Eddie Hickman

Eddie Hickman inquired about the detailed expectations for Tarsus' full-year guidance beyond Q1, specifically concerning bottle dispense rates, refill dynamics, and the anticipated impact of seasonal disruptions like conferences, weather, and holidays on future growth as the launch matures.

Answer

Jeffrey Farrow, Chief Financial Officer and Chief Strategy Officer, outlined the expected seasonal revenue cadence, including Q1 flatness due to deductible resets, a Q2 bump, tempered Q3, and robust Q4, while declining to provide specific bottle or gross-to-net guidance. Aziz Mottiwala, Chief Commercial Officer, added that as the launch progresses, the brand becomes more susceptible to typical seasonality, but strong fundamentals like deepening prescriber utilization, growing consumer awareness, and increasing refills provide confidence in continued growth, despite the NRx-driven susceptibility to disruptions.

Eddie Hickman asked for more detail on Tarsus' expectations for XDEMVY sales beyond Q1 2026, specifically regarding bottle dispense rates, refill dynamics, and the expected impact of seasonal disruptions on future growth.

Answer

Jeffrey Farrow, Chief Financial Officer and Chief Strategy Officer, explained that the full-year guidance incorporates typical seasonality, with Q1 flat to slightly down, Q2 a nice bump, Q3 tempered, and Q4 robust growth, with gross-to-nets and bottles dispensed baked into the guidance. Aziz Mottiwala, Chief Commercial Officer, added that as the launch progresses, the brand becomes more susceptible to typical seasonality, but strong prescriber utilization, growing consumer awareness (1 in 4 patients aware), and increasing refills reinforce confidence in long-term growth, despite continued susceptibility to NRx-driven disruptions.

Eddie Hickman of Guggenheim Partners inquired about the source of new Xtendi prescribers, the durability of the DTC campaign, and the long-term outlook for gross-to-net discounts.

Answer

Chief Commercial Officer Aziz Mottiwala confirmed the 5,000 new prescribers are from their target list and that the core prescriber base is deepening its usage without erosion. He noted the DTC campaign will continue for the foreseeable future at a steady expense level. Chief Financial Officer Jeff Farrow advised that gross-to-net is expected to stabilize in the low 40s, which should be used for modeling purposes beyond 2025.

Eddie Hickman asked about factors preventing long-range guidance, the number of prescribers reached beyond the 15,000 target, and whether channel stocking levels are expected to change.

Answer

CFO Jeff Farrow cited the need to assess the full impact of the expanded DTC campaign and monitor macro events as the primary reasons for pausing on long-range guidance. CCO Aziz Mottiwala clarified that while more than 15,000 doctors have prescribed XDEMVY, the strategic focus remains on deepening prescribing within that core group. Farrow also stated they do not anticipate channel inventory changing from the current level of approximately 2.5 weeks.

Eddie Hickman asked why Tarsus is not providing full-year guidance despite expressing confidence in Q1 dynamics. He also inquired about the predictive accuracy of DTC website engagement metrics for new patient prescriptions.

Answer

Chief Financial Officer Jeff Farrow stated that providing full-year guidance is premature due to uncertainties around the impact of the DTC campaign, particularly its expansion into network TV. An executive added that while website metrics show good directional correlation, it will take more time to quantify the conversion rate at scale, as the patient journey from ad exposure to prescription can take several quarters.

Eddie Hickman of Guggenheim Securities inquired about the resource requirements for the MGD market expansion, the expected timing and payer reimbursement for patient retreatments, and the recent evolution of the IQVIA data capture rate.

Answer

Aziz Mottiwala, Chief Commercial Officer, stated that the current sales force and DTC campaign are sufficient for the MGD opportunity, as it involves screening existing MGD patients for Demodex blepharitis. He noted that retreatment rates are currently in the single digits but are expected to reach ~20% over time. Chief Financial Officer Jeff Farrow commented that IQVIA data is imperfect and has recently shown a modest increase over actuals, but its future accuracy is uncertain.

