Vaxcyte(PCVX) - 2025 Q1 - Quarterly Results

Management Summary and Outlook Management highlighted significant progress in their pneumococcal conjugate vaccine (PCV) pipeline, including VAX-24 and VAX-31, aiming to redefine the standard of care, while confirming a strong financial position with approximately $3.0 billion in cash - CEO Grant Pickering emphasized progress towards delivering broader-spectrum PCVs for both adults and infants, with key data readouts and study initiations planned for 2025 and 2026[3] - CFO Andrew Guggenhime confirmed a strong balance sheet with approximately $3.0 billion in cash, cash equivalents, and investments, enabling the company to advance its PCV pipeline[2][3] Key First Quarter Highlights During the first quarter, Vaxcyte reported positive topline results from the VAX-24 infant Phase 2 study, advanced the VAX-31 infant Phase 2 study to its second stage, and announced its next-generation VAX-XL candidate, additionally strengthening its Board of Directors with a key appointment PCV Franchise Developments The company made significant strides in its PCV franchise, with VAX-24 showing positive safety and immunogenicity in its infant Phase 2 study, VAX-31 progressing to its final stage, and the unveiling of VAX-XL for broader coverage - In March 2025, Vaxcyte announced positive topline results for the VAX-24 infant Phase 2 study, showing it was well-tolerated with a safety profile similar to Prevnar 20®[4] - The VAX-24 Mid dose met target non-inferiority criteria for 20 of 24 serotypes and generated robust OPA responses, with full booster data expected by the end of 2025[5] - The VAX-31 infant Phase 2 dose-finding study advanced to its second and final stage in February 2025, following a positive safety assessment[5] - Vaxcyte announced VAX-XL in March 2025, its third-generation PCV candidate designed to offer the broadest coverage for infants and adults[5] Board of Directors Appointment In May 2025, Vaxcyte appointed Dr. Olivier Brandicourt, former CEO of Sanofi S.A. and Bayer HealthCare AG, to its Board of Directors, bringing extensive experience in commercial strategy and the global vaccine market - Dr. Olivier Brandicourt was appointed to the Board of Directors, bringing significant biopharmaceutical and global vaccine market expertise[6] Anticipated Key Milestones Vaxcyte outlined several key upcoming milestones for its PCV programs, including the VAX-31 Phase 3 study for adults by mid-2025, and further data from the VAX-24 and VAX-31 infant studies by the end of 2025 and mid-2026, respectively VAX-31 (Adult Indication) The company plans to initiate a pivotal Phase 3 non-inferiority study for VAX-31 in adults by mid-2025, with topline data expected in 2026, and subsequent Phase 3 studies planned for 2025 and 2026 - A Phase 3 pivotal, non-inferiority study for VAX-31 in adults is expected to start by mid-2025[11] - Topline safety, tolerability, and immunogenicity data from this study are anticipated in 2026[11] VAX-24 & VAX-31 (Infant Indication) Key data for the infant PCV programs are expected soon, with the balance of the VAX-24 Phase 2 data due by the end of 2025, and initial data from the VAX-31 Phase 2 primary immunization series anticipated in mid-2026 - The balance of the VAX-24 Phase 2 dose-finding study data, including full post-dose 3 and post-dose 4 results, is expected by the end of 2025[8] - Topline data for the VAX-31 Phase 2 study's primary three-dose series is expected in mid-2026, with complete booster data up to nine months later[9] Upcoming Investor Conferences Vaxcyte management will participate in three investor conferences in May and June 2025: the BofA Securities Health Care Conference, the Jefferies Global Healthcare Conference, and the Goldman Sachs Global Healthcare Conference - Management will participate in fireside chats and meetings at the BofA Securities, Jefferies, and Goldman Sachs healthcare conferences in May and June 2025[10][12][13] First Quarter 2025 Financial Results For the first quarter of 2025, Vaxcyte reported a net loss of $140.7 million, with cash, cash equivalents, and investments at $2.95 billion as of March 31, 2025, and increased operating expenses driven by higher R&D activities and G&A personnel costs Key Financial Data (Q1 2025 vs Q1 2024) | Financial Metric | Q1 2025 (USD Millions) | Q1 2024 (USD Millions) | Change (%) | | :--- | :--- | :--- | :--- | | R&D Expenses | 148.1 | 94.6 | +56.5 | | G&A Expenses | 32.7 | 19.9 | +64.3 | | Net Loss | (140.7) | (95.0) | +48.1 | Cash Position | Date | Cash, Cash Equivalents and Investments (USD Millions) | | :--- | :--- | | March 31, 2025 | 2,950.8 | | December 31, 2024 | 3,134.7 | - The increase in R&D expenses was primarily due to development and manufacturing activities for the PCV programs and higher personnel costs[16] - The company incurred an additional $31.7 million in capital expenditures for its dedicated manufacturing suite, with total incurred costs reaching $246.0 million as of March 31, 2025[16] Consolidated Financial Statements The consolidated financial statements provide detailed financial data for Vaxcyte, showing a net loss of $140.7 million for the three months ended March 31, 2025, and total assets of $3.38 billion with total stockholders' equity of $3.20 billion as of March 31, 2025 Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Vaxcyte reported total operating expenses of $180.8 million and a net loss of $140.7 million, or $1.04 per share, compared to a net loss of $95.0 million, or $0.85 per share, for the same period in 2024 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, (USD Thousands) | | | :--- | :--- | :--- | | | 2025 | 2024 | | Operating expenses: | | | | Research and development | 148,134 | 94,587 | | General and administrative | 32,659 | 19,885 | | Total operating expenses | 180,793 | 114,472 | | Loss from operations | (180,793) | (114,472) | | Interest income | 32,935 | 21,666 | | Net loss | (140,718) | (95,020) | | Net loss per share, basic and diluted | (1.04) | (0.85) | | Weighted-average shares outstanding | 135,690,949 | 111,690,951 | Summary Consolidated Balance Sheet Data As of March 31, 2025, Vaxcyte's balance sheet showed $2.95 billion in cash, cash equivalents, and investments, total assets of $3.38 billion, and total stockholders' equity of $3.20 billion Summary Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 (USD Thousands) | December 31, 2024 (USD Thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and investments | 2,950,762 | 3,134,718 | | Total assets | 3,378,103 | 3,511,318 | | Total stockholders' equity | 3,200,026 | 3,305,819 |