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2seventy bio Inc. reports developments centered on Abecma, its FDA-approved CAR T cell therapy for multiple myeloma, and the U.S. collaboration with Bristol Myers Squibb. News commonly covers Abecma commercialization, regulatory and clinical updates, KarMMa study decisions, collaborative arrangement revenue, operating results, cash position, cost management, material agreements, capital-structure disclosures and governance matters.
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Bristol Myers Squibb (BMY) reported first quarter revenues of $11.3 billion, a decline of 3% year-over-year, impacted by generic erosion of Revlimid. Adjusted for foreign exchange, the revenue decrease was 1%. The company posted a GAAP earnings per share (EPS) of $1.07, an 81% increase from $0.59 in the prior year, while non-GAAP EPS was $2.05, a 5% rise from $1.96. Revenue from in-line and new products grew 8% to $9.3 billion, or 10% when excluding foreign exchange impacts. The U.S. revenues improved 4% to $8.0 billion. Bristol Myers also adjusted its GAAP EPS guidance for 2023 while affirming its non-GAAP guidance, indicating resilience in its operational strategy despite external pressures.
The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for Bristol Myers Squibb (NYSE:BMY) and 2seventy bio's Abecma (idecabtagene vicleucel), with a target action date set for December 16, 2023. This application is based on promising interim results from the Phase 3 KarMMa-3 study, which demonstrated a significant reduction in disease progression or death for patients with relapsed and refractory multiple myeloma compared to standard treatments. Additionally, the European Medicines Agency validated a Type II variation application for Abecma, and Japan's Ministry of Health accepted the supplemental New Drug Application. These developments highlight the commitment to enhance treatment options for multiple myeloma patients.
2seventy bio, Inc. (TSVT) reported its financial results for Q4 2022, with U.S. revenue from Abecma reaching $94M for the quarter and $297M for the full year. The company forecasts U.S. revenue of $470-$570M in 2023, supported by positive Phase 3 KarMMa-3 study results. As of December 31, 2022, 2seventy bio held $267.7M in cash and equivalents, with a projected net cash spend of $180-$220M for 2023. Following a $117M equity offering in early 2023, the company expects a cash runway into 2026, allowing further advancement of its pipeline, including potential FDA submissions and collaborations with Regeneron.