Simulations Plus (SLP)

[dickmilde]

Our little company is getting bigger.
Simulations Plus to Acquire Cognigen Corporation

Simulations Plus, Inc. (SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that it has entered into an Agreement and Plan of Merger (the “Agreement”) with Cognigen Corporation of Buffalo, New York.

Pursuant to the Agreement, upon closing, Cognigen will become a wholly-owned subsidiary of Simulations Plus and will continue to operate under the Cognigen name. This will result in the total number of Simulations Plus employees increasing from 30 to 65, and is expected to add approximately $5 million to the revenues of the combined company in the coming fiscal year.

Under the terms of the Agreement, Simulations Plus will pay the shareholders of Cognigen total consideration of $7,000,000, comprised of $2,800,000 of cash and $4,200,000 worth of newly-issued, unregistered shares of common stock of Simulations Plus.
http://finance.yahoo.com/news/simulations-plus-acquire-cognigen-corporation-024500276.html

[dickmilde]

SLP Releases ADMET Predictor Version 7.0

After completing the development of the new pKa model, we retrained almost all other predictive models in order to capture the benefit of the more accurate ionization description. This means that our already established lead as the most accurate molecular-structure-to-property prediction program has just been pushed further ahead of the competition.
“ADMET Predictor has been compared to similar software offerings from many other companies in a number of scientific journal articles by independent third parties and has been consistently ranked #1 in predictive accuracy. The extension of the ‘chemical coverage space’ in our pKa model has resulted in an increase in the number of chemical and consumer goods companies requesting evaluations. We anticipate this will help us continue to penetrate these markets
http://finance.yahoo.com/news/simulations-plus-releases-admet-predictor-120000136.html

[The_Free_Nebula]

looking like a great year for SLP

[swampboots]

Yikes they can tweak a goldmine. you the man here!!!!

[dickmilde]

Amazing stuff !

Simulations Plus, Inc. (SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that its second NCE (new chemical entity) initiative, which involved using Simulations Plus software to design molecules to inhibit COX-2, has been a success as determined by synthesis and testing by a third-party lab. Three of the four molecules it has designed are potent inhibitors of both cyclooxygenase-2 (COX-2) and COX-1 enzymes. The fourth inhibits COX-2 but only weakly inhibits COX-1.

Dr. Robert Clark, director of cheminformatics sciences for Simulations Plus, said: “We’re very pleased to report that our second NCE project has again demonstrated that our ADMET Design Suite™ (ADMET Predictor™, MedChem Studio™, and MedChem Designer™, supplemented by GastroPlus™ simulations) provides tools that can rapidly and inexpensively generate new lead molecules with affinity for selected targets. This project was more challenging than the malaria NCE project we completed two years ago because this time our goal was to inhibit two targets with a single molecule while also providing good ADMET (absorption, distribution, metabolism, excretion, and toxicity) properties. Southern Research Institute in Birmingham, Alabama, performed the chemical synthesis and Cerep in Redmond, Washington, performed the COX-2 and COX-1 assays.”

Dr. Michael Lawless, team leader for cheminformatics studies at Simulations Plus, added: “The only COX-2 inhibitor remaining on the U.S. market is Celebrex® (celecoxib), after Vioxx® (rofecoxib) and others were withdrawn for cardiotoxicity side effects. Research after the Vioxx withdrawal indicated that to avoid cardiotoxicity when inhibiting COX-2, it is important to also inhibit COX-1 but to a lesser extent. Needless to say, we’re delighted that we were able to hit two targets with three of four molecules, and one of them is potent as well as having the desired property of higher affinity for COX-2 than for COX-1. The fact that these molecules were designed using only our own software suite is a testament to the capabilities provided by these powerful programs.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “Once again we stuck our necks out and announced prior to synthesis that we were going to contract with a company to synthesize several molecules of our own design and have them tested to see if we were successful. In just a few months, and for a mere fraction of the normal cost required to design new lead molecules to hit one target, we were able to design single molecules that each hit two different targets. This process might take years using traditional methodologies. We are not aware of any other software company that has applied its tools in this way - to take the risk of designing new molecules, having them made, then having them tested, while openly announcing ahead of time and providing results as soon as they were available. There is a chance, although it is probably remote, that we might be able to license one or more of these molecules to a company that could take them forward into further structural refinements and development. However, our goal is not to become a drug company, but to show that our software tools provide very powerful capabilities that can dramatically reduce the time and cost to generate good lead molecules for a wide variety of targets. We plan to present our results at upcoming scientific meetings, to customers at on-site visits, and ultimately, to submit a publication to one of the peer-reviewed scientific journals that cover this area of science.”
http://finance.yahoo.com/news/simulations-plus-announces-success-cox-120000809.html

[silkysullivan]

Thanks dickmilde ... You have been very kind to share this DD ... I think I will take a position soon

[dickmilde]

If you are referring to the 181,000 transaction on 09-25-2012 this was a gift that VIRGINIA WOLTOSZ, the secretary and treasure made to a 3rd party. These shares were not sold they were given as a gift... See the transaction code "G" on the form 4.
http://www.sec.gov/Archives/edgar/data/1023459/000122252712000002/xslF345X03/primary_doc.xml

Mrs. Woltosz has made many stock gifts near year end. She also gifted 160,000 shares on 09-18-2013.
http://www.sec.gov/Archives/edgar/data/1023459/000122252713000001/xslF345X03/primary_doc.xml

Make sure that you get correct information by referring to the SEC web site... Yahoo has mistakes and is very inaccurate in many areas.

[silkysullivan]

I see 181,000 listed as insider selling. Do you know the background of that? Thanks in advance.

[silkysullivan]

Thanks for that excellent information. I think this looks like a solid company, well priced, at the right time. That was me with the member mark. Thanks again.

[dickmilde]

Faruqi & Faruqi is a law office that puts out press releases to see if a share holder will engage with them to file a complaint against any company that they can find. Most companies will "settle" because that is less expensive then going to court.

In this particular case Faruqi & Faruqi is looking for someone that is willing to complain legally that SLP is acting in bad faith by establishing a stock option plan to provide an incentive for their senior employees to continue growing the company. The stock options that SLP provides to the staff are entirely in line with good business practices. As an example with how conservative they are with stock... There have only been 26,000 shares issued for corporate purposes since the IPO many years ago. Yes, there have been more options but the lack of share issuance is a testament to the strong belief that shareholder value should always be protected. Walt holds about 40% of the stock... He has NEVER taken an action that is not in the best interest of those shares.

A law suit might be filed and if SLP decides to contest it in court they would win without question... they have years of history proving their side of the story. But... if it comes to that SLP might also settle because of the expense to defend.

Faruqi & Faruqi is the scum of the low life... They don't protect shareholders they suck money out of corporations for their own gain... They make their living on the "settlements".They do not provide any value.

To answer your question specifically... No, there is nothing to the law suit but, if it happens there will be a one time expense and possibly a hit to the share price. This would be an excellent opportunity to buy additional shares for those that are able to see the bigger picture.

Here is an article on them if you care to learn more...
http://www.forbes.com/sites/danielfisher/2013/03/14/faruqi-faruqis-clouded-reputation-takes-another-hit-with-sex-suit/

[silkysullivan]

Thanks for the insight .. Is there anything to the lawsuit regarding possible dilution?

[dickmilde]

And it's a good place to land!

I've been here since the early 2000's... Since the dot com bust SLP saw a low of .26... That's an increase of 22 X. Anyway, SLP continues to be a larger and larger % of my overall portfolio of stocks. Given the pristine balance sheet and zero debt I will probably continue to hold my shares.

[silkysullivan]

I've landed here based on good fundamentals. Haven't determined yet if there are any pending events to drive a price rise. 10Q April 15 perhaps ...

[econ1]

D ickmilde - until there is very significant news prob will not see posters here.

[dickmilde]

I moderated this board for a while some time back...
The interest on I-Hub is even less than at Yahoo.

[econ1]

Anyone here? Should start back up dialogue here - better than yahoo msg bd. Can post links and monitor for garbage posts.

[Kylef]

Lets take this to $6, promo slp to other boards

[Easymoneyman00]

This stock hasn't moved in over a year! Growth is only on SLP's income not shareholder equity! Check out PCYG now theres a company thats worth investing in do some DD and thats a software company thats turning a lot of hedge fund guy's heads! Stock is around $8 it will be $12 by the end of the years
and $20 by the end of 2014! Just my opinion!

