MediWound Ltd. Q3 FY2025 earnings call

• EscharEx Update: Enrollment in the VALUE Phase III trial for venous leg ulcers (VLU) continues with U.S. sites active but EU sites had adjustments for regulatory requirements. Progress on diabetic foot ulcer (DFU) program with positive FDA feedback and awaiting EMA scientific advice. Updated U.S. market access and pricing assessment estimates annual peak sales of about $831 million for EscharEx.
• NexoBrid Update: Completed commissioning of expanded manufacturing facility, expecting full operational capacity by year-end 2025. Vericel reported record quarterly revenue for NexoBrid, with 38% y-o-y growth. NexoBrid approved in 45 countries, including Australia for adult and pediatric patients. Collaboration with BARDA paused due to government shutdown, but expected to resume.
• Financials: Third quarter net loss improved to $2.7 million vs. $10.3 million in 2024. First 9 months net loss reduced to $16.7 million vs. $26.3 million in 2024. Balance sheet strengthened with $30 million equity financing and $3.5 million from warrant exercises, resulting in $60 million cash on hand as of September 30, 2025.

In the third quarter of 2025, MediWound reported revenue of $5.4 million, up 23% year-over-year compared to $4.4 million in the same period of 2024. Gross profit for the quarter was $0.9 million, or 16.5% of revenue. For the first 9 months of 2025, revenue was $15.1 million compared to $14.4 million in the same period of 2024, with gross profit of $3 million, or 19.7% of revenue. The increase in revenue was primarily driven by higher development services revenue, including additional contracts with DoD. The gross margin improvement was due to a more favorable revenue mix.

• EscharEx trial enrollment in VLU continues with monitoring of trends and potential timeline updates.
• NexoBrid manufacturing facility expected to reach full operational capacity by year-end 2025.
• Current cash position provides flexibility to advance key programs and execute strategic priorities.

• EU site adjustments for EscharEx VLU trial may impact study timeline.
• Government shutdown caused pause in BARDA collaboration, creating uncertainty around timing of BARDA and DOD-related revenue in Q4.

Q: Josh Jennings from TD Cowen asked about the $831 million peak sales estimate for EscharEx, specifically assumptions.

A: Barry Wolfenson explained the analysis was market access focused, focusing on pricing with no change in patient numbers or adoption rates, with a max 50% premium over SANTYL and a conservative slice yielding $831 million.

Q: Josh Jennings also asked about DFU study trial design and centers.

A: Ofer Gonen stated they are not using the same centers as VLU, waiting for EMA feedback to finalize study design with alignment between regulators.

Q: RK from H.C. Wainwright asked about breakdown of $830 million peak sales between DFU and VLU.

A: Barry Wolfenson said more DFUs than VLUs, but VLU was first due to pain issue, with split roughly even with slight VLU weighting.

Q: RK also asked about BARDA collaboration and CPT code.

A: Ofer Gonen said BARDA program paused due to shutdown, expected to resume soon; Barry Wolfenson discussed CPT code's role in physician and institutional acceptance.

Q: Jeff Jones from Oppenheimer asked about revenue breakdown.

A: Hani Luxenburg said third quarter revenue breakdown not fully detailed, but gross margin improved due to revenue mix.

Q: Michael Okunewitch from Maxim Group asked about health economic benefit endpoints and factors leading to other debridement methods.

A: Barry Wolfenson explained HEOR based on early closure and cost savings, with factors like peripheral neuropathy in DFU leading to some preference for sharp debridement and autolytic debridement still having a market.