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SVP & Head of Neurology Kimberly Parkerson described the 8-10 point changes as 'profound,' noting that caregivers had previously identified 1-3 point changes as clinically meaningful. She conveyed the internal excitement and emotion at seeing the durable improvements. CMO Barry Ticho added that the concurrent trend toward greater seizure reduction on the maintenance dose further validates the drug's mechanism of action.

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Chief Medical Officer Hendrik Scholl confirmed they will meet the long-term safety requirement of 300 subjects on drug for 12 months by Q1 of next year by pooling data from the PHOENIX trial. Chairman & CEO Tom Lin added that they are on track with the registration batches and have ongoing CMC discussions with the FDA.

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CEO Gregory Divis explained that while they lack full visibility into competitor data, Avadel sees clear signs of market expansion. He cited adding new prescribers who had never written for oxybates before and bringing back patients who had discontinued prior therapies as evidence. COO Susan Rodriguez added that they are persistently drawing from discontinued and switch patients, driving momentum.

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CFO Thomas McHugh explained that Q1 is always heavily impacted by gross-to-net deductions, resulting in an annualized average net revenue per patient of just under $80,000. He expects a similar percentage improvement from Q1 to Q2 as seen in the prior year and anticipates overall improvement for the full year. CEO Gregory Divis added that the metric will improve as more patients remain on therapy longer at steady doses.

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Executive Gregory Divis responded that the company has not observed a specific geographic pattern for cardiovascular risk and noted that research shows it is not a top-20 comorbidity in narcolepsy. To improve persistency, he outlined a three-part strategy: direct patient engagement via nurses, communication with physician office staff, and collaboration with pharmacy partners. Executive Thomas McHugh added that improving persistency is a key lever for driving revenue growth.

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Co-CEO & Co-Founder Josh Cohen described the call point as adult endocrinologists, with some managing hundreds of PBH patients at academic centers. Chief Medical Officer Dr. Camille Bedrosian detailed the trial's powering, stating it has over 90% power to detect an effect even if it's a conservative 35% reduction versus placebo.

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Co-CEO Joshua Cohen explained that their trial's inclusion criteria are nearly identical to prior successful studies and that hyperinsulinism is a common feature. Co-CEO Justin Klee added that the drug's mechanism directly targets the excessive GLP-1 response that causes severe insulin secretion in PBH. Regarding pricing, Joshua Cohen noted it is too early for specifics but suggested looking at other orphan drug analogs and emphasized the significant quality-of-life impact the drug could have for patients.

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Chief Commercial Officer Thomas Garner stated that Daybue discontinuations remained low, well below 10%. CFO Mark Schneyer reported no significant changes in channel inventory for NUPLAZID and reminded that the concept doesn't apply to Daybue's direct-to-patient model. Mr. Schneyer also explained that the cash tax rate is currently in the mid-teens but will likely go down in the next year or two due to accelerated expensing of capitalized R&D.

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CCO Thomas Garner reported that DAYBUE's compliance rate was in the 'very high 60s,' slightly down from Q4, which may be related to physicians' titration strategies. He noted the patient mix is broad and stable. CEO Catherine Owen Adams added that the company has not observed any correlation between patient age and persistency rates.

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Executive Brendan Teehan confirmed that the flattening persistency curve suggests patients remaining on therapy are benefiting from the treatment, as confirmed by feedback from family access managers. He reiterated that most discontinuations occur early, within the first one or two fills, and are primarily driven by tolerability issues like diarrhea or vomiting, rather than a lack of efficacy.

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President & CEO David Moatazedi clarified that the late-quarter drop was tied to Evolus's quarterly pricing tier program, where customers deferred large volume purchases. He described the July improvement as "incremental" and not a full market rebound, cautioning that macro headwinds remain. He stated that Hugel's impact was not a key driver of Q2 market dynamics.

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CEO David Moatazedi acknowledged the competitor's loyalty program changes but stated that Evolus's share gain assumptions for Q1 already factor in that impact, and the company still believes it outperformed the market. He confirmed that Evolus does not publicly disclose Evolysse's list price but stated it is priced in line with market-leading products. He added that the Evolux loyalty program offers pricing benefits on Evolysse and increased co-branded media spend for accounts purchasing both Jeuveau and Evolysse.

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Chief Executive Officer Dr. Herriot Tabuteau clarified that the 'precision medicine approach' mentioned in prepared remarks referred to solriamfetol for major depressive disorder (MDD), not ADHD. For ADHD, he noted the disease continuum from childhood to adulthood implies that efficacy in adults bodes well for pediatrics.

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Ari Maizel, Chief Commercial Officer, confirmed that a national DTC campaign for Auvelity is planned for later in the year. Regarding AXS-12, he expressed optimism, citing positive feedback on its compelling profile, including daytime dosing and strong efficacy on cataplexy. He acknowledged the enthusiasm for orexins but noted that questions about their safety and tolerability remain.

