Slide 1: Company Presentation: MediWound Innovative solutions for wound & burn care
Company Presentation MediWound Innovative solutions for wound & burn care Nasdaq: MDWD Gal Cohen, President & CEO
Slide 2: Forward-looking statements
§ This presentation contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. W
Slide 3: Fully integrated biopharmaceutical company for wound and burn care
§ Fully integrated, biopharmaceutical company developing, manufacturing and commercializing novel products for wound and burn care management § Strong proprietary proteolytic enzymes technology: § NexoBrid®: severe burn wounds § Launched, innovative, orphan, biological drug indicated for eschar remo
Slide 4: Product pipeline
Pre-clinical Phase 1 Phase 2 Phase 3 Approved Product Indication NexoBrid Severe burns EscharEx Chronic wounds MWPC003 Connective tissue disorders US Phase 3 study 2nd Phase 2 study Ex-vivo results Launched in Europe EU Paediatric study
Slide 5: Addressable patient populations
§ ~200,000 hospitalized patients every year in EU and US § Prevalence higher in emerging economies (e.g. 400,000 patients every year in India) § Broad addressable population of more than 14 million patients in US and EU § Includes patients with diabetic/pressure/ venous ulcers and post-surgery/ trau
Slide 6: Importance of eschar removal
Before… Eschar Subcutaneous fat Dermis § Prevents local infection and sepsis § Avoids further deterioration and scarring § Enables initiation of wound healing § Allows direct visual assessment of wound bed enabling precise diagnosis of wound severity and an informed treatment plan
Slide 7: Limitations of current eschar removal methods
Surgical eschar removal § Tangential excision § Dermabrasion § Hydro-jet surgery Significant limitations § Traumatic § Challenging in delicate areas and patients § Non-selective § Donor sites sacrifice discomfort and long-term sequelae § Delayed start of debridement (diagnosis dependent) Non-surgica
Slide 8: NexoBrid biological drug for eschar removal
§ Biological drug containing a sterile mixture of proteolytic enzymes § Easy to use, single, non-surgical topical application at the patient’s bedside § Effectively removes the burn eschar within 4 hours without harming surrounding viable tissue § Allows the physician to visually assess the wound an
Slide 9: Before and after NexoBrid treatment
Intact skin preserved Non-injured dermis preserved Before After
Slide 10: Clinical studies completed with NexoBrid
§ Six Phase 2 and Phase 3 clinical studies completed, assessing safety and efficacy of NexoBrid § Investigated in more than 550 hospitalized burn patients § Sites across 15 countries and 4 continents § Investigated by ~100 leading burn specialists and KOLs § EU Phase 3 trial was completed early, aft
Slide 11: Reduced excision and autografting incidence
-> Less autografting provides additional benefits including less surgery, donor site morbidity and permanent scarring P value < 0.0001 Incidence of excision (all wounds-ITT) P value < 0.0001 P value = 0.0055
Slide 12: Long-term scar outcomes
Outcome NexoBrid SOC Comments All wounds Modified Vancouver Scar Scale (per wound) 3.12 (113) 3.38 (78) Donor site scars Incidence (per patient) 40% (22 / 54) 68% (24 / 35) P-value = 0.01 Area % TBSA (per patient) 5.8% (22) 8.3% (24) 30% smaller scars Modified Vancouver Scar Scale (per wound) 0.75 (
Slide 13: NexoBrid versus standard of care
Standard of Care Important Elements NexoBrid* Surgical Non-Surgical Time to Start Debridement Rapid Debridement Time to Complete Debridement Diagnosis-Fast/Effective/Selective Less Traumatic/Surgeries Spare Viable Tissue Reduced Area for Grafting (Minimal Invasive Modality) Less Procedural Blood Los
Slide 14: European launch and market access
NO SE FI ES FR IT PL DE CZ RO HU SK AT UK IE PT EE LV LT BG GR IS Global - marketing strategy and tools are ready to support our local sales force and go to market EU - launch through wholly owned local subsidiary ▪ Recruited nearly all the team across EU (~25 FTE’s) ▪ Launched NexoBrid in all targe
Slide 15: Interest, workflow assimilation, reimbursement
Interest Work flow assimilation Reimbursement
Slide 16: Targeting burn centers and hospital burn units
§ Targeting specialist call point at burn centers and hospital burn units § Smaller hospitals are expected to follow the trend c. 120 Burn centers c. 360 Large hospitals Other hospitals
Slide 17: Burn centers trained and treating
c. 120 Burn centers # of BC’s § Trained : ~ 60% of target burn centers throughout Europe § Treating : ~ 60% of trained centers § Patients treated in 2015 > 2014 total
Slide 18: Sales and patients treated
Sales (€) Patients treated Burn center (Berlin, Germany) Sales linear trend-line
Slide 19: US Phase 3 study design and timelines
§ Prospective § Randomized § Controlled: NexoBrid vs. Vehicle vs. Standard of care - 3:1:3 § Masked § Multi-Center : ~ 30 centers in US, EU and IL § Follow up: 12 & 24 months § Sample size: 175 patients § Primary: Incidence of eschar removal vs. vehicle § Secondary: Surgical burden, earlier eschar r
Slide 20: Chronic wounds opportunity
Venous Leg Ulcers Pressure Ulcers Surgical/ Traumatic Wounds Diabetic Foot Ulcers 5% of diabetics or ~ 1.3 M people develop DFUs annually Millions receive post-surgical wound care in US annually Affecting ~ 600,000 people in the US annually 2.5 M pressure ulcers treated in the US in acute care facil
Slide 21: DFU and VLU market potential
Incidence of DFUs* Incidence of VLUs* ~70% undergo debridement ~55% undergo debridement Over $1B market potential in DFU’s and VLU’s in the US alone
Slide 22: EscharEx Phase 2 study summary
2 nd Phase 2 Phase 3 Study Design Endpoints Study Timelines § Prospective § Randomized § Controlled (EscharEx vs. Gel) § Multi-Center § Sample size: 72 patients § Indications: Hard to heal VLUs, DFUs and post surgical § Eschar removal § Wound closure § Initiation: 2H/14 § Top-line results: 2H/15 § F
Slide 23: Financial summary and capital structure
($ in millions) 3 months ended March 31, 2015 Revenues 0.1 Gross loss 0.1 Research and development, net 1.4 Selling, general and administrative 3.0 Operating loss 4.5 ($ in millions) As of March 31, 2015 Cash, cash equivalents and short term cash deposits 59.4 Working capital 59.6 Total assets 65.6
Slide 24: Milestones 2014-2015
2014 2015 Completed IPO; $71.7M net proceeds Establishment of a full commercial organization in EU Launched NexoBrid in all key EU target markets (except FR & CZ) and in Israel Signed distribution agreements in LATAM, CIS, Asia-Pacific markets Started EscharEx Phase II study Started NexoBrid Pediatr
Slide 25: Investment highlights
New paradigm in eschar removal § Easy to use, non-surgical, single application with significant advantages over SOC § Approved and launched in Europe Attractive target markets § Hospitalized burn patients - orphan indication, focused target audience of burn specialists § Chronic wounds - significant
Slide 26: Thank you
Thank you MediWound Innovative solutions for wound & burn care