Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (August 2024)
32 slides from Cormedix's investor presentation, Aug 14, 2024
Slide 1: Corporate Presentation
Corporate Presentation August 2024 Version: 8/14/2024
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: Who is CorMedix?
Who is CorMedix? • CorMedix is a publicly listed (Nasdaq: CRMD), small cap early commercial stage biopharma company developing therapeutic products for the prevention and treatment of life-threatening conditions and diseases • Approved in November 2023, our lead asset DefenCath® is a novel, first-in
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 • Interim CEO of CorMedix
Slide 5: The Problem: CRBSI
The Problem: CRBSI Catheter Related Bloodstream Infections 5
Slide 6: Most Replacement Kidney Function Patients Use Hemodialysis, Initially Via CVC
The Majority of Patients who Need Replacement Kidney Function use Hemodialysis, and are Initially Treated through a CVC • ESRD – The advanced state of • ~60 – 70% of patients with ESRD or • CVC can be used immediately and is widely chosen at initiation chronic kidney disease in which AKI are treated
Slide 7: CVCs are Responsible for ~70% of Access-related Bloodstream Infections
CVCs are Responsible for ~70% of Access-related Bloodstream Infections in Hemodialysis Patients Dialysis Patients by Access-Related Bloodstream Access Type Infection by Access Type CRBSIs can occur in 25-33% of CVC 100% 100% HD patients, and are caused by a wide range of pathogens-many of which ar
Slide 8: CRBSIs Result in Significant Patient Morbidity, Mortality and Cost
CRBSIs Result in Significant Patient Morbidity, Mortality and Cost to the Healthcare Systems Kaplan Meier Survival Estimate, Time to Death 40-50% of dialysis patients are considered high risk for infections No CRBSI CRBSI 1.0 Mortality occurs rapidly Infections are the second most common in patients
Slide 9: Need for Improved Protection Against CRBSI Risk Spans Care Settings
The Need for Improved Protection Against Risk of CRBSIs Spans the Care Settings Where Patients Receive Hemodialysis Outpatient Setting Inpatient Setting • Outpatient dialysis providers face • Preventing CRBSIs in the inpatient setting is top- significant financial and reputational of-mind for hospit
Slide 10: Introducing: DefenCath
Introducing: DefenCath 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 veno
Slide 11: DefenCath is a First and Only FDA Approved Catheter Lock Solution
DefenCath is a First and Only FDA Approved Catheter Lock Solution with Significant Risk Reduction in CRBSIs • First and only FDA-approved antimicrobial catheter lock solution • Broad antimicrobial activity against common Gram-positive and Gram- negative bacteria, multi-drug resistant bacteria, and c
Slide 12: DefenCath Reduced CRBSI Risk in Phase 3 LOCK-IT-100 Study
DefenCath Demonstrated Significant Reduction in CRBSI Risk in the Phase 3 LOCK-IT-100 Study Full Study Total CRBSIs (D / H) 41 (9 D / 32 H) Total Subjects 795 Reduction in Risk of CRBSIs 71% p-value 0.0001 -71% Overall, fewer patients had catheters 0.6 removed due to CRBSIs with DefenCath 0.5 compar
Slide 13: Safety Profile and Usage Logistics Support Widespread Adoption
Safety Profile and Usage Logistics Support Widespread Adoption Safety • Safety profile comparable to heparin CLS control (current SoC) • Similar catheter patency and catheter removal frequency to heparin control arm • No demonstrated antimicrobial resistance Logistics • Stored at room temperature •
Slide 14: The Opportunity
The Opportunity DefenCath® has a clear and compelling value proposition across both inpatient and outpatient dialysis channels to help reduce infection risk, provide savings / reduce missed revenue, and reduced patient mortality 14
Slide 15: DefenCath Positioned to Capture Value Across Outpatient and Inpatient Markets
DefenCath is Well Positioned to Capture Significant Value Across both Outpatient and Inpatient Markets Outpatient Dialysis Organizations Inpatient Hospitals Potential: ~37MM vials for ESRD patients Potential: ~3.8MM vials for ESRD and (Total annual addressable market) AKI Patients (Total annual addr
Slide 16: Outpatient Value Proposition
Outpatient Value Proposition Reduce Missed Dialysis Sessions Retain QIP Quality Metrics Reduce CRBSI Mortality • Dialysis organizations estimated to • In order to avoid up to a 2% • To retain patients, dialysis lose ~$570MM annually due to reduction in reimbursement organizations will seek to missed
Slide 17: Outpatient Opportunity Targeting ~170k Hemodialysis Patients
Outpatient Opportunity Targeting ~170k Hemodialysis Patients Representing ~37mm+ of Potential Units Total Addressable Outpatient Population 2024E Yearly HD Sessions 600 with CVC 20 Total, 487 Chronic HD = 156 ~37 – 46MM Sessions (MM) 15 Number of HD Patients (000s) 400 HD New New HD = 108 Starts, 12
