Form 8-K - Current report
January 30 2024 - 4:26PM
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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):
January 30, 2024
CORMEDIX INC.
(Exact name of registrant as specified in its
charter)
Delaware |
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001-34673 |
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20-5894890 |
(State or other jurisdiction of
incorporation or organization) |
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(Commission File Number) |
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(I.R.S. Employer
Identification No.) |
300 Connell Drive, Suite 4200
Berkeley Heights, NJ |
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07922 |
(Address of principal executive offices) |
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(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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, $0.001 par value |
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CRMD |
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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
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.
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CORMEDIX INC. |
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|
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Date: January 30, 2024 |
By: |
/s/ Joseph Todisco |
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Name: |
Joseph Todisco |
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Title: |
Chief Executive Officer |
2
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 26th 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 1st, 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
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