CorMedix(US:CRMD)2024-05-09 12:00Part I Financial Information Unaudited Condensed Consolidated Financial Statements CorMedix reported an increased net loss in Q1 2024, driven by higher SG&A for DefenCath's launch, with total assets decreasing to $68.0 million Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $35,180,529 | $43,642,684 | | Short-term investments | $23,370,989 | $32,388,130 | | Inventories | $2,320,396 | $2,106,345 | | License intangible asset | $2,000,000 | $0 | | Total Assets | $68,023,742 | $82,059,957 | | Liabilities & Equity | | | | Total Liabilities | $10,011,022 | $11,917,528 | | Total Stockholders' Equity | $58,012,720 | $70,142,429 | | Total Liabilities and Stockholders' Equity | $68,023,742 | $82,059,957 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Revenues, net | $0 | $0 | | Gross loss | ($819) | $0 | | Research and development | ($837) | ($3,407) | | Selling, general and administrative | ($15,048) | ($7,610) | | Loss From Operations | ($16,704) | ($11,017) | | Net Loss | ($14,466) | ($10,567) | | Net Loss Per Common Share | ($0.25) | ($0.24) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Activity | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,310) | ($10,394) | | Net cash provided by (used in) investing activities | $8,945 | ($14,687) | | Net cash (used in) provided by financing activities | ($97) | $7,200 | | Net Decrease in Cash and Cash Equivalents | ($8,463) | ($17,878) | Management's Discussion and Analysis of Financial Condition and Results of Operations CorMedix focuses on DefenCath's U.S. commercialization, with Q1 2024 net loss increasing due to higher SG&A, partially offset by decreased R&D Overview CorMedix is commercializing DefenCath, an FDA-approved antimicrobial catheter lock solution with marketing exclusivity, launched for inpatient use in April 2024 - The FDA approved DefenCath on November 15, 2023, as the first and only FDA-approved antimicrobial CLS in the U.S. to reduce CRBSI in adult hemodialysis patients96 - DefenCath received 10 years of marketing exclusivity (5 years NCE, 5 years GAIN Act) until November 15, 203397 - CMS approved a Transitional Drug Add-On Payment (TDAPA) for DefenCath, effective July 1, 2024, providing five years of additional outpatient reimbursement10899 - The U.S. commercial launch for inpatient use of DefenCath began on April 15, 2024, with the first commercial supply contract signed with ARC Dialysis, LLC107 Results of Operations CorMedix's Q1 2024 net loss increased to $14.5 million due to a 97% rise in SG&A for DefenCath's launch, partially offset by a 75% decrease in R&D expenses Comparison of Operating Results (in thousands) | Account | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Gross loss | ($819) | $0 | N/A | | Research and development | ($838) | ($3,407) | (75)% | | Selling, general and administrative | ($15,048) | ($7,610) | 98% | | Loss from operations | ($16,705) | ($11,017) | 52% | | Net loss | ($14,467) | ($10,568) | 37% | - SG&A expenses increased by $7.4 million (97%) year-over-year, driven by $3.8 million in personnel costs and $2.7 million for market research and launch activities122 - R&D expenses decreased by $2.6 million (75%) year-over-year, primarily due to reclassification of costs to SG&A and capitalization of manufacturing expenses post-FDA approval121 Liquidity and Capital Resources As of March 31, 2024, CorMedix held $58.6 million in cash and investments, sufficient for at least twelve months of operations, despite increased cash usage for Q1 2024 operating activities - The company's $58.6 million in cash, cash equivalents, and short-term investments as of March 31, 2024, are estimated to fund operations for at least twelve months132136 - Net cash used in operating activities increased to $17.3 million in Q1 2024 from $10.4 million in Q1 2023, driven by a higher net loss and increased working capital for the commercial launch129 - In March 2024, the company received $1.4 million from the sale of its New Jersey net operating losses (NOLs)128 - The company expects to implement an ATM program and may seek additional capital through equity or debt financing to support ongoing funding requirements134 Quantitative and Qualitative Disclosure About Market Risk As a Smaller Reporting Company, CorMedix is not required to provide quantitative and qualitative disclosures about market risk - As a Smaller Reporting Company, CorMedix is not required to provide information regarding quantitative and qualitative disclosures about market risk141 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2024142 - No material changes occurred during the quarter affecting the company's internal control over financial reporting143 Part II Other Information Legal Proceedings The company is defending against a consolidated securities class action and a shareholder derivative lawsuit, both related to DefenCath NDA statements and fiduciary duties - The company is defending a securities class action lawsuit (In re CorMedix Inc. Securities Litigation) alleging violations related to DefenCath NDA statements, with a third amended complaint filed in April 202454145 - A consolidated shareholder derivative action (In re CorMedix Inc. Derivative Litigation) alleging breaches of fiduciary duty is stayed pending the class action lawsuit's motion to dismiss5558 Risk Factors No material changes occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - No material changes occurred from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023146 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities or use of proceeds to report during the period - None147 Exhibits The report includes standard filings such as CEO and CFO certifications under Sarbanes-Oxley Act and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act, along with Inline XBRL documents153