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
January 9, 2018
(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:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On January 9, 2018, Simulations Plus, Inc., a California corporation (the "Company"), issued a press release announcing financial results for its first quarter of fiscal year 2018 ended November 30, 2017. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On January 9, 2018, Simulations Plus, Inc., a California corporation (the "Company"), held an investor conference call reporting its first quarter financial results of fiscal year 2018 ended November 30, 2017. The PowerPoint slides, which were used for this Investor Conference Call, are attached herein as exhibit 99.2 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 January 9, 2018. |
99.2 | PowerPoint presentation at the Investor Conference Call on January 9, 2018. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SIMULATIONS PLUS, INC. | |
Dated: January 10, 2018 | By: /s/ John R. Kneisel |
John R. Kneisel | |
Chief Financial Officer |
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Exhibit 99.1
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:
January 9, 2018
Simulations Plus Reports First Quarter FY2018 Financial Results
Consolidated net income up 26.0%; diluted earnings per share increased 22.8%
LANCASTER, CA, January 9, 2018 – Simulations Plus, Inc. (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for all stages of pharmaceutical discovery and development from the earliest discovery through all phases of clinical trials, today reported financial results for its first quarter of fiscal year 2018, the period ended November 30, 2017 (1QFY18).
1QFY18 highlights compared with 1QFY17:
· | Net revenues increased 30.5%, or $1.7 million, to a new first quarter record $7.1 million vs. $5.4 million |
· | Gross profit increased 30.6%, or $1.3 million, to $5.3 million from $4.1 million |
· | SG&A was $2.4 million, an increase of 29.2%, or $545,000, from $1.9 million |
· | SG&A as a percentage of revenues decreased slightly to 34.1% from 34.4% |
· | Income before taxes increased $550,000, or 27.9%, to $2.5 million from $2.0 million |
· | Net income increased $354,000, or 26.0%, to $1.7 million from $1.4 million |
· | Diluted earnings per share increased 22.8%, or $0.02, to $0.10 from $0.08 per share |
John Kneisel, chief financial officer of Simulations Plus, said, “Revenue growth in our core divisions in Lancaster and Buffalo coupled with the new revenues and profits from DILIsym Services acquired in the last quarter of our prior fiscal year produced a 26% growth in net income and a two-cent growth in EPS, resulting in a strong start to the new fiscal year.”
Walt Woltosz, chairman and chief executive officer of Simulations Plus, added, “We’re very pleased to report these first quarter results for fiscal year 2018, which begins the first full fiscal year after our acquisition of DILIsym Services, Inc., in June of last year. This is yet another record quarter, setting an all-time record for revenues for any quarter at over $7 million, and record high earnings for a first fiscal quarter. We continue to push forward the cutting edge of simulation and modeling for pharmaceutical research, and it is clear that the industry continues to adopt simulation and modeling tools at a steady pace in its effort to increase productivity and decrease overall costs of bringing new medicines to market for all of us.”
Investor Conference Call
The Company has announced an investor conference call that will be webcast live at 1:15 p.m. PST/4:15 p.m. EST on Tuesday, January 9, 2018. All interested parties are invited to join the call by registering here. On registering, you will receive a confirmation e-mail with instructions for joining the call. Please dial in five to ten minutes prior to the scheduled start time. For listen-only mode, you may dial (562) 247-8321, and enter access code 336-145-278. A replay will be available on the Simulations Plus website following the call.
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About Simulations Plus, Inc.
Simulations Plus, Inc. is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury and nonalcoholic fatty liver disease. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website 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. 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 our new software products as well as 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, 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.
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SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
As of
(Unaudited) | (Audited) | |||||||
November 30, | August 31, | |||||||
2017 | 2017 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 7,045,756 | $ | 6,215,718 | ||||
Accounts receivable, net of allowance for doubtful accounts of $0 | 5,230,824 | 4,048,725 | ||||||
Revenues in excess of billings | 1,361,242 | 1,481,082 | ||||||
Prepaid income taxes | – | 462,443 | ||||||
Prepaid expenses and other current assets | 348,708 | 459,902 | ||||||
Total current assets | 13,986,530 | 12,667,870 | ||||||
Long-term assets | ||||||||
Capitalized computer software development costs, net of accumulated amortization of $10,080,778 and $9,795,469 | 4,529,380 | 4,307,600 | ||||||
Property and equipment, net | 305,634 | 291,135 | ||||||
Intellectual property, net of accumulated amortization of $2,326,459 and $2,095,417 | 6,598,541 | 6,829,583 | ||||||
Other intangible assets net of accumulated amortization of $584,375 and $495,000 | 3,905,625 | 3,995,000 | ||||||
Goodwill | 10,387,198 | 10,387,198 | ||||||
Other assets | 37,227 | 34,082 | ||||||
Total assets | $ | 39,750,135 | $ | 38,512,468 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 141,815 | $ | 240,892 | ||||
Accrued payroll and other expenses | 1,085,065 | 983,293 | ||||||
Income taxes payable | 404,600 | – | ||||||
Current portion - Contracts payable | 3,150,000 | 247,328 | ||||||
Billings in excess of revenues | 602,233 | 216,958 | ||||||
Deferred revenue | 270,250 | 353,962 | ||||||
Total current liabilities | 5,653,963 | 2,042,433 | ||||||
Long-term liabilities | ||||||||
Deferred income taxes,net | 4,791,460 | 4,926,960 | ||||||
Payments due under Contracts payable | 2,626,376 | 5,738,188 | ||||||
Total liabilities | 13,071,799 | 12,707,581 | ||||||
Commitments and contingencies | ||||||||
Shareholders' equity | ||||||||
Preferred stock, $0.001 par value 10,000,000 shares authorized no shares issued and outstanding | $ | – | $ | – | ||||
Common stock, $0.001 par value 50,000,000 shares authorized 17,287,652 and 17,277,604 shares issued and outstanding | 7,288 | 7,278 | ||||||
Additional paid-in capital | 12,303,662 | 12,109,141 | ||||||
Retained earnings | 14,367,386 | 13,688,468 | ||||||
Total shareholders' equity | 26,678,336 | $ | 25,804,887 | |||||
Total liabilities and shareholders' equity | $ | 39,750,135 | $ | 38,512,468 |
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SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended November 30,
(Unaudited) | ||||||||
2017 | 2016 | |||||||
Net Revenues | $ | 7,068,782 | $ | 5,417,933 | ||||
Cost of revenues | 1,735,608 | 1,335,982 | ||||||
Gross margin | 5,333,174 | 4,081,951 | ||||||
Operating expenses | ||||||||
Selling, general, and administrative | 2,408,514 | 1,863,555 | ||||||
Research and development | 360,817 | 290,299 | ||||||
Total operating expenses | 2,769,331 | 2,153,854 | ||||||
Income from operations | 2,563,843 | 1,928,097 | ||||||
Other income (expense) | ||||||||
Interest income | 4,310 | 4,455 | ||||||
Interest expense | (38,470 | ) | – | |||||
Gain(loss) on currency exchange | (12,678 | ) | 34,928 | |||||
Total other income (expense) | (46,838 | ) | 39,383 | |||||
Income before provision for income taxes | 2,517,005 | 1,967,480 | ||||||
Provision for income taxes | (800,999 | ) | (605,915 | ) | ||||
Net Income | $ | 1,716,006 | $ | 1,361,565 | ||||
Earnings per share | ||||||||
Basic | $ | 0.10 | $ | 0.08 | ||||
Diluted | $ | 0.10 | $ | 0.08 | ||||
Weighted-average common shares outstanding | ||||||||
Basic | 17,282,132 | 17,226,192 | ||||||
Diluted | 17,859,683 | 17,409,134 |
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Exhibit 99.2
(NASDAQ:SLP) Investor Conference Call January 9, 2018
2 With the exception of historical information, the matters discussed in this presentation are forward - looking statements that involve a number of risks and uncertainties . The actual results of the Company could differ significantly from those statements . Factors that could cause or contribute to such differences include, but are not limited to : continuing demand for the Company’s products, competitive factors, the Company’s ability to finance future growth, the Company’s ability to produce and market new products in a timely fashion, the Company’s ability to continue to attract and retain skilled personnel, and the Company’s ability to sustain or improve current levels of productivity . Further information on the Company’s risk factors is contained in the Company’s quarterly and annual reports and filed with the Securities and Exchange Commission . Safe Harbor Statement
3 Highlights Walter S. Woltosz CEO and Chairman
4 • Global provider of software and consulting solutions for R&D • Earliest drug discovery – when a chemist first draws a molecule • Preclinical development (lab and animals) through first - in - human trials • Safety research and risk assessment • Phase 2 and 3 clinical trials • Beyond patent life to supporting generic companies • Integration of data from multinational R&D efforts • 1QFY18 • Revenues up $1.7 million (30.5%) to $7.1 million • Net income up $354,000 (26.0%) to $1.7 million • Diluted earnings per share up 22.8% to 10¢ per share • Software renewal rates: 80% (accounts); 88%(fees) • 21 new software clients added • Explosive consulting pipeline resulted in significant increase in revenues Overview
N H O OH O CH 3 CH 3 CH 3 ADMET Predictor™ GastroPlus ™ MedChem Studio™ MedChem Designer™ DDDPlus ™ MembranePlus™ Consulting Services and Collaborations Discovery Preclinical Clinical PKPlus™ KIWI™ Simulations Plus: Your End - to - end M&S Solutions Provider DILIsym ® NAFLDsym™ 5
6 FDA Voice blog: July 7 th , 2017
GastroPlus PBPK Consulting from Simulations Plus: Regulatory Interactions • Since 2015, our consulting team has built PBPK models and written reports for internal review and submissions to various regulatory agencies for the following types (and numbers) of projects: – Preclinical development and First - in - Human predictions (16) – Formulation optimization (15) – DDI predictions (10) – Virtual bioequivalence trial simulations (10) – Pediatric population simulations and dose projections (8) – Food effect modeling (7) – Pulmonary/dermal/ocular/oral cavity product development (7) – Parent - metabolite and prodrug PBPK modeling (6) – Mechanistic IVIVCs (5) 7
8 Financial Overview John Kneisel Chief Financial Officer
9 Income Statement: 1QFY18 Versus 1QFY17 (in millions) Lancaster Buffalo North Carolina (ACQ. 6/01/17) 1QFY18 1QFY17 Diff % chg Net sales $ 4.0 $ 1.9 $ 1.1 $ 7.1 $ 5.4 $ 1.7 30.5% Gross profit 3.3 1.2 0.8 5.3 4.1 1.3 30.6% Gross profit margin 82.4% 63.1% 71.2% 75.4% 75.3% 0.1% 0.1% SG&A $ 1.4 $ 0.7 $ 0.3 $ 2.4 $ 1.9 $ 0.6 29.2% R&D 0.3 0.0 0.0 0.4 0.3 0.1 24.3% Total operating expenses 1.7 0.7 0.4 2.8 2.2 0.6 28.6% Income from operations 1.6 0.5 0.4 2.6 1.9 0.6 33.0% Other income (expense) (0.1) 0.00 0.00 (0.1) 0.0 (0.1) - 218.9% Income before income taxes 1.6 0.5 0.4 2.5 2.0 0.5 27.9% Net income $ 1.1 $ 0.3 $ 0.3 $ 1.7 $ 1.4 $ 0.4 26.0% Diluted earnings per share (in dollars) $ 0.10 $ 0.08 $ 0.02 22.8% EBITDA $ 2.0 $ 0.6 $ 0.6 $ 3.2 $ 2.5 $ 0.7 27.1%
10 Consolidated Revenues: Fiscal Quarter ( in millions) 2.64 3.08 3.74 2.00 4.01 4.57 5.94 3.71 4.84 5.16 6.01 3.96 5.42 5.71 6.75 6.26 7.07 $0 $1 $2 $3 $4 $5 $6 $7 $8 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
11 Consolidated Net Income: Fiscal Quarter (in millions) $0.69 $0.81 $1.31 $0.22 $0.53 $0.97 $1.85 $0.49 $1.11 $1.15 $1.91 $0.79 $1.36 $1.20 $2.08 $1.15 $1.72 $- $0.50 $1.00 $1.50 $2.00 $2.50 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
12 Consolidated Diluted Earnings Per Share $0.04 $0.05 $0.08 $0.01 $0.03 $0.06 $0.11 $0.03 $0.06 $0.07 $0.11 $0.05 $0.08 $0.07 $0.12 $0.06 $0.10 $- $0.02 $0.04 $0.06 $0.08 $0.10 $0.12 $0.14 Q1 Q2 Q3 Q4 Quarterly EPS FY14 FY15 FY16 FY17 FY18
13 Consolidated EBITDA: Fiscal Quarter (in millions) 1.20 1.35 2.30 0.67 1.22 1.97 3.33 1.19 2.22 2.18 3.28 1.51 2.48 2.30 3.60 1.99 3.16 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
14 Cash Position Remains Excellent (in millions) Over $24 million cash paid out over last three FYs $0.5 $0.6 $0.8 $0.8 $0.8 $0.8 $0.8 $0.8 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $1.0 $2.5 $2.1 $0.8 $0.7 $0.8 $1.0 $5.1 $10.1 $10.6 $11.0 $7.8 $8.6 $5.8 $6.1 $6.4 $8.6 $7.2 $7.1 $8.8 $8.0 $8.8 $7.4 $8.2 $6.2 $7.0 $7.5 Dividend Paid Acquisitions Cash on Hand Cash paid to TSRL Cash paid for Cognigen Final cash paid for Cognigen Cash paid for DILIsym (some from Q2 and Q3) Cash paid to TSRL Cash paid to TSRL Final cash paid to TSRL
15 Selected Balance Sheet Items (in millions, except where indicated) November 30, 2017 August 31, 2017 Cash and cash equivalents $ 7.046 * $ 6.216* Cash per share ( in Dollars ) $ 0.41 $ 0.36 Total current assets 13.987 12.668 Total assets 39.750 38.512 Total current liabilities 5.654 2.042 Total liabilities 13.569 12.708 Current ratio 2.47x 6.20x Shareholders’ equity 26.678 25.805 Total liabilities and shareholders’ equity 39.750 38.512 Shareholders’ equity per diluted share ( in Dollars ) $ 1.494 $1.473 * Cash as of January 8, 2018 ~$7.5 million.
