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IVVD

Invivyd, Inc.

Invivyd, Inc. Q2 FY2024 earnings call

August 14, 2024 · fiscal period ended 2024-06

EPS · actual vs est

$-0.40 / $-0.37Miss -8.1%

Revenue · actual vs est

$2.3M / $5.0MMiss -54.7%
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Summary

Generated 2024-08-14

Management highlights

• Leadership transition at Invivyd aimed to expand corporate ambition and improve delivery of medical value for vulnerable populations, with immediate initiatives to enhance operational posture and efficiency. • Rapidly expanding commercial footprint and pipeline advancement were noted, though early net revenue results were not satisfactory but showed consistent growth in Q2 with acceleration in early 3Q. • Tim Lee joined as Chief Commercial Officer, onboarded experienced team, worked on commercialization of PEMGARDA, including refining commercial launch metrics, preparing an activation campaign, and engaging with healthcare providers. • VYD2311 pipeline advancement with Australian ethics approval for first-in-human study, planning to interrogate multiple routes of administration. • Discussion on virology, surrogate markers for COVID-19 antibodies, and evolving approach to address virus evolution, leveraging structural biology and discovery platform. • Streamlining operations and burn rate related to production of VYD2311, with plans to transition to it after exhausting PEMGARDA supply.

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Segment performance

No specific financial performance details for product segments in absolute terms and revenue contribution percentages were provided in the transcript.

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Guidance

• Reaffirmed revenue and cash guidance provided previously, with plans to refine guidance in the fall. • Focus on the upcoming commercial push in the fall/winter respiratory virus season, anticipating significant activity as the season approaches.

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Risks

• Virus evolution can quickly obsoleter single SVNA titer point estimates and affect antibody potency. • Variability in assay systems limits the accuracy of analyses related to antibody potency and regulatory actions. • Challenges in maintaining consistent efficacy across different virus variants, though Invivyd aims to leverage conserved epitopes to mitigate this.

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Q&A highlights

Q: Tim, perspective on optimizing success, summer wave, and fall immunization season A: Tim Lee discussed bringing on a seasoned team, starting digital work, increasing corporate campaign work, updating PEMGARDA infusion locator, noting over 200 sites, engaging with the patient community, and focusing on the immunocompromised population's needs Q: EUA status, magnitude of opportunity, availability of infusion sites A: Marc Elia stated EUA submission is done and in discussion with FDA, magnitude of treatment opportunity not quantifiable yet; Tim Lee mentioned infusion locator is being updated in real time, with efforts to reach major academic medical centers and private infusion sites Q: OUS status, visibility on ordering A: Marc Elia talked about OUS exploration under constant discussion, with focus on VYD2311 due to PEMGARDA supply constraints; visibility on ordering noted an acceleration in Q3 with major activity expected in fall/winter respiratory virus season

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-0.40$-0.37-8.1%
Revenue$2.3M$5.0M-54.7%

Transcript

August 14, 2024

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Prior quarters

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