CorMedix Inc. Reports Third Quarter 2021 Financial Results and Provides Business Update
CorMedix Inc. (Nasdaq: CRMD) reported its third quarter 2021 financial results, announcing a net loss of $8.6 million or $0.22 per share, compared to a loss of $6.6 million in Q3 2020. The increase in losses was attributed to a 30% rise in operating expenses, primarily due to heightened manufacturing costs for DefenCath. Despite challenges, manufacturing activities have resumed, and the company aims to resubmit its NDA. With $72 million in cash, CorMedix believes it can fund operations through 2022. A conference call is scheduled for November 9, 2021 to further discuss developments.
- Manufacturing activities for DefenCath have resumed.
- CorMedix has $72 million in cash and short-term investments, ensuring operations through 2022.
- Net loss increased to $8.6 million in Q3 2021 from $6.6 million in Q3 2020.
- Operating expenses rose 30% to $8.6 million primarily due to manufacturing costs.
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time
BERKELEY HEIGHTS, N.J., Nov. 09, 2021 (GLOBE NEWSWIRE) -- 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.
Recent Corporate and Regulatory Highlights:
- As noted previously, there was a delay as a result of issues at the third-party manufacturer, or CMO, unrelated to the manufacture of DefenCath. Together with our CMO, we have been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified at the manufacturing facility.
- CorMedix continues to work diligently toward the resubmission of the DefenCath NDA and plans to provide an update when we have clarity on the submission timeline.
- CorMedix announced in October that its Board had appointed Matt David M.D., CorMedix’s EVP and Chief Financial Officer, as interim Chief Executive Officer. In addition, CorMedix expanded the responsibilities of Phoebe Mounts, Ph.D., Esq., EVP, General Counsel, and Head of Regulatory, Compliance, and Legal to include leadership of the Technical Operations group.
- CorMedix presented three abstracts at industry conferences including the Association of Managed Care Pharmacy (AMCP) Nexus conference in October and the American Society of Nephrology (ASN) conference in November. The presentations highlighted retrospective analyses that were conducted to better understand the incidence of and mortality related to CRBSIs and economic costs related to these infections.
- Cash and short-term investments, excluding restricted cash, at September 30, 2021 amounted to
$72.0 million .
Dr. 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.”
Third Quarter and Nine Month 2021 Financial Highlights
For the third quarter of 2021, CorMedix recorded a net loss of
Operating expenses in the third quarter of 2021 increased approximately
For the nine months ended September 30, 2021, CorMedix recorded a net loss of
Operating expenses in the first nine months of 2021 were
Total cash on hand and short-term investments as of September 30, 2021 was
Conference Call Information
The 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 |
About CorMedix
CorMedix 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.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
| 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 | ||||||||
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
| 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 | ||
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW DATA
(Unaudited)
| 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 | |||
FAQ
What were CorMedix's financial results for Q3 2021?
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How much cash does CorMedix have as of September 30, 2021?
What factors contributed to CorMedix's increased losses in Q3 2021?
When will CorMedix discuss its financial results and corporate developments?
