Cormedix Inc. Announces Preliminary First Quarter 2025 Results and Raises H1 2025 Net Sales Guidance
CorMedix (NASDAQ: CRMD) reports strong preliminary Q1 2025 results with unaudited net revenue of $39.0 million and expected adjusted EBITDA exceeding $22.5 million. The company's cash position stands at $77.5 million as of March 31, 2025.
Due to larger than anticipated orders in late March and improved visibility into customer inventory levels, CorMedix has raised its H1 2025 net sales guidance to $62-70 million. While Q2 2025 sales are expected to be lower than Q1 due to shipment timing, patient utilization is forecast to grow throughout 2025, with H2 shipments projected to exceed H1.
The company plans to begin patient enrollment for DefenCath's Phase 3 study in Total Parenteral Nutrition (TPN) patients in late April. If approved, DefenCath's peak annual sales potential in this indication is estimated at $150-200 million, with a total addressable market of $500-750 million.
CorMedix (NASDAQ: CRMD) riporta risultati preliminari forti per il primo trimestre del 2025 con entrate nette non verificate di 39,0 milioni di dollari e un EBITDA rettificato previsto superiore a 22,5 milioni di dollari. La posizione di liquidità dell'azienda è di 77,5 milioni di dollari al 31 marzo 2025.
A causa di ordini maggiori del previsto a fine marzo e di una migliore visibilità sui livelli di inventario dei clienti, CorMedix ha innalzato la sua previsione di vendite nette per il primo semestre del 2025 a 62-70 milioni di dollari. Anche se le vendite del secondo trimestre 2025 sono attese inferiori rispetto al primo trimestre a causa dei tempi di spedizione, si prevede che l'utilizzo da parte dei pazienti cresca durante tutto il 2025, con le spedizioni del secondo semestre che dovrebbero superare quelle del primo semestre.
L'azienda prevede di iniziare l'arruolamento dei pazienti per lo studio di Fase 3 di DefenCath nei pazienti in Nutrizione Parenterale Totale (TPN) a fine aprile. Se approvato, il potenziale di vendite annuali massime di DefenCath in questa indicazione è stimato tra 150-200 milioni di dollari, con un mercato totale indirizzabile di 500-750 milioni di dollari.
CorMedix (NASDAQ: CRMD) informa sobre resultados preliminares sólidos para el primer trimestre de 2025 con ingresos netos no auditados de 39,0 millones de dólares y un EBITDA ajustado esperado que supera los 22,5 millones de dólares. La posición de efectivo de la empresa se sitúa en 77,5 millones de dólares al 31 de marzo de 2025.
Debido a pedidos más grandes de lo anticipado a finales de marzo y una mejor visibilidad en los niveles de inventario de los clientes, CorMedix ha aumentado su guía de ventas netas para el primer semestre de 2025 a 62-70 millones de dólares. Si bien se espera que las ventas del segundo trimestre de 2025 sean inferiores a las del primer trimestre debido a los tiempos de envío, se pronostica que la utilización de pacientes crecerá a lo largo de 2025, con envíos del segundo semestre que se espera superen los del primer semestre.
La empresa planea comenzar el reclutamiento de pacientes para el estudio de Fase 3 de DefenCath en pacientes de Nutrición Parenteral Total (TPN) a finales de abril. Si se aprueba, el potencial de ventas anuales máximas de DefenCath en esta indicación se estima entre 150-200 millones de dólares, con un mercado total direccionable de 500-750 millones de dólares.
CorMedix (NASDAQ: CRMD)는 2025년 1분기 강력한 예비 실적을 보고하며 감사되지 않은 순수익 3,900만 달러와 예상 조정 EBITDA가 2,250만 달러를 초과할 것으로 예상하고 있습니다. 회사의 현금 보유액은 2025년 3월 31일 기준 7,750만 달러입니다.
