Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (June 2023)
22 slides from Cormedix's investor presentation, June 2023
Slide 1: Corporate Presentation
Corporate Presentation June 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: Who is CorMedix?
Who is CorMedix? • CorMedix is a publicly listed (Nasdaq: CRMD), small cap pre-commercial stage biopharma company developing therapeutic products for the prevention and treatment of life-threatening conditions and diseases • Our lead asset is DefenCath, a novel, first-in-class, non-antibiotic antimi
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: CRBSI are a Common and Life-threatening Complication of CVC use
Catheter Related Bloodstream Infections (CRBSI) are a Common and Life-threatening Complication of CVC use Disease Burden Health Economics ~80% of patients starting HD (hemodialysis) will have a CVC HD patients with CRBSIs have almost 2x more inserted for vascular access 1 hospitalizations per year 4
Slide 7: 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 8: 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 9: 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 10: 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 11: 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) 11
Slide 12: Targeting Multiple Potential Large Therapeutics Areas
Targeting Multiple Potential Large Therapeutics Areas • DefenCath is a novel, first in class, non-antibiotic catheter lock solution, designed to reduce CRBSIs and maintain catheter patency in patients with CVCs • Our proprietary NCE Taurolidine demonstrates broad spectrum, antimicrobial activity aga
Slide 13: 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 14: 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* 3ml vials per exceed a DRG payment amount by at least one standard deviation
Slide 15: 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 16: 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 17: Health System Strategic Partnerships
Health System Strategic Partnerships • BMC Partnership is a blueprint for other health systems from which we have a legitimate clinical or business need for data • Pre-approval disease awareness Inpatient Formulary • DefenCath education and system implementation • Demonstration of value across care
Slide 18: 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 19: DefenCath Regulatory & Manufacturing Background
DefenCath Regulatory & Manufacturing Background • CorMedix announced the completion of the DefenCath submission in July 2020, announced receipt of a complete response letter (CRL) in March of 2021. The NDA was subsequently resubmitted to FDA in February of 2022 and received a second CRL in August of
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*** ~$250 million * Excluding restricted cash ** as of 3/31/2023 *** as of 6/20/2023 20
Slide 21: CorMedix’s Key Investment Highlights
CorMedix’s Key Investment Highlights 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 the risk and incidence of First in Class
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 Taurolidine-Based Cathet