Incyte (NasdaqGS:INCY) Q3 2025 Earnings Call October 28, 2025 08:00 AM ET Company ParticipantsAlexis Smith - VP and Head of Investor RelationsSteven Stein - Chief Medical OfficerMohamed Issa - EVP and General Manager, North AmericaAshish Verma - Initiative ManagerBill Meury - CEOPablo Cagnoni - PresidentTazim Ahmed - Account ManagerJames Shin - Director of Biopharm Equity ResearchTom Shea - CFOConference Call ParticipantsJessica Fye - Managing Director and Senior AnalystPeter Lawson - Managing Director and ...

Financial Data and Key Metrics Changes - The company reported total revenues of $1.37 billion and product sales of $1.15 billion, representing a 20% and 19% increase year-over-year, respectively [3][29] - GAAP R&D expenses were $507 million, with a 7% year-over-year increase when excluding one-time expenses from the prior year [29] - GAAP SG&A expenses were $329 million, reflecting a 6% increase year-over-year, primarily due to international marketing activities [29] - The company raised its full-year net product revenue guidance to a range of $4.23 billion to $4.32 billion [29] Business Line Data and Key Metrics Changes - Jakafi sales reached $791 million, a 7% increase, with strong demand growth of 10% year-over-year [4] - Opzelura sales were $188 million, a 35% increase year-over-year, with $144 million from the U.S., representing a 21% increase [5] - Niktimvo sales totaled $46 million, a 27% increase from the second quarter, with 90% of U.S. bone marrow transplant centers adopting the product [6][7] Market Data and Key Metrics Changes - International sales for Opzelura and vitiligo reached $44 million, a 117% increase from last year [6] - The branded non-steroidal topical market is expanding at a 20% rate, with Opzelura positioned to benefit from this trend [5] Company Strategy and Development Direction - The company is focusing on optimizing promotional strategies and investments for key products to drive future growth [3] - Upcoming product launches include Ruxolitinib XR, Opzelura AD in Europe, and povorcitinib in HS, which are expected to contribute significantly to future growth [9][10] - The company is conducting a thorough review of its pipeline to prioritize high-value programs and streamline operations [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of key products and emphasized the importance of demonstrating single-agent activity for new therapies [3][35] - The company is focused on maintaining financial discipline while investing in strategic growth drivers [14][70] - Management highlighted the potential of povorcitinib and other pipeline products to address significant medical needs and drive future growth [18][20] Other Important Information - The company is actively studying Niktimvo in combination with ruxolitinib and steroids, which could shift the standard of care in GVHD [8] - The company plans to submit an application for ruxolitinib cream in moderate AD in the EU by year-end, with potential approval in the second half of 2026 [6] Q&A Session Summary Question: Importance of mCALR data for efficacy - Management emphasized the need to demonstrate single-agent activity for the mCALR antibody program, with a focus on clinical and translational endpoints [33][35] Question: Termination of povorcitinib program at CSU - The decision was based on prioritizing projects with better return profiles, and data from the terminated program may still be presented at a future conference [39][40] Question: Sustainability of Naktinvo's growth trajectory - Management expressed confidence in Naktinvo's growth, noting broad adoption among transplant centers and a healthy margin profile [71][74] Question: Current pipeline maturity and growth post-Jakafi LOE - The company is focused on several key projects, including povorcitinib and mCALR, to drive growth and build a robust oncology portfolio [79][80]

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]

Core Insights - Incyte Corporation is a biopharmaceutical company focused on oncology, inflammation, and autoimmune diseases, with a market cap of $16.5 billion and a portfolio that includes drugs like Jakafi, Monjuvi, Pemazyre, and Opzelura [1][2] Company Performance - Incyte's shares are currently trading 3.7% below their 52-week high of $87.99, reached on September 4, and have surged 23.8% over the past three months, outperforming the S&P 500 Index's 12.2% return during the same period [3] - Over the past 52 weeks, Incyte's stock has rallied 28.9%, compared to the S&P 500's 17.4% increase, and on a year-to-date basis, shares are up 22.7%, while the S&P 500 has risen 13.8% [4] Financial Performance - Incyte reported a strong Q2 earnings release on July 29, with quarterly revenue improving 16.5% year-over-year to $1.2 billion, surpassing consensus estimates by 6.1%. The adjusted EPS was $1.57, a significant turnaround from a loss of $1.82 in the same period last year, and 12.9% ahead of analyst expectations [5] Market Position - Despite outperforming the broader market, Incyte has lagged behind its rival Alnylam Pharmaceuticals, which saw a 67.6% increase over the past 52 weeks and a 95% rise year-to-date [6] - Analysts maintain a moderately optimistic outlook for Incyte, with a consensus rating of "Moderate Buy" from 26 analysts. The stock is trading above its mean price target of $83.28, with a Street-high price target of $110, indicating a potential upside of 29.8% from current levels [7]

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]

Core Insights - Incyte Corporation is recognized as one of the best performing biotech stocks in 2025, focusing on oncology and autoimmune therapies through regulatory approvals and pipeline innovation [1][2]. Regulatory Approvals and Pipeline Developments - Incyte secured FDA approvals for Zynyz in squamous cell anal carcinoma and Monjuvi in follicular lymphoma, enhancing its hematology-oncology franchise [2]. - Positive Phase 1 results for INCA033989 in essential thrombocythemia have strengthened its position in myeloproliferative neoplasms, with upcoming presentations at ESMO Congress 2025 expected to showcase early data for two promising assets [2]. KRAS Cancer Program - The KRAS program is gaining significant attention, particularly with the experimental oral inhibitor INCB161734 targeting G12D-mutated KRAS, a challenging cancer mutation [3]. - Phase 1 results for this program are anticipated at ESMO, which could provide the first clinical proof of concept, positioning Incyte as a pioneer in cancer drug development [3].

Incyte FY Conference Summary Company Overview - **Company**: Incyte Corporation (NasdaqGS: INCY) - **Date of Conference**: September 09, 2025 - **Key Speakers**: Bill (CEO), Dr. Steven Stein Core Industry Insights - **Focus Areas**: Oncology and Immunology, specifically hematology and immune-mediated skin conditions [2][3] - **Market Potential**: Significant opportunities in myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) with a potential market size in the tens of billions of dollars [5][6] Key Points and Arguments 1. **Product Pipeline**: Incyte has five targeted therapies in development, with no current targeted therapies for MF, PV, or ET, indicating a potential for innovation in these areas [5] 2. **Patient Population**: Approximately 150,000 patients with mCALR mutations or JAK2 V617F mutations, with a market capture potential of 10% to 20% translating to significant revenue growth [5][7] 3. **Regulatory Strategy**: Plans to start Phase 3 trials for ET by mid-2026, with ongoing discussions with the FDA regarding trial designs and endpoints [11][12] 4. **Jakafi XR**: Expected introduction in mid-2026, with a potential conversion model for sales ranging from 10% to 30% [16] 5. **Monjuvi Performance**: Positive early results with plans for label expansion into earlier treatment lines, with expected results by late 2026 or 2027 [20][23] Financial Outlook - **Revenue and Cash Flow**: Strong revenue, earnings, and cash flow projected over the next several years, with a focus on converting scientific advancements into financial success [3] - **R&D Investment**: R&D resources will be primarily allocated to hematology-oncology and immunology, with ongoing evaluations of project viability [38][39] Competitive Landscape - **Market Position**: Incyte believes it has a competitive edge in the hematology space with its targeted therapies, despite the presence of competitors like Ropeg [22] - **AI Utilization**: Incyte is leveraging AI across various departments to enhance efficiency and regulatory processes [44][46] Additional Considerations - **Dermatology Market**: Opzelura is positioned to grow significantly, with a projected 10% CAGR over five years, driven by a shift away from topical corticosteroids [33][34] - **Regulatory Environment**: The FDA remains a reputable body, with ongoing changes that are viewed as transient rather than permanent challenges [47] Conclusion Incyte is strategically positioned in the oncology and immunology markets with a robust pipeline and a clear focus on targeted therapies. The company is optimistic about its growth potential, driven by innovative products and a strong financial outlook, while also navigating a competitive landscape and regulatory challenges.

Core Insights - Incyte (INCY) has shown strong performance, reaching a 52-week high of $87.24 on August 18, with a subsequent slight dip to $85.46, resulting in a 26.8% increase in stock price compared to the industry’s 6.3% gain [1][8]. Financial Performance - Jakafi sales increased by 15% to $1.5 billion in the first half of 2025, while Opzelura sales surged 37% year over year to $283 million during the same period [5][7][8]. - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen to $6.07 from $5.77 over the past 30 days, with the 2026 EPS estimate increasing by 36 cents to $7.49 [21]. Product Pipeline and Regulatory Updates - The FDA approved a cream formulation of ruxolitinib (Opzelura) for mild to moderate atopic dermatitis and non-segmental vitiligo, marking it as the first topical JAK inhibitor approved in the U.S. [6][8]. - Incyte's oncology portfolio has been bolstered by FDA approvals for Monjuvi and Zynyz, expanding treatment options for various cancers [9][12]. - The collaboration with Qiagen aims to develop a diagnostic panel for myeloproliferative neoplasms, enhancing Incyte's pipeline [13][14]. Competitive Landscape - Incyte's reliance on Jakafi for revenue growth is significant, as it accounts for over 70% of total revenues, and competition is increasing with new entrants like GSK's Ojjaara [15][16][23]. - The patent protection for Jakafi is expected to expire in the coming years, posing a potential risk to future revenue streams [17]. Management and Strategic Direction - Incyte has appointed Bill Meury as the new CEO, indicating a potential shift in strategic direction [23].

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].

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]