Kiniksa二季度ARCALYST销售超预期并上调2026年收入指引

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ARCALYST
¨
(rilonacept) Q2 2026 net product revenue of $243.6 million, representing ~55%
year-over-year growth
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– ARCALYST 2026 expected net product revenue increased to $980 - $995 million
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– KPL-387 Phase 2 data demonstrated rapid and sustained reductions in pain and inflammation at 300 mg SC once-monthly, the dose level selected for Phase 3
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– KPL-387 pivotal Phase 3 trial in recurrent pericarditis now enrolling and dosing patients
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– Conference call and webcast scheduled for 8:30 am ET today
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LONDON, July 28, 2026 (GLOBE NEWSWIRE) --
Kiniksa Pharmaceuticals International, plc
(Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today reported second quarter 2026 financial results and recent portfolio execution.
“In the second quarter, Kiniksa continued to drive growth in new and repeat prescribers of ARCALYST in recurrent pericarditis, which led to a meaningful increase in patients on therapy. As a result, we have raised our 2026 ARCALYST net sales guidance to between $980 and $995 million,” said Sanj K. Patel, Chairman & Chief Executive Officer of Kiniksa. “In our clinical portfolio, KPL-387 Phase 2 data supported initiation of the pivotal Phase 3 trial, PASTORALE, which is now enrolling and dosing patients. We are excited to advance KPL-387 with its target product profile of once-monthly subcutaneous dosing in a liquid formulation. We expect to bring this potential additional treatment option to patients in the 2028/2029 timeframe. Additionally, we continue to develop KPL-1161 with a target profile of once-quarterly dosing and are on track to initiate a Phase 1 trial by the end of this year.”
Portfolio Execution
ARCALYST
(IL-1α and IL-1β cytokine trap)
ARCALYST net product revenue was $243.6 million for the second quarter of 2026.
As of the end of the second quarter of 2026, approximately 21% of the 14,000 multiple-recurrence patients were actively on ARCALYST treatment.
Since launch, more than 5,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
As of the end of the second quarter of 2026, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 3 years, in line with the median duration of disease.
KPL-387 (monoclonal antibody IL-1 receptor antagonist)
Kiniksa today announced data from an interval analysis of the ongoing KPL-387 Phase 2/3 trial in recurrent pericarditis. The Phase 2 dose-focusing portion of the trial is designed to evaluate the dose response and safety of different subcutaneously (SC) administered KPL-387 dose regimens and to support dose selection for the pivotal Phase 3 portion of the trial.
Participants in the KPL-387 300 mg SC monthly dose group experienced rapid and sustained reductions in Numeric Rating Scale (NRS) pain and inflammation as soon as after the first dose:
Primary Efficacy Endpoint
*
Time to Treatment Response
1
: 4.0 (3.0, 6.0) days.
Secondary Efficacy Endpoints
*
Time to Pain Response: 4.0 (3.0, 6.0) days.
Time to C-Reactive Protein (CRP) Normalization
2
: 8.0 (7.0, 9.0) days.
KPL-387 efficacy was durable throughout the monthly dosing interval.
KPL-387 was generally well-tolerated, consistent with the well-known safety profile of interleukin-1 (IL-1) pathway inhibition.
Kiniksa is enrolling and dosing patients in PASTORALE, the pivotal Phase 3 portion of the Phase 2/3 clinical trial.
PASTORALE is an event-driven, double-blind, placebo controlled, randomized withdrawal (RW) study enrolling up to approximately 85 participants with recurrent pericarditis. PASTORALE is evaluating the efficacy and safety of KPL-387 300 mg SC administered once-monthly in a liquid formulation.
The primary endpoint is time to first adjudicated pericarditis recurrence during the RW period.
Kiniksa is also conducting a supplemental Phase 2 Transition to KPL-387 Monotherapy Dosing & Administration Study evaluating the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy.
________________
*
Reported as median (95% confidence interval).
1
Treatment Response is defined as Pain Response (NRS score ≤ 2 on the 11-point daily pericarditis pain NRS pain scale) and at least one CRP level ≤ 0.5 mg/dL within 7 days before or after the Pain Response.
2
CRP Normalization is defined as CRP ≤ 0.5 mg/dL.
KPL-1161 (Fc-modified monoclonal antibody IL-1 receptor antagonist)
Kiniksa is conducting preclinical development activities with KPL-1161 with a target profile of quarterly SC dosing. The company expects to initiate a Phase 1 first-in-human clinical trial by the end of 2026.
Financial Results
Total revenue for the second quarter of 2026 was $243.6 million, compared to $156.8 million for the second quarter of 2025.
Total operating expenses for the second quarter of 2026 were $216.4 million, compared to $136.6 million for the second quarter of 2025, and comprised the following:
Cost of Goods Sold (COGS) expenses of $23.6 million, compared to $18.6 million for the second quarter of 2025. The increase in COGS expenses was primarily due to costs associated with increased sales of ARCALYST.
Collaboration expenses of $88.1 million, compared to $52.4 million for the second quarter of 2025. Collaboration expenses are driven primarily by ARCALYST collaboration profitability.
Research and Development (R&D) expenses of $40.9 million, compared to $18.8 million for the second quarter of 2025. The increase in R&D expenses was primarily due to increased KPL-387 clinical and manufacturing activity as well as increased preclinical development investment.
Selling, General, and Administrative (SG&A) expenses of $63.9 million, compared to $46.9 million for the second quarter of 2025. The increase in SG&A expenses was primarily due to investment associated with the commercialization of ARCALYST.
Total operating expenses for the second quarter of 2026 included $11.6 million in non-cash, share-based compensation expense, compared to $8.9 million for the second quarter of 2025.
Net income for the second quarter of 2026 was $25.4 million, compared to $17.8 million for the second quarter of 2025.
As of June 30, 2026, Kiniksa had $525.9 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
Kiniksa expects 2026 ARCALYST net product revenue of between $980 million and $995 million, compared to prior guidance of between $930 million and $945 million.
Kiniksa expects its current operating plan to remain cash flow positive on an annual basis.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 28, 2026, to discuss second quarter 2026 financial results and recent portfolio execution.
Individuals interested in participating in the call via telephone may register
here
. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.
About Kiniksa
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit
www.kiniksa.com
.
About ARCALYST
ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 bet