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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 9, 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 2.02 Results of Operations and Financial Condition
On May 9, 2024, CorMedix Inc. (the “Company”)
issued a press release announcing its financial results for the first quarter ended March 31, 2024. 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 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
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: May 9, 2024 |
By: |
/s/ Joseph Todisco |
|
Name: |
Joseph Todisco |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
CorMedix
Inc. Reports First Quarter 2024 Financial Results and Provides Business Update
Conference
Call Scheduled for Today at 8:30 a.m. Eastern Time
Berkeley Heights,
NJ – May 9, 2024 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March
31, 2024 and provided an update on its business.
Recent Corporate Highlights:
| ● | On April 2, 2024, CMS published its HCPCS coding decision for DefenCath, establishing a new HCPCS Level
II code for the product. CMS subsequently notified the Company on April 18th of its determination that DefenCath meets the
criteria for a Transitional Drug Add-On Payment (TDAPA) and will be effective July 1, 2024. The TDAPA program currently provides for five
years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers. |
| ● | On April 15, 2024, the Company commenced commercial launch of DefenCath® in the inpatient setting,
and remains on schedule to commence outpatient launch in July. |
| ● | The Company announced in April that it entered into a 5-year commercial supply contract with ARC Dialysis,
LLC, a Florida-based dialysis provider, for the supply of DefenCath. |
| ● | The FDA granted the Company’s Type C meeting request to discuss an updated development plan for
DefenCath in Total Parenteral Nutrition (TPN) and pediatric study requirements. The Company expects to receive feedback from the FDA by
the end of the second quarter of 2024. |
| ● | The Company submitted to FDA earlier this week a supplement to the CorMedix NDA adding Siegfried Hameln
as an alternate finished dosage manufacturing site for DefenCath. Pending FDA review and approval, the Company anticipates approval of
the supplement by the end of 2024. |
| ● | Cash and short-term investments, excluding restricted cash, at March 31, 2024, amounted to $58.6 million. |
Joe Todisco, CorMedix
CEO, commented, “I am excited about the Company’s recent progress as we have officially transitioned to a commercial stage
organization. In only a few weeks of inpatient deployment we have received meaningful interest in scheduling DefenCath for formulary review
at various institutions, and we look forward to additional progress in the coming months. We are also focusing simultaneously on our upcoming
outpatient launch and actively engaging with customers regarding the potential to implement DefenCath as a preventative measure to reduce
the risk of CRBSI in their respective hemodialysis patients with CVCs.”
First Quarter 2024 Financial Highlights
For the first quarter of 2024, CorMedix recorded
a net loss of $14.5 million, or $0.25 per share, compared with a net loss of $10.6 million, or $0.24 per share, in the first quarter of
2023, an increase of $3.9 million, driven primarily by an increase in operating expenses, partially offset by the sale of New Jersey NOLs
for $1.4 million.
Operating expenses in the first quarter 2024 were
$15.9 million, compared with $11.0 million in the first quarter of 2023, an increase of approximately 44%. The increase was driven
by higher SG&A expenses which increased approximately 98% to $15.0 million, partially offset by a decrease in research and development
expenses of approximately 75%. The increase in SG&A was primarily driven by the hiring of sales force, medical affairs and marketing
personnel. Additionally, as a result of the post FDA approval commercial operations, costs related to medical affairs and certain personnel
expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in selling, general and administrative
expense during the three months ended March 31, 2024, as compared to the same period last year during which these items were recognized
in R&D, which drove the decrease in R&D expenses for this period compared to the same period last year.
The Company reported cash and short-term investments
of $58.6 million at March 31, 2024, 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 9, 2024, at 8:30am Eastern Time, to discuss recent corporate
developments and financial results. Call details and dial-in information are as follows:
Thursday, May 9th @ 8:30am ET |
Domestic: |
1-888-886-7786 |
International: |
1-416-764-8658 |
Conference ID: |
32817785 |
Webcast: |
Webcast Link |
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®, which was approved by the FDA on November 15, 2023 and launched
in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix
also intends to develop DefenCath as a catheter lock solution for use in other patient populations. 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. 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
daniel@lifesciadvisors.com
(617) 430-7576
CorMedix
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
|
|
For the Three
Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Revenue |
|
|
|
|
|
|
Revenue, net |
|
$ |
- |
|
|
$ |
- |
|
Cost of revenues |
|
|
(818,539 |
) |
|
|
- |
|
Gross loss |
|
|
(818,539 |
) |
|
|
- |
|
Operating Expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
(837,445 |
) |
|
|
(3,407,502 |
) |
Selling, general and administrative |
|
|
(15,048,252 |
) |
|
|
(7,609,677 |
) |
Total operating expenses |
|
|
(15,885,697 |
) |
|
|
(11,017,179 |
) |
Loss from Operations |
|
|
(16,704,236 |
) |
|
|
(11,017,179 |
) |
Other Income (Expense) |
|
|
|
|
|
|
|
|
Total other income |
|
|
843,343 |
|
|
|
449,953 |
|
Net Loss Before Income Taxes |
|
|
(15,860,893 |
) |
|
|
(10,567,226 |
) |
Tax benefit |
|
|
1,394,770 |
|
|
|
- |
|
Net Loss |
|
|
(14,466,123 |
) |
|
|
(10,567,226 |
) |
Other Comprehensive Income (Loss) |
|
|
|
|
|
|
|
|
Total other comprehensive (loss) income |
|
|
(10,647 |
) |
|
|
18,489 |
|
Other Comprehensive (Loss) Income |
|
$ |
(14,476,770 |
) |
|
$ |
(10,548,737 |
) |
Net Loss Per Common Share – Basic and Diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.24 |
) |
Weighted Average Common Shares Outstanding – Basic and Diluted |
|
|
57,503,154 |
|
|
|
44,090,998 |
|
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
| |
March 31, | | |
December 31, | |
| |
2023 | | |
2023 | |
| |
| | |
| |
ASSETS | |
| | |
| |
Cash, cash equivalents and restricted cash | |
$ | 35,359,907 | | |
$ | 43,823,192 | |
Short-term investments | |
$ | 23,370,989 | | |
$ | 32,388,130 | |
Total Assets | |
$ | 68,023,742 | | |
$ | 82,059,957 | |
| |
| | | |
| | |
Total Liabilities | |
$ | 10,011,022 | | |
$ | 11,917,528 | |
Accumulated deficit | |
$ | (336,166,136 | ) | |
$ | (321,700,013 | ) |
Total Stockholders’ Equity | |
$ | 58,012,720 | | |
$ | 70,142,429 | |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Three
Months Ended
March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Cash Flows from Operating Activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(14,466,123 |
) |
|
$ |
(10,567,226 |
) |
Net cash used in operating activities |
|
|
(17,310,294 |
) |
|
|
(10,393,886 |
) |
Cash Flows Used in Investing Activities: |
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
8,944,932 |
|
|
|
(14,686,805 |
) |
Cash Flows from Financing Activities: |
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(97,118 |
) |
|
|
7,200,406 |
|
Net Decrease in Cash and Cash Equivalents |
|
|
(8,463,285 |
) |
|
|
(17,878,001 |
) |
Cash and Cash Equivalents and Restricted Cash - Beginning of Period |
|
|
43,823,192 |
|
|
|
43,374,745 |
|
Cash and Cash Equivalents and Restricted Cash - End of Period |
|
$ |
35,359,907 |
|
|
$ |
25,496,744 |
|
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