Financial Data and Key Metrics Changes - Revenue for fiscal year 2025 increased by 13% to $79.2 million, while total revenue for the fourth quarter decreased by 6% to $17.5 million [4][10] - Adjusted EBITDA grew by 8%, and adjusted EPS also increased by 8% for the fiscal year [4] - Total gross margin for the fiscal year was 58%, down from 62% in the prior year, with software gross margin decreasing from 84% to 79% [13][15] Business Line Data and Key Metrics Changes - Software revenue decreased by 9% in Q4, representing 52% of total revenue, while services revenue decreased by 3%, representing 48% [10] - For the fiscal year, software revenue increased by 12%, accounting for 58% of total revenue, and services revenue increased by 15%, accounting for 42% [10] - Specific product performance: Admet Predictor declined by 10% in Q4 but grew by 5% for the fiscal year; GastroPlus declined by 3% in Q4 but grew by 1% for the fiscal year; Monolith Suite grew by 3% in Q4 and 14% for the fiscal year [11] Market Data and Key Metrics Changes - The company noted early signs of stabilization in the market, with large pharma gaining clearer visibility into pricing frameworks and biotech funding improving modestly [5][6] - Proposal activity and conference engagement have strengthened, indicating a more confident budgeting cycle among clients [5] Company Strategy and Development Direction - The company completed a strategic reset in fiscal 2025, transitioning to a unified operating model that aligns product and technology with client-focused services [4] - The focus for fiscal 2026 includes enhancing biosimulation capabilities, integrating AI into workflows, and developing a connected ecosystem of products [8][9] - The company aims to support clients through discovery, clinical development, and commercialization with a modern, interoperable biosimulation ecosystem [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about the future, noting that while uncertainty persists, there are positive trends in biotech funding and client budgeting [5][6] - The company anticipates a stable operating environment for fiscal 2026, with guidance for total revenue between $79 million and $82 million, reflecting year-over-year growth of 0%-4% [16] Other Important Information - The company ended the fiscal year with $32.4 million in cash and short-term investments, remaining well-capitalized with no debt [15][16] - The effective tax rate for the fiscal year was 7%, with expectations for fiscal 2026 to be in the range of 12%-14% [15] Q&A Session Summary Question: Update on demand environment and trends - Management noted an uptick in biotech funding and positive discussions with clients regarding proposals and budgeting for the next year [21][22] Question: Feedback on GastroPlus release with AI capabilities - Initial responses to the AI-infused GastroPlus have been positive, with clients eager to leverage AI capabilities [24][25] Question: Factors affecting large pharma spending - Management indicated that while there are positive trends, caution remains due to individual client circumstances and the overall budgeting cycle [31][32] Question: Guidance assumptions and potential biotech recovery - The guidance assumes continued cautious optimism in biotech funding but does not project a significant uptick in revenue from this sector for 2026 [43][44] Question: Renewal rates and factors affecting them - Renewal rates have been impacted by client consolidations and budget scrutiny, but management expects improvement as clients have already reviewed their module needs [52][54] Question: Proficiency asset performance - Proficiency software revenue declined by 63% in Q4, while Med-Com services grew by 70%, indicating mixed performance post-acquisition [62][63] Question: Cash flow outlook and acquisition interest - Cash flow remains robust, and the company is actively looking for acquisition opportunities in biosimulation and clinical operations [72][73] Question: Pricing flexibility and plans for 2026 - The company plans to implement more aggressive pricing due to new AI capabilities, with expectations for a positive impact on renewal rates [76][77]

