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Kiniksa Pharmaceuticals International, plc

In its 2026 annual report the company says: “We are a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Our portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation.”5 Its shares trade on Nasdaq under the symbol KNSA.1

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Last updated Oct 21, 2026.

Overview

$677.6MRevenue, fiscal 20252
$59.0MNet income, fiscal 20252

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  • TickerKNSA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • Business address105 Piccadilly, Second Floor, London, W1J 7Nj3
  • Filer categoryLarge accelerated filer3

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We are a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Our portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

11.4%Operating margin2
8.7%Net margin2
60.1%Revenue growth, 20252
10.4%Return on equity2
$136.4MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue11¢$77.7M
  • Research and development14¢$96.9M
  • Selling, general and admin29¢$196.3M
  • Other costs32¢$217.9M
  • Income tax4¢$29.9M
  • Profit9¢$59.0M

Out of $677.6M in revenue.2

Where each dollar of operating cash went, fiscal 2025

  • Capital spending1¢$1.6M
  • Kept or used elsewhere99¢$136.4M

Out of $138.0M of cash from operations.2

Financial statements

Revenue672$677.6M in 2025+1658% since 2021
0$200.0M$400.0M$600.0M$800.0M2021: $38.5M$38.5M20212022: $220.2M$220.2M2022+471%2023: $270.3M$270.3M2023+23%2024: $423.2M$423.2M2024+57%2025: $677.6M$677.6M2025+60%
Operating income8910672$77.2M in 2025
-$200.0M-$100.0M0$100.0M2018: -$108.2M-$108.2M20182019: -$170.0M-$170.0M2019+57%2020: -$157.4M-$157.4M2020−7%2021: -$156.6M-$156.6M2021−0%2022: $9.8M$9.8M20222023: -$25.2M-$25.2M20232024: -$45.6M-$45.6M2024+81%2025: $77.2M$77.2M2025
Net income8910672$59.0M in 2025
-$200.0M-$100.0M0$100.0M$200.0M2018: -$103.2M-$103.2M20182019: -$161.9M-$161.9M2019+57%2020: -$161.4M-$161.4M2020−0%2021: -$157.9M-$157.9M2021−2%2022: $183.4M$183.4M20222023: $14.1M$14.1M2023−92%2024: -$43.2M-$43.2M20242025: $59.0M$59.0M2025

Every line of the income statement as filed: the last 3 fiscal years, latest first.2

Period ending2025-12-312024-12-312023-12-31
Revenue$677.6M$423.2M$270.3M
Cost of goods sold$77.7M$60.9M$33.4M
Collaboration expenses$229.5M$128.3M$56.5M
Research and development$96.9M$111.6M$76.1M
Selling, general and administrative$196.3M$168.0M$129.4M
Total operating expenses$600.3M$468.9M$295.5M
Income (loss) from operations$77.2M-$45.6M-$25.2M
Other income, net$11.6M$9.5M$8.5M
Income (loss) before income taxes$88.9M-$36.2M-$16.7M
Benefit (provision) for income taxes-$29.9M-$7.0M$30.7M
Net income (loss)$59.0M-$43.2M$14.1M
Net income (loss) per share attributable to ordinary shareholders, basic$0.80-$0.60$0.20
Net income (loss) per share attributable to ordinary shareholders, diluted$0.75-$0.60$0.20
Weighted average ordinary shares outstanding, basic74.2M shares71.4M shares70.1M shares
Weighted average ordinary shares outstanding, diluted79.0M shares71.4M shares71.9M shares
Unrealized gain (loss) on short-term investments and currency translation adjustments, net of tax$138.0K-$169.0K-$38.0K
Total other comprehensive income (loss)$138.0K-$169.0K-$38.0K
Total comprehensive income (loss)$59.1M-$43.4M$14.0M

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Corporate structure

Kiniksa Pharmaceuticals International, plc sits at the top of its group. 6 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Kiniksa Pharmaceuticals International, plc

