2seventy bio(TSVT) - 2022 Q4 - Annual Report

Financial Performance - The company reported net losses of $254.2 million, $292.2 million, and $120.1 million for the years ended December 31, 2022, 2021, and 2020, respectively[467]. - Total revenue for the year ended December 31, 2022, was $91.5 million, a 67.9% increase from $54.5 million in 2021[527]. - Selling, general and administrative expenses decreased to $79.5 million in 2022, down 15.1% from $93.5 million in 2021[530]. - Net loss for the year ended December 31, 2022, was $254.2 million, an improvement of 13.0% compared to a net loss of $292.2 million in 2021[538]. Cash and Financing - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $267.7 million[469]. - The company expects its cash resources to be sufficient to fund operations for at least the next twelve months, including ongoing commercialization of Abecma[469]. - Net cash used in operating activities was $237.1 million for the year ended December 31, 2022, compared to $207.0 million in 2021[540]. - Net cash provided by financing activities was $166.2 million in 2022, primarily from the issuance of common stock[545]. - The company may pursue additional cash resources through public or private equity offerings, debt financings, and strategic collaborations[468]. Research and Development - The company is advancing multiple clinical programs, including SC-DARIC33 for pediatric patients with relapsed and refractory acute myeloid leukemia and bbT369 for patients with B-cell non-Hodgkin lymphoma[466]. - Research and development expenses are expected to be driven by advancing SC-DARIC33 and bbT369 clinical programs, funding Abecma development, and manufacturing clinical study materials[483]. - Total direct research and development expenses for 2022 were $248.735 million, a decrease of 1.5% from $252.617 million in 2021[486]. - The ide-cel program incurred $45.896 million in expenses in 2022, down from $71.958 million in 2021, representing a 36.2% decrease[486]. - The bbT369 program expenses increased to $29.256 million in 2022 from $20.172 million in 2021, marking a 45.1% increase[486]. Revenue Recognition - The company has not recognized any revenue from product sales directly, with all revenue derived from collaboration arrangements with BMS[473]. - Collaborative arrangement revenue for the year ended December 31, 2022, was $32.358 million, compared to $26.921 million in 2021 and $115.594 million in 2020[510]. - The U.S. Abecma collaboration with BMS generated $12.781 million in revenue for 2022, down from $19.425 million in 2021[510]. - The company recognized collaborative arrangement revenue net of share of collaboration loss of $3.1 million for 2022, down from $9.4 million in 2021[512]. Operational Developments - The company anticipates its drug product manufacturing facility in Cambridge, Massachusetts, to be operational by mid-2023, which will support future Phase 1 clinical trials[467]. - The company has operationalized drug product manufacturing capabilities at its Cambridge headquarters to support clinical trials and preclinical development activities[552]. - The company has initiated clinical studies for the bbT369 and SC-DARIC33 programs in the first quarter of 2022, presenting these programs separately in financial disclosures[486]. Future Obligations and Commitments - As of December 31, 2022, future contingent cash payments related to commercial milestones were estimated at $99.9 million, with a fair value of $2.2 million[493]. - The company has obligations to make future payments to third parties upon the achievement of certain development, regulatory, and commercial milestones, which are not yet recorded in financial statements[561]. - Under a license agreement with Biogen Inc., the company may be obligated to pay up to $23.0 million in aggregate for each licensed product upon the achievement of remaining milestones[562]. Market and Economic Conditions - The company is currently not exposed to significant market risk related to foreign currency exchange rates but is evaluating the costs and benefits of initiating a hedging program for future international operations[571]. - Inflation has not materially affected the company’s business or financial condition during the year ended December 31, 2022, but there may be future impacts on clinical trial costs and labor expenses if inflation rates rise[572].