MediWound Q2 FY26 earnings call MDWD

The EscharEx global Phase III VLU trial (VALU study) remains the top priority, actively enrolling 216 patients across approximately 40 sites in the U.S., Europe, and Israel. Key milestones, including a prespecified interim sample size reassessment and completion of enrollment, are expected by the end of Q1 2027. An updated U.S. market assessment, expanded to include pressure ulcers, now estimates annual peak sales at $1.05 billion, strengthening the view of a substantial market opportunity. An investigator-initiated study for pressure ulcers is set to begin in Q4 2026, and a Phase II DFU study is planned for Q4 2026, enrolling 50 patients.

NexoBrid achieved its strongest quarter since launch, with record quarterly revenue, hospital unit sales, and ordering centers, reflecting continued adoption across approximately 80 U.S. burn centers. A new Master Service Agreement (MSA) with Vericel, following its $197 million BARDA contract, is expected to generate revenue for MediWound in H2 2026 through development initiatives, including a next-generation program for blast and friction-related injuries. The company is also advancing a room temperature stable formulation for battlefield burn care, supported by $18.3 million in nondilutive funding from the Department of War.

MediWound is implementing modifications requested by the EMA for its expanded NexoBrid manufacturing facility, with completion expected in Q4 2026. Commercial supply from this facility is anticipated in H2 2027, following regulatory approval. Management clarified that the facility timeline is not expected to materially impact 2026 revenue guidance, as a significant portion of H2 revenue is tied to government-funded development and existing agreements, rather than new commercial supply from the expanded facility.

Q2 FY26 revenue was $3.1 million, down from $5.7 million YoY, primarily due to the timing of^📎 BARDA-funded development revenue. Gross margin decreased to 10.9% from 23.5% YoY, impacted by facility scale-up. R&D expenses rose to $5.9 million, reflecting increased investment in the EscharEx VLU trial. Cash, cash equivalents, and deposits stood at $36 million as of June 2026, down from $54 million at year-end 2025, with a cash burn of $20 million in H1 FY26. Warrants and option exercises generated $0.8 million in H1, with an additional $1.1 million post-quarter end.

Management addressed comments from Smith & Nephew regarding a second-generation SANTYL product, noting that SANTYL is slow and not a fast debridement option. They believe EscharEx, with its ability to achieve complete debridement within four to five days, greatly expands the market by fitting better into wound clinic workflows and taking share from other modalities. Regarding the CPT code for NexoBrid, there is no publicly available information on an update to a Category 1 CPT code, and January 2027 remains the target for an effective date.