Simulations Plus

Predicting DILI risk supports informed decision-making regarding drug evaluations and approvals

Total revenue of $18.3 million and diluted earnings per share (EPS) of $0.20

Simulations Plus to Present at the KeyBanc Capital Markets Virtual Life Sciences & MedTech Investor Forum

Partnership will produce an enhanced, validated dermal PBBM/PBPK model to inform product development and bioequivalence decisions.

Research project with NIEHS includes focus on qualification of in silico methods for prioritization, assessment of risk, and identification of safety margins for chemical use.

Strategic investments in early-stage companies to drive innovation and collaboration

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it will participate in two healthcare conferences in February.

New version delivers on FDA collaborations and user feedback for expansion of non-oral delivery route models

Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product development

Amparo de la Peña, Vice President of Pharmacometrics at Simulations Plus, will join Jeff Sachs, Pavan Vaddady and Hao Zhu as new board members for 2024.

Fiscal 2023 revenue increased 11% year-over-year to $59.6 million
Provides Fiscal 2024 revenue guidance of $66 - $69 million (+10-15%) and EPS guidance of $0.66 - $0.68
Simulations Plus to host its Investor Day on November 14, 2023

Collaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual bioequivalence studies

Immersive activities helped attendees globally learn and apply best practices for PBPK modeling

Dr. Lukacova’s outstanding contributions to pharmaceutical research and innovation to be recognized with seven others at AAPS PharmSci 360

Elevated ALT levels during clinical trials led researchers to use quantitative systems toxicology (QST) software to better understand potential underlying mechanisms

New functionality, models, and partner data power predictive accuracy from the industry-leading machine learning platform

Total revenue of $16.2 million and diluted earnings per share (EPS) of $0.20
Maintains full-year revenue guidance of $59.3 - $62.0 million (+10-15%) and EPS guidance of $0.63 - $0.67

Acquisition increases breadth and depth of QSP expertise and range of therapeutic applications

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of a new integrated pulmonary software and services package.

Provides FDA with software tools to investigate drug-induced liver injury in clinical trials