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

February 18, 2021

Date of Report (Date of 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 10^th 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 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the 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 February 18, 2021, Simulations Plus, Inc., a California corporation (the “Company”), conducted an investor webinar at the BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference using the presentation attached hereto as Exhibit 99.1 to this Current Report on Form 8-K. The presentation has also been posted to the Company’s website in the “Investors” section.

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.

Forward-Looking Statements

This Current Report on Form 8-K and the exhibit(s) attached hereto (collectively, the “Report”), including the disclosures set forth herein, 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 hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), reports to the stockholders of the Company 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 Investor conference presentation, dated February 18, 2021.

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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: February 18, 2021	By:     /s/Will Frederick
	Will Frederick
	Chief Financial Officer

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EX-99.1

Exhibit 99.1

BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference February 18, 2021 (NASDAQ:SLP)

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 : 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 on the Company’s risk factors is contained in the Company’s quarterly and annual reports and filed with the Securities and Exchange Commission . Safe Harbor Statement

□ Industry - leading provider of modeling and simulation solutions used by major pharmaceutical, biotech, chemical, consumer goods companies and regulatory agencies worldwide □ Innovative software and services to improve drug development from discovery to regulatory approval with supportive guidance from the FDA and ability to lower cost and time to market with a higher likelihood of success □ Solutions bridge machine learning and include pharmacokinetic - pharmacodynamic ( PKPD ), quantitative systems pharmacology & toxicology ( QSP/QST ), and physiologically based pharmacokinetic ( PBPK ) modeling □ 10+ year track record of consistent revenue and profitability growth and successful M&A strategy Company Overview 3

• Our solutions allow customers to model and predict results of chemical and biological tests required in the R&D process to improve success rates at multiple points in the process: − Computational AI models help scientists streamline and improve their processes − Machine learning improves the models with ever - growing data sets − Better informed clinical trial design and analyze clinical results − Identify potential safety liabilities earlier, avoiding costly clinical failures − Optimize efficacy and minimize toxicity by efficiently identifying dosing regimens Our Value Proposition Avg. cost of $1.4B and 10+ years to bring a drug to market 1,2 4 We’ve helped bring 40+ drugs to market and informed multiple development programs

We Improve Drug Discovery and Development Discovery Preclinical Development Clinical Studies Regulatory Approval MedChem Designer ADMET Predictor GastroPlus DDDPlus MembranePlus DILIsym Monolix NAFLDsym Consulting Services RENAsym 5

PKPD Software Solutions Population PKPD Model to support dose regimen, risk exposure, clinical trial protocol design and analysis, drug label specifications and regulatory submission KIWI Monolix Suite Cloud - based data management application Datxplore PKanalix Mlxplore Monolix Simulx Exploration and visualization of data Non - compartmental and compartmental analysis Exploration and visualization of complex models Non - linear mixed effects (NME) modeling engine Clinical trial pharmacometrics simulations 6

QSP/QST Software Solutions Determine potential drug - induced liver injury hazard posed by individual drug candidates to support clinical trial optimization Additional QSP models NAFLDsym RENAsym DILIsym Assess the potential for drug - induced kidney injury of drug candidates to support clinical trial optimization and clinical trial decision making NASH model to predict efficacy for treatment modalities to support clinical trial optimization and clinical trial decision making IPFsym (Idiopathic pulmonary fibrosis) RADAsym (Acute radiation exposure) 7

PBPK Software Solutions and AI Data Mining Simulating IV, oral, oral cavity, ocular, inhalation, skin and IM absorption, PBPK, PBBM, PD modeling and drug - drug interactions MembranePlu s MedChem Designer DDDPlus ADMET Predictor GastroPlus QSAR modeling enabling rapid prediction of 140+ ADMET properties Used for lead generation and optimization Mechanistic simulation engine for the in vitro dissolution predictions to accelerate and optimize drug formulation Predict how fast a drug candidate will pass across the important physiological membrane barriers (GI, BBB) Chemical sketching tool with ADMET property predictions in connection with ADMET Predictor 8

• 70+ scientific PhD experts provide insightful solutions to improve the productivity of science - based drug development • Focusing on lead selection, pharmacology, ADMET and DMPK, dose regimen, efficacy and safety • Capabilities include: − Population PKPD data assembly, modeling, simulation, analysis and regulatory submission − PBPK modeling and simulation − Liver and kidney safety modeling and analysis − QSP/QST modeling support and analysis − AI drug candidate prioritization − Global regulatory strategies − Regulatory and scientific writing Services Solutions 9

Janssen Case Study: Accelerating Regulatory Interactions Virtual crossover trials to establish drug product specification after manufacturing changes • Janssen changed the manufacturing process to improve efficiencies with scale - up techniques post approval • FDA requested clinical study to confirm bioequivalence • Built and validated the baseline model in GastroPlus® using existing clinical data from previously approved lots • Assessed impact of formulation changes; defined drug product specifications • Performed virtual trial simulations in different populations to confirm bioequivalence • FDA accepted the GastroPlus® modeling results, clinical study request was waived 10

In Silico Methods Improve the Probability of Phase 3 Success Client Case Study: Strategic Use of Modeling & Simulation • Client with novel antibody for prophylactic use in competitive migraine market had Phase 3 development plan with predicted probability of success of <15% • Iteratively developed model throughout Phase 1 & Phase 2 • I mplemented model - based clinical trial simulation strategy to improve Phase 3 design • Phase 3 trials demonstrated safety and efficacy in preventing migraine • Months of development time and millions of dollars saved by avoiding failed Phase 3 trials, also reduced time to approval and market • Reduced unnecessary burden on patients by evaluating multiple alternatives in silico before running trials 11

Revenue Growth Drivers Increasing acceptance of modeling and simulation by FDA and drug industry High customer satisfaction with ~95% software contract renewal rate (by fees) Recently improved and expanded sales infrastructure Increasing opportunities for product and service cross - selling Synergistic acquisitions Steadily increasing industry R&D spend 19%+ Revenue CAGR 12

$14.9 $17.0 $18.5 $21.6 $9.2 $12.7 $15.5 $20.0 FY17 FY18 FY19 FY20 Software Services Consistent Year - over - Year Revenue Performance 19% CAGR (in millions) 22% Growth 13 $ 24.1 $ 29.7 $ 34.0 $ 41.6

FY20 Software and Services Mix 14 Software Products % of Total Revenues 34% 10% 4% 4% GastroPlus ADMET Predictor Monolix Suite* Other Software 10% 15% 23% PBPK QSP/ QST PKPD Services Offerings % of Total Revenues

• Expand product offerings through opportunistic acquisitions − Fill gaps in the current product offerings − Focus on immediately or near - term accretive opportunities − Fragmented industry amenable to consolidation • Further expand global sales reach − Increase sales effort to drive new customer growth in U.S., Europe and Asia − Expand client base in the small and mid - sized biotechnology space − Focus on cross - selling efforts to increase average revenue per customer • Increase R&D investment to enhance existing models and develop new tools to broaden product offerings Strategic Opportunities for Expansion and Growth 15

• Total Revenue Growth − Q1 performance: 14% y/y growth − Full - year target range: 15 - 20% y/y organic growth plus 3 - 5% from Lixoft • Software Revenue Growth − Q1 performance: 35% y/y growth − Full - year target range: 20 - 25% y/y growth • Services Revenue Growth − Q1 performance: 6% y/y decline − Full - year target range: 25 - 30% y/y growth • Q1 Profitability − Gross margin was 77%, up from 72% − Net income increased 21% y/y to $2.5 million − Diluted earnings per share increased 9% y/y to $0.12 • M&A Efforts − Continuing to explore opportunities and acquisitions would be incremental to revenue growth targets above Q1 FY21 Performance & FY21 Full Year Outlook 16

• Provider of innovative modeling and simulation software and consulting services focused on pharmaceutical and biotechnology companies − Solutions from early discovery through regulatory approval • Pure play in the in silico drug discovery space • Growing acceptance of technology by regulators and industry with supportive guidance issued by the FDA • Products have the potential to reduce drug development costs and time while improving success rates • Steady growth in pharmaceutical industry R&D expenditures provides expanding target market − ~$170B in 2020 growing around 3% per year 3 • Ten - year track record of consistent revenue and profitability growth − Recent revenue CAGR of 20%+ Investment Highlights 17

Financial Summary and Selected Financial Information Nasdaq SLP Q1 Cash and short - term investments $119M Q1 Borrowed Debt Outstanding $0 Market Capitalization (a/o 2/10/21) $1.6B Q1 Fully Diluted Shares Out 20.8M 30 - Day Average Daily Trading Volume (a/o 2/10/21) ~225K 18

Thank you! https://www.simulations - plus.com

1. J Health Econ . 2016 May;47:20 - 33. 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. References