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Post by wyattdog on Dec 27, 2023 16:54:11 GMT -5
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Post by lennymnkd on Dec 27, 2023 18:05:36 GMT -5
Amphastar Pharmaceuticals, Inc., a bio-pharmaceutical company, develops, manufactures, markets, and sells generic and proprietary injectable, inhalation, and intranasal products in the United States, China, and France. The company operates through two segments, Finished Pharmaceutical Products and Active Pharmaceutical Ingredient (API). It offers Primatene Mist, an over-the-counter epinephrine inhalation product for the temporary relief of mild symptoms of intermittent asthma; Enoxaparin, a low molecular weight heparin to prevent and treat deep vein thrombosis; Naloxone for opioid overdose; Glucagon for injection emergency kit; and Cortrosyn, a lyophilized powder for use as a diagnostic agent in the screening of patients with adrenocortical insufficiency. The company also provides Amphadase, a bovine-sourced hyaluronidase injection to absorb and disperse other injected drugs; Epinephrine injection for the emergency treatment of allergic reactions; Lidocaine jelly, an anesthetic product for urological procedures; Lidocaine topical solution for various procedures; Phytonadione injection, a vitamin K1 injection for newborn babies; emergency syringe products for emergency use in hospital settings; morphine injection for use with patient controlled analgesia pumps; and Lorazepam injection for surgery and medical procedures. In addition, it offers Neostigmine methylsulfate injection to treat myasthenia gravis and to reverse the effects of muscle relaxants; Isoproterenol hydrochloride injection for mild or transient episodes of heart block; Ganirelix Acetate injection for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation; and Vasopressin to increase blood pressure in adults with vasodilatory shock. Further, the company distributes recombinant human insulin APIs and porcine insulin API. It serves hospitals, care facilities, alternate care sites, clinics, and doctors' offices. The company was founded in 1996 and is headquartered in Rancho Cucamonga, California.
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Post by uvula on Dec 27, 2023 18:48:30 GMT -5
Is the Amphistar press release just a standard expected thing? Or was it triggered by smaller than expected insulin purchases by mnkd?
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Post by hopingandwilling on Dec 27, 2023 19:04:20 GMT -5
Thanks for sharing this news! This filing just confirms what Sanofi demanded of MannKind when they wrote the contract for their partnership deal, back nearly 10 years ago. The internet and hypers of Afrezza were projecting that they would be selling billions of dollars in Afrezza, immediately. Sanofi made MannKind sign the contract for securing the insulin supply from this company-this way Sanofi wouldn't end up paying for insulin 'IF' they couldn't sell Afrezza. Now the manufacture of the massive contact for insulin is squeezing blood out of the turnip! Sanofi made sure they had no exposure if Afrezza was a failure---now some people know the answer to this quandary.
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Post by prcgorman2 on Dec 27, 2023 20:00:52 GMT -5
I thought it was an interesting filing but not sure what to make of it entirely. It seems like the main points are a restructuring of the agreement more in line with manufacturing and sales of Afrezza and V-Go insulin products and extends the agreement for 11 more years. That sounds like MannKind expects to be manufacturing and selling Afrezza (at least) for a long time to come. I didn’t read the entire filing and will likely have missed points of interest so happy to hear what a knowledgeable industry veteran had to say. e.g., agedhippie. |
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Post by uvula on Dec 27, 2023 20:35:06 GMT -5
I don't remember all the details, but a few years ago mnkd got a batch of insulin from somewhere but was never able to use it because they would first need to do a bunch of testing.
I am mentioning this because it means Amphistar is probably not providing the insulin used in the VGo thingy. Does mnkd have long term contracts for VGo insulin?
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Post by Thundersnow on Dec 27, 2023 20:47:05 GMT -5
I don't remember all the details, but a few years ago mnkd got a batch of insulin from somewhere but was never able to use it because they would first need to do a bunch of testing. I am mentioning this because it means Amphistar is probably not providing the insulin used in the VGo thingy. Does mnkd have long term contracts for VGo insulin? That insulin was from Pfizer when MNKD bought their facility 11+ years ago. Per Al Mann it was stored in their freezer and tested annually to make sure it was still viable. The insulin had a Zero Cost Basis (it was totally expensed) so any product sold would go to the bottom line. For about 6 years the CEO's said it was still good but then you never heard anything about it. Does anyone understand today SEC Filing? What is Inclusion Bodies? |
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Post by anderson on Dec 27, 2023 22:42:11 GMT -5
I don't remember all the details, but a few years ago mnkd got a batch of insulin from somewhere but was never able to use it because they would first need to do a bunch of testing. I am mentioning this because it means Amphistar is probably not providing the insulin used in the VGo thingy. Does mnkd have long term contracts for VGo insulin? That insulin was from Pfizer when MNKD bought their facility 11+ years ago. Per Al Mann it was stored in their freezer and tested annually to make sure it was still viable. The insulin had a Zero Cost Basis (it was totally expensed) so any product sold would go to the bottom line. For about 6 years the CEO's said it was still good but then you never heard anything about it. Does anyone understand today SEC Filing? What is Inclusion Bodies? Correct 2009 it was the Pfizer's Exubera insulin, but MNKD was blocked by Sanofi from buying the plant(https://www.outsourcing-pharma.com/Article/2009/06/09/Sanofi-swoops-for-Pfizer-insulin-plant-scuppering-MannKind-s-bid). So MNKD was paid to store the some of the insulin and bought a bunch of it and the rights to produce it for inhalation from Pfizer. It was cryo stored so may potentially be still good, at least it was several years ago when someone asked in an shareholders meeting. If Afrezza ever takes off and MNKD has the time and spare cash, they could build a plant, get FDA approval and start manufacturing it and thus vertically integrate. You would think there would be some incentives to build this type of plant in the USA to reduce reliance on foreign drug manufacturing. Also note that Amphastar bought the Merck manufacturing plant in 2014 $34.5 mil, MNKD should have bought it instead. www.marketscreener.com/quote/stock/AMPHASTAR-PHARMACEUTICALS-16783932/news/Amphastar-Pharmaceuticals-Inc-completed-the-acquisition-of-API-Manufacturing-Business-from-Merck-S-38740860/ |
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Post by agedhippie on Dec 28, 2023 7:19:43 GMT -5
That insulin was from Pfizer when MNKD bought their facility 11+ years ago. Per Al Mann it was stored in their freezer and tested annually to make sure it was still viable. The insulin had a Zero Cost Basis (it was totally expensed) so any product sold would go to the bottom line. For about 6 years the CEO's said it was still good but then you never heard anything about it. Does anyone understand today SEC Filing? What is Inclusion Bodies? It looks like Amphastar are changing their manufacturing and/or sourcing. That needs MNKD to approve the change under the terms of the supply contract. Nobody wants to play chicken as Amphastar would be in breach of contract while MNKD would be scrabbling to find a new supplier with the attendent disruption. The outcome is that MNKD gets to reduce their committed spend and Amphastar gets their change without problems - everyone wins. The inclusion bodies are interesting. As I understand it they are in the E. coli bacteria and where the insulin precursor accumulates. The precursor is stripped from the inclusion bodies and used to make insulin. More efficient inclusion bodies can accumulate more precursor and hence make more insulin. That's the sum of my knowledge from a tour of Eli Lilly's insulin plant in Indianapolis maybe fifteen years ago so it's a bit hazy. |
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Post by hellodolly on Dec 28, 2023 7:27:35 GMT -5
2.1. New Section 1.16 is added as follows: “Capacity Fee” means the amount MannKind will pay to Amphastar France Pharmaceuticals (“AFP”) every calendar quarter. The “Capacity Fee” is for a full calendar quarter, including the calendar quarter that MannKind receives FDA approval for MannKind to use the Product produced with inclusion bodies that are manufactured by Amphastar. For example, if FDA approval is on Feb. 15, 2026, then the full Capacity Fee for the first calendar quarter is due in accordance with the table in Section 6.1, following which Year 1 would start on April 1, 2026.
2.2. New Section 1.17 is added as follows: “Year 1” means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar. For example, if such FDA approval is on February 15, then Year 1 will commence on the subsequent April 1 and will end on March 31 of the following year. Year 2, 3, and so on, will be 12-month periods that commence on each anniversary of Year 1.
These are the two new sections added to the addendum (see above).
I'm not clear what they mean in their example, in subsection (2.1): "...if FDA approval is on Feb 15, 2026..."? Did they just enter into a new agreement for the purchase of a new compound? Does this have anything to do with Clofazimine, India or PEDS study?
I'm also confused in sub section (2.2): “Year 1” means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar
Twice it's mentioned "FDA approval" starts the clock on this new agreement?
