Summary of Simulations Plus Investor Day - January 21, 2026 Company Overview - **Company**: Simulations Plus (NasdaqGS:SLP) - **Industry**: Biopharmaceutical modeling and simulation - **Focus**: Drug development, commercialization, and scientific consulting Core Points and Arguments Industry Transformation - The biopharma industry is undergoing significant changes, including: - Adoption of AI - Shift towards cloud-native scientific computation - Move away from animal testing - Increased reliance on model-informed drug development [2][12][50] Company Vision and Mission - **Vision**: Improve quality of life through innovative solutions - **Mission**: Create value for clients by accelerating the discovery, development, and commercialization of pharmaceuticals through science-based software and consulting solutions [3][2] Unique Value Proposition - Simulations Plus differentiates itself through: - A combination of scientific excellence and technological innovation - A robust suite of software products including GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, and Thileys [4][5] - The company is evolving from point solutions to an integrated cloud-enabled ecosystem [5] Market Opportunity - Total Addressable Market (TAM) is approximately $12.5 billion: - $4 billion in traditional biosimulation - $8.5 billion in clinical trial training and medical communications [6] Client Needs and Industry Pressures - Clients face pressures from: - Economic factors increasing the cost and complexity of drug development - Scientific complexity requiring advanced modeling techniques - Technological expectations for integrated digital infrastructure [10][11][12] Regulatory Environment - Regulatory agencies are pushing for broader use of model-informed drug development and non-animal methodologies, which aligns with Simulations Plus's offerings [12][56] Strategic Shift - The company is transitioning from a tool provider to an ecosystem partner, focusing on integrated workflows and AI-assisted solutions [14][28] Additional Important Insights Product Strategy and Roadmap - The company is building a unified AI-orchestrated ecosystem that connects various aspects of drug development [20][25] - The architecture includes: - Validated modeling engines - Composition layer for data standardization - Grounded intelligence layer with AI copilots - Orchestration layer for automating workflows [21][22][24] Services and Consulting - Simulations Plus's services complement its product offerings by providing scientific consulting that informs software enhancements and optimizes workflows [33][34] - The consulting teams help clients navigate complex drug development decisions, reducing uncertainty and costs [34][35] Case Studies - Case studies illustrate the effectiveness of Simulations Plus's approach in reducing development timelines and costs while improving clinical trial success rates [41][43] Future Growth and Revenue Opportunities - The acquisition of Pro-ficiency has doubled the TAM and is expected to contribute to future growth [54][55] - The company anticipates increased demand for simulation and modeling services driven by FDA's NAMs guidance [56][58] Pricing Evolution - The company is evolving its pricing strategy to reflect the added value of its integrated ecosystem, with new monetization opportunities expected as the ecosystem matures [29][30] Conclusion - Simulations Plus is well-positioned to lead in the evolving landscape of model-informed drug development, leveraging its scientific expertise, technological innovations, and strategic partnerships to create a cohesive platform that meets the industry's growing demands [53]

Core Insights - Simulations Plus Inc. reported better-than-expected fourth-quarter 2025 earnings and reaffirmed annual guidance, leading to a rise in stock price [1] Financial Performance - The company reported sales of $17.5 million, a 6% year-over-year decline, but slightly above the consensus estimate of $17.09 million [2] - Adjusted earnings were 10 cents per share, surpassing the consensus loss of 5 cents, down from 18 cents a year ago [2] - Gross profit was $9.8 million, achieving a 56% margin, while adjusted EBITDA was $3.5 million, representing 20% of total revenue, down from $4.1 million or 22% of total revenue [3] Guidance - Simulations Plus reaffirmed its fiscal 2026 adjusted earnings guidance of $1.03 to $1.10, compared to the consensus loss of $3.22 [4] - The company expects 2026 sales guidance of $79 million to $82 million, slightly above the consensus of $78.797 million [4] - An adjusted EBITDA margin of 26% to 30% is anticipated for 2026 [4] Market Outlook - Management indicated that demand appears to be stabilizing due to improved biotech funding and easing tariff and drug-pricing concerns, which has increased proposal activity [5] - The company remains cautious, seeking clearer signs of sustained recovery before confirming a rebound [5] - Simulations Plus is well-positioned to capitalize on future demand rebounds, especially with investments in AI solutions and a unified product ecosystem [6] Analyst Sentiment - Analysts from William Blair express confidence in the company's potential for consistent double-digit organic revenue growth and margin expansion over time [7] - The stock price increased by 18.38% to $20.26 following the earnings report [7]

Company Overview - Simulations Plus is celebrating its 30th anniversary, indicating a long-standing presence in the biosimulation market [2] - The company specializes in biosimulation, which supports drug development through the integration of technology, science, mathematics, and various biological disciplines [3] Product and Services - The platform offers a comprehensive range of solutions that cover the entire drug development process, from early-stage discovery to clinical studies and post-approval applications [4] - Biosimulation is utilized to enhance efficiency and accelerate timelines in drug development, including applications in animal testing and clinical trials [4][5] Industry Context - The acceptance of biosimulation has grown over the years, gaining recognition from both scientific communities and drug sponsors [5]

