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Adagio(IVVD) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:32
Financial Data and Key Metrics Changes - Invivyd's Pemgarda revenues grew by 11% quarter on quarter and 41% year over year, reflecting ongoing market awareness efforts [18] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position to support pivotal clinical programs and commercial expansion [5][18] Business Line Data and Key Metrics Changes - The commercial franchise for Pemgarda is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion, with 76% of those accounts reordering [13][14] - The company is transitioning from a smaller patient population to a broader market opportunity with the anticipated launch of VYD2311 [13][15] Market Data and Key Metrics Changes - COVID vaccine sales in the U.S. totaled $3.8 billion last year, indicating a significant market opportunity for Invivyd's products [17] - Current COVID vaccine uptake is substantially below that of influenza vaccines, despite higher public concern about COVID [16] Company Strategy and Development Direction - Invivyd aims to provide a widely available option for COVID prevention, addressing the limitations of current vaccines and focusing on the safety and efficacy of its antibody-based therapies [15][17] - The company is preparing for the launch of VYD2311, with pivotal data expected in mid-2026, and is actively engaging with healthcare providers to expand its market reach [12][18] Management's Comments on Operating Environment and Future Outlook - Management views the next 12 to 18 months as a critical period for Invivyd, with expectations for significant advancements in COVID prevention strategies [7] - The company is focused on demonstrating the safety and efficacy of VYD2311 compared to existing vaccines, addressing public concerns about vaccination safety [11][12] Other Important Information - Invivyd is conducting pivotal studies (Declaration and Liberty) to gather comprehensive data on the efficacy and safety of VYD2311, which could reshape COVID prevention strategies [10][12] - The company is also exploring early-stage discovery efforts in RSV and measles, with plans for rapid advancement into clinical development [30][32] Q&A Session Summary Question: Will Invivyd wind down Pemgarda once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset Pemgarda, as it remains a differentiated medicine despite its scalability challenges [21] Question: Can you clarify the coordination between CBR and CDR for the Liberty study? - Management indicated that coordination between CBER and CDER is expected, but specific details would be best addressed by the FDA [23][25] Question: What are the commercial team's current reach and plans for expansion beyond infusion centers? - The commercial team is building upon its foundation to reach specialists caring for immunocompromised patients and plans to enhance digital outreach and field presence [29] Question: How does Invivyd intend to differentiate its early-stage discovery efforts in RSV and measles? - Management explained that differentiation will focus on resistance profiles and biophysical properties, with updates expected before the end of the year [30][32]
Adagio(IVVD) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:32
Financial Data and Key Metrics Changes - Invivyd's PEMGARDA revenues grew by 11% quarter-on-quarter and 41% year-over-year, reflecting ongoing market awareness efforts [19] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position for upcoming clinical programs [5][19] Business Line Data and Key Metrics Changes - The commercial franchise for PEMGARDA is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion services, with 76% of those accounts reordering [14][15] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, aiming to replace current vaccine options [14][18] Market Data and Key Metrics Changes - COVID vaccine sales in the U.S. totaled $3.8 billion last year, indicating a significant market opportunity for Invivyd's products [18] - Current COVID vaccine uptake is substantially below that of influenza vaccines, despite higher public concern about COVID [17] Company Strategy and Development Direction - Invivyd is focused on advancing its next-generation antibody, VYD2311, which aims to provide a safer and more effective alternative to current COVID vaccines [4][18] - The company plans to initiate pivotal clinical studies for VYD2311 around year-end 2025, with top-line data expected in mid-2026 [7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming 12-18 months, highlighting the potential for significant advancements in COVID prevention for vulnerable populations [7] - The company aims to address safety concerns associated with COVID vaccines through its antibody-based approach, which is expected to have a favorable side effect profile [12][13] Other Important Information - The DECLARATION and LIBERTY studies are designed to provide critical data on the efficacy and safety of VYD2311 compared to existing vaccines [10][13] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, with plans for rapid advancement into clinical development [31][33] Q&A Session Summary Question: Will Invivyd wind down PEMGARDA once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset PEMGARDA, as it remains a differentiated medicine despite its scalability challenges [22] Question: Can you clarify the coordination between CBER and CDER for the LIBERTY study? - Management indicated that coordination between CBER and CDER is expected due to the unique nature of the study, but specific details are best addressed by the FDA [24][26] Question: What are the commercial team's current reach and plans for expansion? - The commercial team is building upon its foundation in infusion centers and plans to expand its reach through digital assets and increased field presence [30] Question: How does Invivyd intend to differentiate its early-stage discovery programs in RSV and measles? - Management highlighted the focus on viral resistance and biophysical properties as key differentiation factors for the new antibody programs [32][33]
Adagio(IVVD) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:30
Financial Data and Key Metrics Changes - Invivyd reported a significant increase in Pemgarda revenues, which grew by 11% quarter on quarter and 41% year over year, reflecting ongoing market awareness efforts [18] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position to support pivotal clinical programs and commercial expansion [5][18] Business Line Data and Key Metrics Changes - The Pemgarda commercial franchise is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion, with 76% of those accounts reordering [13][14] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, which is expected to replace vaccines for COVID prevention [12][17] Market Data and Key Metrics Changes - The U.S. COVID vaccine market generated $3.8 billion in sales last year, but vaccine uptake remains lower than that of influenza vaccines, despite higher public concern about COVID [17] - The company sees a significant opportunity to improve safety and efficacy in COVID protection compared to existing vaccines, which may enhance market share if VYD2311 is approved [17] Company Strategy and Development Direction - Invivyd is focused on advancing its next-generation antibody, VYD2311, which aims to provide a safer and more effective alternative to current COVID vaccines [4][11] - The company is preparing for pivotal studies, with data expected in mid-2026, and is committed to maintaining operational discipline while expanding its commercial organization [5][11][18] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of addressing the long-term efficacy and safety of COVID vaccines, noting the lack of modern randomized data on vaccine effectiveness [9][10] - The next 12 to 18 months are anticipated to be transformative for Invivyd, with a strong focus on clinical trials and potential market entry for VYD2311 [6][11] Other Important Information - The company is conducting studies to evaluate the safety and efficacy of VYD2311, including a head-to-head comparison with mRNA vaccines to address safety concerns among the public [10][11] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, aiming to differentiate its products in these markets [29][30] Q&A Session Summary Question: Will Invivyd wind down Pemgarda once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset Pemgarda, as it remains a differentiated medicine despite its scalability challenges [20][21] Question: Can you clarify the coordination between CBR and CDR for the Liberty study? - Management indicated that coordination between CBER and CDER is expected, but specific details would be best addressed by the FDA [22][23][25] Question: What are the commercial team's current reach and plans for expansion beyond infusion centers? - The commercial team is building upon its foundation to reach specialists caring for immunocompromised patients and plans to increase digital outreach and field presence [27][28] Question: How will Invivyd differentiate its early-stage discovery efforts in RSV and measles? - Management explained that differentiation will focus on resistance profiles and biophysical properties, with updates expected before the end of the year [29][30][32]
Adagio(IVVD) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:30
Invivyd Q3 Earnings Call & Business Update November 6, 2025 © 2025 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," ...
Adagio(IVVD) - 2025 Q3 - Quarterly Report
2025-11-06 12:16
Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA® (pemivibart) on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in adults and adolescents [171]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, which is expected to support revenue generation [196]. Financial Performance - The company reported a net loss of $41.4 million for the nine months ended September 30, 2025, with an accumulated deficit of $943.4 million as of the same date [183]. - The net loss for the three months ended September 30, 2025, was $10.5 million, a decrease of $50.3 million from a net loss of $60.7 million in the same period of 2024 [204]. - Total revenue for the nine months ended September 30, 2025, was $36.2 million, compared to $11.6 million for the same period in 2024, reflecting an increase of $24.6 million [215]. - The company reported a net loss of $41.4 million for the nine months ended September 30, 2025, compared to a net loss of $151.5 million for the same period in 2024, a decrease of $110.1 million [212]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $42.7 million, compared to $132.9 million for the same period in 2024 [234]. Research and Development - The Phase 1/2 clinical trial for VYD2311, a next-generation monoclonal antibody candidate for COVID-19, began in September 2024, with positive safety and pharmacokinetics data announced in June 2025 [172]. - The DECLARATION clinical trial, a pivotal Phase 3 trial for VYD2311, is expected to begin around the end of 2025, with top-line data anticipated in mid-2026 [174]. - Invivyd, Inc. aims to develop monoclonal antibodies for serious viral diseases, starting with COVID-19 and potentially expanding to other high-need indications [176]. - The company has engaged in active SARS-CoV-2 variant monitoring, reporting continued neutralizing activity of PEMGARDA against various variants [178]. - The SPEAR Study Group was formed in July 2025 to evaluate the effects of broadly neutralizing anti-SARS-CoV-2 monoclonal antibody therapy in patients suffering from Long COVID or Post-Vaccination Syndrome [175]. - The company plans to continue the commercialization of PEMGARDA and advance the development of VYD2311, along with conducting clinical trials for its product candidates [186]. - The company has initiated discovery efforts to expand its pipeline beyond SARS-CoV-2, targeting potential new indications such as respiratory syncytial virus and measles [191]. - Research and development expenses significantly decreased to $8.0 million in Q3 2025 from $57.9 million in Q3 2024, a reduction of $49.8 million [204]. - Research and development expenses for the nine months ended September 30, 2025, were $28.3 million, down from $119.3 million in 2024, a decrease of $91.0 million [219]. Expenses and Costs - Cost of product revenue was $1.1 million for the three months ended September 30, 2025, up from $0.8 million in 