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]