Revenue and Profitability - Revenue for the three months ended March 31, 2025, was $39.1 million, compared to $0 for the same period in 2024, reflecting the launch of DefenCath[125] - Gross profit for the three months ended March 31, 2025, was $37.5 million, compared to a gross loss of $0.8 million for the same period in 2024, representing a 4,680% increase[125] - Income from operations for the three months ended March 31, 2025, was $20.1 million, compared to a loss of $16.7 million for the same period in 2024, reflecting a 220% increase[125] - Net income for the three months ended March 31, 2025, was $20.6 million, compared to a net loss of $14.5 million for the same period in 2024, representing a 243% increase[125] - The company achieved profitability in the fourth quarter of 2024 and the first quarter of 2025, driven by product sales of DefenCath[134] Expenses - Cost of revenue for the three months ended March 31, 2025, was $1.6 million, an increase from $0.8 million for the same period in 2024, due to manufacturing and distribution costs associated with DefenCath[126] - Research and development expense for the three months ended March 31, 2025, was $3.2 million, an increase of 281% from $0.8 million for the same period in 2024, primarily due to increased personnel and clinical trial services[127] - Selling and marketing expense for the three months ended March 31, 2025, was $4.5 million, a decrease of 29% from $6.3 million for the same period in 2024, attributed to the severance of the internal sales force[128] - General and administrative expense for the three months ended March 31, 2025, was $9.7 million, an increase of 11% from $8.7 million for the same period in 2024, driven by non-cash stock-based compensation charges[129] Cash Flow and Investments - Net cash provided by operating activities was $19.7 million for the three months ended March 31, 2025, compared to a net cash used of $17.3 million for the same period in 2024, driven by a net income of $20.6 million[136] - Total cash, cash equivalents, and short-term investments as of March 31, 2025, was $77.5 million, up from $51.7 million as of December 31, 2024[139] - Net cash provided by financing activities was $6.1 million for the three months ended March 31, 2025, primarily from the sale of common stock under the ATM program[138] - Net cash used in investing activities was $0.2 million for the three months ended March 31, 2025, compared to $8.9 million of net cash provided in the same period in 2024[137] - The company expects to fund operations for at least twelve months from the issuance of these financial statements based on current cash resources[142] Product Information - DefenCath is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., shown to reduce the risk of catheter-related bloodstream infections by up to 71% in clinical studies[109] - DefenCath has new chemical entity exclusivity for 5 years expiring on November 15, 2028, with an additional 5-year exclusivity extension under the GAIN Act expiring on November 15, 2033[110] Agreements and Future Plans - The company entered into a three-year agreement with Syneos Health for a dedicated inpatient field sales force to promote DefenCath, with a minimum commitment of $9.1 million[145] - As of March 31, 2025, the company maintained a full valuation allowance against deferred tax assets due to uncertainty regarding future profitability[151] - The company has $23.2 million of common stock available for potential sale under the ATM program as of March 31, 2025[139] Interest Income - Interest income decreased by $0.2 million, or 25%, to $0.6 million for the three months ended March 31, 2025, compared to $0.8 million for the same period last year[130]

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, achieving profitability with a net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [14][15]. - Adjusted EBITDA for the first quarter was $23.6 million, slightly above earlier preannounced results [6]. Business Line Data and Key Metrics Changes - The company experienced steady utilization growth with existing anchor customer U.S. Renal Care and new utilization from smaller outpatient dialysis operators and inpatient hospitals [6]. - Inpatient hospital ordering accounted for more than 6% of shipments in April, more than double from the first quarter [7]. Market Data and Key Metrics Changes - U.S. Renal Care accounted for over 80% of shipments in the first quarter, indicating its significance as the largest customer [30][31]. - The company anticipates utilization growth in the latter half of 2025 as new patients initiate therapy and new customers are added [9]. Company Strategy and Development Direction - CorMedix is focused on expanding its customer base and therapeutic indications for DEFENCATH, with a dedicated inpatient sales team now fully operational [10][13]. - The company has initiated a Phase 3 clinical study targeting central line-associated bloodstream infections, aiming for FDA submission by late 2026 or early 2027 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the implementation timeline with a large dialysis operator customer, expecting to start mid-2025 [9]. - The company is monitoring macroeconomic factors but does not foresee them impacting inventory or earnings significantly [25]. Other Important Information - Operating expenses increased by approximately 9% to $17.4 million, with R&D expenses rising by 281% due to increased personnel and clinical trial services [15][16]. - The company has cash and cash equivalents of $77.5 million as of March 31, 2025 [16]. Q&A Session Summary Question: Updates on LDO partnership and operational expectations - Management noted heightened preparatory activities with the LDO but did not provide specific patient numbers or timelines [20][22]. Question: Inventory control and macroeconomic impacts - Management clarified that current macroeconomic issues are not affecting inventory, which is well-stocked to meet demand [25][26]. Question: Drivers behind Q1 revenue and customer contributions - U.S. Renal Care was the primary driver of revenue, accounting for over 80% of shipments, with growth also seen in smaller customers and hospitals [30][31]. Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with MA plans during TDAPA coverage, with 40% of claims currently from MA plans [46][47]. Question: Inpatient segment growth potential - Management indicated that the inpatient segment has potential for growth but is difficult to quantify at this stage [52][53].

‒ 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]