Certara, Inc. (NASDAQ: CERT)

Certara, Inc. is a global leader in biosimulation science, technology, and consulting services, specializing in Model-Informed Drug Development (MIDD) for the biopharmaceutical and biotech industries. The company leverages biological and statistical models derived from preclinical, clinical, and evidence data to inform decision-making in drug research, development, and commercialization. Biosimulation, a critical component of MIDD, uses computer-aided mathematical simulation of biological processes to understand the action of a drug in the human body or a population of humans. This approach aims to increase the probability of success in bringing new drugs to market, accelerate development, and decrease costs.

Certara generates revenue through a combination of proprietary biosimulation platforms, software applications, and consulting services. The company's primary products include the Simcyp Simulator, Phoenix PK/PD suite, and Certara.AI, among others. These offerings cater to a diverse customer base, including life sciences companies of all sizes, contract research organizations, academic and government institutions, and global regulators. The company's software products are licensed by more than 160,000 users and are also used by 20 global drug regulatory agencies, including the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and China's Center for Drug Evaluation (CDE) within the National Medical Product Administration (NMPA).

• Biosimulation Solutions: Certara's biosimulation solutions are designed to predict both pharmacokinetics (how the body interacts with drugs) and pharmacodynamics (how a drug affects the body). The company offers both mechanistic and empirical biosimulation solutions, providing clients with a comprehensive offering based on their therapy goals, mechanism of action, and available data sources. Mechanistic biosimulation models are built by experts using known scientific principles and facts, while empirical biosimulation solutions are typically statistical models built using preclinical and clinical data. Key products in this segment include the Simcyp Simulator, which is frequently utilized for determining first-in-human dosing, optimizing clinical study design, evaluating new drug formulations, setting the dose in untested populations, performing virtual bioequivalence analyses, and predicting drug-drug interactions (DDIs). The Simcyp Simulator family includes various add-on modules, as well as products focused on specific aspects of drug development that can benefit from its mechanistic simulation approach. Major Simcyp products include Simcyp Discovery, tailored for scientists working on pre-Investigational New Drug (IND) and translational stages, Simcyp Biopharmaceutics, tailored for formulation scientists, and Simcyp Secondary Intelligence, which integrates toxicology with quantitative analysis of large networks of molecular and functional biological changes to identify drug toxicity and adverse drug reactions earlier.

• Empirical Biosimulation Software Platform: In addition to mechanistic modeling, MIDD requires empirical statistical modeling to account for all the data available on a drug, including population variability. Certara provides customers with a powerful combination of scientific expertise, bringing experts with experience in thousands of projects across the industry, together with industry-standard software applications. The Phoenix PK/PD suite is the life sciences industry's premier software for managing, analyzing, and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Phoenix has four modules that support pharmacometrics and workflow, including Phoenix WinNonlin, a platform for non-compartmental analysis, PK/PD, and TK modeling with a regulatory-proven 30-year history and extensive use across the biopharmaceutics industry, Phoenix Cloud, the next-generation cloud version of Phoenix, which provides a secured and validated Certara Amazon Web Services (AWS) workspace allowing for much quicker transit time from compliant data sources, Phoenix NLME, a population modeling and simulation software for nonlinear mixed effects (NLME) models, and Pirana Modeling Workbench, a workbench providing modelers with a structure to facilitate the iterative processes used to create population PK/PD models and perform simulations using AI and machine learning resulting in more efficient model selection and analysis.

• Scientific Informatics for Improving Drug Discovery and In-Silico Development: In 2024, Certara acquired Chemaxon, a software company that develops leading software products for chemical property prediction, search, and analysis. Used by research scientists globally, Chemaxon software helps to digitize the design, make, test, and analyze discovery lifecycle to select the best new chemical leads. Certara and Chemaxon have had a long-term partnership spanning ten years, providing integrated solutions to the life sciences industry. The acquisition strategically positions Certara in the drug discovery biosimulation market and complements Certara’s existing biosimulation portfolio, which is widely used in later phases of drug development. Together, Certara and Chemaxon offer life sciences companies a more complete data and predictive analytics platform, helping to advance the decision-making from discovery through commercialization. Major Chemaxon and Certara products focused on supporting more efficient chemical-related information and workflows throughout drug discovery and development include Chemaxon JChem Engines, a widely used chemical search engine that integrates chemical intelligence into research informatics systems, Chemaxon Compound Registration, which supports a streamlined lead optimization process workflow by comparing the uniqueness of new small molecules against those already stored in a database, Chemaxon Design Hub, a compound design and tracking platform for drug discovery teams and their external collaborators that connects workflows for scientific hypotheses, candidate compound selection, and computational capabilities, Certara D360 Software, a scientific informatics application for small molecule and biologics discovery that provides researchers with industry-leading self-service data access, comprehensive data visualizations, analysis, and collaboration tools for prioritization, development of Structure Activity Relationship (SAR), and many other scientific data workflows to improve the effectiveness of data-driven research, and Chemaxon Marvin, a universal chemical drawing tool for chemists involved in research and drug discovery that includes chemical intelligence to catch errors and perform live calculations and predictions and has a wide range of built-in tools to create publication-worthy chemical schemes.

