Jason Dorr

Jason Dorr, on behalf of Leland Gershell from Oppenheimer, asked how the SUMMIT open-label expansion study for AGAMREE might influence future forecasts and the 2026 guidance, and about the strategy for exploring additional indications to support AGAMREE's growth.

Answer

Rich Daly, President and CEO, stated that the SUMMIT study is actively enrolling patients to gather robust long-term data on glucocorticoid side effects. Will, a Company Representative, highlighted encouraging data from Santhera's GUARDIAN trial, showing normal growth and decreased adverse events in AGAMREE-treated patients. However, Mr. Daly clarified that since these endpoints are not yet in AGAMREE's label, they do not currently impact the 2026 forecast or guidance, but the data is highly encouraging for future potential. The company is also actively evaluating additional target indications for lifecycle management.

Jason Dorr asked about the anticipated impact of the SUMMIT open-label expansion study on AGAMREE's future forecast and its inclusion in the 2026 guidance. He also inquired about the company's strategy for pursuing additional indications to support AGAMREE's growth.

Answer

Rich Daly, President and CEO, and Will, Company Representative, confirmed that the SUMMIT study is actively enrolling patients to gather robust long-term data on glucocorticoid side effects. While Santhera's related data is encouraging, it currently has no impact on AGAMREE's 2026 guidance or promotional efforts as the endpoints are not in the label. Will also mentioned that a Phase 1 study is evaluating dose equivalence and immunosuppressive activity, which will inform active lifecycle management evaluations for potential new indications.

Jason Dorr from Oppenheimer & Co. Inc. asked about the key topics to be addressed in the upcoming end-of-Phase 2 FDA meeting for Haduvio in IPF cough and requested details on the planned trial for non-IPF ILD chronic cough.

Answer

Chief Development Officer James Cassella outlined that the FDA meeting will focus on aligning on the Phase 3 protocol, dose selection, and the required safety database size. For non-IPF ILD, he noted the trial will include patients with various underlying fibrotic diseases. CEO Jennifer Good added that the company's strategy for the non-IPF ILD trial has evolved to a parallel arm design to potentially accelerate the program.

Jason Dorr from Oppenheimer & Co. Inc. inquired about the evolution of the Gvoke treatment landscape over the next few years, especially concerning competitors, and requested more detail on the revenue outlook for the Gvoke VialDx collaboration with American Regent.

Answer

CEO John Shannon addressed the Gvoke landscape by highlighting the vast, underserved market of roughly 14 million at-risk diabetes patients who lack a ready-to-use glucagon. He sees the long-term opportunity as a collective effort with competitors to increase guideline adherence. Regarding Gvoke VialDx, he stated that more detailed guidance will be provided after the partner's launch later in the year, with minimal revenue impact expected in 2025.

Jason Dorr asked if management could provide a preview of the pivotal study design for the XP-8121 program ahead of the company's scheduled Investor Day.

Answer

CEO John Shannon declined to share early details, emphasizing the company's plan to present a complete and comprehensive overview of the product's opportunity, development plan, and study design all at once during the Analyst and Investor Day on June 3 to ensure the message is communicated clearly.