Jon Wolleben • Citizens JMP

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Chief Medical Officer Joanne Quan explained that while bile acids play a role, the core issue in PSC is cholestasis, and serum bile acid levels are likely less important than in other indications. COO & President Peter Radovich stated that for the bile acid portfolio, he expects a "gradual steady build" in sales rather than a sharp inflection due to laborious patient finding.

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Pravin Dugel, Executive Chairman, President & CEO, explained the feedback came from investigators who wanted the trial's rescue criteria to reflect their real-world clinical practices, which can be more liberal. Regarding rescue cadence in SOUL-one, he stated that the masked data shows a pattern of rescues consistent with their hypothesis for how the two different agents would perform over time, reinforcing their confidence in the trial's design and potential outcome.

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Dr. Pravin Dugel, President and CEO, reiterated the Investor Day update that 151 patients were in various stages of loading and randomization but did not provide a more recent figure. He confirmed that the screen failure rate for SOL-1 remains lower than initially modeled, which is why the company anticipates that most future SOL-R patients will be recruited externally rather than from SOL-1 screen failures. He emphasized that SOL-1 recruitment is now in an 'exponential phase.'

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President & CCO Charlie Gayer explained that second-half growth is primarily driven by new patient starts, which can slightly lower the overall paid rate temporarily, and lacks the large reauthorization-driven bolus seen in H1. CEO Jon Stonehouse added that Q4 revenue will exclude European sales. Despite these factors, Gayer affirmed confidence in reaching the upper half of the $580M-$600M full-year guidance range after accounting for the divestiture.

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Chief Financial Officer Hunter Smith and Chairman, CEO and President David Meeker clarified that IMCIVREE has high coverage from commercial and Medicaid payers but essentially none from Medicare due to statutory limitations on obesity drugs. They noted that about 20% of scripts transition to free drug and that denials are typically based on payer policy rather than the drug's price. The question about early payer discussions for HO was not directly addressed.

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