Incyte (INCY) 10-K risk factor changes: FY2022 vs FY2021

While we also sell ICLUSIG in the European Union, or EU, and other 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, [added: 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 OPZELURA in the Unites States for the treatment of certain indications of atopic [removed: dermatitis,] [added: dermatitis] and [added: vitiligo, and] our exclusive licensees sell OLUMIANT (baricitinib) for the treatment of specified rheumatoid arthritis and atopic dermatitis indications and TABRECTA for the treatment of a certain type of [removed: non small-cell] [added: non-small cell] lung cancer, we anticipate that JAKAFI product sales will continue to contribute a significant percentage of our total revenues over the next several years.

[removed: | | ● |] [added: -] the number of patients with intermediate or high-risk myelofibrosis, uncontrolled polycythemia vera or steroid-refractory [removed: acute] graft-versus-host disease who are diagnosed with the diseases and the number of such patients that may be treated with JAKAFI; [removed: |]

[removed: | | ● |] [added: -] the acceptance of JAKAFI by patients and the healthcare community; [removed: |]

[removed: | | ● |] [added: -] whether physicians, patients and healthcare payors view JAKAFI as therapeutically effective and safe relative to cost and any alternative [removed: therapies; |][added: therapies, as well as whether patients will continue to use JAKAFI;]

[removed: | | ● |] [added: -] the ability to obtain and maintain sufficient coverage or reimbursement by third-party payors and pricing; [removed: |]

[removed: | | ● |] [added: -] the ability of our third-party manufacturers to manufacture JAKAFI in sufficient quantities that meet all applicable quality standards; [removed: |]

[removed: | | ● |] [added: -] the ability of our company and our third-party providers to provide marketing and distribution support for JAKAFI; [removed: |]

[removed: | | ● |] [added: -] 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 [removed: prescriptions)] [added: prescriptions] and [added: 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”; [removed: |]

[removed: | | ● |] [added: -] the label and promotional claims allowed by the FDA; [removed: |]

[removed: | | ● |] [added: -] the maintenance of regulatory approval for the approved indications in the United States; and [removed: |]

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

In addition, revenues from our other products and our receipt of royalties under our collaboration [added: agreements, including our] agreements with Novartis for sales of JAKAVI outside the United States and TABRECTA globally and with Eli Lilly and Company for worldwide sales of [removed: OLUMIANT] [added: OLUMIANT,] will depend on factors similar to those listed above, with similar regulatory, pricing and reimbursement issues driven by applicable regulatory authorities and governmental and third-party payors affecting jurisdictions outside the United States.

[removed: | | ● |] [added: -] actions of federal, state and foreign governments and other third-party payors to implement or modify laws, regulations or policies addressing payment and reimbursement for drugs; [removed: |]

[removed: | | ● |] [added: -] 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; and [removed: |]

[removed: | | ● |] [added: -] 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 value. [removed: |]

[removed: 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.

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

[added: ” 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 payments due to budgetary constraints relating to the COVID-19 pandemic, 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, [added: PBM and pharmacy network relationships,] reimbursement strategies and governmental interactions.

[added: These regulations continue to apply after product marketing approval,] and cover, among other things, testing, manufacturing, quality control and assurance, labeling, advertising, promotion, risk mitigation, and adverse event reporting requirements.

[removed: | | ● |] [added: -] administrative and judicial sanctions, including warning letters; [removed: |]

[removed: | | ● |] [added: -] fines and other civil penalties; [removed: |]

[removed: | | ● |] [added: -] suspension or withdrawal of regulatory approval to market or manufacture our products; [removed: |]

[removed: | | ● |] [added: -] interruption of production; [removed: |]

[removed: | | ● |] [added: -] operating restrictions; [removed: |]

[removed: | | ● |] [added: -] product recall or seizure; [removed: |]

[removed: | | ● |] [added: -] injunctions; and [removed: |]

[removed: | | ● |] [added: -] criminal prosecution. [removed: |]

[removed: | | ● |] [added: -] lessen the frequency with which physicians decide to prescribe our products; [removed: |]

[removed: | | ● |] [added: -] encourage physicians to stop prescribing our products to their patients who previously had been prescribed our products; [removed: |]

[removed: | | ● |] [added: -] cause serious harm to patients that may give rise to product liability claims against us; and [removed: |]

[removed: | | ● |] [added: -] result in our need to withdraw or recall our products from the marketplace. [removed: |]

Any action initiated against us for violation of these laws, even if we successfully defend against it, could require the expenditure of significant resources and generate negative publicity, which could harm our business and operating [added: results, and any settlement of such action initiated against us, regardless of the merits, could result in the payment of significant amounts, which could harm our financial condition and operating] results.

[added: In any event, the commercial potential of our current] products [added: and any future products] may be reduced or eliminated if our competitors develop or acquire and commercialize generic or branded products that are safer or more effective, are more convenient or are less expensive than our products.

Present and potential competitors for JAKAFI [removed: could] 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 [removed: steroids and] [added: steroids,] injectable DUPIXENT (dupilimab) from Sanofi and Regeneron Pharmaceuticals, [added: Inc., and oral CIBINQO (abrocitinib) from Pfizer] Inc. [added: and RINVOQ (upadacitinib) from AbbVie Inc.]

Public health [removed: epidemics,] [added: epidemics and pandemics,] such as the COVID-19 pandemic, have adversely affected and could in the future adversely affect our business, results of operations, and financial condition.

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

[added: The extent to which the COVID-19 pandemic and the measures taken to limit COVID-19’s spread 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 future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak and any future resurgence of the outbreak, additional or modified government 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.

[removed: | | ● |] [added: -] 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. [removed: 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 or travel restrictions. |]

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

Factors similar to those listed above also apply to our collaborator Novartis for JAKAVI and TABRECTA in jurisdictions in which it has commercialization rights and to our collaborator Lilly for OLUMIANT all jurisdictions.

With respect to OLUMIANT, in August 2022 we and Lilly received notice letters with respect to ANDAs that requested approval to market generic versions of OLUMIANT prior to the expiration of the three U.S. Patents that expire in 2030.

- 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.

Having a significant portion of our employees work from home can strain our information technology infrastructure, which may affect our ability to operate effectively, may make us more susceptible to communications disruptions, and expose us to greater cybersecurity risks.

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.

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.

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.

And, for JAKAFI, while our strategy is to maintain a 24 month stock of active pharmaceutical ingredient, or API, inclusive of finished product, ruxolitinib phosphate might be used by us either to make JAKAFI or for ruxolitinib drug candidates in clinical trials.

Further, in August 2022, the Inflation Reduction Act of 2022 was enacted, which includes provisions allowing the federal government to negotiate prices for certain high-expenditure single source Medicare drugs, to impose penalties and to implement a potential excise tax for manufacturers that fail to comply with the negotiation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and to impose rebate liability on manufacturers that take price increases that exceed inflation.

The new law also reduced the out-of-pocket prescription drug costs for Medicare Part D beneficiaries, and to help pay for this change in benefit design, the law imposes a new discount program starting in 2025, in which manufacturers pay specified discounts on Medicare Part D utilization of their drugs as a condition of selling such drugs in the Medicare Part D program.

The Inflation Reduction Act includes certain exemptions for small biotech drug manufacturers, including Incyte.

These exemptions apply on a drug-specific basis, and qualifying drugs will be exempt from possible negotiation through 2028 and subject to reduced discounts that will be phased-in over a number of years under the new Part D benefit.

These reforms may affect future investments in our drug development, should the reforms affect our risk-benefit analysis of investing in a drug candidate.

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.

- the label and promotional claims allowed by the FDA;

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 and measures to address the COVID-19 pandemic, as well as the effects resulting from the Russian invasion of Ukraine and related sanctions and other actions, on any or all of these countries is uncertain and unpredictable and potential disruption is possible.

Business disruptions could seriously harm our operations, future revenues and financial condition and increase our costs and expenses.

Our operations, and those of our CROs, suppliers, and other contractors and consultants, could be subject to geopolitical events, natural disasters, power and other infrastructure failures or shortages, public health pandemics or epidemics, and other natural or man-made disasters or business interruptions.

In addition, geopolitical and other events, such as the Russian invasion of Ukraine, could lead to sanctions, embargoes, supply shortages, regional instability, geopolitical shifts, cyberattacks, other retaliatory actions, and adverse effects on macroeconomic conditions, currency exchange rates, and financial markets, which could adversely impact our operations and financial results, as well as those of third parties with whom we conduct business.

The occurrence of any of these business disruptions could seriously harm our operations, future revenues and financial condition and increase our costs and expenses.

We have engaged CROs to conduct clinical trials outside the United States, including a limited number of trials in Ukraine and Russia.

We may not be able to complete any additional dosing or follow-up visits of patients in Ukraine and Russia who are participating in these clinical trials.

We may also be unable to ship additional clinical drug and other supplies necessary to complete the clinical trials in Ukraine and Russia.

Although the impact of Russia’s invasion is highly unpredictable, certain clinical trial activities have already been changed or suspended, and may continue to be changed, suspended or terminated, which could potentially increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.

For example, beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures for tax purposes in the year incurred and instead requires taxpayers to capitalize and subsequently amortize such expenditures over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States.

If the requirement to amortize research and development expenditures is not repealed or otherwise modified, it will continue to have an adverse effect on our tax liability, and the amount of that effect could be material.

As another example, in August 2022, the Inflation Reduction Act of 2022 was enacted, which, among other things, includes a new 15% alternative minimum tax on the adjusted financial statement income of certain large corporations for tax years beginning after December 31, 2022.

