MediWound Ltd. Q4 FY2025 earnings call

2025 was pivotal for MediWUN with two growth drivers: Phase III value trial for Escarex advancing as planned and operational extended manufacturing facility for NexoBridge. Escarex enrollment ongoing in Global Phase III Value Study in venous leg ulcers, targeting 216 patients across ~40 sites in US and Europe, expecting interim assessment and enrollment completion by year-end 2026. Expanding STOREX clinical program to diabetic foot ulcers and pressure ulcers, with phase two protocol in diabetic foot ulcers aligned with FDA and EMA to start in second half of 2026, and prospective investigator initiative study in pressure ulcers to begin in second half of 2026. Bea Brown joined Escarex clinical development program. NexoBridge's expanded manufacturing facility operational, increasing production capacity six-fold, commercial availability subject to regulatory approvals in 2026. Adoption of NexoBridge expanding in US with utilization across over 70 burn centers. Real-world data from Israel Defense Forces and military analysis support NexoBridge's role in severe burns. Intend to prioritize support for national preparedness initiatives post-regulatory clearance of expanded facility.

Fourth quarter 2025 revenue was $1.9 million vs $5.8 million in 2024, decrease due to lower development services revenue. Gross profit $0.3 million (14.9% of revenue) vs $0.9 million (15.5%) in 2024. R&D expenses $4.5 million vs $3 million in 2024. SG&A expenses $3.6 million vs $4 million in 2024. Operating loss $7.8 million vs $6.1 million in 2024. Net loss $7.2 million vs $3.9 million in 2024. Full year 2025 revenue $17 million vs $20.2 million in 2024. Gross profit $3.3 million (19.2% of revenue) vs $2.6 million (13%) in 2024. R&D expenses $14.3 million vs $8.9 million in 2024. SG&A expenses $14.2 million vs $13.1 million in 2024. Operating loss $25.3 million vs $19.4 million in 2024. Net loss $23.9 million vs $30.2 million in 2024. Adjusted EBITDA loss for fourth quarter 2025 was $6.5 million vs $4.9 million in 2024. Adjusted EBITDA loss for full year 2025 was $20.3 million vs $14.8 million in 2024. Cash, cash equivalents and deposits as of Dec 31, 2025 was $53.6 million vs $43.6 million in 2024.

Reaffirms revenue guidance of $24 to $26 million for 2026, $32 to $35 million for 2027, and $50 to $55 million for 2028. Guidance assumes continued support from BARDA and US Department of War, with 2028 outlook including potential initial contribution from Escarex subject to regulatory approval.

Q: Josh Jennings from TD Cowan asked about Nexabrid's manufacturing expansion, pent-up demand and timing.

A: Expanded facility operational, capacity six-fold, commercial output subject to regulatory approvals in 2026. Guidance assumes regulatory approval in second half of 2026.

Q: Josh Jennings asked about pressure ulcer trial and peak sales.

A: Barry said they'll start investigator-led pressure ulcer study this year, with third-party market research project, and pressure ulcers are the third of the big three ulcer types.

Q: Jeff Jones from Oppenheimer asked about BARDA support and new contracts.

A: BARDA issued RFP in Aug 2025, VeriCell leading process, expect resumption of progress. Collaboration with Department of War has $18.2 million non-dilutive funding.

Q: HC Wainwright asked about BBRON research collaboration and long-term strategy.

A: Barry said there are seven research collaborations with market-leading advanced wound care companies, they supply products needed for standard of care in wound care studies.

Q: HC Wainwright asked about value trial's adaptive adjustment and sample size.

A: Pre-specified interim sample size assessment after ~65% of patients complete treatment, may continue as planned or increase sample size with impact on timeline and cost.

Q: HC Wainwright asked about supply chain impact from geopolitical situation.

A: Across sites in Europe and US, enough Escarex to support trial for next at least six months, no supply chain issue impacting study.

Q: HC Wainwright asked about 2025 revenue decrease and 2026 guidance split.

A: Decrease primarily due to US government shutdown, not sharing split of 2026 guidance.

Q: Chase Knickerbocker from Craig Hallam asked about phase two for DFU vs previous design.

A: Consulted with agencies, decided on phase two study for DFU.

Q: Chase Knickerbocker asked about pressure ulcer's SCRX label.

A: Barry said they'll have discussion with FDA around necessity of large-scale Phase III studies for each indication, intend to have well-designed phase two study complemented by post-marketing real-world data.

Q: Michael Okonowicz from Maxim Group asked about pressure ulcer program prioritization.

A: Largest unmet need is venous leg ulcers, pressure ulcers are more complicated, will start with relatively mild ones, do small trial and market research.

Q: Michael Okonowicz asked about head-to-head study status.

A: Doing supportive studies, will start head-to-head study vs collagenase or other standard of care around mid-2026.

Q: Michael Okonowicz asked about enrollment targets for value study.

A: Not sharing enrollment numbers or trends, but feel comfortable with target of interim assessment and enrollment completion by year-end.

Q: Scott Henry from AGP asked about interim analysis timing and BARDA revenues.

A: Interim analysis expected by year end. Revenue guidance assumes initial revenue from BARDA agreements will be from Q2. Second half of 2026 expected to have significant increase in revenues over first half due to manufacturing capacity and BARDA revenues.