CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Berkeley Heights, NJ – March 12, 2024 – 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. ● On November 15, 2023, CorMedix re ...

BERKELEY HEIGHTS, N.J., March 06, 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 conditions and diseases, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2023, before the market opens on Tuesday, March 12, 2024, and will host a corporate update conference call at 8:30am Eastern Time.  Tuesday, ...

BERKELEY HEIGHTS, N.J., March 06, 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 conditions and diseases, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2023, before the market opens on Tuesday, March 12, 2024, and will host a corporate update conference call at 8:30am Eastern Time.  Tuesday, ...

BERKELEY HEIGHTS, N.J., Jan. 30, 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 updates related to its business and anticipated launch of DefenCath®. Recent Updates: On January 25, 2024 the Center for Medicare & Medicaid Services (CMS) notified CorMedix that the agency has determined DefenCath will be eligible for reim ...

CorMedix Inc. (NASDAQ:CRMD) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - CEO Matt David - EVP and CFO Phoebe Mounts - EVP and General Counsel Conference Call Participants Jason Butler - JMP Securities Leszek Sulewski - Truist Securities Gregory Renza - RBC Capital Markets Operator Good afternoon, and welcome to CorMedix Third Quarter 2023 Earnings Conference Call. Today's call is being recorded. [Operator Instructions] At ...

As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the prespecified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safet ...

CorMedix Inc. (NASDAQ:CRMD) Q2 2023 Earnings Conference Call August 8, 2023 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Elizabeth Hulbert - EVP, Clinical and Medical Affairs Erin Mistry - Executive Vice President and Chief Commercial Officer Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Secur ...

