Welcome to our dedicated page for Simulations Plus news (Ticker: SLP), a resource for investors and traders seeking the latest updates and insights on Simulations Plus stock.
Simulations Plus, Inc. provides model-informed and AI-accelerated drug development software, training, and consulting services for biopharmaceutical research. News about the company centers on its software and services segments, scientific modeling engines, ADMET and other modeling workflows, and financial results tied to software renewals, services bookings, and customer activity.
Recurring developments also include collaborations with pharmaceutical companies, technology providers, and regulatory or public-health agencies. These updates cover GPU-accelerated simulation, AI-assisted modeling, predictive frameworks for complex oral drug products, computational toxicology, new approach methodologies, and education programs that expand use of model-informed drug development practices.
Simulations Plus (Nasdaq: SLP) has launched the beta version of its DILIsym® version X (DSX), a significant update to its quantitative systems toxicology software aimed at predicting drug-induced liver injury (DILI). This new version enhances speed and user-friendliness, supporting wider adoption among pharmaceutical companies, regulators, and academics. Key updates include a software redesign, new exemplar compounds, and improved biomarker parameters. The DILIsym modeling approach is crucial for guiding drug development decisions and avoiding costly clinical trial failures.
Simulations Plus (NASDAQ: SLP) has initiated an accelerated share repurchase (ASR) program to buy back $20 million of its common shares, part of a larger $50 million share repurchase plan approved in December 2022. This move is aimed at enhancing shareholder value and aligns with the company's updated capital allocation strategy. Funding for the ASR will come from available cash balances, and the final settlement is expected by Q3 2023. Post-ASR, $30 million will remain for additional repurchases.
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.
Summary not available.
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.