Dynavax Q2 2024 Financial Results and Business Updates

Dynavax Technologies Corporation, a commercial-stage biopharmaceutical firm specializing in innovative vaccines, has announced robust financial results and significant business developments for the quarter ending June 30, 2024. The company achieved record quarterly revenue for its HEPLISAV-B® hepatitis B vaccine, tallying $70.2 million, up 24% from the same period in the previous year. This positions Dynavax favorably to meet its full-year revenue guidance of $265 - $280 million for 2024.

Ryan Spencer, Dynavax's CEO, expressed confidence in the company's long-term prospects in the U.S. adult hepatitis B vaccine market, which comprises over 130 million eligible patients. Spencer projects the market for HEPLISAV-B to exceed $800 million by 2027, with continued growth throughout the decade. This optimistic forecast is bolstered by HEPLISAV-B’s uptake, which requires only two doses over one month, unlike other vaccines. The company reported a market share increase to approximately 42% in the U.S., with notable growth in the retail pharmacy segment (59%) and among Integrated Delivery Networks (IDNs) and large clinics (56%).

In addition to HEPLISAV-B, Dynavax is advancing its clinical pipeline. The company recently commenced dosing in a Phase 1/2 trial of its new shingles vaccine, Z-1018. This trial will compare the safety and immunogenicity of Z-1018 against Shingrix® in 440 adults aged 50-69, with results anticipated in the latter half of 2025. Additionally, Dynavax is continuing its Tdap-1018 booster immunization program for tetanus, diphtheria, and pertussis, and expects long-term follow-up data by the end of 2024.

Another promising project is Dynavax’s plague vaccine, developed in collaboration with the U.S. Department of Defense. Currently in a Phase 2 clinical trial, the company expects to provide updates based on trial results and nonhuman primate studies by the last quarter of 2024.

Financially, Dynavax shows strong performance. The company reported total revenues of $73.8 million for Q2 2024, a 22% increase year-over-year. This includes HEPLISAV-B’s net revenue of $70.2 million. Overall, the firm’s financial health remains solid with cash, cash equivalents, and marketable securities totaling $735.6 million as of June 30, 2024.

Cost of sales for HEPLISAV-B dropped to $12.0 million, primarily due to improved manufacturing processes. Research and development expenses rose to $15.0 million, attributed to investments in the company’s clinical pipeline. Selling, general, and administrative expenses also increased to $41.7 million, reflecting higher headcount and strategic investments.

Looking forward, Dynavax maintains its full-year 2024 financial guidance with expected HEPLISAV-B net product revenue of $265 - $280 million, a gross margin of around 80%, and research and development expenses between $60 - $75 million. Selling, general, and administrative expenses are projected to be between $160 - $180 million. The company anticipates higher cash and marketable securities by year-end 2024 compared to December 31, 2023.

Dynavax will host a conference call to discuss these updates, reinforcing its position as a leader in innovative vaccines aimed at addressing significant public health needs. The company continues to target growth through strategic opportunities and portfolio diversification, aiming to deliver sustained value to its shareholders.