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Chief Financial Officer Nick Pizzie indicated that R&D spend likely peaked in Q4 2024 and will moderate in 2025, while overall OpEx will increase but at a slower rate than sales. Chief Operating Officer Mark Jacobson explained the AXS-12 filing is gated by the pre-NDA meeting and the work of building the submission, noting it involves the same FDA division as the AD agitation filing.

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CCO Ari Maizel noted Auvelity use remains around 50% first/second-line and 50% monotherapy/adjunct, with improving trends, and confirmed the migraine launch will involve a separate, targeted sales force. CEO Herriot Tabuteau clarified the AXS-12 ENCORE study is not required to be positive for an NDA filing, as its primary purpose is long-term safety data.

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CEO & Board Director Robert Barrow highlighted the unique magnitude and durability of MM120's effect seen in Phase 2 data, which he noted has not yet been demonstrated by other programs in the class. He expressed excitement for the field and confidence in MindMed's pivotal readouts expected in 2026.

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CEO Robert Barrow responded that while it's an exciting time for the field, MindMed's Phase 2 data for MM120 showed a magnitude and durability of effect that has not yet been seen from other programs in the class. He emphasized the company's excitement for its three pivotal trial readouts in 2026, which they hope will replicate these strong, durable results.

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Chief Medical Officer Dr. Dan Karlin explained that the initial MDD trial, Emerge, is a two-arm study (100mcg vs. placebo) but noted a low-dose control might be used in future MDD studies. He affirmed that the 100-microgram dose is being used for MDD based on its demonstrated efficacy against depressive symptoms in the GAD Phase IIb trial.

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CFO Matt Abernethy confirmed that the outlook for similar pricing in 2026 is based on the trajectory at which Neurocrine exits 2025. He also clarified that the negative 5% price impact is a full-year 2025 figure, meaning the price headwind is more concentrated in the second half of the year due to the timing of new contracts.

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Chief Financial Officer Matthew Abernethy declined to provide a specific net revenue per script number but guided that gross-to-net would be 'sequentially down just slightly' in Q2 versus Q1. Chief Medical Officer Dr. Eiry Roberts detailed the rest of the muscarinic pipeline, noting that the dual M1/M4 agonist NBI-'570 is on track to begin a Phase II study in acute psychosis by the end of the year.

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Chief Financial Officer Matthew Abernethy clarified his earlier comment was about a potential Q1 2025 ordering pattern phenomenon due to the calendar, not a Q4 inventory build. Chief Medical Officer Eiry Roberts explained that NBI-570 is a selective dual M1/M4 agonist, unlike Karuna's pan-muscarinic drug. This selectivity avoids M2, M3, and M5 receptors, which she anticipates will result in a different side effect profile without requiring a co-formulated peripheral agent.

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CCO Eric Benevich acknowledged that both brands are growing in an expanding market and that the competitor's growth was expected with its new formulation. However, he reinforced that INGREZZA remains the most prescribed VMAT2 inhibitor. He cited the recent sales force expansion in psychiatry and long-term care as a testament to Neurocrine's conviction in INGREZZA's long-term growth opportunity.

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Marcus Yountz, VP of Clinical Development, clarified that the learnings relate to the operational implementation of the cataplexy assay, such as standardizing patient recording to reduce variability. Richard Pops, Chairman & CEO, reiterated confidence in the cataplexy signal and deferred questions on the time course of AEs to the World Sleep presentation.

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Todd Nichols, CCO, stated that VIVITROL is not seeing an impact from federal funding changes, as the business has been re-engineered to focus on the alcohol dependence indication. He also confirmed LYBALVI continues to see healthy growth with no impact from competitors, noting that market data shows Cobenfy is used primarily as an adjunctive therapy and does not directly compete.

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CEO Richard Pops stated that specifics on the next-gen orexin indications will be shared after initial clinical studies are complete. On business development, he said the company is always looking for clinical-stage neuroscience assets and ways to leverage its commercial infrastructure but feels no urgency and has a high bar for potential deals.

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CEO Richard Pops described the base case for VIVITROL post-2027 as maintaining promotional support against a single entrant, not a typical generic erosion, given the market's growth dynamics. He stated that while the company will manage for profitability, future EBITDA growth depends on annual assessments of pipeline and market needs. He refuted the idea that buybacks signal a lack of BD options, stating the company has ample firepower but maintains a high bar for diligence.

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Bruce Cozadd, Chairman and CEO, declined to speculate on hypothetical scenarios, stating the impact would depend on specific tariff rates and affected geographies. He reiterated that the company is well-positioned for 2025 due to its inventory strategy and has effective mitigation options for its oxybate products through its U.S. supplier.

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Bruce Cozadd, Chairman and CEO, addressed the Epidiolex settlement, stating that while confidentiality prevents disclosing the exact date, the agreements with all 10 ANDA filers extend to the "very late 2030s." Robert Iannone, EVP and Global Head of R&D, noted there were no new updates on the JZP-441 trial but confirmed it is designed to help define a better therapeutic index.

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CEO Bruce Cozadd stated the Epidiolex settlements with all 10 ANDA filers extend to the "very late 2030s" but could not be more specific due to confidentiality. EVP, Global Head of R&D Rob Iannone provided no new updates on the JZP-441 trial but noted it will help define a better therapeutic index.

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EVP, Global Head of R&D, Rob Iannone, stated that the orexin field is still evolving and a best-in-class profile remains undefined, citing potential safety issues like hepatic toxicity and visual disturbances as key differentiators. He confirmed that Jazz plans to initiate a Phase Ib trial for JZP441 in narcolepsy type 1 patients in the first half of 2025 to assess its therapeutic window and inform future development.

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EVP, Global Head of R&D Robert Iannone commented that the orexin field is still early and the ideal best-in-class profile is not yet defined, highlighting potential differentiators like hepatic safety and half-life. For JZP441, he confirmed a Phase Ib study is planned for the first half of 2025 in NT1 patients to evaluate its therapeutic index and inform future development.

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President and CEO Christopher Viehbacher emphasized that SPINRAZA competes on efficacy in a crowded market. He highlighted the upcoming high-dose formulation and a novel port device (expected ~2026) as key future drivers to enhance patient experience. CFO Michael McDonnell added that there were no material inventory or channel dynamics to report for the quarter.

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CEO Christopher Viehbacher explained that in Europe, patient demand is generated through early access programs while country-by-country reimbursement is negotiated. This leads to lumpy revenue recognition. The dynamic mentioned refers to revenue adjustments for early access programs where the final negotiated price may be lower than the initial price charged.

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CEO Barry Greene clarified that the flat revenue despite demand growth was a function of channel inventory management, not a change in gross-to-net. Regarding retreatment, he stated that real-world performance is mirroring the rapid and durable response seen in clinical trials, and the company is not observing significant, if any, need for retreatment with a second 14-day course.

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CEO Barry Greene stated that Sage remains open to external business development but has found target assets to be expensive. On inventory, Chief Business Officer Chris Benecchi said levels have normalized after the initial launch build and that the strong Q3 revenue growth was primarily driven by a ~40% increase in demand (shipped units).

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CEO Ian Mortimer explained that the Phase III MDD studies (X-NOVA2, X-NOVA3, X-NOVA4) will run in parallel, similar to the epilepsy program, but with a natural stagger between their initiations. He confirmed that the start of subsequent trials is not gated by the outcomes of the earlier ones. The immediate focus is on initiating the X-NOVA2 study.

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The company has strong momentum from Q4's 10% prescription growth but expects typical Q1 seasonal headwinds from insurance changes and deductible resets. Growth is expected to reaccelerate in Q2. The response did not provide details on the new DTC campaign.

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The gross-to-net deduction for ZTALMY is consistently just under 20%. The company believes the addressable pediatric patient population of 2,000 is achievable, with ICD-10 codes suggesting over 800 patients and growing. They are also seeing an upside from adult patients being treated. The response did not directly address off-label use but focused on the on-label population.

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President and CEO Dr. Todd Brady explained that the RASP modulation platform targets a family of inflammatory mediators rather than a single protein, which contributes to a favorable safety and tolerability profile. He stated that in trials to date involving approximately 110 patients, ADX-629 has demonstrated very few side effects and no serious adverse events deemed related to the drug.

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President and CEO Dr. Todd Brady explained that while the dry eye market has new entrants, it remains a significant unmet medical need. He emphasized that reproxalap is uniquely positioned as the only novel drug with a new chemical entity and target. Dr. Brady highlighted its key differentiator: a rapid onset of action, providing symptomatic improvement within minutes, which will be the central focus of their commercial positioning.

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CEO Dr. Todd Brady explained that while a generic RESTASIS means payers will likely require a step-through, many patients have already failed the drug. Aldeyra aims to position reproxalap as the branded drug of choice, citing head-to-head trial data showing superiority over Xiidra in tolerability and symptom protection. He clarified that the commercial lead, Kelly Mizer, is leading business development and partnering discussions, which are focused on label positioning and branding.

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CEO Dr. Vlad Coric reported that patient durability on NURTEC ODT is strong, with refill rates reflecting monthly migraine frequency. Regarding Verdiperstat, Dr. Coric and CMO Dr. Elyse Stock clarified that the negative MSA trial does not have a direct read-through to the ALS study due to different underlying disease pathologies. They remain optimistic about the ALS trial, which targets neuro-inflammation and is nearing enrollment completion.

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CEO Vlad Coric stated that building the market is the top priority and that affordability programs are continuously tweaked based on incoming data. He acknowledged that favorable pricing improvements occurred sooner than expected but warned of potential volatility as the dual indication is still in its launch phase. He suggested a more stable view would emerge by year-end.

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CEO Vladimir Coric explained that the improved GTN resulted from successfully modifying affordability programs to convert more non-paying to paying customers, but he cautioned about future volatility. CFO Jim Engelhart attributed higher spending to factors like stock-based compensation and the timing of brand investments, suggesting the non-GAAP view offers better clarity.

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