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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 20-F

(Mark One)

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from       to       .

OR

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

Commission file number 001-34041

Evotec SE

(Exact name of Registrant as specified in its charter)

Not applicable

(Translation of Registrant’s name into English)

Federal Republic of Germany

(Jurisdiction of incorporation or organization)

Essener Bogen 7

22419 Hamburg

Germany

Tel: +49 40 560810

(Address of principal executive oces)

Dr. Werner Lanthaler

Essener Bogen 7

22419 Hamburg

Germany

Tel: +49 40 560810

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class

    

Trading
Symbol(s)

    

Name of each exchange
on which registered

American Depositary Shares, each representing one-half of one ordinary share

EVO

The NASDAQ Global Select Market

Ordinary shares, no par value per share*

 

 

The NASDAQ Global Select Market

* Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None.

(Title of Class)

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

None.

(Title of Class)

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of outstanding ordinary shares as of December 31, 2022 was 176,952,653.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes    No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes    No

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes    No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes    No

Indicate by check mark whether the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large, accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Emerging growth company

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. 

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the eectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by checkmark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240. 10D-1(b).

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP

International Financial Reporting Standards as issued by the International Accounting Standards Board

Other

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17   Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes    No

Table of Contents

TRADEMARKS, SERVICE MARKS AND TRADE NAMES

1

PRESENTATION OF FINANCIAL INFORMATION

1

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

1

Summary of Risks Associated with our Business

2

PART I

4

Item 1.

Identity of Directors, Senior Management and Advisors

4

A.

Directors and senior management.

4

B.

Advisers.

4

C.

Auditors.

4

Item 2.

Offer Statistics and Expected Timetable

4

A.

Offer statistics.

4

B.

Method and expected timetable.

4

Item 3.

Key Information

4

A.

[Reserved]

4

B.

Capitalization and Indebtedness

4

C.

Reasons for the Offer and Use of Proceeds

4

D.

Risk Factors

4

Item 4.

Information on the Company

16

A.

History and Development of the Company

16

B.

Business Overview

17

C.

Organizational Structure

53

D.

Property, Plants and Equipment

53

Item 4A.

Unresolved Staff Comments

55

Item 5.

Operating and Financial Review and Prospects

55

A.

Operating Results

55

B.

Liquidity and Capital Resources

70

C.

Research and Development, Patents and Licenses

74

D.

Trend Information

74

E.

Critical Accounting Estimates

74

Item 6.

Directors, Senior Management and Employees

74

A.

Directors and Senior Management

74

B.

Compensation

77

C.

Board Practices

100

D.

Employees

105

E.

Share Ownership

105

Item 7.

Major Shareholders and Related Party Transactions

106

A.

Major Shareholders

106

B.

Related Party Transactions

107

C.

Interests of Experts and Counsel

107

Item 8.

Financial Information

107

A.

Consolidated Statements and Other Financial Information

107

B.

Significant Changes

108

Item 9.

The Offer and Listing

108

A.

Offer and Listing Details

108

B.

Plan of Distribution

108

C.

Markets

108

D.

Selling Shareholders

108

E.

Dilution

108

F.

Expenses of the Issue

108

Item 10.

Additional Information

108

A.

Share Capital

108

B.

Memorandum and Articles of Association

108

C.

Material Contracts

110

D.

Exchange Controls

110

E.

Taxation

110

F.

Dividends and Paying Agents

123

G.

Statements by Experts

123

H.

Documents on Display

123

I.

Subsidiary Information

123

Item 11.

Quantitative and Qualitative Disclosures about Market Risk

123

Item 12.

Description of Securities Other than Equity Securities

125

A.

Debt Securities

125

B.

Warrants and Rights

125

C.

Other Securities

125

D.

American Depositary Shares

125

PART II

127

Item 13. Defaults, Dividend Arrearages and Delinquencies

127

Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds

127

Item 15. Controls and Procedures.

128

Item 16. [Reserved]

130

Item 16A. Audit Committee Financial Expert

130

Item 16B. Code of Ethics.

131

Item 16C. Principal Accountant Fees and Services.

131

Item 16D. Exemptions from the Listing Standards for Audit Committees.

132

Item 16E. Purchases of Equity Securities by the Issuer and Aliated Purchasers.

132

Item 16F. Change in Registrant’s Certifying Accountant.

132

Item 16G. Corporate Governance

132

Item 16H. Mine Safety Disclosure.

134

Item 16I. Disclosure Regarding Foreign Jurisdictions that prevent Inspections

134

PART III

135

Item 17. Financial Statements.

135

Item 18. Financial Statements.

135

Item 19. Exhibits.

135

SIGNATURES

137

TRADEMARKS, SERVICE MARKS AND TRADE NAMES

Evotec, the Evotec SE logo, EVT, Just, the Just logo, J.POD, J.HAL, J.HAL HUMANOID ANTIBODY LIBRARY, JP3, Aptuit, the Aptuit logo, Evotec INDiGO, Aptuit INDiGO, Cyprotex and other trademarks or service marks of Evotec appearing in this annual report are the property of the Company. Solely for convenience, some of the trademarks, service marks, logos and trade names referred to in this annual report are presented without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This annual report contains additional trademarks, service marks and trade names of others. These trademarks, service marks and trade names may be the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights, or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

PRESENTATION OF FINANCIAL INFORMATION

The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) and its interpretations as issued by the International Accounting Standards Board (IASB), as adopted by the European Union (EU) and additionally as issued by the IASB. Our financial information is presented in Euros. For the convenience of the reader, we have translated some of our financial information into U.S. dollars. Unless otherwise indicated, these translations for the financial information as of and for the years ended December 31, 2022, and 2021 were made at the rate of €1.00 to $1.0666, obtained from the European Central Bank on December 31, 2022. The exchange rate is based on a regular daily concentration procedure between central banks across Europe and worldwide, which normally takes place at 2:15 pm Central European Time. Such U.S. dollar amounts are not necessarily indicative of the amounts of U.S. dollars that could have been purchased upon exchange of Euros at the dates indicated. All references in this annual report to “$” mean U.S. dollars and all references to “€” mean Euros. Throughout this annual report, references to “ADSs” mean American Depositary Shares or ordinary shares represented by American Depositary Shares, as the case may be.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This annual report contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Many of the forward-looking statements contained in this annual report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and other similar expressions that are predictions of or indicate future events and future trends, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors, including, but not limited to, those identified in the section titled “Risk Factors” in this annual report. The forward-looking statements in this annual report include, among others, statements regarding:

Our ability to innovate sufficiently and continually remain at the forefront of precision medicine, including with respect to our platform technologies and our investment into the discovery of new pipeline assets, such that we retain our existing customers, broaden, and deepen our customer relationships and gain new customers,
Our ability to find suitable partners or agree on acceptable terms regarding our unpartnered pipeline assets,
The ability and timing of our partners to develop successfully, conduct trials of, obtain regulatory approval for and commercialize our pipeline assets,
Our ability to allocate resources properly, retain the business of our existing customers, and successfully manage the expansion of our company, including with respect to our investments through EVOequity,
Whether we can obtain a positive return on our equity investments,

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The impact of the COVID-19 pandemic and any similar pandemic, epidemic or outbreak, on our business, financial condition, results of operations, cash flows and prospects,
The Russia-Ukraine war and all its impacts such as significantly increased energy prices and transport costs as well as supply bottlenecks and delays, growing risks of cyber attacks, and risks of production interruptions at our sites, particularly because of restricted energy supplies,The impact on our results of operations and cash flows from period to period is affected by fluctuations in foreign exchange rates,
Our ability to comply with the applicable laws and regulations, export and import controls, sanctions, embargoes, anti-corruption laws and anti-money-laundering laws and SOX,
Our ability to secure our information technology systems and the data stored therein, and prevent and remediate cyber security incidents,
Our ability to obtain the substantial additional financing required to achieve our goals,
Our ability to take advantage of R&D tax credits, grants, and tax loss carryforwards, and
Our ability to obtain sufficiently and timely, maintain, protect, defend and/or enforce our intellectual property rights.

The preceding list is not intended to be an exhaustive list of all our forward-looking statements. The forward-looking statements contained in this annual report speak only as of the date of this annual report, and unless otherwise required by law, we do not undertake any obligation to update them considering new information or future developments or to release publicly any revisions to these statements to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this annual report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

Summary of Risks Associated with our Business.

Our business is subject to several risks which you should be aware of before making an investment decision. These risks are discussed more fully in the section of this annual report titled “Risk Factors”. These risks include, but are not limited to, the following:

Our business is subject to the significant and increasing challenges that face the pharmaceutical and biotechnology industries,
Our business depends on our and our partners’ success in innovation and drug development, which is highly uncertain,
Drug discovery and innovation are subject to significant risks and increasing challenges,
Our operational business faces various performance-related risks,
We intend to develop and expand our company, and we may encounter difficulties in managing our development and expansion efforts, which could disrupt our operations,
We may not realize a return on our equity investments,
Our success depends on our ability to attract and retain senior management and key employees, including highly specialized scientific staff,

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Our partners and we face intense competition in the biotechnology and pharmaceutical industries,
The approval and sale of drug products are subject to extensive regulation, and accordingly our ability to generate revenue from our pipeline assets is uncertain,
Even if any of our pipeline assets are commercialized, they may not be accepted by physicians, healthcare payors, patients, or the medical community in general,
Our ability to comply with the applicable laws and regulations, export and import controls, sanctions, embargoes, anti-corruption laws, anti-money-laundering laws and SOX,
The Russia-Ukraine war and all its impacts such as significantly increased energy prices and transport costs as well as supply bottlenecks and delays, growing risks of cyber attacks and risks of production interruptions at our sites, particularly because of restricted natural gas supplies,
Our efforts to obtain, maintain, protect, defend and/or enforce our intellectual property may be inadequate and our business could be adversely affected as a result,
Our activities, and the activities of our customers, are and will continue to be subject to extensive government regulation to ensure patient health, and
Our ability to accurately report our financial results or prevent fraud if we fail to maintain an effective system of internal control over financial reporting.

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PART I

Item 1.                 Identity of Directors, Senior Management and Advisors

A.  Directors and senior management.

Not applicable.

B.  Advisers.

Not applicable.

C.  Auditors.

Not applicable.

Item 2.                 Offer Statistics and Expected Timetable

A.  Offer statistics.

Not applicable.

B.  Method and expected timetable.

Not applicable.

Item 3.                 Key Information

A.  [Reserved]

B.  Capitalization and Indebtedness

Not applicable.

C.  Reasons for the Offer and Use of Proceeds

Not applicable.

D.  Risk Factors

Risk Management

Our business faces significant risks and uncertainties. You should carefully consider all of the information set forth in this annual report and in other documents we file with, or furnish to, the SEC, including the following risk factors, before deciding to invest in or to maintain an investment in our securities. Our business, as well as our reputation, financial condition, results of operations, and share price, could be materially adversely affected by any of these risks, as well as other risks and uncertainties not currently known to us or not currently considered material.

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Strategic risks

Failure to achieve strategic targets.

Currently, we have close to 5,000 employees and, in connection with the growth and advancement of our pipeline, we expect to increase the number of employees and the scope of our operations. To manage our anticipated development and expansion, we must continue to implement and improve our managerial, operational, legal, compliance and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. Our management may need to divert a disproportionate amount of its attention away from its day-to-day activities and devote a substantial amount of time to managing these development activities. We are actively developing pipeline assets in many therapeutic areas and across a wide range of diseases. We also routinely pursue new service offerings, such as our expansion into Contract Research Organization (“CRO”) services including, but not limited to, protocol preparation and review and regulatory preparation and submission. Successfully developing candidates for, and fully understanding the regulatory and manufacturing pathways to, all these therapeutic areas and diseases requires a significant depth of talent and experience, resources, and corporate processes to allow simultaneous execution across multiple areas. In case of limited resources, we may not be able to effectively manage this simultaneous execution and the expansion of our operations or recruit and train additional qualified personnel. This may result in weaknesses in our infrastructure, give rise to operational mistakes, legal or regulatory compliance failures, loss of business opportunities, loss of employees and reduced productivity among remaining employees. For example, by expanding into CRO services, we may become liable for acts or omissions made in connection with developing clinical protocols. The physical expansion of our operations may lead to significant costs and may divert financial resources from other projects. If our management is unable to manage effectively manage our expected development and expansion, our expenses may increase more than expected, our ability to generate or increase revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance and our ability to compete effectively will depend in part on our ability to effectively manage our future development and expansion. To achieve our strategic targets, we above all must continue to expand our top-quality, innovative services.

Future risks to success in drug discovery and development

We seek to serve as a source of innovative drug candidates to potential partners. We are advancing several active discovery and early-stage development assets that we intend to license to partners for clinical development and commercialization. Some of our assets are not partnered, and if we cannot find a suitable partner or agree on acceptable terms with a partner, we may not be able to generate a return on such assets. Furthermore, the amount of our return on the investments in our own pipeline assets depends on many factors, such as the degree of innovation and strength of our intellectual property position, as well as on external factors outside of our control. For example, our ability to generate a return on the investments in our pipeline assets depends, in significant part, on our partners’ R&D priorities. The market environment, demand and competitive landscape for our individual pipeline assets might change significantly over time as certain diseases become prevalent or other treatment options are demonstrated to be safer and more effective or become more readily available, thereby reducing the market opportunities for our pipeline assets in development. As a result, the commercial objectives of our partners with respect to individual assets and the financial proceeds we may receive from partnering individual assets are highly uncertain, subject to factors outside of our control and could deviate significantly from our projections. Whether we are eligible to receive milestone and royalty payments is subject to our partners’ success in pre-clinical and clinical testing. The outcome of respective tests and trials is inherently uncertain, and we neither control nor drive the development process once our partners enter the clinical trial phase. Our partners also may experience unforeseen challenges during, or because of, any clinical trial that they conduct. This could significantly delay or even prevent successful product development and subsequent market approval. Furthermore, there is a risk that milestone and potential license payments on future drug sales by partners will be lower than anticipated in our strategic planning. This could thus lead to impairments of underlying individual intangible assets, affecting our financial position and jeopardizing the corresponding strategic target in the medium to long term.

