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

November 16, 2020

(Date of the earliest event reported)

Simulations Plus, Inc.

(Exact name of registrant as specified in its charter)

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 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:

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. □

On November 16, 2020, Simulations Plus, Inc., a California corporation (the "Company"), issued a press release announcing financial results for its fourth quarter and fiscal year ended August 31, 2020. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

On November 16, 2020, the Company held an investor conference call reporting its financial results for its fourth quarter and fiscal year ended August 31, 2020. The PowerPoint presentation, which was used for this investor conference call, is attached herein as exhibit 99.2 to this Report.

In accordance with General Instructions B.2 of Form 8-K, the information in this Report, including Exhibits 99.1 and 99.2, 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 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 Simulations Plus, Inc., a California corporation (the "Company" or "us," "our" or "we") 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.

(d)       Exhibits

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.

Exhibit 99.1

For Further Information:

Simulations Plus, Inc.

42505 10^th Street West

Lancaster, CA 93534-7059

CONTACT:

For Immediate Release:

November 16, 2020

Simulations Plus Reports FY2020 and Fourth Quarter FY2020 Financial Results

Full-Year Revenue Increased 22.4% to $41.6 Million;

Fourth Quarter Revenue Increased 18.9% to $9.5 Million;

Fourth Quarter Diluted EPS of $0.11 and Full-Year Diluted EPS of $0.50

LANCASTER, CA, November 16, 2020– Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today reported financial results for its 2020 fiscal year (FY20) and fourth quarter (4QFY20) ended August 31, 2020.

Full Year FY20 highlights compared with Full Year FY19:

4QFY20 highlights compared with 4QFY19:

Shawn O’Connor, chief executive officer of Simulations Plus, said: “Simulations Plus achieved its goal of accelerating organic growth to 15-20%, overcoming headwinds from the COVID-19 pandemic due to continued strong growth from both our software and consulting revenue streams. Our future growth prospects were bolstered by a significant acquisition to expand our software business, growing our European presence, and the recent introductions of new software versions as well as the launch of several important collaborations. We continue to invest in R&D, funded both internally and from leading pharmaceutical and regulatory agencies, building on our leadership position in modelling and simulation for the drug development marketplace.”

John Kneisel, chief financial officer of Simulations Plus, added: “During the fourth quarter, we completed a strategic offering, issuing approximately 2.1 million shares and raising net proceeds of approximately $107.7 million. This follow-on offering gives the Company resources and scale to pursue additional acquisitions to further bolster our growth rates and broaden the value we can deliver to our clients. Once again, in the fourth quarter we benefited from tax deductions from stock compensation expense as employees took advantage of the increased value of their options. Overall, we continue to generate solid profitability and free cash flow, even after paying our regular quarterly dividend.”

Investor Conference Call

The Company invites all interested persons to attend its conference call at 4:15 p.m. Eastern Time on November 16, 2020. The live webcast/teleconference will be accessible by registering here. Please dial in five to 10 minutes prior to the scheduled start time. A live, listen-only webcast will also be available by dialing (213) 929-4232. A replay of the webcast will be available at the Investors section of the Simulations Plus website following the call.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

For the three months and years ended August 31,

SIMULATIONS PLUS, INC.

CONSOLIDATED BALANCE SHEETS

Exhibit 99.2

Q4 and Fiscal Year 2020 Investor Conference Call Shawn O’Connor, CEO John Kneisel, CFO November 16, 2020 (NASDAQ:SLP)

2 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

FY2020 Highlights : Achieved step up in revenue growth to target of 15 - 20% growth despite COVID - 19 disruption; Completed Lixoft acquisition in Q3; Completed capital raise in Q4; Improved portfolio of software offerings through internal development, collaborations with clients and regulatory agencies, and acquisition; Broadened service offerings and expanded capacity of consulting team; Continued to further science and support clients in their growing use of modeling and simulation to improve their drug development process 3

Strong Revenue Performance (in millions) 4 $29.7 $34.0 $41.6 FY2018 FY2019 FY2020 3 YR CAGR 19% UP 22% FY2020

$17.0 $12.7 $29.7 $18.5 $15.5 $34.0 $21.6 $20.0 $41.6 Software Consulting Total FY2018 FY2019 FY2020 30% Growth 22% Growth Revenue by Source (in millions) 5 16% Growth

FY20Q4 Revenue (in millions) Overall - 19% growth (7% organic) Software – 24% growth (Flat organic) • Renewal rate impacted by several site consolidations • YOY growth rate comparison impacted by FY19 renewals pushed from Q3 to Q4 – FY19 sequential Q3:Q4 growth: 4%:17% – FY20 sequential Q3:Q4 growth: 17%:Flat • Continued COVID - 19 impact on new licenses Consulting – 14% growth • YOY growth rate comparison impacted by accelerated growth in DILIsym revenues beginning in FY19Q4 which peaked with 89% growth in FY20Q1 6 $3.2 $3.5 $6.7 $3.8 $4.2 $8.0 $4.7 $4.8 $9.5 Software Consulting Total 4Q18 4Q19 4Q20

