Incyte Corporation

If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation and you may be placed into question queue at any time by pressing star one on your telephone keypad. We ask you please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Greg Furtzer, Senior Director of Investor Relations. Please go ahead.

Thank you, Kevin. Good morning and welcome to Insight's second quarter 2025 earnings conference call. Before we begin, I'd 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 am joined by Bill, Christiana, and Pablo, who will deliver our prepared remarks. Mateo, Mohammed, and Stephen will also be available for the Q&A. 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.

Thanks, Greg, and good morning, everyone. Before I get started, and on behalf of the Insight management team and the employees, I'd like to thank and recognize Hervé Openo for his leadership and commitment to Insight over 10 years. His contributions to this company were invaluable and greatly appreciated, and we wish him the best in his retirement. As you know, I started at Insight very recently, roughly 30 days ago, and so before jumping into the quarterly results, I'd like to touch on two fundamental questions I've been asked since joining Insight. The first one is, what specifically attracted me to the company? And second, what are my initial thoughts on strategic priorities? In response to the first question, I naturally studied the company and the business in great detail and spoke to many different stakeholders, including physicians, patients, and investors before joining. And my initial impression is that Insight has all the intrinsic characteristics of a high-quality growth business. That is the potential for new, meaningful product flow, attractive markets, R&D and commercial capabilities, and a strong balance sheet. I believe there's a foundation in place and a path to value creation, but time is of the essence. The non-trivial challenge Insight faces is navigating the company through 2029 and transitioning to a new set of durable product growth drivers. On the potential for meaningful new product flow, Insight has several important product launches between now and 2030. These products, of course, will vary in size. Some will contribute substantially and others incrementally to growth. But either way, there is substrate here. Marketed products, Opsalora, Nectimvo, Monjuvi, and pipeline compounds like 989, our mutant Cal-R monoclonal antibody, and Pobacitinib, our JAK-1 specific inhibitor, have the potential to drive future sales growth and form the company's core. More work remains, of course, but we've made progress with these compounds scientifically and commercially. Opsalora is showing strong broad-based growth today across AD and vitiligo, has close to 20,000 prescribers, and has the potential for new indications in the coming years. Nectimvo is off to a very strong start. Phase 1 results with 989 and ET are promising, and we will share data on MF at the end of the year. And finally, Pobacitinib could support at least three different indications. Next, InSight operates in two of the most structurally attractive markets in the industry, hematology, oncology, and immunology. They're built on solid foundations of science, need, and opportunity, and we have differentiated knowledge and capabilities in these areas, and we'll focus on them. And finally, InSight has well-developed high-quality R&D and commercial capabilities. Yes, there have been R&D setbacks, and we need to convert science into regulatory approvals and business results, but I believe our discovery and development capabilities in our core areas are a competitive advantage. Now, regarding our strategic priorities, here's my initial thinking, and I will come back to you in the coming months with more specifics on the direction we plan to take the company strategically, operationally, and financially. We intend to build a comprehensive plan for acceleration that goes beyond just filling a revenue gap. We'll take a fresh look at this business, including our R&D productivity, operating expenses and capital allocation, and dedicate resources to accelerating product flow and growth. My framework for the business will likely have the following set of priorities. First, take care of the core. That's straightforward. Driving utilization of our major products in the short term is necessary for long-term success. Second, accelerate product development. Pablo and I have spent many hours on this topic. It's almost all we talk about. Our mid- to late-stage pipeline has the potential to unlock the next phase of growth for InSight, but there are still unanswered questions, which is not uncommon. 989 is arguably the most scientifically promising asset in the MPN space as a targeted mutation-specific approach. Our success will depend on translating early Phase I data into a regulatory approval and a marketed product. The medical need and the market potential for 989 is significant. If we're successful, 989 should trigger a fundamental shift in the treatment of MPNs like we've seen in other cancers. For Povacitinib, we have a clear and credible path to turning this into a major product for InSight. Its success will be predicated on execution in areas where Povacitinib can have differentiation such as HS, PN, and vitiligo. In HS, Povacitinib could be the first oral option, which is perhaps the most challenging disease in dermatology. It's not like -3-mediated psoriasis or -13-mediated AD. It's more complex, involves more pathways, treatment success is variable, and so a new treatment option like Povacitinib should be very marketable. As it relates to our early stage pipeline, the scientific rationale behind CDK2, G12D, TGF-Beta, BiPD-1 for select solid tumors, among others, is strong. But as you know, early stage projects inherently involve uncertainties. We will be continuously assessing these and other programs. They'll be put through a framework to be scored and compared to other programs based on strategic importance, PTRS, commercial potential, and return on investment. And I recognize that every use of capital, R&D capital, is an opportunity cost for other uses. Third, capital allocation. We're generating significant cash flow and have a growing balance sheet. The first call on capital will be the core business, our marketed products. The second is the late stage pipeline, and the third is business development. Sometimes our best investments will be inside the company, and other times the reverse will be true. We'll have a governance mechanism for allocating capital internally and externally to ensure long-term growth and maximize shareholder value. Regarding business development, we'll look hard at finding de-risked, pre-revenue, or revenue stage opportunities. As you know, there are very few positive asymmetrical opportunities out there, and it's easy to mistakenly turn a dollar into 50 cents. We'll be careful about where and how much capital we put to work. But when strategically sourced, appropriately priced, and well executed, BD can create a lot of value. We will have a well-defined framework for BD, and we will look for opportunities that fit that framework. Finally, it's important to keep a close eye on execution. Converting science and strategic plans to results is the job. We'll run the business at a detailed level, enhance the quality and speed of decision making inside the company and manage our expenses in a disciplined way, which means focusing on doing more with less versus more with more. I look forward to sharing more details on our strategic framework later this year. Now, moving to our second quarter results, which Christiana will review next, Jackify demand remains very strong across three indications. Opsalora growth was exceptional across two indications, and the NICTimvo launch is exceeding expectations with rapid adoption among BMT centers, reinforcing its commercial potential. The growth prospects for these products are excellent if we continue to execute. On the R&D front, we made excellent progress. We released phase one data on 989 and MF at the end of the year to supplement the data we presented at EHA and NET. We expect an FDA approval for Opsalora and pediatric patients 2 to 11 years of age with mild to moderate AD in September. Importantly, the pivotal trials for Povacitinib and Vitiligo and PN and combination trials with Axotillumab and GVHD are enrolling on track. With that, I'd like to turn the call over to Christiana, who will provide the second quarter commercial and financial update.