On behalf of the entire Simulations Plus management team, I want to welcome you to the Simulations Plus 2023 Investor Day. Before we begin, I'd like to cover a few housekeeping items. The runtime for today's event will be approximately two hours, with a little over one and a half hours of prepared remarks, followed by a Q&A session. We have a full agenda for you today with presentations from our leadership team. Our speakers today are Shawn O'Connor, Chief Executive Officer of Simulations Plus, who will lead off with a comprehensive update of the business and strategy. Following Shawn, each of the business unit presidents will cover our solutions following the drug development process, going over the key drivers for their unit, how they win, how they partner with clients, and their vision for future growth.
First, we'll hear from John DiBella, President of Physiologically Based Pharmacokinetic Solutions, or better known as PBPK and Cheminformatics. Then we'll hear from Jill Fiedler-Kelly and Jonathan Chauvin, Presidents of the Clinical Pharmacology and Pharmacometrics, or the CPP business unit. Next will be Brett Howell, President of Quantitative Systems Pharmacology, also referred to as QSP. John DiBella will return to discuss regulatory strategy solutions. Josh Fowler, Vice President of Business Development, will discuss sales, strategy, and approach. Shawn O'Connor will then return to discuss M&A strategy and will be joined by Steve Cheng, President of Immunetrics, who will share an update on the integration of that business. Will Frederick, Chief Financial Officer, will then provide strategic targets, fiscal 2024 guidance, and discuss the company's ESG initiatives. We will then move to Q&A before Shawn O'Connor wraps up with closing remarks.
As a reminder, the information discussed today may include forward-looking statements that involve risks and uncertainties. Words like believe, expect, and anticipates refer to our best estimates of this call, and there can be no assurances that these will actually take place. So our actual future results could differ significantly from these statements. 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. With that said, I will turn the call over to Chief Executive Officer, Shawn O'Connor. Shawn?
Thank you, Tamara. Welcome to our inaugural Simulations Plus Investor Day. I'm thrilled that so many of you have been able to join us today. These are exciting times for us as we pursue novel and creative solutions in biosimulation with the goal of improving health outcomes throughout-- through innovative solutions. I'm especially excited for you to hear directly from our talented leadership team, who live our mission to improve health through innovative solutions every day. For those of you who are newer to our story, Simulations Plus has been building a suite of modeling and simulation tools since our founding in 1996. Fortunately, right from the start, we had some very smart people who recognized the potential of artificial intelligence, and Simulations Plus became an early adopter for AI for advanced analytics.
With our AI and machine learning capabilities, we develop advanced software for modeling and simulation, as well as providing consulting services to help our clients effectively deploy our software. Throughout today's prepared remarks, you'll hear how putting our clients first drives growth and innovation, and how this single focus drives these key messages. We have a long history of innovation in biosimulation that is transforming drug development and R&D. We have a rich future of growth opportunities. We have a highly experienced scientific leadership team and are aligned to meet our clients' needs and demands for the future. We have a strong financial position to fund our growth. Over the past 25 years, we have made increasing investments in R&D to support the mission-critical need for patient safety by helping our clients deliver the right drug to the right patient at the right dose.
Our clients are large and small pharmaceutical, biotechnology, chemical, consumer goods companies, and regulatory agencies worldwide. We're very proud to partner with organizations that touch the lives of so many people in so many ways, and we create value for them by accelerating their R&D cycles while reducing costs through innovative science-based software and consulting solutions. Our objective is to help our clients invest in drugs that can be developed faster and cheaper and launched more successfully into the market to address healthcare needs. Our model-informed drug development, or MIDD solutions, span five areas of scientific domain: cheminformatics, physiologically based pharmacokinetic solutions or PBPK, quantitative systems pharmacology or QSP, clinical pharmacology and pharmacometrics or CPP, and regulatory services.
As such, we offer end-to-end solutions across the development cycle. Today, our goal is to give you a better understanding of our expertise and capabilities in each of these scientific domains, future developments, and directions, and how we deliver value to our clients. Putting clients first drives growth and innovation. The harsh economics of drug development is the main catalyst for our industry's continued growth. Drug developers and regulators around the world are adopting biosimulation solutions to improve candidate selection, to accelerate clinical development, and to gain regulatory approval more efficiently. The drug development industry is comprised of pharmaceutical and biotech companies that together spend over $200 billion annually, and this spend is growing at a 3% rate.
According to research studies, the biosimulation market was estimated to be $2.8 billion as of 2022, and is expected to expand at a 16.9% CAGR, reaching nearly $10 billion by 2030. The biosimulation market is growing 4-5x faster than the spend rate in drug development, indicating that more and more dollars are being allocated to modeling and simulation. Why is that? Drug development is complex, expensive, and time intensive. The median cost of developing a new drug is approximately $1.5 billion, and the timeline can range from 10-15 years. Biosimulation makes drug development process safer and more efficient, as well as more economically feasible. For this reason, we are seeing greater acceptance of biosimulation by both industry and regulators as they see the value of modeling and simulation techniques.
That said, there may be some years when spending on biosimulation software is slower than others, as we have seen this past year, when pharmaceutical industry, and like other industries, have reduced its capital spend due to macroeconomic conditions and a constrained capital market. However, over the long term, secular trends remain strong for the increased adoption of biosimulation by pharma, biotech, and regulatory clients. We compete with other companies operating in the biosimulation space. However, there is no single competitor that can provide the broad array of comprehensive biosimulation, modeling, and simulation software solutions, combined with the consulting services that span the drug development process like we do. In our market, we occupy a unique space with a wide portfolio of solutions, more than 25 years of AI and machine learning capabilities, and proven success with our models.
Speaking of which, artificial intelligence, machine learning, deep learning, generative AI, the promise, funding, and general attention on the potential for AI approaches to impact the world of drug development is on everyone's radar. Just as AI is a complex technology, its impact on the science and process of drug development is also complex and multifaceted. A few guide rails as to how we view AI here at SLP. We have been utilizing AI techniques and approaches in our solutions since our beginning. As AI technologies have evolved, we have enhanced our AI solutions and experienced the benefits that can be harnessed with better data access, algorithm training, and predictive accuracy. As with all predictive data analytics, data is key. Our tenure in serving the drug development industry has provided significant access to private and public data necessary to perfect and refine predictive algorithms.
Our partnerships and collaborations with industry leaders and regulatory agencies is unmatched and provides us with ongoing means to continue this into the future. The best example of this is our AI-based predictive capabilities in ADMET Predictor, and specifically areas such as pKa predictions, where we are the recognized leader in this space. AI enhancements that improve data analytics are a component of each of our scientific domains, with improvements planned into the future to enhance, not just in the space of cheminformatics, but used to improve pharmacometrics, PBPK, as well as QSP modeling techniques. AI can improve the value and accuracy of each of these modeling approaches, not just by refining algorithms, but by improving data search, discovery, and understanding speed of model enhancement, solution training, and report generation. The use of 'improve' here is important.
AI will improve, but not displace, the value driven by the use of pharmacometrics or PBPK or QSP in the drug development process. Unless, of course, you believe the AI algorithm is going to identify the molecule in discovery and all of the follow-on clinical development activities are going to be rendered unnecessary. I don't think anyone envisions this to be the outcome. We have seen an abundance of AI startups funded in the drug development space. Some narrowly focused successes have been seen. Most recently, we have seen a number of these startups rein in their aspirations. We have observed the majority, if not all, become drug development companies and not service providers to the industry. We have embraced many of these AI startups as clients.
Again, endorsing the value of our AI technologies where they have application, and as well, reflecting the ongoing value of the traditional MIDD software and service solutions utilized in the clinical drug development process. So, in the end, we embrace the excitement and potential improvements that AI can and will bring to drug development, and we have and will continue to utilize AI technologies to enhance our products and services. Our strategic objectives for fiscal 2024 include: maintain our leadership in MIDD, expand our product and services through strategic internal investment and partnerships with industry and regulatory agencies, pursue strategic acquisitions to expand our TAM, grow at or above market growth, and grow profitably at or above top line growth. Today, we will dive a bit deeper into our businesses to provide you visibility to how we are working to deliver on these objectives.
Before I turn the meeting over to our business unit presidents, I'd like to review our new organizational structure that better aligns us with our clients. This new structure is an important step forward to facilitate the future growth and leadership in our scientific domains by improving the client experience, while encouraging them to move up the value chain. Over the years, we've expanded our business through accretive acquisitions. As you might expect, brand identities linger in the marketplace, but building a culture of collaboration is key to unlocking integration value. Our reorganization reflects the spirit of collaboration that is taking place throughout our organization, and our objective to operate as one company and advance our internal alignment with our clients' needs as we transition our company from acquisition-based divisions to strategic business units defined by our areas of scientific expertise.
As you can see on the left side of the organization chart, we now have five business units, with our brand offerings in each scientific domain. These business units are united by our drive to serve our clients, follow the model-informed drug development process, and our vision, mission, and values. Our reorganization is designed to encourage cross-selling opportunities and streamline redundancies, and align our organization with how our clients use and acquire our solutions and their buying practices. We believe our new organizational structure will have a significant impact internally, as well as positively affect our go-to-market strategy as one cohesive partner to our clients.
Many of you have heard me tell our story, and today you'll hear directly from the leaders of each business unit, who provide a deeper understanding about the exciting developments here, why our clients choose to partner with us, and the bright future of our business. The leadership team all bring deep domain expertise and experience in their areas of responsibility. They include some that have been with the mothership of Simulations Plus from the beginning. They include leadership that has continued with our acquired companies through the years. What they share is the same passion for growing the business and leading their immensely talented teams to innovate and collaborate on the mission-critical work they are doing to bring safe and efficacious drugs to market. Now, we'd like to show a short video that I think provides a great overview of Simulations Plus.
Following that video, you'll hear from John DiBella, President of our PBPK, Cheminformatics, and Regulatory Strategy business unit.
At Simulations Plus, our mission is to support our customers in accelerating their development timelines while reducing the cost of R&D with our science-based biosimulation software and consulting solutions. Our solutions help customers provide new treatment options and products, optimize existing ones, and improve patient and customer lives. During early drug discovery, clients use our AI and machine learning technologies in the ADMET Predictor platform to identify and design molecules predicted to be effective against a targeted disease state and have the right combination of properties to become a drug. Our experts can provide consulting services to support the design process and to ensure the top candidates are patentable and can be easily made or synthesized. Once candidate molecules are selected for further development, we offer physiologically based pharmacokinetic modeling, or PBPK.
Whether clients use our flagship GastroPlus software platform or engage our scientists for support, they gain insight into how a drug behaves across virtual animal and human models. We can predict drug-drug interactions, the extent of absorption from administration all around the body, the local and systemic exposure for small and large molecules, and more. These mechanistic simulations help our clients focus their research and design their clinical trials for a higher likelihood of success. Another critical component of drug development is the efficacy and safety of new treatments. Our quantitative systems pharmacology, or QSP, models and consulting services help clients predict how effective therapies will be in a variety of populations. We can also predict if those therapies will produce toxicity that could endanger patients before a clinical trial begins, increasing the safety of patients and the efficiency of our clients' trials.
Finding a compound effective against its target is only part of the battle. Our clients also need to identify the right dose for the right patients. With our MonolixSuite platform, users can easily perform population pharmacokinetic and pharmacodynamic modeling, exposure response analyses, and simulations of clinical trials to predict next phase outcomes, and to optimize and reduce risk in their study designs and development plans. Clients who need experienced strategic guidance for clinical pharmacology development issues and quantitative support for dose selection and justification can rely on our consultants to help provide confidence for decision-making and regulatory submissions. Once a client has developed a drug and is confident in its efficacy, safety, dosing, and commercial viability, it must be submitted for regulatory review.
We provide advisory support for those submissions by helping develop detailed analysis plans and reports that are designed to answer common questions posed by regulatory agencies during review, reducing the need for further work and increasing the speed to market. Let's accelerate tomorrow's treatments together.
Hello, hello, everyone. My name is John DiBella, and I serve as the president of the Cheminformatics, PBPK, and Regulatory Strategies business units. Following that excellent video, I'm very happy to kick off the business unit discussions by spending the next few minutes presenting on our offerings in the Cheminformatics and PBPK scientific domains. During my 20 years with Simulations Plus, I have worked on the development of many things, including GastroPlus and DDDPlus software and consulting projects. I have a BS and MS in Biomedical Engineering from Case Western Reserve University, and have published, conducted webinars, delivered presentations on various topics, including PBPK modeling. It goes without saying, but I will anyway, our Cheminformatics and PBPK teams are recognized thought leaders and extremely talented. Our Cheminformatics business unit specializes in the development of cutting-edge computational chemistry solutions and artificial intelligence, machine learning technologies to aid in drug discovery.
Cheminformatics refers to the use of physical chemistry with computer and information science techniques, or so-called in silico techniques. These in silico techniques are used by our clients, like pharmaceutical and biotechnology companies, to aid and inform drug discovery. Our flagship product is ADMET Predictor, which is a comprehensive cheminformatics software platform that can be used for a wide range of tasks, including ADMET prediction, where we can predict a spectrum of absorption, distribution, metabolism, elimination, and toxicity properties, including pKa, solubility pH, logD/pH, metabolism, and inhibition kinetics, Ames mutagenicity, and more. Molecule design and optimization, where we utilize our state-of-the-art AI-driven drug design platform within ADMET Predictor to integrate our advanced generative chemistry algorithms with our best-in-class high-throughput PBPK simulations and ADMET property predictions to deliver novel molecules that are active and lead-like.
Also, virtual screening, where we can build virtual compound libraries for a company's target of interest and analyze the results from high-throughput screens to guide further evolution of those lead molecules. We also have a team of experts, including biologists, computational and medicinal chemists, and data scientists who provide end-to-end drug design and optimization consulting support utilizing in silico approaches. Some of the highlights for Cheminformatics in fiscal 2023 include: we have over 80 companies globally which are licensing the ADMET Predictor platform. We added 14 new software clients. We realized strong upselling to 24 software clients who expanded their footprint with the ADMET Predictor platform. We partnered with several large pharmaceutical and agrochemical companies to advance machine learning science. And our users do an excellent job of publishing, and in fiscal 2023, published over 55 peer-reviewed journal articles citing ADMET Predictor applications.
Going back to the topic of partnerships, in Cheminformatics, we had several successful ones in 2023. Our team successfully integrated the data that was provided by several large pharmaceutical and agrochemical companies to retrain our machine learning models to predict ionization constants. The increase of our library of experimental pKas to over 70,000 measurements has significantly expanded our chemical coverage space of our industry-leading models and resulted in unprecedented accuracy of the predictions. We also announced partnerships in 2023 with the Institute of Medical Biology of the Polish Academy of Sciences and the Sino-American Cancer Foundation, that are leveraging our expertise in AI machine learning technologies to help with the discovery of novel molecules against two different emerging cancer targets.
The computational and medicinal chemists here at Simulations Plus are working with them to utilize the cutting-edge AIDD technology and ADMET Predictor to accelerate the design and optimization of novel lead molecules. Our primary objectives with these collaborations is to demonstrate the value of our AI machine learning technology, and the capabilities of our drug discovery team in support of our software licensing and consulting service offerings. In addition, both collaborations do provide for incremental benefits of joint compound ownership or milestone payments if successful. Molecules have been selected for synthesis, and we are very excited for the first round of experimental results that should be coming within the next 2-3 months. Turning to future investments, I am especially excited with what we are planning in Cheminformatics, including the expansion of our machine learning models to inform inputs into other software offerings across the Simulations Plus company.
Exploring new AI and machine learning technologies to improve our model performance and to assist with data compilation and curation activities. Developing additional descriptors, both in the two-dimensional and three-dimensional spaces, to extend our chemical coverage space into new territories, which should hopefully allow us to provide expanded solution offerings for different markets and industries. Enhancing our AIDD capabilities and approaches with new functionalities, including retrosynthetic predictions, novelty searches, and more. The Cheminformatics business unit has been very successful, and clients choose to work with us because of our leadership in this space. Our path to win for Cheminformatics is supported by the fact that we are ranked number one for accuracy in published independent comparisons for different ADME endpoints. We have the top-rated machine learning, coupled with top-rated PBPK models that are very tightly integrated in ways that no other company can accomplish.
We have generative AI that is embedded with GastroPlus PBPK simulations to uniquely design and optimize molecules in ways no other organizations can. We have access to premium, carefully curated data, which others do not have, to feed into our machine learning models. There are hundreds and hundreds of peer-reviewed journal articles that are published citing ADMET Predictor to highlight the accuracy of our models with third-party test data. We offer flexible licensing and deployment models that provide options to a wide range of clients across industries. And finally, it's all about the team. We have an expert team of data scientists, developers, and support staff who provide the coaching, maintenance, and training companies need to successfully incorporate AI and machine learning technologies into their discovery programs. Now we turn our attention to the PBPK business unit.
Physiologically based pharmacokinetics, or PBPK, modeling and simulation treats the distribution and elimination of a molecule based on its interactions with tissues and organs. What we're doing here is we're creating virtual animal and human models, and we're trying to simulate how is a drug molecule or a chemical likely to be absorbed into the bloodstream, and how is it then likely to distribute all around the body? PBPK models can be parameterized using a combination of in silico, in vitro, and in vivo data, and their use has exploded within the pharmaceutical, biotech, and generic drug industries over the last few years.
Now, several factors are driving greater adoption, including the increased confidence in the underlying mathematical algorithms and parameter values, more educational opportunities for scientists, and most importantly, guidance from regulatory agencies to incorporate this technology to help reduce R&D costs and accelerate and minimize regulatory burden. In 2022, U.S. Congress also approved the Modernization Act 2.0, that paves the way for companies to use certain alternatives to animal testing, including computer models like the ones we develop in the PBPK business unit, to obtain an exemption from the FDA to investigate the safety and effectiveness of a drug, which further solidifies the positioning of GastroPlus PBPK modeling to really accelerate R&D programs. The application of GastroPlus PBPK modeling spans a wide range, from discovery through post-approval, including first-in-human dose selection, formulation design and optimization.
Drug-drug interaction evaluation, food effect assessments, special population predictions, and virtual bioequivalence trial simulations. GastroPlus, our flagship product, is a comprehensive platform used by over 200 commercial clients, as well as hundreds of academic researchers, universities, and government agencies all around the world. Some of the highlights for GastroPlus in our fiscal 2023 include: we added 21 new software clients in the year. We realized strong upselling to 38 software clients who expanded their GastroPlus footprints internally by adding new licenses and new modules for different departments and divisions. Our services team worked on over 120 consulting projects, about 10 per month. We partnered with the FDA on seven funded grants to advance PBPK science.
Our learning services team trained over 500 scientists during the year on GastroPlus, and our team and users all around the world published over 80 peer-reviewed journal articles citing GastroPlus applications. As mentioned, collaborations is a foundational activity for us at Simulations Plus, and we were successful in advancing PBPK science within the GastroPlus platform in 2023, both through internal investments, but more importantly, funded collaborations with partners. We were one of the very few organizations all around the world to have seven FDA grants in fiscal 2023 to build and validate PBPK modeling approaches for delivery of drug all around the body.
While the funding was helpful, gaining access to data from the FDA and other partners, and reinforcing our relationships and the trust and confidence the agency has in our team and software, is really the reason why we continue to solidify the competitive position of GastroPlus. Now, I would like to discuss some of our regulatory success stories with PBPK. We recently conducted a survey of 30 clients in the pharmaceutical and generic drug industries, and from that survey, we were super pleased to find out that there were 69 self-reported projects from 2020- 2022, where GastroPlus PBPK modeling was successfully utilized to inform regulatory interactions.
The variety of these regulatory applications include dose selection and study designs for IND filings as companies prepare for their phase I trials, waivers of clinical drug-drug interaction studies, waivers of clinical food effect studies, waivers of clinical PK studies in special populations, waivers of major post-approval chemistry, manufacturing, and controls, or CMC changes, and waivers of bioequivalence studies. The key word there is waivers. Lots and lots of waivers of studies. Some concrete examples of approved drugs that have been supported by GastroPlus can be seen here. Novel therapies whose time to market was greatly accelerated through our technology. Now I'd like to just discuss in a little bit more detail a recent success story.
This recent regulatory win in our fourth quarter of fiscal 2023 involved an awesome collaboration between our team of PBPK consulting and regulatory experts, delivering on a physiologically based biopharmaceutics modeling strategy to support a top 50 pharmaceutical company. A mechanistic GastroPlus model was developed and applied to define the dissolution acceptance criteria for the company's commercial formulations of a new drug, and the simulation results were accepted by a global regulatory agency to support the waiver of their originally requested bioequivalence trials. Now, we celebrated with the client, but in our post-project follow-ups with them, we wanted to know a little bit more about how is it that these modeling and simulation approaches with GastroPlus were able to help them realize returns on investment?
They agreed with us that the returns were significant, especially versus the alternatives of doing nothing and losing 10% of their manufactured lots each year, or having to run the risk of that additional clinical bioequivalence study to justify the proposed dissolution specifications. This case study, just realized 6-8 weeks ago, reinforces the turning tide we are seeing with PBPK modeling being treated more and more as an investment and not an expense. There are few things that companies can do, be it experiments or studies, that have the potential to generate returns like PBPK modeling. Now I'll shift our focus here to discuss some of the exciting future developments and cross-selling opportunities for the PBPK business unit. It's hard to believe that we are celebrating the 25-year anniversary of the release of GastroPlus 1.0 in 2023.
For 25 years, we have emphasized science and have worked with many, many clients and partners to develop a PBPK modeling platform that met their research requirements from discovery, going all the way through to development. Now, to recognize this milestone in the GastroPlus life cycle and prepare for the next 25 years, we are moving forward with the release of the next generation GastroPlus environment that's branded as GPX in 2024. To get to this achievement, we have been thoughtful and deliberate about the design, the workflows, and the integration aspects to ensure it meets the needs of today's PBPK modelers and those that we welcome to the GastroPlus user community in the years ahead. The four areas of primary investment for this GPX environment include: model customization, software engineering, data management, and deployment options.
In addition to GPX, we are making investments in PBPK in the following areas, including integrating QSP and CPP technologies within the GastroPlus environment to expand product and service offerings. Applying AI to provide expert PBPK coaching and support to users on a real-time basis to expand our client base. Building mechanistic delivery models all around the body for different molecule types to support new formulation technologies for small molecules, peptides, and biologics. Providing true polypharmacy simulation capabilities to mimic a patient's real-world medication schedule and better assess things like drug-drug interactions, fixed-dose combination products, and more. There are numerous reasons why our PBPK team has been so successful and why companies engage us.
Our PBPK business unit has five key drivers on our path to win, including being ranked again number one for accuracy in all published independent comparisons of PBPK software, which really highlights our laser focus on science and innovation for 25 years. Having over 1,000 peer-reviewed journal articles that have been published citing GastroPlus, which highlights the validation and the qualification of the platform for all applications during drug development. Receiving over 20 funded grant partnership awards from the FDA since 2015. Over 20. This reflects the significant trust and confidence the FDA and regulators all around the world have in the GastroPlus platform and our team of experts. Having that team of experts, of modelers, of developers, and support staff to provide the coaching, the maintenance, and the training companies need to successfully incorporate PBPK modeling into their R&D programs.
Finally, offering flexible licensing models that provide access to a wide range of clients across industries, including chemicals, cosmetics, consumer goods, and CRO markets that are in addition to the pharmaceutical, biotech, and generic drug spaces. With that, it's my pleasure to turn the meeting over to Jill Fiedler-Kelly and Jonathan Chauvin to discuss our Clinical Pharmacology and Pharmacometrics business unit. Take it away, Jill.
Thanks so much, John. That was really great. Hello, everyone. I am Jill Fiedler-Kelly, and along with Jonathan Chauvin, we will be providing an overview today of our clinical pharmacology and pharmacometrics business unit. I appreciate that's a bit of a mouthful, so internally and hereafter in today's presentation, we will refer to our group as CPP. First, I'll share a little bit about my background. I co-founded Cognigen in 1992 and have been with Simulations Plus since it acquired Cognigen in 2014. I now have over 30 years of modeling and simulation experience, assisting companies with the strategic design and implementation of pharmacometric modeling and simulation approaches in new drug development programs.
In addition to publishing many scientific papers and co-authoring a textbook on population PK/PD modeling, I am also an adjunct professor of pharmaceutical sciences at the University at Buffalo, otherwise known as SUNY Buffalo, where I teach workshops and assist with a graduate course in population PK/PD modeling. Now, when our Cognigen team was contemplating becoming part of the Simulations Plus organization, we immediately identified with and shared the client-centric focus of the team. We truly appreciated the hard-earned reputation for high-quality science that was evident in both the first-in-class software tools and in the consulting staff. We hope to develop synergies between our teams and share our experiences to establish even better practices in support of our clients.
I have elected to stay here because they understand not only the science, but the importance and the impact of our work, and they recognize that the true value of our company is our people, and that keeping our team whole is essential to accomplishing our goals. Importantly, they're also committed to growth and innovation, which paints an even bigger and richer picture of possible opportunities for how we together serve our clients and help patients get the treatments they need. As we have more fully and completely integrated our teams over the years and continue to deliver on our shared vision and mission, we have embraced and nurtured a culture of collaboration and respect, and never faltered in upholding our reputation for excellence. Now I'll turn it over to Jonathan to highlight his background and experience within Simulations Plus. Jonathan?
Thanks, Jill. I joined Lixoft in 2015, and I've been with Simulations Plus since its acquisition of Lixoft in 2020. Prior to joining Lixoft, I worked as a research engineer, project manager, and product manager at IFP Energies nouvelles in France. During this period, I filed more than 30 patents and directed 20 publication and referred committees, newspaper articles, and 50 conference papers in these areas. I've been here for the last past 3 years because Simulations Plus share the same values and belief. We are at Lixoft because Simulations Plus help us with to continue the growth of the product we have been building for years by giving a lot of autonomy and a lot of support. In addition to Jill and myself, we have an extremely strong team. The CPP business consists of the MonolixSuite software solutions.
These solutions are supported by our highly skilled service system that partner with our clients to help them solve their unique development issue using our software on premise. We'll discuss services more in just a few minutes. MonolixSuite is the most user-friendly, state-of-the-art software tool for pharmacometrics modeling and simulation available. We have a team of highly experienced developer committed to continuously improving our software, offering based on cutting-edge research, and incorporating feedback from our clients and internal consultants to ensure the relevance and its future and functionality, as well as its ease of use in the streamline modeling workflow. I would like to turn it back to Jill to provide some metrics.
Thanks, Jonathan. The Clinical Pharmacology and Pharmacometrics business unit achieved approximately $19 million in revenue in fiscal 2023, with 62% from services and 38% from software sales. For the fiscal year, the MonolixSuite represented 19% of our total software revenue. We added 12 new consulting clients during fiscal 2023, and our services team grew with the addition of 5 new consultants. We're excited that the number of companies using MonolixSuite exceeded 100 in fiscal 2023, and we achieved over 95% client renewal rate based on fees for MonolixSuite. For the first time in fiscal 2023, the CPP service and software teams worked together on a funded project from the U.S. Food and Drug Administration, supporting the development of best practices in novel bioequivalent studies for long-acting injectable products.
This research effort was centered around a complete framework for model-integrated design using Monolix Suite. I'll now discuss our CPP services offerings. CPP business unit's vision involves advancing the science and engineering the systems for model-informed drug development. We accomplish both aspects of this vision through the integration of our software and our services offerings. As we help clients address the critical development and regulatory challenges they face by providing the highest quality modeling and simulation support using Monolix Suite, we are also improving the efficiency of their development programs. As such, we are continuously focused on improving our products and the processes we use to deliver quantitative support. Addressing clinical pharmacology and pharmacometrics objectives involves understanding the determinants of safety and efficacy of new medicines.
The models we develop help our clients to have greater confidence at decision-making milestones, to improve the chances for success with innovative therapies, and ultimately, to enhance the value of these new medicines for both patients and providers. Using available clinical data, we develop pharmacokinetic models. These models represent the movement of drugs through the body. Pharmacodynamic models, which describe the positive or negative effects a drug has on a patient, and exposure response models, which elucidate the relationships between dose, individual patient drug exposure, and outcomes. By exploring and quantifying the influence of patient factors on these processes, our models are used to select the right dose to give to the right patients at the right time in order to achieve optimal outcome from therapy.
Now, whether we're working with a small startup company lacking internal resources, or a top fifty pharma partner requiring specific expertise from our team, the solutions we offer provide our clients confidence with both development and regulatory decision-making milestones and help to improve the efficiency of their programs. Our team of highly experienced quantitative experts support all aspects of model-informed drug development, providing strategic input and guidance for clinical pharmacology development and regulatory submission of modeling work, in addition to the model development and applications to address key questions and support decision-making. Importantly, CPP consultants using MonolixSuite to deliver quantitative support to clients, provide critical feedback to the developers, resulting in natural synergies between the teams, and ultimately strengthening both the product and the service team's efforts, ensuring that development efforts are focused on high-impact features that help users. Jonathan will now talk about MonolixSuite in greater detail.
Thanks, Jill. At CPP, our product is the MonolixSuite, and is designed to save the time and energy of pharmacometricians and biostatisticians. It brings a breakthrough advances to the modeling and simulation community in user-friendly tools modules. First, PKanalix for non-compartmental and compartmental analysis, Monolix for nonlinear mixed effect modeling and parameter estimation, and Simulx for model-based simulation. Our products are also designed to break the preclinical-clinical divide for modeling and simulation, and allow all stages of drug development to share information and synthesize them in common studies. MonolixSuite was intentionally designed to provide seamless and efficient workflow across analysis steps.
While other tools or combination of tools require multiple data processing steps to format the data for each different analysis, MonolixSuite supports the use of a single dataset and offers the analyst the ease of working within the user-friendly graphical interface for modeling the flexibility to write custom scripts. Comprehensive documentation and examples are freely available, which can be used as templates for new projects to further reduce the learning curve for the new user. Here are just some stories of the success we have had here in our CPP business. During the last year, our pharmacometric consultant performed PK/PD modeling in support of a highly anticipated novel therapy being investigating to treat a rare disease affecting children. Our team of experts subsequently assisted the sponsor with preparation under the advisory committee meeting, resulting in the successful attainment of accelerated approval granted by the FDA.
A team of modeling experts from the CPP business unit are using MonolixSuite to develop a PK/PD platform model framework that will enable our client to quantitatively support go/no-go decision-making for oncology compounds based on linking early biomarker data to predict late clinical endpoint. We also provided modeling support to a client applying AI to precision-engineered medicines. The model findings are being used to make critical decisions to enable model development-related decision-making for pipeline candidates. Our services team provided pharmacometrics and exposure-response modeling support for a compound offering novel treatment for a rare genetic disease affecting children and adults, following approval by FDA. The modeling work was used to support labeling statements that described dosing recommendations for the compound.
The incorporation of AI and machine learning methods in pharmacometric analysis and associated data processing activities may allow for further increases in efficiency and streamlining of workflows to expedite generation of results. Current projects are affording the opportunity for collaborations between QSP and CPP scientists, leveraging mechanistic QSP models developed to support early decision-making, to expedite the analysis of clinical data from first-in-human studies, and similarly, leveraging empirical PK/PD models by adding complexity with the characterization of additional endpoints and pathways incorporated into a QSP framework. MonolixSuite has firmly established itself as the gold standard within the scientific and industrial community. Ongoing investments in research and development are focused on several key areas. First, efforts are being made to expand the suite's functionalities, ensuring it remains at the forefront of cutting-edge research.
Additionally, there's a commitment to enhancing integration to the global environment of our users, such as laboratory information management systems or LIMS, other software used by the community, and et cetera, to increase the integration build. The development team is also dedicated to refining the suite's workflow, aiming to create a more user-friendly and intuitive experience for both researchers and educators. Finally, emphasis is placed on improving interoperability across various applications domain, fostering a versatile and adaptable toolset for different types of user. Now, Jill will discuss with our teams to win. Jill?
Thanks, Jonathan. I'll wrap things up by sharing why the CPP team continues to be successful. CPP's path to win consists of four points: our unparalleled offering, our supportive relationship-based model, the solid and comprehensive infrastructure that supports both our software and consulting solutions, and importantly, MonolixSuite's reputation for ease of use. The first is our unparalleled offering. The combination of our staff's extensive experience and expertise in supporting model-informed drug development programs in a plethora of therapeutic areas, together with our use of the best-in-class software tools to provide modeling and simulation support, is an incredibly valuable resource to our clients. We believe that the relationships we build with our clients are equally as important as the work we do and the questions we answer. We always communicate with transparency and integrity.
Our clients know with certainty that our team is committed to providing the best support we can and being there with them until the job is done. The excellent support we provide extends to our software clients as well, with accessible expert application managers ready to answer client queries and provide guidance for better integration, along with an extensive library of models and documentation available to support new and existing users. Our infrastructure and quality management system successfully withstand numerous client audits and provide the ideal platform to support the delivery of reproducible modeling and simulation results intended for regulatory submission. MonolixSuite has garnered a reputation for being exceptionally user-friendly, offering a simplified and intuitive interface that facilitates ease of use across different skill levels. Its prowess shines when it comes to solving complex problems swiftly and efficiently.
It boasts a comprehensive workflow that covers the entire spectrum of pharmacometric research, from non-compartmental analysis to population modeling and simulation, making it a versatile and all-encompassing tool for researchers. The suite is further bolstered by its robust documentation and dedicated support team, ensuring users have the resources and assistance they need for a seamless experience. Notably, MonolixSuite is committed to continuous improvement, regularly enhancing its capabilities to stay at the forefront of scientific advancements and user needs. Thanks to everyone for joining us today. We hope this has given you greater insight into our CPP business. With that, I'll turn it over to Brett Howell to discuss QSP. Brett?
Thank you, Jill. Hello, everyone. I'm Brett Howell, president of our Quantitative Systems Pharmacology Solutions, or QSP, business unit. I've led the QSP team for the past 6 years, ever since Simulations Plus acquired our DILIsym Services group in 2017, for which I served as the Chief Executive Officer at the time. I've dedicated much of my professional life to the mathematical studies of disease treatment and drug-induced liver injury. I've served as the Associate Director of the DILIsym Initiative Consortium since it started in 2011, and have published over 30 scientific papers in the area of PK, PBPK, PK, PD and QSP modeling, in vitro toxicity testing, novel drug delivery systems testing, and drug safety.
QSP is an exciting and rapidly growing field of biomedical research that aims to model the mechanisms behind disease progression and quantify the pharmacokinetics, or the movement of drugs through the body, and the pharmacodynamics of pharmaceuticals using mathematical computer models. It is a critical component of drug development more and more every day. Simulations Plus has leveraged the legacy DILIsym Services expertise in fibrosis and inflammation. In 2017, when QSP became part of the offerings, we had a team of only eight consultants. We've now expanded into new therapeutic areas with the recent addition of the Immunetrics team. Today, we have a team of over 30 QSP consultants, most of whom have PhDs in mathematics or different areas of life science.
Our QSP team at SLP combines a knowledge of mathematics, disease pathophysiology, which is the study of how a disease or injury or other condition impacts an actual patient, and pharmacology to help our clients in the pharmaceutical and biotech spaces make better decisions about dose, trial design, patient selection, target selection, and much more. Now, thinking of our library of offerings, our acquisition of Immunetrics really strengthened our already robust QSP offering set here at SLP. With Immunetrics, our QSP team is now a $10 million-plus annual revenue group, as we are now able to provide support for an even greater range of therapeutic areas in a field with tremendous growth opportunities. The SLP QSP team now has the broadest range of therapeutic area coverage of any QSP team in the industry, stretching from fibrosis to inflammation, to autoimmune disease, to oncology, to safety, and beyond.
Our bandwidth is key. The SLP QSP team has one of the largest QSP groups of modelers in the world, providing unparalleled bandwidth for our clients to extend beyond their internal employee bandwidth. Our leadership team has more than 100 years of combined experience in the growing and maturing field of QSP modeling and simulation within the therapeutic development space. Now, on the services side, the QSP team has platforms available across the therapeutic development landscape, including a myriad of diseases. Our coverage of diseases in fast-growing areas such as oncology, make us poised to increase our engagements over the coming years. Our unique combined emphasis on the mechanistic understanding of both efficacy, or how a drug works, and safety, or the negative impacts of a drug, allows us to optimize this balance between benefit and risk.
In all of the therapeutic areas shown, we offer milestone-based consulting project structures of a large nature to help with trial design, dose selection, target interrogation, and more. We also offer time and materials or hourly engagements to help guide the appropriate use of simulation results within a program as it relates to future use and regulatory application. On the software side, we have a litany of technologies. Our QSP platform technologies enable our therapeutic area models, and they include proprietary infrastructure built within these different environments. For instance, we have Thales, which drives our oncology and autoimmune models. We have MATLAB, which drives many of our newest models and models that are in development for clients currently. We have Julia, which drives our NAFLD/NASH platform. And finally, we have C++, which drives our safety platforms.
The key is that all of our platforms are available for licensing to our clients, enabling our clients with QSP teams within their own shops to partner with us in a very collaborative way. Many of our engagements involve actually customizing these software platforms and then licensing them to the clients, leading to an initial services revenue, followed by a higher margin software revenue as we go forward. Now, let's turn our attention to some success stories.
First, one success story that's not shown here on the slide, we have a case where the results of an efficacy or effectiveness-focused simulation project, the results were submitted by a blinded client to the FDA that resulted in the removal of one of the requested dose levels within the phase III study, which saved the company $ many millions on that particular trial arm that they did not have to run. Next, we'll talk about Biohaven. The company had the CGRP program, a set of compounds focused on treating migraine headaches, where they were predicted to be safe by the DILIsym liver safety platform, despite historical clinical liver toxicity from other drug candidates that were in the same space, focused on the same target. The company moved forward with confidence. They showed safety in their trials.
They received FDA approval and subsequently sold that CGRP program to Pfizer for $11 billion. Next, we'll talk about Cenicriviroc, which is a therapeutic candidate for NASH or liver disease, which was taken into a very, very expensive phase III study, where it failed to show efficacy. Our NAFLDsym model of NASH in the liver showed simulation results that were presented at The Liver Meeting, public scientific meeting, where that QSP tool could clearly predict the mechanism of action, in this case, would not be effective. So there are many, many similar projects like this behind the scenes, where we have conducted projects with sponsors to help them better understand which approaches are going to work for a particular disease and which approaches are not. Lastly, there's an exciting recent example around the compound fezolinetant.
This was a recently FDA-approved drug, which promises to be a billion-dollar seller for the company Astellas. It was progressed to approval after our liver safety platform, DILIsym, helped successfully pick the phase III dose range of 30-45 mgs, which was cited in the FDA's medical review of the drug, leading to the drug's approval despite liver issues at much higher doses. Now, as we kind of turn our attention to the future, we have several exciting QSP initiatives on the horizon, which I believe are really gonna take us strong into the future. First, we have a big emphasis on expansion into more and more indications within oncology and cancer. Next, we have therapeutic area expansion in other arenas. We already have work underway in the complement cascade area, which touches many, many conditions, as well as in neurology.
Lastly, I think the combination of AI and QSP modeling, both in terms of model development and in terms of application, will be leveraged more and more and more with our in-house capabilities and exploration already underway on this endeavor. Now, to wrap it up, why do we win in the QSP space at Simulations Plus? The QSP path to win is driven by these four key areas. First, we're focused on diseases of relevance to our clients and the flow of capital within the industry. Second, we are industry experts. The QSP group is composed of a very large team of knowledgeable experts, making the offering both scalable and adaptable to large, medium, and small companies. Next, the combination of software and services is very important.
The combination of these two allows us to tailor our solutions for large, medium, and small companies, something that other small shops are not necessarily able to do. Lastly, the SLP ecosystem is very important. The combination of our QSP capabilities focused on disease, with our exposure modeling tools focused in the PBPK and pharmacometrics arenas, such as GastroPlus and Monolix, really, give us an unparalleled, sort of synergy in the industry. To wrap it up, QSP has become a critical component of drug development, and our team here at Simulations Plus is really leading the industry in terms of the depth and breadth of QSP capabilities. We offer clients QSP modeling and service solutions for over 20 therapeutic areas, including various indications within oncology, different fibrotic disorders, and multiple autoimmune disorders.
Now I'm gonna turn it over to John DiBella to discuss the last phase in the drug development process, regulatory approval. John?
Thank you very much, Brett. Hello, hello again, everybody. Our Regulatory Strategies offering was officially launched three years ago, and we have realized great success since it started. The team works side by side with clients to navigate the complex global regulatory arena with clear strategic objectives and planning. The ultimate objective is to ensure patient-centric drug development processes, including incorporating modeling and simulation as needed, to reduce the number of information requests from health authorities to accelerate drug product approvals. Our leaders for this offering are Dr. Sandra Suarez-Sharp, Chief Science Officer, who's been with the company for three years and was previously with the U.S. FDA for over 20, serving in a variety of roles across several different offices and divisions.
And Dr. Xavier Pepin, Associate Vice President, who has been with the company for about 18 months, and prior to that, spent 15 years leading global biopharmaceutics teams at AstraZeneca and Sanofi, where he successfully applied modeling and simulation approaches on several approved drug products, helping reduce costs and accelerating the time to market for those large pharmaceutical firms. The Regulatory Strategies team provided support on nearly 30 client projects in fiscal 2023. Examples of successful applications include the de-risking of the analysis of a PBPK application in support of widening the dissolution acceptance criteria for a combination drug product that was based on control strategy and published exposure response analysis information.
Another one was analyzing and evaluating the biopharmaceutics and clinical safety profile information that was generated by a sponsor company to carve out a feasible path for the approval of a real-time release testing dissolution model that focused on the creation of a safe space to support risk assessment. Most of our projects in the regulatory strategy space have been focused on the holistic understanding of regulatory applications of PBPK modeling to support clinical drug product development. Based on the successes that we've realized to date, we have identified opportunities to expand this service offering through the strategic hiring of personnel. Personnel with deep knowledge of regulatory requirements at different stages of drug development, including, but not limited to, preclinical pharmacology and toxicology, clinical pharmacology, Chemistry, Manufacturing, and Controls, and generics.
Strategically, also hiring regulatory experts with experience using different modeling and simulation approaches, like PK/PD, and exposure response, and QSP. Also strategically recruiting and hiring regulatory experts in key geographical markets, including Europe, Latin America, and Asia. I'm now happy to turn the meeting over to Mr. Josh Fowler, who will help connect the dots for us from our offerings to our sales and client approach. Take it away, Josh.
Thank you, John. Welcome, everyone, and thank you for your interest in Simulations Plus. Now that you have heard from our various business units and have a better idea of our offerings and future outlook, I will now tie everything together from a sales perspective. We are a cutting-edge modeling and simulation company, specializing in serving pharmaceutical companies at every stage, from early discovery to post-approval. Our expertise lies in harnessing machine learning and chemistry, as well as employing advanced methodologies such as PBPK, QSP, QST, pharmacometrics, and regulatory support. By leveraging these tools, we empower pharmaceutical companies to make informed decisions, optimize drug development processes, and navigate regulatory challenges effectively. Our mission is to accelerate the delivery of safe and efficacious medicines to patients worldwide, revolutionizing the pharmaceutical landscape through the integration of industry-leading technologies and scientific expertise.
Hopefully, everyone has a better understanding of Simulations Plus, but I am sure there are some questions about what we are going to do moving forward. We have defined a set of new business development strategies that allow us to be successful. Alliance management continues to be crucial to our success. Bringing together strategic partnerships that drive past one-off services or deployment of software to a place where we are better understanding the challenges of our clients, is our mission. We help them win by connecting them right to the regulatory guidances. We cater training, we have consultants as an extension of their team, and we have opportunities to evolve the science in our software programs to the fullest extent possible, hand in hand with us.
Bundling our software solutions to maximize the value proposition of our partnerships is what separates ourselves in the client landscape and is a proven strategy. We have put together first-in-class bundling offers that provide more value than our competition, either as a combination of services or cater to the phase of development, like our first-in-human packages. Lastly, more therapeutic alignment with our partners to cater offerings that help them better understand how to prioritize experimental work and design the optimal approaches is a major focus of us. I just highlighted our overall growth strategies, but what about the growth for each business unit? First, we are seeing lots of opportunities in our CPP offerings. The ability to offer consult and coach to help clients provide more value than just a service, and demonstrate the usability of MonolixSuite as a superior software solution compared to traditional approaches.
We are also seeing success when going head-to-head with competitors, with price differentials when using the MonolixSuite for consulting services. Next, we believe our PBPK offerings are more comprehensive and flexible than our competitors, and we welcome the opportunity to demonstrate our product versus the competitors to prove this. Numerous industry publications continue to state that GastroPlus is the regulatory standard. And the inputs from our machine learning separate us from competition and are getting even more accurate. These are very, very strong selling points. We are also very excited about cheminformatics. ADMET Predictor plays a critical role in drug discovery to accelerate the assessment of chemical compounds, and hand off informed strategies to pharmaceutical development programs. We further support candidate selection with the new offerings, such as HTPK and AIDD, to connect discovery and development teams of our partners.
