Marginal zone lymphoma refractory

BEIJING--( BUSINESS WIRE )--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2024 interim results and corporate update as of 30 June 2024. Revenue of orelabrutinib increased by 30.0% year-on-year (YoY) to RMB417.0 million in the first half of 2024, with a YoY growth of 48.8% in the second quarter. This is attributed to the rapid growth of marginal zone lymphoma (MZL) as well as effective sales execution. The Loss decreased by 37.6% YoY to RMB268.0 million in the first half of 2024. Cash and Related Accounts Balance stood at about RMB7.99 billion as of 30 June 2024. This robust cash position provides the Company with flexibility to expedite clinical development and invest in a competitive pipeline. Gross Profit increased by 19.3% to RMB359.6 million in the first half of 2024. Gross profit margin was 85.7%, representing an increase of 5.8 percentage points, which was primarily due to the sales combination change of drugs and service. Research and Development Expenses increased by 17.5% 1 to RMB420.8 million in the first half of 2024 primarily due to mainly due to more resources to increased investment in advanced technology platform innovation and Phase III clinical trials aimed at accelerating the Group’s transformation. Total Revenue reached RMB419.7 million in the first half of 2024, which was primarily attributable to rapid ramp-up of orelabrutinib sales volume. All three approved indications of orelabrutinib, including relapsed and refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), relapsed and refractory mantle cell lymphoma (r/r MCL) and relapsed and/or refractory marginal zone lymphoma (r/r MZL) have been covered under the updated National Reimbursement Drug List (NRDL) 2023. Orelabrutinib has been approved as the first and only BTK inhibitor for r/r MZL in China. Orelabrutinib was officially included as a class I recommended regimen for the treatment of r/r MZL patients in the 2024 Chinese Society of Clinical Oncology (CSCO) Guidelines. The Company’s commercial capabilities have undergone significant enhancements, including an optimized and upgraded commercial team, which has developed more executable strategies. The dedicated team has been optimized to operate with heightened efficiency and strategic focus, ensuring effective execution of market initiatives. This optimization has bolstered the team’s ability to penetrate markets swiftly and effectively. These advancements underscore InnoCare’s commitment to delivering value and driving sustainable growth in the Company’s commercial endeavors. Benefiting Patients Worldwide Entering InnoCare version 2.0, the Company is continuing to strengthen the entire value chain and rapidly advance the clinical trials of its pipeline. Over the next three to five years, five to six innovative drugs are expected to be approved for marketing, addressing unmet treatment needs and benefiting patients worldwide. Becoming a Leading Player in Hemato-Oncology Hemato-oncology, including lymphoma, leukemia, and myeloma, is known for its high mortality rates. InnoCare is dedicated to developing therapeutics with diverse mechanisms of action (MoA) to achieve comprehensive coverage of blood tumor indications, with the aspiration of becoming a leader in this field. Beyond the approved indications, InnoCare is advancing the first line registrational clinical trials and new drug application (NDA) for orelabrutinib. Tafasitamab (CD19 monoclonal antibody), another key product, is expected to be approved for marketing in the first half of next year, further strengthening the Company's market presence. InnoCare is also accelerating the development of BCL2 inhibitor ICP-248, which has significant combination synergy with orelabrutinib. Notably, BCL2 inhibitors are the preferred therapeutic option following resistance to BTK inhibitors, creating an optimal sequential treatment strategy. With these assets in the pipeline, along with the molecule glue ICP-490, monoclonal antibody ICP-B05 and bispecific antibody ICP-B02, and potential future developments from internal and external sources, the Company is aimed at becoming a leading player in hemato-oncology both in China and worldwide. Orelabrutinib The clinical trial of orelabrutinib in combination with ICP-248, a BCL2 inhibitor developed by InnoCare, for first-line treatment of CLL/SLL was initiated in May of this year, and patient enrollment of the Phase II trial has been completed as of this announcement . The Company is accelerating the registrational trials and NDA of the first line indications of orelabrutinib, including CLL/SLL, SCL and diffuse large B-cell lymphoma (DLBCL). Orelabrutinib continues to gain attention from top international academic conferences. Five studies of orelabrutnib were selected for the European Society for Medical Oncology (ESMO) Congress 2024, with a prospective study of orelabrutinib regimen in treatment-naive MZL as an oral presentation at the conference. 10 studies on orelabrutinib have been selected for the European Hematology Association (EHA) 2024 Hybrid Congress. Tafasitamab The biologics license application (BLA) for tafasitamab in combination with lenalidomide for adult patients with r/r DLBCL who are not eligible for Autologous Stem Cell Transplant (ASCT) was accepted and granted priority review in China in June 2024. DLBCL is the most common type of non-Hodgkin’s lymphoma (NHL), accounting for 31%~34% of NHL patients globally. In China, DLBCL accounts for 45.8% of all NHLs 2 . Tafasitamab regimen was approved by the Department of Health, the Hong Kong Special Administrative Region, China, and approved for use in Bo’ao and Greater Bay Area with first prescription issued respectively. ICP-248 ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor. The clinical trial of ICP-248 in combination with orelabrutinib for first line (1L) CLL/SLL was initiated, and patient enrollment for the Phase II trial has been completed. So far, 47 patients have been dosed, and among 28 evaluable patients with BTK inhibitor failure r/r MCL, the overall response rate (ORR) was 71.4% . The investigational new drug (IND) filing for ICP-248 for Acute Myeloid Leukemia (AML) has been accepted by the CDE . ICP-490 Developed from InnoCare's molecular glue platform, ICP-490 shows strong