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    Uy Ear • Mizuho Securities

    Uy Ear's questions to Arcutis Biotherapeutics Inc (ARQT) leadership

    Uy Ear's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q2 2025

    Question

    Uy Ear from Mizuho Financial Group inquired about the gross-to-net dynamics during the quarter, requested elaboration on three recently allowed patents, and asked for clarification on the two ongoing Phase 2 studies mentioned in the presentation.

    Answer

    Chief Financial Officer Latha Vairavan stated that gross-to-net remained stable in the 50s range. President and CEO Frank Watanabe clarified that the new patents strengthen the company's IP portfolio but do not extend the loss of exclusivity. He also specified that the two Phase 2 studies are collaborative research trials for vitiligo and hidradenitis suppurativa (HS), separate from the sponsored registrational trial in pediatric atopic dermatitis.

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    Uy Ear's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q1 2025

    Question

    Uy Ear from Mizuho Securities sought clarification on the expected gross-to-net cadence for ZORYVE throughout the year and questioned what drove the significant market share increase for branded topicals, from 4% to 6% year-over-year.

    Answer

    Todd Edwards, Chief Commercial Officer, explained that gross-to-net, while impacted by deductible resets early in Q1, has returned to a steady state in the 50% range and is expected to improve through the year. CEO Frank Watanabe attributed the branded topical market share growth to the recent availability of superior non-steroidal options like ZORYVE, which offer compelling clinical profiles compared to older, less effective, or tolerability-challenged agents. He noted this trend is accelerating as clinicians rethink their reliance on topical steroids.

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    Uy Ear's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q4 2024

    Question

    Uy Ear of Mizuho Securities asked about the expected label for the upcoming ZORYVE foam approval in psoriasis and the commercial strategy regarding potential cannibalization of the cream. He also inquired about expectations for the Phase 1b data readout for the alopecia areata candidate, ARQ-255.

    Answer

    Chief Medical Officer Patrick Burnett stated he expects a broad psoriasis indication for the foam, specifically calling out scalp involvement, and noted the ARQ-255 data will focus on safety, PK, and early biomarker signals. Chief Commercial Officer Todd Edwards and CEO Frank Watanabe emphasized the strategy is to offer choice and accelerate total ZORYVE growth by converting steroid users, not to cannibalize existing cream prescriptions.

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    Uy Ear's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q3 2024

    Question

    Uy Ear from Mizuho inquired about the potential impact of the Kowa partnership on gross-to-net margins, what Arcutis would want to see from competitor Lilly's CD200R agonist data, and the quantifiable impact of recent hurricanes.

    Answer

    Chief Commercial Officer Todd Edwards stated the Kowa partnership should not impact gross-to-net as it utilizes the same established specialty pharmacy network. Chief Medical Officer Patrick Burnett said positive data from Lilly would further validate the CD200R mechanism, but Arcutis believes its own asset, ARQ-234, will be differentiated. Todd Edwards also noted that the impact from hurricanes was nominal and that the company quickly recovered, as shown by strong volume growth.

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    Uy Ear's questions to Evolus Inc (EOLS) leadership

    Uy Ear's questions to Evolus Inc (EOLS) leadership • Q2 2025

    Question

    Uy Ear of Mizuho Financial Group asked for the specific drivers behind the expected consumer rebound cited in company surveys and sought clarity on the revenue cadence for Q3 versus Q4 needed to meet the revised annual guidance.

    Answer

    President & CEO David Moatazedi clarified he expects an "incremental improvement" rather than a full rebound, driven by lapping a depressed base from the prior year. He explained the stronger back-half forecast is supported by two full quarters of Evolisse revenue and the non-recurrence of the Q2 inventory drawdown, leading to a stronger Q4 than Q3.

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    Uy Ear's questions to Evolus Inc (EOLS) leadership • Q1 2025

    Question

    Speaking on behalf of Uy Ear, Charles asked for more detail on the profile of early Evolysse adopters (e.g., med spas, dermatologists, plastic surgeons). He also sought clarification on the Q1 inventory stocking for Evolysse, questioning if the build was sufficient for all of 2025 or beyond.

    Answer

    CEO David Moatazedi clarified that the initial launch strategy targets existing Evolus customers, with research showing 99% were interested in trialing the product, so the early adopter profile has a high overlap with the current Jeuveau customer base. CFO Sandra Beaver explained that the Q1 inventory stocking mentioned was related to cash use for the initial launch preparation and was not intended to cover inventory needs for the full year or beyond.

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    Uy Ear's questions to Alkermes Plc (ALKS) leadership

    Uy Ear's questions to Alkermes Plc (ALKS) leadership • Q2 2025

    Question

    Uy Ear of Mizuho Financial Group asked if there was a chance the narcolepsy type 2 (NT2) study data would also be presented at the upcoming World Sleep meeting, given enrollment was nearing completion.

    Answer

    Richard Pops, Chairman & CEO, clarified the timeline, stating that after enrollment completes, a two-month primary analysis period places the data readout in the fall. Therefore, the NT2 data will not be available for presentation at the World Sleep meeting in September.