The launch of Discovery Services Group allows you to help partners that don't have the internal capabilities, and offers flexibility to open doors to those partners of all types of companies. Another opportunity is with Regulatory Strategies . We offer a review of our partner program with catered modeling and simulation plan to save experimental work, to prioritize decision making, and to respond to regulatory questioning. We offer clients peace of mind, along with expert consulting from ex-FDA and large pharma thought leaders. We show monumental wins in their program, all while championing for the adoption of our software solutions as a hub of those partnerships. Finally, we see QSP expansion in a multitude of key therapeutic areas, accelerating the integrated selling of our accounts. QSP is becoming standard, like where we were with PBPK five years ago.
We offer clients critical uptake and understanding of their therapeutic and disease areas, and support them in optimizing their trial designs. Finally, I would like to discuss how our new organizational structure will benefit our sales strategy by better aligning our different units to meet the clients' needs. In fiscal 2023, we sold to over 400 accounts, and of those 400 accounts, approximately 15% of them had a solution that was sold across two business units. While this demonstrates the leverage in our acquisition strategy to provide clients with multiple solutions from a single company, we see significant opportunity to further connect our ecosystem of software and solutions in those accounts where we have relationships in already. To better serve our clients, this new structure is now strategically connected to the outcomes of each phase of development and modeling solutions that continue to connect those stages.
I would like to highlight some accomplishments of our team over the last fiscal year. We have greatly increased our bookings from large pharma partners. We sold to over 400 accounts. We increased our client engagement and alliance management, also known as our Concierge Program . Overall, over 90% of our bookings were for pharmaceutical companies. Over 80% of the software bookings were renewals and upsells, with price increases passed along. We've increased the number of optional tasks in our services projects to better support those partners and move those partners in a strategic manner. The entire team is excited about the future and believes our organizational structure will enhance our sales efforts and better serve our clients. I would like to now turn it over to Shawn and Steve to discuss M&A and the Immunetrics integration. Shawn?
Thank you, Josh. Now that we've covered all of our existing businesses, let's talk about the other part of our strategy, M&A. We'll then provide you with an update on our integration of Immunetrics, our most recent acquisition that we announced last quarter. To start, we view our M&A strategy as a supplement to our organic growth. We see M&A as a means to strengthen and expand our market position, drive growth, and enhance shareholder returns. Selecting the right acquisition target is our first and foremost consideration, and we base the selection on criteria that align with our strategic goals. For those that have followed us for a while, you know that we are highly selective and committed to responsible growth. M&A that we consider must meet the following criteria: target business expands our TAM or accelerates capture of market share in existing TAM.
Target technology services are compatible with existing capabilities. Target culture is compatible with our culture. Target valuation is reasonable, and target is agreeable. The target population of our M&A strategy is driven by three objectives: provide clients with more product and service solutions, including AI capabilities, expand our total addressable market, or TAM, and develop and enhance our talent resources. The opportunities currently in our pipeline fit within these three categories and are mostly sized consistent with historical acquisitions of approximately $5 million-$10 million in revenue, some larger targets as well. It's important that we look for businesses that help create long-term value. That's what we found in Immunetrics, an ideal target that expands our market in the vastly growing area of QSP, and marks the beginning of a transformative offering for our clients.
Immunetrics has increased the range of therapeutic areas addressed by our QSP software and service offerings by more than 50%, and introduced new areas of service to clients. It's an ideal fit as the business leverages our existing infrastructure by expanding its therapeutic resources into largely underserved areas, including immunology and oncology. I first met Steve over two years ago, and we maintained communication as we looked for ways for our companies to combine forces during this time. Our view of the QSP market was consistent, and areas of therapeutic focus complementary, but early financial performance evaluation discussions did not result in a transaction. Steve, I'll turn it to you to discuss the integration so far.
Thank you, Shawn. I am Steve Cheng, President of Immunetrics. As Shawn mentioned, we share similar viewpoints on the QSP market and areas of focus. When I met Shawn, we had been developing Immunetrics' portfolio of therapeutic models and working towards developing QSP standards through a platform we call Thales, which is an integrated platform for standardized model development, spanning model design to simulation to analysis. Thales addresses a growing need for both pharma and regulatory agencies, but frankly, to be effective, we needed a much larger partner with credibility to expand our client base for therapeutic models and accelerate the standardization in both pharma and regulatory communities. Immunetrics has been in the industry for 23 years, and we have developed a number of industry contacts, especially at large pharma.
While asking around for a strategic partner, it became obvious that Simulations Plus was well respected and liked by the community, and it seemed like a terrific choice.
Once , Immunetrics was able to establish a significant sales pipeline for its therapeutic areas of focus. We were able to consummate a mutually beneficial deal.
That's right, and post-acquisition, things have been going great. While there is certainly a lot of change to adjust from being a small business to a publicly traded one, the business development infrastructure within Josh's group have provided a broad base of existing clients that are now leading to new opportunities and business for QSP.
As we demonstrate our capabilities to this broader base, I see very strong revenue growth potential. We're pleased to welcome the Immunetrics team into the Simulations Plus family. Thank you for your time, and now I'd like to turn it over to Will Frederick to discuss our financials and ESG.
Thank you, Shawn. Having reported our fourth quarter and fiscal 2023 earnings results a few weeks ago, I will provide a quick overview of our financial results and then move on to a couple of other topics. For fiscal 2023, we delivered strong revenue and earnings results, especially as market conditions remained similar to what we've discussed over the past several quarters. As we said in our recent earnings call, we saw a slowdown from small biotech clients, and purchasing from large pharma companies also remained delayed, primarily driven by macroeconomic uncertainties and conservativeness.
We anticipated these challenges last year when we provided our fiscal 2023 guidance for revenues to grow 10%-15%, and we met that guidance, delivering 11% revenue growth for fiscal 2023, as we were able to offset these challenges with our ability to upsell and execute on price increases throughout the course of the year. For the fiscal year, net income was $10 million or $0.49 per diluted share, and adjusted net income for the fiscal year was $13.8 million or $0.67 per diluted share. This was at the high end of our $0.63-$0.67 fiscal 2023 guidance that we provided in 2022. As Shawn mentioned, we are excited to welcome Immunetrics into the organization this past quarter and are very happy with how the integration is going.
Immunetrics has a healthy pipeline of activity, including new accounts sourced from our client base, helping to increase our overall services backlog to $20 million, compared to $16 million last year. Anticipated revenue from our backlog within 12 months remains around 70%-80% and is based upon the nature of the backlog as we enter the fiscal year. We also saw the benefit from the increased mix of time and materials projects compared to fixed-price projects, with the former typically having higher margins and thereby contributing to the growth of the services margin to the mid-60% range. Against the current market backdrop, our revenues and earnings were in line with our expectations. For the year, total revenues were $59.6 million, up 11%, driven by software growth of 12% and services growth of 8%.
Software revenue represented 61% of total revenue, and for the year, GastroPlus represented 54%, MonolixSuite and ADMET Predictor were each 19%, and other software was 8% of software revenue. For services, PK/PD represented 45%, QSP/QST was 25%, PBPK was 23%, and 7% was from other services, primarily from regulatory work performed. For the fiscal year, our client renewal rate declined to 92% based on fees and to 82% based on accounts. But we were happy to see that average revenue per client for the fiscal year increased to $126,000, up from $110,000 last fiscal year.
As discussed during the fiscal year, renewal rates were affected by the slowdown from small biotech clients who have been impacted by funding scarcity, as well as delayed purchasing from large pharma companies driven by macroeconomic uncertainties and conservativeness. During the fourth quarter, we had a few one-time expenses that we discussed on our earnings call and in our reporting of adjusted earnings. These included $1 million in M&A costs, a $1.6 million compensation expense for Immunetrics related to its acquisition, and an impairment charge of $25 million for discontinuing the Cognigen name. Excluding these costs, our fiscal year adjusted EBITDA was $20.6 million, and adjusted EBITDA margin was 35%. We continue to report solid gross margins for the fiscal year, with total gross margin at 80%, software gross margin at 90%, and services gross margin at 65%.
With the addition of Immunetrics and their higher services to software mix, our total gross margin may be impacted for fiscal 2024 compared to fiscal 2023. Now, turning to our capital allocation strategy. We continue to make internal investments in both R&D and employee recruiting and retention. In fiscal 2023, we had 46 new hires, including 20 from Immunetrics. We've also consistently paid out a quarterly dividend to shareholders for the last 10 years. We completed our acquisition of Immunetrics in June 2023, and we ended the fiscal year with $115.5 million in cash and short-term investments. We remain well-capitalized, have strong free cash flow, and seek opportunities for strategic acquisitions, investments, and partnerships. As Shawn mentioned on our earnings call, we set guidance based on a status quo market outlook.
For fiscal 2024, we expect revenues to increase in the range of 10%-15%, or $66 million-$69 million. From a mix perspective, we expect software to contribute 55%-60% of revenues and services to contribute 40%-45%, reflecting the increased services to software revenue mix from the Immunetrics acquisition. Further, we are guiding to diluted earnings per share in the range of $0.66-$0.68, or an annual increase of 35%-39%. We expect our effective tax rate for fiscal 2024 to increase to a range of 20%-22%, compared to the fiscal 2023 rate of 15% that reflected a tax benefit in the fourth quarter of fiscal 2023. Of note, our fiscal 2024 EPS guidance of $0.66-$0.68 reflects the higher estimated effective tax rate.
