B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
Summary
Our business is subject to numerous risks and uncertainties. You should carefully consider these risks and uncertainties
when investing in our ordinary shares or American depositary shares (“ADSs”). The principal risks and uncertainties
affecting our business include the following:
•The substantial majority of our revenue comes from royalties on sales of DARZALEX, and our patents underlying
these royalties will start to expire in the late 2020s.
•Our launch of a new product or of an existing product in a new indication or territory is subject to a number of
risks and uncertainties and may not be successful.
•Our business and operations have experienced rapid growth that needs to be carefully managed.
•We may acquire businesses or products, form collaborations or enter into other strategic transactions in the future,
but we may not realize their benefits, and we may need to raise additional capital to fund these transactions.
•Sales of our products will depend on the degree of market acceptance by physicians, patients, healthcare payers
and others in the medical community.
•We rely on our collaboration partners in many aspects of our business.
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•We rely on third parties to conduct clinical trials.
•We rely on a limited number of third-party manufacturers for our product supply.
•Biopharmaceutical product development involves a substantial degree of uncertainty.
•Our product candidates will need to undergo clinical trials that are time-consuming and expensive, the outcomes
of which are unpredictable, and for which there is a high risk of failure.
•Any approval granted for our products or product candidates in the US does not assure approval of such products
in Japan and the EU or other foreign jurisdictions.
•We may be affected by reports of adverse events or safety concerns relating to our products or product candidates.
•We may face product liability claims related to the use or misuse of our products or technologies.
•Our business applications and information technology (“IT”) infrastructure, or those of our collaboration partners,
contractors or consultants, may fail or suffer cyber security breaches, and the use of novel technologies may
subject us to additional risks.
•Our ability to compete may decline if we or our collaboration partners are unable to or do not adequately protect
intellectual property rights or if our intellectual property rights are inadequate.
•Government restrictions on pricing and reimbursement, as well as other healthcare payer cost-containment
initiatives, may negatively impact our ability to generate revenue.
•Even if approved, our products will be subject to extensive post-approval regulation, which may result in
significant additional expense. 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.
•Future laws and regulations and changes to existing ones may have an adverse impact on our business.
•We and our business arrangements with third parties are subject to fraud, abuse and other healthcare laws and
regulations.
•We may not realize the anticipated benefits from the acquisition of Merus.
•Our substantial indebtedness could adversely affect our financial condition.
Risks Related to Our Business and Financial Condition
The substantial majority of our revenue comes from royalties on sales of DARZALEX, and our patents underlying these
royalties will start to expire in the late 2020s.
In 2025, royalties from Johnson & Johnson (“J&J”), legal entity Janssen Biotech, Inc., related to daratumumab
(marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the US and as DARZALEX SC in
Europe for subcutaneous (“SC”) administration) for certain indications of multiple myeloma (“MM”) and light-chain
(“AL”) amyloidosis, accounted for 66% of our revenue. We anticipate that DARZALEX will continue to account for a
substantial portion of our revenue in the near term. J&J is currently fully responsible for developing and commercializing
daratumumab, and all costs associated therewith, and consequently, our revenue and resulting operating profit and near-
term prospects are substantially dependent on J&J’s efforts and the success of this collaboration.
The royalties payable to us by J&J are limited in time and subject to reduction on a country-by-country basis for
customary reduction events, including for lack of patent coverage or upon patent expiration or invalidation in the relevant
country and upon the first commercial sale of a biosimilar product in the relevant country (for as long as the biosimilar
product remains for sale in that country). Pursuant to the terms of the agreement, J&J’s obligation to pay royalties to us will
expire on a country-by-country basis on the later of the date that is 13 years after the first sale of daratumumab in such
country or upon the expiration or invalidation of the last-to-expire relevant Genmab patent covering daratumumab in such
country. The first US, European and Japanese sales of daratumumab occurred in 2015, 2016 and 2017, respectively.
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We have issued patents and pending patent applications covering daratumumab in numerous jurisdictions, including
patents issued in the US, Europe and Japan. J&J owns a separate patent portfolio related to the SC formulation of
daratumumab used in DARZALEX FASPRO/DARZALEX SC, but a binding arbitration determined that we are not
entitled to royalties based on these separate patents.
Our issued US, European and Japanese patents covering daratumumab, after giving effect to issued US, European and
Japanese patent term extensions (“PTEs”) and supplementary protection certificates (“SPCs”), expire in 2029, 2031 and
begin to expire in 2030, respectively. Assuming constant underlying sales of DARZALEX, we expect that our royalties
from sales of DARZALEX will begin to decline materially in 2029 following expiration of our US patent rights on
daratumumab. There can be no assurance that we will be able to replace all or any portion of lost DARZALEX royalty
revenues through development and commercialization of other products or through acquisitions in a timely manner or at
all.
In addition, there can be no assurance that DARZALEX sales will remain at or near current levels or will continue to
grow while we remain entitled to royalties. In particular, DARZALEX is subject to intense competition in the MM therapy
market. In addition to numerous other US Food and Drug Administration (“FDA”) approved treatments for the same
indications, we are also aware of several additional investigational agents and technologies that are currently being studied
for the treatment of MM, any of which may compete with DARZALEX in the future. If DARZALEX is unable to
successfully compete with these or other agents and technologies, DARZALEX sales could decline materially.
Future prospects for daratumumab are subject to the risks outlined below with respect to our other product candidates,
including risks related to clinical trials, adverse events, regulatory requirements and approvals, intellectual property
matters, competition, manufacturing, pricing, reimbursement and marketing. In addition, future prospects for daratumumab
are also subject to the risk that we will be unable to successfully manage our relationship with J&J and other risks
described herein that are applicable to all our collaborations.
Our launch of a new product or of an existing product in a new indication or territory is subject to a number of risks
and uncertainties and may not be successful.
We are continuing to expand our commercialization capabilities, including sales, distribution and marketing, to allow
us to market our own products for the indications and in the geographies we determine would be most effective to create
value for patients and our shareholders. The continued commercialization of our existing products could be impaired, and
the launch and commercialization of any future products could be delayed or impaired, due to a variety of factors,
including supply constraints, delays or challenges in arranging a commercial infrastructure, delays in obtaining or failure to
obtain pricing and reimbursement approvals, or other factors, including those described elsewhere herein.
We continue to grow our market-based commercialization operations in existing and additional new markets. Building
comprehensive commercialization capabilities requires substantial investment of time and money and significant
management focus and resources. We are competing with pharmaceutical and biotechnology companies with established
commercialization and marketing capabilities. Without appropriate leveraging of our internal existing team or the support
of third parties, we may be unable to compete successfully against these more established companies as we expand into
new territories. In addition, we may be unable to develop productive relationships with local medical experts, patients and
other key stakeholders or may face barriers due to cultural or regulatory differences. We also compete for staffing with
transnational and local pharmaceutical and biotechnology firms and local medical, healthcare and research organizations.
Accordingly, there can be no assurance that our efforts to build and expand comprehensive commercialization capabilities
will be successful in an acceptable timeframe, without disproportionately substantial expenses or at all.
Even if more of our proprietary product candidates obtain regulatory approval, we may determine that
commercializing such product candidates ourselves would not be the most effective way to create value for our
shareholders. In addition, if we choose to commercialize any of our product candidates, our marketing efforts may be
unsuccessful as a result of unfavorable pricing or reimbursement limitations, delays, competition or other factors. We are
also subject to extensive and costly government regulation and are required to obtain and maintain governmental approvals
in order to successfully commercialize our products. Failure to successfully market one or more of our approved products,
or delays in our commercialization efforts, may diminish the commercial prospects for such products and may result in
financial losses or damage to our reputation, each of which may have a negative impact on our financial condition, results
of operations and future growth prospects.
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Our business and operations have experienced rapid growth that needs to be carefully managed.
We have experienced rapid growth over the last several years, and we anticipate further growth as our pipeline
advances and we further commercialize our products. Since 2019 Genmab has grown from 548 employees to 3,029 at the
end of 2025. In 2019, there were 12 active industry sponsored clinical trials for Genmab proprietary products, which are
those owned at least 50% by Genmab. By the end of 2025, this number had more than doubled to 30, including nine Phase
III trials, not including trials initiated by Merus. With the acquisition of Merus we added petosemtamab to our pipeline,
including two additional Phase III trials and two Phase II trials. Such growth has put significant demands on our
management and infrastructure, including new operational and financial systems, expanding commercial capabilities, as
well as extended manufacturing and commercial outsourcing arrangements. Our success will depend in part upon our
ability to manage this growth effectively, including by maintaining our collaborative culture. As we continue to grow, we
must continuously improve our operational, financial and management controls and our reporting systems and procedures.
We must ensure that our policies and procedures evolve to reflect our dynamic operating model and implementation of
financial systems. We must also continue to effectively retain existing employees and to attract, hire, train and retain new
employees. Any failure to expand these areas and implement appropriate procedures and controls in an efficient manner
and at a pace consistent with our business objectives could have a material adverse effect on our business, financial
condition, results of operations and cash flows.
We may acquire businesses or products, form collaborations or enter into other strategic transactions in the future, but
we may not realize their benefits, and we may need to raise additional capital to fund these transactions.
Should attractive opportunities arise, we may acquire companies or technologies, form collaborations or enter into
other strategic transactions that facilitate our access to new products, research projects or geographical areas, or that enable
us to achieve synergies with our existing operations. However, we may not be able to identify appropriate targets, make
acquisitions or form collaborations under satisfactory financial and other conditions. If we acquire or enter into
collaborations or other strategic transactions with businesses, we may not be able to realize the benefits of such acquisitions
or collaborations, including if we are unable to successfully integrate them with our existing operations and company
culture, or if we encounter difficulties in developing, receiving regulatory approval for, manufacturing and marketing any
new products resulting from such acquisitions, collaborations or transactions. The inability to achieve the expected benefits
of any such transaction, including if the products acquired as part of recent transactions, Rina-S and petosemtamab, should
be significantly delayed or fail, could have a material adverse effect on our business, financial condition, results of
operations, debt repayments and future growth prospects and our investors’ ability to realize on their investments.
In addition, we may need to seek additional funds to finance such transactions, and we may be unable to obtain
financing on favorable terms, in a timely manner or at all. Our ability to raise additional funds may be adversely impacted
by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets
in the US and worldwide resulting from factors that include but are not limited to, actual or threatened trade restrictions and
tariffs, trade tensions, inflation, wars and geopolitical conflicts and tensions, including the conflict between Russia and
Ukraine and conflicts in the Middle East, diminished liquidity and credit availability, declines in consumer confidence,
declines in economic growth, increases in unemployment rates, uncertainty about economic stability, increases in interest
rates and potential for economic recession. If the equity and credit markets deteriorate, it may make any necessary debt or
equity financing more difficult, more costly and more dilutive. If we are unable to raise capital or if the cost is prohibitively
expensive, we may need to finance transactions using cash and cash equivalents and marketable securities that could
otherwise be allocated to other purposes in the context of our existing operations, and in hindsight our allocation decisions
may not be optimal.
Sales of our products will depend on the degree of market acceptance by physicians, patients, healthcare payers and
others in the medical community.
If any of our product candidates receive marketing approval or if any of our marketed products receive marketing
approval for additional indications, they may nonetheless fail to gain sufficient market acceptance by physicians, patients,
healthcare payers and others in the medical community, due to not being as well-established or known as conventional
therapies or otherwise. Accordingly, our commercial opportunity may be limited and/or our revenues from sales of these
products may be negatively impacted. The degree of market acceptance will depend on a number of factors, including: the
price, efficacy, safety, convenience and ease and safety of administration of such products, along with their competitive
advantages vis-à-vis other therapies, designation as a first-, second- or third-line treatment, changes in the relevant standard
of care or clinical guidelines and any labeling restrictions or warnings, the willingness of the target patient population to try
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and of physicians to prescribe our products, the availability and amount of coverage and reimbursement from government
payers, managed care plans and other third-party payers, and the strength of the sales, marketing and distribution support
provided by us or our collaboration partners.
We may not meet publicly announced product development objectives.
We sometimes estimate for planning purposes the timing of the accomplishment of various scientific, clinical,
regulatory and other product development objectives. These milestones may include our expectations regarding the
commencement or completion of scientific trials or clinical trials, the submission of regulatory filings or the achievement
of commercialization objectives. From time to time, we may publicly announce the expected timing of some of these
milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of
marketing approval or a commercial launch of a product. The achievement of many of these milestones is outside of our
control. All of these milestones are based on a variety of assumptions, which may cause the timing of achievement of the
milestones to vary considerably from our estimates. If we fail to achieve announced milestones in the timeframes we
expect, or at all, it may have a material adverse effect on our business, financial condition and results of operations and the
price of our ADSs may be adversely affected.
Our target patient population may be lower than our estimates and we may be unable to recoup our development
investments.
Periodically, we and our collaboration partners make estimates regarding the incidence and prevalence of target patient
populations for particular diseases based on various sources and internally generated analysis and use such estimates in
making decisions regarding product development strategy, including determining indications on which to focus in
preclinical or clinical trials. These estimates may be inaccurate or based on imprecise data, or patient incidence and
prevalence for selected indications may evolve over time as treatments and patient outcomes change. The number of
patients in the addressable markets may turn out to be lower than expected, patients may not be otherwise amenable to
treatment with our products, or new patients may become increasingly difficult to identify or gain access to.
Even if our product candidates obtain significant market share for their approved indications, because certain potential
target populations are small, we may never recoup our investment in such product candidates without obtaining regulatory
approval for additional indications for such product candidates. We expect that we or our collaboration partners will
initially seek approval of some of our product candidates as second- or third-line therapies for patients who have failed
other approved treatments, which further limits the size of the potential patient population for such indication. If we or our
collaboration partners are unable to obtain regulatory approval for such products for frontline or second-line therapy, we
may be unable to recoup our investment in such products.
