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Dynavax Technologies (DVAX 1.83%) held its Q4 2024 earnings call on February 20, 2025, at 4:30 p.m. ET. The discussion included prepared remarks and a Q&A session, where key executives participated. The call was recorded and opened with instructions on how to engage in the Q&A. Paul Cox, Vice President of Investor Relations and Corporate Communications, initiated the call. He was joined by Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer; and Kelly MacDonald, Chief Financial Officer.
Dynavax Technologies released its financial results for the fourth quarter and full year ending December 31, 2024. The report, along with a supplementary slide presentation, is available on the company’s website. Cox noted that forward-looking statements would be made during the call, highlighting expectations regarding market sizes, marketing strategies, financial guidance, and other operational aspects. He emphasized the presence of risks and uncertainties that could lead to differing results, as detailed in the press release and SEC filings.
Ryan Spencer expressed satisfaction with 2024’s achievements, including record HEPLISAV-B product revenue, advancements in pipeline programs, profitability, and share repurchase plans. He outlined expectations for 2025, aiming for substantial HEPLISAV-B sales growth, developments in the clinical pipeline, and new programs. The shingles program, identified as the most advanced clinical initiative, presents significant market opportunities. He expressed confidence in achieving a competitive vaccine profile through planned developments for the Z-1018 program.
Donn Casale highlighted HEPLISAV-B’s leadership in the U.S. hepatitis B adult vaccine market, achieved through a differentiated profile and strong commercial execution. The ACIP Universal recommendation has expanded the addressable market, sustaining HEPLISAV-B’s performance. Market dynamics, such as Medicare and HEDIS changes, are expected to support future growth and market share expansion for HEPLISAV-B.
Rob Janssen provided an overview of the clinical pipeline. The Z-1018 shingles vaccine program has demonstrated favorable initial results compared to Shingrix. The ongoing phase 1/2 trial targets further evaluation, with outcomes expected in Q3 2025. Janssen also mentioned the Plague Vaccine program, supported by the U.S. Department of Defense, with plans to initiate a phase 2 clinical trial by Q3 2025. Additionally, work continues on enhancing the HEPLISAV-B regimen for adults on hemodialysis, with expectations for resubmitting data to the FDA.
Kelly MacDonald discussed the financial results for Q4 and the full year 2024. HEPLISAV-B net sales reached milestones with significant year-over-year increases, contributing to a strengthened financial outlook. Gross margin improvements and controlled SG&A expenses were noted. MacDonald introduced a non-GAAP measure of adjusted EBITDA, highlighting robust growth. Dynavax concluded 2024 with a healthy cash position, partially allocated toward share buybacks, with plans to continue this strategy.
The call transitioned to a Q&A session where analysts inquired about market share growth, shingles program specifics, and financial strategies. The Dynavax team provided insights into the commercial execution, market trends, and anticipated developments in the clinical pipeline.
In conclusion, Dynavax Technologies reported strong performance in 2024 and plans to build on this momentum in 2025. The company aims to maintain its leadership in the hepatitis B vaccine market while advancing its pipeline and exploring opportunities to enhance shareholder value.
