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Post by longliner on Jan 21, 2023 12:03:47 GMT -5
Have you ever known agedhippie to put anything forward regarding afrezza that wasn't a roadblock?  Somebody has to answer the questions  The Marlboro Man of Nordisk.......... |
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Post by ronw77077 on Jan 21, 2023 12:40:42 GMT -5
This discussion of UT's manufacturing strategy is extremely interesting. Recently, I posted my insights on the financial projections topic but much of it is applicable here. So, I will repeat some of those observations. DPI will clearly be the predominant product UT sells through at least 2025-2026. Having a secondary manufacturing facility producing DPI is essential for UT to remove a primary business risk, that of not being able to produce sufficient quantities of DPI were something to happen to the Danbury facility. Risks include a fire or anything else that could produce even a temporary shutdown. And, they must actually have it in operation, not simply as a backup. When you look at the data below you can see how great the risk of business interruption could be.
From UT’s 1/10 JP Morgan presentation:
Martine restated their goal of growing from 12,000 PAH users today to 25,000 by 2025. She stated that they had reached 6,000 Tyvaso users by the end of 2022. They ended the quarter with a 50/50 split between Tyvaso Nebulizer and DPI users. Therefore, the other 6,000 must be patients using their other products.
UT indicated that most of the DPI sales in Q4 were from newer ILD users and that they expected the significant shift of Tyvaso users who want to switch to DPI to do so in the next 6-9 months, with the remainder of those who want to switch doing so by year end 2023.
UT maintains a two-year supply of its drug products, a second protection against business interruption, no doubt supplemented by business interruption insurance.
There will be no revenue from new products such as Ralinepag or from IPF (Fibrosis) before 2026. Therefore, all growth prior to then will come from the current product line. Look at the product line revenues reported in the UT 10-Q at 9/30/22 (data in $ millions):
Net Product Sales 3 mos. Ended Sept. 30 2022
Tyvaso Remodulin Orenitram Unituxin Adcirca Total
258 114 87 46 11 516
Net Product Sales 3 mos. Ended Sept. 30 2021
Tyvaso Remodulin Orenitram Unituxin Adcirca Total
164 125 85 55 15 445
Net Product Sales 9 mos. Ended Sept. 30 2022
Tyvaso Remodulin Orenitram Unituxin Adcirca Total
631 378 249 146 31 1439
Net Product Sales 9 mos. Ended Sept. 30 2021
Tyvaso Remodulin Orenitram Unituxin Adcirca Total
441 395 234 152 48 1270
The only product line growing is Tyvaso and that growth is from DPI. Therefore, the great majority of new 13,000 PAH customers will be using DPI. UT will have at least one other manufacturing facility.
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Post by sayhey24 on Jan 22, 2023 6:33:07 GMT -5
Ron - what are your expectations from the additional manufacturing facility? "UT will have at least one other manufacturing facility."
If I remember correctly the fill rate is 400 cartridges per minute which provides 24,000 per hour. Tyvaso DPI requires 4 cartridges per day per user or 52,000 per day for the 13,000 users. In theory the existing Danbury facility can provide all that is needed in 1/2 of the 1st shift.
I think UTHR needs the facility for disaster recovery requirements.
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Post by ronw77077 on Jan 22, 2023 10:54:56 GMT -5
Candidly, I had no knowledge of the production rate. I also have little knowledge about the manufacturing facility expansion which I understand is underway and is being funded by UT. That being the case, I presume UT foresees greater volume demand than can be produced at the current facility.
Since Martine has indicated that approval of DPI for IPF (Fibrosis) sufferers would expand the DPI customer base significantly I presume they have in mind to be able to meet that demand with production in 2025.
If I were running the business I would not rely upon a disaster recovery facility - unless it was already producing and could be used to shift production.
Frankly, I usually find myself grasping at the conflicting information such as you have presented to make estimates. Thanks for your insights.
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Post by phdedieu12 on Jan 22, 2023 11:03:43 GMT -5
Ron - The current factory expansion should 10X production when completed, but logic dictates that another manufacturing facility, even just as a backup, will be built
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Post by prcgorman2 on Jan 22, 2023 11:24:46 GMT -5
Disaster recovery and business continuity planning is a strategic part of every business regardless of whether the business owners know it or take it seriously. Given there was a fire that injured a worker at the Danbury plant within the last few months, alternate facilities in a geographically diverse location could make sense from DR/BC perspective regardless of manufacturing capacity and product supply requirements.
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Post by ronw77077 on Jan 23, 2023 13:20:56 GMT -5
It's amazing that the new facility will be able to increase production 10X. Also surprising that MNKD hasn't had focused attention to this. What could be a better signal to the market about the company's growth opportunity than stating "10X" construction capability underway. Thanks for the info.
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Post by phdedieu12 on Jan 23, 2023 13:42:22 GMT -5
Well, it's one thing to increase our capability to make product, and another to actually do that. I suspect it's meaningless until we actually produce those goods. It's a good signal, I agree, but not consequential enough, for now
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Post by ronw77077 on Jan 23, 2023 14:19:38 GMT -5
Absolutely correct. By the way, what's the basis of "The current factory expansion should 10X production when completed".
Do you have any further info about it, such as when is completion expected, and who will own it (i.e., UT or MNKD)? Thanks.
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Post by phdedieu12 on Jan 23, 2023 14:36:23 GMT -5
Absolutely correct. By the way, what's the basis of "The current factory expansion should 10X production when completed". Do you have any further info about it, such as when is completion expected, and who will own it (i.e., UT or MNKD)? Thanks. I asked MC |
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Post by sayhey24 on Jan 23, 2023 14:46:53 GMT -5
Candidly, I had no knowledge of the production rate. I also have little knowledge about the manufacturing facility expansion which I understand is underway and is being funded by UT. That being the case, I presume UT foresees greater volume demand than can be produced at the current facility. Since Martine has indicated that approval of DPI for IPF (Fibrosis) sufferers would expand the DPI customer base significantly I presume they have in mind to be able to meet that demand with production in 2025. If I were running the business I would not rely upon a disaster recovery facility - unless it was already producing and could be used to shift production. Frankly, I usually find myself grasping at the conflicting information such as you have presented to make estimates. Thanks for your insights. When I had to build disaster recovery sites the auditors required at least 400 miles between sites but they could be in the same time zone. The NC site meets that requirement. I would not read anything more into this new site. They will probably need to run a disaster recovery test yearly but maybe twice a year. My guess is MNKD Danbury staff would probably go to NC to do the test. The most cost effective approach if they needed production capacity would be to brew the powder in Danbury and then ship to NC to fill. However with only 13k patients capacity at Danbury for Tyvaso DPI is not an issue. They don't need to run for 4 hours to fill enough cartridges. Even if that doubled for Fibrosis they would not need a second shift. Hopefully for the annual meeting we can all get back to Danbury and see how they now have things configured with afrezza and Tyvaso DPI. What conflicting info which I have provided is confusing? I usually say the same thing over and over like a broken record. |
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Post by akemp3000 on Jan 23, 2023 15:00:41 GMT -5
At some point UTHR is going to want to acquire and control 100% of their PAH supply chain of which Mannkind currently has a nice piece. This is logical and common among BPs. It's especially true when a global supply chain is required which has many additional challenging issues. It's possible that once a new UTHR plant is up in a few years, it becomes the primary DPI supplier with the Danbury facility as emergency backup while it's primary function becomes producing other drugs such as Clofazimine TS.
Some might suggest UTHR can now see the potential of TS and might prefer to go ahead and acquire Mannkind in total. This is doubtful for several reasons that include Mannkind seeing the potential even better and would wisely require an unacceptably high price. If another BP comes into the picture with a partnership and interest, this could get interesting to say the least. All IMO and wildly speculating what might be ahead.
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Post by mango on Jan 23, 2023 15:20:13 GMT -5
At some point UTHR is going to want to acquire and control 100% of their PAH supply chain of which Mannkind currently has a nice piece. This is logical and common among BPs. It's especially true when a global supply chain is required which has many additional challenging issues. It's possible that once a new UTHR plant is up in a few years, it becomes the primary DPI supplier with the Danbury facility as emergency backup while it's primary function becomes producing other drugs such as Clofazimine TS. Some might suggest UTHR can now see the potential of TS and might prefer to go ahead and acquire Mannkind in total. This is doubtful for several reasons that include Mannkind seeing the potential even better and would wisely require an unacceptably high price. If another BP comes into the picture with a partnership and interest, this could get interesting to say the least. All IMO and wildly speculating what might be ahead. United was originally meant to manufacture long term supply. Straight from the original PR on the partnership: “Long-term commercial supplies will be manufactured by United Therapeutics.” investors.mannkindcorp.com/news-releases/news-release-details/united-therapeutics-and-mannkind-announce-collaboration |
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Post by sayhey24 on Jan 23, 2023 16:10:21 GMT -5
At some point UTHR is going to want to acquire and control 100% of their PAH supply chain of which Mannkind currently has a nice piece. This is logical and common among BPs. It's especially true when a global supply chain is required which has many additional challenging issues. It's possible that once a new UTHR plant is up in a few years, it becomes the primary DPI supplier with the Danbury facility as emergency backup while it's primary function becomes producing other drugs such as Clofazimine TS. Some might suggest UTHR can now see the potential of TS and might prefer to go ahead and acquire Mannkind in total. This is doubtful for several reasons that include Mannkind seeing the potential even better and would wisely require an unacceptably high price. If another BP comes into the picture with a partnership and interest, this could get interesting to say the least. All IMO and wildly speculating what might be ahead. I think Martine has some decisions to make. I don't think anyone expected Tyvaso DPI to be such a success after afrezza was such a failure. I have not even heard of people complaining about the cough. I would think she needs to make some decisions soon. If MNKD is bought by another company that could create issues for UTHR. Who would have thought? Hopefully Mike is stirring the pot. |
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Post by anderson on Jan 23, 2023 16:46:56 GMT -5
Ron - what are your expectations from the additional manufacturing facility? " UT will have at least one other manufacturing facility." If I remember correctly the fill rate is 400 cartridges per minute which provides 24,000 per hour. Tyvaso DPI requires 4 cartridges per day per user or 52,000 per day for the 13,000 users. In theory the existing Danbury facility can provide all that is needed in 1/2 of the 1st shift. I think UTHR needs the facility for disaster recovery requirements. I believe sayhey24 is on the right track talking about cartridge fill rates. The dry powder is made in bulk batches, so manufacturing bulk material isn't the big problem, filling all those small cartridges is. So if you are thinking trade secret wise, keeping bulk powder manufacturing at Danbury makes sense and shipping the powder to finish fill lines somewhere else is fine. I think the original building had room for 12 lines(enough room for all USA AFrezza production) and only 2-3 were ever installed , and they have improved the fill rates over the years of the lines. |
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