or the "Company†), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare through proprietary drug discovery platforms and innovative delivery systems, today highlights significant clinical and regulatory milestones and upcoming value-driving catalysts as the Company advances multiple programs towards potential commercialization. "We have established a leading position. TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (†Cybin†...

Core Insights - Johnson & Johnson is presenting 21 abstracts at the U.S. Psychiatric and Mental Health Congress, focusing on major depressive disorder, treatment-resistant depression, and schizophrenia [1][4] - The company emphasizes its commitment to advancing neuroscience and improving patient outcomes through innovative treatments [2][4] Group 1: Major Depressive Disorder (MDD) - MDD affects approximately 332 million people globally, representing about 5% of the population, with around 21 million adults in the U.S. experiencing at least one major depressive episode in 2021 [7][8] - Current treatments often fail to address the unique symptoms of MDD, with 2 in 3 patients continuing to experience residual symptoms despite standard care [7][8] - Insomnia is a common symptom in MDD, affecting about 60% of patients, which can worsen the quality of life and increase the risk of relapse [8] Group 2: Treatment-Resistant Depression (TRD) - Approximately one-third of adults with MDD are classified as having TRD, defined as inadequate response to two or more oral antidepressants [9][10] - The economic burden of TRD is significant, with many patients cycling through multiple medications without achieving remission [10] - The STAR*d study indicates that after trying a third oral antidepressant, about 86% of patients do not achieve remission [10] Group 3: Innovative Treatments - Seltorexant is an investigational therapy being studied as an adjunctive treatment for MDD with insomnia symptoms, aiming to normalize orexin-2 receptor overactivation [13] - CAPLYTA (lumateperone) is approved for treating schizophrenia and bipolar depression, with a supplemental new drug application under review for its use in MDD [11][12] - SPRAVATO (esketamine) is approved for TRD and MDD with suicidal ideation, having been administered to over 150,000 patients worldwide [12][13] Group 4: Schizophrenia Portfolio - Johnson & Johnson offers a comprehensive portfolio of schizophrenia therapies, including long-acting injectables like INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA [14][36] - These treatments provide various dosing options and are designed to support individual patient needs [14][36]

Core Insights - Neurocrine Biosciences reported total net product sales of $682 million for Q2 2025, reflecting a 17% year-over-year growth, with INGREZZA sales at $624 million and CRENESSITY sales at $53 million [1][5][17] - The company narrowed its 2025 net product sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion [1][6] Financial Performance - Q2 2025 revenues totaled $687.5 million, compared to $590.2 million in Q2 2024, marking a significant increase [5][17] - INGREZZA net product sales grew by 8% year-over-year and 15% sequentially, driven by strong patient demand and a record in new prescriptions [6][17] - CRENESSITY achieved $53 million in net product sales with 664 new patient enrollment forms, indicating robust demand and 76% reimbursement coverage [6][17] R&D and Pipeline Developments - The company initiated a Phase 3 registrational program for NBI-'568, targeting schizophrenia, and presented one-year data on CRENESSITY's efficacy at ENDO 2025 [6][10] - Neurocrine is advancing its neuropsychiatry pipeline, including ongoing programs for major depressive disorder with osavampator [2][6] Operating Expenses and Income - GAAP net income for Q2 2025 was $107.5 million, up from $65 million in Q2 2024, with diluted earnings per share increasing to $1.06 [7][17] - R&D expenses rose to $244.3 million in Q2 2025, reflecting investments in expanding the clinical portfolio [7][10] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $1.8 billion [10][19]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported collaboration revenue of $13.8 million, a 21% increase from Q4 2024 [15][18] - R&D expenses were $22.8 million, reflecting a 68% decrease compared to Q1 2024, and a nearly 40% decrease from Q4 2024 [16][17] - The net loss for Q1 2025 was $62.2 million, down from a net loss of $95.8 million in Q4 2024 [18] Business Line Data and Key Metrics Changes - XERZUVEY was shipped to over 3,000 women with postpartum depression (PPD) in Q1 2025, representing a 22% increase from Q4 2024 [7][12] - The company generated $13.8 million in collaboration revenue for XERZUVEY, which is 50% of the net revenue reported by Biogen, marking a 21% increase from the previous quarter [15][18] - Over 70% of women prescribed XERZUVEY received it as their first new treatment for PPD [12][40] Market Data and Key Metrics Changes - The majority of prescriptions (almost 80%) in Q1 2025 came from OBGYNs, indicating a strong focus on peripartum care [12][26] - The total number of XERZUVEY writers increased by over 20% in Q1 2025 [12] Company Strategy and Development Direction - The company is focused on establishing XERZUVEY as the standard of care for women with PPD and is actively working to expand its reach [6][8] - A strategic alternatives process is ongoing to evaluate opportunities for maximizing shareholder value [6] - The company has recalibrated its R&D approach to prioritize neuropsychiatry and neurodevelopmental disorders, with a focus on SAGE-319 and the NMDA receptor NAM platform [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercialization of XERZUVEY and the potential for significant growth in 2025 [11][18] - The cash runway is expected to support operations until mid-2027, with plans to create shareholder value through focused R&D and commercialization efforts [18][108] Other Important Information - The company has seen a paradigm shift in how healthcare providers are screening, diagnosing, and treating PPD [7][8] - The sales force expansion is complete, and management anticipates continued quarter-over-quarter growth in demand and revenue [12][39] Q&A Session Summary Question: What kind of early pull through are you seeing from your Salesforce initiatives? - Management noted strong first-quarter growth of over 20% in demand and revenue, attributing this to the expanded sales force [25][26] Question: Could you provide some additional color on the pipeline and your upcoming catalysts? - Management expressed confidence in the recalibrated R&D approach and the pharmacology of their drugs, believing they will create significant shareholder value if successful [31][33] Question: What do you believe are the key factors for prescribers and patients deciding not to use XERZUVEY as their first-line treatment? - Management indicated that over 70% of women prescribed XERZUVEY are receiving it as their first treatment, suggesting minimal obstacles to frontline use [40][41] Question: Can you speak about the concentrations of the sales force in particular regions? - Management confirmed that the sales force expansion is complete and they expect continued growth in regions where the sales force has been expanded [39] Question: How should we think about the acceleration in growth in shipments as the quarters progress? - Management reiterated their expectation of quarter-over-quarter growth and noted that they are not providing forward-looking forecasts [56][57] Question: What is the current awareness of XERZUVEY among OBGYNs and the expecting mother community? - Management reported approximately 90% aided awareness among physicians treating PPD, which is considered remarkably high for a product at this stage [65][66] Question: Has anything changed regarding Biogen's commitment to the product? - Management stated that there has been no change in the partnership with Biogen, and both parties are excited about the product's impact [72] Question: What is the persistence of prescribers for XERZUVEY? - Management indicated that once a healthcare provider prescribes XERZUVEY, they tend to become repeat writers, with no significant drop-off observed [114]