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Sep 30, 2023
Bridgebio Q3 2023 Earnings Report
Reported financial results and business update for the third quarter of 2023.
Key Takeaways
BridgeBio Pharma reported third quarter 2023 financial results, highlighting progress in its late-stage pipeline, including the upcoming launch of its ATTR-CM asset, acoramidis. The company ended the quarter with $522 million in cash, cash equivalents, and short-term restricted cash after raising $316 million via ATM facility and a private placement equity financing.
Presented positive results from the ATTRibute-CM Phase 3 study of acoramidis at the European Society of Cardiology (ESC) Congress.
Expects to file an NDA for acoramidis with the U.S. Food and Drug Administration (FDA) by the end of 2023.
Reached alignment with the FDA and the European Medicines Agency (EMA) on a single pivotal one-year, randomized, placebo-controlled Phase 3 clinical trial for infigratinib in children with achondroplasia.
Signed a multi-year partnership with National Resilience, Inc. (Resilience) to advance BBP-631, BBP-812 and future gene therapy treatments.
Bridgebio
Bridgebio
Forward Guidance
BridgeBio is focused on advancing its pipeline of genetic disease and cancer treatments, with key milestones expected in the near term. The company anticipates filing an NDA for acoramidis by the end of 2023 and initiating a Phase 3 trial for infigratinib. Strategic partnerships and financial activities aim to support these developments and drive the company towards profitability.
Positive Outlook
- NDA filing for acoramidis expected by the end of 2023.
- Phase 3 trial initiation for infigratinib expected by the end of 2023.
- Advancement of three lead KRAS programs with IND application planned for BBO-8520 in 2023.
- Partnership with Resilience expected to reduce gene therapy manufacturing costs.
- Potential capitalization to profitability through strategic financing activities.
Challenges Ahead
- Clinical trials may not produce desired results.
- Regulatory agencies may not agree with the company's approval strategies.
- The company's ability to obtain additional funding is uncertain.
- Global health emergencies and macroeconomic events could have adverse effects.
- There is potential volatility in the company's share price.