I work in the healthcare field, with dialysis centers making up a small portion of my accounts. This informative article really hit home. This could be HUGE, not just from the financial perspective we on this platform are looking at, but for so many patients. Thank you for this info. Looking forward to part 2! 🙂
That is making valuation really hard on this, as its all based on the different scenarios. ( But i agree even if they just reach the BEAR case scenario, this is cheap). I wonder if there are any more risks involved not mentioned, as the medical business is kinda "hard". Its really good they already have contracts. I wonder how fast such products can be really deployed. When i look at Sanuwave or Covalon ( all different products, same idea/area) growth can really happen fast but sounds too "sure" :D i am always skeptical if things are too sure ^^
ALso one additional thing i want to point out. There are also citrate based solutions which are doing (almost) the same. So some sort of competition within there.
1- The deployment/rollout speed with the current TDAPA reimbursement in place. Essentially how much they can get at the price of $250 per vial. and the drop-off until the TDAPA add on ends. (This is hugely important to the upside).
2- The price they’re able to negotiate after. It’s highly highly unlikely it will be close to even $150 a vial because the currently kidney bundle per session is somewhere like $265 for everything. It would be crazy if Medicare was paying almost half the bundle rate for just one product. I think long-term it comes down a lot more, and this will form the basis of part 2.
"A new renal dialysis drug or biological product is included in the calculation of the post-TDAPA add-on payment adjustment for a period of 3 years. CMS annually calculates the post-TDAPA add-on payment adjustment for each quarter of the upcoming CY, based on the most recent 12 months of claims data. For drugs or biological products that lack a full year’s worth of utilization data when the annual final rule is developed, CMS will publish the post-TDAPA add-on payment adjustment amount in a CR once 12 months of utilization data are available (89 FR 89135 through 98136). The post-TDAPA add-on payment adjustment amount for a drug or biological product is the total expenditure for a new drug divided by total ESRD PPS expenditures during the same period, reduced by a case-mix standardization factor and a 65 percent risk-sharing factor and inflated by the market basket price proxy for pharmaceuticals."
Example
defenClath last 12 month revenue: $400M
Total ESRD PPS Expenditures: $ 20B
ESRD PPS bundle: 271$
Summary of the Calculation
Raw Ratio: $400M / $20B = 2.0%
After 65% Risk Sharing: 2.0% × 0.65 = 1.3%
After Case‑Mix Adjustment (–10%): 1.3% × 0.90 = 1.17%
After Market Basket Inflation (×1.03): 1.17% × 1.03 ≈ 1.21%
Add-on Amount : 271 × 0.0121 ≈ $ 3.28
I could not find anywhere direct 65% of WAC price from 3rd year. could you please clarify.
"...This new add-on payment adjustment will support Medicare ESRD beneficiaries’ continued access to new renal dialysis drugs and biological products. This payment adjustment will be case-mix adjusted and set at 65% of estimated expenditure levels for the given renal dialysis drug or biological product in the prior year. The post-TDAPA payment adjustment will be applied to all ESRD PPS payments for a period of three years..."
Quit question about the paid membership. Are there more picks available for the paid membership? Just wondering what is different than the free membership. Thanks.
Well done. Very detailed.
Written clearly and well-researched. Great find
Thanks mate pls give it a restack
I work in the healthcare field, with dialysis centers making up a small portion of my accounts. This informative article really hit home. This could be HUGE, not just from the financial perspective we on this platform are looking at, but for so many patients. Thank you for this info. Looking forward to part 2! 🙂
Thanks Tracy! Will be very valuable to get your insights on the thread I have started in the Subscriber Chat!
Great read so far, can’t wait for part II
Thank you!
Very exhaustive in-depth study by Archetype Capital. Keep it up.
Thanks man
love your conviction! hope you have a winner.
