Mediwound Ltd. · NASDAQ:MDWD
Mediwound — Investor Presentation (January 2023)
20 slides from Mediwound's investor presentation, Jan 9, 2023
Slide 1: Non-Surgical Biological Solutions for Tissue Repair & Regeneration
January 2023 I Nasdaq: MDWD Non-Surgical Biological Solutions for Tissue Repair & Regeneration
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 collaborations cGMP certified sterile manufacturing facility Solid balance sheet & strong investor base NexoBrid® - 2022 revenues: $26-27M EscharEx® - $2B* opportunity Validated enzymatic technology platform FDA/EMA/PMDA approvals 14 succes
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 Boaz Gur-Lavie Chief Financial Officer Dr. Robert J. Snyder Chief Medical Officer Prof. Lior Rosenberg Founder, Medical Director
Slide 5: Proprietary Enzymatic Technology Platform
5 Proprietary Enzymatic Technology Platform 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 target only non-viable tissue Viable tissue
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: Upcoming Milestones
7 Upcoming Milestones 2023 Phase I/II results MW005 Phase I/II data 2024 NexoBrid® EU Pediatric label extension approval FDA approval FDA Pediatric label extension submission Marketing approval in JP/ IN US commercial launch Meetings with FDA EscharEx® CHMP Scientific advice Phase III initiation Pha
Slide 8: Financial Highlights
Financial Highlights 8 * Cash, cash equivalents and short-term bank deposits; cash amount takes into account the receipt of $7.5M milestone from Vericel upon BLA approval $42M in cash* as of December 31, 2022 Cash runway - through 2025 Strong investor base BALANCE SHEET 2022 revenues of ~$26-27M Nex
Slide 9: Early, effective and selective non-surgical eschar removal for severe burns
Early, effective and selective non-surgical eschar removal for severe burns Globally approved: FDA, EU, JP, IN; 11,000 patients Validated & commercialized
Slide 10: Clear Unmet Need for Early, Effective and Selective Non-Surgical Eschar Removal in Severe Burns
10 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 11: Disruptive Bioactive Therapy for Burn Care
11 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 12: NexoBrid - Phase III Studies Demonstrate Superiority
12 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 13: 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 14: 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 Versajet Biological Sharp Enzymatic Autolytic 29% 29% Legend 14 Approaches in Chronic Wound Debridement are abundant but sub-optimal *Source: OW Primary Research (6/20
Slide 15: EscharEx: Debridement of chronic and hard-to-heal wounds
15 Indicated for 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 a Week Inline with current treatment workflo
Slide 16: EscharEx Phase II Studies - Highly Efficacious vs. SOC
16 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 17: EscharEx U.S. Market Opportunity
17 *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 18: 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 diagnosed skin cancer in the US
Slide 19: Novel Biotherapy for Non-Melanoma Skin Cancer MW005
19 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 20: Why MediWound?
$26-27M revenues mainly from non-products NexoBrid® FDA approved $42M in cash* Robust EscharEx® Phase II results 20 Why MediWound? 2022 2023 2025 2026 EscharEx® Phase III initiation Scale-up manufacturing facility NexoBrid® Product revenue growth >75% $40-50M Revenues from products Additional revenu