MediWound Ltd. (MDWD) Q1 2025 Earnings Call Transcript

MediWound (MDWD) reported Q1 2025 revenue of $4.0 million, down from $5.0 million year-over-year due to lower BARDA-funded development services revenue, but gross margin improved to 19%. The VALUE Phase III trial for EscharEx is progressing as planned, with interim data expected mid-2026, while NexoBrid continues to see strong US adoption with 207% year-over-year revenue growth reported by partner Vericel, though demand exceeds manufacturing capacity; a new facility is expected to be operational by year-end 2025. The company reiterated its 2025 revenue guidance of $24 million and highlighted growing government interest in NexoBrid stockpiling following its use in emergency situations.

Analysis

MediWound Ltd. (MDWD) reported Q1 2025 total revenues of $4.0 million, a decrease from $5.0 million in the prior year period, primarily due to lower revenues from BARDA-funded development services as the NexoBrid program nears completion. Despite the revenue decline, gross margin improved significantly to 19% from 12% year-over-year, reflecting a favorable shift in revenue mix. The company's operating loss widened to $5.2 million compared to $3.7 million in Q1 2024, driven by increased R&D expenses of $2.9 million primarily for the ongoing EscharEx VALUE Phase III trial. Notably, net loss narrowed substantially to $0.7 million, or $0.07 per share, from $9.7 million, or $1.05 per share, largely due to non-cash financial income related to warrant revaluation. MediWound's lead pipeline candidate, EscharEx, is progressing with its VALUE Phase III study in venous leg ulcers on schedule, with interim data anticipated in mid-2026; a supportive Phase II head-to-head trial against Collagenase is planned for H2 2025 to bolster market access and pricing strategies. Commercially, NexoBrid adoption in the U.S. is expanding, with partner Vericel reporting a 207% year-over-year increase in NexoBrid revenue for Q1 2025, though global demand continues to exceed current manufacturing capacity. To address this, MediWound's new manufacturing facility is on track for operational readiness by year-end 2025, with commercial availability expected in 2026 following regulatory approvals, which will also support growing government interest in stockpiling and a BARDA-supported U.S. manufacturing site. The company reiterated its 2025 revenue guidance of $24 million and projects $30-33 million for 2026, indicating confidence in its growth trajectory despite current manufacturing constraints.

Key Decisions for Investors

• Investors should closely monitor the progress of the EscharEx VALUE Phase III trial, particularly the interim data readout expected in mid-2026, which represents a significant upcoming catalyst for the company.
• The timely commissioning and regulatory approval of the new NexoBrid manufacturing facility by 2026 is a critical milestone to track, as it will enable MediWound to meet substantial unmet global demand and capitalize on revenue growth opportunities, including potential government stockpiling contracts.
• Careful attention should be paid to the company's cash utilization rate, which was $5.1 million in Q1 2025 against a cash balance of $38.7 million, in light of increased R&D expenditures for EscharEx and investments in manufacturing expansion.
• The strategic implications of BARDA's continued support for establishing U.S.-based manufacturing and the heightened interest from global governments in NexoBrid stockpiling should be considered, as these could translate into significant, stable revenue streams and enhanced emergency preparedness capabilities.