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Simulations Plus, Inc.
12/1/2025
Greetings, and welcome to the Simulations Plus fourth quarter and full fiscal 2025 financial results conference call. All participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. It is now my pleasure to introduce Lisa Fortuna from Financial Profiles. Ms. Fortuna, please go ahead.
Good afternoon, everyone. Welcome to the Simulations Plus fourth quarter fiscal year 2025 financial results conference call. With me today are Sean O'Connor, Chief Executive Officer, and Will Frederick, Chief Financial Officer of Simulations Plus. Please note that we updated our quarterly earnings presentation, which will serve as a supplement to today's prepared remarks. You can access the presentation on our investor relations website at simulations-plus.com. After management's commentary, we will open the call for questions. As a reminder, the information discussed today may include forward-looking statements that involve risks and uncertainties. Words like believe, expect, and anticipate refer to our best estimates as of this call, and actual future results could differ significantly from these statements. Further information on the company's risk factors is contained in the company's quarterly and annual reports and filed with the Securities and Exchange Commission. In the remarks or responses to questions, management may mention some non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to those most directly comparable GAAP measures are available in the most recent earnings release available on the company's website. Please refer to the reconciliation tables and the accompanying materials for additional information. With that, I'll turn the call over to Sean O'Connor. Please go ahead.
Thank you, Lisa, and welcome, everyone. We closed fiscal 2025 with strong execution across the business, delivering on the full-year guidance we set in June. Revenue grew 13%, adjusted EBITDA grew 8%, and adjusted EPS grew 8%, demonstrating resilience and operational discipline in a year marked by significant market volatility. Importantly, 2025 was also a strategic reset for Simulations Plus. We completed our transition to a unified operating model, aligning product and technology, scientific R&D, strategic consulting services, and business development into a single client-focused, functionally-oriented organization structure. This shift is already improving how we prioritize, build, and deliver for our customers and positions us to move faster for the opportunities ahead. The external environment remained challenging throughout the year. Client budgets were pressured by broader pharmaceutical headwinds, including the threat of tariffs and most favored nation pricing implementation, which created real disruption starting mid-year. As we move toward calendar 2026, we're seeing early signs of stabilization. Large pharma has clearer visibility into pricing frameworks, biotech funding has improved modestly, and our clients have entered their budgeting cycles with more confidence. Proposal activity and conference engagement have both strengthened. That said, we believe uncertainty will persist in the overall environment in the near term. Despite these challenges, the momentum behind biosimulation continues to accelerate. Our biopharma and regulatory partners are scaling their internal model and form development capabilities, investing in data curation and digital infrastructure, and increasingly incorporating AI into modeling workflows. The convergence of cloud computing AI, and model-informed drug development is reshaping how the R&D teams within our biopharma clients operate, and our validated science puts us at the center of that shift. We started laying the groundwork for this future with the release of GastroPlus 10.2 earlier this year, and we'll continue with portfolio-wide updates in fiscal 2026. As our customers expand their internal biosimulation capabilities, they are turning to partners who can deliver scientific rigor, integrated workflows, and AI-assisted efficiency, all grounded in regulatory grade and scientifically validated models. Our product vision directly aligns with these needs, connecting advanced science, cloud-scale computation, and AI-driven services into a unified ecosystem that supports teams through discovery, through clinical development, and commercialization. Taken together, these trends reinforce the long-term demand for our solutions and our leadership in the field. What we are hearing consistently from clients is that biosimulation is no longer a set of point solution tools. It's becoming the backbone of how R&D organizations operate. Teams want faster cycle times, stronger interoperability, and AI assisted workflows that reduce manual effort while preserving scientific rigor. They want systems that help them organize their data, standardize their modeling approaches, and deliver reproducible results for regulatory submission. This is exactly where our strategy is headed. Over the past year, we have been building toward an integrated product ecosystem that combines three strengths Simulations Plus can offer. Validated science, cloud-scale performance, and AI that is grounded in regulatory-grade modeling. In fiscal 2026, that strategy comes into focus. Across GastroPlus, Monolix Suite, AdMet Predictor, our QSP platforms, and proficiency, we are enabling advanced science, continuous investment in the scientific engines trusted by global regulators and leading R&D teams, a connected ecosystem, interoperability across products powered by the simulations plus cloud to support end-to-end modeling workflows from discovery through clinical development. AI-driven services, tools that enhance data curation, accelerate simulation, interpretation, and streamline regulatory compliant reporting. AI and human collaboration, co-pilots and reusable modules that improve efficiency, consistency, and delivery times for scientists and consultants alike. These enhancements are not abstract concepts. They are tied directly to customer pain points and to the direction the industry is moving. And importantly, they position us to bring new capabilities to market with greater speed and cohesion than at any point in our history. We look forward to sharing much more detail about this integrated product strategy at our Virtual Investor Day in January, including the roadmap that unifies our scientific engines, cloud infrastructure, and AI capabilities into a modern, interoperable biosimulation ecosystem. With that, I'll turn the call over to Will.
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