Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — Investor Presentation (June 2025)
36 slides from Kiniksa Pharmaceuticals International's investor presentation, Jun 5, 2025
Slide 1: Corporate Presentation June 2025
Corporate Presentation JUNE 2025
Slide 2: Forward-looking statements
2 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 otherwise requires, “Kinik
Slide 3: Addressing Unmet Need is at the Heart of What We Do
3 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 1) As of year - end 2024. Advancing Clinical Portf
Slide 4: Pipeline
4 1) Approved in the U.S.; ARCALYST is also approved in the U.S. for cryopyrin - associated periodic syndromes (CAPS) and deficiency of the interleukin - 1 receptor antagonist (DIRA); 2) The FDA granted Breakthrough Therapy designation to ARCALYST for recurrent pericarditis in 2019; the FDA granted
Slide 5: ARCALYST IL-1α and IL-1β cytokine trap
ARCALYST ® IL - 1α AND IL - 1β CYTOKINE TRAP DISEASE AREA: Recurrent pericarditis 1 ; painful and debilitating autoinflammatory cardiovascular disease COMPETITION 2 : First and only FDA - approved therapy for recurrent pericarditis REGULATORY: U.S. Orphan Drug exclusivity for treatment of and reduct
Slide 6: Pericarditis Epidemiology
~160,000: Epidemiological analysis using large national surveillance databases to calculate the pooled annualized prevalence of pericarditis (Basis for Orphan Drug Designation) 2 ~40,000: Up to 30% experience at least one recurrence; some recur over multiple years 3,4 ~14,000: Nearly 50% annual turn
Slide 7: The Autoinflammatory Cycle of Recurrent Pericarditis
7 The Autoinflammatory Cycle of Recurrent Pericarditis: Tissue damage caused by IL - 1α and IL - 1β in the pericardium stimulates additional IL - 1α and IL - 1β, thereby creating a cycle of perpetual pericardial inflammation CRP, C - reactive protein; DAMPs, damage - associated molecular patterns; I
Slide 8: ARCALYST increasingly the 2nd line treatment of choice
8 ARCALYST has increasingly become the 2 nd line treatment of choice, after NSAIDs/colchicine, at leading expert centers across the U.S. Proportional use of corticosteroids has decreased ; P =0.0169 † Proportional use of ARCALYST ‡ has increased ; P =0.0024 † TREATMENT CHOICE OVER TIME IN PATIENTS F
Slide 9: Commercial Experience Highlights Successful Targeting Strategy
Commercial Experience Highlights Successful Targeting Strategy with Further Upside Potential ARCALYST PATIENTS BY FLARE STATUS AT INITIATION 1 IN ACTIVE FLARE ~80% NOT IN ACTIVE FLARE ~20% Only ~13% penetration into the 14K target population at the end of Q4 2024 SIGNIFICANT MARKET POTENTIAL 9 % of
Slide 10: Strong ARCALYST Growth Driven by Robust Commercial Execution
Strong ARCALYST Growth Driven by Robust Commercial Execution 10 Year - Over - Year Net Revenue Growth >3,150 Total Prescribers 1 ~820 Repeat Prescribers 1 >90% Payer Approval 1 (% of Completed Cases) ~30 months Average Total Duration of Therapy 1 >85% Patient Compliance 1 Key Revenue Drivers 1) Data
Slide 11: Commercial priorities to identify more patients
11 Promote to the full scope of the broad label to identify more patients Ensure positive prescriber experience to support repeat prescribing Support creation of an efficient network of care with regional centers of excellence Educate on data related to duration of disease and treatment to support l
Slide 12: ARCALYST Patient Flow
12 Time ARCALYST Patient Flow New to Brand Patients Patient Stops Patient Restarts Active Patients Strong steady growth: >3,150 unique prescribers; ~26% of which are repeat prescribers Increases over time as base of active ARCALYST patients grows with Initial Starts and Restarts Increases over time
Slide 13: Patients Restarted Therapy; Duration of Therapy
13 ~45% Of Patients Restarted Therapy Following Initial Discontinuation (Within ~8 weeks) Average Initial Duration of Therapy ~17 Months 1 Median Initial Duration of Therapy ~12 Months 1 ~30 Months Average Total Duration of Therapy After Accounting for Patient Restarts Average Total Duration of ARCA
Slide 14: Total and Repeat Prescribers of ARCALYST
Q1 2022 Q1 2025 Q1 2023 Q1 2024 Prescribers with 1 Recurrent Pericarditis Prescription Prescribers with ≥2 Recurrent Pericarditis Prescriptions 14 Total and Repeat Prescribers of ARCALYST for Recurrent Pericarditis Patients • Strong, steady growth in both new and repeat prescribers , supporting long
Slide 15: ARCALYST pricing and access
• ARCALYST list price of $23,846 per month Based on first and only FDA - approved therapy for recurrent pericarditis, in - line with specialty biologics with Breakthrough Therapy and Orphan Drug designation • Helping to ensure patient affordability and access to treatment is one of our core principl
Slide 16: 2025 ARCALYST Net Product Sales Guidance
