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.

Summary of Certara (CERT) 2025 Conference Call Company Overview - Certara is a software and services company specializing in biosimulation and model-informed drug development, with approximately 45% of its business derived from software and the remaining from services [3][4] Key Financial Performance - The company performed in line with expectations in Q1, with software aided by the acquisition of Chemaxon in Q4 of the previous year [3][4] - The services business also met expectations, showing mid-single-digit growth, supported by a return to growth in regulatory services [3][4] Industry Dynamics - The FDA's recent announcement to reduce animal testing requirements positions Certara favorably, as it aligns with their existing products and services [5][6] - The directive is expected to drive incremental revenue, particularly in their SIMSIP and QSP product areas [6][22] Customer Engagement - Certara maintains a strong relationship with the FDA, which is a significant user of their software, and they continue to engage in constructive dialogue [8][9] - The company aims to deepen penetration within large pharmaceutical companies, focusing on expanding their footprint into the preclinical stage of drug development [10][11] Challenges and Opportunities - Tier three customers (biotechs) are facing a challenging funding environment, which could impact growth despite strong Q1 performance [13][14] - Certara is investing in R&D and enhancing AI capabilities to improve their software offerings, including the recent launch of Co Author for regulatory writing [16][19] Product Development - The Non-Animal Navigator was launched in response to the FDA's directive, aimed at helping customers transition away from animal testing [21][23] - The integration of Chemaxon is expected to expand Certara's capabilities into the discovery phase of drug development, enhancing their overall service offerings [27][28] Market Outlook - The company anticipates continued challenges in the end market environment, particularly with tier one customers, but remains optimistic about growth opportunities stemming from the FDA directive [52][53] - Certara's capital allocation strategy includes a focus on M&A to enhance their software capabilities, with a goal to increase the software revenue mix from 45% to 50% by year-end [48][49] Conclusion - Certara is well-positioned to capitalize on regulatory changes and expand its market presence through strategic investments and product development, despite facing headwinds in the biotech funding environment [52][53]

First Quarter 2025 Financial Results May 5, 2025 Disclaimer The Certara design logo, "Certara," and our other registered or common law trademarks, service marks or trade names appearing in this presentation are our property. Solely for convenience, our trademarks, tradenames, and service marks referred to in this presentation appear without the registered mark or trademark symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable ...

Certara, Inc. (CERT) came out with quarterly earnings of $0.14 per share, beating the Zacks Consensus Estimate of $0.13 per share. This compares to earnings of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 7.69%. A quarter ago, it was expected that this company would post earnings of $0.13 per share when it actually produced earnings of $0.15, delivering a surprise of 15.38%.Over the last four quarters, the company has ...

Certara (CERT) Q1 2025 Earnings Call May 05, 2025 05:00 PM ET Company Participants David Deuchler - IRWilliam Feehery - CEOJohn Gallagher - Chief Financial OfficerDaniel Clark - VP - Equity ResearchScott Schoenhaus - Managing DirectorDavid Windley - Managing DirectorJeff Garro - Managing DirectorChristine Rains - Healthcare Equity Research AssociateConstantine Davides - Managing DirectorJacqueline Kisa - Equity Research AssociateParth Patel - Equity Research Associate Conference Call Participants Joe Vruwin ...

Certara (CERT) Q1 2025 Earnings Call May 05, 2025 05:00 PM ET Speaker0 Good day and thank you for standing by. Welcome to the Certara First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, Pl ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-39799 Certara, Inc. (Exact name of registrant as specified in its charter) (Sta ...

Revenue Projections - Preliminary revenue for Q1 2025 is expected to be $106.0 million, a 10% increase from $96.7 million in Q1 2024[5] - Software revenue for Q1 2025 is projected at $46.4 million, reflecting an 18% growth compared to $39.3 million in Q1 2024[5] - Services revenue for Q1 2025 is anticipated to be $59.6 million, representing a 4% increase from $57.3 million in Q1 2024[5] - Full-year 2025 revenue guidance is reiterated to be between $415 million and $425 million[12] Bookings and Growth - Bookings for Q1 2025 are expected to reach $118.0 million, a 12% growth from $105.8 million in Q1 2024[5] - Adjusted EBITDA for Q1 2025 is projected to be in the range of $33-$35 million, indicating a growth of 13-20% from $29.1 million in Q1 2024[5] - Full-year adjusted EBITDA margin is expected to be in the range of 30-32%[12] Earnings and Shareholder Returns - Full-year adjusted diluted earnings per share is anticipated to be between $0.42 and $0.46[12] - The company has authorized a stock repurchase program of up to $100 million[2] Shareholder Agreements - Arsenal Capital Partners has agreed to a one-year lock-up on shares acquired in a December 2022 transaction[3]

Reiterates Full Year 2025 Financial GuidanceRADNOR, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the first quarter of fiscal year 2025. First Quarter Highlights: Revenue was $106.0 million, compared to $96.7 million in the first quarter of 2024, representing growth of 10%. Software revenue was $46.4 million, compared to $39.3 million in the first quarter of 2024, representing growth of 18%.Ser ...

Certara, Inc. (CERT) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 5. On ...