EX-99.1 2 simulations_8k-ex9901.htm PRESENTATION simulations_8k-ex9901.htm  

Exhibit 99.1
 
Simulations Plus, Inc.
NASDAQ: SLP
First Quarter Fiscal Year 2010
Conference Call
January 13, 2010
 
 

 
Introduction and Welcome
 Introduction and Welcome
 Agenda
  First Quarter FY 2010 (1QFY10) Financial
 Summary
  Progress in Business Units
  Strategy Going Forward
  Questions and Answers
 
 

 
 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; the Company’s
 ability to identify, evaluate, and close suitable acquisitions; 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 Under the
Private Securities Litigation Reform Act
of 1995
 
 

 
1QFY10 (3 months) Financial Summary
 Gross revenues = $2.437 MM (up 14.2% from 1QFY09)
  Pharmaceutical software and services = $1.735 MM (up 21.3% from $1.430 MM in 1QFY09)
  Words+ subsidiary = $702,000 (down 0.1% from $703,000 1QFY09)
 SG&A = $1,004,000 (up 11.1% from $904,000 in 1QFY09)
  SG&A increased due to travel and show expenses, bonuses to officer, and increases in salaries
 and benefits over 1QFY09. As percent of sales, SG&A decreased from 42.4% to 41.2%.
 R&D Expense = $261,000 (down 2.9% from $269,000 from 1QFY09)
  Greater time on contract studies
 Income Before Income Taxes = $661,000 (up 46.0% from $453,000 in 1QFY09)
  Greater pharmaceutical software and services revenues
 Net Income = $430,000 (up 38.0% from $312,000 in 1QFY09)
  High margin on pharmaceutical business results in percentage earnings growth greater than
 percentage revenues growth once breakeven is passed
 EPS = $0.03/FD share (up $0.007 from $0.02/FD share in 1QFY09)
  Positive results continue in spite of global economic crisis
  Share repurchase reduced number of fully diluted shares
 Cash = $7.97 MM (up $1.91 MM or 31.5% from $6.06 MM in 1QFY09)
  Cash increased even with >$1 MM share repurchase program spending over $1 MM in FY09
 Shareholders’ Equity = $10.812 MM (up 4.8% from $10.315 MM in 1QFY09)
  Again, in spite of spending ~$1MM for share repurchases
 
 

 
Share Repurchase Program
 Board of directors authorized share repurchase program for up to
 $2.5 million from October 2008 through October 2009. Actual
 repurchases began December 2, 2008, so the board extended the
 repurchase period through December 1, 2009.
 Total of 1.02 MM shares were bought back at average price per
 share of about $1.32.
 No plans at this time to repurchase shares; however, the board of
 directors may decide to reinstitute repurchasing shares at any
 time.
 
 

 
Progress - 1
 ADMET Predictor™ (Structure-property prediction program)
  Version 4.0 was released in July with new metabolism and toxicity models
  New Dose Optimization Module developed under estimates dose amount
 needed for new molecules based on mini-GastroPlus simulation
  Developed under Pfizer funding and in active use at Pfizer now
  Expanded graphics capability was added with Miner3D component
  Work continues on our $525,000 SBIR Phase II grant with excellent
 progress on advancing the predictions in ADMET Predictor through better
 atomic and molecular descriptors. The rapid partial charge calculations we
 have developed allow calculation of atomic partial charges at the rate of
 hundreds of thousands of molecules per hour rather than one molecule per
 day using traditional quantum methods.
 
 

 
Solubility in Biorelevant Fluids
 During FY09 we funded a series of experiments with Northeastern
 University to measure the solubility of 160 drugs and drug-like compounds
 in three different types of biorelevant fluids:
  Fasted state simulated gastric fluid (FaSGF)
  Fasted state simulated intestinal fluid (FaSSIF)
  Fed state simulated intestinal fluid (FeSSIF)
 These data have been used to build preliminary solubility models for
 ADMET Predictor to provide estimates for
in vivo solubilities for new
 compounds without the need to measure them
 We presented a scientific poster at the American Association of
 Pharmaceutical Scientists meeting in November, which generated very high
 interest from scientists at the meeting
 We will soon offer these data as a new product. We also intend to conduct
 more of these experiments to expand the database and improve our
 predictions. And we are considering funding other types of experiments to
 improve different aspects of our modeling and simulation capabilities.
 
 

 
Progress - 2
 ClassPharmer™ (Data Mining and de novo Molecule Design)
  Numerous improvements were being incorporated during the 4th
 quarter, and Version 4.7 was released in October.
  We continue to enhance ClassPharmer’s capabilities in data mining and
 
de novo molecule design (design of new molecules) and to add
 additional convenience features requested by our users.
  New “scaffold hopping” capability was added in 4.7 - allows chemists
 to change the core (or any portion) of a molecule while maintaining
 other features and the bond distances between them.
  Current efforts are focused on refactoring the code to make it more
 streamlined and efficient, and adding a number of additional
 visualization and user convenience features.
 
