8-K
Simulations Plus, Inc. (SLP)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
July 7, 2023
(Date of the earliest event reported)
Simulations Plus, Inc.
(Exact name of registrant as specified in its charter)
| California | 001-32046 | 95-4595609 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
42505 10th Street West, Lancaster, California 93534-7059
(Address of principal executive offices) (Zip Code)
661-723-7723
Registrant's telephone number, including area code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | SLP | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Emerging Growth Company | ☐ |
|---|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 Regulation FD Disclosure
Simulations Plus, Inc., a California corporation (the “Company”), will be participating at an investor conference hosted by BTIG from July 11, 2023 to July 13, 2023. A copy of the investor presentation that will be utilized at the conference is attached to this Current Report on Form 8-K (this “Report”) as Exhibit 99.1. The presentation has also been posted to the Company’s website in the “Investors” section.
In accordance with General Instructions B.2 of Form 8-K, the information in this Report, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This Report, including the disclosures set forth in Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Report or reports hereafter furnished, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), to the Company’s stockholders and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| 99.1 | Simulations Plus Investor Presentation – Q3 FY23 |
|---|---|
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| SIMULATIONS PLUS, INC. | |
|---|---|
| Dated: July 7, 2023 | By: /s/ Will Frederick |
| Will Frederick | |
| Chief Financial Officer |
2
simulationsplusinvestorp
Investor Presentation NASDAQ: SLP Q3 FY23 Update
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. Safe Harbor Statement 2
Mission: Improve health through innova ve solu ons 3 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 op ons and improve pa ent lives.
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 OVER 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 300+ CLIENTS WE PROVIDE VALIDATED AI AND MACHINE LEARNING, MODELING AND SIMULATION SOFTWARE FOR NOVICE AND EXPERT USERS ALIKE 18+ SOFTWARE SOLUTIONS BUSINESS OVERVIEW PLATFORM FINANCIAL HIGHLIGHTS FY23 NINE MONTHS Software ~65% Services ~35% >10 years profit / rev growth 150+ Highly Experienced Employees ~70 scien fic PhDs 1,300 publications 90%+ Software Fee Renewal Rate Customers include leading pharma, biotech, and CPG companies, global regulatory agencies Most comprehensive and widely recognized tools for MIDD Innovative, science-based software AI-driven | Machine-learning platforms Full scale, customizable services brings therapeutic, modeling and regulatory knowledge and resources to clients Solutions span the drug development process $43.9M (+4%) Total Revenue $9.4M Net income $0.46 DEPS 81% Gross margin $15.7M Adj EBITDA 36% Margin $122.4M in Cash and Short- Term Investments No Debt 4 SLP At a Glance
Investment Highlights Industry Leader in Large and Growing Market Biosimulation Technology Leader Leveraging AI Compelling Customer Value Proposition 5 Strong Competitive Position and Barriers to Entry Seasoned Management Team and Scientific Leadership Attractive Financial Profile +++ +++
Biosimula on Overview 6 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. + +
Drug Development Challenges | SLP Biosimula on Solu on 7 Biosimulation increasingly gaining importance in drug development SIMULATIONS PLUS SOLUTIONS Simulations Plus offers AI-powered technology solutions to help optimize the outcomes of the drug discovery, development, research and regulatory approval processes Biosimulation has helped pharmaceutical, biotech and other companies bring drugs to market faster and significantly reducing R&D spend Simulations Plus solutions can help increase the number of candidates approved by streamlining the drug development process, creating efficiencies that lead to drug efficacy and safety, higher regulatory approval, improved commercial success and much more CHALLENGES Drug Development is expensive and time intensive 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 Source: Company research – – + +
Leader in Large and Growing Market 8 Spending for biosimula on products con nues to increase given need to bring drugs to market faster Biosimulation market valued at $2.4B in 2021 and is expected to expand at a 16.9% CAGR from 2022 - 2030 Strategy to grow addressable market within the Biosimulation TAM through both internal R&D investment and strategic acquisi ons • SLP is growing faster than the Biosimulation TAM at 17.4% per year • Biosimulation growing at 4-5x total R&D spend 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, Grandview Research $200B GLOBAL PHARMA AND BIOTECH SPEND (3% CAGR)1 + + + $9.8B BIOSIMULATION1 TAM BY 2030 $700M-$800M SLP ADDRESSABLE
Secular Trends Driving Sustained Long-Term Growth Biosimulation taking greater percentage of drug development spend annually Scarcity of blockbuster drug opportunities drive industry focus to smaller market targets requiring increased development efficiency Increased scrutiny and rising cost of animal studies and human clinical Increased adoption of Modeling & Simulation by regulatory agencies and decision making based on Modeling & Simulation input Increasing use cases for application of Modeling & Simulation methods to impact decision making 9 Drivers include: + + + + +
Compelling Customer Value Proposi on 10 Wide range of software solutions and consulting services Solutions offerings span the drug development process Saves time and money in drug development costs, improves likelihood of success and post approval returns Proven model improves probability and speed of clinical trial success SOLUTIONS INCLUDE: • Early drug discovery to preclinical • Clinical data analysis • Submission to regulatory agencies suppor ng product approval • 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 repor ng • 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 HIGHLY EXPERIENCED SALES TEAM SUPPORTED BY SCIENTISTS AND ENGINEERS
Drug Discovery & Development 11 The Drug Discovery and Development Industry can be broken down into several subindustries, including: 1. TARGET DISCOVERY AND VALIDATION 2. LEAD COMPOUND IDENTIFICATION AND OPTIMIZATION 3. PRE-CLINICAL DEVELOPMENT 4. CLINICAL TRIALS 5. REGULATORY REVIEW & APPROVAL 6. COMMERCIALIZATION 7. POST-APPROVAL SURVEILLANCE AND LIFE CYCLE MANAGEMENT Each of these subindustries represents a different stage of the drug development process and involves different tasks, such as identifying targets for drug development, synthesizing and testing compounds, conducting clinical trials, and seeking regulatory approval for marketing and sales. The subindustries within drug discovery and development are highly interdependent, with progress in one stage o en impac ng the progress in other stages.
Offers End-to-End Solutions Across the Development Life Cycle 12 Decrease development uncertainty, cost and time CO N FI D EN CE LE VE L O F D RU G A PP RO VA L TIME DRUG APPROVAL Discovery Pre-clinical Clinical Drug Approval CHEMINFORMATICS PHARMACOMETRICS PBPK / PBBM/ QST/ QSP “…combining models and data results in higher confidence in clinical performance at an earlier time in development.” U.S. Food and Drug Administration
Strong Compe ve Posi on 18 LEADING POSITION IN LARGE, GROWING, FRAGMENTED AND UNDERPENETRATED MARKET LARGE, GROWING AND DIVERSE CUSTOMER BASE MOST COMPREHENSIVE AND WIDELY RECOGNIZED TOOLS IN THE INDUSTRY 300+ CUSTOMERS ACCUMULATED PUBLIC AND PRIVATE DATA THAT INFORMS OUR ALGORITHMS AND MODELS 13 + + + + +
Attractive Financial Profile 14 Delivering Double-Digit Revenue Growth / Industry Leading Margins REVENUE $ in millions $24.1 $29.7 $34.0 $41.6 $46.4 $53.9 17.4% GROSS MARGIN % EBITDA MARGIN % FY17 FY18 FY19 FY20 FY21 FY22 5 Yr CAGR FY17 FY18 FY19 FY20 FY21 FY22 6 Yr Avg 73.9% 73.1% 73.4% 74.4% 77.2% 79.9% 75.3% 43.1% 43.3% 39.1% 34.4% 31.2% 33.3% 37.4% Double-digit revenue growth Strong recurring revenue supported by a 90%+ Software Fee Renewal Rate High gross/EBITDA margins to drive strong opera ng leverage High-margin, recurring revenue over the life of the customer rela onship Product mix skews toward higher margin software sales $122.4 million in cash and short- term investments to fund growth + + + + + +
Immunetrics Acquisition | June 2023 15 Increases breadth and depth of QSP expertise and range of therapeutic applications Rationale Terms ▪ Immunetrics is a M&S company focused on accelerating drug development in oncology, immunology, and autoimmune diseases ▪ Increases offering areas among the fastest growing therapeutics ▪ Strengthens the already-robust quantitative systems pharmacology (“QSP”) expertise at Simulations Plus ▪ QSP is a rapidly growing field of biomedical research ▪ Expands the range of therapeutic areas addressed by its software and services ▪ Increases the therapeutic areas addressed by Simulations Plus QSP models by more than 50% ▪ Leverages existing infrastructure by expanding therapeutic resources into largely underserved areas, including immunology and oncology ▪ Paid Immunetrics shareholders cash consideration of $15.5 million (includes $1.8 million hold-back) ▪ Two future earn-out payments in the aggregate amount of up to $8 million, based on revenue performance through December 31, 2024
Disciplined Capital Allocation Strategy 15 ORGANIC GROWTH INITIATIVES DISCIPLINED ACQUISITION STRATEGY WITH HISTORY OF ACCRETIVE ACQUISITIONS • Expanding business development and sales team to meet client demand and growing adop on of biosimula on so ware • Expanding local coverage of EU markets • Supporting accelerated growth in distributor network • New customer growth in U.S., Europe, Asia • Expand small/mid-sized biotech client base • Executing on key accounts and cross selling products and services • R&D spend rate to extend technology capabilities and continuous algorithm/model improvement JUNE 2017 DILIsym Services, Inc. SEPTEMBER 2014 Cognigen Corp. + + APRIL 2020 Lixoft JUNE 2023 Immunetrics DIVIDEND SHARE REPURCHASE PROGRAM $50 million share repurchase program announced in January 2023 Consistently paid $0.06 per share dividend per quarter + + ASR completed in 3Q23 with 492,041 shares retired at an average cost per share of $40.65.
