8-K - SLP - Equibles

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

March 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

On March 7, 2023, Simulations Plus, Inc., a California corporation (the “Company”), will present at the Raymond James 44th Annual Institutional Investors Conference using the presentation attached to this Current Report on Form 8-K (the “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	Raymond James 44th Annual Institutional Investors Conference Presentation, March 7, 2023
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: March 7, 2023	By: /s/ Will Frederick
	Will Frederick
	Chief Financial Officer

slpinvestorpresentation-

Investor Presentation NASDAQ: SLP Q1 FY23 Update

NASDAQ: SLP2 With the exception of historical information, the matters discussed in this presentation are forward-looking statements that involve a number of risks and uncertainties. The actual results of the Company could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: continuing demand for the Company’s products, competitive factors, the Company’s ability to finance future growth, the Company’s ability to produce and market new products in a timely fashion, the Company’s ability to continue to attract and retain skilled personnel, and the Company’s ability to sustain or improve current levels of productivity. Further information regarding the Company’s risk factors is contained in the Company’s quarterly and annual reports filed with the Securities and Exchange Commission. Safe Harbor

NASDAQ: SLP3 About Us Leading provider of modeling and simulation software and services used by major pharmaceutical, biotech, and regulatory agencies worldwide to make better model-informed data-driven decisions (MIDD). >150 Employees >10 yrs Profit/rev growth >250 Clients >90% Client Retention >70 Scientific PhDs 1300 Publications Founded in 1996

NASDAQ: SLP4 Investment Highlights For Drug discovery, development, and regulatory approval process Leader in software and services + Share gain opportunity in large and growing market Low market penetration With strong operating leverage Double-digit revenue growth 01 02 03 Accretive M&A Strategy Accretive 04

NASDAQ: SLP5 Our Markets 12-15% Annual Growth (est.) $2B+⁴ Biosimulation TAM (est.) $176B³ Annual Pharma R&D Spend Acceptance & increasing adoption of MIDD technology by industry & regulators. Key Drivers Pharma spend rates continue to grow with large allocation towards Biosimulation Biosimulation growing at 4-5X total R&D spend SLP growing faster than Biosimulation TAM +3%³ Annual Growth (est.)

NASDAQ: SLP6 Drug Development Challenges Avg. cost of $2B and 10+ years to bring a drug to market 1 How is it administered? What are the risks? What is the desired effect? How candidates? How does the drug move through the body? How is it supposed to work? Buying Moves Information Data New Technologies Distribution Market ADMET DMPK Research Analysis Research Analysis Clini al Efficacy Safety Treatment Regimen Pharmacology Lead Selec i Successful Outcomes

NASDAQ: SLP7 Our Value Proposition trial & error with in silico decision making We create value for our customers by accelerating & reducing the cost of R&D through innovative, science-based software & consulting solutions that optimize treatment options and improve patient lives. Streamlines processes & replaces continuously improved with ever-growing data sets Provides accurate models Drug candidate selection with predictive AI & ML capabilities* New efficacy and minimizes toxicity by efficiently identifying dosing regimens Optimizes Better informs clinical trial design and results analysis Informs potential safety liabilities earlier to avoid costly clinical failures Identifies AI = Artificial Intelligence; ML = Machine Learning

Our Value Proposition We create value for our customers by accelerating & reducing the cost of R&D through innovative, science-based software & consulting solutions that optimize treatment options and improve patient lives. OutcomesPatient Efficacy Patient Safety Commercial Success Regulatory Approval AI = Artificial Intelligence; ML = Machine Learning

How We Help Software and Services Software Services Most comprehensive & widely recognized tools for MIDD Ongoing development & reinvestment incorporates latest science & ensures seamless Operational efficiencies that lead to accurate/timely decision making & regulatory reporting Therapeutic, modeling, & regulatory knowledge not always present in-house Resource flexibility for clients with insufficient internal resources or capabilities

Solutions Span Drug Development Process Guiding the path between M&S and pharma R&D

PBPK Software Solutions and AI Data Mining Services PBPK/PBBM Preclinical Regulatory Consulting

QSP/QST Solutions Services QSP Consulting QST Consulting

Pharmacometrics Solutions Services Pharmacometrics Clinical Pharmacology Clinical Regulatory Consulting

NASDAQ: SLP14 Growth Opportunities & Capital Allocation Product Gaps, Adjacencies & Extensions Consolidate Fragmented Market Take Share Low Penetration Rates Market Growth + Regional Expansion Substantial Runway for Growth ▪ Increasing acceptance by industry & FDA ▪ Sales and Distribution Investment o Improve/expand sales infrastructure o New customer growth in U.S., Europe, Asia o Expand small/mid-sized biotech client base o Product and service cross-selling ▪ Fill gaps in the current product offerings, expand TAM o R&D - enhance models & develop new tools o M&A - consolidate market, expand into adjacent markets, market extensions

