Kiniksa Pharmaceuticals International (KNSA) Company Report

Kiniksa reported $180.9 million in net product revenue for Q3 2025, representing a 61% year-over-year increase. The company also increased its net revenue guidance for full year 2025 to between $670 million and $675 million.
ARCALYST has generated over $1 billion in net product revenue since its FDA approval 4.5 years ago and has a 15% penetration rate in the multiple recurrence population.
The company's pipeline asset, KPL-387, received Orphan Drug Designation in October and is undergoing a Phase 2/3 development program, with the Phase 2 dose-focusing portion expected to read out in the second half of 2026.
Kiniksa reported $352 million in cash reserves at the time of its Q3 earnings.

Nov 17, 2025, 2:30 PM

Transcript

Kiniksa Updates on ARCALYST Revenue Guidance and KPL-387 Development

KNSA

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

Kiniksa reported Q3 net product revenue for ARCALYST of $180.9 million, representing a 61% year-over-year increase compared to Q3 2024. The company also increased its full-year 2025 net revenue guidance to between $670 million and $675 million.
Since its FDA approval approximately four and a half years ago, ARCALYST has delivered over $1 billion in net product revenue. The drug has achieved 15% penetration into the multiple recurrence population, and 20% of patients are now prescribed ARCALYST for their first recurrence, an increase from 15% a year ago.
The company's pipeline asset, KPL-387, received Orphan Drug Designation from the FDA in October for recurrent pericarditis. Phase 2 dose-focusing data from its Phase 2/3 development program is expected to read out in the second half of 2026.
Kiniksa maintains a strong financial position, reporting over $350 million in cash reserves at its Q3 earnings call.

Nov 17, 2025, 2:30 PM

Transcript

Kiniksa Provides Business Update and Increased 2025 Revenue Guidance

KNSA

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

Kiniksa increased its net revenue guidance for full year 2025 to between $670 million and $675 million and reported over $350 million in cash reserves at Q3 earnings.
The company's commercial product, ARCALYST, has generated over $1 billion in net product revenue since its FDA approval 4.5 years ago, with Q3 net product revenue reaching $180.9 million, a 61% year-over-year increase.
ARCALYST has achieved 15% penetration in the multiple recurrence population and is seeing increased adoption in first recurrence patients, now representing 20% of prescriptions.
Kiniksa is advancing its clinical pipeline, with KPL-387 for recurrent pericarditis receiving Orphan Drug Designation and its Phase II dose-focusing data expected in H2 2026. This monthly auto-injector is highly anticipated by patients and healthcare professionals.

Nov 17, 2025, 2:30 PM

Transcript

Kiniksa Pharmaceuticals announces Q3 2025 results and raises full-year guidance

KNSA

Earnings

Guidance Update

Revenue Acceleration/Inflection

Kiniksa Pharmaceuticals reported Q3 2025 ARCALYST revenue of $180.9 million, representing approximately 61% year-over-year growth.
The company raised its full-year 2025 net revenue guidance to between $670 million and $675 million from its previous guidance of $625 million and $640 million.
Net income for Q3 2025 was $18.4 million.
Kiniksa maintains a strong financial position with approximately $352.1 million in cash, cash equivalents, and short-term investments as of September 30, 2025, and expects its operating plan to remain cash flow positive on an annual basis.
KPL-387 received US Orphan Drug Designation for pericarditis, with Phase 2 data anticipated in the second half of 2026.

Oct 28, 2025, 12:30 PM

Presentation

Kiniksa Pharmaceuticals Reports Strong Q3 2025 Results and Raises Full-Year ARCALYST Sales Guidance

KNSA

Earnings

Guidance Update

Revenue Acceleration/Inflection

Kiniksa Pharmaceuticals reported Q3 2025 ARCALYST revenue of $180.9 million, marking a 61% year-over-year increase, and achieved a net income of $18.4 million for the quarter, compared to a net loss in the prior year.
The company raised its full-year 2025 ARCALYST net sales guidance to between $670 million and $675 million, an increase from its previous guidance of $625 million to $640 million.
Key drivers for ARCALYST's growth included the highest quarterly new patient enrollments since launch, an increase of over 350 new prescribers in Q3, and an average duration of therapy that extended to approximately 32 months.
KPL-387, Kiniksa's development program, received FDA orphan drug designation for pericarditis (including recurrent pericarditis) and is expected to report Phase 2 dose-focusing data in the second half of 2026.

Oct 28, 2025, 12:30 PM

Transcript

Kiniksa Reports Strong Q3 2025 Results and Raises Full-Year Guidance

KNSA

Earnings

Guidance Update

Revenue Acceleration/Inflection

Kiniksa (KNSA) reported ARCALYST revenue of $180.9 million in Q3 2025, representing a 61% year-over-year growth. This is approximately $24 million higher than the previous quarter and $69 million higher compared to Q3 2024.
The company raised its full-year 2025 net sales guidance for ARCALYST from the previous range of $625 million to $640 million to a new range of $670 million to $675 million, reflecting a $40 million increase at the midpoint.
Kiniksa achieved a net income of $18.4 million in Q3 2025, a significant improvement from a net loss of $12.7 million in the prior year quarter.
The company's cash balance increased by approximately $44 million to $352.1 million in Q3 2025, and it expects to remain cash flow positive on an annual basis.
The FDA granted KPL-387 orphan drug designation for the treatment of pericarditis, with Phase 2 data from the dose-focusing portion of the Phase 2/3 trial expected in the second half of next year.

Oct 28, 2025, 12:30 PM

Transcript

Kiniksa Pharmaceuticals Reports Strong Q3 2025 Financial Results and Raises ARCALYST Revenue Guidance

KNSA

Earnings

Guidance Update

New Projects/Investments

Kiniksa Pharmaceuticals reported total revenue of $180.9 million and net income of $18.4 million for the third quarter of 2025.
The company raised its 2025 ARCALYST net product revenue guidance to between $670 million and $675 million, up from prior guidance of $625 million to $640 million.
As of September 30, 2025, Kiniksa's cash, cash equivalents, and short-term investments increased to $352.1 million.
KPL-387 was granted Orphan Drug Designation for pericarditis, with Phase 2 dose-focusing data anticipated in the second half of 2026.

Oct 28, 2025, 11:39 AM

8-K

Kiniksa Pharmaceuticals Receives Orphan Drug Designation for KPL-387

KNSA

Regulatory Approval

New Projects/Investments

Kiniksa Pharmaceuticals International, plc (KNSA) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis.
KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines IL-1α and IL-1β.
This designation provides financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers, and waives the requirement to conduct pediatric studies for the product in the designated disease.
Kiniksa expects data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 recurrent pericarditis trial in the second half of 2026.

Oct 17, 2025, 12:00 PM

Press Release

Kiniksa Receives Orphan Drug Designation for KPL-387

KNSA

New Projects/Investments

Kiniksa Pharmaceuticals has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug KPL-387, which is aimed at treating pericarditis, including recurrent pericarditis.
KPL-387 is a monoclonal antibody that targets the human interleukin-1 receptor 1, designed for potential treatment through monthly subcutaneous self-injections.
This designation provides financial incentives such as grant funding, tax advantages, and user-fee waivers, and also waives the requirement for pediatric studies for KPL-387 in this designated disease.
Kiniksa expects data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 trial in the second half of 2026.

Oct 17, 2025, 2:07 AM

Morningstar

Earnings Transcripts

Quarterly earnings call transcripts for Kiniksa Pharmaceuticals International.

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