16 Lancaster Division John DiBella President, Lancaster Division
17 • Version 9.6 scheduled for January 2018 ‒ New special population physiology models – enhancement to optional add - on module ‒ Improvements to all mechanistic absorption models – enhancement to optional add - on module • Version 9.0 scheduled for May 2018 ‒ Updates to HTPK Simulation Module – new optional add - on module ‒ New capabilities to ADMET Modeler™ Module – enhancement to optional add - on module Software Product News – Lancaster Division • Version 6.0 scheduled for spring 2018 ‒ New long - acting injectable model developed from the FDA grant (expands user base) ‒ New precipitation assay & biphasic dissolution models • Version 2.0 released in September 2017 ‒ New models to analyze data collected from hepatocyte studies (expands user base) ‒ Improved integration with the ADMET Predictor™ Module – optional add - on module • Version 2.0 scheduled for January 2018 ‒ New simulation/prediction options to complement model - fitting routines ‒ Improved user operations to create a ‘plug ‘n play’ environment
1QFY18 Sales Review – Lancaster Division • Revenue +9.4% vs. 1QFY17 • Highlights: – Software revenue +3% • 80% renewal rate (accounts) • 88% renewal rate (fees) • 4% increase in license units • 11 new commercial companies – New domestic customers in India, Japan, and China • 10 new nonprofit groups – Expansion of licenses at China FDA and Health Canada – Consulting & training revenue +66% • 22 companies + 2 FDA collaborations • Workshops in Boston, Tokyo, and Mumbai 68% 16% 13% 3% Revenue Breakdown Renewal New Consulting Training 150 174 225 157 194 201 199 181 190 211 238 195 198 Q1 Q2 Q3 Q4 Software License Units/Quarter FY15 FY16 FY17 FY18 18
1QFY18 Software Revenue – by Region Europe 27% North America 45% Asia 28% South America <1% Japan = 56% China = 23% India = 21% Korea = <1% 19
1QFY18 Marketing Activities Website Content • Increased production of video content for promotional/branding purposes • Increased focus on SEO performance • Continued migration of content from different division sites to main Simulations Plus domain Workshops and Conferences • PBPK workshops held in Boston, Tokyo, and Mumbai • Hosted 7 onsite trainings at individual companies • Attended 14 scientific conferences; delivered 17 poster/podium presentations Strategic Digital Marketing Initiatives • Hosted 3 webinars on modeling & simulation applications • Continued with active social media campaigns – Twitter/LinkedIn/YouTube followers have increased 17% vs. November 2016 – GastroPlus User Group membership increased 10% vs. November 2016 20
21 Re - imagining the Future of Science - based Research and Development Ted Grasela, PharmD , Ph.D. President, Cognigen
Cognigen Growth • Activities supporting continued growth – Successful recruiting and on - boarding of software engineers and scientists – New marketing initiatives and business/sales models – Increasing synergy and cross - selling between divisions – Accelerating KIWI TM development 22
23 Cognigen Status Report Pharmacometric Services • In FY2018 relationships with 21 companies on 34 drugs, 54 projects – 2 new companies in FY2018 – 14 new projects in FY2018 – 8 projects expanded scope in FY2018 – 3 projects with reduced scope – 37 outstanding proposals with 25 different companies • Expansion in global health initiatives, bridging global regulatory submissions, and embedding pharmacometric services from first - in - human to commercialization of new medicines • In FY2018 presented 5 posters, and 3 peer - reviewed publications – Working on 20 publications and 5 conference abstracts • Most common therapeutic area is oncology, followed by neurology, endocrinology, and infectious disease – ~45% of projects result directly in regulatory interaction.
