Invivyd, Inc. Q3 FY2023 earnings call

• Dave Hering highlighted recent business highlights, including completion of enrollment in the CANOPY Phase 3 trial with ~750 participants (≈300 immunocompromised), anticipation of initial primary endpoint data in late 2023/early 2024, and the unmet medical need for COVID-19 mAbs in immunocompromised individuals. • Pete Schmidt discussed in vitro pseudovirus testing showing VYD222 retains neutralization activity against recent SARS-CoV-2 variants, details of the CANOPY trial cohorts (Cohort A: immunocompromised, Cohort B: at-risk for exposure), and engagement with the FDA on immunobridging for EUA. • Jeremy Gowler outlined the market opportunity with over 9 million immunocompromised people at risk for severe COVID-19 in the US, ongoing go-to-market planning, market research with HCP, payer and pricing work, and manufacturing of VYD222 commercial inventory with WuXi. • Bill Duke reported Invivyd ended Q3 2023 with ~$265M in cash, cash equivalents, and marketable securities, expecting to fund operating expenses into Q4 2024.

No specific product segment financial performance data on absolute revenue and contribution % provided in the transcript.

• Bill Duke stated that with current operating plans, cash (excluding potential VYD222 revenue) will fund operating expenses into Q4 2024. • Goal to apply for EUA in the US as soon as practicable assuming supportive data for clinical, nonclinical, and CMC data packages.

• Uncertainty around SARS-CoV-2 variant evolution and their impact on VYD222's efficacy. • Regulatory approval timelines and potential challenges in securing EUA. • Market adoption challenges for commercial launch, including payer coverage and reimbursement.

Q: Congrats on enrollment completion in CANOPY Phase 3 trial. What to see in Day 28 serum neutralizing titers for EUA submission? Can submit following primary endpoint data from Cohort A?

A: Pete Schmidt noted primary endpoint at Day 28 is immunobridging endpoint/serum neutralizing titers vs historical adintrevimab trial data. Dave Hering said EUA submission package is combination of clinical, nonclinical, and CMC, with pivotal CANOPY data being one element.

Q: On commercial launch preparations, reimbursement codes, launch trajectory, and focus?

A: Jeremy Gowler said premature to give specifics on coding, but working on market access plan. Dave Hering mentioned focus on upper right quadrant of ~485,000 highest risk and highest uptake immunocompromised patients like stem cell transplant recipients, solid organ transplant recipients, and blood cancer patients.

Q: What are gating factors for submission? How confident FDA will approve based on titers?

A: Dave Hering said gating components are collecting preliminary primary endpoint data by end of 2023/early 2024 and combining with other data elements. Confident in using titer values as surrogate endpoint aligned with FDA via immunobridging.

Q: How often update in vitro neutralization assay for circulating variants? EUA for pre/post exposure?

A: Pete Schmidt said update in real-time as soon as data is available, no set schedule. Pursuing PrEP indication only, not post-exposure prophylaxis.

Q: Sense of sales force size for targeted population approach, pre-commercial manufacturing ramp, Phase 1 data implications, and payer acceptance of surrogate?

A: Jeremy Gowler said sales force size still in sizing exercise, but focused on concentrated market. Dave Hering mentioned begun preparing commercial material, balancing cost and availability. Pete Schmidt said no recent Phase 1 updates, will consider totality of data. Jeremy Gowler said acceptability of surrogate exists as it's not new in infectious disease with vaccines using surrogate endpoints.