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EX-32 - CERTIFICATION - Simulations Plus, Inc.simulations_10q-ex3200.htm
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EX-31.1 - RULE 13A-14(A) CERTIFICATION - Simulations Plus, Inc.simulations_10q-ex3101.htm
EX-10.10 - EMPLOYMENT AGREEMENT - SHAWN O'CONNOR - Simulations Plus, Inc.simulations_10q-ex1010.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, 2018
     
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 10th Street West

Lancaster, CA 93534-7059

(Address of principal executive offices including zip code)

 

(661) 723-7723

(Registrant’s telephone number, including area code)

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒     No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 10, 2018 was 17,365,084; no shares of preferred stock were outstanding.

 

 

 

   

 

 

Simulations Plus, Inc.

FORM 10-Q

For the Quarterly Period Ended May 31, 2018

 

Table of Contents

 

PART I. FINANCIAL INFORMATION
    Page
Item 1. Condensed Consolidated Financial Statements  
     
  Condensed Consolidated Balance Sheets at May 31, 2018 (unaudited) and August 31, 2017 (audited) 3
     
  Condensed Consolidated Statements of Operations for the three months and nine months ended May 31, 2018 and May 31, 2017 (unaudited) 4
     
  Condensed Consolidated Statements of Cash Flows for the nine months ended May 31, 2018 and May 31, 2017 (unaudited) 5
     
  Notes to Condensed Consolidated Financial Statements (unaudited) 6
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Result of Operations 19
     
  General 19
     
  Result of Operations 30
     
  Liquidity and Capital Resources 34
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 35
     
Item 4. Controls and Procedures 35
     
PART II. OTHER INFORMATION
     
Item 1. Legal Proceedings 36
     
Item 1A. Risk Factors 36
     
Item 2. Changes in Securities 36
     
Item 3. Defaults upon Senior Securities 36
     
Item 4. Mine Safety Disclosures 36
     
Item 5. Other Information 36
     
Item 6. Exhibits 37
     

Signature

38

 

 

 

 

 i 

 

 

Part I. FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements

 

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

As of

 

   (Unaudited)   (Audited) 
   May 31,   August 31, 
ASSETS        
   2018   2017 
Current assets          
Cash and cash equivalents  $7,223,115   $6,215,718 
Accounts receivable, net of allowance for doubtful accounts of $0   7,701,659    4,048,725 
Revenues in excess of billings   2,018,419    1,481,082 
Prepaid income taxes       462,443 
Prepaid expenses and other current assets   383,655    459,902 
Total current assets   17,326,848    12,667,870 
Long-term assets          
Capitalized computer software development costs, net of accumulated amortization of $10,748,363 and $9,795,469     4,986,428       4,307,600  
Property and equipment, net (note 3)   279,105    291,135 
Intellectual property, net of accumulated amortization of $2,788,543 and $2,095,417   6,136,458    6,829,583 
Other intangible assets net of accumulated amortization of $763,125 and $495,000   3,726,875    3,995,000 
Goodwill   10,387,198    10,387,198 
Other assets   37,227    34,082 
Total assets  $42,880,139   $38,512,468 
           
LIABILITIES AND SHAREHOLDERS' EQUITY          
Current liabilities          
Accounts payable   197,110   $240,892 
Accrued payroll and other expenses   1,106,195    983,293 
Income taxes payable   169,452     
Current portion - Contracts payable (note 4)   2,480,000    247,328 
Billings in excess of revenues   434,804    216,958 
Deferred revenue   821,243    353,962 
Total current liabilities   5,208,804    2,042,433 
           
Long-term liabilities          
Deferred income taxes, net   3,189,761    4,926,960 
Payments due under Contracts payable (note 4)   3,372,752    5,738,188 
Total liabilities   11,771,317    12,707,581 
           
Commitments and contingencies (note 5)          
           
Shareholders' equity (note 6)          
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 17,358,444 and 17,277,604 shares issued and outstanding   7,359    7,278 
Additional paid-in capital   12,933,560    12,109,141 
Retained earnings   18,167,903    13,688,468 
Total shareholders' equity   31,108,822    25,804,887 
           
Total liabilities and shareholders' equity  $42,880,139   $38,512,468 

  

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

 

 

 

 3 

 

 

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the three and nine months ended May 31, 2018 and May 31, 2017

 

   Three months ended   Nine months ended 
   (Unaudited)   (Unaudited) 
   2018   2017   2018   2017 
                 
Revenues  $8,553,068   $6,748,518   $22,978,565   $17,872,044 
Cost of revenues   2,022,972    1,444,764    5,874,062    4,334,699 
Gross margin   6,530,096    5,303,754    17,104,503    13,537,345 
Operating expenses                    
Selling, general, and administrative   2,604,168    1,954,871    7,352,404    5,766,563 
Research and development   508,356    253,799    1,353,503    952,635 
Total operating expenses   3,112,524    2,208,670    8,705,907    6,719,198 
                     
Income from operations   3,417,572    3,095,084    8,398,596    6,818,147 
                     
Other income (expense)                    
Interest income   7,825    4,663    18,313    13,548 
Interest expense   (38,188)       (114,846)    
Gain(loss) on currency exchange   9,441    (14,913)   (3,820)   5,573 
Total other income (expense)   (20,922)   (10,250)   (100,353)   19,121 
                     
Income before provision for income taxes   3,396,650    3,084,834    8,298,243    6,837,268 
Benefit (Provision) for income taxes   (990,613)   (1,004,805)   (701,415)   (2,199,914)
Net Income  $2,406,037   $2,080,029   $7,596,828   $4,637,354 
                     
Earnings per share                    
Basic  $0.14   $0.12   $0.44   $0.27 
Diluted  $0.13   $0.12   $0.43   $0.27 
                     
Weighted-average common shares outstanding                    
Basic   17,339,937    17,241,891    17,308,414    17,233,470 
Diluted   17,904,428    17,585,528    17,850,171    17,454,864 

  

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

 

 

 

 4 

 

 

SIMULATIONS PLUS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the nine months ended May 31, 2018 and May 31, 2017

(UNAUDITED)

 

   2018   2017 
Cash flows from operating activities          
Net income  $7,596,828   $4,637,354 
Adjustments to reconcile net income to net cash provided by operating activities          
Depreciation and amortization   2,015,825    1,547,041 
Change in value of contingent consideration   114,564     
Stock-based compensation   514,416    355,365 
Deferred income taxes   (1,737,199)   99,259 
(Increase) decrease in          
Accounts receivable   (3,652,934)   (2,001,072)
Revenues in excess of billings   (537,337)   (436,023)
Prepaid income taxes   462,443    313,946 
Prepaid expenses and other assets   73,102    106,403 
Increase (decrease) in          
Accounts payable   (43,782)   103,534 
Accrued payroll and other expenses   122,902    90,343 
Billings in excess of revenues   217,846    83,299 
Accrued income taxes   169,452     
Other liabilities       (8,274)
Deferred revenue   467,281    (127,458)
Net cash provided by operating activities   5,783,407    4,763,717 
           
Cash flows used in investing activities          
Purchases of property and equipment   (89,648)   (117,519)
Capitalized computer software development costs   (1,631,724)   (928,460)
Net cash used in investing activities   (1,721,372)   (1,045,979)
           
Cash flows used in financing activities          
Payment of dividends   (3,117,393)   (2,585,043)
Payments on Contracts Payable   (247,328)   (1,000,000)
Proceeds from the exercise of stock options   310,083    85,218 
Net cash used in financing activities   (3,054,638)   (3,499,825)
           
Net increase (decrease) in cash and cash equivalents   1,007,397    217,913 
Cash and cash equivalents, beginning of year   6,215,718    8,030,284 
Cash and cash equivalents, end of period  $7,223,115   $8,248,197 
           
Supplemental disclosures of cash flow information          
Income taxes paid  $1,763,825   $1,765,189 

  

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

 

 

 

 5 

 

 

Simulations Plus, Inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

May 31, 2018

(Unaudited)

 

NOTE 1: GENERAL

 

This report on Form 10-Q for the quarter ended May 31, 2018, should be read in conjunction with the Company's annual report on Form 10-K for the year ended August 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on November 14, 2017. As contemplated by the SEC under Article 3 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. (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 and June 1, 2017, respectively, its wholly owned subsidiaries, Cognigen Corporation and DILIsym Services, Inc. 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

We recognize revenues related to software licenses and software maintenance in accordance with the FASB Accounting Standards Codification (“ASC”) 985-605, “Software – Revenue Recognition”. Software product revenue is recorded when the following conditions are met: 1) evidence of arrangement exists; 2) delivery has been made; 3) the amount is fixed; and 4) collectability is probable. Post-contract customer support (“PCS”) obligations are insignificant; therefore, revenue for PCS is recognized at the same time as the licensing fee, and the costs of providing such support services are accrued and amortized over the obligation period.

  

 

 

 6 

 

 

As a byproduct of ongoing improvements and upgrades for the new programs and new modules of software, some modifications are provided to our customers who have already purchased software at no additional charge. Other software modifications result in new, additional-cost modules that expand the functionality of the software. These are licensed separately. We consider the modifications that are provided without charge to be minimal, as they do not significantly change the basic functionality or utility of the software, but rather add convenience, such as being able to plot some additional variable on a graph in addition to the numerous variables that had been available before, or adding some additional calculations to supplement the information provided from running the software. Such software modifications for any single product have typically occurred once or twice per year, sometimes more, sometimes less. Thus, they are infrequent. The Company provides, for a fee, additional training and service calls to its customers and recognizes revenue at the time the training or service call is provided.

 

Generally, we enter into one-year license agreements with customers for the use of our pharmaceutical software products. We recognize revenue on these contracts when all the criteria are met. Most license agreements have a term of one year; however, from time to time, we enter into multiyear license agreements. We generally unlock and invoice software one year at a time for multiyear licenses. Therefore, revenue is recognized one year at a time. Certain of the Company's software products are housed and supported on the Company's computer networks. Software revenues for those products are included in income over the life of the contract.

  

We recognize revenue on sales of our DILIsym subsidiary in accordance with ASC 605-25, “Revenue Recognition, Multiple-Element Arrangements”. Our multiple-deliverable arrangements consist of consulting arrangements at our DILIsym subsidiary. We determined all elements to be separate units of accounting as they have standalone value to the customers. We allocate the revenue derived from these arrangements among all the deliverables. We base such allocation on the relative selling price of each deliverable. We recognize the allocated revenue for each deliverable when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured.

 

We recognize revenue from collaboration research, revenue from grants, and consortium memberships over their terms. For contract revenues based on actual hours incurred, we recognize revenues when the work is performed. For fixed-price contracts, we recognize contract study and other contract revenues using the percentage-of-completion method, depending upon how the contract studies are engaged, in accordance with ASC 605-35, “Revenue Recognition – Construction-Type and Production-Type Contracts”. To recognize revenue using the percentage-of-completion method, we must determine whether we meet the following criteria: 1) there is a long-term, legally enforceable contract, 2) it is possible to reasonably estimate the total project costs, and 3) it is possible to reasonably estimate the extent of progress toward completion.

 

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.

  

 

 

 7 

 

 

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 $331,862 and $290,567 for the three months ended May 31, 2018 and 2017, respectively, and $952,894 and $864,443 for the nine months ended May 31, 2018 and 2017, 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.

 

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 noncompete 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, 2018, the Company determined that it has three reporting units, Simulations Plus, Cognigen Corporation, and DILIsym Services, Inc. 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, 2018, the entire balance of goodwill was attributed to two of the Company's reporting units, Cognigen Corporation and DILIsym Services. 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. There were no changes to goodwill, nor has the Company recognized any impairment charges, during the three-month periods ended May 31, 2018 and 2017.

  

 

 

 8 

 

 

Business Acquisitions

The Company accounted for the acquisition of Cognigen and DILIsym Services, Inc., using the purchase method of accounting where the assets acquired and liabilities assumed are recognized based on their respective estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Determining the fair value of certain acquired assets and liabilities is subjective in nature and often involves the use of significant estimates and assumptions, including, but not limited to, the selection of appropriate valuation methodology, projected revenue, expenses and cash flows, weighted average cost of capital, discount rates, estimates of advertiser and publisher turnover rates, and estimates of terminal values. Business acquisitions are included in the Company's consolidated financial statements as of the date of the acquisition.

 

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, 2018 and August 31, 2017 for assets and liabilities measured at fair value on a recurring basis:

 

May 31, 2018:

 

   Level 1   Level 2   Level 3   Total 
Cash and cash equivalents  $7,223,115   $   $   $7,223,115 
Acquisition-related contingent consideration obligations  $   $   $4,852,752   $4,852,752 

 

August 31, 2017:

   Level 1   Level 2   Level 3   Total 
Cash and cash equivalents  $6,215,718   $   $   $6,215,718 
Acquisition-related contingent consideration obligations  $   $   $4,738,188   $4,738,188 

 

As of May 31, 2018, and August 31, 2017, the Company has a liability for contingent consideration related to its acquisition of the DILIsym Services, Inc. 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.

  

The following is a reconciliation of contingent consideration value.

 

Value at August 31, 2017   $ 4,738,188  
Contingent consideration payments      
Change in value of contingent consideration     114,564  
Value at May 31, 2018   $ 4,852,752  

  

 

 

 9 

 

 

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, 2018 and 2017 was $1,875, and was $5,625 for each of the nine-month periods ended May 31, 2018, and 2017. Accumulated amortization as of May 31, 2018 and August 31, 2017 were $46,875 and $41,250, 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, 2018 and 2017 was $150,000, and $450,000 for each of the nine-month periods ended May 31, 2018 and 2017. Accumulated amortization as of May 31, 2018 and August 31, 2017 were $2,425,000 and $1,975,000, respectively.

 

On June 1, 2017, as part of the acquisition of DILIsym Services, Inc. the Company acquired certain developed technologies associated with 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, 2018 was $79,176 and $237,500, respectively, and is included in cost of revenues. Accumulated amortization as of May 31, 2018 and August 31, 2017 was $316,667 and $79,176, respectively.

 

Total amortization expense for intellectual property agreements for the three months and nine months ended May 31, 2018 and 2017 was $231,042 and $151,875, respectively, and total amortization expense for the nine months ended May 31, 2018 and 2017 was $693,125 and $455,625 respectively. Accumulated amortization as of May 31, 2018 was $2,788,542 and $2,095,417 as of August 31, 2017.

  

Intangible assets

The following table summarizes those intangible assets as of May 31, 2018:

 

   Amortization
Period
  Acquisition
Value
   Accumulated
Amortization
   Net book
value
 
Customer relationships - Cognigen  Straight line 8 years 

$

 

1,100,000  

$

 

515,625  

$

 

584,375 
Trade Name - Cognigen  None   500,000    0    500,000 
Covenants not to compete - Cognigen  Straight line 5 years   50,000    37,500    12,500 
Covenants not to compete - DILIsym  Straight line 4 years   80,000    20,000    60,000 
Trade Name - DILIsym  None   860,000    0    860,000 
Customer relationships - DILIsym  Straight line 8 years   1,900,000    190,000    1,710,000 
      $4,490,000   $763,125   $3,726,875 

  

 

 

 10 

 

 

Amortization expense for each of the three-month and nine-month periods ended May 31, 2018 and 2017 was $89,375 and $36,875, and $268,125 and $110,625, 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 is computed 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, 2018 and 2017 were as follows:

 

   Three months ended   Nine months ended 
    5/31/2018    5/31/2017    5/31/2018    5/31/2017 
Numerator:                    
Net income attributable to common shareholders  $2,406,927   $2,080,029   $7,596,828   $4,637,354 
Denominator:                    
Weighted-average number of common shares outstanding during the period   17,339,937    17,241,891    17,308,414    17,233,470 
Dilutive effect of stock options   564,491    343,637    541,757    221,394 
Common stock and common stock equivalents used for diluted earnings per share   17,904,428    17,585,528    17,850,171    17,454,864 

 

 

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 $132,437 and $142,879 for the three months ended May 31, 2018 and 2017, respectively and $404,154 and $355,365 for the nine months ended May 31, 2018 and 2017, 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, 2018 and 2017.

  

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 and interim 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.

  

 

 

 11 

 

 

In May 2014, the Franchise Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09). The standard will eliminate the transaction- and industry-specific revenue recognition guidance under current generally accepted accounting principles in the U.S. (GAAP) and replace it with a principles-based approach for determining revenue recognition. ASU 2014-09 is effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for years beginning after December 15, 2016. The revenue recognition standard is required to be applied retrospectively, including any combination of practical expedients as allowed in the standard. We are evaluating the impact, if any, of the adoption of ASU 2014-09 to our financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. 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 should be adopted concurrently with adoption of ASU 2014-09 which is effective for annual and interim periods beginning after December 15, 2017. The Company has commenced its assessment of these new standards, developed a project plan to guide the implementation, and is evaluating the impact these new standards will have on its consolidated financial statements. In the second and third quarters, the company executed a project to evaluate the impact of these changes, which included a review of existing contracts with customers, an evaluation of the specific terms of those contracts and the appropriate treatment under the new standards, and a comparison of that new treatment to the Company’s existing accounting policies, to identify differences. This project is well advanced and key findings and conclusions are currently being discussed. The standard can be applied either retrospectively to each period presented or as a cumulative effect adjustment as of the date of adoption. The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption. In the fourth quarter the Company will complete its analysis, draft disclosures, and calculate any transition adjustment, if required, once the analysis is complete. The Company believes that it is following an appropriate timeline to allow for proper adoption on the implementation date of September 1, 2018. The company will continue to monitor new customer contracts until the transition date.

