Full Press Release Details
INC. REPORTS fourth QUARTER and full year 2020 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 4:30 p.m. Eastern Time
Heights, NJ - March 30, 2021 - CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced financial
results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent business developments.
Corporate Highlights:
Baluch, CorMedix CEO commented, "While we were disappointed that the DefenCath NDA was not approved at its PDUFA date, we remain
confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce
catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right
team and resources to accomplish this as we advance DefenCath closer to regulatory approval."
Quarter 2020 Financial Highlights
the fourth quarter of 2020, CorMedix recorded a net loss of $6.1 million, or $0.19 per share, compared with a net loss of $5.3 million,
or $0.21 per share, in the fourth quarter of 2019, an increase in net loss of $0.8 million. The increase in net loss in the fourth quarter
of 2020 compared with 2019 was primarily driven by increases in employee costs and market research costs. Operating expenses during the
fourth quarter of 2020 were $6.1 million, compared with $5.4 million in the fourth quarter of 2019, an increase of approximately $0.7
Year 2020 Financial Highlights
the year ended December 31, 2020, CorMedix recorded a net loss of $22.0 million, or $0.77 per share, compared with a net loss during
the year ended December 31, 2019 of $16.4 million before recognition of deemed dividends, or $0.68 per share, an increase in net loss
of $5.6 million. The increase in net loss was driven primarily by increases in operating expenses.
expenses during the year ended December 31, 2020 amounted to $27.3 million compared with $20.9 million during the comparable period in
2019, an increase of $6.4 million, or 30%, due to a 21% increase in R&D expense and 41% increase in SG&A expense.
cash on hand and short-term investments as of December 31, 2020 amounted to $46.3 million, excluding restricted cash of $0.2 million.
The Company believes that, based on the Company's cash resources at year end plus the $41.5 million in net proceeds from ATM issuances
since the beginning of 2021, it has sufficient resources to fund operations at least into the second half of 2022.
management team of CorMedix will host a conference call and webcast today, March 30, 2021, at 4:30 PM Eastern Time, to discuss recent
corporate developments and financial results. Call details and dial-in information is as follows:
March 30th @ 4:30pm ET
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13715664
Webcast: Webcast Link
Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of
infectious and inflammatory 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, which provides 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 intends to develop DefenCath as a catheter lock solution for use in oncology
and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices,
with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop
taurolidine-based therapies for rare pediatric cancers. Neutrolin is CE Marked and marketed in Europe and other territories
as a medical device. For more information, visit: www.cormedix.com.
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, future financial position, financing plans, future revenues and projected costs
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 results of our discussions with the FDA regarding the DefenCath development path for
marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; 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/Neutrolin 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.
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
| For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 55,713 | $ | 24,779 | $ | 239,231 | $ | 283,266 | ||||||||
| Cost of sales | (57,233 | ) | (46,125 | ) | (204,846 | ) | (373,234 | ) | ||||||||
| Gross profit | (1,520 | ) | (21,346 | ) | 34,385 | (89,968 | ) | |||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (2,294,430 | ) | (2,677,007 | ) | (13,377,193 | ) | (11,052,903 | ) | ||||||||
| Selling, general and administrative | (3,788,690 | ) | (2,677,470 | ) | (13,877,944 | ) | (9,865,005 | ) | ||||||||
| Total Operating Expenses | (6,083,120 | ) | (5,354,477 | ) | (27,255,137 | ) | (20,917,908 | ) | ||||||||
| Income (loss) From Operations | (6,084,640 | ) | (5,375,823 | ) | (27,220,752 | ) | (21,007,876 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | 2,940 | 75,788 | 116,065 | 322,668 | ||||||||||||
| Foreign exchange transaction loss | 76 | 2,126 | (59,165 | ) | (21,156 | ) | ||||||||||
| Change in fair value of derivative liability | - | - | - | - | ||||||||||||
| Interest and amortization expense | (5,322 | ) | (6,276 | ) | (33,226 | ) | (787,488 | ) | ||||||||
| Total Other Income (Expense) | (2,306 | ) | 71,638 | 23,674 | (485,976 | ) | ||||||||||
| Net Loss Before Income Taxes | (6,086,946 | ) | (5,304,185 | ) | (27,197,078 | ) | (21,493,852 | ) | ||||||||
| Tax benefit | - | - | 5,169,395 | 5,060,778 | ||||||||||||
| Net Loss | (6,086,946 | ) | (5,304,185 | ) | (22,027,683 | ) | (16,433,074 | ) | ||||||||
| Other Comprehensive Income (Loss) | 2,347 | (4,745 | ) | 4,749 | 735 | |||||||||||
| Comprehensive Income (Loss) | $ | (6,084,599 | ) | $ | (5,308,930 | ) | $ | (22,022,934 | ) | $ | (16,432,339 | ) | ||||
| Net loss | (6,086,946 | ) | (5,304,185 | ) | (22,027,683 | ) | (16,433,074 | ) | ||||||||
| Deemed dividend as a result of warrant modification | - | - | - | (369,500 | ) | |||||||||||
| Deemed dividend as a result of exchange of convertible note and Series C-2, Series D and Series F preferred stock, related party | - | - | - | (26,733,098 | ) | |||||||||||
| Net Loss Attributable to Common Shareholders | (6,086,946 | ) | (5,304,185 | ) | (22,027,683 | ) | (43,535,672 | ) | ||||||||
| Net Income (Loss) Per Common Share - Basic and Diluted | $ | (0.19 | ) | $ | (0.21 | ) | $ | (0.77 | ) | $ | (1.80 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 32,402,336 | 25,665,619 | 28,561,963 | 24,152,088 |
INC. AND SUBSIDIARIES
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 42,096,783 | $ | 16,525,187 | ||||
| Short-term investments | $ | 4,444,072 | $ | 11,984,157 | ||||
| Total Assets | $ | 49,308,303 | $ | 29,475,910 | ||||
| Total Liabilities | $ | 5,085,291 | $ | 5,829,650 | ||||
| Accumulated deficit | $ | (217,448,855 | ) | $ | (195,421,172 | ) | ||
| Total Stockholders' Equity | $ | 44,223,012 | $ | 23,646,260 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| Years Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (22,027,683 | ) | $ | (16,433,074 | ) | ||
| Net cash used in operating activities | (21,967,638 | ) | (15,052,024 | ) | ||||
| Cash Flows Used In Investing Activities: | ||||||||
| Net cash used in (provided by) investing activities | 7,426,176 | (12,020,459 | ) | |||||
| Cash Flows From Financing Activities: | ||||||||
| Net cash provided by financing activities | 40,099,866 | 25,804,362 | ||||||
| Foreign exchange effects on cash | 13,192 | (2,015 | ) | |||||
| Net Increase (Decrease) in Cash and Cash Equivalents | 25,571,596 | (1,270,136 | ) | |||||
| Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 16,525,187 | 17,795,323 | ||||||
| Cash -and Cash Equivalents and Restricted Cash - End of Period | $ | 42,096,783 | $ | 16,525,187 |