CorMedix, Inc. 2026年季度报告

CORMEDIX INC. AND SUBSIDIARIESINDEXPagePART I FINANCIAL INFORMATION1Item 1.Unaudited Condensed Consolidated Financial Statements1Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 20252Condensed Consolidated Statements of Operations and Comprehensive Income for the Three Months EndedMarch 31, 2026 and 20253Condensed ConsolidatedStatements of Changes in Stockholders’ Equity for the Three Months Ended March 31,2026 and 20254Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2026 and 20255Notes to Unaudited Condensed Consolidated Financial Statements6Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations23Item 3.Quantitative and Qualitative Disclosure About Market Risk29Item 4.Controls and Procedures29PART II OTHER INFORMATION31Item 1.Legal Proceedings31Item 1A.Risk Factors31Item 2.Unregistered Sales of Equity Securities and Use of Proceeds31Item 3.Defaults Upon Senior Securities31Item 4.Mine Safety Disclosure32Item 5.Other Information32Item 6.Exhibits33SIGNATURES34 PART IFINANCIAL INFORMATION CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSAND COMPREHENSIVE INCOME(In Thousands, Except Per Share Data)(Unaudited) CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS CORMEDIX INC. AND SUBSIDIARIESNOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Note 1 - Organization, Business and Basis of Presentation Organization and Business CorMedix Inc. ( “CorMedix” or the “Company”) was incorporated in the State of Delaware on July28, 2006. The Companyis a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases andconditions. Prior to the acquisition of Melinta Therapeutics, LLC ("Melinta") in August 2025 (the "merger"), the Company hadfocused on commercialization of its product, DefenCath® (taurolidine and heparin) in the United States. CorMedix launched the The merger with Melinta expanded the Company’s team and commercial platform and increased the commercial portfoliowith six marketed, hospital- and clinic-focused infectious disease products, comprised of REZZAYO® (rezafungin for injection),MINOCIN® (minocycline) for Injection, VABOMERE® (meropenem and vaborbactam), KIMYRSA® (oritavancin), ORBACTIV®(oritavancin), BAXDELA® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL® (metoprololsuccinate) (together, the “Melinta Portfolio”, and, together with DefenCath, “our Products”). REZZAYO is currently approved for thetreatment of candidemia and invasive candidiasis in adults. On April 27, 2026, CorMedix announced positive Phase III topline resultsfrom the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in Given the closing of the merger during the third quarter of 2025, the financial results of Melinta are included in theCompany’s unaudited condensed consolidated financial statements for the quarter ended March31, 2026, but not for the quarter ended Basis of Presentation The preparation of these unaudited condensed consolidated financial statements and accompanying notes are in conformitywith U.S. generally accepted accounting principles (“GAAP”) which requires the use of management estimates. In the opinion ofmanagement, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normalrecurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative ofresults that may be expected for the full year ending December 31, 2026, or for any subsequent period. These unaudited condensed Reclassifications Certain reclassifications were made to the prior year’s amounts to conform to the 2026 presentation. Table of Contents Note 2 - Revenue and Accounts Receivable Concentrations The following table summarizes net revenue from each of the Company’s customers, who individually represent at least 10% The following table summarizes accounts receivable concentrations for each of the Company’s customers, who individuallyrepresent at least 10% of gross total accounts receivable. For DefenCath, the Company currently has one FDA-approved source (contract manufacturing organization, or “CMO”) foreach of its two key active pharmaceutical ingredients (“APIs”), taurolidine and heparin sodium, respectively. With regards totaurolidine, the Company has a drug master file (“DMF”) filed with the FDA. There is a master commercial supply agreement between The Company received FDA approval of DefenCath with finished dosage production from its European based CMO, RoviPharma Industrial Services. The Company believes this CMO has adequate capacity to produce the volumes needed to meet near-termprojected demand for DefenCath. In addition, the Company also qualified Siegfried Hameln as an alter