– American Heart Association to work with champions at 15 healthcare sites to implement initiative activities and improve care quality – "We are proud to sponsor the American Heart Association's Addressing Recurrent Pericarditis initiative. Recurrent pericarditis is a rare, chronic, flaring disease, in which patients are frequently misdiagnosed or undertreated due to a lack of access to expert care. In addition to elevating awareness and knowledge around recurrent pericarditis, this initiative will also hel ...

Financial Performance - Total revenue for Q1 2024 was $79.858 million, a 65% increase from $48.345 million in Q1 2023[24] - Product revenue, net, reached $78.885 million, up from $42.659 million year-over-year, reflecting a significant growth in sales[24] - Net loss for Q1 2024 was $17.704 million, compared to a net loss of $12.270 million in Q1 2023, indicating increased operational costs[24] - Total operating expenses increased to $96.400 million in Q1 2024, up from $59.541 million in Q1 2023, driven by higher research and development and selling expenses[24] - For the three months ended March 31, 2024, the net loss attributable to common shareholders was $17,704, compared to a net loss of $12,270 for the same period in 2023, resulting in a basic and diluted net loss per share of $(0.25) compared to $(0.18) in 2023[114] Cash and Liquidity - Cash and cash equivalents at the end of Q1 2024 were $141.078 million, an increase from $107.954 million at the end of Q4 2023[28] - Cash flows from operating activities provided $3.987 million in Q1 2024, contrasting with a cash outflow of $4.267 million in Q1 2023[28] - The company had cash, cash equivalents, and short-term investments totaling $213,552 as of March 31, 2024, which is expected to be sufficient to fund operations for at least twelve months[37] - The company expects that its cash and investments will be sufficient to meet its operational and capital expenditure requirements for the next twelve months[37] - Cash equivalents in money market funds were valued at $114,419 as of March 31, 2024, compared to $43,554 as of December 31, 2023[44] Research and Development - Research and development expenses rose to $26.334 million in Q1 2024, up from $15.172 million in Q1 2023, reflecting ongoing investment in product development[24] - The company expects substantial research and development expenses over the next several years as it conducts ongoing and planned clinical trials for its product candidates[162] - The company plans to initiate a Phase 2b clinical trial of abiprubart in Sjögren's Disease in the second half of 2024, following positive topline data from the rheumatoid arthritis trial[1] - The company is evaluating potential partnership opportunities to advance the development of mavrilimumab, which targets GM-CSFRα[140] Collaboration and Revenue Agreements - The Company recognized $105 million of collaboration revenue under the Genentech License Agreement during the three months ended March 31, 2024[76] - The Company is eligible to receive approximately $600 million in contingent payments under the Genentech License Agreement, with approximately $575 million remaining as of March 31, 2024[69] - The Company received an upfront payment of $80 million under the Genentech License Agreement, with additional payments totaling $25 million recognized in 2023[69] - The Company received a total upfront cash payment of $22,000, including $12,000 for the rilonacept license and $10,000 for the mavrilimumab license under the Huadong Collaboration Agreements[78] Inventory and Assets - Total inventory as of March 31, 2024, was $28,304, a decrease from $31,122 as of December 31, 2023[51] - The company’s total assets decreased slightly to $519.673 million as of March 31, 2024, down from $526.322 million at the end of 2023[22] - The company classified inventory as $27,278 in current assets and $1,026 in other long-term assets as of March 31, 2024[51] Expenses and Obligations - Accrued research and development expenses increased to $11,028 million as of March 31, 2024, compared to $7,895 million as of December 31, 2023[57] - The Company recorded research and development expense of $61 related to the Biogen Agreement during the three months ended March 31, 2024[97] - The Company has committed to minimum payments under various agreements totaling $148,039, with $56,140 due within one year as of March 31, 2024[132] Tax and Regulatory Matters - The income tax provision for the three months ended March 31, 2024, was $3,428, primarily driven by income earned in the UK, Switzerland, and the U.S.[118] - The Company is subject to zero percent corporate income tax in Bermuda, but future legislation could impose taxes starting in 2025[167] Corporate Developments - The company announced plans to redomicile from Bermuda to the United Kingdom, with a shareholder meeting scheduled for June 5, 2024, to approve the move[210] - The redomiciliation is expected to improve the company's position regarding OECD tax proposals and provide continuity of legal rights for shareholders[213] - The company anticipates incurring additional costs related to the redomiciliation, including legal and compliance expenses[217] Market and Shareholder Considerations - The market for the newly issued Class A ordinary shares may differ from the current Class A common shares, affecting price and trading volume[216] - The company may abandon or delay the redomiciliation if costs increase or if it is deemed not in the best interests of shareholders[219] Internal Controls and Risk Management - There were no material changes to the company's internal control over financial reporting during the three months ended March 31, 2024[206] - The company is exposed to interest rate risks related to short-term investments, with no material changes reported in market risk disclosures[203]

