Core Insights - Certara, Inc. has launched a new version of the Simcyp™ Simulator, enhancing its capabilities for physiologically-based pharmacokinetic (PBPK) modeling to support data-driven decision-making in drug development [1][2] Company Developments - The Simcyp Simulator Version 24 has been developed with input from a consortium of over 30 leading pharmaceutical companies, reflecting the evolving needs of pharmaceutical collaborators and regulators [2] - The simulator has been instrumental in the approval of over 120 novel drugs by the FDA and has facilitated clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] Technological Advancements - The latest version includes features for predicting food effects on drug absorption, expanded libraries for drug-drug interactions, and improved modeling for special populations such as pediatrics, pregnancy, and lactation [4] - Enhancements in performance and usability include a modernized user interface, cloud computing capabilities, and AI-enabled help chat [4] Market Impact - Currently, 80% of drugs utilizing PBPK for FDA approval in recent years have employed the Simcyp Simulator, indicating its significant role in the industry [2]

Core Insights - Certara, Inc. has released a new version of the Simcyp™ Simulator, enhancing its position as a leader in physiologically-based pharmacokinetic (PBPK) modeling for drug development [1][2] - The latest version, Simcyp Version 24, addresses the evolving needs of pharmaceutical collaborators and regulators, supporting the growing adoption of PBPK in drug development and regulatory decision-making [2] Company Developments - The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs and has supported clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] - A consortium of over 30 leading pharmaceutical companies guides the development of the Simcyp Simulator, ensuring that the latest version incorporates their feedback to enhance capabilities and databases [2] Features of Simcyp Version 24 - The new version includes features for predicting food effects, improving drug absorption simulations under various meal conditions [4] - An expanded library for drug-drug interactions now covers a broader range of capabilities, providing qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney [4] - Enhanced modeling for special populations, including pediatric, pregnancy, and lactation groups, has been incorporated [4] - The user interface has been modernized, and new functionalities such as cloud computing and AI-enabled help chat have been added to improve performance and usability [4]

McKemey joins Certara to accelerate growth of its strategic drug development solutionsRADNOR, Pa., March 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3rd, 2025. In this role, McKemey will lead Certara's global team of drug development scientists. Adrian joins Certara after serving as head of Enterprise Transformation at IQVIA a ...

Financial Data and Key Metrics Changes - Certara reported total revenue of $385.1 million for the full year 2024, representing a 9% increase compared to 2023 [8][30] - Fourth quarter revenue was $100.4 million, reflecting a 14% year-over-year growth [30] - Adjusted EBITDA for the fourth quarter was $33.5 million, up from $29.6 million in the same quarter of 2023, with an adjusted EBITDA margin of 33% [41][42] Business Line Data and Key Metrics Changes - Software revenue for the fourth quarter was $42.3 million, a 26% increase year-over-year, driven by biosimulation software and Pinnacle 21 [32] - Services revenue in the fourth quarter was $58.1 million, up 7% compared to the prior year [36] - Regulatory writing revenue for 2024 was $54.7 million, down from $60.5 million in 2023, indicating a decline in this segment [36] Market Data and Key Metrics Changes - Fourth quarter bookings totaled $144.5 million, a 22% increase from the previous year, with software bookings growing by 38% [9][31] - The software net retention rate was 106% for the fourth quarter and 108% for the full year, consistent with long-term growth profiles [35] Company Strategy and Development Direction - Certara is focused on enabling Model-Informed Drug Development (MIDD) in the biopharmaceutical industry, emphasizing the integration of generative artificial intelligence into existing products [10][14] - The company plans to invest further in software development, particularly for the discovery and lead optimization phases, leveraging Chemaxon's capabilities [21][22] - Certara aims to build an integrated software platform to enhance its competitive positioning in the market [20][22] Management's Comments on Operating Environment and Future Outlook - Management noted that customer sentiment remains cautious due to funding constraints and geopolitical uncertainties, with expectations for 2025 to mirror 2024 in terms of clinical R&D spending [12][13] - The company anticipates total revenue for 2025 to be in the range of $415 million to $425 million, representing growth of 8% to 10% compared to 2024 [46] Other Important Information - Certara expanded its customer base to over 2,400 life sciences companies by the end of 2024, with 431 customers having an annual contract value exceeding $100,000 [18][19] - The company completed the acquisition of Chemaxon in October 2024, which is expected to enhance its capabilities in the discovery biosimulation market [17][26] Q&A Session Summary Question: What drives the 2025 revenue guidance? - Management indicated that the guidance is influenced by spending patterns among Tier 1 and Tier 3 customers, with potential improvements in end markets pushing towards the higher end of the range [55] Question: What are the incremental R&D investments planned for 2025? - The company plans to invest in R&D to maintain momentum in its software portfolio and integrate Chemaxon, which is expected to impact margins [57][58] Question: How is the CoAuthor product performing? - CoAuthor has multiple paying customers and is expected to significantly reduce the time required to create regulatory documents, with revenue expectations in the millions for the year [110][112] Question: What is the outlook for regulatory services? - Regulatory services returned to growth in the fourth quarter, primarily driven by Tier 1 customers, which is expected to positively impact revenue moving into 2025 [106] Question: How does the company view the competitive landscape for Chemaxon? - Chemaxon operates in a fragmented discovery space with unique tools, and the company believes it has a strong competitive position in this area [87]

