Evotec Profile
Evotec SE (Evotec) operates as a drug discovery and development partner for the pharmaceutical and biotechnology industry.
The company focuses on data-driven disease understanding, precision medicine and improving disease relevance during the early stages of drug discovery and development to increase probabilities of success up (POS up) and to positively impact patients’ lives. The company’s network includes more than 800 partners ranging from leading pharmaceutical companies, small and large biotechnology companies, academic institutions, patient advocacy groups and venture capitalists as well as mission-driven foundations and not-for-profit organizations. Together with its partners, the company dedicates its work to a wide spectrum of diseases with unmet medical needs, including indications affecting many patients in large parts of the world with little to no access to sufficient care.
To that end, the company has built a comprehensive suite of fully integrated technology platforms with four focus areas: PanOmics-driven drug discovery, discovery applications and off-the-shelf cell therapies based on induced-pluripotent stem cells (iPSC), Just – Evotec Biologics with Artificial Intelligence (AI) and continuous manufacturing for a more cost-efficient access to antibodies and an integrated business-to-business platform for increased probabilities of success from target to the patient (End-to-End Shared R&D). By sharing access to these platforms, the company provides solutions to its partners, which will transform the way new drugs are discovered and which enable significant improvements in the quality of new drugs.
The company’s platforms include AI and Machine Learning (ML) expertise and capabilities such as deep learning and computational knowledge integration along the entire research and drug discovery value chain. The company collaborates with its partners in all early research phases from sourcing novel ideas to early clinical development. The company’s platforms specifically designed for precision drug development and to lead to differentiated results by integration into established R&D capabilities that are leveraged by its experienced scientists. The company’s drug discovery therapeutic area expertise and capabilities include diabetes and its complications, fibrosis, infectious diseases, CNS diseases, oncology, pain and inflammation, immunology, rare diseases, respiratory diseases, and women’s health.
The company’s drug candidates can be created at as low as half the cost of benchmarks for discovery through Investigational New Drug (IND) applications and those generated by industry players, and at a faster speed at up to 30% less time than existing benchmarks for discovery through IND application. Certain of the company’s operations are carried out under GMP and GLP regulations that are certified and periodically audited by regulatory agencies, such as the FDA, MHRA, AISA and its customers.
As of December 31, 2022, Evotec’s work has resulted in 18 disclosed pipeline assets in clinical development, and over 120 pipeline assets in the discovery and preclinical phases.
The company reports the results of its work and collaborations through two operating segments:
EVT Execute: Primarily includes fee-for-service and FTE-rate-based arrangements where the company’s customers own the intellectual property.
EVT Innovate: Includes the company’s internal R&D activities as well as services and partnerships that originate from these R&D activities. In addition to FTE-based revenues, the company generates revenues from milestones and royalties on its pipeline assets.
The company’s End-to-End Shared R&D platform leverages a comprehensive set of capabilities across all stages of discovering new medicines, from initial biological validation and target selection to clinical trial planning, safety assessment and manufacturing. In collaborations where ownership of IP resides with one of the company’s partners, it provides stand-alone or fully-integrated drug discovery and development solutions to its partners. The company’s solutions range across most modalities and from early target identification to the manufacturing of compounds and commercial products.
The company leverages its proprietary technology platforms and related IP to develop new drug discovery projects, assets, and platforms, both internally and through collaborations with leading pharmaceutical and biotechnology companies and academic institutions. These collaborations are typically based on agreements with partners, which involve a combination of upfront payments, ongoing research payments (based on FTE-rates), and significant financial upside through milestones and royalties.
The company also leverages ownership of IP, by making equity investments in products, technology platforms and companies through which it obtains early access to innovation. The company facilitates the acceleration of innovation by providing capital, as well as access to its technology platforms, expertise, and network. As of December 31, 2022, the company had 33 equity engagements with over 120 active projects in its pipelines.
Broad Pipeline of Development
The company initially developed most of the candidates for which it has the right to receive royalty or milestone payments. The company subsequently licensed or assigned those candidates to partners for continued pre-clinical and clinical development. They also include candidates that have been initially developed by its partners and that have become the subject of a joint research project pursuant to which it is eligible for royalty or milestone payments.
