MediWound(MDWD) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q2 2024 was $5.1 million, an increase from $4.8 million in Q2 2023, primarily attributed to revenue from Vericel [14] - Gross profit for Q2 2024 was $0.4 million, representing 9% of total revenue, compared to $1.1 million or 24% in Q2 2023, with the decrease in gross margin due to changes in revenue mix and nonrecurring production costs [14] - Net loss for Q2 2024 was $6.3 million or $0.68 per share, compared to a net profit of $0.9 million or $0.10 per share in Q2 2023, primarily due to financial expenses from the revaluation of warrants [15] - Total revenue for the first half of 2024 was $10 million, up from $8.6 million in the first half of 2023 [16] - Net loss for the first half of 2024 was $16 million or $1.73 per share, compared to a net loss of $2.8 million or $0.32 per share in the first half of 2023 [16] Business Line Data and Key Metrics Changes - NexoBrid's revenue growth was driven by a 76% increase in hospital orders and the number of patients treated in the U.S. [6] - The new manufacturing facility for NexoBrid will increase manufacturing capacity sixfold, with full operational capacity expected in 2025 [6] - EscharEx received EUR 16.5 million in funding to expand its indications to include diabetic foot ulcers, significantly increasing its total addressable market [9] Market Data and Key Metrics Changes - Approximately 70 burn centers in the U.S. have submitted to P&T committees, with over 40 centers obtaining approval and placing initial product orders for NexoBrid [6] - Among the 38 million diabetic patients in the U.S., approximately 30% will develop diabetic foot ulcers, with 1.6 million patients requiring debridement annually [10] Company Strategy and Development Direction - The company aims to become a global leader in tissue repair, focusing on completing the construction of a new manufacturing facility, accelerating NexoBrid revenue growth, and initiating the Phase III clinical trial of EscharEx [4] - A strategic collaboration agreement with Molnlycke Healthcare aims to enhance the company's strategic plans and create long-term value for stakeholders [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for NexoBrid escalating rapidly due to major market launches and growing governmental interest [20] - The company is well-positioned with resources to achieve its goals and looks forward to an exciting second half of the year [18] Other Important Information - The company raised $25 million in financing led by Molnlycke, reflecting strong confidence in its technology and significantly enhancing its financial position [5] - The company received additional funding from the U.S. Department of Defense to support ongoing research and development activities [9] Q&A Session Summary Question: What are the next steps to increasing NexoBrid capacity? - Management indicated that commissioning the new facility will take about a year, including six months of stability testing [20] Question: How will the EIC funding for the DFU trial be structured? - The funding will be reimbursed quarterly based on expenses, and the trial is expected to start after regulatory negotiations [21] Question: What is the timeline for the Phase III study for venous leg ulcers? - The Phase III study is on track to start in the second half of 2024, with an interim assessment planned after 67% of participants have completed the trial [23] Question: How will the EIC data be utilized for regulatory pathways? - The EIC data will support a Phase III trial similar to the venous leg ulcer study, with recruitment expected to begin one year later [29] Question: What is the expected coverage of the EIC funding for the DFU study? - The study is anticipated to be at zero cost for the company, as it will utilize existing infrastructure [31] Question: Is there interest from large players in collaborating on EscharEx? - There is significant interest from global wound care players in collaborating on EscharEx, although specific details cannot be disclosed [34]