What changed in this filing

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Item 1. Business

2025-02-10 compared with 2024-02-13 · 168 added, 192 removed, 683 unchanged (35% of the section changed)

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Hematology and Oncology

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

Our hematology and oncology franchise comprises six approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), ZYNYZ (retifanlimab-dlwr), and NIKTIMVO (axatilimab-csfr), as well as numerous clinical development programs.

JAKAFI (ruxolitinib)

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MF, considered the most serious of the myeloproliferative neoplasms, can occur either as primary MF, or as secondary MF that develops in some patients who previously had polycythemia vera or essential thrombocythemia.

We estimate there are between 16,000 and 18,500 patients with MF in the United States.

Based on the modern prognostic scoring systems referred to as International Prognostic Scoring System and Dynamic International Prognostic Scoring System, we believe intermediate and high-risk patients represent 80% to 90% of all patients with MF in the United States and encompass patients over the age of 65, or patients who have or have ever had any of the following:

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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.

When phlebotomy can no longer control PV, chemotherapy such as hydroxyurea, or interferon, is utilized.

Approximately 25,000 patients with PV in the United States are considered uncontrolled because they have an inadequate response to or are intolerant of hydroxyurea, the most commonly used chemotherapeutic agent for the treatment of PV.

In December 2014, the FDA approved JAKAFI for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea.

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In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack various tissues.

12-month survival rates in patients with Grade III or IV steroid-refractory acute GVHD are 50% or less, and the incidence of steroid-refractory acute and chronic GVHD is approximately 3,000 per year in the United States.

In June 2016, we announced that the FDA granted Breakthrough Therapy designation for ruxolitinib in patients with acute GVHD.

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Under the terms of the collaboration and license agreement, we received rights to co-commercialize tafasitamab in the United States with MorphoSys, and exclusive development and commercialization rights outside of the United States.

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

As more fully described in Note 5 of Notes to the Consolidated Financial Statements, in February 2024, we entered into a purchase agreement with MorphoSys, and as a result, we now hold exclusive global rights for tafasitamab, and the collaboration and license agreement was terminated.

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

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

In August 2020, we and MorphoSys announced that MONJUVI in combination with lenalidomide had been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas.

In August 2020, we and MorphoSys announced that MONJUVI in combination with lenalidomide had been included in the latest NCCN Clinical Practice Guidelines in Oncology for B-cell Lymphomas.

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

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Warnings and precautions for MINJUVI include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases.

DLBCL is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.

It is an aggressive disease with ~40% of patients not responding to initial therapy or relapsing thereafter.

We estimate that there are ~10,000 patients diagnosed in the United States each year with r/r DLBCL who are not eligible for ASCT.

In the EU, we estimate there are ~14,000 patients diagnosed each year with r/r DLBCL who are not eligible for ASCT.

In December 2024, we submitted a sBLA for tafasitamab in relapsed or refractory follicular lymphoma (FL) to the FDA.

PEMAZYRE (pemigatinib)

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ZYNYZ (retifanlimab-dlwr)

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

In October 2017, we and MacroGenics, Inc., announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1).

Under this collaboration, we obtained exclusive worldwide rights for the development and commercialization of retifanlimab in all indications.

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

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

In March 2023, we announced that the FDA had approved ZYNYZ (retifanlimab-dlwr) under accelerated approval, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

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

Clinical Programs in Hematology and Oncology

We are evaluating combinations of ruxolitinib with other therapeutic modalities, as well as developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and combination therapy.

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

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

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

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

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

In April 2024, the European Commission approved ZYNYZ (retifanlimab) as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

In September 2024, we announced positive results from the Phase 3 POD1UM-303/InterAACT2 trial of ZYNYZ (retifanlimab) in combination with platinum-based chemotherapy (carboplatin–paclitaxel) for the treatment of adults with inoperable locally recurrent or metastatic SCAC.

In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab in advanced/metastatic SCAC was filed with the FDA with approval anticipated in the second half of 2025.

NIKTIMVO (axatilimab-csfr)

In September 2021, we and Syndax Pharmaceuticals, Inc.

announced an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody.

Together, we plan to develop axatilimab as a therapy for patients with chronic GVHD where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.

Together, we are developing axatilimab as a therapy for patients with chronic GVHD where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.

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

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

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

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

INCA033989 (mCALR)

In December 2023, a Biologics License Application (BLA) was submitted to the FDA for axatilimab for the treatment of patients with chronic GVHD after failure of two or more lines of systemic therapy and accepted for Priority Review in February 2024.

We have initiated two combination trials with axatilimab in cGVHD in 2024, including a randomized Phase 2 combination trial with ruxolitinib and a randomized Phase 3 combination trial with steroids, both directed at treating patients with cGVHD in earlier lines of therapy.

In August 2024, we and Syndax announced the FDA approval of NIKTIMVO (axatilimab-csfr) for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients.

