Incyte (INCY) 10-K risk factor changes: FY2023 vs FY2022

While we also sell [removed: ICLUSIG in the European Union, or EU,] [added: our] and [added: our licensors’] other [removed: countries for the treatment of certain types of leukemia, PEMAZYRE in the United States, Europe and Japan for the treatment of certain metastatic cholangiocarcinoma indications, as well as for certain blood cancer indications in the United States, MONJUVI in the United States and MINJUVI in the European Union for the treatment of certain lymphoma indications, and] [added: approved products ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI,] OPZELURA [removed: in the Unites States for the treatment of certain indications of atopic dermatitis] and [removed: vitiligo,] [added: ZYNYZ] and our exclusive licensees sell OLUMIANT [removed: (baricitinib) for the treatment of specified rheumatoid arthritis] and [removed: atopic dermatitis indications and TABRECTA for the treatment of a certain type of non-small cell lung cancer,] [added: TABRECTA,] we anticipate that JAKAFI product sales will continue to contribute a significant percentage of our total revenues over the next several years.

- our ability to develop, obtain regulatory approval for and commercialize ruxolitinib in the United States for additional indications or in combination with other therapeutic [removed: modalities.][added: modalities; and]

The costs of JAKAFI, ICLUSIG, PEMAZYRE, [removed: MONJUVI/MINJUVI and] [added: MONJUVI/MINJUVI,] OPZELURA [added: and ZYNYZ] are not insignificant and almost all patients will require some form of third-party coverage to afford their cost.

- pressure by employers on private health insurance plans to reduce costs or moderate cost increases, as well as continued public scrutiny of the price of drugs and other healthcare costs; [removed: and]

- consolidation of third-party payors and continued initiatives of government and other third-party payors to reduce costs by seeking price discounts or rebates, reducing reimbursement rates or imposing restrictions on access to or coverage of particular drugs based on perceived [removed: value.][added: value;]

[added: In addition, in many instances, certain PBMs, other similar organizations] and third party payors may exert negotiating leverage by requiring incremental rebates, discounts or other concessions from manufacturers in order to maintain formulary positions, which could continue to result in higher gross to net deductions for affected products.

[removed: In this regard,] while we have entered into agreements with a number of PBMs, we are in the process of negotiating agreements with additional PBMs and payor accounts to provide rebates to those entities related to formulary coverage for OPZELURA, and we cannot guarantee that we will be able to agree to or maintain acceptable coverage terms with these PBMs and other third party payors.

” If government and other third-party payors refuse to provide coverage and reimbursement with respect to our products, determine to provide a lower level of coverage and reimbursement than anticipated, reduce previously approved levels of coverage and reimbursement, or delay reimbursement [removed: payments due to budgetary constraints relating to the COVID-19 pandemic,] [added: payments,] then our pricing or reimbursement for our products may be affected and our product sales, results of operations or financial condition could be harmed.

Successful commercialization of our drug candidates for dermatology indications requires us to establish new physician and payor relationships, PBM and pharmacy network relationships, reimbursement strategies and governmental [removed: interactions.][added: interactions, separate from our existing capabilities for oncology indications.]

In addition, in September 2021, the FDA [removed: approved a] [added: updated] labeling [removed: update] for [removed: JAKAFI, adding] [added: JAKAFI and other JAK inhibitor drugs to include] warnings of increased risk of major adverse cardiovascular events, thrombosis, and secondary malignancies related to another JAK-inhibitor treating rheumatoid arthritis, a condition for which JAKAFI is not indicated.

The testing of JAKAFI, ICLUSIG, PEMAZYRE, [removed: MONJUVI/MINJUVI] [added: MONJUVI/MINJUVI, OPZELURA] and [removed: OPZELURA,] [added: ZYNYZ,] the manufacturing, marketing and sale of JAKAFI, PEMAZYRE and OPZELURA and the marketing and sale of [removed: ICLUSIG and] [added: ICLUSIG,] MONJUVI/MINJUVI [added: and ZYNYZ] expose us to product liability and other risks.

Similar results could occur with respect to our commercialization of ICLUSIG, PEMAZYRE, [removed: MONJUVI/MINJUVI] [added: MONJUVI/MINJUVI, OPZELURA] and [removed: OPZELURA.][added: ZYNYZ.]

Factors similar to those listed above also apply to our [removed: collaborator Novartis for jurisdictions in which it has development and commercialization rights, to ICLUSIG for jurisdictions outside the United States, to our collaborator Lilly for all jurisdictions and to our collaborator Innovent for PEMAZYRE] [added: license collaborators] in the jurisdictions in which [removed: it has] [added: they have] development and commercialization rights.

Although we believe that our promotional materials for physicians do not constitute improper [removed: promotion of JAKAFI,] [added: promotion,] the FDA or other agencies may disagree.

If the FDA or another agency determines that our promotional materials or other activities constitute improper [removed: promotion of JAKAFI,] [added: promotion,] it could request that we modify our promotional materials or other activities or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties.

[removed: The] [added: These Physician Payment] Sunshine provisions and similar laws and regulations in other jurisdictions where we do business require manufacturers to publicly report certain payments or other transfers of value made to physicians and teaching hospitals.

Competitors and potential competitors for PEMAZYRE [added: and ZYNYZ] include major pharmaceutical and biotechnology companies, as well as specialty pharmaceutical firms.

Competitors for OPZELURA include existing over-the-counter topical treatments, prescription topical treatments, including generic versions, such as tacrolimus, pimecrolimus, topical steroids, and EUCRISA (crisaborole) from Pfizer Inc., as well as oral and injectable therapies such as prednisone and other oral steroids, injectable DUPIXENT (dupilimab) from Sanofi and Regeneron Pharmaceuticals, Inc., and oral CIBINQO (abrocitinib) from Pfizer Inc. and RINVOQ (upadacitinib) from AbbVie Inc. [added: In September 2023, we received a notice letter regarding an ANDA that requested approval to market a generic version of OPZELURA and purported to challenge patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.]

Our global operations expose us to risks associated with public health epidemics and pandemics, such as the COVID-19 [removed: pandemic that has spread globally and continues with the proliferation of new variants.][added: pandemic.]

The extent to which [removed: the COVID-19] [added: a public health] pandemic and the measures taken to limit [removed: COVID-19’s] [added: the disease's] spread [added: can] impact our operations and those of our suppliers, collaborators, service providers and healthcare organizations serving patients, as well as demand for our drug products, will depend on [removed: future] developments, [removed: which] [added: that] are highly [removed: uncertain and cannot be predicted with confidence,] [added: uncertain,] including the duration of the outbreak and any [removed: future resurgence of the outbreak, additional or modified] [added: related] government [removed: actions, including any further restrictions or reopening of local, state or national social or economic activity, new information that may emerge concerning the severity of COVID-19 and the actions taken to contain COVID-19 or treat its impact, among others.][added: actions.]

As a result of the COVID-19 pandemic, we [removed: have experienced] [added: experienced,] and [added: as a result of future pandemics we] may in the future experience disruptions that could severely impact our business, results of operations and financial [removed: condition, including the following:][added: condition.]

[removed: Having] [added: In addition, having] a [removed: significant] portion of our employees work [removed: from home] [added: remotely] can strain our [removed: information technology] [added: IT] infrastructure, which may affect our ability to operate effectively, may make us more susceptible to communications disruptions, and expose us to greater cybersecurity risks.

- [removed: The outbreak and measures taken to limit the spread of] [added: negative impacts on] the [removed: outbreak, especially if prolonged, could also disrupt our] [added: global] supply chain [removed: or limit] [added: which may affect] our ability to obtain sufficient materials for our drug products and product [removed: candidates, which could adversely affect our revenues and clinical trial timelines.][added: candidates.]

[removed: And, for JAKAFI, while] [added: While] our strategy is to maintain [added: at] a [added: minimum] 24 [removed: month] [added: months] stock of [removed: active pharmaceutical ingredient, or] [added: ruxolitinib phosphate] API, inclusive of finished product, ruxolitinib phosphate might be used by us either to make JAKAFI or [added: OPZELURA or] for ruxolitinib drug candidates in clinical trials.

[removed: We do not yet know the full extent] [added: The ultimate impact] of [added: a public health epidemic or pandemic is highly uncertain, but the] potential impacts or delays on our or our collaborators’ businesses, our revenues, including milestone and royalty revenues from our collaborators, our and our collaborators’ clinical trials, healthcare systems or the global economy as a [removed: whole.][added: whole could have a material adverse impact on our business, results of operations, and financial condition.]

[removed: We] [added: Despite investing significant resources, we] may not be successful in discovering, developing, or commercializing additional drug products or our existing drug products in new indications.

For example, in April 2018, we along with Merck [removed: stopped] [added: announced that] the ECHO-301 study [removed: with epacadostat,] [added: had been stopped] and we also significantly downsized the epacadostat development [removed: program.][added: program and in January 2020 we stopped our Phase 3 trial of itacitinib for the treatment of acute graft-versus-host-disease.]

[removed: If] [added: Even if] a [removed: product is developed but] [added: drug candidate received marketing approval, it may] not [removed: approved or marketed,] [added: be able to achieve market acceptance] or [removed: becomes approved for a narrower set of indications than those for which we initially conducted clinical trials,] [added: compete successfully with competitors’ products and] we may have spent significant amounts of time and money on it without achieving potential returns initially anticipated, which could adversely affect our operating results and financial condition as well as our business plans.

For example, the FDA has in the past required, and could in the future require, that we or our collaborators conduct additional trials of any of our drug candidates, which would result in [removed: delays.][added: delays and could result in our termination of a drug development program.]

[removed: For example, a provision in the American Rescue Plan Act of 2021 that] [added: It] is expected [removed: to be] [added: that this provision, as] implemented [removed: in 2024] [added: by the Centers for Medicare and Medicaid Services, or CMS,] will have the effect of increasing [removed: the] Medicaid rebate [removed: liability for some] [added: liability, particularly in the case of] medicines that [removed: increase prices] [added: have experienced price increases at a rate] in excess of inflation.

In addition, we have licensed [removed: to CMS, Innovent, InnoCare and Maruho] certain Asian rights to some of our drug products and clinical stage [removed: compounds.][added: compounds to other collaborators.]

For example, in addition to our Novartis, Lilly, [removed: Innovent, InnoCare, Maruho] and [removed: CMS] [added: our other existing] collaborations, we are evaluating strategic relationships with respect to several of our other programs.

In addition to establishing collaborative or license arrangements under which other parties license our drug candidates for development and commercialization or under which we study our drug candidates in combination with such parties’ compounds or biologics, we may explore opportunities to develop our clinical pipeline by in-licensing drug candidates or therapeutics targets that fit within our focus on oncology, such as our collaborations with [removed: Agenus Inc.,] [added: Agenus,] MacroGenics, [removed: Inc.,] Merus [removed: N.V., MorphoSys, Syros Pharmaceuticals, Inc.,] and Syndax Pharmaceuticals, [removed: Inc.,] or explore [added: additional opportunities to further develop and commercialize existing drug candidates in specific jurisdictions, such as our June 2016 acquisition of the development and commercialization rights to ICLUSIG in certain countries.]

[removed: For example, in January 2022, we decided to opt-out of the continued development with Merus of MCLA-145, which was the most advanced compound under our collaboration with Merus, and in September 2022, we decided to terminate our collaboration with Calithera Biosciences, Inc.] If we make or incur contractual obligations to make significant upfront payments in connection with licenses for late-stage drug candidates, [removed: as we did in March 2020 in connection with the effectiveness of our collaboration agreement with MorphoSys,] and if any of those drug candidates do not receive marketing approval or commercial sales as anticipated or we have to fund additional clinical trials before marketing approval can be obtained, we will have expended significant funds that might otherwise be applied for other uses or have to expend funds that were not otherwise budgeted or anticipated in connection with the collaboration, and such developments could have a material adverse effect on our stock price and our ability to pursue other transactions.

[removed: Conflicts may arise between our collaborators and licensees and us, or our collaborators and licensees may] choose to terminate their agreements with us, which may adversely affect our business,” conflicts or other issues may arise with our licensors.

Regulatory agencies [removed: may] also [added: may] require additional clinical trials or testing, and the drug product may be recalled or may be subject to reformulation, additional studies, changes in labeling, warnings to the public and negative publicity.

Further, we may decide not to continue to commercialize a product if the market does not accept the product because it is too expensive or because third [removed: parties] [added: parties,] such as insurance companies or Medicare, will not cover it for substantial reimbursement.

Even if we [removed: or our collaborators] are successful in [removed: gaining] [added: obtaining] regulatory [removed: approval of any of our or our collaborators’ drug candidates in addition to JAKAFI, OLUMIANT, PEMAZYRE, MONJUVI/MINJUVI] [added: approvals for manufacturing] and [removed: OPZELURA or acquire rights to approved] [added: commercializing] drug products in addition to [added: JAKAFI,] ICLUSIG, [added: PEMAZYRE, MONJUVI/MINJUVI, OPZELURA and ZYNYZ,] we may [removed: not generate significant product revenues] [added: incur losses] if [removed: these] [added: our] drug products do not [removed: achieve an adequate level of acceptance.][added: generate significant revenues.]

We do not currently operate manufacturing facilities for [added: most of our] clinical or commercial [removed: production of] [added: products, including] JAKAFI, PEMAZYRE, [removed: OPZELURA] [added: ICLUSIG] and [removed: most of] [added: OPZELURA, and] our [removed: other] drug [removed: candidates or for ICLUSIG.][added: candidates.]

[removed: In addition,] [added: While working to increase our own manufacturing capacity through our Swiss bioplant site,] we expect to continue to rely on third parties for the manufacture of [added: clinical and] commercial supplies of raw materials, API and finished drug product for any drugs that we successfully develop.

- the effects of a public health pandemic or epidemic such as the COVID-19 pandemic or of adverse geopolitical events, regulatory, legislative or administrative developments.

- pressure on healthcare budgets resulting from macroeconomic factors such as inflation, rising interest rates and the economic effects of geopolitical conflicts; and

- the increasing number of hospitals and other covered entities that are eligible to participate in the U.S. 340B drug pricing program, which requires drug manufacturers such as our company to sell drugs to those entities at discounted prices in order for those drugs to be covered by Medicaid.

In this regard,

We are continuing to establish and maintain sales, marketing and distribution capabilities for OPZELURA.

The notice letter does not challenge ruxolitinib nor the ruxolitinib phosphate composition of matter patents, providing patent coverage (with pediatric extension) until December 2028.

To date, to our knowledge, the FDA has taken no action with respect to this ANDA.

From time to time we and our collaborators have experienced events that have resulted in delays, setbacks and terminations of drug development programs.

Also, in March 2023, we received a complete response letter for ruxolitinib extended-release (XR) tablets, which identified additional requirements for approval.