[dickmilde]

Look at the "Events" schedule for June.
http://www.simulations-plus.com/Events.aspx

SLP has a very busy month ahead.. The professional meetings and conferences have always been a good source for new customers. Because the SLP engineers that actually design and write the code for the offerings are presenting at these conferences, scientists that attend these meetings have an opportunity to discuss specific product details that would be difficult for a sales person to address. These one on one discussions are very important to the chemist that is looking for solutions to specific problems... The SLP designer can provide specific feed back regarding product capability and will in many cases gain valuable information on how to improve the SLP offerings.
The busy June schedule should result in continued sales and earnings growth for SLP.

[dickmilde]

Good news...
This is what SLP is all about... Saving time and money for the drug discovery industry.

Simulations Plus Software Used in Regulatory Submittals

Simulations Plus, Inc. (SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that results of simulations using its GastroPlus™ software have been submitted to major regulatory agencies as part of applications by its customers.

John DiBella, vice president of marketing and sales for Simulations Plus, noted, “The first submittal to a regulatory agency was reported by Pfizer in 2008, which resulted in Pfizer being allowed to forego a human trial after GastroPlus simulations showed that it would not be necessary. In the past 12 months, four additional customers have submitted simulation results to the U.S. Food and Drug Administration (FDA), the European Medical Agency (EMA), and the British Medical Health Regulatory Agency (MHRA). Each of these involved a consulting contract with Simulations Plus to assist the sponsor with the GastroPlus simulations and model development. Simulations Plus also provided assistance in preparation of the submittals to the regulatory agencies. The acceptance of simulation results by these agencies is an indication of the growing importance of simulation and modeling technology in pharmaceutical research and development.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “The four submittals John describes resulted in:
1. Eliminating a clinical trial to demonstrate that fasted and fed states would not produce significantly different results for the absorption of the drug candidate.
2. Identifying the particle size specification for a re-engineered product to ensure bioequivalence to an existing product.
3. Explaining the variations observed in different formulations.
4. Scaling complex processes involving metabolism and carrier-mediated transport from adult to pediatric/neonate populations.

These four submissions signal a developing trend for the use of simulation and modeling results to reduce the cost and time to bring new drug products to market. Note that these four involved Simulations Plus consulting services. A number of other submittals have been made by sponsors on their own. Regulatory agencies in the U.S., Europe, China, and Japan all have GastroPlus for their internal use, so sponsors can submit GastroPlus input files to these agencies to make evaluation of results fast and convenient. In time, we believe other sponsors will increasingly utilize powerful simulation software to help streamline the regulatory process and provide regulators with accurate data for evaluation purposes.”

[DoughDiligence]

2nd Quarter Results are released today.

Net profit 6.5 cents beats the 5 cent profit a year ago.

Best Revenue Quarter in company history. Training classes are increasing. New Software releases will be complete soon (April 2013). Membrane Plus module is still under development, to be complete later this year. Cash is accumulating again. 3rd Quarter is looking strong.

http://finance.yahoo.com/news/simulations-plus-reports-second-quarter-200100938.html

Conference Call is available on the company website.

[DoughDiligence]

I found a Sept 2012 Presentation Document by SLP's chief scientist.

http://www.pqri.org/workshops/ivivc/bolgergastroplusfinal.pdf

The title of the document shows up as IVIVCPlus, but there is no official trademark for IVIVCPlus.

[DoughDiligence]

University of Iowa list GastroPlus on list of evaluated software on February 18, 2013.

http://cs.its.uiowa.edu/software/evaluatedlicenseagreements.shtml


GastroPlus Trial Version (2 Weeks)
Vendor: Simulations Plus Inc.
Evaluated 18-Feb-13
Simulations Plus Software License

[DoughDiligence]

I love SLP with Gross Margins over 80% and growing revenues at 12%.

The future is very bright. We haven't heard anything about the Malaria project or the NCE project yet.

[swampboots]

You were so smart to stick with it a 6 bagger with dividens fa ya!!!!

[dickmilde]

SLP Preliminary results for the quarter:
• This was the Company’s 22nd consecutive profitable quarter
• Preliminary revenues increased to $3.117 million, compared to $2.789 million in 2QFY12
• This represents an increase of 11.7% over 2QFY12 and is a new record quarter
• Approximately 18% of revenues came from new software licenses
• Approximately 6.4% of revenues came from consulting studies and collaborations
• Cash as of March 5, 2013 was $10.03 million
http://finance.yahoo.com/news/simulations-plus-reports-preliminary-revenues-130000652.html

[DoughDiligence]

GastroPlus and ADMET Predictor used to predict Alzheimer elements in June 2012 study.

Post study results will be compared to the Prediction made with SLP software.

http://www.page-meeting.org/pdf_assets/4550-Bolger-PAGE-2012_Venice_Allopregnanolone%20PBPK-PD-Model-in-Elderly-POSTER.pdf

[DoughDiligence]

Toxity Webinar from early December on the SLP website.

https://www.simulations-plus.com/images/ToxWebinar.wmv

Also, January conference in Belgium this week.

https://www.simulations-plus.com/events.aspx?eID=3

"Estimated physicochemical properties forecast the unexpected renal failure in phase I testing of SGX523"

[DoughDiligence]

Short-sided investors are the reason for the stock slump.

Too many Investors chase short-term news. Lower 2013 dividends and lack of news on NCE developments are holding the price down a little.

The underlying value of SLP intellectual property is a rare element in the investment world. Investors can't value it correctly, so the don't value it at all.

SLP software applications can change the world in so many ways right now, yet SLP continues to improve the features ahead of their competitors.

The 18 new customers is the big positive out of the CC. If they do that each quarter in 2013, they will have great revenues going forward into 2014. I believe it will happen in Q2 and Q3, probably not in Q4 due to the summer slump in sales.

[swampboots]

Swampboots you are a dummy!!

[swampboots]

You are the unsung hero on SLP, I slipped as swore I would also be united with its destiny as fav fav since listening to CC's but loose mind sinks ships and I sold too soon and bear open wounds.

[dickmilde]

I've been in SLP for a long time... Since early 2000's when it was as low as .23. That would be an 18 bagger

The stock price is very volatile but the sales, stock holder equity and management are very stable and on a long up trend. The recent Q report indicates that SLP was impacted by some industry closures and consolidation. This may be a critical time for Walt to see if he can keep his record intact. He said the consolidation was unique and never seen before and there was no reason to believe that it would continue at the recent pace. I'm holding my shares with the expectation that he is correct and that SLP will continue to grow. The recent introduction of the dividend has a tendency to put a floor under the stock price but since part of the 2013 dividend was paid in 2012 the effective yield will be lower for new investors in 2013. This may be part of the reason for the recent price weakness.

[swampboots]

Nice 4 bagger!

[DoughDiligence]

Here is a 2007 Global Plan for Malaria Research and Applications.

http://www.policycures.org/downloads/The_malaria_product_pipeline_planning_for_the_future.pdf

This PDF gives a great view of the size of the Malaria problem only a few years ago.

[DoughDiligence]

Any guesses on the next NCE project?

West Nile Virus?
Type 2 Diabetes / Insulin Maintenance?
TB?
Early Cancer Detection?
Alzheimer?
Drug Addiction Dependency Solution?

[dickmilde]

Conference call replay on the SLP web site.

http://www.simulations-plus.com/

At the "Investors" pull down select "Conference Call".

[dickmilde]

10Q available at SEC web site...

http://www.sec.gov/Archives/edgar/data/1023459/000101968713000130/simulations_10q-113012.htm

[DoughDiligence]

SLP presents at an Investor Conference today.

http://finance.yahoo.com/news/simulations-plus-present-sidoti-semi-130000117.html

Look at this AMAZING VOLUME - 6.300 shares traded. The presentation must have been really GREAT.

[dickmilde]

Taglich Brothers report update

Key Investment Considerations:
Maintaining Speculative Buy rating. Increasing (12-month) price target to $5.45 from $5.00 per share due to
improved sector valuation.
Profit growth will be driven by gross margin gains stemming from the purchase of a royalty agreement, high
margin simulation software sales, and funded collaborations, which carry a gross margin of over 86%.
Use of software tools and analytics for drug discovery and development is becoming more widespread within
the pharmaceutical and biotechnology industries due to reduced R&D budgets.
SLP has penetrated only 10% of the 1,000+ potential pharmaceutical and biotechnology customers, leaving
ample revenue upside. Toxicology products, release of MembranePlus™ in FY13, and development of a new
chemical entity molecular library could underlie further revenue upside into FY14.
4Q12 income from continuing operations (reported 11-19-12) was $349,000 or $0.02 per share, up from $170,000 or
$0.01 last year, on a 14.9% sales increase to $1.6 million. 4Q12 sales and EPS were in line with our forecast.
Reduced our FY13 EPS projection by $0.03 to $0.19 on sales of $10.3 million (down $500,000). We anticipate
20 fewer new customers (60), a larger scientific team (3), and laboratory experiment expenses for development
of a second new chemical entity that was unanticipated earlier.
In FY14, we project 12.5% sales growth to $11.5 million and EPS of $0.23 per share. After four years of stable
pricing, we anticipate a price increase on software offerings, traction gains by MembranePlus, and a total of
70 (new) customers, up from 60 in FY13 and 43 in FY12.

