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EC Approves Label Expansion of INCY's Lymphoma Drug Minjuvi
ZACKS· 2025-12-18 15:31
Core Insights - Incyte (INCY) has received approval from the European Commission (EC) for a label expansion of Minjuvi (tafasitamab) to treat adult patients with relapsed or refractory follicular lymphoma (FL) in combination with Revlimid (lenalidomide) and rituximab [1][9] Approval Details - This marks the second indication for Minjuvi in the EU, as it was previously approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [2] - The latest approval is based on the inMIND study, which demonstrated significantly improved progression-free survival for patients with relapsed or refractory FL when treated with Minjuvi, Revlimid, and rituximab [3][9] - Minjuvi was generally well-tolerated, with a safety profile comparable to the combination of Revlimid and rituximab [4] Market Context - Follicular lymphoma is the most common indolent form of B-cell non-Hodgkin lymphoma, accounting for approximately 30% of NHL cases globally, with a significant unmet need for new treatment options [5] - The approval of Minjuvi introduces the first dual-targeted CD19 and CD20 immunotherapy for eligible FL patients in Europe, showing a meaningful reduction in disease progression risk [6] Company Strategy - Incyte is diversifying its portfolio beyond its lead drug Jakafi, which is a JAK1/JAK2 inhibitor, by gaining new approvals for Minjuvi and other drugs [7][10] - The company has seen strong uptake of recently approved drugs, including Pemazyre, Monjuvi, and Tabrecta, which will further enhance its revenue base [10] Financial Performance - Incyte has performed well in 2025, with shares surging 45.6% over the year, significantly outperforming the industry growth of 16.9% [11] - The company has also entered a global collaboration with Qiagen to develop a diagnostic panel for myeloproliferative neoplasms, which is expected to support its pipeline of investigational treatments [12][13]
Incyte (INCY) Up 17.2% Since Last Earnings Report: Can It Continue?
ZACKS· 2025-11-27 17:31
Core Viewpoint - Incyte Corporation has shown strong performance in its recent earnings report, with significant growth in revenues and earnings per share, driven by the success of its key products, particularly Jakafi and Opzelura, leading to a positive outlook for the stock [2][3][4]. Financial Performance - Incyte reported Q3 2025 adjusted earnings of $2.26 per share, exceeding the Zacks Consensus Estimate of $1.66, and up from $1.07 per share in the same quarter last year [2]. - Total revenues for Q3 2025 reached $1.37 billion, reflecting a 20% year-over-year increase, surpassing the Zacks Consensus Estimate of $1.26 billion [3]. Product Sales Breakdown - Jakafi sales amounted to $791.1 million, a 7% increase year-over-year, driven by a 10% rise in paid demand, beating the Zacks Consensus Estimate of $770 million [4]. - Opzelura generated $188 million in sales, up 35% year-over-year, exceeding the Zacks Consensus Estimate of $179.1 million, attributed to increased patient demand [5]. - Zynyz, a newly approved drug, recorded sales of $22.7 million, significantly higher than the Zacks Consensus Estimate of $9.5 million [6]. - Iclusig sales were $37.6 million, up 26% year-over-year, surpassing the Zacks Consensus Estimate of $30.6 million [7]. - Pemazyre generated $22.7 million in sales, reflecting a 10% year-over-year increase, beating the Zacks Consensus Estimate of $22 million [7]. - Minjuvi's revenues totaled $42 million, a 34% increase year-over-year, exceeding the Zacks Consensus Estimate of $37.9 million [8]. - Axatilimab-csfr (Niktimvo) recorded $45.8 million in sales, up 27% sequentially, following its launch in Q1 2025 [9]. - Jakavi royalty revenues from Novartis rose 9% to $125.6 million, beating the Zacks Consensus Estimate of $119.2 million [10]. Expenses and Cash Position - Adjusted R&D expenses totaled $467 million, down 11% year-over-year, primarily due to a prior milestone payment [14]. - Adjusted SG&A expenses were $308 million, up 11% year-over-year, driven by increased international marketing activities [15]. - As of September 30, 2025, Incyte's cash, cash equivalents, and marketable securities amounted to $2.9 billion, up from $2.4 billion as of June 30, 2025 [15]. Market Outlook - Estimates for Incyte have trended upward, with a consensus estimate shift of 9.57% in the past month [16]. - Incyte holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [18].
