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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), a provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, has scheduled its second quarter fiscal 2025 earnings release and conference call.
The company will announce its Q2 FY2025 financial results after market close on Thursday, April 3, 2025, followed by a management-hosted conference call at 5:00 p.m. Eastern Time. Investors and shareholders can join the webcast through registration or dial in using 1-877-451-6152 (domestic) or 201-389-0879 (international).
Simulations Plus (Nasdaq: SLP), a leader in cheminformatics, biosimulation, and medical communications for the biopharma industry, has announced its participation in the KeyBanc Capital Markets Virtual Healthcare Investor Forum.
CEO Shawn O'Connor will engage in a fireside chat on Tuesday, March 18, 2025, at 2:15 p.m. Eastern Time. The event will include one-on-one meetings with institutional investors throughout the day. Interested parties can access the fireside chat through a live webcast, which will be available on the Simulations Plus website's Investors page for approximately 90 days after the event.
Simulations Plus (Nasdaq: SLP), a leading provider of cheminformatics, biosimulation, and medical communications solutions to the biopharma industry, has announced its participation in two major healthcare investor conferences in February 2025.
The company will attend the BTIG 12th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah, where CEO Shawn O'Connor will conduct one-on-one meetings with institutional investors on February 11, 2025.
Additionally, SLP will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference, held virtually on February 12, 2025. O'Connor will lead a fireside chat at 12:40 PM ET and host one-on-one investor meetings. The fireside chat will be available via webcast and accessible through the Simulations Plus website's Investors page, with replay options available post-event.
Simulations Plus (Nasdaq: SLP) has announced a strategic collaboration with the Enabling Technologies Consortium (ETC) to enhance its GastroPlus platform. The funded partnership aims to advance in vitro-in vivo correlation approaches for oral drug delivery by improving the GastroPlus advanced compartmental absorption and transit (ACAT™) model.
The collaboration will focus on developing immediate release oral drug products through enhanced predictive capabilities. Key developments include implementing novel product-particle size distribution methodologies and improved food effect modeling features. These advancements aim to improve drug product development, reduce animal studies, and streamline regulatory submissions.
Throughout the project, Simulations Plus will provide ETC members with beta versions for testing. The final enhanced software will be available to all users, with Simulations Plus retaining intellectual property rights from the partnership.
Simulations Plus (Nasdaq: SLP) announced that its technology and expertise supported the development of 100% of FDA-approved drugs in 2024. The company provides cheminformatics, biosimulation, and medical communications solutions to the biopharma industry.
The company's suite of solutions incorporates artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD modeling approaches. These technologies, combined with adaptive learning and medical communications tools, help accelerate drug development processes and support critical advancements in global healthcare.
Simulations Plus (Nasdaq: SLP) announced its significant impact on pharmaceutical development, revealing that its technology supported the majority of FDA-approved drugs in 2024. The company's comprehensive suite of solutions includes artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), and quantitative systems pharmacology/toxicology (QSP/QST) modeling approaches.
CEO Shawn O'Connor emphasized the company's 25-year track record in providing mission-critical software and services for therapy development. SLP's offerings encompass drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization support, demonstrating their integral role in advancing global healthcare solutions.
Simulations Plus (Nasdaq: SLP) reported strong Q1 fiscal 2025 results with total revenue increasing 31% year-over-year to $18.9 million. The growth was primarily driven by software revenue, which rose 41% to $10.7 million (57% of total revenue), while services revenue grew 19% to $8.2 million (43% of total revenue).
Key financial metrics include gross profit of $10.2 million (54% margin), net income of $0.2 million, and diluted EPS of $0.01, compared to $1.9 million and $0.10 in Q1 2024. Adjusted EBITDA reached $4.5 million (24% of revenue). The MonolixSuite™ platform showed strong performance with 43% growth, and the QSP business unit grew 40%. The company maintained its fiscal 2025 guidance of $90-93M in revenue (28-33% growth) with adjusted EBITDA margin of 31-33%.
Simulations Plus (Nasdaq: SLP), a provider of biosimulation and medical communications solutions for the biopharma industry, has scheduled its first quarter fiscal 2025 earnings release and conference call for Tuesday, January 7, 2025. The financial results will be announced after market close, followed by a management-hosted conference call at 5:00 p.m. Eastern Time.
Investors and shareholders can join the live webcast through registration or dial in using 1-877-451-6152 (domestic) or 1-201-389-0879 (international). A replay will be available on the company's investor relations website approximately one hour after the call.
Simulations Plus (Nasdaq: SLP), a leading biosimulation and medical communications solutions provider, announces its participation in the upcoming BTIG Digital Health Forum on November 25, 2024. CEO Shawn O'Connor will join a panel discussion on 'Supporting Drug Development, Clinical Trials, and Biopharma' at 2:00 p.m. Eastern Time and conduct one-on-one meetings throughout the day. Interested participants must pre-register through the BTIG website to attend the virtual event.
Simulations Plus (Nasdaq: SLP) and the University of Connecticut have received a new FDA grant to expand mechanistic modeling for long-acting injectable (LAI) technologies. The collaboration will use GastroPlus® PBPK platform to investigate relationships between LAI formulation and physiological factors at injection sites. The project aims to develop models that could serve as alternatives to in vivo studies for establishing bioequivalence. Dr. Diane Burgess's lab will generate vital data for marketed LAI suspension products, while Simulations Plus will develop PBPK models for validation. The initiative seeks to reduce development time and costs while streamlining regulatory processes for both innovator and generic formulations.