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Simulations Plus, Inc. (SLP)

Q1 2018 Earnings Call· Tue, Jan 9, 2018

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Transcript

Operator

Operator

Good afternoon, and happy new year, everyone. It's Tuesday, January 09, 2018 and on behalf of Simulations Plus, I welcome you to our First Quarter Fiscal Year 2018 Financial Results Conference Call and Webinar. Presenting this afternoon will be CEO and Chairman, Walt Woltosz; Chief Financial Officer, John Kneisel; and Division Presidents, John DiBella, Ted Grasela and Brett Howell. An opportunity to ask questions will follow today's presentations. You may send your written question using the questions pane on your control panel or you may use the hand-raising icon on your control panel to ask your question directly. Please be sure to enter the unique audio PIN displayed when you join the call. This call is being recorded for playback at our website, www.simulations-plus.com. Before we begin the presentation, we'll start with our Safe Harbor Statement. 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. Now it’s my pleasure to introduce you to Walt Woltosz, CEO and Chairman of Simulations Plus.

Walt Woltosz

Management

Thanks Renee, and thanks to everyone who's joining our call today to review our first quarter fiscal 2018 results. As a quick overview for anyone who is new to Simulations Plus, we are global provider of software and consulting services for R&D, primarily in the pharmaceutical industry, but also in food, cosmetics and general chemical. We in the pharmaceutical research area, we go from the earliest drug discovery when a chemist first draws a molecule or perhaps use a computer program to create a million brand-new molecules that have never existed and hopes that something might become a drug. We go on through preclinical development, lab work and animal work and through the first in human trials on to safety research and assessment on to Phase 2 and Phase 3 clinical trials beyond patent life to supporting generic companies post patent and also become involved in integration of data from multinational R&D efforts through our coverage and division in Buffalo. For the first quarter, very good quarter, revenues up $1.7 million, just over 30% to $7.1 million, net income up $354,000 or 26% to $1.7 million. Nice increase due to very good performance of our Cognigen division and the addition of the DILIsym Services division and Research Triangle Park, North Carolina. So, this is the first quarter where we've had all three divisions; DILIsym was acquired in last summer's fourth quarter, but this is the first full fiscal year now that we will have all three divisions. Diluted earnings per share up 22.8% to $0.10 per share. Software renewal rates about 80% based on number of accounts were 88% on fees. We have small account, sometimes academic accounts that rotate in and out as graduate students move on, but fees are a better indicator of the actual commercial side of…

John Kneisel

Management

All right. Thank you, Walt. You can go to the first slide, our consolidated revenues like Walt said were up by 30.5% or $1.7 million in the first quarter. Lancaster was up $346,000, that was about a 9%, just over 9% increase to $4 million. Buffalo was up 11%, the increase to $1.9 million and North Carolina brought in $1.1 million just over $1.1 million for the quarter. Again, as Walt said, that they were acquired in June of '17 and they were a part of the prior year numbers here. So, again our consolidated software and software sales were up 10% in the quarter and consulting was the remainder of the increase. The cost of revenues in the quarter increased about $400,000. $262,000 of that increase was labor related, $139,000 of that were labor from DILIsym. The remainder was increases in labor from labor count at the other two divisions along with increases in stock-based compensation and cost of training related expenses and other amortization expenses that increased from the acquisition of DILIsym. As overall our cost of revenue as a percentage of revenue actually remained fairly constant. It was just about 0.1% change for the period. Overall our gross margin increased $1.3 million or about 3.6% to about $5.3 million in the period. Over the prior year, $318,000 of that increase came from California, which showed an 82.4% margin. Buffalo division increased to $139,000 or 13% with margins of 63% and DILIsym showed $794,000 in the period with a 71% margin. If you were to look at the prior quarter, their margins were a little lower and that's because our North Carolina in that quarter had a lot more contracts that had a lot of labor or lab testing in the quarter, which tends toward a lower margin.…

John DiBella

Management

Okay. Thank you, John and happy new year to everyone on the call. Diving deeper into the products that Walt described earlier, our software development team in Lancaster is working very hard on new releases of all programs. The next version of GastroPlus, the flagship PBPK modeling platform is set for release over the next month. This version has really something for everyone, including new population models for clinical pharmacology departments and enhancements to our mechanistic absorption models for pharmaceutical scientists. These and other enhancements should really help us expand the types of consulting support we can provide and also help us further penetrate into the clinical space with GastroPlus. ADMET Predictor Version 9 will be released this spring over the next few months. We've received extremely positive feedback on the redesigned HTPK simulation module, which is an optional add-on feature that was part of the ADMET Predictor Version 8.5 released in November and our plans are to continue to add functionality to this module along with a few additional enhancements to other features, really with the goal of getting PBPK modeling into the hands of chemist to more efficiently select lead molecules and help with lead optimizations activities. We released MembranePlus Version 2 in September and expect to release DDDPlus Version 6 in early spring 2018. These in vitro simulation tools really help inform the inputs for GastroPlus PBPK model and we expect the new features coming in DDDPlus and probably towards the end of the year with MembranePlus to continue to help lead growth in their sales. And finally, PKPlus Version 2 is slightly delayed, but will be released this month. The new items been implemented come directly from user feedback and we are really excited to get this next release into the hands of scientists or looking…

Ted Grasela

Management

Thank you, John. John Kneisel had talked about our financial performance and I thought what I would do this afternoon is talk a little bit about what's going on behind the scenes to make that happen. So, we've been really focused on continuing to grow the Cognigen division, both in terms of consulting revenue and also enhancements to the KIWI platform and I'll talk about those in a moment, but we've been successful at recruiting and on boarding a number of software engineers that we need to continue to work with the KIWI platform and that's funded by the approximate five-year long research funding that we have from a foundation. We've also brought on a number of scientists including some senior scientists that are really able to get up to speed very quickly and start working on projects. We've had a number of new marketing initiatives and we're experimenting with different business and sales models and I'll talk a little bit about those in a moment. But we also recognized and want to be just congratulating all the scientists across the divisions for looking for opportunities to cross-sell our products, finding synergy in terms of the scientific expertise that resides across the company and helping to helping these cross-selling opportunities to fruition. And again, we're now because of onboarding the software engineers are able to continue to accelerate the KIWI development actually. So just in terms of consulting services, in 2018 so far, we have relationships with 21 companies and we're working on 34 drugs, a total of 54 projects. So far, we have two new companies that we hadn’t worked with before in this fiscal year. We have 14 new projects that we're brand-new and just started. In projects that had an expanded scope because of the success that…

Brett Howell

Management

Okay. Thank you, Ted and again echoing what's been said already happy new year to everyone. So, I want to start out on the next slide, slide orienting everyone to what we do at DILIsym Services, especially given our position and the new group in the company. So not everyone may be familiar, so our vision really, our focus is safer and more effective management through modeling and simulation and a very synergistic fit with both Cognigen and the Lancaster Division. We offer comprehensive program services that focuses on software licensing and training as well as, as you'll see we're working our revenue breakdown large amount on the consulting projects. As a part of our consulting, we not only do modeling simulation but we also do data, study design and data interpretation and also consulting for companies on an hourly basis in some cases related to regulatory submissions. The two pieces of software that I'll discuss today that you'll hear about is DILIsym. This is focused on the prediction and the understanding of drug induced liver injury and then NAFLDsym, this is focused on the prediction of the efficacy of drugs or the effectiveness of drugs at treating nonalcoholic fatty liver disease or NASH, nonalcoholic steatohepatitis. Next slide please. So just a few notes about our first Q1 with the company and on the breakdown of our revenue. In terms of our software consulting projects, you can see that the DILIsym software and the projects associated with that software in green made up a bulk of our revenue around 70%. We currently have 17 active consulting projects ongoing. Again, this software focuses on helping companies predict problems they may have, which produce liver injury and also help them understand scenarios where they’ve already observed some sort of a problem. This…

Walt Woltosz

Management

Thank you, Brett, Ted, John D, John K. So final summary just to wrap it up, first quarter, very good quarter. Revenues up 30.5%, income up 26%, diluted earnings per share up 22.8%, all three divisions performing very well, the synergies that we expected between divisions are being realized and expanded. We are addressing regulatory agency focus on applied PBPK model in clinical pharmacology and safety research and there are some new guidance document appreciated by the Food and Drug Administration and the European Medical Agency that are helping drive interest. Just before the acquisition of Cognigen in 2014 both the FDA and the MHRA in England, hosted full day meeting specifically focused on applying physiologically-based pharmacokinetic or PBPK modeling in clinical pharmacology. And so, the timing couldn't have been better for us because just a few months later, we were combined together to be able to help push PBPK into clinical pharmacology. We now have scientists at Cognigen who are experts at using PBPK modeling and working with the Lancaster team. You can see the result in the consulting group, the growth in consulting contracts that have come in, partially due to that. We are executing well on a five-year, just under $5 million contract with a major research foundation on malaria and we believe that this offers the potential for additional contracts with other organizations or with other diseases besides malaria. Our DILIsym Services acquisition, an exciting development in the past calendar year, expands our offerings into systems toxicology where there we were looking at what's going on inside of cells with complex networks that take place that involve what's called quantitative systems pharmacology or toxicology. So, we think combined with the PBPK, with the clinical trial data analysis at Cognigen the QSP analysis at DILIsym Services that we do continue to lead the trend towards greater use of modeling and simulation and pharmaceutical research and development and I always like to say what we sell as much as anything is productivity. If you can model something in software and avoid clinical trials, avoid in vitro work, avoid animal tests or at least guide them to be run more efficiently, the payback is tremendous. So, I think the leverage that we have through in cynical modeling and simulation is very high and I expect to see the growth continuous as we've seen in the past. With that, I am going to turn it back over to Renee to moderate the questions.

Q - Renee Bouche

Management

Thank you, Walt. The first couple of questions I think will go to John Kneisel. The first concerns the income statement, which is showing some interest expense. What is that related to and will it continue in future quarters?

John Kneisel

Management

Yeah, I think I may have answered that during the call, but that is related to the acquisition and that is imputed interest on the fair value of the liabilities we needed to estimate what we think the liabilities were and there were some just -- there was some discounting. So that's the interest that is associated with that liability.

Renee Bouche

Management

Okay. The next question is the new tax law. Do you anticipate any impact from it and if so, what?

John Kneisel

Management

Well it's quite early on the tax law. We're a fiscal year filer. It will not affect our current tax return this year, but will affect some of our deferred taxes. We have been discussing the impacts of that with our tax advisers and looking into them, but I can't really say anything about that yet until we go through it. It's just barely being dry on the paper and Congress. So, we'll be looking into that and posting an adjustment when we perhaps have a chance to really look at all the actual components of the tax law.

Walt Woltosz

Management

Just to make sure people understand what you said, when you said it won't affect this year, what you're referring to is the calendar year 2017 correct?

John Kneisel

Management

No, what I'm talking about, our current tax year returns filed for 8/31/18 will not be affected by the tax rate change that occurred in it. It's for the -- tax law affects the tax filings in 2018 for corporate tax return. However, it will affect deferred taxes for our current year because that's on a forward-looking basis, but we have to look at the components of the deferred taxes and assess each one of those and until we've got a chance to look at those, I can't really say what's going to happen to our deferred taxes. We have a lot of deferred tax liability on the books. So, we have to look at each one of the components of that before we can assess it and make any kind of a statement or adjustment in the financials.

Walt Woltosz

Management

Okay. Now I'm confused. We pay taxes on a calendar year bases, right?

John Kneisel

Management

Yes, but we post our income taxes of -- component of our income taxes is deferred income taxes and those look to the future effects of the timing differences associated with the future tax effects of those timing differences and that is what will be affected. Right now, I can't tell what those are without reviewing the whole entire tax package because Congress makes changes to things and we haven't even had a chance to read through the whole act.

Walt Woltosz

Management

Okay. Right I hope you understand it better than I do.

John Kneisel

Management

More to come.

Renee Bouche

Management

Okay. The next question I think we have quite a bit of detail in the presentation, but perhaps more can be said. Can you provide some additional color regarding our consulting pipeline in terms of level of sophistication, potential value and number of projects being worked on as well as bidding on?

Walt Woltosz

Management

John D, you want to take that one?

John DiBella

Management

I'm happy to start and then I'll invite Ted and Brett to also comment as well because I really only have details on the Lancaster Division. Lancaster Division, we're currently working on 24 projects with bids out for another eight today and fees typically for us on projects are going to range from around $50,000 going up $150 K or more depending upon additional modeling tasks that are being added as we proceed. The PBPK modeling projects themselves they usually bring together scientists from a number of departments within a company not ours, but our client has data requirements for the models are extensive and our ability to communicate results back to the company, to our clients requires a certain level of expertise. And as Walt presented in one of the first slides today, the types of projects that we can work on with PBPK modeling approach is really span the preclinical and clinical development phases and we are starting to see a number of projects with companies where we started working with them to address some very specific questions and now this project had expanded as we've gone forward and identified a number of additional needs that have to be addressed. And so, I think that's really where there's a lot of excitement right now for us is the ability to identify additional areas within a company where our modeling and simulation solutions can help. Ted or Brett if you wanted to add anything else.

Brett Howell

Management

Sorry, I was on mute.

Walt Woltosz

Management

Go ahead Brett. Please go ahead.

Brett Howell

Management

Sure. I'll start and then you can finish up. Just a couple of comment with respect to the DILIsym division on the consulting side. I mentioned we have 17 ongoing consulting projects. We have depending on how you define, anticipate, in terms of the level of concreteness of the bid or the level of detail with which you come with the client in terms of getting through the finish line and how they enact the contract. We had somewhere between let's say three and 10 proposals or probably more like three to 15 proposals where we've discussed or put together written proposals for clients for future projects and the value of our contracts typically ranges from 50,000 or 25,000 or just 500,000 depending on the size or larger in some cases and so obviously it's a lot of variables there. I will say that with respect to our consulting for DILIsym because of the nature of those projects is safety related, it's not uncommon for us to have projects pop up very urgent immediate projects that come up and all of a sudden are active and are really short notice. Ted?

Ted Grasela

Management

Yeah, just to say that an important part of our value proposition is the fact that once we start working with client we worked very hard to make sure that we stay involved with the compound over the course of the research and development lifecycle. So, as I mentioned when I was talking about our status of the pharmacometric services, we had eight projects that expanded scope in 2018 and that reflects the fact that the drug has seen positive results and we're continuing again work with those compounds. So, it's a continuing effort to service the projects that we currently have and continue to develop those relationships, while at the same time, finding new clients that we can be working with and as I mentioned, right now we have 37 outstanding proposals with 25 different companies. Some of them are new, some of them are companies that we've already worked with, but we haven't been working with a particular drug. So overall, I would say that we have a very robust pipeline if you are looking for color.

Renee Bouche

Management

Thank you, Ted. The next question is concerning artificial intelligence. There was a recent report from the BBC that researchers in Oxford Hospital have developed artificial intelligence that can diagnose cancer, heart disease and lung cancer. What progress is being made with our AI potential including MRI modeler?

Walt Woltosz

Management

Okay. I guess that's one for me. We have had to put that project on hold until we can finish the PKPlus Version 2, which John DiBella mentioned. We expect to have what released this month. We have made some advances in prototyping, a deep learning capability last summer, but again we had to apply the resources to get this new version of PKPlus out, which we deemed is a higher priority. I'm very excited about artificial intelligence and I'm seeing more and more articles about the use of it in pharmaceutical research, in image processing we did a few years ago with our -- I'll call it shallow learning type of artificial intelligence. We did some work on interpreting magnetic resonance imaging data for either healthy subjects or those with some form of autism spectrum disorder and we're quite successful compared to the published results at that time and being able to classify subjects based on the imaging data as either healthy or likely to be experiencing one of the forms of autism spectrum disorder. Image recognition, facial recognition, complex problems like that are areas where deep learning has been imminently successful and so we did want to expand our capabilities to go to deep learning. And what I mean by that is neural networks that contain more than one layer of neurons between the inputs and the output. I guess a little technical, but we do have that capability prototyped and saw some modest improvements in prediction of properties of molecules, but truthfully the datasets that we use in that type of work are quite small compared to the richness of data that you see like facial recognition or image processing types of problems. So, we're excited that we have this expanded capability, but we have had to put it on hold and hopefully during this calendar year, we're going to see some more work in that area.