INCY's Q3 Earnings & Revenues Beat Estimates on Higher Product Sales
ZACKS· 2025-10-28 16:11
Core Insights - Incyte Corporation reported third-quarter 2025 adjusted earnings of $2.26 per share, exceeding the Zacks Consensus Estimate of $1.66 and more than doubling from $1.07 per share in the same quarter last year [1][9] - Total revenues for the third quarter reached $1.37 billion, reflecting a 20% year-over-year growth, driven by strong performance from Jakafi and Opzelura, and surpassing the Zacks Consensus Estimate of $1.26 billion [2][9] Revenue Breakdown - Jakafi sales amounted to $791.1 million, a 7% increase year-over-year, attributed to a 10% rise in paid demand, beating the Zacks Consensus Estimate of $770 million [3][9] - Opzelura cream generated $188 million in sales, up 35% year-over-year, driven by increased patient demand, exceeding the Zacks Consensus Estimate of $179.1 million [4][9] - Newly approved Zynyz generated $22.7 million in sales, significantly higher than the year-ago quarter and beating the Zacks Consensus Estimate of $9.5 million [5][9] - Minjuvi's revenues totaled $42 million, a 34% year-over-year increase, surpassing the Zacks Consensus Estimate of $37.9 million [6][9] - Niktimvo recorded $45.8 million in sales, up 27% sequentially, following its launch in the U.S. [7][9] Market Performance - Incyte's shares have increased by 34.8% year-to-date, outperforming the industry growth of 10.3% [8] Financial Guidance - The company revised its 2025 guidance for Jakafi revenues to a range of $3.05-$3.075 billion, up from the previous range of $3-$3.05 billion, while maintaining the guidance for Opzelura revenues at $630-$670 million [16]
Incyte (INCY) Reports Q3 Earnings: What Key Metrics Have to Say
ZACKS· 2025-10-28 14:30
Core Insights - Incyte reported a revenue of $1.37 billion for Q3 2025, marking a year-over-year increase of 20.1% and exceeding the Zacks Consensus Estimate of $1.26 billion by 8.71% [1] - The company's EPS for the quarter was $2.26, up from $1.07 a year ago, representing a surprise of 36.14% compared to the consensus estimate of $1.66 [1] Revenue Breakdown - Product revenues reached $1.15 billion, surpassing the average estimate of $1.09 billion, with a year-over-year change of 19.4% [4] - Product royalty revenues totaled $171.12 million, exceeding the estimated $164.43 million, reflecting a 9.1% increase year-over-year [4] - Net product revenues for Iclusig were $37.58 million, above the $30.63 million estimate, showing a 26.4% year-over-year increase [4] - Net product revenues for Pemazyre were $22.74 million, slightly above the $21.99 million estimate, with a 10.1% year-over-year change [4] - Net product revenues for Minjuvi/Monjuvi reached $41.99 million, exceeding the $37.87 million estimate, representing a 33.6% year-over-year increase [4] - Net product revenues for Opzelura were $187.97 million, surpassing the $179.13 million estimate, with a year-over-year change of 35% [4] - Net product revenues for Jakafi were $791.07 million, above the $769.99 million estimate, reflecting a 6.7% year-over-year increase [4] - Net product revenues for Niktimvo were $45.83 million, exceeding the estimate of $42.68 million [4] - Net product revenues for Zynyz were $22.67 million, significantly above the $9.46 million estimate, showing a remarkable year-over-year change of 3167.2% [4] - Royalty revenues for Olumiant were $37.11 million, slightly below the estimate of $37.17 million, with a year-over-year change of 6.7% [4] - Royalty revenues for Tabrecta were $6.51 million, below the estimate of $7.15 million, reflecting a 9.9% year-over-year change [4] - Royalty revenues for Jakavi were $125.65 million, exceeding the estimate of $119.18 million, with an 8.6% year-over-year increase [4] Stock Performance - Incyte's shares have returned +11% over the past month, outperforming the Zacks S&P 500 composite's +3.6% 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 Gears Up to Report Q3 Earnings: Is a Beat in the Cards?
ZACKS· 2025-10-24 15:02
Core Viewpoint - Incyte Corporation (INCY) is expected to exceed expectations in its third-quarter 2025 earnings report, with revenue estimates at $1.26 billion and earnings at $1.66 per share [1]. Group 1: Revenue Drivers - Incyte's primary revenue source is from Jakafi (ruxolitinib) sales in the U.S., with strong sales momentum anticipated across all approved indications [2][5]. - The Zacks Consensus Estimate for Jakafi's third-quarter sales is projected at $770 million, with higher royalties expected from Novartis due to increased Jakavi sales outside the U.S. [3][5]. - Additional revenue contributions are expected from Opzelura, with a sales estimate of $179.1 million, and from other drugs like Minjuvi, Pemazyre, and Iclusig, with respective sales estimates of $37.9 million, $22 million, and $30.6 million [7][10]. Group 2: Recent Developments - Incyte's recent approvals, including Niktimvo and Monjuvi's expanded use, are likely to enhance product sales [5][9]. - The company has entered into an asset purchase agreement with MorphoSys AG, gaining exclusive global rights to tafasitamab, which is expected to boost sales following FDA approval for a new cancer indication [9]. Group 3: Financial Performance - Year-to-date, Incyte's shares have increased by 29.3%, outperforming the industry growth of 9.3% [4]. - Incyte has a mixed earnings surprise history, with two earnings beats and two misses in the last four quarters, averaging a surprise of 4.2% [15]. Group 4: Earnings Expectations - The Earnings ESP for Incyte is +3.48%, indicating a potential earnings beat, with the most accurate estimate at $1.72 compared to the consensus estimate of $1.66 [17].
Will Positive Regulatory Updates Further Boost INCY Stock?
ZACKS· 2025-10-20 14:31
Core Insights - Incyte (INCY) has demonstrated strong performance year-to-date, driven by better-than-expected quarterly results and positive updates regarding its pipeline and regulatory approvals [1] Group 1: Drug Performance - Incyte's lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for multiple indications, including polycythemia vera and myelofibrosis, with strong sales momentum expected to continue [2][3] - The FDA's approval of Opzelura, a cream formulation of ruxolitinib for atopic dermatitis, has significantly boosted Incyte's revenue, with strong uptake driven by increased patient demand [4][5] - Jakafi continues to drive Incyte's revenues with solid sales across all approved uses, while Opzelura's label expansion enhances top-line growth [9] Group 2: Pipeline and Regulatory Updates - Incyte's efforts to diversify its portfolio with new drugs like Pemazyre, Monjuvi, and Tabrecta are contributing to top-line growth [6] - Monjuvi has received new approvals for treating relapsed or refractory follicular lymphoma, which is expected to enhance its sales [7][8] - The FDA approved a label expansion for Zynyz, a PD-1 inhibitor, for advanced squamous cell carcinoma, further strengthening Incyte's oncology portfolio [10] Group 3: Collaborations and Future Prospects - Incyte's collaboration with Qiagen aims to develop a novel diagnostic panel for myeloproliferative neoplasms, which could support its pipeline of investigational treatments [11][12] - The company is looking to diversify and strengthen its portfolio under new leadership, with potential label expansions and new drug launches expected to generate incremental revenues [13]
Is Incyte Stock Outperforming the S&P 500?
Yahoo Finance· 2025-09-23 13:53
Core Insights - Incyte Corporation is a biopharmaceutical company focused on oncology, inflammation, and autoimmune diseases, with a market cap of $16.5 billion and a portfolio that includes drugs like Jakafi, Monjuvi, Pemazyre, and Opzelura [1][2] Company Performance - Incyte's shares are currently trading 3.7% below their 52-week high of $87.99, reached on September 4, and have surged 23.8% over the past three months, outperforming the S&P 500 Index's 12.2% return during the same period [3] - Over the past 52 weeks, Incyte's stock has rallied 28.9%, compared to the S&P 500's 17.4% increase, and on a year-to-date basis, shares are up 22.7%, while the S&P 500 has risen 13.8% [4] Financial Performance - Incyte reported a strong Q2 earnings release on July 29, with quarterly revenue improving 16.5% year-over-year to $1.2 billion, surpassing consensus estimates by 6.1%. The adjusted EPS was $1.57, a significant turnaround from a loss of $1.82 in the same period last year, and 12.9% ahead of analyst expectations [5] Market Position - Despite outperforming the broader market, Incyte has lagged behind its rival Alnylam Pharmaceuticals, which saw a 67.6% increase over the past 52 weeks and a 95% rise year-to-date [6] - Analysts maintain a moderately optimistic outlook for Incyte, with a consensus rating of "Moderate Buy" from 26 analysts. The stock is trading above its mean price target of $83.28, with a Street-high price target of $110, indicating a potential upside of 29.8% from current levels [7]
INCY Announces New Late-Stage Data on Skin Disease Drug
ZACKS· 2025-09-17 14:41
Core Insights - Incyte (INCY) announced new 24-week interim data from the STOP-HS program for its pipeline candidate, povorcitinib, in adult patients with moderate to severe hidradenitis suppurativa (HS) [1][7] - The data will be presented at the EADV 2025 Congress, supporting planned regulatory submissions in Europe and the United States in 2025 and early 2026, respectively [2][4] Pipeline and Clinical Data - Povorcitinib is an oral small-molecule JAK1 selective inhibitor targeting HS, a chronic inflammatory skin disease characterized by painful nodules and abscesses [2] - The STOP-HS clinical trial program includes two phase III studies, STOP-HS1 and STOP-HS2, evaluating the efficacy and safety of povorcitinib [4] - New data showed that nearly 60% of efficacy-evaluable patients achieved Hidradenitis Suppurativa Clinical Response (HiSCR)50 at week 24 [5][7] - Patients treated with povorcitinib also reported significant improvements in skin pain, with 62-70% achieving mild or no pain at week 24 [8] Safety Profile - The overall safety profile of povorcitinib remained consistent, with both doses well tolerated across the trials [10] - Treatment-emergent adverse events occurred in 42.4–54.3% of patients transitioning from placebo to povorcitinib at week 12, and in 70.2–78.7% of patients initially randomized to povorcitinib through week 24 [10] Market Performance - Year to date, Incyte's shares have gained 21.5%, outperforming the industry growth of 4.5% [2] - The successful development of povorcitinib is expected to significantly boost Incyte's revenue base, which is currently heavily dependent on its lead drug, Jakafi [12]
INCY's Q2 Earnings & Revenues Beat Estimates on Higher Product Sales
ZACKS· 2025-07-29 16:45
Core Insights - Incyte Corporation reported strong second-quarter 2025 results, with adjusted earnings of $1.57 per share, surpassing the Zacks Consensus Estimate of $1.39, and a significant improvement from an adjusted loss of $1.82 per share in the same quarter last year [2][10] Financial Performance - Total revenues for the second quarter reached $1.22 billion, reflecting a 16% year-over-year growth, driven by the performance of Jakafi and Opzelura, and exceeding the Zacks Consensus Estimate of $1.15 billion [3][10] - Jakafi sales amounted to $763.8 million, an 8% increase from the previous year, beating the Zacks Consensus Estimate of $744.1 million [4][10] - Opzelura cream generated $164.5 million in sales, a 35% year-over-year increase, surpassing the Zacks Consensus Estimate of $148.6 million [5][10] - Newly approved Zynyz generated $8.9 million in sales, significantly up from the previous year and exceeding the Zacks Consensus Estimate of $2.7 million [6] - Iclusig sales were $32.7 million, up 22% year over year, beating the Zacks Consensus Estimate of $29 million [6] - Pemazyre sales reached $22.2 million, reflecting a 9% increase and surpassing the Zacks Consensus Estimate of $20.2 million [6] - Minjuvi's revenues were $31.1 million, flat year over year, missing the Zacks Consensus Estimate of $34.3 million [7] - Axatilimab-csfr (Niktimvo) recorded $36.2 million in sales in its second quarter post-launch [8] Guidance and Future Outlook - The company raised its 2025 guidance for Jakafi revenues to a range of $3-$3.05 billion, up from the previous estimate of $2.95-$3 billion, while maintaining Opzelura's guidance at $630-$670 million [10][18] - Adjusted R&D expenses are now expected to be between $1.82-$1.84 billion, an increase from the prior guidance of $1.78-$1.81 billion [18] - Adjusted SG&A expenses are projected to be in the range of $1.16-$1.19 billion [18] Market Performance - Incyte's shares have increased by 1.6% year to date, outperforming the industry growth of 0.6% [9]
Incyte (INCY) Reports Q2 Earnings: What Key Metrics Have to Say
ZACKS· 2025-07-29 14:31
Core Insights - Incyte reported $1.22 billion in revenue for Q2 2025, a 16.5% year-over-year increase, with an EPS of $1.57 compared to -$1.82 a year ago, exceeding Zacks Consensus Estimates for both revenue and EPS [1] - The company’s revenue and EPS surprises were +5.56% and +12.95% respectively, indicating stronger performance than analysts anticipated [1] Revenue Breakdown - Product royalty revenues reached $151.12 million, surpassing the estimated $145.98 million, reflecting a 10.2% increase year-over-year [4] - Net product revenues for Iclusig were $32.73 million, exceeding the $28.99 million estimate, marking a 21.8% year-over-year growth [4] - Total net product revenues amounted to $1.06 billion, above the $985.29 million estimate, showing a 16.9% increase year-over-year [4] - Net product revenues for Pemazyre were $22.19 million, compared to the $20.24 million estimate, representing a 9.5% year-over-year change [4] - Net product revenues for Minjuvi/Monjuvi were $31.13 million, slightly below the $34.25 million estimate, with a minimal year-over-year change of 0.1% [4] - Net product revenues for Opzelura reached $164.5 million, exceeding the $148.56 million estimate, reflecting a significant 35.2% year-over-year increase [4] - Net product revenues for Jakafi were $763.79 million, surpassing the $744.1 million estimate, with an 8.2% year-over-year growth [4] - Net product revenues for Zynyz were $8.92 million, significantly above the $2.73 million estimate, indicating a remarkable 1270.4% year-over-year increase [4] - Royalty revenues for Olumiant were $33.48 million, slightly below the $33.57 million estimate, with a 5.6% year-over-year increase [4] - Royalty revenues for Tabrecta were $6.63 million, below the $6.88 million estimate, reflecting a 25.2% year-over-year increase [4] - Royalty revenues for Jakavi were $109.71 million, exceeding the $103.35 million estimate, with a 10.5% year-over-year change [4] - Net product revenues for Niktimvo were $36.15 million, significantly above the $20.33 million estimate [4] Stock Performance - Incyte's shares returned +3% over the past month, compared to the Zacks S&P 500 composite's +3.6% change, indicating a performance in line with the broader market [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the market in the near term [3]