Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (February 2022)
20 slides from Cormedix's investor presentation, Feb 28, 2022
Slide 1: DefenCath: A potentially new standard-of-care in the prevention of catheter related blood stream infections
CORMEDIX DefenCath TM : A potentially new standard - of - care in the prevention of catheter related blood stream infections
Slide 2: Forward-Looking Statements
CORMEDIX 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 . These statemen
Slide 3: DefenCath is a Novel Product Targeting Substantial Market Opportunities
CORMEDIX DefenCath TM is a Novel Product Targeting Substantial Market Opportunities 3 • DefenCath is a novel catheter lock solution with the potential to change the standard of care in several large markets – no current pharmacologic agent approved to prevent infections associated with central venou
Slide 4: CorMedix Senior Management Team
CORMEDIX Matt David, MD Interim CEO, EVP and Chief Financial Officer Phoebe Mounts, PhD, JD EVP and General Counsel, Legal, Regulatory, Compliance & Technical Operations Tom Nusbickel EVP and Chief Commercial Officer Paul Chew, MD Adviser Chief Medical Officer * Liz Masson Hurlburt EVP & Head of Cli
Slide 5: Neutrolin/DefenCath Regulatory Status
CORMEDIX NEUTROLIN/DEFENCATH REGULATORY STATUS DefenCath TM / 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 clot ting 5 • In the EU, Neutrolin
Slide 6: Developing DefenCath: Multiple Potential Markets
CORMEDIX 6 Developing DefenCath : Multiple Potential Markets • 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
Slide 7: LOCK-IT-100 – Pivotal Clinical Trial Design
CORMEDIX DESIGN 7 OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINTS • 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 efficacy endpoint without safe
Slide 8: Phase 3 LOCK-IT-100 – Topline Results
CORMEDIX 0 0.1 0.2 0.3 0.4 0.5 0.6 Defencath Control 8 Interim Analysis Full Study Total CRBSIs (D / H) 28 (6 D / 22 H) 41 (9 D / 32 H) Total Subjects 653 795 DefenCath Reduced CRBSIs 72% 71% DefenCath (heparin control) Event Rates* 0.136 (0.491) 0.133 (0.465) p - value 0.0034 0.0006 *Event Rate is
Slide 9: Phase 3 LOCK-IT-100 – Conclusions
CORMEDIX 9 Phase 3 LOCK - IT - 100 – Conclusions LOCK - IT - 100, a landmark study, showed that in ESRD subjects with hemodialysis via a central venous catheter, DefenCath catheter lock solution significantly reduced catheter - related bloodstream infections by 71% (p=0.0006) in 795 patients (9 D, 3
Slide 10: DefenCath Regulatory Status
CORMEDIX 10 DefenCath Regulatory Status • DefenCath granted Fast Track designation by FDA recognizing potential to address unmet medical need • DefenCath NDA granted rolling submission of NDA by FDA and accepted for filing in 2020 based on data from LOCK - IT - 100 as substantial evidence of safety
Slide 11: Marketing Exclusivity and Intellectual Property
CORMEDIX Marketing Exclusivity and Intellectual Property 11 INTELLECTUAL PROPERTY PORTFOLIO • Patent portfolio consists of: » 7 issued U.S. patents and 17 pending U.S. patent applications » 14 issued foreign patents and 45 pending foreign patent applications • Additional patent applications to be fi
Slide 12: DefenCath Value can be Supported by Clinical and Economic Benefits to the Healthcare System
CORMEDIX • DefenCath’s value will be taken into consideration across indications and settings of care • The value will be determined by a combination of clinical innovation over current standard of care and strong pivotal trial data supported through regulatory interactions • Additionally, value wil
Slide 13: Medicare TDAPA reimbursement program
CORMEDIX • Medicare has a special reimbursement program to encourage innovation called TDAPA – Transitional Drug Add - on Payment Adjustment • The intent of the TDAPA is to facilitate beneficiary access to certain new renal dialysis drugs or biological products by allowing payment for these products
Slide 14: CorMedix Believes DefenCath is Eligible for and Will Obtain TDAPA
CORMEDIX CorMedix Believes DefenCath is Eligible for and Will Obtain TDAPA 14 x FDA Fast Track Designation x FDA Designated as Qualified Infectious Disease Product (QIDP) x Meets newness criteria as New Chemical Entity Regulatory Designations x Robust clinical data and highly statistically significa
Slide 15: CMS Focus on Quality
CORMEDIX CMS Focus on Quality • Medicare accounts for ~90% of all ESRD reimbursement • R ates all dialysis facilities on quality of care measures that are publicly available • Measures include infection rates, hospitalizations • Medicare is incorporating additional patient ratings on each dialysis f
Slide 16: Commercial Execution Can Be Accomplished With a Highly Focused Organization
CORMEDIX Commercial Execution Can Be Accomplished With a Highly Focused Organization 16 * In US, the largest dialysis providers include: DaVita, Fresenius, US Renal Care, Dialysis Clinic Inc., and American Renal Associates. Map of the standardized incidence rate of ESRD, by Health Service Area, in t
Slide 17: Manufacturing Overview: Supply Chain Substantially Completed
CORMEDIX Manufacturing Overview: Supply Chain Substantially Completed 17 • Successfully concluded technical transfer and validation of the drug product manufacturing process, which has enabled production at multiple manufacturing locations • Company has DMF for taurolidine; production process has be
Slide 18: Financial Highlights
CORMEDIX Financial Highlights 18 • Exchange: NASDAQ Global Market • Common Stock: 38.1 million shares as of 11/5/2021 • Market cap: ~$150 million • Cash*: $72.0 million as of 9/30/2021 • Debt: None KEY STATISTICS * Excluding restricted cash. BALANCE SHEET
Slide 19: CorMedix Key Highlights
CORMEDIX CorMedix Key Highlights 19 DefenCath is a Novel Product Addressing a Significant Unmet Medical Need Seeking Approval in Lead Indication in Kidney Failure Patients Receiving Chronic Hemodialysis via CVCs Potential for 10.5 Years of Market Exclusivity Data Demonstrate Effectiveness and Safety
Slide 20: UME
UME 4 vw piel SY Of-care in the prevention eter infectiéns, decreasing