Mediwound Ltd. · NASDAQ:MDWD
Mediwound — Investor Presentation (May 2023)
22 slides from Mediwound's investor presentation, May 31, 2023
Slide 1: Next-Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair
May 2023 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 Diversified portfolio Global strategic partnerships cGMP certified sterile manufacturing facility Solid balance sheet & strong investor base NexoBrid® - 2022 revenues: $26.5M EscharEx® - $2B* opportunity Validated enzymatic technology platform FDA/EMA/PMDA approvals 14 successfu
Slide 4: Leadership Team
4 Leadership Team Nachum (Homi) Shamir Chairman of the Board Ofer Gonen Chief Executive Officer Dr. Ety Klinger Chief R&D Officer Tzvi Palash Chief Operating Officer Hani Luxenburg Chief Financial Officer Dr. Robert J. Snyder Chief Medical Officer Barry Wolfenson EVP Strategy & Corp Dev.
Slide 5: Clinically and Commercially Validated Protein-Based Therapies
5 Clinically and Commercially Validated Protein-Based Therapies Pineapple stem harvest Protein extraction Purification, enrichment, stabilization Complex mixture of proteolytic enzymes Images modified from Labster theory and bioinfo Healthy skin Damaged skin Selective enzymes quickly target only non
Slide 6: Multibillion Dollar Portfolio
6 Multibillion Dollar Portfolio Indication: Eschar removal of deep partial and full thickness burns Classification: Orphan biological drug Target users: Hospitalized patients Substantial U.S. government support Development status: FDA/EU/JP approved NexoBrid® Disruptive therapy for burn care Indicat
Slide 7: Pipeline Development
Burn eschar removal in adults Pediatric indication for burns Expanded access protocol Sulfur mustard injuries Battlefield treatment Debridement of VLUs Debridement of VLU/DFU/post-op Pharmacology study VLU/DFU BCC (topical) Tissue disorders (injectable) 7 Pipeline Development Phase I Phase II Phase
Slide 8: Upcoming Milestones
8 Upcoming Milestones 2023 Phase I/II results MW005 Phase I/II data 2024 NexoBrid® US commercial launch FDA approval FDA pediatric label extension submission Marketing approval in JP/IN EU pediatric label extension approval Meetings with FDA EscharEx® CHMP scientific advice Phase III initiation Phas
Slide 9: Financial Highlights
Financial Highlights 9 * Cash, cash equivalents and short-term bank deposits $57M in cash* as of December 31, 2022 Cash runway - through profitability High quality investor base BALANCE SHEET 2022 revenues of ~$26.5M NexoBrid is profitable 2023 Product revenues >30% growth 2023 Product gross margin
Slide 10: Early, effective and selective 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; 12,000 patients treated globally to date Validated & commercialized
Slide 11: Clear Unmet Need for Early, Effective and Selective Non-Surgical Eschar Removal in Severe Burns
11 Clear Unmet Need for Early, Effective and Selective Non-Surgical Eschar Removal in Severe Burns Eschar removal is the 1st critical step in burn care Loss of healthy tissue & blood Current practice* is traumatic & non-selective Prevents local infection and sepsis Eschar Requires surgical team, ope
Slide 12: NexoBrid: Disruptive Bioactive Therapy for Burn Care
12 Indicated for eschar removal of deep-partial & full-thickness thermal burns A sterile mixture of proteolytic enzymes Effectively removes eschar within 4 hours without harming viable tissue or blood loss Allows for early visual assessment of the wound Before After Disruptive Bioactive Therapy for
Slide 13: NexoBrid - Phase III Studies Demonstrate Superiority
13 NexoBrid® - Phase III Studies Demonstrate Superiority Incidence of complete eschar removal P<0.0001 Time to complete eschar removal P<0.0001 NexoBrid N=75 SOC N=75 1.0 0.5 0.0 0 10 20 30 40 Incidence of surgical eschar removal P <0.0001 Blood loss P<0.0001 NexoBrid® SOC SOC® NexoBrid® SOC NexoBri
Slide 14: 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
Slide 15: Approaches in Chronic Wound Debridement are abundant but sub-optimal
Modalities by Efficacy and Convenience Modalities by Wound Type (U.S.)* Efficacy Trained Specialist Untrained HCP/ Nurses Ultrasonic Hydrosurgery Biological Sharp Enzymatic Autolytic 29% 29% Legend 15 Approaches in Chronic Wound Debridement are abundant but sub-optimal *Source: OW Primary Research (
Slide 16: Targeting debridement of chronic and hard-to-heal wounds
16 Targeting debridement of chronic and hard-to-heal wounds Investigational drug containing a sterile mixture of proteolytic enzymes Debrides chronic wounds in 4-6 daily applications Next-Generation Enzymatic Debridement - Wound Bed Preparation within Days Inline with current treatment workflows and
Slide 17: EscharEx Phase II Studies - High Efficacy vs. SOC
17 Average # of applications Time to complete debridement EscharEx - 9 days vs. NSSOC - 59 days P<0.001 P = 0.016 # of Days EscharEx NSSOC % of subjects Incidence of complete debridement EscharEx vs. Non-Surgical SOC Incidence of complete debridement P <0.001 No safety issues | Consistent with two a
Slide 18: EscharEx U.S. Market Opportunity
18 *Source: OW Primary Research (6/2022) 29% 55% Market potential growth EscharEx® anticipated to draw share from all other debridement modalities 2.1M patients VLU: 1.0M | DFU: 1.1M 400K patients 1.3M patients VLU: 560K DFU: 770K 2022 Epidemiology Estimate TAM - $2B 30% expected market share 70% el
Slide 19: EscharEx Phase III Study in VLU Patients
19 EscharEx® Phase III Study in VLU Patients STUDY OBJECTIVES To assess safety and efficacy of EscharEx compared to Gel Vehicle in VLUs A global (USA, EU, Israel), randomized, double blind, adaptive design study in patients with VLUs Two arms: EscharEx vs. Gel Vehicle, 1:1 ratio Sample size: 244 VLU
Slide 20: Novel biotherapy for Non-Melanoma Skin Cancer MW005
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.
Slide 21: Novel Biotherapy for Non-Melanoma Skin Cancer MW005
21 Novel Biotherapy for Non-Melanoma Skin Cancer MW005 Before After The Market 4.3M annual cases of Basal Cell Carcinomas diagnosed in the US Surgery is the SOC; topical products have high AEs & recurrence rates The Product Investigational drug containing a sterile mixture of proteolytic enzymes Eas
Slide 22: Investment Highlights
$26.5M revenues mainly from non-products NexoBrid® FDA approved Robust EscharEx® Phase II results $42M in cash 22 Investment Highlights 2022 2023 2024-5 2026-7 $27.5M financing EscharEx® Phase III initiation Scale-up manufacturing facility NexoBrid® Product revenue growth >30% MW005 Phase I/II resul