CorMedix Inc. Reports First Quarter 2025 Financial Results and Provides Business Update
- Achieved profitability with $20.6 million net income vs $14.5 million loss in Q1 2024
- Strong Q1 revenue of $39.1 million from DefenCath sales
- Positive cash flow from operations of $19.7 million
- DefenCath institutional shipments doubled over past three months
- Expects to hit high-end of H1 2025 sales guidance ($62-70 million)
- Healthy cash position of $77.5 million
- Operating expenses increased 9% year-over-year to $17.4 million
- R&D expenses increased significantly from $0.8M to $3.2M
- General and administrative expenses rose 11% to $9.7 million
Insights
CorMedix achieves dramatic financial turnaround with $39.1M revenue and $20.6M profit, representing a fundamental transformation from development to commercial success.
CorMedix's Q1 2025 results represent a remarkable financial transformation. The company reported
The profitability metrics demonstrate strong operational execution with adjusted EBITDA of
Operating expenses increased
The company maintains a healthy balance sheet with
Management's projection that first half 2025 sales will reach the high end of their previously guided
DefenCath's successful commercialization in dialysis centers drives CorMedix's profitability while clinical expansion into TPN patients creates future growth potential.
CorMedix's transition to profitability has been driven by the successful commercialization of DefenCath, particularly in outpatient dialysis settings. The strong adoption indicates market recognition of DefenCath's value proposition in preventing catheter-related bloodstream infections in hemodialysis patients.
The company is executing a two-pronged market penetration strategy. While outpatient dialysis centers have been the primary revenue driver, CorMedix has now fully staffed and trained its dedicated inpatient sales team. The reported doubling of inpatient institutional shipments over the past three months suggests growing traction in this channel, with management expecting continued inpatient growth throughout 2025.
Simultaneously, CorMedix is pursuing indication expansion through a newly commenced Phase 3 study evaluating DefenCath for the reduction of Central Line Associated Blood Stream Infections (CLABSIs) in adult patients receiving Total Parenteral Nutrition (TPN). This represents a strategic expansion beyond the dialysis market into another high-risk patient population where catheter-related infections are a significant concern.
The company's investment in R&D has increased significantly year-over-year, reflecting its commitment to clinical development and potential market expansion. With its first site operational and actively screening patients for the TPN study, CorMedix is positioning DefenCath for potential growth beyond its current indication.
‒ Q1 2025 Net Revenue of
Conference Call Scheduled for Today at 8:30 a.m. Eastern Time
BERKELEY HEIGHTS, NJ., May 06, 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 first quarter ended March 31, 2025 and provided an update on its business.
Recent Corporate Highlights:
- CorMedix announces net sales of
$39.1 million for the first quarter of 2025, largely driven by successful implementation by its outpatient dialysis customers. The Company’s first quarter of 2025 was profitable and cash flow positive, with net income of$20.6 million , adjusted EBITDA of$23.6 million , and cash from operations of$19.7 million . - The Company’s dedicated inpatient sales team is now fully staffed, trained, and operational in the field. DefenCath inpatient institutional shipments have doubled over the past three months and the Company anticipates continued inpatient growth throughout 2025.
- CorMedix commenced its Phase 3 study for the reduction of Central Line Associated Blood Stream Infections (CLABSIs) in adult patients receiving Total Parenteral Nutrition (TPN) through a central venous catheter. The first site is operational and actively screening patients.
- CorMedix expects to be at the high-end of the previously announced first half net sales guidance of
$62 million to$70 million , based on latest order trends and inventory tracking with current purchasing customers. - Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to
$77.5 million .
