**A)You guys didn't like my last regarded post so here's my DD; and**
**(B)The following is my opinion, and is NOT investment advice**.
**TLDR:** I believe CorMedix will be $25-$50 by EOY… Mark my regardation... Enjoy.
**Summary:** CorMedix ran 214% since August 2024. I believe CRMD will run to $25-$50 before year end. However, I could not post it prior to its previous run due to WSB’s post requirements. I cited as much as I could to be: (a) transparent; and (b) illustrate my thought process. (Obviously, the price point and projection is my opinion based on the available data.)
**Position:**
https://preview.redd.it/f1s8mqj5scde1.jpg?width=1290&format=pjpg&auto=webp&s=6e0f9ab4c64a58d73a3d6864bbe658c04c4e9ba2
**NOTE**\*\*:\*\* “Id.” means the same document or page if without a corresponding page number. All Ids. should be referencing the prior source i.e., non-interchanging. If not then it is a mistake, and use your best judgement in reviewing all the sources...Lastly, some sources you're going to have to look up yourself, i.e., 2024 Q3 Earnings transcripts/calls.
Cormedix is a biotech company that has an FDA approved product called Defencath.(See Investor Deck Page 3[ https://cormedix.com/wp-content/uploads/2024/11/CorMedix-Corp-Presentation\_11-7-24.pdf](https://cormedix.com/wp-content/uploads/2024/11/CorMedix-Corp-Presentation_11-7-24.pdf)) Defencath is a catheter lock solution that prevents Catheter Related Blood Infections (CRBIS) for people who are receiving Hemodialysis(HD) as a result of kidney failure. (Id. at page 3.) Defencath reduces incident rates of CRBISs by 71% and an efficacy rate of .00006.(See [https://www.defencath.com/safety](https://www.defencath.com/safety)). Approximately 170,000 patients that are on (HD) have CVCs.(Id. at page 17.) The total addressable market for Defencath is between 37 million to 46 million in the out-patient setting. (Id. at 17). The total addressable market on the in-patient side is approximately 3.8 million vials (Id. at 15).
A Central Venous Catheter (CVC) is surgically implanted in a patient so they can receive HD. The HD session allows the blood to exit the body, and enter a dialysis machine to filter out the waste. Think of a dialysis machine as an artificial kidney. The blood must travel through the CVC in order for it to eliminate waste from a patient's blood. This population, as a result of having a CVC, is susceptible to CRBISs composed of: (1) gram positive bacteria; (2) gram negative bacteria; and (3) fungal infections; that grow within the CVC. (See video:[ https://www.defencath.com/how-defencath-works](https://www.defencath.com/how-defencath-works)) Therefore, Defencath cleans the CVC to prevent these infections before and after HD sessions.
**For the Clearguard Brigade:** as the Clearguard caps are only 61% effective after 3 months–as opposed to Cormedix’s post marketing study from EU, where **DEFENCATH reduced CRBISs by 96%: “Under the study, 202 hemodialysis patients at 20 hemodialysis centers in Germany were enrolled in the ongoing Neutrolin Use Monitoring Program (NUMP), representing 15,464 dialysis sessions over a 26-month period, for a total of 36,083 hemodialysis catheter days. These data demonstrated that use of Neutrolin is associated with 96.0% reduction in the rate of CRBSI and 96.7% reduction in thrombosis compared to published historical benchmarks of 3.5 CRBSIs and 2-3 episodes of thrombosis per 1,000 catheter days.” (See** [**https://cormedix.com/defencath/neutrolin-in-europe/**](https://cormedix.com/defencath/neutrolin-in-europe/)**)** Reminder–Neutroline was Defencath’s name prior to it being changed in the states. Obviously, it was not an FDA post-marketing study, but it is a hint to how it will preform on its' post marketing study, in the U.S.. (I believe the above is the correct interpretation, feel free to doublecheck me.)
Since the HD population typically receives treatments three (3x) times a week, and two vials are required per each session to prevent CRBIS. This is why the total addressable market, when fully implemented, is projected to sell between 37 million and 47 million vials per year. (see investor deck).
Cormedix secured 60% of the out-patient centers, and the top 5 companies control 85% of the market. Cormedix already has contracts with the four (4) of the five (5) top market participants as well as smaller providers. (See 2024 Q3 Earnings call.... quoting("We recently announced new agreements with two midsized dialysis operators and one large-scale operator, which combined with our existing customers will provide patients access to DefenCath at roughly 60% of dialysis clinics in the U.S. We are currently working diligently with our new partners to operationalize those agreements and currently expect purchases to commence for all three before the end of the fourth quarter.")).
In Q3 of 2024 CRMD earned 11.5 million. **However**, in Q4 of 2024, CRMD beat estimates by securing **$31 million, and is reported to have 25 million in** ***open*** **orders in Q1 of 2025.** (See[ https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/](https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/)). The following link illustrates what some postulated what CorMedix’s growth would look like prior to its most recent announcement. (See [https://media.stocktwits-cdn.com/api/3/media/182924/default.png](https://media.stocktwits-cdn.com/api/3/media/182924/default.png); Credit to Newageinvestor)
**Insiders** have been holding for years, except for one who recently sold in November of 2024, however, she was awarded nearly the same amount of shares in Q1 of 2025. And some insiders sold some shares for tax purposes. (See all insider activity:[ https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity](https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity); see also SEC Filings)
**Institutional holdings** amount to approximately 31% with the top holders listed in descending order: (1) Blackrock, 3.6 million shares; (2) Vanguard Group, 3 million shares; (3) Elliot Management, with approximately 1.5 million shares; (4) Rosalind Advisors with 1.4 million shares; (5) Geode Capital with 1.2 Million shares; and (6) State Street Corp with 1.2 Million shares. (see[ https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings](https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings))
**Short Interest** is currently at 11.45% or approximately 7 million shares. (See[ https://www.marketbeat.com/stocks/NASDAQ/CRMD/short-interest/](https://www.marketbeat.com/stocks/NASDAQ/CRMD/short-interest/))
**Key Statistics**: (1) 60 million shares; (2) cash in hand 53 million; (3) **zero debt**; and (4) a market cap of 650 million. (See investor Deck)
**Q-10 10/30/24:**
On April 18, 2024 CorMedix Transitional Drug Add-on-Payment (TDAPA) was granted by CMS for ESRD patients which provides temporary additional payments for certain new drugs. The TDAPA’s reimbursement is calculated on 100% of the WAC. (See page 22 of 10-Q CorMedix 10/30/24, quoting(“The HCPCS J-code for DefenCath was published by CMS on April 2, 2024. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or manufacturers’ list price, respectively, if such data is unavailable). TDAPA and post-TDAPA add-on payment adjustments for DefenCath apply for five years (with such add-on payments applying to all ESRD PPS payments for years three through five). CMS confirmed a July 1, 2024 implementation date for HCPCS and TDAPA.”)).
April 26, 2023 Cormedix was granted a New Technology Add-On Payment(NTAP) which reimburses in-patient facilities of 75% of the WAC per 3 mL vial. The average hospital stay is approximately 19.5 vials per hospital stay. The WAC price is 249.99 per 3 mL vial. (See page 22 of 10-Q CorMedix 10/30/24)
On June 6, 2024, Cormedix announced medicare via its hospital out-patient system granted Defencath a “pass-through status.” Medicare basically pays separately for Defencath when it is used in outpatient settings rather than bundling it with other payments. The company estimates 100,000 CVC placements for HD patients that occurs annually. This pass-through status allows out-patient providers to be reimbursed as a result. This pass through payment status is at minimum 2 years and at max three years. (Id. at 22)
In June of 2024 CRMD received feedback from FDA for expansion for other indications for Defencath, and three (3) clinical protocols were discussed: (1) a post-marketing requirement for pediatric HD to ensure efficacy; (2) Phase 3 TPN study for adult TPN patients; and (3) EAP to allow patients access to Defencath prior to approval for those with CVCs.(Id. At 23). The TPN & Pediatric HD study are projected to begin in 2025.(Id.)