I hope so too. Part 2 will be a lot more nitty gritty detailed
That is making valuation really hard on this, as its all based on the different scenarios. ( But i agree even if they just reach the BEAR case scenario, this is cheap). I wonder if there are any more risks involved not mentioned, as the medical business is kinda "hard". Its really good they already have contracts. I wonder how fast such products can be really deployed. When i look at Sanuwave or Covalon ( all different products, same idea/area) growth can really happen fast but sounds too "sure" :D i am always skeptical if things are too sure ^^
ALso one additional thing i want to point out. There are also citrate based solutions which are doing (almost) the same. So some sort of competition within there.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6753535/
Thanks! I know they already use citrate but haven’t seen that they have been as effective. Will look deeper into this for part 2.
That would be great :) the upside lies in the speed of execution and deployment with current valuation .
You’re right. The upside lies in 2 factors only-
1- The deployment/rollout speed with the current TDAPA reimbursement in place. Essentially how much they can get at the price of $250 per vial. and the drop-off until the TDAPA add on ends. (This is hugely important to the upside).
2- The price they’re able to negotiate after. It’s highly highly unlikely it will be close to even $150 a vial because the currently kidney bundle per session is somewhere like $265 for everything. It would be crazy if Medicare was paying almost half the bundle rate for just one product. I think long-term it comes down a lot more, and this will form the basis of part 2.
Very well done!!!! Looking forward to part 2!
Almost done with it
Nice find. This has an extremely skewed payoff profile.
Thanks! Will buy stocks!!!!
Just seeing your account now via X. Planning to do a deep dive later today. Impressive picks!
could you please clarify add on payment from 3rd year.
This is mentioned in this link. https://www.cms.gov/medicare/payment/prospective-payment-systems/end-stage-renal-disease-esrd/esrd-pps-transitional-drug-add-payment-adjustment
"A new renal dialysis drug or biological product is included in the calculation of the post-TDAPA add-on payment adjustment for a period of 3 years. CMS annually calculates the post-TDAPA add-on payment adjustment for each quarter of the upcoming CY, based on the most recent 12 months of claims data. For drugs or biological products that lack a full year’s worth of utilization data when the annual final rule is developed, CMS will publish the post-TDAPA add-on payment adjustment amount in a CR once 12 months of utilization data are available (89 FR 89135 through 98136). The post-TDAPA add-on payment adjustment amount for a drug or biological product is the total expenditure for a new drug divided by total ESRD PPS expenditures during the same period, reduced by a case-mix standardization factor and a 65 percent risk-sharing factor and inflated by the market basket price proxy for pharmaceuticals."
Example
defenClath last 12 month revenue: $400M
Total ESRD PPS Expenditures: $ 20B
ESRD PPS bundle: 271$
Summary of the Calculation
Raw Ratio: $400M / $20B = 2.0%
After 65% Risk Sharing: 2.0% × 0.65 = 1.3%
After Case‑Mix Adjustment (–10%): 1.3% × 0.90 = 1.17%
After Market Basket Inflation (×1.03): 1.17% × 1.03 ≈ 1.21%
Add-on Amount : 271 × 0.0121 ≈ $ 3.28
I could not find anywhere direct 65% of WAC price from 3rd year. could you please clarify.
See here from latest CMS rule: https://www.cms.gov/newsroom/fact-sheets/calendar-year-2024-end-stage-renal-disease-esrd-prospective-payment-system-pps-final-rule-cms-1782-f?utm_source=chatgpt.com
"...This new add-on payment adjustment will support Medicare ESRD beneficiaries’ continued access to new renal dialysis drugs and biological products. This payment adjustment will be case-mix adjusted and set at 65% of estimated expenditure levels for the given renal dialysis drug or biological product in the prior year. The post-TDAPA payment adjustment will be applied to all ESRD PPS payments for a period of three years..."
why did this show up in my email , AFTER it lifted 10% on the day
Yeah sorry man. I tried to get it out soon. But to be honest with you I’m expecting this thing to do 60% fluctuations either side
Thank you very much 🙏
Quit question about the paid membership. Are there more picks available for the paid membership? Just wondering what is different than the free membership. Thanks.
I haven't gone paid yet.
When you look it gives and option for paid. Also new to substack and find it a bit of a maze so I could be wrong.
I haven’t set it up yet, so not sure
Amazing write up! Very clear and looking forward to part 2.