Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (May 2023)
22 slides from Cormedix's investor presentation, May 2023
Slide 1: Corporate Presentation
Corporate Presentation May 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject t
Slide 3: CorMedix's Lead Product DefenCath Targets Substantial Market Opportunities
CorMedix’s Lead Product DefenCathTM Targets Substantial Market Opportunities DefenCath is a novel, broad-spectrum, antimicrobial catheter lock solution with the potential to change the standard of care in several large markets – there is no current pharmacologic agent approved to prevent or reduce t
Slide 4: CorMedix Executive Leadership Team
CorMedix Executive Leadership Team JO INED CO RM EDIX PRIO R EXPERIEN CE • Chief Commercial Officer of Amneal Specialty Joe Todisco 2022 • Co-founder and Chief Executive of Gemini Laboratories Chief Executive Officer • Commercial Strategy and business development at Ranbaxy • Head of Strategy at Ovi
Slide 5: The Problem: CRBSI
The Problem: CRBSI Catheter Related Bloodstream Infections 5
Slide 6: Key Takeaways from Inpatient HECON Analysis
Key Takeaways from Inpatient HECON Analysis 9% 92% 60% 3x to 13% to 99% to 72% to 5x Observed incidence All-cause readmission 30-day readmission Greater 30-day readmission of CRBSI for inpatients rate among CRBSI rate for CRBSI rates for CRBSI vs non- with the diagnosis of AKI, patients, ~80% within
Slide 7: CRBSIs Can Increase Hospitalizations, Length of Stay and Negatively Impact Concomitant Conditions
CRBSIs Can Increase Hospitalizations, Length of Stay and Negatively Impact Concomitant Conditions Increases in Hospitalizations and LOS with CRBSIs Increases in Major Complications with CRBSIs CRBSIs resulted in higher 1-year incremental rates of3,†: CRBSI Non CRBSI P-value Dysrhythmia 26.7% Mean Nu
Slide 8: CRBSIs Significantly Increase the Risk of Death
CRBSIs Significantly Increase the Risk of Death • In an analysis of 55,727 CVC-dependent HD patients, mortality rates at 3 months for HD-CVC patients with CRBSI was 3x higher than those without Kaplan Meier Survival Estimate, Time to Death Mortality Rates for CRBSI vs Non-CRBSI Patients No CRBSI CRB
Slide 9: CDC Reported Infection Rates and Health Equity Implications: CMS Proposed Policy Improvements
CDC Reported Infection Rates and Health Equity Implications: CMS Proposed Policy Improvements for Infection Prevention Race, Ethnicity, and Socioeconomic Factors Affect BSI Rates CMS Proposes Policies to Improve Patient S. aureus BSI Rates by Race/Ethnicity* Safety and Promote Health Equity Rate per
Slide 10: Our Proposed Solution: DefenCath
Our Proposed Solution: DefenCath™ A novel, first-in-class, antimicrobial catheter lock solution, with broad- spectrum antibacterial and antifungal activity, designed to reduce CRBSIs and maintain catheter patency in patients with central venous catheters (CVCs) 10
Slide 11: Targeting Multiple Potential Large Therapeutics Areas
Targeting Multiple Potential Large Therapeutics Areas • DefenCath is an antimicrobial catheter lock solution, non-antibiotic, designed to reduce CRBSIs and maintain catheter patency in patients with CVCs • Broad spectrum, antimicrobial activity against gram-negative and gram-positive bacteria, multi
Slide 12: Phase 3 LOCK-IT-100 – Compelling Clinical Profile
Phase 3 LOCK-IT-100 – Compelling Clinical Profile3 Objective: to demonstrate the efficacy and safety of DefenCath Interim Analysis Full Study as a catheter lock solution for the prevention of CRBSI and the Total CRBSIs (D / H) 28 (6 D / 22 H) 41 (9 D / 32 H) incidence of treatment-emergent adverse e
Slide 13: Large Addressable Market Opportunity in Hemodialysis
Large Addressable Market Opportunity in Hemodialysis (Inpatient + Outpatient) Setting Of Care Addressable Market Reimbursement Dynamics NTAP (New Technology Add-On Payment) is an additional payment for drugs that • 3mm-5mm* lumen locks exceed a DRG payment amount by at least one standard deviation p
Slide 14: Key Customers Types and Settings of Care
Key Customers Types and Settings of Care Market channel segmentation and channel specific commercial strategy will be essential to a successful commercialization of DefenCath Inpatient Outpatient Large National Large Regional Large Dialysis Health Systems Hospital Networks Organizations (LDOs) Gover
Slide 15: Settings of Care: Payment and Reimbursement Simplified
Settings of Care: Payment and Reimbursement Simplified Inpatient Outpatient • DRG: a determined amount of money is paid to • Bundle: Each hemodialysis session is reimbursed the hospital for conditions or admissions to the dialysis center at a set fixed amount (“the bundle”) to cover all expenditures
Slide 16: Commercial Execution & Strategy
Commercial Execution & Strategy CorMedix intends to launch first in the inpatient setting, while working simultaneously to obtain outpatient reimbursement clarity. Modest infrastructure required for both settings of care. Hospital (Inpatient) Dialysis Facility (Outpatient) A commercial organization
Slide 17: NTAP Designation Provides Additional Reimbursement Possibility at Launch to Hospitals
NTAP Designation Provides Additional Reimbursement Possibility at Launch to Hospitals New Technology Add-on Payment (NTAP) designation enables additional payment to hospitals above the standard Diagnosis-Related Group (DRG) payment amount for Medicare patients How a hospital typically gets paid How
Slide 18: Inpatient: Understanding Pharmacy & Therapeutics Committees (P&T)
Inpatient: Understanding Pharmacy & Therapeutics Committees (P&T) P&T Committees are an established group within the hospital, in charge of the development and maintenance of the formulary, an evolving list of drug products available to the medical staff. High-Level P&T Process Flow 1 2 3 A New Prod
Slide 19: DefenCath Manufacturing & Supply Chain Strategy
DefenCath Manufacturing & Supply Chain Strategy • The Company completed a Type A meeting in April with FDA to discuss guidance with respect to the DefenCath NDA re-submission: • FDA informed CorMedix that it is in receipt of the close out report for inspectional observations received from its existi
Slide 20: Financial Highlights
Financial Highlights Key Statistics Balance Sheet Exchange NASDAQ Global Market Cash and short-term investments* $55.6 million** Common Stock 45.4 million shares as of 5/10/2023 Debt None Market cap ~$230 million * Excluding restricted cash ** as of 3/31/2023 20
Slide 21: CorMedix Key Investment Highlights
CorMedix Key Investment Highlights DefenCath is a novel product • First in class therapy addressing critical unmet medical need addressing a significant unmet • $2.3 billion spent annually on CRBSI medical need Compelling Efficacy and • 71% reduction in risk of CRBSI Safety Profile • Highly statisti
Slide 22: References
References 1. USRDS End Stage Renal Disease 2020 Annual Data Report; Chapter 3; Vascular Access 2. Araya S. et.al.; Racial and Sex Disparities in Catheter Use and Dialysis Access in the United States Medicare Population JASN 31: 625–636, 2020 3. LOCK-IT-100: CRMD003, A Novel Tauroline-Based Catheter