What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-03-01 compared with 2022-03-01 · 92 added, 93 removed, 293 unchanged (39% of the section changed)

5 unchanged sentences

Food and Drug Administration (“FDA”).

Moreover, 17 global regulatory authorities license our biosimulation software to independently analyze, verify, and review regulatory submissions, including the FDA, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”), and China’s National Medical Products Administration (“NMPA”).

Moreover, 20 global regulatory authorities license our biosimulation software to independently analyze, verify, and review regulatory submissions, including the FDA, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”), and the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”).

Demand for our offerings continues to expand rapidly.

While traditional drug development has led to meaningful therapies, such as vaccines and chemotherapy, many patients still wait for life-saving medicines, which can take more than 10 years and $2 billion to bring to market.

Change is necessary to continue delivering remarkable gains in human health at an accelerated pace.

We believe that biosimulation enables this change.

While traditional drug development has led to important therapies, such as vaccines and chemotherapy, many patients still wait for life-saving medicines, which can take more than 10 years and $2 billion to bring to market.

Change is necessary to continue delivering meaningful gains in human health at an accelerated pace.

We believe that biosimulation helps enable this change.

We build our biosimulation technology on first principles of biology, chemistry, and pharmacology with proprietary mathematical algorithms that model how medicines and diseases behave in the body.

7 unchanged sentences

One of our customers, a top ten global biopharmaceutical company by R&D spend, estimated that they saved more than half a billion dollars over three years using biosimulation to inform key decisions.

Biosimulation can reduce the size of and cost of human trials, the most expensive and time-consuming part of drug development, and in some cases, eliminate certain human trials completely.

Biosimulation can reduce the size of and cost of human trials, the most expensive and time-consuming part of drug development, and in some cases, eliminate certain human trials completely, thereby accelerating time to market.

An analysis published on Applied Clinical Trials Online, to which we contributed, estimated that $1 billion was saved in clinical trial costs using biosimulation for a cancer drug due to consistently shorter completion times in the later phase clinical trials.

2 unchanged sentences

We have collaborated on more than 7,000 customer projects in the past decade in therapeutic areas ranging from cancer and hematology to diabetes and hundreds of rare diseases.

Over the past 2 years, we have worked on 35 programs on vaccines and therapeutics to combat COVID-19.

Biosimulation results need to be incorporated into regulatory documents for compelling submissions.

Accordingly, we provide regulatory science solutions and integrate them with biosimulation, so that our customers can navigate the complex and evolving regulatory landscape and maximize their chances of approval.

Our differentiated regulatory services are powered by submissions management software and natural language processing for scalability and speed, allowing us to deliver more than 250 regulatory submissions over the past four years.

Our differentiated regulatory services are powered by submissions management software and natural language processing for scalability and speed, allowing us to deliver more than 300 regulatory submissions over the past five years.

Our team of regulatory professionals has extensive experience applying industry guidelines and global regulatory requirements.

2 unchanged sentences

Pinnacle’s products are used by the FDA and Japan’s PMDA to review the quality of submissions.

The final hurdle to delivering medicines to patients is market access, defined as strategies, processes, and activities to ensure that therapies are available to patients at the right price.

A final hurdle to delivering medicines to patients is market access, defined as strategies, processes, and activities to ensure that therapies are available to patients at the right price.

We believe that biosimulation and market access will continue to be increasingly intertwined as healthcare systems and countries move toward outcomes-based pricing.

We provide technology-driven market access solutions, which help our customers understand the real-world impact of therapies and dosing regimens earlier in the process and effectively communicate this to payors and health authorities.

Our solutions are underpinned by software as a service (“SaaS”)-based value communication.

Our solutions are underpinned by software as a service (“SaaS”) based offerings.

We have a proven track record of steady growth, driven by higher adoption of biosimulation, expansion of our technology portfolio, strategic acquisitions, and cross-selling of biosimulation, regulatory science, and market access solutions across our end-to-end platform:

● From 2020 to 202 1, ou r revenue increased by 17% from $243.5 million to $286.1 million.

● From 2021 to 2022 , ou r revenue increa sed by 17% from $286.1 million to $335.6 million.

● The number of customers with Annual Customer Value (“ACV”) of $100,000 or more in revenue increased from 299 in 2021 to 370 in 2022.

5 unchanged sentences

We further reduce the cost and time of human trials to materially accelerate the speed of development and availability of therapies to patients worldwide.

As exciting, new research areas arise, we attract and hire specialized talent and acquire businesses to expand our offerings to address these market opportunities.

As exciting new research areas arise, we attract and hire specialized talent and acquire complementary businesses to expand our offerings to address these market opportunities.

With continued innovation in and adoption of our biosimulation software, technology and services, we believe more biopharmaceutical companies worldwide will leverage more of our end-to-end platform to reduce cost, accelerate speed to market, and ensure safety and efficacy of medicines for all patients.

We believe our addressable market within the biopharmaceutical industry is large and rapidly expanding.

The current total addressable market (“TAM”) for our solutions represents an estimated $13 billion today and is expected to grow at a compound annual growth rate (“CAGR”) of approximately 12% to 16% annually over the next five years.

The current total addressable market (“TAM”) for our solutions represents an estimated $12 billion today and is expected to grow at a compound annual growth rate (“CAGR”) of approximately 9% to 17% annually over the next four years.

Our TAM estimate includes the biosimulation market estimated at $2.8 billion, which is estimated to grow at 17% CAGR over such period according to Grand View Research;

1 unchanged sentence

and the market access market estimated at $1.8 billion, which is estimated to grow at 12% CAGR over such period according to SpendEdge.

With increasing adoption of technology across all stages of drug discovery and development, we believe our end-to-end platform and growth strategies position us to further penetrate the rapidly growing technology-driven biopharmaceutical R&D market of the future.

Traditional drug discovery and development is costly and prone to failure.

The biopharmaceutical industry was estimated to have spent a total of approximately $238 billion in 2022 on R&D.

The probability of success of compounds entering Phase I trials is only 7%.

With only 53% of Phase III drugs reaching the market, late-stage failures are common and especially painful as sponsors have already incurred significant cost and time.

The probability of success of compounds entering Phase I trials continues under 10%.

With less than 50% of Phase III drugs reaching the market, late-stage failures are common and especially disappointing as sponsors have already incurred significant cost and time.

At the same time, scientific advances are driving increased complexity as the R&D pipeline shifts from small molecules to biologics and cell and gene therapies.

16 unchanged sentences

● Optimizing dosing for different populations for enhanced safety and efficacy;

● Increasing probability of success and return on R&D, amongst others.

● Increasing probability of success and return on R&D, among others.

● Regulatory Science :

5 unchanged sentences

● Generating clear, accurate applications and submissions;

● Developing comprehensive global regulatory strategies, amongst others.

● Developing comprehensive global regulatory strategies, among others.

● Market Access :

3 unchanged sentences

● Analyzing payor needs and using economic models to develop contracting strategies that optimize value;

● Collecting and analyzing real-world data for use in market and payor communications, amongst others.

● Collecting and analyzing real-world data for use in market and payor communications, among others.

We believe that our end-to-end platform is well-positioned to continue benefiting from market trends.

12 unchanged sentences

Our integrated set of solutions uniquely positions us to be their first-choice partner.

More than ninety percent of our top 50 customers by revenue use both our biosimulation solutions and regulatory and market access offerings.

Nearly ninety percent of our top 300 customers by revenue use two or more of our biosimulation solutions, regulatory and market access offerings, and other major solutions.

Our Innovation Framework

2 unchanged sentences

● Customer-Centricity :

Through our consortium model and approximately 1,200 biosimulation projects and workshops annually, we derive significant insights that inform the development of our biosimulation software.

Through our consortium model and over 2,000 biosimulation projects and workshops in 2022, we derive significant insights that inform the development of our biosimulation software.

These insights help us to anticipate and align our technology roadmap with our customers’ needs and priorities.

2 unchanged sentences

● Scalable Data Collection and Curation :

Using artificial intelligence and our scientific team, we have curated data from more than 10,000 clinical studies and 18,000 peer-reviewed manuscripts.

Using artificial intelligence and our scientific team, we have curated data from more than 10,000 clinical studies and nearly 15,000 peer-reviewed manuscripts.

