Financial Data and Key Metrics Changes - Syndax reported total revenue of $45.9 million for Q3 2025, reflecting a strong 21% growth over the prior quarter [4] - Revyforge net revenue was $32 million in Q3, up 12% from the prior quarter, with a 25% increase in total prescriptions and new patient starts [5][11] - Nictimvo net revenue reached $45.8 million in Q3, marking a 27% increase over the prior quarter [9][19] Business Line Data and Key Metrics Changes - Revyforge has become the standard of care for relapsed refractory KMT2A, with approximately 50% of usage in the second line [5] - Nictimvo is annualizing at nearly $200 million within the first eight months of launch, tracking in line with first-year sales of similar therapies [9] - The approval of Revyforge for relapsed refractory NPM1 mutated AML has expanded the addressable patient population significantly [6][15] Market Data and Key Metrics Changes - The total addressable U.S. population for Revyforge has increased from approximately 2,000 to 6,500 patients with the new indication [15] - Nictimvo is targeting a market opportunity of approximately $2 billion, with 6,500 patients in the U.S. requiring three or more lines of therapy [21] Company Strategy and Development Direction - The company aims to expand Revyforge and Nictimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion [10] - Syndax is focused on executing pivotal trials for menin inhibitors, with Evolve 2 being the first frontline trial to start enrolling patients [10][28] - The company is leveraging its strong commercial foundation and prescriber relationships to drive growth in both product lines [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability, citing strong performance from both Revyforge and Nictimvo [38] - The company anticipates that the average duration of therapy for KMT2A patients will increase to six to twelve months in 2026 as treatment patterns mature [14][44] - Management highlighted the positive feedback from healthcare providers regarding the efficacy and tolerability of both Revyforge and Nictimvo [20][22] Other Important Information - Syndax has a strong financial position with $456 million in cash equivalents and investments as of September 30, 2025 [38] - The company has received three FDA approvals and is positioned for sustained growth with its current product offerings [39] Q&A Session Summary Question: How has Revyforge's place in lines of therapy evolved? - Management noted that about 70% of Revyforge's business is in the second or third line, a shift from clinical trials where patients were typically in third or fourth line [41][42] Question: What factors will help narrow the duration of therapy range for 2026? - Management indicated that the mix of KMT2A and NPM1 patients will influence the duration of therapy, with expectations for longer durations as more patients return from transplant [44][45] Question: What is the maintenance restart rate for patients who started Revyforge during the launch? - The restart rate has increased to about 35%-40%, with expectations for further growth as more patients return from transplant [46][47] Question: How will revenue per prescription evolve with the inclusion of more NPM1 patients? - Management does not expect significant changes in average revenue per prescription as NPM1 patients are integrated into the prescribing base [49] Question: What has been the impact of the NCCN guidelines on the NPM1 launch? - Management reported strong awareness and excitement among healthcare providers, setting a positive trajectory for the NPM1 launch [54][56]

Financial Data and Key Metrics Changes - Total product revenues for Q2 reached $1,060 million, a 17% increase year over year, driven by strong demand for Jakafi and Opsilura, as well as contributions from Nictimvo's launch [20][21] - Total revenues were $1,220 million, up 16% compared to the same period last year [20] - Jakafi net product revenue was $764 million for Q2, representing an 8% growth year over year [20] - Opsilura's net product revenue for Q2 was $164 million, a 35% increase year over year [21] - The company raised its full-year revenue guidance for Jakafi to a range of $3,000 million to $3,050 million [21] Business Line Data and Key Metrics Changes - Opsilura showed strong growth across atopic dermatitis and vitiligo, with nearly 20,000 prescribers and potential for new indications [7][21] - Nictimvo generated $36 million in net product revenues in Q2, with rapid adoption among BMT centers [23] - Other hematology-oncology products saw net revenues of $131 million, a 66% year over year increase, driven by the Nectinvo launch and higher demand for ZYNES [25] Market Data and Key Metrics Changes - U.S. net product revenue for Opsilura was $132 million, up 19% year over year, while ex-U.S. revenues were $32 million, driven by uptake in France, Germany, and recent launches in Italy, Spain, and Canada [22] - Nictimvo achieved approximately 82% account penetration in BMT centers across the U.S. [23] Company Strategy and Development Direction - The company aims to build a comprehensive plan for acceleration, focusing on R&D productivity, operating expenses, and capital allocation [9][17] - Strategic priorities include taking care of core products, accelerating product development, and careful capital allocation [9][14] - The company recognizes the importance of converting scientific advancements into regulatory approvals and business results [9][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for new product flow and emphasized the importance of execution in driving growth [5][18] - The company expects FDA approval for Opsilura in pediatric patients by September and is on track with pivotal trials for povastatinib [18] - Management highlighted the need to manage expenses in a disciplined manner while focusing on growth [17][28] Other Important Information - The company recorded a benefit of $242 million from a contract dispute settlement with Novartis, leading to a reduction in COGS [25] - R&D expenses for Q2 were $495 million, with an increase of 8% year over year, driven by investments in late-stage development assets [26] Q&A Session Summary Question: Importance of therapeutic areas at Incyte - Management indicated that MPNs are the most important therapeutic area, with a significant opportunity to transform treatment in this space [43][44] Question: Read-through from Kallar data for ET and expectations for MF - Management noted that the mechanism of action for the mutant CalR antibody suggests a high probability of success in MF based on ET data [52][53] Question: Initial data for six seventeen F and its delay - The delay was attributed to the need for higher doses and longer follow-up to obtain sufficient data [56][59] Question: Dynamics of Nictimvo's launch and inventory impact - Management reported a 10% penetration in the third-line market and noted that inventory accounted for less than 5% of Q2 sales [70][75] Question: Balancing investment in pipeline advancement and external opportunities - Management emphasized the importance of capital allocation and the need to make informed decisions based on facts and analysis [96][99]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues reached $1,050 million, reflecting a 20% year-over-year increase, while product revenues grew 26% to $922 million [6][15][16] - The cash position at the end of the quarter was $2.4 billion [6] - The company raised its full-year 2025 net product revenue guidance for Jakafi to a range of $2,950 million to $3,000 million [7][23] Business Line Data and Key Metrics Changes - Jakafi's net product revenue increased 24% year-over-year to $709 million, with total patients rising 10% compared to Q1 2024 [7][16] - OPSELURA's total revenue was $119 million, up 38% year-over-year, driven by growth in the U.S. and contributions from Germany and France [8][19] - Nictimvo, launched in January 2025, generated $14 million in net product revenues in its first quarter, with strong early launch metrics [10][11] Market Data and Key Metrics Changes - The U.S. market for OPSELURA saw a significant increase in annual prescription trends, with commercial coverage improving from 86% to 94% due to formulary changes [9] - The company expects minimal impact from potential tariffs on pharmaceuticals due to established dual sourcing strategies [12][13] Company Strategy and Development Direction - The company plans to launch four new products in 2025 and initiate at least three Phase III studies, anticipating significant growth from these developments [11][31] - The focus remains on expanding the commercial portfolio and advancing the R&D pipeline, with a strong emphasis on addressing unmet medical needs [6][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of Nictimvo and the overall growth trajectory driven by successful product launches and ongoing demand for existing products [6][35] - The company highlighted the importance of upcoming milestones and catalysts in 2025, which are expected to shape its growth trajectory [35] Other Important Information - The company is committed to maintaining a strong cash position while investing in R&D and commercial activities [6][15] - Management noted that the exposure to China is limited, with alternative sources of supply available if needed [14] Q&A Session Summary Question: Expectations for Jakafi's growth driven by new patients versus continued use - Management indicated that growth will be driven by both new patient starts and continued therapy adherence, emphasizing the importance of early treatment with Jakafi [38][41] Question: Positioning of Povo for chronic spontaneous urticaria - Management believes Povo will serve both patients who fail antihistamines and those who prefer an oral option before biologics [45][46] Question: Update on Kallar Compound data - Management confirmed that data will be presented in 2025, including a range of doses and clinical endpoints [54][55] Question: Contribution of atopic dermatitis and vitiligo to OPSELURA - Management noted that both indications are growing at a similar pace, with efforts to improve access to atopic dermatitis treatments [64][65] Question: Capital allocation and business development strategy - Management stated that internal pipeline success drives capital allocation, with a focus on R&D and potential early-stage partnerships [68][70]