PART I [Item 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) CorMedix Inc.'s H1 2023 unaudited financials show decreased assets, zero revenue, and a widened net loss, reflecting pre-revenue DefenCath focus [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$57.0 million** by June 30, 2023, from **$62.0 million** at year-end 2022, primarily due to reduced cash Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,700 | $43,148 | | Short-term investments | $32,701 | $15,644 | | Total current assets | $54,625 | $59,551 | | Total Assets | $57,033 | $62,038 | | **Liabilities & Equity** | | | | Total current liabilities | $7,387 | $6,311 | | Total Liabilities | $7,982 | $6,979 | | Total Stockholders' Equity | $49,051 | $55,060 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Zero revenue for Q2 and H1 2023, with operating expenses rising significantly, led to a **48-49% increase** in net losses year-over-year Statement of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $21 | $0 | $29 | | Total Operating Expenses | ($11,805) | ($8,261) | ($22,822) | ($15,300) | | Loss From Operations | ($11,805) | ($8,240) | ($22,822) | ($15,273) | | Net Loss | ($11,274) | ($7,605) | ($21,841) | ($14,639) | | Net Loss Per Share | ($0.25) | ($0.19) | ($0.49) | ($0.38) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to **$19.0 million** for H1 2023, with a **$23.5 million** net decrease in cash despite **$12.6 million** from financing activities Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,966) | ($12,206) | | Net cash used in investing activities | ($17,073) | ($3,593) | | Net cash provided by financing activities | $12,551 | $11,415 | | **Net Decrease in Cash** | **($23,486)** | **($4,398)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail DefenCath focus, sufficient liquidity for twelve months including July 2023 offering proceeds, and ongoing legal proceedings related to NDA submissions - The company believes existing cash, short-term investments, and July 2023 public offering proceeds are sufficient to fund operations for at least **twelve months** from the filing date[81](index=81&type=chunk) - A consolidated class action lawsuit alleges securities law violations related to allegedly false statements about DefenCath NDA submissions[147](index=147&type=chunk) - In July 2023, a public offering and underwriters' option exercise raised approximately **$43.2 million** in net proceeds[171](index=171&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses DefenCath's regulatory progress, including NDA resubmission, and financial performance, noting zero revenue, increased losses, and sufficient liquidity for future operations [Overview](index=25&type=section&id=Overview) The company focuses on DefenCath development, resubmitting its NDA in May 2023 with an FDA target review date of November 15, 2023, and securing a conditional NTAP from CMS - CorMedix resubmitted the NDA for DefenCath on **May 15, 2023**, addressing prior manufacturing deficiencies[212](index=212&type=chunk) - The FDA accepted the NDA resubmission as a Class 2 response, setting a target action date of **November 15, 2023**[212](index=212&type=chunk) - CMS included a New Technology Add-On Payment (NTAP) of up to **$17,111** per hospital stay for DefenCath in its 2024 proposed rule, conditional on FDA approval before **July 1, 2024**[243](index=243&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Zero revenue for Q2 and H1 2023 due to discontinued Neutrolin sales, while R&D and SG&A expenses significantly increased by **49%** and **49%** respectively, widening the net loss Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $21 | $0 | $29 | | R&D Expense | ($4,795) | ($3,209) | ($8,202) | ($5,497) | | SG&A Expense | ($7,010) | ($5,052) | ($14,620) | ($9,803) | | Net Loss | ($11,274) | ($7,605) | ($21,841) | ($14,639) | - The **49%** increase in R&D expense for the six months ended June 30, 2023 was driven by higher costs for DefenCath manufacturing (**$915k**), personnel expenses (**$1.06M**), and medical affairs activities (**$542k**)[11](index=11&type=chunk) - The **49%** increase in SG&A expense for the six months ended June 30, 2023 was primarily due to market research and pre-launch activities for DefenCath (**$3.65M**) and increased personnel costs (**$937k**)[12](index=12&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held **$52.4 million** in cash and investments, with **$19.0 million** net cash used in operations, but believes current resources and July 2023 offering proceeds are sufficient for twelve months - Total cash on hand and short-term investments was **$52.4 million** as of **June 30, 2023**, compared to **$58.8 million** at **December 31, 2022**[18](index=18&type=chunk) - Net cash used in operating activities increased by **$6.8 million** to **$19.0 million** for the six months ended **June 30, 2023**, compared to the same period in 2022, primarily due to a higher net loss[17](index=17&type=chunk) - Management estimates that current cash resources, plus net proceeds from the July 2023 public offering, will fund operations for at least **twelve months** from the filing date and support the DefenCath launch to anticipated profitability[231](index=231&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's market risk is primarily limited to interest rate fluctuations on its **$52.4 million** cash and investment portfolio, with no material impact expected from interest rate changes - The company's primary market risk exposure is from interest rate fluctuations on its portfolio of cash, cash equivalents, and short-term investments[234](index=234&type=chunk) - As of **June 30, 2023**, the company held **$52.4 million** in cash, cash equivalents, and short-term investments[21](index=21&type=chunk) - Management does not believe the company is materially exposed to changes in interest rates and estimates a **1%** unfavorable change would not have a material effect on interest expense[21](index=21&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2023, the CEO and CFO concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that as of **June 30, 2023**, the company's disclosure controls and procedures were effective[29](index=29&type=chunk) - No changes were made to the company's internal control over financial reporting during the quarter ended **June 30, 2023**, that materially affected or are likely to materially affect internal controls[271](index=271&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Details on the company's legal proceedings are incorporated by reference from Note 4, 'Commitments and Contingencies,' within the financial statements - Details on legal proceedings are incorporated by reference from Note 4 of the financial statements in Part I, Item 1 of this report[237](index=237&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This report updates risk factors from the Annual Report on Form 10-K for the year ended December 31, 2022, covering financial position, product development, industry, intellectual property, and third-party dependence - The report updates risk factors from the Annual Report on Form 10-K for the year ended **December 31, 2022**, and should be read in conjunction with it[24](index=24&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2023 - No director or officer adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the three months ended **June 30, 2023**[26](index=26&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) The report includes an exhibit index listing all filed documents, including Pre-Funded Warrant forms, Sarbanes-Oxley certifications, and Inline XBRL documents - The exhibit index is incorporated by reference, listing certifications and XBRL data files as exhibits[33](index=33&type=chunk)

CorMedix Inc. (NASDAQ:CRMD) Q1 2023 Earnings Call May 15, 2023 4:30 PM ET Company Participants Joe Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Erin Mistry - Executive Vice President and Chief Commercial Officer Conference Call Participants Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the CorMedix First Quarter 2023 Earnings Conference Call. All participants will ...

