bluebird bio(BLUE) - 2020 Q3 - Quarterly Report

Financial Position - As of September 30, 2020, the company had cash, cash equivalents, and marketable securities of approximately $1.44 billion[147]. - The company expects its current cash position to fund operations into 2023, assuming continued focus on expense management and exploration of additional funding sources[153]. - As of September 30, 2020, the company has $120.0 million in future contingent cash payments related to the acquisition of Precision Genome Engineering, with $20.1 million tied to clinical milestones and $99.9 million to commercial milestones[171]. Revenue Generation - The company has not generated any revenue from product sales to date, relying instead on collaboration arrangements and research fees[154]. - A one-time up-front payment of $200 million was received from BMS as part of an amended agreement related to ide-cel and bb21217[153]. - The company recognized $26.9 million in revenue from LentiGlobin for the three months ended September 30, 2020, compared to $26.5 million for the same period in 2019, indicating a slight increase[165]. - Total revenue for the three months ended September 30, 2020, was $19.3 million, an increase of $10.4 million from $8.9 million for the same period in 2019, primarily due to increased ide-cel license and manufacturing services revenue[176]. - Total revenue for the nine months ended September 30, 2020, was $240.0 million, an increase of $205.3 million from $34.7 million for the same period in 2019, largely due to a cumulative catch-up adjustment related to a contract modification[181]. - License revenue has historically been generated from out-license agreements, with potential future milestone payments and royalties recognized as revenue[158]. Expenses and Losses - The net loss for the three and nine months ended September 30, 2020, was $194.7 million and $418.8 million, respectively, with an accumulated deficit of $2.70 billion[147]. - The company expects to incur significant expenses and operating losses for at least the next several years due to ongoing clinical studies and commercialization efforts[147]. - The company anticipates an increase in selling, general and administrative expenses as it executes commercial launch plans for ZYNTEGLO in Europe and prepares for activities in the United States[167]. - Selling, general and administrative expenses for the three months ended September 30, 2020, were $68.0 million, an increase of $1.8 million from $66.3 million for the same period in 2019, primarily driven by increased consulting fees[178]. - Selling, general and administrative expenses for the nine months ended September 30, 2020, were $209.9 million, an increase of $14.8 million from $195.2 million for the same period in 2019, primarily due to increased employee compensation and IT-related costs[184]. Research and Development - The company reported total direct research and development expenses of $84.5 million for the three months ended September 30, 2020, compared to $93.5 million for the same period in 2019, reflecting a decrease of approximately 9.5%[165]. - Total research and development expenses for the nine months ended September 30, 2020, were $450.9 million, an increase of approximately 7.2% compared to $420.6 million for the same period in 2019[165]. - The company plans to continue investing in research and development for product candidates including beti-cel, eli-cel, and LentiGlobin, focusing on severe genetic diseases and oncology[163]. - Research and development expenses include costs associated with multiple ongoing clinical studies, such as the Northstar-2 Study and the KarMMa study, which are critical for advancing product candidates[163]. - The company has incurred research and development expenses related to various studies, including a total of $140.4 million for the three months ended September 30, 2020, compared to $151.4 million for the same period in 2019[165]. - Research and development expenses for the nine months ended September 30, 2020, were $450.9 million, an increase of $30.3 million from $420.6 million for the same period in 2019, driven by increased employee compensation and clinical trial costs[182]. Impact of COVID-19 - The COVID-19 pandemic has caused disruptions in clinical trials and manufacturing, impacting the company's operations and timelines[150]. - The company has prioritized key research and development programs in response to the COVID-19 pandemic, adjusting its future cost structure accordingly[152]. Market Risks - The company is exposed to market risk related to interest rates, with a hypothetical decline of approximately $6.8 million in the fair value of interest-sensitive marketable securities if rates increase by 100 basis points[195].