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- 16 Mar 23 MediWound Announces the Appointment of Hani Luxenburg as Chief Financial Officer
- 13 Feb 23 Current report (foreign)
- 7 Feb 23 Current report (foreign)
- 9 Jan 23 Current report (foreign)
- 29 Dec 22 MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
- 23 Dec 22 Current report (foreign)
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Exhibit 99.1
January 2023 I Nasdaq: MDWD Non-Surgical Biological Solutions for Tissue Repair & Regeneration
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 and product candidates, the anticipated development progress of our products and product candidates, and our expected cash runaway. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Important factors that could cause such differences include, but are not limited to the uncertain, lengthy and expensive nature of the product development process; market acceptance of our products and product candidates; the timing and conduct of our studies of our product candidates; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; our ability to maintain adequate protection of our intellectual property; competition risks; and the need for additional financing. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law Certain studies and data presented herein have been conducted for us by other entities as indicated where relevant. Intellectual property, including patents, copyrights or trade secret displayed in this presentation, whether registered or unregistered, are the intellectual property rights of MediWound. MediWound's name and logo and other MediWound product names, slogans and logos referenced in this presentation are trademarks of MediWound Ltd. and/or its subsidiaries, registered in the U.S.A., EU member states and Israel. NexoBrid development has been supported in part with federal funding from U.S. Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract numbers HHSO100201500035C and HHSO100201800023C. Contract number HHSO100201500035C provides funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States. We maintain our books and records in U.S. dollars and report under IFRS.
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 successful clinical trials 120+peer reviewed publications Provides capacity to scale revenue growth BARDA, Vericel, DoD (US), Kaken (JP), BSV (IN) $42M cash Runway through 2025 *TAM - targeted addressable market; Source: Oliver Wyman market research
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
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 tissues preserved; healing begins Clinically and commercially validated protein-based therapies
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 Indication: Debridement of chronic / hard-to-heal wounds Classification: Biological drug Optimized for outpatient setting Development status: Phase III ready EscharEx® Next-gen enzymatic therapy for wound care** Indication: Treatment of non-melanoma skin cancers Classification: Biological drug Optimized for outpatient setting Development status: Phase I/II MW005 Biotherapy for non-melanoma skin cancers** Pipeline Commercial *TAM - targeted addressable market; Source: Oliver Wyman market research **Investigational drug TAM* (U.S.): >$2B >$200M TAM* (U.S.): >$1B TAM* (U.S.): Pipeline
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 Phase II results JP commercial launch
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 NexoBrid is profitable 2023 Product revenues >75% growth 2023 Product gross margin >50%; scale-up drives further increase REVENUES Global expansion via strategic collaborations (Vericel, Kaken, BSV, GAG) Up to $211M support by BARDA EU direct sales force (CAGR >20%) COMMERCIALIZATION MDWD ANALYSTS: Josh Jennings, MD, Cowen Jacob Hughes, Wells Fargo Francois Brisebois, Oppenheimer Swayampakula Ramakanth, PhD, HCW David Bouchey, Aegis Jason McCarthy, Ph.D, Maxim
Early, effective and selective non-surgical eschar removal for severe burns Globally approved: FDA, EU, JP, IN; 11,000 patients Validated & commercialized
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, operating room Challenging in delicate areas Avoids further deterioration and scarring Enables initiation of wound healing Allows visual assessment of wound bed *current non-surgical eschar removal has limited efficacy, and requires multiple dressing changes
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 Burn Care Significantly reduces need for surgery & improves patient outcomes Easy-to-use, topical application at patient’s bedside
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 NexoBrid® Gel Vehicle [N=175] [N=175] [N=175] [N=175] Consistent with EU Phase III study & pediatrics Phase III study No safety issues after 24 month follow-up Non-inferiority in time to complete wound closure & scarring NexoBrid® SOC 815ml 14ml
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
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 (6/2022) | VLU – Venus Leg Ulcers | DFU – Diabetic Foot Ulcer
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 workflows and reimbursement landscape Easy to use, daily topical application for outpatient setting Extended IP protection *Investigational Drug, not approved in any jurisdiction *Investigational Drug, not approved in any jurisdiction VLU Before After Before After DFU ®
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 additional phase II studies Current enzymatic treatment has limited efficacy and is slow acting EscharEx® Phase II Studies - Highly Efficacy vs. SOC Primary Endpoint P = 0.004 EscharEx® Gel Vehicle EscharEx® NSSOC EscharEx® NSSOC N = 46 N = 43 N = 46 N = 30 N = 29 N = 21
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 - $2B 30% expected market share 70% eligible debridement EscharEx® U.S. Market Opportunity Cost of treatment: 1,500-1,800$*
Novel biotherapy for Non-Melanoma Skin Cancer MW005 Effective and safe topical application BCC is the most diagnosed skin cancer in the US
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 Easy to use, high potency, 5-7 topical applications US Phase I/II study, demonstrated efficacy, safety and tolerability MW005
$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 revenues (BARDA, DoD) Gross Margin >60% EscharEx® approval Cashflow positive >$100M Revenues with contribution from EscharEx® * Cash amount takes into account the receipt of $7.5M milestone from Vericel upon BLA approval