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Mar 31, 2020
Bluebird Bio Q1 2020 Earnings Report
Reported financial results for the first quarter ended March 31, 2020 and provided an operational update.
Key Takeaways
Bluebird Bio reported its Q1 2020 financial results, highlighting an agreement with the FDA on the regulatory path for LentiGlobin for sickle cell disease and the submission of the ide-cel BLA with Bristol Myers Squibb. The company also amended its BMS collaboration, securing $200 million, and revised its operating plan to achieve over $500 million in cash savings through 2022, extending its cash runway into 2022.
Aligned with FDA on accelerated regulatory path for LentiGlobin for sickle cell disease, targeting submission in 2H 2021.
Completed submission with Bristol Myers Squibb of Biologics License Application (BLA) for idecabtagene vicleucel to FDA.
Amended BMS collaboration including $200 million monetization for ex-U.S. milestone and royalty revenue from idecabtagene vicleucel.
Revised Operating Plan achieves cash savings of over $500 million through 2022 and extends cash runway into 2022.
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird Bio is on track for potential regulatory approval and commercial launch for ZYNTEGLO, ide-cel, Lenti-D for CALD, and LentiGlobin for SCD by 2022.
Positive Outlook
- Potential regulatory approval and commercial launch for ZYNTEGLO by 2022.
- Potential regulatory approval and commercial launch for ide-cel by 2022.
- Potential regulatory approval and commercial launch for Lenti-D for CALD by 2022.
- Potential regulatory approval and commercial launch for LentiGlobin for SCD by 2022.
- ZYNTEGLO first commercial patients treated in Europe in the second half of 2020.
Challenges Ahead
- Expects the COVID-19 pandemic to shift the timing of enrollment and completion of clinical studies by at least three months and expects timing shifts to vary by clinical trial and by program.
- Risk that the COVID-19 pandemic and resulting economic conditions will have a greater impact on the company’s operations and plans than anticipated.
- Risk that the company will not be able to realize the savings under the revised operating plan or successfully execute the revised operating plan.
- Risk that our amended collaboration with BMS will not continue or be successful.
- Risk that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials.