Summary of Certara (CERT) FY Conference Call - June 04, 2025 Company Overview - **Company**: Certara (CERT) - **Industry**: Pharmaceutical Drug Development - **Focus**: Model-informed drug development and biosimulation to improve drug development efficiency and success rates Key Points and Arguments 1. **Drug Development Challenges**: Nearly 90% of new medicines entering clinical trials fail, with development costs ranging from $2 to $3 billion, primarily due to unsuccessful trials [3][4] 2. **Impact of Improvements**: A mere 3% improvement in drug development success rates could save approximately $300 million per approved drug [5] 3. **Biosimulation Platform**: Certara's biosimulation platform allows for modeling disease and drug interactions, helping clients save time and costs while enhancing scientific understanding [6] 4. **Client Base**: Certara serves around 2,400 customers, including all major pharmaceutical companies, with over 90% of FDA-approved drugs in the last decade utilizing their technology [7] 5. **Financial Performance**: The company operates with an EBITDA margin in the low 30s and is profitable, with ongoing investments in software growth [8] 6. **Market Potential**: Certara estimates a total addressable market (TAM) of approximately $4 billion for biosimulation services, with significant growth opportunities [16] 7. **Regulatory Support**: The FDA has increasingly recognized and approved the use of biosimulation in drug development, with a rise in guidance documents over the years [15] 8. **Shift from Animal Testing**: Recent FDA announcements to phase out animal testing, particularly for monoclonal antibodies, present a favorable environment for Certara's biosimulation models [17][19] 9. **Product Suite**: Certara's offerings include: - **SimShip Simulator**: Models drug kinetics across diverse human populations [22] - **Phoenix**: An analytics tool for fitting clinical trial data to models [28] - **Pinnacle 21**: A data standardization tool used by the FDA for clinical trial submissions [30] - **ChemAxon**: A chemical informatics platform acquired to enhance drug discovery processes [31] 10. **AI Integration**: Certara is incorporating AI into its biosimulation products, enhancing usability and productivity, with AI-related revenue already in the millions [32][33] 11. **Acquisition Strategy**: The company has made strategic acquisitions to bolster its capabilities, including Pinnacle 21, Applied Biomath, and ChemAxon [35] 12. **Growth Strategy**: Certara is focusing on increasing its software revenue, which has a high barrier to entry, while reviewing its services segment for potential restructuring [40][41] Additional Important Insights - **Clinical Trial Efficiency**: Certara's technology has enabled clients to avoid numerous costly clinical trials, demonstrating significant cost savings [26] - **Market Trends**: The increasing adoption of biosimulation in the pharmaceutical industry is reflected in the exponential growth of related publications over the past 25 years [14] - **Regulatory Landscape**: The FDA's evolving stance on biosimulation and data standardization is crucial for the future of drug development and Certara's business model [15][30] This summary encapsulates the critical insights from the conference call, highlighting Certara's role in transforming drug development through innovative technologies and strategic growth initiatives.