Next-Generation Enzymatic Therapeutics for Non-SurgicalTissue Repair
December 2023 I Nasdaq: MDWD
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, 2022, filed with the Securities and Exchange Commission ("SEC") on March 16, 2023, 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.
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Company Highlights
Validated enzymatic | Diversified | cGMP certified sterile | |||
technology platform | portfolio | manufacturing facility | |||
FDA/EMA/PMDA approvals | NexoBrid® - 2022 revenues: $26.5M | Scale up program to provide | |||
14 successful clinical trials | EscharEx® - $2B* opportunity | 6X capacity by 2025 | |||
120+peer reviewed publications | MW005 - Phase I/II for BCC | Supports growing global demand | |||
Global strategic | Solid balance sheet |
collaborations | & strong investor base |
Vericel, Kaken, 3M, Mölnlycke, | Cash of $46M** | |
MIMEDX, BARDA, DoD, PMI, BSV | Runway through profitability | |
*TAM - targeted addressable market; Source: Oliver Wyman market research | 3 | ||
**As of September 30, 2023. | |||
Leadership Team
Nachum (Homi) Shamir | Ofer Gonen | Barry Wolfenson | Dr. Ety Klinger | Dr. Shmulik Hess | Hani Luxenburg | Dr. Robert J. Snyder |
Chairman | CEO | EVP Strategy & Corp Dev. | Chief R&D Officer | COO & CCO | CFO | CMO |
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Clinically and Commercially Validated Protein-Based Therapies
Proprietary IP protected manufacturing process
Pineapple stem | Protein | |
harvest | extraction | |
Purification, enrichment, | Complex mixture of | |
stabilization | proteolytic enzymes | |
Images modified from Labster theory and bioinfo
Utilizing the same core biotherapeutic enzymatic platform technology
Complex mixture of enzymes
Healthy skin
Damaged skin
Viable tissues preserved; healing begins
Non-viable tissue is rapidly and effectively
removed to potentially avoid surgery
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Multibillion Dollar Portfolio
NexoBrid® | EscharEx® | ||
Disruptive therapy for burn care | Next-gen enzymatic therapy for wound care** | ||
Indication: Eschar removal of deep partial | Indication: Debridement of chronic/ | ||
and full thickness burns | hard-to-heal wounds | ||
Classification: Orphan biological drug | Classification: Biological drug | ||
Target users: Hospitalized patients | Target users: Optimized for outpatient setting | ||
Development status: FDA/EU/JP approved | Development status: Phase III initiation 2H 2024 |
TAM* (U.S.): >$300M | TAM* (U.S.): >$2B |
*TAM - targeted addressable market; Source: Oliver Wyman market research. **Investigational drug.
MW005
Biotherapy for non-melanoma skin cancers**
Indication: Treatment of non-melanoma skin cancers
Classification: Biological drug
Target users: Optimized for outpatient setting
Development status: Phase I/II
TAM* (U.S.): >$1B
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Pipeline
Indication
Development
Phase I
Phase II
Phase III
Registration
Market
Burn eschar removal in adults | Approved | |||||||
Pediatric indication | EMA approved; | submitted to | FDA | |||||
Sulfur mustard injuries | BARDA funded | |||||||
Battlefield treatment | DoD funded | |||||||
EscharEx® | Debridement of VLUs | P3 initiation in 2H 2024 | ||||||
Debridement of VLU/ DFU/ post-op | P2 study completed | |||||||
Pharmacology study VLU/ DFU | P2 study completed | |||||||
MW005 | BCC (topical) | P1/2 completed | ||||||
MW003 | BCC & Tissue disorders (injectable) | P1 ready | ||||||
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Scaling Up the cGMP Manufacturing Facility to Support Growth
2023 | 2024 | 2025 |
Planning and Initiation
Construction
FDA/EMA Submissions
6X Capacity Increase
$8M | $15M | $50M |
R e v e n u e c a p a c i t y |
Continuous manufacturing of NexoBrid to meet the rising global need.
Anticipated completion by mid-2024; full manufacturing capacity in 2025
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Value Creating Milestones
NexoBrid®
EscharEx®
2 0 2 3 | 2 0 2 4 | ||||||||||||||
FDA | JP commercial | EU pediatric label | IN commercial | Capacity | |||||||||||
approval | launch | extension approval | launch | increase | |||||||||||
US commercial | US pediatric | Scale up facility | US pediatric | ||||||||||||
launch | label extension | completion | label extension | ||||||||||||
submission | approval | ||||||||||||||
Phase II | CHMP scientific | Protocols | Phase III | ||
positive results | advice | submissions | initiation | ||
MW005
FDA feedback on Phase III protocol
Strategic research collaborations
Phase I/II positive results
PK study initiation
Strategic
Business Development
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Financial Highlights
BALANCE SHEET | REVENUES | COMMERCIALIZATION | ||||||
$46M in cash* | 2022 revenues of $26.5M | Global expansion via strategic | ||||||
as of September 30, 2023 | NexoBrid is profitable | collaborations (Vericel, Kaken, BSV, PMI) | ||||||
Cash runway - through profitability | 2024 product revenues | Up to $216M support by BARDA | ||||||
High quality investor base | >30% growth | EU direct sales force; focus on EU-5 | ||||||
Scale-up will drive increase | (CAGR >20%) | |||||||
in gross margin |
ANALYSTS: | • | Josh Jennings, MD, Cowen | • | Swayampakula Ramakanth, PhD, HCW |
• | Francois Brisebois, Oppenheimer | • | David Bouchey, Aegis | |
• Jason McCarthy, Ph.D, Maxim
* Cash, cash equivalents and short-term bank deposits
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MediWound Ltd. published this content on 18 December 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 December 2023 13:46:05 UTC.