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Political risks

Political risks, which Evotec considers to be strategic risks, mainly include geopolitical decisions that lead to global trade conflicts or an uncertain economic situation. In February 2022, Russia launched an invasion of Ukraine. The ongoing armed conflict is having a significant impact on the global economy and financial markets and increases the risk that the current economic challenges will not only persist but intensify in the future. The direct impact of the Russia-Ukraine war has been minor due to Evotec’s limited business relationships in Russia, Ukraine and Belarus and is not expected to pose a major risk to Evotec in the near-term future. However, there are currently noticeable indirect effects, the impact and development of which are difficult to assess. The Russia-Ukraine war has led to a further deterioration of the macroeconomic environment which, due to a persistent inflationary market situation, significantly increased energy prices and transport costs as well as supply bottlenecks and delays, resulting in additional cost burdens and considerable planning uncertainties for Evotec. As global capital markets are in a state of sustained upheaval characterized by rising interest rates and credit spreads as well as higher volatilities, Evotec faces increased counterparty risk through constraints on customers’ ability to pay. The challenging capital market situation could complicate the required refinancing initiative from early-stage biotech companies who are a relevant customer class from Evotec. The potential risk of losing revenues as a result requires continuous monitoring of our customers. There may be significant risks of production interruptions at our sites, particularly because of restricted natural gas supplies. For example, in September of 2022, a series of explosions interrupted the operations of the Nord Stream 1 and 2 natural gas pipelines linking Russian natural gas supply to Germany.

Disruptive market participants

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We face the risk that new market entrants and existing competition may try to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete. In addition, our drug discovery and development efforts may target diseases and conditions for which there are existing therapies or therapies that are being developed by our competitors, which may have e.g., greater resources or superior manufacturing capabilities than we do. Further, any drug products resulting from our research and development (“R&D”) efforts might not be able to compete successfully with others’ existing or future products.

Reasonable cost management continued development of capacities and technologies, diversification of revenues as well as revenues from valuable, result-driven alliances are critical factors for us in maintaining a significant role in the world of drug discovery in the pharma and biotechnology sector.

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Failure of mergers and acquisitions

We have strategic growth targets which we intend to achieve through a combination of organic growth and the acquisition of complementary service and research capacities. We intend to undertake additional strategic acquisitions; however, doing so may not realize the intended advantages of such acquisitions and investments, if we are unsuccessful in ascertaining or evaluating target businesses. For instance, our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of these transactions. If we fail to realize the expected benefits from acquisitions or investments, whether because of e.g., unidentified risks or liabilities or integration difficulties, our business, results of operations and financial condition could be adversely affected (e.g., impairments on goodwill or intangible assets). Moreover, we may not be able to locate suitable acquisition or partnership opportunities. Following an acquisition, we may not be able to successfully integrate the acquired business or operate the acquired business profitably. In addition, integration efforts often take a significant amount of time, place a significant strain on managerial, operational, and financial resources, might result in the loss of key personnel and can prove to be more difficult or expensive than predicted. The diversion of the management’s attention and any delay or difficulties encountered in connection with any future acquisitions could result in the disruption of our ongoing business or inconsistencies in standards and controls that could negatively affect our operations, including the ability to maintain third-party relationships. If we encounter difficulties integrating newly acquired assets or operations with our platform, our business, and results of operations as a group may be adversely impacted. Moreover, if we invest in new modalities and technologies, it may not be successful in integrating them into our platform offerings or generating customer or partner demand for them, which could result in failure to generate a return on our investment. Some of the businesses we may seek to acquire may be marginally profitable or unprofitable. For these businesses to achieve acceptable levels of profitability, we may need to improve our management, operations, products and/or market penetration. We may not be successful in this regard, and it may encounter other difficulties in integrating acquired businesses into our existing operations. Further, if we undertake acquisitions, it may utilize our cash, issue dilutive securities, assume or incur debt obligations, incur large one-time expenses, and acquire intangible assets that could result in significant future amortization expense. Further, as part of our EVOequity model, from time to time we invest in start-up companies and/or development stage technology. In evaluating these opportunities, we follow an evaluation process that considers factors such as potential financial returns, new expertise in emerging drug discovery and business benefits. Despite our best efforts to calculate potential return and risk, some, or all the companies we invest in may be unprofitable at the time of, and subsequent to, our investment. For example, during the year ended December 31, 2022, we recognized a € 171.3 milion measurement loss, mainly related to the decline in value of our investment in Exscientia plc. We have incurred and may continue to incur losses from these investments, including the potential for future impairment charges on the investments, and the anticipated benefits of the technology and business relationships may be less than expected. We therefore strive to ensure the proper adjustment and smooth integration of the new companies’ technologies, cultures, systems and processes and act as ONE Evotec. Based on the experience of past acquisitions, we make use of all necessary resources and departments to ensure a smooth integration process.

Market risks

Termination of projects and contractual relationships

We depend on certain individual large customers. The loss of any of these customers would have a material adverse impact on our results of operations. Furthermore, certain of our service contracts involve scientific or technical delivery risks. In 2021 and 2022, the revenue contribution of our three largest customers was 25%. Although we generally have long-term contracts with our major customers, there is a risk that customers may terminate projects and contractual relationships earlier than planned for strategic reasons or reasons for which we are responsible. High-quality services, innovative solutions and close interaction with customers are key measures to reduce the likelihood of early contract termination or to identify its risk at an early stage. Nevertheless, the risk cannot be fully controlled due to strategic decisions of our customers that cannot be influenced. If a customer exits a drug discovery and development project, significant future revenues including milestone and royalty payments could be lost.

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Commercial risk from out-licensing and licensed products

We depend in part on out-licensing arrangements for late-stage development, marketing, and commercialization of our pipeline assets. Dependence on out-licensing arrangements subjects us to several risks, including the risk that we have limited control over the amount and timing of resources that our licensees devote to pipeline assets, that our licensees may experience financial difficulties or that our licensees may fail to secure adequate commercial supplies of pipeline assets upon marketing approval. Moreover, we face the risk that our future revenues depend heavily on the efforts of our licensees and that business combinations or significant changes in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete the development, marketing and/or commercialization of the relevant pipeline assets. Finally, a licensee could move forward with a competing product candidate developed either independently or in partnership with others, including our competitors.

If we or any of our licensees breach or terminate their agreements with us if any of our licensees otherwise fail to conduct their development and commercialization activities in a timely manner or if there is a dispute about their obligations, we may need to seek other licensees, or we may have to develop our own internal sales and marketing capability for our pipeline assets. Our dependence on our licensees’ experience and the rights of our licensees could limit our flexibility in considering alternative out-licensing arrangements for our pipeline assets. Any failure to successfully develop these arrangements or failure by our licensees to successfully develop or commercialize any of our pipeline assets in a competitive and timely manner will have a material adverse effect on the commercialization of our pipeline assets.

Competitive situation

The world of drug discovery in the pharmaceutical and biotechnology sector has grown rapidly in recent years. As a result, we are closely monitoring the competitive situation and the competitive environment. Our mission is to discover best and first-in-class medicines for a broad range of difficult-to-treat diseases in collaboration with our partners. To that end, we have built a comprehensive suite of fully integrated, next-generation technology platforms that we believe will transform the way new drugs are discovered. By leveraging the advanced capabilities of our integrated platforms, we can provide solutions to our partners that enable significant improvements in the quality of new drugs while accelerating the drug discovery process and reducing the high cost of attrition often associated with traditional drug discovery processes. The industry in which we operate is highly competitive, with many players pursuing similar scientific approaches. If we do not continually offer our partners innovative and cutting-edge solutions and remain at the forefront of precision medicine, our business may be materially and adversely affected. Moreover, our business operations are subject to challenges because of industry pressures. For instance, we expect the industry to continue experiencing pricing pressures due to the persistent trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs, particularly on prescription drugs, has intensified and our partners are impacted accordingly. As our business is dependent on the continued health and growth of the pharmaceutical and biological industry, should the industry contract due to pricing pressure, our business may be materially and adversely affected.

Risks related to a pandemic

The initial stages of the COVID-19 pandemic were an extraordinary shock for the economies of the EU and the rest of the world and had severe economic and social consequences.

The COVID-19 pandemic has led to the implementation of various containment measures, including government-imposed shelter-in-place orders, quarantines, national or regional lockdowns, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers across the world. Although of the pandemic is entering an endemic phase in many Western countries and the most dangerous waves of infection are presumably over in Europe and North America, China has started a new wave of infection following the end of its “zero COVID” policy at the end of 2022, suggesting that COVID-19 may remain an ongoing global problem and risk. An economic crisis in China as a result of COVID-19 may further exacerbate the inflationary environment in Europe as well as produce supply bottlenecks. It also increases the risk of virus variants and increased infections that can spread beyond China. As a result of the COVID-19 pandemic, we have experienced and may in the future (with COVID-19 or other similar pandemics and outbreaks) experience severe disruptions, including:

interruption of or delays in receiving products and supplies, such as pipettes and pipette tips, from the third parties we rely on to, among other things, provide our service offerings to our customers or manufacture for our customers, which may impair our ability to operate our business.

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limitations on our business operations by local, state, or federal governments that affect our ability to operate our business.
delays in customers’ orders and negotiations with customers and potential customers.
delays in clinical trials conducted by our partners, leading to a decrease in revenue in our EVT Innovate segment due to a corresponding delay in milestone achievements.
business disruptions caused by workplace, laboratory and office closures and an increased reliance on employees working from home, travel limitations, cyber security and data accessibility limits, or communication or mass transit disruptions; and
limitations on employee resources that would otherwise be focused on the conduct of our activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.

Any of these factors could severely affect our operations. We cannot predict the scope and severity of any potential business shutdowns or disruptions because of a newly intensifying COVID-19 pandemic. The extent to which a pandemic may negatively impact our consolidated operations and results of operations or those of our third-party manufacturers, suppliers, partners, or customers will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

Financial risks

Risks of changes in tax laws and interpretations by authorities and R&D tax credit risks

We operate in many different countries and are therefore potentially taxable in several countries and subject to various national tax laws and regulations. Changes in tax laws, jurisdiction and interpretations by authorities or courts as well as findings based on audits by authorities in these countries can lead to additional tax expenses and payments, which can negatively impact our business, our financial position, and results. These unforeseen additional tax expenses can arise for several reasons. Due to the complexity of our business model, this could affect the tax treatment of individualized elements of customer contracts, the taxable presence of a group company in a tax jurisdiction, adjustments to transfer prices, the application of indirect taxes to certain transactions and the non-recognition of the benefits of double tax treaties. Furthermore, R&D tax credits in various countries contribute significantly to our financial performance. Changes can also arise from significant acquisitions, divestments, restructuring and other reorganizations. Due to the global economic downturn caused by the COVID-19 pandemic, the Russia-Ukraine war and the resulting increase in government costs, there is a higher risk that we will receive notifications about the reduction or failure to grant tax relief or receive adverse changes to tax assessments.

Currency risks

We manage currency risks via close, forwards, natural hedges, and other selective hedging instruments. Hedging transactions are entered into for future transactions that can be reliably anticipated based on our order book. Despite active currency management, exchange rate risk cannot be eliminated due to unpredictable volatility. As a result, our business may be affected by fluctuations in foreign exchange rates, which may have a significant impact on our results of operations and cash flows from period to period. Currency exchange movements also impact our reported liquidity in respect of translating liquid assets held in U.S. dollars or pound sterling into Euros. Interest rate risks may arise from inevitable negative interest on investments of available cash after capital increases, financing, etc. The increase in interest rates affects the interest charges on our variable interest-bearing loans and leads to additional interest expenses. Additionally, we regularly maintain cash balances at third-party financial institutions in excess of applicable insurance limits and are therefore reliant on banks and other financial institutions to safeguard and allow ready access to the assets. If banks or financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened.

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Liquidity risk

Revenue fluctuations, expenditures, external events, and changes in the business environment might negatively impact our short-to-medium-term profitability and liquidity. As of December 31, 2022, we had €718.5 million in cash, cash equivalents and investments. However, our operating plan may change because of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, sales of assets, marketing and distribution arrangements, other partnerships and licensing arrangements, or a combination of these approaches. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. Our spending will vary based on new and ongoing development and corporate activities. At the end of 2022 Evotec was able to secure € 150 million in additional financing from the EIB. Overall, we believe, we have sufficient liquidity to meet liabilities when due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to our reputation. Our business and reported profitability are affected by fluctuations in foreign exchange rates mainly between the US dollar, Pound Sterling, and the Euro.

