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Post by itellthefuture777 on Aug 16, 2021 5:30:33 GMT -5
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Post by hellodolly on Aug 16, 2021 5:39:33 GMT -5
Supply agreement with UTHR.
Item 1.01. Entry into a Material Definitive Agreement.
On August 12, 2021, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) entered into a commercial supply agreement (the “Supply Agreement”), pursuant to which MannKind is responsible for manufacturing and supplying to United Therapeutics, and United Therapeutics is responsible for purchasing from MannKind, Tyvaso DPI™ (inhaled treprostinil) and BluHale® inhalation profiling devices (collectively, “Products”), as required for commercial distribution and sale by United Therapeutics.
Under the terms of the Supply Agreement, MannKind will be responsible for manufacturing Products in its Danbury, Conn. facility in accordance with agreed-upon specifications and quality standards. United Therapeutics will purchase Products from MannKind on a cost-plus basis. United Therapeutics is responsible for supplying treprostinil used to produce Tyvaso DPI to MannKind in quantities necessary to enable MannKind to manufacture Products as required by the Supply Agreement, at United Therapeutics’ expense.
Unless earlier terminated, the term of the Supply Agreement continues until August 12, 2026 and is thereafter renewed automatically for additional, successive two-year terms unless either party gives 24 months’ written notice of non-renewal prior to the end of the initial term or any additional renewal term. MannKind and United Therapeutics each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party.
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Post by akemp3000 on Aug 16, 2021 6:23:36 GMT -5
Is this simply a required material event document defining the terms of the automatic renewals?
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Post by uvula on Aug 16, 2021 7:48:10 GMT -5
Sounds like the Amphistar agreement except no minimum quantities or dollar amounts are stated.
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Post by MnkdWASmyRtrmntPlan on Aug 16, 2021 8:12:54 GMT -5
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Post by sayhey24 on Aug 16, 2021 8:20:24 GMT -5
How is this like the Amphistar agreement? This is a cost plus contract for MNKD to manufacture and UTHR to buy from MNKD Tyvaso DPI™ (inhaled treprostinil) and BluHale. I don't know what the plus-up is on the cost, maybe 6 to 10%? Don't they also get a royalty on sales?
IDK but this agreement could make MNKD profitable.
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Post by itellthefuture777 on Aug 16, 2021 9:55:33 GMT -5
Here's what I see here...Rocket Blast to 2026..then..orbit around Mars..
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Post by agedhippie on Aug 16, 2021 10:25:15 GMT -5
How is this like the Amphistar agreement? This is a cost plus contract for MNKD to manufacture and UTHR to buy from MNKD Tyvaso DPI™ (inhaled treprostinil) and BluHale. I don't know what the plus-up is on the cost, maybe 6 to 10%? Don't they also get a royalty on sales? IDK but this agreement could make MNKD profitable. There is a royalty on sale, and the cost plus deal on manufacturing. This seems like a pretty standard deal. UTHR is not going to make a committed buy at this point because they don't want to be stuck with a load of drugs that they cannot move (ref: Mannkind and Amphastar insulin). Instead they settle for a lower margin and the safety of being able to walk away at zero cost by transferring the risk to Mannkind if the drug flops. This approach, cost plus, is fairly standard when the volumes are unclear. Mannkind gets more than they would have per unit, and UTHR get flexibility. If the drug really takes off expect UTHR to renegotiate well before 2026. |
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Post by longliner on Aug 16, 2021 11:09:49 GMT -5
If the drug really takes off expect a buyout before then.
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Post by olderteampt on Aug 16, 2021 11:10:18 GMT -5
Yes, and that renegotiation could be a buyout well before 2026
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Post by peppy on Aug 16, 2021 12:19:30 GMT -5
How is this like the Amphistar agreement? This is a cost plus contract for MNKD to manufacture and UTHR to buy from MNKD Tyvaso DPI™ (inhaled treprostinil) and BluHale. I don't know what the plus-up is on the cost, maybe 6 to 10%? Don't they also get a royalty on sales? IDK but this agreement could make MNKD profitable. There is a royalty on sale, and the cost plus deal on manufacturing. This seems like a pretty standard deal. UTHR is not going to make a committed buy at this point because they don't want to be stuck with a load of drugs that they cannot move (ref: Mannkind and Amphastar insulin). Instead they settle for a lower margin and the safety of being able to walk away at zero cost by transferring the risk to Mannkind if the drug flops. This approach, cost plus, is fairly standard when the volumes are unclear. Mannkind gets more than they would have per unit, and UTHR get flexibility. If the drug really takes off expect UTHR to renegotiate well before 2026. As soon as UTHR gets approval, I bet an order goes in for samples. Hello agedhippie |
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Post by sayhey24 on Aug 16, 2021 12:52:00 GMT -5
How is this like the Amphistar agreement? This is a cost plus contract for MNKD to manufacture and UTHR to buy from MNKD Tyvaso DPI™ (inhaled treprostinil) and BluHale. I don't know what the plus-up is on the cost, maybe 6 to 10%? Don't they also get a royalty on sales? IDK but this agreement could make MNKD profitable. There is a royalty on sale, and the cost plus deal on manufacturing. This seems like a pretty standard deal. UTHR is not going to make a committed buy at this point because they don't want to be stuck with a load of drugs that they cannot move (ref: Mannkind and Amphastar insulin). Instead they settle for a lower margin and the safety of being able to walk away at zero cost by transferring the risk to Mannkind if the drug flops. This approach, cost plus, is fairly standard when the volumes are unclear. Mannkind gets more than they would have per unit, and UTHR get flexibility. If the drug really takes off expect UTHR to renegotiate well before 2026. A committed buy? They are already neck deep into this deal when they paid for the manufacturing facility. A few boxes of Tyvaso DPI at this point is the least of their worries. I am sure there is already an initial manufacturing schedule to jump start things. After that we will see. |
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Post by akemp3000 on Aug 16, 2021 12:57:54 GMT -5
I could be mistaken but I thought MC said something about $14M in revenue anticipated for manufacturing in Q3. If so, this would be for samples and more in anticipation of the approval. Maybe somebody can clarify. Regardless, I wouldn't think UTHR would pay $105M to expedite approval then wait for the approval before ordering the first samples. Just guessing but I'd bet they'll have a limited product supply and hit the ground running immediately upon approval.
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Post by sayhey24 on Aug 16, 2021 13:10:15 GMT -5
The $105M is a good point. Then add in the manufacturing facility cost and UTHR is in up to their eyeballs.
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Post by itellthefuture777 on Aug 16, 2021 13:18:39 GMT -5
I could be mistaken but I thought MC said something about $14M in revenue anticipated for manufacturing in Q3. If so, this would be for samples and more in anticipation of the approval. Maybe somebody can clarify. Regardless, I wouldn't think UTHR would pay $105M to expedite approval then wait for the approval before ordering the first samples. Just guessing but I'd bet they'll have a limited product supply and hit the ground running immediately upon approval. Nurse training equipment..hmm |
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