Summary of Bristol-Myers Squibb Company (NYSE:BMY) FY Conference Call - September 23, 2025 Company Overview - **Company**: Bristol-Myers Squibb Company (BMY) - **Focus**: Cell therapy, particularly in hematology and autoimmune diseases Key Points and Arguments Cell Therapy Potential - Bristol-Myers Squibb has been involved in cell therapy for four years, launching the first CAR T in multiple myeloma and the third CD19 CAR T [2][3] - The company has treated 13,000 patients, gaining significant clinical and translational data, which has accelerated its pipeline [3] - Current assets include Orva-cel (GPRC5D) and Breyanzi (CD19), both showing promise for durable remissions with a one-time infusion [4][5] Market Dynamics and Challenges - The healthcare system has limited the uptake of CAR T therapies compared to expectations from a decade ago, with only 2 out of 10 eligible patients currently receiving CAR T [16][17] - Community practices treat 70% of patients, and there is a need for better integration of CAR T therapies into these settings [10][11] - Recent reductions in patient burden and REMS (Risk Evaluation and Mitigation Strategy) requirements are expected to improve access and referrals [10][11] Competitive Landscape - Breyanzi has become the number one CD19 CAR T in the U.S., Germany, Japan, and France, attributed to its best-in-class profile and broad indications for B-cell malignancies [14][15] - The company anticipates growth in outpatient settings due to Breyanzi's safety profile, allowing for home monitoring post-infusion [15][16] Innovation and Future Directions - Bristol-Myers Squibb is exploring both autologous and allogeneic CAR T therapies, with a focus on off-the-shelf solutions for broader patient access [22][23] - The company is excited about the potential of GPRC5D in multiple myeloma, especially for patients who are quad-class exposed [27][28] - The dual-targeting approach aims to address the high unmet need in newly diagnosed multiple myeloma patients [37][38] Regulatory Environment - The FDA's current stance has not changed significantly, and the company expects to replicate promising efficacy and safety profiles in upcoming trials [33][35] Long-term Vision - Bristol-Myers Squibb aims to deliver CAR T therapies to over 100,000 patients, expanding into diseases previously thought untreatable [60][61] - The company is committed to creating an ecosystem that facilitates access to CAR T therapies, particularly in rheumatology [55][58] Additional Important Insights - The potential market for CAR T in autoimmune diseases is significantly larger than in hematology, with a three to five times larger patient population [43][44] - The company is actively working to educate and create partnerships among rheumatologists and hematologists to improve patient access to CAR T therapies [55][56] - The excitement around CAR T therapies is palpable, with patients expressing regret for not receiving treatment sooner [19][46] This summary encapsulates the key discussions and insights from the Bristol-Myers Squibb conference call, highlighting the company's strategic focus on cell therapy and its commitment to addressing patient needs in hematology and autoimmune diseases.

Summary of the Conference Call on Cell Therapy and Autoimmune Diseases Industry Overview - The discussion focuses on the emerging field of cell therapy, particularly T cell engagers and CAR T therapies, and their applications in treating autoimmune diseases alongside oncology applications [1][2]. Key Companies and Their Innovations Cullinan - Cullinan is exploring T cell engagers to redirect T cells for depleting aberrant immune cells, particularly B cells, in autoimmune diseases [3]. - The company aims to make T cell redirecting therapies accessible in community-based centers, enhancing patient access [3]. Autolus - Autolus has launched a CD19 CAR T product approved for acute leukemia, demonstrating a strong safety profile and exceptional activity, leading to long-term remissions in advanced disease patients [4][5]. - The company is also looking to expand into the autoimmune space, believing that their product's features will be beneficial [6]. Caballetta - Caballetta focuses on developing cellular therapies specifically for autoimmune diseases, with their lead product ResiCel entering phase three trials for myositis [9][10]. - The company has agreements with the FDA for multiple cohorts in various trials, targeting diseases like lupus and multiple sclerosis [11]. Core Insights and Arguments - The panelists agree on the significant unmet need in autoimmune diseases and the potential for their therapies to provide meaningful clinical advances [8]. - T cell engagers have shown promise in achieving disease-modifying benefits, with reports indicating deep B cell depletion and symptom improvement in treated patients [14][15]. - The safety profile of these therapies is emphasized as a key differentiator in a market with high unmet needs [11][12]. Clinical Development and Regulatory Pathways - The discussion highlights the importance of understanding patient subtypes and tailoring treatment strategies based on disease severity and pathology [41]. - There is a consensus that the regulatory path for T cell engagers may differ from traditional drug approvals, with a focus on therapeutic benefit and safety [63][64]. Market Dynamics and Future Outlook - The panelists predict a competitive landscape in the autoimmune therapy market, with multiple modalities coexisting rather than competing fiercely [13]. - The potential for bispecific therapies to transform treatment paradigms is acknowledged, with expectations for improved efficacy and safety profiles [32][38]. - The market for autoimmune therapies is seen as distinct from oncology, with different pricing and patient demographics influencing market strategies [30][31]. Additional Considerations - The importance of biomarkers in identifying suitable patients for different therapies is highlighted, with ongoing research expected to refine patient selection [25][41]. - The need for collaboration between hematologists and rheumatologists is emphasized to facilitate patient enrollment in clinical trials [58][61]. This summary encapsulates the key points discussed during the conference call, providing insights into the current state and future potential of cell therapies in treating autoimmune diseases.