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Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study
Prnewswire· 2025-03-08 18:00
Core Insights - Eli Lilly and Incyte presented late-breaking results showing that 42.4% of adolescents treated with baricitinib 4 mg achieved 80% or more scalp hair coverage at Week 36, indicating significant hair regrowth potential for severe alopecia areata [1][2][3] - The Phase 3 BRAVE-AA-PEDS study demonstrated that baricitinib can provide clinically meaningful improvements in hair regrowth for adolescents, with results comparable to those seen in adults after a longer treatment duration [2][3] - Baricitinib is positioned as a leading treatment option for severe alopecia areata, with ongoing studies expected to provide further data and regulatory discussions in the near future [2][5] Study Results - In the BRAVE-AA-PEDS study, 257 patients were randomized to receive either baricitinib 4 mg, 2 mg, or placebo, with the primary endpoint being a SALT score of ≤20 at Week 36 [1][7] - At Week 36, 60.0% of patients on baricitinib 4 mg and 36.9% on 2 mg saw at least a 50% improvement in their disease, compared to only 5.7% on placebo [3] - Significant eyebrow and eyelash regrowth was also observed, with 50.0% and 42.9% of patients on baricitinib 4 mg achieving notable improvements, respectively [3] Safety Profile - The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections, with a higher frequency of serious adverse events in the placebo group [4] - The safety profile of baricitinib in adolescents aligns with previous findings in trials for juvenile idiopathic arthritis and atopic dermatitis, indicating a consistent safety record [4][5] Regulatory and Market Position - Baricitinib, marketed as Olumiant, is already approved for adult patients with severe alopecia areata and has received regulatory approval for other conditions, including rheumatoid arthritis and atopic dermatitis [5][6] - The company plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings and submit results for peer-reviewed publication, reinforcing its commitment to advancing treatment options for alopecia areata [5][6]
Reevaluating Incyte Corporation After Earnings (Technical Analysis)
Seeking Alpha· 2025-02-12 13:30
Group 1 - Incyte Corp. (NASDAQ: INCY) is a biotechnology company operating in the healthcare sector [1] - The company was previously discussed in July 2022, with a bullish outlook on its shares [1] - The focus is on building financial assets for retirement through various trading strategies, including long and short positions [1] Group 2 - The article does not contain any disclosures regarding stock or derivative positions in Incyte Corp. [2] - The author expresses personal opinions and is not receiving compensation for the article, aside from Seeking Alpha [2] - There is no business relationship with any company mentioned in the article [2]
Incyte: Q4 Earnings Outlines Multiple Drug Launches In 2025
Seeking Alpha· 2025-02-11 12:30
Group 1 - Brendan completed a Ph.D. at Stanford University in organic synthesis in 2009 [1] - He worked for Merck from 2009 to 2013 and has experience in biotech startups such as Theravance and Aspira [1] - Brendan is a co-founder of 1200 Pharma, which spun out of Caltech and received significant investment in the 8 figures [1] Group 2 - Brendan remains an avid investor focused on market trends, particularly in biotechnology stocks [1]
Incyte(INCY) - 2024 Q4 - Annual Report
2025-02-10 21:01
Financial Performance - Total revenues for the year ended December 31, 2024, were $4,241.2 million, a 14.8% increase from $3,695.6 million in 2023 [454]. - Product revenues, net, reached $3,618.9 million, up from $3,165.2 million in 2023, reflecting a 14.3% growth [454]. - The net income for 2024 was $32.6 million, a substantial decrease from $597.6 million in 2023 [454]. - Cash flows from operating activities for 2024 were $335,337 thousand, a decrease of 32.4% from $496,487 thousand in 2023 [461]. - Total stockholders' equity as of December 31, 2024, was $3,447,628 thousand, down from $5,189,837 thousand in 2023 [459]. - Net income for the year ended December 31, 2024, was $32,615 thousand, a decrease of 94.5% compared to $597,599 thousand in 2023 [461]. Research and Development - The company anticipates continued significant expenses in drug discovery and development, which may lead to future losses and challenges in achieving sustained profitability [310]. - Drug discovery and development expenditures are expected to increase as the company focuses on