Dynavax (DVAX) FY Conference June 03, 2025 03:40 PM ET Speaker0 Analyst here at William Blair. Thank you all for coming, part of our forty fifth Annual Growth Stock Conference. Happy to introduce Dynavax and Ryan Spencer, CEO. We're to talk a little bit about the continued growth of HEPLISAV. It's been becoming a great business for the company and also, I think, a little bit of expansion opportunities that they're evaluating. Please visit williamblair.com for any and all disclosures. And with that, I'll tur ...

Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase year over year [5][25] - Total revenues for the first quarter reached $68 million, up 34% year over year [25] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year [25] - GAAP net loss for the first quarter was $96 million, compared to a net loss of $9 million in the first quarter of the previous year [27][28] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [28] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a 70% year over year growth in total market dose volume [12][14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [15] - The company anticipates continued market share gains throughout 2025, aiming for at least 60% market share by 2030 [16][17] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market has expanded significantly due to ACIP's universal recommendation, leading to a 16% increase in total market dose volume year over year [12][14] - The company expects the HEPLISAV B market opportunity to peak at over $900 million by 2030 [16] Company Strategy and Development Direction - Dynavax is focused on advancing its development pipeline, leveraging its vaccine adjuvant technology, CpG 1018, with key clinical trial milestones for shingles and plague vaccine programs [5][6] - The company announced new programs in pandemic influenza and Lyme disease, aiming to develop differentiated vaccines with lower risk development pathways [8][9] - The capital allocation strategy includes executing a $200 million share repurchase program while evaluating external opportunities for long-term growth [10][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top half of the annual revenue guidance range for HEPLISAV B due to strong early performance [5][31] - The company anticipates a banner year in 2025, supported by strong market growth and ongoing adoption of HEPLISAV B [10][32] - Management highlighted the importance of maintaining a disciplined approach to capital allocation and the potential for long-term growth opportunities [10][31] Other Important Information - The company recorded an allowance for doubtful accounts of $11 million related to a legacy COVID-19 adjuvant commercial supply agreement [27] - The company ended the first quarter with cash, cash equivalents, and marketable securities of $661 million, down from $714 million at the end of 2024 [29] Q&A Session Summary Question: Why not officially raise the lower end of guidance if confidence in hitting the upper half? - Management stated it is prudent to maintain the overall guidance range as the year is only one quarter in, despite good progress [34] Question: How does capital allocation and business development fit into the long-term value creation? - Management emphasized a balanced strategy focusing on leveraging core assets, advancing internal development programs, and returning capital to shareholders [36][37] Question: What contributed to the less seasonality observed in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to a strong start in Q1 [42][43] Question: Will the upcoming shingles data release be sufficient for a go/no-go decision? - Management clarified that while the data is important, a more comprehensive data package will be needed for a pivotal program decision [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they feel insulated from immediate changes and have had positive interactions with the FDA [50][51] Question: How does the Lyme vaccine compare to competitors? - Management believes their Lyme vaccine can establish a leading market share position due to a more approachable dosing regimen compared to competitors [59][60] Question: Is there an explanation for potentially slower growth in HEPLISAV B revenue? - Management stated that year-over-year comparisons are more appropriate and they expect continued growth in market share [70][71]

Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase compared to the previous year [5][14] - Total revenues for the first quarter reached $68 million, up 34% year over year [26] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year, with expectations of approximately 80% for the full year 2025 [26] - GAAP net loss for the first quarter was $96 million, compared to a net loss of $9 million in the first quarter of the previous year, primarily due to debt refinancing accounting treatment [28][29] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [29] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a significant year-over-year growth of approximately 70% in the first quarter [14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [16] - The company executed over 85% of its $200 million share repurchase program as of May 5, 2025 [11][30] Market Data and Key Metrics Changes - The total market dose volume for hepatitis B vaccines increased approximately 16% year over year [13] - The company anticipates HEPLISAV B market opportunity to peak at over $900 million by 2030, capturing at least 60% market share [17] Company Strategy and Development Direction - Dynavax aims to leverage its vaccine adjuvant technology, CpG 1018, to advance its development pipeline, including shingles and plague vaccine programs, as well as new programs in pandemic influenza and Lyme disease [5][9][10] - The company maintains a disciplined approach to capital allocation while evaluating external opportunities to generate long-term growth [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top half of the annual revenue guidance range for HEPLISAV B due to strong early performance [5][32] - The company expects continued market share gains throughout 2025, supported by strong growth in retail and other key customer segments [17] Other Important Information - The company plans to initiate a phase one/two trial for its pandemic influenza adjuvant program in the coming weeks [9][24] - The Lyme disease vaccine program is expected to enter clinical trials in 2027, with a focus on fewer doses or less frequent boosters compared to current candidates [10] Q&A Session Summary Question: Why not officially raise the lower end of guidance if confidence in hitting the upper half? - Management stated it is prudent to maintain the overall guidance range as the year is only one quarter in [35] Question: How does capital allocation and business development fit into the long-term strategy? - Management emphasized a balanced strategy focusing on leveraging core assets while also returning capital to shareholders through share buybacks [36][38] Question: What contributed to less seasonality in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to growth [42] Question: Will the upcoming shingles data release be sufficient for a go/no-go decision? - Management clarified that while the data is important, a more comprehensive data package will be needed for pivotal trial decisions [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they have not faced significant issues and expect to engage with the FDA at the appropriate stages [50][56] Question: How does the company view the competitive landscape for the Lyme vaccine? - Management believes their product profile will support a leading market share position due to a more approachable dosing regimen [58]