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Incyte(INCY) - 2024 Q3 - Quarterly Report
2024-10-29 20:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-12400 INCYTE CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3136539 (Stat ...
Incyte(INCY) - 2024 Q3 - Earnings Call Transcript
2024-10-29 17:30
Financial Data and Key Metrics Changes - Total revenues increased by 24% year-over-year to $1.1 billion, with net product revenues growing 23% driven by demand for Jakafi and Opzelura [6][34] - Jakafi net product revenues were $741 million for Q3, reflecting a 16% year-over-year increase, with total demand up 10% [11][35] - Opzelura net product revenues were $139 million, representing a 52% year-over-year increase [13][36] Business Line Data and Key Metrics Changes - Jakafi's growth was driven by patient growth across all indications, with significant contributions from polycythemia vera and graft-versus-host disease [12] - Opzelura's growth was attributed to new patient starts and refills across atopic dermatitis and vitiligo, with European sales contributing $20 million [14][37] Market Data and Key Metrics Changes - The company anticipates that Niktimvo for chronic graft-versus-host disease, tafasitamab for follicular lymphoma, and retifanlimab for SCAC could collectively generate over $800 million in incremental revenues by 2029 [15] - The myelofibrosis market saw a 4% increase in total patients, with Jakafi continuing to grow due to earlier treatment initiation [84] Company Strategy and Development Direction - The company is focused on executing a pipeline of potential first or best-in-class medicines, with plans for over 10 high-impact launches by 2030 [17] - The strategy includes expanding the opportunity for ruxolitinib cream with additional indications and advancing multiple programs in inflammation and immunity [21][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong commercial performance and pipeline progress, highlighting the FDA approval of Niktimvo and positive clinical trial results [5][7] - The company raised its full-year 2024 Jakafi net revenue guidance to a range of $2.74 billion to $2.77 billion based on strong demand [42] Other Important Information - Total GAAP R&D expenses for Q3 were $573 million, influenced by a $100 million milestone payment [38] - Total GAAP SG&A expenses were $309 million, reflecting a 15% year-over-year increase [41] Q&A Session Summary Question: Insights on povorcitinib's Phase 3 data in hidradenitis - Management indicated that replicating strong Phase 2 data would provide a favorable efficacy profile for povorcitinib [45][46] Question: Development strategy for the BET inhibitor - The company remains confident in its BET inhibitor's data and plans to advance into Phase 3 studies [50][52] Question: Commercial dynamics for Opzelura in pediatric AD - Management is optimistic about formulary access and reimbursement for Opzelura in the pediatric market [63] Question: Rationale for HiSCR75 as the primary endpoint in HS Phase 3 - The decision was made to control for placebo effects and address unmet needs in mild to moderate HS [66] Question: Updates on the CDK2 program and pivotal plans - The company is exploring both platinum-sensitive and platinum-refractory settings for ovarian cancer treatment [92][96]
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
Incyte (INCY) came out with quarterly earnings of $1.07 per share, missing the Zacks Consensus Estimate of $1.12 per share. This compares to earnings of $1.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -4.46%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $0.78 per share when it actually produced a loss of $1.82, delivering a surprise of -333.33%.Over the last four quarters, the compa ...
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 ...