Full Press Release Details
Inc. Reports First Quarter 2023 Financial Results and Provides Business Update
Call Scheduled for Today at 4:30 p.m. Eastern Time
NJ - May 15, 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 first quarter ended March 31, 2023 and provided an update on recent business developments.
Recent Corporate Highlights:
Joe Todisco, CorMedix
CEO, commented, "we are excited to announce today that our DefenCath NDA is ready to be resubmitted to FDA. The resubmission reflects
the hard work of the CorMedix regulatory and technical teams and our strategic partners, and we will now increase our focus on preparations
for a potential commercial launch in early 2024. We look forward to providing additional updates as we progress toward potential approval
in 2023 and aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous
First Quarter 2023 Financial Highlights
For the first quarter of 2023, CorMedix recorded
a net loss of $10.6 million, or $0.24 per share, compared with a net loss of $7.0 million, or $0.18 per share, in the first quarter of
2022, an increase of $3.5 million, driven primarily by an increase in operating expenses.
Operating expenses in the first quarter 2023 were
$11.0 million, compared with $7.0 million in the first quarter of 2022, an increase of approximately 57%. The increase was driven
by higher SG&A expenses which increased approximately 60% to $7.6 million, primarily driven by costs related to market research studies
and pre-launch activities in preparation for the potential approval of DefenCath, and an increase in personnel expenses and non-cash charges
for stock-based compensation. R&D expenses also increased by 49% to $3.4 million, primarily due to net increases in personnel expenses
and non-cash charges for stock-based compensation. Additionally, there were also increases in medical affairs activities in preparation
for the potential marketing approval of DefenCath and costs related to the manufacturing of DefenCath prior to its potential marketing
The Company reported cash and short-term investments
of $55.6 million at March 31, 2023, excluding restricted cash. The Company believes that it has sufficient resources to fund operations
at least through the first half of 2024.
Conference Call Information
The management team of
CorMedix will host a conference call and webcast today, May 15, 2023, at 4:30PM Eastern Time, to discuss recent corporate developments
and financial results. Call details and dial-in information are as follows:
Monday, May 15th @ 4:30pm ET
| Domestic: | 1-877-423-9813 |
| International: | 1-201-689-8573 |
| Conference ID: | 13729290 |
| 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 and antifungal 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. The Company 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. The Company conducted a Type A meeting with FDA in April of 2023 and received guidance to support resubmission of the
NDA for DefenCath in mid-May of 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, statements regarding the ability of the Company's DefenCath NDA resubmission to be classified as
Class 2 and the timing of review, 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. Readers are cautioned
that actual results may differ materially from projections or estimates due to a variety of important factors, including: the resources
needed to secure approval of the NDA for DefenCath from the FDA; the risks and uncertainties of the relationships with the additional
CMO and supplier of heparin; the ability to submit a supplement to CorMedix's NDA; the ability to secure final FDA approval prior
to July 1, 2024; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact
on current, planned or future research; obtaining additional financing to support CorMedix's research and development and clinical
activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent
studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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 March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | ||||||||
| Net sales | $ | - | $ | 7,636 | ||||
| Cost of sales | - | (1,527 | ) | |||||
| Gross profit | - | 6,109 | ||||||
| Operating Expenses | ||||||||
| Research and development | (3,407,502 | ) | (2,287,587 | ) | ||||
| Selling, general and administrative | (7,609,677 | ) | (4,750,883 | ) | ||||
| Total operating expenses | (11,017,179 | ) | (7,038,470 | ) | ||||
| Loss from Operations | (11,017,179 | ) | (7,032,361 | ) | ||||
| Other Income (Expense) | ||||||||
| Total other income (expense) | (449,953 | ) | (1,833 | ) | ||||
| Net Loss | (10,567,226 | ) | (7,034,194 | ) | ||||
| Other Comprehensive Income (Loss) | ||||||||
| Total other comprehensive income (loss) | 18,489 | (37,209 | ) | |||||
| Other Comprehensive Loss | $ | (10,548,737 | ) | $ | (7,071,403 | ) | ||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.24 | ) | $ | (0.18 | ) | ||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 44,090,998 | 38,247,059 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 25,496,744 | $ | 43,374,745 | ||||
| Short-term investments | $ | 30,332,493 | $ | 15,644,062 | ||||
| Total Assets | $ | 59,233,659 | $ | 62,038,259 | ||||
| Total Liabilities | $ | 5,305,905 | $ | 6,978,523 | ||||
| Accumulated deficit | $ | (285,928,012 | ) | $ | (275,360,786 | ) | ||
| Total Stockholders' Equity | $ | 53,927,754 | $ | 55,059,736 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (10,567,226 | ) | $ | (7,034,194 | ) | ||
| Net cash used in operating activities | (10,393,886 | ) | (6,744,342 | ) | ||||
| Cash Flows Used in Investing Activities: | ||||||||
| Net cash used in investing activities | (14,686,805 | ) | (4,187,661 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Net cash provided by financing activities | 7,200,406 | 3,004,216 | ||||||
| Net Decrease in Cash and Cash Equivalents | (17,878,001 | ) | (7,930,966 | ) | ||||
| 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 | $ | 25,496,744 | $ | 45,620,311 |