Full Press Release Details
INC. REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 4:30 p.m. Eastern Time
NJ - November 5, 2020 - CorMedix Inc. (NYSE American: 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, 2020 and provided an update on recent developments.
Recent Corporate and Regulatory
CorMedix CEO, commented, "We have continued to make progress on our goal of bringing Defencath to the U.S. market as a catheter
lock solution for hemodialysis. We look forward to discussing Defencath with the Antimicrobial Drugs Advisory Committee in January,
ahead of the February 28, 2021 PDUFA date for the product. We also are making necessary preparations for the launch of Defencath
in the U.S. hemodialysis market, following FDA approval. We believe we have the team, the focus, the resources, and a novel catheter
lock solution that will meaningfully improve patient outcomes and are excited about the opportunities in front of us."
Third Quarter and Nine Month 2020
Financial Highlights
quarter of 2020, CorMedix recorded a net loss attributable to common shareholders of $6.6 million, or $0.22 per share, compared
with a net loss of $5.3 million, or $0.22 per share, in the third quarter of 2019, excluding the impact of deemed dividends recognized
in September 2019 as the result of an exchange agreement and warrant modification.
months ended September 30, 2020, CorMedix recorded a net loss attributable to common shareholders of $15.9 million, or $0.58 per
share, compared with a net loss of $11.1 million, or $0.47 per share, in the first nine months of 2019, excluding the impact of
deemed dividends recognized in September 2019 as the result of an exchange agreement and warrant modification. The increase in
net loss in the first nine months of 2020 was driven primarily by increased operating expenses.
expenses during the third quarter of 2020 were $6.6 million, compared with $5.2 million in the third quarter of 2019, an increase
of approximately 28%. This increase was due to a $0.4 million, or 16%, increase in R&D expense and $1.1 million, or 40%,
increase in SG&A expense. Operating expenses during the nine-month period ended September 30, 2020 amounted to $21.2 million
compared with $15.6 million during the comparable period in 2019, an increase of $5.6 million, or 36%, due to a 32% increase in
R&D expense and 40% increase in SG&A for this period. R&D expense for the first nine months of 2020 included approximately
$3.8 million in costs related to the purchase of raw materials and manufacturing of Defencath prior to its potential marketing
approval and also included increased staffing costs. Higher SG&A costs were primarily driven by higher staffing costs as well
as costs related to market research studies in preparation for the potential market approval of Defencath.
In July 2020, CorMedix completed an
underwritten public offering of its common stock, which yielded net proceeds of approximately $21.3 million. The public offering
was made pursuant to an underwriting agreement relating to the issuance and sale of an aggregate of 5,111,110 shares of common
stock, including 666,666 shares of common stock pursuant to the full exercise of the underwriters' option, at a public offering
price of $4.50 per share. During October 2020, CorMedix issued shares under its at-the-market ("ATM") program and realized
net proceeds of approximately $4.6 million.
on hand and short-term investments as of September 30, 2020 amounted to $37.0 million, excluding restricted cash of $0.2 million.
The Company believes that, based on the Company's cash resources at September 30, 2020, and including the net proceeds received
in October 2020 from ATM issuance, it has sufficient resources to fund operations for at least the coming 12 months, including
the costs related to the initial preparations for the commercial launch of Defencath.
Conference Call Information
team of CorMedix will host a conference call and webcast today, November 5, 2020, at 4:30 PM Eastern Time, to discuss recent corporate
developments and financial results. Call details and dial-in information is as follows:
| Domestic: | 800-917-9975 |
| International: | 212-231-2901 |
| Conference ID: | 21971218 |
| 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's NDA has been filed and accepted for priority review
with a PDUFA date of February 28, 2021. 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.
