If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...

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 ...

Financial Agreements and Payments - The company made aggregate payments of $0.2 million to WuXi Biologics under the Cell Line License Agreement through December 31, 2025[102]. Competition and Market Landscape - The company faces competition from major pharmaceutical and biotechnology companies with significantly greater financial resources and expertise in R&D, clinical trials, and commercialization[104]. - The company is competing in the RSV prevention market, where existing options are limited to protein-based vaccines from Pfizer and GSK, and an mRNA vaccine from Moderna[107]. Intellectual Property - The company holds one patent family with three issued U.S. patents related to broadly neutralizing anti-coronavirus antibodies, expected to expire in 2041[113]. - Another patent family directed to formulations and methods of use for ADG20 is pending, with expected expiration in 2042[114]. - The company has filed trademark applications for marks including INVIVYD, PEMGARDA, and INVYMAB, with registrations issued in multiple countries[119]. - The company relies on trade secrets to protect proprietary information and technology, with confidentiality agreements in place[120]. FDA Regulations and Approval Process - The FDA requires extensive regulation for biologics, impacting the company's ability to develop and commercialize product candidates[121]. - The process for FDA approval involves completion of nonclinical tests, submission of an IND, and conducting well-controlled human clinical trials[122]. - The FDA requires submission of a Biologics License Application (BLA) that includes evidence of safety, purity, potency, and efficacy from nonclinical testing and clinical trials[127]. - Clinical trials are conducted in three phases, with Phase 3 typically involving several hundred to several thousand subjects to establish the overall risk-benefit ratio[133]. - The FDA aims to review and act on 90% of standard new molecular entity New Drug Applications and original BLAs within ten months after the 60-day filing date[136]. - The FDA may issue an approval letter authorizing commercial marketing or a complete response letter indicating deficiencies in the BLA[139]. - The FDA may require post-approval clinical trials, known as Phase 4 trials, to further assess a biological product's safety and effectiveness[140]. - The FDA has the authority to issue Emergency Use Authorizations (EUA) for unapproved medical products during public health emergencies[143]. - Sponsors must submit annual progress reports detailing clinical trial results to the FDA[129]. - The manufacturing process for biological products must comply with current Good Manufacturing Practices (cGMP) to ensure quality and safety[130]. - The FDA may impose clinical holds on trials due to safety concerns or non-compliance, which can delay the clinical trial process[129]. - Pediatric Study Plans (PSP) must be submitted within 60 days of an end-of-Phase 2 meeting for drugs with new active ingredients or indications[142]. - The FDA may issue an Emergency Use Authorization (EUA) if a serious condition exists, evidence of potential effectiveness is present, and no adequate alternatives exist[144]. - EUA holders are expected to submit full applications, such as a Biologics License Application (BLA), as soon as possible, with the EUA remaining in effect until the public health emergency ceases or the product's approval status changes[145]. - The FDA can revise or revoke an EUA if the conditions justifying its issuance no longer exist or if public health requires it[146]. - The FDA's authority to issue EUAs for COVID-19 products remains effective despite the expiration of the public health emergency declaration on May 11, 2023[149]. - Compliance with federal, state, and local regulations requires substantial time and financial resources, with ongoing FDA regulation of biological products after authorization or approval[150]. - Companies must comply with Good Manufacturing Practices (cGMP), and failure to do so may lead to enforcement actions by the FDA[151]. - After a BLA approval or EUA issuance, products may be subject to official lot release, requiring testing and submission of results to the FDA[152]. - The FDA has various expedited review programs, such as Fast Track and Breakthrough Therapy designations, to accelerate the development and review of products for serious conditions[161][163]. - Priority review designation can reduce the FDA's review timeline to six months for applications that meet specific criteria[164]. - The FDA's accelerated approval pathway allows biological products to receive approval based on clinical trials demonstrating effects on surrogate endpoints, potentially reducing the time to market for treatments addressing serious conditions[165]. Regulatory Framework and Market Exclusivity - The Biologics Price Competition and Innovation Act of 2009 established an abbreviated approval pathway for biosimilar products, requiring no clinically meaningful differences in safety, purity, and potency compared to reference products[167]. - Under the BPCIA, a reference biologic is granted 12 years of exclusivity from the time of first licensure, preventing competition from biosimilars during this period[168]. - The European Union provides eight years of data exclusivity and an additional two years of market exclusivity for new active substances, with potential extensions for new therapeutic indications[180]. - The EU's proposed Pharma Package includes a cap of 11 years on combined regulatory market protection and aims to reduce the evaluation timeframe for marketing authorization applications to 180 days[184]. - The centralized procedure in the EU allows for a single marketing authorization valid across all member states, with a maximum evaluation timeframe of 210 days, potentially reduced to 150 days for products of major public health interest[175]. - The mutual recognition procedure allows for marketing authorizations in multiple EU member states based on existing approvals in other states, streamlining the approval process[178]. - The Pediatric Investigation Plan (PIP) is mandatory for new medicinal products, ensuring data is collected for pediatric use, with incentives for compliance including extensions of supplementary protection certificates[183]. - The UK Medicines and Healthcare products Regulatory Agency (MHRA) regulates the medicinal products market in the UK, separate from EU regulations following Brexit[185]. - The United Kingdom's regulatory regime for clinical trials and marketing authorizations largely mirrors that of the European Union, with significant changes effective from January 1, 2025, under the Windsor Framework[187]. - The new single marketing authorization covers the entire United Kingdom, replacing previous separate licenses for Great Britain and Northern Ireland[187]. - The United Kingdom has introduced an expedited authorization procedure for applicants with prior approvals from specified reference regulators, enhancing the efficiency of the approval process[188]. Healthcare Reform and Economic Impact - Significant uncertainty exists regarding coverage and reimbursement for product candidates, with third-party payors determining coverage on a case-by-case basis[191]. - The Centers for Medicare & Medicaid Services (CMS) and state Medicaid programs play a crucial role in determining reimbursement levels, which can significantly impact product affordability for patients[191]. - The European Union's HTA Regulation, effective from January 12, 2025, will standardize health technology assessments across member states, influencing pricing and reimbursement decisions[197]. - Pharmaceutical companies face increasing barriers to entry in the European Union due to stringent pricing and reimbursement negotiations required for new products[195]. - The GDPR imposes strict obligations on the processing of personal data, with potential fines of up to €20 million or 4% of total worldwide annual turnover for non-compliance[200]. - The federal Anti-Kickback Statute and similar laws in the European Union impose severe penalties for violations, including substantial fines and imprisonment[198]. - The Foreign Corrupt Practices Act (FCPA) prohibits U.S. businesses from offering bribes to foreign officials, with similar anti-corruption laws applicable in other countries[200]. - The company expects future healthcare reform measures to potentially limit reimbursement amounts from governmental health benefit programs and commercial payors, impacting product demand[214]. - The Inflation Reduction Act of 2022 established a Medicare Part B inflation rebate scheme, requiring manufacturers to pay rebates if drug prices increase faster than inflation[208]. - The One Big Beautiful Bill Act is projected to decrease federal healthcare spending by approximately $1 trillion, affecting Medicaid spending and enrollment[210]. Workforce and Corporate Structure - As of February 1, 2026, the company had 122 full-time employees, with 16 holding Ph.D. or M.D. degrees and 35 engaged in research and development activities[215]. - The company operates a hybrid workforce, with approximately 34% of employees based in Massachusetts, 9% in Connecticut, 7% in California, and 7% in New Jersey[215]. - The company has a strong relationship with its employees, with no employees represented by labor unions or covered by collective bargaining agreements[215]. - The company’s human capital resources objectives focus on recruiting, retaining, and incentivizing a diverse and inclusive team[216]. - The company operates its corporate headquarters in New Haven, Connecticut, and a laboratory in Newton, Massachusetts, while also allowing remote work[217]. - The company rents office and laboratory space for administrative and research purposes, believing its hybrid approach meets ongoing needs[218]. - Legislative changes may result in increased scrutiny over drug pricing and reimbursement methodologies, potentially impacting the company's market conditions[212].

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].

Former assistant professor of epidemiology, immunology, and infectious disease at the Harvard T.H. Chan School of Public Health and pathology at Harvard Medical School and Brigham and Women’s Hospital, Dr. Mina strengthens Invivyd’s medical leadership Dr. Mina’s research at Harvard focused on antibodies, vaccines, and infectious diseases with special expertise in COVID-19, measles, and other diseases, and will be a significant asset to Invivyd and the advancement of its pipelineWith more than 100 scientific ...