NIKTIMVO is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD.

In September, we and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of NIKTIMVO in chronic GVHD and the addition of NIKTIMVO to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.

In January 2025, the FDA approved two smaller vial sizes (9mg and 22mg) of NIKTIMVO to facilitate patient dosing and limit product waste.

commercial launch of NIKTIMVO commenced at th e end of January 2025.

Clinical Programs in Hematology and Oncology

We are evaluating combinations of ruxolitinib with other therapeutic modalities, as well as developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and in combinations.

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

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

Phase 2 trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) in patients with MF are ongoing with data presented demonstrating early signals of clinical activity in monotherapy and in combination with ruxolitinib.

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.

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

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

A Phase 1 study of INCB160058 was initiated in the first quarter of 2024.

Tafasitamab is an anti-CD19 antibody and is being investigated as a therapeutic option in B cell malignancies in a number of ongoing and planned combination trials.

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

A placebo-controlled Phase 3 trial (inMIND) of tafasitamab added to lenalidomide plus rituximab (R 2 ) in patients with relapsed or refractory follicular or marginal zone lymphomas is ongoing.

In January 2021, the FDA granted orphan drug designation to tafasitamab as a treatment for patients with follicular lymphoma.

Pemigatinib is a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR) isoforms 1, 2 and 3 with demonstrated activity in preclinical studies.

The FGFR family of receptor tyrosine kinases can act as oncogenic drivers in a number of liquid and solid tumor types.

We initiated the FIGHT clinical program to evaluate pemigatinib across a spectrum of cancers that are driven by FGF/FGFR alterations.

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

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

FIGHT-207, a solid tumor-agnostic trial evaluating pemigatinib in patients with driver-alterations of FGF/FGFR, is now closed to recruitment.

Based on findings from this study, we have identified populations that potentially may benefit from treatment with pemigatinib, and a Phase 2 trial, FIGHT-209, in patients with glioblastoma is ongoing.

Pemigatinib has Breakthrough Therapy designation as a treatment for patients with myeloid/lymphoid neoplasms (MLN) with FGFR1 rearrangement who have relapsed or are refractory to initial chemotherapy.

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

In July 2021, we announced that the FDA issued a complete response letter (CRL) for the BLA of retifanlimab for the treatment of SCAC.

In October 2021, we announced that we withdrew the MAA seeking approval of retifanlimab in SCAC.

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

In November 2021, we highlighted Phase 1 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 2 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.

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

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

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

W e and Replimune Group, Inc.

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

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

In December 2024, we announced the full results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL).

The data showed that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with FL.

Tafasitamab was generally well-tolerated, and safety was consistent with other CD19 and immunotherapy combination regimens.

In July 2024, we announced positive topline results from both the two Phase 3 clinical studies evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in SCAC and NSCLC.

The phase 3 study in SCAC met its primary endpoint of progression free survival while the Phase 3 study in NSCLC meet its primary endpoint of overall survival.

The safety analysis from both studies showed retifanlimab was generally well-tolerated with no new safety signals observed.

POD1UM-303 is a Phase 3, global, multicenter, randomized, double-blind study evaluating carboplatin-paclitaxel with retifanlimab or placebo in patients with inoperable locally recurrent or metastatic SCAC who have not previously been treated with chemotherapy.

POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or nonsquamous NSCLC.

In September 2024, we presented late-breaking Phase 3 results for retifanlimab that were featured during the 2024 European Society for Medical Oncology (ESMO) Presidential Symposium.

The Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of PFS and demonstrated improvement across key secondary endpoints in patients with SCAC receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel).

MPN, GVHD and Oncology Programs Indication and Phase

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(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD

Ruxolitinib + zilurgisertib

(JAK1/JAK2 + ALK2) Myelofibrosis:

Ruxolitinib + INCB57643

(JAK1/JAK2 + BET) Myelofibrosis:

Ruxolitinib + CK0804 1

(JAK1/JAK2 + CB-Tregs)

Myelofibrosis:

Phase 1 (LIMBER-TREG108)

Axatilimab (anti-CSF-1R) 2

Chronic GVHD:

Pivotal Phase 2 (third-line plus therapy) (AGAVE-201);

BLA under review in the U.S.

(JAK1/JAK2 + BETi) Myelofibrosis:

Ruxolitinib + axatilimab 1

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Chronic GVHD:

Phase 1/2 in preparation

(mCALR) Myelofibrosis, essential thrombocythemia:

(JAK2V617Fi) Phase 1

Pemigatinib (PEMAZYRE)

Myeloid/lymphoid neoplasms (MLN):

approved in the U.S.

