Incyte Corporation

Greetings, and welcome to the Insight First Quarter 2026 Earnings Conference Call and Webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You may be placed in the question queue at any time by pressing star 1 on your telephone keypad, and we ask that you please limit yourselves to one question and then return to the queue. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star 0. It's now my pleasure to turn the call over to Alexis Smith, Vice President, Head of Investor Relations. Please go ahead, Alexis.

Thank you. Good morning and welcome to Insight's first quarter 2026 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables, and slides that follow today's discussion. On today's call, I am joined by Bill, Pablo, and Tom, who will deliver our prepared remarks. Stephen, Dave, and Mohamed will also be available for the Q&A portion of today's call. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Bill.

Thank you, Alexis, and good morning, everyone. We're off to a strong start in 2026, with net sales up 20% year over year, driven by strong demand across our entire portfolio. In parallel, we advanced the pipeline with key regulatory and clinical milestones. We view 26 as a year of strategic progress as we transition Insight beyond a single cornerstone product toward a high-quality growth-oriented portfolio across hematology, oncology, and immunology. This progress will come from multiple sources, the continued organic growth from our commercial portfolio, the execution of lifecycle launches of key brands, the advancement of a broad, increasingly late-stage pipeline, and a focused approach to business development. The sequencing and pace of execution here matters, as these efforts are intended to lay the foundation for a future beyond Jackify. During the quarter, the FDA accepted our regulatory application for povacitinib in patients with moderate to severe HS. The application was submitted ahead of schedule and is supported by a robust, high-quality data set across both pre- and post-biologic patient populations. If approved, we believe POVO should be a significant growth driver for Insight as the first FDA-approved oral anti-inflammatory treatment for HS, a disease which affects more than 300,000 people in the United States. We also remain on track for several regulatory decisions this year, including Jackify XR, which has the potential to generate meaningful sales and serve as an important sales bridge, and Opsalura for moderate atopic dermatitis in Europe, a key future growth opportunity for the brand and our international business. Finally, we expect global submissions from Anjuvi in the first-line DLVCL in the first half of the year, with approval and launch anticipated in early 2027. Across the pipeline, we continue to advance novel compounds that support our broader transition to a Hemonc I&I company. The pipeline reflects a deliberate balance of risk and reward, combining programs with the potential for outsized returns alongside opportunities that can deliver incremental but highly reliable growth. This work is backed by an experienced clinical development and clinical operations team and consistent execution across trials. In hematology, we had a positive end of phase meeting with the FDA in the first quarter and are on track to initiate our phase three studying evaluating our mutant CalR antibody 989 in previously treated CalR positive patients with ET by mid-year. This represents an important step as we continue to build a portfolio of molecularly targeted therapies, which Pablo will discuss in more detail shortly. In oncology, we now have four pivotal trials underway across colorectal, ovarian, and pancreatic cancers, including the recent initiation of our G12D program in first-line pancreatic cancer earlier this month. These programs target areas of significant unmet need and represent meaningful long-term growth opportunities for the company. In immunology, we are advancing registration programs in mild to moderate HS for Opsilora and moderate to severe HS, Vitiligo, and PN for Povacitinib. In addition to the regulatory acceptance for POVO and HS mentioned earlier, today we announced positive results from both Phase III registration studies in adults with non-segmental Vitiligo. These results will support a regulatory application in non-segmental Vitiligo expected in the first half of 2027. Over time, we believe the INI portfolio at Insight has the potential to become a significant contributor to the business, representing approximately one-third of total revenue by 2030. Finally, I want to take a moment to talk about management. At this stage of the company, our results depend largely on the strength of our management team, experience, judgment, decision-making, and the ability to execute strategic plans. With that context, we have made several executive appointments. This morning, we announced the appointment of Suki Upadhyay as Chief Financial Officer. Suki brings deep experience, leading large finance organizations, most recently Zimmer Biomet and Bristol Myers Squibb. We also announced the appointment of Pablo Cagnoni as President Insight and Global Head of Research and Development, and Stephen Stein as Executive Vice President, Chief Medical Officer, and Head of Late-Stage Development. Additionally, Mohamed Issa was appointed as Executive Vice President, Head of U.S. Commercial coinciding with the integration of our U.S. commercial operations into a single organization. Mohammed is an experienced executive with a track record in new product launch planning and operations. The new structure is intended to establish consistent standards and enterprise-level capabilities across analytics, market access, sales operations, and patient services, creating a launch-ready organization in 2026. These capabilities can be leveraged across the portfolio to maximize the return on our commercial investments. Taken together, these appointments give us the management experience and operational oversight for the next phase of the company. Now turning to the quarter. Total revenue in the first quarter of 26 was $1.27 billion, up 21% over prior year. Net sales in the first quarter totaled $1.1 billion, representing 20% growth year over year. Sales increased for every marketed product, both in the United States and internationally, and was driven by strong prescription and volume demand across the portfolio. Jackify sales in the first quarter were $758 million, up 7% year-over-year. Prescription demand increased 6%, with broad-based growth across all indications, MF, PV, and GVHD. New patient starts remain strong, the prescriber base is stable, and a formulary coverage is broad, providing an important foundation for the Jackify XR launch. We anticipate the approval and launch of XR in the middle of the year. Our immediate focus will be on securing adequate formulary coverage for XR over the next 12 months post-launch. We estimate that XR can achieve 10% to 30% of Jackify's business by 2029. We'll provide more insights on the launch in future quarters. Sales for our core business, excluding Jackify, were up 63% year-over-year, with contributions across hematology, oncology, and immunology. This business will be supported by four new product launches over the next 12 months, including Jackify XR, Opsalur for moderate AD, Dermatitis in Europe, Monjuvi in first-line DLBCL, and Povacitinib in HF. As we've discussed, our core business, X-Jackify, has the potential to approach $3 to $4 billion by 2030, reflecting the strength of the portfolio and continued execution. It is becoming an increasingly important part of how we transition the company for long-term growth. Opsalor continues to be the largest single contributor to the core business, X-Jackify, with sales of $143 million, up 20% versus prior year. In the U.S., sales were $106 million, an increase of 12% versus the first quarter of 25%. The underlying prescription demand for this business is strong, up 17% year-over-year, which is supported by the continued adoption of non-steroidal topical therapies. Internationally, growth remains robust in Vitiligo, where we see strong uptake across markets. In the first quarter, sales totaled $37 million, up 56% year-over-year. Internationally, growth remains robust in Vitiligo, where we see strong uptake across markets. As a reminder, Opsalura is under review by European regulators for moderate AD, and we expect approval and launch in the second half of the year. The moderate AD indication has the potential to contribute meaningfully to top-line revenue beginning later this year. For full year 26, we anticipate that roughly 80% of revenue will come from the U.S. and 20% from international markets. In hematology and oncology, net sales grew 116% to $204 million. Nictimbo, Monjuvi, and Zinus were the largest contributors to growth in the quarter. Nictimbo has now entered its second year following its launch in the first quarter of 25. Net sales were $55 million in the first quarter of 26, reflecting a strong, consistent new patient start profile and solid persistency. We've built a broad growing prescriber base with virtually every BMT center in the United States using Nictimbo with all becoming repeat customers. Within 12 months, Nictimbo has captured 32% of the third line plus market. Finally, formula and payer coverage remains strong for the brand. Monjubi sales were 49 million in the first quarter, up 67% year over year. Growth was primarily positive. driven by uptake in follicular lymphoma following approvals in the U.S. and international markets. Looking ahead, a potential U.S. approval in first-line DLVCL represents an incremental growth opportunity starting in 2027. Finally, Zinus sales were $41 million in the first quarter with rapid and robust adoption in SEAC. Now I'll turn the call over to Pablo.