Legal/compliance risks

Quality risks in R&D

The success of our business hinges upon the fulfillment of both our own and legal quality standards. Parts of our operations are subject to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (“GCP”) requirements and similar requirements. Regulatory authorities and our customers may conduct scheduled or unscheduled (for cause) periodic inspections of our facilities to monitor our quality control system and verify that we comply with regulatory requirements and with the terms of our quality agreements with our customers. Audit findings that are classified as “critical” may lead to a loss of certification with regulatory agencies or a loss of approved supplier status with our customers and a subsequent loss in revenue. Our manufacturing facilities also require certification and validation activities to demonstrate that they operate as designed. In addition, our manufacturing facilities are subject to regulatory inspections by the FDA, the national competent authorities in EU member states (including AIFA in Italy), the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the United Kingdom, and other comparable regulatory authorities. If we are unable to reliably manufacture products in accordance with the legal and regulatory requirements of the relevant regulatory authorities, we may not obtain or maintain the necessary approvals. Further, our facilities may fail to pass regulatory inspections, which would cause significant delays and additional costs required to remediate any deficiencies identified by the regulatory authorities. In addition, any failure of quality in the product could cause significant delays and additional costs required to remediate any deficiencies. Any failure in quality which can cause damage to the patient may be subject to civil and criminal penalties. Any of these challenges could delay the completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay regulatory approval, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, damage to reputation, financial condition, results of operations and growth prospects.

General Governance and compliance risks (fraud, corporate governance)

Risks of failing to maintain effective internal control over financial reporting as a U.S.-listed company.

We have identified material weaknesses in our internal control over financial reporting as of December 31, 2022. We are subject to requirements under the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”), to perform system and process evaluation and testing of our internal control over financial reporting to allow management to assess the effectiveness of our internal controls. Management has identified certain material weaknesses in our internal control over financial reporting. As a result, management has concluded that, as of December 31, 2022, our internal control over financial reporting was not effective, as more fully described in Item 15.E of this annual report. Management has also accordingly concluded that our disclosure controls and procedures were not effective.

The material weaknesses that have been identified relate to the failure to design and maintain an effective risk assessment process to identify and analyze the risk of material misstatements in its financial statements and the failure to design and maintain effective internal controls as a lack of sufficient accounting and supervisory personnel who have the appropriate level of technical accounting experience and training and a lack of consistent application of accounting processes and procedures.

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Notwithstanding these material weaknesses, we confirm that our consolidated financial statements, as included in this annual report, fairly present, in all material respects, our consolidated financial condition as of December 31, 2022 and 2021, and our consolidated results of operations and cash flows for the years ended December 31, 2022, 2021 and 2020, in conformity with IFRS. Management has developed a remediation plan to address the material weaknesses, including enhancing the risk and control frameworks, which will build on the significant attention that management has devoted to controls to date. While we are taking steps to address these material weaknesses, which could require us to expend significant resources to correct the material weaknesses or deficiencies, any gaps or deficiencies in our internal control over financing reporting may result in us being unable to provide required financial information in a timely and reliable manner and/or incorrectly reporting financial information, which could reduce confidence in our published information, impact access to capital markets, impact the trading price of our securities or subject us to potential regulatory investigations and sanctions. In addition, there can be no assurance that these measures will remediate the material weaknesses in our internal control over financial reporting or that additional material weaknesses in our internal control over financial reporting will not be identified in the future. Any of the foregoing could materially and adversely affect our business, results of operations and financial condition.

Litigation and contractual risks

We are exposed to risks from litigation and legislation. As a result, we are exposed to the potential risk that legal action, court rulings or out-of-court settlements may have adverse financial consequences. We are bound by numerous complex contracts with a low degree of standardization, in particular customer contracts. Contractual clauses that are flawed, contentious, or unfavorable for us may entail contractual risks like legal liability risks and financial risks. We and our pharmaceutical and biotechnology customers and partners are subject to extensive regulations by the EMA, the FDA and similar regulatory authorities in other countries for the development, manufacturing, and commercializing of products for therapeutic or diagnostic use. Such regulations include but are not limited to, restrictions on testing on animals and humans, manufacturing, safety, efficacy, labeling, sale, advertising promotion and distribution of our or our partners’ products.

Regulatory risks

New laws and regulations to that we, our customers, our and partners are subject to may change in the future affecting the viability of market entry for new products developed in our EVT Innovate segment or the ability to continue certain projects in the EVT Execute segment that may consequently be terminated at an early stage.

Product liability risks

It is possible that we will be responsible for potential product liability stemming from product research, development or manufacturing and may face an even greater risk if any drug candidate that we develop is commercialized. If we cannot successfully defend ourselves against claims that drug products we develop with our partners caused injuries, we could incur substantial liabilities. Regardless of the merit or eventual outcome of such claims, any liability claims may result in e.g., decreased demand for any drug product that we may develop with our partner, loss of revenues, significant time and costs to defend the related litigation, initiation of investigations by regulators and injury to our reputation and significant negative media attention. We are covered by liability insurance, but notwithstanding such coverage, our financial position or results could be negatively affected by product liability claims. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects.

Ownership and patent risks

If our business activities conflict with patents or other intellectual property rights of third parties, activities may be suspended or there may be a legal dispute. Also, if we believe that its patents or other intellectual property rights have been infringed upon by a third party, we might file lawsuits. These actions could have an influence on our financial position or results.

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Uncertain protection for Evotec´s intellectual property

Our success depends in part on our ability to develop, use and protect our proprietary methodologies, software, compositions, processes, procedures, systems, technologies, and other intellectual property. To protect our intellectual property position, we primarily rely upon trade secrets, confidentiality agreements and policies, invention assignments and other contractual arrangements, trademark registrations and copyrights. Although our patent portfolio is not material to certain of our business as a whole, we have filed patent applications in the United States, Europe and abroad related to our pipeline assets, processes, or other technologies (including methods of manufacture). Our collaboration partners also file patent applications on their development assets on which we may earn milestones and royalties. We may not be able to apply for patents on certain aspects of our current or future pipeline assets, processes or other technologies and their uses in a timely fashion or at a reasonable cost. Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings before various patent offices or in courts in the United States, Europe, or other jurisdictions. The degree of future protection for our intellectual property and other proprietary rights is uncertain. Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Additionally, our intellectual property may not provide us with sufficient rights to exclude others from copying our processes and technologies or commercializing pipeline assets. If we do not adequately obtain, maintain, protect, defend and/or enforce our intellectual property and proprietary technology, competitors may be able to use our proprietary technologies and erode or negate any competitive advantage we may have, which could have a material adverse effect on our financial condition and results of operations.

Risks in a patent prosecution process

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our current or future licensors or partners will be successful in prosecuting, obtaining, protecting, maintaining, enforcing and/or defending patents and patent applications necessary or useful to protect our proprietary technologies (including pipeline assets and methods of manufacture) and their uses. Furthermore, the patent prosecution process is also expensive and time-consuming, and we may not be able to file, prosecute, maintain, protect, defend, enforce, or license all necessary or desirable patents or patent applications, as applicable, at a reasonable cost or in a timely manner or in all potentially relevant jurisdictions.

Risks in case of changing patent laws

The patent position of pharmaceutical and biotechnology companies is generally highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. Moreover, there are periodic changes in patent law, as well as discussions in the Congress of the United States and in international jurisdictions about modifying various aspects of patent law and such changes in patent laws or in interpretations of patent laws may diminish the value of our intellectual property. There is no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.

Risks in detecting infringement, misappropriation and other violation.

Our ability to enforce our owned (solely or jointly), and in-licensed patent and other intellectual property rights depends on our ability to detect infringement, misappropriation and other violation of such patents and other intellectual property. It may be difficult to detect infringers, misappropriators and other violators who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement, misappropriation or other violation in a competitor’s or potential competitor’s product or service, and in some cases, we may not be able to introduce obtained evidence into a proceeding or otherwise utilize it to successfully demonstrate infringement. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded if we were to prevail may not be commercially meaningful. If any of our owned (solely or jointly) or in-licensed patents covering our pipeline assets, processes or other technologies are narrowed, invalidated, or found unenforceable, or if a court found that valid, enforceable patents held by third parties covered one or more of our pipeline assets, processes or other technologies, our competitive position could be harmed or we could be required to incur significant expenses to protect, enforce or defend our rights.

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Risks in securing licenses.

We currently have rights to certain intellectual property, through our owned (solely or jointly) and in-licensed patents and other intellectual property rights relating to the identification and development of our pipeline assets, processes, or other technologies. Our pipeline assets, processes or other technologies could require the use of intellectual property and other proprietary rights held by third parties and their success could depend in part on our ability to acquire, in-license or use such intellectual property and proprietary rights. In addition, our pipeline assets may require specific formulations to work effectively and efficiently, and these intellectual property and other proprietary rights may be held by others. We may be unable to secure such licenses or otherwise acquire or in-license from third parties any compositions, methods of use, processes, or other third-party intellectual property rights that we identify as necessary or consider attractive, on reasonable terms, or at all, for pipeline assets, processes, and other technologies that we may develop. The licensing and acquisition of third-party intellectual property rights is a competitive area, and several more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we, or our partners, may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

Third-party challenge to Evotec’s or Evotec’s licensors’ patents

Our owned (solely or jointly) and licensed patents and patent applications may be subject to validity, enforceability, and priority disputes. The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Some of our patents or patent applications (including licensed patents and patent applications) may be challenged at a future point in time in opposition, derivation, re-examination, inter partes review, post-grant review or interference or other similar proceedings. Any successful third-party challenge to our or our licensors’ patents in this or any other proceeding could result in the unenforceability or invalidity of such patents, which may lead to increased competition to our business, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks from unknowing all third-party intellectual property rights

We may not be aware of all third-party intellectual property rights potentially relating to our assets. Publications of discoveries in the scientific literature often lag the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the United States Patent and Trademark Office (USPTO), or other similar proceedings in non-U.S. jurisdictions (e.g., within the jurisdiction of the “Deutsches Patent und Markenamt” DPMA or European Patent Office EPO), that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of such proceedings and regardless of whether we are successful, we could experience significant costs and our management may be distracted. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations and prospects.

Future litigation by third parties

Our commercial success depends in part on our ability and the ability of future partners to develop, manufacture, market and sell our assets and use our assets and technologies without infringing, misappropriating, or otherwise violating the intellectual property rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology industry, as well as administrative proceedings for challenging patents, including interference, derivation, inter partes review, post-grant review, and re-examination proceedings before the USPTO, or oppositions and other comparable proceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our assets, manufacturing methods, software and/or technologies infringe, misappropriate, or otherwise violate their intellectual property rights.

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Limited lifespan of patents

Most international jurisdictions provide a 20-year nominal patent term, though many require payment of regular, often annual, annuities to maintain pendency of an application or viability of an issued patent. In some jurisdictions, one or more options for extension of a patent term may be available, but even with such extensions, the lifespan of a patent, and the protection it affords, is limited. Even if patents covering our or our partners’ assets, processes and other technologies and their uses are obtained, once the patent term has expired, we may be subject to competition from third parties that can then use the inventions included in such patents to create competing products and technologies. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

HR risks

Loss of highly qualified staff (key employees)

The loss of any of our key employees could impede the achievement of our short-term financial targets as well as our medium- and long-term strategic goals. Our ability to compete in the highly competitive biotechnology and pharmaceutical industry depends upon our ability to identify, attract, develop, motivate, adequately compensate, and retain highly qualified managerial and scientific personnel. We are highly dependent upon members of our management and qualified scientific personnel to perform R&D work and therefore are exposed to the risk that losing employees may mean the loss of critical knowledge. We may not be able to retain these employees due to the competitive environment in the biotechnology industry. The loss of any of our employees’ services may adversely impact the achievement of our strategic objectives. We currently do not have “key person” insurance on any of our employees. We also may encounter problems hiring and retaining the experienced scientific, quality-control and manufacturing personnel needed to operate our manufacturing processes and operations, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements. To reduce this risk, we have established defined documentation processes, shared knowledge platforms, lab journals, clearly defined job functions and project meetings to secure some of the relevant knowledge, findings, and data. At the same time, long-term incentive (LTI) awards for senior employees serve as a long-term retention measure. For reasons of risk mitigation and business strategy, we have set up our organization such that key employees develop a common level of knowledge, with well-defined rules of substitution and succession. Evotec also strives to reduce its employee attrition in general throughout the company thanks to a combination of measures in compensation and benefits packages, career development and leadership development initiatives.

Information technology risks

Cyber risks, data integrity and protection and loss of data

We collect and maintain information in digital form that is necessary to conduct our business, particularly for purposes of our PanOmics, PanHunter, J.DESIGN and induced Pluripotent Stem Cell (iPSC)-based drug discovery platforms, and we are highly dependent on our information technology systems. In the ordinary course of our business, we collect, store, and transmit large amounts of confidential information, including intellectual property, proprietary business information, human samples and personal information. We have also outsourced elements of our information technology infrastructure, including our internal computer system, and as a result, several third-party vendors may or could have access to confidential information.

Our information technology systems, including our internal computer systems, and data have been, and may continue to be, vulnerable. As previously disclosed, on April 6, 2023, we were the victim of a ransomware incident that has continued to impact our operations. Upon learning of the incident, we immediately retained a team of third-party forensic, incident response and security professionals and engaged external counsel to respond to and contain, as well as to investigate and determine the full scope of, the incident. We also notified law enforcement officials and confirmed that we have certain insurance coverage for such incidents. However, there is no guarantee that we will be fully reimbursed for all expenses incurred in connection with the incident. The incident has caused, and may continue to cause, delays in our operations and result in a deferral or loss of revenue and incurrence of incremental costs that may adversely impact our results of operations, cash flows and financial condition and the trading price of our Common Stock.

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As a result of the ransomware incident and any future cyber security incidents, information stored on our networks may be manipulated, publicly disclosed and permanently lost. Any such breach or other loss of information could result in legal claims or proceedings and liability under laws that protect the privacy of personal information, as well as regulatory penalties. We cannot guarantee that third parties will not be able to gain unauthorized access to or otherwise breach our systems in the future. Any such unauthorized access or breach could adversely affect our business, results of operations and financial condition.

There is no assurance that there will not be cyber security incidents or vulnerabilities that will have a material adverse effect on us in the future.

GDPR and other similar jurisdictions

Considering the significantly expanded regulations under General Data Protection Regulation (GDPR) and other similar jurisdictions, we are permanently reviewing the handling of relevant internal and external data and our respective flow, storage, and access. If we fail to comply with the GDPR and the applicable national data protection laws of the European Union member states, or if regulators assert, we have failed to comply with these laws, it may lead to regulatory enforcement actions or other administrative penalties. This may be onerous, may interrupt, or delay our development activities, and may adversely affect our business, financial condition, and results of operations. We must comply with the GDPR and the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains GDPR in the United Kingdom’s national law. The European Commission has adopted an adequacy decision which will automatically expire on June 27, 2025, unless the European Commission re-assesses and renews/extends that decision. The relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law therefore remains unclear, and it is unclear how the United Kingdom data protection laws and regulations will develop in the medium-to-longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. These changes may lead to additional costs and increase our overall risk exposure. Other jurisdictions outside the European Union are similarly introducing new or enhancing existing privacy and data security laws, rules, and regulations, which could increase our compliance costs and the risks associated with non-compliance. Privacy and data security laws are rapidly evolving, and the future interpretation of those laws is somewhat uncertain. We cannot guarantee that it is, or will be, in compliance with all applicable international regulations as they are enforced now or as they evolve. There is significant uncertainty related to the way data protection authorities will seek to enforce compliance with privacy and data security laws, including the GDPR. Enforcement uncertainty and the costs associated with ensuring compliance with privacy and data security laws, including the GDPR may be onerous and adversely affect our business, financial condition, results of operations and prospects. If any of these events were to occur, our business and financial results could be significantly disrupted and adversely affected. In this regard, we have intensified our employee training efforts to increase awareness of the need to review and adjust internal data protection procedures and improve restricted access applications. In addition, we have defined routines and installed internal and external contact persons in the event of certain potential types of data breaches.

Operational risks

Procurement risks

Our business depends on a reliable supply of various materials for our laboratories and production. Due to our business model, short-term order inquiries are unavoidable, such that delivery bottlenecks can lead to delays in projects and production and thus have a negative impact on our capacity planning and earnings situation. Price increases for laboratory and production materials, but also for electricity and gas, represent a financial risk for us. We face this risk by working closely with our suppliers and using different sources of supply. Due to regulatory requirements, however, we are not always able to switch to other sources of supply, so it cannot fully mitigate the risk. We try to limit the risk by reviewing and monitoring our supplier relationships, a continuous exchange with the operational areas for the early identification of needs and constant market analyses. In the context of the Russia/Ukraine conflict we are facing high procurement risks in the short term due to increasing electricity and gas prices for entities purchasing gas and electricity on the Spot market. In the event of a short-to-medium-term gas shortage, it may result in interruptions such as a production stop in Evotec’s sites if Evotec is unable to switch sufficiently to alternative sources of supply. Such a gas shortage could also have a direct impact on Evotec’s suppliers and could disrupt the entire supply chain. We also see a risk of increasing transportation costs due to higher transport times and on the charging of energy costs from our suppliers.

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Process risks

We recognize the importance of balanced knowledge management, for example in the context of external reporting deadlines or adequate runtimes of processes. Due to our steady growth, we must continuously adjust our organizational and functional management as well as standards, business processes and structures in accordance with our current and future scale. For example, our global finance function has initiated organizational improvement measures and additional change management measures to avoid knowledge monopolies and make the finance organization more robust and flexible. This is also meant to prevent process risks such as inefficiencies and ensure accurate and high-quality financial data.

Major disasters on sites

In the event of a direct or secondary disaster that results in stoppages of our activities on one or multiple sites, or in damages and/or interruptions to the operations of key suppliers, we may be forced to suspend or incur significant delays in parts or all our activities. In each case, there is a potential risk that our financial position and operating results may be substantially affected. We therefore rate this risk as high from a financial standpoint. In addition, the implementation of R&D plans may be impacted by damages to our research facilities as well as medical and other institutions at which testing is conducted. In case of major disasters such as extreme weather events, earthquakes (especially in risk areas like Seattle, United States), or plane crashes, we may suffer loss of business due to an inability to execute contracts and fulfill client deliverables. We have created business continuity plans as well as disaster recovery plans and have insurance for these rare events.

Environmental, health and occupational safety risks

We continuously enhance our operational risk management and optimize the accountability and performance assessment mechanism of all departments and functions. We actively gather data on operational risk to enable proactive risk prevention opportunities. The long-term objective is to monitor the level of operational risk across the Group monthly to gain insights preventively, thereby reducing our operational risks and saving costs in the long term. The nature of our operating activities exposes Evotec to a wide range of health, safety, and environmental risks. Our EHS teams and management systems help identify these risks and drive performance improvements by setting and advising on industry standards and compliance requirements by minimizing the complexity of such standards and requirements. Looking forward we are building governance and competence in the EHS function as we look to establish a deeper focus on proactive risk management, aligned with the global trends, and emphasize ongoing compliance developments and client expectations in this space.

Item 4.                 Information on the Company

A.History and Development of the Company

We were incorporated on December 8, 1993, as a company with limited liability (Gesellschaft mit beschränkter Haftung) under the laws of Germany under the name EVOTEC BioSystems GmbH, formerly registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Hamburg, Germany, under the number HRB 54731. On August 7, 1998, we were converted into a German stock corporation (Aktiengesellschaft) under the laws of Germany under the name EVOTEC BioSystems Aktiengesellschaft, formerly registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Hamburg, Germany, under the number HRB 68223. On February 28, 2002, we changed our name to Evotec OAI AG, and on June 8, 2005, we changed our name to Evotec AG. On March 29, 2019, we converted into a European stock corporation (Societas Europaea, or SE) under the laws of Germany and the European Union called Evotec SE, registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Hamburg, Germany, under the number HRB 156381.

Since November 10, 1999, we have been listed on the regulated market of the Frankfurt Stock Exchange under the trading symbol “EVT” and under the ISIN DE0005664809. Our shares are currently listed under the Segment Prime Standard. As a result of the cyber attack, a delay in external reporting occurred, which has led to a likely temporary exclusion from the indices of the Frankfurt Stock Exchange. Evotec expects to rejoin the relevant indices after the next regular review of admission requirements by Deutsche Börse.

On November 3, 2021, our registration statement on Form F-1 (File No. 333-260143), as amended, was declared effective by the SEC for our initial public offering of our ADSs, each representing one-half of one ordinary share, no par value per share, pursuant to which we offered and sold a total of 22,995,000 of our ADSs, at a public offering price of $21.75 per share.

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As previously disclosed, on April 6, 2023 we were the victim of a ransomware incident that has continued to impact our operations. Upon learning of the incident, we immediately retained a team of third-party forensic, incident response, and security professionals and engaged external counsel to respond to and contain, as well as investigate and determine the full scope of, this incident. We also notified law enforcement officials and confirmed that we have certain insurance coverage for such incidents.  

As a result of the incident, certain of our data was encrypted so that we could not access it, some of our data was exfiltrated from our systems, and business activities at several of our facilities were temporarily disrupted. As of the date hereof, we are able to decrypt the data that was encrypted and are confident to gain full access to all our data. We are still conducting an investigation of the incident with assistance from our outside professionals. Preliminary findings indicate that the unauthorized third-party gained access to certain personal employee information as well as certain customer-related data. There is currently no indication of any misuse of this information. Preliminary findings also indicate that the incident has been contained. We are recovering the impacted data, and we are not currently aware of any evidence of the impacted data being publicly released. We continue to investigate what information may have been accessed or exfiltrated and resolve open items related to the incident. Despite this disruption, we continued our business. Working alongside our security professionals, we are planning to bring our systems back online with enhanced security controls in due course. Due to the recency of the event, we are unable to evaluate the associated expenses yet.

However, we intend to make additional investments in the future to further strengthen our cyber security. We remain committed to protecting the security of the personal information entrusted to us and providing high-quality products and services to our customers. We are actively managing the incident and will continue to do so.  We remain committed to protecting the security of the personal information entrusted to us and providing high-quality services to our customers.

Our principal executive offices are located at Essener Bogen 7, Hamburg, Germany. Our telephone number is +49 40 560 81-0. Our website address is http://www.evotec.com. The information contained on, or that can be accessed through, our website is not incorporated by reference into this annual report. We have included our website address as an inactive textual reference only.

Our agent for service of process in the United States is Evotec (US) Inc., 303B College Road East Princeton, NJ 08540 Tel: (732) 329-2355.

B.Business Overview

We are an industry-leading drug discovery and development partner for the pharmaceutical and biotechnology industry. Our mission is to discover, develop and manufacture medicines that matter for a broad range of difficult-to-treat diseases in highly efficient collaborations with our partners. We focus 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.

We built a “shared economy” business-to-business model in R&D, designed to result in efficient collaborations to discover in collaboration with our partners best and first-in-class medicines while participating in the success of drug candidates through the creation of a royalty pool. Our 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 our partners, we dedicate our 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, we have 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, we provide solutions to our partners, which we believe will transform the way new drugs are discovered and which enable significant improvements in the quality of new drugs. The aim is to provide better access in many underserved areaswhile accelerating the drug discovery and development process and reducing the high failure rates that are still observable in the industry today.

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Traditional drug discovery and development is a lengthy, costly, and complex process that is subject to a high degree of uncertainty and high failure rates. In addition, identifying novel compounds requires extensive screening and in vitro and in vivo testing, which can be both labor-intensive and time-consuming. In most R&D models today, for every successful medicine that is commercialized, 5,000 to 10,000 compounds fail in drug discovery. Moreover, it takes approximately 12 years of intense R&D, and approximately $ 2 billion for a new medicine to reach patients.

Our 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. We collaborate with our partners in all early research phases from sourcing novel ideas to early clinical development. Our platforms specifically designed for precision drug development and to lead to differentiated results by integration into established R&D capabilities that are leveraged by our experienced scientists. Our 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.

For the near future, a substantial majority of revenues generated from the offerings to our partners will be based on “fee-for-service” agreements or FTE-based arrangements, recognized in one of our reporting segments, EVT Execute. Subject to the degree of integration of proprietary technologies, or if alliances are built based on in-house R&D projects as part of EVT Innovate, we may also benefit from milestone, license, and royalty payments in addition to the compensation via FTE rates. In the years ended December 31, 2021, and 2022, 8.1% and 2.7%, respectively, of our total group revenues from third parties were derived from milestone, license, and royalty payments.

In 2022, we expanded our network of manufacturing facilities to five. We have the capacity for continuous manufacturing of biologics is in the United States, in Redmond (Washington). Our API (Active Pharmaceutical Ingredient) manufacturing capabilities are in Europe in Abingdon, United Kingdom and Verona, Italy as well as in Halle/Westphalia in Germany after the closing of the acquisition of Central Glass in November 2022, which now operates under the name of Evotec Drug Substance (Germany) GmbH (Evotec DS). In May 2022, we announced the acquisition of Rigenerand, now operating as Evotec (Modena) Srl., adding GMP manufacturing capabilities for cell and gene therapy. We now have the capability to manufacture drug products across all relevant modalities to support the clinical development and commercialization of both our own and our partners’ assets.

With close to 5,000 employees, we leverage our technologies and platforms to develop medicines that matter across multiple modalities, with the aim of ultimately making the right drug available to the right patient. Our drug candidates can be created at as low as half the cost of current benchmarks for discovery through Investigational New Drug (IND) applications and those currently 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 our 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 our 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.

We report the results of our work and collaborations through two operating segments:

EVT Execute: primarily includes fee-for-service and FTE-rate-based arrangements where our customers own the intellectual property. EVT Execute accounted for 73% of our revenues from third parties in the year ended December 31, 2022, and 76% and 79% for the years ended December 31, 2021, and 2020, respectively.
EVT Innovate: includes our internal R&D activities as well as services and partnerships that originate from these R&D activities. In addition to FTE-based revenues, we generate revenues from milestones and royalties on our pipeline assets. EVT Innovate accounted for 27% of our revenues from third parties in the twelve months ended December 31, 2022, and 24% and 21% for the years ended December 31, 2021, and 2020, respectively.

We leverage our offerings described throughout this annual report across both EVT Execute and EVT Innovate. Revenue generated through our collaboration arrangements based on our four focus areas PanOmics, iPSC, Just – Evotec Biologics and End-to-End Shared R&D. These areas may contribute to either the EVT Execute segment or the EVT Innovate segment, depending on the nature of the contract with our customer, the ownership of the intellectual property, the stage of the project and our right to generate revenue from development success. We believe our partnership model is unique and allows us to balance and diversify the risks associated with drug discovery.

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Focus areas: PanOmics, iPSC-based “off-the-shelf” cell therapies based on induced-pluripotent stem cells, Just – Evotec Biologics and End-to-End Shared R&D

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1 Sponsoring and execution of clinical trials as well as distribution and marketing iare under the responsibility of partners, still sharing upside in case of success.

1.PanOmics-driven drug discovery for deep disease understanding and effective therapies.

