Incyte(INCY) - 2024 Q4 - Annual Results

Executive Summary This section provides an overview of Incyte's strong financial performance in 2024 and its strategic outlook for 2025, highlighting key product growth and future milestones Introduction and 2024 Performance Overview Incyte achieved strong financial results in Q4 and full-year 2024, with total revenue growing 15% year-over-year, primarily driven by significant growth in Jakafi and Opzelura - Total revenue grew 15% in 2024, primarily driven by strong growth in Jakafi and Opzelura[4] - Incyte anticipates 2025 to be a year of continued strong revenue growth and diversification, with multiple key milestones targeting over 10 impactful product launches by 2030[4] 2025 Strategic Outlook and Key Milestones Incyte outlines its strategic vision for 2025, focusing on significant product launches, clinical trial initiations, and key data readouts across its diverse pipeline 2025 Defining Catalysts Incyte expects to achieve at least 18 key milestones in 2025, including four new product launches, at least three Phase III study initiations, four pivotal study data readouts, and seven proof-of-concept study data readouts, signaling significant portfolio expansion and clinical advancement 2024 Financial Results and 2025 Guidance (Mentioned in Key Catalysts Section) | Metric | Q4 2024 | Full-Year 2024 | Full-Year 2025 Guidance | | :--- | :--- | :--- | :--- | | Total Revenue | $1.2 billion (+16% YoY) | $4.2 billion (+15% YoY) | - | | Jakafi Net Revenue | $773 million (+11% YoY) | $2.8 billion (+8% YoY) | $2.925 billion - $2.975 billion | | Opzelura Net Revenue | $162 million (+48% YoY) | $508 million (+50% YoY) | $630 million - $670 million | - 2025 is expected to be a year of defining catalysts, including four product launches, four pivotal study data readouts, at least three Phase III study initiations, and seven proof-of-concept study data readouts[5] - Four new product launches planned for 2025 include Niktimvo™ (3L+ chronic GVHD), ruxolitinib cream (pediatric atopic dermatitis), tafasitamab (relapsed/refractory follicular lymphoma), and retifanlimab (squamous cell anal carcinoma)[6] - At least three Phase III study initiations planned for 2025 include a BET inhibitor (2L myelofibrosis), ruxolitinib cream (mild-to-moderate hidradenitis suppurativa), and a CDK2 inhibitor (ovarian cancer)[6] - Four pivotal study data readouts expected in 2025 include Povorcitinib (moderate-to-severe hidradenitis suppurativa), ruxolitinib cream (prurigo nodularis), tafasitamab (1L diffuse large B-cell lymphoma), and ruxolitinib XR (myelofibrosis, polycythemia vera, and GVHD)[6] - Seven proof-of-concept study data readouts expected in 2025 include Povorcitinib (chronic spontaneous urticaria and asthma), mutCALR (myelofibrosis and essential thrombocythemia), JAK2V617F mutation-specific inhibitor (myelofibrosis), and KRASG12D and TGFβR2xPD-1 (solid tumors)[6] Key Recent Company Updates Recent company updates highlight significant progress in product performance, regulatory approvals, and clinical trial advancements across Incyte's key therapeutic areas Jakafi (ruxolitinib) Updates Jakafi's net product revenue grew 11% in Q4 2024 and 8% for the full year, primarily driven by increased paid demand, with channel inventory remaining within normal ranges Jakafi Net Product Revenue | Period | Q4 2024 | Full-Year 2024 | | :--- | :--- | :--- | | Net Product Revenue | $773 million | $2.792 billion | | YoY Growth | 11% | 8% | | Paid Demand Growth | 14% | 9% | - Jakafi net product revenue growth was primarily driven by paid demand, increasing 14% in Q4 and 9% for the full year, covering all indications[10] Opzelura (ruxolitinib) Cream Updates Opzelura's net product revenue significantly increased by 48% in Q4 2024 and 50% for the full year, driven by new patient starts and refills in the U.S. and growing contributions from European markets Opzelura Net Product Revenue | Period | Q4 2024 | Full-Year 2024 | | :--- | :--- | :--- | | Net Product Revenue | $162 million | $508 million | | YoY Growth | 48% | 50% | | Revenue Outside U.S. | $24 million (Q4) / $61 million (Full-Year) | - Opzelura revenue growth was primarily driven by patient demand and refills for atopic dermatitis and