• Preclinical & Clinical Data Pipeline and Automation Suite: Certara's data suite allows customers to efficiently standardize preclinical and clinical data during the drug development process, utilize that data to support MIDD, and efficiently submit it to regulatory authorities for approval. The company's products allow pharmaceutical companies to reduce the cost of creating scientifically valid and analyzable data sets, speeding time to scientific insights and enabling better and faster decisions. The Certara suite of applications replaces costly manual processes in which pharmaceutical companies collect laboratory and clinical data from many sources, standardize, validate, analyze the data, and include it in reporting and downstream systems. The principal clinical data suite is the Pinnacle 21 family of products, which includes Pinnacle 21, a cloud-based application for clinical data collection, standardization, and validation with industry standards that is widely utilized across the pharmaceutical industry and by its regulators to validate that clinical data meets the required standards for regulatory submittal, Pinnacle 21 Data Exchange, which allows sponsors and data providers to define data standards and specifications (metadata) and ensure that collected clinical data adheres to these specifications to make the process of acquiring external data from laboratory and clinical sources more efficient and predictable, and Metadata Repository, a cloud-based Clinical Metadata Repository & Study Data Tabulation Model automation suite to enable faster transformation from protocol study design using controlled and standardized metadata and setting up the clinical study to produce faster time to analysis resulting in more successful clinical trials.

• Regulatory Science: Certara's comprehensive regulatory science solutions provide customers with the coordinated technology-enabled regulatory submission and regulatory writing expertise they need to accelerate the regulatory writing and filing process. Key products in this segment include CoAuthor Software, which combines data integration, structured content authoring, and generative AI to enable writers to create and assemble regulatory submissions and medical publications faster and with confidence in the quality of their results, and GlobalSubmit eCTD Submissions Management, which provides regulatory teams with the tools they need to efficiently review, validate, and publish eCTD submissions.

• Technology-Enabled Services: In addition to core software platforms, Certara's scientists utilize the company's software to offer a broad range of technology-enabled services to help clients interpret biosimulation results, increase scientific insights related to the therapy, streamline drug submission and approval, and support the overall drug development process. Key services include Quantitative Systems Pharmacology (QSP), which combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process, Drug Development and Regulatory Strategy, which involves scientific experts developing and delivering drug development and regulatory plans and providing high-level regulatory input to customer projects, incorporating biosimulation and supporting decision-making through critical development and investment stage gates, Pharmacometrics, which uses mathematical and statistical models to quantify drug, disease, and trial information to help address decisions, Data Science, which helps clients analyze and standardize data for faster time to insight and for submission readiness, in addition to preparing and transforming data for use in biosimulation and pharmacometrics models, Clinical Pharmacology, which provides early-phase development plans and study designs across the development life cycle, often incorporating biosimulation along with regulatory support, and Regulatory Science, which provides expert services for regulatory submissions from early-stage INDs, new drug applications, and MAAs that require Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical expertise.

Certara's position within the industry is strengthened by its comprehensive approach to biosimulation, combining scientific modeling expertise, regulatory experience, and technology enablement. The company competes with other technology companies including Mathworks, Dassault Systemes, Ansys, Simulations Plus, and NONMEM, a division of ICON. Other competitors include open-sourced solutions such as R and PK-Sim and internally developed software from biopharmaceutical companies. Certara's competitive advantages include the functionality and quality of its models, the breadth of molecular types, therapeutic areas, and modalities supported, regulator acceptance of its solutions, ease of use and functionality of applications, depth of experience in drug development, brand awareness and reputation, total cost, and the ability to securely integrate with other enterprise applications and the overall drug research and development process in the customer. The company's ability to remain competitive depends on its ability to continue to invest in innovation as MIDD and drug development science advances.

Certara's customers include life sciences companies of all sizes, along with contract research organizations, academic and government institutions, and global regulators. The company's science, technology, and consulting services have been used by more than 2,600 biopharmaceutical and biotech companies and academic institutions across 70 countries, including 38 of the top 40 biopharmaceutical companies by R&D spend in 2025. Certara also derives limited revenue from contracts with U.S. government agencies, including the FDA and the U.S. Department of Health and Human Services (DHHS), as well as some foreign governments. In addition to life sciences, Certara serves customers in animal health, crop science, bioscience, medical devices, and public sector industries. No single customer accounted for more than 10% of the company's revenues in 2025, and the ten largest customers accounted for 24% and 27% of revenues for the years ended December 31, 2025 and 2024, respectively.