CorMedix Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
CorMedix (NASDAQ: CRMD) reported strong financial results for Q4 and full year 2024, marking its first profitable commercial quarter. The company achieved Q4 net revenue of $31.2 million and full-year revenue of $43.5 million, primarily driven by DefenCath sales since its outpatient launch in July 2024.
Q4 highlights include net income of $13.5 million and adjusted EBITDA of $15.3 million. The company ended 2024 with $51.7 million in cash and short-term investments. CorMedix provided preliminary guidance for H1 2025 with expected net revenue of $50-60 million, including over $33 million in Q1.
Key developments include partnering with Syneos Health for inpatient sales team building and WSI for VA facilities marketing. The company is preparing to commence a Phase 3 study of DefenCath in Total Parenteral Nutrition patients in Q2 2025, with a pending FDA Orphan Drug Status application.
CorMedix (NASDAQ: CRMD) ha riportato risultati finanziari solidi per il Q4 e l'intero anno 2024, segnando il suo primo trimestre commerciale profittevole. L'azienda ha raggiunto un fatturato netto di $31,2 milioni nel Q4 e un fatturato annuale di $43,5 milioni, principalmente grazie alle vendite di DefenCath dalla sua lancio ambulatoriale nel luglio 2024.
I punti salienti del Q4 includono un reddito netto di $13,5 milioni e un EBITDA rettificato di $15,3 milioni. L'azienda ha chiuso il 2024 con $51,7 milioni in contante e investimenti a breve termine. CorMedix ha fornito indicazioni preliminari per il primo semestre del 2025, con un fatturato netto previsto di $50-60 milioni, inclusi oltre $33 milioni nel Q1.
Sviluppi chiave includono la partnership con Syneos Health per la creazione di un team di vendita per pazienti ricoverati e con WSI per il marketing nelle strutture VA. L'azienda si sta preparando a iniziare uno studio di Fase 3 di DefenCath in pazienti in nutrizione parenterale totale nel Q2 2025, con una domanda in sospeso per lo stato di farmaco orfano FDA.
CorMedix (NASDAQ: CRMD) reportó resultados financieros sólidos para el Q4 y el año completo 2024, marcando su primer trimestre comercial rentable. La empresa logró ingresos netos de $31.2 millones en el Q4 y ingresos anuales de $43.5 millones, impulsados principalmente por las ventas de DefenCath desde su lanzamiento ambulatorio en julio de 2024.
Los aspectos destacados del Q4 incluyen un ingreso neto de $13.5 millones y un EBITDA ajustado de $15.3 millones. La empresa terminó 2024 con $51.7 millones en efectivo e inversiones a corto plazo. CorMedix proporcionó una guía preliminar para el primer semestre de 2025 con ingresos netos esperados de $50-60 millones, incluyendo más de $33 millones en el Q1.
Los desarrollos clave incluyen una asociación con Syneos Health para la construcción del equipo de ventas para pacientes hospitalizados y con WSI para el marketing en instalaciones de VA. La empresa se está preparando para comenzar un estudio de Fase 3 de DefenCath en pacientes de nutrición parenteral total en el Q2 de 2025, con una solicitud pendiente para el estado de medicamento huérfano de la FDA.
CorMedix (NASDAQ: CRMD)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고하며, 첫 번째 상업적 수익성 분기를 기록했습니다. 이 회사는 4분기 순수익 3,120만 달러와 연간 수익 4,350만 달러를 달성했으며, 이는 주로 2024년 7월에 시작된 DefenCath의 외래 판매에 의해 주도되었습니다.
4분기 하이라이트에는 순이익 1,350만 달러와 조정 EBITDA 1,530만 달러가 포함됩니다. 이 회사는 2024년을 5,170만 달러의 현금 및 단기 투자로 마감했습니다. CorMedix는 2025년 상반기에 예상 순수익 5천만~6천만 달러, 1분기에 3천3백만 달러 이상의 수익을 포함한 초기 가이드를 제공했습니다.
주요 개발 사항에는 입원 환자 판매 팀 구축을 위한 Syneos Health와의 파트너십 및 VA 시설 마케팅을 위한 WSI와의 협력이 포함됩니다. 이 회사는 2025년 2분기에 Total Parenteral Nutrition 환자를 대상으로 DefenCath의 3상 연구를 시작할 준비를 하고 있으며, FDA의 오르판 약물 상태 신청이 보류 중입니다.