Environmental, Social, and Governance (ESG) Strategic priorities that form the foundation of our sustainability framework and highlights Environment Social Human Capital Business Governance Committed to renewable energy with our Lancaster Choice Energy Smart Choice 100% renewable energy program Reduced exposure to humans and animals by advancing in silico simulation analyses for chemical safety assessment programs Expand our HR team and capabilities in 2020 with special focus on training and development Advanced growing acceptance of technology by developing collaborations with universities, research organizations, distributors, and government agencies (FDA & NIH) Optimized our data centers by reducing the number of physical servers in our Buffalo, NY, data center from 140 units to just 60 units Supported academic research by partnering with universities and donating free software licenses to support academic research and training Focused on diversity and inclusion with over 39% of our employees from minority backgrounds Created a new corporate data protection officer to standardize and advance our company-wide Data Protection & Customer Privacy framework Implemented business recycling efforts to reduce our environmental footprint and pursue responsible business practices Funded awards and post doctoral research to support education 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 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

Financials

Q1 FY23 Highlights * See reconciliation at end of presentation -4% Revenue Decline -60% Diluted EPS Decline +3% Services Backlog Growth 25% Adj. EBITDA Margin*90% Software Fees Renewal Rate New software releasesContinued strong double-digit software performance Service services backlog growth Strong momentum to begin year Demonstrated scientific leadership Results in-line with guidance Key pharma and regulatory collaborations

NASDAQ: SLP18 Q1 Revenue (in millions) 51% Software 49% Services 59% Software 41% Services 1Q23 MIX 1Q22 MIX $6.2 $7.4 $6.1 $4.5 $5.1 $5.8 1Q21 1Q22 1Q23 Software Services $10.7 $12.4 $12.0 -17% Software Revenue Decline +17% Services Revenue Growth -4% Total Revenue Decline

NASDAQ: SLP19 50% 26% 18% 6% GastroPlus® Monolix Suite™ ADMET Predictor® Other 8% 25% 18% 49% Other PBPK QSP/QST PKPD Software Mix Services Mix Q1 FY23 Revenue Breakdown

NASDAQ: SLP20 Q1 FY23 $12 $15 $16 1Q21 1Q22 1Q23 Backlog (in millions) Backlog Services Performance Metrics Total Projects 57 67 70 12 22 2438 55 73 14 25 26 121 169 193 1Q21 1Q22 1Q23 PKPD QSP/QST PBPK Other

NASDAQ: SLP21 Summary Leader in software and services for the drug discovery, development, and regulatory approval process Low market penetration + share gain opportunity in large and growing market Accretive M&A StrategyDouble-digit revenue growth with strong operating leverage

Thank You Brian Siegel Managing Director Hayden IR +1-346-396-8696 brian@haydenir.com Renee Bouche Simulations Plus +1-661-723-7723 renee@simulations-plus.com Learn More! www.simulations-plus.com Investor Relations Contacts:

NASDAQ: SLP23 References 1. Biopharmaceutical Research and Development: The Process Behind New Medicines. www.PhRMA.org, January 2012, Washington, US http://phrma docs.phrma.org/sites/default/files/pdf/rd_broc hure_022307.pdf. 2. Brochure: “Biopharmaceutical Research & Development: The Process Behind New Medicines”. PhRMA. 3. EvaluatePharma® World Preview 2017, Outlook to 2022, 10th Edition, June 2017, p. 19. 4. Biosimulation Market Size, Share & Trends Analysis Report By Product (Software, Services), By Application (Drug Development, Drug Discovery), By End Use, By Region, And Segment Forecasts, 2021 - 2028

NASDAQ: SLP24 Adjusted EBITDA Reconciliation FY 2022 FY 2023 2022 (in millions) Q1 Q2 Q3 Q4 Q1 FY Net Income $ 3.0 $ 4.4 $ 4.1 $ 1.0 $ 1.2 $ 12.5 Excluding: Interest income and expense, net (0.1) (0.1) (0.1) (0.4) (0.8) (0.7) Provision for income taxes 0.8 1.1 0.7 (0.1) 0.4 2.6 Depreciation and amortization 0.8 1.0 0.9 0.9 0.9 3.6 Stock-based compensation 0.6 0.7 0.7 0.7 0.9 2.7 Mergers & Acquisitions expense — — — 0.3 0.3 0.3 Adjusted EBITDA $ 5.3 $ 7.2 $ 6.3 $ 2.3 $ 3.0 $ 21.0