Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

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, Calif., May 8, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended March 31, 2024. "The first quarter of 2024 saw continued year-over-year growth in quarterly HEPLISAV-B net product revenue. As we expected, growth in the U.S. hepatitis B vaccine market was slightly down during the first quarter compared to the fourth quarter due to an extended cough, cold and flu season which reduced the number of vaccination opportunities – a dynamic observed across other non-respiratory vaccine markets beyond hepatitis B. Despite this start to the year, we remain very encouraged about the hepatitis B market opportunity, both in 2024 and longer term. We are now seeing a pickup in the market as providers have begun to shift to non-respiratory vaccine campaigns in recent weeks, our retail pharmacy partners are expected to meet their demand expectations for this year, and several top IDN systems are planning to launch new hepatitis B focused initiatives. The U.S. adult hepatitis B vaccine opportunity remains significant with over 130 million patients eligible, one of the largest addressable patient populations in the U.S., and the vast majority remaining unvaccinated," said Ryan Spencer, Chief Executive Officer of Dynavax. "We're also excited for several upcoming milestones from our novel vaccine pipeline, including the planned initiation of a mid-stage clinical trial in shingles this year, and data readouts from our plague and shingles vaccine programs expected across 2024 and 2025. In addition to this continued execution, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to accelerate growth and further diversify our portfolio." BUSINESS UPDATES HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S. HEPLISAV-B vaccine achieved net product revenue of $47.8 million for the first quarter of 2024, an increase of 10% compared to $43.5 million for the first quarter of 2023. HEPLISAV-B total estimated market share in the U.S. increased to approximately 41%, compared to approximately 37% at the end of the first quarter 2023. HEPLISAV-B estimated market share in the retail pharmacy segment increased to approximately 55%, compared to approximately 49% at the end of the first quarter of 2023. HEPLISAV-B estimated market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment increased to approximately 55%, compared to approximately 49% at the end of the first quarter 2023. A supplemental Biologic License Application (sBLA) for HEPLISAV-B vaccination of adults on hemodialysis is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date planned for May 13, 2024. Driven by the Centers for Disease Control and Prevention's Advisory Committee of Immunization Practices (ACIP) universal recommendation for adult hepatitis B vaccination, the hepatitis B vaccine market continues to expand in the U.S. and Dynavax believes the U.S. market has the potential to grow to over $800 million by 2027, with HEPLISAV-B well-positioned to achieve a majority market share. Clinical Pipeline Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018® adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use. Shingles vaccine program: Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older. In March 2024, Dynavax received clearance of its Investigational New Drug Application (IND) by the U.S. FDA for its novel shingles vaccine program, Z-1018. Dynavax plans to initiate a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix® in approximately 440 healthy adults aged 50 to 69. Dynavax plans to initiate the Phase 1/2 trial in the second quarter of 2024 and expects to report top line immunogenicity and safety data in the second half of 2025. Tdap vaccine program: Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap). Prior to advancing Tdap-1018 into a previously announced Phase 2 human challenge trial, Dynavax plans to evaluate the persistence of pertussis immunogenicity of Tdap-1018 through a long-term follow-up study of participants that completed a Phase 1 trial of a booster dose of Tdap-1018 compared to an active control. The extension study is expected to follow participants for up to approximately three years following initial vaccination. Top line results from the Phase 1 extension study are expected in the fourth quarter of 2024. Plague vaccine program: Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® currently in a Phase 2 clinical trial in collaboration with, and fully funded by, the U.S. Department of Defense. In March 2024, Dynavax and the U.S. Department of Defense executed a contract modification to add approximately $4 million to support CMC work for the plague vaccine candidate, with the agreement now totaling $38 million through 2025. Dynavax anticipates top line data from both the randomized, active-controlled Phase 2 clinical trial evaluating immunogenicity, safety, and tolerability, as well as the nonhuman primate challenge study of the plague vaccine candidate, in the fourth quarter of 2024. FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS Total Revenues and Net Product Revenue. Total revenues for the first quarter of 2024 were $50.8 million, compared to $46.9 million for the first quarter of 2023. HEPLISAV-B vaccine net product revenue was $47.8 million for the first quarter of 2024, compared to $43.5 million for the first quarter of 2023. Other revenue was $2.9 million for the first quarter of 2024, compared to $3.5 million for the first quarter of 2023. Other revenue primarily includes revenue from the plague vaccine agreement with the U.S. Department of Defense. Cost of Sales - Product. Cost of sales - product for HEPLISAV-B the first quarter of 2024 decreased to $11.0 million, compared to $14.7 million for the first quarter of 2023. The decrease was primarily due to lower per-unit manufacturing costs as the result of previous process improvements, partially offset by a $1.3 million inventory write-off charge recorded during the first quarter of 2024. Research and Development Expenses (R&D). R&D expenses for the first quarter of 2024 decreased to $13.5 million, compared to $13.6 million for the first quarter of 2023. The decrease was primarily driven by the timing of clinical development costs due to the completion of clinical trials in early 2023 and activities for planned clinical trials in 2024, partially offset by increases related to investments in our CpG 1018 preclinical and clinical collaborations. Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2024 increased to $44.1 million, compared to $36.5 million for the first quarter of 2023. The increase was primarily driven by increased headcount and other investments supporting our strategic growth, including an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B market share and maximize the opportunities presented by the ACIP's universal recommendation. Net Loss. GAAP net loss was $8.7 million, or $0.07 per share (basic and diluted) in the first quarter of 2024, compared to GAAP net loss of $24.3 million, or $0.19 per share (basic and diluted) in the first quarter of 2023. Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $723.5 million as of March 31, 2024. 2024 FINANCIAL GUIDANCE Dynavax is reaffirming the following full year 2024 financial guidance, based on the Company's current operating plan: HEPLISAV-B net product revenue between approximately $265 - $280 million, including approximately $3 million in ex-U.S. sales through commercialization partnership in Germany HEPLISAV-B gross margin of approximately 80% Research and development expenses between approximately $60 - $75 million Selling, general and administrative expenses between approximately $160 - $180 million Expect cash, cash equivalents and marketable securities to be higher as of December 31, 2024, compared to December 31, 2023 Conference Call and Webcast Information Dynavax will host a conference call and live audio webcast on Wednesday, May 8, 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 the "Investors" section of the Company's website at . A replay of the webcast will be available for 30 days following the live event. To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call. Important U.S. Product Information HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. For full U.S. Prescribing Information for HEPLISAV-B, click here. Important U.S. Safety Information (ISI) Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%). About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant with adjuvanted vaccine clinical programs for shingles and Tdap, and through global collaborations, currently focused on adjuvanted vaccines for COVID-19, plague, seasonal influenza and universal influenza. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our expected financial results and market share as of and for the year ended December 31, 2024, expectations regarding future growth and market share, the timing of IND filings, initiation and completion of clinical studies, expected timing for data readouts, and interaction with regulators. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that actual demand for our products may differ from our expectations, risks relating to our ability to commercialize and supply HEPLISAV-B, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies

2023年10月，美国免疫实践咨询委员会（ACIP）批准了2024年美国≥19岁成人疫苗推荐免疫程序。该程序每年发布一次，以整合和总结ACIP关于成人疫苗接种建议的更新，并协助医疗保健提供者实施当前的ACIP建议。ACIP关于每种疫苗使用的建议是在对疫苗相关数据进行深入分析后制定，这些数据包括疾病流行病学和社会影响、疫苗效力和有效性、疫苗安全性、证据质量、项目实施的可行性、对健康公平的影响以及免疫政策的经济分析。概述012024年≥19岁成人疫苗推荐免疫程序中针对特定疫苗的变化包括对呼吸道合胞病毒疫苗（RSV）、流感疫苗、COVID-19疫苗、灭活脊髓灰质炎病毒疫苗（IPV）、猴痘疫苗（Mpox）和脑膜炎球菌A、B、C、W、Y血清群五价疫苗（MenACWY- TT/MenB-FHbp）。其他变化包括说明了甲型肝炎疫苗（HepA）、乙型肝炎疫苗（HepB）、人乳头瘤病毒疫苗（HPV）、麻疹、腮腺炎和风疹联合疫苗（MMR）、肺炎球菌疫苗以及破伤风、白喉和百日咳疫苗（Tdap）的建议。01表1.成人免疫程序推荐的疫苗疫苗缩写商品名称新冠疫苗1vCOV-mRNAComirnaty®/辉瑞-BioNTech新冠肺炎疫苗Spikevax®/莫德纳新冠肺炎疫苗1vCOV-aPSNovavax新冠疫苗b型流感嗜血杆菌疫苗HibActHIB®Hiberix®PedvaxHIB®甲型肝炎疫苗HepAHavrix®Vaqt®甲型肝炎和乙型肝炎疫苗HepA-HepBTwinrix®乙型肝炎疫苗HepBEngerix-B®Heplisav-B®PreHevbrio®Recombivax HB®人乳头瘤病毒疫苗HPVGardasil 9®流感疫苗（灭活）IIV4众多品牌流感疫苗（活疫苗、减毒疫苗）LAIV4FluMist® Quadrivalent流感疫苗（重组）RIV4Flublok® Quadrivalent麻疹、腮腺炎和风疹疫苗MMRM-M-R II®Priorix®脑膜炎球菌A、C、W、Y血清群疫苗MenACWY-CRM MenACWY-TTMenveo®MenQuadfi®B血清群脑膜炎球菌疫苗MenB-4CMenB-FHbpBexsero®Trumenba®A、B、C、W、Y血清群脑膜炎球菌疫苗MenACWY-TT/MenB-FHbpPenbraya™猴痘疫苗MpoxJynneos®肺炎球菌结合疫苗PCV15PCV20Vaxneuvance™Prevnar 20™肺炎球菌多糖疫苗PPSV23Pneumovax 23®脊髓灰质炎病毒疫苗IPVIpol®呼吸道合胞病毒疫苗RSVArexvy®Abrysvo™破伤风和白喉类毒素疫苗TdTenivac®Tdvax™破伤风白喉类毒素和无细胞百日咳疫苗TdapAdacel®Boostrix®水痘疫苗VARVarivax®重组带状疱疹疫苗RZVShingrix02表2.2024年美国按年龄组分列的推荐成人免疫接种时间表03 表3.按医疗状况或其他迹象分列的推荐成人免疫接种时间表，美国，2024年疫苗说明02• 新的“附加信息”部分现在增加了2024年成人免疫计划的注释部分。• COVID-19：现在建议所有成年人至少接种1剂更新的（2023-2024年组分）COVID-19疫苗。所需的剂次数和剂次间隔可能因患者既往疫苗接种史、免疫功能低下状态和使用的疫苗产品而异。此外，COVID-19说明部分分为“常规疫苗接种”部分和“特殊情况”部分，前者描述了针对普通人群的疫苗接种建议，后者描述了针对中度或重度免疫功能低下人群的疫苗接种建议。• HepA：为了更好地与ACIP政策保持一致，“常规疫苗接种”部分的项目符号被修改为“任何未完全接种疫苗并要求接种疫苗的人”。• HepB：在“常规疫苗接种”部分，在描述针对≥60岁人群的基于风险的疫苗接种建议的项目符号中添加了额外的背景和细节。此外，在“常规疫苗接种”部分的末尾增加了一个注释，描述了对≥60岁糖尿病患者的共同临床决策建议。• HPV：在“常规疫苗接种”部分，删除了关于未按免疫程序完成接种的指南。当使用推荐的接种间隔完成全程HPV疫苗接种后，不建议额外剂次。• 流感：在“特殊情况”部分，删除了所有讨论鸡蛋过敏史的部分，并在“特殊情况”部分的末尾添加了一个注释，说明有鸡蛋过敏史的人可以接种任何适宜的流感疫苗。最后，删除了描述吉兰-巴雷综合征的部分。• MMR：对“常规疫苗接种”部分进行了细微更改，以提高语言清晰度。• 脑膜炎球菌：添加了资源链接，以帮助医疗保健提供者共享MenB疫苗接种的临床决策建议。有关使用新许可的五价脑膜炎球菌疫苗（Penbraya）的信息在脑膜炎球菌注释部分的末尾提供。• 猴痘：猴痘疫苗接种是成人疫苗推荐免疫程序注释部分的新内容。列出了需要常规接种Jynneos疫苗的危险因素。有关在医疗保健提供者和孕妇中使用Jynneos的要点在Mpox注释部分的末尾提供。• 肺炎球菌：在“常规疫苗接种”和“特殊情况”部分进行了细微编辑，以明确肺炎球菌疫苗的指导和最低间隔。• 脊髓灰质炎病毒：在“常规疫苗接种”部分添加了其他背景信息。本节现在呼吁未接种疫苗或未完全接种疫苗的成年人完成3剂IPV基础免疫。      增加了一份声明，指出大多数在美国出生和长大的成年人可以假设他们小时候接种了脊髓灰质炎疫苗。“特殊情况”部分介绍了对已完成三剂基础免疫接种且暴露于脊髓灰质炎病毒风险增加的成年人进行一次性、终生灭活脊灰疫苗加强剂。• 呼吸道合胞病毒：今年增加了一个新的呼吸道合胞病毒注释部分。该部分以“常规疫苗接种”部分开始，描述了美国大陆大部分地区在9月至1月妊娠32-36周期间孕妇中使用Abrysvo（辉瑞公司）的情况。     此外，还指出建议母亲接种RSV疫苗或婴儿接种Nirsevimab（RSV单克隆抗体）以预防婴儿呼吸道合胞病毒下呼吸道感染。在RSV注释部分的末尾添加了一条注释，以承认某些司法管辖区的RSV季节性可能与美国大陆大部分地区不同，并且提供者应遵循公共卫生当局关于孕产妇RSV疫苗接种时间的指导，基于当地的RSV季节性。     “特殊情况”部分描述了≥60岁人群接种疫苗的共同临床决策建议;可以使用Abrysvo（辉瑞公司）或Arexvy（GSK）。      此外，还添加了一个资源链接，以帮助医疗保健提供者共享RSV疫苗接种的临床决策建议。      最后，增加了一个注释，列出了医疗保健提供者在考虑患者患严重RSV疾病的风险以及疫苗接种的潜在益处时应考虑的风险因素和医疗条件。• Tdap：在Tdap部分的末尾添加了一个注释，以说明在10岁时接种Tdap疫苗可算作11-12岁时常规推荐的青少年剂次。参考文献：Murthy N, Wodi AP, McNally VV, Daley MF, Cineas S. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:11–15. DOI：http://dx.doi.org.libproxy1.nus.edu.sg/10.15585/mmwr.mm7301a3识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。