Invivyd, Inc. (IVVD) is a biopharmaceutical company at the forefront of delivering protection against serious viral infectious diseases, with a primary focus on SARS-CoV-2. The company's proprietary INVYMAB platform combines state-of-the-art viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate new monoclonal antibodies (mAbs) to address evolving viral threats.
Invivyd's Journey and Accomplishments
Invivyd was incorporated in the State of Delaware in June 2020, with a mission to develop innovative solutions to combat the ongoing COVID-19 pandemic. The company has since made significant strides in advancing its pipeline of mAb candidates, anchored by its first authorized product, PEMGARDA (pemivibart).
Since its inception, Invivyd has devoted substantial resources to organizing and staffing, building an intellectual property portfolio, business planning, and conducting research and development. The company operates as a hybrid organization, with employees working at its corporate headquarters in Waltham, Massachusetts, and remotely.
In July 2020, Invivyd entered into a crucial Assignment and License Agreement with Adimab, LLC, which provided the company with coronavirus-specific antibodies and related intellectual property. This agreement laid the foundation for Invivyd's product candidate pipeline and accelerated its research efforts.
To further enhance its research capabilities, Invivyd expanded its team and secured dedicated laboratory space in Newton, Massachusetts in June 2022. This strategic move enabled the company to conduct internal discovery and development of monoclonal antibody candidates while continuing to leverage its partnership with Adimab.
In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for PEMGARDA, a half-life extended investigational mAb, for the pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised adults and adolescents. This landmark achievement marked the company's first regulatory success and a crucial step in its efforts to protect vulnerable populations from the ravages of SARS-CoV-2.
Building on the foundation laid by PEMGARDA, Invivyd continued to leverage its INVYMAB platform to nominate VYD2311, a next-generation mAb candidate, in January 2024. VYD2311 demonstrated high in vitro neutralization potency against prominent SARS-CoV-2 variants, including KP.3.1.1 and XEC, which together accounted for the majority of circulating variants in the U.S. as of late 2024. In September 2024, Invivyd announced the dosing of the first participants in a Phase 1 clinical trial of VYD2311, evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of the candidate across various routes of administration, including intramuscular and subcutaneous delivery.
Navigating Challenges and Maintaining Momentum
Despite the promising progress, Invivyd faced a notable challenge in the third quarter of 2024 when the FDA updated the PEMGARDA fact sheet to include a link to disputed, non-peer-reviewed neutralization data generated by an academic lab. This information created confusion among healthcare providers (HCPs) and patients, temporarily impacting PEMGARDA's commercial adoption. However, Invivyd swiftly responded by generating and providing the FDA with additional data from its own industrial-grade virology efforts, which demonstrated continued neutralizing activity of PEMGARDA against the relevant SARS-CoV-2 variants. The FDA subsequently re-issued an updated PEMGARDA fact sheet to reflect the accurate in vitro neutralization activity.
Undeterred by this setback, Invivyd remained focused on its mission to serve the immunocompromised community. The company continued to invest in its commercial infrastructure, forging partnerships with community and independent infusion centers, academic centers, and integrated delivery networks to increase access to PEMGARDA for the vulnerable population. Invivyd also bolstered its digital presence and conducted its first speaker program at the IDWeek conference, further amplifying awareness and education around the importance of COVID-19 protection for the immunocompromised.
Financial Performance and Outlook
Invivyd's financial performance has been marked by significant investments in research and development (R&D) to advance its pipeline, as well as ongoing commercialization efforts for PEMGARDA. For the nine months ended September 30, 2024, the company reported net product revenue of $11.6 million from PEMGARDA sales, with a gross profit margin of 86.7%.
In the third quarter of 2024, Invivyd generated $9.3 million in net product revenue from PEMGARDA sales. This represents a significant portion of the total $11.56 million in net product revenue for the nine months ended September 30, 2024, indicating a strong ramp-up in sales during the third quarter.
Research and development expenses have seen a substantial increase, reflecting Invivyd's commitment to advancing its pipeline. In the third quarter of 2024, R&D expenses reached $57.85 million, more than doubling from $25.57 million in the same period in 2023. For the nine months ended September 30, 2024, R&D expenses totaled $119.34 million, up from $96.39 million in the prior year period. This increase was primarily driven by the advancement of the VYD2311 program, which Invivyd nominated as a novel mAb therapeutic option for COVID-19 in the first quarter of 2024.
Despite the initial challenges, Invivyd remains confident in its ability to achieve near-term profitability. The company has substantial inventory on hand, which it expects will alleviate the need for significant manufacturing expenses in the near future. Additionally, Invivyd anticipates continued modest growth in net product revenue and various operational efficiency improvements to contribute to its path to profitability by the end of the first half of 2025.
As of September 30, 2024, Invivyd had cash and cash equivalents of $106,870,000, providing a solid financial foundation to support its ongoing R&D efforts, including the development of VYD2311, and its commercial operations. The company expects to finish 2024 with $65 million or more in cash and cash equivalents, demonstrating prudent cash management despite ongoing investments in R&D and commercialization.
However, it's important to note that as a pre-revenue biopharmaceutical company, Invivyd has faced significant financial challenges since its inception. The company has incurred substantial operating losses and negative cash flows, including a net loss of $151.5 million for the nine months ended September 30, 2024. In the most recent quarter, Invivyd reported a net loss of $60,739,000, with operating cash flow (OCF) of -$41,068,000 and free cash flow (FCF) of -$41,073,000. The decrease in net income, OCF, and FCF was primarily due to increased research and development expenses as the company continues to advance its product candidates through clinical development.
To fund its operations, Invivyd has primarily relied on proceeds from sales of convertible preferred stock, its initial public offering, and the sale of common stock. The company acknowledges that it will require additional funding in the future to support its continued operations and growth strategy.
Liquidity
Invivyd's liquidity position is crucial for its ongoing operations and future growth. The company's cash and cash equivalents of $106,870,000 as of September 30, 2024, provide a financial cushion for its near-term operational needs. However, given the company's history of operating losses and the capital-intensive nature of biopharmaceutical research and development, Invivyd will need to carefully manage its cash resources and potentially seek additional funding sources to ensure long-term financial stability.
The company's debt-to-equity ratio stands at 0.019636608506391217, indicating a relatively low level of debt compared to equity. This conservative capital structure provides Invivyd with financial flexibility and room for potential future borrowing if needed. The current ratio of 1.923824195971582 and quick ratio of 1.5792060298948334 suggest that the company has sufficient short-term assets to cover its near-term liabilities, further supporting its liquidity position.
Poised for the Future
Invivyd's unwavering commitment to addressing the evolving SARS-CoV-2 threat has positioned the company as a frontrunner in the fight against viral infectious diseases. The company's INVYMAB platform, which has demonstrated the ability to rapidly generate potent mAb candidates, coupled with its focus on serving the immunocompromised population, underscores Invivyd's strategic importance in the ongoing battle against COVID-19 and future viral challenges.
Despite the recent challenges, Invivyd has shown its resilience and adaptability, swiftly addressing regulatory concerns and refocusing its efforts on expanding access to PEMGARDA for those who need it most. With a robust pipeline, a strengthened commercial infrastructure, and a clear path to profitability, Invivyd is poised to continue making a meaningful impact in the lives of those affected by SARS-CoV-2 and other viral threats.
The company's guidance has evolved in response to recent events. Earlier in 2024, Invivyd had provided guidance of $150 million to $200 million in net product revenue for the year. However, this guidance was impacted by the FDA's late Q3 2024 warning about potential reduced activity of pemivibart (PEMGARDA) based on a contested third-party preprint. Despite this setback, Invivyd remains optimistic about its future performance. The company is targeting near-term profitability with existing cash, anticipated growth of net product revenue, and operational efficiency improvements. Invivyd expects to return to profitability by the end of June 2025, demonstrating confidence in its ability to overcome recent challenges and capitalize on the growing demand for COVID-19 prevention in immunocompromised populations.
As Invivyd continues to advance its pipeline, particularly the promising VYD2311 candidate, and expands its commercial reach for PEMGARDA, the company is well-positioned to navigate the evolving landscape of viral infectious diseases and deliver value to both patients and shareholders in the years to come.