MediWound (MDWD) TD Cowen 46th Annual Health Care Conference summary

Key product updates and clinical development

• NexoBrid is commercialized for severe burns with a $300 million U.S. TAM and is distributed via a partnership; EscharEx, targeting chronic wounds, addresses a much larger market of 4 million cases annually in the U.S.

• EscharEx is in phase III for venous leg ulcers, with phase II for diabetic foot ulcers and a small investigator-led study for pressure ulcers starting this year.

• NexoBrid manufacturing capacity is being expanded 6X, with EMA inspection expected mid-2026 and FDA inspection by late 2024 or 2025.

• EscharEx phase III interim assessment is planned for end of this year, with last patient out in 2027 and potential approval by end of 2028.

• Both products use a proteolytic enzyme suite derived from pineapples, with strong clinical validation and global collaborators.

Market opportunity and competitive landscape

• Chronic wounds represent a $2.5 billion TAM in the U.S., with EscharEx projected to reach $831 million in peak sales for venous leg and diabetic foot ulcers.

• SANTYL, the main competitor, achieves debridement in 4–8+ weeks, while EscharEx achieves it in 4–14 days, offering a significant clinical advantage.

• EscharEx aims to expand the enzymatic debridement market share from 18% to 30%, capturing about 22.5% of that segment.

• Pricing for EscharEx is benchmarked against SANTYL, with payers indicating a 15–50% premium is feasible.

• Additional upside exists if pressure ulcers are included and if higher pricing is achieved based on health economic outcomes.

Financial outlook and strategic milestones

• 2024 revenue is projected at $24–26 million, rising to $32–35 million in 2025, with growth driven by NexoBrid sales and consistent government funding.

• Manufacturing expansion will enable global sales, including to governments for military and mass casualty preparedness.

• EscharEx approval and launch are expected to contribute to revenue from 2028 onward.

• Current cash position is $54 million, with NexoBrid already profitable on its own.

• Initial manufacturing capacity is sufficient for early launches, with plans to expand further, potentially including a U.S. facility.