Incyte Corporation

Greetings, and welcome to the Insight fourth quarter and year-end 2025 Financial Results 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 into question queue at any time by pressing star 1 on your telephone keypad, and we ask that you please limit yourselves to one question, 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 your host, Alexa Smith, Vice President, Investor Relations. Please go ahead.

Thank you. Good morning and welcome to Insight's fourth quarter and full year 2025 earnings conference call. Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables, and slides that follow today's discussion. On today's call, I'm joined by Bill, Pablo, and Tom. We'll deliver our prepared remarks. Stephen, Dave, Mateo, 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 four long 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.

Alexis, thank you, and good morning, everyone. I'll cover two topics today. First, I'll give an overview of our performance in 2025. Then I'll turn to our outlook for 2026 and beyond and the steps we're taking with our core business and pipeline to transition insight. As I touched on at JPM, there are several achievements in 2025 that stand out. First, our business exceeded expectations on three levels. Total sales, Jackify sales, and our core business sales, X-Jackify. Second, we fundamentally changed the shape and maturity of our pipeline. We moved multiple assets from early to late stage development. We now have several outlier opportunities for the treatment of MPNs, pancreatic cancer, colorectal cancer, and HS that have the potential to drive revenue, earnings, and cash flow into the next decade. Finally, regulatory applications for Jacify XR, Opsilor for moderate AD, and Povercitinib for HS in Europe were submitted on a timely basis. The point here is we have much greater visibility into the potential growth profile of the company now than we did at the start of 2025. Everything we accomplished this past year commercially, scientifically, and operationally has created the foundation for an inflection point in 26 and beyond. Now I'll speak to our performance in 25 and the outlook for 26. Turning to revenue, the business performed exceptionally well this past year. Revenues in the fourth quarter totaled $1.51 billion. up 28% versus the prior year. For full year 25, revenue totaled $5.14 billion, up 21% year over year. This was driven by strong commercial performance and an increase in milestone and contract revenue. Net sales in the fourth quarter totaled $1.22 billion, representing a 20% increase versus the prior year. For full year 25, net sales were $4.35 billion, also up 20% year over year. exceeding both expectations and our guidance. Growth was broad-based with nearly every product contributing meaningfully. Focusing on our core business, Xjackify, sales totaled $1.26 billion, representing over $400 million in growth and a 53% increase versus 2024. Opsalura, Nictimbo, and Monjuvi were the largest absolute growth contributors. This core business is expected to grow over 30% in 26 and has the potential to grow at a 15 to 20% five-year CAGR and approach $3 to $4 billion by 2030. Now, a few comments about the key products, Jackify, Opsalura, and our hematology and oncology products. Starting with Jackify in slide 9, fourth quarter and full-year sales exceeded expectations. In the fourth quarter, sales were $828 million. an increase of 7% versus prior year. Full year sales totaled $3.093 billion, representing an 11% increase year over year. Jackify remains an integral part of our business, and keeping it healthy is a priority. It continues to serve as a funding source for our pipeline and for future product launches. A few comments on the fundamentals of this business. First, prescriptions increased 11% in the fourth quarter and 9% for the full year 2025, despite a growing base and competition. Second, demand was up across all three indications. PV will be the largest and fastest growing indication in 26. And with a penetration rate of only 30% versus 60 to 7% in frontline MF, it should be a reliable and significant source of growth going forward. And finally, formulary coverage for Jackify remains excellent with near complete coverage across plans. In 26, we expect net sales to be 3.22 to 3.27 billion. Prescriptions are expected to grow at a high single-digit rate, representing mid-single-digit sales growth compared to 2025. In terms of Jackify XR, we expect to receive an approval and launch in the middle of 26. Given this timing, the second half of the year will be mostly about formulary access, and 27 will be focused on conversion. We'll share more about our launch plans and future calls. Now we'll turn to slide 10 for Opsalura. Net sales in the fourth quarter totaled $207 million, an increase of 28%, and full-year net sales were 678, up 33% versus 2024. Growth was driven by increased penetration in the U.S. AD and vitiligo markets, where Opsalura prescriptions climbed 24% and 15% respectively. The pediatric launch for Opsalura AD is off to a strong start in the United States, with sales already annualizing around $30 million. Both dermatologists and parents are increasingly seeking non-steroidal options for atopic dermatitis, driven by concerns about long-term steroid use. International sales for Opsalura and Vitiligo doubled to $130 million in 2025. In 26, we expect sales of $750 to $790 million, representing roughly a 15% increase at the midpoint. This estimate is based primarily on continued double-digit volume growth in the United States for AD and Vitiligo, partially offset by price actions to expand formulary coverage. as well as sustained double-digit growth internationally off of a larger base as we lap the strong full-year launch for Vitiligo in Europe. Most of the benefits of the moderate AD launch in Europe in the second half of this year are expected in 27 and beyond. As I've said, our aim long-term is to nearly double the size of this business. The non-steroidal segment of the AD market is growing 20% year-over-year, creating a significant tailwind as prescribing migrates from topical steroids to non-steroidal options. We still have a modest share of each of those segments, so there is substantial headroom for growth. In addition to this, our international business and new indications will serve as meaningful catalysts for the next phase of expansion. And now on slide 11, we'll turn to our hematology and oncology products. Net product sales in the fourth quarter were $187 million, up 121% compared to prior year. Full year 25 sales were $583 million, representing an 83% increase compared to 2024, driven by Nictimbo, Monjuvi, and Zinus. Nictimbo finished its first year at $152 million. We achieved broad penetration, deep utilization of BMT centers, and we've reached more than 1,400 patients with 13,000 infusions. In line with expectations, Victimbo is being used widely in the fourth line setting with increasing preference in the third line. As it relates to Monjubi, sales were up 20% versus prior year based on a strong launch in follicular lymphoma in the middle of 2025. As you know, we released data in January in frontline DLBCL where Monjubi plus lenalidomide showed a 25% improvement in PFS, improving on RCHOP chemotherapy. which is a regimen that still accounts for 50% of the first line DLVCL market. This year, we plan to present the data at an upcoming medical meeting, work to incorporate Monjuvi into appropriate guidelines and submit an SBA in the first half with a potential FDA approval by early 27. Looking ahead, we've set our full year guidance for the hematology and oncology business at 800 to $880 million for the year. representing approximately a 40 to 50% increase compared to our performance in 25. Now three takeaways about 26 that I'd like to reinforce before turning over the call to Pablo. First, our core business excluding Jackify has the potential to be as large as Jackify is today by 2030. A key part of that growth will come from product launches we expect late this year and early 27. I mentioned XR. Opsalor and Monjuvi earlier, so I want to make a few comments about where we are with povacitinib. The NDA for povacitinib in HS has been submitted, and we anticipate filing acceptance this quarter. As you know, HS is the first of potentially three indications, the others being PN and vitiligo. POVA has the potential to be the first FDA-approved oral treatment for HS. Here we have an opportunity to capture patients at two critical inflection points, First, in the prebiologic setting, a population with no FDA-approved treatments today, these patients are cycling through antibiotics and steroids that don't address the underlying disease biology. Second, in the postbiologic setting, where IL-17s and TNFs are used but where partial responses are common. An effective oral option could be transformative in both treatment settings. We'll talk more about launch plans in future calls. Second, our pipeline has the breadth and depth to support top tier growth and the potential to 2 to 3x our top line over time. In 26 alone, we will have 14 pivotal trials underway across seven assets by end of the year and multiple data catalysts. Pablo will walk through the status of our key programs and the potential to double our business over time. And finally, we view BD as a multiplier, a way to extend and strengthen the core. We have the capacity to pursue a broad range of opportunities. Ultimately, the size and nature of any deal will be dictated by strategic fit and the potential for durable revenue earnings and cash flow. Now I'll hand it over to Pablo.