8-K

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

September 14, 2022

(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 September 14, 2022, Simulations Plus, Inc., a California corporation (the “Company”), will present at the Baird 2022 Global Healthcare 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 the Company or its 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 the Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s 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 the Company’s business and the accuracy of the forward-looking statements contained herein. The Company’s 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	Baird 2022 Global Healthcare Conference Presentation, September 14, 2022.
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: September 14, 2022	By: /s/ Will Frederick
	Will Frederick
	Chief Financial Officer

2

EX-99.1

1 | NASDAQ: SLP Investor Presentation NASDAQ: SLP Q3 FY22 Update 1

2 | NASDAQ: SLP 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. 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.

3 | NASDAQ: SLP 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). 1996 Founded >150 Employees >10 yrs Profit/rev growth >1300 Publications >70 Scientific PhDs >90% Client Retention >250 Clients

4 | NASDAQ: SLP Investment Highlights 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 Double-digit revenue growth with strong operating leverage Accretive M&A Strategy

5 | NASDAQ: SLP Our Markets Key Drivers 1. Acceptance & increasing adoption of MIDD technology by industry & regulators 2. Pharma spend rates continue to grow with large allocation towards Biosimulation 3. Biosimulation growing at 4-5X total R&D spend SLP growing faster than Biosimulation TAM $176B³ Annual Pharma R&D Spend $2B+⁴ Biosimulation TAM (est.) 12-15% Annual Growth (est.) +3%³ Annual Growth (est.)

6 | NASDAQ: SLP Drug Development Challenges Avg. cost of $2B and 10+ years to bring a drug to market 1 What candidates? How does the drug move through the body? How is it administered? How is it supposed to work? What is the desired effect? What are the risks? Lead Selection Pharmacology ADMET DMPK Treatment Regimen Clinical Efficacy Safety

7 | NASDAQ: SLP 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. Outcomes Patient Efficacy Patient Safety Regulatory Approval Commercial Success AI = Artificial Intelligence; ML = Machine Learning Streamlines processes & replaces trial & error with in silico decision making Provides accurate models, continuously improved with ever-growing data sets Improves new drug candidate selection with predictive AI & ML capabilities* Better informs clinical trial design and results analysis Identifies potential safety liabilities earlier to avoid costly clinical failures Optimizes efficacy and minimizes toxicity by efficiently identifying dosing regimens

8 | NASDAQ: SLP How We Help – Software and Services Software Most comprehensive & widely recognized tools for MIDD Ongoing development & reinvestment incorporates latest science & ensures seamless UX Services 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

9 | NASDAQ: SLP Consulting Services & Regulatory Interactions QSP/QSTOther Software Pharmacometrics Solutions Span Drug Development Process Guiding the path between M&S and pharma R&D Cheminformatics AI ML PBPK/PBBM

10 | NASDAQ: SLP Safety Clinical Efficacy ADMET DMPK Treatment Regimen Lead Selection Pharmacology Services PBPK/PBBM Preclinical Regulatory Consulting Software PBPK Software Solutions and AI Data Mining

11 | NASDAQ: SLP QSP/QST Solutions Services QSP Consulting QST Consulting Software Safety Clinical Efficacy ADMET DMPK Treatment Regimen Lead Selection Pharmacology

12 | NASDAQ: SLP Pharmacometrics Solutions Services Pharmacometrics Clinical Pharmacology Clinical Regulatory Consulting Software Safety Clinical Efficacy ADMET DMPK Treatment Regimen Lead Selection Pharmacology

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

14 | NASDAQ: SLP Environmental, Social, and Governance (ESG) 14 Strategic priorities that form the foundation of our sustainability framework and highlights

15 | NASDAQ: SLP Financials 15

16 | NASDAQ: SLP Q3 FY22 Highlights ➢Strong momentum to begin year ➢Continued strong double-digit software performance ➢ Service services backlog growth +17% Revenue Growth +11% Diluted EPS Growth +34% Services Backlog Growth ➢Demonstrated scientific leadership ➢New software releases ➢Key pharma and regulatory collaborations ➢Results in-line with guidance 42% Adj. EBITDA Margin* 92% Software Renewal Rates * See reconciliation at end of presentation

17 | NASDAQ: SLP Q4 Revenue (in millions) +17% Total Revenue Growth $6.9 $8.3 $9.6 $5.4 $4.5 $5.3 $12.3 $12.8 $14.9 3Q20 3Q21 3Q22 Software Services 65% 35% 3Q21 Mix Software Services 64% 36% 3Q22 Mix Software Services +16% Software Revenue Growth 19% Services Revenue Growth Q3 FY22 Revenue (in millions)

18 | NASDAQ: SLP 67% 11% 16% 6% Q3 FY22 Revenue Breakdown 5% 25% 23% 47% Other PBPK QSP/QST PKPD Software Mix Services Mix Other

19 | NASDAQ: SLP Services Performance Metrics $12 $12 $17 3Q20 3Q21 3Q22 Backlog (in millions) Backlog Q3 FY22 Services Performance Metrics Total Projects 64 45 76 18 18 21 54 33 83 35 16 136 131 196 3Q20 3Q21 3Q22 PKPD QSP/QST PBPK Other

20 | NASDAQ: SLP 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 Double-digit revenue growth with strong operating leverage Accretive M&A Strategy

21 | NASDAQ: SLP Thank you! Investor Relations Contacts: 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

22 | NASDAQ: SLP 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_brochure_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

23 | NASDAQ: SLP Adjusted EBITDA Reconciliation SIMULATIONS PLUS, INC. (Unaudited) 2021 2022 (in millions) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Fiscal Year Fiscal YTD Net Income 2.5$ 3.2$ 3.8$ 0.3$ 3.0$ 4.4$ 4.1$ 9.8$ 11.5$ Excluding: Interest income and expense, net (0.1) (0.0) (0.0) (0.0) (0.1) (0.1) (0.1) (0.2) (0.3) Provision for income taxes 0.5 0.2 0.7 (0.1) 0.8 1.1 0.7 1.3 2.7 Depreciation and amortization 0.9 0.9 0.9 1.0 0.8 1.0 0.9 3.6 2.7 Stock-based compensation 0.5 0.7 0.6 0.6 0.6 0.7 0.7 2.4 2.0 Adjusted EBITDA 4.3$ 5.0$ 5.9$ 1.7$ 5.3$ 7.2$ 6.3$ 16.9$ 18.7$ Reconciliation of Adjusted EBITDA to Net Income 2021 2022

XML

Cover	Sep. 14, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 14, 2022
Entity Registrant Name	Simulations Plus, Inc.
Entity Central Index Key	0001023459
Entity Incorporation, State or Country Code	CA
Entity File Number	001-32046
Entity Tax Identification Number	95-4595609
Entity Address, Address Line One	42505 10th Street West
Entity Address, City or Town	Lancaster
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	93534-7059
City Area Code	661
Local Phone Number	723-7723
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	SLP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false