‒ Q1 2025 Net Revenue of $39.1mm; Adjusted EBITDA of $23.6mm ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time BERKELEY HEIGHTS, NJ., May 06, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life- threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2025 and provided an update on its business. Recent Corporate Highlights: First Quarter 202 ...

Core Insights - CorMedix Inc. will report its financial results for Q1 2025 on May 6, 2025, before market opens [1] - The company will host a corporate update conference call at 8:30 AM ET on the same day [2] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases [2] - The company's lead product, DefenCath® (taurolidine and heparin), received FDA approval on November 15, 2023 [2] - DefenCath was commercially launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] - CorMedix plans to commence clinical studies in Total Parenteral Nutrition and Pediatric patient populations in 2025 [2] - The company also intends to develop DefenCath as a catheter lock solution for other patient populations [2]

Financial Results - CorMedix Inc. announced preliminary financial results for Q1 2025 on April 8, 2025[6] - The company provided a business update alongside the financial results[6] - The press release detailing these results is included as Exhibit 99.1[6]

Core Insights - CorMedix Inc. reported preliminary unaudited net revenue of $39.0 million for Q1 2025 and expects adjusted EBITDA to exceed $22.5 million [1][5] - The company has increased its H1 2025 net sales guidance to a range of $62 million to $70 million due to larger than expected orders and improved visibility into inventory levels [5] - Cash and cash equivalents as of March 31, 2025, amounted to approximately $77.5 million [1][5] Financial Performance - Q1 2025 unaudited net revenue: $39.0 million [1][5] - Expected Q1 2025 adjusted EBITDA: above $22.5 million [1][5] - Cash and cash equivalents: approximately $77.5 million as of March 31, 2025 [1][5] Business Updates - CorMedix is focused on commercializing its lead product DefenCath®, which was FDA approved on November 15, 2023, and launched in inpatient settings in April 2024 and outpatient settings in July 2024 [3] - The company plans to commence clinical studies in Total Parenteral Nutrition and pediatric patient populations in 2025 [3] - Expected peak annual sales for DefenCath in the Total Parenteral Nutrition patient population could reach between $150 million to $200 million, with a total addressable market of $500 million to $750 million [5]

Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions [2] - The company is commercializing its lead product DefenCath® (taurolidine and heparin), which received FDA approval on November 15, 2023 [2] - DefenCath was launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] Upcoming Events - Management will participate in the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025 [1] - A fireside chat is scheduled for April 8, 2025, at 2:15 p.m. EDT [2] Clinical Development - CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 [2] - The company intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas [2]

Group 1 - CorMedix Inc. is a growth company benefiting from the launch of its new drug, DefenCath, which has received FDA approval in 2023 [1] - DefenCath specifically addresses catheter-related bloodstream infections in patients undergoing hemodialysis [1] Group 2 - The company is positioned in a niche market with significant potential for growth due to the specific medical need it addresses [1]

Group 1 - CorMedix Inc. is under investigation by Bragar Eagel & Squire, P.C. for potential violations of federal securities laws and unlawful business practices [1] - On March 25, 2025, CorMedix reported its fourth quarter and full year 2024 financial results, indicating expectations of net price erosion starting in Q2 2025, which led to a decline in the company's stock price [2] - The law firm is reaching out to long-term stockholders of CorMedix who may have suffered losses and is encouraging them to participate in the investigation [3] Group 2 - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents investors in various complex litigations across state and federal courts [4]

Core Insights - CorMedix Inc. is under investigation by Holzer & Holzer, LLC for potential non-compliance with federal securities laws following the announcement of its fourth quarter and full year 2024 financial results [1] - The company anticipates net price erosion starting in the second quarter of 2025, which has negatively impacted its stock price [1] Financial Performance - CorMedix reported its fourth quarter and full year 2024 financial results on March 25, 2025 [1] - The earnings call indicated expectations of net price erosion beginning in Q2 2025 [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation and has a history of representing shareholders in cases of corporate misconduct [3] - The firm has recovered hundreds of millions of dollars for shareholders since its founding in 2000 [3]

