A. Reserved
B. Capitalization and indebtedness
Not applicable.
C. Reasons for the offer and use of proceeds
Not applicable.
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D. Risk factors
Our business is subject to significant risks. You should carefully consider all of the information set forth in this annual report and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”), including the following risk factors which we face, and which are faced by our industry. Our business, financial condition, or results of operations could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described below and elsewhere in this annual report and our other SEC filings. See “Special Note Regarding Forward-Looking Statements” above.
Risks related to our financial position and need for additional capital
We have a limited history of operating our current business, which makes it difficult to assess our future prospects and financial results.
Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. Our operations to date have been generally limited to developing our technology and undertaking preclinical studies and clinical trials of our investigational product candidates. We may not have the ability to overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical sector. In 2020, we transitioned from a clinical-stage to a commercial-stage Company following marketing authorization of Jyseleca® (filgotinib) for the treatment of rheumatoid arthritis in the European Union and Japan. However, in January 2024, we announced the completion of the transaction to transfer the Jyseleca® business to Alfasigma. As a result, we became a clinical-stage Company in the field of oncology and immunology.
In January 2025, we announced our intention to separate into two publicly traded entities resulting in the discontinuation of our small molecules oncology and immunology discovery programs that would have impacted approximately 300 positions across our sites in Europe. In May 2025, a strategic update regarding the separation was issued. Following regulatory and market developments, our Board of Directors decided to re-evaluate the previously proposed separation and to explore all strategic alternatives for our cell therapy activities. In October 2025, we announced our intention to wind down our cell therapy activities, following a comprehensive review of strategic alternatives including a potential divestiture. After the completion of the works council processes in Belgium and the Netherlands, we announced that the Board of Directors decided to initiate the wind-down in January 2026. As a result, all cell therapy activities will be wound down and approximately 365 employees across our sites in Europe and the U.S. will be impacted. We additionally determined to focus on strategic business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition of product candidates that we believe to have commercial potential. We have limited historical profit from product sales and limited historical data on product revenues, which sales and revenues are not reflective of our current pipeline or business. We have also operated under this business strategy for a limited period of time, and consequently, we have no meaningful operations upon which to evaluate our business. As such, the ability to predict our future operating results or business prospects is necessarily more limited than if we had a longer operating history or approved products on the market.
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With the exception of the years ended December 31, 2019, 2023, 2024 and 2025, we have incurred significant operating losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
With the exception of the years ended December 31, 2019, 2023, 2024 and 2025, including our discontinued operations, we have incurred significant operating losses since our inception in 1999. We reported a net profit of €211.7 million for the year ended December 31, 2023, a net profit of €74.1 million for the year ended December 31, 2024, and a net profit of €320.9 million for the year ended December 31, 2025. Our profit for the year ended December 31, 2025 was primarily due to the release in revenue of the remaining deferred income balance related to the OLCA for €1,069.0 million. Our losses resulted principally from costs incurred in R&D, preclinical testing, clinical development of our product and our product candidates, as well as costs incurred for research programs, pre-commercial activities, commercial activities (as of 2020), and from general and administrative costs associated with our operations. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our shareholders’ equity and working capital. We expect to continue incurring significant research, development, and other expenses related to our operations, and given the 2025 recognition of the full amount of the deferred revenue liability related to the OLCA, going forward we expect to incur operating losses for the foreseeable future.
In connection with the transfer of the Jyseleca® business, we received a €50 million upfront payment from Alfasigma, plus €9.8 million for cash and working capital, and will receive potential future sales- based milestone payments totaling €120 million and mid-single to mid-double-digit earn-outs on European sales. Other than such potential milestone and earn-out payments, we do not expect to generate significant revenues. In addition, we contributed €25 million to Alfasigma in June 2025 for Jyseleca® related development activities.
If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if any of our product candidates, if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
Additionally, we may not achieve significant revenues from sales of products. Therefore, even if we are able to generate revenues from the sale of any approved product, we may not become profitable or sustain profitability.
We may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
Our operations have consumed substantial amounts of cash since inception. During 2025, we conducted clinical trials for GLPG5101, GLPG5201, GLPG5301, and GLPG3667 and discovery and preclinical activities for other oncology and immunology product candidates. Following the completion of the wind-down of our cell therapy business and until such time, if ever, as we are able to acquire or develop additional product candidates, our only product candidate in development will be GLPG3667. Acquiring and developing pharmaceutical product candidates, including conducting clinical trials, is expensive. We will require substantial additional future capital in order to identify and consummate strategic transactions to acquire, partner or license product candidates, complete clinical development and, if we are successful, to commercialize any of our current or future product candidates. If the FDA, or any other comparable regulatory agency, such as the EMA, requires that we perform studies or trials in addition to those that we currently anticipate with respect to the development of our current or future product candidates, or repeat studies or trials, our expenses would further increase beyond what we currently expect, and any delay resulting from such further or repeat studies or trials could also result in the need for additional financing and other resources.
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Our existing financial investments and cash and cash equivalents may not be sufficient for us to complete advanced clinical development of our current or future product candidates or, if applicable, to commercialize any product candidates that would be approved. Accordingly, we may continue to require substantial additional capital to continue our clinical development activities and potentially engage in commercialization activities. Because successful development of our current or future product candidates is uncertain, we are unable to estimate the actual funds and resources we will require to complete R&D and commercialize our product candidates. The amount and timing of our future funding requirements will depend on many factors, including but not limited to:
● the progress, costs, results of and timing of our ongoing and planned clinical trials;
● our ability to reach milestones under our existing collaboration arrangements and enter into additional collaborative agreements for the development and commercialization of our product candidates;
● the willingness of the FDA, EMA, the MHRA, the MHLW/PMDA, and other comparable regulatory authorities to accept our clinical trials and preclinical studies and other work as the basis for review and approval of product candidates;
● the outcome, costs and timing of seeking and obtaining regulatory approvals from the FDA, EMA, the MHRA, the MHLW/PMDA, and other comparable regulatory authorities;
● whether our collaboration partners continue to collaborate with us on the development and commercialization of our product candidates;
● the number of product candidates and indications that we pursue, whether developed internally or in-licensed;
● the timing and costs associated with manufacturing our product candidates for clinical trials and other studies and, if approved, for commercial sale;
● our need to expand our development activities and, potentially, our research activities;
● the timing and costs associated with establishing sales and marketing capabilities;
● the costs associated with our future product sales, marketing, commercial manufacturing and distribution activities;
● market acceptance of any approved product candidates;
● the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
● the cost to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
● the extent to which we may be required to pay milestone or other payments under our in-license agreements and the timing of such payments;
● our need and ability to hire additional management, development and scientific personnel; and
● our need to implement additional internal systems and infrastructure, including financial and reporting systems.
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Some of these factors are outside of our control. Based upon our current expected level of operating expenditures and our existing financial investments and cash and cash equivalents, we believe that we will be able to fund our operating expenses and capital expenditure requirements for the coming years. This period could be shortened, but not below a period of 12 months, if there are any significant increases beyond our expectations in spending on development programs or more rapid progress of development programs than anticipated. Accordingly, we expect that we could need to raise additional funds in the future. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to obtain funding from equity offerings or debt financings, including on a timely basis, we may be required to:
● seek additional collaboration partners for one or more of any future proprietary product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;
● relinquish or license on unfavorable terms our rights to technologies or any future proprietary product candidates that we otherwise would seek to develop or commercialize ourselves;
● significantly curtail one or more of our research or development programs;
● curtail our product sales, marketing and/or commercial manufacturing; and
● cease operations altogether.
Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our product candidates or technologies.
We may seek additional funding through a combination of equity offerings, debt financings, collaborations and/or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, shareholders’ ownership interest may be diluted, and the terms may include liquidation or other preferences that adversely affect shareholders’ rights as a holder of the ADSs or our ordinary shares. The incurrence of indebtedness and/or the issuance of certain equity securities could result in increased fixed payment obligations and could also result in certain additional restrictive covenants, such as limitations on our ability to incur additional debt and/or issue additional equity, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. In addition, issuance of additional equity securities, or the possibility of such issuance, may cause the market price of the ADSs or our ordinary shares to decline. In the event that we enter into collaborations and/or licensing arrangements in order to raise capital, we may be required to accept unfavorable terms, including relinquishing or licensing to a third party on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves or potentially reserve for future potential arrangements when we might be able to achieve more favorable terms.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations, financial condition and results of operations.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past, and may in the future lead to market-wide liquidity problems.
If any financial institution with which we have banking relationships were to be placed into receivership or a similar proceeding, we may be unable to access such funds. In addition, if any of our critical vendors, suppliers, manufacturers or other third parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to perform their obligations under arrangements or agreements with us could be adversely affected.
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Although we assess our banking relationships as we believe necessary or appropriate, our access to funding sources in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have arrangements directly, or the financial services industry or economy in general. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry. These factors could involve financial institutions or financial services industry companies with which we have financial or business relationships, but could also include factors involving financial markets or the financial services industry generally.
In addition, investor concerns regarding the United States or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of U.S. federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations, financial condition and results of operations.
In addition, any further deterioration in the macroeconomic economy or financial services industry could lead to losses or defaults by our critical vendors, suppliers, manufacturers or other third parties, which, in turn, could have a material adverse effect on our current and/or projected business operations, financial condition and results of operations.
Risks related to our business development strategy
Our corporate transformation, including our pipeline prioritization efforts and the potential associated headcount reduction, may not be successful and may not yield the desired results.
Due to our limited resources, as well as the depth and breadth of our portfolio, we assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others, or to divest or wind down certain programs. In 2025, as part of a strategic transformation of our Company, we determined to focus on strategic business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition, partnering or licensing of product candidates that we believe to have commercial potential. As part of such strategic transformation, we appointed new members to our senior management and Board of Directors with experience and expertise in business development, and engaged in a review of strategic alternatives for our cell therapy business, including a potential divestiture. In October 2025, after considering all available options, we announced our intention to wind down our cell therapy activities, which was subject to the conclusion of consultations with works councils in Belgium and the Netherlands. Following completion of the works council processes in Belgium and the Netherlands, our Board of Directors announced in January 2026 its decision to initiate the wind-down of our cell therapy activities, which is expected to be substantially completed by the end of the third quarter of 2026. As a result, we are exiting the cell therapy space, which impacts approximately 365 employees across Europe, the United States and China, and which results in the closure of our sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China).
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We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our transformation efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the strategic transformation, our operating results and financial condition would be adversely affected. Furthermore, our strategic transformation may be disruptive to our operations. For example, our pipeline prioritization decisions have, and in the future would, reduce the breadth and diversity of our portfolio and investments therein, potentially limit the long-term growth of our pipeline, and increase the risk and extent of the negative impact on our business if such programs are not successful. Moreover, any divestitures of our product candidates involve risks, including difficulties in the separation of operations, intellectual property and personnel, the diversion of management’s attention, the disruption of our business, the potential loss of key employees and the retention of uncertain environmental or other contingent liabilities related to the divested business. We may also experience unfavorable reactions to the divestitures by competitors, suppliers and employees, making it more difficult to maintain business and operational relationships. Some divestitures are or may be dilutive to earnings, and we may not be successful in executing restructurings and other actions to minimize or offset dilution. We may also fail to successfully complete divestitures or achieve the strategic objectives of divestitures or not realize such objectives within the expected time frame. In addition, divestitures may result in significant asset impairment charges, including those related to goodwill and other intangible assets, which could have a material adverse effect on our financial condition and results of operations. In the event we are unable to successfully divest a business or program, we may be forced to wind down such business or program, which could materially and adversely affect our results of operations and financial condition. We cannot provide assurance as to whether we will be successful in managing these or any other significant risks that we encounter in divesting a business or program, and any divestiture we undertake could materially and adversely affect our business, financial condition, results of operations and cash flows, and may also result in a diversion of management attention, operational difficulties and losses.
Furthermore, the wind-down of our cell therapy activities and related workforce reduction could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, including retention of our remaining employees. Employee litigation related to the workforce reduction could be costly and prevent management from fully concentrating on the business. Our workforce reduction activities may also yield unintended consequences, such as attrition beyond our reduction in workforce and reduced employee morale, which may cause remaining employees to seek alternative employment. Our ability to successfully complete one or more strategic transactions depends in part on our ability to retain certain of our remaining personnel, including members of our senior management. If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of strategic transactions as well as our ongoing business operations and overall business strategy.
If we are not successful in setting forth a new strategic path for our Company, or if our plans are not executed in a timely fashion, this may cause reputational harm with our shareholders and the value of our securities may be adversely impacted. In addition, speculation regarding any developments related to our business strategy or any strategic transaction and perceived uncertainties related to the future of our Company could cause our share price to fluctuate significantly.
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The wind-down of our cell therapy activities is subject to various risks and uncertainties and may not be completed in a timely manner on terms favorable to us, or at all.
In October 2025, we announced our intention to wind down our cell therapy activities and pursue new transformational business development transactions with our available cash resources. This intention to wind down follows a comprehensive review of strategic alternatives, including a potential divestiture, and was subject to the completion of the works council processes in Belgium and the Netherlands.
The plan enables us to enhance operational efficiencies and focus on utilizing our available cash to execute our strategy of building a pipeline of novel therapeutics through strategic business development transactions under the leadership of our new management team.
In January 2026, following the completion of the works council processes, our Board of Directors announced its decision to initiate the wind-down of our cell therapy activities, which is expected to be substantially completed by the end of the third quarter of 2026.
We expect to generate minimal to no revenue until such time that we obtain regulatory approval and commercialize our existing or future product candidates, other than potential earn-out payments from Alfasigma in connection with the transfer of the Jyseleca® business. Following the completion of the wind-down of our cell therapy activities and until such time, if ever, as we are able to acquire, partner, license or develop additional product candidates, our only product candidate in development will be GLPG3667. As a result, we will be substantially dependent on the success of GLPG3667, and our results of operations and financial condition will be increasingly vulnerable to adverse developments in the clinical development and, if approved, commercialization of GLPG3667. Further for reasons unrelated to its clinical development, we may determine to discontinue the development of GLPG3667 at any time, which could leave us without any viable product candidates.
In addition, because of uncertainties with respect to the wind-down our cell therapy activities (including those described above), we may not be able to realize the anticipated benefits of such wind-down, or any benefits at all, or complete the wind-down in the timeframe, on the terms or in the manner we expect, and the costs incurred in connection with such wind-down may exceed our estimates. If the time to complete the wind-down takes longer than expected, if we effect the wind-down on terms or in a manner less favorable to us than currently anticipated or if the actual costs or other non-cash charges exceed our estimates, then our business, operational results, financial position and cash flows could be adversely affected. The wind-down of our cell therapy activities may also adversely affect our relationships with contract development and manufacturing organizations (“CDMOs”), strategic collaborators and partners, as well as our operating results and business generally. If the wind-down process is delayed or not completed for any reason, investor confidence may decline, and we may face negative publicity, investigations by regulatory agencies or other similar authorities, and possible litigation by our investors, employees, service providers, collaboration partners or other potentially impacted parties.
We expended significant management resources in an effort to seek strategic alternatives for the cell therapy business leading up to our intention to wind down our cell therapy activities and have incurred significant costs as part of such efforts, as described in “Item 5 - Operating and financial review and prospects” for the fiscal year ended December 31, 2025. Failure to complete the wind-down could also result in diversion of significant management time and attention to the strategic future of the cell therapy business from other businesses and overall company strategy.
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We may be unsuccessful in identifying and implementing any strategic transaction. Even if we successfully consummate a strategic transaction, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected or we may encounter integration difficulties.
In 2025, as part of a strategic transformation of our Company, we determined to focus on transformational business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition, partnering, or licensing of product candidates that we believe to have commercial potential. We expect to devote substantial time and resources to exploring strategic transactions that our Board of Directors believes will maximize shareholder value. Despite devoting significant efforts to identify and evaluate potential strategic transactions, there can be no assurance that this process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. Since the announcement of our strategic transformation, we have not yet identified or implemented any strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction or series of transactions, will be pursued, successfully consummated or lead to increased shareholder value.
The process of continuing to evaluate these strategic transactions may be very costly, time-consuming and complex, and we have incurred, and may in the future incur, significant costs related to this continued evaluation, such as legal and accounting fees and expenses and other related charges. We may also incur additional unanticipated expenses in connection with this process. A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed. Any such expenses will decrease the remaining cash available for use in our business.
Any future transactions may pose regulatory, antitrust, integration, tax and other risks. Any of these factors may significantly affect the benefits or anticipated benefits of such transactions and consequently our results of operations. Furthermore, any such transactions will require significant management time and resources and may require the diversion of resources from other activities. There can be no assurance that we will identify or successfully complete transactions with suitable candidates in the future, that we will consummate these transactions at rates similar to the past or that completed transactions will be successful. Strategic transactions may involve operational or other changes, significant cash expenditures, debt incurrence, assumed or retained liabilities, operating losses and expenses that could have a material adverse effect on our business, financial condition, results of operations and cash flows. Moreover, actual, potential, or perceived conflicts of interest between our management, Directors and shareholders (including Gilead) may hinder our ability to consummate a transaction. We may not realize the degree, or timing, of benefits we anticipate when we first enter into a transaction.
We may be unable to manage past or future acquisitions profitably or to integrate such acquisitions successfully without incurring substantial costs, delays or other problems. The difficulties of combining the operations of acquired businesses and other risks related to strategic transactions include, among others, the following:
● we may have difficulties in managing the expanded operations of a larger and more complex company, such as the exposure to new or unfamiliar geographies and/or regulatory regimes, which may result in weaknesses in our infrastructure and operations, risks that we may not be able to comply with legal and regulatory requirements and loss of additional employees and reduced productivity among remaining employees;
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● any acquired business, product candidate, program or product could underperform relative to our expectations and the price that we paid for it or not perform in accordance with our anticipated timetable;
● we may incur or assume significant debt in connection with our acquisitions or strategic relationships;
● acquisitions or strategic relationships could cause our financial results to differ from our own or the investment community’s expectations in any given period or over the long-term;
● acquisitions or strategic relationships could create demands on our management, operational resources and financial and internal control systems that we are unable to effectively address;
● we could experience difficulty in identifying, recruiting, maintaining and integrating personnel, operations and financial and other controls and systems and retaining key employees;
● we may be unable to achieve cost savings or other synergies anticipated in connection with an acquisition or strategic relationship;
● we may be exposed to litigation or regulatory, tax or other sanctions, civil or criminal penalties or negative consequences such as license revocation or reputational damage, and indemnifications received from sellers may be insufficient or unavailable for such consequences;
● we may assume by acquisition or strategic relationship unknown liabilities, known contingent liabilities that become realized, known liabilities that prove greater than anticipated, internal control deficiencies or exposure to regulatory sanctions resulting from the acquired company’s activities, the realization of which may increase our expenses, adversely affect our financial position or cause us to fail to meet our public financial reporting obligations;
● in connection with acquisitions, we may enter into post-closing financial arrangements such as purchase price adjustments, earn-out obligations and indemnification obligations, which may have unpredictable financial results;
● we may record significant goodwill and other intangible assets on our balance sheet, and if we are not able to realize the value of these assets, we may be required to incur charges relating to the impairment of these assets; and
● we may have interests that diverge from those of strategic partners and we may not be able to direct the management and operations of the strategic relationship in the manner we believe is most appropriate, exposing us to additional risk.
Many of these factors will be outside our control and any one of them could result in increased costs, decreases in the amount of expected revenues and diversion of management’s time and energy, which could have a material adverse effect on our business, financial condition and results of operations. Although our management will endeavor to evaluate the risks inherent in any particular transaction, we cannot make assurances that we will adequately ascertain or assess all of the significant risk factors.
In addition, any businesses or product candidates we acquire or invest in may not achieve levels of profitability or revenue that justify the original investment made by us. The occurrence of any such events could have a material adverse effect on our business, financial condition and results of operations. Although we have identified general criteria and guidelines for evaluating prospective product candidates for our initial strategic transactions, it is possible that a product candidate for our initial strategic transactions will not satisfy all of these criteria and guidelines. If we complete a strategic transaction for a product candidate that does not meet some or all of these criteria and guidelines, such transaction may not be as successful as a transaction involving a product candidate that does meet all of our general criteria and guidelines. Moreover, our planned workforce reduction may negatively impact our existing clinical, regulatory, operations, support and commercial functions, which could have a negative impact on our ability to successfully develop and, if approved, commercialize any product candidates we acquire or develop. Our future financial performance and our ability to develop any product candidates will depend, in part, on our ability to effectively manage any future growth.
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We have evaluated, and will continue to evaluate, multiple strategic transactions at any given time and may also attempt to simultaneously complete multiple transactions, which may hinder our ability to complete any one transaction and give rise to increased costs and risks that could negatively impact our operations and profitability. If we determine to simultaneously acquire, license or otherwise invest in several businesses or product candidates that are owned by different parties, we could also face additional risks, including additional burdens and costs with respect to possible multiple negotiations and due diligence (if there are multiple sellers) and the additional risks associated with the subsequent assimilation of the operations and services or products of the acquired companies in a single operating business. If we are unable to adequately address these risks, it could negatively impact our profitability and results of operations.
Our business strategy depends upon our ability to negotiate amended terms of our OLCA with Gilead, and there can be no assurance that we will be able to successfully negotiate amended terms to this arrangement.
In 2025, as part of a strategic transformation of our Company, we determined to focus on strategic business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition of product candidates that we believe to have commercial potential. However, our ability to do so may be limited given the scale of the OLCA, the ten-year global R&D collaboration that we entered into with Gilead in July 2019. In particular, we have granted Gilead certain opt-in rights if we obtain a license to additional product candidates as the result of any license or acquisition from, merger with or any other transaction. Although Gilead has expressed willingness to renegotiate these terms and collaborate on any such transaction, there can be no assurance that we will be able to do so on terms favorable to us, or at all. Moreover, we may be unable to manage or integrate such acquisitions successfully due to the additional complexities inherent in a tripartite transaction, and we may be exposed to additional risks or complexities as a result of Gilead’s participation in any transaction, including litigation, antitrust and other regulatory approvals. Any Gilead-partnered transaction will be subject to the same risks as those applicable to our OLCA with Gilead. In particular, we may have interests that diverge from those of Gilead’s, and we may not be able to direct the collaboration in the manner we believe is most appropriate, exposing us to additional risk. For more information, see “—Risks related to our reliance on third parties—We are heavily dependent upon our collaboration arrangements with Gilead and certain other third parties for the development and commercialization of our products and there can be no assurance that these arrangements will deliver the benefits we expect.”
If Gilead declines to collaborate with us on a transaction and we are otherwise unable to identify a collaboration partner for the licensed or acquired product candidates, we may be unable to advance the development of such product candidates through clinical development and seek approval in any market. In situations where we enter into a development and commercial collaboration arrangement for a product candidate, we may also seek to establish additional collaborations for development and commercialization in territories outside of those addressed by the first collaboration arrangement for such product candidate. If any of our product candidates receives marketing approval, we may enter into sales and marketing arrangements with third parties with respect to otherwise unlicensed or unaddressed territories. Furthermore, there are a limited number of potential collaboration partners, and we expect to face competition in seeking appropriate collaboration partners. If we are unable to enter into any development and commercial collaborations and/or sales and marketing arrangements on acceptable terms, or at all, we may be unable to successfully develop and seek regulatory approval for our product candidates and/or effectively market and sell approved products, if any.
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Because of our limited resources, we face significant competition for strategic transaction opportunities, and it may be more difficult for us than for our competitors to complete any strategic transaction.
Competition for strategic transactions in the biopharmaceutical industry has escalated during recent years, and such competition may increase costs of such transactions or cause us to refrain from entering into certain such transactions. In particular, we expect to encounter competition from other entities having a business objective similar to ours, including private investors (which may be individuals or investment partnerships), blank check companies and other entities, domestic and international, competing for the types of businesses or product candidates we intend to acquire, particularly large, fully integrated, well-established pharmaceutical companies who already possess a large share of the market. Many of these competitors are well-established and have extensive experience in identifying and effecting, directly or indirectly, acquisitions of businesses or product candidates. Many of these competitors also possess similar or greater technical, human and other resources to ours or more local industry knowledge than we do, and our financial resources will be relatively limited when contrasted with those of many of these competitors. Mergers and acquisitions in the biopharmaceutical industry could result in even more resources being concentrated among a small number of our competitors. Our ability to compete with respect to the acquisition of certain businesses or product candidates that are sizable will be limited by our available financial resources and, if we and Gilead determine to collaborate on an acquisition, Gilead’s available financial resources. This inherent competitive limitation gives others an advantage in pursuing the acquisition of certain businesses or product candidates.
Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction and further develop and, if approved, commercialize any product candidate acquired in such transaction.
Our ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction, the loss of whose services may adversely impact the ability to consummate such transaction. In 2025, as part of a strategic transformation of our Company, we determined to focus on strategic business development transactions and have adjusted our pipeline prioritization strategy and resource allocation in order to enable the acquisition of product candidates that we believe to have commercial potential. As part of such strategic transformation, we appointed new members to our senior management and Board of Directors with experience and expertise in business development, and engaged in a review of strategic alternatives for our cell therapy business, among other things. In January 2026, following the completion of the works council process, our Board of Directors announced its decision to initiate the wind-down of our cell therapy activities, which is expected to be substantially completed by the end of the third quarter of 2026. The wind-down will impact approximately 365 employees. Our cash conservation activities may yield unintended consequences, such as attrition beyond our planned reduction in workforce and reduced employee morale, which may cause remaining employees to seek alternative employment.
Our ability to successfully complete one or more strategic transactions depends in part on our ability to retain certain of our remaining personnel, including members of our senior management, as well as our ability to hire additional personnel as required to support the development and, if approved, commercialization of any product candidate we acquire, license or otherwise invest in. In particular, we may consider a strategic transaction outside of our existing management or employees’ area of expertise if we determine that a particular product candidate offers an attractive acquisition opportunity for our Company. If we are unable to successfully retain our remaining personnel or hire additional personnel as required, we are at risk of a disruption to our exploration and consummation of strategic transactions, as well as our ongoing business operations and overall business strategy.
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We are substantially dependent on the successful implementation of our business development strategy to acquire, license or otherwise invest in product candidates and on the eventual approval and commercialization of such product candidates.
We expect to generate minimal to no revenue until such time that we are able to obtain regulatory approval of and commercialize our existing or future product candidates, other than earn-out payments from Alfasigma in connection with the transfer of the Jyseleca® business. Following the wind-down of our cell therapy activities and until such time, if ever, as we are able to acquire, partner or license or develop additional product candidates, our only product candidate in development will be GLPG3667. As such, our success significantly depends on our ability to implement our business development strategy and enter into strategic transactions to acquire, license or otherwise invest in product candidates. Our strategy further depends on the eventual progression of such product candidates into later-stage clinical trials and commercialization. In some cases, such as certain Gilead-partnered transactions, we may not fully control the progression, clinical development, regulatory strategy or eventual commercialization, if approved, of such product candidates. In such cases, our future success and the potential to obtain approval and commercialization of any product candidates are significantly dependent on such third parties’ efforts, over which we have little control. In addition, we may not control the timing of disclosures by such third parties of any information related to such product candidates. Any disclosure by us or third parties of data or other information regarding any such product candidates that is perceived as negative may have a material adverse impact on our share price or overall valuation. Our share price may also decline as a result of negative results from any eventual clinical trial, including adverse safety events, involving any product candidate that is subject to one of our partnerships.
Moreover, therapeutic development is inherently uncertain and very few product candidates ultimately progress through clinical development and receive approval for commercialization. See the section titled “—Risks related to product development and regulatory approval” for additional information related to the risks of drug development. If we or our partners do not receive regulatory approval for a sufficient number of product candidates, we may not be able to sustain our business model or strategy.
Risks related to product development and regulatory approval
Following the wind-down of our cell therapy activities and until such time, if ever, as we are able to acquire, partner, or license or develop additional product candidates, we will be substantially dependent on the success of our only investigational product candidate, GLPG3667. We cannot give any assurance that any product candidate will successfully complete clinical trials or receive regulatory approval, both of which are necessary before such product can be commercialized.
Our business and future success are substantially dependent on our ability to develop successfully, obtain regulatory approval for and then successfully commercialize our clinical-stage product candidates, including GLPG3667 and any potential future product candidates we acquire, partner or license through business development transactions. Further, for reasons unrelated to its clinical development, we may determine to discontinue the development of GLPG3667 at any time, which could leave us without any viable product candidates.
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Our product candidates will require additional clinical development, management of clinical and manufacturing activities, regulatory approvals in multiple jurisdictions (if such regulatory approvals can be obtained at all), securing sources of commercial manufacturing supply, building of, or partnering with, commercial organizations, substantial investments and significant marketing, sales and distribution efforts before any revenues can be generated from product sales. We are not permitted to market or promote any of our product candidates before we receive the relevant regulatory approvals from the FDA, the European Commission (the “EC”), the MHRA or any other comparable regulatory authority such as the MHLW/the PMDA, and we may never receive such regulatory approvals for any of our product candidates. We cannot make assurances that our clinical trials for GLPG3667 or any future product candidates will be completed in a timely manner, or at all, or that we will be able to obtain approval from the FDA, the EC, the MHRA, the MHLW/PMDA, or any other comparable regulatory authority for any of these product candidates. As part of our ongoing efforts to maximize the value for both patients and ourselves of our sole remaining small molecule development program from our legacy discovery platform, GLPG3667, which is being evaluated in two Phase 2 studies in DM and SLE, we are evaluating all strategic options for GLPG3667. These include exploring a potential partnership and business development opportunities to accelerate development of GLPG3667 in DM, as well as in parallel assessing the funding and capability requirements for us to run our own Phase 3 program for GLPG3667 in DM. Further, we cannot be certain that we will advance any other product candidates into clinical trials. If GLPG3667, or any future product candidate, is not approved and commercialized, we will not be able to generate any product revenues for that product candidate. Moreover, any delay or setback in the development of any product candidate could adversely affect our business and cause the price of the ADSs, or our ordinary shares to fall.
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Due to our limited resources and access to capital, we have prioritized the development of certain product candidates and may have forgone the opportunity to capitalize on product candidates or indications that may ultimately have been more profitable or for which there was a greater likelihood of success.
Due to our limited resources, we have in the past been required to prioritize the development of product candidates over others. As of year-end 2022, we implemented a new innovation R&D focusing on the therapeutic areas of oncology and immunology. Following a strategic review announced in August 2023, we transferred the commercial, medical affairs and development activities regarding filgotinib (which is marketed as Jyseleca® in the European Union, United Kingdom and Japan) to Alfasigma S.p.A, or Alfasigma, in January 2024. In January 2025, we announced our intention to separate into two publicly traded entities: a newly to be formed company (to be named at a later date, herein “SpinCo”), which would focus on building a pipeline of innovative medicines through transformational transactions, and us. As announced on January 8, 2025, we discontinued our small molecule discovery programs and searched for potential partners to take over our small molecules’ discovery assets. In addition, as part of our ongoing efforts to maximize the value for both patients and ourselves, we are evaluating all strategic options for GLPG3667, our sole remaining small molecule development program from our legacy discovery platform. Additionally, we continue to explore opportunities to expand into other severe autoimmune diseases with significant unmet medical need. In addition, on October 21, 2025, we announced our intention to wind down our cell therapy activities and pursue new transformational business development transactions using our available cash resources. This intention was subject to completing the works council processes in Belgium and the Netherlands. Subsequently, in January 2026, following completion of the works council processes, our Board of Directors announced its decision to initiate the wind-down of our cell therapy activities. This will enable us to enhance operational efficiency and focus on deploying our available cash to execute our strategy of building a pipeline of novel therapeutics through strategic business development transactions, under the leadership of our new management team. Our decisions concerning the allocation of research, collaboration, management, commercial and financial resources toward particular compounds, products or product candidates or therapeutic areas may not lead to the development of additional viable commercial products, we may forgo or delay the pursuit of opportunities with other product candidates or for other indications that may prove to have greater commercial potential. Similarly, our potential decisions to delay, terminate or collaborate with third parties in respect of certain product development programs may also prove not to be optimal and could cause us to miss valuable opportunities. Accordingly, there can be no assurance that we will ever be able to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, which could adversely affect our future growth and prospects. If we make incorrect determinations regarding the market potential of our products or product candidates or misread trends in the pharmaceutical industry, our business, financial condition and results of operations could be materially adversely affected.
The regulatory approval processes of the FDA, the EMA, the MHRA, the MHLW/PMDA and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable which may affect the commercial viability of our products or product candidates in development. If we are ultimately unable to obtain regulatory approval for our products or product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA, the EMA, the MHRA, the MHLW/PMDA and any other comparable regulatory authority is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Although we and Gilead have received regulatory approval for filgotinib (which has been transferred to Alfasigma in 2024) in the European Union, Great Britain, and Japan for the treatment of RA and UC, it is possible that none of our other existing product candidates or any potential product candidates that we may seek to develop in the future will ever obtain regulatory approval.
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Our product candidates could fail to receive regulatory approval for many reasons, including the following:
● the FDA, the EMA, the MHRA, the MHLW/PMDA or any other comparable regulatory authority may disagree with the design or implementation of our clinical trials;
● we may be unable to demonstrate to the satisfaction of the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authorities that a product candidate is safe and effective for its proposed indication;
● the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authorities for approval;
● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh such product’s safety risks;
● should we resume development of our cell therapy product candidates, a number of our next generation cell therapy product candidates would be novel mode of action compounds, which may carry additional risk regarding the desired level of efficacy and their safety profiles;
● the FDA, the EMA, the MHRA, the MHLW/PMDA or any other comparable regulatory authority may disagree with our interpretation of data from preclinical studies or clinical trials;
● the data collected from the trials of our product candidates may not be sufficient to support the submissions of new drug applications (“NDAs”), supplemental NDAs, biologics license applications (“BLAs”), or other submissions or to obtain regulatory approval in the United States, Europe or elsewhere;
● the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authorities may find deficiencies with or fail to provide approvals for our manufacturing processes or facilities or processes of third-party manufacturers with which we contract for clinical and commercial supplies or such facilities or processes may not pass pre-approval inspections; and
● the approval policies or regulations of the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authorities may change or differ from one another significantly in a manner rendering our clinical data insufficient to obtain all the necessary approvals. For example, proposed amendments to the European Union directives and regulations related to pharmaceutical product development and marketing have been agreed by the European Parliament and the Council of the European Union, which, if adopted, will replace the current European Union regulatory framework for medicines.
This lengthy approval process as well as the unpredictability of future clinical trial results, may result in our and our (potential future) collaboration partners’ failure to obtain regulatory approval to market GLPG3667 and/or other product candidates, which would harm our business, results of operations and prospects significantly. In addition, even if we were to obtain additional approvals, regulatory authorities may approve any of our products or product candidates for fewer or more limited indications or patient populations than we request, may grant approvals contingent on the performances of costly post-marketing clinical trials or may approve a product or product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. In certain jurisdictions, regulatory authorities may not approve the price we intend to charge for our products. Any of the foregoing scenarios could materially harm the commercial prospects for our products or product candidates.
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Additionally, in the past and for future planned clinical trials, we may utilize, an “open-label” trial design. In an open-label trial, both investigators and trial participants are fully aware of which treatment group the participants are in and what treatments are assigned to them. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving the experimental treatment; thus open-label clinical trials may be subject to a “patient bias,” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open- label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received the experimental treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results for any of our product candidates when they are later studied in controlled environments with placebos or active controls.
In addition, we cannot guarantee that the FDA, the EMA, the MHRA, the MHLW/PMDA or any other comparable regulatory authority will interpret the results of any of our ongoing or planned clinical trials as we do, and additional clinical trials beyond those we anticipate conducting could be required before we can submit our product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA, the EMA, the MHRA, the MHLW/PMDA or any comparable regulatory authorities for the purpose of providing support for marketing applications, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potentially gaining the necessary regulatory approvals for our product candidates.
We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approvals even if they are successful in clinical trials. If we do not receive regulatory approval for our product candidates, we may not be able to continue our operations. If the markets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products or product candidates, if approved.
Furthermore, the United States Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely, and potentially materially, impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation, administrative action or legal challenges, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or to the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, our business could be materially harmed.
Interim, topline or preliminary data from any preclinical studies or clinical trials that we conduct may change as more data become available and is subject to audit and verification procedures that could result in material changes in the final data.
Some of our trials are designed as open-label trials. From time to time, we may publicly disclose interim, preliminary or topline data from our clinical trials, including safety data and evaluations of efficacy, which will be based on a preliminary analysis of then-available data from a defined data cut-off date, and the results and related findings and conclusions are subject to change following our receipt of additional data or a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data.
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As a result, the preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data has been received and fully evaluated. Preliminary data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary data should be viewed with caution until the final data is available. From time to time, we may also disclose interim data from planned interim analyses in our clinical trials. Interim data from clinical trials that we may complete is subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data becomes available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by us or our competitors, or by patients or caregivers who are aware that a patient is receiving an investigational product due to the open-label design of the trial, could result in volatility in the price of our common stock.