Beyond therapeutic areas, the company has also successfully expanded its pipeline across multiple modalities. In 2015, the company’s therapeutic assets were exclusively small molecules. In contrast, in 2022, more than ten assets were derived from cell and gene therapy, more than 20 from biologics, more than 90 from small molecules and more than ten early-stage projects where several modalities are being investigated.
PanOmics data generation—Industrialized high-throughput multi-omics platform.
The company’s approach to precision medicine is based on multi-omics. The company has been particularly focused on industrializing its transcriptomics and proteomics platforms so that they can be fully integrated into its mainstream drug discovery processes. The company’s proprietary multi-omics data generation platform, PanOmics, is industry-leading in terms of throughput, robustness, and cost efficiency, in the fields of transcriptomic and proteomic analysis.
ScreenSeq—High-throughput transcriptomics
The company has built an industry-leading high-throughput transcriptomics platform called ScreenSeq, which is able to run single-cell sequencing analysis on tissues from thousands of patients.
ScreenSeq is run in a 384 well, high-throughput format, designed to run screens of up to 100,000 samples or compounds, which more than covers the requirements for any typical screen. The detection limit is around 15,000 genes, exceeding the requirements needed for most purposes. ScreenSeq works for most tissues from animals or humans, which allows the company to effectively bridge the gap between pre-clinic and clinic.
ScreenPep—High-throughput proteomics
Like ScreenSeq for high throughput transcriptomics, the company’s scientists have developed ScreenPep, providing what is unparalleled throughput in proteomics, while maintaining the highest quality standards regarding proteome coverage and reproducibility. As the proteome provides particularly essential information on the status of a cell or tissue, the company has worked to improve the throughput of its proteomics platform.
E.MPD – Evotec’s Molecular Patient Database
E.MPD Case study: Leading position in the field of CKD
An example of the capabilities of its PanOmics platform is the company’s molecular patient-derived disease database in the field of CKD.
To develop a comprehensive patient derived database in the field of CKD, the company entered a collaboration with the National Unified Renal Translational Research Enterprise (NURTuRE) consortium in the United Kingdom in 2017. NURTuRE brings together a consortium of leading kidney disease companies, academic institutions, and pharmaceutical companies to share and advance cutting-edge disease processes, platforms, and networks to advance research in nephrology. At the start of its collaboration, the consortium had assembled one of the largest CKD databases worldwide with about 4,000 patients comprised of complete clinical patient profiles, including all standard diagnostics and test results as well as treatments. The NURTuRE consortium consists of United Kingdom-based academic institutions coordinated by Kidney Research UK and select industry partners.
Utilizing the PanOmics data generation platforms, the company conducted molecular profiling of patient tissues and samples in the database and thereby generated crucial molecular patient data required to drive precision medicine approaches in CKD. The company has continuously expanded this database, which is based on data from over 10,000 CKD patients. To its knowledge, this constitutes by far the largest CKD patient molecular database worldwide and constitutes more than six hundred billion data points according to the company’s internal calculations.
Based on the strength of its molecular CKD patient database, the company has built four partnerships in kidney diseases in the last five years with prominent pharmaceutical companies, such as Bayer, Novo Nordisk, Eli Lilly, Chinook and CSL via its JV NephThera. The company’s collaborations are structured as multi-target agreements pursuant to which an undefined number of targets may be pursued.
E.MPD - Expanding from CKD to other disease areas.
While its molecular patient database in CKD is the advanced, the company aims to advance several additional proprietary molecular patient databases in other disease areas (e.g., Oncology, Cardiology).
PanHunter — Advanced multi-omics data analysis and prediction platform
Using machine learning, the PanHunter platform helps derive drug signatures or cell-type annotations that serve as references for future studies. In this way, PanHunter provides sophisticated data mining to a wide range of scientists who do not necessarily have a bioinformatics background. It also provides an entry point into more advanced machine learning or AI approaches.
An example of the versatility of PanHunter, here in combination with PanOmics, is the company’s industry-leading position in the prediction of drug-induced liver injury (DILI) given the appropriate inputs. Liver toxicity accounts for about 18% of drug withdrawals from the market.
iPSC
To accelerate the paradigm, shift toward precision medicine, since 2012 the company has developed an industrialized platform that builds patient-derived assay systems and disease models through iPSC technology. The company’s iPSC platform is one of the largest and most sophisticated in the industry, and it has focused on industrializing iPSC-based drug screening so that it can increase the reproducibility and robustness of such screening. The company has achieved industrialization by standardizing and scaling up the process of creating patient-derived iPSC for disease modeling and drug screening.
