0001683168-21-004387.txt : 20210921 0001683168-21-004387.hdr.sgml : 20210921 20210921151834 ACCESSION NUMBER: 0001683168-21-004387 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 36 CONFORMED PERIOD OF REPORT: 20210920 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210921 DATE AS OF CHANGE: 20210921 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Simulations Plus, Inc. CENTRAL INDEX KEY: 0001023459 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMPUTER INTEGRATED SYSTEMS DESIGN [7373] IRS NUMBER: 954595609 FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32046 FILM NUMBER: 211266222 BUSINESS ADDRESS: STREET 1: 42505 10TH STREET WEST CITY: LANCASTER STATE: CA ZIP: 93534-7059 BUSINESS PHONE: 661-723-7723 MAIL ADDRESS: STREET 1: 42505 10TH STREET WEST CITY: LANCASTER STATE: CA ZIP: 93534-7059 FORMER COMPANY: FORMER CONFORMED NAME: SIMULATIONS PLUS INC DATE OF NAME CHANGE: 19960923 8-K 1 simulations_i8k.htm FORM 8-K
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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 20, 2021

(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 7.01Regulation FD Disclosure

 

On September 20, 2021, Simulations Plus, Inc., a California corporation (the “Company”), presented at the Bank of America Securities 2021 Tech Solutions for Drug Discovery Conference using the presentation attached 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, except as expressly set forth by specific reference 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 (the “Report”), including the disclosures set forth herein and 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 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 forward-looking statements speak only as of the date of this Current Report and are subject to a number of risks, uncertainties and assumptions. The events and circumstances reflected in such forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements due to risks, uncertainties and other factors described in the Company’s press releases and in its filings with the Commission, including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. Moreover, the Company operates in a very competitive and rapidly changing environment. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict all risks and uncertainties. Except as required by applicable law, the Company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Item 9.01Financial Statements and Exhibits

 

(d)       Exhibits

 

99.1Investor conference presentation, dated September 20, 2021.
  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 21, 2021 By: /s/ Will Frederick                    
Will Frederick
  Chief Financial Officer

 

 

EX-99.1 2 simulations_ex9901.htm INVESTOR CONFERENCE PRESENTATION, DATED SEPTEMBER 20, 2021

Exhibit 99.1

 

 

1 | NASDAQ: SLP Investor Presentation NASDAQ: SLP September 2021 1

 
 

Safe Harbor Statement 2 | 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, 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 .

 
 

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 >140 Employees >10 yrs P r ofi t / r e v gr owth >1300 Publications >70 Scie n tific PhDs >90% Client Retention >250 Clients 3 | NASDAQ: SLP

 
 

Investment Highlights 4 | NASDAQ: SLP 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

 
 

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.) 5 | 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 Phar ma c o l ogy A DMET DMPK T r e a t m e n t Regimen Clinical E fficacy S a f e ty 6 | 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 7 | NASDAQ: SLP 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

 
 

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 8 | NASDAQ: SLP

 
 

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

 
 

Safety Clinical E ff i cacy AD M ET DMPK Tr e a tm en t Regimen Lead Selection Pharmacology Services PBPK/PBBM Preclinical Regulatory Consulting Software PBPK Software Solutions and AI Data Mining 10 | NASDAQ: SLP

 
 

QSP/QST Solutions Services QSP Consulting QST Consulting Software S afe ty Clinical Effi c a cy A DMET DMPK Treatment Regimen Lead Selection Pharmacology 11 | NASDAQ: SLP

 
 

Pharmacometrics Solutions Services Pharmacometrics Clinical Pharmacology Clinical Regulatory Consulting Software Sa fe ty Clinical Effi c a c y AD M ET DMPK Treatment Regimen Lead Se l e ct i o n Pharmacology 12 | NASDAQ: SLP

 
 

Product Gaps, Adj a c en c i e s & Extensions Consolidate Fr a g me n ted Market T a ke S h a re Low Pe n e tr a ti o n 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 Ex pa n si o n 13 | NASDAQ: SLP

 
 

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

 
 

Financials 15 | NASDAQ: SLP

 
 

$17.0 $18.5 $21.6 $ 2 2 . 3 $27.1 $12.7 $15.5 $20.0 $14.3 $19.1 F Y18 F Y19 F Y20 F Y21 Y T D TTM Software Services 16 | NASDAQ: SLP Revenue ($ m ) $29.7 $34.0 $36.6 $41.6 $46.2

 
 

69% Americas 19% EM E A 11% A P A C 17 | NASDAQ: SLP Global Customer Base Revenue By Region – YTD FY21

 
 

YTD Revenue Breakdown Through 3Q21 17% 60% PKPD QSP/QST 29% 43% 16% PBPK 14% 7% Other 14% Software Mix Services Mix Ot h er 18 | NASDAQ: SLP

 
 

Services Performance Metrics $11.8 $12.4 3Q20 3Q21 Backlog (in millions) 50 64 45 17 18 18 41 54 33 35 3Q19 136 108 131 Projects During Qtr. Backlog Q S P / Q S T 3Q20 PBPK PK P D 3Q21 Other 19 | NASDAQ: SLP

 
 

Sum m ary 20 | NASDAQ: SLP 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

 
 

References 21 | NASDAQ: SLP 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

 
 

Thank you! Investor Relations Contacts: Brian Siegel Managing Director Hayden IR +1 - 346 - 396 - 8696 brian@haydenir.com Renee Bouche Simu l a ti on s P l us +1 - 661 - 723 - 7723 renee@simulations - plus.com Learn More! www.simulations - plus.com 22 | NASDAQ: SLP

 

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