Opzelura

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INCY Stock Trading Close to Its 52-Week High: Buy, Sell or Hold?
ZACKS· 2025-08-20 15:21
Key Takeaways Incyte touched a 52-week high of $87.24 on Aug. 18 after strong results and pipeline progress.Jakafi sales rose 15% to $1.5B in 1H 2025, while Opzelura jumped 37% to $283M.FDA approvals for Monjuvi and Zynyz expand Incytes oncology portfolio and boost growth.Incyte ((INCY) has put up a stupendous performance in the past month and touched a new 52-week high of $87.24 on Aug. 18. Nonetheless, the stock price dipped to $85.46 on the following day. Shares of the company have gained 26.8% compared ...
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]
Incyte(INCY) - 2025 Q2 - Earnings Call Presentation
2025-07-29 12:00
2025 Second Quarter Financial and Corporate Update July 29, 2025 Second Quarter 2025 Earnings Call Agenda Introduction Greg Shertzer Investor Relations R&D Update Pablo Cagnoni Head of Research & Development Commercial & Financial Results Christiana Stamoulis Chief Financial Officer Opening Remarks Bill Meury Chief Executive Officer Available for Q&A Matteo Trotta EVP, Head of U.S. Dermatology Mohamed Issa EVP, Head of U.S. Oncology Steven Stein Chief Medical Officer Closing Remarks Bill Meury Chief Executi ...
Incyte Gears Up to Report Q2 Earnings: Is a Beat in the Cards?
ZACKS· 2025-07-24 16:46
Core Viewpoint - Incyte Corporation (INCY) is expected to exceed expectations in its second-quarter 2025 earnings report, with revenue estimates at $1.15 billion and earnings at $1.40 per share [1]. Factors Likely to Influence INCY's Q2 Results - Incyte's primary revenue source is from its lead drug, Jakafi (ruxolitinib), with strong sales anticipated across all approved indications, although competition may limit growth [2]. - The Zacks Consensus Estimate for Jakafi's sales in Q2 is $744 million, with higher royalties expected from Novartis due to increased Jakavi sales outside the U.S. [3][4]. Sales Performance of Other Drugs - Opzelura's sales are projected to reach $149 million, driven by new patient starts and strong uptake in the EU [8]. - Additional contributions to revenue are expected from other drugs like Minjuvi, Pemazyre, and Iclusig, with respective sales estimates of $34.25 million, $20.24 million, and $28.99 million [11]. Recent Developments - The FDA approved Monjuvi for a new cancer indication, which is likely to enhance its sales performance [10]. - Niktimvo, launched in Q1 2025, recorded $13.6 million in sales, and further updates on its launch activities are anticipated [12][13]. Earnings Surprise History - Incyte has a mixed earnings surprise history, with one earnings beat in the last four quarters and an average negative surprise of 82.37% [14]. Earnings Predictions - The Earnings ESP for Incyte is +1.43%, indicating a potential earnings beat, supported by a Zacks Rank of 3 [15][16].
Incyte Gains 9.2% in Three Months: Buy, Hold or Sell the Stock?
ZACKS· 2025-07-01 14:36
Core Viewpoint - Incyte (INCY) has demonstrated strong performance over the past three months, with a 9.2% increase in share price, outperforming the industry which saw a decline of 1.3% [1][2][9] Pipeline and Regulatory Updates - Positive pipeline and regulatory updates have contributed to INCY's stock performance, including the FDA's approval of Monjuvi (tafasitamab-cxix) for a new cancer indication [3][4] - Monjuvi, in combination with Rituxan and Revlimid, is now approved for treating adult patients with relapsed or refractory follicular lymphoma, which is expected to boost sales [5] - Incyte secured worldwide exclusive rights for tafasitamab from MorphoSys AG in February 2024, enhancing its oncology portfolio [5] - A new collaboration with Qiagen aims to develop a diagnostic panel for myeloproliferative neoplasms (MPNs), supporting INCY's pipeline [6][7] Drug Performance - The FDA approved label expansions for both Monjuvi and Zynyz, further strengthening Incyte's oncology offerings [9] - Zynyz (retifanlimab-dlwr) received approval for use in combination with platinum-based chemotherapy for treating locally recurrent or metastatic squamous cell carcinoma of the anal canal [10] - The approval of Jakafi, a lead drug, continues to show strong sales across various indications, contributing significantly to revenue [13][14] Financial Estimates - INCY's shares currently trade at a price/sales ratio of 2.66x forward sales, lower than its historical mean of 4.23x but higher than the biotech industry average of 1.64x [20] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased to $5.78 from $5.81 over the past 60 days, with a similar downward trend for 2026 [22] Market Position and Challenges - Despite recent successes, INCY remains heavily dependent on Jakafi, which accounts for over 65% of total revenues, and faces increasing competition [16][24] - The company has appointed a new CEO, Bill Meury, which may influence future strategic directions and pipeline developments [24]
FDA Extends INCY's Application for Opzelura Label Expansion
ZACKS· 2025-06-23 14:56
Core Insights - Incyte's supplemental new drug application (sNDA) for ruxolitinib cream has had its FDA review period extended by three months to September 19, 2025, to allow for additional data review [1][2][7] - The sNDA aims to secure approval for treating children aged 2-11 years with mild to moderate atopic dermatitis (AD) [1][4] - Ruxolitinib cream, marketed as Opzelura, is already approved for patients aged 12 and older for the treatment of non-segmental vitiligo [3][5] Company Performance - Year-to-date, Incyte's shares have decreased by 0.9%, while the industry has seen a decline of 2.5% [2] - First-quarter net revenues from Opzelura cream reached $119 million, reflecting a 38% increase [5] Clinical Data - The sNDA is supported by data from the phase III TRuE-AD3 study, which demonstrated that a higher percentage of patients treated with Opzelura achieved treatment success compared to those using a non-medicated cream [4][7] - The study also met a secondary endpoint, with at least 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 [4] Portfolio Diversification - Incyte is actively working to diversify its portfolio and reduce reliance on its leading drug, Jakafi (ruxolitinib) [8] - The company has seen strong sales across all indications, with recent approvals of drugs like Pemazyre, Monjuvi, and Tabrecta contributing to this diversification [10] Competitive Landscape - Jakafi faces increasing competition, particularly from GSK's Ojjaara, which reported strong sales growth of £112 million in the first quarter of 2025 [13] - The patent protection for Jakafi is expected to expire in the coming years, which may impact future revenue [14]
Incyte(INCY) - 2025 Q1 - Earnings Call Presentation
2025-04-29 15:54
Financial Performance - Total revenues reached $1.053 billion, a 20% year-over-year increase[10, 44] - Product revenues amounted to $922 million, reflecting a 26% year-over-year growth[10, 44] - Jakafi net sales were $709 million, up 24% year-over-year, driven by strong patient demand[23, 46] - Opzelura net sales reached $119 million, a 38% year-over-year increase, fueled by U.S prescription growth and European launches[34, 48] - Niktimvo achieved $14 million in net sales during its initial U.S launch[36] Product & Pipeline Development - Jakafi's FY25 guidance raised to $2.95 - $3.0 billion[26] - Opzelura's FY25 guidance is $630 - $670 million[34] - Povorcitinib demonstrated positive Phase 2 results in CSU, with a planned discussion with the FDA to finalize Phase 3 design[15, 68] - The company anticipates having more than 10 high impact launches by 2030[5, 63] Financial Outlook - The company has $2.4 billion in cash[11] - GAAP Cost of product revenues is unchanged at 8.5 – 9% of net product revenues[60] - GAAP Research and development expenses is unchanged at $1.930 - $1.960 million[60]
Here's What Key Metrics Tell Us About Incyte (INCY) Q1 Earnings
ZACKS· 2025-04-29 14:35
Core Insights - Incyte reported $1.05 billion in revenue for Q1 2025, a 19.5% year-over-year increase, with an EPS of $1.16 compared to $0.64 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $1.01 billion by 4.66%, and the EPS also surpassed the consensus estimate of $1.01 by 14.85% [1] Revenue Performance - Net product revenues for Pemazyre were $18.44 million, below the average estimate of $21.62 million, representing a 4.3% year-over-year increase [4] - Total product revenues reached $922.27 million, exceeding the average estimate of $876.70 million, with a year-over-year change of 26.4% [4] - Iclusig generated $29.54 million in net product revenues, slightly above the average estimate of $28.67 million, but a 2.6% decrease year-over-year [4] - Minjuvi/Monjuvi reported $29.55 million, below the average estimate of $33.43 million, with a year-over-year increase of 23.8% [4] - Opzelura's net product revenues were $118.71 million, below the average estimate of $126.95 million, reflecting a 38.5% year-over-year increase [4] - Jakafi generated $709.41 million, surpassing the average estimate of $661.10 million, with a 24.1% year-over-year increase [4] - Zynyz reported $3.01 million, exceeding the average estimate of $1.92 million [4] Royalty Revenues - Jakavi's royalty revenues were $92.15 million, below the average estimate of $97.41 million, with a 2.9% year-over-year increase [4] - Total product royalty revenues reached $130.62 million, below the average estimate of $139.49 million, reflecting a 3.7% year-over-year increase [4] - Olumiant's royalty revenues were $30.80 million, below the average estimate of $34.90 million, with a 0.7% year-over-year change [4] - Tabrecta generated $6.41 million, exceeding the average estimate of $5.93 million, with a 22.5% year-over-year increase [4] Stock Performance - Incyte's shares returned -1.7% over the past month, compared to the S&P 500 composite's -0.8% 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]