PART I FINANCIAL INFORMATION [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited financial statements for the quarter ended March 31, 2023, including balance sheets, statements of operations, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (Unaudited, in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $25,268 | $43,148 | | Short-term investments | $30,332 | $15,644 | | Total current assets | $56,781 | $59,551 | | **Total Assets** | **$59,234** | **$62,038** | | **Liabilities & Equity** | | | | Total current liabilities | $4,675 | $6,311 | | **Total Liabilities** | **$5,306** | **$6,979** | | **Total Stockholders' Equity** | **$53,928** | **$55,060** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statements of Operations (Unaudited, in millions, for the three months ended March 31) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net sales | $0.00 | $0.01 | | Gross profit | $0.00 | $0.01 | | Research and development | ($3.41) | ($2.29) | | Selling, general and administrative | ($7.61) | ($4.75) | | Loss From Operations | ($11.02) | ($7.03) | | **Net Loss** | **($10.57)** | **($7.03)** | | **Net Loss Per Share (Basic & Diluted)** | **($0.24)** | **($0.18)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Statements of Cash Flows (Unaudited, in millions, for the three months ended March 31) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($10.39) | ($6.74) | | Net cash used in investing activities | ($14.69) | ($4.19) | | Net cash provided by financing activities | $7.20 | $3.00 | | **Net Decrease in Cash** | **($17.88)** | **($7.93)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company's existing cash, cash equivalents, and short-term investments of **$55.6 million** as of March 31, 2023, are expected to fund operations at least through the **first half of 2024**. Continued operations depend on raising additional capital[205](index=205&type=chunk)[141](index=141&type=chunk)[151](index=151&type=chunk) - The company is involved in multiple shareholder derivative lawsuits, which have been consolidated, alleging breaches of fiduciary duties related to the DefenCath NDA submissions, with the case currently stayed pending resolution of a related class action lawsuit[211](index=211&type=chunk)[45](index=45&type=chunk)[35](index=35&type=chunk) - Patent infringement litigation against TauroPharm in Germany has been largely concluded, with the company withdrawing its infringement action regarding the Prosl European Patent after an unfavorable view from the EPO Board of Appeals and bearing the costs of the proceedings[49](index=49&type=chunk)[217](index=217&type=chunk) - During Q1 2023, the company sold **1,684,592 shares** of common stock under its At-The-Market (ATM) program, realizing net proceeds of **$7.2 million**, with approximately **$24.2 million** remaining available under the ATM program as of March 31, 2023[228](index=228&type=chunk)[59](index=59&type=chunk) - Subsequent to the quarter end, through May 5, 2023, the company sold an additional **849,476 shares** under the ATM program for net proceeds of approximately **$3.7 million**[234](index=234&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing and commercializing DefenCath, including its complex regulatory history with the FDA, and details increased operating expenses and net loss for Q1 2023 [Overview](index=23&type=section&id=Overview) - The company's lead product candidate is **DefenCath™**, a novel anti-infective catheter lock solution for preventing catheter-related infections and thrombosis in patients requiring central venous catheters[86](index=86&type=chunk) - The FDA issued a **second Complete Response Letter (CRL)** in **August 2022** for the DefenCath NDA, citing deficiencies at the contract manufacturing organization (CMO) and the heparin API supplier, with no additional clinical data requested from CorMedix[82](index=82&type=chunk) - Following an April 2023 meeting with the FDA, the company plans to resubmit the NDA by **mid-May 2023**, with the resubmission expected to have a **six-month Class 2 review cycle** and include data from both existing and alternative heparin API suppliers[84](index=84&type=chunk) - CMS issued a proposed rule for a **New Technology Add-On Payment (NTAP)** for DefenCath of **up to $17,111** per hospital stay, contingent on FDA approval before **July 1, 