We are exposed to foreign exchange risk.
Most of our financial transactions are made in US dollars, DKK and Euro. As of January 1, 2025 we changed our
reporting currency to US dollars and, as a result, we currently experience exchange rate risk with respect to our holdings
and transactions denominated in currencies other than US dollars. Our currency exposure is mainly related to cash deposits,
marketable securities, and accounts payable denominated in currencies other than US dollars.
If we fail to manage our foreign exchange risk adequately, our business, financial condition, results of operations and
future growth prospects and the value of our ADSs may be adversely affected.
We are subject to risks as a result of our multinational operations.
We, our collaborators and third-party partners and suppliers operate in many jurisdictions around the world and as a
result could be adversely affected by risks and uncertainties associated with such multinational operations, including,
among others: capital and exchange controls; local and global economic conditions including inflation, recession, volatility
and/or lack of liquidity in capital markets; expropriation and other restrictive government actions; actual or threatened trade
restrictions or tariffs such as the sweeping tariffs announced by the US in 2025 and the trade tensions between US and
China; trade regulations; tax laws and regulations; and procedures and actions affecting approval, production, pricing, and
marketing of, reimbursement for and access to our products, as well as impacts of political or civil tensions, unrest or
military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and their economic
consequences; geopolitical instability; terrorist activity; unstable governments and legal systems; and inter-governmental
disputes and tensions. Some emerging market countries may be particularly vulnerable to periods of financial, economic or
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political instability, weakening of the rule of law, or significant currency fluctuations. Local economic and political
conditions may adversely affect our distributors, customers, suppliers, collaborators and service providers, and their ability
to perform their obligations under agreements with us.
Risks Related to Partners and Other Third Parties
We rely on our collaboration partners in many aspects of our business.
We rely on our collaboration partners in many aspects of our business, including to assist with, or to conduct, clinical
and regulatory development, manufacturing and/or commercialization of certain of our partnered and proprietary products
and product candidates or to provide access to antigens, technologies, skills and information that we do not possess.
If we are not able to maintain our existing material collaborations (or replace them if terminated), establish additional
collaborations on favorable terms or realize the anticipated benefits from our collaborations, our business, financial
condition and results of operations may be materially harmed. In particular, the termination of any of our key
collaborations could significantly delay the development and commercialization of our products and product candidates
and impact our financial results and future prospects. Our licensing collaboration partners generally have the right to
terminate our collaborations with notice at any time. Our ability to continue our current collaborations and to enter into
additional ones will depend in large part on whether we are able to successfully maintain, expand and demonstrate our
research, development and commercialization capabilities and the benefits of our technologies relative to those of our
competitors.
We also rely on our collaboration partners to periodically provide us with information about the status, progress and
results of clinical trials and regulatory processes that they are conducting, sponsoring, or pursuing with respect to products
that are the subject of the collaboration. For products and product candidates being developed by our collaboration
partners, we generally do not have direct access to the underlying data or direct communications with the relevant
regulators. As a result, our knowledge of material clinical events or data or material regulatory communications or
developments, and our corresponding ability to report these to our shareholders, may be limited or delayed.
In addition, our reliance on our collaboration partners subjects us to a number of additional risks, including the
following:
•our collaboration partners have significant discretion regarding whether and on what timeline to pursue planned
activities;
•we cannot control the quantity and nature of the resources our collaboration partners may devote to the
development, commercialization, marketing and distribution of products or product candidates;
•our collaboration partners may not develop products generated using our antibody technology as expected;
•disputes between us and our collaboration partners may delay or terminate the research, development or
commercialization of the applicable products and product candidates or result in costly litigation or arbitration that
diverts management’s attention and resources;
•with respect to collaborations under which we have an active role, we and our collaboration partners may have
differing opinions or priorities, or we may encounter challenges in joint decision making, which may delay or
terminate the research, development or commercialization of the applicable products and product candidates;
•we may not receive milestone payments from our collaboration partners, at the expected time or at all, if our
collaboration partners do not achieve future milestones or if we and our collaboration partners disagree about
whether a milestone has been reached;
•our collaboration partners may require, terminate or repeat clinical trials or require a new formulation of a product
candidate for clinical testing, or may abandon a product candidate;
•our relationships with our collaboration partners may divert significant time and effort of our scientific staff and
management team;
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•our collaboration partners may be subject to regulatory sanctions that could adversely affect the development,
approval or commercialization of the applicable products or product candidates;
•our collaboration partners may not properly maintain or defend relevant intellectual property rights, or may
infringe the intellectual property rights of third parties, or may use our or third parties’ proprietary information in
such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to
potential litigation;
•our collaboration partners may develop competing products, therapeutic approaches or technologies;
•business combinations, financial difficulties, strategic transactions, or significant changes in a collaboration
partner’s business strategy or as a result of changes in political or economic conditions, may adversely affect that
collaboration partner’s willingness or ability to continue to pursue our products or product candidates and make
payments under collaboration agreements to us when due; and
•our collaborations may be terminated, breached, or allowed to expire, or our collaboration partners may reduce the
scope of our agreements with them.
Any one or more of the foregoing risks, if realized, could have a material adverse effect on our business, financial
condition and results of operations.
We rely on third parties to conduct clinical trials.
We rely on third parties, such as CROs, to conduct clinical trials on product candidates we are developing. Our
collaboration partners may similarly rely on such parties. The third parties with whom we and our collaboration partners
contract for execution of our or their clinical trials play a significant role in the conduct of these trials and the subsequent
collection and analysis of data. These third parties are not our employees and, except for restrictions imposed by our
contracts with such third parties, we have limited ability to control the amount or timing of resources that they devote to
our programs. Although we rely on these third parties to conduct clinical trials, we remain responsible for ensuring that
each of our clinical trials is conducted in accordance with its investigational plan and protocol and in compliance with
applicable regulations and standards, commonly referred to as GCPs.
If the third parties conducting our clinical trials do not perform their contractual duties or obligations, experience work
stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or
accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or to
GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties. This could be
costly, and our clinical trials may need to be extended, delayed, terminated or repeated. We may not be able to obtain
regulatory approval in a timely fashion, or at all, for the applicable product candidate, or to commercialize such product
candidate being tested in such trials.
We rely on a limited number of third-party manufacturers for our product supply.
To ultimately be successful, our antibody products must be manufactured in commercial quantities in compliance with
regulatory requirements and at acceptable costs. J&J is responsible for the manufacture of daratumumab, amivantamab,
teclistamab and talquetamab. Novartis International AG (“Novartis”) is responsible for the manufacture of ofatumumab,
Amgen Inc. (“Amgen”) is responsible for the manufacture of teprotumumab, AbbVie is responsible for the manufacturing
of epcoritamab, and Pfizer Inc. (“Pfizer”) is responsible for the manufacturing of tisotumab vedotin.
For the product candidates we are entirely responsible for manufacturing, we currently rely on a limited number of
CMOs and specific sites at those CMOs to manufacture and supply our product candidates. We expect to negotiate
contracts for commercial production on a product-by-product basis for products that we choose to commercialize on terms
that make us responsible for manufacturing.
There are a number of companies on a worldwide basis that operate manufacturing facilities in which our product
candidates can be manufactured under GMP regulations. We cannot be certain that we will be able to contract with any of
these companies on acceptable terms, if at all. New suppliers would also need to have sufficient rights under applicable
intellectual property laws to the method of manufacturing such ingredients. In addition, significant cancellation penalties
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and the long lead times required for initial orders or to make any changes to existing orders, including changing the scale of
production, limit our flexibility in connection with product development, clinical trials or commercial sales. For example,
we may be required to order products for the second part of a clinical trial or for a proposed follow-on clinical trial before
we have initial results from the trial, which could result in a loss if we terminate the trial or need to make changes to the
product.
We could also encounter difficulties, delays or inefficiencies in our supply chain, product manufacturing and
distribution networks, as well as sales or marketing, due to regulatory actions, shut-downs, work stoppages or strikes,
approval delays, withdrawals, recalls, penalties, supply disruptions, shortages or stock-outs at our facilities or third-party
facilities that we rely on, reputational harm, the impact to our facilities due to health pandemics or natural or man-made
disasters.
Lastly, CMOs, especially those located in non-US countries, may be subject to or affected by various US legislation,
executive orders, regulations, or investigations targeting certain development or economic activities involving those
countries. The CMO we use for the manufacturing of Rina-S is based in China, and there have been recent political and
economic tensions between China and the US. For example, the BIOSECURE Act enacted in December 2025 bans federal
procurement or funding associated with “biotechnology companies of concern” and restricts use of their equipment and
services in federal contracts, grants, and loans. The implementation of the act will be phased in over a period of years, and
could severely 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 US government. If our CMO for Rina-S is
affected by this legislation or any other action against Chinese companies and we are unable to secure alternative
manufacturing capacity on a timely basis, this could delay our commercial launch of Rina-S. It could also increase costs,
reduce the supply of available materials, delay procurement or clinical trials, hinder our ability to secure significant
government commitments for potential therapies, and adversely affect our financial condition and business prospects.
We and our manufacturing partners must comply with applicable laws and regulations, including cGMPs.
In order to commercialize new pharmaceutical and biologic products, manufacturers must comply with the laws and
regulations, including drug and biologic cGMPs, of the applicable governmental authorities. Compliance with cGMP
regulations requires significant expertise and capital investment, including the development of advanced manufacturing
techniques and process controls. Manufacturing facilities are also subject to pre-approval and ongoing periodic inspection
by applicable governmental agencies, including unannounced inspections, and must be licensed before they can be used in
commercial manufacturing of products employing our technology. The FDA, the European Medicines Agency (“EMA”) or
similar regulatory agencies at any time may also implement new standards or change their interpretation and enforcement
of existing standards for manufacturing, packaging or testing of products.
Manufacturers of pharmaceutical and biologic products encounter difficulties in production, including difficulties with
production yields, stability of the product candidate, quality control and assurance, shortages of qualified personnel,
compliance with relevant regulations, production costs and development of advanced manufacturing techniques and
process controls. If our manufacturer were to encounter any of these difficulties or otherwise fail to comply with its
obligations to us or under applicable regulations, our ability to provide trial materials in our preclinical trials and clinical
trials would be jeopardized. Any delay or interruption in the supply of preclinical trial or clinical trial materials could delay
the completion of our preclinical trials and clinical trials, increase the costs associated with maintaining our preclinical trial
and clinical trial programs and, depending upon the period of delay, require us to commence new trials at significant
additional expense or terminate the trials completely.
In addition, we lack direct control over our manufacturers’ compliance with these regulations and standards and
manufacturers of our products and product candidates may be unable to comply with these cGMP requirements and with
other regulatory requirements. The discovery of manufacturing, quality control or regulatory documentation problems or
failure to maintain compliance with cGMP or other requirements after approval of a product may result in restrictions on
the marketing of a product, revocation of the license, withdrawal of the product from the market, seizures, injunctions,
fines or criminal sanctions. If the safety of any product supplied is compromised due to the manufacturers’ failure to adhere
to applicable laws or for other reasons, we or our collaboration partners may not be able to continue clinical trials for our
product candidates, obtain regulatory approval for or successfully commercialize our products, and we or our collaboration
partners may be held liable for any injuries sustained as a result. Any of these factors could cause a delay in clinical trials,
regulatory submissions, approvals or commercialization of our products and product candidates or entail higher costs or
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impair our reputation. No assurance is given that third-party manufacturers will be able to comply adequately with the
applicable regulations.
Our employees and collaboration partners may engage in misconduct or other improper activities.
We are exposed to the risk of fraud or other misconduct by our employees and collaboration partners. Misconduct by
our collaboration partners, vendors or suppliers could include intentional failures to comply with legal requirements or the
requirements of the FDA, the EMA and other comparable regulatory authorities; failure to provide accurate information to
applicable government authorities; failure to comply with fraud and abuse and other healthcare laws and regulations in the
US, the EU and other jurisdictions; failure to comply with the Foreign Corrupt Practices Act (“FCPA”) and other
applicable anti-bribery laws; failure to report financial information or data accurately; or failure to disclose unauthorized
activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive
laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing, bribery and other abusive practices.
These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales
commission, customer incentive programs and other business arrangements. Our collaboration agreements include
provisions regarding regulatory compliance, but it is not always possible to identify and deter misconduct, and the
precautions we and our collaboration partners take to detect and prevent this activity may be ineffective 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 these laws or regulations. If any such actions are instituted against us, and we are
not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business,
including the imposition of significant fines or other sanctions.
Specifically, the FCPA prohibits companies and their intermediaries from making or offering improper payments to
non-US officials for the purpose of obtaining or retaining business, and requires companies listed on a US stock exchange
to maintain a system of adequate internal accounting controls and to make and keep books, records and accounts that
accurately and fairly reflect transactions and dispositions of assets. Because of the predominance of government-sponsored
health care systems around the world, many of our commercial relationships outside the US are with governmental entities,
and personnel of such entities may be considered non-US government officials for purposes of the FCPA. Violations of the
FCPA and other applicable anti-bribery laws are punishable by criminal fines and imprisonment, civil penalties,
disgorgement of profits, injunctions and debarment from government contracts as well as other remedial measures. We
have adopted a written code of business conduct, an anti-corruption, anti-bribery policy, and other policies and procedures
to assist us and our personnel in complying with the FCPA and other applicable anti-bribery laws, but there can be no
assurance that such policies will be effective in preventing or deterring violations of the FCPA, whether intentional or not.
Our personnel and others acting on our behalf could take actions that violate these requirements, which could adversely
affect our reputation, business, financial condition and results of operations.
Risks Related to Product Development
Biopharmaceutical product development involves a substantial degree of uncertainty.
