Ocugen Still Lacks a Path to U.S. Profits
Any investment in Ocugen (NASDAQ:OCGN) stock is based on hope. That hope involves the FDA approving the Covid-19 vaccine known as Covaxin.
Over the last six months or so, the company has repeatedly suggested that such an approval was imminent.
On Feb. 2, Ocugen announced an agreement with the Indian drug maker Bharat Biotech. Under the deal, Ocugen would get 45% of any profits generated by the sale of Bharat’s Covaxcin vaccine in the U.S.
Two Stock Rallies
That news made Ocugen a Covid-19 stock and caused OCGN stock to soar over the span of a few days. Ocugen’s shares quickly moved from $2 to $15, cementing the firm’s place on the periphery of Covid-19 vaccine names ever since. However, the company’s share prices declined sharply in subsequent weeks.
The shares spiked again in May on news that Covaxin had shown efficacy against Covid-19 variants that had arisen in the UK, India, and Brazil. A few days later, the company announced that it was preparing to submit the necessary paperwork to the FDA to receive Emergency Use Approval for Covaxin. That plan ultimately faltered, with the FDA recommending that the company instead pursue full approval of the shot.
Early May was the last time that OCGN stock tested the $15 level. But hope springs eternal for this stock.
No Immediate Trouble
The good news for Ocugen is that it faces no immediate trouble from a financial perspective. As of June 30, the company had cash, cash equivalents, and restricted cash totaling $115.8 million. That was much more than the $24.2 million that it held on Dec. 31, 2020.
But at the same time, there’s a bigger issue: Ocugen cannot simply continue to sell its shares at high prices without showing that it can monetize its rights to Bharat’s Covaxin vaccine.
At this point, after the FDA declined to grant the EUA requested by Ocugen, it seems unlikely that the agency will grant the drug maker a license which could change its fortunes in the United States.
There is little news on Covaxin out of Canada, where Ocugen also has the rights to 45% of any profit generated by the shot. And even if a drastic change occurs on that front, investors obviously have to consider that Canada’s population is much lower than that of the U.S. In a nutshell, it’s clear that Canada’s market is nowhere near as valuable as that of the United States’.
The WHO Angle
Ocugen bulls are upbeat about a meeting of the World Health Organization, or WHO, that’s scheduled for Oct. 5.
A group called the Strategic Advisory Group of Experts on Immunization (SAGE) acts as advisors to WHO on overall global policies and strategy related to vaccines.
That group will meet on Oct. 5 and decide whether to approve Covaxin for emergency use.
But here’s the kicker: Even if that panel ultimately grants Covaxin an EUA, OCGN stock may not subsequently climb.
Remember, Ocugen has commercial rights for Covaxin only in the U.S. and Canada. There is no indication that WHO’s EUA supersedes the authority of the U.S. FDA or of its Canadian counterpart.
So even if the SAGE panel decides that Covaxin will be approved, revenues aren’t going to start flowing to Ocugen, as far as I can see.
The Bottom Line on OCGN Stock
I don’t believe that Ocugen will benefit even if the WHO’s panel approves Covaxin.
OCGN stock traded sideways all summer long. As fall begins, it’s difficult to understand why that would change.
On the date of publication, Alex Sirois 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.
