CorMedix Inc. (NASDAQ:CRMD) Q1 2024 Results Conference Call May 9, 2024 8:30 AM ET Company Participants Dan Ferry - LifeSci Advisors Joe Todisco - Chief Executive Officer Matt David - EVPr and CFO Beth Zelnick Kaufman - EVP and Chief Legal Officer Liz Hurlburt - EVP and Chief Clinical Strategy and Operations Officer Erin Mistry - EVP and Chief Commercial Officer Conference Call Participants Les Sulewski - Truist Securities Operator Good morning, and welcome to the CorMedix First Quarter 2024 Earnings Confer ...

BERKELEY HEIGHTS, N.J., May 10, 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 management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 13 – 14, 2024 and the 2024 RBC Capital Markets Global Healthcare Conference being held in New York on May 14 – 1 ...

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]