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- Cormedix (CRMD) is a biotech company that primarily focuses on the prevention of Catheter Related Blood infections with their leading product, Defencath. Catheter Related Blood Infections plagues the End Stage Disease Population. According to the National Institute of Diabetes and Digestive and Kidney Disease Institute, nearly 808,000 people suffer from this ailment, and approximately 69% are on dialysis(https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease#:~:text=Nearly%20808%2C000%20people%20in%20the,31%25%20with%20a%20kidney%20transplant.))
- Defencath is a catheter lock solution that eliminates both gram positive and gram negative bacterial infections that develop within the Catheter. Defencath is composed of a solution of taurolidine and heparin that effectively reduces the CRBSI events in this vulnerable population.
However, this population has a catheter that is surgically implanted into their patient and its called a, “Central Venous Catheter.” This type of catheter is placed near a large center vein most commonly an internal jugular or subclavian. In layman terms, it’s placed near the patient's heart, implanted on the patient to administer medication or to administer hemo-dialysis. * The results of their Lock-100 Study had 71% reduction in CRBIS compared to the control (https://pubmed.ncbi.nlm.nih.gov/37678222/). Additionally, They rejected the null hypothesis by a P value of .0006 to such a degree that it would only occur in 1 in 10,000 tries due to sheer random chance. Therefore, the phase III study was halted. * There are approximately 250,000k CRBIS events per year according to this site,(https://www.sciencedirect.com/topics/nursing-and-health-professions/catheter-infection#:\~:text=Catheter%2Drelated%20infections%20remain%20among%20the%20top%20three,catheter%2Drelated%20infections%20is%20approximately%2014%%2C%20and%2019)
You can check the company’s most recent deck to see the potential impact of Defencath on CRBIS here, (https://cormedix.com/wp-content/uploads/2023/03/CorMedix-Corp-Presentation_1-7-23.pdf) * As of November 15, 2023 Cormedix received a NDA Approval by the FDA for the limited population of Adult patients affected by kidney failure( https://cormedix.com/cormedix-inc-announces-fda-approval-of-defencath-to-reduce-the-incidence-of-catheter-related-bloodstream-infections-in-adult-hemodialysis-patients/#:~:text=About%20CorMedix&text=DefenCath%20has%20been%20designated%20by,address%20an%20unmet%20medical%20need.)) * As of January 30, and April 9th 2024, Cormedix secured CMS J-Codes for In-Patient and Outpatient settings.( https://cormedix.com/cormedix-inc-announces-commercial-and-reimbursement-updates/) and (https://cormedix.com/cormedix-inc-announces-commercial-agreement-with-arc-dialysis-llc/) * On April 19, 2024, Cormedix Also Secured TDAPA reimbursement from CMS for the Out-Patient Setting(https://cormedix.com/cormedix-inc-announces-cms-grants-tdapa-to-defencath/).
Lastly: on April 15, 2024, Cormedix Celebrated their commercial launch for the in-patient setting, and expect to lauch out-patient by July 1st 2024. ( https://www.globenewswire.com/news-...ity-of-DefenCath-Taurolidine-and-Heparin.html) * Why is Cormedix a Deep Value Opportunity to add to your portfolio today? As of Close on 4/23/24 the stock was trading at $5.45 CEO, Joe Todisco Currently owns 352,000 shares, and added to his position by approximately 13,561 on March 13, 2024 at $3.74 per share. Additionally, other insiders have not sold any shares over the past few years. I heavily weigh insider ownership whether they were paid for, awarded, or granted in lieu of payment. You can see all insider activity here, (https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity). * The institutional ownership acquired about 33.94% of total shares on the open market with Black Rock Inc leading with 3,507,695 Shares held as of 12/31/23. Numora Holding Inc, comes in second at 2,946, 552 shares, then Vanguard at 2,825,335 million shares, and lastly Elliot Investment Management L.P., comes in at 1,550, 523 million shares. See all institutional ownership here, (https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings) * You’re probably wondering at this point, how does Defencath work, and what are the Projected vials to be sold? Cormedix projects to sell 3.4 million vials on the inpatient side and over 37 million vials on the out-patient side. The growth potential is HUGE!
