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Sep 30, 2024
Bridgebio Q3 2024 Earnings Report
BridgeBio reported its Q3 2024 financial results and provided a business update.
Key Takeaways
BridgeBio Pharma reported its Q3 2024 financial results, highlighting progress in its late-stage pipeline, including the NDA filing for acoramidis and advancements in other clinical trials. The company ended the quarter with $406 million in cash, cash equivalents, and short-term restricted cash.
Acoramidis NDA was filed with the U.S. FDA with a PDUFA action date of November 29, 2024.
CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, completed screening.
FORTIFY, the Phase 3 clinical trial for LGMD2I/R9, completed enrollment.
The FDA granted Breakthrough Therapy Designation to oral infigratinib for achondroplasia
Bridgebio
Bridgebio
Forward Guidance
BridgeBio is preparing to launch acoramidis in the U.S. upon FDA approval at the end of 2024 and anticipates Phase 3 study readouts in 2025.
Positive Outlook
- Acoramidis NDA was filed with the U.S. FDA with a PDUFA action date of November 29, 2024
- BridgeBio anticipates receiving a $500 million milestone payment upon FDA approval of acoramidis.
- BridgeBio anticipates receiving $105 million in aggregate regulatory milestone payments upon approval of acoramidis in European and Japanese territories.
- The company anticipates completing enrollment of the CALIBRATE study in 2024.
- Enrollment completion for PROPEL 3 study expected in 2024.
Challenges Ahead
- Initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data
- The potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated
- Future regulatory filings, approvals and/or sales
- The FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies
- The continuing success of the Company’s collaborations