  

NOTE 3: Property and Equipment

 

Property and equipment as of May 31, 2018 consisted of the following:

 

Equipment  $674,145 
Computer equipment   265,925 
Furniture and fixtures   145,240 
Leasehold improvements   107,572 
Sub total   1,192,882 
Less: Accumulated depreciation and amortization   (913,777)
Net Book Value  $279,105 

  

NOTE 4: 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 will be due starting in FY 2019. It is estimated that approximately 38% of the Earn-out liability as well as the holdback will be paid in 2019 and the majority of the remaining Earn-out will be paid in the following year.

  

As of May 31, 2018 and August 31, 2017 the following liabilities have been recorded:

 

   May 31,
2018
   August 31,
2017
 
Working Capital Liability  $   $247,328 
Holdback Liability   1,000,000    1,000,000 
Earn-out Liability   4,852,752    4,738,188 
Sub Total  $5,852,752   $5,985,516 
Less: Current Portion   2,480,000    247,328 
Long-Term  $3,372,752   $5,738,188 

  

 

 

 12 

 

 

NOTE 5: 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 expires in October 2018; the lease allows for a three-year option to extend to October 2021. The current base rent is $15,638 per month.

 

In September 2017 DILIsym signed a three-year lease for approximately 1,900 rentable square feet of space in Research Triangle Park, North Carolina. The initial three-year term expires in October 2020. The base rent is $5,021 per month with an annual 3% adjustment. Prior to this lease DILIsym was on a month-to-month rental.

 

Rent expense, including common area maintenance fees for the three months ended May 31, 2018, and 2017 was $144,589 and $128,011, respectively, and $424,077 and $375,564 for the nine months ended May 31, 2018 and 2017, respectively.

 

  

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 executed a royalty agreement with Accelrys, Inc. (“Accelrys”) (the original agreement was entered into with Symyx Technologies in March 2010; Symyx Technologies later merged with Accelrys, Inc.) 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 pay a royalty of 25% of revenue derived from the sale of the Metabolism/Metabolite module to Accelrys. In 2014, Dassault Systemes of France acquired Accelrys and the Company now operates under the name BIOVIA. We incurred royalty expense of $44,835 and $35,494, respectively, and for the three months ended May 31, 2018 and 2017, respectively and $124,567 and $108,587 for the nine months ended May 31, 2018 and 2017, 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 2018. We file income tax returns with the IRS and various state jurisdictions and India. Our federal income tax returns for fiscal year 2015 and 2017 are open for audit, and our state tax returns for fiscal year 2014 through 2017 remain open for 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

From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business. Litigation can be expensive and disruptive to normal business operations. Moreover, the results of legal proceedings, particularly complex legal proceedings, cannot be predicted with any certainty.

 

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

 

 

 

 13 

 

 

NOTE 6: SHAREHOLDERS’ EQUITY

 

Dividend

The Company’s Board of Directors declared cash dividends during fiscal years 2018 and 2017. The details of the dividends paid are in the following tables:

 

FY2018 
Record Date  Distribution Date   Number of Shares
Outstanding on
Record Date
    Dividend per
Share
    Total
Amount
 
11/13/2017  11/20/2017   17,284,792   $0.06   $1,037,088 
1/26/2018  2/2/2018   17,317,752    0.06    1,039,065 
4/25/2018  5/2/2018   17,354,005    0.06    1,041,240 
Total               $3,117,393 

 

FY2017 
Record Date  Distribution Date   Number of Shares
Outstanding on
Record Date
    Dividend per
Share
    Total
Amount
 
11/10/2016  11/17/2016   17,226,478   $0.05   $861,324 
1/30/2017  2/6/2017   17,233,758    0.05    861,688 
5/08/2017  5/15/2017   17,240,626    0.05    862,031 
7/28/2017  8/4/2017   17,268,920    0.05    863,446 
Total               $3,448,489 

   

Equity Incentive 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, 2018, employees and directors hold stock options to purchase 1,161,976 shares of common stock at exercise prices ranging from $1.00 to $17.71.

  

The following table summarizes information about stock options:

 

Transactions in FY18  Number of
Options
   Weighted-
Average
Exercise
Price
Per Share
   Weighted-
Average
Remaining
Contractual
Life
 
Outstanding, August 31, 2017   1,249,126   $8.51    7.52 
Granted   12,000   $17.71      
Exercised   (74,075)  $5.78      
Cancelled/Forfeited   (19,075)  $8.89      
Expired   (6,000)  $5.06      
Outstanding, May 31, 2018   1,161,976   $8.79    7.31 
Exercisable, May 31, 2018   472,755   $7.66    6.45 

 

 

 

 14 

 

 

The weighted-average remaining contractual life of options outstanding issued under the Plan was 7.31 years at May 31, 2018. The exercise prices for the options outstanding at May 31, 2018 ranged from $1.00 to $17.71, 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
 
$ 1.00     $ 4.00       42,000       0.85 years     $ 1.00       42,000       0.85 years     $ 1.00  
$ 4.01     $ 8.00       332,000       5.96 years     $ 6.76       207,795       5.78 years     $ 6.70  
$ 8.01     $ 12.00       763,060       8.26 years     $ 9.87       222,960       8.12 years     $ 9.81  
$ 12.01     $ 16.00       12,916       9.22 years     $ 14.44       0           $  
$ 16.01     $ 17.71       12,000       4.46 years     $ 17.71       0           $  
                  1,161,976       7.31 years     $ 8.79       472,755       6.45 years     $ 7.66  

 

During the three and nine-month periods ended May 31, 2018, the Company issued 2,232 and 6,765 shares of stock to non-management directors of the Company valued at $36,716 and $110,262, respectively as compensation for services rendered to the Company.

  

NOTE 7: 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, 2018 the Company had cash and cash equivalents exceeding insured limits by $6,254,000.

 

Revenue concentration shows that international sales accounted for 41% and 34% of net sales for the nine months ended May 31, 2018 and 2017, respectively. Three customers accounted for 9% (a dealer account in Japan representing various customers), 7%, and 5% of net sales during the nine months ended May 31, 2018. Three customers accounted for 8%, 6% (a dealer account in Japan representing various customers), and 5% of sales for the nine months ended May 31, 2017.

  

Accounts receivable concentration shows that six customers comprised 13% (a dealer account in Japan representing various customers), 9%, 6%, 6%, 5%, and 5% of accounts receivable at May 31, 2018, compared to three customers comprising 14% and 12% (a dealer account in Japan representing various customers) and 8% of accounts receivable at May 31, 2017.

 

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 to 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 8: 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.

 

 

 

 15 

 

 

Results for each segment and consolidated results are as follows for the three-month periods ended May 31, 2018 and 2017 (in thousands, because of rounding numbers may not foot):

 

Three months ended May 31, 2018
   Lancaster   Buffalo   North Carolina*   Eliminations   Total 
Net revenues  $5,654   $1,942   $957   $   $8,553 
Income (loss) from operations   3,031    384    3        3,418 
Total assets   35,009    11,180    14,393    (17,702)   42,880 
Capital expenditures   9    17            26 
Capitalized software costs   318    165            484 
Depreciation and amortization   437    105    146        688 

*Acquired June 1, 2017

 

Three months ended May 31, 2017
   Lancaster   Buffalo   Eliminations   Total 
Net revenues  $4,948   $1,801   $   $6,749 
Income (loss) from operations   2,681    414        3,095 
Identifiable assets   27,428    9,358    (7,238)   29,548 
Capital expenditures   12    0        12 
Capitalized software costs   278    66        344 
Depreciation and amortization   422    92        514 

  

Nine months ended May 31, 2018
   Lancaster   Buffalo   North Carolina*   Eliminations   Total 
Net revenues  $14,247   $5,722   $3,010   $   $22,979 
Income (loss) from operations   6,566    1,220    613        8,399 
Total assets   35,009    11,180    14,393    (17,702)   42,880 
Capital expenditures   37    40    13        90 
Capitalized software costs   1,011    466    155        1,632 
Depreciation and amortization   1,295    295    426        2,016 

*Acquired June 1, 2017

  

Nine months ended May 31, 2017
   Lancaster   Buffalo   Eliminations   Total 
Net Revenues  $12,685   $5,187   $   $17,872 
Income (loss) from operations   5,739    1,079        6,818 
Total assets   27,428    9,358    (7,238)   29,548 
Capital expenditures   37    80        117 
Capitalized software costs   809    120        929 
Depreciation and Amortization   1,261    286        1,547 

