Financial Data and Key Metrics Changes - The company has a strong financial profile with significant cash flow and a growing balance sheet, indicating a robust near to medium-term outlook [5] Business Line Data and Key Metrics Changes - The company is focusing on the development of targeted therapies in the oncology and immunology sectors, particularly in myeloproliferative neoplasms (MPNs) and immune-mediated skin conditions [5][12] - The company plans to launch Jakafi XR in 2026, which is expected to preserve some revenue from Jakafi during the transition period [10][11] Market Data and Key Metrics Changes - The estimated market for essential thrombocythemia (ET) is approximately $5 billion, with a significant portion of that market being relevant for targeted therapies like 989 [21] - The total addressable market (TAM) for therapies targeting MPNs is projected to be around $7.5 billion, with potential penetration rates varying between 2% and 5.5% [45] Company Strategy and Development Direction - The company aims to establish a new standard of care for MPNs through the development of targeted therapies, with a focus on five different therapies currently under development [12][13] - The company is also exploring expansion opportunities in the immunology sector, particularly with Opsilura and Povo, which are expected to grow significantly in the coming years [52][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for product flow and the ability to build the company over the next decade, emphasizing the depth of scientific expertise within the organization [5][6] - The management team is optimistic about the upcoming data releases and the potential for pivotal trials in ET and myelofibrosis [16][20] Other Important Information - The company is actively engaging with regulatory bodies like the FDA to discuss pivotal trial designs and endpoints for their therapies [26][28] - The company has a backup plan for its 617F program, ensuring that it remains committed to addressing the needs of patients with MPNs [51] Q&A Session Summary Question: What is the opportunity in essential thrombocythemia (ET)? - Management highlighted that while ET is considered indolent, it is not benign, and there is a significant market opportunity for targeted therapies, particularly for high-risk patients [21][23] Question: What are the plans for pivotal trial design in ET? - The company is considering a straightforward design for pivotal trials in ET, focusing on complete hematologic response and potentially incorporating novel endpoints [25][26] Question: How does the company view the safety of combination therapies? - Management expressed confidence that the combination of their therapies with Jakafi would not present significant safety liabilities, based on preclinical data [42][43] Question: What is the growth potential for Opsilura and Povo? - The company anticipates double-digit growth for Opsilura and sees significant potential for Povo in the HS market, with plans for NDA submission in early 2026 [52][54] Question: What is the strategy for business development? - The company is focused on hematology, oncology, and immunology, with a clear strategy to build a portfolio rather than pursuing isolated assets [61][64]

Financial Data and Key Metrics Changes - The company experienced a 50% increase in revenues from selling goods compared to the same period last year [3] - Revenues from selling goods were $15.4 million for Q2 2025, an increase of $2.1 million or 16% compared to $13.3 million for Q2 2024 [12] - Net income for Q2 2025 was approximately $164,000 or $0 per share, compared to a net loss of approximately $2.2 million or $0.03 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by sales of Elfabrio to Chiesi, with an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil and $1.2 million in sales to Pfizer [12] - Research and development expenses increased by $3 million or 100% to approximately $6 million in Q2 2025, primarily due to preparations for the planned Phase II clinical trial of PRX-115 [14] Market Data and Key Metrics Changes - The global market for Fabry disease is approximately $2.3 billion in 2025 and is forecasted to reach approximately $3.2 billion by 2030 [4] - The company anticipates El Fabryo royalties exceeding $100 million by 2030 based on a projected 15% to 20% market share of the estimated $3.2 billion Fabry total market [6] Company Strategy and Development Direction - The company is focused on building its product development pipeline, particularly in early-stage development assets and therapeutic areas related to renal rare diseases [8] - The company plans to initiate a Phase II study for PRX-115 in 2025 and enroll the first patient in Q4 2025 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic plan and the foundation being built for future growth, emphasizing the excitement around the Phase II program for PRX-115 [18] - The management noted that Chiesi has been performing better than expected in the marketplace, with significant growth in patient acquisition [28] Other Important Information - The company had $33.4 million in cash and cash equivalents and short-term bank deposits as of June 30, 2025 [16] - Eyal Rubens, the Chief Financial Officer, is stepping down after six years, and Gilad Mambloc will succeed him [9][10] Q&A Session Summary Question: Comments on Chiesi's planned study called Pagasso - Management confirmed it is part of Chiesi's phase four program to enhance the merits and strengths of the program [22][23] Question: Details on the Phase II trial for PRX-115 - The company plans to operate between 20 to 30 sites for the trial, primarily in the U.S. [24][25] Question: Market share held by Chiesi in Fabry disease - Management stated they do not disclose specific market share numbers but assured that Chiesi is performing well and growing its market share [27][28] Question: Utilization of Gilad's experience in business development - Management clarified that while Gilad has significant experience, the company is currently not planning any mergers or acquisitions and is focusing on growing its pipeline [30][32]

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]