Dynavax record hep B sales

 

• Net Product Sales: $79 million for Hep B in Q3 2024.

• Market Share: Hep B achieved 44% total U.S. market share in Q3 2024, up from 41% in Q3 2023.

• Gross Margin: Improved to 84% in Q3 2024 and 82% for the first nine months of 2024.

• Net Income: $18 million for Q3 2024.

• Cash and Equivalents: Approximately $764 million at the end of Q3 2024.

• Full Year Revenue Guidance: Narrowed to $265 to $270 million for Hep B net product revenue in 2024.

• R&D Expenses: $14 million for Q3 2024.

• SG&A Expenses: $43 million for Q3 2024, up from $38 million in Q3 2023.

• Share Repurchase Plan: $200 million authorized by the board.

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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 (NASDAQ:DVAX) 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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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.

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