We have created 29 different virtual patient populations, approximately 115 compound drug files, 56 clinical outcomes databases, and advanced mathematical models for ten organs.

13 unchanged sentences

● Long-Standing Regulatory Partnerships :

Seventeen regulatory agencies license our biosimulation software.

Twenty regulatory agencies license our biosimulation software.

In addition, our scientists are regularly invited by U.S, European, and Japanese regulatory agencies to teach and participate in their workshops.

6 unchanged sentences

We recognize that education in the theory and practice of biosimulation is pivotal to adoption and achieving the benefits of biosimulation.

Certara University provided in-person and online training on biosimulation and the use of our biosimulation software to more than 3,000 scientists in 2021.

Certara University provided in-person and online training on biosimulation and the use of our biosimulation software t o more than 4,500 scientists in 2022.

The Deep Expertise of Our People and Our Culture of Innovation

2 unchanged sentences

highly value.

As of December 31, 2021, 352 of our employees held PhD, PharmD, or MD degrees.

As of December 31, 2022, 380 of our employees held PhD degrees.

Our team of software engineers and technologists excels at applying computer science, engineering, and scientific and mathematical principles in designing and developing complex software with consistent execution.

6 unchanged sentences

We remain focused on reducing the cost, time, and probability of failure of clinical trials for our customers, so that they can materially accelerate the availability of future therapies that are needed by patients worldwide.

As exciting, new research areas arise, such as cell and gene therapy, we attract and hire specialized talent and acquire businesses to expand our offerings accordingly.

As exciting, new research areas arise, such as cell and gene therapy, we attract and hire specialized talent and acquire complementary businesses to expand our offerings accordingly.

Advance Our Technology

The science, technology, and data behind biosimulation continue to advance rapidly, and our top investment priority is to develop additional functionality and uses for biosimulation to improve patient outcomes.

We release new software, additional features, and upgrades on a frequent and regular basis.

In 2021, we introduced 10 new software applications and upgrades, including Secondary Intelligence, D360 Scientific Informatics, Simcyp Immuno-oncology Quantitative Systems Pharmacology (“QSP”) and Pinnacle 21 Enterprise.

We are investing in three major areas to elevate our technology:

In 2022, we introduced 20 new software applications and upgrades, including Simcyp Discovery Simulator and Pinnacle 21 Enterprise Tier 2, a new advanced tier of modules for Data Exchange and Specification Design.

We are investing in four major areas to elevate our technology:

● Spearheading the Frontier of QSP and Toxicology , an emerging approach with enormous potential for industry-wide transformation to optimize decisions in both drug discovery and development.

In addition to QSP for immunogenicity, immuno-oncology, and COVID-19, we are ramping up our QSP consortia for neurodegenerative diseases, such as Alzheimer’s and Parkinson’s, and for quantitative systems toxicology and safety (“QSTS”).

In addition to QSP for immunogenicity, immuno-oncology, and COVID-19, we are ramping up our quantitative systems pharmacology (“QSP”) consortia for neurodegenerative diseases, such as Alzheimer’s and Parkinson’s, and for quantitative systems toxicology and safety (“QSTS”).

Neuroscience is expected to have the most growth in QSP modeling over the next several years, followed by oncology and autoimmune disorders.

3 unchanged sentences

● Architecting an Ecosystem of Interconnected Software Applications to facilitate seamless workflows and sharing of data across the drug discovery and development continuum for efficiency and speed.

● Applying and embedding Artificial Intelligence across our technologies and databases to drive further insights and analysis.

Grow Within Our Existing Customer Base

1 unchanged sentence

Our scientists and regulatory and market access experts, business developers, marketing professionals, and business leaders work together to ensure a high-quality customer experience and nurture long-term partnerships.

As a result, our customer relationships grow steadily over time, driven by higher adoption of biosimulation with additional user licenses and more modules.

result, our customer relationships grow steadily over time, driven by higher adoption of biosimulation with additional user licenses and more modules.

We also cross-sell our software and technology-driven services throughout our end-to-end platform.

Many of our customers who use biosimulation also rely on us for regulatory strategy, writing, and submissions support, including the

majority of our top 50 customers.

Many of our customers who use biosimulation also rely on us for regulatory strategy, writing, and submissions support, including the majority of our top 50 customers.

The number of customers with annual customer value of $100,000 or more in revenue increased from 299 in 2021 to 370 in 2022, a 24% increase.

The success of our land and expand approach is further demonstrated by our high re-occurring revenue streams with an aggregate renewal rate of 92% for our software customers from 2020 to 2021 and net revenue repeat rate (defined as the level of technology-driven services revenue generated from our existing customers from period to period, accounting for expansion and churn) of 108% for our technology-driven

The success of our land and expand approach is further demonstrated by our high re-occurring revenue streams with an aggregate renewal rate of 91% for our software customers from 2021 to 2022 and net revenue repeat rate (defined as the level of technology-driven services revenue generated from our existing services customers from period to period, accounting for expansion and churn) of 101% for our technology-driven services customers from 2021 to 2022.

Expand Our Customer Base Globally

We are growing our footprint globally to match that of the biopharmaceutical industry.

There are nearly 5,100 biopharmaceutical companies worldwide with active R&D pipelines, up from nearly 2,400 in 2011, according to Informa’s Pharma R&D Annual Review 2021.

There are more than 5,400 biopharmaceutical companies worldwide with active R&D pipelines in 2022, up from nearly 2,400 in 2011, according to Informa’s Pharma R&D Annual Review 2022.

Informa also estimates that the R&D pipeline encompassed more than 20,000 drug programs in 2022.

As drug discovery and development in Asia Pacific grows, we are investing heavily to expand our presence in the region to work with these customers where they are, just as we already have in North America, Europe and Japan.

We continue to build our sales and marketing capabilities and capacity to expand our global reach.

2 unchanged sentences

We have a proven record of successfully acquiring and integrating software and services companies.

To date, we have acquired 15 companies of which 10 included software or technology such as Simcyp, the core of our mechanistic biosimulation platform, Xenologiq, which jumpstarted our biosimulation initiative using QSP, and Pinnacle 21, which enhances our software offerings in data management and the regulatory drug approval process.

From 2012, we have acquired 17 companies of which 12 included software or technology such as Simcyp, the core of our mechanistic biosimulation platform, Xenologiq, which jumpstarted our biosimulation initiative using QSP, Pinnacle 21, which enhances our software offerings in data management and the regulatory drug approval process, and Vyasa, which brings state-of-the-art artificial intelligence (AI) capabilities to our end-to-end platform.

As we build out the depth and breadth of our biosimulation platform, we continually seek and assess a range of highly focused opportunities in our immediately addressable market and in related adjacent markets, whether through acquisitions, licenses, or partnerships.

8 unchanged sentences

Our software is primarily subscription-based with licenses ranging from one to three years.

Certara End-to-end Platform

Our software, utilized by more than 20,000 licensed users in biosimulation and 40,000 more in regulatory, compliance and market access, addresses seven main applications:

2 unchanged sentences

3) data standardization and compliance software;

4) scientific informatics 5) clinical outcomes databases for biosimulation;

4) scientific informatics;

outcomes databases for biosimulation;

6) authoring and management of regulatory submissions;

2 unchanged sentences

● Mechanistic Biosimulation Platform (Simcyp) :

Mechanistic biosimulation predicts both how a drug is handled within the body (known as “pharmacokinetics” or “PK”) and drug effect (known as “pharmacodynamics” or

“PD”), without the need for actual in vivo human or animal studies.

Eighteen of the top 20 biopharmaceutical companies by R&D spend in 2020 used the Simcyp Platform in 2021.

Mechanistic biosimulation predicts both how a drug is handled within the body (known as “pharmacokinetics” or “PK”) and drug effect (known as “pharmacodynamics” or “PD”), without the need for actual in vivo human or animal studies.

Seventeen of the top 20 biopharmaceutical companies by R&D spend in 2021 used the Simcyp Platform in 2022.

Simcyp includes three main modules:

11 unchanged sentences

Our Simcyp Platform has generated results that inform more than 300 label claims for nearly 90 drugs.