 

 

 

 16 

 

 

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, 2018 and 2017 were as follows (in thousands, because of rounding numbers may not foot):

 

Three months ended May 31, 2018
   North America   Europe   Asia   South America   Total 
Lancaster  $2,595   $1,367   $1,692   $   $5,654 
Buffalo   1942                1,942 
North Carolina*   715    150    92        957 
Total  $5,252   $1,517   $1,784   $   $8,553 

*Acquired June 1, 2017

 

Three months ended May 31, 2017 
   North America   Europe   Asia   South America   Total 
Lancaster  $2,533   $1,144   $1,271   $   $4,948 
Buffalo   1,801    0    0        1,801 
Total  $4,334   $1,144   $1,271   $1   $6,749 

 

Nine months ended May 31, 2018
   North America   Europe   Asia   South America   Total 
Lancaster  $6,126   $4,201   $3,905   $15   $14,247 
Buffalo   5,722                5,722 
North Carolina*   2,249    195    566        3,010 
Total  $14,097   $4,396   $4,471   $15   $22,979 

*Acquired June 1, 2017

 

Nine months ended May 31, 2017* 
   North America   Europe   Asia   South America   Total 
Lancaster  $6,261   $3,201   $3,222   $1   $12,685 
Buffalo   5,187                5,187 
Total  $11,448   $3,201   $3,222   $1   $17,872 

  

NOTE 9: 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 $95,585 and $64,233 for the three months ended May 31, 2018 and 2017, respectively and $238,011 and $179,123 for the nine months ended May 31, 2018 and 2017 respectively.

 

NOTE 10: ACQUISITION/MERGER WITH SUBSIDIARIES

 

DILIsym Services, Inc.

On May 1, 2017, the Company entered into a Stock Purchase Agreement (the “Stock Agreement”) with DILIsym Services, Inc. (“DILIsym”). On June 1, 2016, 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. We believe the combination of Simulations Plus and DILIsym provides substantial future potential based on the complementary strengths of each of the companies.

 

 

 

 17 

 

 

Under the terms of the Stock Agreement, as described below, the Company will pay the former shareholders of DILIsym total consideration of approximately $10,463,000.

 

On June 1, 2017, the Company paid the former shareholders of DILIsym a total of $4,515,982, which included a $4,000,000 initial payment and a preliminary working capital payment of $515,982. Additional working capital adjustments of $247,328 were due under the agreement and were paid subsequent to August 31, 2017.

 

Within three business days following the eighteen-month anniversary of the date of the Stock Agreement, May 1, 2017, and subject to any offsets, the Company will pay the former shareholders of DILIsym a total of $1,000,000. The agreement calls for Earn-out payments up to an additional $5,000,000 based on a formula of pretax earnings over the next three years. The Earn-out liability has been recorded at fair value.

 

Under the acquisition method of accounting, the total estimated purchase price is allocated to DILIsym’s tangible and intangible assets and liabilities based on their estimated fair values at the date of the completion of the acquisition (June 1, 2017). The following table summarizes the preliminary allocation of the purchase price for DILIsym:

 

Assets acquired, including accounts receivable of $255,000 and estimated Contracts receivable of $153,000   $ 2,298,569  
Developed Technologies Acquired     2,850,000  
Estimated value of Intangibles acquired (Customer Lists, trade name etc.)     2,840,000  
Current Liabilities assumed     (911,049 )
Goodwill     5,597,950  
Estimated Deferred income taxes     (2,212,160 )
         
Total Consideration   $ 10,463,310  

  

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. Based on the structure of the transaction, the Company does not anticipate benefiting from any tax deductions in future periods for recognized goodwill.

  

PROFORMA INFORMATION (UNAUDITED)

 

Consolidated supplemental Pro Forma information

The following consolidated supplemental pro forma information assumes that the acquisition of DILIsym took place on September 1, 2016 for the income statement for the three-month and nine-month periods ended May 31, 2017. These amounts have been calculated after applying the Company’s accounting policies and adjusting the results of DILIsym to reflect the same expenses in the three-month period ended May 31, 2017. 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, 2016, 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)

 
   (Actual)   (Pro forma)   (Actual)   (Pro forma) 
   2018   2017   2018   2017 
Net Sales  $8,553   $8,340   $22,979   $20,918 
Net Income  $2,406   $2,563   $7,597   $5,090 

 

NOTE 11 - SUBSEQUENT EVENTS:

 

On June 26, 2018, the Company announced the appointment of a new Chief Executive Officer(CEO), Shawn O’Connor, who replaces the founding CEO, Walter S. Woltosz. Mr. Woltosz will remain as Chairman of the Board of Directors.

 

On July 6, 2018, our Board of Directors declared a quarterly cash dividend of $0.06 per share to our shareholders. The dividend will be distributed on Thursday August 2, 2018, for shareholders of record as of Wednesday July 26, 2018.

  

 

 

 

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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 groundbreaking drug discovery and development software for mechanistic modeling and simulation, and for machine-learning-based prediction of properties of molecules solely from their structure, and is exploring the application of its machine-learning technologies in other industries. 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 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 are one of only two global companies who 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.

 

 

 

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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 knowledge to guide early drug discovery (molecule design and screening), preclinical, and clinical development programs. They also use it 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.

 

In September 2014, Simulations Plus acquired Cognigen Corporation (Cognigen) as a wholly owned subsidiary pursuant to that certain Agreement and Plan of Merger, dated as of July 23, 2014, by and between Simulations Plus and Cognigen (the “Merger Agreement”). Cognigen was originally incorporated in 1992. Through the integration of Cognigen into Simulations Plus, Simulations Plus became also 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.

   

In June 2017, Simulation Plus 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. We believe the combination of Simulations Plus and DILIsym provides substantial future potential based on the complementary strengths of each of the companies. The acquisition of DILIsym positions the Company as the leading provider of Drug Induced Liver Injury (DILI) modeling and simulation software and contract research 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™. The difference between DILIsym and NAFLDsym is that DILIsym estimates the potential for a particular drug molecule to induce liver injury (i.e., to cause damage), while NAFLDsym estimates the likelihood of new molecules to treat nonalcoholic fatty liver disease (i.e., to repair damage), and is unique to the mechanisms involved in such treatment. As such, DILIsym can be a single program that addresses a wide variety of molecules across various companies, while NAFLDsym requires customizing the software for each mechanism of action. 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.

 

PRODUCTS

 

General

 

We currently offer ten software products for pharmaceutical 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™; three programs that are based on predicting and analyzing static (not time-dependent) properties of chemicals: ADMET Predictor™; MedChem Designer™; and MedChem Studio™ (the combination of ADMET Predictor, MedChem Designer, and MedChem Studio is called our ADMET Design Suite™); our newest program which is designed for rapid clinical trial data analysis and regulatory submissions called PKPlus™; and a program called KIWI™ from our Cognigen division that provides an integrated platform for data analysis and reporting through our proprietary secure cloud.

 

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 pharmaceutical companies, 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 other countries.

 

 

 

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Because of the widespread use of GastroPlus, we were the only non-European company invited to join the European Innovative Medicines Initiative (IMI) program for Oral Bioavailability Tools (OrBiTo). OrBiTo, begun in 2012 and completed in 2017, was an international collaboration among 27 industry, academic, and government organizations working in the area of oral absorption of pharmaceutical products. Because we are outside of the European Union, our participation in this project was at our own expense, while other members were compensated for their work; however, we were a full member with access to all of the data and discussions of all other members. We believe our investment to participate in this initiative enabled us to benefit from, and to contribute to, advancing the prediction of human oral bioavailability from preclinical data, and ensured that we are well-known to member pharmaceutical companies and regulatory agencies.

 

In September 2016, we announced that Simulations Plus had been invited to join the European SimInhale Consortium and had been admitted to this prestigious group focused on advancing the state of the art for simulation of inhaled dosage forms. As one of only two U.S. participants, Simulations Plus is participating in activities designed to advance particle designs for improved deposition and interaction with lung tissue; promote realistic computer simulations of particle aerosolization, delivery, and deposition; promote patient-tailored inhaled medicines; promote integration of device and formulation design; and promote critical assessment of toxicity issues and related risks.

 

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 Dosing 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. Under this RCA, we received up to $200,000 per year. This RCA could be renewed for up to a total of three years based on the progress achieved during the project. After a successful second year, the RCA was extended for two additional years in September 2016 and will be completed in September 2018.

 

We were awarded another RCA by the FDA in September 2015; this one to expand the capabilities of GastroPlus to simulate the dosing of long-acting injectable microspheres for both small and large molecules (biologics). This type of dosage form is usually injected via subcutaneous or intramuscular routes. This RCA also provides up to $200,000 per year for up to three years. Under this agreement, we are developing 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 will be completed in September 2018 unless extended.

