UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
December 3, 2014
(Date of the earliest event reported)
Simulations Plus, Inc.
(Exact name of registrant as specified in its charter)
California | 001-32046 | 95-4595609 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
42505 10th Street West, Lancaster, California 93534-7059
(Address of principal executive offices) (Zip Code)
661-723-7723
Registrant's telephone number, including area code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure
On December 3, 2014, Simulations Plus, Inc., a California corporation, attended the LD Micro investor conference in Los Angeles, CA. Simulations Plus presented and held one-on-one meetings with investors. The PowerPoint slides, which were used for discussion at the Conference, are attached herein as exhibit 99.2 to this Current Report on Form 8-K.
Item 8.01 Other Events
On December 3, 2014, Simulations Plus, Inc., a California corporation (the "Company"), issued a press release announcing preliminary revenues for its first quarter of fiscal year 2015 ended November 30, 2014. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth in this Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in this report on Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.
This report on Form 8-K (the "Report"), including the disclosures set forth herein, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms "anticipates," "expects," "estimates," "believes" and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Report or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the "Commission"), reports to the stockholders of Simulations Plus, Inc., a California corporation (the "Company" or "us," "our" or "we") and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management's best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 | Press release issued on December 3, 2014. |
99.2 | PowerPoint presentation used at the LD Micro Investor Conference held on December 3, 2014. |
2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SIMULATIONS PLUS, INC. | |
Dated: December 4, 2014 | By: /s/ John R Kneisel |
John R. Kneisel | |
Chief Financial Officer |
3 |
Exhibit 99.1
Simulations Plus
Integrating Science and Software
For Further Information:
Simulations Plus, Inc.
42505 10th Street West
Lancaster, CA 93534-7059
CONTACT: | |
Simulations Plus Investor Relations | Hayden IR |
Ms. Renee Bouche | Mr. Cameron Donahue |
661-723-7723 | 651-653-1854 |
renee@simulations-plus.com | cameron@haydenir.com |
For Immediate Release: | |
December 3, 2014 |
Simulations Plus Reports First Quarter FY2015 Preliminary Revenues
Preliminary revenues increase 50% to first quarter record $3.96 million
LANCASTER, CA, December 3, 2014 – Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported preliminary revenues for its first quarter of fiscal year 2015 ended November 30, 2014 (1QFY15).
Mr. John Kneisel, chief financial officer of Simulations Plus, said, “We are pleased to report that with our acquisition of Cognigen Corporation at the beginning of 1QFY15, our revenues for this first quarter set a new record of $3.96 million, an increase of 50% from $2.64 million in 1QFY14. Revenues from the Simulations Plus division increased 11.5%, to $2.94 million from $2.64 million, while Cognigen Corporation added another $1.02 million.”
Walt Woltosz, chairman and chief executive officer of Simulations Plus and Cognigen, added: “The acquisition of Cognigen Corporation has started off our fiscal year with a significant jump in revenues over the first quarter of last fiscal year. Providing timely financial information has long been a policy of Simulations Plus. The nature of our Cognigen division’s business, which is focused on consulting studies, requires estimation of percentage completion on many contracts in order to provide these preliminary revenues. Final revenues will be provided when we file our quarterly report on Form 10-Q in January. ”
Mr. John DiBella, vice president for marketing and sales of Simulations Plus, said, “In addition to the revenues added by Cognigen, sales of Simulations Plus software and services have continued a consistent growth pattern with the 11.5% increase. During 1QFY15, we again achieved renewal rates well in excess of 90% and added 23 new customers. In addition, our newest software product, MembranePlus™, was featured in a webinar yesterday with nearly 100 attendees.”
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation and modeling software, which is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, agrochemical, and food industry companies worldwide. Simulations Plus, Inc., is headquartered in Southern California and trades on the NASDAQ Capital Market under the symbol “SLP.” For more information, visit our Web site at www.simulations-plus.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.
Exhibit 99.2
Simulations Plus, Inc . and Cognigen Corp (NASDAQ:SLP) LD Micro Investor Conference Los Angeles December 3, 2014 Copyright (c) 2014 Simulations Plus, Inc. 1
With the exception of historical information, the matters discussed in this presentation are forward - looking statements that involve a number of risks and uncertainties. The actual results of the Company could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: continuing demand for the Company’s products, competitive factors, the Company’s ability to finance future growth, the Company’s ability to produce and market new products in a timely fashion, the Company’s ability to continue to attract and retain skilled personnel, and the Company’s ability to sustain or improve current levels of productivity. Further information on the Company’s risk factors is contained in the Company’s quarterly and annual reports and filed with the Securities and Exchange Commission. Safe Harbor Statement Copyright (c) 2014 Simulations Plus, Inc. 2
Major software provider for pharmaceutical research and development Consulting services for problem drugs and formulations Expertise and software tools span from earliest drug discovery through clinical trials and beyond patent life to supporting generic companies Three different active collaborations with U.S. FDA – one funded by FDA at $200,000/year for up to three years was just awarded Currently distributing dividend of $0.20/year per share ($ 0.05/ quarter) New applications being explored in aerospace and general healthcare Acquisition of Cognigen Corp in September more than doubles workforce, expected to add $4 - 5 million to revenues in FY15 – first combined fiscal quarter just completed on November 30 – preliminary consolidated revenues up 50% over last year’s first fiscal quarter Simulations Plus, Inc. Overview Copyright (c) 2014 Simulations Plus, Inc. 3
N H O OH O CH 3 CH 3 CH 3 Discovery Preclinical Clinical MedChem Studio™ MedChem Designer™ GastroPlus™ DDDPlus ™ ADMET Predictor™ Simulations Plus Products & Services Consulting Services & Collaborations – Now Including Cognigen for Clinical Pharmacology MembranePlus™ 4
Modeling & simulation support for 30 - 40 drugs per year Total of >100 different compounds over the last 5 years Well - established quality management system and successful client audit record 44 client audits over the last 10 years; no findings Track record of successful regulatory submissions utilizing pharmacometric modeling and simulation >25 regulatory submissions over the last 5 years alone New KIWI proprietary software provides access to Cognigen cloud – licensed to two organizations to date Little marketing and sales efforts prior to acquisition – now can cost - effectively piggy - back on Simulations Plus’ activities Cognigen Division: Overview Copyright (c) 2014 Simulations Plus, Inc. 5
6 • Data assembly and exploratory analyses • PK/PD modeling of drug concentrations and patient outcomes from Phase 1, 2 and 3 studies • Clinical trial simulations to guide study design • Briefing books for regulatory interactions • Regulatory submissions • Scientific writing • Training workshops Cognigen Selected Services
7 • Worked with 22 clients on 62 projects covering 38 different compounds • Average length of current client relationship is 6 years ranging from 1 to 14 years • 6 new clients • 6 Regulatory Submissions Cognigen Calendar 2014 Overview
Cognigen Therapeutic Areas Copyright (c) 2014 Simulations Plus, Inc. 8
9 • Significant investment in IT infrastructure and workflow processes • Recently upgraded computer systems, implemented automated offsite backup storage, and installed green technology to reduce computer cooling costs • KIWI - a validated platform for model development and private cloud computing Cognigen Infrastructure