 

 
Progress - 3
DDDPlus - Simulates laboratory dissolution experiments
 Sales continue to increase steadily
 Version 3.0 was released in Q3 with a number of important
 enhancements
 Remains the only tool of its kind
 Further development on hold during 1QFY10 to allow
 greater support for contract studies
 
 

 
Progress - 4
 GastroPlus™
  Development of Drug-drug Interaction module continues under funded
 collaboration with Roche - initial capability is now in use at Roche. Full
 capability to be released with Version 7.0.
  Development of ocular delivery capability under a funded collaboration
 with Pfizer is complete - will be released with Version 7.0.
  Development of a nasal-pulmonary delivery module under a funded
 collaboration with GlaxoSmithKline is complete and in use at
 GlaxoSmithKline. Full capability will be released with Version 7.0.
  Consulting contracts continue to come in to assist pharmaceutical
 companies worldwide in analyzing preclinical and clinical data with
 GastroPlus. Multiple contracts currently underway with three top-5
 pharmaceutical companies.
  At AAPS meeting in November, GastroPlus was mentioned by every
 speaker in at least 3 different sessions as the tool used to run the analyses
 that were being presented. One presentation by Novartis noted that
 GastroPlus simulation results submitted to the FDA resulted in the FDA
 agreeing to eliminate a clinical trial that would have otherwise been
 required.
 
 

 
GastroPlus Ocular Delivery - Funded
Collaboration with Pfizer
 
 

 
GastroPlus Pulmonary Delivery - Funded
Collaboration with GlaxoSmithKline
 
 

 
Progress - 5
 Words+ subsidiary
  General economy appears to be affecting this business -
 many states are struggling, and a large percentage of our
 sales come from 3rd-party sources (Medicaid, Medicare,
 schools, state vocational rehabilitation programs, etc.)
  New Conversa™ communication device selling well
  Full-time national sales manager working to improve
 marketing and sales activities and dealer relationships
  Two new employee sales reps added in California during
 2009.
  Significant progress on a new product that includes a
 patent disclosure with IP owned by Words+
 
 

 
Miscellaneous Items
 Potential acquisition we were working on for a number of months did not go
 through - seller decided to go with another buyer. Potential remains to acquire
 software part of the business, which was our primary interest.
 Due diligence currently in progress on three acquisition possibilities for the
 pharmaceutical side of the business.
 Two new Ph.D.s started recently and are making excellent contributions
 already. Another has just accepted our offer and will join the team on March 1.
 Our elite team continues to grow!
 Dr. Robert Clark will join the company on January 19 as Director, Life
 Sciences. Experience as VP of Research of a public pharmaceutical software
 company will provide valuable leadership for the Life Sciences team.
 
 

 
Strategy Going Forward
 Continue to expand product line and services
  Pharmaceutical software and services
  Continue to expand Life Sciences team
  For several new product development projects in our corporate strategic plan
  To increase capacity to conduct consulting studies and funded collaborations
  Seek and complete strategic acquisitions
  Goal is to add both new products & services as well as additional scientific staff
  Negotiations continue at slow pace, but we expect results in 2010
  Continue to examine additional SBIR opportunities
  Words+ subsidiary
  Continue product improvements and more aggressive marketing and sales
  Added staff and new billing software to process prior authorizations and accounts
 receivable more quickly - now collecting old receivables from state Medicaid
 agencies
  Seek SBIR funding opportunities that fit our expertise
 Continue our expanded marketing and sales activities - increasing number
 of conferences and meetings worldwide - lead list is growing
  China appears to be significant potential market for pharmaceutical business
  Two new dealers in China now signed up
  Continue our push into the environmental toxicology area
 
 

 
Additional Factors
 State of the pharmaceutical industry
  Mergers have had no adverse effect on business to date - in fact licenses
 have increased at the larger companies, academic and government
 organizations.
  Large companies continue to adopt in silico (software) technologies in
 various departments, and Simulations Plus software is independently
 ranked as best-in-class.
 Government agencies expanding use (FDA added 10 more GastroPlus
 licenses recently.)
 Smaller companies are recognizing the value of in silico tools as a result
 of the many scientific presentations that are now being presented by our
 customers at meetings around the world.
  Outsourcing of consulting studies is on the rise. We expect to see
 continued growth in this area of business.
 
 

 
Summary
 Simulations Plus financial strength continues
  Excellent cash position that continues to grow
  No debt
 Record first quarter! Strong marketing and sales efforts starting to show
 results
  Pharmaceutical software and services revenues up 21.3% from 1QFY09
  Words+ subsidiary flat for the quarter, but new product developments are expected
 to improve performance of this division in 2010
 Focus is on maintaining best-in-class position in product quality and superior
 customer service in both business units
  Version 7.0 of GastroPlus is expected to generate significant additional interest in this
 industry-leading program
  Internal projects expected to add new products during FY2010
  Price increases and reduced discounts expected to further add to revenues and earnings
 Continue to actively seek strategic acquisitions.
 Slides available by e-mail on request through info@simulations-plus.com
 
 

 
Questions?