Core Insights - Simulations Plus is celebrating its 30th anniversary, indicating its established presence in the biosimulation market [2] - The company utilizes a combination of technology, science, mathematics, and various disciplines to develop in silico models that enhance drug development efficiency [3] Company Overview - Simulations Plus offers a comprehensive platform that supports various stages of drug development, from early discovery to clinical studies and post-approval applications [4] - The platform includes applications for lead optimization, preclinical translational impact, and modeling that supports bioequivalence waivers [4] Industry Context - Biosimulation has gained acceptance over the years from scientific and drug sponsor perspectives, highlighting its importance in the drug development process [5]

Summary of Simulation Plus Conference Call Company Overview - Simulation Plus is celebrating its 30th anniversary, indicating a long-standing presence in the bio simulation market [2] - The company specializes in software licensing and scientific consulting services to support drug development [4] Industry Insights - Bio simulation combines technology, science, and regulatory support to enhance drug development efficiency [3] - The FDA has shown increasing support for bio simulation, particularly in reducing animal testing requirements [3][22] Core Business and Services - The company provides tools for various stages of drug development, including discovery, preclinical, and clinical phases [5][6] - Key products include: - **Admet Predictor**: Focused on early-stage applications, representing 15% of client support [6][7] - **GastroPlus**: A PBPK modeling tool used extensively in translational medicine and clinical trial design [7][8] - **PKPD Modeling**: Used for profiling drugs and patient stratification, crucial for personalized medicine [8] AI and Drug Development - AI has been integrated into the company's products for decades, enhancing data analysis and candidate identification [9][10] - The use of AI is seen as a revolutionary tool in drug development, improving efficiency and success rates [10][12] - Challenges include ensuring data quality and managing large datasets effectively [11][13] Regulatory Environment - The FDA's roadmap to reduce animal testing presents opportunities for Simulation Plus, as biosimulation can potentially replace some traditional methods [22][23] - The adoption of biosimulation is expected to grow, but the process will take time due to regulatory scrutiny [24][25] Market Challenges - The biopharma and biotech sectors are currently facing a challenging demand environment, with cost constraints and low funding impacting client investments [31][32] - Despite these challenges, there is a strong need for improved ROI in drug development, which bio simulation can address [33][34] Strategic Realignment - The company has undergone a reorganization to create a more functional organization, enhancing collaboration across different scientific domains [35][36] - The integration of products and development of cloud technology aims to accelerate the company's roadmap and improve client offerings [37] Future Opportunities - The company is focused on staying current with advancements in science and regulatory guidance, particularly in oncology and other therapeutic areas [39][41] - There is a long runway for biosimulation value in drug development, with ongoing opportunities for innovation and market solutions [41][42]

Core Insights - Certara reported Q2 FY2025 earnings with GAAP revenue of $104.6 million, slightly exceeding analyst expectations, but non-GAAP EPS missed consensus by $0.03 [1][2] - The company experienced double-digit top-line growth primarily driven by its software segment, while the bottom line faced ongoing pressure [1][4] - GAAP net losses narrowed significantly year over year, indicating improved financial performance despite challenges in profitability [1][2] Financial Performance - Q2 2025 GAAP revenue was $104.6 million, a 12% increase from $93.3 million in Q2 2024 [2] - Non-GAAP EPS was $0.07, unchanged from the previous year, but below the estimate of $0.10 [2] - Adjusted EBITDA rose 21% year over year to $31.9 million, with an adjusted EBITDA margin of approximately 30% [2][8] - GAAP net income showed a loss of $2.0 million, a significant improvement from a loss of $12.6 million in Q2 2024, reflecting an 84.1% year-over-year reduction in losses [2] Business Segments - The software segment generated $46.7 million in revenue, marking a 22.3% increase from $38.2 million in Q2 2024, driven by organic sales and the acquisition of Chemaxon [2][5] - The services segment saw slower growth, with GAAP revenue up only 5%, but bookings increased by 15%, indicating potential future revenue growth [6][7] - The Non-Animal Navigator solution received strong interest, with over 400 webinar attendees, although its financial impact is expected to take time [6] Strategic Focus - Certara is focused on expanding its AI and machine learning capabilities within its software suite and integrating new technologies through acquisitions [4][9] - The company has made 21 acquisitions since 2013, enhancing its technology and global reach, serving over 2,400 biopharmaceutical companies [10] - Certara's tools have contributed to a majority of new drug approvals by the FDA, positioning the company favorably as regulatory standards evolve [11] Future Outlook - For FY2025, Certara targets revenue of $415–$425 million, adjusted EBITDA margins of 30–32%, and adjusted diluted EPS of $0.42–$0.46, indicating expected growth in the high single digits [13] - Management noted steady demand for biosimulation and increasing interest in model-informed solutions, while emphasizing the need for improvement in the services segment [13][14]

Core Insights - Certara, Inc. has received formal qualification from the European Medicines Agency (EMA) for its Simcyp® Simulator, marking it as the first company to achieve this for a PBPK modeling platform [1][2] - The qualification allows sponsors to use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk, streamlining the drug submission process [2][3] - The recognition reflects Certara's scientific leadership and innovation in biosimulation, which is increasingly prioritized in drug development [3] Company Overview - Certara accelerates medicine development through biosimulation software and services, serving over 2,400 clients including biopharmaceutical companies and regulatory agencies in 70 countries [4]