MediWound Ltd. Q3 FY2024 earnings call

Management Statement and Operational Highlights

• Secured FDA approval for pediatric indication of NexoBrid, expanding its label to cover all age groups in the US.
• Raised $25M through a private investment led by Mölnlycke Health Care.
• Completed construction of state-of-the-art GMP-compliant manufacturing facility for NexoBrid, with commissioning underway, expected to reach full operational capacity by end 2025, increasing manufacturing output six-fold.
• WHO designated enzymatic debridement as essential for burn injuries in mass casualty guidelines, reinforcing NexoBrid's role in emergency response.
• Finalized preparations for EscharEx Phase III study in venous leg ulcers and upcoming head-to-head trial vs collagenase.
• Received €16.25M EU funding for EscharEx diabetic foot ulcers program, addressing a significant unmet need.

Segment Performance

• NexoBrid: Commercial revenue met expectations, limited by capacity constraints. In the US, over 70 burn centers made P&T committee submissions, ~50 secured approval and placed initial orders. Vericel reported a 43% quarter-over-quarter increase in NexoBrid revenue. FDA approved pediatric indication for NexoBrid, eliminating BARDA funding activities and reducing associated revenue. Anticipated 2024 revenue is $20M vs prior guidance of $24M. Revenue driven by strong demand exceeding current manufacturing capacity.
• EscharEx: Completed preparations for Phase III study in venous leg ulcers, with IND submission planned by year-end. Upcoming head-to-head Phase II study vs collagenase. Received €16.25M in funding from the European Innovation Council for DFU program, accelerating timelines by four years.

Guidance

• Anticipates 2024 revenue of $20M for NexoBrid, down from prior guidance of $24M due to FDA approval of pediatric indication eliminating BARDA funding revenue and clinical activities for temperature-stable formulation postponed to 2026.
• Phase III study for EscharEx in venous leg ulcers to commence with IND submission planned by year-end, with enrollment expected 30 days after IND submission.

Risks

• Actual outcomes and results subject to risks and uncertainties beyond MediWound's control, as outlined in press release and SEC filings.
• Capacity constraints limiting NexoBrid revenue.
• Need for regulatory approvals for manufacturing facility commercial availability.

Question and Answer

Q: Josh Jennings asked about EscharEx Phase III IND submission, interaction with FDA, and trial enrollment.

A: IND submission expected end 2024, enrollment to begin 30 days after IND submission.

Q: Unidentified Analyst asked about Phase II head-to-head study success expectations.

A: Study designed similarly to prior Phase II, expects similar effects, predefined study to support pricing discussions.

Q: RK asked about Category III CPT code impact, DFU study timeline, Type C meeting with FDA.

A: CPT code unlikely to have immediate impact; DFU study needs protocol, FDA and EMA approval, with an estimated 1-year timeline; Type C meeting involves facility construction and CMC data preparation for temperature-stable formulation.

Q: Michael Okunewitch asked about temperature-stable formulation clinical work and Europe stockpiling.

A: Expecting small trial for temperature-stable formulation; stockpiling potential in Europe is low tens of millions, with temperature-stable formulation development ongoing.