Kiniksa(KNSA) - 2024 Q1 - Quarterly Results

Financial & Operational Highlights 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][7] - The company expects its current operating plan to maintain a positive cash flow on an annual basis[1][3][11] Portfolio Execution Portfolio execution is driven by strong ARCALYST commercial performance and pipeline advancements for Abiprubart and Mavrilimumab ARCALYST (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] - Since its launch in April 2021, approximately 2,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis[5] - The average total duration of ARCALYST therapy in recurrent pericarditis was approximately 23 months as of the end of Q1 2024[5] - 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] 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] 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] Financial Performance 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) 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) 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][11] Corporate Information This section outlines Kiniksa's business, product portfolio including ARCALYST, Abiprubart, and Mavrilimumab, and forward-looking statement disclaimers About Kiniksa and its Products 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] - 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] - 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] Forward-Looking Statements 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] - 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][22]