SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
|☒|| Quarterly Report Pursuant to Section 13 or 15(d) of the Security Exchange Act of 1934 for the quarterly |
period ended November 30, 2015
|☐|| 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)
|(State or other jurisdiction of Incorporation or Organization)||(I.R.S. Employer identification No.)|
42505 10 th Street West
Lancaster, CA 93534-7059
(Address of principal executive offices including zip code)
(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, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer," and "smaller reporting 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|
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 $0.001 per share, as of January 14, 2016 was 16,966,001 and no shares of preferred stock were outstanding.
Simulations Plus, Inc.
For the Quarterly Period Ended November 30, 2015
Table of Contents
PART I. FINANCIAL INFORMATION
|Item 1.||Financial Statements (Unaudited)||2|
|Consolidated Condensed Balance Sheet at November 30, 2015 (unaudited) and August 31, 2015 (audited)||2|
|Consolidated Condensed Statements of Operations for the three months ended November 30, 2015 and 2014 (unaudited)||3|
|Consolidated Condensed Statements of Cash Flows for the three months ended November 30, 2015 and 2014 (unaudited)||4|
|Notes to Consolidated Condensed Financial Statements (unaudited)||5|
|Item 2.||Management's Discussion and Analysis or Plan of Operations||17|
|Results of Operations||27|
|Liquidity and Capital Resources||28|
|Item 3.||Quantitative and Qualitative Disclosures about Market Risk||29|
|Item 4.||Controls and Procedures||29|
|PART II. OTHER INFORMATION|
|Item 1.||Legal Proceedings||30|
|Item 1A||Risk Factors||30|
|Item 2.||Changes in Securities||30|
|Item 3.||Defaults upon Senior Securities||30|
|Item 4.||Mine Safety Disclosures||30|
|Item 5.||Other Information||30|
SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|November 30,||August 31,|
|Cash and cash equivalents||$||7,154,513||$||8,551,275|
|Accounts receivable, net of allowance for doubtful accounts of $0||4,042,436||1,593,707|
|Revenues in excess of billings||742,939||795,125|
|Prepaid expenses and other current assets||263,062||381,718|
|Deferred income taxes||161,431||210,972|
|Total current assets||12,364,381||11,532,797|
|Capitalized computer software development costs, net of accumulated amortization of $7,879,689 and $7,632,421||3,818,371||3,798,339|
|Property and equipment, net (note 3)||364,499||413,510|
|Intellectual property, net of accumulated amortization of $953,125 and $801,250||5,121,875||5,273,750|
|Other intangible assets net of accumulated amortization of $184,375 and $147,500||1,465,625||1,502,500|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accrued payroll and other expenses||501,935||429,580|
|Accrued bonuses to officer||30,250||121,000|
|Income taxes payable||385,095||43,602|
|Other current liabilities||19,859||19,859|
|Current portion - Contracts payable (note 4)||2,604,404||2,604,404|
|Billings in excess of revenues||211,718||106,534|
|Total current liabilities||3,896,728||3,613,331|
|Deferred income taxes||3,123,517||3,190,419|
|Payments due under Contracts payable (note 4)||1,000,000||1,000,000|
|Other long-term liabilities||3,309||8,274|
|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, $0.001 par value 50,000,000 shares authorized 16,996,001 and 16,943,001 shares issued and outstanding||5,467||5,414|
|Additional paid-in capital||9,859,889||9,714,290|
|Total shareholders' equity||$||19,934,527||$||19,532,202|
|Total liabilities and shareholders' equity||$||27,958,081||$||27,344,226|
The accompanying notes are an integral part of these financial statements.
SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED Statements of Operations
For the three months ended November 30,
|Three months ended|
|Cost of revenues||1,083,347||997,734|
|Selling, general, and administrative||1,676,433||2,079,169|
|Research and development||351,307||259,912|
|Total operating expenses||2,027,740||2,339,081|
|Income from operations||1,727,533||749,377|
|Other income (expense)|
|Gain (loss) on currency exchange||(14,895||)||(7,790||)|
|Total other income (expense)||(10,428||)||(3,198||)|
|Income from operations before provision for income taxes||1,717,105||746,179|
|Provision for income taxes||(610,632||)||(217,275||)|
|Earnings per share|
|Weighted-average common shares outstanding|
The accompanying notes are an integral part of these financial statements.
SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED Statements of Cash Flows
For the three months ended November 30,
|Cash flows from operating activities|
|Adjustments to reconcile net income to net cash provided by operating activities|
|Depreciation and amortization of property and equipment||50,218||93,036|
|Amortization of capitalized computer software development costs||247,268||213,290|
|Amortization of Intellectual Property||188,750||151,875|
|Deferred income taxes||(17,361||)||32,370|
|(Increase) decrease in|
|Revenues in excess of billings||52,186||(177,880||)|
|Prepaid income taxes||–||122,231|
|Prepaid expenses and other assets||118,656||12,788|
|Increase (decrease) in|
|Accrued payroll and other expenses||72,355||(112,413||)|
|Billings in excess of revenues||105,184||(216,715||)|
|Accrued income taxes||341,493||–|
|Net cash provided by (used in) operating activities||(360,145||)||226,793|
|Cash flows from investing activities|
|Purchases of property and equipment||(1,207||)||(20,944||)|
|Cash used to purchase Cognigen||–||(2,080,000||)|
|Cash received in acquisition||–||190,184|
|Capitalized computer software development costs||(267,300||)||(297,729||)|
|Net cash provided by (used in) investing activities||(268,507||)||(2,208,489||)|
|Cash flows from financing activities|
|Payment of Dividends||(849,800||)||(842,056||)|
|Proceeds from the exercise of stock options||81,690||–|
|Net cash (used in) financing activities of continuing operations||(768,110||)||(842,056||)|
|Net increase (decrease) in cash and cash equivalents||(1,396,762||)||(2,823,752||)|
|Cash and cash equivalents, beginning of year||8,551,275||8,614,929|
|Cash and cash equivalents, end of period||$||7,154,513||$||5,791,177|
|Supplemental disclosures of cash flow information|
|Income taxes paid||$||285,500||$||3,232|
|Non-Cash Investing and Financing Activities|
|Stock issued for acquisiton of Cognigen Corporation||$||–||$||3,277,170|
|Creation of contract liability for acquisition of Cognigen Corporation||$||–||$||1,854,404|
The accompanying notes are an integral part of these financial statements.
