Invivyd (IVVD 0.79%), a biotech firm focused on antibodies for infectious diseases, reported earnings for Q2 2025 on August 14, 2025. The company reported a sharp increase in GAAP revenue year over year, with net product revenue of $11.8 million compared to $2.3 million in Q2 2024, mainly from its COVID-19 monoclonal antibody PEMGARDA. However, GAAP revenue of $11.8 million undershot analyst expectations of $23.16 million by nearly half. The reported net loss per share was $(0.12) (GAAP). Despite substantial drops in research and development (R&D) and selling, general and administrative (SG&A) costs (GAAP), continued net losses and a shrinking cash position reflect the firm remains in investment mode. The quarter marked significant pipeline and regulatory advances.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.12) | $(0.02) | $(0.40) | 70.0 % |
| Revenue (GAAP) | $11.8 million | $23.16 million | $2.3 million | 413.0 % |
| R&D Expenses | $9.6 million | $30.3 million | (68.3%) | |
| SG&A Expenses | $16.6 million | $21.1 million | -21.3 % | |
| Cash and Cash Equivalents (end of period) | $34.9 million | N/A |
Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.
About Invivyd and Its Business Model
Invivyd develops monoclonal antibody (mAb) medicines to prevent and treat infectious diseases, with a primary focus on COVID-19 and related viral threats. Its lead product, PEMGARDA, is an antibody authorized as a preventive therapy for COVID-19 in immunocompromised individuals under the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) pathway. This population includes those who do not mount a strong response to vaccination, representing millions of at-risk patients in the U.S.
The firm’s main priorities include gaining full regulatory approvals, expanding its product pipeline to other viruses like respiratory syncytial virus (RSV) and measles, and improving market traction among target healthcare providers. Success rests on effective commercialization of its lead product and maintaining regulatory alignment for evolving COVID-19 strains.
Quarter in Review: Financials, Commercial Progress, and Pipeline Updates
Net product revenue soared 413% year-over-year, reflecting a ramp-up in sales of PEMGARDA, its COVID-19 mAb. However, the GAAP revenue figure was nearly 49.0% below analyst estimates. Management noted particularly modest demand growth, despite the medication now being added to leading oncology guidelines for B-cell lymphomas. The company’s in-house sales force, reorganized during the previous quarter, began to make headway late in the period, but the disruption from shifting away from a contracted model likely impacted momentum.
R&D expenditures (GAAP) plunged 68.4% compared to Q2 2024, mainly due to reduced manufacturing and lower spending on late-stage clinical trials. Total net loss (GAAP) improved significantly, narrowing from $47.2 million in Q2 2024 to $14.7 million. Still, the company missed its prior goal of reaching profitability by the first half of 2025. Management cited slower commercial traction and expense reduction as temporary levers while still chasing top-line growth.
Pipeline progress was a highlight of the quarter. VYD2311, a next-generation mAb for COVID-19, advanced toward a pivotal clinical trial. Invivyd announced “alignment with the U.S. FDA on a rapid pathway to full approval” for VYD2311, pursuing broad indications that include adults and adolescents. Trial data showed an extended half-life of up to 76.0 days by intramuscular injection for VYD2311, based on Phase 1/2 results announced in June 2025, reinforcing the candidate’s potential as a long-acting preventive option. The company also initiated new discovery programs for RSV and measles mAbs, with data updates for these research efforts scheduled for later in 2025.
On the regulatory side, PEMGARDA remains available on an emergency basis only. The product is not yet fully approved and is reserved for people with moderate-to-severe immune compromise. In February 2025, the FDA declined Invivyd’s request to expand PEMGARDA’s use into treatment (not just prevention), but did provide scientific feedback that may benefit newer mAb candidates. Inventory levels remained steady at $25.4 million (GAAP). Additionally, Invivyd secured a $30 million term loan facility to boost its balance sheet.
Product Portfolio and Notable Developments
PEMGARDA, Invivyd’s only product generating meaningful revenue, is a monoclonal antibody given to patients who are at high risk of severe COVID-19 due to weakened immune systems. Most sales growth came from increased outreach to specialists and expanded availability at healthcare sites. Professional society recognition, including inclusion in the National Comprehensive Cancer Network (NCCN) clinical guidelines, supports longer-term adoption efforts. However, commercial execution remains challenged by slow market education and provider hesitancy.
VYD2311, which is still in early clinical stages, is a next-generation monoclonal antibody engineered to have higher potency and a longer half-life compared to PEMGARDA. Recent data showed no severe adverse events and promise for convenient intramuscular administration. The U.S. FDA has agreed to a rapid licensing path, which could hasten commercial launch if further trials succeed. If approved, VYD2311 is expected to broaden Invivyd’s reach beyond the immunocompromised population, potentially including the wider adult and adolescent communities.
Beyond COVID-19, Invivyd is now investing in exploratory mAb programs for respiratory syncytial virus and measles. These efforts are at the preclinical or discovery stage, but updates on their progress are expected during the second half of 2025. Additionally, the company formed a study group to investigate mAb therapy for long COVID and COVID-19 post-vaccination syndromes, aiming to capture emerging demand outside current standard-of-care treatments.
The company’s regulatory positioning, particularly the continued dependence on EUA status for PEMGARDA, implies a degree of business risk. Any regulatory changes or the rise of new COVID-19 strains less sensitive to current therapies could sharply affect revenue, even as cost cuts have bought additional time for future milestones.
Outlook and What to Watch
Management did not provide precise financial guidance for the third quarter or full fiscal 2025. Leadership reiterated its ambition for near-term profitability as respiratory virus season approaches, but described this as aspirational and dependent on stronger sales performance. Recent financing through a term loan facility offers some balance sheet support, though continued losses may require further capital or improved pipeline delivery.
Investors should monitor several key areas in upcoming quarters: the pace of PEMGARDA adoption as respiratory virus activity picks up; and updates on RSV and measles antibody programs.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