48% 52% Consulting Software Revenue Breakdown Software FY2020 Total Revenue * Includes five months of revenue recorded post acquisition 7 34% 10% 4% 2% 2% GastroPlus ADMET Predictor Monolix Suite* Other Software DILIsym Software Products as % of Total Revenues

Software Product Highlights • GastroPlus; PBPK modeling platform; Collaborations; GastroPlus 9.8 released in October; ADMET Predictor; – ML modeling platform – APX Œ released in September – AI - Driven Drug Design (AIDD) Module; Monolix Suite; Pop PK/PD modeling platform; Monolix Suite 2020R1 released in November; Re - engineered simulations module 8

Software Renewal Rates Q4 Trend FY Trend 9 92% 93% 93% 87% 85% 89% FY2018 FY2019 FY2020 Fees Accounts 91% 93% 88% 86% 86% 93% 4Q18 4Q19 4Q20 Fees Accounts

New Software Customers Q4 Trend 7 20 10 13 13 14 20 33 24 4Q18 4Q19 4Q20 Commercial Non-profit Total FY Trend 37 46 49 39 54 64 76 100 113 FY2018 FY2019 FY2020 Commercial Non-profit Total

11 Commercial Software Companies ($’s in millions) $16.1 $17.6 $20.4 148 159 184 FY2018 FY2019 FY2020 Software License Revenue Revenue Companies 48 53 74 FY2018 FY2019 FY2020 $100K+ Companies

48% 52% Consulting Software FY20 Consulting Business Total Revenue 12 Consulting Offerings as % of Total Revenues 10% 15% 23% PBPK QSP/QST PKPD

Consulting Business Highlights • Recent Client Success – NDA for Pexidartinib – FDA approval of Ubrogepant – OEHHA review of Acetaminophen • New Services – Regulatory Strategies – COVID Strategies • Capacity – 22% increase in FY20 13

Consulting Revenue Sources ($’s in millions) 14 $7.0 $3.4 $2.3 $8.0 $4.3 $3.1 $9.9 $6.1 $4.0 PKPD QSP/QST PBPK Consulting Revenue by Type FY2018 FY2019 FY2020 63 39 69 85 42 77 117 39 97 PKPD QSP/QST PBPK Projects FY2018 FY2019 FY2020

Backlog (in millions) 15 $1.8 $4.9 $1.1 $7.8 $2.9 $6.7 $1.5 $11.1 $3.8 $5.5 $1.2 $10.5 QSP/QST PKPD PBPK Total FY2018 FY2019 FY2020

FY 21 Outlook • Maintain organic growth outlook in 15 - 20% range – Monolix Suite growth delivers an incremental 3 - 5% growth – Additional FY21 acquisitions would be incremental • Software growth FY20: 16% FY21: 20 - 25% – GastroPlus – New 9.8 release with introduction in FY21 of GPX – ADMET Predictor – New release, accelerated growth momentum and AIDD module – Monolix Suite – Performing well and tracking to their 15/30% growth rates as anticipated in the earnout agreement – Price – Price increase and discount policy changes being rolled out – Cross - selling – Prior investments in S&M now being focused on strategic sales initiatives that will provide benefits • Consulting growth FY20: 30% FY21: 25% - 30% – Continued demand across our services with PKPD and PBPK services remaining consistent while DILI settles into a more consistent delivery of project flow • M&A Update – Focused on a population of targets that we believe could add value to our growth strategy and enhance our value to our client base • software entities that extend our modeling and simulation application offering portfolio • service opportunities which provide new service capabilities and/or add to our service capacity or geographic coverage – We continue to adhere to strict acquisition criteria that include product and cultural fit, enhancement of value to our clients, and appropriate valuation accretive characteristics 16

Financial Results

18 Income Statement: 4QFY20 Vs 4QFY19 (in millions) Note: Some numbers may not foot due to rounding. 4QFY20 % of Rev 4QFY19 % of Rev Net sales $ 9.5 100% $ 8.0 100% Revenue Growth 19% 20% Gross profit 6.9 72% 5.7 71% SG&A $ 3.7 39% $ 3.2 40% R&D 0.9 10% 0.6 8% Total operating exp 4.7 49% 3.8 47% Income from operations 2.2 23% 1.9 24% Other income (expense) (0.2) (2)% 0.0 0% Income before income taxes 2.0 21% 2.0 25% Income taxes (Benefit) (0.2) (0%) (0.1) (0%) Effective tax rate (7%) (4%) Net income 2.2 23% 2.1 26% Diluted earnings per share (in dollars) $ 0.11 $ 0.11 EBITDA $ 2.9 30% $ 2.6 32%

19 Income Statement: 12moFY20 Vs 12MoFY19 (in millions) Note: Some numbers may not foot due to rounding. FY20 SG&A includes $1.4M of acquisition related costs. FY20 % of Rev FY19 % of Rev Net sales $ 41.6 100% $ 34.0 100% Revenue Growth 22.4% 14.5% Gross profit 30.9 74% 24.9 73% SG&A $ 16.4 39% 11.8 35% R&D 3.0 7% 2.5 7% Total operating exp 19.3 46% 14.3 42% Income from operations 11.6 28% 10.6 31% Other income (expense) (0.2) (1)% (0.1) (0)% Income before income taxes 11.4 27% 10.6 31% Income taxes 2.1 5% 2.0 6% Effective tax rate 18.0% 18.7% Net income $ 9.3 22% $ 8.6 25% Diluted earnings per share (in dollars) $ 0.50 $ 0.48 EBITDA $ 14.4 35% $ 13.4 39%

20 Revenues : Fiscal Quarter (in millions) $7.1 $7.4 $8.6 $6.7 $7.5 $8.5 $9.9 $8.0 $9.4 $10.3 $12.3 $9.5 Q1 Q2 Q3 Q4 FY2018 FY2019 FY2020

21 EBITDA : Fiscal Quarter (in millions) $3.2 $3.1 $4.1 $2.6 $2.8 $3.4 $4.6 $2.7 $3.4 $3.5 $4.6 $2.9 Q1 Q2 Q3 Q4 FY2018 FY2019 FY2020

Average Revenue per Customer (in 1,000’s) Note: Software revenue per customer excludes academic and non - profit customers 22 $108.7 $110.6 $110.8 $151.8 $161.8 $203.1 FY2018 FY2019 FY2020 Software Consulting

Margins Deliver Steady EPS Growth * Pro forma non - GAAP numbers 23 81% 82% 85% 63% 63% 63% 73% 73% 74% FY2018 FY2019 FY2020 Gross Profit % Software Consulting Total $0.50 $0.48 $0.50 $0.42 $0.48 $0.56 FY2018 FY2019 FY2020 EPS Growth Over Time* EPS (diluted) as reported Proforma EPS

Revenue by Region – FY2020 24 64% 66% 71% 18% 17% 14% 18% 17% 15% FY2018 FY2019 FY2020 Americas Europe Asia

Cash Activity (in millions) 25 $9.4 $11.4 $116.0 FY2018 FY2019 FY2020 Cash and Investments $4.2 $4.2 $4.3 FY2018 FY2019 FY2020 Dividends $9.3 $11.6 $10.9 FY2018 FY2019 FY2020 Cash flow from operations

Headcount 26 FY2018 FY2019 FY2020 Software 29 32 39 Consulting 36 46 56 Sales and Marketing 6 7 8 Other 23 26 34 Total 94 111 137

27 Selected Balance Sheet Items (in millions, except where indicated) August 31, 2020 August 31, 2019 Cash and short - term investments $ 116.0 $ 11.4 Total current assets 129.1 21.2 Total assets 168.4 45.2 Current liabilities 5.5 4.8 Long - term liabilities 6.9 2.7 Total liabilities 12.4 7.5 Shareholders’ equity 156.0 37.7 Total liabilities and shareholders’ equity 168.4 45.2 Current ratio 23.5x 4.4x

Conclusion Tremendous year for SLP!; Focused efforts succeeded in moving the organic growth rate to 15 - 20% target; We added to the SLP family with the acquisition of Lixoft, a significant addition to our software portfolio and an addition of talented scientific staff to our organization; We positioned ourselves for future growth with the completion of our capital raise in August; As a company, we remain focused on delivering good science, measurable value, and quality service to our clients; I'd like to take the opportunity to thank all of our team of outstanding professionals here at SLP for their efforts and devotion to our success during a most unusual but rewarding year 28

Selected Financial Information Nasdaq SLP Cash and short - term investments $116 million Borrowed Debt Outstanding $0.0 Market Capitalization (a/o 11/13/20) $ 1.4B Fully Diluted Shares Outstanding FY2020 18.5M Average Daily Trading Volume (current 30 day - a/o 11/13/20) ~204,000 29

30 Thank you! https://www.linkedin.com/company/simulations - plus https://www.linkedin.com/company/cognigen https://www.linkedin.com/company/dilisym https://www.linkedin.com/company/lixoft/