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $31.2 million, and for the full year 2024, it was $43.5 million, both exceeding Wall Street consensus [8][22] - The company achieved its first profitable commercial quarter with a net income of $13.5 million, compared to a net loss of $14.8 million in Q4 2023 [22] - Operating expenses in Q4 2024 increased by 9% to $17.1 million compared to $15.7 million in Q4 2023, driven by higher selling and marketing and G&A expenses [23] - Full year 2024 total operating expenses amounted to $62.6 million, an increase of 28% from $49 million in 2023 [26] Business Line Data and Key Metrics Changes - The outpatient segment was the primary driver of revenue growth, with strong uptake from US Renal Care and other customers [9] - Inpatient utilization is expected to increase as the new inpatient sales team becomes active, with a focus on larger hospitals and VA facilities [12][13] Market Data and Key Metrics Changes - The company anticipates net revenue from existing purchasing customers for the first six months of 2025 to be in the range of $50 million to $60 million, with over $33 million expected in Q1 [9] - The company noted that DefenCath's net selling price has remained stable, but some net price erosion is expected starting in Q2 2025 [10] Company Strategy and Development Direction - CorMedix is focused on expanding the use of DefenCath to new therapeutic indications and increasing its existing customer base [32] - The company is reorganizing its inpatient commercialization strategy and partnering with Syneos Health to build a dedicated inpatient field team [12][13] - Clinical developments include a Phase 3 study for reducing CLABSIs in TPN patients, with an expected FDA submission by the end of 2026 [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for new patient growth and the importance of large dialysis organization customer implementation for future volume growth [11] - The company is preparing for increased R&D spending on clinical initiatives in 2025, with cash operating expenses expected to be between $72 million and $78 million [30] Other Important Information - The company has cash and cash equivalents of $51.7 million as of December 31, 2024, and anticipates completing Q1 2025 with at least $75 million [29][30] - The company is fielding a high number of requests for participation in an expanded access program for high-risk populations [20] Q&A Session Summary Question: What are the first steps for the inpatient sales team once they're fully launched? - Management indicated that the team will focus on large academic medical centers and support hospitals that are already in the P&T process [34][38] Question: Can you elaborate on the expected net price erosion starting in Q2? - Management noted that while they cannot provide an exact percentage, they expect some discounts and rebates off government ASP, with a stable outlook for the next quarter [40][42] Question: Can you provide an update on the contracted LDO's process and interactions? - Management confirmed ongoing support and information requests from the contracted LDO, expressing hope for implementation by midyear [49][51] Question: What is the current business mix between various MDOs? - Management stated that US Renal Care remains over 80% of orders, but this percentage is decreasing [80] Question: How does the recent FDA acknowledgment of bloodline shortages impact DefenCath? - Management indicated that there would likely be no impact on DefenCath utilization due to alternative manufacturers available [70][72]

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $31.2 million, and for the full year 2024, it was $43.5 million, both exceeding Wall Street consensus [8][22] - The company achieved its first profitable commercial quarter with a net income of $13.5 million, compared to a net loss of $14.8 million in Q4 2023 [22] - Adjusted EBITDA for Q4 2024 was $15.3 million [8] - Total operating expenses for full year 2024 were $62.6 million, an increase of 28% from $49 million in 2023 [26] Business Line Data and Key Metrics Changes - The outpatient segment was the primary driver of revenue growth, with strong uptake from US Renal Care and other midsized customers [9][12] - Inpatient utilization is expected to increase as the new inpatient sales team is nearly fully staffed and will be active soon [13][14] - The company reported a decrease in R&D expenses by 70% to $3.9 million for the full year 2024, driven by the approval of DefenCath [27] Market Data and Key Metrics Changes - The company anticipates net revenue from existing purchasing customers for the first six months of 2025 to be in the range of $50 million to $60 million, with over $33 million expected in Q1 [9] - The inpatient segment is currently about 3% of unit volume and 4% to 5% of dollars, with a target to increase this to 10% by 2026 [36] Company Strategy and Development Direction - CorMedix is focused on expanding the use of DefenCath to new therapeutic indications and increasing its existing customer base [32] - The company has partnered with Syneos Health to build a dedicated inpatient field team and with WSI for marketing resources targeting Veterans Administration facilities [13][14] - The company is also pursuing clinical studies to support the expanded use of its products, including a Phase 3 study for TPN [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for new patient growth and the importance of large dialysis organization customer implementation for future volume growth [11] - The company expects to see net price erosion beginning in Q2 2025, but the exact percentage is uncertain [10][42] - Management noted that the recent policy changes from CMMI have positively impacted patient uptake, with a 15% to 20% lift in patient numbers observed [88] Other Important Information - The company has cash and cash equivalents of $51.7 million as of December 31, 2024, and anticipates completing Q1 2025 with at least $75 million [29][30] - The company is fielding a high number of requests for participation in its expanded access program for high-risk populations [20] Q&A Session Summary Question: What are the first steps for the inpatient sales team once fully launched? - Management indicated that the team will focus on large academic medical centers and support existing orders while aligning with VA medical centers [38] Question: Can you elaborate on the expected net price erosion starting in Q2? - Management mentioned that while they cannot provide an exact percentage, they expect some discounts and rebates off government ASP, with stability in the second quarter and a potential decrease in the third quarter [40][42] Question: What is the status of the contracted LDO and the potential for new customers? - Management confirmed ongoing communication with the contracted LDO and efforts to engage smaller providers, with hopes for increased ordering size and frequency [54][56] Question: How is the company preparing for the Medicare Advantage market? - Management noted a growing trend towards Medicare Advantage claims, with expectations that this segment will continue to grow, providing opportunities for CorMedix [64] Question: Will the recent bloodline shortages impact DefenCath utilization? - Management indicated that alternative manufacturers are available, so they do not anticipate any impact on DefenCath utilization [72] Question: What is the current status of DefenCath manufacturing capacity? - Management confirmed that they have more than a year's worth of finished dosage on hand and are well situated to meet demand [77]