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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]
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]
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]
JNJ's Rybrevant-Lazcluze Combo Outshines AZN's Tagrisso in Lung Cancer
ZACKS· 2025-03-31 14:42
Recent Developments Related to JNJ's Rybrevant J&J (JNJ) recently reported new positive data from the phase III MARIPOSA study, which compared the combination of Rybrevant and Lazcluze against AstraZeneca's (AZN) Tagrisso in first-line EGFR-mutated non-small cell lung cancer ("NSCLC"). Data from the study suggests that the Rybrevant-Lazcluze combo significantly extends overall survival ("OS") in NSCLC patients with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution (L858R) mutations. At a median ...