Here are 1-3 brief analogies for Simulations Plus (SLP):

• Adobe for drug discovery and development: SLP provides essential, specialized software tools for pharmaceutical and biotech professionals, much like Adobe does for creative professionals.
• Autodesk for pharmaceutical research: Similar to Autodesk's role in providing design and modeling software for engineers and architects, SLP offers powerful simulation tools for scientists in drug development.

• GastroPlus™: A leading physiologically-based pharmacokinetic (PBPK) modeling and simulation software used to predict drug absorption, distribution, metabolism, and excretion.
• ADMET Predictor™: Cheminformatics software that leverages machine learning to predict physicochemical and ADMET properties of drug candidates directly from their chemical structures.
• DILIsym®: Mechanistic modeling software designed to simulate and assess the risk of drug-induced liver injury (DILI) for new compounds.
• NAFLDsym®: Mechanistic modeling software used to simulate the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), aiding in therapeutic development.
• MonolixSuite™: A comprehensive suite of software tools for population pharmacokinetic and pharmacodynamic (PK/PD) modeling and simulation, essential for analyzing clinical trial data.

Simulations Plus (SLP) Major Customers

Simulations Plus (SLP) primarily sells its software and consulting services to other companies and institutions, operating on a business-to-business (B2B) model rather than directly to individuals.

According to its most recent annual filings, including the 10-K for the fiscal year ended August 31, 2023, no single customer accounted for 10% or more of Simulations Plus's consolidated net revenues. This indicates that the company has a diversified customer base rather than relying on a few specific "major customers" that would require individual disclosure. Therefore, specific names of major customer companies with their symbols cannot be provided.

However, Simulations Plus broadly serves the following categories of organizations:

• Pharmaceutical Companies: Large and small pharmaceutical firms utilizing SLP's software for drug discovery, development, and regulatory submissions.
• Biotechnology Companies: Biotech firms focused on developing new therapeutic products, often leveraging SLP's modeling and simulation tools.
• Academic Institutions and Research Centers: Universities and research organizations that use the company's platforms for scientific research and education.
• Government Agencies: Regulatory bodies and public health organizations that employ SLP's solutions for various research and assessment purposes.

• Amazon.com, Inc. (AMZN)

Shawn O'Connor, Chief Executive Officer

Mr. O'Connor has served as Chief Executive Officer of Simulations Plus since 2018. Prior to joining Simulations Plus, he was President, Chief Executive Officer, and Director at Entelos, Inc. from 2011 to 2018. From 2002 to 2009, Mr. O'Connor served as Chairman, President, and Chief Executive Officer at Pharsight Corporation, where he developed a software product strategy that resulted in a 20x increase in valuation. His earlier career included roles as Chief Financial Officer at Diasonics Ultrasound, Inc. from 1988 to 1994, and President, Chief Operating Officer, and Chief Financial Officer at QRS Corp. from 1995 to 2000.

Will Frederick, Chief Financial Officer and Chief Operating Officer

Mr. Frederick was appointed Chief Financial Officer of Simulations Plus in December 2020, and assumed the additional role of Chief Operating Officer in January 2024. He brings over 25 years of financial leadership experience to the company, with a proven track record in driving revenue growth, increasing profitability, and managing merger and acquisition activities. His global experience spans both publicly traded and privately held companies, including Pharsight, Entelos, Avaya, The Walt Disney Company, and Ford Motor Company. Notably, he previously served as CFO at Pharsight and Entelos during the periods when Shawn O'Connor was CEO of those companies.

Walter S. Woltosz, Board Member

Mr. Woltosz is a cofounder of Simulations Plus and served as its Chief Executive Officer until June 2018. He has been a director of the company since June 1996, and was Chairman of the Board from July 1996 to December 2024. In 1981, he established Words+, Inc., a company specializing in computer-based communication systems, including the system famously used by Professor Stephen Hawking. The initial capital for Simulations Plus originated from a settlement Mr. Woltosz received related to the development of an ADA assistive device.

Viera Lukacova, Chief Science Officer

Dr. Lukacova is the Chief Science Officer at Simulations Plus and has been with the company for approximately 15 years. She is instrumental in working on the company's GastroPlus®, DDDPlus™, and MembranePlus™ software packages and contributes to modeling studies that assist companies with their drug development programs. Her expertise lies in mechanistic absorption and PBPK modeling, and she holds a Ph.D. in Pharmaceutical Sciences.

John A. DiBella, Chief Revenue Officer

Mr. DiBella serves as the Chief Revenue Officer for Simulations Plus, a position he assumed effective May 30, 2025. He has been with the company since 2003, and prior to his current role, he served as the Business Unit President for PBPK and Cheminformatics Solutions.

The key risks to Simulations Plus's business are multifaceted, stemming from recent financial and governance challenges, ongoing profitability concerns, and the inherent competitive dynamics of its industry.

1. Securities Lawsuits, Governance Issues, and Acquisition-Related Impairments: Simulations Plus is currently embroiled in multiple class-action lawsuits alleging securities fraud. These legal challenges follow a significant non-cash impairment charge of $77.2 million related to the Pro-ficiency acquisition, which also contributed to a substantial stock price plunge and an auditor change. These issues indicate serious financial, reputational, and governance risks, raising questions about the company's M&A strategy and internal controls.

2. Declining Margins and Profitability Challenges: Despite demonstrating revenue growth, Simulations Plus has faced significant declines in its gross and net margins, as well as its operating profit margin. This points to potential cost management issues and challenges in translating revenue expansion into sustained profitability. The shift in business mix, potentially influenced by acquisitions with lower gross margins, has been identified as a factor contributing to this margin pressure.