Had customers attempted to acquire the same information through conventional human trials, we believe they would have faced millions of dollars in additional costs and significant launch delays, given that clinical trials are estimated to take 1 to 2.5 years on average and cost many millions of dollars, according to Nature Reviews Drug Discovery.

Had customers attempted to acquire the same information through conventional human trials, we believe they would have faced in aggregate tens of millions of dollars in additional costs and significant launch delays, given that clinical trials are estimated to take 1 to 2.5 years on average and cost many millions of dollars, according to Nature Reviews Drug Discovery.

● Empirical PK/PD Biosimulation Platform (Phoenix) :

11 unchanged sentences

The platform includes chemical structure search capabilities for structure-activity relationship analysis, molecular design tools and visualization solutions.

The product connects seamlessly with biology and chemistry data systems from third-party companies, without extensive IT setup and maintenance.

product connects seamlessly with biology and chemistry data systems from third-party companies, without extensive IT setup and maintenance.

● Clinical Outcomes Databases for Biosimulation (CODEx) :

2 unchanged sentences

● Authoring and Management of Regulatory Submissions Platform (GlobalSubmit) :

Our customers license our advanced, cloud-based electronic common technical document (“eCTD”) software for publishing, review, validation, and electronic filing of regulatory submissions.

Our customers license our advanced, cloud-based electronic common technical document (“eCTD”) software for publishing, reviewing, validating and electronic filing of regulatory submissions.

● Market Access Communication Platform (BaseCase) :

2 unchanged sentences

Technology-Driven Services

Our technology-driven, biosimulation services help customers who do not have staff capability or availability to gain the benefits of biosimulation.

Our technology-driven, biosimulation services help our customers who do not have staff capability or availability to gain the benefits of biosimulation.

We also provide related, technology-driven services to guide our customers’ new drugs through the regulatory submission process and into the market.

15 unchanged sentences

We support submissions from early-stage investigational new drugs to late-stage new drug applications, biologics license applications, and market authorization applications, by writing regulatory documents such as clinical study protocols/reports, safety submissions, and other summary documents for submission to the FDA and global regulatory authorities.

We manage technical editing including transparency and disclosure services to ensure that our customers’ regulatory documents are “filing-ready.” Our team also offers advanced publication planning and writing support for scientific and medical publications.

We manage technical editing including transparency and disclosure services to ensure that our customers’ regulatory documents are

“filing-ready.” Our team also offers advanced publication planning and writing support for scientific and medical publications.

We deploy natural language processing software and other technology to enable efficient and scalable document creation.

2 unchanged sentences

Our submission management services include submission leadership, program management and planning, due diligence and readiness preparation, submission compilation, and eCTD publishing.

We support applications to

all major health agencies, including the FDA, Europe’s EMA, Health Canada, Japan’s PMDA, and China’s NMPA.

We support applications to all major health agencies, including the FDA, Europe’s European Medicines Agency ("EMA"), Health Canada, Japan’s PMDA, and China’s NMPA.

● Market Access:

7 unchanged sentences

The market for our biosimulation products and related services for the biopharmaceutical industry is competitive and highly fragmented.

In biosimulation software market, we primarily compete with companies smaller than ourselves, such as Simulations Plus and NONMEM, a division of ICON.

In the biosimulation software market, we primarily compete with companies smaller than ourselves, such as Simulations Plus and NONMEM, a division of ICON.

Other competitors include Schrodinger, open-sourced solutions such as R and PK-Sim, and internally-developed software in biopharmaceutical companies.

We generally compete in the biosimulation software market on the basis of the quality and capabilities of our products, our scientific and technical expertise, our ability to innovate and develop solutions attractive to customers, our customer and regulatory agency partnerships, and price, amongst other factors.

Our technology-driven services generally compete with companies significantly smaller than ourselves, such as Metrum Research Group and Simulations Plus.

1 unchanged sentence

In some standard biosimulation services and in regulatory science and market access, we compete with contract research organizations.

We generally compete in the technology-driven services markets on the basis of our reputation and experience, our expertise and the qualifications of our team, our ability to offer services attractive to customers, and price, amongst other factors.

We generally compete in the technology-driven services markets on the basis of our reputation and experience, our expertise and the qualifications of our team, our ability to offer services that are attractive to customers, and price, among other factors.

We believe that our competitive position is strong, and that we are able to effectively win new projects with our integrated, end-to-end platform.

Intellectual Property

We safeguard and enhance our innovative technology platforms, systems, processes, and databases with a full array of intellectual property rights, including copyrights, trade secrets and know-how, patents, and tradenames/trademarks.

All of our proprietary software products are copyright protected, and further reinforced by contractual provisions in our software license agreements prohibiting our users from reverse engineering, deriving, or otherwise using the source code and underlying algorithms for anything other than the permitted and intended use.

Embedded within some of our biosimulation tools, including the Simcyp Simulator, are several decades’ worth of proprietary data that have been compiled and collated from both public and private sources.

Embedded within some of our biosimulation tools, including the Simcyp Simulator, are several decades’ worth of proprietary data that have been

compiled and collated from both public and private sources.

These data, in tandem with our proprietary source code and algorithms, create powerful modeling tools that cannot be readily duplicated.

Continual ongoing development of source code and algorithms as well as new version release of modelling tools also ensures that our proprietary software products are difficult to copy.

Continual ongoing development of source code and algorithms as well as new version release of modeling tools also ensures that our proprietary software products are difficult to copy.

Our processes and systems are further protected by trade secrets and know-how, which we secure by requiring and strictly enforcing confidentiality obligations with our employees, contractors, customers, and other third parties, and invention assignment agreements with our employees, as well as through administrative and technical safeguards.

However, trade secrets and confidential know-how are difficult to protect.

Agreements may not always provide

meaningful protection.

Agreements may not always provide meaningful protection.

These agreements may also be breached, and we may not have an adequate remedy for any such breach.

10 unchanged sentences

We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors.

We also have applied for and/or obtained and maintain registration in the United States and other countries for numerous trademarks, including Certara, Simcyp, Phoenix, Pinnacle 21, Virtual Twin, WinNonlin, and BaseCase.

We pursue trademark registrations to the extent we believe doing so would be beneficial to our competitive position.

2 unchanged sentences

We are led by a diverse, global, and talented team of scientists, software developers, and subject matter experts who seek to understand our customers’ challenges and are dedicated to tackling these challenges.

As of December 31, 2021, we employed a total of 1,114 individuals, including 1,054 full-time employees and 60 part-time employees, of which 352 held Ph.Ds.

As of December 31, 2022, we employed a total of 1,204 individuals, including 1,150 full-time employees and 54 part-time employees, of which 380 held PhDs.

in their respective disciplines, including clinical pharmacology and pharmacometrics.

1 unchanged sentence

Most of the senior management team and the members of our board of directors hold either PhDs and/or other advanced degrees.

We are very proud to say that some of the world-leading experts in biosimulation, drug discovery and development, software development, regulatory science, and market access work and thrive at Certara.

We offer employees a myriad of professional development opportunities and encourage a performance-driven environment.

In 2021, we focused on creating a robust culture in a remote work environment to encourage retention and engagement, and instituted a number of health and wellness initiatives, such as a global fitness challenge.

We also enhanced our diversity and inclusion programs, including instituting company-wide unconscious bias training and expanding our recruiting efforts to reach a more diverse talent pool, in keeping with our CEO’s pledge to act on supporting a more inclusive workplace.

We offer our employees a myriad of professional development opportunities and support a performance-driven environment.

In 2022, we focused on continuing to build a robust culture in a remote work environment by encouraging engagement and retention through Employee Spotlight programs and CEO Chats, and instituting a number of health and wellness initiatives, such as a global fitness challenge, yoga and meditation programs.

We also enhanced our diversity and inclusion programs, including continuing company-wide unconscious bias training and expanding our recruiting efforts to reach a more diverse talent pool, in keeping with our CEO’s pledge to act on supporting a more inclusive workplace.

None of our employees are represented by a labor union, and we have never experienced a work stoppage.

We believe that our relations with our employees are positive.

In alignment with our purpose to accelerate medicine to patients, we strive to reinforce a positive and rewarding work environment for our employees.

