Simulations Plus, Inc. - FORM 10-Q

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EX-32 - CERTIFICATION - Simulations Plus, Inc.	simulations_ex032.htm
EX-31.2 - CERTIFICATION - Simulations Plus, Inc.	simulations_ex3102.htm
EX-31.1 - CERTIFICATION - Simulations Plus, Inc.	simulations_ex3101.htm

Table of Contents

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

	☒	Quarterly Report Pursuant to Section 13 or 15(d) of the Security Exchange Act of 1934 for the quarterly period ended May 31, 2020

OR

	☐	Transmission Report Pursuant to Section 13 or 15(d) of the Security Exchange Act of 1937 for the transition period from ______ to ______

Commission file number: 001-32046

Simulations Plus, Inc.

(Name of registrant as specified in its charter)

California	95-4595609
(State or other jurisdiction of Incorporation or Organization)	(I.R.S. Employer identification No.)

42505 10^th Street West

Lancaster, CA 93534-7059

(Address of principal executive offices including zip code)

(661) 723-7723

(Registrant’s telephone number, including area code)

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 (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filings requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):

☐ Large accelerated filer	☒ Accelerated filer
☐ Non-accelerated filer (Do not check if a smaller reporting company)	☒ Smaller reporting company
☐ 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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of July 9, 2020 was 17,809,017, no shares of preferred stock were outstanding.

Simulations Plus, Inc.

FORM 10-Q

For the Quarterly Period Ended May 31, 2020

Table of Contents

PART I. FINANCIAL INFORMATION
		Page
Item 1.	Condensed Consolidated Financial Statements	3

	Condensed Consolidated Balance Sheets at May 31, 2020 (unaudited) and August 31, 2019 (audited)	3

	Condensed Consolidated Statements of Operations and Comprehensive Income for the three months and nine months ended May 31, 2020 and May 31, 2019 (unaudited)	4

	Condensed Consolidated Statements of Shareholders’ Equity for the nine months ended May 31, 2020 and the year ended August 31, 2019 (unaudited)	5

	Condensed Consolidated Statements of Cash Flows for the nine months ended May 31, 2020 and May 31, 2019 (unaudited)	6

	Notes to Condensed Consolidated Financial Statements (unaudited)	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Result of Operations	23

	General	23

	Result of Operations	32

	Liquidity and Capital Resources	36

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	36

Item 4.	Controls and Procedures	37

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	38

Item 1A.	Risk Factors	38

Item 2.	Changes in Securities	38

Item 3.	Defaults upon Senior Securities	38

Item 4.	Mine Safety Disclosures	38

Item 5.	Other Information	38

Item 6.	Exhibits	39

Signature		40

Part I. FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

	(Unaudited)		(Audited)
	May 31		August 31,
	2020		2019
ASSETS
Current assets
Cash and cash equivalents	$	7,354,496	$	11,435,499
Accounts receivable, net of allowance for doubtful accounts of $25,000 and $0		10,853,452		5,026,558
Revenues in excess of billings		2,838,072		3,233,659
Prepaid income taxes		392,099		765,110
Prepaid expenses and other current assets		745,468		704,316
Total current assets		22,183,587		21,165,142

Long-term assets
Capitalized computer software development costs,
net of accumulated amortization of $13,293,943 and $12,356,055		5,754,971		4,959,736
Property and equipment, net (note 4)		356,784		341,145
Operating lease right of use asset		1,019,408		–
Intellectual property, net of accumulated amortization of $4,729,270 and $3,948,750		12,275,730		5,026,249
Other intangible assets net of accumulated amortization of $1,503,481 and $1,210,000		7,146,519		3,280,000
Goodwill		12,792,171		10,387,198
Other assets		49,957		37,227
Total assets	$	61,579,127	$	45,196,697

LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable	$	663,337	$	204,075
Accrued payroll and other expenses		2,137,383		1,639,038
Current portion - Contracts payable (note 5)		3,761,028		1,761,028
Billings in excess of revenues		269,232		798,549
Operating lease liability, current portion		525,454		–
Deferred revenue		428,611		380,787
Total current liabilities		7,785,045		4,783,477

Long-term liabilities
Deferred income taxes, net		2,775,398		2,731,616
Operating Lease Liability		489,463		–
Payments due under Contracts payable (note 5)		3,942,333		–
Total liabilities		14,992,239		7,515,093

Commitments and contingencies (note 6)

Shareholders' equity (note 7)
Preferred stock, $0.001 par value 10,000,000 shares authorized no shares issued and outstanding	$	–	$	–
Common stock, $0.001 par value 50,000,000 shares authorized 17,788,498 and 17,591,834 shares issued and outstanding		7,791		7,595
Additional paid-in capital		20,231,443		15,319,474
Accumulated Other Comprehensive Income (Loss)		30,460		–
Retained earnings		26,317,194		22,354,535
Total shareholders' equity	$	46,586,888	$	37,681,604
Total liabilities and shareholders' equity	$	61,579,127	$	45,196,697

The accompanying notes are an integral part of these financial statements.

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

For the three and nine months ended May 31, 2020 and May 31, 2019

	Three months ended						Nine months ended
	(Unaudited)						(Unaudited)
	2020			2019			2020			2019
Revenues	$	12,298,036		$	9,936,921		$	32,049,003		$	25,944,545
Cost of revenues		2,665,405			2,324,188			7,974,702			6,734,890
Gross margin		9,632,630			7,612,733			24,074,301			19,209,655
Operating expenses
Selling, general, and administrative		5,023,132			3,087,445			12,646,512			8,613,788
Research and development		752,719			643,255			2,026,684			1,896,926
Total operating expenses		5,775,851			3,730,700			14,673,197			10,510,714

Income from operations		3,856,779			3,882,033			9,401,104			8,698,941

Other income (expense)
Interest income		4,465			11,050			27,814			20,296
Interest expense		–			(32,702	)		–			(109,078	)
Change in value of contingent consideration		(81,000	)		–			(81,000	)		–
(Loss) income on currency exchange		(602	)		(7,941	)		1,283			(40,467	)
Total other income (expense)		(77,137	)		(29,593	)		(51,902	)		(129,249	)

Income before provision for income taxes		3,779,642			3,852,440			9,349,202			8,569,692
Provision for income taxes		(844,073	)		(963,734	)		(2,205,276	)		(2,045,590	)
Net Income	$	2,935,569		$	2,888,706		$	7,143,925		$	6,524,102

Earnings per share
Basic	$	0.17		$	0.16		$	0.40		$	0.37
Diluted	$	0.16		$	0.16		$	0.39		$	0.36

Weighted-average common shares outstanding
Basic		17,735,354			17,519,849			17,661,189			17,472,922
Diluted		18,426,872			18,096,195			18,333,596			18,008,336

Other Comprehensive Income (Loss), net of tax
Foreign currency translation adjustments		30,460			–			30,460			–
Comprehensive Income (Loss)	$	2,966,029		$	2,888,706		$	7,174,385		$	6,524,102

The accompanying notes are an integral part of these financial statements.

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY

For the nine months ended May 31, 2020 and the year ended August 31, 2019

(UNAUDITED)

	Common Stock				Additional Paid-In		Accumulated Other Comprehensive		Retained
	Shares		Amount		Capital		Income		Earnings			Total

Balance, August 31, 2018		17,416,445	$	7,417	$	13,453,668	$	–	$	18,461,540		$	31,922,625

Exercise of stock options		41,103		42		357,410		–		–			357,452
Stock-based Compensation		–		–		200,029		–		–			200,029
Shares issued to Directors for services		2,222		2		44,904		–		–			44,906
Adjustment for 606		–		–		–		–		(493,279	)		(493,279	)
Declaration of Dividend		–		–		–		–		(1,045,073	)		(1,045,073	)
Net income		–		–		–		–		1,535,947			1,535,947
Balance, November 30, 2018		17,459,770		7,461		14,056,011		–		18,459,135			32,522,607

Exercise of stock options		37,680		38		121,912		–		–			121,950
Stock-based Compensation		–		–		208,715		–		–			208,715
Shares issued to Directors for services		2,508		4		48,954		–		–			48,958
Declaration of Dividend		–		–		–		–		(1,048,887	)		(1,048,887	)
Net income		–		–		–		–		2,099,449			2,099,449
Balance, February 28, 2019		17,499,958		7,503		14,435,592		–		19,509,697			33,952,792

Exercise of stock options		25,849		26		103,747		–		–			103,773
Stock-based Compensation		–		–		224,654		–		–			224,654
Shares issued to Directors for services		2,176		2		49,023		–		–			49,025
Declaration of Dividend		–		–		–		–		(1,050,914	)		(1,050,914	)
Net income		–		–		–		–		2,888,706			2,888,706
Balance, May 31, 2019		17,527,983		7,531		14,813,016		–		21,347,489			36,168,036

Exercise of stock options		62,071		62		204,910		–		–			204,972
Stock-based Compensation		–		–		232,450		–		–			232,450
Shares issued to Directors for services		1,780		2		69,098		–		–			69,100
Declaration of Dividend		–		–		–		–		(1,052,181	)		(1,052,181	)
Net income		–		–		–		–		2,059,227			2,059,227
Balance, August 31, 2019		17,591,834	$	7,595	$	15,319,474	$	–	$	22,354,535		$	37,681,604

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY

For the nine months ended May 31, 2020 and the year ended August 31, 2019

(UNAUDITED) (continued)

	Common Stock				Additional Paid-In		Accumulated Other Comprehensive		Retained
	Shares		Amount		Capital		Income		Earnings			Total
Balance, August 31, 2019		17,591,834	$	7,595	$	15,319,474	$	–	$	22,354,535		$	37,681,604

Exercise of stock options		29,445		29		135,529		–		–			135,558
Stock-based Compensation		–		–		294,704		–		–			294,704
Shares issued to Directors for services		2,045		2		72,411		–		–			72,413
Declaration of Dividend		–		–		–		–		(1,056,379	)		(1,056,379	)
Net income		–		–		–		–		2,058,277			2,058,277
Balance November 30, 2019		17,623,324		7,626		15,822,118		–		23,356,433			39,186,177

Exercise of stock options		22,915		23		167,168		–		–			167,191
Stock-based Compensation		–		–		344,928		–		–			344,928
Shares issued to Directors for services		2,225		2		72,488		–		–			72,490
Declaration of Dividend		–		–		–		–		(1,058,740	)		(1,058,740	)
Net income		–		–		–		–		2,150,080			2,150,080
Balance February 29, 2020		17,648,464		7,651		16,406,702		–		24,447,773			40,862,126

Exercise of stock options		26,447		26		204,581		–		–			204,607
Stock-based Compensation		–		–		287,115		–		–			287,115
Shares issued to Directors for services		1,905		2		72,483		–		–			72,485
Declaration of Dividend		–		–		–		–		(1,066,148	)		(1,066,148	)
Shares issued - Lixoft		111,682		112		3,260,562		–					3,260,674
Foreign Currency Translation Adjustments		–		–		–		30,460		–			30,460
Net income		–		–		–				2,935,569			2,935,569
Balance May 31, 2020		17,788,498	$	7,791	$	20,231,443	$	30,460	$	26,317,194		$	46,586,888

The accompanying notes are an integral part of these financial statements.

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the nine months ended May 31, 2020 and May 31, 2019

(UNAUDITED)

	2020			2019
Cash flows from operating activities
Net income	$	7,143,925		$	6,524,102
Adjustments to reconcile net income to net cash provided by operating activities
Depreciation and amortization		2,133,676			1,392,763
Change in value of contingent consideration		81,000			76,376
Stock-based compensation		1,144,135			502,605
Deferred income taxes		43,782			(149,623	)
(Increase) decrease in
Accounts receivable		(5,268,565	)		(713,027	)
Revenues in excess of billings		395,587			(278,922	)
Prepaid income taxes		553,462			312,593
Prepaid expenses and other assets		7,445			91,927
Increase (decrease) in
Accounts payable		324,427			(61,861	)
Accrued payroll and other expenses		26,653			(16,597	)
Billings in excess of revenues		(529,317	)		574,345
Accrued income taxes		–			106,845
Deferred revenue		47,824			214,897
Net cash provided by operating activities		6,104,034			8,576,423

Cash flows used in investing activities
Purchases of property and equipment		(105,784	)		(33,394	)
Purchases of intellectual property		–			(50,000	)
Cash used to acquire subsidiaries		(9,471,352	)		–
Cash received in acquisition		3,799,134			–
Capitalized computer software development costs		(1,733,124	)		(939,869	)
Net cash used in investing activities		(7,511,126	)		(1,023,263	)

Cash flows used in financing activities
Payment of dividends		(3,181,267	)		(2,093,960	)
Payments on Contracts Payable		–			(2,556,644	)
Proceeds from the exercise of stock options		507,356			479,402
Net cash used in financing activities		(2,673,911	)		(4,171,202	)

Net increase (decrease) in cash and cash equivalents		(4,081,003	)		3,381,958
Cash and cash equivalents, beginning of year		11,435,499			9,400,701
Cash and cash equivalents, end of period	$	7,354,496		$	12,782,659

Supplemental disclosures of cash flow information
Income taxes paid	$	1,613,868		$	781,838

Non-Cash Investing and Financing Activities
Stock issued for acquisition of Lixoft	$	3,260,674		$	–
Creation of contract liabilities for acquisition of subsidiaries	$	4,528,000		$	–
Non-Cash Investing and Financing Activities
Right of use assets capitalized	$	1,470,656		$	–

The accompanying notes are an integral part of these financial statements.

Simulations Plus, Inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

May 31, 2019

(Unaudited)

NOTE 1: GENERAL

This report on Form 10-Q for the quarter ended May 31, 2020 should be read in conjunction with the Company's annual report on Form 10-K for the year ended August 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2019. As contemplated by the SEC under Article 8 of Regulation S-X, the accompanying consolidated financial statements and footnotes have been condensed and therefore do not contain all disclosures required by generally accepted accounting principles. The interim financial data are unaudited; however, in the opinion of Simulations Plus, Inc. ("we", "our", "us"), the interim data includes all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the results for the interim periods. Results for interim periods are not necessarily indicative of those to be expected for the full year.

