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]

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]