CorMedix Inc. Files Q3 2024 10-Q Report

TL;DR

CorMedix filed its 10-Q for Q3 2024. Check financials.

AI Summary

CorMedix Inc. filed its quarterly report on Form 10-Q for the period ended September 30, 2024. The company, incorporated in Delaware, is involved in the pharmaceutical preparations industry. Its principal executive offices are located at 300 Connell Drive, Suite 4200, Berkeley Heights, NJ 07922. The filing details its financial performance and business operations for the specified quarter.

Why It Matters

This filing provides investors and stakeholders with an update on CorMedix Inc.'s financial health and operational progress during the third quarter of 2024.

Risk Assessment

Risk Level: low — This is a standard quarterly financial filing and does not inherently present new risks.

Key Players & Entities

• CorMedix Inc. (company) — Registrant
• September 30, 2024 (date) — Quarterly period end date
• 300 Connell Drive, Suite 4200, Berkeley Heights, NJ 07922 (address) — Principal Executive Offices
• 001-34673 (company) — Commission file number

FAQ

Key Financial Figures

• $0.001 — ange on which registered Common stock, $0.001 par value CRMD Nasdaq Global Market I

Filing Documents

• ea0218371-10q_cormedix.htm (10-Q) — 772KB
• ea021837101ex31-1_cormedix.htm (EX-31.1) — 10KB
• ea021837101ex31-2_cormedix.htm (EX-31.2) — 10KB
• ea021837101ex32-1_cormedix.htm (EX-32.1) — 4KB
• ea021837101ex32-2_cormedix.htm (EX-32.2) — 4KB
• 0001213900-24-091961.txt ( ) — 4522KB
• crmd-20240930.xsd (EX-101.SCH) — 32KB
• crmd-20240930_cal.xml (EX-101.CAL) — 41KB
• crmd-20240930_def.xml (EX-101.DEF) — 194KB
• crmd-20240930_lab.xml (EX-101.LAB) — 361KB
• crmd-20240930_pre.xml (EX-101.PRE) — 201KB
• ea0218371-10q_cormedix_htm.xml (XML) — 527KB

FINANCIAL INFORMATION

PART I FINANCIAL INFORMATION 1 Item 1. Unaudited Condensed Consolidated Financial Statements 1 Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 1 Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023 2 Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2024 and 2023 3 Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 5 Notes to Unaudited Condensed Consolidated Financial Statements 6 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 19 Item 3. Quantitative and Qualitative Disclosure About Market Risk 30 Item 4.

Controls and Procedures

Controls and Procedures 30

OTHER INFORMATION

PART II OTHER INFORMATION 31 Item 1.

Legal Proceedings

Legal Proceedings 31 Item 1A.

Risk Factors

Risk Factors 31 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31 Item 3. Defaults Upon Senior Securities 31 Item 4. Mine Safety Disclosure 31 Item 5. Other Information 31 Item 6. Exhibits 31

SIGNATURES

SIGNATURES 32 i PART I FINANCIAL INFORMATION

Unaudited Condensed Consolidated Financial Statements

Item 1. Unaudited Condensed Consolidated Financial Statements. CorMedix Inc. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS September 30, 2024 (Unaudited) December 31, 2023 ASSETS Current assets Cash and cash equivalents $ 35,286,138 $ 43,642,684 Restricted cash - 77,453 Short-term investments 10,743,562 32,388,130 Trade receivables, net 17,387,446 - Inventories, net 6,649,495 2,106,345 Prepaid research and development expenses 170,739 353,574 Other prepaid expenses and current assets 2,916,889 882,214 Total current assets 73,154,269 79,450,400 Property and equipment, net 1,899,875 1,866,224 License intangible asset, net 1,896,104 - Restricted cash, long-term 105,084 103,055 Operating lease right-of-use asset 530,862 640,278 TOTAL ASSETS $ 77,586,194 $ 82,059,957 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 1,343,833 $ 4,279,679 Accrued expenses 16,973,677 6,970,217 Operating lease liability, short-term 163,449 150,619 Total current liabilities 18,480,959 11,400,515 Operating lease liability, net of current portion 392,967 517,013 TOTAL LIABILITIES 18,873,926 11,917,528 COMMITMENTS AND CONTINGENCIES (Note 5) STOCKHOLDERS' EQUITY Preferred stock - $ 0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at September 30, 2024 and December 31, 2023 182 182 Common stock - $ 0.001 par value: 160,000,000 shares authorized; 57,887,149 and 54,938,258 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 57,886 54,938 Accumulated other comprehensive gain 89,120 94,108 Additional paid-in capital 411,659,517 391,693,214 Accumulated deficit ( 353,094,437 ) ( 321,700,013 ) TOTAL STOCKHOLDERS' EQUITY 58,712,268 70,142,429 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 77,586,194 $ 82,059,957 See Accompanying Notes to Unaudited Condensed Consolidated

