Simulations Plus optimizes business unit structure to support future growth following recent strategic acquisitions

Announces appointments for management positions in newly established business units

LANCASTER, Calif.–(BUSINESS WIRE)–Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence, and medical communications solutions for the biopharmaceutical industry, today announced the optimization of its business unit and leadership structure to support future growth following the company’s recent acquisitions, effective August 30, 2024.

“Over the past year, we have made two key acquisitions, including the largest in our company’s history,” said Shawn O’Connor, CEO. “As a result, we have doubled our total addressable market, developed a first-of-its-kind platform, and significantly strengthened our talent pool. As we integrated Pro-ficiency into our platform, we identified synergies and opportunities to realign our business units and leadership structure to better serve our customers and maximize our growth opportunities. Above all, our expanded team of top industry talent is united by our shared mission to create value for our customers by accelerating the discovery and delivery of medicines to patients.

“When bringing Pro-ficiency on board, we focused on effectively optimizing people and resources. As a result, we are creating two new and distinct business units—Adaptive Learning & Insights and Medical Communications—to increase engagement with our current and prospective customers. We are also moving the Regulatory Strategies business unit to the new Regulatory Strategies Center of Excellence. This change is expected to increase visibility across the sales organization and accelerate cross-selling opportunities driven by the growing demand for biosimulation solutions.

“Our suite of comprehensive and innovative offerings now spans the drug development continuum, which we believe uniquely positions Simulations Plus to scale the business to drive growth and profitability. As we look ahead, we are excited about the potential we see to create long-term value for all of our stakeholders.”

Simulations Plus has announced the following promotions and management changes:

Steven Chang will be promoted to President, Quantitative Systems Pharmacology. Mr. Chang joined Simulations Plus in June 2023 following the acquisition of Immunetrics and has served as President and CEO since 2002. He is a successful technology entrepreneur with over three decades of experience in identifying emerging market needs and combining cutting-edge technologies and resources to address those needs.

Jenna Rouse will be promoted to President of the newly formed Adaptive Learning & Insights business unit. Ms. Rouse joined Simulations Plus following the acquisition of Pro-ficiency, where as Chief Markets Officer, Clinical, she spent five years leading the development and engagement of the organization’s simulation-based training solutions to optimize clinical trials, competency development, and continuing medical education. Prior to joining Pro-ficiency, she spent 25 years in workforce development in regulated industries, with more than 15 years focused on professional development and adult learning in clinical trials.

Murry Alper will be promoted to President of the newly formed Medical Communications business unit. Mr. Alper joined Simulations Plus following the acquisition of Pro-ficiency. Mr. Alper brings nearly 30 years of experience in the life sciences industry, with both major development firms and on the agency side. Mr. Alper founded Caravel Group in 2006 after a decade in marketing and sales roles at Bristol-Myers Squibb and Genentech. He co-founded multiple medical communications agencies and was Managing Partner of Compass Group Partners following its acquisition by Pro-ficiency in June 2023.

Sandra Suarez-Sharp, Ph.D. will transition to the role of President of the Regulatory Strategies Center of Excellence. Dr. Suarez-Sharp joined Simulations Plus in 2020 and has played a key role in facilitating the company’s regulatory support to its clients. Prior to joining Simulations Plus, Dr. Suarez-Sharp had a long and successful career in the Food and Drug Administration, including roles in biopharmaceuticals, bioequivalence, and clinical pharmacology. In her new role, she is responsible for expanding the Regulatory Strategies Center of Excellence to accelerate cross-selling opportunities driven by the rapidly growing demand for biosimulation solutions.

The company also announced the following departures:

Brett Howell, Doctorate, President, Quantitative Systems Pharmacology and Michael RaymerPresident of Clinical Simulations and Medical Communications, to leave Simulations Plus after helping with transition process.

O’Connor concluded, “We are grateful for Dr. Howell’s leadership and contributions to the company. Under his leadership, our QSP business has achieved remarkable milestones since the acquisition of DILIsym in 2017. Additionally, Mr. Raymer played a key role in the acquisition and initial integration of Pro-ficiency. We wish them both the best in their future endeavors.”

About Simulations Plus

With over 25 years of experience serving clients worldwide, Simulations Plus is a leading provider in the biopharmaceutical sector, offering advanced software and consulting services that streamline drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate AI/machine learning (AI/ML), Physiology-Based Pharmacokinetics, Physiology-Based Biopharmaceuticals, Quantitative Systems Pharmacology/Toxicology, and Population PK/PD Modeling Approaches. We also provide simulation-enhanced performance and intelligence solutions, as well as medical communication support for clinical and commercial drug development. Our cutting-edge technology is licensed and used by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

Environment, Society and Corporate Governance

We focus our environmental, social and governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, visit our website to read our 2023 ESG Update.

Forecast statements

Other than historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words such as “believe,” “expect” and “anticipate” mean that these are our best estimates as of the date of writing, but no assurance can be given that the expected or anticipated results or events will actually occur, so our actual future results may differ materially from these statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to successfully integrate the Pro-ficiency business with our own and the expenses we may incur in connection therewith, the effectiveness and efficiency of our internal business restructuring and management changes, our ability to maintain our competitive advantages, the acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical personnel, market conditions, macroeconomic factors and market sustainability. Further information about our risk factors is included in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

Communication

Investor Contacts:

Lisa Fortuna

Financial profiles

310-622-8251

[email protected]

Renée Bouche

Simulations Plus Investor Relations

661-723-7723

[email protected]