Furthermore, the enactment of some or all of the recommendations set forth or that may be forthcoming in the Organization for Economic Co-Operation and Development (OECD) project on “Base Erosion and Profit Shifting” (commonly known as BEPS 2.0) by tax authorities and economic blocs in the countries in which we operate, could unfavorably impact our effective tax rate.

Broadly speaking, BEPS 2.0 would make fundamental changes to the international tax system, including with respect to the entitlement to tax global corporate profits and minimum global tax rates.

For example, in December 2022, the EU member states agreed to implement in their domestic tax laws a 15% global minimum tax on the profits of large multinational enterprises with a target effective date for fiscal years beginning on or after December 31, 2023.

The United Kingdom has enacted legislation similar to the GDPR, the UK GDPR, which provides for potential fines of up to the greater of £17.5 million or 4% of the annual global revenue.

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

” If government and other third-party payors refuse to provide coverage and reimbursement with respect to our products,

These regulations continue to apply after product marketing approval,

In any event, the commercial potential of our current products and any future

For example, in August 2019, Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company, announced that the FDA had approved INREBIC (fedratinib) for the treatment of myelofibrosis.

See “—Other Risks Relating to our Business— 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” for a description of risks relating to this type of competition.

The extent to which the COVID-19 pandemic and the measures taken to limit COVID-19’s spread impact our operations and those of our suppliers, collaborators, service providers and healthcare organizations

| | ● | 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. Having a significant portion of our employees work from home can strain our information technology infrastructure, which may affect our ability to operate effectively, may make us more susceptible to communications disruptions, and expose us to greater cybersecurity risks. |

affect our financial results and growth prospects.

If any of our collaborators or licensees terminates its agreement with us, or

a licensor’s ability to continue to perform its obligations under an in-license agreement.

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.

We currently hire

product liability claims,” the conduct of clinical trials of medical products that are intended for human use entails an inherent risk of product liability.

common stock or incur further indebtedness.

In recent periods, similar types of investments and money market funds have experienced losses in value or liquidity issues that differ from their historical pattern.

The Administration and Congress are considering significant changes to existing U.S. tax law, including an increase in the corporate tax rate and the effective tax rate on foreign earnings.

These changes could substantially increase U.S. taxation of our operations.

In addition, the Organisation for Economic Co-Operation and Development (OECD) in October 2021 announced an agreement on an outline for new tax rules that would align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries.

business.” could affect potential future royalty and milestone and contract revenue.

to protect our products or all of the potential uses of our products, or otherwise prevent others from developing competing products or technologies.

litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which could harm our business and operations.

A discussion of our financial performance for the year ended December 31, [removed: 2021] [added: 2022] as compared to the year ended December 31, [removed: 2020] [added: 2021] 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: 2020] [added: 2021] compared to the year ended December 31, [removed: 2019] [added: 2020] 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: 2020,] [added: 2021,] filed with the SEC on February [removed: 9, 2021,] [added: 8, 2022,] which is available free of charge on the SEC’s website at [removed: _www.sec.gov_] [added: *www.sec.gov*] and our Investor Relations website at [removed: _investor.incyte.com/financial-information/annual-reports_.][added: *investor.incyte.com/financial-information/annual-reports*.]

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

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

As a result, it is not currently possible to ascertain [removed: or predict] the [removed: overall long-term] [added: potential long term] impact of the COVID-19 pandemic on our business.

To date, [added: 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 [removed: measures,] [added: 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.

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

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

License [removed: Agreements and] [added: Agreements,] Business [removed: Relationships][added: Relationships and Acquisitions]

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, [removed: 2021.][added: 2022.]

Under the terms of [removed: this] [added: the] agreement, we [added: recognized an upfront payment and] are eligible to receive [removed: up to an] additional [removed: $45.0 million in] potential [removed: development and] [added: development,] regulatory [added: and commercial] milestones and [removed: up to $37.5 million in potential] [added: royalties on net] sales [removed: milestones from InnoCare.][added: of the licensed product in Japan.]

[removed: _Product Revenues_][added: *Product Revenues*]

As of December 31, [removed: 2021,] [added: 2022,] a 5% change in our sales allowance and accruals would have had an approximate [removed: $29.2] [added: $50.1] million impact on our income before taxes.

[removed: _Customer Credits:_] [added: *Customer Credits:*] Our customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts.

[removed: _Rebates] [added: *Rebates] and [removed: Discounts:_] [added: Discounts:*] We accrue rebates for mandated discounts under the Medicaid Drug Rebate Program in the United States and mandated discounts in Europe in markets where government-sponsored healthcare systems are the primary payers for healthcare.

Our estimates for expected utilization of [added: commercial insurance] rebates are based on data received from our customers.

[removed: _Chargebacks:_] [added: *Chargebacks:*] Chargebacks are discounts that occur when certain [added: indirect] contracted customers purchase directly from our wholesalers at a discounted price.

If actual future chargebacks vary from these estimates, we may need to adjust prior [added: period accruals, which would affect revenue in the period of adjustment.]

[removed: _Medicare] [added: *Medicare] Part D Coverage [removed: Gap:_] [added: Gap:*] Medicare Part D prescription drug benefit mandates manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients.

[removed: _Co-payment Assistance:_] [added: *Co-payment Assistance:*] Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance.

[removed: _Product] [added: *Product] Royalty [removed: Revenues_][added: Revenues*]

[removed: _Milestone] [added: *Milestone] and Contract [removed: Revenues_][added: Revenues*]

For the years ending December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] our Black-Scholes assumptions [removed: have remained unchanged with] [added: included] a weighted-average stock price volatility of [added: 36% in 2022 and] 39% [removed: to 40%,] [added: in 2021,] average expected option life of approximately five years and an estimated annualized forfeiture rate of 5%.

The fair value of RSUs that are subject to cliff vesting are recognized as compensation expense over the requisite service period using the straight-line attribution method, and the fair value of RSUs that are subject to graded vesting are recognized as compensation expense over the requisite service [added: period using the accelerated attribution method.]

The assumptions used to determine the fair value of the acquisition-related contingent consideration include projected future net revenues of ICLUSIG and a discount [removed: rate which,] [added: rate, which] require significant judgement and are analyzed on a quarterly basis.

The valuation inputs utilized to estimate the fair value of the contingent consideration as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] included a discount rate of 10% and updated projections of future net revenues of ICLUSIG in the European Union and other countries for the approved third line treatment.

Years Ended December 31, [removed: 2021] [added: 2022] and [removed: 2020][added: 2021]

We recorded net income for the [removed: year] [added: years] ended December 31, [added: 2022 and] 2021 of [removed: $948.6] [added: $340.7] million and [removed: net loss for the year ended December 31, 2020 of $295.7 million.][added: $948.6 million, respectively.]

On a per share basis, basic [added: net income was $1.53] and diluted net [removed: loss] [added: income] was [removed: $1.36] [added: $1.52] for the year ended December 31, [removed: 2020.][added: 2022.]

| [removed: ​] | | [added: |] For the Year [removed: Ended,] [added: Ended, December 31,] | | | | | | [added: | | |]

| [removed: ​] [added: December 31:] | | [removed: December 31,] | | | | | | [added: | | | |]

| [removed: ​] | | [added: |] (in millions) | | | | | | [added: | | |]

| JAKAFI revenues, net | [removed: ​] | [added: |] $ | [removed: 2,134.5] [added: 2,409.2] | [removed: ​] | [added: | | |] $ | [removed: 1,937.8] [added: 2,134.5] | [removed: ​] |

| ICLUSIG revenues, net | [removed: ​] | [removed: ​] | [removed: 109.4] [added: 105.8] | [removed: ​] | [removed: ​] | [removed: 105.0] | [removed: ​] | [added: | 109.4 | | |]

| PEMAZYRE revenues, net | [removed: ​] | [removed: ​] | [removed: 68.5] [added: 83.5] | [removed: ​] | [removed: ​] | [removed: 25.9] | [removed: ​] | [added: | 68.5 | | |]

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

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

| Total product revenues, net | [removed: ​] | [removed: ​] | [removed: 2,322.0] [added: 2,746.9] | [removed: ​] | [removed: ​] | [removed: 2,068.7] | [removed: ​] | [added: | 2,322.0 | | |]

| JAKAVI product royalty revenues | [removed: ​] | [removed: ​] | [removed: 338.0] [added: 331.6] | [removed: ​] | [removed: ​] | [removed: 277.9] | [removed: ​] | [added: | 338.0 | | |]

| OLUMIANT product royalty revenues | [removed: ​] | [removed: ​] | [removed: 220.9] [added: 134.5] | [removed: ​] | [removed: ​] | [removed: 110.9] | [removed: ​] | [added: | 220.9 | | |]

Our revenues depend on continued sales of our products, and we depend substantially on product revenues from JAKAFI.

We must develop and commercialize new products to achieve revenue growth and to offset revenue losses from when products lose their exclusivity or when competing products are launched.

For additional information, including information on the expirations of patents for various products, see Part I, Item 1 of this report, “Business—Patents and Other Intellectual Property” and “Business—Competition.” We devote substantial resources to research and development activities and to acquire rights to new product candidates and technologies, but successful product development in the biopharmaceutical industry is highly uncertain.

Our product revenues also face challenges from economic conditions and drug pricing initiatives driven by governments and private payors.

See Part I, Item 1A of this report, “Risk Factors” for a further discussion of certain factors that could impact our future product revenues.

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.

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.

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.

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.

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).

Under the terms of the agreement, we paid an upfront payment of $70 million, and former Villaris stockholders will be eligible for up to $310.0 million upon achievement of certain development and regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of the product.

CMS Aesthetics Limited

In December 2022, we entered into a Collaboration and License Agreement with CMS Aesthetics Limited, a subsidiary of China Medical System Holdings Limited, for the development and commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK inhibitor ruxolitinib, for the treatment of autoimmune and inflammatory dermatologic diseases in Greater China and Southeast Asia.

Under the terms of the agreement, CMS paid us an upfront payment of $30.0 million upon our transfer of the functional intellectual property related to ruxolitinib cream to CMS, and we are eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.

CMS received an exclusive license to develop and commercialize and a non-exclusive license to manufacture ruxolitinib cream, and potentially other future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, for patients in mainland China, Hong Kong, Macau, Taiwan and Southeast Asia.

In the fourth quarter of 2021 and fiscal year 2022 for non-covered patients of OPZELURA, we offered a full buy-down program as we were in the process of obtaining commercial insurance coverage for OPZELURA.

During 2022, we contracted with the three largest group purchasing organizations to obtain coverage for OPZELURA.

All full buy-down programs for OPZELURA ended effective January 31, 2023.

In December 2019, coronavirus disease of 2019, or COVID-19, was first reported in Wuhan, China.

In March 2020, the World Health Organization declared COVID-19 a pandemic and certain governments, including the State of Delaware where our primary offices and laboratory spaces are located, enacted stay-at-home orders and sweeping restrictions to travel and business activity were initiated by corporations and governments.

We took aggressive, proactive actions early on to protect the health of our employees, and their families, including voluntarily requiring almost all personnel across our global enterprise to work remotely and restricting access to our sites to personnel who were required to perform critical business continuity activities.

In May 2020, we initiated a return to full laboratory work at our facilities in Wilmington, Delaware, as well as a gradual return to office-based working, where allowed under local guidelines, at our offices in North America, Europe and Asia.

However, the spread of the Omicron variant beginning late in 2021 has led to renewed restrictions in some jurisdictions and a voluntary reduction in travel and in-person meetings even where restrictions were not imposed.

While we currently believe we are well-positioned to function in a hybrid on-site and virtual or remote fashion, the extent of the COVID-19 Pandemic’s effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, protective measures, and the reimposition of protective measures, implemented by governmental authorities or by us to protect our employees, and effects of the pandemic and such protective measures on our suppliers, collaborators, services providers and healthcare organizations serving patients, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.

Until our return to full laboratory work, our discovery laboratories were staffed by essential personnel, and hence certain discovery programs experienced delays.

In March 2021, PEMAZYRE (pemigatinib) was approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with unresectable biliary tract cancer with an FGFR2 fusion gene, worsening after cancer chemotherapy.

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

PEMAZYRE was approved by the Food and Drug Administration (FDA) in April 2020 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.

We have retained all rights to PEMAZYRE globally, other than those granted to Innovent Biologics, Inc. to develop and commercialize pemigatinib in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

In August 2021, under our collaboration and license agreement with MorphoSys AG, the European Commission 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.

MONJUVI (tafasitamab-cxix) was approved by the FDA in July 2020 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.

We have rights to co-commercialize tafasitamab in the United States with MorphoSys, and we have exclusive development and commercialization rights outside of the United States.

In September 2021, the FDA approved JAKAFI for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

We have retained all development and commercialization rights to JAKAFI in the United States and are eligible to receive development and sales milestones as

well as royalties from product sales outside the United States.

In September 2021, the FDA approved OPZELURA (ruxolitinib) cream, a novel cream formulation of our selective JAK1/JAK2 inhibitor ruxolitinib, for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

In June 2021, we recognized a $10.0 million milestone for approval of PEMAZYRE in Taiwan, which was recorded in milestone and contract revenues.

InnoCare

In August 2021, we entered into a Collaboration and License Agreement with a subsidiary of InnoCare Pharma Limited.

Under the terms of this agreement, InnoCare’s subsidiary received development and exclusive commercialization rights to tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

In September 2021, we recognized an upfront payment under this agreement of $35.0 million upon our transfer of technology related to the licensed product candidate to InnoCare which was recorded in milestone and contract revenues.

We are also eligible to receive tiered royalties from the low to mid-twenties on future product sales resulting from the collaboration.

Syndax

In September 2021, we entered into a Collaboration and License Agreement with Syndax covering the worldwide development and commercialization of SNDX-6352 (axatilimab), Syndax’s anti-CSF-1R monoclonal antibody.

The Agreement became effective in December 2021 with the expiration of the initial waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Under the terms of this agreement, we received exclusive commercialization rights outside of the United States, and Syndax has co-commercialization rights in the United States with respect to axatilimab.

We paid Syndax an upfront payment of $117.0 million upon effectiveness of the agreement.

Syndax is eligible to receive up to $220.0 million in future contingent development and regulatory milestones and $230.0 million in sales milestones as well as tiered royalties ranging in the mid-teens on net sales in Europe and Japan and low double digit percentage on net sales in the rest of the world outside of the United States.

In December 2021, we recognized a $50.0 million sales milestone for Lilly achieving annual net sales of a licensed product of $1.0 billion.

Additional information regarding our collaboration agreements, including their financial and accounting impact on our business and results of operations, can be found in Note 6 of Notes to the Consolidated Financial Statements.

period accruals, which would affect revenue in the period of adjustment.

period using the accelerated attribution method.

| ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |

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

| ​ | | 2021 | | | 2020 | | |

| | | | | | | | |

| ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |

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

As of December 31, [removed: 2021,] [added: 2022,] marketable securities were [removed: $290.8] [added: $287.5] 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: 2021,] [added: 2022,] the decline in fair value would not be material.

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

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

The other therapeutic area is Inflammation and Autoimmunity (IAI), which includes our [removed: newly established] Dermatology commercial franchise.

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

It was approved by the U.S. Food and Drug Administration (FDA) in November 2011 for the treatment of adults with intermediate or high-risk myelofibrosis [removed: (MF),] [added: (MF);] in December 2014 for the treatment of adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of [removed: hydroxyurea,] [added: hydroxyurea;] in May 2019 for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and [removed: older] [added: older;] and in September 2021 for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

[removed: Myelofibrosis] [added: MF] and [removed: polycythemia vera] [added: PV] are both myeloproliferative neoplasms (MPNs), a type of rare blood cancer, and GVHD is an adverse immune response to an allogeneic hematopoietic stem cell transplant (HSCT).

[removed: _Myelofibrosis._] [added: *Myelofibrosis.*] MF is a rare, life-threatening condition.

In September 2016, we announced that JAKAFI had been included as a recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for myelofibrosis, underscoring the important and [removed: long-term] [added: long term] clinical benefits seen in patients treated with JAKAFI.

[removed: _Polycythemia Vera._] [added: *Polycythemia Vera.*] PV is a myeloproliferative neoplasm typically characterized by elevated hematocrit, the volume percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count.

[removed: _Graft-versus-host disease._] [added: *Graft-versus-host disease.*] GVHD is a condition that can occur after an allogeneic HSCT (the transfer of genetically dissimilar stem cells or tissue).

The most common [removed: nonhematologic] [added: non-hematologic] adverse reactions (incidence ≥ 20%) were infections (pathogen not specified) and viral infection.

We hold patents that cover the composition of matter and use of [removed: ruxolitinib, which patents, including applicable extensions, expire in mid-2028.][added: ruxolitinib.]

In March 2021, PEMAZYRE was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with unresectable biliary tract cancer (BTC) with an FGFR2 fusion gene, worsening after [added: cancer chemotherapy.]

Additional Phase II trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) and INCB00928 (ALK2) in patients with MF are [removed: in preparation,] [added: ongoing,] and additional discovery and development initiatives are also ongoing within the LIMBER program, which are evaluating [removed: both] internally-discovered compounds, [removed: including itacitinib (JAK1),] and candidates from collaboration partners.

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

Additional trials of axatilimab are planned in patients with chronic GVHD, including a Phase II trial in combination with [removed: a JAK inhibitor] [added: ruxolitinib] in patients with [removed: steroid-refractory] [added: newly-diagnosed] cGVHD.

A placebo-controlled Phase III trial (inMIND) of tafasitamab added to lenalidomide plus rituximab (R2) in patients with relapsed or refractory follicular or marginal zone lymphomas is [removed: ongoing, as is a proof-of-concept study (topMIND) evaluating tafasitamab in combination with parsaclisib (PI3Kδ) in patients with relapsed or refractory B-cell malignancies.][added: ongoing.]

[removed: We are also preparing to initiate a] [added: A] proof-of-concept study of tafasitamab, lenalidomide and plamotamab in patients with r/r [removed: DLBCL.][added: DLBCL is also ongoing.]

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

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

In October 2021, we announced the FDA acceptance of [removed: a] [added: 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 [removed: 2] [added: II] studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory [removed: NHLs] [added: 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 [removed: NHL.][added: non-Hodgkin lymphoma.]

[removed: A Phase II trial of parsaclisib in patients with] [added: Parsaclisib is being evaluated as a treatment for] autoimmune hemolytic anemia (AIHA), a rare red blood cell [removed: disorder, is ongoing.][added: disorder.]

In June 2021, data from [removed: the] [added: a] Phase II trial were presented at EHA.

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

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

In July 2021, we announced that the FDA issued a complete response letter (CRL) for the BLA of retifanlimab for the treatment of [removed: squamous cell carcinoma of the anal canal (SCAC).][added: SCAC.]

In October 2021, we announced that we withdrew the [removed: Marketing Authorization Application (MAA)] [added: MAA] seeking approval of retifanlimab in SCAC.

The Phase III 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 [removed: (NSCLC), and in October 2020, our collaboration partner Zai Lab announced dosing of the first patient in China.][added: (NSCLC).]

| | | [added: |] Indication and status | | [added: |]

| [removed: Once-a-day ruxolitinib] [added: ruxolitinib XR (QD)] (JAK1/JAK2) | [added: | |] Myelofibrosis, polycythemia vera and GVHD: [removed: clinical pharmacology studies] [added: NDA under review] | | |

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

| ruxolitinib + [removed: INCB57643 (JAK1/JAK2] [added: INCB57643 (JAK1/JAK2] + BET) | [added: | |] Myelofibrosis: Phase II [removed: in preparation] | | |

| ruxolitinib + [removed: INCB00928 (JAK1/JAK2] [added: zilurgisertib (JAK1/JAK2] + ALK2) | [added: | |] Myelofibrosis: Phase II [removed: in preparation] | | |

| ruxolitinib + [removed: CK08041] [added: CK08041] (JAK1/JAK2 + CB-Tregs) | [added: | |] Myelofibrosis: [removed: PoC in preparation] [added: Phase I (LIMBER-TREG108)] | | |

| axatilimab (anti-CSF-1R)2 | [added: | |] Chronic GVHD: Pivotal Phase II (third-line plus therapy) (AGAVE-201) | | |

| tafasitamab [removed: (CD19)3] [added: (CD19)3] | [added: | |] 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) [removed: r/r B-cell malignancies: PoC with parsaclisib (PI3Kδ) (topMIND) r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation4 ​] | | |

| pemigatinib (FGFR1/2/3) | [removed: CCA: Phase III (FIGHT-302)] [added: | |] Myeloid/lymphoid neoplasms (MLN): Phase II [removed: (FIGHT-203)] [added: (FIGHT-203); approved by FDA CCA: Phase III (FIGHT-302)] Glioblastoma: Phase II [removed: in preparation] [added: (FIGHT-209)] NSCLC: Phase II [removed: in preparation ​] [added: (FIGHT-210)] | | |

| parsaclisib (PI3Kδ) | [removed: Autoimmune] [added: | | Warm autoimmune] hemolytic anemia: Phase III (PATHWAY) [removed: ​] | | |

These patents, including applicable extensions, currently expire in late-2028.

We have been granted pediatric exclusivity which adds six months to the expiration for all ruxolitinib patents presently listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

In August 2022, PEMAZYRE was approved by the FDA as the first and only targeted treatment for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers.

Ruxolitinib

Axatilimab

In May 2022, Syndax announced that axatilimab was 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.

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.

Oral PD-L1

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

Tumor shrinkage was observed for both oral PD-L1 inhibitors and both were generally well tolerated.

We plan to evaluate INCB99280 in Phase II as monotherapy and in combination with other antitumor agents.

Further dose escalation and dose expansion trials are ongoing with INCB99318.

In November 2022, (i) updated safety and preliminary efficacy data for INCB99280 and INCB99318 was presented at the Society for Immunotherapy of Cancer, and (ii) we and Mirati Therapeutics, Inc. announced a clinical trial collaboration and supply agreement to investigate the combination of INCB99280 and adagrasib, a KRASG12C selective inhibitor, in patients with KRASG12C-mutated solid tumors.

| | | | | | |

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

| ruxolitinib + axatilimab (JAK1/JAK2 + anti-CSF-1R) | | | Chronic GVHD (newly diagnosed): Phase I/II in preparation | | |

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

| INCB99318 (Oral PD-L1) | | | Solid tumors: Phase I | | |

INCB123667 (CDK2)

In the cell cycle, the serine threonine kinase, CDK2, regulates the transition from the G1 phase (cell growth) to the S-phase (DNA replication).

INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models, in vivo.

In July 2022, we initiated a Phase I dose-escalation and dose-expansion study evaluating INCB123667 in adults with selected advanced or metastatic solid tumors.

INCA32459 (LAG-3xPD-1)

In collaboration with Merus N.V. we have developed INCA32459, a novel LAG3xPD-1 bispecific antibody that is currently being evaluated in clinical studies.

INCA33989 (mCALR)

In December 2022, new research detailing the development and mechanism of action of INCA033989, an Incyte-discovered, investigational novel anti-mutant calreticulin (CALR)-targeted monoclonal antibody, was featured in the Plenary Scientific Session at the 64th American Society of Hematology (ASH) Annual Meeting.

INCA033989 binds with high affinity to mutant CALR and inhibits oncogenesis, the process of cells becoming cancerous, in cells expressing this oncoprotein.

CALR mutations are responsible for disease development in approximately 25-35% of patients with MF and ET.

INCA33989 is currently expected to enter clinical studies in 2023.

| | | | | | |

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

| Bispecific antibodies | | | INCA32459 (LAG-3xPD-1)2 | | |

2.Development collaboration with Merus

*Atopic Dermatitis*.

*Vitiligo.* In July 2022, we announced that the FDA approved OPZELURA for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

OPZELURA was approved for continuous use and no limits to duration as a treatment for nonsegmental vitiligo.

The approval of OPZELURA in vitiligo was based on two randomized, double-blind, vehicle-controlled Phase III studies (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of OPZELURA in adolescents and adults with nonsegmental vitiligo.

At Week 52, approximately 50% of patients achieved F-VASI75.

The most common (>1%) treatment-emergent adverse reactions in patients treated with OPZELURA were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema and pyrexia.

cancer chemotherapy.

We have retained all rights to PEMAZYRE globally, other than those granted to Innovent Biologics, Inc. to develop and commercialize pemigatinib in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

Ruxolitinib and itacitinib

Itacitinib is a selective JAK1 inhibitor being evaluated in GRAVITAS-309, a Phase II/III trial of itacitinib in patients with steroid-naïve chronic GVHD.

The FDA has granted itacitinib orphan drug status for GVHD.

We have an ongoing EMA submission under review for MZL.

| | | | |

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

| itacitinib (JAK1) | Treatment-naïve chronic GVHD: Phase II/III (GRAVITAS-309) | | |

1.

2.

3.

4.

Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab.

5.

| | | ​ |

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

We are currently evaluating ruxolitinib cream in a Phase III trial, TRuE-AD3, in pediatric atopic dermatitis patients ages ≥2 years to < 12 years.

A Phase III trial evaluating ruxolitinib cream in chronic hand eczema is in preparation.

In May 2021, we announced positive topline results from the Phase III TRuE-V program evaluating ruxolitinib cream as a treatment for adolescent and adult patients with vitiligo.

Both TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints, including patient reported outcomes.

The overall efficacy and safety profile of ruxolitinib cream was consistent with previously reported Phase II data, and no new safety signals were observed.

In October 2021, data from the Week 24 analysis of the Phase III TRuE-V program were presented at the European Academy of Dermatology and Venereology Congress (EADV).

The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data.

In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions.

Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported.

In December 2021, we announced that the U.S. FDA accepted for Priority Review the sNDA for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥ 12 years) with vitiligo.

​

An sNDA for baricitinib has been submitted by

Regulatory applications for baricitinib as a treatment for alopecia areata have been submitted in the U.S., Europe and Japan.

In November 2020, we and Lilly announced that the FDA issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

In December 2020, we and Lilly announced that data from ACTT-2 supportive of the EUA were published in the New England Journal of Medicine.

In July 2021, we and Lilly announced that the FDA broadened the EUA for baricitinib to allow for treatment with or without remdesivir.

Capmatinib is being evaluated

| | |

| --- | --- |

technologies.

Zai Lab

Under the terms of this agreement, Zai Lab’s subsidiary received development and exclusive commercialization rights to retifanlimab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

We retained an option to assist in the promotion of retifanlimab in Zai Lab’s licensed territories.

[removed: FORM 10-K][added: FORM 10-K]

| (mark one) | [removed: ​] | [added: | | | |]

| [removed: ☒] [added: x] | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the fiscal year [removed: ended December] [added: ended December] 31, [removed: 2021][added: 2022 or]

| [removed: ☐] [added: o] | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

Commission File [removed: Number: 001-12400][added: Number: 001-12400]

| [removed: Delaware] (State of other jurisdiction of incorporation or organization) | [removed: 94-3136539] [added: | |] (IRS Employer Identification No.) | [added: | |]

| Title of each class | [added: | | | | |] Trading Symbol(s) | [added: | | | | |] Name of exchange on which registered | [added: | |]

| Common Stock, $.001 par value per share | [added: | | | | |] INCY | [added: | | | | |] The Nasdaq Stock Market LLC | [added: | |]

Yes [removed: ☒] [added: x] No [removed: ☐][added: o]

Yes [removed: ☐] [added: o] No [removed: ☒][added: x]

| Large accelerated filer [removed: ☒] | [added: | | x | | |] Accelerated filer [removed: ☐] | [added: | | o | | |] Non-accelerated filer [removed: ☐ ​] | [added: | | o | | |] Smaller reporting company [removed: ☐ ​] [added: | | | o | | |] Emerging growth company [removed: ☐] | [added: | | o | | |]

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: 2021)] [added: 2022)] was approximately [removed: $16.0] [added: $14.2] billion.

As of [removed: February 1, 2022] [added: January 31, 2023] there were [removed: 221,325,189] [added: 222,965,018] 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: 2022] [added: 2023] Annual Meeting of Stockholders to be held on June [removed: 15, 2022.][added: 14, 2023.]

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

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

| [removed: PART I] [added: [PART I](#if009c8ccc24c44da8511b38de3b79441_16)] | [removed: ​] | [removed: ​] | [added: | | | | | |]

| [Item [removed: 1.](#Item_1_Business)] [added: 1.](#if009c8ccc24c44da8511b38de3b79441_19)] | [removed: [Business](#Item_1_Business)] | [removed: 7] | [added: [Business](#if009c8ccc24c44da8511b38de3b79441_19) | | | [7](#if009c8ccc24c44da8511b38de3b79441_19) | | |]

| [Item [removed: 1A.](#Item_1A_Risk_Factors)] [added: 1A.](#if009c8ccc24c44da8511b38de3b79441_22)] | [added: | |] [Risk [removed: Factors](#Item_1A_Risk_Factors)] [added: Factors](#if009c8ccc24c44da8511b38de3b79441_22)] | [removed: 36] | [added: | [35](#if009c8ccc24c44da8511b38de3b79441_22) | | |]

| [Item [removed: 1B.](#Item_1B_Unresolved_Staff_Comments)] [added: 1B.](#if009c8ccc24c44da8511b38de3b79441_25)] | [added: | |] [Unresolved Staff [removed: Comments](#Item_1B_Unresolved_Staff_Comments)] [added: Comments](#if009c8ccc24c44da8511b38de3b79441_25)] | [removed: 63] | [added: | [62](#if009c8ccc24c44da8511b38de3b79441_25) | | |]

| [Item [removed: 2.](#Item_2_Properties)] [added: 2.](#if009c8ccc24c44da8511b38de3b79441_28)] | [removed: [Properties](#Item_2_Properties)] | [removed: 63] | [added: [Properties](#if009c8ccc24c44da8511b38de3b79441_28) | | | [62](#if009c8ccc24c44da8511b38de3b79441_28) | | |]

| [Item [removed: 3.](#Item_3_Legal_Proceedings)] [added: 3.](#if009c8ccc24c44da8511b38de3b79441_31)] | [added: | |] [Legal [removed: Proceedings](#Item_3_Legal_Proceedings)] [added: Proceedings](#if009c8ccc24c44da8511b38de3b79441_31)] | [removed: 64] | [added: | [62](#if009c8ccc24c44da8511b38de3b79441_31) | | |]

| [Item [removed: 4.](#Item_4_Mine_Safety)] [added: 4.](#if009c8ccc24c44da8511b38de3b79441_34)] | [added: | |] [Mine Safety [removed: Disclosures](#Item_4_Mine_Safety)] [added: Disclosures](#if009c8ccc24c44da8511b38de3b79441_34)] | [removed: 64] | [added: | [63](#if009c8ccc24c44da8511b38de3b79441_34) | | |]

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

| [Item [removed: 5.](#Item_5_Market_for_Registrant)] [added: 5.](#if009c8ccc24c44da8511b38de3b79441_43)] | [added: | |] [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#Item_5_Market_for_Registrant)] [added: Securities](#if009c8ccc24c44da8511b38de3b79441_43)] | [removed: 66] | [added: | [65](#if009c8ccc24c44da8511b38de3b79441_43) | | |]

| [Item [removed: 7.](#Item_7_Management_Discussion)] [added: 7.](#if009c8ccc24c44da8511b38de3b79441_49)] | [added: | |] [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#Item_7_Management_Discussion)] [added: Operations](#if009c8ccc24c44da8511b38de3b79441_49)] | [removed: 66] | [added: | [65](#if009c8ccc24c44da8511b38de3b79441_49) | | |]

| [Item [removed: 7A.](#Item_7A_Quantitative)] [added: 7A.](#if009c8ccc24c44da8511b38de3b79441_73)] | [added: | |] [Quantitative and Qualitative Disclosures About Market [removed: Risk](#Item_7A_Quantitative)] [added: Risk](#if009c8ccc24c44da8511b38de3b79441_73)] | [removed: 77] | [added: | [77](#if009c8ccc24c44da8511b38de3b79441_73) | | |]

| [Item [removed: 8.](#Item_8_Financial_Statements)] [added: 8.](#if009c8ccc24c44da8511b38de3b79441_76)] | [added: | |] [Financial Statements and Supplementary [removed: Data](#Item_8_Financial_Statements)] [added: Data](#if009c8ccc24c44da8511b38de3b79441_76)] | [removed: 78] | [added: | [78](#if009c8ccc24c44da8511b38de3b79441_76) | | |]

| [Item [removed: 9.](#Item_9_Changes_in_and_Disagreements)] [added: 9.](#if009c8ccc24c44da8511b38de3b79441_157)] | [added: | |] [Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#Item_9_Changes_in_and_Disagreements)] [added: Disclosure](#if009c8ccc24c44da8511b38de3b79441_157)] | [removed: 119] | [added: | [117](#if009c8ccc24c44da8511b38de3b79441_157) | | |]

| [Item [removed: 9A.](#Item_9A_Controls_and_Procedures)] [added: 9A.](#if009c8ccc24c44da8511b38de3b79441_160)] | [added: | |] [Controls and [removed: Procedures](#Item_9A_Controls_and_Procedures)] [added: Procedures](#if009c8ccc24c44da8511b38de3b79441_160)] | [removed: 119] | [added: | [117](#if009c8ccc24c44da8511b38de3b79441_160) | | |]

| [Item [removed: 9B.](#Item_9B_Other_Information)] [added: 9B.](#if009c8ccc24c44da8511b38de3b79441_163)] | [added: | |] [Other [removed: Information](#Item_9B_Other_Information)] [added: Information](#if009c8ccc24c44da8511b38de3b79441_163)] | [removed: 122] | [added: | [120](#if009c8ccc24c44da8511b38de3b79441_163) | | |]

| [Item [removed: 10.](#Item_10_Directors_Executive_Officers)] [added: 10.](#if009c8ccc24c44da8511b38de3b79441_169)] | [added: | |] [Directors, Executive Officers and Corporate [removed: Governance](#Item_10_Directors_Executive_Officers)] [added: Governance](#if009c8ccc24c44da8511b38de3b79441_169)] | [removed: 122] | [added: | [120](#if009c8ccc24c44da8511b38de3b79441_169) | | |]

| [Item [removed: 11.](#Item_11_Executive_Compensation)] [added: 11.](#if009c8ccc24c44da8511b38de3b79441_172)] | [added: | |] [Executive [removed: Compensation](#Item_11_Executive_Compensation)] [added: Compensation](#if009c8ccc24c44da8511b38de3b79441_172)] | [removed: 122] | [added: | [120](#if009c8ccc24c44da8511b38de3b79441_172) | | |]

| [Item [removed: 12.](#Item_12_Security_Ownership_of_Certain)] [added: 12.](#if009c8ccc24c44da8511b38de3b79441_175)] | [added: | |] [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#Item_12_Security_Ownership_of_Certain)] [added: Matters](#if009c8ccc24c44da8511b38de3b79441_175)] | [removed: 122] | [added: | [120](#if009c8ccc24c44da8511b38de3b79441_175) | | |]

| [Item [removed: 13.](#Item_13_Certain_Relationships)] [added: 13.](#if009c8ccc24c44da8511b38de3b79441_178)] | [added: | |] [Certain Relationships and Related Transactions, and Director [removed: Independence](#Item_13_Certain_Relationships)] [added: Independence](#if009c8ccc24c44da8511b38de3b79441_178)] | [removed: 123] | [added: | [121](#if009c8ccc24c44da8511b38de3b79441_178) | | |]

| [Item [removed: 14.](#Item_14_Principal_Accountant_Fees)] [added: 14.](#if009c8ccc24c44da8511b38de3b79441_181)] | [added: | |] [Principal Accountant Fees and [removed: Services](#Item_14_Principal_Accountant_Fees)] [added: Services](#if009c8ccc24c44da8511b38de3b79441_181)] | [removed: 123] | [added: | [121](#if009c8ccc24c44da8511b38de3b79441_181) | | |]

| [Item [removed: 15.](#Item_15_Exhibits_Financial_Statement)] [added: 15.](#if009c8ccc24c44da8511b38de3b79441_187)] | [added: | |] [Exhibits, Financial Statement [removed: Schedules](#Item_15_Exhibits_Financial_Statement)] [added: Schedules](#if009c8ccc24c44da8511b38de3b79441_187)] | [removed: 123] | [added: | [121](#if009c8ccc24c44da8511b38de3b79441_187) | | |]

| [Item [removed: 16.](#ITEM_16)] [added: 16.](#if009c8ccc24c44da8511b38de3b79441_190)] | [added: | |] [Form 10-K [removed: Summary](#ITEM_16)] [added: Summary](#if009c8ccc24c44da8511b38de3b79441_190)] | [removed: 126] | [added: | [124](#if009c8ccc24c44da8511b38de3b79441_190) | | |]

[removed: _This] [added: *This] report contains forward-looking statements that involve risks and uncertainties.

| | | | | | |

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

| | | | | | |

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

| | | | | | |

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

| Delaware | | | 94-3136539 | | |

| 1801 Augustine Cut-Off Wilmington, DE | | | 19803 | | |

| (Address of principal executives offices) | | | (zip code) | | |

| | | | (302) 498-6700 | | |

| | | | (Registrant’s telephone number, including area code) | | |

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

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

Yes x No o

Yes x No o

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

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

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

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

Yes o No x

| | | | | | | | | |

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

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

| [Item 6.](#if009c8ccc24c44da8511b38de3b79441_46) | | | \[[Reserved](#if009c8ccc24c44da8511b38de3b79441_46)\] | | | [65](#if009c8ccc24c44da8511b38de3b79441_46) | | |

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

| [PART IV](#if009c8ccc24c44da8511b38de3b79441_184) | | | | | | | | |

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

​

| ​ | ​ |

| --- | --- |

or

| 1801 Augustine Cut-OffWilmington, DE (Address of principal executives offices) | 19803 (zip code) (302) 498-6700 (Registrant’s telephone number, including area code) |

| ​ | ​ | ​ |

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

| ​ | ​ | ​ ​​ ​ | ​ |

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

| z | ​ | ​ |

| [PART II](#PARTII_272823) | ​ | ​ |

| [Item 6.](#Item_6_Selected_Financial_Data) | \[[Reserved](#Item_6_Selected_Financial_Data)\] | 66 |

| [PART III](#PARTIII_365516) | ​ | ​ |

| [PART IV](#PARTIV_850896) | ​ | ​ |

| [SIGNATURES](#SIGNATURES) | | 127 |

| | ● | _expectations relating to the anticipated completion and GMP approval dates for our large molecule production facility;_ |

*​*

We lease approximately 112,000 square feet of office space in Chadds Ford, [removed: Pennsylvania and approximately 84,000 square feet of additional laboratory and office space in Wilmington, Delaware.][added: Pennsylvania.]

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.

Construction commenced in July 2018 and we currently expect the facility will be operational in the second half of 2022.

[removed: _Hervé Hoppenot,_] [added: *Hervé Hoppenot,*] age [removed: 62,] [added: 63,] joined Incyte as President and Chief Executive Officer and a Director, in January 2014 and was appointed Chairman of the Board in May 2015.

[removed: _Dashyant Dhanak_,] [added: *Dashyant Dhanak*,] age [removed: 61,] [added: 62,] joined Incyte in December 2018 as Executive Vice President, Chief Scientific Officer.

[removed: _Jonathan] [added: *Jonathan] E.

[removed: Dickinson_,] [added: Dickinson*,] age [removed: 54,] [added: 55,] has served as Executive Vice President and General Manager, Europe since June 2019 and joined Incyte as Senior Vice President and General Manager, Europe in June 2016.

[removed: _Barry] [added: *Barry] P.

[removed: Flannelly_,] [added: Flannelly*,] age [removed: 64,] [added: 65,] 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.

[added: He served as Vice President, Global Product Strategy and Commercial Planning of Nektar] Therapeutics, a biopharmaceutical company, from April 2011 until April 2013, and as Senior Vice President, Commercial, of Onyx Pharmaceuticals, Inc., a biopharmaceutical company, from August 2008 until January 2011.

[removed: _Vijay Iyengar_,] [added: *Vijay Iyengar*,] age [removed: 49,] [added: 50,] joined Incyte in May 2016 as Executive Vice President, Global Strategy and Corporate Development.

[removed: _Michael Morrissey_,] [added: *Michael Morrissey*,] age [removed: 58,] [added: 59,] 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: _Maria] [added: *Maria] E.

[removed: Pasquale_,] [added: Pasquale*,] age [removed: 56,] [added: 57,] joined Incyte in April 2018 as Executive Vice President and General Counsel.

[removed: _Christiana Stamoulis,_] [added: *Christiana Stamoulis,*] age [removed: 51,] [added: 52,] joined Incyte in February 2019 as Executive Vice President and Chief Financial Officer.

[removed: _Steven Stein,_] [added: *Steven Stein,*] age [removed: 55,] [added: 56,] 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.

[removed: _Paula] [added: *Paula] J.

[removed: Swain_,] [added: Swain*,] age [removed: 64,] [added: 65,] has served as Executive Vice President, Human Resources since August 2002 and joined Incyte as Senior Vice President of Human Resources in January 2002.

PART [removed: II][added: II]

He served as Vice President, Global Product Strategy and Commercial Planning of Nektar

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: 2021,] [added: 2022,] our common stock was held by [removed: 120] [added: 115] stockholders of record.

​

| [removed: ​] | [added: | |] Page | [added: | |]

| Consolidated Financial Statements of Incyte Corporation | [removed: ​] | [added: | | | |]

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

| [Consolidated Balance Sheets as of December 31, [removed: 2021 and 2020](#BALANCE_SHEETS)] [added: 202](#if009c8ccc24c44da8511b38de3b79441_82)[2](#if009c8ccc24c44da8511b38de3b79441_82) [and 202](#if009c8ccc24c44da8511b38de3b79441_82)[1](#if009c8ccc24c44da8511b38de3b79441_82)] | [removed: 82] | [added: | [81](#if009c8ccc24c44da8511b38de3b79441_82) | | |]

| [Consolidated Statements of Operations for the years ended December 31, [removed: 2021, 2020 and 2019](#STATEMENTS_OF_OPERATIONS)] [added: 202](#if009c8ccc24c44da8511b38de3b79441_85)[2](#if009c8ccc24c44da8511b38de3b79441_85)[, 202](#if009c8ccc24c44da8511b38de3b79441_85)[1](#if009c8ccc24c44da8511b38de3b79441_85) [and 20](#if009c8ccc24c44da8511b38de3b79441_85)[2](#if009c8ccc24c44da8511b38de3b79441_85)[0](#if009c8ccc24c44da8511b38de3b79441_85)] | [removed: 83] | [added: | [82](#if009c8ccc24c44da8511b38de3b79441_85) | | |]

| [Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, [removed: 2021, 2020 and 2019](#COMPREHENSIVE_LOSS)] [added: 202](#if009c8ccc24c44da8511b38de3b79441_88)[2](#if009c8ccc24c44da8511b38de3b79441_88)[, 202](#if009c8ccc24c44da8511b38de3b79441_88)[1](#if009c8ccc24c44da8511b38de3b79441_88) [and 20](#if009c8ccc24c44da8511b38de3b79441_88)[20](#if009c8ccc24c44da8511b38de3b79441_88)] | [removed: 84] | [added: | [83](#if009c8ccc24c44da8511b38de3b79441_88) | | |]

| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [removed: 2021, 2020 and 2019](#STOCKHOLDERS_DEFICIT)] [added: 202](#if009c8ccc24c44da8511b38de3b79441_91)[2](#if009c8ccc24c44da8511b38de3b79441_91)[, 202](#if009c8ccc24c44da8511b38de3b79441_91)[1](#if009c8ccc24c44da8511b38de3b79441_91) [and 20](#if009c8ccc24c44da8511b38de3b79441_91)[20](#if009c8ccc24c44da8511b38de3b79441_91)] | [removed: 85] | [added: | [84](#if009c8ccc24c44da8511b38de3b79441_91) | | |]

| [Consolidated Statements of Cash Flows for the years ended December 31, [removed: 2021, 2020 and 2019](#CASH_FLOWS)] [added: 202](#if009c8ccc24c44da8511b38de3b79441_94)[2](#if009c8ccc24c44da8511b38de3b79441_94)[, 202](#if009c8ccc24c44da8511b38de3b79441_94)[1](#if009c8ccc24c44da8511b38de3b79441_94) [and 20](#if009c8ccc24c44da8511b38de3b79441_94)[20](#if009c8ccc24c44da8511b38de3b79441_94)] | [removed: 86] | [added: | [85](#if009c8ccc24c44da8511b38de3b79441_94) | | |]

| [Notes to the Consolidated Financial [removed: Statements](#Notes_To_Financials)] [added: Statements](#if009c8ccc24c44da8511b38de3b79441_97)] | [removed: 87] | [added: | [86](#if009c8ccc24c44da8511b38de3b79441_97) | | |]

We have audited the accompanying consolidated balance sheets of Incyte Corporation (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 8, 2022] [added: 7, 2023] expressed an unqualified opinion thereon.

| [removed: _Description] [added: *Description] of the [removed: Matter_] [added: Matter*] | [removed: ​] | [added: |] 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: $136.5] [added: $192.1] million as of December 31, [removed: 2021.] [added: 2022. 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: | |]

| [removed: _How] [added: *How] We Addressed the Matter in Our [removed: Audit_] [added: Audit*] | [removed: ​] | [added: |] We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over management’s review of the allowances for rebates [removed: and discounts] owed [added: pursuant] to [removed: governmental entities.] [added: the Medicaid Drug Rebate Program in the U.S.] For example, we tested controls over management’s review of the significant assumptions, such as the utilization of these rebates [removed: and discounts] as well as controls over management’s review of the application of the government mandated calculations. To test the allowances for rebates [removed: and discounts] owed [added: pursuant] to [removed: governmental entities,] [added: the Medicaid Drug Rebate Program in the U.S.,] we performed audit procedures that included, among others, evaluating the methodologies used and testing the significant assumptions discussed above. We compared the significant assumptions used by management to historical trends, evaluated the change in the accruals from prior periods, and assessed the historical accuracy of management’s estimates against actual results. We also tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our governmental pricing specialists to assist in evaluating management’s methodology and calculations used to measure [removed: certain] [added: the] estimated [removed: rebates and discounts.] [added: rebates.] | [added: | |]

| [removed: *​*] | [removed: ​] | [added: |] Valuation of acquisition-related contingent consideration liability | [added: | |]

| [removed: _Description] [added: *Description] of the [removed: Matter_] [added: Matter*] | [removed: ​] | [added: |] 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, [removed: 2021,] [added: 2022,] the acquisition-related contingent consideration liability was [removed: $244.0] [added: $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 [removed: or] [added: and] economic conditions, and are forward-looking and inherently uncertain. | [added: | |]

| [removed: _How] [added: *How] We Addressed the Matter in Our [removed: Audit_] [added: Audit*] | [removed: ​] | [added: |] 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. | [added: | |]

| [removed: *​*] [added: Deferred tax assets:] | [removed: ​] | [removed: Realizability of deferred tax assets] | [added: | | | | | | | | |]

| [removed: ​] | [removed: ​] | [added: |] December 31, | | | | | [removed: ​] | [added: | | |]

| [removed: ​] | [removed: ​] | [added: | 2022 | | | | | |] 2021 | | | [added: | | |] 2020 | | |

| ASSETS | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [added: | | | |]

| Current assets: | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [added: | | | |]

| Cash and cash equivalents | [removed: ​] | [added: |] $ | 2,057,440 | [removed: ​] | [added: | | |] $ | [removed: 1,513,008] [added: —] | [removed: ​] | [added: | | | $ | — | | | | | $ | 2,057,440 | |]

| Marketable securities—available-for-sale (amortized cost [removed: $291,871] [added: $292,580] and [removed: $288,199] [added: $291,871] as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021] respectively; allowance for credit losses $0 as of December 31, [removed: 2021] [added: 2022] and [removed: 2020)] [added: 2021)] | [removed: ​] | | [removed: 290,752] [added: 287,543] | [removed: ​] | | [removed: 288,369] | [removed: ​] | [added: | 290,752 | | |]

| Accounts receivable | [removed: ​] | | [removed: 616,300] [added: 644,879] | [removed: ​] | | [removed: 481,994] | [removed: ​] | [added: | 616,300 | | |]

| Inventory | [removed: ​] | | [removed: 27,904] [added: 41,995] | [removed: ​] | | [removed: 16,425] | [removed: ​] | [added: | 27,904 | | |]

| Prepaid expenses and other current assets | [removed: ​] | [removed: ​] | [removed: 126,278] [added: 167,011] | [removed: ​] | [removed: ​] | [removed: 60,098] | [removed: ​] | [added: | 126,278 | | |]

| Total current assets | [removed: ​] | | [removed: 3,118,674] [added: 4,092,850] | [removed: ​] | | [removed: 2,359,894] | [removed: ​] | [added: | 3,118,674 | | |]

| Restricted cash [removed: and investments] | [removed: ​] | | [removed: 1,720] [added: 1,698] | [removed: ​] | [removed: ​] | [removed: 1,757] | [removed: ​] | [added: | 1,720 | | |]

| Long term investments [added: (Note 7)] | [removed: ​] | | 221,266 | [removed: ​] | [removed: ​] | [removed: 222,301] | [removed: ​] | [added: | — | | | | | | — | | | | | | 221,266 | | |]

| Inventory | [removed: ​] | | [removed: 29,034] [added: 78,964] | [removed: ​] | [removed: ​] | [removed: 19,548] | [removed: ​] | [added: | 29,034 | | |]

| Property and equipment, net | [removed: ​] | | [removed: 723,920] [added: 739,310] | [removed: ​] | [removed: ​] | [removed: 559,625] | [removed: ​] | [added: | 723,920 | | |]

| Finance lease right-of-use assets, net | [removed: ​] | [removed: ​] | [removed: 27,548] [added: 26,298] | [removed: ​] | [removed: ​] | [removed: 28,451] | [removed: ​] | [added: | 27,548 | | |]

| Other intangible assets, net | [removed: ​] | [removed: ​] | [removed: 150,755] [added: 129,219] | [removed: ​] | [removed: ​] | [removed: 172,291] | [removed: ​] | [added: | 150,755 | | |]

| Goodwill | [removed: ​] | [removed: ​] | 155,593 | [removed: ​] | [removed: ​] | [added: | | |] 155,593 | [removed: ​] | [added: |]

| Deferred income tax asset | [removed: ​] | [removed: ​] | [removed: 467,538] [added: 457,941] | [removed: ​] | [removed: ​] | [removed: 2,054] | [removed: ​] | [added: | 467,538 | | |]

| Other assets, net | [removed: ​] | | [removed: 37,304] [added: 25,435] | [removed: ​] | [removed: ​] | [removed: 39,404] | [removed: ​] | [added: | 37,304 | | |]

| Total assets | [removed: ​] | [added: |] $ | [removed: 4,933,352] [added: 5,840,984] | [removed: ​] | [added: | | |] $ | [removed: 3,560,918] [added: 4,933,352] | [removed: ​] |

| LIABILITIES AND STOCKHOLDERS’ EQUITY | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [added: | | | |]

| Current liabilities: | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [removed: ​] | [added: | | | |]

| | | | | | |

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

| | | | | | |

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

| | | | Allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. | | |

| | | | | | |

| | | | | | |

| | | | | | |

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

| | | | | | |

| | | | | | |

| | | | | | |

February 7, 2023

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

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

| | | | 2022 | | | | | | 2021 | | |

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

| Net income (loss) | | | $ | 340,660 | | | | | $ | 948,581 | | | | | $ | (295,697) | |

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

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

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

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

| | | | Common Stock | | | | | | Additional Paid-in Capital | | | | | | Accumulated Other Comprehensive Income (Loss) | | | | | | Accumulated Deficit | | | | | | Total Stockholders’ Equity | | |

| Stock compensation | | | — | | | | | | 189,691 | | | | | | — | | | | | | — | | | | | | 189,691 | | |

| ​ | |

| --- | --- |

| ​ | ​ |

| ​ | ​ | |

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

| *​* | ​ | Allowances for rebates and discounts owed to governmental entities |

| | | Auditing the allowances for rebates and discounts owed to governmental entities, including the Medicaid Drug Rebate Program in the U.S. and Medicare Part D Coverage Gap, 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 and discounts based on the amount of drugs sold to eligible patients, as well as the complexity of the government mandated calculations. The allowances for rebates and discounts owed to governmental entities are sensitive to these significant assumptions and calculations. |

| _Description of the Matter_ | ​ | As discussed in Note 12 to the consolidated financial statements, at December 31, 2021, the Company had deferred tax assets related to deductible temporary differences and tax credit carryforwards of $507.9 million, net of a $408.2 million valuation allowance. Deferred tax assets are reduced by a valuation allowance if, based on the weight of all available evidence, in management’s judgment it is more likely than not that some portion, or all, of the deferred tax assets will not be realized. During the fiscal year ended December 31, 2021, the Company concluded that certain of its deferred tax assets were more likely than not to be realized in the future and released the valuation allowance on a portion of its U.S. deferred tax assets resulting in a tax benefit. Auditing management’s assessment of the realizability of its deferred tax assets involved complex auditor judgment because management’s estimate of future taxable income is highly judgmental and based on significant assumptions that may be affected by future market or economic conditions and the Company’s performance. |

| _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 assessment of the realizability of deferred tax assets. For example, we tested controls over management’s review of the significant assumptions used in estimating the projections of future taxable income, exclusive of reversing temporary differences, as well as controls over management’s review of the scheduling of the future reversals of existing temporary differences. To test the realizability of deferred tax assets, we performed audit procedures that included, among others, evaluating the assumptions used by the Company to develop projections of future taxable income, exclusive of reversing temporary differences, and tested the completeness and accuracy of the underlying data used in its projections. For example, we compared the projections with the actual results of prior periods, as well as management’s consideration of current industry and economic trends. We also assessed the historical accuracy of management’s projections and compared the projections with other forecasted financial information prepared by the Company. Additionally, we performed sensitivity analyses over the forecasted financial information. We also tested the scheduling of the future reversals of existing temporary differences. ​ |

February 8, 2022

| ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |

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

| ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |

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

​

| ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ |

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

| ​ | | ​ | ​ | | ​ | ​ | | Accumulated | | | ​ | ​ | | ​ | ​ | ​ |

| ​ | ​ | ​ | ​ | ​ | Additional | | ​ | Other | | ​ | ​ | ​ | ​ | Total | | ​ |

| ​ | ​ | Common | | ​ | Paid-in | | ​ | Comprehensive | | ​ | Accumulated | | ​ | Stockholders’ | | ​ |

| ​ | ​ | Stock | | ​ | Capital | | ​ | Loss | | ​ | Deficit | | ​ | Equity | | |

| Balances at December 31, 2018 | ​ | $ | 213 | ​ | $ | 3,813,678 | ​ | $ | (10,165) | ​ | $ | (1,877,759) | ​ | $ | 1,925,967 | ​ |

| Stock compensation | ​ | ​ | — | ​ | ​ | 167,029 | ​ | ​ | — | ​ | ​ | — | ​ | ​ | 167,029 | ​ |

| Adoption of ASU No. 2016-02 | ​ | | — | ​ | ​ | — | ​ | ​ | — | ​ | ​ | 95 | ​ | | 95 | ​ |

| Net income | ​ | | — | ​ | | — | ​ | | — | ​ | | 446,906 | ​ | | 446,906 | ​ |

| Other comprehensive loss | ​ | | — | ​ | | — | ​ | | (4,094) | ​ | | — | ​ | | (4,094) | ​ |

| Other, net | ​ | ​ | 1,417 | ​ | ​ | 546 | ​ | ​ | 486 | ​ |

| Interest paid | ​ | $ | 396 | ​ | $ | 194 | ​ | $ | 239 | ​ |

The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law in March 2020 to provide an estimated $2.2 trillion designed to stimulate the U.S. economy during the COVID-19 pandemic.

The Act includes tax relief, government loans, grants and investments for entities in affected industries, which has related accounting and financial reporting impacts.

Disclosure for certain income tax accounting measures are required in the period of enactment and disclosure for government loans, investments, grants, and revenue recognition are required in future periods as federal agencies establish rules and procedures to implement the CARES Act.

During 2020, we delayed the payment of certain employer payroll tax amounts to future periods as allowed under the Act.

We do not expect the CARES Act to have a material impact on our overall financial results, our income tax provision or our liquidity.

We have further described the impact and risks of the COVID-19 pandemic on our business in Item 1A.

Risk Factors.

the primary payers for healthcare.

In making these assessments,

Under our clinical trial collaboration agreements we may be reimbursed for certain development costs incurred.

Such costs are recorded as a reduction of research and development expense in the period in which the related expense is incurred.

the straight-line attribution method for PSUs that are subject to cliff vesting and using the accelerated attribution method for PSUs that are subject to graded vesting.

[removed: _Evaluation] [added: *Evaluation] of disclosure controls and [removed: procedures._] [added: procedures.*] We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood [added: of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.]

[removed: _Changes] [added: *Changes] in internal control over financial [removed: reporting._] [added: 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: 2021,] [added: 2022,] that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

[removed: _Management’s] [added: *Management’s] annual report on internal control over financial [removed: reporting._] [added: reporting.*] Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f).

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in [removed: _Internal] [added: *Internal] Control—Integrated [removed: Framework_] [added: Framework*] issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).

Based on our evaluation under the framework in [removed: _Internal] [added: *Internal] Control—Integrated [removed: Framework_,] [added: Framework*,] our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2021.][added: 2022.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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 [removed: Incyte Corporation] [added: the Company] as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] and the related notes and our report dated February [removed: 8, 2022] [added: 7, 2023] expressed an unqualified opinion thereon.

[removed: |] /s/ Ernst & Young LLP [removed: | ​ |]

February 7, 2023

of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

​

| --- | --- |

February 8, 2022

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: 2022] [added: 2023] Annual Meeting of Stockholders to be held on June [removed: 15, 2022] [added: 14, 2023] (the “Proxy Statement”).

Stockholders may request a free copy of our Code of Business Conduct and Ethics and our Senior Financial Officers’ Code of Ethics by contacting Incyte Corporation, Attention: Investor Relations, 1801 Augustine Cut-Off, Wilmington, DE 19803 or by visiting the Corporate Governance section of our website at [removed: _investor.incyte.com/corporate-governance_.][added: *investor.incyte.com/corporate-governance*.]

We intend to disclose future amendments to certain provisions of our Code of Business Conduct and Ethics or Senior Financial Officers’ Code of Ethics or any waivers, if and when granted, of our Code of Business Conduct and Ethics or Senior Financial Officers’ Code of Ethics on our website at [removed: _www.incyte.com_] [added: *www.incyte.com*] within four business days following the date of such amendment or waiver.

Clancy, as Chairman, Dr. [removed: Wendy L.][added: Jacqualyn A.]

Fouse and Dr. Edmund P.

Harrigan.

Dixon and Dr. Jacqualyn A.

Fouse.

PART [removed: IV][added: IV]

[removed: | (a) | Documents] [added: (a)Documents] filed as part of this report: [removed: |]

[removed: | | (1) | Financial] [added: (1)Financial] Statements [removed: |]

[removed: | | (2) | Financial] [added: (2)Financial] Statement Schedules [removed: |]

[removed: | | (3) | Exhibits |][added: (3)Exhibits]

[removed: | (b) | Exhibits |][added: (b)Exhibits]

| [removed: ExhibitNumber] [added: Exhibit Number] | | [added: | | | |] Description of Document | [added: | |]

| 3(i) | | [added: | | | |] [Integrated copy of the Restated Certificate of Incorporation, as amended, of the Company (incorporated by reference to Exhibit 3(i) to the Company’s Annual Report on Form 10-K for the year ended December 31, 2009).](http://www.sec.gov/Archives/edgar/data/879169/000104746910001834/a2196849zex-3_i.htm) | [added: | |]

| 3(ii) | | [added: | | | |] [Bylaws of the Company, as amended as of February 18, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed February 19, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000110465921025501/tm217190d1_ex3-1.htm) | [added: | |]

| 4.1 | | [added: | | | |] [Form of Common Stock Certificate (incorporated by reference to the Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2002).](http://www.sec.gov/Archives/edgar/data/879169/000102140803005282/dex41.htm) | [added: | |]

| 4.2 | | [added: | | | |] [Description of Registrant’s Securities Registered under Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.3 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837020000774/ex-4d3.htm) | [added: | |]

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

| 10.2# | | [added: | | | |] [Form of Global Stock Option Agreement for Executive Officers under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020012834/incy-20200930xex10d1.htm) | [added: | |]

| 10.3# | | [added: | | | |] [Form of Global Restricted Stock Unit Award Agreement under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020012834/incy-20200930xex10d2.htm) | [added: | |]

| 10.4# | | [added: | | | |] [Form of Performance Share Award Agreement under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020012834/incy-20200930xex10d3.htm) | [added: | |]

| 10.5# | | [added: | | | |] [Form of Nonstatutory Stock Option Agreement for Outside Directors under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013).](http://www.sec.gov/Archives/edgar/data/879169/000104746914001174/a2218324zex-10_24.htm) | [added: | |]

| 10.6# | | [added: | | | |] [Form of Restricted Stock Unit Award Agreement for Outside Directors under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019006550/incy-20190630ex101dc8f47.htm) | [added: | |]

| 10.7# | | [added: | | | |] Form of Indemnity Agreement between the Company and its directors and officers (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 33 68138)). | [added: | |]

| 10.8# | | [added: | | | |] [1997 Employee Stock Purchase Plan of Incyte Corporation, as amended and restated effective November 17, 2020 (incorporated by reference to Exhibit 10.8 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021000825/incy-20201231xex10d8.htm) | [added: | |]

| 10.9# | | [added: | | | |] [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, 2016), Maria E. Pasquale (effective as of April 9, 2018) and Dashyant Dhanak (effective as of December 10, 2018) (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) | [added: | |]

| 10.10# | | [added: | | | |] [Form of Amended and Restated Employment Agreement, effective as of April 18, 2012, between the Company and Paula J. Swain (incorporated by reference to Exhibit 10.14 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012).](http://www.sec.gov/Archives/edgar/data/879169/000110465912029092/a12-6693_1ex10d14.htm) | [added: | |]

| 10.11# | | [added: | | | |] [Offer of Employment Letter, dated December 14, 2018, from the Company to Christiana Stamoulis (incorporated by reference to Exhibit 10.2 to the [removed: Company’s] [added: Company's] Quarterly Report on Form 10-Q for the quarter ended March 31, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019003610/incy-20190331ex102573f77.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019003610/incy-20190331ex102573f77.htm)] | [added: | |]

| 10.12# | | [added: | | | |] [Amended and Restated Employment Agreement between the Company and Hervé Hoppenot, dated as of October 25, 2019 (incorporated by reference to Exhibit 10.3 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-20190930ex10388737b.htm) | [added: | |]

| 10.13† | | [added: | | | |] [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) | [added: | |]

| 10.13.1† | | [added: | | | |] [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) | [added: | |]

| 10.13.2†† | | [added: | | | |] [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) | [added: | |]

| 10.14† | | [added: | | | |] [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) | [added: | |]

| 10.14.1† | | [added: | | | |] [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) | [added: | |]

| 10.14.2† | | [added: | | | |] [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) | [added: | |]

| [removed: 10.14.3†] [added: 10.14 .3†] | | [added: | | | |] [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) | [added: | |]

| 10.14.4†† | | [added: | | | |] [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) | [added: | |]

| [removed: 10.15†] [added: 10.15 †] | | [added: | | | |] [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) | [added: | |]

| 10.15.1† | | [added: | | | |] [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) | [added: | |]

| [removed: 10.17†] [added: 10.16] | | [removed: [Collaboration and License] [added: | | | | [Registration Rights] Agreement, dated [removed: December 20,] [added: as of February 12,] 2016, [removed: by and] between the Company and [removed: Merus N.V.] [added: 667, L.P., Baker Brothers Life Sciences, L.P. and 14159, L.P.] (incorporated by reference to Exhibit [removed: 10.27 to Amendment No. 2 on Form 10-K/A] [added: 10.28] to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2016).](http://www.sec.gov/Archives/edgar/data/879169/000110465917043033/a17-15971_1ex10d27.htm)] [added: 2015).](http://www.sec.gov/Archives/edgar/data/879169/000155837016003196/incy-20151231ex10283b05a.htm)] | [added: | |]

| [removed: 10.19.2] [added: 10.17] | | [removed: [Second Amendment,] [added: | | | | [Revolving Credit and Guaranty Agreement,] dated as of [removed: January 8,] [added: August 18,] 2021, [removed: to Collaboration and License Agreement entered into as of January 12, 2020 by and] among the Company, [removed: MorphoSys AG] [added: the guarantors party thereto, the lenders party thereto,] and [removed: MorphoSys US Inc.] [added: 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 [removed: March 31, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021005692/incy-20210331xex10d1.htm)] [added: September 30, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021014131/incy-20210930xex10d1.htm)] | [added: | |]

| 21.1* | | [added: | | | |] [Subsidiaries of the [removed: Company.](https://www.sec.gov/Archives/edgar/data/879169/000155837022000902/incy-20211231xex21d1.htm)] [added: Company.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit211-12312022.htm)] | [added: | |]

| 23.1* | | [added: | | | |] [Consent of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000155837022000902/incy-20211231xex23d1.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000087916923000008/exhibit231-12312022.htm)] | [added: | |]

| 24.1* | | [removed: [Power] [added: | | | | Power] of Attorney (included on the signature page to this Annual Report on Form [removed: 10-K).](#PowerOfAttorney)] [added: 10-K).] | [added: | |]