Kiniksa Pharmaceuticals International plc-A 2025年度报告

Dear Fellow Shareholders, As the market leader, we are leveraging our existing clinical expertise toexplore additional efficacious treatment options for patients. With thisprogram, we are advancing a validated mechanism that could addresskey patient needs and expand penetration into the addressable market.We believe KPL-387 could enable once-monthly dosing with a singlesubcutaneous self-injection in a liquid formulation, offering convenientadministration using an autoinjector. In 2025, we initiated theregistrational Phase 2/3 development program of KPL-387 in recurrentpericarditis, with Phase 2 data expected in the second half of 2026. In 2025, Kiniksa continued to deliver meaningful progress across ourcommercial and clinical portfolio, helping patients suffering fromdebilitating diseases with significant unmet need. Continued ARCALYST commercial growth and disciplined capitalallocation position Kiniksa for near- and long-term success. We arebuilding the foundation for future growth through strategic investmentsin the commercialization of ARCALYST as well as the advancement ofour pipeline of interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β)inhibition assets. We are also conducting a supplemental Phase 2 Transition to KPL-387Monotherapy Dosing & Administration Study to provide healthcareprofessionals with additional information at the time of launch tosupport initiating KPL-387. ARCALYST ARCALYST, an IL-1α& IL-1βcytokine trap, is the only U.S. Food andDrug Administration (FDA)-approved therapy for the treatment ofrecurrent pericarditis and reduction in risk of recurrence. In the fiveyears since launch, ARCALYST has redefined the treatment paradigmfor this disease, establishing IL-1 pathway inhibition as the preferredsecond-line approach, ahead of corticosteroids. In August 2025, theAmerican College of Cardiology formally recognized this evolution withthe publication of its Concise Clinical Guidance, recommending IL-1pathway inhibition after the use of NSAIDs and colchicine for patientssuffering from recurrent pericarditis. Market research indicates there may be strong demand among thevast majority of surveyed patients and healthcare professionals for ahighly efficacious IL-1α& IL-1βinhibitor with the target profile of KPL-387.Approximately 75% of surveyed recurrent pericarditis patients wouldprefer a treatment with such a target profile over currently availableor other investigational therapies. Additionally, among ARCALYST-naïvepatients, approximately 75% stated an increased willingness to take aninjectable therapy if presented in an autoinjector. On the physician side,approximately 92% indicated a high likelihood of prescribing the KPL-387target profile for new patients, in the context of available commercialand investigational therapies. Both patient and physician preferenceshighlight the potential for KPL-387 to address key needs for those withrecurrent pericarditis. Expanding adoption of IL-1α& IL-1βinhibition with ARCALYST was theprimary driver of our robust commercial performance throughout2025. Over the course of the year, we saw meaningful increases in thebreadth and depth of prescribing, treatment duration, and penetrationacross the recurrent pericarditis population. More than 4,150 healthcareproviders have prescribed ARCALYST since launch, with approximately29% writing more than one prescription. Importantly, the majority ofnew prescriptions are coming from existing prescribers, speaking to theeffectiveness of our educational efforts and the growing appreciationphysicians have for ARCALYST as a safe and effective treatment that canbe used continuously throughout the duration of this chronic disease.Average total duration of therapy continues to grow and is approaching3 years, in line with the median duration of disease. As a result,approximately 18% of the annual target population of 14,000 patients withmultiple recurrences were actively on ARCALYST treatment as of the endof 2025. Furthermore, growing physician familiarity prescribing ARCALYSTis contributing to broader use in patients on their first recurrence, whoaccount for around 20% of ARCALYST prescriptions. The upside potentialwithin the additional 26,000 patients each year who experience theirfirst recurrence is large, particularly among those suffering fromadditional risk factors associated with longer disease duration. In October 2025, the FDA granted Orphan Drug Designation to KPL-387for the treatment of pericarditis, including recurrent pericarditis. We areworking diligently to bring this potential treatment option to patientsand are aiming to be on the market in the 2028/2029 timeframe. KPL-1161 KPL-1161 is an Fc-modified monoclonal antibody IL-1α& IL-1βantagonistdeveloped independently by Kiniksa that binds IL-1R1, with a targetprofile of once-quarterly subcutaneous dosing. We believe this profilemay support treatment across a range of cardiovascular and IL-1mediated diseases. KPL-1161 is currently in preclinical d