Phathom Q4 2020 Earnings Report
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $53.7 million for the fourth quarter of 2020, driven by operating expenses, including research and development, and general and administrative costs. The company highlighted the completion of patient enrollment in Phase 3 trials for vonoprazan and the planned expansion of its development program.
Completed patient enrollment in pivotal Phase 3 trial for vonoprazan in erosive esophagitis (PHALCON-EE).
Completed patient enrollment in pivotal Phase 3 trial for vonoprazan in H. pylori infection (PHALCON-HP).
Announced the planned expansion of vonoprazan development program into NERD.
Completed a successful public offering of common stock with net proceeds of approximately $89 million.
Phathom
Phathom
Forward Guidance
Phathom anticipates topline results from PHALCON-HP in Q2 2021, initiation of Phase 2 NERD trial in Q2 2021, NDA submission for H. pylori in the second half of 2021, topline results for PHALCON-EE in the second half of 2021 and enrollment completion of Phase 2 NERD trial in the second half of 2021.
Positive Outlook
- Topline results for PHALCON-HP in the second quarter of 2021.
- Initiation of Phase 2 non-erosive reflux disease (NERD) trial in the second quarter of 2021.
- NDA submission for H. pylori in the second half of 2021.
- Topline results for PHALCON-EE in the second half of 2021.
- Enrollment completion of Phase 2 NERD trial in the second half of 2021.
Challenges Ahead
- Potential additional delays in the commencement, enrollment and completion of clinical trials due to the COVID-19 pandemic and other factors outside of Phathom’s control
- Patients already enrolled in PHALCON-EE and PHALCON-HP may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trials all together, which may adversely impact its trial results and development plans
- Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing
- Unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims
- Phathom’s ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain