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Jun 30, 2022
Phathom Q2 2022 Earnings Report
Phathom reported financial results for the second quarter of 2022 and provided recent business updates.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $50.9 million for the second quarter of 2022. The company is preparing for a combined full commercial launch of both H. pylori and EE in the first quarter of 2023.
VOQUEZNA DUAL and TRIPLE PAK approved by FDA for treatment of H. pylori infection on May 3, 2022.
Erosive Esophagitis (EE) New Drug Application (NDA) accepted by U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) action date of January 11, 2023; if approved, targeting US launch in Q1 2023.
Initial testing for nitrosamines revealed trace levels in vonoprazan commercial drug product; working with FDA to make VOQUEZNA DUAL and TRIPLE PAK available to patients as soon as possible.
Topline data for primary endpoint in Phase 3 non-erosive reflux disease (NERD) daily dosing trial expected in Q1 2023
Phathom
Phathom
Forward Guidance
Phathom is planning for a combined full commercial launch of both H. pylori and EE in the first quarter of 2023.
Positive Outlook
- Potential approval of EE NDA
- Plans to launch vonoprazan for H. pylori and EE indications
- Expected timing of topline data for the NERD Phase 3 trial
- Working with FDA to resolve nitrosamine impurity issue
- Sufficient capital to fund operations through 2024
Challenges Ahead
- FDA may disagree that the existing safety and efficacy data is sufficient to approve the EE NDA
- Potential for the FDA to delay the PDUFA target action date related to the EE NDA
- Inherent risks of clinical development of vonoprazan
- Dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing
- Unexpected adverse side effects or inadequate efficacy of vonoprazan