Cormedix Inc. · NASDAQ:CRMD
Cormedix — Cantor Global Healthcare Conference 2019
26 slides from Cormedix's conference presentation, Oct 3, 2019
Slide 1: Harnessing Taurolidine Technology
HarnessingTaurolidine Technology Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance Cantor Global Healthcare Conference October 3, 2019 CORMEDIX 1
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: Financial Summary
FINANCIAL SUMMARY Founded January 2006 Exchange: Ticker NYSE American: CRMD Headquarters Berkeley Heights, NJ Employees (U.S.) 23 Common Stock O/S 25.6 Million Pref/CS Equivalents 6.1 Million Warrants Outstanding 0.3 Million Cash at June 30, 2019 $26.4 Million Share Price at Sept. 30, 2019 $6.80 Mar
Slide 4: Mission Statement
MISSION STATEMENT To harness our taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases First commercial product candidate in the US: Neutrolin® A novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstrea
Slide 5: Corporate Highlights
CORPORATE HIGHLIGHTS NEUTROLIN SIGNIFICANT MARKET OPPORTUNITY Non-antibiotic antimicrobial solution designed to prevent costly and Current estimates of annual need for catheter lock solutions in the U.S. for dangerous bloodstream infections associated with the use of central hemodialysis alone are a
Slide 6: Commercial Opportunity
COMMERCIAL OPPORTUNITY Neutrolin’s U.S. commercial opportunity as a catheter lock solution for hemodialysis and additional indications SIGNIFICANT UNMET NEED MARKET SIZE • Over 180 extensive interviews with nephrologists, oncologists, TPN healthcare providers have reconfirmed significant unmet need
Slide 7: 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 both infection and thrombosis from central venous catheters used in adult hemodialysis • Pricing will be based on the offsets Neutrolin provides to the broad econo
Slide 8: 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 9: 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. E
Slide 10: Neutrolin: Non-antibiotic Anti-infective To Prevent CRBSI
KEY BENEFITS OF NEUTROLIN® NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI Prevents and reduces bloodstream infection. Bacteria and fungi, Antibiotic- NEUTROLIN® resistant strains, No reported resistance in Proprietary Formulation a clinical setting Taurolidine – 1.35% (anti-infective, ant
Slide 11: FDA Recognizes Potential of Neutrolin
FDA RECOGNIZES POTENTIAL OF NEUTROLIN APPROVAL PATHWAY Designated an investigational new drug by FDA (Catheter LOCK Solution Investigational Trial) 10.5 YEARS Granted New Chemical Entity (NCE) Status 5 years exclusivity Potential Market Exclusivity Granted Qualified Infectious Disease Product (QIDP)
Slide 12: 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 SIGNIFICANT UNMET NEED 250,000 catheter-related bloodstream infections
Slide 13: Neutrolin: No Microbial Resistance, Broad Spectrum Coverage
NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI NO MICROBIAL RESISTANCE SHOWN BROAD SPECTRUM OF TAUROLIDINE COVERAGE Adaptation of microorganisms to taurolidine has Gram Positive Microorganisms not yet emerged as a factor in the pathogenesis Coagulase-negative Staphylococcus species and of
Slide 14: LOCK-IT-100 Preventing CRBSI in Dialysis Patients
