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CEO Roger Jeffs stated that Yutrepia's uptake has been accelerating sequentially each week, not a one-time bolus. He noted the company is not yet disclosing the specific PAH vs. PH-ILD patient split. Both Dr. Jeffs and CMO Dr. Rajeev Sager explained that median data is used for the ASCENT study to minimize the impact of outliers in the open-label trial, providing a more reflective result, and added that mean and median values are close.

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General Counsel Russell Schundler clarified that there are no active legal proceedings seeking to enjoin YUTREPIA's approval or launch. He explained that while a 'without prejudice' dismissal allows United Therapeutics to refile, they would face significant standing issues and still need to prove the merits of their case, making a repeat of the same argument unlikely to succeed.

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General Counsel Russell Schundler explained that the timing for a judicial ruling is unpredictable and outlined three primary outcomes: upholding the FDA's decision, overruling it, or remanding it for further consideration. Chief Medical Officer Dr. Rajeev Saggar stated that if the submitted ASCENT trial data is accepted by a medical congress, it would be presented in the first half of 2025. CEO Dr. Roger Jeffs added that this data will showcase YUTREPIA's differentiated value regarding dose, clinical outcomes, and treatment durability.

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CEO Dr. Roger Jeffs explained that higher, titratable doses of prostacyclins are crucial for managing progressive diseases, and YUTREPIA's formulation allows for this with fewer systemic side effects. Chief Medical Officer Dr. Rajeev Saggar added that data from the INCREASE study showed better outcomes at higher doses. Regarding the ASCENT trial, Dr. Saggar detailed that the study is assessing safety, tolerability, and durability, with a focus on upcoming data presentations on clinical efficacy. Dr. Jeffs projected the trial would complete by year-end 2024, with publication in 2025.

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President and CEO Mike Raab stated that any contribution from Xphozah transitional scripts was "inconsequential." CCO Eric Foster added that while Ibsrela is positioned post-secretagogue, its first-line indication is appropriate, and use in that setting occurs as physicians gain confidence, with the company focused on ensuring patient access regardless of line.

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CEO Michael Raab acknowledged this disconnect is a common phenomenon that represents a significant opportunity. CCO Eric Foster added that the main challenge is not in identifying patients dissatisfied with secretagogues, but in creating urgency for physicians to act and break decade-old prescribing habits by making IBSRELA the first choice for these patients.

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President and CEO Michael Raab confirmed the Q4 payer mix was approximately 60% Medicare and 40% non-Medicare. Both Raab and CCO Eric Foster explained that the current strategy relies on a high-approval-rate prior authorization process rather than payer discounts, and that access for non-Medicare patients remains strong.

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Richard Lowenthal, Co-Founder, President and CEO, clarified that neffy is positioned as a supplemental, acute treatment for CSU, not a replacement for chronic therapies like XOLAIR. He emphasized that neffy would address the significant unmet need for immediate relief from breakthrough flares that occur even while patients are on chronic medication, offering a unique advantage over waiting for symptoms to subside or seeking emergency care.

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Chief Commercial Officer Eric Cox outlined the partnership strategy, stating that for glepaglutide, they seek a strong commercialization partner, potentially as part of a broader rare disease franchise deal. Regarding the short bowel syndrome market, he sees opportunities across multiple segments: converting existing Gattex patients seeking better control or convenience, as well as capturing the significant population of currently untreated patients.

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Chief Commercial Officer Eric Cox responded. He explained that for glepaglutide, the ideal deal involves a strong commercialization partner, possibly as part of a broader rare disease franchise. Regarding the short bowel syndrome market, Mr. Cox stated that Zealand sees opportunities across all segments, including converting existing Gattex patients (for both better control and convenience) and capturing the significant untreated patient population.

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President and CEO Stephen Mahoney stated definitively that the company's FcRn program is focused on opportunities outside of TED. He affirmed the belief that IGF-1R is the key and most direct target for treating moderate to severe TED.

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Interim CEO Neal Walker explained that Aclaris holds method-of-use IP from Columbia University for using JAK inhibitors to treat alopecia. He highlighted the two existing royalty-bearing deals: one with Eli Lilly and Company for baricitinib and another with Sun Pharmaceutical Industries for deuterated ruxolitinib. Walker emphasized that Aclaris considers the IP estate highly valuable and will continue to seek ways to enhance its value.

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