8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

April 12, 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 April 12, 2021, Simulations Plus, Inc., a California corporation (the "Company"), issued a press release announcing financial results for its second quarter of fiscal year 2021 ended February 28, 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 April 12, 2021, as part of the press release above, the Company announced that its board of directors has declared a quarterly cash dividend of $0.06 per share of common stock, payable on May 3, 2021 to shareholders of record on April 26, 2021.

In addition, on April 12, 2021, the Company held an investor conference call reporting its financial results for its second quarter of fiscal year 2021 ended February 28, 2021. The PowerPoint presentation, which was used for this investor conference call, is attached 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, 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 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 April 12, 2021.
99.2	PowerPoint presentation used at the Investor Conference Call on April 12, 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: April 12, 2021	By: /s/ Will Frederick
	Will Frederick
	Chief Financial Officer

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EX-99.1

Exhibit 99.1

 

For Further Information:

Simulations Plus, Inc.

42505 10^th Street West

Lancaster, CA 93534-7059

CONTACT:
Simulations Plus Investor Relations	Hayden IR
Ms. Renee Bouche	Mr. Cameron Donahue
661-723-7723	651-653-1854
renee@simulations-plus.com	slp@haydenir.com

For Immediate Release:

April 12, 2021

Simulations Plus Reports Record Second Quarter Fiscal 2021 Financial Results

Second quarter revenue of $13.1 million, reflecting 27% year-over-year growth

Board of Directors announces quarterly dividend of $0.06 per share

LANCASTER, CA, April 12, 2021 – Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today reported financial results for its second quarter of fiscal 2021, ending February 28, 2021.

Q2 Financial highlights compared with the corresponding period last fiscal year:

· Revenue increased 27% to $13.1 million

· Gross profit increased 33% to $10.2 million

· Gross margin was 78%, up from 74%

· Net income increased 49% to $3.2 million

· Diluted earnings per share increased 25% to $0.15 per share

YTD Financial highlights compared with the corresponding period last fiscal year:

· Revenue increased 21% to $23.8 million

· Gross profit increased 28% to $18.5 million

· Gross margin was 78%, up from 73%

· Net income increased 35% to $5.7 million

· Diluted earnings per share increased 17% to $0.27 per share

Shawn O’Connor, chief executive officer of Simulations Plus, said: “We delivered excellent 27% overall revenue growth, outpacing our annual targets. During the quarter, we also successfully completed our first sponsored conference, the MIDD+ Scientific Conference, a two-day event focused on delivering customized modeling and simulation content specifically for pharmaceutical scientists and their organizations, which was widely attended. We also won several funded collaboration projects and released new versions of GastroPlus® and Monolix Suite™. In summary, this was a productive quarter for Simulations Plus and an encouraging first six months of the fiscal year.”

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“While we expect growth to normalize in the second-half of our fiscal year, and are maintaining our full-year growth targets of 15-20%, this first-half performance underscores the strength and diversification of our business model”, continued Mr. O’Connor. “We have built a global organization selling an expanding portfolio of software and services to pharma and regulatory customers, and our growth is increasingly facilitating cross-selling as we leverage our industry leadership. This growth is largely dropping to our bottom line, increasing profitability and bolstering our ability to make additional strategic acquisitions.”

Quarterly Dividend Declared

The Company’s Board of Directors has declared a cash dividend of $0.06 per share of the Company’s common stock payable on May 3, 2021, to shareholders of record as of April 26, 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 has announced an investor conference call that will be webcast live at 1:15 p.m. PDT/4:15 p.m. EDT on Monday, April 12, 2021. The live webcast/teleconference will be accessible by registering here or by calling 1-201-389-0879. Please join five to ten 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.

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. 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.

CONDENSED CONSOLIDATED BALANCE SHEETS

	(Unaudited)		(Audited)
(in thousands, except share and per share amounts)	February 28,		August 31,
ASSETS
	2021		2020
Current assets
Cash and cash equivalents	$	42,385	$	49,207
Accounts receivable, net of allowance for doubtful accounts of $100 and $50		11,306		7,422
Revenues in excess of billings		3,837		3,093
Prepaid income taxes		1,250		970
Prepaid expenses and other current assets		1,408		1,596
Short-term investments		75,367		66,804
Total current assets		135,553		129,092
Long-term assets
Capitalized computer software development costs,net of accumulated amortization of $14,271 and $13,582		6,871		6,087
Property and equipment, net		924		438
Operating lease right of use assets		1,532		927
Intellectual property, net of accumulated amortization of  $5,801 and $5,087		11,184		11,898
Other intangible assets, net of accumulated amortization of $1,917 and $1,642		6,733		7,008
Goodwill		12,921		12,921
Other assets		51		51
Total assets	$	175,769	$	168,422
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable	$	400	$	351
Accrued payroll and other expenses		2,891		2,251
Current portion -  contracts payable		2,000		2,000
Billings in excess of revenues		258		141
Operating lease liability, current portion		469		463
Deferred revenue		523		300
Total current liabilities		6,541		5,506
Long-term liabilities
Deferred income taxes, net		2,360		2,354
Operating lease liability		1,064		463
Payments due under contracts payable		4,307		4,064
Total liabilities		14,272		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, 20,059,528 and 19,923,277 shares issued and outstanding		130,713		128,541
Retained earnings		30,730		27,436
Accumulated other comprehensive income		54		58
Total shareholders' equity		161,497		156,035
Total liabilities and shareholders' equity	$	175,769	$	168,422

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SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

For the three and six months ended February 28, 2021 and February 29, 2020

	Three months ended						Six months ended
	(Unaudited)						(Unaudited)
(in thousands, except per common share amounts)	2021			2020			2021			2020
Revenues	$	13,147		$	10,350		$	23,848		$	19,751
Cost of revenues		2,911			2,666			5,344			5,309
Gross margin		10,236			7,684			18,504			14,442
Operating expenses
Selling, general, and administrative		5,458			4,110			9,866			7,623
Research and development		1,292			748			2,101			1,274
Total operating expenses		6,750			4,858			11,967			8,897
Income from operations		3,486			2,826			6,537			5,545
Other income (expense)
Interest income		58			12			119			22
Interest expense		(22	)		–			(22	)		–
Change in value of contingent consideration		(122	)		–			(243	)		–
Income (Loss) on currency exchange		23			(2	)		28			2
Total other income (expense)		(63	)		10			(118	)		24
Income before provision for income taxes		3,423			2,836			6,419			5,569
Provision for income taxes		(212	)		(686	)		(729	)		(1,361	)
Net income	$	3,211		$	2,150		$	5,690		$	4,208
Earnings per share
Basic	$	0.16		$	0.12		$	0.28		$	0.24
Diluted	$	0.15		$	0.12		$	0.27		$	0.23
Weighted-average common shares outstanding
Basic		20,006			17,638			19,968			17,624
Diluted		20,842			18,316			20,786			18,306
Other Comprehensive Income (Loss), net of tax
Foreign currency translation adjustments		(4	)		–			(4	)		–
Comprehensive Income	$	3,207		$	2,150		$	5,686		$	4,208

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EX-99.2

Exhibit 99.2

Earnings Call – Q2 FY21 Shawn O’Connor, CEO William Frederick, CFO April 12, 2021 (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

Quarter Highlights Strong performance across the board in 2 nd quarter Year over year r evenue growth of 27% for the quarter Profitability improvements with continued favorable revenue mix toward increased software contribution MIDD+ conference demonstrating industry leadership position Inaugural ESG report released reflecting commitment to good governance practices 3

Revenue Mix – Q2 (in millions) Total • 27% Y/Y growth • 12% Y/Y growth (excl. Lixoft) Software • 45% Y/Y growth • 15% Y/Y growth (excl. Lixoft) • 60% of total revenue Services • 7% Y/Y growth • 40% of total revenue 4 $4.7 $5.4 $7.8 $3.8 $5.0 $5.3 FY19 FY20 FY21 Software Services 55% 45% 48% 52% 60% 40% $8.5 $10.4 $13.1

Revenue Mix – YTD (in millions) Total • 21% Y/Y growth • 28% Y/Y growth (excl. DILIsym) Software • 40% Y/Y growth • 13% Y/Y growth (excl. Lixoft) • 59% of total revenue Services • 1% Y/Y growth • 41% of total revenue 5 $8.8 $10.0 $14.0 $7.2 $9.8 $9.8 FY19 FY20 FY21 Software Services 55% 45% 49% 51% 59% 41% $16 $19.8 $23.8

Growth & Profitability Metrics – Q2 * Pro forma non - GAAP numbers 6 15% 22% 27% 40% 34% 33% 55% 56% 60% 74% 74% 78% $0.12 $0.12 $0.15 FY19 FY20 FY21 Revenue growth % EBITDA % of revenue Rule of 40 Gross Margins Diluted EPS

Growth & Profitability Metrics – YTD * Pro forma non - GAAP numbers 7 11% 23% 21% 39% 35% 34% 50% 58% 55% 73% 73% 78% $0.20 $0.23 $0.27 FY19 FY20 FY21 Revenue growth % EBITDA % of revenue Rule of 40 Gross Margins Diluted EPS

Software Revenue by Product 8 57% 20% 16% 7% GastroPlus Monolix Suite ADMET Predictor Other Software Q2 FY21 Software Products as % of Software Revenue 56% 19% 17% 8% GastroPlus Monolix Suite ADMET Predictor Other Software YTD FY21

Software Highlights • Client Success – Successful progress with large pharma partner on AIDD lead optimization project; pipeline build of client candidates – Uptick in Monolix lead activity following release last quarter • New Products & Releases – GastroPlus V9.8.1 released – MonolixSuite R2020 training workshop conducted over 5 days with approximate 300 participants daily • Other – Extended software distributor network to South America and in China 9

Software Performance Metrics – Q2 Avg. Revenue per Customer (in thousands) 10 $41 $42 $66 $49 $54 $84 FY19 FY20 FY21 All Companies Commercial Companies Renewal Rates 92% 94% 93% 86% 88% 86% FY19 FY20 FY21 Fees Accounts

