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Jun 30, 2023
Phathom Q2 2023 Earnings Report
Phathom reported second quarter 2023 results, highlighted by regulatory submissions, successful capital raise resulting in $141.4 million in net proceeds, and salesforce recruiting commencement.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $41.0 million for the second quarter of 2023. The company made significant progress on regulatory submissions for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, completed a public offering resulting in $141.4 million in net proceeds, and is preparing for commercial launches in Q4 2023.
Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a PDUFA goal date of October 30, 2023.
U.S. commercial launch for H. pylori and Erosive GERD planned for Q4 2023.
Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD was successfully completed, with regulatory submission on track for year-end.
Net proceeds of $141.4 million were recorded from a completed public offering of common stock.
Phathom
Phathom
Forward Guidance
Phathom anticipates potential approval of its Erosive GERD NDA and prior approval supplements for its H. pylori convenience pack NDAs, and product launches in H. pylori and Erosive GERD. A regulatory submission for Non-Erosive GERD is expected, and the company believes it has sufficient capital to fund operations through the end of 2025.
Positive Outlook
- Potential approval of Erosive GERD NDA.
- Potential approval of H. pylori convenience pack NDAs.
- Anticipated product launches in H. pylori and Erosive GERD.
- Potential regulatory submission for Non-Erosive GERD.
- Sufficient capital to fund operations through the end of 2025.
Challenges Ahead
- Inability to generate required data to meet acceptable nitrosamine impurity intake.
- Inability to reduce impurity to an acceptable level throughout the shelf life of the product.
- FDA may not accept H. pylori convenience pack supplements for review.
- Risks associated with product manufacturing or formulation changes.
- FDA may disagree that existing data is sufficient for approval.