Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (January 2020)
21 slides from Cormedix's investor presentation, January 2020
Slide 1: CorMedix 2020 Corporate Presentation
¥ CorMedix | —— 4 ‘es * md | ts ee A potentially new standard-of-, sGarre imythe rp . 4 reventiom of central venou ea infections, ‘ dg€reasing Vee Ions cate o/; ¢ be \ ae 2020 ’ Fy aie . Jo\ FE -
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: Investment Highlights
INVESTMENT HIGHLIGHTS • Phase 3 trial completed; NDA filing expected in 2020 for lead indication, catheter lock solution for hemodialysis patients Potential Approval in 2H20 • Novel non-antibiotic, anti-infective product candidate with potential to change the standard of care in several large market
Slide 4: Neutrolin - Non-antibiotic Anti-infective Designed to Prevent CRBSIs
NEUTROLIN® - Non-antibiotic Anti-infective Designed to Prevent CRBSIs • Phase 3 LOCK-IT-100 trial demonstrated 71% reduction in CRBSIs (p=0.0006) in 795 ESRD patients • Neutrolin® is used to fill catheter lumens when they are not in use to prevent clotting and antimicrobial growth NEUTROLIN® - PROPR
Slide 5: Regulatory Status
REGULATORY STATUS RECENT PROGRESS Pre-NDA discussions with FDA completed 4Q 2019 – confirmed eligibility for priority review, submissionunder rolling review and LPAD Discussed potential development path for additional indications of use with FDA Meeting with FDA on CMC information for NDA; sel
Slide 6: Medical Opportunity
MEDICAL OPPORTUNITY Despite improvements and initiatives to control infection, catheter biofilm develops within 24 hours and can lead to life-threatening infections, costing the U.S. healthcare system billions of dollars annually THE CORMEDIX SOLUTION • Current Standard of Care: • The CorMedix Solut
Slide 7: Commercial Opportunity
COMMERCIAL OPPORTUNITY • No pharmacologic agents approved in the U.S. for the prevention of CRBSI in central venous catheters • Market research firm which has conducted similar research on over 100 new products ranked receptivity to Neutrolin® among the top 10% of all products tested across any dise
Slide 8: Phase 3 LOCK-IT-100 - Design
PHASE 3 LOCK-IT-100 - DESIGN The Data Safety Monitoring Board • Phase 3, multicenter, double-blind, randomized (1:1), active control (heparin) recommended the study be terminated early because the pre- specified level of significance had DESIGN • Event-driven: 56 CRBSI events required to complete th
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, Neutrolin® catheter lock solution significantly reduced catheter- related bloodstream infections by 71% (p=0.0006) in 795 patients Compared to heparin, th
Slide 10: LOCK-IT-100 - Topline Results
LOCK-IT-100 - TOPLINE RESULTS Interim Analysis Full Study Total CRBSIs 28 41 Total Subjects 653 795 Neutrolin® Reduced CRBSIs by: 72% 71% Neutrolin® (heparin control) Event 0.136 (0.491) 0.133 (0.465) Rates* p-value 0.0034 0.0006 0.6 0.6 -72% 0.5 -71% 0.5 0.4 0.4 0.3 0.3 0.2 0.2 0.1 0.1 0 0 Neutroli
Slide 11: LOCK-IT-100 - Secondary Endpoints
LOCK-IT-100 - SECONDARY ENDPOINTS NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN NEUTROLIN® & HEPARIN CONTROL ARM Loss of Catheter Patency: p=0.12 Catheter Removal: p=0.416 Control Arm Neutrolin® Control Arm Neutrolin® (n=397) (n=398) Event Rate* 0.99 0.74 Event Rate* 3.48 3.23 Subjects 63 out of
Slide 12: LOCK-IT-100 - Secondary Endpoints
LOCK-IT-100 - SECONDARY ENDPOINTS CATHETER REMOVAL FOR NEGATIVE REASONS FULL POPULATION ANALYSIS AT 41 CRBSIs POST-HOC Neutrolin® Heparin (N=397) (N=398) CRBSI (%) 8 (2.0) 29 (7.3) All Cath. Malfunction-Dysfunction (%) 62 (16) 57 (14) Other (%) 4 (1.0) 7 (1.8) Total 74 (19) 93 (23) Total Catheter-Da
Slide 13: LOCK-IT-100 - Safety
LOCK-IT-100 - SAFETY Treatment Emergent Serious Adverse Events Incidence ≥ 2% in Either Treatment Arm (Safety Population) Deaths & AE Preferred Terms Neutrolin® (N=398) % Heparin (N=399) % Deaths 4.5 5.3 Device-related Infection 1.5 2.0 Pneumonia 3.0 5.3 Sepsis 2.3 3.5 Acute Myocardial Infarction 1.
Slide 14: Neutrolin Value-Based Pricing Considerations
NEUTROLIN® VALUE-BASED PRICING CONSIDERATIONS Upon approval, Neutrolin® will be the first and only drug in the U.S. indicated to prevent catheter- related infections in hemodialysis patients • Pricing will be based on the offsets Neutrolin® provides to the broad economic burden on the U.S. healthcar
Slide 15: Medicare's Role in ESRD Reimbursement
MEDICARE’S ROLE IN ESRD REIMBURSEMENT Timing of Medicare Coverage for Dialysis Patients Payer Mix for Dialysis Patients Prior Dialysis 1 Month 4 Months 31 Months 34 Months Coverage Setting 19% Medicaid Medicare Facility Primary Primary ~1% Medicaid 36% 7% Medicare Home Primary 10% Employer Medicare
Slide 16: Neutrolin Reimbursement Opportunity
NEUTROLIN® REIMBURSEMENT OPPORTUNITY Under new regulations effective January 2020, New Chemical Entities (NCEs) are eligible for CMS reimbursement outside the bundle under the TDAPA* program. If approved under TDAPA, reimbursement of Neutrolin® would be calculated based on its average selling price.
Slide 17: Current CorMedix Pipeline
CURRENT CORMEDIX PIPELINE DRUG PIPELINE Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Hemodialysis Trial Completed; NDA in preparation Neutrolin® U.S. Oncology ICU / CCU CRMD-005 Pediatric Neuroblastoma* * Orphan Drug Designation MEDICAL DEVICE PIPELINE Product Category In
Slide 18: Intellectual Property & Manufacturing Overview
INTELLECTUAL PROPERTY & MANUFACTURING OVERVIEW INTELLECTUAL PROPERTY MANUFACTURING & SUPPLY • Patent portfolio consists of: • Successfully concluded technical transfer and validation of manufacturing process, which has enabled production at 3 7 issued U.S. patents and 17 pending U.S. patent differ
Slide 19: CorMedix Management Team
CORMEDIX MANAGEMENT TEAM Khoso Baluch Chief Executive Officer Robert Cook Chief Financial Officer Phoebe Mounts, EVP and General Counsel PhD, JD Paul Chew, MD Chief Medical Officer Jack Armstrong EVP Technical Operations Elizabeth Masson EVP & Head Of Clinical Operations Hurlburt CORMEDIX 19
Slide 20: Investment Highlights
INVESTMENT HIGHLIGHTS • Phase 3 trial completed; NDA filing expected in 2020 for lead indication, catheter lock solution for hemodialysis patients Potential Approval in 2H20 • Novel non-antibiotic, anti-infective product candidate with potential to change the standard of care in several large market
Slide 21: CorMedix
ard of i 1 lA >, . years easing hospitalizations and death. im the prevention of central a laa ~ ‘ a" t = De » ia