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, including
whether a second Phase 3 clinical trial for Defencath's marketing approval will be required; 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. At this time, we are unable to assess whether, and 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
CONDENSED CONSOLIDATED STATEMENTS OF
AND COMPREHENSIVE LOSS
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 93,020 | $ | 59,530 | $ | 183,517 | $ | 258,488 | ||||||||
| Cost of sales | (79,913 | ) | (79,026 | ) | (147,614 | ) | (327,109 | ) | ||||||||
| Gross profit (loss) | 13,107 | (19,496 | ) | 35,903 | (68,621 | ) | ||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (2,925,355 | ) | (2,520,992 | ) | (11,082,764 | ) | (8,375,896 | ) | ||||||||
| Selling, general and administrative | (3,691,507 | ) | (2,631,027 | ) | (10,089,252 | ) | (7,187,535 | ) | ||||||||
| Total Operating Expenses | (6,616,862 | ) | (5,152,019 | ) | (21,172,016 | ) | (15,563,431 | ) | ||||||||
| Loss From Operations | (6,603,755 | ) | (5,171,515 | ) | (21,136,113 | ) | (15,632,052 | ) | ||||||||
| Other Income (Expense) | 3,008 | (93,332 | ) | 25,980 | (557,615 | ) | ||||||||||
| Net Loss Before Income Taxes | (6,600,747 | ) | (5,264,847 | ) | (16,189,667 | ) | (16,189,667 | ) | ||||||||
| Tax Benefit | - | - | 5,169,395 | 5,060,778 | ||||||||||||
| Net Loss | (6,600,747 | ) | (5,264,847 | ) | (15,940,738 | ) | (11,128,889 | |||||||||
| Total other comprehensive income (loss) | (5,931 | ) | (2,339 | ) | 2,402 | 5,479 | ||||||||||
| Comprehensive Loss | $ | (6,606,678 | ) | $ | (5,267,186 | ) | $ | (15,938,336 | ) | $ | (11,123,410 | ) | ||||
| Net Loss | $ | (6,600,747 | ) | $ | (5,264,847 | ) | $ | (15,940,738 | ) | $ | (11,128,889 | ) | ||||
| Deemed dividend as a result of warrant modification | - | (369,500 | ) | - | (369,500 | ) | ||||||||||
| Deemed dividend as a result of exchange of convertible note, Series C-2, D and F preferred stock, related party | - | (26,733,098 | ) | - | (26,733,098 | ) | ||||||||||
| Net Loss Attributable to Common Shareholders | $ | (6,600,747 | ) | $ | (32,367,445 | ) | $ | (15,940,738 | ) | $ | (38,231,487 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.22 | ) | $ | (1.35 | ) | $ | (0.58 | ) | $ | (1.62 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 29,601,412 | 24,015,927 | 27,276,648 | 23,642,033 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET
| September 30, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and restricted cash | $ | 34,547,452 | $ | 16,525,187 | ||||
| Short-term investments | $ | 2,674,770 | $ | 11,984,157 | ||||
| Total Assets | $ | 40,022,550 | $ | 29,475,910 | ||||
| Total Liabilities | $ | 5,553,331 | $ | 5,829,650 | ||||
| Accumulated deficit | $ | (211,361,910 | ) | $ | (195,421,172 | ) | ||
| Total Stockholders' Equity | $ | 34,469,219 | $ | 23,646,260 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
| Nine Month Periods Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (15,940,738 | ) | $ | (11,128,889 | ) | ||
| Net cash used in operating activities | (16,034,152 | ) | (11,167,318 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities | 9,273,640 | (12,316,718 | ) | |||||
| 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 | 3,045,730 | 15,234,529 | ||||||
| Proceeds from exercise of warrants | 411,751 | 8,658,233 | ||||||
| Proceeds from exchange agreement, related party | - | 2,000,000 | ||||||
| Proceeds from exercise of stock options | - | 117,529 | ||||||
| Net cash provided by financing activities | 24,777,651 | 26,010,291 | ||||||
| Net Increase in Cash | 18,022,265 | 2,520,023 | ||||||
| Cash - Beginning of Period | 16,525,187 | 17,795,323 | ||||||
| Cash - End of Period | $ | 34,547,452 | $ | 20,315,346 |