Overview of Financial Performance

Revenue and Losses

Invivyd is a biopharmaceutical company focused on developing treatments for COVID-19. As of March 31, 2024, Invivyd has not generated any revenue. The company has financed operations primarily through issuing stock and incurred significant losses:

• Net loss was $43.5 million in Q1 2024 compared to $35.3 million in Q1 2023
• Accumulated deficit since inception is $775.6 million as of March 31, 2024

Invivyd received emergency use authorization (EUA) from the FDA in March 2024 for its COVID-19 antibody treatment PEMGARDTM. The company expects to begin recognizing revenue from PEMGARD sales in Q2 2024. However, Invivyd expects to continue incurring losses as it advances its pipeline and builds commercial infrastructure.

Expenses

Operating expenses are categorized into:

• Research and development (R&D): Developing product candidates
• Acquired in-process R&D: Payments related to licensing deals
• Selling, general and administrative (SG&A): Overhead to run the business

Total operating expenses increased from $39.1 million in Q1 2023 to $46.1 million in Q1 2024. The increase was driven by R&D expenses rising $4.0 million and SG&A expenses rising $3.9 million.

Research and Development

R&D expenses increased due to:

• Higher costs for commercial manufacturing and clinical trials for lead product VYD222
• Nomination of second product candidate VYD2311 incurring initial costs

Selling, General and Administrative

SG&A expenses increased due to:

• More personnel to support company growth
• Higher commercialization costs with the PEMGARD approval

Cash and Funding

• Cash balance was $189.4 million as of March 31, 2024
• Cash used in operations was $50.2 million in Q1 2024
• Management estimates cash balance can fund operations for about 1 year
• Additional funding needed to continue operations long-term

Revenue Outlook

Invivyd projects it will begin generating product revenue from PEMGARD sales in Q2 2024. The company aims to continue advancing its pipeline of COVID-19 treatments leveraging its antibody development platform. If Invivyd gains approvals for other product candidates, it could generate additional revenue.

However, developing biopharmaceutical products entails risks and uncertainties. Many factors can impact clinical success, regulatory approval, and commercial adoption of new therapies.

Strengths and Weaknesses

Key Strengths

• Proprietary antibody development platform with proof of success having gained PEMGARD EUA
• Strong cash balance of $189 million provides funding for near-term goals
• Pipeline focused on shifting COVID-19 treatments to match evolving viruses

Key Weaknesses

• No approved products beyond PEMGARD, so limited commercial infrastructure
• History of losses and negative cash flow
• Relies completely on unstable equity and debt funding markets to finance operations long-term

Future Outlook

Invivyd aims to leverage its versatile antibody development platform to continuously introduce new COVID-19 therapies matched to emerging viral variants. The company also plans to expand to other infectious diseases like influenza in the future.

However, Invivyd only has one authorized product at this time in PEMGARD. The company may face challenges gaining approvals and commercial adoption for pipeline products. Additional funding will be needed to sustain research programs and operations long-term.