MediWound Ltd. Q2 FY2025 earnings call

• EscharEx VALUE Phase III trial is actively enrolling patients, with new collaborations established with Convatec and Essity. A post-hoc analysis from an earlier Phase II study was published, confirming wound bed preparation is a key predictor of healing in venous leg ulcers.
• NexoBrid continues to gain traction in the U.S. market, with partner Vericel reporting 52% year-over-year revenue growth. Commissioning of the manufacturing scale-up is on track for completion by year-end. Received additional $3.6 million in non-dilutive funding from the U.S. Department of Defense for a room temperature-stable formulation of NexoBrid.
• Focus on 3 core objectives: advancing EscharEx VALUE Phase III trial, completing commissioning of expanded manufacturing facility, and building global recognition of EscharEx through clinical collaborations and publications.

In the second quarter of 2025, total revenue was $5.7 million, up 43% sequentially and year-over-year. Gross profit for the quarter was $1.3 million (23.5% of revenue) compared to $0.4 million (8.8%) in the prior year period. For the first half of 2025, total revenue was $9.7 million (slightly down from $10 million in H1 2024). Gross profit was $2.1 million (21.5% of revenue) compared to $1.1 million (10.5%) in the prior year period. The revenue growth reflects higher product sales and favorable revenue mix, while gross profit margin increased due to a more favorable revenue mix.

• Guidance of $24 million revenue in 2025. Expect EMA approval for the new facility in the first half of 2026 and FDA approval in the second half of 2026. Revenue ramp-up in the second half of 2025 is from development services, with NexoBrid revenue ramp-up to occur once the new facility is approved.
• Anticipate meeting the $24 million revenue guidance for 2025, with revenue from development services contributing to the ramp-up in the second half.

• Regulatory delays in Europe for EscharEx Phase III trial activation due to multi-country coordination. Potential impacts of political environment on BARDA funding. Competition for trial sites and patients. Uncertainties regarding FDA inspection timelines for the new manufacturing facility.

Q: Any upcoming publications for EscharEx and update on head-to-head trial versus SANTYL?

A: There are other publications in the pipeline related to diabetic foot ulcer trials, with focus on gaining KOL appetite before trial kick-off. The head-to-head trial comparing EscharEx directly to collagenase is on track to launch in the second half of 2025.

Q: Review of U.S. facility and BARDA funded planning and design?

A: U.S. government is interested in a domestic backup site for NexoBrid manufacturing. Funding of the process is 100% by BARDA, with plans to discuss funding of the facility as a whole once site details are known.

Q: Elements of BARDA's RFP for enzymatic debridement products and progress for NexoBrid franchise?

A: BARDA's RFP covers stockpiling of NexoBrid, room temperature-stable formulation, and trauma/blast injury solutions. Program expected to start in Q4 2025, a 10-year contract. Vericel is leading the RFP process in the U.S. with MediWound providing support.

Q: Addition of new compression method in Phase III VALUE trial and distribution?

A: Essity's medical compression therapy products will be used for patients who have come to complete closure in the follow-up period. It's standardized for those patients and doesn't change the trial timelines.

Q: Patient recruitment and enrollment for EscharEx VALUE study?

A: Enrollment is progressing well. 50% of centers in the U.S. are active and recruiting, while in Europe, activation is slower due to regulatory timelines but sites are being activated and on track to meet targets.

Q: Underserved areas for NexoBrid and demand with new manufacturing?

A: Demand is substantial across all regions, limited by current manufacturing capacity. Once new manufacturing is online, excess demand is expected to be filled in various regions as supply increases.

Q: DFU trial timelines and feedback from FDA?

A: Approaching FDA for feedback on protocol for DFU trial in the second half of 2025. Processes typically take around 90 days, with plans to start the trial in the second half of 2026.

Q: CTP skin sub reimbursement changes and impact on EscharEx?

A: Changes in CTP skin sub reimbursement will help clean up the industry, with only products with good clinical evidence eligible for reimbursement. EscharEx supports wound bed preparation, which is key for CTP application, and will be well-positioned.

Q: Manufacturing expansion timeline and FDA inspection for NexoBrid?

A: Commissioning of manufacturing scale-up is on track for completion by year-end. Expect EMA approval in H1 2026 and FDA approval in H2 2026. FDA inspections for non-U.S. facilities are not seen as a problem, with EMA approval expected earlier due to Israeli inspectors.

Q: BARDA RFP and DoD funding for room temperature-stable formulation?

A: Both BARDA and DoD are interested in the room temperature-stable formulation program. BARDA's RFP highlights this area, and both agencies see relevance for civilian and military uses.