potential to revolutionize the treatment of MM, NHL, and other hemato-oncology indications, whether as a monotherapy or in combination with other therapies. The Phase I dose escalation study is ongoing in China with multiple myeloma (MM) and NHL patients , demonstrating a good tolerability and safety profile. This safety profile has supported the decision to continue dose escalation to the next dosage level. ICP-B02 (CM355) ICP-B02 is a CD20xCD3 bispecific antibody co-developed with Keymed. Data from both the intravenous infusion (IV) and the subcutaneous (SC) formulations have shown good efficacy of ICP-B02 in patients with follicular lymphoma (FL) and DLBCL. All 15 patients who were treated with ICP-B02 at doses ≥6mg achieved response, resulting in an ORR of 100% . All patients who achieved CR maintained the remission as of the cutoff date. Based on the encouraging results of ICP-B02 as a single agent, the Company is planning for a dose expansion study of ICP-B02 in combination with other immunochemotherapies targeting earlier lines of treatment in NHL patients. The IND application for the combination therapies was approved in China in June 2024. ICP-B05 (CM369) ICP-B05 (CM369) is a potential first-in-class anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers. The Phase I trial is ongoing, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of ICP-B05 in subjects with advanced solid tumors and r/r NHL. Preliminary efficacy was observed in NHL patient . ICP-B05 was well tolerated with no dose-limiting toxicities (DLTs). Advancing Research and Development in Solid Tumors InnoCare strives to expand the breadth of its pipeline to cover solid tumor diseases areas through a combination of targeted therapy and immune-oncology approaches. The Company believes that potential best-in-class molecule, zurletrectinib (ICP-723), will enable InnoCare to establish a solid footprint in the field of solid tumor treatment. To benefit a broader range of patients, InnoCare’s rapidly maturing early-stage pipeline, including the cornerstone therapy ICP-189 and ICP-B05 immune-oncology treatment, aims to offer competitive treatment solutions for a large array of solid tumors, both in China and worldwide. Zurletrectinib (ICP-723) The fusion mutation of NTRK gene is a carcinogenic factor for many cancers, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma . Zurletrectinib is a second generation TRK inhibitor developed by InnoCare. The Company is accelerating the registrational trial of zurletrectinib in China, which has entered the pre-NDA stage . Zurletrectinib has demonstrated good efficacy and safety profile. It was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy. The clinical study with zurletrectinib has covered neurotrophic tyrosine receptor kinase (NTRK) gene fusion adult patients, adolescent patients (12 to 18 years old) and pediatric patients (2 to 12 years old). The efficacy has been observed in both adolescent and pediatric patients. The dose escalation trial for pediatric patients has been completed. ICP-189 The novel SHP2 allosteric inhibitor, ICP-189, is being developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. The clinical trial of the combination of InnoCare’s lCP-189 with ArriVent’s third generation EGFR inhibitor furmonertinib in patients with advanced non-small cell lung cancer (NSCLC) is ongoing, with the preliminary efficacy observed. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases 3 . Preliminary efficacy was observed in ICP-189 monotherapy. As a potential first-in-class SHP2 inhibitor, ICP-189 is an ideal partner for combination with multiple targeted and immune-oncology therapies in solid tumors. ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRAS G12C mutation and Epidermal Growth Factor Receptor (EGFR) over-expression. The SHP2 combination therapy provides a promising treatment option for NSCLC patients who are resistant to the third generation EGFR inhibitors. As of this announcement, the study of the 120mg QD group has been completed, with no DLT observed, and it has shown a favorable PK profile with a long half-life. The patient enrollment at 160mg QD is ongoing. InnoCare is also actively exploring preclinical development in solid tumors, and developing small molecule and large molecule innovative drugs by building a differentiated platform for the treatment of solid tumors such as lung cancer and gastric cancer, so as to meet huge unmet medical needs. Comprehensive Coverage in Autoimmune Diseases Autoimmune diseases can affect almost every organ in the body and can occur at any age. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 2029 4 . The Company has fortified its powerful discovery engine focusing on global frontier targets for the development of differentiated autoimmune therapeutics through B-cell and T-cell pathways, aiming to offer first-in-class or best-in-class treatments to the massive unmet medical needs with promising market potential worldwide and/or regionally. Orelabrutinib ITP: The Company has achieved proof of concept (PoC) for orelabrutinib in the treatment of primary immune thrombocytopenia purpura (ITP), and has completed enrollment of over 50% of patients in the Phase III registrational trial. The annual incidence rate of adult ITP is about 2-10 per 100,000 people 5 . Only about 70% of patients respond to first-line treatment. Orelabrutinib has potential to provide a better treatment option for ITP patients 6 . From blood tumor to autoimmune diseases in the hematological field, orelabrutinib will demonstrate its huge commercial potential. The ITP Phase II result was published by the American Journal of Hematology in April 2024. For details, please refer to https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/ajh.27303 . SLE: The Phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, with remarkable SLE Responder Index (SRI)-4 response rates observed in a dose dependent manner, along with trends indicating a reduction in proteinuria levels. Orelabrutinib is global first and only BTK inhibitor ever shown efficacy in Phase II SLE trials. A Phase IIb trial is ongoing, and the patients enrollment has been nearly completed as of this announcement . SLE is a systemic disease that often leads to damage to organs, especially the kidneys and nervous