3월 말에 예상보다 큰 주문과 고객 재고 수준에 대한 개선된 가시성 덕분에 CorMedix는 2025년 상반기 순매출 가이던스를 6,200만~7,000만 달러로 상향 조정했습니다. 2025년 2분기 판매는 배송 시기 때문에 1분기보다 낮을 것으로 예상되지만, 환자 활용도는 2025년 내내 성장할 것으로 예상되며, 하반기 배송량은 상반기를 초과할 것으로 예상됩니다.
회사는 4월 말에 TPN(총 비경구 영양) 환자를 위한 DefenCath의 3상 연구에 대한 환자 등록을 시작할 계획입니다. 승인될 경우, 이 적응증에서 DefenCath의 연간 최대 판매 잠재력은 1억 5천만~2억 달러로 추정되며, 총 주소able 시장은 5억~7억 5천만 달러로 추정됩니다.
CorMedix (NASDAQ: CRMD) annonce de solides résultats préliminaires pour le premier trimestre 2025 avec des revenus nets non audités de 39,0 millions de dollars et un EBITDA ajusté prévu dépassant 22,5 millions de dollars. La position de trésorerie de l'entreprise s'élève à 77,5 millions de dollars au 31 mars 2025.
En raison de commandes plus importantes que prévu fin mars et d'une meilleure visibilité sur les niveaux de stock des clients, CorMedix a rehaussé ses prévisions de ventes nettes pour le premier semestre 2025 à 62-70 millions de dollars. Alors que les ventes du deuxième trimestre 2025 devraient être inférieures à celles du premier trimestre en raison des délais d'expédition, l'utilisation des patients devrait croître tout au long de 2025, avec des expéditions du deuxième semestre qui devraient dépasser celles du premier semestre.
L'entreprise prévoit de commencer le recrutement de patients pour l'étude de Phase 3 de DefenCath chez les patients en Nutrition Parentérale Totale (TPN) fin avril. Si approuvé, le potentiel de ventes annuelles maximales de DefenCath dans cette indication est estimé entre 150-200 millions de dollars, avec un marché total adressable de 500-750 millions de dollars.
CorMedix (NASDAQ: CRMD) berichtet über starke vorläufige Ergebnisse für das erste Quartal 2025 mit unauditierten Nettoumsätzen von 39,0 Millionen Dollar und einem erwarteten bereinigten EBITDA von über 22,5 Millionen Dollar. Die Liquiditätsposition des Unternehmens beträgt zum 31. März 2025 77,5 Millionen Dollar.
Aufgrund größerer als erwarteter Bestellungen Ende März und einer verbesserten Sicht auf die Lagerbestände der Kunden hat CorMedix seine Prognose für den Nettoumsatz im ersten Halbjahr 2025 auf 62-70 Millionen Dollar angehoben. Während die Umsätze im zweiten Quartal 2025 voraussichtlich niedriger sein werden als im ersten Quartal aufgrund von Versandzeitpunkten, wird ein Anstieg der Patientenverwendung im gesamten Jahr 2025 prognostiziert, wobei die Lieferungen im zweiten Halbjahr voraussichtlich die im ersten Halbjahr übertreffen werden.
Das Unternehmen plant, Ende April mit der Patientenrekrutierung für die Phase-3-Studie von DefenCath bei Patienten mit Totaler Parenteraler Ernährung (TPN) zu beginnen. Wenn genehmigt, wird das jährliche Umsatzpotenzial von DefenCath in dieser Indikation auf 150-200 Millionen Dollar geschätzt, mit einem insgesamt adressierbaren Markt von 500-750 Millionen Dollar.