$233.2M $122.5M $38.5M 1 $417.0M 2022 2023 2024 2025 2025 ARCALYST Net Product Sales Guidance Revenue guidance increased to $590 - $605M from $560 - $580M based on accelerated growth year - to - date 16 $590 - 605M Expected Net Product Sales 2021 1) 2021 = 9 months of availability (Q2 - Q4)
Slide 17: Kiniksa Operating Income from ARCALYST
Kiniksa Operating Income from ARCALYST • Kiniksa is responsible for sales and distribution of ARCALYST in all approved indications in the United States. • Kiniksa’s license to ARCALYST includes worldwide rights * , excluding MENA, for all applications other than those in oncology and local administr
Slide 18: KPL-387
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 recurrent pericarditis 1 - 3 STATUS: Phase 1 SAD/MAD study ongoing; pivotal Phase 2/3 clin
Slide 19: KPL-387: Independently Developed IL-1 Receptor Antagonist
19 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 we
Slide 20: KPL-387 Phase 1 SAD/MAD Study
20 KPL - 387 Phase 1 SAD/MAD Study 3 mg (4 active/2 placebo) 2 30 mg (6 active/2 placebo) 4 100 mg (6 active/2 placebo) 5 300 mg (6 active/2 placebo) 6 600 mg (6 active/2 placebo) 7 10 mg (6 active/2 placebo) 3 1 mg (4 active/2 placebo) 1 SC Administration 300 mg (6 active/2 placebo) 10 1000 mg (6 a
Slide 21: Single-Dose PK of KPL-387 Supports Monthly Dose Paradigm
21 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
Slide 22: PK Modeling and Dose Simulations for KPL-387 Phase 2/3
PK - Modeling and Dose Simulations for KPL - 387 Phase 2/3 RP Study 22 Target Concentration Pharmacokinetic modeling of KPL - 387 at the anticipated therapeutic dose supports the monthly dose paradigm
Slide 23: KPL-387 Phase 2/3 Recurrent Pericarditis Clinical Trial
Population: • Up to ~85 patients diagnosed with RP presenting at screening with a qualifying pericarditis episode despite treatment with conventional oral therapies. KPL - 387 Phase 2/3 Recurrent Pericarditis Clinical Trial 1) KPL - 387 will be administered in addition to conventional oral pericardi
Slide 24: Financials First Quarter 2025
Financials First Quarter 2025
Slide 25: First Quarter 2025 Financial Results
First Quarter 2025 Financial Results 25 Current Operating Plan Expected to Remain Cash Flow Positive on an Annual Basis 1) Subject to the terms of the definitive agreements between Kiniksa and Regeneron; 50% of ARCALYST Collaboration Operating Profit plus 50% of ARCALYST Licensing Proceeds; 2) Profi
Slide 26: Appendix: Out-Licensing Agreements
Appendix Out - Licensing Agreements
Slide 27: Partnerships with Huadong Medicine and Roche Genentech
27 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 countries in the Asia P
Slide 28: Appendix: ARCALYST (rilonacept)
Appendix ARCALYST (rilonacept)
Slide 29: RHAPSODY trial design
Screening Period Long - Term Extension (LTE) (up to 24 months) Loading Dose 320 mg SC Randomization 1:1 Primary Efficacy Endpoint Time - to - First - Adjudicated Pericarditis - Recurrence End of Treatment End of Study Open - Label Rilonacept 160 mg SC weekly a The duration of the run - in period was
Slide 30: ARCALYST reduced the risk of pericarditis recurrence
30 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 not be estimated due to the low number of recurrences ● 2 of 30 of patients
Slide 31: RHAPSODY Long-Term Extension Data
31 1) Imazio M, Klein AL, et al. Prolonged Rilonacept Treatment in Rhapsody Long - term Extension Provided Persistent Reduction of Pericarditis Recurrence Risk. Poster 2223 (Presented at AHA Scientific Sessions 2022). RHAPSODY Long - Term Extension Data Demonstrated Rilonacept Treatment Beyond 18 Mo
Slide 32: Randomized Phase 2 Trial of Rilonacept in Cardiac Sarcoidosis
32 Randomized Phase 2 Trial of Rilonacept in Cardiac Sarcoidosis Collaborative study agreement with Mayo Clinic and The Johns Hopkins University Primary Efficacy Endpoint • Change from baseline in number of segments with FDG uptake on cardiac FDG - PET scan at Week 24 Key Secondary Endpoints • Chang
Slide 33: Appendix: KPL-387
ae KINIKSA XZ Appendix KPL-387
Slide 34: KPL-387 Phase 2/3 Trial: Phase 2 Dose-Focusing Study
KPL - 387 Phase 2/3 Recurrent Pericarditis Clinical Trial Phase 2: Dose - focusing study 1) KPL - 387 will be administered in addition to conventional oral pericarditis medications (NSAIDs and/or colchicine) from baseline to Week 1 and then weaned off pericarditis medications to achieve KPL - 387 mo
Slide 35: KPL-387 Phase 3 Pivotal Study
Population: • Up to ~85 patients diagnosed with RP presenting at screening with a qualifying pericarditis episode despite treatment with conventional oral therapies. KPL - 387 Phase 2/3 Recurrent Pericarditis Clinical Trial Phase 3: Pivotal study Primary Efficacy Endpoint Time - to - first - adjudic
Slide 36: Corporate Presentation JUNE 2025
Corporate Presentation JUNE 2025
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