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 30, 2024

CORMEDIX INC.

(Exact name of registrant as specified in its charter)

Delaware

001-34673

20-5894890

(State or other jurisdiction of

incorporation or organization)

(Commission File Number)

(I.R.S. Employer

Identification No.)

300 Connell Drive, Suite 4200

Berkeley Heights, NJ

07922

(Address of principal executive offices)

(Zip Code)

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

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 Exchange 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 8.01 Other Events

On January 30, 2024, CorMedix Inc. (the “Company”) issued a press release announcing updates related to its business and anticipated launch of DefenCath, including that it received a benefit determination from the Center for Medicare & Medicaid Services as described in the attached release.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.		Description

99.1		Press Release dated January 30, 2024.
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.

Date: January 30, 2024	By:	/s/ Joseph Todisco
	Name:	Joseph Todisco
	Title:	Chief Executive Officer

Exhibit 99.1

CORMEDIX INC. announces commercial AND REiMBURSEMENT updates

Berkeley Heights, NJ – January 30, 2024 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced updates related to its business and anticipated launch of DefenCath^®.

Recent Updates:

On January 25, 2024 the Center for Medicare & Medicaid Services (CMS) notified CorMedix that the agency has determined DefenCath will be eligible for reimbursement in accordance with the ESRD PPS. As such, CorMedix is entitled to submit an application for a Transitional Drug Add-On Payment (TDAPA) which currently allows for five years of additional payment reimbursement to outpatient providers. CorMedix submitted its TDAPA application on January 26^th after receiving the CMS notification, and CMS has subsequently confirmed receipt.

As a result of CMS’ determination that DefenCath is within the scope of the ESRD PPS and eligible for TDAPA, CorMedix has established its list price (WAC) of $249.99 per 3ml vial, to account for the market dynamics and functionality of the TDAPA framework. Should CMS make a future determination that DefenCath is eligible for Medicare Part B reimbursement, CorMedix has committed to CMS to reduce the list price accordingly.

●

CorMedix previously applied for and received a New Technology Add-On Payment (NTAP) from CMS for inpatient reimbursement of DefenCath. Now that the company has established a WAC price for commercialization, CorMedix will notify CMS accordingly to make any necessary adjustment to the NTAP reimbursement payment to inpatient facilities.

●

CorMedix reiterates its previously disclosed launch guidance of April 15, 2024 for inpatient commercialization, and a target of July 1, 2024 for the commencement of outpatient commercialization. The outpatient timing is contingent upon CMS approval and implementation of the DefenCath TDAPA application in accordance with the agency’s publicly stated objective that CMS aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS code for the product. If CMS requires additional time for the implementation of TDAPA, outpatient commercialization could be shifted an additional quarter. CorMedix intends to work closely with CMS on the TDAPA implementation process.

Joseph Todisco, CorMedix CEO, commented, “This determination by CMS is in line with our base case expectations, and we are very pleased to have a timely decision from the agency that allows CorMedix to commence commercialization of DefenCath based on the timelines we have communicated. We have received significant inbound interest from both inpatient facilities as well as outpatient dialysis providers as to the utilization of DefenCath, and this reimbursement clarity allows us to move forward with negotiating direct procurement agreements for the product. I look forward to providing additional commercial updates in the upcoming months as CorMedix brings this important novel drug product to market.”

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^®, a novel, non-antibiotic antimicrobial solution approved to reduce the incidence of catheter-related bloodstream infections in the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. DefenCath was approved by the FDA on November 15, 2023 and the Company has indicated an initial inpatient launch date of April 15, 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. 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. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, the commercial launch of DefenCath, including the timing of availability of DefenCath for inpatient and outpatient settings and the ability to staff a field team in time for commercial launch, DefenCath eligibility for TDAPA, CMS implementation of TDAPA on July 1^st, the interest in DefenCath by health systems, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations, including the commercial launch of DefenCath, 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, including: the risks and uncertainties related to the ability to have sufficient DefenCath available for commercial launch, CorMedix’s ability to contract with health systems for the use of DefenCath, market conditions, CorMedix’s ability to manage its cash resources and the impact on current, planned or future research. These and other risks are described in greater detail in CorMedix’s filings with the SEC, 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 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

daniel@lifesciadvisors.com

(617) 430-7576

Cover	Jan. 30, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 30, 2024
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