CorMedix

CorMedix, Inc. operates as a pharmaceutical and medical device company. The firm seeks to license, develop and commercialize prophylactic and therapeutic products for the prevention and treatment of infectious and inflammatory diseases. It is developing its product Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. The company was founded by Antony E. Pfaffle in 2006 and is headquartered in Berkeley Heights, NJ.

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CorMedix progresses on DefenCath NDA resubmission amidst financial challenges

CorMedix is actively working towards resubmitting the DefenCath NDA and preparing for commercialization, despite facing challenges in FDA interactions and financial performance. The company's strong cash position provides operational flexibility and readiness for potential NDA approval, with opportunities for growth in addressing CRBSIs.

CorMedix plans DefenCath launch in 2024, strengthens IP protection

CorMedix is strategically positioning for the potential commercial launch of DefenCath in early 2024, pending FDA approvals.
Despite financial challenges in Q1 2023, the company's strong IP protection and engagement strategies offer growth opportunities.

CorMedix reports key milestones and strong financial position in Q2 2023

CorMedix's Q2 2023 Earnings Call highlighted key achievements, financial updates, and strategic initiatives, showcasing the company's progress and readiness for upcoming milestones.
Despite facing challenges such as a net loss increase and operational complexities, CorMedix's strong financial position, milestones achieved, and strategic focus position it well for future growth and success.
With opportunities to drive commercialization, expand market access, and establish partnerships, CorMedix is poised to capitalize on its strengths and navigate challenges effectively in the evolving healthcare landscape.

CorMedix prepares for DefenCath launch with strong cash position

CorMedix is strategically positioned for the commercial launch of DefenCath, with a strong cash position and ongoing discussions with regulatory bodies for reimbursement. Despite challenges in operating expenses and net loss in Q3 2023, the company's focus on key catalysts in 2024 presents significant growth opportunities.

CorMedix reports Q4 loss, eyes profitability in 2024 amid milestones

CorMedix faces challenges with rising operating expenses impacting profitability but has achieved key milestones and optimized field operations.
Opportunities lie in label expansions, reimbursement approvals, and gradual market penetration strategies.
Maintaining financial discipline while pursuing growth initiatives will be crucial for CorMedix's success.
Overall, CorMedix's strategic focus on commercial launch and potential expansions sets the stage for future growth.

CorMedix progresses with DefenCath launch, eyes profitability by 2024

CorMedix is making strides with DefenCath's commercial launch and engaging key dialysis providers for procurement contracts.
Financially, the company aims for breakeven by end of 2024, supported by a credit facility and ample cash reserves.
Challenges include managing operating expenses and evaluating potential M&A opportunities for strategic growth.
Opportunities lie in outpatient commercialization, label expansion, and demonstrating DefenCath's value through real-world evidence studies.

CorMedix sees strong sales growth with DefenCath launch success

CorMedix's successful DefenCath launch generated $5.2 million in sales, with inpatient sales expected to rise in Q4. The company is focused on securing reimbursement from Medicare Advantage plans and funding clinical initiatives without significant dilution.

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CorMedix, Inc. is a pharmaceutical and medical device company, which engages in the development and commercialization of therapeutic products for the prevention and treatment of diseases and conditions. The company was founded by Antony E. Pfaffle on July 28, 2006 and is headquartered in Berkeley Heights, NJ.

BERKELEY HEIGHTS, N.J., May 16, 2023 (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 that the New Drug Application for DefenCath was resubmitted to the U.S. Food and Drug Administration, and the submission has been acknowledged as received for processing.

CorMedix Inc. Announces Resubmission of New Drug Application for DefenCath

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 be in a listen-only mode.

CorMedix Inc. (CRMD) Q1 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., May 08, 2023 (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 first quarter ended March 31, 2023, after market close on Monday, May 15, 2023, and will host a corporate update conference call at 4:30pm Eastern Time.

CorMedix Inc. To Report First Quarter 2023 Financial Results and Provide a Corporate Update on May 15, 2023

BERKELEY HEIGHTS, N.J., May 01, 2023 (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 that the United States Patent and Trademark Office (USPTO) allowed its patent claims directed to the composition of a catheter lock solution for preventing infection and also preventing reduced blood flow in central venous catheters. CorMedix's newly allowed U.S. Patent Application (No. 17/721,699) reflects the unique and proprietary formulation of its product, DefenCath™, for which the Company expects to resubmit its New Drug Application (NDA) to the Food and Drug Administration (FDA) by mid-May.

CorMedix Inc. Announces Notice of Allowance for U.S. Patent Application Covering Lead Product DefenCath

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After losing some value lately, a hammer chart pattern has been formed for CorMedix (CRMD), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Here's Why CorMedix (CRMD) Looks Ripe for Bottom Fishing

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BERKELEY HEIGHTS, N.J., April 17, 2023 (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 the appointment of Robert A. Stewart to the CorMedix Board of Directors. Following the appointment of Mr. Stewart, the Board will comprise 8 directors, 7 of which are independent.

Cormedix Inc. Announces Appointment of Robert A. Stewart to Its Board of Directors

The average of price targets set by Wall Street analysts indicates a potential upside of 198.2% in CorMedix (CRMD). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

How Much Upside is Left in CorMedix (CRMD)? Wall Street Analysts Think 198.21%

CorMedix Inc. (NASDAQ:CRMD ) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET Company Participants Dan Ferry – Managing Director-LifeSci Advisors 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 Jason Butler – JMP Securities Joon Lee – Truist Securities Serge Belanger – Needham & Co. Operator Greetings, and welcome to the CorMedix Inc. Fourth Quarter and Full Year 2022 Earnings Call. At this time, all participants are in a listen-only mode.

CorMedix Inc. (CRMD) Q4 2022 Earnings Call Transcript

Conference Call Scheduled for Today at 8:30 a.m. Eastern Time Conference Call Scheduled for Today at 8:30 a.m. Eastern Time

CorMedix Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

BERKELEY HEIGHTS, N.J., March 21, 2023 (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 year ended December 31, 2022, before the market opens on Thursday, March 30, 2023, and will host a corporate update conference call at 8:30am Eastern Time.

Cormedix Inc. to Report Fourth Quarter and Fiscal Year 2022 Financial Results and Provide a Corporate Update on March 30, 2023

BERKELEY HEIGHTS, N.J., March 02, 2023 (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 the FDA compliance remediation activities at its primary contract manufacturing organization (“CMO”) and heparin active pharmaceutical ingredient (“API”) supplier, as well as updated timelines for potential resubmission of its New Drug Application (“NDA”) under various scenarios. More specifically:

CorMedix Inc. Announces Regulatory and Manufacturing Updates

BERKELEY HEIGHTS, N.J., Jan. 17, 2023 (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 the following promotions within the organization:

CorMedix Inc. Announces Promotions in Commercial and Tech Ops

BERKELEY HEIGHTS, N.J., Dec. 06, 2022 (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 the abstract publication and poster presentation at the American Society of Health-System Pharmacists (ASHP) conference in Las Vegas, Nevada, December 4 – 8.

Cormedix Inc. Announces Presentation at Conference Showing Mortality Risk and Complications in Patients Experiencing Catheter Related Blood Stream Infections

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CorMedix Inc. (NASDAQ:CRMD ) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Joe Todisco - Chief Executive Officer Matt David - Executive Vice President, Chief Financial Officer Phoebe Mounts - Executive Vice President, General Counsel Erin Mistry - Senior Vice President, Commercial Daniel Ferry - LifeSci Advisors Conference Call Participants Assam - Truist Securities Jason Butler - JMP Securities Serge Belanger - Needham & Co. Operator Good morning and welcome to the CorMedix Inc. third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode.

CorMedix (CRMD) Q3 2022 Earnings Call Transcript

CorMedix Inc. Reports Third Quarter 2022 Financial Results and Provides Business Update

BERKELEY HEIGHTS, N.J., Nov. 07, 2022 (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 the Center for Medicare & Medicaid Services (CMS) has published in the Federal Register a correction to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals New Technology Add on Payment (NTAP) reimbursement of DefenCath, increasing the maximum reimbursement per average hospital visit from $4,387.50 to $14,259.38. The original NTAP calculation by CMS was based upon 3 vials of DefenCath being utilized for catheter lock during 3 sessions of dialysis. The revised NTAP reimbursement is based upon a longer duration of hospital stay in which an estimated average of 9.75 vials of DefenCath would be utilized. The NTAP reimbursement for DefenCath is calculated by CMS as 75% of the expected Wholesale Acquisition Cost (WAC) of the product, and is conditioned upon final approval of the DefenCath New Drug Application by the Food and Drug Administration (FDA) prior to July 1st of 2023. The company also announced today the recent submission of a duplicate NTAP application to CMS, intended to take effect should final approval of the DefenCath NDA by FDA occur after July 1st of 2023.

CorMedix Inc. Announces CMS Revision to NTAP Reimbursement of DefenCath

BERKELEY HEIGHTS, N.J. , Nov. 02, 2022 (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 third quarter ended September 30, 2022, before the market open on Thursday, November 10, 2022, and will host a corporate update conference call at 8:30am Eastern Time.

CorMedix Inc. to Report Third Quarter 2022 Financial Results and Provide a Corporate Update on November 10

BERKELEY HEIGHTS, N.J., Oct. 20, 2022 (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 an abstract has been accepted for presentation at the American Society of Nephrology (ASN) annual meeting being held in Orlando, Florida, November 3 – 6.

CorMedix Inc. Announces Abstract Presentation at Upcoming American Society of Nephrology Conference

CorMedix Inc. (NASDAQ:CRMD ) Q2 2022 Earnings Conference Call August 11, 2022 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors, LLC Erin Mistry - Senior Vice President and Head, Payer Strategy, Government Affairs and Trade Joseph Todisco - Chief Executive Officer Matt David - Executive Vice President & Chief Financial Officer Phoebe Mounts - Executive Vice President & General Counsel Conference Call Participants Rohit Bhasin - Needham & Co. Operator Greetings and welcome to the CorMedix Inc. Second Quarter 2022 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

CorMedix Inc. (CRMD) CEO Joseph Todisco on Q2 2022 Results - Earnings Call Transcript

CorMedix Inc. Reports Second Quarter and Six Month 2022 Financial Results and Provides Business Update

Bad news on the regulatory front leads investors to bail en masse from the company.

Why CorMedix Stock Was Plummeting on Tuesday

BERKELEY HEIGHTS, N.J., June 08, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that management will be participating in a fireside chat at the JMP Securities Life Sciences Conference being held in New York on June 15 – 16, 2022.

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