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2021-11-26
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Novavax: Some Burning Questions<blockquote>Novavax：一些紧迫的问题</blockquote>
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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":877372817,"tweetId":"877372817","gmtCreate":1637892995065,"gmtModify":1637892995330,"author":{"id":3577349862351641,"idStr":"3577349862351641","authorId":3577349862351641,"authorIdStr":"3577349862351641","name":"RachelNg","avatar":"https://static.tigerbbs.com/c686e5f51b908bf5b83c479fe9153fb1","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"wearingBadges":[],"fanSize":34,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"title":"","extraTitle":"","html":"<html><head></head><body><p>O</p></body></html>","htmlText":"<html><head></head><body><p>O</p></body></html>","text":"O","highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":3,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/877372817","repostId":1172101126,"repostType":4,"repost":{"id":"1172101126","kind":"news","pubTimestamp":1637892884,"share":"https://www.laohunote.com/m/news/1172101126?lang=zh_CN&edition=full","pubTime":"2021-11-26 10:14","market":"us","language":"en","title":"Novavax: Some Burning Questions<blockquote>Novavax：一些紧迫的问题</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1172101126","media":"Seeking Alpha","summary":"Summary\n\nNovavax is making good progress with SII backed regulatory filings.\nSII and the Indian gove","content":"<p><b>Summary</b></p><p><blockquote><b>总结</b></blockquote></p><p> <ul> <li>Novavax is making good progress with SII backed regulatory filings.</li> <li>SII and the Indian government “ban” on COVID vaccine exports are a necessary vulnerability in the short term.</li> <li>Investors cannot have tunnel vision on SII and Novavax must urgently provide answers on manufacturing, stockpiles, and shipments.</li> </ul> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/2494454304cd81dfbde9de88defac732\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\"><span>Maria Golenishcheva/iStock via Getty Images</span></p><p><blockquote><ul><li>Novavax 在 SII 支持的监管备案方面取得了良好进展。</li><li>SII 和印度政府对 COVID 疫苗出口的 “禁令 ”是短期内必要的漏洞。</li><li>投资者不能对 SII 抱有狭隘的看法，Novavax 必须紧急提供有关制造、库存和运输的答案。</li></ul><p class=\"t-img-caption\"><span>Maria Golenishcheva/iStock via Getty Images</span></p></blockquote></p><p> Novavax(NASDAQ:NVAX)has announced its intention to participate in a Fireside Chat at Evercore ISI's 4th Annual HealthCONx Virtual Conference on 2 December 2021. This is the first event at which Novavax will participate since the Earnings Call(EC)on 4 November 2021.BioNTech(NASDAQ:BNTX) has participated in 3 events since their EC on 9 Nov including the Jefferies London Healthcare Conference and will also participate in the Evercore event.Moderna(NASDAQ:MRNA) also has participated in 3 events since their EC on 4 Nov and have announced participation in two more before 2 Dec but has not yet advised if they will be attending Evercore. Participating at events provide investors with general information. Novavax's absence form events in November has left a lot of questions unanswered.</p><p><blockquote>Novavax（纳斯达克股票代码：NVAX）宣布打算参加 2021 年 12 月 2 日举行的 Evercore ISI 第四届年度 HealthCONx 虚拟会议的炉边聊天。这是 Novavax 自 2021 年 11 月 4 日财报看涨期权 (EC) 以来参加的首次活动。 BioNTech（纳斯达克股票代码：BNTX）自 11 月 9 日董事会以来已参加了 3 场活动，包括 Jefferies London Healthcare 会议，还将参加 Evercore 活动。 Moderna（纳斯达克股票代码：MRNA）自 11 月 4 日董事会以来也参加了 3 场活动，并在 12 月 2 日之前宣布参加另外两场活动，但尚未告知他们是否会参加 Evercore。参与活动为投资者提供一般信息。Novavax 缺席 11 月份的活动，导致许多问题仍未得到解答。</blockquote></p><p> Novavax has announced the following successes since the EC:</p><p><blockquote>Novavax 宣布了自 EC 以来取得的以下成功：</blockquote></p><p> <ul> <li>Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373.</li> <li>Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines.</li> <li>Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization.</li> <li>Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore.</li> </ul> The Novavax progress continues but at the same time the vacuum of information on manufacturing and delivery remains. It is important to discuss the burning questions and the lack of information on manufacturing, stockpile, and delivery.</p><p><blockquote><ul><li>在韩国提交批准NVX-CoV2373的生物制剂许可证申请。</li><li>Novavax和印度血清研究所获得菲律宾新冠肺炎疫苗的紧急使用授权。</li><li>Novavax 确认欧洲药品管理局对 COVID-19 疫苗申请有条件上市授权的审查。</li><li>Novavax 在新加坡申请 COVID-19 疫苗临时授权。</li></ul>Novavax 的进步仍在继续，但与此同时，有关制造和交付的信息仍然存在真空。讨论紧迫的问题以及制造、库存和交付信息的缺乏是很重要的。</blockquote></p><p> None of the recent notices made specific reference to manufacturing or delivery. The notice on the Philippines is not clear on whether SII will be delivering vaccine doses to the Philippines at all or whether SII must first construct a manufacturing facility in the Philippines from which vaccines will be delivered. The statement reads, “The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™.” Why this wording “manufactured and marketed in the Philippines”? Was it just clumsy or not? The Philippines announced an intention in March 2021 to partner with SII for manufacturing in the Philippines.</p><p><blockquote>最近的通知均未具体提及制造或交付。关于菲律宾的通知没有明确说明SII是否会向菲律宾交付疫苗剂量，或者SII是否必须首先在菲律宾建造一个生产设施，从那里交付疫苗。声明中写道：“该疫苗将由 SII 在菲律宾生产和销售，品牌名为 COVOVAX”。™为什么是“在菲律宾制造和销售”的措辞？只是笨拙还是不笨拙？菲律宾于2021年3月宣布有意与SII合作在菲律宾进行制造。</blockquote></p><p> “PH eyes local vaccine production with Serum Institute of India” March 17, 2021. India has a general “restriction” on the export of COVID vaccines from India. It’s an unofficial “ban” on exports which are only allowed with government of India approval. It is also disconcerting that the application for approval of the Novavax vaccine has been submitted to India already on 5 August 2021 and it has not yet been approved by India.</p><p><blockquote>“PH 着眼于与印度血清研究所合作进行本地疫苗生产”，2021 年 3 月 17 日。印度对印度出口 COVID 疫苗有普遍 “限制”。这是一项非官方的 “禁令”，只有在印度政府批准的情况下才允许出口。同样令人不安的是，Novavax疫苗的批准申请已于2021年8月5日提交给印度，但尚未获得印度的批准。</blockquote></p><p> “He, however, clarified there was no ban on vaccine exports as neither the health ministry, commerce and industry ministry, department of promotion of industry and internal trade, nor the directorate general of foreign trade has issued any formal orders asking to bar the export of COVID-19 vaccines from the country.”COVID vaccines’ export may not resume before 2022. Digging in news reports on deliveries to Indonesia indicate delivery of 20mil doses by the end of Dec 2021.Reuters reported on 18 November that, “India allows export of 20 mln Novavax vaccine doses to Indonesia -document, source”.Shipment is likely to happen towards the end of next month, one of the sources said. Further reporting has SII potentially producing up to 100mil doses by the end of Dec 2021.</p><p><blockquote>“不过，他澄清说，没有禁止疫苗出口，因为卫生部、商业和工业部、工业促进和国内贸易部以及对外贸易总局都没有发布任何正式命令，要求禁止从该国出口 COVID-19 疫苗。COVID 疫苗的出口可能在 2022 年之前不会恢复。挖掘有关向印度尼西亚交付的新闻报道显示，到2021年12月底，将交付2000万剂疫苗。路透社11月18日报道称，“印度允许向印度尼西亚出口2000万剂诺瓦瓦克斯疫苗——文件，消息来源”。其中一位消息人士称，发货可能会在下月底左右进行。进一步报道称，到2021年12月底，SII有可能生产多达1亿剂。</blockquote></p><p> The very bullish investment thesis for Novavax is still intact but investors cannot be expected to have tunnel vision on SII. Investors need quality communication from Novavax to maintain that investment thesis. The vacuum of information on the big picture for manufacturing, stockpiles, shipments, revenue, and income encourages wild speculation and rumor mongering.</p><p><blockquote>Novavax 非常乐观的投资论点仍然完好无损，但不能指望投资者对 SII 抱有狭隘的看法。投资者需要 Novavax 的高质量沟通来维持这一投资论点。关于制造、库存、运输、收入和收入的大局信息真空鼓励了疯狂的投机和谣言传播。</blockquote></p><p> <b>Burning Questions around Manufacturing, Stockpile and Shipments.</b></p><p><blockquote><b>围绕制造、库存和运输的紧迫问题。</b></blockquote></p><p></p><p> No amount of digging could provide substantiated answers to the following questions which are vital for investors to make informed decisions on investing in Novavax shares. Investors are forced to infer or speculate on the answers to many of these questions in the absence of facts. Perhaps some of these questions will be answered in the Fireside Chat with Evercore. Perhaps Novavax will become more forthcoming about its activities, but investors are desperate for reliable information. Most companies go out of their way to sit down with analysts and give them quality information empowering them to achieve the same outcomes as the guidance of the company. Novavax has been skirting the questions around manufacturing, stockpiles and shipments and it has become pressing for investors to have reliable information.</p><p><blockquote>再多的挖掘也无法为以下问题提供确凿的答案，这些问题对于投资者在投资 Novavax 股票时做出明智的决定至关重要。在缺乏事实的情况下，投资者被迫推断或推测其中许多问题的答案。也许其中一些问题会在与Evercore的炉边聊天中得到解答。也许 Novavax 会对其活动更加坦诚，但投资者迫切需要可靠的信息。大多数公司都会不遗余力地与分析师坐下来，为他们提供高质量的信息，使他们能够实现与公司指导相同的结果。Novavax 一直回避有关制造、库存和运输的问题，投资者迫切需要获得可靠的信息。</blockquote></p><p> The questions which follows can't be answered from available information. Investors are at risk in the absence of the information which should be readily available to be packaged for investors. Each question will be followed by an explanation why the information is important.</p><p><blockquote>以下问题无法从现有信息中回答。由于缺乏本应随时为投资者打包的信息，投资者面临风险。每个问题之后都会解释为什么这些信息很重要。</blockquote></p><p> <b>Manufacturing Questions</b></p><p><blockquote><b>制造问题</b></blockquote></p><p></p><p> <ol> <li>Why has no other manufacturing facility, particularly the Novavax specific facilities, been submitted yet? Importance: Novavax was following a holistic approach towards achieving regulatory approval for all its manufacturing facilities up to the point when the Politico article was published on 19 October 2021. \"...we’ve built a global manufacturing infrastructure over the last year that has a robust eight different antigen manufacturing facilities in seven different countries.\" On 27 October 2021 Novavax filed for authorization of its vaccine in the UK and that filing was narrowed from a \"global manufacturing infrastructure\" to a single manufacturer filing that \"leverages our manufacturing partnership with the Serum Institute of India.In the near future, we expect to supplement this filing with supply from our global supply chain.\" All subsequent regulatory filings since 27 October 2021, other than South Korea were done in the same manner, leveraging SII as manufacturer.</li> <li>Will all facilities now manufacture components and export them to SII for manufacturing or fill & finish? Importance: Stanley Erck, CEO of Novavax said at the EC: \"And so they (SII) have fill finish capacity that's virtually unlimited. We can make many hundreds of millions of doses per month in their facility. And we've also signed an agreement with them, if we want for them to make product for high income markets. And so we have a CDMO agreement with them. And so they wouldn't supply as finished product, whether in one of two ways either from antigen, these spike protein that they make at Serum, or from spike protein that we make in our various sites around the world.\" The shift to SII seems to also imply greater reliance on the manufacturing capabilities of SII. It is important for investors to understand the implications of this shift.</li> <li>Can SII export any vaccine doses without approvals from the Indian government? Importance: As indicated above, exports of COVID vaccines from India are presently subject to, at the very least, Indian government approvals. The shift towards utilizing SII manufacturing facilities requires understanding of the potential risk associated with reliance on a single manufacturer and single country.</li> <li>SII reported communication on manufacturing is materially more conservative than Novavax reports, indicating only up to 100mil doses manufactured by the end of Dec 2021. Why the difference? Importance: John Trizzino said at the EC: \"Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter.\" SII as quoted above expect to produce up to 100mil doses by the end of Dec 2021. The discrepancy between Novavax and SII is, between 150mil doses per month vs up to 100mil doses by the end of Dec 2021.</li> <li>How much actual manufacturing of regulatory compliant vaccine doses are taking place at Novavax manufacturing facilities and all partner facilities? Not capacity, actual manufacturing. Importance: Novavax describes manufacturing as \"manufacturing capacity\" (see 4 above). SII indicated production of up to 100mil doses by the end of Dec 2021 and presently is the only manufacturer put forward in regulatory filings. Investors need information on the activities of the other manufacturers in the global manufacturing network to support the investment thesis particularly looking at 2022 and beyond. How and when would they start contributing to actual doses being available for deliveries?</li> <li>When will all other manufacturing facilities be submitted for regulatory approvals? Importance: All other manufacturing facilities were supposed to have been included in the \"near future\" which is ambiguous. It's one month later and no guidance or filings have been made for any of these facilities.</li> <li>What is the manufacturing guidance from all facilities say by Q1, Q2, Q3 and full year? Not capacity guidance, actual manufactured doses, regulatory compliant and available for shipment and delivery. Importance: This question follows from 6 above and the guidance is needed to estimate the revenue and income potential for Novavax during those periods. Novavax provided no guidance on full year 2021 or 2022 earnings during the EC.</li> <li>Investors will need information on manufacturing at the different facilities to allow for reasoned estimates of sales into different regions as well as COVAX. What will be the composition of manufacturing and delivery for low value sales and for high value sales? Importance: Novavax's reported sales prices range from $3 per dose to $21. The allocations of manufactured doses from the various manufacturing facilities are important indicators of the potential revenue which can be expected from those deliveries. It is expected that a material portion of the SII manufacturing will initially go to COVAX and into markets where </p><p><blockquote><ol><li>为什么还没有提交其他制造设施，特别是Novavax特定设施？重要性：在 2021 年 10 月 19 日发表 Politico 文章之前，Novavax 一直在遵循整体方法来获得其所有制造设施的监管部门批准。“......在过去的一年里，我们建立了一个全球制造基础设施，在七个不同的国家拥有八个不同的抗原制造设施。”2021 年 10 月 27 日，Novavax 在英国申请其疫苗授权，该申请范围从“全球制造基础设施”缩小到“利用我们与印度血清研究所的制造合作伙伴关系”的单一制造商申请。在不久的将来，我们希望通过来自我们全球供应链的供应来补充这份申请。”自2021年10月27日起，除韩国外，所有后续监管备案均以相同方式完成，利用SII作为制造商。</li><li>所有工厂现在都会制造零部件并出口到 SII 进行制造或灌装和精加工吗？重要性：Novavax 首席执行官 Stanley Erck 在 EC 上表示：“因此，他们（SII）拥有几乎无限的灌装产能。我们每月可以在他们的工厂生产数亿剂疫苗。如果我们希望他们为高收入市场生产产品，我们还与他们签署了一项协议。因此，我们与他们签订了 CDMO 协议。因此，他们不会以两种方式之一提供成品，要么来自抗原（他们在血清中制造的刺突蛋白），要么来自我们在世界各地各个地点制造的刺突蛋白。”向SII的转变似乎也意味着对SII制造能力的更大依赖。对于投资者来说，了解这种转变的影响非常重要。</li><li>未经印度政府批准，SII可以出口任何疫苗剂量吗？重要性：如上所述，印度出口的COVID疫苗目前至少要经过印度政府的批准。向利用SII制造设施的转变需要了解与依赖单一制造商和单一国家相关的潜在风险。</li><li>SII 报告的制造沟通比 Novavax 报告的要保守得多，表明截至 2021 年 12 月底，仅生产了多达 1 亿剂疫苗。为什么会有区别？重要性：John Trizzino 在 EC 上表示：“展望未来几个月，我们预计到第四季度末将实现每月 1.5 亿剂的产能。”上面引用的SII预计到2021年12月底将生产多达1亿剂。Novavax和SII之间的差异是，到2021年12月底，每月1.5亿剂剂量高达1亿剂。</li><li>Novavax生产设施和所有合作伙伴设施实际生产了多少符合法规的疫苗剂量？不是产能，而是实际制造。重要性：Novavax将制造描述为“制造能力”（见上文4）。SII 表示，到 2021 年 12 月底，产量将达到 1 亿剂，目前是唯一一家在监管文件中提出的制造商。投资者需要有关全球制造网络中其他制造商活动的信息，以支持投资论点，特别是着眼于 2022 年及以后。他们将如何以及何时开始为实际分娩剂量做出贡献？</li><li>所有其他制造设施何时提交监管部门批准？重要性：所有其他制造设施都应该包括在“不久的将来”中，这是模棱两可的。一个月过去了，这些设施都没有得到指导或备案。</li><li>第一季度、第二季度、第三季度和全年所有工厂的制造指导是什么？无容量指南、实际生产剂量、符合法规并可用于装运和交付。重要性：这个问题源于上述6点，需要指导来估计Novavax在这些时期的收入和收入潜力。Novavax 在 EC 期间没有提供 2021 年或 2022 年全年收益指导。</li><li>投资者将需要有关不同工厂生产的信息，以便对不同地区以及 COVAX 的销售额进行合理估计。低价值销售和高价值销售的制造和交付构成是什么？重要性：Novavax 报告的销售价格从每剂 3 美元到 21 美元不等。来自各个制造设施的制造剂量的分配是可以预期从这些交付中获得的潜在收入的重要指标。预计 SII 制造的很大一部分最初将流向 COVAX 并进入以下市场</li></ol></blockquote></p><p></p><p> <ol> <li>What is the size of the actual stockpile at SII, tens of millions can be 20mil doses or up to 90mil doses, it is far too inexact? Importance: The Novavax CEO answered at the EC: \"Well, I think I answered the second part of the question that SII will be the initial manufacturer. They've already made many 10s of millions of doses that are waiting to be shippable. They're sitting we've -- my team has physically gone over there and touched them.\" The stockpile can theoretically be shipped with immediate effect and generate income still in 2021. The actual size matters.</li> <li>What is the size of the regulatory compliant stockpile of doses at all facilities combined, again, tens of millions are not exact enough? Importance: The communication at the EC was very fragmented but it seems that there may be inventory other than that at SII. Novavax CEO: \"And for each of these, we're trying to allocate product both that we have in inventory in the U.S. and Europe and South Korea and an inventory that's being built up at Serum...\" Better understanding of regulatory compliant available inventory at all facilities will inform investor expectations on the timing of revenue as well as the expected quantum thereof.</li> <li>What is the breakdown of the stockpile at the various manufacturing facilities, those able to deliver a finished product? Importance: A breakdown of the stockpile will guide investor expectations regarding potential income from high value deliveries vs low value deliveries and the timing thereof.</li> <li>There has been rumor that the 20mil dose export from SII was approved because of its expiry date, rumor is not where information should originate from. How dated is the various stockpiles?</li> </ol> <b>Shipment and Delivery Questions</b></p><p><blockquote><ol><li>SII的实际库存是多少，几千万可以是2000万剂，也可以是9000万剂，这太不准确了？重要性：Novavax 首席执行官在 EC 上回答道：“嗯，我想我回答了问题的第二部分，即 SII 将成为最初的制造商。他们已经生产了数千万剂等待发货。他们坐在那里我们已经——我的团队已经亲自去那里触摸了他们。”理论上，该库存可以立即发货，并在2021年仍然产生收入。实际尺寸很重要。</li><li>所有设施的合规剂量库存总和是多少，同样，数千万是不够准确的？重要性：欧共体的沟通非常分散，但似乎除了SII之外，可能还有其他库存。Novavax 首席执行官：“对于每一个产品，我们都在尝试分配我们在美国、欧洲和韩国库存中的产品以及 Serum 正在建立的库存……”更好地了解所有设施的合规可用库存将为投资者对收入时间及其预期数量的预期提供信息。</li><li>能够交付成品的各种制造工厂的库存明细是什么？重要性：库存明细将指导投资者对高价值交付与低价值交付的潜在收入及其时机的预期。</li><li>有传言称，从SII出口的2000万剂量是因为其有效期而被批准的，谣言不是信息应该来自哪里。各种库存有多久远？</li></ol><b>运输和交付问题</b></blockquote></p><p> <ol> <li>Why will the 20mil shipment to Indonesia only take place by the end of Dec 2021 if the doses are available in stockpile right now? Importance: Novavax CEO at the EC: \"We've expect that initial shipments into Indonesia by Serum will begin imminently.\" The guidance of SII on delivery to Indonesia clearly differs from the comment by the CEO of Novavax. This question also has a larger context. How many doses can be expected to be shipped still in 2021 which will translate into revenue and income for the full year results EC in March 2022?</li> <li>Why only 20mil doses? Importance: SII has tens of millions of doses in stockpile and can manufacture up to 100mil doses be the end of Dec 2021 yet only 20mil doses out of a 50mil doses order by Indonesia are expected to be shipped by end of Dec 2021.</li> <li>How many doses are SII expected to ship in 2021? Importance: This question follows on q2 above. There are potential doses for shipment from stockpile and from manufacturing yet only 20mil has been reported.</li> <li>Where will doses be shipped from in 2022, which manufacturing facilities? Importance: The shift in emphasis to SII for the time being raises this question. Which of the other manufacturing facilities in the global manufacturing network will be designated to ship finished product?</li> <li>How many doses are expected be shipped and delivered in H1 and full year in 2022. Importance: All of the Novavax guidance is \"manufacturing capacity\" which informs investors what the maximum potential production capacity may be, but it does not inform the investor how much actual manufacturing can be expected within a given period, manufactured product which can be delivered under sales agreements.</li> <li>Why are no shipments to the Philippines scheduled so far? Importance: A tiny shipment of 20mil doses has been reported for Indonesia but no scheduled delivery to the Philippines has been reported so far.</li> </ol> Filing for regulatory approvals in the name of SII as manufacturer surely advances the standing of the Novavax vaccine but it needs to be backed up by manufacturing and an ability to export the vaccines to those countries who had purchased doses. The presence of the Indian government looms large in the manufacturing and shipments of doses from SII. This vulnerability of Novavax to a single supplier/manufacturer must be explored and understood. Yes, the other facilities will in time also contribute, but guidance so far has been that those facilities should have been in play already and they are not. Investors need to understand, why not? When will those facilities contribute regulatory approved doses and contribute to the revenue and income of Novavax?</p><p><blockquote><ol><li>如果现在有库存，为什么2000万剂运往印度尼西亚要到2021年12月底才会发货？重要性：Novavax 欧盟委员会首席执行官：“我们预计血清将很快开始向印度尼西亚发货。”SII 关于向印度尼西亚交付的指导显然与 Novavax 首席执行官的评论不同。这个问题还有一个更大的背景。预计2021年仍有多少剂量可以运输，这将转化为2022年3月EC全年业绩的收入和收益？</li><li>为什么只有2000万剂？重要性：SII有数千万剂库存，到2021年12月底可以生产多达1亿剂，但印度尼西亚5000万剂订单中只有2000万剂预计到2021年12月底发货。</li><li>SII预计在2021年出货多少剂？重要性：这个问题出现在上面的第二季度。有从库存和生产中发货的潜在剂量，但据报道只有2000万剂。</li><li>2022年，剂量将从哪里运送，哪些制造工厂？重要性：目前重点转移到SII提出了这个问题。全球制造网络中的哪些其他制造设施将被指定用于运输成品？</li><li>预计2022年上半年和全年将发货和交付多少剂。重要性：Novavax 的所有指南都是“生产能力”，它告知投资者最大潜在生产能力可能是多少，但它没有告知投资者在给定时期内可以预期实际生产量，即可以根据销售协议交付的制成品。</li><li>为什么到目前为止还没有安排向菲律宾发货？重要性：据报道，印度尼西亚有2000万剂疫苗的少量运输，但到目前为止，还没有向菲律宾交付的计划。</li></ol>以 SII 作为制造商的名义申请监管部门批准无疑会提高 Novavax 疫苗的地位，但它需要得到制造和向已购买疫苗的国家出口疫苗的能力的支持。印度政府在SII疫苗的制造和运输中起着重要作用。必须探索和理解Novavax对单一供应商/制造商的这种脆弱性。是的，其他设施也将及时做出贡献，但到目前为止，指导是这些设施应该已经投入使用，但它们没有。投资者需要明白，为什么不呢？这些设施何时会提供监管批准的剂量并为 Novavax 的收入和收益做出贡献？</blockquote></p><p> <b>Conclusion</b></p><p><blockquote><b>结论</b></blockquote></p><p></p><p> Novavax has made good progress since the Politico article to prove its ability to manufacture and deliver vaccine doses. Concentrating all the filings and all the manufacturing at SII are exposing Novavax to a single source manufacturer/supplier and political risk. The absence of information on manufacturing, stockpiles and shipments have become burning questions for investors. 2021 is almost over and only one shipment for 20mil vaccine doses is scheduled for the end of Dec 2021. It is hoped that Novavax will initiate a process to provide quality information on the burning questions around manufacturing, stockpiles and shipments and perhaps deal with some of it at the Evercore Fireside Chat. Investors require quality information to inform their decisions to buy Novavax shares and hold them based upon an informed investment thesis. The information currently available is lacking in that regard given a significant strategic shift by Novavax since the publication of the Politico article.</p><p><blockquote>自Politico文章以来，Novavax在证明其制造和交付疫苗剂量的能力方面取得了良好进展。将所有备案和所有制造集中在SII，使Novavax面临单一来源制造商/供应商和政治风险。缺乏制造、库存和发货信息已成为投资者亟待解决的问题。2021 年即将结束，只有一批 2000 万剂疫苗计划于 2021 年 12 月底发货。希望 Novavax 能够启动一个流程，提供有关制造、库存和运输等紧迫问题的质量信息，并可能在 Evercore 炉边聊天中处理其中的一些问题。投资者需要高质量的信息来为他们购买 Novavax 股票的决定提供信息，并根据明智的投资论点持有这些股票。鉴于自 Politico 文章发表以来 Novavax 发生了重大战略转变，目前可获得的信息在这方面缺乏。