Our product pipeline currently includes five proprietary products and product candidates in various stages of active
clinical development (early clinical development, late clinical development). There are also ongoing clinical trials for
daratumumab, amivantamab, teclistamab and talquetamab by J&J, ofatumumab by Novartis and teprotumumab by Amgen,
and additional product candidates being developed by our collaboration partners. Following the acquisition of Merus, we
expect to commence additional studies and continue current ongoing studies for petosemtamab. Many of our current
product candidates are in relatively early stages of development (preclinical proof of concept), and all of our product
candidates will require significant further development, financial resources and personnel to obtain regulatory approval and
develop them into commercially viable products, if at all.
Due to the uncertain, time-consuming and costly clinical development and regulatory approval process, we or our
collaboration partners may not successfully develop any of our product candidates, or we or our collaboration partners may
choose to discontinue the development or co-development of product candidates for a variety of reasons, including due to
safety, risk versus benefit profile, exclusivity, competitive landscape, commercialization potential, production limitations
or prioritization of our or our collaboration partners’ resources. In addition, our research programs may initially show
promise in identifying potential product candidates yet fail to yield product candidates suitable for clinical development or
commercialization. Likewise, we and our collaboration partners have to make decisions about which clinical stage and
preclinical product candidates to develop and advance. We may not have the resources to invest in all of our current
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product candidates, or clinical data and other development considerations may not support the advancement of one or more
product candidates. Decision-making about which product candidates to prioritize involves inherent uncertainty, and our
and our collaboration partners’ development program decision-making and resource prioritization decisions may not
improve our results of operations or future growth prospects.
Many of our proprietary and partnered product candidates are created with, and dependent upon, our proprietary
technologies, and some of them also incorporate technologies of our partners or other third parties. Any failures or setbacks
with respect to our proprietary technologies or Pfizer’s anti-body drug conjugate ("ADC") development programs,
including adverse effects resulting from the use of these technologies in human clinical trials and/or the imposition of
clinical holds on trials of any product candidates using our proprietary technologies, could have a detrimental impact on
our clinical pipeline.
Additionally, with the exception of acasunlimab, for which we discontinued clinical development in December 2025
and rinatabart sesutecan (“Rina-S”), we have not ourselves, or in collaboration, advanced any product candidates through
late-stage clinical development. If we are unable to continue to develop late-stage development capabilities, we will be
required to continue to contract with third parties via licensing and development agreements to complete the development
of our proprietary product candidates, which we may not be able to do on a timely basis, on terms favorable to us, or at all,
and the development of our proprietary product candidates could be delayed or terminated. Our failure to effectively
advance our development programs could have a material adverse effect on our business, financial condition, results of
operations and future growth prospects.
Furthermore, we may have to develop companion diagnostics to select the patient population that could benefit from
the relevant treatment, both during our clinical trials and in connection with the commercialization of our product
candidates, which are subject to regulation by the FDA, the EMA, and comparable foreign regulatory authorities as
companion diagnostic medical devices, and typically require separate regulatory approval prior to commercial use. Any
delay or failure by us or our collaboration partners to obtain regulatory approval of companion diagnostics could harm our
development strategy and/or delay or prevent approval of our product candidates, which may adversely affect our business,
financial condition and results of operations.
Our product candidates will need to undergo clinical trials that are time-consuming and expensive, the outcomes of
which are unpredictable, and for which there is a high risk of failure.
The FDA, EMA, and comparable regulatory authorities in other jurisdictions must approve new product candidates
before they can be marketed, promoted or sold in those territories. We or our collaboration partners must provide these
regulatory authorities with data from preclinical and clinical trials that demonstrate that our product candidates are safe and
effective for a specific indication before they can be approved for commercial distribution. We cannot be certain that our or
our collaboration partners’ preclinical or clinical trials for our product candidates will be successful or that any of our other
proprietary or partnered product candidates will receive approval from the FDA, the EMA or any other regulatory
authority. In addition, certain other third parties make decisions about products or product candidates based on results of
clinical trials, including determinations relating to pricing, access or reimbursement of approved products or validations or
endorsements of treatment options. Such third parties may require additional data or trials for their determinations.
Preclinical trials and clinical trials are long, expensive and unpredictable processes that can be subject to extensive
delays or failure.
We may be required to revise our development plans and extend dose exploration as a result of FDA’s Project
Optimus, which requires the implementation of strategies for dose finding and dose optimization that leverage preclinical
and clinical data in dose selection, including randomized evaluations of a range of doses in clinical trials. In support of this
initiative, the FDA may request sponsors of oncology product candidates to conduct dose optimization studies pre- or post-
approval.
It may take several years and require significant expenditures to complete the preclinical and clinical trials necessary to
commercialize a product candidate, and delays or failures are inherently unpredictable and can occur at any stage. Even if
we or our collaboration partners obtain positive results from preclinical or early clinical trials, we or they may not achieve
the same success in subsequent trials. In particular, the results of preclinical trials are based on animal, in vitro or other
laboratory testing and may not be predictive of the safety or efficacy of our product candidates in humans. Similarly,
topline or interim results of clinical trials do not necessarily predict final results. A number of companies in the
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pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical
trials even after obtaining promising results in earlier trials, and we cannot be certain that we or our collaboration partners
will not face similar setbacks. If topline or interim data that we or our collaboration partners report differ from final results,
or if others, including regulatory authorities, disagree with our assumptions, calculations, conclusions, or analyses or
interpret or weigh the data differently, or if subsequent trials are unsuccessful, we or our collaboration partners may be
unable to obtain marketing approval for product candidates on a timely basis or at all, which could impact our reputation,
business, financial condition, results of operations and future growth prospects.
Furthermore, the design of a clinical trial can determine whether its results will support approval of a product, and
flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced or completed. The
failure of clinical trials to demonstrate safety and efficacy for our or our collaboration partners' desired indications could
harm the development of the relevant product candidate as well as other product candidates employing the same
technology, which could have a significant impact on our product pipeline and future growth prospects. An unfavorable
outcome in one or more trials would be a major setback for our product candidates and for us and may require us or our
collaboration partners to delay, reduce the scope of or eliminate one or more product development programs, which could
have a material adverse effect on our business, financial position, results of operations and future growth prospects. Any
delays in product development may allow our competitors to bring products to market before we or our collaboration
partners do or shorten any periods during which we or our collaboration partners have the exclusive right to commercialize
our product candidates. In addition, advancements or changes in the industry standards or techniques may impact the value
and recognition of our and our collaboration partners’ clinical data. Failure to adopt new industry standards may result in
less comparable or useful trial results. Alternately, early adoption of emerging protocols or endpoints may result in data
that is not recognized by certain regulatory bodies or industry professionals, or if such protocols are later found to be
ineffective, may require us or our collaboration partners to change the design of our clinical trials.
In connection with clinical trials of our product candidates, we face a number of risks, including risks that:
•we or our collaboration partners may be unable to manufacture or obtain sufficient quantities of qualified
materials for clinical trials or may be required to modify manufacturing processes;
•patient recruitment may be slower than expected and we may have difficulty accessing potential clinical trial
sites;
•a product candidate may be ineffective, inferior to existing approved products for the same indications,
unacceptably toxic or have unacceptable side effects;
•patients may die or suffer other adverse effects for reasons that may or may not be related to the product
candidate being tested;
•a clinical trial may be delayed, suspended or terminated by the Institutional Review Board (“IRB”) or ethics
committee responsible for overseeing the clinical trial, by regulatory authorities or by us or our collaboration
partners due to failure to meet clinical protocols, safety issues or adverse effects, failure to demonstrate
product efficacy, changes in clinical protocols, may require additional dose finding and/or dose optimization,
or applicable regulatory requirements, lack of funding or other factors;
•investigators or other third parties could conduct clinical trials on our products or product candidates that
could lead to adverse events or results that could negatively impact the development, regulatory approval or
marketability of such products;
•extension trials on long-term tolerance could invalidate the use of our product;
•clinical trials may not demonstrate statistically sufficient levels of safety and efficacy to obtain the requisite
regulatory approvals;
•even if data is sufficient for regulatory approval, it may not be sufficient to secure pricing reimbursement or
to secure validation of our products by key industry players, which could delay or prevent the commercial
launch of a product; and
•our collaboration partners or CROs may be unable or unwilling to perform under their contracts.
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The FDA may not accept data from trials we or our collaboration partners conduct outside the US or may require
additional US-based trials as a condition of regulatory approval.
We and our collaboration partners have conducted, currently are conducting and intend in the future to conduct clinical
trials outside the US, including in the EU where we are headquartered. Although the FDA may accept data from clinical
trials conducted outside the US, acceptance of this data is subject to certain conditions imposed by the FDA, including with
respect to compliance with GCPs and applicability of the data to the US population and US medical practice in ways that
the FDA deems clinically meaningful. If the FDA does not accept the data from any clinical trials that we or our
collaboration partners conduct outside the US, it would likely result in the need for additional clinical trials, which would
be costly and time-consuming and delay or permanently halt our ability to develop and market these product candidates for
the proposed indications in the US. In other jurisdictions, for instance, in Japan, there is a similar risk regarding the
acceptability of clinical trial data conducted outside of that jurisdiction.
We or our collaboration partners may encounter difficulties enrolling patients in our clinical trials.
The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability
to enroll a sufficient number of patients who remain in the trial until its conclusion. We or our collaboration partners may
experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:
•the size and nature of the patient population;
•the patient eligibility criteria defined in the protocol;
•the size of the trial population required for analysis of the trial’s primary endpoints;
•the proximity of patients to trial sites;
•the design of the trial;
•our ability to recruit clinical trial investigators with the appropriate competencies and experience;
•competing clinical trials for similar therapies or other new therapeutics not involving our product candidates
and/or related technologies;
•clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate
being studied in relation to other available therapies, including any new drugs or treatments that may be
approved for the indications we are investigating;
•our ability to obtain and maintain patient consents; and
•the risk that patients enrolled in clinical trials will not complete a clinical trial.
In addition, our and our collaboration partners’ clinical trials will compete with other clinical trials for product
candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and
types of patients available for our and our collaboration partners’ clinical trials. We expect that we and our collaboration
partners will conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will
reduce the number of patients who are available for our and our collaboration partners’ clinical trials at such clinical trial
sites. Moreover, because our product candidates may represent a departure from more commonly used methods for cancer
treatment, potential patients and their doctors may be inclined to only use conventional therapies, such as chemotherapy
and radiation, rather than enroll patients in any future clinical trial.
Even if we and our collaboration partners are able to enroll a sufficient number of patients in our clinical trials, delays
in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which
could prevent completion of these trials and adversely affect our and our collaboration partners’ ability to advance the
development of our product candidates.
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Any approval granted for our products or product candidates in the US does not assure approval of such products in
Japan, the EU or other foreign jurisdictions.
In order to market and sell our drugs in Japan, the EU and other jurisdictions, we and our collaboration partners must
obtain separate marketing approvals, and comply with numerous and varying regulatory requirements. The approval
procedure varies among countries and can involve additional testing. The time required to obtain approval may differ
substantially from that required to obtain FDA approval. The marketing approval process outside the US generally includes
all of the risks associated with obtaining FDA approval. In addition, many countries outside the US require that the drug be
approved for reimbursement before the drug can be approved for sale in that country. We and our collaboration partners
may not obtain approvals from regulatory authorities outside the US on a timely basis, if at all. Approval by the FDA does
not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority
outside of the US does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
We may fail to obtain designations for expedited development or review or such designations may not lead to a faster
development or regulatory review. Acceptance into an expedited review program or receipt of accelerated approvals does
not assure ultimate full regulatory approval.
Fast Track Designation (“FTD”), Breakthrough Therapy Designation (“BTD”), and the accelerated approval programs
of the FDA and other regulatory authorities are intended to expedite the review and approval of drug candidates in certain
circumstances. These designations and programs do not, however, ensure that marketing approval will be granted in a
particular timeframe or at all. The FDA and other regulatory authorities have broad discretion regarding whether or not to
grant these designations or include product candidates within pilot programs, and, even if we or our collaboration partners
believe a particular product candidate is eligible for these designations or programs, we cannot assure that such authority
would agree. Even if we or our collaboration partners receive such designations or are eligible for inclusion in expedited
review pilot programs in the future, we may not experience a faster development, review or approval process compared to
conventional procedures. In addition, such designations or processing under such pilot programs may be withdrawn if the
FDA or the relevant regulatory body no longer believes such product candidate meets the criteria for the designation or
program. Furthermore, these designations and pilot programs do not change the scientific and medical standard for
approval or the quality of evidence necessary to support approval. As a result, applications for product candidates granted
expedited review or BTD or FTD designation may be ultimately denied based on trial data, trial design or other factors, and
even if our product candidates are accepted into such a program, this does not assure ultimate approval by the FDA or the
applicable regulatory body. Any accelerated approval received for our products, such as the approvals for EPKINLY, is
contingent on successful completion of diligently conducted post-marketing confirmatory trials, and accelerated approval
may be withdrawn if post-marketing trials do not verify the product’s benefit or demonstrate sufficient clinical benefit to
justify associated risks, other evidence demonstrates that the product is not safe or effective, or the FDA considers
promotional materials relating to the product to be false or misleading. The terms and conditions of expedited development
and review programs are subject to change as a result of regulatory developments, and any such changes may adversely
affect our ability to secure or maintain accelerated approvals or BTD, FTD or similar designations from the FDA or another
regulator. See “Item 4 –Information on the Company —Government Regulation” for more information about BTD, FTD
and accelerated approval programs for expedited review.
Risks Related to Our Products
We may be affected by reports of adverse events or safety concerns relating to our products or product candidates.
As with most biological drug products, use of our products and product candidates is associated with undesirable side
effects or adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to
prevalent. In particular, many of our and our collaboration partners’ clinical trials are conducted in patients with serious
life-threatening diseases for whom conventional treatments have been unsuccessful or for whom no conventional treatment
exists, and in some cases, our product candidates are used in combination with approved therapies that themselves have
significant adverse event profiles. During the course of treatment, these patients may suffer adverse medical events or die
for reasons that may or may not be related to our product candidates. Reports of adverse events or safety concerns could
have negative impacts on our or our collaboration partners’ clinical trials, regulatory processes, reputation and results,
whether or not actually shown to be related to our product candidates.
Reports of adverse events or safety concerns involving our products or product candidates have sometimes resulted
and can in the future result in regulatory authorities interrupting, delaying or halting clinical trials (or otherwise negatively
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impacting patient enrollment in or completion of clinical trials), limiting, denying, withdrawing approval of or recalling
such product for any or all indications, including the use of such product in its previously approved indications, or may
require additional clinical trials, updates to the prescribing information, including boxed warnings, contraindications, or
other labeling statements, implementation of a Risk Evaluation and Mitigation Strategy (“REMS”) or the issuance of field
alerts, warnings or other communications to physicians, pharmacies or patients. In certain cases, regulatory authorities may
order us or our collaboration partners to conduct additional trials or to cease further development or commercialization of
the product or product candidate entirely. Furthermore, actual or potential drug-related side effects can affect patient
recruitment or the ability of enrolled patients to complete a trial for our products or product candidates. Reports of adverse
events or safety concerns, or changes to regulatory approvals or labeling, may also have a significant impact on market
acceptance of our products by patients and physicians or may trigger potential product liability claims, fines, injunctions or
the imposition of civil or criminal penalties. Any of these events has the potential to prevent us or our collaboration
partners from developing, commercializing or maintaining market acceptance of the relevant product or product candidate
or to substantially increase commercialization costs, which in turn could significantly harm our business, financial
condition, results of operations and future growth prospects.
Adverse events may also impact the sales of our products. We may be required to further update the prescribing
information for our products, including boxed warnings, limitations of use, contraindications, warnings and precautions,
and adverse reactions, based on reports of adverse events or safety concerns, or implement a REMS, which could adversely
affect the acceptance of our products in the market, make competition easier or make it more difficult or expensive for us
or our collaboration partners to distribute our products. In addition, the reporting of adverse safety events involving our
products or product candidates, or public rumors about such events, could cause the price of ADSs to decline or experience
periods of volatility.
Several of our products and product candidates are used or proposed to be used in combination with other therapeutic
products, which exposes us to risks related to those products.
Part of the clinical development strategy for certain of our product candidates, including daratumumab, is to seek to
identify patients or patient subsets within a disease category whose treatment may benefit from our products in
combination with other therapeutic products. Approval of a product for the treatment of a disease indication in combination
with other therapeutic products exposes us and our collaboration partners to certain risks related to those other therapeutic
products, including the risks that such products will become less competitive or obsolete or will be found to have safety
concerns, which could potentially result in removal of such products from the market. Furthermore, seeking to heighten
immune or other therapeutic responses through combination treatments carries an inherent risk that the combination may
cause unexpected side effects or safety issues not observed in treatment with the individual products alone.
We may face product liability claims related to the use or misuse of our products or technologies.
Our business exposes us to potential product liability risks which are inherent in research and development, preclinical
and clinical testing, manufacturing, marketing and use of antibody products. Product liability claims may be expensive to
defend and may result in judgments against us which are potentially punitive. It is generally necessary for us to secure
certain levels of insurance as a condition for the conduct of clinical trials. Although we believe that our current coverage
limits are appropriate, we cannot be certain that the insurance policies will be sufficient to cover all claims that may be
made against us. Product liability insurance is expensive, difficult to obtain and may not be available in the future on
acceptable terms. Any claims against us, regardless of their merit, could cause our business to suffer. Even a successful
defense would require significant financial and management resources. Regardless of the merits or eventual outcome,
product liability claims may result in decreased demand for our products, injury to our reputation, withdrawal of clinical
trial participants and inability to continue clinical trials, initiation of investigations by regulators, costs to defend the related
litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients,
product recalls, withdrawals or labeling, marketing or promotional restrictions, exhaustion of any available insurance and
our capital resources, the inability to commercialize any product or product candidate, damage to our reputation, loss of
any potential future revenue and a decline in the market price of our ADSs.
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Risks Related to Our Business
We face intense competition and rapid technological change.
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies and intense
competition. Many third parties, including pharmaceutical companies, biotechnology companies, academic institutions and
other research organizations, compete with us in developing various approaches to antibody therapy and other competing
therapies. Many of our competitors have significantly greater financial resources and expertise in research and
development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approval and marketing
than we do, and earlier-stage companies may also prove to be significant competitors, especially through collaborative
arrangements with larger collaboration partners. In addition, many of these competitors are active in seeking patent
protection and licensing arrangements in anticipation of collecting royalties for use of technology that they have developed.
These third parties compete with us in recruiting and retaining qualified scientific and management personnel, as well as in
acquiring technologies complementary to our programs. In addition, many other pharmaceutical and biotechnology
companies are developing and/or marketing therapies for the same indications that our products and product candidates are
designed for and being developed to treat. In addition, our DuoBody and other technology partners may develop
compounds utilizing our technologies that may compete with product candidates that we are developing. See “Item 4B–
Business Overview—Competition” below for more information about our competitors.
In the US, the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), created an abbreviated approval
pathway for biological products that are demonstrated to be “highly similar” or “biosimilar” to or “interchangeable” with
an FDA-approved biological product, which may be used by our competitors to receive approval for, and commercialize,
product candidates that compete with our products with less effort and expense than would otherwise be required, and any
period of exclusivity for which our products qualify may be reduced to a shorter period than we expect due to regulatory
action or otherwise. See “Item 4B—Business Overview—Competition” for more information on this regulatory pathway.
It is possible that our competitors will succeed in developing products and technologies that are more effective than
our products and product candidates or that would render our technology obsolete or noncompetitive. It is also possible that
our competitors will succeed in developing biosimilar or interchangeable products for our products or our product
candidates. Competition is increasing from companies that are utilizing artificial intelligence and other computational
approaches for drug discovery, including the development of antibody therapies and other competing therapies. These
competitors may incorporate AI into their businesses more quickly or more successfully than us, which could impair our
ability to compete effectively and adversely affect our results of operations. We anticipate that we will continue to face
increasing competition in the future as new companies enter our market and scientific developments surrounding
biosimilars and other cancer therapies continue to accelerate. We cannot predict the extent to which these developments
will impact potential future sales of our products or our product candidates.
In addition, the pricing of our products depends, and the pricing of our product candidates, if and when approved for
marketing, will depend, in part, on the pricing strategies adopted by our competitors. If we or our collaboration partners are
forced to reduce the prices of our products, or if sales of our products fall due to competitive pricing, our revenue from
milestone payments, sales or royalties related to such products will be negatively affected.
Any products we or our collaboration partners are able to commercialize in the US and the EU may be subject to
competition from lower-priced imports of those same products, as well as lower-priced imports of competing products
from Eastern Europe, Canada, Mexico and other countries with government price controls or other market dynamics that,
in each case, reduce prices of products leading to reduced revenues and lower sales margins. The ability of patients to
obtain these lower-priced imports has grown significantly. Some of these foreign imports are illegal under current US and
European law. However, the volume of imports is now significant, due in part to the limited enforcement resources and the
pressure in the current political environment to permit the imports as a mechanism for expanding access to lower-priced
medicines. Parallel importation or importation of foreign products could adversely affect our future profitability. This
impact potentially could become even greater if there is a further change in relevant protective legislation or if state or local
governments take further steps to import products from abroad.
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Our business applications and IT infrastructure, or those of our collaboration partners, contractors or consultants, may
fail or suffer cybersecurity breaches, and the use of novel technologies may subject us to additional risks.
Our business applications and IT infrastructure, including those hosted by third parties, and those of our collaboration
partners, contractors or consultants, may be vulnerable to cybersecurity risks, such as ransomware, malware, identify theft,
system or application failure,, and natural disasters, terrorism, war and telecommunication and electrical failures, which can
lead to damage, loss or leakage of business data or unavailability of computer systems. Our vulnerability to such events
may increase while employees work remotely which results in additional cybersecurity threat profiles and an increase in
the amount of traffic on secured remote corporate networks and preventing or detecting unauthorized access to internal
networks may be more challenging. These and other factors, including the increased use of artificial intelligence by threat
actors, can be exploited to facilitate phishing, malware, ransomware or other attacks on our systems. If such an event were
to occur, it could result in a critical or material disruption of our development programs and our business operations. In
addition, any loss or disclosure of trade secrets, clinical data, personal data, or other proprietary information as a result of
such disruption or breach could subject us to litigation, loss of intellectual property rights, or regulatory review and
sanctions and may impact our reputation and our collaboration partners’ ability to further develop and commercialize our
products and product candidates, any of which could have a material adverse effect on our business, financial condition,
results of operations and the market price of our ADSs.
Artificial intelligence-based software is increasingly being used in the biopharmaceutical and global healthcare
industries. We have expanded our scientific focus to use data science and artificial intelligence to aid in the discovery of
new targets and biomarkers and bolster our in-depth precision medicine and translational laboratory capabilities. As with
many developing technologies, artificial intelligence-based software presents risks and attack surfaces. If the analyses that
artificial intelligence-based applications assist in producing are deficient or inaccurate, we could be subjected to
competitive harm, potential legal liability and brand or reputational harm. Furthermore, use of artificial intelligence-based
software may lead to the release of confidential information which may impact our ability to realize the benefits of our
intellectual property. The integration of artificial technology into our and our vendors’ systems (potentially without the
vendor disclosing such use to us) subjects us to the risk that the providers of artificial technology may not meet existing or
rapidly evolving regulatory or industry standards with respect to privacy and data protection. Further, regulatory changes or
reinterpretations could introduce new compliance risks, including potential government enforcement actions or civil
lawsuits.
Climate change or legal, regulatory or market measures to address climate change may negatively affect
our financial condition and business operations.
Climate change may negatively affect our business, results, and value chain. Our primary exposure relates to physical
and transition risks such as natural or man-made disasters, extreme weather conditions such as hurricanes, tornadoes,
earthquakes, wildfires or flooding, or regulatory changes that could disrupt production or increase costs. Physical risks may
cause damage, delays, or reduced material availability across our limited number of third-party manufacturers for our
product supply, while evolving climate regulations and carbon-related requirements may lead to higher compliance and
energy costs across the value chain. These combined factors could negatively affect our operations, product development,
and long-term resilience.
Environmental, social and governance (“ESG”) matters may impact Genmab’s business, operations, and reputation.
Some investors, customers, and other stakeholders are increasingly focused on issues such as climate change, health
and safety, human rights and responsible supply chain practices. At the same time, sentiment that is critical of certain ESG
practices has gained momentum across the US, with several proposed or enacted “anti-ESG” policies, legislation, or
initiatives, and the US federal administration has issued an executive order opposing diversity, equity and inclusion
initiatives in the private sector. Evolving requirements—such as the EU Corporate Sustainability Reporting Directive and
emerging climate disclosure rules—may lead to higher compliance, reporting, and assurance costs. As Genmab’s
manufacturing is limited to a number of third-party manufacturers for our product supply, we also depend on third parties
to manage ESG risks in their own operations. Our ESG goals and commitments require investment and carry uncertainties.
Failure, or perceived failure, to meet these goals and commitments or to align with evolving, and sometimes conflicting,
laws, regulations, policies and administrative, investor and other stakeholder views could result in reputational harm,
increased scrutiny from investors or proxy advisors, reduced talent attraction and retention, and other adverse effects on our
business and results of operations.
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Our business depends on our ability to recruit and retain talented and highly skilled employees.
Our success depends on the ability to attract, develop, and retain highly skilled and diverse talent across scientific,
technical, and leadership roles. Competition for qualified professionals in the biotechnology industry is intense, as we
compete with global pharmaceutical and biotech companies, academic institutions, and other organizations for experienced
personnel. Our ability to achieve strategic objectives relies on maintaining a strong, purpose-driven culture, competitive
compensation, and opportunities for professional growth. Failure to attract or retain key talent could negatively affect
Genmab’s ability to advance its pipeline, meet operational goals, and deliver long-term value.
Risks Related to Our Intellectual Property
Our ability to compete may decline if we or our collaboration partners are unable to or do not adequately protect
intellectual property rights or if our intellectual property rights are inadequate.
Our commercial success and viability depend in part on our and our collaboration partners’ ability to obtain and
maintain adequate intellectual property protection in the US, Europe and other countries with respect to our existing
products, product candidates and processes and related technologies owned by us and to successfully defend these rights
against third-party challenges, successfully enforce these rights to prevent third-party infringement, as well as our ability to
maintain adequate intellectual property protection for any future technologies and products. If we or our collaboration
partners do not adequately protect our intellectual property, competitors may be able to use our technologies or products
and erode or negate any competitive advantage we may have, which could materially harm our business, negatively affect
our position in the marketplace, limit our ability to commercialize our products and product candidates and significantly
reduce our revenues and potential profits.
While we rely on a combination of patents, trademarks and trade secret protection, as well as nondisclosure,
confidentiality and other contractual agreements to protect the intellectual property related to our brands, products, product
candidates and proprietary technologies, our strategy and future prospects are based, in particular, on our patent portfolio.
The uncertainties with respect to the legal system in the US, Europe and other countries, including uncertainties regarding
the enforcement of laws, and sudden or unexpected changes in laws and regulations with little advance notice, or policies
and practices that weaken the intellectual property framework (such as laws or regulations that promote or provide broad
discretion to issue a compulsory license) could adversely affect us and limit the legal protections available to us. We and
our collaboration partners or licensees will best be able to protect our technologies, products and product candidates and
their uses from unauthorized use by third parties to the extent that valid and enforceable patents, effectively protected trade
secrets, or other regulatory exclusivities, cover them. However, the process of obtaining patent protection is expensive and
time-consuming, and we may not be able to prosecute all necessary or desirable patent applications at a reasonable cost or
in a timely manner.
The patent position and other intellectual property rights of biopharmaceutical companies involve complex legal,
administrative and factual questions, and the issuance, scope, validity and enforceability of patents cannot be predicted
with certainty. Also, intellectual property rights have limitations and do not necessarily address all potential threats to our
competitive advantage. Our and our collaboration partners’ ability to obtain patent protection for our or their technologies,
products and product candidates is uncertain, and the degree of future protection afforded by such intellectual property
rights is uncertain due to a number of factors, including, but not limited to:
•we or our collaboration partners may not have been the first to make or file patent applications for the
inventions covered by pending patent applications or issued patents;
•others may independently develop identical, similar or alternative technologies, products or compositions and
uses thereof;
•any or all of our or our collaboration partners’ pending, or any future patent applications may not result in
issued patents;
•any patents issued to us or our collaboration partners may not provide a basis for commercially viable
products, or may not provide any competitive advantages in countries of significant business opportunity;
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•third parties may initiate interference, re-examination, post-grant review, inter partes review, or derivation
actions in the US Patent and Trademark Office (“USPTO”), or oppositions in the European Patent Office
(“EPO”), or observations or protests, or any similar actions in other patent administrative or court
proceedings worldwide that challenge the validity, enforceability or scope of such patents, which may result
in our patent claims being narrowed or invalidated which could limit our ability to prevent competitors from
developing and marketing similar products;
•our or our collaboration partners’ technologies, compositions and methods may not be patentable;
•others may design around our or our collaboration partners’ patent claims to produce competitive products or
uses which fall outside of the scope of our patents;
•third parties may have blocking patents that could prevent us from marketing our products or practicing our
own patented technology;
•patent terms may be inadequate to protect our competitive position on our technologies, products and product
candidates for an adequate amount of time;
•the Supreme Court of the US, other US federal courts, Congress, the USPTO or similar foreign authorities
may change the standards of patentability and any such changes could narrow or invalidate, or change the
scope of, or change the patent lifetime of, our or our collaboration partners’ patents; and
•the USPTO and various foreign governmental patent agencies require compliance with a number of
procedural, documentary, fee payment, and other similar provisions during the patent application process. In
addition, periodic maintenance fees on issued patents often must be paid to the USPTO and foreign patent
agencies over the lifetime of the patent. While an unintentional lapse can in many cases be cured by payment
of a late fee or by other means in accordance with the applicable rules, there are situations in which
noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or
complete loss of patent rights in the relevant jurisdiction.
Patent applications may be denied or issued patents covering our products and product candidates could be found
invalid or unenforceable.
Even if patents do successfully issue and even if such patents cover our technologies, products, product candidates,
compositions and methods of use, third parties may initiate interference, re-examination, post-grant review, inter partes
review, or derivation actions in the USPTO, third-party oppositions at the EPO or observations or protests, or similar
actions challenging the validity, enforceability or scope of such patents in other patent administrative proceedings
worldwide, which may result in our or our collaboration partners’ patent claims being narrowed or invalidated. Such
proceedings could result in revocation or amendment of such patents in such a way that they no longer cover our
technologies, product candidates or competitive products. Further, if we or our collaboration partners initiate legal
proceedings against a third-party to enforce a patent covering our product, product candidate or technology, the defendant
could counterclaim that the patent covering our product, product candidate or technology is invalid or unenforceable. In
patent litigation in the US, certain European and other countries worldwide, it is commonplace for defendants to make
counterclaims alleging invalidity and unenforceability in the same proceeding, or to commence parallel defensive
proceedings such as patent nullity actions to challenge validity and enforceability of asserted patent claims. Such
proceedings could result in revocation or amendment of such patents in such a way that they no longer cover our
technologies, product candidates or competitive products.
We currently rely on proprietary technology licensed from third parties and may rely on other third-party licensors in
the future. If we lose our existing licenses or are unable to acquire or license additional proprietary rights from these
licensors or other third parties, we may not be able to continue developing and commercializing our products.
We currently in-license certain technology and intellectual property from third parties to be able to use such
technology and intellectual property in our products and product candidates and to aid in our research activities. In the
future we may in-license technology and intellectual property from additional licensors.
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We rely on certain of these licensors to file and prosecute patent applications and maintain patents and otherwise
protect the technology and intellectual property we license from them. We have limited control over these activities or any
other technology and intellectual property that may be related to our in-licensed intellectual property. For example, we
cannot be certain that such activities by these licensors have been or will be conducted in compliance with applicable laws
and regulations or will result in valid and enforceable patents and other intellectual property rights. We have limited control
over the manner in which our licensors initiate an infringement proceeding against a third-party infringer of the intellectual
property rights or defend certain of the technology and intellectual property that is licensed to us.
The growth of our business may depend in part on our ability to acquire or in-license additional proprietary rights. We
may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or
important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable
terms, if at all, which would harm our business. We may need to proceed without making use of the technologies,
compositions or methods covered by such third-party intellectual property rights and may need to attempt to develop
alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and
development delays, even if we were able to develop such alternatives, which may not be feasible at a reasonable cost or at
all. The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that
may be more established, or have greater resources or greater clinical or commercialization capabilities than we do, may
also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or
attractive in order to commercialize our product candidates, products and related proprietary technologies. Furthermore,
companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Even if we are able to
obtain a license under third-party intellectual property rights, any such license may be non-exclusive, which may allow our
competitors to access the same technologies licensed to us. If we are unable to successfully obtain rights to additional
technologies or products, our business, financial condition, results of operations and prospects for growth could suffer.
Our existing in-licenses impose various diligence, milestone payment, royalty and other obligations on us. If we fail to
comply with these obligations or otherwise materially breach a license agreement, our licensors or collaboration partners
may have the right to terminate the license. Under the terms of some of the relevant agreements, our collaboration partners
also have the right to terminate the agreements at their discretion. In the event of termination of any of these agreements,
we may not be able to develop or market the products covered by such licensed intellectual property. In addition, any
claims asserted against us by our licensors may be costly and time-consuming, divert the attention of key personnel from
business operations or otherwise have a material adverse effect on our business.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property.
Competitors may infringe our patents, trademarks or other intellectual property. To counter infringement or
unauthorized use, we may be required to file infringement claims on a country-by-country basis, which can be expensive
and time consuming and divert the time and attention of our management and scientific personnel. Any claims we assert
against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their
patents, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent
infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or
in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that,
even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not
have the right to stop the other party from continuing its activities on the grounds that our patent claims do not cover these
activities. An adverse outcome in a litigation or proceeding involving one or more of our patents could limit our ability to
assert those patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties
from making and selling similar or competitive products, which could materially harm our business and negatively affect
sales of our products. Similarly, if we assert trademark or trade name infringement claims, a court may determine that the
trademarks or trade names we have asserted are invalid or unenforceable, or that the party against whom we have asserted
infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such
trademarks or trade names, which we may need in order to build name recognition with potential collaboration partners or
customers in our markets of interest, thus this could materially harm our business and negatively affect our position in the
marketplace.
Further, even if we prevail against an infringer in a US district court or foreign trial-level court, there is always the risk
that the infringer will file an appeal and the initial court judgment will be overturned at the appeals court and/or that an
adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents. An adverse
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result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted in a
manner insufficient to achieve our business objectives.
Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity
and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the
substantial amount of discovery required in connection with intellectual property litigation in certain territories, there is a
risk that some of our confidential information could be compromised by disclosure during litigation. There could also be
public announcements of the results of hearings, motions or other interim proceedings or developments, which securities
analysts or investors could perceive to be negative. Moreover, there can be no assurance that we will have sufficient
financial or other resources to file and pursue such infringement claims, which typically last for years before they are
concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the
attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings.
Claims that our products or product candidates or their uses infringe the intellectual property rights of third parties
could result in the need for third-party licenses with royalty payments or costly litigation with unfavorable outcomes.
Even if we or our collaboration partners have or obtain patents covering our technologies, products, product
candidates, compositions or uses, we or our collaboration partners may still be barred from making, using, importing or
selling or otherwise exploiting our products, product candidates or technologies because of the patent rights of others. Our
competitors have filed, and in the future may file, patent applications covering technology, compositions or products and
uses that are similar or identical to ours. There are many issued US, European and other worldwide patents relating to
therapeutic drugs, and some of these may relate to compounds we or our collaboration partners intend to commercialize.
Numerous worldwide patents and pending patent applications owned by others exist in the cancer field and may cover
products or product candidates which we or our collaboration partners are developing. It is difficult for industry
participants, including us, to identify all third-party patent rights relevant to our products, product candidates and
technologies. We cannot guarantee that our technologies, products, product candidates, compositions and their uses do not
or will not infringe third-party patents or other intellectual property rights. Because patent applications usually take
18 months to publish and many years to issue, there may be currently pending applications with patent claims unknown to
us or which will change over time and may later result in issued patents that purportedly cover our technologies, products,
product candidates or compositions and uses. These patent applications may have been filed earlier than or have priority
over patent applications filed by us or our collaboration partners. We may be required to develop or obtain alternative
technologies, review product design or, in the case of claims concerning registered trademarks, rename our products or
product candidates.
Claims that our or our collaboration partners’ technologies, products, product candidates, compositions or their uses
infringe or interfere with the patent rights of third parties, or that we, our employees, our consultants or our collaboration
partners have misappropriated third-party trade secrets, are being brought from time to time and can result in costly
litigation and could require substantial time and money to resolve, even if litigation is avoided.When we, our employees,
our consultants or our collaboration partners face infringement claims or challenges by third parties, an adverse outcome
could subject us or our collaboration partners to significant liabilities to such third parties. Litigation or threatened litigation
could result in significant demands on the time and attention of our management team. A negative outcome could expose
us or our collaboration partners to payment of costs, damages and other financial remedies, including in some jurisdictions,
increased damages, such as treble damages and attorneys’ fees, if we were found to have willfully infringed a patent, and
equitable remedies such as restraining orders or injunctions. Litigation with third parties concerning alleged infringement
of their intellectual property rights could require us and our collaboration partners to bear substantial costs and impose
burdens on our and their management and personnel, even if we or our collaboration partners were to ultimately succeed in
such proceedings. Costs of patent litigation and awards of damages in patent infringement cases can be significant, and
equitable remedies such as temporary restraining orders and injunctions can negatively impact or prevent product
development and commercialization. A negative outcome could also lead us or our collaboration partners to delay, curtail
or cease the development and commercialization of some or all of our products and product candidates, or could cause us
or our collaboration partners to seek legal or administrative actions against third parties. We or our collaboration partners
may need to obtain licenses from third parties and such licenses may not be available on commercially reasonable terms, or
at all. Even if we are able to obtain licenses from a third-party to resolve a dispute, such settlement arrangements could
involve substantial costs including one-time and/or ongoing royalty payments.
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We may be unable to protect the confidentiality of our trade secrets and know-how.
In addition to seeking patent protection for our products and product candidates, we also rely on trade secrets,
including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We
seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who
have access to them, such as our employees, collaboration partners, consultants, advisors, vendors, university and/or
institutional researchers and other third parties. We also have entered or seek to enter into confidentiality and invention or
patent assignment agreements with our employees, advisors and consultants. Despite these efforts, any of these parties may
breach the agreements and disclose our proprietary information, including our trade secrets, and once disclosed we may
lose trade secret protection. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we
do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not
be able to obtain adequate remedies for such breaches. Our trade secrets may also be obtained by third parties by other
means, such as breaches of our physical or computer security systems. Enforcing a claim that a party illegally disclosed or
misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable and may be
inadequate. In addition, some courts inside and outside the US are less willing or unwilling to protect trade secrets.
Moreover, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would
have no right to prevent them, or those to whom they communicate it, from using that technology or information to
compete with us. If any of our trade secrets were to be disclosed to, or independently developed by, a competitor, our
competitive position would be harmed.
We will not seek to protect our intellectual property rights or technologies 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.
Obtaining and maintaining a patent portfolio entails significant expense and resources. Filing, prosecuting and
defending patents on our technologies, products and product candidates in all countries and jurisdictions throughout the
world would be prohibitively expensive and, therefore, we typically elect to seek protections in certain jurisdictions only.
We may choose not to pursue or maintain protection for particular inventions, products or product candidates. 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 forego patent protection or allow a patent application or patent to lapse
purposefully or inadvertently, our competitive position could suffer, and our contractual royalty rates on sales of wholly- or
partially-partnered products in the relevant jurisdictions may be reduced. Competitors may use our technologies in
jurisdictions where we do not pursue and obtain patent protection to develop their own products in a manner that exploits
our technologies and, further, may export otherwise infringing products to territories where we have patent protection, but
enforcement is not as strong as that in the US or in Europe, and thus such protection may not be sufficient to prevent or
stop infringing activities.
The requirements for patentability may differ from country to country, particularly in developing countries, and the
breadth of patent claims allowed can be inconsistent. In addition, the legal systems of some countries, particularly
developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those
relating to biopharmaceuticals or biotechnologies. This could make it difficult for us to stop the infringement of our patents
or the misappropriation of our other intellectual property rights. Also, many foreign countries have compulsory licensing
laws under which a patent owner must grant licenses to third parties if the patents are not being exploited within a certain
time period. 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 or region-by-region basis, which is an expensive and time-consuming process
with uncertain outcomes. If we fail to timely file a patent application in a specific country or major market, we may be
precluded from doing so at a later date.
In addition, changes in the law and legal decisions by courts in the US, Europe and foreign countries may affect our
ability to obtain or maintain adequate protection for our technologies, products, product candidates or compositions or uses
thereof and the enforcement of intellectual property, and may apply retroactively to affect the term and/or scope of our
patents. Additionally, the legal systems of certain countries, particularly China and certain other countries, may not protect
patents, trade secrets and other intellectual property to the same extent or in the same manner as the laws of the US,
particularly those relating to medical devices and biopharmaceutical and biotechnology products, which could make it
difficult for us to prevent or stop the infringement of our patents or other violations of our proprietary rights generally.
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Third parties may in the future make claims challenging the inventorship or ownership of our intellectual property. We
have written agreements with our collaboration partners that provide for the ownership of intellectual property arising from
our collaborations. In some instances, there may not be adequate written provisions to address clearly the resolution of
intellectual property rights that may arise from collaboration. Disputes may arise with respect to ownership of the
intellectual property developed pursuant to such collaborations. 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 we have developed or will develop and 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 in that intellectual property.
Either outcome could have an adverse impact on our business, financial condition, results of operations and future growth
prospects.
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.
Our registered or unregistered trademarks and 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 among potential collaboration partners or customers in our markets
of interest. If we do not own or control trademarks associated with our products, product candidates or technologies, we
may not be in control of defending against any claims brought against those trademarks. At times, competitors may adopt
trademarks and trade names similar to ours, thereby impeding our ability to build brand identity and possibly leading to
market confusion. In addition, there could be potential trademark infringement claims brought by owners of other
registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks. Over the long
term, if we are unable to establish name recognition based on our trademarks, then we may not be able to compete
effectively, and our business may be adversely affected.
In addition, any proprietary name we propose to use with any of our product candidates in the US or other jurisdictions
must be approved by the FDA, the EMA or other governmental authorities, regardless of whether we have registered, or
applied to register, the proposed proprietary name as a trademark. The FDA typically conducts a review of proposed
product names, including an evaluation of potential confusion with other product names. If the FDA objects to any of our
proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify
a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of
third parties and be acceptable to the FDA.
Risks Related to Government Regulation
Government restrictions on pricing and reimbursement, as well as other healthcare payer cost-containment initiatives,
may negatively impact our ability to generate revenue.
Sales of certain of our products and our product candidates, if and when approved for marketing, have and will
depend, in part, on the extent to which our products will be covered by third-party payers, such as US government health
care programs like Medicare and Medicaid, commercial insurance and managed healthcare organizations. These third-party
payers play an important role in determining the extent to which new drugs, biologics and medical devices will be covered.
The Medicare and Medicaid programs increasingly are used as models for how private payers and other governmental
payers develop their coverage and reimbursement policies for drugs, biologics and medical devices. It is difficult to predict
at this time what third-party payers will decide with respect to coverage and reimbursement for our product candidates.
Further, the adoption and implementation of any future governmental cost containment or other health reform initiative
may result in additional downward pressure on the price that we may receive for any approved product. Outside the US,
international operations are generally subject to extensive governmental price controls and other market regulations.
Therefore, the reimbursement for our products may be reduced compared with the US and may be insufficient to generate
commercially reasonable revenue and profits. Adoption of price controls, cost containment measures, and adoption of more
restrictive policies in jurisdictions with existing controls and measures could limit our net revenue and results.
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Further, from time to time, typically on an annual basis, payment rates are updated and revised by third-party payers.
Such updates could impact the demand for our products, to the extent that patients who are prescribed our products, if
approved, are not separately reimbursed for the cost of the product.
In addition, in certain jurisdictions, marketing approval for a product, or the ability to launch an approved product, is
subject to determination of pricing and reimbursement levels. In such jurisdictions, even if we or our collaboration partners
are able to obtain marketing approval for our products, commercialization of our products may be significantly delayed or
prevented altogether if we are unable to secure reimbursement for our products, at competitive levels or at all.
Moreover, increasing efforts by governmental and third-party payers in the US and abroad to cap or reduce healthcare
costs may cause such organizations to limit both coverage and the level of reimbursement for new products approved and,
as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing
pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the
increasing influence of health maintenance organizations, and additional legislative changes. The downward pressure on
healthcare costs in general, particularly prescription drugs, medical devices and surgical procedures and other treatments,
has become very intense. As a result, increasingly high barriers are being erected to the successful commercialization of
new products.
In addition, any products we or our collaboration partners are able to commercialize may be subject to competition
from lower-priced imports of those same products, leading to reduced revenues and lower sales margins, as well as lower-
priced imports of competing products from countries with government price controls or other market dynamics that, in
each case, reduce prices of products.
Even if approved, our products will be subject to extensive post-approval regulation, which may result in significant
additional expense. 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.
Once a product is approved, the manufacturing processes, labeling, packaging, distribution, adverse event reporting,
storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory
requirements. For US approvals, the holder of an approved Biologics License Application (“BLA”) is subject to periodic
and other FDA monitoring and reporting obligations, including obligations to monitor and report adverse events and
instances of the failure of a product to meet the specifications in the BLA. In addition, the FDA strictly regulates the
promotional claims that may be made about pharmaceutical products. In particular, a product may not be promoted for uses
that are not approved by the FDA as reflected in the product’s approved labeling. Application holders must also submit
advertising and other promotional material to the FDA and report on ongoing clinical trials.
Advertising and promotional materials must comply with FDA rules in addition to other potentially applicable federal
and state laws. In addition, we or our collaboration partners may be subject to significant liability if physicians prescribe
any of our products to patients in a manner that is inconsistent with the approved label and if we are found to have
promoted off-label uses of such products. The FDA has also requested that companies enter into consent decrees or
permanent injunctions under which specified promotional conduct is changed or curtailed. Manufacturing facilities remain
subject to FDA inspection and must continue to adhere to the FDA’s cGMP requirements. Application holders must obtain
FDA approval for product and manufacturing changes, depending on the nature of the change. In addition, any regulatory
approvals that we or our collaboration partners 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 IV clinical trials, and surveillance to monitor the safety and
efficacy of the product candidate.
Sales, marketing, patient support, and scientific/educational grant programs in the US must comply with the US
Medicare-Medicaid Anti-Fraud and Abuse Act, as amended, the False Claims Act, also as amended, the federal Anti-
Kickback Statute, the Federal Food, Drug and Cosmetic Act, and similar state laws. Pricing and rebate programs must
comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the
Veteran’s Health Care Act, as amended. If products are made available to authorized users of the Federal Supply Schedule
of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially
subject to federal and state consumer protection and unfair competition laws.
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Within the EU, once a marketing authorization is obtained, numerous post-approval requirements also apply. The
requirements are promulgated by both EU regulations (such as reporting of adverse events, etc.) as well as national
applicable regulations (related to, for example, prices and promotional material). In addition, as part of its marketing
authorization process, the EMA may grant marketing authorizations on the basis of less complete data than is normally
required, when, for certain categories of medicinal products, doing so may meet unmet medical needs of patients and serve
the interest of public health. In such cases, it is possible for the Committee for Medicinal Products for Human Use
(“CHMP”), to recommend the granting of a marketing authorization, subject to certain specific obligations to be reviewed
annually, which is referred to as a conditional marketing authorization. This may apply to medicinal products for human
use that fall under the jurisdiction of the EMA, including those that target the treatment, prevention, or medical diagnosis of
seriously debilitating diseases or life-threatening diseases and those designated as orphan medicinal products. The granting
of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is not yet
fully complete. Incomplete non-clinical or quality data may only be accepted if duly justified and only in the case of a
product intended to be used in emergency situations in response to public-health threats. Conditional marketing
authorizations are valid for one year, on a renewable basis. The holder will be required to complete ongoing trials or to
conduct new trials with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may
be imposed in relation to the collection of pharmacovigilance data. Although we may seek a conditional marketing
authorization for one or more of our product candidates by the EMA, the EMA or CHMP may ultimately not agree that the
requirements for such conditional marketing authorization have been satisfied.
Other jurisdictions also impose certain post-approval requirements or may grant conditional marketing approvals.
Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines
or other penalties, injunctions, notices or warning letters, recall or seizure of products, total or partial suspension of
production or changes to manufacturing processes, denial or withdrawal of pre-marketing product approvals, import
controls, or refusal to allow us to enter into supply contracts, including government contracts, each of which could have a
significant impact on our business, financial condition, results of operations, future growth prospects and reputation. In
addition, even if we and our collaboration partners comply with FDA, EMA and other applicable requirements, new
information regarding the safety or effectiveness of a product could lead the FDA, the EMA or other regulatory authorities
to modify or withdraw a product approval. Any government investigation of alleged violations of law could also require us
or our collaboration partners to expend significant time and resources in response and could generate negative publicity.
Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our and our
collaboration partners’ ability to commercialize and generate revenue from our products. If regulatory sanctions are applied
or if regulatory approval is withdrawn, the value of our company and our operating results could be adversely affected.
A rapidly evolving legal, regulatory and policy landscape may have an adverse impact on our business.
Existing regulatory policies may change and additional government regulations may be enacted that could prevent,
limit or delay regulatory approval of our products and product candidates. We cannot predict the likelihood, nature or
extent of government regulation that may arise from future legislation or administrative action, either in the US, the EU or
in other countries. If we or our collaboration partners are slow or unable to adapt to changes in existing requirements or the
adoption of new requirements or policies, or if we and our collaboration partners are not able to maintain regulatory
compliance, we or they may lose any marketing approval that we or they may have obtained, which could adversely impact
our business and financial results.
The Inflation Reduction Act of 2022 (“IRA”) was signed into law on August 16, 2022. The IRA, among other things,
(i) allows the US Department of Health and Human Services (“HHS”) to negotiate prices for certain single-source drugs
and biologics covered under Medicare Part B and Part D, and subjects drug manufacturers to civil monetary penalties and a
potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the
negotiated “maximum fair price” under the law; and (ii) establishes rebates under Medicare to penalize drug price increases
that outpace inflation. Negotiations were conducted with ten high-cost drugs, none of which was DARZALEX, paid for by
Medicare Part D, and the negotiated prices will take effect in 2026. The effect of the IRA on the biopharmaceutical
industry is uncertain, and the IRA could have a material effect on our business and results of operations in the future.
In the US there is continued focus by the US federal and state governments on regulating or otherwise decreasing drug
prices. This includes efforts to establish international reference pricing, including Most-Favored-Nation (“MFN”) drug
pricing. On May 12, 2025, the US President issued an executive order “Delivering Most- Favored-Nation Prescription
Drug Pricing to American Patients,” directing executive agencies to take steps to facilitate MFN pricing for prescription
drugs in the US. The Secretary of HHS subsequently announced on May 20, 2025, that it communicated to manufacturers
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MFN pricing targets which apply to brand drugs and biologics without generic or biosimilar competition, using the lowest
prices observed in a set of economic peer countries (commonly described as OECD countries meeting a GDP-per-capita
threshold). Manufacturers are expected to make “significant progress” toward meeting these targets. If they fail to do so,
then other actions are to be pursued, including proposing rules to implement MFN pricing, working with Congress to allow
for expanded drug importation, exploring FDA drug approval reforms, increased antitrust enforcement and review of drug
export practices. The order also calls on the Secretary of Commerce and the US Trade Representative to address foreign
pricing practices that may harm US interests, including suppressing drug prices abroad and shifting the global research
burden to American consumers. Additionally, the order directs HHS to support direct-to-consumer sales at MFN prices,
seeking to bypass intermediaries in the current US drug supply chain. On July 31, 2025, the White House sent letters to 17
pharmaceutical manufacturers, which included Genmab collaboration partners AbbVie, J&J, Novartis and Pfizer, outlining
specific steps, including offering MFN prices to all Medicaid patients, committing not to offer better prices to other
developed nations for new drugs than prices offered in the US, and participating in direct-to-consumer or direct-to-business
models at MFN prices. The US administration recently announced voluntary MFN agreements with Pfizer and
AstraZeneca, signaling potential expectations for other manufacturers to follow. These actions demonstrate the growing
interest in aggressive policies to lower drug prices, which could adversely affect the prices of products that we or our
collaboration partners sell, and thereby our revenues and profits.
Our and our partners’ activities in certain non-US countries may also be subject to or affected by various US
legislation, executive orders, regulations, or investigations targeting certain development or economic activities involving
those countries. This includes, but is not limited to, the proposed BIOSECURE Act, which could increase costs, reduce the
supply of available materials, delay procurement or clinical trials, hinder our ability to secure significant government
commitments for potential therapies, and adversely affect our financial condition and business prospects.
In June 2024, the US Supreme Court overruled the Chevron doctrine, which gave deference to regulatory agencies’
statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.
This landmark Supreme Court decision may invite more companies and other stakeholders to bring lawsuits against the
FDA to challenge longstanding decisions and policies of the FDA, including FDA’s statutory interpretations of market
exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine the FDA’s authority,
lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review
of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against
the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.
Further, disruptions at the FDA and other government agencies may slow the time required for new drugs to be
reviewed and approved, which could adversely affect our business. For example, over the last several years the US
government has shut down several times, and certain regulatory agencies, including the FDA, have had to furlough
employees and suspend certain activities. The current administration’s freeze on hiring and new return-to-office policy may
disrupt normal operations of federal agencies, including the FDA. Future government shutdowns or other disruptions could
significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory
submissions, or to provide feedback on our clinical development plans, which could have a material adverse effect on our
business. Further, future government shutdowns or other disruptions to normal operations could impact our ability to
access the public markets and obtain the funding necessary to properly capitalize and continue our operations.
We are subject to various laws protecting the privacy, security and confidentiality of certain information and failure to
comply with these data ethics and privacy regulations could adversely affect our business and reputation.
We operate in an environment that relies on the collection, processing, analysis, and interpretation of large sets of
patients’ and other individuals’ personal data, including from our employees and third parties with whom we conduct
business. Numerous countries in which we, our collaboration partners and our third-party contractors, including CROs and
CMOs, operate, manufacture and sell our products have, or are developing, laws protecting personal data and the
individual’s right to privacy and security as well as the transparent and responsible processing of certain personal data and
patient health information.
The legal and regulatory environment of data privacy is diversified, with regional legislation such as the General Data
Protection Regulation in Europe, the Personal Information Protection Law enacted in 2021 and Regulations on the
Administration of Human Genetic Resources of the PRC in China, and other significant privacy legislation, including the
California Consumer Privacy Act and other similar comprehensive state data privacy laws in the US. As the framework
continues to evolve, uncertainty remains due to the absence of clear guidance or case law. This uncertainty, combined with
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limited global harmonization or simplification, makes it challenging for multinational companies to standardize their
approach to privacy and data protection compliance.
Increases in the volume of data processed and advances in technology have resulted in greater focus on data privacy
and the ethical use of personal data, over and above data privacy laws. Companies seeking to foster innovation in artificial
intelligence and other new technologies are faced with evolving decisions from global policymakers on how best to
promote trust in these systems and avoid unintended outcomes or harmful impacts. Failure in our data privacy and ethical
use of personal data could affect our business and reputation.
Additionally, there are several emerging laws concerning the localization of data, restrictions on international transfers,
and data security, which are changing the existing frameworks with which we previously complied. The increasing trend
for data sovereignty affects our ability to drive medical innovation and to effectively operate internationally. Regulatory
uncertainty could result in an operational risk limiting or preventing the transfer of personal data across borders, which may
have an impact on our activities (e.g. clinical trials). Breach of the regulations described above could also carry financial
sanctions, may cause us to become subject to audits, inquiries, whistleblower complaints, adverse media coverage,
investigations, criminal or civil sanctions, damage our reputation and adversely affect our business operations, including, in
particular, our activities that rely on personal data processing.
Our activities, and our business arrangements with third parties, are subject to fraud, abuse and other healthcare laws
and regulations.
Healthcare providers, such as physicians and others, play a primary role in the recommendation and prescription of our
products. Our or our collaboration partners’ arrangements with such persons and third-party payers and our general
business operations expose us or our collaboration partners to broadly applicable fraud and abuse regulations, as well as
other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through
which we research, market, sell and distribute our products. Restrictions under applicable US federal and state and non-US
healthcare laws and regulations include, but are not limited to, the Anti-Kickback Statute, the Beneficiary Inducement
Statute, the HIPAA federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False
Claims Act, the federal transparency requirements under the Physician Payments Sunshine Act and analogous US state
laws. Rules and regulations covering many of the same matters are found in numerous other countries, including in
Denmark, and may be more stringent or result in higher exposures than those in the US.
Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations will
likely continue to be time-consuming and costly. It is possible that governmental authorities will conclude that our business
practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or
other healthcare laws and regulations, in which case we may be subject to significant civil, criminal and administrative
penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from government funded healthcare
programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings
and curtailment of our operations, any of which could substantially disrupt our business. For more information about these
and other applicable regulations, see ‘‘Item 4 – Information on the Company —Government Regulation’’ below.
Enhanced scrutiny of pharmaceutical manufacturer donations to and support of patient assistance programs offered by
charitable foundations may affect us or our collaboration partners.
To help patients afford our products, we and our collaboration partners have implemented, and may implement or
further expand in the future, patient assistance programs. We or our collaboration partners also occasionally make
donations to independent charitable foundations that help financially needy patients. These types of programs designed to
assist patients in affording pharmaceuticals have become the subject of scrutiny. In recent years, some pharmaceutical
manufacturers were named in class action lawsuits challenging the legality of their patient assistance programs and support
of independent charitable patient support foundations under a variety of US federal and state laws. At least one insurer also
has directed its network pharmacies to no longer accept manufacturer co-payment coupons for certain specialty drugs the
insurer identified. Our collaboration partners’ or own patient assistance programs and support of independent charitable
foundations could become the target of similar litigation.
In addition, there has been regulatory review and enhanced government scrutiny of donations by pharmaceutical
companies to patient assistance programs operated by charitable foundations. If we, our collaboration partners or our
vendors or donation recipients are deemed to fail to comply with laws or regulations in the operation of these programs, we
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or such collaboration partner could be subject to damages, fines, penalties or other criminal, civil or administrative
sanctions or enforcement actions. Further, numerous organizations, including pharmaceutical manufacturers, have received
subpoenas from government authorities seeking information related to their patient assistance programs and support. We
cannot ensure that our compliance controls, policies and procedures will be sufficient to protect against acts of our
collaboration partners, employees, business partners or vendors that may violate the laws or regulations of the jurisdictions
in which we operate. Regardless of whether we have complied with the law, a government investigation could negatively
impact our business practices, harm our reputation, divert the attention of management and increase our expenses.
Our operations involve hazardous materials and we and third parties with whom we contract must comply with
environmental laws and regulations.
We are subject to environmental and safety laws and regulations, including those governing the use of hazardous
materials, and the cost of compliance is substantial. Our business activities involve the controlled storage, use and disposal
of hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at
our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of accidental
contamination or injury from these materials in our manufacturing process. We cannot guarantee that the safety procedures
utilized by our collaboration partners and by third-party manufacturers and suppliers with whom we may contract will
comply with the standards prescribed by laws and regulations or will eliminate the risk of accidental contamination or
injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could
exceed our resources. In addition, European, US federal and state or other applicable authorities may curtail our use of
certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex,
change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be
certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage. In the event
of an accident or environmental discharge, we may be held liable for any consequential damage and any resulting claims
for damages, face an interruption of our commercialization efforts, research and development efforts and business
operations, and cause environmental damage resulting in costly clean-up and liabilities under applicable laws and
regulations governing the use, storage, handling and disposal of these materials and specified waste products, which may
exceed our financial resources and may materially adversely affect our business, financial condition, results of operations
and future growth prospects and the value of our ADSs.
Risks Related to Our Ordinary Shares, ADSs and Foreign Private Issuer Status
If we lose our foreign private issuer status in the future, we would incur significant additional costs and expenses.
As a foreign private issuer, we are not required to comply with all the periodic disclosure and current reporting
requirements of the Exchange Act and related rules and regulations. We currently qualify as a foreign private issuer, and
will continue to qualify as a foreign private issuer until, as of June 30 of our most recent fiscal year, (i) more than 50% of
our shares are directly or indirectly owned of record by US residents, and (ii) either (x) the majority of our executive
officers or directors are US citizens or residents, (y) more than 50% of our assets are located in the US, or (z) our business
is administered principally in the US. We estimate that as of the latest determination date, approximately 36% of our
outstanding shares, or 23.0 million shares, were beneficially held by US residents.
Our foreign private issuer status will next be determined as of June 30, 2026. There can be no assurance that we will
not lose our foreign private issuer status in the future.
The regulatory and compliance costs to us under US securities laws if we lose our foreign private issuer status would
be significantly more than the costs we incur as a foreign private issuer, and we would need to devote significantly more
financial, management and other resources to compliance with US securities laws than we currently do, particularly in the
year in which we lose our foreign private issuer status. If we lose our foreign private issuer status, we would be required to
report as a US domestic issuer and be subject to other US securities laws applicable to US domestic issuers. For example,
as a US domestic issuer, we would be required to file periodic reports and registration statements with the SEC on US
domestic issuer forms, which are more detailed and extensive in certain respects than the forms available to us as a foreign
private issuer. We would also be required to prepare our financial statements in accordance with US GAAP and modify
certain of our policies to comply with corporate governance practices applicable to US domestic issuers. In addition, we
may lose our ability to rely upon exemptions from certain corporate governance requirements on US stock exchanges that
are available to foreign private issuers, which could also increase our costs.
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ADS holders do not directly hold our shares, and may not be able to exercise their right to vote the shares underlying
their ADSs.
Holders of our ADSs are not treated as our shareholders and do not have shareholder rights. Our depositary, JPMorgan
Chase Bank, N.A., is the holder of the shares underlying our ADSs. The deposit agreement among us, the depositary, and
all other persons directly and indirectly holding ADSs, sets out ADS holder rights as well as the rights and obligations of
the depositary.
Accordingly, ADS holders may only exercise voting rights with respect to the shares underlying their respective ADSs
in accordance with the provisions of the deposit agreement and not as a direct shareholder of the Company. In order to vote
the shares underlying their ADSs, ADS holders may either withdraw the shares underlying their ADSs or instruct the
depositary to vote the shares underlying such ADSs. However, holders may not know about the meeting sufficiently far
enough in advance to withdraw the underlying shares and, even if they instruct the depositary to vote the shares underlying
their ADSs, Genmab cannot guarantee ADS holders that the depositary will vote in accordance with their instructions.
The depositary will try, as far as practicable, to vote the shares underlying the ADSs as instructed by the ADS holders.
In such an instance, if we ask for holders’ instructions, the depositary, upon timely notice from us, will notify holders of the
upcoming vote and arrange to deliver our voting materials to holders. We cannot guarantee that holders will receive the
voting materials in time to ensure that holders will be able to instruct the depositary to vote their shares or to withdraw their
shares so that they can vote such shares themselves. If the depositary does not receive timely voting instructions from
holders, it may give a proxy to a person designated by us to vote the shares underlying their ADSs. Voting instructions may
be given only in respect of a number of ADSs representing an integral number of shares or other deposited securities. 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 holders may not be able to exercise any right to vote that they may have
with respect to the underlying shares, and there may be nothing they can do if the shares underlying their ADSs are not
voted as they requested. In addition, the depositary is only required to notify holders of any particular vote if it receives
timely notice from us in advance of the scheduled meeting. Our articles of association permit, in the case of general
meetings, notice to be delivered within a relatively short time span, in which case the depositary would not be required to
provide holders with notice of and access to such vote.
ADS holders’ right to receive any dividends that Genmab declares on the shares are more limited than if they were
holding shares.
ADS holders’ right to receive any dividends that Genmab declares on its shares, whether in the form of cash or bonus
securities, are more limited than that of Genmab’s shareholders. For example, Genmab may elect to offer subscription
rights to its shareholders without offering such rights directly to ADS holders as such subscription rights will be offered to
the depositary as shareholder. The depositary has substantial discretion as to what will happen with any offered
subscription rights and may determine that it is not legal or practicable to make such rights available to ADS holders, in
which case it will make such a distribution as it deems permissible and practicable, or it may retain and hold some or all
property to be distributed as deposited securities, without liability for interest thereon or the investment thereof. In the case
of a distribution by Genmab of securities or property other than cash or subscription rights, the depositary may either (i)
distribute such securities or property in any manner it deems equitable and practicable or (ii) to the extent the depositary
deems distribution of such securities or property not to be equitable and practicable, sell such securities or property and
distribute any net proceeds in the same way it distributes cash. If the depositary is unable to distribute or sell any securities
or property distributed by Genmab on the shares, they will lapse, and ADS holders will receive no value. See Exhibit 2.3
“Description of Securities of the Registrant” to this Annual Report on Form 20-F.
ADS holders may be subject to limitations on their ability to cancel their ADSs and withdraw the underlying shares.
Holders’ ADSs, which will be evidenced by American depositary receipts (“ADRs”), 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 holders’ right to cancel their ADSs and withdraw the underlying
shares. Temporary delays in the cancellation of ADSs and withdrawal of the underlying shares may arise due to the
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depositary closing its transfer books or the closing of our share register. In addition, holders may not be able to cancel their
ADSs and withdraw the underlying 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 shares or other deposited securities. For more information, see the description of our securities registered
under Section 12 of the Exchange Act included as an exhibit to this Annual Report on Form 20-F.
By holding or owning an ADR or ADS or an interest therein, holders and beneficial owners each irrevocably agree that
any legal suit, action or proceeding against or involving the depositary and/or us brought by holders or beneficial owners,
arising out of or based upon the deposit agreement, the ADSs or the transactions contemplated therein or thereby,
including, without limitation, claims under the Securities Act, may be instituted only in the United States District Court for
the Southern District of New York (or in the state courts of New York County in New York if either (i) the United States
District Court for the Southern District of New York lacks subject matter jurisdiction over a particular dispute or (ii) the
designation of the United States District Court for the Southern District of New York as the exclusive forum for any
particular dispute is, or becomes, invalid, illegal or unenforceable).
Further, the federal or state courts in the City of New York have non-exclusive jurisdiction to hear and determine
claims brought by the depositary and/or us against or involving holders or beneficial owners arising out of or based upon
the deposit agreement.
ADS holders and beneficial owners, to the fullest extent permitted by the law, waive their right to a jury trial of any
claim they may have against us or the depositary arising out of or relating to our shares, the ADSs or the deposit
agreement, including any claim under the US federal securities laws.
If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver
was enforceable based on the facts and circumstances of that case in accordance with the applicable US state and federal
law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising
under the US federal securities laws has not been finally adjudicated by the US Supreme Court. However, we believe that a
contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New
York, which govern the deposit agreement. In determining whether to enforce a contractual pre-dispute jury trial waiver
provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a jury
trial. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable that potential
holders consult legal counsel regarding the jury waiver provision before investing in the ADSs.
As a result of the jury trial waiver, if any holders or beneficial owners of ADSs bring a claim against us or the
depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under US federal
securities laws, a holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have
the effect of limiting and discouraging lawsuits against us and/or the depositary. If a lawsuit is brought against us and/or
the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which
would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would
have had, including results that could be less favorable to the plaintiff(s) in any such action.
Nevertheless, if this jury trial waiver provision is not enforced, to the extent a court action proceeds, it would proceed
under the terms of the deposit agreement with a jury trial. No condition, stipulation or provision of the deposit agreement
or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any
substantive provision of, or a disclaimer of liability under, the US federal securities laws and the rules and regulations
promulgated thereunder.
If securities or industry analysts publish inaccurate or unfavorable research about our business, the price of the ADSs
and their trading volume could decline.
The trading market for the ADSs and shares will depend in part on the research and reports that securities or industry
analysts publish about us or our business. If one or more of the analysts who covers us downgrades our equity securities,
publishes inaccurate or unfavorable research about our business or expresses a negative opinion regarding the performance
of our securities, or if our clinical trial results or operating performance fail to meet analyst expectations, the price of the
ADSs would likely decline. If one or more of these analysts fails to publish reports on us regularly, or downgrades our
securities, demand for ADSs could decrease, which could cause the price of the ADSs and their trading volume to decline.
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Claims of US civil liabilities may not be enforceable against us.
We are incorporated under the laws of Denmark. Although our wholly owned subsidiary, Genmab US, Inc., has an
office and laboratory space in the US, substantially all of our assets are located outside the US. Some of our directors and
Executive Management reside outside the US. As a result, it may not be possible to effect service of process within the US
upon such persons or to enforce judgments against them or us in US courts, including judgments predicated upon the civil
liability provisions of the US securities laws.
The US and Denmark currently do not have a treaty providing for the reciprocal recognition and enforcement of
judgments (other than arbitration awards) in civil and commercial matters. Consequently, a final judgment for payment
given by a US court, whether or not predicated solely upon US securities laws, would not be enforceable in Denmark. In
order to obtain a judgment that is enforceable in Denmark, the party in whose favor a final and conclusive judgment of the
US court has been rendered will be required to file its claim again with a court of competent jurisdiction in Denmark. The
Danish court will not be bound by the judgment by the US court, but the judgment may be submitted as evidence. It is up
to the Danish court to assess the judgment by the US court and decide if and to what extent the judgment should be
followed. Danish courts are likely to deny claims for punitive damages and may grant a reduced amount of damages
compared to US courts.
Based on the lack of a treaty as described above, US investors may not be able to enforce any judgments obtained in
US courts in civil and commercial matters, including judgments under the US federal securities laws, against us or
members of our Board of Directors or our Executive Management, or certain experts named herein who are residents of
Denmark or countries other than the US.
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 and corporate governance requirements applicable to public companies organized within the US.
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 US. For example, 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
US proxy rules under Section 14 of the Exchange Act. In addition, our directors and Executive Management 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, although they may become subject to the reporting provisions in
March of 2026 absent a timely SEC exemption. Moreover, while we currently publish annual and quarterly reports on our
website pursuant to the rules of Nasdaq Copenhagen and expect to file such financial reports on an annual and quarterly
basis with the SEC, we are not required to file such reports with the SEC as frequently or as promptly as US public
companies and are not required to file quarterly reports on Form 10-Q or current reports on Form 8-K that a US domestic
company would be required to file under the Exchange Act. Accordingly, there may be less publicly available information
concerning our company than there would be if we were not a foreign private issuer. In addition, as a foreign private issuer
and as permitted by the listing requirements of the Nasdaq Stock Market LLC (“Nasdaq”), we will comply with certain
home country corporate governance practices rather than the corporate governance requirements of the Nasdaq Stock
Market.
Risks Related to Tax Matters
If we are a passive foreign investment company for US federal income tax purposes for any taxable year, US holders of
our ADSs could be subject to adverse US federal income tax consequences.
A non-US corporation will be a passive foreign investment company (“PFIC”) for US federal income tax purposes for
any taxable year if either (i) at least 75% of its gross income for such taxable year is “passive income” (as defined in the
relevant provisions of the US Internal Revenue Code of 1986, as amended (“Code”) or (ii) at least 50% of the value of its
assets (generally, based on an average of the quarterly values of the assets) during such year is attributable to assets that
produce or are held for the production of passive income. Based on the current and anticipated value of our assets and the
nature and composition of our income and assets, we do not expect to be a PFIC for US federal income tax purposes for
our current taxable year ending December 31, 2025, nor do we expect to be one in the foreseeable future. However, the
determination of whether we are a PFIC or not according to the PFIC rules is made on an annual basis and will depend on
the nature and composition of our income and assets and the value of our assets from time to time. Therefore, changes in
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the nature and composition of our income or assets or the value of our assets may cause us to become a PFIC. The
determination of the value of our assets (including goodwill not reflected on our balance sheet) may be based, in part, on
the total market value of our shares and ADSs, which is subject to change and may be volatile.
If we are a PFIC for any taxable year during which a US person holds ADSs, certain adverse US federal income tax
consequences could apply to such US person. See “Item 10.E—Taxation—Material US Federal Income Tax
Considerations—Passive Foreign Investment Company Considerations.”
Changes in Danish, Dutch, US or other foreign tax laws or compliance requirements, or the practical interpretation and
administration thereof, could have a material adverse effect on our business, financial condition and results of
operations.
We are affected by various Danish, Dutch, US, Chinese, Japanese and other foreign taxes, including direct and indirect
taxes imposed on our global activities, such as corporate income, withholding, customs, excise/energy, value added, sales,
environmental and other taxes. Significant judgment is required in determining our provisions for taxes and there are many
transactions and calculations where the ultimate tax determination is uncertain.
Changes in Danish or foreign direct or indirect tax laws or compliance requirements, including the practical
interpretation and administration thereof, including in respect to market practices, or otherwise, could have a material
adverse effect on our business, financial condition, results of operations and future growth prospects.
Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in
unanticipated costs, taxes or non-realization of expected benefits.
A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. As
the tax landscape is evolving and our business model is evolving, Danish, Dutch, US, Chinese, Japanese, or another tax
authority could challenge our allocation of income by tax jurisdiction and the amounts paid between our subsidiaries
pursuant to our intercompany arrangements and transfer pricing policies, including amounts paid with respect to our
intellectual property development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where
we believe we have not established a taxable connection, often referred to as a “permanent establishment” under
international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more
jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by
us, in which case, we expect that we might contest such an assessment. Contesting such an assessment may be lengthy and
costly, and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective
tax rate.
Risks Related to the Acquisition of Merus
We may not realize the anticipated benefits from the acquisition of Merus.
The success of the acquisition of Merus will depend, in part, on our ability to realize the anticipated benefits from
successfully combining our and Merus' businesses. We plan on devoting substantial management attention and resources to
integrating our and Merus' businesses so that we can fully realize the anticipated benefits of the acquisition of Merus.
Nonetheless, the acquired Merus business, including petosemtamab, may not be successful, may require greater resources
and investments than originally anticipated or may result in the assumption of unknown or contingent liabilities, which
could have an adverse effect on us or our results of operations.
Potential difficulties we may encounter include the following:
•the inability to successfully combine our and Merus' businesses in a manner that permits us to realize the
anticipated benefits of the acquisition of Merus in the timeframe currently anticipated, or at all;
•the failure to integrate internal systems, programs and internal controls, or applying different accounting policies,
assumptions or judgments to Merus' operational results than Merus applied in the past;
•effectively and efficiently integrating IT and other systems;
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•issues not discovered as part of the transactional due diligence process or unanticipated liabilities or contingencies
of Merus, including employment or severance-related obligations under applicable law or other benefits
arrangements, claims by or amounts owed to vendors or other commercial disputes, cyber incidents and IT failures
or delays, matters related to data privacy, data localization and the handling of personally identifiable information,
and other unknown or contingent liabilities;
•preserving the important licensing, marketing, and other commercial relationships of Merus;
•the complexities associated with managing the combined company;
•the failure to retain key employees of either of the two companies who may be difficult to replace;
•the disruption of each company's ongoing businesses or inconsistencies in services, standards, controls,
procedures and policies;
•potential unknown liabilities associated with the acquisition of Merus; and
•performance shortfalls at one or both of the two companies as a result of the diversion of management's attention
caused by integrating our and Merus' operations.
Any of these risks could adversely affect our ability to maintain relationships with collaboration partners, vendors,
employees and other commercial relationships or adversely affect our or Merus' future operational results. As a result, the
anticipated benefits of the acquisition of Merus may not be realized or at all or may take longer to realize or cost more than
expected, which could adversely affect our business, financial condition, results of operations and growth prospects.
Genmab's ability to realize the anticipated benefits of the acquisition of Merus will depend on its ability to effectively
conduct clinical development of, obtain regulatory approvals for, and profitably commercialize, petosemtamab. We may
fail to realize the anticipated benefits of the acquisition of Merus if we are unable to successfully develop, obtain
regulatory approval for, and commercialize petosemtamab on the currently anticipated timeline, for all of the currently
anticipated therapeutic indications, or at all.
While petosemtamab delivered positive data in certain HNSCC indications in prior Phase I/II trials, there is no
assurance that the currently ongoing Phase III trials will ultimately demonstrate the efficacy of petosemtamab in those
indications at a level that will be sufficient to obtain regulatory approval. A number of companies in the pharmaceutical,
biopharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials even after
obtaining promising results in earlier trials, and we cannot be certain that we will not face similar setbacks with
petosemtamab.
In addition, while petosemtamab has received BTD from the FDA with respect to two HNSCC indications, this
designation does not assure ultimate approval by the FDA. BTD is a process designed to expedite the development and
review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over available therapy on a clinically significant endpoint. Drugs that receive BTD
are eligible for certain procedural benefits as part of the FDA review process, including more frequent meetings with FDA
staff to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval,
more frequent written communication from FDA staff, rolling review of BLA or NDA submissions, intensive guidance on
an efficient drug development program, and organizational commitment involving senior managers. BTD does not,
however, change the scientific and medical standard for approval or the quality of evidence necessary to support approval.
As a result, applications for product candidates granted expedited review or BTD designation may be ultimately denied
based on trial data, trial design or other factors.
Furthermore, even though the available data from petosemtamab Phase I/II trials in certain HNSCC indications may
seem stronger in certain respects than data for certain alternative therapies, there is no completed head-to-head trial that
actually compared the safety and efficacy of petosemtamab with any alternative therapy as part of the same investigational
setting. Separate clinical trials for alternative therapies may differ in trial design and duration, patient population, treatment
protocols and investigators and other important factors, making it difficult to compare data across trials or to draw reliable
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conclusions from such cross-trial comparisons. It is possible that petosemtamab may turn out not to be superior to
alternative therapies in the currently ongoing Phase III trials in HNSCC.
Even if we can successfully progress the clinical development of petosemtamab and obtain the anticipated marketing
approvals, we may not be able to commercialize it on the currently anticipated timeline or at all, to realize its expected
revenue potential, or obtain additional financing, if needed, to fund the commercialization. For more information about the
risks involved in clinical development, regulatory approval and commercialization of new products generally, please see “
– Risks Related to Product Development.” Our ability to realize petosemtamab's potential is also subject to all of the other
risks affecting our business described in this “Risk Factors” section.
Risks Related to Our Indebtedness
Our substantial indebtedness could adversely affect our financial condition.
We have incurred substantial indebtedness which could have a negative impact on our financing options and liquidity
position. Our indebtedness requires us to dedicate a portion of our cash flow to service interest and principal payments and,
if interest rates rise, this amount may increase. The high degree of our debt leverage could have significant consequences,
including the following:
•making it more difficult for us to satisfy our debt obligations;
•limiting our ability to obtain additional financing in the future for working capital, capital expenditures,
acquisitions or other general corporate purposes;
•requiring a substantial portion of our cash flows to be dedicated to debt service payments, instead of other
purposes, thereby reducing the amount of cash flows available for working capital, capital expenditures,
acquisitions and other general corporate purposes;
•limiting our ability to refinance our indebtedness on terms acceptable to us or at all;
•imposing restrictive covenants on our operations;
•placing us at a competitive disadvantage to other, less leveraged competitors; and
•making us more vulnerable to economic downturns and limiting our ability to withstand competitive pressures.
Any of these risks could materially impact our ability to fund our operations or limit our ability to expand our
business, which could have a material adverse effect on our business, financial condition and results of operations.
The terms of the agreements governing our indebtedness may restrict our current and future operations, particularly
our ability to respond to changes or to pursue our business strategies, and could adversely affect our capital resources,
financial condition and liquidity.
The indentures governing our outstanding notes and our credit agreement contain a number of restrictive covenants
that impose significant operating and financial restrictions on us and may limit our ability to engage in acts that may be in
our long-term best interests, including, among other things, restrictions on our ability to:
•incur, assume or guarantee additional indebtedness;
•declare or pay dividends or make other distributions with respect to, or purchase or otherwise acquire or retire for
value, equity interests;
•make any principal payment on, or redeem or repurchase, subordinated debt;
•make loans, advances or other investments;
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•incur liens;
•sell or otherwise dispose of assets, including capital stock of subsidiaries;
•enter into sale and lease-back transactions;
•consolidate or merge with or into, or sell all or substantially all of the assets of the Issuers to, another person; and
•enter into transactions with affiliates.
In addition, our credit agreement requires us to comply with certain financial maintenance covenants. Our ability to
satisfy these financial maintenance covenants can be affected by events beyond our control and we cannot provide
assurance that we will meet them.
A breach of the covenants under the credit agreement and the indentures governing our outstanding notes could result
in an event of default under the applicable indebtedness, which, if not cured or waived, could result in us having to repay
our borrowings before their due dates. Any such default may allow the holders to accelerate the related debt and may result
in the acceleration of any other debt to which a cross-acceleration or cross-default provision applies. If we are forced to
refinance these borrowings on less favorable terms or if we experience difficulty refinancing the debt prior to maturity, our
results of operations or financial condition could be materially affected. In addition, an event of default under our credit
agreement may permit the lenders to terminate all commitments to extend further credit. Furthermore, if we are unable to
repay the amounts due and payable under our credit agreement or our outstanding notes, the lenders or holders of our
outstanding notes may be able to proceed against the collateral granted to them to secure that indebtedness. In the event
lenders or holders of our outstanding notes accelerate the repayment of such borrowings, we cannot assure you that we will
have sufficient assets to repay such indebtedness.