Organization

Simulations Plus, Inc. (“Simulations Plus”, “Lancaster”) was incorporated on July 17, 1996. On September 2, 2014, Simulations Plus, Inc. acquired all of the outstanding equity interests of Cognigen Corporation (“Cognigen”, “Buffalo”) and Cognigen became a wholly owned subsidiary of Simulations Plus, Inc. Simulations Plus, Inc., acquired DILIsym Services, Inc. (DILIsym) as a wholly owned subsidiary pursuant to a stock purchase agreement dated May 1, 2017. On June 1, 2017, the Company consummated the acquisition of all outstanding equity interests of DILIsym pursuant to the terms of the Stock Agreement, with DILIsym becoming a wholly owned subsidiary of the Company. On April 1, 2020, Simulations Plus, Inc. acquired Lixoft, a French société par actions simplifiée (“Lixoft”, “Paris”) as a wholly-owned subsidiary pursuant to a stock purchase and contribution agreement dated March 21, 2020. (Collectively, “Company”, “we”, “us”, “our”).

Lines of Business

The Company designs and develops pharmaceutical simulation software to promote cost-effective solutions to a number of problems in pharmaceutical research and in the education of pharmacy and medical students, and it provides consulting services to the pharmaceutical and chemical industries. Recently, the Company has begun to explore developing software applications for defense and for health care outside of the pharmaceutical industry.

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

The consolidated financial statements include the accounts of Simulations Plus, Inc. and, as of September 2, 2014, its wholly owned subsidiary, Cognigen Corporation, as of June 1, 2017, the accounts of DILIsym Services, Inc., and as of April 1, 2020, Lixoft accounts. All significant intercompany accounts and transactions are eliminated in consolidation.

Estimates

Our financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. These estimates and assumptions are affected by management’s application of accounting policies. Actual results could differ from those estimates. Significant accounting policies for us include revenue recognition, accounting for capitalized computer software development costs, valuation of stock options, and accounting for income taxes.

Reclassifications

Certain numbers in the prior year have been reclassified to conform to the current year's presentation.

Revenue Recognition

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09 and its related amendments regarding Accounting Standards Codification Topic 606 (ASC Topic 606), Revenue from Contracts with Customers. The standard provides principles for recognizing revenue for the transfer of promised goods or services to customers with the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard also provides guidance on the recognition of incremental costs related to obtaining customer contracts. We adopted ASC Topic 606, effective September 1, 2018, utilizing the modified retrospective method. This approach was applied to contracts that were in process as of September 1, 2018, and the corresponding incremental costs of obtaining those contracts, which resulted in a cumulative effect adjustment of $493,279 to the opening balance of retained earnings at the date of adoption. The adoption of this ASU primarily impacts the timing of our revenue recognition for certain sales contracts, the capitalization and amortization of incremental costs of obtaining a contract, and related disclosures. The reported results for fiscal year 2019 reflect the application of ASC Topic 606.

We generate revenue primarily from the sale of software licenses and providing consulting services to the pharmaceutical industry for drug development.

The Company determines revenue recognition through the following steps:

i.	Identification of the contract, or contracts, with a customer
ii.	Identification of the performance obligations in the contract
iii.	Determination of the transaction price
iv.	Allocation of the transaction price to the performance obligations in the contract
v.	Recognition of revenue when, or as, the Company satisfies a performance obligation

Deferred Commissions

Sales commissions earned by our sales force and our commissioned sales representatives are considered incremental and recoverable costs of obtaining a contract with a customer. Sales commissions for new contracts are deferred and then amortized on a straight-line basis over a period of benefit. We determined the period of benefit by taking into consideration our customer contracts, our technology and other factors. Sales commissions for renewal contracts are deferred and then amortized on a straight-line basis over the related contractual renewal period. Amortization expense is included in sales and marketing expenses on the condensed consolidated statements of operations.

We apply the practical expedient in ASC Topic 606 to expense costs as incurred for sales commissions when the period of benefit would have been one year or less. Most of our contracts are of a duration of one year or less, few, if any of the longer-term contracts have commissions associated with them.

Practical Expedients and Exemptions

The Company has elected the following additional practical expedients in applying Topic 606:

Commission Expense: We apply the practical expedient in ASC Topic 606 to expense costs as incurred for sales commissions when the period of benefit is one year or less. Most of our contracts are of a duration of one year or less, few, if any of the longer term contracts have commissions associated with them.

Transaction Price Allocated to Future Performance Obligations

ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of May 31, 2020. ASC 606 provides certain practical expedients that limit the requirement to disclose the aggregate amount of transaction price allocated to unsatisfied performance obligations.

The Company applied the practical expedient to not disclose the amount of transaction price allocated to unsatisfied performance obligations when the performance obligation is part of a contract that has an original expected duration of one year or less.

Cash and Cash Equivalents

For purposes of the statements of cash flows, the Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents.

Accounts Receivable

We analyze the age of customer balances, historical bad-debt experience, customer creditworthiness, and changes in customer payment terms when making estimates of the collectability of the Company’s trade accounts receivable balances. If we determine that the financial conditions of any of our customers deteriorated, whether due to customer-specific or general economic issues, an increase in the allowance may be made. Accounts receivable are written off when all collection attempts have failed.

Capitalized Computer Software Development Costs

Software development costs are capitalized in accordance with ASC 985-20, “Costs of Software to Be Sold, Leased, or Marketed”. Capitalization of software development costs begins upon the establishment of technological feasibility and is discontinued when the product is available for sale.

The establishment of technological feasibility and the ongoing assessment for recoverability of capitalized software development costs require considerable judgment by management with respect to certain external factors including, but not limited to, technological feasibility, anticipated future gross revenues, estimated economic life, and changes in software and hardware technologies. Capitalized software development costs are comprised primarily of salaries and direct payroll-related costs and the purchase of existing software to be used in our software products.

Amortization of capitalized software development costs is calculated on a product-by-product basis using the straight-line method over the estimated economic life of the products (not to exceed five years). Amortization of software development costs amounted to $310,218 and $322,552 for the three months ended May 31, 2020 and 2019, respectively, and $937,888 and $1,006,339 for the nine months ended May 31, 2020 and 2019, respectively. We expect future amortization expense to vary due to increases in capitalized computer software development costs.

We test capitalized computer software development costs for recoverability whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

Property and Equipment

Property and equipment are recorded at cost, less accumulated depreciation and amortization. Depreciation and amortization are provided using the straight-line method over the estimated useful lives as follows:

Equipment	5 years
Computer equipment	3 to 7 years
Furniture and fixtures	5 to 7 years
Leasehold improvements	Shorter of life of asset or lease

Maintenance and minor replacements are charged to expense as incurred. Gains and losses on disposals are included in the results of operations.

Leases

In February 2016, the FASB issued ASU No. 2016-02—Leases, to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. The recognition, measurement and presentation of expenses and cash flows arising from a lease by a lessor have not significantly changed from previous U.S. GAAP. This ASU was effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2018. We adopted this ASU on September 1, 2019.

We lease various production, administrative and sales offices under operating leases. We evaluate our contracts to determine if an arrangement is a lease at inception and classify it as a finance or operating lease. Currently, all our leases are classified as operating leases. Leased assets and corresponding liabilities are recognized based on the present value of the lease payments over the lease term. Our lease terms may include options to extend when it is reasonably certain that we will exercise that option. Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease. With the adoption of ASC 842 on September 1, 2019, we recognized all leases with terms greater than 12 months in duration on our consolidated balance sheets as right-of-use assets and lease liabilities. We adopted the standard using the prospective approach and did not retrospectively apply to prior periods. Right-of-use assets are recorded in long-term assets on our consolidated balance sheets. Current and non-current lease liabilities are recorded as operating lease liabilities within current liabilities and long-term liabilities, respectively, on our consolidated balance sheets. As part of the adoption of this standard we recorded the following assets and liabilities as of September 1, 2019:

Right of use assets	$	902,553
Lease Liabilities, Current	$	537,017
Lease Liabilities, Long-term	$	365,536

We have made certain assumptions and judgments when applying ASC 842, the most significant of which are:

	·	We elected the package of practical expedients available for transition that allow us to not reassess whether expired or existing contracts contain leases under the new definition of a lease, lease classification for expired or existing leases and whether previously capitalized initial direct costs would qualify for capitalization under ASC 842.
	·	We did not elect to use hindsight when considering judgments and estimates such as assessments of lessee options to extend or terminate a lease or purchase the underlying asset.
	·	For all asset classes, we elected to not recognize a right-of-use asset and lease liability for short-term leases.
	·	The determination of the discount rate used in a lease is our estimated incremental borrowing rate that is based on what we would expect to pay to borrow over a similar term an amount equal to the lease payments.

Supplemental balance sheet information related to operating leases was as follows as of May 31, 2020:

Right of use asset	$	1,019,408
Lease Liabilities, Current	$	525,454
Lease Liabilities, Long-term	$	489,463
Operating lease costs	$	438,269
Weighted Average remaining lease term		2.31 years
Weighted Average Discount rate		4.28%

Goodwill and indefinite-lived assets

The Company performs valuations of assets acquired and liabilities assumed on each acquisition accounted for as a business combination and recognizes the assets acquired and liabilities assumed at their acquisition date fair value. Acquired intangible assets include customer relationships, software, trade names, and non-compete agreements. The Company determines the appropriate useful life by performing an analysis of expected cash flows based on historical experience of the acquired businesses. Intangible assets are amortized over their estimated useful lives using the straight-line method, which approximates the pattern in which the majority of the economic benefits are expected to be consumed.

Goodwill represents the excess of the cost of an acquired entity over the fair value of the acquired net assets. Goodwill is not amortized, instead it is tested for impairment annually or when events or circumstances change that would indicate that goodwill might be impaired. Events or circumstances that could trigger an impairment review include, but are not limited to, a significant adverse change in legal factors or in the business climate, an adverse action or assessment by a regulator, unanticipated competition, a loss of key personnel, significant changes in the manner of the Company's use of the acquired assets or the strategy for the Company's overall business, significant negative industry or economic trends, or significant underperformance relative to expected historical or projected future results of operations.

Goodwill is tested for impairment at the reporting unit level, which is one level below or the same as an operating segment. As of May 31, 2020, the Company determined that it has four reporting units, Simulations Plus, Cognigen Corporation, DILIsym Services, Inc. and Lixoft. When testing goodwill for impairment, the Company first performs a qualitative assessment to determine whether it is necessary to perform step one of a two-step annual goodwill impairment test for each reporting unit. The Company is required to perform step one only if it concludes that it is more likely than not that a reporting unit's fair value is less than its carrying value. Should this be the case, the first step of the two-step process is to identify whether a potential impairment exists by comparing the estimated fair values of the Company's reporting units with their respective book values, including goodwill. If the estimated fair value of the reporting unit exceeds book value, goodwill is considered not to be impaired, and no additional steps are necessary. If, however, the fair value of the reporting unit is less than book value, then the second step is performed to determine if goodwill is impaired and to measure the amount of impairment loss, if any. The amount of the impairment loss is the excess of the carrying amount of the goodwill over its implied fair value. The estimate of implied fair value of goodwill is primarily based on an estimate of the discounted cash flows expected to result from that reporting unit but may require valuations of certain internally generated and unrecognized intangible assets such as the Company's software, technology, patents, and trademarks. If the carrying amount of goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to the excess.

As of May 31, 2020, the entire balance of goodwill was attributed to three of the Company's reporting units, Cognigen Corporation, DILIsym Services, and Lixoft. Intangible assets subject to amortization are reviewed for impairment whenever events or circumstances indicate that the carrying amount of these assets may not be recoverable. The Company did not recognize any impairment charges, during the three-month and nine-month periods ended May 31, 2020 and 2019.

Reconciliation of Goodwill for the period ended May 31, 2020:

	Cognigen		DILIsym		Lixoft		Total
Balance, August 31, 2019	$	4,789,248	$	5,597,950	$	–	$	10,387,198
Addition		–		–		2,404,973		2,404,973
Impairments		–		–		–		–
Balance, May 31, 2020	$	4,789,248	$	5,597,950	$	2,404,973	$	12,792,171

Fair Value of Financial Instruments

Assets and liabilities recorded at fair value in the Condensed Balance Sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair value. The categories, as defined by the standard are as follows:

Level Input:		Input Definition:
Level I		Inputs are unadjusted, quoted prices for identical assets or liabilities in active markets at the measurement date.
Level II		Inputs, other than quoted prices included in Level I, that are observable for the asset or liability through corroboration with market data at the measurement date.
Level III		Unobservable inputs that reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.

For certain of our financial instruments, including accounts receivable, accounts payable, accrued payroll and other expenses, accrued bonus to officer, and accrued warranty and service costs, the amounts approximate fair value due to their short maturities.

The following table summarizes fair value measurements at May 31, 2020 and August 31, 2019 for assets and liabilities measured at fair value on a recurring basis:

May 31, 2020:

	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	7,354,496	$	–	$	–	$	7,354,496
Acquisition-related contingent consideration obligations	$	–	$	–	$	6,370,028	$	6,370,028

August 31, 2019:

	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	11,435,499	$	–	$	–	$	11,435,499
Acquisition-related contingent consideration obligations	$	–	$	–	$	1,761,028	$	1,761,028

As of May 31, 2020, and August 31, 2019, the Company has a liability for contingent consideration related to its acquisitions of the DILIsym Services, Inc. and Lixoft. The fair-value measurement of the contingent consideration obligations is determined using Level 3 inputs. The fair value of contingent consideration obligations is based on a discounted cash flow model using a probability-weighted income approach. These fair-value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market. Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, changes in assumptions could have a material impact on the amount of contingent consideration expense the Company records in any given period. Changes in the value of the contingent consideration obligations are recorded in the Company’s Consolidated Statement of Operations.

As of May 31, 2020, the Company has a liability for contingent consideration related to its acquisitions of DILIsym Services, Inc. and Lixoft:

The following is a reconciliation of contingent consideration value.

Value at August 31, 2019	$	1,761,028
Contingent consideration for Lixoft		4,609,000
Value at May 31, 2020	$	6,370,028

Research and Development Costs

Research and development costs are charged to expense as incurred until technological feasibility has been established. These costs include salaries, laboratory experiment, and purchased software that was developed by other companies and incorporated into, or used in the development of, our final products.

Income Taxes

The Company accounts for income taxes in accordance with ASC 740-10, “Income Taxes” which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns.

Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. The provision for income taxes represents the tax payable for the period and the change during the period in deferred tax assets and liabilities.

Intellectual property

On February 28, 2012, we bought out a royalty agreement with Enslein Research of Rochester, New York. The cost of $75,000 is being amortized over 10 years under the straight-line method. Amortization expense for each of the three-month periods ended May 31, 2020 and 2019 was $1,875 and was $5,625 for each of the nine-month periods ended May 31, 2020, and 2019. Accumulated amortization as of May 31, 2020 and August 31, 2019 were $61,875 and $56,250, respectively.

On May 15, 2014, we entered into a termination and nonassertion agreement with TSRL, Inc., pursuant to which the parties agreed to terminate an exclusive software licensing agreement entered into between the parties in 1997. As a result, the company obtained a perpetual right to use certain source code and data, and TSRL relinquished any rights and claims to any GastroPlus products and to any claims to royalties or other payments under that 1997 agreement. We agreed to pay TSRL total consideration of $6,000,000, which is being amortized over 10 years under the straight-line method. Amortization expense for each of the three-month periods ended May 31, 2020 and 2019 was $150,000, and $450,000 for each of the nine-month periods ended May 31, 2020 and 2019. Accumulated amortization as of May 31, 2020 and August 31, 2019 were $3,625,000 and $3,175,000, respectively.

On June 1, 2017, as part of the acquisition of DILIsym Services, Inc. the Company acquired certain developed technologies associated with the drug induced liver disease (DILI). These technologies were valued at $2,850,000 and are being amortized over 9 years under the straight-line method. Amortization expense for the three months and nine months ended May 31, 2020 and May 31, 2019 was $79,167 and $237,501, respectively, and is included in cost of revenues. Accumulated amortization as of May 31, 2020 and August 31, 2019 were $950,000 and $712,513, respectively.

In September 2018, we purchased certain intellectual property rights of Entelos Holding Company, a Delaware Corporation. The cost of $50,000 is being amortized over 10 years under the straight-line method. Amortization expense for the three months and nine months period ended May 31, 2020 and May 31, 2019 was $1,250 and $3,750, respectively. Accumulated amortization as of May 31, 2020 and August 31, 2019 was $8,750 and $5,000 respectively.

On April 1, 2020, as part of the acquisition of Lixoft the Company acquired certain developed technologies associated with the non-linear mixed effed models, population analysis, pharmacometrics and pre-clinical and clinical trial modeling and simulation algorithms. These technologies were valued at $8,030,000 and are being amortized over 16 years under the straight-line method. Amortization expense for the two months from acquisition to May 31, 2020 was $83,644, and is included in cost of revenues. Accumulated amortization as of May 31, 2020 was $83,644.

Total amortization expense for intellectual property agreements for the three months ended May 31, 2020 and 2019 was $315,936 and $232,292, respectively, and total amortization expense for the nine months ended May 31, 2020 and 2019 was $780,520 and $696,876 respectively. Accumulated amortization as of May 31, 2020 was $4,729,270 and $3,948,750 as of August 31, 2019.

Intangible assets

The following table summarizes intangible assets as of May 31, 2020:

	Amortization Period	Acquisition Value		Accumulated Amortization		Net book value
Customer relationships-Cognigen	Straight line 8 years	$	1,100,000	$	790,625	$	309,375
Trade Name-Cognigen	None		500,000		0		500,000
Covenants not to compete-Cognigen	Straight line 5 years		50,000		50,000		0
Covenants not to compete-DILIsym	Straight line 4 years		80,000		60,000		20,000
Trade Name-DILIsym	None		860,000		0		860,000
Customer relationships-DILIsym	Straight line 10 years		1,900,000		570,000		1,330,000
Customer relationships-Lixoft	Straight line 14 years		2,550,000		30,356		2,519,644
Trade Name-Lixoft	None		1,550,000		0		1,550,000
Covenants not to compete-Lixoft	Straight line 4 years		60,000		2,500		57,500
		$	8,650,000	$	1,503,481	$	7,146,519

Amortization expense for each of the three-month and nine-month periods ended May 31, 2020 and May 31, 2019 was $119,731 and $293,481 as compared to $89,375 and $268,125, respectively. According to policy, in addition to normal amortization, these assets are tested for impairment as needed.

Earnings per Share

We report earnings per share in accordance with FASB ASC 260-10. Basic earnings per share is computed by dividing income available to common shareholders by the weighted-average number of common shares available. Diluted earnings per share computation is similar to basic earnings per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. The components of basic and diluted earnings per share for the three and nine months ended May 31, 2020 and 2019 were as follows:

	Three months ended				Nine months ended
	5/31/2020		5/31/2019		5/31/2020		5/31/2019
Numerator:
Net income attributable to common shareholders	$	2,935,569	$	2,888,706	$	7,143,925	$	6,524,102
Denominator:
Weighted-average number of common shares outstanding during the period		17,735,354		17,519,849		17,661,189		17,472,922
Dilutive effect of stock options		691,518		576,346		672,407		535,414
Common stock and common stock equivalents used for diluted earnings per share		18,426,872		18,096,195		18,333,596		18,008,336

Stock-Based Compensation

Compensation costs related to stock options are determined in accordance with FASB ASC 718-10, “Compensation-Stock Compensation”, using the modified prospective method. Under this method, compensation cost is calculated based on the grant-date fair value estimated in accordance with FASB ASC 718-10, amortized on a straight-line basis over the options’ vesting period. Stock-based compensation was $287,115 and $224,654 for the three months ended May 31, 2020 and 2019, respectively and $926,747 and $633,398 for the nine months ended May 31, 2020 and 2019, respectively. This expense is included in the condensed consolidated statements of operations as Selling, General, and Administration (SG&A), and Research and Development expense.

Impairment of Long-lived Assets

The Company accounts for the impairment and disposition of long-lived assets in accordance with ASC 350, “Intangibles – Goodwill and Other” and ASC 360, “Property and Equipment”. Long-lived assets to be held and used are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable. We measure recoverability by comparing the carrying amount of an asset to the expected future undiscounted net cash flows generated by the asset. If we determine that the asset may not be recoverable, or if the carrying amount of an asset exceeds its estimated future undiscounted cash flows, we recognize an impairment charge to the extent of the difference between the fair value and the asset's carrying amount. No impairment losses were recorded during the nine months ended May 31, 2020 and 2019.

Recently Issued Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes existing guidance on accounting for leases in "Leases (Topic 840)" and generally requires all leases to be recognized in the consolidated balance sheet. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018; early adoption is permitted. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.

In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606), which amends certain aspects of the Board's new revenue standard, ASU 2014-09, Revenue from Contracts with Customers. The standard was adopted concurrently with the adoption of ASU 2014-09 which is effective for annual and interim periods beginning after December 15, 2017.

NOTE 3. REVENUE RECOGNITION

The Company adopted Topic 606 effective September 1, 2018 using the modified retrospective method applying this guidance to all open contracts at the date of initial application, which resulted in an adjustment to retained earnings for the cumulative effect of applying this guidance. The most significant impact of Topic 606 on revenue to the Company relates to the timing of revenue recognition for one of its payment contracts. Under 606 the revenues under the contract are being recognized as time is expended and costs are being expensed as incurred. Under ASC 605 revenues were recognized as invoiced and certain costs were capitalized as development.

We generate revenue primarily from the sale of software licenses and providing consulting services to the pharmaceutical industry for drug development.

The Company determines revenue recognition through the following steps:

i.	Identification of the contract, or contracts, with a customer
ii.	Identification of the performance obligations in the contract
iii.	Determination of the transaction price
iv.	Allocation of the transaction price to the performance obligations in the contract
v.	Recognition of revenue when, or as, the Company satisfies a performance obligation

The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. Contracts generally have fixed pricing terms and are not subject to variable pricing. The Company considers the nature and significance of each specific performance obligation under a contract when allocating the proceeds under each contract. Accounting for contracts includes significant judgement in the estimation of estimated hours/cost to be incurred on consulting contracts, and the di minimis nature of the post sales costs associated with software sales.

Components of revenue

The following is a description of principal activities from which the Company generates revenue. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Stand-alone selling prices are determined based on the prices at which the Company separately sells its services or goods.

Revenue Components

Typical payment terms

Software Revenues:

Software revenues are generated primarily from sales of software licenses at the time the software is unlocked and the term commences. The license period typically is one year or less. Along with the license a di minimis amount of customer support is provided to assist the customer with the software. Should the customer need more than a di minimis amount of support they can choose to enter into a separate contract for additional training. Most software is installed on our customers' servers and the Company has no control of the software once the sale is made.

For certain software arrangements the Company hosts the licenses on servers maintained by the Company, revenue for those arrangements are accounted as Software as a Service over the life of the contract. These arrangements are a small portion of software revenues of the Company.

Payments are generally due upon invoicing on a net 30 basis unless other payment terms are negotiated with the customer based on customer history. Typical industry standards apply.


Consulting Contracts: Consulting services provided to our customers are generally recognized over time as the contracts are performed and the services are rendered. The company measures its consulting revenue based on time expended compared to total estimated hours to complete a project. The Company believes the methods chosen for its contract revenue best depicts the transfer of benefits to the customer under the contracts.		Payment terms vary, depending on the size of the contract, credit history and history with the client and deliverables within the contract.

Consortium Member Based Services: The performance obligation is recognized on a time elapsed basis, by month, for which the services are provided, as the Company transfers control evenly over the contractual period.		Payment is due at the beginning of the period, generally on a net 30 or 60 basis.

Remaining performance obligations that do not fall under the expedients require the Company to perform various consulting and software development services and consortium memberships of approximately $2,700,000. It is anticipated these revenues will be recognized within the next two and ½ years.

Contract liabilities

During the three months and nine months period ended May 31, 2020 the Company recognized $109,000 and $882,000 of revenue that was included in contract liabilities as of August 31, 2019.

Disaggregation of Revenues

Disaggregation of Revenues:	Three Months Ended May 31, 2020		Nine Months Ended May 31, 2020
Software licenses
Point in time	$	6,622,671	$	16,116,466
Over time		230,047		734,339
Consulting services
Over time		5,445,318		15,198,198
Total Revenue	$	12,298,036	$	32,049,003

NOTE 4: Property and Equipment

Property and equipment as of May 31, 2020 consisted of the following:

Equipment	$	775,767
Computer equipment		510,935
Furniture and fixtures		160,990
Leasehold improvements		114,004
Sub total		1,561,696
Less: Accumulated depreciation and amortization		(1,204,912	)
Net Book Value	$	356,784

NOTE 5: CONTRACTS PAYABLE

DILIsym Acquisition Liabilities:

On June 1, 2017, the Company acquired DILIsym Services, Inc. The agreement provided for a working capital adjustment, an eighteen-month $1,000,000 holdback provision against certain representations and warrantees, and an Earn-out agreement of up to an additional $5,000,000 in Earn-out payments based on earnings over the next three years. The Earn-out liability has been recorded at an estimated fair value. Payments under the Earn-out liability started in FY 2019. In September 2018, $1,556,644 was paid out under the first earn-out payment, a second earn-out payment was made in August 2019 in the amount of $1,682,329. It is estimated that a final payment of approximately $1,761,028 will be paid in August 2020.

Lixoft Acquisition Liabilities:

On April 1, 2020, the Company acquired Lixoft. The agreement provided for a twenty-four month $2,000,000 holdback provision against certain representations and warrantees, comprised of $1,333,333 of cash and the release from an escrow shares of stock valued at $666,337 issued at the date of the Agreement. In addition, based on a revenue growth formula for the two years subsequent to April 1, 2020, the agreement calls for earn-out payments up to $5,500,000 (two thirds cash and one-third newly issued, unregistered shares of the Company’s common stock). The former shareholders can earn up to $2,000,000 the first year and $3,500,000 in year two.

As of May 31, 2020 and August 31, 2019 the following liabilities have been recorded:

	May 31, 2020		August 31, 2019
Holdback Liability - Lixoft	$	1,333,333	$	–
Earn-out Liability - Lixoft		4,609,000		–
Earn-out Liability - Dilisym		1,761,028		1,761,028
Sub Total	$	7,703,361	$	1,761,028
Less: Current Portion		3,761,028		1,761,028
Long-Term	$	3,942,333	$	–

NOTE 6: COMMITMENTS AND CONTINGENCIES

Leases

We lease approximately 13,500 square feet of space in Lancaster, California. The original lease had a five-year term with two, three-year options to extend. The initial five-year term expired in February 2011, and we extended the lease to February 2, 2014. In June 2013, the lease was amended to extend the term to February 2, 2017. The amended lease also provides for an annual base rent increase of 3% per year and two, two-year options to extend. In May 2016 the Company exercised the two, two-year options extending the term of the lease through February 2, 2021 at a fixed rate of $25,000 per month. The new extension agreement allowed the Company with 90 days’ notice to opt out of the remaining lease in the last two years of the term upon payment of a recapture payment equal to the 3% base payment increase that would have been due under the original agreement.

Our Buffalo subsidiary leases approximately 12,623 square feet of space in Buffalo, New York. The initial five-year term expired in October 2018; and was renewed for a three-year option to extending it to October 2021. The new base rent is $16,147 per month.

DILIsym leases approximately 2,700 square feet of space in Research Triangle Park, North Carolina. The initial three-year term was due to expire October 2020. An amendment to the initial lease became effective April 1, 2020. This amendment added 686 square feet and extended the term of the lease to September 30, 2023. The new base rent is $7,500 per month with an annual 3% adjustment.

In Paris, France Lixoft leases approximately 2,300 square feet of office space, which as of April 1, 2020, had minimum payments equaling $229,843. The lease is for a 9-year term, with an option to terminate every 3 years, and expires in November of 2024. The rent is $16,555 per quarter and can be adjusted each December based on a consumer price index.

Rent expense, including common area maintenance fees for the three months ended May 31, 2020, and 2019 was $168,381 and $147,581, respectively, and $463,074 and $436,357 for the nine months ended May 31, 2020 and 2019, respectively.

Future minimum lease payments under non-cancelable operating leases with remaining terms of one year or more at May 31, 2020 were as follows:

Years Ending May 31,
2021	$	560,554
2022		268,440
2023		174,719
2024		64,118
	$	1,067,831

Line of Credit

On March 31, 2020, Simulations Plus, Inc. entered into a Credit Agreement with Wells Fargo Bank, N.A. The Credit Agreement, has provided Simulations Plus, Inc. with a credit facility of $3,500,000 through April 15, 2022. As of May 31, 2020, there were no amounts drawn against the line of credit.

Employment Agreements

In the normal course of business, the Company has entered into employment agreements with certain of its key management personnel that may require compensation payments upon termination.

License Agreement

The Company had a royalty agreement with Dassault Systèmes Americas Corp. for access to their Metabolite Database for developing our Metabolite Module within ADMET Predictor™. The module was renamed the Metabolism Module when we released ADMET Predictor version 6 on April 19, 2012. Under this agreement, we paid a royalty of 25% of revenue derived from the sale of the Metabolism/Metabolite module. This agreement was recently renegotiated, and the Company does not bear any royalty obligations towards Dassault Systèmes Americas Corp. effective as of June 30, 2019. In addition, the license agreement will terminate on September 5, 2020. We incurred royalty expense (benefit) of ($137,496) and $55,924, respectively, for the three months ended May 31, 2020 and 2019, respectively and ($26,055) and $147,495 for the nine months ended May 31, 2020 and 2019, respectively.

Income Taxes

We follow guidance issued by the FASB with regard to our accounting for uncertainty in income taxes recognized in the financial statements. Such guidance prescribes a recognition threshold of more likely than not and a measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. In making this assessment, a company must determine whether it is more likely than not that a tax position will be sustained upon examination, based solely on the technical merits of the position and must assume that the tax position will be examined by taxing authorities. Our policy is to include interest and penalties related to unrecognized tax benefits in income tax expense. Interest and penalties totaled $-0- for fiscal year 2019. We file income tax returns with the IRS and various state jurisdictions, India and France for our Paris division. Our federal income tax returns for fiscal years 2016 through 2018 are open for audit, and our state tax returns for fiscal year 2015 through 2018 remain open for audit. In addition, certain elements of prior tax years, such as R&D credits, may remain open and may be subject to future audit.

Our review of prior year tax positions using the criteria and provisions presented in guidance issued by FASB did not result in a material impact on our financial position or results of operations.

Litigation

We are not a party to any legal proceedings and are not aware of any pending legal proceedings of any kind.

NOTE 7: SHAREHOLDERS’ EQUITY

Dividend

The Company’s Board of Directors declared cash dividends during fiscal years 2020 and 2019. The details of the dividends paid are in the following tables:

FY2020
Record Date	Distribution Date	Number of Shares Outstanding on Record Date		Dividend per Share		Total Amount
10/25/2019	11/01/2019		17,606,314	$	0.06	$	1,056,379
1/27/2020	2/03/2020		17,645,639	$	0.06		1,058,740
4/24/2020	5/01/2020		17,769,134	$	0.06		1,066,148
Total						$	3,181,267

FY2019
Record Date	Distribution Date	Number of Shares Outstanding on Record Date		Dividend per Share		Total Amount
11/1/2018	11/08/2018		17,417,875	$	0.06	$	1,045,073
1/25/2019	2/1/2019		17,481,450	$	0.06		1,048,887
4/09/2019	5/01/2019		17,515,228	$	0.06		1,050,914
7/25/2019	8/1/2019		17,536,454	$	0.06		1,052,181
Total						$	4,197,055

Stock Option Plan

On February 23, 2007, the Board of Directors adopted, and the shareholders approved the 2007 Stock Option Plan under which a total of 1,000,000 shares of common stock had been reserved for issuance. On February 25, 2014, the shareholders approved an additional 1,000,000 shares increasing the total number of shares that may be granted under the Option Plan to 2,000,000. This plan terminated in February 2017 by its term.

On December 23, 2016 the Board of Directors adopted, and on February 23, 2017 the shareholders approved, the 2017 Equity Incentive Plan under which a total of 1,000,000 shares of common stock has been reserved for issuance. This plan will terminate in December 2026.

As of May 31, 2020, employees and directors hold stock options to purchase 1,231,491 shares of common stock at exercise prices ranging from $6.75 to $38.81.

The following table summarizes information about stock options:

Transactions in FY20	Number of Options			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Life
Outstanding, August 31, 2019		1,163,259		$	12.63		7.13
Granted		180,000		$	33.83
Exercised		(78,807	)	$	8.46
Cancelled/Forfeited		(32,961	)	$	14.26
Expired		–		$	–
Outstanding, May 31, 2020		1,231,491		$	15.95		6.90
Exercisable, May 31, 2020		625,966		$	10.05		5.78

The weighted-average remaining contractual life of options outstanding issued under the Plan, both Qualified ISO and Non-Qualified SO, was 6.88 years at May 31, 2020. The total fair value of non-vested stock options as of May 31, 2020 was $17,328,000 and is amortizable over a weighted average period of 3.46 years.

The fair value of these options was estimated at the date of grant using the Black-Scholes option-pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which do not have vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility. Because our stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its stock options.

The following table summarizes the fair value of the options, including both ISOs and NQSOs, granted during the current fiscal year 2020 and fiscal year 2019:

	YTD FY 2020		FY 2019
Estimated fair value of awards granted	$	1,996,200	$	1,928,820
Unvested Forfeiture Rate		0%		6.20%
Weighted average grant price	$	33.83	$	22.78
Weighted average market price	$	33.83	$	22.69
Weighted average volatility		32.27%		31.61%
Weighted average risk-free rate		1.62%		2.59%
Weighted average dividend yield		0.71%		1.10%
Weighted average expected life		6.68 years		6.64 years

The exercise prices for the options outstanding at May 31, 2020 ranged from $6.75 to $38.81, and the information relating to these options is as follows:

Exercise Price				Awards Outstanding						Awards Exercisable
Low		High		Quantity		Weighted Average Remaining Contractual Life		Weighted Average Exercise Price		Quantity		Weighted Average Remaining Contractual Life		Weighted Average Exercise Price
$	6.75	$	8.00		180,970		4.27 years	$	6.85		180,970		4.27 years	$	6.85
$	8.01	$	16.00		588,401		6.29 years	$	9.97		387,846		6.21 years	$	9.93
$	16.01	$	24.00		236,870		8.03 years	$	20.69		57,150		7.60 years	$	21.06
$	24.01	$	38.81		225,250		9.43 years	$	33.92		0		–	$	–
					1,231,491		6.90 years	$	15.95		625,966		5.78 years	$	10.05

During the three and nine-month periods ended May 31, 2020, the Company issued 1,905 and 6,175 shares of stock to non-management directors of the Company valued at $72,483 and $217,382, respectively as compensation for services rendered to the Company.

NOTE 8: CONCENTRATIONS AND UNCERTAINTIES

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash, cash equivalents, and trade accounts receivable. The Company holds cash and cash equivalents at banks located in California and North Carolina with balances that often exceed FDIC insured limits. Historically, the Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk on cash and cash equivalents. However, considering the current banking environment, the Company is investigating alternative ways to minimize its exposure to such risks. While the Company may be exposed to credit losses due to the nonperformance of its counterparties, the Company does not expect the settlement of these transactions to have a material effect on its results of operations, cash flows, or financial condition. The Company maintains cash at financial institutions that may, at times, exceed federally insured limits. At May 31, 2020 the Company had cash and cash equivalents exceeding insured limits by approximately $6,300,000.

Revenue concentration shows that international sales accounted for 32% and 36% of net sales for the nine months ended May 31, 2020 and 2019, respectively. Three customers accounted for 8%, 7% (a dealer account in Japan representing various customers), and 7% of net sales during the nine months ended May 31, 2020. Three customers accounted for 9%, 8% (a dealer account in Japan representing various customers), and 7% of net sales during the nine months ended May 31, 2019.

Accounts receivable concentration shows that seven customers comprised 10% (a dealer account in Japan representing various customers), 7%, 7%, 7%, 5%, 5% and 5% of accounts receivable at May 31, 2020, compared to five customers comprised 10% (a dealer account in Japan representing various customers), 9%, 8%, 5% and 5% of accounts receivable at May 31, 2019

We operate in the computer software industry, which is highly competitive and changes rapidly. Our operating results could be significantly affected by our ability to develop new products and find new distribution channels for new and existing products.

The majority of our customers are in the pharmaceutical industry. Consolidation and downsizing in the pharmaceutical industry could have an impact on our revenues and earnings going forward.

NOTE 9: SEGMENT AND Geographic Reporting

We account for segments and geographic revenues in accordance with guidance issued by the FASB. Our reportable segments are strategic business units that offer different products and services.

Results for each segment and consolidated results are as follows for the three-month periods ended May 31, 2020 and 2019 (in thousands, because of rounding numbers may not foot):

	Three months ended May 31, 2020
	Lancaster		Buffalo		North Carolina		Paris		Eliminations			Total
Net revenues	$	6,728	$	3,039	$	1,909	$	622	$	–		$	12,298
Income (loss) from operations		2,518		610		414		315		–			3,857
Total assets		57,145		10,730		14,288		19,424		(40,007	)		61,579
Capital expenditures		7		12		13		–		–			32
Capitalized software costs		494		4		32		76		–			606
Depreciation and amortization		430		88		151		119		–			788

	Three months ended May 31, 2019
	Lancaster		Buffalo		North Carolina		Paris		Eliminations			Total
Net revenues	$	6,025	$	2,538	$	1,374	$	–	$	–		$	9,937
Income (loss) from operations		3,044		387		451		–		–			3,882
Total assets		40,130		10,147		12,927		–		(17,702	)		45,502
Capital expenditures		31		8		3		–		–			42
Capitalized software costs		351		27		44		–		–			422
Depreciation and amortization		440		92		146		–		–			678

	Nine months ended May 31, 2020
	Lancaster		Buffalo		North Carolina		Paris		Eliminations			Total
Net revenues	$	17,559	$	8,176	$	5,692	$	622	$	–		$	32,049
Income (loss) from operations		6,425		926		1,735		315		–			9,401
Total assets		57,145		10,730		14,288		19,424		(40,007	)		61,579
Capital expenditures		24		53		29		–		–			106
Capitalized software costs		1,523		40		93		76		–			1,732
Depreciation and amortization		1,301		263		451		119		–			2,134

	Nine months ended May 31, 2019
	Lancaster		Buffalo		North Carolina		Paris		Eliminations			Total
Net revenues	$	15,398	$	6,895	$	3,652	$	–	$	–		$	25,945
Income (loss) from operations		6,614		1,093		992		–		–			8,699
Total assets		40,130		10,147		12,927		–		(17,702	)		45,502
Capital expenditures		34		25		16		–		–			75
Capitalized software costs		1,135		93		134		–		–			1,362
Depreciation and amortization		1,366		272		432		–		–			2,070

In addition, the Company allocates revenues to geographic areas based on the locations of its customers. Geographical revenues for the three months and nine months ended May 31, 2020 and 2019 were as follows (in thousands, because of rounding numbers may not foot):

Three months ended May 31, 2020
	North & South America		Europe		Asia		Total
Lancaster	$	3,401	$	1,719	$	1,608	$	6,728
Buffalo		3,039		–		–		3,039
North Carolina		1,685		130		94		1,909
Paris		537		85		–		622
Total	$	8,662	$	1,934	$	1,702	$	12,298

Three months ended May 31, 2019
	North & South America		Europe		Asia		Total
Lancaster	$	2,872	$	1,497	$	1,656	$	6,025
Buffalo		2,538		–		–		2,538
North Carolina		906		363		105		1,374
Total	$	6,316	$	1,860	$	1,761	$	9,937

Nine months ended May 31, 2020
	North & South America		Europe		Asia		Total
Lancaster	$	8,555	$	4,476	$	4,528	$	17,559
Buffalo		8,176		–		–		8,176
North Carolina		4,890		581		221		5,692
Paris		537		85		–		622
Total	$	22,158	$	5,142	$	4,749	$	32,049

Nine months ended May 31, 2019
	North & South America		Europe		Asia		Total
Lancaster	$	7,059	$	4,207	$	4,132	$	15,398
Buffalo		6,895		–		–		6,895
North Carolina		2,622		550		480		3,652
Total	$	16,576	$	4,757	$	4,612	$	25,945

NOTE 10: EMPLOYEE BENEFIT PLAN

We maintain a 401(K) Plan for all eligible employees, and we make matching contributions equal to 100% of the employee’s elective deferral, not to exceed 4% of total employee compensation. We can also elect to make a profit-sharing contribution. Our contributions to this Plan amounted to $123,549 and $116,839 for the three months ended May 31, 2020 and 2019, respectively and $325,220 and $295,777 for the nine months ended May 31, 2020 and 2019 respectively.

NOTE 11: ACQUISITION/MERGER WITH LIXOFT

On March 31, 2020, the Company entered into a Stock Purchase and Contribution Agreement (the “Agreement”) with Lixoft, a French société par actions simplifiée (“Lixoft”). On April 1 2020, the Company consummated the acquisition of all outstanding equity interests of Lixoft pursuant to the terms of the Agreement, with Lixoft becoming a wholly owned subsidiary of the Company. We believe the combination of Simulations Plus and Lixoft provides substantial future potential based on the complementary strengths of each of the companies.

Under the terms of the Agreement, as described below, the Company will pay the former shareholders of Lixoft total consideration of up to $16,500,000, consisting of two-thirds cash and one-third newly issued, unregistered shares of the Company’s common stock. In addition, the Company will pay $3,456,029 of excess working capital based on the March 31, 2020 financial statements of Lixoft.

On April 1, 2020, the Company paid the former shareholders of Lixoft a total of $10,789,362, comprised of cash in the amount of $9,460,129 and the issuance of 111,682 shares of the Company’s common stock valued at $3,662,337 (under the terms of the Agreement a price of approximately $32.15 dollars per share was used based upon the volume-weighted average closing price of the Company’s shares of common stock for the 30-consecutive-trading-day period ending two trading days prior to April 1, 2020). The actual stock price at April 1, 2020 was $34.92, so the total value of the stock issued was approximately $3,900,000, of which 9,669 shares are held in an escrow for offset for representations and warrantees. Within three business days following the two-year anniversary of March 31, 2020 (the date of the Agreement) and subject to any offsets for representations and warrantees, the Company will pay the former shareholders of Lixoft a total of $2,000,000, comprised of $1,333,333 of cash and the release from an escrow shares of stock valued at $666,337 issued at the date of the Agreement. The Agreement provides for a two-year market standoff period in which the newly issued shares may not be sold by the recipients thereof.

In addition, the agreement calls for earn-out payments up to an additional $5,500,000, two-thirds cash and one-third newly issued, unregistered shares of the Company’s common stock based on a revenue growth formula each year for the two years subsequent to April 1, 2020. The former shareholders can earn up to $2,000,000 the first year and $3,500,000 in year two. The Earn-out liability has been recorded at fair value.

Under the acquisition method of accounting, the total purchase price reflects Lixoft’s tangible and intangible assets and liabilities based on their estimated fair values at the date of the completion of the acquisition (April 1, 2020). The following table summarizes the preliminary allocation of the purchase price for Lixoft:

Assets acquired, Including cash of $3,799,134 and accounts receivable of $629,481	$	4,994,160
Developed Technologies Acquired		8,030,000
Estimated value of Intangibles assets acquired (Customer Lists, trade name etc.)		4,160,000
Estimated Goodwill acquired		2,404,973
Liabilities Assumed		(862,208	)
Total Consideration	$	18,726,925

Goodwill has been provided in the transaction based on estimates of future earnings of this subsidiary including anticipated synergies associated with the positioning of the combined company as a leader in model-based drug development.

Consolidated supplemental Pro Forma information

The following consolidated supplemental pro forma information assumes that the acquisition of Lixoft took place on September 1, 2018 for the income statement for the three-month and nine-month periods ended May 31, 2020. These amounts have been calculated after applying the Company’s accounting policies and adjusting the results of Lixoft to reflect the same expenses in the three-month period ended May 31, 2019. The adjustments include costs of acquisition, and amortization of intangibles and other technologies acquired during the merger, assuming the fair-value adjustments applied on September 1, 2018, together with consequential tax effects.

	For the three-month period ended				For the nine-month period ended
	May 31, (in 1000’s) (Unaudited)				May 31, (in 1000’s) (Unaudited)
	(Pro forma)*		(Pro forma)		(Pro forma)*		(Pro forma)
	2020		2019		2020		2019
Net Sales	$	12,422	$	10,520	$	34,430	$	28,389
Net Income	$	3,565	$	2,860	$	8,442	$	7,076

*Balances include two months actual results for Lixoft.

NOTE 12 - SUBSEQUENT EVENTS:

Dividend Declared

On July 7, 2020, our Board of Directors declared a quarterly cash dividend of $0.06 per share to our shareholders. The dividend will be distributed on Monday August 3, 2020, for shareholders of record as of Monday July 27, 2020.

Item 2. Management's Discussion and Analysis or Plan of Operations

Forward-Looking Statements

This document and the documents incorporated in this document by reference contain forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact contained in this document and the materials accompanying this document are forward-looking statements.

The forward-looking statements are based on the beliefs of our management, as well as assumptions made by and information currently available to our management. Frequently, but not always, forward-looking statements are identified by the use of the future tense and by words such as “believes,” expects,” “anticipates,” “intends,” “will,” “may,” “could,” “would,” “projects,” “continues,” “estimates” or similar expressions. Forward-looking statements are not guarantees of future performance and actual results could differ materially from those indicated by the forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by the forward-looking statements.

The forward-looking statements contained or incorporated by reference in this document are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”) and are subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. These statements include declarations regarding our plans, intentions, beliefs, or current expectations.

Among the important factors that could cause actual results to differ materially from those indicated by forward-looking statements are the risks and uncertainties described under “Risk Factors” in our Annual Report and elsewhere in this document and in our other filings with the SEC.

Forward-looking statements are expressly qualified in their entirety by this cautionary statement. The forward-looking statements included in this document are made as of the date of this document and we do not undertake any obligation to update forward-looking statements to reflect new information, subsequent events, or otherwise.

General

BUSINESS

OVERVIEW

Simulations Plus, Inc., incorporated in 1996, is a premier developer of drug discovery and development software for mechanistic modeling and simulation, and for machine-learning-based prediction of properties of molecules solely from their structure. Our pharmaceutical/chemistry software is licensed to major pharmaceutical, biotechnology, agrochemical, cosmetics, and food industry companies and to regulatory agencies worldwide for use in the conduct of industry-based research. We also provide consulting services ranging from early drug discovery through preclinical and clinical trial data analysis and for submissions to regulatory agencies. Simulations Plus is headquartered in Southern California, with offices in Buffalo, New York, and Research Triangle Park, North Carolina, and Paris, France. Its common stock trades on the Nasdaq Capital Market under the symbol “SLP.”

We are a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents and provide a wide range of early discovery, preclinical, and clinical consulting services and software. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, physiology, and machine learning into our software have made us the leading software provider for PBPK modeling and simulation, prediction of molecular properties from structure, and prediction of drugs to induce liver injury or to treat nonalcoholic fatty liver disease.

We generate revenue by delivering relevant, cost-effective software and creative and insightful consulting services. Pharmaceutical and biotechnology companies use our software programs and scientific consulting services to guide early drug discovery (molecule design and screening), preclinical, and clinical development programs. They also use our software products and services to enhance their understanding of the properties of potential new medicines and to use emerging data to improve formulations, select and justify dosing regimens, support the generics industry, optimize clinical trial designs, and simulate outcomes in special populations, such as the elderly and pediatric patients.

Simulations Plus acquired Cognigen Corporation (Cognigen) as a wholly owned subsidiary in September 2014. Cognigen was originally incorporated in 1992. Through the integration of Cognigen into Simulations Plus, Simulations Plus became a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. Our clinical-pharmacology-based consulting services include pharmacokinetic and pharmacodynamic modeling, clinical trial simulations, data programming, and technical writing services in support of regulatory submissions. We have also developed software for harnessing cloud-based computing in support of modeling and simulation activities and secure data archiving, and we provide consulting services to improve interdisciplinary collaborations and research and development productivity.

Simulation Plus acquired DILIsym Services, Inc. (DILIsym) as a wholly owned subsidiary in June 2017. The acquisition of DILIsym positions the Company as the leading provider of Drug Induced Liver Injury (DILI) modeling and simulation software and related scientific consulting services. In addition to the DILIsym® software for analysis of potential drug-induced liver injury, DILIsym Services, Inc. also has developed a simulation program for analyzing nonalcoholic fatty liver disease (NAFLD) called NAFLDsym™. Both the DILIsym and NAFLDsym software programs require outputs from physiologically based pharmacokinetics (PBPK) software as inputs. The GastroPlus™ PBPK software from Simulations Plus provides such information; thus, the integration of these technologies will provide a seamless capability for analyzing the potential for drug-induced liver injury for new drug compounds and for investigating the potential for new therapeutic agents to treat nonalcoholic fatty liver disease. Since the acquisition, DILIsym has applied its mechanistic modeling resources in other disease areas including idiopathic pulmonary fibrosis (IPF) and others.

Simulations Plus acquired Lixoft as a wholly owned subsidiary on April 1, 2020. Lixoft brings to Simulations Plus its powerful software products, Monolix, Simulx and PKanalix, which can take a modeling project from data exploration to clinical trial simulations. In addition, Lixoft provides training and focused consulting services which can accelerate a pharmacometric study. Lixoft’s technologies were developed as a result of a research program led by Inria, on non-linear mixed effect models for advanced population analysis, pharmacometrics, pre-clinical and clinical trial modeling and simulation.

PRODUCTS

General

We currently offer ten software products to support pharmaceutical, biotechnology, chemicals, cosmetics, and consumer goods research and development: five simulation programs that provide time-dependent results based on solving large sets of differential equations: GastroPlus®; DDDPlus™; MembranePlus™; DILIsym®; and NAFLDsym™; two programs that are based on predicting and analyzing static (not time-dependent) properties of molecules: ADMET Predictor® and MedChem Designer™; (the combination of ADMET Predictor, MedChem Designer, and MedChem Studio™ is called our ADMET Design Suite™); a program which is designed for rapid analysis and regulatory submissions of pharmacokinetic data called PKPlus™; a program called KIWI™ from our Cognigen division that provides an integrated platform for NONMEM® data analysis and reporting through our proprietary secure cloud; and, through our acquisition of Lixoft in March 2020, a platform focused on non-linear mixed effects modeling (NLME) for pharmacometrics called Monolix™.

GastroPlus®

Our flagship product, originally introduced in 1998, and currently our largest single source of software revenue, is GastroPlus. GastroPlus mechanistically simulates the absorption, pharmacokinetics, pharmacodynamics, and drug-drug interactions of compounds administered to humans and animals and is currently the most widely used commercial software of its type by industry, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health (NIH), and other government agencies in the U.S. and around the world.

Our goal with GastroPlus is to integrate the most advanced science into user-friendly software to enable researchers and regulators to perform sophisticated analyses of complex compound behaviors in humans and laboratory animals. Already the most widely used program in the world for PBBM/PBPK modeling, the addition of these new capabilities is expected to expand the user base in the early pharmaceutical research and development process, while also helping us to further penetrate biopharmaceuticals, food, cosmetics, and general toxicology markets. We work to release updated versions of the program on an ongoing basis. In June 2019, we released Version 9.7 of GastroPlus. This version adds several important new capabilities, including improvements to population simulations, dissolution, absorption, PBPK models, and drug-drug interactions, among others.

	·	The ability to add lysosomal trapping effect to PBPK tissues
	·	New mechanistic pregnancy PBPK model (with fetus compartment)
	·	Additional solubility inputs for different drug forms (crystalline, amorphous)
	·	New models of standard compounds (substrates/inhibitors/inducers) in DDI Module
	·	Expanded fed state conditions based on meal type
	·	New ability to allow different tissue model types (perfusion- or permeability-limited) between parent and metabolites or victim perpetrator in metabolite tracking/DDI simulations
	·	PK-PD model additions to PKPlus Module
	·	Updates to the dermal absorption (TCAT) model through Cosmetics Europe project
	·	New effect of immune response with intramuscular injection models
	·	Updated default populations for extensive, intermediate, and poor metabolizers based on specific genotypes

Because of the widespread use of GastroPlus, we have been able to enter into collaborations with industry and government agencies to drive advances to modeling and simulation science. In all, Simulations Plus owns the intellectual property developed within the GastroPlus program, and updates are integrated into future versions and made available to clients:

Ocular absorption model: in September 2014, we entered into a research collaboration agreement (RCA) with the FDA to enhance the Ocular Compartmental Absorption and Transit (OCAT™) model within the Additional Dosage Routes Module of GastroPlus. The objective of this agreement was to provide a tool for generic companies and the FDA to assess the likely bioequivalence of generic drug formulations dosed to the eye. After a successful second year, the RCA was extended for two additional years in September 2016, with primary tasks completed in September 2018. Additional functionality was further requested by the FDA, and a new funded contract was awarded for the 2018-19 period. In May 2020, we were awarded a new grant from the FDA to support interspecies translation for ocular drug delivery in GastroPlus.

Long-acting injectable (LAI) product models: in September 2015, we were awarded another RCA by the FDA to expand the capabilities of GastroPlus to simulate the dosing of long-acting injectable microspheres for both small and large molecules (biologics). Under this agreement, we developed simulation models to deal with the very slow dissolution/decomposition of the microsphere carrier material that gradually releases the active drug over periods as long as weeks or months. After a successful second year, the RCA was renewed for the third year in September 2017 and was completed in September 2018. In September 2019, we entered a new funded collaboration with a clinical-stage biotechnology company to develop an intra-articular (IA) delivery model, using much of the technology developed through the LAI collaboration with the FDA. This collaboration enhances the GastroPlus physiologically based biopharmaceutics (PBBM)/PBPK model for drug dosing into joints through IA injection products and incorporate a mechanistic model for different species and population groups that will allow for efficient evaluation of IA injection strategies.

Transdermal absorption model: in July 2018 we entered into a research collaboration with a large European consortium to further develop and validate the mechanistic Transdermal Compartmental Absorption and Transit (TCAT™) model in GastroPlus. This project contributes substantially to improvements in the program, specifically directed toward the predictions of local exposure within the skin layer following topical administration of various chemicals. In September 2018, we were awarded another funded RCA by the FDA to integrate drug product quality attributes into the mechanistic TCAT™ model in GastroPlus. This grant award focuses on the incorporation of drug product quality attributes into dermal physiologically based pharmacokinetic (PBPK) models developed for dermatological topical dosage forms and transdermal delivery systems.

Virtual bioequivalence trials: in October 2019, we entered a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator™ in GastroPlus. This collaboration will enhance the GastroPlus PBBM/PBPK platform to evaluate population and formulation variability on the BE of different products. We intend to improve virtual BE trial simulation methodologies and efficiently address regulatory concerns as model results are reviewed.

Oral absorption (ACAT™) model: in November 2019, we entered a new funded collaboration with a large pharmaceutical company to modify the mechanistic oral absorption (ACAT™) model in GastroPlus to support gastrointestinal disease research. This collaboration will enhance and advance understanding of local drug disposition in the gut tissue and improve the accuracy of drug concentration predictions to assist with the development of new therapies for gastrointestinal diseases.

Unfunded research collaborations: in addition to the active funded efforts with the FDA described above, we also have two unfunded RCAs with the FDA: one with the Office of Generic Drugs (OGD) that began in 2014, and one announced in July 2019 with the Center for Veterinary Medicine (CVM). With OGD, the objective is directed toward the FDA’s evaluation of mechanistic IVIVCs (in vitro-in vivo correlations) to determine whether mechanistic absorption modeling (MAM) can relate laboratory (in vitro) dissolution experiment results to the behavior of dosage forms in humans and animals (in vivo) better than traditional empirical methods. With CVM, the objective is to use GastroPlus, with in vitro and in vivo data, to investigate how bioequivalence (BE) of non-systemically absorbed products can be evaluated in canines without the need for clinical endpoint trials.

DDDPlus™

DDDPlus mechanistically simulates in vitro (laboratory) experiments that measure the rate of dissolution of a drug as well as, if desired, the additives (excipients) in a particular dosage form (e.g., powder, tablet, capsule, or injectable solids) under a variety of experimental conditions. This unique software program is used by formulation scientists in industry and the FDA to (1) understand the physical mechanisms affecting the disintegration and dissolution rates of various formulations, (2) reduce the number of cut-and-try attempts to design new drug formulations, (3) design in vitro dissolution experiments to better mimic in vivo (animal and human) conditions, and (4) justify product specifications. Version 6.0 of DDDPlus was released in January 2019 and offers a series of new capabilities, including:

	·	simulation of the in vitro dissolution of long-acting injectable dosage forms (funded by the FDA grant supporting GastroPlus development)
	·	simulation of the in vitro dissolution of controlled release bead formulations
	·	new simulation of artificial stomach-duodenum (ASD) experiments
	·	ability to fit models from precipitation experiments
	·	new dissolution apparatus models
	·	improved output reporting

MembranePlus™

Like DDDPlus, MembranePlus mechanistically simulates laboratory experiments, but in this case, the experiments are for measuring permeability or clearance of drug-like molecules through various membranes, including several different standard cell cultures (Caco-2, MDCK), as well as hepatocytes. The value of such simulations derives from the fact that when the same molecules are measured in different laboratories using (supposedly) the same experimental conditions, the results are often significantly different. These differences are caused by a complex interplay of factors in how the experiment was set up and run. MembranePlus simulates these experiments with their specific experimental details, and this enables scientists to better interpret how results from specific experimental protocols can be used to predict permeability or clearance mechanisms in human and animals.

PKPlus™

The standalone PKPlus program, based on the internal PKPlus Module in GastroPlus that has been available since 2000, provides the full level of functionality needed by pharmaceutical industry scientists to perform the analyses and generate the outputs needed to fully satisfy regulatory agency requirements for NCA as well as providing limited support for compartmental PK modeling.

PKPlus version 2.5 was released in July 2019. This new version incorporates a wide variety of requested features from current users, including:

Import CDISC SEND packages with PC domain as source data

Improved command line functionality

64-bit system optimization for improved performance

Streamlined auto-reports

Additional workflow refinements

In November 2019, we entered a new funded collaboration with a large pharmaceutical company to enhance the PKPlus software. Following a rigorous evaluation of multiple commercial offerings, our partner selected PKPlus as the pharmacokinetics/toxicokinetic (PK/TK) modeling program to support the internal data platform that connects their global teams. Our objectives for this project will be to design the next-generation engine that automates the import and mapping of data, selection of calculation templates, and generation of reports within a streamlined, validated system.

ADMET Predictor®

ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) Predictor is a top-ranked, chemistry-based computer program that takes molecular structures (i.e., drawings of molecules represented in various formats) as inputs and uses machine learning technology to predict approximately 150 different properties for them at an average rate of over 200,000 compounds per hour on a modern laptop computer. This capability allows chemists to generate estimates for a large number of important molecular properties without the need to synthesize and test the molecules, as well as to generate estimates of unknown properties for molecules that have been synthesized, but for which only a limited number of experimental properties have been measured. Thus, a chemist can assess the likely success of a large number of existing molecules in a company’s chemical library, as well as molecules that have never been made, by providing only their molecular structures, either by drawing them using a tool such as our MedChem Designer software, or by automatically generating large numbers of molecules using various computer algorithms, including those embedded in our MedChem Studio™ Module.

The optional ADMET Modeler™ Module in ADMET Predictor enables scientists to use their own experimental data to quickly create proprietary high-quality predictive models using the same powerful artificial intelligence (AI) engine we use to build our top-ranked property predictions.

Version 9.5 of ADMET Predictor was released in April 2019, adding:

	·	Novel approaches to calculate uncertainty estimates on all regression models
	·	New machine learning models for important metabolism and transporter endpoints
	·	New machine learning models for AMES mutagenicity, a primary toxicity endpoint required during risk assessment
	·	New Structure Sensitivity Analysis visualization tool to easily map atom-level contributions to model predictions
	·	Improved rat-specific models to more accurately inform HTPK Simulation predictions
	·	Improved Pipeline Pilot and KNIME components to extend deployment options and enterprise support for ADMET Predictor
	·	Updates to output displays in MedChem Designer™

We have made significant investments in two key areas with recent versions: improving integration of our top-ranked ADMET Predictor and GastroPlus models to leverage our novel ‘Discovery PBPK’ approaches for chemists and safety researchers, and further enhancing our best-in-class machine learning engine to assist with drug discovery. Recent publications from pharmaceutical and chemical companies describing how they have leveraged our ‘Discovery PBPK’ methods to guide lead optimization and risk assessment illustrate how our unique offerings provide substantial value in these spaces.

Drug discovery workflows: in December 2019, we entered into a new collaboration agreement with Bayer AG to advance our ADMET Predictor machine learning software for use within integrated drug discovery workflows by developing improved structure and tautomer handling capabilities that will support data integrity across the different discovery platforms.

High-throughput pharmacokinetic (HTPK) simulations: in April 2020, we entered into a new collaboration agreement with a large pharmaceutical company to develop enhanced capabilities in our existing HTPK Simulation Module which will incorporate PBPK modeling into the partner’s discovery platform to support compound screening activities.

Potential new markets for artificial intelligence (machine learning)

We are currently investigating applications of our sophisticated artificial intelligence (machine-learning) engine.

We believe our proprietary AI/machine learning software engine has a wide variety of potential applications and we intend to pursue funding to develop customized tools to further monetize our investment in this technology by expanding our markets beyond the life sciences and chemistry. In addition, we are examining a variety of expanded capabilities to add to the basic modeling engine to accommodate even larger data sets (“big data analytics”) and new applications.

MedChem Designer™

MedChem Designer was initially a molecule-drawing program, or “sketcher”, but now has capabilities far exceeding those of other molecule-drawing programs because of its integration with ADMET Predictor. We provide MedChem Designer for free because we believe that in the long run it will help to increase demand for ADMET Predictor. Over 33,000 copies of MedChem Designer have been downloaded by scientists around the world to date. Our free version includes a small set of ADMET Predictor’s best-in-class property predictions, allowing the chemist to modify molecular structures and then see a few key properties very quickly. When used with a license for ADMET Predictor, MedChem Designer becomes a de novo molecule design tool. With it, a researcher can draw one or more molecular structures, then click on the ADMET Predictor icon and have approximately 150 properties for each structure calculated in seconds, including our proprietary ADMET Risk™ index which provides a single number that instantly compare the effects of different structural changes in many dimensions. Researchers can also click on an icon to generate the likely metabolites of a molecule and then predict all the properties of those metabolites from ADMET Predictor, including each of their ADMET Risk scores.

KIWI™

Drug development programs rely increasingly on modeling and simulation analyses to support decision-making and submissions to regulatory agencies. To ensure high-quality reliable analyses, organizations must not only apply high-quality science, but must also be able to support the science with validated and reproducible results.

KIWI is a cloud-based web application that provides scientists with a secure, validated, enterprise-scale environment wherein they can efficiently organize, process, maintain, and communicate the volume of data and results generated over the duration of a drug development program. KIWI enables global teams to collaborate on model-based decision-making and has been proven to support and encourage interdisciplinary discussions about the model development process and the interpretation of results.

In addition to providing a structured workflow for model-based analyses, key features of the application include powerful visualization tools to support exploratory analyses, a data repository to facilitate management and organization of data and documents, and a Model Wizard module to streamline coding and model development.

New versions of KIWI are released on a regular basis. KIWI Version 2 was released in December 2017, KIWI 3 was released in August 2018, and KIWI 4 was released in June 2019. In fiscal year 2020 to date, we have:

further improved the visualization tools,

introduced kiwiConnect, an R-based API to improve interaction and interconnectivity between R and KIWI, and

completed a major update to the Oracle database infrastructure, including new hardware, additional storage, and increased bandwidth.

We remain focused on further enhancing KIWI as part of our five-year, almost-$5 million contract with the Bill and Melinda Gates Foundation.

DILIsym

The DILIsym software is a quantitative systems pharmacology (QSP) program that has been in development since 2011. QSP software models are based on the fundamental understanding of complex biological pathways, disease processes, and drug mechanisms of action, integrating information from experiments and forming hypotheses for the next experimental model. DILIsym deals with the propensity for some drug molecules to induce temporary or permanent changes in biological functions within liver cells (hepatocytes) that can result in damage to the liver (i.e. drug-induced liver injury or DILI).

Version 8A of the DILIsym software was released in January of 2019. This version was delivered as a secure executable that incorporates new proprietary code enabling tighter integration with our GastroPlus PBPK software. A number of important new capabilities were added, including new exemplar compounds, new biomarkers, and new mechanisms of DILI. DILIsym version X is expected to be released in later Summer or early Fall of 2020. DILIsym X will be completely refactored into a much faster and more user friendly software tool.

NAFLDsym

Where DILIsym is used to investigate the likelihood that a known drug molecule would cause injury to the liver, NAFLDsym is concerned with a liver that is already diseased (NAFLD/NASH) by excess fat, fibrosis, and inflammation, and investigates the likelihood that various molecules might provide beneficial therapeutic benefits to treat or cure the disease. DILIsym can be considered a “shrink wrap” software product, usable across many companies and drug development projects. NAFLDsym, on the other hand, requires modification for each of a number of different mechanisms of action that potential new drug compounds could use to treat the disease, and so is a customized tool used in consulting projects for each new client project. NAFLDsym version 2A was released in the summer of 2019 for licensing and consulting use. The software now includes the three most important components of NAFLD/NASH: steatosis, inflammation, and fibrosis, along with a host of other important updates.

RENAsym

RENAsym will be focused on investigating and predicting drug-induced kidney injury, or acute kidney injury (AKI). RENAsym will be another “shrink wrap” software product, usable across many companies and drug development projects. The software will utilize predictions of drug exposure in the kidney from PBPK platforms such as GastroPlus, along with in vitro data related to certain kidney injury mechanisms, to make predictions. The first expected release of RENAsym will be available in summer of 2021. The initial development is being funded via an NIH small business grant.

IPFsym

IPFsym is a software tool that will investigate the likelihood that various molecules might provide beneficial therapeutic benefits to treat or cure idiopathic pulmonary fibrosis (IPF). IPFsym, like NAFLDsym, requires modification for each of a number of different mechanisms of action that potential new drug compounds could use to treat the disease, and so is a customized tool used in consulting projects for each new client project. IPFsym is targeted for release for licensing and consulting use in late 2020. The software will include the most important mechanisms of IPF and will be closely coupled with GastroPlus for drug concentration predictions within the lungs.

Monolix Suite

The Monolix Suite is a unique solution for modeling and simulation for pharmaceutical companies, biotechs, and hospitals. It allows nonparametric analyses, population PKPD analyses and modeling and clinical trial simulation. The extended MonolixSuite contains three main products: Monolix, Simulx, and PKanalix. These products are interconnected and interoperable, i.e. the user can go from one application to another one without changing anything in terms of data set or of biological models.

The products are used by many pharmaceutical companies across the globe at each step of the drug development, from preclinical, first-in-human, clinical and post approval. These products are well established in the community and have been accepted by many of the main regulatory agencies.

Lixoft's technologies come from an eight-year research program in modeling and biostatistics led by Inria and sponsored by the pharmaceutical industry. The extended MonolixSuite was developed in view of the increasing importance of pharmacometrics experts in drug development, taking a modeling project from the first data exploration up to clinical trial simulations.

Monolix

Monolix (Non-linear mixed-effects models or “MOdèles NOn LInéaires à effets miXtes” in French) is a platform of reference for model-based drug development. It combines the most advanced algorithms with unique ease of use. Pharmacometricians of preclinical and clinical groups can rely on Monolix for population analysis and to model PK/PD and other complex biochemical and physiological processes. Monolix is an easy, fast and powerful tool for parameter estimation in non-linear mixed effect models, model diagnosis and assessment, and advanced graphical representation.

Simulx

Simulx is a powerful and flexible simulator for clinical trial pharmacometrics that runs on top of the Lixoft simulation engine. It allows to simulate any type of model output (continuous, event, categorical…). It directly connects with Monolix for seamless Modeling and Simulation, or can be used as a standalone application to simulate a new model. The overview of possibilities includes comparison of different trial designs, extrapolation to different populations, non-adherence to treatment, optimal dosing, and dose individualization after therapeutic drug monitoring.

Simulx is currently available via the comprehensive R package mlxR. Starting with the 2020 version, it will have a user interface to easily define groups of simulations as well as simulation outcomes to compare.

PKanalix

PKanalix performs analysis on PK data sets. Several analyses are performed including:

	·	the non-compartmental analysis (NCA),
	·	the compartmental analysis (CA) consisting in finding parameters of a model representing the PK as the dynamics in compartments for each individual. Notice that this compartment analysis does not include population analysis that could be performed in Monolix.

PKanalix provides a clear user-interface with a simple workflow to perform NCA and CA analysis in an efficient way.

Contract Research and Consulting Services

Our scientists and engineers have expertise in drug absorption via various dosing routes (oral, intravenous, subcutaneous, intramuscular, ocular, nasal/pulmonary, and dermal), pharmacokinetics, pharmacodynamics, and drug-drug interactions, and we conduct contracted consulting studies for customers (including many of the top twenty pharmaceutical companies) who have particularly difficult problems and who recognize how our expertise & technology can help solve them. The demand for our consulting services has been steadily increasing, and we have expanded our consulting teams to meet the increased workload.

We have a reputation for high-quality analyses and regulatory reporting of data collected during preclinical experiments as well as clinical trials of new and existing pharmaceutical products, typically working on 80-100 projects per year. Traditionally, the model-based analysis of clinical trial data was different from the modeling analysis offered by GastroPlus or our quantitative systems toxicology/pharmacology software (DILIsym and NAFLDsym); the former relied more on statistical and semi-mechanistic models, whereas the latter is based on very detailed mechanistic models. Statistical models rely on direct observation and mathematical equations that are used to fit data collected across multiple studies along with describing the variability within and between patients. Mechanistic models are based on a detailed understanding of the human body and the chemistry of the drug and involve deep mathematical and scientific representation of the phenomena involved in drug dissolution/precipitation, absorption, distribution, metabolism, and elimination. Collectively, the models support safety and efficacy decisions, first-in-human estimations, formulation optimization, and drug-drug interaction assessments. Beginning in 2014, the U.S. FDA and other regulatory agencies began to emphasize the need to push mechanistic PBPK modeling and simulation into clinical pharmacology, with final guidance documents completed in 2018, and we have seen the benefit of having our clinical pharmacology teams across all three divisions working together to achieve this goal. To date, there have been approximately 40 approved drug products on the market today whose submissions were informed by results from GastroPlus.

PRODUCT DEVELOPMENT

Development of our software is focused on expanding product lines, designing enhancements to our core technologies, and integrating existing and new products into our principal software architecture and platform technologies. We intend to continue to offer regular updates to our products and to continue to look for opportunities to expand our existing suite of products and services.

To date, we have developed products internally, sometimes also licensing or acquiring products, or portions of products, from third parties. These arrangements sometimes require that we pay royalties to third parties. We intend to continue to license or otherwise acquire technology or products from third parties when it makes business sense to do so.

In 1997 we entered into an exclusive software licensing agreement with TSRL, Inc. (Therapeutic Systems Research Laboratories) pursuant to which TSRL licensed certain software technology and databases to us, and we paid royalties to TSRL. On May 15, 2014, we and TSRL entered into a termination and nonassertion agreement pursuant to which the parties agreed to terminate the 1997 exclusive software licensing agreement. As a result, the Company obtained a perpetual right to use certain source code and data, and TSRL relinquished any rights and claims to any GastroPlus products and to any claims to royalties or other payments under that agreement, and we agreed to pay TSRL total consideration of $6,000,000. All payments were made as of April 2017. The total consideration is being amortized at a constant rate of $150,000 per quarter until it is completely amortized, after which no further expense will be incurred. To date, this has resulted in expense savings over $2,300,000 compared to the royalty payments that would have been paid to TSRL if paid consistent with past practices.

MARKETING AND DISTRIBUTION

We distribute our products and offer our services in North America, South America, Europe, Japan, Australia, New Zealand, India, Singapore, Taiwan, Korea, and the People’s Republic of China.

We market our pharmaceutical software and consulting services through attendance and presentations at scientific meetings, exhibits at trade shows, seminars at pharmaceutical companies and government agencies, through our website, and using various communication channels to our database of prospects and customers. At various scientific meetings around the world each year there are numerous presentations and posters presented in which the reported research was performed using our software. Many of these presentations are from industry and FDA scientists; some are from our staff. In addition, more than 100 peer-reviewed scientific journal articles, posters, and podium presentations are typically published each year using our software, mostly by our customers, further supporting its use in a wide range of preclinical and clinical studies.

Our sales and marketing efforts are handled primarily internally by sales and marketing staff and with our scientific team and several senior management staff assisting our marketing and sales staff with trade shows, seminars, and customer trainings both online and on-site. We also have independent distributors in Japan, China, India, and Korea who also sell and market our products with support from our scientists and engineers.

We provide support to the GastroPlus User Group in Japan, which was organized by Japanese researchers in 2009. In early 2013, a group of scientists in Europe and North America organized another GastroPlus User Group following the example set in Japan. Over 1,000 members have joined this group to date. We support this group through coordination of online meetings each month and managing the user group web site for exchange of information among members. These user groups provide us valuable feedback with respect to desired new features and suggested interface changes.

PRODUCTION

Our pharmaceutical software products are designed and developed by our development teams in California, North Carolina (Research Triangle Park), New York (Buffalo), and Paris, France we also employee people who are able to work remotely using collaboration software. Our products and services are now delivered electronically – we no longer provide CD-ROMs and printed manuals or reports.

COMPETITION

In our pharmaceutical software and services business, we compete against a number of established companies that provide screening, testing and research services, and products that are not based on simulation software. There are also software companies whose products do not compete directly with, but are sometimes closely related to, ours. Our competitors in this field include some companies with financial, personnel, research, and marketing resources that are larger than ours. Our flagship product, GastroPlus, is the most widely used commercial PBPK modeling platform and has one significant competitor; others could be developed over time, but with the high barrier to entry, it would be difficult to validate new software to levels required to support regulatory submissions. Our PKPlus software product competes with one major and a few minor software programs. MedChem Studio, MedChem Designer, and ADMET Predictor/ADMET Modeler operate in a more competitive environment. Several other companies presently offer simulation or modeling software, or simulation-software-based services, to the pharmaceutical industry. Lixoft’s Momolix Suite competes with a few established software products offered within the pharmaceutical software industry. We believe DILIsym and NAFLDsym enjoy a unique market position, with no significant competition.

Major pharmaceutical companies conduct drug discovery and development efforts through their internal development staffs and through outsourcing. Smaller companies generally need to outsource a greater percentage of this research. Thus, we compete not only with other software suppliers and scientific consulting service providers, but also with the in-house development and scientific consulting teams at some of the larger pharmaceutical companies.

Although competitive products exist, both new licenses and license renewals for GastroPlus have continued to grow. We believe that we enjoy a dominant market share in this segment. We believe our ADMET Predictor/ADMET Modeler, MedChem Studio, MedChem Designer, DDDPlus, MembranePlus, PKPlus, KIWI, DILIsym, NAFLDsym and Monolix Suite of software offerings are each unique in their combination of capabilities and remain a focus of our marketing strategy.

Based on our technical knowledge and expertise, the Company is strategically placed to offer modeling and simulation consulting services to companies. Our clients seek out our services for multiple reasons: (1) to acquire scientific, therapeutic area related or modeling expertise that they do not have in-house, (2) to address an excess of modeling and simulation requirements beyond the capacity of in-house resources, (3) to fulfill their modeling requirements more efficiently than they could do in-house, and (4) to utilize our software when they do not have the in-house expertise to do so. We apply our software and assist companies in such areas as: physiologically based pharmacokinetic modeling (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) data analysis; and quantitative systems pharmacology/toxicology (QSP/T). We compete against numerous service providers, ranging from departments within large contract research organizations (CROs) to independent consulting organizations of various sizes as well as individual consultants.

We believe the key factors in our ability to successfully compete in this field are our ability to: (1) continue to invest in research and development, and develop and support industry-leading simulation and modeling software and related products and services,(2) develop and maintain a proprietary database of results of physical experiments that serve as a basis for simulated studies and empirical models, (3) continue to attract and retain a highly skilled scientific and engineering team, (4) aggressively promote our products and services to our global market, and (5) develop and maintain relationships with research and development departments of pharmaceutical companies, universities, and government agencies.

In addition, we actively seek strategic acquisitions to expand both our pharmaceutical software and services business.

Results of Operations

Comparison of Three Months Ended May 31, 2020 and 2019.

The following table sets forth our condensed statements of operations (in thousands) and the percentages that such items bear to net sales (because of rounding, numbers may not foot):

	Three Months Ended
		5/31/20				5/31/19
Net revenues	$	12,298		100.0%		$	9,937		100.0%
Cost of revenues		2,665		21.7			2,324		23.4
Gross profit		9,633		78.3			7,613		76.6
Selling, general and administrative		5,023		40.8			3,087		31.1
Research and development		753		6.1			643		6.5
Total operating expenses		5,776		47.0			3,731		37.5
Income from operations		3,857		31.4			3,882		39.1
Other income (expense)		(77	)	(0.6	)		(29	)	(0.3	)
Income from operations before taxes		3,780		30.7			3,852		38.8
Provision for income taxes		(844	)	(6.9	)		(964	)	(9.7	)
Net income	$	2,936		23.9%		$	2,889		29.1%

Net Revenues

Consolidated net revenues increased by 23.8% or $2.36 million to $12.30 million in the third fiscal quarter of Fiscal Year 2020 (“3QFY20”) from $9.94 million in the third fiscal quarter of Fiscal Year 2019 (“3QFY19”). Changes by division are as follows:

Lancaster: $703,000 increase, representing a 11.7% increase to $6.73 million

Buffalo (Cognigen): $501,000 increase, representing a 19.7% increase to $3.04 million

North Carolina (DILIsym): $535,000 increase, representing a 38.9% increase to $1.91 million

Paris (Lixoft): Revenue for April and May 2020 totaled $622k and represented 5% of consolidated revenue for 3QFY20.

Consolidated software and software-related sales increased $1.03 million or 17.65% over 3QFY19. Lixoft’s software sales accounted for $566k or 55.1% of this increase. Consolidated consulting and analytical study revenues increased $1.33 million or 32.4% over 3QFY19.

Cost of Revenues

Consolidated cost of revenues increased by $341,000, or 14.7%, in 3QFY20 to $2.67 million from $2.32 million in 3QFY19. Labor-related cost including subcontractor payments increased by $402,000 quarter over quarter, a combination of increased labor count, and salary increases. Direct expenses on contracts increased by $193,000 this fiscal quarter compared to the prior year but were offset by a decrease of $154,000 in travel and training expense. Royalty expense was $189,000 lower in the period due to the effect of the final determination and termination of the royalty agreement for the Metabolism Module. Amortization expense related to Lixoft’s developed technologies resulted in an increase in amortization of $84,000 in 3QFY20.

Cost of Revenues as a percentage of revenues decreased slightly by 1.7% in 3QFY20 to 21.7% as compared to 23.4% in 3QFY19.

Gross Profit

Consolidated gross margin increased $2.02 million or 26.5%, to $9.63 million in 3QFY20 from $7.61 million in 3QFY19. The Lancaster division’s gross margin increased $914,000 or 17.5%, resulting in a 91.2% gross margin percentage. The Buffalo division’s gross margin increased $374,000 or 28.1%, resulting in a gross margin percentage of 56.2%. DILIsym of North Carolina showed an increase in gross margin of $203,000 or 19.1%, resulting in a gross margin of 66.1%. Lixoft’s gross margin equaled $529,000 and accounted for 26.2% of the increase in consolidated gross margin.

Overall gross margin as a percentage of revenue increased by 1.7% to 78.3% in 3QFY20 from 76.6% in 3QFY19.

Selling, General and Administrative Expenses

Selling, general, and administrative (SG&A) expenses increased $1.94 million, or 62.7% to $5.02 million in 3QFY20 from $3.09 million in 3QFY19. As a percent of revenues, SG&A was 40.8% for 3QFY20, compared to 31.1% in 3QFY19.

The major increases in SG&A expense were:

o	Selling expenses, including commissions and advertising, increased $76,000.
o	Legal and consulting fees increased $1.04 million due to services related to the acquisition of Lixoft.
o	G&A Salaries and Wages increased by $468,000; this increase is a combination of increased stock compensation costs, annual salary increases, and increased head count.
o	Payroll tax increased $160,000 due to an increase in headcount.
o	Vacation expense increased $127,000 due to increased headcount and increased vacation accruals as a result of COVID19 limitations on travel; employees were able to work from home and appear to not have followed normal vacation schedules.
o	Contract Labor increased $105,000 related to outsourced services and Director compensation.
o	Insurance Expense increased $140,000; mostly health-related medical costs due to cost increases and higher employee counts.

The major decreases in SG&A expense were:

o	Trade show costs and related travel expenses decreased $136,000.
o	Recruitment and hiring costs decreased $46,000.

Research and Development

Total research and development cost increased $293,000 in 3QFY20 compared to 3QFY19. In 3QFY20 we incurred approximately $1,359,000 of research and development costs, of this amount, $606,000 was capitalized and $753,000 was expensed. In 3QFY19 we incurred approximately $1,066,000 of research and development costs, of this amount, $422,000 was capitalized and $643,000 was expensed.

Income from operations

Income from operations decreased $25,000 or 0.7% in 3QFY20 compared to 3QFY19.

·	Lancaster	Decreased $526,000 or 17.3%
·	Buffalo	Increased $223,000 or 57.7%
·	No. Carolina	Decreased $38,000 or 8.3%
·	Paris	Lixoft’s income from operations equaled $316,000 and represents 8.2% of this quarter’s consolidated income from operations, this for the two months since acquisition (April 1, 2020 to May 31, 2020)

Provision for Income Taxes

The provision for income taxes was an expense of $844,000 for the 3QFY20 compared to a tax expense of $964,000 for the 3QFY19.

The effective rate for the three months was an expense of 22.3% compared to 25.0% in the prior year. The rate differs from statutory rates mainly due to stock compensation costs recognized for tax purposes in 3QFY20.

Net Income

Net income increased by $47,000, or 1.6%, in 3QFY20 to $2.94 million from $2.89 million in 3QFY19.

Comparison of Nine Months Ended May 31, 2020 and 2019

The following table sets forth our condensed statements of operations (in thousands) and the percentages that such items bear to net sales (because of rounding, numbers may not foot):

	Nine Months Ended
		5/31/20				5/31/19
Net revenues	$	32,049		100.00%		$	25,944		100.00%
Cost of revenues		7,975		24.9			6,735		26.0
Gross profit		24,074		75.1			19,209		74.0
Selling, general and administrative		12,646		39.5			8,614		33.2
Research and development		2,027		6.3			1,897		7.3
Total operating expenses		14,673		45.8			10,511		40.5
Income from operations		9,401		29.3			8,699		33.5
Other income (Expense)		(52	)	(0.16	)		(129	)	(0.5	)
Income from operations before taxes		9,349		29.2			8,570		33.0
Provision for income taxes		(2,205	)	(6.9	)		(2,046	)	(7.9	)
Net income	$	7,144		22.3%		$	6,524		25.1%

Net Revenues

Consolidated net revenues increased by $6.10 million or 23.5% to $32.05 million in the first nine months of Fiscal Year 2020 “9moFY20”) from $25.94 million in the first nine months of Fiscal Year 2019 (“9moFY19”). Changes by division are as follows:

·	Lancaster: $2,161,000 increase, representing a 14.0% increase to $17.56 million

·	Buffalo (Cognigen): $1,281,000 increase, representing a 18.6% increase to $8.18 million

·	North Carolina (DILIsym): $2,041,000 increase, representing an 55.9% increase to $5.69 million

·	Paris (Lixoft): Revenue for April and May 2020 totaled $622k

Consolidated software and software-related sales increased $2.19 million or 14.9%, with Lixoft’s software sales representing $566,000 or 25.9% of the consolidated increase. Consolidated consulting and analytical study revenues increased $3.91 million or 34.7% over 9moFY19.

Cost of Revenues

Consolidated cost of revenues increased by $1,240,000, or 18.4%, in 9moFY20 to $7.97 million from $6.73 million in 9moFY19. Labor-related costs accounted for $1,221,000 of this increase. Other significant increases in cost of revenues included $345,000 of direct contract costs. Royalty expense decreased by approximately $169,000 due to the termination of the royalty agreement for the Metabolism Module. In addition, travel expenses decreased by $166,000 during 9moFY20.

Cost of Revenues as a percentage of revenue decreased by 1.08% in 9moFY20 to 24.9% as compared to 26.0% in 9moFY19.

Gross Profit

Consolidated gross margin increased $4.86 million or 25.3%, to $24.07 million in 9moFY20 from $19.21 million in 9moFY19. The Lancaster division’s gross margin increased $2.44 million or 18.9%, resulting in a gross margin percentage of 87.6%. The Buffalo division’s gross margin increased $567,000 or 15.5%, resulting in a gross margin percentage of 51.8%, and DILIsym of North Carolina showed an increase in gross margin of $1.32 million or 50.5%, resulting in a 69.2% gross margin percentage. Lixoft’s gross margin equaled $529,000 and represented 10.9% of the increase in consolidated gross margin.

Overall gross margin as a percentage of revenue increased by 1.1% to 75.1% in 9moFY20 from 74.0% in 9moFY19.

Selling, General and Administrative Expenses

Selling, general, and administrative (SG&A) expenses increased $4.03 million, or 46.8% to $12.65 million in 9moFY20 from $8.61 million in 9moFY19. As a percent of revenues, SG&A was 39.4% for 9moFY20, compared to 33.2% in 9moFY19.

The major increases in SG&A expense were:

o	Commissions expense: $160,000 representing a combination of commissions to distributors and to commissioned salespersons
o	Contract labor: $184,000 comprised of outsourced services and increased Director compensation program costs
o	Legal and consulting: $1.42 million related to the acquisition of Lixoft.
o	G&A Salaries and Wages increased by $1.14 million; this increase is predominantly a result of increased head count and salaries in Lancaster and Buffalo, and the related bonus and stock compensation costs.
o	Insurance expense $364,000; mostly health-related medical costs due to cost increases and higher employee counts
o	Payroll tax expense increased $315,000 for domestic and international employees
o	Vacation expense: $193,000 increase due to headcount and increased vacation accruals as a result of COVID19 limitations on travel; employees were able to work from home and appear to not have followed normal vacation schedules.

The major decreases in SG&A expense were:

o	Trade show costs and related travel expenses decreased $58,000

Research and Development

Total research and development cost increased $501,000 in 9moFY20 compared to 9moFY19. In 9moFY20 we incurred approximately $3,760,000 of research and development costs, of this amount, $1,733,000 was capitalized and $2,027,000 was expensed. In 9moFY19 we incurred approximately $3,259,000 of research and development costs, of this amount, $1,362,000 was capitalized and $1,896,000 was expensed.

Income from operations

Income from operations increased $702,000 or 8.1% in 9moFY20 compared to 9moFY19.

·	Lancaster	Decreased $189,000 or 2.9%
·	Buffalo	Decreased $167,000 or 15.3%
·	No. Carolina	Increased $744,000 or 75%
·	Paris	Lixoft’s income from operations equaled $315,000 and represents 44.8% of the increase in consolidated income from operations, this for the two months since acquisition (April 1, 2020 to May 31, 2020)

Other income (expense)

Other income(expense) was an expense of $52,000 compared to expense of $129,000 in 9moFY19. Current year includes $81,000 of change in the value of contingent consideration for the two months since acquisition of Lixoft.

Provision for Income Taxes

The provision for income taxes was an expense of $2.21 million for the 9moFY20 compared to an expense of $2.05 million for 9moFY19. The effective rate for the nine months was an expense of 23.6% compared to a expense of 23.9% in the prior year.

Net Income

Net income increased by $620,000, or 9.5%, in 9moFY20 to $7.14 million from $6.52 million in 9moFY19.

Liquidity and Capital Resources

Our principal sources of capital have been cash flows from our operations. We have achieved continuous positive operating cash flow over the last ten fiscal years. We believe that our existing capital and anticipated funds from operations will be sufficient to meet our anticipated cash needs for working capital and capital expenditures for the foreseeable future. Thereafter, if cash generated from operations is insufficient to satisfy our capital requirements, we may draw from our revolving line of credit with the bank, or we may have to sell additional equity or debt securities or obtain expanded credit facilities. In the event such financing is needed in the future, there can be no assurance that such financing will be available to us, or, if available, that it will be in amounts and on terms acceptable to us. If cash flows from operations became insufficient to continue operations at the current level, and if no additional financing was obtained, then management would restructure the Company in a way to preserve its pharmaceutical business while maintaining expenses within operating cash flows.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

As of May 31, 2020 and August 31, 2019, we had cash and cash equivalents of $7.35 million and $11.40 million, respectively. We do not hold any investments that are exposed to market risk due to changes in interest rates, which could adversely affect the value of our assets and liabilities. In addition, we do not hold any instruments for trading purposes and investment. Some of our cash and cash equivalents are held in money market accounts; however, they are not exposed to market rate risk.

In the three and nine months ended May 31, 2020 and 2019, we sold $1,453,000 and $1,402,000 and $3,273,000 and $3,800,000, respectively, of software through representatives in certain Asian markets in local currencies. As a result, our financial position, results of operations, and cash flows can be affected by fluctuations in foreign currency exchange rates, particularly fluctuations in the yen and RMB exchange rates. These transactions give rise to receivables that are denominated in currencies other than the entity’s functional currency. The value of these receivables are subject to changes because the receivables may become worth more or less due to changes in currency exchange rates. The majority of our software license agreements are denominated in U.S. dollars. We record foreign gains and losses as they are realized. We mitigate our risk from foreign currency fluctuations by adjusting prices in our foreign markets on a periodic basis. We base these changes on market conditions while working closely with our representatives. We do not hedge currencies or enter into derivative contracts.

Item 4. Controls and Procedures

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of May 31, 2020. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, management concluded as of May 31, 2020, that our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

No change in the Company’s internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1.

Legal Proceedings

We are not a party to any legal proceedings and are not aware of any pending legal proceedings of any kind.

Item 1A.

Risk Factors

Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended August 31, 2019, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, as well as other risks and uncertainties, could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading price of shares of our Common Stock. Additional risks not currently known or currently material to us may also harm our business.

Our business is subject to risks arising from epidemic diseases, such as the recent outbreak of the COVID-19 illness.

The recent outbreak of the Coronavirus Disease 2019, or COVID-19, which has been declared by the World Health Organization to be a “public health emergency of international concern,” has spread across the globe and is impacting worldwide economic activity. A public health epidemic, including COVID-19, poses the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities. While it is not possible at this time to estimate the impact that COVID-19 could have on our business, the continued spread of COVID-19 and the measures taken by the governments of countries affected could disrupt the supply chain and adversely impact our business, financial condition or results of operations. The COVID-19 outbreak and mitigation measures may also have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition. The extent to which the COVID-19 outbreak impacts our results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of the virus and the actions to contain its impact.

Item 2.

Changes in Securities

None.

Item 3.

Defaults Upon Senior Securities

None.

Item 4.

Mine Safety Disclosures

N/A

Item 5.

Other Information

N/A

Item 6.

Exhibits

EXHIBIT NUMBER		DESCRIPTION
2.1 (4)^		Agreement and Plan of Merger, dated July 23, 2014, by and among the Company, Cognigen Corporation and the other parties thereto.
3.1 (2)		Articles of Incorporation of the Company.
3.2 (2)		Amended and Restated Bylaws of the Company.
4.1 (1)		Form of Common Stock Certificate.
4.2 (1)		Share Exchange Agreement.
10.1 (1) (†)		The Company’s 1996 Stock Option Plan and forms of agreements relating thereto.
10.2 (3) (†)		The Company’s 2007 Stock Option Plan, as amended.
10.3 (10)		Second Amendment to Lease by and between the Company and Crest Development LLC, dated as of May 1, 2016.
10.4 (5) (†)		Employment Agreement by and between the Company and Walter S. Woltosz, dated as of August 8, 2016.
10.5 (6)		Form of Indemnification Agreement.
10.6 (8)		2017 Equity Incentive Plan.
10.7 (7)		Stock Purchase Agreement by and among Simulation Plus, Inc., DILIsym Services, Inc., The Shareholders’ Representative and The Shareholders of DILIsym Services, Inc., dated as of May 1, 2017.
10.8 (9)(†)		Employment Agreement by and between the Company and Walter S. Woltosz, dated as of September 1, 2017.
10.9 (9) (†)		Employment Agreement by and between the Company and John DiBella, dated as of September 1, 2017.
10.10 (9) (†)		Employment Agreement by and between the Company and Thaddeus H Grasela Jr., dated as of September 2, 2017.
10.11 (11)(†)		Employment Agreement by and between the Company and Shawn O’Connor, dated as of June 26, 2018.
10.12 (12)		Stock Purchase and Contribution Agreement by and among the Shareholders of Lixoft, dated as of March 31, 2020
31.1		Section 302 – Certification of the Principal Executive Officer*
31.2		Section 302 – Certification of the Principal Financial Officer*
32		Section 906 – Certification of the Chief Executive Office and Chief Financial Officer**
101.INS		XBRL Instance Document.
101.SCH		XBRL Taxonomy Extension Schema Document.
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB		XBRL Taxonomy Extension Label Linkbase Document.
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document.

________________________

^	Schedules and exhibits omitted pursuant to Item 601(b)(2) of Registration S-K. The registrant agrees to furnish supplementally a copy of any omitted schedule to the SEC upon request.
†	Those exhibits marked with a (†) refer to management contracts or compensatory plans or arrangements
*	Filed herewith
**	Furnished herewith
(1)	Incorporated by reference to the Company’s Registration Statement on Form SB-2 (Registration No. 333-6680) filed on March 25, 1997.
(2)	Incorporated by reference to an exhibit to the Company’s Form 10-K for the fiscal year ended August 31, 2010.
(3)	Incorporated by reference to an exhibit to the Company’s Form 10-Q filed April 9, 2014.
(4)	Incorporated by reference to an exhibit to the Company’s Form 8-K/A filed November 18, 2014.
(5)	Incorporated by reference to an exhibit to the Company’s Form 8-K filed August 11, 2016.
(6)	Incorporated by reference to an exhibit to the Company’s Form 8-K filed August 10, 2016.
(7)	Incorporated by reference to an exhibit to the Company’s Form 10-Q filed July 10, 2017.
(8)	Incorporated by reference to Appendix A to the Company’s Schedule 14A filed December 29. 2016.
(9)	Incorporated by reference to an exhibit to the Company’s Form 8-K filed September 6, 2017.
(10)	Incorporated by reference to an exhibit to the Company’s Form 10-K for the fiscal year ended August 31, 2016.
(11)	Incorporated by reference to an exhibit to the Company’s Form 10-Q filed July 10, 2018.
(12)	Incorporated by reference to an exhibit to the Company’s Form 8-K filed April 2, 2020.

SIGNATURE

In accordance with Section 13 or 15 (d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Lancaster, State of California, on July 9, 2020.

		Simulations Plus, Inc.


Date:	July 9, 2020	By: /s/ John R Kneisel
		John R. Kneisel
		Chief Financial Officer

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