Full Press Release Details
INC. REPORTS THIRD QUARTER AND NINE MONTH 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 4:30 p.m. Eastern Time
NJ - November 14, 2023 - 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:
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
For the third quarter
of 2023, CorMedix recorded a net loss of $9.7 million, or $0.17 per share, compared with a net loss of $6.9 million, or $0.17 per share,
in the third quarter of 2022. The higher net loss recognized during the third quarter of 2023 compared with 2022 was attributable to net
increase in operating expenses primarily due to increased pre-launch commercial activities for DefenCath.
Operating expenses in
the third quarter of 2023 increased approximately 50% to $10.5 million, compared with $7.0 million in the third quarter of 2022. R&D
expense increased approximately 14% to $2.7 million compared to $2.3 million in the third quarter of 2022, mainly due to a net increase
in costs related to medical affairs activities and increase in personnel related expenses due to additional hires in 2023 as compared
with 2022. SG&A expense increased approximately 69% to $7.8 million compared with $4.6 million in the third quarter of 2022. This
increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for
the potential marketing approval of DefenCath and as a result of additional hires in 2023 as compared with 2022.
For the nine months ended
September 30, 2023, CorMedix recorded a net loss of $31.6 million, or $0.65 per share, compared with a net loss of $21.5 million, or $0.54
per share, in the first nine months of 2022. The increase in net loss in the first nine months of 2023 was driven primarily by an increase
in operating expenses.
Operating expenses in
the first nine months of 2023 were $33.3 million compared with $22.3 million during the comparable period in 2022, an increase of approximately
49%. This increase was primarily attributable to costs related to market research studies and pre-launch activities in preparation for
the potential marketing approval of DefenCath, and an increase in personnel expenses due to additional hires in 2023.
Total cash on hand and
short-term investments as of September 30, 2023 was $86.6 million, excluding restricted cash of $0.2 million. The Company believes that,
based on the Company's cash resources at September 30, 2023, it has sufficient resources to fund operations at least twelve months
from the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.
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 |
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.
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| 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
| 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
| 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 |