Regulatory agencies, including the FDA, the EMA, the MHRA, the MHLW/PMDA or any other foreign regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our Company in general.
If the interim or preliminary data that we report differ from actual final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
In connection with our global clinical trials, local regulatory authorities may have differing perspectives on clinical protocols and safety parameters, which impacts the manner in which we conduct these global clinical trials and could negatively impact our chances for obtaining regulatory approvals or marketing authorization in these jurisdictions, or for obtaining the requested label or dosage for our product candidates, if regulatory approvals or marketing authorizations are obtained.
In connection with our global clinical trials, we are obligated to comply with the requirements of local regulatory authorities in each jurisdiction where we execute and locate a clinical trial. Although the FDA, EMA or any comparable foreign regulatory authorities may accept data from clinical trials conducted outside the relevant jurisdiction, acceptance of this data is subject to certain conditions. Local regulatory authorities can request specific changes to the clinical trial protocol or specific safety measures that differ from the positions taken in other jurisdictions. For example, the FDA requires that the clinical trial must be well- designed and conducted and performed by qualified investigators in accordance with ethical principles such as institutional review board or ethics committee approval and informed consent, an adequately representation of the United States population in the trial population and data that is applicable to the United States population and United States medical practice in ways that the FDA deems clinically meaningful. Further, the FDA may consider an on-site inspection to be necessary in which case they must be able to validate the data through such an inspection or other appropriate means. Additionally, recent policy proposals in the U.S., if enacted in the future, may make acceptance by the FDA or inclusion in a marketing application of foreign data more difficult or costly. Further, while these clinical trials are subject to the applicable local laws, acceptance of the data by the FDA will depend upon its determination that the trials were conducted consistent with all applicable United States laws and regulations. Similarly, any data submitted to foreign regulatory authorities may not adhere to their standards and requirements for clinical trials and data from trials conducted outside of such jurisdiction may not be accepted.
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The FDA or any other regulatory authorities may approve different labels, including for whom the drug is indicated or require different warnings or precaution, or impose dosing restrictions that differ from the approved dosing regimen in other jurisdictions, and these differences could have a material adverse effect on our ability to commercialize our products in these jurisdictions. There can be no assurance that the FDA, the EMA, the MHRA, the MHLW/PMDA or any other comparable regulatory authority will accept data from trials conducted outside of their jurisdictions as adequate support for marketing applications. If the FDA, EMA, MHRA, the MHLW/PMDA or any comparable foreign regulatory authorities do not accept such data, we might need to conduct additional trials, which could be costly and time-consuming, and which could result in our potential future product candidates not receiving approval for commercialization in the applicable jurisdictions. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted, which may increase costs or time required to complete the clinical trials. Regulatory authorities could also not approve our applications, which would adversely affect our business prospects and ability to achieve or sustain profitability.
Conducting multinational clinical trials exposes us to additional risks, including but not limited to risks associated with:
• additional foreign regulatory requirements;
• foreign exchange fluctuations;
• compliance with foreign manufacturing, customs, shipment and storage requirements;
• inconsistent standards for reporting and evaluating clinical data and adverse events;
• varying standards or availability of care, resulting in data that may differ from patients who have received the standard of care therapy;
• any pandemic, epidemic or public health emergencies;
• diminished protection of intellectual property in some countries; and
•political instability, civil unrest, war or similar events that may jeopardize our ability to commence, conduct or complete a clinical trial and evaluate resulting data.
Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product, and we may be required to include labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings.
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If the FDA, the EMA, the EC, the MHRA, the MHLW/PMDA or any other comparable regulatory authorities approve any of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for those products will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration requirements and continued compliance with current good manufacturing practices (“cGMPs”), and good clinical practices (“GCPs”), for any clinical trials that we conduct post-approval. Manufacturers and other parties involved in the drug supply chain for prescription drug and biological products must also comply with product tracking, tracing and notification requirements, including notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, involving our third-party manufacturers or manufacturing processes or concerning our failure to comply with regulatory requirements, may result in, among other things:
● restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
● fines, untitled or warning letters or holds on clinical trials;
● imposition by the FDA, the EMA, the MHLW/PMDA, or any other comparable regulatory authorities of more restrictive labeling, including label updates and adjustments;
● refusal by the FDA, the EMA, the MHLW/PMDA, or any other comparable regulatory authorities to approve pending applications or supplements to our filed and approved applications;
● or suspension or revocation of product approvals or licenses by the FDA, the EMA, the MHLW/PMDA or any other comparable regulatory authorities;
● product seizures or detentions,
● refusal to permit the import or export of products; and
● injunctions or the imposition of civil or criminal penalties.
The policies of the FDA, the EMA, the MHRA, the MHLW/PMDA, and other comparable regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or to the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
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Clinical development is a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials, as well as data from any interim analyses of ongoing clinical trials, may not be predictive of future trial results or of approvals of labels for clinical use. Clinical failure can occur at any stage of clinical development.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Although product candidates may demonstrate promising results in early clinical (human) trials and preclinical (animal) studies, they may not prove to be effective in subsequent clinical trials. For example (without any limitation), testing on animals may occur under different conditions than testing in humans and therefore the results of animal studies may not accurately predict human experience. Likewise, early clinical studies may not be predictive of eventual safety or effectiveness results in larger-scale pivotal clinical trials. The results of preclinical studies and previous clinical trials as well as data from any interim analysis of ongoing clinical trials of our product candidates, as well as studies and trials of other products with similar mechanisms of action to our product candidates, may not be predictive of the results of ongoing or future clinical trials. For example (without any limitation), the results generated to date in the Phase 2 trials with GLPG3667 do not ensure that later clinical trials, including any post-approval clinical trials for approved products, will continue to demonstrate similar results or observations. Moreover, dose escalation and dose expansion cohort data are required to establish the dose for pivotal trials, and durability of response can only be established based on longer term follow up of patients who received therapy. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profiles despite having progressed through preclinical studies and earlier clinical trials. In addition to the safety and efficacy profiles of any product candidates, clinical trial failures may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, manufacturing and patient enrollment criteria. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials, and it is possible that we will as well.
For example, in February 2023, we announced the topline results from our Phase 3 trial with filgotinib in Crohn’s disease. As the two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10, we decided not to submit a Marketing Authorization Application in the European Union.
Based upon negative or inconclusive results, we or our collaboration partners may decide or regulators may require us, to conduct additional clinical trials or preclinical studies. In addition, data obtained from trials may be susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approvals.
We may experience delays in our ongoing clinical trials and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including but not limited to delays related to:
● obtaining regulatory authorization to commence a trial;
● reaching agreements on acceptable terms with prospective CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
● obtaining Institutional Review Board (“IRB”), or ethics committee approval at each clinical trial site;
● obtaining regulatory concurrence on the design and parameters of the trial;
● obtaining the necessary approvals for the designs of clinical development programs for each country targeted for trial enrollment;
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● recruiting suitable patients to participate in a trial, which may be impacted by the number of competing trials that are enrolling patients;
● having patients complete a trial or return for post-treatment follow-up;
● clinical sites deviating from trial protocol or dropping out of a trial;
● failing to comply with GCP or other regulatory requirements;
● adding new clinical trial sites;
● manufacturing sufficient quantities of product candidate or obtaining sufficient quantities of comparator drugs for use in clinical trials; and
● the availability of adequate financing and other resources.
We could encounter delays if a clinical trial is suspended or terminated by us, our collaboration partners, by the IRBs or ethics committees of the institutions in which such trials are being conducted, or by the FDA, competent authorities of the EU member states, the MHRA, MHLW/PMDA or any other comparable regulatory authorities, or if the Data Monitoring Committee (the “DMC”) recommends such trial’s suspension or termination. A suspension or termination, including in some cases a clinical hold, may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, competent authorities of the EU member states, the MHRA, MHLW/PMDA, or other comparable regulatory authorities, safety issues or adverse side effects, including those seen in the class to which our product candidates belong, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions, manufacturing issues or lack of adequate funding to continue the clinical trial. For example (without limitation), it is possible that safety issues or adverse side effects could be observed in trials for GLPG3667 in immunology, which could result in a delay, suspension or termination of our ongoing trial. If we experience delays in the completion of, or experience a termination of any clinical trials of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed or prevented. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidates’ development and approval processes and jeopardize our ability to start commercialization and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause or lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
If GLPG3667 or any other product candidate is found to be unsafe or would not be efficacious, we will not be able to obtain regulatory approval for it and our business would be materially harmed.
In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial protocols, differences between the levels of adherence to trial protocols like the dosing regimen, differences in composition of the patient populations, and varying dropout rates among the respective clinical trial participants. We do not know whether any Phase 2, Phase 3 or other clinical trials that we or any of our collaboration partners may conduct will demonstrate consistent or adequate efficacy and safety to obtain the regulatory approvals necessary to market our product candidates. If we are unable to bring any of our current or future product candidates to market, our ability to create long-term shareholder value will be limited.
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Changes in the FDA, other government agencies or any other comparable regulatory authority could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA or any other comparable regulatory authority to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. In addition, government funding of other government agencies or any comparable foreign regulatory authority on which our operations may rely, including those that fund R&D activities, is subject to the political process, which is inherently fluid and unpredictable.
Disruptions within the FDA or any other comparable regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by the necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. Average review times at the FDA have fluctuated in recent years as a result. If a prolonged government shutdown occurs, including as a result of reaching the debt ceiling, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, government shutdowns could impact our ability to access the public markets and obtain additional capital in the future.
Our current and future product candidates may require specific shipping, storage, handling and administration at the clinical trial sites, which could subject our product candidates to risk of loss or damage.
Our current and future product candidates may be sensitive to temperature, storage and handling conditions. Such processes are complex and require that the storage, handling and administration of the product or product candidate must be performed according to specific instructions, typically using specific storage and shipping conditions, disposables, specific bags and in some steps, within specific time periods. For example, our decentralized cell therapy platform was designed to allow us to harvest, transport, manufacture and deliver fresh cell therapy product candidates near the cancer treatment centers, in a median vein-to-vein time of seven days. Failure to correctly handle our products and product candidates, including failure to administer our products and product candidates within certain specified time periods, could negatively impact the efficacy and/or safety of our products and product candidates or cause losses of products and product candidates.
If microbial, viral or other contaminations are discovered in any product candidate or manufacturing facility, such manufacturing facility may need to be closed for an extended period of time to allow us to investigate and remedy the contamination. The process of developing products that can be commercialized may be particularly challenging, even if they otherwise prove to be safe and effective.
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The rates at which we complete our scientific studies and clinical trials depend on many factors, including, but not limited to, patient enrollment.
Patient enrollment and enrollment rate are significant factors impacting the duration and completion of clinical trials. These are affected by many factors including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
Furthermore, our efforts to build relationships with patient communities may not succeed, which could result in delays in patient enrollment in our clinical trials. In addition, any negative results we may report in clinical trials of a particular drug candidate may make it difficult, or in some cases, impossible, to recruit and retain patients in other clinical trials involving that same drug candidate. Delays in the completion of any clinical trials of our product candidates will increase our costs, slow down our product candidate development and approval process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause or lead to delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approvals of our product candidates.
We may not be successful in our efforts to use and expand our drug discovery efforts to build a pipeline of product candidates.
We have and may in the future continue to use and expand our drug discovery efforts to build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of a variety of diseases. Although our R&D efforts to date have resulted in a pipeline of product candidates in multiple indications, we may not be able to develop product candidates that are safe and effective. Even if we are successful in continuing to build our pipeline, the potential product candidates that we identify may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be product candidates that will receive marketing approval and achieve market acceptance. If we do not continue to develop our pipeline successfully and are not able to commercialize products, we will face difficulty in generating product revenues in future periods, which could result in significant harm to our financial position and adversely affect the price of the ADSs or our ordinary shares.
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We face significant competition for our drug discovery and development efforts, and if we do not compete effectively, our commercial opportunities will be reduced or eliminated.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. Our drug discovery and development efforts may target diseases and conditions that are already addressed by existing therapies or by product candidates that are being developed by our competitors, many of which have substantially greater resources, larger R&D staffs and facilities, more experience in completing preclinical testing and clinical trials, and more or better formulation, marketing and manufacturing capabilities than we do. As a result of these resources, our competitors may develop drug products that render our products and product candidates obsolete or noncompetitive by developing more effective drugs or by developing their products more efficiently. Our ability to develop competitive products would be limited if our competitors succeed in obtaining regulatory approvals for product candidates more rapidly than we are able to or in obtaining patent protection or other intellectual property rights that limit our drug development efforts. We depend on our management team to develop and successfully implement strategies for us to obtain regulatory approvals for our selected product candidates faster than our competitors and to obtain and maintain patent protections and other intellectual property rights and know-how that protect our drug development efforts. Any drug product resulting from our R&D efforts, or from our joint efforts with collaboration partners or licensees, might not be able to compete successfully with our competitors’ existing and future products, or obtain regulatory approval in the United States, European Union or elsewhere. Further, we may be subject to additional competition from alternative forms of treatment, including generic or over-the-counter drugs.
For example, GLPG3667 faces significant competition in both the fields of DM and SLE. In the field of DM, physical therapy, exercise and medication including corticosteroids, immunosuppressants or immunoglobulin treatment, are typically used to treat DM. Treatment of this disease has relied for many years on off-label medication – however, in 2021 the FDA approved immunoglobulin treatment Octagam® (IVIg), based on the Phase 3 ProDerm trial from Octapharma. In September 2025, brepocitinib (oral JAK1/TYK2; Proviant) met its primary endpoint (Total Improvement Score (TIS) at Week 52) in the Phase 3 VALOR trial, supporting a regulatory filing which is currently planned for early 2026. Additionally, there are a number of Phase 3 compounds (dazukibart (anti-IFN; Pfizer), anifrolumab (Saphnelo®; anti-IFN; AstraZeneca) and efartigimod (Vyvgart®; anti-FcRn; Argenx) which could launch before the end of the decade.
In the field of SLE, corticosteroids, antimalarials and B-Cell modulators are commonly used to control lupus disease activity. Only two products are currently approved to treat SLE, both as add-on to standard therapy: Belimumab (Benlysta®) (anti-BAFF) from GSK and recently anifrolumab (Saphnelo® - both IV and SC formulations) (anti -IFN) from AstraZeneca. There are currently over 10 products in Phase 3 clinical development for SLE, of which the majority are injectable therapies, focusing on advanced disease. There remains a minority of oral therapies, under development – most notably deucravacitinib (SotyktuTM) (TYK2) from BMS, upadacitinib (RinvoqTM ) (JAK) from Abbvie and cenerimod (S1P1) from Idorsia/Viatris.
Many of our competitors have significantly greater financial, technical, and human resources than we have. Mergers and acquisitions in the pharmaceutical, medical device and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunities could be reduced or eliminated if our competitors develop or market products or other novel therapies that are safer, more effective, or less costly than our current or future product candidates, or if any obtain regulatory approval for their products more rapidly than we may obtain approval for our product candidates. Our success will be based in part on our ability to identify, develop and manage a portfolio of product candidates that are safer and more effective than competing products.
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If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively the “ACA”), includes a subtitle called the “Biologics Price Competition and Innovation Act of 2009” (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed under a BLA. During this 12- year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity, and potency of the other company’s product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.
We believe that any of our product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our investigational medicines to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover, the extent to which a biosimilar, once licensed, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
If competitors are able to obtain marketing approval for biosimilars referencing any of our product candidates, our products may become subject to competition from such biosimilars, which would impair our ability to successfully commercialize and generate revenues from sales of such products.
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA, the MHRA, the MHLW/PMDA, or any other comparable regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of certain side effects. In such an event, our trials could be suspended or terminated and the FDA, the EMA, the MHRA, the MHLW/PMDA or any comparable regulatory authorities could order us to cease further development or deny the approval of our product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.
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Additionally, while FDA has removed REMS requirements for approved CAR-T cell therapies and while we have ceased development of our cell therapy product candidates, we are required by the FDA to ensure long-term monitoring of patients who received our cell therapies in prior clinical trials. Undesirable side effects caused by any of our cell therapy product candidates could cause us or regulatory authorities to interrupt, delay or halt preclinical or clinical studies and could result in restrictions on the labeling, distribution, or marketing of any approved products or a requirement to conduct potentially costly post-approval studies or the delay or denial of marketing approval by the FDA or other comparable foreign regulatory authorities. Side effects and toxicities associated with any of our product candidates, if approved, as well as the warnings, precautions, and requirements listed in the prescribing information, could affect the willingness of physicians to prescribe, and patients to use, such product candidates, if approved, and negatively affect market acceptance and commercial sales. In some cases, side effects such as neurotoxicity or cytokine release syndrome have resulted in clinical holds of ongoing clinical trials and/or discontinuation of the development of the product candidate. Results of our studies could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the studies or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.
For example, over the last several years, we have focused on the development of multiple CAR-T product candidates. In previous clinical trials, including those involving cell therapy products and product candidates, patients have experienced side effects such as neurotoxicity (ICANS) and cytokine release syndrome (“CRS”). There were life-threatening events related to severe neurotoxicity and CRS that required intense medical intervention such as intubation or vasopressor support, and in several cases, resulted in death. Severe neurotoxicity is a condition that is currently defined clinically by cerebral edema, confusion, drowsiness, speech impairment, tremors, seizures, or other central nervous system side effects, when such side effects are serious enough to lead to intensive care. In some cases, severe neurotoxicity was thought to be associated with the use of certain lymphodepletion regimens used prior to the administration of the CAR-T products. CRS is a condition that is currently defined clinically by certain symptoms related to the release of cytokines, which can include fever, chills, low blood pressure, and when such side effects are serious enough, they have led to intensive care with mechanical ventilation or significant vasopressor support. The exact cause of CRS and severe neurotoxicity in connection with treatments using CAR-T products is not fully understood at this time. In addition, patients have experienced other adverse events in these studies, such as a reduction in the number of blood cells (in the form of neutropenia, thrombocytopenia, anemia or other cytopenias), febrile neutropenia, chemical laboratory abnormalities (including elevated liver enzymes), and renal failure. In some cases, side effects such as neurotoxicity or CRS have resulted in clinical holds of ongoing clinical trials and/or discontinuation of the development of product candidates. Toxicities resulting from engineered cell therapies are not normally encountered in the general patient population and by medical personnel, and medical personnel may need additional training regarding engineered cell therapies to understand their side effects. Complexity of the potential side effects of engineered cell therapies, associated with the potential presence of comorbidities, could result in deaths. Should we resume our cell therapy activities, any of these occurrences may harm our business, financial condition and prospects significantly.