Cholangiocarcinoma (CCA):

Phase 3 (FIGHT-302)

Glioblastoma:

Phase 2 (FIGHT-209)

Steroids + axatilimab 1

(Steroids + anti-CSF-1R)

Chronic GVHD:

(mutCALR) Myelofibrosis, essential thrombocythemia:

(JAK2V617Fi) Myelofibrosis:

Tafasitamab (MONJUVI/MINJUVI)

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Phase 3 ( front MIND)

Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL):

Relapsed or refractory follicular lymphoma (FL):

Phase 3 ( in MIND)

Retifanlimab (ZYNYZ) 2

Merkel cell carcinoma (MCC):

approved in the U.S.

Squamous cell anal cancer (SCAC):

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Phase 2 (POD1UM-101, POD1UM-204)

(Oral PD-L1) Solid tumors (combination):

Solid tumors (monotherapy):

Cutaneous squamous cell carcinoma (cSCC):

(Oral PD-L1) Solid tumors:

(CDK2i) Solid tumors with Amplification/ Overexpression of CCNE1:

(KRASG12D) Advanced metastatic solid tumors with a KRAS G12D mutation:

Development collaboration with Cellenkos, Inc.

(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression:

(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation:

(TGFßR2×PD-1) 3

Advanced or metastatic solid tumors:

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

Retifanlimab licensed from MacroGenics.

Development collaboration with Merus.

Earlier-Stage Development Programs in Hematology and Oncology

In July 2024, we announced a strategic review of our pipeline with an increased focus on high potential impact programs.

As a result, we discontinued further development of both oral, small molecule PD-L1 inhibitors.

Additionally, we plan to forgo further development of our LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific program.

INCB123667 (CDK2)

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Additional data from this trial is anticipated in 2025.

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.

In September 2024, we presented initial data from the Phase 1 CDK2 inhibitor program at the 2024 ESMO Congress.

Phase 1 data of INCB123667 were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1.

The Phase 1 trial is ongoing with INCB123667 in combination with other agents.

We currently anticipate initiating a pivotal trial in ovarian cancer in 2025.

INCB161734 (KRASG12D)

A Phase 1 study evaluating INCB161734 (KRASG12D) was initiated in the first quarter of 2024.

INCB161734 is a potent, selective and orally bioavailable KRAS G12D inhibitor and, as highlighted at AACR in April 2024, has shown excellent efficacy in several preclinical models.

With no currently approved G12D-targeting agents, INCB161734 could address an important patient need as the KRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancers.

Data from the ongoing Phase 1 study is expected in 2025.

INCA33890 (TGFβR2xPD-1) 1

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In July 2023, we initiated a Phase 1 study evaluating INCA33890 in patients with select advanced solid tumors.

Our earlier-stage clinical programs in hematology and oncology are included in the table below.

We intend to describe these programs more fully if we obtain clinical proof-of-concept and establish that a program warrants further development in a specific indication or group of indications.

Modality Candidates

Monoclonal antibodies INCAGN2385 (LAG-3) 1 , INCAGN2390 (TIM-3) 1

Bi-specific antibodies INCA32459 (LAG-3xPD-1) 2 , INCA33890 (TGFβR2xPD-1) 2

Discovery collaboration with Agenus Inc.

Development collaboration with Merus.

Data from the ongoing Phase 1 study is expected in 2025.

Inflammation and AutoImmunity (IAI)

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OPZELURA subsequently was approved by the FDA and European Commission for vitiligo in July 2022 and April 2023, respectively.

Incyte’s IAI efforts also include numerous clinical development programs.

Our IAI efforts also include numerous clinical development programs.

OPZELURA (ruxolitinib) cream

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The most common (≥1%) treatment-emergent adverse reactions in patients treated with OPZELURA were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea.

1 In collaboration with Merus.

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.

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Vitiligo is a chronic autoimmune depigmenting skin disease characterized by patches of the skin losing their pigment.

It is estimated that there are at least 1.5 million patients diagnosed with vitiligo in the United States, with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo.

OPZELURA is the first and only FDA approved treatment for repigmentation of vitiligo lesions.

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In March 2023, long-term 104-week safety and efficacy data for ruxolitinib cream in vitiligo were presented at the American Academy of Dermatology (AAD) conference, demonstrating that patients who achieved a high level of facial repigmentation (≥F-VASI90) at Week 52 maintained durable response one year following withdrawal of treatment and that those patients who continued treatment with OPZELURA for up to two years demonstrated sustained facial repigmentation and further improvements in facial and total body repigmentation.

In April 2023, we announced that the European Commission had approved OPZELURA for the topical treatment of nonsegmental vitiligo with facial involvement in adults and adolescents 12 years and older following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

In October 2023, new results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing OPZELURA cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24 were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023 as a late-breaking oral presentation.

These results showed that patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with OPZELURA for up to two years.

In January 2024, Incyte received approval in France to promote and distribute OPZELURA for vitiligo under a process called “Accès Direct.” This process is intended to allow for early access to a therapy while a final price is negotiated, which is expected to take up to twelve months.

In October 2024, OPZELURA cream 1.5% was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.

Clinical Programs in Dermatology

Ruxolitinib cream

Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including atopic dermatitis, vitiligo, lichen planus, lichen sclerosus, hidradenitis suppurativa and prurigo nodularis.

In October 2021, we announced the validation of the MAA for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with nonsegmental vitiligo with facial involvement.

Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including AD, vitiligo, lichen planus, lichen sclerosus, hidradenitis suppurativa (HS) and prurigo nodularis (PN).

In November 2022, we initiated two Phase 2 trials evaluating ruxolitinib cream in lichen planus and lichen sclerosus.

Lichen planus is a recurrent inflammatory condition affecting the skin and mucosal surfaces and can result in itchy, purple bumps on the skin.

Lichen sclerosus is a chronic inflammatory skin disease most commonly affecting women and can result in painful ulcers and intense itching.

Two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis were initiated in 2023.

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Again, significantly more patients treated with ruxolitinib cream (0.75% and 1.5%) achieved Investigator’s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream).

In January, 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in Hidradenitis Suppurativa (HS).

In January 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in HS.

Ruxolitinib 1.5% cream BID met the primary efficacy endpoint as measured by a change from baseline in abscess and nodule count at Week 16 versus placebo in patients with mild to moderate HS.

Ruxolitinib cream was well tolerated and consistent with its known safety profile.

A Phase 3 study is currently under evaluation.

We also are developing povorcitinib (formerly INCB54707), which is an oral small molecule selective JAK1 inhibitor.

Povorcitinib is undergoing evaluation in patients with hidradenitis suppurativa (HS), nonsegmental vitiligo, prurigo nodularis (PN), asthma and chronic spontaneous urticaria (CSU).

A Phase 3 study is expected to initiate in 2025.

In October 2024, we disclosed results from the Phase 2 study of ruxolitinib cream in patients with cutaneous lichen planus.

At this time, we do not plan to advance ruxolitinib cream into a registrational study for lichen planus and plan to publish the results of this study in the future.

Additionally, the Phase 2 study evaluating ruxolitinib cream for lichen sclerosus did not meet our internal bar for success and at this time, we are not planning to advance this indication into a registrational study.

In October 2024, we announced the Phase 3 trial for ruxolitinib cream in mild to moderate HS is on track to initiate in the first half of 2025 following achieving alignment on the study design with the FDA.

We also are developing povorcitinib, which is an oral small molecule selective JAK1 inhibitor.

Povorcitinib is undergoing evaluation in patients with hidradenitis suppurativa, nonsegmental vitiligo, prurigo nodularis, asthma and chronic spontaneous urticaria (CSU).

Hidradenitis Suppurativa.

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In October 2023, we announced that the Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN had met its primary endpoint.

A Phase 3 study in PN is being planned.

In October 2024, following the positive Phase 2 results, two Phase 3 studies in patients with PN were initiated.

Asthma and Chronic Spontaneous Urticaria.

In July 2023, we initiated two Phase 2 trials evaluating povorcitinib in patients with moderate to severe uncontrolled asthma and in chronic spontaneous urticaria.

Data for CSU are anticipated in the first half of 2025 and data in asthma are anticipated in the second half of 2025.

INCB000262 (MRGPRX2) & INCB000547 (MRGPRX4)

As more fully described in Note 5 of Notes to the Consolidated Financial Statements, in May 2024, we acquired Escient Pharmaceuticals, Inc.

Escient is a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders.

Escient’s clinical development portfolio includes INCB000262 , a potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and INCB000547 , an oral MRGPRX4 antagonist.

In November 2024, we announced that enrollment was paused in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in CSU.

The decision was made following the observation of certain in vivo preclinical toxicology findings.

These data have been shared with the FDA and at this time, we have no intention to enroll additional patients.

Enrollment in the other INCB000262 proof-of-concept studies in chronic inducible urticaria and AD is complete.

In November 2024, Incyte announced data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus did not support further development.

IAI and Dermatology Programs Indication and Phase

Ruxolitinib cream (OPZELURA) 1

Atopic dermatitis:

Phase 3 pediatric study (TRuE-AD3)

Approved in the U.S.

Lichen planus:

Lichen sclerosus:

Hidradenitis suppurativa:

Phase 3 being evaluated

Phase 3 expected to initiate in 2025

Prurigo nodularis:

Phase 3 (TRuE-PN1, TRuE-PN2)

Ruxolitinib cream + UVB

(JAK1/JAK2 + phototherapy) Vitiligo:

(JAK1) Hidradenitis suppurativa:

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Prurigo nodularis:

Phase 3 in planning

Phase 3 (STOP-PN1, STOP-PN2)

Chronic spontaneous urticaria:

(anti-IL-15Rβ) Vitiligo:

Phase 1 initiated

(anti-CD122) Vitiligo:

Novartis’ rights for ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.

Earlier-Stage Development Programs in Dermatology

INCA034460 (anti-CD122)

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

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All four Phase 3 trials met their respective primary endpoints.

In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and an MAA to the EMA for baricitinib as treatment for rheumatoid arthritis.

In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and an MAA to the European Medicines Agency (EMA) for baricitinib as treatment for rheumatoid arthritis.

In February 2017, we and Lilly announced that the European Commission approved baricitinib as OLUMIANT for the treatment of moderate-to-severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

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Approved in the U.S., Europe and Japan

Capmatinib (TABRECTA) 3

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Approved in the U.S., Europe and Japan

ruxolitinib licensed to Novartis outside of the United States for use in hematology and oncology excluding topical administration.

baricitinib licensed to Lilly.

capmatinib licensed to Novartis.

Ruxolitinib (JAKAVI) licensed to Novartis outside of the United States for use in hematology and oncology excluding topical administration.

Baricitinib (OLUMIANT) licensed to Lilly.

Capmatinib (TABRECTA) licensed to Novartis.

License Agreements and Business Relationships

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Below is a brief description of our significant business relationships and collaborations and related license agreements that expand our pipeline and provide us with certain rights to existing and potential new products and technologies.

Additional information regarding our collaboration agreements, including their financial and accounting impact on our business and results of operations, can be found at Note 7 of Notes to the Consolidated Financial Statements.

Additional information regarding our collaboration agreements, including their financial and accounting impact on our business and results of operations, can be found in Note 5 and Note 7 of Notes to the Consolidated Financial Statements.

Out-License Agreements

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In-License Agreements

In January 2015, we entered into a License, Development and Commercialization Agreement with Agenus Inc.

and its wholly-owned subsidiary, 4-Antibody AG (now known as Agenus Switzerland Inc.), which we collectively refer to as Agenus.

Under this agreement, the parties have agreed to collaborate on the discovery of novel immuno-therapeutics using Agenus’ antibody discovery platforms.

In October 2017, we entered into a Global Collaboration and License Agreement with MacroGenics.

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The collaboration encompasses up to ten independent programs.

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.

Axatilimab was granted Orphan Drug Designation by the FDA in March 2021 for the treatment of chronic GVHD and again in April 2021 for the treatment of idiopathic pulmonary fibrosis.

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

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

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Our strategy is to develop and commercialize compounds that we have internally discovered or have acquired rights to in the markets where we believe that a company of our size can successfully compete.

We currently commercialize five compounds in the United States, three in Europe and one in Japan.

We currently commercialize six compounds in the United States, three in Europe and one in Japan.

These commercialized products are sold to specialty and retail pharmacies, specialty distributors and wholesalers in the United States in addition to retail pharmacies, hospital pharmacies, distributors and an exclusive wholesaler outside of the United States.

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For certain compounds, we have established and may in the future establish collaborations or strategic relationships to support development and commercialization in certain territories or therapeutic areas where we do not have or do not want to build expertise.

We believe the key benefits to entering into such strategic relationships include the potential to expedite the development and commercialization of certain of our compounds, as well as the opportunity to receive upfront payments and future milestones and royalties in exchange for certain rights to those compounds.

receive upfront payments and future milestones and royalties in exchange for certain rights to those compounds.

Refer to the “License Agreements and Business Relationships” section above for information regarding our collaborations and strategic relationships.

Patents and Other Intellectual Property

Patents, Other Intellectual Property, and Product Exclusivity

We regard the protection of patents and other enforceable intellectual property rights that we own or license as critical to our business and competitive position.

Accordingly, we rely on patent, trademark, trade secret and copyright law, as well as nondisclosure and other contractual arrangements, to protect our intellectual property.

We have established a patent portfolio of patents and patent applications owned or licensed by us that cover aspects of all our drug products and drug candidates.

The patents and patent applications relating to our drug products and drug candidates generally include claims directed to the compounds, methods of using the compounds, formulations of the compounds, pharmaceutical salt forms of the compounds, and methods of manufacturing the compounds.

We have established a patent portfolio of patents and patent applications owned or licensed by us that cover aspects of our drug products and drug candidates.

Our policy is to pursue patent applications on inventions and discoveries that we believe are commercially important to the development and growth of our business.

The following table sets forth the status of the patents and patent applications in the United States, the European Union, and Japan for our approved medicines and for those compounds in our portfolio that have been submitted to regulatory authorities seeking approval or are in registration-directed clinical trials:

Drug/Drug Candidate (Target) Status of U.S.

Composition of Matter Patent Estate

(Earliest Anticipated Expiration

Including PTE Extensions where granted) 3

Status of EU Composition of Matter Patent Estate (Earliest Anticipated Expiration Including SPC Extensions where granted) 3

Status of Japan Composition of Matter Patent Estate (Earliest Anticipated Expiration Including SPC Extensions where granted) 3

ruxolitinib (JAK) 1,2

Granted and pending (2028) 9

Granted and pending (2027) 9

Granted and pending (2028) 9

baricitinib (JAK) Granted and pending (2030) 5

Granted and pending (2032) Granted and pending (2033)

itacitinib (JAK) Granted and pending (2032) 4

Granted and pending (2031) 4

capmatinib (MET) Granted and pending (2027) 5

Granted and pending (2027) 5

Granted and pending (2032)

pemigatinib (FGFR) Granted and pending (2035) 5

Granted and pending (2033) 5

Granted and pending (2036)

ponatinib (BCRABL) Granted and pending (2028)

retifanlimab (PD-1) 6

Granted and pending (2036) 10

tafasitamab (CD19) 7

Granted and pending (2029) 5

Granted (2027) 5

Granted (2027) 4

axatilimab (CSF-1R) 8

Granted (2034) 4

Granted and pending (2034) 4

povorcitinib (JAK) Granted and pending (2034) 4

Granted and pending (2034) 4

Ruxolitinib cream formulation patents are issued in the United States, European Union and Japan with anticipated expiration dates of 2031 in each jurisdiction.

This does not include patent term extensions which we plan to seek upon further regulatory approval.

Patents are issued in the United States to the treatments of atopic dermatitis and vitiligo with expiration dates of 2040.

Once-a-day (QD) ruxolitinib formulation patents are issued in the United States, the European Union and Japan, with anticipated expiration dates of 2033 in each of these jurisdictions, not including patent term extensions that we plan to seek upon regulatory approval.

Subject to the payment of maintenance fees.

We plan to seek respective patent term extension/supplementary protection certificate (SPC) upon approval by the respective regulatory agency.

Patent term extension/SPC has been applied for and being sought.

As a general matter, we endeavor to obtain patent term extensions (PTEs) in the United States and Japan, and other countries where available, and supplementary protection certificates (SPCs) in each European country, upon approval by the respective regulatory agency, if patent rights are granted in such country.

The following table sets forth the year in which the basic exclusivity loss is currently estimated to occur in the United States, the European Union, and Japan for each of our approved medicines and for those compounds in our portfolio that have been submitted to regulatory authorities seeking approval or are in registration-directed clinical trials.

We refer to the basic exclusivity loss as the “Estimated Minimum Market Exclusivity Date,” which is, unless otherwise indicated, the latter of (i) the expiration date of the earliest anticipated expiring composition of matter patent rights, or (ii) the date of regulatory data protection (RDP) loss for such product or clinical candidate.

There may be additional patents for our approved medicines that claim the medicine or a method of using it that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)—or for our unapproved clinical candidates that will be eligible to be listed in the Orange Book upon FDA approval.

Therefore, the table below also identifies the expiration dates of certain additional patents that are Orange-Book listed for our approved medicines—or that, for our unapproved clinical candidates, are eligible for Orange-Book listing upon product approval—in the United States, as well as the expiration dates of certain related patents in the European Union, and Japan, which we refer to as the “Additional Patents Expiry Dates.”

Product/Drug Candidate 1,2

JAKAFI (ruxolitinib)

Estimated Minimum Market Exclusivity Dates 2028

Additional Patents Expiry Dates 3

2028 2028 2028

OPZELURA (ruxolitinib) cream

Estimated Minimum Market Exclusivity Dates 2028

Additional Patents Expiry Dates 3,4

2028, 2031 & 2040 2028 & 2031 2028 & 2031

OLUMIANT (baricitinib) Estimated Minimum Market Exclusivity Dates 2032 5

Additional Patents Expiry Dates 2032 2032 -

TABRECTA (capmatinib) Estimated Minimum Market Exclusivity Dates 2032 5

Additional Patents Expiry Dates 2035 2035 2035

PEMAZYRE (pemigatinib)

Estimated Minimum Market Exclusivity Dates 2035

Additional Patents Expiry Dates 2039 & 2040 - -

ICLUSIG (ponatinib) Estimated Minimum Market Exclusivity Dates - 2028 -

Additional Patents Expiry Dates - - -

ZYNYZ (retifanlimab) 8

Estimated Minimum Market Exclusivity Dates 2036

MONJUVI (tafasitamab) 9

Estimated Minimum Market Exclusivity Dates 2033 5

NIKTIMVO (axatilimab) 10

Estimated Minimum Market Exclusivity Dates 2036 7

ruxolitinib XR Estimated Minimum Market Exclusivity Dates 2028

Additional Patents Expiry Dates 3,11

2028 & 2033 - -

povorcitinib Estimated Minimum Market Exclusivity Dates 2034 2034 2034

Additional Patents Expiry Dates 2039 & 2041 2039 -

Estimated Minimum Market Exclusivity Dates are subject to the payment of maintenance fees, and include the period of PTE that has been granted by the respective regulatory agency, where applicable, or include the period of anticipated SPC term for approved products in the EU, where applicable, even though SPCs may remain pending in some countries.