Simulations Plus, Inc.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
November 30, 2015 and 2014
Note 1: GENERAL
This report on Form 10-Q for the quarter ended November 30, 2015, should be read in conjunction with the Company's annual report on Form 10-K for the year ended August 31, 2015, filed with the Securities and Exchange Commission ("SEC") on November 20, 2015. As contemplated by the SEC under Article 8 of Regulation S-X, the accompanying consolidated financial statements and footnotes have been condensed and therefore do not contain all disclosures required by generally accepted accounting principles. The interim financial data are unaudited; however, in the opinion of Simulations Plus, Inc. ("we", "our", "us"), the interim data includes all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the results for the interim periods. Results for interim periods are not necessarily indicative of those to be expected for the full year.
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. (collectively, "Company", "we", "us", "our"), pursuant to the terms of that certain Agreement and Plan of Merger, dated as of July 23, 2014, by and between Simulations Plus and Cognigen (the "Merger Agreement").
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 and, as of September 2, 2014, its wholly-owned subsidiary, Cognigen. All significant intercompany accounts and transactions are eliminated in consolidation.
Our condensed 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.
We recognize revenues related to software licenses and software maintenance in accordance with Financial Accounting Standard Board ("FASB") Accounting Standard 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.
As a byproduct of ongoing improvements and upgrades for the new programs and new modules of software, some modifications are provided to customers who have already purchased software licenses 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.
We recognize revenue from collaboration research and revenue from grants equally 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, we consider all highly liquid investments purchased with original maturities of three months or less to be cash equivalents.
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 its customers deteriorated, whether due to customer-specific or general economic issues, an increase in the allowance may be made. Accounts receivable are written off when all collection attempts have failed.
Capitalized Computer Software Development Costs
Software development costs are capitalized in accordance with ASC 985-20, "Costs of Software to Be Sold, Leased, or Marketed" . Capitalization of software development costs begins upon the establishment of technological feasibility and is discontinued when the product is available for sale.
The establishment of technological feasibility and the ongoing assessment for recoverability of capitalized software development costs require considerable judgment by management with respect to certain external factors including, but not limited to, technological feasibility, anticipated future gross revenues, estimated economic life, and changes in software and hardware technologies. Capitalized software development costs are comprised primarily of salaries and direct payroll-related costs and the purchase of existing software to be used in our software products.
Amortization of capitalized software development costs is calculated on a product-by-product basis on the straight-line method over the estimated economic life of the products (not to exceed five years, although all of our current software products have already been on the market for 7-15 years except for our newest MedChem Designer™ program, and we do not foresee an end-of-life for any of them at this point). Amortization of software development costs amounted to $247,268 and $213,290 for the three months ended November 30, 2015 and 2014, 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:
|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
Goodwill and indefinite-lived assets are not amortized, but are evaluated for impairment annually or when indicators of a potential impairment are present. Our impairment testing of goodwill is performed separately from our impairment testing of indefinite-lived intangibles. The annual evaluation for impairment of goodwill and indefinite-lived intangibles is based on valuation models that incorporate assumptions and internal projections of expected future cash flows and operating plans.
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.|
The following table summarizes fair value measurements by level at November 30, 2015 for assets and liabilities measured at fair value on a recurring basis:
|Level I||Level II||Level III||Total|
|Cash and cash equivalents||$||7,154,513||$||–||$||–||$||7,154,513|
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.
Research and Development Costs
Research and development costs are charged to expense as incurred until technological feasibility has been established. These costs consist primarily of salaries and direct payroll-related costs. It also includes purchased software and databases that were developed by other companies and incorporated into, or used in the development of, our final products.
We utilize FASB 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.
On February 28, 2012, we bought out the 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 the fiscal quarters ended November 30, 2015 and 2014 was $1,875 and $1,875, respectively. Accumulated amortization as of November 30, 2015 and 2014 was $28,125 and $20,625, respectively.
On May 15, 2014, we bought out a royalty agreement with TSRL, Inc. of Ann Arbor, Michigan. The cost of $6,000,000 is being amortized over 10 years under the straight-line method. Amortization expense for the periods ended November 30, 2015 and 2014 was $150,000. Accumulated amortization as of November 30, 2015 and August 31, 2015 was $925,000 and $775,000, respectively. (See Note 4.)
Total amortization expense for intellectual property agreements for the three months ended was $151,875 and $151,875, respectively. Accumulated amortization as of November 30, 2015 and August 31, 2015 was $953,125 and $801,250, respectively.
The Company acquired certain intangible assets as part of the acquisition of Cognigen Corporation on September 2, 2014. The following table summarizes those intangible assets as of November 30, 2015:
|Amortization Period||Acquisition Value||Accumulated Amortization||Net book value|
|Customer relationships||Straight line 8 years||$||1,100,000||$||171,875||$||928,125|
|Covenants not to compete||Straight line 5 years||50,000||12,500||37,500|
Amortization expense for each of the three months ended November 30, 2015 and 2014 was $36,875. According to policy in addition to normal amortization, these assets are tested for impairment as needed.
Earnings per Share
We report earnings per share in accordance with FASB ASC 260-10. Basic earnings per share is computed by dividing income available to common shareholders by the weighted-average number of common shares available. Diluted earnings per share is computed similar to basic earnings per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. The components of basic and diluted earnings per share for the three months ended November 30, 2015 and 2014 were as follows:
|Net income attributable to common shareholders||$||1,106,473||$||528,904|
|Weighted-average number of common shares outstanding during the 3 months of FY15 & FY14||16,966,089||16,830,319|
|Dilutive effect of stock options||288,979||267,539|
|Common stock and common stock equivalents used for diluted earnings per share||17,255,068||17,097,858|
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, amortized on a straight-line basis over the options' vesting period. Stock-based compensation was $63,962 and $65,799 for the three months ended November 30, 2015 and 2014, respectively, and is included in the condensed statements of operations as Selling, General and Administration (SG&A), and Research and Development expense.
Recently Issued Accounting Pronouncements
In July 2013, the FASB issued ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists , which eliminates diversity in practice for the presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss or a tax credit carryforward is available to reduce the taxable income or tax payable that would result from disallowance of a tax position. ASU 2013-11 affects only the presentation of such amounts in an entity's balance sheet and is effective for fiscal years beginning after December 15, 2013 and interim periods within those years. Early adoption is permitted. We are evaluating the impact, if any, of the adoption of ASU 2013-11 on our balance sheet.
In May 2014, FASB issued ASU No. 2014-09, Revenue from Contracts with Customers ("ASU No. 2014-09"). The standard will eliminate the transaction- and industry-specific revenue recognition guidance under current 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.
Note 3: Property and Equipment
Property and equipment as of November 30, 2015 consisted of the following:
|Furniture and fixtures||123,235|
|Less: Accumulated depreciation and amortization||(514,624||)|
|Net Book Value||$||364,499|
Note 4: CONTRACTS PAYABLE
Pursuant to the termination and non-assertion agreement with TSRL, the Company agreed to pay TSRL total consideration of $6.0 million. The Company paid $3.5 million on May 20, 2014, comprised of cash in the amount of $2.5 million and the issuance of $1 million worth of the Company's common stock - 164,745 shares of the Company's common stock based upon the April 25, 2014 closing price per share of $6.07(See note 2). According to the contract, the Company paid $750,000 to TSRL in April 2015 and will pay TSRL an additional $1,750,000 within the next two-year period. The remaining payments scheduled, by year, are below.
Cognigen Acquisition Liability-Related Party
On September 2, 2014, the Company acquired Cognigen Corporation. As part of the above-discussed consideration payable to the former shareholders of Cognigen, the Company agreed that within three business days following the two-year anniversary of July 23, 2014 (the date of the Merger Agreement) and subject to any offsets, the Company will pay the former shareholders of Cognigen a total of $1,854,404, comprised of $720,000 of cash and the issuance of 170,014 shares of the Company's stock. The former shareholders of Cognigen are currently employed by the consolidated Company, one of whom serves as the President.
Future payments under the Agreements, which are non-interest-bearing, are due as follows:
|Twelve-month Period ending November 30||TSRL||Cognigen Acquisition Liability||Total|
|Less current portion||(750,000||)||(1,854,404||)||(2,604,404||)|
|contracts payable, net of current portion||$||1,000,000||$||0||$||1,000,000|
Note 5: COMMITMENTS AND CONTINGENCIES
Effective September 1, 2014, the Company entered into an Employment Agreement with Walter S. Woltosz to serve as Chief Executive Officer of the Company (the "Woltosz Employment Agreement"). The Woltosz Employment Agreement had a one-year term. Under the terms of the Woltosz Employment Agreement, Mr. Woltosz was required to devote a minimum of 60% of his productive time to the position of Chief Executive Officer of the Company. He received annual compensation of $180,000, was eligible to receive stock options to purchase up to 12,000 shares of the Company's common stock under the 2007 Simulations Plus, Inc. Stock Option Plan, as determined by the Company's Board of Directors, and was to be paid an annual performance bonus of up to 5% of the Company's net income before taxes, not to exceed $36,000. A copy of the Woltosz Employment Agreement was filed as an attachment to the 8-K filed with the Securities and Exchange Commission on September 4, 2014. On July 9, 2015, the Company renewed this employment agreement for another year on the same terms as the September 2014 agreement. A copy of the agreement was filed as an attachment to the 8-K filed with the Securities and Exchange Commission on July 15, 2015. Mr. Woltosz' bonuses under these agreements were paid in September following each agreement's term.
On September 2, 2014, Thaddeus H. Grasela, Jr., Ph.D., was appointed President of the Company, and the Company has entered into an Employment Agreement with Dr. Grasela (the "Grasela Employment Agreement"), which has a three-year term. Pursuant to the Grasela Employment Agreement, Dr. Grasela will receive an annual base salary of $250,000, will be eligible to receive stock options to purchase shares of the Company's common stock under the 2007 Simulations Plus, Inc. Stock Option Plan, as determined by the Company's Board of Directors, and will be eligible to receive an annual performance bonus in an amount not to exceed 10% of base salary to be determined by the Compensation Committee of the Company's Board of Directors. On September 1, 2015 the Compensation Committee awarded a $25,000 performance bonus to Dr. Grasela. This expense was accrued as an expense as of August 31, 2015. This bonus was paid in September 2015.
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. Under this royalty agreement for the three months ended November 30, 2015 and 2014, we incurred royalty expense of $15,550 and $10,165, respectively.
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. We file income tax returns with the IRS and various state jurisdictions and India. Our federal income tax returns for fiscal year 2011 thru 2014 are open for audit, and our state tax returns for fiscal year 2010 through 2014 remain open for audit. In addition our California tax return for the fiscal year 2007 and fiscal year 2008 remains open with regard to research and development tax credits as a result of a previous audit for which we received a letter from the California Franchise Tax Board stating that an audit will not be conducted for those years at this time; however it may be subject to future audit. In 2015 the Company was informed that the IRS will be auditing the Company's tax return for 2014. The audit was started in October 2015 and has not been completed. The Company does not believe that this examination by the IRS will result in a significant change to our financial position or results of operations.
Except as described below, we are not a party to any legal proceedings and are not aware of any pending legal proceedings of any kind.
In June 2014, the Company was served with a complaint in a civil action entitled Sherri Winslow v. Incredible Adventures, Inc., et al. (Los Angeles Superior Court Case No. BC545789) alleging wrongful death and seeking unspecified damages arising out of a May 18, 2012 plane crash in the State of Nevada. The Company's Chief Executive Officer owns the subject aircraft and is also a named defendant. The complaint alleged that the Company was the owner of the subject aircraft. The Company denied all material allegations against it, including that it owns or has ever owned any interest in the subject aircraft. On November 25, 2014, the plaintiff and the Company signed a stipulation of dismissal pursuant to which the plaintiff agreed to dismiss the Company without prejudice. The Company planned to prepare a dismissal with prejudice to be signed on behalf of the plaintiff in the event the plaintiff did not discover evidence during a nine-month period to and including August 31, 2015, that justified bringing the Company back into the litigation. The Company did not receive notification of any such discovery and is in the process of preparing documents for the plaintiff's final dismissal with prejudice.
Note 6: SHAREHOLDERS' EQUITY
The Company's Board of Directors declared cash dividends during fiscal years 2016 and 2015. The details of the dividends paid are in the following tables:
|Record Date||Distribution Date||Number of Shares Outstanding on Record Date||Dividend per Share||Total Amount|
|Record Date||Distribution Date||Number of Shares Outstanding on Record Date||Dividend per Share||Total Amount|
Stock Option Plan
In September 1996, the Board of Directors adopted, and the shareholders approved, the 1996 Stock Option Plan (the "Option Plan") under which a total of 1,000,000 shares of common stock had been reserved for issuance. In March 1999, the shareholders approved an increase in the number of shares that may be granted under the Option Plan to 2,000,000. In February 2000, the shareholders approved an increase in the number of shares that may be granted under the Option Plan to 4,000,000. In December 2000, the shareholders approved an increase in the number of shares that may be granted under the Option Plan to 5,000,000. Furthermore, in February 2005, the shareholders approved an additional 1,000,000 shares, resulting in the total number of shares that may be granted under the Option Plan to 6,000,000. The 1996 Stock Option Plan terminated in September 2006 by its term.
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.
Qualified Incentive Stock Options (Qualified ISO)
As of November 30, 2015, employees hold Qualified ISO to purchase 560,800 shares of common stock at exercise prices ranging from $1.00 to $7.10, which were granted prior to November 30, 2015.
|Transactions in FY16||Number of Options|| Weighted-Average Exercise Price|
|Weighted-Average Remaining Contractual Life|
|Outstanding, August 31, 2015||621,000||$||5.01||6.10|
|Outstanding, November 30, 2015||560,800||$||5.31||6.52|
|Exercisable, November 30, 2015||244,160||$||3.45||4.32|
Non-Qualified Stock Options (Non-Qualified ISO)
As of November 30, 2015, the outside members of the Board of Directors hold options to purchase 49,350 shares of common stock at exercise prices ranging from $1.67 to $6.75, which were granted prior to November 30, 2015.
|Transactions in FY16||Number of Options|
Weighted-Average Exercise Price
|Weighted-Average Remaining Contractual Life|
|Outstanding, August 31, 2015||49,350||$||5.52||7.78|
|Outstanding, November 30, 2015||49,350||$||5.52||7.50|
|Exercisable, November 30, 2015||27,200||$||4.70||6.06|
The weighted-average remaining contractual life of options outstanding issued under the Plan, both Qualified ISO and Non-Qualified SO, was 6.60 years at November 30, 2015. The exercise prices for the options outstanding at November 30, 2015 ranged from $1.00 to $7.10, and the information relating to these options is as follows:
|Exercise Price||Awards Outstanding||Awards Exercisable|
|Low||High||Quantity||Weighted Average Remaining Contractual Life||Weighted Average Exercise Price||Quantity||Weighted Average Remaining Contractual Life||Weighted Average Exercise Price|
|$||1.00||$||1.50||120,000||2.71 years||$||1.03||120,500||2.71 years||$||1.03|
|$||1.51||$||3.00||3,600||4.44 years||$||2.20||3,600||4.44 years||$||2.20|
|$||3.01||$||4.50||31,000||3.50 years||$||3.33||31,000||3.50 years||$||3.33|
|$||4.51||$||6.00||74,000||3.41 years||$||5.48||41,600||3.46 years||$||5.42|
|$||6.01||$||7.10||381,050||8.72 years||$||6.85||74,660||8.37 years||$||6.83|
|610,150||6.60 years||$||5.33||271,360||4.49 years||$||3.58|
Note 7: RELATED PARTY TRANSACTIONS
As of November 30, 2015, included in bonus expenses to officers was $30,250, of which $15,000 was accrued bonus representing an estimated quarterly amount of bonus payable to the Corporate Secretary, Virginia Woltosz, as part of the terms of the sale of Words+ to Simulations Plus in 1996, and $15,250 accrued bonus representing an estimated quarterly amount of bonuses payable to our President, Thaddeus Grasela, and our Chief Executive Officer, Walter Woltosz, as part of their current employment agreements.
NOTE 8: CONCENTRATIONS AND UNCERTAINTIES
Revenue concentration shows that International sales accounted for 45.9% and 39% of net sales for the three months ended November 30, 2015 and 2014, respectively. The top four customers accounted for 11%, 9% (a dealer account in Japan representing over 40 customers), 6%, and 6% of net sales during the three months ended November 30, 2015. The top five customers accounted for 16%, 12% (a dealer account in Japan representing over 40 customers), 10%, 10%, and 9% of net sales during the three months ended November 30, 2014.
Accounts receivable concentration shows that four customers comprised 16%, 13%, 8%, and 8% (a dealer account in Japan representing over 40 customers) of accounts receivable at November 30, 2015. Accounts receivable concentration shows that five customers comprised 16%, 12% (a dealer account in Japan representing over 40 customers), 10%, 10%, and 9% of accounts receivable at November 30, 2014.