Software Performance Metrics – YTD Avg. Revenue per Customer (in thousands) 11 $45 $49 $71 $59 $67 $97 FY19 FY20 FY21 All Companies Commercial Companies Renewal Rates 93% 93% 93% 85% 88% 86% FY19 FY20 FY21 Fees Accounts

Services Revenue by Type 12 18% 32% 50% PBPK QSP/QST PKPD Q2 FY21 Services Types as % of Service Revenue 19% 29% 52% PBPK QSP/QST PKPD YTD FY21

Services Highlights • Significant large pharma PK/PD project in support of regulatory interactions • More than a dozen projects performed utilizing Monolix as primary analysis platform • 7 new PK/PD clients and 3 large project contracts with existing clients • Large QSP engagement in a new disease area • RENAsym Consortium announcement • Entered into large molecule safety collaboration • New funded collaboration to improve lung exposure models for pulmonary infection treatments • New funded collaboration to enhance GastroPlus ACAT model for oral absorption peptides • Provided grant to Makerere University (Uganda) in support of pharmacometrics education program 13

Services Performance Metrics 14 44 53 73 15 27 19 36 37 47 95 117 139 2Q19 2Q20 2Q21 Total Projects During Qtr. PKPD QSP/QST PBPK Backlog $12.7 $11.2 2Q20 2Q21 Backlog (in millions)

YTD Performance & FY21 Outlook • Total Revenue Growth – YTD performance: 21% growth – Full - year target range: 15 - 20% organic growth plus 3 - 5% from Lixoft • Software Revenue Growth – YTD performance: 40% growth – Full - year target range: 20 - 25% growth • Services Revenue Growth – YTD performance: 1% growth – Full - year target range: 25 - 30% growth • M&A Effort – Acquisitions would be incremental to revenue growth targets above – Focus: • Companies that extend our product portfolio • Companie s that provide new service capabilities/capacity • Companies that expand our geographic coverage 15

Financial Results

17 Income Statement Summar y – Q2 (in millions) FY21 % of Rev FY20 % of Rev Revenues $ 13.1 100% $ 10.4 100% Revenue Growth 27% 22% Gross profit 10.2 78% 7.7 74% SG&A 5.4 42% 4.1 40% R&D 1.3 10% 0.7 7% Total operating exp 6.7 51% 4.9 47% Income from operations 3.5 27% 2.8 27% Other income (expense) (0.1) (0)% 0.0 0% Income before income taxes 3.4 26% 2.8 27% Income taxes (0.2) 2% (0.7) 7% Effective tax rate 6% 24% Net income $ 3.2 24% $ 2.2 21% Diluted earnings per share (in dollars) $ 0.15 $ 0.12 EBITDA $ 4.3 33% $ 3.5 34%

18 Income Statement Summary – YTD (in millions) FY21 % of Rev FY20 % of Rev Revenues $ 23.8 100% $ 19.8 100% Revenue Growth 21% 23% Gross profit 18.5 78% 14.4 73% SG&A 9.9 41% 7.6 39% R&D 2.1 9% 1.3 6% Total operating exp 12.0 50% 8.9 45% Income from operations 6.5 27% 5.5 28% Other income (expense) (0.1) (0)% 0.0 0% Income before income taxes 6.4 27% 5.6 28% Income taxes 0.7 3% 1.4 7% Effective tax rate 11% 24% Net income $ 5.7 24% $ 4.2 21% Diluted earnings per share (in dollars) $ 0.27 $ 0.23 EBITDA $ 8.1 34% $ 6.9 35%

Gross Margin Trend – Q2 * Pro forma non - GAAP numbers 19 83% 85% 89% 63% 63% 61% 74% 74% 78% FY19 FY20 FY21 Software Services Total

Gross Margin Trend - YTD * Pro forma non - GAAP numbers 20 81% 84% 88% 62% 62% 63% 72% 73% 78% FY19 FY20 FY21 Software Services Total

21 Balance Sheet Summary (in millions, except where indicated) Feb. 28, 2021 Aug. 31, 2020 Cash and short - term investments $ 117.8 $ 116.0 Total current assets 135.6 129.1 Total assets 175.8 168.4 Current liabilities 6.5 5.5 Long - term liabilities 7.8 6.9 Total liabilities 14.3 12.4 Shareholders’ equity 161.5 156.0 Total liabilities and shareholders’ equity 175.8 168.4

Conclusion Q2 revenue growth strong and in line with FY21 outlook Richer mix of software revenues is enhancing our profitability metrics Reinforcing our biosimulation leadership with successful conference sponsorship and good market momentum with the close of new business, renewal and growth of existing relationships, key collaborations and grants Continued progress in our M&A efforts 22

Selected Financial Information Nasdaq SLP Cash and short - term investments $118 M Borrowed Debt Outstanding $0 Market Capitalization (a/o 4/05/21) $ 1.3B Fully Diluted Shares Outstanding 2Q21 20.8M Average Daily Trading Volume (current 30 day - a/o 4/05/21) ~210,000 23

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