Patent protection for Defencath is until 2042 (Id at 23.)
**Key points for TDAPA**
* TDAPA commenced on July 1st and applies to all Medicare fee-for-service patients, which comprises roughly 45% of all ESRD patients in the United States. Medicare Advantage, comprising an additional 45% of ESRD patients, remains an opportunity for growth and expansion for the DefenCath reimbursement. We have been engaged with all major Medicare Advantage organizations across the country, and we are happy to report that UnitedHealthcare, the largest MA plan in the country in terms of covered lives, which accounts for roughly 30% of Medicare Advantage enrollment, has confirmed that they will provide comparable TDAPA reimbursement for DefenCath beginning on September 1st.
* Humana, which comprises roughly 20% of Medicare Advantage population, has also confirmed that they will provide TDAPA reimbursement, which may vary, depending on provider contracts. As we progress through our first year of launch, the company intends to remain engaged with Medicare Advantage plans to ensure adequate reimbursement to operators.
* From a long-term perspective, the company believes that ESRD Medicare patients, in general, will -- that -- will continue to migrate from Medicare fee-for-service into Medicare Advantage plans and that the value-based care proposition for DefenCath will resonate with MA plans and hopefully result in long-term sustainable separate reimbursement in this patient segment.
* See[ ](https://www.fool.com/earnings/call-transcripts/2024/08/14/cormedix-crmd-q2-2024-earnings-call-transcript/)Earnings transcripts Q3 and and Q4 Press release.
**Additional stuff WSB Probably won’t read LOL:**
1. **TOTAL PARENTERAL NUTRITION –Label expansion:**
1. The Company believes that a TPN Roll out in 2027 to 2028 would increase revenue by 150 million dollars. See earnings transcripts Q3 and Q4 press release--Google)
**Ongoing clinical trials & costs**
1. Pediatric Clinical Trials are planned to begin in the second half of 2025 in conjunction with TPN for the first half of 2025. (See [ https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/?utm\_source=chatgpt.com](https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/?utm_source=chatgpt.com))
2. TPN Clinical protocol was submitted in Q4 of 2024.
3. Cormedix is enrolling 4,000 patients with LDO (Likely Fresenius) in the first half of 2025.
4. Real World study with US Renal Care:
5. Expected cost of operations for 2025 is between 72-million and 78 million. ([https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/?utm\_source=chatgpt.com](https://cormedix.com/cormedix-inc-announces-preliminary-fourth-quarter-2024-results-and-provides-business-update/?utm_source=chatgpt.com))
6. **Fresenius stake:**
1. Elliot Investment has acquired a significant stake in FMC & CorMedix.
2. Erin Misty has close ties to Elliot Management & Syneos Health which is likely the reason for the recent layoffs in the sales team. (See CorMedix's Website-)
*I'm actually shocked, had you read this far in....*
**NOTE: This is what I think could happen for Q1 of 2025 and it is only my belief/opinion ... I'm Regarded:** I believe the company will earn anywhere from 51 million to 71 million for Q1 of 2025. This takes into account the following factors: (1) 2000 of 4000Fresenius patients (which is 10% of their CVC patients), and (2) it assumes we correctly did the math for 31 million Q4's 2024; (3) additional patients are receiving Defencath as a treatment as part of the "ramp up." ... I'm sure there are smarter people than me out here who can double check everything...
**TLDR: This is my opinion, and it is not in anyway investment advice.** I believe CorMedix will be $25-$50 by EOY… Mark my (regarded) words... Enjoy.
**Summary:** CorMedix ran 214% since August 2024. I believe CRMD will run to $25-$50 before year end. However, I could not post it prior to its previous run due to WSB’s post requirements. Every statement made herein, is supported by verifiable facts, about the company has a citation. I’ve also linked previous reddit posts done by others. (Obviously, the price point and projection is my opinion based on the available data.)