Kiniksa Pharmaceuticals International, plc

Thank you for standing by and welcome to the Canixa Pharmaceuticals third quarter 2026 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Jonathan Kirshenbaum, Investor Relations. Please go ahead, sir.

Thank you, operator. Good morning, everyone, and welcome to the Connexa Pharmaceuticals third quarter 2026 earnings call. A press release highlighting our financial results and recent portfolio execution can be found on our website under the Investors section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. From there, Ross Moat, our Chief Operating Officer, will provide an update on ARCOS commercial execution. After that, Mark Ragosa, our Chief Financial Officer, will review our third quarter 2026 financial results. And finally, Sanj will return at the end of the call to share closing remarks and kick off the Q&A session, for which John Paolini, Connexus Chief Medical Officer, will also be on the line. Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from such statements. A review of these statements and risk factors can be found on this slide. as well as under the caption risk factors contained in our SEC files. These statements speak only as of the date of this presentation and we undertake no obligation to update such statements except as required by law. With that, I'll turn it over to Sanj.

Thanks, Jonathan, and good morning or good afternoon, everyone. Over the last 10, 11 years, we've built this company through multiple stages of growth and today, I'm as excited as ever about what the team and I can accomplish together in the years ahead. ConiXa continues to build a leading IO1 alpha and beta inhibition franchise, driven by the commercialization of Arclis in recurrent pericarditis, as well as our progress with KPL387 and KPL1161. This morning, we announced via a press release that we've raised our full year revenue guidance to between $1.045 and $1.050 billion. We continue to see robust growth with Arculus in recurrent pericarditis, driven by strong execution and strategic investments across the business. On the clinical side, we're excited about the progress of KPL387 and KPL1161. The pivotal phase three study with KPL387 continues to enroll and dose patients. We announced today that we expect data from this trial in the second half of 2027. The team and I are really looking forward to potentially launching this drug in the 28-29 timeframe. In addition to providing an important treatment option for patients with recurrent peripatitis, We believe KPL-387 could help grow the market by enabling a once-monthly sub-Q dosing. We're also on track to have KPL-1161, our quarterly IL-1 alpha and beta inhibitor, in a phase one clinical trial by the end of this year. Impulsively, Knix's robust financial profile allows us to continue to invest in penetrating the recurrent pericarditis market and growing the IL-1 Alpha and Beef Innovation franchise while also pursuing additional value creating opportunities. In the third quarter, we saw a continuation of strong Arcus momentum with Q-through revenue of $286 million. The penetration rate into the annual population of 14,000 multiple recurrence patients increased to 23% as of the end of Q3. As shown by the increased breadth and depth of prescribing over time, adoption of IL-1 alpha and beta inhibition continues to expand among the approximately 40,000 recurrent pericarditis patients each year. The underlying fundamentals that propelled our commercial success remain strong. Since launch, we've observed robust payer approval, strong patient compliance, and greater appreciation of the need to treat throughout the multi-year duration of the disease. Underpinning this growth is strong execution by our commercial organization and data-driven investments in our quest. Our AI-supported patient identification initiatives and targeted direct-to-consumer campaign, Pass Home, have positively contributed to growing patient and physician awareness of recurrent pericarditis and the important role of IL-1 alpha and beta inhibition in controlling this debilitating disease. As you've heard, we now expect Arclas to achieve over $1 billion in revenue in 2026. And we look forward to continuing to bring this blockbuster drug to more patients suffering from this debilitating disease. In order to grow the recurrent pericarditis market over the next several years, we plan to drive greater adoption in both the 14,000 multiple recurrence patients annually and the additional 26,000 patients annually that are experiencing their first recurrence. Connexa is executing against its strategy to help more patients drive more alkalis growth and advance KPL 387 and KPL 1161. This trajectory will help put the company on a path to having multiple commercial products, continued strong and profitable growth, and the flexibility to invest in future value creation. I can tell you that the team and I won't rest until we've helped many, many more patients. And now, our President and COO, Ross Moat.