Incyte Corporation

Hello, and welcome to the Insight Third Quarter Earnings Conference Call. 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 place into question queue anytime 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.

Thank you, Kevin. Good morning and welcome to Insight's third quarter 2023 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 the discussion related to today's call. On today's call, I'm joined by Herve, Pablo, Barry, Stephen, Christiana, who will deliver our prepared remarks and will participate in the 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. In the third quarter, we continue to deliver double-digit revenue growth, important successes in pricing and reimbursement, and continued progress of the pipeline. Product and royalty revenues were $914 million in the quarter, with an 11% growth year-over-year driven by Jackify and Obsidua. Jackify net sales in the quarter were impacted by inventory variation, which Christiana will detail in her prepared remark. As you see, in the first nine months, Jackify growth continues at a rate of around 8% this year. The growth trajectory of Opselora continued in the third quarter with net product revenue of 92 million, driven by both new patients and refills in ED and vitiligo. In the first nine months of 2023, Opselora revenues contributed 229 million, and we expect Opselora to continue to be a key contributor to the growth of Insight in the next year. On slide six, We made important progress this quarter on two fronts related to pricing and access. First, as the IRA is implemented, we secured small biotech exception status for Roxolite Lib. This has two impacts on Jackify pricing and growth to net in the coming years. One, we expect that Jackify will be exempt from negotiation until 2029, making it de facto neutral to our initial business plan. And two, as you can see, we expect to benefit from the specified small manufacturer phase-in schedule for Part D catastrophic coverage versus the standard benefit, which will have a meaningful impact in the years 2025 to 2031. For Opselora coverage in the U.S., starting in 2024, Opselora will be listed as a preferred brand on the CVS Caremark and Aetna formularies, which will benefit roughly 30 million commercial lives. This achievement will move Obcelora to preferred brand from non-preferred brand tier and will result in increased access by reducing both step-elite requirements. Patients copay for many patients while maintaining Obcelora's favorable utilization management criteria. Turning to slide seven, we continue to make progress in our clinical development efforts across our portfolio. Just last week, we obtained new top-line results from the Phase II randomized study assessing the efficacy and safety of povacitinib, our oral JAK1 inhibitor in patients with prurigo nodularis. The study met its primary endpoint across all three treatment dose groups, and povacitinib was generally well tolerated. There are approximately 100,000 treated patients in the U.S. with prurigo nodularis with limited treatment options, and we are excited to move this program forward based on the Phase II data. Stephen will provide additional details. During the quarter, we had a significant presence at EADV, where we presented the full obcellular atopic dermatitis data in the pediatric population and positive long-term extension data in vitiligo. We also shared new positive data from the Phase IIb clinical trial of povercitinib in adults with extensive vitiligo. By the end of the year, we anticipate providing additional data from other key programs, including an update on our oral PD-L1 program, additional combination data of roxalitinib plus ALK2 and BED, and full disclosure of a novel preclinical program targeting the JAK2V617F mutation, which has the potential to be a disease-modifying therapy for many patients with myeloproliferative neoplasms. I will now turn the call over to Barry, who will discuss our commercial performance in more detail.