Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $103.6 million, representing a year-over-year growth of 3% on a reported basis and 2% on a constant currency basis [18] - For the full year 2025, total revenue was $418.8 million, reflecting a year-over-year growth of 9% on a reported basis and 8% on a constant currency basis [18] - Adjusted EBITDA for Q4 2025 was $32.5 million, a decrease from $33.5 million in Q4 2024, with an adjusted EBITDA margin of 31% [23] - Net loss for Q4 2025 was $5.9 million, compared to net income of $6.6 million in Q4 2024 [24] - Adjusted diluted earnings per share for Q4 2025 was $0.09, down from $0.15 in the same quarter last year [25] Business Line Data and Key Metrics Changes - Software revenue in Q4 2025 was $46.4 million, up 10% year-over-year, driven by MIDD software and Pinnacle 21 [19] - Services revenue for Q4 2025 was $57.3 million, down 1% year-over-year [21] - Software bookings in Q4 2025 were $56.1 million, down 6% from the prior year period [20] - MIDD services bookings saw double-digit growth in Q4, led by Tiers 2 and 3 [22] Market Data and Key Metrics Changes - The pharmaceutical industry is spending over $200 billion annually on drug development, with timelines extending to 10-15 years [7] - Certara has over 2,600 customers and 23 regulatory agencies using its technologies [9] Company Strategy and Development Direction - The company aims to sharpen operations, focus investments, and execute with greater discipline to capture market opportunities [6] - Certara plans to enhance AI integration and focus on core R&D technologies and model-informed drug development (MIDD) [15] - The company is undergoing a strategic review of its regulatory writing and operations business to maximize long-term shareholder value [13] Management's Comments on Operating Environment and Future Outlook - Management expects flat to low single-digit revenue growth for 2026, reflecting market conditions and planned operational improvements [16] - The company believes it can achieve double-digit growth over time, contingent on improved execution and market acceptance of its technologies [9][31] - Management is optimistic about the strengthening market and better-than-expected spending commitments from customers [46] Other Important Information - Certara repurchased approximately 3.3 million shares for $43 million during 2025 [25] - The company has identified approximately $10 million in cost avoidance for 2026 compared to prior planning [23] Q&A Session Summary Question: What attracted you to Certara and how do you view its differentiation? - The new CEO sees Certara as an undervalued gem with significant growth potential, given its strong market position and regulatory relationships [31][33] Question: How does the platform approach factor into the customer-centric strategy? - The CEO emphasized the importance of serving existing users while also enhancing engagement at senior levels to drive innovation [35] Question: Can you break down the revenue guidance for 2026? - The guidance reflects low single-digit growth due to stable end markets and a deceleration in software bookings [42] Question: What are the opportunities for AI enablement? - AI is being actively embedded into core assets, with a focus on enhancing both product offerings and operational efficiency [54][56] Question: What are the lowest hanging fruit in revamping the commercial organization? - Immediate focus areas include pricing, customer centricity, and optimizing relationships with clients [60]

Core Insights - Teva Pharmaceuticals and Medincell announced FDA approval for UZEDY® (risperidone) as a once-monthly extended-release injectable for the maintenance treatment of bipolar I disorder (BD-I) in adults, addressing unmet needs in mental health treatment [1][3][4] - UZEDY is the first subcutaneous long-acting formulation of risperidone, utilizing proprietary SteadyTeq™ technology for controlled release [2][5] - The approval is based on existing clinical data and Model-Informed Drug Development (MIDD) methodologies, leveraging previous findings on risperidone's safety and efficacy [1][3] Company Overview - Teva Pharmaceutical Industries Ltd. is a leading biopharmaceutical company with a strong commitment to neuroscience and innovative medicines, having over 120 years of experience [12] - Medincell is a biopharmaceutical licensing company focused on developing long-acting injectable drugs, with proprietary BEPO® technology for controlled drug delivery [17] Product Details - UZEDY is now approved with three dosing options: 50 mg, 75 mg, and 100 mg, and is indicated for use as monotherapy or adjunctive therapy to lithium or valproate [2][5] - The product was previously approved for the treatment of schizophrenia in adults in 2023, highlighting its versatility in treating complex mental health conditions [3][4] Market Impact - An estimated 1% of U.S. adults (over 3.4 million) will develop BD-I in their lifetime, indicating a significant market opportunity for UZEDY [3][5] - The introduction of long-acting injectables like UZEDY is seen as a key driver of innovation in central nervous system (CNS) therapeutics, potentially improving treatment adherence and outcomes for patients [3][4]

Core Insights - Certara, Inc. has received formal qualification from the European Medicines Agency (EMA) for its Simcyp® Simulator, marking it as the first company to achieve this for a PBPK modeling platform [1][2] - The qualification allows sponsors to use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk, streamlining the drug submission process [2][3] - The recognition reflects Certara's scientific leadership and innovation in biosimulation, which is increasingly prioritized in drug development [3] Company Overview - Certara accelerates medicine development through biosimulation software and services, serving over 2,400 clients including biopharmaceutical companies and regulatory agencies in 70 countries [4]