We operate in the computer software industry, which is highly competitive and changes rapidly. Our operating results could be significantly affected by our ability to develop new products and find new distribution channels for new and existing products.
The majority of our customers are in the pharmaceutical industry. Although past consolidation and downsizing in the pharmaceutical industry has not negatively impacted our sales, future consolidation and downsizing could have an impact on our revenues and earnings going forward.
Note 9: SEGMENT AND Geographic Reporting
We account for segments and geographic revenues in accordance with guidance issued by the FASB. Our reportable segments are strategic business units that offer different products and services.
Results for each segment and consolidated results are as follows for the three months ended November 30, 2015 and (in thousands):
|November 30, 2015|
|Income (loss) from operations||1,424||304||1,728|
|Capitalized software costs||223||44||267|
|Depreciation and amortization||395||91||486|
|November 30, 2014|
|Income (loss) from operations||686||63||749|
|Capitalized software costs||274||24||298|
|Depreciation and amortization||367||91||458|
In addition, the Company allocates revenues to geographic areas based on the locations of its customers. Geographical revenues for the three months ended November 30, 2015 and 2014 were as follows (in thousands):
|November 30, 2015|
|North America||Europe||Asia||South America||Total|
|November 30, 2014|
|North America||Europe||Asia||South America||Total|
Note 10: EMPLOYEE BENEFIT PLAN
We maintain a 401(K) Plan for all eligible employees, and we make matching contributions equal to 100% of the employee's elective deferral, not to exceed 4% of total employee compensation. We can also elect to make a profit-sharing contribution. Our contributions to this Plan amounted to $55,889 and $57,327 for the three months ended November 30, 2015 and 2014, respectively.
Item 2. Management's Discussion and Analysis or Plan of Operations
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.
The Company is a premier developer of groundbreaking drug discovery and development simulation and modeling software. Our software is licensed to major pharmaceutical, biotechnology, agrochemical, and food industry companies and to regulatory agencies worldwide for use in the conduct of model-based drug development and the study of environmental toxicants. We also provide consulting services ranging from early drug discovery through preclinical and clinical trial data analysis and regulatory submissions. Recently, we have been exploring the application of some of our advanced machine-learning technologies for problems in aerospace and healthcare outside of our traditional markets. The Company is headquartered in Southern California, with offices in Buffalo, New York. Our common stock trades on the NASDAQ Capital Market under the symbol "SLP."
We are 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 R&D productivity.
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 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, computer science, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetics (PBPK) modeling and simulation.
We generate revenue by delivering relevant, cost-effective software, as well as creative and insightful consulting services. Pharmaceutical and biotechnology companies use our software programs and scientific knowledge to guide discovery, 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, develop generic dosage forms, optimize clinical trial designs, and simulate outcomes in special populations, such as the elderly and pediatric patients.
We currently offer seven software products for pharmaceutical research and development: three simulation programs that provide time-dependent results based on solving large sets of differential equations: GastroPlus™, DDDPlus™, and MembranePlus™; 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™); and one program that supports data analysis and reporting through our proprietary secure cloud called KIWI™. During this reporting period, we announced the upcoming release of a new software product called PKPlus™ for noncompartmental and compartmental pharmacokinetic analysis and reporting, which is further described below.
Our flagship product and currently our largest source of revenue is GastroPlus. GastroPlus simulates the absorption, pharmacokinetics, and pharmacodynamics of drugs administered to humans and animals, and is currently the most widely used software of its type in 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. The U.S. FDA recently added 50 additional GastroPlus licenses to the 20 it already had, bringing the total to 70. 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 is 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 Europe, our participation in this project is at our own expense, while other members are compensated for their work; however, we are 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 enables us to benefit from, and to contribute to, advancing the prediction of human oral bioavailability from preclinical data, and ensures that we are in front of the audience of member pharmaceutical companies and regulatory agencies.
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 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 receive up to $200,000 per year. This RCA may be renewed for up to a total of three years based on the progress achieved during the project. After a highly successful first year, the RCA was renewed for its second year in September 2015.
We were awarded another RCA by the FDA in September 2015, this time to expand the capabilities of GastroPlus to simulate the dosing of long-acting injectable microspheres. This type of dosage form is usually injected via subcutaneous or intramuscular routes, but can also be used for ocular dosing. Once again, this RCA provides up to $200,000 per year for up to three years. Under this agreement, we will develop simulation models to deal with the slow dissolution/decomposition of the microsphere carrier material that gradually releases the actual drug over periods as long as weeks or months.
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) correlates laboratory ( in vitro ) dissolution experiment results with the behavior of dosage forms in humans and animals ( in vivo ) better than traditional empirical methods.
In April 2015, we released Version 9.0 of GastroPlus. This was the largest single upgrade we've made to the program to date, and the added level of science and technology enabled valuable new functionalities that we believe provide the most advanced decision-making tool for preclinical and early clinical trial simulation and modeling analysis available today. Several of the significant enhancements include:
|·||ability to simulate the absorption and distribution of biologics (antibodies and proteins)|
|·||ability to simulate dosing to the skin, including patches, creams, ointments, and subcutaneous injections|
|·||tighter integration with our ADMET Predictor™ software to increase the utility of the program in early drug discovery.|
Our goal with GastroPlus is to integrate the best science into user-friendly software to enable pharmaceutical researchers and regulators to perform sophisticated analyses of complex drug 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 earlier into the research & development process within the pharmaceutical industry, while also helping us further penetrate the biopharmaceuticals, food, cosmetics, and general toxicology markets.
DDDPlus simulates in vitro laboratory experiments that measure the rate of dissolution of a drug and, if desired, the additives (excipients) in a particular dosage form (e.g., powder, tablet, or capsule) 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 dissolution rate for 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 conditions. A major upgrade to DDDPlus is in final stages of development and is currently expected to be released in the second quarter of fiscal year 2016.
