Question-and-Answer SessionUnder the bright lights here. So I guess to start off, can you just recap how the quarter from 4Q shook out versus what you guys were expecting? And this is more of just thinking about a jump-off point from kind of the lumpiness and the softer demand that we saw through '25. And how the first quarter as you guys are looking at it within your assumption there throughout '26 is going to progress, like puts and takes as you thought about it?John GallagherSVP, Principal Accounting Off ...

Summary of Certara FY Conference Call (March 10, 2026) Company Overview - **Company**: Certara (NasdaqGS:CERT) - **Industry**: Life Science Tools and Diagnostics Key Financial Performance - **Revenue**: Organic software revenue for FY 2025 was 7%, within the guidance range of 6%-8% [5] - **EBITDA Margin**: Achieved 32%, exceeding the guidance of 30%-32% [5] - **Bookings**: Mixed performance in Q4; December saw a strong 17% increase in services bookings [6][7] - **Software Bookings**: Trailing twelve-month organic software bookings were only 1%, indicating a decline year-on-year in Q4 [7][8] Market Dynamics - **Customer Behavior**: Notable reduction in seat licenses from tier one customers due to headcount reductions in Big Pharma [14][15] - **Study Counts**: Decreased clinical trial starts 18-24 months prior affected software bookings, particularly for the Pinnacle 21 platform [15][16] - **Seasonality**: Q4 showed strong discretionary spending, but services bookings remain lumpy historically [6][7] 2026 Guidance and Expectations - **Revenue Growth**: Expected to be flat to up 4% for 2026, with Q1 anticipated to be on the lower end of the guidance range [8][20] - **New Product Launches**: Three new software products launched in Q4, including Certara IQ for QSP and Phoenix Cloud, expected to drive growth [22][30] Product Development and AI Integration - **Certara IQ**: AI-enabled software for quantitative systems pharmacology (QSP), aimed at enhancing internal project throughput and customer sales [28][30] - **Phoenix Cloud**: Cloud version of the Phoenix platform, designed to transition customers from desktop to cloud, with positive initial reception [32][35] - **AI as Competitive Advantage**: Integration of AI technology from Vyasa is seen as a unique opportunity to enhance software offerings and maintain customer reliance [42][44] Regulatory Services and Strategic Evaluation - **Regulatory Writing Business**: High profit margins (20%-30%) but facing revenue declines; under evaluation for potential sale or retention [58][61] - **CEO's Focus**: New CEO Jon Resnick is assessing the regulatory business's status and its impact on shareholder value [55][57] Investment and Growth Strategy - **Customer-Centric Approach**: Emphasis on unifying software and services to better meet customer needs and enhance value proposition [72][73] - **Rule of Forty**: Company aims to align with the rule of forty, currently slightly below due to investments impacting margins [79][80] - **Cost Management**: Identified $10 million in cost avoidance opportunities while maintaining disciplined spending [83][85] Conclusion - Certara is navigating a transitional phase with mixed financial performance, focusing on new product launches and AI integration to drive future growth while evaluating its regulatory services segment for strategic decisions.

Question-and-Answer SessionSo let's just jump in. I mean, so you just reported and you had some interesting moving pieces, I would say, on your guidance and the outlook for '26. Can you talk a little bit about some of the assumptions that you have embedded both in terms of where you see the market right now and where you see Certara's execution within your client base?John GallagherSVP, Principal Accounting Officer & Chief Financial Officer Yes, sure. So we did. So we just reported on the -- at the end of F ...

Certara (NasdaqGS:CERT) 2026 Conference March 09, 2026 08:00 AM ET Company ParticipantsJohn Gallagher III - CFOConference Call ParticipantsMike Cherny - Senior Research Analyst of Healthcare Technology and DistributionMike ChernyGreat. Good morning, everyone. Welcome to the first session of the Leerink Partners global healthcare conference. I'm Mike Cherny, the Healthcare Tech and Distribution Analyst. It's my pleasure to have with us Certara, John E. Gallagher III, our CFO, David Deuchler, does IR, sitting ...

Certara (NasdaqGS:CERT) 2026 Conference March 09, 2026 08:00 AM ET Company ParticipantsJohn Gallagher - CFOMike Cherney - Senior Managing Director, Healthcare Technology and DistributionMike CherneyOkay. I think we're ready. Are we good or? Yeah. Okay. Great. Good morning, everyone. Welcome to the first session of Leerink Partners Global Healthcare Conference. I'm Mike Cherney, the healthcare tech and distribution analyst. It's my pleasure to have with us Certara, John Gallagher, our CFO, David Deichler, do ...

Core Insights - The 42nd Annual TD Cowen Healthcare Conference features a discussion with Certara's management team, including CEO Jon Resnick, who recently took on the role on January 1 of this year [1][2]. Group 1 - The conference serves as a platform for Certara to engage with investors and analysts, highlighting the importance of communication in the healthcare sector [1][2]. - Jon Resnick is expected to provide an overview of the company's performance and insights from the recent financial report released last week [3].

