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.
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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 |
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Disclaimer
Simulations Plus Inc. published this content on 20 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2024 22:26:01 UTC.