Part I Financial Information [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) CorMedix reported an increased net loss in Q1 2024, driven by higher SG&A for DefenCath's launch, with total assets decreasing to **$68.0 million** Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $35,180,529 | $43,642,684 | | Short-term investments | $23,370,989 | $32,388,130 | | Inventories | $2,320,396 | $2,106,345 | | License intangible asset | $2,000,000 | $0 | | **Total Assets** | **$68,023,742** | **$82,059,957** | | **Liabilities & Equity** | | | | Total Liabilities | $10,011,022 | $11,917,528 | | Total Stockholders' Equity | $58,012,720 | $70,142,429 | | **Total Liabilities and Stockholders' Equity** | **$68,023,742** | **$82,059,957** | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Revenues, net | $0 | $0 | | Gross loss | ($819) | $0 | | Research and development | ($837) | ($3,407) | | Selling, general and administrative | ($15,048) | ($7,610) | | Loss From Operations | ($16,704) | ($11,017) | | Net Loss | **($14,466)** | **($10,567)** | | Net Loss Per Common Share | **($0.25)** | **($0.24)** | Condensed Consolidated Statements of Cash Flows (Unaudited) | Activity | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,310) | ($10,394) | | Net cash provided by (used in) investing activities | $8,945 | ($14,687) | | Net cash (used in) provided by financing activities | ($97) | $7,200 | | **Net Decrease in Cash and Cash Equivalents** | **($8,463)** | **($17,878)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) CorMedix focuses on DefenCath's U.S. commercialization, with Q1 2024 net loss increasing due to higher SG&A, partially offset by decreased R&D [Overview](index=24&type=section&id=Overview) CorMedix is commercializing DefenCath, an FDA-approved antimicrobial catheter lock solution with marketing exclusivity, launched for inpatient use in April 2024 - The FDA approved DefenCath on **November 15, 2023**, as the first and only FDA-approved antimicrobial CLS in the U.S. to reduce CRBSI in adult hemodialysis patients[96](index=96&type=chunk) - DefenCath received **10 years of marketing exclusivity** (5 years NCE, 5 years GAIN Act) until **November 15, 2033**[97](index=97&type=chunk) - CMS approved a Transitional Drug Add-On Payment (TDAPA) for DefenCath, effective **July 1, 2024**, providing **five years** of additional outpatient reimbursement[108](index=108&type=chunk)[99](index=99&type=chunk) - The U.S. commercial launch for inpatient use of DefenCath began on **April 15, 2024**, with the first commercial supply contract signed with ARC Dialysis, LLC[107](index=107&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) CorMedix's Q1 2024 net loss increased to **$14.5 million** due to a **97%** rise in SG&A for DefenCath's launch, partially offset by a **75%** decrease in R&D expenses Comparison of Operating Results (in thousands) | Account | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Gross loss | ($819) | $0 | N/A | | Research and development | ($838) | ($3,407) | (75)% | | Selling, general and administrative | ($15,048) | ($7,610) | 98% | | **Loss from operations** | **($16,705)** | **($11,017)** | **52%** | | **Net loss** | **($14,467)** | **($10,568)** | **37%** | - SG&A expenses increased by **$7.4 million (97%)** year-over-year, driven by **$3.8 million** in personnel costs and **$2.7 million** for market research and launch activities[122](index=122&type=chunk) - R&D expenses decreased by **$2.6 million (75%)** year-over-year, primarily due to reclassification of costs to SG&A and capitalization of manufacturing expenses post-FDA approval[121](index=121&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, CorMedix held **$58.6 million** in cash and investments, sufficient for at least twelve months of operations, despite increased cash usage for Q1 2024 operating activities - The company's **$58.6 million** in cash, cash equivalents, and short-term investments as of **March 31, 2024**, are estimated to fund operations for at least **twelve months**[132](index=132&type=chunk)[136](index=136&type=chunk) - Net cash used in operating activities increased to **$17.3 million** in Q1 2024 from **$10.4 million** in Q1 2023, driven by a higher net loss and increased working capital for the commercial launch[129](index=129&type=chunk) - In **March 2024**, the company received **$1.4 million** from the sale of its New Jersey net operating losses (NOLs)[128](index=128&type=chunk) - The company expects to implement an ATM program and may seek additional capital through equity or debt financing to support ongoing funding requirements[134](index=134&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a Smaller Reporting Company, CorMedix is not required to provide quantitative and qualitative disclosures about market risk - As a Smaller Reporting Company, CorMedix is not required to provide information regarding quantitative and qualitative disclosures about market risk[141](index=141&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **March 31, 2024**[142](index=142&type=chunk) - No material changes occurred during the quarter affecting the company's internal control over financial reporting[143](index=143&type=chunk) Part II Other Information [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending against a consolidated securities class action and a shareholder derivative lawsuit, both related to DefenCath NDA statements and fiduciary duties - The company is defending a securities class action lawsuit (In re CorMedix Inc. Securities Litigation) alleging violations related to DefenCath NDA statements, with a third amended complaint filed in **April 2024**[54](index=54&type=chunk)[145](index=145&type=chunk) - A consolidated shareholder derivative action (In re CorMedix Inc. Derivative Litigation) alleging breaches of fiduciary duty is stayed pending the class action lawsuit's motion to dismiss[55](index=55&type=chunk)[58](index=58&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - No material changes occurred from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended **December 31, 2023**[146](index=146&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - None[147](index=147&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) The report includes standard filings such as CEO and CFO certifications under Sarbanes-Oxley Act and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act, along with Inline XBRL documents[153](index=153&type=chunk)

