Incyte(INCY)

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Incyte Clocks Mixed Q3 Earnings, But Analyst Sees A Strong Quarter For Jakafi And Opzelura
Benzinga· 2024-10-29 16:07
On Tuesday, Incyte Corporation INCY reported third-quarter revenue of $1.14 billion, up 24% year over year and beating the consensus of $1.08 billion. The company reported adjusted EPS of $1.07, down from $1.10 a year ago and missing the consensus estimate of $1.09. Jakafi (ruxolitinib) net product revenues increased to $741.18 million, up 16% year over year, primarily due to a 10% increase in total demand. Channel inventory at the end of the third quarter of 2024 was within the normal range. For the quarte ...
Here's What Key Metrics Tell Us About Incyte (INCY) Q3 Earnings
ZACKS· 2024-10-29 14:35
Incyte (INCY) reported $1.14 billion in revenue for the quarter ended September 2024, representing a year-over-year increase of 23.8%. EPS of $1.07 for the same period compares to $1.10 a year ago.The reported revenue represents a surprise of +4.47% over the Zacks Consensus Estimate of $1.09 billion. With the consensus EPS estimate being $1.12, the EPS surprise was -4.46%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street e ...
Incyte (INCY) Q3 Earnings Miss Estimates
ZACKS· 2024-10-29 13:16
Company Performance - Incyte reported quarterly earnings of $1.07 per share, missing the Zacks Consensus Estimate of $1.12 per share, and down from $1.10 per share a year ago, representing an earnings surprise of -4.46% [1] - The company posted revenues of $1.14 billion for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.47%, and up from $919.03 million year-over-year [2] - Over the last four quarters, Incyte has not surpassed consensus EPS estimates, but has topped consensus revenue estimates two times [2] Stock Outlook - Incyte shares have added about 4.6% since the beginning of the year, underperforming the S&P 500's gain of 22.1% [3] - The company's earnings outlook, including current consensus earnings expectations for upcoming quarters, will be crucial for stock performance [4] - The current consensus EPS estimate for the coming quarter is $1.64 on $1.17 billion in revenues, and $1.44 on $4.18 billion in revenues for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Incyte belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Incyte's stock performance [5][6]
Incyte(INCY) - 2024 Q3 - Quarterly Results
2024-10-29 11:05
Financial Performance - Total revenues for Q3 2024 reached $1,138 million, representing a 24% year-over-year increase[2]. - Total GAAP revenues for Q3 2024 reached $1,137,871, a 24% increase from $919,025 in Q3 2023[29]. - Total net product revenues increased by 23% in Q3 2024, totaling $962,992, compared to $783,197 in Q3 2023[30]. - Total revenues for the three months ended September 30, 2024, were $1,137,871, representing a 24% increase from $919,025 in the same period of 2023[61]. - Product revenues, net, reached $962,992 for the three months ended September 30, 2024, up from $783,197, marking a 23% increase year-over-year[61]. - GAAP net income for Q3 2024 was $106,456, down from $171,269 in Q3 2023[29]. - Net income for the three months ended September 30, 2024, was $106,456, compared to $171,269 in the same period of 2023, reflecting a decrease of 38%[61]. - Non-GAAP net income for the three months ended September 30, 2024, was $209,651, compared to $248,719 in the same period of 2023, indicating a decrease of 16%[65]. Product Revenues - Jakafi (ruxolitinib) net product revenues were $741 million in Q3 2024, up 16% year-over-year, with full year 2024 guidance raised to $2,740 - $2,770 million[2][9]. - Opzelura (ruxolitinib) cream net product revenues totaled $139 million in Q3 2024, reflecting a 52% year-over-year growth, driven by strong demand in the U.S. and reimbursement expansion in Europe[2][10]. - Jakafi net product revenue grew by 16% in Q3 2024, reaching $741,181, driven by a 10% increase in total demand[30]. - Opzelura net product revenue surged by 52% in Q3 2024, totaling $139,272, due to growth in new patient starts and refills[31]. Research and Development - Research and development expenses increased by 53% in Q3 2024, totaling $573,174, primarily due to a $100 million milestone payment[34]. - Research and development expenses for the three months ended September 30, 2024, were $573,174, a significant increase of 53% compared to $375,709 in the same period of 2023[61]. - The company is focused on developing new transformative therapies for myeloid disease and has a strong pipeline of products[59]. - Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in squamous cell anal carcinoma by the end of 2024, with potential approval in 2025[5]. - The Phase 3 trial for tafasitamab in relapsed or refractory follicular lymphoma met its primary endpoint, with an sBLA expected to be filed by the end of 2024[8]. - Ongoing trials for ruxolitinib cream in prurigo nodularis and hidradenitis suppurativa are expected to yield data in the first half of 2025[19]. - Incyte is enrolling patients in multiple Phase 2 and Phase 3 trials for various indications, with initial data anticipated in 2025[22]. Financial Guidance - Incyte raised its full year 2024 Jakafi revenue guidance to $2,740 - $2,770 million, up from $2,710 - $2,750 million[42]. - The full year GAAP research and development expenses guidance is now $2,545 - $2,590 million, increased from $2,445 - $2,490 million[42]. - The company is maintaining its full year 2024 cost of product revenue guidance at 7-8% of net product revenues[42]. - Incyte's guidance does not include revenue from potential new product launches or the impact of one-time items[41]. - The company reported milestone revenues of $18,000 for the three months ended September 30, 2024, compared to $5,000 in the same period of 2023[65]. Cash and Assets - Cash, cash equivalents, and marketable securities decreased from $3.7 billion at the end of 2023 to $1.8 billion by September 30, 2024, largely due to a $2.0 billion share repurchase[40]. - Cash, cash equivalents, and marketable securities decreased to $1,771,344 as of September 30, 2024, down from $3,656,043 at the end of 2023[63]. - Total assets decreased to $5,012,434 as of September 30, 2024, compared to $6,782,107 at the end of 2023[63]. - Stockholders' equity declined to $3,171,220 as of September 30, 2024, from $5,189,837 at the end of 2023[63].
Incyte Gains 12.7% Year to Date: How Should You Play the Stock?
ZACKS· 2024-09-25 19:01
Shares of Incyte (INCY) have risen 12.7% in the past six months against the industry's decline of 0.5%. The stock has also outperformed the sector and the S&P 500 during this time frame. The outperformance can be attributed to positive data readouts and new drug approvals. Lead drug Jakafi (ruxolitinib) also maintains momentum. INCY Outperforms Industry, Sector and S&P 500 Image Source: Zacks Investment Research INCY's Lead Drug Jakafi Maintains Momentum Incyte's lead drug, Jakafi, is a JAK1/JAK2 inhibitor ...
Incyte and Syndax Announce New England Journal of Medicine Publication of Data from Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease
Prnewswire· 2024-09-18 21:15
– Trial met its primary endpoint across all dose cohorts with 74% of patients at the 0.3 mg/kg every 2 weeks dose achieving a complete or partial response within the first six months of treatment – – Niktimvo approved by U.S. FDA for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg – – Niktimvo added to latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatme ...
Incyte Downgraded - Analyst Notes Intense Competition, Particularly In Larger Markets
Benzinga· 2024-09-18 18:44
Truist Securities has downgraded Incyte Corporation INCY, noting Jakafi's (ruxolitinib) patent loss approaching in 2028. Jakafi is Incyte's top-selling drug. It is indicated for polycythemia vera in adults, intermediate or high-risk myelofibrosis in adults, and steroid-refractory acute graft versus host disease in adult and pediatric patients. In second quarter 2024, the drug generated sales of $705.9 million, +3% year-over-year, driven by a 9% increase in paid demand. The analyst downgraded the stock from ...
Incyte Announces Promising New Data on Oncology Candidate at ESMO
ZACKS· 2024-09-16 18:26
Incyte (INCY) announced new data from a phase I study on pipeline candidate INCB123667 in patients with advanced solid tumors. INCB123667 is a highly selective, potential first-in-class CDK2 inhibitor. The new data was presented during a mini-oral presentation at the European Society of Medical Oncology. The updated data highlight the potential of the candidate as a differentiated treatment option for cancers with increased cyclin E1 activity, amplification and/or overexpression in cells predictive of CDK2 ...
Incyte (INCY) Update / Briefing Transcript
2024-09-14 18:02
Incyte (INCY) Update Summary Company Overview - **Company**: Incyte Corporation - **Event**: Investor Event at ESMO 2024 - **Date**: September 14, 2024 Key Points Industry and Company Focus - Incyte is focusing on oncology, specifically targeting gynecological cancers and squamous cell anal cancer with their drug candidates, including retifanlimab and a new CDK2 inhibitor [2][3][4][5][6][9][31][41]. Core Programs and Data Updates - **Retifanlimab**: - Positive pivotal data presented for squamous cell anal cancer, showing a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for placebo, with a hazard ratio of 0.63 [24][30]. - The study design included a combination of retifanlimab with chemotherapy for patients with advanced disease [21][22]. - **CDK2 Inhibitor**: - Focused on ovarian and endometrial cancers, with plans to initiate pivotal trials in 2025 [10][43][60]. - The drug targets cyclin E overexpression, which is prevalent in HRD negative ovarian cancer patients [35][44][63]. - Early data shows a response rate of 31% in heavily pretreated ovarian cancer patients, with a disease control rate of 75% [56][60]. Pipeline and Milestones - Incyte has several near-term milestones, including: - Approval of axatilamab for chronic graft versus host disease [5][71]. - Submission for pediatric atopic dermatitis for OPSILURA [71]. - Potential approval of retifanlimab in new indications, including anal cancer and non-small cell lung cancer [71][72]. - Ongoing discussions for regulatory strategies for the CDK2 inhibitor in platinum-resistant ovarian cancer [66][69]. Market Dynamics and Competitive Landscape - The incidence of anal cancer is increasing by approximately 3% annually, largely due to HPV [14][15]. - Current treatment options for advanced anal cancer are limited, with chemotherapy being the standard of care [18][19]. - In ovarian cancer, there is a significant unmet need for effective treatments, especially in HRD negative patients, where current therapies have limited efficacy [32][34][63]. Safety and Efficacy - Safety data from the CDK2 inhibitor trials indicate manageable adverse events, primarily hematological toxicities, with few discontinuations due to treatment-related issues [50][51]. - The combination of retifanlimab with chemotherapy has shown promising results without compromising the delivery of chemotherapy [30][60]. Future Directions - Incyte aims to position the CDK2 inhibitor as a new standard of care in ovarian cancer, particularly in combination with existing therapies like bevacizumab [38][41][60]. - The company is also exploring the potential of retifanlimab in other cancer types and is preparing for commercial launches in 2025 [71][80]. Additional Insights - The company is leveraging its existing infrastructure from previous drug launches to facilitate the introduction of new therapies [78][80]. - There is a focus on developing companion diagnostics to identify patients who would benefit most from the CDK2 inhibitor [84][86]. This summary encapsulates the critical insights and developments from Incyte's recent investor event, highlighting the company's strategic focus on oncology and the promising data emerging from its clinical trials.
Incyte (INCY) Up 0.9% Since Last Earnings Report: Can It Continue?
ZACKS· 2024-08-29 16:37
It has been about a month since the last earnings report for Incyte (INCY) . Shares have added about 0.9% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Incyte due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Incyte's Q2 Earnings Lag Estimates, Revenues Top Inc ...