2024**[94](index=94&type=chunk) - The company was granted a new **U.S. patent (No. 17/721,699)** for DefenCath's formulation, potentially providing patent protection through **2042**[107](index=107&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Comparison of Results for the Three Months Ended March 31, 2023 and 2022 (in thousands) | Item | Q1 2023 | Q1 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 thousand | $8 thousand | ($8 thousand) | (100)% | | R&D Expense | $3,407 thousand | $2,288 thousand | $1,119 thousand | 49% | | SG&A Expense | $7,610 thousand | $4,751 thousand | $2,859 thousand | 60% | | Loss from Operations | ($11,017 thousand) | ($7,033 thousand) | ($3,984 thousand) | 57% | | Net Loss | ($10,568 thousand) | ($7,034 thousand) | ($3,534 thousand) | 50% | - R&D expenses increased by **49% YoY**, primarily due to higher personnel expenses (**$588 thousand**), medical affairs activities (**$300 thousand**), and pre-approval manufacturing costs (**$192 thousand**)[130](index=130&type=chunk) - SG&A expenses increased by **60% YoY**, mainly driven by increased costs for market research and pre-launch activities (**$1.9 million**), higher personnel expenses (**$511 thousand**), and increased non-cash stock-based compensation (**$892 thousand**)[131](index=131&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - Total cash, cash equivalents, and short-term investments were **$55.6 million** at **March 31, 2023**, down from **$58.8 million** at **December 31, 2022**[151](index=151&type=chunk) - Net cash used in operating activities increased to **$10.4 million** in **Q1 2023** from **$6.7 million** in **Q1 2022**, driven by a higher net loss and increased operating expenses[119](index=119&type=chunk) - The company raised **$7.2 million** in net proceeds from its ATM program in **Q1 2023**, compared to **$3.0 million** in **Q1 2022**[138](index=138&type=chunk)[118](index=118&type=chunk) - Management estimates current cash is sufficient to fund operations at least through the **first half of 2024**, with additional financing needed to build out commercial infrastructure if DefenCath is approved[141](index=141&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) This section addresses the company's exposure to market risks, specifically interest rate and inflation risk, noting no material effect on financial results - The company's primary market risk is from interest rate fluctuations, but due to the short-term nature of its investment portfolio, a **10% change** in interest rates is not expected to have a material effect[144](index=144&type=chunk)[145](index=145&type=chunk) - Inflation is not believed to have had a material effect on the company's business, financial condition, or results of operations during **Q1 2023**[147](index=147&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of **March 31, 2023**[153](index=153&type=chunk) - There were no changes in internal control over financial reporting during the **first quarter of 2023** that materially affected, or are reasonably likely to materially affect, internal controls[154](index=154&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 4 of the financial statements for details on legal proceedings, primarily involving shareholder derivative lawsuits and patent litigation - For information regarding legal proceedings, the report refers to **Note 4**, "Commitments and Contingencies," in **Part I, Item 1**[148](index=148&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes from the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022 - There were **no material changes** from the risk factors previously disclosed in the company's **Annual Report on Form 10-K** for the year ended **December 31, 2022**[166](index=166&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Form 10-Q, including indemnification agreements and Sarbanes-Oxley Act certifications List of Exhibits | Exhibit No. | Description | | :--- | :--- | | 10.1*+ | Form of Indemnification Agreement between the Company and each of its directors and executive officers | | 31.1* | Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 31.2* | Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 32.1* | Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 32.2* | Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 101 Series | Inline XBRL Documents |