KLF
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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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：NVAX）宣布有意参加2021年12月2日Evercore ISI第四届年度HealthCONx虚拟会议的炉边谈话。这是Novavax自2021年11月4日看涨期权(EC)以来参加的首次活动。BioNTech（纳斯达克：BNTX）自11月9日EC以来已参加了3场活动，包括Jefferies London Healthcare Conference，并将参加Evercore活动。Moderna（纳斯达克：MRNA）自11月4日EC以来也参加了3场活动，并宣布在12月2日之前参加另外两场活动，但尚未告知他们是否会参加Evercore。参加活动为投资者提供一般信息。Novavax缺席11月份的活动留下了许多悬而未决的问题。</blockquote></p><p> Novavax has announced the following successes since the EC:</p><p><blockquote>自EC以来，Novavax已宣布取得以下成功：</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>在韩国提交生物制品许可申请以批准NVX-CoV2373。</li><li>Novavax和印度血清研究所获得新冠肺炎疫苗在菲律宾的紧急使用授权。</li><li>Novavax确认欧洲药品管理局对新冠肺炎疫苗有条件上市许可申请的审查。</li><li>Novavax在新加坡申请新冠肺炎疫苗的临时授权。</li></ul>Novavax的进展仍在继续，但与此同时，有关制造和交付的信息真空仍然存在。讨论紧迫的问题以及缺乏关于制造、库存和交付的信息是很重要的。</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>最近的通知都没有具体提到制造或交付。关于菲律宾的通知不清楚SII是否会向菲律宾运送疫苗，或者SII是否必须首先在菲律宾建造一个生产设施，从那里运送疫苗。声明中写道，“该疫苗将由SII以COVOVAX品牌在菲律宾生产和销售。”™为什么是“在菲律宾制造和销售”？是不是很笨拙？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关注印度血清研究所的本地疫苗生产”2021年3月17日。印度对从印度出口COVID疫苗有普遍的“限制”。这是一项非官方的出口“禁令”，只有在印度政府批准的情况下才允许。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>“然而，他澄清说，没有禁止疫苗出口，因为卫生部、商业和工业部、工业和国内贸易部以及外贸总局都没有发布任何正式命令，要求禁止从该国出口新冠肺炎疫苗。”COVID疫苗的出口可能不会在2022年之前恢复。挖掘关于向印度尼西亚交付的新闻报道表明，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Novavax疫苗——文件，来源”。其中一位消息人士称，发货可能会在下月底进行。进一步报告称，到2021年12月底，SII可能会生产多达1亿剂疫苗。</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、收入和收入的信息真空鼓励了疯狂的猜测和谣言传播。</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策至关重要。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的炉边谈话中得到解答。也许Novavax会更加公开其活动，但投资者迫切需要可靠的信息。大多数公司都会特意与分析师坐下来，向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>接下来的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>为什么尚未提交其他生产设施，特别是Novavax特定设施？重要性：在Politico文章于2021年10月19日发表之前，Novavax一直在采取整体方法来获得监管机构的批准。“……去年我们建立了全球制造基础设施，在七个不同的国家拥有强大的八个不同的抗原制造设施。”2021年10月27日，Novavax在英国申请了其疫苗的授权，该申请从“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，我们预计将通过我们全球供应链的供应来补充该文件。”自2021年10月27日以来，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组件并将其出口到SII进行制造或灌装和精加工吗？重要性：Novavax首席执行官Stanley Erck在欧盟委员会上表示：“因此，他们（SII）拥有几乎无限的灌装能力。我们每个月可以在他们的工厂生产数亿剂。如果我们想让他们为高收入市场生产产品，我们也和他们签署了协议。所以我们和他们有CDMO协议。因此，他们不会作为成品供应，无论是通过两种方式之一，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，理解这一转变的影响非常重要。</li><li>没有印度政府的批准，SII可以出口任何疫苗剂量吗？重要性：如上所述，从印度出口COVID疫苗目前至少需要印度政府的批准。转向利用SII制造设施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报告的关于生产的沟通比Novavax的报告要保守得多，表明到2021年12月底仅生产了多达1亿剂。