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

October 25, 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 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:

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 2.02 Results of Operations and Financial Condition

On October 25, 2021, 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, 2021. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

Item 7.01 Regulation FD Disclosure

On October 25, 2021, the Company held an investor conference call reporting its financial results for its fourth quarter and fiscal year ended August 31, 2021. The PowerPoint presentation, which was used for this investor conference call, is furnished 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 and Exhibits 99.1 and 99.2 attached hereto, may contain 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 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 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	Press release issued on October 25, 2021.
99.2	PowerPoint presentation used at the Investor Conference Call on October 25, 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.

Dated: October 25, 2021	SIMULATIONS PLUS, INC.
	By: /s/ Will Frederick
	Will Frederick
	Chief Financial Officer

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EX-99.2

Exhibit 99.1

For Further Information:

Simulations Plus, Inc.

42505 10^th Street West

Lancaster, CA 93534-7059

CONTACT:	Hayden IR
Simulations Plus Investor Relations	Mr. Brian Siegel
Ms. Renee Bouche	346-396-8696
661-723-7723	brian@haydenir.com
renee.bouche@simulations-plus.com

For Immediate Release:

October 25, 2021

Simulations Plus Reports Fourth Quarter and Full Year Fiscal 2021 Results

Fiscal 2021 revenue increased 12% year-over-year to $46.5 million

Software revenue increased 28% year-over-year to $27.7 million

Fiscal 2022 financial outlook for total revenue of $51 million to $53 million, reflecting 10% to 15% year-over-year growth

LANCASTER, CA, October 25, 2021 – Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical and biotechnology industries, today reported financial results for its fourth quarter and full year 2021 fiscal year, ended August 31, 2021.

“We finished the year in a better position than we anticipated following our third quarter earnings report driven by both strong GastroPlus^® sales and continued momentum in ADMET Predictor^® sales following the introduction of new product functionality,” said Shawn O’Connor, chief executive officer. “We also benefitted from our consulting services business returning to more normalized operations with an increasing backlog and improved pipeline of new opportunities, furthering our belief that the events of the third quarter were a short-term occurrence, and the business remains fundamentally healthy.”

Fourth Quarter Financial Highlights (compared with the corresponding period last fiscal year):

· Total revenue increased 3% to $9.8 million

· Software revenue increased 14% to $5.4 million, representing 55% of total revenue

· Services revenue declined 7% to $4.4 million, representing 45% of total revenue

· Gross profit increased 3% to $7.1 million

· Gross margin was unchanged at 72%

· Net income was $0.3 million compared to $2.2 million for the period last fiscal year

· Diluted earnings per share was $0.01 compared to $0.11 for the period last fiscal year

1

Full Year Financial Highlights (compared with the corresponding period last fiscal year):

· Total revenue increased 12% to $46.5 million

· Software revenue increased 28% to $27.7 million, representing 60% of total revenue

· Services revenue declined 6% to $18.8 million, representing 40% of total revenue

· Gross profit increased 16% to $35.9 million

· Gross margin increased from 74% to 77%

· Net income was $9.8 million compared to $9.3 million for the period last fiscal year

· Diluted earnings per share was $0.47 compared to $0.50 for the period last fiscal year

Fiscal 2022 Financial Outlook

The Company expects full year fiscal 2022 total revenue to be in the range of $51 million to $53 million, representing 10% to 15% year-over-year growth.

Software revenue is expected to be in the range of 55% to 60% of total revenue and services revenue is expected to be in the range of 40% to 45% of total revenue. Services revenue is expected to recover sequentially throughout fiscal 2022 and any acquisitions would be incremental to the revenue growth target above.

Mr. O’Connor concluded, “We believe our proven business model and increasing software revenue mix will enable us to grow our bottom line faster than our top line, while generating strong cash flows to further strengthen our balance sheet. Our already strong balance sheet reduces the need to secure additional capital as we’re evaluating strategic acquisition opportunities that we believe can further position us for success and support our revenue CAGR target above 20% as we’ve achieved since our Cognigen acquisition in fiscal 2015.”

Quarterly Dividend Declared

On October 13, 2021, the Company’s Board of Directors declared a cash dividend of $0.06 per share of the Company’s common stock, payable on November 1, 2021, to shareholders of record as of October 25, 2021. The declaration of any future dividends will be determined by the Board of Directors each quarter and will depend on earnings, financial condition, capital requirements, and other factors.

Investor Conference Call

The Company will host a conference call on October 25, 2021, at 5 p.m. Eastern Time. All interested parties are invited to join the call by registering here or by calling 1-201-389-0879. Please join five to 10 minutes before the scheduled start time. The call will be simulcast live on the Internet, and the webcast will be available on the Investors page of the Simulations Plus website under Conference Calls & Presentations. A replay of the webcast will be available on the website approximately one hour following the call.

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, Simulations Plus, Inc. is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. 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. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

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.

--Tables follow--

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SIMULATIONS PLUS, INC.

CONSOLIDATED BALANCE SHEETS

	August 31,
(In thousands, except share and per share amounts)	2021			2020
ASSETS
Current assets
Cash and cash equivalents	$	36,984		$	49,207
Accounts receivable, net of allowance for doubtful accounts of $78 and $50		9,851			7,422
Revenues in excess of billings		3,150			3,093
Prepaid income taxes		1,012			970
Prepaid expenses and other current assets		1,696			1,596
Short-term investments		86,620			66,804
Total current assets		139,313			129,092
Long-term assets
Capitalized computer software development costs,
net of accumulated amortization of  $14,438 and $13,582		7,646			6,087
Property and equipment, net		1,838			438
Operating lease right of use asset		1,276			927
Intellectual property, net of accumulated amortization of $6,516 and $5,087		10,469			11,898
Other intangible assets, net of accumulated amortization of $2,186 and $1,642		6,464			7,008
Goodwill		12,921			12,921
Other assets		51			51
Total assets	$	179,978		$	168,422
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable	$	387		$	351
Accrued payroll and other expenses		5,604			2,251
Contracts payable - current portion		4,550			2,000
Billings in excess of revenues		117			141
Operating lease liability, current portion		382			463
Deferred revenue		534			300
Total current liabilities		11,574			5,506
Long-term liabilities
Deferred income taxes, net		1,726			2,354
Operating lease liability		896			463
Contracts payable - net of current portion		–			4,064
Total liabilities		14,196			12,387
Commitments and contingencies		–			–
Shareholders' equity
Preferred stock, $0.001 par value 10,000,000 shares authorized no shares issued and outstanding	$	–		$	–
Common stock, $0.001 par value and additional paid-in capital — 50,000,000 shares
authorized, 20,141,521 and 19,923,277 shares issued and outstanding		133,418			128,541
Retained earnings		32,407			27,436
Accumulated other comprehensive income (loss)		(43	)		58
Total shareholders' equity		165,782			156,035
Total liabilities and shareholders' equity	$	179,978		$	168,422

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SIMULATIONS PLUS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

	Three months ended August 31,						Years ended August 31,
(in thousands, except per common share amounts)	2021			2020			2021			2020
	(Unaudited)			(Unaudited)
Revenues	$	9,841		$	9,540		$	46,466		$	41,589
Cost of revenues		2,785		$	2,675			10,600			10,649
Gross profit		7,056		$	6,865			35,866			30,940
Operating expenses
Research and development		1,277			948			4,047			2,975
Selling, general and administrative		5,606			3,713			20,566			16,360
Total operating expenses		6,883			4,661			24,613			19,335
Income from operations		173			2,204			11,253			11,605
Other income (expense)
Interest income		46			2			201			30
Interest expense		–			–			(22	)		–
Change in value of contingent consideration		(122	)		(122	)		(486	)		(203	)
Gain (loss) on currency exchange		78			(46	)		139			(45	)
Total other income (expense), net		2			(166	)		(168	)		(218	)
Income before income taxes		175			2,038			11,085			11,387
Provision for income taxes		130			150			(1,303	)		(2,055	)
Net Income	$	305		$	2,188		$	9,782		$	9,332
Earnings per share
Basic	$	0.02		$	0.12		$	0.49		$	0.52
Diluted	$	0.01		$	0.11		$	0.47		$	0.50
Weighted-average common shares outstanding
Basic		20,137			18,289			20,045			17,819
Diluted		20,753			19,152			20,743			18,538
Other comprehensive income (loss), net of tax
Foreign currency translation adjustments		(137	)		28			(101	)		58
Comprehensive income	$	168		$	2,216		$	9,681		$	9,390

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EX-99.1

Exhibit 99.2

1 | NASDAQ: SLP Earnings Call – Q4 FY21 October 25, 2021 1

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 . 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 . Safe Harbor Statement

3 | NASDAQ: SLP Financial Highlights » Total Revenue Growth Exceeds Revised Guidance • 12% growth for FY21 vs. guidance of 5 - 10% growth » Continued Strong Software Performance • 28% revenue growth for FY21 vs. guidance of 20 - 25% growth • Accelerated growth continues » Service Business Continues to Build Backlog • 6% revenue decline for FY21 vs. guidance of 7 - 12% decline • Q4 performance as expected with good underlying pipeline

4 | NASDAQ: SLP GastroPlus® » 20% growth in quarter; 16% for FY21 » 17 peer reviewed journal articles published in Q4 » 20 multi - year licenses during FY21 +20% Monolix® YOY Growth 20 Multi - year Licenses Signed +20% ADMET Predictor® YOY Growth 3 New $100k+ customers 14 Upsells MonolixSuite® » Q4 declined as expected; YOY decline due to early renewals during year » 20% FY21 revenue growth (full year vs full year) » New Monolix Suite release schedule for Q1 FY22 ADMET Predictor® » 26% growth in quarter; 20% for FY21 » New functionality delivered in Q3 continues to support accelerated growth Software Highlights

5 | NASDAQ: SLP Services Highlights PKPD » Q4 project disruptions returning to “normal” levels » Underlying bookings activity is good ▪ 10% increase in backlog for Q4; 49% increase for FY21 » Significant client support in Q4 ▪ Critical support to multi region regulatory approval and FDA submission of new COVID therapy » Operational improvements achieved ▪ Increases in average contract value, yield and consultant utilization rates for FY21 QSP/QST » 1 new + 1 renewal DILIsym consortium members in Q4 » Q4 revenue down as anticipated but pipeline activity has accelerated ▪ Q1 FY22 bookings target achieved midway through quarter ▪ Toxicological project opportunities picked up and multiple QSP projects in late - stage proposal status PBPK » 2 significant FDA funded projects announced in Q4 » 63% increase in backlog for FY21 +23% Backlog YOY Growth 5 New PKPD Clients 36% Projects YOY Growth

6 | NASDAQ: SLP FY22 Outlook Growth Targets: 10% to 15% Total Revenue Growth 55% to 60% Software Revenue % of Total Revenue 40% to 45% Service Revenue % of Total Revenue Commentary: » Software business carries strong momentum; incremental releases planned for FY22. » Services business remains volatile but long - term outlook remains unchanged; backlog rebuilt and pipeline activity is strong » Focus on business development through strategic investment in sales and marketing & cross selling efforts » M&A remains strategic enhancement to organic growth objectives

7 | NASDAQ: SLP Financial Results

8 | NASDAQ: SLP Q4 Revenue (in millions) +3% Total Revenue $3.8 $4.7 $5.4 $4.2 $4.8 $4.4 $8.0 $9.5 $9.8 4Q19 4Q20 4Q21 Software Services 50% 50% 4Q20 Mix Software Services 55% 45% 4Q21 Mix Software Services +14% Software Revenue - 7% Services Revenue Q4 Revenue (in millions)

9 | NASDAQ: SLP YTD Revenue (in millions) $18.5 $21.6 $27.7 $15.5 $20.0 $18.8 $34.0 $41.6 $46.5 FY19 FY20 FY21 Software Services +12% Total Revenue +28% Software Revenue - 6% Services Revenue 52% 48% FY20 Mix Software Services 60% 40% FY21 Mix Software Services Fiscal Year Revenue (in millions)

10 | NASDAQ: SLP 81% 83% 85% 63% 61% 55% 71% 72% 72% 4Q19 4Q20 4Q21 Software Services Total Gross Margin Trends – Q4

11 | NASDAQ: SLP Gross Margin Trends – Fiscal Year 84% 87% 88% 61% 61% 61% 73% 74% 77% FY19 FY20 FY21 Software Services Total

