Full Press Release Details
INC. REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 8:30 a.m. Eastern Time
NJ - November 10, 2022 - CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced financial results for
the third quarter and nine months ended September 30, 2022 and provided an update on recent business events.
Corporate Highlights:
Joe Todisco, CorMedix
CEO, commented, "the CorMedix team has made excellent progress on all fronts, working diligently in support of the CMO as it implements
corrective actions to address deficiencies the CMO received from FDA during a June inspection of the manufacturing facility, as well as
undertaking multiple steps to build out the team, processes and systems to be ready for commercialization as quickly as possible following
a potential FDA approval. We have created parallel pathways to mitigate risk, with the goal of securing FDA approval of DefenCath in 2023.
We look forward to providing additional updates as we aim to deliver on our commitment to patients receiving hemodialysis via central
Third Quarter and Nine Month 2022 Financial
For the third quarter
of 2022, CorMedix recorded a net loss of $6.9 million, or $0.17 per share, compared with a net loss of $8.6 million, or $0.22 per share,
in the third quarter of 2021. The lower net loss recognized during the third quarter of 2022 compared with 2021 was due to the net decrease
in operating expenses.
Operating expenses in
the third quarter of 2022 decreased approximately 19% to $7.0 million, compared with $8.6 million in the third quarter of 2021. R&D
expense decreased approximately 51% to $2.3 million compared to $4.7 million in the third quarter of 2021, mainly due to a net decrease
in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately
21% to $4.6 million compared with $3.8 million in the third quarter of 2021. This increase was driven primarily by an increase in costs
related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath.
For the nine months ended
September 30, 2022, CorMedix recorded a net loss of $21.5 million, or $0.54 per share, compared with a net loss of $20.4 million, or $0.54
per share, in the first nine months of 2021. The increase in net loss in the first nine months of 2022 was driven primarily by a lower
tax benefit from the NJ NOL program and an increase in operating expenses.
Operating expenses in
the first nine months of 2022 were $22.3 million compared with $21.7 million during the comparable period in 2021, an increase of $0.6
million, or 3%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by lower costs
related to the manufacturing of DefenCath prior to its potential marketing approval during the nine-month period of 2022.
Total cash on hand and
short-term investments as of September 30, 2022 was $59.0 million, excluding restricted cash of $0.2 million. The Company believes that,
based on the Company's cash resources at September 30, 2022, it has sufficient resources to fund operations at least through 2023.
Conference Call Information
The management team of
CorMedix will host a conference call and webcast today, November 10, 2022, at 8:30 AM Eastern Time, to discuss recent corporate developments
and financial results. Call details and dial-in information is as follows:
| Domestic: | 1-877-423-9813 |
| International: | 1-201-689-8573 |
| Conference ID: | 13733378 |
| 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 address the deficiencies identified by the FDA; the ability of
the Company's heparin supplier to 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 by the end of the first quarter of 2023; 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.
Inc. and SubsidiarIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 6,817 | $ | 38,088 | $ | 35,706 | $ | 134,539 | ||||||||
| Cost of sales | (1,469 | ) | (25,166 | ) | (3,328 | ) | (100,931 | ) | ||||||||
| Gross profit | 5,348 | 12,922 | 32,378 | 33,608 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (2,339,268 | ) | (4,741,228 | ) | (7,836,327 | ) | (9,897,763 | ) | ||||||||
| Selling, general and administrative | (4,628,014 | ) | (3,836,613 | ) | (14,430,791 | ) | (11,793,509 | ) | ||||||||
| Total Operating Expenses | (6,967,282 | ) | (8,577,841 | ) | (22,267,118 | ) | (21,691,272 | ) | ||||||||
| Loss From Operations | (6,961,934 | ) | (8,564,919 | ) | (22,234,740 | ) | (21,657,664 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Total Other Income (Expense) | 108,213 | (4,447 | ) | 156,369 | (11,761 | ) | ||||||||||
| Loss before income taxes | (6,853,721 | ) | (8,569,366 | ) | (22,078,371 | ) | (21,669,425 | ) | ||||||||
| Tax benefit | - | - | 585,617 | 1,250,186 | ||||||||||||
| Net Loss | (6,853,721 | ) | (8,569,366 | ) | (21,492,754 | ) | (20,419,239 | ) | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Total Other Comprehensive Income (Loss) | 6,253 | (3,679 | ) | (41,358 | ) | (6,504 | ) | |||||||||
| Comprehensive Loss | $ | (6,847,468 | ) | $ | (8,573,045 | ) | $ | (21,534,112 | ) | $ | (20,425,743 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.17 | ) | $ | (0.22 | ) | $ | (0.54 | ) | $ | (0.54 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 41,183,585 | 38,113,514 | 39,741,555 | 37,515,298 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 43,470,079 | $ | 53,551,277 | ||||
| Short-term investments | $ | 15,746,224 | $ | 12,149,003 | ||||
| Total Assets | $ | 62,076,932 | $ | 68,945,576 | ||||
| Total Liabilities | $ | 5,764,846 | $ | 6,147,509 | ||||
| Accumulated deficit | $ | (267,151,835 | ) | $ | (245,659,081 | ) | ||
| Total Stockholders' Equity | $ | 56,312,086 | $ | 62,798,067 |
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Nine Month Periods Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (21,492,754 | ) | $ | (20,419,239 | ) | ||
| Net cash used in operating activities | (18,201,893 | ) | (15,285,863 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash used in investing activities | (3,707,503 | ) | (2,005,711 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Net cash provided by financing activities | 11,852,662 | 41,757,551 | ||||||
| Net (Decrease) Increase in Cash and Cash Equivalents | (10,081,198 | ) | 24,456,178 | |||||
| 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 | $ | 43,470,079 | $ | 66,552,961 |