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]

Financial Data and Key Metrics Changes - The company reported a combined revenue of $19,800,000 for Hebsado and ChemoSATs in Q1 2025, with Hebsado sales in the U.S. contributing $18,000,000 and ChemoSATs in Europe adding $1,800,000, compared to $2,000,000 and $1,100,000 respectively in Q1 2024 [7][16] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [16] - Net income for Q1 2025 was $1,100,000, a significant turnaround from a net loss of $11,100,000 in Q1 2024 [17] - Positive adjusted EBITDA was reported at $7,600,000 compared to an adjusted EBITDA loss of $7,300,000 in Q1 2024 [17] - The company ended the quarter with approximately $59,000,000 in cash and investments and no debt [8][17] Business Line Data and Key Metrics Changes - The U.S. market for Hebsado and ChemoSATs showed strong growth, with a focus on expanding treatment centers, increasing from 17 to 19 active centers [8][9] - The average treatments per center per month were approximately two in Q1, with expectations to remain just under two for the remainder of the year [10][28] Market Data and Key Metrics Changes - The European market for ChemoSATs grew by 29% over the prior quarter to $1,800,000, although it is not expected to be a significant revenue contributor in the short to medium term due to reimbursement pricing challenges [11] - The company is focusing on generating clinical data from European sites, which have over a decade of experience with ChemoSATs [11][44] Company Strategy and Development Direction - The company aims to expand its active treatment centers to 30 by year-end, with a current pace of opening three to five centers per quarter [9][10] - The strategic focus includes leveraging cash from operations to support research and development initiatives for broader patient populations suffering from liver cancer [8][15] - The company is pursuing additional indications for Hepciddo, including metastatic colorectal and breast cancer, with ongoing clinical trials [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a more even distribution of center activations throughout the year, rather than a concentration in the second half [25] - The company anticipates that the ongoing engagement with oncologists and interventional radiologists will drive demand for treatments [15] - Management acknowledged the competitive landscape but emphasized the collaborative nature of information sharing among treatment centers [38] Other Important Information - The company has implemented a patient access program to assist with copay costs and connect patients with treatment centers [10][53] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [44] Q&A Session Summary Question: Update on center activations - Management indicated that the pace of center activations may be more even throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [25][26] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with total operating expenses projected to rise by 60% over 2024, while maintaining positive EBITDA for the year [30][31] Question: Frequency of patient treatments - The average frequency of treatments for patients is expected to remain around 4.1, which is a key driver for overall revenue [36] Question: European market growth and reimbursement - Management noted that while European revenues are increasing, reimbursement challenges remain, and they are focusing on generating clinical data before investing more resources [40][44] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not found suitable opportunities yet [70][72]