The company initially developed its iPSC platform to overcome deficiencies associated with disease models for CNS indications but have since expanded its applicability to cover multiple therapeutic areas, such as cardiovascular, metabolic, oncology, endocrinology, and ophthalmology, among others. The company anticipates that iPSC-based disease models will have broad applicability in multiple diseases that have been untreatable due to the absence of robust disease models or due to prior disease models not leading to viable treatment approaches.
iPSC Technology Shifts the Drug Discovery Paradigm
With its iPSC system, animal models are only used for pharmacokinetic and pharmacodynamics studies to determine whether a compound reaches the specific tissue and is effective there. Such compounds are then tested on various patient in vitro models before moving into clinical trial testing. This allows the company to stratify patient populations and explore at the outset whether a drug is effective for all patients or only subpopulations.
For accurate disease modeling, it is essential that all protocols the company establishs work across multiple iPSC lines to capture the highly diverse genetic causes for many diseases. Together with its partners, the company has generated over 350 high-quality iPSC lines according to patient consents and standardized reprogramming methods. The over 350 patient-derived iPSC bank covers a broad range of diseases, including Amyotrophic lateral sclerosis, Frontotemporal dementia, Parkinson’s disease, Huntington’s disease, retinopathies, lysosomal storage diseases and other neurodegenerative diseases. The company is also advancing its stem cell research platform for disease modeling and screening to develop reliable, scalable, and automated manufacturing processes. All its protocols have been simplified, shortened wherever possible and optimized for high reproducibility and cellular yield. This is an essential requirement for large-scale manufacturing in a bioreactor format and the generation of large-scale batches of qualified cells for screening. All cells are seeded onto 384-well plates and handled in an automated fashion.
The company expects that a clinical trial with EVT8683, a small molecule drug candidate derived from a phenotypic screen using an iPSC-based disease model will commence in 2022. The candidate has a novel mechanism in neurodegeneration derived from the company’s iPSC-based disease models. This program is expected to progress to the clinic in less than five years as part of its broad and exclusive neurodegenerative disease collaboration with BMS. More broadly in iPSC, the company has developed over 350 patient-derived cell lines for disease modeling across more than 15 disease areas, for which its main alliances include neurodegeneration and Huntington’s disease. To continue to build its capabilities, the company intends to expand its iPSC capacity in Hamburg, Germany, by constructing a new building The Lighthouse of iPSC with an expected year of completion of 2024.
Just – Evotec Biologics
Just – Evotec Biologics is the company’s advanced approach to designing, discovering, developing, and manufacturing modern bio-therapeutics.
J.DESIGN is the company’s in-house integrated technology platform designed to accelerate development and provide superior manufacturing process control to produce higher-quality molecules at the lowest possible cost. J.DESIGN is directed particularly toward antibody and antibody-like biotherapeutics. One of the key strengths of the platform is the broad scope and integration from discovery through manufacturing and facility design. All operations are integrated under their individual elements, which are known as J.DISCOVERY, J.MD, JP3 and J.POD.
The company is applying AI and ML to create and select high-quality molecules in discovery that in turn drive more productive manufacturing processes. The company anticipates that the current technological focus of the J.DESIGN platform will have the capability to address greater than 70% of all biologic products in the coming years.
J.DISCOVERY—Antibody Discovery
To create antibody therapeutics, it utilizes the company’s J.DISCOVERY approach to build a large and diverse antibody library it calls J.HAL (Just-Humanoid Antibody Library). The DNA sequences coding for the antibodies in J.HAL is computationally created using machine-based deep neural network learning through algorithms termed Generative Adversarial Networks (GANs). The GANs used to build J.HAL are trained on hundreds of thousands of natural human antibody sequences.
J.MD—Molecule Design
J.MD is the molecule design aspect of J.DESIGN that reviews and improves native antibody sequences—derived from either J.HAL or any other source – to enhance their manufacturability and stability. Using Abacus, an in-house suite of proprietary computational tools, the company creates learning algorithms that enable scientists to predict the best molecules and conditions for development.