Similar to DDDPlus, MembranePlus 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 a simulation derives from the fact that when the permeabilities of the same molecules are measured in different laboratories using (supposedly) the same experiments, 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. A few initial sales of MembranePlus have been made. Like DDDPlus was ten years ago, this program is a very new concept that requires educating scientists on how and why to use it, and our marketing and sales program has been tasked with providing that training.
On October 15, 2015 we announced the upcoming 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 and noncompartmental analysis (NCA) pharmacokinetic (PK) models for oral and intravenous doses, but was not a tool that was designed to meet all of the requirements for generating these analyses and producing report-quality output for regulatory submissions. The new standalone PKPlus program is being developed to provide the full level of functionality needed by pharmaceutical industry scientists to generate the analyses and the outputs needed to satisfy regulatory agency requirements for both NCA and compartmental PK. The program has been in development for about 17 months, and is nearing completion. We believe the potential number of users for PKPlus is large and that it has the potential to become one of our leading revenue producers.
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 forms) 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, or 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 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 been top-ranked for predictive accuracy in multiple peer-reviewed, independent comparison studies, while generating its results at a 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 usually the majority of a 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 latest release of ADMET Predictor (version 7.2, released in May) contains updated cytochrome P450 enzyme kinetics models that are seamlessly integrated into the recently released GastroPlus Version 9.0, enhancing the synergy between predicted properties and PBPK simulations and enabling discovery chemists – a new group of potential users – to use PBPK simulations. It also contains two new models related to human liver microsomal (HLM) stability, an experiment that is routinely run on newly synthesized compounds in the pharmaceutical industry. The updated models illustrate our commitment to providing the best predictive models in the industry.
We are now working on ADMET Predictor 8.0, which features a completely redesigned and modernized interface as well as a number of new capabilities to enhance the performance and user-friendliness of the program. We expect to release version 8.0 in early calendar 2016.
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 machine-learning methods 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 models with minimal training.
We are currently investigating three applications of this machine-learning engine outside of our normal pharmaceutical markets: (1) building predictive models for 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, and (3) 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 in these three areas.
We believe our machine-learning software engine has a wide variety of potential applications and we intend to pursue funding to develop customized tools based on the engine for a number of them.
MedChem Designer was launched in 2011. It was initially a molecule-drawing program, or "sketcher", but now has capabilities exceeding those of other molecule-drawing programs because of its integration with both MedChem Studio and ADMET Predictor. We provide MedChem Designer for free to our customers 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 ~150 predictions that are available. Over 15,000 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 ~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 5-6), 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 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 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 of large chemical libraries to find molecules that contain identified substructures, and it enables rapid generation of clusters (classes) of molecules that share common substructures from high-throughput screening (HTS) data. MedChem Studio version 4.0 was released during fiscal year 2014.
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 (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 both active against the target as well as 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 combined COX-1 and COX-2 inhibitors. Every molecule we designed and had synthesized hit their targets. We are not aware of any other software company that has demonstrated the ability of their software in this way.
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 provides our user community with access to new features that accelerate completion of modeling projects by decreasing run times and facilitating the comparison and exporting of results across models. These features include 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.
Contract Research and Consulting Services
Our scientists and engineers have world-class expertise in drug absorption via various dosing routes (oral, intravenous, ocular, nasal/pulmonary, and dermal), pharmacokinetics, and pharmacodynamics. They have been speakers or presenters at over 150 scientific meetings worldwide in the past four years. We frequently conduct contracted studies for large customers (including the five largest 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 currently are working with the FDA on three different Research Collaboration Agreements (RCAs): the two funded efforts for the ocular model and long-acting injectable microspheres and the unfunded IVIVC effort, all described above under "GastroPlus".
We have a reputation for high-quality analyses and regulatory reporting of data collected during preclinical experiments and clinical trials of new and existing pharmaceutical products, typically working on 30-40 drug projects per year. The modeling analysis of clinical trial data that we perform is different from the modeling analysis offered by GastroPlus; the former relies more on statistical and semi-mechanistic models, whereas the latter relies 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 the detailed understanding of the human body and the chemistry of the drug and involve 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.
At recent (2014) meetings held by the FDA and other regulatory agencies, such agencies emphasized an interest in bringing physiologically based pharmacokinetics (PBPK) into clinical pharmacology. We believe the combined strengths of the new Simulation Plus formed through the acquisition of Cognigen in September 2014 have now uniquely positioned us at the forefront of model-based drug development.
Because of the synergies achieved through the integration of Cognigen into Simulations Plus, our first full fiscal year of combined operations resulted in significantly increased revenues and earnings. Our clinical pharmacometricians in Buffalo supported by our consulting team in California are learning to use the PBPK modeling capabilities of GastroPlus and are performing such studies under new and expanded contracts with pharmaceutical customers.
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, 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. (aka 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 non-assertion 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 as follows: (a) $3,500,000 by May 20, 2014, which amount was comprised of $2,500,000 in cash and $1,000,000 worth of our common stock (which was 164,745 shares based upon the April 25, 2014 closing price per share of $6.07 per share), (b) $750,000 payable on or before April 25, 2015, (c) $750,000 payable on or before April 25, 2016, and (d) $1,000,000 payable on or before April 25, 2017. Our payment obligation described above is non-interest-bearing and will be amortized at a constant rate of $150,000 per quarter until it is completely amortized, after which no further expense will be incurred. For most quarters, we expect that this will result in a savings over 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, 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 research that was reported on was performed using our software. Many of these presentations were from industry and FDA scientists; some were from our staff.
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 training, both via the Internet 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 technical questions about methods and features in depth; (2) our scientists and engineers benefit from direct customer contact by gaining an appreciation for the environment and problems of the customer; 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 one independent distributor in Japan and two independent representatives in China who sell and market our products.
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 group following the example set in Japan. Over 750 members have joined this group to date. We support this group through coordination of online meetings each month and managing the 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.