Leading by Example…… 24
25 • Increased Marketing and Sales • Pharmacometric services continue to expand ‒ Healthy pipeline of new projects, including global health initiative projects ‒ Bridging global regulatory filings ‒ Embedded client partner opportunities from first - in - human to commercialization of new medicines • Cross - selling opportunities with Simulations Plus and DILIsym ‒ Creating broader spectrum business models with clients ‒ Expanding scientific synergies across company scientists • KIWI TM Pharmacometric Communication Platform design and deployment accelerating ‒ 1 st stage of hiring completed Cognigen Summary
26 Drug - Induced Liver Injury and Liver Diseases Brett A. Howell, President DILIsym Services, Research Triangle Park, NC
DILIsym Services, Inc. – Our Vision 27 • DILIsym Services, Inc. offers comprehensive program services: – DILIsym software licensing, training, development (DILI - sim Initiative) – DILIsym and NAFLDsym simulation consulting projects – Consulting and data interpretation – in vitro assay experimental design and management “Our vision is safer, effective, more affordable medicines for patients through modeling and simulation.” DILIsym ®
DILIsym Services Fiscal Q1 Sales Review • DILIsym software consulting projects – 17 active consulting projects using our DILIsym software – DILIsym software is focused on helping companies predict drug - induced liver injury probability for drugs and drug candidates – Involve data management and analysis components • NAFLDsym consulting projects – One significant NAFLDsym consulting project, which is allowing for great enhancements of the software’s capabilities for future consulting – NAFLDsym software is focused on helping companies evaluate targets for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH) • DILIsym software licensing – Consortium contracts, which is the vehicle used for DILIsym licensing – Focused on adding new science and features to DILIsym including adaptive immune components, new simulated populations, and advanced integration with GastroPlus – Actively working with FDA to acquire licenses for evaluation 28 17% 70% 13% Revenue Breakdown DILIsym Software DILIsym Projects NAFLDsym Projects
DILIsym Services Software Product News • DILIsym version 7A was released on Monday, January 8 th to DILI - sim consortium members for internal software use – Includes large number of expanded features and exemplar drugs • NAFLDsym development continues through large pharma company sponsorships – Addition of fibrosis and inflammation pathways and additional simulated patients – Available towards end of 2018 for internal consulting use • Finalizing a proposal for development of software focused on drug - induced kidney injury to go alongside our liver related products • Actively working towards increased communication between DILIsym software and GastroPlus 29 DILIsym ®
DILIsym Services Marketing Updates • Planning to give scientific talks, training courses, and/or exhibitions at 6 or more venues in 2018, including several national meetings focused on liver and safety • Jointly marketing with Simulations Plus (Lancaster Division) and Cognigen at most shows • Working towards migration of marketing content to Simulations Plus website for combined marketing presence across all three divisions 30
DILIsym Services Summary • New, enhanced version of flagship product, DILIsym, just released • Active development across multiple products for expanded applications • Continuing to work with Simulations Plus Lancaster and Cognigen on integrative marketing and other synergies • Number of consulting clients continues to grow; now well over 30 companies • Number of DILIsym licensees continues to grow; now 18 major pharmaceutical companies have licensed DILIsym at some point in the history of the consortium, as well as FDA 31
32 Final Summary Walter S. Woltosz CEO and Chairman
33 • 1QFY18 • Revenues up $1.7 million (30.5%) to $7.1 million • Net income up $354,000 (26.0%) to $1.7 million • Diluted earnings per share up 22.8% to 10¢ per share • California, Buffalo, and North Carolina divisions all performing well • Expected synergies being realized • Addressing regulatory agency focus on applying PBPK modeling in clinical pharmacology & safety research • New guidance documents issued by FDA and EMA helping drive interest • Executing on 5 - year, $4.7 million contract with major research foundation • Offers potential for additional such contracts with other organizations • DILIsym Services acquisition expands offerings into systems toxicology • Exciting opportunities to provide end - to - end solutions for clients in different markets • We believe Simulations Plus continues to lead the trend toward greater use of modeling and simulation in research & development Summary
34 Thank you! http://www.simulations - plus.com https://www.linkedin.com/company/95827/ https://www.linkedin.com/company/46152/
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