JP3—Process and Product Platform
JP3 is J.DESIGN’s processing and product design arm complete with proprietary cell lines, vectors, and media with process options for fed-batch, intensified fed-batch, and continuous culture. This technology also includes chromatography, filtration, and viral clearance capabilities for the removal of impurities. To optimize the storage stability of products, JP3 comes with biophysical and formulation development tools. The designing tools also feature high-resolution analytical capabilities including a mass spectrometry-based multi-attribute method (MAM).
J.POD—Manufacturing and Plant Design
The company has established agreements with Advanced BioScience Laboratories, Inc. (ABL) and Ology Biosciences in 2020. ABL is a global contract development and manufacturing organization (CDMO) that services both the U.S. government and the biopharmaceutical industry. Under the agreement, Just – Evotec Biologics will design a manufacturing process required to produce Phase I current Good Manufacturing Practice (cGMP) clinical supply of a broadly neutralizing antibody (bnAb) against HIV. The agreement with Ology Biosciences covers the evaluation and analytical characterization of antibodies against SARS-CoV-2. Under the terms of the agreement with Ology Bio, Just – Evotec Biologics acts as a subcontractor to Ology Bio and utilizes its in silicon toolset to screen a panel of anti-SARS-CoV-2 antibodies provided by Ology Bio that were generated from convalescing COVID-19 patients.
In August 2022, Just – Evotec Biologics, expanded its multi-year partnership with Alpine Immune Sciences for the development of a commercial process for ALPN-303, an engineered TACI domain with significantly improved potency against the B cell cytokines BAFF and APRIL, being developed for the treatment of systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases. The contract is a continuation of the first-in-human program initiated in 2020 in which Just – Evotec Biologics delivered drug substance materials using the J.DESIGN continuous manufacturing platform for Alpine’s ongoing Phase I study and anticipated Phase II studies of ALPN-303. Under the expanded contract, Just – Evotec Biologics will leverage its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. The program includes upstream and downstream processes, analytical methods, and formulation development with a view to supporting commercial manufacturing of ALPN 303.
iPSC-based off-the-shelf cell Therapies Based on Induced-Pluripotent Stem Cells
In addition to disease modelling, the company uses its iPSC platform to develop the next generation of cell-based therapies. The company’s iPSC cell therapy portfolio spans metabolic diseases, immuno-oncology, and heart repair. The company plans to further expand and invest in its cell therapy infrastructure with a focus on off-the-shelf cell therapies with long-lasting efficacy like immune cells in oncology (e.g., Natural Killer T cells), beta cells for diabetes, cardiomyocytes in heart repair, and retina cells in ophthalmology as well as iPSC-derived exosomes. The company has expanded its cGMP production capacities with the acquisition of Rigenerand (operating under Evotec Modena Srl.) offering the ability to scale up and accelerate development of material sufficient to run phase II clinical trials.
The company’s most advanced candidate in the field of iPSC-based regenerative medicine is its QRBeta initiative, aimed to cure patients suffering from type I diabetes. In in vivo models, the company has demonstrated a durable normalization of blood glucose levels with its iPSC-derived islet-like clusters that can also confer long-lasting normoglycemia at human glucose set points. s The first generation of iPSC based regenerative medicines in diabetes was partnered in May 2022. On 17 May, Evotec and Sernova announced an exclusive strategic partnership for iPSC-based beta cell replacement therapy. The company’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch, a medical device enabling vascularization of the cell implant and thus ensures long-term survival and optimal function in patients. The decision was made based on favorable results seen from the combination of primary donor islets and Cell Pouch, which has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial. Meanwhile, visible progress has been achieved in its project together with Sernova:
In 2021, the company advanced its cardiomyocytes-based program by entering a collaboration with the University Medical Centre Hamburg-Eppendorf, UKE. The collaboration was formed to develop a first-in-class cell therapy for the treatment of heart failure. The company will be responsible for GMP and pre-clinical activities, as well as for any potential subsequent collaboration with a commercial partner for this program.
