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Item 1. Business

2022-03-01 compared with 2021-03-15 · 85 added, 80 removed, 301 unchanged (35% of the section changed)

We accelerate medicines to patients using biosimulation software and technology to transform traditional drug discovery and development.

We accelerate medicines to patients using biosimulation software, technology, and services to transform traditional drug discovery and development.

Biosimulation is a powerful technology used to conduct virtual trials using virtual patients to better understand how drugs behave in different individuals.

Biopharmaceutical companies use our proprietary biosimulation software throughout drug discovery and development to inform critical decisions that not only save significant time and money but also advance drug safety and efficacy, improving millions of lives each year.

As a global leader in biosimulation based on 2020 revenue, we provide an integrated, end-to-end platform used by more than 1,650 biopharmaceutical companies and academic institutions across 61 countries, including all of the top 35 biopharmaceutical companies by R&D spend in 2019.

Since 2014, customers who use our biosimulation software and technology-enabled services have received over 90% of all new drug approvals by the U.S.

As a global leader in biosimulation based on 2021 revenue, we provide an integrated, end-to-end platform used by more than 2,000 biopharmaceutical companies and academic institutions across 62 countries, including 38 of the top 40 biopharmaceutical companies by R&D spend in 2020.

Since 2014, customers who use our biosimulation software and technology-driven services have received 90% of all new drug approvals by the U.S.

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, Europe’s European Medicines Agency (“EMA”), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”), and China’s National Medical Products Administration (“NMPA”).

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”).

Demand for our offerings continues to expand rapidly.

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

We, and many others in the biopharmaceutical industry, believe that biosimulation enables this change.

We believe that biosimulation enables 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.

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We have collaborated on more than 5,000 customer projects in the past decade in therapeutic areas ranging from cancer and hematology to diabetes and hundreds of rare diseases.

Over the past year, we have worked on more than 30 programs on vaccines and therapeutics to combat COVID-19.

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.

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

In addition, in October 2021, we completed the acquisition of Pinnacle 21, LLC (“Pinnacle”), which develops advanced software for standards-based data management for regulatory submission.

Pinnacle enhances our software offerings in data management and the regulatory drug approval process, accelerating the speed and efficiency of developing and bringing drugs to market.

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.

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

We have recently expanded into technology-enabled 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 technologies such as Bayesian statistical software and software as a service (“SaaS”)-based value communication tools.

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.

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 2019 to 2020, our revenue increased by 17% from $208.5 million to $243.5 million.

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

● The number of customers with Annual Customer Value (“ACV”) of $100,000 or more in revenue increased from 261 in 2020 to 299 in 2021.

● The number of customers with ACV of $1,000,000 or more in revenue increased from 44 in 2019 to 53 in 2020.

We believe that biosimulation is at an inflection point, driven by increasing global regulatory adoption and advancements in technology.

We believe that biosimulation continues to grow in adoption, driven by increasing global regulatory support and advancements in technology.

We believe we are well-positioned to capture the significant market opportunity ahead of us.

Our growth strategy is to build out the depth and breadth of our scalable, end-to-end biopharmaceutical platform to advance all stages of the continuum, from discovery and development to regulatory submission and market access.

We continue to innovate and introduce new functionality and uses of biosimulation and technology-enabled solutions.

We continue to innovate and introduce new functionality and uses of biosimulation and technology-driven solutions.

We increasingly integrate the science and data we obtain across this end-to-end platform to inform critical decisions.

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

With continued innovation in and adoption of our biosimulation software and technology-enabled 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.

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.

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and the market access market estimated at $1.5 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-enabled 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 $212 billion in 2021 on R&D.

It takes more than 10 years to bring a drug to market, and the cost has grown significantly in the past decade from $1.2 billion in 2010 to $2.0 billion in 2019.

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

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Continued development and innovation in software and technology such as biosimulation, virtual trials, and real-world evidence tools are helping biopharmaceutical companies increase efficiency and decrease costs.

This is further supported by regulatory agencies that have increasingly issued guidance on the adoption of many of these innovations.

This is further supported by regulatory agencies that have increasingly issued guidance that supports adoption of many of these innovations.

For example, the FDA recently announced their Project Optimus initiative to reform the dose selection and optimization paradigm in oncology drug development to maximize both efficacy and safety.

Biosimulation's use cases in dose finding and optimization are well-suited to help biopharmaceutical companies navigate this evolving regulatory landscape.

As technology and analytics become increasingly powerful and the application of new solutions is validated, we anticipate this will drive further demand for these innovations.

We believe we are still in the early stages of a long-term trend that will continue to advance traditional drug discovery and development into a technology-enabled era of advanced modeling and analytics.

In addition, as a result of the COVID-19 pandemic, we believe that the demand for innovative technology solutions in drug discovery and development is accelerating.

Disruption of clinical trials during the pandemic has highlighted some of the limitations of human trials and is expected to drive increased utilization of technology during and after the pandemic.

Sponsors, regulators, and their partners have adopted a number of technology-driven solutions and procedures, which we believe they will continue to utilize and benefit from in the post-COVID environment.

Moving forward, we believe there will be an increase in adoption of software and technology-enabled solutions as a means to proactively mitigate the future risks of disruptions to clinical trials.

We believe that these trends will only serve to accelerate our market opportunity.

We believe we are still in the early stages of a long-term trend that will continue to advance traditional drug discovery and development into a technology-driven era of advanced modeling and analytics.

In addition, as a result of the COVID-19 pandemic, we believe that the demand for innovative technology solutions in drug discovery and development will continue to be strong.

Sponsors and regulators have adopted a number of technology-driven solutions and procedures, which we believe they will continue to use and benefit from in the post-COVID environment.

Our core markets today include:

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Our Competitive Strengths

We compete by offering a broad and deep combination of industry-standard biosimulation software and technology-enabled services across all stages of the continuum, from discovery and development to regulatory approval and market access.

We compete by offering a broad and deep combination of industry-standard biosimulation software and technology-driven services across all stages of the continuum, from discovery and development to regulatory approval and market access.

We have cultivated the following competitive strengths for more than two decades:

Our Proprietary, Scalable Biosimulation Software

Our proprietary, scalable biosimulation software, built on first principles and including more than 9.3 million lines of code, integrates biosimulation models, scientific knowledge, and data, which we believe would require years of effort, immense resources, and scarce expertise to duplicate.

Our proprietary, scalable biosimulation software, built on first principles integrates biosimulation models, scientific knowledge, and data, which we believe would require years of effort, immense resources, and scarce expertise to duplicate.

Our versatile biosimulation software is deployed to public and private cloud networks, on-premises, and data centers.

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Our Integrated End-to-End Platform

We have developed a differentiated, integrated end-to-end platform of software and technology-enabled services, powered by proprietary technology and unique talent, spanning discovery through market access.

We have developed a differentiated, integrated end-to-end platform of software and technology-driven services, powered by proprietary technology and unique talent, spanning discovery through market access.

Our customers, facing declining R&D productivity and an increasingly complex regulatory and market access environment, seek trusted partners to accelerate their R&D programs and achieve regulatory and commercial success.

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● Regulatory Alignment :

As we continuously engage with regulators through our customers’ programs, training workshops, and attendance at FDA and other regulator meetings, we develop an in-depth understanding of how to align our biosimulation software and services to meet evolving regulatory expectations and requirements.

As we continuously engage with regulators through our customers’ programs, training workshops, and attendance at FDA and other regulator meetings, we develop an in-depth understanding of how to align our biosimulation software and service s to meet evolving regulatory expectations and requirements.

● 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.

We have created 25 different virtual patient populations, approximately 100 compound drug files, more than 45 clinical outcomes databases, and advanced mathematical models for ten organs.

We have created 25 different virtual patient populations, approximately 100 compound drug files, 55 clinical outcomes databases, and advanced mathematical models for ten organs.

● Scientific Research :

We work with our customers, a scientific advisory board of thought leaders, and more than 120 academic institutions to innovate bottom-up, mechanistic models of drug, disease, and human biology.

We work with our customers, a scientif ic advisory board of thought leaders, and academic institutions to innovate bottom-up, mechanistic models of drug, disease, and human biology.

Each mathematical equation or parameter estimation is based on up-to-date scientific knowledge and data.

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Our Trusted, Long-Term Customer and Regulatory Partnerships

We work continuously and closely with our customers to provide software and technology-enabled services from drug discovery and development to regulatory science and market access, applying biosimulation throughout the continuum to maximize R&D productivity and increase the probability of success.

We work continuously and closely with our customers to provide software and technology-driven services from drug discovery and development to regulatory science and market access, applying biosimulation throughout the continuum to maximize R&D productivity and increase the probability of success.

We have substantial repeat business and long-term partnerships.

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

We have received four grants and a Cooperative Research and Development Agreement from the FDA as well as grants from six European organizations, including the EU Commission, to develop biosimulation models and conduct biosimulation analyses.

We have received six grants and a Cooperative Research and Development Agreement from the FDA as well as grants from seven European organizations, including the EU Commission, to develop biosimulation models and conduct biosimulation analyses.

● Academic Centers of Excellence :

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

Certara University provides in-person and online training on biosimulation and the use of our biosimulation software to more than 4,500 scientists in the past three years.

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.

The Deep Expertise of Our People and Our Culture of Innovation

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highly value.

