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Mar 31, 2023
Phathom Q1 2023 Earnings Report
Phathom reported first quarter 2023 results, highlighting progress in advancing vonoprazan and preparing for commercial launch.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $37.8 million for Q1 2023, with operating expenses decreasing due to cost control measures. The company is on track to resubmit its Erosive GERD NDA and anticipates a potential commercial launch in Q4 2023. They believe they have sufficient capital to fund operations through the end of 2024.
Phathom remains on track to resubmit its Erosive GERD NDA this quarter, with potential FDA approval and commercial launch anticipated in Q4 2023.
Positive topline results were shared from the Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD, with a regulatory submission expected in the second half of 2023.
Phathom has secured coverage for 60% of commercial lives for its H. pylori infection treatments VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK®.
Cash and cash equivalents were reported at $129.6 million as of March 31, 2023.
Phathom
Phathom
Forward Guidance
Phathom anticipates potential approval of its Erosive GERD NDA and subsequent launch in Q4 2023, as well as continued progress in its Non-Erosive GERD program. They expect to have sufficient capital to fund operations through the end of 2024.
Positive Outlook
- On track to resubmit Erosive GERD NDA this quarter.
- Potential FDA approval and commercial launch in Q4 2023.
- Positive topline results from Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD.
- Regulatory submission expected in the second half of 2023 for Non-Erosive GERD.
- Sufficient capital to fund operations through the end of 2024.
Challenges Ahead
- Potential inability to generate required data to meet acceptable nitrosamine impurity intake.
- Risk of the FDA not accepting the Erosive GERD NDA for review.
- Risks associated with product manufacturing or formulation changes.
- The FDA may disagree that existing data is sufficient to approve the erosive esophagitis NDA
- Dependence on third parties for manufacturing, research, and testing.