On January 11, 2021 -bluebird bio, Inc. (Nasdaq: BLUE) reported its intent to separate its severe genetic disease and oncology businesses into differentiated and independent publicly traded companies (Press release, bluebird bio, JAN 11, 2021, View Source [SID1234573840]). bluebird bio, Inc. will retain focus on severe genetic disease (SGD) and will launch its oncology business ("Oncology Newco") as a new entity. bluebird bio’s Board of Directors approved the intent to separate into two companies and it is anticipated that the spin out of Oncology Newco is to be tax-free to shareholders, subject to receipt of a favorable Internal Revenue Service (IRS) ruling.
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Upon completion of the separation, current chief bluebird, Nick Leschly, will lead Oncology Newco as Chief Executive Officer and will take on the role of Executive Chair for bluebird bio, Inc. Current President of the SGD business, Andrew Obenshain will continue his leadership as Chief Executive Officer of bluebird bio, Inc. Further, current Chair of bluebird’s Board of Directors, Daniel Lynch, will become Chair of the Board for Oncology Newco.
"We are excited and energized to begin this new year with so much opportunity ahead. Over the last decade, bluebird bio has pioneered development of gene and cell therapies for severe genetic diseases and oncology – delivering transformative outcomes for patients. Through the tenacity and incredible work of our bluebirds, our first commercial product is now approved in Europe and we are now on the cusp of several potential product approvals with a strong pipeline of earlier oncology research candidates on the horizon. This is a position few biotech companies have been able to attain," said Nick Leschly, chief bluebird. "After careful strategic review, it is clear to us that the two businesses are best served by independent leadership and teams to drive distinct strategic and operational objectives. Specifically, we believe it is the right time to double down on the respective businesses to fully enable and optimize the continued innovation, development and deployment of transformative gene and cell therapies for the patients we serve."
"In close collaboration with the Board of Directors, bluebird bio leadership has conducted a thorough assessment of the business overall and examined a range of options for the future," said Daniel Lynch, Chair of bluebird bio’s Board of Directors. "Based on this review, we collectively believe this strategic decision is in the best interest of patients, employees, investors and other stakeholders. We are committed to working together through this transformative process to ensure each company is optimized with the right teams in place for progressing these therapies through the regulatory process into commercialization, harnessing the power of the pipeline to continue creation of innovative medicines, establishing and rapidly growing product revenue, and creating value for shareholders."
Launching Severe Genetic Disease and Oncology for Bold Futures
bluebird bio intends to ensure both SGD and Oncology Newco are established as independent organizations with enhanced therapeutic focus and strong financial foundations. The company believes this approach will provide both entities with the ability to achieve the following:
Enhanced resource allocation and capital considerations for each company
Therapeutic expertise and focus to more effectively execute and deliver on milestones
Streamlined and simplified operations
Tailored investment theses to attract an appropriately suited shareholder base
Sustained patients first culture and innovation mindset
Increased strategic flexibility
By establishing this foundation in two new environments, the company believes each entity will be in a stronger position to deliver on their goals:
Severe Genetic Disease
Focus on delivery of Core 3 therapies in β-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the United States and Europe
Expand access and reimbursement for our commercial product, ZYNTEGLO (betibeglogene autotemcel), in Europe
Increase addressable patient populations through geographic expansion, label expansions, and product profile enhancement
Build on our expertise in gene therapy manufacturing through commercialization, significant process enhancements, and next generation technologies
Continue to explore innovative tools and technologies to ultimately bring these transformative medicines to more patients
Oncology Newco
Support commercial success of investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel), in multiple myeloma and continued development of investigational bb21217 product candidate; advancing into earlier lines and continuing to innovate
Deliver on the oncology pipeline of cellular therapies with a focus on non-Hodgkin’s lymphoma, acute myeloid leukemia, next-generation multiple myeloma and solid tumors
Advance next generation product cycling engine designed to rapidly build, test, learn and improve with an overarching goal of 1-2 investigational new drugs (INDs) in each of 2021 and 2022
bluebird bio Adds Additional Oncology Expertise to Board of Directors
As bluebird bio continues to build out therapeutic expertise within its Board of Directors, the company has appointed Ramy Ibrahim, M.D. to its Board of Directors. Dr. Ibrahim is a recognized leader in clinical development in immunotherapy and cell therapy. He is currently serving as a consultant for the Parker Institute for Cancer Immunotherapy (PICI) where he was recently the Chief Medical Officer and built the clinical capabilities within the institute as well as worked with renowned cell therapy experts to support building world class cell therapy startups. Before joining PICI, Dr. Ibrahim was the vice president and Global Therapeutic area head for Immuno-Oncology clinical development for AstraZeneca/MedImmune, leading the global clinical team developing multiple immunotherapies. In addition, as a member of the Bristol-Myers Squibb Immuno-oncology program, he served on the Yervoy (ipilimumab) clinical team supporting the program from early phase II through multiple global launches of the first FDA-approved immune checkpoint inhibitor. In addition to his engagement with investment firms, Dr. Ibrahim also serves on the Scientific Advisory Board of Harpoon and on the Board of Directors for Surface Oncology.
bluebird bio also acknowledges the significant and impactful contributions of Dr. David Schenkein, who after eight years, is stepping down from the bluebird bio Board of Directors.
Financial Summary
bluebird bio preliminary and unaudited cash, cash equivalents and marketable securities balance as of December 31, 2020 was approximately $1.3B. At the time of separation, bluebird bio plans to capitalize each business with sufficient cash runway to achieve value creating milestones. In preparation for the separation, bluebird bio will continue to prudently and carefully manage the cost structure of each business while evaluating dedicated financial and strategic funding sources. bluebird bio expects to incur increased transactional and separation expenses through the completion of the transaction as it works to separate and transition the two businesses. bluebird bio will provide additional financial details closer to the date of separation.
Transition and Timing
Specific details regarding the companies including financial statements, the name of Oncology Newco as well as executive management teams and the respective Board of Directors (BOD) for each company will be provided at a later date. Expected executive team, employee and BOD transitions will be effective as of the closing of the separation anticipated to be in the Q4 2021 timeframe. bluebird bio anticipates both companies will be headquartered in Cambridge, Mass. European operations will remain with bluebird bio and the SGD business. Facilities, research and manufacturing operations in Seattle, Wash. and Durham, N.C. will migrate with the Oncology Newco. The separation is subject to customary closing conditions, including the effectiveness of a Form 10 registration statement with the U.S. Securities and Exchange Commission, receipt of a private letter ruling from the IRS and tax opinion from counsel, and final approval by bluebird bio’s Board of Directors. There can be no assurance regarding the ultimate timing of the separation or that the separation will ultimately occur.
Goldman Sachs & Co. LLC is serving as exclusive financial adviser to bluebird bio and Goodwin Procter LLP is serving as its legal counsel.
Webcast Information
bluebird bio will hold a conference call to discuss the news on Monday, January 11 at 8:00 a.m. ET. Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 225-6277.
In addition, members of the management team will participate in the 39th Annual J.P. Morgan Healthcare Conference, Monday, January 11 at 2:50 p.m. ET.
To access the live webcast of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcast will be available on the bluebird bio website for 90 days following the event.