Fairmount Partners Advises Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data, in its Pending Acquisition by Certara

Transaction accretive to Certara’s revenue, adjusted EBITDA, and adjusted EPS, subject to closing

PRINCETON, NJ – August 5, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock.  Pinnacle 21’s software tools are used to validate compliance to the Clinical Data Interchange Standards Consortium (CDISC) standards, which is required by the US FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for drug submissions and preferred by China’s National Medical Products Administration (NMPA).

“We are excited to welcome Pinnacle 21 to Certara as we execute on our strategy to invest in innovation to increase the use cases of biosimulation and grow adoption of our end-to-end platform,” said William F. Feehery, Ph.D., CEO of Certara.  “The complementary acquisition of Pinnacle 21 marks an important expansion of Certara’s biosimulation and regulatory software and technology-driven services.  The fuel for biosimulation, machine learning and statistics is high-quality, standardized data. Pinnacle 21 is a leader in biopharmaceutical data fitness, which streamlines quantitative analyses needed by our clients. This addition to our business creates compelling opportunities as we integrate and expand our complementary offerings.”

The acquisition will immediately establish Certara as a central participant in the data standardization process across the entire drug development life cycle. Data standards are complex and increasingly challenging to adhere to as the volume of data in clinical trials increases with the globalization of the biopharmaceutical industry and the growth of wearables and other health technologies.  High-quality, standardized data are needed for efficient and precise analyses.  Pinnacle 21’s proprietary validation software 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 lifesaving drugs to market.

“Certara is the ideal partner for Pinnacle 21’s exceptional team and customer base,” said Max Kanevsky, Founder and CEO of Pinnacle 21. “Both companies empower customers to collect, validate, and analyze data to inform critical decisions in drug development and achieve regulatory success. Joining forces with Certara tightens the link between clean data and informed analysis. We are eager to integrate and expand our software platforms to continue our mission to speed up lifesaving therapies to patients.”

Pinnacle 21 is driving the market for data validation software, particularly for clinical trials, with more than 130 Pinnacle 21 Enterprise customers, including 22 of the top 25 biopharmaceutical companies by R&D spend, as well as the FDA and PMDA. There are also more than 1,000 organizations using its open-source Community software. 

Key Transaction Terms

The enterprise value of the transaction is $310 million, with Pinnacle 21 shareholders receiving $250 million in cash consideration and $60 million in Certara shares. Following closing, the transaction will be immediately accretive to Certara’s adjusted EPS. The transaction is expected to be accretive to Certara’s revenue, adjusted EBITDA, and adjusted EPS growth rates.

Fairmount Partners, a leading middle-market investment bank in the technology industry, served as the exclusive financial advisor to Pinnacle 21 on the transaction. Fairmount worked closely with Pinnacle 21’s founder for over two years to help develop the company’s strategy and positioning prior to taking Pinnacle 21 to market in a process that culminated with the Certara transaction.

About Certara

Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.

About Pinnacle 21

Pinnacle 21 is a global leader in software for preparing clinical trial data for regulatory submission. Pinnacle 21’s platform validates data quality and compliance with CDISC standards, enabling a clean data pipeline from worldwide sponsors to health authorities, including the FDA, PMDA and NMPA.  Streamlined approvals bring life-saving medicines to patients faster.

About Fairmount Partners

Fairmount Partners (www.fairmountpartners.com) is an independent merger and acquisition advisory firm focused on emerging growth and middle-market companies. Fairmount helps its clients complete mergers and acquisitions, raise funds for growth, acquisitions and liquidity, and design and improve their corporate development strategies. Fairmount’s clients include successful entrepreneurs, private equity-sponsored enterprises, and global public companies. Since 2003, Fairmount has completed more than 250 transactions, representing over $13 billion in aggregate value, in 20 countries throughout North and South America, Europe, Asia and Australia. For further information, please contact:

Charles Robins

Managing Director

(610) 260-6431

Charles.Robins@FairmountPartners.com

Roger Christopher

Director

(610) 260-6269

Roger.Christopher@FairmountPartners.com