? Q1 2026 Net Revenue of
? Q1 2026 Net Income of
? Company raises FY 2026 Revenue and Adjusted EBITDA Guidance ?
? Conference Call Scheduled for Today at
Recent Corporate Highlights:
CorMedix announces$127.4 million of net revenue for the first quarter of 2026, reflecting strong first quarter execution and positive underlying demand trends. The Company also recognized net income of$38.6 million and adjusted EBITDA of$70.0 million .(1) Basic and fully diluted EPS were$0.48 and$0.43 per share, respectively, for the quarter.- DefenCath® (taurolidine and heparin) sales contributed
$97.5 million of net revenue in the quarter, bolstered by higher utilization of DefenCath by outpatient dialysis customers as well as a non-recurring$9.0 million favorable change in estimate related to certain sales allowances. The acquired Melinta portfolio contributed$29.9 million , reflecting typical, first quarter purchasing patterns for the anti-infective portfolio. CorMedix updates previously established guidance for 2026 net revenue and adjusted EBITDA. The Company increases full-year 2026 net revenue guidance to a range of$325 to$345 million , and full-year adjusted EBITDA guidance to a range of$115 to$135 million .- On
April 27, 2026 ,CorMedix announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation.CorMedix is actively working together with its global partner to prepare for FDA submission of the sNDA, expected in the second half of this year, and targeting for a potential commercial launch for the expanded indication in 2027. - The ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients and is currently trending to completion in 2028. The Company is taking appropriate steps to accelerate enrollment trajectory, including the opening of new study sites and the submission of a protocol amendment to FDA, which, if approved, would remove certain exclusion criteria and broaden patient enrollment.
- Cash and short-term investments, excluding restricted cash, at
March 31, 2026 totaled$178.1 million .
(1) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.
First Quarter 2026 Financial Highlights
For the first quarter of 2026,
Total operating expenses in the first quarter of 2026 were
Research and development (R&D) expenses in the first quarter of 2026 were
Selling and marketing expense increased approximately 180% to
General and administrative expenses increased approximately 124% to
The Company reported cash and cash equivalents of
Conference Call Information
The management team of
| Domestic: | 1-844-676-2922 |
| International: | 1-412-634-6840 |
| Webcast: | Webcast Link |
About
CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in
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, as amended (the “Exchange Act”), 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,” “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 including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; synergy estimates and timing; accretion estimates; Adjusted EBITDA estimates; the risk that topline data from CorMedix’s and its partners’ clinical trials, including the ReSPECT study, that
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, which 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:
Managing Director
daniel@lifesciadvisors.com
(617) 430-7576
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Per Share Data) (Unaudited) | ||||||
| For the Three Months Ended | ||||||
| 2026 | 2025 | |||||
| Revenue: | ||||||
| Product sales, net | $ | 121,916 | $ | 39,082 | ||
| Contract revenue | 5,511 | - | ||||
| Total Revenue | $ | 127,427 | $ | 39,082 | ||
| Cost of sales (exclusive of amortization of intangibles) | $ | 12,005 | $ | 1,545 | ||
| Amortization of intangibles | 10,300 | 52 | ||||
| Gross profit | $ | 105,122 | $ | 37,485 | ||
| Operating Expenses: | ||||||
| Research and development | $ | 7,212 | $ | 3,193 | ||
| Selling and marketing | 12,532 | 4,474 | ||||
| General and administrative | 21,720 | 9,693 | ||||
| Total Operating Expenses | $ | 41,464 | $ | 17,360 | ||
| Income From Operations | $ | 63,658 | $ | 20,125 | ||
| Other (Expense) Income: | ||||||
| Unrealized loss on marketable security | $ | (3,546 | ) | $ | - | |
| Change in contingent consideration | (4,199 | ) | - | |||
| Other non-operating (expense) income, net | (268 | ) | 519 | |||
| Total Other (Expense) Income | $ | (8,013 | ) | $ | 519 | |
| Income before income taxes | $ | 55,645 | $ | 20,644 | ||
| Tax expense | 17,044 | — | ||||
| Net Income | $ | 38,601 | $ | 20,644 | ||
| Net Income Per Common Share – Basic | $ | 0.48 | $ | 0.32 | ||
| Net Income Per Common Share - Diluted | $ | 0.43 | $ | 0.30 | ||
| Weighted Average Common Shares Outstanding – Basic | 79,509 | 65,244 | ||||
| Weighted Average Common Shares Outstanding – Diluted | 92,985 | 68,975 | ||||
CONDENSED CONSOLIDATED BALANCE SHEET DATA (In Thousands) | ||||||
| 2026 | 2025 | |||||
| (Unaudited) | (Audited) | |||||
| ASSETS | ||||||
| Cash and cash equivalents | $ | 178,087 | $ | 144,837 | ||
| Short-term investments | $ | — | $ | 3,694 | ||
| Trade receivables, net | $ | 154,807 | $ | 171,233 | ||
| Inventories | $ | 30,731 | $ | 29,716 | ||
| $ | 398,774 | $ | 409,074 | |||
| Deferred tax assets | $ | 3,312 | $ | 16,276 | ||
| Other current and long-term assets | $ | 49,926 | $ | 51,312 | ||
| Total Assets | $ | 815,637 | $ | 826,142 | ||
| Total Liabilities | $ | 378,588 | $ | 420,835 | ||
| Stockholders' Equity | $ | 437,049 | $ | 405,307 | ||
| Total Liabilities and Stockholders’ Equity | $ | 815,637 | $ | 826,142 | ||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) (Unaudited) | |||||||
| For the Three Months Ended | |||||||
| 2026 (Unaudited) | 2025 (Unaudited) | ||||||
| Cash Flows from Operating Activities: | |||||||
| Net income | $ | 38,601 | $ | 20,644 | |||
| Net cash provided by (used in) operating activities | $ | 42,382 | $ | 19,737 | |||
| Net cash (used in) provided by investing activities | $ | 2,965 | $ | (195 | ) | ||
| Net cash provided by financing activities | $ | (12,097 | ) | $ | 6,093 | ||
| Net Increase (Decrease) in Cash and Cash Equivalents | $ | 33,250 | $ | 25,635 | |||
| Cash, Cash Equivalents and Restricted Cash - Beginning of Period | $ | 145,825 | $ | 40,756 | |||
| Cash, Cash Equivalents and Restricted Cash - End of Period | $ | 179,075 | $ | 66,391 | |||
Non-GAAP Reconciliations (In Thousands) (Unaudited) | ||||||||
| For the Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Net income | $ | 38,601 | $ | 20,644 | ||||
| Adjusted to add (deduct): | ||||||||
| Interest (income) expense, net | 182 | (557 | ) | |||||
| Provision for income taxes | 17,044 | — | ||||||
| Depreciation and amortization | 10,544 | 162 | ||||||
| EBITDA (Non-GAAP) | $ | 66,371 | $ | 20,249 | ||||
| Adjusted to add (deduct): | ||||||||
| Change in estimate for sales allowances | (8,983 | ) | — | |||||
| Stock-based compensation expense | 4,582 | 3,500 | ||||||
| Merger-related and reorganization costs | 183 | (146 | ) | |||||
| Other (income) expense | 7,831 | 38 | ||||||
| Adjusted EBITDA (Non-GAAP) | $ | 69,984 | $ | 23,641 | ||||