Recent scientific and technological advancements have significantly eased approaches towards the understanding of diseases at a molecular level, either by investigating the entire complement of a specific type of biomolecule or the totality of a molecular process or signaling cascades within an organism. Working toward the vision of deep human disease understanding and designing highly effective therapies, Evotec leverages several -omics fields and cross-omics insight generation, referred to as PanOmics.

Examples of well-established fields include genomics, transcriptomics, proteomics, and metabolomics. Evotec’s PanOmics platform generates genomics, transcriptomics, proteomics, and metabolomics data of the highest quality on an industrial scale to profile and selects promising new drug candidates derived from comprehensive cell biological profiles from molecular patient databases – Evotec’s Molecular Patient Databases (E.MPD).

The results often lead to the stratification of sub-populations within a broader group of patients and eventually may lead to the development of personalized therapies. This change in paradigm has increased the need for new AI/ML-based platforms, tools, and methods to better understand, interpret, and translate the vast amounts of information and data that is being generated to better understand the molecular biology, cell regulation and the pathogenesis of individual diseases. PanHunter, Evotec’s integrated data analytics platform, makes the Company’s -omics data available in a user-friendly manner at the enterprise level. Users can freely interact with and combine data in a modular, app-based system where results are available immediately and can be interpreted or used as input for subsequent steps. This rapid feedback is a crucial feature distinguishing PanHunter from other similar tools.

The improved understanding of sub-populations’ disease profiles has resulted in the need for better patient-specific disease modeling. Our AI/ML and precision medicine platforms are therefore complemented by our high-volume/high-quality and proprietary iPSC technology platform, which utilizes patient-derived cell-based assays for disease modeling. iPSC cell assays are crucial to accurately modeling diseases based on the use of human tissue and represent therefore an alternative to animal models to profile drug candidates in the pre-clinical stage.

Moreover, the analysis of disease signatures and individual patient signatures improves patient stratification, driven by biomarker identification (EVOgnostic) as well as human in vitro model-based safety prediction (E.SAFETY).

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Molecular disease understanding for lower attrition / higher Probability of Success (“PoS”)

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2.“Off-the-shelf” cell therapies based on induced-pluripotent stem cells.

iPSC are also the basis for next-generation allogeneic cell-based medicines. Our cell therapy platform leverages our proprietary iPSC technology for this purpose. Here we focus on developing off-the-shelf cell therapies with long-lasting efficacy like immune cells in oncology (e.g., NK cells, T cells and others), beta cells for diabetes, cardiomyocytes in heart repair, and retina cells in ophthalmology as well as iPSC-derived exosomes. Our lead cell therapy candidate is a cell replacement therapy for type 1 diabetes that is currently in preclinical development. A first collaboration in immuno-oncology was signed with an undisclosed partner, while in 2022 the foundation was laid together with the university hospital in Hamburg (UKE) for the development of a next-generation regenerative therapy for patients recovering from a heart attack.

Somatic cells from a healthy donor can be used to produce induced-pluripotent stem cells (iPSCs). These cells can be amplified indefinitely and can then be differentiated into many different human cell types. This platform is therefore ideally suited to manufacture iPSC-derived cell therapeutics at large scale to treat and potentially address a whole plethora of different diseases.

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1) Each cell type can deliver multiple differentiated products

3.

Just – Evotec Biologics: AI and continuous manufacturing for a more cost-efficient access to antibodies.

In the field of biologics discovery, development, and manufacturing, we apply our machine learning and integrated technology platform J.DESIGN to bring further value to our partnerships by designing, developing, and manufacturing biologics in a cost-effective and efficient manner. Because we utilize J.DESIGN throughout the entire drug discovery and development process of a biologic, by the time it reaches the manufacturing stage in any given program, we have already predicted and reduced the risk of most scaling problems that may occur. As a result, we can deliver flexible, right-sized manufacturing with faster turnaround times and without sacrificing the quality of the products. This new paradigm broadens the scope of disease areas for biologic drug candidates driven by significantly higher yields and lower costs. It will also accelerate the growth of biosimilars given cost advantages and it makes orphan diseases more amenable to biologics despite small addressable populations. For the same reasons, smaller patient populations resulting from precision medicine-based patient stratification will also benefit.

To enhance our manufacturing capabilities further, in August 2021, we opened our first J.POD, a late-stage clinical and commercial manufacturing facility that uses single-use technology located in Redmond,Washington, United States. Because our facility contains clinical and commercial processes, both can be operated at the same scale to facilitate seamless transfer and eliminate scale-up risk. The building is approximately 130,000 square feet in size and will house more than 200 employees at full capacity. The site, which will be able to produce on a large enough scale to meet most of our commercial needs in a single facility and will mainly supply markets in North America.

As global demand for flexible biologics capacity and for more affordable access to medicines increases, we have started construction of a second J.POD facility in Toulouse, France in September 2022. Europe is the second largest biologics market and lessons learned from the COVID-19 pandemic led to increasing demand for local capacity and security of supply to improve pandemic preparedness in case needed. The decision to set up this infrastructure at our own site in Toulouse, France was strategic, as the Toulouse footprint creates operational efficiency and co-location with oncology and immunology expertise, adding further synergy with our strategic needs. The second J.POD is expected to be completed by 2024.

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4.End-to-End Shared R&D: an integrated business-to-business platform for increased probabilities of success from target to the patient.

Our 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. We believe that we differentiate from our competition because we combine multimodality expertise, disease expertise and interdisciplinary integration (e.g., molecular design, chemistry, biology, pharmacology, Adsorption, Distribution, Metabolism, Excretion (“ADME”), toxicology, formulation development, API manufacturing, etc.) across the various stages of discovery and development. Highly qualified and experienced scientists lead and coordinate across these processes. Furthermore, the application of AI/ML and model-building capabilities to predictive science aims at improving discovery projects in terms of probability of success, speed, cost, and quality.

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Our sources of revenue generation vary on the types of contracts we have with our partners. Although contracts vary, often times they are linked to intellectual property (“IP”):

In collaborations where ownership of IP resides with one of our partners, we provide stand-alone or fully-integrated drug discovery and development solutions to our partners. Our solutions range across most modalities and from early target identification to the manufacturing of compounds and commercial products. Well-defined work packages are typically provided and compensated on a “fee-for-service”, basis and they are distinct in scope and nature. Typical examples of such services include, among others, high-throughput screening campaigns, Adsorption, Distribution, Metabolism, Excretion and Toxicity tests (“ADME-tox tests”) and Active Pharmaceutical Ingredients (“API”) manufacturing. In addition, fully integrated drug discovery projects, in which partners work with Evotec to conduct interdisciplinary research in pursuit of novel therapeutics, usually under multi-year contracts, are typically compensated on an FTE-basis. These models apply if no intellectual property is involved, or none of our essential proprietary technology platforms are used. The partners’ intellectual property rights therefore protect the resulting therapeutics.

We leverage our 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. These collaborations enable the sharing of cost and risk as our partners typically absorb the costs of clinical development and commercialization.

We also leverage ownership of IP, by making equity investments in products, technology platforms and companies through which we obtain early access to innovation. We facilitate the acceleration of innovation by providing capital as well as access to our technology platforms, expertise, and network. We see significant potential for value creation from these new partnershipsWe expect to realize returns on investments both from successful exits from its portfolio companies (e.g., trade sale, M&A or IPO) and fee-for-service and FTE-rate-based revenues from our portfolio companies. As of December 31, 2022, we had 33 equity engagements with over 120 active projects in our pipelines.

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Value creation pillars of business-to-business model in Biotech

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1 Reaching from out-licensing of own IP to joint creation of IP.

We have experienced significant growth in the recent past. From 2021 to 2022, our revenues increased by €133.4 million, or 22%, from €618.0 million in 2021 to €751.4 million in 2022. Our growth is underpinned by a stable customer base of 819 in 2022 as compared to 842 in 2021. We have maintained a repeat business percentage of 92% (2021: 91%), which we believe affirms the quality of our services and evidences high customer satisfaction. Revenues with our top 10 customers contributed 39% of total revenues in 2022 as compared to 42% in 2021. To facilitate future growth, we intend to expand our investments into proprietary “unpartnered” R&D, which drives the development of our pipeline. From 2021 to 2022 our unpartnered R&D expenses increased by €11.8 million, or 21%, from €58.1 million to €70.2 million. Because of such investments, our number of partnered pipeline assets increased to more than 130, while the pool of yet unpartnered programs exceeds 60 assets, Equity participation increased to 33 as of December 31, 2022.

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Broad pipeline of development

Since 2015, the number of our pipeline assets has more than doubled to over 130 with 18 assets in clinical development as of December 31, 2022. Of the pipeline assets, one obtained market approval in South Korea in 2022, one is in Phase III, four are in Phase II, one is in Phase I/II and eleven are in Phase I.

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We initially developed most of the candidates for which we have the right to receive royalty or milestone payments. We 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 our partners and that have become the subject of a joint research project pursuant to which we are eligible for royalty or milestone payments. We also disclose candidates that are being developed by partners in whom we have solely an equity stake and no right to milestone or royalty payments with respect to their candidates in development but where we could benefit from value accretion related to the progress of these assets.

Beyond therapeutic areas, we have also successfully expanded our pipeline across multiple modalities. In 2015, our 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. We expect the relative share of pipeline-related revenues as a percentage of total revenue to increase as the Company’s pipeline matures and as the revenue mix within all focus areas increasingly includes success-based components, too.

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Our Competitive Strengths

Based on many technological advances and new biological insights, the opportunity to change the odds and improve the success rates in drug discovery has been made more achievable. In our view, our set-up as a fully integrated drug discovery and development innovation hub makes us well-positioned to achieve superior results. We believe we have built the most agile platform in the industry, and we distinguish ourselves from our competition through our competitive strengths, as described below:

Our fully integrated innovation platform has comprehensive breadth and depth: Our platform covers the full discovery, pre-clinical and early clinical development value chain, delivered in a highly integrated, cross-functional manner. This platform is comprehensive and in its breadth and depth provides unique offering that resonates strongly with our partners because we offer a unique combination of disease area expertise, full-suite technology, and predictive power across most modalities. Our competitors in the market for external drug discovery offer services or solutions with a limited scope focusing on discrete steps within the value chain. In contrast, our platform integrates disruptive, proprietary technologies within a holistic product suite to enable the development of potentially first and best-in-class therapeutics. Based on our industry knowledge and the public disclosure of other industry participants, we believe that we are the only company among our identified competitors that offers chemistry, biology, transcriptomics, proteomics and iPSC-based disease modeling with multi-modality expertise across small molecules, precision medicines, biologics, cell therapies and gene therapies, as well as manufacturing capabilities that span the drug development continuum, from discovery through commercialization.
We offer greater precision and higher efficiency than industry standards: The integration of precision and efficiency is in our view the solution to the industry’s challenge of constantly declining returns on R&D investments. Over the last 25 years, we have built what we believe is the most agile platform in the industry. Our proprietary discovery and development platforms leverage data, operational efficiencies, and technological capabilities to drive rapid progress and successful outcomes in the early stages of the R&D process. We also apply ML and AI to our novel molecular patient databases and disease models to generate and analyze data. Through greater precision and higher efficiency than industry standards, we increase the likelihood of success in clinical trials and provide solutions to the challenge of constantly declining returns on R&D investments.
Our patient-centric approach positions us at the forefront of precision medicine: We have built an advanced precision medicine platform that integrates molecular patient databases, our iPSC- based drug screening platform as well as our PanOmics and PanHunter platforms. We believe that the identification of disease-relevant molecular profiles in patients is fundamental for most precision medicine approaches, and we target the development of molecular patient databases in various disease areas. For example, our chronic kidney disease (“CKD”) database is derived from more than 12,000 CKD patient profiles and more than 3,000 in other disease areas. We have also developed one of the largest and most sophisticated iPSC platforms in the industry, which enables iPSC-based disease modelling and drug screening at an industrialized scale. We believe that patient-derived disease models are the new gold standard in profiling drugs at the pre-clinical stage of development, eventually leading to lower attrition rates during clinical trials. This helps us drive the paradigm shift toward individualized drug discovery and allows us to address diseases in a more precise manner tailored to molecular patient profiles.
Our modality-agnostic set of solutions maximizes the potential of our integrated technology platform: Our multi-modality platform ranges across small molecules, biologics, and cell and gene therapy. Our platforms are applicable to all modalities and lead to a modality-agnostic pipeline spanning a broad range of disease areas. We leverage our industry-leading iPSC platform for the development of next-generation cell-based therapies as well as disease modeling and drug screening.

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Our wide array of high-quality partnerships results in a deep, diversified pipeline: We are a partner of choice for leading pharmaceutical companies, small and large biotechnology companies, start-ups, academic institutions, patient advocacy groups, venture capitalists as well as foundations and mission driven not-for-profit organizations. Due to our value proposition for partners, we can retain significant commercial upside with all our assets that are partnered in the form of royalties, milestones, or equity stakes. Our pipeline benefits from our highly productive research collaborations and is designed to become one of the largest royalty portfolios in the industry. The value upside created by our pipeline comes at a low capital intensity and at an attractive risk-reward profile as our partners typically carry the clinical development costs of our assets.
Our people and culture place scientific excellence at the heart of everything we do: We are led by a strong management team with extensive industry knowledge and experience. We foster a culture of scientific excellence and problem solving, demonstrated by the scientific expertise and passion of our more than 4,000 scientists who work for Evotec. A large share of our employees holds at least one academic qualification, including a significant number with a Ph.D. or equivalent. We stay close to groundbreaking research through our numerous research collaborations with academic institutions such as Oxford, Heidelberg, UCLA and UKE. Our personnel strategy focuses on attracting, growing, and retaining talent, developing our leaders to be great leaders, ensuring a competitive reward system, and supporting our ONE Evotec culture. Our three core values that form the basis of our corporate culture are innovation, collaboration, and entrepreneurship. These values are consistent across interactions among Evotec employees and with our partners (two of our critical stakeholder groups) and are essential to our business model.

