Analyst Conference Summary

biotechnology

conference date: March 26, 2023 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview: Expect it to be a slow launch of Zynteglo and Lyfgenia.

Basic data (GAAP):

Revenue was $7.8 million. Mainly product revenue.

Net Income was not stated.

EPS (Earnings per Share) were not stated.

Guidance:

Cash runway to Q1 2026. Patient starts in 2024 between 85 and 105.

Conference Highlights:

Andrew Obenshain, CEO, said "In 2023, bluebird established a validated, commercial gene therapy strategy that brought Zynteglo and Skysona to individuals living with beta-thalassemia and cerebral adrenoleukodystrophy. Building on that foundation, today we are positioned for robust commercial uptake of Lyfgenia for sickle cell disease, with a substantial QTC network in place, favorable Medicaid coverage being established, and demonstrated strong patient demand. Our recent agreement with Hercules Capital meaningfully extends our cash runway, and further enables us to capitalize on our commercial head start and bring our transformative gene therapies to patients and their families. In 2024, we anticipate between 85 to 105 patient starts across our three FDA approved therapies, laying the foundation for strong revenue growth." Expects to reach profitability some time in the next five years.

The first patient start for Lyfgenia for sickle cell disease is expected in Q2 2024. But revenue from the first infusion is not expected until Q3 2024.

Zynteglo for beta-thalassemia completed 20 patient starts in 2023 and added 7 in Q1 2024.

Skysona for cerebral adrenoleukodystrophy (CALD) had 6 patient starts in 2023 and 2 additional in Q1 2024.

Bluebird continues to make progress arranging reimbursement for its therapies and centers for their administration.

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 $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 Q4 2023, but will file a late 10-Q.

Q&A selective summary:

Q4 revenue stepdown? Strong demand built over the year 2023. Some Zynteglo patients elected to start at the end of 2023, but did not get infusions until 2024.

Ramp in 2024 for starts? We expect the majority of starts and revenue to be in the second half of 2024.

Lyfgenia patients? We expect half or more of volume to come from Lyfgenia, trend in H2. We have a number of patients who have enrolled in the process this year, but it takes about 2 months to get ready for therapy. It takes 1 to 2 quarters for the full process (collection to infusion).

Manufacturing capacity? Supply chains are separate for each therapy. We have plenty of capacity to meet launch expectations, plus plans to expand when necessary.

The drug product expires after about a year, so that would mean they had not completeed the therapy.

We have heard of long wait lists at QTCs who want to get treated, but we believe they will mostly try it a few times before lining people up. We do not expect a bolus.

We are currently focussed on the U.S. If we went abroad it would be with a partner.

Gross margin should improve over time to our 70% target.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: