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Moderna公司未来前景分析:FDA规定影响及股价风险评估

这是通过google Deep Research做的关于Moderna公司的研究报告。本人不对真实性和准确性负责。

Moderna的业务与产品线概览

近期业务发展与财务表现

Moderna公司在2024年实现了30亿至31亿美元的产品销售额1。此销售额主要来源于其COVID-19疫苗Spikevax,而其呼吸道合胞病毒(RSV)疫苗mRESVIA的销售贡献甚微1。这表明公司在很大程度上依赖于COVID-19疫苗的收入,但随着疫情进入地方性流行阶段,该收入预计将出现下滑。mRESVIA在其上市首年的销售表现不佳,正如1和2所强调的那样,这可能预示着公司在市场渗透方面面临初步挑战,并导致未来营收预期下调,管理层也承认对RSV疫苗市场过于乐观6。

截至2024年底,Moderna的现金及现金等价物和投资总额约为95亿美元1。如此强劲的现金储备为公司未来的研发活动和潜在的战略举措提供了重要的财务灵活性。这使得Moderna能够持续投资于其涵盖呼吸道病毒、罕见病、肿瘤和潜伏病毒等多个治疗领域的多元化产品线1,并可能寻求战略合作或收购以增强其产品组合和市场地位。正如9所述,公司有能力在不需要额外融资的情况下进行这些投资。

然而,Moderna预计2025年的收入将大幅下降,预计收入在15亿至25亿美元之间,且大部分收入将在下半年实现1。这反映出市场对COVID-19疫苗的需求预计将减少,以及新产品上市初期贡献有限。2025年营收预期的大幅下降突显了Moderna在从疫情驱动的销售额向更加多元化的产品组合过渡时所面临的挑战。正如2和3所示,收入集中在2025年下半年,这表明公司依赖潜在的监管批准和季节性疫苗销售,这为实现预测数据带来了一定的不确定性。

为应对营收下滑,Moderna计划在2025年削减10亿美元的现金运营支出,并在2026年进一步削减5亿美元1。这种积极的成本削减措施表明,在营收下降的情况下,公司正专注于提高盈利能力。正如1和5所详述,成本削减的目标包括销售成本、研发支出以及销售、一般和行政费用,这反映出公司正在进行全面的努力以提高效率。此举也表明公司认识到需要适应疫情后的市场环境,该环境的营收可能较低。

尽管采取了成本削减措施,Moderna预计到2025年底其现金和投资将约为60亿美元1。这表明即使削减了成本,2025年仍将出现显著的现金消耗。这表明,研发投资,特别是推进多元化产品线所需的投资,以及持续的运营支出,将在未来一年超过收入。尽管计划削减成本,但到2025年底现金余额从95亿美元降至60亿美元,这表明推进其产品线需要大量资金投入。

2024年末,Moderna为其下一代COVID疫苗(mRNA-1283)、高风险成人RSV疫苗(mRNA-1345)和流感/COVID联合疫苗(mRNA-1083)提交了三份生物制品许可申请(BLA)3。这些提交代表了近期产品批准和收入产生的重要机会。正如1、8、10和1所示,mRNA-1283的PDUFA目标日期为2025年5月31日,而mRNA-1345的PDUFA目标日期为2025年6月12日,这表明监管部门有望在2025年上半年做出决定。

