Annonce • May 05
CorMedix Inc. to Report Q1, 2026 Results on May 14, 2026 CorMedix Inc. announced that they will report Q1, 2026 results Pre-Market on May 14, 2026 Annonce • Apr 29
Cormedix Therapeutics Announces Positive Topline Results from Phase III Respect Trial Assessing Rezzayo for the Prophylaxis of Invasive Fungal Diseases in Allogeneic Hematopoietic Stem Cell Transplantation Patients CorMedix Therapeutics announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The ReSPECT Phase III study, one of the largest anti-fungal multicenter, randomized, double-blind studies evaluated the efficacy and safety of once weekly rezafungin (rezafungin acetate) compared with a standard antimicrobial regimen (SAR) for the prophylaxis of invasive fungal diseases, including infections caused by Candida, Aspergillus, and Pneumocystis, in adults undergoing allogeneic HSCT. Patients undergoing allogeneic blood and marrow transplantation face prolonged periods of immunosuppression and routinely require extended antifungal prophylaxis, representing a setting where differentiated dosing, improved side effect profile, and reduced DDI is beneficial, and comparable efficacy is expected. The ReSPECT study met its primary endpoint for FDA and EMA for fungal-free survival at Day 90 showing non-inferiority vs. SAR, with 60.7% fungal-free survival at Day 90 for rezafungin compared to 59.0% for standard antimicrobial regimen. This demonstrates that rezafungin’s differentiated pharmacokinetics/pharmacodynamics (PK/PD) profile was comparable to the standard antimicrobial regimen (SAR) in reducing the incidence of invasive fungal infections in a high-risk patient population. Rezafungin was well tolerated, with a safety profile showing a favorable benefit/risk profile for immunocompromised patients. The Phase III study topline results demonstrated comparable efficacy against invasive infections from candida, aspergillus and pneumocystis in both therapeutic arms, as well as comparable mortality. In addition, results showed a favorable profile in multiple secondary endpoints, most notably treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drug, and treatment emergent adverse events leading to study discontinuation. This clinical trial has been sponsored by Mundipharma. Mundipharma has commercial rights to rezafungin outside the U.S. Mundipharma has partnered with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix for US distribution of rezafungin. The companies anticipate a pre-NDA submission meeting with FDA in the coming months, followed by a target submission of a supplemental New Drug Application (sNDA) to the FDA in Second Half 2026 based on the ReSPECT results. Rezafungin is a next generation echinocandin approved for the treatment of candidemia and invasive candidiasis in adults. Invasive candidiasis continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. Rezafungin has been studied for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT. CorMedix estimates that the potential US market opportunity for REZZAYO in prophylaxis exceeds $2 billion, based on internal analyses and assumptions. These estimates are forward-looking statements and are subject to regulatory approvals, clinical practice considerations, and market adoption. Rezafungin has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. REZZAYO is a Registered Trademark of Mundipharma, used under license by Melinta Therapeutics LLC, a wholly owned subsidiary of CorMedix in the US. Annonce • Apr 21
CorMedix Inc., Annual General Meeting, Jun 23, 2026 CorMedix Inc., Annual General Meeting, Jun 23, 2026. Annonce • Mar 05
CorMedix Inc. Reiterates Earnings Guidance for the Year 2026 CorMedix reiterated earnings guidance for the year 2026. For the year, company reiterated previously established guidance for 2026, including net revenue of between $300 and $320 million . Annonce • Mar 02
CorMedix Inc. to Report Q4, 2025 Results on Mar 05, 2026 CorMedix Inc. announced that they will report Q4, 2025 results Pre-Market on Mar 05, 2026 Annonce • Feb 03
CorMedix Inc. (NasdaqGM:CRMD) announces an Equity Buyback for $75 million worth of its shares. CorMedix Inc. (NasdaqGM:CRMD) announces a share repurchase program. Under the program, the company will repurchase up to $75 million worth of its outstanding common stock. The repurchase program is authorized through December 31, 2027. Annonce • Dec 18
Cormedix Therapeutics Announces Positive Data from Ongoing Real World Evidence Study of Defencath CorMedix Therapeutics announced interim results for the Company's ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care's (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters. CorMedix and USRC commenced the real-world evidence study upon outpatient commercial launch in July 2024. The study is designed to demonstrate the impact of the broad use of DefenCath in a real-world setting and prospectively assess rates of catheter-related bloodstream infections (CRBSI), as well as hospitalizations secondary to these infections. The study is designed to evaluate these data points for two years. Currently, more than 3,000 patients per month are receiving DefenCath on a routine basis at USRC facilities. The company believe this data also strongly reinforces the ongoing collaborations among healthcare providers, patient advocates and elected leaders committed to transforming status quo dialysis care by addressing the long-standing and unmet need for infection prevention measures that lower hospitalizations, reduce healthcare utilization and limit costs to taxpayers. Secondary data points of missed treatment sessions, antibiotic utilization, and tPA utilization are also being assessed and may be announced with additional real-world evidence data in the future. CorMedix believes these data from this large, prospective, ongoing real-world study further underscore the LOCK-IT 100 clinical study results on which the FDA approval of DefenCath for ESRD hemodialysis patients was based. The Company expects to continue to discuss with customers and payors, such as Medicare Advantage plans, to emphasize the economic value of long-term infection prevention in these patients. Annonce • Oct 31
CorMedix Inc. to Report Q3, 2025 Results on Nov 12, 2025 CorMedix Inc. announced that they will report Q3, 2025 results Pre-Market on Nov 12, 2025 Annonce • Sep 30
CorMedix Announces Completion of Enrollment in Phase III ReSPECT Clinical Trial for REZZAYO CorMedix Inc. announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO®? (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebo matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S.REZZAYO is currently being studied for the prevention of invasive fun Gal diseases in adults undergoing allogeneicBMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market ("TAM") of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. Annonce • Aug 08
CorMedix Inc. (NasdaqGM:CRMD) agreed to acquire an unknown majority stake in Melinta Therapeutics, LLC from Deerfield Management Company, L.P. for approximately $330 million. CorMedix Inc. (NasdaqGM:CRMD) agreed to acquire an unknown majority stake in Melinta Therapeutics, LLC from Deerfield Management Company, L.P. for approximately $330 million on August 7, 2025. A cash consideration of $260 million will be paid by CorMedix Inc. As part of consideration, $325 million is paid towards common equity of Melinta Therapeutics, LLC.
The transaction is subject to approval by regulatory board. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the ‘HSR Act’). The Company expects the transaction to close as early as September 1, 2025. The cash consideration will be funded by a combination of the Company’s existing cash on hand and a $150 million Convertible Notes Offering
Evercore Inc. acted as financial advisor for Melinta Therapeutics, LLC. Fenwick & West LLP acted as legal advisor for Melinta Therapeutics, LLC. Katten Muchin Rosenman LLP acted as legal advisor for Deerfield Management Company, L.P. Jared Fertman and Andrew Marmer of Willkie Farr & Gallagher LLP acted as legal advisor to CorMedix Inc. Annonce • Aug 07
CorMedix Inc. Provides Earnings Guidance for the Full Year 2025 CorMedix Inc. provided earnings guidance for the full year 2025. For the year, the company expects Pro Forma 2025 Revenue: $305 million – $335 million. Annonce • Jun 27
CorMedix Inc. has completed a Follow-on Equity Offering in the amount of $85 million. CorMedix Inc. has completed a Follow-on Equity Offering in the amount of $85 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,604,507
Price\Range: $12.869999 Annonce • Jun 27
CorMedix Inc. has filed a Follow-on Equity Offering in the amount of $85 million. CorMedix Inc. has filed a Follow-on Equity Offering in the amount of $85 million.
