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.

CorMedix reports strong Q3 results, eyes FDA approvals for growth

CorMedix's Q3 performance exceeded expectations, showing revenue growth and operational improvements.
While facing challenges in revenue guidance variability and increased expenses, the company is poised for EBITDA positivity in Q4.
Strengths lie in product acceptance, market expansion, and commitment to research, with opportunities in new agreements, studies, and FDA approvals.
Careful financial management and successful regulatory milestones will be key to capitalizing on growth opportunities and maintaining profitability.

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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., 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

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 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.

CorMedix to Participate at the JMP Securities Life Sciences Conference

CorMedix Inc. (NASDAQ:CRMD ) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Daniel Ferry - Investor Relations Joe Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Erin Mistry - Senior Vice President and Head, Payer Strategy, Government Affairs and Trade Conference Call Participants Jason Butler - JMP Securities Rohit Bhasin - Needham & Company Operator Hello and welcome to the CorMedix Inc. First Quarter 2022 Earnings Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

CorMedix Inc. (CRMD) CEO Joe Todisco on Q1 2022 Results - Earnings Call Transcript

CorMedix (CRMD) delivered earnings and revenue surprises of 21.74% and 84%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

CorMedix (CRMD) Reports Q1 Loss, Lags Revenue Estimates

Conference Call Scheduled for Today at 4:30 p.m. Eastern Time Conference Call Scheduled for Today at 4:30 p.m. Eastern Time

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

BERKELEY HEIGHTS, N.J., May 12, 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 updates regarding its leadership team and changes regarding its international operations:

CorMedix Inc. Announces Leadership Updates and Operational Changes

BERKELEY HEIGHTS, N.J. , May 03, 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 it will report its financial results for the first quarter ended March 31, 2022, after the market close on Thursday, May 12, 2022, and will host a corporate update conference call at 4:30pm Eastern Time.

CorMedix Inc. to Report First Quarter 2022 Financial Results and Provide a Corporate Update on May 12

BERKELEY HEIGHTS, N.J., April 07, 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 the formation of a new Scientific Advisory Board (SAB) comprised of esteemed experts in nephrology, infectious disease, medical nutrition, and pediatric oncology. The SAB's mission will be to provide strategic and scientific advice as CorMedix advances DefenCath™ toward a potential commercial launch and looks to pursue DefenCath lifecycle expansion opportunities.

CorMedix Inc. Announces Scientific Advisory Board to Support Commercialization and Pipeline Development

BERKELEY HEIGHTS, N.J., April 04, 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 presenting a corporate overview at the 21st Annual Needham Virtual Healthcare Conference being held April 11 – 14, 2022.

CorMedix Inc. to Present at the 21st Annual Needham Virtual Healthcare Conference

CorMedix Inc. (CRMD) CEO Matt David on Q4 2021 Results - Earnings Call Transcript

CorMedix (CRMD) delivered earnings and revenue surprises of 9.09% and 40%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

CorMedix (CRMD) Reports Q4 Loss, Tops Revenue Estimates

CorMedix Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

CorMedix (CRMD) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

CorMedix (CRMD) Stock Jumps 14.8%: Will It Continue to Soar?

BERKELEY HEIGHTS, N.J., March 22, 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 it will report its financial results for the fourth quarter and year ended December 31, 2021, after the market close on Tuesday, March 29, 2022, and will host a corporate update conference call at 4:30pm Eastern Time.

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