The Company evenly splits profits on sales of ARCALYST with Regeneron, where profits are determined after deducting from net sales of ARCALYST certain costs related to the manufacturing and commercialization of ARCALYST. Such costs include but are not limited to (i) the Company's cost of goods sold for product used, sold or otherwise distributed for patient use by the Company; (ii) customary commercialization expenses, including the cost of the Company's field force, and (iii) the Company's cost to market, ...

Company Performance - Kiniksa Pharmaceuticals reported a quarterly loss of $0.06 per share, better than the Zacks Consensus Estimate of a loss of $0.09, compared to a loss of $0.02 per share a year ago [1] - The company posted revenues of $108.63 million for the quarter, surpassing the Zacks Consensus Estimate by 23.68%, and compared to year-ago revenues of $71.47 million [11] - Over the last four quarters, Kiniksa has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2][11] Market Comparison - Kiniksa Pharmaceuticals shares have increased by approximately 22% since the beginning of the year, outperforming the S&P 500's gain of 16.7% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $99.65 million, and -$0.10 on revenues of $380.84 million for the current fiscal year [5] - The company is expected to post a quarterly loss of $0.42 per share in its upcoming report, reflecting a year-over-year change of -16.7% [6] Estimate Revisions - The estimate revisions trend for Kiniksa Pharmaceuticals is mixed, leading to a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [9] Industry Context - Kiniksa Pharmaceuticals operates within the Zacks Medical - Biomedical and Genetics industry, which is currently in the top 33% of over 250 Zacks industries [14]

2023 | --- | --- | --- | --- | |-------|-------|----------------------------|-------| | | | | | | | | Second Quarter 2024 | | | | | Financial Results and | | | | | Recent Portfolio Execution | | JULY 23, 2024 | --- | --- | --- | --- | |-------|-------|----------------------------|-------| | | | | | | | | Second Quarter 2024 | | | | | Financial Results and | | | | | Recent Portfolio Execution | | Agenda | --- | --- | |---------------------------------------------------------------------------------|-------| ...

[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]