Government Regulation

Regulation of Biopharmaceutical Products

The development, testing, manufacturing, labeling, approval, promotion, distribution and post-approval monitoring and reporting of biopharmaceutical products are subject to regulation by numerous governmental authorities at both the national and local levels, including the FDA in the United States, as well as those of other countries, such as the EMA in the European Union and the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

Although our biosimulation software products and platforms are not approved by the FDA or other government agencies, our customers’ products are subject to these regulations, which may be applicable to us to the extent that the services and deliverables we provide to our customers are used in their marketing applications.

4 unchanged sentences

To help ensure compliance with GLP and GCP, we have established a robust quality management system that includes standard operating procedures, working practice documents and processes, and quality assurance personnel to audit deliverables intended to be used in our customers’ drug and biologic approval applications.

Privacy and Security Laws

The collection, processing, use, disclosure, disposal and protection of information about individuals, in particular healthcare data, is highly regulated both in the United States and other jurisdictions, including but not limited to, under Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”);

state privacy, security and breach notification and healthcare information laws;

the European Union’s General Data Protection Directive (“GDPR”;

and other European privacy laws as well as privacy laws being adopted in other regions around the world.

Although most of the clinical data we receive from our customers is de-identified, in certain parts of our business, such as our real-world data and analytics program, we hold confidential personal health and other information relating to persons who have been, are and may in the future be involved in clinical trials.

The possession, retention, use and disclosure of such information is highly regulated, including under the laws and regulations described above.

These data privacy and security regulations govern the use, handling and disclosure of information about individuals and, in the case of HIPAA, require the use of standard contracts, privacy and security standards and other administrative simplification provisions.

Privacy and Cybersecurity Laws

The collection, use, disclosure, disposal, protection other processing of information about individuals, in particular healthcare data, is highly regulated both in the United States, EU and other jurisdictions, including but not limited to, under the U.S.

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and other U.S.

privacy, security and breach notification and healthcare information laws;

the European Union’s General Data Protection Directive (“GDPR” and its national implementing laws) and other European privacy laws as well as privacy laws in other jurisdictions around the world.

Although most of the clinical data we receive from our customers is de-identified within the meaning of HIPAA, in certain parts of our business, such as our real-world data and analytics program, we hold personal health and other information relating to persons who have been, are and may in the future be involved in clinical trials.

The collection, retention, use, disclosure and other processing of such information is highly regulated, including under the laws described above.

These data privacy and cybersecurity laws govern the use, handling and disclosure of information about individuals.

In relation to HIPAA, we do not consider our service offerings to generally cause us to be subject as a covered entity;

however, in certain circumstances we are subject to HIPAA as a business associate and may enter into business associate agreements with our customers who are covered entities under HIPAA.

These business associate agreements define our obligations to safeguard the personal health information of patients provided by our customers.

We have adopted identity protection practices and have implemented procedures to satisfy data protection requirements and safeguards regarding the creation, receipt, maintenance and transmission of protected health information.

In addition, the Federal Trade Commission (the “FTC”) and many state attorneys general are interpreting existing federal and state consumer protection laws to impose evolving standards for the online collection, use, dissemination and security of information about individuals, including health-related information.

however, in certain circumstances we are subject to HIPAA as a business associate.

HIPAA requires the use of standard contracts (business associate agreements), notice and consent procedures and other privacy and cybersecurity standards.

Accordingly, we may enter into business associate agreements with our customers who are covered entities under HIPAA.

These business associate agreements define our obligations to safeguard the protected health information of patients provided by our covered-entity customers.

We have adopted practices and have implemented procedures to satisfy the privacy and security rules and other to safeguard the receipt, maintenance and transmission of protected health information.

In addition, the Federal Trade Commission (the “FTC”) and many state attorneys general interpret federal, state and local consumer protection laws to impose evolving standards for the handling and security of personal information, including health-related information.

Courts may also adopt the standards for fair information practices promulgated by the FTC, which concern consumer notice, choice, security and access.

Consumer protection laws require us to publish statements that describe how we handle information about individuals and choices individuals may have about the way we handle their information.

Certain states have also adopted robust data privacy and security laws and regulations.

