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Dec 31, 2020
Bridgebio Q4 2020 Earnings Report
BridgeBio reported financial results for Q4 and full year 2020 and provided a business update.
Key Takeaways
BridgeBio Pharma reported its Q4 and full year 2020 financial results, highlighting the completion of the Eidos Therapeutics acquisition and progress in clinical trials. The company ended the quarter with $607.1 million in cash, cash equivalents, and marketable securities.
Completed acquisition of Eidos Therapeutics, allowing BridgeBio to deploy its clinical and commercial infrastructure for acoramidis.
The FDA accepted the NDA for infigratinib for cholangiocarcinoma under Priority Review and the RTOR pilot program.
Initiated two new clinical trials and progressed 17 ongoing clinical trials.
Ended the quarter with $607.1 million in cash, cash equivalents, and marketable securities.
Bridgebio
Bridgebio
Forward Guidance
BridgeBio anticipates several major milestones in 2021 or early 2022 for its four core value drivers, with topline results expected for Acoramidis and initial data for Encaleret, low-dose Infigratinib, and BBP-631.
Positive Outlook
- Topline results from Part A of the ATTRibute-CM trial for Acoramidis are expected in late 2021 or early 2022.
- Early results from an ongoing Phase 2 proof-of-concept study for Encaleret will be shared at the Endocrine Society’s 2021 Annual Meeting on March 20th.
- Initial data from the ongoing Phase 2 dose ranging study for low-dose Infigratinib are expected in the second half of 2021.
- Initiation of a first-in-human Phase 1/2 study for BBP-631 is expected in the second half of 2021, with initial data anticipated in late 2021 or early 2022.
- The company expects current cash, cash equivalents and marketable securities to support its planned operations into 2023.
Challenges Ahead
- The unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or our operations or operating expenses.
- Uncertainty of the expected financial performance of each of us and Eidos following completion of the merger, including the possibility that the expected synergies and value creation from the merger will not be realized or will not be realized within the expected time period.
- Despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted.
- Potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy.
- Success of clinical trials, regulatory filings, approvals and/or sales