LOCK-IT 100 PREVENTING CRBSI IN DIALYSIS PATIENTS DESIGN OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINTS Phase 3, multicenter, double- Demonstrate the efficacy and Time to occurrence of CRBSI Catheter patency blind, randomized (1:1), active safety of Neutrolin® as a control (heparin) catheter lock so
Slide 15: LOCK-IT-100 Baseline Demographics (I)
LOCK-IT 100 BASELINE DEMOGRAPHICS (l) Demographic Neutrolin (403) % Heparin (403) % Mean age (years) (SD) 60.8 (14.22) 60.9 (14.39) <65 years (%) 59.3 58.6 ≥ 65 to < 75 years (%) 24.6 23.6 ≥ 75 years (%) 16.1 17.9 Female (%) 45.7 38.2 White (%) 61.5 65.0 Black or African-American (%) 31.3 27.8 Asian
Slide 16: LOCK-IT-100 Baseline Demographics (II)
LOCK-IT 100 BASELINE DEMOGRAPHICS (ll) Demographic Neutrolin (403) % Heparin (403) % Diabetes (%) 69.0 68.7 BMI (mean) kg/m2 29.7 29.2 Months Since 1st Dialysis (SD) 21.2 (37.5) 19.8 (37.0) ≤ 12 Months on Dialysis (%) 67.5 68.5 Internal Jugular CVC (%) 92.1 90.6 Subclavian CVC (%) 7.4 7.7 Other CVC
Slide 17: Topline Results of LOCK-IT-100 Study
TOPLINE RESULTS OF LOCK-IT 100 STUDY Interim Analysis Full Study Total CRBSIs 28 41 Total Subjects 653 795 Neutrolin Reduced CRBSIs by: 72% 71% Neutrolin (control) Event Rates* 0.136 (0.491) 0.133 (0.465) p-value 0.0034 0.0006 0.6 0.6 0.5 -72% 0.5 -71% 0.4 0.4 0.3 0.3 c c 0.2 0.2 0.1 0.1 0 0 Neutrol
Slide 18: Secondary Endpoints: No Statistically Significant Differences
SECONDARY ENDPOINTS: NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN NEUTROLIN & CONTROL ARMS Catheter Removal: p=0.416 v Neutrolin (n=397) Control Arm (n=398) Event Rate* 3.48 3.23 Subjects 236 out of 397 225 out of 398 Loss of Catheter Patency: p=0.12 v Neutrolin Control Arm Event Rate* 0.99 0.74
Slide 19: LOCK-IT-100 Secondary Endpoint: Catheter Removal for Positive Reasons
LOCK-IT 100 SECONDARY ENDPOINT Catheter Removal for Positive Reasons Full Population Analysis at 41 CRBSIs Post-Hoc Neutrolin Heparin (N=397) (N=398) No Longer Needed for HD 162 131 Improved Renal Function 0 1 Total Removals-Positive Reasons 162 (41) 132 (33) Total Catheter-Days Follow-up 67,780 69,
Slide 20: LOCK-IT-100 Secondary Endpoint: Catheter Removal for Negative Reasons
LOCK-IT 100 SECONDARY ENDPOINT 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-Days F
Slide 21: LOCK-IT-100 Secondary Endpoint: Loss of Catheter Patency
LOCK-IT 100 SECONDARY ENDPOINT Loss of Catheter Patency Full Population Analysis at 41 CRBSIs Post-Hoc Neutrolin (N=397) Heparin (N=398) (%) (%) Loss of Catheter Patency (%) 63 (16) 48 (12) rt-PA for Loss of Patency (%) 46 (12) 33 (8.3) CR for Loss of Patency (%) 17 (4.3) 15 (3.8) Total Catheter Day
Slide 22: 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 1.3 3.
Slide 23: Conclusion
CONCLUSION 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, a leading cause of mortality in HD Compared to heparin, there was no significan
Slide 24: 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 CORMEDIX 24
Slide 25: Current CorMedix Pipeline
CURRENT CORMEDIX PIPELINE DRUG PIPELINE Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Hemodialysis Stopped for Efficacy at Interim Review: FDA Discussions Ongoing Neutrolin® U.S. Oncology ICU / CCU CMDX-001 Pediatric Neuroblastoma* * Orphan Drug Designation MEDICAL DEVICE
Slide 26: Thank You
NYSE American: CRMD @CorMedixInc @Investor & Media Contacts THANK LifeSci Advisors, LLC Dan Ferry [email protected] YOU 617-535-7746 400 Connell Drive Suite 5000 Berkeley Heights, NJ 908.517.9500 CORMEDIX 26