Our pharmaceutical software products are designed and developed by our development teams in California and New York, with locations in Lancaster, Petaluma, San Jose, San Diego, and Buffalo. In addition, we have one team member working out of North Carolina and our Chief Executive Officer works primarily from Auburn, Alabama.
The principal materials and components used in the manufacture of simulation software products include CD-ROMs and instruction manuals, which are also produced in-house and through outside contractors. In-house graphic art and engineering talent enables us to accomplish this production in a cost-efficient manner.
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 management believes there is currently no significant competitive threat to GastroPlus, DDDPlus, or MembranePlus; however, in spite of a high barrier to entry, one could be developed over time. 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.
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 that the success of our two NCE projects in which we successfully designed, synthesized, and tested new lead molecules to treat malaria as well as COX-2/COX-1 will further promote the abilities of our ADMET Design Suite for rapid and cost-effective design of lead compounds.
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) attract and retain a highly skilled scientific and engineering team, and (5) develop and maintain relationships with research and development departments of pharmaceutical companies, universities and government agencies.
We actively seek acquisitions to expand the pharmaceutical software and services business. We plan to continue our efforts to find strategic targets and alliances that will enhance our position in the industry.
Our business strategy is to do the things we need to do to promote growth both organically (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 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. 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, 2015 we distributed $0.20 per share in dividends to our shareholders. And in November 2015 we distributed another quarterly dividend of $0.05 per share. We anticipate future dividends to be $0.05 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 November 30, 2015 and 2014.
The following table sets forth our consolidated condensed statements of operations (in thousands) and the percentages that such items bear to net sales:
|Three Months Ended|
|Cost of revenues||1,083||22.4||998||24.4|
|Selling, general and administrative||1,676||34.6||2,079||50.9|
|Research and development||351||7.3||260||6.4|
|Total operating expenses||2,027||41.9||2,339||57.2|
|Income from operations||1,728||35.7||749||18.3|
|Income from operations before income taxes||1,717||35.5||746||18.2|
|(Provision for) income taxes||(611||)||(12.6||)||(217||)||(5.3||)|
Consolidated net Revenues increased $752,000 or 18.4% to $4.838M in the first fiscal quarter of Fiscal Year 2016 ("1QFY16") from $4.086M in the first fiscal quarter of Fiscal Year 2015 ("1QFY15"). $293,000 of this increase was from new revenues generated by our Buffalo Division, representing a 25.9% increase over 1QFY15. Net revenues of the Lancaster Division increased $459,000 or 15.6%, to $3.41 million in 1FQY16 from $2.95 million in 1QFY15. Software sales increased $324,000 or 11.8%, while analytical study revenues increase by $121,000 or 89% over 1QFY15.
Cost of Revenues
Consolidated Cost of Revenues increased by $85,000 in 1QFY16 to $1.083 million from $998,000 in 1QFY15. The increase came mainly from a $33,000 increase in software amortization costs and a $49,000 increase in training costs for workshops in 1QFY16.
Cost of Revenues as a percentage of revenue decreased from 24.4% in 1QFY15 to 22.4% in 1QFY16. A significant portion of Cost of Revenues for pharmaceutical software products is the systematic amortization of capitalized software development costs, which is an independent fixed cost rather than a variable cost related to sales. This amortization cost increased approximately $33,000 in 1QFY16 compared with 1QFY15.
Consolidated gross margin increased $667,000 or 21.6%, to $3,755 million in 1QFY16 from $3.088 million in 1QFY15, a result of containing costs while increasing revenues.
Selling, General and Administrative Expenses
Selling, general, and administrative (SG&A) expenses decreased $403,000, or 19.4% to $1.68 million in 1QFY16 from $2.08 million in 1QFY15.
|o||No significant increases in SG&A expenses in 1QFY16 compared to 1QFY15.|
|o||Consulting Fees - In 1QFY15, we paid approximately $400,000 in one-time fees and expenses to our financial advisor/business broker related to the Cognigen acquisition. There were no such expenses in the current reporting period.|
|o||Trade show costs decreased $44,000 in 1QFY16.|
Research and Development
Total research and development cost increased $84,000 in 1QFY16 compared to 1QFY15. We incurred approximately $618,000 of research and development costs during 1QFY16. Of this amount, $267,000 was capitalized and $351,000 was expensed. In 1QFY15, we incurred $534,000 of research and development costs, of which $274,000 was capitalized and $260,000 was expensed.
Other income (expense)
Net other income (expense) in 1QFY15 decreased by $8,000 to a net expense of $11,000 from net expense of $3,000 in 1QFY15. This is due mainly to currency exchange losses in 1QFY16 due to currency fluctuations.
Provision for Income Taxes
The provision for income taxes was $611,000 for 1QFY16 and $217,000 for 1QFY15. Our effective tax rate increased to 35.6% in 1QFY16 from 29.1% in 1QFY15, due to higher income and attendant lower percentage of permanent tax deductions in 1QFY16 for R&D and other credits.
Net income increased by $577,000, or 109.2%, to $1.106 million in 1QFY16 from $529,000 in 1QFY15. The increase comes from two main sources: increased revenues of $752,000; and reduced SG&A expense in 2016, since in 2015 we incurred approximately $400,000 of one-time consulting costs associated with the Cognigen acquisition.
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 eight 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.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our risk from exposure to financial markets is limited to foreign exchange variances and fluctuations in interest rates. We may be subject to some foreign exchange risks. Most of our business transactions are in U.S. dollars, although we generate significant revenues from customers overseas. The exception is that we have been compensated in Japanese yen by Japanese customers and PRC Yuan (RMB) by Chinese customers. In the future, if foreign currency transactions increase significantly, we may mitigate this effect through foreign currency forward contracts whose mark-to-market gains or losses are recorded in "Other Income or expense" at the time of the transaction. To date, exchange rate exposure has not resulted in a material impact.
