Release Date: May 08, 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 a 10% year-over-year growth in HEPLISAV-B net product revenue for Q1 2024.
- The company reaffirmed its full-year 2024 net product revenue guidance for HEPLISAV-B to be in the range of $265 million to $280 million.
- Dynavax Technologies Corp (DVAX) is seeing positive market share growth, achieving an estimated 41% market share in Q1 2024, up from 37% in the same period last year.
- The company is advancing its innovative vaccine pipeline, including the initiation of a Phase 1/2 trial for its shingles vaccine candidate and long-term follow-up data for its Phase 1 Tdap trial.
- Dynavax Technologies Corp (DVAX) maintains a strong financial position with $724 million in cash, cash equivalents, and marketable securities, sufficient to support its current pipeline assets and organic business growth.
Negative Points
- The US hepatitis B vaccine market experienced a slight decrease during Q1 2024 due to an extended cough, cold, and flu season, which reduced vaccination opportunities.
- Despite growth, the company reported a net loss of $9 million in Q1 2024, although this was an improvement from a $24 million loss in the prior year period.
- There was a noted decrease in HEPLISAV-B's market share in the retail segment from 58% in Q4 to 55% in Q1, attributed to purchasing patterns of large customers.
- Selling, general, and administrative expenses increased to $44 million in Q1 2024 from $37 million in the prior year period, driven by increased headcount and strategic growth investments.
- The company faces ongoing challenges with the seasonality of vaccine sales, particularly due to significant respiratory vaccine activity in Q4 and Q1 each year.
Q & A Highlights
Q: The retail market share for HEPLISAV-B dipped slightly from Q4 to Q1, from 58% to 55%. Was there a change in contracts or other factors that caused this?
A: Donn Casale, Chief Commercial Officer, explained that the slight variation in market share is typical and related to the purchasing patterns of large customers. The expectation is to continue gaining market share in both retail and IDM, attributing the fluctuation to normal purchasing patterns.
Q: Can you provide details on the trial design for the shingles vaccine, particularly in terms of patient selection and endpoints?
A: Rob Janssen, Chief Medical Officer, noted that the trial is designed to identify optimal levels of the GE antigen and to evaluate different vaccination schedules to enhance CD4 counts. The study aims to develop a shingles vaccine with improved tolerability and comparable efficacy, focusing on CD4 responses as a critical measure of immunogenicity.
Q: With the financial position Dynavax is in, is there a hesitation to make significant decisions regarding the cash balance until the immunogenicity data from the shingles program is available?
A: CEO Ryan Spencer stated that the upcoming data is one of several factors considered in managing their capital structure. The company aims to maintain flexibility to advance their pipeline while managing financial resources effectively.
Q: How does Dynavax view the seasonality in the hepatitis B vaccine market, and what are the expectations for market growth throughout the year?
A: Ryan Spencer mentioned that Q2 and Q3 are typically the largest quarters for the adult hepatitis B vaccine market, a trend expected to continue due to various factors, including market and disease dynamics.
Q: What impact do you foresee from the PDUFA date on May 13 for HEPLISAV-B in hemodialysis patients?
A: Ryan Spencer highlighted that while the approval would provide a commercial opportunity, it's too early to comment on specific revenue expectations. The focus will be on engaging customers effectively once the regulatory approval is granted.
Q: Can you elaborate on the activities and focus of retail chains regarding hepatitis B vaccinations?
A: Donn Casale noted a significant shift in focus towards non-respiratory vaccines like hepatitis B, with retail chains implementing various initiatives to increase vaccination awareness and uptake, particularly leveraging the momentum from hepatitis B Awareness Month.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
