Full Press Release Details
INC. REPORTS fourth QUARTER and full year 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 8:30 a.m. Eastern Time
Heights, NJ - March 30, 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 fourth quarter and full year ended December 31, 2022 and provided an update on recent business developments.
Recent Corporate Highlights:
Joe Todisco, CorMedix CEO,
commented, "we are very pleased that FDA has granted our meeting request and classified the meeting as a Type A, allowing us to
seek FDA's guidance in mid-April. The CorMedix team has made solid progress on all fronts, working diligently in support of the
primary CMO as it completed the corrective actions to address previously identified deficiencies, as well as continuing to build out the
team, processes and systems to be ready for commercialization as quickly as possible following a potential FDA approval. We have further
refined our parallel supply chain pathways to mitigate risk, with the goal of pursuing FDA approval of DefenCath in 2023. We look forward
to providing additional updates as we aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis
via central venous catheters, and potentially other therapeutic settings."
4th Quarter 2022 Financial
the fourth quarter of 2022, CorMedix recorded a net loss of $8.2 million, or $0.20 per share, compared with a net loss of $7.8 million,
or $0.20 per share, in the fourth quarter of 2021. The increase in net loss in the fourth quarter of 2022 compared with 2021 was primarily
driven by increases in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval
of DefenCath. Operating expenses during the fourth quarter of 2022 were $8.4 million, compared with $7.8 million in the fourth quarter
of 2021, an increase of approximately $0.6 million.
Year 2022 Financial Highlights
the year ended December 31, 2022, CorMedix recorded a net loss of $29.7 million, or $0.74 per share, compared with a net loss during the
year ended December 31, 2021 of $28.2 million, or $0.75 per share. The increase in net loss was driven primarily by increases in operating
expenses during the year ended December 31, 2022 amounted to $30.7 million compared with $29.5 million during the comparable period in
2021, an increase of $1.2 million, or 4%, due to a 22% increase in SG&A expense, offset by a 18% decrease in R&D expense.
and short-term investments as of December 31, 2022 amounted to $58.8 million, excluding restricted cash of $0.2 million. CorMedix received
approximately $7.2 million in net proceeds from ATM issuance during the first quarter of 2023. The Company believes that it has sufficient
resources to fund operations for at least twelve months from the issuance of our Annual Report on Form 10-K.
Conference Call Information
management team of CorMedix will host a conference call and webcast today, March 30, 2023, at 8:30 AM Eastern Time, to discuss recent
corporate developments and financial results. Call details and dial-in information is as follows:
Thursday, March 30th @ 8:30am ET
Domestic: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13736467
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, antibacterial 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 Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing
organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until
satisfactory resolution of facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an
inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for
DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer
the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter
lock solution for use in other patient populations. The Company is also 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 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,
CorMedix's plans to submit a resubmission of its NDA application for DefenCath and the timing of such submission, 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 ability of the CMO to successfully address the deficiencies identified
by the FDA; the ability of the Company's heparin supplier to successfully address the manufacturing deficiencies identified in the
warning letter for non-heparin API; 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, 2023 or obtain CMS approval of a resubmitted NTAP application; the risks and uncertainties
associated with CorMedix's ability to manage its limited cash resources and the impact on current, planned or future research, including
the continued development of DefenCath and research for additional uses for taurolidine; 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. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations.
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.
CORMEDIX INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
| For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 29,702 | $ | 56,397 | $ | 65,408 | $ | 190,936 | ||||||||
| Cost of sales | (406 | ) | (48,007 | ) | (3,734 | ) | (148,938 | ) | ||||||||
| Gross profit (loss) | 29,296 | 8,390 | 61,674 | 41,998 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (2,843,222 | ) | (3,235,219 | ) | (10,679,549 | ) | (13,132,982 | ) | ||||||||
| Selling, general and administrative | (5,575,302 | ) | (4,553,092 | ) | (20,006,093 | ) | (16,346,601 | ) | ||||||||
| Total Operating Expenses | (8,418,524 | ) | (7,788,311 | ) | (30,685,642 | ) | (29,479,583 | ) | ||||||||
| Income (loss) From Operations | (8,389,228 | ) | (7,779,921 | ) | (30,623,968 | ) | (29,437,585 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | 183,506 | 4,367 | 326,016 | 14,403 | ||||||||||||
| Foreign exchange transaction gain (loss) | 5,547 | (10,055 | ) | 37,145 | (21,287 | ) | ||||||||||
| Interest expense | (8,776 | ) | (5,378 | ) | (26,515 | ) | (15,943 | ) | ||||||||
| Total Other Income (Expense) | 180,277 | (11,066 | ) | 336,646 | (22,827 | ) | ||||||||||
| Net Loss Before Income Taxes | (8,208,951 | ) | (7,790,987 | ) | (30,287,322 | ) | (29,460,412 | ) | ||||||||
| Tax benefit | - | - | 585,617 | 1,250,186 | ||||||||||||
| Net Loss | (8,208,951 | ) | (7,790,987 | ) | (29,701,705 | ) | (28,210,226 | ) | ||||||||
| Other Comprehensive Income (Loss) | 36,971 | (8,372 | ) | (4,387 | ) | (14,876 | ) | |||||||||
| Comprehensive Loss | $ | (8,171,980 | ) | $ | (7,799,359 | ) | $ | (29,706,092 | ) | $ | (28,225,102 | ) | ||||
| Net Income (Loss) Per Common Share - Basic and Diluted | $ | (0.20 | ) | $ | (0.20 | ) | $ | (0.74 | ) | $ | (0.75 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 41,855,056 | 38,113,514 | 40,274,273 | 37,666,081 |
CORMEDIX INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 43,374,745 | $ | 53,551,277 | ||||
| Short-term investments | $ | 15,644,062 | $ | 12,149,003 | ||||
| Total Assets | $ | 62,038,259 | $ | 68,945,576 | ||||
| Total Liabilities | $ | 6,978,523 | $ | 6,147,509 | ||||
| Accumulated deficit | $ | (275,360,786 | ) | $ | (245,659,081 | ) | ||
| Total Stockholders' Equity | $ | 55,059,736 | $ | 62,798,067 |
CORMEDIX INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (29,701,705 | ) | $ | (28,210,226 | ) | ||
| Net cash used in operating activities | (24,356,732 | ) | (21,155,223 | ) | ||||
| Cash Flows Used In Investing Activities: | ||||||||
| Net cash used in investing activities | (3,709,364 | ) | (9,134,915 | ) | ||||
| Cash Flows From Financing Activities: | ||||||||
| Net cash provided by financing activities | 17,898,241 | 41,757,551 | ||||||
| Foreign exchange effects on cash | (8,677 | ) | (12,919 | ) | ||||
| Net (Decrease) Increase in Cash and Cash Equivalents | (10,176,532 | ) | 11,454,494 | |||||
| Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 53,551,277 | 42,096,783 | ||||||
| Cash -and Cash Equivalents and Restricted Cash - End of Period | $ | 43,374,745 | $ | 53,551,277 |