Financial Performance - For Q1 2024, the company recorded a net loss of $14.5 million, or $0.25 per share, compared to a net loss of $10.6 million, or $0.24 per share, in Q1 2023, representing an increase of approximately 37%[27] - Operating expenses for Q1 2024 were $15.9 million, a 44% increase from $11.0 million in Q1 2023, primarily driven by a 98% increase in selling, general, and administrative expenses[28] - The accumulated deficit increased to $(336.2) million as of March 31, 2024, compared to $(321.7) million at the end of 2023[14] - The company received $1.4 million from the sale of New Jersey NOLs, partially offsetting the increase in net loss[27] Cash and Liabilities - As of March 31, 2024, the company reported cash and short-term investments of $58.6 million, excluding restricted cash[3] - Total liabilities as of March 31, 2024, were $10.0 million, down from $11.9 million as of December 31, 2023[14] Product Development and Launch - The company entered into a 5-year commercial supply contract with ARC Dialysis, LLC for the supply of DefenCath[9] - The FDA granted the company's Type C meeting request to discuss an updated development plan for DefenCath in Total Parenteral Nutrition and pediatric study requirements, with feedback expected by the end of Q2 2024[17] - The company launched DefenCath in inpatient settings on April 15, 2024, and plans to launch in outpatient settings in July 2024[18] - The company anticipates approval of a supplement to the NDA adding Siegfried Hameln as an alternate manufacturing site for DefenCath by the end of 2024[26]

BERKELEY HEIGHTS, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it will report its financial results for the first quarter ended March 31, 2024, before the market opens on Thursday, May 9, 2024, and will host a corporate update conference call at 8:30am Eastern Time. Thursday, May 9th @ 8:30am ETDomestic:1-888-886-7786Internationa ...

CorMedix (CRMD) closed the last trading session at $5.52, gaining 33.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $13 indicates a 135.5% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $4.55. While the lowest estimate of $9 indicates a 63% increase from the current price level, the most optimistic analyst expects the sto ...

BERKELEY HEIGHTS, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced DefenCath® (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for U.S. inpatient use. DefenCath (taurolidine and heparin) is approved by the U.S. Food and Drug Administration (FDA) to reduce the incidence of catheter-related bloodstream ...

Shares of CorMedix (CRMD) have gained 35.4% over the past four weeks to close the last trading session at $5.28, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $13 indicates a potential upside of 146.2%.The mean estimate comprises four short-term price targets with a standard deviation of $4.55. While the lowest estimate of $9 indicates a 70.5% increase from the current price l ...

BERKELEY HEIGHTS, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a 5-year commercial supply contract with Florida-based dialysis provider, ARC Dialysis, LLC for the supply of DefenCath® (taurolidine and heparin). CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Dru ...

