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., July 03, 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 commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath as directed by the Center for Medicare & Medicaid Services (CMS).

CorMedix Inc. Announces Outpatient Availability of DefenCath

BERKELEY HEIGHTS, N.J., June 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 the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years.

CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath

BERKELEY HEIGHTS, N.J., May 28, 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 multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin).

CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider

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 Conference Call [Operator Instructions]. Today's conference call is being recorded.

CorMedix Inc. (CRMD) Q1 2024 Earnings Call Transcript

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 – 15, 2024. Details for each fireside chat are as follows:

CorMedix Inc. to Participate in Two Upcoming Investor Conferences

BERKELEY HEIGHTS, N.J., May 09, 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 financial results for the first quarter ended March 31, 2024 and provided an update on its business.

CorMedix Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

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.

CorMedix Inc. To Report First Quarter 2024 Financial Results and Provide a Corporate Update on May 9, 2024

The mean of analysts' price targets for CorMedix (CRMD) points to a 135.5% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Does CorMedix (CRMD) Have the Potential to Rally 135.51% as Wall Street Analysts Expect?

BERKELEY HEIGHTS, N.J., April 19, 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 the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category, beginning on July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers, and aligns with CorMedix's upcoming outpatient launch in July.

CorMedix Inc. Announces CMS Grants TDAPA to DefenCath

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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.

CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)

The mean of analysts' price targets for CorMedix (CRMD) points to a 146.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Predict a 146.21% Upside in CorMedix (CRMD): Here's What You Should Know

BERKELEY HEIGHTS, N.J., April 11, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that two abstracts have been accepted for presentation at the Society for Healthcare Epidemiology of America (SHEA) conference being held in Houston, Texas, April 16 – 19, 2024.

CorMedix Inc. Announces Abstracts at Upcoming Society for Healthcare Epidemiology of America Conference

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 Inc. Announces Commercial Agreement With ARC Dialysis, LLC

CorMedix Inc. (NASDAQ:CRMD ) Q4 2023 Earnings Conference Call March 12, 2024 8:30 AM ET Company Participants Joe Todisco - Chief Executive Officer Matt David - Executive Vice President, Chief Financial Officer Erin Mistry - Executive Vice President, Chief Commercial Officer Liz Hurlburt - Executive Vice President, Chief Clinical Strategy and Operations Officer Dan Ferry - LifeSci Advisors Conference Call Participants Jason Butler - Citizens JMP Anish Nikhanj - RBC Capital Markets Lew Sulewski - Truist Securities Serge Belanger - Needham & Co. Operator Good morning ladies and gentlemen, and welcome to the CorMedix Inc. fourth quarter and full year 2023 earnings call. At this time, all lines are in a listen-only mode.

CorMedix (CRMD) Q4 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., March 12, 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 financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business.

CorMedix Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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.

CorMedix Inc. to Report Fourth Quarter and Full Year 2023 Financial Results and Provide a Corporate Update on March 12, 2024

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®.

CorMedix Inc. Announces Commercial and Reimbursement Updates

BERKELEY HEIGHTS, N.J., Jan. 08, 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 several commercial and operational updates related to its business and anticipated launch of DefenCath®.

CorMedix Inc. Announces Commercial and Operational Updates

BERKELEY HEIGHTS, N.J., Dec. 15, 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 the appointment of Beth Zelnick Kaufman, Esq. as EVP, Chief Legal Officer, and Corporate Secretary, effective December 12, 2023. The Company also announced that, upon mutual agreement with the Company, Dr. Phoebe Mounts will no longer serve as the Company's General Counsel, effective December 12, 2023, and will be separating from CorMedix effective December 31, 2023, to pursue other opportunities.

CorMedix Inc. Announces Appointment of Chief Legal Officer

– CorMedix to advocate for patient safety and infection prevention as part of  Leapfrog's Partners Advisory Committee

CorMedix Inc. Announces Partnership With The Leapfrog Group

– First and only FDA-approved antimicrobial catheter lock solution in the U.S. – Company expects DefenCath to be available in Q1 2024 in the inpatient setting BERKELEY HEIGHTS, N.J., Nov. 15, 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 U.S. Food and Drug Administration (FDA) has approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).

CorMedix Inc. Announces FDA Approval of DefenCath® to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients

The U.S. Food and Drug Administration (FDA) on Wednesday approved CorMedix's antimicrobial drug that aims to reduce catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, the regulator said.

U.S. FDA approves CorMedix's antimicrobial drug

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.

CorMedix Inc. (CRMD) Q3 2023 Earnings Call Transcript

BERKELEY HEIGHTS, N.J., Nov. 14, 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 financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events.

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