Financial Data and Key Metrics - Q1 2024 net revenue for ARCALYST was $78.9 million, representing 85% YoY growth [20] - Total revenue for Q1 2024 was $79.9 million, driven by ARCALYST net product revenue [38] - ARCALYST collaboration operating profit grew 142% YoY to $40.2 million in Q1 2024 [39] - Net loss in Q1 2024 was $17.7 million, compared to $12.3 million in Q1 2023 [28] - Cash balance at the end of Q1 2024 was $213.6 million, reflecting net cash flow of $7.2 million [28] Business Line Data and Key Metrics - ARCALYST full-year sales guidance for 2024 increased to $370 million - $390 million, representing 63% YoY growth at the midpoint [5] - Total prescribers of ARCALYST grew to approximately 2,000 at the end of Q1 2024, marking the largest quarter-on-quarter growth since launch [8] - Greater than 90% payer approval rate for completed cases and an average duration of therapy of 23 months for ARCALYST [8] - 40% of new prescriptions in Q1 were written by repeat prescribers [22] Market Data and Key Metrics - Only 9% of the target population for ARCALYST has been addressed as of the end of 2023, indicating significant growth potential [25] - The RESONANCE Registry shows a paradigm shift in recurrent pericarditis management, with 65% of transitions in 2023 made to ARCALYST, a 2:1 preference over corticosteroids [11] Company Strategy and Industry Competition - The company plans to initiate a Phase 2b trial for Abiprubart in Sjögren's Disease in the second half of 2024, targeting a debilitating disease with no FDA-approved therapies [19][27] - ARCALYST is positioned as a steroid-sparing therapy, addressing the root cause of recurrent pericarditis through IL-1 pathway inhibition [33] - The company expects to remain cash flow positive on an annual basis, supported by strong commercial execution and financial discipline [29][31] Management Commentary on Operating Environment and Future Outlook - Management highlighted robust growth in ARCALYST, driven by increasing prescriber adoption and high physician and patient satisfaction [4][17] - The company is optimistic about the future of ARCALYST, with strong underlying business fundamentals and significant market opportunity [25][31] - Management emphasized the importance of the RESONANCE Registry in understanding disease management and driving evidence-based adoption of ARCALYST [71][92] Other Important Information - The company received a $10 million development milestone from Genentech in Q1 2024, previously recognized as revenue in Q4 2023 [28] - The Phase 2b trial for Abiprubart will evaluate subcutaneous administration with biweekly and monthly dosing regimens, aiming for differentiation in the Sjögren's Disease market [27][66] Q&A Session Summary Question: Growth in ARCALYST prescribers and sales force impact [46] - The growth in prescribers is attributed to both the expanded sales force, which now covers 11,000 physicians, and deeper penetration into top-tier academic centers [57][59] Question: Patient behavior trends and therapy restart rates [80] - Restart rates for ARCALYST therapy remain consistent at 45%, with no significant changes in patient behavior observed [80][81] Question: Competitive landscape for Abiprubart in Sjögren's Disease [53] - Abiprubart's differentiation lies in its subcutaneous dosing and strong biological activity, with a 40% reduction in rheumatoid factor across all dosing regimens [65][66] Question: ARCALYST market shift and physician paradigm [85] - The market is shifting towards using ARCALYST after initial treatments like Aspirin and Colchicine fail, particularly for patients with multiple recurrences [85][86] Question: Strategic importance of profitability vs pipeline expansion [70] - The company remains committed to both profitability and pipeline expansion, with a focus on creating value while maintaining cash flow positivity [74][75] Question: Plans for publishing RESONANCE Registry data [90] - The RESONANCE Registry is a key tool for understanding disease management, and the company plans to continue sharing insights from the registry [71][92]

