Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus, Inc. (Nasdaq: SLP) has entered a new funded collaboration with a major pharmaceutical company to enhance machine learning models and physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) approaches for treating pulmonary infections. Significant investments from the partner are set to make Simulations Plus' technology a key component of their research strategy. The collaboration will utilize the ADMET Predictor® and GastroPlus® platforms to inform drug discovery and development, focusing on specific populations for greater regulatory acceptance.

Simulations Plus, Inc. (Nasdaq: SLP) reported a 14% revenue increase to $10.7 million for Q1 FY2021, with gross profit rising 22% to $8.3 million. Gross margin improved to 77% from 72%, and net income increased 21% to $2.5 million. Diluted earnings per share reached $0.12, up 9%. CEO Shawn O’Connor noted strong double-digit growth despite tough comparisons to FY2020. Key factors include strategic investments and the Lixoft acquisition, which expanded market reach. The company forecasts an organic growth of 15% to 20% for the fiscal year, alongside a declared dividend of $0.06 per share.

Simulations Plus (Nasdaq: SLP) has announced a new collaboration with a major pharmaceutical company to enhance its GastroPlus® Advanced Compartmental Absorption and Transit (ACAT™) model for oral peptide formulations. The project aims to improve intestinal absorption simulations for larger molecules, utilizing unique data from the partner. This partnership aligns with the growing demand for oral therapeutic peptides, expanding the company's modeling capabilities. All enhancements will be available to SLP’s user community, aiming to accelerate drug development timelines.

Simulations Plus, Inc. (Nasdaq: SLP) will report its financial results for the first quarter of fiscal year 2021 after the market closes on January 11, 2021. A conference call will follow at 4:15 p.m. Eastern Time, inviting all interested parties to join by registering online or via phone. The call will also be available as a live webcast. Simulations Plus specializes in modeling and simulation software for drug discovery and development, with its technology used by several major pharmaceutical and biotechnology companies worldwide.

DILIsym Services, a subsidiary of Simulations Plus (Nasdaq: SLP), presented key research at the 2020 AASLD virtual Liver Meeting, showcasing their modeling software applications for drug safety and efficacy. Notable studies included the liver safety profile of remdesivir and the role of adiponectin in treating non-alcoholic fatty liver diseases, utilizing DILIsym and NAFLDsym software. These presentations emphasize the company’s commitment to advancing pharmaceutical collaborations and improving drug development processes.

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.