Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — Q2 2026 Earnings Presentation
46 slides from Kiniksa Pharmaceuticals International's earnings presentation, Jul 28, 2026
Slide 1: Corporate Presentation
Corporate Presentation JULY 2026
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
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 Advancing Clinical Maintaining Strong Portfolio Financial Position Established leadership in recurrent Positive KPL-387 Phase 2 data
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
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
Slide 6: Pericarditis Patient Turnover Creates Steady Opportunity for Treatment
Pericarditis Patient Turnover Creates Steady Opportunity for Treatment Of the 14,000 annual patients 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 pericarditis
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
Slide 8: ARCALYST is Evolving the Treatment Landscape for Recurrent Pericarditis
ARCALYST is Evolving the Treatment Landscape for Recurrent Pericarditis In the three years following approval, ARCALYST increasingly replaced corticosteroids after NSAIDs and colchicine RESONANCE RWE: Expert Centers in U.S. ACC Concise Clinical Guidance: First U.S. Formal Guidance Second-Line use in
Slide 9: Driving Penetration in Initial Target Population with Upside Opportunity
Driving Penetration in Initial Target Population with Upside Opportunity ARCALYST Label Covers Recurrent Pericarditis (Annual Epidemiology of Approximately 40,000) Increasing Penetration into Multiple Recurrence 1st Recurrence Population ~26,000 21% A sizable portion could be Additional ~20% of pati
Slide 10: Strong Commercial Fundamentals Support Continued ARCALYST Growth
Strong Commercial Fundamentals Support Continued ARCALYST Growth $243.6M >5,0001 Q2 2026 Net Revenue Total Prescribers Representing ~55% YoY Growth ~1,470 Repeat Prescribers ~3 Years1 ~21% 2 Average Total Duration of Therapy In Line with Median Penetration into Multiple Recurrence Duration of Diseas
Slide 11: Key Executional Priorities to Drive Greater Patient and Physician Adoption
Key Executional Priorities to Drive Greater Patient and Physician Adoption Drive physician awareness of the 2025 ACC Concise Clinical Guidance Advance direct-to-patient digital marketing Leverage AI and machine learning to efficiently target potential prescribers Support creation of an efficient net
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: >5,000 New to Brand Patients unique prescribers; ~29% of which are repeat prescribers Increases o
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 years1 Average Total Duration of Therapy Natural History of Patients with Multiple Recurrences ⅓ of Patients with Multiple Recurrences Suffer
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 2 Patients >5,000 ~1,525 >3,475 3 Patients ~1,175 ≥4 Patients >2,300 Q2 2021 Q2 2022
Slide 15: Pricing, Access, and Distribution Considerations
Pricing, Access, and Distribution Considerations Pricing Access Distribution • ARCALYST list price of $25,158 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
Slide 16: 2026 ARCALYST Net Product Sales Guidance
2026 ARCALYST Net Product Sales Guidance Revenue guidance raised to $980-$995M from $930-$945M $980-995M Expected Net Product Sales Positioning ARCALYST as 2nd line Standard of Care $677.6M Deepening penetration into 2+ recurrence population $417.0M Driving adoption among $233.2M larger 1st recurren
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
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
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-1α and IL-1β inhibition is well-established and well-tolerated • Mont
Slide 20: KPL-387 Program Aims to Address Key Patient Needs and Expand Market
KPL-387 Program Aims to Address Key Patient Needs and Expand Market The vast majority of surveyed HCPs report that an efficacious IL-1α & IL-1β inhibitor with the target profile of KPL-387 would be best positioned to address unmet needs of patients living with recurrent pericarditis and is likely to
Slide 21: KPL-387 Development Program
Registrational Program Includes Pivotal and Supplemental Components Treatment Phase Study Design & Type Patient Population Duration Event-Driven, Double-Blind, Pivotal Phase 3 Placebo-Controlled, Randomized- Qualifying Pericarditis Episode Event-Driven Study Withdrawal Study1 KPL-387 Development Pro
Slide 22: 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
Slide 23: Dose-Focusing Portion Builds on Precedent of Rilonacept Phase 2 Trial
