Vaxcyte(PCVX) - 2024 Q2 - Quarterly Results

Vaxcyte Second Quarter 2024 Business Update and Financial Results Vaxcyte reported Q2 2024 financial results and business updates, highlighting progress in its vaccine pipeline and financial position Business and Operational Highlights Vaxcyte advanced its PCV programs, published VAX-24 Phase 2 data, secured a NIAID grant, and appointed a new Board member - VAX-24 Phase 2 study results in adults aged 65 and older were published in the journal Vaccine, demonstrating a safety and tolerability profile comparable to Prevnar 20® (PCV20) and an overall improvement in immune responses for the 2.2mcg dose[3] - The National Institute of Allergy and Infectious Diseases (NIAID) awarded a five-year, $9.5 million grant to a consortium including Vaxcyte to develop a preclinical vaccine candidate for Chlamydia[4] - In July 2024, Vaxcyte appointed John Furey, a seasoned biopharmaceutical executive with extensive vaccine experience from Pfizer and Wyeth, to its Board of Directors[4] Anticipated Key Milestones Vaxcyte detailed upcoming clinical milestones for its PCV franchise, including VAX-31 adult Phase 1/2 data and VAX-24 infant Phase 2 study timelines - PCV Franchise - Adult Indication: Announce topline safety, tolerability, and immunogenicity data from the VAX-31 adult Phase 1/2 study in September 2024; advance either VAX-24 or VAX-31 to a Phase 3 program, with VAX-24 Phase 3 data expected in H2 2025 or VAX-31 Phase 3 studies initiating in 2025 and 2026[5] - PCV Franchise - Infant Indication (VAX-24): Announce topline data from the primary three-dose immunization series by end of Q1 2025 and from the booster dose by end of 2025[6] Second Quarter 2024 Financial Results Vaxcyte maintained a strong cash position while reporting increased operating expenses and a higher net loss due to R&D investments in its PCV programs Key Financial Metrics | Financial Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Cash, Cash Equivalents & Investments | $1,851.9 million | N/A (vs. $1,242.9M at Dec 31, 2023) | | R&D Expenses | $131.5 million | $72.7 million | | G&A Expenses | $21.5 million | $14.5 million | | Net Loss | $128.7 million | $68.3 million | - The increase in R&D expenses was primarily due to higher manufacturing costs for PCV programs, expenses for VAX-31 adult and VAX-24 infant clinical studies, and growth in R&D personnel[7] - The company incurred an additional $38.2 million in capital expenditures for its dedicated manufacturing suite at Lonza, bringing the total incurred to $140.0 million as of June 30, 2024[8] Financial Statements This section presents the unaudited condensed consolidated statements of operations and summary balance sheet data for the second quarter of 2024 Condensed Consolidated Statements of Operations The company reported a net loss of $128.7 million, or $1.10 per share, for the three months ended June 30, 2024 Unaudited Condensed Consolidated Statements of Operations | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | | Research and development | $131,507 | $72,691 | | General and administrative | $21,474 | $14,456 | | Total operating expenses | $152,981 | $87,147 | | Loss from operations | $(152,981) | $(87,147) | | Interest income | $23,813 | $16,451 | | Net loss | $(128,703) | $(68,339) | | Net loss per share | $(1.10) | $(0.70) | Summary Consolidated Balance Sheet Data The balance sheet highlights $2.09 billion in total assets and $1.99 billion in total stockholders' equity as of June 30, 2024 Unaudited Summary Consolidated Balance Sheet Data | Metric (in thousands) | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $1,851,940 | $1,242,902 | | Total assets | $2,087,267 | $1,407,917 | | Total stockholders' equity | $1,986,132 | $1,240,468 |