Dynavax's Q3 2025: Contradictions Emerge on Market Share Aspirations, Retail Vaccination Shift Impact, Oral Vaccine Trial Design, and Shingles Vaccine Differentiation

Business Commentary:

* Heplisav-B Market Performance:
- Dynavax reported $90 million in net product revenue from Heplisav-B this quarter, representing a 13% increase year-over-year.
- Market share in the U.S. adult hepatitis B vaccine market reached 46%, up from 44% the previous year.
- The growth was driven by Heplisav-B's differentiated clinical profile and proven commercial execution under the ACIP universal recommendation.

• Pipeline Progress:
• The company made progress in its shingles vaccine program, initiating Part 2 of the phase 1-2 study in adults aged 70 and older.
• Top-line immunogenicity and safety results are expected in the second half of 2026.

• This progress is supported by the potential of strategic partnerships to realize the global value of the vaccine candidate.
  

• COVID-19 Vaccine Deal:

• Dynavax entered into a strategic license agreement for Vaxart's novel oral COVID-19 vaccine, with the program currently in a phase 2b safety and efficacy study.
• The deal was structured with clear de-risking steps before significant future spend on phase 3 development.

• The agreement aims to add a novel vaccine program with high potential upside to the pipeline, leveraging Dynavax's experience in late-stage development and commercialization.

• Capital Allocation and Share Repurchase:

• The company authorized a new $100 million share repurchase plan, reflecting confidence in Dynavax's long-term growth and commitment to enhancing shareholder value.
• This is in addition to a previously completed $200 million share repurchase program.
• The capital allocation strategy includes returning capital to shareholders while investing in growth opportunities through strategic business development transactions.

Contradiction Point 1

Market Share Aspirations and Retail Strategy

It involves the company's long-term market share goals and the strategy to achieve them, which directly impacts investor expectations and business planning.

How confident are you in achieving the 60% share by 2030, and what factors will bridge the gap between your current position and long-term goals? - Paul Choi(Goldman Sachs)

2025Q3: We expect to continue to make progress toward the 60% market share goal by 2030. Growth will come from increased share in the retail segment, which is also where Dynavax already has its highest share. - Ryan Spencer(CEO), Don Casale(CMO)

How do you assess the share repurchase program's performance, and are there plans to restart it? - Jonathan Miller(Evercore)

2025Q2: We expect to reach 52% share by the end of 2022 and 60% market share by 2030. This is a stated goal that we will continue to make progress on. - Ryan Spencer(CEO), Don Casale(CMO)

Contradiction Point 2

Retail Vaccination Shift Impact on Long-Term Guidance

It involves the impact of a shift in vaccination practices, specifically the move to retail settings, on the company's long-term guidance, which is crucial for investor expectations and planning.

How confident are you in achieving the 60% share by 2030, and what key factors will bridge the gap between your current position and that goal? - Paul Choi(Goldman Sachs)

2025Q3: We feel like we are on pace to achieve this. We expect to continue to make progress toward the 60% market share goal by 2030. Growth will come from increased share in the retail segment, which is also where Dynavax already has its highest share. - Ryan Spencer(CEO), Don Casale(CMO)

What's driving the shift to retail for hepatitis B vaccines, and how does it impact long-term guidance? - Jonathan Miller(Evercore)

2025Q2: We are clearly optimistic about the opportunity in retail, but no changes to our long-term guidance. - Ryan Spencer(CEO)

Contradiction Point 3

Oral COVID Vaccine Development and Clinical Trial Design

It highlights inconsistencies in the description of the oral COVID vaccine trial design and what would constitute a positive outcome, which is crucial for understanding the company's strategy and investments in development.

What is needed to advance the oral vaccine program and what is the estimated development cost? - Phil Nadeau (TD Cowen)

2025Q3: The trial is powered to demonstrate an improvement over the mRNA vaccine comparator. Dynavax will look for an improved product with reduced symptomatic infections and hospitalizations, leveraging the unique delivery and mechanism of action. - Ryan Spencer(CEO)

How does capital allocation and business development align with the long-term strategy, given the discontinuation of TDAP and the announcement of new preclinical programs? - Matthew Phipps (William Blair)

2025Q1: The trial is designed to show an improvement head-to-head against an mRNA vaccine pill. Dynavax will have to look at the full data package. - Ryan Spencer(CEO)

Contradiction Point 4

Shingles Vaccine Market Differentiation

It highlights the company's expectations for its shingles vaccine and its competitive positioning, which are crucial for stakeholders to understand the potential impact on the market and the company's products.

Why license a COVID vaccine now? What trial progress with 5,400 patients? What criteria for confident opt-in? Is trial aiming for superiority or similar efficacy with better tolerability? - Matthew Phipps (William Blair)

2025Q3: The deal is strategic and fits Dynavax's capabilities. The market has room for growth with improved options. The trial is powered to demonstrate an improvement over the mRNA vaccine comparator. - Ryan Spencer(CEO)

What safety differentiation and market share gains would be commercially relevant for the shingles vaccine? - Jonathan Miller (Evercore ISI)

2024Q4: The safety profile is critical, and we believe the differences observed in our Phase I study are significant. We'll use market research to assess product profiles and commercial prowess. - Ryan Spencer(CEO)