bluebird bio, Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Bluebird Bio third quarter 2023 results 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 at any time, please press star 1-1 on your telephone keypad. If your question has been answered and you wish to remove yourself from the queue, simply press star 1-1 again. At this time, I would like to turn the conference over to your host, Ms. Courtney O'Leary. Ma'am, please begin.

Good morning, everyone, and thank you for joining our third quarter results call today. My name is Courtney O'Leary, Director of Investor Relations at Bluebird Bio. 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 expectations regarding our future financial results and financial position, in addition to statements of the company's plans, expectations or intentions regarding regulatory progress, commercialization plans, and business operations. 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. On today's call, Andrew Obenshain, our CEO, is going to provide some opening remarks on our overall business and potential Lobosel approval. Then Tom Klima, Chief Commercial and Operating Officer, will discuss the positive momentum in our Zanteglo and SkySona commercial launches, as well as launch preparations for Lobosel. And finally, Chris Krawcheck, Chief Financial Officer, will provide some color on our financial results before opening the call up for Q&A. With that, I will turn it over to Andrew.

Thanks, Courtney. And thank you, everyone, for joining our call this morning. I'm excited today to update you on Bluebird's Q3 results and our preparations for the potential upcoming FDA approval of LovaCell. This has been a transformative year for the field of gene therapy and for Bluebird Bio. We validated the commercial model for gene therapy with our Zanteglo and SkySona launches. And as a reminder, Bluebird occupies a unique strategic position as one of the only standalone commercial gene and cell therapy companies with an extensive platform of gene therapy expertise that will potentially enable growth, profitability, and expansion for years to come. And we are at an incredibly exciting moment for our company, but most importantly for patients as we approach the potential FDA approval of LovaCell for sickle cell disease in December. In a minute, Tom and Chris are going to provide more details on our commercial launches and financials, but I want to focus my comments this morning on LovaCell as we approach this key regulatory milestone. We are six weeks away from our LovaCell PDUFA date of December 20th. This potential approval will be a significant moment for the sickle cell disease community, a major milestone for our company, and if approved, will be the main driver of profitability for Bluebird for years to come. The review remains on track, and our team remains confident in the robustness and maturity of our BLA package for individuals 12 and older with sickle cell disease and a history of vaso-occlusive events, or VOEs. We believe the fact that an FDA advisory committee wasn't requested for LogoCell is a testament to the breadth and the depth of the LogoCell data, significantly more than any other gene therapy program for sickle cell disease. Additionally, this is the third lentiviral vector gene therapy that the FDA has reviewed from Bluebird, and thus a technology they are very familiar with. Our lentiviral vector technology is also uniquely traceable, giving us an unrivaled understanding of our therapies and the ability to conduct rigorous monitoring. We understand it can measure how we modify the cell and monitor effects over time. Last week, we announced that in early December, we will be presenting long-term follow-up data from our Zynteglo and LogoCell programs at the 65th ASH annual meeting, with an unparalleled up to nine years of follow-up in transfusion-dependent beta-thalassemia and five years of follow-up in our sickle cell disease program. We continue to progress plans for our anticipated LogoCell commercial launch in early 2024 following its potential FDA approval. With that, I will turn it over to Tom to highlight how our launches are progressing.