Simulations Plus : SLP Investor Presentation Q2FY24

Investor Presentation

NASDAQ: SLP

Q2 FY24 Update

Safe Harbor Statement

With the exception of historical information, the matters discussed in this presentation are forward-looking statements that involve a number of risks and uncertainties. Words like "believe," "expect" and "anticipate" mean that these are our best estimates as of this writing, but that 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 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, our ability to successfully integrate the recently acquired Immunetrics business with our own, as well as expenses we may incur in connection therewith, 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.

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Mission: Improve Health Through Innovative solutions​

To create value for customers

by accelerating development timelines and reducing the cost of drug development R&D through innovative science-based software and consulting solutions that optimize treatment

options and improve patient lives.​

3

OVER

SLP At A Glance

Leading Provider of Software and Consulting Services in the Biosimulation Market

AI-powered technology solutions optimize the outcomes of drug discovery, development, research, and regulatory submissions processes. Our software-based technology both models and simulates how drugs and diseases behave in humans and in other species.

25+

YEARS

300+

CLIENTS

18+

SOFTWARE

SOLUTIONS

25 YEARS IN BUSINESS AND CONTINUING THE COMMITMENT TO IMPROVE PUBLIC HEALTH THROUGH INNOVATIVE SOLUTIONS

OUR CLIENTS TRUST OUR EXPERT CONSULTING THAT SUPPORTS DRUG RECOVERY, CLINICAL DEVELOPMENT RESEARCH AND REGULATORY SUBMISSIONS

WE PROVIDE VALIDATED AI AND MACHINE LEARNING, MODELING AND SIMULATION SOFTWARE FOR NOVICE AND EXPERT USERS ALIKE

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Investment Highlights

+

Industry Leader

in Large and Growing

Market

+

Strong Competitive

Position and Barriers

to Entry

++

Biosimulation	Compelling
Technology Leader	Customer Value
Leveraging AI	Proposition

++

	Seasoned
Attractive	Management Team
Financial Profile	and Scientific
	Leadership

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Biosimulation Overview ​

Biosimulation is software-based technology that models and simulates how drugs and diseases

behave in the human body​

Biosimulation combines core principles in biology, chemistry and pharmacology with proprietary mathematical algorithms

to predict how biology and drugs interact with one another.​

• Models can start in vitro (without animal or human testing) but are developed through the development cycle incorporating animal and
  human test results along the way.​
• Model uses include lead optimization, dose regimens, clinical trial protocol development, clinical trial simulation, bioequivalence
  evaluation, toxicity assessment and many more.

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Drug Development Challenges | Biosimulation Solution​

Our core mission - accelerating the development and delivery of better, safer, and more effective drugs

CHALLENGES		SIMULATIONS PLUS SOLUTIONS

• The median cost of developing a new drug averages $1.5 to $2 billion and the timeline can range from 10-15 years.​
• On average only 11% of all drug candidates are approved​

• Simulations Plus offers AI-powered technology solutions to help optimize the outcomes of the drug discovery, development, research and regulatory approval processes to bring drugs to market faster
• Simulations Plus solutions can help increase the number of candidates approved by streamlining thedrug development process, creating efficiencies that lead to drug efficacy and safety, higher regulatory approval, improved commercial success​ and much more

Source: Company research​

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Leader in Large and Growing Market​

Spending for biosimulation products continues to increase given need to bring drugs to market faster​

$200B GLOBAL PHARMA

AND BIOTECH SPEND (3% CAGR)1

$9.8B BIOSIMULATION1

TAM BY 2030​

$700M-$800M

SLP ADDRESSABLE

• Biosimulation market valued at $2.8B in 2022 and
  is expected to expand at a 16.9% CAGR from 2022 - 20301
• Strategy to grow addressable market within the Biosimulation TAM through both internal R&D investment and strategic acquisitions​​​
• • Biosimulation TAM growing 4-5x faster than global pharma and biotech spend
  • SLP is growing faster than the Biosimulation TAM ​
• Highly fragmented and underpenetrated market with only a few larger players
• • The global biosimulation market is segmented based on product, application, delivery model, and end users.

1 Company research, SkyQuest

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Compelling Customer Value Proposition ​

• GastroPlus®​
• ADMET Predictor®​
• MonolixSuite (includes Monolix, Pkanalix, Simulix)​
• QSP/T Models (including DILISYM,
  RENASYM, IPFSYM, etc.)​

• Provides operational efficiencies and leads to accurate / timely decision making and regulatory reporting

Wide range of software	Solutions offerings span
solutions and consulting	the drug development
services	process

HIGHLY EXPERIENCED SALES

TEAM SUPPORTED BY

SCIENTISTS AND

ENGINEERS

Saves time and

money in drug development	Proven model
improves probability
costs, improves likelihood
and speed of clinical
of success and post
trial success
approval returns​

• Early drug discovery to preclinical
• Clinical data analysis
• Submission to regulatory agencies supporting product approval

• Only ~7% of proposed new drug compounds pass Phase I trials
• Only 53% of drugs that get to Phase III trials make it to market
• 70% of drugs fail in Phase II or Phase III due to safety and efficacy issues

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End-to-End Solutions Across the Development Life Cycle

Decrease development uncertainty, cost and time

CONFIDENCE LEVEL OF DRUG APPROVAL

CHEMINFORMATICS

PBPK / PBBM/ QST/ QSP

PHARMACOMETRICS

REGULATORY

DRUG

APPROVAL

"…combining models and data

results in higher confidence in clinical performance at an earlier

time in development."

U.S. Food and Drug Administration

Discovery	Pre-clinical	Clinical	Drug Approval

TIME	10