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Invivyd, Inc. (IVVD) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2025-11-06 15:16
Core Insights - Invivyd, Inc. reported a quarterly loss of $0.06 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.05, marking a 20% earnings surprise [1] - The company's revenues for the quarter ended September 2025 were $13.13 million, missing the Zacks Consensus Estimate by 18.96%, compared to $9.3 million in the same quarter last year [2] - Invivyd's stock has increased approximately 243% since the beginning of the year, significantly outperforming the S&P 500's gain of 15.6% [3] Financial Performance - Over the last four quarters, Invivyd has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.05 on revenues of $19.3 million, and for the current fiscal year, it is -$0.43 on revenues of $58.6 million [7] Industry Context - Invivyd operates within the Zacks Medical - Biomedical and Genetics industry, which is currently ranked in the top 41% of over 250 Zacks industries [8] - The performance of stocks in this industry is influenced by the overall industry outlook, with top-ranked industries historically outperforming lower-ranked ones by a factor of more than 2 to 1 [8] Future Outlook - The sustainability of Invivyd's stock price movement will largely depend on management's commentary during the earnings call and the trends in earnings estimate revisions [3][4] - The estimate revisions trend for Invivyd was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6]
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 14:32
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 14:30
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]