Simulations Plus sells biosimulation software and scientific consulting services to biopharma companies to help them develop drugs faster and at lower cost. The core use case is model-informed drug development — using computer models to predict how drug candidates behave in the body, reducing the need for lab experiments and animal tests. The company's flagship software products include GastroPlus, a physiologically based pharmacokinetics platform widely used in FDA and EMA regulatory submissions; ADMET Predictor, an AI/ML tool that predicts over 175 chemical and biological properties of drug candidates from molecular structure alone; MonolixSuite, a population PK/PD modeling platform competing with the legacy standard NONMEM; and a suite of quantitative systems toxicology platforms, including DILIsym, which predicts drug-induced organ injury. On the services side, Simulations Plus employs scientists who perform PBPK, QSP, and PK/PD consulting for clients lacking internal capacity. Software (~58% of revenue) is sold as annual licenses with ~79% gross margins, while services (~42% of revenue) are project-based with ~30% gross margins. The company counts ~311 commercial clients, primarily large pharma and biotech. In 2024, Simulations Plus acquired Pro-ficiency, adding simulation-based clinical trial training software and medical communications consulting. The company's growth strategy centers on integrating its platforms into a unified AI-assisted cloud ecosystem, cross-selling across the drug development lifecycle, and pursuing further M&A.
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