2024, resulting in a $0.3 million increase attributed to higher PEMGARDA sales [206]. - Selling, general and administrative expenses rose to $15.0 million in Q3 2025, compared to $13.0 million in Q3 2024, an increase of $2.1 million [204]. - The cost of product revenue was $2.6 million for the nine months ended September 30, 2025, compared to $0.9 million in 2024, an increase of $1.7 million [216]. Financing and Capital - Invivyd, Inc. has raised a total of $464.7 million from preferred stock sales, $327.5 million from its IPO, and $43.8 million from common stock sales under a Sales Agreement [182]. - The company had cash and cash equivalents of $85.0 million as of September 30, 2025 [223]. - The company financed operations primarily with net proceeds of $464.7 million from sales of preferred stock and $327.5 million from its IPO in August 2021 [222]. - The company generated $58.5 million from financing activities during the nine months ended September 30, 2025, compared to $39.3 million in the same period in 2024 [239]. - In October 2025, the company sold 18,655,402 shares at an average price of $1.60 per share, generating $28.9 million in proceeds [229]. - The company completed an underwritten public offering in August 2025, issuing 89,234,480 shares at $0.52 per share, raising approximately $53.5 million in net proceeds [231]. - The company entered into a Loan Agreement for a senior secured term loan facility of up to $30 million, with specific drawdown conditions based on revenue milestones [232]. Going Concern and Future Plans - The company has substantial doubt about its ability to continue as a going concern beyond one year from the issuance date of its financial statements, based on current operating plans [187]. - The company plans to finance operations through a combination of revenue contributions, equity offerings, and debt financing, which may dilute existing stockholders' interests [243]. - The company is committed to advancing the REVOLUTION clinical program for VYD2311 and other product candidates, impacting future funding requirements [241]. Compliance and Reporting - The company is exempt from compliance with the auditor attestation requirement in the assessment of internal control over financial reporting [251]. - The company has reduced disclosure obligations regarding executive compensation [251]. - The company is exempt from holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved [251]. - The company is exempt from compliance with the Public Company Accounting Oversight Board requirements regarding the communication of critical audit matters in the auditor's report on financial statements [251]. - The company qualifies as a smaller reporting company and is not required to provide certain market risk disclosures [252].
Adagio(IVVD) - 2025 Q3 - Quarterly Results
2025-11-06 12:10
Exhibit 99.1 Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights NEW HAVEN, Conn., Nov. 06, 2025 – Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the quarter ended September 30, 2025, and provided recent business highlights. "With a strengthened balance sheet and a clear path forward for VYD2311 with recent IND clearance and U.S. Food and Drug Administration (FDA) alignment, Invivyd is well-poised to provide Americans with antibody protection as an alterna ...
Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Globenewswire· 2025-11-06 12:01
Core Insights - Invivyd, Inc. reported strong financial results for Q3 2025, with a net product revenue of $13.1 million, reflecting a 41% year-over-year growth and an 11% quarter-over-quarter growth [5][10] - The company is preparing for pivotal studies and a potential commercial launch of VYD2311, an antibody alternative to COVID vaccination, following recent IND clearance and FDA alignment [2][4] - Invivyd's cash position improved significantly, ending Q3 2025 with $85 million in cash and cash equivalents, bolstered by a public offering and ATM facility [5][10] Recent Business Highlights - The company is focused on the urgent need for antibody protection against COVID-19 and is also exploring additional pathogens beyond COVID [2][3] - The REVOLUTION clinical program for VYD2311 includes two pivotal trials: DECLARATION and LIBERTY, expected to begin around year-end 2025, with top-line data anticipated by mid-2026 [5][6][7] Clinical & Regulatory Developments - Invivyd received U.S. IND clearance for VYD2311, which is designed to prevent COVID-19, and is preparing for the initiation of the DECLARATION and LIBERTY clinical trials [5][6] - The DECLARATION trial will evaluate the safety and efficacy of VYD2311 in preventing symptomatic COVID-19, while the LIBERTY trial will assess its interaction with mRNA-based COVID vaccines [6][7] Commercial Execution - The uptake of PEMGARDA (pemivibart) continues to grow among healthcare providers, supported by Invivyd's sales force [6] - Positive in vitro neutralization data for PEMGARDA and VYD2311 against the XFG variant of SARS-CoV-2 was announced, indicating no significant change in neutralization activity [6][8] Corporate and Financial Updates - The company reported a net loss of $10.5 million for Q3 2025, a significant reduction from a net loss of $60.7 million in Q3 2024 [10][27] - Research and development expenses decreased to $8 million in Q3 2025 from $57.9 million in the same period of 2024, primarily due to reduced clinical trial costs [10][27] Pipeline Expansion - Invivyd is initiating discovery efforts to expand its pipeline beyond SARS-CoV-2, targeting potential pathogens such as respiratory syncytial virus (RSV) and measles [8][9]
Invivyd to Host Third Quarter 2025 Financial Results and Corporate Update Call on November 6, 2025
Globenewswire· 2025-11-03 21:01
Core Viewpoint - Invivyd, Inc. will host a conference call on November 6, 2025, to discuss its third quarter 2025 financial results and provide a corporate update [1]. Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, starting with SARS-CoV-2 [3]. - The company utilizes a proprietary integrated technology platform designed to assess, monitor, develop, and adapt to create best-in-class antibodies [3]. - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline of innovative antibody candidates [3].
Invivyd, Inc. (IVVD) Discusses REVOLUTION Clinical Program and Development of VYD2311 Antibody for COVID Prevention Transcript
Seeking Alpha· 2025-10-31 03:36
Core Points - The conference call is part of Invivyd's REVOLUTION Pivotal Program, indicating a significant development in their research and clinical activities [1] - Key speakers include Marc Elia, Dr. Robert Allen, Dr. Mark Wingertzahn, and Tim Lee, highlighting the involvement of senior leadership in the discussion [2] - The call will include forward-looking statements regarding research, regulatory plans, and corporate strategy, which are subject to various risks and uncertainties [3] Summary by Sections Company Overview - Invivyd is conducting a pivotal program, suggesting a focus on advancing their clinical development efforts [1] - The leadership team participating in the call includes the Chairman, Chief Scientific Officer, Senior VP of Clinical Development, and Chief Commercial Officer, indicating a comprehensive approach to the discussion [2] Research and Development - The discussion will cover research and development activities, emphasizing the company's commitment to innovation and future prospects [3] Regulatory and Commercial Strategy - Forward-looking statements will address regulatory plans and corporate strategy, reflecting the company's strategic direction and potential market positioning [3]
Invivyd (NasdaqGM:IVVD) Update / Briefing Transcript
2025-10-30 13:30
Summary of Invivyd Revolution Pivotal Program Conference Call Company Overview - **Company**: Invivyd - **Product**: VYD2311, an antibody developed as an alternative to COVID vaccination and for other potential uses Key Industry Insights - **COVID Landscape**: The current and future endemic COVID situation is still evolving, with significant systemic medical implications beyond respiratory symptoms, including cardiovascular and organ damage [9][10] - **Vaccine Efficacy**: Initial COVID vaccines showed short-term efficacy, but long-term protection has been questioned due to the evolving nature of the virus and the limitations of the human immune response [10][12] Core Points and Arguments - **Antibody Technology**: Invivyd focuses on developing antibodies that enhance human immune responses, aiming for a best-in-class safety and efficacy profile [6][7] - **Expansion Beyond COVID**: The company is exploring treatments for acute COVID, long COVID, and other viral pathogens like RSV and measles [7] - **Clinical Trials**: The Revolution Program includes a Phase 1/2 study and a Phase 3 randomized placebo-controlled study (Declaration) to assess VYD2311's efficacy in preventing symptomatic COVID-19 [29][34] - **Efficacy Expectations**: The Declaration study aims for a 70% to 90% reduction in symptomatic COVID-19 compared to placebo over a 90-day period [36][64] Important Data and Projections - **Commercial Opportunity**: U.S. COVID vaccine sales totaled $3.8 billion last year, with lower uptake compared to influenza vaccines, indicating a significant market opportunity for VYD2311 [46][74] - **Safety Profile**: VYD2311 has shown a favorable safety profile even at suprapharmacologic doses, with no significant adverse findings in preclinical testing [31][33] Additional Considerations - **Public Perception**: There is a notable fear and mistrust regarding COVID vaccination among the public, which presents an opportunity for Invivyd to restore trust through its antibody solutions [13][14] - **Regulatory Coordination**: The Liberty study will assess the safety and tolerability of mRNA vaccines versus VYD2311, which may inform future labeling and guidance for healthcare providers [42][43] - **Manufacturing and Delivery**: Invivyd is confident in its manufacturing capabilities to meet potential demand for VYD2311, which is designed for easy administration [90] Conclusion - Invivyd is positioned to offer a novel solution in the COVID landscape with VYD2311, focusing on safety, efficacy, and addressing public concerns about vaccination. The company is actively preparing for clinical trials and commercial opportunities while navigating regulatory landscapes.