Key Highlights
- Third-quarter ARCALYST revenue was $286.0 million, up about 58% from $180.9 million.
- GAAP net income was $47.3 million, or $0.56 per diluted share, versus $18.4 million, or $0.23.
- 2026 ARCALYST revenue guidance rose to $1,045 million to $1,050 million from $980 million to $995 million.
- Cash and short-term investments were $568.8 million with no debt.
- About 23% of roughly 14,000 annual multiple-recurrence patients were on ARCALYST at quarter end.
Kiniksa Earnings: Is ARCALYST Heading Past $1 Billion?
Kiniksa Pharmaceuticals International (NASDAQ:KNSA) reported third-quarter results on Tuesday, October 27, with ARCALYST net revenue of $286.0 million, up about 58% from $180.9 million. GAAP diluted EPS was $0.56 against $0.23, versus a $0.31 estimate as screened. The company raised 2026 ARCALYST net revenue guidance to $1,045 million to $1,050 million from $980 million to $995 million.
That range sits above $1 billion. Revenue has risen from $243.6 million in the second quarter (calculated 17.4% sequential growth), and the nine-month total of $743.8 million compares with $475.4 million a year earlier.
Kiniksa is a biopharmaceutical company whose commercial product, ARCALYST, treats recurrent pericarditis, an inflammatory heart condition. All third-quarter revenue came from the product.
Profitability and Spending: How Much Reached the Bottom Line?
GAAP net income was $47.3 million against $18.4 million, and income from operations was $54.2 million against $24.0 million. Basic EPS was $0.61. Nine-month net income was $95.4 million, or $1.14 per diluted share, versus $44.8 million and $0.57.
Costs rose with sales. Cost of goods sold was $27.8 million, implying a gross margin of about 90.3% (calculated). Collaboration expenses rose to $105.8 million from $63.3 million, driven by ARCALYST collaboration profitability. R&D rose to $32.8 million from $24.2 million on KPL-387 clinical activity, and SG&A to $65.4 million from $49.1 million on commercialization investment.
Operating margin was about 19% (calculated). Non-cash share-based compensation was $13.1 million, against $10.1 million.
Nine-month R&D was $101.2 million against $62.2 million, and nine-month SG&A was $190.4 million against $139.5 million. Total assets were $983.2 million and shareholders' equity $710.2 million at quarter end.
Guidance and Demand: What Supports the Higher Range?
The chief executive credited strong commercial execution that increased patient and physician adoption. About 23% of roughly 14,000 annual multiple-recurrence patients were on ARCALYST at quarter end, more than 5,450 prescribers have written prescriptions since launch, and average therapy lasts about three years, in line with median disease duration.
Calculated against nine-month revenue of $743.8 million, the guidance implies roughly $301 million to $306 million in the fourth quarter. Other 2026 guidance is R&D of $160 million to $170 million and SG&A of $270 million to $280 million, with the operating plan expected to stay cash flow positive for the year.
Cash, equivalents and short-term investments were $568.8 million with no debt, up from $414.1 million at December 31, 2025.
The company did not report non-GAAP earnings, so the figures above are on a GAAP basis. No license or collaboration revenue was recorded in either period.
What to Watch Next: Can the KPL-387 Program Reduce Reliance on One Product?
KPL-387, an IL-1R1 antibody aimed at once-monthly dosing, is enrolling the pivotal Phase 3 PASTORALE trial, with data expected in the second half of 2027. KPL-1161, a quarterly-dosing candidate, is expected to start Phase 1 by the end of 2026. Fourth-quarter ARCALYST revenue against the implied range, and patient penetration beyond 23%, are the next markers.

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