Financial Data and Key Metrics Changes - The net loss for the fourth quarter of 2023 was approximately $14.8 million, or $0.26 per share, compared to a loss of $8.2 million, or $0.20 per share, in the fourth quarter of 2022, primarily driven by increased costs related to market research and pre-launch activities for DefenCath [75] - Total operating expenses for the full year 2023 amounted to $49 million, an increase of 60% compared to $30.7 million in 2022 [55] - Cash and cash equivalents were reported at $76 million as of December 31, 2023, with expectations for operating expenses to increase in 2024 due to the commercial launch of DefenCath [11][56] Business Line Data and Key Metrics Changes - Research and Development (R&D) expenses decreased by approximately 19% to $2.3 million in Q4 2023, primarily due to reduced manufacturing costs related to DefenCath [10] - Selling, General and Administrative (SG&A) expenses increased approximately 140% to $13.4 million in Q4 2023, driven by launch activities and higher personnel costs [10] Market Data and Key Metrics Changes - The company anticipates a modest ramp in in-patient utilization over the first two launch quarters as hospitals work through their Pharmacy and Therapeutics (P&T) formulary review processes, which can take three to nine months [7][28] - Significant interest has been received from large and midsized health systems, with expectations for intensified activity in the coming months as key account managers begin pre-launch contracting discussions [7] Company Strategy and Development Direction - The company is focused on the commercial launch of DefenCath in April 2024, with a strategy to engage in customer discussions across both in-patient and outpatient settings [57] - Plans include submitting a post-approval meeting request to the FDA by the end of March 2024 to discuss potential clinical pathways for label expansion [57] - The company aims to achieve breakeven profitability on a run rate basis by the end of December 2024, contingent on meeting internal assumptions for demand and reimbursement [53] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch potential for 2024 and beyond, highlighting the importance of securing reimbursement and demonstrating the product's value to healthcare providers [57][45] - The company is preparing for potential shifts in political tides affecting CMS reimbursement policies, although current expectations remain stable [21] Other Important Information - The company has filed its annual report on Form 10-K for the year ended December 31, 2023, urging stakeholders to review the detailed financial results [54] - The company has built a field sales and medical affairs team with experience in infectious disease and nephrology, preparing for the anticipated commercial launch [52] Q&A Session Summary Question: Can you provide more detail on the progress with hospital P&T committees? - Management confirmed that meetings are scheduled and emphasized the importance of physician champions advocating for the product during the formulary adoption process [106] Question: What are the distribution channels and inventory levels ahead of launch? - The distribution will flow through specialty distributors for in-patient facilities, with a mix of direct shipping for outpatient customers [102] Question: What impact will the lower WAC price have on NTAP reimbursement and in-patient utilization? - Management indicated that the lower acquisition cost is expected to drive higher utilization on the in-patient side, with no immediate adjustments to the WAC price anticipated during the TDAPA period [87][41]

BERKELEY HEIGHTS, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business. Recent Corporate Highlights: On November 15, 2023, CorMedix received FDA approval for its new drug application (NDA) for ...

