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]

Summary of Certara Conference Call Company Overview - **Company**: Certara - **Industry**: Pharmaceutical services supply chain, focusing on biosimulation and regulatory services Key Points Q3 Results and Market Reaction - Certara experienced a slowdown in bookings at the end of Q3, which alarmed the market [4] - The company had lower-than-expected bookings, particularly in the regulatory business, which has been volatile [5] - Despite the slowdown, Certara reported strong results with tier three biotech clients, indicating a successful strategy focusing on venture capital companies [4][6] Regulatory Business Review - The regulatory business has been under strategic review for over a year due to volatility and current disruptions at the FDA [8] - Certara expects the regulatory environment to stabilize by 2026, but the business is not considered strategically important as it once was [9][11] Biosimulation and Market Trends - Certara holds a leadership position in biosimulation, benefiting from FDA initiatives to reduce animal testing [12][15] - The company is seeing increased interest in biosimulation from clients, particularly in monoclonal antibody development [13][14] - Certara's QSP (Quantitative Systems Pharmacology) business is growing, with the launch of Certara IQ aimed at becoming a standard software product in the market [35] Service Bookings and Client Dynamics - Tier three services have been strong, while tier one clients showed a slowdown in service bookings [20] - Certara has focused on financial sponsors and larger VCs to stabilize its client base [21] - The company has a large backlog of work, indicating potential for future growth as the market recovers [22] Pricing Environment - The current pricing environment is weaker, with mid-single-digit pricing increases on software products being tempered [24] - Certara is prioritizing the growth of biosimulation usage over immediate price increases [24] Product Development and Innovation - Certara has expanded its software offerings, including new versions of Simcyp targeted at preclinical and formulation scientists [28][29] - The company is evolving its software portfolio into a cloud-based platform, with plans for further integration and AI enhancements by 2026 [39][41] Economic and Regulatory Pressures - Certara faces hesitancy from clients to spend due to uncertainties in the regulatory environment and macroeconomic factors [44] - Despite these challenges, there is a long-term trend towards increased interest in modeling as a cost-effective solution in pharma [45][46] Conclusion - Certara is navigating a complex environment with both challenges and opportunities, particularly in biosimulation and regulatory services, while maintaining a strong pipeline and backlog of work [22][23]

Third Quarter 2025 Financial Results November 6, 2025 Disclaimer Numerical figures in the presentation have been subject to rounding adjustments. Accordingly, numerical figures shown as totals in various tables may not be arithmetic aggregations of the figures that precede them. In addition, unless otherwise indicated, references to the "Company," "Certara," "we," "us," and "our" refer to Certara, Inc. and its consolidated subsidiaries. Trademarks and Service Marks The Certara design logo, "Certara," and ou ...

Core Insights - Certara, Inc. reported a total revenue of $104.6 million for Q3 2025, reflecting a year-over-year growth of 10% [4][8] - The company has raised its profitability targets for 2025 and narrowed its revenue guidance to a range of $415 million to $420 million [3][15] - The CEO emphasized the launch of new software products, particularly CertaraIQ for QSP modeling, aimed at enhancing biosimulation technology in drug development [3] Financial Performance - Total revenue for Q3 2025 was $104.6 million, with software revenue at $43.8 million (22% growth) and services revenue at $60.8 million (3% growth) [4][5][8] - Total bookings reached $96.6 million, a 1% increase year-over-year, with software bookings growing by 17% [6][8] - Net income for Q3 2025 was $1.5 million, a significant improvement from a net loss of $1.4 million in Q3 2024, marking a 211% increase [12][8] Cost and Expenses - Total operating expenses for Q3 2025 were $61.9 million, up from $55.0 million in Q3 2024, primarily due to increased employee-related costs and stock-based compensation [10][8] - The cost of revenues was $39.7 million, an increase from $37.2 million in the same quarter last year [7][8] Adjusted Metrics - Adjusted EBITDA for Q3 2025 was $35.2 million, a 7% increase from $33.1 million in Q3 2024 [11][8] - Adjusted net income for Q3 2025 was $22.2 million, compared to $20.3 million in Q3 2024 [13][8] - Adjusted diluted earnings per share for Q3 2025 was $0.14, slightly up from $0.13 in Q3 2024 [13][8] Guidance and Outlook - The company expects full-year adjusted EBITDA margin to be approximately 32% and adjusted diluted earnings per share in the range of $0.45 to $0.47 [15] - Certara aims to continue investing in R&D and commercial efforts to ensure sustainable long-term growth [3]

