Incyte Corporation

At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. In the interest of time, we ask that you please limit yourselves to one question, 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 Scherzer, Investor Relations. Please go ahead, Greg.

Thank you, Kevin. Good morning, and welcome to Insight's first quarter 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 Irvay. Pablo, and Christiana, who will deliver our prepared remarks. Mateo, Mohamed, and Steven 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'll now hand the call over to Hervé.

Thank you, Greg, and good morning, everyone. The first quarter of 25 was very important for Insight, not only because of the good performance of the commercial portfolio, but mostly because Q1 25 puts us on a great trajectory for long-term growth with the continuous expansion of Opsedura, the successful launch of Nick Thimble, and the successes of the pivotal studies in HS and proof-of-concept studies in CSU. The financial performance was very strong, with growth above 20% in both product and total revenues. Our cash position at the end of the quarter reached $2.4 billion. On the commercial side, NICTIMVO's successful launch is one of the four planned launches for Insight in 2025 in the U.S. On the R&D front, we report significant progress so far this year with several key data, positive readout, XR bioequivalence for roxalitinib, proof-of-concept data in chronic spontaneous urticaria for POVO, and phase 3 results for roxalitinib crib in prurigo nodularis and povacitinib in HS. In Q1, product revenue grew 26%, with total revenues increasing 20% year-over-year to $1.05 billion. This growth was driven by the ongoing demand for Jackify and Opsiloar and the initial launch of Nictinvo in third-line chronic GVHD. Moving to slide 7 and the first quarter commercial performance for Jackify, Jackify net product revenue in the first quarter grew 24% year-over-year to $709 million, total patients increased 10% when compared to the same quarter in 2024. Due to strong demand and the expected continued growth of JakaFi, we are raising the full year 25 net product revenue guidance to a new range of 2.95 to 3 billion. Turning to slide 8, I'm looking at JakaFi weekly dispenses by indication during 23, 24, and the first quarter of 2025. As you can see, unit growth remains robust across all three indications. Myelofibrosis showed growth again this quarter, while the most significant increase was seen in polycythemia vera. We expect PV to become the largest contributor for JAK-FI over time, supported by the data from the MAGIC-PV study, which underscores the benefit of early intervention with JAK-FI and its impact on thrombosis-free survival. Moving to Obcelura on slide 9, total Obcelura net product revenue in the first quarter were 119 million, up 38% when compared to the same quarter last year, driven by continued growth in the US, increased contribution from Germany and France, and the more recent launches in Italy and Spain. In the US, the annual prescription trends for 2024 and the first quarter of 2025 as shown on the right of slide 9, reflects continued growth of Obcelura for both atopic dermatitis and vitiligo. Effective March 1st, Optum Premium added Obcelura to their preferred formulary, which means Obcelura is now preferred on two out of the three big PBM national formularies. This change has enhanced our commercial coverage from 86 to 94%. On slide 10, and our newest commercial product, Nictimvo. Nictimvo is the seventh product commercialized directly by Insight after Jacafi, Obcelura, Iclusic, Pemezir, Monjuvi, and Zinit. This novel medicine, launched at the end of January for patients with third-line chronic graft-versus-host disease, addresses an important medical need, and it has significant long-term growth potential. After two months of commercialization, Nictimvo net product revenues in the first quarter were $14 million driven by high patient needs and strong commercial execution, along with our partner, SYNDAX. We are seeing positive early launch metrics with widespread product awareness and interest. 95% of top BMC centers have used NICTIMVO, and 70% of all BMC centers have orders. Nictinvo is the first anti-CSF1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD, and we are already seeing the impact it is having for patients, giving us increased optimism for the long-term potential of this product as it is moving to earlier line of treatment. On slide 11, a reminder that 2025 will be a pivotal year for Insight, with numerous defining catalysts set to create a significant inflection point. The launch of Nick Timbo has already shown strong initial success, and we are preparing for three additional launches this year, collectively offering important near-term revenue potential. We plan to initiate at least three Phase 3 studies, and we anticipate that seven early-stage programs will generate informative data. These developments have the potential to transform our company. Finally, before I turn the call to Christiana, I would like to address the topic of tariffs. Seven years ago, we started a strategy to establish dual sourcing for key inside products with the goal of having a backup FDA or EMA-approved facility in case of technical issues. This approach is giving us today flexibility for key products to manufacture in the U.S. for the U.S. market and from Europe for ex-U.S. Therefore, we expect the impact to inside of any potential tariffs on pharmaceuticals to be minimal. Finally, our exposure to China is now limited to some starting material for some of our drugs, and we currently hold inventory of starting material to support our forecasted supply needs over a multi-year period and have alternative sources of supply of starting materials that we could consider moving to if needed. Now I will hand over the call to Christiana for the financial update.