If we were to realize the same effective tax rate as fiscal 2023, our guidance would be in the range of $0.72-$0.75. To recap, we are pleased with the double-digit revenue growth we delivered in fiscal 2023 while navigating a challenging backdrop. We successfully implemented our contract harmonization program, which has led to greater alignment with our clients. We grew software double digits and saw strong performance from our services business, with that team finishing the year with a 25% increase in our backlog. Finally, as Josh outlined, we implemented a new organizational structure to better align our five solution scientific domains to further improve our clients' buying experience and meet our commitment to deliver greater value to them. Now to our environmental, social, and governance, or ESG, activities. Today, I'd like to discuss how our commitment to ESG supports our core business objectives.
Since 1996, our core mission has been to accelerate the development and delivery of better, safer, and more effective therapeutics. The potential our mission offers for improving patients' lives and advancing and improving global health has broad and indisputable positive impacts for society and is evidence, we believe, of our company's long-term financial sustainability. When I arrived in fiscal 2021, we outlined a strategy to expand our focus and emphasis on ESG. Over the past three years, we've worked to identify areas where we can more fully integrate practices that align with our mission and values and the four pillars of sustainability: environmental, social, governance, and human capital. Our environmental focus: to minimize the environmental impacts of our operations, directly or indirectly, by waste reduction, recycling practices, and by using renewable energy providers where possible.
Our social focus: to advance science and innovation through partnerships and collaboration to benefit global health while minimizing the negative social impacts of traditional research. Our governance focus: to ensure comprehensive oversight of enterprise and ESG risks associated with our business, leveraging policies and procedures, training and awareness, and internal control. For our human capital focus, we embrace a culture of engagement, empowerment, diversity, equity, and inclusion, or DEI, to attract, engage, and retain a talented and diverse workforce dedicated to promoting scientific innovations. As we continue to integrate the operations of our five business units, we are working toward developing a comprehensive cross-functional quality management system, or QMS.
With policies, procedures, and controls that are consistent across the company. QMS is comprised of policies, standard operating procedures, and general procedural guidelines, including the roles and responsibilities for each functional area. It provides uniform, permanent records of operational methods, development techniques, and other tasks relating to our business processes and procedures, thereby creating operational standardization and consistency. We believe our QMS also serves as an important foundation for employee training and for our continued focus on serving our clients and meeting their audit requirements. As a technology company, we recognize that innovation is vitally important to achieving our objectives. We are continuously improving our products and services, and collaborations and partnerships with the pharmaceutical industry, universities, and government agencies. These successful endeavors have resulted in some of our most advanced product features. As you can see, commitment to ESG is very important to our culture.
We believe this commitment is driving continual improvement in our business. Thank you for your time today. With that, I'll turn the call back to the operator to open the floor to questions for all of our presenters today.
Well, thank you, everyone. We are now ready for our Q&A section of today's event. Our first question, Shawn, comes from Francois Brisebois. He's asking, "Can you compare your growth versus the growth of the market?
Hey, Frank. Thanks. Yeah, growth, as we, you know, sort of cited, mid-15% growth CAGR for the Biosimulation market, projected out over the coming years. This certainly has been a year in which the Biosimulation market, I think most vendors, suppliers to the drug development world have seen a little slower paced growth. Macroeconomic issues across the board, biotech funding challenges, means that in that environment where the average growth mid-teens, 16%, this is a year that's probably below that across the industry. There'll be years that are above that.
Our growth this year at 11% for this past year, was good performance in, in that environment, and, you know, I think was at, about where the market would have been overall, if the, if that 16% growth, number was calculated for this year specifically. Have seen some improvements, some positive signs. I think we used the word cautiously optimistic, as we looked out, into, our fiscal year 2024 and set our guidance. Some good indicators in terms of spending, activity out there that, hopefully will, turn to, a higher spending, actual spending as we get into the 2024. Our goal has always been to grow, grow at or above the overall, growth rate in, biosimulation.
I think if you look back over the years, our growth over the last five, six, seven years has been of that nature. We've ranged from the 11% that we grew this past year. We've grown over 20%, 22%, 23%, I think, in the past, and typically have been in the mid-teens. So you know, our goal is to grow at or above biosimulation overall. I think that growth rate of mid-teens, 16%, is a good peg in the ground for biosimulation growth industry-wide over time. And we'd look to beat that on an annual basis.
Okay. Frank has a follow-up question. "Can you describe the history of your relationship with regulatory authorities? And when the agencies validated and started using the simulations, barrier to entry for competition.
Yeah, I mean, our relationships with the regulatory bodies have been very strong over the years, right from the beginning. Why don't I hand this off to John, longest tenured member of the team, can walk us through the relationships with the regulatory agencies and the importance thereof.
Yeah, thanks a lot, Shawn and, Frank, really good question. Thanks for asking. I think it's been over 20 years ago, when we first started to receive invitations from the FDA and some of the other regulatory agencies, to come by and visit and talk a little bit more about what it was we were doing to simulate mechanistically the absorption of drug and how it distributed throughout the body and in virtual animal or human systems. And following on those first invitations, we then did some follow-up trainings and really started to help educate the regulators on some of the latest, greatest science in these areas.
I would say a few years after that, as we were getting into the late 2000s, early 2010s, that's when you started to see more publications, conference presentations being delivered, that were coming out into the public domain, that were highlighting a lot of the research that the agency, specifically the FDA, was doing their own internal efforts to learn and validate, the approaches, specifically PBPK modeling, and then start to share best practices with the global user communities. I would say a step up in our relationships and the rapport with those agencies started around 2012, when the Generic Drug User Fee Act was signed into law.
To the FDA's credit, they very wisely started to reinvest some of these funds that were coming in from generic drug companies and other organizations around the world, to help advance PBPK science. As mentioned in some of the earlier discussions and in my section of this meeting here, you know, we've been the beneficiary of over 20 grants since 2014, where we've been able to gain access to funding, which has been helpful. But more importantly, we've been able to gain access to data and have that opportunity to build and reinforce these relationships with FDA scientists, both researchers and reviewers.
And, you know, I would say that opportunity has helped us in some ways to influence the directions that the agency was going when they started to draft up some of their guidance documents that were focusing on PBPK science that came out in 2018. So, the relationship with the agency remains very strong today. Just last week, we were there visiting for a full day, updating them on the progress of the 7 grants that we have in 2023, with more to come in 2024. And we look forward to not only continuing to reinforce that partnership with the FDA, but further strengthen the relationships with agencies all around the world.
In brief, if I can just maybe comment on the second part to the question in terms of the barrier to competition. There are lots of different drug molecule types, small molecules, peptides, large molecules, biologics. There are lots of different dosing routes and strategies administration, all around the body. There are lots of different animals and human population groups in which we need to try and simulate and predict the exposure of drug. And you know, I'm really happy to say that GastroPlus has been validated across it all. I mean, that goes back to, I think, the first bullet in the Why We Win section of over 1,000 peer-reviewed publications over the years that reference GastroPlus for all of these different scenarios.
It continues to be validated and qualified through these really strong partnerships with industry, with academia, and with these regulatory bodies all around the world.
Thank you. Our next question comes from Matt Hewitt, from Craig-Hallum. He says: "Thank you for hosting this event. You presented a couple of examples of how use of your software and services have helped either expedite a drug's approval or reduce the development cost. But have you ever done a broader study to determine, on average, how much using simulation can reduce the time and dollars required to get a drug approved?
Thanks, Matt. Good, good question, and you know, having been in this industry for a long time, we've always searched for that simplistic adopt simulation and here's the payback wrapped up in an easy percentage of some sort or dollar amount. You know, the drug development process is a complex, time-consuming, multifaceted process that you know runs 10-15 years, $2 billion of spend, early discovery at the molecular level to testing in the lab, and animal testing through multiple clinical tests of human through to regulatory approval. Modeling and simulation can impact steps all along that continuum.
You know, whether it's a small efficiency in terms of eliminating a couple of potential promising but not quite there molecules in early discovery, whether it's refashioning the protocol for a clinical trial, whether it's better setting that dose regimen for a clinical trial. All along the way, modeling and simulation has impact that can range from something simple and low cost or low benefit in terms of dollar magnitude to high impact in terms of the success of a phase III clinical study. It can address issues that are near to market in terms of a drug's approval and formulation changes that have received bioequivalence waivers through modeling and simulations that get that product to market more quickly. All along the way, there are many ways in which we impact.
It's hard to take the average for those of us in the industry. We're statistical people. You know, the variance is wide. The average, the mean of all of these impacts doesn't really really make sense. I would say that, you know, some measure of the benefit of modeling and simulation and the value that is driven is evidenced through all those anecdotal stories, but as well, in an environment in which drug development spend is growing at a pace of 3%. The investment that our clients are making in modeling and simulation is growing at a pace much, much faster than that. And it's, you know, it's turned the corner of not a nice to do, it's now a must-do in the industry.
So, wish we could come up with a quick formula that produced a simple point answer to the question. We've tried to today, and in our earnings releases, talk more frequently about some of the very impactful success stories of modeling and simulation on a quarterly basis, just to drive home on this point, that what we do can have tremendous impact in terms of a drug program in general and specific drug candidates along the way.
