Kiniksa Pharmaceuticals International, plc

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, and our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in the Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the risks identified in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q, and our other filings with the Securities and Exchange Commission (the “SEC”) our actual results could differ materially from the results, performance or achievements expressed in or implied by these forward-looking statements.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, and our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in the Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the risks identified in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q (including this Quarterly Report), and our other filings with the Securities and Exchange Commission (the “SEC”) our actual results could differ materially from the results, performance or achievements expressed in or implied by these forward-looking statements.

Previous wording

ARCALYST is an interleukin-1α (“IL-1α”) and interleukin-1β (“IL-1β”) cytokine trap. In 2017, we licensed ARCALYST from Regeneron, which discovered and initially developed the drug. Our exclusive license to ARCALYST from Regeneron includes worldwide rights, excluding the Middle East and North Africa, for all applications other than those in oncology and local administration to the eye or ear. We received FDA approval of ARCALYST for thetreatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older in March 2021. Recurrent pericarditis is a painful inflammatory cardiovascular disease with an estimated United States prevalent population of approximately 40,000 patients seeking and receiving medical treatment. ARCALYST is also approved in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (“CAPS”), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 years and older, and the maintenance of remission in Deficiency of Interleukin-1 Receptor Antagonist (“DIRA”) in adults and children weighing 10 kg or more. ARCALYST is commercially available across the United States through a select network of specialty pharmacies. We are responsible for sales and distribution of ARCALYST in all approved indications in the United States, and evenly split profits on sales, as well as third party proceeds, with Regeneron. In 2022, we granted Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong”) exclusive rights to develop and commercialize ARCALYST in the Huadong Territory (as defined below). In 2023, Regeneron initiated a technology transfer of the manufacturing process for ARCALYST drug substance. Since then we have worked to qualify Samsung Biologics Co., Ltd. (“Samsung”) as our replacement contract development and manufacturing organization (“CDMO”) and, in April 2026, the FDA accepted the supplemental biologics license application related to such technology transfer and assigned a Prescription Drug User Fee Act target action date of June 19, 2026. In December 2024, we initiated a collaborative study agreement with The Mayo Clinic (together with Johns Hopkins University) to investigate the effects of ARCALYST in the treatment of cardiac sarcoidosis.

Current wording

ARCALYST is an interleukin-1α (“IL-1α”) and interleukin-1β (“IL-1β”) cytokine trap. In 2017, we licensed ARCALYST from Regeneron, which discovered and initially developed the drug. Our exclusive license to ARCALYST from Regeneron includes worldwide rights, excluding the Middle East and North Africa, for all applications other than those in oncology and local administration to the eye or ear. We received FDA approval of ARCALYST for thetreatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older in March 2021. Recurrent pericarditis is a painful inflammatory cardiovascular disease with an estimated United States prevalent population of approximately 40,000 patients seeking and receiving medical treatment. ARCALYST is also approved in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (“CAPS”), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 years and older, and the maintenance of remission in Deficiency of Interleukin-1 Receptor Antagonist (“DIRA”) in adults and children weighing 10 kg or more. ARCALYST is commercially available across the United States through a select network of specialty pharmacies. We are responsible for sales and distribution of ARCALYST in all approved indications in the United States, and evenly split profits on sales, as well as third party proceeds, with Regeneron. In 2022, we granted Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong”) exclusive rights to develop and commercialize ARCALYST in the Huadong Territory (as defined below). In 2023, Regeneron initiated a technology transfer of the manufacturing process for ARCALYST drug substance, and in June 2026 the FDA approved Samsung Biologics Co., Ltd. (“Samsung”) as our replacement contract development and manufacturing organization (“CDMO”). In December 2024, we initiated a collaborative study agreement with The Mayo Clinic (together with Johns Hopkins University) to investigate the effects of ARCALYST in the treatment of cardiac sarcoidosis.

Previous wording

KPL-387 is an investigational, fully human immunoglobulin G2 monoclonal antibody that binds human interleukin-1 receptor 1 (“IL-1R1”), inhibiting IL-1α- and IL-1β-mediated signaling. KPL-387 is an independently developed asset that we believe may expand the recurrent pericarditis market and provide an additional treatment option for patients, with the potential to add the convenience of monthly subcutaneous self-administration with a liquid formulation. In July 2025, we announced that the Phase 2 dose-focusing portion of the Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis had begun recruiting. We expect data from the Phase 2 portion of the trial in the second half of 2026 and plan to use the totality of the data to determine further development strategy. In September 2025, we announced plans to conduct a supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study to evaluate the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy. In April 2026, we announced our expectation to initiate a pivotal Phase 3 clinical trial of KPL-387 in recurrent pericarditis by the end of 2026. In October 2025, the FDA granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis.