</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Novavax: Some Burning Questions<blockquote>Novavax：一些紧迫的问题</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax: Some Burning Questions<blockquote>Novavax：一些紧迫的问题</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Seeking Alpha</strong><span class=\"h-time small\">2021-11-26 10:14</span>\n</p>\n</h4>\n</header>\n<article>\n<p><b>Summary</b></p><p><blockquote><b>总结</b></blockquote></p><p> <ul> <li>Novavax is making good progress with SII backed regulatory filings.</li> <li>SII and the Indian government “ban” on COVID vaccine exports are a necessary vulnerability in the short term.</li> <li>Investors cannot have tunnel vision on SII and Novavax must urgently provide answers on manufacturing, stockpiles, and shipments.</li> </ul> <p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/2494454304cd81dfbde9de88defac732\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\"><span>Maria Golenishcheva/iStock via Getty Images</span></p><p><blockquote><ul><li>Novavax 在 SII 支持的监管备案方面取得了良好进展。</li><li>SII 和印度政府对 COVID 疫苗出口的 “禁令 ”是短期内必要的漏洞。</li><li>投资者不能对 SII 抱有狭隘的看法，Novavax 必须紧急提供有关制造、库存和运输的答案。</li></ul><p class=\"t-img-caption\"><span>Maria Golenishcheva/iStock via Getty Images</span></p></blockquote></p><p> Novavax(NASDAQ:NVAX)has announced its intention to participate in a Fireside Chat at Evercore ISI's 4th Annual HealthCONx Virtual Conference on 2 December 2021. This is the first event at which Novavax will participate since the Earnings Call(EC)on 4 November 2021.BioNTech(NASDAQ:BNTX) has participated in 3 events since their EC on 9 Nov including the Jefferies London Healthcare Conference and will also participate in the Evercore event.Moderna(NASDAQ:MRNA) also has participated in 3 events since their EC on 4 Nov and have announced participation in two more before 2 Dec but has not yet advised if they will be attending Evercore. Participating at events provide investors with general information. Novavax's absence form events in November has left a lot of questions unanswered.</p><p><blockquote>Novavax（纳斯达克股票代码：NVAX）宣布打算参加 2021 年 12 月 2 日举行的 Evercore ISI 第四届年度 HealthCONx 虚拟会议的炉边聊天。这是 Novavax 自 2021 年 11 月 4 日财报看涨期权 (EC) 以来参加的首次活动。 BioNTech（纳斯达克股票代码：BNTX）自 11 月 9 日董事会以来已参加了 3 场活动，包括 Jefferies London Healthcare 会议，还将参加 Evercore 活动。 Moderna（纳斯达克股票代码：MRNA）自 11 月 4 日董事会以来也参加了 3 场活动，并在 12 月 2 日之前宣布参加另外两场活动，但尚未告知他们是否会参加 Evercore。参与活动为投资者提供一般信息。Novavax 缺席 11 月份的活动，导致许多问题仍未得到解答。</blockquote></p><p> Novavax has announced the following successes since the EC:</p><p><blockquote>Novavax 宣布了自 EC 以来取得的以下成功：</blockquote></p><p> <ul> <li>Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373.</li> <li>Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines.</li> <li>Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization.</li> <li>Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore.</li> </ul> The Novavax progress continues but at the same time the vacuum of information on manufacturing and delivery remains. It is important to discuss the burning questions and the lack of information on manufacturing, stockpile, and delivery.</p><p><blockquote><ul><li>在韩国提交批准NVX-CoV2373的生物制剂许可证申请。</li><li>Novavax和印度血清研究所获得菲律宾新冠肺炎疫苗的紧急使用授权。</li><li>Novavax 确认欧洲药品管理局对 COVID-19 疫苗申请有条件上市授权的审查。</li><li>Novavax 在新加坡申请 COVID-19 疫苗临时授权。</li></ul>Novavax 的进步仍在继续，但与此同时，有关制造和交付的信息仍然存在真空。讨论紧迫的问题以及制造、库存和交付信息的缺乏是很重要的。</blockquote></p><p> None of the recent notices made specific reference to manufacturing or delivery. The notice on the Philippines is not clear on whether SII will be delivering vaccine doses to the Philippines at all or whether SII must first construct a manufacturing facility in the Philippines from which vaccines will be delivered. The statement reads, “The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™.” Why this wording “manufactured and marketed in the Philippines”? Was it just clumsy or not? The Philippines announced an intention in March 2021 to partner with SII for manufacturing in the Philippines.</p><p><blockquote>最近的通知均未具体提及制造或交付。关于菲律宾的通知没有明确说明SII是否会向菲律宾交付疫苗剂量，或者SII是否必须首先在菲律宾建造一个生产设施，从那里交付疫苗。声明中写道：“该疫苗将由 SII 在菲律宾生产和销售，品牌名为 COVOVAX”。™为什么是“在菲律宾制造和销售”的措辞？只是笨拙还是不笨拙？菲律宾于2021年3月宣布有意与SII合作在菲律宾进行制造。</blockquote></p><p> “PH eyes local vaccine production with Serum Institute of India” March 17, 2021. India has a general “restriction” on the export of COVID vaccines from India. It’s an unofficial “ban” on exports which are only allowed with government of India approval. It is also disconcerting that the application for approval of the Novavax vaccine has been submitted to India already on 5 August 2021 and it has not yet been approved by India.</p><p><blockquote>“PH 着眼于与印度血清研究所合作进行本地疫苗生产”，2021 年 3 月 17 日。印度对印度出口 COVID 疫苗有普遍 “限制”。这是一项非官方的 “禁令”，只有在印度政府批准的情况下才允许出口。同样令人不安的是，Novavax疫苗的批准申请已于2021年8月5日提交给印度，但尚未获得印度的批准。</blockquote></p><p> “He, however, clarified there was no ban on vaccine exports as neither the health ministry, commerce and industry ministry, department of promotion of industry and internal trade, nor the directorate general of foreign trade has issued any formal orders asking to bar the export of COVID-19 vaccines from the country.”COVID vaccines’ export may not resume before 2022. Digging in news reports on deliveries to Indonesia indicate delivery of 20mil doses by the end of Dec 2021.Reuters reported on 18 November that, “India allows export of 20 mln Novavax vaccine doses to Indonesia -document, source”.Shipment is likely to happen towards the end of next month, one of the sources said. Further reporting has SII potentially producing up to 100mil doses by the end of Dec 2021.</p><p><blockquote>“不过，他澄清说，没有禁止疫苗出口，因为卫生部、商业和工业部、工业促进和国内贸易部以及对外贸易总局都没有发布任何正式命令，要求禁止从该国出口 COVID-19 疫苗。COVID 疫苗的出口可能在 2022 年之前不会恢复。挖掘有关向印度尼西亚交付的新闻报道显示，到2021年12月底，将交付2000万剂疫苗。路透社11月18日报道称，“印度允许向印度尼西亚出口2000万剂诺瓦瓦克斯疫苗——文件，消息来源”。其中一位消息人士称，发货可能会在下月底左右进行。进一步报道称，到2021年12月底，SII有可能生产多达1亿剂。</blockquote></p><p> The very bullish investment thesis for Novavax is still intact but investors cannot be expected to have tunnel vision on SII. Investors need quality communication from Novavax to maintain that investment thesis. The vacuum of information on the big picture for manufacturing, stockpiles, shipments, revenue, and income encourages wild speculation and rumor mongering.</p><p><blockquote>Novavax 非常乐观的投资论点仍然完好无损，但不能指望投资者对 SII 抱有狭隘的看法。投资者需要 Novavax 的高质量沟通来维持这一投资论点。关于制造、库存、运输、收入和收入的大局信息真空鼓励了疯狂的投机和谣言传播。</blockquote></p><p> <b>Burning Questions around Manufacturing, Stockpile and Shipments.</b></p><p><blockquote><b>围绕制造、库存和运输的紧迫问题。</b></blockquote></p><p></p><p> No amount of digging could provide substantiated answers to the following questions which are vital for investors to make informed decisions on investing in Novavax shares. Investors are forced to infer or speculate on the answers to many of these questions in the absence of facts. Perhaps some of these questions will be answered in the Fireside Chat with Evercore. Perhaps Novavax will become more forthcoming about its activities, but investors are desperate for reliable information. Most companies go out of their way to sit down with analysts and give them quality information empowering them to achieve the same outcomes as the guidance of the company. Novavax has been skirting the questions around manufacturing, stockpiles and shipments and it has become pressing for investors to have reliable information.</p><p><blockquote>再多的挖掘也无法为以下问题提供确凿的答案，这些问题对于投资者在投资 Novavax 股票时做出明智的决定至关重要。在缺乏事实的情况下，投资者被迫推断或推测其中许多问题的答案。也许其中一些问题会在与Evercore的炉边聊天中得到解答。也许 Novavax 会对其活动更加坦诚，但投资者迫切需要可靠的信息。大多数公司都会不遗余力地与分析师坐下来，为他们提供高质量的信息，使他们能够实现与公司指导相同的结果。Novavax 一直回避有关制造、库存和运输的问题，投资者迫切需要获得可靠的信息。</blockquote></p><p> The questions which follows can't be answered from available information. Investors are at risk in the absence of the information which should be readily available to be packaged for investors. Each question will be followed by an explanation why the information is important.