Group 1 - The biopharma industry is undergoing significant transformation, driven by the adoption of AI, cloud-native scientific computation, a shift away from animal testing, and increased reliance on model-informed drug development [3] - Simulations Plus is positioning itself to meet the industry's inflection point by enhancing its technology, services, and operating model, thereby strengthening its leadership and building an integrated ecosystem for future innovation [3] Group 2 - The agenda for the Investor Day includes an overview of the company's vision, mission, and values, highlights of company growth, major business components, industry environment, challenges and opportunities in drug development, software product strategy, fiscal year '26 roadmap, and a Q&A session [2] - The company is approaching its 30th anniversary, reflecting on its history of growth and the evolution of its business [2]

Group 1: Collaboration and Expansion - Certara has announced a new collaboration with Merck to expand the use of the Certara Pinnacle 21 software platform, which now includes a metadata repository and data standards workflow management [1][3] - This agreement builds upon an existing technology collaboration aimed at aiding Merck in regulatory submissions [1] Group 2: Data Management Challenges - The complexity of reducing the time from data collection to validated, analysis-ready datasets has increased, with Phase III clinical trials now averaging 3.6 million datapoints, a threefold increase over the last decade [2] - The Certara Pinnacle 21 platform is designed to address the data standardization challenges associated with modern digital trials at scale [2] Group 3: Company Overview - Certara accelerates medicine development using biosimulation software, technology, and services, serving over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries [4]

Certara's Business and Market Position - Certara is a leader in biosimulation, using AI-enabled platforms, data, and scientific expertise to transform drug development and accelerate new medicines to patients[16, 76] - The company serves over 2,400 customers across 70 countries, including 30 of the top 30 biopharma companies[16] - Over 90% of novel drugs approved by the US FDA since 2014 were supported by Certara solutions[16] - The in silico drug development total addressable market (TAM) is $4.1 billion, representing 1.5% of the total R&D industry spend[27] Financial Performance and Growth - Certara's adjusted EBITDA margin in FY 2024 was 32%[17] - Software growth in FY 2024 was 18%[17] - The company's revenue mix is shifting towards software, with software accounting for 42% of revenue in 2024 (including pro-forma Chemaxon revenue of $22.9 million), a 1300 basis point shift since 2021[69, 70] - Certara is investing in its software business to drive sustainable growth, with continued R&D investment to support software innovation and AI integration[71, 74] Biosimulation and its Impact - Biosimulation can save approximately 10 months and $5 million per program[21] - Over 120 novel drugs and 325 label claims were approved by global regulators using Certara technology in lieu of clinical studies[17] - A 3% increase in process efficiency through biosimulation could potentially save approximately $300 million per drug[14]