  • BlackRock Filed SCHEDULE 13G on Kiniksa Pharmaceuticals International, plc, latest Jul 29, 2026 (14 filings since Nov 10, 2021)
  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13D/A on Kiniksa Pharmaceuticals International, plc, latest May 26, 2026 (2 filings since Oct 8, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Kiniksa Pharmaceuticals International, plc, latest May 6, 2026 (2 filings since Mar 6, 2026)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Kiniksa Pharmaceuticals International, plc, latest Mar 27, 2026 (5 filings since Feb 10, 2022)
  • Rubric Capital Management LP Filed SCHEDULE 13G/A on Kiniksa Pharmaceuticals International, plc, latest Feb 13, 2026 (5 filings since Feb 12, 2024)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Kiniksa Pharmaceuticals International, plc, latest Apr 4, 2025
  • Fairmount Funds Management LLC Filed SCHEDULE 13G/A on Kiniksa Pharmaceuticals International, plc, latest Feb 14, 2025 (4 filings since Aug 10, 2023)
  • HHLR ADVISORS, LTD. Filed SC 13G/A on Kiniksa Pharmaceuticals International, plc, latest Nov 14, 2024 (4 filings since Feb 14, 2023)
  • PICTET ASSET MANAGEMENT SA Filed SC 13G on Kiniksa Pharmaceuticals International, plc, latest Feb 3, 2023 (2 filings since Feb 10, 2022)
  • Ameriprise Financial Filed SC 13G/A on Kiniksa Pharmaceuticals International, plc, latest Feb 14, 2022
  • Kiniksa Pharmaceuticals International, plc
    • Kiniksa Pharmaceuticals (France) SARL Subsidiary · France
    • Kiniksa Pharmaceuticals (Germany) GmbH Subsidiary · Germany
    • Kiniksa Pharmaceuticals (UK), Ltd. Subsidiary · United Kingdom
    • Kiniksa Pharmaceuticals Corp. Subsidiary · Delaware, United States
    • Primatope Therapeutics, Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Kiniksa Pharmaceuticals International, plc reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$9.2M2 Dec 31, 2025$8.9M2 Dec 31, 2024+3.6%
Accumulated depreciation$7.2M2 Dec 31, 2025$8.2M2 Dec 31, 2024−11.8%
Property and equipment, net$1.9M2 Dec 31, 2025$662.0K2 Dec 31, 2024+193.5%
Operating-lease assets (leased space)$9.8M2 Dec 31, 2025$10.4M2 Dec 31, 2024−5.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$165.6M2 Dec 31, 2025$183.6M2 Dec 31, 2024−9.8%
Marketable securities, current$248.5M2 Dec 31, 2025$60.0M2 Dec 31, 2024+313.8%
Debt securities available for sale$248.5M2 Dec 31, 2025$60.0M2 Dec 31, 2024+313.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$20.0M2 Dec 31, 2025$20.0M2 Dec 31, 20240%
Accumulated amortization$4.8M2 Dec 31, 2025$3.8M2 Dec 31, 2024+26.7%
Finite-lived intangibles, net$15.2M2 Dec 31, 2025$16.2M2 Dec 31, 2024−6.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$54.9M2 Dec 31, 2025$26.4M2 Dec 31, 2024+108.2%
Raw materials$10.0M2 Dec 31, 2025$10.0M2 Dec 31, 20240%
Work in process$29.4M2 Dec 31, 2025$18.3M7 Dec 31, 2023+61.0%
Finished goods$20.6M2 Dec 31, 2025$21.2M2 Dec 31, 2024−3.3%

Properties, in its own words

Our executive headquarters are located in Lexington, Massachusetts, where we have leased office and laboratory space, under a lease that expires in August 2028. We have also leased office space in London, UK, Zug, Switzerland and San Diego, California. These spaces include commercial and logistical operations, as well as office space to support our research and development operations.

Item 2 of the 10-K filed Feb 24, 2026.5

Leadership

Who has led Kiniksa Pharmaceuticals International, plc, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Sanj K. Patel2018–now

Chair

  1. Sanj K. Patel2018–now

President

  1. Stephen F. Mahoney2018–2019

Chief financial officer

  1. Chris Heberlig2018–2019
  2. Mark Ragosa2020–now

Chief operating officer

  1. Stephen F. Mahoney2018–2019
  2. Eben Tessari2022–2026
  3. Ross Moat2026–now
20202025
Board members and other officers (19)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Kiniksa Pharmaceuticals (France) SARL France4
  • Kiniksa Pharmaceuticals (Germany) GmbH Germany4
  • Kiniksa Pharmaceuticals (UK), Ltd. United Kingdom4
  • Kiniksa Pharmaceuticals Corp. Delaware4
  • Kiniksa Pharmaceuticals, GmbH Switzerland4
  • Primatope Therapeutics, Inc. Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Kiniksa Pharmaceuticals, Ltd.Feb 27, 2018 to Jun 28, 20243

Timeline

  1. Jul 28, 20268-K Results of operations40
  2. May 29, 20268-K Shareholder vote41
  3. May 26, 20268-K Entered a material agreement42
  4. May 1, 20268-K Executive or director change43
  5. Apr 28, 20268-K Results of operations44
  6. Feb 24, 20268-K Results of operations45
  7. Jan 14, 20268-K Executive or director change46
  8. Jan 12, 20268-K Results of operations47
  9. Oct 28, 20258-K Results of operations48
  10. Sep 3, 20258-K Regulation FD disclosure49
  11. Jul 29, 20258-K Results of operations50
  12. Jun 5, 20258-K Regulation FD disclosure51
  13. May 23, 2018New chief executive Sanj K. Patel becomes CEO17

Calendar

Coming up

  1. Oct 27, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.23 a share, on Oct 28, 2025.52

When it reported results

  1. Jul 28, 2026Reported quarterly or annual results40
  2. Apr 28, 2026Reported quarterly or annual results44
  3. Feb 24, 2026Reported quarterly or annual results45
  4. Jan 12, 2026Reported quarterly or annual results47
  5. Oct 28, 2025Reported quarterly or annual results48
  6. Jul 29, 2025Reported quarterly or annual results50
  7. Apr 29, 2025Reported quarterly or annual results53
  8. Feb 25, 2025Reported quarterly or annual results54

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

509 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 44 major events, 262 insider forms, 40 large holders, 143 other. The latest 20:

  1. Sep 3, 2026144 EDGAR
  2. Sep 3, 20264 EDGAR
  3. Sep 3, 20264 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Sep 3, 20264 EDGAR
  6. Sep 3, 20264 EDGAR
  7. Sep 3, 20264 EDGAR
  8. Aug 21, 20264 EDGAR
  9. Aug 4, 20264 EDGAR
  10. Jul 31, 20264 EDGAR
  11. Jul 29, 2026SCHEDULE 13G EDGAR
  12. Jul 29, 2026144 EDGAR
  13. Jul 29, 2026144 EDGAR
  14. Jul 28, 20268-K EDGAR
  15. Jul 28, 202610-Q EDGAR
  16. Jul 6, 20264 EDGAR
  17. Jul 6, 20263 EDGAR
  18. Jun 2, 20264 EDGAR
  19. Jun 2, 20264 EDGAR
  20. Jun 2, 20264 EDGAR

The 509 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

123 open-market trades by officers, directors and large owners since October 2021: 0 buys and 123 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 3, 2026Megna Michael RCHIEF ACCOUNTING OFFICERSale4,600$80.30$369.4KForm 4
Jul 29, 2026Cole G BradleyDirectorSale3,673$81.43$299.1KForm 4
May 1, 2026Paolini John F.CHIEF MEDICAL OFFICERSale58,424$53.71$3.1MForm 4
May 1, 2026Patel Sanj KCHAIRMAN & CEOSale48,565$54.02$2.6MForm 4
Apr 30, 2026Patel Sanj KCHAIRMAN & CEOSale2,141$54.01$115.6KForm 4
Apr 29, 2026Patel Sanj KCHAIRMAN & CEOSale22,544$54.01$1.2MForm 4
Apr 28, 2026Patel Sanj KCHAIRMAN & CEOSale483,654$51.86$25.1MForm 4
Apr 28, 2026Quart Barry DDirectorSale13,099$50.10$656.3KForm 4
Apr 9, 2026Moat RossCHIEF OPERATING OFFICERSale1,703$46.69$79.5KForm 4
Apr 9, 2026Megna Michael RCHIEF ACCOUNTING OFFICERSale6,625$46.69$309.3KForm 4
Apr 6, 2026Moat RossCHIEF OPERATING OFFICERSale2,367$48.58$115.0KForm 4
Apr 6, 2026Patel Sanj KCHAIRMAN & CEOSale7,278$50.01$364.0KForm 4
Apr 6, 2026Quart Barry DDirectorSale6,901$50.00$345.1KForm 4
Mar 9, 2026Ragosa MarkCHIEF FINANCIAL OFFICERSale36,722$45.92$1.7MForm 4
Mar 2, 2026Paolini John F.CHIEF MEDICAL OFFICERSale40,000$44.82$1.8MForm 4
Feb 12, 2026Quart Barry DDirectorSale2,690$45.00$121.0KForm 4
Feb 10, 2026Quart Barry DDirectorSale110$45.00$5.0KForm 4
Feb 9, 2026Ragosa MarkCHIEF FINANCIAL OFFICERSale17,845$43.28$772.3KForm 4
Feb 4, 2026Quart Barry DDirectorSale2,602$45.02$117.1KForm 4
Feb 3, 2026Quart Barry DDirectorSale12,528$45.27$567.1KForm 4

