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FDA authorizes Novavax's updated Covid vaccine, paving way for fall rollout
CNBC· 2024-08-31 03:29
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 circu ...
Wall Street Predicts That This Stock Could Skyrocket by 65%: Time to Buy?
The Motley Fool· 2024-08-24 23:20
Don't be too quick to jump on the Wall Street bandwagon. It's been a great year for Novavax (NVAX 0.25%). The biotech is up by 150% since January. However, analysts see even more upside for the vaccine maker. The consensus estimate of $20 a share implies a 65% increase over its current stock price, not too shabby for a company that, not too long ago, seemed to be not too far from bankruptcy. Can Novavax maintain its momentum? Let's find out if the biotech can hit the street's price target within the next 12 ...
Novavax: Staying Long Despite Coming Up Short In Q2
Seeking Alpha· 2024-08-13 20:27
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 ...
Novavax Plunges on Earnings Miss: Falling Knife or Buying Opp?
MarketBeat· 2024-08-12 20:56
Novavax Inc. NASDAQ: NVAX is a biotechnology company that focuses on developing and commercializing vaccines for serious infectious diseases. Its most significant vaccine, Nuvaxovid, is for COVID-19. The hype surrounding the potential for Nuvaxovid drove Novavax shares as high as $331.68 in February 2021. However, the reality of missteps resulting in being "late to the party" caused shares to crater to $3.53 by February 2024. Shares have since surged as high as $23.86 in June 2024 on a $1.2 billion licensin ...
Novavax (NVAX) Lags on Q2 Earnings & Sales, Cuts '24 Outlook
ZACKS· 2024-08-10 00:10
Novavax (NVAX) posted earnings per share of 99 cents in second-quarter 2024, missing the Zacks Consensus Estimate of $1.82. However, earnings rose 71% year over year. Revenues in the quarter amounted to $415.5 million, also missing the Zacks Consensus Estimate of $453.7 million. The top line declined 2% on a year-over-year basis. Quarter in Detail In the reported quarter, the company recorded $19.9 million in product sales compared with $285.2 million in the year-ago quarter. While this reported figure did ...
Novavax(NVAX) - 2024 Q2 - Earnings Call Transcript
2024-08-09 00:33
Novavax, Inc. (NASDAQ:NVAX) Q2 2024 Results Conference Call August 8, 2024 8:30 AM ET Company Participants Erika Schultz - Senior Director of Investor Relations John Jacobs - President and Chief Executive Officer John Trizzino - President and Chief Operating Officer Dr. Bob Walker - Chief Medical Officer and Interim Head of Research and Development Jim Kelly - Chief Financial Officer and Treasurer Conference Call Participants Roger Song - Jefferies Mayank Mamtani - B. Riley Securities Alec Stranahan - Bank ...
Novavax (NVAX) Misses Q2 Earnings and Revenue Estimates
ZACKS· 2024-08-08 22:15
Novavax (NVAX) came out with quarterly earnings of $0.99 per share, missing the Zacks Consensus Estimate of $1.82 per share. This compares to earnings of $0.58 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -45.60%. A quarter ago, it was expected that this vaccine maker would post a loss of $1.04 per share when it actually produced a loss of $1.05, delivering a surprise of -0.96%. Over the last four quarters, the company has ...
Novavax Reports Second Quarter 2024 Financial Results and Operational Highlights
Prnewswire· 2024-08-08 20:02
财务成果 - 2024年第二季度总营收4.15亿美元相比2023年同期的4.24亿美元有所下降其中包括来自赛诺菲协议的3.91亿美元 [12] - 2024年第二季度销售成本为4600万美元低于2023年同期的5600万美元 [12] - 2024年第二季度研发费用为1.07亿美元低于2023年同期的2.19亿美元 [12] - 2024年第二季度销售管理费用为1.01亿美元高于2023年同期的9400万美元 [12] - 2024年第二季度净利润为1.62亿美元高于2023年同期的5800万美元 [12] - 截至2024年6月30日现金等为11亿美元相比2023年12月31日的5.84亿美元有所增加 [12] 赛诺菲合作 - 赛诺菲将从2025年1月1日起承担诺瓦瓦克斯在美国欧洲等地新冠疫苗的主要商业责任 [5] - 已收到赛诺菲5亿美元预付款和约7000万美元的股权投资 [5] - 诺瓦瓦克斯有资格因相关活动获得至多7亿美元的里程碑付款及特许权使用费等 [5] 技术平台 - 计划在2024年第四季度启动新冠 - 流感联合疫苗和单独流感疫苗候选的3期免疫原性试验预计2025年中期获得数据 [6] - 正在进行项目优先级排序活动以确定公司的主要项目组合 [6] 成本削减 - 2024年第二季度研发和销售管理费用较2023年同期降低约34% [7] - 准备启动额外成本削减计划目标是2025年全年研发和销售管理费用低于5亿美元2026年低于3.5亿美元 [8] 新冠疫苗 - 已向美国FDA和EMA提交2024 - 2025年版新冠疫苗的授权申请 [1] - 预计在2024 - 2025年疫苗季开始时将更新后的新冠疫苗推向市场 [9] - 在美国已提交EUA修正案并按FDA指导生产预充式注射器版疫苗 [10] - 在全球决定在欧洲部分国家进行有针对性的商业推广 [11] 会议相关 - 公司将于美国东部时间8月8日上午8:30举行电话会议 [1][15]
Novavax(NVAX) - 2024 Q2 - Quarterly Report
2024-08-08 19:37
COVID-19疫苗开发与生产 - 公司正在开发更新版COVID-19疫苗NVX-CoV2705,并已向美国FDA、欧洲EMA、英国MHRA和加拿大卫生部提交申请[161] - 公司正在开发COVID-19和流感联合疫苗候选药物,以及独立的季节性流感疫苗候选药物,计划于2024年第四季度启动III期临床试验[164] - 公司的重组计划包括更加专注于COVID-19疫苗项目,包括原型疫苗NVX-CoV2373、变异株疫苗NVX-CoV2601和更新版NVX-CoV2705[24] - 公司正在努力扩大COVID-19疫苗在不同年龄人群的适用范围,并推动各国政府和监管机构的政策支持[173] - 公司的COVID-19疫苗在美国的生物制品许可申请已被FDA受理,预计2025年4月做出审批决定[162] - 公司正在寻求全球范围内对2024-2025年配方的JN.1 COVID疫苗的授权[174] - 公司正在进行临床试验以扩大COVID-19疫苗在青少年和儿童适应症的适用范围[177] - 公司预计将在2024-2025疫苗接种季节开始前向市场提供更新后的COVID-19疫苗[192,193] 疫苗技术平台与合作 - 公司的基于蛋白质的纳米颗粒疫苗技术和专有的Matrix-M佐剂有利于开发针对呼吸道和新发传染病的疫苗候选药物[166,167,168] - 公司的Matrix-M佐剂正被用于其他公司开发的疫苗,如疟疾疫苗R21/Matrix-M和其他预临床项目[169,170] - 公司与赛诺菲签订合作协议,共同开发和销售COVID-19疫苗,包括未来针对季节性变异株的更新版疫苗[163] - 公司与Sanofi签署合作协议,Sanofi将从2025年1月1日起负责公司2024-2025年配方COVID-19疫苗在美国、欧洲和其他主要市场的主要商业化责任[186] 财务表现 - 2024年第二季度总收入为5.09亿美元,同比增长0.8%[226] - 2024年第二季度产品销售收入为1.02亿美元,同比下降63.2%[226,228] - 2024年第二季度许可、版税和其他收入为4.07亿美元,同比增长12.6倍[226,232] - 2024年第二季度研发费用为1.07亿美元,同比下降51.3%[215,216,217] - 2024年第二季度销售、一般及管理费用为1.01亿美元,同比增长8.1%[218] - 2024年第二季度净利润为1.62亿美元,同比增长79.9%[223,224] - 研发费用从2023年上半年的4.666亿美元下降到2024年上半年的1.996亿美元,主要是由于与冠状病毒疫苗开发活动相关的支出减少[236][237] - 销售、一般及管理费用从2023年上半年的2.062亿美元下降到2024年上半年的1.881亿美元,主要是由于采取了某些成本控制措施来减少运营支出[238] - 2024年上半年的净利润为1483万美元,而2023年上半年为净亏损2.359亿美元,主要是由于研发费用的减少[242][243] 重组与成本控制 - 公司正在优化组织架构,集中资源于与赛诺菲的合作过渡、III期联合疫苗和独立流感疫苗项目以及更新版COVID-19疫苗的交付[165] - 公司正在进行成本削减计划,以创建更精简和敏捷的组织,并加快研发重点[190,191] - 公司正在采取重组和成本削减措施,并可能通过额外的股权和债务融资、合作、战略联盟等方式筹集资金[245][246] 合同变更与风险 - 公司与澳大利亚政府签订的疫苗采购协议可能会因为无法及时获得监管批准而导致合同金额减少2.4亿美元[256] - 公司与新西兰政府的APA合同被终止,可能损失约1.25亿美元的合同价值[257] - 与加拿大政府的APA合同可能被终止,约2.24亿美元的合同价值可能不再可用[258] - 与英国政府的疫苗供应协议被修订,公司需要偿还1.125亿美元的预付款[260][261] - 与Gavi的APA合同被终止,公司需支付4.75亿美元的和解款[262][263] - 公司面临汇率波动风险,10%汇率下跌可能导致股东权益减少5,720万美元[274][275] 其他 - 公司正在继续优化前期候选疫苗,包括RSV疫苗和新型H5N1禽流感疫苗[175] - 公司正在评估Matrix-M™佐剂增强新旧疫苗免疫反应的潜力[175] - 公司与FDA互动,为联合流感和单独流感疫苗候选产品的III期临床试验做准备[180,181] - 公司通过股票发行和与Sanofi的股票认购协议筹集了资金[195,196,198] - 公司获得CEPI的无息贷款支持,未来销售收入可用于偿还贷款[264][265] - 公司2024年6月30日现金及等价物为11亿美元,较2023年12月31日增加5.17亿美元[267][268] - 公司经营活动现金流为2.307亿美元,较上年同期大幅改善[269] - 公司认为未来12个月内有足够资金维持持续经营[272] - 公司的可转换高级无担保票据具有固定利率,公司没有其他重大债务,因此认为借款活动不会面临重大利率风险[279]
Novavax (NVAX) Registers a Bigger Fall Than the Market: Important Facts to Note
ZACKS· 2024-08-02 06:47
In the latest market close, Novavax (NVAX) reached $12.57, with a -1.87% movement compared to the previous day. The stock's performance was behind the S&P 500's daily loss of 1.37%. On the other hand, the Dow registered a loss of 1.21%, and the technology-centric Nasdaq decreased by 2.3%. The vaccine maker's shares have seen an increase of 2.07% over the last month, surpassing the Medical sector's gain of 0.74% and the S&P 500's gain of 1.11%. Investors will be eagerly watching for the performance of Novava ...