Security Name: Common Stock
Security Type: Common Stock Annonce • Jun 24
CorMedix Inc. Increases Net Sales Guidance of Second Quarter 2025 CorMedix Inc. announced that as a result of this new customer implementation and other positive business developments, CorMedix is increasing its second quarter 2025 net sales guidance from the previously communicated $31 million to a range of $35 million to $40 million. Annonce • May 06
CorMedix Inc. Revises Sales Guidance for the First Half of 2025 CorMedix Inc. revised sales guidance for the first half of 2025. The company expected to be at the high-end of the previously announced first half net sales guidance of $62 million to $70 million, based on latest order trends and inventory tracking with current purchasing customers. Annonce • Apr 29
CorMedix Inc., Annual General Meeting, Jun 24, 2025 CorMedix Inc., Annual General Meeting, Jun 24, 2025. Annonce • Apr 08
CorMedix Inc. Raises Financial Guidance for First Half of 2025 CorMedix Inc. raised financial guidance for first half of 2025. Since providing initial guidance, the Company received larger than expected orders during the final week of March, and has also obtained additional visibility into inventory levels on hand at some of its current purchasing customers. Based on this new information, CorMedix is increasing its first half 2025 guidance for Net Sales to existing purchasing customers to a revised range of $62 million to $70 million. Annonce • Mar 25
CorMedix Inc. Provides Preliminary Earnings Guidance for the First Half of 2025 CorMedix Inc. provides preliminary earnings guidance for the first half of 2025. For the year, the company expects net revenue guidance for first half of 2025 of $50– $60 million, based on the run rate of current purchasing customers, with more than $33 million expected in first quarter. Annonce • Mar 18
CorMedix Inc. to Report Q4, 2024 Results on Mar 25, 2025 CorMedix Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 25, 2025 Annonce • Oct 23
CorMedix Inc. to Report Q3, 2024 Results on Oct 30, 2024 CorMedix Inc. announced that they will report Q3, 2024 results on Oct 30, 2024 Annonce • Oct 09
CorMedix Inc., Annual General Meeting, Nov 21, 2024 CorMedix Inc., Annual General Meeting, Nov 21, 2024. Annonce • Aug 07
CorMedix Inc. to Report Q2, 2024 Results on Aug 14, 2024 CorMedix Inc. announced that they will report Q2, 2024 results Pre-Market on Aug 14, 2024 Annonce • May 11
CorMedix Inc. has filed a Follow-on Equity Offering in the amount of $50 million. CorMedix Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annonce • May 08
CorMedix Inc. to Report Q1, 2024 Results on May 09, 2024 CorMedix Inc. announced that they will report Q1, 2024 results Pre-Market on May 09, 2024 Annonce • Apr 15
CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath®? (Taurolidine and Heparin) CorMedix Inc. 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 infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (HD-CVC). The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024. Outpatient commercial availability is contingent upon the Center for Medicare & Medicaid Services (CMS) approval and implementation of the DefenCath Transitional Drug Add-On Payment Adjustment (TDAPA) application in accordance with the agency's publicly stated objective that CMS aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS code for the product. The CMS Final HCPCS coding decision for DefenCath was published by CMS on April 2nd, establishing a new HCPCS Level II code for DefenCath, and CorMedix continues to work closely with CMS on the TDAPA implementation process. New Risk • Apr 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (24% increase in shares outstanding). Recent Insider Transactions • Mar 15
CEO & Director recently bought US$51k worth of stock On the 13th of March, Joseph Todisco bought around 14k shares on-market at roughly US$3.74 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Joseph has been a buyer over the last 12 months, purchasing a net total of US$111k worth in shares. Breakeven Date Change • Mar 13
Forecast breakeven date moved forward to 2025 The 4 analysts covering CorMedix previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 2.8% to 2024. The company is expected to make a profit of US$6.71m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Annonce • Mar 07
CorMedix Inc. to Report Q4, 2023 Results on Mar 12, 2024 CorMedix Inc. announced that they will report Q4, 2023 results Pre-Market on Mar 12, 2024 Price Target Changed • Feb 01
