Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus reported Q1 fiscal 2023 total revenue of $12 million, consistent with guidance, and diluted EPS of $0.06. Software revenue decreased 17% to $6.1 million, while services revenue increased 17% to $5.9 million. The company announced a $50 million share repurchase program and continues to invest in its workforce. Fiscal 2023 guidance projects revenue growth of 10-15% and diluted EPS growth of 5-10%. A cash dividend of $0.06 per share was declared for February 6, 2023.

Simulations Plus (NASDAQ: SLP) will announce its first-quarter fiscal 2023 financial results, covering the period ended November 30, 2022, after market close on January 4, 2023. The company will host a conference call at 5 p.m. EST to discuss these results. Interested participants can register via the company's website. Simulations Plus has provided biosimulation solutions for over 25 years, supporting drug discovery and regulatory submissions across major pharmaceutical and biotech sectors.

Simulations Plus has been awarded a grant by the U.S. FDA to develop a modeling framework aimed at assessing bioequivalence for locally-acting drugs targeting the gastrointestinal tract. This collaboration with the University of Bath will enhance the GastroPlus® platform, aiming to reduce reliance on animal and human studies. The project focuses on generating in vitro data for various GI conditions, potentially providing innovative solutions for drug development and regulatory processes.

Simulations Plus has announced the appointment of Gustavo Mendes Lima Santos to its Regulatory Affairs team for a one-year fellowship. He will collaborate with global health regulatory agencies and academia to enhance pharmacometric strategies. Santos, who previously served as General Manager at Anvisa, brings extensive expertise in drug evaluation and regulatory processes. His work is expected to boost drug development programs, particularly in Latin America, by leveraging modeling and simulation techniques.

Simulations Plus, Inc. (NASDAQ: SLP) announced a funded contract with the FDA to advance in vitro and physiology-based pharmacokinetics (PBPK) models for inhaled drug development. This collaboration aims to enhance the Pulmonary Compartmental Absorption and Transit (PCAT™) model, using data from healthy and patient samples to validate and propose alternatives for bioequivalence studies. The project is a continuation of Simulations Plus's commitment to improving drug development processes while minimizing the need for human and animal studies.

Simulations Plus, a leader in pharmaceutical modeling software, reported a 16% revenue increase year-over-year to $53.9 million for FY 2022. Diluted earnings per share rose 28% to $0.60. Q4 revenue surged 19% to $11.7 million, driven by a 30% increase in services revenue, while gross margin improved to 77%. For FY 2023, the company projects a revenue between $59.3 million and $62.0 million, signaling expected growth of 10% to 15%.

Simulations Plus (NASDAQ: SLP) has declared a quarterly cash dividend of $0.06 per share, scheduled for payment on November 7, 2022. Shareholders of record as of October 31, 2022 will receive this dividend. The decision for future dividends will be made quarterly by the Board based on earnings, financial situation, capital needs, and other considerations.

Simulations Plus has been a leader in the biosimulation market for over 25 years, providing essential software and consulting services to support drug discovery and development.

Simulations Plus (NASDAQ: SLP) has announced the launch of version 9.8.3 of its GastroPlus software, enhancing its physiologically based biopharmaceutics modeling capabilities. Key updates include improved reporting templates for Monolix, new validated disease populations for NAFL and NASH, a swine PBPK model for veterinary research, and flexible dosing regimen handling. The company aims to strengthen software interoperability and provide researchers with advanced simulation tools. This release reflects the company's ongoing commitment to integrating machine learning and quantitative systems pharmacology in drug development.