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PCVX

Vaxcyte, Inc.

Vaxcyte, Inc. Q4 FY2020 earnings call

March 29, 2021 · fiscal period ended 2020-12

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Summary

Generated 2021-03-29

Management highlights

• Progress across vaccine pipeline, with VAX-24 making key manufacturing milestones for IND submission, VAX-XP showing robust immunogenicity data, VAX-A1 nominating final candidate in Q1 2021 with IND enabling activities expected in second-half 2021, and VAX-PG expected to nominate final candidate in second-half 2021. • Completed Series D and IPO financings in 2020, resulting in strong balance sheet. • VAX-24's lead vaccine candidate progress, including its potential to replace existing pneumococcal vaccines and the scalability of the technology platform.

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Segment performance

No detailed financial performance by product segment with revenue contributions provided in the transcript.

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Guidance

• VAX-24 IND submission timing revised from second-half 2021 to between January and June 2022 due to manufacturing delays and COVID-19 impact. • Top line data from VAX-24 Phase 1/2 clinical study expected in late 2022 to early 2023. • VAX-A1 to initiate IND enabling activities in second-half 2021. • VAX-PG to nominate final candidate in second-half 2021. • Committed to delivering 24 conjugated drug substances for long-term success.

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Risks

• Delays in manufacturing process at Lonza due to process-related issues and COVID-19 impact on operations. • Uncertainties in vaccine development timelines and regulatory approvals. • Impact of COVID-19 pandemic on business operations and supply chains.

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Q&A highlights

Q: How many conjugated drug substances have Lonza successfully completed? What are key variables driving IND submission timing range?

A: Lonza completed first two stages of the drug substance (DS) campaign and is in the process of making the 24 conjugates. Key variables driving the IND submission timing range include completing all 24 conjugates passing analytical tests, the drug product campaign, and stability testing.

Q: Thoughts on ACIP guidelines update, impact of COVID on PCV importance, and OpEx for 2021?

A: COVID increases the importance of pneumococcal vaccines as it shows the need for broader protection. ACIP may update guidelines on vaccination ages and cost-effectiveness. OpEx is expected to increase substantially, with R&D and G&A expenses rising due to pipeline advancement and company growth.

Q: Prioritization of VAX-A1 and VAX-PG programs?

A: VAX-A1 is ahead in timeline with IND enabling activities expected in second-half 2021, while VAX-PG will nominate its final candidate in second-half 2021, and both programs will be advanced.

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Key numbers

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Transcript

March 29, 2021

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