3. Competitive Pressures and Market Conditions: The company operates within a competitive healthcare software industry. It faces competition from existing players and the evolving risk of clients developing their own in-house artificial intelligence (AI) solutions for drug discovery. Furthermore, Simulations Plus has encountered "significant headwinds" due to broader market uncertainties in the biopharma sector, including funding constraints, drug pricing pressures, and potential tariffs, leading to reduced client spending, project cancellations, and delays.

The rapid advancement and adoption of integrated Artificial Intelligence (AI) and Machine Learning (ML) platforms for drug discovery and development pose a clear emerging threat. These platforms, either developed by AI-first drug discovery companies (e.g., Insilico Medicine, Recursion Pharmaceuticals) or as sophisticated in-house capabilities within large pharmaceutical companies, aim to automate and optimize various stages of drug research, including predictive modeling and simulation. This trend could potentially reduce the reliance on external, specialized software vendors for specific modeling tasks that Simulations Plus currently provides, as these capabilities become more integrated into broader AI-driven workflows.

For Simulations Plus (SLP), the addressable markets for their main products and services are as follows:

• Biosimulation Market: The global biosimulation market was valued at approximately USD 4.24 billion in 2024 and is projected to reach USD 9.18 billion by 2029.
• In-Silico Drug Discovery Market: The global in-silico drug discovery market was valued at USD 3.6 billion in 2024 and is projected to reach USD 6.8 billion by 2030. North America accounted for the largest revenue share of 40.5% in 2024.
• Clinical Trial Simulation Tools Market: The global clinical trial simulation tools market was estimated at USD 1.47 billion in 2024 and is expected to reach USD 2.91 billion by 2032.
• PBPK Modeling and Simulation Software Market: The global PBPK modeling and simulation software market size was valued at US$ 363.5 million in 2024 and is estimated to grow to US$ 926.5 million by 2030.
• Quantitative Structure-Activity Relationship (QSAR) Market: The global Quantitative Structure-Activity Relationship (QSAR) market size was USD 1,658.6 million in 2024 and is projected to reach USD 2,493.9 million by 2031. North America held over 40% of the global revenue with a market size of USD 663.44 million in 2024.

Simulations Plus (SLP) is expected to drive future revenue growth over the next 2-3 years through several key strategies and market trends:

1. Strategic Acquisitions and Integration: The successful integration and ongoing contributions from recent acquisitions, notably Pro-ficiency, are anticipated to fuel revenue growth. For instance, Pro-ficiency contributed significantly to total revenue in fiscal year 2024 and is expected to continue to do so in fiscal year 2025, particularly within the medical communications and adaptive learning and insights business units. The company's strategy includes combining organic growth with strategic acquisitions to expand its product line and address evolving drug development needs.
2. Advancements and Expansion of Core Software Products: Growth in core software platforms like GastroPlus, ADMET Predictor, and MonolixSuite is a consistent driver. The company is continuously enhancing these products with new features and capabilities, such as the launch of ADMET Predictor 13 with improved predictive power and the upcoming upgrade of GastroPlus with enhanced AI capabilities. The recent launch of GastroPlus X.2, which introduces AI-powered tools on the S+ Cloud platform, further exemplifies this.
3. Integration of AI and Cloud Technologies: Simulations Plus is committed to rolling out a series of new AI-driven initiatives and developing cloud platforms across its product suite. This focus on AI and cloud integration is expected to drive future growth and innovation by enhancing the usefulness and applications of model-informed drug development.
4. Expanding Services Revenue, particularly Medical Communications: While some service areas have faced headwinds, the Medical Communications business unit (acquired through Pro-ficiency) has been a primary driver of services revenue growth. The company is optimizing its business unit structure to enhance customer engagement and accelerate cross-selling opportunities for its biosimulation solutions.
5. Increased Adoption of Biosimulation in Drug Development and Regulatory Acceptance: The broader market trend of increased demand for biosimulation software and services is a significant driver. Regulatory bodies, such as the FDA, are increasingly promoting computer modeling over animal testing, as highlighted by the FDA Modernization Act 2.0. This shift positions Simulations Plus's software and consulting services for long-term relevance and growth by improving drug candidate selection, accelerating clinical development, and streamlining regulatory approval.

Share Repurchases

• Simulations Plus authorized a $50 million share repurchase program on December 29, 2022.
• In January 2023, the company executed a $20 million accelerated share repurchase agreement.
• Following the accelerated share repurchase, $30 million remained available under the authorized repurchase program.

Share Issuance

• The number of shares outstanding was approximately 19,967,077 as of December 27, 2023.
• As of June 30, 2025, Simulations Plus had approximately 20.1 million shares outstanding.
• The number of shares outstanding was approximately 20.13 million as of November 4, 2025.

Inbound Investments

• Simulations Plus received an undisclosed amount in a Grant (prize money) funding round on November 13, 2024, with investors including the FDA, NIH, and HHS.
• In the fiscal year ended August 31, 2024, the company participated in nine funded grants from the U.S. Food and Drug Administration (FDA) aimed at enhancing PBPK modeling science.

Outbound Investments

• In June 2024, Simulations Plus acquired Pro-ficiency Holdings Inc. for approximately $100 million in cash, which significantly expanded its reach across the drug development value chain and doubled its addressable market.
• Simulations Plus acquired Immunetrics in June 2023 for $15.5 million.
• The company made one acquisition in 2020.

Capital Expenditures

• Simulations Plus' fiscal year 2024 capital expenditures (ending August 31, 2024) were $1.0 million.
• Capital expenditures for fiscal year 2023 (ending August 31, 2023) were $0.9 million.
• The company's capital expenditures for fiscal year 2022 (ending August 31, 2022) were $1.1 million.