PART I [Business](index=9&type=section&id=Item%201.%20Business) CorMedix focuses on commercializing DefenCath, its FDA-approved antimicrobial catheter lock solution, for hemodialysis patients, with market exclusivity until 2033 and established reimbursement pathways - The company's primary focus is the U.S. commercialization of its lead product, DefenCath, an antimicrobial catheter lock solution (CLS)[26](index=26&type=chunk) - On November 15, 2023, the FDA approved the New Drug Application (NDA) for DefenCath to reduce catheter-related bloodstream infections (CRBSI) in adult kidney failure patients on hemodialysis via a central venous catheter (CVC)[28](index=28&type=chunk) - DefenCath has been granted New Chemical Entity (NCE) exclusivity until November 2028 and an additional 5-year GAIN exclusivity, extending its market protection to **November 2033**[29](index=29&type=chunk) - The company has secured a New Technology Add-On Payment (NTAP) for inpatient hospital use of DefenCath and has applied for a Transitional Drug Add-on Payment Adjustment (TDAPA) for outpatient dialysis settings, with a target implementation date of July 1, 2024[32](index=32&type=chunk)[33](index=33&type=chunk) - CorMedix relies on third-party contract manufacturing organizations (CMOs) for production and is in the process of qualifying alternative manufacturing sites and suppliers for its key active pharmaceutical ingredients (APIs)[54](index=54&type=chunk)[55](index=55&type=chunk)[57](index=57&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including operating losses, high dependence on DefenCath's commercialization, reimbursement uncertainties, market concentration, and reliance on third-party manufacturers - The company has a history of operating losses, incurring a net loss of **$46.3 million in 2023** and an accumulated deficit of **$321.7 million** as of December 31, 2023; future profitability is uncertain[118](index=118&type=chunk) - CorMedix is highly dependent on the successful commercialization of its only approved product, DefenCath; failure to successfully launch and market the product would severely limit revenue generation[123](index=123&type=chunk) - Successful commercialization hinges on obtaining adequate coverage and reimbursement from third-party payors like Medicare and private insurers; a pending TDAPA application for outpatient use is critical, and any delay or denial would adversely impact the launch[126](index=126&type=chunk)[128](index=128&type=chunk) - The outpatient dialysis market is highly concentrated, with two large providers accounting for over **70% of treatments**; failure to secure utilization from these key customers could significantly harm the commercial launch[129](index=129&type=chunk) - The company relies on single FDA-approved suppliers for its key APIs (taurolidine and heparin) and a single approved manufacturing site for the finished product, creating risks of supply chain disruption[187](index=187&type=chunk)[188](index=188&type=chunk) [Cybersecurity](index=50&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity threats through its Audit Committee, implementing annual employee training, threat simulations, and cyber liability insurance, with no material incidents reported - The Board's Audit Committee has primary oversight responsibility for cybersecurity risk management[227](index=227&type=chunk) - The company's cybersecurity strategy includes annual mandatory employee training, regular simulation modules, and carrying cyber liability insurance[225](index=225&type=chunk) - No cybersecurity threats or incidents have materially affected the company during the period covered by this report[226](index=226&type=chunk) [Properties](index=51&type=section&id=Item%202.%20Properties) CorMedix's principal executive office is in Berkeley Heights, New Jersey, under a seven-year lease, supplemented by a small leased office in Germany, both deemed adequate for current needs - The company's main office is in Berkeley Heights, NJ, under a seven-year lease that began in September 2020 with an average monthly cost of approximately **$17,000**[230](index=230&type=chunk) [Legal Proceedings](index=51&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business operations - Management does not believe any current legal proceedings will have a material adverse effect on the business[232](index=232&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=52&type=section&id=Item%205.%20Market%20for%20the%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) CorMedix's common stock trades on Nasdaq under "CRMD," and the company has never paid dividends, intending to retain earnings for business growth - The company's common stock is listed on the Nasdaq Global Market under the symbol **"CRMD"**[236](index=236&type=chunk) - The company has never paid dividends and does not intend to in the foreseeable future, retaining earnings for business growth[237](index=237&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2023, CorMedix reported a net loss of $46.3 million, driven by increased SG&A and R&D expenses, ending the year with $76.0 million in cash, sufficient to fund operations for at least twelve months and support DefenCath's launch Selected Financial Data | | 2023 ($) | 2022 ($) | % Change | | :--- | :--- | :--- | :--- | | **Revenue** | 0 | 65,000 | (100)% | | **Research and development** | (13,155,000) | (10,680,000) | 23% | | **Selling, general and administrative** | (35,803,000) | (20,006,000) | 79% | | **Loss from operations** | (48,958,000) | (30,625,000) | 60% | | **Net loss** | (46,339,000) | (29,702,000) | 56% | - The increase in R&D expense was primarily due to higher personnel costs from increased headcount, increased medical affairs activities, and costs related to manufacturing operations for DefenCath prior to its approval[264](index=264&type=chunk) - The significant increase in SG&A expense was mainly driven by **$12.2 million** in costs for market research and pre-launch activities for DefenCath, along with a **$3.7 million** increase in personnel expenses from new hires in preparation for the launch[265](index=265&type=chunk) - Net cash used in operating activities increased to **$38.4 million in 2023** from **$24.4 million in 2022**, driven by the higher net loss and increased operating expenses for DefenCath's pre-launch activities[272](index=272&type=chunk) - The company raised net proceeds of **$42.9 million** from a public offering and **$12.9 million** from its ATM program in 2023; as of December 31, 2023, cash, cash equivalents, and short-term investments totaled **$76.0 million**[271](index=271&type=chunk)[275](index=275&type=chunk) - Management estimates that current cash is sufficient to fund operations for at least twelve months and support the commercial launch of DefenCath through to anticipated profitability, assuming a launch in Q2 2024[279](index=279&type=chunk) [Controls and Procedures](index=59&type=section&id=Item%209A.