Uy Ear

Uy Ear from Mizuho Securities asked for clarification on the Q4 2025 quarter-over-quarter growth breakdown, specifically the 8% attributed to price, and whether this price benefit is expected to continue. He also inquired about the factors enabling Arcutis to secure Medicare Part D access for one-third of recipients and the timeline for gaining access to the remaining plans.

Answer

Chief Commercial Officer Todd Edwards confirmed the Q4 growth breakdown, explaining the price upside was due to patients moving quicker through deductibles, reducing co-pay card expenses. He anticipates gross-to-net improvement throughout 2026 as deductibles are met. Regarding Medicare Part D, Todd Edwards cited strategic pricing and ZORYVE's differentiated profile, along with significant commercial volume uptake, as key factors. President and CEO Frank Watanabe emphasized the rarity of branded products on Part D formularies. They expect to gain access to the remaining Part D plans by early 2027.

Uy Ear asked for a breakdown of the 29% quarter-over-quarter growth in Q4 2025, specifically the contribution from Rx, inventory, and price, and how the price benefit is expected to continue. He also asked about the strategy for gaining Medicare Part D access for the remaining two-thirds of recipients.

Answer

Todd Edwards, Chief Commercial Officer, confirmed the Q4 growth breakdown: 19% from volume, 2% ($2.5 million) from channel inventory build (expected to unwind in Q1), and the remainder from price upside due to patients meeting deductibles faster, reducing co-pay card expenses. He noted that gross-to-net will improve through the year as patients reach out-of-pocket maximums. For Medicare Part D, he cited strategic pricing and ZORYVE's differentiation/significant commercial volume uptake as reasons for securing one-third access. He anticipates gaining access for the remaining Part D plans by Q1 2027, while diligently working to pull it forward. Frank Watanabe, President and CEO, emphasized the significance of gaining branded product access on Part D formularies.

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.

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.

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.

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.

Uy Ear from Mizuho Financial Group inquired about the strategic direction for NDV-01 following its encouraging six-month data and a competitor's recent approval, questioning the focus between high-grade versus low-to-intermediate-grade bladder cancer. He also asked about the objectives for the upcoming FDA meeting, the potential risks of each clinical path, and the rationale behind the recent significant decrease in R&D spending.

Answer

Chief Medical Officer, Dr. Raj Pruthi, explained that while NDV-01 shows strong efficacy in high-grade disease, the low-to-intermediate-grade market presents a larger, potentially faster path to approval, citing UroGen's success as a precedent. He stated the primary goal of the FDA meeting is to discuss the viability of a similar single-arm study design. CEO Sergio Traversa clarified that the drop in R&D spending is temporary, reflecting a period without active patient enrollment, and confirmed expenses will increase in 2026 with the initiation of new trials.

Uy Ear of Mizuho Securities asked about Relmada's confidence in the FDA accepting the current Phase II data for NDV-01 for a registrational study, plans for scaling up manufacturing, and how NDV-01 will be positioned in a crowded bladder cancer market.

Answer

Executive Sergio Traversa expressed confidence in the FDA path for NDV-01, citing the well-established efficacy of the gemcitabine/docetaxel combination, the significant practical advantages of the new formulation, and its strong safety profile. Dr. Yair Lotan, a clinical expert on the call, added that NDV-01's ease of use addresses a major hurdle for urologists and that its sustained release could improve efficacy. Regarding competition, Dr. Lotan noted that while the BCG-unresponsive space is busy, NDV-01 has strong potential in the less crowded intermediate-risk and BCG-naive spaces. Sergio Traversa also confirmed plans to secure a second manufacturer for commercial scale-up and risk management.

Uy Ear of Mizuho Securities asked about the competitive process for acquiring NDV-01, why Relmada was chosen as the partner, and what data to expect from the upcoming AUA meeting.

Answer

Executive Sergio Traversa explained that the NDV-01 deal was competitive, but Relmada's strong development capabilities, focused attention, and partnership approach were key differentiators. CFO Maged Shenouda added that Trigone shareholders also became Relmada shareholders, participating in the upside. Regarding the AUA meeting, Traversa noted that the abstract will not contain data as it's being collected in real-time, but mentioned a 75% complete response rate at 3-4 months is a competitive benchmark. Shenouda cautioned against speculating on specific data points before the official release to respect conference rules.

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.

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.

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.

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.

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.

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.

Uy Ear asked if there were key FDA personnel changes between recent meetings, how the new CBER director might affect the broader pipeline, and sought confirmation that 3-year data would be used for the AMT-130 filing.

Answer

CEO Matthew Kapusta stated there have been no material changes to the FDA review team they interact with. He reiterated excitement for the entire pipeline. He also clarified that while the totality of data is important, the 3-year data is a key focus because 24 patients will have reached that milestone, making it a substantial dataset for analysis.

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.

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.

Uy Ear from Mizuho Securities asked about the gross-to-net percentage for ZURZUVAE and whether it experienced typical first-quarter pressure.

Answer

COO Chris Benecchi explained that while Sage has not disclosed the specific gross-to-net percentage, it does not require the same level of discounting as other antidepressants due to its novelty. He confirmed that because ZURZUVAE's payer mix is primarily commercial and Medicaid, it does not experience the typical Q1 gross-to-net fluctuations associated with Medicare resets.

Uy Ear inquired about the status of the collaboration with Shionogi in Japan, including the potential for milestones from their pending MDD application and the overall market opportunity.

Answer

CEO Barry Greene confirmed that their partner Shionogi expects a regulatory decision on the MDD application in Japan later in the year. COO Chris Benecchi specified that Sage is entitled to approximately $55 million in regulatory milestones, a portion of which would be due upon approval, plus additional commercial milestones. He clarified that none of these potential payments are included in the current cash runway guidance to mid-2027, representing potential upside.