产品线回顾

  • 呼吸道疫苗:
    • 下一代COVID-19疫苗 (mRNA-1283): III期数据积极,BLA已获FDA受理,PDUFA日期为2025年5月31日 1。
      • 洞察: 近期潜在批准可能提供一种改进的COVID-19疫苗选择,具有增强的稳定性和预填充注射器包装 12。
    • RSV疫苗 (mRESVIA, mRNA-1345): 已在美国、加拿大、欧盟、英国、澳大利亚等地区批准用于60岁以上成人;针对18-59岁高风险成人的sBLA已提交,PDUFA日期为2025年6月12日 1。
      • 洞察: 在与GSK和辉瑞现有RSV疫苗竞争激烈的市场中 6,扩大批准年龄范围将显著增加市场潜力。
    • 流感/COVID联合疫苗 (mRNA-1083): 在50岁以上成人中获得积极的III期免疫原性数据,已向FDA提交BLA 1。
      • 洞察: 联合疫苗的便利性可能会提高疫苗接种率并减轻医疗系统的负担 18。Moderna是首家报告流感/COVID联合mRNA疫苗III期积极数据的公司 18。
    • 季节性流感疫苗 (mRNA-1010): III期有效性研究正在进行中,重点是2024年提交流感/COVID联合疫苗的申请 1。
      • 洞察: Moderna优先考虑联合疫苗而非单独的流感疫苗的近期申请,可能是因为联合疫苗具有更大的市场机会和影响力 12。
  • 潜伏病毒疫苗:
    • 巨细胞病毒疫苗 (CMV, mRNA-1647): III期研究已完全入组,初步疗效数据未达到早期标准,最终数据预计在2025年公布 1。
      • 洞察: 有望在预防先天性巨细胞病毒感染(导致新生儿出生缺陷的主要原因)方面取得突破 1。
    • 诺如病毒疫苗 (mRNA-1403): III期研究正在进行中,有效性数据预计在2025年公布 1。
      • 洞察: 解决了全球主要的腹泻疾病负担 1。
  • 肿瘤治疗药物:
    • 个体化新抗原疗法 (INT, mRNA-4157): III期试验正在进行中,用于黑色素瘤和NSCLC的辅助治疗,并扩大研究到其他肿瘤类型 1。
      • 洞察: 个性化癌症疫苗代表着在对靶向疗法需求不断增长的市场中的重要长期增长机会 35。与默克的合作进一步加强了该项目 1。
  • 罕见病疗法:
    • 丙酸血症 (PA, mRNA-3927): I/II期研究正在进行中,正在生成注册试验数据 1。
      • 洞察: 解决了治疗选择有限的市场中严重的未满足医疗需求 1。
    • 甲基丙二酸血症 (MMA, mRNA-3705): II期,入选FDA START试点项目,关键研究设计已达成一致,预计于2025年上半年启动注册研究 1。
      • 洞察: 另一种具有显著未满足需求的罕见病,受益于FDA对加速开发的支助 62。

研发重点

Moderna将重点放在呼吸道病毒、罕见病、肿瘤和具有未满足需求的潜伏病毒上1。公司目标是在2027年前实现10种产品的批准,以推动销售增长并实现收入多元化1。Moderna正在实施产品组合优先排序和成本效率措施,目标是从2027年起每年减少11亿美元的研发支出12。公司还积极开展战略合作,例如与默克公司合作开发肿瘤治疗药物1。Moderna还在ESCMID 2025等科学会议上展示其研究成果1。

FDA监管环境

近期FDA行动与指南

FDA批准并授权了针对Omicron变异株KP.2的最新mRNA COVID-19疫苗(2024-2025配方),以更好地预防当前流行的变异株70。这确保了Moderna的COVID-19疫苗仍然具有相关性并获得使用授权。2023-2024配方的COVID-19疫苗已不再推荐使用76,这凸显了Moderna成功过渡到最新配方的必要性。FDA已受理Moderna下一代COVID-19疫苗(mRNA-1283)的BLA,PDUFA日期为2025年5月31日1,这表明该疫苗有望在近期获得批准,为改进的COVID-19疫苗选择提供了可能。FDA已受理Moderna高风险成人RSV疫苗(mRNA-1345)的BLA,PDUFA日期为2025年6月12日1,如果获得积极决定,将扩大Moderna RSV疫苗的市场。FDA授予赛诺菲流感和COVID-19联合疫苗候选药物快速通道资格77,这表明监管机构对联合疫苗的兴趣日益浓厚,可能有利于Moderna的mRNA-1083。FDA发布了关于加速计划的指南草案,包括药物和生物制品的加速批准,以及确定确证性试验是否正在进行的考虑因素78。这些指南可能会影响Moderna产品线候选药物(尤其是在肿瘤和罕见病领域)的批准途径。FDA在2024年的主要关注领域包括临床试验设计、加速计划和先进制造技术80,这些领域与Moderna的研发和生产工作直接相关。

对mRNA技术和疫苗的影响

包括特朗普总统周围人士在内的一些共和党人对mRNA疫苗技术越来越怀疑,一些州也提出了禁止或限制其使用的立法81。这可能会对基于mRNA的产品带来潜在的政治和公众认知挑战。FDA对最新mRNA COVID-19疫苗的持续审查和批准过程表明,监管机构继续接受该技术,尽管审查日益严格70。世界卫生组织(WHO)正在制定关于mRNA疫苗生产和质量控制的国际指南83,这可能导致mRNA产品监管实践的全球协调性更高。

FDA规定对Moderna未来发展的影响

开发时间表和审批途径

下一代COVID和RSV疫苗的BLA申请正在接受FDA审查,并有明确的PDUFA日期,表明2025年可能获得批准1。FDA的及时审查对于Moderna 2025年的收入预测及其抵消Spikevax销量下滑的能力至关重要。FDA关于加速批准的指南可能会加快Moderna个性化癌症疫苗(mRNA-4157)的审批途径,如果替代终点被认为合理可能预测临床益处78。在肿瘤学领域更快获得批准,这是Moderna的一个关键重点领域63,可能会在快速增长的市场中提供重要的竞争优势35。正如FDA指南强调的那样,加速批准后需要进行确证性试验,这将要求Moderna为这些研究分配资源和时间78。如果确证性试验在证明临床益处方面面临挑战,则可能导致完全批准延迟,尤其是在个性化癌症疫苗等复杂领域。

市场准入与竞争

FDA批准Moderna的流感/COVID联合疫苗可能会在呼吸道疫苗市场中提供竞争优势,尤其考虑到赛诺菲类似候选药物已获得快速通道资格77。便利性和提高依从性的潜力18可能会在庞大且不断增长的流感疫苗市场中推动市场份额85。在新政府领导下,FDA对疫苗研究设计和批准的潜在更严格要求(如7关于监管不确定性和92关于政策不确定性的建议)可能会对所有治疗领域的未来候选药物构成挑战。监管审查的加强可能会导致批准时间延长或需要更广泛的临床数据,从而可能影响Moderna在2027年前实现10种产品批准的目标的时间表。FDA对临床试验设计中真实世界证据的关注7可能为Moderna提供机会,简化某些适应症的开发过程,从而可能减少与传统临床试验相关的时间和成本。这对于评估疫苗和疗法在不同患者群体中的有效性以及了解其长期影响可能特别有益。

机遇与挑战

  • 机遇:
    • 优先审查凭证有可能加快关键产品线候选药物(如下一代COVID和RSV疫苗)的批准,从而更快地进入市场并产生收入1。
    • FDA对mRNA等创新疫苗平台的日益关注可能有利于Moderna的技术,用于开发针对各种疾病领域的新型疫苗和疗法70。
    • 更新的COVID-19疫苗的明确监管途径允许及时适应新的变异株,确保Moderna能够维持在不断变化的COVID-19市场中的地位70。
  • 挑战:
    • 未来监管环境的不确定性以及潜在更严格的审批标准可能会增加将新产品推向市场的风险和复杂性7。
    • 关键产品线候选药物(如CMV疫苗)面临FDA审查延迟或不批准的风险,这可能会严重影响Moderna的财务预测和增长前景。CMV疫苗早期疗效标准初步结果的挫折1突显了这一风险。
    • 不断变化的COVID-19疫苗推荐和加强针资格指南76可能会影响Moderna COVID-19疫苗的需求和销量。

股价分析与风险评估

当前股价与表现

截至2025年4月10日,Moderna的股价约为24.50美元95。这与其在2021年超过480美元的峰值相比显著下降6,反映了疫情后市场回调以及对未来增长的担忧。自2021年峰值以来,该股经历了显著的波动和下行趋势6。与更广泛的医疗保健行业(XLV)相比,该股的表现逊于大盘114,进一步凸显了投资者的担忧。

分析师评级和目标股价

分析师的普遍评级通常为“持有”或“中性”,目标股价范围广泛,表明对Moderna近期前景存在不确定性,但同时也认可其长期潜力4。平均目标股价显示出显著的上涨潜力(例如,TipRanks的平均目标股价为50.88美元134,Fintel为53.14美元130,纳斯达克为75.14美元119),但个人目标股价差异很大(例如,低至25美元,高至222.60美元130)。一些分析师因营收下降和市场竞争等担忧而下调了该股评级或目标股价115。摩根士丹利将其目标股价下调至32美元,评级为“持有”122,而摩根大通则将其评级下调至“减持”,目标股价为70美元115。

主要风险因素

  • 市场竞争: 在COVID-19疫苗市场面临来自辉瑞和诺瓦瓦克斯的激烈竞争,并且预计在RSV疫苗市场将面临来自GSK和辉瑞的竞争4。
  • 技术风险: 针对新变异株的COVID疫苗更新可能不成功或延迟141。
  • 监管风险: 监管环境的不确定性,潜在更严格的审批标准,以及主要产品线候选药物面临延迟或不批准的风险6。
  • 财务风险: 预计2025年营收下降,尽管削减成本但现金消耗巨大,以及可能需要进一步削减成本1。
  • 临床试验风险: 关键产品线候选药物(如CMV疫苗和个性化癌症疫苗)正在进行的临床试验可能延迟或失败1。
  • 公众认知风险: 对mRNA疫苗日益增长的怀疑以及潜在的限制性立法可能会影响公众的接受度和使用81。

未来前景与股票估值

增长机遇

2025年下一代COVID疫苗、RSV疫苗和流感/COVID联合疫苗的潜在批准和上市,为部分抵消Spikevax销售额的下降提供了近期收入催化剂1。个性化癌症疫苗(mRNA-4157)代表着一个重要的长期增长领域,其IIb期数据令人鼓舞,III期试验正在进行中,显示出黑色素瘤患者无复发生存期持续改善的潜力1。针对CMV和诺如病毒等潜伏病毒的疫苗开发解决了大量未满足的医疗需求,具有巨大的市场潜力,尽管CMV疫苗最近未能达到早期疗效标准1。丙酸血症(PA)和甲基丙二酸血症(MMA)等罕见病疗法为治疗选择有限的利基市场提供了机会,并有可能通过FDA START等项目加快开发1。政府为大流行性流感疫苗开发提供的资金和合作也为Moderna的mRNA技术提供了市场机遇142。

股票估值考量

当前股价反映了对COVID-19疫苗销量下滑以及产品线产生可观收入所需时间的担忧,这从其股价较峰值大幅下跌可以看出6。分析师的目标股价表明存在潜在的上涨空间,但这取决于产品线的成功开发和监管批准,一些分析师对近期财务不确定性表示谨慎58。相对于现金储备和潜在未来收入,较低的企业价值可能使Moderna成为寻求扩大其mRNA能力的大型制药公司的有吸引力的收购目标106。该股较高的空头兴趣在积极消息出现的情况下,也可能引发空头挤压,从而导致股价迅速上涨113。

结论与投资考量

Moderna公司正处于一个关键的转型时期。在经历了由COVID-19大流行推动的显著增长之后,公司现在面临着疫苗需求下降和向更广泛的mRNA产品线过渡的挑战。虽然近期财务前景面临营收大幅下滑和现金消耗的压力,但Moderna拥有一系列有前景的候选药物,涵盖了呼吸道疾病、罕见病、肿瘤和潜伏病毒等多个治疗领域。下一代COVID疫苗、RSV疫苗和流感/COVID联合疫苗的潜在批准,以及个性化癌症疫苗和CMV疫苗的持续进展,为未来的增长提供了重要的机会。

然而,Moderna的未来成功并非没有风险。公司在竞争激烈的疫苗市场中面临着激烈的竞争,尤其是在RSV疫苗领域。监管环境仍然存在不确定性,未来批准的延迟或失败可能会影响其增长轨迹。此外,公众对mRNA技术的看法以及潜在的限制性立法也可能构成挑战。从财务角度来看,营收的显著下降和持续的研发投资意味着Moderna在短期内仍将面临盈利压力。

当前Moderna的股价已较其历史高点大幅下跌,这在一定程度上反映了市场对COVID-19疫苗需求下降以及新产品上市时间的不确定性的担忧。分析师的评级普遍为“持有”,目标股价差异较大,这表明市场对该股的未来走向存在分歧。虽然一些分析师认为该股具有显著的上涨潜力,但其他人则对近期前景持谨慎态度。

综合来看,Moderna的未来前景充满机遇,但也面临着显著的风险。公司在mRNA技术领域的领先地位及其多元化的产品线为长期增长提供了坚实的基础。然而,投资者应密切关注关键产品候选药物的临床试验结果、监管部门的决策以及公司在竞争激烈的市场中成功实现商业化的能力。当前Moderna的股价似乎已经反映了其未来前景所面临的相当大的风险,但其能否充分反映潜在的增长机会,将取决于其产品线能否成功通过监管审批并获得市场认可。投资者在做出投资决定时,应仔细权衡这些风险和机遇。

关键表格

  1. Moderna的主要产品线候选药物
项目名称目标适应症试验阶段预期里程碑参考片段ID
mRNA-1283下一代COVID-19疫苗III期FDA批准 (2025年5月31日PDUFA)1
mRNA-1345 (mRESVIA)RSV疫苗 (成人60+)已批准sBLA获FDA批准 (2025年6月12日PDUFA)1
mRNA-1083流感/COVID联合疫苗 (成人50+)III期FDA批准1
mRNA-1647CMV疫苗 (育龄妇女)III期最终疗效数据 (2025年)1
mRNA-1403诺如病毒疫苗III期疗效数据 (2025年)1
mRNA-4157个体化新抗原疗法 (INT)III期持续招募1
mRNA-3927丙酸血症 (PA) 疗法II期注册试验数据生成1
mRNA-3705甲基丙二酸血症 (MMA) 疗法II期注册研究启动 (2025年上半年)1
  1. 近期与Moderna相关的FDA监管行动
法规/指南发布/批准日期与Moderna的相关性参考片段ID
更新的mRNA COVID-19疫苗 (2024-2025配方)2024年8月22日批准和EUA70
下一代COVID-19疫苗 (mRNA-1283) BLA受理未提及具体日期潜在批准 (PDUFA 2025年5月31日)1
高风险成人RSV疫苗 (mRNA-1345) sBLA受理未提及具体日期潜在批准 (PDUFA 2025年6月12日)1
赛诺菲流感/COVID-19联合疫苗快速通道资格2024年12月11日竞争格局77
加速批准指南草案2024年12月6日/2025年1月7日审批途径78
  1. Moderna股票分析师评级和目标股价
分析师机构评级日期评级目标股价 (美元)参考片段ID
摩根士丹利2025年4月9日持有32122
RBC Capital2025年4月3日持有32122
伯恩斯坦2025年4月2日持有未提及122
布鲁克林资本市场2025年3月31日持有未提及122
花旗2025年3月26日中性未提及122
摩根大通2025年3月21日减持70122
瑞银2025年2月19日买入未提及122
巴克莱2025年2月18日持有 (降级)45 (原为111)122
美国银行证券2025年2月11日卖出32 (原为34)122
高盛2025年2月14日持有 (降级)51 (原为99)122
Wolfe Research2025年2月14日卖出25 (原为35)122
Needham2025年2月14日持有未提及122
  1. Moderna的主要风险与机遇
风险/机遇因素描述参考片段ID
市场竞争COVID-19和RSV疫苗市场竞争激烈4
技术风险COVID疫苗更新可能延迟或失败141
监管风险监管环境不确定,审批可能延迟6
财务风险2025年营收预计下降,现金消耗大1
临床试验风险关键候选药物试验可能延迟或失败1
公众认知风险对mRNA疫苗的疑虑可能影响接种率81
增长机遇2025年潜在产品批准上市1
增长机遇个性化癌症疫苗的长期潜力1
增长机遇CMV和诺如病毒疫苗的市场潜力1
增长机遇罕见病疗法的市场机会1
增长机遇政府对流感疫苗研发的支持142
股票估值低企业价值可能吸引收购106
股票估值高空头兴趣可能引发轧空113

引用的著作

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  72. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants - GovDelivery, 访问时间为 四月 11, 2025, https://content.govdelivery.com/accounts/USFDA/bulletins/3717442
  73. FDA Approves and Authorizes 2024-2025 COVID-19 Vaccines, 访问时间为 四月 11, 2025, https://immunizedelaware.org/fda-approves-and-authorizes-2024-2025-covid-19-vaccines/
  74. Updated 2024–2025 mRNA COVID-19 Vaccines Approved and Granted EUA by FDA, 访问时间为 四月 11, 2025, https://www.biopharminternational.com/view/updated-2024-2025-mrna-covid-19-vaccines-approved-granted-eua-fda
  75. FDA Approves, Grants EUA for Updated 2024–2025 mRNA COVID-19 Vaccines, 访问时间为 四月 11, 2025, https://www.pharmtech.com/view/fda-approves-grants-eua-updated-2024-2025-mrna-covid-19-vaccines
  76. Clinical Guidance for COVID-19 Vaccination - CDC, 访问时间为 四月 11, 2025, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html
  77. Press Release: Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track designation in the US - Sanofi, 访问时间为 四月 11, 2025, https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-11-06-00-00-2995072
  78. Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies - McGuireWoods, 访问时间为 四月 11, 2025, https://www.mcguirewoods.com/client-resources/alerts/2025/1/rethinking-fdas-accelerated-approval-pathway-new-draft-guidances-and-implications-for-drug-companies/
  79. New Accelerated Approval Guidance Underscores Need for Accountability, 访问时间为 四月 11, 2025, https://www.fdalawblog.com/2024/12/articles/fda/new-accelerated-approval-guidance-underscores-need-for-accountability/
  80. Drug Promotion, Nonprescription Pathways, and Advanced Manufacturing: FDA’s Key Focus Areas in 2024 and What’s Next for 2025 - GeneOnline, 访问时间为 四月 11, 2025, https://www.geneonline.com/fdas-key-focus-areas-in-2024-and-whats-next-for-2025/
  81. MRNA Vaccines, Once a Trump Boast, Now Face Attacks From Some in GOP, 访问时间为 四月 11, 2025, https://kffhealthnews.org/news/article/mrna-vaccines-trump-boast-under-gop-attacks-legislation/
  82. Moderna COVID-19 Vaccine - FDA, 访问时间为 四月 11, 2025, https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine
  83. Development of mRNA Vaccines: Scientific and Regulatory Issues - PMC, 访问时间为 四月 11, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC7910833/
  84. FDA’s accelerated approval guidance gets pushback from industry - RAPS, 访问时间为 四月 11, 2025, https://www.raps.org/news-and-articles/news-articles/2025/3/fda-s-accelerated-approval-guidance-gets-pushback
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  86. Influenza Vaccine Market Size & ShareIndustry Growth, 2032 - Fortune Business Insights, 访问时间为 四月 11, 2025, https://www.fortunebusinessinsights.com/industry-reports/influenza-vaccine-market-101896
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  89. Mrna Flu Vaccine Market Size, Share & Industry Trends By 2032, 访问时间为 四月 11, 2025, https://www.databridgemarketresearch.com/reports/global-mrna-flu-vaccine-market
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  91. Influenza Drugs And Vaccines Market Size, Share & Forecast - Verified Market Research, 访问时间为 四月 11, 2025, https://www.verifiedmarketresearch.com/product/influenza-drugs-and-vaccines-market/
  92. Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts, 访问时间为 四月 11, 2025, https://www.skadden.com/insights/publications/2025/02/under-rfk-jr-us-health-policy-and-fda-operations-may-see-major-shifts
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  98. Moderna Inc (MRNA) Stock Price, News & Analyst Forecast - eToro, 访问时间为 四月 11, 2025, https://www.etoro.com/markets/mrna
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