Price target decreased by 7.0% to US$13.25 Down from US$14.25, the current price target is an average from 4 analysts. New target price is 349% above last closing price of US$2.95. Stock is down 34% over the past year. The company is forecast to post a net loss per share of US$0.85 next year compared to a net loss per share of US$0.74 last year. Annonce • Jan 31
CorMedix Inc. Updates Related to Its Business and Anticipated Launch of DefenCath CorMedix Inc. announced updates related to its business and anticipated launch of DefenCath. On January 25, 2024 the Center for Medicare & Medicaid Services (CMS) notified CorMedix that the agency has determined DefenCath will be eligible for reimbursement in accordance with the ESRD PPS. As such, CorMedix is entitled to submit an application for a Transitional Drug Add-On Payment (TDAPA) which currently allows for five years of additional payment reimbursement to outpatient providers. CorMedix submitted its TDAPA application on January 26 after receiving the CMS notification, and CMS has subsequently confirmed receipt. As a result of CMS' determination that DefenCath is within the scope of the ESRD PPS and eligible for TDAPA, CorMedix has established its list price (WAC) of $249.99 per 3ml vial, to account for the market dynamics and functionality of the TDAPA framework. Should CMS make a future determination that DefenCath is eligible for Medicare Part B reimbursement, CorMedix has committed to CMS to reduce the list price accordingly. CorMedix previously applied for and received a New Technology Add-On Payment (NTAP) from CMS for inpatient reimbursement of DefenCath. Now that the company has established a WAC price for commercialization, CorMedix will notify CMS accordingly to make any necessary adjustment to the NTAP reimbursement payment to inpatient facilities. Annonce • Jan 08
Cormedix Inc. Announces Commercial and Operational Updates CorMedix Inc. announced several commercial and operational updates related to its business and anticipated launch of DefenCath®. Recent Updates: CorMedix formally submitted an HCPCS application for a J-Code to the Center for Medicare and Medicaid Services (CMS) on December 8, 2023 for DefenCath, and CMS has confirmed the application is under review. The Company continues to engage in discussions with CMS related to the appropriate outpatient reimbursement structure for DefenCath and remains committed to its pursuit of separate payment under Medicare Part B as the appropriate reimbursement mechanism for the product. In such an instance, the Company expects to establish a list price based on the market dynamics for both inpatient contracting as well as a Transitional Drug Add-On Payment (TDAPA) framework for outpatient reimbursement. CorMedix would then subsequently revise the list price downward should CMS make a determination in favor of separate payment under Medicare PartB. CorMedix expects to provide further detail on the DefenCath market opportunity as the company receive clarity from CMS regarding outpatient reimbursement. The Company believes it has sufficient cash, cash equivalents and available resources to fund the commercial launch. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 4 analysts covering CorMedix expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$16.6m in 2026. Average annual earnings growth of 59% is required to achieve expected profit on schedule. Annonce • Dec 16
CorMedix Inc. Approves the Separation of Employment of Phoebe Mounts On December 12, 2023, upon mutual agreement between CorMedix Inc. (the “Company”) and Phoebe Mounts, Ph.D., Esq., the Company’s Executive Vice President, General Counsel and Corporate Secretary, the Board of Directors of the Company (the “Board”) approved the separation of employment of Dr. Mounts, effective December 31, 2023 (the “Termination Date”). Dr. Mounts will cease to hold the title of General Counsel and Corporate Secretary effective December 12, 2023. Until the Termination Date, Dr. Mounts will continue to serve as Executive Vice President and devote her time and attention to facilitating the transition of her duties and responsibilities. Annonce • Dec 15
