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Simulations Plus, Inc. (NASDAQ: SLP) is a leading developer of modeling and simulation software and consulting services that support drug discovery, development research, and regulatory submissions. The company collaborates with pharmaceutical organizations to implement a data-driven, strategic modeling methodology that begins in early discovery stages, extends through preclinical and clinical development, and continues into clinical trials and post-approval phases.
Simulations Plus, through its subsidiaries Cognigen Corporation and DILIsym Services, offers a suite of top-ranked, user-friendly software solutions. These include GastroPlus™, ADMET Predictor™, KIWI™, DILIsym®, NAFLDsym®, PKPlus™, and more. These tools bridge data mining and compound library screening with QSAR models and PBPK/TK modeling and simulation in both animals and humans. The company's quantitative systems pharmacology approaches are widely recognized and licensed by regulatory agencies globally.
In addition to software development, Simulations Plus provides consulting and contract research services to the pharmaceutical industry. The company’s operations are divided into two primary segments: software and services. The software segment generates the majority of the company’s revenue.
Over the past 20 years, Simulations Plus has consistently partnered with clients to reduce costs and accelerate research timelines. The company’s innovative technology and methodologies have earned it a reputation as a reliable partner in the pharmaceutical industry.
Latest News: Simulations Plus continues to make headlines with its innovative solutions and strategic partnerships. Stay updated with the latest developments and achievements of Simulations Plus on our news section.
Simulations Plus, Inc. (NASDAQ: SLP) announced the completion of a project funded by the U.S. FDA and the Center for Research on Complex Generics. The collaboration, involving the Lixoft and Cognigen divisions, aims to demonstrate bioequivalence for long-acting injectables (LAI) using a novel model-integrated design. This method could alleviate the challenges of low power and prolonged duration in bioequivalence trials. The results were presented at an FDA workshop on Nov. 30, 2021.
Simulations Plus (Nasdaq: SLP) has announced a funded partnership with a major pharmaceutical company to enhance mechanistic dissolution models for injectable formulations using their DDDPlus™ software. This collaboration aims to improve in vitro analysis of drug product specifications and capture dissolution kinetics more effectively. Senior scientists expressed enthusiasm about expanding market opportunities in injectables, while the company retains ownership of all software improvements. Simulations Plus continues to support global pharmaceutical development through innovative biosimulation solutions.
Simulations Plus, a leader in modeling and simulation software for pharmaceutical safety, announced participation in the Berenberg Discover AI Seminar on April 26, 2022, in Boston, Massachusetts. CEO Shawn O’Connor will hold one-on-one meetings during the event. For details on the seminar, the slide presentation will be accessible on the Simulations Plus Investors page. With 25 years of experience, Simulations Plus supports drug discovery and regulatory submissions through advanced software solutions licensed by major pharmaceutical companies and regulatory agencies worldwide.
Simulations Plus, Inc. (Nasdaq: SLP) reported a 13% increase in total revenue for Q2 FY2022, reaching $14.8 million. Software revenue grew by 25% to $9.8 million, now comprising 66% of total revenue. The company’s diluted EPS rose 40% to $0.21, with net income at $4.4 million.
Despite a 5% decline in services revenue, strong performance in the software sector, particularly MonolixSuite®, which saw 43% growth, boosted overall results. The Board declared a quarterly dividend of $0.06 per share.
Simulations Plus (SLP) has announced a partnership with the University of Pittsburgh to develop and validate its BIOLOGXsym™ platform, focused on quantitative systems toxicology for liver safety. A Phase II SBIR NIH grant of approximately $1.7 million will fund software development and lab work over two years. The collaboration aims to enhance drug safety assessments, particularly for large molecules, and will utilize the university's advanced organ-on-a-chip technology for testing. This initiative is seen as a pivotal step in expanding SLP's offerings in the growing therapeutic development market.
Simulations Plus (NASDAQ: SLP) announced record attendance for the 2022 MIDD+ Scientific Conference held on February 16-17, attracting participants from 57 countries. The event focused on advancing model-informed drug development with sessions covering all drug development stages. Keynote speaker Rajanikanth Madabushi from the FDA emphasized a holistic approach. Presentations included regulatory perspectives from global agencies. The conference highlights the company's leadership in biosimulation and its role in the pharmaceutical industry.
Simulations Plus (NASDAQ: SLP) announced it will report its financial results for the second quarter of fiscal year 2022 on April 6, 2022, after market close. The announcement includes a conference call scheduled for 5:00 PM ET on the same day, where stakeholders can join via registration link or phone. The company provides advanced biosimulation software and consulting services for drug discovery, and has been in operation for 25 years, serving clients globally.
Simulations Plus (NASDAQ: SLP) has launched MembranePlus™ 3.0, enhancing in vitro-in vivo extrapolation (IVIVE) for transdermal product analysis. Key features include new models for in vitro penetration and release tests, expanded membrane transport parameters, and improved simulation performance. The update aims to provide insights for formulation strategies, reducing the need for animal testing. Senior Scientist Dr. Jessica Spires noted the product's integration with GastroPlus® to benefit researchers in predicting topical administration outcomes.
Simulations Plus (Nasdaq: SLP) announced its participation in Oppenheimer’s 32nd Annual Healthcare Conference, occurring virtually on March 15-16, 2022. CEO Shawn O’Connor will present on March 15 at 4:00 p.m. ET and will also host one-on-one meetings. Interested parties can access the live event or request meetings via their Oppenheimer representatives. The presentation slides will be available afterwards on the company’s Investors page.
Simulations Plus, serving clients for 25 years, specializes in modeling and simulation software for pharmaceutical development and research.
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