bluebird bio Reports First Quarter 2024 Results and Highlights Operational Progress and 2024 Guidance

bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported first quarter results and business highlights for the quarter ended March 31, 2024, including recent commercial and operational progress.

“bluebird has built a solid commercial gene therapy foundation, with an unparalleled network of qualified treatment centers (QTCs), proven access and reimbursement for patients, and demonstrated demand from both patients and providers,” said Andrew Obenshain, chief executive officer, bluebird bio. “Following the completion of the first LYFGENIA patient start earlier this month, and with the continued momentum behind our ongoing launches, we believe we are poised for accelerated growth through the remainder of 2024.”

COMMERCIAL LAUNCH UPDATES

Continued commercial momentum for LYFGENIA (lovotibeglogene autotemcel), ZYNTEGLO (betibeglogene autotemcel) and SKYSONA (elivaldogene autotemcel)

• First LYFGENIA patient start completed in May 2024.
• 14 patient starts completed for ZYNTEGLO and SKYSONA since the beginning of 2024 (11 ZYNTEGLO, 3 SKYSONA).

Validated access and reimbursement strategy is driving favorable coverage landscape

• Successfully confirmed prior authorization approval for commercial and Medicaid-insured patients for LYFGENIA.
• Multiple outcomes-based agreements in place for LYFGENIA with national commercial payer organizations; published coverage policies are in place for more than 200 million U.S. lives.
• Discussions ongoing with Medicaid agencies representing 80% of Medicaid-insured individuals with sickle cell disease in the U.S.
• Timely access to ZYNTEGLO and SKYSONA has continued, with zero ultimate denials for either therapy across both Medicaid and commercial payers.

Substantial QTC footprint established

• bluebird has activated 64 QTCs for LYFGENIA and ZYNTEGLO (defined as a signed MSA).
• Six centers are also activated to administer SKYSONA for patients with cerebral adrenoleukodystrophy (CALD).

2024 GUIDANCE

• The Company anticipates 85 to 105 patient starts (cell collections) combined across all three of its FDA approved therapies (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024. Consistent with previous quarters, bluebird plans to provide quarterly updates on patient starts for each of its therapies.
• Gross-to-net discounts across all three products are expected to be in the range of 20% to 25% of gross revenue in 2024 and will fluctuate based on product and payer mix, as well as utilization of outcomes-based agreements for LYFGENIA and ZYNTEGLO.
• Based on projected timelines from cell collection to infusion, the Company anticipates recognizing revenue from its first infusion of LYFGENIA in the third quarter of 2024.

FIRST QUARTER FINANCIAL HIGHLIGHTS