Certara, Inc. is a global leader in biosimulation and model-informed drug development. The company provides software products and technology-driven services that help optimize drug discovery, preclinical and clinical research, regulatory submissions, and market access. Certara's offerings are designed to accelerate drug development programs, reduce costs, and increase the probability of success for its customers.
- Services - Offers technology-enabled services that streamline clinical trials and regulatory submissions, enhancing drug development efficiency and success rates.
- Software - Provides biosimulation software that supports predictive modeling and simulation, facilitating efficient drug development and regulatory compliance.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
John E. Gallagher III Executive | Senior Vice President and Chief Financial Officer | John E. Gallagher III has served as Certara's Senior Vice President and Chief Financial Officer since April 1, 2023. He is a seasoned finance leader with prior experience as CFO at Cue Health and in various executive roles at BD and other companies. | ||
Leif E. Pedersen Executive | President, Chief Commercial Officer | Leif E. Pedersen is the President, Chief Commercial Officer at Certara since August 2023, and previously served as President of Software from September 2020 to August 2023. | ||
Robert P. Aspbury Executive | President of Certara Scientific Software | Robert P. Aspbury has served as President of Certara Scientific Software since January 2020. He previously served as the Chief Operating Officer of the Simcyp Division from April 2019 to December 2019. | ||
David Spaight Board | Class I Director | Operating Partner at Arsenal Capital Partners | David Spaight was appointed as a Class I Director at CERT on December 8, 2022 and serves on the Compensation Committee with a term expiring at the 2024 Annual Meeting of Shareholders. He has over 35 years of experience in the life sciences industry, having held leadership roles at organizations such as Arsenal Capital Partners, WIL Research Laboratories, and MDS Pharma Services. | |
Eran Broshy Board | Director | Board Member at Theravance Biopharma, Inc.; Board Member at Thirty Madison | Eran Broshy serves as Director and Chair of the Nominating and Corporate Governance Committee at Certara since July 2022. He also holds active board roles at Theravance Biopharma, Inc. and Thirty Madison, underscoring his extensive leadership experience. | |
Matthew Walsh Board | Director | Executive Vice President and Chief Financial Officer at Organon & Co. | Matthew Walsh is a Director at CERT since August 2020 and serves as the Chair of the Audit Committee. He has extensive experience in senior financial roles, including his current role as Executive Vice President and Chief Financial Officer at Organon & Co. since June 2020. | |
Rosemary Crane Board | Class III director | Current Board Member at Tarsus Pharmaceuticals, Inc.; Current Board Member at Teva Pharmaceutical Industries Limited | Rosemary Crane is a Class III director at Certara since July 21, 2022. She brings extensive pharmaceutical and board expertise, with active roles as a Current Board Member at Tarsus Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Limited. |
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Given that adjusted EBITDA margins are expected to decline in 2025 due to increased R&D investments and the integration of Chemaxon, can you provide more clarity on the timeline for when margins will return to previous levels and what specific milestones need to be achieved to realize these margin improvements?
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With the integration of Chemaxon underway, can you elaborate on the challenges you're facing in aligning Chemaxon's lower margins with Certara's margins, and what steps are being taken to ensure the acquisition contributes positively to earnings in the near term?
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The software net retention rate declined to 106% in Q4, down from 108% for the full year, partly due to spending patterns of Tier 1 customers; does this indicate a potential trend of decreased software adoption among large pharma clients, and how do you plan to address this issue?
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You mentioned cautious spending behavior among customers and elongated decision-making timelines; given this, are the revenue growth assumptions of 8–10% for 2025 realistic, and what gives you confidence in achieving this guidance despite ongoing market headwinds?
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Regarding the strategic review of the regulatory writing business, can you provide any insights into the potential outcomes being considered, and how a decision to divest or restructure this segment would impact Certara's overall growth strategy and financial performance?
Research analysts who have asked questions during Certara earnings calls.
Jeffrey Garro
Stephens Inc.
3 questions for CERT
Kyle Crews
UBS
3 questions for CERT
Christine Rains
William Blair
2 questions for CERT
Constantine Davides
Citizens JMP
2 questions for CERT
David Windley
Jefferies Financial Group Inc.
2 questions for CERT
Max Smock
William Blair & Company
2 questions for CERT
Ahmed Muhammad Rahat
Leerink Partners
1 question for CERT
Andrew Moss
Bank of America
1 question for CERT
Anna Kruszenski
Barclays
1 question for CERT
Avantika Dhabaria
BofA Securities
1 question for CERT
Brendan Smith
Stifel, Nicolaus & Company, Incorporated
1 question for CERT
Charles Scholes
Not Disclosed
1 question for CERT
Daniel Clark
Leerink Partners
1 question for CERT
Dave Windley
Jefferies LLC
1 question for CERT
Jeff Garro
Stephens Inc.
1 question for CERT
Joe Vruwink
Baird
1 question for CERT
Joseph Vruwink
Baird
1 question for CERT
Luke Sergott
Barclays
1 question for CERT
Michael Cherny
Leerink Partners
1 question for CERT
Morgan Gryga
Morgan Stanley
1 question for CERT
Scott Schoenhaus
KeyBanc Capital Markets
1 question for CERT
Steve Dechert
KeyBanc Capital Markets
1 question for CERT
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Mathworks | Competes in the biosimulation software market, offering technology solutions that vary in size, capabilities, and breadth. |
Dassault Systemes | Provides technology solutions in the biosimulation software market, competing on functionality, quality, and regulatory acceptance. |
Operates in the biosimulation software market, competing on ease of use, functionality, and integration capabilities. | |
A competitor in the biosimulation software market, focusing on molecular types, therapeutic areas, and modalities supported. | |
NONMEM (a division of ICON) | Offers biosimulation software solutions and competes on scientific, technical, and regulatory expertise. |
R | An open-source solution competing in the biosimulation software market, providing free software and intellectual property. |
PK-Sim | An open-source biosimulation software solution competing with proprietary offerings. |
Metrum Research | Specialized service provider competing in technology-enabled services, focusing on drug development expertise. |
qPharmetra | Competes in technology-enabled services, offering specialized expertise in drug development. |
Pharmetheus | A specialized service provider competing in technology-enabled services, focusing on scientific and regulatory expertise. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Chemaxon | 2024 | Certara acquired Chemaxon with a total cash consideration of $90 million, announced on July 9, 2024 and closed on October 1, 2024, to enhance its drug discovery offerings by integrating Chemaxon’s leading cheminformatics software with its biosimulation, AI technology, and Certara Cloud. |
Formedix Limited | 2023 | Certara acquired Formedix Limited on October 10, 2023 for up to $39 million (comprising $30 million in cash and up to $9 million in deferred contingent consideration), adding clinical metadata repository and clinical trial automation capabilities to its portfolio. |
Drug Interaction Solutions (DIDB) | 2023 | Completed on June 20, 2023, the acquisition of DIDB from the University of Washington involved a total consideration of $8.3 million (with up to $2.0 million contingent on future revenue), including assets such as trademarks, database content/technology, and customer relationships, with a detailed purchase price allocation. |
Integrated Nonclinical Development Solutions (INDS) | 2022 | Acquired on January 3, 2022 for a total of $8.0 million, INDS brought in the SEND Explorer software and consulting capabilities, with purchase price allocation covering customer relationships, developed technology, non-compete agreements, and goodwill, and was not significant to overall financials. |
Recent press releases and 8-K filings for CERT.
- Certara reported strong financial results for Q2 2025, with 12% year-over-year revenue growth and 13% year-over-year bookings growth.
- Adjusted EBITDA for Q2 2025 increased 21% year-over-year to $31,935 thousand, achieving an Adjusted EBITDA Margin of 31%. Adjusted Diluted EPS was $0.07.
- The company reiterated its full-year 2025 guidance, projecting revenue between $415 million and $425 million, an Adjusted EBITDA Margin of 30-32%, and Adjusted Diluted EPS of $0.42-$0.46.
- Key business updates include the planned launch of the CertaralQ QSP Software Platform in 2H25 and a strategic agreement with Merck.
- Certara's Simcyp® Simulator has been formally qualified by the European Medicines Agency (EMA) for use in regulatory submissions across the EU.
- Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation.
- This qualification enables sponsors to use the Simcyp Simulator in EU regulatory submissions to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility, thereby making the drug submission process easier and faster.
