MediWound(US:MDWD)2022-11-15 17:30Financial Data and Key Metrics Changes - Total revenues for Q3 2022 were $5.8 million, a decrease from $6.4 million in Q3 2021 [30] - Revenues from products in Q3 2022 were $1.4 million, down from $2.6 million, primarily due to a $1 million decrease in emergency stockpile procurement by BARDA [30] - Gross profit for Q3 2022 was $2.4 million, or 42% of net revenues, compared to a gross profit of $2.5 million, or 39% of net revenues in the prior year [30] - Operating loss for Q3 2022 was $3.5 million, compared to $2.9 million in Q3 2021 [33] - Net loss for Q3 2022 was $4.2 million, or $0.13 per share, compared to a net loss of $3.3 million, or $0.12 per share in the previous year [34] - Adjusted EBITDA for Q3 2022 was a loss of $2.5 million, compared to a loss of $2.2 million in Q3 2021 [35] Business Line Data and Key Metrics Changes - The company is focused on the NexoBrid and EscharEx products, with NexoBrid expected to generate meaningful revenues in 2023 [9][10] - EscharEx has shown robust Phase 2 results, proving to be safe and effective, with plans to initiate a Phase 3 study in the first half of 2023 [15][17] Market Data and Key Metrics Changes - NexoBrid's BLA resubmission was accepted by the FDA, with a PDUFA date set for January 1, 2023 [20] - The company anticipates significant growth in NexoBrid sales in Europe and is preparing for launches in India and Japan [22][25] Company Strategy and Development Direction - The company aims to leverage a $1 billion market opportunity with EscharEx and has a mature pipeline with favorable data [10] - A strategic advisory board has been established to enhance operational activities and manufacturing processes [14] - The company is evaluating options for collaboration on EscharEx while maintaining flexibility due to recent funding [19][64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing significant catalysts ahead, including anticipated marketing approvals for NexoBrid [39] - The company is scaling up manufacturing to meet growing demand and is prepared for pivotal development programs [40] - Management highlighted the importance of the pediatric market for NexoBrid, which represents a significant opportunity [58] Other Important Information - The company completed a capital raise of $30 million to support activities through 2025 [11][38] - The company has $17.6 million in cash and short-term investments as of September 30, 2022, compared to $11 million at the end of 2021 [37] Q&A Session Summary Question: Progress on EscharEx and FDA interactions - Management confirmed they will meet with the FDA to discuss the Phase 3 study design and are considering strategic partnerships [44] Question: Revenue potential from NexoBrid - Expected $7.5 million milestone payment from Vericel upon BLA approval, with additional revenue anticipated from launches in Japan and India [46] Question: Design of Phase 3 study for EscharEx - Management aims for a similar design to the successful Phase 2 study and expects clarity on regulatory paths soon [49][51] Question: Expanded Access Program (EAP) insights - The EAP has treated 183 patients, providing valuable feedback that supports the belief that NexoBrid will become standard care in the U.S. [57] Question: Market management strategies in India and Japan - The company has established partnerships in both markets and is optimistic about the acceptance of NexoBrid [61][62] Question: Potential collaborations for EscharEx - Management is receiving interest from strategic players and is flexible in terms of partnerships due to recent funding [64]