Core Viewpoint - Invivyd positions its monoclonal antibody VYD2311 as a potent alternative to COVID-19 vaccination, emphasizing its potential for "vaccine-free protection" against symptomatic COVID-19 [1] Company Focus and Pipeline - The company is advancing its REVOLUTION clinical program for VYD2311, continuing the commercialization of PEMGARDA, and exploring additional clinical indications, including long COVID and other infectious diseases like RSV and measles [2][13] - Invivyd has completed enrollment in the pivotal DECLARATION trial for VYD2311, with results expected in mid-2026 [6][9] Financial Performance - Invivyd raised over $200 million in the second half of 2025, ending the year with $226.7 million in cash, which supports operations through pivotal data expected in mid-2026 [4][17] - PEMGARDA's net revenues increased by 31% quarter-over-quarter and 25% year-over-year, totaling $53.4 million for the full year 2025, with a reorder rate of 77% among accounts [5][16] Clinical Trials and Safety Monitoring - The DECLARATION trial is a triple-blind randomized clinical trial evaluating VYD2311's safety and efficacy, with a target enrollment of approximately 1,770 subjects [6][7] - The Independent Data Monitoring Committee has reviewed early safety data and made recommendations regarding participant enrollment and monitoring [7][10] Commercial Strategy - Invivyd is seeing increased clinician interest in monoclonal antibodies for high-risk patients, with PEMGARDA included in guidelines from major health organizations [11][12] - The company is expanding its commercial footprint, with over 15,000 contracted GPO sites [5][14] Future Developments - Invivyd is excited to explore antibodies for long COVID and post-vaccination syndrome, with plans for updates on measles in the first half of the year [13][15]

Financial Performance - Invivyd, Inc. reported Q4 2025 revenue of $17.2 million, surpassing estimates of $15.5 million, indicating strong demand for PEMGARDA [2][5] - The revenue of $17.2 million represents a 25% increase year-over-year and a 31% increase quarter-over-quarter [2] - The company reported an earnings per share (EPS) of -$0.064, slightly below the estimated EPS of -$0.06 [1] Cash Position - By the end of 2025, Invivyd had cash and cash equivalents totaling $226.7 million, supported by over $200 million raised through financing transactions in the latter half of the year [2][5] - The company maintains a strong equity position with a debt-to-equity ratio of 0.010 and a robust current ratio of 7.24 [4] Clinical Development - Invivyd is advancing its DECLARATION Phase 3 pivotal clinical trial for VYD2311, a vaccine-alternative antibody aimed at preventing COVID-19 [3][5] - The trial has received Fast Track designation from the FDA, with top-line data expected by mid-2026 [3] - The trial has reached full enrollment, and the Independent Data Monitoring Committee (IDMC) has recommended the inclusion of pregnant and breastfeeding women [3] Valuation Metrics - The company has a price-to-earnings (P/E) ratio of approximately -5.61, indicating negative earnings [4] - Its price-to-sales ratio is about 4.25, suggesting investors are willing to pay $4.25 for every dollar of sales [4] - The enterprise value to sales ratio is low at 0.052, which may imply undervaluation relative to its sales [4]