All 123 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Total$7.5M65
2025Sanj K. Patel56$6.1M65
2025Non-Executive Director Total$1.4M65
2025Richard S. Levy68$211.5K65
2025Felix J. Baker$175.5K65
2025Barry D. Quart69$159.5K65
2025Thomas R. Malley57$156.5K65
2025Kimberly J. Popovits67$151.5K65
2025Stephen R. Biggar$150.5K65
2025G Bradley Cole70$141.5K65
2025Tracey L. McCain58$141.5K65
2025M. Cantey Boyd46$140.5K65
2024Sanj K. Patel56$2.8M65
2024Non-Executive Director Total$1.2M65
2024Richard S. Levy68$205.9K65
2024Felix J. Baker$153.9K65
2024Thomas R. Malley57$128.1K65
2024M. Cantey Boyd46$127.4K65
2024Ross Moat45$127.1K65
2024Barry D. Quart69$125.7K65
2024Mark Ragosa51$119.3K65
2024Stephen R. Biggar$118.1K65
2024Kimberly J. Popovits67$112.2K65
2024G Bradley Cole70$111.5K65
2024Tracey L. McCain58$111.5K65
2024Michael Megna55$90.9K65

SEC filer profile

How Kiniksa Pharmaceuticals International, plc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARKiniksa Pharmaceuticals International, plc1
  • CIK0001730430
  • Employer ID (EIN)98-17955785
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inEngland and Wales5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address105 Piccadilly, Second Floor, London, W1J 7NJ, United Kingdom1
  • Phone78143191001
  • Shares outstanding76,535,377 Common Stock shares; 45,900,637 Common Class A shares; 1,795,158 Common Class B shares; 12,781,964 Common Class A1 shares; 16,057,618 Common Class B1 shares as of Feb 20, 20265
  • Public float$1.1B as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 27, 20181
  • Filings763 in all: 4 (353), 144 (88), 8-K (82), SC 13G/A (29), 10-Q (25), 3 (24), SC 13G (18), CORRESP (15)1
    All 43 form types

    DEFA14A (13), UPLOAD (12), EFFECT (10), SCHEDULE 13G/A (9), 10-K (8), DEF 14A (8), S-8 (8), S-3 (6), S-8 POS (6), SC 13D/A (5), 424B5 (4), ARS (4), CT ORDER (3), SCHEDULE 13G (3), 424B4 (2), D/A (2), DRS (2), FWP (2), POS AM (2), PRE 14A (2), S-1 (2), S-1/A (2), SEC STAFF LETTER (2), 15-15D (1), 15-15D/A (1), 5 (1), 8-A12B (1), 8-K12B (1), CERT (1), D (1), DRS/A (1), DRSLTR (1), S-1MEF (1), SC 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Jul 28, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Jul 28, 2026

Securities registered for trading

ClassSymbolExchange
Class A Ordinary SharesKNSANasdaq

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Kiniksa Pharmaceuticals International, plc names in Item 1A of its 10-K filed Feb 24, 2026: 62 risks under these headings, as written.5

  • Risks Related to Commercialization
  • We may not be able to continue to commercialize ARCALYST or be successful in commercializing any future products, potentially impairing the commercial potential for our current and future products to generate any 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.
  • The successful commercialization of our current and future products, if any, 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.
  • The incidence and prevalence for target patient populations of our products or product candidates have not been established with precision. If the market opportunities for our products and product candidates are smaller than we estimate, or if any approval that we obtain is based on a narrower definition of our targeted patient population, our revenue and ability to sustain profitability may be materially adversely affected.
  • Evolving health policy and associated legislative changes related to coverage and reimbursement aimed at lowering healthcare expenditures could impact the commercialization of our product candidates. Pharmaceutical pricing has been, and likely will continue to be, a central component of these efforts.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of ARCALYST and any product candidates that we may develop, if approved.
  • Any future growth outside of the United States would be subject to additional regulatory burdens and other risks and uncertainties.
  • Our business and operations are subject to extensive healthcare regulation and enforcement by various government entities, and our failure to strictly adhere to these regulatory requirements could have a detrimental impact on our business.
  • Risks Related to Product Development
  • If we are unable to advance our product candidates in clinical development and obtain regulatory approval, or experience significant delays in doing so, our business may be significantly harmed.
The other 52 risks
  • Clinical drug development is a lengthy and expensive process with uncertain timelines and outcomes. We may encounter substantial delays in our clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. We may therefore be unable to obtain required regulatory approvals and be unable to successfully commercialize our product candidates on a timely basis, if at all.
  • We may find it difficult to enroll participants in our clinical trials in a timely manner given the limited number of patients who have the diseases for which our product candidates are being studied, our particular enrollment criteria or competing clinical studies in the same patient population.
  • Undesirable side effects or adverse reactions caused by any of our product candidates may be identified that could delay or prevent their marketing approval or limit their use.
  • Interim, preliminary and “top-line” data from our clinical trials may differ from final data.
  • Risks Related to Marketing Approval and Regulatory Matters
  • Regulatory approval processes are lengthy, time consuming and inherently unpredictable. If we cannot obtain, or if there are delays in obtaining, required regulatory approvals for our current or future product candidates or if we fail or otherwise cease to advance their development, we will be delayed in commercializing, or will not be able to commercialize, our current or future product candidates.
  • Our products, current product candidates and any of our future product candidates regulated as biologics in the United States may face biosimilar competition sooner than anticipated.
  • If we obtain marketing authorization of our current or future product candidates in a major pharmaceutical market, we may not seek or obtain approval or commercialize our current products or product candidates in other markets, which would limit our ability to realize their full market potential.
  • We may seek Orphan Drug designation for our product candidates in the United States, as well as for any of our product candidates in the EU, and we may be unsuccessful, or may be unable to maintain the benefits associated with Orphan Drug designation, including the potential for market exclusivity, for any product candidate for which we obtain Orphan Drug designation.
  • We may seek Breakthrough Therapy designation or Fast Track designation by the FDA, for one or more of our product candidates, which we may not receive. Such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • We may seek a PRIME designation from the EMA, a conditional MA or other designations, schemes or tools for one or more of our product candidates, which we may not receive. Such designations may not lead to a faster development or regulatory review or approval process and do not increase the likelihood that our product candidates will receive marketing authorization.
  • We face substantial uncertainty regarding potential regulatory developments in the United States that may adversely affect our business.
  • Risks Related to Manufacturing and Our Reliance on Third Parties
  • We contract with third parties for manufacturing our commercial supply of ARCALYST and clinical supply for our product candidates and for certain research and other preclinical 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 with respect to the manufacturing process of ARCALYST drug substance from Regeneron to Samsung and the analytical testing methods of ARCALYST drug substance and drug product to new CTLs. Such technology transfer will be subject to significant risks and uncertainties.
  • The third parties upon whom we rely for the supply of our products and product candidates are our sole source of supply, and the loss of any of these suppliers could significantly harm our business or the business of our partners.
  • Our business involves the use of hazardous materials, and we and our third party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • We rely, and expect to continue to rely, on third parties to 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 for or commercialize our product candidates, and our business could be substantially harmed.
  • Risks Related to Competition, Executing our Strategy and Managing Growth
  • We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
  • We may not be successful in executing our growth strategy to identify, discover, develop, in-license or acquire additional product candidates or technologies, and our growth strategy may not deliver the 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 which 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 our products and product candidates, and any such transactions or arrangements that we enter into may not be successful or be on favorable terms, which could adversely affect our ability to develop, commercialize or attempt to realize value from our products and product candidates.
  • Risks Related to Intellectual Property
  • If we are unable to adequately protect our proprietary technology or obtain and maintain patent protection for our technology and products, if the scope of the patent protection obtained is not sufficiently broad or if the terms of our patents are insufficient to protect our 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 technology and 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. Additionally, our current licensing and acquisition agreements contain limitations and restrictions that could limit or adversely affect our ability to develop and commercialize other products in the future.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to effectively enforce our intellectual property rights throughout the world.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product or our current or future product candidates.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • If our trademarks and trade names are not adequately protected, then we may be unable to build name recognition in our markets of interest and our business may be adversely affected.
  • General Risk Factors
  • We have a history of operating losses and may require substantial additional financing in the future.
  • If we fail to comply with reporting and payment obligations under the MDRP or other governmental pricing and price reporting programs, we could be subject to additional reimbursement requirements and penalties or sanctions, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Current and future healthcare legislation or executive or administrative action may have a material adverse effect on our business and results of operations.
  • Our information technology systems, or those of our third party CDMOs, CROs, specialty pharmacies, third party logistics providers and other contractors, consultants and service providers, may fail or suffer cyberattacks or security incidents, which could result in a material disruption of our or such third party’s business or operations, impede our development programs for our product candidates or materially impact our ability to commercialize our products.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition.
  • Our future success depends on our ability to retain key executives and senior management; attract, retain and motivate qualified personnel; and implement succession planning efforts to ensure our long-term success.
  • Our employees, principal investigators, CROs, consultants and other third party service providers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Changes in United States trade policy, including tariffs imposed by the United States and any reciprocal tariffs imposed in response, could materially impact our business and results of operations.
  • Unfavorable global economic or operational conditions could adversely affect our business, financial condition or results of operations.
  • Climate change, and related regulation, may result in increased costs or otherwise negatively impact our operations and harm our business.
  • Risks Related to Ownership of Our Ordinary Shares
  • The concentration of ownership of our Class B ordinary shares among our senior management, and the conversion rights of our Class A1 and B1 ordinary shares, which are held entirely by entities affiliated with certain of our directors, means that certain matters submitted to our shareholders for approval may be influenced by such persons, which may have an adverse effect on the price of our Class A ordinary shares and may result in our Class A ordinary shares being undervalued.
  • The price of our Class A ordinary shares may be volatile and fluctuate substantially, which could result in substantial losses for holders of our Class A ordinary shares.
  • If securities or industry analysts cease publishing about us or publish unfavorable research or reports about us, our business or our market, our share price and trading volume could decline.
  • Sales of a number of our Class A ordinary shares in the public market, including Class A ordinary shares issuable upon conversion of our Class B, Class A1 and Class B1 ordinary shares, could cause the share price of our Class A ordinary shares to fall.
  • We have anti-takeover provisions in our articles of association that may discourage a change of control.
  • Because we do not anticipate paying any cash dividends on our shares in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our shareholders.
  • Risks Related to Our Jurisdiction of Incorporation and Certain Tax Risks
  • As a result of increased shareholder voting requirements in the UK relative to the United States, we will have less flexibility with respect to our ability to issue new shares.
  • 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.
  • Investors in the United States may find it difficult to enforce their civil liabilities against us.
  • We may become subject to unanticipated tax liabilities, including liabilities arising from the reallocation of our taxable income among our subsidiaries.
  • Changes and uncertainties in the tax system in the countries in which we have operations, could materially adversely affect our financial condition and results of operations, and reduce net returns to our shareholders.
  • We may be treated as a passive foreign investment company (“PFIC”) for United States federal income tax purposes. If we were to be classified a PFIC, this could result in adverse United States federal income tax consequences to United States Holders.
  • If a United States Holder is treated as owning at least 10% of our shares, by vote or by value, such holder may be subject to adverse United States federal income tax consequences.

Legal proceedings

We are not party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.5

Sources

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