Analyst Conference Summary

biotechnology

conference date: May 9, 2024 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: First patient started in Lyfgenia process. But expect it to be a slow launch of Zynteglo and Lyfgenia. Restating financial statements, delaying Q1 detailed results.

Basic data (GAAP):

Revenue was $18.6 million, up sequentially from $7.8 million. Mainly product revenue.

Net Income was negative $ million [delayed].

EPS (Earnings per Share) were negative $. [delayed]

Guidance:

Expects 85 to 105 patient starts across all therapis. Revenue for first Lyfgenia infusion expected to be recognized in Q2 2024.

Conference Highlights:

Andrew Obenshain, CEO, said "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. 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" Expects to reach profitability some time in the next five years. More than half of the QTCs hav informed Bluebird they are actively evaluating patients for therapy initiation. No ultimate insurance denials so far.

Working on accounting restatements. Not expected to impact the cash position or revenue.

The first patient start for Lyfgenia for sickle cell disease was in May 2024. But revenue from the first infusion is not expected until Q3 2024. Bluebird confirmed prior authorization approval for commercial and Medicaid-insured patients for Lyfgenia. Revenue for first Lyfgenia infusion expected to be recognized in Q2 2024.

Zynteglo for beta-thalassemia completed 20 patient starts in 2023 and added 7 in 2024.

Skysona for cerebral adrenoleukodystrophy (CALD) had 6 patient starts in 2023 and 3 additional in 2024.

Bluebird continues to make progress arranging reimbursement for its therapies and centers for their administration. To date 64 centers activated for Lyfgenia and Zynteglo and 6 for Skysona.

Bluebird signed a $175 million loan facility with Hercules Capital on March 18, 2024. Took $75 million at closing. The final $50 million tranche is at Hercules' discretion. With just $125 million Bluebird's cash runway is extended through Q1 2025.

Patients under the age of 12 are in study of lovo-cel, with enrollment completion expected in Q4 2024.

Cash and equivalents ended near $264 million, down sequentially from $275 million.

Financial statements for 2022 and 2023 will be restated on its next 10-K. No impact on its cash position is expected. So no details yet on P&L for Q1 2023, but will file a late 10-Q.

Q&A selective summary:

Medicaid reimbursement? Lyfgenia has multiple patients in the process at QTCs. Medicaid is not rate limiting. We have an outcomes-based agreements. So not a barrier for patients.

Lyfgenia in younger patients? We are enrolling patients age 2 to 12, should complete enrollment this year.

Competition at QTCs? Most will eventually offer both, though we are ahead right now. It will be a patient choice.

About 50 of the 64 centers have received referals for Lyfgenia, should be all of them soon.

New start definition? First unique cell collection completion. Once a patient does that, they are highly likely to go through the full procedure.

No timeline yet for completion of financial restatements.

International market? We are entirely focussed on the U.S. launch. We are monitoring markets outside the U.S., if we went there it would be with a partner.

There is no bottleneck, it just takes time for patients to go through the process, particularly for sickle cell. The insurance also takes time, in particular for the first patient at a QTC.

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