Item 4. Controls and Procedures
We are responsible for maintaining disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on management's evaluation (with the participation of our chief executive officer and chief financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective.
Management's Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting, as defined in Exchange Act Rule 13a-15(f). Our internal controls over financial reporting are designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed financial statements for external purposes in accordance with generally accepted accounting principles.
No changes were made in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during our most recent fiscal quarter that have materially affected or are reasonably likely to materially affect, our internal controls over financial reporting.
Our management, including our CEO and CFO, does not expect that our disclosure controls or internal controls over financial reporting will prevent all errors or all instances of fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and any design may not succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitation of a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Part II. Other Information
Item 1. Legal Proceedings
Except as described below, we are not a party to any legal proceedings and are not aware of pending legal proceedings of any kind.
In June 2014, the Company was served with a complaint in a civil action entitled Sherri Winslow v. Incredible Adventures, Inc., et al. (Los Angeles Superior Court Case No. BC545789) alleging wrongful death and seeking unspecified damages arising out of a May 18, 2012 plane crash in the State of Nevada. The Company's Chief Executive Officer owns the subject aircraft and is also a named defendant. The complaint alleged that the Company was the owner of the subject aircraft. The Company denied all material allegations against it, including that it owns or has ever owned any interest in the subject aircraft. On November 25, 2014, the plaintiff and the Company signed a stipulation of dismissal pursuant to which the plaintiff agreed to dismiss the Company without prejudice. The Company planned to prepare a dismissal with prejudice to be signed on behalf of the plaintiff in the event the plaintiff did not discover evidence during a nine month period to and including August 31, 2015 that justified bringing the Company back into the litigation. The Company did not receive notification of any such discovery and is in the process of preparing documents for the plaintiff's final dismissal with prejudice.
|Item 1A.||Risk factors|
|Item 2.||Changes in Securities|
|Defaults Upon Senior Securities|
|Item 4.||Mine Safety Disclosures|
|Item 5.||Other Information|
|2.1||Agreement and Plan of Merger, dated July 23, 2014, by and among the Company, Cognigen Corporation and the other parties thereto. (13)^|
|3.1||Articles of Incorporation of the Company. (5)|
|3.2||Amended and Restated Bylaws of the Company. (5)|
|4.1||Articles of Incorporation of the Company. (incorporated by reference to Exhibit 3.1 hereof)|
|4.2||Amended and Restated Bylaws of the Company. (incorporated by reference to Exhibit 3.2 hereof)|
|4.3||Form of Common Stock Certificate (1)|
|4.4||Share Exchange Agreement (1)|
|10.1||The Company's 1996 Stock Option Plan and forms of agreements relating thereto (1) (†)|
|10.2(a)||Exclusive License Software Agreement by and between the Company and Therapeutic Systems Research Laboratories dated June 30, 1997. (2)|
|10.2(b)||Termination and Non-Assertion Agreement entered into on May 15, 2014 by and between the Company and TSRL, Inc. (11)|
|10.3(a)||The Company's 2007 Stock Option Plan. (3) (†)|
|10.3(b)||The Company's 2007 Stock Option Plan as amended as of December 6, 2013. (10) (†)|
|10.4(a)||Lease, dated May 12, 2005 by and between Freeway Ventures, LLC and the Company. (6)|
|10.4(b)||Notice of Election to Extend Term of Lease by and between the Company and Crest Development LLC (formerly Freeway Ventures LLC) dated July 29, 2010.(4)|
|10.4(c)||One Amendment to Lease by and between the Company and Crest Development LLC entered into as May 23, 2013. (8)|
|10.5||Stock Purchase Agreement by and among the Company, Words+, Inc., and Prentke Romich Company dated November 15, 2011. (7)|
|10.6||Employment Agreement by and between the Company and Walter S. Woltosz, dated as of August 22, 2013. (9) (†)|
|10.7||Employment Agreement by and between the Company and Walter S. Woltosz, dated as of August 28, 2014. (12) (†)|
|10.8||Employment Agreement by and between the Company and Thaddeus H Grasela Jr. dated as of September 2, 2014. (12) (†)|
|10.9||Employment Agreement by and between the Company and Walter S. Woltosz, dated as of July 9, 2015. (14) (†)|
|21.1||List of Subsidiaries*|
|23.1||Consent of Independent Registered Public Accounting Firm*|
|31.1||Section 302 – Certification of the Principal Executive Officer*|
|31.2||Section 302 – Certification of the Principal Financial Officer*|
|32.1||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.|
|(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 the Company's Form 10-KSB for the fiscal year ended August 31, 1997.|
|(3)||Incorporated by reference to the Company's Form 10-K for the fiscal year ended August 31, 2009.|
|(4)||Incorporated by reference to the Company's Form 10-K for the fiscal year ended August 31, 2010.|
|(5)||Incorporated by reference to the Company's Form 10-K for the fiscal year ended August 31, 2011.|
|(6)||Incorporated by reference to the Company's Form 10-KSB for the fiscal year ended August 31, 2006.|
|(7)||Incorporated by reference to the Company's Form 8-K filed November 16, 2011.|
|(8)||Incorporated by reference to the Company's Form 10-Q filed July 10, 2013.|
|(9)||Incorporated by reference to the Company's Form 10-K filed November 18, 2013.|
|(10)||Incorporated by reference to the Company's Form 10-Q filed April 9, 2014.|
|(11)||Incorporated by reference to the Company's Form 8-K filed May 19, 2014.|
|(12)||Incorporated by reference to the Company's Form 8-K filed September 4, 2014.|
|(13)||Incorporated by reference to the Company's Form 8-K/A filed November 18, 2014.|
|(14)||Incorporated by reference to the Company's Form 8-K filed July 15, 2015.|
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 January 14, 2016.
|Simulations Plus, Inc.|
|Date: January 14, 2016||By:||/s/ John R. Kneisel|
|John R. Kneisel|
|Chief Financial Officer|