Slide 18: DefenCath Reimbursed by CMS Under TDAPA
DefenCath Reimbursed by CMS Under TDAPA, Add-on Payment Outside of ESRD Fee-for-Service Bundle, Incentivizing Adoption Transitional Drug Add-on Payment Adjustment (TDAPA) New injectables or IV drugs whose Provides additional reimbursement Between years 3-5, add-on Financial incentive to pilo
Slide 19: Inpatient Value Proposition
Inpatient Value Proposition Significant Lack of Hospital Cost Infection Antimicrobial Savings Reduction Resistance • Infection reduction can directly • Antimicrobial stewardship is top • By reducing infections, DefenCath reduce: of mind for most hospitals, who may reduce additional costs – Patient l
Slide 20: Inpatient ESRD Opportunity Targeting ~220k ESRD Hospital Stays
Inpatient ESRD Opportunity Targeting ~220k ESRD Hospital Stays Representing ~1.1mm in Potential Units Total Addressable ESRD Hospitalizations 2024E DefenCath ~20% of chronic patients Addressable and new start patients 600 Hospital 600 for ~5.5 months Stays Total, 487 ~1.1MM ESRD Outpatients (000s) H
Slide 21: Inpatient AKI Opportunity Targeting ~170k Hospitalizations
Inpatient ESRD Opportunity Targeting ~170k AKI Hospitalizations Representing ~2.7mm in Potential Units Total Addressable AKI Hospitalizations 2024E DefenCath Addressable 5,000 ~5% require Hospital Stays 5,000 HD 4,000 ~70% receive ~2.7MM intermittent, 300 30% Hospitalizations (000s) continuous 5,000
Slide 22: DefenCath Granted NTAP by CMS
DefenCath has Been Granted NTAP by CMS Through Demonstrating Substantial Improvement over Existing Solutions DefenCath’s Path to NTAP Payment to Hospital during NTAP Period Normal reimbursement from DRG Met qualifying criteria including substantial clinical improvement over existing services* NTAP r
Slide 23: Commercial Execution & Strategy
Commercial Execution & Strategy DefenCath launched in the inpatient setting April 15 and in the outpatient setting July 1 • Based on concentrated markets and focus on key decision makers, modest infrastructure required for launch • CorMedix field sales team consists of ~30 highly experienced profess
Slide 24: Expansion
Expansion Taurolidine and Heparin Catheter Lock Solution has potential to show efficacy in the preventing of deadly blood stream infections in other patient populations 24
Slide 25: CorMedix Plans to Pursue Additional Indications for Taurolidine/Heparin
CorMedix Plans to Pursue Additional Indications for Taurolidine/Heparin Combination • CorMedix aims to pursue other potential indications for Taurolidine/Heparin including Pediatric HD (requirement under PREA), Total Parenteral Nutrition (TPN), and Oncology • Received Type C feedback from FDA in Jun
Slide 26: Total Parenteral Nutrition is a Critical Treatment
Total Parenteral Nutrition is a Critical Treatment for Sustaining Nutrition in Patients with Various Serious Conditions Total parenteral nutrition (TPN) is a method of feeding in which fluids are given through a vein to provide most of the Total Parenteral Nutrition Protocols nutrients the body need
Slide 27: Infections are a Major Concern in TPN
Infections are a Major Concern in TPN, Due to the Unique Combination of Factors that Make these Patients More Likely to Get Infected Parenteral Nutrition 1-4 episodes of Drivers of Infections infection per 1,000 catheter days • Components of TPN: Sugars and lipids support growth of bacteria and fung
Slide 28: Infections in TPN Patients Increase Risk of Mortality
Infections in TPN Patients Increase the Risk of Mortality and Other Negative Outcomes • CLABSIs are associated with an increased mortality rate of 12-25% • In addition to death, CLABSIs in TPN patients can lead to septic shock, organ damage or failure, or blood clotting CLABSIs are associated with a
Slide 29: TPN Represents a DefenCath Opportunity of ~4.7MM Infusions per Year
Across Outpatient and Inpatient Settings, TPN Represents a DefenCath Opportunity of ~4.7MM Infusions per Year US Total Parenteral Nutrition Total Addressable Market 2024E 4.0 Ports or IVs 3.6 3.5 CVCs, PICCs, or Midlines 0.5 Total Infusions (MM) 3.0 DefenCath Addressable Infusions 2.5 2.0 1.8 ~4.7MM
Slide 30: Financial Metrics
Financial Metrics ¥ CorMedix
Slide 31: Financial Highlights
Financial Highlights Key Statistics Balance Sheet Exchange NASDAQ Global Market Cash and short-term investments* $45.6 million** Common Stock 55.9 million shares as of 8/12/2024 Debt None Market cap*** ~$250 million * Excluding restricted cash ** as of 6/30/2024 *** as of 8/1/2024 Note: DefenCath, C
Slide 32: 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 Taurolidine-Based Cathet