Financial Statements

Financial Statements. 1 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, 2024 2023 2024 2023 Revenue: Net sales $ 11,456,115 $ - $ 12,262,234 $ - Cost of sales ( 686,598 ) - ( 2,014,975 ) - Gross profit 10,769,517 - 10,247,259 - Operating Expenses: Research and development ( 727,119 ) ( 2,663,976 ) ( 2,215,551 ) ( 10,866,236 ) Selling and marketing ( 6,748,900 ) ( 4,058,428 ) ( 20,472,961 ) ( 9,955,651 ) General and administrative ( 6,580,834 ) ( 3,744,879 ) ( 22,851,144 ) ( 12,467,157 ) Total Operating Expenses ( 14,056,853 ) ( 10,467,283 ) ( 45,539,656 ) ( 33,289,044 ) Loss From Operations ( 3,287,336 ) ( 10,467,283 ) ( 35,292,397 ) ( 33,289,044 ) Other Income (Expense): Interest income 553,856 765,241 2,068,407 1,761,808 Foreign exchange transaction loss ( 33,325 ) ( 29,199 ) ( 38,806 ) ( 30,222 ) Other income - - 500,000 - Interest expense ( 10,007 ) ( 13,113 ) ( 26,398 ) ( 27,740 ) Total Other Income 510,524 722,929 2,503,203 1,703,846 Loss before income taxes ( 2,776,812 ) ( 9,744,354 ) ( 32,789,194 ) ( 31,585,198 ) Tax benefit - - 1,394,770 - Net Loss ( 2,776,812 ) ( 9,744,354 ) ( 31,394,424 ) ( 31,585,198 ) Other Comprehensive Income (Loss): Unrealized gain (loss) from investments 5,040 ( 4,571 ) ( 3,832 ) 1,090 Foreign currency translation (loss) gain ( 1,651 ) ( 1,727 ) ( 1,156 ) 566 Total Other Comprehensive Income (Loss) 3,389 ( 6,298 ) ( 4,988 ) 1,656 Comprehensive Loss $ ( 2,773,423 ) $ ( 9,750,652 ) $ ( 31,399,412 ) $ ( 31,583,542 ) Net Loss Per Common Share – Basic and Diluted $ ( 0.05 ) $ ( 0.17 ) $ ( 0.54 ) $ ( 0.65 ) Weighted Average Common Shares Outstanding – Basic and Diluted 58,825,221 56,553,174 57,986,190 48,715,585 See Accompanying Notes to Unaud

Financial Statements

Financial Statements. 2 CorMedix Inc. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) For the three months ended September 30, 2024 Common Stock Preferred Stock- Series C-3, Series E and Series G Accumulated Other Comprehensive Additional Paid-in Accumulated Total Stockholders' Shares Amount Shares Amount Income Capital Deficit Equity Balance at July 1, 2024 55,274,791 $ 55,274 181,622 $ 182 $ 85,731 $ 396,360,369 $ ( 350,317,625 ) $ 46,183,931 Stock issued in connection with ATM sale of common stock, net 2,290,024 2,290 - - - 12,364,191 - 12,366,481 Stock issued in connection with options exercised 322,334 322 - - - 1,707,481 - 1,707,803 Stock-based compensation - - - - - 1,227,476 - 1,227,476 Other comprehensive gain - - - - 3,389 - - 3,389 Net loss - - - - - - ( 2,776,812 ) ( 2,776,812 ) Balance at September 30, 2024 57,887,149 $ 57,886 181,622 $ 182 $ 89,120 $ 411,659,517 $ ( 353,094,437 ) $ 58,712,268 For the nine months ended September 30, 2024 Common Stock Preferred Stock- Series C-3, Series E and Series G Accumulated Other Comprehensive Additional Paid-in Accumulated Total Stockholders' Shares Amount Shares Amount Income Capital Deficit Equity Balance at January 1, 2024 54,938,258 $ 54,938 181,622 $ 182 $ 94,108 $ 391,693,214 $ ( 321,700,013 ) $ 70,142,429 Stock issued in connection with ATM sale of common stock, net 2,521,121 2,521 - - - 13,373,560 - 13,376,081 Stock issued in connection with options exercised 371,499 371 - - - 1,893,914 - 1,894,285 Issuance of vested restricted stock, net of shares withheld for employee withholding taxes 78,103 78 ( 236,693 ) ( 236,615 ) Cancellation of shares held in escrow ( 21,832 ) ( 22 ) 22 - Stock-based compensation - - - - - 4,935,500 - 4,935,500 Other comprehensive loss - - - - ( 4,988 ) - -

