Ocugen: WHO Approval For Covaxin Is Potentially A Red Herring For Investors

Seeking Alpha2021-11-04

Summary 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. ...

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精彩评论

MasterDrive
2021-11-05
MasterDrive
this is the reason why it dumped
Likelike
2021-11-04
Likelike
very detailed and well thought analysis,superb thanks...like like...
MuffinsDaddy
2021-11-04
MuffinsDaddy
Ol
- MuffinsDaddy:
  ok
Kave
2021-11-04
Kave
[开心] [开心]
PCQ
2021-11-04
PCQ
interesting
- D199991D:
  Yup
- Kave:
  [开心] [开心]
iamjingxian
2021-11-04
iamjingxian
Cool
- iamjingxian:
  Cool

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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.","kind":null,"is_publish_news":true,"is_publish_highlight":true,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":846974760,"gmtCreate":1636043917939,"gmtModify":1636043918042,"author":{"id":"4095811186634540","authorId":"4095811186634540","name":"MasterDrive","avatar":"https://static.tigerbbs.com/9526a906e038fe8dcae56c55dd142302","vip":1,"crmLevel":1,"crmLevelSwitch":0},"htmlText":"this is the reason why it dumped","listText":"this is the reason why it dumped","text":"this is the reason why it dumped","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/846974760","repostId":1168874793,"repostType":2,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":846935260,"gmtCreate":1636038831085,"gmtModify":1636039097935,"author":{"id":"4091708143350050","authorId":"4091708143350050","name":"Likelike","avatar":"https://static.tigerbbs.com/0c535dfd23243cbd1cba5aae16cf970c","vip":1,"crmLevel":2,"crmLevelSwitch":0},"htmlText":"very detailed and well thought analysis,superb thanks...like like...","listText":"very detailed and well thought analysis,superb thanks...like like...","text":"very detailed and well thought analysis,superb thanks...like 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