As of December 31, 2020, approximately 300 of our employees held PhD, PharmD, or MD degrees.

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

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

In the past two years, we have introduced more than 10 new software applications and upgrades, including D360 Biologics Scientific Informatics, Simcyp Immuno-oncology Quantitative Systems Pharmacology (“QSP”), and COVID-19 Quantitative Systems Pharmacology.

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:

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All of our mechanistic simulators communicate seamlessly with each other, which is a major advantage for complex drug discovery and development programs.

● Continuing to Develop Cloud-Based Solutions , such as Certara Integral Data Repository, CODEx Clinical Outcomes Databases, and BaseCase Value Communication Software, which enhance computing scalability, significantly reduce maintenance time and cost, and promote access, collaboration and mobility.

● Continuing to Develop Cloud-Based Solutions , such as Certara Integral Data Repository, CODEx Clinical Outcomes Databases, BaseCase Value Communication Software, and Pinnacle 21 Enterprise, which enhance computing scalability, significantly reduce maintenance time and cost, and promote access, collaboration and mobility.

This also allows us to easily deliver new features and explore new business models.

● 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.

Grow Within Our Existing Customers

Grow Within Our Existing Customer Base

As we continue to expand our portfolio of offerings, we integrate our solutions and sell more across our end-to-end platform.

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As a 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-enabled 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.

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.

The number of customers with annual customer value of $100,000 or more in revenue increased from 261 in 2020 to 299 in 2021, a 15% 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 90% for our software customers from 2019 to 2020 and net revenue repeat rate (defined as the level of technology-enabled services revenue generated from our existing customers from period to period, accounting for expansion and churn) of 116% for our technology-enabled services customers from 2019 to 2020.

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

Expand Our Customer Base Globally

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

There are more than 4,800 biopharmaceutical companies worldwide with active R&D pipelines, up from nearly 2,400 in 2011, according to Informa’s Pharma R&D Annual Review 2020.

Informa also estimates that the R&D pipeline encompasses approximately 18,000 drug programs in 2020.

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.

Informa also estimates that the R&D pipeline encompassed more than 18,000 drug programs in 2021.

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.

In October 2020, we opened an office in Shanghai, China.

Scale Through Acquisitions

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

To date, we have acquired 12 companies of which nine included software or technology such as Simcyp, the core of our mechanistic biosimulation platform, and Xenologiq, which jumpstarted our biosimulation initiative using QSP.

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.

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.

Inspire Our People

Our people, 900 strong, are the key to our success.

Our more than 1,100 employees are the key to our success.

The diversity and depth of expertise, experience, and backgrounds in our vibrant community bring richness of ideas, problem-solving capabilities, and mutual respect.

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The Certara End-to-End Platform

We provide both software and technology-enabled services to enable customers to realize the full benefits of biosimulation in drug discovery, preclinical and clinical research, regulatory submission, and market access.

We provide both software and technology-driven services to enable customers to realize the full benefits of biosimulation in drug discovery, preclinical and clinical research, regulatory submission, and market access.

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 28,000 more in regulatory and market access, addresses six main applications:

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:

1) mechanistic biosimulation;

2) empirical pharmacokinetic and pharmacodynamic biosimulation;

3) scientific informatics;

4) clinical outcomes databases for biosimulation;

3) data standardization and compliance software;

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

6) authoring and management of regulatory submissions;

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● 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 .

Seventeen of the top 20 biopharmaceutical companies by R&D spend in 2019 licensed 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.

Simcyp includes three main modules:

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● Quantitative systems toxicology and safety :

QSTS integrates toxicology with quantitative analysis of large networks of molecular and functional biological changes to identify drug toxicity and adverse drug reactions earlier.

Our Simcyp Platform has generated results that inform approximately 250 label claims for more than 75 drugs.

Had customers attempted to acquire the same information through conventional human trials, we believe they would have faced millions 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.

Secondary Intelligence, our QSTS software, integrates toxicology with quantitative analysis of large networks of molecular and functional biological changes to identify drug toxicity and adverse drug reactions earlier.

Our Simcyp Platform has generated results that inform more than 250 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.

● Empirical PK/PD Biosimulation Platform (Phoenix) :

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Furthermore, customers can be confident they are using the same tools used by regulators to evaluate their products.

● Data Standardization and Compliance Software ( Pinnacle 21 Enterprise ) :

Pinnacle 21 Enterprise helps to ensure that submission data is compliant with regulatory standards, which helps to enable a more efficient review process.

Data standards are complex and increasingly challenging to adhere to as the volume of data in clinical trials continues to grow.

Pinnacle 21 Enterprise creates consistent, compliant, and high-quality datasets that reduce the risk of costly regulatory delays, while accelerating the speed and efficiency of developing and bringing drugs to market.

