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Jun 30, 2020
Bridgebio Q2 2020 Earnings Report
BridgeBio reported financial results for the second quarter ending June 30, 2020, and provided a business update. The company initiated four clinical trials, progressed 11 ongoing clinical trials, and submitted three INDs to the FDA since the beginning of 2020. A strategic collaboration with LianBio expanded BridgeBio’s global reach into China.
Key Takeaways
BridgeBio Pharma reported its Q2 2020 financial results, highlighting the initiation of four clinical trials, progression of 11 ongoing trials, and submission of three INDs to the FDA. The company ended the quarter with $840.9 million in cash, cash equivalents, and marketable securities and expanded its global reach through a collaboration with LianBio.
Initiated four clinical trials and progressed 11 ongoing clinical trials since the beginning of 2020.
Submitted three Investigational New Drug (IND) applications to the FDA.
Entered into a strategic collaboration with LianBio to expand global reach into China.
Ended the quarter with $840.9 million in cash, cash equivalents, and marketable securities.
Bridgebio
Bridgebio
Forward Guidance
BridgeBio anticipates major milestones over the next 18-24 months for its four core value drivers, including acoramidis for ATTR, low-dose infigratinib for achondroplasia, encaleret for ADH1, and BBP-631 for CAH. The company expects to complete enrollment in the Phase 3 ATTRibute-CM study in the first half of 2021, report initial data from the Phase 2 dose ranging study of infigratinib by YE2021, initiate the Phase 2 study of encaleret in 2020, and initiate a Phase 1/2 study of BBP-631 and report initial data in 2021.
Positive Outlook
- Remain on track to complete enrollment in the Phase 3 ATTRibute-CM study in ATTR cardiomyopathy in the first half of 2021, with topline data expected in the first half of 2022 for Acoramidis.
- Remain on track to report initial data from the ongoing Phase 2 dose ranging study by YE2021 for low-dose infigratinib for achondroplasia.
- Remain on track to initiate the planned Phase 2 study in 2020, with potential proof-of-concept data available in 2021 for encaleret for Autosomal Dominant Hypocalcemia Type 1 (ADH1).
- Remain on track to initiate a first in human Phase 1/2 study and report initial data in 2021 for BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH).
- Strategic collaboration with LianBio will initially focus on targeted oncology.
Challenges Ahead
- The longer-term impact of COVID-19 on operating expenses is currently unknown.
- Success of clinical trials is subject to risks, uncertainties and assumptions.
- Regulatory filings, approvals and/or sales, including those of infigratinib and BBP-398 in China and other major Asian markets, are subject to risks.
- 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.
- Operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.