CorMedix Inc. Announces the Appointment of Beth Zelnick Kaufman, Esq. as Executive Vice President, Chief Legal Officer, and Corporate Secretary, Effective December 12, 2023 CorMedix Inc. 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. Ms. Zelnick Kaufman has more than two decades of legal, compliance and operations experience in the life sciences industry. Prior to joining CorMedix, she most recently served as Chief Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals, a specialty and generic pharmaceuticals company. Ms. Zelnick Kaufman also served in several roles at Amneal Pharmaceuticals, a publicly traded global generics, biosimilars and branded pharmaceuticals company, including roles as Assistant General Counsel, Vice President, Legal Affairs, and Head of Government Affairs. During her tenure at these and other pharmaceutical companies, Ms. Zelnick Kaufman gained deep experience in the pharmaceutical industry across legal, regulatory, government affairs, and other operational areas. Earlier in her career, Ms. Zelnick Kaufman held roles at Actavis, Alpharma and Topcon America and spent time as an Associate in the law firm Brown, Rudnick. Ms. Zelnick Kaufman holds a Juris Doctor degree from New York University Law School and a Bachelor of Arts degree from Amherst College. Annonce • Nov 17
CorMedix Inc. Announces FDA Approval of DefenCath(R) to Reduce the Incidence of Catheter Related Bloodstream Infections in Adult Hemodialysis Patients CorMedix Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath(R) (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). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study. The FDA approval of DefenCath was supported by results from the randomized, double-blind, active control, multicenter pivotal Phase 3 LOCK-IT-100 clinical trial designed to assess the efficacy and safety of DefenCath for reducing the incidence of CRBSIs in patients with kidney failure receiving chronic Hemodialysis through a central Venous catheter. The FDA approval of DefENCath was supported by results from The randomized, double-blind, Active control, multicenter pivotal Phase3 LOCK-IT-100clinical trial designed to assess the efficacy, safety of DefenCath for reduce the incidence of CRBSIs In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS. Until now, patients who need hemodialysis via a central venous catheter have had little choice other than to accept high infection risks associated with the existing standard of care. The FDA's approval of DefenCath is a meaningful moment for patients and their healthcare providers because they now have a new alternative to reduce the risks of CRBSIs. DefenCath is an antimicrobial catheter lock solution (CL S) approved by the FDA to reduce the incidence of cat catheter-related bloodstream infections ("CRBSIs") for the limited population of adult patient with kidney failure receiving chronic he modialysis through a central venal catheter (CVC). In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious or life-threatening infections. DefenCath has been designated by FDA as Fast-up, and FDA as Fast-up, a novel, non-antibiotic antimicrobial antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been identified by FDA as Fast-up and FDA as Fast-up and a Phase 3 clinical study. Reported Earnings • Nov 16
Third quarter 2023 earnings released: US$0.17 loss per share (vs US$0.17 loss in 3Q 2022) Third quarter 2023 results: US$0.17 loss per share (further deteriorated from US$0.17 loss in 3Q 2022). Net loss: US$9.74m (loss widened 42% from 3Q 2022). Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 20% per year, which means it is performing significantly worse than earnings. Annonce • Nov 03
CorMedix Inc. to Report Q3, 2023 Results on Nov 14, 2023 CorMedix Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023 Annonce • Sep 14
CorMedix Inc., Annual General Meeting, Oct 26, 2023 CorMedix Inc., Annual General Meeting, Oct 26, 2023, at 09:00 US Eastern Standard Time. Agenda: To elect seven directors to serve until the 2024 Annual Meeting of Stockholders and until their successors are duly elected and qualified; to approve on a non-binding advisory basis the compensation of company's named executive officers for 2022; to ratify the appointment of Marcum LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to act upon such other matters as may properly come before the meeting or any adjournment, postponement or continuation thereof. Annonce • Aug 18
Cormedix Inc. Announces Resignation of Paulo F. Costa as Member of the Board of Directors, Effective as of October 15, 2023 CorMedix Inc. announced that Paulo F. Costa, a member of the Board of Directors notified the Board that he will be retiring from the Board, effective as of October 15, 2023. The Company does not intend to fill Mr. Costa’s seat on the Board at this time and therefore the size of the Board will be reduced to seven directors effective as of October 15, 2023. The Company expressed gratitude to Mr. Costa for his contributions to the Board and the Company. Mr. Costa’s departure is not as a result of any dispute or disagreement with the Company, its management, the Board, or any matter relating to the Company’s operations, policies or practices. The Board is evaluating how it intends to fill Mr. Costa’s committee assignment. Price Target Changed • Aug 11
