It says that those events must happen as a condition of further financing. If UTHR balks on either point the conditions precedent to further financing are not met. Elsewhere Neil36 said " If we are currently averaging about $1.3 million per week, getting up to $1.8 million is achievable, but to average that would mean retail sales would need to be well north of $2 million per week in the second half of 2020." I think that is fairly realistic math, but the caveat is that average means average of all weeks. Hitting the target sales in most weeks is not good enough since the covenants do not take into account short weeks, holidays, bad weather, etc. and other reasons why a bad week occurs. I think it is time shareholders stop mentally adjusting the weekly sales for such events and start expecting steady results week in and week out. The lender certainly requires that.
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Post by matt on Dec 18, 2019 9:15:28 GMT -5
So...the perspective is that the 19 to 30.24% increase in institutional holdings is due to tracker buyers expecting that the stock will remain flat? Wow, that's heavy. Fortunately, most believe an increase in institutional holdings is good news. Most market analysts add weight to institutional buying. No, the institutional increase is due to people putting more money into tracker funds rather than trying to select individual stocks. If 100 new customers show up on Monday with $1,000 to invest then the fund has to place $100,000 that day in stocks that are part of the index. Conversely, if those same customers decide to sell out then the fund has to liquidate $100,000. The fund manager cannot afford to be pro-Mannkind or anti-Mannkind; their job is to match the index returns regardless of which stocks make up the index. Not surprisingly, most of the trading decisions are done by computer algorithms and not a human. Remember too how the institutional reporting rules work. Companies like Blackrock manage many funds in addition to index trackers. Some of these are self-directed IRAs, 401(k) plans, and so on. If individual investors have a 401(k) through their employer that allows them to make investment decisions, but Blackrock is custodian for the plan, then those individual trades show up as "Blackrock". Since all funds managed by the same entity are allowed to be combined for purposes of Section 13 reporting, nobody can really tell which component fund is making buying, selling, or holding decisions. This holds true for all the major fund wholesalers which is why you see Blackrock, State Street, Fidelity and a few others showing up as a top holder for most stocks. Increases in institutional holdings are positive if the flow is coming from the "smart money"; funds with full-time healthcare analysts that make conscious investment decisions intended to boost fund returns over those of the market. There are a few top healthcare funds, like Orbimed, that are definitely recognized as smart money and a major change in their holdings would be a buy or sell signal. The others . . . not so much.
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Post by matt on Dec 17, 2019 17:58:02 GMT -5
Well, although they may not want to brag about the pricing, it still means they're now officially allowed to sell the drug. I'm having a bit of trouble buying the clerical error explanation. I mean, for the whole afrezza section to totally disappear just seems more organized than error. It depends what the error was. If ANVISA started over with the spreadsheet from November (which did not contain the Afrezza data either) then it is entirely plausible that they fixed some problems but forgot to include the new products for December in Version 2. Given that this is a 27,000 row spreadsheet it would not be surprising that missing a few rows went unnoticed. At any rate, Biomm is now allowed to see the drug they have on hand and can communicate the pricing to retail pharmacies. It will be interesting to see if they launch it any faster than Sanofi or MKND did in the US. If they burn through all $700,000 of the initial product and have to order more before the end of Q1, that would be a good indicator.
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Post by matt on Dec 17, 2019 11:40:30 GMT -5
I'm surprised Mannkind hasn't issued some sort of press release announcing that Brazil pricing has been determined and/or explaining afrezza's disappearance from the revised Anvisa list. They are probably waiting for it to resolve. BIOMM have not issued a PR either. Ultimately clerical errors (which I suspect is the case here with the disappearance of Afrezza in the V2 spreadsheet) are the responsibility of the marketing partner to handle. However, CMED has made their determination of pricing, consistent with government guidelines, so the numbers are unlikely to change.
Given the very modest prices awarded by CMED, is that something either company (MNKD or Biomm) wants to PR? SEC rules certainly don't require it.
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Post by matt on Dec 14, 2019 14:00:36 GMT -5
My guess it was the Chinese. 😉 C'mon - we all know it was the Russians ;O Now we know why Epstein was killed. The timing is too perfect, just sayin.
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Post by matt on Dec 14, 2019 11:04:08 GMT -5
The prices for Afrezza are no longer there. I noticed that the Excel spreadsheet that gets downloaded today is named: xls_conformidade_2019_12_10_v2.xls Notice the "v2" at the end. The one I took those prices from must have been version 1, but the prices were in there a few days ago. I don't know why there was a second version published or why Afrezza was part of the first release but not the second. However, several of us saw it in the first day after it was posted. If it's not too much trouble, how different are the spreadsheets? Do they appear to differ (e.g. by line count) by much more than would be accounted for by the Afrezza deletion alone? opini I didn't keep a copy of version 1 so I can't answer the question. However, the spreadsheet covers EVERY drug and dosing combination in Brazil and its runs nearly 26,000 rows. I assume somebody made an administrative error and this is not directed at MNKD in particular, but opinions may differ on that point. The post above from Sportsrancho shows part of the sheet, in this case the first column is the "factory price" plus some additional amount which I think is equivalent to the ICMP charge (an extra tax on imported drugs not applied to domestic production). Maybe there is a version 3 in our future, but the prices that were announced are consistent with Brazil's stated goals to limit the import of drugs otherwise available from local producers and to control prices to keep them in line with similar products already on the market. Note that a 10ml vial of 100U recombinant insulin from a local producer is only about $6 so it looks like CMED is enforcing their rules.
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Post by matt on Dec 13, 2019 17:55:07 GMT -5
The prices for Afrezza are no longer there. I noticed that the Excel spreadsheet that gets downloaded today is named:
xls_conformidade_2019_12_10_v2.xls
Notice the "v2" at the end. The one I took those prices from must have been version 1, but the prices were in there a few days ago. I don't know why there was a second version published or why Afrezza was part of the first release but not the second. However, several of us saw it in the first day after it was posted.
