Goldman Sachs Turns Bearish On Vaccine Maker Dynavax Amid Shingles And Hepatitis B Uncertainty

Core Viewpoint - Goldman Sachs downgraded Dynavax Technologies Corporation from Neutral to Sell, reducing the price target from $15 to $12 due to increased competition in the shingles vaccine market, which may diminish the potential value of the Z-1018 program and create uncertainty regarding long-term revenue [1] Group 1: Competitive Landscape - GSK's Shingrix, featuring pre-filled syringes, is under review by the FDA and EMA, with a U.S. decision expected by June 20 [2] - Dynavax is conducting a Phase 1/2 trial to assess the safety, tolerability, and immunogenicity of Z-1018 against GSK's Shingrix in 441 healthy adults aged 50 to 69 [2] Group 2: Financial Performance - Dynavax reported preliminary HEPLISAV-B net product revenue of $268 million for 2024, reflecting a 26% year-over-year increase [3] - HEPLISAV-B net product revenue for Q4 2024 reached $71 million, up 39% [3] - Analysts estimate Q4 adjusted EPS of $0.04 and sales of $72.92 million, with 2024 sales forecasted at $278.13 million and adjusted EPS of $0.12 [4] Group 3: Regulatory Challenges - The FDA issued a Complete Response Letter in May 2024, indicating that the application for a four-dose regimen of HEPLISAV-B lacked sufficient data for a full evaluation of effectiveness or safety [4]