[Management View]
MediWound reported a total revenue of $4 million for Q1 2025, a decrease from $5 million in Q1 2024, attributed to lower BARDA-funded development services. Gross margin improved to 19% from 12% due to a favorable change in revenue mix. The EscharEx program is advancing on schedule, with significant external validation from key wound care industry partners. NexoBrid achieved record U.S. commercial growth and is experiencing demand surpassing production capacity internationally.

[Outlook]
The company anticipates the EscharEx VALUE Phase 3 interim readout at 65% enrollment in mid-2026. A 45-patient head-to-head trial versus collagenase will begin in the second half of 2025. The new manufacturing facility is on track for operational readiness by year-end, with site selection for a US-based backup facility projected to be finalized in Q3 2025. BARDA/DOD funding guidance remains unchanged despite earlier delays.

[Financial Performance]
- Total Revenue: $4 million, down from $5 million in Q1 2024.
- Gross Profit: $0.7 million, with gross margin rising to 19% from 12%.
- R&D Expenses: $2.9 million, up from $1.5 million in Q1 2024.
- SG&A Expenses: $3.1 million, compared to $2.9 million in Q1 2024.
- Operating Loss: $5.2 million, compared to $3.7 million in Q1 2024.
- Net Loss: $0.7 million or $0.07 per share, improved from $9.7 million or $1.05 per share in Q1 2024.
- Adjusted EBITDA Loss: $4 million, compared to $2.9 million in Q1 2024.
- Cash Position: $38.7 million as of March 31, 2025, down from $43.6 million at year-end 2024.

[Q&A Highlights]
Question 1: Can you remind us what is yet to be done to be ready for scale-up by year-end? Any feedback from relevant agencies around the timing of regulatory approvals, particularly with the FDA?
Answer: The demand for NexoBrid is increasing due to several factors, including major market launches and expanding indications. The new facility is in the commissioning phase and is on time for operational capacity by the end of 2025. EMA inspections are expected sooner, while FDA inspections are anticipated around mid-2026.

Question 2: Any thoughts on the timing for the US-based manufacturing facility and formal agreements with the US government?
Answer: The US government has expressed interest in a domestic backup manufacturing site. Projects are expected to be finished by Q3 this year, with details on location and timing to follow. This project is fully supported by BARDA.

Question 3: Any incremental thoughts from clinicians at SAWC regarding the VLU study? Is enrollment progressing as expected?
Answer: The trial is significant and comprehensive, with strong collaboration from leading wound care companies and top KOLs. Recruitment is progressing as planned, with interim data expected by mid-2026.

Question 4: How are you planning for NexoBrid stockpiling, and what could be the expected dollar amounts?
Answer: The priority is to treat patients rather than stockpile. Governments are aware of this preference. Revenue guidance includes expected government demand, with growing interest following the Israeli-Hamas war.

Question 5: What percentage of the EscharEx Phase 3 trial sites are in the US, and could the study be completed ahead of time?
Answer: Approximately 50% of the sites are in the US. Enrollment is not expected to be an issue, with a focus on recruiting the right patients. The trial is planned to proceed as scheduled.

Question 6: Will the Phase 2 head-to-head study against collagenase be completed ahead of the Phase 3 study?
Answer: The head-to-head study is expected to be completed ahead of the Phase 3 study. It is a shorter and simpler trial, focusing on safety, market aspects, and pricing.

Question 7: What considerations might go into the pricing strategy for EscharEx?
Answer: The current model compares the average cost of Santyl with EscharEx. A full market research study on market access and pricing will consider downstream impacts, such as reduced healthcare utilization.

Question 8: Would new stockpiling programs for NexoBrid come from the expanded manufacturing facility or a dedicated domestic program?
Answer: Flexibility is planned, with multiple facilities supporting demand. The new US backup facility will also support stockpiling and potentially EscharEx manufacturing.

Question 9: How should we think about the BARDA and DOD funding environment and its impact on revenue?
Answer: Despite earlier delays, all programs are back on track, and the 2025 funding outlook remains unchanged. Revenue guidance of $24 million for 2025 is expected to be met.

Question 10: How should we think about the financial income/expense line going forward?
Answer: The financial income/expense line is influenced by share price revaluation of warrants. It is volatile and depends on market conditions. Warrants expire in November 2026, after which this issue will disappear.

[Sentiment Analysis]
The tone of the management was confident and focused on strategic execution. Analysts' questions were detailed and forward-looking, reflecting interest in the company's progress and future plans.

[Quarterly Comparison]
| Key Metrics | Q1 2025 | Q1 2024 |
|------------------------|---------------|---------------|
| Total Revenue | $4 million | $5 million |
| Gross Profit | $0.7 million | $0.6 million |
| Gross Margin | 19% | 12% |
| R&D Expenses | $2.9 million | $1.5 million |
| SG&A Expenses | $3.1 million | $2.9 million |
| Operating Loss | $5.2 million | $3.7 million |
| Net Loss | $0.7 million | $9.7 million |
| Adjusted EBITDA Loss | $4 million | $2.9 million |
| Cash Position | $38.7 million | $43.6 million |

[Risks and Concerns]
- Regulatory approval timelines for the new manufacturing facility.
- Potential delays in the EscharEx VALUE Phase 3 trial.
- Dependence on BARDA and DOD funding.
- Volatility in financial income/expense due to warrant revaluation.

[Final Takeaway]
MediWound's Q1 2025 performance reflects strategic progress in its key programs, despite a decrease in total revenue. The EscharEx program is advancing with strong external validation, and NexoBrid is experiencing significant demand growth. The company is focused on scaling its manufacturing capabilities to meet future demand and support long-term growth. Investors should monitor regulatory approval timelines and the progress of clinical trials as key factors influencing future performance.