Mediwound Ltd. · NASDAQ:MDWD
Mediwound — Investor Presentation (March 2025)
30 slides from Mediwound's investor presentation, March 2025
Slide 1: Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair
Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair March 2025 I Nasdaq: MDWD
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws, including but not limited to the statements related to the commercial potential of our products a
Slide 3: MediWound Company Highlights
MediWound Company Highlights Significant commercial Validated enzymatic Strategic global opportunity technology platform collaborations 14 successful clinical trials Vericel, Mölnlycke, Kaken, MIMEDX, BARDA, 120+ peer-reviewed publications Mankind, Solventum, Coloplast, EIC, DoD, NexoBrid® Key appro
Slide 4: Core Platform - Enzymatic Technology
Core Platform - Enzymatic Technology Healthy skin Proprietary IP protected manufacturing process Damaged skin Complex mixture of enzymes Pineapple stem Protein harvest extraction Post application Purification, enrichment, Complex mixture of stabilization proteolytic enzymes Rapid removal of non-viab
Slide 5: Multi-Billion Dollar Portfolio
Multi-Billion Dollar Portfolio NexoBrid® EscharEx® Disruptive therapy for burn care Investigational Next-Gen enzymatic therapy for wound care Indication: Eschar removal in deep-partial and full thickness burns Targeted indication: Debridement of chronic/hard-to-heal wounds Classification: Orphan bio
Slide 6: Product Pipeline
Product Pipeline Indication Development Phase 1 Phase 2 Phase 3 Registration Marketed Adult burn eschar removal Approved Pediatric burn eschar removal Approved Collaborations: Battlefield burn eschar removal DoD1 funded Blast injury treatment POC2 EscharEx ® VLU debridement Interim assessment mid-20
Slide 7: Value Creating Milestones
Value Creating Milestones 2024 2025 2026 Phase 2 positive VLU Phase 3 DFU protocol discussions PK study VLU Phase 3 results initiation with FDA/EMA interim EscharEx® Mölnlycke DFU/VLU strategic Head-to-Head trial Human DFU Phase 2/3 VLU Phase 3 collaboration collaborations vs. collagenase initiation
Slide 8: Financial Highlights
Financial Highlights BALANCE SHEET REVENUE EQUITY $44M in cash1 2024 revenue of $20M Outstanding shares: 10.8M NexoBrid® is profitable Fully diluted: 14.8M2 No debt Scale-up will potentially increase €16.25M funding from EIC gross margin to 65% $115M+ received from BARDA $15M funded by DoD • Swayamp
Slide 9: Early, effective and selective non-surgical eschar removal for severe burns
Early, effective and selective non-surgical eschar removal for severe burns (8.8% concentration) Validated & commercialized Approved in 40+ countries including US, EU, JP; 14,000+ patients treated to date
Slide 10: Eschar Removal - Critical First Step in Burn Care
Eschar Removal - Critical First Step in Burn Care Removal of non-viable tissue is critical Surgical removal of eschar is for wound healing traumatic & non-selective1,2 Eschar Prevents infection Stops deterioration Reveals tissue for Loss of healthy Challenging Requires surgical and sepsis and scarri
Slide 11: NexoBrid - Non-Surgical, Selective, Effective
NexoBrid® - Non-Surgical, Selective, Effective Indication: Eschar removal of deep partial-thickness and/or full-thickness thermal burns Commercial availability: US (Vericel), Japan (Kaken), Europe (direct, and PMI), India (Mankind) Government support: $115M+ received from BARDA & DoD Contracts Eas
Slide 12: Phase 3 Studies Demonstrated Superiority
Phase 3 Studies Demonstrated Superiority1 Incidence of complete Time to complete Incidence of surgical Blood loss eschar removal eschar removal eschar removal (days) 815ml 814.51ml 93.3% 72% 100% p<0.0001 p<0.0001 p <0.0001 p<0.0001 50% 4.0% 4% 14ml 0% 0 10 20 30 40 NexoBrid N=75 SOC N=75 NexoBrid N
Slide 13: Facility Scale-Up Supports Future Growth
Facility Scale-Up1 Supports Future Growth Full manufacturing capacity anticipated in 2025/6 NexoBrid® target revenue ($M) 40.0 34-382 35.0 30-332 2023 2024 2025 2026 30.0 Planning and 24-26 Initiation 25.0 Construction 20 20.0 FDA/EMA Submissions 15.0 6X Capacity 10.0 Increase1 EU US 5.0 0.0 2024 20
Slide 14: Next-Generation Enzymatic Debridement Candidate for Chronic Wounds
Next-Generation Enzymatic Debridement Candidate for Chronic Wounds (5% concentration) Superior to SOC - De-risked - validated technology $2.5B TAM opportunity aims to set a new bar for efficacy and successful Phase 2 trials
Slide 15: EscharEx Targets Lower Extremity Chronic Ulcers
EscharEx® Targets Lower Extremity Chronic Ulcers Venous leg ulcers Diabetic foot ulcers (VLU) (DFU) Underlying pathology Chronic venous insufficiency Diabetes (Type I/II) Affected area Lower leg or ankle Mostly bottom of the foot Ulcer characteristics Large, shallow ulcers; moderate/severe pain Smal
Slide 16: Current Debridement Treatments are Sub-Optimal
Current Debridement Treatments are Sub-Optimal Modalities by efficacy and complexity Modalities by ulcer type (U.S.)1 100% 2% 3% 3% Other Surgical EscharEx® 3% 15% 7% Mechanical Only 3% Ultrasonic 80% 1% 4% 10% 5% Non-sharp Combo 5% 9% (without Enzymatic) Biological 1% 60% Sharp + Autolytic 11% Effi
Slide 17: EscharEx Achieves Enzymatic Debridement within Days
EscharEx® Achieves Enzymatic Debridement within Days1 Target Indication: Rapid debridement and promotion of healthy granulation tissue (WBP)2 in chronic and hard-to-heal wounds Status: Investigational drug Debrides chronic ulcers within 4-8 daily administrations Reduces bacteria and biofilm Ea
Slide 18: Three Phase 2 Studies Show Robust and Consistent Results
Three Phase 2 Studies Show Robust and Consistent Results WEEKLY SCREENING DAILY FOLLOWUP NON-SURGICAL SOC 2w 14w EscharEx n=46 RANDOMIZATION ChronEx1 Placebo n=43 ✓ Debridement VLU ✓ Wound Bed Preparation SOC n=30 ✓ Debridement ✓ Wound Bed Preparation PharmEx2 EscharEx n=12 ✓ Wound size reduction VL
Slide 19: Phase 2 MW-EX01 Trial: EscharEx Effective in Both VLU and DFU
Phase 2 MW-EX01 Trial1: EscharEx® Effective in Both VLU and DFU Incidence of complete debridement (VLU, DFU, Traumatic ulcers) 93% of the patients who 55% completed debridement with EscharEx®, achieved full 29% debridement within 7 days p = 0.04 (4-5 daily applications) EscharEx Placebo n = 49 n = 2
Slide 20: Phase 2 ChronEx Trial in VLU: Endpoints Significantly Met
Phase 2 ChronEx Trial1 in VLU: Endpoints Significantly Met Complete debridement within 2 weeks Time to wound bed prepared (primary endpoint) 63% p < 0.001 p = 0.004 30% 13% p = 0.011 p = 0.004 EscharEx® Placebo NSSOC n = 46 n = 43 n = 30 EscharEx 63% vs. placebo 30% EscharEx 11 days vs. placebo 85 d
Slide 21: Phase 2 PharmEx Trial: EscharEx Surpasses Traditional Debridement
Phase 2 PharmEx Trial1: EscharEx® Surpasses Traditional Debridement2 70% 64% 35% 100% Complete debridement achieved Bioburden reduced Wound size reduced Biofilm substantially reduced within 8 applications by end of treatment by end of two-week for all patients positive for biofilm (avg 3.9 applicati
Slide 22: EscharEx Well-Positioned to Become Market Leader
EscharEx® Well-Positioned to Become Market Leader1 EscharEx® SANTYL® Approved in the 1960s; $372M annual revenues (2023) Investigational drug - Phase 3 Existing reimbursement code2 Mixture of enzymes; multiple targets of action Collagenase; single target of action Debridement, promotion of granulati
Slide 23: EscharEx vs. SANTYL Head-to-Head Data
EscharEx® vs. SANTYL® Head-to-Head Data1 Incidence of complete Time to achieve WBP Time to wound closure Patient-reported pain2 debridement in 2 weeks p=0.05 p=0.014 p=0.001 Consistent results in pediatric Phase 3 study, EU Phase 3 study and post marketing data2 1. Post-hoc data from the ChronEx Pha
Slide 24: EscharEx VALUE Phase 3 Trial in VLU Patients
EscharEx® VALUE Phase 3 Trial in VLU Patients STUDY DESIGN ENDPOINTS A global (US, EU, ROW), randomized, double blind, adaptive design study in VLU patients Co-primary: Incidence of complete debridement STUDY Two arms: EscharEx vs. placebo, 1:1 ratio Incidence of complete wound closure OBJECTIVES Sa
Slide 25: EscharEx Head-2-Head Phase 2 Trial in VLU Patients
EscharEx® Head-2-Head Phase 2 Trial in VLU Patients STUDY DESIGN ENDPOINTS A global (US, EU) prospective, randomized, double blind study in VLU patients Primary: • Safety and tolerability STUDY Three arms: EscharEx vs placebo vs collagenase1 • Change in pain OBJECTIVES 1:1:1 ratio • Infection rate •
Slide 26: EscharEx Phase 2/3 Trial in DFU Patients
EscharEx® Phase 2/3 Trial in DFU Patients STUDY DESIGN ENDPOINTS A global (US, EU, ROW), randomized, double blind, adaptive design study in patients with DFUs Co-primary: Incidence of complete debridement STUDY Three arms: EscharEx, placebo and SOC (SOC Incidence of complete wound closure will be dr
Slide 27: Primary Research: EscharEx to Transform the Market
Primary Research: EscharEx to Transform the Market1 All care settings report2 strong drivers for adoption EscharEx draws share across all debridement modalities6 SANTYL 3 18% 30% EscharEx 4 5 Ease of use Reduced treatment duration Reduction readmission risk Accelerated wound healing Reimbursement ma
Slide 28: $725M Projected Peak Sales in $2.5B TAM in U.S.
$725M Projected Peak Sales in $2.5B TAM in U.S.1 DFU & VLU prevalence ~4.10M Estimated 2028 total patient population2 2.42M DFU and 1.68M VLU, (4.10M total) DFU: 2.42M VLU:1.68M DFU & VLU debridement patients ~2.98M Percent of patients undergoing debridement quantified through survey and refined via
Slide 29: Highly Experienced Leadership Team
Highly Experienced Leadership Team Nachum (Homi) Shamir Ofer Gonen Dr. Shmulik Hess Dr. Ety Klinger Barry Wolfenson Hani Luxenburg Dr. Robert J. Snyder Chairman CEO COO & CCO Chief R&D Officer EVP Strategy & Corp Dev. CFO CMO 29
Slide 30: Strategic Timeline
Strategic Timeline NexoBrid U.S. launch NexoBrid EscharEx VLU Phase 3 EscharEx $24-26M revenue Interim assessment; FDA approval Last patient out $25M PIPE + €16.25M EIC EscharEx VLU Phase 3 EscharEx DFU U.S. based funding execution Phase 2/3 initiation manufacturing facility Mölnlycke EscharEx vs. c