Ocugen Bulls Are Overlooking Its FDA Approval Hurdles

One of the most important traits for any investor, business executive or marketer is the ability to identify their target audiences and see things from the latter’s point of view. I believe those who are bullish on Ocugen (NASDAQ:OCGN) stock are failing to do that. OCGN stock has made headlines thanks to the company’s Covid-19 vaccine candidate, Covaxin. But its path forward is not as easy as those of its peers.

Many companies and investors who are supposed to be brilliant have run into the same trap. For example, I remember in 2014 Marissa Mayer, who was then CEO of Yahoo!, hired Katie Couric in an effort to lift the company’s profile.

I’m sure Mayer adored Couric, but Couric’s likely target audience — millennials and Generation X –probably knew little about the former NBC morning anchor. After all, most young people at the time got their news from Facebook (NASDAQ:FB) and similar social media sites — not broadcast channels like NBC, where Couric worked for most of her career.

Similarly, Google (NASDAQ:GOOG, NASDAQ:GOOGL) spent a great deal of money on Google Glass. The device greatly impressed many techies, but failed to excite most ordinary people. Of course, the product failed miserably.

While Ocugen is in an entirely different field, they’re experiencing a similar problem and will likely face equally negative results.

Ocugen Has One Small Target Audience

One very small group of people will determine whether Ocugen will make any money from its Covaxin vaccine. I’m referring to the leadership of the U.S. Food and Drug Administration (FDA).

That’s because Ocugen has only obtained the rights to Bharat Biotech’s Covaxin vaccine in two countries — the U.S. and Canada. The latter has too few people to generate enough profits to justify the valuation of OCGN stock. And the only way that Ocugen can ever sell Covaxin in the U.S. is if the shot is approved by the FDA.

That means its top and bottom lines hinge on the FDA’s decision.

Likewise, an emergency authorization by the World Health Organization (WHO) will not increase Ocugen’s top or bottom lines by one cent. And any approval of Covaxin by countries other than the U.S. and Canada will not impact Ocugen’s financial results at all.

The FDA Seems Unlikely to Approve Covaxin

There are many signs, most of which I’ve covered in previous articles, that the agency has no interest in approving Bharat’s shot. The most prominent of these is the FDA’s denial of an emergency use authorization (EUA) to Covaxin after Ocugen applied for it last spring.

But there are others. The U.S. government agreed to buy vaccines from Novavax (NASDAQ:NVAX) and actually obtained vaccines from AstraZeneca (NASDAQ:AZN). But it never agreed to buy Covaxin or suggested it would do so. Similarly, the FDA has allowed AstraZeneca’s vaccine to be exported from the U.S., but has not taken a similar step for Covaxin.

Additionally, no one from the U.S. government has ever, as far as I know, even suggested that the FDA would consider approving Covaxin. For example, the country allows international travelers who have received the AstraZeneca vaccine to enter the U.S. However, it does not enable those who have received the Covaxin shot to do so (with the notable exception of India’s prime minister.)

Finally, as I’ve noted in many other columns, the FDA is requiring Ocugen to conduct U.S.-based tests of Covaxin before it will consider approving the shot. And yet Ocugen has still not suggested it is in any way preparing to conduct such tests.

The Most Likely Scenario for OCGN Stock

I’ve long expected the WHO to grant an emergency use authorization to Covaxin. That’s because without the EUA, the millions of Indian citizens who have received the shot cannot travel to many other countries. I have found it hard to believe the agency would prevent that number of people from traveling outside their country for  many months or years.

But on the other hand, some signs indicate the pandemic is winding down. Furthermore, the WHO has dragged out the process of granting the EUA to Covaxin. Therefore, I would not be very surprised if the agency declines to grant the EUA, forcing those who have received the Covaxin shot to wait until all travel restrictions are lifted before they can visit many countries.

But I still think there’s an 80% chance the WHO will grant the EUA sometime this month. After the approval is granted, I expect OCGN stock to climb around 10% to 20%.

In the past, Ocugen has responded to significant good news on Covaxin by selling a large amount of its shares. The WHO approval will likely be the last piece of major good news for Covaxin before the pandemic becomes fully “manageable” and much less top-of-mind for investors. Therefore, I expect Ocugen to sell a very large amount of shares, ultimately causing the stock to lose 30% to 40% over the subsequent week.

At the end of the day, Ocugen can’t make a significant amount of money without an FDA approval of Covaxin. And every sign indicates that such an approval will not be granted. Therefore, I continue to advise investors to sell or short OCGN stock.

On the date of publication, Larry Ramer was short OCGN. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Larry Ramer has conducted research and written articles on U.S. stocks for 14 years. He has been employed by The Fly and Israel’s largest business newspaper, Globes. Larry began writing columns for InvestorPlace in 2015.  Among his highly successful, contrarian picks have been GE, solar stocks, Roku, Plug Power and Snap. You can reach him on StockTwits at @larryramer.