Dose-Focusing Portion Builds on Precedent of Rilonacept Phase 2 Trial Cadence & magnitude of initial response and duration of action in Phase 2 inform Phase 3 efficacy, recurrence risk reduction Phase 2 Dose-Focusing Portion of Open-Label Phase 2 Clinical Trial of Rilonacept in Pericarditis Populati
Slide 24: Phase 2 Data Supported Selection of KPL-387 300 mg SC q4wk Dose Level
Phase 2 Data Supported Selection of KPL-387 300 mg SC q4wk Dose Level for Pivotal Phase 3 Study Primary and Secondary Endpoints* KPL-387 300 mg SC q4wk Time to Treatment Response1 4.0 (3.0, 6.0) days Time to Pain Response 4.0 (3.0, 6.0) days Time to CRP Normalization2 8.0 (7.0, 9.0) days *Reported a
Slide 25: Financials Second Quarter 2026
Financials Second Quarter 2026
Slide 26: Second Quarter 2026 Financial Results
Second Quarter 2026 Financial Results Collaboration Expenses1 Three Months Ended June 30, Income Statement Three Months Ended June 30, 2026 2025 2026 2025 ARCALYST Net Sales $243.6M $156.8M Product Revenue $243.6M $156.8M Profit Split-Eligible Cost of Goods Sold2 ($22.7M) ($18.4M) License and Collab
Slide 27: Appendix Out-Licensing Agreements
Appendix Out-Licensing Agreements
Slide 28: 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
Slide 29: Appendix ARCALYST
Appendix ARCALYST (rilonacept)
Slide 30: ARCALYST Monotherapy Provided Long-Term Prevention of Recurrence
ARCALYST Monotherapy Provided Long-Term Prevention of Recurrence Over Three-Year Duration of RHAPSODY RISK OF PERICARDITIS RECURRENCE WHILE ON ARCALYST MONOTHERAPY*1 FREEDOM FROM RECURRENCE (%) ** TIME ON CONTINUOUS ARCALYST MONOTHERAPY (MONTHS) A new integrated analysis of RHAPSODY supports evidenc
Slide 31: Real-World Outcomes Data Affirm Benefit of Sustained ARCALYST Treatment
Real-World Outcomes Data Affirm Benefit of Sustained ARCALYST Treatment Rilonacept provides superior clinical outcomes and reduced hospitalizations/ED visits versus 2nd-line glucocorticoids Clinical Outcomes and Healthcare Resource Utilization in Patients With RP *Patients remaining on NSAIDs ± Colc
Slide 32: 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
Slide 33: Rilonacept Initiation Resulted in Rapid Resolution of Acute Pericarditis Episodes
Rilonacept Initiation Resulted in Rapid Resolution of Acute Pericarditis Episodes RHAPSODY run-in period 6 6 Most patients experienced treatment response*, pain relief, and inflammation resolution as 97 % of patients (77 of 79) taking early as after the first dose2 ARCALYST experienced 4 treatment r
Slide 34: 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
Slide 35: 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 ARCALYST reduced the risk of pericarditis recurrence Recurrence-free rate was 97% (32 of 33) for ARCALYST and 25% (2 of 8) for those who suspended therapy 3% (1 of 33) of pa
Slide 36: 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
Slide 37: Appendix KPL-387
© Appendix KPL-387
Slide 38: KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial: Phase 2
KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial Phase 2: Dose-focusing study DOSE-FOCUSING : TREATMENT PERIOD (WEEKS 0-24) KPL-387 300 mg SC q2wk KPL-387 300 mg SC q4wk R LONG-TERM EXTENSION Screening 1:1:1:1 (UP TO 24 MONTHS) 2 KPL-387 100 mg SC q2wk KPL-387 100 mg SC q4wk NSAIDs and/or col
Slide 39: KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial: Phase 3
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
Slide 40: Transition to KPL-387 Monotherapy Dosing & Administration Study
Transition to KPL-387 Monotherapy Dosing & Administration Study Supplemental Phase 2 study evaluating efficacy and safety of dosing regimens used to transition patients to KPL-387 monotherapy from standard therapies Phase 2 Transition to KPL-387 Monotherapy Dosing & Administration Long-Term Extensio
Slide 41: 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)
Slide 42: 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 42
Slide 43: 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 Predicted KPL-387 Serum Concentration (μg/mL) Target Concentration Pharmacokinetic modeling of KPL-387 at the anticipated therapeutic dose supports the monthly dose paradigm 43
Slide 44: Appendix KPL-1161
, a KINIKSA XZ Appendix KPL-1161
Slide 45: IL-1α and IL-1β Inhibition is Well Established in Cardiovascular and Inflammatory Diseases
IL-1α and IL-1β Inhibition is Well Established in Cardiovascular and Inflammatory Diseases DIRA Indications with sJIA & Still’s Disease Regulatory Approval Periodic Fever Syndrome± Recurrent Pericarditis or Positive RCT Hidradenitis Suppurativa Trials Rheumatoid Arthritis* Acute Gout Flares* ASCVD*
Slide 46: Corporate Presentation
Corporate Presentation JULY 2026
Kiniksa Pharmaceuticals International — Q2 2026 Earnings Presentation on 6ix