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Dec 31, 2022
Phathom Q4 2022 Earnings Report
Phathom reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $55.0 million for the fourth quarter ended December 31, 2022, compared to a net loss of $35.8 million for the fourth quarter of 2021. Research and development expenses for the fourth quarter 2022 were $15.9 million, and general and administrative expenses were $30.7 million. Cash and cash equivalents were $155.4 million as of December 31, 2022.
Phathom delivered positive topline results for its third Phase 3 trial, PHALCON-NERD-301, evaluating vonoprazan for non-erosive GERD.
Phathom reported positive topline results from a Phase 2 proof-of-concept trial for vonoprazan dosed as needed for non-erosive GERD.
The FDA approved VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for the treatment of Helicobacter pylori (H. pylori) infection in adults on May 3, 2022.
Phathom secured up to $300 million in non-dilutive capital under the terms of its revenue interest financing agreement.
Phathom
Phathom
Forward Guidance
Phathom anticipates generating stability data to support the proposed shelf life of vonoprazan and approval of its erosive esophagitis NDA. They also anticipate product launches in H. pylori and erosive esophagitis and believe they will have sufficient capital to fund operations through 2024.
Positive Outlook
- Expectations of generating stability data necessary to support the proposed shelf life of vonoprazan.
- Potential approval of its erosive esophagitis NDA and post approval supplements for its H. pylori NDAs.
- Anticipated product launches in H. pylori and erosive esophagitis.
- Potential of vonoprazan to provide patients with a rapid relief agent to treat non-erosive GERD.
- Belief that Phathom will have sufficient capital to fund operations through 2024.
Challenges Ahead
- Phathom may be unable to generate the required data to meet the acceptable intake of its nitrosamine impurity.
- The FDA may disagree that the existing safety and efficacy data, together with additional data, is sufficient to approve the erosive esophagitis NDA or supplements to the H. pylori NDAs.
- 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.
- Phathom’s ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions.
- Phathom’s ability to comply with its license agreement with Takeda.