Kiniksa Pharmaceuticals International, plc

Thank you for standing by and welcome to the Connexa Pharmaceuticals Third Quarter 2025 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 1-1 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 Officer. Please go ahead, sir.

Thank you, Operator. Good morning, everyone, and thank you for joining Conixa's call to discuss our third quarter 2025 financial results and recent portfolio executions. A press release highlighting these results can be found on our website under the Investors section. As to the agenda for today's call, our Chief Executive Officer, Sanj K. Patel, will start with an introduction and overview of our business. From there, Ross Moat, our Chief Corporate and Commercial Officer, will discuss our IL-1 innovation franchise and provide an update on Arclist commercial execution. Then, Connexus Chief Financial Officer, Mark Rogoso, will review our third quarter 2025 financial results. And finally, Sanj will share closing remarks and kick off the Q&A session, for which Dr. John Paolini, our Chief Medical Officer, and Evan Tesari, our Chief Operating 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 these statements. Review of such statements and risk factors can be found on this slide, as well as under the caption, risk factors contained in our SEC filings. These statements speak only at 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 Sonj.

Thanks, Jonathan, and good morning, everyone. Year to date, in 2025, we've continued to execute and meaningfully advance our commercial business and clinical development portfolio. The use of IL-1 alpha and beta inhibition with Arclist has increasingly become the preferred treatment for recurrent pericarditis, driving significant Arclist revenue growth and positioning our franchise for long-term success, both with Arclist and KPL387. We continue to be excited about the potential of our IL-1 inhibition franchise and fully intend to remain the market leader in recurrent perichondritis. Given the fact that, as last reported, we were only 15% penetrated into the multiple recurrence patient population, we expect to continue to grow our CLIS revenue. To this point, as announced this morning, we've raised our full year net sales guidance to between $670 to $675 million from our previous guidance of $625 and $640 million. We also believe KPL387 could be an important advancement in the treatment of options available for patients, potentially increasing penetration and growing the recurrent pericarditis market. We remain on track to report data from the Phase 2 dose focusing portion of the Phase 2, Phase 3 trial in the second half of next year. Additionally, we are pleased to report that early this month, the FDA granted KPL387, orphan drug designation for the treatment of pericarditis, which includes recurrent pericarditis. Importantly, we have maintained a robust financial position while continuing to create value without relying on the capital markets. Turning to the growing adoption of IL-1 alpha and beta inhibition with Arclist, we've introduced and advanced a fundamental shift in the treatment paradigm for this disease. Ross will share more details about this in a moment. In the third quarter, Arclist revenue grew to $180.9 million, which represents a growth of approximately $24 million over the previous quarter and approximately $69 million compared to the third quarter of 2024. While we're pleased with this growth, we continue to believe in the significant opportunity for additional growth ahead. As of the end of the second quarter, we were only 15% penetrated into the multiple recurrence opportunity. And we continue to see ARCLIS utilized earlier in the course of the disease. As previously stated, approximately 20% of Arclist prescriptions have been written for patients following their first recurrence. For patients who failed NSAIDs or colchicine, physicians are more readily turning to targeted IL-1 alpha and beta inhibition with Arclist, rather than risk an unnecessary flare by treating patients again with a previously unsuccessful treatment. Overall, the progress we've made reflects the medical community's growing adoption of IL-1 pathway inhibition and speaks to the future value creation of our IL-1 inhibition franchise. With that, I'll turn it over to Ross. Thank you, Sanj.