Cory Jubinville • LifeSci Capital

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CCO Scott Moomaw highlighted significant opportunities in expanding both the breadth of prescribers and the depth of prescribing within existing accounts. CEO Roger Jeffs added five specific levers, including leveraging payer coverage, the switch opportunity, and dosing flexibility. Regarding payer contracts, Dr. Jeffs reiterated that the payer landscape is expected to improve 'in the coming quarters.'

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Chief Commercial Officer Scott Moomaw addressed the questions, highlighting his team's decade-plus experience with treprostinil and specialty pharmacies. He stated that while specific details will be shared post-approval, the company has built a comprehensive support program designed to be best-in-class and ensure a seamless experience for physicians and patients starting the therapy.

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General Counsel Russell Schundler stated that the exact impact of a favorable FDA lawsuit ruling depends on the decision's timing and specifics. He confirmed the PAH indication is now unencumbered by the initial patents. Regarding a potential 'at-risk' launch for PH-ILD, he reiterated that the decision will be made upon approval, but the company would not hesitate to launch if it believes no valid patents are infringed, citing substantial prior art against the '327 patent.

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CEO R. Scott Struthers emphasized the goal is to get patients to normal A4 levels, not just a percentage of a high baseline. Chief Endocrinologist Alan Krasner explained that measuring post-GC A4 is the optimal time to assess the trough level of androgen exposure, follows regulatory precedent set by Crinesity, and helps facilitate variability assumptions for a well-powered Phase III trial.

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Isabel Kalofonos, Chief Commercial Officer, stated that the initial launch focus is on Germany, where patient concentration in centers of excellence is even higher than in the U.S. (around 70%). She noted the company is developing its market access strategy and plans a gradual, thoughtful geographic expansion, with Brazil also being considered due to high unmet need.

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CEO R. Struthers responded that it is too early to draw conclusions from the competitor's launch. He acknowledged the competitor as a good commercial company and stated that Crinetics is watching their progress closely to learn from their experience.

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CEO R. Struthers explained that the NDC platform leverages Crinetics' expertise in small molecule design for GPCRs, offering advantages like simpler chemical synthesis, better target tuning for internalization, and faster clearance compared to antibodies. He noted the program is synergistic with their work in neuroendocrine tumors (NETs) and that more preclinical data would be shared at the upcoming NANETS meeting.

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CCO Aziz Mottiwala explained that third-party data understates refills and that Tarsus's internal data shows retreatment rates have risen to just over 10%, trending toward their 20% annualized steady-state goal. He stressed that while refills are an important tailwind, the primary focus remains on penetrating the large, untapped market of new patients.

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CFO Jeff Farrow confirmed that operating expenses will continue to grow due to DTC and pipeline investments and stated the company is not providing guidance on reaching cash flow positivity at this time. CCO Aziz Mottiwala explained that DTC analytics helped tailor their campaign to two key demographics: commercially insured patients in their mid-40s and Medicare patients aged 60+ who are often preparing for cataract surgery. CEO Bobak Azamian added that anecdotally, patients are now recognizing the XDEMVY brand name when speaking with their doctors.

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Chief Commercial Officer Aziz Mottiwala stated that physicians are receptive to the MGD data as it provides objective benefits and addresses key patient outcomes like fluctuating vision, though it will take time to educate the market. Chief Financial Officer Jeff Farrow emphasized that capital allocation prioritizes the XDEMVY launch, with the TP-04 Phase II study representing a manageable $7-10M cost. He reiterated that the Lyme disease program is a long-term opportunity likely suited for a larger partner.

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Chief Commercial Officer Aziz Mottiwala confirmed the focus is shifting from expanding the prescriber base to increasing the depth and frequency of prescribing among the existing 13,000 ECPs. He noted it's too early to share metrics on "prolific" writers but that is the goal. Regarding retreatment, he explained they educate doctors on the disease's chronic nature and expect a spectrum of physician behaviors, from proactive retreatment at 6 months to reactive treatment upon symptom recurrence.

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