Adagio(IVVD) - 2025 Q2 - Quarterly Results

Management Commentary Management expressed optimism for VYD2311 as a COVID-19 alternative, focused on PEMGARDA® growth, and pipeline expansion into RSV and measles - The company is actively designing the clinical and go-to-market strategy for VYD2311, which it views as a potential alternative to COVID-19 vaccination[2] - While PEMGARDA's Q2 growth was modest, the company is focused on solidifying its market position as a leading provider of monoclonal antibody technology for COVID-19 protection[2] - Pipeline expansion is a key focus, with plans to identify a best-in-class RSV candidate in Q3 2025 and a preclinical measles candidate by the end of 2025[2] Recent Business Highlights Invivyd achieved significant PEMGARDA® revenue growth, advanced VYD2311 with FDA alignment, expanded its pipeline, and secured additional financing Commercial Execution PEMGARDA® uptake is growing among immunocompromised patients, supported by an expanded sales force and NCCN® guideline inclusion - Uptake of PEMGARDA® is growing among providers for immunocompromised patients, supported by an expanded internal sales force[5] - Pemivibart has been added to the NCCN® Clinical Practice Guidelines in Oncology for B-Cell Lymphomas, a key endorsement[5] Clinical & Regulatory Developments Invivyd reported positive VYD2311 Phase 1/2 data, demonstrating a long half-life and aligning with the FDA on a rapid BLA pathway via a single Phase 2/3 trial - VYD2311 demonstrated a favorable safety profile in its Phase 1/2 trial, with an observed half-life of 76 days for the intramuscular (IM) route, suggesting potential for long-term protection[4][8] - The company has aligned with the U.S. FDA on a rapid pathway to full approval (BLA) for VYD2311, intended to protect adults and adolescents from COVID-19[4][8] - The BLA pathway will be supported by a single Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of reduction in symptomatic COVID-19[8] Pipeline Expansion The company is actively expanding its pipeline beyond SARS-CoV-2, targeting RSV and measles candidates for identification by Q4 2025 - Invivyd has initiated discovery efforts to expand its pipeline to include potential targets like respiratory syncytial virus (RSV) and measles[8] - The company expects to provide an update on the identification of an RSV candidate in Q3 2025 and a preclinical measles candidate in Q4 2025[8] Corporate and Financial Updates Invivyd formed the SPEAR Study Group for Long COVID research and secured a $30 million non-dilutive term loan facility to strengthen its financial position - In July 2025, the SPEAR (Spike Protein Elimination and Recovery) Study Group was formed to assess mAb therapy for Long COVID[13] - In April 2025, the company entered into a $30 million non-dilutive term loan facility with Silicon Valley Bank to support balance sheet optionality[13] Second Quarter 2025 Financial Results Invivyd reported $11.8 million net product revenue for Q2 2025, a 413% increase, significantly reducing its net loss to $14.7 million due to higher revenue and lower R&D expenses Statement of Operations Q2 2025 saw total revenue reach $11.8 million, a substantial increase from the prior year, with reduced operating expenses leading to a narrowed net loss of $14.7 million Q2 2025 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Product Revenue, Net | $11,786 | $2,264 | +413% | | R&D Expenses | $9,573 | $30,334 | -68.4% | | SG&A Expenses | $16,588 | $21,089 | -21.3% | | Loss from Operations | ($15,060) | ($49,247) | +69.4% | | Net Loss | ($14,660) | ($47,247) | +68.9% | | Net Loss Per Share | ($0.12) | ($0.40) | +70.0% | Balance Sheet As of June 30, 2025, Invivyd reported total assets of $89.1 million, total liabilities of $46.3 million, and cash and cash equivalents of $34.9 million Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $34,905 | $69,349 | | Total current assets | $59,281 | $100,681 | | Total assets | $89,138 | $129,515 | | Total current liabilities | $44,451 | $61,976 | | Total liabilities | $46,349 | $61,976 | | Total stockholders' equity | $42,789 | $67,539 | Product and Pipeline Overview This section details PEMGARDA®, an authorized COVID-19 prevention antibody, VYD2311, a next-generation candidate, and the foundational CANOPY clinical trial data PEMGARDA® (pemivibart) PEMGARDA® is an FDA-authorized monoclonal antibody for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals, with a boxed warning for anaphylaxis - PEMGARDA is authorized under an EUA for pre-exposure prophylaxis of COVID-19 in adults and adolescents (≥12 years, ≥40 kg) with moderate-to-severe immune compromise[11] - It is not authorized for treatment of COVID-19 or post-exposure prophylaxis and is not a substitute for recommended COVID-19 vaccination[12] - The product has a boxed warning for anaphylaxis, which has been observed in patients[14] VYD2311 VYD2311 is a novel, next-generation monoclonal antibody for COVID-19 prevention and treatment, engineered for broad neutralization and patient-friendly intramuscular administration - VYD2311 is a novel mAb candidate being developed for both COVID-19 prevention and treatment[18] - Its pharmacokinetic profile may enable more patient-friendly delivery, such as an intramuscular (IM) route of administration[18] - The antibody was engineered using Invivyd's proprietary platform to optimize neutralization of contemporary virus lineages[19] CANOPY Clinical Trial The CANOPY Phase 3 trial evaluated pemivibart's safety and immunobridging, enrolling immunocompromised and at-risk adults - The CANOPY Phase 3 trial was designed to assess the safety of pemivibart and to use an immunobridging approach to historical data for the prevention of symptomatic COVID-19[17] - The trial enrolled two groups: Cohort A (moderate-to-severe immune compromise) and Cohort B (adults without immune compromise but at risk of infection)[17] Cautionary Note Regarding Forward-Looking Statements This section warns investors that forward-looking statements are subject to significant risks, including market acceptance, regulatory outcomes, and clinical trial success, which could cause actual results to differ - The report includes forward-looking statements concerning profitability targets, market position, R&D plans for VYD2311, and pipeline expansion into RSV and measles[22] - Numerous risks could cause actual results to differ, including market acceptance and reimbursement for PEMGARDA, regulatory approval processes, clinical trial enrollment and outcomes, competition, and manufacturing challenges[22]