MediWound(MDWD) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $5.7 million, up from $5.1 million in Q2 2024, reflecting a 43% sequential growth and an increase year over year [10] - Gross profit for the quarter was $1.3 million, representing 23.5% of revenue, compared to $400,000 or 8.8% in the prior year period, indicating a significant margin increase [11] - Net loss for Q2 2025 was $13.3 million or $1.23 per share, compared to a net loss of $6.3 million or $0.68 per share in the same period last year [12] Business Line Data and Key Metrics Changes - NexoBrid reported a 52% year-over-year revenue growth in Q2 2025, driven by increases in hospital unit orders and the number of ordering centers [8] - Research and development expenses rose to $3.5 million in Q2 2025 from $1.9 million in Q2 2024, primarily due to investments in the EscharEx VALUE Phase III study [11] Market Data and Key Metrics Changes - The EscharEx VALUE Phase III trial is actively enrolling patients, aiming to enroll 216 patients across 40 sites in the U.S. and Europe [5] - The commissioning of the new manufacturing facility is on track for completion by year-end 2025, which is critical for supporting global growth [9] Company Strategy and Development Direction - The company remains focused on three core objectives: advancing the EscharEx VALUE Phase III trial, completing the commissioning of the expanded manufacturing facility, and building global recognition of EscharEx through clinical collaborations and publications [17] - The company has established new collaborations with ConvaTec and SCT to support ongoing trials, reinforcing the validation of EscharEx within the wound care ecosystem [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving several key milestones over the next twelve months, which are expected to advance strategic and financial objectives [5] - The company noted that the demand for NexoBrid is rising, and they are addressing capacity issues to support global growth [67] Other Important Information - The company received an additional $3.6 million in non-dilutive funding from the U.S. Department of Defense, bringing total program funding to $18.2 million [9] - As of June 30, 2025, the company had $32.9 million in cash and cash equivalents, down from $43.6 million at the end of 2024 [14] Q&A Session Summary Question: Are there any upcoming publications to be aware of? - Management indicated that there are several publications planned, particularly focusing on diabetic foot ulcer trials, with expectations for additional publications around major conferences [20] Question: Can you provide an update on the head-to-head trial versus Santyl? - The randomized study comparing EscharEx directly to collagenase is on track, with plans to enroll 45 VLU patients [21] Question: What is the status of the U.S. facility and BARDA funding? - The U.S. facility planning is fully funded by BARDA, and the company is preparing for the next steps in discussions with the U.S. government regarding the facility's funding [23][24] Question: How is the patient recruitment for the VALUE study progressing? - Enrollment is progressing well, with most U.S. sites active and recruiting, while European site activation is slightly slower due to regulatory timelines [41] Question: What areas are underserved for NexoBrid? - Demand is substantial across all regions, and the company is focused on meeting guidance for upcoming years, with expectations for better clarity on demand after the new facility is completed [46] Question: What are the expected timelines for the new NexoBrid facility? - The company expects to file for regulatory approvals in the EU and the U.S. in 2026, with EMA approval anticipated first [68]