MediWound(MDWD) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [15] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [15] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [16] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share in the previous year [16] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [16] - Cash and cash equivalents as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [17] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid revenue reported a 207% year-over-year increase and a 31% sequential increase during Q1 2025, with consistent ordering from nearly 60 burn centers in the U.S. [11] - Demand for NexoBrid continues to exceed manufacturing capacity in Japan and Europe, with a new manufacturing facility expected to be operational by year-end 2025 [12] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support clinical and regulatory advancement of EscharEx for diabetic foot ulcers [8] - The company is experiencing growing interest from governments for stockpiling NexoBrid as part of global emergency preparedness efforts [14] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [19] - Strategic research collaborations have been strengthened, with participation from major global wound care companies in clinical development programs [8] - The company aims to position EscharEx as a global leader in enzymatic wound debridement, supported by strong clinical data and partnerships [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates that the VALUE Phase III trial will yield positive results, which would support regulatory submissions and commercial positioning [6] - Management noted that the U.S. government has shown interest in establishing a domestic backup manufacturing site, with planning for this project expected to be completed by Q3 2025 [26] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The company is also preparing for potential stockpiling of NexoBrid, with discussions ongoing with various governments [36] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [24] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [27] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [30] Question: How is the company planning for stockpiling of NexoBrid? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [36] Question: What is the structure of the sites for the EscharEx trial? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [38] Question: Will the head-to-head study results come before the Phase III study? - The head-to-head study is expected to finish ahead of the Phase III study due to its shorter duration [42] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider the cost of treatment duration and health economics related to faster debridement [50] Question: How will the new U.S. backup manufacturing facility support demand? - The facility will not only serve as a backup but also expand manufacturing capabilities for both NexoBrid and EscharEx [53]