Since the start of May, Covid-19 vaccine play Ocugen (NASDAQ:OCGN) stock is down around 50%. But the company has made some progress in bringing Covaxin, developed in India by Bharat Biotech, to the U.S. market. So, are things back on track?
Yes and no. Sure, the company now has a set date (June) for when it will submit its Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA). It’s looking more like it’ll have a marketable vaccine within the next few months.
But this still doesn’t guarantee it will receive the big financial windfall from it that’s still priced into shares. A majority of American adults are already vaccinated. A large amount of those still not vaccinated are either hesitant about, or adamantly against, getting one. This makes it questionable whether it’ll get a sufficient number of orders.
Like with Novavax (NASDAQ:NVAX), consider this another “too little, too late” vaccine play. Almost all of its value is tied to Covaxin’s perceived potential. As this perception fades, expect shares to fall back to where they were before this catalyst came about. With the risk of it eventually falling back to under $1 per share, your best move is to steer clear.
OCGN Stock and Upcoming EUA Application
Before the May 26 update, it was unclear for how long Ocugen would have to wait until it could put in its EUA request. A previous press release, which came out just days before this latest announcement, provided vague details about when exactly it was going to be ready to send in its application.
Also, changes to the FDA’s guidance on EUA submissions for Covid-19 vaccines made it questionable whether it could move ahead with its application. But as stated in the press release, Ocugen is confident it meets the criteria. This is because the recent changes apply only to spike protein-based candidates. Its candidate does not use this method, and instead combines the inactivated virus with a novel adjuvant.
In short, it’s a positive that the company has provided more details about its progress in getting EUA for Covaxin. But this is just the first step. The request still needs to be approved. As our own Larry Ramer argued on May 17, the fact this candidate has not held U.S.-based Phase-3 clinical trials could affect its chances of obtaining authorization.
Then there’s the demand issue. The company only has rights to commercialize Covaxin in the U.S. market. Unlike with Novavax, it can’t fall back on orders from overseas. With the U.S. Covid-19 vaccine market saturated, there’s likely little need for or interest in another one. Ultimately, this points to the continued breakdown of the OCGN stock bull case.
The Demand Is Still Not There for Another Vaccine
Let’s assume the company manages to get EUA for Covaxin. Can they even profit from it? There’s a reason why shares are still up 25-fold from their lows. Investors remain confident this candidate will produce a tremendous financial windfall for the company.
But like I argued in my last article on Ocugen, is the demand even there? Vaccination rates among adults in the U.S. have now hit 50%. Sure, that leaves tens of millions not vaccinated. But that’s not to say there’s enough room in the market for Covaxin. Even after widespread use of the vaccine, 70 million doses of the existing vaccines remain available.
And, don’t forget that vaccine hesitancy still runs high in the United States. 19% of respondents to a recent poll answered either “definitely not” or “only if required” when asked about their thoughts on getting a Covid-19 vaccine. Another 15% said they would “wait and see.”
In short, there’s little demand for yet another vaccine. It’s hard to see Federal or U.S. State-level health agencies rushing out to buy doses of Covaxin. This doesn’t bode well for OCGN stock, whose market capitalization today (around $1.6 billion) hinges on this vaccine being a commercial hit.
Bottom Line: OCGN Stock Has No Room to Go But Down
Ocugen may be moving ahead with its EUA application to the FDA. But it’s too early to say whether it gets authorization, much less finds enough demand in the U.S. market. As more investors realize the numbers do not add up, shares will continue trending lower from here.
How low could shares go? It’s worth considering that the company has other candidates in its pipeline. For example, it has a retinal disease gene therapy, OCU400. And, while dilutive, the capital raises the company executed earlier this year have upped its cash reserves from $24 million to $44.9 million.
But even when accounting for what it has outside its vaccine catalyst, it’s likely far from enough to prevent the stock from falling back to its pre-Covaxin-deal levels (well under $1 per share). In short, stay away from OCGN stock as it trends lower.
On the date of publication, Thomas Niel did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
Thomas Niel, contributor for InvestorPlace.com, has been writing single-stock analysis for web-based publications since 2016.
