MDWD — MediWound Ltd.

Summary of MediWound (MDWD) Q1 2026 Earnings Call

1. Key Financial Results and Metrics:

• Revenue: $1.5 million, down from $4 million in Q1 2025, primarily due to timing of BARDA-related revenue and postponed shipments.
• Gross Profit: $0.3 million, with a gross margin of 21.9%, compared to $0.7 million (18.7% margin) in the prior year.
• R&D Expenses: Increased to $5.2 million from $2.9 million, reflecting investment in the EscharEx Phase III study.
• SG&A Expenses: Rose to $3.6 million from $3.1 million.
• Operating Loss: $8 million, compared to $5.2 million in Q1 2025.
• Net Loss: $3 million ($0.23 per share), compared to a net loss of $0.7 million ($0.07 per share) in the prior year.
• Adjusted EBITDA Loss: $7 million, up from $4 million in Q1 2025.
• Cash Position: $45 million as of March 31, 2026, down from $54 million at year-end 2025.

2. Strategic Updates and Business Highlights:

• EscharEx Development: Enrollment in the Phase III VALUE study for venous leg ulcers is ongoing, with over 30 active sites. Recruitment has been slower than expected due to regulatory adjustments and patient participation challenges.
• NexoBrid Growth: Continued commercial adoption and recognition, highlighted by a new 10-year BARDA contract worth up to $197 million for NexoBrid procurement and development.
• Collaborations: Expanded collaboration network with major wound care companies, including Medline, enhancing the clinical and commercial positioning of EscharEx.
• Manufacturing Expansion: Progressing towards commercial readiness of the expanded NexoBrid manufacturing facility, with modifications based on EMA feedback expected to be completed in the second half of 2026.

3. Forward Guidance and Outlook:

• 2026 Revenue Guidance: Reaffirmed at $24 million to $26 million, with expectations for revenue to be weighted towards the second half of the year, driven by government-related development services and procurement activities.

4. Challenges and Points of Concern:

• Enrollment Challenges: Slower recruitment in the VALUE study due to operational factors and patient complexities, though not related to safety or efficacy concerns.
• Revenue Decline: Significant drop in Q1 revenue compared to the previous year, attributed to timing issues and external factors like regional conflict affecting shipments.
• Regulatory Dependencies: Manufacturing capacity expansion in the U.S. is contingent on approvals from European regulators, which could delay product availability.

5. Notable Q&A Insights:

• Enrollment Timeline: Management expressed confidence in completing enrollment for the VALUE study by the end of Q1 2027, citing operational adjustments and patient support measures.
• Impact of Regulatory Changes: Changes in reimbursement policies for skin substitutes are expected to significantly reshape the chronic wound care market, potentially benefiting EscharEx as a differentiated product.
• Manufacturing Readiness: The U.S. manufacturing facility's readiness is tied to EMA approvals, with a focus on operational modifications rather than product quality concerns.
• BARDA Contract Details: Clarified that the BARDA contract involves multiple components, including procurement and development, with revenue expected to begin flowing in the second half of 2026.

Overall, while MediWound is facing challenges in enrollment and revenue timing, strategic partnerships and a strong pipeline position the company for potential growth in the latter half of 2026.