Certara (CERT) Q4 2024 Earnings Call February 27, 2025 01:59 AM ET Company Participants David Deuchler - Managing DirectorWilliam Feehery - CEOJohn Gallagher - Chief Financial OfficerJeff Garro - Managing DirectorChristine Rains - Healthcare Equity Research AssociateDavid Windley - Managing DirectorConstantine Davides - Managing DirectorAndrew Moss - VP - Equity ResearchKyle Crews - Equity Research AssociateParth Patel - Equity Research Associate Conference Call Participants Michael Cherny - Senior Managing ...

Certara, Inc. (CERT) came out with quarterly earnings of $0.15 per share, beating the Zacks Consensus Estimate of $0.13 per share. This compares to earnings of $0.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.38%. A quarter ago, it was expected that this company would post earnings of $0.11 per share when it actually produced earnings of $0.13, delivering a surprise of 18.18%.Over the last four quarters, the company ha ...

February 26, 2025 © Copyright 2025 Certara, L.P. All rights reserved. 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. Trademarks and Service Marks 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 ...

Financial Performance - Certara Inc. reported total bookings of $445.3 million for the full year 2024, an increase from $402.3 million in 2023[302]. - The company achieved total revenues of $385,148,000 in 2024, representing a 9% growth compared to 2023, with organic revenue growth of 2% amounting to $357,738,000[321]. - Adjusted EBITDA for 2024 was $122,046,000, slightly down from $123,108,000 in 2023 and up from $120,174,000 in 2022[315]. - Adjusted net income for 2024 was $72,871,000, an increase from $69,021,000 in 2023, but a decrease from $73,390,000 in 2022[316]. - The company reported a net loss of $12,051,000 for the year ended December 31, 2024, an improvement of $43.3 million compared to a net loss of $55.4 million in 2023[366]. - Basic net income (loss) per share for 2024 was $(0.08), compared to $(0.35) in 2023, showing improvement[457]. - Operating cash flow for 2024 was $80,466 thousand, slightly down from $82,755 thousand in 2023, and significantly lower than $92,543 thousand in 2022[463]. - Cash and cash equivalents decreased to $179,183,000 in 2024 from $234,951,000 in 2023, a decline of 23.6%[455]. Customer Retention and Growth - The net retention rate for 2024 was 108.8%, compared to 108.4% in 2023, indicating strong customer retention and expansion[303]. - Certara's solutions have contributed to 90% or more of all new drug approvals by the FDA since 2014, showcasing the effectiveness of its biosimulation technology[296]. - The acceptance of model-informed drug development by regulatory authorities is critical for increasing demand for Certara's products and services[305]. Investments and Acquisitions - Certara plans to continue investing in scientific talent, sales and marketing, and research and development to support growth and innovation[304]. - The company has successfully acquired 21 companies since 2013, with significant acquisitions in 2024 including DIDB for $8.3 million[330][335]. - The company completed the acquisition of Chemaxon, Kft. for $96.4 million, resulting in $50.2 million of intangible assets being recorded[440]. Revenue Breakdown - Revenues for the year ended December 31, 2024, increased by $30.8 million, or 9%, to $385.1 million compared to 2023, driven by technology-enabled services and software product offerings[352]. - Software revenue increased by $24.0 million, or 18%, to $155.7 million for the year ended December 31, 2024, primarily due to strong demand from existing customers and business acquisitions[353]. - Services revenue increased by $6.8 million, or 3%, to $229.5 million for the year ended December 31, 2024, attributed to growth from business acquisitions and technology-enabled services[354]. Operating Expenses - Certara's operating expenses are expected to increase over time as the company expands its solutions and workforce[304]. - Sales and marketing expenses rose by $15.4 million, or 48%, to $47.4 million for the year ended December 31, 2024, driven by headcount growth and increased commission expenses[357]. - Research and development expenses increased by $2.9 million, or 9%, to $37.1 million for the year ended December 31, 2024, primarily due to headcount growth associated with software development investments[358]. - General and administrative expenses decreased by $1.2 million, or 1%, to $94.2 million for the year ended December 31, 2024, mainly due to a decrease in contingent consideration fair value[359]. Tax and Deferred Assets - The company expects income tax expense to increase over time as it continues to grow more profitable[329]. - The company has federal and state net operating losses (NOLs) of approximately $6.2 million and $4.9 million, respectively, which are available to reduce future taxable income[386]. - A valuation allowance of $24 million was recorded as of December 31, 2024, indicating that it is more likely than not that the company will not realize the benefits of certain deferred tax assets[387]. Cash Flow and Financing - Net cash provided by operating activities was $80.5 million for the year ended December 31, 2024, a decrease from $82.8 million in 2023[370]. - Net cash used in investing activities increased to approximately $112.4 million for the year ended December 31, 2024, primarily due to higher cash payments for business acquisitions[377]. - As of December 31, 2024, the company had $298.5 million of outstanding borrowings on the term loan and $100.0 million available under the revolving credit facility[380]. International Operations - 28% of the company's revenue for the year ended December 31, 2024, was derived from international operations[415]. - The company operates in multiple countries, including the United States, Canada, and several European nations, enhancing its global market presence[465].

