Workflow
bluebird bio(BLUE)
icon
Search documents
bluebird bio(BLUE) - 2020 Q3 - Quarterly Report
2020-11-04 21:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ FORM 10-Q __________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Num ...
bluebird bio(BLUE) - 2020 Q2 - Quarterly Report
2020-08-05 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 par value per share BLUE The NASDAQ Stock Market LLC FORM 10-Q __________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 ...
bluebird bio(BLUE) - 2020 Q1 - Earnings Call Transcript
2020-05-12 02:04
Financial Data and Key Metrics Changes - The company has made significant adjustments to its operating plan, removing over $500 million from its operating budget through mid-2022, which extends its financial runway while maintaining core programs [10][20][24] - The revised operating plan aims to balance innovation with financial sustainability, focusing on delivering core programs by 2022 and securing non-dilutive funding [20][21] Business Line Data and Key Metrics Changes - The company submitted a US Biologics License Application (BLA) for ide-cel for late-stage multiple myeloma treatment, with plans for a data presentation at the virtual ASCO meeting [8][18] - For sickle cell disease, the company reached alignment with the FDA on an accelerated approval path for LentiGlobin, planning to file for approval in the second half of 2021 [9][17] Market Data and Key Metrics Changes - The company is actively engaging with European authorities for the sickle cell opportunity, aiming to ensure access to data and finalize requirements for regulatory approval [66] - The company anticipates the first commercial patients for ZYNTEGLO in Germany later this year, with ongoing reimbursement discussions in other EU markets [70] Company Strategy and Development Direction - The company is focused on delivering transformative products while maintaining a strong operational foundation, emphasizing the importance of culture and innovation [11][20] - The revised collaboration with Bristol-Myers Squibb (BMS) includes a $200 million non-dilutive funding agreement, enhancing operational flexibility and aligning manufacturing responsibilities [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the challenges posed by the COVID-19 pandemic, highlighting the resilience and adaptability of the team [7][12] - The company remains committed to its long-term vision while adapting to the current economic landscape, ensuring that core values and innovation are preserved [11][20] Other Important Information - The company plans to present updated clinical data for Lenti-D for CALD at a medical meeting later this year, with regulatory filings in the EU planned for this year and in the US next year [19] - The company is prioritizing the core four late-stage programs while optimizing operational resources to ensure sustainability [20][24] Q&A Session Summary Question: What does "general agreement" mean regarding the sickle cell path? - Management clarified that "general agreement" refers to a legal categorization and does not change the agreements with the FDA, confirming that the filing will be based on HGB-206 data, not HGB-210 [28][29] Question: How does the $200 million correlate with the ex-US opportunity for bb2121? - Management expressed confidence that the deal reflects significant value and aligns operational responsibilities, ensuring a sensible split of resources [32][34] Question: What are the gating items on manufacturing related to FDA for sickle cell? - Management indicated that clinical alignment and manufacturing transitions are well underway, with ongoing discussions to ensure readiness for regulatory timelines [48][50] Question: Why is HGB-210 necessary as a post-approval confirmatory study? - Management explained that HGB-210 serves as a classic post-approval confirmatory trial to provide additional follow-up data for full approval [58] Question: What is the expected timeline for the sickle cell filing? - Management anticipates submitting the BLA in the second half of 2021, with a focus on complete resolution of severe vaso-occlusive events as the primary endpoint [17][55]
bluebird bio(BLUE) - 2020 Q1 - Quarterly Report
2020-05-11 11:40
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ FORM 10-Q __________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: ...
bluebird bio(BLUE) - 2019 Q4 - Annual Report
2020-02-18 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ___________________________________________________________________________ FORM 10-K ___________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...