Dynavax(US:DVAX)2022-05-06 00:17Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $114 million, representing a 37% increase year-over-year [7][32] - HEPLISAV-B net sales reached $21 million, up 151% from $8 million in Q1 2021 [17][32] - CpG 1018 adjuvant revenues were $92 million, a 23% increase from $75 million in the same period last year [32][12] - GAAP net income for Q1 2022 was $33 million, or $0.26 per share basic, compared to $900,000 or $0.01 per share in Q1 2021 [35][36] - Cash, cash equivalents, and investments totaled $503 million at the end of Q1 2022 [37] Business Line Data and Key Metrics Changes - HEPLISAV-B's market share increased to 26%, up from 14% year-over-year, with field targeted market share rising to 33% from 27% [17][21] - The hepatitis B market grew by approximately 27% year-over-year, while HEPLISAV-B grew by approximately 137% [20] Market Data and Key Metrics Changes - The CDC's ACIP recommended hepatitis B vaccination for all adults aged 19 to 59, significantly expanding the target market [21] - The market opportunity for HEPLISAV-B is estimated to grow to approximately $800 million by 2027 [22] Company Strategy and Development Direction - The company aims to leverage its strengths in commercial, manufacturing, and development to drive growth in HEPLISAV-B and CpG 1018 adjuvant supply [14][39] - The focus is on increasing awareness of the ACIP recommendation to drive market growth for HEPLISAV-B [9][23] - The company is advancing its clinical pipeline with new vaccine programs, including Tdap and shingles, utilizing the CpG 1018 adjuvant [13][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving annual revenue growth for both HEPLISAV-B and CpG 1018 adjuvant supply, anticipating a second consecutive year of profitability [14][58] - The company expects revenues of at least $550 million from the adjuvant supply business in 2022, with a strong pipeline supporting future growth [12][38] Other Important Information - The company has sufficient capital to support its core business without the need for additional funding [37] - Management highlighted the importance of the team’s commitment and execution in achieving the company’s goals [59] Q&A Session Summary Question: Trends in vaccine utilization from early in the quarter versus March - Utilization was down 23% for the entire quarter, with a significant turnaround observed in March [41][42] Question: Implementation of ACIP's recommendation - It is too early to assess the full impact, but the recommendation has created a market event for sales engagement [42][43] Question: Orders from Valneva and Clover - Orders have been placed in advance of approval, reflecting commitments from customers [45] Question: Market share gains from Q4 to Q1 - Market share was relatively flat from Q4 to Q1, but a positive trend was observed in March, indicating potential for future gains [46][48] Question: Flexibility in contracts amid changing market conditions - The company remains confident in its contracted revenue and continues to monitor the evolving COVID-19 environment [50][52] Question: Endemic market for COVID-19 vaccines - The company is cautious but optimistic about the potential for annual boosters and is waiting for more information on the evolving market [54] Question: Clinical proof of concept for pertussis - Key readouts will come from human and baboon challenge models, with data expected in late 2022 and 2023 [56]