</p><p><blockquote>以下问题无法从现有信息中回答。由于缺乏本应随时为投资者打包的信息，投资者面临风险。每个问题之后都会解释为什么这些信息很重要。</blockquote></p><p> <b>Manufacturing Questions</b></p><p><blockquote><b>制造问题</b></blockquote></p><p></p><p> <ol> <li>Why has no other manufacturing facility, particularly the Novavax specific facilities, been submitted yet? Importance: Novavax was following a holistic approach towards achieving regulatory approval for all its manufacturing facilities up to the point when the Politico article was published on 19 October 2021. \"...we’ve built a global manufacturing infrastructure over the last year that has a robust eight different antigen manufacturing facilities in seven different countries.\" On 27 October 2021 Novavax filed for authorization of its vaccine in the UK and that filing was narrowed from a \"global manufacturing infrastructure\" to a single manufacturer filing that \"leverages our manufacturing partnership with the Serum Institute of India.In the near future, we expect to supplement this filing with supply from our global supply chain.\" All subsequent regulatory filings since 27 October 2021, other than South Korea were done in the same manner, leveraging SII as manufacturer.</li> <li>Will all facilities now manufacture components and export them to SII for manufacturing or fill & finish? Importance: Stanley Erck, CEO of Novavax said at the EC: \"And so they (SII) have fill finish capacity that's virtually unlimited. We can make many hundreds of millions of doses per month in their facility. And we've also signed an agreement with them, if we want for them to make product for high income markets. And so we have a CDMO agreement with them. And so they wouldn't supply as finished product, whether in one of two ways either from antigen, these spike protein that they make at Serum, or from spike protein that we make in our various sites around the world.\" The shift to SII seems to also imply greater reliance on the manufacturing capabilities of SII. It is important for investors to understand the implications of this shift.</li> <li>Can SII export any vaccine doses without approvals from the Indian government? Importance: As indicated above, exports of COVID vaccines from India are presently subject to, at the very least, Indian government approvals. The shift towards utilizing SII manufacturing facilities requires understanding of the potential risk associated with reliance on a single manufacturer and single country.</li> <li>SII reported communication on manufacturing is materially more conservative than Novavax reports, indicating only up to 100mil doses manufactured by the end of Dec 2021. Why the difference? Importance: John Trizzino said at the EC: \"Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter.\" SII as quoted above expect to produce up to 100mil doses by the end of Dec 2021. The discrepancy between Novavax and SII is, between 150mil doses per month vs up to 100mil doses by the end of Dec 2021.</li> <li>How much actual manufacturing of regulatory compliant vaccine doses are taking place at Novavax manufacturing facilities and all partner facilities? Not capacity, actual manufacturing. Importance: Novavax describes manufacturing as \"manufacturing capacity\" (see 4 above). SII indicated production of up to 100mil doses by the end of Dec 2021 and presently is the only manufacturer put forward in regulatory filings. Investors need information on the activities of the other manufacturers in the global manufacturing network to support the investment thesis particularly looking at 2022 and beyond. How and when would they start contributing to actual doses being available for deliveries?</li> <li>When will all other manufacturing facilities be submitted for regulatory approvals? Importance: All other manufacturing facilities were supposed to have been included in the \"near future\" which is ambiguous. It's one month later and no guidance or filings have been made for any of these facilities.</li> <li>What is the manufacturing guidance from all facilities say by Q1, Q2, Q3 and full year? Not capacity guidance, actual manufactured doses, regulatory compliant and available for shipment and delivery. Importance: This question follows from 6 above and the guidance is needed to estimate the revenue and income potential for Novavax during those periods. Novavax provided no guidance on full year 2021 or 2022 earnings during the EC.</li> <li>Investors will need information on manufacturing at the different facilities to allow for reasoned estimates of sales into different regions as well as COVAX. What will be the composition of manufacturing and delivery for low value sales and for high value sales? Importance: Novavax's reported sales prices range from $3 per dose to $21. The allocations of manufactured doses from the various manufacturing facilities are important indicators of the potential revenue which can be expected from those deliveries. It is expected that a material portion of the SII manufacturing will initially go to COVAX and into markets where </p><p><blockquote><ol><li>为什么还没有提交其他制造设施，特别是Novavax特定设施？重要性：在 2021 年 10 月 19 日发表 Politico 文章之前，Novavax 一直在遵循整体方法来获得其所有制造设施的监管部门批准。“......在过去的一年里，我们建立了一个全球制造基础设施，在七个不同的国家拥有八个不同的抗原制造设施。”2021 年 10 月 27 日，Novavax 在英国申请其疫苗授权，该申请范围从“全球制造基础设施”缩小到“利用我们与印度血清研究所的制造合作伙伴关系”的单一制造商申请。在不久的将来，我们希望通过来自我们全球供应链的供应来补充这份申请。”自2021年10月27日起，除韩国外，所有后续监管备案均以相同方式完成，利用SII作为制造商。</li><li>所有工厂现在都会制造零部件并出口到 SII 进行制造或灌装和精加工吗？重要性：Novavax 首席执行官 Stanley Erck 在 EC 上表示：“因此，他们（SII）拥有几乎无限的灌装产能。我们每月可以在他们的工厂生产数亿剂疫苗。如果我们希望他们为高收入市场生产产品，我们还与他们签署了一项协议。因此，我们与他们签订了 CDMO 协议。因此，他们不会以两种方式之一提供成品，要么来自抗原（他们在血清中制造的刺突蛋白），要么来自我们在世界各地各个地点制造的刺突蛋白。”向SII的转变似乎也意味着对SII制造能力的更大依赖。对于投资者来说，了解这种转变的影响非常重要。</li><li>未经印度政府批准，SII可以出口任何疫苗剂量吗？重要性：如上所述，印度出口的COVID疫苗目前至少要经过印度政府的批准。向利用SII制造设施的转变需要了解与依赖单一制造商和单一国家相关的潜在风险。</li><li>SII 报告的制造沟通比 Novavax 报告的要保守得多，表明截至 2021 年 12 月底，仅生产了多达 1 亿剂疫苗。为什么会有区别？重要性：John Trizzino 在 EC 上表示：“展望未来几个月，我们预计到第四季度末将实现每月 1.5 亿剂的产能。”上面引用的SII预计到2021年12月底将生产多达1亿剂。Novavax和SII之间的差异是，到2021年12月底，每月1.5亿剂剂量高达1亿剂。</li><li>Novavax生产设施和所有合作伙伴设施实际生产了多少符合法规的疫苗剂量？不是产能，而是实际制造。重要性：Novavax将制造描述为“制造能力”（见上文4）。SII 表示，到 2021 年 12 月底，产量将达到 1 亿剂，目前是唯一一家在监管文件中提出的制造商。投资者需要有关全球制造网络中其他制造商活动的信息，以支持投资论点，特别是着眼于 2022 年及以后。他们将如何以及何时开始为实际分娩剂量做出贡献？</li><li>所有其他制造设施何时提交监管部门批准？重要性：所有其他制造设施都应该包括在“不久的将来”中，这是模棱两可的。一个月过去了，这些设施都没有得到指导或备案。</li><li>第一季度、第二季度、第三季度和全年所有工厂的制造指导是什么？无容量指南、实际生产剂量、符合法规并可用于装运和交付。重要性：这个问题源于上述6点，需要指导来估计Novavax在这些时期的收入和收入潜力。Novavax 在 EC 期间没有提供 2021 年或 2022 年全年收益指导。</li><li>投资者将需要有关不同工厂生产的信息，以便对不同地区以及 COVAX 的销售额进行合理估计。低价值销售和高价值销售的制造和交付构成是什么？重要性：Novavax 报告的销售价格从每剂 3 美元到 21 美元不等。来自各个制造设施的制造剂量的分配是可以预期从这些交付中获得的潜在收入的重要指标。预计 SII 制造的很大一部分最初将流向 COVAX 并进入以下市场</li></ol></blockquote></p><p></p><p> <ol> <li>What is the size of the actual stockpile at SII, tens of millions can be 20mil doses or up to 90mil doses, it is far too inexact? Importance: The Novavax CEO answered at the EC: \"Well, I think I answered the second part of the question that SII will be the initial manufacturer. They've already made many 10s of millions of doses that are waiting to be shippable. They're sitting we've -- my team has physically gone over there and touched them.\" The stockpile can theoretically be shipped with immediate effect and generate income still in 2021. The actual size matters.</li> <li>What is the size of the regulatory compliant stockpile of doses at all facilities combined, again, tens of millions are not exact enough? Importance: The communication at the EC was very fragmented but it seems that there may be inventory other than that at SII. Novavax CEO: \"And for each of these, we're trying to allocate product both that we have in inventory in the U.S. and Europe and South Korea and an inventory that's being built up at Serum...