But I still believe that that anyone holding onto the shares should sell them, while risk-tolerant investors who have already shorted the stock should hold onto their positions. (Those who are very risk-tolerant may want to consider “doubling down” on their small short positions at the stock’s current levels).
Meanwhile, I recommend that risk-tolerant investors who haven’t already shorted the name devote a small portion of their portfolios to doing so.
On a high level, there are two main reasons for my stance. First, Ocugen reminds me very much of a few other once-high-flying Covid-19-oriented names that eventually crashed and burned. Specifically, like XpresSpa (NASDAQ:XSPA), Co-Diagnostics (NASDAQ:CODX), and Inovio (NASDAQ:INO), Ocugen had very little revenue before Covid-19, and its shares spiked tremendously after it unveiled its supposed Covid-19 remedy. Also like XpresSpa and Inovio, Ocugen has sold a large amount of stock after announcing its Covid-19 remedy, and I was never very convinced that its remedy would have nearly as much of an effect on the coronavirus as its backers thought. (Co-Diagnostics did not sell a large amount of stock, but two of its board members did so.)
Second, there are many signs that the FDA has no intention of approving Bharat Biotech’s coronavirus vaccine. Ocugen is slated to receive 45% of many U.S. profits from that vaccine, which is called Covaxin. Here are four of the most prominent signs that Covaxin will not be approved in the U.S.
The Covaxin Trial Doesn’t Appear to Meet the FDA’s Basic Requirements and Preferences
Healthline indicated that the FDA has said that Phase-3 trials of vaccines for the coronavirus must “include 30,000 or more participants.” And experts previously urged the agency to impose the 30,000 participant floor.
Yet on April 21, Bharat reported that its Phase-3 trial had enrolled “25,800 participants between 18-98 years of age.” That’s well under the FDA’s minimum level.
Further, there is reason to believe that the agency prefers that companies conduct at least a portion of their Phase-3 trials in America. A portion of the Phase-3 trials for each of the three vaccines already approved in the U.S. were indeed conducted in America. Given current travel restrictions and the agency’s expressed desire to generally conduct “on-site inspections of both clinical and nonclinical studies performed to support research and marketing applications/submissions to the agency,” that makes a great deal of sense.
Yet according to an FDA document, Bharat’s Phase-3 trial was conducted only in India.
Washington’s Lack of Positive Comments About Covaxin
After performing a great deal of research, I could find no upbeat comments, either on or off the record, from Washington about utilizing Covaxin in the U.S.
A recent statement by Dr. Anthony Fauci in which he uttered the word “Covaxin” caused much excitement among OCGN stock bulls. But it’s clear from the full context of Fauci’s comments that he was referring to the use of Covaxin in India.
Meanwhile, on NIH’s website, under the heading “Vaccines in Phase 3 Clinical Trials,” two companies with jabs that have not yet been approved — AstraZeneca (NASDAQ:AZN) and Novavax (NASDAQ:NVAX) — are listed, but there is no mention of either Ocugen or Bharat.
A Lack of Positive Specific Comments by Ocugen About the Approval Process
To the best of my knowledge, Ocugen has not made any specific, positive, substantive comments regarding any of its meeting with the FDA or the agency’s views on Covaxin.
During a March interview with Reuters, likely responding to a question about the FDA’s view on Bharat’s Phase-3 clinical trial, Ocugen CEO Shankar Musunuri did not sound very upbeat and did not seem to elaborate much. Musunuri said that the FDA is “fine with the way the interim analysis is being done,” and that that Ocugen has “a regulatory path” for the approval process.
Additionally, on April 23, identifying myself as a columnist for InvestorPlace, I sent the CEO the following questions on Microsoft’s (NASDAQ:MSFT) LinkedIn:
“I was wondering if you’ve had any feedback from the FDA on the vaccine and if so what the feedback has been. Also, do you intend to meet with the agency anytime soon, and when do you think the shot could become available in the U.S?”
Musunuri did not respond to my message.
Meanwhile, Novavax’s CEO, Stanley Erck, provided detailed information on the FDA’s timeline for approving the company’s vaccine. Additionally, as CNBC reported in March, “Novavax has a deal with the U.S. government to supply 110 million doses.” I don’t believe that Ocugen has made a similar deal.
A Solution to a Problem That Doesn’t Appear to Exist
Ocugen and those who are bullish on OCGN stock have made much of the efficacy of Bharat’s shot against new strains of the coronavirus. But vaccines already approved in the U.S. apparently work to some extent against different strains.
Indeed, multiple data points show that the jabs already approved by the FDA are, in general, working well. For example, in Israel, which has vaccinated the majority of its population with Pfizer’s (NYSE:PFE) shot, in in all but one day since April 28, there have been well under 100 new coronavirus cases per day and only 1-3 deaths from the coronavirus per day. (Israel has a population of well over 9 million people, and is a very densely populated nation.)
There are signs, thankfully, that the U.S. is trending in the same direction. On Tuesday, May 4, 14 states reported zero deaths, and ten reported five or fewer deaths. For the first time since early October, the average number of new cases nationwide is trending below 50,000.
On Monday, May 3, speaking on Bloomberg TV, Dr. Steven Corwin, the CEO of New York Presbyterian Hospital, said, “We’ve not seen people admitted to the hospital who’ve been vaccinated twice.” So it’s not surprising that U.S. Covid-19 hospitalizations recently started trending sharply downward.
The Bottom Line on OCGN Stock
I think that Bharat’s vaccine is highly effective and will work quite well in India and many other nations. I believe, however, that it’s clear that the shot will not be widely used in the U.S.
And since Ocugen cannot profit meaningfully from its deal with Bharat unless the shot is widely used in the U.S. and OCGN stock has soared solely based on its deal with Bharat, I think that the shares present a great shorting opportunity.
On the date of publication, Larry Ramer held a short position in OCGN.
Larry Ramer has conducted research and written articles on U.S. stocks for 13 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, and Snap. You can reach him on StockTwits at @larryramer.