Price target decreased by 18% to US$13.75 Down from US$16.67, the current price target is an average from 4 analysts. New target price is 212% above last closing price of US$4.40. Stock is up 6.0% over the past year. The company is forecast to post a net loss per share of US$1.02 next year compared to a net loss per share of US$0.74 last year. Reported Earnings • Aug 08
First half 2023 earnings released: US$0.49 loss per share (vs US$0.38 loss in 1H 2022) First half 2023 results: US$0.49 loss per share (further deteriorated from US$0.38 loss in 1H 2022). Net loss: US$21.8m (loss widened 49% from 1H 2022). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 7.1% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Annonce • Jul 28
CorMedix Inc. to Report Q2, 2023 Results on Aug 08, 2023 CorMedix Inc. announced that they will report Q2, 2023 results Pre-Market on Aug 08, 2023 Annonce • Jun 22
CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath CorMedix Inc. announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023. DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter. Annonce • May 17
Cormedix Inc. Announces Resubmission of New Drug Application for Defencath CorMedix Inc. 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. Reported Earnings • May 17
First quarter 2023 earnings released: US$0.24 loss per share (vs US$0.18 loss in 1Q 2022) First quarter 2023 results: US$0.24 loss per share (further deteriorated from US$0.18 loss in 1Q 2022). Net loss: US$10.6m (loss widened 50% from 1Q 2022). Revenue is forecast to grow 199% p.a. on average during the next 2 years, compared to a 7.1% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Annonce • May 09
CorMedix Inc. to Report Q1, 2023 Results on May 15, 2023 CorMedix Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 15, 2023 Reported Earnings • Mar 31
Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2022 results: US$0.74 loss per share. Net loss: US$29.7m (loss widened 5.3% from FY 2021). Revenue exceeded analyst estimates. Earnings per share (EPS) missed analyst estimates by 1.4%. Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 5.1% growth forecast for the Pharmaceuticals industry in the US. Annonce • Jan 18
Cormedix Inc. Announces Promotions in Commercial and Tech Ops CorMedix Inc. announced the following promotions within the organization: Erin Miststry, SVP Commercial, has been promoted to EVP and Chief Commercial Officer. Ms. Mistry will have oversight and responsibility for all commercial launch strategy for DefenCath and the build out of launch infrastructure, including but not limited to market access, commercial operations and field-based sales personnel. Ms. Mistry joined CorMedix 2020 and has been an integral architect of the company's go to market and reimbursement strategy. Dr. Tushar Mukherjee, VP of Technical Operations has been promoted to SVP, Head of Technical Operations. Dr. Mukherjee joined CorMedix in early 2022 and has been a valuable leader and contributor for the technical team. In his new role, Dr. Mukherjee will report directly to the CEO and will assume responsibility for the final validation of all manufacturing, packaging and analytical testing of DefenCath, as well as all technical reviews of new product opportunities. Dr. Phoebe Mounts who had previously assumed interim oversight of technical operations will remain with the organization in her critical role as General Counsel and Head of Regulatory Affairs. Recent Insider Transactions • Nov 18
CEO & Director recently bought US$76k worth of stock On the 15th of November, Joseph Todisco bought around 20k shares on-market at roughly US$3.82 per share. This transaction increased Joseph's direct individual holding by 1x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Joseph has been a buyer over the last 12 months, purchasing a net total of US$129k worth in shares. Price Target Changed • Nov 16
Price target increased to US$15.00 Up from US$14.00, the current price target is an average from 3 analysts. New target price is 307% above last closing price of US$3.69. Stock is down 29% over the past year. The company is forecast to post a net loss per share of US$0.73 next year compared to a net loss per share of US$0.75 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 5 experienced directors. No highly experienced directors. Independent Director Janet Dillione is the most experienced director on the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.