Full Press Release Details
Inc. Reports THIRD Quarter AND NINE MONTH 2024 Financial Results and Provides Business Update
Q3 2024 Net Revenue of $11.5 million
Commercializing DefenCath with Four of Top Five US Dialysis Providers
Conference Call Scheduled for Today at 8:30 a.m. Eastern Time
NJ - October 30, 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 third quarter and nine months
ended September 30, 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 execute on our launch objectives and increase patient
access to DefenCath across settings of care. Having established patient access at roughly 60% of outpatient dialysis clinics in the US,
I'm optimistic about the opportunity for DefenCath as we shift focus toward 2025. We have several important clinical initiatives
commencing early next year aimed at expanding indications for DefenCath beyond adult hemodialysis, providing an important catalyst for
Third Quarter and Nine Months 2024 Financial
For the third quarter of 2024, CorMedix recorded
$11.5 million in net revenue from sales of DefenCath for the first full quarter sales since DefenCath was launched in 2024. For the third
quarter of 2024, CorMedix recorded a net loss of $2.8 million, or $0.05 per share, compared with a net loss of $9.7 million, or $0.17
per share, in the third quarter of 2023, a decrease of $6.9 million or 72%. The decrease in net loss was driven primarily by the launch
of DefenCath and net sales in the period.
Operating expenses in the third quarter 2024 were
$14.1 million, compared with $10.5 million in the third quarter of 2023, an increase of approximately 34%. The increase was driven
by higher selling and marketing (S&M) and general and administrative (G&A) expenses which increased approximately 66% and 76%,
respectively. These increases were partially offset by a decrease in research and development (R&D) expenses of approximately 73%.
The increases in S&M and G&A were primarily driven by increased marketing efforts and the hiring of sales force, medical affairs
and marketing personnel in support of the commercial launch of DefenCath. 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 primarily in G&A expense during the three months ended September 30, 2024.
For the nine months ended September 30, 2024,
CorMedix recorded a net loss of $31.4 million, or $0.54 per share, compared with a net loss of $31.6 million, or $0.65 per share, in the
same period in 2023, a decrease of $0.2 million, or 0.6%, driven primarily by $12.3 million in net revenue and proceeds received from
the sale of our unused New Jersey net operating losses, offset by an increase in operating expenses.
Operating expenses in the first nine months of
2024 were $45.5 million, compared to $33.3 million during the comparative period in 2023, an increase of approximately 37%. This
increase was primarily due to costs related to marketing and commercial activities in support of the launch activities of DefenCath, partially
offset by a decrease in R&D expenses, attributable to the marketing approval of DefenCath.
The Company reported cash and short-term investments
of $46.0 million as of September 30, 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 for the quarter ended September 30,
Conference Call Information
The management team of
CorMedix will host a conference call and webcast today, October 30, 2024, at 8:30AM Eastern Time, to discuss recent corporate developments
and financial results. Call details and dial-in information are as follows:
Wednesday, October 30th @ 8:30am ET
| Domestic: | 1-844-481-2557 |
| International: | 1-412-317-0561 |
| Webcast: | Webcast Link |
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 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.
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS
AND COMPREHENSIVE LOSS
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | ||||||||||||||||
| Revenue, net | $ | 11,456,115 | $ | - | $ | 12,262,234 | $ | - | ||||||||
| Cost of revenues | (686,598 | ) | - | (2,014,975 | ) | - | ||||||||||
| Gross profit (loss) | 10,769,517 | - | 10,247,259 | - | ||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | (727,119 | ) | (2,663,976 | ) | (2,215,551 | ) | (10,866,236 | ) | ||||||||
| Selling and marketing | (6,748,900 | ) | (4,058,428 | ) | (20,472,961 | ) | (9,955,651 | ) | ||||||||
| General and administrative | (6,580,834 | ) | (3,744,879 | ) | (22,851,144 | ) | (12,467,157 | ) | ||||||||
| Total operating expenses | (14,056,853 | ) | (10,467,283 | ) | (45,539,656 | ) | (33,289,044 | ) | ||||||||
| Loss from Operations | (3,287,336 | ) | (10,467,283 | ) | (35,292,397 | ) | (33,289,044 | ) | ||||||||
| Other Income (Expense) | ||||||||||||||||
| Total other income | 510,524 | 722,929 | 2,503,203 | 1,703,846 | ||||||||||||
| Net Loss Before Income Taxes | (2,776,812 | ) | (9,744,354 | ) | (32,789,194 | ) | (31,585,198 | ) | ||||||||
| Tax benefit | - | - | 1,394,770 | - | ||||||||||||
| Net Loss | (2,776,812 | ) | (9,744,354 | ) | (31,394,424 | ) | (31,585,198 | ) | ||||||||
| Other Comprehensive Income (Loss) | ||||||||||||||||
| Total other comprehensive income (loss) | 3,389 | (6,298 | ) | (4,988 | ) | 1,656 | ||||||||||
| Other Comprehensive (Loss) Income | $ | (2,773,423 | ) | $ | (9,750,652 | ) | $ | (31,399,412 | ) | $ | (31,583,542 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.05 | ) | $ | (0.17 | ) | $ | (0.54 | ) | $ | (0.65 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 58,825,221 | 56,553,174 | 57,986,190 | 48,715,585 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | (Audited) | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 35,391,222 | $ | 43,823,192 | ||||
| Short-term investments | $ | 10,743,562 | $ | 32,388,130 | ||||
| Total Assets | $ | 77,586,194 | $ | 82,059,957 | ||||
| Total Liabilities | $ | 18,873,926 | $ | 11,917,528 | ||||
| Accumulated deficit | $ | (353,094,437 | ) | $ | (321,700,013 | ) | ||
| Total Stockholders' Equity | $ | 58,712,268 | $ | 70,142,429 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (31,394,424 | ) | $ | (31,585,198 | ) | ||
| Net cash used in operating activities | (45,000,117 | ) | (27,663,786 | ) | ||||
| Cash Flows Used in Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities | 21,534,874 | (17,659,477 | ) | |||||
| Cash Flows from Financing Activities: | ||||||||
| Net cash provided by financing activities | 15,033,751 | 55,449,154 | ||||||
| Net (Decrease) Increase in Cash and Cash Equivalents | (8,431,970 | ) | 10,126,276 | |||||
| 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 | $ | 35,391,222 | $ | 53,501,021 |