 

In addition to the two funded efforts with the FDA described above, we also have an unfunded RCA with the FDA’s Office of Generic Drugs (OGD) that began in 2014. The objective of this RCA, which has a five-year term, 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.

 

In May 2018, we released Version 9.6 of GastroPlus. Version 9.6 is the most feature-rich and user-friendly release in our history. New functionalities that we believe provide the most advanced decision-making tool for preclinical and early clinical trial simulation and modeling analysis available today include:

 

·New dynamic intestinal fluid options added to the #1-ranked ACAT™ oral absorption model
·New population physiologies for obesity and renal impairment disease states
·Expanded enzyme/transporter distribution information for easier extrapolation across species
·Additional compound model files for standard drug-drug interaction (DDI) substrates & inhibitors
·Upgraded capabilities to all major mechanistic absorption routes, including dermal, pulmonary, ocular, and subcutaneous/intramuscular injections
·Enhanced deconvolution methods for generation of mechanistic in vitro-in vivo correlations (IVIVCs)
·Improved output/reporting functions in all simulation modes to facilitate communication across departments and with regulatory agencies
·Significant simulation speed improvements
·Custom template generation for seamless use of GastroPlus to drive DILIsym® SimPops™ liver injury predictions

 

 

 

 

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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 physiologically based pharmacokinetics (PBPK), 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.

 

Version 9.7 is now in development and release is expected in early 2019. This version will add a number of important new capabilities, including improvements to population simulations, dissolution, absorption, metabolism, and drug-drug interactions, among others.

 

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, and (3) design in vitro dissolution experiments to better mimic in vivo (animal and human) conditions. Version 5.0 of DDDPlus, which added a number of significant enhancements, was released in April 2016. This version added new formulation types (controlled release bilayer tablet, delayed release coated tablet, and immediate release coated beads), expanded formulation specification options, biorelevant solubilities and surfactant effects on dissolution, tablet compression and disintegration models, links with GastroPlus, and updated licensing. Current improvements in development and testing include new capabilities to simulate in vitro dissolution experiments for long-acting injectable microspheres as part of our work under the FDA-funded grant mentioned above.

 

Version 6.0 of DDDPlus is in development testing and will offer a series of new capabilities, including:

 

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

 

MembranePlus™

MembranePlus was released in October 2014. Similar to DDDPlus, MembranePlus mechanistically simulates laboratory experiments, but in this case, the experiments are for measuring permeability of drug-like molecules through various membranes, including several different standard cell cultures (Caco-2, MDCK), as well as artificially formulated membranes (PAMPA). The value of such simulations derives from the fact that when the permeabilities of 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 in human and animals, which is the ultimate goal.

 

Version 2.0 of MembranePlus was released in August 2017. This version added:

  · simulation of sandwich hepatocyte assays
  · simulation of suspended hepatocyte assays
  · intracellular protein binding
  · integration of ADMET Predictor metabolism predictions
  · improved output reporting

  

 

 

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PKPlus™

On August 25, 2016, we announced the release of a new standalone software product called PKPlus, based on the internal PKPlus Module in GastroPlus that has been available since 2000. The PKPlus Module in GastroPlus provides quick and easy fitting of compartmental pharmacokinetic (PK) models as well as a simple noncompartmental analysis (NCA) for intravenous and extravascular (oral, dermal, ocular, pulmonary, etc.) doses; however, the PKPlus Module in GastroPlus was not designed to meet all of the requirements for performing these analyses for Phase 2 and 3 clinical trials, nor to produce report-quality output for regulatory submissions. The standalone PKPlus program 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 both more complex NCA as well as compartmental PK modeling. After receiving considerable feedback on version 1.0, we began modifying the program to include a number of additional features requested by our users and potential users for release in version 2.0. We believe the potential number of eventual users for PKPlus is in the thousands worldwide and that it has the potential to eventually become a significant revenue producer.

  

PKPlus version 2.0 was released in February 2018. This new version incorporates a wide variety of requested features from current users as well as evaluators of version 1.0, including:

 

  · Ability to edit input data prior to incorporating it into a Project database
  · 21 CFR Part 11 compliance for audit trail and validation
  · Validation data sets included
  · Compartmental multi-dose simulations
  · Command-line capability for rapid validation after installation on customers’ computers and for batch processing
  · Nonparametric superposition for analysis of multiple-dose pharmacokinetics
  · New statistics graphical outputs
  · Ability to save templates for various types of analyses – reduces time required when working with new datasets

 

ADMET Predictor™

ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) Predictor is a chemistry-based computer program that takes molecular structures (i.e., drawings of molecules represented in various formats) as inputs and predicts approximately 150 different properties for them at an average rate of over 100,000 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 software.

 

ADMET Predictor has enjoyed top-ranked for predictive accuracy in multiple peer-reviewed, independent comparison studies for many years, while generating its results at a very high throughput rate. Although the state of the art of this type of software does not enable identifying the best molecule in a series, it does allow early screening of molecules that are highly likely to fail as potential drug candidates (i.e., the worst molecules, which is typically the majority of a virtual chemical library) before synthesizing and testing them. Thus, millions of virtual compounds can be created and screened in a day, compared to potentially months or years of work to actually synthesize and test a much smaller number of actual compounds.

 

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. Pharmaceutical companies expend substantial time and money conducting a wide variety of experiments on new molecules each year, generating large databases of experimental data. Using this proprietary data to build predictive models can provide a second return on their investment; however, model building has traditionally been a difficult and tedious activity performed by specialists. The automation in ADMET Modeler makes it easy for a scientist to create very powerful machine-learning/AI models with minimal training.

 

 

 

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We released version 8.1 of ADMET Predictor in January 2017. This release included:

 

  · both 64-bit and 32-bit executables, making it possible to handle larger data sets
  · optimization of spreadsheet and model-building functions to improve efficiency
  · streamlined and much more efficient model-building in ADMET Modeler using our proprietary machine-learning engine
  · combinatorial substituent and scaffold replacement operations in the MedChem Studio Module
  · new in silico Ames tests to produce reliable confidence predictions that are more broadly applicable
  · our proprietary ADMET Risk™ scores accessible graphically in histograms

  

Version 8.5 was released in November 2017, adding:

 

  · a new Simulation Module to predict absorption and bioavailability for libraries of molecules from their structure
  · ability to optimize doses to achieve desired steady-state concentrations
  · new property models for rat fraction unbound in plasma, blood/plasma concentration ratio, and metabolism by certain enzymes
  · all MedChem Studio features now available through the same graphical user interface as ADMET Predictor
  · new synthetic difficulty model
  · improved visualization
  · multithreading and other speed enhancements

 

Version 9.0 was released in June 2018, adding:

 

·Additional pharmacokinetic (PK) endpoint predictions included with the High-Throughput Pharmacokinetics (HTPK) Simulation Module
·New artificial intelligence (machine-learning) models to predict major clearance mechanisms
·Novel DELTA Model™ approach extends model coverage space adding client data through the ADMET Modeler Module
·Multi-class classification models can now be built using our advanced artificial neural network ensemble (ANNE) methodology
·Intuitive graphical display of Biopharmaceutical Classification System (BCS) and Developability Classification System (DCS)
·Rebuilt most classification models to improve their confidence estimates
·New functionality for easily generating and visualizing fingerprints within the MedChem Studio Module

 

We have made significant investments in two key areas with version 9: improving integration of our top-ranked ADMET Predictor and GastroPlus models to leverage our novel ‘Discovery PBPK’ approaches for chemists, and further enhancing our best-in-class AI engine to assist with drug discovery. Recent publications from a large pharmaceutical company describing how they have leveraged our ‘Discovery PBPK’ methods to guide lead optimization illustrate how our unique offerings provide substantial value in this space.

 

Potential new markets for artificial intelligence (machine learning)

We are currently investigating applications of our sophisticated artificial intelligence (machine-learning) engine outside of our normal pharmaceutical markets. To date, we have conducted several proof-of-concept studies including: (1) predicting missile aerodynamic force and moment coefficients as a function of missile geometry, Mach number, and angle of attack, (2) classifying/identifying missiles and other objects from radar tracking data, (3) mapping jet engine compressor performance to predict when maintenance might be required, and (4) classifying patients as healthy or experiencing some disease state or genetic disorder evidenced by magnetic resonance imaging (MRI) of the brain. Other potential applications for this modeling engine have also been identified; however, our focus to date has been primarily in these areas.

 

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.

 

 

 

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MedChem Designer™

MedChem Designer was launched in 2011. It 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 both MedChem Studio and 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 and MedChem Studio, and because most other existing molecule-drawing programs are also provided for free. 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. With a paid ADMET Predictor license, the chemist would see the entire approximately 150 predictions that are available. Over 26,000 copies of MedChem Designer have been downloaded by scientists around the world to date.

  

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. Researchers can also click on an icon to generate the likely metabolites of a molecule and then predict all of the properties of those metabolites from ADMET Predictor, including each of their ADMET Risk scores. This is important because a metabolite of a molecule can be therapeutically beneficial (or harmful) even though the parent molecule is not.

 

Our proprietary ADMET Risk score provides a single number that tells the chemist how many default threshold values for various predicted properties were crossed (or violated) by each structure. Thus, in a single number, the chemist can instantly compare the effects of different structural changes in many dimensions. The ideal score is zero; however, a low score greater than zero might be acceptable, depending on what property(s) caused the points to be assigned. If the number is too high (greater than 5 or 6), the molecule is not likely to be successful as a drug. The default rules can be modified and new rules can be added by the user to include any desired rule set based on any combination of calculated molecular descriptors, predicted properties, and user inputs. As chemists attempt to modify structures to improve one property, they often cause others to become unacceptable. Without ADMET Risk, the chemist would have to individually examine many key properties for each new molecule (and its metabolites) to determine whether any of them became unacceptable as a result of changing the structure.

 

MedChem Studio™

MedChem Studio has been integrated into the ADMET Predictor platform but can still be licensed separately without requiring a license for ADMET Predictor. MedChem Studio is a powerful software tool that is used both for data mining and for de novo design of new molecules. In its data-mining role, MedChem Studio facilitates searching large chemical libraries to find molecules that contain identified substructures, and it enables rapid identification of clusters (classes) of molecules that share common substructures. We have now merged MedChem Studio with ADMET Predictor so that either program can be entered through the same interface, and the communication between the two programs is enhanced through the seamless integration of both technologies. We believe this will enhance the attractiveness of both ADMET Predictor and MedChem Studio to medicinal and computational chemists.

    

While MedChem Designer can be used to refine a small number of molecules, MedChem Studio can be used to create and screen (with ADMET Predictor) very large numbers of molecules down to a few promising lead candidates. MedChem Studio has features that enable it to generate new molecular structures using a variety of de novo design methods. When MedChem Studio is used with ADMET Predictor and MedChem Designer (the combination of which we refer to as our ADMET Design Suite), we believe the programs provide an unmatched capability for chemists to search through large libraries of compounds that have undergone high-throughput screening experiments to find the most promising classes (groups of molecules with a large common part of their structures) and molecules that are active against a particular target. In addition, MedChem Studio can take an interesting (but not acceptable) molecule and, using a variety of design algorithms, quickly generate many thousands to millions of high quality analogs (similar new molecules). These molecules can then be screened using ADMET Predictor to find molecules that are predicted to be both active against the target and acceptable in a variety of ADMET properties. We demonstrated the power of the ADMET Design Suite during two NCE (new chemical entity) projects wherein we designed lead molecules to inhibit the growth of the plasmodium falciparum malaria parasite in one study, and lead molecules that were able to inhibit two targets at the same time: COX-1 and COX-2. In each case, we announced ahead of time that we were attempting to do this, and we reported the results when the projects were complete. Every molecule we designed and had synthesized hit their targets in both projects, clearly demonstrating the power of the ADMET Design Suite.

  

 

 

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KIWI™

Drug development programs rely increasingly on modeling and simulation analyses to support decision-making and submissions to regulatory agencies. To ensure high-quality analyses, organizations must not only apply high-quality science, but must also be able to support the science by being able to validate the results. KIWI is a cloud-based web application that was developed to efficiently organize, process, maintain, and communicate the volume of data and results generated by pharmacologists and scientists over the duration of a drug development program. The validated workflow and tools within KIWI promote traceability and reproducibility of results.

 

The pharmaceutical industry has been rapidly adopting cloud technology as a solution to ever-expanding computer processing needs. Leveraging our 20-plus years of experience in providing an architecture supporting modeling and simulation efforts, we have developed KIWI as a secure, validated, enterprise-scale environment, enabling global teams to collaborate on model-based decision making. KIWI has proven to be a valuable platform for encouraging interdisciplinary discussions about the model development process and interpretation of results. We continue to receive positive feedback about the functionality implemented in KIWI and the value of the approach we have taken to harness cloud technology. We continue to improve functionality and collaboration within the KIWI platform, and we expect the licensing fee will be a source of recurring revenue for further development and growth. KIWI Version 1.3 was released in May 2015. This version of KIWI provided our user community with access to new features that accelerated completion of modeling projects by decreasing run times and facilitating the comparison and exporting of results across models. These features included dynamic comparisons of model parameter estimates and diagnostic plots, export of model run records for regulatory submissions, and accelerated infrastructure with the upgrade to the latest versions of NONMEM® and Perl-speaks-NONMEM running in a 64-bit Linux environment.

  

KIWI Version 1.6 was released in September 2016. This version introduced major enhancements in the functionality of visualization tools offered by the platform. These enhancements include simplifying the creation of plots and comparing them across multiple models, thus accelerating the model refinement process. In addition, analysts could now conveniently copy visualization preferences across projects, improving consistency and facilitating collaboration and communication with clients and colleagues.

 

KIWI 2 was released in December 2017. This latest version introduces a repository within the KIWI Cloud service to facilitate the management and organization of data and documents used and produced to support the modeling and simulation analyses used, in part, to submit new drug applications. The user interface provides a predefined directory as a default that can be customized, allows file version control, and provides a comprehensive roles and permissions structure to enhance collaboration among a community of users. As part of this initiative, an enhanced authentication framework foundation was included to provide the ability for clients to customize authentication rules according to their internal regulatory policies and procedures. In addition, since it can take hundreds of models to create one final model, an automated diagnostics dashboard has been added that visually displays the results of over 10 diagnostics that are used by modelers to decide what direction to take their modeling with the potential to significantly reduce the amount of time it takes to arrive at a final model.

We continue 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. Some drugs cause temporary changes in liver function but the body soon compensates and liver function returns to normal. Other drugs cause liver function to permanently decline as they continue to be taken. The DILIsym software models a variety of interactions within the hepatocytes to determine whether a particular drug molecule interrupts normal signaling pathways in a manner to induce injury to the cells.

 

 

 

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Version 7A of the DILIsym software was released in January 2018. This version changes the software from an open-source platform to a secure executable that incorporates new proprietary code enabling tighter integration with our GastroPlus PBPK software. Securing the code is necessary to ensure that results are consistent across all users to assure regulatory agencies that the calculated results are from a validated version. Open source programs are subject to modification by the user and so each use could have a different set of calculations, so validation would not be assured. In addition, a number of important new capabilities were added:

 

  · Additional validation compounds
  · New optimization interface allowing complex fitting using genetic algorithms
  · Clinical Monitoring feature allowing dynamic clinical trials with dose alterations based on specified thresholds
  · Weight-adjusted dosing option
  · Export enhancements providing better information on simulation setup within exported Excel® file
  · MATLAB 2017b friendly – faster simulations
  · Two new SimPops
  o Combined ALT biomarker parameter variability with toxicity pathway parameters
  o Mitochondrial biogenesis parameter variability
  · Creation of custom cohorts from existing SimPops/SimCohorts
  · Updated initial conditions infrastructure allowing importing custom SimPops in compiled version
  · Update Output Table with more clinically important metrics built-in

 

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 by excess fat 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.

 

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. They have attended over 200 scientific meetings worldwide in the past four years, often speaking and presenting. We frequently conduct contracted consulting studies for large customers (including many of the top twenty pharmaceutical companies) who have particularly difficult problems and who recognize our expertise in solving them, as well as for smaller customers who prefer to have studies run by our scientists rather than to license our software and train someone to use it. The demand for our consulting services has been steadily increasing, and we have expanded our consulting teams to meet the increased workload.

 

We continue working on a five-year consulting agreement with the Bill and Melinda Gates Foundation to implement a platform for coordinating the data generated by global teams engaged in model-based drug development.

 

We currently are working with the FDA on three Research Collaboration Agreements (RCAs): the funded efforts for long-acting injectable microspheres/ocular dosing and the unfunded IVIVC effort, both described above under “GastroPlus”.

  

Pharmacometric Modeling

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 30-40 drug projects per year. Traditionally, the model-based analysis of clinical trial data was different from the modeling analysis offered by GastroPlus; 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 guide drug formulation design and dose selection. Beginning in 2014, the U.S. F.D.A and other regulatory agencies began to emphasize the need to push mechanistic PBPK modeling and simulation into clinical pharmacology, and we have seen the benefit of having our clinical pharmacology team in the Cognigen division and our scientists in our Lancaster, California (Simulations Plus) division working together to achieve this goal.

 

 

 

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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. We currently have one license agreement, with BIOVIA (formerly known as Accelrys, Inc.), a San Diego division of Dassault Systemes in France, pursuant to which a small royalty is paid to BIOVIA from revenues on each license for the Metabolite module in ADMET Predictor. This license agreement continues in perpetuity and either party has the right to terminate it.

 

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 $1,250,000 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 50 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 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 believe that this is more effective than a completely separate sales team for several reasons: (1) customers appreciate talking directly with software developers and consulting scientists who can answer a wide range of in-depth technical questions about methods and features; (2) our scientists and engineers gain an appreciation for the customer’s environment and problems; and (3) we believe the relationships we build through scientist-to-scientist contact are stronger than relationships built through salesperson-to-scientist contacts. 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.

 

 

 

 

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PRODUCTION

Our pharmaceutical software products are designed and developed by our development teams in California (Lancaster, Guerneville, San Jose, and San Diego), North Carolina (Research Triangle Park), and New York (Buffalo); team members in most cases can 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 new PKPlus software product will compete with one major and a few minor software programs; however, the capabilities and design features of PKPlus, along with more affordable licensing, are expected to generate significant interest. 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. 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, but also with the in-house development 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, and NAFLDsym software offerings are each unique in their combination of capabilities and we intend to continue to market them aggressively.

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 to effectively predict activities and ADMET-related behaviors of new drug-like compounds, (2) design new molecules with acceptable activity and ADMET properties, (3) develop and maintain a proprietary database of results of physical experiments that serve as a basis for simulated studies and empirical models, (4) continue to attract and retain a highly skilled scientific and engineering team, (5) aggressively our products and services to our global market, and (6) 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 the pharmaceutical software and services business and to explore opportunities in aerospace and general healthcare.

 

STRATEGY

Our business strategy is to do the things we need to do to promote growth both organically (i.e., by expanding our current products and services through in-house efforts) and by acquisition. We believe in the “Built to Last” approach - that the fundamental science and technologies that underlie our business units are the keys both to improving our existing products and to expanding the product line with new products that meet our various customers’ needs. We believe the continued growth of our pharmaceutical software and services business segment is the result of steadily increasing adoption of simulation and modeling software tools across the pharmaceutical industry, as well as the world-class expertise we offer as consultants to assist companies involved in the research and development of new medicines. We have received a continuing series of study contracts with pharmaceutical companies ranging from several of the largest in the world to a number of medium-sized and smaller companies in the U.S. and Europe.

  

On July 23, 2014, we signed a merger agreement with Cognigen Corporation of Buffalo, New York. The merger closed on September 2, 2014, and Cognigen became our wholly owned subsidiary. We believe the combination of Simulations Plus and Cognigen provides substantial future potential based on the complementary strengths of each of the companies.

 

 

 

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In June 2017, Simulation Plus 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. We believe the combination of Simulations Plus and DILIsym provides substantial future potential based on the complementary strengths of each of the companies. The acquisition of DILIsym positions the Company as the leading provider of Drug Induced Liver Injury (DILI) modeling and simulations software and contract research 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™.

  

It is our intent to continue to search for acquisition opportunities that are compatible with our current businesses and that are accretive, i.e., adding to both revenues and earnings.

 

In the fiscal year ended August 31, 2017 we distributed $0.20 per share in dividends to our shareholders. In November 2017, February 2018 and May 2018, we distributed a quarterly dividend of $0.06 per share. We anticipate future dividends to be $0.06 per share per quarter; however, there can be no assurances that such dividends will be distributed, or if so, whether the amounts will be more, less, or the same as expected. The Board of Directors must approve each quarterly dividend distribution and may decide to increase, decrease, or eliminate dividend distributions at any time.

  

Results of Operations

 

Comparison of Three Months Ended May 31, 2018 and 2017.

 

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
    5/31/18    5/31/17
Net revenues  $8,553    100.00%   $6,749   100.0%
Cost of revenues   2,023    23.6    1,445   21.4
Gross profit   6,530    76.4    5,304   78.6
Selling, general and administrative   2,604    30.4    1,955   29.0
Research and development   508    5.9    254   3.7
Total operating expenses   3,112    36.4    2,209   32.7
Income from operations   3,418    40.0    3,095   45.9
Other income (expense)   (21)   (0.2)   (10)  (0.2)
Income from operations before taxes   3,397    39.7    3,085   45.7
Benefit (Provision for) for income taxes   (991)   (11.6)   (1,005)  (14.9)
Net income  $2,406    28.1%   $2,080   30.8%

 

Net Revenues

Consolidated net revenues increased by 26.7% or $1.80 million to $8.55 million in the third fiscal quarter of Fiscal Year 2018 (“3QFY18”) from $6.75 million in the third fiscal quarter of Fiscal Year 2017 (“3QFY17”). Changes by division are as follows:

 

  · Lancaster: $706,000 increase, representing a 14.3% increase to $5.65 million
  · Buffalo (Cognigen): $141,000 increase, representing a 7.8% increase to $1.94 million
  · North Carolina (DILIsym): recorded revenues of $957,000. (Acquired June 1, 2017, they were not a part of the prior year numbers)

  

Consolidated software and software-related sales increased $830,000 or 17.4%, while consolidated consulting and analytical study revenues increased $974,000 or 49.1% over 3QFY17.

 

 

 

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Cost of Revenues

Consolidated cost of revenues increased by $578,000, or 40.0%, in 3QFY18 to $2.02 million from $1.44 million in 3QFY17. Labor-related cost accounted for $284,000 of this increase, a combination of increased labor count, salary increases, and bonuses at our subsidiaries based on increased earnings. Included in the increase was $167,000 of salary expense at DILIsym. Other significant increases in cost of revenues included $179,000 of direct contract expenses paid for testing at DILIsym, an increase of $41,000 of software amortization, as well as an additional $79,000 of amortization expense associated with acquired technologies associated with DILIsym’s drug-induced liver injury technologies.

 

Cost of Revenues as a percentage of revenue increase by 2.2% in 3QFY18 to 23.6% as compared to 21.4% in 3QFY17. This change comes from higher salaries and direct costs of contract studies in 3QFY18.

 

Gross Profit

Consolidated gross profit increased $1.23 million or 23.1%, to $6.53 million in 3QFY18 from $5.30 million in 3QFY17. $639,000 of this increase is from the California division, which showed an 86.6% gross margin. The Buffalo division gross profit increased $69,000 or 6.6% with gross margin of 57.5%, and DILIsym of North Carolina showed $519,000, a 54.2% gross margin.

 

Overall gross margin as a percentage of revenue decreased by 2.24% to 76.4% in 3QFY18 from 78.6% in 3QFY17.

  

Selling, General and Administrative Expenses

Selling, general, and administrative (SG&A) expenses increased $649,000, or 33.2% to $2.60 million in 3QFY18 from $1.95 million in 3QFY17. As a percent of revenues, SG&A was 30.4% for 3QFY18, compared to 29.0% in 3QFY17.

 

The major increases in SG&A expense were:

 

· Commission expense: $70,000 increased sales in international markets
· Contract labor: $53,000 made up of certain outsourced services and director fees paid
· G&A Salaries and Wages increased by $276,000; this increase is a combination of increased stock compensation costs, 401k, annual salary increases, increased head count in Lancaster and Buffalo, and first-time third-quarter salaries at DILIsym after acquisition
· Insurance Expense increased $68,000; mostly health-related medical costs due to cost increases and higher employee counts, of which $34,000 was first time costs associated with DILIsym
· Payroll tax expense increased $62,000, the effect of higher salary expense and first time costs of $31,000 associated with  DILIsym
· Professional Accounting and Audit increased $77,000; this year’s tax and internal compliance service started later in the fiscal year; as well as increased costs of a new subsidiary
· Trade show and Travel $57,000; increase in shows and trainings compared to prior year
· Amortization expense increased $53,000 due to new acquisition amortization for DILIsym intangibles

 

The major decreases in SG&A expense were:

 

· Legal fees decreased $105,000 due to a reduction in acquisition-related document review
· Recruitment & Hiring $31,000; lower hiring costs this year

 

Research and Development

Total research and development cost increased $522,000 in 3QFY18 compared to 3QFY17. In 3QFY18 we incurred approximately $993,000 of research and development cost. Of this amount, $485,000 was capitalized and $508,000 was expensed. In 3QFY17 we incurred approximately $598,000 of research and development costs. Of this amount, $344,000 was capitalized and $254,000 was expensed.

 

   

 

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Income from operations

Income from operations increased $323,000 or 34.7% in 3QFY18 compared to 3QFY17.

 

· Lancaster Increased $356,000 or 13.3%
· Buffalo Decreased $31,000 or 7.4%
· No. Carolina Recorded an operating profit of $3,000 for the quarter, their first third quarter reporting since being acquired on June 1, 2017.  

 

Provision for Income Taxes

The provision for income taxes was $991,000 for 3QFY18 compared to $1,005,000 for 3QFY17.

 

The effective rate for the quarter was 29.1% compared to 32.2% in the prior year. The change is from the effect of the new tax rates under new Federal tax laws enacted as of January 1, 2018. Federal statutory tax rates decreased from 34% to 21% as of January 1, 2018. The Company has used a blended rate for the current period to calculate current income tax expense.

 

Net Income

Net income increased by $327,000, or 15.7%, in 3QFY18 to $2.41 million from $2.08 million in 3QFY17.

 

Comparison of Nine Months Ended May 31, 2018 and 2017

 

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 
   5/31/18   5/31/17 
         
Net revenues  $22,979    100.00%   $17,872    100.0% 
Cost of revenues   5,874    25.6    4,335    24.2 
Gross profit   17,105    74.4    13,537    75.8 
Selling, general and administrative   7,352    32.0    5,767    32.3 
Research and development   1,354    5.9    953    5.3 
Total operating expenses   8,706    37.9    6,719    37.6 
Income from operations   8,399    36.5    6,818    38.2 
Other income   (100)   (0.4)   19    0.1 
Income from operations before taxes   8,298    36.1    6,837    38.3 
Benefit (Provision for) for income taxes   (701)   (3.1)   (2,200)   (12.3)
Net income  $7,597    33.1%   $4,637    25.9% 

  

Net Revenues

Consolidated net revenues increased by 28.6% or $5.11 million to $22.98 million in the first nine months of Fiscal Year 2018 “9moFY18”) from $17.87 million in the first nine months of Fiscal Year 2017 (“9moFY17”). Changes by division are as follows:

 

· Lancaster: $1,562,000 increase, representing a 12.3% increase to $14.25 million
· Buffalo (Cognigen): $534,470 increase, representing a 10.3% increase to $5.72 million
· North Carolina (DILIsym): recorded revenues of $3.01 million. (Acquired June 1, 2017, they were not a part of the prior year third quarter numbers)

 

Consolidated software and software-related sales increased $1,594,000 or 13.3%, while consolidated consulting and analytical study revenues increased $3.51 million or 59.8% over 9moFY17.

 

 

 

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Cost of Revenues

Consolidated cost of revenues increased by $1.54 million, or 35.5%, in 9moFY18 to $5.87 million from $4.33 million in 9moFY17. Labor-related cost accounted for $835,000 of this increase, a combination of increased labor count, salary increases, and bonuses at our subsidiaries based on increased earnings. Included in the increase was $288,000 of salary expenses at DILIsym. Other significant increases in cost of revenues included $88,000 of software amortization, $458,000 of direct contract expenses paid for testing at DILIsym, as well as an additional $237,000 of amortization expense associated with acquired technologies associated with DILIsym’s drug-induced liver injury technologies. Training-related expenses were down $65,000 compared to the prior year.

 

Cost of Revenues as a percentage of revenue increased by 0.6% in 9moFY18 to 25.6% as compared to 24.2% in 9moFY17.

 

Gross Profit

Consolidated gross profit increased $3.57 million or 26.4%, to $17.10 million in 9moFY18 from $13.54 million in 9moFY17. $1,360,000 of this increase is from the Lancaster division, which showed an 83.8% gross margin. The Buffalo division gross profit increased $369,000 or 12.5% with a gross margin of 58.1%, and DILIsym of North Carolina showed $1.84 million, a 61.1% gross margin.

 

Overall gross margin as a percentage of revenue decreased by 1.4% to 74.4% in 9moFY18 from 75.8% in 9moFY17.

  

Selling, General and Administrative Expenses

Selling, general, and administrative (SG&A) expenses increased $1,586,000, or 27.5% to $7.35 million in 9moFY18 from $5.77 million in 9moFY17. As a percent of revenues, SG&A was 32.0% for 9moFY18, compared to 32.3% in 9moFY17.

 

The major increases in SG&A expense were:

 

· Commissions expense: $141,000 related mainly to increased international sales
· Market expenses: $174,000 related to trade show and conference attendance
· Contract labor: $174,000 made up of outsourced services and increased Director compensation program costs
· Employee 401k expense: $59,000
· G&A Salaries and Wages increased by $439,000; this increase is a combination of increased stock compensation costs of $59,000, first time salaries of $197,000 at DILIsym after acquisition, annual salary increases and increased head count in Lancaster and Buffalo
· Insurance Expense $221,000; mostly health-related medical costs due to cost increases and higher employee counts, of which $97,000 was associated with DILIsym
· Payroll tax expense increased $174,000, the effect of higher salary expense and first time costs of $81,000 associated with DILIsym
· Professional Accounting tax and audit increased $101,000; Increased costs associated with accounting initiatives, compliance and audit for new subsidiary
· Rent: $49,000 mostly due to first time costs associated with added facilities costs at DILIsym
· Software licenses: $46,000
o Amortization expense increased $158,000 due to new acquisition amortization for DILIsym intangibles

 

The major decreases in SG&A expense were:

 

· Legal expenses decreased $228,000 due to a reduction in document review

  

Research and Development

Total research and development cost increased $1,099,000 in 9moFY18 compared to 9moFY17. In 9moFY18 we incurred approximately $2,985,000 of research and development costs, of this amount, $1,632,000 related to the development of software and was capitalized and $1,353,000 was expensed. In 9moFY17 we incurred approximately $1,880,000 of research and development costs, of this amount, $928,000 related to the development of software and was capitalized and $952,000 was expensed.

 

 

 

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Income from operations

Income from operations increased $1,580,000 or 23.2% in 9moFY18 compared to 9moFY17.

 

· Lancaster Increased $833,000 or 14.5%
· Buffalo Increased $140,000 or 13.0%
· No. Carolina Recorded operating income of $607,000, their first 9moFY18 reporting since acquisition on June 1, 2017

 

Other income (expense)

Other income was an expense of $100,000 compared to income of $19,000 in 9moFY17, a decrease of $119,000. The majority of the change comes from an imputed interest expense of $114,000 associated with acquisition-related liabilities.

 

Provision for Income Taxes

The provision for income taxes was $701,000 for 9moFY18 compared to $2.20 million for 9moFY17.

 

The decrease comes mainly the completion of an assessment of deferred taxes based on the new tax rates enacted under the Tax Cuts and Jobs Act of 2017 (the “2017 Tax Act). Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 740, Income Taxes (“ASC 740”) requires that the company recognize the effects of changes in tax laws or tax rates in the financial statements for the period in which such changes were enacted. Among other things, changes in tax laws or tax rates can affect the amount of taxes payable for the current period, as well as the amount and timing of deferred tax liabilities and deferred tax assets. Based on the assessment the Company posted a one-time tax benefit in the amount of $1,500,000 in the second fiscal quarter of 2018, the result of estimating future deferred liabilities at the lower tax rates under the newly enacted tax laws.

 

Federal statutory tax rates decreased from 34% to 21% as of January 1, 2018. The Company has used a blended rate for the current period to calculate current income tax expense since four months were in calendar year 2017 and five were in 2018 under the new tax law.

 

The effective rate for the nine months was 8.45%, compared to an expense of 32.2% in the prior year. The significant change is from the effect of the tax benefit due to the rate change applied to deferred tax liabilities.

 

Net Income

Net income increased by $2.96 million, or 60.2%, in 9moFY18 to $7.60 million from $4.64 million in 9moFY17. $1,500,000 of this increase, representing approximately 20% of the change, is from the effects of the reassessment of deferred taxes under the new rates enacted under the Tax Cuts and Jobs Act of 2017. Without the deferred tax benefit, net income increased by $1.46 million, or 31.5%.

 

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 open a revolving line of credit with a 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.

   

 

 

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

As of May 31, 2018 and August 31, 2017, we had cash and cash equivalents of $7.22 million and $6.22 million, respectively. We do not hold any investments that are exposed to market risk related to changes in interest rates, which could adversely affect the value of our assets and liabilities, and 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, 2018 and 2017, we sold $1,365,000 and $1,009,000, and $2,937,000 and $2,284,000, 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, 2018. 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, 2018, 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.

    

 

 

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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, 2017, 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.

 

  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

  

 

 

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  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.
10.10* (†)   Employment Agreement by and between the Company and Shawn O’Connor, dated as of June 25, 2018.
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.

 

 

 

 

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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 10, 2018.

 

    Simulations Plus, Inc.
     
     
Date: July 10, 2018 By: /s/ John R Kneisel                   
    John R. Kneisel

 

    Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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