为什么会有区别？重要性：John Trizzino在EC表示：“展望未来几个月，我们预计到第四季度末将实现每月1.5亿剂的生产能力。”如上所述，SII预计到2021年12月底将生产多达1亿剂疫苗。Novavax和SII之间的差异是，到2021年12月底，每月1.5亿剂与高达1亿剂之间。</li><li>Novavax生产工厂和所有合作伙伴工厂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年及以后的投资论点。他们将如何以及何时开始为可用于分娩的实际剂量做出贡献？</li><li>所有其他生产设施何时提交监管机构批准？重要性：所有其他制造设施都应该包括在“不久的将来”中，这是模糊的。一个月后，还没有对这些设施进行指导或备案。</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？不是容量指南，实际生产剂量，符合法规，可用于装运和交付。重要性：这个问题来自上面的6个问题，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年全年收益指引。</li><li>投资者将需要有关不同工厂生产的信息，以便合理估计不同地区以及COVAX的销售额。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。来自各种制造设施的制造剂量的分配是可以从这些交付中预期的潜在收入的重要指标。预计SII制造的重要部分最初将流向COVAX和以下市场：</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的实际库存有多大，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，我想我已经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疫苗，等待发货。他们坐在那里，我们——我的团队亲自去那里触摸了他们。”理论上，库存可以立即发货，并在2021年仍能产生收入。实际大小很重要。</li><li>所有设施的合规剂量库存加起来有多大，同样，数千万还不够准确？重要性：欧共体的沟通非常分散，但似乎除了SII之外，可能还有其他清单。Novavax首席执行官：“对于每一种产品，我们都在尝试分配美国、欧洲和韩国库存的产品以及Serum正在建立的库存……”更好地了解所有设施中符合法规的可用库存将告知投资者对收入时间及其预期数量的预期。</li><li>能够交付成品的各种制造设施的库存细目是什么？重要性：库存的细分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间的预期。</li><li>有传言说，从SII出口的2000万剂疫苗因其有效期而被批准，谣言不是信息的来源。各种库存有多老？</li></ol><b>装运和交付问题</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2000万剂要到2021年12月底才能向印度尼西亚运送？重要性：Novavax首席执行官在欧盟表示：“我们预计血清将很快开始向印度尼西亚运送。”SII关于向印尼交货的指导与Novavax首席执行官的评论明显不同。这个问题还有一个更大的背景。预计2021年仍有多少剂量将转化为2022年3月全年业绩EC的收入和收入？</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，但印度尼西亚订购的5000万剂中只有2000万剂预计到2021年12月底发货。</li><li>SII预计在2021年发货多少剂？重要性：这个问题在上面的q2之后。库存和生产中都有潜在的剂量可供运输，但据报道只有2000万。</li><li>2022年，剂量将从哪里运送，哪些制造设施？重要性：重点暂时转移到SII提出了这个问题。全球制造网络中的哪些其他制造工厂将被指定运送成品？</li><li>预计2022年H1和全年将运送和交付多少剂疫苗。重要性：Novavax的所有指导都是“制造能力”，它告诉投资者最大潜在生产能力是多少，但它没有告诉投资者在给定时期内可以预期多少实际制造，可以根据销售协议交付的制造产品。</li><li>为什么到目前为止还没有计划向菲律宾发货？重要性：据报道，有2000万剂疫苗运往印度尼西亚，但到目前为止，还没有计划运往菲律宾的报道。</li></ol>以SII作为制造商的名义申请监管部门的批准肯定会提高Novavax疫苗的地位，但它需要得到制造和向购买疫苗的国家出口疫苗的能力的支持。在从SII制造和运输剂量方面，印度政府的存在举足轻重。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，但迄今为止的指导是，这些设施应该已经投入使用，但它们没有。投资者需要理解，何乐而不为呢？这些设施何时会贡献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发表文章以来，Novavax取得了良好进展，证明了其生产和提供疫苗剂量的能力。将所有备案和所有生产集中在SII使Novavax面临单一来源制造商/供应商和政治风险。缺乏有关制造、库存和出货量的信息已成为投资者面临的紧迫问题。2021年即将结束，只有一批2000万剂疫苗计划在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高质量信息，并可能在Evercore炉边谈话中解决其中一些问题。投资者需要高质量的信息来决定购买Novavax股票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，目前缺乏这方面的信息。</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支持的监管文件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来自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：NVAX）宣布有意参加2021年12月2日Evercore ISI第四届年度HealthCONx虚拟会议的炉边谈话。这是Novavax自2021年11月4日看涨期权(EC)以来参加的首次活动。BioNTech（纳斯达克：BNTX）自11月9日EC以来已参加了3场活动，包括Jefferies London Healthcare Conference，并将参加Evercore活动。Moderna（纳斯达克：MRNA）自11月4日EC以来也参加了3场活动，并宣布在12月2日之前参加另外两场活动，但尚未告知他们是否会参加Evercore。参加活动为投资者提供一般信息。Novavax缺席11月份的活动留下了许多悬而未决的问题。</blockquote></p><p> Novavax has announced the following successes since the EC:</p><p><blockquote>自EC以来，Novavax已宣布取得以下成功：</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>在韩国提交生物制品许可申请以批准NVX-CoV2373。</li><li>Novavax和印度血清研究所获得新冠肺炎疫苗在菲律宾的紧急使用授权。</li><li>Novavax确认欧洲药品管理局对新冠肺炎疫苗有条件上市许可申请的审查。</li><li>Novavax在新加坡申请新冠肺炎疫苗的临时授权。</li></ul>Novavax的进展仍在继续，但与此同时，有关制造和交付的信息真空仍然存在。讨论紧迫的问题以及缺乏关于制造、库存和交付的信息是很重要的。</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>最近的通知都没有具体提到制造或交付。关于菲律宾的通知不清楚SII是否会向菲律宾运送疫苗，或者SII是否必须首先在菲律宾建造一个生产设施，从那里运送疫苗。声明中写道，“该疫苗将由SII以COVOVAX品牌在菲律宾生产和销售。”™为什么是“在菲律宾制造和销售”？是不是很笨拙？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关注印度血清研究所的本地疫苗生产”2021年3月17日。印度对从印度出口COVID疫苗有普遍的“限制”。这是一项非官方的出口“禁令”，只有在印度政府批准的情况下才允许。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>“然而，他澄清说，没有禁止疫苗出口，因为卫生部、商业和工业部、工业和国内贸易部以及外贸总局都没有发布任何正式命令，要求禁止从该国出口新冠肺炎疫苗。”COVID疫苗的出口可能不会在2022年之前恢复。挖掘关于向印度尼西亚交付的新闻报道表明，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Novavax疫苗——文件，来源”。其中一位消息人士称，发货可能会在下月底进行。进一步报告称，到2021年12月底，SII可能会生产多达1亿剂疫苗。</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、收入和收入的信息真空鼓励了疯狂的猜测和谣言传播。</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策至关重要。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的炉边谈话中得到解答。也许Novavax会更加公开其活动，但投资者迫切需要可靠的信息。大多数公司都会特意与分析师坐下来，向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>接下来的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>为什么尚未提交其他生产设施，特别是Novavax特定设施？重要性：在Politico文章于2021年10月19日发表之前，Novavax一直在采取整体方法来获得监管机构的批准。“……去年我们建立了全球制造基础设施，在七个不同的国家拥有强大的八个不同的抗原制造设施。”2021年10月27日，Novavax在英国申请了其疫苗的授权，该申请从“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，我们预计将通过我们全球供应链的供应来补充该文件。”自2021年10月27日以来，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组件并将其出口到SII进行制造或灌装和精加工吗？重要性：Novavax首席执行官Stanley Erck在欧盟委员会上表示：“因此，他们（SII）拥有几乎无限的灌装能力。我们每个月可以在他们的工厂生产数亿剂。如果我们想让他们为高收入市场生产产品，我们也和他们签署了协议。所以我们和他们有CDMO协议。因此，他们不会作为成品供应，无论是通过两种方式之一，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，理解这一转变的影响非常重要。</li><li>没有印度政府的批准，SII可以出口任何疫苗剂量吗？重要性：如上所述，从印度出口COVID疫苗目前至少需要印度政府的批准。转向利用SII制造设施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报告的关于生产的沟通比Novavax的报告要保守得多，表明到2021年12月底仅生产了多达1亿剂。为什么会有区别？重要性：John Trizzino在EC表示：“展望未来几个月，我们预计到第四季度末将实现每月1.5亿剂的生产能力。”如上所述，SII预计到2021年12月底将生产多达1亿剂疫苗。