Kiniksa Pharmaceuticals International, plc
FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2025
TABLE OF CONTENTS
| | | Page |
|---|
| PART I | | |
|---|
| | | |
|---|
| Item 1. Business | | 7 |
|---|
| | | |
|---|
| Item 1A. Risk Factors | | 43 |
|---|
| | | |
|---|
| Item 1B. Unresolved Staff Comments | | 93 |
|---|
| | | |
|---|
| Item 1C. Cybersecurity | | 93 |
|---|
| | | |
|---|
| Item 2. Properties | | 94 |
|---|
| | | |
|---|
| Item 3. Legal Proceedings | | 94 |
|---|
| | | |
|---|
| Item 4. Mine Safety Disclosures | | 94 |
|---|
| | | |
|---|
| | | |
|---|
| PART II | | |
|---|
| | | |
|---|
| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 95 |
|---|
| | | |
|---|
| Item 6. Reserved. | | 96 |
|---|
| | | |
|---|
| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 97 |
|---|
| | | |
|---|
| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | | 109 |
|---|
| | | |
|---|
| Item 8. Financial Statements and Supplementary Data | | 110 |
|---|
| | | |
|---|
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | 110 |
|---|
| | | |
|---|
| Item 9A. Controls and Procedures | | 110 |
|---|
| | | |
|---|
| Item 9B. Other Information | | 111 |
|---|
| | | |
|---|
| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | | 111 |
|---|
| | | |
|---|
| PART III | | |
|---|
| | | |
|---|
| Item 10. Directors, Executive Officers and Corporate Governance | | 112 |
|---|
| | | |
|---|
| Item 11. Executive Compensation | | 112 |
|---|
| | | |
|---|
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 112 |
|---|
| | | |
|---|
| Item 13. Certain Relationships and Related Transactions, and Director Independence | | 112 |
|---|
| | | |
|---|
| Item 14. Principal Accounting Fees and Services | | 112 |
|---|
| | | |
|---|
| PART IV | | |
|---|
| | | |
|---|
| Item 15. Exhibits and Financial Statement Schedules | | 113 |
|---|
| | | |
|---|
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report should be considered forward-looking statements, including statements regarding: our beliefs that KPL-387 will expand the recurrent pericarditis market and provide additional treatment options for patients; our beliefs about dosing and administration for our product candidates, including that KPL-387 has the potential for monthly subcutaneous self-administration in a liquid formulation and that KPL-1161 has the potential for quarterly subcutaneous dosing; our expectation to have data from the Phase 2 portion of our trial of KPL-387 in recurrent pericarditis in the second half of 2026 and that we plan to use the totality of the data to determine further development strategy; our plan to initiate a Phase 1 first-in-human clinical trial of KPL-1161 by the end of 2026; our plan to explore strategic alternatives for abiprubart; our belief that advancing KPL-387 through the clinic and into the market will further our mission of meeting patients’ needs; the results we expect to receive from our commercialization efforts; the incidence and prevalence for our target patient populations; our belief that each of our product candidates holds the potential to offer differentiated therapy to patients; planned indications for our products and product candidates; our expectations regarding the value we expect to receive/pay under our current license and collaboration agreements; the plans and strategy of our competitors; our expectations around the intellectual property protection we hope to receive for our products and product candidates; the intellectual property strategy we expect to employ to protect our portfolio; our plans to apply for patent term extensions; our predictions regarding future regulations and legislation; our planned commercial strategy; our plans to rely on third-parties, such as specialty pharmacies, contract research organizations (“CROs”) and contract development and manufacturing organizations (“CDMOs”); our relationships with payers; future supply for our products and product candidates; the timing and likelihood of success of our ongoing technology transfer of ARCALYST drug substance manufacturing; the expected impact of the United States’ tariffs on our operations, including that we do not expect that tariffs in their current state to have a material impact on our overall business, financial condition or results of operations; plans to conduct operations through one or more of our foreign subsidiaries; the ways in which we expect to incur expenses, including through any future clinical or commercialization efforts; our expectation that our cash balance and our expected cash inflows form operations will allow us to meet our current operating plan and 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; statements regarding our expected near-term expenditures and revenue; and other similar statements.
These statements 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.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “goal,” “design,” “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. The forward-looking statements in this Annual Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described under the sections in this Annual Report entitled “Summary Risk Factors”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Annual Report.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not place undue reliance on our forward-looking statements. Except as required by applicable law, we do not assume and specifically disclaim any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
SUMMARY RISK FACTORS
Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. “Risk Factors” in this Annual Report. You should carefully consider these risks and uncertainties when investing in our Class A ordinary shares. The principal risks and uncertainties affecting our business include the following:
| ● | we may not be able to continue to commercialize ARCALYST or be successful in commercializing any future products, potentially impacting our ability to generate revenue; |
| ● | we rely on a select network of third party specialty pharmacies to market and sell ARCALYST that may not meet our or our patients’ needs; |
| ● | successful commercialization of our products and product candidates, if approved, will depend in part on the extent to which third party payors, including governmental authorities and private health insurers, provide funding, establish and maintain favorable coverage and pricing policies and set adequate reimbursement levels; |
| ● | it may be difficult for us to realize the benefit of increasing the price of certain of our commercialized products; |
| ● | current and future healthcare legislation or executive or administrative action may have a material adverse effect on our business and results of operations; |
| ● | our business and operations are subject to extensive healthcare regulation and enforcement by various government entities, and our failure to adhere to these regulatory requirements could have a detrimental impact on our business; |
| ● | if we are unable to advance our product candidates in clinical development, obtain regulatory approval and pursue commercialization, or experience significant delays in doing so, our business may be significantly harmed; |
| ● | the incidence and prevalence for target patient populations of our products and product candidates have not been established with precision; if the market opportunities for our products and product candidates are smaller than we estimate, or any approval that we obtain is based on a narrower definition of our targeted patient population, our revenue and ability to achieve profitability may be materially adversely affected; |
| ● | clinical development of our product candidates is a lengthy and expensive process with uncertain timelines, costs and outcomes; |
| ● | we may encounter substantial delays in our preclinical studies and/or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; |
| ● | we may find it difficult to enroll participants in our clinical trials in a timely manner; |
| ● | interim, preliminary and “topline” data from our clinical trials that we announce or publish from time to time may change as more participant data become available and final data may differ from such interim, preliminary and “topline” data; |
| ● | we contract with third parties, including CDMOs to manufacture our commercial supply of ARCALYST and clinical supply of our product candidates and for certain research and development; this reliance on third parties increases the risk that we may not have sufficient quantities of ARCALYST or our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our research and development or commercialization efforts; |
| ● | we are conducting a technology transfer of the manufacturing process for ARCALYST drug substance from Regeneron Pharmaceuticals, Inc. (“Regeneron”) to Samsung Biologics Co., Ltd. (“Samsung”), and the analytical testing methods of ARCALYST drug substance and drug product to new contract testing labs (“CTLs”), which will be subject to significant risks and uncertainties; |
| ● | we rely, and expect to continue to rely, on third parties, including independent investigators and CROs to activate sites, conduct and otherwise support our research activities, preclinical studies, clinical trials and other trials for our product candidates; if these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval or commercialize our product candidates, and our business could be substantially harmed; |
| ● | if we are unable to adequately protect our proprietary technology or obtain and maintain patent protection for our technology and patents, if the scope of the patent protection obtained is not sufficiently broad or if the terms of our patents are insufficient to protect product candidates for an adequate amount of time, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our products may be materially impaired; |
| ● | licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach any of the agreements related to our product or product candidates, we could lose the ability to continue the development and commercialization of the related product or product candidate; |
| ● | we face significant competition, which may result in others discovering, developing or commercializing drugs before or more successfully than us; |
| ● | we may not successfully execute our growth strategy to identify, discover, develop, in-license or acquire additional product candidates or technologies, our strategy may not deliver anticipated results or we may refine or otherwise alter our growth strategy; |
| ● | we may seek to acquire businesses or undertake business combinations, collaborations or other strategic transactions that may not be successful or on favorable terms, if at all, and we may not realize the intended benefits of such transactions; |
| ● | we have entered into and may seek to enter into collaboration, licensing or other strategic transactions or arrangements to further develop, commercialize or otherwise attempt to realize value from one or more of our products and product candidates; such arrangements or transactions may not be successful or on favorable terms, which could adversely affect our ability to develop, commercialize or attempt to realize value from our products and product candidates; |
| ● | we may be adversely affected by continuing geopolitical tensions, including the introduction of tariffs or reciprocal tariffs that may be imposed by the United States and its global trading partners that could collectively cause economic uncertainty and increased costs to product development and manufacturing; |
| ● | the concentration of ownership of the voting power of our ordinary shares, including our Class B ordinary shares, and conversion rights of the holders of our Class A1 and Class B1 ordinary shares, which are held entirely by entities affiliated with certain of our directors, may prevent new investors from influencing significant corporate decisions and may have an adverse effect on the price of our Class A ordinary shares; and |
| ● | the rights afforded to our shareholders are governed by English law; not all rights available to shareholders under United States law will be available to holders of our ordinary shares. |
Industry and other data
Unless otherwise indicated, certain industry data and market data included in this Annual Report were obtained from independent third party surveys, market research, publicly available information, reports of governmental agencies and industry publications and surveys. All of the market data used in this Annual Report involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We believe that the information from these industry publications and surveys included in this Annual Report is reliable.
ARCALYST® is a registered trademark of Regeneron. Solely for convenience, trademarks, service marks and trade names referred to in this Annual Report may be listed without identifying symbols.
