Financial Data and Key Metrics Changes - Quarterly revenue reached $24.2 million, an increase of over 20% compared to the same period in 2024, reflecting continued strong adoption [6][17] - Net income for the second quarter was $2.7 million, compared to a net loss of $13.7 million in the same quarter of the previous year [18] - Adjusted EBITDA for the second quarter was $9.8 million, compared to an adjusted EBITDA loss of $0.8 million for the same period in 2024 [18] - The company ended the quarter with approximately $81 million in cash and investments and generated $7.3 million in positive cash from operations [6][18] Business Line Data and Key Metrics Changes - U.S. sales of hepcidol were $22.5 million, while Kenosat sales in Europe were $1.7 million, showing significant growth from $6.6 million and $1.2 million respectively in the same period of 2024 [17] - Gross margins improved to 86% in the second quarter compared to 80% for the same period in the prior year [17] Market Data and Key Metrics Changes - The total hepcido treatment volume in 2025 is projected to increase by over 175% versus 2024 [10] - The company anticipates 25 to 28 operational centers by the end of the fourth quarter, with a goal of 40 sites by the end of next year [9][10] Company Strategy and Development Direction - The company is intentionally scaling by targeting world-class cancer centers to expand the use of hepcido into pipeline indications with larger patient populations [7] - Plans are underway to enter into the National Drug Rebate Agreement (NDRA) with the U.S. Department of Health and Human Services to increase market access [10][11] - The company is investing in further research and development for Hepsato, with preparations for trials in liver-dominant metastatic colorectal cancer and breast cancer [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to open sites, despite slower U.S. site activations, and adjusted full-year revenue guidance to $93 million to $96 million [10][12] - Management noted that the complexities of working with large institutions for a novel product are reflected in the pace of site openings [8][9] - The management team emphasized the importance of physician interest and patient outcomes as primary drivers for growth [36][70] Other Important Information - Research and development expenses for the quarter were $6.9 million, compared to $3.4 million for the same period in the prior year [17] - Selling, general, and administrative expenses for the second quarter were $11.4 million, compared to $6.8 million for the same period in the previous year [18] Q&A Session Summary Question: Insights on NDRA program and its impact on volumes - Management indicated it is premature to assess any tailwinds from the NDRA program, but noted that centers are pleased with the participation [20][21] Question: Update on sales team expansion - The expansion of the sales team is complete, with six regions now staffed with dedicated personnel for clinical support and site management [24][25] Question: Long-term volume potential with NDRA - Management discussed the potential for increased volume but emphasized the difficulty in quantifying the impact of the NDRA program [28][30] Question: Urgency from centers post-NDRA - Management noted no increased urgency from centers to activate, as many factors still influence the approval process [35][36] Question: R&D spending outlook - R&D expenses are expected to increase significantly in the coming quarters as trials ramp up [37][38] Question: ESMO presentation capacity - Management confirmed that MSLs will be able to discuss the outcomes of the CHOPEN trial at the ESMO conference [42][43] Question: Adjustments to active site guidance - The adjustment in active site guidance was due to the complexities of activating large academic centers [61][62] Question: Onboarding and training process improvements - Management is implementing strategies to streamline the onboarding process and improve training efficiency [75][79] Question: Impact of clinical programs on ChemoSAT sales - Long-term benefits for ChemoSAT sales are anticipated as new clinical sites open, but significant impacts will take time [82]