Financial Data and Key Metrics Changes - Invivyd's net revenues for Q4 2025 increased by 31% compared to Q3 2025 and by 25% compared to Q4 2024, totaling $53.4 million for the full year 2025 [26] - The company ended the year with $226.7 million in cash and cash equivalents, positioning it well for upcoming pivotal data for VYD2311 in mid-2026 [26] Business Line Data and Key Metrics Changes - The commercial work with PEMGARDA showed growth in Q4, establishing a foundation for broader commercialization of VYD2311 if approved [5] - The company reported a high reorder rate of 77% for PEMGARDA, indicating strong ongoing demand [24] Market Data and Key Metrics Changes - There is a growing recognition of monoclonal antibodies in the medical community, with leading organizations recommending their use for high-risk patients [22] - The company has secured over 15,000 contracted GPO sites, significantly expanding its commercial footprint [24] Company Strategy and Development Direction - Invivyd aims to redefine COVID prevention with its next-generation monoclonal antibody, moving towards a vaccine alternative strategy [25] - The company is focusing on expanding its portfolio to include treatments for other infectious diseases, such as RSV and measles, indicating a broader strategic vision [8][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for VYD2311 to provide effective protection against symptomatic COVID-19 [18] - The company is optimistic about the speed of study recruitment and the potential for robust assessment of VYD2311's effectiveness [20] Other Important Information - Invivyd is conducting its third randomized placebo-controlled trial for a COVID monoclonal antibody, which is designed to adapt to virus evolution [14] - The company is exploring the use of monoclonal antibodies for long COVID and post-vaccination syndrome, highlighting its commitment to addressing unmet medical needs [7] Q&A Session Summary Question: Can you elaborate on the potential trial resizing decision in the DECLARATION program? - Management indicated that the resizing decision would depend on the expected vaccine efficacy and the number of events accumulated, with a potential upsizing target of approximately 30% [29][30] Question: Are secondary endpoints being collected in the trial? - Management confirmed that various interactions, including healthcare utilization, would be recorded, but cautioned against expecting meaningful powering of low-frequency clinical events [34][35] Question: What is the envisioned use case for the measles antibody program? - Management highlighted potential use cases for outbreak prophylaxis and pediatric bridge therapy, emphasizing the antibody's design to address specific medical needs [37][41] Question: How is the DECLARATION study configured to target areas with high COVID rates? - Management explained that the study sites are strategically located in areas with community COVID attack rates, utilizing various data sources to inform site selection [46][48] Question: What is the approach to monitoring myocarditis in the study? - Management stated that the monitoring would primarily focus on clinical myocarditis events, with the possibility of further exploration if such events occur [50][51] Question: How does Invivyd plan to compete in the RSV antibody market? - Management expressed confidence in their antibody's properties and the potential to address evolutionary drift, positioning it as a competitive option in the RSV market [56][58]

Financial Data and Key Metrics Changes - Invivyd's net revenues for PEMGARDA grew by 31% compared to Q3 2025 and by 25% compared to Q4 2024, totaling $53.4 million for the full year 2025 [26] - The company ended 2025 with $226.7 million in cash and cash equivalents, positioning it well for upcoming pivotal data for VYD2311 in mid-2026 [26] Business Line Data and Key Metrics Changes - The commercial activities for PEMGARDA are showing growth, establishing a foundation for broader commercialization of VYD2311 if approved [5][6] - The company is expanding its commercial footprint with over 15,000 contracted GPO sites, indicating a strong market presence [24] Market Data and Key Metrics Changes - There is a growing recognition among healthcare professionals of the importance of monoclonal antibodies for COVID prevention, as reflected in clinical guidelines from leading organizations [22][23] - The adoption curve for antibody therapy is expanding, particularly in specialties such as hematology, oncology, and infectious diseases [23] Company Strategy and Development Direction - Invivyd is focusing on redefining COVID prevention with its next-generation monoclonal antibody, moving towards a vaccine alternative strategy [25] - The company is also exploring clinical applications for long COVID and post-vaccination syndrome, indicating a strategic expansion into new therapeutic areas [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for VYD2311 to provide effective protection against symptomatic COVID-19 [18][21] - The company is optimistic about the speed of study recruitment and the potential for robust assessment of VYD2311's effectiveness [18] Other Important Information - The company has appointed Michael Mina as Chief Medical Officer, which may enhance its clinical and strategic capabilities [4] - The DECLARATION clinical trial for VYD2311 has reached its target enrollment, with potential for modest over-enrollment [16] Q&A Session Summary Question: Potential trial resizing decision in the DECLARATION program - Management indicated that the resizing decision would depend on the expected vaccine efficacy and the number of events accumulated, with a potential upsizing target of approximately 30% [29][30][31] Question: Secondary endpoints being collected in the trial - Management confirmed that various interactions, including healthcare utilization, would be recorded, but cautioned against expecting meaningful powering of low-frequency clinical events [34][36] Question: Update on the measles antibody program - Management discussed potential use cases for the measles antibody, including outbreak prophylaxis and pediatric bridge therapy, emphasizing the need for innovative solutions in this area [37][38][42] Question: Myocarditis monitoring in the study - Management clarified that myocarditis monitoring would primarily be a yes/no exercise, with the possibility of further exploration if events occur [50][51] Question: Competition in the RSV antibody market - Management expressed confidence in their RSV antibody's competitive properties and the potential for success in a market that is still evolving [56][58]

Financial Data and Key Metrics Changes - Invivyd's net revenues for Q4 2025 increased by 31% compared to Q3 2025 and by 25% compared to Q4 2024, totaling $53.4 million for the full year 2025 [25] - The company ended the year with $226.7 million in cash and cash equivalents, positioning it well for upcoming pivotal data for VYD2311 in mid-2026 [25] Business Line Data and Key Metrics Changes - The commercial activities with PEMGARDA showed growth in Q4, establishing a foundation for broader commercialization of VYD2311 if approved [5] - The company reported a high reorder rate of 77% for PEMGARDA, indicating strong ongoing demand [23] Market Data and Key Metrics Changes - There is a growing recognition among healthcare professionals of the importance of monoclonal antibodies for COVID prevention, as reflected in clinical guidelines from leading organizations [22] - Invivyd has secured over 15,000 contracted GPO sites, significantly expanding its commercial footprint [23] Company Strategy and Development Direction - Invivyd aims to redefine COVID prevention with its next-generation monoclonal antibody, moving towards a vaccine alternative strategy [24] - The company is focusing on expanding its portfolio to include treatments for other infectious diseases, such as RSV and measles, which could enhance its market presence [8][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for VYD2311 to provide effective protection against symptomatic COVID-19 [20] - The company is closely monitoring the evolving COVID landscape and is prepared to adapt its strategies based on community infection rates [46] Other Important Information - The DECLARATION clinical trial for VYD2311 has reached its target enrollment, with the potential for modest over-enrollment [16] - The company is excited about the potential of its RSV antibody, which is designed to compete with existing treatments in the market [54] Q&A Session Summary Question: Can you elaborate on the potential trial resizing decision in the DECLARATION program? - Management indicated that resizing would depend on the expected vaccine efficacy and the number of events accumulated, with a potential upsizing target of approximately 30% [30][31] Question: Are secondary endpoints being collected in the DECLARATION study? - Management confirmed that various interactions, including healthcare utilization, will be recorded, although they cautioned against expecting meaningful powering for low-frequency clinical events [33][36] Question: What is the envisioned use case for the measles antibody program? - Management highlighted potential use cases including outbreak prophylaxis and pediatric bridge therapy, emphasizing the need for innovative solutions in pediatric care [37][39] Question: How is the DECLARATION study being configured to target areas with high COVID rates? - Management explained that they are utilizing community data to place study sites in areas with higher COVID attack rates, although they acknowledged the challenges of rapidly changing conditions [46] Question: What is the monitoring plan for myocarditis in the LIBERTY study? - Management stated that the monitoring will primarily be a yes/no exercise for overt myocarditis, with the possibility of further exploration if events occur [48]

Invivyd Q4 Earnings Call & Business Update March 5, 2026 © 2026 Invivyd, Inc. All trademarks used in this presentation are the property of their respective owners. 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "p ...

Core Insights - Invivyd, Inc. reported strong financial results for Q4 and full year 2025, with significant revenue growth and reduced operating expenses, highlighting the potential commercialization of VYD2311 and ongoing clinical trials [2][4][12]. Financial Performance - Q4 2025 net product revenue from PEMGARDA reached $17.2 million, a 25% increase year-over-year and a 31% increase quarter-over-quarter [4][12]. - Full year 2025 net product revenue totaled $53.4 million, compared to $25.4 million in 2024 [12]. - Cash and cash equivalents at year-end 2025 were $226.7 million, bolstered by over $200 million raised in financing during the second half of 2025 [4][12]. - Research and Development (R&D) expenses decreased to $38.3 million in 2025 from $137.3 million in 2024, primarily due to lower contract research costs [12]. - Selling, General & Administrative (SG&A) expenses increased to $66.9 million in 2025 from $63.4 million in 2024, attributed to higher personnel-related costs [12]. - The net loss for 2025 was $52.5 million, significantly reduced from $169.9 million in 2024, with a net loss per share of $0.30 compared to $1.43 in the previous year [12][36]. Clinical and Regulatory Developments - The DECLARATION Phase 3 pivotal clinical trial for VYD2311 has achieved full enrollment, with top-line data expected in mid-2026 [4][5]. - The FDA granted Fast Track designation for VYD2311 in December 2025, facilitating expedited development and review processes [5][7]. - The Independent Data Monitoring Committee (IDMC) recommended allowing pregnant and breastfeeding women to enroll in the DECLARATION trial after reviewing unblinded safety data [5]. - The LIBERTY Phase 3 clinical trial will assess the safety and immunologic profile of VYD2311 compared to mRNA COVID vaccines, with specific monitoring for adverse events of interest [5][7]. Pipeline Expansion - Invivyd is advancing its pipeline with VBY329, a monoclonal antibody candidate for the prevention of Respiratory Syncytial Virus (RSV) in children, expected to enter IND readiness in the second half of 2026 [7][12]. - The company is also planning a Phase 2 clinical trial for VYD2311 in individuals with Long COVID or COVID vaccine injury, anticipated to start by mid-2026 [7]. Corporate Updates - Michael Mina, M.D., Ph.D., has been appointed as Chief Medical Officer, indicating a strategic move to enhance clinical leadership [12]. - Invivyd is launching a national multimedia educational campaign in partnership with Lindsey Vonn to raise public awareness about the role of antibodies in disease prevention [12].

Core Viewpoint - Invivyd, Inc. has received guidance from the U.S. FDA regarding the LIBERTY Phase 3 clinical trial for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19, which will compare its safety and immunologic profile against mRNA COVID vaccines [1][2][5] Group 1: LIBERTY Trial Overview - The LIBERTY trial will assess the safety and immunologic profile of VYD2311 compared to commercially available mRNA COVID vaccines, including the simultaneous administration of both [1][5] - The trial is designed to provide insights into the safety and tolerability of monoclonal antibody-mediated prophylaxis versus mRNA vaccines, building on the previous DECLARATION trial [2][5] - Total enrollment for the LIBERTY trial is expected to be around 210 participants [7] Group 2: Background on VYD2311 - VYD2311 is a novel monoclonal antibody candidate developed to address the need for new COVID-19 prevention options, with a focus on delivering effective titer levels through intramuscular administration [4][6] - The antibody was engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [6] Group 3: Regulatory Context and Safety Monitoring - The FDA has requested specific monitoring for adverse events of special interest, particularly myocarditis and pericarditis, in the LIBERTY trial due to concerns raised during the COVID pandemic regarding mRNA vaccines [2][5] - No similar monitoring requests have been made for other Invivyd trials that do not include an mRNA vaccine arm [2][5] Group 4: DECLARATION Trial Details - The DECLARATION trial is a Phase 3, randomized, triple-blind, placebo-controlled study evaluating the efficacy and safety of VYD2311 in preventing symptomatic COVID-19, with an expected enrollment of 1770 participants [3][8] - Participants will receive either a single or monthly dose of VYD2311 via intramuscular injection, compared to a placebo [3][8]

Core Viewpoint - Invivyd, Inc. and the SPEAR Study Group are set to initiate a Phase 2 clinical trial for the monoclonal antibody VYD2311, targeting individuals suffering from Long COVID or COVID vaccine injury, addressing a significant unmet medical need in the U.S. [1][2] Group 1: Clinical Trial Details - The Phase 2 clinical trial is expected to start by mid-2026 and will evaluate the safety, translational biology, and exploratory clinical efficacy of VYD2311 in individuals with Long COVID or COVID vaccine injury [4][5] - Participants will include those with Long COVID showing evidence of chronic infection or antigen persistence, as well as individuals injured by COVID vaccines [4] - The trial design includes administering multiple high doses of VYD2311 over the long term to assess safety and potential clinical benefits compared to a placebo [4][5] Group 2: Scientific Rationale - Data indicates that prolonged presence of spike protein antigen may contribute to ongoing morbidity in individuals with Long COVID and those experiencing chronic conditions post-vaccination [2] - The SPEAR Study Group was formed to advance understanding of Long COVID and explore potential therapeutic options, with Invivyd's monoclonal antibodies seen as promising candidates [2][3] Group 3: Product Information - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, demonstrating in vitro antiviral activity against all clinically recorded variants of SARS-CoV-2 [6][7] - The antibody was engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [7] - VYD2311 aims to deliver clinically meaningful titer levels through more patient-friendly administration methods, such as intramuscular injection [6]

Group 1 - Invivyd, Inc. reported preliminary fourth-quarter 2025 net product revenue of $17.2 million from PEMGARDA, reflecting a 25% year-over-year growth and a 31% increase from the previous quarter [1][2] - The company ended 2025 with $226.7 million in cash and equivalents, supported by financing completed in the second half of the year, and has a current ratio of 2.47, indicating strong liquidity for operations and pipeline advancement [1][3] - Invivyd has launched the DECLARATION Phase 3 pivotal trial for VYD2311, a monoclonal antibody for COVID-19 prevention, which received FDA Fast Track designation in December 2025, with top-line results expected by mid-2026 [2][3] Group 2 - The company is expanding its pipeline beyond COVID-19, with VBY329, an RSV antibody candidate expected to reach IND readiness in late 2026, and a measles antibody program in preclinical development with candidate selection planned for early 2026 [3][4] - PEMGARDA has a gross margin of 93.3%, highlighting its commercial potential in the market [2]