Slide 1: DefenCath: A potentially new standard-of-care in prevention of CRBSIs
DefenCathTM: A potentially new standard-of-care in the prevention of catheter related blood stream infections CORMEDIX
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Th
Slide 3: DefenCath is a Novel Product Targeting Substantial Market Opportunities
DefenCathTM is a Novel Product Targeting Substantial Market Opportunities • DefenCath is a novel catheter lock solution with the potential to change the standard of care in several large markets – no current Novel Product Addressing a pharmacologic agent approved to prevent infections associated wit
Slide 4: CorMedix Senior Management Team
CorMedix Senior Management Team Khoso Baluch Chief Executive Officer Matt David, MD EVP and Chief Financial Officer Phoebe Mounts, PhD, JD EVP and General Counsel Paul Chew, MD Chief Medical Officer Jack Armstrong EVP Technical Operations EVP & Head of Clinical Elizabeth Masson Hurlburt Operations C
Slide 5: Targeting a Substantial Commercial Market Opportunity
Targeting a Substantial Commercial Market Opportunity • No pharmacologic agents approved in the U.S. for the prevention of CRBSI in central venous catheters • Total annual cost in U.S. for treating all CRBSI and their complications up to $2.7B • Multiple organizations are focused on reducing CRBSIs
Slide 6: DefenCath/Neutrolin is an Anti-Bacterial and Anti-Fungal Catheter Lock Solution
DefenCathTM/Neutrolin® is an Anti-Bacterial and Anti-Fungal Catheter Lock Solution Designed to Prevent CRBSIs and Clotting • Used to fill catheter lumens when they are not in use to prevent microbial growth and clotting DEFENCATH / NEUTROLIN PROPRIETARY FORMULATION NEUTROLIN/DEFENCATH REGULATORY STA
Slide 7: LOCK-IT-100 – Pivotal Clinical Trial Design
LOCK-IT-100 – Pivotal Clinical Trial Design • Phase 3, multicenter, double-blind, randomized (1:1), active control (heparin) • Event-driven: 56 CRBSI events required to complete the study; 28 CRBSI events at Interim Analysis met pre-specified DESIGN efficacy endpoint without safety concerns and Data
Slide 8: Phase 3 LOCK-IT-100 – Topline Results
Phase 3 LOCK-IT-100 – Topline Results Primary endpoint met – highly statistically significant efficacy Secondary safety endpoints met - no statistically significant differences between DefenCath (D) & Heparin (H) control arm for loss of catheter patency and catheter removal Interim Analysis Full
Slide 9: Phase 3 LOCK-IT-100 – Conclusions
Phase 3 LOCK-IT-100 – Conclusions LOCK-IT-100, a landmark study, showed that in ESRD subjects with hemodialysis via a 01 central venous catheter, DefenCath catheter lock solution significantly reduced catheter- related bloodstream infections by 71% (p=0.0006) in 795 patients (9 D, 32 H). Compared to
Slide 10: DefenCath Regulatory Status
DefenCath Regulatory Status • DefenCath NDA was filed and supported by data from LOCK-IT-100 as substantial evidence of safety and effectiveness • Priority review of the NDA was granted; goal of 6 months vs. standard review period of 10 months • February 28, 2021 PDUFA • Also requested NDA approval
Slide 11: Marketing Exclusivity and Intellectual Property
Marketing Exclusivity and Intellectual Property MARKET EXCLUSIVITY • Upon approval, 10.5 years of potential market exclusivity • Designated an Investigational New Drug by FDA • New Chemical Entity (NCE) Status – 5 years of exclusivity • Designated as Qualified Infectious Disease Product (QIDP) – add
Slide 12: DefenCath Pricing Will be Supported by its Clinical and Economic Benefits
DefenCath Pricing Will be Supported by its Clinical Benefit and Economic Benefits to the Healthcare System Several factors currently being assessed to derive pricing include: 1 In the US, will be the first approved antimicrobial catheter lock solution 2 Facilities and patients involved in at-risk ar
Slide 13: Medicare (CMS) Accounts for ~90% of ESRD Reimbursement
Medicare (CMS) Accounts for ~90% of ESRD Reimbursement and is Very Focused on Quality of Care ESRD PPS has quality measures as part of its Payer Mix for Dialysis Coverage reimbursement More Choice Patients methodology 19% Medicare coverage kicks in Quality of Care Measures Medicare Advantage ~1% • E
Slide 14: DefenCath Reimbursement Opportunity Through TDAPA
DefenCath Reimbursement Opportunity Through TDAPA Under new regulations effective January 2020, New Chemical Entities (NCEs) are eligible for CMS reimbursement outside the bundle under the TDAPA* program • The intent of the TDAPA is to facilitate beneficiary access to certain new renal dialysis drug
Slide 15: CorMedix Believes DefenCath is Eligible for and Will Obtain TDAPA
CorMedix Believes DefenCath is Eligible for and Will Obtain TDAPA Highlights of Rationale to Support TDAPA FDA Fast-Track Designation Unmet Medical Need FDA Designated as Qualified Infectious Disease Product (QIDP) No standard of care has been established to prevent CRBSIs in hemodialysis pati
Slide 16: Commercial Execution Can Be Accomplished With a Highly Focused Organization
Commercial Execution Can Be Accomplished With a Highly Focused Organization Map of the standardized incidence rate of ESRD, by Health An initial commercial organization of ~50 people can provide Service Area, in the U.S. population, 2012 - present adequate coverage for launch into hemodialysis: • Th
Slide 17: Label Expansion Into Other CVC Areas Provides Opportunities
Label Expansion Into Other CVC Areas Provides Opportunities; Oncology has Compelling Dynamics • There are multiple natural extension opportunities for DefenCath beyond hemodialysis catheters Share with Estimated Patients Market: # of CLS Patient Population Central Venous (2019) per year 2025 • Among
Slide 18: Manufacturing Overview: Supply Chain Substantially Completed
Manufacturing Overview: Supply Chain Substantially Completed; Launch Quantities in Production • Successfully concluded technical transfer and validation of the drug product manufacturing process, which has enabled production at 2 different manufacturing locations • Company has DMF for taurolidine; p
Slide 19: Financial Highlights
Financial Highlights KEY STATISTICS • Exchange: NASDAQ Global Market • Common Stock: 38.0 million shares as of 3/25/2021 • Market cap: ~$350 million BALANCE SHEET • Pro forma Cash*: $87.8 million as of 12/31/2020 • Debt: None * Inclusive of net proceeds from recent ATM issuance. CORMEDIX 19
Slide 20: CorMedix Key Highlights
CorMedix Key Highlights Seeking Approval in Lead DefenCath is a Novel Indication in Kidney Product Addressing a Potential for 10.5 Years of Failure Patients Significant Unmet Market Exclusivity Receiving Hemodialysis Medical Need via CVCs Substantial Market Data Demonstrate Opportunities in Senior L
Slide 21: CORMEDIX
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