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bluebird bio, Inc.
3/26/2024
Good day, and thank you for standing by. Welcome to the Bluebird BIO fourth quarter and 2023 annual 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 during the session, you'll need to press star 11 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Courtney O'Leary, Investor Relations. Please go ahead.
Good morning, everyone, and thank you for joining our fourth quarter and 2023 annual 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, Bluebird Bio's CEO, will provide a general corporate update. And then Tom Klima, Chief Commercial and Operating Officer, will discuss progress on the commercial launches of Lifgenia, Zinteglo, and SkySona. And finally, Chris Krawchuk, Chief Financial Officer, will provide a financial update 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 as we provide an update on our fourth quarter of 2023 and the results and discuss our strategic outlook and plan milestones for 2024. Earlier this morning, we put out an 8K announcing that we will be restating financial information for 2022 and for the first three quarters of 2023, and that we've submitted an extension on our 10-K filing. We now anticipate filing the 10-K, inclusive of that restatement, no later than April 16th. Importantly, the restatement does not impact our cash position or revenue. Chris will discuss this in greater detail later in the call. 2023 was a year of significant progress for Bluebird. We established ourselves as a commercial gene therapy leader with a validated commercial strategy that brought both Zanteglo and Skysona to patients across the U.S. Our recent commercial progress for Lithgenia builds on that foundation. With the FDA approval of Lithgenia for sickle cell disease last December, Bluebird is currently the only commercial gene therapy company with three FDA-approved products. Since then, our commercial team has hit the ground running, position ourselves for a strong Lithgenia launch. We have talked before about the benefits of our significant commercial head start with Centeglo, and today we are seeing the fruits of that labor translate into real momentum for Lithgenia. We have activated 62 qualified treatment centers and have signed our first outcomes-based agreement for Medicaid, extending access to Lithgenia to this critical patient population. And 2024 is also a fast start with nine patient starts already this year. Tom will dive deeper into our commercial progress momentarily. Last week, we also announced that we entered into a five-year term loan with Hercules Capital for up to $175 million. This transaction provides a bluebird with an infusion of capital that is expected to extend our cash runway beyond the next 24 months. Last August, on our Q2 earnings call, we set out a five-year vision for Bluebird as a standalone commercial gene therapy company. We outlined our near-term path to profitability and our expected additional growth and scale over the next five years. This funding forwards that vision to capitalize on the multi-billion dollar opportunity in front of us in the U.S. I will now hand the call over to Tom to highlight the significant progress happening in our commercial launches.
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