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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

For the fiscal year ended December 31, 2024 or

For the transition period from to

Commission File Number: 001-12400

INCYTE CORPORATION

(Exact name of registrant as specified in its charter)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act:

None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes o No x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

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

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

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b) . o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

The aggregate market value of Common Stock held by non-affiliates (based on the closing sale price on The Nasdaq Global Select Market on June 28, 2024) was approximately $9.9 billion.

As of February 3, 2025 there were 193,524,350 shares of Common Stock, $.001 par value per share, outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Items 10 (as to directors and Section 16(a) Beneficial Ownership Reporting Compliance), 11, 12, 13 and 14 of Part III incorporate by reference information from the registrant’s proxy statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for the registrant’s 2025 Annual Meeting of Stockholders to be held on June 10, 2025.

Table of Contents

Forward-Looking Statements

This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future periods, future events or our future operating or financial plans or performance. Often, these statements include the words “believe,” “expect,” “target,” “anticipate,” “intend,” “plan,” “seek,” “estimate,” “potential,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” or “may,” or the negative of these terms, and other similar expressions. These forward-looking statements include statements as to:

• the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI*®/JAKAVI®* (ruxolitinib), PEMAZYRE*®* (pemigatinib), ICLUSIG*®* (ponatinib), MONJUVI*®(tafasitamab-cxix)* / MINJUVI*®* (tafasitamab), OPZELURA*®* (ruxolitinib) cream, ZYNYZ*®* *(retifanlimab-dlwr) and NIKTIMVOTM* (axatilimab);

• our plans to further develop our operations outside of the United States;

• conducting clinical trials internally, with collaborators, or with clinical research organizations;

• our collaboration and strategic relationship strategy, and anticipated benefits and disadvantages of entering into collaboration agreements;

• our licensing, investment and commercialization strategies, including our plans to commercialize our drug products and drug candidates;

• the regulatory approval process, including obtaining U.S. Food and Drug Administration and other international regulatory authorities’ approval for our products in the United States and abroad;

• the safety, effectiveness and potential benefits and indications of our drug candidates and other compounds under development;

• the timing and size of our clinical trials; the compounds expected to enter clinical trials; timing of clinical trial results;

• our ability to manage expansion of our drug discovery and development operations;

• future required expertise relating to clinical trials, manufacturing, sales and marketing;

• obtaining and terminating licenses to products, drug candidates or technology, or other intellectual property rights;

• the receipt from or payments pursuant to collaboration or license agreements resulting from milestones or royalties;

• plans to develop and commercialize products on our own;

• plans to use third-party manufacturers;

• plans for our manufacturing operations;

• expected expenses and expenditure levels; expected uses of cash; expected revenues and sources of revenues, including milestone payments; expectations with respect to inventory;

• expectations with respect to reimbursement for our products;

• the expected impact of recent accounting pronouncements and changes in tax laws;

• expected losses; fluctuation of losses; currency translation impact associated with non-U.S. operations and collaboration royalties;

• our profitability; the adequacy of our capital resources to continue operations;

• the need to raise additional capital;

• the costs and other financial impacts associated with resolving matters in litigation and governmental proceedings;

• our expectations regarding competition;

• our investments, including anticipated expenditures, losses and expenses; and

• our patent prosecution and maintenance efforts.

These forward-looking statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. These risks and uncertainties could cause actual results to differ materially from those projected and include, but are not limited to:

• our ability to successfully commercialize our drug products and drug candidates;

• our ability to obtain, or maintain at anticipated levels, coverage and reimbursement for our products from government health administration authorities, private health insurers and other organizations;

• our ability to establish and maintain effective sales, marketing and distribution capabilities;

• the risk of reliance on other parties to manufacture our products, which could result in a short supply of our products, increased costs, and withdrawal of regulatory approval;

• our ability to maintain regulatory approvals to market our products;

• our ability to achieve a significant market share in order to achieve or maintain profitability;

• the risk of civil or criminal penalties if we market our products in a manner that violates health care fraud and abuse and other applicable laws, rules and regulations;

• our ability to discover, develop, formulate, manufacture and commercialize our drug candidates;

• the risk of unanticipated delays in, or discontinuations of, research and development efforts;

• the risk that previous preclinical testing or clinical trial results are not necessarily indicative of future clinical trial results;

• risks relating to the conduct of our clinical trials, including geopolitical risks;

• changing regulatory requirements;

• the risk of adverse safety findings;

• the risk that results of our clinical trials do not support submission of a marketing approval application for our drug candidates;

• the risk of significant delays or costs in obtaining regulatory approvals;

• risks relating to our reliance on third-party manufacturers, collaborators, and clinical research organizations;

• risks relating to the development of new products and their use by us and our current and potential collaborators;

• risks relating to our inability to control the development of out-licensed compounds or drug candidates;

• risks relating to our collaborators’ ability to develop and commercialize drug products and the drug candidates licensed from us;

• costs associated with prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights;

• our ability to maintain or obtain adequate product liability and other insurance coverage;

• the risk that our drug candidates may not obtain or maintain regulatory approval;

• the impact of technological advances and competition, including potential generic competition;

• our ability to compete against third parties with greater resources than ours;

• risks relating to changes in pricing and reimbursement in the markets in which we may compete;

• risks relating to governmental healthcare reform efforts, including efforts to control, set or cap pricing for our commercial drugs in the U.S. and abroad;

• competition to develop and commercialize similar drug products;

• our ability to obtain and maintain patent protection and freedom to operate for our discoveries and to continue to be effective in expanding our patent coverage;

• the impact of changing laws on our patent portfolio;

• developments in and expenses relating to litigation and governmental proceedings;

• our ability to in-license drug candidates or other technology;

• unanticipated delays or changes in plans or regulatory agency interactions or other issues relating to our large molecule production facility;

• our ability to integrate successfully acquired businesses, development programs or technology;

• our ability to obtain additional capital when needed;

• fluctuations in net cash provided and used by operating, financing and investing activities;

• our ability to analyze the effects of new accounting pronouncements and apply new accounting rules;

• risks relating to our ability to sustain profitability;

• risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of Ukraine and conflicts in the Middle East; and

• the risks set forth under “Risk Factors.”

Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by federal securities laws, we undertake no obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

In this report all references to “Incyte,” “we,” “us,” “our” or the “Company” mean Incyte Corporation and our subsidiaries, except where it is made clear that the term means only the parent company.

Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered trademarks and NIKTIMVO is our trademark. We also refer to trademarks of other corporations and organizations in this Annual Report on Form 10-K.

Summary Risk Factors

Our business is subject to numerous risks and uncertainties that could affect our ability to successfully implement our business strategy and affect our financial results. You should carefully consider all of the information in this report and, in particular, the following principal risks and all of the other specific factors described in Item 1A. of this report, “Risk Factors,” before deciding whether to invest in our company.

• We depend heavily on JAKAFI/JAKAVI (ruxolitinib), and if we are not able to maintain revenues from JAKAFI/JAKAVI or those revenues decrease, our business may be materially harmed.

• If we or our collaborators are unable to obtain, or maintain at anticipated levels, coverage and reimbursement for our products from government and other third-party payors, our results of operations and financial condition could be harmed.

• A limited number of specialty pharmacies and wholesalers represent a significant portion of revenues from JAKAFI and most of our other products, and the loss of, or significant reduction in sales to, any one of these specialty pharmacies or wholesalers could harm our operations and financial condition.

• If we are unable to establish and maintain effective sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we will not be able to successfully commercialize our products.

• If we fail to comply with applicable laws and regulations, we could lose our approval to market our products or be subject to other governmental enforcement activity.

• If the use of our products harms or is perceived to harm patients, our regulatory approvals could be revoked or otherwise negatively impacted or we could be subject to costly product liability claims.

• If we market our products in a manner that violates various laws and regulations, we may be subject to civil or criminal penalties.

• Competition for our products could harm our business and result in a decrease in our revenue.

• We or our collaborators may be unsuccessful in discovering and developing drug candidates, and we may spend significant time and money attempting to do so, in particular with our later stage drug candidates.

• If we or our collaborators are unable to obtain regulatory approval in and outside of the United States for drug candidates, we and our collaborators will be unable to commercialize those drug candidates.

• Health care reform measures could impact the pricing and profitability of pharmaceuticals, and adversely affect the commercial viability of our or our collaborators’ products and drug candidates.

• Conflicts between us and our collaborators or termination of our collaboration agreements could limit future development and commercialization of our drug candidates and harm our business.

• If we are unable to establish collaborations to fully exploit our drug discovery and development capabilities or if future collaborations are unsuccessful, our future revenue prospects could be diminished.

• If we fail to enter into additional in-licensing agreements or if these arrangements are unsuccessful, we may be unable to increase our number of successfully marketed products and our revenues.

• Business disruptions, including those resulting from public health pandemics, natural disasters, and other geopolitical events, could adversely affect our business and results of operations.

• Even if one of our drug candidates receives regulatory approval, we may determine that commercialization would not be worth the investment.

• We have limited capacity to conduct preclinical testing and clinical trials, and our resulting dependence on other parties could result in delays in and additional costs for our drug development efforts.

• Our reliance on others to manufacture our drug products and drug candidates could result in drug supply constraints, delays in clinical trials, increased costs, and withdrawal or denial of regulatory approvals.

• If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business.

• The illegal distribution and sale by third parties of counterfeit or unfit versions of our or our collaborators’ products or stolen products could harm our business and reputation.

• As most of our drug discovery and development operations are conducted at our headquarters in Wilmington, Delaware, the loss of access to this facility would negatively impact our business.

• If we lose any of our key employees or are unable to attract and retain additional personnel, our business and ability to achieve our objectives could be harmed.

• If we fail to manage our growth effectively, our ability to develop and commercialize products could suffer.

• We may acquire businesses or assets, form joint ventures or make investments in other companies that may be unsuccessful, divert our management’s attention and harm our operating results and prospects.

• Risks associated with our operations outside of the United States could adversely affect our business.

• If product liability lawsuits are brought against us, we could face substantial liabilities and may be required to limit commercialization of our products, and our results of operations could be harmed.

• Because our activities involve the use of hazardous materials, we may be subject to claims relating to improper handling, storage or disposal of these materials that could be time consuming and costly.

• We expect to continue to incur significant expenses to discover and develop drugs, which could result in future losses and impair our achievement of and ability to sustain profitability in the future.

• If we are unable to raise additional capital in the future when we require it, our efforts to broaden our product portfolio or commercialization efforts could be limited.

• Our marketable securities and equity investments are subject to risks that could adversely affect our overall financial position, and tax law changes could adversely affect our results of operations and financial condition.

• If we are unable to achieve milestones, develop product candidates to license or renew or enter into new collaborations, our royalty and milestone revenues and future prospects for those revenues may decrease.

• Any arbitration or litigation involving us and regarding intellectual property infringement claims could be costly and disrupt our drug discovery and development efforts.

• Our inability to adequately protect or enforce our proprietary information may result in loss of revenues or otherwise reduce our ability to compete.

• If the effective term of our patents is decreased or if we need to refile some of our patent applications, the value of our patent portfolio and the revenues we derive from it may be decreased.

• International patent protection is particularly uncertain and costly, and our involvement in opposition proceedings may result in the expenditure of substantial sums and management resources.

• Significant disruptions of information technology systems, breaches of data security, or unauthorized disclosures of sensitive data could harm our business and subject us to liability or reputational damage.

• Increasing use of social media and new technology could give rise to liability, breaches of data security, or reputational damage, which could harm our business and results of operations.