CorMedix (NASDAQ: CRMD) a annoncé de solides résultats financiers pour le 4ème trimestre et l'année complète 2024, marquant son premier trimestre commercial rentable. L'entreprise a réalisé un chiffre d'affaires net de 31,2 millions de dollars au 4ème trimestre et un chiffre d'affaires annuel de 43,5 millions de dollars, principalement tiré par les ventes de DefenCath depuis son lancement en ambulatoire en juillet 2024.
Les points forts du 4ème trimestre comprennent un revenu net de 13,5 millions de dollars et un EBITDA ajusté de 15,3 millions de dollars. L'entreprise a terminé 2024 avec 51,7 millions de dollars en liquidités et investissements à court terme. CorMedix a fourni des orientations préliminaires pour le premier semestre 2025, avec un chiffre d'affaires net attendu de 50 à 60 millions de dollars, dont plus de 33 millions de dollars au 1er trimestre.
Les développements clés incluent un partenariat avec Syneos Health pour la constitution d'une équipe de vente pour les patients hospitalisés et avec WSI pour le marketing dans les établissements de VA. L'entreprise se prépare à commencer une étude de phase 3 de DefenCath chez des patients en nutrition parentérale totale au 2ème trimestre 2025, avec une demande en attente pour le statut de médicament orphelin auprès de la FDA.
CorMedix (NASDAQ: CRMD) hat starke Finanzergebnisse für das 4. Quartal und das gesamte Jahr 2024 gemeldet und damit sein erstes profitables Handelsquartal markiert. Das Unternehmen erzielte im 4. Quartal einen Nettoumsatz von 31,2 Millionen USD und einen Jahresumsatz von 43,5 Millionen USD, hauptsächlich getrieben durch die Verkäufe von DefenCath seit dessen ambulanter Einführung im Juli 2024.
Die Highlights des 4. Quartals umfassen einen Nettogewinn von 13,5 Millionen USD und ein bereinigtes EBITDA von 15,3 Millionen USD. Das Unternehmen schloss das Jahr 2024 mit 51,7 Millionen USD an Bargeld und kurzfristigen Investitionen ab. CorMedix gab eine vorläufige Prognose für das erste Halbjahr 2025 ab, mit einem erwarteten Nettoumsatz von 50-60 Millionen USD, einschließlich über 33 Millionen USD im 1. Quartal.
Wichtige Entwicklungen umfassen die Partnerschaft mit Syneos Health zum Aufbau eines Verkaufsteams für stationäre Patienten und mit WSI für das Marketing in VA-Einrichtungen. Das Unternehmen bereitet sich darauf vor, im 2. Quartal 2025 eine Phase-3-Studie zu DefenCath bei Patienten mit totaler parenteraler Ernährung zu beginnen, mit einem ausstehenden Antrag auf den Status eines Waisenkindes von der FDA.
- First profitable quarter with Q4 net income of $13.5M
- Strong Q4 revenue of $31.2M and full-year revenue of $43.5M
- Projected H1 2025 revenue of $50-60M shows significant growth
- Healthy cash position of $51.7M at year-end
- Successful DefenCath commercialization in outpatient setting
- Operating expenses increased 28% YoY to $62.6M in 2024
- Full-year 2024 net loss of $17.9M despite Q4 profitability
- Projected cash operating expenses of $72-78M for 2025
Insights
CorMedix's Q4 results showcase a transformational financial inflection point with their first-ever profitable quarter following the DefenCath launch. Q4 net revenue of $31.2 million and full-year revenue of $43.5 million demonstrate exceptional commercial traction for a newly launched product. Their $13.5 million Q4 net income and $15.3 million adjusted EBITDA mark a decisive shift from cash-burning biotech to cash-generating commercial enterprise.
The preliminary H1 2025 revenue guidance of
Cash position improvements are equally impressive, with
DefenCath's commercial performance significantly exceeds typical expectations for specialty pharmaceutical launches in the dialysis space. The outpatient dialysis market uptake has clearly been the primary revenue driver, while hospital adoption typically follows a more gradual implementation curve due to formulary review processes and purchasing cycles.
The strategic expansion with dedicated inpatient sales and VA facility teams addresses the two highest-value remaining market segments. Hospital adoption represents substantial growth potential as healthcare systems increasingly prioritize catheter-related bloodstream infection prevention to improve outcomes and reduce costs. The Veterans Affairs channel provides access to a concentrated patient population with higher-than-average hemodialysis utilization rates.