12 | NASDAQ: SLP Software Revenue by Product 57% 22% 15% 6% Q4 FY21 Software Product as % of Software Revenue 59% 18% 16% 7% FY21 Other Other

13 | NASDAQ: SLP Software Performance Metrics – Q4 Avg. Revenue per Customer (in thousands) $42 $42 $55 $60 $62 $65 FY19 FY20 FY21 All Companies Commercial Companies 93% 88% 90% 86% 93% 77% FY19 FY20 FY21 Fees Accounts Software Performance Metrics – Q4 50%+ of FY21 non - renewals are nonprofit accounts Renewal Rates

14 | NASDAQ: SLP Software Performance Metrics – YTD Avg. Revenue per Customer (in thousands) $67 $69 $85 $111 $111 $121 FY19 FY20 FY21 All Companies Commercial Companies Renewal Rates 93% 93% 92% 85% 89% 83% FY19 FY20 FY21 Fees Accounts Software Performance Metrics – Fiscal Year 50%+ of FY21 non - renewals are nonprofit accounts

15 | NASDAQ: SLP Services Revenue by Type 6% 16% 25% 53% Other PBPK QSP/QST PKPD Q4 FY21 Services Types as % of Service Revenue 9% 14% 28% 49% Other PBPK QSP/QST PKPD YTD FY21

16 | NASDAQ: SLP Services Performance Metrics $11.1 $10.5 $13.0 FY2019 FY2020 FY2021 Backlog (in millions) 85 117 176 42 39 24 77 97 81 62 204 253 343 FY2019 FY2020 FY2021 PKPD QSP/QST PBPK Other Backlog Services Performance Metrics Total Projects

17 | NASDAQ: SLP Income Statement Summary – Q4 (in millions, except EPS) FY21 % of Rev FY20 % of Rev Revenues $9.8 100% $9.5 100% Revenue Growth 3% 19% Gross profit 7.1 72% 6.9 72% R&D 1.3 13% 0.9 9% SG&A 5.6 57% 3.7 39% Total operating exp 6.9 70% 4.7 49% Income from operations 0.2 2% 2.2 23% Other income (expense) 0.0 0% (0.2) - 2% Income before income taxes 0.2 2% 2.0 21% Income taxes (0.1) - 1% (0.2) - 2% Effective tax rate - 73% - 7% Net income $0.3 3% $2.2 23% Diluted earnings per share $0.01 $0.11 EBITDA $1.1 11% $2.9 31%

18 | NASDAQ: SLP Income Statement Summary – Fiscal Year (in millions, except EPS) FY21 % of Rev FY20 % of Rev Revenues $46.5 100% $41.6 100% Revenue Growth 12% 22% Gross profit 35.9 77% 30.9 74% R&D 4.0 9% 3.0 7% SG&A 20.6 44% 16.4 39% Total operating exp 24.6 53% 19.3 46% Income from operations 11.3 24% 11.6 28% Other income (expense) (0.2) 0% (0.2) - 1% Income before income taxes 11.1 24% 11.4 27% Income taxes 1.3 3% 2.1 5% Effective tax rate 12% 18% Net income $ 9.8 21% $9.3 22% Diluted earnings per share $0.47 $0.50 EBITDA $14.5 31% $14.3 34%

19 | NASDAQ: SLP Balance Sheet Summary (in millions) Aug. 31, 2021 Aug. 31, 2020 Cash and short - term investments $123.6 $116.0 Total current assets 139.3 129.1 Total assets 180.0 168.4 Current liabilities 11.6 5.5 Long - term liabilities 2.6 6.9 Total liabilities 14.2 12.4 Shareholders’ equity 165.8 156.0 Total liabilities and shareholders’ equity 180.0 168.4

20 | NASDAQ: SLP Conclusion » Industry adoption of model informed drug development tools and techniques continues to expand » Scientific credibility with academia and regulatory agencies » Software business with accelerated revenue growth rates and expanded product functionality » Services business steadily normalizing with improved backlog and strong bookings SECURE LEADERSHIP POSITION IN BIOSIMULATION MARKET

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Cover [Abstract]
Document Type	8-K
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Entity File Number	001-32046
Entity Registrant Name	Simulations Plus, Inc.
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Entity Tax Identification Number	95-4595609
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