- Strong Q1 2025 revenue of $39.0 million
- Robust adjusted EBITDA exceeding $22.5 million in Q1
- Increased H1 2025 sales guidance to $62-70 million
- Healthy cash position of $77.5 million
- Expected growth in patient utilization throughout 2025
- H2 2025 unit shipments projected to exceed H1
- Q2 2025 net sales expected to be lower than Q1 2025
Insights
CorMedix's preliminary Q1 2025 results reveal exceptional financial performance with
The company's decision to raise H1 2025 revenue guidance to
CorMedix maintains a robust liquidity position with approximately
The forecasted H2 2025 shipments exceeding H1 volumes indicates an accelerating growth trajectory rather than a one-time revenue bump. This pattern of increasing patient utilization throughout 2025 suggests DefenCath is gaining substantial clinical adoption, validating both the product's value proposition and CorMedix's commercial strategy in addressing critical unmet needs in preventing catheter-related bloodstream infections.
CorMedix's commercial momentum for DefenCath is translating into substantial financial results, but the upcoming expansion into the Total Parenteral Nutrition (TPN) market represents a significant growth catalyst. With patient enrollment for the Phase 3 TPN study beginning in late April, the company is strategically expanding beyond its current indications.
The projected peak annual sales of
The current commercial performance indicates strong product-market fit, with the unexpected larger orders suggesting healthcare systems may be accelerating adoption. The company's commentary about continuous growth in patient utilization throughout 2025 signals that DefenCath is becoming a standard of care rather than facing the typical adoption challenges of new antimicrobial products.
CorMedix appears positioned at an inflection point where initial commercial success is funding pipeline expansion, creating a potential virtuous cycle of revenue growth funding additional clinical development, which in turn could drive further revenue expansion in new indications.
‒ Q1 2025 Unaudited Net Revenue of
‒ Expected Q1 Adjusted EBITDA above
‒ Q1 2025 Cash and Cash Equivalents of Approximately
BERKELEY HEIGHTS, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited first quarter results and provides an update on its business. These include the following key updates:
- CorMedix announces preliminary, unaudited net revenue of
$39.0 million for 1Q 2025, and expects 1Q 2025 adjusted EBITDA(1) to exceed$22.5 million once final numbers are reported. - Since providing initial guidance, the Company received larger than expected orders during the final week of March, and has also obtained additional visibility into inventory levels on hand at some of our current purchasing customers. Based on this new information, CorMedix is increasing its H1 2025 guidance for Net Sales to existing purchasing customers to a revised range of
$62 million to$70 million . - While the Company is currently forecasting net sales from existing purchasing customers in 2Q 2025 to be lower than 1Q 2025, this is due to the timing of shipments to those customers between quarters, and does not suggest an anticipated decrease in patient utilization in the second quarter or the second half of 2025. CorMedix currently forecasts patient utilization with existing purchasing customers to continue to grow throughout 2025 as implementation expands to new patients, and currently anticipates unit shipments in H2 2025 to exceed shipments in H1 2025.
- CorMedix expects patient enrollment for our Phase 3 study of DefenCath in patients receiving Total Parenteral Nutrition, or TPN, to begin in late April. The Company believes DefenCath, if approved for this indication, can achieve peak annual sales in this patient population of
$150 million to$200 million , with a total addressable market opportunity of$500 million to$750 million . - Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to approximately
$77.5 million .
The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of the quarterly review procedures of CorMedix’s first quarter 2025 financial statements.
| (1 | ) | Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock based compensation and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the first quarter 2025 financial results. Such reconciliation is not included in this release because the Company is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. | ||
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 Total Parenteral Nutrition and Pediatric patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. 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, including expectations regarding CorMedix’s first quarter 2025 unaudited net revenue, adjusted EBITDA, cash and short-term investments as of March 31, 2025 and increased net sales guidance for the first half of fiscal year 2025, and expectations regarding patient utilization and enrollment. 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.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
FAQ
What is CorMedix's (CRMD) Q1 2025 revenue and EBITDA performance?
What is the new H1 2025 sales guidance for CRMD?
What is the market potential for DefenCath in TPN patients according to CRMD?
How much cash does CRMD have as of Q1 2025?
When will CRMD begin the Phase 3 study for DefenCath in TPN patients?
