MediWound Ltd. · NASDAQ:MDWD
MediWound — Investor Presentation (January 2025)
29 slides from MediWound's investor presentation, January 2025
Slide 1: Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair
Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair January 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 Validated enzymatic Significant commercial Diversified portfolio technology platform opportunity 14 successful clinical trials NexoBrid® - Eschar removal for severe burns NexoBrid® - 2024 revenue of $20M 120+ peer-reviewed publications EscharEx® - Debridement of chroni
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 Next-Gen enzymatic therapy for wound care3 Indication: Eschar removal in deep-partial and full thickness burns Targeted indication: Debridement of chronic/hard-to-heal wounds Classification: Orphan biological drug Cl
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 ® VLU debridement P3 to initiate Q1 2025 EscharEx Co
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® Strategic Head-to-Head study Human DFU Phase 2/3 VLU Phase 3 collaborations vs. collagenase Factor study initiation last patient out U
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: 14.8M No debt Scale-up will potentially increase €16.25M funding from EIC gross margin to 65% $115M+ received from BARDA $15M funded by DoD • Josh Jen
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: First Step in Burn Care - Eschar Removal
First Step in Burn Care - Eschar Removal 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 scarring medica
Slide 11: Non-Surgical, Simple, Selective, Effective
Non-Surgical, Simple, 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: $115M+ received from BARDA & DoD Contracts ▪ Easy-to
Slide 12: Phase 3 Studies Demonstrate Superiority
Phase 3 Studies Demonstrate Superiority1 Incidence of complete Time to complete Incidence of surgical Blood loss eschar removal eschar removal eschar removal (days) 815ml 814.51ml 93.3% 72% 1.0 P<0.0001 P<0.0001 P <0.0001 P<0.0001 0.5 4.0% 4% 14ml 0.0 0 10 20 30 40 NexoBrid N=75 SOC N=75 NexoBrid N=
Slide 13: Growth Supported by Facility Scale-Up
Growth Supported by Facility Scale-Up1 Full manufacturing capacity anticipated in 2025/6 NexoBrid® target revenue ($M) 40.0 34-382 35.0 30-332 2023 2024 2025 2026 30.0 Planning and 24-262 Initiation 25.0 Construction 20 20.0 FDA/EMA Submissions 15.0 6X Capacity 10.0 Increase1 EU US 5.0 0.0 2024 2025
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 VLU Venous Leg Ulcers DFU Diabetic Foot Ulcers Underlying pathology - Chronic venous insufficiency Underlying pathology - Diabetes (Type I/II) Affects - Lower leg or ankle Affects - Mostly bottom of the foot Ulcer characteristics - Large, shallow ulce
Slide 16: Chronic Ulcers: Current Debridement Treatments are Sub-Optimal
Chronic Ulcers: 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 + Au
Slide 17: EscharEx Enzymatic Debridement within Days
EscharEx Enzymatic Debridement within Days ® Indication: Rapid debridement and promotion of healthy granulation tissue (WBP) in chronic and hard-to-heal wounds1,2 Status: Investigational drug ▪ Debrides chronic ulcers within 4-8 daily administrations ▪ Reduces bacteria and biofilm ▪ Easy-to-use topi
Slide 18: Robust and Consistent Results in Three Phase 2 Studies
Robust and Consistent Results in Three Phase 2 Studies 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 VLU,
Slide 19: ChronEx Phase 2 Study - Endpoints Significantly Met
ChronEx Phase 2 Study1 - Endpoints Significantly Met Complete debridement within 2 weeks Time to complete debridement (primary endpoint) 63% P < 0.001 % Patients P = 0.004 30% 13% P = 0.016 P = 0.004 EscharEx® Placebo NSSOC n = 46 n = 43 n = 30 EscharEx is superior to placebo and non-surgical SOC (N
Slide 20: ChronEx Phase 2 Study - Rapid Wound Bed Preparation Achieved
ChronEx Phase 2 Study1 - Rapid Wound Bed Preparation Achieved Incidence of WBP Time to WBP WBP & Healing 50% P < 0.001 Subjects reaching WBP are 4.1X more likely to achieve P = 0.01 wound closure (p = 0.0004) 25% Significant correlation of WBP vs. time to wound closure. P = 0.011 HR2 of 11.96 (p < 0
Slide 21: PharmEx Phase 2 Study - Surpassing Traditional Debridement
PharmEx Phase 2 Study - Surpassing Traditional Debridement Reduction in wound size, biofilm and bacterial burden2 35% 65% 70% 100% Wound size reduced by end Bioburden reduction by end Complete debridement Biofilm reduced for patients of two-week follow-up of treatment within 8 applications positive
Slide 22: EscharEx Well-Positioned to Become Market Leader
EscharEx® Well-Positioned to Become Market Leader1 EscharEx® SANTYL® Approved in the 1960s; $375M+ annual revenues (2023) Investigational drug - Phase 3 expected to begin in 1Q 2025 Existing reimbursement code2 Mixture of enzymes; multiple targets of action Collagenase; single target of action Debri
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 Study in VLU Patients
EscharEx® VALUE Phase 3 Study 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 Planned Phase 2/3 Study in DFU Patients
EscharEx® Planned Phase 2/3 Study 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 wi
Slide 26: Primary Research Shows EscharEx Transforms Market
Primary Research Shows EscharEx Transforms 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 max
Slide 27: $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 Estimated 2028 total patient population2 2.42M DFU and 1.68M VLU, (4.10M total) ~4.10M DFU: 2.42M VLU:1.68M DFU & VLU debridement patients ~2.98M Percent of patients undergoing debridement quantified through survey and refined via
Slide 28: 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 28
Slide 29: 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