CorMedix Inc. (NASDAQ:CRMD) Q3 2021 Earnings Conference Call November 9, 2021 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors, IR Matt David - Interim CEO, EVP, and CFO Phoebe Mounts - EVP and General Counsel Conference Call Participants Jason Butler - JMP Securities Rohit Bhasin - Needham & Company Operator Good afternoon and welcome to the CorMedix's Third Quarter Earnings Conference Call. Today's conference call is being recorded. There will be a question-and-answer session At this time, all ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 20-5894890 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, $0.001 par value CRMD The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION RE ...

CorMedix Inc. (NASDAQ:CRMD) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors, IR Khoso Baluch - CEO Phoebe Mounts - EVP and General Counsel Matt David - EVP and CFO Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities Chad Messer - Needham & Company Operator Greetings and welcome to the CorMedix Inc. Second Quarter 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number 001-34673 CORMEDIX INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorpo ...

Financial Data and Key Metrics Changes - The net loss for Q1 2021 was approximately $7.2 million or $0.20 per share, compared to a loss of $5.6 million or $0.21 per share in Q1 2020, indicating an increase in net loss due to higher expenses related to DEFENCATH preparations [45][46] - Operating expenses increased approximately 29% to $7.2 million in Q1 2021 from $5.6 million in Q1 2020, with R&D expenses rising by 7% to $2.6 million and SG&A expenses increasing by 45% to $4.6 million [46][47] - Cash and equivalents stood at $81.2 million as of March 31, 2021, providing the company with the flexibility to address manufacturing issues and prepare for market entry [49] Business Line Data and Key Metrics Changes - The focus remains on the commercial launch of DEFENCATH, a catheter lock solution aimed at reducing catheter-related bloodstream infections in hemodialysis patients [8][51] - The company is also preparing for label expansion of DEFENCATH for use in TPN and oncology patients, indicating a strategic move to broaden its market reach [14][40] Market Data and Key Metrics Changes - The hemodialysis market represents a significant opportunity, with a large unmet medical need for antimicrobial solutions to prevent CRBSIs, as there are currently no approved pharmacological agents in the U.S. [52] - The potential for DEFENCATH to address life-threatening infections is emphasized, particularly in the context of the ongoing COVID-19 pandemic [85] Company Strategy and Development Direction - The company aims to resolve third-party manufacturing deficiencies, expand connections within the hemodialysis community, and prepare for the successful launch of DEFENCATH upon FDA approval [53] - There is a commitment to exploring label expansions for DEFENCATH beyond hemodialysis, targeting pediatric patients and those undergoing chemotherapy [40][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of DEFENCATH to meet significant clinical needs and emphasized the importance of reducing infection rates in patients [52][85] - The company is optimistic about the FDA's recognition of DEFENCATH's potential and is preparing for a resubmission of the NDA in Q4 2021 [27][30] Other Important Information - The company has appointed a new Chief Commercial Officer, Tom Nusbickel, to enhance its commercial strategy as it approaches the launch of DEFENCATH [9][11] - The FDA has provided guidance on remote interactive evaluations for pre-approval inspections, which may facilitate the review process [32][66] Q&A Session Summary Question: Confirmation on the manual extraction study and statistical analysis plan - Management confirmed the successful completion of the study as required by the FDA [56] Question: Timeline for additional in-process qualification work - The company has agreed on a plan with its CMO to resolve deficiencies and generate additional data required by the FDA [57] Question: Key activities ahead of the launch and marketing message for DEFENCATH - Management indicated that further details on the launch strategy would be provided as the new CCO familiarizes himself with existing plans [58][60] Question: Expected response timeline from the FDA after NDA resubmission - The timeline for FDA review will be determined at the time of NDA resubmission, with no specific information available at this time [64] Question: Discussions regarding virtual inspections with the FDA - The company has not had discussions regarding virtual inspections, as the guidance was released after their meeting with the FDA [66] Question: Need for re-approval of the CMO for pediatric studies - The label expansion will be filed as a supplement to the NDA, and the manufacturing facility would be subject to routine inspections by the FDA [69] Question: Clarification on the qualification processes and NDA submission timeline - Management explained the complexity of the manufacturing process and the need for robust data to meet FDA requirements [73][75]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 20-5894890 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file numb ...

& CorMedix™ Corporate Presentation April 2021 DefenCath™: A potentially new standard-of-care in the prevention of catheter related blood stream infections Forward-Looking Statements This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements are not guarantees of future performance a ...

CorMedix Inc. (NASDAQ:CRMD) Q4 2020 Earnings Conference Call March 30, 2021 4:30 PM ET Company Participants Dan Ferry - Investor Relations Khoso Baluch - Chief Executive Officer Phoebe Mounts - Executive Vice President & General Counsel Matt David - Executive Vice President & Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities Chad Messer - Needham & Company Andrew D'Silva - B. Riley & Company Operator Greetings. Welcome to the CorMedix Fourth Quar ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ______________________ Commission file number: 001-34673 CORMEDIX INC. (Exact name of Registrant as Specified in Its Charter) | --- | --- | |-------- ...

CorMedix Inc. (NASDAQ:CRMD) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants Dan Ferry - Investor Relations Khoso Baluch - Chief Executive Officer Phoebe Mounts - Executive Vice President and General Counsel Matt David - Executive Vice President and Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Operator Greetings and welcome to the CorMedix Inc. Third Quarter 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is be ...