preclinical tests and clinical trials necessary for regulatory approval [311]. - Research and development expenses increased significantly to $2,606.8 million, compared to $1,627.6 million in 2023, marking a 60% rise [454]. - The company recognized a total of $679.4 million as research and development expenses related to the Escient acquisition [443]. - Research and development expenses include costs for clinical trials and pharmaceutical development, with amounts funded by collaborations recognized as incurred [507]. Acquisitions and Collaborations - The company acquired Escient Pharmaceuticals for $782.5 million, with $644.8 million allocated to the lead molecule EP262 as in-process research and development expenses [443]. - The company acquired exclusive global rights to tafasitamab for $25 million on February 5, 2024, enhancing its product portfolio [534]. - The Novartis collaboration agreement has generated $157.0 million in development milestones, $345.0 million in regulatory milestones, and $200.0 million in sales milestones since inception [546]. - The company entered into a collaboration agreement with China Medical Systems Holdings Limited for povorcitinib, recognizing an upfront payment of $25 million [576]. - The agreement with MacroGenics allows the company exclusive rights to develop and commercialize INCMGA0012, with total milestone payments to MacroGenics amounting to $215 million since inception [566]. Revenue Sources - The company derives a substantial portion of its revenues from royalties and milestone payments under collaboration agreements, with significant reliance on JAKAVI and OLUMIANT royalties [324]. - JAKAFI revenues increased to $2,792,107 in 2024, up 7.7% from $2,593,732 in 2023 [521]. - OPZELURA revenues grew significantly to $508,293 in 2024, a 50.4% increase from $337,864 in 2023 [521]. - Product royalty revenues from Novartis net sales of JAKAVI were $418.8 million in 2024, up from $367.6 million in 2023 [550]. - The Lilly agreement has resulted in $135.6 million in product royalty revenues related to OLUMIANT in 2024, consistent with previous years [555]. Financial Risks and Liabilities - The company may require additional capital in the future to fund its business plan and research and development efforts, depending on various factors including revenue generation and potential acquisitions [314]. - Changes in tax laws, such as the Tax Cuts and Jobs Act and the Inflation Reduction Act, could adversely affect the company's tax liabilities and financial condition [323]. - The company faces risks related to intellectual property, including potential litigation and the need to defend against infringement claims, which could disrupt drug development efforts [325]. - Current liabilities increased to $1,641.8 million in 2024, up from $1,240.4 million in 2023 [451]. - Total accrued and other current liabilities rose to $1.21 billion in 2024, up from $935.6 million in 2023, representing an increase of approximately 29% [591]. Inventory and Assets - Total inventory increased to $407.2 million in 2024 from $269.9 million in 2023, with raw materials at $27.6 million and API at $331.2 million [543]. - As of December 31, 2024, marketable securities totaled $470.3 million, primarily composed of U.S. government securities [428]. - Total assets decreased to $5,444.3 million in 2024 from $6,782.1 million in 2023 [451]. - The fair value of government debt securities increased to $470,263 as of December 31, 2024, from $442,667 in 2023 [522]. Operational and IT Risks - The company faces significant risks related to data security breaches, which could lead to loss of confidential information and reputational harm [339]. - The company is subject to potential fines under the General Data Protection Regulation, with fines up to €20 million or 4% of annual global revenue for noncompliance [342]. - The company is currently implementing a new enterprise resource planning system to support planned growth and manufacturing operations [338]. - The company is continuously evaluating and enhancing IT systems to address planned growth, which involves inherent costs and risks [338]. Stock and Equity - The company repurchased common stock amounting to $2,004,790 thousand in 2024, significantly impacting cash flows [461]. - Cash, cash equivalents, and restricted cash at the end of 2024 were $1,689,451 thousand, down from $3,215,221 thousand at the end of 2023 [461]. - The company assessed expected credit losses as de minimis, indicating strong creditworthiness of third-party sales relationships [533].
INCY's Q4 Earnings Miss Mark, Revenues Beat on Higher Product Sales
ZACKS· 2025-02-10 16:56
Core Viewpoint - Incyte Corporation reported mixed financial results for Q4 2024, with adjusted earnings per share falling short of estimates, while total revenues exceeded expectations, driven by strong performance from its key drugs Jakafi and Opzelura [1][2][3]. Financial Performance - Adjusted earnings for Q4 2024 were $1.43 per share, missing the Zacks Consensus Estimate of $1.53, compared to $1.06 per share in the same quarter last year [1]. - Total revenues for Q4 2024 reached $1.18 billion, reflecting a 16% year-over-year growth, surpassing the Zacks Consensus Estimate of $1.15 billion [2]. - For the full year 2024, Incyte generated revenues of $4.24 billion, indicating approximately 15% growth year over year, while adjusted earnings per share decreased to $1.08 from $3.52 in the previous year [12]. Drug Performance - Jakafi generated revenues of $773.1 million in Q4 2024, an 11% increase from the previous year, driven by a 14% rise in paid demand, exceeding the Zacks Consensus Estimate of $746 million [3]. - Opzelura cream sales reached $161.6 million, a 48% year-over-year increase, surpassing the Zacks Consensus Estimate of $150 million, attributed to growth in new patient starts and refills [4]. - Newly approved Zynyz generated $1.4 million in sales, while Iclusig and Pemazyre reported revenues of $27.4 million and $23.1 million, respectively, with Pemazyre beating its estimate [5]. Expense Overview - Adjusted research and development expenses totaled $420.3 million, up 3% year over year, primarily due to investments in late-stage development assets [10]. - Adjusted selling, general and administrative expenses were $299.7 million, reflecting an 11% increase from the prior year, mainly due to marketing activities [10]. Cash Position - As of December 31, 2024, Incyte's cash, cash equivalents, and marketable securities amounted to $2.2 billion, up from $1.8 billion as of September 30, 2024 [11]. 2025 Guidance - The company anticipates Jakafi revenues between $2.93 billion and $2.98 billion for 2025, with Opzelura net product revenues expected to be in the range of $630 million to $670 million [15]. - Adjusted research and development expenses are projected to be between $1.78 billion and $1.81 billion, while adjusted selling, general and administrative expenses are expected to range from $1.16 billion to $1.19 billion [15]. Recent Developments - Incyte and Syndax Pharmaceuticals received FDA approval for axatilimab-csfr, branded as Niktimvo, for treating GVHD, marking Incyte's second approved treatment for chronic GVHD [16]. - Management indicated that 2025 is expected to be a transformational year with four potential launches and several clinical milestones anticipated [17].
Incyte(INCY) - 2024 Q4 - Earnings Call Transcript
2025-02-10 16:52
Financial Data and Key Metrics Changes - Incyte reported total revenues of $4.2 billion for 2024, a 15% increase compared to 2023, continuing steady growth since 2020 [6][8] - Jakafi net sales reached $2.8 billion, growing 8% year-over-year, while Opzelura saw a significant growth of 50% to $508 million [7][16] - The company ended 2024 with $2.2 billion in cash and no debt, maintaining a strong financial position [8] Business Line Data and Key Metrics Changes - Jakafi's net product revenue in Q4 2024 was $773 million, an 11% increase year-over-year, with total patients increasing by 10% [12][34] - Opzelura's Q4 net product revenue was $162 million, up 48% year-over-year, driven by growth in atopic dermatitis and vitiligo [15][36] - The full-year net revenue for Opzelura was $508 million, reflecting a 50% increase compared to 2023 [16][36] Market Data and Key Metrics Changes - The U.S. market for Opzelura is expanding, with significant contributions from new patients and refills in both atopic dermatitis and vitiligo [7][15] - The company anticipates continued growth in both U.S. and international markets, particularly in Germany, France, Italy, and Spain for Opzelura [36][93] Company Strategy and Development Direction - Incyte plans to leverage its existing commercial infrastructure to support the launches of new products, including Niktimvo and ruxolitinib cream [11][31] - The company aims to deliver over 10 high-impact launches by 2030, with multiple pivotal data readouts expected in 2025 [22][31] - A focus on expanding its pipeline and increasing investment in late-stage development assets is evident, with plans for at least three Phase 3 studies in 2025 [18][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong financial position and robust pipeline, anticipating significant revenue contributions from upcoming product launches [9][11] - The company expects continued demand growth for Jakafi and Opzelura, despite potential pricing pressures from regulatory changes [40][41] - Management highlighted the importance of achieving statistical significance in upcoming clinical trials to ensure competitive positioning in the market [60][76] Other Important Information - The company completed a $2 billion share repurchase during 2024, reflecting confidence in its financial health [8] - A leadership change was announced, with Mohamed Issa taking over as Executive Vice President, Head of U.S. Oncology [20] Q&A Session Summary Question: Expectations for Opzelura's Phase 3 in prurigo nodularis - Management indicated that if the Phase 3 data is similar to Phase 2 results, it would be a significant addition for patients [50] Question: Guidance for Opzelura - The guidance reflects continued demand growth and potential contributions from pediatric indications and European markets [55][56] Question: Impact of IRA on patient out-of-pocket costs - Management noted that while there may be some savings, the benefits may take time to materialize in sales [64] Question: Phase 3 trials for povo in hidradenitis suppurativa - Management confirmed that they expect to disclose data through a press release and a call with the investment community [80] Question: Mutant CALR and JAK2V617F programs - Management expects to provide proof-of-concept data for both programs later this year, focusing on traditional endpoints and early evidence of reduction [86]
Incyte (INCY) Reports Q4 Earnings: What Key Metrics Have to Say
ZACKS· 2025-02-10 15:31
Core Insights - Incyte reported $1.18 billion in revenue for Q4 2024, a 16.3% year-over-year increase, with an EPS of $1.43 compared to $1.06 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $1.15 billion by 2.63%, while the EPS fell short of the consensus estimate of $1.53 by 6.54% [1] Revenue Breakdown - Product royalty revenues were $159.29 million, slightly below the average estimate of $161.69 million, reflecting a 6.5% year-over-year increase [4] - Net product revenues for Iclusig were $27.37 million, compared to the average estimate of $29.69 million, marking a 0.9% year-over-year change [4] - Net product revenues for Pemazyre reached $23.14 million, exceeding the average estimate of $19.08 million, with a year-over-year increase of 12.1% [4] - Net product revenues for Minjuvi/Monjuvi were $32.81 million, slightly below the estimate of $33.75 million, but showed a significant year-over-year increase of 264.8% [4] - Net product revenues for Opzelura were $161.60 million, surpassing the average estimate of $150.33 million, with a year-over-year increase of 47.9% [4] - Net product revenues for Jakafi were $773.11 million, exceeding the average estimate of $745.88 million, reflecting an 11.2% year-over-year increase [4] - Net product revenues for Zynyz were $1.37 million, above the average estimate of $0.96 million [4] - Total product revenues amounted to $1.02 billion, exceeding the average estimate of $999.96 million, with an 18.3% year-over-year increase [4] - Royalty revenues for Olumiant were $38.49 million, slightly below the estimate of $39.58 million, showing a 4.6% year-over-year decrease [4] - Royalty revenues for Tabrecta were $6.29 million, in line with the average estimate of $6.27 million, reflecting a 34.4% year-over-year increase [4] - Royalty revenues for Jakavi were $114.19 million, slightly below the estimate of $116.30 million, with a 9.9% year-over-year increase [4] - Royalty revenues for Pemazyre were $0.33 million, below the average estimate of $0.67 million [4] Stock Performance - Incyte's shares have returned +5.1% over the past month, outperforming the Zacks S&P 500 composite's +2.1% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]
Incyte (INCY) Q4 Earnings Miss Estimates
ZACKS· 2025-02-10 14:15
Group 1 - Incyte reported quarterly earnings of $1.43 per share, missing the Zacks Consensus Estimate of $1.53 per share, but showing an increase from $1.06 per share a year ago, resulting in an earnings surprise of -6.54% [1] - The company posted revenues of $1.18 billion for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 2.63%, compared to year-ago revenues of $1.01 billion [2] - Incyte shares have increased approximately 7.3% since the beginning of the year, outperforming the S&P 500's gain of 2.5% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is $1.24 on revenues of $1.02 billion, and for the current fiscal year, it is $6.17 on revenues of $4.64 billion [7] - The Medical - Biomedical and Genetics industry, to which Incyte belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]
Incyte(INCY) - 2024 Q4 - Earnings Call Presentation
2025-02-10 13:08
Financial Performance & Growth - Total revenues for 2024 grew by 15% year-over-year to $4.2 billion[10] - Jakafi net sales for FY 2024 were $2.792 billion, an increase of 8% year-over-year[23] - Opzelura net sales for FY 2024 were $508 million, representing a 50% increase year-over-year[31] - Q4 2024 Opzelura global net sales reached $162 million, a 48% increase year-over-year[31] Product Launches & Pipeline - Niktimvo U S launch is underway for 3L+ chronic Graft-Versus-Host Disease (GVHD)[16] - The company anticipates approximately $1 billion in incremental revenue by 2029 from near-term launches[20] - The company has more than 10 potential high impact launches by 2030[63] Financial Guidance - The company projects Jakafi net sales between $2.925 billion and $2.975 billion for FY 2025[24] - The company projects Opzelura net sales between $630 million and $670 million for FY 2025[31] R&D and Clinical Development - Povorcitinib is in Phase 3 development for Hidradenitis Suppurativa, Vitiligo, and Prurigo Nodularis, targeting patient populations of >300k, >1.5m, and >200k in the U S, respectively[50]
Incyte(INCY) - 2024 Q4 - Annual Results
2025-02-10 12:02
[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=section&id=Introduction%20and%202024%20Performance%20Overview) 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](index=4&type=chunk) - 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](index=4&type=chunk) [2025 Strategic Outlook and Key Milestones](index=1&type=section&id=2025%20Strategic%20Outlook%20and%20Key%20Milestones) 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](index=1&type=section&id=2025%20Defining%20Catalysts) 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](index=5&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) [Key Recent Company Updates](index=2&type=section&id=Key%20Recent%20Company%20Updates) Recent company updates highlight significant progress in product performance, regulatory approvals, and clinical trial advancements across Incyte's key therapeutic areas [Jakafi (ruxolitinib) Updates](index=2&type=section&id=Jakafi%20(ruxolitinib)%20Updates) 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](index=10&type=chunk) [Opzelura (ruxolitinib) Cream Updates](index=2&type=section&id=Opzelura%20(ruxolitinib)%20Cream%20Updates) 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](index=10&type=chunk) [Other Key Regulatory and Clinical Updates](index=2&type=section&id=Other%20Key%20Regulatory%20and%20Clinical%20Updates) 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](index=10&type=chunk) - In January **2025**, the FDA approved Niktimvo™ (axatilimab-csfr), which has since been launched in the U.S.[10](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) - A sNDA for Ruxolitinib cream (Opzelura®) for pediatric atopic dermatitis has been submitted to the FDA, with approval expected in **H2 2025**[10](index=10&type=chunk) [Additional Pipeline Updates](index=3&type=section&id=Additional%20Pipeline%20Updates) 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](index=3&type=section&id=Myeloproliferative%20Neoplasms%20(MPNs)%20and%20Graft-Versus-Host%20Disease%20(GVHD)%20Programs) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) [Other Hematology/Oncology Programs](index=3&type=section&id=Other%20Hematology/Oncology%20Programs) 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](index=15&type=chunk) - A Phase III study of tafasitamab in first-line DLBCL is ongoing, with Phase III data expected in **H1 2025**[15](index=15&type=chunk) - Phase I studies for KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing, with preliminary proof-of-concept data expected in **2025**[15](index=15&type=chunk) [Inflammation and Autoimmunity (IAI) Programs](index=4&type=section&id=Inflammation%20and%20Autoimmunity%20(IAI)%20Programs) 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](index=19&type=chunk) - A Phase III trial of ruxolitinib cream in mild-to-moderate hidradenitis suppurativa (HS) is planned to start in **H1 2025**[19](index=19&type=chunk) - Phase III studies of Povorcitinib in HS patients (STOP-HS1 and STOP-HS2) have **completed enrollment**, with data expected in **H1 2025**[19](index=19&type=chunk) - 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](index=19&type=chunk) [Other Programs](index=5&type=section&id=Other%20Programs) 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](index=5&type=section&id=2024%20Fourth%20Quarter%20and%20Year-end%20Financial%20Results) 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](index=5&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) 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](index=22&type=chunk) - The company provides **revenue data at constant exchange rates** to eliminate the impact of currency fluctuations on period-over-period comparisons[24](index=24&type=chunk) [Financial Highlights](index=6&type=section&id=Financial%20Highlights) 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](index=6&type=section&id=Revenue%20Details) 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](index=30&type=chunk) - Total royalty revenue increased by **6% in Q4 2024** and **11% for the full year**, primarily driven by growth in Jakavi royalty revenue[30](index=30&type=chunk) [Operating Expenses](index=7&type=section&id=Operating%20Expenses) 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](index=30&type=chunk) - 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](index=31&type=chunk) - Selling, general and administrative expenses increased primarily due to the **timing of consumer marketing activities and compensation expenses related to the Escient acquisition**[32](index=32&type=chunk) [Other Financial Information](index=8&type=section&id=Other%20Financial%20Information) 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](index=33&type=chunk) - Q4 2024 GAAP and non-GAAP operating income increased by **61% and 41%**, respectively, driven by total revenue growth and stable operating expenses[34](index=34&type=chunk) - 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](index=34&type=chunk) 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](index=9&type=section&id=2025%20Financial%20Guidance) Incyte provides its financial outlook for fiscal year 2025, including revenue projections for key products and guidance on operating expenses [Fiscal Year 2025 Guidance](index=9&type=section&id=Fiscal%20Year%202025%20Guidance) 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](index=36&type=chunk) - 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](index=36&type=chunk) [Company Information and Product Descriptions](index=9&type=section&id=Company%20Information%20and%20Product%20Descriptions) This section provides an overview of Incyte as a global biopharmaceutical company and detailed descriptions of its key commercialized products [About Incyte](index=9&type=section&id=About%20Incyte) 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](index=41&type=chunk) [About Jakafi (ruxolitinib)](index=9&type=section&id=About%20Jakafi%20(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](index=43&type=chunk) [About Opzelura (ruxolitinib) Cream](index=9&type=section&id=About%20Opzelura%20(ruxolitinib)%20Cream) 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](index=44&type=chunk)[45](index=45&type=chunk) - In Europe, Opzelura cream is approved for **nonsegmental vitiligo with facial involvement** in adults and adolescents 12 years and older[46](index=46&type=chunk) [About Monjuvi (tafasitamab-cxix)](index=10&type=section&id=About%20Monjuvi%20(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](index=48&type=chunk) - Incyte acquired **exclusive global development and commercialization rights to tafasitamab in February 2024**[48](index=48&type=chunk) - Monjuvi received **U.S. FDA accelerated approval in July 2020**, and Minjuvi received **European conditional marketing authorization in August 2021**[48](index=48&type=chunk) [About Pemazyre (pemigatinib)](index=10&type=section&id=About%20Pemazyre%20(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](index=49&type=chunk) - Pemazyre is also approved for **cholangiocarcinoma in Europe and Japan**[50](index=50&type=chunk) [About Iclusig (ponatinib) Tablets](index=10&type=section&id=About%20Iclusig%20(ponatinib)%20tablets) 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](index=53&type=chunk) - 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](index=54&type=chunk) [About Zynyz (retifanlimab-dlwr)](index=11&type=section&id=About%20Zynyz%20(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](index=56&type=chunk) - This indication was granted under **accelerated approval**, with continued approval contingent on verification of clinical benefit in confirmatory trials[56](index=56&type=chunk) [Forward-Looking Statements and Contacts](index=11&type=section&id=Forward-Looking%20Statements%20and%20Contacts) This section provides important disclaimers regarding forward-looking statements and contact information for media and investor inquiries [Forward-Looking Statements](index=11&type=section&id=Forward-Looking%20Statements) 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](index=58&type=chunk) - 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](index=59&type=chunk) [Contacts](index=12&type=section&id=Contacts) Incyte provides contact email addresses for media and investors - Media contact email: **media@incyte.com**[61](index=61&type=chunk) - Investor contact email: **ir@incyte.com**[61](index=61&type=chunk) [Condensed Consolidated Financial Statements](index=13&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=14&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=15&type=section&id=Reconciliation%20of%20GAAP%20Net%20Income%20to%20Selected%20Non-GAAP%20Adjusted%20Information) 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](index=66&type=chunk)[67](index=67&type=chunk)