Incyte Corporation

Greetings, and welcome to the Insight Fourth Quarter 2024 and Full Year Financial and Corporate Update Conference Hall and Webcast. 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 in the question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Thank you, Kevin. Good morning and welcome to Insight's fourth quarter and full year 2024 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'm joined by Irve, Pablo, Christiana, who will deliver the prepared remarks. Matteo and Steven will also be available for Q&A. I would like to point out that we'll 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 SEC filings for additional detail. I will now hand the call over to Hervé.

Thank you, Ben, and good morning, everyone. So we delivered another strong year with 2024 total revenues growing 15% versus 2023 to reach 4.2 billion, continuing the steady growth we have delivered since 2020. In addition to the consistent performance of JacaFi in 2024, we saw strong growth from our non-JacaFi revenue, primarily driven by Obsedora, highlighting our continuing revenue diversification. Moving to slide six. In 2024, JacaFi net sales were $2.8 billion, growing 8% versus the prior year, with growth coming from all indications. Obcelora saw strong continued momentum in 2024, growing 50% to $508 million, driven by both new patients and refills in A.D. and vitiligo in the U.S., and expanding reimbursement outside the U.S. We expect Obcelora to continue to be a key contributor to growth in the next years. Our cash flow remains strong, which allowed us to complete a $2 billion share repurchase during 2024 while maintaining a strong balance sheet. We ended 2024 with $2.2 billion in cash and no debt. We are in a very strong financial position with growing revenues and a robust pipeline that will deliver a number of very exciting readouts in 2025. Last month, we and our partner, Syndax, announced that the FDA approved Nictinvo in 9 mg and 22 mg vial sizes, paving the way for the commercial launch. This medicine is now available in the U.S., and the commercial launch is underway. Nictinvo is the first anti-CSF1 antibody approved to target the inflammation and fibrosis associated with chronic GVHD. And we are excited to bring this new therapy to the approximately 6,000 patients who are currently treated after second-line therapy in the U.S. In addition to the launch of Nictinvo, the SNDA for roxalitinib cream in pediatric atopic dermatitis was filed with the FDA, and we are on track for potential approval in the second half of 2025. With 2 to 3 million pediatric patients in the U.S. suffering from atopic dermatitis, we see significant opportunity for oxalicinib cream with its compelling efficacy in controlling itch to address an important need for this patient population. We submitted pivotal study results to the FDA for both staphacitamab in follicular lymphoma and retifanlimab in squamous cell anal carcinoma and anticipate approvals for both in the second half of 2025. These product launches are expected to begin contributing to revenue in the near term with the potential to collectively generate $1 billion in incremental revenues by 2029, further diversifying our revenue. We anticipate all four products to be available in 2025, and we will be leveraging our existing commercial infrastructure established for Jakafi, Opselura, Monjubi, and Pemazir to support the launches of these new products or indications. Moving to slide 9, an update of the fourth quarter and full year 2024 commercial performance for JakaFi. In the fourth quarter, JakaFi net product revenue grew 11% year-over-year to $773 million and grew 8% for the full year to $2.8 billion. Total patients increased 10% in Q4 when compared to the same quarter in 2023. Importantly, growth is being seen across all indications, but with particular strength in PV, with this indication now accounting for 35% of the patients on JAKA5. We expect continued growth of JAKA5 in 2025 and expect the full-year net product revenue for 2025 to be in the range of $2.925 to $2.975 billion. Turning to slide 10 and looking at JAKAFI total paid demand by indication during 2022, 2023 and 2024. As you can see, unit growth remains robust. Myelofibrosis showed growth again this quarter, while the most significant growth was seen in polycythemia vera. We expect PV to become the largest contributor for JAKAFI over time, supported by the data from the MAGIC-PV study which underscores the benefit of early intervention with Jaka-Fi and its impact on thrombosis-free survival. Moving to Opsalura on slide 11, Opsalura net product revenue in the fourth quarter was $162 million, up 48% when compared to the same quarter last year, and this was comprised of $138 million in the U.S., driven by growth in AD and DT-Ligo new patients and refills, and $24 million ex-U.S., driven by growth in Germany and France. Total 2024 full-year net revenue grew 50% versus 2023 to reach $508 million. In the U.S., the annual prescription trends for 2022, 2023, and 2024, as shown on the right of slide 11, reflects continued year-over-year growth of Opsalura from both atopic dermatitis and vitiligo. We anticipate continued growth of Obcelera in 2025 and expect the full year net product revenue to be in the range of $630 to $670 million. On slide 12, so 2025 will be a year of defining catalysts that will provide an inflection point for Insight. As you can see highlighted on slide 12, every program has meaningful milestones expected in 2025. This includes four potential launches, collectively providing important near-term revenue potential, where the launch of Nictimvo is already underway, as I just highlighted. Additionally, we plan to initiate at least three phase 3 studies, including our BET inhibitor, Roxcrim in mild to moderate HS, and our CDK2 inhibitor in ovarian cancer. We expect 2025 will be a data-rich year with four pivotal data readouts, including Roxolitinib XR, which Pablo will highlight shortly. More importantly, we expect seven early-stage programs to generate informative data, which we believe have the potential to transform the company. Before I hand the call over to Pablo, I would like to provide a leadership update for our commercial organizations. After a remarkable decade of dedicated service to InSight, Barry Flannelly has decided to retire from his role as Executive Vice President, Head of US Oncology. We are pleased to announce that Mohamed Issa assumed Barry's role in January, and Mohamed has successfully led US commercial teams in oncology, immunology, and neuroscience, most recently at J&J. I will now turn the call over to Pablo.