Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Dynavax Technologies Corp (DVAX, Financial) reported record net product sales of $79 million for Hep B in the third quarter.
- The company achieved a 44% market share in the US for Hep B, up from 41% in the same period last year.
- Dynavax Technologies Corp (DVAX) has authorized a $200 million share repurchase plan, indicating strong financial health.
- The company expects to achieve full-year profitability and positive net income for 2024.
- Dynavax Technologies Corp (DVAX) is actively enrolling in a Phase 12 trial for its shingles vaccine program, with top-line data expected in the second half of 2025.
Negative Points
- The Phase 1 extension study for the TAP program did not meet the threshold for advancement, leading to its discontinuation.
- The company anticipates a typical year-end market contraction of approximately 15% due to fewer patient visits during the holiday season.
- Dynavax Technologies Corp (DVAX) received a complete response letter from the FDA for the SBLA that adds a four-dose regimen for patients on hemodialysis.
- There is uncertainty regarding the timeline for FDA feedback on the proposed observational retrospective cohort study.
- The company faces challenges in developing a single-dose shingles vaccine candidate that meets non-inferiority margins compared to Shingrix.
Q & A Highlights
Q: With the updated 2030 market view, does the previous 2027 view of an $800 million total market still hold, or is it more linear growth to 2030?
A: Ryan Spencer, CEO: We see this as an extension of our guidance to 2030, not a change to our 2027 expectations.
Q: Is the majority of growth between 2027 and 2030 coming from the retail channel, and what drives confidence in retail growth?
A: Donn Casale, Chief Commercial Officer: Retail pharmacy is expected to drive growth due to infrastructure built post-pandemic and incentives for recommending adult vaccines. We see a shift from traditional hospital segments to retail.
Q: How do you expect gross margin to evolve over the next quarters, given the full-year guidance?
A: Kelly MacDonald, CFO: While we expect continued progress in gross margin, there may be quarterly fluctuations due to accounting and timing of recognizing costs, particularly in our Germany facility.
Q: Does the $200 million share repurchase plan indicate a priority over external business development?
A: Ryan Spencer, CEO: The share repurchase is part of a balanced capital allocation strategy. We remain focused on growth through external opportunities and believe there are still good opportunities available.
Q: Could the lower RSV vaccination rates impact Helia positively due to more capacity in the retail segment?
A: Donn Casale, Chief Commercial Officer: While there's opportunity for a plus-one campaign for Hep B, we have factored this into our guidance for Q4 and early 2025.
Q: Are there any learnings from the T A vaccine program that could apply to other vaccine programs?
A: Ryan Spencer, CEO: There's no negative read-through from one program to another. Each program is different, and we focus on building competitive products with high confidence in success.
Q: How do you view the possibility of a single-dose shingles vaccine candidate being non-inferior to Shingrix?
A: Robert Janssen, Chief Medical Officer: A single dose is challenging due to reactogenicity. We will evaluate one dose, but success is uncertain. Higher reactogenicity than Shingrix is unlikely to be successful.
Q: Can you provide details on the plague vaccine program and expected feedback from the Department of Defense?
A: Ryan Spencer, CEO: We are awaiting feedback from the Department of Defense on the contract and expect to hear back possibly this year or early next year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
