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) reported Q1 FY2026 results for the quarter ended Nov 30, 2025: total revenue $18.4M (down 3% YoY), software revenue $8.9M (down 17%), services revenue $9.5M (up 16%). Gross profit was $10.9M with gross margin 59% (versus 54% prior year). GAAP net income was $0.7M (diluted EPS $0.03); adjusted net income was $2.6M (adjusted diluted EPS $0.13). Adjusted EBITDA was $3.5M (19% of revenue). The company reaffirmed FY2026 guidance: revenue $79M–$82M, software mix 57–62%, adjusted diluted EPS $1.03–$1.10, and adjusted EBITDA margin 26–30%. A virtual Investor Day is scheduled for Jan 21, 2026.
Simulations Plus (Nasdaq: SLP) will host a virtual Investor Day on January 21, 2026 to outline its long-term strategy for model-informed drug development (MIDD).
The 90-minute webcast (1:00 PM–2:30 PM ET) will cover the company’s unified product and technology strategy, advances in scientific services across the drug lifecycle, the industry environment and accelerating adoption of MIDD, and the company’s financial priorities and outlook, followed by a leadership Q&A. A replay will be posted after the event.
Simulations Plus (NASDAQ: SLP) will report first quarter fiscal 2026 results after market close on Thursday, January 8, 2026. Management will host a conference call the same day at 5:00 p.m. Eastern Time to discuss the results.
Investors can join via live webcast (registration required), dial 1-877-451-6152 (U.S.) or 201-389-0879 (international), or request a return call via Call me™. A replay will be available on the company investor relations page approximately one hour after the call.
Simulations Plus (Nasdaq: SLP) on December 9, 2025 positioned its validated modeling engines and AI-orchestrated ecosystem to respond to the FDA's draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The company highlights integration of PBPK (GastroPlus), QST/QSP (BIOLOGXsym), and population modeling (MonolixSuite) to support weight-of-evidence assessments and reduced animal testing.
Simulations Plus plans continued biologics modeling enhancements and frames its tools as aligned with FDA emphasis on mechanistic, model-informed nonclinical decision-making.
Simulations Plus (NASDAQ: SLP) reported fiscal 2025 results and reaffirmed fiscal 2026 guidance. FY2025 total revenue was $79.2M (+13% vs prior year) with software revenue $45.8M (58% mix) and services $33.4M (42% mix). Adjusted EBITDA was $22.0M (28% margin) and adjusted diluted EPS was $1.03. The company recorded a $77.2M non-cash impairment, producing a GAAP net loss of $64.7M and diluted loss per share of $3.22 for FY2025. Q4 revenue was $17.5M (-6% YoY) with software down 9% to $9.0M. Management reaffirmed FY2026 guidance of $79–$82M revenue and adjusted diluted EPS $1.03–$1.10 and announced a Virtual Investor Day on Jan 21, 2026 to present its AI product vision.
Simulations Plus (Nasdaq: SLP) provided preliminary fiscal 2025 results and issued fiscal 2026 guidance on October 22, 2025. Key preliminary fiscal 2025 metrics include $79.1M revenue, 13% revenue growth, 58% software mix, 28% adjusted EBITDA margin, and $1.03 adjusted diluted EPS. For fiscal 2026 management issued preliminary guidance of $79M–$82M revenue, 0–4% revenue growth, 57–62% software mix, 26–30% adjusted EBITDA margin, and $1.03–$1.10 adjusted diluted EPS. Results are preliminary and unaudited; final audited results and a full fiscal 2025 report will be filed on Form 10-K and released on December 1, 2025.
Management cited challenging market conditions and outlined a multi‑year Cloud and AI product vision, noting the launch of GastroPlus X.2 on S+ Cloud and planned expansion of AI capabilities.
Simulations Plus (NASDAQ:SLP), a leading provider of cheminformatics and biosimulation solutions for the biopharma industry, has announced its participation in two major investor conferences in September 2025.
CEO Shawn O'Connor will attend the 2025 Wells Fargo Healthcare Conference in Boston on September 3-4, featuring a fireside chat on September 3 at 12:45 PM ET. Additionally, he will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York City on September 10, with a fireside chat scheduled for 2:35 PM ET.
Simulations Plus (Nasdaq: SLP) and the Institute of Medical Biology of the Polish Academy of Sciences (IMB PAS) have published successful results of their artificial intelligence-driven drug design (AIDD) collaboration in ACS Medical Chemistry Letters. The partnership, initiated in 2023, focused on designing novel RORγ/RORγT ligands using ADMET Predictor®.
The results showed that 70% of the 27 tested compounds demonstrated significant RORγT inhibition. The lead compound, featuring a novel indolizine scaffold, showed potent inverse agonist activity, strong efficacy in cellular assays, no significant cytotoxicity, and effectively suppressed proinflammatory Th17 cytokines in human T cells. The compound also displayed favorable drug-like properties as predicted by ADMET Predictor.
Simulations Plus (Nasdaq: SLP) has announced a $1 million investment in Nurocor, a cloud-based software platform provider for clinical development. The investment, made through SLP's Corporate Development Initiative launched in 2024, aims to accelerate innovations in biopharma development.
Nurocor's technology, founded in 2017, focuses on improving efficiency and automation in clinical trials through digitalization. The clinical trial technology sector, valued at $25.7 billion in 2024, is expected to grow at a CAGR of 15.5% from 2025 to 2030. This strategic investment aligns with SLP's mission to expedite drug development and enhance clinical trial processes.
Simulations Plus (Nasdaq: SLP), a provider of biosimulation and cheminformatics solutions, reported Q3 fiscal 2025 results with total revenue increasing 10% to $20.4 million. The quarter saw software revenue grow 6% to $12.6 million and services revenue rise 17% to $7.7 million.
The company recorded a net loss of $67.3 million ($3.35 per share) due to a one-time non-cash impairment charge of $77.2 million. Adjusted EBITDA reached $7.4 million, representing 37% of total revenue. The company implemented a strategic reorganization, transitioning to a functionally-driven operating model.
Management updated FY2025 guidance with revenue expected between $76-80 million and adjusted diluted EPS of $0.93-$1.06. The company is focusing on new AI-driven initiatives across product lines to drive innovation and growth.
[ "Total revenue increased 10% to $20.4 million in Q3 2025", "Services revenue grew 17% to $7.7 million", "Software revenue increased 6% to $12.6 million", "Adjusted EBITDA improved to $7.4 million (37% of revenue) from $5.6 million", "Adjusted diluted EPS increased to $0.45 from $0.27 year-over-year", "Implementation of new AI-driven initiatives across product lines" ]