If one or more of our products or product candidates receive marketing approval, and we or others identify undesirable side effects later caused by such products, a number of potentially significant negative consequences could result, including but not limited to:
● regulatory authorities may withdraw approvals of such product;
● if approved, regulatory authorities may require additional warnings on the label or impose updates to the label, such as a “boxed” warning or a contraindication;
● if approved, regulatory authorities may require a risk evaluation and mitigation strategy (“REMS”) plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools;
● we may be subject to regulatory investigations and government enforcement actions;
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● we could be sued and held liable for harm caused to patients; and
● our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects.
Our clinical trials or those of any of our collaborators may reveal significant adverse events not seen in our preclinical studies or earlier clinical trials and result in safety profiles that could inhibit regulatory approvals or market acceptance of any of our product candidates.
If significant adverse events or other side effects are observed in any of our clinical trials, we may have difficulty recruiting patients to participate in our clinical trials, patients may drop out of our trials, we may be required to pause, delay, or abandon the trials or our development efforts of one or more product candidates altogether, we may be required to have more restrictive labeling, including updates and adjustments of product labels, or we may experience the delay or denial of regulatory approval by the FDA, EMA, MHRA, the MHLW/PMDA, or other applicable regulatory authorities. We, the FDA, other applicable regulatory authorities, or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects.
Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause adverse events or other side effects that prevented their further development. Even if any such adverse events or other side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may still inhibit market acceptance of the approved product due to its perceived tolerability versus the perceived tolerability of other therapies.
Delays in obtaining regulatory approval of manufacturing processes and facilities or disruptions in manufacturing processes may delay or disrupt our commercialization efforts.
Before we can begin to commercially manufacture our product candidates, the FDA, EMA and any other comparable regulatory authority must review the applicable manufacturing process and facilities as part of their review of our marketing application. This will likely require the manufacturing facilities to pass pre-approval inspections by the FDA, EMA and any other regulatory authorities.
In order to obtain approval from the FDA, EMA and any other regulatory authorities, we will need to ensure that all of the processes, methods and equipment are compliant with cGMP and perform extensive audits of vendors, contract laboratories and suppliers. If any of our vendors, contract laboratories or suppliers is found to be out of compliance with cGMP, we may experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation(s) or, if necessary, to identify suitable replacement vendors. The cGMP requirements govern, among other things, quality control of the manufacturing process, raw materials, containers/closures, buildings and facilities, equipment, storage and shipment, labeling, laboratory activities, data integrity, documentation policies and procedures and returns. To comply with cGMP, we will be obligated to expend time, resources and efforts in production, record keeping and quality control to ensure that the product meets applicable specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible regulatory action that could adversely affect our business, results of operations, financial condition and cash flows, including the inability to sell any products that we may develop.
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Risks related to commercialization of future products
The commercial success of any future products will depend upon the degree of market acceptance by physicians, healthcare payers, patients, and the medical community.
The commercial success of any future products that we may develop will depend in part on acceptance by the medical community, patients, and third-party or governmental payers that such products are medically useful, cost-effective, and safe. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenues and may not become profitable. The degree of market acceptance of any future products we may develop will depend on a number of factors, including but not limited to:
● the efficacy and safety, as demonstrated in clinical trials;
● the timing of market introduction of the product, as well as the timing of entry of competitive products;
● the clinical indications for which the product is approved;
● acceptance by physicians, the medical community and patients of the product as a safe and effective treatment;
● the convenience of prescribing and initiating patients to be on the product;
● the potential and perceived advantages of such product over alternative treatments;
● the cost of treatment in relation to alternative treatments, including any similar generic treatments;
● the availability of coverage and adequate reimbursement and pricing by third-party payers and government authorities;
● relative convenience and ease of administration;
● the prevalence and severity of adverse side effects; and
● the effectiveness of sales and marketing efforts.
Even if a product displays a favorable efficacy and safety profile in preclinical and clinical studies and receives regulatory approval, market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical community and third-party payers on the benefits of our products may require significant resources and may never be successful. Our efforts to educate the marketplace may require more resources than are required by the methods marketed by our competitors. Any of these factors may cause any future products we may develop to be unsuccessful or less successful than anticipated.
Coverage and reimbursement decisions by third-party payers may have an adverse effect on pricing and market acceptance.
There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. To the extent that we retain commercial rights following clinical development, we may seek approval to market our product candidates in the United States, the European Union and other selected jurisdictions. Market acceptance and sales of our product candidates in both domestic and international markets, if approved, will depend significantly on the availability of adequate coverage and reimbursement from third-party payers for any of our product candidates and may be affected by existing and future healthcare reform measures. Third- party payers, such as government authorities, private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. For more information, see the section titled “Information on the Company – Pharmaceutical coverage, pricing and reimbursement.”
We cannot be certain that coverage and adequate reimbursement will be available for any of our products or product candidates, if approved. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, any of our product candidates, if approved. If reimbursement is not available or is available on a limited basis for any of our products or product candidates, if approved, we may not be able to commercialize successfully any such product candidates.
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Obtaining coverage and reimbursement approval for a product from a government or other third-party payer is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payer. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement or to have pricing set at a satisfactory level. If reimbursement of our future products, if any, is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, such that may result where alternative or generic treatments are available, we may be unable to achieve or sustain profitability.
In certain countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. To obtain reimbursement or pricing approval in some countries, we may be required to conduct additional clinical trials that compare the cost-effectiveness of our product candidates to other available therapies. In the United States, Medicare and Medicaid are significant third party payers. Medicare is administered by the Centers for Medicare & Medicaid Services (“CMS”), an agency within the U.S. Department of Health and Human Services and Medicaid is administered jointly by CMS and the individual states. Obtaining adequate coverage and reimbursement under Medicare and Medicaid is important for new drug products. Additionally, private payers may adopt coverage policies or reimbursement methodologies similar to Medicare. Reimbursement by a third-party payer may depend upon a number of factors, including the third-party payer’s determination that use of a product is: a covered benefit under its health plan; safe, effective and medically necessary; appropriate for the specific patient; cost-effective; and neither experimental nor investigational. Other third party payers may impose coverage criteria more extensive than compliance with FDA labeling. If reimbursement of any of our products or product candidates, if approved, is unavailable or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability of our products in such country.
The delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than European Union, law and policy. National governments and health service providers have different priorities and approaches to the delivery of healthcare and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most European Union member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing European Union and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize any products for which we have or will obtain marketing approval.
Legislative and regulatory activity may exert downward pressure on potential pricing and reimbursement for any of our product candidates, if approved, that could materially affect the opportunity to commercialize.
The United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell any of our products or product candidates profitably, if approved. Among policymakers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. For more information, see the section titled “ Information on the Company – Patient Protection and Affordable Care Act and healthcare reform.” We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:
● the demand for any of our product candidates, if approved;
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● the ability to set a price that we believe is fair for any of our product candidates, if approved;
● our ability to generate revenues and achieve or maintain profitability;
● the level of taxes that we are required to pay; and
● the availability of capital.
We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future in any jurisdiction, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or successfully commercialize our products or product candidates.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical and biologic products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations or regulations, guidance or interpretations of other regulatory authorities will be changed, or what the impact of such changes on the marketing approvals of our products or product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
Moreover, increasing efforts by governmental and third- party payers in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our products or product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent United States Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Recent CMS proposals, including the GLOBE, GUARD, and GENEROUS models which seek to introduce most-favored nation (MFN) pricing in Medicare and Medicaid, could materially impact our revenue.
We expect that the healthcare reform measures that have been adopted, and that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved products and could seriously harm our future revenues. Any reduction in reimbursement from Medicare or other government programs in the United States or in other jurisdictions may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or successfully commercialize our products.
Risks related to our reliance on third parties
We are heavily dependent upon our collaboration arrangements with Gilead and certain other third parties for the development and commercialization of our products and there can be no assurance that these arrangements will deliver the benefits we expect.
In July 2019, we entered into the OLCA, a ten-year global R&D collaboration with Gilead. In connection with our entry into the OLCA, we received an upfront payment of $3.95 billion and a $1.1 billion (€ 960 million) equity investment from Gilead. Under the OLCA, we fund and lead all discovery and development autonomously until the end of the relevant Phase 2 clinical study. After the completion of a qualifying Phase 2 clinical study (or in certain circumstances, the first Phase 3 clinical study), Gilead will have the option to acquire an exclusive commercial license to that program in all countries outside of Europe. If the option is exercised, we and Gilead will co-develop the compound and share costs equally. In addition, we are heavily dependent on Gilead for the commercialization of filgotinib.
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Gilead may not devote sufficient resources or give sufficient priority to the programs in respect of which it acquires a commercial license pursuant to the OLCA. Furthermore, Gilead may not be successful in the commercialization of filgotinib outside of Europe and further commercialization of filgotinib or other programs for which it acquires a commercial license, even when they do devote resources and prioritize their efforts for such programs.
In addition, the terms of the OLCA, as well as of any collaboration or other arrangement that we may establish may not ultimately prove to be favorable to us or may not be perceived as favorable, which may negatively impact the trading price of the ADSs or our ordinary shares. In addition, pursuant to the OLCA, we are entitled to certain option payments, tiered royalties and milestones on certain products. There can be no assurance that such payments will be sufficient to cover the costs of developing of the relevant product candidates.
We are subject to a number of additional risks associated with our dependence on our collaborations with third parties, the occurrence of which could cause our collaboration arrangements to fail. In particular, the collaboration we entered into in July 2019 is managed by a set of joint committees comprised of equal numbers of representatives from each of us and Gilead. Conflicts may arise between us and Gilead, such as conflicts concerning the interpretation of clinical data, the achievement of milestones and the interpretation of financial provisions or the ownership of intellectual property developed during the collaboration, and there can be no assurance that the joint committees will be able to resolve any such conflicts. If any such conflicts arise, Gilead could act in a manner adverse to our best interests. Any such disagreement could result in one or more of the following, each of which could delay or prevent the development or commercialization of product candidates subject to the collaboration arrangements and, in turn, prevent us from generating sufficient revenues to achieve or maintain profitability:
● reductions or delays in the payment of milestone payments, royalties or other payments we believe are due;
● actions taken by Gilead inside or outside our collaboration which could negatively impact our rights or benefits under our collaboration including termination of the collaboration for convenience; or
● unwillingness on the part of Gilead to keep us informed regarding the progress of its development and commercialization activities or regulatory approval or to permit public disclosure of the results of those activities.
In addition to the OLCA with Gilead, we may also enter into future collaborations that will give rise to similar risks, although our ability to enter into such collaborations may be limited given the scale of the OLCA.
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We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates, and our business could be substantially harmed.
We have relied upon and plan to continue to rely upon CROs to monitor and manage data for our preclinical and clinical programs. We rely on these parties for execution of our preclinical studies and clinical trials. We and our CROs also rely upon clinical sites and investigators for the performance of our clinical trials in accordance with the applicable protocols and applicable legal and regulatory requirements and IRB and scientific standards. Our CROs, as well as the clinical sites and investigators, may not perform our clinical trials in accordance with the applicable protocols and the applicable legal and regulatory requirements and scientific standards, or they may fail to report the results obtained in a timely and accurate manner. We need to have mechanisms in place to adequately manage, oversee and control our clinical trials, including selection of CROs, auditing activities, set-up (during which deliverables, timelines, roles and responsibilities are defined) and oversight during the conduct of such clinical trials. We, our CROs, the clinical sites and the investigators are required to comply with current GCPs and cGMPs, which are regulations and guidelines enforced by the FDA, the competent authorities of the member states of the European Economic Area (“EEA”) and comparable regulatory authorities for all of our products in clinical development. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, investigators and clinical sites. Upon inspection by a given regulatory authority, such regulatory authority may determine that any of our clinical trials or investigational products do not comply with GCP and GDP regulations. If we, any of our CROs or any of the clinical sites or investigators fail to comply with applicable GCPs, cGMPs or other applicable requirements, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA, EMA or comparable regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. Additionally, our clinical trial sites and investigators have in the past and may in the future engage in protocol deviations which could impact the overall interpretability of the outcomes of our clinical trials. We are also required to register certain clinical trials on government-operated databases and in the U.S. and the European Union to post the results of completed clinical trials on a government-sponsored database, such as ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
Many jurisdictions have mandatory clinical trial information obligations incumbent on sponsors. In the European Union, transparency requirements relating to clinical trial information are established in Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (the Clinical Trials Regulation (“CTR”)). The CTR establishes a general principle according to which information contained in Clinical Trials Information System (“CTIS”) shall be made publicly accessible unless confidentiality is justified on grounds of protecting personal data, or commercially confidential information, necessary to protect confidential communications between European Union Member States in relation to the preparation of an assessment report, or necessary to ensure effective supervision of the conduct of a clinical trial by European Union Member States. This confidentiality exception may be overruled if there is an overriding public interest in disclosure. The publication of data and documents in relation to the conduct of a clinical trial will take place in accordance with specific timelines. The timelines are established by the EMA and are determined based on the documents and the categorization of the clinical trial.
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Moreover, we may terminate clinical trials at any time for any reason, and any decision to do so will trigger clinical trial close-out obligations with clinical trial sites, investigators, CROs, and other vendors engaged in supporting the conduct of our clinical trials. We cannot control whether or not such parties may devote adequate resources or diligence to conducting and properly documenting these clinical trial close-out activities, which could impact the usability of any data we have obtained during the conduct of any such terminated clinical trials or other unforeseen harm to our reputation and future product development programs. Additionally, in the case of certain cell and gene therapy products, the FDA or foreign regulatory authorities may require ongoing safety follow-up post-trial closure for up to 15 years, including for terminated programs. We depend on clinical sites, investigators, and third parties for completing such follow-up and may be unable to ensure compliance with and completion of any required longer-term safety follow-up with prior clinical trial subjects, should such follow-up be required for any terminated or completed clinical trials.
In addition to GCPs, our clinical trials must be conducted with products produced under current cGMP regulations. Failure to comply with applicable protocols and regulations in the conduct of the clinical trials for our product candidates may require us to repeat clinical trials, which would delay the regulatory approval process.
Furthermore, the third parties conducting clinical trials on our behalf are not our employees, and except for remedies available to us under our agreements with such contractors, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development activities. These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to our clinical activities. If these third parties, including clinical investigators, do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, clinical data necessary for regulatory approvals for any current or future product candidates.
If any of our relationships with these CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on favorable or similar terms. In addition, switching or adding additional CROs involves additional cost and requires management time and focus. If CROs do not carry out their contractual duties or obligations successfully or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure (including by clinical sites or investigators) to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates and our costs could increase substantially.
If the third-party data and results we rely upon prove to be inaccurate, unreliable or not applicable to our product candidates, we could make inaccurate assumptions and conclusions about our product candidates, and our R&D efforts could be materially adversely affected.
We rely completely on third parties to manufacture our preclinical and clinical drug supplies and to produce commercial supplies of any approved product.
We do not currently have, nor do we plan to build, the infrastructure or capability internally to manufacture our drug supply for our approved products or preclinical and clinical drug supplies. We expect to continue to depend on contract manufacturers or other third-party manufacturers for the foreseeable future. This reliance on third parties may impact the availability of such drugs or drug candidates at an acceptable cost and/or quality. This could potentially delay, prevent or impair our development and commercialization efforts.
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If, for any reason, we were to experience an unexpected loss in the supply of any of our approved products, our product candidates, placebo or the comparator drugs used in certain of our clinical trials, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials or commercial distributions of our approved products.
The facilities used by our contract manufacturers and other third-party manufacturers, as applicable, to manufacture our approved products and our product candidates are subject to the pre-approval inspections of the FDA, EMA and other comparable regulatory authorities, which can be conducted after we submit the required approval applications to any relevant regulatory authorities, such as, for example, an NDA or BLA to the FDA. We monitor and are dependent on, but do not control, the implementation of the manufacturing process of our contract manufacturers and other third-party manufacturers, as applicable, for compliance with cGMP regulatory requirements for manufacture of any drug products. If our contract manufacturers or other third-party manufacturers, as applicable, do not successfully manufacture material that conforms to applicable specifications and the strict regulatory requirements of the FDA, EMA or other regulatory authorities, or if such authorities find deficiencies at the facility of contract manufacturers or third-party manufacturer, as applicable, or if such authorities are unable to conduct the inspections necessary to evaluate such facilities, we will likely not be able to secure and/or maintain regulatory approvals for our products manufactured at these facilities. This could significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
If we do not maintain our key manufacturing relationships, terminate any such relationships, or if any of our contract manufacturers fail to perform their obligations, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our products. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other foreign regulatory authorities.
Any change in manufacturer may also involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. In addition, we will need to verify that any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or another regulatory authority. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.
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In some cases, the technical skills required to manufacture our current or future products or product candidates may be unique or proprietary to the original contract manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. Furthermore, a contract manufacturer may possess or acquire technology related to the manufacture of our current or future product candidates that such contract manufacturer owns independently. This would increase our reliance on such contract manufacturer or require us to obtain a license from such contract manufacturer in order to have another contract manufacturer manufacture our current or future product candidates. We intend to utilize arrangements with third-party contract manufacturers for the commercial production of our current and future product candidates. This process is difficult and time consuming and we may face competition for access to manufacturing facilities as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing our current or future product candidates. Consequently, we may not be able to reach agreement with third-party manufacturers on satisfactory terms, which could delay our commercialization.
Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of our current or future product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our current or future product candidates. The facilities used by our contract manufacturers to manufacture our current or future product candidates must be evaluated by the FDA and certain other foreign regulatory authorities. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMPs. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we may not be able to secure and/or maintain regulatory approval for our product manufactured at these facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or other comparable foreign regulatory authority finds deficiencies or does not approve these facilities for the manufacture of our current or future product candidates, or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our current or future product candidates, if approved. Furthermore, if we are required to change contract manufacturers, we will be required to verify that the new contract manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations, which could result in further costs and delays. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our current or future product candidates and market our products, if approved.
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The FDA and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators also inspect these facilities to confirm compliance with cGMPs. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our current or any future product candidates and market our products following approval.
We and our manufacturers purchase the materials necessary to produce our product candidates for our clinical trials and our approved products from third-party suppliers. There are a limited number of suppliers for raw materials that we use to manufacture our drugs and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our product candidates for our clinical trials and our approved products. We do not control the process or timing of the acquisition of raw materials by our manufacturers, and delays may result for reasons beyond our control. If we or our manufacturers are unable to purchase these raw materials after regulatory approval has been obtained for our product candidates, the commercial launch of our products may be delayed or there may be a shortage in supply, which would impair our ability to generate revenues from the sale of our products. Additionally, if we receive regulatory approval for our product candidates, we may experience unforeseen difficulties or challenges in the manufacture of our products on a commercial scale compared to the manufacture for clinical purposes.
Risks related to our intellectual property
Our ability to compete may decline if we do not adequately protect our proprietary rights.
Future commercial success depends on obtaining, maintaining and successfully defending proprietary rights against third-party challenges for any future product and our current and any future product candidates. We will only be able to protect our product candidates and their uses from unauthorized use by third parties to the extent that valid and enforceable patents or effectively protected trade secrets cover them. Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including but not limited to:
● we may not have been the first to make the inventions covered by pending patent applications or issued patents;
● we may not have been the first to file patent applications for our product candidates or the compositions we developed or for their uses;
● others may independently develop identical, similar or alternative products or compositions and uses thereof;
● our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability;
● any or all of our pending patent applications may not result in issued patents;
● we may not seek or obtain patent protection in countries that may eventually provide us with significant business opportunities;
● any patents issued to us may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties;
● our compositions, methods and processes may not be patentable;
● others may design around our patent claims to produce competitive products which fall outside of the scope of our patents; or
● others may identify prior art or other bases which could invalidate our patents.
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Even if we have or obtain patents covering our product candidates or compositions, we may still be barred from making, using and selling our product candidates or technologies because of the patent rights of others. Others may have filed, and in the future may file, patent applications covering compositions or products that are similar or identical to ours. If a patent owned by a third party covers one of our product candidates or its uses, this could materially affect our ability to develop the product candidate or sell the resulting product if approved. Because patent applications are not published until 18 months from their priority date, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe. Additionally, because the scope of claims in pending patent applications can change, there may be pending applications for which claims do not currently cover any of our product candidates but may be altered such that one or more of our product candidates are covered when the resulting patents are issued. These patent applications may have priority over patent applications filed by us.
Moreover, even if we are able to obtain patent protection, such patent protection may be of insufficient scope to achieve our business objectives. For example (without any limitation), others may be able to develop a product that is similar to, or better than, ours in a way that is not covered by the claims of our patents.
Obtaining and maintaining a patent portfolio entails significant expenses and resources. Some of the expenses include filing fees, search and examination fees, grant fees, periodic maintenance fees, renewal fees, annuity fees, various other governmental fees on patents and/or fees associated with applications due in several stages over the lifetime of patents and/or applications, as well as the costs associated with complying with numerous procedural provisions during the patent application process. We may or may not choose to pursue or maintain protection for particular inventions. In addition, there are situations in which failure to make certain payments or noncompliance with certain requirements in the patent process can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If we choose to forgo patent protection or allow a patent application or a patent to lapse purposefully or inadvertently, our competitive position could suffer. Moreover, in some circumstances, we do not have the right to control the preparation, filing or prosecution of patent applications or to maintain certain patents covering technology subject to our collaboration or license agreements with third parties. For example, under the OLCA with Gilead, Gilead controls litigation for our patents covering filgotinib in jurisdictions outside the European region and for any optioned programs. Therefore, these patents and patent applications may not be prosecuted or enforced in a manner consistent with the best interests of our business.
Legal actions to enforce our patent rights can be expensive and may involve the diversion of significant management time. In addition, these legal actions could be unsuccessful and could also result in the invalidation of our patents or findings that they are unenforceable. We may or may not choose to pursue litigation or other actions against those that have infringed on our patents or used them without authorization, due to the associated expenses and time commitments of monitoring these activities. If we fail to protect or to enforce our intellectual property rights successfully, our competitive position could suffer, which could harm our results of operations.
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Pharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined to be adverse to us, could negatively impact our patent position.
The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. The interpretation and breadth of claims allowed in some patents covering pharmaceutical compositions may be uncertain and difficult to determine and are often affected materially by the facts and circumstances that pertain to the patented compositions and the related patent claims. The standards of the United States Patent and Trademark Office (“USPTO”), the European Patent Office and other foreign counterparts are sometimes uncertain and could change in the future. Consequently, the issuance and scope of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or circumvented. Certain U.S. patents and patent applications may also be subject to interference proceedings, and U.S. patents may be subject to reexamination proceedings, post-grant review and/or inter partes review in the USPTO. European patents and other foreign patents may also be subject to opposition or comparable proceedings in the corresponding foreign patent offices, which could result in either loss of the patents or denial of the patent applications or loss or reduction in the scopes of one or more of the claims of the patents or patent applications. In addition, such interference, reexamination, post-grant review, inter partes review and opposition proceedings may be costly. Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.
In addition, changes in or different interpretations of patent laws in the United States, European Union, and other jurisdictions may permit others to use our discoveries or to develop and commercialize our technology and products without providing any compensation to us, or may limit the number of patents or claims we can obtain. The laws of some countries do not protect intellectual property rights to the same extent as the laws of the U.S. and European Union and those countries may lack adequate rules and procedures for defending our intellectual property rights.
If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, we could lose our competitive advantages, and the competition we face would likely increase, likely reducing any potential revenues and adversely affecting our ability to attain or maintain profitability.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to patent protection, because we operate in the highly technical field of developing therapies, we rely in part on trade secret protection in order to protect our proprietary technology and processes. However, trade secrets are difficult to protect. It is our policy to enter into confidentiality and intellectual property assignment agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors. These agreements generally require that the other party keeps confidential and does not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. These agreements also generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Adequate remedies may not exist in the event of unauthorized use or disclosure of our confidential information. The disclosure of our trade secrets would impair our competitive position and may materially harm our business, financial condition and results of operations.
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In addition to contractual measures, we try to protect the confidential nature of our proprietary information using physical and technological security measures. Such measures may not, for example (without any limitation), in the case of misappropriation of a trade secret by an employee or a third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets, with protection varying across Europe and in other countries. Trade secrets may be independently developed by others in a manner that could prevent legal recourse by us. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
Filing, prosecuting and defending patents that cover our current and future product candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries could be less extensive than those in the United States and Europe, assuming that rights are obtained in the United States and Europe. Furthermore, even if patents are granted based on our European patent applications, we may not choose to perfect or maintain our rights in all available European countries. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as laws in the United States and Europe. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries, or from selling or importing products made using our inventions. The statutory deadlines for pursuing patent protection in individual foreign jurisdictions are based on the priority dates of each of our patent applications.
Competitors may use our technologies in jurisdictions where we do not pursue and obtain patent protection to develop their own products, and further, may export products to or otherwise infringe products in territories where we have patent protection, but enforcement is not as strong as it would be in the United States or Europe. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from so competing.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States and European Union. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protections, especially those relating to pharmaceuticals or biotechnologies. This could make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws, under which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors.
In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.
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Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. In addition, changes in the laws and legal decisions by courts in the United States, European Union and other jurisdictions may affect our ability to obtain adequate protection for our technology and the enforcement of intellectual property. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in intellectual property laws in the United States and around the world. From time to time, courts and other governmental authorities in the U.S., Europe, Japan and other jurisdictions may change the standards of patentability, and any such changes could have a negative impact on our business. For example, in Europe, a new unitary patent system took effect June 1, 2023, which significantly impacted European patents, including those granted before the introduction of such a system. Under the unitary patent system, European applications have the option, upon grant of patents, of becoming a Unitary Patents which will be subject to the jurisdiction of the Unitary Patent Court (the “UPC”). Given that the UPC is a new court system, it is evolving and there is limited jurisprudence, thus increasing the uncertainty surrounding the outcomes of any litigation. Patents granted before the implementation of the UPC have the option of opting out of the jurisdiction of the UPC and remaining national patents in the UPC countries. Patents that are under the jurisdiction of the UPC could potentially be vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries that are signatories to the UPC. We cannot predict with certainty the long-term effects of any potential changes. Certain jurisdictions, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties under certain circumstances. In those jurisdictions, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents. In addition, many jurisdictions limit the enforceability of patents against government agencies or government contractors. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected.
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Our inability to protect our intellectual property or failure to maintain the confidentiality and integrity of data or other sensitive Company information, due to cyber-attack or other events, could have a material adverse effect on our business.
Our success and competitive position are dependent in part upon our proprietary intellectual property. We rely on a combination of patents and trade secrets to protect our proprietary intellectual property, and we expect to continue to do so. Although we seek to protect our proprietary rights through a variety of means, we cannot guarantee that the protective steps we have taken are adequate to protect these rights. Patents issued to or licensed by us in the past or in the future may be challenged and held invalid. In addition, as our patents expire, we may be unsuccessful in extending their protection through patent term extensions or supplementary protection certificates. The expiration of, or the failure to maintain or extend our patents, could have a material adverse effect on us.
We also rely on confidentiality agreements with certain employees, consultants, and other third parties to protect, in part, trade secrets and other proprietary information. These agreements could be breached, and we may not have adequate remedies for such breaches. In addition, others could independently develop substantially equivalent proprietary information or gain access to our trade secrets or proprietary information.
Our intellectual property, other proprietary technology and other sensitive Company information are dependent on sophisticated information technology systems and are potentially vulnerable to cyber -attacks, losses, damages, destruction from system malfunctions, computer viruses, loss of data privacy or misappropriations or misuses of such intellectual property, proprietary technology, and sensitive Company information by those with permitted access and other events. While we have invested to protect our intellectual property and other information, and continue to upgrade and enhance our systems to keep pace with continuing changes in information processing technology, there can be no assurance that our precautionary measures will prevent breakdowns, breaches, cyber-attacks or other events. Such events could have a material adverse effect on our reputation, financial condition, or results of operations.
Risks related to intellectual property litigation
We may be subject to claims by third parties asserting ownership or commercial rights to inventions we develop or obligations to make compensatory payments to employees.
Third parties may in the future make claims challenging the inventorship or ownership of our intellectual property. We have written agreements with collaboration partners that provide for the ownership of intellectual property arising from our collaborations. Some of these agreements provide that we must negotiate certain commercial rights with collaboration partners with respect to joint inventions or inventions made by our collaboration partners that arise from the results of the collaborations. In some instances, there may not be adequate written provisions to clearly address the resolution of intellectual property rights that may arise from a collaboration. If we cannot successfully negotiate sufficient ownership and commercial rights to the inventions that result from the collaboration with a third-party collaboration partner or if disputes otherwise arise with respect to the intellectual property developed in the framework of the collaboration, we may be limited in our ability to capitalize on the market potential of these inventions. In addition, we may face claims by third parties that our agreements with employees, contractors or consultants obligating them to assign intellectual property to us are ineffective or in conflict with prior or competing contractual obligations of assignment, which could result in ownership disputes regarding intellectual property that we have developed or will develop and may, as a result, interfere with our ability to capture the commercial value of such inventions. Litigation may be necessary to resolve an ownership dispute, and if we are not successful, we may be precluded from using certain intellectual property or may lose our exclusive rights to that intellectual property. Either outcome could have an adverse impact on our business.
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While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing or obtaining such an agreement with each party who, in fact, develops intellectual property that we regard as our own. In addition, such agreements may be breached or may not be self-executing, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of the property that we consider to be our intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
We employ individuals who were previously employed at universities, pharmaceutical companies or biopharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently, or otherwise, used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. We cannot make assurances that our business, products, commercialization activities, and methods do not or will not infringe the patents, trademarks or other intellectual property rights of third parties.
There is significant litigation in the pharmaceutical industry regarding patent and other intellectual property rights. While we are not currently subject to any pending intellectual property litigation, and are not aware of any such threatened litigation, we may be exposed to future litigation by third parties based on claims that our products or our product candidates, technologies or activities infringe the intellectual property rights of others. If our development activities are found to infringe any such patents, we may have to pay significant damages or seek licenses to such patents. A patentee could prevent us from using the patented drugs or compositions. We may need to resort to litigation to enforce a patent issued to us, to protect our trade secrets or to determine the scope and validity of third-party proprietary rights. From time to time, we may hire scientific personnel or consultants formerly employed by other companies involved in one or more areas similar to the activities conducted by us. Either we or these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of prior affiliations. Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court or redesign our products. Patent litigation is costly and time-consuming. We may not have sufficient resources to bring these actions to a successful conclusion. Any adverse ruling or perception of an adverse ruling in defending ourselves against these claims could have a material adverse impact on our cash position and the price of the ADSs or our ordinary shares. Any legal action against us or our collaboration partners could lead to:
● payment of substantial damages for past use of the asserted intellectual property and potentially treble damages, if we are found to have willfully infringed a party’s patent rights;
● injunctive or other equitable relief that may effectively block our ability to further develop, commercialize and sell our product candidates; or
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● us, or our collaboration partners, having to enter into license arrangements that may not be available on commercially acceptable terms, if at all, all of which could have a material adverse impact on our cash position and business and financial condition. As a result, we could be prevented from commercializing current or future product candidates.
Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.
Issued patents covering our approved products and product candidates could be found to be invalid or unenforceable if challenged in court
If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering our approved product or one of our product candidates, the defendant could counterclaim that the patent covering our approved product or one of our product candidates is invalid and/or unenforceable. In patent litigation, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.
Grounds for a validity challenge include alleged failures to meet any of several statutory requirements in most jurisdictions, including lack of novelty, obviousness or non-enablement. In the United States, grounds for unenforceability assertions include allegations that someone connected with the prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings. Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our approved products, product candidates or competitive products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to validity, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our approved products and/or our product candidates. Such a loss of patent protection would have a material adverse impact on our business.
Risks related to our employee matters
Our future success depends on our ability to retain the members of our Executive Committee and to attract, retain and motivate qualified personnel, consultants and advisors. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our industry has experienced a high rate of turnover in management and other personnel over recent years, and we have effected significant changes in our Executive Committee and Board of Directors during financial year 2025 as a result of our change in business strategy, to ensure that our management and Directors have the requisite experience and capabilities, including corporate, business development and strategic assessment capabilities, to implement our revised business strategy. Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel, many of whom are instrumental for us and have substantial experience with our therapies and related technologies. We are highly dependent on our management, scientific and medical personnel, especially our Executive Committee, which at the date of this annual report is comprised of: (i) Henry Gosebruch, our Chief Executive Officer (the “CEO”); (ii) Aaron Cox, our Chief Financial Officer; and (iii) Fred Blakeslee, our General Counsel, each of whose services are critical to the successful implementation of our product candidates’ acquisition, development and regulatory strategies. To our best knowledge, we are not aware of any present intention of any of these individuals to leave our Company. In order to induce valuable employees to continue their employment with us, we have granted subscription rights and restricted stock units (“RSUs”) that vest over time. The value to employees of subscription rights that vest over time is significantly affected by movements in our share price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies.
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Despite our efforts to retain valuable employees, members of our management, scientific, development, and medical teams may terminate their employment with us at any time, with or without notice, particularly in light of the wind-down of our cell therapy activities. The loss of the services of any of the members of our Executive Committee or other key employees could delay our business development, research, development and other activities, and our inability to find suitable replacements could harm our business, financial condition, strategic reorientation and prospects. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers, as well as junior, mid-level and senior personnel.
We may not be able to attract or retain qualified management and personnel in the future due to the intense competition for a limited number of qualified personnel among biopharmaceutical, biotechnology, pharmaceutical and other businesses. Many of the other pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. Therefore, we might not be able to attract or retain these key personnel on conditions that are economically acceptable. If we are unable to continue to attract and retain-high quality personnel, the rate and success at which we can develop and commercialize products or product candidates could be adversely affected.
Additionally, the wind-down of our cell therapy activities and related workforce reduction could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, attrition beyond our reduction in workforce and reduced employee morale, which may cause remaining employees to seek alternative employment. Our ability to successfully complete one or more strategic transactions depends in part on our ability to retain certain of our remaining personnel, including members of our senior management. If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of strategic transactions as well as our ongoing business operations and overall business strategy.
Furthermore, we will need to recruit new managers and qualified scientific, regulatory and financial personnel to develop our business as we expand into the fields that will require additional skills and expertise. Our inability to attract and retain these key personnel could prevent us from achieving our objectives and implementing our business strategy, which could have a material adverse effect on our business and prospects.
Risks posed by the improper conduct of employees, agents, contractors, CROs, consultants, vendors or collaboration partners could adversely affect our reputation and our business, prospects, operating results and financial condition.
We cannot ensure that our compliance controls, policies and procedures will in every instance protect us from acts committed by our employees, agents, contractors, CROs, consultants, vendors or collaboration partners that would violate the laws or regulations of the jurisdictions in which we operate, including, without limitation, healthcare, employment, securities, manufacturing standards, data manipulation, scientific fraud, foreign corrupt practices, environmental, competition and patient privacy and other privacy and data protection laws and regulations. Such improper actions could subject us to civil or criminal investigations and monetary and injunctive penalties and could adversely impact our ability to conduct business and obtain and maintain favorable operating results and reputation.
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In particular, our business activities may be subject to the Foreign Corrupt Practices Act (“FCPA”), and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the UK Bribery Act of 2010. The FCPA generally prohibits offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non- U.S. governments. Additionally, in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their governments, and the purchasers of pharmaceuticals are governmental entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA. Recently the SEC and U.S. Department of Justice have increased their FCPA enforcement activities with respect to pharmaceutical companies. There is no certainty that all of our employees, agents, contractors, CROs, consultants, vendors or collaboration partners, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws and regulations. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person could allege such misconduct, even if none occurred. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results and financial condition.
We could be subject to liabilities under human rights, corruption, environmental, sustainability, health and safety laws or regulations or fines, penalties or other sanctions, if we fail to comply with such laws or regulations or otherwise incur costs that could have a material adverse effect on the success of our business.
We are subject to numerous human rights, corruption, environmental, sustainability, health and safety laws, regulations, and permitting requirements, including those governing laboratory procedures, decontamination activities and the handling, transportation, use, remediation, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous materials, including chemicals, radioactive isotopes and biological materials and produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risks of contamination, injury or illness from these materials or wastes either at our sites or at third-party disposal sites. In the event of such contamination, injury or illness, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs and reputational loss associated with civil or criminal fines and penalties. Although we maintain workers’ compensation insurance to cover costs and expenses we may incur due to illness or injuries to our employees resulting from the use of hazardous materials or other work-related illnesses or injuries, this insurance may not provide adequate coverage against potential liabilities.
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In addition, we may incur substantial costs in order to comply with current or future environmental, sustainability, health, and safety laws, regulations or permitting requirements, in which case our research, development or other efforts may be interrupted or delayed, and our financial condition and results of operation may be materially adversely affected. As of the date of this annual report, we are subject to the EU’s Corporate Sustainability Reporting Directive (“CSRD”) and are therefore required to report in our annual report on a broad range of sustainability-related impacts, risks, and opportunities on the basis of the European Sustainability Reporting Standards, which require, in particular, disclosures on environmental protection, social responsibility, and treatment of employees, respect for human rights, anti-corruption, bribery, and diversity. In connection with these reporting obligations, we are required to formulate long-term Environmental Social and Governance targets, policy, and strategic plans and to conduct due diligence for our own operations and supply chain. Because the CSRD requires reporting based on a double materiality assessment, we need to be in a position to make both (i) an inside-out assessment of impact materiality (meaning a consideration of the impact of our corporate activity on sustainability matters from the perspective of citizens, consumers, employees, etc.) and (ii) an outside-in assessment of financial materiality (meaning a consideration of sustainability matters which, from the investor perspective, are material to our development, performance and financial position). These current or future laws, regulations, and permitting requirements may impair our research, development, or production efforts. Failure to comply with these laws, regulations, and permitting requirements also may result in substantial fines, penalties, or other sanctions. As an example, climate change and, more specifically, the related current and future regulatory requirements, as well as the accelerated transition to a low carbon economy globally, might adversely impact our compliance status and value chain, if not addressed adequately.
Environmental regulations are also the subject of evolving legislative change. On December 9, 2025, the European Parliament and Council reached provisional agreement on an Omnibus Package substantively amending the CSRD and significantly reducing the number of entities falling in scope of the CSRD. The provisional agreement was then approved on December 16, 2025, by the European Parliament, with the final text requiring the final approval of the Council. After publication of the implementing directive and its entry into force, each member state will need to transpose all provisions of the directive within 12 months. Separately, the application of the CSRD to companies who are currently in scope but who have not yet started reporting has also been postponed by two years by Directive (EU) 2025/794 (known as the “Stop-the-Clock” directive). Expected and future legislative changes may therefore result in us no longer being in scope of the CSRD in the future, which would affect our compliance status and the reporting requirements we are subject to.
Risks related to our business operations and growth
Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions that the operation of our business may rely upon, which could negatively impact our business.
The ability of the FDA and other comparable regulatory agencies to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s or other comparable regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees and other events that may otherwise affect the FDA’s or other comparable regulatory authorities’ ability to perform routine functions. Average review times at the FDA and other comparable regulatory authorities have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund R&D activities, is subject to the political process, which is inherently fluid and unpredictable.
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Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. presidential administration has issued certain policies and executive orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.
If a prolonged government shutdown occurs, or if renewed global health concerns, funding shortages or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
If we fail to manage our growth effectively, our ability to develop and commercialize products could suffer.
We expect that as we execute on our business strategy and, our clinical product candidates continue to progress in development, and we continue to build our development, and medical organizations, we will require significant additional investment in personnel, management and resources. Our ability to achieve our R&D objectives depends on our ability to respond effectively to these demands to expand our internal organization, systems, controls and facilities to accommodate additional anticipated growth and upon our management developing and implementing strategies for us to realize these objectives. If we are unable to manage our growth effectively, our business could be harmed and our ability to execute our business strategy could suffer.
In particular, following the wind-down of our cell therapy activities and the related reduction in workforce, we expect our headcount to be reduced by approximately 365 employees. Because we intend to expand our pipeline and organization through strategic acquisitions, our organization may grow rapidly as a result of such acquisitions, and we may have additional difficulties in managing the rapid contraction and expansion of our operations, including difficulty in identifying, recruiting, maintaining and integrating personnel, operations and financial and other controls and systems relevant to any acquired product candidates. Both the reduction in force and any subsequent expansion of our Company may result in the loss of additional employees and reduced productivity among remaining employees. See “—Risks related to our business strategy—Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction and further develop and, if approved, commercialize any product candidate acquired in such transaction” for more information.
As a result of our limited financial, manufacturing and management resources, we may forgo or delay pursuit of opportunities with potential product candidates that later prove to have greater market potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
We must maintain effective internal control over financial reporting, and if we are unable to do so, the accuracy and timeliness of our financial reporting may be adversely affected, which could have a material adverse effect on our business, investor confidence and market price.
We must maintain effective internal control over financial reporting in order to accurately and timely report our results of operations and financial condition. We often use estimates and assumptions concerning the future. For more information, please see the section entitled “Critical accounting judgments and key sources of estimation uncertainty”. In addition, because we are a United States public company, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), requires, among other things, that we assess the effectiveness of our disclosure controls and procedures annually, and the effectiveness of our internal control over financial reporting at the end of each fiscal year.
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Section 404 of the Sarbanes-Oxley Act (“Section 404”), requires us to perform system and process evaluations and to test of our internal control over financial reporting to allow management to report on, and our independent registered public accounting firm to attest to, the effectiveness of our internal control over financial reporting. In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses, or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. The rules governing the standards that must be met for our management to assess our internal control over financial reporting pursuant to Section 404 are complex and require significant documentation, testing and possible remediation. These stringent standards require that our Audit Committee be advised and regularly updated on management’s review of internal control over financial reporting. Our compliance with applicable provisions of Section 404 will require that we incur substantial accounting expenses and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. Moreover, if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of the ADSs or our ordinary shares could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources. Furthermore, investor perceptions of our Company may suffer if deficiencies are found, and this could cause a decline in the market price of the ADSs or our ordinary shares. Irrespective of compliance with Section 404, any failure of our internal control over financial reporting could have a material adverse effect on our stated operating results and harm our reputation. If we are unable to implement these requirements effectively or efficiently, it could harm our operations, financial reporting or financial results, and could result in an adverse opinion on our internal control over financial reporting from our independent registered public accounting firm.
Our information technology system and networks and those of our third party partners or vendors could face serious disruptions or suffer security breaches, incidents, or compromises that could adversely affect our business.
To meet business objectives, we rely on both internal information technology (“IT”) systems and networks, as well as those of third parties and their vendors, to process and store confidential and sensitive data, including confidential research, business plans, financial information, intellectual property, patient data, customer data and personal data that may be subject to legal protection. The extensive information security and cybersecurity threats, which affect companies globally, pose a risk to the security and availability of these IT systems and networks, as well as to the confidentiality, integrity and availability of confidential and sensitive data.
These threats may include, but are not limited to, social-engineering attacks (including through phishing attacks), business email compromises, online and offline fraud, malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, access attacks (such as credential stuffing), ransomware attacks and supply-chain attacks. These types of incidents continue to be prevalent and pervasive across industries, including in our industry, and such attacks on our systems have occurred in the past and are expected to occur in the future. In addition, we expect the amount and sophistication of the perpetrators of these attacks to continue to expand. Our systems and networks, and those of our third parties and vendors, may also be subject to software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware or telecommunications failures, earthquakes, fires, floods and other similar threats.
We continuously assess these threats and make investments to enhance internal protection, detection, and response capabilities, as well as to enhance our third-party providers’ capabilities and controls to address this risk.
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However, because of the frequently changing attack techniques, along with the increased volume and sophistication of the attacks, there is the potential risk for us to be adversely impacted. Although we have invested time and resources into the protection of our information technology and other internal infrastructure systems, we and our vendors, like other companies in the industry, have experienced non-material attacks from time to time, and we and our vendors may experience other such attacks in the future.
The impact of security breaches and significant disruption in the availability of our information technology and networks could result in reputational, competitive, operational or other business harm, financial costs, litigation (including class action claims), regulatory action (for example, investigations, fines, penalties, audits and inspections), as well as interruptions to our collaborations with our partners, and delays in our research, development work, regulatory approval efforts and other work.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our approved product and any future approved products.
We face an inherent risk of product liability as a result of the clinical testing of our product candidates and an even greater risk in connection with the commercialization of our drugs (if approved). For example (without any limitation), we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing, commercialization, use or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Physicians and patients may not comply with any warnings that identify known potential adverse effects and patients who should not use our products. Any claims against us, regardless of their merit, could be difficult and costly to defend, and could materially adversely affect the market for our products and product candidates or any prospects for commercialization or our products and product candidates. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to stop development or, if approved, limit commercialization of our products and product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcomes, liability claims may result in:
● delay or termination of clinical trials;
● injury to our reputation;
● withdrawal of clinical trial participants or difficulties in recruiting new trial participants;
● initiation of investigations by regulators;
● costs to defend or settle the related litigation;
● a diversion of management’s time and our resources;
● substantial monetary awards to trial participants or patients;
● decreased demand for our approved product, any future products or our product candidates;
● product recalls, withdrawals or labeling, marketing or promotional restrictions;
● loss of revenues from product sales; and
● the inability to commercialize our approved product or any of our product candidates, if approved.
Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the development or commercialization of our products and product candidates. We currently carry clinical trial liability insurance and product liability insurance at levels that we believe are appropriate for our clinical trials and our commercialization activities.
Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital or other assets to pay such amounts. As a result, our business operations could be impaired. We may not be able to maintain insurance coverage at a reasonable cost or to obtain insurance coverage that will be adequate to satisfy any liability that may arise.
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Our relationships with customers and third-party payers may be subject, directly or indirectly, to applicable anti-kickback laws, fraud and abuse laws, false claims laws, health information privacy and security laws and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
We are subject to additional healthcare statutory and regulatory requirements and enforcement by the federal government, the states and foreign governments in which we conduct our business. Healthcare providers, physicians and third-party payers play primary roles in the recommendations and prescriptions of any of our approved products and product candidates for which we obtain marketing approval. Our current and future arrangements with third -party payers and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships with third parties through which we market, sell and distribute any products for which we obtain marketing approval. In addition, we may be subject to the privacy, data protection and security regulations of the European Union, the United States and other jurisdictions in which we conduct our business. For more information, see section titled “Information on the Company – Other healthcare laws and compliance requirements.”
The scope and enforcement of each of these laws are uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedents and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages (including, but not limited to, reputational harm), fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, defending against any such actions can be costly and time-consuming, and may require significant financial and personnel resources. Therefore, even if we are successful in defending ourselves against any such actions that may be brought against us, our business may be impaired. If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment. If any legislative and/or regulatory initiatives and changes would lead to increased restrictions on the marketing of our approved products and product candidates or to limitations of the funds available for healthcare in any relevant jurisdictions, reimbursement levels could be reduced, the prices we may set would likely be affected and we would likely be negatively impacted in our ability to successfully and profitably market our approved products and product candidates. If any of the above occur, our ability to operate our business and our results of operations could be adversely affected.
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We may fail to comply with evolving privacy and data protection laws and requirements in effect in the European Union, United Kingdom, and other jurisdictions.
In the European Union, the EEA and the United Kingdom, we may face particular privacy, data security, privacy and data protection risks in connection with requirements of the Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons, with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (the “EU GDPR”), the EU GDPR in such form as incorporated into the laws of the UK (the “UK GDPR”), and other applicable implementing or supplemental data protection laws and regulations in effect in the EEA and UK. The UK’s data protection regime is independent from, but aligned to, the EU’s data protection regime. Unless stated otherwise in this annual report, the “GDPR” refers to both the EU GDPR and UK GDPR, and applies inter alia to the processing of personal data in connection with (a) the offering of goods or services to/the monitoring of the behavior of individuals in the EEA/UK; or (b) the activities of our establishments in the EEA/UK. The GDPR impose strict data protection obligations for controllers and processors of personal data, including, for example, expanded disclosures about how personal data is to be used, limitations on retention of data, enhanced requirements for securing personal data, mandatory data breach notification requirements, appointing data protection officers, conducting data protection impact assessments and the creation of onerous liabilities on controllers and processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside of the UK and EEA that do not ensure an adequate level of protection, including the United States in certain circumstances, unless derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses (“SCCs”), and the UK International Data Transfer Agreement or Addendum (the “UK IDTA”)), have been put in place, and transfer impact assessments increase substantially the penalties to which we could be subject if carried out. Any inability to transfer personal data from the UK or EEA to the United States in compliance with data protection laws may impede our operations and may adversely affect our business and financial position. Following the UK’s exit from the EU (“Brexit”), there will be increasing scope for divergence in application, interpretation and enforcement of the data protection laws between these territories. For example, the UK has introduced the Data Reform Bill into the UK legislative process with the intention for this bill to reform the UK’s data protection regime following Brexit. If passed, the final version of the Data Reform Bill may have the effect of further altering the similarities between the UK and EEA data protection regimes and threaten the UK adequacy decision from the EU Commission allowing the free flow of personal data from the UK to the EEA, which may lead to additional compliance costs and could increase our overall risk. This lack of clarity on future UK laws and regulations and their interaction with those of the EEA could add legal risks, uncertainty, complexity and costs to our handling of EEA and UK personal data and our privacy and security compliance programs. This lack of clarity could also require us to implement different compliance measures for the UK and EEA.
Failure to comply with the requirements of the GDPR and the related national data protection laws of the EEA member states and the UK, which may deviate slightly from the GDPR, may result in warning letters, mandatory audits, suspension of processing and substantial financial penalties, including possible fines of up to € 20,000,000 (€17.5 million for the UK GDPR) or up to 4% of our total worldwide annual turnover of the preceding year for the most serious infringements. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. The GDPR increases our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place and maintain additional mechanisms to ensure compliance with the GDPR. Compliance with the GDPR is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and, despite those efforts, there is still a risk that we may be subject to fines and penalties, litigation and reputational harm in connection with our personal data-processing activities. A similar legislative framework, including similar obligations and penalties, applies in Switzerland, where similar efforts are needed.
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If we are investigated by a data protection authority, we may face fines and other penalties. Any such investigation or charges by data protection authorities could have a negative effect on our existing business and our ability to attract and retain new clients or pharmaceutical partners. We may also experience hesitancy, reluctance or refusal by European or multi-national clients or pharmaceutical partners to continue to use our products due to the potential risk exposure resulting from the current (and, in particular, future) data protection obligations imposed on them by certain data protection authorities in interpretation of current laws, including the GDPR. Such clients or pharmaceutical partners may also view any alternative approaches to compliance as being too costly, too burdensome, too legally uncertain or otherwise objectionable, and therefore, they may decide not to do business with us. Any of the foregoing could materially harm our business, prospects, financial condition and results of operations.
Despite our efforts to ensure compliance with the GDPR, we may not be successful, either due to internal or external factors, such as resource allocation limitations. Non-compliance could result in proceedings against us by governmental entities, customers, data subjects, consumer associations or others, as well as in penalties issued by data protection authorities, as is also stated above.
We may also fail to comply with other privacy and data protection laws and regulations in other jurisdictions where we are active and/ or operating, including but not limited to the United States.
Although we have invested time and resources in the protection of our personal data and information technology and monitors our systems on an ongoing basis, some immaterial incidents have occurred, and, in respect of which, we have taken appropriate measures. To date, no material risk has been identified, and our business and operations have not been materially impacted by such incidents.
Business interruptions could delay us in the process of developing our product candidates.
Loss of our laboratory, warehouse or other real estate facilities through fire or other causes could have an adverse effect on our ability to continue to conduct our business. We currently have insurance coverage to compensate us for such business interruptions; however, such coverage may prove insufficient to compensate us fully for any potential damages to our business resulting from any significant property or casualty losses to our facilities.
We may undertake strategic acquisitions in the future, and any difficulties posed by integrating such acquisitions could adversely affect our share price and results of operations.
We may acquire companies, businesses and products that complement or augment our existing business. Because our programs may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license or use these proprietary rights. We may be unable to acquire or in-license any compositions, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. The acquisition and licensing of third-party intellectual property rights is a competitive area, and other companies that have a competitive advantage over us due to their size, cash resources or other factors may pursue strategies to in-license or acquire third-party intellectual property rights that we may consider attractive. We may not be able to integrate any acquired companies, businesses or products successfully or operate any acquired companies, businesses or products profitably. Integrating any newly acquired companies, businesses or products could be expensive and time-consuming. Integration efforts often take a significant amount of time, place a significant strain on managerial, operational and financial resources, can result in losses of key personnel and can prove to be more difficult or expensive than we predict. The diversion of our management’s attention and any delay or difficulties encountered in connection with any future acquisitions or in-licensing that we may consummate could result in the disruption of our ongoing business or inconsistencies in standards and controls that could negatively affect our ability to maintain third-party relationships. Moreover, we may need to raise additional funds through public or private debt or equity financing or issue additional shares to acquire any businesses or products, which may result in dilution for shareholders or the incurrence of indebtedness.
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As part of our efforts to acquire companies, businesses or product candidates, or to enter into other significant transactions, we conduct business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in the transactions. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, might not realize the intended advantages of the transactions. If we fail to realize the expected benefits from the acquisitions we may consummate in the future, or that we have consummated in the past, whether as a result of unidentified risks or liabilities, integration difficulties, regulatory setbacks, litigation with current or former employees or other events, our business, results of operations and financial condition could be adversely affected. If we acquire product candidates, we will also need to make certain assumptions about, among other things, development costs, the likelihood of receiving regulatory approval and the market for such product candidates. Our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of these transactions.
In addition, we will likely experience significant charges to earnings in connection with our efforts, if any, to consummate acquisitions. For transactions that are ultimately not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants and other advisors in connection with our efforts. Even if our efforts are successful, we may incur, as part of a transaction, substantial charges for closure costs associated with the elimination of duplicate operations and facilities and acquired in-process R&D charges. In either case, the incurrence of these charges could adversely affect our results of operations for particular periods.
Actions of activist shareholders could cause us to incur substantial costs, divert the attention and resources of our management and our Directors and have an adverse effect on our business and trading price.
From time to time, we may be subject to proposals by shareholders urging us to take certain corporate actions or to nominate certain individuals to our Board of Directors. If activist shareholder activities by shareholders ensue, our business could be adversely affected, as responding to actions by activist shareholders can be costly and time-consuming, disrupt our operations and divert the attention of management and Directors. For example (without any limitation), we may be required to retain the services of various professionals to advise us on activist shareholders’ matters, including legal, financial and communications advisors, the costs of which may negatively impact our future financial results. In addition, perceived uncertainties as to our future direction, strategy or leadership created as a consequence of activist shareholders’ initiatives may result in the loss of potential business opportunities, harm our ability to attract new investors, customers and employees, and cause the price of our ADSs or ordinary shares to experience periods of volatility or stagnation.
Our international operations subject us to various risks, and our failure to manage these risks could adversely affect our results of operations.
We could face significant operational risks as a result of doing business internationally, which could have a material adverse effect on our business, financial condition and results of operations, such as (without any limitation):
● fluctuations in foreign currency exchange rates;
● potentially adverse and/or unexpected tax consequences, including penalties due to the failure of tax planning or challenges by tax authorities on the basis of transfer pricing and liabilities imposed from inconsistent enforcement;
● potential changes to the accounting standards, which may influence our financial situation and results;
● becoming subject to the different, complex and changing laws, regulations and court systems of multiple jurisdictions and thus needing to comply with a wide variety of foreign laws, treaties and regulations;
● reduced protection of, or significant difficulties in enforcing, intellectual property rights in certain countries;
● difficulties in attracting and retaining qualified personnel;
● restrictions imposed by local labor practices and laws on our business and operations, including unilateral cancellation or modification of contracts;
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● rapid changes in global government, economic and political policies and conditions, political or civil unrest or instability, terrorism or epidemics and other similar outbreaks or events and potential failure in maintaining the confidence of our suppliers or customers due to such changes or events; and
● tariffs (including tariffs that have been or may in the future be imposed by the United States or other countries), trade protection measures, import or export licensing requirements, trade embargoes, economic sanctions, other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade) and protectionist or retaliatory measures taken by the United States or other countries.
Unforeseen or catastrophic events, including extreme weather events and other natural disasters, man-made disasters or the emergence of epidemics, global conflicts or geopolitical issues, could cause a disruption in our operations or other consequences that could have a material adverse effect on our financial condition and results of operations.
The occurrence of unforeseen or catastrophic events, including extreme weather events and other acts of god or natural disasters, man-made disasters, electricity or telecommunication interruptions, geopolitical and other economic or political conditions or events (such as the armed conflict between Russia and Ukraine, the conflict in Israel and Gaza, or the conflict between U.S. and Iran) or the emergence of epidemics or diseases, depending on their scale, may cause different degrees of damage to national and local economies and could cause a disruption in our operations and have a material adverse effect on our financial condition and results of operations. Such events may also cause the market price and demand for our ADSs or ordinary shares to fluctuate substantially. Man- made disasters, epidemics or disease and other events connected with the regions in which we operate could have similar effects. If a natural or man-made disaster, electricity or telecommunication interruption or other event were to occur that prevents us from using all or a significant portion of our facilities, that damages critical infrastructure, such as clinical trial sites or the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupts operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could have a material adverse effect on our business.
Current geopolitical tensions with China may also have an effect on our business. Our use of foreign CROs and CDMOs in some jurisdictions may be or may become subject to U.S. legislation, sanctions, tariffs, trade restrictions and/or other regulatory requirements, which may increase the cost of and cause delays in the procurement or supply of materials for, or manufacture of, our product candidates or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies.
For example, the U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern,” or entering into, extending, or renewing any contracts with entities that use such biotechnology equipment or services from “biotechnology companies of concern.” Congress has interpreted a “biotechnology company of concern” as an entity that is under the control of a foreign adversary and that poses a risk to national security based on its research or multiomic data collection. While the U.S. BIOSECURE Act has a grandfathering period of five years for existing contracts, and has carveouts for manufacture of drugs for supply under Medicaid and Medicare Part B, subject to the Secretary of Veteran Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. This and similar laws could have the potential to restrict the ability of companies to work with certain Chinese biotechnology companies of concern without losing the ability to contract with, or otherwise receive funding from, the U.S. government.
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The increasing use of social media platforms presents risks and challenges.
We and our employees are increasingly utilizing social media tools as a means of communication both internally and externally. Despite our efforts to monitor evolving social media communication guidelines and comply with applicable rules, there is risk that the use of social media by us or our employees to communicate about our products and product candidates, operations or business may result in us being found in violation of applicable legal or contractual requirements. In addition, our employees may knowingly or inadvertently make use of social media in ways that may not comply with our social media policy or other legal or contractual requirements, which may give rise to liability, lead to the loss of trade secrets or other intellectual property or result in the public exposure of personal information of our employees, clinical trial patients, collaboration partners and others and which could have an adverse effect on our business, financial conditions and results of operations. Furthermore, negative posts or comments about us or our products on social media could seriously damage our reputation, brand image and goodwill.
In addition, it is possible for individuals or groups to target companies with disruptive social media campaigns related to requests for access to unapproved drugs for patients with significant unmet medical needs. If we experience such a social media campaign regarding any of our current or future decisions to provide or not provide access to our product candidates under an expanded access policy, our reputation may be negatively affected and our business may be harmed.
Risks related to tax and other financial matters
If we are unable to use tax loss carryforwards to reduce future taxable income or benefit from favorable tax legislation, our business, results of operations and financial condition may be adversely affected.
As of December 31, 2025, we had cumulative carryforward tax losses of €823.1 million related to entities in Belgium, and €20.0 million related to the other entities of our Galapagos Group, as defined below. These are available to carry forward and offset against possible future taxable income for an indefinite period in Belgium, but €9.1 million of these tax loss carryforwards in the United States will expire in the future. If we are unable to use tax loss carryforwards to reduce possible future taxable income or in case of changes in tax regulations affecting the use of tax loss carryforwards, our business, results of operations and financial condition may be adversely affected.
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As a Company active in R&D in Belgium and France, we have benefited from certain R&D incentives including, for example, but not limited to, the Belgian R&D tax credit and the French research tax credit (crédit d’impôt recherche). These tax credits can be offset against Belgian and French corporate income tax due, respectively. The excess portion may be refunded as from the end of a four-year fiscal period for the Belgian R&D incentive (this period of four years is reduced from five years for tax credits carried forward as from the accounting year starting January 1, 2025), and at the end of a three-year fiscal period for the French R&D incentive. As from the accounting year starting January 1, 2025, it is optional for us in Belgium to either apply the tax credit to any corporate income tax due or to carry-over the tax credit to a subsequent taxable period (up to the four-year refund period). The R&D incentives are both calculated based on the amount of eligible R&D expenditure. The Belgian tax credit represented €26.3 million for the year ended December 31, 2023, €17.2 million for the year ended December 31, 2024, and €13.6 million for the year ended December 31, 2025. The French tax credit amounted to €6.5 million for the year ended December 31, 2023, €2.1 million for the year ended December 31, 2024, and nil for the year ended December 31, 2025. The Belgian and/or French tax authorities may audit each R&D program in respect of which a tax credit has been claimed and assess whether it qualifies for the tax credit regime. The tax authorities may challenge our eligibility for, or our calculation of, certain tax reductions and/or deductions in respect of our R&D activities and, should the Belgian and/or French tax authorities be successful in such potential challenges, we may be liable for additional corporate income tax, penalties and interest related thereto, which could have a significant impact on our results of operations and future cash flows. Furthermore, if the Belgian or French governments decide to eliminate or reduce the scope or the rate of the R&D incentive benefits, either of which they could decide to do at any time, our results of operations could be adversely affected.
As a Company active in R&D in Belgium, we also expect to benefit from the innovation income deduction (“IID”), in Belgium. The IID regime allows net profits attributable to revenue from, among others, patented products (or products for which the patent application is pending) to be taxed at a lower effective tax rate than other revenues. The effective tax rate can thus be reduced down to 3.75%. At the end of 2025, we had €692.1 million of carry-forward IID in Belgium.
On December 14, 2022, the Council of the European Union formally adopted the Council Directive on ensuring a global minimum level of taxation for multinational groups in the European Union, laying down rules for ensuring a minimum level of effective corporate taxation of large multinational groups and large-scale purely domestic groups operating in the Single Market. The Council Directive is largely aligned with the OECD Model Rules agreed by the Inclusive Framework and published on December 20, 2021 (the so -called “Pillar II”). The aim of the Council Directive is to realize a 15% global minimum effective tax rate at country-per-country level. At this stage, no carve-out for patent box regimes or R&D incentives is included in the Council Directive. This Council Directive could have an impact on our future effective tax rate and/or tax attributes. Member States had to transpose said Council Directive into their national laws before December 31, 2023.
The Belgian Pillar II rules entered will enter into force in two steps: the income inclusion rule (the “IIR”) and the Qualified Domestic Minimum Top-up Tax (the “QDMTT”) entered into force for taxable periods starting as of December 31, 2023, whereas the rules regarding the Undertaxed Profit Rule (the “UTPR”) have entered into force for taxable periods starting as of December 31, 2024. The legislation will be effective for our financial year beginning on January 1, 2026.
IAS 12 includes a temporary exception to recognizing and disclosing information about deferred tax assets and liabilities that are related to tax law that is enacted or substantively enacted to implement the Pillar 2 legislation. We apply this temporary exception.
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Given our consolidated revenues exceeding 750 MEUR in FY 2023 and FY 2025, we consider that we will become in scope of the Pillar 2 legislation with first reporting year being FY 2026.
We have performed an assessment of our potential exposure to Pillar 2 income taxes using the most recent information available, including FY2024 tax filings and financial statements of us and our constituent entities (the “Galapagos Group”). Based on this assessment, it can be derived that:
(i) In most of the jurisdictions, at least one of the Transitional Country by Country Reporting (“CbCR”) Safe Harbour tests is met.
(ii) In a limited number of jurisdictions where none of the Transitional CbCR Safe Harbour tests is met, we do not expect a material top-up tax exposure in those jurisdictions.
We are preparing to comply with local Pillar 2 requirements for financial years beginning on 1 January 2026.
Our inability to qualify for the abovementioned advantageous tax regimes, as well as the introduction of the minimum taxable base and any other future adverse changes of Belgian tax legislation, may adversely affect our business, results of operations and financial condition.
Our shareholders residing in countries other than Belgium may be subject to double withholding taxation with respect to dividends or other distributions made by us.
Any dividends or other distributions we make to shareholders will, in principle, be subject to withholding tax in Belgium at a rate of 30%, except for shareholders which qualify for an exemption of withholding tax such as, among others, qualifying pension funds, companies qualifying as parent companies in the sense of the Council Directive (90/435/EEC) of July 23, 1990 or the Parent-Subsidiary Directive, as amended, or that qualify for a lower withholding tax rate or an exemption by virtue of a tax treaty. Various conditions may apply, and shareholders residing in countries other than Belgium are advised to consult their advisers regarding the tax consequences of dividends or other distributions made by us. Our shareholders residing in countries other than Belgium may not be able to credit the amount of such withholding tax to any tax due on such dividends or other distributions in any other country than Belgium. As a result, such shareholders may be subject to double taxation in respect of such dividends or other distributions. Belgium and the United States have concluded a double tax treaty concerning the avoidance of double taxation (the “U.S.-Belgium Tax Treaty”). The U.S.-Belgium Tax Treaty reduces the applicability of Belgian withholding tax to 15%, 5% or 0% for U.S. taxpayers that are the beneficial owners of the dividend incomes concerned, provided that such U.S. taxpayers meet the limitation on benefits conditions imposed by the U.S.-Belgium Tax Treaty. The Belgian withholding tax is generally reduced to 15% under the U.S.-Belgium Tax Treaty. The 5% withholding tax applies in cases where the U.S. shareholder, beneficial owner of the income, is a company which holds at least 10% of the voting shares in the company. A 0% Belgian withholding tax applies when the shareholder, beneficial owner of the income, is a U.S. company that has held directly at least 10% of the capital in the company for at least 12 months on the date the dividend is declared, or is, subject to certain conditions, a U.S. pension fund. Our U.S. shareholders are encouraged to consult their own tax advisers to determine whether they can invoke the benefits and meet the limitations on benefits conditions, as imposed by the U.S.-Belgium Tax Treaty.
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Changes in tax law could adversely affect our business and financial condition.
The rules dealing with U.S. federal, state and local taxation and non-U.S. taxation are constantly under review by persons involved in the legislative process, the Internal Revenue Service, the U.S. Treasury Department and other taxing authorities. Changes to tax laws or tax rulings, or changes in interpretations of existing laws (which changes may have retroactive application), could adversely affect us or holders of our ADSs. These changes could subject us to additional income-based taxes and non-income taxes (such as payroll, sales, use, value-added, digital tax, net worth, property, and goods and services taxes), which in turn could materially affect our financial position and results of operations. Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our customers’ and our compliance, operating and other costs, as well as the costs of our products. In recent years, many such changes have been made, and changes are likely to continue to occur in the future. As we expand the scale of our business activities, any changes in the U.S. and non-U.S. taxation of such activities may increase our effective tax rate and harm our business, financial condition, and results of operations.
We believe that we were a PFIC for U.S. federal income tax purposes for the 2025 taxable year and may be a PFIC in the current or subsequent taxable years, which could result in adverse U.S. tax consequences to certain U.S. holders.
Generally, if, for any taxable year, at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a PFIC for U.S. federal income tax purposes. For the purposes of these tests, passive income includes dividends, interest and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. Our status as a PFIC depends on the composition of our income and the composition and value of our assets from time to time. If we are a PFIC any year, certain U.S. holders of the ADSs may suffer adverse tax consequences, including, but not limited to, having gains realized on the sale of the ADSs treated as ordinary income, rather than capital gain, losing the preferential rate applicable to dividends received on the ADSs by individuals who are U.S. holders, and having interest charges apply to distributions by us and the proceeds of sales of the ADSs. For more information, see “Item 10.E.—Taxation—Certain Material U.S. Federal Income Tax Considerations to U.S. Holders—Passive Foreign Investment Company Considerations.”
Based upon the value of our assets, including any goodwill, and the composition of our income and assets, we believe that we were a PFIC for our 2025 taxable year. Additionally, we may be a PFIC in the current taxable year or in any subsequent taxable year. However, our status as a PFIC is a fact-intensive determination made on an annual basis, and we cannot provide any assurances regarding our PFIC status for the current, prior or future taxable years.
We believe that we were not a CFC, for U.S. federal income tax purposes for the 2025 taxable year. If we were to qualify as a CFC, this could result in adverse U.S. federal income tax consequences to certain U.S. holders.
Each “Ten Percent Shareholder” (as defined below) in a non-U.S. corporation that is classified as a CFC for U.S. federal income tax purposes generally is required to include in their income reports for U.S. federal tax purposes such Ten Percent Shareholder’s pro rata share of the CFC’s “Subpart F income” and investment of earnings in U.S. property, even if the CFC has made no distributions to its shareholders.
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Subpart F income generally includes dividends, interest, rents and royalties, gains from the sale of securities and income from certain transactions with related parties. For tax years beginning after December 31, 2017, each Ten Percent Shareholder of a CFC is also required to include in income such Ten Percent Shareholder’s share of “global intangible low-taxed income” with respect to such CFC. In addition, a Ten Percent Shareholder that realizes gain from the sale or exchange of shares in a CFC may be required to classify a portion of such gain as dividend income rather than as a capital gain. A non-United States corporation generally will be classified as a CFC for United States federal income tax purposes if Ten Percent Shareholders own, directly or indirectly, more than 50% of either the total combined voting power of all classes of stock of such corporation entitled to vote or of the total value of the stock of such corporation. A “Ten Percent Shareholder” is a United States person (as defined by the U.S. Internal Revenue Code of 1986, as amended (the “Code”)) who owns or is considered to own 10% or of either (1) the total combined voting power of all classes of stock entitled to vote of such corporation or (2) the total value of all classes of stock of such corporation. The determination of CFC status is complex and includes attribution rules, the application of which is not entirely certain. In addition, recent changes pursuant to United States tax reform to the attribution rules relating to the determination of CFC status may make it difficult to determine our CFC status for any taxable year.
To our best knowledge, we do not believe that we were a CFC for the taxable year ended December 31, 2025. Furthermore, it is possible that our non-United States subsidiaries will be CFCs for the taxable year ended December 31, 2025 (or future taxable years) even if we are not a CFC for such taxable year(s). However, we cannot provide any assurances regarding our status or the status of our subsidiaries as a CFC for the 2025 taxable year or any future taxable years. U.S. holders should consult their own tax advisors with respect to the potential adverse U.S. tax consequences of becoming a Ten Percent Shareholder in a CFC. If we are classified as both a CFC and a PFIC, we generally will not be treated as a PFIC with respect to those U.S. holders that meet the definition of a Ten Percent Shareholder during the period in which we are a CFC.
We may be forced to repay the technological innovation grants if we fail to comply with our contractual obligations under the applicable grant agreements.
We have received several technological innovation grants to date, totaling €38.8 million as of December 31, 2025, from an agency of the Flemish government to support various research programs and technological innovation in Flanders. These grants carry clauses that require us to maintain a presence in the Flemish region for a number of years and invest according to pre-agreed budgets. If we fail to comply with our contractual obligations under the applicable technological innovation grant agreements, we could be forced to repay all or part of the grants received. Such repayment could adversely affect our ability to finance our R&D projects. In addition, we cannot ensure that we will then have the additional financial resources needed or the time or the ability to replace these financial resources with others.
We may be exposed to significant foreign exchange risk.
We hold portions of our cash and cash equivalents and financial investments in currencies other than the euro, in particular, the U.S. dollar. We also incur portions of our expenses and derive revenues, in currencies other than the euro, in particular, the U.S. dollar. As a result, we are exposed to foreign currency exchange risk as our reporting currency is the euro. We engaged in one exchange rate hedging transaction during 2025 to protect against uncertainty in future exchange rates between particular foreign currencies and the euro, but this is not common practice. Therefore, for example (without any limitation), an increase in the value of the euro against the U.S. dollar could be expected to have a negative impact on our revenue and earnings growth as U.S. dollar revenue and earnings, if any, would be translated into euros at a reduced value. We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our business, financial condition, results of operations and cash flows.
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The requirements of being a U.S. public company may strain our resources and divert management’s attention.
We are required to comply with various corporate governance and financial reporting requirements under the Sarbanes-Oxley Act, the Exchange Act and the rules and regulations adopted by the SEC and the U.S. Public Company Accounting Oversight Board (the “PCAOB”), and other applicable securities rules and regulations imposing various requirements on non-United States public companies. Further, compliance with various regulatory reporting requires significant commitments of time from our management and our Directors, which reduces the time available for the performance of their other responsibilities. Our failure to track and comply with the various rules may materially adversely affect our reputation and ability to obtain the necessary certifications to financial statements and may lead to additional regulatory enforcement actions and could adversely affect the value of the ADSs or our ordinary shares. However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
The market price of the ordinary shares and ADSs could be subject to wide fluctuations.
The market price of the ordinary shares and ADSs could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including (without any limitation):
● actual or anticipated fluctuations in our financial condition and operating results;
● actual or anticipated changes in our growth rate relative to our competitors;
● competition from existing products or new products that may emerge;
● announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
● failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
● issuance of new or updated research or reports by securities or industry analysts;
● fluctuations in the valuation of companies perceived by investors to be comparable to us; share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
● additions or departures of key management or scientific personnel;
● disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
● changes to coverage policies or reimbursement levels by commercial third-party payers and government payers and any announcements relating to coverage policies or reimbursement levels;
● announcement or expectation of additional debt or equity financing efforts;
● public concern relating to the commercial value or safety of any of our products or product candidates;
● changes in government regulations;
● positive or negative results of testing and clinical trials by us, strategic partners or competitors;
● outcome of regulatory review of our product candidates;
● sales of the ordinary shares and ADSs by us, our insiders or our other shareholders; and
● general economic and market conditions.
In addition, although the ordinary shares are listed on Euronext Brussels and Euronext Amsterdam, and the ADSs are listed on the Nasdaq Global Select Market stock exchange, we cannot ensure that a trading market for those securities will be maintained.
These and other market and industry factors may cause the market price and demand for the ordinary shares and ADSs to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ordinary shares and ADSs and may otherwise negatively affect the liquidity of our capital shares. In addition, the stock market in general, and biotechnology and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
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We may be at an increased risk of securities class action litigation.
Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant share price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
Share ownership is concentrated in the hands of our principal shareholders and management, which may have the effect of delaying or preventing a change of control of our Company.
As of the date of this annual report on Form 20-F, our executive officers, Directors, current 5% or greater shareholders and their affiliated entities, including Gilead and its affiliates, together beneficially own approximately 54.07% of our ordinary shares, including shares in the form of ADSs. This concentration of ownership might have the effect of delaying or preventing a change of control of our Company that other shareholders may view as beneficial, and might therefore negatively affect the market price of the ADSs. Reference is made to “Item 7.A. – Major Shareholders.”.
Fluctuations in the exchange rate between the U.S. dollar and the euro may increase the risk of holding the ADSs.
Our ordinary shares currently trade on Euronext Brussels and Euronext Amsterdam in euros, while the ADSs trade on Nasdaq in U.S. dollars. Fluctuations in the exchange rate between the U.S. dollar and the euro may result in temporary differences between the value of the ADSs and the value of our ordinary shares, which may result in heavy trading by investors seeking to exploit such differences.
In addition, as a result of fluctuations in the exchange rate between the U.S. dollar and the euro, the U.S. dollar equivalent of the proceeds that a holder of the ADSs would receive upon the sale on Euronext Brussels or Euronext Amsterdam of any ordinary shares withdrawn from the depositary and the U.S. dollar equivalent of any cash dividends paid in euros on our shares represented by the ADSs could also decline.
If securities or industry analysts do not publish research or publish inaccurate research or unfavorable research about our business, the price of the ordinary shares and ADSs and trading volume could decline.
The trading market for the ordinary shares and ADSs depends in part on the research and reports that securities or industry analysts publish about us or our business. If no or few securities or industry analysts cover our Company, the trading price for the ordinary shares and ADSs would likely be negatively impacted. If one or more of the analysts who covers us downgrades the ordinary shares and ADSs or publishes incorrect or unfavorable research about our business, the price of the ordinary shares and ADSs would likely decline. If one or more of these analysts ceases coverage of our Company, fails to publish reports about us regularly or downgrades the ordinary shares and ADSs, demand for the ordinary shares and ADSs could decrease, which could cause the price of the ordinary shares and ADSs or trading volume to decline.
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We have no present intention to pay dividends on our ordinary shares in the foreseeable future and, consequently, shareholders’ only opportunity to achieve a return on their investment during that time is if the price of the ordinary shares and ADSs appreciates.
We have no present intention to pay dividends in the foreseeable future. Even if future operations lead to significant levels of distributable profits, we currently intend that any and all earnings will be reinvested in our business. Any proposal by our Board of Directors to pay dividends or to take other actions, which could include share buybacks, instead of or in addition to the declaration of dividends, will depend on many factors, including our financial condition (including losses carried forward), results of operations, legal requirements, contractual obligations, business prospects, cash requirements, new product development and other factors. Furthermore, pursuant to Belgian law, the calculation of amounts available for distribution to shareholders as dividends, or otherwise, must be determined on the basis of our non-consolidated statutory accounts prepared in accordance with Belgian accounting rules and Belgian generally accepted accounting principles, as used by us in the preparation of these accounts. In addition, in accordance with Belgian law and our articles of association (the “Articles of Association”), we must allocate each year an amount of at least 5% of our annual net profit under our non-consolidated statutory accounts to a legal reserve until such legal reserve equals 10% of our share capital. Therefore, we are unlikely to pay dividends or other distributions in the foreseeable future. If the price of the ordinary shares and ADSs declines before we pay dividends, shareholders will incur a loss on their investment, without the likelihood that this loss will be offset in part or at all by potential future cash dividends. Accordingly, investors cannot rely on cash dividend income from ordinary shares and ADSs, and any returns on an investment in the ordinary shares and ADSs will likely depend entirely upon any future appreciation in the price of the ordinary shares and ADSs.
We are a Belgian public limited liability company, and shareholders of our Company may have different and in some cases more limited shareholder rights than shareholders of a U.S. listed corporation.
We are a public limited liability company incorporated under the laws of Belgium. Our corporate affairs are governed by Belgian corporate law and our Articles of Association. The rights provided to our shareholders under Belgian corporate law and our Articles of Association may differ in certain respects from the rights that one would typically enjoy as a shareholder of a U.S. corporation under applicable U.S. federal and state laws.
Under Belgian corporate law, other than certain limited information that we must make public and except in certain limited circumstances, our shareholders may not ask for an inspection of our corporate records, while under Delaware corporate law, any shareholder, irrespective of such shareholder’s holdings, may do so. Shareholders of a Belgian corporation are also unable to initiate a derivative action, a remedy typically available to shareholders of United States companies in order to enforce rights of our Company, in case we fail to enforce such rights ourselves, other than in certain cases of director liability under limited circumstances. In addition, a majority of our shareholders present or represented at our shareholders’ meetings may release a member of our Board of Directors from any claim of liability we may have, including if he or she has acted in bad faith or has breached his or her duty of loyalty, provided, in some cases, that the relevant acts were specifically mentioned in the convening notice to the Shareholders’ Meeting deliberating on the discharge. In contrast, most U.S. federal and state laws prohibit a company from releasing a director from liability altogether if he or she has acted in bad faith or has breached his or her duty of loyalty to the company. Finally, Belgian corporate law does not provide any form of appraisal rights in the case of a business combination. For more information, please see the section of this annual report titled “Item 10.B.— Memorandum and Articles of Association.”
The responsibilities of members of our Board of Directors may be different from those in companies governed by U.S. laws. In the performance of its duties, our Board of Directors is required by Belgian law to consider the interests of our Company, in all cases with due observation of the principles of reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, shareholders’ interests.
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As a result of these differences between Belgian corporate law and our Articles of Association, on the one hand, and the U.S. federal and state laws, on the other hand, in certain instances, shareholders could receive less protection as an ADS holder of our Company than they would as shareholders of a listed U.S. company.
Takeover provisions in Belgian law may make a takeover difficult.
Public takeover bids on our ordinary shares and other voting securities, such as subscription rights or convertible bonds, if any, are subject to the Belgian Act of April 1, 2007, as amended (the “Belgian Act”), and to the supervision by the Belgian Financial Services and Markets Authority (“FSMA”). Public takeover bids must be made for all of our voting securities, as well as for all other securities that entitle the holders thereof to the subscription to, the acquisition of or the conversion into voting securities. Prior to making a bid, a bidder must issue and disseminate a prospectus, which must be approved by the FSMA. The bidder must also obtain approval of the relevant competition authorities, where such approval is legally required for the acquisition of our Company.
The Belgian Act, provides that a mandatory bid will be triggered if a person, as a result of its own acquisition or the acquisition by persons acting in concert with it or by persons acting on their account, directly or indirectly, holds more than 30% of the voting securities in a company that has its registered office in Belgium and, of which, at least part of the voting securities are traded on a regulated market or on a multilateral trading facility designated by the Royal Decree of April 27, 2007, as amended, on public takeover bids. The mere fact of exceeding the relevant threshold through the acquisition of one or more shares will give rise to a mandatory bid, irrespective of whether or not the price paid in the relevant transaction exceeds the current market price.
There are several provisions of Belgian corporate law and certain other provisions of Belgian law, such as the obligation to disclose important holdings and merger control, that may apply to us and which may make an unfriendly tender offer, merger, change in management or other change in control more difficult. These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the opportunity to sell their ordinary shares at a premium (which is typically offered in the framework of a takeover bid). These provisions may also have the effect of depriving ADS holders of the opportunity to sell their ADSs potentially at a premium.
Holders of the ADSs are not treated as shareholders of our Company, do not have the same voting rights as the holders of our ordinary shares and may not receive voting materials in time to be able to exercise their right to vote.
Holders of the ADSs are not treated as shareholders of our company, unless they withdraw our ordinary shares underlying the ADSs in accordance with the deposit agreement and applicable laws and regulations. The depositary, or its nominee, is the holder of the ordinary shares underlying the ADSs. Holders of ADSs therefore do not have any rights as shareholders of our Company, other than the rights that they have pursuant to the deposit agreement.
Holders of ADSs may exercise voting rights attached to the ordinary shares represented by the ADSs only in accordance with the provisions of the deposit agreement. The deposit agreement provides that, upon receipt of notice of any meeting of holders of our ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the exercise of voting rights. Upon timely receipt of notice from us, if we so request, the depositary shall distribute to the holders as of the record date (1) the notice of the Shareholders Meeting or solicitation of consent or proxy sent by us and (2) a statement as to the manner in which instructions may be given by the holders.
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Holders of ADSs may instruct the depositary of their ADSs to vote the ordinary shares underlying their ADSs. Otherwise, ADS holders will not be able to exercise their right to vote, unless they withdraw the ordinary shares underlying the ADSs they hold. However, ADS holders may not know about the meeting far enough in advance to withdraw those ordinary shares. We cannot guarantee to ADS holders that they will receive the voting materials in time to ensure that they can instruct the depositary to vote their ordinary shares or to withdraw their ordinary shares so that they can vote them themselves. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that ADS holders may not be able to exercise their right to vote, and there may be nothing they can do if the ordinary shares underlying their ADSs are not voted as they requested.
We may not be able to complete equity offerings without cancellation or limitation of the preferential subscription rights of our existing shareholders, which may as a practical matter preclude us from timely completion of offerings.
In accordance with the Belgian Code of Companies and Associations (the “BCCA”), our Articles of Association provide for preferential subscription rights to be granted to our existing shareholders to subscribe on a pro rata basis and in exchange for contributions in cash, for any issue of new shares, convertible bonds or subscription rights that, unless such rights are cancelled or limited either by resolution of our Shareholders’ Meeting or by our Board of Directors in the framework of the authorized capital, as described below. The Extraordinary Shareholders’ Meeting authorized the Board of Directors to increase our share capital, in one or several times, and under certain conditions set forth in extenso in our Articles of Association. We refer to this authority for our Board of Directors to increase our share capital as our authorized capital. This authorization consists of two parts, a general authorization for capital increases and a specific authorization for capital increases, and said authorizations can be renewed. The general authorization for capital increases up to 20% of the share capital at the time of convening the EGM of April 30, 2024 (i.e., €71,288,987.72) was renewed and is valid for a period of five years from the date of publication of such renewal in the Annexes to the Belgian State Gazette, i.e., May 7, 2024, so until May 7, 2029. Said renewed general authorization for capital increases replaced the previous general authorization which was approved at the EGM held on October 22, 2019 (i.e., €67,022,402.04) and published in the Annexes to the Belgian State Gazette on November 13, 2019. A specific authorization for capital increases of more than 20% and up to 33% of the share capital at the time of the convening the EGM of April 25, 2017 (i.e., € 82,561,764.93) was renewed and was valid for a period of five years from the date of publication of this renewal in the Annexes to the Belgian State Gazette, i.e., May 31, 2017, so until May 30, 2022. This specific part of the authorized capital was, however, only able to be used in a number of specific circumstances and upon a resolution of the Board of Directors that all its independent members within the meaning of article 7:87 of the BCCA approve. This specific authorization was not renewed in 2022. As of the date of this annual report, our Board of Directors may decide to issue up to 9,071,262.06 ordinary shares pursuant to the general authorization. For more information, please see the section of this annual report titled, “Item 10.B.—Memorandum and Articles of Association.” Absent renewal by our shareholders of this authorization of the Board of Directors or absent cancellation or limitation by our shareholders of the preferential subscription rights of our existing shareholders, the requirement to offer our existing shareholders the preferential right to subscribe, pro rata, for new shares being offered may, as a practical matter, preclude us from timely capital raising on commercially acceptable terms or at all.
Shareholders may not be able to participate in equity offerings we may conduct from time to time.
If we conduct equity offerings in the future, certain shareholders, including those in the United States, may, even in the case where preferential subscription rights have not been cancelled or limited, not be entitled to exercise such rights, unless the offering is registered or the shares are qualified for sale under the relevant regulatory framework. As a result, there is the risk that investors may suffer dilution of their holdings should they not be permitted to participate in preference right equity or other offerings that we may conduct in the future.
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Holders of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying ordinary shares.
ADSs are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement or for any other reason, subject to the right of ADS holders to cancel their ADSs and withdraw the underlying ordinary shares. Temporary delays in the cancellation of holders’ ADSs and their withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books, we have closed our transfer books, the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares. In addition, ADS holders may not be able to cancel their ADSs and withdraw the underlying ordinary shares when they owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.
As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of ADSs or our ordinary shares.
We are a “foreign private issuer,” as defined in the SEC’s rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to public companies organized within the United States. For example (without any limitation), we are exempt from certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our officers and Directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we currently make annual and semi-annual filings with respect to our listing on Euronext Brussels and Euronext Amsterdam and voluntarily report our results of operations on a quarterly basis via a press release or a financial report, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. domestic issuers and will not be required to file quarterly reports on Form 10-Q or current reports on Form 8-K under the Exchange Act. Accordingly, there is and will continue to be less publicly available information concerning our Company than there would be if we were not a foreign private issuer.
As a foreign private issuer, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance listing standards. These practices may afford less protection to shareholders than they would enjoy if we complied fully with corporate governance listing standards.
As a foreign private issuer listed on the Nasdaq Global Select Market, we are subject to corporate governance listing standards. However, rules permit a foreign private issuer like us to follow the corporate governance practices of its home country. Certain corporate governance practices in Belgium, which is our home country, may differ significantly from corporate governance listing standards applicable to U.S. domestic issuers. For example (without any limitation), neither the corporate laws of Belgium nor our Articles of Association require a majority of the members of our Board of Directors to be independent, and we can include non-independent Board members as members of our Nomination Committee and Remuneration Committee, and our independent Board members would not necessarily hold regularly scheduled meetings at which only independent Board members are present. Currently, we intend to follow home country practices to the maximum extent possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing standards applicable to U.S. domestic issuers. See the sections of this annual report titled “Item 6—Directors, Senior Management and Employees” and “Item 16G —Corporate Governance.”
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We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.
While we currently qualify as a foreign private issuer, and, therefore, we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act that are applicable to U.S. domestic issuers, the determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, the next determination will be made with respect to us on June 30, 2026.
In the future, we would lose our foreign private issuer status if we were to fail to meet the requirements necessary to maintain our foreign private issuer status as of the relevant determination date. In order to maintain our current status as a foreign private issuer, either (a) a majority of our ordinary shares must be either directly or indirectly owned of record by non-residents of the United States or (b) (i) a majority of our executive officers or Directors may not be U.S. citizens or residents, (ii) more than 50% of our assets cannot be located in the United States and (iii) our business must be administered principally outside the United States. As of March 15, 2026, while a majority of our Directors are not U.S. citizens or residents, the majority of our executive officers are U.S. citizens or residents.
The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly more than costs we incur as a foreign private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time-consuming and costly. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), rather than the International Financial Reporting Standards, in U.S. dollars rather than euros and to modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion of our financial statements to U.S. GAAP will involve significant time and cost. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers such as the ones described above and exemptions from procedural requirements related to the solicitation of proxies.
It may be difficult for investors outside Belgium to serve process on, or enforce foreign judgments against, us or our Directors and senior management.
We are a Belgian public limited liability company. Less than a majority of the members of our Board of Directors and members of our Executive Committee are residents of the United States. All or a substantial portion of the assets of such non-resident persons and most of our assets are located outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or on us or to enforce against them or us a judgment obtained in U.S. courts. Original actions or actions for the enforcement of judgments of U.S. courts relating to the civil liability provisions of the federal or state securities laws of the United States (as amended from time to time) are not directly enforceable in Belgium. The United States and Belgium do not currently have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards, in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in Belgium. This will depend on the applicable Belgian national rules.
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In order for a final and conclusive judgment rendered by U.S. courts based on civil liability to produce any effect on Belgian soil, it is accordingly required that this judgment be recognized or be declared enforceable by a Belgian court in accordance with Articles 22 to 25 of the 2004 Belgian Code of Private International Law, as amended. Recognition or enforcement does not imply a review of the merits of the case and is irrespective of any reciprocity requirement. A U.S. judgment will, however, not be recognized or declared enforceable in Belgium if it infringes upon one or more of the grounds for refusal that are exhaustively listed in Article 25 of the Belgian Code of Private International Law, as amended. Actions for the enforcement of judgments of U.S. courts might be successful only if the Belgian court confirms the substantive correctness of the judgment of the U.S. court and if it is satisfied that:
● the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy;
● the judgment did not violate the rights of the defendant;
● the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law;
● the judgment is not subject to further recourse under U.S. law;
● the judgment is not compatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be enforced in Belgium;
● a claim was not filed outside of Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending;
● the Belgian courts did not have exclusive jurisdiction to rule on the matter;
● the U.S. court did not accept its jurisdiction solely on the basis of either the nationality of the defendant or the location of the disputed goods; and
● the judgment submitted to the Belgian court is authentic.
Under the Belgian Code of Private International law, in addition to recognition or enforcement and before a Belgian court, a judgment by a federal or state court in the United States against us may also serve as evidence in a similar action in a Belgian court if it meets the conditions required for the authenticity of judgments according to the law of the state where it was rendered. The findings of a federal or state court in the United States will not, however, be taken into account to the extent they appear to be incompatible with Belgium’s (international) public policy.
U.S. judgments ordering to pay a certain amount that are declared enforceable in Belgium are subject to the applicable registration taxes in the same way as Belgian judgments. As such, a registration tax at the rate of 3% of the amount awarded is payable by the debtor(s) if the sum of money exceeds EUR 12,500. If multiple debtors were held jointly liable to pay, the debtors are also jointly liable to pay the registration tax.
In light of the above, U.S. investors may not be able to enforce against us, or members of our Board of Directors or members of our Executive Committee who are residents of Belgium or countries other than the United States any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws (as amended from time to time).
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