Mediwound Ltd. · NASDAQ:MDWD
Mediwound — Investor Presentation (January 2024)
29 slides from Mediwound's investor presentation, Jan 8, 2024
Slide 1: Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair
January 2024 I Nasdaq: MDWD Next-Generation Enzymatic Therapeuticsfor 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 products
Slide 3: Company Highlights
3 Company Highlights Global strategic collaborations Solid balance sheet & strong investor base Validated enzymatic technology platform Diversified portfolio NexoBrid® - Eschar removal for burns EscharEx® - Debridement of wounds MW005 - Biotherapy for skin cancer 14 successful clinical trials 120+pe
Slide 4: Core Platform Enzymatic Technology
4 Core Platform Enzymatic Technology Pineapple stem harvest Protein extraction Purification, enrichment, stabilization Complex mixture of proteolytic enzymes Images modified from Labster theory and bioinfo Healthy skin Non-viable tissue is rapidly and effectively removed to obviate surgery Viable ti
Slide 5: Multi-billion Dollar Portfolio
5 Multi-billion Dollar Portfolio Indication: Eschar removal of deep partial and full thickness burns Classification: Orphan biological drug Target users: Hospitalized patients Development status: FDA/EU/JP approved NexoBrid® Disruptive therapy for burn care Indication: Debridement of chronic/ hard-t
Slide 6: Pipeline
6 Pipeline Debridement of VLU Debridement of DFU Debridement of post traumatic wounds P2 studies completed P2 study completed P3 initiation in 2H 2024 EscharEx® BCC (topical) MW005 P1/2 completed BCC & Tissue disorders (injectable) MW003 P1 ready Development Phase 1 Phase 2 Phase 3 Registration Mark
Slide 7: Value Creating Milestones
2024 2023 7 Value Creating Milestones Phase 1/2 positive results FDA approval Phase 2 positive results Protocols submissions Strategic research collaborations US pediatric label extension submission EU pediatric label extension approval US commercial launch StrategicBusiness Development Scale up fac
Slide 8: Financial Highlights
Financial Highlights 8 2023 revenues of $19MNexoBrid is profitable 2024 product revenuesexpected >40% growth Scale-up will increasegross margin >65% REVENUES MDWD SHAREHOLDERS2 MDWD ANALYSTS: Josh Jennings, MD - Cowen Francois Brisebois - Oppenheimer Jason McCarthy, PhD - Maxim Swayampakula Ramakant
Slide 9: NexoBrid Growth Supported by Manufacturing Facility Scale Up
9 NexoBrid® Growth Supported by Manufacturing Facility Scale Up Planning and Initiation 2023 2024 2025 Construction FDA/EMA Submissions 6X Capacity Increase Full manufacturing capacity in 2025 NexoBrid forecast revenues ($M) Global demand exceeds current manufacturing capacity 3-fold 1 Includes bind
Slide 10: NexoBrid: Non-surgical eschar removal for severe burns
Early, effective and selective non-surgical eschar removal for severe burns Approved in the U.S., EU, JP, IN; 14,000 patients treated globally to date Validated & commercialized (10% concentration)
Slide 11: Emerging SOC for Effective & Selective Eschar Removal
11 Emerging SOC for Effective & Selective Eschar Removal that Preserves Viable Tissue Eschar removal is the first critical step in burn care Loss of healthy tissue & blood Surgery is traumatic & non-selective1,2 Prevents local infection and sepsis Eschar Requires surgical team, operating room Challe
Slide 12: Disruptive Bioactive Therapy for Burn Care
12 Indicated for eschar removal of deep partial-thickness and/or full-thickness thermal burns Effectively removes eschar within 4 hours without harming viable tissue or blood loss Allows for early visual assessment of the wound Commercially available in US (Vericel), Japan (Kaken), India (BSV) and E
Slide 13: NexoBrid Phase Studies Demonstrate Superiority
13 NexoBrid® - Phase 3 Studies Demonstrate Superiority1 Consistent results in pediatric Phase 3 study, EU Phase 3 study and post marketing data2 Safe and well tolerated Improved scarring and comparable wound closure Incidence of complete eschar removal P<0.0001 Time to complete eschar removal(days)
Slide 14: NexoBrid Market & Commercialization
14 NexoBrid® - Market & Commercialization 1 Hirche et al., 2020; Burns 2 2017 National Burn Repository 3 ~90% of eligible patients require eschar removal 4 Shoham et al., 2023; IWJ Commercialization strategy 2M Annual burns 160K Hospitalized patients Estimated burn patients in key markets2 8% hospit
Slide 15: Next-Generation Enzymatic Debridement for Wound Care
Next-Generation Enzymatic Debridement for Wound Care Superior to SOC - Sets a new bar for efficacy De-risked: Based on a validated technology Targets $2B market opportunity (5% concentration)
