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Sep 30, 2023
Phathom Q3 2023 Earnings Report
Phathom Pharmaceuticals reported third quarter 2023 results, highlighted by the FDA approval of VOQUEZNA for Erosive GERD and the submission of an NDA for vonoprazan as a daily treatment for Non-Erosive GERD.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $43.2 million for the third quarter of 2023. The company highlighted the FDA approval of VOQUEZNA for Erosive GERD and the submission of an NDA for vonoprazan as a daily treatment for Non-Erosive GERD.
VOQUEZNA approved by the FDA for Erosive GERD treatment and associated heartburn relief.
Commercial availability of VOQUEZNA for Erosive GERD and H. pylori is expected in December 2023.
NDA submitted to the FDA for vonoprazan as a once-daily treatment for Non-Erosive GERD.
Company believes it is well capitalized to support the blockbuster potential of VOQUEZNA, with an additional $175 million in cash provided under a non-dilutive revenue interest financing agreement.
Phathom
Phathom
Forward Guidance
Phathom believes it will have sufficient capital to fund operations through the end of 2025.
Positive Outlook
- Expected product revenues
- Funds available under its existing term loan with Hercules
- Cash to be paid under our royalty interest financing agreement based on the recent approval of VOQUEZNA for Erosive GERD
- VOQUEZNA FDA approval for Erosive GERD
- NDA submission for vonoprazan as a daily treatment for Non-Erosive GERD
Challenges Ahead
- We may not be able to successfully commercialize VOQUEZNA which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers
- Future data generated from our stability program may be different from the data submitted to the FDA to date and may not demonstrate that our mitigation efforts will continue to maintain the level of the nitrosamine impurity below the acceptable intake (AI) level throughout the shelf life of products containing vonoprazan, which could result in market action or shelf life reduction
- Risks associated with product manufacturing or formulation changes required to be made in connection with achieving the AI
- The inherent risks of clinical development of vonoprazan
- Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing