CorMedix Inc. Reports Third Quarter and Nine Month 2023 Financial Results and Provides Business Update
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Conference Call Scheduled for Today at 4:30 p.m. Eastern Time
BERKELEY HEIGHTS, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- 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 financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events.
Recent Corporate Highlights:
- The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.
- CorMedix has intensified preparations for commercial launch with a number of new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance.
- In the event CorMedix receives final FDA approval over the coming days, the Company is targeting a commercial launch before the end of the first quarter of 2024.
- The United States Patent and Trademark Office (USPTO) issued a patent with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This Patent reflects the unique and proprietary nature of DefenCath®, and will extend the Company’s intellectual property protection with an expiration date of April 15, 2042.
- Cash and short-term investments, excluding restricted cash, at September 30, 2023 amounted to
$86.6 million .
Joe Todisco, CorMedix CEO, commented, “I am very pleased with the Company’s progress on all fronts, most notably the outcomes of the preapproval inspections at our primary CMO facility and other key vendors, as well as our preparations toward commercial readiness. We have accelerated multiple work streams aimed at commercial launch, and made a number of key hires over the past quarter that are essential to ensuring a successful commercial launch following a potential FDA approval of DefenCath. We look forward to providing additional updates over the coming days as we anticipate a response from FDA on or around our target action date.”
Third Quarter and Nine Month 2023 Financial Highlights
For the third quarter of 2023, CorMedix recorded a net loss of
Operating expenses in the third quarter of 2023 increased approximately
For the nine months ended September 30, 2023, CorMedix recorded a net loss of
Operating expenses in the first nine months of 2023 were
Total cash on hand and short-term investments as of September 30, 2023 was
Conference Call Information
The management team of CorMedix will host a conference call and webcast today, November 14, 2023, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:
Domestic: | 1-888-886-7786 |
International: | 1-416-764-8658 |
Conference ID: | 16013968 |
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 developing its lead product DefenCath®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. 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. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. CorMedix received a second Complete Response Letter from the FDA last August related to deficiencies at both its primary contract manufacturer and its supplier of heparin API. After receiving guidance from FDA at a Type A meeting in April of 2023, the NDA for DefenCath was resubmitted. In June of 2023, the resubmitted NDA was accepted for filing by the FDA with a PDUFA target action date of November 15, 2023. 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 potential FDA approval of DefenCath, the timing of a commercial launch of DefenCath, if approved, 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 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 market conditions; the ability to secure final FDA approval for DefenCath and the timing of such approval; the result of FDA preapproval inspections for DefenCath suppliers; CorMedix’s ability to manage its cash resources and the impact on current, planned or future research; the effectiveness of CorMedix’s commercial preparedness activities ahead of the target action date; and that preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials. 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
(617) 430-7576
CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) | ||||||||||||
For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||
2023 | 2022 | 2022 | 2022 | |||||||||
Revenue: | ||||||||||||
Net sales | $ | - | $ | 6,817 | $ | - | $ | 35,706 | ||||
Cost of sales | - | (1,469 | ) | - | (3,328 | ) | ||||||
Gross profit | - | 5,348 | - | 32,378 | ||||||||
Operating Expenses: | ||||||||||||
Research and development | (2,663,976 | (2,339,268 | ) | (10,866,236 | ) | (7,836,327 | ) | |||||
Selling, general and administrative | (7,803,307 | (4,628,014 | ) | (22,422,808 | ) | (14,430,791 | ) | |||||
Total Operating Expenses | (10,467,283 | ) | (6,967,282 | ) | (33,289,044 | ) | (22,267,118 | ) | ||||
Loss From Operations | (10,467,283 | ) | (6,961,934 | ) | (33,289,044 | ) | (22,234,740 | ) | ||||
Other Income (Expense): | ||||||||||||
Total Other Income | 722,929 | 108,213 | 1,703,846 | 156,369 | ||||||||
Loss before income taxes | (9,744,354 | ) | (6,853,721 | ) | (31,585,198 | ) | (22,078,371 | ) | ||||
Tax benefit | - | - | - | 585,617 | ||||||||
Net Loss | (9,744,354 | ) | (6,853,721 | ) | (31,585,198 | ) | (21,492,754 | ) | ||||
Other Comprehensive Income (Loss): | ||||||||||||
Total Other Comprehensive (Loss) Income | (6,298 | ) | 6,253 | 1,656 | (41,358 | ) | ||||||
Comprehensive Loss | $ | (9,750,652 | ) | $ | (6,847,468 | ) | $ | (31,583,542 | ) | $ | (21,534,112 | ) |
Net Loss Per Common Share – Basic and Diluted | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.65 | ) | $ | (0.54 | ) |
Weighted Average Common Shares Outstanding – Basic and Diluted | 56,553,174 | 41,183,585 | 48,715,585 | 39,741,555 |
CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET DATA (Unaudited) | ||||||
September 30, | December 31, | |||||
2022 | 2022 | |||||
ASSETS | ||||||
Cash, cash equivalents and restricted cash | $ | 53,501,021 | $ | 43,374,745 | ||
Short-term investments | $ | 33,273,259 | $ | 15,644,062 | ||
Total Assets | $ | 91,429,120 | $ | 62,038,259 | ||
Total Liabilities | $ | 8,227,298 | $ | 6,978,523 | ||
Accumulated deficit | $ | (306,945,984 | ) | $ | (275,360,786 | ) |
Total Stockholders’ Equity | $ | 83,201,822 | $ | 55,059,736 |
CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | |||||||
Nine Month Periods Ended September 30, | |||||||
2023 | 2022 | ||||||
Cash Flows from Operating Activities: | |||||||
Net loss | $ | (31,585,198 | ) | $ | (21,492,754 | ) | |
Net cash used in operating activities | (27,663,786 | ) | (18,201,893 | ) | |||
Cash Flows from Investing Activities: | |||||||
Net cash used in investing activities | (17,659,477 | ) | (3,707,503 | ) | |||
Cash Flows from Financing Activities: | |||||||
Net cash provided by financing activities | 55,449,154 | 11,852,662 | |||||
Net Increase (Decrease) in Cash and Cash Equivalents | 10,126,276 | (10,081,198 | ) | ||||
Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 43,374,745 | 53,551,277 | |||||
Cash and Cash Equivalents and Restricted Cash - End of Period | $ | 53,501,021 | $ | 43,470,079 |
FAQ
What are the recent corporate highlights announced by CorMedix Inc.?
What were the financial results for the third quarter and nine months ended September 30, 2023?