Renee Bouche

Management

Okay. Thank you, Walt. The next question, in terms of annual renewal fees, is the upper 80 percentile a good percentage for modeling purposes?

John Kneisel

Management

I'll take this one. Renewal rates in terms of accounts and fees that have been seen in the last two quarters, I think are anomalies. I believe we'll settle back to our normal historical averages in the low to mid-90% rate going forward unless something completely unexpected happens.

Renee Bouche

Management

Okay. Thank you, John. The next question is concerning DILIsym's revenue. 83% of DILIsym's revenue this quarter came from consulting projects. To what degree is this consulting revenue recurring from quarter to quarter?

Walt Woltosz

Management

Brett, that's for you.

Brett Howell

Management

Can you address that and then John Kneisel can also want to jump in, make comments as well feel free, but most of our consulting revenue is in the timeframe of three to eight months in project duration. So most of that consulting revenue is turned over each year. There are a few projects that are more than 12 months in length, but none of that consulting revenue is equivalent to a renewal fee and software. So those fees are nonrecurring, rather they're picked up during new clients and/or additional projects. There are a lot of companies as Ted mentioned that as we'll expand the scope of a project or move to a new project with the same company and in that way some of that ends up being effectively recurring, but those are under new contracts.

Renee Bouche

Management

As a follow-on to that, there is another question concerning the consulting projects. Regarding the 24 current consulting projects at Lancaster and 17 current consulting projects at DILIsym, what's the average expected time remaining on these projects and how much of these consulting revenues are comprised as hourly billings?

John Kneisel

Management

I'll start with Lancaster, average time remaining on the projects today are probably 6 to 10 weeks or so and the number of these projects that are hourly billing is very small. These projects are typically priced following a fixed-price milestone-based proposal model.

Walt Woltosz

Management

And my answers are not significantly different. So, it's probably the average time left is in the range of 8 to 16 weeks, two to four months and the hour and the percentage of the contracts that are hourly is less than -- although we're all over a time period historical period of our revenue over less than 1%. So almost every contract is fixed in nature.

Ted Grasela

Management

We're not out of the norm, correct John?

John Kneisel

Management

However, not out of the norm for what we've seen historically, but like we've said in longer-term projects.

Ted Grasela

Management

Right, exactly, yeah.

Renee Bouche

Management

And we have a question concerning the expected tax rates? What is the expected tax rate for financial reporting purposes in fiscal 2018 and also fiscal 2019, John?

John Kneisel

Management

Yeah currently, with the change in the tax act, it's a little hard to say where that's actually going to go without the ultimate analysis, without the change in the tax act stated by maintaining the historical trends that we've seen. But like I said with the changes until we get through the whole analysis, I can't quite really give any kind of guidance as to where that's going to go.

Renee Bouche

Management

The next question I think is back to John DiBella, what were the anomalies that caused the lower renewal rate and what caused them?

John DiBella

Management

Yeah, there were a number of large pharmaceutical companies that closed sites for one reason or another, I think for most of those companies that is now completed and our licensing model is one in which most of the companies today are still accessing our software through a site-based licensing model. So, these large multinational companies will have licenses and full first user license fees paid at each of these different sites. And so, when one closes that hits us, but what tends to happen is a number of those scientists will then relocate to one of the other sites, will see an increase in the volume of licenses at the sites that remain open. And also, a number of these companies now are starting to evaluate true global license plans and I think that will only help with renewal revenues going forward if we can migrate a lot of these companies over to a more global license model.

Renee Bouche

Management

Okay. Thank you, John. Walt, I don't see any additional questions.

Walt Woltosz

Management

Okay. Well, very good set of questions. I am going to try to understand how this tax thing works myself. Where supposedly taxes are going down but really, it's not all that straightforward to at least determine a rough estimate of how much that might be. But very successful first quarter. Things are firing on all cylinders and we look forward to a very good fiscal year 2018. So, I'll turn it back to Renee to close out the conference call

Renee Bouche

Management

Thank you, everyone for the excellent presentation. This concludes today's conference call and webinar. If you missed any part of today's presentation, the replay will be available at our website, www.simulations-plus.com. Thank you all for joining us today and have a splendid afternoon.