Kiniksa(KNSA) - 2024 Q2 - Quarterly Results

Overview and Highlights 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][22][26] - The company expects to maintain annual cash flow positivity[18][22][26] - 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][22] Portfolio Execution Strong ARCALYST commercial performance with increasing patient penetration and therapy duration, alongside active abiprubart Phase 2b trial enrollment ARCALYST (rilonacept) - ARCALYST net product revenue was $103.4 million for the second quarter of 2024[18] - 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][23] - The average total duration of ARCALYST therapy for recurrent pericarditis increased to approximately 26 months, up from ~23 months in Q1 2024[18][23] - Since its launch in April 2021, over 2,300 prescribers have written ARCALYST prescriptions for recurrent pericarditis[18] - 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] 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] Financial Performance 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) 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] - As of June 30, 2024, Kiniksa had $218.8 million in cash, cash equivalents, and short-term investments, with no debt[25][13] Financial Guidance (Full Year 2024) 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][9] Financial Statements 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 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 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 Kiniksa is a commercial-stage biopharmaceutical company with immune-modulating assets, including ARCALYST and investigational abiprubart About Kiniksa - Kiniksa is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for debilitating diseases with significant unmet medical need[29] - The company's key immune-modulating assets include ARCALYST, abiprubart, and mavrilimumab, which target a range of cardiovascular and autoimmune conditions[29] About ARCALYST - ARCALYST is a weekly, subcutaneously injected recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling[19] - It is FDA-approved for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), and deficiency of IL-1 receptor antagonist (DIRA)[19] About 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] - This mechanism is considered an attractive approach for addressing multiple autoimmune disease pathologies[15] Important Safety Information and Forward-Looking Statements The company provides important safety warnings for ARCALYST and includes forward-looking statements subject to significant risks Important Safety Information about ARCALYST - ARCALYST can lower the immune system's ability to fight infections, and serious, life-threatening infections have occurred[20] - Treatment should be stopped if a serious infection develops[20] - Concomitant use with other IL-1 blockers or TNF blockers is not recommended as it may increase the risk of serious infection[20] - Other risks include potential for cancer, allergic reactions, and changes in blood cholesterol and triglycerides[28] - Common side effects include injection-site reactions and upper respiratory tract infections[28] Forward-Looking Statements - The press release contains forward-looking statements concerning ARCALYST revenue guidance, funding for abiprubart development, and expectations of being cash flow positive[9] - 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] - 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]