It is the same tool used by the FDA and Japan’s PMDA to review the quality of submissions.

● Scientific Informatics Platform (D360) :

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

We estimate that more than 6,000 discovery research scientists worldwide use D360.

● Clinical Outcomes Databases for Biosimulation (CODEx) :

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The databases cover more than 10,000 clinical trials and observational studies and are accessible via an online portal with analytical and visualization tools.

In 2020, we introduced a new CODEx database for COVID-19.

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

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Customers use our software to communicate the value of a new therapy to payors and providers to gain formulary acceptance and reimbursement.

Technology-Enabled Services

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

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

Our technology-enabled services include integrated drug development services include mechanistic biosimulation, empirical biosimulation, drug development and regulatory writing and medical communications, regulatory operations, and market access.

Regulatory agencies promote and endorse the use of biosimulation in drug development as “model informed drug discovery and development,” which integrates our software and technology-enabled services to inform key decisions during drug discovery, development, approval, and subsequent market access.

Technology-Driven Services

Our technology-driven, biosimulation services help 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.

Our technology-driven services include integrated drug development services include mechanistic biosimulation, empirical biosimulation, drug development and regulatory writing and medical communications, regulatory operations, and market access.

Regulatory agencies promote and endorse the use of biosimulation in drug development as “model informed drug discovery and development,” which integrates our software and technology-driven services to inform key decisions during drug discovery, development, approval, and subsequent market access.

● Mechanistic Biosimulation:

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● Model-Based Meta-Analysis:

We utilize curated clinical trial data from our CODEx clinical outcomes database platform together with model-based meta-analysis to assess a new drug’s safety and efficacy in relation to competitive products.

We utilize curated clinical trial and real-world data from our CODEx clinical outcomes database platform together with model-based meta-analysis to assess a new drug’s safety and efficacy in relation to competitive products.

● Regulatory Writing and Medical Communications:

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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 EMA, Health Canada, Japan’s PMDA, and China’s NMPA.

● Market Access:

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These services include conducting real-world evidence and health economics outcomes research, delivering value and access consultancy solutions, creating cost and comparative effectiveness models to support pricing and payor reimbursement, and collecting and analyzing real-world data for use in market and payor communications.

We use our proprietary technology called the Health Outcomes Performance Estimator (HOPE), based on a Bayesian engine, that translates clinical trial findings and population health knowledge into expected real-world impact.

Sales and Marketing

Our sales and marketing functions pursue a coordinated approach with a global commercial team of business development, product management, and marketing experts.

Our global commercial team collaborates with our scientists, subject matter experts, and technologists to engage with customers and prospects to understand their needs and offer tailored solutions with our biosimulation software and technology-enabled services.

Our scientists and experts have authored thousands of scientific publications, posters, and articles to share biosimulation knowledge and methods to advance adoption.

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

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

In 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 biosimulation software 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-enabled services generally compete with companies significantly smaller than ourselves, such as Nuventra, Metrum Research Group, and Simulations Plus.

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.

We also face competition in this space from in-house teams at biopharmaceutical companies and academic and government institutions.

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

We generally compete in the technology-enabled 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 attractive to customers, and price, amongst 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.

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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.

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We also maintain a portfolio of issued and pending patents in several of jurisdictions in which we do business.

As of December 31, 2020, our patent portfolio consisted of 29 issued patents and nine pending patent applications related to our software and technology.

The Company does not currently consider any of its issued patents to be material to its business.

As of December 31, 2021, our patent portfolio consisted of 26 issued patents and 7 pending patent applications related to our software and technology.

We do not currently consider any of our issued patents to be material to our business.

Several of our most recently filed patent applications relate to our liquid biopsy project, and describe a method of gleaning information from a simple blood test that can be used to predict and optimize how that individual patient will absorb and metabolize a drug, thereby allowing a clinician to determine the optimal dosing of a drug on an individual basis.

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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, Virtual Twin, WinNonlin, and BaseCase.

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.

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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 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.

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.

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

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

For example, the 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.

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.

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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 CJEU invalidated the Privacy Shield under which personal data could be transferred from the EEA to U.S.

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.

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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 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.

17 unchanged sentences

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.

These filings are also available for download free of charge through a link on our Investor Relations website.

The SEC also maintains an Internet website at www.sec.gov that contains reports, proxy statements and other information about issuers, like us, that file electronically with 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).

These documents are also available for download free of charge through a link on our Investor Relations website.

The SEC also maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information about reporting issuers, like us, that file electronically with the SEC.

Our internet website and the information contained therein or connected to or linked from our internet web site are not incorporated information and do not constitute a part of this Annual Report.

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