Mediwound Ltd. · NASDAQ:MDWD
Mediwound — Investor Presentation (August 2024)
28 slides from Mediwound's investor presentation, Aug 14, 2024
Slide 1: Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair
August 2024 I Nasdaq: MDWD Next - Generation Enzymatic Therapeutics for Non - Surgical Tissue Repair
Slide 2: Cautionary Note Regarding Forward-Looking Statements
2 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 pr
Slide 3: MediWound - Company Highlights
Validated enzymatic technology platform Vericel, Mölnlycke, Kaken, Solventum , MiMedx , BARDA, DoD , PolyMedics , BSV S trategic g lobal collaborations Solid balance sheet with strong investor base 3 MediWound - Company Highlights 1 . Investigational drug 2 . Oliver Wyman (OW) primary research. 3 .
Slide 4: Core Platform - Enzymatic Technology
Proprietary IP protected manufacturing process 4 Core Platform - Enzymatic Technology Pineapple stem harvest Protein extraction Purification, enrichment, stabilization Healthy skin Damaged skin Complex mixture of enzymes Rapid removal of non - viable tissue without surgery Post application Complex m
Slide 5: Multi-Billion Dollar Portfolio
5 Multi - Billion Dollar Portfolio 1 . Investigational drug 2 . ~ 90 % of eligible patients require eschar removal; assumes NexoBrid average price of ~$ 9,000 per patient 3 . TAM - targeted addressable market; Oliver Wyman market research Indication: Eschar removal of deep partial and full thickness
Slide 6: Product Pipeline
6 Product Pipeline 1 . Supplemental BLA 2 . U.S. Department of Defense 3 . Investigator - Initiated Trial 4 . Venous Leg Ulcers 5 . Diabetic Foot Ulcers 6 . European Innovation Council VLU 4 debridement DFU 5 debridement Post traumatic wound debridement P 2 / 3 preparations underway; EIC 6 funded P
Slide 7: Value Creating Milestones
2024 2023 7 Value Creating Milestones FDA approval Phase 2 positive results Protocol submissions Strategic research collaborations EU pediatric label extension US/JPN launch Scale - up facility completion Battlefield use Manufacturing facility FDA decision pediatric label extension BLA supporting ac
Slide 8: Financial Highlights
Financial Highlights 8 1 . As of June 30 , 2024 , including proceeds from the PIPE transaction dated July 15 , 2024 . This does not reflect the EIC grant $ 51 M in cash 1 No debt BALANCE SHEET 2023 revenue of ~ $ 19 M NexoBrid ® is profitable Scale - up will potentially increase gross margin ~ 65 %
Slide 9: Early, effective and selective non-surgical eschar removal for severe burns
Early, effective and selective non - surgical eschar removal for severe burns Validated & commercialized Approved in 40 + countries including US, EU, JP; 12,000 + patients to date ( 8.8 % concentration)
Slide 10: First Step in Burn Care - Eschar Removal
1 . Edmondson et al., 2018 ; Burns 2 . Gurfinkel et al., 2010 ; Can J Plast Surg 10 First Step in Burn Care - Eschar Removal Removal of non - viable tissue is critical for wound healing Loss of healthy tissue and blood Surgical removal of eschar is traumatic & non - selective 1,2 Prevents infection
Slide 11: NexoBrid: 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), and India (BSV) Government support: $ 115 M+ received from BARDA & DoD Contracts 11 Non - Surgical, Simple, Selective, Effecti
Slide 12: Phase 3 Studies Demonstrate Superiority
1 . Shoham et al. 2023 ; Journal of Burn care & Research 2 . Pediatric Phase 3 (CIDS), EU Phase 3 , Expanded Access Protocol (NEXT) 3 . Shoham et al. 2023 ; IWJ 12 Phase 3 Studies Demonstrate Superiority 1 Consistent across various studies 2 and post - marketing data 3 Safe and well - tolerated Impr
Slide 13: Growth Supported by Facility Scale-Up
Global demand exceeds our current manufacturing capability 3 - fold 13 Growth Supported by Facility Scale - Up Planning and Initiation 2023 2024 2025 Construction FDA/ EMA Submissions 6 X Capacity Increase 19 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 2023 2024 2025 2026 BARDA/DoD NexoBrid Commercia
Slide 14: Next-Generation Enzymatic Debridement Candidate for Chronic Wounds
Potentially superior to SOC - aims to set a new bar for efficacy $ 2 B TAM opportunity De - risked - validated technology and successful Phase 2 trials Next - Generation Enzymatic Debridement Candidate for Chronic Wounds ( 5 % concentration)
Slide 15: EscharEx Targets Lower Extremity Chronic Ulcers
Debridement is a critical first step towards healing in both VLU and DFU 15 EscharEx ® Targets Lower Extremity Chronic Ulcers VLU Venous Leg Ulcers Underlying pathology - C hronic venous insufficiency Affects - Lower leg or ankle Ulcer characteristics - Larger , shallow er ulcers; m oderate / severe
