Kiniksa Pharmaceuticals, Ltd., a biopharmaceutical company, focuses on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical needs worldwide. Its product candidates include ARCALYST, an interleukin-1alpha and interleukin-1beta, for the treatment of recurrent pericarditis, which is an inflammatory cardiovascular disease; Mavrilimumab, a monoclonal antibody inhibitor that completed Phase II clinical trials for the treatment of giant cell arteritis; Vixarelimab, a monoclonal antibody, which is in Phase 2a clinical trial for the treatment of prurigo nodularis, a chronic inflammatory skin condition; and KPL-404, a monoclonal antibody inhibitor of the CD40- CD154 interaction, a T-cell co-stimulatory signal critical for B-cell maturation, immunoglobulin class switching, and type 1 immune response. Kiniksa Pharmaceuticals, Ltd. was incorporated in 2015 and is based in Hamilton, Bermuda.
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1. Alexion Pharmaceuticals for rare inflammatory diseases, but on a smaller scale.
2. A specialized biotech company akin to Vertex Pharmaceuticals, focused on autoimmune and inflammatory rare diseases.
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ARCALYST (rilonacept): An interleukin-1 (IL-1) blocker approved for treating recurrent pericarditis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of IL-1 Receptor Antagonist (DIRA).
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Vixarelimab: A fully human monoclonal antibody in clinical development designed to inhibit oncostatin M (OSM) for the potential treatment of prurigo nodularis and other inflammatory diseases.
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KPL-404: A monoclonal antibody in clinical development that targets the CD40 ligand (CD40L) for the potential treatment of various autoimmune diseases.
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Kiniksa Pharmaceuticals International (KNSA) sells primarily to other companies within the pharmaceutical supply chain, not directly to individuals.
According to Kiniksa's latest Annual Report on Form 10-K for the year ended December 31, 2023, the company's major customers are primarily **specialty distributors** and **specialty pharmacies** in the United States.
Kiniksa's 10-K filing explicitly states a significant customer concentration:
"For the years ended December 31, 2023, 2022 and 2021, **two customers accounted for 90%, 88% and 88% of our net product revenue, respectively.**"
However, Kiniksa Pharmaceuticals International does not publicly disclose the specific names of these two major customers in its SEC filings or other public investor communications. Therefore, while the company relies heavily on two specific entities, their names are not identified by KNSA.
Based on the publicly available information, the categories of customers that KNSA serves are:
- Specialty Distributors: These companies handle the distribution of complex, high-cost, and often temperature-sensitive pharmaceutical products like those developed by Kiniksa. They serve as intermediaries between the pharmaceutical manufacturer and the dispensing pharmacies or healthcare providers.
- Specialty Pharmacies: These pharmacies focus on dispensing and managing specialty medications, which often require special handling, administration, and patient education. They provide comprehensive support to patients taking these complex drugs.
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Kiniksa Pharmaceuticals International (KNSA)
Sanj K. Patel, CEO & Chairman of the Board
Sanj K. Patel is the CEO and Chairman of the Board of Kiniksa Pharmaceuticals, which he took public on the NASDAQ Global Market in May 2018. He brings over 30 years of experience in the biopharmaceutical industry. Prior to founding Kiniksa, Mr. Patel founded Synageva BioPharma in 2008, where he designed and initiated its lead program, Kanuma®, for lysosomal acid lipase deficiency. He took Synageva public on the NASDAQ Global Market in November 2011 and raised over $1 billion in capital. In June 2015, Synageva was sold to Alexion Pharmaceuticals for $9.7 billion, which was noted as the highest premium ever paid for a biotech company valued over $5 billion. Before Synageva, Mr. Patel spent almost a decade as an executive at Genzyme Corporation, holding senior leadership roles in sales, marketing, and clinical research, and was instrumental in the commercialization of several treatments, including leading the Fabrazyme® clinical operations team to FDA approval.
Mark Ragosa, Executive Vice President, Chief Financial Officer
Mark Ragosa joined Kiniksa in 2018 and became Chief Financial Officer in 2021, overseeing finance, investor relations, corporate communications, human resources, quality, and information technology functions. He has over 25 years of experience in the financial services and biopharmaceutical industries. Prior to joining Kiniksa, he was a member of the investor relations team at Ironwood Pharmaceuticals. Earlier in his career, Mr. Ragosa held roles of increasing responsibility within the equities divisions of Goldman Sachs, Morgan Stanley, and Bank of America Securities, where he facilitated capital raises for private and public companies and conducted financial analyses. He is a Chartered Financial Analyst.
Ross Moat, Executive Vice President, Chief Corporate & Commercial Officer
Ross Moat joined Kiniksa in 2019 and serves as Executive Vice President, Chief Corporate & Commercial Officer, bringing over 22 years of experience in biopharmaceuticals. He has led sales, marketing, commercial operations, market access, and diagnostic functions within orphan and ultra-orphan disease fields. Before Kiniksa, Mr. Moat played a lead role in the successful commercialization efforts for innovative gene therapies at Novartis Gene Therapies and Spark Therapeutics. He also served as the metabolic franchise commercial head at Alexion following its acquisition of Synageva, where he was previously General Manager for the UK & Ireland.
Eben Tessari, Executive Vice President, Chief Operating Officer
Eben Tessari joined Kiniksa at its founding in 2015. He was initially Chief Business Officer, overseeing long-range strategic planning, forecasting, decision analysis, business development, licensing, valuation, and new product strategy. In January 2022, he was promoted to Chief Operating Officer, where he oversees functional leadership teams in business development, program management, clinical development, manufacturing, and research. Before Kiniksa, he was Senior Director and Head of Business Development at Synageva BioPharma.
Dr. John F. Paolini, M.D., Executive Vice President and Chief Medical Officer
Dr. John F. Paolini serves as the Executive Vice President and Chief Medical Officer at Kiniksa Pharmaceuticals. His role involves guiding the clinical development of the company's therapies.
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Kiniksa Pharmaceuticals International (KNSA) faces several key risks inherent to the biopharmaceutical industry. The most significant risks include:
1. Dependence on Key Product Candidates and Overreliance on Arcalyst
Kiniksa Pharmaceuticals International is notably dependent on a limited number of product candidates, particularly its lead therapy, Arcalyst. This reliance poses a significant risk, as any setbacks in clinical trials, regulatory approvals, or the emergence of competitive or regulatory pressures concerning Arcalyst could materially impact the company's revenue streams and future prospects. While strong sales of Arcalyst have contributed to recent financial performance, limited diversification means that any adverse changes in Arcalyst's competitive or regulatory environment could quickly affect revenue and earnings growth.
2. Regulatory and Development Risks
The path to bringing new pharmaceuticals to market is fraught with complex regulatory hurdles and development risks. Kiniksa must navigate intricate approval processes and potential delays, which could impact its ability to capitalize on its product pipeline. Risks include delays or difficulties in patient enrollment for clinical trials, challenges in completing trials as originally designed, and the potential for regulatory authorities to delay or deny approval of product candidates or require additional data. The need for continuous investment in research to stay ahead in the fast-paced industry can also strain financial resources.
3. Competitive Market Pressures
The biopharmaceutical industry is highly competitive, with numerous players vying for market share. Kiniksa Pharmaceuticals International faces the ongoing challenge of maintaining its competitive edge amidst rapid technological advancements and aggressive market strategies from competitors. Increased competition could intensify for Arcalyst, potentially affecting its market penetration and pricing power. Sustaining growth and market position necessitates continuous innovation and strategic partnerships.
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The ongoing Phase 3 clinical development of AbbVie's Rinvoq (upadacitinib) for Giant Cell Arteritis (GCA) presents a clear emerging threat. Rinvoq is an oral JAK inhibitor that, if approved, would compete directly in a market that Kiniksa is targeting with its investigational anti-GM-CSF receptor antibody, mavrilimumab. The potential approval of a highly effective oral therapy like Rinvoq could significantly impact the market potential and commercial viability of mavrilimumab in GCA.
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Kiniksa Pharmaceuticals International (KNSA) focuses on developing and commercializing therapeutic medicines for debilitating diseases with significant unmet medical needs. Their main products and pipeline candidates, along with their addressable markets, are as follows:
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ARCALYST (rilonacept): Approved for recurrent pericarditis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of the Interleukin-1 Receptor Antagonist (DIRA) in the U.S..
- For **recurrent pericarditis**, the target addressable market in the U.S. is estimated to be 14,000 multiple-recurrence patients.
- The global recurrent pericarditis market is estimated to be valued at approximately USD 585.63 billion in 2025 and is projected to reach USD 851.90 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.5% from 2025 to 2032.
- The pericarditis drugs market (which includes recurrent pericarditis) in the U.S. reached USD 1.8 billion in 2024. The global pericarditis market size was estimated at USD 2.32 billion in 2024 and is expected to grow to USD 3.37 billion in 2029, at a CAGR of 7.9%. The recurrent pericarditis segment specifically is anticipated to grow at a CAGR of 6.6%.
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KPL-387 (investigational): This is an investigational human immunoglobulin G2 monoclonal antibody in a Phase 2/3 clinical trial for advanced recurrent pericarditis. KPL-387 is intended to further expand the IL-1 inhibition market for recurrent pericarditis.
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Mavrilimumab (previously in pipeline): While mavrilimumab was previously in development for Giant Cell Arteritis (GCA), Kiniksa has discontinued its development for this indication.
- For **Giant Cell Arteritis**, the estimated U.S. prevalence is approximately 75,000 – 150,000 patients.
- The global Giant Cell Arteritis Therapeutics Market was valued at approximately USD 1.14 billion in 2024 and is projected to reach nearly USD 1.82 billion by 2032, with a CAGR of 6% from 2025 to 2032.
- Across the top 7 markets (US, EU4, UK, and Japan), the giant cell arteritis market reached USD 1,180.4 million in 2024 and is expected to reach USD 1,945.5 million by 2035.
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Vixarelimab (licensed out): Kiniksa has entered a global license agreement with Roche and Genentech for the development and commercialization of vixarelimab.
- It was being evaluated for **prurigo nodularis**, a chronic inflammatory skin condition with an estimated U.S. prevalence of approximately 300,000 patients.
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KPL-404 (investigational): In Phase 2 clinical trials for **rheumatoid arthritis**.
- The broader global tumor necrosis factor (TNF) inhibitor drugs market, which includes treatments for rheumatoid arthritis, was valued at USD 41.3 billion in 2023 and is projected to reach USD 51.55 billion by 2034, growing at a CAGR of 1.86% from 2025 to 2034. North America holds the largest share of this market.
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Kiniksa Pharmaceuticals International (KNSA) is anticipated to experience future revenue growth over the next 2-3 years, driven by several key factors:
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Continued Expansion of ARCALYST Market Penetration: The primary driver for Kiniksa's near-term revenue growth is the ongoing expansion of ARCALYST's (rilonacept) market penetration for recurrent pericarditis. The company has consistently raised its 2025 net sales guidance for ARCALYST, projecting it to be between $670 million and $675 million. This growth is fueled by an increasing number of active commercial patients, a growing prescriber base, and a longer average duration of therapy. As of late 2024/mid-2025, only approximately 13-15% of the estimated 14,000 multiple-recurrence patients were on ARCALYST therapy, indicating significant room for further adoption.
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Favorable Evolution of Treatment Guidelines for Recurrent Pericarditis: There is a notable shift in clinical guidelines towards earlier and more frequent use of IL-1 pathway inhibition, which ARCALYST addresses, as a steroid-sparing approach for recurrent pericarditis. This evolving standard of care supports broader and earlier adoption of ARCALYST, contributing to sustained revenue momentum.
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Potential Commercialization of KPL-387 in Recurrent Pericarditis: Kiniksa's pipeline asset, KPL-387, which has received Orphan Drug Designation from the FDA for pericarditis, is expected to be a significant future growth driver. KPL-387 aims to offer an improved dosing regimen with a target profile of monthly subcutaneous injection in a liquid formulation, potentially enhancing patient convenience and further expanding the recurrent pericarditis market. Data from its Phase 2 dose-focusing trial is anticipated in the second half of 2026. Additionally, KPL-387 and KPL-1161 (another next-generation IL-1 monoclonal antibody) are wholly owned by Kiniksa, meaning the company would retain all profits, unlike ARCALYST, which is subject to profit-sharing.
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Advancement of Other Pipeline Assets: Beyond ARCALYST and KPL-387, Kiniksa's broader pipeline, including KPL-1161 for recurrent pericarditis (with a target of quarterly dosing) and Vixarelimab for prurigo nodularis (currently in Phase 2b clinical trials), represents opportunities for revenue diversification. Successful development and potential commercialization of these assets would reduce reliance on a single product and provide additional revenue streams in the mid to long term.
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[2] Share Issuance
- In July 2020, Kiniksa Pharmaceuticals priced a public offering of 5,952,381 Class A common shares at $21.00 per share.
- Concurrently in July 2020, the company conducted a private placement of 1,428,572 Class A1 common shares.
- The gross proceeds from both the public offering and concurrent private placement were approximately $155.0 million.
[4] Outbound Investments
- In February 2025, Kiniksa announced the discontinuation of the development of abiprubart in Sjögren's Disease, signaling a reallocation of capital.
- Also in February 2025, the company terminated its exclusive license agreement for mavrilimumab with MedImmune.
[5] Capital Expenditures
- For the last 12 months as of November 7, 2025, capital expenditures were approximately -$1.13 million.
- Kiniksa expects to remain cash flow positive on an annual basis and continue investing across its business, including commercialization and pipeline advancement.
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