BridgeBio (BBIO) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Key clinical and scientific updates

• Acoramidis demonstrated superior stabilization of serum TTR, correlating with reduced mortality in ATTR patients, with a significant p-value (<0.001) in the ATTRibute trial.

• Patients switching from tafamidis to acoramidis showed increased serum TTR, supporting higher stabilization and improved outcomes.

• Acoramidis outperformed tafamidis on key biomarkers and showed a 42% higher serum TTR level.

• Clinical data suggest acoramidis provides the best relative risk reduction at 30 months compared to other agents, including Alnylam's vutrisiran.

• Ongoing publication of data, with further long-term results expected at HFSA and AHA.

Commercialization and regulatory milestones

• U.S. commercial launch of acoramidis is planned for late 2024, with the field force fully built and trained.

• Focus on access programs and streamlined prescription processes to differentiate in a high-price category.

• European MAA filed, with anticipated approval in early 2025; Bayer partnership leverages strong cardiovascular infrastructure.

• Ready to launch in Europe, benefiting from clinical trial experience and expert sites.

Market landscape and growth drivers

• ATTR market is expanding, with diagnosed patients rising from 35,000 to nearly 50,000, but many remain untreated due to high drug costs.

• IRA policy changes are expected to reduce patient out-of-pocket costs, potentially increasing drug uptake.

• Market opportunity for ATTR therapies estimated at $10–15 billion, with further growth as diagnosis rates improve.

• Patent protection for tafamidis expected to last until 2035, limiting generic competition in the near term.