For example, the American Rescue Plan Act of 2021 includes a provision that became effective in January 2024 that eliminates the statutory cap on rebates that drug manufacturers pay to Medicaid.

For example, in January 2022, we decided to opt-out of the continued development with Merus of MCLA-145, which was the most advanced compound under our collaboration with Merus, and in September 2022, we decided to terminate our collaboration with Calithera Biosciences.

Conflicts may arise between our collaborators and licensees and us, or our collaborators and licensees may

These disruptions can include the following:

- the imposition of shelter-in-place orders and work-from-home policies that could affect our research and development activities and access to our laboratory space;

- disruptions in our sales and marketing activities;

- negative impacts on the demand for our products as a result of a decrease in patient visits to healthcare professionals and the prioritization of hospital resources for a future pandemic;

- negative impacts on our clinical trials as a result of delays in site initiation, patient screening, patient enrollment, and monitoring and data collection;

- slower response times by the FDA and comparable foreign regulatory agencies for the review and potential approvals of our drug candidate applications; and

Our current manufacturing strategy for these products and drug candidates is to contract with third parties to manufacture the related raw materials, active pharmaceutical ingredient (API), and finished drug product.

We do have a biologics production facility located in Yverdon, Switzerland, currently registered for MINJUVI drug substance manufacturing.

For ZYNYZ, together with our collaborator MacroGenics, we are responsible for the sourcing and manufacturing of ZYNYZ.

Our suppliers, which operate in multiple countries around the world, could also experience disruptions in their operations resulting from various factors, including equipment malfunction or failure, regulatory requirements or actions, raw material shortages, labor disputes or shortages, including from the effects of public health pandemics, cyberattacks, natural and other disasters, and wars or other geopolitical events.

In addition, one or more of our third party contract manufacturers could be acquired and its contract manufacturing operations could be ceased or curtailed.

Any increases in the cost of our

drug candidates or drug products, whether through conditions affecting the cost and availability of raw materials, such as inflation, decreases in available manufacturing capacity, or otherwise, would adversely affect our results of operations.

For example, February 2024, we entered into a purchase agreement with MorphoSys under which we acquired rights to tafasitamab (MONJUVI/MINJUVI) that resulted in our holding exclusive global development and commercialization rights to tafasitamab.

These strategic transactions are complex, time consuming and expensive and entail numerous risks, including:

- unanticipated costs, delays or other operational or financial problems related to integrating the products, product candidates, technologies, business operations, systems, controls and personnel of an acquired company or asset with our company;

- failure to successfully develop and commercialize acquired products, product candidates or technologies or to achieve other strategic objectives;

- delays or inability to progress preclinical programs into clinical development or unfavorable data from clinical trials evaluating acquired or licensed products or product candidates;

- disruption of our ongoing business and diversion of our management’s and employees’ attention from ongoing development of our existing business and other opportunities and challenges;

- inability to achieve planned synergies or cost savings;

- the potential loss of key employees of an acquired company;

- entry into markets in which we have no or limited direct prior experience or where competitors in such markets have stronger market positions;

- uncertainties in our ability to maintain key business relationships of business we acquire;

- exposure to unknown or contingent liabilities or the incurrence of unanticipated expenses, including those with respect to intellectual property, pre-clinical or clinical data, safety, compliance or internal controls, and including as a result of the failure of the due diligence processes to identify significant problems, liabilities or challenges of an acquired company or asset;

- the risk that acquired businesses may have differing or inadequate cybersecurity and data protection controls; and

- exposure to litigation or other claims in connection with, or inheritance of claims or litigation risk as a result of, the strategic transaction, including claims from terminated employees, customers, former equity holders or other third parties.

Acquisition transactions may be subject to regulatory approvals or other requirements that are not within our control.

We may be unable to obtain these regulatory or other approvals, and closing conditions required in connection with our acquisition transactions may be unable to be satisfied or waived, which could result in our inability to complete the planned acquisition transactions.

JAKAFI was approved by the U.S. Food and Drug Administration, or FDA, in November 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, in December 2014 for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea, which we refer to as uncontrolled polycythemia vera, in May 2019 for the treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older and in September 2021 for the treatment of steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older.

Although we have received regulatory approval for these indications, such approval does not guarantee future revenues.

- the effects of the COVID-19 pandemic, any associated quarantine, travel restriction, stay-at-home or shutdown orders, guidelines or practices, and any disruption in our supply chain for JAKAFI on our ability to provide marketing and distribution support for JAKAFI, our ability to produce sufficient quantities of JAKAFI that meet all applicable quality standards, patient demand (including new patient prescriptions and hesitancy of patients to make office visits) and other risks detailed further below under “—Other Risks Relating to our Business—Public health epidemics, such as the COVID-19 pandemic, could adversely affect our business, results of operations, and financial condition”;

- the label and promotional claims allowed by the FDA;

In addition, in many instances, certain PBMs, other similar organizations

We are working to establish and maintain sales, marketing and distribution capabilities for OPZELURA that will generally be separate from our existing capabilities for oncology indications, and we have no prior experience in commercializing products for dermatology indications.

We market JAKAFI for intermediate or high-risk myelofibrosis, uncontrolled polycythemia vera and acute graft-versus-host disease and provide promotional materials to physicians regarding the use of JAKAFI for these indications.

Similar risks exist for our marketing of PEMAZYRE and OPZELURA and our collaborator MorphoSys’s marketing of MONJUVI.

- When the COVID-19 pandemic commenced, to protect the health of our employees and their families, and our communities, in accordance with – and in some cases in advance of – direction from state and local government authorities, we limited access to our facilities and a significant percentage of our personnel worked remotely.

In the event that governmental authorities were to re-establish workplace restrictions, our employees conducting research and development activities may not be able to access our laboratory space or access may be limited, and our research and development activities may be significantly limited or curtailed, possibly for an extended period of time.

These research and development activities could include completing Investigational New Drug (IND)/Clinical Trial Application (CTA)-enabling studies, our ability to select future development candidates, and initiation of additional clinical trials for our development programs.

- Our sales and marketing activities, including our interactions with healthcare professionals, have been limited and made more difficult by government or employer imposed work from home orders and travel and workplace visitor restrictions resulting from measures to address the COVID-19 pandemic, as well as employee-initiated remote work and travel limitations resulting from, among other things, the spread of the COVID-19 variants.

In addition, demand for our products has been affected by decreases in new patients, which we believe resulted in large part from decreases in patient visits to healthcare professionals and prioritization of hospital resources for the COVID-19 pandemic, resulting in decreases in disease screening and diagnosis.

We cannot predict the effects on patient demand or future sales if there are prolonged quarantines, work from home orders, travel restrictions or surges in COVID-19 cases.

- Our clinical trials have been and will likely continue to be affected by delays in site initiation, patient screening, patient enrollment, and monitoring and data collection as a result of prioritization of hospital resources for the COVID-19 pandemic, difficulty in recruiting and retaining healthcare providers and staff due to their diversion toward treating COVID-19 patients, the potential unwillingness of patients to enroll or continue in clinical trials for fear of exposure to COVID-19 at sites, and the inability to access sites for initiation and monitoring.

In addition, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt health services, we may be unable to obtain blood samples for testing, and we may not be able to provide the trial drug candidate to patients.

Also, we rely on independent clinical investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, and the COVID-19 pandemic has affected and may continue to affect their ability to devote sufficient time and resources to our programs or to travel to sites to perform work for us.

- Regulatory agencies globally have experienced disruptions in their operations as a result of the coronavirus pandemic.

The FDA and comparable foreign regulatory agencies may have slower response times or be under-resourced to continue to monitor our clinical trials and, as a result, review, inspection, and other timelines may be materially delayed.

If any of these disruptions occur or continue to occur, we cannot predict how long they may last.

Our drug candidate application reviews and potential approvals could be impacted or delayed by these disruptions, if they occur or continue to occur.

Currently, our supply chain for our drug products and product candidates depends on operations by us and by other companies in multiple countries around the world, and the effects of the COVID-19 pandemic on any or all of these countries is uncertain and unpredictable and potential disruption is possible.

In addition, our third-party manufacturers might experience capacity constraints and delays in producing materials for our drug products and product candidates if they are required, under the U.S. Defense Production Act or similar governmental mandates, to prioritize production of raw materials, supplies, drugs or vaccines to address COVID-19.

- Any deterioration of worldwide credit and financial markets could result in losses on our holdings of cash and investments due to failures of financial institutions and other parties, and interruptions and delays in our ability to collect, or potential losses on, our accounts receivable.

The ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change.

However, these effects could have a material adverse impact on our business, results of operations, and financial condition.

We depend heavily on the success of our most advanced drug candidates.

We and our collaborators might not be able to commercialize any of our or their drug candidates successfully, and we may spend significant time and money attempting to do so.

We have invested significant resources in the development of our most advanced drug candidates.

We have a number of drug candidates in Phase III clinical trials as monotherapies or in combination with other drugs and drug candidates, including parsaclisib, pemigatinib, retifanlimab, ruxolitinib, ruxolitinib cream and tafasitamab.

Our ability to generate product revenues will depend on the successful development and eventual commercialization of our most advanced drug candidates.

For example, in January 2016, a Phase II trial that was evaluating ruxolitinib in combination with regorafenib in patients with relapsed or refractory metastatic colorectal cancer and high C-reactive protein was stopped early after a planned analysis of interim efficacy data determined that the likelihood of the trial meeting its efficacy endpoint was insufficient.

In addition, in February 2016, we made a decision to discontinue our JANUS 1 study, our JANUS 2 study, our other studies of ruxolitinib in colorectal, breast and lung cancer, and our study of INCB39110 in pancreatic cancer after a planned analysis of interim efficacy data of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

Also, in April 2018, we along with Merck announced that the ECHO-301 study had been stopped and we also significantly downsized the epacadostat development program and in January 2020 we stopped our Phase III trial of itacitinib for the treatment of acute graft-versus-host-disease.

The consequences of the COVID-19 pandemic, including the economic effect on government budgets in the United States and elsewhere, may accelerate any of the healthcare reform efforts described above or result in future reform efforts, any of which could have adverse effects on our business, including higher costs for us, lower reimbursement rates for our products and lower demand for our products.

additional opportunities to further develop and commercialize existing drug candidates in specific jurisdictions, such as our June 2016 acquisition of the development and commercialization rights to ICLUSIG in certain countries.

Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.

Physicians may not recommend our or our collaborators’ drug products until longer-term clinical data or other factors demonstrate the safety and efficacy of our or our collaborators’ drug products as compared to other alternative treatments.

Even if the clinical safety and efficacy of our or our collaborators’ drug products is established, physicians may elect not to prescribe these drug products for a variety of reasons, including the reimbursement policies of government and other third-party payors and the effectiveness of our or our collaborators’ competitors in marketing their products.

Market acceptance of our drug products, if approved for commercial sale, will depend on a number of factors, including the following, and market acceptance of our collaborators’ drug products will depend on similar factors:

A discussion of our financial performance for the year ended December 31, [removed: 2022] [added: 2023] as compared to the year ended December 31, [removed: 2021] [added: 2022] appears below under the captions “Results of Operations” and “Liquidity and Capital Resources.” A discussion of our financial performance for the year ended December 31, [removed: 2021] [added: 2022] compared to the year ended December 31, [removed: 2020] [added: 2021] can be found under the same captions in Item 7 of our Annual Report on Form 10-K for the year ended December 31, [removed: 2021,] [added: 2022,] filed with the SEC on February [removed: 8, 2022,] [added: 7, 2023,] which is available free of charge on the SEC’s website at *www.sec.gov* and our Investor Relations website at *investor.incyte.com/financial-information/annual-reports*.

Incyte is a [added: global] biopharmaceutical company [removed: focused on] [added: engaged in] the discovery, development and commercialization of proprietary therapeutics.

Our global headquarters is located in Wilmington, Delaware, where we conduct [removed: global] [added: discovery,] clinical development and commercial operations.

We also conduct clinical development and commercial operations from our European headquarters in Morges, Switzerland and our other offices across Europe, [added: as well as] our Japanese office in Tokyo and our Canadian headquarters in Montreal.

Our portfolio focuses on areas of high unmet medical need and includes compounds in various stages, ranging from preclinical to late stage development, and commercialized products [removed: JAKAFI®] [added: JAKAFI] (ruxolitinib), [removed: ICLUSIG®] [added: ICLUSIG] (ponatinib), [removed: PEMAZYRE®] [added: PEMAZYRE] (pemigatinib) and [removed: OPZELURA™] [added: OPZELURA] (ruxolitinib) cream, as well as [removed: MINJUVI®] [added: MINJUVI] (tafasitamab) and [removed: MONJUVI®] [added: MONJUVI] (tafasitamab-cxix), which [removed: are co-commercialized.][added: prior to our February 2024 acquisition of global rights to tafasitamab, were co-commercialized, and ZYNYZ (retifanlimab-dlwr).]

Our product revenues consist of sales of JAKAFI, OPZELURA, [removed: PEMAZYRE,] ICLUSIG, [added: PEMAZYRE, MINJUVI,] and [removed: MINJUVI.][added: ZYNYZ.]

We recognize revenues for product received by our customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates, such as [added: the Medicaid Drug Rebate Program and] Medicare Part D coverage gap reimbursements in the United States.

As of December 31, [removed: 2022,] [added: 2023,] a 5% change in our sales allowance and accruals would have had an approximate [removed: $50.1] [added: $64.3] million impact on our income before taxes.

For the years ending December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] our Black-Scholes assumptions included a weighted-average stock price volatility of [removed: 36%] [added: 32%] in [removed: 2022] [added: 2023] and [removed: 39%] [added: 36%] in [removed: 2021,] [added: 2022,] average expected option life of approximately five years and an estimated annualized forfeiture rate of 5%.

The average risk-free interest rate assumption used in the Black-Scholes valuations increased from [removed: 0.62%] [added: 2.14%] in [removed: 2021] [added: 2022] to [removed: 2.14%] [added: 4.01%] in [removed: 2022.][added: 2023.]

Years Ended December 31, [removed: 2022] [added: 2023] and [removed: 2021][added: 2022]

We recorded net income for the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] of [removed: $340.7] [added: $597.6] million and [removed: $948.6] [added: $340.7] million, respectively.

On a per share basis, basic net income was [removed: $4.30] [added: $2.67] and diluted net income was [removed: $4.27] [added: $2.65] for the year ended December 31, [removed: 2021.][added: 2023.]

| JAKAFI revenues, net | | | $ | [removed: 2,409.2] [added: 2,593.7] | | | | | $ | [removed: 2,134.5] [added: 2,409.2] | |

| ICLUSIG revenues, net | | | [removed: 105.8] [added: 111.6] | | | | | | [removed: 109.4] [added: 105.8] | | |

| PEMAZYRE revenues, net | | | [removed: 83.5] [added: 83.6] | | | | | | [removed: 68.5] [added: 83.5] | | |

| MINJUVI revenues, net | | | [removed: 19.7] [added: 37.1] | | | | | | [removed: 4.9] [added: 19.7] | | |

| OPZELURA revenues, net | | | [removed: 128.7] [added: 337.9] | | | | | | [removed: 4.7] [added: 128.7] | | |

| Total product revenues, net | | | [removed: 2,746.9] [added: 3,165.2] | | | | | | [removed: 2,322.0] [added: 2,746.9] | | |

| JAKAVI product royalty revenues | | | [removed: 331.6] [added: 367.6] | | | | | | [removed: 338.0] [added: 331.6] | | |

| OLUMIANT product royalty revenues | | | [removed: 134.5] [added: 136.1] | | | | | | [removed: 220.9] [added: 134.5] | | |

| TABRECTA product royalty revenues | | | [removed: 15.4] [added: 17.8] | | | | | | [removed: 10.4] [added: 15.4] | | |

| PEMAZYRE product royalty revenues | | | [removed: 1.2] [added: 1.9] | | | | | | [removed: —] [added: 1.2] | | |

| Total product royalty revenues | | | [removed: 482.7] [added: 523.4] | | | | | | [removed: 569.3] [added: 482.7] | | |

| Milestone and contract revenues | | | [removed: 165.0] [added: 7.0] | | | | | | [removed: 95.0] [added: 165.0] | | |

| Total revenues | | | $ | [removed: 3,394.6] [added: 3,695.6] | | | | | $ | [removed: 2,986.3] [added: 3,394.6] | |

The increase in JAKAFI product revenues from [removed: 2021 to] 2022 [added: to 2023] was comprised of a volume increase of [removed: $156.5] [added: $135.3] million and a price increase of [removed: $118.2] [added: $49.2] million.

| Year Ended December 31, [removed: 2022] [added: 2023] | | | | | | Discounts and Distribution Fees | | | | | | Government Rebates and Chargebacks | | | | | | Co-Pay Assistance and Other Discounts | | | | | | Product Returns | | | | | | Total | | |

| Allowances for prior period sales | | | | | | [removed: (94)] [added: (729)] | | | | | | [removed: (2,626)] [added: 5,338] | | | | | | [removed: (5)] [added: 3,314] | | | | | | [removed: —] [added: 3,033] | | | | | | [removed: (2,725)] [added: 10,956] | | |

| Balance at [removed: December 31, 2022] [added: January 1, 2023] | | | | | | $ | 25,316 | | | | | $ | 148,465 | | | | | $ | 25,580 | | | | | $ | 6,366 | | | | | $ | 205,727 | |

The [removed: decrease] [added: increase] in [removed: JAKAVI] [added: OLUMIANT] product royalty revenues for the year ended December 31, [removed: 2022] [added: 2023] as compared to the corresponding period in [removed: 2021 reflects] [added: 2022 includes] unfavorable changes in foreign currency exchange rates.

Our milestone and contract revenues were [removed: $165.0] [added: $7.0] million and [removed: $95.0] [added: $165.0] million for the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] respectively.

| Product costs | | | $ | [removed: 57.1] [added: 89.2] | | | | | $ | [removed: 21.0] [added: 57.1] | |

| Salary and benefits related | | | [removed: 9.5] [added: 11.9] | | | | | | [removed: 7.2] [added: 9.5] | | |

| Stock compensation | | | [removed: 2.7] [added: 3.1] | | | | | | [removed: 1.7] [added: 2.7] | | |

| Royalty expense | | | [removed: 116.2] [added: 128.2] | | | | | | [removed: 99.6] [added: 116.2] | | |

| Amortization of definite-lived intangible assets | | | [removed: 21.5] [added: 22.6] | | | | | | 21.5 | | |

| Total cost of product revenues | | | $ | [removed: 207.0] [added: 255.0] | | | | | $ | [removed: 151.0] [added: 207.0] | |

Cost of product revenues includes all product related costs, [added: reserves for obsolescence,] employee personnel costs, including stock compensation, for those employees dedicated to the production of our commercial products, royalties owed under our collaborative agreements and amortization of our licensed intellectual property rights for ICLUSIG [removed: using the straight-line method over] [added: and] the [removed: estimated useful life] [added: amortization] of [removed: 12.5 years.][added: capitalized milestone payments.]

| Salary and benefits related | | | $ | [removed: 345.6] [added: 399.1] | | | | | $ | [removed: 306.0] [added: 345.6] | |

We are focused in two therapeutic areas that are defined by the indications of our approved medicines and the diseases for which our clinical candidates are being developed.

One therapeutic area is Hematology/Oncology, which comprises Myeloproliferative Neoplasms (MPNs), Graft-Versus-Host Disease (GVHD), solid tumors and hematologic malignancies.

The other therapeutic area is Inflammation and Autoimmunity (IAI), which includes our Dermatology commercial franchise.

We are also eligible to receive milestones and royalties on molecules discovered by us and licensed to third parties.

In March 2023, under our collaboration agreement with MacroGenics, we received FDA approval of ZYNYZ for the treatment of adults with Merkel cell carcinoma.

In April 2023, the European Commission granted a marketing authorization for OPZELURA(ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

In September 2023, under our collaboration agreement with Novartis, we received the regulatory approval of JAKAVI (ruxolitinib) in GVHD by the Japanese Ministry of Health, Labour and Welfare.

In December 2023, the BLA was submitted for axatilimab in chronic graft-versus-host disease for the treatment of patients with chronic GVHD after failure of two or more lines of systemic therapy.

| | | | 2023 | | | | | | 2022 | | |

| ZYNYZ revenues, net | | | 1.3 | | | | | | — | | |

The increase in OPZELURA net product revenues from 2022 to 2023 was driven by growth in patient demand, refills and expansion in payer coverage as the launch in atopic dermatitis and vitiligo continues.

Product revenues are recorded net of sales allowances.

| Allowances for current period sales | | | | | | 132,062 | | | | | | 994,597 | | | | | | 136,745 | | | | | | 11,986 | | | | | | 1,275,390 | | |

| Credits/payments for current period sales | | | | | | (114,055) | | | | | | (811,357) | | | | | | (135,550) | | | | | | — | | | | | | (1,060,962) | | |

| Credits/payments for prior period sales | | | | | | (22,115) | | | | | | (95,108) | | | | | | (17,073) | | | | | | (10,364) | | | | | | (144,660) | | |

| Balance at December 31, 2023 | | | | | | $ | 20,479 | | | | | $ | 241,935 | | | | | $ | 13,016 | | | | | $ | 11,021 | | | | | $ | 286,451 | |

We brought a lawsuit against the U.S. Centers for Medicare and Medicaid Services (“CMS”) alleging that a recent regulation issued by CMS on the definition of “line extension” for purposes of the Medicaid rebate program is too broad and has the unintended consequence of treating OPZELURA as a “line extension” of JAKAFI under this program.

We believe that such a reading would violate CMS's statutory authority and be arbitrary and capricious, given that OPZELURA, among other differentiators, is indicated to treat entirely different medical conditions and entirely different patient populations than JAKAFI.

As of December 31, 2023, we have accrued approximately $59.5 million within accrued and other current liabilities on the consolidated balance sheet, relating to the incremental rebates that would be owed were OPZELURA considered a line extension of JAKAFI.

The impact on OPZELURA gross to net deductions for the quarter ending December 31, 2023, is approximately 6.5%.

If OPZELURA is not treated as a line extension of JAKAFI, this would result in a reversal of our accrual and a lower future gross to net deduction for OPZELURA.

During the year ended December 31, 2023, our milestone and contract revenues were primarily derived from a regulatory milestone under the Novartis collaboration and license agreement.

| | | | 2023 | | | | | | 2022 | | |

Cost of product revenues increased from 2022 to 2023 due primarily to growth in net product revenues and inventory reserves for obsolescence.

| | | | 2023 | | | | | | 2022 | | |

The decrease in clinical research and outside services expense from 2022 to 2023 was primarily due to a decrease in one-time collaboration related expenses.

| | | | 2023 | | | | | | 2022 | | |

In February 2024, we entered into a purchase agreement with MorphoSys, as a result of which we now hold exclusive global rights for tafasitamab.

See Note 18 of Notes to the Consolidated Financial Statements for further information relating to this agreement.

The increase in interest income and other, net primarily relates to an increase in interest earned on our cash equivalents and marketable securities generally due to higher interest rates.

| | | | 2023 | | | | | | 2022 | | |

Our effective tax rate of 28.4% for the year ended December 31, 2023 decreased as compared to 35.6% for the prior year period primarily due to the dilution of the rate impact of foreign losses with no associated tax benefit, an increase in the tax rate benefits associated with research and development and orphan drug tax credits and a decrease in certain non-deductible expenses.

Our effective tax rates for 2023 and 2022 were higher than the U.S. statutory rate primarily due to foreign losses with no associated tax benefit (i.e., full valuation allowance) and an increase in our valuation allowance against certain U.S. federal and state deferred tax assets.

This was partially offset by tax rate benefits associated with research and development and orphan drug tax credit generations and the foreign derived intangible income deduction.

| | | | | | | | | | | | |

| | | | 2023 | | | | | | 2022 | | |

The amendment to the credit facility is discussed further in Note 16 of Notes to the Consolidated Financial Statements.

Effects of the COVID-19 Pandemic on Our Business

The impact of the COVID-19 pandemic on our operational and financial performance going forward depends on numerous factors, all of which are difficult to predict.

These include the duration, spread and intensity of the pandemic; the protective measures imposed (or reimposed) by governmental authorities or by us to protect our employees; and the effects of the pandemic and such protective measures on our suppliers, collaborators and services providers and on the healthcare organizations serving patients.

As a result, it is not currently possible to ascertain the potential long term impact of the COVID-19 pandemic on our business.

To date, however, we have not experienced a material effect on the results of our commercial operations, or our manufacturing supply chain.

New patient starts for treatment decreased as a result of shelter in place and other protective measures in the early stages of the pandemic, and if decreases in new patient starts occur in future periods, our revenues in future periods could be adversely affected.

We continue to anticipate that short-term effects may continue to emerge across different aspects of our global clinical trial programs.

For example, while we expect ongoing monitoring of already-enrolled patients to continue, difficulties in monitoring may result as a consequence of any new shelter in place orders and other protective measures implemented by governmental authorities or clinical trial sites.

In addition, new patient recruitment in certain clinical trials has been and may in the future be impacted, in particular with respect to our earlier stage clinical trials.

We also expect the conduct of clinical trials may continue to vary by disease state and by severity of disease, as well as by geography, as some regions are more adversely impacted.

Overall, we caution that the duration and severity of the continuing COVID-19 pandemic remains uncertain, and we may not yet be able to assess its consequences accurately or fully at this time.

In May 2022, under our collaboration agreement with Novartis International Pharmaceutical Ltd., the European Commission (EC) approved JAKAVI (ruxolitinib) for the treatment of patients aged 12 years and older with acute and chronic GVHD and who have inadequate response to corticosteroids or other systemic therapies.

JAKAVI is the first Janus kinase (JAK)1/2 inhibitor available for patients with GVHD in Europe.

In May 2022, under our collaboration agreement with Eli Lilly and Company, the U.S. Food and Drug Administration (FDA) approved OLUMIANT for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first.

OLUMIANT is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.

In June 2022, under our collaboration agreement with Novartis, the EC approved TABRECTA (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer NSCLC) harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) kipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

In June 2022, under our collaboration agreement with Lilly, the FDA approved OLUMIANT as the first and only systemic treatment for adults with severe alopecia areata (AA).

In June 2022, the EC approved OLUMIANT as the first and only centrally-authorized treatment for adults with severe AA in Europe.

In June 2022, the Japan Ministry of Health, Labor and Welfare approved OLUMIANT as a treatment for adults with alopecia areata.

In July 2022, the FDA approved OPZELURA (ruxolitinib) cream for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

OPZELURA is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a JAK inhibitor approved in the United States.

In August 2022, the FDA approved PEMAZYRE for the treatment of adults with relapsed or refractory myeloid/ lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

PEMAZYRE is the first and only targeted treatment for MLNs with FGFR1 rearrangement.

MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers that may impact less than 1 in 100,000 people in the United States.

In December 2022, the FDA approved a supplemental new drug application (sNDA) for revisions to JAKAFI labelling to update the Pediatric Use section of the Prescribing Information to describe the available experience of ruxolitinib in pediatric patients based on data from a study in children with de novo high-risk CRLF2-rearranged and/or JAK pathway-mutant acute lymphoblastic leukemia.

Summarized below are the significant achievements under our existing collaboration and license agreements and additional agreements we entered into during the year ended December 31, 2022.

Innovent

In March 2022, we recognized a $5.0 million milestone under our collaboration and licensing agreement with Innovent Biologics, Inc., for approval for PEMAZYRE in China for the treatment of adults with locally advanced or metastatic cholangiocarcinoma, which was recorded in milestone and contract revenues.

Lilly

In June 2022, we recognized $70.0 million in regulatory milestones for Eli Lilly and Company gaining approval of OLUMIANT in the United States, Europe and Japan for the treatment of alopecia areata.

Maruho

In April 2022, we entered into a Strategic Alliance Agreement with Maruho Co., Ltd for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan.

Under the terms of the agreement, we recognized an upfront payment and are eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product in Japan.

Maruho will receive the rights to develop, manufacture and exclusively commercialize ruxolitinib cream, and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, in Japan.

Novartis

In April 2022, we recognized a $15.0 million regulatory milestone for the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) that recommended granting marketing authorization for capmatinib (TABRECTA) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer.

Additionally, in May 2022, we recognized a $45.0 million regulatory milestone as a result of the European Commission’s approval of JAKAVI (ruxolitinib) as the first post-steroid treatment for acute and chronic GVHD.

Villaris

In November 2022, we acquired Villaris Therapeutics, Inc., an asset-centric biopharmaceutical company focused on the development of novel antibody therapeutics for vitiligo.

Its lead asset, auremolimab (VM6), is an anti-IL-15Rβ monoclonal antibody (mAb).

As of December 31, [removed: 2022,] [added: 2023,] marketable securities were [removed: $287.5] [added: $442.7] million.

Due to the nature of these investments, if market interest rates were to increase immediately and uniformly by 10% from levels as of December 31, [removed: 2022,] [added: 2023,] the decline in fair value would not be material.

Incyte is a [added: global] biopharmaceutical company [removed: focused on] [added: engaged in] the discovery, development and commercialization of proprietary therapeutics.

Our global headquarters is located in Wilmington, Delaware, where we conduct [removed: global] [added: discovery,] clinical development and commercial operations.

[removed: As described in more detail below, we operate] [added: We are focused] in two therapeutic areas that are defined by the indications of our approved medicines and the diseases for which our clinical candidates are being developed.

One therapeutic area is Hematology/Oncology, which comprises Myeloproliferative Neoplasms (MPNs), Graft-Versus-Host Disease (GVHD), [removed: and] solid tumors and hematologic malignancies.

Our hematology and oncology franchise comprises [removed: four] [added: five] approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE [removed: (pemigatinib) and] [added: (pemigatinib),] ICLUSIG [removed: (ponatinib),] [added: (ponatinib) and ZYNYZ (retifanlimab-dlwr),] as well as numerous clinical development programs.

The FDA approval was based on results from two randomized Phase [removed: III] [added: 3] trials (COMFORT-I and COMFORT-II), which demonstrated that patients treated with JAKAFI experienced significant reductions in splenomegaly (enlarged spleen).

The approval of JAKAFI for PV was based on data from the pivotal Phase [removed: III] [added: 3] RESPONSE trial.

In June 2016, we announced data from the Phase [removed: III] [added: 3] RESPONSE-2 study of JAKAFI in patients with inadequately controlled PV that was resistant to or intolerant of hydroxyurea who did not have an enlarged spleen.

This approval was based on data from REACH3, a Phase [removed: III,] [added: 3,] randomized, open-label, multicenter study of JAKAFI in comparison to best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation.

We hold patents that cover the composition of matter and use of [removed: ruxolitinib.][added: ruxolitinib and its salt.]

These patents, including applicable extensions, currently expire in [removed: late-2028.][added: mid and late 2028.]

[removed: We have been] [added: In December 2022, we were] granted pediatric [removed: exclusivity] [added: exclusivity,] which adds six months to the expiration for all ruxolitinib patents [removed: presently] listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange [removed: Book).][added: Book) as of the date of the grant of pediatric exclusivity.]

[removed: We have] [added: Under the terms of the collaboration and license agreement, we received] rights to co-commercialize tafasitamab in the United States with MorphoSys, and [removed: we have] exclusive development and commercialization rights outside of the United States.

In July 2020, we and MorphoSys announced that the FDA [added: had] approved MONJUVI (tafasitamab-cxix), which is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

MONJUVI was approved under accelerated approval based on overall response rate from the MorphoSys-sponsored Phase [removed: II] [added: 2] L-MIND study, an open label, multicenter, single arm trial of MONJUVI in combination with lenalidomide as a treatment for adult patients with r/r DLBCL.

In August 2021, we and MorphoSys announced that the European Commission [removed: (EC)] [added: had] granted conditional marketing authorization for MINJUVI (tafasitamab) in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).

In April 2020, we announced that the FDA [added: had] approved PEMAZYRE (pemigatinib), a selective fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

Also in March 2021, PEMAZYRE was approved by the European Commission [removed: (EC)] for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that [removed: have] [added: has] progressed after at least one prior line of systemic therapy.

FIGHT-302, a Phase [removed: III] [added: 3] trial of pemigatinib for the first-line treatment of patients with cholangiocarcinoma and FGFR2 fusions or rearrangements, is ongoing.

In March 2022, PEMAZYRE was approved by the National Medical Products Administration (NMPA) of the People’s Republic of China for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that [removed: have] [added: has] progressed after at least one prior line of systemic therapy.

In June 2016, we acquired the European operations of ARIAD Pharmaceuticals, [removed: Inc.] [added: Inc.,] and obtained an exclusive license to develop and commercialize ICLUSIG (ponatinib) in Europe and other select countries.

[removed: As part of our ongoing LIMBER (Leadership In MPNs BEyond Ruxolitinib) clinical development initiative, which is designed to improve and expand therapeutic options for patients with myeloproliferative neoplasms, we] [added: We] are evaluating combinations of ruxolitinib with other therapeutic modalities, as well as developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and combination therapy.

Bioavailability and bioequivalence data were published for ruxolitinib’s once-daily (QD) extended release (XR) formulation at the European Hematology Association (EHA) [removed: 2021] Virtual Congress in June 2021.

Together, we plan to develop axatilimab as a therapy for patients with chronic GVHD [removed: as well as in additional immune-mediated diseases] where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.

In December 2021, updated positive data were presented at ASH from the Phase [removed: I/II] [added: 1/2] trial evaluating axatilimab as a monotherapy in patients with recurrent or refractory chronic GVHD after two or more prior lines of therapy.

In May 2022, Syndax announced that axatilimab [removed: was] [added: had been] granted fast-track designation by the FDA for the treatment of patients with chronic GVHD after failure of two or more lines of systemic therapy.

An open-label Phase [removed: II] [added: 2] combination trial (L-MIND) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and the ongoing Phase [removed: III] [added: 3] B-MIND trial is assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL.

firstMIND is a Phase [removed: Ib] [added: 1b] safety trial of tafasitamab as a first-line therapy for patients with DLBCL, and frontMIND, a placebo-controlled Phase [removed: III] [added: 3] trial evaluating tafasitamab in combination with lenalidomide added to rituximab plus chemotherapy (R-CHOP) as a first-line therapy for patients with DLBCL, is ongoing.

A placebo-controlled Phase [removed: III] [added: 3] trial (inMIND) of tafasitamab added to lenalidomide plus rituximab (R2) in patients with relapsed or refractory follicular or marginal zone lymphomas is ongoing.

The program initially included three Phase [removed: II] [added: 2] trials – FIGHT-201 in patients with bladder cancer, FIGHT-202 in patients with cholangiocarcinoma, and FIGHT-203 in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement.

Based on data generated from these trials, we have initiated additional trials including FIGHT-302, a Phase [removed: III] [added: 3] study in first-line cholangiocarcinoma.

Based on findings from this study, we have identified populations that [removed: may] potentially [added: may] benefit from treatment with [removed: pemigatinib] [added: pemigatinib,] and [removed: have initiated two] [added: a] Phase [removed: II trials – FIGHT-209] [added: 2 trial, FIGHT-209,] in patients with glioblastoma [removed: and FIGHT-210 in patients with non-small cell lung cancer.][added: is ongoing.]

The FDA [added: has] granted [removed: orphan drug designation and] Fast Track designation [added: and orphan drug designation] to [removed: parsaclisib] [added: zilurgisertib] as a treatment for patients with [removed: follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.][added: FOP.]

In October 2017, we and MacroGenics, [removed: Inc.] [added: Inc.,] announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), an investigational monoclonal antibody that inhibits PD-1.

The molecule [removed: is] currently [added: is] being evaluated both as monotherapy and in combination therapy across various tumor types.

The Phase [removed: III] [added: 3] POD1UM-303 trial of retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with squamous cell carcinoma of the anal canal (SCAC) is [removed: underway.][added: ongoing.]

The Phase [removed: III] [added: 3] POD1UM-304 trial is evaluating retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with non-small cell lung cancer (NSCLC).

In November 2021, we highlighted Phase [removed: I] [added: 1] clinical safety and efficacy data for our oral PD-L1 program which included two compounds, INCB99280 and INCB99318.

We plan to evaluate INCB99280 in Phase [removed: II] [added: 2] as monotherapy and in combination with other antitumor agents.

| [removed: ruxolitinib] [added: Ruxolitinib] XR (QD) (JAK1/JAK2) | | | Myelofibrosis, polycythemia vera and [removed: GVHD: NDA under review] [added: GVHD] | | | [added: | | |]

In September 2023, we were notified by the Centers for Medicare and Medicaid Services (CMS) that ruxolitinib phosphate qualified for the Small Biotech Exception.

As more fully described in Note 18 of Notes to the Consolidated Financial Statements, in February 2024, we entered into a purchase agreement with MorphoSys, the result of which we now hold exclusive global rights for tafasitamab, and the collaboration and license agreement was terminated.

Updated three-year data from L-MIND were presented at the American Society of Clinical Oncology (ASCO) 2021 and final five-year data were presented at the American Association for Cancer Research (AACR) 2023, which showed that the MONJUVI plus lenalidomide regimen followed by MONJUVI monotherapy provided prolonged, durable responses in adult patients with r/r DLBCL.

In March 2023, PEMAZYRE was approved by the MHLW for the treatment of MLNs with FGFR1 fusion.

ZYNYZ (retifanlimab-dlwr)

Two Phase 3 trials evaluating retifanlimab in squamous cell anal cancer (SCAC) and non-small cell lung cancer (NSCLC) are ongoing.

In March 2023, we announced that the FDA had approved ZYNYZ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), under accelerated approval, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

This represents the first regulatory approval for our PD-1 inhibitor.

In March 2023, the FDA issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD.

In December 2023, we received FDA feedback and agreed on the requirements to address the complete response letter.

Phase 2 trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) and INCB00928 (Zilurgisertib) in patients with MF are ongoing, and updated data demonstrating early signals of clinical activity of both agents in monotherapy and in combination with ruxolitinib were presented in June 2023 at the American Society of Clinical Oncology (ASCO) annual meeting and in December 2023 at the American Society of Hematology (ASH) meeting.

Additional discovery and development initiatives are also ongoing, advancing two Phase 1 studies with INCA33989 (mCALR) and INCB160058 (JAK2V617Fi), both of which hold the potential to be disease modifying therapeutics and address significant unmet need in MF, PV and ET.

In July 2023, we and Syndax announced that AGAVE-201 had met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at the dose of 0.3 mg/kg administered every two weeks.

The data highlight the durable response seen at the 0.3 mg/kg dose with 60% of patients who responded to axatilimab still responding at one year.

In December 2023, a Biologics License Application (BLA) was submitted to the FDA for axatilimab for the treatment of patients with chronic GVHD after failure of two or more lines of systemic therapy.

Plans are underway to initiate two combination trials with axatilimab in cGVHD in mid-2024, including a randomized Phase 2 combination trial with ruxolitinib and a randomized Phase 3 combination trial with steroids, both directed at treating patients with cGVHD in earlier lines of therapy.

INCA033989 (mCALR)

In July 2023, a Phase 1 study evaluating INCA033989 was initiated.

INCB160058 (JAK2V617Fi)

In December 2023, new research detailing the development and mechanism of action of INCB160058, an Incyte-discovered, investigational novel potent and selective JAK2 pseudokinase domain binder with potential to be a disease modifying therapeutic was disclosed at the 65th American Society of Hematology (ASH) Annual Meeting.

Pseudokinase binding offers a new mechanism of action for selective inhibition of JAK2V617F, with potential to eradicate mutant clones.

In preclinical studies, INCB160058 inhibited cytokine independent activity of JAK2V617F while sparing WT JAK2.

The JAK2V617F mutation is found in 55% of primary myelofibrosis, 95% of polycythemia vera and 60% of essential thrombocythemia patients.

We currently plan to initiate a Phase 1 study of INCB160058 in the second quarter of 2024.

In July 2023, we initiated two Phase 1 studies evaluating INCB99280 in combination with axitinib (VEGF) and in combination with ipilimumab (CTLA-4).

A Phase 2 study evaluating INCB99280 in patients with select solid tumors who are checkpoint inhibitor naive also was initiated.

Additionally, we initiated a Phase 2 study evaluating INCB99280 in metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC.

We and Replimune Group, Inc. announced a clinical trial collaboration and supply agreement to investigate the combination of INCB99280 and RP1 in patients with cutaneous squamous cell carcinoma.

RP1 is Replimune’s lead oncolytic immunotherapy product candidate and is based on a proprietary new strain of herpes simplex virus engineered for robust tumor selective replication and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| MPN, GVHD and Oncology Programs | | | Indication and Phase | | | | | |

| INCA033989 (mCALR) | | | Myelofibrosis, essential thrombocythemia: Phase 1 | | | | | |

| INCB160058 (JAK2V617Fi) | | | Phase 1 | | | | | |

| Tafasitamab (MONJUVI/MINJUVI) (CD19) | | | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (*front*MIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (*in*MIND) | | | | | |

| INCB99280 (Oral PD-L1) | | | Solid tumors (combination): Phase 1 Solid tumors (monotherapy): Phase 2 Cutaneous squamous cell carcinoma (cSCC): Phase 2 | | | | | |

| INCB123667 (CDK2i) | | | Solid tumors with Amplification/ Overexpression of CCNE1: Phase 1 | | | | | |

| INCB161734 (KRASG12D) | | | Advanced metastatic solid tumors with a KRAS G12D mutation: Phase 1 | | | | | |

2.Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.

In April 2023, we presented data at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating that INCB123667 exhibited significant single-agent activity in vivo, in CCNE1 high breast cancer xenograft and patient-derived xenograft models.

The agreement became effective March 2020.

Updated three-year data from L-MIND were presented at the American Society of Clinical Oncology (ASCO) 2021.

The FDA accepted the New Drug Application (NDA) for QD ruxolitinib with a Prescription Drug User Fee Act (PDUFA) target action date of March 23, 2023.

Based on positive Phase II data, we opened two pivotal trials of ruxolitinib in combination with parsaclisib (PI3Kδ) in first-line MF (LIMBER-313) and in MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304), and both trials are ongoing.

Additional Phase II trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) and INCB00928 (ALK2) in patients with MF are ongoing, and additional discovery and development initiatives are also ongoing within the LIMBER program, which are evaluating internally-discovered compounds, and candidates from collaboration partners.

Additional trials of axatilimab are planned in patients with chronic GVHD, including a Phase II trial in combination with ruxolitinib in patients with newly-diagnosed cGVHD.

A proof-of-concept study of tafasitamab, lenalidomide and plamotamab in patients with r/r DLBCL is also ongoing.

Parsaclisib

The PI3Kδ pathway mediates oncogenic signaling in B cell malignancies.

Parsaclisib is a PI3Kδ inhibitor that has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients with lymphoma.

We initiated the CITADEL clinical program to evaluate parsaclisib in non-Hodgkin lymphomas, including Phase II trials in follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.

In December 2020, we announced preliminary results from the ongoing CITADEL monotherapy development program, which was designed to enable registration of parsaclisib.

Results from four cohorts were presented at the American Society of Hematology (ASH), including in r/r follicular lymphoma (CITADEL-203), in BTK-naïve r/r marginal zone lymphoma (CITADEL-204) and in both BTK-naïve and BTK-experienced r/r mantle cell lymphoma (CITADEL-205).

In October 2021, we announced the FDA acceptance of an NDA seeking approval of parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.

The submission was based on data from several Phase II studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory non-Hodgkin lymphomas (follicular, marginal zone and mantle cell).

In January 2022, we announced that we withdrew the NDA seeking approval of parsaclisib for the three indications in non-Hodgkin lymphoma.

The decision to withdraw the NDA followed discussions with FDA regarding confirmatory studies that we determined cannot be completed within a reasonable time period to support an accelerated approval.

In July 2022, we withdrew the Marketing Authorization Application (MAA) seeking approval of parsaclisib in marginal zone lymphoma following discussions with the European Medicines Agency (EMA) regarding the confirmatory study needed to support the approval which we determined were not feasible.

Parsaclisib is being evaluated as a treatment for autoimmune hemolytic anemia (AIHA), a rare red blood cell disorder.

In June 2021, data from a Phase II trial were presented at EHA.

The majority of patients achieved a response with parsaclisib over the initial 12-week treatment period and treatment with parsaclisib was generally well tolerated.

Based on these results, we initiated a Phase III trial (PATHWAY) in warm AIHA.

The FDA has granted orphan drug designation to parsaclisib as a treatment for patients with AIHA.

Potentially registration-enabling trials in microsatellite instability-high (MSI-H) endometrial cancer and Merkel cell carcinoma are ongoing.

Retifanlimab has been granted Fast Track designation for the treatment of certain patients with advanced or metastatic MSI-H or DNA mismatch repair (dMMR) endometrial cancer, for the treatment of certain patients with locally advanced or metastatic SCAC and for the treatment of Merkel cell carcinoma (MCC).

The FDA and EMA have granted orphan drug designation to retifanlimab as a treatment for patients with locally advanced or metastatic SCAC and the FDA has granted orphan drug designation to retifanlimab as a treatment for patients with MCC.

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| | | | Indication and status | | |

| ruxolitinib + parsaclisib (JAK1/JAK2 + PI3Kδ) | | | Myelofibrosis: Phase III (first-line therapy) (LIMBER-313) Myelofibrosis: Phase III (suboptimal responders to ruxolitinib) (LIMBER-304) | | |

| tafasitamab (CD19)3 | | | r/r DLBCL: Phase II (L-MIND); Phase III (B-MIND) 1L DLBCL: Phase III (frontMIND) r/r follicular & marginal zone lymphomas: Phase III (inMIND) | | |

| parsaclisib (PI3Kδ) | | | Warm autoimmune hemolytic anemia: Phase III (PATHWAY) | | |

| INCB99280 (Oral PD-L1) | | | Solid tumors: Phase I KRASG12C-mutated solid tumors: Phase I/Ib in combination with adagrasib, in preparation | | |

3.tafasitamab development in collaboration with MorphoSys.

INCA33989 (mCALR)

INCA33989 is currently expected to enter clinical studies in 2023.

| Small molecules | | | INCB81776 (AXL/MER), INCB106385 (A2A/A2B), INCB123667 (CDK2) | | |

2.Development collaboration with Merus

In December 2022, we also initiated a Phase II trial evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa.

In March 2021, we initiated a Phase II trial evaluating povorcitinib in patients with vitiligo.

For the fiscal year ended December 31, [removed: 2022] [added: 2023] or

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 30, [removed: 2022)] [added: 2023)] was approximately [removed: $14.2] [added: $11.7] billion.

As of [removed: January 31, 2023] [added: February 6, 2024] there were [removed: 222,965,018] [added: 224,526,128] shares of Common Stock, $.001 par value per share, outstanding.

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 [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be held on June [removed: 14, 2023.][added: 12, 2024.]

| | | | [Forward-Looking [removed: Statements](#if009c8ccc24c44da8511b38de3b79441_10)] [added: Statements](#ife611127b0c9404b8cdc4fe0d4e43090_10)] | | | [removed: [2](#if009c8ccc24c44da8511b38de3b79441_10)] [added: [2](#ife611127b0c9404b8cdc4fe0d4e43090_10)] | | |

| | | | [Summary Risk [removed: Factors](#if009c8ccc24c44da8511b38de3b79441_13)] [added: Factors](#ife611127b0c9404b8cdc4fe0d4e43090_13)] | | | [removed: [5](#if009c8ccc24c44da8511b38de3b79441_13)] [added: [5](#ife611127b0c9404b8cdc4fe0d4e43090_13)] | | |

| [Item [removed: 1.](#if009c8ccc24c44da8511b38de3b79441_19)] [added: 1.](#ife611127b0c9404b8cdc4fe0d4e43090_19)] | | | [removed: [Business](#if009c8ccc24c44da8511b38de3b79441_19)] [added: [Business](#ife611127b0c9404b8cdc4fe0d4e43090_19)] | | | [removed: [7](#if009c8ccc24c44da8511b38de3b79441_19)] [added: [6](#ife611127b0c9404b8cdc4fe0d4e43090_19)] | | |

| [Item [removed: 1A.](#if009c8ccc24c44da8511b38de3b79441_22)] [added: 1A.](#ife611127b0c9404b8cdc4fe0d4e43090_49)] | | | [Risk [removed: Factors](#if009c8ccc24c44da8511b38de3b79441_22)] [added: Factors](#ife611127b0c9404b8cdc4fe0d4e43090_49)] | | | [removed: [35](#if009c8ccc24c44da8511b38de3b79441_22)] [added: [36](#ife611127b0c9404b8cdc4fe0d4e43090_49)] | | |

| [Item [removed: 1B.](#if009c8ccc24c44da8511b38de3b79441_25)] [added: 1B.](#ife611127b0c9404b8cdc4fe0d4e43090_52)] | | | [Unresolved Staff [removed: Comments](#if009c8ccc24c44da8511b38de3b79441_25)] [added: Comments](#ife611127b0c9404b8cdc4fe0d4e43090_52)] | | | [removed: [62](#if009c8ccc24c44da8511b38de3b79441_25)] [added: [62](#ife611127b0c9404b8cdc4fe0d4e43090_52)] | | |

| [Item [removed: 2.](#if009c8ccc24c44da8511b38de3b79441_28)] [added: 2.](#ife611127b0c9404b8cdc4fe0d4e43090_55)] | | | [removed: [Properties](#if009c8ccc24c44da8511b38de3b79441_28)] [added: [Properties](#ife611127b0c9404b8cdc4fe0d4e43090_55)] | | | [removed: [62](#if009c8ccc24c44da8511b38de3b79441_28)] [added: [63](#ife611127b0c9404b8cdc4fe0d4e43090_55)] | | |

| [Item [removed: 3.](#if009c8ccc24c44da8511b38de3b79441_31)] [added: 3.](#ife611127b0c9404b8cdc4fe0d4e43090_58)] | | | [Legal [removed: Proceedings](#if009c8ccc24c44da8511b38de3b79441_31)] [added: Proceedings](#ife611127b0c9404b8cdc4fe0d4e43090_58)] | | | [removed: [62](#if009c8ccc24c44da8511b38de3b79441_31)] [added: [64](#ife611127b0c9404b8cdc4fe0d4e43090_58)] | | |

| [Item [removed: 4.](#if009c8ccc24c44da8511b38de3b79441_34)] [added: 4.](#ife611127b0c9404b8cdc4fe0d4e43090_61)] | | | [Mine Safety [removed: Disclosures](#if009c8ccc24c44da8511b38de3b79441_34)] [added: Disclosures](#ife611127b0c9404b8cdc4fe0d4e43090_61)] | | | [removed: [63](#if009c8ccc24c44da8511b38de3b79441_34)] [added: [64](#ife611127b0c9404b8cdc4fe0d4e43090_61)] | | |

| | | | [Information about our Executive [removed: Officers](#if009c8ccc24c44da8511b38de3b79441_37)] [added: Officers](#ife611127b0c9404b8cdc4fe0d4e43090_64)] | | | [removed: [63](#if009c8ccc24c44da8511b38de3b79441_37)] [added: [64](#ife611127b0c9404b8cdc4fe0d4e43090_64)] | | |

| [Item [removed: 5.](#if009c8ccc24c44da8511b38de3b79441_43)] [added: 5.](#ife611127b0c9404b8cdc4fe0d4e43090_70)] | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#if009c8ccc24c44da8511b38de3b79441_43)] [added: Securities](#ife611127b0c9404b8cdc4fe0d4e43090_70)] | | | [removed: [65](#if009c8ccc24c44da8511b38de3b79441_43)] [added: [67](#ife611127b0c9404b8cdc4fe0d4e43090_70)] | | |

| [Item [removed: 6.](#if009c8ccc24c44da8511b38de3b79441_46)] [added: 6.](#ife611127b0c9404b8cdc4fe0d4e43090_73)] | | | [removed: \[[Reserved](#if009c8ccc24c44da8511b38de3b79441_46)\]] [added: \[[Reserved](#ife611127b0c9404b8cdc4fe0d4e43090_73)\]] | | | [removed: [65](#if009c8ccc24c44da8511b38de3b79441_46)] [added: [67](#ife611127b0c9404b8cdc4fe0d4e43090_73)] | | |

| [Item [removed: 7.](#if009c8ccc24c44da8511b38de3b79441_49)] [added: 7.](#ife611127b0c9404b8cdc4fe0d4e43090_76)] | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#if009c8ccc24c44da8511b38de3b79441_49)] [added: Operations](#ife611127b0c9404b8cdc4fe0d4e43090_76)] | | | [removed: [65](#if009c8ccc24c44da8511b38de3b79441_49)] [added: [67](#ife611127b0c9404b8cdc4fe0d4e43090_76)] | | |

| [Item [removed: 7A.](#if009c8ccc24c44da8511b38de3b79441_73)] [added: 7A.](#ife611127b0c9404b8cdc4fe0d4e43090_91)] | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#if009c8ccc24c44da8511b38de3b79441_73)] [added: Risk](#ife611127b0c9404b8cdc4fe0d4e43090_91)] | | | [removed: [77](#if009c8ccc24c44da8511b38de3b79441_73)] [added: [76](#ife611127b0c9404b8cdc4fe0d4e43090_91)] | | |

| [Item [removed: 8.](#if009c8ccc24c44da8511b38de3b79441_76)] [added: 8.](#ife611127b0c9404b8cdc4fe0d4e43090_94)] | | | [Financial Statements and Supplementary [removed: Data](#if009c8ccc24c44da8511b38de3b79441_76)] [added: Data](#ife611127b0c9404b8cdc4fe0d4e43090_94)] | | | [removed: [78](#if009c8ccc24c44da8511b38de3b79441_76)] [added: [77](#ife611127b0c9404b8cdc4fe0d4e43090_94)] | | |

| [Item [removed: 9.](#if009c8ccc24c44da8511b38de3b79441_157)] [added: 9.](#ife611127b0c9404b8cdc4fe0d4e43090_175)] | | | [Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#if009c8ccc24c44da8511b38de3b79441_157)] [added: Disclosure](#ife611127b0c9404b8cdc4fe0d4e43090_175)] | | | [removed: [117](#if009c8ccc24c44da8511b38de3b79441_157)] [added: [116](#ife611127b0c9404b8cdc4fe0d4e43090_175)] | | |

| [Item [removed: 9A.](#if009c8ccc24c44da8511b38de3b79441_160)] [added: 9A.](#ife611127b0c9404b8cdc4fe0d4e43090_178)] | | | [Controls and [removed: Procedures](#if009c8ccc24c44da8511b38de3b79441_160)] [added: Procedures](#ife611127b0c9404b8cdc4fe0d4e43090_178)] | | | [removed: [117](#if009c8ccc24c44da8511b38de3b79441_160)] [added: [116](#ife611127b0c9404b8cdc4fe0d4e43090_178)] | | |

| [Item [removed: 9B.](#if009c8ccc24c44da8511b38de3b79441_163)] [added: 9B.](#ife611127b0c9404b8cdc4fe0d4e43090_181)] | | | [Other [removed: Information](#if009c8ccc24c44da8511b38de3b79441_163)] [added: Information](#ife611127b0c9404b8cdc4fe0d4e43090_181)] | | | [removed: [120](#if009c8ccc24c44da8511b38de3b79441_163)] [added: [119](#ife611127b0c9404b8cdc4fe0d4e43090_181)] | | |

| [Item [removed: 10.](#if009c8ccc24c44da8511b38de3b79441_169)] [added: 10.](#ife611127b0c9404b8cdc4fe0d4e43090_187)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#if009c8ccc24c44da8511b38de3b79441_169)] [added: Governance](#ife611127b0c9404b8cdc4fe0d4e43090_187)] | | | [removed: [120](#if009c8ccc24c44da8511b38de3b79441_169)] [added: [119](#ife611127b0c9404b8cdc4fe0d4e43090_187)] | | |

| [Item [removed: 11.](#if009c8ccc24c44da8511b38de3b79441_172)] [added: 11.](#ife611127b0c9404b8cdc4fe0d4e43090_190)] | | | [Executive [removed: Compensation](#if009c8ccc24c44da8511b38de3b79441_172)] [added: Compensation](#ife611127b0c9404b8cdc4fe0d4e43090_190)] | | | [removed: [120](#if009c8ccc24c44da8511b38de3b79441_172)] [added: [119](#ife611127b0c9404b8cdc4fe0d4e43090_190)] | | |

| [Item [removed: 12.](#if009c8ccc24c44da8511b38de3b79441_175)] [added: 12.](#ife611127b0c9404b8cdc4fe0d4e43090_193)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#if009c8ccc24c44da8511b38de3b79441_175)] [added: Matters](#ife611127b0c9404b8cdc4fe0d4e43090_193)] | | | [removed: [120](#if009c8ccc24c44da8511b38de3b79441_175)] [added: [120](#ife611127b0c9404b8cdc4fe0d4e43090_193)] | | |

| [Item [removed: 13.](#if009c8ccc24c44da8511b38de3b79441_178)] [added: 13.](#ife611127b0c9404b8cdc4fe0d4e43090_196)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#if009c8ccc24c44da8511b38de3b79441_178)] [added: Independence](#ife611127b0c9404b8cdc4fe0d4e43090_196)] | | | [removed: [121](#if009c8ccc24c44da8511b38de3b79441_178)] [added: [120](#ife611127b0c9404b8cdc4fe0d4e43090_196)] | | |

| [Item [removed: 14.](#if009c8ccc24c44da8511b38de3b79441_181)] [added: 14.](#ife611127b0c9404b8cdc4fe0d4e43090_199)] | | | [Principal Accountant Fees and [removed: Services](#if009c8ccc24c44da8511b38de3b79441_181)] [added: Services](#ife611127b0c9404b8cdc4fe0d4e43090_199)] | | | [removed: [121](#if009c8ccc24c44da8511b38de3b79441_181)] [added: [120](#ife611127b0c9404b8cdc4fe0d4e43090_199)] | | |

| [PART [removed: IV](#if009c8ccc24c44da8511b38de3b79441_184)] [added: III](#ife611127b0c9404b8cdc4fe0d4e43090_184)] | | | | | | | | |

| [Item [removed: 15.](#if009c8ccc24c44da8511b38de3b79441_187)] [added: 15.](#ife611127b0c9404b8cdc4fe0d4e43090_205)] | | | [Exhibits, Financial Statement [removed: Schedules](#if009c8ccc24c44da8511b38de3b79441_187)] [added: Schedules](#ife611127b0c9404b8cdc4fe0d4e43090_205)] | | | [removed: [121](#if009c8ccc24c44da8511b38de3b79441_187)] [added: [120](#ife611127b0c9404b8cdc4fe0d4e43090_205)] | | |

| [Item [removed: 16.](#if009c8ccc24c44da8511b38de3b79441_190)] [added: 16.](#ife611127b0c9404b8cdc4fe0d4e43090_208)] | | | [Form 10-K [removed: Summary](#if009c8ccc24c44da8511b38de3b79441_190)] [added: Summary](#ife611127b0c9404b8cdc4fe0d4e43090_208)] | | | [removed: [124](#if009c8ccc24c44da8511b38de3b79441_190)] [added: [123](#ife611127b0c9404b8cdc4fe0d4e43090_208)] | | |

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

- *our investments, including anticipated expenditures, losses and [removed: expenses;*][added: expenses; and*]

- *our patent prosecution and maintenance [removed: efforts; and*][added: efforts.*]

*Incyte, [removed: JAKAFI and] [added: JAKAFI, MINJUVI, MONJUVI, OPZELURA,] PEMAZYRE [added: and ZYNYZ] are our registered [removed: trademarks and OPZELURA is our trademark.][added: trademarks.]

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

| [PART I](#ife611127b0c9404b8cdc4fe0d4e43090_16) | | | | | | | | |

| [Item 1C.](#ife611127b0c9404b8cdc4fe0d4e43090_642) | | | [Cybersecurity](#ife611127b0c9404b8cdc4fe0d4e43090_642) | | | [63](#ife611127b0c9404b8cdc4fe0d4e43090_642) | | |

| [PART II](#ife611127b0c9404b8cdc4fe0d4e43090_67) | | | | | | | | |

| [Item 9C.](#ife611127b0c9404b8cdc4fe0d4e43090_649) | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#ife611127b0c9404b8cdc4fe0d4e43090_649) | | | [119](#ife611127b0c9404b8cdc4fe0d4e43090_649) | | |

| [PART IV](#ife611127b0c9404b8cdc4fe0d4e43090_202) | | | | | | | | |

| [SIGNATURES](#ife611127b0c9404b8cdc4fe0d4e43090_211) | | | | | | [123](#ife611127b0c9404b8cdc4fe0d4e43090_211) | | |

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

| [PART I](#if009c8ccc24c44da8511b38de3b79441_16) | | | | | | | | |

| [PART II](#if009c8ccc24c44da8511b38de3b79441_40) | | | | | | | | |

| [PART III](#if009c8ccc24c44da8511b38de3b79441_166) | | | | | | | | |

| [SIGNATURES](#if009c8ccc24c44da8511b38de3b79441_193) | | | | | | [124](#if009c8ccc24c44da8511b38de3b79441_193) | | |

- *the potential effects of the COVID-19 pandemic and efforts undertaken or to be undertaken by us or applicable governmental authorities on local and global economic conditions, and on our business, results of operations and financial condition.*

- The COVID-19 pandemic and measures to address the pandemic, as well as other geopolitical events, have adversely affected and could in the future adversely affect our business and results of operations.

- Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.

- We face significant competition for our drug discovery and development efforts, and if we do not compete effectively, our commercial opportunities will be reduced or eliminated.

Incyte is committed to maintaining robust oversight and governance of potential cybersecurity risks and to implementing processes and controls that help us identify, assess and manage such risks.

To date, we have not experienced a cybersecurity threat or incident that has resulted in a material adverse impact to our business or operations.

However, we cannot guarantee that we will not experience such a threat or incident in the future, given the increasing sophistication of those responsible for cybersecurity incidents.

While we seek to detect and investigate unauthorized attempts and attacks against our network and to prevent their occurrence where practicable through our internal processes and tools, we remain potentially vulnerable to known or unknown threats.

In some instances, we can be unaware of a threat or incident or its magnitude and effects.

Further, there is increasing regulation regarding responses to cybersecurity incidents, including reporting to regulators, which could subject us to additional liability and reputational harm.

See "Item 1A.

Risk Factors" for more information on our cybersecurity risks.

We aim to incorporate and align with industry best practices throughout our cybersecurity program.

Our cybersecurity strategy focuses on implementing effective and efficient controls, technologies and other processes to assess, identify, manage and mitigate material cybersecurity risks.

These include, among other things, having mechanisms in place to detect and monitor unusual network activity, utilizing vulnerability assessment scans and tools, and conducting external and internal penetration tests and security assessments using the National Institute of Standards and Technology (NIST) Cybersecurity Framework.

We engage third party experts to assist with numerous aspects of our cybersecurity program, including vulnerability assessment scans, penetration tests and security assessments.

These outside experts are utilized on a rotating basis to enable us to receive multiple viewpoints on the security of our technological resources.

Additionally, from time to time, our internal audit function, reviews and assesses various aspects of our cybersecurity program.

We also engage in threat intelligence monitoring, including monitoring the dark web and zero-day vulnerability and attack information, and have processes in place to assess the potential cybersecurity impact or risk of any identified threats on our company, including potential impacts on our business partners and other parties with whom we share information.

We actively engage with industry groups for peer benchmarking purposes and to stay current on best practices.

We rely heavily on our vendors and other third party service providers in our clinical development activities as well as to manufacture and deliver our products, and a cybersecurity incident at a vendor or other third party service provider could have a material and adverse impact on our business, results of operations and financial condition.

We have further processes in place to assess the cybersecurity risks associated with our vendors and other third-party service providers, and we require such providers to take appropriate precautions to protect our data and to notify us promptly in the event of any known or suspected data breach or cyber incident.

Our cybersecurity program is integrated into our broader approach to risk management, and ultimate oversight for the program sits with our Board of Directors.

The Board of Directors is aided by its Audit and Finance Committee, which regularly reviews our cybersecurity program with management and reports to the Board of Directors.

Cybersecurity reviews by the Audit and Finance Committee or the Board of Directors generally occur at least twice annually, or more frequently as determined to be necessary or advisable.

Incyte’s Chief Information Security Officer (CISO) runs our cybersecurity program.

Our CISO, who holds numerous cybersecurity and related certifications, including Certified Information Systems Security Professional, reports in to our Chief Information Officer (CIO).

Our CISO and CIO have extensive experience assessing and managing cybersecurity programs and cybersecurity risk.

They regularly report directly to the Audit and Finance Committee or the Board of Directors on our cybersecurity program and our efforts to prevent, detect, mitigate and remediate cybersecurity incidents.

In addition, we have an escalation process in place to inform senior management and the Board of Directors of any material issues as they arise.

Our large molecule production facility is located in Yverdon, Switzerland.

Also in October 2019, we entered into an agreement to purchase additional adjacent property for $50.0 million to expand our global headquarters.

Under that agreement, closing of the purchase is subject to certain standard closing conditions, including an initial diligence period and a subsequent approval period.

In July 2018, we purchased land in Yverdon, Switzerland upon which we are building a large molecule production facility.

Construction commenced in July 2018 and inspection from competent authorities was finalized in March 2022.

In June 2022 Swissmedic authorities granted the GMP drug manufacturing license for this facility.

*Hervé Hoppenot,* age [removed: 63,] [added: 64,] joined Incyte as President and Chief Executive Officer and a [removed: Director,] [added: Director] in January 2014 and was appointed Chairman of the Board in May 2015.

[removed: *Dashyant Dhanak*,] [added: *Christiana Stamoulis,*] age [removed: 62,] [added: 53,] joined Incyte in [removed: December 2018] [added: February 2019] as Executive Vice [removed: President,] [added: President and] Chief [removed: Scientific] [added: Financial] Officer.

Dickinson*, age [removed: 55,] [added: 56,] has served as Executive Vice President and General Manager, [removed: Europe] [added: Europe,] since June 2019 and joined Incyte as Senior Vice President and General Manager, Europe in June 2016.

Flannelly*, age [removed: 65,] [added: 66,] has served as Executive Vice President and General Manager, North America since June 2015 and joined Incyte as Executive Vice President, Business Development and Strategic Planning in August 2014.

Dr. Flannelly earned his doctorate in pharmacy from the University of Maryland, School of Pharmacy, his master’s degree in business administration from the University of Baltimore, and his B.S. [removed: degree] in Pharmacy from Massachusetts College of Pharmacy.

*Vijay Iyengar*, age [removed: 50,] [added: 51,] joined Incyte in May 2016 as Executive Vice President, Global Strategy and Corporate Development.

Dr. Iyengar received his B.S. [removed: degree] in Biology from Stanford University and earned his M.D. from Harvard Medical School.

*Michael Morrissey*, age [removed: 59,] [added: 60,] has served as Executive Vice President and Head of Global Technical Operations since June 2019 and joined Incyte in January 2016 as Corporate Senior Vice President and Head of Global Technical Operations.

[removed: Pasquale*,] [added: *Sheila Denton*,] age [removed: 57,] [added: 58,] joined Incyte in [removed: April 2018] [added: October 2023] as Executive Vice [removed: President and] [added: President,] General [removed: Counsel.][added: Counsel and Corporate Secretary.]

*Steven Stein,* age [removed: 56,] [added: 57,] has served as Executive Vice President and Chief Medical Officer since May 2016 and joined Incyte as Senior Vice President and Chief Medical Officer in March 2015.

Dr. Stein held a post-doctoral fellowship in hematology/oncology at the University of Pennsylvania from 1998 to 2001, and earned his M.D. from the University of Witwatersrand in Johannesburg, South [removed: Africa] [added: Africa,] in 1990.

Swain*, age [removed: 65,] [added: 66,] has served as Executive Vice President, Human Resources since August 2002 and joined Incyte as Senior Vice President of Human Resources in January 2002.

*Pablo J.

Cagnoni,* age 60, joined Incyte in June 2023 as President and Head of Research and Development.

From November 2022 to May 2023, Dr. Cagnoni served as Chief Executive of Laronde (now Sail Biomedicines), a Flagship Pioneering Company, and Executive Partner at Flagship Pioneering.

Prior to joining Laronde and Flagship, he served as President and Chief Executive Officer of Rubius Therapeutics, Inc., a biotechnology company, from June 2018 until November 2022.

From May 2015 until June 2018, Dr. Cagnoni served as President and Chief Executive Officer of Tizona Therapeutics, Inc., a privately held biotechnology company.

Dr. Cagnoni previously served as President of Onyx Pharmaceuticals, Inc., a biopharmaceutical company, from October 2013 to April 2015 and Executive Vice President, Global Research and Development and Technical Operations from March 2013 to October 2013.

Prior to Onyx, Dr. Cagnoni was Senior Vice President and Global Head of Clinical Development at Novartis Oncology from October 2009 to March 2013.

From 2007 to 2009, Dr. Cagnoni was Senior Vice President and Chief Medical Officer at Allos Therapeutics (acquired by Spectrum Pharmaceuticals) and, prior to that, Chief Medical Officer of OSI Pharmaceuticals (acquired by Astellas Pharma Inc.).

Dr. Cagnoni received an M.D. from the University Buenos Aires School of Medicine, and completed post-doctoral work in Hematology and Oncology at the Mount Sinai Medical Center, New York, and in Stem Cell Transplantation at the University of Colorado Health Sciences Center.

Ms. Denton most recently served as Senior Vice President, General Counsel and Corporate Secretary of Boehringer Ingelheim USA, Inc., where she was responsible for the legal, compliance and policy teams for the human health, animal health and biopharmaceutical businesses.

During her 19-year tenure with Boehringer Ingelheim, Ms. Denton held a number of other key leadership positions both in the United States and abroad, in multiple areas such as acquisitions, the generic businesses, and litigation.

Prior to joining Boehringer Ingelheim, Ms. Denton was a partner in a New England-based law firm.

Ms. Denton received her J.D. from Western New England College School of Law, and her B.S. in Business and Political Science from Sacred Heart University.

Mr. Hoppenot is also a director of Cellectis S.A.

Prior to joining Incyte, Dr. Dhanak served as Vice President and Head of Discovery Sciences of Janssen Research & Development, LLC, a wholly-owned subsidiary of Johnson & Johnson, a pharmaceutical company, from 2013 until November 2018.

Prior to his tenure at Janssen, Dr. Dhanak spent 25 years at GlaxoSmithKline, a pharmaceutical company, in positions of increased responsibility across multiple disease areas, including his last position as Vice President and Head of the Cancer Epigenetics Discovery Performance Unit.

Dr. Dhanak received a B.S. in Chemistry from the University of Manchester Institute of Science and Technology and his Ph.D. from the University of London.

He completed his postdoctoral research in natural product synthesis at Northwestern University.

*Maria E.

Prior to joining Incyte, Ms. Pasquale joined Incyte from Celgene Corporation, a biopharmaceutical company, where for 17 years she held positions of increasing levels of responsibility, including Chief Counsel; Senior Vice President, Legal and Deputy General Counsel and Assistant Corporate Secretary, and, most recently, Executive Vice President and Global Chief Compliance Officer.

Prior to her tenure at Celgene, Ms. Pasquale spent a decade supporting pharmaceutical clients as a global patent and litigation attorney at Pennie & Edmonds LLP in New York (now part of Jones Day).

Before her career in law, Ms. Pasquale was an Assistant Research Scientist at the Institute for Basic Research and the Cold Spring Harbor Laboratory.

Ms. Pasquale holds a J.D. from Brooklyn Law School and a B.S. in biochemistry from the State University of New York at Stony Brook.

*Christiana Stamoulis,* age 52, joined Incyte in February 2019 as Executive Vice President and Chief Financial Officer.

Our common stock, $.001 par value per share, is traded on The Nasdaq Global Select Market under the symbol “INCY.” As of December 31, [removed: 2022,] [added: 2023,] our common stock was held by [removed: 115] [added: 112] stockholders of record.

| [Report of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm](#if009c8ccc24c44da8511b38de3b79441_79)] [added: Firm](#ife611127b0c9404b8cdc4fe0d4e43090_97)] (PCAOB ID: 42) | | | [removed: [79](#if009c8ccc24c44da8511b38de3b79441_79)] [added: [78](#ife611127b0c9404b8cdc4fe0d4e43090_97)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 202](#if009c8ccc24c44da8511b38de3b79441_82)[2](#if009c8ccc24c44da8511b38de3b79441_82)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_100)[3](#ife611127b0c9404b8cdc4fe0d4e43090_100)] [and [removed: 202](#if009c8ccc24c44da8511b38de3b79441_82)[1](#if009c8ccc24c44da8511b38de3b79441_82)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_100)[2](#ife611127b0c9404b8cdc4fe0d4e43090_100)] | | | [removed: [81](#if009c8ccc24c44da8511b38de3b79441_82)] [added: [80](#ife611127b0c9404b8cdc4fe0d4e43090_100)] | | |

| [Consolidated Statements of Operations for the years ended December 31, [removed: 202](#if009c8ccc24c44da8511b38de3b79441_85)[2](#if009c8ccc24c44da8511b38de3b79441_85)[, 202](#if009c8ccc24c44da8511b38de3b79441_85)[1](#if009c8ccc24c44da8511b38de3b79441_85)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[3](#ife611127b0c9404b8cdc4fe0d4e43090_103)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[2](#ife611127b0c9404b8cdc4fe0d4e43090_103)] [and [removed: 20](#if009c8ccc24c44da8511b38de3b79441_85)[2](#if009c8ccc24c44da8511b38de3b79441_85)[0](#if009c8ccc24c44da8511b38de3b79441_85)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[1](#ife611127b0c9404b8cdc4fe0d4e43090_103)] | | | [removed: [82](#if009c8ccc24c44da8511b38de3b79441_85)] [added: [81](#ife611127b0c9404b8cdc4fe0d4e43090_103)] | | |

| [Consolidated Statements of [removed: Comprehensive Income (Loss) for] [added: Comprehensive](#ife611127b0c9404b8cdc4fe0d4e43090_106) [Income](#ife611127b0c9404b8cdc4fe0d4e43090_106) [(Loss)](#ife611127b0c9404b8cdc4fe0d4e43090_106) [for] the years ended December 31, [removed: 202](#if009c8ccc24c44da8511b38de3b79441_88)[2](#if009c8ccc24c44da8511b38de3b79441_88)[, 202](#if009c8ccc24c44da8511b38de3b79441_88)[1](#if009c8ccc24c44da8511b38de3b79441_88)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[3](#ife611127b0c9404b8cdc4fe0d4e43090_106)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[2](#ife611127b0c9404b8cdc4fe0d4e43090_106)] [and [removed: 20](#if009c8ccc24c44da8511b38de3b79441_88)[20](#if009c8ccc24c44da8511b38de3b79441_88)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[1](#ife611127b0c9404b8cdc4fe0d4e43090_106)] | | | [removed: [83](#if009c8ccc24c44da8511b38de3b79441_88)] [added: [82](#ife611127b0c9404b8cdc4fe0d4e43090_106)] | | |

| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [removed: 202](#if009c8ccc24c44da8511b38de3b79441_91)[2](#if009c8ccc24c44da8511b38de3b79441_91)[, 202](#if009c8ccc24c44da8511b38de3b79441_91)[1](#if009c8ccc24c44da8511b38de3b79441_91)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[3](#ife611127b0c9404b8cdc4fe0d4e43090_109)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[2](#ife611127b0c9404b8cdc4fe0d4e43090_109)] [and [removed: 20](#if009c8ccc24c44da8511b38de3b79441_91)[20](#if009c8ccc24c44da8511b38de3b79441_91)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[1](#ife611127b0c9404b8cdc4fe0d4e43090_109)] | | | [removed: [84](#if009c8ccc24c44da8511b38de3b79441_91)] [added: [83](#ife611127b0c9404b8cdc4fe0d4e43090_109)] | | |

| [Consolidated Statements of Cash Flows for the years ended December 31, [removed: 202](#if009c8ccc24c44da8511b38de3b79441_94)[2](#if009c8ccc24c44da8511b38de3b79441_94)[, 202](#if009c8ccc24c44da8511b38de3b79441_94)[1](#if009c8ccc24c44da8511b38de3b79441_94)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[3](#ife611127b0c9404b8cdc4fe0d4e43090_112)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[2](#ife611127b0c9404b8cdc4fe0d4e43090_112)] [and [removed: 20](#if009c8ccc24c44da8511b38de3b79441_94)[20](#if009c8ccc24c44da8511b38de3b79441_94)] [added: 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[1](#ife611127b0c9404b8cdc4fe0d4e43090_112)] | | | [removed: [85](#if009c8ccc24c44da8511b38de3b79441_94)] [added: [84](#ife611127b0c9404b8cdc4fe0d4e43090_112)] | | |

| [Notes to the Consolidated Financial [removed: Statements](#if009c8ccc24c44da8511b38de3b79441_97)] [added: Statements](#ife611127b0c9404b8cdc4fe0d4e43090_115)] | | | [removed: [86](#if009c8ccc24c44da8511b38de3b79441_97)] [added: [85](#ife611127b0c9404b8cdc4fe0d4e43090_115)] | | |

We have audited the accompanying consolidated balance sheets of Incyte Corporation (the Company) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 7, 2023] [added: 13, 2024] expressed an unqualified opinion thereon.

Critical Audit [removed: Matters][added: Matter]

The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that: (1) [removed: relate] [added: relates] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The communication of [added: the] critical audit [removed: matters] [added: matter] does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matters] [added: matter] below, providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]

| *Description of the Matter* | | | As discussed in Note 1 to the consolidated financial statements, the Company recognizes revenues for product received by its customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates. Liabilities related to sales allowances are presented within accrued and other current liabilities on the consolidated balance sheet and totaled [removed: $192.1] [added: $279.9] million as of December 31, [removed: 2022.] [added: 2023.] Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and highly judgmental due to the significant estimation uncertainty involved in management’s assumptions, including the levels of expected utilization of these rebates based on the amount of drugs sold to eligible patients, as well as the complexity of the government mandated calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. | | |

| [added: Acquisition-related contingent consideration] | | | [removed: Valuation of acquisition-related contingent consideration liability] [added: 38,422] | | | [added: | | | 36,538 | | |]

| | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |

| Cash and cash equivalents | | | $ | [removed: 2,951,422] [added: 3,213,376] | | | | | $ | [removed: 2,057,440] [added: 2,951,422] | |

| Marketable securities—available-for-sale (amortized cost [removed: $292,580] [added: $442,816] and [removed: $291,871] [added: $292,580] as of December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] respectively; allowance for credit losses $0 as of December 31, [removed: 2022] [added: 2023] and [removed: 2021)] [added: 2022)] | | | [removed: 287,543] [added: 442,667] | | | | | | [removed: 290,752] [added: 287,543] | | |

| Accounts receivable | | | [removed: 644,879] [added: 743,557] | | | | | | [removed: 616,300] [added: 644,879] | | |

| Inventory | | | [removed: 41,995] [added: 62,972] | | | | | | [removed: 27,904] [added: 41,995] | | |

| Prepaid expenses and other current assets | | | [removed: 167,011] [added: 182,830] | | | | | | [removed: 126,278] [added: 167,011] | | |

| Total current assets | | | [removed: 4,092,850] [added: 4,645,402] | | | | | | [removed: 3,118,674] [added: 4,092,850] | | |

| Restricted cash | | | [removed: 1,698] [added: 1,845] | | | | | | [removed: 1,720] [added: 1,698] | | |

| Long term investments | | | [removed: 133,676] [added: 187,716] | | | | | | [removed: 221,266] [added: 133,676] | | |

| Inventory | | | [removed: 78,964] [added: 206,965] | | | | | | [removed: 29,034] [added: 78,964] | | |

| Property and equipment, net | | | [removed: 739,310] [added: 751,513] | | | | | | [removed: 723,920] [added: 739,310] | | |

| Finance lease right-of-use assets, net | | | [removed: 26,298] [added: 25,535] | | | | | | [removed: 27,548] [added: 26,298] | | |

| Other intangible assets, net | | | [removed: 129,219] [added: 123,545] | | | | | | [removed: 150,755] [added: 129,219] | | |

| Deferred income tax asset | | | [removed: 457,941] [added: 631,886] | | | | | | [removed: 467,538] [added: 457,941] | | |

| Other assets, net | | | [removed: 25,435] [added: 52,107] | | | | | | [removed: 37,304] [added: 25,435] | | |

| Total assets | | | $ | [removed: 5,840,984] [added: 6,782,107] | | | | | $ | [removed: 4,933,352] [added: 5,840,984] | |

| Accounts payable | | | $ | [removed: 277,546] [added: 109,601] | | | | | $ | [removed: 172,110] [added: 277,546] | |

| Accrued compensation | | | [removed: 138,761] [added: 153,348] | | | | | | [removed: 108,962] [added: 138,761] | | |

| Accrued and other current liabilities | | | [removed: 701,053] [added: 935,569] | | | | | | [removed: 533,595] [added: 701,053] | | |

| Finance lease liabilities | | | [removed: 3,179] [added: 3,439] | | | | | | [removed: 2,635] [added: 3,179] | | |

| Acquisition-related contingent consideration | | | [removed: 36,538] [added: $] | [added: —] | | | | | [removed: 37,006] [added: $] | [added: —] | | [added: | | | $ | 212,000 | | | | | $ | 212,000 | |]

| Total current liabilities | | | [removed: 1,157,077] [added: 1,240,379] | | | | | | [removed: 854,308] [added: 1,157,077] | | |

| Acquisition-related contingent consideration | | | [removed: 184,462] [added: 173,578] | | | | | | [removed: 206,994] [added: 184,462] | | |

| Finance lease liabilities | | | [removed: 30,083] [added: 29,162] | | | | | | [removed: 31,632] [added: 30,083] | | |

| Other liabilities | | | [removed: 99,243] [added: 149,151] | | | | | | [removed: 70,414] [added: 99,243] | | |

February 13, 2024

| | | | 2023 | | | | | | 2022 | | |

| Net income | | | $ | 597,599 | | | | | $ | 340,660 | | | | | $ | 948,581 | |

| Stock compensation | | | — | | | | | | 216,475 | | | | | | — | | | | | | — | | | | | | 216,475 | | |

| Other comprehensive loss | | | — | | | | | | — | | | | | | (1,963) | | | | | | — | | | | | | (1,963) | | |

| Net income | | | — | | | | | | — | | | | | | — | | | | | | 597,599 | | | | | | 597,599 | | |

| Balances at December 31, 2023 | | | $ | 224 | | | | | $ | 5,016,122 | | | | | $ | 13,106 | | | | | $ | 160,385 | | | | | $ | 5,189,837 | |

| Net income | | | $ | 597,599 | | | | | $ | 340,660 | | | | | $ | 948,581 | |

| Other, net | | | 22,579 | | | | | | 17,366 | | | | | | 1,417 | | |

| Loss on change in fair value of acquisition-related contingent consideration | | | 29,202 | | | | | | 12,149 | | | | | | 14,741 | | |

| Payments for intangible assets | | | (15,000) | | | | | | — | | | | | | — | | |

*Inventory.* Inventories are valued at the lower of cost and net realizable value.

We use the specific identification method to account for commercial product manufactured by third-party contractors, which is our predominant source of inventory.

We apply the first-in, first-out (FIFO) method to inventories produced at our internal manufacturing facility located in Yverdon, Switzerland.

Inventories consist of costs of materials, including shipping and handling fees, third-party contract manufacturing, and allocable overhead associated with the production of our commercialized products.

Intangible assets with finite lives are tested for recoverability whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.

Cost of product revenues includes all product related costs and royalties owed under our collaboration and license agreements, contingent on certain conditions.

In addition, cost of product revenues includes the amortization of our licensed intellectual property for ICLUSIG and the amortization of capitalized milestone payments, using the straight-line method over the respective estimated useful lives, which range between approximately 11 to 14 years.

In November 2023, the Financial Accounting Standards Board (the "FASB") issued ASU No. 2023-07, "*Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures*." This amended guidance applies to all public entities and aims to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, to enable investors to develop more decision-useful financial analyses.

This guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024.

Early adoption is permitted.

We are currently analyzing the impact that ASU No. 2023-07 will have on our consolidated financial statements.

In December 2023, the FASB issued ASU No. 2023-09, "*Income Taxes (Topic 740): Improvements to Income Tax Disclosures*." This amended guidance applies to all entities and broadly aims to enhance the transparency and decision usefulness of income tax disclosures.

For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2024.

Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance.

We are currently analyzing the impact that ASU No. 2023-09 will have on our consolidated financial statements.

| | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

| ZYNYZ revenues, net | | | 1,250 | | | | | | — | | | | | | — | | |

| Milestone and contract revenues | | | 7,000 | | | | | | 165,000 | | | | | | 95,000 | | |

| December 31, 2023 | | | | | | | | | | | | | | | | | | | | | | | |

| Debt securities (government) | | | $ | 442,816 | | | | | | | | | | | $ | (149) | | | | | $ | 442,667 | |

| Total assets | | | $ | 3,401,092 | | | | | $ | 442,667 | | | | | $ | — | | | | | $ | 3,843,759 | |

| | | | 2023 | | | | | | 2022 | | |

| | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

During December 2023, we made a $20.0 million development milestone payment to former Villaris stockholders for the initiation of the Phase 1 clinical trial of INCA034460 as a treatment for vitiligo, which was expensed to research and development expense on the consolidated statement of operations for the year ended December 31, 2023.

| | | | 2023 | | | | | | 2022 | | |

| API and Work-in-process | | | 209,793 | | | | | | 54,455 | | |

In September 2023, we recognized a $5.0 million regulatory milestone for the approval of JAKAVI (ruxolitinib) in GVHD by the Japanese Ministry of Health, Labour and Welfare.

Since the date of the amendment through December 31, 2023, we have fully paid Lilly milestones totaling $40.0 million.

Under this agreement, we are responsible for all costs associated with discovery, preclinical, clinical development and commercialization activities for the currently active programs.

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| *Description of the Matter* | | | As discussed in Note 3 to the consolidated financial statements, the Company’s acquisition-related contingent consideration liability, which consists of certain future royalty obligations on future net revenues of ICLUSIG, is remeasured to its estimated fair value each reporting period, with changes in fair value recorded in the consolidated statements of operations. As of December 31, 2022, the acquisition-related contingent consideration liability was $221.0 million. Auditing the valuation of the acquisition-related contingent consideration liability was complex and highly judgmental due to the significant estimation required in determining the fair value. In particular, the fair value estimate was sensitive to significant assumptions such as the discount rate and projected future net revenues of ICLUSIG, which are affected by expectations about future industry, market and economic conditions, and are forward-looking and inherently uncertain. | | |

| *How We Addressed the Matter in Our Audit* | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s valuation of the acquisition-related contingent consideration liability. For example, we tested the Company's controls over management’s review of the valuation model, including controls over the significant assumptions utilized in the calculation, such as the discount rate and the projected future net revenues of ICLUSIG. To test the estimated fair value of the acquisition-related contingent consideration liability, we performed audit procedures that included, among others, assessing the terms of the arrangement, evaluating the methodology used, and testing the significant assumptions discussed above used by the Company in its analysis. We involved our valuation specialists to assist in the evaluation of the significant assumptions and methodology used by the Company. We also compared the significant assumptions to current industry, market and economic trends and to the Company's budgets and forecasts. In addition, we assessed the historical accuracy of management’s estimates against actual performance. | | |

February 7, 2023

| | | | | | | | | | | | | | | | | | |

| Balances at December 31, 2019 | | | $ | 216 | | | | | $ | 4,044,490 | | | | | $ | (15,542) | | | | | $ | (1,430,758) | | | | | $ | 2,598,406 | |

| Issuance of 368,886 shares of Common Stock upon conversion of Convertible Senior Notes due 2020 | | | — | | | | | | 18,999 | | | | | | — | | | | | | — | | | | | | 18,999 | | |

| Stock compensation | | | — | | | | | | 178,527 | | | | | | — | | | | | | — | | | | | | 178,527 | | |

| Other comprehensive income | | | — | | | | | | — | | | | | | 182 | | | | | | — | | | | | | 182 | | |

| Net loss | | | — | | | | | | — | | | | | | — | | | | | | (295,697) | | | | | | (295,697) | | |

| Unrealized foreign exchange losses (gains) and other, net | | | 17,366 | | | | | | 1,417 | | | | | | 546 | | |

| Reclassification to common stock and additional paid in capital in connection with conversions of 1.25% convertible senior notes due 2020 | | | $ | — | | | | | $ | — | | | | | $ | 18,999 | |

Inventory costs are primarily accounted for under the specific identification method.

Upon evaluating and weighting both positive and negative evidence, we concluded that we should release the valuation allowance on the majority of our U.S. deferred tax assets as of December 31, 2021.

Additionally, beginning in January 2020, the amount of spending required by eligible patients in the Medicare Part D insurance coverage gap increased 30% due to the expiration of a provision in the Patient Protection and Affordable Care Act, which now results in a change in the True Out of Pocket (TrOOP) calculation methodology.

The methodological change has resulted in an increase in required spending by patients and, in turn, an increase in manufacturers’ contributions on behalf of patients in the Medicare Part D insurance coverage gap.

Cost of product revenues includes all product related costs.

In addition, cost of product revenues include royalties owed under our collaboration and license agreements, contingent on certain conditions, and the amortization of our licensed intellectual property for ICLUSIG using the straight-line method over the estimated useful life of 12.5 years from the date of acquisition on June 1, 2016 of all of the outstanding shares of ARIAD Pharmaceuticals (Luxembourg) S.à.r.l.

(since renamed Incyte Biosciences Luxembourg S.à.r.l.) from ARIAD Pharmaceuticals, Inc. (“ARIAD”).

As of December 31, 2022, there were no new accounting pronouncements issued or adopted that may have a material impact on the Company's financial position, results of operations, or cash flows upon their adoption.

| December 31, 2021 | | | | | | | | | | | | | | | | | | | | | | | |

| Debt securities (government) | | | $ | 291,871 | | | | | | | | | | | $ | (1,119) | | | | | $ | 290,752 | |

| Total assets | | | $ | 2,278,706 | | | | | $ | 290,752 | | | | | $ | — | | | | | $ | 2,569,458 | |

| Customer F | | | 14 | | % | | | | 8 | | % | | | | 5 | | % |

| Work-in-process | | | 54,455 | | | | | | 39,895 | | |

Inventories, stated at the lower of cost and net realizable value, consist of raw materials, work-in-process and finished goods.

In April 2022, we recognized a $15.0 million regulatory milestone for the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the EMA that recommends granting marketing authorization for capmatinib (TABRECTA) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer.

Additionally, in May 2022, we recognized a $45.0 million regulatory milestone as a result of the European Commission’s approval of JAKAVI (ruxolitinib) as the first post-steroid treatment for acute and chronic GVHD.

In June 2022, we recognized a $40.0 million regulatory milestone for the FDA approval of OLUMIANT as a first-in-disease systemic treatment for adults with severe alopecia areata.

Additionally, in June 2022, we recognized a $20.0 million regulatory milestone for the European Commission’s approval for OLUMIANT for the treatment of adults with severe alopecia areata, and a $10.0 million regulatory milestone for the Ministry of Health, Labour and Welfare of Japan’s approval for OLUMIANT for the treatment of adults with severe alopecia areata in Japan.

In May 2019, the approval of JAKAFI in steroid-refractory acute GVHD triggered a $20.0 million milestone payment to Lilly.

In March 2022, the positive recommendation from the European Medicines Agency for regulatory approval of ruxolitinib in the GVHD field triggered an additional $20.0 million milestone payment to Lilly, which was recorded as research and development expense in our consolidated statements of operations.

Under the terms of the amended agreement, we received exclusive worldwide development and commercialization rights to four checkpoint modulators directed against GITR, OX40, LAG-3 and TIM-3 as well as two undisclosed targets.

Targets may be designated profit-share programs, where all costs and profits are shared equally by us and Agenus, or royalty-bearing programs, where we are responsible for all costs associated with discovery, preclinical, clinical development and commercialization activities.

There are currently no profit-share programs.

For GITR and one undisclosed target, Agenus will be eligible to receive 15% royalties on global net sales.

On October 19, 2022 we notified Agenus that we were terminating the OX40 project.

In addition, in 2017 we also agreed to purchase 10.0 million shares of Agenus common stock for an aggregate purchase price of $60.0 million in cash, or $6.00 per share.

In 2020, we sold an aggregate of approximately 3.7 million shares of Agenus common stock resulting in gross proceeds of approximately $17.2 million.

*Changes in internal control over financial reporting.* There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) for the quarter ended December 31, [removed: 2022,] [added: 2023,] that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Based on our evaluation under the framework in *Internal Control—Integrated Framework*, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2022.][added: 2023.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report which is included herein.

We have audited Incyte Corporation’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Incyte Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes and our report dated February [removed: 7, 2023] [added: 13, 2024] expressed an unqualified opinion thereon.

February 13, 2024

February 7, 2023

(b) During the three months ended December 31, 2023, no director of officer (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934) of our Company adopted a prearranged trading plan relating to our common stock and intended to satisfy the affirmative defense of Rule 10b5–1(c) under the Securities Exchange Act of 1934.

During the three months ended December 31, 2023, no director or officer (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934) of our Company adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities, whether or not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).

None.

PART III

Not applicable.

PART III

The information required by this item (with respect to Directors) is incorporated by reference from the information under the caption “Election of Directors” contained in our Proxy Statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for our [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be held on June [removed: 14, 2023] [added: 12, 2024] (the “Proxy Statement”).

| 3(ii) | | | | | | [Bylaws of the Company, as amended as [removed: of February 18, 2021 (incorporated] [added: of](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [July 27, 2023](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [(incorporated] by reference to Exhibit 3.1 to the [removed: Company’s Current Report] [added: Company’s](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [Quarterly](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [Report] on [removed: Form 8-K filed February 19, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000110465921025501/tm217190d1_ex3-1.htm)] [added: Form](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [10-](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)[Q](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [for the quarter ended June 30, 2023](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)] | | |

| 10.1# | | | | | | [Incyte Corporation Amended and Restated 2010 Stock Incentive Plan, as [removed: amended and restated May] [added: amended](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [on](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[April] 13, [removed: 2021 (incorporated] [added: 202](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[3](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [(incorporated] by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K [removed: filed May 27, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000110465921073209/tm2117670d1_ex10-1.htm)] [added: filed](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [June 15, 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)] | | |

| 10.8# | | | | | | [1997 Employee Stock Purchase Plan of Incyte Corporation, as [removed: amended and restated effective November 17, 2020 (incorporated] [added: amended](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [on April 13, 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [(incorporated] by reference to Exhibit [removed: 10.8 to] [added: 10.](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[2](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [to] the [removed: Company’s Annual Report] [added: Company’s](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [Current R](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[eport] on [removed: Form 10-K for the year ended December 31, 2020).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021000825/incy-20201231xex10d8.htm)] [added: Form](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [8-K filed Jun](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[e 15, 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)] | | |

| 10.9# | | | | | | [Form of Employment Agreement between the Company and Barry P. Flannelly (effective as of August 11, 2014), Christiana Stamoulis (effective as of February 11, 2019), Steven H. Stein (effective as of March 2, 2015), Vijay K. Iyengar (effective as of May 9, [removed: 2016), Maria E. Pasquale (effective as of April 9, 2018) and Dashyant Dhanak (effective as] [added: 2016),](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [Pablo J. Cagnoni (effective](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [as of](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [June 7, 2023](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm)[)](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [and Sheila A. Denton (effective](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [as] of [removed: December 10, 2018) (incorporated] [added: October 2, 2023)](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [(incorporated] by reference to Exhibit 10.14 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2012).](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) | | |

| [removed: 10.13†] [added: 10.14†] | | | | | | [Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex101e8f74d.htm) | | |

| [removed: 10.13.1†] [added: 10.14.1†] | | | | | | [Amendment, dated as of April 5, 2016, to Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.1.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10117002c.htm) | | |

| [removed: 10.13.2††] [added: 10.14.2††] | | | | | | [Amendment, dated as of March 20, 2020, to the Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020005185/incy-20200331xex10d2.htm) | | |

| [removed: 10.14†] [added: 10.15†] | | | | | | [License, Development and Commercialization Agreement, entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1020eebfd.htm) | | |

| [removed: 10.14.1†] [added: 10.15.1†] | | | | | | [Amendment, dated June 22, 2010, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1021f3558.htm) | | |

| [removed: 10.14.2†] [added: 10.15.2†] | | | | | | [Third Amendment, entered into effective March 31, 2016, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10225e24a.htm) | | |

| [removed: 10.14] [added: 10.15] .3† | | | | | | [Fourth Amendment, entered into effective December 13, 2016, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.21.4 to Amendment No. 2 on Form 10-K/A to the Company’s Annual Report on Form 10-K for the year ended December 31, 2016).](http://www.sec.gov/Archives/edgar/data/879169/000110465917043033/a17-15971_1ex10d21d4.htm) | | |

| [removed: 10.14.4††] [added: 10.15.4††] | | | | | | [Letter Agreement, dated May 13, 2020, between the Company and Eli Lilly and Company, together with related Letter of Understanding, dated March 5, 2020, between the Company and Eli Lilly and Company, each relating to License, Development and Commercialization Agreement entered into as of December 18, 2009 by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020009164/incy-20200630xex10d1.htm) | | |

| [removed: 10.15] [added: 10.16] † | | | | | | [License, Development and Commercialization Agreement, dated as of January 9, 2015, by and among the Company, Incyte Europe S.à.r.l. (a wholly owned subsidiary of the Company), Agenus Inc. and 4-Antibody AG (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015).](http://www.sec.gov/Archives/edgar/data/879169/000110465915032614/a15-7158_1ex10d1.htm) | | |

| [removed: 10.15.1†] [added: 10.16.1†] | | | | | | [First Amendment, dated as of February 14, 2017, to License, Development and Commercialization Agreement entered into as of January 9, 2015, by and among the Company, Incyte Europe S.à.r.l. (a wholly owned subsidiary of the Company), Agenus Inc. and Agenus Switzerland Inc. (f/k/a 4-Antibody AG) (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017).](http://www.sec.gov/Archives/edgar/data/879169/000155837017003529/incy-20170331ex1018c8960.htm) | | |

| [removed: 10.16] [added: 10.17] | | | | | | [Registration Rights Agreement, dated as of February 12, 2016, between the Company and 667, L.P., Baker Brothers Life Sciences, L.P. and 14159, L.P. (incorporated by reference to Exhibit 10.28 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015).](http://www.sec.gov/Archives/edgar/data/879169/000155837016003196/incy-20151231ex10283b05a.htm) | | |

| [removed: 10.17] [added: 10.18] | | | | | | [Revolving Credit and Guaranty Agreement, dated as of August 18, 2021, among the Company, the guarantors party thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as Administrative Agent (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021014131/incy-20210930xex10d1.htm) | | |

| 21.1* | | | | | | [Subsidiaries of the [removed: Company.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit211-12312022.htm)] [added: Company.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit211-12312023.htm)] | | |

| 23.1* | | | | | | [Consent of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit231-12312022.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit231-12312023.htm)] | | |

| 31.1* | | | | | | [Rule 13a 14(a) Certification of the Chief Executive [removed: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit311-12312022.htm)] [added: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit311-12312023.htm)] | | |

| 31.2* | | | | | | [Rule 13a 14(a) Certification of the Chief Financial [removed: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit312-12312022.htm)] [added: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit312-12312023.htm)] | | |

| 32.1 | | | | | | [Statement of the Chief Executive Officer under Section 906 of the Sarbanes Oxley Act of 2002 (18 U.S.C Section [removed: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit321-12312022.htm)] [added: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit321-12312023.htm)] | | |

| 32.2 | | | | | | [Statement of the Chief Financial Officer under Section 906 of the Sarbanes Oxley Act of 2002 (18 U.S.C Section [removed: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit322-12312022.htm)] [added: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit322-12312023.htm)] | | |

| 10.13# | | | | | | [Offer of Employment Letter, dated April 21, 2023, from the Company to Pablo J. Cagnoni (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit101-cagnoniofferlet.htm) | | |

| 10.18.1 | | | | | | [Amendment No. 1, dated as of May 10, 2023, to Revolving Credit and Guaranty Agreement dated as of August 18, 2021 among the Company, the guarantors party thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as Administrative Agent. (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit103-amendedcreditag.htm) | | |

| 97.1* | | | | | | [Incyte Corporation Policy for Recoupment of Erroneously Awarded Compensation.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit971-revisedclawback.htm) | | |

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Exhibit Number | | | | | | Description of Document | | |

| | | | | | | [removed: *Chairman, President,] [added: *President] and Chief Executive Officer* | | |

Date: February [removed: 7, 2023][added: 13, 2024]

[removed: Pasquale,] [added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes] and [added: appoints Hervé Hoppenot, Christiana Stamoulis, and Sheila Denton, and] each of them, his [added: or her] true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.

| /s/ HERVÉ HOPPENOT | | | | | | [removed: Chairman, President,] [added: President] and Chief Executive Officer (Principal Executive Officer) and [removed: Director] [added: Chairman of the Board] | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ CHRISTIANA STAMOULIS | | | | | | [added: Executive Vice President and] Chief Financial Officer (Principal Financial Officer) | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ THOMAS TRAY | | | | | | [removed: VP,] [added: Vice President and] Chief Accounting Officer (Principal Accounting Officer) | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ JULIAN C. BAKER | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ JEAN-JACQUES BIENAIMÉ | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ OTIS W. BRAWLEY | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ PAUL J. CLANCY | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ JACQUALYN A. FOUSE | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ EDMUND P. HARRIGAN | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ KATHERINE A. HIGH | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

| /s/ SUSANNE SCHAFFERT | | | | | | Director | | | | | | February [removed: 7, 2023] [added: 13, 2024] | | |

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Hervé Hoppenot, Christiana Stamoulis, and Maria E.