Full report here:
http://www.taglichbrothers.com/TaglichTrack/Reports/simplus/simplus-12102012.pdf

[DoughDiligence]

FDA Paid $30,135 for 10 GastroPlus 7.0 Licenses in August 2010.

http://www.hhs.gov/grants/fda2010scinventory-c.csv

AJ54,LIFE SCIENCES (ENGINEERING),7524,
FOOD AND DRUG ADMINISTRATION,7500,
"HEALTH AND HUMAN SERVICES, DEPARTMENT OF",7524,
FOOD AND DRUG ADMINISTRATION,LANCASTER,CA,UNITED STATES,
08/31/2010,COMPETED UNDER SAP,,
FIRM FIXED PRICE,
TAS::75 0600::
TAS LICENSING OF GASTROPLUS 7 0 10 LICENSE AGREEMENTS,
"SIMULATIONS PLUS, INC.",HHSF223201011649P,,959691809,
"$30,135.00"

[DoughDiligence]

Aston University (UK) launches a Masters Program in Pharmacokinetics starting September 2013.

http://www1.aston.ac.uk/study/postgraduate/taught-programmes/school/life-health-sciences/msc-pharmacokinetics/

GastroPlus and SimCYP software are included in the 12 month program.

[DoughDiligence]

Gates Foundation Awards $10 mil for TB drug improvements.

http://www.fiercevaccines.com/story/idri-fetches-10m-gates-foundation-adjuvant-research/2012-12-12

Next up, Simulations Plus for Malaria drug improvements.

PS, IDRI needs Simulations Plus software and has the money to pay for it.

[dickmilde]

3 Workshops are scheduled for 2013.

This will generate additional business as new users learn how it all works.

http://www.simulations-plus.com/workshop.aspx?eID=1

[dickmilde]

I'm not an expert chart reader but we may have price support very close to the current level. The price bumped into the 4.20 to 4.25 range many times during June July and August before moving up so there is a fair chance it will not go lower here. Of course any financial event can change all of this in a heart beat... That may be a reason for the recent price weakness... because of the lackluster sales report we got.

[DoughDiligence]

Merry Christmas to all SLP shareholders.

I was hoping to get some low priced shares before that message was posted.

[dickmilde]

Simulations Plus declares accelerated cash dividend of $0.14/share (SLP) 4.28 : Co announced that its board of directors has decided to accelerate a portion of the expected dividend payments for 2013, in light of uncertainty surrounding taxes on dividends. The Board of Directors declared its next ongoing quarterly cash dividend of $0.05 per share.

In addition, the Board of Directors decided to pay a $0.03 per share portion of the intended $0.05 per share dividend for the following three quarters to its shareholders. This accelerated payment will be distributed on Friday, Dec 28, 2012, for shareholders of record as of Monday, December 24, 2012.

[DoughDiligence]

Several recent articles publish in 2012 from SLP scientists.

http://www.simulations-plus.com/Publication.aspx

Several November and October articles. The topics are too complex to discuss easily here.

[DoughDiligence]

March 2013 Boston ADMET Course Description.

http://www.simulations-plus.com/workshop.aspx?eID=1

'This two-day, hands on training course will focus on the use of state-of-the-art cheminformatics and machine-learning software for de novo design and optimization of preclinical candidates that have both good target potency and acceptable ADMET properties. Attendees will be guided through a drug discovery and lead optimization process that begins with high throughput screening data and ends with candidates ready to enter preclinical animal studies.'

I like the sound of this:

'machine-learning software for de novo design and optimization of preclinical candidates'

[DoughDiligence]

How big is the Malaria Infection problem?

'The CDC estimates that there are 300-500 million cases of malaria each year, and more than 1 million people die from it.'

The current drug treatment recommend 48-96 hours of medication at a cost of $2 to $9 depending on the type of malaria and the drugs used.

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001646/

[DoughDiligence]

Maybe Grapefruit lovers are realizing the need for GastroPlus software today.