Financial Statements

Financial Statements. 3 CorMedix Inc. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) For the three months ended September 30, 2023 Common Stock Preferred Stock – Series C-3, Series E and Series G Accumulated Other Comprehensive Additional Paid-in Accumulated Total Stockholders' Shares Amount Shares Amount Income (Loss) Capital Deficit Equity Balance at July 1, 2023 45,805,283 $ 45,806 181,622 $ 182 $ 90,697 $ 346,116,054 $ ( 297,201,630 ) $ 49,051,109 Stock and pre-funded warrants issued in connection with public offering, net 9,000,093 9,000 - - - 42,869,399 - 42,878,399 Stock issued in connection with options exercised 6,666 7 - - - 20,125 - 20,132 Stock-based compensation - - - - - 1,002,834 - 1,002,834 Other comprehensive loss - - - - ( 6,298 ) - - ( 6,298 ) Net loss - - - - - - ( 9,744,354 ) ( 9,744,354 ) Balance at September 30, 2023 54,812,042 $ 54,813 181,622 $ 182 $ 84,399 $ 390,008,412 $ ( 306,945,984 ) $ 83,201,822 For the nine months ended September 30, 2023 Common Stock Preferred Stock – Series C-3, Series E and Series G Accumulated Other Comprehensive Additional Paid-in Accumulated Total Stockholders' Shares Amount Shares Amount Income (Loss) Capital Deficit Equity Balance at January 1, 2023 42,815,196 $ 42,815 181,622 $ 182 $ 82,743 $ 330,294,782 $ ( 275,360,786 ) $ 55,059,736 Stock issued in connection with ATM sale of common stock, net 2,866,421 2,867 - - - 12,512,342 - 12,515,209 Stock and pre-funded warrants issued in connection with public offering, net 9,000,093 9,000 - - - 42,869,399 - 42,878,399 Stock issued in connection with options exercised 64,041 64 - - - 253,924 - 253,988 Issuance of vested restricted stock, net of shares withheld for employee withholding taxes 66,291 67 - - - ( 198,509 ) - ( 198,442 ) Stock-based compens

Financial Statements

Financial Statements. 4 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) For the Nine Months Ended September 30, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 31,394,424 ) $ ( 31,585,198 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 4,935,500 4,276,474 Change in right-of-use assets 109,416 99,970 Depreciation 72,210 52,085 Amortization of intangible 103,896 - Changes in operating assets and liabilities: Increase in trade receivables ( 17,387,446 ) - Increase in inventory ( 4,543,150 ) - Increase in prepaid expenses and other current assets ( 1,851,748 ) ( 1,756,105 ) (Decrease) increase in accounts payable ( 2,935,851 ) 183,903 Increase in accrued expenses 8,002,696 1,164,571 Decrease in operating lease liabilities ( 111,216 ) ( 99,486 ) Net cash used in operating activities ( 45,000,117 ) ( 27,663,786 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of short-term investments ( 21,475,457 ) ( 60,978,108 ) Maturity of short-term investments 43,116,192 43,350,000 Purchase of equipment ( 105,861 ) ( 31,369 ) Net cash provided by (used in) investing activities 21,534,874 ( 17,659,477 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from sale of common stock from at-the-market program, net 13,376,081 12,515,209 Payment of employee withholding taxes on vested restricted stock units ( 236,615 ) ( 198,442 ) Proceeds from public offering of common stock and pre-funded warrants, net - 42,878,399 Proceeds from exercise of stock options 1,894,285 253,988 Net cash provided by financing activities 15,033,751 55,449,154 Foreign exchange effect on cash ( 478 ) 385 NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS ( 8,431,970 ) 10,126,276 CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD 43,823,192 43,374,745 CASH, CASH EQUIVALENTS AND RES

Financial Statements

Financial Statements. 5 CORMEDIX INC. AND SUBSIDIARIES NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL Note 1 - Organization, Business and Basis of Presentation: Organization and Business CorMedix Inc. ("CorMedix" or the "Company") was incorporated in the State of Delaware on July 28, 2006 . The Company is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The Company's primary focus is on the commercialization of its lead product, DefenCath (taurolidine and heparin) in the United States, or U.S. The Company has in-licensed the worldwide rights to develop and commercialize DefenCath. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration, or FDA. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2024, or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or S

View Full Filing

View this 10-Q filing on SEC EDGAR