DVAX

• Ryan Spencer highlighted driving top-line growth and market share expansion for HEPLISAV-B, advancing pipeline programs, executing a strategic deal with Vaxart for a Phase IIb COVID-19 oral vaccine candidate, and authorizing a $100 million share repurchase plan.
• Donn Casale discussed HEPLISAV-B's strong commercial performance, 46% market share, progress in retail and IDN segments, and expectations for retail to be the dominant channel for adult hepatitis B vaccination by 2030.
• Rob Janssen provided pipeline updates, including shingles vaccine entering Part 2 of Phase I/II study, plague vaccine program advancements, pandemic influenza adjuvant program progress, and HEPLISAV-B sBLA engagement with FDA.
• Kelly MacDonald reviewed financial results, noting $90 million net sales for HEPLISAV-B, $95 million total revenues, R&D and SG&A expenses, GAAP and non-GAAP financials, cash position, and $100 million share repurchase plan.

• Reiterated HEPLISAV-B net product revenue guidance of $315 million to $325 million for 2025.
• Expect adjusted EBITDA of at least $80 million for 2025, an improvement from prior guidance.
• Authorized a new $100 million share repurchase program.
• Vaxart deal structured with upfront $25 million and potential future payments based on Phase IIb data.

For the third quarter, HEPLISAV-B generated approximately $90 million in net product revenue, a 13% year-over-year increase. Its estimated U.S. adult hepatitis B vaccine market share reached 46%, up from 44% in the prior year period. On a trailing 12-month basis, HEPLISAV-B achieved 45% total market share, including 59% in retail and 51% in the IDN segment.

• Forward-looking statements involve uncertainties around market sizes, FDA submissions, clinical trial results, strategic arrangements, and share repurchase program.
• Risks related to potential failures in clinical trials, regulatory approvals, and market adoption of new products.

Q: Curious why license a COVID vaccine today? What powering does the trial have at 5,400 patients? What do you hope to achieve here?

A: Ryan Spencer said it's a strategic opportunity, study is adequately powered to show improvement over mRNA comparator, and hopes to see an improved option leveraging different MOA.

Q: By the end of next year, can you be in a position to do registrational studies for both shingles and oral COVID-19?

A: Ryan Spencer said they have the capacity and can manage staging of activities.

Q: What do you need to see to advance? Cost of development? Seasonality of HEPLISAV?

A: Ryan Spencer said trial is to show improvement vs mRNA, Kelly MacDonald discussed cost of registrational study, Donn Casale talked about seasonality with holidays affecting Q4.

Q: Vaxart's first-gen COVID vaccine had weak IgG responses. What have you seen to suggest strong serum immunity? Reason study was limited in size? Issues with government development?

A: Ryan Spencer said need efficacy study to know, Kelly MacDonald discussed cost, Ryan Spencer talked about study size reduction due to BARDA decision and BARDA supporting enrolled patients.

Q: HEPLISAV market outlook? Status of shingles Part 2 study?

A: Ryan Spencer and Donn Casale discussed confidence in achieving 60% market share by 2030, Rob Janssen updated shingles Part 2 study started enrolling and dosing.