\" Better understanding of regulatory compliant available inventory at all facilities will inform investor expectations on the timing of revenue as well as the expected quantum thereof.</li> <li>What is the breakdown of the stockpile at the various manufacturing facilities, those able to deliver a finished product? Importance: A breakdown of the stockpile will guide investor expectations regarding potential income from high value deliveries vs low value deliveries and the timing thereof.</li> <li>There has been rumor that the 20mil dose export from SII was approved because of its expiry date, rumor is not where information should originate from. How dated is the various stockpiles?</li> </ol> <b>Shipment and Delivery Questions</b></p><p><blockquote><ol><li>SII的实际库存是多少，几千万可以是2000万剂，也可以是9000万剂，这太不准确了？重要性：Novavax 首席执行官在 EC 上回答道：“嗯，我想我回答了问题的第二部分，即 SII 将成为最初的制造商。他们已经生产了数千万剂等待发货。他们坐在那里我们已经——我的团队已经亲自去那里触摸了他们。”理论上，该库存可以立即发货，并在2021年仍然产生收入。实际尺寸很重要。</li><li>所有设施的合规剂量库存总和是多少，同样，数千万是不够准确的？重要性：欧共体的沟通非常分散，但似乎除了SII之外，可能还有其他库存。Novavax 首席执行官：“对于每一个产品，我们都在尝试分配我们在美国、欧洲和韩国库存中的产品以及 Serum 正在建立的库存……”更好地了解所有设施的合规可用库存将为投资者对收入时间及其预期数量的预期提供信息。</li><li>能够交付成品的各种制造工厂的库存明细是什么？重要性：库存明细将指导投资者对高价值交付与低价值交付的潜在收入及其时机的预期。</li><li>有传言称，从SII出口的2000万剂量是因为其有效期而被批准的，谣言不是信息应该来自哪里。各种库存有多久远？</li></ol><b>运输和交付问题</b></blockquote></p><p> <ol> <li>Why will the 20mil shipment to Indonesia only take place by the end of Dec 2021 if the doses are available in stockpile right now? Importance: Novavax CEO at the EC: \"We've expect that initial shipments into Indonesia by Serum will begin imminently.\" The guidance of SII on delivery to Indonesia clearly differs from the comment by the CEO of Novavax. This question also has a larger context. How many doses can be expected to be shipped still in 2021 which will translate into revenue and income for the full year results EC in March 2022?</li> <li>Why only 20mil doses? Importance: SII has tens of millions of doses in stockpile and can manufacture up to 100mil doses be the end of Dec 2021 yet only 20mil doses out of a 50mil doses order by Indonesia are expected to be shipped by end of Dec 2021.</li> <li>How many doses are SII expected to ship in 2021? Importance: This question follows on q2 above. There are potential doses for shipment from stockpile and from manufacturing yet only 20mil has been reported.</li> <li>Where will doses be shipped from in 2022, which manufacturing facilities? Importance: The shift in emphasis to SII for the time being raises this question. Which of the other manufacturing facilities in the global manufacturing network will be designated to ship finished product?</li> <li>How many doses are expected be shipped and delivered in H1 and full year in 2022. Importance: All of the Novavax guidance is \"manufacturing capacity\" which informs investors what the maximum potential production capacity may be, but it does not inform the investor how much actual manufacturing can be expected within a given period, manufactured product which can be delivered under sales agreements.</li> <li>Why are no shipments to the Philippines scheduled so far? Importance: A tiny shipment of 20mil doses has been reported for Indonesia but no scheduled delivery to the Philippines has been reported so far.</li> </ol> Filing for regulatory approvals in the name of SII as manufacturer surely advances the standing of the Novavax vaccine but it needs to be backed up by manufacturing and an ability to export the vaccines to those countries who had purchased doses. The presence of the Indian government looms large in the manufacturing and shipments of doses from SII. This vulnerability of Novavax to a single supplier/manufacturer must be explored and understood. Yes, the other facilities will in time also contribute, but guidance so far has been that those facilities should have been in play already and they are not. Investors need to understand, why not? When will those facilities contribute regulatory approved doses and contribute to the revenue and income of Novavax?</p><p><blockquote><ol><li>如果现在有库存，为什么2000万剂运往印度尼西亚要到2021年12月底才会发货？重要性：Novavax 欧盟委员会首席执行官：“我们预计血清将很快开始向印度尼西亚发货。”SII 关于向印度尼西亚交付的指导显然与 Novavax 首席执行官的评论不同。这个问题还有一个更大的背景。预计2021年仍有多少剂量可以运输，这将转化为2022年3月EC全年业绩的收入和收益？</li><li>为什么只有2000万剂？重要性：SII有数千万剂库存，到2021年12月底可以生产多达1亿剂，但印度尼西亚5000万剂订单中只有2000万剂预计到2021年12月底发货。</li><li>SII预计在2021年出货多少剂？重要性：这个问题出现在上面的第二季度。有从库存和生产中发货的潜在剂量，但据报道只有2000万剂。</li><li>2022年，剂量将从哪里运送，哪些制造工厂？重要性：目前重点转移到SII提出了这个问题。全球制造网络中的哪些其他制造设施将被指定用于运输成品？</li><li>预计2022年上半年和全年将发货和交付多少剂。重要性：Novavax 的所有指南都是“生产能力”，它告知投资者最大潜在生产能力可能是多少，但它没有告知投资者在给定时期内可以预期实际生产量，即可以根据销售协议交付的制成品。</li><li>为什么到目前为止还没有安排向菲律宾发货？重要性：据报道，印度尼西亚有2000万剂疫苗的少量运输，但到目前为止，还没有向菲律宾交付的计划。</li></ol>以 SII 作为制造商的名义申请监管部门批准无疑会提高 Novavax 疫苗的地位，但它需要得到制造和向已购买疫苗的国家出口疫苗的能力的支持。印度政府在SII疫苗的制造和运输中起着重要作用。必须探索和理解Novavax对单一供应商/制造商的这种脆弱性。是的，其他设施也将及时做出贡献，但到目前为止，指导是这些设施应该已经投入使用，但它们没有。投资者需要明白，为什么不呢？这些设施何时会提供监管批准的剂量并为 Novavax 的收入和收益做出贡献？</blockquote></p><p> <b>Conclusion</b></p><p><blockquote><b>结论</b></blockquote></p><p></p><p> Novavax has made good progress since the Politico article to prove its ability to manufacture and deliver vaccine doses. Concentrating all the filings and all the manufacturing at SII are exposing Novavax to a single source manufacturer/supplier and political risk. The absence of information on manufacturing, stockpiles and shipments have become burning questions for investors. 2021 is almost over and only one shipment for 20mil vaccine doses is scheduled for the end of Dec 2021. It is hoped that Novavax will initiate a process to provide quality information on the burning questions around manufacturing, stockpiles and shipments and perhaps deal with some of it at the Evercore Fireside Chat. Investors require quality information to inform their decisions to buy Novavax shares and hold them based upon an informed investment thesis. The information currently available is lacking in that regard given a significant strategic shift by Novavax since the publication of the Politico article.</p><p><blockquote>自Politico文章以来，Novavax在证明其制造和交付疫苗剂量的能力方面取得了良好进展。将所有备案和所有制造集中在SII，使Novavax面临单一来源制造商/供应商和政治风险。缺乏制造、库存和发货信息已成为投资者亟待解决的问题。2021 年即将结束，只有一批 2000 万剂疫苗计划于 2021 年 12 月底发货。希望 Novavax 能够启动一个流程，提供有关制造、库存和运输等紧迫问题的质量信息，并可能在 Evercore 炉边聊天中处理其中的一些问题。投资者需要高质量的信息来为他们购买 Novavax 股票的决定提供信息，并根据明智的投资论点持有这些股票。鉴于自 Politico 文章发表以来 Novavax 发生了重大战略转变，目前可获得的信息在这方面缺乏。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://seekingalpha.com/article/4471943-novavax-nvax-stock-some-burning-questions\">Seeking Alpha</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"source_url":"https://seekingalpha.com/article/4471943-novavax-nvax-stock-some-burning-questions","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1172101126","content_text":"Summary\n\nNovavax is making good progress with SII backed regulatory filings.\nSII and the Indian government “ban” on COVID vaccine exports are a necessary vulnerability in the short term.\nInvestors cannot have tunnel vision on SII and Novavax must urgently provide answers on manufacturing, stockpiles, and shipments.\n\nMaria Golenishcheva/iStock via Getty Images\nNovavax(NASDAQ:NVAX)has announced its intention to participate in a Fireside Chat at Evercore ISI's 4th Annual HealthCONx Virtual Conference on 2 December 2021. This is the first event at which Novavax will participate since the Earnings Call(EC)on 4 November 2021.BioNTech(NASDAQ:BNTX) has participated in 3 events since their EC on 9 Nov including the Jefferies London Healthcare Conference and will also participate in the Evercore event.Moderna(NASDAQ:MRNA) also has participated in 3 events since their EC on 4 Nov and have announced participation in two more before 2 Dec but has not yet advised if they will be attending Evercore. Participating at events provide investors with general information. Novavax's absence form events in November has left a lot of questions unanswered.