Kiniksa Pharmaceuticals International Plc Q4 FY2024 earnings call

• Announced the KPL-387 program, an IL-1 receptor antagonist for recurrent pericarditis with potential monthly Sub-Q dosing. Phase 1 data supports monthly dosing, plan to start Phase 2/Phase 3 trial in mid-2024 with Phase 2 data expected in H2 2026 and goal to have it available by '28/'29.
• 2025 ARCALYST net revenue guidance is between $560 million and $580 million.
• Advancing KPL-1161, an Fc-modified IL-1 receptor antagonist with quarterly Sub-Q dosing, conducting IND enabling activities.
• Discontinuing abiprubart in Sjogren's disease, evaluating strategic alternatives for the asset.
• Strong commercial execution with ARCALYST, continuous revenue growth, and a robust balance sheet with cash flow positive on an annual basis.

The company's main product segment is ARCALYST. In the fourth quarter of 2024, ARCALYST net product revenue was $122.5 million. For the full year 2024, ARCALYST net revenue was $417 million. On the collaboration profit side, ARCALYST collaboration profit grew 125% to $76.3 million in the fourth quarter and 108% to $234.7 million for the full year 2024.

• 2025 ARCALYST net revenue is guided to be between $560 million and $580 million.
• Plan to start a Phase 2/Phase 3 trial in recurrent pericarditis patients with KPL-387 in the middle of 2024, with Phase 2 data expected in the second half of 2026.
• Aim to have KPL-387 available to patients by the '28/'29 timeframe.

• Forward-looking statements made are subject to risks and uncertainties that may cause actual results to differ materially from these statements. Risk factors can be found in SEC filings.

Q: Maybe what does your market research suggest about what a monthly subcutaneous formulation such as KPL-387 could mean for patients in the market overall versus the weekly regimen that you have with ARCALYST Sub-Q.

A: Ross Moat said that the compliance rate and acceptance rate of ARCALYST is good, and moving potentially from a weekly to a monthly therapy could be advantageous for many patients in terms of preference, and along with the drug itself, from a lyophilized powder to a liquid formulation may also provide some advantages for patients.

Q: Just wanted to confirm that that dose F, the red line, that's referring to a monthly subcutaneous dose, not an IV dose.

A: John Paolini confirmed that the dose that was administered and characterized in the red line was indeed subcutaneously administered, and it lasts above the target concentration for the time denoted thus supporting moving forward with a monthly dosing paradigm subcutaneously.

Q: How is KPL-387 differentiated from our police? Is it only the dosing schedule or are you expecting changes in the efficacy and safety profile? And then, a quick follow up. Just do you own the full rights to KPL-387 and 1161?

A: Ross Moat said regarding the mechanism of action of KPL-387, it is mechanistically distinct by binding to the receptor subunit, but in that sense, it does block the signaling of both IL-1α and IL-1β and thus it shares a certain amount of mechanistic similarity from there in terms of how the drug is delivered. Sanj Patel confirmed that Kiniksa owns the full rights to KPL-387 and 1161.

Q: Maybe what does your clinical development plan look like for KPL-387 and just quickly on the Regeneron arrangements?

A: John Paolini said that they have engaged with the FDA regarding the design of the Phase 2/Phase 3 trial for KPL-387 and anticipate starting it in the middle of 2024. Sanj Patel said that Regeneron is a great partner, they are fully committed to ARCALYST and its growth, and they are very excited about KPL-387 as a potential treatment option for patients and will continue to work with Regeneron to get it to market as fast as possible.