Incyte Corporation

Greetings, and welcome to the Insight third quarter financial results conference call 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 into question queue at any time by pressing star one on your telephone keypad, and we ask that you please ask one question and return to the queue. 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 third quarter 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 our prepared remarks. Barry, 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 our SEC filings for additional detail. I will now hand the call over to Hervé.

Thank you, Ben, and good morning, everyone. The short quarter of 2024 was a very positive quarter for Insight, with a good commercial performance, FDA approval of NIC-TIMVO, and progress of our pipeline with several key data readouts for our clinical programs. In Q3, total revenues increased by 24% year-over-year to $1.1 billion, with net product revenues growing 23%. This growth was driven by the ongoing demand growth for JAKAFI and OBSELORA, which I will highlight in the following slides. In August, we, along with our partners in DAX, announced the FDA approval of Nictimvo for patients with chronic graft-versus-rose disease after failure of two prior lines of therapy, making it the first anti-CSF1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD. To facilitate patient dosing and limit product waste, following the FDA's approval of Nictinvo, we have submitted two smaller vial sizes to the FDA for the approval. Following the potential approval of the new vial sizes, we anticipate launching Nictinvo in the U.S. in the first quarter of 2025. Additionally, the positive pivotal Agave 201 trial results were recently published in the New England Journal of Medicine. NIC-TIMVO was also included in the latest NCCA and clinical practice guidelines in oncology for chronic GVHD treatment, both highlighting the significance of this dataset and the transformative potential of NIC-TIMVO. The SNDA for roxalitinib cream in pediatric atopic dermatitis was recently filed with the FDA, and we are on track for a potential approval in the second half of 2025. During the quarter, we also provided important clinical updates at ESMO with encouraging data for our CDK2 inhibitor in ovarian and endometrial cancers, as well as data from the phase 3 trial of retifamlimab in SCSC. At EADV, we presented extensive data on both povercitinib and roxolitinib cream, including multiple late-breaking presentations that showed the potential of this program to enhance treatment options for individuals with immune-mediated dermatologic conditions such as vitiligo, atopic dermatitis, hydradenitis superativa, and prurigo nodularis. Moving to slide 6, an update of the short-quarter commercial performance of JAKAFI. JAKAFI net product revenue was $741 million, up 16% year-over-year. Paid demand increased 10%, driven by patient growth across all indications. Based on the strength in demand seen during the first three quarters of 2024, we are raising our full year 2024 Jackify net revenue guidance to a new range of $2.74 to $2.77 billion. Turning to slide 7, I'm looking at Jackify's total paid demand by indication during the first nine months of 2022, 2023, and 2024. As you can see, unit growth remains robust. Myelofibrosis is stable year-over-year, with some modest growth seen again this quarter, while the most significant growth is seen in polycythemia vera and graft-versus-roast disease. 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 survivors. Moving to Opsedora on slide 8. Total Opsedora net product revenues in the third quarter were $139 million, up 52% when compared to the same quarter last year. In the U.S., the annual prescription trend for 2022 and 2023 and year-to-date 2024, as shown on the right of the slide 8, reflects continued year-over-year growth of Opsedora from both atopic dermatitis and vitiligo. During the third quarter, we continued to progress with the launch of Obsedura in Europe, so 20 million in net sales during the third quarter were driven by France, where Obsedura is now reimbursed and available in retail pharmacies and from Germany. Earlier this month, we also achieved approval for Atopic Dermatitis and Vitiligo in Canada. On slide 9, I want to highlight three products that are expected to begin contributing to revenue in the near term. We anticipate that Nictimvo for third-line chronic GVHD, Tapacitamab for follicular lymphoma, and Retifanlimab for SEAC could collectively generate 800 million or more in incremental revenues by 2029. We anticipate all three products to be available in 2025, and these incremental sales will be leveraging the current commercial infrastructure used for Monjuvi, Pemazir, and Jaka5. As illustrated on slide 10, these three launches anticipated in 2025 will be followed by larger opportunities in 2026 and 2027, including PovertyNib, CDK2, and Tafacitamab in first-line DLBCF. Between 2027 and 2030, we have multiple programs that hold transformative potential with data for each anticipated in 2025. I will now turn the call over to Pablo.