Invivyd, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual report; the supplied filing text does not provide separate Q4-only financial results. The filing was signed March 28, 2024.
Business context
Invivyd is a biotechnology company developing monoclonal antibodies against viral diseases, initially focused on COVID-19. Its INVYMAB platform combines viral surveillance, predictive modeling and antibody engineering. PEMGARDA (pemivibart) received FDA emergency use authorization on March 22, 2024, after the fiscal year-end, for pre-exposure prevention of COVID-19 in certain immunocompromised adults and adolescents. The company reported no product revenue through December 31, 2023.
Financial performance and liquidity
| Metric | FY2023 / December 31, 2023 | FY2022 / December 31, 2022 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $158.7 million | $179.2 million |
| Selling, general and administrative expense | $49.1 million | $47.0 million |
| Total operating expenses | $212.8 million | $248.0 million |
| Operating loss | $212.8 million | $248.0 million |
| Net loss | $198.6 million; $1.81 per share | $241.3 million; $2.23 per share |
| Cash used in operating activities | $173.2 million | $220.0 million |
| Cash and cash equivalents | $200.6 million | $92.1 million |
| Total assets | $229.2 million | $383.2 million |
| Total liabilities | $51.7 million | $27.2 million |
Other income, mainly interest and accretion on investments, was $14.1 million in 2023 versus $6.7 million in 2022. Marketable securities were zero at year-end 2023, compared with $279.9 million at year-end 2022; cash increased partly as securities matured. The company reported no product sales, so gross margin is not applicable and the filing provides no product-margin results. No conventional borrowings are shown in the supplied balance sheet; reported lease liabilities totaled $2.2 million.
Management expects year-end 2023 cash, excluding revenue and external financing, to fund operations and capital expenditures into Q4 2024 and states that substantial doubt exists about the company’s ability to continue as a going concern. In February 2024, it sold 9.0 million shares under its at-the-market facility for $39.3 million net proceeds. This subsequent financing does not remove the stated going-concern uncertainty.
Material changes versus 2022
- Net loss narrowed by $42.7 million, while operating cash use declined by $46.8 million.
- R&D expense decreased $20.6 million, primarily as adintrevimab activity declined; spending shifted to VYD222, including its clinical and manufacturing work. The company prioritized VYD222 over NVD200 in 2023.
- SG&A rose $2.1 million, including higher personnel-related costs, partly offset by lower professional and consultant fees.
- 2022 included $17.4 million of non-cash warrant expense related to a warrant issued to Population Health Partners; no such expense was recorded in 2023.
- Cash and cash equivalents rose $108.6 million during 2023, substantially reflecting investment maturities and cash management, while total assets fell as marketable securities were converted to cash and consumed.
Outlook, risks and unusual items
- Commercial outlook: PEMGARDA’s EUA is for a defined, high-risk immunocompromised population; the company estimates approximately 485,000 people in the highest-risk U.S. group. It expected U.S. ordering to begin imminently after authorization and said it had secured supply for anticipated initial demand. Commercial uptake, reimbursement, demand and revenue were not yet demonstrated in FY2023.
- Pipeline: VYD222 showed positive initial CANOPY Phase 3 results announced in December 2023; the trial enrolled approximately 750 participants. The EUA followed in March 2024 and relied on immunobridging, including neutralizing titers against JN.1. VYD2311 was nominated in January 2024 and is expected to be the next candidate advanced to clinical development; timing and success are uncertain.
- Cash needs and manufacturing commitments: At December 31, 2023, $33.9 million of remaining non-cancelable commercial manufacturing purchase obligations to WuXi Biologics was expected to be paid in 2024, including $24.1 million already in accounts payable and accrued expenses. In Q1 2024, the company added $24.7 million of materials commitments and $50.3 million of commercial manufacturing commitments. It relies on WuXi as its sole CDMO, creating supply and execution concentration risk.
- Regulatory and product risks: PEMGARDA is authorized under an EUA, not approved, and its authorization could be revoked or affected by changes in circulating variants. The product has a boxed warning for anaphylaxis. Variant escape, uncertain immunobridging assumptions, safety, competition, reimbursement and the limited eligible population could constrain use and commercial prospects.
- Legal and governance: A securities class action concerning statements about adintrevimab and Omicron remained pending; the company says the outcome and potential impact cannot be assessed. The SEC notified the company in August 2023 that it did not intend to recommend action following its investigation. Adimab, a principal stockholder, is also a key licensing and research counterparty; certain directors have relationships with Population Health Partners, which received fees and a warrant.
- Other financial exposure: The company reported $318.6 million in federal NOL carryforwards and a full valuation allowance against net deferred tax assets. It has not assessed whether ownership changes could limit use of tax attributes.
Investor facts to verify
- Updated cash balance, quarterly cash burn and runway, incorporating the February 2024 ATM proceeds and PEMGARDA revenues and commercialization costs.
- Actual PEMGARDA orders, net sales, payer coverage and reimbursement, eligible-patient reach, and supply availability.
- FDA requirements for PEMGARDA’s continued EUA and any future pathway, and the durability of activity against circulating variants.
- VYD2311 clinical-development timing, CANOPY final data and any post-authorization safety or efficacy findings.
- WuXi manufacturing obligations, supply continuity and the implications of potential U.S. restrictions affecting the supplier.
- Developments in the securities class action and any resulting financial or operational exposure.