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VRDN

Viridian Therapeutics, Inc.\DE

Viridian Therapeutics, Inc.\DE Q4 FY2020 earnings call

March 25, 2021 · fiscal period ended 2020-12

EPS · actual vs est

$-5.31 / $-1.27Miss -318.1%

Revenue · actual vs est

$54,000 /
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Summary

Generated 2021-03-25

Management highlights

  • Merger in October 2020 of private Viridian with public miRagen Therapeutics, creating a new company. - Integrated operations in Boulder, CO and Waltham, MA. - Appointed Vahe Bedian as Chief Scientist and Barrett Katz as Chief Medical Officer. - Rebranded to Viridian Therapeutics, focusing on clinically validated targets. - Lead program VRDN-001 for thyroid eye disease, with progress in manufacturing and preclinical work. - VRDN-002 is a next-gen IGF-1R antibody aiming for subcutaneous administration, on track for IND filing by year-end. - Discovery pipeline includes VRDN-003, VRDN-004, and plans for VRDN-005 later in 2021. - Barrett Katz assembled an ophthalmology team with experience in orphan eye diseases.
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Segment performance

Revenue for the fourth quarter of 2020 was $0.1 million, and for the full year, it was $1.1 million. Research and development expenses were $15.3 million in the fourth quarter and $28.3 million for the full year. General and administrative expenses were $5.5 million in the fourth quarter and $13.3 million for the full year. Acquired in-process research and development expenses totaled $69.9 million in 2020. Cash on hand ended the year at $127.6 million, which is expected to fund operations into the second half of 2023.

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Guidance

  • Cash runway of $127.6 million provides funding into the second half of 2023. - Expect to file IND for VRDN-001 in Q4 2021 and VRDN-002 by year-end. - Anticipate data from VRDN-001 in Q2 2022 and VRDN-002 mid-2022. - Plan to advance discovery pipeline and select target/indication for VRDN-005 later in 2021.
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Risks

  • Regulatory risks in obtaining IND approvals and FDA interactions. - Competition risks related to intellectual property and freedom to operate in thyroid eye disease space. - Uncertainties in clinical development timelines and efficacy outcomes.
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Q&A highlights

Q: Chris Howerton from Jefferies asked about interactions with regulators, freedom to operate, and gating steps for VRDN-004.

A: Jonathan Violin responded that they are confident in freedom to operate, will share regulatory plans after dialogue, and VRDN-004 will be shared when competitive balance favors.

Q: Jason Butler from JMP Securities asked about clinical trial site selection, learnings from TEPEZZA, and gating steps for VRDN-004.

A: Barrett Katz discussed clinical trial site selection in the TED community, focus on proof-of-concept for VRDN-001, and VRDN-004 will be shared when balance favors.

Q: Leland Gershell from Oppenheimer asked about subcutaneous formulation progress for 001, dosing intervals for 002.

A: Jonathan Violin talked about subcutaneous formulation progress and need for clinical data to determine dosing intervals for 002.

Q: Michael Higgins from Ladenburg Thalmann asked about progress with Zenas BioPharma.

A: Jonathan Violin mentioned collaborative relationship with Zenas but no specific timing on activity.

Q: Vernon Bernardino from H.C. Wainwright asked about efficiencies in development pathway for VRDN-001/002.

A: Barrett Katz discussed leveraging strong efficacy of receptor blockade for efficient development.

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-5.31$-1.27-318.1%
Revenue$54,000

Transcript

March 25, 2021

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