Our Growth Strategy

Our growth strategy aims to address the entirety of the R&D continuum by tackling the broadest range of disease areas utilizing a modality-agnostic approach. We believe we have built one of the most efficient integrated drug discovery, development and manufacturing infrastructures that generates the highest quality results in the fastest and most cost-efficient way. In addition, by leveraging the value of our platforms and sharing intellectual property, we seek to de-risk our portfolio through the breadth and diversity of pipeline assets. We aim to have over 170 pipeline assets by the end of 2025. Royalties contribute a small fraction of revenues today, but we anticipate they will become more meaningful by 2025.

Our strategies include:

Establishing Evotec as the premier innovator to discover and develop new medicines with partners: Our proprietary platforms aim to integrate traditional R&D capabilities with cutting-edge data analytics to deliver potentially best-in-class and first-in-class therapeutics that are designed to be patient-relevant, disease-modifying and have curative potential. Together with our partners we strive to be at the forefront of the ongoing paradigm shift toward precision medicine as our innovation hub allows for competitive predictive capabilities, provides better starting points for clinical research, and potentially increases the likelihood of success in clinical trials.
Strengthening our position as the premier partner to the life sciences sector: In the past, we have excelled in delivering drug discovery and development solutions, Our current offering and capabilities stretch significantly beyond traditional contract R&D and potentially hold the key to disruptive innovation in the life sciences sector. Our growth as a service provider is underpinned by the high quality we have delivered in the past and by the current breadth of our capabilities across modalities, technologies, and data-integrated R&D efforts. Our two-pronged growth strategy includes adding new customers and increasing the scope of work for existing customers.
Expanding the value of co-owned assets: To date, we have built a pipeline of more than 130 co-owned assets, with which a significant share is partnered. We expect our pipeline assets to provide a meaningful stream of milestones and royalties without direct exposure to trial costs. We expect our cutting-edge key platforms (PanOmics, PanHunter iPSC-based drug screening and cell therapy platform,) ranging across all relevant modalities to generate additional novel drug development candidates at a rapid pace. To find the right partner for each of these emerging assets and platforms we leverage our unique relationships with over 800 partners globally to ensure optimal development of our pipeline.

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Disrupting the biologics ecosystem through Just – Evotec Biologics toward access to medicines: Since the acquisition of Just – Evotec Biologics in 2019, we have witnessed increasing demand for its disruptive, flexible, and cost-effective method of biologics discovery and development. We believe to be well positioned to meaningfully affect the over $100 billion market for therapeutic antibodies and drive this market in a new direction. Evotec’s first J.POD manufacturing facility located in Redmond, Washington, United States, became operational in August 2021. In the first full year after opening the site in Redmond, the order book of Just – Evotec Biologics has more than tripled to more than $ 100 million as of December 31, 2022 compared to December 31, 2021 ($ 30 million). We believe that Just – Evotec Biologics will positively contribute to our goal to establish significant integrated long-term partnerships with the potential to generate milestones and royalties. Just – Evotec Biologics intends to expand its footprint including the construction of a second J.POD facility in Toulouse, France.
Identifying risk-balanced, high-reward opportunities through equity investments: Our ambition is to benefit from scientifically and commercially exciting R&D endeavors that are complementary to our R&D capabilities. As of December 31, 2022, we hold 31 investments and have seen significant scientific, strategic, financial, and corporate progress on many of these projects. We continue to evaluate closely evaluate potential opportunities with a favorable risk-reward profile on an ongoing basis to expand our ecosystem.
Leveraging the synergies between Evotec’s businesses: Our technology platforms and core collaboration routes have a highly symbiotic relationship. We are focused on fully integrating all its technologies, services, and enabling seamless cross-fertilization of knowledge and best practices. Our expanding molecular databases built up through PanOmics and analytical capabilities through PanHunter ensure that its AI and ML capabilities are constantly advancing. Higher-quality data and analytical capabilities have the cascading effect of enhancing the quality of innovation in all areas of our activities.

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Current Industry Dynamics Suggest the Need for a Disruptive Approach to R&D

The budget that pharma and biotech companies devote to R&D is determined by the amount of revenue they expect to earn from a new drug, the expected cost of discovery and development to the launch of the drug, and policies that influence the supply of and demand for drugs. In contrast to the development cost, which increased from $ 1.3 billion in 2013 to more than $ 2.2 billion in 2022 for the benchmark of the top 15 pharma and biotech companies, the average global peak sales per drug in the last decade declined by more than 25% from $ 520 million per drug in 2013 to $ 389 million in 2022. In line with this trend, commercial returns as measured by internal rate of return (IRR) have decreased by 42% – from 6.5% in 2013 to 3.8% in 2022. Global R&D spend grew by 63%, from $ 86 billion in 2013 to $ 139 billion in 2022.

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This all points to the need for a drastic shift in the R&D model to increase simultaneously increase the quality of drugs being developed while improving the potential for commercial returns. Around COVID time, the industry opened the perspective on disruptive R&D models. We saw progress in the willingness to collaborate, which however has partially cooled again. Across the board, we believe that the need for disruption remains as much in place as ever.

Evotec’s solution – Providing what the industry really needs.

We believe the existing capital-inefficient R&D model with its fully integrated, pharma-like value chains is no longer sustainable and, most importantly, no longer competitive especially when it comes to the development of medicines for small patient populations, be it precision medicines for specific patient segments or medicines for rare diseases. We deliver critical solutions such as enhanced speed to the clinic, better prediction of clinical efficacy and reduced manufacturing costs. We can deliver these critical solutions through a combination of:

Biology-driven patient-specific disease understanding and -insights.
Leadership in data generation, data analytics and AI/ML-supported efficacy and safety prediction
Modality agnostic expertise (e.g.,small molecule, biologics, cell therapy among others) that helps to make the drugs of our partners precise, affordable, and more accessible.

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We believe that the future of drug discovery and development requires the integration of different disciplines and approaches to generate treatments that are patient-relevant, disease-modifying and have curative potential. Our proprietary discovery and development platforms leverage data, operational efficiencies, and technological capabilities with the goal of driving rapid progress and successful outcomes in the early stages of the R&D process.

The key criterion for our decision-making is patient-relevant data, which facilitates a more stringent project prioritization cascade than typically observable in the industry. We can generate disease profiles at a large scale, providing a significant foundation of knowledge on which to base disease modeling and other drug discovery efforts. Our large suite of automated platforms ensures data integrity, prompt test responses and productivity. We create unique analytical packages for both our own programs and our partners’ programs, customized for each phase of development. Backed by a fully integrated drug discovery platform, all approaches are designed to contribute to the goal of improving productivity for our partners and increasing the number of our own assets, derived from our platforms, alliances as well as equity investments.

Finding the right drug for the right patient platforms underpinning our PanOmics- driven drug discovery for deep disease understanding and effective therapies

We believe our patient-centric and disease relevance-focused approach will guide us to find the right drug for the right patient at the right dose much earlier in the drug discovery and development process by determining disease relevance right at the outset of the drug discovery and development phase instead of during clinical development, which has been the traditional approach. PanOmics- driven drug discovery for deep disease understanding and effective therapies and data analytics via PanHunter in combination with high-throughput iPSC-based disease modeling drive the foundation of our industrial scale AI, ML and precision medicine platform. These hold the key to driving innovation within many of our internal R&D and partnered programs.

Evotec’s precision medicine paradigm determines disease relevance right at the outset to increase clinical success rates.

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(1)Regulatory Toxicology and Pharmacology; Volume 32, Issue 1, August 2000; Pages 56-67; Journal of Health Economics Volume 47, May 2016, Pages 20-33; Clinical development success rates for investigational drugs; Nature Biotechnology volume 32, pages 40–51(2014); Evotec estimates.

PanOmics data generation—Industrialized high-throughput multi-omics platform.

Our approach to precision medicine is based on multi-omics. Generally, -omics technologies are widely available and often used, however they are not routinely applied to drug discovery and development. For example, when it comes to genome sequencing, the industry has simply not sequenced enough genomes and effectively connected these to medical data to learn what the average genome tells us about expressed phenotypic characteristics. This means that genome sequences only provide a glimpse of a patient’s predispositions to disease and do not measure disease status or disease progression. For this, transcriptome and proteome data are needed.

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Transcriptomics and proteomics allow us to measure directly how a genome interacts with the environment in the context of an organ, tissue, or cell. As transcriptomics and proteomics are unbiased and provide comprehensive readouts, they are crucial for a better understanding of disease processes and disease-relevant molecular mechanisms. These technologies have not been scaled to a similar extent as genome sequencing. We believe the development of higher throughput transcriptomics and proteomics will allow for the routine use of these technologies across the drug development value chain. The two key drivers are lower costs to generate data and the adoption of machine-learning tools that support the analysis of big -omics data.

We have been particularly focused on industrializing our transcriptomics and proteomics platforms so that they can be fully integrated into our mainstream drug discovery processes. We believe our 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

High-throughput transcriptomics is necessary to build large molecular patient and drug discovery databases effectively. We have 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 us to effectively bridge the gap between pre-clinic and clinic. Finally, we have ensured that all of this can be done at reasonable costs for the vast amount of information a transcriptome analysis provides for every single compound.

ScreenPep—High-throughput proteomics

Like ScreenSeq for high throughput transcriptomics, our scientists have developed ScreenPep, providing what we believe 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, we have worked to improve the throughput of our 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 our PanOmics platform is our molecular patient-derived disease database in the field of CKD. CKD is far from uniform, so we believe that gaining a better insight into the molecular level is the only way to develop curative therapies. For example, the category of glomerular kidney diseases consists of many different diseases that are driven by vastly different disease mechanisms. Only if these mechanisms are better defined and understood will we be able to develop better medicines.

To develop a comprehensive patient derived database in the field of CKD, we 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 our 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. The aim of the consortium is to provide access to thousands of kidney patient-derived samples and data sets to characterize human pathology and to provide detailed histological and molecular analysis.

Utilizing the PanOmics data generation platforms, we 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. We have continuously expanded this database, which is based on data from over 10,000 CKD patients. To our knowledge, this constitutes by far the largest CKD patient molecular database worldwide and now constitutes more than six hundred billion data points according to our internal calculations.

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Based on the strength of our molecular CKD patient database, we have 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 our JV NephThera. Our collaborations are structured as multi-target agreements pursuant to which an undefined number of targets may be pursued. Our agreements allow us to scale our business via entering multiple collaborations in the same disease area. We and our partners share responsibilities during discovery and pre-clinical development. If a candidate progresses to clinical development, our partner is fully responsible, financially, and operationally, for development, regulatory approval, and commercialization, and we have the right to receive R&D and sales milestones, as well as royalties on commercial sales. Depending on the nature of the product candidate (e.g., small, or large molecule), potential R&D milestones range from €3.8 million to €37 million on a per product basis. If the candidate receives approval, we are generally entitled to sales milestones that range from $60 million to $250 million per-product, along with royalties between 0.5% and 10% of net sales. The research term is approximately five years. The agreements expire upon the expiry of the last patent of the asset developed under the agreement, unless terminated earlier by either party. The agreements permit our counterparties to terminate the agreement without cause by giving written notice, usually six months. Either party may terminate the agreements prematurely for cause after the other party’s uncured material breach or bankruptcy or insolvency. See “Risk Factors—our business depends on our and our partners’ success in innovation and drug development, which is highly uncertain.”

E.MPD - Expanding from CKD to other disease areas.

While our molecular patient database in CKD is the advanced, we aim to advance several additional proprietary molecular patient databases in other disease areas (e.g., Oncology, Cardiology). The opportunity to derive new targets and therapies in these disease areas is tremendous, and we aim to capitalize on these databases via additional strategic alliances.

Deep understanding of biology with molecular signatures - Molecular Patient Database (E.MPD)

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PanHunter — Advanced multi-omics data analysis and prediction platform

With industrialized systems for generating high-throughput data, the amount of genomics, transcriptomics, proteomics, and metabolomics data (hereafter omics data) generated is growing exponentially. More omics data have been generated in the last two years than in all previous years combined. To ensure disease relevance and patient centricity in the drug discovery process, such omics datasets must be correlated with preclinical and clinical metadata as early as possible. These datasets then contain an overwhelming amount of information about each patient’s condition, molecular biology context, and causes of disease. To gain insights from this vast number of high-dimensional datasets, sophisticated computational analysis is required.

PanHunter addresses these challenges as it is an enterprise-level multi-omics data analysis platform that enables scientists to work with large data sets in a very user-friendly way. The platform consolidates the analysis of various data sets, including clinical data (demographic information, medication, co-morbidities), metadata (gene/protein information, experimental parameters), chemical data (structures, compound information, drug databases), as well as knowledge from the public domain (datasets and literature information), biomolecular databases and other resources (e.g., Wikipathways).

Having developed and successfully deployed PanHunter internally and in industry-defining drug discovery partnerships over many years, Evotec made PanHunter available to its collaborators and partners as a software-as-a-service (SaaS) product in 2022, after investing significantly in the platform’s additional scalability, security, and performance.

