MediWound(US:MDWD)2023-11-21 18:14Financial Data and Key Metrics Changes - The company's revenue for the first nine months of 2023 totaled $13.3 million, a decrease from $14.9 million in the same period of 2022 [3] - The operating loss for this period was $11.4 million, compared to an operating loss of $10.5 million recorded in the same period last year [3] - The net loss for the first nine months was $5 million or $0.56 per share, which is a significant improvement from a net loss of $12.1 million or $2.67 per share for the first nine months of 2022 [3] - The non-GAAP adjusted EBITDA showed a loss of $9 million, compared to a loss of $7.9 million reported in the first nine months of 2022 [3] - As of September 30, 2023, the company's cash, restricted cash, and investments were at $46 million, an increase from $34.1 million reported on December 31, 2022 [19] Business Line Data and Key Metrics Changes - NexoBrid was successfully launched in the United States and Japan, with positive initial feedback from the Japanese market [25][40] - The CHMP recommended NexoBrid label extension to include pediatric indications, significantly increasing its addressable market [25] - The company reported revenue of $4.8 million for the third quarter, a decrease from $5.8 million in the same quarter of the previous year [49] - Gross profit for the quarter stood at $0.9 million or 19% of total revenues compared to $2.4 million or 41.9% of total revenue in the third quarter of 2022 [49] Market Data and Key Metrics Changes - The Japanese market for NexoBrid is substantial, with over 6,000 patients annually receiving treatment for severe burns [5] - The global demand for NexoBrid has risen, fueled by geopolitical conflicts and governmental actions [38][42] - The company anticipates a substantial increase in NexoBrid's revenue following the completion of its scale-up [12] Company Strategy and Development Direction - The company is focused on expanding operational capabilities to meet rising global demand for NexoBrid [30] - The construction of a new GMP-compliant facility is on schedule for completion by mid-2024, with full-scale manufacturing capabilities expected in 2025 [30][69] - The company aims to maintain its manufacturing targets and expand production capabilities to address surging demand [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for NexoBrid's global revenue growth, driven by commercial launches and rising governmental interests [11] - The company is committed to addressing the current demand for NexoBrid, which exceeds its manufacturing capacity [64] - Management highlighted the importance of the upcoming Phase III study for EscharEx, with enrollment expected to begin in the second half of 2024 [39] Other Important Information - The company secured a $6.5 million R&D budget from the Department of Defense to advance the development of a new temperature-stable formulation for NexoBrid [43] - The company has received guidance from both the FDA and EMA on the protocol for the global Phase III study of EscharEx [45] Q&A Session Summary Question: Can you expand on the commercialization of NexoBrid in Japan? - Management noted that initial feedback from Kaken Pharmaceutical is positive, and they are working to secure contracts in key hospital systems [5] Question: What is the timeline for the EscharEx trial and interim assessment? - Management indicated that the interim assessment is planned after 67% of patients have completed the trial, with a focus on efficacy data [70] Question: How does the manufacturing scale-up impact profitability? - Management stated that the scale-up is expected to generate meaningful revenue in 2025, with profitability anticipated in 2026 or 2027 [74]