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]

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------------------|------------------------------------|----------------------|-------|--------------------------|-------|----------------------------------------------------------------------------------------------------------|-------|-----------------------|-----------------|--------------|---------------------------------------------| | | 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 ...