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Post by matt on Dec 11, 2019 15:39:55 GMT -5
Does anyone know if they can immediately start selling/filling prescriptions, or is there more ramp-up/waiting time? I think that the pricing was the last requirement; ANVISA approved the drug back in May. Most diabetics in Brazil get their insulin, which is supplied by government owned non-profit production centers, at the "Farmacia Popular" where the drugs are free. The trick is to get distribution in the pharmacies that are full service, for profit centers, and to get physicians to write scripts. I noted that there was no PMVG price announced which suggests the government will not be buying Afrezza for the Farmacia Popular.
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Post by matt on Dec 11, 2019 9:44:57 GMT -5
Does anyone have a guess if we are selling at “cost” to Brazil? I’m all for increasing volume and awareness world wide, but I hope we are not selling at below manufacturing cost. I am not sure the permitted factory price even covers cost. The factory price is the maximum that Biomm can charge retail pharmacies (before taxes) so Biomm must recover all of their costs out of that price including what they pay to MNKD for the product, shipping, warehousing in Brazil, sales and marketing, and so forth. Pure selling activities for a specialty pharmaceutical product are in the ballpark of 35% of sales in normal circumstances (that is roughly what Biomm would spend to promote the drug), so if MNKD is only receiving 65% of the factory price, net of international shipping cost, then there is not much room left to cover production costs.
Given that it has taken MNKD until this year to have a positive contribution margin on Afrezza, I can't see how the allowed price comes close to covering the fully burdened manufacturing cost. The allowed price might cover the pure incremental manufacturing cost if you assume that the excess bulk insulin inventory has no economic value and that the depreciation and other manufacturing costs are truly fixed with or without the Brazil volume. The cost to print Portuguese labels is minimal.
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Post by matt on Dec 11, 2019 9:31:15 GMT -5
50.77 / 1020 = ? so Brazil prices are about 5% of US prices for the consumer Yes, my bad. I used the factory price to US consumer price.
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Post by matt on Dec 11, 2019 8:48:27 GMT -5
Afrezza pricing finally announced in Brazil. The official prices in Brazilian Reals (US dollars in parentheses) are:
8U X 90 70.63 ($17.14) 12U X 90 1 05.95 ($25.71) 4U X 60, 8U X 30 47.09 ($11.43) 4U X 30, 8U X 60 58.86 ($14.29) 8U X 60, 12U X 30 82.41 ($20.00) 4U X 90, 8U X 90 105.95 ($25.71) These are “factory prices” and represent the maximum amount Biomm can charge any pharmacy for the product. MNKD is paid from the factory price.
The maximum price that can be charged to consumers depends on the state in which they live since the controlled prices include all taxes. However, for reference the 12U X 90 pack has a maximum consumer price of 209.11 ($50.77) in the states with the highest tax rate, so about double the factory price. The difference between the “factory price” and the “maximum consumer price” goes to sales taxes, import duty on foreign medicines, and includes a retail markup of approximately 32% for the pharmacy.
For reference, GoodRx shows a lowest price for the 12U x 90 kit of $1,020 at Costco, so Brazil prices are about 2.5% of US prices for the consumer.
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Post by matt on Nov 29, 2019 11:33:43 GMT -5
Out of the blue maybe? I just got the notification about this event this morning from MannKind Isn't this conference another one of those companies go to in search of funding? 100% of all financial conferences sponsored by investment banks are promotional activities that the bank hopes will result in fees, either from fund raises executed on behalf of growth companies that need capital or merger/acquisition fees from more established companies. Nobody does anything for free, and investment banks have to get fees to stay in business and this is just how the game is played. The good news is that Piper is a notch up from H.C. Wainwright (aka Rodman & Renshaw) and some of the other banks MNKD has previously been using. Whether Piper can generate enough interest to pull off a deal for MNKD remains to be seen. If too many conferences go by with no deals coming to fruition, companies don't get invited back by the sponsor.
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Post by matt on Nov 22, 2019 8:54:51 GMT -5
So the least a director gets is $150,000 in stock plus $50,000 in cash or stock? That seems like a lot. How does it compare to other small biotechs? The cash retainer is about average, the committee fees are average to slightly higher than average, but there are no meeting fees so on balance I would say the total cash compensation is pretty typical. I normally expect to see a board cash compensation package for a small cap NASDAQ stock that runs about $75,000 per year when everything is included. MNKD is squarely in the ballpark for cash compensation when committee fees are considered. The stock-based compensation is a lot higher than average. Most companies offer options and/or discounted stock purchase programs but $150,000 worth of restricted stock seems way over the top for a company this size. Combined with the cash compensation, even if the stock does not increase a penny the directors are certain to make around $225,000 per year. That is a lot of money for service on the board of a smallish pharma company, especially one that is not performing well in the market.
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Post by matt on Nov 16, 2019 17:33:51 GMT -5
Thanks, I knew they had that drug pending. Their web site says "The new drug will be marketed through a partnership between Brazilian pharmaceutical industry Biomm, a pioneer in the biotechnology segment for medicines in the country, and South Korean Celltrion Healthcare (CHTC), one of the world's leading biopharmaceuticals." and indeed there is a PF price listed under the Celltrion name but that is for influximab (Remicade) which is a different mAb than trastuzumab. The price is 1873 Reals for 10mg which is much less than the 3289 for the Janssen product (a division of J&J) and the 3289 from Foundation Oswaldo Cruz, a local manufacturer owned by the State of Rio de Janeiro.
I only found two sources for trastuzumab, one for Roche and one for Libbs which is a privately owned Brazilian company.
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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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