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes reported - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period[286](index=286&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, based on the COSO framework[293](index=293&type=chunk) PART III [Directors, Executive Officers, and Corporate Governance](index=61&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) The report details the company's directors and executive officers, noting that most directors are independent and the Board maintains key committees with independent members - The Board of Directors consists of seven members, with Myron Kaplan serving as Chairman of the Board[299](index=299&type=chunk)[303](index=303&type=chunk) - The Board has determined that all directors are independent under Nasdaq rules, with the exception of CEO Joseph Todisco[309](index=309&type=chunk) - The Board has established Audit, Compensation, and Nominating and Governance committees, all composed of independent directors[310](index=310&type=chunk) [Executive Compensation](index=67&type=section&id=Item%2011.%20Executive%20Compensation) Non-employee directors receive cash and stock options, while CEO Joseph Todisco's 2023 total compensation was approximately $2.46 million, with executive agreements including severance provisions Executive Compensation Summary | Name and Principal Position | Year | Salary ($) | Option Awards ($) | Non-equity Incentive Plan Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Joseph Todisco**, CEO | 2023 | 616,962 | 1,388,400 | 401,700 | 2,459,342 | | **Matthew David**, CFO | 2023 | 389,135 | 433,875 | 156,000 | 1,031,150 | | **Erin Mistry**, CCO | 2023 | 389,577 | 694,200 | 156,800 | 1,240,577 | | **Phoebe Mounts**, Former General Counsel | 2023 | 375,000 | 433,875 | 112,500 | 1,254,582 | - Non-employee directors receive an annual cash fee of **$55,000**, additional fees for chair and committee roles, and an annual grant of **20,000 stock options** (increased to **30,000** in March 2024)[330](index=330&type=chunk)[331](index=331&type=chunk) - CEO Joseph Todisco's employment agreement provides for an annual salary of **$618,000** and a target bonus of **65% of base salary**[336](index=336&type=chunk) - Executive employment agreements contain severance provisions, including salary continuation (**12 months for the CEO**) and accelerated equity vesting upon termination without cause or for good reason, with enhanced benefits following a corporate transaction[342](index=342&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=74&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 7, 2024, directors and executive officers collectively owned 4.8% of common stock, with Blackrock and Nomura as major institutional shareholders, and the company maintains an equity compensation plan - As of March 7, 2024, **Blackrock, Inc.** was the largest beneficial owner with **6.4%** of common stock, followed by **Nomura Global Financial Products, Inc.** with **5.4%**[359](index=359&type=chunk) - All current executive officers and directors as a group beneficially owned approximately **2.73 million shares**, representing **4.8%** of the outstanding common stock[359](index=359&type=chunk) Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise (a) | Weighted average exercise price (b) | Securities remaining available for future issuance (c) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 6,365,243 | $5.44 | 3,108,929 | [Principal Accounting Fees and Services](index=77&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) For 2023, CorMedix paid Marcum LLP $225,225 in audit fees, an increase from 2022, with all services pre-approved by the Audit Committee Audit Fees | Fee Type | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Audit Fees (Marcum LLP) | 225,225 | 127,000 | | Audit Fees (Friedman LLP) | 0 | 42,400 | | **Total** | **225,225** | **169,400** | - All audit and permissible non-audit services provided by the independent registered public accounting firm were pre-approved by the Audit Committee[367](index=367&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=78&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index of consolidated financial statements and all exhibits filed with the Form 10-K, including various corporate and contractual documents - This section contains the index of financial statements and a list of all exhibits filed with the Form 10-K[370](index=370&type=chunk)[371](index=371&type=chunk) Financial Statements [Consolidated Financial Statements](index=84&type=section&id=Consolidated%20Financial%20Statements) The 2023 consolidated financial statements show a net loss of $46.3 million, increased assets and liabilities, and higher stockholders' equity, reflecting financing activities Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $76,031 | $58,792 | | Total Assets | $82,060 | $62,038 | | Total Liabilities | $11,918 | $6,979 | | Total Stockholders' Equity | $70,142 | $55,060 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $65 | | Loss From Operations | $(48,958) | $(30,624) | | Net Loss | $(46,339) | $(29,702) | | Net Loss Per Share | $(0.91) | $(0.74) | [Notes to Consolidated Financial Statements](index=88&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, liquidity, ongoing securities litigation, 2023 financing proceeds, and the full valuation allowance against deferred tax assets - The company's existing cash, cash equivalents, and short-term investments are expected to fund operations for at least twelve months from the report's issuance date[415](index=415&type=chunk) - The company is a defendant in a consolidated securities class action lawsuit and shareholder derivative lawsuits alleging false and misleading statements related to the DefenCath NDA submission process; the company intends to vigorously contest these claims[466](index=466&type=chunk)[467](index=467&type=chunk) - In 2023, the company raised approximately **$42.9 million (net)** from a public offering of common stock and pre-funded warrants, and **$12.9 million (net)** from its ATM program[478](index=478&type=chunk)[481](index=481&type=chunk) - The company maintains a full valuation allowance of **$70.8 million** against its net deferred tax assets as of December 31, 2023, as it is more likely than not that these assets will not be realized[456](index=456&type=chunk)[462](index=462&type=chunk) - Upon FDA approval of DefenCath, costs related to manufacturing inventory are capitalized; inventory previously expensed as R&D prior to approval amounted to **$6.4 million**[432](index=432&type=chunk)