Kiniksa Pharmaceuticals International, plc

Good day, and thank you for standing by. Welcome to Conninsuff Pharmaceuticals' fourth quarter, 2024 earnings conference call. At this time, all participants in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Also, please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, Jonathan Kirschenbaum, Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining ConiXA's call to discuss our fourth quarter and full year 2024 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors section. For the agenda today, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. Dr. John Paolini, our Chief Medical Officer, will review our recently announced KPL 387 development program. From there, Ross Mote, our Chief Commercial Officer, will provide an update on our ongoing commercial execution with Arculus. Then, Mark Ragosa, our Chief Financial Officer, will review our fourth quarter and full year 2024 financial results. And finally, Sanj will return for closing remarks and to kick off the Q&A session, for which Eben 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. A 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 as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law. With that, I will turn it over to Sanj.

Thanks, Jonathan, and good morning, everyone. Thank you for joining our fourth quarter and full year 2024 earnings call. as you know we reported our preliminary oculus revenue and cash balance earlier this year strong execution drove continued growth in 2024 and we're incredibly excited about the opportunities ahead of us today i'm going to focus on the exciting program announcement we made earlier this morning we are advancing our newly announced kpl 387 program which is an independently developed monoclonal antibody IL-1 receptor antagonists with the potential to enable monthly sub-Q dosing in recurrent pericarditis. We are incredibly excited about this program and the opportunity to extend our leadership of the recurrent pericarditis market and to potentially expand the treatment options available to patients. KPL-387 is an IL-1 pathway inhibitor. which we understand very well from our work and experience with Arclist, the first and only FDA-approved therapy for recurrent pericarditis. Dr. John Paolini, our chief medical officer, will share additional details about the mechanism of action and data we've generated to date. But our deep familiarity with this pathway provides us with added confidence as we advance KPL387 through clinical development. In addition to the ongoing Phase 1 study, we've interacted with the FDA and plan to start a Phase 2 slash Phase 3 trial in recurrent pericarditis patients in the middle of this year, with data from the Phase 2 portion expected in the second half of 2026. We plan to move as fast as humanly possible, and our goal is to have this treatment option available to patients by the 28-29 time frame. Moving to our Q4 and full year 2024 performance and future growth. On the commercial front, we continue to grow Arculus revenue and collaboration profitability with fourth quarter net product revenue of $122.5 million and full year 2024 net revenue of $417 million. Ross will review the commercial highlights in a moment, But overall, we believe there is substantial opportunity for us to continue to grow the recurrent pericarditis market with Arclist in the years ahead. Our full year 2025 Arclist net revenue guidance is between $560 and $580 million. As you can see on our pipeline slide, we remain focused on developing novel therapies for diseases with unmet need, prioritizing cardiovascular indications. In addition to KPL387, we're advancing KPL1161, which is an FC-modified IL-1 receptor antagonist with a target profile of quarterly sub-Q dosing. We are currently conducting IND-enabling activities with this molecule. Based on these opportunities, we plan to discontinue development of abiprobar in Sjogren's disease. Through phase two studies, abiprobar has been well tolerated, and we look forward to evaluating strategic alternatives for this asset. I want to extend our sincere gratitude to the patients, caregivers, and investigators who contributed to our Sjogren's disease study. Moving forward, In addition to prioritizing our portfolio development strategy, we have a robust balance sheet, and we are cash flow positive on an annual basis. Together, we expect these to provide additional capacity to continue investing in value-creating opportunities across our business. The bottom line is that we've made tremendous progress with Arculus, and we think there is substantial opportunity still ahead with that first product. As the market leader, we are committed to exploring additional treatment options for patients. And with that, I'll turn it over to John to review KPL387 and our development program in recurrent pericarditis.