For example, the California Consumer Privacy Act (“CCPA”), which took effect in 2020, imposes obligations and restrictions on businesses regarding their collection, use, and sharing of personal information and provides new and enhanced data privacy rights to California residents, such as affording them the right to access and delete their personal information and to opt out of certain sharing of personal information.

Protected health information that is

subject to HIPAA is excluded from the CCPA, however, information we hold about individuals which is not subject to HIPAA would be subject to the CCPA It is unclear how HIPAA and the other exceptions may be applied under the CCPA.

The collection, use, storage, disclosure, transfer, or other processing of any personal data regarding individuals in the European Union, including personal health data, is subject to the GDPR, which became effective on May 25, 2018.

The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.

The GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater.

The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

Recent legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the European Economic Area (“EEA”) to the United States, e.g.

on July 16, 2020, the Court of Justice of the European Union (the “CJEU”) invalidated the Privacy Shield under which personal data could be transferred from the EEA to U.S.

entities who had self-certified under the Privacy Shield scheme.

While the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances;

Certain states have also adopted robust data privacy laws.

For example, the California Consumer Privacy Act (“CCPA”), which became effective on January 1, 2020, as amended by the California Privacy Rights Act , which became effective

on January 1, 2023, imposes obligations and restrictions on businesses regarding their collection, use, and sharing of personal information and provides new and enhanced data privacy rights to California residents, such as affording them the right to access and delete their personal information and to opt out of certain sharing of personal information.

Additional privacy laws in Virginia, Connecticut, Colorado and Utah which also take effect during 2023 have similar requirements but more limited application (i.e., only consumers and not employees or B2B data).

The interpretation and application of the new state laws and their pending regulations are uncertain.

The processing of any personal data regarding individuals in the European Economic Area (“EEA”) , including personal health data, is subject to the GDPR as of May 25, 2018.

The GDPR and the UK’s post-Brexit equivalent of the GDPR (“UK GDPR”) is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive personal data, cross-border transfers, notice and consent and contractual obligations with vendors and service providers.

The GDPR permits data protection authorities to impose large administrative penalties for violations of the GDPR or UK GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater, for each law.

Legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States, including the Court of Justice of the European Union (the “CJEU”) decision to invalidate the EEA to U.S.

personal data transfer framework as well as decisions from regulators in Austria, Denmark, France and Italy about transfers made by Google.

We also currently rely on the standard contractual clauses to transfer personal data outside the EEA, including to the United States, among other data transfer mechanisms pursuant to the GDPR.

While the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism,), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances;

this has created uncertainty.

We have previously relied on our own Privacy Shield certification and our relevant customers’/ clients’/ partners’/ providers’/ third parties’ Privacy Shield certification(s) for the purposes of transferring personal data from the EEA to the United States in compliance with the GDPR’s data export conditions.

We also currently rely on the standard contractual clauses to transfer personal data outside the EEA, including to the United States, among other data transfer mechanisms pursuant to the GDPR, but excluding Privacy Shield.

In response to the data privacy laws and regulations discussed above and those in other countries in which we do business, we have implemented several technological safeguards, processes, contractual third-parties provisions, and employee trainings to help ensure that we handle information about our employees, customers, and in a compliant manner.

We maintain a global privacy policy and related procedures, and train our workforce to understand and comply with applicable privacy laws.

In response to the data privacy laws discussed above and those in other countries in which we do business, we have implemented a multi-disciplinary privacy management program that includes technological safeguards, processes, contractual third-parties provisions, and employee trainings to help ensure that we handle information about our employees and customers in a compliant manner.

Concurrently, we observe a trend toward expanding privacy data protection law both in number and scope that will expand our obligations.

We may need to modify our practices and incur expenses to accommodate this evolving privacy compliance landscape.

Bribery, Anti-Corruption and Other Laws

13 unchanged sentences

We have used, and intend to continue to use, our Investor Relations website and our corporate website located at www.certara.com as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

The following filings are available through our Investor Relations website as soon as reasonably practicable after we file them with, or furnish them to, the SEC:

The following filings are available

through our Investor Relations website as soon as reasonably practicable after we file them with, or furnish them to, the SEC:

Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and our Proxy Statement for our annual meeting of stockholders, as applicable (as well as any amendments to those reports).

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business