Simulations Plus (SLP) Company Report

Simulations Plus (SLP) is positioned to capitalize on the FDA's draft guidance for streamlined nonclinical safety studies for monospecific monoclonal antibodies.
The FDA's guidance encourages reduced reliance on animal studies and emphasizes mechanistic understanding, pharmacokinetics, and integrated weight-of-evidence (WoE) assessments.
The company's validated scientific engines (e.g., GastroPlus®, MonolixSuite®, BIOLOGXsym™) and AI-orchestrated framework align with this emerging regulatory framework.
CEO Shawn O’Connor views this regulatory shift as a new growth frontier for Simulations Plus, as model-informed safety and toxicology become essential disciplines.

Dec 9, 2025, 12:55 PM

Press Release

Simulations Plus Reports Fiscal Year 2025 Results and Provides 2026 Guidance

SLP

Earnings

Guidance Update

New Projects/Investments

Simulations Plus (SLP) closed fiscal year 2025 with 13% revenue growth, 8% adjusted EBITDA growth, and 8% adjusted EPS growth, achieving $79.2 million in total revenue and $1.03 adjusted diluted EPS.
For Q4 2025, total revenue decreased 6% to $17.5 million, with software revenue down 9% and services revenue down 3%. The company reported a net loss of $64.7 million and diluted loss per share of $3.22 for FY 2025, primarily due to a $77.2 million non-cash impairment charge.
The company provided fiscal year 2026 guidance, projecting total revenue between $79 million and $82 million (0%-4% year-over-year growth), adjusted EBITDA margin between 26%-30%, and adjusted diluted EPS between $1.03 and $1.10.
Simulations Plus completed its transition to a unified operating model and is focusing on an integrated product ecosystem that combines validated science, cloud-scale performance, and AI-driven services.

Dec 1, 2025, 10:00 PM

Transcript

Simulations Plus Reports Q4 and Full-Year 2025 Results, Provides 2026 Guidance

SLP

Earnings

Guidance Update

Demand Weakening

Simulations Plus (SLP) concluded fiscal year 2025 with $79.2 million in total revenue, marking a 13% increase, and achieved $1.03 in adjusted diluted EPS, an 8% increase. However, Q4 2025 saw a 6% decrease in total revenue to $17.5 million.
For fiscal year 2026, the company forecasts total revenue between $79 million and $82 million, representing 0%-4% year-over-year growth, and adjusted diluted EPS in the range of $1.03 to $1.10.
The company completed a transition to a unified operating model in fiscal 2025 and is advancing an integrated product ecosystem incorporating validated science, cloud capabilities, and AI, with portfolio-wide updates planned for fiscal 2026.
Despite a challenging external environment in 2025, management noted early signs of stabilization for calendar 2026, including improved biotech funding and clearer large pharma visibility, though near-term uncertainty is anticipated.
Software renewal rates were 83% for Q4 2025 and 88% for the full fiscal year, influenced by market conditions, client consolidations, and increased scrutiny on module configurations.

Dec 1, 2025, 10:00 PM

Transcript

Simulations Plus Reports Fiscal Year 2025 Results and Outlines Integrated Product Strategy

SLP

Earnings

Guidance Update

New Projects/Investments

Simulations Plus closed fiscal year 2025 with 13% revenue growth, 8% adjusted EBITDA growth, and 8% adjusted EPS growth, meeting its full-year guidance. However, Q4 2025 total revenue decreased 6% to $17.5 million, with software revenue down 9% and services revenue down 3%.
The company completed its transition to a unified operating model in 2025 and is focusing on building an integrated product ecosystem that leverages validated science, cloud-scale performance, and AI. More details on this strategy and roadmap will be shared at a virtual investor day in January.
Despite a challenging external environment in 2025, Simulations Plus is observing early signs of stabilization in the market for 2026, with improved biotech funding and clearer pricing visibility for large pharma, contributing to a cautious but positive outlook for budgeting activity.
The company's ending backlog increased 28% to $18 million, with at least 90% expected to convert to revenue within the next 12 months. Simulations Plus plans for more aggressive pricing in 2026, particularly for software incorporating new AI and cloud capabilities.

Dec 1, 2025, 10:00 PM

Transcript

SLP Reports Q4 and Full Year 2025 Results, Issues FY 2026 Guidance

SLP

Earnings

Guidance Update

Demand Weakening

For Q4 2025, SLP reported revenue of $17.5 million, a 6% decline year-over-year, and Adjusted Diluted EPS of $0.10.
For the full fiscal year 2025, revenue grew 13% to $79.2 million. Diluted EPS was ($3.22), primarily due to a $77.2 million non-cash impairment charge, while Adjusted Diluted EPS reached $1.03.
SLP issued fiscal year 2026 guidance, forecasting total revenue between $79 million and $82 million (representing 0% to 4% growth) and Adjusted Diluted EPS between $1.03 and $1.10.