Slide 16: Chronic Wound Debridement Approaches are Abundant but Sub-Optimal
Modalities by Efficacy and Convenience Modalities by Wound Type (U.S.)1 Efficacy Trained Specialist Untrained HCP/ Nurses Ultrasonic Hydrosurgery Biological Sharp Current Enzymatic Autolytic 29% 29% Legend 16 Chronic Wound Debridement Approaches are Abundant but Sub-Optimal 1 OW Primary Research Sur
Slide 17: EscharEx for chronic & hard-to-heal wounds
17 Targeted for rapid debridement and granulation tissue formation in chronic & hard-to-heal wounds Investigational drug containing a sterile mixture of proteolytic enzymes Debrides chronic wounds in 4-8 daily applications Promotes granulation tissue, and reduction of biofilm & bacterial load Next-G
Slide 18: EscharEx is Well-Positioned to Become Market Leader
18 EscharEx® is Well-Positioned to Become Market Leader Data from a head-to-head study anticipated in 1H 2024 1 OW Primary Research 2 Lantis JC and Gordon I., 2017; Wounds 3 Patry et al., 2017 4 Snyder et al., 2023; Wounds 5 SOC in the Phase 2 trial included SANTYL® 6 Based on the data to date 7 SAN
Slide 19: EscharEx Phase 2 Study Endpoints Significantly Met
19 No safety issues; Efficacy consistent with previous Phase 2 studies EscharEx® Phase 2 Study – Endpoints Significantly Met Primary Endpoint Incidence of complete debridement EscharEx: 63% vs NSSOC: 13% EscharEx® Gel Vehicle n = 46 n = 43 P = 0.004 P = 0.001 Time to complete debridement: EscharEx:
Slide 20: EscharEx Rapid Wound Bed Preparation
20 EscharEx® Phase 2 Study – Rapid Wound Bed Preparation Time to WBP Subjects reaching WBP are 4.1X more likely to achieve wound closure (p = 0.0004) Significant correlation -WBP vs. time to wound closure. HR of 11.96 (p < 0.0001) Faster wound bed preparation Increased probability of wound closure
Slide 21: EscharEx Phase 2 Pharmacology Results: Fast, Safe, Effective
21 Beyond traditional debridement: reduction in wound size, biofilm and bacterial burden EscharEx® Phase 2 Pharmacology Results: Fast, Safe, Effective1 64% 35% 100% Bioburden reduced by end of treatment Wound size reduced by end of two-week follow-up Biofilm substantially reduced for all patients po
Slide 22: EscharEx Phase 3 Study in VLU Patients
22 EscharEx® Phase 3 Study in VLU Patients STUDY OBJECTIVES To assess safety and efficacy of EscharEx compared to placebo in VLUs A global (USA, EU, ROW)1, randomized, double blind, adaptive design study in patients with VLUs Two arms: EscharEx vs. placebo, 1:1 ratio Sample size: 216 VLU patients Tr
Slide 23: EscharEx U.S. Market Opportunity
23 1 OW Primary Research 29% 55% Market potential growth EscharEx® anticipated to draw market share from all other debridement modalities 2.1M patients VLU: 1.0M | DFU: 1.1M 400K patients 1.3M patients VLU: 560K DFU: 770K Epidemiology Estimate TAM - $2B 30% expected market share 55-70% eligible debr
Slide 24: An Established Market With Strong Pricing Capability
24 1 OW Primary Research An Established Market With Strong Pricing Capability1 Site of care: Hospital-based outpatient department Wound care clinics Skilled nursing facilities Home care Key clinicians: Vascular specialists Plastic surgeons Podiatrists Primary care physicians Current enzymatic debrid
Slide 25: MW005: Novel biotherapy for Non-Melanoma Skin Cancer
Novel biotherapy for Non-Melanoma Skin Cancer MW005 Effective and safe topical application BCC is the most frequently diagnosed skin cancer in the U.S. (5% concentration)
Slide 26: Novel Biotherapy for Non-Melanoma Skin Cancer
26 Novel Biotherapy forNon-Melanoma Skin Cancer MW005 Before After The Market 4.3M of BCC cases diagnosed in the US annually Surgery is the SOC; topical products have high AEs & recurrence rates SOC requires a 6-weeks treatment MW005 Investigational drug containing a sterile mixture of proteolytic e
Slide 27: MW005 Phase 1/2 Studies
MW005 27 MW005 is safe and well-tolerated; complete clinical clearance of target lesions within 2 weeks (vs. 6+ weeks for standard BCC topicals) 1 Rosenberg et al 2021; The Open Dermatology Journal 15-39 Study Subject Applications Clinical Assessment No Recurrence Period Phase 1/2 (POC)1 N = 7 4 sup
Slide 28: Leadership Team
28 Leadership Team Nachum (Homi) Shamir Chairman Ofer Gonen CEO Dr. Ety Klinger Chief R&D Officer Dr. Shmulik Hess COO & CCO Hani Luxenburg CFO Dr. Robert J. Snyder CMO Barry Wolfenson EVP Strategy & Corp Dev.
Slide 29: Strategic Timeline
NexoBrid® FDA approved 29 2023 2024 2025 2026-7 Interim assessment of EscharEx® Phase 3 Strategic Timeline EscharEx® Phase 2 results EscharEx® Phase 3 initiation 6X facility scale up $27.5M financing NexoBrid® >$24M revenues BARDA/DoD collaborations EscharEx® approval >$100M revenues with contributi