Eddie Hickman of Guggenheim Securities asked about the expected cadence for penetrating the remaining diagnosed NPC patient population and the logistics of initiating Myclifa and miglustat therapy simultaneously.

Answer

Chief Commercial Officer Joshua Schafer responded that while it is too early in the launch to predict the future cadence of enrollments, the 26% quarter-over-quarter net sales growth demonstrates strong performance in converting and retaining patients. He also confirmed that patients can, and do, start both Myclifa and miglustat at the same time without issue.

Eddie Hickman of Guggenheim Securities requested qualitative metrics on MIPLYFFA's performance, such as refill rates, patient retention, and average net price, to help model its trajectory. He also asked if the current pace of new patient starts would continue and about the challenges in penetrating the non-EAP patient population.

Answer

Chief Commercial Officer Joshua Schafer indicated that the vast majority of patients are receiving refills and staying on the drug, reflecting the durability seen in the EAP. He also noted the average net price is trending similarly to the EAP experience. President and CEO Neil McFarlane declined to give forward-looking guidance on patient start cadence but expressed confidence in continued performance driven by the product's strong clinical data. He also confirmed that prior guidance on average pricing remains valid.

Eddie Hickman asked for guidance on how to model MIPLYFFA discontinuation rates and what the long-term retention expectations are for the initial bolus of patients.

Answer

CCO Joshua Schafer stated it was too early in the launch to provide a specific discontinuation rate. However, CEO Neil McFarlane provided context by pointing to the high long-term retention observed in the company's Expanded Access Program and open-label extension studies, where some patients have remained on therapy for 5-7 years. He suggested this longevity, driven by the product's profile, could be indicative of future commercial trends.

Eddie Hickman asked about the reimbursement process for off-label miglustat use in NPC compared to the newly approved MIPLYFFA, whether miglustat use could be a leading indicator for MIPLYFFA uptake, and why about 20% of patients are not on miglustat.

Answer

President and CEO Neil McFarlane explained that he could not comment on the specifics of the miglustat reimbursement process but noted that patients on miglustat are successfully getting MIPLYFFA approved. He stated that tracking total miglustat use is not a reliable leading indicator for NPC due to its generic status and primary indication for Gaucher's disease. He clarified that the primary reasons some patients are not on miglustat are tolerability issues and payer access challenges.

Eddie Hickman of Guggenheim Partners, on for Yatin Suneja, inquired about the real-world discontinuation rate for Auvelity and the main hurdles to achieving broader commercial coverage beyond the current ~63%.

Answer

An executive, likely CCO Ari Maizel, stated that observed persistency for Auvelity has been very positive, even outpacing SSRIs/SNRIs in an internal analysis. The primary hurdles to broader coverage are finalizing rebate agreements and utilization management criteria with remaining plans, with negotiations ongoing.

Inquired about the number of active clinical trial sites for NORSE EIGHT and their activation cadence, current thinking on pricing, the study's 3-month duration, and post-study treatment plans for patients.

Answer

Over 60 sites are active, reaching full strength in April/May, with 30% of patients already enrolled. On pricing, the company sees a two-segment market and aims to be the approved, quality option in the lower-cost bevacizumab segment. The study is confirmed as a 90-day trial with a day-60 primary endpoint. Post-study treatment is at the discretion of doctors and payers, but study participation is seen as a good way to engage future prescribers.

Eddie Hickman inquired about the number of active clinical trial sites for NORSE EIGHT, the cadence of site activation, and the company's latest pricing discussions with payers, considering recent market changes. He also asked about the implications of the study's 3-month duration for retaining participating doctors for a future launch.

Answer

Executive C. Trenary reported that over 60 sites are actively enrolling patients, having reached full strength in April and May, leading to 30% enrollment. On pricing, he noted that new high-priced brand launches are increasing the market's average selling price (ASP), reinforcing the two-segment market where ONS-5010 will compete in the lower-cost bevacizumab segment. He added that the 90-day study design allows doctors to see the positive non-inferiority results firsthand, which is the best strategy for recruiting them for the commercial launch.