Full Press Release Details
CORMEDIX INC. REPORTS THIRD QUARTER
2021 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 4:30 p.m. Eastern Time
Heights, NJ - November 9, 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 third quarter and nine months ended September 30, 2021 and provided an update on recent developments.
and Regulatory Highlights:
Matt David, CorMedix interim CEO, commented, "We are pleased that we have been able to resume manufacturing activities at our CMO
and look forward to providing updates over the coming months. As the recent industry conference presentations have highlighted, catheter
related bloodstream infections are common in patients receiving hemodialysis via central venous catheters and are associated with significant
morbidity and mortality. We remain steadfast in our commitment to these patients as we seek to bring DefenCath to market upon its approval."
and Nine Month 2021 Financial Highlights
the third quarter of 2021, CorMedix recorded a net loss of $8.6 million, or $0.22 per share, compared with a net loss of $6.6 million,
or $0.22 per share, in the third quarter of 2020. The higher net loss recognized during the third quarter of 2021 compared with 2020
was due to the net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval.
expenses in the third quarter of 2021 increased approximately 30% to $8.6 million, compared with $6.6 million in the third quarter of
2020. R&D expense increased approximately 62% to $4.7 million compared to $2.9 million in the third quarter of 2020, mainly due to
net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased
approximately 4% to $3.8 million compared with $3.7 million in the third quarter of 2020. This increase was driven primarily by an increase
in non-cash charges for stock-based compensation and an increase in personnel expenses, partially offset by decreases in costs related
to market research studies in preparation for the potential marketing approval of DefenCath and in consulting fees.
the nine months ended September 30, 2021, CorMedix recorded a net loss of $20.4 million, or $0.54 per share, compared with a net loss
of $15.9 million, or $0.58 per share, in the first nine months of 2020. The increase in net loss in the first nine months of 2021 was
driven primarily by a lower tax benefit from the New Jersey NOL program.
expenses in the first nine months of 2021 were $21.7 million compared with $21.2 million during the comparable period in 2020, an increase
of $0.5 million, or 2%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by
a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing
cash on hand and short-term investments as of September 30, 2021 was $72.0 million, excluding restricted cash of $0.2 million. The Company
believes that, based on the Company's cash resources at September 30, 2021, it has sufficient resources to fund operations at least
through 2022, after taking into consideration the costs for re-submission of the NDA and initial preparations for the commercial launch
management team of CorMedix will host a conference call and webcast today, November 9, 2021, at 4:30 PM Eastern Time, to discuss recent
corporate developments and financial results. Call details and dial-in information is as follows:
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13723602
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 (QIDP), and the 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 from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract
manufacturing facility, including in-process controls for the filling operation. 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.
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, 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; our ability to address the deficiencies identified at our
CMO in connection with the manufacture of DefenCath; 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.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 38,088 | $ | 93,020 | $ | 134,539 | $ | 183,517 | ||||||||
| Cost of sales | (25,166 | ) | (79,913 | ) | (100,931 | ) | (147,614 | ) | ||||||||
| Gross profit (loss) | 12,922 | 13,107 | 33,608 | 35,903 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (4,741,228 | ) | (2,925,355 | ) | (9,897,763 | ) | (11,082,764 | ) | ||||||||
| Selling, general and administrative | (3,836,613 | ) | (3,691,507 | ) | (11,793,509 | ) | (10,089,252 | ) | ||||||||
| Total Operating Expenses | (8,577,841 | ) | (6,616,862 | ) | (21,691,272 | ) | (21,172,016 | ) | ||||||||
| Loss From Operations | (8,564,919 | ) | (6,603,755 | ) | (21,657,664 | ) | (21,136,113 | ) | ||||||||
| Other Income (Expense) | (4,447 | ) | 3,008 | (11,761 | ) | 25,980 | ||||||||||
| Net Loss Before Income Taxes | (8,569,366 | ) | (6,600,747 | ) | (21,669,425 | ) | (21,110,133 | ) | ||||||||
| Tax Benefit | - | - | 1,250,186 | 5,169,395 | ||||||||||||
| Net Loss | (8,569,366 | ) | (6,600,747 | ) | (20,419,239 | ) | (15,940,738 | ) | ||||||||
| Total other comprehensive income (loss) | (3,679 | ) | (5,931 | ) | (6,504 | ) | 2,402 | |||||||||
| Comprehensive Loss | $ | (8,573,045 | ) | $ | (6,606,678 | ) | $ | (20,425,743 | ) | $ | (15,938,336 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.22 | ) | $ | (0.22 | ) | $ | (0.54 | ) | $ | (0.58 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 38,113,514 | 29,601,412 | 37,515,298 | 27,276,648 |
CONDENSED CONSOLIDATED
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Cash and cash equivalents and restricted cash | $ | 66,552,961 | $ | 42,096,783 | ||||
| Short-term investments | $ | 5,653,202 | $ | 4,444,072 | ||||
| Total Assets | $ | 75,389,223 | $ | 49,308,303 | ||||
| Total Liabilities | $ | 6,045,042 | $ | 5,085,291 | ||||
| Accumulated deficit | $ | (237,868,094 | ) | $ | (217,448,855 | ) | ||
| Total Stockholders' Equity | $ | 69,344,181 | $ | 44,223,012 | ||||
| Total Liabilities and Stockholders' Equity | $ | 75,389,223 | $ | 49,308,303 |
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW DATA
| Nine Month Periods Ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (20,419,239 | ) | $ | (15,940,738 | ) | ||
| Net cash used in operating activities | (15,285,863 | ) | (16,034,152 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities | (2,005,711 | ) | 9,273,640 | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from the public offering, net | - | 21,320,170 | ||||||
| Proceeds from sale of common stock from at-the-market program, net | 41,455,630 | 3,045,730 | ||||||
| Proceeds from exercise of warrants | 164,886 | 411,751 | ||||||
| Proceeds from exercise of stock options | 137,035 | - | ||||||
| Net cash provided by financing activities | 41,757,551 | 24,777,651 | ||||||
| Net Increase in Cash | 24,456,178 | 18,022,265 | ||||||
| Cash - Beginning of Period | 42,096,783 | 16,525,187 | ||||||
| Cash - End of Period | $ | 66,552,961 | $ | 34,547,452 |