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    Uy Ear's questions to Alkermes Plc (ALKS) leadership • Q1 2025

    Question

    Uy Ear asked for help setting expectations for the upcoming Vibrance-1 data, specifically regarding expected efficacy and safety, and inquired about the effect size assumed for powering the Phase II study.

    Answer

    CEO Richard Pops clarified that the top-line data will focus on primary efficacy endpoints (MWT, Epworth, cataplexy) and a thorough summary of tolerability. He explained that the study's sample size was determined by FDA interactions regarding safety exposure requirements, not an efficacy calculation, and is therefore expected to be highly powered for efficacy.

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    Uy Ear's questions to Alkermes Plc (ALKS) leadership • Q4 2024

    Question

    Uy Ear followed up on Medicaid, asking about the funding sources for VIVITROL, the potential risk from federal cuts, and the impact of the IRA's Medicare Part D redesign on the business.

    Answer

    CEO Richard Pops addressed policy, stating that while Medicaid is important, he believes their medicines are not a primary driver of costs and that the company's exposure to the 2025 Part D redesign is minimal at 1%. CCO C. Nichols specified VIVITROL's payer mix is stable at roughly 50% Medicaid and 45% commercial.

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    Uy Ear's questions to Alkermes Plc (ALKS) leadership • Q3 2024

    Question

    Uy Ear sought to confirm that the 2025 EBITDA reduction is primarily due to the manufacturing and royalty revenue transition rather than a large increase in operating expenses, and asked about the expected EBITDA trend beyond 2025.

    Answer

    An executive, likely COO Blair Jackson, confirmed the understanding was correct, stating the EBITDA change is primarily driven by the revenue transition, with only modest expense increases for strategic investments. Regarding trends beyond 2025, the plan is to continue running a profitable business, with future profitability levels dependent on necessary R&D and commercial investments.

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    Uy Ear's questions to Uniqure NV (QURE) leadership

    Uy Ear's questions to Uniqure NV (QURE) leadership • Q1 2025

    Question

    Uy Ear asked about any key FDA personnel changes between recent meetings, whether the new CBER director alters their pipeline development strategy, and for confirmation that 3-year data will be used for the filing.

    Answer

    CEO Matthew Kapusta confirmed no material changes to their FDA review team. He affirmed they remain encouraged about their other pipeline programs and will generate data over the next 6-12 months. He reiterated that while the primary analysis will be on 3-year data, the totality of the data, including 2-year results, will be important to show consistent trends.

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    Uy Ear's questions to Sarepta Therapeutics Inc (SRPT) leadership

    Uy Ear's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    Leo Watson, on behalf of Uy Ear, asked why patients are flocking to leading centers with full capacity, if those sites might increase their capacity, and if the updated guidance accounts for more infusions at secondary sites.

    Answer

    President and CEO Douglas Ingram explained it's not surprising that patients gravitate toward the world-leading Duchenne sites, which are renowned globally. He confirmed the forward guidance assumes the company will successfully engage and utilize more capacity at the well-trained secondary sites to address the imbalance and meet demand.

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    Uy Ear's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q2 2024

    Question

    Uy Ear asked if any start forms were for patients who had previously aged out of the narrow 4-to-5-year-old label, and requested a definition of the 'declining' ambulatory patients that physicians are prioritizing.

    Answer

    CCO Dallan Murray confirmed that very few patients aged out of the narrow label, and the team will now support them under the expanded label. He explained that 'declining ambulatory' patients, typically in the 9-to-11-year-old range, are being prioritized by physicians, a pattern consistent with all previous exon-skipping launches. CEO Douglas Ingram added that start forms are being received for patients from age 4 into their 30s, with a peak around the 9-11 age range.

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    Uy Ear's questions to Neurocrine Biosciences Inc (NBIX) leadership

    Uy Ear's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q4 2024

    Question

    Uy Ear asked if there was significant INGREZZA volume growth in Q4, if the 2025 guidance assumes benefits from the sales force expansion, and how to think about sales post-2027 after IRA price negotiations.

    Answer

    Chief Financial Officer Matthew Abernethy confirmed there was volume growth in Q4 and that the benefit from the sales force expansion is included in the 2025 guidance. Regarding the post-2027 outlook, he stated that while the company is monitoring developments, there is significant uncertainty around IRA implementation, and the current focus remains on growing the TD market.

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    Uy Ear's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q3 2024

    Question

    Uy Ear of Mizuho asked about the Crinecerfont launch, seeking details on the free goods program, the number of patients in safety extension studies, and the level of initial demand.

    Answer

    CMO Eiry Roberts noted that patient retention in the long-term extension studies is incredibly high, indicating good tolerability and uptake. CCO Eric Benevich explained the free goods program is designed to get patients started on therapy while navigating reimbursement hurdles from commercial payers, who often have new-to-market blocks. He confirmed the program would be available for both commercial and Medicaid patients.

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