Thank you, Shawn. We have another question from an investor talking about the chatter and updates among biopharma players in terms of program reprioritization, cost cutting, reevaluating of their spend across, various baskets. Are you seeing any of this with your customers? Are you seeing biopharma spending come back? Any slowdown from pharma customers?
Well, a few questions along that sequence there. Try and take them one at a time. Yeah, drug program reallocation, start, stop, is the nature of our business, and that takes place continuously over the years. As new targets are addressed by drugs that get approved, may either increase them in the spotlight or decrease them, depending on the competitive nature. Companies evolve, have successes in their drug programs. When they kill a program, they may be looking to divert to another program. These decisions very impactful use of modeling and simulation and coming to some of these conclusions. It's a continuous process, though. We see that all the time. Is today a more active timeframe in that regard? Perhaps a little bit.
We've got more activity taking place in drug development today. More companies, more change dynamics, resorting of some of the therapeutic areas of interest in terms of their prioritization. Hey, there's a little bit more of that going on. We certainly see it in terms of our pipeline of opportunities that shifts amongst therapeutic areas can change as a company. One of our clients redirects their focus into a different therapeutic area. So yeah, activity is there. Maybe it's up a little bit. Certainly, our activity in terms of our pipeline is up, as evidenced by our fourth quarter results in terms of the backlog growth that we saw. So this change dynamic takes place.
It does settle in the end, and our clients pull the trigger on programs and investments in various therapeutic areas. The market in terms of large pharma, biotech funding, commented on that already a little bit. You know, it's been a slow 18 months, 24 months, slower than norm, macroeconomic environment. Hey, you know, hopefully, as we see the market move today, maybe our segment of the market will change in terms of drug development spend here as well. Certainly, the macroeconomic drivers have had some impact there. And underneath the cover, the funding scenario in terms of biotech has certainly constrained that market segment as well.
But we're seeing some IPO activity taking place there, some funding, capital raise activity in biotech, and perhaps we see a little bit better future for them as well, going forward into the new year.
Okay. We have a couple of questions on PBPK. You mentioned that Congress approved the Modernization Act 2.0 in 2022. How is this impacting or benefiting SLP? And have you seen an increase in clients, new opportunities from existing clients?
Yeah, good question. John, you want to pick up on that one?
I'd be happy to, Shawn, and thank you for the question from that investor. You know, this is not necessarily a new thing. You know, about 10% of our customer base today is in the non-pharmaceutical space. Chemicals, cosmetics, consumer goods companies that have already been told by regulators around the world, especially Europe, that they have needed to greatly reduce or completely eliminate animal testing on some of their products. And so we've actually been able to learn from those relationships, the best ways in which we can position the offerings that we have.
Really, this nice marriage between machine learning and PBPK modeling, to be able to start predicting without any animal data, with reasonable accuracy, what would be the absorption and the exposure of chemicals, or in this case, pharmaceutical drugs, systemically. And so, you know, I think we're really excited now by this formal push by the U.S. Congress, signing into law the fact that, yes, there are real opportunities for pharma companies to be able to use alternatives to animal testing, like computer models, like PBPK simulations. And, we have had companies who have asked us, you know, what is the best path forward to be able to try and show this through the use of the tools under the Simulations Plus umbrella?
Again, from what we've been able to learn earlier in those relationships with the chemicals, cosmetics, consumer goods industries, we've got a path forward for these companies. So we're working with some today on integrating PBPK simulations as early as possible, and if not yet completely eliminating all animal testing, at least greatly reducing the animals that are being sacrificed for certain purposes, and substituting instead with these simulation results. It's only a good thing for PBPK modeling and simulation specifically, but of course, for really all of the solutions that are available at Simulations Plus.
Thank you, John. We have another question from an investor, this time, on AI. Do you see any competitive pressures from the adoption of AI in the development of software that would compete with SLPs?
Spoke earlier in our day about the AI, and certainly a whole lot of activity, a lot of focus. It's a complex topic. Application of AI runs from biomarker identification to the drafting of a report more efficiently, and everything in between. It's an area in which we've participated, as we described, and as we presented our ADMET Predictor capabilities based upon machine learning techniques. And look to continue to evolve our existing solution there and other potential advances in the use of AI, both in terms of our product and service offerings across the scientific domains of PBPK and QSP and pharmacometrics.
AI has tremendous capability to impact data identification, gathering, collection, sorting, and ultimately, the manipulation and data analytics that result in predictive algorithms. And so we look forward to continuing to impact our capabilities using, using advanced AI techniques, and internally as well, from an operational point of view. From a competitive nature, we've seen a number of companies get tremendous funding in the area of drug discovery with AI. Seen some of those companies evolve. That evolution two or three years down the road now, we're seeing some of them show some great success in terms of developing some promising drug candidates. We're seeing some that have not fared all that well, and are starting to pull back a little bit.
We've embraced those companies and partnered with them. They've licensed our AI technology to supplant what they are doing. So we are working with them very closely. Most of those that have been successful have as well become drug companies themselves, and not necessarily AI providers to the industry. They've become drug development companies with their own programs or programs in partnership with existing drug development companies. So these are actually creating customers for us, potential customers, using AI on some of the steps of drug development that are applicable, and then utilizing the tools that are necessary to carry a drug through the full clinical drug development process. So we're very watchful.
I mean, come back to your question, are these investments creating competitive situations? They're certainly creating opportunities, opportunities for some competition to come in, but just as much opportunities for us to enhance our scientific domain products and services, that we supply to the industry, in the long run here. It's an exciting time. We've been in the world of data analytics, for more than 25 years here at Simulations Plus. We've been participating in this world, and enjoy the focus, that recent technological advances in AI have brought to the table and bode well for further expansion and improvement of modeling and simulation in drug development into the future.
Great. Thank you, Shawn. Another question on PBPK: How are customers embracing GPX?
Well, I will hand that to Mr. GPX, internally here, John DiBella. His team has been working hard on this one, and we're looking forward to its arrival here in the next fiscal year. John, you want to throw some more comments about GPX to our audience?
Yeah, thank you, Shawn, and I am really glad somebody asked this question. You know, for 25 years, we have been, as mentioned, laser- focused on the science, and we have established a very strong reputation for accurate simulations for all types of scenarios. It's been then over the last, you know, couple of years where we've decided to make that investment in the next generation platform. So we've got everybody feeling very confident in their abilities to generate accurate predictions with the GastroPlus software.
Now, they would like, and we've listened, to be able to do this in an environment that makes it a lot easier to onboard new users at various company sites, to be able to share project files, to be able to reuse assets within a project, to be able to simulate without any limitations, all scenarios, real-world scenarios, and to make it easier for regulatory agencies to review their submissions, which reference GastroPlus simulations. The excitement is tangible.
The feedback so far from those that have seen it, and we've done lots of demos. We've had external beta testing sessions in place with a number of companies, and universally, the question is back to us: "When can I get my hands on it?" So we are very excited to get this released in the next fiscal year.
We have been very busy working on all of the ancillary documents and training materials and whatnot, and myself and others are getting ready for a very busy travel season in 2024 as we go and visit with just about every company possible all around the world to help them with this transition to the new platform and start putting training programs in place to get more users at their companies onboarded more quickly. So very excited response, very excited and lots of enthusiasm internally, and we're gonna be ready to go in fiscal 2024.
Thank you, John. Our final question today comes from an investor asking that other than directorship, does Walt play any other role in the operation of the company?
Thanks, thanks for the question. Walt continues to provide his sage leadership, having founded the company twenty-five years ago. He lives and breathes SLP. Well, maybe he lives and breathes a little bit of Auburn University, more so today than in the past. But no, Walt, the chairman of the board, and certainly provides invaluable input to the company. From an operational point of view, day-to-day operational point of view, no, Walt serves as chairman of the board and provides his input from that vantage point.
Okay. Thank you for your questions. At this time, we'll now turn the call over to Shawn O'Connor for closing remarks. Shawn?
Thank you, everyone, for your questions. Well, I know we've thrown a lot of information at you today to help you get to know more about us. What we can do can be a mouthful of scientific acronyms, and we were coached to take it easy on you for our first Investor Day. It is our hope we've provided you with insight into our path to win, that will help you to understand our growth prospects as an investment. As you heard, these are exciting times at Simulations Plus. We are unique in our offerings of solutions and services that span the drug development process, and we are growing in exciting areas with significant demand. Our path to win is clear.
Our clients, like pharmaceutical and biotechnology companies and regulators around the world, choose to work with us for our unparalleled offerings and client-centric business model. We are leaders in model-informed drug development because we are focused on areas that our clients find most important. We will continue to lead the industry in ease of use for our software offerings. We will continue to build on our strong relationship-based model to expand existing clients and win new clients. I'll leave you with these key messages. We have a long history of innovation in biosimulation that is transforming drug development and R&D. We have a rich future for growth opportunities. As you saw today, we have a highly experienced scientific leadership team and are aligned with our clients to meet demand for future growth, and we have a strong financial position to fund our growth. Putting clients first drives growth and innovation.
Thank you again for your time today. Please reach out to me or to our investor relations team if you have any follow-up questions. Thanks again.