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Post by hellodolly on Dec 28, 2023 7:29:39 GMT -5
That insulin was from Pfizer when MNKD bought their facility 11+ years ago. Per Al Mann it was stored in their freezer and tested annually to make sure it was still viable. The insulin had a Zero Cost Basis (it was totally expensed) so any product sold would go to the bottom line. For about 6 years the CEO's said it was still good but then you never heard anything about it. Does anyone understand today SEC Filing? What is Inclusion Bodies? It looks like Amphastar are changing their manufacturing and/or sourcing. That needs MNKD to approve the change under the terms of the supply contract. Nobody wants to play chicken as Amphastar would be in breach of contract while MNKD would be scrabbling to find a new supplier with the attendent disruption. The outcome is that MNKD gets to reduce their committed spend and Amphastar gets their change without problems - everyone wins. The inclusion bodies are interesting. As I understand it they are in the E. coli bacteria and where the insulin precursor accumulates. The precursor is stripped from the inclusion bodies and used to make insulin. More efficient inclusion bodies can accumulate more precursor and hence make more insulin. That's the sum of my knowledge from a tour of Eli Lilly's insulin plant in Indianapolis maybe fifteen years ago so it's a bit hazy. Another piece of good news that will help offset the overall COGS and see the impact directly to the bottom line. |
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Post by uvula on Dec 28, 2023 8:01:12 GMT -5
Or it might be bad news. Amphastar changed their manuf method and now mnkd has to get another fda approval before they can use the new stuff. This sounds like another expense. And what if they don't get approval?
I'm just guessing on what this all means. Not trying to spread FUD. But is also just a guess by the previous poster to say that this news is somehow a good thing.
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Post by sayhey24 on Dec 28, 2023 8:24:21 GMT -5
I don't remember all the details, but a few years ago mnkd got a batch of insulin from somewhere but was never able to use it because they would first need to do a bunch of testing. I am mentioning this because it means Amphistar is probably not providing the insulin used in the VGo thingy. Does mnkd have long term contracts for VGo insulin? The VGo thingy uses any U-100 fast acting insulin which is a separate prescription which MNKD is not supplying. With any hope 2024 will bring in some changes at MNKD and the VGo thingy will be put back in the dumpster. I see the Amphistar thingy as good news / bad news. On one hand it reduces risk on MNDKs part on required insulin purchases. On the other hand MNKD is reducing purchases rather than increasing which means less anticipated afrezza sales. |
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Post by prcgorman2 on Dec 28, 2023 10:17:34 GMT -5
I don't remember all the details, but a few years ago mnkd got a batch of insulin from somewhere but was never able to use it because they would first need to do a bunch of testing. I am mentioning this because it means Amphistar is probably not providing the insulin used in the VGo thingy. Does mnkd have long term contracts for VGo insulin? The VGo thingy uses any U-100 fast acting insulin which is a separate prescription which MNKD is not supplying. With any hope 2024 will bring in some changes at MNKD and the VGo thingy will be put back in the dumpster. I see the Amphistar thingy as good news / bad news. On one hand it reduces risk on MNDKs part on required insulin purchases. On the other hand MNKD is reducing purchases rather than increasing which means less anticipated afrezza sales. The Afrezza sales run rate is well established. If it changes enough to worry about needing more insulin, that will be a good problem to have (in 2025 or 2026?). Reducing the cost of the Amphistar obligation in the near term is a good thing. |
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Post by wyattdog on Dec 28, 2023 10:25:48 GMT -5
different read on same subject: MannKind Restructures Supply Agreement with Amphastar Pharmaceuticals
9:13 AM ET, 12/28/2023 - MT Newswires
09:13 AM EST, 12/28/2023 (MT Newswires) -- MannKind (MNKD) has made a seventh amendment to its supply agreement with Amphastar Pharmaceuticals (AMPH) adjusting purchase commitments and introducing capacity fees, according to a regulatory filing with the US Securities and Exchange Commission late Wednesday.
The revised annual purchase commitments range from 2.9 million euros ($3.2 million) in 2024 to 4.4 million euros in year nine with the new inclusion bodies, compared with the previous commitment total of 58.7 million euros for calendar years 2024 to 2027, according to the company.
The amended agreement's term extends until Dec. 31, 2035, or the completion of all purchase commitments.
Price: 3.67, Change: +0.01, Percent Change: +0.23
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