vitiligo, as well as increased contributions from European markets[10] Other Key Regulatory and Clinical Updates Incyte achieved several important regulatory and clinical milestones recently, including FDA approval and launch of Niktimvo™, tafasitamab reaching its primary endpoint in a Phase III trial for relapsed/refractory follicular lymphoma, and sBLAs submitted for retifanlimab and ruxolitinib cream in pediatric atopic dermatitis, with approvals expected in H2 2025 - A bioequivalence study for ruxolitinib extended-release (XR) has been completed, with data expected to be submitted to the FDA by late 2025[10] - In January 2025, the FDA approved Niktimvo™ (axatilimab-csfr), which has since been launched in the U.S.[10] - In December 2024, tafasitamab (Monjuvi®) met its primary endpoint in the Phase III inMIND trial for relapsed/refractory follicular lymphoma, with FDA approval expected in H2 2025[10] - The BET inhibitor (INCB057643) showed improvements in anemia, spleen size, and symptom burden in patients with relapsed/refractory myelofibrosis, with a Phase III monotherapy study planned for 2025[10] - A sBLA for Retifanlimab (Zynyz®) for advanced/metastatic squamous cell anal carcinoma has been submitted to the FDA, with approval expected in H2 2025[10] - A sNDA for Ruxolitinib cream (Opzelura®) for pediatric atopic dermatitis has been submitted to the FDA, with approval expected in H2 2025[10] Additional Pipeline Updates Incyte provides updates on its diverse pipeline, including advancements in myeloproliferative neoplasms, graft-versus-host disease, other hematology/oncology programs, and inflammation/autoimmunity Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) Programs Incyte's MPN and GVHD pipeline includes Ruxolitinib XR (once-daily) for myelofibrosis, polycythemia vera, and GVHD, and a combination therapy of Ruxolitinib with INCB57643 for myelofibrosis. Additionally, axatilimab is undergoing Phase II and III studies in chronic GVHD, with early-stage mutCALR and JAK2V617Fi programs also enrolling patients and preliminary proof-of-concept data expected in 2025 MPN and GVHD Program Overview | Program | Indication and Phase | | :--- | :--- | | Ruxolitinib XR (QD) | Myelofibrosis, Polycythemia Vera, and GVHD | | Ruxolitinib + INCB57643 | Myelofibrosis: Phase II | | Ruxolitinib + axatilimab | Chronic GVHD: Phase II | | Steroids + axatilimab | Chronic GVHD: Phase III | | INCA33989 (mutCALR) | Myelofibrosis, Essential Thrombocythemia: Phase I | | INCB160058 (JAK2V617Fi) | Myelofibrosis: Phase I | - Phase I studies for mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET), and JAK2V617Fi in MF are ongoing, with preliminary proof-of-concept data expected in 2025[14] - A Phase II trial of axatilimab (Niktimvo™) combined with ruxolitinib (Jakafi®) for newly diagnosed chronic GVHD was initiated in Q4 2024 and is currently enrolling patients[14] - A Phase III randomized, double-blind, placebo-controlled, multi-center trial of axatilimab combined with corticosteroids as initial treatment for chronic GVHD has been initiated and is enrolling patients[14] Other Hematology/Oncology Programs Incyte's hematology/oncology pipeline includes tafasitamab in various DLBCL and FL indications, retifanlimab for squamous cell anal carcinoma and non-small cell lung cancer, and early-stage solid tumor programs like CDK2 inhibitor, KRASG12D, and TGFßR2×PD-1. Several pivotal studies and proof-of-concept data are expected in 2025 Other Hematology/Oncology Program Overview | Program | Indication and Phase | | :--- | :--- | | Tafasitamab (Monjuvi®/Minjuvi®) | Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL): Phase III (B-MIND); First-line DLBCL: Phase III (frontMIND); Relapsed or Refractory Follicular Lymphoma (FL): Phase III (inMIND) | | Retifanlimab (Zynyz®) | Squamous Cell Anal Carcinoma (SCAC): Phase III (POD1UM-303); Non-Small Cell Lung Cancer (NSCLC): Phase III (POD1UM-304); MSI-high Endometrial Cancer: Phase II (POD1UM-101, POD1UM-204) | | INCB123667 (CDK2i) | Solid Tumors with CCNE1 Amplification/Cyclin E Overexpression: Phase I | | INCB161734 (KRASG12D) | Advanced or Metastatic Solid Tumors with KRASG12D Mutation: Phase I | | INCA33890 (TGFßR2×PD-1) | Advanced or Metastatic Solid Tumors: Phase I | - Incyte