Kiniksa Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Portfolio Execution
Rhea-AI Summary
Kiniksa Pharmaceuticals (Nasdaq: KNSA) reported Q2 2026 total revenue of $243.6 million, all from ARCALYST, up about 55% year over year. Net income was $25.4 million versus $17.8 million a year earlier, with operating expenses rising to $216.4 million.
ARCALYST Q2 net product revenue was $243.6 million, and 2026 net product revenue guidance was raised to $980–$995 million, from $930–$945 million, according to Kiniksa. Cash, cash equivalents, and short-term investments were $525.9 million with no debt as of June 30, 2026.
KPL-387 Phase 2 data in recurrent pericarditis showed rapid median time to treatment response of 4 days at 300 mg SC monthly, supporting this dose for the pivotal Phase 3 PASTORALE trial, which is now enrolling. Kiniksa also plans to start a Phase 1 trial of KPL-1161 by year-end 2026.
Positive
- ARCALYST Q2 2026 revenue $243.6M, ~55% year-over-year growth
- 2026 ARCALYST guidance raised to $980–$995M from $930–$945M
- Q2 2026 net income $25.4M vs. $17.8M in Q2 2025
- Cash and investments $525.9M and no debt at June 30, 2026
- KPL-387 Phase 2 median 4-day treatment response at 300 mg SC monthly
- KPL-387 pivotal Phase 3 PASTORALE trial enrolling up to ~85 participants
Negative
- Total operating expenses $216.4M vs. $136.6M in Q2 2025
- Collaboration expenses $88.1M vs. $52.4M in Q2 2025
- R&D expenses $40.9M vs. $18.8M in Q2 2025
- SG&A expenses $63.9M vs. $46.9M in Q2 2025
News Explained
The disclosure quantifies ARCALYST’s reach and identifies recurrence timing as the primary endpoint for KPL-387’s enrolling Phase 3 study.
In its second-quarter update, Kiniksa reports that KPL-387’s pivotal Phase 3 PASTORALE study is enrolling and dosing patients.
At
PASTORALE is structured as a randomized-withdrawal study: after a single-blind run-in, participants achieving a clinical response are randomized 1:1 to monthly KPL-387 or placebo, with up to approximately 85 participants planned.
The named clinical checkpoint is time to the first adjudicated pericarditis recurrence during the randomized-withdrawal period, so enrollment and dosing have started before that endpoint is reported.
Market reaction after 2Q26 earnings report: KNSA +24.82%
Following this news, KNSA has gained 24.82%, reflecting a significant positive market reaction. Our momentum scanner has triggered 35 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $79.31. Trading volume is above average at 1.6x the average, suggesting increased trading activity.
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Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 28 | Q1 earnings report | Positive | +23.5% | Revenue growth, raised guidance, profitability, cash, and pipeline milestones |
| Feb 24 | Q4 earnings report | Positive | -8.2% | Revenue growth, 2026 guidance, cash increase, profitability, and pipeline plans |
| Oct 28 | Q3 earnings report | Positive | -2.9% | Revenue growth, raised guidance, profitability, cash increase, and KPL-387 designation |
| Jul 29 | Q2 earnings report | Positive | +12.3% | Revenue growth, raised guidance, profitability, cash, and KPL-387 trial progress |
| Apr 29 | Q1 earnings report | Positive | +20.5% | Revenue growth, raised guidance, profitability, cash, and planned clinical milestones |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
KNSA's tag-specific earnings history showed both positive and negative 24-hour reactions despite positive earnings-related announcements.
Key Terms
cytokine trap medical
monoclonal antibody medical
c-reactive protein medical
randomized withdrawal medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– ARCALYST¨ (rilonacept) Q2 2026 net product revenue of
– ARCALYST 2026 expected net product revenue increased to
– 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 –
– KPL-387 pivotal Phase 3 trial in recurrent pericarditis now enrolling and dosing patients –
– Conference call and webcast scheduled for 8:30 am ET today –
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
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 Response1: 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) Normalization2: 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 (
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.
- Cost of Goods Sold (COGS) expenses of
- 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 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 recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. 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 PASTORALE
PASTORALE is a double-blind, placebo controlled, randomized withdrawal (RW) study enrolling up to approximately 85 patients with recurrent pericarditis. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued. Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 300 mg SC once-monthly or placebo in an event-driven, double-blind, RW period. The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter a long-term extension.
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, including the data from the interval analysis of our Phase 2 clinical trial of KPL-387 in recurrent pericarditis; 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 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||
| June 30, | June 30, | |||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||
| Revenue: | ||||||||||||||||||
| Product revenue, net | $ | 243,600 | $ | 156,797 | $ | 457,866 | $ | 294,582 | ||||||||||
| License and collaboration revenue | — | — | — | — | ||||||||||||||
| Total revenue | 243,600 | 156,797 | 457,866 | 294,582 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Cost of goods sold | 23,572 | 18,603 | 44,368 | 36,471 | ||||||||||||||
| Collaboration expenses | 88,069 | 52,418 | 163,646 | 96,208 | ||||||||||||||
| Research and development | 40,899 | 18,753 | 68,374 | 38,078 | ||||||||||||||
| Selling, general and administrative | 63,866 | 46,863 | 125,017 | 90,393 | ||||||||||||||
| Total operating expenses | 216,406 | 136,637 | 401,405 | 261,150 | ||||||||||||||
| Income from operations | 27,194 | 20,160 | 56,461 | 33,432 | ||||||||||||||
| Other income, net | 3,951 | 2,717 | 7,365 | 5,010 | ||||||||||||||
| Income before income taxes | 31,145 | 22,877 | 63,826 | 38,442 | ||||||||||||||
| Provision for income taxes | (5,713 | ) | (5,045 | ) | (15,802 | ) | (12,071 | ) | ||||||||||
| Net income | $ | 25,432 | $ | 17,832 | $ | 48,024 | $ | 26,371 | ||||||||||
| Net income per share attributable to ordinary shareholders—basic | $ | 0.33 | $ | 0.24 | $ | 0.62 | $ | 0.36 | ||||||||||
| Net income per share attributable to ordinary shareholders—diluted | $ | 0.30 | $ | 0.23 | $ | 0.58 | $ | 0.34 | ||||||||||
| Weighted average ordinary shares outstanding—basic | 77,577,675 | 73,438,530 | 77,050,036 | 73,041,920 | ||||||||||||||
| Weighted average ordinary shares outstanding—diluted | 83,398,051 | 77,942,082 | 82,902,904 | 76,984,393 | ||||||||||||||
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | ||||||||
| SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| As of | ||||||||
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 525,928 | $ | 414,074 | ||||
| Working capital | 497,386 | 387,993 | ||||||
| Total assets | 896,110 | 763,633 | ||||||
| Accumulated deficit | (414,114 | ) | (462,138 | ) | ||||
| Total shareholders' equity | 654,149 | 567,606 | ||||||
