UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 7.01 | Regulation 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 9.01 | Financial Statements and Exhibits |
(d) Exhibits
99.1 | Investor 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 |
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