Form 8-K - Current report

 

 

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): January 7, 2025

 

 

 

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.)

 

300 Connell Drive, Suite 4200

Berkeley Heights, New Jersey 07922

(Address of Principal Executive Offices) (Zip Code)

 

[phone]

Registrant’s telephone number, including area code

 

N/A

(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:

 

☐	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 Exchange Act:

 

(Title of each class)		(Trading Symbol)		(Name of 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 January 7, 2025, CorMedix Inc. (the “Company”) issued a press release announcing its preliminary financial results for the quarter and year ended December 31, 2024 and provided a business update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Item 2.02, including the press release attached hereto as Exhibit 99.1, is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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 (the “Securities Act”), or the Exchange Act, except as shall be 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 issued by CorMedix Inc., dated January 7, 2025.
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

- 1 -

 

 

SIGNATURES

 

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.

 

Date: January 7, 2025	CORMEDIX INC.
	By:	/s/ Joseph Todisco
		Joseph Todisco
		Chief Executive Officer

 

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Exhibit 99.1

 

 

CorMedix Inc. announces preliminary Fourth quarter 2024 results and provides business update

 

‒ Q4 2024 Unaudited Net Revenue of Approximately $31mm ‒

 

‒ FY 2024 Unaudited Net Revenue of Approximately $43mm ‒

 

‒ Expects Q4 Adjusted EBITDA to Exceed $12mm ‒

 

Berkeley Heights, NJ – January 7, 2025 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter results and provides an update on its business. These include the following key updates:

 

●

CorMedix announces preliminary, unaudited net revenue of approximately $31mm for Q4 2024 and approximately $43mm for FY 2024, and expects Q4 2024 adjusted EBITDA(1) to exceed $12mm.

 

●

The Company is shipping DefenCath to all three of its midsized dialysis operator (MDO) customers and has seen continuous ordering of increasing size throughout the quarter. CorMedix has more than $25mm of existing open purchase orders scheduled for delivery during the first quarter of 2025.

 

●

The CorMedix team is actively working with its Large Dialysis Operator (LDO) customer to begin DefenCath implementation in the first half of 2025, and hopes to achieve the LDO’s targeted patient utilization of 4,000 patients in H2 2025.

 

●

The Company today announces an expanded deployment effort in the inpatient hospital segment beginning in Q1 2025. The Company has engaged Syneos Health to build a dedicated inpatient field sales team that will exclusively promote DefenCath to hospitals and health systems. As part of this expanded inpatient deployment, the current field team which was covering both inpatient and outpatient segments is being reorganized, with existing field roles being transitioned or eliminated.

 

●

A final clinical study protocol for DefenCath in Total Parenteral Nutrition (TPN) was submitted to FDA in Q4, and study enrollment is expected to begin in H1 2025. The Company also expects patient enrollment in the pediatric study for DefenCath in pediatric hemodialysis to begin in H2 2025.

 

 

 

 

●

CorMedix estimates the expanded inpatient deployment and internal commercial realignment to be cost neutral on overall S&M expense in 2025, and announces preliminary operating expense guidance for FY 2025 of $72 – $78mm, excluding non-cash and one-time items, with the increase over 2024 spending levels largely driven by R&D spending on previously announced clinical initiatives.

 

●

The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2024, of approximately $52 million.

 

Joe Todisco, CorMedix CEO, commented, “I’m proud to announce our preliminary Q4 results today, including surpassing our guidance of becoming breakeven by year-end 2024. CorMedix continues to execute well on our key objectives particularly around our outpatient launch, and I am pleased with the implementation efforts we have seen thus far from key customers in the outpatient segment. Today’s announcement of our agreement for inpatient expansion with Syneos Health reinforces our commitment to grow DefenCath across settings of care. I believe we begin 2025 in a strong position and look forward to updating investors as we continue to execute over the months ahead.”

 

The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures.

 

(1)

Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock based compensation and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2024 financial results. Such reconciliation is not included in this release because we are currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

 

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.

 

2

 

 

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, including expectations regarding CorMedix’s fourth quarter and full year 2024 unaudited net revenue, fourth quarter 2024 adjusted EBITDA, cash and short-term investments as of December 31, 2024 and preliminary operating expense guidance for fiscal year 2025; the timing of expected achievement of the LDO’s targeted patient utilization; the timing of expected study enrollment for a final clinical study protocol for DefenCath in TPN; and the timing of expected patient enrollment in a pediatric study for DefenCath in pediatric hemodialysis. 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.

 

Investor Contact:

 

Dan Ferry
Managing Director
LifeSci Advisors

[e-mail]
[phone]

 

3

 

Cover	Jan. 07, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 07, 2025
Entity File Number	001-34673
Entity Registrant Name	CORMEDIX INC.
Entity Central Index Key	0001410098
Entity Tax Identification Number	20-5894890
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	300 Connell Drive
Entity Address, Address Line Two	Suite 4200
Entity Address, City or Town	Berkeley Heights
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07922
City Area Code	908
Local Phone Number	517-9500
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 Par Value
Trading Symbol	CRMD
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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