Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA

Kiniksa Pharmaceuticals International — Q2 2025 Earnings Presentation

36 slides from Kiniksa Pharmaceuticals International's earnings presentation, Jul 29, 2025

  1. Slide 1: Corporate Presentation

    Corporate Presentation JULY 2025

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements This presentation (together with any other statements or information that we may make in connection herewith) contains forward-looking statements with respect to Kiniksa Pharmaceuticals International, plc (and its consolidated subsidiaries, collectively, unless context oth

  3. Slide 3: Addressing Unmet Need is at the Heart of What We Do

    Addressing Unmet Need is at the Heart of What We Do Building on our successful foundation by prioritizing development of novel therapies for cardiovascular indications Current operating plan expected to remain cash flow positive on an annual basis Advancing Clinical Maintaining Strong Portfolio Fina

  4. Slide 4: Innovative Portfolio of Commercial and Clinical-Stage Assets

    Innovative Portfolio of Commercial and Clinical-Stage Assets Developing novel therapies for diseases with unmet need, prioritizing cardiovascular indications Program Indication Preclinical Phase 1 Phase 2 Phase 3 Commercial SPECIALTY CARDIOVASCULAR Recurrent Pericarditis ARCALYST® (rilonacept)1-3 IL

  5. Slide 5: ARCALYST

    ARCALYST ® IL-1α AND IL-1β CYTOKINE TRAP DISEASE AREA: Recurrent pericarditis1; painful and debilitating autoinflammatory cardiovascular disease COMPETITION2: First and only FDA-approved therapy for recurrent pericarditis REGULATORY: U.S. Orphan Drug exclusivity for treatment of and reduction in ris

  6. Slide 6: Pericarditis Patient Turnover Creates Steady Opportunity for Treatment

    Pericarditis Patient Turnover Creates Steady Opportunity for Treatment Of the 14,000 target population with multiple recurrences, there is a high turnover of ~50% of patients each year, meaning ongoing opportunities to ensure diagnosis and targeted treatment Approximately 14,000 recurrent pericardit

  7. Slide 7: IL-1α and IL-1β in the Autoinflammatory Cycle of Recurrent Pericarditis

    IL-1α and IL-1β in the Autoinflammatory Cycle of Recurrent Pericarditis In addition to inflammatory cytokines such as IL-6, promotion and progression of the inflammatory process in pericarditis is due to IL-1α and IL-1β CRP, C-reactive protein; DAMPs, damage- associated molecular patterns; IL, inter

  8. Slide 8: Real-World Evidence of ARCALYST Uptake as a Second-Line Therapy

    Real-World Evidence of ARCALYST Uptake as a Second-Line Therapy RESONANCE is an ongoing observational registry in up to 500 patients from 29 US sites, collecting real-world data on RP natural history and disease management over a 6-year intensive-observation period TREATMENT CHOICE OVER TIME IN PATI

  9. Slide 9: Commercial Experience Highlights Successful Targeting Strategy with Further Upside Potential

    Commercial Experience Highlights Successful Targeting Strategy with Further Upside Potential % of Prescriptions by Number of Recurrences1 SIGNIFICANT MARKET POTENTIAL Recurrent Pericarditis Annual Epidemiology: ~40,000 Only ~15% penetration into the 14K target population at the end of Q2 2025 1 ST R

  10. Slide 10: Strong ARCALYST Growth Driven by Robust Commercial Execution

    Strong ARCALYST Growth Driven by Robust Commercial Execution Year-Over-Year Net Revenue Growth Key Revenue Drivers $156.8M Total Prescribers1 >3,475 Repeat Prescribers1 ~940 $103.4M Payer Approval1 (% of Completed Cases) >90% Average Total Duration $54.5M of Therapy1 ~30 months $27.0M Patient Compli

  11. Slide 11: Key Executional Priorities to Drive Greater Patient and Physician Adoption

    Key Executional Priorities to Drive Greater Patient and Physician Adoption Externally: U.S. thought leaders have introduced treatment paradigms for recurrent pericarditis that recommend IL-1 antagonists, such as ARCALYST, be used ahead of corticosteroids1-3 Promote to the full scope of the broad lab

  12. Slide 12: Growth in Total Patients on ARCALYST Therapy

    Growth in Total Patients on ARCALYST Therapy Acceleration in new-to-brand and restart patients offset higher patient stops over time ARCALYST Patient Flow Illustrative Patient Flow Strong steady growth: >3,475 New to Brand Patients unique prescribers; ~27% of which are repeat prescribers Increases o

  13. Slide 13: ARCALYST Enables Effective Treatment Throughout Duration of Disease

    ARCALYST Enables Effective Treatment Throughout Duration of Disease Patients with multiple recurrences often continue suffering from flares for a median of 3 years2 ~30 ~45% Months1 Of Patients Restarted Average Therapy Following Initial Total Discontinuation Duration of Therapy (Within ~8 weeks) 1)

  14. Slide 14: Expanding Breadth and Depth of ARCALYST Prescribing

    Expanding Breadth and Depth of ARCALYST Prescribing Total and Repeat Prescribers of ARCALYST for The Growing Repeat Prescriber Base is Delivering ~50% Recurrent Pericarditis Patients of All New Patient Prescriptions >3,475 ~1,175 2 Patients >2,300 3 Patients ~1,050 ≥4 Patients 2021 2021 2021 2022 20

  15. Slide 15: Pricing, Access, and Distribution Considerations

    Pricing, Access, and Distribution Considerations Pricing Access Distribution • ARCALYST list price of $23,846 per month • Kiniksa’s goal is to maintain rapid and broad • ARCALYST is distributed through a closed access to ARCALYST for patients with Recurrent network of designated specialty pharmacies

  16. Slide 16: 2025 ARCALYST Net Product Sales Guidance

    2025 ARCALYST Net Product Sales Guidance Revenue guidance increased to $625-$640M from $590-$605M based on accelerated growth year-to-date $625-640M Expected Net Product Sales ~$215M+ Year-over-year growth at the midpoint $417.0M $183M+ $233.2M $110M+ $122.5M $84M+ $38.5M1 2021 2022 2023 2024 2025 1

  17. Slide 17: Summary of ARCALYST Profit Share Arrangement with Regeneron

    Summary of ARCALYST Profit Share Arrangement with Regeneron1 ARCALYST Net Sales (CAPS + DIRA + Recurrent Pericarditis)2 Minus 100% of Profit Split Eligible Cost of Goods Sold3 • Kiniksa is responsible for sales and distribution of ARCALYST in all approved Minus 100% of ARCALYST Field Force Expenses

  18. Slide 18: KPL-387

    KPL-387 MONOCLONAL ANTIBODY IL-1 RECEPTOR ANTAGONIST INHIBITING IL-1α AND IL-1β SIGNALING DISEASE AREA: Recurrent pericarditis; painful and debilitating autoinflammatory cardiovascular disease SCIENTIFIC RATIONALE: Inhibition of IL-1α and IL-1β signaling well-established for the treatment for recurr

  19. Slide 19: KPL-387: Independently Developed IL-1 Receptor Antagonist for Recurrent Pericarditis

    KPL-387: Independently Developed IL-1 Receptor Antagonist for the Treatment of Recurrent Pericarditis KPL-387 • Fully human IgG2 monoclonal antibody • Binds to IL-1R1, inhibiting both IL-1α & IL-1β cytokine-mediated signaling • IL-1 pathway inhibition is well-established and well-tolerated • Monthly

  20. Slide 20: KPL-387 Phase 1 SAD/MAD Study

    KPL-387 Phase 1 SAD/MAD Study First-in-human study evaluating safety, tolerability, pharmacokinetics, and immunogenicity Part A: Single Ascending Dose Cohorts (1-11) Part B: Multiple Ascending Dose Cohorts (12-14) SC Administration IV Administration SC Administration 11 1000 mg (6 active/2 placebo)

  21. Slide 21: The Single-Dose PK of KPL-387 Support the Monthly Dose Paradigm

    The Single-Dose PK of KPL-387 Support the Monthly Dose Paradigm Topline data from KPL-387 Phase 1 single ascending dose study KPL-387 Pharmacokinetics (Subcutaneous Administration) in Healthy Volunteers PK = Pharmacokinetics 21

  22. Slide 22: PK-Modeling and Dose Simulations for KPL-387 Phase 2/3 RP Study

    PK-Modeling and Dose Simulations for KPL-387 Phase 2/3 RP Study Target Concentration Pharmacokinetic modeling of KPL-387 at the anticipated therapeutic dose supports the monthly dose paradigm 22

  23. Slide 23: KPL-387 Development Program Builds on Successful RHAPSODY Design

    KPL-387 Development Program Builds on Successful RHAPSODY Design Phase 2/3 recurrent pericarditis clinical trial Population: Primary Efficacy Endpoint • Up to ~80 patients diagnosed with RP • Time to Treatment Response2 presenting at screening with a qualifying Key Secondary Endpoints pericarditis e

  24. Slide 24: Financials Second Quarter 2025

    Financials Second Quarter 2025

  25. Slide 25: Second Quarter 2025 Financial Results

    Second Quarter 2025 Financial Results Income Statement Three Months Ended June 30, Three Months Ended June 30, Collaboration Expenses1 2025 2024 2025 2024 Product Revenue $156.8M $103.4M ARCALYST Net Sales $156.8M $103.4M License and Collaboration Revenue $0.0M $5.2M Profit Split-Eligible Cost of Go

  26. Slide 26: Appendix Out-Licensing Agreements

    Appendix Out-Licensing Agreements

  27. Slide 27: Out-Licensing Agreements

    Out-Licensing Agreements Partnership with Huadong Medicine Gives Kiniksa Opportunity to Expand Footprint into Asia Pacific Region (Excluding Japan) • In February 2022, Kiniksa announced a strategic collaboration with Huadong to develop and commercialize ARCALYST in Greater China and multiple other c

  28. Slide 28: Appendix ARCALYST (rilonacept)

    Appendix ARCALYST (rilonacept)

  29. Slide 29: RHAPSODY Design

    RHAPSODY Design Event-Driven Pivotal Study Long-Term Extension (LTE) (up to 24 months) Median rilonacept treatment duration prior to the LTE (RI+RW) was 9 months (range, 3-14) End of Treatment Primary Efficacy Endpoint 18 months after the most End of Study Loading Dose Randomization Time-to-First-Ad

  30. Slide 30: 96% Reduction in Risk of Pericarditis Recurrence

    96% Reduction in Risk of Pericarditis Recurrence Pivotal Phase 3 RHAPSODY Data ARCALYST reduced the risk of pericarditis recurrence The primary efficacy endpoint was time to first adjudicated pericarditis recurrence in the randomized withdrawal period. The median time to recurrence on ARCALYST could

  31. Slide 31: RHAPSODY Long-Term Extension Data Demonstrated Continued Treatment Response

    RHAPSODY Long-Term Extension Data Demonstrated Rilonacept Treatment Beyond 18 Months Resulted in Continued Treatment Response1 1) Imazio M, Klein AL, et al. Prolonged Rilonacept Treatment in Rhapsody Long-term Extension Provided Persistent Reduction of Pericarditis Recurrence Risk. Poster 2223 (Pres

  32. Slide 32: Randomized Phase 2 Trial of Rilonacept in Cardiac Sarcoidosis

    Randomized Phase 2 Trial of Rilonacept in Cardiac Sarcoidosis Collaborative study agreement with Mayo Clinic and The Johns Hopkins University PROBE-design study to evaluate efficacy and safety of rilonacept over 24 weeks of treatment in participants with cardiac sarcoidosis1 D1/Week 0 Week 12 Week 2

  33. Slide 33: Appendix KPL-387

    © Appendix KPL-387

  34. Slide 34: KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial

    KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial Phase 2: Dose-focusing study DOSE-FOCUSING : TREATMENT PERIOD (WEEKS 0-24) KPL-387 300mg SC q2wk KPL-387 300mg SC q4wk R LONG-TERM EXTENSION Screening 1:1:1:1 (UP TO 24 MONTHS) 2 KPL-387 100mg SC q2wk KPL-387 100mg SC q4wk NSAIDs and/or colchic

  35. Slide 35: KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial

    KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial Phase 3: Pivotal study R Primary Efficacy Endpoint 1:1 Time-to-first-adjudicated Pericarditis Recurrence3 Screening Single-Blind Run-In Period1 Event-Driven, Double-Blind, Placebo-Controlled, Long-Term Extension Period Randomized-Withdrawal Per

  36. Slide 36: Corporate Presentation

    Corporate Presentation JULY 2025

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