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2021-11-04

very detailed and well thought analysis,superb thanks...like like...

Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors<blockquote>Ocugen：世卫组织批准科瓦克辛可能会转移投资者的注意力</blockquote>

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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":846935260,"tweetId":"846935260","gmtCreate":1636038831085,"gmtModify":1636039097935,"author":{"id":4091708143350050,"idStr":"4091708143350050","authorId":4091708143350050,"authorIdStr":"4091708143350050","name":"Likelike","avatar":"https://static.tigerbbs.com/0c535dfd23243cbd1cba5aae16cf970c","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":12,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":29,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"extraTitle":"","html":"<html><head></head><body>very detailed and well thought analysis,superb thanks...like like...</body></html>","htmlText":"<html><head></head><body>very detailed and well thought analysis,superb thanks...like like...</body></html>","text":"very detailed and well thought analysis,superb thanks...like like...","highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/846935260","repostId":1168874793,"repostType":2,"repost":{"id":"1168874793","kind":"news","pubTimestamp":1636035446,"share":"https://www.laohu8.com/m/news/1168874793?lang=zh_CN&edition=full","pubTime":"2021-11-04 22:17","market":"us","language":"en","title":"Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors<blockquote>Ocugen：世卫组织批准科瓦克辛可能会转移投资者的注意力</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1168874793","media":"Seeking Alpha","summary":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US ","content":"Summary<blockquote>总结</blockquote> <ul> <li>Ocugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.</li> <li>Meanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.</li> <li>There are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up &gt;4,000% in the past year, but has trodden water for several months.</li> <li>It's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.</li> </ul> <img src=\"https://static.tigerbbs.com/25648bf13e5cb82880f748129c72261c\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\">Klaus Vedfelt/DigitalVision via Getty Images<blockquote><ul><li>今年早些时候，Ocugen错过了在美国获得科瓦克辛紧急使用授权的机会，但它仍然可以通过一项关键的免疫桥接研究获得批准。</li><li>与此同时，Bharat已获得世卫组织紧急使用清单批准，这意味着该疫苗可以在世界各地分发，但这并没有直接使Ocugen受益。</li><li>存在多种可能性，Ocugen并不缺乏支持者和空头——该股在过去一年中上涨了4,000%以上，但几个月来一直停滞不前。</li><li>很难确定Ocugen股东接下来会发生什么，但如果我是其中之一，我会持有并抱有希望。我在下面回顾了整个故事。</li></ul>Klaus Vedfelt/DigitalVision来自Getty Images</blockquote> Investment Thesis<blockquote>投资论文</blockquote> Bharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.<blockquote>巴拉特生物技术公司今天获得世界卫生组织（“世卫组织”）的批准，加入新冠肺炎疫苗的紧急使用清单（“EUL”）。</blockquote> As most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.<blockquote>正如大多数投资者所知，Ocugen(OCGN)拥有代表Bharat在美国分销科瓦克辛的权利，以换取所有利润45%的份额。它还为加拿大制定了类似的协议，将赚取所有利润的55%。</blockquote> Ocugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.<blockquote>Ocugen投资者和空头将紧张地等待，看看今天的消息如何影响该生物技术公司的股价，该公司的股价最初跃升至16美元，但盘后已跌至12美元。</blockquote> In this post I recap the full story, updated from my&nbsp;last post in June, and offer some ways to think about Ocugen's share price in the short and long term.<blockquote>在这篇文章中，我回顾了整个故事，更新了我6月份的上一篇文章，并提供了一些从短期和长期角度思考Ocugen股价的方法。</blockquote> Ocugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far<blockquote>由于巴拉特新冠疫苗交易，Ocugen股价在3个月内从0.5美元上涨至16美元——迄今为止的故事</blockquote> Ocugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading &lt;$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").<blockquote>Ocugen是2021年更离奇的生物技术故事之一。2020年12月中旬，其股价交易价格&lt;0.5美元，因为该公司放弃了移植物抗宿主病（“GvHD”）主要候选药物OCU300的开发，难以开发针对眼病的基因治疗候选药物的临床前组合。</blockquote> A delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech&nbsp;became a partner&nbsp;of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.<blockquote>该公司可能会从纳斯达克退市，但随后Ocugen的命运发生了巨大变化——该生物技术公司成为全病毒体灭活疫苗候选物Covaxin开发商Bharat Biotech的合作伙伴，同意帮助这家印度制药公司将Covaxin商业化在美国和加拿大。一夜之间，Ocugen的股价跃升至3美元，到2月初，其交易价格为16美元。</blockquote> I covered the full story in a&nbsp;note on Ocugen&nbsp;back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.<blockquote>早在6月份，我就在一篇关于Ocugen的报告中报道了完整的故事，当时Ocugen的股价在6-10美元之间稍微实际一点的范围内交易。当时，关键问题是科瓦克辛是否会获得FDA的紧急使用授权（“EUA”），允许其在美国上市销售。</blockquote> Unfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.<blockquote>对于Ocugen投资者来说不幸的是，Bharat在印度的科瓦克辛病试验被推迟，印度的COVID疫情突然变得广泛，这意味着Ocugen无法在美国政府规定的最后期限前及时向FDA获得积极的3期试验数据——此后，对于那些尚未开始与FDA讨论的公司，它将不会接受任何进一步的EUA请求，为大流行的剩余时间提供COVID-19疫苗。</blockquote> Ocugen And Bharat Stay The Course - Trials Reveal Strong Efficacy<blockquote>Ocugen和Bharat坚持到底——试验显示出强大的功效</blockquote> The bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.<blockquote>然而，有关美国EUA的坏消息并没有阻止Ocugen、Bharat或Ocugen的投资者。尽管空头兴趣浓厚，但许多市场观察人士得出的结论是，如果科瓦克辛在美国没有EUA，Ocugen的股价将大幅下跌，Ocugen管理层认为还有其他选择，包括在加拿大获得EUA，这属于其与Bharat的协议，使Ocugen能够赚取该地区所有收入的45%。</blockquote> The results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.<blockquote>Bharat在印度的~@5k患者3期试验结果也是积极的。</blockquote> <img src=\"https://static.tigerbbs.com/862520ed53c876fb96840a3cb9a7a6f9\" tg-width=\"640\" tg-height=\"317\" width=\"100%\" height=\"auto\">Summary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.<blockquote>Bharat Biotech科瓦克辛病3期试验结果总结。资料来源：Ocugen公司介绍。</blockquote> As we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.<blockquote>正如我们在上面看到的，巴拉特的科瓦克辛（最终）提供了77.8%的功效读数，对严重疾病的功效为93.4%，对德尔塔变异毒株的功效为65.2%，这是所有新冠病毒株中最具破坏性的。此外，美国国家过敏和传染病研究所建议，在NIAID的支持下，在美国堪萨斯开发的一种新型疫苗佐剂Alhydroxiquim-II增强了科瓦克辛病的总体疗效。</blockquote> Bharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada<blockquote>Bharat寻求世界卫生组织紧急使用清单，而Ocugen则将目光投向加拿大</blockquote> These results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has&nbsp;dropped as low as 39%&nbsp;in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.<blockquote>这些结果尽管很强——应该指出的是，辉瑞(PFE)和BioNTech(BNTX)信使RNA Comirnaty疫苗针对德尔塔变异毒株病毒的功效在以色列的研究中已下降至39%——但它们来得太晚了无法帮助Ocugen在美国获得EUA。</blockquote> Ocugen turned its attention to Canada,announcing&nbsp;a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd,allowing for it to submit new data as and when it came in, accelerating the overall review process.<blockquote>Ocugen将注意力转向加拿大，于7月15日宣布通过其附属公司Vaccigen，Ltd向加拿大卫生部提交滚动申请,允许it部门在收到新数据时提交新数据，从而加快整体审查过程。</blockquote> If approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my&nbsp;last note when providing some discounted cash flow analysis&nbsp;based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.<blockquote>如果获得批准，Ocugen将获得该疫苗所有利润的55%，但正如我在上一篇笔记中讨论的那样，在提供一些基于乐观和悲观情景的贴现现金流分析时，仅加拿大政府的购买是否会提供这一结果值得怀疑。Ocugen目前的市值估值为25亿美元，股价为12.7美元。</blockquote> The US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\")&nbsp;submission&nbsp;to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:<blockquote>美国是Ocugen的关键，管理层绝不会放弃这个机会。10月下旬，Ocugen向FDA提交了研究性新药（“IND”）。Ocugen的计划是启动一项3期“免疫桥接研究”，在美国招募数百名健康成年人，他们将接受2剂科瓦克辛或安慰剂，间隔28天。管理层（在10月27日的新闻稿中）对这些终点的描述如下：</blockquote> The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population. Ocugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.<blockquote>主要终点将比较从接受科瓦克辛的美国参与者身上采集的血液样本™在印度进行的3期疗效试验的参与者样本。次要终点包括测试疫苗的免疫原性特征。该研究还将评估美国人群的安全性和耐受性。如果FDA批准，Ocugen希望在H122结束前完成这项研究，但FDA尚未做出决定。如果FDA真的开了绿灯，那么美国市场——以及Ocugen 45%的利润——就会突然回到桌面上。</blockquote> Meanwhile, Bharat Biotech&nbsp;received notification&nbsp;today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.<blockquote>与此同时，Bharat Biotech今天收到通知，世界卫生组织已批准其紧急使用清单（“EUL”）的申请，这意味着科瓦克辛现在可能会被许多外国政府接受，接种疫苗的印度人出国旅行的问题将更少。</blockquote> It's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson &amp; Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.<blockquote>这对Bharat来说是个好消息，他与辉瑞/BioNTech、强生(JNJ)、国药控股、Moderna(MRNA)和阿斯利康(AZN)等公司一起加入了EUL批准的疫苗开发商名单，但这不一定是好消息对于Ocugen来说。</blockquote> Vaccines on the EUL list are permitted to be sent to government's around the world as part of the&nbsp;COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.<blockquote>作为COVAX计划的一部分，EUL清单上的疫苗被允许发送到世界各地的政府，该计划旨在在世界各地（包括较贫穷国家）实现公平的疫苗分配，但美国是该计划的捐助者，而不是受益者，这意味着由于世卫组织批准科瓦克辛，Ocugen实际上没有获得任何好处，也没有收入。</blockquote> Ocugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA<blockquote>Ocugen股票已经处于下降趋势——现在所有人的目光都集中在加拿大卫生部和FDA身上</blockquote> Ocugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.<blockquote>Ocugen股票在今天的交易中从约9美元的价格反弹至约16美元的峰值，但股价很快开始下跌，最终收于12.7美元。盘后，股价又下跌10%。</blockquote> That reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.<blockquote>这反映出这样一个事实：世卫组织对科瓦克辛的批准对改善Ocugen自身的命运几乎没有什么作用，而且说实话，这有点转移视线。</blockquote> Ocugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.<blockquote>Ocugen投资者和Ocugen空头迫切想知道科瓦克辛在美国和加拿大的未来会怎样，但他们必须等到加拿大卫生部和FDA分别就紧急使用授权做出裁决，并批准开始在美国进行大幅减少的关键试验。</blockquote> Ironically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.<blockquote>具有讽刺意味的是，尽管有所有的新闻报道和科瓦克辛3期试验数据的公布，以及印度政府授予科瓦克辛的EUA，但Ocugen的命运与我上次报道该公司时相似——除非美国EUA的机会。</blockquote> That opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.<blockquote>这个机会——可能让Ocugen股价飙升的机会——已经过去了，但正如我在上一篇文章中所说，我认为美国可能不会反对储存一些科瓦克辛疫苗，它具有差异化的作用机制，如果储存在2-8摄氏度下，保质期可达数年。</blockquote> Covaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.<blockquote>理由可能是，科瓦克辛可能具有其他疫苗没有的好处，例如它能够诱导Th1反应，赋予细胞介导的免疫并提供持久的保护，以及增强对COVID变异的保护，这是目前主要关注的问题。</blockquote> On the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.<blockquote>另一方面，美国现在可能能够通过世卫组织直接从巴拉特获得供应，并能够将中间人Ocugen排除在任何交易之外。</blockquote> The fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.<blockquote>事实是，Ocugen与巴拉特和科瓦克辛的机会似乎总是需要权宜之计的执行，以便利用美国市场的机会，这种机会在最坏的情况下是不确定的，也许可以忽略不计，在最好的情况下是潜在的数十亿美元的机会。</blockquote> Nobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.<blockquote>没有人知道Ocugen是否有机会在美国销售科瓦克辛，但如果有机会，它将需要首先谈判一项棘手的3期试验，这可能会让我们进入明年下半年。同样，目前还没有人知道加拿大卫生部是否会批准该疫苗。</blockquote> Conclusion<blockquote>结论</blockquote> To summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?<blockquote>总结一下目前的情况，我倾向于加拿大的批准——如果科瓦克辛对世卫组织来说足够好，为什么对加拿大来说不够好呢？</blockquote> But how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.<blockquote>但是加拿大会购买多少产品呢？这可能足以导致Ocugen股票的价格大幅飙升，尽管需求不太可能高到足以长期维持这种飙升。</blockquote> How much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.<blockquote>如果科瓦克辛在美国获得批准，美国会买多少？再说一次，我认为这个交易量不足以将Ocugen的市值推高到100亿美元以上，但如果它真的购买任何股票，Ocugen的市值或多或少肯定会飙升，至少是暂时的。</blockquote> In conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.<blockquote>总之，我认为Ocugen的故事中有足够的阴谋和机会让投资者保持兴趣——无论是空头还是多头。世界卫生组织的批准并没有直接有利于Ocugen的收入，但这是科瓦克辛的又一次胜利，这反过来也是Ocugen的胜利。</blockquote> If I has been holding Ocugen stock since December last year, when it traded at &gt;$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.<blockquote>如果我自去年12月以来一直持有Ocugen股票，当时其交易价格&gt;0.5美元，坦率地说，我现在就会卖出，但如果我以约10美元的价格建仓，期望在美国批准后我的资金翻倍，我仍然会（紧张地）持有。</blockquote>","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>Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors<blockquote>Ocugen：世卫组织批准科瓦克辛可能会转移投资者的注意力</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\">\nOcugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors<blockquote>Ocugen：世卫组织批准科瓦克辛可能会转移投资者的注意力</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nSeeking Alpha2021-11-04 22:17\n\n</h4>\n</header>\n<article>\nSummary<blockquote>总结</blockquote> <ul> <li>Ocugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.</li> <li>Meanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.</li> <li>There are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up &gt;4,000% in the past year, but has trodden water for several months.</li> <li>It's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.</li> </ul> <img src=\"https://static.tigerbbs.com/25648bf13e5cb82880f748129c72261c\" tg-width=\"1536\" tg-height=\"1024\" width=\"100%\" height=\"auto\">Klaus Vedfelt/DigitalVision via Getty Images<blockquote><ul><li>今年早些时候，Ocugen错过了在美国获得科瓦克辛紧急使用授权的机会，但它仍然可以通过一项关键的免疫桥接研究获得批准。</li><li>与此同时，Bharat已获得世卫组织紧急使用清单批准，这意味着该疫苗可以在世界各地分发，但这并没有直接使Ocugen受益。</li><li>存在多种可能性，Ocugen并不缺乏支持者和空头——该股在过去一年中上涨了4,000%以上，但几个月来一直停滞不前。</li><li>很难确定Ocugen股东接下来会发生什么，但如果我是其中之一，我会持有并抱有希望。我在下面回顾了整个故事。</li></ul>Klaus Vedfelt/DigitalVision来自Getty Images</blockquote> Investment Thesis<blockquote>投资论文</blockquote> Bharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.<blockquote>巴拉特生物技术公司今天获得世界卫生组织（“世卫组织”）的批准，加入新冠肺炎疫苗的紧急使用清单（“EUL”）。</blockquote> As most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.<blockquote>正如大多数投资者所知，Ocugen(OCGN)拥有代表Bharat在美国分销科瓦克辛的权利，以换取所有利润45%的份额。它还为加拿大制定了类似的协议，将赚取所有利润的55%。</blockquote> Ocugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.<blockquote>Ocugen投资者和空头将紧张地等待，看看今天的消息如何影响该生物技术公司的股价，该公司的股价最初跃升至16美元，但盘后已跌至12美元。</blockquote> In this post I recap the full story, updated from my&nbsp;last post in June, and offer some ways to think about Ocugen's share price in the short and long term.<blockquote>在这篇文章中，我回顾了整个故事，更新了我6月份的上一篇文章，并提供了一些从短期和长期角度思考Ocugen股价的方法。</blockquote> Ocugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far<blockquote>由于巴拉特新冠疫苗交易，Ocugen股价在3个月内从0.5美元上涨至16美元——迄今为止的故事</blockquote> Ocugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading &lt;$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").<blockquote>Ocugen是2021年更离奇的生物技术故事之一。2020年12月中旬，其股价交易价格&lt;0.5美元，因为该公司放弃了移植物抗宿主病（“GvHD”）主要候选药物OCU300的开发，难以开发针对眼病的基因治疗候选药物的临床前组合。</blockquote> A delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech&nbsp;became a partner&nbsp;of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.<blockquote>该公司可能会从纳斯达克退市，但随后Ocugen的命运发生了巨大变化——该生物技术公司成为全病毒体灭活疫苗候选物Covaxin开发商Bharat Biotech的合作伙伴，同意帮助这家印度制药公司将Covaxin商业化在美国和加拿大。一夜之间，Ocugen的股价跃升至3美元，到2月初，其交易价格为16美元。</blockquote> I covered the full story in a&nbsp;note on Ocugen&nbsp;back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.<blockquote>早在6月份，我就在一篇关于Ocugen的报告中报道了完整的故事，当时Ocugen的股价在6-10美元之间稍微实际一点的范围内交易。当时，关键问题是科瓦克辛是否会获得FDA的紧急使用授权（“EUA”），允许其在美国上市销售。</blockquote> Unfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.<blockquote>对于Ocugen投资者来说不幸的是，Bharat在印度的科瓦克辛病试验被推迟，印度的COVID疫情突然变得广泛，这意味着Ocugen无法在美国政府规定的最后期限前及时向FDA获得积极的3期试验数据——此后，对于那些尚未开始与FDA讨论的公司，它将不会接受任何进一步的EUA请求，为大流行的剩余时间提供COVID-19疫苗。</blockquote> Ocugen And Bharat Stay The Course - Trials Reveal Strong Efficacy<blockquote>Ocugen和Bharat坚持到底——试验显示出强大的功效</blockquote> The bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.<blockquote>然而，有关美国EUA的坏消息并没有阻止Ocugen、Bharat或Ocugen的投资者。尽管空头兴趣浓厚，但许多市场观察人士得出的结论是，如果科瓦克辛在美国没有EUA，Ocugen的股价将大幅下跌，Ocugen管理层认为还有其他选择，包括在加拿大获得EUA，这属于其与Bharat的协议，使Ocugen能够赚取该地区所有收入的45%。</blockquote> The results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.<blockquote>Bharat在印度的~@5k患者3期试验结果也是积极的。</blockquote> <img src=\"https://static.tigerbbs.com/862520ed53c876fb96840a3cb9a7a6f9\" tg-width=\"640\" tg-height=\"317\" width=\"100%\" height=\"auto\">Summary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.<blockquote>Bharat Biotech科瓦克辛病3期试验结果总结。资料来源：Ocugen公司介绍。</blockquote> As we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.<blockquote>正如我们在上面看到的，巴拉特的科瓦克辛（最终）提供了77.8%的功效读数，对严重疾病的功效为93.4%，对德尔塔变异毒株的功效为65.2%，这是所有新冠病毒株中最具破坏性的。此外，美国国家过敏和传染病研究所建议，在NIAID的支持下，在美国堪萨斯开发的一种新型疫苗佐剂Alhydroxiquim-II增强了科瓦克辛病的总体疗效。</blockquote> Bharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada<blockquote>Bharat寻求世界卫生组织紧急使用清单，而Ocugen则将目光投向加拿大</blockquote> These results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has&nbsp;dropped as low as 39%&nbsp;in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.<blockquote>这些结果尽管很强——应该指出的是，辉瑞(PFE)和BioNTech(BNTX)信使RNA Comirnaty疫苗针对德尔塔变异毒株病毒的功效在以色列的研究中已下降至39%——但它们来得太晚了无法帮助Ocugen在美国获得EUA。</blockquote> Ocugen turned its attention to Canada,announcing&nbsp;a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd,allowing for it to submit new data as and when it came in, accelerating the overall review process.<blockquote>Ocugen将注意力转向加拿大，于7月15日宣布通过其附属公司Vaccigen，Ltd向加拿大卫生部提交滚动申请,允许it部门在收到新数据时提交新数据，从而加快整体审查过程。</blockquote> If approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my&nbsp;last note when providing some discounted cash flow analysis&nbsp;based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.<blockquote>如果获得批准，Ocugen将获得该疫苗所有利润的55%，但正如我在上一篇笔记中讨论的那样，在提供一些基于乐观和悲观情景的贴现现金流分析时，仅加拿大政府的购买是否会提供这一结果值得怀疑。Ocugen目前的市值估值为25亿美元，股价为12.7美元。</blockquote> The US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\")&nbsp;submission&nbsp;to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:<blockquote>美国是Ocugen的关键，管理层绝不会放弃这个机会。10月下旬，Ocugen向FDA提交了研究性新药（“IND”）。Ocugen的计划是启动一项3期“免疫桥接研究”，在美国招募数百名健康成年人，他们将接受2剂科瓦克辛或安慰剂，间隔28天。管理层（在10月27日的新闻稿中）对这些终点的描述如下：</blockquote> The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population. Ocugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.<blockquote>主要终点将比较从接受科瓦克辛的美国参与者身上采集的血液样本™在印度进行的3期疗效试验的参与者样本。次要终点包括测试疫苗的免疫原性特征。该研究还将评估美国人群的安全性和耐受性。如果FDA批准，Ocugen希望在H122结束前完成这项研究，但FDA尚未做出决定。如果FDA真的开了绿灯，那么美国市场——以及Ocugen 45%的利润——就会突然回到桌面上。</blockquote> Meanwhile, Bharat Biotech&nbsp;received notification&nbsp;today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.<blockquote>与此同时，Bharat Biotech今天收到通知，世界卫生组织已批准其紧急使用清单（“EUL”）的申请，这意味着科瓦克辛现在可能会被许多外国政府接受，接种疫苗的印度人出国旅行的问题将更少。</blockquote> It's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson &amp; Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.<blockquote>这对Bharat来说是个好消息，他与辉瑞/BioNTech、强生(JNJ)、国药控股、Moderna(MRNA)和阿斯利康(AZN)等公司一起加入了EUL批准的疫苗开发商名单，但这不一定是好消息对于Ocugen来说。</blockquote> Vaccines on the EUL list are permitted to be sent to government's around the world as part of the&nbsp;COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.<blockquote>作为COVAX计划的一部分，EUL清单上的疫苗被允许发送到世界各地的政府，该计划旨在在世界各地（包括较贫穷国家）实现公平的疫苗分配，但美国是该计划的捐助者，而不是受益者，这意味着由于世卫组织批准科瓦克辛，Ocugen实际上没有获得任何好处，也没有收入。</blockquote> Ocugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA<blockquote>Ocugen股票已经处于下降趋势——现在所有人的目光都集中在加拿大卫生部和FDA身上</blockquote> Ocugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.<blockquote>Ocugen股票在今天的交易中从约9美元的价格反弹至约16美元的峰值，但股价很快开始下跌，最终收于12.7美元。盘后，股价又下跌10%。</blockquote> That reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.<blockquote>这反映出这样一个事实：世卫组织对科瓦克辛的批准对改善Ocugen自身的命运几乎没有什么作用，而且说实话，这有点转移视线。</blockquote> Ocugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.<blockquote>Ocugen投资者和Ocugen空头迫切想知道科瓦克辛在美国和加拿大的未来会怎样，但他们必须等到加拿大卫生部和FDA分别就紧急使用授权做出裁决，并批准开始在美国进行大幅减少的关键试验。</blockquote> Ironically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.<blockquote>具有讽刺意味的是，尽管有所有的新闻报道和科瓦克辛3期试验数据的公布，以及印度政府授予科瓦克辛的EUA，但Ocugen的命运与我上次报道该公司时相似——除非美国EUA的机会。</blockquote> That opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.<blockquote>这个机会——可能让Ocugen股价飙升的机会——已经过去了，但正如我在上一篇文章中所说，我认为美国可能不会反对储存一些科瓦克辛疫苗，它具有差异化的作用机制，如果储存在2-8摄氏度下，保质期可达数年。</blockquote> Covaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.<blockquote>理由可能是，科瓦克辛可能具有其他疫苗没有的好处，例如它能够诱导Th1反应，赋予细胞介导的免疫并提供持久的保护，以及增强对COVID变异的保护，这是目前主要关注的问题。</blockquote> On the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.<blockquote>另一方面，美国现在可能能够通过世卫组织直接从巴拉特获得供应，并能够将中间人Ocugen排除在任何交易之外。</blockquote> The fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.<blockquote>事实是，Ocugen与巴拉特和科瓦克辛的机会似乎总是需要权宜之计的执行，以便利用美国市场的机会，这种机会在最坏的情况下是不确定的，也许可以忽略不计，在最好的情况下是潜在的数十亿美元的机会。</blockquote> Nobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.<blockquote>没有人知道Ocugen是否有机会在美国销售科瓦克辛，但如果有机会，它将需要首先谈判一项棘手的3期试验，这可能会让我们进入明年下半年。同样，目前还没有人知道加拿大卫生部是否会批准该疫苗。</blockquote> Conclusion<blockquote>结论</blockquote> To summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?<blockquote>总结一下目前的情况，我倾向于加拿大的批准——如果科瓦克辛对世卫组织来说足够好，为什么对加拿大来说不够好呢？</blockquote> But how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.<blockquote>但是加拿大会购买多少产品呢？这可能足以导致Ocugen股票的价格大幅飙升，尽管需求不太可能高到足以长期维持这种飙升。</blockquote> How much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.<blockquote>如果科瓦克辛在美国获得批准，美国会买多少？再说一次，我认为这个交易量不足以将Ocugen的市值推高到100亿美元以上，但如果它真的购买任何股票，Ocugen的市值或多或少肯定会飙升，至少是暂时的。</blockquote> In conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.<blockquote>总之，我认为Ocugen的故事中有足够的阴谋和机会让投资者保持兴趣——无论是空头还是多头。世界卫生组织的批准并没有直接有利于Ocugen的收入，但这是科瓦克辛的又一次胜利，这反过来也是Ocugen的胜利。</blockquote> If I has been holding Ocugen stock since December last year, when it traded at &gt;$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.<blockquote>如果我自去年12月以来一直持有Ocugen股票，当时其交易价格&gt;0.5美元，坦率地说，我现在就会卖出，但如果我以约10美元的价格建仓，期望在美国批准后我的资金翻倍，我仍然会（紧张地）持有。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors\">Seeking Alpha</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"source_url":"https://seekingalpha.com/article/4465154-ocugen-approval-for-covaxin-red-herring-for-investors","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1168874793","content_text":"Summary\n\nOcugen missed the opportunity to grab an Emergency Use Authorization for Covaxin in the US earlier this year, but it could still gain an approval via a pivotal immuno-bridging study.\nMeanwhile, Bharat has received WHO approval for Emergency Use Listing, meaning the vaccine can be distributed around the world - but that doesn't directly benefit Ocugen.\nThere are numerous possibilities in play, and Ocugen has no shortage of backers and shorts - the stock is up >4,000% in the past year, but has trodden water for several months.\nIt's hard to determine what may be in store next for Ocugen shareholders, but if I were one, I'd be holding and hoping. I recap the full story below.\n\nKlaus Vedfelt/DigitalVision via Getty Images\nInvestment Thesis\nBharat Biotech received an approval from the World Health Organization (\"WHO\") today to join the Emergency Use List (\"EUL\") for vaccines against COVID-19.\nAs most investors will know, Ocugen (OCGN) holds the rights to distribute Covaxin in the US on behalf of Bharat, in exchange for a 45% share of all profits. It also has a similar deal in place for Canada, standing to earn 55% of all profits.\nOcugen investors and shorts will be nervously waiting to see how today's news affects the biotech's share price, which initially jumped to $16, but has fallen to $12 post-market.\nIn this post I recap the full story, updated from my last post in June, and offer some ways to think about Ocugen's share price in the short and long term.\nOcugen Stock Jumps From $0.5 To $16 In 3 Months On Bharat COVID Vaccine Deal - The Story So Far\nOcugen is one of the more bizarre biotech stories of 2021. In mid-December 2020, its shares were trading <$0.5, as the company struggled to develop a preclinical portfolio of gene therapy drug candidates targeting eye disease, having abandoned development of its lead candidate OCU300 in Graft vs Host Disease (\"GvHD\").\nA delisting from the Nasdaq looked a likely outcome for the company, but then Ocugen's fortunes changed dramatically - the biotech became a partner of Bharat Biotech, developer of the whole-virion inactivated vaccine candidate Covaxin, agreeing to help the Indian Pharma commercialise Covaxin in the US and Canada. Overnight, Ocugen's share price jumped to a price of $3, and by early February, it was trading at $16.\nI covered the full story in a note on Ocugen back in June, when Ocugen's shares were trading in a slightly more down-to-earth range of $6 - $10. At that time, the key question was whether Covaxin would receive an Emergency Use Authorization (\"EUA\") from the FDA, allowing it to be marketed and sold in the US.\nUnfortunately for Ocugen investors, delays in Bharat's trials of Covaxin in India, where outbreaks of COVID had suddenly become widespread, meant that Ocugen could not get positive Phase 3 trial data in front of the FDA in time for a deadline imposed by the US government - after which it would not accept any further EUA requests for COVID-19 vaccines for the remainder of the pandemic for those companies that have not already begun discussions with the FDA.\nOcugen And Bharat Stay The Course - Trials Reveal Strong Efficacy\nThe bad news about an EUA in the US did not deter Ocugen, Bharat, or Ocugen's investors, however. Despite heavy short interest, as many market watchers concluded Ocugen's share price would be decimated without an EUA for Covaxin in the US, Ocugen management felt that there were other options on the table, including obtaining an EUA in Canada, which falls under its agreement with Bharat, allowing Ocugen to earn 45% of all revenues earned in the region.\nThe results of Bharat's ~@5k patient Phase 3 trial in India also came out positive.\nSummary of results of Bharat Biotech Phase 3 trial of Covaxin. Source: Ocugen Corporate Presentation.\nAs we can see above, Bharat's Covaxin (finally) delivered an efficacy readout of 77.8%, 93.4% efficacy against severe disease - and 65.2% efficacy against the delta variant - the most devastating of all the COVID strains. Furthermore, the National Institute of Allergies and Infectious Diseases advised that a novel vaccine adjuvant developed in Kansas, US with NIAID support, Alhydroxiquim-II, enhanced the overall efficacy of Covaxin.\nBharat Pursues WHO Emergency Use Listing Whilst Ocugen Looks To Canada\nThese results, as strong as they are - and it should be noted the efficacy of Pfizer (PFE) and BioNTech's (BNTX) messenger-RNA Comirnaty vaccine against the Delta variant has dropped as low as 39% in studies in Israel - they arrived too late to help Ocugen secure an EUA in the US.\nOcugen turned its attention to Canada,announcing a rolling submission to Health Canada on July 15 through its affiliate, Vaccigen, Ltd,allowing for it to submit new data as and when it came in, accelerating the overall review process.\nIf approved, Ocugen will earn 55% of all profits earned from the vaccine, but as I discussed in my last note when providing some discounted cash flow analysis based on optimistic and pessimistic scenarios, it's doubtful if the Canadian government's purchases alone would provide a significant boot to Ocugen's current market cap valuation of $2.5bn, or its share price of $12.7.\nThe US is the key for Ocugen, and management has by no means given up on this opportunity. In late October, Ocugen made an Investigational New Drug (\"IND\") submission to the FDA. Ocugen's plan is to initiate a Phase 3 \"immuno-bridging study,\" enrolling several hundred healthy adults in the U.S, who will receive 2 doses of Covaxin or placebo, 28 days apart. The endpoints are described by management (in an October 27th press release) as follows:\n\n The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine's immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population.\n\nOcugen hopes to have the study complete before the end of H122, if it is approved by the FDA, which has yet to make a decision. If the FDA does give the green light, then the US market - and Ocugen's 45% of all profits - is suddenly back on the table.\nMeanwhile, Bharat Biotech received notification today that the World Health Organization has approved its application for an Emergency Use Listing (\"EUL\"), meaning Covaxin will now likely be accepted by a host of foreign governments, and that Indians who have received the vaccine will have fewer problems traveling overseas.\nIt's great news for Bharat, who join the likes of Pfizer / BioNTech, Johnson & Johnson (JNJ), SinoPharm, Moderna (MRNA) and AstraZeneca (AZN) on the list of EUL-approved vaccine developers - but it is not necessarily great news for Ocugen.\nVaccines on the EUL list are permitted to be sent to government's around the world as part of the COVAX scheme, designed to create equitable vaccine distribution around the world, including poorer countries, but the US is a donor to this scheme, not a beneficiary, meaning that Ocugen effectively gets no benefit, and no revenues, as a result of the WHO approval for Covaxin.\nOcugen Stock Is Already On A Downtrend - All Eyes Will Now Be On Health Canada And The FDA\nOcugen stock bounced from a price of ~$9, to a peak of ~$16 in trading today, however the share price quickly began to decline, and finished at a price of $12.7. Post-market, shares were down another 10%.\nThat reflects the fact that the WHO approval for Covaxin does little to improve Ocugen's own fortunes, and in all honesty, was something of a red herring.\nOcugen investors, and Ocugen shorts, are desperate to know what the future holds for Covaxin in the US and Canada, but they will have to wait until Health Canada and the FDA rule respectively on an Emergency Use Authorization, and an approval to begin a drastically reduced pivotal trial in the US.\nIronically, despite all of the news flow and the publication of Covaxin Phase 3 trial data, and the EUA granted to Covaxin by the Indian government, Ocugen's fortunes are in a similar place to where they were when I last covered the company - barring the US EUA opportunity.\nThat opportunity - the one that may have sent Ocugen shares through the roof - has gone, but as I argued in my last post, I think it's possible that the US would not object to stockpiling some of the Covaxin shot, which has a differentiated mechanism of action, and a shelf life of up to years if stored at 2- 8 degrees centigrade.\nCovaxin may have benefits that other vaccines do not, the reasoning may go, such as its ability to induce a Th1 response, conferring cell-mediated immunity and offering durable protection, and enhanced protection against COVID variants, which is the primary concern at the present time.\nOn the other hand, the US may now be able to obtain supply directly from Bharat via the WHO and be in a position to cut Ocugen - the middleman - out of any deal.\nThe fact of the matter is that Ocugen's opportunity with Bharat and Covaxin has always appeared to be one that required expediency of execution, in order to capitalize on a US market opportunity that's uncertain, perhaps negligible, at worst, and a potential multi-billion opportunity at best.\nNobody knows even if Ocugen will get an opportunity to market Covaxin in the US, but if it does, it will need to negotiate a tricky Phase 3 trial first, which could take us into the latter half of next year. Equally, no-one yet knows if Health Canada will approve the vaccine.\nConclusion\nTo summarise the current state of affairs, I would lean toward an approval in Canada - if Covaxin is good enough for the WHO, why would it not be good enough for Canada?\nBut how much product will Canada buy? Probably enough to create a substantial price spike for Ocugen stock, although demand is unlikely to be high enough to sustain that spike long term.\nHow much would the US buy if Covaxin was approved in the US? Again, I cannot see it being a high enough volume to catapult Ocugen's market cap above say $10bn, but if it buys any at all, Ocugen's market valuation is more or less guaranteed to surge, at least temporarily.\nIn conclusion, I would argue that there is enough intrigue and opportunity in the Ocugen story to keep investors interested - on both the short and long sides. The WHO approval does not directly benefit Ocugen revenues wise, but it's another win for Covaxin, which is in turn a win for Ocugen.\nIf I has been holding Ocugen stock since December last year, when it traded at >$0.5, frankly I would have sold by now, but if I had opened a position at ~$10, in expectation of doubling my money on a US approval, I would still be (nervously) holding.","news_type":1,"symbols_score_info":{"OCGN":0.9}},"isVote":1,"tweetType":1,"viewCount":3783,"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":61,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/846935260"}