Seasoned Management Team and Scien fic Leadership 18 Shawn O’Connor Chief Executive Officer Will Frederick Chief Financial Officer Brett Howell, Ph.D. President, DILIsym Services Jill Fiedler-Kelly, M.S., F.I.S.oP. President, Cognigen John DiBella, M.S President, Simulations Plus Jonathan Chauvin, Ph.D. President, Lixoft Josh Fohey VP, Business Development Highly experienced management team with deep life science industry expertise, track record of growth and strong returns
Dedicated to ESG 19 Strategic priorities that align with our mission and values and the four pillars of sustainability ENVIRONMENT SOCIAL HUMAN CAPITAL GOVERNANCE Reduced exposure to humans and animals by advancing in silico simulation analyses for chemical safety assessment programs Supported academic research by partnering with universities and donating free software licenses to support academic research and training Funded awards and post doctoral research to support education Expand our HR team and capabilities in 2020 with special focus on training and development Focused on diversity and inclusion with over 39% of our employees from minority backgrounds Implemented a new flexible vacation policy by augmenting the 11 paid holidays for our U.S. employees with no annual limit provided employee duties and obligations are met Advanced growing acceptance of technology by developing collab- orations with universities, research organizations, distributors, and government agencies (FDA & NIH) Created a new corporate data protection officer to standardize and advance our company-wide Data Protection & Customer Privacy framework Strengthened our business ethics program by implementing a new unified Corporate code of Business Conduct and Ethics, thereby replacing separate policies currently in effect at our divisions Committed to renewable energy with our Lancaster Choice Energy Smart Choice 100% renewable energy program Optimized our data centers by reducing the number of physical servers in our Buffalo, NY data center from 140 units to just 60 units Implemented business recycling efforts to reduce our environmental footprint and pursue responsible business practices
WELL POSITIONED TO ACHIEVE OUR FY23 GOALS Delivering on our commitment to scientific leadership Challenges being addressed 19 • Internal R&D investment • Expanding industry and regulatory partnerships • MIDD+ – 3rd annual SLP sponsored conference Enhancing our client facing capabilities Focus on Capital Allocation CONTINUED LEADERSHIP POSITION IN BIOSIMULATION MARKET Conclusion • Growth and maturity of business development team • Focus on expanding our local coverage of EU market • Focus on supporting accelerated growth in distributor network • Software renewal timing changes on track • Small biotech churn • General market dynamics: inflation, recession & forex • ASR program has been completed • Immunetrics acquisition completed in Q4
Appendix 20
SLP software licensed to major pharma (19 of 20 largest) GastroPlus - mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal, subcutaneous, and intramuscular absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals. ADMET Predictor - the flagship machine learning platform for ADMET modeling with extended capabilities for data analysis, metabolism prediction, and AI-driven drug design. DILIsym is Quantitative Systems Toxicology (QST) - software designed to be used during drug development to provide an indication of the potential drug-induced liver injury (DILI) hazard posed by individual molecules and/or to provide deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process. MonolixSuite - built for model-informed drug development computing, MonolixSuite (including Monolix, Slmulix, Pkanalix) is a fast, easy-to-use, and powerful suite of applications for pharmacometrics analysis, modeling, and simulation. Intui ve, effec ve offering the most advanced calcula on capabili es . QSP/T Models • ILDsym - model of interstitial lung disease (ILD) associated with systemic sclerosis (SSc). • RENAsym is quantitative systems toxicology (QST) software for predicting and understand drug-induced kidney injury. So ware Products Overview 21 Biosimulation Technology Leader Leveraging AI and Machine Learning + + + + + +
PBPK Software Solutions and AI Data 22 LEAD SELECTION PHARMACOLOGY TREATMENT REGIMEN SAFETY CLINICAL EFFICACY ADMET DMPK SERVICES PBPK / PBBM Preclinical Regulatory Consulting
QSP/QST Solu ons Mining 23 LEAD SELECTION PHARMACOLOGY TREATMENT REGIMEN SAFETY CLINICAL EFFICACY ADMET DMPK SERVICES QSP Consulting QST Consulting
Pharmacometrics Solu ons 24 LEAD SELECTION PHARMACOLOGY TREATMENT REGIMEN SAFETY CLINICAL EFFICACY ADMET DMPK SERVICES Pharmacometrics Clinical Pharmacology Clinical Regulatory Consul ng
Services Overview 25 Provides customers with specialized knowledge and exper se Delivers complementary capabili es to so ware applica on solu ons • Drives greater demand for its so ware solu ons • Provides stable, steady revenue streams Helps clients minimize or eliminate questions posed by regulatory reviews while decreasing cost and time to develop detailed reports Drives operational efficiencies for customers leading to timelier and more streamlined decision-making and regulatory reporting Covers Pharmacometrics, PBPK, QSP/T and Regulatory Strategies disciplines Offers specialized therapeutic, modeling and regulatory knowledge Brings specialized knowledge and expertise as part of its consulting services, helping extend customers’ internal capabilities in the biosimulation modeling and the simulation space Average contract size of approximately ~$200k • Pharmacokinetic and Pharmacodynamic (PKPD) projects in the $100K - $300K range • Quantitative Systems Technology (QST) and Quantitative Systems Pharmacology (QSP) platform contracts can be in the $300K - $700K range • Customer contracts are sizable and provide steady revenue streams + + + + + + + +