\nNovavax has announced the following successes since the EC:\n\nSubmission of Biologics License Application in South Korea for Approval of NVX-CoV2373.\nNovavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines.\nNovavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization.\nNovavax Files for Interim Authorization of COVID-19 Vaccine in Singapore.\n\nThe Novavax progress continues but at the same time the vacuum of information on manufacturing and delivery remains. It is important to discuss the burning questions and the lack of information on manufacturing, stockpile, and delivery.\nNone of the recent notices made specific reference to manufacturing or delivery. The notice on the Philippines is not clear on whether SII will be delivering vaccine doses to the Philippines at all or whether SII must first construct a manufacturing facility in the Philippines from which vaccines will be delivered. The statement reads, “The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™.” Why this wording “manufactured and marketed in the Philippines”? Was it just clumsy or not? The Philippines announced an intention in March 2021 to partner with SII for manufacturing in the Philippines.\n\n “PH eyes local vaccine production with Serum Institute of India” March 17, 2021.\n\nIndia has a general “restriction” on the export of COVID vaccines from India. It’s an unofficial “ban” on exports which are only allowed with government of India approval. It is also disconcerting that the application for approval of the Novavax vaccine has been submitted to India already on 5 August 2021 and it has not yet been approved by India.\n\n “He, however, clarified there was no ban on vaccine exports as neither the health ministry, commerce and industry ministry, department of promotion of industry and internal trade, nor the directorate general of foreign trade has issued any formal orders asking to bar the export of COVID-19 vaccines from the country.”COVID vaccines’ export may not resume before 2022.\n\nDigging in news reports on deliveries to Indonesia indicate delivery of 20mil doses by the end of Dec 2021.Reuters reported on 18 November that, “India allows export of 20 mln Novavax vaccine doses to Indonesia -document, source”.Shipment is likely to happen towards the end of next month, one of the sources said. Further reporting has SII potentially producing up to 100mil doses by the end of Dec 2021.\nThe very bullish investment thesis for Novavax is still intact but investors cannot be expected to have tunnel vision on SII. Investors need quality communication from Novavax to maintain that investment thesis. The vacuum of information on the big picture for manufacturing, stockpiles, shipments, revenue, and income encourages wild speculation and rumor mongering.\nBurning Questions around Manufacturing, Stockpile and Shipments.\nNo amount of digging could provide substantiated answers to the following questions which are vital for investors to make informed decisions on investing in Novavax shares. Investors are forced to infer or speculate on the answers to many of these questions in the absence of facts. Perhaps some of these questions will be answered in the Fireside Chat with Evercore. Perhaps Novavax will become more forthcoming about its activities, but investors are desperate for reliable information. Most companies go out of their way to sit down with analysts and give them quality information empowering them to achieve the same outcomes as the guidance of the company. Novavax has been skirting the questions around manufacturing, stockpiles and shipments and it has become pressing for investors to have reliable information.\nThe questions which follows can't be answered from available information. Investors are at risk in the absence of the information which should be readily available to be packaged for investors. Each question will be followed by an explanation why the information is important.\nManufacturing Questions\n\nWhy has no other manufacturing facility, particularly the Novavax specific facilities, been submitted yet? Importance: Novavax was following a holistic approach towards achieving regulatory approval for all its manufacturing facilities up to the point when the Politico article was published on 19 October 2021. \"...we’ve built a global manufacturing infrastructure over the last year that has a robust eight different antigen manufacturing facilities in seven different countries.\" On 27 October 2021 Novavax filed for authorization of its vaccine in the UK and that filing was narrowed from a \"global manufacturing infrastructure\" to a single manufacturer filing that \"leverages our manufacturing partnership with the Serum Institute of India.In the near future, we expect to supplement this filing with supply from our global supply chain.\" All subsequent regulatory filings since 27 October 2021, other than South Korea were done in the same manner, leveraging SII as manufacturer.\nWill all facilities now manufacture components and export them to SII for manufacturing or fill & finish? Importance: Stanley Erck, CEO of Novavax said at the EC: \"And so they (SII) have fill finish capacity that's virtually unlimited. We can make many hundreds of millions of doses per month in their facility. And we've also signed an agreement with them, if we want for them to make product for high income markets. And so we have a CDMO agreement with them. And so they wouldn't supply as finished product, whether in one of two ways either from antigen, these spike protein that they make at Serum, or from spike protein that we make in our various sites around the world.\" The shift to SII seems to also imply greater reliance on the manufacturing capabilities of SII. It is important for investors to understand the implications of this shift.\nCan SII export any vaccine doses without approvals from the Indian government? Importance: As indicated above, exports of COVID vaccines from India are presently subject to, at the very least, Indian government approvals. The shift towards utilizing SII manufacturing facilities requires understanding of the potential risk associated with reliance on a single manufacturer and single country.\nSII reported communication on manufacturing is materially more conservative than Novavax reports, indicating only up to 100mil doses manufactured by the end of Dec 2021. Why the difference? Importance: John Trizzino said at the EC: \"Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter.\" SII as quoted above expect to produce up to 100mil doses by the end of Dec 2021. The discrepancy between Novavax and SII is, between 150mil doses per month vs up to 100mil doses by the end of Dec 2021.\nHow much actual manufacturing of regulatory compliant vaccine doses are taking place at Novavax manufacturing facilities and all partner facilities? Not capacity, actual manufacturing. Importance: Novavax describes manufacturing as \"manufacturing capacity\" (see 4 above). SII indicated production of up to 100mil doses by the end of Dec 2021 and presently is the only manufacturer put forward in regulatory filings. Investors need information on the activities of the other manufacturers in the global manufacturing network to support the investment thesis particularly looking at 2022 and beyond. How and when would they start contributing to actual doses being available for deliveries?\nWhen will all other manufacturing facilities be submitted for regulatory approvals? Importance: All other manufacturing facilities were supposed to have been included in the \"near future\" which is ambiguous. It's one month later and no guidance or filings have been made for any of these facilities.