MediWound (MDWD) investor relations material

Strategic overview and product pipeline

• Focus on two main products: NexoBrid for severe burns and EscharEx for chronic wounds, both based on a validated enzymatic platform with regulatory approvals in major markets.

• NexoBrid is commercially available and generating revenue, with growing adoption in U.S. burn centers and a 10-year BARDA contract.

• EscharEx is in a global phase III VALUE trial for venous leg ulcers, targeting 216 patients across 40 sites, with interim and final data expected by early 2027.

• Additional pipeline includes a phase II study for diabetic foot ulcers and ongoing expansion of manufacturing capacity to meet rising demand.

• The company is not considered a scientific risk due to extensive clinical validation and regulatory approvals.

Clinical development and catalysts

• The VALUE phase III trial is the largest wound care study in two decades, with robust design and high probability of success; interim analysis will assess if sample size adjustments are needed.

• Top-line results are expected three months after recruitment completion, with the main catalyst anticipated at the end of Q1 2027.

• Phase II data showed EscharEx achieved 63% complete debridement in two weeks versus 30% for placebo, but only a marginal advantage over placebo is needed for phase III success.

• Expansion into additional indications like diabetic foot and pressure ulcers is planned to coincide with VALUE trial readout.

• Manufacturing facility upgrades are on track, with European approval expected by mid-2027, enabling increased production.

Competitive landscape and commercial outlook

• SANTYL, the main competitor, is seen as slow and less effective, with EscharEx offering significantly faster debridement (4-5 days vs. 4-8 weeks).

• Smith & Nephew's efforts to develop a second-generation product are not viewed as an immediate threat, with any potential competition likely a decade away.

• NexoBrid's adoption in U.S. burn centers is gradual due to protocol changes, but usage is expected to increase as manufacturing capacity expands.

• The BARDA contract provides stable revenue streams, with the majority of funds allocated to Vericel but significant procurement from the company.

• U.S. government plans for a domestic manufacturing facility will not impact short-term revenue, as current capacity is sufficient for global demand.