Incyte(INCY)
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Incyte(INCY) - 2025 Q3 - Quarterly Results
2025-10-28 11:04
Exhibit 99.1 FOR IMMEDIATE RELEASE Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates Total revenues of $1.37 billion in the third quarter of 2025, reflecting 20% growth compared to the third quarter of 2024 Jakafi (ruxolitinib) net product revenue of $791 million, an increase of 7% compared to the same period in 2024 ® Opzelura (ruxolitinib) cream net product revenue of $188 million, an increase of 35% compared to the prior year period ® Hematology-Oncology portfolio net prod ...
Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis
Businesswire· 2025-10-25 23:55
Core Insights - Incyte has announced new data from the Phase 3b TRuE-AD4 trial of Opzelura® (Ruxolitinib Cream) for adults with moderate atopic dermatitis, indicating positive outcomes in treatment efficacy [1] Group 1: Trial Results - The Phase 3b TRuE-AD4 trial demonstrated significant improvements in the severity of atopic dermatitis among participants using Opzelura® compared to the control group [1] - The data suggests that Opzelura® is effective in reducing the symptoms of moderate atopic dermatitis, which may enhance its market potential [1] Group 2: Market Implications - The positive trial results could lead to increased adoption of Opzelura® in clinical practice, potentially boosting Incyte's revenue from this product line [1] - As the demand for effective treatments for atopic dermatitis grows, Incyte may strengthen its position in the dermatology market [1]
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].
Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial
Prnewswire· 2025-10-24 10:45
Core Insights - The BRAVE-AA-PEDS trial is the first and largest study focused on children and adolescents with severe alopecia areata, showing that 71% of adolescents treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year [1][2][4] - Eli Lilly plans to submit the trial data to global regulators for a potential label update for baricitinib, commercially known as Olumiant [1][9][10] Group 1: Trial Results - At one year, 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth, defined as 80% or more scalp hair coverage [7] - Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth [7] - In a post-hoc analysis, 80% of adolescents diagnosed with severe AA less than two years before treatment achieved successful hair regrowth with baricitinib 4 mg [4] Group 2: Safety Profile - The safety profile of baricitinib in adolescents was consistent with that seen in adult trials, with no new safety signals observed after one year [5][8] - Common treatment-emergent adverse events included acne, upper respiratory tract infection, and influenza, with no deaths or major adverse cardiovascular events reported [5][8] Group 3: Future Plans and Context - Lilly intends to enroll a new cohort of children ages 6 to under 12 in the BRAVE-AA-PEDS trial in the next year [9][12] - Baricitinib is the most-researched JAK inhibitor in alopecia areata, with over 1,300 adults and 423 adolescents enrolled in clinical trials [10]
Incyte Stock: Strong Growth, Margin Expansion And Low Valuation (NASDAQ:INCY)
Seeking Alpha· 2025-10-22 03:13
Core Insights - The article emphasizes the focus on growth and momentum stocks that are reasonably priced and expected to outperform the market in the long term [1] - It highlights a significant investment opportunity, noting that the S&P 500 increased by 367% and the Nasdaq by 685% from March 2009 to 2019, indicating a strong recovery from the financial crisis [1] Investment Strategy - The investment approach involves long-term investment in quality stocks, with the use of options as part of the strategy [1] - The article suggests that investors should consider high-quality growth stocks to enhance their investment returns [1] Market Context - The performance data provided serves as a historical context for potential future investments, illustrating the substantial gains that can be achieved in the stock market following a downturn [1]
Incyte's Quarterly Earnings Preview: What You Need to Know
Yahoo Finance· 2025-10-21 12:55
Core Insights - Incyte Corporation (INCY) is a biopharmaceutical company focused on hematology/oncology, inflammation, and autoimmunity, with a market cap of $16.8 billion, set to announce Q3 earnings on October 28, 2025 [1] Financial Performance - Analysts expect INCY to report a profit of $1.38 per share for Q3 2025, an increase of 89% from $0.73 per share in the same quarter last year [2] - For the full fiscal year, EPS is projected to be $5.14, a significant rise from $0.08 in fiscal 2024, with an expected 25.1% year-over-year increase to $6.43 in fiscal 2026 [3] Stock Performance - INCY stock has increased by 29.8% over the past 52 weeks, outperforming the S&P 500 Index's 14.8% gains and the Health Care Select Sector SPDR Fund's 5.5% losses [4] - The stock's performance is attributed to strong sales of Jakafi and the successful launch of Opzelura cream, along with recent FDA approvals for new treatments [5] Market Sentiment - Analysts maintain a "Moderate Buy" rating for INCY, with 11 out of 26 analysts recommending a "Strong Buy," 14 advising a "Hold," and one suggesting a "Strong Sell" [7] - The current trading price is above the mean price target of $85.67, with a Street-high price target of $115 indicating a potential upside of 33.5% [7]
Incyte Corporation (INCY) Discusses ESMO Data on TGF-beta Receptor by PD-1 Bispecific in Colorectal Cancer and G12D Inhibitor in Pancreatic Cancer Transcript
Seeking Alpha· 2025-10-20 21:24
Core Insights - The company is presenting updates on two solid tumor programs at ESMO 2025, focusing on a TGF-beta receptor II by PD-1 bispecific and a KRAS G12D inhibitor [1] - The presentation includes insights from key team members regarding the biological rationale and future plans for these programs [2] Group 1 - The solid tumor update is being held in Berlin, with both in-person and online attendance [1] - The two programs discussed are the TGF-beta receptor II by PD-1 bispecific and the KRAS G12D inhibitor, with data presented at the event [1] - The agenda includes presentations from the Chief Scientific Officer, Head of Early Development, and Chief Medical Officer, focusing on the biology, data sets, and future plans for the programs [2]
Are You Looking for a Top Momentum Pick? Why Incyte (INCY) is a Great Choice
ZACKS· 2025-10-20 17:00
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, with the aim of buying high and selling higher, capitalizing on established price movements [1]. Company Overview: Incyte (INCY) - Incyte currently holds a Momentum Style Score of B, indicating strong momentum characteristics [2]. - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for potential outperformance in the market [3]. Performance Metrics - Over the past week, Incyte's shares have increased by 4.5%, while the Zacks Medical - Biomedical and Genetics industry remained flat [5]. - Incyte's shares have risen by 24.74% over the past quarter and 31.9% over the last year, significantly outperforming the S&P 500, which increased by 6.14% and 15.41% respectively [6]. Trading Volume - The average 20-day trading volume for Incyte is 1,637,505 shares, which serves as a bullish indicator when combined with rising stock prices [7]. Earnings Outlook - In the last two months, two earnings estimates for Incyte have been revised upwards, while one has been revised downwards, leading to an increase in the consensus estimate from $6.01 to $6.15 [9]. - For the next fiscal year, there have been two upward revisions and one downward revision in earnings estimates [9]. Conclusion - Given the positive momentum indicators and earnings outlook, Incyte is recommended as a stock to consider for near-term investment opportunities [10].
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]
Incyte (NasdaqGS:INCY) 2025 Conference Transcript
2025-10-19 18:30
Summary of Incyte's 2025 Conference Call Company Overview - **Company**: Incyte Corporation (NasdaqGS: INCY) - **Event**: 2025 Conference Call held on October 19, 2025 - **Focus**: Update on two solid tumor programs: TGF receptor 2 by PD-1 bispecific and KRAS G12D inhibitor Key Points Industry and Company Focus - **Tumor Types**: - TGF receptor 2 by PD-1 bispecific targets microsatellite stable (MSS) colorectal cancer, which constitutes 80-90% of colorectal cancer patients [2][3] - KRAS G12D inhibitor focuses on pancreatic ductal adenocarcinoma (PDAC), specifically targeting the most common mutation in this patient population [4][48] Core Insights and Arguments - **TGF Receptor 2 by PD-1 Bispecific**: - MSS colorectal cancer has a significant unmet medical need as it does not respond to PD-1 inhibitors [2][3] - Previous trials showed a 0% response rate in three studies and only a 2% response in another for patients with MSS colorectal cancer [3] - The bispecific antibody INCA0890 is designed to target TGF receptor 2, which is a potent immunosuppressive factor in solid tumors [8][10] - The approach aims to selectively inhibit TGF signaling in tumor-infiltrating lymphocytes, avoiding systemic toxicity [24][25] - **KRAS G12D Inhibitor**: - No approved KRAS G12D inhibitors exist, presenting a unique opportunity for Incyte [4][48] - The G12D mutation is associated with a worse prognosis compared to wild-type patients [48] - The inhibitor shows potential for combination with standard chemotherapy regimens like gemcitabine/nab-paclitaxel and modified FOLFIRINOX [5][57] Clinical Data and Safety Profile - **TGF Bispecific**: - Phase 1 trial showed a favorable safety profile with only 4.6% of patients discontinuing due to treatment-related adverse events [36][39] - The majority of patients treated had advanced disease, with a median of 3 prior lines of therapy [36] - Efficacy data indicated responses in patients with liver metastases, which is unprecedented for immunotherapy in this context [42][46] - **KRAS G12D**: - Phase 1 trial demonstrated a 34% response rate and an 86% disease control rate among treated patients [54][66] - The safety profile was manageable, with no dose-limiting toxicities observed up to 1600 mg [51][52] - The drug showed deeper and quicker reductions in circulating tumor DNA (ctDNA) at higher doses, correlating with clinical responses [53] Market Opportunity and Future Plans - **MSS Colorectal Cancer**: - Represents a significant market with nearly 2 million diagnosed cases in the US, Western Europe, and Japan, and a dismal 16% five-year survival rate for stage 4 patients [62][63] - Incyte plans to initiate a Phase 3 trial in early 2026, focusing on first-line treatment in combination with standard chemotherapy [64][68] - **Pancreatic Ductal Adenocarcinoma**: - A rapidly progressive disease with a high mortality rate and limited treatment options [65] - Incyte aims to be the first targeted therapy for KRAS G12D patients, with plans to align with regulators for a registration program in 2026 [67][68] Additional Considerations - The TGF bispecific and KRAS G12D inhibitor programs are seen as strategic choices to address significant unmet medical needs in oncology [67][68] - The company is committed to a disciplined approach in capital allocation and program development based on emerging scientific data [74] This summary encapsulates the critical insights and future directions discussed during Incyte's 2025 conference call, highlighting the company's focus on innovative therapies for challenging cancer types.