system, skin, blood system, respiratory system, and almost all systems may be affected. According to Frost Sullivan analysis, it is expected that there will be 8.18 million SLE patients worldwide by 2025. The Chinese Systemic Lupus Erythematosus Development Report 2020 points out that there are about one million SLE patients in China, ranking first in the world in number of patients and second in incidence rate. ICP-332 ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including atopic dermatitis (AD), vitiligo, inflammatory bowel disease, etc., with broad market prospects. The latest data of ICP-332 for the treatment of patients with moderate-to-severe AD has been released at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation. ICP-332 achieved multiple efficacy endpoints in the China Phase II study for the treatment of patients with moderate-to-severe AD, demonstrating an outstanding efficacy and safety profile. ICP-332 showed better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison). In the ICP-332 80 mg once-daily (QD) and 120 mg QD groups for four weeks, the response rates of EASI 90 (improvement of at least 90% in EASI score from baseline) and NRS (Pruritus Numerical Rating Scale) score from baseline ≥4 points demonstrated a 40% and 56% improvement respectively compared with the placebo group, both of which were superior to competitors. ICP-332 was safe and well tolerated in AD patients. The overall incidence rates of adverse events (AEs) in the two treatment groups were comparable to that of the placebo group. The Company expects to start the patient enrollment of the Phase III trial for AD in China in the fourth quarter of 2024, and to submit IND for the Phase II/III trial for a second indication of vitiligo. The US trials have been initiated . ICP-488 Data shows that 100 million people worldwide are affected by various types of psoriasis 7 . ICP-488 is a potent and selective TYK2 allosteric inhibitor that binds to the pseudo kinase JH2 domain of TYK2 and blocks IL-23, IL12, type 1 IFN, and other cytokine receptors. The Phase II study of ICP-488 in psoriasis has completed patient enrollment in May 2024. The Company expects the data readout by the end of 2024 . A total of 129 patients were enrolled in this study. Patients were randomly assigned to two treatment groups and placebo group, for 12 consecutive weeks of treatment. ICP-488 demonstrated good efficacy and safety in the Phase I study of ICP-488 in psoriasis patients. Novel Small Molecule Inhibitor of IL-17 IL-17 is a pro-inflammatory cytokine that plays an important role in immune functional responses. Orally administered small molecules targeting IL-17 may represent a convenient alternative to IL-17-targeting monoclonal antibodies for patients. This novel orally available small molecule can potently block the binding of both IL-17AA and IL-17AF to IL-17R. Dr. Jasmine Cui , the Co-founder, Chairwoman and CEO of InnoCare, said, "In the first half of 2024, our commercial team exceeded pre-set goals, with a significant increase in revenue. We have developed innovative drugs with huge unmet medical needs, with three NDAs submitted in the first half of this year. We have also been actively exploring preclinical innovation, laying a solid foundation for future development. Looking ahead to the second half of the year, we will continue to make concerted efforts in the fields of new drug R&D, clinical development, commercialization and globalization, focusing on key goals to achieve high-quality development.” To know more about the detailed financial data and business updates of InnoCare 2024 annual results, please log in to https://www.innocarepharma.com/en/investor/home . Conference Call Information InnoCare will host a conference call at 9:30 a.m. Beijing time on August 21 in Chinese and at 8:30 p.m. Beijing time in English on August 21, 2024. Participants must register in advance of the conference call. Details are as follows: For English conference call, please register through the below link: https://ubs-innocare-h124-earnings-call.open-exchange.net/ For Chinese conference call, please register through the below link: https://s.comein.cn/AHJAP Forward-looking Statement This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. ___________________________________ 1 Based on HKFRS (Hongkong Financial Reporting Standards) 2 Hematology Branch of Chinese Medical Association 3 Journal of Clinical Oncology，IF: 50.717 4 iHealthcareAnalyst, Inc., Oct. 3, 2023 5 Adult ITP Guidelines (2020 Edition) 6 Poster at the 63rd ASH Annual Meeting (Abstract Number: 3172) 7 Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021.

WILMINGTON, Del.--( BUSINESS WIRE )--Incyte (Nasdaq:INCY) today reports 2024 second quarter financial results, and provides a status update on the Company’s clinical development portfolio. "In the second quarter of 2024, total revenues grew 9% year-over-year, surpassing $1.0 billion for the quarter. The commercial performance during this period was driven by strong patient demand for Opzelura ® (ruxolitinib) and growth across all indications for Jakafi ® (ruxolitinib)," said Hervé Hoppenot, Chief Executive Officer, Incyte. "In R&D, we completed a strategic review of our pipeline and have further intensified our focus on clinical programs that we believe can be transformational for patients. The $2.0 billion share repurchase completed during the second quarter, underscores our confidence in our commercial portfolio, clinical pipeline and Incyte's long-term value." Transformation of Pipeline Incyte announces a strategic review of its pipeline with an increased focus on high potential impact programs including, but not limited to: IAI/Dermatology : povorcitinib and MRGPRX2 and MRGPRX4, which were recently acquired from Escient Pharmaceuticals MPNs/GVHD : mCALR, JAK2V617Fi, BETi, and ALK2i Oncology : CDK2i, KRASG12Di and TGFßR2×PD-1 The Company will discontinue further development of both oral, small molecule PD-L1 inhibitors, as well as LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific. Recent Company Updates Incyte announces positive topline results from two Phase 3 clinical studies evaluating retifanlimab (Zynyz ® ), a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC). The Phase 3 PODIUM-303 study in SCAC met its primary endpoint of progression free survival and the Phase 3 PODIUM-304 study in NSCLC met its primary endpoint of overall survival. The safety analysis from both studies demonstrated that retifanlimab was generally well-tolerated with no new safety signals observed. Incyte plans to share the Phase 3 data from both studies in the second half of 2024. 