Dec 1, 2025, 10:00 PM

Presentation

Simulations Plus Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Reaffirms 2026 Guidance

SLP

Earnings

Guidance Update

Demand Weakening

For the fourth quarter of fiscal 2025, Simulations Plus reported a 6% decrease in total revenue to $17.5 million, a net loss of $0.7 million, and adjusted diluted EPS of $0.10.
For the full fiscal year 2025, total revenue increased 13% to $79.2 million, while the company reported a net loss of $64.7 million and diluted loss per share of $3.22, which included a non-cash impairment charge of $77.2 million. Adjusted diluted EPS for the full year was $1.03.
The company reaffirmed its fiscal 2026 revenue guidance in the range of $79 million to $82 million and adjusted diluted EPS guidance of $1.03 to $1.10.
Management noted a cautious demand environment but believes the company is well-positioned to capture upside if the spending environment improves for its clients.

Dec 1, 2025, 9:06 PM

8-K

HelixAI Launches New Agentic Operating System for Life Sciences R&D

SLP

Product Launch

New Projects/Investments

HelixAI launched its first-in-class agentic operating system on November 18, 2025, at the AI Driven Drug Discovery Summit, aiming to transform life science R&D by enabling scientists to move from copilot to autopilot.
The platform unifies diverse in silico and wet lab research, offering enterprise-grade security, data traceability, and compliance to streamline complex R&D processes and accelerate drug discovery.
HelixAI has formed strategic partnerships with NVIDIA, AWS, and Sapio Sciences, alongside over 100 in silico tool providers such as Simulations Plus, CCDC, and Optibrium, ensuring access to a broad range of leading agentic tools.

Nov 18, 2025, 7:00 AM

Press Release

Simulations Plus Announces Preliminary Fiscal Year 2025 Results and Fiscal Year 2026 Guidance

SLP

Earnings

Guidance Update

Product Launch

Simulations Plus, Inc. (SLP) announced preliminary fiscal year 2025 results, reporting revenue of $79.1 million and adjusted diluted EPS of $1.03.
The company provided fiscal year 2026 guidance, projecting revenue between $79 million and $82 million and adjusted diluted EPS between $1.03 and $1.10.
Management expects to meet its revised fiscal 2025 guidance despite a challenging market and plans to expand AI capabilities, highlighted by the recent launch of GastroPlus® X.2 (GPX.2) with AI-powered tools.

Oct 22, 2025, 11:51 AM

8-K

Simulations Plus Discusses FY 2025 Performance and Growth Drivers

SLP

Guidance Update

Demand Weakening

New Projects/Investments

Simulations Plus experienced a material project cancellation and reduced bookings in Q3 FY25, leading to a guidance adjustment, primarily impacting its consulting services due to client budget constraints and new industry challenges.
The company's software licensing business, which constitutes 60% of its revenue, remains relatively stable with 90%+ renewal rates, as clients continue to build internal capabilities.
The acquisition of Proficiency doubled the company's Total Addressable Market (TAM) from $4 billion to $8 billion, expanding its reach into clinical operations with predictive analytics.
Simulations Plus is launching GastroPlus with new cloud and AI technology at the end of September 2025, with plans to roll out cloud capabilities across other platforms, and views the FDA's shift away from animal models as a long-term growth tailwind.

Sep 3, 2025, 6:06 PM

Simulations Plus Under Investigation by Bragar Eagel & Squire, P.C.

SLP

Legal Proceedings

Guidance Update

Profit Warning

Bragar Eagel & Squire, P.C. is investigating Simulations Plus, Inc. for potential violations of federal securities laws and/or unlawful business practices on behalf of its stockholders.
The investigation follows Simulations Plus's third fiscal quarter results, reported on July 14, 2025, which included sales of $20.4 million (missing consensus), a net loss of $67.3 million, and a diluted loss per share of $3.35, reflecting a $77.2 million non-cash impairment charge.
Simulations Plus also revised its fiscal 2025 adjusted earnings guidance downward to $0.93 to $1.06 from the previous $1.07 to $1.20.
Following this news, Simulations Plus's stock price fell $4.50 per share, or 25.76%, to close at $12.97 per share on July 15, 2025.