With such volume you’re probably wondering at this point how precisely does the product work… Well, Every Time a patient receives hemo-dialysis the catheter must be flushed with the Defencath solution before and after. That is approximately two vials per patient per visit with the average patient getting about 3 treatments per-week, out of 550,000 patients on hemodialysis. * Cormedix plans, and is on track to launch Defencath for out-patient setting on July 1, 2024.
Cormedix Plans on expanding its usage and application of Defencath to other populations that already have CVCs, like Oncology. * The current short interest as of 3/31/24 is 34 million dollars or approx. 8.2 million shares.
Marketing Plan: There are 5 major companies that control the out-patient setting, and two of them control 70% of the market. Remember, Out-patient is projected to sell appx. 37 million vials!
The Projected market impact of the stock is incredible, and understanding the product shows the extreme value it holds. * Debt: the company has NO debt. * Market Exclusivity: CRMD has 10.5 years market exclusivity because it's a qualified infectious diseases, and it's a new chemical entity. And it’s intellectual property is extended until April 15, 2024. See (https://cormedix.com/cormedix-inc-announces-issuance-of-u-s-patent-covering-lead-product-defencath/) * WHY WILL CRMD EXPLODE SOONER THAN ANALYISTS EXPECTATIONS? * The out-patient setting is dominated by 5 major out-patient facilities, and once it received it's NDA every medical Journal posted the NDA approval AND JOE, MENTIONED THEY WERE ALREADY TALKING TO BOTH IN-PATIENT AND OUT PATIENT FACILITIES AT March 12th Earnings Call "March 12, 2024 "Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we have scaled up activity ahead of our commercial launch in April. We have received significant inbound interest from both inpatient facilities as well as outpatient dialysis providers with respect to DefenCath, and we are actively engaged in customer discussions in both settings of care" (https://cormedix.com/cormedix-inc-reports-fourth-quarter-and-full-year-2023-financial-results-and-provides-business-update/#:~:text=Conference%20Call%20Scheduled%20for%20Today,%C2%AE%20(taurolidine%20and%20heparin))) * Competition: There is no Drug on the market that prevents CRBIs the way Cormedix does and there is absolutely no competition. * The CTXR guys will say we’re competition but we’re not. Mino-lock salvages an already infected Catheter. It’s a reactive medicine opposed to Defencath which is Preventative.
The preventative application allows for such high sales values in such an exclusive market.
- CREDIT TO Fretwizard125, “Good post and summary of what’s in play here. I’ve been in CRMD since 2018 and Have been accumulating. Have a multi-hundred thousand dollar position and am waiting for this to explode. With TDAPA we could see 70-80% market penetration really quickly, (1-2 years).
The Wholesale Acquisition Price FROM CRMD and approved by CMS is $250/vial. They will likely offer discounts to the providers to adopt and recognize revenue too. But even with a 70% discount for a vial potential revenue is insane. * Quick math $75/vial x20,000,000 vials (50% penetration) =$1.5b. Yes billion, with a B.
This does not include other indications they are trying to expand into including oncology and TPN. Oncology market is 1.5x the size of hemodialysis. This is a long term hold with literally the most perfect commercialization setup I’ve ever seen.”--- Credit to Fretwizard 125 * Projected Price: Low $9.00 per share, medium is $12.00 per share; high of $19.00 per share within the next year. I believe we’re going to hit the 9s in july and potentially hit 20s before December. * TLRD: Cormedix(CRMD) Is Deep Value. It hit’s all of the marks. CRMD is poised for huge growth over the next year, reaching over a billion sales. The market is unique, and they’re going to be the standard of care. The stock is primed to explode at any day. I believe the stock will be at least 25$ per share by March 2025 if not $35-$40 per share. 5 Major companies control 100% of the out-patient market. They’ll be announcing contracts in the coming weeks. I think we can hit 12$ before the out-patient launch in July, that’s my opinion. * All RISK IS ELIMINATED!
* POSITION: * 50 call contracts $6 strike, .10 cents per share, 10$ per K Exp. June 21 * 50 call Contracts $7 strike, .10 cents per share, 10$ per K exp June 21 * 3750 Shares average $4.15. (have a little bit of higher average because of options trading throughout the past 3 years.)
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