MediWound (MDWD) Q2 FY26 earnings call: guidance and Q&A

Confirmation of Q1 2027 milestones for EscharEx VLU study and impact of Smith & Nephew's second-generation SANTYL on EscharEx development.

Confirmed Q1 2027 target for interim assessment and enrollment completion. Noted Smith & Nephew's comments on SANTYL's slowness, but highlighted EscharEx's substantial clinical lead in Phase III for chronic wounds, with their competitor's product not yet in clinical development for chronic wounds.

“Yes, our target of meeting the interim assessment and the enrollment completion is still in the first quarter of 2027.”

asked by Swayampakula Ramakanth · answered by Ofer Gonen

Inquiry if SANTYL's ineffectiveness implies a larger market for EscharEx, and details on the pressure ulcer study (IIT, data availability for filing).

Affirmed that SANTYL's limitations suggest a much larger market for effective debridement, with EscharEx's peak sales potential over $1 billion. Explained the pressure ulcer study is an investigator-initiated, small, open-label trial starting Q4 2026, with plans to approach FDA for approval requirements after VLU readout.

“We believe that a drug for debridement that can reach complete debridement, certainly within four to five days changes the entire expectation with regard to enzymatic debridement. It fits better into the workflows of wound clinics and podiatry offices and it takes away because of that share -- utilization share, not just from sharp debridement, but across all different modalities. So, we do believe that it greatly expands the market.”

asked by Swayampakula Ramakanth · answered by Barry Wolfenson

Details on EMA requests for the new plant, potential delays to product availability, and status of the CPT code.

Clarified that EMA requested operational changes, not product quality issues, to be completed by Q4 2026. Manufacturing will start in early 2027, with regulatory approval and commercial supply expected H2 2027, not 2028. Stated no publicly available information on a Category 1 CPT code update.

“As I said in the call, we completed the EMA pre-audit and the pre-audit process, and they recommended some operational changes that we are about to complete in the fourth quarter of this year, not the fourth quarter of 2027.”

asked by Swayampakula Ramakanth · answered by Ofer Gonen

Request for additional details on the updated MSA with Vericel, particularly revenue recognition for new development programs, and updates on the DFU clinical development program.

Stated confidentiality obligations prevent sharing full details on the MSA, but confirmed the first development program (blast injury) is underway, and revenue recognition for MediWound begins H2 2026. For DFU, constructive discussions with FDA/EMA have led to an aligned protocol, with a Phase II study (50 patients, EscharEx vs placebo, primary endpoint time to complete debridement) planned for Q4 2026.

“What is concrete today is that the MSA is signed. The first development program, the blast injury, pain friction injuries is underway, and Vericel expects about $6 million of BARDA procurement revenue in the second half. Additional elements, including the room temperature stable formulation, the U.S.-based manufacturing readiness, -- these are areas that we are now in discussions with Vericel and BARDA regarding the scope, timing, technical requirements and potential implementation pathway.”

asked by Joshua Jennings · answered by Ofer Gonen

Clarification on MediWound's projected BARDA revenue vs. Vericel's stated procurement, and how NexoBrid revenue will be impacted by the H2 2027 facility online date.

Clarified that MediWound's projected revenue includes other government agreements (e.g., Department of War) beyond BARDA. The MSA with Vericel has multiple components beyond procurement. Stated the facility timeline will not materially impact 2026 revenue guidance, as H2 revenue is driven by development activity and existing agreements. Expects no impact on 2027 and 2028 NexoBrid revenue as manufacturing will start in early 2027.

“Jeff, we do not actually expect the current facility timeline to have material impact on our 2026 revenue guidance. Importantly, a meaningful portion of the revenue we expect in the second half is associated, as you know, with government-funded development activity and product supply under existing agreements rather than being depending on commercial supply from our expanded facility.”

asked by Jeffrey Jones · answered by Hani Luxenburg

Inquiry about sequential enrollment rate trends, confirmation of active sites, and the timeline for top-line data post-enrollment.

Cannot share specific patient enrollment numbers to protect study integrity, but reaffirmed Q1 2027 target for interim assessment and enrollment completion, stating they are on track without needing improved trends. Confirmed nearly all 40 sites are recruiting. Explained top-line data is expected about a quarter after interim assessment, followed by final results a few months later.

“Our plan is to have the interim assessment by the end of Q1. If everything goes well, it takes another quarter or so to get the top line data. And after the top line data, it is another few months until the final results.”

asked by Chase Knickerbocker · answered by Ofer Gonen