Summary of Certara FY Conference Call (March 03, 2026) Company Overview - **Company**: Certara (NasdaqGS:CERT) - **Industry**: Biotechnology and Pharmaceutical Services Key Points and Arguments Leadership Transition - John Gallagher, the new CFO, has been in the role for approximately 61-62 days and is focused on transitioning from fact-finding to actionable solutions for business growth [7][8][9] - The management team expresses optimism about the company's potential and the quality of its products and personnel [8][9] Growth Drivers - Certara has several market-leading products with growth potential, particularly in the MIDD (Model-Informed Drug Development) and Biosimulation sectors, which constitute about two-thirds of the business [12][13] - The company aims to enhance operational execution and customer-centricity, focusing on strategic clarity and disciplined product management [14][15] Regulatory Services Business - There is ongoing discussion about the future of the Regulatory services business, with mixed opinions on whether to sell or retain it. The business has shown resilience despite market pressures [17][19][22] - The CFO noted a 1.5 book-to-bill ratio in December, indicating strong performance despite external pressures [18][19] Financial Outlook - For FY 2026, Certara expects flat to 4% growth in top-line revenues, with low single-digit growth anticipated for both software and services [32][34][36] - The company reported a strong EBITDA margin of 32% for the previous year and aims to maintain similar margins despite increased investments in growth areas [46][48] AI Integration and Innovation - Certara is embedding AI capabilities into its existing products, such as Phoenix Cloud and Certara IQ, which are expected to drive growth in the near term [50][52] - The company anticipates that AI will enhance both technology and service offerings, with a focus on customer adoption and integration [54][55] Regulatory Relationships - Certara has established strong relationships with over 20 regulators globally, which aids in facilitating communication between biopharma customers and regulatory bodies [30][31] - The company is optimistic about the positive regulatory environment and its potential to drive business growth [30] Future Catalysts - Key growth catalysts include the transition of tier 1 customers to the cloud version of Phoenix and developments in QSP (Quantitative Systems Pharmacology) [61][62] - Certara is exploring new metrics to better communicate its growth and value beyond traditional service versus software bookings [63][64] Additional Important Insights - The management emphasizes the importance of innovation and operational changes to leverage external partnerships effectively [58] - The company is focused on understanding customer needs and enhancing its offerings to meet those demands [56][57] This summary encapsulates the critical insights from the Certara FY Conference Call, highlighting the company's strategic direction, financial outlook, and growth opportunities within the biotechnology and pharmaceutical services industry.

Core Insights - Certara, Inc. announced that its Simcyp Simulator's physiologically-based pharmacokinetic (PBPK) modeling predictions were accepted by the U.S. FDA to support the new drug application (NDA) for asciminib, demonstrating the effectiveness of model-informed drug development approaches in regulatory decision-making [1][2] Group 1: Drug Development and Regulatory Impact - PBPK modeling utilizes virtual biological systems to predict drug absorption, distribution, metabolism, and elimination, increasingly replacing certain clinical studies [1] - The results from the PBPK modeling for asciminib provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA process [2] - The collaboration on asciminib's modeling evolved over a decade, enhancing understanding of its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval [3] Group 2: Asciminib and Chronic Myeloid Leukemia (CML) - Asciminib is a first-in-class allosteric inhibitor targeting the BCR::ABL1 myristoyl pocket, used for treating Chronic Myeloid Leukemia (CML) [2] - The global incidence rate of CML was approximately one case per 100,000 population in 2018, accounting for about 15% of newly diagnosed leukemia cases in adults [2] - PBPK modeling enabled a mechanistic assessment of asciminib's pharmacokinetics across diverse patient populations and dosing regimens [2] Group 3: Company Overview - Certara accelerates medicine development using biosimulation software and services, serving over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [4]

Core Viewpoint - Certara Inc. is a significant entity in the Medical - Biomedical and Genetics industry, focusing on software and services that expedite drug development. The company has received an "Outperform" rating from Leerink Partners, indicating a positive outlook for investors [1][5]. Financial Performance - The recent earnings report indicated a quarterly earnings per share (EPS) of $0.09, which was below the Zacks Consensus Estimate of $0.11, resulting in a negative surprise of 20.57%. This EPS also represents a decline from $0.15 in the same quarter last year [2][5]. - Certara reported quarterly revenue of $103.65 million for the period ending December 2025, slightly exceeding the Zacks Consensus Estimate by 0.41%. This revenue reflects an increase from $100.36 million reported in the same quarter of the previous year [3][5]. Stock Performance - Certara's stock is currently trading at $6.61, showing a minor increase of 0.23% or $0.015. The stock has fluctuated between a low of $6.04 and a high of $6.66 on the same day. Over the past year, the stock reached a high of $15.38 and a low of $6.04 [4]. - The company has a market capitalization of approximately $1.05 billion, with a trading volume of 2,780,555 shares [4].

Resnick argued Certara’s tools and scientific teams are positioned to benefit from those trends, citing the company’s 430 PhDs and MDs, more than 2,600 customers, and 23 agencies using its technologies. At the same time, he said the company has not converted its credibility into growth commensurate with the opportunity, and he pointed to a mix of factors that could explain the gap, including market acceptance, external headwinds, and internal execution issues.Resnick, who joined the company on Jan. 1, said ...