CorMedix 2.0: New Leadership, New Approval, New Focus

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CorMedix is a biopharmaceutical company that has undergone a re-birth as it enters a new phase with FDA approval of its anti-infective catheter solution, DefenCath.The company has faced challenges in ...

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You can become one too! Share your best investment idea by submitting your article for review to our editors. Get published, earn money, and unlock exclusive SA Premium access. Click here to find out more »    Wildroze Thesis CorMedix (NASDAQ:CRMD) is a small-cap biopharmaceutical company bringing DefenCath, an anti-infective catheter lock solution, to market in the US. The company is not new but rather old. The company is having a re-birth experience in 2024 as it delivers with new executive leadership, focus beyond FDA approval for DefenCath, and transforming from a biotech to a commercial stage biopharma company. The recent stock rise has helped it grab significant investor and media attention.  In this article, I recap the troubled history of CorMedix, how tides have changed since last year, and how a valuation assessment of the company shows it is undervalued at present even after a significant run-up. The Old Brief Timelines In January 2015, CorMedix initially qualified DefenCath (then called Neutrolin) as a Qualified Infectious Disease Product (QIDP) for prevention of catheter-related blood stream infections (CRBSIs) with the FDA. In December 2015, they launched a phase 3 clinical trial (LOCK-IT-100) with 795 patients using catheters for hemodialysis in the United States. By January 2019, they announced topline results (see Figure 1) which blew away the primary endpoint, showing a statistically significant 72% reduction in the risk of CRBSI occurrence compared with the active control arm of heparin only (standard of care). Then in August 2020, the FDA accepted the DefenCath NDA filing with a priority review period of 6-months instead of the standard 10-month review period.   Figure 1: Phase 3 LOCK-IT-100 Primary Endpoint Results (Cormedix Website) Value Proposition DefenCath is a new solution for a relatively old market. Catheters are commonplace medical devices in hospital and dialysis settings. However, a persistent issue has been CRBSIs. Unfortunately, heparin-only catheter lock solutions have not prevented all CRBSIs from occurring. DefenCath brought a much-needed refresh to CRBSI infection prevention with its unique and patented blend of taurolidine, heparin, and citrate. The incidence of CRBSI reported varies; however, meta-analytical study done at The Johns Hopkins University showed that bloodstream infections were the third leading cause of hospital-acquired infections. These infections have an attributable mortality rate of 12% to 25% and marginal cost to the health-care system of $25,000-$63,000 per episode. DefenCath brought much promise to reduce significant costs imposed on hospitals and dialysis center for treating patients with CRBSIs and, more importantly, save lives. Old Leadership At the helm for most of this period were two significant senior executives for the company. The first was President & CEO, Khoso Baluch, who joined the company in October 2016. The second was Dr. Phoebe Mounts, who had been a trusted legal advisor for CorMedix since 2013 and then joined full-time as Executive Vice President and General Counsel in May 2019.  Stock Price History CorMedix stock went through the typical roller coaster cycles of a pre-commercial biotech during that time period (see Figure 2). It saw highs of $18 in February 2021 during the pandemic lockdown as it almost received FDA approval, and lows of $1 in April 2018 before the LOCK-IT-100 study results released. These prices factor in a one-for-five reverse split the company issued in March 2019.   Figure 2: CRMD Stock Price from 2018-2023 (Seeking Alpha) The CRL Setbacks The enthusiasm for DefenCath was as palpable back in 2021 as it is now. The solution has a near monopoly until 2042 when DefenCath patent coverage expires since there are no other catheter lock solutions in development (only competing against heparin), and is likely to replace heparin as the new standard of care. The company was on the verge of receiving FDA approval when it suffered a severe setback with its first CRL in March 2021. The news cratered the stock price from a high of $18 down to a sub-$5 range six months later in September 2021. Mr. Baluch consequently resigned in October 2021 and CFO Matt David stepped in as interim CEO. By February 2022, the company resubmitted the NDA and was granted a class 2 response by FDA with a 6-month review cycle. Reserved excitement filled the investor base as the stock reached $7 in August 2022 in anticipation of FDA approval. But then news of a second CRL was given by FDA, and it killed all excitement. FDA reiterated unresolved manufacturing issues and added a new concern with the supplier of the active pharmaceutical ingredient (API) heparin. The share price was sent lower than $3 in the midst of an industry-wide biotech slump.  