Financial Data and Key Metrics Changes - Revenue for fiscal year 2025 increased by 13% to $79.2 million, while total revenue for Q4 decreased by 6% to $17.5 million [10][11] - Adjusted EBITDA grew by 8%, and adjusted EPS also increased by 8% for the fiscal year [4] - Total gross margin for the fiscal year was 58%, down from 62% in the prior year, with software gross margin decreasing from 84% to 79% [14][16] Business Line Data and Key Metrics Changes - Software revenue for Q4 decreased by 9%, representing 52% of total revenue, while services revenue decreased by 3%, representing 48% of total revenue [10] - For the fiscal year, software revenue increased by 12%, representing 58% of total revenue, and services revenue increased by 15%, representing 42% of total revenue [10] - Discovery products contributed 18% to Q4 software revenue, while development products contributed 77% [10] Market Data and Key Metrics Changes - The company noted early signs of stabilization in the market, with large pharma gaining clearer visibility into pricing frameworks and biotech funding improving modestly [5] - Proposal activity and conference engagement have strengthened, indicating a more confident budgeting cycle among clients [5] Company Strategy and Development Direction - The company completed a strategic reset in 2025, transitioning to a unified operating model that aligns product and technology with client-focused services [4] - The focus is on building an integrated product ecosystem that combines validated science, cloud-scale performance, and AI capabilities [8][9] - The company aims to support clients through the entire drug development process, from discovery to commercialization, leveraging advancements in AI and cloud computing [6][18] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about the future, noting that while uncertainty persists, there are positive trends in biotech funding and client budgeting [5][18] - The company anticipates a stable operating environment for fiscal year 2026, with revenue guidance set between $79 million and $82 million [17] Other Important Information - The company ended the fiscal year with $32.4 million in cash and short-term investments, remaining well-capitalized with no debt [16] - The effective tax rate for the fiscal year was 7%, with expectations for 12%-14% in fiscal 2026 [16] Q&A Session Summary Question: Update on demand environment and trends affecting bookings and revenue - Management noted an uptick in biotech funding and positive discussions with clients regarding proposals and budgeting for the next year [21][23] Question: Feedback on the AI-infused GastroPlus release - Initial responses have been positive, with clients excited about the new capabilities and how they fit into their internal IT infrastructure [25][26] Question: Factors affecting large pharma spending and potential caution - Management highlighted that each client has unique challenges, but overall budgeting for 2026 appears positive [29][31] Question: Guidance details and underlying assumptions - No significant changes have occurred since the guidance was provided in October, with expectations for a stable revenue flow [36][38] Question: Renewal rates and factors affecting them - Renewal rates have been impacted by client consolidations and budget scrutiny, but management expects improvement as clients have already reviewed their needs [48][50] Question: Proficiency asset performance and revenue contributions - Proficiency software revenue was down 63% in Q4, while services revenue grew 70%, indicating a slowdown in clinical trial starts [55][56] Question: Cash flow outlook and acquisition interest - Cash flow remains robust, and the company is actively looking for acquisition opportunities in biosimulation and clinical operations [62][64] Question: Pricing flexibility and plans for the upcoming year - The company plans to implement more aggressive pricing due to new AI capabilities, but service side pricing will remain competitive [66][68]

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]

Financial Data and Key Metrics Changes - The biosimulation market has historically grown at a 15% CAGR but has fallen below that over the last couple of years, with the company achieving 10% organic growth during this period [15][18] - The company's revenue guidance was adjusted due to project cancellations and delays, impacting the expected growth trajectory [16][18] Business Line Data and Key Metrics Changes - The business is composed of approximately 60% software licensing and 40% consulting services, with the software side remaining relatively unaffected by recent market challenges [17][20] - Renewal rates for software licenses remain consistent at over 90%, with fluctuations primarily due to client bankruptcies and consolidations [20][21] Market Data and Key Metrics Changes - The drug development industry is facing cost constraints and reduced funding, leading to tighter budgets among clients [14][15] - The FDA's recent announcements regarding the reduction of animal testing requirements are seen as a potential tailwind for the biosimulation market, which could enhance growth opportunities [23][24] Company Strategy and Development Direction - The acquisition of Proficiency has expanded the company's total addressable market (TAM) from $4 billion to $8 billion, allowing for increased opportunities in clinical operations [5][6] - The company is focusing on integrating various modeling and simulation techniques to enhance product offerings and cross-selling opportunities [29][30] Management's Comments on Operating Environment and Future Outlook - Management noted that the drug development industry does not respond well to surprises, which has led to a slowdown in project approvals and contract negotiations [16][18] - The company anticipates a return to a more steady flow of project requests in fiscal year 2026, with expectations of regaining a growth rate closer to 15% [18][19] Other Important Information - The company is launching a cloud-based platform, Astra Plus, which is expected to enhance functionality and accessibility for clients [33][34] - The integration of AI technology into the company's products is a key focus for future development [31][34] Q&A Session Summary Question: What are the expectations for renewal rates and future fiscal year performance? - Renewal rates are expected to remain stable at over 90%, with the service side impacted by client cancellations but the software side performing well [20][21] Question: How is the FDA's movement away from animal models affecting the company? - The FDA's announcements regarding biosimulation and animal testing are seen as positive developments that could lead to increased adoption of the company's tools [23][24] Question: What is the company's growth formula regarding new and existing clients? - Software revenue typically comes from 80% renewals, 10% upsells, and 10% new clients, with a focus on cross-selling opportunities [29][30]