Summary of Simulations Plus Investor Day - January 21, 2026 Company Overview - **Company**: Simulations Plus (NasdaqGS:SLP) - **Industry**: Biopharmaceutical modeling and simulation - **Focus**: Drug development, commercialization, and scientific consulting Core Points and Arguments Industry Transformation - The biopharma industry is undergoing significant changes, including: - Adoption of AI - Shift towards cloud-native scientific computation - Move away from animal testing - Increased reliance on model-informed drug development [2][12][50] Company Vision and Mission - **Vision**: Improve quality of life through innovative solutions - **Mission**: Create value for clients by accelerating the discovery, development, and commercialization of pharmaceuticals through science-based software and consulting solutions [3][2] Unique Value Proposition - Simulations Plus differentiates itself through: - A combination of scientific excellence and technological innovation - A robust suite of software products including GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, and Thileys [4][5] - The company is evolving from point solutions to an integrated cloud-enabled ecosystem [5] Market Opportunity - Total Addressable Market (TAM) is approximately $12.5 billion: - $4 billion in traditional biosimulation - $8.5 billion in clinical trial training and medical communications [6] Client Needs and Industry Pressures - Clients face pressures from: - Economic factors increasing the cost and complexity of drug development - Scientific complexity requiring advanced modeling techniques - Technological expectations for integrated digital infrastructure [10][11][12] Regulatory Environment - Regulatory agencies are pushing for broader use of model-informed drug development and non-animal methodologies, which aligns with Simulations Plus's offerings [12][56] Strategic Shift - The company is transitioning from a tool provider to an ecosystem partner, focusing on integrated workflows and AI-assisted solutions [14][28] Additional Important Insights Product Strategy and Roadmap - The company is building a unified AI-orchestrated ecosystem that connects various aspects of drug development [20][25] - The architecture includes: - Validated modeling engines - Composition layer for data standardization - Grounded intelligence layer with AI copilots - Orchestration layer for automating workflows [21][22][24] Services and Consulting - Simulations Plus's services complement its product offerings by providing scientific consulting that informs software enhancements and optimizes workflows [33][34] - The consulting teams help clients navigate complex drug development decisions, reducing uncertainty and costs [34][35] Case Studies - Case studies illustrate the effectiveness of Simulations Plus's approach in reducing development timelines and costs while improving clinical trial success rates [41][43] Future Growth and Revenue Opportunities - The acquisition of Pro-ficiency has doubled the TAM and is expected to contribute to future growth [54][55] - The company anticipates increased demand for simulation and modeling services driven by FDA's NAMs guidance [56][58] Pricing Evolution - The company is evolving its pricing strategy to reflect the added value of its integrated ecosystem, with new monetization opportunities expected as the ecosystem matures [29][30] Conclusion - Simulations Plus is well-positioned to lead in the evolving landscape of model-informed drug development, leveraging its scientific expertise, technological innovations, and strategic partnerships to create a cohesive platform that meets the industry's growing demands [53]