Core Insights - Certara, Inc. has achieved significant recognition in 2024 with over 100 publications and 12 scientists listed among the top 2% of most cited researchers globally [1][2][3] Group 1: Company Achievements - Certara's scientists have been recognized for their contributions to drug development, with 12 researchers making it to the Stanford/Elsevier list of top-cited scientists [2][3] - The company emphasizes its science-driven approach, providing advanced biosimulation software and expert advice to clients for strategic decision-making [3] Group 2: Publications and Research Focus - In 2024, Certara's publications cover the entire drug discovery and development process, highlighting key trends in areas such as pediatric oncology, mechanistic modeling, and the use of real-world data [4][5] - Notable topics include the impact of physiologically-based pharmacokinetics (PBPK) modeling on global health and the role of pharmacometrics in clinical trials [5] Group 3: Client Base and Services - Certara serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries, showcasing its global reach and influence in the industry [6]

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $94.8 million, representing an 11% year-over-year increase, while total bookings were $96.1 million, up 13% [8][31] - Software revenue reached $35.9 million, a 15% increase year-over-year, with software bookings at $34.8 million, up 28% [31][32] - Adjusted EBITDA for Q3 2024 was $33.1 million, an increase from $28.8 million in Q3 2023, with an adjusted EBITDA margin of 35% [39] Business Line Data and Key Metrics Changes - Biosimulation services saw higher utilization, contributing to improved EBITDA margins, while regulatory services faced challenges with a divergence in growth profiles [10][11][35] - Services revenue was $58.9 million, a 9% increase year-over-year, with technology-driven services bookings at $61.3 million, up 6% [33][34] Market Data and Key Metrics Changes - Among Tier 1 biopharma customers, there was stability and some improvement in new business activity, while Tier 3 customers continued to grow due to an improved funding environment [8][10] - The regulatory services market experienced a lengthened decision-making process among larger customers, impacting growth expectations [11][12] Company Strategy and Development Direction - The company is focused on expanding its biosimulation capabilities and integrating Chemaxon to enhance its product offerings [9][18] - Certara aims to create a unified platform through Certara Cloud, which will lower IT costs and improve customer engagement [17][49] - A review process for long-term strategic options regarding the regulatory services business has been initiated, reflecting a divergence from the core biosimulation business [12][80] Management's Comments on Operating Environment and Future Outlook - Management noted a cautious outlook for second-half growth due to a lengthened decision-making process among larger customers and challenges in the regulatory services market [11][62] - The company remains optimistic about its biosimulation demand, citing a strong pipeline and high win rates [10][25] Other Important Information - The acquisition of Chemaxon was completed in early October, expected to contribute approximately $5 million in revenue for Q4 2024 [41][53] - The company updated its 2024 guidance, expecting total revenue between $380 million and $385 million, reflecting a growth of 7% to 9% compared to 2023 [42] Q&A Session Summary Question: Demand environment for biosimulation and budget flush activity - Management indicated that there is a traditional budget flush in Q4, but they did not count on it in their guidance [46] Question: Impact of Certara Cloud on customer interactions - Certara Cloud is facilitating easier access to products and lowering IT costs, which is positively impacting software bookings [49][50] Question: Chemaxon acquisition revenue expectations - Expected revenue from Chemaxon in Q4 is about $5 million, primarily from software [53] Question: Regulatory services business size and potential divestiture - The regulatory services business is expected to generate $50 million to $55 million in revenue, with margins comparable to traditional CROs [57] Question: Improvements with Tier 1 customers - There was stability and some improvement in Tier 1 customer performance from Q2 to Q3, particularly in biosimulation services [59] Question: Demand from Tier 1 clients and smaller biotech customers - The sales pipeline is healthy, but there is a noted lengthening of time to close projects, indicating some hesitancy among larger customers [61][62] Question: Resource reallocation from services to software - The company is seeing strong performance in software, with a net retention rate of 110%, while biosimulation services are also performing well [66] Question: Uniqueness and demand for biosimulation - Demand is driven by sustained investment in biosimulation products and acceptance by regulatory agencies, making it a cost-effective alternative to clinical trials [70][72]

Financial Performance - Revenues for the three months ended September 30, 2024, increased to $94.82 million, up 10.3% from $85.58 million in the same period of 2023[16] - Net loss for the three months ended September 30, 2024, was $1.37 million, compared to a net loss of $48.97 million for the same period in 2023[16] - Total operating expenses for the three months ended September 30, 2024, decreased to $55.04 million, down 46.3% from $102.48 million in the prior year[16] - The company reported a basic net loss per share of $0.01 for the three months ended September 30, 2024, compared to a loss of $0.31 per share in the same period of 2023[16] - Net loss for the nine months ended September 30, 2024, was $18,628,000, compared to a net loss of $42,901,000 for the same period in 2023, representing a 56.5% improvement[21] - Adjusted EBITDA for Q3 2024 was $33.1 million, up from $28.8 million in Q3 2023[169] - Adjusted net income for Q3 2024 was $20.3 million, compared to $17.1 million in Q3 2023[171] Cash and Assets - Cash and cash equivalents as of September 30, 2024, were $233.02 million, slightly down from $234.95 million as of December 31, 2023[15] - Total assets as of September 30, 2024, were $1.54 billion, a decrease from $1.56 billion as of December 31, 2023[15] - Accounts receivable increased to $95.96 million as of September 30, 2024, compared to $84.86 million as of December 31, 2023[15] - The company’s total liabilities decreased to $489.82 million as of September 30, 2024, from $516.30 million as of December 31, 2023[15] - Stockholders' equity increased to $1.05 billion as of September 30, 2024, compared to $1.05 billion as of December 31, 2023[15] - Total assets as of September 30, 2024, amounted to $153,102 thousand, with money market funds at $147,478 thousand and interest rate swap assets at $5,624 thousand[42] Expenses and Liabilities - Common shares issued for employee share-based compensation totaled 1,297,519, with a corresponding expense of $27,043,000[19] - The accumulated deficit as of September 30, 2024, was $(134,858,000), an increase from $(116,230,000) as of December 31, 2023[17] - The additional paid-in capital increased to $1,209,196,000 as of September 30, 2024, from $1,178,461,000 as of December 31, 2023[17] - Total liabilities as of September 30, 2024, were $54,457 thousand, consisting solely of contingent liabilities related to acquisitions[42] - Total accrued expenses decreased to $53,294 thousand as of September 30, 2024, down from $56,779 thousand, a reduction of 6.9%[105] Acquisitions and Growth - The Company completed 20 acquisitions since 2013, with 13 involving software or technology[78] - The acquisition of Drug Interaction Solutions from the University of Washington was completed for a total consideration of $8,340,000[79] - The acquisition of Formedix was completed for an estimated consideration of $41,389,000, with contingent consideration not to exceed $9,000,000[82] - The acquisition of Applied BioMath, LLC was completed for an estimated consideration of $36,594,000, with contingent consideration not to exceed $17,550,000[85] - The company completed the acquisition of Chemaxon on October 1, 2024, for a total cash consideration of $90,000 thousand[139] Revenue Breakdown - Total revenue for the nine months ended September 30, 2024, was $284,787,000, representing a 6.5% increase from $266,327,000 in the same period of 2023[72] - Software licenses transferred at a point in time generated $10,202,000 in revenue for 2024, compared to $9,916,000 in 2023, marking a 2.9% increase[72] - Service revenues earned over time increased to $58,908,000 in 2024 from $54,246,000 in 2023, reflecting an increase of 10.0%[72] - Software revenues increased by $4.6 million, or 15%, to $35.9 million for the three months ended September 30, 2024, driven by strong demand from existing customers and business acquisitions[202] - Services revenues increased by $4.7 million, or 9%, to $58.9 million for the three months ended September 30, 2024, attributed to growth from business acquisitions and technology-enabled services[203] Operating Expenses - Sales and marketing expenses increased by $4.1 million, or 57%, to $11.3 million for the three months ended September 30, 2024, mainly due to headcount growth and increased commission expenses[204] - General and administrative expenses decreased by $5.7 million, or 21%, to $22.0 million for the three months ended September 30, 2024, compared to the same period in 2023[206] - Research and development expenses for the nine months ended September 30, 2024, totaled $29.33 million, up from $26.16 million in the prior year[16] - Research and development expenses decreased by $0.7 million, or 8%, to $8.3 million for the three months ended September 30, 2024, primarily due to an increase in capitalized costs in R&D[205] Market and Competition - The company has operations in multiple countries, including the United States, Australia, and Germany, indicating a broad market presence[24] - Regulatory acceptance of biosimulation is increasing, positively impacting demand for the company's products and services[159] - The company faces competition in the biosimulation market, with key factors including model quality and regulatory acceptance[161] Tax and Interest - The effective tax rate for the three months ended September 30, 2024, was 17%, compared to 9% for the same period in 2023[135] - Interest incurred on the Credit Agreement for the term loan amounted to $19,900,000 for the nine months ended September 30, 2024[96] - Interest expense decreased by $0.7 million, or 12%, to $5.2 million for the three months ended September 30, 2024, compared to the same period in 2023[210]

Exhibit 99.1 Certara Reports Third Quarter 2024 Financial Results Updates Full Year 2024 Financial Guidance RADNOR, PA — November 6, 2024-- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the third quarter of fiscal year 2024. Third Quarter Highlights: • Revenue was $94.8 million, compared to $85.6 million in the third quarter of 2023, representing growth of 11%. • Software revenue was $35.9 million, compared to $31.3 million in the ...

RADNOR, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the third quarter of fiscal year 2024. Third Quarter Highlights: Revenue was $94.8 million, compared to $85.6 million in the third quarter of 2023, representing growth of 11%. Software revenue was $35.9 million, compared to $31.3 million in the third quarter of 2023, representing growth of 15%.Services revenue was $58.9 million, compared to ...

RADNOR, Pa., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that Company management will participate in the Stephens Annual Investment Conference. Company management will present at 10:00AM CT on Thursday, November 21st, 2024. A live webcast of the event will be available on Certara's investor relations website at https://ir.certara.com and will be available for replay for at least 90 days thereafter. About Certara Certara ...

RADNOR, Pa., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of John Reynders, PhD, to its Board of Directors, effective October 15, 2024. "We are excited to welcome an accomplished pharmaceutical industry leader with a track record of success to Certara's Board," said William F. Feehery, PhD, CEO of Certara. "John's expertise in artificial intelligence, data science, and life science will provide immense val ...

RADNOR, Pa., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced that it will release financial results for the third quarter of 2024 after the market close on Wednesday, November 6th, 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening to the conference call are required to register online. It is recommended to register at least one day in advance. A ...

RADNOR, Pa., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced it has completed the acquisition of Chemaxon. Chemaxon develops leading scientific informatics software products used by the life sciences industry for insilico research. Certara develops advanced modeling and biosimulation solutions used to predict the pharmacokinetic and pharmacodynamic properties of large and small molecules. "Combining Chemaxon's expertise with ...

RADNOR, Pa., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today shared the results from its collaboration with Ichnos Glenmark Innovation (IGI) on the first-in-human dose prediction and selection for ISB 2001. IGI's drug candidate is a trispecific T-cell engager (TCE) being studied as a potential cancer treatment. Preclinical research and biosimulation findings were recently published in Nature Cancer. This publication highlighted ISB 2 ...