Cory Jubinville

Cory Jubinville of LifeSci Capital questioned what near-term levers exist to accelerate Yutrepia's growth and asked about the timing for when the newly signed contracts with major commercial payers would become effective.

Answer

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.'

Cory Jubinville from LifeSci Capital requested more details on the prescriber support team's activities, how they will improve the physician experience, and if a patient bridging program is planned for early access.

Answer

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.

Cory Jubinville of LifeSci Capital sought clarity on launch timelines in light of ongoing litigation, asking how a favorable ruling in the FDA lawsuit might expedite the launch before May 2025. He also questioned if the strategy was to launch in PAH immediately after May 2025 while awaiting the '327 patent decision for the PH-ILD indication.

Answer

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.

Cory Jubinville from LifeSci Capital, LLC asked for context on why Crinetics selected post-glucocorticoid (GC) dose A4 levels as part of its primary endpoint for the CAH studies, and the clinical relevance of assessing efficacy pre-GC versus post-GC.

Answer

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.

Cory Jubinville inquired about Crinetics' European launch strategy for paltusotine, the concentration of patients in centers of excellence in Europe versus the U.S., and any significant differences in regional treatment patterns.

Answer

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.

An analyst on behalf of Cory Jubinville asked about learnings from a competitor's recent CAH launch and how that might inform the future commercial strategy for atumelnant.

Answer

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.

Cory Jubinville inquired about the new nonpeptide drug conjugate (NDC) program, CRN09682, asking for details on its strategic fit, development challenges, and specific advantages over antibody-drug conjugates (ADCs) and radiotherapies.

Answer

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.

Cory Jubinville from LifeSci Capital, LLC asked for details on Xtendi's retreatment rates, the accuracy of third-party data, and the strategic importance of refills versus new patient acquisition.

Answer

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.

Cory Jubinville asked for commentary on total 2025 spending, the potential path to cash flow positivity, and what analytics from the DTC campaign reveal about the most responsive patient profiles.

Answer

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.

Cory Jubinville inquired about the initial physician receptivity to the new MGD data and its expected impact on XDEMVY revenues. He also asked about the capital allocation strategy, balancing the XDEMVY commercial ramp with pipeline development for TP-04 (Ocular Rosacea) and TP-05 (Lyme Disease), and the timeline to cash flow positivity.

Answer

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.

Cory Jubinville from LifeSci Capital inquired about the sales force's strategic focus now that the initial ECP target is nearly met, asking about the proportion of high-volume prescribers. He also asked about physician feedback and company messaging regarding patient retreatment.

Answer

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.