Atara Biotherapeutics(ATRA) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Atara Biotherapeutics reported a cash position of approximately $102 million as of September 30, 2023, which is expected to fund operations into Q3 2025 [11] - The strategic restructuring is anticipated to reduce planned cash expenditures by approximately 40% or $100 million by the end of 2025 [10] Business Line Data and Key Metrics Changes - The expanded partnership with Pierre Fabre Laboratories for tab-cel is expected to generate up to $640 million in additional consideration, including $30 million at deal closing and $100 million in potential regulatory milestone payments [8][9] - Tab-cel is projected to have U.S. peak sales potential of over $500 million per year following potential label expansion [10] Market Data and Key Metrics Changes - The partnership with Pierre Fabre aims to commercialize tab-cel in the U.S. and other global markets, leveraging their successful launch experience in Europe [7][8] - The pricing potential for tab-cel is based on its value for patients and healthcare systems, with a listed price in Europe of approximately $640,000 [28] Company Strategy and Development Direction - Atara is transitioning to focus on developing innovative allogeneic T cell therapies for cancer and autoimmune diseases, with a strategic restructuring that includes a 30% workforce reduction [10][11] - The company is prioritizing clinical development for ATA188 and ATA3219, with anticipated clinical milestones in the near term [6][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming EMBOLD data readout for ATA188, which is expected to provide insights into its potential impact on progressive multiple sclerosis [14][20] - The company is optimistic about the regulatory process for tab-cel, with a BLA submission expected in Q2 2024 [12][46] Other Important Information - The partnership with Pierre Fabre is seen as a pivotal transition for Atara, allowing the company to focus on its pipeline while reducing cash burn [7][10] - Atara is exploring the potential of CAR-T therapies for autoimmune diseases, indicating a broader application of their technology beyond oncology [18][19] Q&A Session Summary Question: Rationale for choosing Pierre Fabre as a partner - The decision was based on financial aspects, commitment level, and the ease of managing a single partner [22][24] Question: Breakdown of the $500 million peak sales potential - The peak sales figure is linked to various indications, with a significant portion expected from the first indication of EBV+ PTLD [25][28] Question: Update on the tab-cel regulatory process - New clinical data will be included in the BLA submission, with a focus on cleaning and analyzing data from the pivotal ALLELE study [30][32] Question: Commercial plans for ATA188 - Future plans may involve strategic co-development partnerships, particularly in the U.S. market [34][37] Question: Magnitude of royalties from Pierre Fabre - The agreement includes significant double-digit tiered royalties, but specific details cannot be disclosed [39] Question: Go/no-go decision criteria for EMBOLD data - A significant statistical result or strong trend supported by additional clinical measures could lead to advancing into Phase III trials [40][43]