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------------------|------------------------------------|----------------------|-------|--------------------------|-------|----------------------------------------------------------------------------------------------------------|-------|-----------------------|-----------------|--------------|---------------------------------------------| | | 15% | 12% 00/ | 2% \n740 | | 4% \n29/0 | | | 100% | Rilonacept in RP \ ...

Kiniksa Pharmaceuticals, Ltd. (KNSA) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.18 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -78.57%. A quarter ago, it was expected that this company would post a loss of $0.11 per share when it actually produced earnings of $0.04, delivering a surprise of 136.36%.Over the last four quarters, the co ...

[Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) Kiniksa reported strong Q1 2024 results with significant ARCALYST revenue growth and raised full-year guidance, while advancing pipeline and maintaining positive cash flow expectations ARCALYST Net Product Revenue | Metric | Q1 2024 | YoY Growth | | :--- | :--- | :--- | | ARCALYST Net Product Revenue | $78.9 million | 85% | ARCALYST 2024 Net Product Revenue Guidance | Guidance | Previous Range | Updated Range | | :--- | :--- | :--- | | ARCALYST 2024 Net Product Revenue | $360 - $380 million | $370 - $390 million | - A **Phase 2b trial** for **Abiprubart** in **Sjögren's Disease** is planned to start in the second half of 2024[1](index=1&type=chunk)[7](index=7&type=chunk) - The company expects its current operating plan to maintain a **positive cash flow** on an annual basis[1](index=1&type=chunk)[3](index=3&type=chunk)[11](index=11&type=chunk) [Portfolio Execution](index=1&type=section&id=Portfolio%20Execution) Portfolio execution is driven by strong ARCALYST commercial performance and pipeline advancements for Abiprubart and Mavrilimumab [ARCALYST (rilonacept)](index=1&type=section&id=ARCALYST%20(rilonacept)) ARCALYST generated **$78.9 million** in Q1 2024 revenue, with expanding prescriber base and increasing use in recurrent pericarditis - ARCALYST net product revenue was **$78.9 million** for the first quarter of 2024[5](index=5&type=chunk) - Since its launch in April 2021, approximately **2,000 prescribers** have written ARCALYST prescriptions for recurrent pericarditis[5](index=5&type=chunk) - The average total duration of ARCALYST therapy in recurrent pericarditis was approximately **23 months** as of the end of Q1 2024[5](index=5&type=chunk) - Data from the RESONANCE patient registry presented at ACC.24 shows an increasing proportional use of ARCALYST compared to and in advance of corticosteroids since its commercial availability in 2021[6](index=6&type=chunk) [Abiprubart](index=2&type=section&id=Abiprubart) A Phase 2b trial for Abiprubart in Sjögren's Disease is scheduled to commence in the second half of 2024 - The company expects to initiate a **Phase 2b trial** for **Abiprubart** in patients with **Sjögren's Disease** in **2H 2024**, evaluating biweekly and monthly subcutaneous administration[7](index=7&type=chunk) [Mavrilimumab](index=2&type=section&id=Mavrilimumab) Kiniksa is actively exploring partnership opportunities to advance the development of Mavrilimumab - Kiniksa is evaluating potential partnership opportunities to advance the development of mavrilimumab[8](index=8&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Q1 2024 saw total revenue increase to **$79.9 million**, but higher operating expenses led to a **$17.7 million** net loss, while the balance sheet remains strong [Financial Results (Q1 2024)](index=2&type=section&id=Financial%20Results%20(Q1%202024)) Q1 2024 total revenues reached **$79.9 million**, with a net loss of **$17.7 million** and **$213.6 million** in cash and equivalents Statement of Operations (in thousands) | Statement of Operations (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **Total Revenue** | **$79,858** | **$48,345** | | Product revenue, net | $78,885 | $42,659 | | **Total Operating Expenses** | **$96,400** | **$59,541** | | Research and development | $26,334 | $15,172 | | Selling, general and administrative | $38,682 | $29,045 | | **Net Loss** | **$(17,704)** | **$(12,270)** | | Net Loss Per Share | $(0.25) | $(0.18) | Balance Sheet Data (in thousands) | Balance Sheet Data (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $213,552 | $206,371 | | Total assets | $519,673 | $526,322 | | Total shareholders' equity | $431,895 | $438,839 | [Financial Guidance (FY 2024)](index=2&type=section&id=Financial%20Guidance%20(FY%202024)) Kiniksa raised its FY 2024 ARCALYST net product revenue guidance to **$370-$390 million** and expects annual cash flow positivity ARCALYST 2024 Net Product Revenue Guidance | Guidance | Previous Range | Updated Range | | :--- | :--- | :--- | | ARCALYST 2024 Net Product Revenue | $360 - $380 million | $370 - $390 million | - Kiniksa expects its current operating plan to remain **cash flow positive** on an annual basis[3](index=3&type=chunk)[11](index=11&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) This section outlines Kiniksa's business, product portfolio including ARCALYST, Abiprubart, and Mavrilimumab, and forward-looking statement disclaimers [About Kiniksa and its Products](index=3&type=section&id=About%20Kiniksa%20and%20its%20Products) Kiniksa is a commercial-stage biopharmaceutical company developing immune-modulating therapies like ARCALYST, Abiprubart, and Mavrilimumab - Kiniksa is a **commercial-stage biopharmaceutical company** focused on discovering, acquiring, developing, and commercializing therapeutic medicines for debilitating diseases with significant unmet medical need[13](index=13&type=chunk) - **ARCALYST** is a weekly, subcutaneously injected protein that blocks **IL-1α and IL-1β signaling**, approved by the FDA for **recurrent pericarditis, CAPS, and DIRA**[14](index=14&type=chunk) - **Abiprubart** is an investigational monoclonal antibody designed to inhibit the **CD40-CD154 interaction**, a key T-cell co-stimulatory signal critical for B-cell maturation[17](index=17&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section includes a disclaimer regarding forward-looking statements, highlighting inherent risks and uncertainties that may affect actual results - The press release contains **forward-looking statements**, including **revenue guidance for ARCALYST**, **clinical trial plans for abiprubart**, and expectations of being **cash flow positive**[19](index=19&type=chunk) - These statements involve **known and unknown risks and uncertainties**, and **actual results may differ materially** The company disclaims any obligation to update these statements[21](index=21&type=chunk)[22](index=22&type=chunk)

– ARCALYST® (rilonacept) Q1 2024 net product revenue of $78.9 million, representing 85% year-over-year growth –– ARCALYST 2024 expected net product revenue increased to $370 - $390 million –– Abiprubart Phase 2b trial in Sjögren's Disease planned to initiate in 2H 2024 –– Current operating plan expected to remain cash flow positive on an annual basis – – Conference call and webcast scheduled for 8:30 am ET today – HAMILTON, Bermuda, April 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KN ...

HAMILTON, Bermuda, April 16, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, April 23, 2024 at 8:30 a.m. Eastern Time to report its first quarter 2024 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon r ...

HAMILTON, Bermuda, April 16, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) announced today that it will host a conference call and live webcast on Tuesday, April 23, 2024 at 8:30 a.m. Eastern Time to report its first quarter 2024 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company's website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon re ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Table of Contents OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38492 Kiniksa Pharmaceuticals, Ltd. (Exact name of registrant as specified in its charter) Bermuda 98-1327726 (I.R ...