Incyte FY Conference Summary Company Overview - **Company**: Incyte (NasdaqGS: INCY) - **Date of Conference**: November 10, 2025 Key Industry Insights Hematology and Oncology Focus - Incyte is primarily identified as a hematology company, focusing on myeloproliferative neoplasms (MPNs) with three targeted therapies in mid to late stages of development [4][5] - The company aims to transition from nonspecific symptomatic therapies to mutation-specific targeted therapies, which is expected to be a significant growth driver [4][5] R&D Capabilities - Incyte's R&D organization is described as high-quality and efficient, with a focus on fewer, higher-quality investments rather than diffuse spending [5][6] - The company plans to streamline costs while ensuring critical initiatives are funded adequately [5][6] Pipeline Opportunities Jakafi and Antibody Product Candidate 989 - Jakafi remains a leading JAK inhibitor, but the antibody product candidate 989 is positioned as a potential superior alternative for essential thrombocythemia (ET) and myelofibrosis (MF) [9][10] - The commercial opportunity for 989 in ET is estimated at $5 billion, while in MF, it is projected at $2.5 billion, with expectations of capturing significant market shares [11][12] Clinical Data and Future Trials - Phase one data for 989 shows promise in normalizing platelet counts and improving symptoms in ET and MF patients [13][14] - A phase three program for 989 is expected to start in mid-2026, with more data to be presented at the upcoming ASH meeting [10][11][14] Collaboration and Development Strategy - Incyte has partnered with Enable Injections to develop a subcutaneous formulation of 989, aiming to enhance patient convenience and adherence [21][23] - The acquisition of a JAK2 selective inhibitor is part of a broader strategy to provide comprehensive treatment options for MPNs [26][28] Inflammatory Portfolio Povorcitinib - Povorcitinib is being developed for immune-mediated skin conditions, with a focus on hidradenitis suppurativa (HS) [29][30] - The drug shows rapid pain relief and significant skin clearance rates, with potential to capture a substantial market share [31][33] Commercial Synergies - Incyte aims to leverage existing infrastructure from its Opzelura product to create commercial synergies with Povorcitinib, enhancing operational efficiency and market reach [34] Financial Performance and Growth Projections Opzelura - Opzelura has shown strong growth, with a reported 30% increase in revenue compared to the previous year, and is projected to reach peak sales of $1.5 billion in atopic dermatitis (AD) alone [36][37] Nectimbo - Nectimbo is off to a strong start in the GVHD market, with annualized sales expected to approach $200 million by year-end [40] - The product is primarily used in third-line therapy, with ongoing studies to demonstrate its utility in combination with Jakafi [41][43] Conclusion - Incyte is strategically positioned in the hematology and oncology sectors, with a robust pipeline and a focus on targeted therapies. The company is actively pursuing collaborations and acquisitions to enhance its product offerings and market presence, while also demonstrating strong financial growth across its portfolio.

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 [4][29] - GAAP R&D expenses were $507 million, with a 7% year-over-year increase, driven by investments in late-stage development assets [29] - GAAP SG&A expenses were $329 million, increasing 6% year-over-year, primarily due to international marketing activities [29] - The company raised its full-year net product revenue guidance to $4.23-$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 [5] - Opzelura sales were $188 million, a 35% increase year-over-year, with $144 million from the U.S., representing a 21% increase [6] - Niktimvo sales totaled $46 million, a 27% increase from the previous quarter, with 90% of U.S. bone marrow transplant centers adopting the product [7][8] - Monjuvi and ZYNYZ also saw strong growth, contributing to the raised guidance [9] Market Data and Key Metrics Changes - International sales for Opzelura and vitiligo totaled $44 million, a 117% increase from last year [7] - The market for branded non-steroidal topicals is expanding at a 20% rate, with Opzelura well-positioned to capitalize on this trend [6] Company Strategy and Development Direction - The company is focusing on optimizing promotional strategies and investments for key products to drive future growth [4] - A thorough review of the pipeline is being conducted to prioritize high-value programs, with several preclinical and early clinical stage programs being paused or stopped [17][18] - The company plans to launch three important new products next year: Ruxolitinib XR, Opzelura AD in Europe, and Povorcitinib in HS [9][10] 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 [4][35] - The company is committed to balancing cost management with strategic investments to support long-term growth [14][68] - Management highlighted the potential for significant market opportunities in HS and MPNs, with a focus on targeted therapies [10][12] 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 ongoing developments in PN and vitiligo are expected to further strengthen the company's dermatology portfolio [11] 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 phase two program will likely be released at a future conference [38][39] Question: Sustainability of Naktinvo's growth trajectory - Management indicated strong initial adoption and positive feedback from transplant centers, with a solid growth trajectory expected [72][74] Question: Development path for mCALR - The goal is to start pivotal trials for mCALR in 2026, with a focus on building a pipeline of targeted therapies for MPNs [51][52] Question: Operating expenses and margin profile evolution - Management expects to streamline costs while ensuring critical initiatives are funded, with an anticipated improvement in margins over time [68][69]

Group 1 - Incyte announced new 24-week Phase 3 data from the STOP-HS clinical trial program for Povorcitinib in Hidradenitis Suppurativa at EADV 2025 [1]

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]