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, Inc. (Nasdaq: SLP) has appointed Will Frederick as its new chief financial officer (CFO), succeeding John Kneisel who retires after seven years. Frederick brings over 25 years of experience in financial leadership, with a focus on revenue growth and corporate strategy. CEO Shawn O’Connor praised Frederick’s background, highlighting his previous experience in mergers and public company CFO roles. The company has a strong history under Kneisel, achieving consistent revenue growth and three successful acquisitions.
Simulations Plus reported a strong FY20 with revenues of $41.6 million, up 22.4% from FY19. Gross profit increased 24.0% to $30.9 million. Net income rose 8.7% to $9.3 million, boosting diluted EPS to $0.50. For 4QFY20, revenues climbed 18.9% to $9.5 million, with net income at $2.2 million. The company raised $107.7 million through a follow-on offering, enhancing resources for acquisitions. CEO Shawn O’Connor highlighted robust growth amidst the pandemic, driven by software and consulting services.
Simulations Plus (Nasdaq: SLP) announced that its DILIsym liver safety software contributed to public comments to the California Office of Environmental Health Hazard Assessment (OEHHA) regarding the carcinogenicity of acetaminophen (APAP). The Consumer Healthcare Products Association utilized DILIsym's simulations, which indicated that while high doses of APAP can pose acute liver toxicity, they do not lead to cancer. The FDA's comments supported these findings. DILIsym's modeling aids in drug development decisions, minimizing risks associated with drug-induced liver injury.
Simulations Plus, Inc. (Nasdaq: SLP) announced it will report its fourth quarter and full year financial results for fiscal year 2020 on November 16, 2020, after market close. The company will host a conference call at 4:15 p.m. ET on the same day, allowing interested parties to participate by registering online. Simulations Plus specializes in drug discovery and development software and consulting services, aiding pharmaceutical and biotechnology companies in the regulatory submission process.
Simulations Plus, a leader in simulation and modeling software for pharmaceutical development, announced that CEO Shawn O'Connor will present at the Credit Suisse 29th Annual Virtual Healthcare Conference on November 10, 2020, at 3:30 p.m. ET. His presentation will be available via a live webcast, and a slide presentation can be accessed on the company's Investors page afterwards. Simulations Plus provides advanced modeling solutions utilized by major pharmaceutical and regulatory agencies worldwide.
Simulations Plus (Nasdaq: SLP), through its subsidiary Lixoft, has announced the release of MonolixSuite version 2020R1, enhancing population PKPD modeling solutions. Key improvements include an upgraded Simulx module with a user-friendly GUI, new dataset filters, a tumor growth inhibition library, and advanced capabilities for non-compartmental analysis (NCA). These updates aim to streamline modeling and simulation processes in drug development. Lixoft emphasizes user experience and advanced statistical methods that align with industry demands.
DILIsym Services, a Simulations Plus company (Nasdaq: SLP), announced that its DILIsym® software was referenced in the FDA's review of the New Drug Application for Pexidartinib (Turalio®), marking a milestone as the first systemic therapy for tenosynovial giant cell tumor. The FDA noted DILIsym's utility in assessing hepatocellular injury and its impact on safety predictions in drug development. The software aids in identifying drug-induced liver injury risks, potentially influencing regulatory decisions and benefiting patient safety.
Simulations Plus, Inc. (Nasdaq: SLP) has announced the launch of version 9.8 of its leading modeling and simulation platform, GastroPlus®. This update features key enhancements such as the industry's first mechanistic model for intra-articular delivery and a revamped bioequivalence trial simulation engine, aligning with new FDA guidelines. The company emphasizes its commitment to improving drug development efficiency, as highlighted by collaborations with various industry partners. These improvements are aimed at enhancing clinical pharmacology capabilities and drug-drug interaction simulations.
Simulations Plus (Nasdaq: SLP) has declared a quarterly cash dividend of $0.06 per share, set for distribution on November 2, 2020. Shareholders of record by October 26, 2020 will receive this dividend, continuing the board's commitment to regular quarterly dividends. The board will evaluate future dividends based on the company's earnings, financial condition, and capital requirements. Simulations Plus specializes in modeling and simulation solutions for the pharmaceutical and biotechnology sectors.
Simulations Plus, Inc. (Nasdaq: SLP) has received a new FDA cooperative agreement to develop in vitro/in silico models for oral drug administration. This partnership with St. Louis College of Pharmacy aims to enhance pharmaceutical research for innovative and generic products. Using the Dynamic In Vitro Dissolution and Absorption Model, the project will improve the characterization of oral formulations. FDA staff will collaborate on the research, continuing a series of funded collaborations that bolster the company's reputation in modeling and simulation solutions for the pharmaceutical industry.