First Quarter 2025 Financial Highlights
For the first quarter of 2025, CorMedix recorded
Operating expenses in the first quarter of 2025 were
General and administrative expenses increased approximately
The Company reported cash and short-term investments of
Conference Call Information
The management team of CorMedix will host a conference call and webcast today, May 6, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:
| Tuesday, May 6th @ 8:30am ET | ||
| Domestic: | 1-844-676-2922 | |
| International: | 1-412-634-6840 | |
| Conference ID: | 10198548 | |
| 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, 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 facilitates 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 | ||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||
| AND COMPREHENSIVE LOSS | ||||||
| (Unaudited) | ||||||
| For the Three Months Ended March 31, | ||||||
| 2025 | 2024 | |||||
| Revenue | ||||||
| Net sales | $ | 39,081,657 | $ | - | ||
| Cost of revenues | (1,596,715 | ) | (818,539 | ) | ||
| Gross income (loss) | 37,484,942 | (818,539 | ) | |||
| Operating Expenses | ||||||
| Research and development | (3,192,440 | ) | (837,445 | ) | ||
| Selling and marketing | (4,473,840 | ) | (6,337,219 | ) | ||
| General and administrative | (9,693,382 | ) | (8,711,033 | ) | ||
| Total operating expenses | (17,359,662 | ) | (15,885,697 | ) | ||
| Income (Loss) from Operations | 20,125,280 | (16,704,236 | ) | |||
| Other Income (Expense) | ||||||
| Total other income | 518,618 | 843,343 | ||||
| Net Income (Loss) Before Income Taxes | 20,643,898 | (15,860,893 | ) | |||
| Tax benefit | - | 1,394,770 | ||||
| Net Income (Loss) | 20,643,898 | (14,466,123 | ) | |||
| Other Comprehensive Income (Loss) | ||||||
| Total other comprehensive loss | (6,090 | ) | (10,647 | ) | ||
| Other Comprehensive Income (Loss) | $ | 20,637,808 | $ | (14,476,770 | ) | |
| Net Income (Loss) Per Common Share – Basic | $ | 0.32 | $ | (0.25 | ) | |
| Net Income (Loss) Per Common Share – Diluted | $ | 0.30 | $ | (0.25 | ) | |
| Weighted Average Common Shares Outstanding – Basic | 65,244,341 | 57,503,154 | ||||
| Weighted Average Common Shares Outstanding – Diluted | 68,975,418 | 57,503,154 | ||||
| CORMEDIX INC. AND SUBSIDIARIES | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | |||||||
| March 31, | December 31, | ||||||
| 2025 | 2024 | ||||||
| (Unaudited) | (Audited) | ||||||
| ASSETS | |||||||
| Cash, cash equivalents and restricted cash | $ | 66,390,985 | $ | 40,756,138 | |||
| Short-term investments | $ | 11,216,989 | $ | 11,036,857 | |||
| Total Assets | $ | 149,582,766 | $ | 118,845,673 | |||
| Total Liabilities | $ | 34,694,718 | $ | 34,188,723 | |||
| Accumulated deficit | $ | (318,986,135 | ) | $ | (339,630,033 | ) | |
| Total Stockholders’ Equity | $ | 114,888,048 | $ | 84,656,950 | |||
| CORMEDIX INC. AND SUBSIDIARIES | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
| (Unaudited) | |||||||
| For the Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| Cash Flows from Operating Activities: | |||||||
| Net income (loss) | $ | 20,643,898 | $ | (14,466,123 | ) | ||
| Net cash provided by (used in) operating activities | 19,736,503 | (17,310,294 | ) | ||||
| Cash Flows Used in Investing Activities: | |||||||
| Net cash (used in) provided by investing activities | (194,820 | ) | 8,944,932 | ||||
| Cash Flows from Financing Activities: | |||||||
| Net cash provided by (used in) financing activities | 6,092,935 | (97,118 | ) | ||||
| Net Increase (Decrease) in Cash and Cash Equivalents | 25,634,847 | (8,463,285 | ) | ||||
| Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 40,756,138 | 43,823,192 | |||||
| Cash and Cash Equivalents and Restricted Cash - End of Period | $ | 66,390,985 | $ | 35,359,907 | |||
| CORMEDIX INC. AND SUBSIDIARIES | |||||
| Non-GAAP Reconciliations | |||||
| (Unaudited) | |||||
| Three Months Ended March 31, 2025 | |||||
| Net income (loss) | $ | 20,643,898 | |||
| Adjusted to add (deduct): | |||||
| Interest expense (income), net | (556,790 | ) | |||
| Provision for (benefit from) income taxes | - | ||||
| Depreciation and amortization | 161,942 | ||||
| EBITDA (Non-GAAP) | $ | 20,249,050 | |||
| Adjusted to add (deduct): | |||||
| Stock-based compensation expense | 3,500,355 | ||||
| Restructuring expense | (145,976 | ) | |||
| Adjusted EBITDA (Non-GAAP) | $ | 23,603,429 | |||
FAQ
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