Kiniksa Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $286.0 million, up from $180.9 million in Q3 2025.
• Net income for Q3 2026 was $47.3 million, compared to $18.4 million in Q3 2025.
• Total operating expenses for Q3 2026 were $231.7 million, compared to $156.8 million in Q3 2025.
• Cost of Goods Sold (COGS) was $27.8 million in Q3 2026, up from $20.3 million in Q3 2025, driven by increased ARCALYST sales.
• Collaboration expenses were $105.8 million in Q3 2026, up from $63.3 million in Q3 2025, driven by ARCALYST collaboration profitability.
• Research and Development (R&D) expenses were $32.8 million in Q3 2026, up from $24.2 million in Q3 2025, due to increased KPL-387 clinical activity.
• Selling, General, and Administrative (SG&A) expenses were $65.4 million in Q3 2026, up from $49.1 million in Q3 2025, due to commercialization investment for ARCALYST.
• Non-cash share-based compensation expense was $13.1 million in Q3 2026, compared to $10.1 million in Q3 2025.
• As of September 30, 2026, the company held $568.8 million in cash, cash equivalents, and short-term investments with no debt.

Guidance and Future Outlook:

• 2026 ARCALYST net product revenue guidance increased to $1.045 billion – $1.050 billion, up from the previous range of $980 million – $995 million.
• 2026 R&D expenses are expected to be between $160 million and $170 million.
• 2026 SG&A expenses are expected to be between $270 million and $280 million.
• The company expects its current operating plan to remain cash flow positive on an annual basis.
• KPL-387 pivotal Phase 3 data (PASTORALE trial) is expected in the second half of 2027, with a goal to bring the treatment to patients in the 2028/2029 timeframe.
• A Phase 1 trial for KPL-1161 is expected to be initiated by the end of 2026.

Business Segments and Product Lines:

• ARCALYST net product revenue for Q3 2026 was $286.0 million, representing approximately 58% year-over-year growth.
• As of Q3 2026, approximately 23% of the 14,000 annual multiple-recurrence patients were actively on ARCALYST treatment.
• Since launch, more than 5,450 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
• The average total duration of ARCALYST therapy in recurrent pericarditis is approximately 3 years, in line with the median duration of disease.
• KPL-387 is currently enrolling and dosing patients in the Phase 3 PASTORALE trial evaluating once-monthly subcutaneous dosing.
• A supplemental Phase 2 Transition to KPL-387 Monotherapy Dosing and Administration Study is ongoing to evaluate transitioning patients from standard therapies to KPL-387 monotherapy.
• KPL-1161 is an Fc-modified monoclonal antibody with a target profile of quarterly subcutaneous dosing.

Market and Competitive Landscape:

• The company states that strong commercial execution led to gains in patient and physician adoption for ARCALYST.
• ARCALYST is positioned to achieve blockbuster status in 2026.
• The company focuses on developing a leading IL-1α and IL-1β inhibition franchise.

Risks and Challenges:

• ARCALYST may affect the immune system, lowering the ability to fight infections, with serious infections including life-threatening infections and death having occurred.
• Patients taking ARCALYST should not take other medicines that block interleukin-1 or tumor necrosis factor due to increased infection risk.
• Medicines affecting the immune system may increase the risk of getting cancer.
• Common side effects include injection-site reactions, upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose.
• Potential risks include delays in clinical trial enrollment, negative or inconclusive clinical data, regulatory delays or denials, supply chain shortages, and competition.

Management Commentary and Tone:

• Sanj K. Patel, Chairman & CEO, stated that strong commercial execution resulted in revenue of $286.0 million and positioned ARCALYST for blockbuster status.
• Management expressed confidence that the robust financial position supports continued investment in ARCALYST, KPL-387, and KPL-1161.
• Management remains on track to initiate the Phase 1 trial of KPL-1161 by the end of 2026.

Other Key Points:

• The conference call and webcast to discuss results were scheduled for 8:30 a.m. ET on October 27, 2026.
• A replay of the event will be available on the company's website within approximately 48 hours.
• ARCALYST holds FDA Breakthrough Therapy designation for recurrent pericarditis and Orphan Drug exclusivity for recurrent pericarditis and reduction in risk of recurrence.
• KPL-387 received FDA Orphan Drug Designation for the treatment of pericarditis in October 2025.
• The PASTORALE trial is a double-blind, placebo-controlled, randomized withdrawal study enrolling up to approximately 85 patients.