EMERYVILLE, Calif., July 23, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report second quarter 2024 financial results on Tuesday, August 6, 2024, after the U.S. financial markets close.Dynavax will host a conference call and live audio webcast on Tuesday, August 6, 2024, at 4:30 p.m. ET/1:30 p.m. PT.The live audio webcast may be accessed through the "Events & Presentations" page on ...

EMERYVILLE, Calif., June 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster), a debilitating disease caused by the varicella-zo ...

EMERYVILLE, Calif. , May 28, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at the following upcoming investor conferences during the month of June: William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 1:20 p.m. CT Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10 at 4:00 p.m. ET The presentations will ...

EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support ...

财务数据和关键指标变化 - HEPLISAV-B净产品收入同比增长10%至4800万美元 [31] - HEPLISAV-B毛利率约77%,较上年同期66%有显著改善 [32] - 公司预计2024年HEPLISAV-B毛利率约80% [37] 各条业务线数据和关键指标变化 - HEPLISAV-B在零售药房和医疗网络(IDN)两大关键细分市场的市场份额均有所提升 [16] - 公司预计2024年HEPLISAV-B销售收入将达2.65亿-2.8亿美元 [20][37] - 公司预计未来几年成人乙肝疫苗市场将以10%-15%的年增长率扩大,HEPLISAV-B将获得大幅提升的市场份额 [21] 各个市场数据和关键指标变化 - 2024年第一季度,成人乙肝疫苗市场略有下降,受延长的感冒流感季节影响 [15] - HEPLISAV-B在第一季度的市场份额达41%,较上年同期37%有所提升 [16] - 公司预计未来几年成人乙肝疫苗市场将超过8亿美元,HEPLISAV-B有望占据主导地位 [11] 公司战略和发展方向及行业竞争 - 公司将继续推动HEPLISAV-B在成人乙肝疫苗市场的领导地位 [10][20][21] - 公司正在推进创新疫苗管线,包括带状疱疹疫苗、百白破疫苗等 [23][26][29] - 公司正在评估在传染病领域进行外部并购的机会,以进一步丰富产品组合 [13] 管理层对经营环境和未来前景的评论 - 公司对HEPLISAV-B的长期市场机会保持信心,预计2024年将再创销售纪录 [9][20] - 公司认为成人乙肝疫苗市场有巨大的未开发空间,HEPLISAV-B有望获得主导地位 [11] - 公司对创新疫苗管线的进展表示满意,未来将继续推进相关临床试验 [23][26][29] 问答环节重要的提问和回答 问题1 **Matthew Phipps 提问** 零售市场份额从第四季度的58%下降至第一季度的55%,是否有什么特殊原因? [42] **Donn Casale 回答** 这主要是由于一些大客户的采购模式造成的正常波动,公司仍然预计未来将继续在零售和医疗网络(IDN)市场份额提升 [43] 问题2 **Paul Choi 提问** 公司如何设计带状疱疹疫苗的临床试验,如何考虑与竞品的差异化? [49] **Rob Janssen 回答** 公司将评估不同剂量的抗原和接种时间间隔,重点关注诱导CD4+T细胞反应,并将开发新的耐受性评估工具 [52][53][54] 问题3 **Phil Nadeau 提问** 公司是否预计未来成人乙肝疫苗市场的季节性波动会有所改善? [69] **Donn Casale 回答** 这还为时尚早,但零售客户已经更好地准备应对呼吸道疫苗的推出,未来可能会有所改善 [70][71]

Dynavax Technologies (DVAX) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -40%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced break-even earnings, delivering a surprise of 100%.Over the last four quarters, t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-34207 Dynavax Technologies Corporation (Exact name of registrant as specified in its charter) Delaware 33-0728374 (State or o ...

Exhibit 99.1 Dynavax Reports First Quarter 2024 Financial Results and Provides Business Updates • HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024 • Reaffirming full year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million • Announces U.S. FDA clearance of IND application to initiate Phase 1/2 trial of Z-1018 shingles program • Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, CA – May 8, 2024 – Dynavax Tec ...

公司概况 - Dynavax Technologies Corporation是一家位于加利福尼亚Emeryville的商业阶段生物制药公司，专注于开发利用其CpG 1018佐剂技术的疫苗来对抗传染病[2] 财务表现 - 公司的核心资产HEPISLAV-B在2023财年销售额增长69%，达到2.133亿美元，使公司实现了现金流的正值，尽管由于Covid-19疫苗中CpG 1018的收入损失[1] - 公司在2023财年几乎实现了盈亏平衡，从运营活动中获得了1.006亿美元的现金，截至2023年底，现金和投资达到7.423亿美元，有足够的资金进行收购[15] 产品情况 - HEPISLAV-B是一种两剂量成人乙型肝炎疫苗，由CpG 1018提供动力，于2017年获得FDA批准，2023年销售额达2.133亿美元，占据了美国乙型肝炎疫苗市场42%的份额[6] - 公司的CpG 1018佐剂被广泛应用于许多Covid-19疫苗中，销售额在2022年达到5.877亿美元，2021年达到3.752亿美元，但在2023年未实现任何收入[5] - 公司的研发方向包括扩大CpG 1018疫苗适应症，涉及带状疱疹、百日咳和鼠疫等领域[8] - Z-1018是公司的一种疫苗，用于治疗带状疱疹，已在动物试验中表现出高抗体和CD4阳性T细胞疫苗反应率，预计将在2025年公布数据[10] - Tdap-1018是公司另一种疫苗，用于治疗百日咳，预计将在2024年进入第二阶段研究，以期产生比当前疫苗更持久的免疫反应[11] - 公司还与国防部合作开发一种包含CpG 1018的rF1V鼠疫疫苗，预计2024年产生初步数据[13] 市场表现 - 公司的股价在2021年11月触及21.39美元的高点，但由于Covid-19疫苗销售收入不再是其财年2023和2024的特征，股价回落至12至15美元的范围[14] - 分析师普遍看好公司的前景，预计2024财年公司将实现0.26美元的每股收益，3470万美元的营收，2025财年将实现0.51美元的每股收益，3.47亿美元的营收[16]

EMERYVILLE, Calif., Feb. 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at TD Cowen's 44th Annual Health Care Conference on Monday, March 4 at 10:30 a.m. ET. The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/even ...