Additional Growth Opportunities • MembranePlus™ : new software product to simulate in vitro permeability experiments • Released in 1Q15 • Webinar held December 2, 2014 – nearly 100 attendees • Continued enhancement of current software products expands application space: • Dermal and improved oral cavity dosing modules in GastroPlus™ • Addition of biologics (antibodies) to GastroPlus • Addition of large animals to GastroPlus • Penetration of clinical pharmacology departments to provide more detailed mechanistic modeling for clinical trial data analysis – regulatory agencies want this • Cloud offerings • AEROModeler ™ - application of our artificial neural network ensemble (ANNE) technology to predict aerodynamic force coefficients for missiles at arbitrary Mach number and angle of attack - much faster than conventional methods • Presented at our first aerospace conference in June 2014 • MRIModeler™ - application of our artificial neural network ensemble (ANNE) technology to analysis of magnetic resonance imaging (MRI) data to classify patients as healthy or likely to experience various disease states • Presented at our first MRI conference in September 2014 Copyright (c) 2014 Simulations Plus, Inc. 10
Marketing and Sales Program • Conferences/Scientific Meetings continue to be primary source of leads • During FY14 we participated in 48 scientific meetings and conferences in the U.S., Europe, and Asia with 30 scientific posters and presentations. In 4Q14 , we presented at our first aerospace conference. (In 1Q15 we presented at our first MRI conference.) • Trainings and Workshops • Conducted 21 on - site training courses at client sites in FY14 • Conducted training workshops in Germany, New Jersey, Japan and Korea • 2015 workshops scheduled for U.S., Europe, Asia • Strategic Digital Marketing Initiatives • Hosted 7 webinars on our new software updates & applications - over 1100 registrations • Active updates of LinkedIn, Facebook, and Twitter accounts help with outreach programs • We believe fundamental industry shift continues – GastroPlus User Group now has over 560 members on LinkedIn – Added 75 new customers during FY14 (includes new companies as well as new departments within existing large customers ) – added 23 new customers in 1QFY15 – New companies in U.S., Europe, India, Japan, China, and Korea – New divisions at the U.S. EPA and Chinese FDA Copyright (c) 2014 Simulations Plus, Inc. 11
FY14 Sales – by Region Europe 26% North America 49% Asia 25% South America <1% Japan = 61% India = 15% China = 12% Korea = 6%
10 11 9 9 14 17 12 14 15 21 13 10 18 18 16 9 15 22 20 18 Q1 Q2 Q3 Q4 2010 2011 2012 2013 2014 2015 New Customers by Quarter Copyright (c) 2014 Simulations Plus, Inc. 13 23
• FY14 compared to FY13: – Sales increased by $1.4 million or 13.8% to $11.5 million from $10.1 million – Cost of sales as a percentage of sales decreased 1.3% or $17,000 14.2% from 16.3% in FY13 • Decrease was attributable to a reduction in royalty expenses attributable to buying out a former royalty agreement – Gross profit increased 16.7% to $9.8 million from $8.4 million in FY13 – Gross margin increased to 85.8% from 83.7% – SG&A increased 25.1% to $4.4 million from $ 3.5 million • As a percent of revenues, SG&A increase to 38.7% from 35.2% • Due to increases in marketing, travel, one - time consulting and professional fees, sales commissions, and salaries and wages. • One - time professional fees associated with the Cognigen acquisition accounted for almost 75% of the 3.4% increase SLP FY14 Highlights Fiscal year ended 8/31/ 14 (last reported period): Copyright (c) 2014 Simulations Plus, Inc. 14
• FY14 compared to FY13 ( con’t ) – R&D expense increased 18.7% to $953,000 from $802,000 the prior year • Increase was due to an increase in life science staffing and included R&D expenditures for COX2/COX1 NCE project of approximately $50,000 – Net Income increased by $139,000 or 4.8% to $3.0 million in FY14 from $2.7 million in FY13 – Diluted earnings per share was $0.1844, an increase of $0.0075 from $0.1769 in FY13 – Cash dividends totaling $0.19/share were distributed during FY14 SLP FY14 Highlights Fiscal year ended 8/31/14: Copyright (c) 2014 Simulations Plus, Inc. 15
Income Statement FY14 vs FY13 ($ millions) FY14 FY13 Net sales 11.461 10.071 Gross profit 9.831 8.424 Gross profit margin 85.8% 83.7% SG&A 4.440 3.550 R&D 0.952 0.802 Total operating expenses 5.392 4.352 Income from operations 4.439 4.257 Other income .074 0.184 Income from operations before income taxes 4.513 4.256 Net income 3.025 2.8866 Diluted earnings per share 0.1844 0.1769 Copyright (c) 2014 Simulations Plus, Inc. 16
FY14 Recap Sales increase & Net income Sales Incr 1,390,000 Royalties 425,000 Software Amort - 90,000 TSRL Amort - 175,000 Net incr. from Sales/COGS 1,550,000 Increased expenses - 1,350,000 Increase in net income 225,000 Additional Expenses Labor related expense increase 304,000 Legal costs 288,000 Excel Partners 96,000 Sales rep Commissions 144,000 Other Expensed R&D 100,000 Travel 80,000 CEO bonus 60,000 NCE 50,000 Decrease in other Income - (Sublease and Forex) 110,000 Income tax expense 118,000 Increase in expenses 1,350,000 1 7
Selected Balance Sheet Items ($ millions) August 31, 2014 August 31, 2013 Cash and cash equivalents $8.614 $10.179 Cash per share 0.52 0.62 Total current assets 11.533 12.972 Total assets 20.981 16.063 Total current liabilities 1.391 0.626 Total liabilities 5.545 1.821 Current ratio 8.29 20.7 Shareholders’ equity 15.435 14.242 Total liabilities and shareholders’ equity 20.981 16.063 Shareholders’ equity per diluted share 0.94 0.87 *Cash as of today is $5.9 million after Cognigen acquisition Copyright (c) 2014 Simulations Plus, Inc. 18
$1.4 $1.8 $2.0 $1.1 $1.7 $2.2 $2.3 $1.3 $2.1 $2.6 $2.6 $1.4 $2.2 $2.8 $2.8 $1.6 $2.3 $3.1 $3.1 $1.6 $2.6 $3.1 $2.0 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 Revenues by Quarter (pro forma prior to 2012) $3.7 Copyright (c) 2014 Simulations Plus, Inc. 19 $ 3.96 preliminary
$1.24 $1.53 $1.75 $0.71 $1.45 $1.93 $1.97 $1.07 $1.70 $2.21 $2.21 $1.12 $1.90 $2.39 $2.33 $1.32 $1.90 $2.62 $2.64 $1.26 $2.19 $2.59 $1.54 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 Gross Profit by Fiscal Quarter (pro forma prior to 2012) $3.5 Copyright (c) 2014 Simulations Plus, Inc. 20
$0.55 $0.73 $0.93 $0.20 $0.73 $1.28 $1.23 $0.36 $1.00 $1.48 $1.48 $0.27 $1.23 $1.38 $1.48 $0.58 $1.09 $1.76 $1.73 $0.44 $1.20 $1.35 $0.67 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 EBITDA by Fiscal Quarter $2.1 Copyright (c) 2014 Simulations Plus, Inc. 21
Net Income by Quarter (pro forma prior to 2012) $0.33 $0.47 $0.53 $0.17 $0.44 $0.85 $0.74 $0.21 $0.56 $0.91 $1.05 $0.17 $0.76 $0.84 $0.87 $0.35 $0.59 $1.06 $0.99 $0.24 $0.69 $0.81 $1.31 $0.22 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 Copyright (c) 2014 Simulations Plus, Inc. 22
$1.59 $0.80 $0.80 $2.24 $0.00 $0.48 $0.48 $0.64 $0.81 $0.81 $0.82 $0.82 $1.97 $2.50 $12.66 $13.24 $12.89 $12.70 $11.38 $9.33 $9.76 $10.00 $10.18 $10.56 $10.9* $7.76 $8.8* $5.90 Q 4 F Y 1 1 Q 1 F Y 1 2 Q 2 F Y 1 2 Q 3 F Y 1 2 Q 4 F Y 1 2 Q 1 F Y 1 3 Q 2 F Y 1 3 Q 3 F Y 1 3 Q 4 F Y 1 3 Q 1 F Y 1 4 Q 2 F Y 1 4 Q 3 F Y 1 4 Q 4 F Y 1 4 Q 1 F Y 1 5 $ M i l l i o n s TSRL Proceeds from Sale of Subsidiary Dividend Paid Cash Returning Cash to Shareholders * as of 11/24/ 2014 after using $2.1 for the Cognigen acquisition Copyright (c) 2014 Simulations Plus, Inc. 23
Summary • For FY14: - Revenues and earnings continued six - year - plus profitable trend - Buyout of royalty agreement reduces expenses going forward - Cognigen acquisition increases revenues, expands offerings into clinical pharmacology • Continuing to Grow: - >10% staff expansion in FY14 in Simulations Plus, plus 35 new staff added with acquisition of Cognigen - 50% revenue growth ( preliminary) seen in first combined fiscal quarter • Aggressive Marketing and Sales Activities - Continue intensive conference/trade show/workshop schedule - Workshops scheduled for North America, Europe, and Asia in 2015 - Expand Cognigen marketing and sales activities • Strong cash position – returning cash to shareholders - Cash dividends totaling approximately $9 million have been distributed, yet cash remains at $5.9 million as of today . Copyright (c) 2014 Simulations Plus, Inc. 24
Q&A Copyright (c) 2014 Simulations Plus, Inc. 25
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