Uy Ear requested an elaboration on Zurzuvae's payer coverage, particularly with Medicaid state reviews, and asked for the number of prescriptions written in the third quarter.

Answer

CEO Barry Greene noted the company now reports shipments and revenue, not prescriptions. Chief Business Officer Chris Benecchi stated that over 90% of commercial and Medicaid lives are covered, with the vast majority of policies enabling first-line access without burdensome prior authorizations. He confirmed all three national PBMs now have favorable coverage.

Uy Ear asked about the expected shape of the ZURZUVAE launch curve in the second half of the year, given the significant progress on payer coverage.

Answer

CEO Barry Greene pointed to strong coverage and the planned Q4 sales force expansion as key drivers. He anticipates an 'uptick' in performance, especially in territories where new resources are added, as they continue to capitalize on the momentum with OB/GYNs and head into the new year.

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.

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.

Asked for an update on market share gains for DAXXIFY and RHA, the contribution of the new lip product to RHA's growth, and for clarification on the total number of aesthetic accounts.

Answer

The company corrected its press release, stating it ended Q2 with over 8,000 aesthetic accounts and over 4,200 DAXXIFY accounts. While not providing specific market share numbers, management stated that strong revenue growth for both DAXXIFY and RHA (15% in a soft market) implies continued share gains. It's difficult to quantify the lip launch's specific contribution to RHA's growth, but it was helpful in driving broader engagement.

Uy Ear from Mizuho Securities inquired about any conditions that might cause Selecta to reverse its decision to partner its pipeline assets and asked for clarification on the future trajectory of R&D spending.

Answer

Executive Blaine Davis affirmed the company believes the announced strategy is the best path forward. He explained that while reported R&D expenses include reimbursed SEL-212 activities, the net R&D spend is expected to decrease through the second half of 2023 and into 2024 as part of the new strategic focus.

Uy Ear requested more detail on the decision to deprioritize the IgA nephropathy program, asking what had changed in the company's evaluation. He also asked what the company's cash runway would be if the anticipated milestone payment for SEL-212 was excluded from projections.

Answer

CEO Carsten Brunn explained that the decision was a matter of resource allocation, choosing to prioritize ImmTOR IL due to its potential across multiple, sizable indications over the single-indication IgA protease asset. CFO Blaine Davis addressed the cash runway question by stating the company is highly confident in achieving the milestone, which is part of what extends the runway into the second half of 2025. Therefore, he declined to provide guidance without it.

Uy Ear requested more detail on the decision to deprioritize the IgA nephropathy program and asked what the company's cash runway would be without the anticipated SEL-212 milestone payment.

Answer

CEO Carsten Brunn clarified that the IgA nephropathy decision was a strategic choice to allocate resources to the broader ImmTOR IL platform rather than a single-indication asset. CFO Blaine Davis expressed high confidence in receiving the milestone payment and declined to provide a runway calculation without it, confirming the guidance to H2 2025 includes this specific milestone.

Uy Ear requested more details on the decision to deprioritize the IgA nephropathy program and asked what the company's cash runway would be without the anticipated milestone payment from the SEL-212 program.

Answer

CEO Carsten Brunn explained the decision was a matter of resource allocation, prioritizing the multi-indication potential of ImmTOR IL over the single-indication IgA protease program. CFO Blaine Davis expressed high confidence in achieving the milestone payment and stated it was already factored into the cash runway guidance to H2 2025, declining to provide a hypothetical runway without it.

Uy Ear of Mizuho Securities asked for more details on the decision to deprioritize the IgA nephropathy program and questioned what the company's cash runway would be without the anticipated SEL-212 milestone payment.

Answer

CEO Carsten Brunn clarified that the IgA nephropathy decision was a matter of resource allocation, favoring the multi-indication potential of ImmTOR IL. CFO Blaine Davis expressed high confidence in receiving the milestone payment, stating it is integral to the H2 2025 runway guidance and that the company would not provide guidance without it. Davis also noted the milestone is expected well before the runway period ends.

Uy Ear from Mizuho inquired about the level of patient interest in the ongoing MMA gene therapy trial and asked for insight into how to model R&D expenses for 2023, given the completion of the DISSOLVE studies.

Answer

Chief Medical Officer Peter Traber reported significant patient interest in the MMA trial, with the first subject currently in the screening process. CFO Blaine Davis explained that while specific guidance isn't provided, R&D expenses in 2023 will see a shift from the late-stage SEL-212 program toward increased activity in preclinical programs and the ongoing MMA study.

Uy Ear from Mizuho inquired about the level of patient interest in the ongoing MMA gene therapy study and asked for guidance on R&D expenses for 2023 following the completion of the DISSOLVE trials.

Answer

Chief Medical Officer Peter Traber reported significant patient interest in the MMA trial, noting the first subject is currently in the screening process. CFO Blaine Davis explained that while specific R&D guidance isn't provided, expenses will shift. Costs for the SEL-212 program will continue, while spending on preclinical activities and the ongoing MMA study will ramp up, leading to a change in the allocation of R&D resources in 2023.

Uy Ear of Mizuho asked for a comparison between Selecta's DISSOLVE trials and Horizon's MIRROR study, particularly regarding patient populations and efficacy. He also inquired about the future outlook for R&D expenses.

Answer

President and CEO Carsten Brunn differentiated the studies by highlighting that the MIRROR trial has more restrictive exclusion criteria, targeting a smaller patient subset, whereas SEL-212 has a simpler dosing regimen. CFO Kevin Tan stated that R&D expenses, which were lower due to DISSOLVE enrollment completion, are expected to gradually increase as the MMA trial and other programs advance.