Full Press Release Details
Inc. Reports First Quarter 2024 Financial Results and Provides Business Update
Call Scheduled for Today at 8:30 a.m. Eastern Time
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:
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
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
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 |
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:
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.
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| 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
| 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
| 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 |