The New New Leadership The seeds of change were planted in May 2022 when Joe Todisco was hired as the new CEO. Joe's background in commercialization with three other biotech companies showed the company fully intended to bring DefenCath to market with renewed leadership. Beyond that, the tone of the quarterly calls changed as Mr. Todisco brought much needed rigor to the regulatory approval process and go-to-market plans. Mr. Todisco brought onboard backup manufacturers and heparin suppliers as contingency plans, so a third CRL would not happen. He also formed strategic partnerships prior to FDA approval, beginning with a partnership with Boston Medical Center in June 2023, and accelerated discussions with FDA on Medicare & Medicaid reimbursements for DefenCath. New Approval Then on November 15th, 2023, the company and its shareholders received the news it had been waiting for almost three years. DefenCath was approved by the FDA for use in hemodialysis patients. The drug received three unique designations, including 1) QIDP, 2) New Molecular Entity (NME), and 3) Limited Population pathway for Antibacterial and Antifungal drugs (LPAD) designation. Each with its own unique benefits, including a combined 10-years of extended market exclusivity and potential for follow-on indications like oncology to be approved with smaller and faster clinical trials. The momentous decision did nothing to the stock price as investor burnout with the company lingered, but it marked a new chapter in CorMedix history. A new company had been born, and immediately the focus shifted beyond the FDA to outpatient and inpatient settings for its newly approved product. The company would no longer be a biotech company but a biopharma company in pursuit of top-line growth. New Focus The death of the old development-stage biotech company and birth of the new commercial biopharma company was decisively marked with the departure of Dr. Mounts from the executive team in December 2023. Dr. Mounts played a critical role in bringing DefenCath across the regulatory finish line. However, her departure signaled that regulatory expertise was no longer essential for the company's success and the company was entering a new era requiring commercial expertise. This is exactly where Mr. Todisco steps into the picture. He brings the new lingua franca to the company around reimbursements, formulary wins, and coverage; no longer about net operating losses (NOLs), warrants, and resubmissions. Mr. Todisco's plan for 2024 demonstrates the company is springing in to action, and they are already delivering on the new narrative. The plan's three main takeaways include: 1a) Market demand from both inpatient and outpatient settings 1b) Market demand with and without reimbursement coverage 2a) Commercial launch for the inpatient and outpatient settings in 2024 2b) Accelerated staffing to rapidly reach both inpatient & outpatient customers 3) Sufficient cash to launch commercially and reach profitability by year-end Valuation CorMedix transformation into a commercial-stage biopharma should also reflect in the company's share price and market capitalization. As of October 2024, the company's market capitalization is near $720 million with roughly 55M shares outstanding, no debt, and the share price trading around $13.00. The accumulated deficit since inception is over $350 million. The question is, does this valuation make sense given the company's commercialization progress and prospects? Using the discount cash flow and peak sales multiple valuation methods, I argue it does not make sense. Let's start by looking at the total addressable market (TAM) for DefenCath in hemodialysis only. Outpatient TAM   Figure 3: DefenCath TAM (Cormedix Corporate Presentation) For outpatient settings, the company estimates 37-46 million vials per year (see Figure 3). A typical vial of high concentration heparin (5000 units/mL) costs around between $3.20 per mL in wholesale pricing. Heparin is the standard of care for catheter lock solutions and also one of two key APIs in DefenCath. Therefore, it's reasonable to assume that DefenCath will be priced at least 50-100% higher. That would make a 3mL vial of DefenCath price around $15-20 wholesale. 40 million vials per year x $20 per 3mL vial = $800 million per year TAM Inpatient TAM For inpatient settings, the company estimates 1.1 million vials per year for hospitalizations in end-stage renal disease (ESRD) and 2.7 million vials per year for acute kidney injury (AKI) (see Figure 3). That makes a total of 3.8M per year for all inpatient settings. Estimating pricing is more challenging because the Centers for Medicare and Medicaid Services (CMS) reimburses hospitals, who then pay their drug suppliers. This is a somewhat opaque system and process. The CMS has agreed to reimburse hospitals using DefenCath up to five years under the Transitional Drug Add-on Payment Adjustment (TDAPA). It includes two years of add-on payments based on average sales price or wholesale acquisition cost (WAC) from July 1, 2024 to June 30, 2026. The ASP is not published, and the WAC is currently $249.99/vial. Then after the initial two years, ESRD facilities that administer DefenCath will receive payment under the ESRD Prospective Payment System (PPS) for three additional years after TDAPA ends. After the five-year financial incentive for hospitals to pilot DefenCath, there is no additional add-on payment and anticipate lower ASPs. The inpatient TAM is calculated by taking a weighted average of the TDAPA reimbursed sale price per 3mL vial of DefenCath for the first five years and the non-reimbursed sale price for the remaining