Kiniksa Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Portfolio Execution
Rhea-AI Summary
Kiniksa Pharmaceuticals (Nasdaq: KNSA) reported Q4 2025 ARCALYST net product revenue of $202.1M and full-year 2025 ARCALYST revenue of $677.6M, a 62% year-over-year increase. The company expects 2026 ARCALYST revenue of $900–$920M and plans KPL-387 Phase 2 data in 2H 2026 and a KPL-1161 Phase 1 start by end of 2026. Cash rose by $170.4M to $414.1M and full-year 2025 net income was $59.0M.
Positive
- ARCALYST revenue +62% YoY to $677.6M in 2025
- Q4 ARCALYST revenue of $202.1M
- 2026 ARCALYST guidance of $900–$920M
- Cash balance increased by $170.4M to $414.1M
- Full-year 2025 net income of $59.0M vs loss in 2024
Negative
- Total operating expenses rose to $600.3M in 2025 from $468.9M
- Collaboration expenses increased to $229.5M for full-year 2025
- Only ~18% of 14,000 multiple-recurrence patients were actively on ARCALYST at year-end
Key Figures
Market Reality Check
Peers on Argus
Sector peers showed mixed, generally modest moves, with momentum flags only on INDV (down about 1.61%), suggesting KNSA’s setup was driven more by company-specific factors than a broad group move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Oct 28 | Q3 2025 earnings | Positive | -2.9% | Strong Q3 ARCALYST growth and guidance raise with pipeline progress. |
| Jul 29 | Q2 2025 earnings | Positive | +12.3% | Q2 beat, higher 2025 guidance and solid profitability metrics. |
| Apr 29 | Q1 2025 earnings | Positive | +20.5% | Strong Q1 ARCALYST growth and first quarter of net income. |
| Feb 25 | FY 2024 earnings | Positive | +0.5% | Robust 2024 ARCALYST growth and 2025 revenue outlook initiation. |
| Oct 29 | Q3 2024 earnings | Positive | -15.7% | Strong Q3 2024 growth and guidance raise despite reported net loss. |
Earnings updates have often been fundamentally strong, with mostly positive price reactions but some notable negative divergences.
Over the past year, Kiniksa’s earnings reports have highlighted rapid ARCALYST growth, repeated guidance raises, and a shift from net losses to net income (e.g., Q1 2025 net income of $8.5M). Cash has steadily increased while the company maintained no debt. Pipeline updates have focused on advancing KPL-387 into Phase 2/3 and preparing KPL-1161 for the clinic. Today’s full-year 2025 results and 2026 revenue outlook continue this theme of scaling ARCALYST and funding cardiovascular pipeline expansion from a profitable base.
Historical Comparison
In the past year, KNSA has issued 5 earnings updates with an average move of 2.95%, mixing strong fundamental beats with occasionally negative reactions.
Earnings reports show ARCALYST revenue scaling each quarter, repeated guidance raises, and a transition from net losses to consistent net income while advancing KPL-387 into Phase 2/3 and preparing KPL-1161 for first-in-human studies.
Market Pulse Summary
This announcement underscores Kiniksa’s transition to a profitable, cash-generative model, with ARCALYST delivering $677.6M in 2025 revenue and full-year net income of $59.0M. Guidance for 2026 ARCALYST revenue of $900–$920M and a cash balance of $414.1M support ongoing investment in KPL-387 and KPL-1161. Investors may track future earnings for continued revenue growth, margin trends, and progress toward the KPL-387 Phase 2/3 data expected in 2H 2026.
Key Terms
Phase 2/3 medical
Phase 2 medical
Phase 1 medical
monoclonal antibody medical
Fc-modified medical
subcutaneous medical
AI-generated analysis. Not financial advice.
– ARCALYST® (rilonacept) Q4 2025 and full year 2025 net product revenue of
– ARCALYST 2026 net product revenue expected to be
– KPL-387 Phase 2 recurrent pericarditis data expected in 2H 2026 –
– KPL-1161 Phase 1 trial planned to initiate by the end of 2026 –
– Cash balance increased by
– Conference call and webcast scheduled for 8:30 am ET today –
LONDON, Feb. 24, 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 fourth quarter and full year 2025 financial results and recent portfolio execution.
“Kiniksa continued to drive significant advancements across its commercial and clinical portfolio in 2025. The expanding adoption of IL-1α & IL-1β inhibition with ARCALYST as the preferred second-line treatment for recurrent pericarditis helped drive
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
- ARCALYST net product revenue was
$202.1 million and$677.6 million for the fourth quarter and full year 2025, respectively.- Gross-to-net was
8.4% for the full year 2025 compared to9.8% for the full year 2024, due to the impact of the Inflation Reduction Act throughout 2025, as well as prior period reserve adjustments in the fourth quarter of 2025.
- Gross-to-net was
- As of the end of the fourth quarter of 2025, approximately
18% of the 14,000 multiple-recurrence patients were actively on ARCALYST treatment. - Since launch, more than 4,150 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
- Average total duration of ARCALYST therapy in recurrent pericarditis continues to grow and is approaching 3 years, in line with the median duration of disease.
KPL-387 (monoclonal antibody IL-1 receptor antagonist)
- Kiniksa is conducting a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis and expects data from the dose-focusing portion of the trial in the second half of 2026.
- Kiniksa is conducting a supplemental Phase 2 Transition to KPL-387 Monotherapy Dosing & Administration Study evaluating the efficacy and safety of the dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy.
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 subcutaneous (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 fourth quarter of 2025 was
$202.1 million , compared to$122.5 million for the fourth quarter of 2024.- Total revenue for the fourth quarter of 2025 and the fourth quarter of 2024 did not include any license and collaboration revenue.
- Total revenue for the full year 2025 was
$677.6 million , compared to$423.2 million for the full year 2024.- Total revenue for the full year 2025 did not include any license and collaboration revenue, compared to
$6.2 million for the full year 2024.
- Total revenue for the full year 2025 did not include any license and collaboration revenue, compared to
- Total operating expenses for the fourth quarter of 2025 were
$182.4 million , compared to$141.8 million for the fourth quarter of 2024.- Total operating expenses for the fourth quarter of 2025 included
$70.0 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to$48.2 million for the fourth quarter of 2024.1 - Total operating expenses for the fourth quarter of 2025 included
$10.2 million in non-cash, share-based compensation expense, compared to$8.3 million for the fourth quarter of 2024.
- Total operating expenses for the fourth quarter of 2025 included
- Total operating expenses for the full year 2025 were
$600.3 million , compared to$468.9 million for the full year 2024.- Total operating expenses for the full year 2025 included
$229.5 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to$128.3 million for the full year 2024.1 - Total operating expenses for the full year 2025 included
$37.0 million in non-cash, share-based compensation expense, compared to$30.7 million for the full year 2024.
- Total operating expenses for the full year 2025 included
- Net income for the fourth quarter of 2025 was
$14.2 million , compared to a net loss of$8.9 million for the fourth quarter of 2024. - Net income for the full year 2025 was
$59.0 million , compared to net loss of$43.2 million for the full year 2024. - As of December 31, 2025, Kiniksa had
$414.1 million of cash, cash equivalents, and short-term investments and no debt, compared to$243.6 million as of December 31, 2024.
Financial Guidance
- Kiniksa expects 2026 ARCALYST net product revenue of between
$900 million and$920 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, February 24, 2026, to discuss fourth quarter and full year 2025 financial results and to provide a corporate update.
- 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 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is also approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older, and the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more. The FDA granted Orphan Drug Exclusivity to ARCALYST upon its approval for recurrent pericarditis in 2021. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021.
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
- ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).
- While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection.
- Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST.
- Medicines that affect the immune system may increase the risk of getting cancer.
- Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction.
- Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides.
- Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose.
For more information about ARCALYST, talk to your doctor and see the Product Information.
About KPL-387
KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by potentially enabling dosing with a single monthly SC self-injection in a liquid formulation. In October 2025, the FDA granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis.
About KPL-1161
KPL-1161 is an independently developed, investigational, Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, with a target profile of quarterly SC dosing. Kiniksa is currently engaging in preclinical development activities for KPL-1161.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2026 net product revenue will be between
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services; and the impact of global economic policy, including any uncertainty in national and international markets.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc.
Every Second Counts! ®
Kiniksa Investor & Media Contact
Jonathan Kirshenbaum
(781) 829-3949
jkirshenbaum@kiniksa.com
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | |||||||||||||||||
| SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
| (In thousands) | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| Three Months Ended | Years Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Revenue: | |||||||||||||||||
| Product revenue, net | $ | 202,127 | $ | 122,536 | $ | 677,564 | $ | 417,029 | |||||||||
| License and collaboration revenue | — | — | — | 6,210 | |||||||||||||
| Total revenue | 202,127 | 122,536 | 677,564 | 423,239 | |||||||||||||
| Costs and operating expenses: | |||||||||||||||||
| Cost of goods sold | 20,945 | 17,896 | 77,673 | 60,910 | |||||||||||||
| Collaboration expenses | 70,030 | 48,189 | 229,545 | 128,311 | |||||||||||||
| Research and development | 34,609 | 35,215 | 96,853 | 111,623 | |||||||||||||
| Selling, general and administrative | 56,775 | 40,535 | 196,272 | 168,011 | |||||||||||||
| Total operating expenses | 182,359 | 141,835 | 600,343 | 468,855 | |||||||||||||
| Income (loss) from operations | 19,768 | (19,299 | ) | 77,221 | (45,616 | ) | |||||||||||
| Other income, net | 3,501 | 2,320 | 11,647 | 9,464 | |||||||||||||
| Income (loss) before income taxes | 23,269 | (16,979 | ) | 88,868 | (36,152 | ) | |||||||||||
| Benefit (provision) for income taxes | (9,070 | ) | 8,091 | (29,863 | ) | (7,041 | ) | ||||||||||
| Net income (loss) | $ | 14,199 | $ | (8,888 | ) | $ | 59,005 | $ | (43,193 | ) | |||||||
| Net income (loss) per share attributable to ordinary shareholders—basic | $ | 0.19 | $ | (0.12 | ) | $ | 0.80 | $ | (0.60 | ) | |||||||
| Net income (loss) per share attributable to ordinary shareholders—diluted | $ | 0.17 | $ | (0.12 | ) | $ | 0.75 | $ | (0.60 | ) | |||||||
| Weighted average ordinary shares outstanding—basic | 75,967,217 | 72,319,129 | 74,200,924 | 71,424,159 | |||||||||||||
| Weighted average ordinary shares outstanding—diluted | 81,566,313 | 72,319,129 | 78,979,030 | 71,424,159 | |||||||||||||
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | ||||||||
| SELECTED CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| As of | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 414,074 | $ | 243,627 | ||||
| Working capital | 387,993 | 231,178 | ||||||
| Total assets | 763,633 | 580,553 | ||||||
| Accumulated deficit | (462,138 | ) | (521,143 | ) | ||||
| Total shareholders' equity | 567,606 | 438,436 | ||||||
1 Q4 2024 and 2024 collaboration expenses included a
FAQ
What were Kiniksa (KNSA) ARCALYST revenues for Q4 and full year 2025?
What is Kiniksa's (KNSA) 2026 revenue guidance for ARCALYST?
When does Kiniksa (KNSA) expect data for KPL-387 in recurrent pericarditis?
What are Kiniksa's (KNSA) cash and balance-sheet highlights as of Dec 31, 2025?
How did Kiniksa's (KNSA) operating expenses change in 2025 versus 2024?
When will Kiniksa (KNSA) initiate the Phase 1 trial for KPL-1161?