Slide 16: Chronic Ulcers: Current Debridement Treatments are Sub-Optimal
Modalities by Efficacy and Complexity Modalities by Ulcer Type (U.S.) 1 Efficacy Trained Specialist Untrained HCP/ Nurses Ultrasonic Hydrosurgery Biological Sharp Current Enzymatic Autolytic 22 % 28 % 11 % 6 % 15 % 22 % 3 % 1 % 20 % 11 % 21 % 21 % 3 % 5 % 5 % 6 % 0% 20% 40% 60% 80% 100% VLU DFU Othe
Slide 17: EscharEx: Enzymatic Debridement within Days
Enzymatic Debridement within Days ▪ Easy to use daily topical application designed for all patient settings ▪ Debrides chronic ulcers within 4 - 8 daily applications ▪ Promotes granulation tissue ▪ Reduces bacteria & biofilm ▪ In - line with current treatment workflows and reimbursement landscape 17
Slide 18: Successfully Evaluated in Three Phase Studies
Successfully Evaluated in Three Phase 2 Studies 18 SCREENING DAILY WEEKLY NON - SURGICAL SOC FOLLOWUP PharmEx 2 VLU, DFU EscharEx n= 12 MW - EX 01 3 VLU, DFU, Traumatic EscharEx n= 73 Placebo n= 38 ChronEx 1 VLU EscharEx n= 46 Placebo n= 43 SOC n= 30 RANDOMIZATION ✓ Debridement ✓ Wound Bed Preparati
Slide 19: Phase 2 Study 1 - Endpoints Significantly Met
1 . Shoham et al. 2024 ; eClinicalMedicine 2 . Snyder et al. 2023 ; Wounds Journal; Shoham et al. 2021 ; Wound Rep Reg 19 Phase 2 Study 1 - Endpoints Significantly Met No safety issues observed; efficacy results consistent with previous Phase 2 studies 2 EscharEx is superior to Gel Vehicle and Non -
Slide 20: Phase 2 Study 1 - Rapid Wound Bed Preparation Achieved
Time to WBP Incidence of WBP 1 . Shoham et al. 2024 ; eClinicalMedicine 2 . Hazard Ratio 20 Phase 2 Study 1 - Rapid Wound Bed Preparation (WBP) Achieved 50 % 25 % 10 % EscharEx N = 23 Gel Vehicle N = 11 NSSOC N = 3 Study suggests that faster wound bed preparation increases the probability of wound c
Slide 21: Phase 2 Pharmacology Study - Beyond Traditional Debridement
1 . Snyder et al., 2023 ; Wounds Journal 2 . The PharmEx trial included VLU and DFU patients 21 Phase 2 Pharmacology Study 1 - Beyond Traditional Debridement 2 Results showed reduction in wound size, biofilm and bacterial burden 64 % 35 % 100 % Bioburden reduced by end of treatment Wound size reduce
Slide 22: EscharEx Well-Positioned to Become Market Leader
1 . The comparison presented represent cross - trial comparison 2 . OW Primary Research 3 . Lantis JC and Gordon I., 2017 ; Wounds 4 . Patry et al., 2017 5 . Snyder et al., 2023 ; Wounds 6 . SOC in the Phase 2 trial included SANTYL ® 7 . Based on the data to date 8 . SANTYL ® PI 22 EscharEx ® Well -
Slide 23: EscharEx vs. SANTYL Head-to-Head Data
1 . Post - hoc data from the ChronEx Phase 2 study 2 . Comparable incidence of adverse wound reactions identified 23 EscharEx ® vs. SANTYL ® Head - to - Head Data 1 Consistent results in pediatric Phase 3 study, EU Phase 3 study and post marketing data 2 Patient reported pain 2 Incidence of complete
Slide 24: EscharEx Planned Phase 3 Study in VLU Patients
Safety: Safety & tolerability | ECG | Change in pain | Wound infection rates | Immunogenicity Research collaborations with Solventum , Mölnlycke and MIMEDX 24 EscharEx ® Planned Phase 3 Study in VLU Patients STUDY OBJECTIVES To assess safety and efficacy of EscharEx compared to placebo in patients w
Slide 25: EscharEx Planned Phase 2/3 Study in DFU Patients
Safety: Safety & tolerability | ECG | Change in pain | Wound infection rates | Immunogenicity € 16.25 M funding from the European Innovation Council accelerator 25 EscharEx ® Planned Phase 2 / 3 Study in DFU Patients STUDY OBJECTIVES 1 To assess safety and efficacy of EscharEx compared to placebo in
Slide 26: EscharEx Combined VLU/DFU U.S. Market Opportunity
22 % 14 % 11 % 29 % 15 % 23 % 3 % 3 % 20 % 14 % 21 % 11 % 3 % 3 % 5 % 4 % Current Post-Product X Launch 1 . Oliver Wyman Primary research 26 EscharEx ® Combined VLU/DFU U.S. Market Opportunity 1 29 % 55 % Market Potential Growth EscharEx ® anticipated to draw market share from all other debridement
Slide 27: Highly Experienced Leadership Team
27 Highly Experienced Leadership Team Ofer Gonen CEO Dr. Ety Klinger Chief R&D Officer Nachum (Homi) Shamir Chairman Dr. Robert J. Snyder CMO Barry Wolfenson EVP Strategy & Corp Dev. Hani Luxenburg CFO Dr. Shmulik Hess COO & CCO
Slide 28: Strategic Timeline
NexoBrid ® FDA approved 28 Strategic Timeline 2027 - 8 2023 2024 2025 - 6 Interim assessment of EscharEx ® Phase EscharEx ® Phase results EscharEx ® VLU Phase initiation 6 X facility scale - up NexoBrid ® ~$ 24 M revenue $ 25 M PIPE Mölnlycke collaboration EscharEx ® approval $ 100 M+ revenue with c