bluebird bio, Inc.

Steps must be coordinated, and the patient's health must be considered. With that in mind, we continue to anticipate SARS-CoV-2 to grow quarter over quarter, with the majority occurring in the second half of the year as momentum builds. And factoring in the time for drug product manufacturing once the patient's cells are collected, we anticipate that first revenues for Lefgenia will be reported in Q3. Moving to Zanteglo. We continue to see strong linear growth with 11 patient starts since the beginning of 2024. As we previously shared in mid-2023, we initiated steps to increase drug product manufacturing capacity for Zyntegra and SkySona commensurate with demand. Through our experience in the market, we have also determined the need to increase adherent vector supply, and we've initiated steps to bolster supply to meet the launch trajectory. Additionally, we have completed three patient starts for SkySona since the beginning of 2024. As a reminder, patient starts, which is when cell collection occurs, remain the key commercial metric to watch in the early stages of our launch, as this is the value-creating moment for the company, with revenue being recognized when the patient is infused. For modeling purposes, you can continue to expect that patients are infused one to two quarters following cell collection. In our experience, once a patient goes through cell collection, they continue on the treatment journey and are dedicated. To date, every patient who has started the process has completed or remained in the process, and we continue to expect between 85 and 105 patient starts across our commercial portfolio in 2024. Now moving to access and reimbursement. Our validated strategy from our Synteglo and SkySona experience is driving favorable coverage for Lefgenia. We are very pleased to have our cost-effectiveness model for Lefgenia peer-reviewed and published in the Journal of Pharmacoeconomics in April. The publication offers significant insight into the potential lifetime impact that reducing or eliminating DOE-associated pain crises may have on patients' health and well-being, healthcare utilization, future earnings, and life opportunities. The publication found that Lipgenia is cost-effective up to a price of $3.9 million. The value is being recognized, and we are making great progress securing access for patients with sickle cell disease. Just five months post-launch, both commercial and Medicaid-insured patients have successfully obtained prior authorization for Lipgenia. Additionally, we have multiple outcomes-based agreements signed for Lipgenia with national commercial payoff organizations and have published coverage policies in place for more than 200 million U.S. lives. Our goal has always been timely, equitable access to Lefgenia, irrespective of a patient's insurance type. Discussions are ongoing with Medicaid agencies representing 80% of Medicaid-insured individuals with sickle cell disease in the U.S. Additionally, timely access to Zantaglo and SkySona has continued, with zero ultimate denials for either therapy across both Medicaid and commercial payers. Moving to our QTC network, we have established a substantial QTC footprint very quickly following Livgenia's approval. Today, Bluebird has activated 64 QTCs for Livgenia and Zinteglo. We were able to quickly transition these centers for Livgenia due to both the learned experience of setting up these centers for Zinteglo and the strong relationships we've built with these centers during 2023. 11 QTCs have started their first patient for one of our products, and the majority of sites who have started their first patient have started their second or third. While we anticipate we may bring on a handful of additional centers throughout 2024, our focus has shifted to patient pull throughout our 64 centers and deepening their experience with Bluebird's gene therapy portfolio. Additionally, six centers in our network are also activated to administer SkySona for patients with CALD. To recap, Zenteglo and SkySona launches continue to progress as planned, and we anticipate strong linear growth for Zenteglo in 2024, along with 5 to 10 patient starts for SkySona. We are extremely excited about the early progress in our Lifgenia launch, building on our validated commercial platform, and most importantly, gene therapy is becoming a reality for patients in the United States. We look forward to updating you as our momentum builds in our launches and patient stress grow over the next few quarters. And now I would like to turn the call over to Chris.

Thanks, Tom, and good morning, everyone. In the first quarter, we reported $18.6 million in total revenue, driven by revenue from Zynteglo. As a reminder, we recognize revenue upon infusion of the drug product. As previously guided in 2024, we anticipate gross net discounts in the range of 20% to 25% with fluctuations based on product mix, payer mix, as well as utilization of our outcomes-based agreements. As of March 31, 2024, we had $264 million in cash on hand, inclusive of $52 million in restricted cash. Based on our current business plans, including our ability to achieve certain commercial revenue milestones, we have a cash runway through Q1 of 2026. This runway includes our current cash equivalents, and also assumes that we receive the two remaining tranches totaling $50 million from our term loan facility. Additionally, we continue to work expeditiously to complete our restatement and file our 2023 10-K and Q1 2024 10-Q. I want to personally thank and recognize the tremendous work and unwavering dedication of the Bluebird finance and accounting teams that are finalizing the restatement. Importantly, and as a reminder, the restatement is not expected to impact our cash position or our revenue. With that, I'll turn it back over to Andrew. Thanks, Chris.

As we highlighted today, it's an exciting time for Bluebird. We stand in the midst of a monumental year with the potential for growth on the near-term horizon. And with that, I'd like to open it up for questions. Operator?