\nWhat is the manufacturing guidance from all facilities say by Q1, Q2, Q3 and full year? Not capacity guidance, actual manufactured doses, regulatory compliant and available for shipment and delivery. Importance: This question follows from 6 above and the guidance is needed to estimate the revenue and income potential for Novavax during those periods. Novavax provided no guidance on full year 2021 or 2022 earnings during the EC.\nInvestors will need information on manufacturing at the different facilities to allow for reasoned estimates of sales into different regions as well as COVAX. What will be the composition of manufacturing and delivery for low value sales and for high value sales? Importance: Novavax's reported sales prices range from $3 per dose to $21. The allocations of manufactured doses from the various manufacturing facilities are important indicators of the potential revenue which can be expected from those deliveries. It is expected that a material portion of the SII manufacturing will initially go to COVAX and into markets where the sales price would be towards the lower bound while the manufacturing at the other facilities in the EU, UK and USA may generate higher revenues. Novavax CEO at the EC: \"Serum is going to make the bulk of the production over the next few months. We are going to allocate. We're going to focus on COVAX, and make sure that they get their allocation, it won't be 100% of our product out of there. But it will be a large portion for the first few months. And then it'll shift over to our APAs in large quantities, I think in the second, third quarter. So this quarter and next quarter, we have a lot of our mission is to get a lot of product out to low and middle income countries...\" Better understanding of the revenue potential is required. Does this statement mean that Novavax will only start generating significant income from Q3 onwards? Will the EC's between now and November 2022 be relatively thin on revenue and income? The language of \"near future\" on facilities other than SII is in conflict with the language of SII manufacturing the bulk over the \"next few months\".\n\nStockpile Questions\n\nWhat is the size of the actual stockpile at SII, tens of millions can be 20mil doses or up to 90mil doses, it is far too inexact? Importance: The Novavax CEO answered at the EC: \"Well, I think I answered the second part of the question that SII will be the initial manufacturer. They've already made many 10s of millions of doses that are waiting to be shippable. They're sitting we've -- my team has physically gone over there and touched them.\" The stockpile can theoretically be shipped with immediate effect and generate income still in 2021. The actual size matters.\nWhat is the size of the regulatory compliant stockpile of doses at all facilities combined, again, tens of millions are not exact enough? Importance: The communication at the EC was very fragmented but it seems that there may be inventory other than that at SII. Novavax CEO: \"And for each of these, we're trying to allocate product both that we have in inventory in the U.S. and Europe and South Korea and an inventory that's being built up at Serum...\" Better understanding of regulatory compliant available inventory at all facilities will inform investor expectations on the timing of revenue as well as the expected quantum thereof.\nWhat is the breakdown of the stockpile at the various manufacturing facilities, those able to deliver a finished product? Importance: A breakdown of the stockpile will guide investor expectations regarding potential income from high value deliveries vs low value deliveries and the timing thereof.\nThere has been rumor that the 20mil dose export from SII was approved because of its expiry date, rumor is not where information should originate from. How dated is the various stockpiles?\n\nShipment and Delivery Questions\n\nWhy will the 20mil shipment to Indonesia only take place by the end of Dec 2021 if the doses are available in stockpile right now? Importance: Novavax CEO at the EC: \"We've expect that initial shipments into Indonesia by Serum will begin imminently.\" The guidance of SII on delivery to Indonesia clearly differs from the comment by the CEO of Novavax. This question also has a larger context. How many doses can be expected to be shipped still in 2021 which will translate into revenue and income for the full year results EC in March 2022?\nWhy only 20mil doses? Importance: SII has tens of millions of doses in stockpile and can manufacture up to 100mil doses be the end of Dec 2021 yet only 20mil doses out of a 50mil doses order by Indonesia are expected to be shipped by end of Dec 2021.\nHow many doses are SII expected to ship in 2021? Importance: This question follows on q2 above. There are potential doses for shipment from stockpile and from manufacturing yet only 20mil has been reported.\nWhere will doses be shipped from in 2022, which manufacturing facilities? Importance: The shift in emphasis to SII for the time being raises this question. Which of the other manufacturing facilities in the global manufacturing network will be designated to ship finished product?\nHow many doses are expected be shipped and delivered in H1 and full year in 2022. Importance: All of the Novavax guidance is \"manufacturing capacity\" which informs investors what the maximum potential production capacity may be, but it does not inform the investor how much actual manufacturing can be expected within a given period, manufactured product which can be delivered under sales agreements.\nWhy are no shipments to the Philippines scheduled so far? Importance: A tiny shipment of 20mil doses has been reported for Indonesia but no scheduled delivery to the Philippines has been reported so far.\n\nFiling for regulatory approvals in the name of SII as manufacturer surely advances the standing of the Novavax vaccine but it needs to be backed up by manufacturing and an ability to export the vaccines to those countries who had purchased doses. The presence of the Indian government looms large in the manufacturing and shipments of doses from SII. This vulnerability of Novavax to a single supplier/manufacturer must be explored and understood. Yes, the other facilities will in time also contribute, but guidance so far has been that those facilities should have been in play already and they are not. Investors need to understand, why not? When will those facilities contribute regulatory approved doses and contribute to the revenue and income of Novavax?\nConclusion\nNovavax has made good progress since the Politico article to prove its ability to manufacture and deliver vaccine doses. Concentrating all the filings and all the manufacturing at SII are exposing Novavax to a single source manufacturer/supplier and political risk. The absence of information on manufacturing, stockpiles and shipments have become burning questions for investors. 2021 is almost over and only one shipment for 20mil vaccine doses is scheduled for the end of Dec 2021. It is hoped that Novavax will initiate a process to provide quality information on the burning questions around manufacturing, stockpiles and shipments and perhaps deal with some of it at the Evercore Fireside Chat. Investors require quality information to inform their decisions to buy Novavax shares and hold them based upon an informed investment thesis. The information currently available is lacking in that regard given a significant strategic shift by Novavax since the publication of the Politico article.","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":687,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":1,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/877372817"}
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