MediWound (MDWD) Q1 2025 Earnings Call May 21, 2025 08:30 AM ET Company Participants Dan Ferry - Managing DirectorOfer Gonen - Chief Executive OfficerHani Luxenburg - Chief Financial OfficerRamakanth Swayampakula - Managing DirectorBarry Wolfenson - Executive Vice President of Strategy & Corporate Development Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareMichael Okunewitch - Senior Biotechnology AnalystScott Henry - Managing Director & Senior Research Analyst ...

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 [17] - 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 [17] - R&D expenses totaled $2.9 million, up from $1.5 million in Q1 2024, reflecting continued investment in the EscharEx VALUE Phase III trial [17] - SG&A expenses were $3.1 million, compared to $2.9 million in the prior year [17] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [17] - 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 last year [17] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [17] - Cash, cash equivalents, and deposits as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [19] 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's U.S. adoption continues to expand, with a 207% year-over-year increase and a 31% sequential increase in revenue during Q1 2025 [12] - Demand for NexoBrid in Japan and Europe continues to exceed manufacturing capacity, with a new manufacturing facility expected to be operational by year-end 2025 [12][13] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support the clinical and regulatory advancement of EscharEx for diabetic foot ulcers [9] - The U.S. government has expressed interest in establishing a domestic backup manufacturing site for NexoBrid, supported by BARDA [15][25] 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 [21] - EscharEx is positioned to become a global leader in enzymatic wound debridement, with strong clinical advantages over competitors [11] - The company is advancing complementary studies to support market access and future commercial success [20] 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 achieving operational capacity for the new manufacturing facility by the end of 2025, with regulatory inspections expected thereafter [25] - Management remains optimistic about the VALUE Phase III trial and expects interim data by mid-2026 [31] 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 pediatric Phase III study results for NexoBrid were published, reinforcing its efficacy and safety [13] 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 [25] 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 [28] 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 [31] Question: How is the stockpiling of NexoBrid being planned? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [37] Question: What is the structure of the EscharEx trial sites? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [39] Question: Will the results of the head-to-head study and phase three study come around the same time? - The head-to-head study is expected to finish ahead of the phase three study due to its shorter duration [43] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider treatment costs, health economics, and potential savings from faster debridement [51] Question: How should investors think about BARDA and DoD funding? - The company anticipates no material impact on revenue outlook for 2025, with programs back on track [61]

"We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum established in 2024," said Ofer Gonen, Chief Executive Officer of MediWound. "The VALUE Phase III study for EscharEx remains on schedule, and our additional collaboration with Kerecis marks a significant milestone—bringing nearly all leading global wound care companies into our clinical research programs. Meanwhile, NexoBrid continues to gain global traction, as we advance strategic m ...

YAVNE, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company’s Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx® compared with collagenase ointment (SANTYL®), the only FDA-cleared enzymatic debridement agent commercial ...

Wound Healing Society (WHS) Symposium on Advanced Wound Care (SAWC) "These new data further validate EscharEx's unique mechanism of action and its potential to redefine the standard of care for chronic wound management," said Dr. Robert Snyder, Chief Medical Officer at MediWound. "We remain committed to advancing EscharEx through rigorous clinical development, with the goal of offering a meaningful, non-surgical solution for patients suffering from chronic wounds." Presentations at WHS and SAWC to highlight ...