Core Insights - Certara, Inc. has published over 200 papers in the past year and has 11 scientists listed among the top 2% most cited researchers globally according to the 2025 Stanford/Elsevier ranking, highlighting its significant impact in pharmaceutical research [1][2][3] Company Achievements - The company has maintained its leadership in pharmacology and pharmacokinetics, with its scientists recognized for their contributions either in the calendar year 2024 or throughout their careers [3] - Amin Rostami-Hodjegan, a key figure at Certara, received the 2025 Lewis B. Sheiner Lecturer Award for his lifetime achievements in pharmacometric research [4] Technological Innovations - The Simcyp Simulator®, co-founded by Rostami-Hodjegan, is utilized by over 11 global regulatory agencies and has supported more than 120 FDA-approved drugs, demonstrating its effectiveness in drug development [4] - The Simcyp Consortium, consisting of 35 leading biopharmaceutical companies, is recognized as a global authority on mechanistic PBPK modeling and simulation [4] Industry Trends - New methodologies like the Simcyp Simulator are crucial as the biopharma industry shifts away from animal testing, a transition supported by the FDA and NIH [5] - Certara has been at the forefront of reducing animal use in pre-clinical research for the past 25 years, aligning with industry trends towards more ethical research practices [5]

Core Viewpoint - Certara, Inc. will release its financial results for Q3 2025 on November 6, 2025, after market close, followed by a conference call to discuss the results [1]. Company Overview - Certara is a global leader in biosimulation, utilizing software, technology, and services to enhance drug discovery and development [3]. - The company serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [3]. Event Details - A conference call will be held at 5:00 PM ET on the same day as the financial results release, and investors must register online to participate [1]. - It is recommended that investors register at least one day in advance [1]. - A live and archived webcast of the event will be available on Certara's website [2].

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, Inc. has launched Pinnacle 21 Enterprise Plus, a solution designed to enhance the efficiency of clinical and statistical programmers in creating and managing data specifications for CDISC SDTM and ADaM datasets, achieving a 50% reduction in time spent on drafting mapping specifications [1][2]. Company Overview - Certara is a global leader in biosimulation, providing software and services that accelerate drug discovery and development, with a client base of over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [7]. Product Features - Pinnacle 21 Enterprise Plus offers a unified, collaborative workspace that addresses the limitations of traditional spreadsheet-based methods, such as errors and lack of version control [2]. - The solution is purpose-built for clinical and statistical programmers, allowing most teams to go live in less than a month [4]. - The platform supports compliance with both CDISC and company-specific standards through configurable columns, ensuring maximum flexibility [8]. - It facilitates seamless integration with downstream programming tools like SAS and R via application programming interfaces (APIs) [8]. Strategic Importance - The launch of Pinnacle 21 Enterprise Plus is seen as a significant milestone in Certara's roadmap, aimed at building a future-proof platform for end-to-end data standardization and validation [5]. - The innovations introduced are expected to shorten cycle times and accelerate regulatory submissions of new therapies, benefiting patients [3]. Market Position - Certara's Pinnacle 21 solutions are trusted by over 130 organizations globally, including leading biopharmaceutical companies and regulatory agencies like the US FDA and Japan's PMDA, reinforcing its leadership in clinical data standardization and validation [5].