- The qualification covers scenarios where Simcyp simulations can replace clinical DDI studies, significantly reducing the number of clinical studies a sponsor has to conduct.
- Certara, Inc. has appointed Christopher Bouton, Ph.D., as Chief Technology Officer (CTO) to lead the development of its next-generation integrated drug development platform, which combines generative AI with advanced biosimulation technology.
- Bouton's appointment aims to accelerate drug discovery and development by streamlining preclinical research, optimizing clinical trial design, and expediting regulatory submissions, thereby reducing costs and timelines.
- For 2025, Certara reported revenue of $394.5 million, an 8.4% year-over-year increase, with strong gross margins of 60.26% but modest profitability metrics, including a negative EPS of -$0.02 and a net margin of -0.67%.
- Certara highlighted its leadership in biosimulation and the integration of AI to streamline drug development, noting that nearly 90% of FDA-approved drugs have utilized its technology.
- The company emphasized strategic acquisitions—including Pinnacle 21, ChemAxon, and Viasa—as key to expanding its software suite, with targeted investments aimed at shifting its revenue mix more towards software.
- Certara outlined long-term growth prospects based on enhanced R&D spending and improving its technology platform, addressing a market opportunity estimated at approximately $4B.
- Certara Inc discussed its focus on biosimulation and model-informed drug development, noting a balanced revenue mix with approximately 45% software complemented by services.
- The company sees strong near- and long-term revenue opportunities following the FDA directive to reduce animal testing and highlighted its new non-animal Navigator product, supported by high customer engagement.
- Integration of the recent Chemaxon acquisition was emphasized, expanding Certara’s footprint from clinical to preclinical drug discovery.
- Certara also announced execution of a share repurchase authorization and continued pursuit of M&A opportunities to bolster its software revenue mix.
- Revenue reached $106.0 million in Q1 2025, marking a 10% year-over-year growth.
- Net income turned positive at $4.7 million, compared to a loss in Q1 2024.
- Segment performance showed software revenue of $46.4 million (18% growth) and services revenue of $59.6 million (4% growth).
- The company reiterated its full-year guidance of $415–425 million in revenue.
- Preliminary Q1 2025 results showed revenue of $106.0 million (up 10% compared to Q1 2024) with notable software and services revenue growth, and bookings reached $118.0 million (up 12%).
- The company also announced a $100 million share repurchase authorization, reiterated full-year 2025 guidance, and confirmed a one-year lock-up agreement with Arsenal Capital Partners until April 2026.
- Strong Q4 bookings driven by acquisitions, including the integration of Chemaxon and other deals, supported robust organic performance.
- Delivered 2025 revenue guidance of $415–425 million with overall growth of 8–10% and an organic software growth target of 6–8% fueled by organic sales and acquisitions.
- Emphasized AI integration via CoAuthor and advanced regulatory writing tools, with continued R&D investments to enhance core platforms (Simcyp, Phoenix, Pinnacle) and unify cloud architecture.
- Recorded an adjusted EBITDA margin of 32% in Q4, demonstrating effective cost and capacity management.
- Initiated a strategic review of its regulatory business and refined customer segmentation, noting a turnaround in Q4 bookings for Tier 1 despite mixed Tier 2 and 3 performance.
- Maintained an active M&A strategy to support ongoing growth with further opportunistic software deals.
- Certara, Inc. filed an 8-K report on March 5, 2025 detailing recent corporate events.
- Dr. Patrick F. Smith stepped down as President of Certara Drug Development Solutions effective March 3, 2025, while remaining with the company in a senior advisory and scientific role.
- Delivered $100.4M in Q4 2024 revenue, reversing a $12.5M loss to net income of $6.6M with $33.5M in adjusted EBITDA .
- Achieved 14% YoY Q4 revenue growth and posted full-year revenue of $385.1M (9% growth) driven by strong software and services .
- Delivered robust Q4 bookings of $144.5M (up 22% YoY) with significant contributions from Chemaxon .
- Boosted operational performance via its biosimulation business and Chemaxon support, with Chemaxon expected to contribute $23–$25M .
- Provided FY2025 guidance of $415–$425M in revenue and an adjusted EBITDA margin of 30–32%; adjusted diluted EPS is forecast at $0.42–$0.46 .
- Outlook further includes projected organic growth in the range of 4–6% .