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]

GAITHERSBURG, Md., May 1, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced it will report its first quarter 2025 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Thursday, May 8, 2025. Details of the event and replay are as follows: Conference call details: Date: May 8, 2025 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/43UHjFq Dial-in number: (800) 836-8184 (Domestic) or (+1) (646) 357-8785 (International) Webcas ...

TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses CHATHAM, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding C ...

CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company's presentation will be available under the Scientific P ...

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]

Vaxcyte (PCVX) is a clinical-stage biotech focused on developing vaccines to prevent or treat bacterial infectious diseases.In the past month, PCVX's shares have nosedived 56%. This downside came after Vaxcyte reported mixed results from a phase II study on its investigational pneumococcal conjugate vaccine (PCV) in healthy infants.Adding to this headwind, the broader biotech/drug sector is feeling the pressure from the resignation of a senior FDA official instrumental in driving biotech innovation, which h ...

Shares of Valneva (VALN) rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.The safety of the vaccine wil ...

Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2024 Earnings Conference Call February 20, 2025 4:30 PM ET Company Participants Paul Cox - Vice President, Investor Relations & Corporate Communications Ryan Spencer - Chief Executive Officer Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - Chief Financial Officer Conference Call Participants Matt Phipps - William Blair Roy Buchanan - Citizens Jonathan Miller - Evercore ISI Phil Nadeau - TD Cowen Ed White - H.C. Wa ...