Novavax和SII之间的差异是，到2021年12月底，每月1.5亿剂与高达1亿剂之间。</li><li>Novavax生产工厂和所有合作伙伴工厂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年及以后的投资论点。他们将如何以及何时开始为可用于分娩的实际剂量做出贡献？</li><li>所有其他生产设施何时提交监管机构批准？重要性：所有其他制造设施都应该包括在“不久的将来”中，这是模糊的。一个月后，还没有对这些设施进行指导或备案。</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？不是容量指南，实际生产剂量，符合法规，可用于装运和交付。重要性：这个问题来自上面的6个问题，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年全年收益指引。</li><li>投资者将需要有关不同工厂生产的信息，以便合理估计不同地区以及COVAX的销售额。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。来自各种制造设施的制造剂量的分配是可以从这些交付中预期的潜在收入的重要指标。预计SII制造的重要部分最初将流向COVAX和以下市场：</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的实际库存有多大，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，我想我已经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疫苗，等待发货。他们坐在那里，我们——我的团队亲自去那里触摸了他们。”理论上，库存可以立即发货，并在2021年仍能产生收入。实际大小很重要。</li><li>所有设施的合规剂量库存加起来有多大，同样，数千万还不够准确？重要性：欧共体的沟通非常分散，但似乎除了SII之外，可能还有其他清单。Novavax首席执行官：“对于每一种产品，我们都在尝试分配美国、欧洲和韩国库存的产品以及Serum正在建立的库存……”更好地了解所有设施中符合法规的可用库存将告知投资者对收入时间及其预期数量的预期。</li><li>能够交付成品的各种制造设施的库存细目是什么？重要性：库存的细分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间的预期。</li><li>有传言说，从SII出口的2000万剂疫苗因其有效期而被批准，谣言不是信息的来源。各种库存有多老？</li></ol><b>装运和交付问题</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2000万剂要到2021年12月底才能向印度尼西亚运送？重要性：Novavax首席执行官在欧盟表示：“我们预计血清将很快开始向印度尼西亚运送。”SII关于向印尼交货的指导与Novavax首席执行官的评论明显不同。这个问题还有一个更大的背景。预计2021年仍有多少剂量将转化为2022年3月全年业绩EC的收入和收入？</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，但印度尼西亚订购的5000万剂中只有2000万剂预计到2021年12月底发货。</li><li>SII预计在2021年发货多少剂？重要性：这个问题在上面的q2之后。库存和生产中都有潜在的剂量可供运输，但据报道只有2000万。</li><li>2022年，剂量将从哪里运送，哪些制造设施？重要性：重点暂时转移到SII提出了这个问题。全球制造网络中的哪些其他制造工厂将被指定运送成品？</li><li>预计2022年H1和全年将运送和交付多少剂疫苗。重要性：Novavax的所有指导都是“制造能力”，它告诉投资者最大潜在生产能力是多少，但它没有告诉投资者在给定时期内可以预期多少实际制造，可以根据销售协议交付的制造产品。</li><li>为什么到目前为止还没有计划向菲律宾发货？重要性：据报道，有2000万剂疫苗运往印度尼西亚，但到目前为止，还没有计划运往菲律宾的报道。</li></ol>以SII作为制造商的名义申请监管部门的批准肯定会提高Novavax疫苗的地位，但它需要得到制造和向购买疫苗的国家出口疫苗的能力的支持。在从SII制造和运输剂量方面，印度政府的存在举足轻重。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，但迄今为止的指导是，这些设施应该已经投入使用，但它们没有。投资者需要理解，何乐而不为呢？这些设施何时会贡献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发表文章以来，Novavax取得了良好进展，证明了其生产和提供疫苗剂量的能力。将所有备案和所有生产集中在SII使Novavax面临单一来源制造商/供应商和政治风险。缺乏有关制造、库存和出货量的信息已成为投资者面临的紧迫问题。2021年即将结束，只有一批2000万剂疫苗计划在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高质量信息，并可能在Evercore炉边谈话中解决其中一些问题。投资者需要高质量的信息来决定购买Novavax股票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，目前缺乏这方面的信息。</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":716,"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":12,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/877374047"}
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