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Viridian Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Net product revenue for Lumvoa was $24.7 million for the three months ended September 30, 2026, compared to $0 in the same period in 2025.
    • Total revenues were $25.8 million for the three months ended September 30, 2026, compared to $70.6 million in the same period in 2025, driven by a decrease in license revenue from $70.0 million to $0.1 million.
    • Research and development expenses were $70.1 million for the three months ended September 30, 2026, a decrease from $86.3 million in the prior year period, driven by reduced clinical study expenses for veligrotug and elegrobart, partially offset by increased investment in the TSHR program and FcRn portfolio.
    • Selling, general, and administrative (SG&A) expenses were $57.6 million for the three months ended September 30, 2026, an increase from $24.3 million in the prior year period, driven by increased personnel-related costs and professional services to support commercial activities.
    • Net loss was $101.2 million for the three months ended September 30, 2026, compared to $34.6 million in the same period in 2025.
    • Cash, cash equivalents, and marketable securities totaled $955.2 million as of September 30, 2026, compared to $874.7 million as of December 31, 2025.
    • Total liabilities increased to $448.0 million as of September 30, 2026, from $177.3 million as of December 31, 2025.
    • Net loss per share, basic and diluted, was $0.81 for the three months ended September 30, 2026, compared to $0.34 in the prior year period.
  • Guidance and Future Outlook:

    • The company expects to submit a Biologics License Application (BLA) for elegrobart in the first quarter of 2027.
    • Viridian anticipates initiating a Phase 1 clinical trial for VRDN-292 in patients in the fourth quarter of 2026.
    • The company expects to disclose VRDN-008 Phase 1 healthy volunteer data and development plans for the FcRn portfolio in the fourth quarter of 2026.
    • Existing cash and anticipated future commercial revenues from Lumvoa and elegrobart (if approved) are expected to fund the company's current business plans through profitability.
    • The company anticipates launching elegrobart, if approved, in a commercially available autoinjector with at-home, subcutaneous Q4W and Q8W dosing.
  • Business Segments and Product Lines:

    • Lumvoa (veligrotug-vvze): Generated $24.7 million in net product revenue with more than 100 patients on therapy as of September 30, 2026. Significant market access progress was made, including the assignment of a permanent J-code (J3242) by CMS effective January 1, 2027.
    • Elegrobart: A subcutaneously administered anti-IGF-1R therapy currently in late-stage development for Thyroid Eye Disease (TED). The commercial and medical infrastructure for Lumvoa is expected to support a potential elegrobart launch with limited incremental investment.
    • TSHR Program (VRDN-292): A potential best-in-class, half-life extended monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR), designed for subcutaneous delivery in an autoinjector with potential for extended dosing intervals.
    • FcRn Portfolio: VRDN-006, an Fc fragment inhibitor, showed IgG reductions consistent with the class, spared albumin and LDL, and was generally well-tolerated in Phase 1 healthy volunteer trials. VRDN-008, a bispecific half-life extended FcRn inhibitor, demonstrated a longer half-life and more sustained IgG reduction versus efgartigimod in non-human primate head-to-head studies.
  • Market and Competitive Landscape:

    • The company focuses on Thyroid Eye Disease (TED) and autoimmune diseases, positioning Lumvoa as a full IGF-1R antagonist approved by the U.S. FDA for TED.
    • The company highlights the potential for VRDN-292 to be a best-in-class therapy with patient convenience features like extended dosing intervals.
    • CMS has assigned Lumvoa a permanent J-code, facilitating reimbursement and market access.
  • Risks and Challenges:

    • The company has historically incurred losses and may not be able to secure additional capital when needed.
    • There is a limited history of generating revenue from product sales.
    • Risks include potential inability to maintain commercial manufacturing, sales, and marketing capabilities or enter into third-party commercialization agreements.
    • Market acceptance of veligrotug and other product candidates is uncertain.
    • Clinical trial results may not be representative of future results, and preliminary data may not reflect final data.
    • Regulatory delays or failures to obtain approvals could impact development timelines and commercialization.
    • Competition from other therapies or products exists in the autoimmune and rare disease sectors.
  • Management Commentary and Tone:

    • Steve Mahoney, President and CEO, stated the company is "highly encouraged" by the strength of Lumvoa's early launch in TED, noting it has exceeded expectations.
    • Management attributed the early results to Lumvoa's clinical profile, the execution of Commercial and Medical teams, and organizational support.
    • The tone is optimistic regarding the pipeline, citing excitement about building momentum on Lumvoa and advancing elegrobart toward a BLA submission.
    • Management expressed confidence in the company's ability to execute its launch strategy and bring Lumvoa to more patients.
  • Other Key Points:

    • As of September 30, 2026, the company had 125,636,093 shares of common stock outstanding on an as-converted basis.
    • The company hosted a webcast on November 4, 2026, at 8:00 a.m. ET to discuss results.
    • Viridian will participate in the Jefferies Global Healthcare Conference in London on November 16, 2026, and the UBS Global Biopharma London Conference on November 17, 2026.
    • Accounts receivable increased to $29.8 million as of September 30, 2026, from $0 as of December 31, 2025, reflecting the start of commercial sales.
Company
VIRIDIAN THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology