Form 8-K

8-K — CorMedix Inc.

Accession: 0001410098-26-000020

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001410098

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — crmd-20260514.htm (Primary)

EX-99.1 (crmd_q12026earningspr.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2026

CORMEDIX INC.

(Exact name of registrant as specified in its charter)

Delaware 001-34673 20-5894890

(State or other jurisdiction of

incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

389 Interpace Parkway, Suite 450

Parsippany, NJ

07054

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (908) 517-9500

300 Connell Drive, Suite 4200, Berkeley Heights, NJ 07922

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2, below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common stock, $0.001 par value CRMD Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition

On May 14, 2026, CorMedix Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No. Description

99.1

Press Release dated May 14, 2026

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CORMEDIX INC.

May 14, 2026

/s/ Joseph Todisco

Name: Joseph Todisco

Title: Chief Executive Officer

EX-99.1

Filename: crmd_q12026earningspr.htm · Sequence: 2

Document

Exhibit 99.1

CORMEDIX THERAPEUTICS REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

‒ Q1 2026 Net Revenue of $127.4 million ‒

‒ Q1 2026 Net Income of $38.6 million; Adjusted EBITDA of $70.0 million ‒

‒ Company raises FY 2026 Revenue and Adjusted EBITDA Guidance ‒

‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒

Parsippany, NJ – May 14, 2026 – CorMedix Therapeutics (Nasdaq: CRMD) today announced financial results for the first quarter ended March 31, 2026 and provided an update on its business.

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.

Joseph Todisco, CorMedix Chairman & CEO, commented, “CorMedix has entered 2026 with strong momentum across all areas of our business. DefenCath continues to exceed expectations despite pending TDAPA expiration and demonstrates strong underlying utilization demand. In addition, we are advancing a pipeline of late-stage opportunities, including REZZAYO for prophylaxis, which we expect will meaningfully expand our long-term revenue opportunity. Lastly, we have delivered significant profitability and cash generation, allowing us to reinvest in growth, as well as shareholder value creation through stock repurchases, while preserving financial flexibility for new business development initiatives."

(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, CorMedix recorded $127.4 million in net revenue, comprised of $97.5 million in sales of DefenCath and $29.9 million in revenue associated with the acquired Melinta portfolio, an increase from $39.1 million in net revenue in the comparable period of 2025. DefenCath sales in the quarter were positively impacted by a non-recurring $9.0 million change in estimate related to certain sales allowances. DefenCath sales increased year over year largely due to the onboarding of a large dialysis organization in mid-2025. As the Melinta acquisition occurred in August 2025, the first quarter of 2025 included net revenue from only sales of DefenCath.

Total operating expenses in the first quarter of 2026 were $41.5 million, compared with $17.4 million in the first quarter of 2025, an increase of approximately 139%. The increase of $24.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company.

Research and development (R&D) expenses in the first quarter of 2026 were $7.2 million, compared with $3.2 million for the same period in 2025. The increase in R&D was primarily due to an increase in personnel and clinical trial services in support of the ongoing clinical programs,

including pediatric studies for several of our brands and the continued investment in the development of DefenCath for the TPN indication.

Selling and marketing expense increased approximately 180% to $12.5 million in first quarter of 2026 from $4.5 million in the first quarter of 2025. The increase was primarily due to higher personnel cost associated with the larger product portfolio and related marketing programs.

General and administrative expenses increased approximately 124% to $21.7 million in the first quarter of 2026 from $9.7 million in the first quarter of 2025. The increase was primarily attributable to higher costs associated with operating as a combined company following the acquisition, including higher personnel, information technology, branded prescription drug, legal and facilities costs.

CorMedix recorded net income of $38.6 million, or $0.48 and $0.43 per basic and diluted share, respectively, in the first quarter of 2026, compared with net income of $20.6 million, or $0.32 and $0.30 per basic and diluted share, respectively, in the first quarter of 2025. Also for the first quarter of 2026, CorMedix reported adjusted EBITDA of $70.0 million, compared to adjusted EBITDA of $23.6 million in the first quarter of 2025.

The Company reported cash and cash equivalents of $178.1 million at March 31, 2026, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 14, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

May 14, 2026 @ 8:30am ET

Domestic: 1-844-676-2922

International: 1-412-634-6840

Webcast: Webcast Link

About CorMedix

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 the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. 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, 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 CorMedix announces or publishes from time to time may change as more patient data become available or may be interpreted differently if additional data is disclosed; estimates of total addressable market size; expectations regarding product utilization and sales; failure to successfully conduct future clinical trials, including due to CorMedix’s or its partners’ potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to CorMedix’s product candidates; expectations and timing regarding clinical trials and development and expectations of CorMedix’s product pipeline; expectations regarding implementation and perceived benefits of CorMedix’s products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals; and reporting obligations related thereto, the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products. 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 most recent Annual Report on Form 10-K, 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. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. 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 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:

Dan Ferry

Managing Director

LifeSci Advisors

daniel@lifesciadvisors.com

(617) 430-7576

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Per Share Data)

(Unaudited)

For the Three Months Ended

March 31,

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

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

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(In Thousands)

March 31

December 31,

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

Goodwill and intangible assets

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

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In Thousands)

(Unaudited)

For the Three Months Ended

March 31,

2026

2025

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

CORMEDIX INC. AND SUBSIDIARIES

Non-GAAP Reconciliations

(In Thousands)

(Unaudited)

For the Three Months Ended

March 31,

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

Adjusted EBITDA (Non-GAAP)

69,984

23,641

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration