Novavax: Some Burning Questions

Seeking Alpha2021-11-26

Summary Novavax is making good progress with SII backed regulatory filings. SII and the Indian government “ban” on COVID vaccine exports are a necessary vulnerability in the short term. Investors ...

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精彩评论

TradeMore
2021-11-26
TradeMore
Ohh
Boink
2021-11-26
Boink
Some say no to vax?
- Fionfion82:
  Ok
KLF
2021-11-26
KLF
Good progress
- KLF:
  hmm
- KLF:
  Omicron.....
- KLF:
  hmm
- KLF:
  hmm
- Jo_vie:
  ok
Littlenoobie
2021-11-26
Littlenoobie
Ok
RachelNg
2021-11-26
RachelNg
O
- Littlenoobie:
  Ok
- Eatmi:
  ok
- RachelNg:
  J

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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.\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.","kind":"news","is_publish_news":true,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":877105384,"gmtCreate":1637894329983,"gmtModify":1637894330094,"author":{"id":"4097720712211120","authorId":"4097720712211120","name":"TradeMore","avatar":"https://static.tigerbbs.com/976c10f5e71e9a3b002205015f764d44","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"4097720712211120","authorIdStr":"4097720712211120"},"htmlText":"Ohh","listText":"Ohh","text":"Ohh","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/877105384","repostId":1172101126,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":877100102,"gmtCreate":1637893556749,"gmtModify":1637893556893,"author":{"id":"3584620238111631","authorId":"3584620238111631","name":"Boink","avatar":"https://static.tigerbbs.com/c209643e8a7d239ba24db30470811841","vip":1,"crmLevel":4,"crmLevelSwitch":0,"idStr":"3584620238111631","authorIdStr":"3584620238111631"},"htmlText":"Some say no to vax?","listText":"Some say no to vax?","text":"Some say no to 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