In immuno-oncology, the company is building a portfolio of off the shelf iPSC-derived immune effector cells to overcome the hurdles of autologous cell therapies in oncology. In the future, the company plans to target the development of a comprehensive portfolio of innovative immuno-oncology programs.
End-to-End Shared R&D - Integrated business-to-business platform for increased probabilities of success from target to the patient
The company’s End-to-End Shared R&D platform, differentiates it from competition as the organization is able to deliver fully integrated drug discovery and development programs to its partners. The company’s platform possesses capabilities across the early stages of discovery, including modern methods for molecule design, biomarker selection, human pharmacokinetics (PK) testing, clinical trial planning, safety assessment and manufacturability in the early stages of precision medicine discovery. This is achieved by seamlessly integrating firmly-established R&D capabilities, such as screening platforms, deep disease knowledge and translational models, with cutting-edge proprietary technologies that can—in combination with knowledge of its experienced scientists—result in significantly improved speed.
The company’s expertise in deep learning and computational approaches and the integration of such knowledge across the full value chain of drug discovery and development are industry-leading. The company possesses computational capabilities in the essential aspects of drug discovery and early development, including, for example, molecular design, product optimization, extensive human pharmacokinetic parameters and dose predictions, toxicity prediction and design tools. The company’s biomarker strategy and resources provide tailor-made biomarker solutions using state-of-the-art technologies. From its position of strength in chemistry and small molecules, the company has added capabilities for additional modalities, such as biologics, proteins, RNA, and antibody-drug conjugates. The company’s drug discovery therapeutic area expertise and capabilities covers diabetes and its complications, fibrosis, infectious diseases, CNS diseases, oncology, pain and inflammation, immunology, rare diseases, respiratory diseases, and women’s health. Continuous training in technology and leadership for scientists at all levels is designed to meet or exceed industry standards.
At Evotec, the company approaches drug discovery and development as a continuum instead of disparate processes. The company focuses on problem solving and careful planning at the very earliest stage to design for the maximum potential success of subsequent clinical development. By focusing on the continuum, it allows for smooth transitioning from discovery and preclinical development into the clinic through the company’s INDIGO solution. Within the structure of a project or partnership, the company focuses on the success of the inventive step in every discipline through a combination of knowledge, experience, computational power, and process excellence.
Business models
The company’s business model is based on three value-creating pillars.: A “Fee-for-service” and FTE-based funding model; Pipeline building and EVOequity.
Fee-for-service and FTE-based funding model
Revenues consist mainly of service fees and FTE-based research payments.
The company maintains a large portfolio of partnered pipeline assets generating revenues from upfront and milestone payments, as well as several unpartnered pipeline assets that it is progressing for future partnering.
As an external innovation partner to the life science industry, the company provides stand-alone or fully integrated drug discovery and development solutions to its partners using its industrialized, high quality and comprehensive infrastructure. Various capabilities can be grouped into an integrated service combining various steps along the drug discovery and development chain. The fee-for-service model usually applies where no intellectual property of Evotec is involved or no essential proprietary technology platforms (e.g., PanOmics, PanHunter, iPSC, proprietary molecular patient data) are used.
The company’s solutions can provide unparalleled breadth and depth to clients. The company can support its partners’ programs at all phases of the chemical value stream (hit creation, expansion, hit-to-lead, lead optimization and development readiness) and from early target identification through to the manufacturing of compounds for clinical and commercial purposes. The company also possesses capabilities across all modalities, target types, routes of administration and disease areas. Typical examples of fee-for-service work packages would include, without limitation, high-throughput screening campaigns, sample management, ADME-tox tests or certain chemistry development services.
In addition, to reflect the unpredictable nature of multi-year research efforts, many fully integrated projects with partners are structured around flexible FTE pools, compensated at blended FTE rates. Progress is monitored closely through active project management and joint steering committees with the partner, thus ensuring the most relevant science and capabilities are brought to bear against the needs of the project at the right time.
In 2022, 73% of the company’s third-party revenues were derived from EVT Execute, which mainly includes fee-for-service and FTE-rates-based revenues. Just – Evotec Biologics is also recognized within EVT Execute. Most revenues are still derived from FTE rates and FFS contracts. Gradually, revenues derived from manufacturing add to total segment revenues.
FTE-rates-based revenues are also a source for revenues within EVT Innovate, in addition to milestones and potential royalties. Driven by favorable market dynamics and robust demand for pharmaceutical outsourcing services, the company expects the fee-for-service and FTE-rates-based business to grow by mid to high single digits in the near term. Fee-for-service and FTE-rates will continue to remain a value driver going forward but as drug discovery and development evolve, it foresees certain work packages transitioning away from fee-for-service into more integrated alliances.
With an increase in demand for Evotec’s proprietary and premium platforms, (e.g., PanOmics and PanHunter, molecular patient data and iPSC drug discovery), it has sought to enter contracts with customers for these services that expand beyond FTE rates to also include success-based components, such as milestones and potential royalties. As an example, target identification and validation services have historically been offered on an FTE-rates basis. However, with transcriptomic and proteomic profiling across cells and tissues followed by bioinformatics-driven data mining and hypothesis building potentially becoming the new gold standard, these services involve the company’s proprietary and premium platforms. In connection with such platforms, the company seeks to structure integrated alliances in which it will generate FTE-based revenue from the delivery of services, as well as potential milestones and royalties. The most prominent example of such an evolution is the company’s alliance with BMS targeting neurodegenerative diseases, which has so far resulted in a first clinical phase I trial with additional assets being progressed in the discovery and development stages.
Key Performance Metrics for Fee-for-Service and FTE-based Business models
Pipeline building—Co-owned and Shared assets
The company leverages its proprietary technology platforms to develop new drug discovery projects, assets, and platforms, both internally and through collaborations. This approach allows the company to create starting points for the later development of strategic partnerships with leading pharmaceutical and biotechnology companies. These collaborations generally involve a combination of upfront payments, ongoing research payments, and significant financial upside through milestones and royalties. They enable the sharing of cost and risk. The aim of these collaborations is to develop R&D projects faster and more efficiently and to generate faster returns on investments. With an increasing demand for its proprietary technology platforms, it expects to enter collaborations involving success-based milestone payments and royalties.
As of December 31, 2022, of the pipeline assets, one obtained approval in South Korea, two of the clinical programs were in Phase III, four were in Phase II, one in Phase I/II and eleven were in Phase I. The company defines its pipeline to include candidates that it wholly owns and those for which it has the right to receive royalty or milestone payments. For candidates for which, the company has the right to receive royalty or milestone payments, it, in most cases, will have initially developed them and subsequently licensed or assigned to partners for continued pre-clinical and clinical development. They also include candidates that have been initially developed by its partners and that have become the subject of a joint research project pursuant to which it is eligible for royalty or milestone payments. Beyond therapeutic areas, the company has also successfully expanded its pipeline across multiple modalities.
Pipeline Projects
The company’s partnered pipeline includes those assets it has developed and licensed or assigned to partners for clinical development and commercialization, as well as the assets of its partners for which it is entitled to receive potential royalty or milestone payments (dark blue boxes). The company’s unpartnered pipeline consists of assets it is developing internally but with whom it has not yet partnered.aiur equity pipeline consists of the assets under development by companies in which it has made an equity contribution through EVOequity. The company expects to realize returns on its equity pipeline primarily from successful exits but also from fee-for-service and FTE-rate-based revenues from these companies. The company’s RIDGES pipeline represents the assets under development through its joint ventures with academic institutional partners as part of its project incubation program to promote the early development of academic research. Note that the assets shown here as part of its equity and BRIDGEs pipelines are not included in the number of its pipeline assets described elsewhere in this annual report.
EVOequity
The company makes equity investments in products, technology platforms and companies through which it obtains early access to innovation and derive upside through its role as an operational partner.
As shown in the graphic below, the company recognizes various starting points to fuel its EVOequity portfolio. One of the key sources is risk-shared venture creation involving spinouts of its proprietary assets into separate legal entities or joint ventures with partners. The company also invests in early-stage development companies that start out as its customers and engage it to conduct for them drug discovery work on its platforms. Investing in those companies helps it create long-term relationships and facilitates access to innovation in the treatment areas in which the company specializes. These companies may originate from its BRIDGEs program, where Evotec collaborates with academic institutions to facilitate the acceleration of academic innovation without compromising precision or safety.
EVOequity’s strategy started with the creation of Evotec’s spinouts of Topas Therapeutics in 2016. Since then, its portfolio of equity holdings has grown steadily, and as of December 31, 2022, the company had 33 equity engagements with 120 active projects in its EVOequity pipeline. Most projects are in oncology, immunology, and inflammation. Assets from Carrick Therapeutics, Exscientia, Immunitas and Topas Therapeuticsare the most advanced, with seven projects having reached the clinical stage (Phase I and II).
Many of the company’s portfolio companies have started out as its customers or have become customers either in parallel or after its equity investment. For example, Vifor Pharma – Now CSL Ltd. – has been a customer of Evotec for many years, and more recently, the company has collaborated on early development in nephrology, which has led to the establishment of its joint venture, NephThera. In 2022, Vifor was acquired by CSL Ltd.., and continued collaborating with it on unchanged terms. With other equity holdings such as Blacksmith and Aeovian, it has an operational relationship through signing a master service agreement in parallel to its investment into the company.
Typically, the company supports the development of its equity investors’ in-house projects from early discovery up to IND-enabling studies and chemistry, manufacturing, and control
BRIDGEs
The company has positioned itself as a leading company for the accelerated translation of academic assets by initiating BRIDGEs, its project incubation program designed to accelerate and promote the early development of academic research. BRIDGEs stand for Biomedical Research, Innovation and Development Generation Efficiency. Through BRIDGEs, the company utilizes its technology platforms to facilitate the acceleration of academic innovation. The global rollout of BRIDGEs is underway with a geographic focus on North America and Europe and Asia as an expansion target. BRIDGEs provide the company with access to a broad portfolio of first-in-class therapeutics across academic institutions. The company serves as the exclusive technology partner to advance projects to the next value inflection points, which enables the formation of spinout companies or collaboration with pharmaceutical companies. The entire process facilitates the decision-making process of investors trying to assess the quality of the respective projects. Through BRIDGEs, the company has achieved a significant reduction in average project evaluation time an accelerated path from plan to first experiments and a speedy progress towards conclusion of experiments on industry-best-practice platforms..
Operationally, BRIDGEs fall into two categories: Contractual partnerships with academic institution(s) and investors or pharma companies and (ii) equoty investments into start-up studios which focus on accelerating academic projects. As of December 31, 2022 , the company ve created six BRIDGE partnerships (LAB282, LAB150, beLAB2122, LAB1407, Danube Labs and a BRIDGE with Amplitude) and three investments into start-up studios (Autobahn Labs, Argobio and Extend). A spinout from the University of Oxford called Dark Blue Therapeutics originated entirely from LAB282.
LAB282
In November 2016, the company announced the formation of LAB282, a research laboratory developed in partnership with Oxford University Innovation and Oxford Sciences Innovation (OSI). Housed at Oxford University, the lab is dedicated to accelerating the translation of basic biomedical research from Oxford University into new therapeutics across any therapeutic area or modality. Projects are sourced exclusively from Oxford University researchers and are aided by a drug discovery expert in residence seconded by Evotec to the lab.
Autobahn Labs
In June 2020, the company announced the launch of Autobahn Labs, a novel virtual incubator developed in partnership with Samsara BioCapital, a leading life sciences investment firm and KCK Ltd., a family investment fund. Autobahn Labs operates out of the San Francisco area and partners with top academic and research institutions to catalyze early-stage drug discovery and development. Since launch, Autobahn Labs has established multiple strategic collaborations with leading research institutions, including a first-in-kind collaboration with the University of California Los Angeles to identify and advance patient therapies for a variety of indications and another collaboration with the University of California San Francisco to identify promising early science and form new joint-owned ventures. Autobahn Labs has two active or completed projects to date.
beLAB2122 / beLAB1407
In April 2021, the company announced the launch of beLAB2122 and in May 2021, it announced the launch of beLAB1407. In collaboration with BMS, beLAB2122 brings together leading academic institutions from the Rhine-Main- Neckar region of Germany. Also, in collaboration with BMS, beLAB1407 brings together leading academic institutions from the Midlands in England and Scotland.
Intellectual Property
As of December 31, 2022, the company owned patent portfolio included more than 60 patent families, each of which includes at least one filing in the United States or Europe, and several of which are pending or granted in multiple jurisdictions.
