Financial Results - CorMedix Inc. announced preliminary financial results for Q4 and the year ended December 31, 2024[4]. - The press release detailing these results was issued on January 7, 2025[4]. - The report does not include specific financial metrics or performance indicators[4]. - The report does not provide future guidance or performance outlook[4]. Company Information - The company is listed on the Nasdaq Global Market under the trading symbol CRMD[2]. - The company is not classified as an emerging growth company under the Securities Act[3]. - The report is intended to comply with the requirements of the Securities Exchange Act of 1934[5]. - The financial statements and exhibits related to the report are included as Exhibit 99.1 and Exhibit 104[7]. Management - The company’s CEO, Joseph Todisco, signed the report[11]. Product and Strategy - There is no mention of new product development or market expansion strategies in the provided content[4].

Core Insights - CorMedix Inc. reported a net revenue of $31.2 million for Q4 2024 and $43.5 million for the full year 2024, marking significant growth driven by the launch of its product DefenCath [1][3][4] - The company achieved its first profitable quarter in history with a net income of $13.5 million in Q4 2024, compared to a net loss of $14.8 million in Q4 2023 [3][4][6] - Operating expenses for Q4 2024 were $17.1 million, an increase of approximately 9% from $15.7 million in Q4 2023, primarily due to higher general and administrative expenses [4][5] Financial Performance - For the year ended December 31, 2024, CorMedix recorded a net loss of $17.9 million, a significant improvement from a net loss of $46.3 million in 2023 [6][7] - Operating expenses for the full year 2024 totaled $62.6 million, up from $49.0 million in 2023, reflecting increased marketing and commercial activities [7][8] - The company anticipates preliminary net revenue guidance for the first half of 2025 to be between $50 million and $60 million, with over $33 million expected in Q1 2025 [4][6] Product Development and Market Strategy - CorMedix is focused on expanding the utilization of DefenCath in both outpatient and inpatient settings, with a dedicated sales team expected to begin activities in Q2 2025 [4][10] - The company has initiated a Phase 3 study of DefenCath for patients receiving Total Parenteral Nutrition (TPN) and has applied for Orphan Drug Status with the FDA [4][10] - Partnerships with Syneos Health and WSI have been established to enhance sales and marketing efforts for DefenCath, particularly in VA facilities [4][10] Cash Position - As of December 31, 2024, CorMedix had cash and short-term investments of $51.7 million, with expectations to exceed $75 million by the end of Q1 2025 [4][8]

Financial Performance - CorMedix Inc. is set to release its fourth-quarter financial results on March 25, with analysts expecting earnings of 14 cents per share, a significant improvement from a loss of 26 cents per share in the same period last year [1] - The company projects quarterly revenue of $28.34 million [1] Business Developments - On January 21, CorMedix announced its engagement with WSI PBG to promote DefenCath® to healthcare providers in facilities operated by the Department of Veterans Affairs and other federal facilities [2] - Following this announcement, CorMedix shares increased by 0.5%, closing at $10.91 [2] Analyst Ratings - Needham analyst Serge Belanger maintained a Buy rating and raised the price target from $10 to $18, with an accuracy rate of 69% [4] - Truist Securities analyst Joon Lee also maintained a Buy rating, increasing the price target from $12 to $17, with an accuracy rate of 78% [4]

Core Insights - CorMedix Inc. is set to report its financial results for Q4 and the full year of 2024 on March 25, 2025, before market opening [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 [3] - The company's lead product, DefenCath® (taurolidine and heparin), received FDA approval on November 15, 2023, and was commercially launched in inpatient settings in April 2024 and outpatient settings in July 2024 [3] - CorMedix plans to commence clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patients in 2025, and aims to develop DefenCath as a catheter lock solution for other therapeutic areas [3]

Core Insights - CorMedix Inc. has engaged WSI PBG to promote its product DefenCath to healthcare providers in facilities operated by the Department of Veterans Affairs and other federal facilities, aiming to enhance access for approximately 40,000 veterans with end-stage renal disease [1][2] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, with its lead product DefenCath (taurolidine and heparin) approved by the FDA on November 15, 2023 [3] - The company launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024, and plans to commence clinical studies in adult Total Parenteral Nutrition patients and pediatric hemodialysis patient populations in 2025 [3] Collaboration Details - The collaboration with WSI PBG leverages their expertise in navigating the VA and federal facilities, focusing on access, procurement processes, and regulations to meet the unique needs of federal healthcare systems [2] - Joe Todisco, CEO of CorMedix, expressed excitement about the collaboration, highlighting WSI PBG's understanding of the federal healthcare landscape to improve access to DefenCath for veterans and other beneficiaries [3]

Core Insights - CorMedix's shares increased nearly 30% following the announcement of preliminary sales figures for Q4 and full-year 2024 [1] - Preliminary net revenues for Q4 2024 reached approximately $31 million, surpassing the Zacks Consensus Estimate of $21.5 million, with adjusted EBITDA expected to exceed $12 million [2] - For the full year 2024, preliminary net revenues were about $43 million, exceeding the Zacks Consensus Estimate of $33.8 million, with cash and short-term investments totaling around $52 million at year-end [3] Company Performance - The sales figures are likely attributed to the sales of DefenCath, CorMedix's sole marketed product, which received FDA approval in November 2023 [4] - CorMedix has exceeded its previous guidance of achieving break-even by the end of 2024, although no specific bottom-line numbers were provided [5] - Over the past year, CorMedix's shares have surged 185.3%, contrasting with a 15.7% decline in the industry [5] Business Strategy - CorMedix plans to expand its efforts in the inpatient hospital segment in 2025, collaborating with Syneos Health to create a dedicated field sales team for DefenCath [7] - The company anticipates that the expanded deployment and internal realignment will have a neutral impact on overall sales and marketing expenses, projecting operating expenses between $72 million and $78 million [8] - CorMedix is working with its Large Dialysis Operator customer to implement DefenCath, targeting a patient utilization of 4,000 by the second half of 2025, with existing purchase orders exceeding $25 million for Q1 2025 [9]

Financial Performance - CorMedix Inc. reported preliminary unaudited net revenue of approximately $31 million for Q4 2024 and approximately $43 million for FY 2024 [1][3] - The company expects Q4 2024 adjusted EBITDA to exceed $12 million [1][3] - Preliminary unaudited cash and short-term investments as of December 31, 2024, are approximately $52 million [3] Business Developments - The company is actively shipping DefenCath to all three midsized dialysis operator customers, with continuous ordering of increasing size throughout the quarter [3] - CorMedix has over $25 million of existing open purchase orders scheduled for delivery during Q1 2025 [3] - An expanded deployment effort in the inpatient hospital segment is set to begin in Q1 2025, with Syneos Health engaged to build a dedicated inpatient field sales team [3] Clinical Initiatives - A final clinical study protocol for DefenCath in Total Parenteral Nutrition (TPN) was submitted to the FDA in Q4, with study enrollment expected to begin in H1 2025 [3] - Patient enrollment in the pediatric study for DefenCath in pediatric hemodialysis is expected to begin in H2 2025 [3] Operational Guidance - The company estimates that the expanded inpatient deployment and internal commercial realignment will be cost neutral on overall sales and marketing expenses in 2025 [3] - Preliminary operating expense guidance for FY 2025 is set at $72 million to $78 million, excluding non-cash and one-time items, with the increase primarily driven by R&D spending [3]

Group 1: Company Performance - CorMedix (CRMD) has achieved a year-to-date performance increase of approximately 126.1%, significantly outperforming the average loss of 3.5% in the Medical sector [6] - ResMed (RMD) has also shown strong performance with a year-to-date return of 36% [6] - The Zacks Consensus Estimate for CRMD's full-year earnings has increased by 20.7% over the past three months, indicating a positive trend in analyst sentiment [5] Group 2: Industry Rankings - CorMedix is part of the Medical - Biomedical and Genetics industry, which consists of 501 individual stocks and currently ranks 61 in the Zacks Industry Rank [1] - The Medical - Products industry, which includes ResMed, has 87 stocks and is ranked 127 [1] - The Medical sector overall includes 1020 individual stocks and holds a Zacks Sector Rank of 2 [4]

BERKELEY HEIGHTS, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced it will be added to the Nasdaq Biotechnology Index (NASDAQ:NBI) (the "NBI"). CorMedix's addition to the NBI will become effective prior to the market open on Monday, December 23, 2024. The NBI is designed to track the performance of a set of securities listed on The NASDA ...

BERKELEY HEIGHTS, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) released important policy updates that will broaden the access of Medicare patients m ...