Immunocore(US:IMCR)2023-08-10 17:26Financial Data and Key Metrics Changes - Net KIMMTRAK revenue increased to $57.8 million in Q2 from $52 million in Q1, representing an 11% quarter-over-quarter growth and a year-to-date revenue of $111 million [7][22][46] - The net loss for the period was approximately $18 million, with SG&A expenses year-to-date around $60 million [8][49] - The cash position of the company increased to $435 million, driven by KIMMTRAK revenue and disciplined expense management [49] Business Line Data and Key Metrics Changes - KIMMTRAK sales in the U.S. saw a 14% demand growth, increasing first-line market share from approximately 50% in Q1 to 60% in Q2 [10][22] - The company launched KIMMTRAK in four additional countries, including Italy, Austria, Finland, and Israel, expanding its market presence [22] Market Data and Key Metrics Changes - KIMMTRAK is now approved in over 35 countries, with reimbursement agreements reached in Germany, expected to be published in September [20][22] - The company anticipates further growth in the U.S. and Italy, with plans to launch in additional European countries by the end of the year [23][64] Company Strategy and Development Direction - The company is committed to expanding its oncology pipeline, with plans to submit three INDs or CTAs over the next 18 months, starting with PIWIL-targeted candidates in Q4 [18][64] - The first Phase 3 trial for the PRAME-targeted therapy is set to begin by Q1 2024, focusing on advanced cutaneous melanoma patients [37][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing educational efforts to support KIMMTRAK therapy, which is expected to drive further growth [23] - The company remains focused on making KIMMTRAK available to over 1,000 patients per year by 2025 [25] Other Important Information - The company is exploring a less frequent dosing regimen for KIMMTRAK based on insights from clinical data, which may enhance patient compliance [80][102] - The company is also investigating the potential for a functional cure for HIV and HBV through ongoing clinical trials [18][65] Q&A Session Summary Question: Plans for Phase 3 in melanoma - Management confirmed that the decision to start the Phase 3 study was based on positive data from ESMO and ongoing expansion cohort data [40][41] Question: Market size comparison for gp100 versus PRAME - Management highlighted that the accessible market for PRAME in first-line treatment is greater than 10,000 patients per year, compared to 2,000 to 4,000 for KIMMTRAK in second-line treatment [73] Question: Efficacy changes based on Phase 2 data - Management indicated that the Phase 2 data could inform changes to the Phase 3 design, including potential discontinuation of less effective arms [79] Question: Less frequent dosing rationale - The decision for less frequent dosing was influenced by KIMMTRAK's experience and the observation that most progression occurs within the first 12 weeks of treatment [80][102] Question: Initial data expectations for HIV program - Management outlined that initial data will include safety and biomarkers during the first 12-week treatment period, followed by a virus rebound assessment after ART withdrawal [96]