Below, the company provides a summary of the contours of its intellectual property portfolio as it relates to different aspects of its business.
Discovery Platform
The company’s discovery platform consist of multiple integrated building blocks. These combined platforms allow the company to deliver operational efficiencies and advanced technological capabilities to drive rapid progress and successful outcomes in the early stages of the R&D process where innovation steps are the largest and most important. In support of its discovery platform, the company owns a patent estate for molecular detection and other platform technologies. In addition, the company has developed several patent-protected biological assays, specifically, methods to measure the chemical or biological activity of any combination of targets and compounds.
In support of its discovery platform, the company owns proprietary trade secrets and methods for analyzing samples. PanOmics is the company’s proprietary approach to analyzing samples from human patients, rodents and in vitro cultures using genomics, transcriptomics, proteomics, and metabolomics. The company has proprietary protocols, that it protects as trade secrets, which have been established and validated to allow for the preparation of fully intact RNA, metabolites, and proteins from several tissues from both rodent models and human patient material that are in many cases unique to Evotec. The company has primary and other cell types, and proprietary immortalized cell lines that it processed in a way to allow it to perform single-cell and single-nuclei sequencing, as well as so-called ScreenSeq and ScreenPep analysis. The company’s proprietary ScreenSeq and ScreenPep technologies are process-optimized and fully validated high-throughput transcriptomics and proteomics platforms, respectively. The company has a growing proprietary database comprising diverse proprietary -omics data based on in vitro, in vivo, and human sample analysis.
The company owns and leverages proprietary software and datasets. PanHunter is the company’s proprietary software solution that enables exploratory insight analysis for researchers in a convenient, web-based environment. The company’s software may integrate some open-source software and openly available published algorithms with its proprietary modules and data. The company’s proprietary modules include an infrastructure to map and interlink meta information for e.g., genes, proteins, or targets within omics data and across species barriers, a framework to store, manage, and access omics data, and an architecture for storing, cleaning, managing, and providing access to clinical data. The software includes several tools to enhance analysis, including tools for differential analysis (e.g., used to compare diseased vs. healthy samples), statistical analysis tools, and a machine learning computing tool. The PanHunter software leverages the company’s proprietary datasets to create a prediction model for cell-type annotation.
In support of its discovery platform, the company has proprietary materials and cells. EVOcells is the company’s proprietary cell lines platform and includes its proprietary iPSC platform. The company expanded its iPSC platform through the acquisition of diverse assets including intellectual property from third parties.
Pipeline Assets
The company has used its proprietary research platform to generate and identify patentable drug candidates with the potential for collaboration. Numerous patent applications have been generated and filed because of such activities. In some cases, the company has elected to retain the pipeline asset intellectual property, and in other cases, it has out-licensed its intellectual property to third parties or transferred ownership of the intellectual property to third parties in exchange for milestone payments, royalties, or equity in their business.
Growth Strategy
The key elements of the company’s strategies include establishing Evotec as the premier innovator to discover and develop new medicines with partners; strengthening its position as the premier partner to the life sciences sector; expanding the value of co-owned assets; disrupting the biologics ecosystem through Just – Evotec Biologics toward access to medicines; identifying risk-balanced, high-reward opportunities through equity investments; and leveraging the synergies between Evotec’s businesses.
Government Regulation
The Federal Food, Drug, and Cosmetic Act; the Public Health Service Act; and other federal and state statutes and regulations apply to the company, its customers, and its partners who develop its pipeline assets.
The company’s facilities are audited by regulatory agencies, such as the FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and similar foreign regulatory authorities, as well as its customers to ensure compliance with requirements designed to ensure the quality and integrity of the testing process and data, such as Good Laboratory Practice (GLP) and GMP and other requirements adopted by the EMA, the FDA, the Ministry of Health in the United Kingdom and by similar regulatory authorities in other countries, as applicable.
Research and Development
In 2022, the company invested €76.6 million in R&D.
Competition
Pipeline Assets: The company’s agent for the treatment of Chikungunya virus infections faces competition from an Albumedix product with the same application.
History
Evotec SE was founded in 1993. The company was incorporated in 1993 under the laws of Germany.
