Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024

Rhea-AI Summary

Simulations Plus (Nasdaq: SLP) announced its significant impact on pharmaceutical development, revealing that its technology supported the majority of FDA-approved drugs in 2024. The company's comprehensive suite of solutions includes artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), and quantitative systems pharmacology/toxicology (QSP/QST) modeling approaches.

CEO Shawn O'Connor emphasized the company's 25-year track record in providing mission-critical software and services for therapy development. SLP's offerings encompass drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization support, demonstrating their integral role in advancing global healthcare solutions.

Positive

• Supported development of majority of FDA-approved drugs in 2024
• Diverse portfolio of advanced technological solutions including AI/ML
• Established 25-year industry presence in pharmaceutical development

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The announcement that Simulations Plus supported the development of most FDA-approved drugs in 2024 represents a pivotal market position achievement. The company's comprehensive suite of AI/ML-powered modeling and simulation tools has become integral to the drug development pipeline, effectively reducing both time and costs in the pharmaceutical development process.

From a competitive standpoint, this level of market penetration creates significant barriers to entry for potential competitors. By being involved in the majority of FDA approvals, SLP has established itself as the de facto standard in pharmaceutical modeling and simulation - a position that typically leads to strong recurring revenue streams and high customer retention rates.

The company's diverse portfolio spanning AI/ML, PBPK/PBBM and QSP/QST modeling approaches positions it uniquely at the intersection of traditional pharmaceutical research and cutting-edge technology. This technological diversification helps insulate the company from shifts in any single approach while capturing growth across multiple industry trends.

Technology Research Analyst

The integration of AI/ML capabilities in SLP's suite of solutions represents a significant technological moat. Their adaptive learning systems, combined with traditional modeling approaches, create a self-reinforcing data advantage - each successful drug development process enhances their models' accuracy and predictive capabilities.

In simpler terms, think of it as a GPS system that becomes more accurate with each journey - the more drugs developed using their platform, the more valuable and accurate their system becomes for future drug development. This network effect is particularly powerful in the highly regulated pharmaceutical industry, where accuracy and reliability are paramount.

Looking ahead, this positions SLP favorably in the rapidly growing biosimulation market, especially as the industry moves towards more complex biologics and personalized medicine approaches that require sophisticated modeling capabilities.

SLP’s technology and expertise accelerates drug development and supports critical advancements in global healthcare

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today highlighted its impact on the pharmaceutical industry through supporting the development of a majority of the drugs approved by the U.S. Food and Drug Administration (FDA) in 2024.

“For more than 25 years, our clients have entrusted us to provide the mission-critical software and services needed to develop therapies that are changing the landscape of healthcare,” said Shawn O’Connor, Chief Executive Officer at Simulations Plus. “We are proud that our advanced modeling and simulation software and consulting services supported the development of the majority of drugs approved by the FDA in 2024. This achievement underscores the increasing role that innovative technologies and collaborative expertise plays in accelerating the drug development process. As global health challenges grow, we remain committed to delivering solutions which help advance life-saving therapies that improve patient outcomes worldwide.”

Simulations Plus offers software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. SLP’s suite of solutions leverage artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/physiologically based biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/quantitative systems toxicology (QSP/QST), and population PK/PD modeling approaches, as well as adaptive learning and medical communications tools.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized 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.

Environmental, Social, and Governance (ESG)

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, please visit our website to read our 2023 ESG update.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those 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, as well as expenses we may incur in connection therewith, the efficiency and effectiveness of our internal business restructuring and leadership changes, our ability to maintain our competitive advantages, 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 staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250113170308/en/

Financial Profiles

Lisa Fortuna

310-622-8251

slp@finprofiles.com

Source: Simulations Plus, Inc.

FAQ

How many FDA-approved drugs in 2024 were developed using Simulations Plus (SLP) technology?

According to the press release, Simulations Plus supported the development of the majority of FDA-approved drugs in 2024, though the exact number was not specified.

What technologies does Simulations Plus (SLP) use for drug development?

SLP uses AI/ML, PBPK/PBBM, QSP/QST, population PK/PD modeling approaches, adaptive learning, and medical communications tools.

What services does Simulations Plus (SLP) offer to pharmaceutical companies?

SLP offers software and consulting services for drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization.

How long has Simulations Plus (SLP) been operating in the pharmaceutical industry?

According to the press release, Simulations Plus has been operating for more than 25 years in the pharmaceutical industry.