plans to initiate a Phase III study of its potential first-in-class CDK2 inhibitor (INCB123667) in ovarian cancer in 2025[15] - A Phase III study of tafasitamab in first-line DLBCL is ongoing, with Phase III data expected in H1 2025[15] - Phase I studies for KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing, with preliminary proof-of-concept data expected in 2025[15] Inflammation and Autoimmunity (IAI) Programs In the inflammation and autoimmunity area, ruxolitinib cream's Phase III trials for prurigo nodularis have completed enrollment, with data expected in H1 2025, and a Phase III trial for mild-to-moderate hidradenitis suppurativa is planned for H1 2025. Povorcitinib's Phase III studies in hidradenitis suppurativa have completed enrollment, with data expected in H1 2025, and its Phase II trials in chronic spontaneous urticaria and asthma are ongoing, with data expected in H1 and H2 2025, respectively IAI and Dermatology Program Overview | Program | Indication and Phase | | :--- | :--- | | Ruxolitinib cream (Opzelura®) | Atopic Dermatitis: Phase III Pediatric Study (TRuE-AD3); Hidradenitis Suppurativa: Phase II; Phase III expected to start in 2025; Prurigo Nodularis: Phase III (TRuE-PN1, TRuE-PN2) | | Povorcitinib (JAK1) | Hidradenitis Suppurativa: Phase III (STOP-HS1, STOP-HS2); Vitiligo: Phase III (STOP-V1, STOP-V2); Prurigo Nodularis: Phase III (STOP-PN1, STOP-PN2); Chronic Spontaneous Urticaria: Phase II; Asthma: Phase II | | INCA034460 (anti-CD122) | Vitiligo: Phase I | - Two Phase III trials of ruxolitinib cream in prurigo nodularis (PN) (TRuE-PN1 and TRuE-PN2) have completed enrollment, with data expected in H1 2025[19] - A Phase III trial of ruxolitinib cream in mild-to-moderate hidradenitis suppurativa (HS) is planned to start in H1 2025[19] - Phase III studies of Povorcitinib in HS patients (STOP-HS1 and STOP-HS2) have completed enrollment, with data expected in H1 2025[19] - Phase II data for Povorcitinib in chronic spontaneous urticaria (CSU) is expected in H1 2025, and Phase II data in asthma is expected in H2 2025[19] Other Programs Incyte's other pipeline projects include Zilurgisertib, currently in a pivotal Phase II study for fibrodysplasia ossificans progressiva (FOP) Other Program Overview | Program | Indication and Phase | | :--- | :--- | | Zilurgisertib (ALK2) | Fibrodysplasia Ossificans Progressiva: Pivotal Phase II | 2024 Fourth Quarter and Year-end Financial Results Incyte reports its financial performance for Q4 and full-year 2024, highlighting revenue growth, operating expenses, and key balance sheet items, with explanations for non-GAAP adjustments Explanation of Non-GAAP Financial Measures Incyte provides non-GAAP financial information to supplement GAAP disclosures, which management believes helps investors better understand the company's core operating performance - Non-GAAP information supplements GAAP disclosures, helping investors understand core operating performance and used for internal budgeting, operational goals, and financial planning[22] - The company provides revenue data at constant exchange rates to eliminate the impact of currency fluctuations on period-over-period comparisons[24] Financial Highlights Incyte achieved significant revenue growth in Q4 and full-year 2024, with total GAAP revenue increasing by 16% and 15% respectively. However, full-year GAAP operating income and net income significantly decreased, primarily due to Escient acquisition-related expenses and milestone payments 2024 Fourth Quarter and Full-Year Financial Highlights (Unaudited, in thousand USD, except per share amounts) | Metric | Q4 2024 | Q4 2023 | Full-Year 2024 | Full-Year 2023 | | :--- | :--- | :--- | :--- | :--- | | Total GAAP Revenue | $1,178,698 | $1,013,341 | $4,241,217 | $3,695,649 | | Total GAAP Operating Income | $301,513 | $187,270 | $61,366 | $620,525 | | Total Non-GAAP Operating Income | $376,265 | $267,702 | $413,883 | $892,783 | | GAAP Net Income | $201,212 | $201,079 | $32,615 | $597,599 | | Non-GAAP Net Income | $281,353 | $239,124 | $227,591 | $795,449 | | GAAP Diluted EPS | $1.02 | $0.89 | $0.15 | $2.65 | | Non-GAAP Diluted EPS | $1.43 | $1.06 | $1.08 | $3.52 | Revenue Details Total net product and royalty revenues grew 17% in Q4 2024 and 14% for the full year. Net product revenues for Jakafi and Opzelura continued to grow, with Opzelura showing particularly strong increases. Minjuvi/Monjuvi net product revenue significantly increased due to obtaining global exclusive rights. Jakavi royalty revenue also contributed to overall growth 2024 Fourth Quarter and Full-Year Revenue Details (Unaudited, in thousand USD) | Product/Revenue Type | Q4 2024 | Q4 2023 | YOY Change (Reported) | Full-Year 2024 | Full-Year 2023 | YOY Change (Reported) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue: | | | | | | | | Jakafi | $773,114 | $695,127 | 11 % | $2,792,107 | $2,593,732 | 8 % | | Opzelura | $161,602 | $109,243 | 48 % | $508,293 | $337,864 | 50 % | | Iclusig | $27,369 | $27,130 | 1 % | $114,319 | $111,623 | 2 % | | Pemazyre | $23,142 | $20,653 | 12 % | $81,748 | $83,642 | (2 %) | | Minjuvi/Monjuvi | $32,807 | $8,994 | 265 % | $119,236 | $37,057 | 222 % | | Zynyz | $1,373 | $582 | 136 % | $3,185 | $1,250 | 155 % | | Total Net Product Revenue | $1,019,407 | $861,729 | 18 % | $3,618,888 | $3,165,168 | 14 % | | Royalty Revenue: | | | | | | | | Jakavi | $114,187 | $103,892 | 10 % | $418,840 | $367,583 | 14 % | | Olumiant | $38,485 | $40,359 | (5 %) | $135,572 | $136,138 | — % | | Tabrecta | $6,286 | $4,678 | 34 % | $22,746 | $17,793 | 28 % | | Pemazyre | $333 | $683 | NM | $2,171 | $1,967 | NM | | Total Royalty Revenue | $159,291 | $149,612 | 6 % | $579,329 | $523,481 | 11 % | | Milestone and Contract Revenue | — | $2,000 | — % | $43,000 | $7,000 | 514 % | | Total GAAP Revenue | $1,178,698 | $1,013,341 | 16 % | $4,241,217 | $3,695,649 | 15 % | - Minjuvi/Monjuvi net product revenue increased by 265% in Q4 2024 and 222% for the full year, primarily due to the company recognizing all U.S. sales after acquiring exclusive global rights to tafasitamab in February 2024[30] - Total royalty revenue increased by 6% in Q4 2024 and 11% for the full year, primarily driven by growth in Jakavi royalty revenue[30] Operating Expenses Product cost, R&D expenses, and selling, general, and administrative expenses all increased in Q4 and full-year 2024. The rise in product cost was mainly due to increased net product revenue, higher royalty expenses, and manufacturing costs. R&D expenses significantly grew by 60% for the full year, impacted by upfront consideration, related compensation expenses, and milestone payments from the Escient acquisition. Selling, general, and administrative expenses increased primarily due to consumer marketing activities and Escient acquisition-related compensation expenses 2024 Fourth Quarter and Full-Year Operating Expenses Overview (Unaudited, in thousand USD) | Metric | Q4 2024 | Q4 2023 | YOY Change | Full-Year 2024 | Full-Year 2023 | YOY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | GAAP Cost of Products Sold | $88,485 | $69,751 | 27 % | $312,068 | $254,990 | 22 % | | Non-GAAP Cost of Products Sold | $82,427 | $63,575 | 30 % | $288,266 | $230,308 | 25 % | | GAAP R&D Expenses | $466,034 | $444,494 | 5 % | $2,606,848 | $1,627,594 | 60 % | | Non-GAAP R&D Expenses | $420,297 | $408,488 | 3 % | $2,423,167 | $1,500,897 | 61 % | | GAAP Selling, General and Administrative Expenses | $326,710 | $293,865 | 11 % | $1,242,157 | $1,161,293 | 7 % | | Non-GAAP Selling, General and Administrative Expenses | $299,709 | $270,673 | 11 % | $1,116,926 | $1,069,616 | 4 % | - The increase in product cost was primarily due to higher net product revenue, increased royalty expenses, and higher manufacturing costs[30] - Full-year R&D expenses significantly increased by 60% (GAAP) and 61% (non-GAAP), primarily impacted by upfront consideration, related compensation expenses, and milestone payments from the Escient acquisition[31] - Selling, general and administrative expenses increased primarily due to the timing of consumer marketing activities and compensation expenses related to the Escient acquisition[32] Other Financial Information Operating income significantly increased in Q4 2024, but full-year GAAP and non-GAAP operating income both decreased, primarily due to Escient acquisition-related in-process research and development intangible assets, compensation expenses, and MacroGenics milestone payments. As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $2.2 billion, a decrease from $3.7 billion at the end of 2023, mainly due to a $2 billion share repurchase in June 2024 and a $783 million cash consideration paid to Escient shareholders - Changes in the fair value of acquisition-related contingent consideration were primarily impacted by exchange rate fluctuations affecting future Iclusig revenue forecasts[33] - Q4 2024 GAAP and non-GAAP operating income increased by 61% and 41%, respectively, driven by total revenue growth and stable operating expenses[34] - Full-year 2024 GAAP and non-GAAP operating income decreased by 90% and 54%, respectively, primarily due to $679.4 million in-process research and development intangible assets related to the Escient acquisition, $38 million in compensation expenses, and a $100 million milestone payment to MacroGenics[34] Cash, Cash Equivalents, and Marketable Securities | As of Date | Amount (billion USD) | | :--- | :--- | | December 31, 2024 | $2.2 | | December 31, 2023 | $3.7 | | Reason for Change | $2 billion share repurchase and $783 million Escient acquisition cash consideration in 2024, partially offset by proceeds from equity investment sales and operating cash flow | 2025 Financial Guidance Incyte provides its financial outlook for fiscal year 2025, including revenue projections for key products and guidance on operating expenses Fiscal Year 2025 Guidance Incyte provides its fiscal year 2025 financial guidance, projecting Jakafi net product revenue between $2.925 billion and $2.975 billion, Opzelura net product revenue between $630 million and $670 million, and other oncology net product revenue between $415 million and $455 million. The guidance includes anticipated revenue from Opzelura for pediatric atopic dermatitis, Monjuvi for follicular lymphoma, and Zynyz for squamous cell anal carcinoma, all expected to be approved in H2 2025 Fiscal Year 2025 Financial Guidance | Metric | Guidance Range | | :--- | :--- | | Jakafi Net Product Revenue | $2,925 - $2,975 million | | Opzelura Net Product Revenue | $630 - $670 million | | Other Oncology Net Product Revenue | $415 - $455 million | | GAAP Cost of Products Sold | 8.5% - 9.0% of net product revenue | | Non-GAAP Cost of Products Sold | 7.5% - 8.0% of net product revenue | | GAAP R&D Expenses | $1,930 - $1,960 million | | Non-GAAP R&D Expenses | $1,780 - $1,805 million | | GAAP Selling, General and Administrative Expenses | $1,280 - $1,310 million | | Non-GAAP Selling, General and Administrative Expenses | $1,160 - $1,185 million | - Opzelura's guidance includes net product revenue for pediatric atopic dermatitis, expected to be approved in H2 2025[36] - Other oncology net product revenue guidance includes net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma, both expected to be approved in H2 2025[36] Company Information and Product Descriptions This section provides an overview of Incyte as a global biopharmaceutical company and detailed descriptions of its key commercialized products About Incyte Incyte is a global biopharmaceutical company dedicated to providing solutions for unmet medical needs through the discovery, development, and commercialization of proprietary therapeutics - Incyte is a global biopharmaceutical company focused on proprietary therapies in oncology and inflammation & autoimmunity[41] About Jakafi (ruxolitinib) Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor, approved by the U.S. FDA for the treatment of adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea, adults with intermediate or high-risk myelofibrosis (including primary MF, post-PV MF, and post-ET MF), and adult and pediatric patients 12 years and older with steroid-refractory acute GVHD and chronic GVHD - Jakafi is a JAK1/JAK2 inhibitor, approved for treating polycythemia vera, myelofibrosis, and steroid-refractory acute and chronic GVHD[43] About Opzelura (ruxolitinib) Cream Opzelura (ruxolitinib) cream is a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the treatment of nonsegmental vitiligo in patients 12 years and older (the first and only FDA-approved therapy for repigmentation in the U.S.), and for the topical short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis - Opzelura cream is a topical formulation of the JAK1/JAK2 inhibitor ruxolitinib, approved for treating nonsegmental vitiligo (the first U.S. repigmentation therapy) and mild-to-moderate atopic dermatitis in patients 12 years and older[44][45] - In Europe, Opzelura cream is approved for nonsegmental vitiligo with facial involvement in adults and adolescents 12 years and older[46] About Monjuvi (tafasitamab-cxix) Monjuvi (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Incyte acquired exclusive global development and commercialization rights to tafasitamab in February 2024. Monjuvi received accelerated approval from the U.S. FDA in July 2020 and is currently commercialized by Incyte in the U.S. In Europe, Minjuvi received conditional marketing authorization in August 2021 - Monjuvi is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, mediating B-cell lysis through apoptosis and immune effector mechanisms[48] - Incyte acquired exclusive global development and commercialization rights to tafasitamab in February 2024[48] - Monjuvi received U.S. FDA accelerated approval in July 2020, and Minjuvi received European conditional marketing authorization in August 2021[48] About Pemazyre (pemigatinib) Pemazyre (pemigatinib) is a kinase inhibitor, approved in the U.S. for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (with FGFR2 fusion or other rearrangements), and relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Pemazyre is also approved for cholangiocarcinoma in Europe and Japan - Pemazyre is a kinase inhibitor, approved in the U.S. for treating cholangiocarcinoma with FGFR2 fusion or other rearrangements, and myeloid/lymphoid neoplasms with FGFR1 rearrangement[49] - Pemazyre is also approved for cholangiocarcinoma in Europe and Japan[50] About Iclusig (ponatinib) Tablets Iclusig (ponatinib) is a drug targeting BCR-ABL and its resistant mutations, including the T315I mutation. In the EU, Iclusig is approved for the treatment of adult patients with chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib, or those with the T315I mutation, and adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to dasatinib, or those with the T315I mutation - Iclusig targets BCR-ABL and its resistant mutations, including the T315I mutation[53] - In the EU, Iclusig is approved for adult CML patients resistant/intolerant to dasatinib or nilotinib, or with the T315I mutation, and adult Ph+ ALL patients resistant/intolerant to dasatinib, or with the T315I mutation[54] About Zynyz (retifanlimab-dlwr) Zynyz (retifanlimab) is an intravenous PD-1 inhibitor, approved in the U.S. for the treatment of adult metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) - Zynyz is an intravenous PD-1 inhibitor, approved in the U.S. for treating adult metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)[56] - This indication was granted under accelerated approval, with continued approval contingent on verification of clinical benefit in confirmatory trials[56] Forward-Looking Statements and Contacts This section provides important disclaimers regarding forward-looking statements and contact information for media and investor inquiries Forward-Looking Statements This press release contains forward-looking statements regarding Incyte's continued performance and growth potential, 2025 financial guidance, product launches, label expansion opportunities, R&D pipeline progress, clinical trial results, regulatory approvals, and 2025 news flow - Forward-looking statements cover Incyte's performance, 2025 financial guidance, product launches, R&D pipeline progress, clinical trial results, and regulatory approvals[58] - These statements are subject to various risks and uncertainties, including R&D failures, regulatory decisions, changes in collaborations, market competition, and exchange rate fluctuations[59] Contacts Incyte provides contact email addresses for media and investors - Media contact email: media@incyte.com[61] - Investor contact email: ir@incyte.com[61] Condensed Consolidated Financial Statements This section presents Incyte's condensed consolidated financial statements, including statements of operations, balance sheets, and reconciliation of GAAP to non-GAAP financial information Condensed Consolidated Statements of Operations In Q4 2024, Incyte reported total revenue of $1.179 billion and net income of $201 million. For the full year, total revenue was $4.241 billion, and net income was $32.615 million. Full-year net income significantly decreased compared to 2023, primarily due to R&D expenses and acquisition-related costs Condensed Consolidated Statements of Operations (Unaudited, in thousand USD, except per share amounts) | Metric | Q4 2024 | Q4 2023 | Full-Year 2024 | Full-Year 2023 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $1,019,407 | $861,729 | $3,618,888 | $3,165,168 | | Product royalty revenue | $159,291 | $149,612 | $579,329 | $523,481 | | Milestone and contract revenue | — | $2,000 | $43,000 | $7,000 | | Total revenue | $1,178,698 | $1,013,341 | $4,241,217 | $3,695,649 | | Cost of products sold (including amortization of acquired intangible assets) | $88,485 | $69,751 | $312,068 | $254,990 | | Research and development expenses | $466,034 | $444,494 | $2,606,848 | $1,627,594 | | Selling, general and administrative expenses | $326,710 | $293,865 | $1,242,157 | $1,161,293 | | Operating income | $301,513 | $187,270 | $61,366 | $620,525 | | Net income | $201,212 | $201,079 | $32,615 | $597,599 | | Net income per diluted share | $1.02 | $0.89 | $0.15 | $2.65 | Condensed Consolidated Balance Sheets As of December 31, 2024, Incyte's total assets were $5.444 billion, a decrease from $6.782 billion at the end of 2023. Cash, cash equivalents, and marketable securities decreased from $3.656 billion to $2.158 billion, primarily due to share repurchases and acquisition payments. Accounts payable, accrued expenses, and other liabilities increased, while stockholders' equity decreased from $5.190 billion to $3.448 billion Condensed Consolidated Balance Sheets (Unaudited, in thousand USD) | Metric | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable securities | $2,158,092 | $3,656,043 | | Accounts receivable | $853,154 | $743,557 | | Inventories | $407,199 | $269,937 | | Total assets | $5,444,322 | $6,782,107 | | Liabilities and Stockholders' Equity | | | | Accounts payable, accrued expenses and other liabilities | $1,765,733 | $1,347,669 | | Acquisition-related contingent consideration | $193,000 | $212,000 | | Stockholders' equity | $3,447,628 | $5,189,837 | | Total liabilities and stockholders' equity | $5,444,322 | $6,782,107 | Reconciliation of GAAP Net Income to Selected Non-GAAP Adjusted Information Incyte provides a reconciliation of GAAP net income to non-GAAP adjusted information to exclude the impact of non-recurring or non-cash items such as stock-based compensation, non-cash interest, equity investment gains/losses, amortization of acquired product rights, fair value changes of contingent consideration, asset impairments, MorphoSys transition costs, and Escient acquisition-related compensation expenses, thereby better reflecting core business profitability Reconciliation of GAAP Net Income to Selected Non-GAAP Adjusted Information (Unaudited, in thousand USD, except per share amounts) | Metric | Q4 2024 | Q4 2023 | Full-Year 2024 | Full-Year 2023 | | :--- | :--- | :--- | :--- | :--- | | GAAP Net Income | $201,212 | $201,079 | $32,615 | $597,599 | | Adjustments: | | | | | | Non-cash stock-based compensation expense (R&D) | $44,110 | $36,006 | $161,251 | $126,697 | | Non-cash stock-based compensation expense (SG&A) | $26,935 | $23,192 | $102,542 | $86,046 | | Realized and unrealized gains (losses) on equity investments | $10,181 | ($34,054) | ($116,025) | ($43,893) | | Amortization of acquired product rights | $5,384 | $5,384 | $21,536 | $21,536 | | Change in fair value of acquisition-related contingent consideration | ($4,044) | $15,058 | $19,803 | $29,202 | | Escient acquisition-related compensation expense | $1,693 | — | $38,035 | — | | Tax impact | ($4,874) | ($8,441) | ($41,931) | ($30,978) | | Non-GAAP Net Income | $281,353 | $239,124 | $227,591 | $795,449 | | Non-GAAP Diluted Net Income Per Share | $1.43 | $1.06 | $1.08 | $3.52 | - Non-GAAP adjustments primarily include non-cash stock-based compensation, equity investment gains/losses, amortization of acquired product rights, fair value changes of contingent consideration, MorphoSys transition costs, and Escient acquisition-related compensation expenses[66][67]