years. The first five years also must account for declining ASP and CMS reimbursement (see Figure 4). Figure 4: Inpatient TDAPA Reimbursement Schedule (Cormedix Corporate Presentation) Assuming hospitals use the product for 10 years, ASP declines linearly from $250 to $200 over years 0-2, remains constant over years 2-5, and then declines linearly from $200 to $20 from years 5-10 (same price as outpatient setting), then we get: (0.5 x $250 + 1.5 x $225 + 3 x $200 + 5 x $40) / 10 = $126 weighted average ASP for inpatient settings Unfortunately, there are not many studies available on the revenue split between hospitals and drug suppliers. One study found that hospitals keep ~60% of the reimbursement and only share ~40% of the revenue with drug suppliers (see Figure 5). This study looked at commercial-funded outpatient settings only. Figure 5: Estimated Revenue Split Between Hospitals & Drug Suppliers (Partnership for Health Analytic Research) Another study looked at both commercial and Medicare-funded outpatient and inpatient settings (see Figure 6). Looking at the chart, we can see there is not a large difference between the spending for commercial physician-administered drugs and Medicare physician-administered drugs (see dotted green & blue lines). Therefore, we can reasonably assume that the 60/40 split also applies to the Medicare-funded inpatient settings. Figure 6: Commercial- & Medicare-Funded Spending for Outpatient & Inpatient Settings from 2015-2017 (Deloitte) 3.8 million vials per year x $126 per 3mL vial x 40% revenue share with drug supplier = $192 million per year TAM Total TAM Summing both outpatient and inpatient settings for DefenCath in hemodialysis settings, we arrive at a total TAM of ~$1 billion per year. Notably, this market is exclusive to CorMedix for 10 years thanks to the QIDP and LPAD designations. Revenue Growth Assumptions The dynamics of market penetration will vary for both hemodialysis settings. The outpatient setting has five dialysis organizations treating up 85% of the patients. Winning those accounts means fast outpatient market penetration. That's exactly what the CorMedix team have done with up to 60% of outpatient facilities in the US secured under contract to date.  Meanwhile, the inpatient setting has 20% of the hospitals treating 75% of patients. Nonetheless, with 6,100 hospitals in the US that means 1,220 hospitals are responsible for the majority of the patients. That will take time for the CorMedix account team to penetrate the inpatient market. In both outpatient and inpatient settings, favorable reimbursements from CMS will accelerate adoption considerably. Other Assumptions  Free cash flow (FCF) margin growing from 0% to 30% over 5-years, based off the FCF margin range across the 17 largest global pharmaceutical companies (the average is 19%, JNJ and PFE have 5-yr averages at 24%) FCF ramping up slowly, assuming the business will self-fund entirely in 2025 and retain increasingly more cash flow each year after 16% WACC given a 2-yr Beta of 2.0, equity risk premium of 6%, risk-free rate of 4%, no debt and only equity financing in the capital structure 1% perpetuity growth rate (for terminal value) Peak sales multiple (PSM) of 5x (for terminal value) 5 million shares more dilution for extra cash, then unchanging 60 million total shares Faster market penetration for outpatient settings Unchanging outpatient ASP of $20/vial Unchanging outpatient TAM 2-year ramp time for outpatient settings to use DefenCath 100% Slower market penetration for inpatient settings Unchanging inpatient TAM No catheter lock solution competition for 10-years ~100% TAM capture in 10-years across outpatient and inpatient settings due to potential liability of not using DefenCath in CRBSI prevention  Valuation & Share Price Calculation Figure 7: Cormedix Valuation for Hemodialysis Only Looking at Figure 7 above, we calculate the net present value of CorMedix enterprise value to be around $1.1-1.2 billion from peak sales and DCF valuations. Assuming no debt, the enterprise valuation is the market capitalization, so the corresponding share price at 60 million shares outstanding is $19. We see that CorMedix is undervalued given the current market price of $13.  The cash runway for CorMedix after Q2 2024 was around $46 million. The cash burn rate was $15 million for SG&A and $1 million for R&D, totaling about $16 million. Below is the forward-looking cash burn guidance from CFO, Matt David: \"As we have discussed previously, we expect our operating expenses, especially sales and marketing and G&A to remain at the current levels, given the growth of the company and the cost driven by the commercial launch of DefenCath. CorMedix continues to expect 2024 quarterly operating expenses to range from around $15 million to $18 million to support commercial infrastructure and the ongoing launch of DefenCath.\" Importantly, both Matt and Joe commented in the Q2 earnings call that they believe CorMedix will hit profitability by the end of 2024: Matt David: \"We believe our cash, cash equivalents, short-term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months, and to fund the commercial launch of DefenCath through to breakeven EBITDA, which may occur on a run rate basis by the end of 2024, assuming we maintain our current growth trajectory of sales from existing key outpatient accounts as well as achieve forecasted shipments to new accounts by the beginning of fourth quarter.\" Joe Todisco: \"I think that breakeven EBITDA is certainly achievable before the end of the year.\" Given the company will end 2024 with somewhere near $15 million in cash, I anticipate they will sell some shares. Therefore, I've modeled 5 million shares sold on the market. Assuming $12-15 stock price, the company will net an additional $60-75 million in cash. That would send CorMedix into 2025 with a healthy balance sheet, no debt, and profitability to self-fund the business going forward.  If Mr. Todisco and the CorMedix leadership team can execute the commercial plan effectively, there is room for significant share price appreciation beyond the current $13 share price. This is taking into account a 10-year time horizon with which CorMedix has exclusivity in the hemodialysis market. Other Indications - TAM & Valuation Expansion Importantly, DefenCath can treat additional market indications, including oncology and total parenteral nutrition (TPN). The company estimates that oncology with a potential TAM of 136M vials per year. Meanwhile, TPN with a potential TAM of 14M vials per year. A catheter is a catheter. It is not a stretch for the company to enter these indications with ease by potentially leveraging the LPAD designation. The company has already started dialogues with the FDA on clinical studies to enter the TPN indication. Should CorMedix successfully enter these markets, it will add significant upside to the $19/share valuation. For simplicity’ sake, I limited the valuation to the hemodialysis market only. However, one could reasonably add risk-adjusted valuations for both additional indications. Risks There are two areas of risk to this thesis: macroeconomic and commercial risk. 1) Macroeconomic Risk It is important to note that the TAM for inpatient settings is highly dependent on the CMS reimbursement and also revenue split from hospitals. Should the government shutdown because of US government debt ceiling tensions or unsustainable deficit spending, it may significantly impact CMS reimbursements for DefenCath. Likewise, if Congress decides to reduce spending for Medicare and Medicaid programs, that may also impact CMS reimbursements for DefenCath if the program funding is curtailed. Also, if the hospitals keep more than 60% of the reimbursement profit, then the profit to CorMedix is reduced. The same risk also applies to the outpatient setting to a lesser degree. The company's CMS J-code reimbursement for outpatient settings provides dialysis providers an important incentive to adopt DefenCath; it provides an extra add-on payment for use of DefenCath in outpatient settings. Should the US government curtail funding for CMS, it would reduce the rate of adoption, as the economic model and value proposition would rely only on the cost savings provided to the dialysis provider. Any reduction in outpatient setting revenues would take a significant hit on CorMedix valuation, given the 4:1 TAM ratio of outpatient to inpatient market size. 2) Commercial Risk Key risks include the account team not winning formularies quickly and not signing all the largest US dialysis providers. Any slips in the commercial execution plan will push out the revenue and therefore share price expectations. Although the company has made progress with the outpatient providers, they are still notably missing one of the two largest dialysis providers in the US (either DaVita or Fresenius). Not signing both the largest dialysis providers would be a negative signal to the market on DefenCath, and may impede further small and medium-size providers to work with CorMedix. Separately, there is also risk that supply chains become disrupted because of heightened global geopolitical risk, displacing global shipping routes in Europe. Currently, the company only has one outsourced manufacturer based in Europe. Although CorMedix is in the process of onboarding a US-based manufacturer, there is no guarantee they will finalize the contract or done in time before a supply chain disruption. Either case would impair CorMedix ability to supply DefenCath to both inpatient and outpatient settings. Conclusion CorMedix is an old biotech company in an old market setting. The company has a checkered past, and the promise of bringing a novel catheter lock solution to the US market has always seemed so close yet so far. The roller coaster of two CRLs over three years has left existing shareholders mute as they watched the rest of the market roar to new heights. However, there is a new CorMedix being born. Reinvigorated leadership, FDA approval for DefenCath, partnerships, and exciting commercial execution are springing the company to new life. Profitability is in sight by year-end and market demand is intact with and without reimbursement coverage. The successful launch in the US hemodialysis market in 2024 has propelled CorMedix into the investor mainstream with significant analyst upgrades.  Upon looking at CorMedix financial and business outlook in only the hemodialysis market, the current share price is still playing to catch up to the company's commercial prospects. 2025 is lining up to be an exciting year for CorMedix, hemodialysis patients, and shareholders.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"analysis","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2479899456"}