Dynavax Technologies Corporation Q1 FY2025 earnings call

• HEPLISAV-B had a strong first quarter with $65 million in net revenue, a 36% year-over-year increase, and is on track for the top half of the full year guidance range of $305M to $325M for net product sales.
• Pipeline advancement: The shingles program is most advanced; Phase I/II part one top line readout expected in Q3. The pandemic influenza adjuvant program to initiate Phase I/II trial in Q2. The Lyme disease program to enter IND-enabling studies in 2027. Plague vaccine program plans to initiate Phase II trial in Q3 2025.
• Commercial: HEPLISAV-B's U.S. market share rose to 43% in Q1, up from 41% last year. Retail segment grew ~70% y/y in Q1. Long-term outlook for HEPLISAV-B market opportunity peaking over $900M by 2030 with at least 60% market share.
• Capital allocation: Over 85% of $200M share repurchase program executed, focusing on core assets and potential business development opportunities.

HEPLISAV-B was the key segment. In the first quarter of 2025, HEPLISAV-B achieved net revenue of $65 million, which is a 36% increase compared to the same period last year. For the full year, the guidance for HEPLISAV-B net product sales is between $305 million to $325 million, and the company is on track to achieve the top half of this range. HEPLISAV-B contributes significantly to the company's revenue, with its strong performance in the first quarter setting a positive trajectory for the year.

• HEPLISAV-B net product revenue guidance remains $305M to $325M, and the company now expects to achieve the top half of this range due to the strong first quarter performance.
• Adjusted EBITDA is expected to be at least $75M, demonstrating the ability to grow adjusted EBITDA at more than two times the rate of product revenue.

• Forward-looking statements involve risks and uncertainties, including potential differences between actual results and expectations, risks related to FDA submissions, clinical trial starts and data readouts, and market dynamics. These risks are detailed in the company's SEC filings, including the quarterly report on Form 10-Q.

Q: Why not officially raise the lower end of guidance then if confidence in that hitting that upper half?

A: Ryan Spencer says at this point, it's prudent to maintain the overall guidance range as only one quarter into the year, highlighting good progress to start the year off as the intention with the commentary around the upper half of the range.

Q: What are you seeing along the lines of seasonality in HEPLISAV-B performance? Do you expect what we saw this year to be the new normal or was there anything special about this past winter?

A: Donn Casale says what was seen, particularly in retail, was a fast start with focus on non-flu vaccines like hepatitis B vaccine this year versus past years, with the retail segment seeing 70% growth year-over-year, contributing to less seasonality than past years.

Q: Do you think the FDA's consideration of requiring placebo-controlled trials for all new vaccines will be relevant to your programs?

A: Ryan Spencer says for the shingles program, there's supportive feedback on placebo-controlled studies, and for other programs, it's too soon to tell, but at this point, it doesn't see it as a major challenge to ongoing or future development.

Q: If you do not see the 75% threshold, median CD4T cell level versus Shingrix in the one-month data next quarter, are you going to stop the shingles program?

A: Rob Janssen explains that while one-month data is informative, the 12-month measurement of CD4 frequency is more informative as CD4s expand quickly but drop fast, and a 12-month measurement stabilizes and is more informative for decision-making.