Just four months ago, Ocugen (OCGN -5.60%) shares were worth pennies and its market value totaled $49 million. Earlier in 2020, the company specializing in gene therapy for eye diseases had announced the failure of a phase 3 candidate. Other candidates hadn't yet reached clinical trials. That meant the possibility of a commercialized product would be years away.
And then the tide turned. Ocugen partnered with India's Bharat Biotech on Covaxin, an investigational coronavirus vaccine. The deal gave Ocugen the right to co-commercialize Covaxin in the U.S. -- if authorized or approved -- and keep 45% of the profits.
As a result, the shares soared. Now the question is whether this highflier can keep flying -- and whether it can put millions in your pocket.
Image source: Getty Images.
Covaxin results
First, let's take a look at Covaxin's chances of taking share in the U.S. market. Bharat is testing the potential product in a phase 3 trial in India. The company reported a first round of data from that study involving more than 25,000 participants.
It showed Covaxin is 81% effective after the second dose, and the data indicated efficacy against the U.K. strain. Also, use of Covaxin results in immune responses against many viral antigens, which bodes well for efficacy against future strains of concern.
Bharat generated these results after 43 coronavirus cases accrued in the trial -- 36 in the placebo group and seven in the Covaxin group. The company plans on gathering more results at 87 cases and 130 cases.
India already granted Covaxin emergency authorization. Now, Ocugen hopes to gain the same in the U.S. The company said it's in discussions with the U.S. Food and Drug Administration (FDA) "to develop the regulatory pathway" to Emergency Use Authorization (EUA).
Let's consider a couple of scenarios. Let's imagine the FDA bases its EUA decision on the phase 3 trial in India. In that case, Covaxin would enter the U.S. market sooner instead of later. The problem here is the U.S. already has more-than-enough vaccine to cover the entire population. So it would be difficult for Covaxin to carve out market share in the near term.
Now let's imagine the FDA requires a U.S. trial prior to granting an EUA. That could extend Covaxin's timeline to commercialization by many months. Will Covaxin have a better chance at U.S. market share at that later point? Only if it stands out in some way.
So far, the more than 94% efficacy of current leaders Moderna and Pfizer surpasses that of Covaxin. The Moderna and Pfizer vaccines also are handling different strains and the companies are testing potential boosters.
These leaders also have launched clinical trials of their vaccines in kids and teens. Bharat is aiming for a phase 3 pediatric and teen trial in India but is waiting for the green light.
In either case -- an EUA sooner or later -- Covaxin will face tough competition.
Share price and market value
Ocugen's shares and market value have soared more than 1,000% and 2,000%, respectively, in the past four months on optimism about Covaxin.
The stock may move higher from here. But considering the two scenarios I've described above, I'm not convinced it should. It's wise of Ocugen to try to bring a product to market via a partnership. That could bring in revenue as it develops earlier-stage candidates. But the share gains we've already seen price this in -- unless future data reports show that Covaxin stands out from rivals in some significant way.
Will this stock make you a millionaire? If you invest $10,000 in Ocugen at today's share price of $6.50, you'll get about 1,538 shares. If Ocugen returns to its 2021 high of about $16, the value of your investment will total more than $24,600. And if Ocugen turns out to be a 10-bagger from today's price, gaining 1,000%, your investment will reach more than $99,900. These scenarios are great -- but they still haven't made you a millionaire.
At this point, you would have to make a massive investment in Ocugen to possibly become a millionaire, and that would be a very risky move. Right now, the best move may be to watch Ocugen from the sidelines -- and keep an eye out for Covaxin's next data report.