For approved medicines in the US, the brand name for the US product is used, whereas for candidates that have not been approved in the US, the name of the active ingredient is used.

The use of a brand name in the table does not indicate that the product has also been approved in any country outside of the US Also, some products may be approved in one or more countries outside of the US under different brand names.

Ruxolitinib phosphate salt patents are issued in the US, EU and Japan with anticipated expiration dates of late-2028 in the US and mid-2028 in the EU and Japan.

Ruxolitinib cream formulation patents are issued in the US, EU and Japan with anticipated expiration dates of 2031 in each jurisdiction.

Patents are also issued in the US for the treatments of atopic dermatitis and vitiligo with expiration dates of 2040.

Date reflects the grant of PTE in the US.

Date reflects the grant of SPC in the EU, although SPCs may remain pending in some countries.

Date reflects the RDP in the US due to product approval.

Retifanlimab licensed from MacroGenics.

Tafasitamab and its composition of matter patents licensed from Xencor, Inc..

Tafasitamab licensed from Xencor, Inc.

Axatilimab licensed from Syndax.

Ruxolitinib phosphate salt patents are issued in the United States, European Union and Japan with anticipated expiration dates of late-2028 in the United States and mid-2028 in the European Union and Japan, not including patent term extensions.

We have applied for patent term extension in the United States.

We likewise plan to seek supplementary protection certificates (SPC) in the European Union and patent term extension in Japan following approval by the respective regulatory authorities.

Once-a-day (QD) ruxolitinib formulation patents are issued in the US with anticipated expiration dates of 2033.

Patents extend for varying periods according to the date of patent filing and the legal term of patents in the various countries where patent protection is obtained.

The actual protection afforded by a patent, which can vary from country to country, depends on the type of patent, the scope of its coverage and the availability of legal remedies in the country.

We may seek to license rights relating to technologies, drug candidates or drug products in connection with our drug discovery and development programs and commercialization activities.

Under these licenses, such as our licenses from Agenus, ARIAD/Takeda, MacroGenics, Merus, Xencor and Syndax, we may be required to pay up-front fees, license fees, milestone payments and royalties on sales of future products.

Patents extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained.

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We may seek to license rights relating to technologies, drug candidates or drug products in connection with our drug discovery and development programs and commercialization activities.

Under these licenses, such as our licenses from Agenus, ARIAD/Takeda, MacroGenics, Merus, and Syndax, we may be required to pay up-front fees, license fees, milestone payments and royalties on sales of future products.

Under these licenses, such as our licenses from Agenus, ARIAD/Takeda, MacroGenics, Merus Xencor and Syndax, we may be required to pay up-front fees, license fees, milestone payments and royalties on sales of future products.

Although we believe our rights under patents and patent applications provide a competitive advantage, the patent positions of pharmaceutical and biotechnology companies are highly uncertain and involve complex legal and factual questions.

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We could incur substantial costs in such litigation or other proceedings.

An adverse outcome in any such litigation or proceeding could subject us to significant liability.

An adverse outcome in any such litigation or proceeding could subject us to significant liability or increased competition.

A discussion of certain risks and uncertainties that may affect our patents, regulatory exclusivities or other proprietary rights is set forth in Item 1A.

“Risk Factors — Risks Relating to Intellectual Property and Legal Matters,” and the discussion of legal proceedings related to certain patents is set forth in Item 1A.

“Risk Factors — Risks Relating to Commercialization of Our Products — Competition for our products could harm our business and result in a decrease in revenue.”

With respect to proprietary information that is not patentable, and for inventions for which patents are difficult to enforce, we rely on trade secret protection and confidentiality agreements to protect our interests.

While we require all employees, consultants and potential business partners to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information.

While, as a general matter, we seek to protect our interests by entering into confidentiality agreements with our employees, consultants and potential business partners, we may not be able to adequately protect our trade secrets or other proprietary information.

Others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets.

Our drug discovery, development and commercialization activities face, and will continue to face, intense competition from organizations such as pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies.

We face significant competition from organizations, particularly fully integrated pharmaceutical companies, that are pursuing pharmaceuticals that are competitive with JAKAFI, ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, OPZELURA, ZYNYZ and our drug candidates.

Many companies and institutions, either alone or together with their collaborative partners, have substantially greater financial resources, larger drug discovery, development and commercial staffs and significantly greater experience than we do in:

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• manufacturing, marketing, distributing and selling products.

Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA and other regulatory approval or commercializing products that compete with JAKAFI, ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, OPZELURA, ZYNYZ or our drug candidates.

In addition, any drug candidate that we successfully develop may compete with existing therapies that have long histories of safe and effective use.

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This foreign regulatory approval process involves all of the risks associated with FDA approval discussed above and may also include additional risks.

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-US countries prior to the commencement of clinical trials or marketing of the product in those countries.

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S.

countries prior to the commencement of clinical trials or marketing of the product in those countries.

Certain countries outside of the United States have a process that requires the submission of a clinical trial application, or CTA, much like an IND prior to the commencement of human clinical trials.

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Our manufacturing strategy is to contract with third parties to manufacture the raw materials, our active pharmaceutical ingredients, or API, and finished dosage form for clinical and commercial uses.

We currently do not operate manufacturing facilities for clinical or commercial production of JAKAFI, ICLUSIG, PEMAZYRE, OPZELURA, MONJUVI/MINJUVI and ZYNYZ or our drug candidates.

We currently do not operate manufacturing facilities for clinical or commercial production of JAKAFI, ICLUSIG, PEMAZYRE, OPZELURA, MONJUVI/MINJUVI, ZYNYZ and NIKTIMVO or our drug candidates.

As such, we expect to continue to rely on third parties for the manufacture of commercial supplies of the raw materials, API and finished drug product for drugs that we successfully develop and are approved for commercial sale.

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The Yverdon facility started to manufacture MONJUVI/MINJUVI drug substance during the fourth quarter of 2022.

The drug substance will be usable in patients after regulatory approval, which is currently expected in the first quarter of 2024 for the European market and in the first quarter of 2025 in the United States.

The drug substance is usable in patients after regulatory approval, which was granted in the fourth quarter of 2023 for the European market and is currently expected in the second quarter of 2025 in the United States.

Manufacturing of our Products

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Establishing and managing the supply chain requires a significant financial commitment and the creation and maintenance of numerous third-party contractual relationships.

We contract with third parties to manufacture JAKAFI, ICLUSIG, MONJUVI/MINJUVI, PEMAZYRE, OPZELURA, ZYNYZ and our drug candidates for clinical and commercial purposes.

We contract with third parties to manufacture JAKAFI, ICLUSIG, MONJUVI/MINJUVI, PEMAZYRE, OPZELURA, ZYNYZ, NIKTIMVO and our drug candidates for clinical and commercial purposes.

Third-party manufacturers supply raw materials, and other third-party manufacturers convert these raw materials into API or convert the API into final dosage form.

For most of our drug candidates, once our raw materials are produced, we rely on one third-party to manufacture the API, another to make finished drug product and a third to package and label the finished product.

For ruxolitinib phosphate, the API for JAKAFI and OPZELURA, we have two qualified third-party contract manufacturers from which we can source drug substance.

For ruxolitinib phosphate, the API for JAKAFI and OPZELURA, we have three qualified third-party contract manufacturers from which we can source drug substance, one of which is currently active.

The manufacturing of ponatinib, the API for ICLUSIG, is the sole responsibility of Takeda, the intellectual property holder.

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For PEMAZYRE, we have one qualified third-party manufacturer from which we can source commercial drug product.

For OPZELURA, we have one qualified third-party manufacturer from which we can source commercial drug product.

For OPZELURA, we have two qualified third-party manufacturer from which we can source commercial drug product for the United States market, and one qualified third-party manufacture from which we can source commercial drug product for markets outside of the United States.

We may not be able to obtain sufficient quantities of any of our raw materials, drug candidates, API, or finished goods if our designated manufacturers do not have the capacity or capability to manufacture our products according to our schedule and specifications.

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We post all of our open positions on the Historically Black Colleges and Universities career pages and participate in diversity career fairs with national organizations such as the National Black MBA Association, National Organization for the Professional Advancement of Black Chemists & Chemical Engineers (NOBBChE) and National Sales Network to expand our recruitment reach.

As part of our ESG goals in our 2023 incentive compensation plan, we aspire to ensuring that a minimum rate of 75% of all open positions being recruited in the United States have at least one Black or Hispanic candidate represented in the candidate pool.

We offer what we believe is a competitive compensation package, which allows 100% of global Incyte employees to participate in our annual incentive compensation plan as well as annual equity-based grants.

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As of December 31, 2024, we had 2,617 employees, representing an increase of approximately 4% over our 2,524 employees as of the end of the prior year.

This growth is largely a result of continued expansion of our global commercial reach for the launch of OPZELURA (ruxolitinib) cream.

This growth is largely a result of continued expansion of our global commercial reach for our business operations.

Among our employees, 896 are in research and development, 212 in medical affairs, 807 in sales and marketing and 702 in operations support and administrative positions.

Geographically, 72% of our employees were based in the United States and Canada, 26% in Europe and 2% in Asia.

In terms of gender diversity, 1,301 are female, 1,216 are male and seven are non-binary/prefer not to say.

Our employees in Belgium and Spain are covered by collective agreements, and management considers relations with our employees to be good.

In terms of gender diversity, 1,341 are female, 1,260 are male and 16 are non-binary/prefer not to say.

Our employees in Austria, Belgium and Spain are covered by collective agreements, and management considers relations with our employees to be good.

Available Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business