Bridgebio Q4 2023 Earnings Report
Key Takeaways
BridgeBio Pharma reported fourth-quarter financial results, with a focus on executing the launch of acoramidis. The company is also focused on fully enrolling three ongoing Phase 3 clinical trials by the end of 2024.
Filed an NDA for acoramidis for the treatment of ATTR-CM with the US FDA; the NDA was accepted for review with a PDUFA date of November 29, 2024.
Presented additional data from ATTRibute-CM at the American Heart Association Scientific Sessions, demonstrating separation at Month 3 of the placebo and acoramidis time-to-first-event Kaplan-Meier curves for a composite of all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH).
Shared positive results of single-arm Phase 3 study of acoramidis in Japanese ATTR-CM patients, including no mortality reported over the 30 month acoramidis treatment period.
Secured up to $1.25 billion of capital from Blue Owl and CPP investments.
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Bridgebio Revenue by Segment
Forward Guidance
BridgeBio is focused on executing on the launch of acoramidis for patients with ATTR cardiomyopathy, fully enrolling three ongoing Phase 3 clinical trials by the end of 2024, and reading out potentially exciting data from their Phase 1/2 trial in congenital adrenal hyperplasia later this year.
Positive Outlook
- Acoramidis NDA accepted for review with PDUFA date of November 29, 2024.
- Partnership with Kyowa Kirin for infigratinib in Japan, upfront payment of $100 million.
- Advancement of late stage pipeline.
- Diversifying top line revenue.
- Reinvestment into R&D and business development opportunities.
Challenges Ahead
- Uncertainty regarding impacts due to global health emergencies such as COVID-19.
- Potential volatility in share price.
- Increasing rates of inflation and rising interest rates.
- Hostilities in Ukraine and in Israel and the Gaza Strip.
- Delays in regulatory review, manufacturing and supply chain interruptions.