Doses of Novavax's 2024-2025 Formula COVID-19 vaccine now available at thousands of locations nationwideNovavax's updated vaccine is the only protein-based option available in the U.S. this fall for individuals aged 12 and olderGAITHERSBURG, Md., Sept. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) to prevent COVID-19 ...

The biotech continues to earn important wins, but is it enough?Vaccine maker Novavax (NVAX -3.01%) is having a good year. In May, the company announced a lucrative partnership with French biotech giant Sanofi (SNY -1.24%), sending its stock price soaring. Novavax has made quite a comeback for a company that raised doubts about its ability to stay in business just 18 months ago. But Novavax isn't done. The biotech just announced a regulatory win that has some investors excited. Let's find out whether Novavax ...

文章核心观点 - 公司拥有成熟的重组蛋白纳米颗粒疫苗技术和Matrix-M佐剂技术,已有多款商业化产品和临床管线 [1][2][3][4] - 公司与Sanofi达成重要合作,获得5亿美元前期付款和7000万美元股权投资,未来有望获得多达10亿美元的里程碑付款和长期的特许权使用费收入 [5][6][7] - 公司正在推进流感和流感新冠联合疫苗的III期临床试验,预计明年中期有结果,并计划寻求合作伙伴 [9][10][11] - 公司正在探索将Matrix-M佐剂技术应用于其他疫苗,以提升免疫原性,并正在推进RSV和H5N1疫苗的临床前研究 [12][13][14] - 公司正在大幅降低成本结构,预计到2026年R&D和销售费用将降低80% [14][15] - 公司新冠疫苗已获得美国紧急使用授权,并将在本季度投放市场,预计销售额将达3.25亿美元 [15][16][17][18][19]

会议主要讨论的核心内容 公司概况和技术平台 - 公司在过去几年经历了令人惊叹的转型 [3] - 公司的核心技术包括重组蛋白纳米颗粒疫苗技术和Matrix-M佐剂技术 [4] - 公司已有两款商业化产品:新冠疫苗和疟疾疫苗 [5] - 公司还在研发流感疫苗、流感+新冠联合疫苗、RSV疫苗和H5N1疫苗等 [5] Sanofi合作协议 - 这是一项重大的合作协议,可能为公司带来数十亿美元的潜在收益 [5][6][7] - 协议包括:授权Sanofi销售公司的单独新冠疫苗、授权Sanofi将公司新冠疫苗与其他疫苗如流感疫苗联合开发、授权Sanofi使用公司的Matrix佐剂技术 [6] - 协议条款包括:5亿美元的前期付款、7000万美元的股权投资,以及后续的里程碑付款和royalty [7] 流感+新冠联合疫苗 - 公司的流感+新冠联合疫苗在II期临床试验中显示出非劣效性和统计学上的优势 [10] - 公司计划在今年秋季启动III期临床试验,并寻求合作伙伴来推进后续的监管申报和商业化 [11] 技术平台的进一步应用 - 公司正在探索将Matrix-M佐剂技术应用于其他疫苗,如流感疫苗和肺炎球菌疫苗,以提升免疫原性 [12][13] - 公司还在推进RSV疫苗和H5N1疫苗的临床前研究 [14] 成本管控 - 公司正在通过多种措施来大幅降低R&D和销售费用,到2026年将其控制在3.5亿美元以下 [14][15] - 主要措施包括:完成商业化活动、出售捷克生产基地等 [15] 新冠疫苗在美国的推广 - 公司新冠疫苗已获得美国紧急使用授权,并于上周开始向药店配送,本周将开始接种 [16] - 公司已与主要零售商达成合作,疫苗将主要在零售渠道销售 [16] - 公司的新冠疫苗已经过更新,与当前流行株具有良好的抗原相似性 [17] 财务指引和里程碑 - 2022年总收入预计700-800百万美元,其中授权金、royalty等425百万美元,产品销售325百万美元 [18][19] - 2022年R&D和销售费用预计700-750百万美元 [19] - 未来重点里程碑包括:完成Sanofi合作、推进流感和联合疫苗III期试验、推出新的研发管线 [20]

会议主要讨论的核心内容 - 公司拥有四大支柱驱动长期价值:1)与Sanofi的交易带来大量潜在现金流[4]; 2)公司的后期管线,包括独立的流感疫苗和流感-新冠联合疫苗[4]; 3)利用Matrix平台进行业务拓展[4]; 4)公司自身管线的开发[4] - Sanofi交易的主要条款包括:5亿美元的前期付款、7000万美元的股权投资,以及针对新冠疫苗和联合疫苗的7亿美元里程碑付款和相关royalty[7][9] - Sanofi还可以利用公司的Matrix平台改善现有疫苗或开发新疫苗,公司可获得最高2.1亿美元的里程碑付款和相关royalty[7] - Matrix-M是一种佐剂,可以增强体液和细胞免疫反应,有望提高现有疫苗的免疫原性和成本效益[11][12][14] - 公司正在进行流感-新冠联合疫苗的III期免疫原性试验,预计2025年中期有重要数据读出[16][17] - 公司正在大幅降低运营成本,2022年R&D和SG&A为17亿美元,到2026年将降至不到3.5亿美元,实现盈利[20] 问答环节重要的提问和回答 - 分析师对公司CEO John Jacobs在2023年初上任后推动的战略转型表示认可[5] - 分析师对Matrix-M佐剂的潜力表示认可,包括提高免疫原性、降低成本等优势[10][13][14] - 分析师对公司实现盈利的目标表示认可,认为这将吸引关注现金流的投资者[18][19][21] - 公司表示新冠疫苗Nuvaxovid已于8月底获得美国紧急使用授权,并已开始向零售药店供货[24][25]

GAITHERSBURG, Md., Sept. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that it will participate in two upcoming investor conferences.H.C. Wainwright 26th Annual Global Investment Conference: Fireside Chat Date: Monday, September 9, 2024 Time: 3:30 – 4:00 p.m. Eastern Time (ET) Location: New York City, New York Moderator: Vernon Bernardino, Managing Director, Senior Healthcare Analyst Novavax particip ...

Novavax (NVAX) announced that the FDA granted emergency use authorization (EUA) to an updated version of its protein-based COVID-19 vaccine for individuals aged 12 years and older.Following this nod, Novavax’s updated vaccine is the only non-mRNA vaccine option available to people in the United States. Management expects pre-filled syringes of the vaccine to be available across the country.This authorization comes just a week after the agency approved/authorized updated the mRNA-based COVID-19 vaccines of P ...

Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S.Novavax's vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use ...

A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022.The Food and Drug Administration authorized Novavax's updated protein-based Covid vaccine for emergency use in people ages 12 and up on Friday, paving the way for the shot to compete with Pfizer and Moderna's jabs this fall and winter. Novavax's vaccine targets the highly contagious omicron subvariant JN.1, which began circulating widely in the U.S. earlier this year. JN.1 only accounted for 0.2% of cases circul ...

MCCAIG It has been less than a month since my last Novavax (NASDAQ:NVAX) article, where I discussed partnership with Sanofi (SNY) and updates on their COVID-19 and H5N1 bird flu vaccine programs. Those updates forced me to revise my NVAX strategy to account for upcoming catalysts and the possibility of a sustained rally. Well, that rally turned into a malaise fade over the past few weeks. However, the ticker has experienced a shot of volatility over the past few trading sessions after the company released t ...