Once data is uploaded to PanHunter, the platform allows users to freely interact and combine data in a web-based system. Results are presented immediately and can be interpreted or used as input for subsequent steps of data analysis. This rapid feedback is a key advantage of PanHunter that distinguishes it from other tools, particularly the classical pipelining approach in bioinformatics. Users, typically biologists, computational biologists, or bioinformaticians, can accelerate their research by having all the tools available in one system: from initial dimensionality reduction plots to differential gene expression analyses to very detailed molecular pathway analyses, signature generation, gene set enrichments, meta-analyses, and many options for creating plots to visualize and support results. For specific data, such as single-cell or single-nucleus transcriptomics, specialized applications are provided to facilitate the analysis of large datasets. 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 our 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. By the time these failures occur, costs are already material. With better tox-prediction available at the discovery stage, these failure rates have the potential to be reduced dramatically. In our models, the combination of PanOmics with PanHunter has resulted in a superior prediction rate for DILI of 86%. This compares with the current gold standard relying on high-content imaging endpoints, which has a 70% prediction rate, and animal models, which has prediction rates as low as 50%.

Aside from toxicity prediction, we believe that better ways to evidence the efficacy of drug candidates are needed. In our view, this can only be achieved by linking patient-derived data generation with a suitable data analysis platform like PanHunter. Over 54% of drugs in Phase III, clinical trials fail. Of these, 57% fail due to inadequate efficacy, which means that many projects continue for many years pursuing the wrong target or developing compounds that are simply not good enough. Ultimately, only approximately 9% of Phase I biologics receive approval. For this reason, there should be more emphasis than ever on demonstrating the disease relevance of targets and compounds at a much earlier stage in the R&D process.

In addition, we believe it is necessary to measure disease relevance relative to the molecular patient profiles that we know are associated with the disease. As outlined above, we believe this can be achieved through a greater focus on unbiased and comprehensive measurements such as transcriptomics and proteomics, which are uniquely suited to measuring disease status and progression because they capture more complex molecular disease profiles. We believe that AI-based analytical tools can support the identification of mechanisms and targets that can be uniquely linked to patient subpopulations defined by molecular phenotypes to achieve relevant outcomes in a reasonable timeframe.

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iPSC—A new paradigm in human disease modeling

To accelerate the paradigm, shift toward precision medicine, since 2012 we have developed an industrialized platform that builds patient-derived assay systems and disease models through iPSC technology. We believe that our iPSC platform is one of the largest and most sophisticated in the industry, and we have focused on industrializing iPSC-based drug screening so that we can increase the reproducibility and robustness of such screening. We have achieved industrialization by standardizing and scaling up the process of creating patient-derived iPSC for disease modeling and drug screening.

We initially developed our 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. We anticipate 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.

Neurological diseases, such as Alzheimer’s, amyotrophic lateral sclerosis (ALS) and Huntington’s disease, remain a major challenge for therapeutic drug development due to poor understanding of disease pathophysiology and insufficient representation of these diseases in animal models. Furthermore, in several cases, positive efficacy results observed in pre-clinical animal models have not been reproduced in clinical trials. Based on our expertise in CNS diseases, we believe that existing disease models in this field are suboptimal because the use of immortalized or primary cells has limited disease relevance and is not scalable. For these reasons, we believe it is essential to develop better predictive, ideally human, disease models that generally reflect human disease and disease phenotypes more accurately. Accordingly, we attempt to achieve this objective through the application of our iPSC platform, which is focused on patient-derived iPSC models because they are more suitable for modeling neuronal diseases than other systems.

iPSC Technology shifts the drug discovery paradigm:

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iPSCs can be reprogrammed from various patient cells (e.g., skin biopsies or blood) and can proliferate unlimitedly and differentiate into almost any cell type of the human body. Most importantly, they have been shown to replicate disease mechanisms that are found in humans. With our 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 us to stratify patient populations and explore at the outset whether a drug is effective for all patients or only subpopulations. With this, we obtain highly valuable information for clinical trial design, so we can ensure that we not only select the relevant patients for clinical studies but also use this new drug with relevant patients in a commercial setting.

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For accurate disease modeling, it is essential that all protocols we establish work across multiple iPSC lines to capture the highly diverse genetic causes for many diseases. Together with our partners, we have 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. We are also advancing our stem cell research platform for disease modeling and screening to develop reliable, scalable, and automated manufacturing processes. All our 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.

We expect 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 our iPSC-based disease models. This program is expected to progress to the clinic in less than five years as part of our broad and exclusive neurodegenerative disease collaboration with BMS. More broadly in iPSC, we have developed over 350 patient-derived cell lines for disease modeling across more than 15 disease areas, for which our main alliances include neurodegeneration and Huntington’s disease. To continue to build our capabilities, we intend to expand our 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 our advanced approach to designing, discovering, developing, and manufacturing modern bio-therapeutics. We believe that Just – Evotec Biologics positions us well to establish further significant long-term, integrated partnerships with the expansion of our solutions into highly efficient and flexible biologics manufacturing. This differentiated offering is available to our partners on a fee-for-service and/or FTE-rates-based model as well as through arrangements that involve milestones and royalties.

Evotec acquired Just Biotherapeutics (subsequently renamed Just—Evotec Biologics) in 2019, which represented our entry into the large and growing market for commercial biologics and expanded our multi-modality capabilities. The founding and original concept of Just—Evotec Biologics was to create an agile, flexible, and cost-effective method of biologics discovery, development, and manufacture to enable affordable global access to modern biologics therapies. This powerful, horizontally integrated end-to-end system is called J.DESIGN.

J.DESIGN is our 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 resulting efficiency of our fully integrated end-to-end platform offers partners the opportunity to capitalize on more agile and cost-effective manufacturing, scaled accordingly for the stage of development and size of the patient population. This flexibility is of critical importance as novel biologics increasingly enter highly complex disease indications with less certain outcomes. Additionally, we anticipate that increased speed and flexibility as well as reduced costs of the discovery and development processes will allow us to gain significant market share in rare disease and orphan indications as well as in the field of biosimilars where pricing can be competitive.

We are applying AI and ML to create and select high-quality molecules in discovery that in turn drive more productive manufacturing processes. Our technology enables continuous feedback, machine learning and model refinement to drive further improvements in speed, quality, and cost. This learning loop is best represented as a circular “flywheel,” which gets better and more efficient with each turn.

We anticipate 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.

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J.DISCOVERY—Antibody Discovery

To create antibody therapeutics, we utilize our J.DISCOVERY approach to build a large and diverse antibody library we call 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. Since we can train J.HAL with different sets of antibodies exhibiting a variety of biophysical properties, we can bias J.HAL to generate DNA sequence coding for antibodies that can be developed and manufactured efficiently and may have superior properties for addressing a specific disease target. We call the billions of antibody sequences in our J.HAL library “Humanoid” because they are indistinguishable from human antibodies, even though they are created computationally. The full power of disease knowledge and pharmacology expertise across Evotec ensures comprehensive pharmacological and safety understanding in tandem with developability and manufacturability. As we have control over the processes of discovery, development, and manufacturing, we can feed this information back and dramatically expand J.HAL based on experience and validation. The desired outcome is the creation of antibodies that are safe, developed quickly and cost-effectively and with the potential of greater efficacy.

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, we create learning algorithms that enable scientists to predict the best molecules and conditions for development. Molecules are then evaluated using assays that indicate how well a molecule is expressed, purified, and formulated. Any information learned from evaluating the molecules is subsequently used to improve further the toolset for future molecules.

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 ultimate physical representation of the transformation of the biologics discovery and development continuum is the J.POD facility. To remain competitive, companies require flexible manufacturing solutions with the right capacity at the right time and smart, high-yielding processes to increase efficiency by cost-effective and faster manufacturing without any sacrifices to quality and safety. J.POD is the manufacturing and plant design aspect of J.DESIGN, which achieves these objectives.

J.POD accelerates the development of highly productive processes that can be executed in relatively small unit operations and still make enough product to meet almost all commercial market needs in a single facility. These highly intensified processes reduce the size of unit operations to fit into relatively small, flexible “PODs” or cleanrooms and become the core manufacturing space in a J.POD facility. Since the entire process train uses single-use technology, central and capex intense utilities like “clean in place” or “sterilize in place” systems are eliminated, as well as the large amount of stainless-steel piping and large stainless-steel vessels that must be precisely built and validated. In addition, PODs, and the equipment they contain can be built and assembled while the plant is being constructed so that the time and complexity of validation are dramatically reduced. The modular, flexible, and less capital intense setup creates the opportunity for a global network of J.POD facilities, leading to better and cost-effective access to biologics in areas of the world that have not been served thus far.

Finally, instead of increasing the size of bioreactors and processing steps to expand capacity (as in traditional large-scale manufacturing facilities), additional bioreactors of the same size are essentially “cloned.” In essence, we “scale-out” rather than “scale-up” and effectively reduce scale-up risks by manufacturing at the same scale from early clinical development through commercial manufacturing. Our processes are highly “intensified,” using continuous perfusion and connected downstream processing to make large amounts of high-quality drug substance with a relatively small bioprocessing footprint.

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We completed construction on our first J.POD manufacturing facility located in Redmond, Washington. The facility became operational in August 2021. Ground-breaking of the second facility in Toulouse, France took place in September 2022, and we anticipate the European facility to be complete in the second half of 2024. Our vision is to create a global network of highly standardized manufacturing sites that can serve local demand.

We have 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 2020, the U.S. Department of Defense awarded Just—Evotec Biologics an order for the development of a highly efficient manufacturing process for monoclonal antibodies against COVID-19, followed by a manufacturing agreement in January 2021. The mAbs will be tested in clinical trials and, if approved, could be used for the treatment and/or prevention of SARS-CoV2 infections. Just – Evotec Biologics intends to use its experience in process development and clinical manufacturing to enable the realization of these potentially critical protein therapeutic treatments against SARS-CoV2 infections.

In October 2020, Just—Evotec Biologics received funding from the Bill and Melinda Gates Foundation as part of the COVID-19 Therapeutics Accelerator initiative to support the development and manufacture of monoclonal antibody (“mAb”) candidates for the prevention of severe COVID-19 cases in vulnerable populations in low and middle-income countries. Under the grant, Just – Evotec Biologics uses its proprietary software toolset Abacus™ to perform an in-silico analysis of several lead candidate sequences of potent anti-SARS-CoV-2 mAbs provided to the foundation by several leading academic medical centers around the world. Abacus™ analysis identifies key sequences that can affect developability and, if required, make recommendations to optimize the anti-SARS- CoV-2 antibody candidates. In addition, Just – Evotec Biologics will perform cell line development for two lead molecules.

In our view the ultimate external proof of concept was achieved after the opening of the J.POD facility in 2022 with the signing of two contract extensions/expansions.

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. Commercial process development activities will be performed at Just – Evotec Biologics’ J.POD biomanufacturing facility in Redmond, Washington.

In September 2022, the U.S. Department of Defense (“DOD”) has awarded Just – Evotec Biologics a contract valued up to $ 49.9 million for the rapid development of mAb-based drug product prototypes targeting plague. Plague, an infectious disease caused by the bacterium Yersinia pestis (“Y. pestis”), is one of the designated targets of interest under the DOD’s Accelerated Antibodies Program. Under the contract, Just – Evotec Biologics will develop mAb-based drug product prototype(s) from sequence discovery or evaluation of existing mAbs to completion of Phase I first-in-human (“FIH”) clinical trials. To enable rapid development, Just – Evotec Biologics will leverage its data-driven, highly automated end-to-end biologics technology platform, J.DESIGN, that includes antibody discovery (J.HAL), molecular optimization, cell line and process development, and continuous manufacturing at its J.POD Redmond, Washington (U.S.) facility. In addition, Evotec will provide pre-clinical and clinical capabilities for mAb prophylactic approvals.

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iPSC-based “off-the-shelf” cell therapies based on induced-pluripotent stem cells

In addition to disease modelling, we use our iPSC platform to develop the next generation of cell-based therapies. Our iPSC cell therapy portfolio spans metabolic diseases, immuno-oncology, and heart repair. We plan to further expand and invest in our 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. We have expanded our cGMP production capacities with the acquisition of Rigenerand (now operating under Evotec Modena Srl.) offering the ability to scale up and accelerate development of material sufficient to run phase II clinical trials.

Our most advanced candidate in the field of iPSC-based regenerative medicine is our QRBeta initiative, aimed to cure patients suffering from type I diabetes. In in vivo models, we have demonstrated a durable normalization of blood glucose levels with our 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. Our 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 our project together with Sernova:

Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the ability to store batches of differentiated islet-cell clusters.
Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent safety profiles in a gold standard T1D preclinical model with Evotec’s iPSC-derived islet-like clusters transplanted in Sernova’s Cell Pouch
iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec’s iPSC GMP facility are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply.

Based on these achievements, we target to start a first phase I clinical trial with the combination of our iPSC derived islet-like clusters transplanted in Sernova’s Cell Pouch by 2024.

In 2021, we advanced our 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. Under the terms of the partnership, Evotec and UKE will leverage their complementary strengths for the development of a new cell therapy approach using iPSC-derived heart muscle cells for the treatment of heart failure. We expect to leverage our industry-leading human iPSC platform to establish GMP-compatible process development and upscaling for large-scale generation of clinical-grade heart muscle cells known as cardiomyocytes. We also plan to contribute genetically modified GMP iPSC lines, which contain alterations preventing rejection of the cardiomyocyte-containing product by the patient’s immune system and include additional safety mechanisms to control unwanted proliferation of graft cells. By using GMP-grade iPSC lines, the collaboration is intended to deliver off-the-shelf products that can be implanted in broad patient populations with little to no immunosuppression. UKE will contribute its heart injury animal models to assess product efficacy as well as an innovative strategy to prevent arrhythmia. In vivo validation and development activities will be shared jointly between Evotec and UKE. We 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, we are building a portfolio of “off the shelf” iPSC-derived immune effector cells to overcome the hurdles of current autologous cell therapies in oncology such as long vein-to-vein times, limited manufacturing reliability, logistic challenges, and high price points. In the future, we plan to target the development of a comprehensive portfolio of innovative immuno-oncology programs. At this stage, our portfolio comprises of iPSC derived Natural Killer Cells (EVOcells iNKs), Macrophages (EVOcells iM) as well as αßT-cells and γδT-cells. We have signed a first collaboration in this field with a leading pharma company after period-end.

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End-to-End Shared R&D - Integrated business-to-business platform for increased probabilities of success from target to the patient

We believe that our End-to-End Shared R&D platform, differentiates us from competition as the organization is able to deliver fully integrated drug discovery and development programs to our partners. Our 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 our experienced scientists—result in significantly improved speed, quality, and cost of drug discovery. Our highly qualified and experienced team is what makes it unique. Our fully integrated, industrialized, high quality and comprehensive infrastructure is utilized across all our core collaboration routes.

Our 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. We possess 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. Our biomarker strategy and resources provide tailor-made biomarker solutions using state-of-the-art technologies. From our position of strength in chemistry and small molecules, we have added capabilities for additional modalities, such as biologics, proteins, RNA, and antibody-drug conjugates. Our 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, we approach drug discovery and development as a continuum instead of disparate processes. We focus 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, we allow for smooth transitioning from discovery and preclinical development into the clinic through our INDIGO solution. We believe INDIGO provides best-in-class governance structures and capabilities to supply fit-for-purpose resourcing, key expertise, decision-gated strategies, clear and timely communication and seamless interactions between our partners and our functional teams. Within the structure of a project or partnership, we focus on the success of the inventive step in every discipline through a combination of knowledge, experience, computational power, and process excellence.

Our integrated approach to R&D has helped us to outperform well-recognized industry benchmarks. Recent benchmark data show that the costs and timelines for drug discovery have not improved in the last ten years. Including the cost of attrition, it takes companies approximately $75 million to initiate a single regulatory toxicology study and around 5.5 years to proceed from a target to a first good laboratory practice toxicology dose or IND submission. In contrast, our integrated offering through EVOiR&D has achieved portfolio delivery to IND submission at up to half the cost and in up to 30% less time. This time saving is crucial as the potential to reach an IND up to 18 months faster means acceleration of the potential availability of innovative breakthrough medicines to the patient community and for difficult-to-treat diseases. It also generates significant benefits to our partners and ourselves in a highly competitive marketplace where many players are pursuing the same scientific concepts and there is a race to be first-to-market.

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EVOiR&D’s Potential Impact on Early-Stage Clinical Development

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(1) Including attrition; DMTA = Design make test analyze; Source Clarivate, 2018

Business models

Our 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.

We maintain a large portfolio of partnered pipeline assets generating revenues from upfront and milestone payments as well as several unpartnered pipeline assets that we are progressing for future partnering. We expect the relative share of revenues from milestones and royalties as a percentage of total revenue to increase as our pipeline matures over time.

As an external innovation partner to the life science industry, we provide stand-alone or fully integrated drug discovery and development solutions to our partners using our 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.

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Our solutions can provide unparalleled breadth and depth to clients. We can support our 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. We also possess 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. We believe the quality and breadth of this real drug discovery engine is highly differentiated in the market.

In 2022, 73% of our 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, we expect 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, we foresee 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), we have 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 now involve our proprietary and premium platforms. In connection with such platforms, we seek to structure integrated alliances in which we 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 our 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 our Fee-for-Service and FTE-based Business models

1)  Share of Annual Repeat Business

We have demonstrated solid customer retention rates, as defined by the percentage of revenues from customers with whom we had a relationship within the prior year, above 90% in each of the last three years. We review our repeat business on a yearly basis. Repeat business was 92% in 2022 and 91% in 2021, respectively.

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2)  Customer Evolution and Contribution

Graphic

The number of our customer alliances has expanded significantly in recent years, providing further validation of our services provided. During 2022, we added 325 new customers compared to 337 in 2021. The number of customer alliances that generate revenues of more than €1.0 million per year has continued to rise and reached 118 in 2022 (2021: 97), or 14% (2021: 12%) of total customers in the last two years, pointing to increasing entrenchment with each customer.

3)  Reduction of Customer Concentration

Our customer and revenue bases have become more diversified over the last three years as revenues have grown significantly. Our top ten customers’ contribution to total revenues amounted to 39% in 2022 versus 46% in 2019, pointing toward a steady decrease in revenue concentration among top customers. The decrease versus 2021 (42%) was achieved despite a significant milestone payment from BMS after a successful transition into the clinical trial stage in 2021. Our largest customers by revenue, BMS, Merck and Exscientia, accounted for 25% of group revenues in 2022. Other than BMS, no single customer contributed more than 10% of group revenues.

Pipeline building—Co-owned and Shared assets

We leverage our proprietary technology platforms to develop new drug discovery projects, assets, and platforms, both internally and through collaborations. This approach allows us 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 our proprietary technology platforms, we expect to enter collaborations involving success-based milestone payments and royalties. Our goal is to increase the revenue contribution from these collaborations over time through the maturation of our pipeline significantly by 2025.

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Benefits to us from our EVOroyalty business model include:

Milestones and royalties-based revenue to secure and accelerate profitability.
A risk-reduced development pathway for drugs given the ability to combine Evotec and partner R&D capabilities and expertise.
Deepen our knowledge base of high-quality R&D capabilities; and
Validation to build out a broad early-stage pipeline.
Superior organic growth based on high-margin contracts
Expansion of existing and conclusion of new integrated service alliances (Approval of SKY Covione (COVID-19) with SK bioscience in South Korea, first royalties)

We believe we possess one of the broadest and deepest pipelines in our industry. Since 2015, the number of our assets has more than doubled to more than 130 with one approved asset and 18 disclosed assets in clinical development at the end of 2022. 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. We define our pipeline to include candidates that we wholly own and those for which we have the right to receive royalty or milestone payments. For candidates for which we have the right to receive royalty or milestone payments, we, 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 our partners and that have become the subject of a joint research project pursuant to which we are eligible for royalty or milestone payments.

Beyond therapeutic areas, we have also successfully expanded our pipeline across multiple modalities. In 2015, our 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. Given the breadth and depth of our pipeline across therapeutic areas, modalities, and stages of development, we believe that the risk-reward profile of our pipeline is unique in the industry.

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Pipeline Projects - Number of projects is constantly growing

The table below outlines our pipeline assets by therapeutic area and stage of development. Our partnered pipeline includes those assets we have developed and licensed or assigned to partners for clinical development and commercialization as well as the assets of our partners for which we are entitled to receive potential royalty or milestone payments (dark blue boxes). Our unpartnered pipeline consists of assets we are developing internally but with whom we have not yet partnered. Our equity pipeline is comprised of the assets under development by companies in which we have made an equity contribution through EVOequity. We expect to realize returns on our equity pipeline primarily from successful exits but also from fee-for-service and FTE-rate-based revenues from these companies. Our BRIDGES pipeline represents the assets under development through our joint ventures with academic institutional partners as part of our project incubation program to promote the early development of academic research. Note that the assets shown here as part of our equity and BRIDGEs pipelines are not included in the number of our pipeline assets described elsewhere in this annual report.

Graphic

1) Also includes Women‘s Health, Respiratory projects.

EVOequity

We facilitate the acceleration of innovation as an operational venture capital provider providing capital and access to our industrialized and integrated technology platforms, expertise, and network. We make equity investments in products, technology platforms and companies through which we obtain early access to innovation and derive upside through our role as an operational partner. We see significant potential for value creation from EVOequity over the coming years from new partnerships, clinical successes, and positive commercial developments because we expect to drive the valuation of individual portfolio companies. We expect to realize returns on investments both from successful exits from our portfolio companies and fee-for-service and FTE-rates-based revenues with our portfolio companies.

As shown in the graphic below, we recognize various starting points to fuel our EVOequity portfolio. One of the key sources is risk-shared venture creation involving spinouts of our proprietary assets into separate legal entities or joint ventures with partners. We also invest in early-stage development companies that start out as our customers and engage us to conduct for them drug discovery work on our platforms. Investing in those companies helps us create long-term relationships and facilitates access to innovation in the treatment areas in which we specialize. These companies may originate from our BRIDGEs program, where Evotec collaborates with academic institutions to facilitate the acceleration of academic innovation without compromising precision or safety. We also identify investment opportunities by evaluating external opportunities.

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EVOequity’s strategy started with the creation of Evotec’s spinouts of Topas Therapeutics in 2016. Since then, our portfolio of equity holdings has grown steadily, and as of December 31, 2022, we have 33 equity engagements with 120 active projects in our 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). Our ownership ranges from 1% to 50% in equity per company, and we typically aim for an investment period of five to seven years. Investments with a share greater than 20% are recognized in our accounts “at equity”. Since the inception of our EVOequity strategy, we have invested €160.5 million and expect to accelerate those investments over the coming years.

Many of our portfolio companies have started out as our customers or have become customers either in parallel or after our equity investment. For example, Vifor Pharma – Now CSL Ltd. – has been a customer of Evotec for many years, and more recently, we have collaborated on early development in nephrology, which has led to the establishment of our joint venture, NephThera. In 2022, Vifor was acquired by CSL Ltd.., and continued collaborating with us on unchanged terms. With other equity holdings such as Blacksmith and Aeovian, we have an operational relationship through signing a master service agreement in parallel to our investment into the company.

Typically, we support the development of our equity investors’ in-house projects from early discovery up to IND-enabling studies and chemistry, manufacturing, and control.

An important structural difference to conventional venture capital models is our operational relationship with the portfolio companies and that our investment decisions often benefit from robust datasets that we have generated in-house on our industrialized and scalable platforms. Because we believe that we can make better-informed decisions through this approach, we see realistic chances of investment returns that could exceed venture-capital-like returns. Our typical equity investment is structured in such a way that we aim to obtain control of material stakes between 20% and close to 50% in the first financing round. Subject to dilution in subsequent rounds, these holdings may vary. On a case-by-case basis, we may invest in subsequent financing rounds. In the case of spinouts, we contribute in kind to leverage our in-house capabilities and accelerate innovation.

BRIDGEs

We believe that academic settings serve as a major source and point of origination and discovery of new targets and drugs. For example, approximately 25% of drugs ultimately approved by the FDA originate from academia, according to a study published in Nature investigating the contribution of different types of organizations to drug innovation. Universities are a major source of current and future drug targets. We seek to address the lack of funding and access to expertise for translational projects from academia, which is one of the main hindrances to efficient innovation. While there is a lot of support to initiate basic research projects, funding options tend to narrow down as the development of translational projects progress and there is often a lack of commercial understanding on how to advance assets to the next stage. At the same time, there is a need for validation of academic findings on industry-grade platforms to increase data quality and reproducibility, which we address with our model.

We have positioned ourselves as a leading company for the accelerated translation of academic assets by initiating “BRIDGEs,” our 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, we utilize our technology platforms to facilitate the acceleration of academic innovation. The global rollout of BRIDGEs is currently underway with a geographic focus on North America and Europe and Asia as an expansion target. BRIDGEs provide us with access to a broad portfolio of first-in-class therapeutics across academic institutions. We serve 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, we have 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: (i) 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. To date, we have 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.

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LAB282

In November 2016, we 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. The goal is for LAB282 to generate and accelerate the achievement of pre-clinical proof of concept results for new drugs and to generate eventual spinout companies. To date, LAB282 is responsible for 38 active or completed projects. Pursuant to the partnership, we exclusively contribute our drug discovery expertise and platforms to select projects and develop them further. We will be entitled to equity in new LAB282 spinout companies together with Oxford University and its academic researchers and together with OSI will have the right to co-invest in seed financing rounds. The pipeline assets being developed pursuant to the partnership are in the pre-clinical stages.

Autobahn Labs

In June 2020, we 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, we announced the launch of beLAB2122 and in May 2021, we announced the launch of beLAB1407. Both LABs are translational BRIDGEs funded with $20 million each, in collaboration with BMS. 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. Both BRIDGEs have the goal of efficiently advancing first-in-class therapeutic options across all therapeutic areas and formats into investable drug discovery and early development projects. In Germany, mediated and supported by BioRN, the Life Science Cluster Rhein Neckar, beLAB2122 brings together the European Molecular Biology Laboratory, the German Cancer Research Centre, the Goethe University Frankfurt, the University of Heidelberg, and the University of Tübingen in one collaboration with industry partners. beLAB1407 brings together the universities of Birmingham, Edinburgh, Nottingham, and Dundee in a collaboration with industry partners.

46

Summary of Equity Holdings, including BRIDGEs as of December 31, 2022

Company

    

Focus

    

Equity stake

Aeovian

 

mTORC1 inhibitor

%

3.79

Ananke Therapeutics

 

RNA binders’ oncology

 

20.09

ArgoBio Studio

 

Multiple

 

10.02

Aurobac Therapeutics SAS*

Antimicrobial Resistance