MediWound Ltd. Q4 FY2024 earnings call

Management Statement and Operational Highlights

• 2024 was transformative with strong execution, clinical development progress (EscharEx Phase 3 VLU trial, NexoBrid pediatric approval), commercial expansion, and strategic partnerships. EscharEx Phase 3 VLU trial derisked with larger sample size, interim analysis mid-2026, full completion end 2026. NexoBrid saw commercial growth, positive results from expanded access protocol, and completed GMP facility construction. Strengthened balance sheet with $25M PIPE financing, secured EU funding for EscharEx DFU trial, and collaborations with Kerecis and others for DFU trial.

Segment Performance

• EscharEx: In early 2024, head-to-head analysis vs SANTYL (FDA-approved enzymatic debridement product, ~$370M annual revenue) showed EscharEx's superiority in complete debridement, time to complete debridement, wound bed preparation, and wound closure. Peak sales potential for primary indications (sled ulcers, diabetic foot ulcers) is ~$725M. Phase 3 VALUE Global trial for venous leg ulcers (VLU) with 216 patients across 40 sites in US and Europe, co-primary endpoints: incidence of complete debridement and wound closure. Plan for 45-patient Phase 2 head-to-head comparison vs collagenase in 2025.
• NexoBrid: 2024 revenue $20.2M. Projected $24M in 2025, driven by expanding sales in Europe (90+ burn centers), Japan (400+ medical facilities using), and US (42% increase in hospital orders Q4 2024). FDA approval for pediatric patients (newborn to 18 years). State-of-the-art GMP manufacturing facility under construction, expected full operational capacity late 2025, with regulatory approvals expected in 2026.

Guidance

• NexoBrid projected revenue $24M in 2025, capped by manufacturing capabilities. EscharEx Phase 3 VLU trial interim analysis mid-2026, full completion end 2026. Plan for Phase 2 head-to-head comparison vs collagenase in 2025 to support BLA submission and commercial readiness.

Risks

• Regulatory approval timelines for manufacturing facility and product indications could delay revenue from NexoBrid. Market competition in wound care products may impact EscharEx adoption. Uncertainty in clinical trial outcomes (e.g., VLU trial enrollment and interim analysis) could affect product launch and market penetration.

Question and Answer

Q: Josh Jennings asks about collaborators in EscharEx VALUE study and their role beyond supplying products.

A: Barry Wolfenson responds that standardized products help minimize variability in the study, and collaborators provide training, including an investigators meeting in Philadelphia with training for sites.

Q: Francois Brisebois asks about Medicare update and interim analysis of EscharEx trial.

A: Barry Wolfenson explains Medicare LCD changes and how EscharEx benefits from documentation requirements for wound debridement and granulation tissue. Ofer Gonen discusses interim assessment timing (mid-2026) and protocol flexibility for the VLU trial.

Q: RK asks about SANTYL vs EscharEx performance and VLU study enrollment.

A: Barry Wolfenson compares EscharEx vs SANTYL in debridement and wound closure, highlighting EscharEx's faster results. Ofer Gonen says VLU study enrollment is focused on quality, aiming for half a patient per center per month.

Q: Chase Knickerbocker asks about site activation and R&D spend in 2025.

A: Ofer Gonen says site activation for EscharEx VLU study is on track with enthusiastic sites. Hani Luxenburg notes R&D spend will increase in 2025 due to per-patient costs for the VLU trial.

Q: Michael Okunewitch asks about DFU study collaboration and 2025 revenue guidance.

A: Ofer Gonen explains partnership with Kerecis for diabetic foot ulcers, leveraging their fish skin graft. Revenue guidance for 2025 is from increased manufacturing weeks and higher prices for NexoBrid.