[Overview and Highlights](index=1&type=section&id=Overview%20and%20Highlights) Kiniksa reported strong Q2 2024 results, raising ARCALYST revenue guidance and advancing abiprubart's Phase 2b trial Q2 2024 Key Highlights | Metric | Q2 2024 Value | Year-over-Year Growth | | :--- | :--- | :--- | | ARCALYST Net Product Revenue | $103.4 million | 90% | - Raised full-year 2024 ARCALYST net product revenue guidance to **$405 - $415 million**, up from the previous range of **$370 - $390 million**[18](index=18&type=chunk)[22](index=22&type=chunk)[26](index=26&type=chunk) - The company expects to maintain annual cash flow positivity[18](index=18&type=chunk)[22](index=22&type=chunk)[26](index=26&type=chunk) - Clinical development for abiprubart in Sjögren's Disease is fully funded within the current operating plan, and the Phase 2b trial is enrolling patients[18](index=18&type=chunk)[22](index=22&type=chunk) [Portfolio Execution](index=1&type=section&id=Portfolio%20Execution) Strong ARCALYST commercial performance with increasing patient penetration and therapy duration, alongside active abiprubart Phase 2b trial enrollment [ARCALYST (rilonacept)](index=1&type=section&id=ARCALYST%20%28rilonacept%29) - ARCALYST net product revenue was **$103.4 million** for the second quarter of 2024[18](index=18&type=chunk) - As of Q2 2024, approximately **11%** of the **14,000** target patients with multiple-recurrence pericarditis were on ARCALYST, up from **~9%** at the end of 2023[18](index=18&type=chunk)[23](index=23&type=chunk) - The average total duration of ARCALYST therapy for recurrent pericarditis increased to approximately **26 months**, up from **~23 months** in Q1 2024[18](index=18&type=chunk)[23](index=23&type=chunk) - Since its launch in April 2021, over **2,300** prescribers have written ARCALYST prescriptions for recurrent pericarditis[18](index=18&type=chunk) - Kiniksa has sponsored the American Heart Association's 'Addressing Recurrent Pericarditis' initiative and partnered with NHL Hall-of-Famer Henrik Lundqvist to raise awareness[23](index=23&type=chunk) [Abiprubart](index=2&type=section&id=Abiprubart) - Kiniksa is currently enrolling patients in a Phase 2b clinical trial to evaluate the efficacy and safety of abiprubart in patients with Sjögren's Disease[24](index=24&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Kiniksa's Q2 2024 revenue grew to $108.6 million, resulting in a net loss due to increased expenses, while maintaining a strong cash position [Financial Results (Q2 2024)](index=2&type=section&id=Financial%20Results%20%28Q2%202024%29) Q2 2024 vs. Q2 2023 Financial Comparison (in millions) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Total Revenue | $108.6 | $71.5 | | Total Operating Expenses | $108.7 | $74.6 | | Net Income (Loss) | $(3.9) | $15.0 | - Collaboration expenses, driven by ARCALYST profitability, increased to **$30.0 million** in Q2 2024 from **$14.0 million** in Q2 2023[25](index=25&type=chunk) - As of June 30, 2024, Kiniksa had **$218.8 million** in cash, cash equivalents, and short-term investments, with no debt[25](index=25&type=chunk)[13](index=13&type=chunk) [Financial Guidance (Full Year 2024)](index=2&type=section&id=Financial%20Guidance%20%28Full%20Year%202024%29) ARCALYST 2024 Net Product Revenue Guidance (in millions) | Guidance | Amount | | :--- | :--- | | Previous Guidance | $370 - $390 | | Updated Guidance | $405 - $415 | - Kiniksa reaffirms its expectation to remain cash flow positive on an annual basis[26](index=26&type=chunk)[9](index=9&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Detailed financial statements show significant year-over-year revenue growth and increased costs, with a healthy cash position and stable shareholders' equity [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Selected Consolidated Statements of Operations (In thousands, Unaudited) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | **Total revenue** | **$108,631** | **$71,473** | **$188,489** | **$119,818** | | Product revenue, net | $103,394 | $54,495 | $182,279 | $97,154 | | **Total operating expenses** | **$108,748** | **$74,627** | **$205,148** | **$134,168** | | Cost of goods sold | $12,322 | $7,699 | $22,905 | $14,735 | | R&D | $24,017 | $23,767 | $50,351 | $38,939 | | SG&A | $42,395 | $29,175 | $81,077 | $58,220 | | **Loss from operations** | **$(117)** | **$(3,154)** | **$(16,659)** | **$(14,350)** | | **Net income (loss)** | **$(3,908)** | **$14,972** | **$(21,612)** | **$2,702** | | **Net income (loss) per share—diluted** | **$(0.06)** | **$0.21** | **$(0.31)** | **$0.04** | [Consolidated Balance Sheet Data](index=6&type=section&id=Consolidated%20Balance%20Sheet%20Data) Selected Consolidated Balance Sheet Data (In thousands, Unaudited) | | As of June 30, 2024 | As of December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $218,758 | $206,371 | | Working capital | $216,730 | $212,631 | | Total assets | $542,428 | $526,322 | | Total shareholders' equity | $435,095 | $438,839 | [Corporate and Product Information](index=3&type=section&id=Corporate%20and%20Product%20Information) Kiniksa is a commercial-stage biopharmaceutical company with immune-modulating assets, including ARCALYST and investigational abiprubart [About Kiniksa](index=3&type=section&id=About%20Kiniksa) - Kiniksa is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for debilitating diseases with significant unmet medical need[29](index=29&type=chunk) - The company's key immune-modulating assets include ARCALYST, abiprubart, and mavrilimumab, which target a range of cardiovascular and autoimmune conditions[29](index=29&type=chunk) [About ARCALYST](index=3&type=section&id=About%20ARCALYST) - ARCALYST is a weekly, subcutaneously injected recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling[19](index=19&type=chunk) - It is FDA-approved for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), and deficiency of IL-1 receptor antagonist (DIRA)[19](index=19&type=chunk) [About Abiprubart](index=4&type=section&id=Abiprubart) - Abiprubart is an investigational humanized monoclonal antibody designed to inhibit the CD40-CD154 interaction, a key co-stimulatory signal in T-cell and B-cell immune responses[15](index=15&type=chunk) - This mechanism is considered an attractive approach for addressing multiple autoimmune disease pathologies[15](index=15&type=chunk) [Important Safety Information and Forward-Looking Statements](index=3&type=section&id=Important%20Safety%20Information%20and%20Forward-Looking%20Statements) The company provides important safety warnings for ARCALYST and includes forward-looking statements subject to significant risks [Important Safety Information about ARCALYST](index=3&type=section&id=Important%20Safety%20Information%20about%20ARCALYST) - ARCALYST can lower the immune system's ability to fight infections, and serious, life-threatening infections have occurred[20](index=20&type=chunk) - Treatment should be stopped if a serious infection develops[20](index=20&type=chunk) - Concomitant use with other IL-1 blockers or TNF blockers is not recommended as it may increase the risk of serious infection[20](index=20&type=chunk) - Other risks include potential for cancer, allergic reactions, and changes in blood cholesterol and triglycerides[28](index=28&type=chunk) - Common side effects include injection-site reactions and upper respiratory tract infections[28](index=28&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) - The press release contains forward-looking statements concerning ARCALYST revenue guidance, funding for abiprubart development, and expectations of being cash flow positive[9](index=9&type=chunk) - These statements are not guarantees and involve known and unknown risks and uncertainties, such as clinical trial delays, inability to replicate results, and reliance on third-party suppliers[11](index=11&type=chunk) - Readers are cautioned not to place undue reliance on these statements and are directed to the company's SEC filings for a full discussion of risks[12](index=12&type=chunk)

Portfolio Execution ARCALYST (IL-1α and IL-1β cytokine trap) LONDON, July 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immunemodulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported second quarter 2024 financial results and recent portfolio execution. ARCALYST net product revenue was $103.4 million for the second quarter of 2024. Since launch in ...

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more informatio ...

LONDON, July 16, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, July 23, 2024 at 8:30 a.m. Eastern Time to report its second 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 ...

Company Overview - Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients with significant unmet medical needs [1] - The company has a pipeline of immune-modulating assets, including ARCALYST®, abiprubart, and mavrilimumab, targeting underserved cardiovascular and autoimmune conditions [1] Abiprubart Development - Abiprubart is an investigational humanized monoclonal antibody designed to inhibit the CD40-CD154 interaction, which is critical for B-cell maturation and immune responses [4] - The Phase 2b clinical trial of abiprubart in Sjögren's Disease has commenced, with enrollment of approximately 201 patients randomized to receive either abiprubart or placebo over 24 weeks [6][8] - The primary endpoint of the trial is the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24 [6] Financial Outlook - Kiniksa expects to remain cash flow positive on an annual basis while fully funding the clinical development of abiprubart in Sjögren's Disease [9]

– Abiprubart Phase 2b clinical trial in Sjögren's Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations – LONDON, July 09, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced that it has commenced enrollment of the Phase 2b clinical trial of abipruba ...

Company Overview - Kiniksa Pharmaceuticals, Ltd. is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients with debilitating diseases and significant unmet medical needs [1][5] - The company has a pipeline of immune-modulating assets, including ARCALYST, abiprubart, and mavrilimumab, targeting underserved cardiovascular and autoimmune conditions [1][5] Initiative Sponsorship - Kiniksa announced its sponsorship of the American Heart Association's Addressing Recurrent Pericarditis initiative, aimed at improving quality of care for recurrent pericarditis patients [5][11] - The initiative will establish a learning collaborative at fifteen healthcare sites to analyze patient identification and referral pathways, with the goal of improving outcomes and quality of life for patients [7][11] Recurrent Pericarditis Insights - Recurrent pericarditis is characterized by inflammation of the pericardium, leading to significant impacts on quality of life, frequent emergency visits, and hospitalizations [8][12] - Approximately 40,000 patients in the U.S. seek treatment for recurrent pericarditis annually, with around 14,000 experiencing two or more recurrences [8][12]

– 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]