bluebird bio, Inc.

Good morning, and thank you for standing by. Welcome to the Bluebird Bio conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you need to press star 1 on your telephone. I would now like to hand the conference over to your speaker today, Courtney O'Leary, Investment Relations. Please go ahead.

Good morning, everyone, and thank you for joining today's call to discuss this morning's restructuring announcement. The press release announcing these updates can be found on the investor relations section of our website. Before we begin, let me review our safe harbor statement. Today's discussion contains statements that are forward-looking under the Private Securities Litigation Reform Act of 1995, including our statements regarding potential cost savings from restructuring and the expected impacts on our operating expenses and cash runway. Such statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of risk factors that could cause actual results to differ materially from projected results. A description of these risks is contained in our filings with the SEC, which are available on the investor relations section of our website www.bluebirdbio.com. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so if our expectations change, except as required by law. You should not rely on these forward-looking statements as representing our expectations of any subsequent date to today. Today's agenda is as follows. Andrew Obenshain, our Chief Executive Officer, is going to provide some opening remarks and then Jason Cole, our Chief Strategy and Financial Officer, is going to discuss the restructuring announcement in greater detail. They will then be joined for Q&A by Tom Klima, our Chief Commercial Officer. Thank you for joining, and I will now turn it over to Andrew.

Thank you, Courtney, and good morning, everyone. I want to start and acknowledge that today is a tough yet important day for Bluebird. As announced this morning, we've initiated a comprehensive restructuring of our company, to focus on our near-term critical milestones. Making this decision was not easy. However, following a thorough review, we've concluded that our mission of ultimately bringing potentially curative gene therapies to patients and their families in the U.S. means that we need to think differently about our business and our strategy for the future. Going forward, we plan to focus on the near-term delivery of our three potential first-in-class therapies for beta thalassemia, for cerebral adrenal leukodystrophy, and for sickle cell disease. With this restructuring, we're taking action that is expected to extend our runway into the first half of 2023 and put ourselves in a stronger position to execute on our near-term priorities. Our focus is on a significant number of near-term catalysts to advance our three therapies through the anticipated approvals and into the commercial setting. Combined, the three programs, Betacel for beta thalassemia, LSL for cerebral adrenal leukodystrophy, and lovacil for sickle cell disease have the potential, if approved, to reach approximately 22,000 patients in the U.S. With a clear focus on our near-term catalysts, we've made a decision to deprioritize direct investment in cryopreserved aparesis and to deprioritize direct investment in reduced toxicity conditioning and to maintain a targeted research effort in in vivo LBV beginning in sickle cell disease with support from the Gates Foundation. Over more than a decade, Bluebird has been a pioneer in the field of gene therapy, making remarkable advances across research, across development, manufacturing, and regulatory affairs. And building on this progress, the company is preparing for the approval of its first lentiviral vector of gene therapy in the U.S. It has not been easy. Being one of the first in gene therapy means that we have also faced a uniquely challenging environment, navigating the precedent-setting nature of being a pioneer in this field. as we anticipate we'll introduce these novel therapies with expectation of lifelong benefit. Since the split in November, we've encountered a number of unanticipated hurdles. These include a partial hold for LovaCell, an extension of our BetaCell and LSL PDUFA goal dates, and then all this has been set against the backdrop of a tough biotech market. And the combination of these have taken some traditional financing options off the table in the near term. We are optimistic that these options may be viable sources of funding in the future, but we recognize the need for action today to put us in a stronger financial position to reach our near-term goal of bringing LVV gene therapy to patients. This is why we've made the very tough but necessary decision to reshape our business and our cost structure. Jason Cole, our Chief Strategy and Financial Officer and a seasoned Bluebird executive, is going to now discuss restructuring in greater detail.