Current wording

KPL-387 is an investigational, fully human immunoglobulin G2 monoclonal antibody that binds human interleukin-1 receptor 1 (“IL-1R1”), inhibiting IL-1α- and IL-1β-mediated signaling. KPL-387 is an independently developed asset that we believe may expand the recurrent pericarditis market and provide an additional treatment option for patients, with the potential to add the convenience of monthly subcutaneous self-administration with a liquid formulation. In July 2026, we announced that the pivotal Phase 3 trial of KPL-387 in recurrent pericarditis, PASTORALE, had begun enrolling and dosing patients, supported by Phase 2 data at the 300 mg subcutaneous monthly dose level. In addition, we announced that we expect to begin commercializing KPL-387 in 2028 or 2029. We are also conducting a supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study to evaluate the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy. The FDA previously granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis.

Previous wording

Under the Huadong Collaboration Agreement, we received a total upfront cash payment of $12.0 million for the Huadong Territory license of ARCALYST. In the fourth quarter of 2024, following the achievement of a regulatory milestone under the Huadong Collaboration Agreement, Huadong became obligated to make an additional cash payment of $20.0 million, which was received in the first quarter of 2025. In addition, we will be eligible to receive additional contingent sales-based milestones payments related to ARCALYST. Huadong will also be obligated to pay us tiered percentage royalties on ARCALYST ranging from the low-to-mid teens on annual net sales in the Huadong Territory, subject to certain reductions tied to ARCALYST manufacturing costs and certain other customary reductions, with an aggregate minimum floor. Royalties will be payable on a country-by-country or region-by-region basis until the later of

Current wording

Under the Huadong Collaboration Agreement, we received a total upfront cash payment of $12.0 million for the Huadong Territory license of ARCALYST. In the fourth quarter of 2024, following the achievement of a regulatory milestone under the Huadong Collaboration Agreement, Huadong became obligated to make an additional cash payment of $20.0 million, which was received in the first quarter of 2025. In addition, we will be eligible to receive additional contingent sales-based milestones payments related to ARCALYST. Huadong will also be obligated to pay us tiered percentage royalties on ARCALYST ranging from the low-to-mid teens on annual net sales in the Huadong Territory, subject to certain reductions tied to ARCALYST manufacturing costs and certain other customary reductions, with an aggregate minimum floor. Royalties will be payable on a country-by-country or region-by-region basis until the later of (i) 12 years after the first commercial sale of ARCALYST in such country or region in the Huadong Territory, (ii) the date of expiration of the last valid patent claim of our patent rights or any joint collaboration patent rights that covers ARCALYST in such country or region in the Huadong Territory, and (iii) the expiration of the last regulatory exclusivity for ARCALYST in such country or region in the Huadong Territory. We have recognized $0.2 million of revenue of the $32.0 million transaction price under the Huadong Collaboration Agreement as of June 30, 2026, and will recognize the remaining revenue as materials are shipped.

Previous wording

Selling, general and administrative expenses consist primarily of salaries and benefits, including share based compensation expense for personnel in selling, marketing, medical, executive, business development, finance, human

Current wording

Selling, general and administrative expenses consist primarily of salaries and benefits, including share based compensation expense for personnel in selling, marketing, medical, executive, business development, finance, human resources, legal and support personnel functions. Selling, general and administrative expenses also include external commercialization, marketing, and professional fees for legal, patent, and accounting services.

Previous wording

Our income is subject to the enacted United Kingdom statutory corporate tax rate. Our wholly owned United States subsidiaries, including Kiniksa Pharmaceuticals, Inc. (“Kiniksa US”), are subject to federal and state income taxes in the United States. Our wholly owned subsidiary Kiniksa Pharmaceuticals (UK), Ltd. (“Kiniksa UK”), its Swiss branch office, and Kiniksa UK’s wholly owned subsidiaries, including Kiniksa Pharmaceuticals, GmbH (“Kiniksa Switzerland”) are subject to taxation in their respective countries.

Current wording

Our income is subject to the enacted United Kingdom statutory corporate tax rate. Our wholly owned United States subsidiaries, including Kiniksa Pharmaceuticals Corp. (“Kiniksa US”), are subject to federal and state income taxes in the United States. Our wholly owned subsidiary Kiniksa Pharmaceuticals (UK), Ltd. (“Kiniksa UK”), its Swiss branch office, and Kiniksa UK’s wholly owned subsidiaries, including Kiniksa Pharmaceuticals, GmbH (“Kiniksa Switzerland”) are subject to taxation in their respective countries.

Previous wording

We recognized net revenue from the sale of ARCALYST of $214.3 million for the three months ended March 31, 2026, compared to $137.8 million for the three months ended March 31, 2025, an increase of $76.5 million. The increase in product revenue was driven primarily by an increase in patient enrollment.

Current wording

We recognized net revenue from the sale of ARCALYST of $243.6 million for the three months ended June 30, 2026, compared to $156.8 million for the three months ended June 30, 2025, an increase of $86.8 million. The increase in product revenue was driven primarily by an increase in patients on therapy.

Previous wording

We recognized cost of goods sold of $20.8 million for the three months ended March 31, 2026, compared to $17.9 million for the three months ended March 31,2025, an increase of $2.9 million. The increase in cost of goods sold relates primarily to the increase in sales of ARCALYST offset by favorable production variances.

Current wording

We recognized cost of goods sold of $23.6 million for the three months ended June 30, 2026, compared to $18.6 million for the three months ended June 30, 2025, an increase of $5.0 million. The increase in cost of goods sold relates primarily to the increase in sales of ARCALYST partially offset by favorable production variances.

Previous wording

Collaboration expenses were $75.6 million for the three months ended March 31, 2026, compared to $43.8 million for the three months ended March 31, 2025, an increase of $31.8 million. The increase of $31.8 million relates primarily to increased revenue from sales of ARCALYST.

Current wording

Collaboration expenses were $88.1 million for the three months ended June 30, 2026, compared to $52.4 million for the three months ended June 30, 2025, an increase of $35.7 million. The increase in collaboration expenses relates primarily to increased revenue from sales of ARCALYST.

Previous wording

Direct costs for our KPL-387 program were $16.2 million during the three months ended March 31, 2026, compared to $5.2 million during the three months ended March 31, 2025. The increase in expenses incurred primarily related to the enrollment and continuation of our Phase 2/3 clinical trial in recurrent pericarditis during the three months ended March 31, 2026, as compared to the Phase 1 clinical trial in normal healthy volunteers during the three months ended March 31, 2025.

Current wording

Direct costs for our KPL-387 program were $21.4 million during the three months ended June 30, 2026, compared to $8.5 million during the three months ended June 30, 2025. The increase in expenses incurred primarily related to the enrollment and continuation of our Phase 2/3 clinical trial in recurrent pericarditis and the start of the supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study during the three months ended June 30, 2026, as compared to the Phase 1 clinical trial in normal healthy volunteers and the start-up of our Phase 2/3 clinical trial during the three months ended June 30, 2025.

Previous wording

Direct costs for our KPL-1161 program were $1.0 million for the three months ended March 31, 2026, compared to $0.1 million during the three months ended March 31, 2025. For the three months ended March 31, 2026 and 2025, expenses incurred primarily related to pre-clinical development.

Current wording

Direct costs for our KPL-1161 program were $0.8 million for the three months ended June 30, 2026, compared to $0.4 million during the three months ended June 30, 2025. For the three months ended June 30, 2026 and 2025, expenses incurred primarily related to pre-clinical development.

Previous wording

Other income, net was $3.4 million and $2.3 million for the three months ended March 31, 2026 and March 31, 2025, respectively. The year-over-year increase was driven primarily by higher interest income generated by increased average holdings of cash, cash equivalents, and short-term investments.

Current wording

Other income, net was $4.0 million and $2.7 million for the three months ended June 30, 2026 and June 30, 2025, respectively. The year-over-year increase was driven primarily by higher interest income generated by increased average holdings of cash, cash equivalents, and short-term investments.

Previous wording

We recorded an income tax provision of $10.1 million and $7.0 million for the three months ended March 31, 2026 and March 31, 2025, respectively. The provision for income taxes was driven primarily by income earned in Switzerland, UK and the United States as well as uncertain tax positions offset in part by tax benefits related to share-based compensation, United States federal and state research and development credits (“R&D Credits”) and Foreign Derived Intangible Income (“FDII”) deduction.

Current wording

We recorded an income tax provision of $5.7 million and $5.0 million for the three months ended June 30, 2026 and June 30, 2025, respectively. The provision for income taxes was driven primarily by income earned in Switzerland, UK and the United States as well as uncertain tax positions offset in part by tax benefits related to share-based compensation, United States federal and state research and development credits (“R&D Credits”) and Foreign Derived Intangible Income (“FDII”) deduction. The increase in the provision for income taxes was driven primarily by an increase in taxable income partially offset by an increase in the tax benefits related to share-based compensation.

Previous wording

The direct costs for our abiprubart program were $0.1 million during the three months ended March 31, 2026, compared to $4.4 million during the three months ended March 31, 2025, a decrease of $4.3 million. For the three months ended March 31, 2025, expenses incurred primarily related to the close-out of our Phase 2b clinical trial in Sjögren’s Diseaseand $2.5 million of termination expenses associated with cancelled manufacturing agreements.

Current wording

The direct costs for our abiprubart program were $0.2 million during the six months ended June 30, 2026, compared to $5.0 million during the six months ended June 30, 2025, a decrease of $4.8 million. For the six months ended June 30, 2025, expenses incurred primarily related to the close-out of our Phase 2b clinical trial in Sjögren’s Disease and $2.5 million of termination expenses associated with cancelled manufacturing agreements.

Previous wording

Selling, general and administrative expenses were $61.2 million for the three months ended March 31, 2026, compared to $43.5 million for the three months ended March 31, 2025. The increase of $17.6 million was primarily due to an increase of $10.8 million in personnel-related costs largely attributable to an increase in headcount and an increase in sales and marketing expenses of $5.2 million largely attributable to increased promotional activities and the timing of free goods designation. Personnel-related costs for the three months ended March 31, 2026 and 2025 included share-based compensation of $7.9 million and $5.8 million, respectively.

Current wording

Selling, general and administrative expenses were $125.0 million for the six months ended June 30, 2026, compared to $90.4 million for the six months ended June 30, 2025. The increase of $34.6 million was primarily due to an increase of $20.4 million in personnel-related costs largely attributable to an increase in headcount and an increase in sales and marketing costs of $10.0 million largely attributable to promotional activities, including our direct-to-consumer advertising campaign. Personnel-related costs for the six months ended June 30, 2026 and 2025 included share-based compensation of $16.4 million and $12.4 million, respectively.

Previous wording

As of March 31, 2026, our principal source of liquidity was cash, cash equivalents and short-term investments, which totaled $468.1 million. Net income was $22.6 million and $8.5 million for the three months ended March 31, 2026 and 2025, respectively. We expect our cash balance and our expected cash inflows from operations to allow us to meet our current operating plan.

Current wording

As of June 30, 2026, our principal source of liquidity was cash, cash equivalents and short-term investments, which totaled $525.9 million. Net income was $48.0 million and $26.4 million for the six months ended June 30, 2026 and 2025, respectively. We expect our cash balance and our expected cash inflows from operations to allow us to meet our current operating plan.

Previous wording

Under various agreements with third parties, we have agreed to make milestone payments, pay royalties, pay annual maintenance fees and to meet due diligence requirements, each based upon specified events. Pursuant to the Regeneron Agreement, we have entered into a supply agreement with Regeneron to purchase both clinical and commercial product. We have entered into lease agreements for office and laboratory space, and vehicles, with total future lease payments of $9.9 million, $3.6 million of which are due within one year. In connection with our ongoing technology transfer of ARCALYST drug substance manufacturing, we have entered into a Master Services Agreement and a Product Specific Agreement with Samsung. Our commitments under such agreements, which includes the purchase of raw materials and related service fees, obligates us to minimum payments of $147.1 million, $59.8 million of which are due within one year. As of March 31, 2026, we have capitalized $21.1 million of production cost into inventory as semi-finished goods related to drug substance manufactured at Samsung. We have additionally entered into agreements with several CDMOs to provide us with preclinical and clinical trial materials for our non-ARCALYST assets, which obligate us to minimum payments of $10.2 million all of which are due within one year. We have long-term incentive plans for our employees that may result in cash award payments of $23.1 million, based upon the achievement of certain regulatory milestones, none of which are expected to be achieved in the next year.

Current wording

Under various agreements with third parties, we have agreed to make milestone payments, pay royalties, pay annual maintenance fees and to meet due diligence requirements, each based upon specified events. Pursuant to the Regeneron Agreement, we have entered into a supply agreement with Regeneron to purchase both clinical and commercial product. We have committed to minimum payments to Regeneron of $51.0 million, all of which are due within one year. We have entered into lease agreements for office and laboratory space, and vehicles, with total future lease payments of $9.6 million, $4.4 million of which are due within one year. We are also party to a Master Services Agreement and a Product Specific Agreement with Samsung related to the manufacture of ARCALYST drug substance. Our commitments under such agreements, which includes the purchase of raw materials and related service fees, obligates us to minimum payments of $140.4 million, $53.1 million of which are due within one year. We have additionally entered into agreements with several CDMOs to provide us with preclinical and clinical trial materials for our non-ARCALYST assets, which obligate us to minimum payments of $14.5 million all of which are due within one year. We have long-term incentive plans for our employees that may result in cash award payments of $24.9 million, based upon the achievement of certain regulatory milestones, none of which are expected to be achieved in the next year.

Previous wording

Net cash provided by operations was $50.2 million and $22.3 million for the three months ended March 31, 2026 and 2025, respectively. The increase in cash provided by operating activities is primarily due to an increase in net contribution from higher ARCALYST sales offset by a decrease in net cash received from licensing agreements of $20.0 million.

Current wording

Net cash provided by operations was $97.4 million and $50.4 million for the six months ended June 30, 2026 and 2025, respectively. The increase in cash provided by operating activities is primarily due to an increase in net contribution from higher ARCALYST sales.

Previous wording

Net cash used in investing activities was $31.9 million and $51.5 million for the three months ended March 31, 2026 and 2025, respectively. The increase in net cash used in investing activities was driven by managing our cash and short-term investment portfolio mix as we deployed higher levels of cash into Treasury Securities with longer-terms.

Current wording

Net cash used in investing activities was $105.5 million and $55.4 million for the six months ended June 30, 2026 and 2025, respectively. The increase in net cash used in investing activities was driven by managing our cash and short-term investment portfolio mix as we deployed higher levels of cash into Treasury Securities with longer-terms.

Previous wording

During the three months ended March 31, 2026 and 2025, net cash provided by financing activities was $6.1 million and $2.8 million, respectively, consisting of proceeds from the exercise of share options offset by payments in connection with ordinary shares tendered for employee tax obligations.

Current wording

During the six months ended June 30, 2026 and 2025, net cash provided by financing activities was $18.2 million and $13.5 million, respectively, consisting of proceeds from the exercise of share options offset by payments in connection with ordinary shares tendered for employee tax obligations.

Previous wording

We believe that our existing cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. The future viability of our company is dependent on our ability to fund our operations through sales of ARCALYST and/or raise additional capital, such as through debt or equity offerings, as needed. We anticipate that we may require additional capital if we choose to pursue collaboration, licensing or other strategic transactions. We expect to continue to incur significant expenses related to product manufacturing, including technology transfer costs, sales, marketing and distribution of ARCALYST. In addition, if we obtain regulatory approval for any of our current or future product candidates, pursue additional indications or additional territories for our products or any of our current or future product candidates, we expect to incur significant expenses related to product development and manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Current wording

We believe that our existing cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. The future viability of our company is dependent on our ability to fund our operations through sales of ARCALYST and/or raise additional capital, such as through debt or equity offerings, as needed. We anticipate that we may require additional capital if we choose to pursue collaboration, licensing or other strategic transactions. We expect to continue to incur significant expenses related to product manufacturing, sales, marketing and distribution of ARCALYST. In addition, if we obtain regulatory approval for any of our current or future product candidates, pursue additional indications or additional territories for our products or any of our current or future product candidates, we expect to incur significant expenses related to product development and manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Previous wording

Because of the numerous risks and uncertainties associated with research, development and commercialization of biologic products, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements may be impacted by a number of factors, including those described in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q.

Current wording

Because of the numerous risks and uncertainties associated with research, development and commercialization of biologic products, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements may be impacted by a number of factors, including those described in Part I, Item 1A of the Annual