CorMedix's clinical development for Total Parenteral Nutrition (TPN) patients represents a logical pipeline expansion. If the Phase 3 study yields positive outcomes and secures the orphan designation they're pursuing, it would open an additional high-margin market segment where infection prevention carries significant clinical and economic benefits. The TPN market, while smaller than dialysis, typically supports premium pricing for effective infection prevention solutions given the immunocompromised nature of these patients and high infection-related costs.
‒ Q4 2024 Net Revenue of
‒ Q4 Net Income of
‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒
BERKELEY HEIGHTS, N.J., March 25, 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 fourth quarter and full year ended December 31, 2024 and provided an update on its business.
Recent Corporate Highlights:
- CorMedix today reports its second full quarter of DefenCath sales since commencing outpatient launch in July 2024 and first partial year of DefenCath sales. The Company reported net sales of
$31.2 million for the fourth quarter and$43.5 million for full year 2024, largely driven by successful implementation by its outpatient dialysis customers. - The Company’s fourth quarter of 2024 was the first profitable commercial quarter in CorMedix history, with net income of
$13.5 million and adjusted EBITDA of$15.3 million . - The Company previously announced a partnership with Syneos Health to build a dedicated inpatient sales team. The staffing of this team is nearly complete and the Company expects the team to initiate activity in the early part of the second quarter. CorMedix has started to see increased DefenCath utilization at a number of larger hospitals and anticipates further inpatient growth throughout 2025 as the new field team commences activity.
- CorMedix previously announced a partnership with WSI to provide marketing and promotional support for DefenCath to VA facilities and this team has commenced activities in the first quarter.
- CorMedix began identifying investigator sites for its Phase 3 study of DefenCath in patients receiving Total Parenteral Nutrition, or TPN, and expects patient enrollment to commence in the second quarter of 2025. In addition, the Company recently submitted an application for Orphan Drug Status for this indication to the FDA.
- CorMedix is announcing preliminary net revenue guidance for first half of 2025 of
$50 –$60 million , based on the run rate of current purchasing customers, with more than$33 million expected in first quarter. In addition, the Company reiterates its previously announced cash operating expense guidance for 2025 of$72 –$78 million . - Cash and short-term investments, excluding restricted cash, at December 31, 2024 amounted to
$51.7 million . The Company currently anticipates ending first quarter of 2025 with more than$75 million in cash and short-term investments.
Joe Todisco, CorMedix CEO, commented, “I am proud of the Company’s recent progress as we execute on our launch objectives and increase patient access to DefenCath across settings of care. We have seen continued growth from existing customers throughout the first quarter and we are focused on growing our patient base in 2025 with both existing and new accounts.”
4th Quarter and Full Year 2024 Financial Highlights
For the fourth quarter of 2024, CorMedix recorded
Operating expenses in the fourth quarter 2024 were
For the year ended December 31, 2024, CorMedix recorded
Operating expenses during the year ended December 31, 2024 amounted to
Total cash on hand, cash equivalents and short-term investments as of December 31, 2024 amounted to
Conference Call Information
The management team of CorMedix will host a conference call and webcast today, March 25, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:
| Tuesday, March 25th @ 8:30am EDT | |
| Domestic: | 1-844-481-2557 |
| International: | 1-412-317-0561 |
| Conference ID: | 10197392 |
| Webcast: | Webcast Link |
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance.
The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results and facilitate an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.
These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
| CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) | ||||||||||||
| For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue | ||||||||||||
| Revenue, net | $ | 31,209,936 | $ | - | $ | 43,472,170 | $ | - | ||||
| Cost of revenues | (1,175,559 | ) | - | (3,190,534 | ) | - | ||||||
| Gross profit | 30,034,377 | - | 40,281,636 | - | ||||||||
| Operating Expenses | ||||||||||||
| Research and development | (1,726,719 | ) | (2,288,889 | ) | (3,942,270 | ) | (13,155,125 | ) | ||||
| Selling and marketing | (8,263,644 | ) | (8,159,662 | ) | (28,736,605 | ) | (18,115,313 | ) | ||||
| General and administrative | (7,108,006 | ) | (5,220,192 | ) | (29,959,150 | ) | (17,687,350 | ) | ||||
| Total operating expenses | (17,098,369 | ) | (15,668,743 | ) | (62,638,025 | ) | (48,957,788 | ) | ||||
| Income (Loss) from Operations | 12,936,008 | (15,668,743 | ) | (22,356,389 | ) | (48,957,788 | ) | |||||
| Other Income (Expense) | ||||||||||||
| Total other income | 528,396 | 914,713 | 3,031,599 | 2,618,561 | ||||||||
| Net Income (Loss) Before Income Taxes | 13,464,404 | (14,754,030 | ) | (19,324,790 | ) | (46,339,227 | ) | |||||
| Tax benefit | - | - | 1,394,770 | - | ||||||||
| Net Income (Loss) | 13,464,404 | (14,754,030 | ) | (17,930,020 | ) | (46,339,227 | ) | |||||
| Other Comprehensive Income (Loss) | ||||||||||||
| Total other comprehensive income (loss) | 1,526 | 9,710 | (3,462 | ) | 11,365 | |||||||
| Other Comprehensive Income (Loss) | $ | 13,465,930 | $ | (14,744,320 | ) | $ | (17,933,482 | ) | $ | (46,327,862 | ) | |
| Net Income (Loss) Per Common Share – Basic | $ | 0.22 | $ | (0.26 | ) | $ | (0.30 | ) | $ | (0.91 | ) | |
| Weighted Average Common Shares Outstanding – Basic | 61,508,510 | 57,393,542 | 58,871,582 | 50,902,931 | ||||||||
| CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEET DATA (Audited) | ||||||
| For the Years Ended December 31, | ||||||
| 2024 | 2023 | |||||
| ASSETS | ||||||
| Cash, cash equivalents and restricted cash | $ | 40,756,138 | $ | 43,823,192 | ||
| Short-term investments | $ | 11,036,857 | $ | 32,388,130 | ||
| Total Assets | $ | 118,845,673 | $ | 82,059,957 | ||
| Total Liabilities | $ | 34,188,723 | $ | 11,917,528 | ||
| Accumulated deficit | $ | (339,630,033 | ) | $ | (321,700,013 | ) |
| Total Stockholders’ Equity | $ | 84,656,950 | $ | 70,142,429 | ||
| CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (Audited) | |||||||
| For the Years Ended December 31, | |||||||
| 2024 | 2023 | ||||||
| Cash Flows from Operating Activities: | |||||||
| Net loss | $ | (17,930,020 | ) | $ | (46,339,227 | ) | |
| Net cash used in operating activities | (50,614,653 | ) | (38,409,480 | ) | |||
| Cash Flows Used in Investing Activities: | |||||||
| Net cash provided by (used in) investing activities | 21,230,713 | (17,061,685 | ) | ||||
| Cash Flows from Financing Activities: | |||||||
| Net cash provided by financing activities | 26,318,595 | 55,916,804 | |||||
| Net (Decrease) Increase in Cash and Cash Equivalents | (3,067,054 | ) | 448,447 | ||||
| Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 43,823,192 | 43,374,745 | |||||
| Cash and Cash Equivalents and Restricted Cash - End of Period | $ | 40,756,138 | $ | 43,823,192 | |||
| CORMEDIX INC. AND SUBSIDIARIES Non-GAAP Reconciliations (Unaudited) | |||||||||
| Three Months Ended December 31, 2024 | Year Ended December 31, 2024 | ||||||||
| Net income (loss) | $ | 13,464,404 | $ | (17,930,020 | ) | ||||
| Adjusted to add (deduct): | |||||||||
| Interest expense (income), net | (500,377 | ) | (2,542,387 | ) | |||||
| Provision for (benefit from) income taxes | - | (1,394,770 | ) | ||||||
| Depreciation and amortization | 133,675 | 309,781 | |||||||
| EBITDA (Non-GAAP) | $ | 13,097,702 | $ | (21,557,396 | ) | ||||
| Adjusted to add (deduct): | |||||||||
| Stock-based compensation expense | 1,193,908 | 6,129,408 | |||||||
| Sales force reorganization expense | 1,055,300 | 1,055,300 | |||||||
| Other Income | (20,000 | ) | (520,000 | ) | |||||
| Adjusted EBITDA (Non-GAAP) | $ | 15,326,910 | $ | (14,892,688 | ) | ||||
FAQ
What were CorMedix (CRMD) Q4 2024 financial results?
How much revenue did DefenCath generate for CRMD in 2024?
What is CorMedix's revenue guidance for H1 2025?
What are CRMD's expansion plans for DefenCath in 2025?
What was CorMedix's cash position at the end of 2024?
