Loading...
•
Sep 30, 2021
Phathom Q3 2021 Earnings Report
Phathom reported financial results and provided clinical, regulatory, and business updates.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $36.7 million for the third quarter of 2021. The FDA accepted NDAs for two vonoprazan-based treatment regimens for H. pylori infection, and positive Phase 3 trial results for vonoprazan in erosive esophagitis were reported.
Two New Drug Applications (NDAs) for vonoprazan-based treatment regimens for H. pylori infection were accepted for filing by FDA with six-month Priority Review granted; PDUFA target action date of May 3, 2022.
U.S. launch for both vonoprazan-based treatment regimens for H. pylori anticipated in the second half of 2022, if approved.
Positive Phase 3 trial results for vonoprazan in erosive esophagitis (EE) reported in October 2021; NDA submission targeted for the first quarter of 2022.
Phathom secured an up to $200 million term loan facility from Hercules Capital.
Phathom
Phathom
Forward Guidance
Statements in the press release regarding matters that are not historical facts are forward-looking statements based on current beliefs and expectations.
Positive Outlook
- Expected availability of topline results from the PHALCON-NERD on demand clinical trial
- Expected submission of an NDA for the healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn
- Expected approval of NDAs for vonoprazan-based treatments for the treatment of H. pylori infection
- Company’s ability to access additional capital under the Loan Agreement
- The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved.
Challenges Ahead
- Reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data
- Company may experience delays submitting an NDA including in the event that the FDA does not agree with the Company’s interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA
- Phathom’s ability to access additional capital under the Loan Agreement is subject to certain conditions including verification by the lender that the clinical milestone has been met
- Company’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