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]

CorMedix Inc. (NASDAQ:CRMD) Q4 2024 Earnings Conference Call March 25, 2025 8:30 AM ET Company Participants Dan Ferry - Managing Director, LifeSci Advisors Joe Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Erin Mistry - Executive Vice President and Chief Commercial Officer Liz Hurlburt - Executive Vice President, Chief Clinical Strategy and Operations Officer Conference Call Participants Roanna Ruiz - Leerink Partners Jason Butler - Citizens JMP Anish Ni ...

Core Insights - CorMedix (CRMD) reported quarterly earnings of $0.22 per share, exceeding the Zacks Consensus Estimate of $0.17 per share, and a significant improvement from a loss of $0.26 per share a year ago, representing an earnings surprise of 29.41% [1] - The company achieved revenues of $31.21 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 1.39%, compared to zero revenues a year ago [2] - CorMedix shares have increased approximately 33% since the beginning of the year, contrasting with a decline of -1.9% in the S&P 500 [3] Earnings Outlook - The future performance of CorMedix's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - The current consensus EPS estimate for the upcoming quarter is $0.15 on revenues of $31.02 million, and for the current fiscal year, it is $0.94 on revenues of $174.12 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which CorMedix belongs, is currently ranked in the top 30% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact CorMedix's stock performance [5]

Revenue and Profit - Revenue for the year ended December 31, 2024 was $43.5 million, compared to $0 for the same period in 2023, reflecting the launch of DefenCath[210]. - Gross profit for the year ended December 31, 2024 was $40.3 million, with a cost of revenue of $3.2 million[209][211]. - For the year ended December 31, 2024, the company achieved revenue of $31.2 million in the fourth quarter, a significant increase compared to $11.5 million in the third quarter and $0.8 million in the second quarter[219]. - The company reported a net income of $12.9 million in the fourth quarter, contrasting with a net loss of $3.3 million in the third quarter and a loss of $15.3 million in the second quarter[219]. Expenses - Research and development expenses decreased by 70% to $3.9 million for the year ended December 31, 2024, down from $13.2 million in 2023[212]. - Selling and marketing expenses increased by 59% to $28.7 million for the year ended December 31, 2024, compared to $18.1 million in 2023[213]. - General and administrative expenses rose by 69% to $30.0 million for the year ended December 31, 2024, up from $17.7 million in 2023[214]. Losses - The loss from operations for the year ended December 31, 2024 was $22.4 million, a 54% decrease from the loss of $49.0 million in 2023[209]. - The net loss for the year ended December 31, 2024 was $17.9 million, a 61% decrease from the net loss of $46.3 million in 2023[209]. Product Information - DefenCath is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., shown to reduce the risk of CRBSI by up to 71% in clinical studies[194]. - DefenCath received NTAP reimbursement of 75% of the wholesaler acquisition cost per hospital stay, with a potential maximum NTAP of $3,656.10[193]. - The company estimates that up to 100,000 HD-CVC placements occur each year, with pass-through status providing separate reimbursement under Medicare for DefenCath[197]. Cash Flow and Investments - The company generated net cash used in operating activities of $50.6 million for the year ended December 31, 2024, an increase of $12.2 million from $38.4 million in 2023[222]. - Net cash provided by investing activities was $21.2 million for the year ended December 31, 2024, compared to a net cash used of $17.1 million in 2023[223]. - The company had total cash, cash equivalents, and short-term investments of $51.7 million as of December 31, 2024, down from $76.0 million in 2023[225]. Future Expectations and Agreements - The company expects to continue funding operations through cash collections and capital raising sources, which may be dilutive to existing stockholders[226]. - A three-year agreement with Syneos Health Commercial Services was entered into in December 2024, committing the company to a minimum of $9.6 million for promoting DefenCath[230]. - The company anticipates payment of $2 million in net sales milestones in 2025 under the ND License Agreement with ND Partners, LLP[231]. - The company received $1.4 million from the sale of unused New Jersey net operating losses in March 2024, contributing to its tax benefit[221]. - The company has $30.2 million of common stock available for potential sale under the ATM program as of December 31, 2024[225].