Revenue Performance - Full-Year 2024 revenue reached $384.4 million, an increase of 8% compared to $354.3 million in 2023[6] - Fourth Quarter 2024 revenue was $99.7 million, representing a growth of 13% from $88.0 million in the fourth quarter of 2023[6] - Software revenue for Full-Year 2024 was $155.0 million, an 18% increase from $131.7 million in 2023[6] - Services revenue for Full-Year 2024 was $229.4 million, a growth of 3% compared to $222.7 million in 2023[6] - The acquisition of Chemaxon contributed $5.9 million in revenue and $11.0 million in bookings[6] Bookings Performance - Bookings for Full-Year 2024 totaled $445.3 million, up 11% from $402.3 million in 2023[6] - Fourth Quarter 2024 bookings were $144.5 million, reflecting a growth of 22% compared to $118.9 million in the fourth quarter of 2023[6] - Software bookings for Full-Year 2024 were $169.4 million, representing a growth of 24% from $136.9 million in 2023[6] - Services bookings for Full-Year 2024 were $275.9 million, a 4% increase from $265.4 million in 2023[6] Financial Expectations - Adjusted EBITDA for Full-Year 2024 is expected to be between $120 million and $124 million[4]

Core Insights - Certara, Inc. reported strong financial results for Q4 2024, with total revenue of $100.4 million, reflecting a year-over-year growth of 14% [4][8] - The company is optimistic about its investment strategy in software and AI, aiming to enhance its biosimulation offerings and capitalize on the growing interest in biosimulation technology within the biopharmaceutical industry [3][4] - Certara provided guidance for 2025, expecting revenue between $415 million and $425 million, with adjusted EBITDA margins in the range of 30-32% [16] Financial Performance - Total revenue for Q4 2024 was $100.4 million, up from $88.0 million in Q4 2023, marking a 14% increase [4][8] - Software revenue reached $42.3 million, a 26% increase from $33.6 million in Q4 2023, driven by growth in biosimulation software [5][8] - Services revenue was $58.1 million, up 7% from $54.4 million in Q4 2023, primarily due to demand for biosimulation services [5][8] Bookings and Growth - Total bookings for Q4 2024 were $144.5 million, representing a 22% year-over-year growth [6][8] - Software bookings increased by 38% to $59.7 million, attributed to strong performance in Certara's core biosimulation software [6][8] - Services bookings grew by 12% to $84.8 million, driven by increased demand for biosimulation and regulatory services [7][8] Profitability Metrics - Net income for Q4 2024 was $6.6 million, compared to a net loss of $12.5 million in Q4 2023 [12][11] - Adjusted EBITDA for Q4 2024 was $33.5 million, a 13% increase from $29.6 million in Q4 2023 [11][12] - Adjusted net income for Q4 2024 was $24.7 million, up from $14.3 million in Q4 2023, with adjusted diluted earnings per share of $0.15 compared to $0.09 in the prior year [13][11] Cost and Expense Management - Total cost of revenue for Q4 2024 was $38.3 million, an increase from $34.1 million in Q4 2023, mainly due to higher employee-related expenses and software amortization [9][8] - Total operating expenses decreased to $56.1 million from $62.4 million in Q4 2023, primarily due to a reduction in the change in fair value of contingent consideration [10][8] 2025 Financial Outlook - Certara expects full-year 2025 revenue to be in the range of $415 million to $425 million [16] - The company anticipates adjusted EBITDA margins to remain in the low thirties for 2025 [3][16] - Adjusted diluted earnings per share for 2025 is projected to be between $0.42 and $0.46 [16]