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 June 2024, Incyte repurchased a total of 33,325,849 shares of its common stock at a price of $60.00 per share, for a total cost of approximately $2.0 billion, excluding fees and expenses. These shares represented approximately 14.8 percent of the Company’s total outstanding shares of common stock as of June 7, 2024. In May 2024, Incyte announced it completed the acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders. Under the terms of the agreement, Incyte acquired Escient and its clinical development portfolio, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist. In April 2024, Incyte and China Medical System Holdings Limited announced the Companies entered into a Collaboration and License Agreement, through a wholly-owned dermatology medical aesthetic subsidiary CMS Skinhealth, for the development and commercialization of povorcitinib, a selective oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan Region and eleven Southeast Asian countries. Jakafi: Net product revenues for the second quarter 2024 of $706 million (+3% Y/Y): Paid demand increased 9% in the second quarter of 2024 versus the same quarter in the prior year, with growth across all indications. Year over year net product revenue growth was lower than paid demand growth due to higher channel inventory levels at the end of the second quarter of 2023 versus the same period of 2024. Channel inventory at the end of the second quarter of 2024 was within the normal range. Opzelura: Net product revenues for the second quarter 2024 of $122 million (+52% Y/Y): Net product revenues growth in the second quarter of 2024 were driven by patient demand, refills and expansion in payer coverage in both atopic dermatitis (AD) and vitiligo. Net product revenues of $11 million in the second quarter of 2024 in Europe. Incyte achieved full reimbursement in Spain and Italy at the end of the second quarter 2024 and in France in July 2024. Additional Pipeline Updates Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights Combination trials of ruxolitinib twice daily (BID) with zilurgisertib and BETi are ongoing and continue to enroll. A Phase 3 study for BETi is expected to advance into Phase 3 with an expected update later this year. Clinical proof-of-concept for zilurgisertib is anticipated in the second half of 2024. The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies is anticipated in 2025. MPN and GVHD Programs Indication and status Ruxolitinib XR (QD) (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2i) Myelofibrosis: Phase 2 Ruxolitinib + INCB57643 (JAK1/JAK2 + BETi) Myelofibrosis: Phase 2 Axatilimab (anti-CSF-1R) 1 Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201); BLA under review in the U.S. Ruxolitinib + axatilimab 1 (JAK1/JAK2 + anti-CSF-1R) Chronic GVHD: Phase 2 in preparation Steroids + axatilimab 1 (Steroids + anti-CSF-1R) Chronic GVHD: Phase 3 in preparation INCA33989 (mCALR) Myelofibrosis, essential thrombocythemia: Phase 1 INCB160058 (JAK2V617Fi) Phase 1 1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. Other Hematology/Oncology – key highlights Heme/Oncology Programs Indication and status Pemigatinib (Pemazyre ® ) (FGFR1/2/3) Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302) Tafasitamab (Monjuvi ® /Minjuvi ® ) (CD19) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 ( front MIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 ( in MIND) Retifanlimab (Zynyz ® ) 1 (PD-1) Merkel cell carcinoma (MCC): approved in the U.S. and Europe Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) INCB123667 (CDK2i) Solid tumors with Amplification/ Overexpression of CCNE1: Phase 1 INCB161734 (KRASG12D) Advanced metastatic solid tumors with a KRAS G12D mutation: Phase 1 INCA33890 (TGFßR2×PD-1) 2 Advanced or metastatic solid tumors: Phase 1 1 Retifanlimab licensed from MacroGenics. 2 Development in collaboration with Merus. Inflammation and Autoimmunity (IAI) – key highlights Dermatology Opzelura In March 2024, Incyte presented data at the 2024 AAD Annual Meeting from its randomized, placebo-controlled, Phase 2 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura ® ) in adults with mild/moderate hidradenitis suppurativa (HS). At Week 16, patients receiving ruxolitinib cream 1.5% twice daily (BID) had significantly greater decreases from baseline versus placebo in total abscess and inflammatory nodule (AN) count, the primary endpoint of the study. The overall safety profile of ruxolitinib cream was consistent with previous data, and no new safety signals were observed. A Phase 3 study is expected to initiate in 2025. Ruxolitinib cream in other indications: Phase 2 studies in lichen planus and lichen sclerosus have completed enrollment. Two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing. Povorcitinib (INCB54707) The Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN were presented at the 2024 AAD Annual Meeting with the study meeting its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, reinforcing povorcitinib’s potential role in treating PN. A Phase 3 study in PN is expected to initiate in 2024. Two Phase 2 trials in asthma and chronic spontaneous urticaria are enrolling. IAI and Dermatology Programs Indication and status Ruxolitinib cream (Opzelura ® ) 1 (JAK1/JAK2) Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3) Vitiligo: Approved in the U.S. and Europe Lichen planus: Phase 2 Lichen sclerosus: Phase 2 Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025 Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) Ruxolitinib cream + UVB (JAK1/JAK2 + phototherapy) Vitiligo: Phase 2 Povorcitinib (JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 3 (STOP-V1, STOP-V2) Prurigo nodularis: Phase 3 expected to initiate in 2024 Asthma: Phase 2 Chronic spontaneous urticaria: Phase 2 INCB000262 (EP262) (MRGPRX2) Chronic spontaneous urticaria: Phase 2 Chronic inducible urticaria: Phase 1b Atopic dermatitis: Phase 2a INCB000547 (EP547) (MRGPRX4) Cholestatic pruritus: Phase 2a INCA034460 (anti-IL-15Rβ) Vitiligo: Phase 1 1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. Other Other Program Indication and Phase Zilurgisertib (ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2 Partnered Partnered Programs Indication and Phase Ruxolitinib (Jakavi ® ) 1 (JAK1/JAK2) Acute and chronic GVHD: Approved in Europe and Japan Baricitinib (Olumiant ® ) 2 (JAK1/JAK2) AD: Approved in Europe and Japan Severe alopecia areata (AA): Approved in the U.S., Europe and Japan Capmatinib (Tabrecta ® ) 3 (MET) NSCLC (with MET exon 14 skipping mutations): Approved in the U.S., Europe and Japan 1 Ruxolitinib (Jakavi ® ) licensed to Novartis ex-U.S. for use in hematology and oncology excluding topical administration. 2 Baricitinib (Olumiant ® ) licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis. 3 Capmatinib (Tabrecta ® ) licensed to Novartis. 2024 Second Quarter Financial Results The financial measures presented in this press release for the three and six months ended June 30, 2024 and 2023 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Total GAAP revenues $ 1,043,759 $ 954,610 $ 1,924,648 $ 1,763,283 Total GAAP operating (loss) income (478,130 ) 193,780 (386,232 ) 218,550 Total Non-GAAP operating (loss) income (378,801 ) 262,058 (217,618 ) 351,787 GAAP net (loss) income (444,601 ) 203,548 (275,053 ) 225,251 Non-GAAP net (loss) income (396,132 ) 223,029 (263,413 ) 307,606 GAAP basic EPS $ (2.04 ) $ 0.91 $ (1.24 ) $ 1.01 Non-GAAP basic EPS $ (1.82 ) $ 1.00 $ (1.19 ) $ 1.38 GAAP diluted EPS 1 $ (2.04 ) $ 0.90 $ (1.24 ) $ 1.00 Non-GAAP diluted EPS 1 $ (1.82 ) $ 0.99 $ (1.19 ) $ 1.36 1. All stock options and stock awards were excluded from the diluted share calculation for the three and six months ended June 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position. Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended June 30, % Change (as reported) % Change (constant currency) 1 Six Months Ended June 30, % Change (as reported) % Change (constant currency) 1 2024 2023 2024 2023 Net product revenues: Jakafi $ 705,973 $ 682,384 3 % 3% $ 1,277,812 $ 1,262,353 1 % 1% Opzelura 121,695 80,233 52 % 52% 207,419 136,785 52 % 52% Iclusig 26,862 29,087 (8 %) (7%) 57,205 56,772 1 % —% Pemazyre 20,269 21,572 (6 %) (6%) 37,945 44,047 (14 %) (14%) Minjuvi/ Monjuvi 31,116 13,159 136 % 137% 54,990 19,715 179 % 179% Zynyz 651 570 14 % NM 1,118 570 96 % NM Total net product revenues 906,566 827,005 10 % 10% 1,636,489 1,520,242 8 % 8% Royalty revenues: Jakavi 99,317 90,448 10 % 14% 188,912 167,140 13 % 16% Olumiant 31,702 32,009 (1 %) 4% 62,291 66,164 (6 %) (3%) Tabrecta 5,298 4,799 10 % NA 10,532 8,976 17 % NA Pemazyre 876 349 151 % NM 1,424 761 87 % NM Total royalty revenues 137,193 127,605 8 % 263,159 243,041 8 % Total net product and royalty revenues 1,043,759 954,610 9 % 1,899,648 1,763,283 8 % Milestone and contract revenues — — — % —% 25,000 — NM NM Total GAAP revenues $ 1,043,759 $ 954,610 9 % $ 1,924,648 $ 1,763,283 9 % NM = not meaningful NA = not available 1. Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results. Product and Royalty Revenues Product revenues and product and royalty revenues for the quarter ended June 30, 2024 increased 10% and 9%, respectively, over the prior year comparative period, primarily driven by the following; Jakafi net product revenue increased 3% driven by a 9% increase in paid demand. Year over year net product revenue growth was lower than paid demand growth due to higher channel inventory levels at the end of the second quarter of 2023 versus the same period of 2024. Channel inventory at the end of the second quarter of 2024 was within the normal range. Opzelura net product revenue increased 52% due to continued growth in new patient starts and refills. Minjuvi/Monjuvi net product revenue increased 136% following the acquisition of the exclusive global rights to tafasitamab in February 2024. Jakavi royalty revenues increased 10%. Operating Expenses Operating Expense Summary (unaudited, in thousands) Three Months Ended June 30, % Change Six Months Ended June 30, % Change 2024 2023 2024 2023 GAAP cost of product revenues $ 76,634 $ 68,326 12 % $ 137,590 $ 125,148 10 % Non-GAAP cost of product revenues 1 70,899 62,150 14 % 125,858 112,819 12 % GAAP research and development 1,138,380 400,750 184 % 1,567,640 807,391 94 % Non-GAAP research and development 2 1,089,089 367,921 196 % 1,477,526 743,541 99 % GAAP selling, general and administrative 305,982 283,929 8 % 606,238 599,535 1 % Non-GAAP selling, general and administrative 3 262,572 263,030 — % 539,907 557,047 (3 %) GAAP (gain) loss on change in fair value of acquisition-related contingent consideration 893 8,374 (89 %) 437 14,570 (97 %) Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration 4 — — — % — — — % GAAP (profit) and loss sharing under collaboration agreements — (549 ) — % (1,025 ) (1,911 ) (46 %) 1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. 2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. 3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. 4 Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration is null. Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended June 30, 2024 increased 12% and 14%, respectively, compared to the same period in 2023 primarily due to growth in net product revenues. Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2024 increased 184% and 196%, respectively, compared to the same period in 2023 primarily due to $679.4 million of expense relating to the IPR&D assets acquired in the Escient acquisition, $12.5 million of Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments, as well as continued investment in our late stage development assets. Excluding the upfront consideration paid related to the Escient transaction and other upfront and milestone payments, research and development expense for the quarter ended June 30, 2024 increased 13% compared to the same period in 2023 due to continued investment in our late stage development assets and timing of certain expenses. Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter ended June 30, 2024 increased 8% compared to the same period in 2023 primarily due to $21.5 million of Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments and timing of consumer marketing activities and of certain other expenses. Excluding the upfront consideration paid related to the Escient transaction, selling, general and administrative expenses for the quarter ended June 30, 2024 were flat compared to the same period in 2023. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2024, compared to the same period in 2023, was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig. Operating income GAAP and Non-GAAP operating income for the three months ended June 30, 2024 decreased 347% and 245%, respectively, compared to the same period in 2023, driven primarily by the aforementioned costs relating to the Escient acquisition. Provision for income taxes The income tax expense for the three months ended June 30, 2024 was $54.8 million on a pre-tax loss of $389.8 million primarily due to the impact of non-tax deductible charges of $710.9 million associated with the acquisition of Escient. Cash, cash equivalents and marketable securities position As of June 30, 2024 and December 31, 2023, cash, cash equivalents and marketable securities totaled $1.4 billion and $3.7 billion, respectively. The decrease in cash, cash equivalents and marketable securities during 2024 was driven primarily by the $2.0 billion share repurchase completed during June 2024, and the total cash consideration paid to Escient shareholders of $783 million. Share Repurchase In June 2024, Incyte completed a $2.0 billion share repurchase reflecting our confidence in the future outlook of our business, the strength of our commercial portfolio and the clinical development pipeline. In total, approximately 33.3 million shares of common stock were repurchased at $60.00 per share and represented approximately 14.8% of our common shares outstanding at the time of the repurchase. As of June 30, 2024, there were 191.6 million common shares outstanding. 2024 Financial Guidance Incyte is raising the low end of its full year 2024 Jakafi revenue guidance as well as updating its full year 2024 research and development guidance to reflect the ongoing impact of the acquisition of Escient Pharmaceuticals. The research and development guidance excludes $691 million of upfront consideration recorded relating to the acquisition of Escient Pharmaceuticals. Incyte is maintaining its full year 2024 other hematology/oncology revenue guidance, as well as its cost of product revenue and selling, general and administrative guidance. Incyte’s guidance is summarized below. Guidance does not include revenue from any potential new product launches or the impact of any potential future strategic transactions. Current Previous Jakafi net product revenues $2,710 - $2,750 million $2,690 - $2,750 million Other Hematology/Oncology net product revenues (1) Unchanged $325 - $360 million GAAP Cost of product revenues Unchanged 7 – 8% of net product revenues Non-GAAP Cost of product revenues (2) Unchanged 6 – 7% of net product revenues GAAP Research and development expenses $1,755 - $1,800 million $1,720 - $1,760 million Non-GAAP Research and development expenses (3) $1,615 - $1,655 million $1,580 - $1,615 million GAAP Selling, general and administrative expenses Unchanged $1,210 - $1,240 million Non-GAAP Selling, general and administrative expenses (3) Unchanged $1,115 - $1,140 million 1 Pemazyre in the U.S., EU and Japan; Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU. 2 Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. 3 Adjusted to exclude the estimated cost of stock-based compensation. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13747471. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13747471. The conference call will also be webcast live and can be accessed at investor.incyte.com . About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn , X , Instagram , Facebook , YouTube . About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Opzelura ® (ruxolitinib) Cream Opzelura ® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) 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. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte . About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration 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). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are (registered) trademarks of Incyte. About Pemazyre ® (pemigatinib) Pemazyre ® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre and the Pemazyre logo are registered trademarks of Incyte. * Pemazyre ® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Iclusig ® (ponatinib) tablets Ponatinib (Iclusig ® ) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz ® (retifanlimab-dlwr) Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz and the Zynyz logo are registered trademarks of Incyte. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for continued performance and growth; Incyte’s financial guidance for 2024, including its expectations regarding sales of Jakafi; expectations regarding demand for and sales of Opzelura, among other products; expectations regarding reimbursement for Opzelura in Europe; where we intend to focus R&D efforts; plans to deliver sustainable innovation through 2028 and beyond; expectations regarding the potential and progress of our pipeline, including expectations for ruxolitinib cream, povorcitinib, INCB000262, INCB000547, axatilimab, mCALR, JAK2V617Fi, retifanlimab, INCB123667, KRASG12Di and our TGF-β program; Incyte’s ability to develop new transformative therapies to treat myeloid disease and cure MPNs; expectations regarding ongoing clinical trials and clinical trials to be initiated; expectations regarding data flow/readouts; expectations regarding regulatory filings, potential regulatory approvals and potential product launches; and expectations regarding 2024 newsflow items. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the possibility that results of clinical trials will be negative and/or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by FDA, EMA, and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the supply of and/or demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 GAAP GAAP Revenues: Product revenues, net $ 906,566 $ 827,005 $ 1,636,489 $ 1,520,242 Product royalty revenues 137,193 127,605 263,159 243,041 Milestone and contract revenues — — 25,000 — Total revenues 1,043,759 954,610 1,924,648 1,763,283 Costs, expenses and other: Cost of product revenues (including definite-lived intangible amortization) 76,634 68,326 137,590 125,148 Research and development 1,138,380 400,750 1,567,640 807,391 Selling, general and administrative 305,982 283,929 606,238 599,535 Loss on change in fair value of acquisition-related contingent consideration 893 8,374 437 14,570 (Profit) and loss sharing under collaboration agreements — (549 ) (1,025 ) (1,911 ) Total costs, expenses and other 1,521,889 760,830 2,310,880 1,544,733 (Loss) income from operations (478,130 ) 193,780 (386,232 ) 218,550 Interest income and other, net 49,769 42,668 94,513 75,541 Interest expense (657 ) (655 ) (1,087 ) (1,124 ) Realized and unrealized gain on equity investments 39,241 41,811 139,188 36,493 (Loss) income before provision for income taxes (389,777 ) 277,604 (153,618 ) 329,460 Provision for income taxes 54,824 74,056 121,435 104,209 Net (loss) income $ (444,601 ) $ 203,548 $ (275,053 ) $ 225,251 Net (loss) income per share: Basic $ (2.04 ) $ 0.91 $ (1.24 ) $ 1.01 Diluted $ (2.04 ) $ 0.90 $ (1.24 ) $ 1.00 Shares used in computing net (loss) income per share: Basic 218,175 223,248 221,329 223,104 Diluted 218,175 225,649 221,329 225,541 INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) June 30, 2024 December 31, 2023 ASSETS Cash, cash equivalents and marketable securities $ 1,449,500 $ 3,656,043 Accounts receivable 739,050 743,557 Property and equipment, net 762,009 751,513 Finance lease right-of-use assets, net 25,535 25,535 Inventory 355,972 269,937 Prepaid expenses and other assets 231,504 236,782 Short and long term equity investments 99,543 187,716 Other intangible assets, net 113,536 123,545 Goodwill 155,593 155,593 Deferred income tax asset 729,561 631,886 Total assets $ 4,661,803 $ 6,782,107 LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable, accrued expenses and other liabilities $ 1,438,125 $ 1,347,669 Finance lease liabilities 32,619 32,601 Acquisition-related contingent consideration 194,000 212,000 Stockholders’ equity 2,997,059 5,189,837 Total liabilities and stockholders’ equity $ 4,661,803 $ 6,782,107 INCYTE CORPORATION RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 GAAP Net (Loss) Income $ (444,601 ) $ 203,548 $ (275,053 ) $ 225,251 Adjustments 1 : Non-cash stock compensation from equity awards (R&D) 2 34,541 32,829 71,333 63,850 Non-cash stock compensation from equity awards (SG&A) 2 21,748 20,899 44,121 42,488 Non-cash stock compensation from equity awards (COGS) 2 351 792 964 1,561 Non-cash interest 3 144 139 252 247 Realized and unrealized gain on equity investments 4 (39,241 ) (41,811 ) (139,188 ) (36,493 ) Amortization of acquired product rights 5 5,384 5,384 10,768 10,768 Loss on change in fair value of contingent consideration 6 893 8,374 437 14,570 MorphoSys transition costs 7 2,373 — 6,952 — Escient acquisition related compensation expense 8 34,039 — 34,039 — Tax effect of Non-GAAP pre-tax adjustments 9 (11,763 ) (7,125 ) (18,038 ) (14,636 ) Non-GAAP Net (Loss) Income 9 $ (396,132 ) $ 223,029 $ (263,413 ) $ 307,606 Non-GAAP net (loss) income per share: Basic $ (1.82 ) $ 1.00 $ (1.19 ) $ 1.38 Diluted 10 $ (1.82 ) $ 0.99 $ (1.19 ) $ 1.36 Shares used in computing Non-GAAP net (loss) income per share: Basic 218,175 223,248 221,329 223,104 Diluted 10 218,175 225,649 221,329 225,541 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2024 are milestones of $0 and $25,000 earned from our collaborative partners, as compared to no milestones earned for the three and six months ended June 30, 2023. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2024 are upfront consideration and milestones of $414 and $1,414, respectively, related to our collaborative partners as compared to upfront consideration and milestones of $7,000 and $9,700, respectively, for the three and six months ended June 30, 2023. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the Realized and unrealized gain on equity investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the (Gain) loss on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 Included within the Research and development line item in the Condensed Consolidated Statements of Operations is $2,232 and $6,263 for the three and six months ended June 30, 2024, respectively, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations is $141 and $689 for the three and six months ended June 30, 2024, respectively. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys. 8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations is $12,518 for the three and six months ended June 30, 2024, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations is $21,521 for the three and six months ended June 30, 2024. Escient acquisition related compensation expense represents non-recurring charges associated with (i) cash settled unvested Escient equity awards in connection with the acquisition, and (ii) severance payments to former Escient employees. 9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. The Non-GAAP net income for the three months ended March 31, 2024 should have been $132,719 compared to the $145,269 previously disclosed to correct a transposition error in the tax effect of Non-GAAP pre-tax adjustments. For the three months ended March 31, 2024, the tax effect of Non-GAAP pre-tax adjustments should have been ($6,275) instead of $6,275. 10. All stock options and stock awards were excluded from the diluted share calculation for the three and six months ended June 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position.

Arm D of SEQUOIA study evaluated treatment-naïve patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma with del(17p) and/or TP53 mutation Preliminary data suggest promising efficacy and tolerability Safety pro consistent with results of prior BRUKINSA studies SAN MATEO, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) today at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain in an oral session (Abstract S160). The presentation will feature data from arm D of SEQUOIA evaluating BRUKINSA in combination with venetoclax in treatment-naïve (TN) patients with high-risk chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation. The preliminary data demonstrate that in the 65 response-evaluable patients treated with the combination, the overall response rate (ORR) was 100%, and the rate of complete response (CR) plus CR with incomplete hematopoietic recovery (CRi) was 48%. The safety pro the combination is consistent with that of the treatment components, and no new safety signals were seen. “Patients with untreated CLL with del(17p) or TP53 mutations often face a poor prognosis, even in the front-line setting, so there is a critical need to better understand how this patient population responds to combination approaches,” said Alessandra Tedeschi, M.D., Ph.D., consultant in hematology and Medical Director of the Department of Hematology at the Niguarda Cancer Center in Milan, Italy. “This arm of the SEQUOIA study showed that zanubrutinib in combination with a BCL2 inhibitor demonstrates promising efficacy and tolerability for high-risk CLL patients, providing important information about the clinical pro this regimen.” Overall, 66 patients with centrally assessed del(17p) and/or TP53 mutation were enrolled in this arm of the SEQUOIA study. Patients received BRUKINSA at 160 mg twice daily for three months, followed by combination treatment of BRUKINSA at the same dose and venetoclax with a ramp-up dosing to 400 mg once daily for 12 to 24 cycles until progressive disease, unacceptable toxicity or confirmed undetectable minimal residual disease (MRD). In the 65 response-evaluable patients, ORR was 100%; the rate of CR+CRi was 48% (CR=46%; CRi=2%). Undetectable MRD was achieved in 59% of patients in ≥1 peripheral blood sample and with a median study follow up of 31.6 months. Median progression-free survival (PFS) was not reached; 12- and 24-month PFS estimates were 95% and 94%, respectively. “SEQUOIA has shown that BRUKINSA is a highly effective monotherapy treatment for TN CLL patients, including those with high-risk markers like del(17p) and/or TP53 mutation. With one of the largest pools of high-risk patients of any published study to date, SEQUOIA arm D demonstrates how BCL2 inhibitor therapies can complement BRUKINSA as a backbone therapy to achieve deep clinical response even in this patient population,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “We look forward to evaluating the potential for time-limited therapy with longer follow-up and incorporating these findings into our development program for our investigational next-generation BCL2 inhibitor sonrotoclax.” The safety pro BRUKINSA plus venetoclax was consistent with results of prior studies of both medicines, and no new safety signals were identified. In total, 97% of patients experienced ≥1 treatment emergent adverse effect (TEAE). The most common all-grade non-hematologic TEAEs were infections (71%), COVID-19 (55%), diarrhea (39%), nausea (30%) and contusion (29%). Grade ≥3 non-hematologic TEAEs occurred in 44% of patients; the most common were infections (15%), diarrhea (9%), hypertension (8%) and second primary malignancies (8%). The most common all grade and grade ≥3 hematologic toxicity was neutropenia (22% and 17%, respectively). The proportion of patients at high risk for tumor lysis syndrome (TLS) decreased 91% from 35% at screening to 3% after three cycles of lead-in BRUKINSA, and no TLS was reported. About SEQUOIA SEQUOIA (NCT03336333) is a randomized, multicenter, global Phase 3 trial designed to evaluate the efficacy and safety of BRUKINSA in patients with TN CLL or SLL. The trial consists of three cohorts: Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or bendamustine plus rituximab (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint; Cohort 2 (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and Cohort 3/arm D (n=114): 66 patients with del(17p) and/or pathogenic TP53 mutation received BRUKINSA in combination with venetoclax. While patients without del(17p) (n=48) were later included in this cohort, the data presented at EHA2024 do not include these patients. The results of Cohort 1 of the SEQUOIA study led to the regulatory approval of zanubrutinib monotherapy in the treatment of TN CLL in many countries across the world, including approvals by the U.S. Food and Drug Administration and the European Medicines Agency. Patients with del(17p) were not randomized in the Cohort 1 study, as these patients are known to experience poor clinical outcomes and poor response to chemoimmunotherapy, the control arm of the study. The primary endpoint of the trial is independent review committee-assessed PFS. Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed ORR, overall survival, PFS and ORR in patients with del(17p), and safety. Results for Cohort 2 (arm C), representing high-risk patients treated with BRUKINSA monotherapy, were presented at the 62nd ASH Annual Meeting in December 2020.1 This cohort of patients with del(17p) achieved significant efficacy, with an 18-month PFS of 90.6%, as assessed by investigator. Full study results were published in Lancet Oncology.2 About BRUKINSA® (zanubrutinib) BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström’s macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. This information is intended for a global audience. Product indications vary by region. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. 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Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the efficacy and tolerability of zanubrutinib in combination with a BCL2 inhibitor for high-risk CLL patients; BRUKINSA’s ability to complement BCL2 therapies to achieve clinical response in high-risk CLL patients; the future progression of the SEQUOIA trial; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. To access BeiGene media resources, please visit our News & Media site. _____________________ 1 Tam CS, Giannopoulos K, Jurczak W, et al. SEQUOIA: Results of a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine + Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Blood. 2021;138(Supplement 1, p396) doi:10.1182/blood-2021-148457 2 Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncology. 2022;23(8):1031-1043. doi:10.1016/S1470-2045(22)00293-5. View source version on businesswire.com: Contacts Investor Contact: Liza Heapes +1 857-302-5663 ir@beigene.com Maryline Iva +41 61 685 2090 Source: BeiGene, Ltd. View this news release online at: