A：The current commercialized products have the potential to achieve multibillion dollars in annual peak sales.

A：The key milestones include the acceptance of the S and D filing and the receipt of Priority Review designation with a PDU action date of April 30. If approved, ovality could address a prevalent and debilitating condition for which only one product is currently approved.

A：The planned Phase III trial of a new product candidate is advancing, with the Phase I trial for smoking cessation set to begin in the second quarter, followed by a trial for narcolepsy. The new indications include ADHD, fibrous disorder, MDD with symptoms of excessive daytime sleepiness, and shift work disorder.

A：The outcome of the Type B meeting was reaching an agreement on the plan for Phase II studies in pediatric patients. The company plans to conduct parallel Phase II trials for children and adolescents and has initiated startup activities for a Phase II trial of the new product candidate in MDD patients with symptoms of excessive daytime sleepiness and binge eating disorder.

A：Axs 14 has initiated a forward study of Phase II double-blind placebo-controlled randomized withdrawal trial in patients with fibromyalgia. A 17, the new designation for a compound, is being evaluated for the treatment of epilepsy and has demonstrated a favorable safety profile in over 700 patients. Phase Ii trial enabling activities are underway.

A：The recent financial report indicates strong performance with total product revenue of $155.1 million for the fourth quarter and $579.1 million for the year, robust Avadi growth, and solid contributions from other products like C.O.I and Z Bravo.

A：General and administrative expenses were $169.3 million for the fourth quarter and $570.6 million for the full year of 2025.

A：The company ended the year with $323 million in cash and cash equivalents.

A：The company plans to deliver upon the opportunities for its portfolio of CNS medicines, starting with alvaldi, through planned investments for cycling and the power of its innovative digital-centric commercialization model.

A：Formulary access for Axiom's products remained strong, with commercial coverage increasing from script to script and bringing total coverage to 86% of all lives across channels.

A：The company's strategy for scaling growth across its commercial organization includes expanding adoption of its important CNS medicines.

A：The new FDA publication on the one-trial policy has implications for the company's trials, and the team is assessing it. The company vets its clinical plans with the FDA and will continue to do so, assessing if changes are needed.

A：The pediatric patient subsegment being studied in the ADHD studies are individuals less than 12 years of age, which is the adolescent population.

A：The development plan for Axs Eds involves moving into epilepsy, drawing on safety data from past studies in generalized anxiety disorder. Preclinical studies in FSC models have shown predictive success related to epilepsy, and the company is working towards phase II readiness while closely assessing various epilepsies. Further details on the specific epilepsy indication to target first will be provided over the balance of the year.

A：The addition of the Ada label in April is expected to generally mirror existing Medicare coverage for the new indication. However, the company has been working closely with Medicare Part D plans to ensure coverage and utilization management to support the uptake of the product.

A：The company anticipates a stronger launch in the first year for Axs Eds in Alzheimer's agitation in terms of prescription volume and sales compared to the current market. They plan to share additional details about their program efforts later in the year. They expect 70% plus scripts for Ada to be written in the Medicare Part D channel, which has a more favorable gross-to-net (GTA) profile due to no copay card utilization.

A：The company's growth in the OSA and narcolepsy markets was driven by positive growth in new patient starts, total active writers, and total prescriptions. The company's strategy over the past couple of years has been to increase depth across existing co-prescribing practices. Growth was observed across various segments, including PCP, pulmonologists, sleep specialists, and neurologists.

A：The national TV campaign launched late in the year around September and October has had a positive impact, resulting in inflection in new patient starts. The company has optimized their spend based on the analysis of the impact by media channel for 2020. Growth was observed across all segments, with primary care being the fastest-growing segment in terms of new patient starts and new writers. The company expects this trend to continue as they expand their efforts in the primary care setting.

A：The company expects the ultimate reimbursement and market access at steady state for Axs Eds to be around 82% coverage of lives, similar to the COI percentage covered lives, for both MDD and chronic agitation once the product is approved. However, they also anticipate that it could go meaningfully higher and are looking to define the ultimate optimal range for reimbursement and market access.

A：The company's goal is to try to secure access for as many patients as possible across various channels and they expect to continue working to ensure access for both the mFDA and FDA vacation.

A：The company will focus on the initial indication of epilepsy and look at other potential indications but wants to stay focused on this area based on promising preclinical work.

A：The company is expanding their sales force to increase research frequency and engage with a larger group of healthcare professionals (HCPs) across specialties, which includes primary care, psychiatry, and neurology. This expansion is expected to enable capitalizing on the momentum created in the primary care segment and will allow engagement with an expanded target universe. The company anticipates operating leverage into 2026 despite the hiring of additional reps.

A：The contract with the third large GPO is seen as a precursor to negotiating with payers and PBMs to secure coverage. The team is engaged with national payers and PBMs, and there is optimism about increasing coverage. This is a primary focus for the year, and the team will share updates as the year progresses.

A：The company expects the GTN to remain elevated during the launch phase and to be north of the current GPO coverage but less than the GPS that is prevalent in the space.

A：The company plans to be ready for a potential Alzheimer's therapy launch within a quarter on Ada, and the team is preparing for launch readiness. They are optimistic about the potential impact if approved. The company will share details about the launch progress using typical IQVIA or Symphony data, although they haven't finalized their plans.

A：ASX Xi is seen as a compelling treatment option for narcolepsy patients, particularly for cataplexy relief, based on a new mechanism of action. There is a high degree of interest in using it for narcolepsy patients according to market research. The company recognizes the variability in patient response and the need for trial and error in treatment.

A：The company acknowledges that their asset may be less sedative than benzodiazepines, as shown in an earlier study. However, the therapeutic window is acceptable given the change in indication, and there is a consideration to possibly adjust the dose to optimize sedation levels.

A：The goal of exploring different doses for the drug is to find the best risk-benefit profile for the therapeutic indications by ensuring the selected dose can hit certain subsets of receptors related to specific therapeutic goals.

A：The next step for the drug in clinical trials for epilepsy is to gather information from the initial trial in patients with epilepsy and to continue research to understand the drug's efficacy and safety profile in this therapeutic area.

A：The company anticipates that the safety profile of the drug will be described in the label based on the patient population studied. They expect that the drug's advantages over competitors will include rapid onset of action, durability of response, low side effects, and its differentiation from antipsychotic options, especially in the context of comorbidity with Alzheimer's agitation.

A：Axi 12 is anticipated to be a standard review, not a priority review. The company expects that 70% or more of prescriptions for Axi 12 would be in the Medicare Part D channel, which is more favorable than the commercial channel, potentially leading to a more favorable GTC (Gross to Channel) ratio.

A：The company plans to deploy its sales force with an understanding that about 60% of prescriptions for Alzheimer's disease are in community-based settings and 40% in long-term care facilities. If Axi 12 is approved for ADP, the company views Alzheimer's dementia and Alzheimer's psychosis as distinct indications and expects a clear differentiation in the market with significant unmet need for managing agitation symptoms.

A：Primary care is the dominant specialty in overall volume but psychiatrists have the greatest volume per patient. While 1/3 of the company's writer base is in primary care and 2/3 in psychiatry, the future penetration in the neuropsych segment versus the primary care segment is not yet clear, but the company is seeing growth in primary care with its expanding sales team.

A：Axi 12 sees an opportunity in the treatment of narcolepsy with the potential entry of orexin-based products, acknowledging that there's a need for polypharmacy due to the trial and error involved in treating the condition. Axi 12 has strong data in cataplexy and daytime dosing, and feedback indicates positive effects on functional scores. Mechanistically, Axi 12 targets norepinephrine, which is in the same pathway as orexin-based products, offering potential advantages in treating comorbidities like depression. Axi 12 is excited about the potential impact on cognition and the overall safety and tolerability profile.