Novavax Still Has Not Received an FDA EUA as the Market Waits

Novavax (NASDAQ:NVAX), the Gaithersburg, Maryland-based biotech company, still has not submitted its Covid-19 vaccine for emergency use approval (EUA) to the Food and Drug Administration (FDA). The company says it will do so by the end of January. But the market is skeptical and is still waiting to see when the EUA will happen. As a result, NVAX stock has been treading water.

Concept of Novavax (NVAX) vaccine against COVID-19. Glass medical vials with liquid. Ampoules with coronavirus vaccine on a medical glass table
Source: vovidzha /

For example, Novavax stock reached a near-term peak of $270.58 on Sept. 7, but it has been drifting lower ever since then. In fact, as of Jan. 13, the stock hit a new recent low of $112.37. That put it down $158.21 since its peak on Sept. 7, or down 58.4%.

That is not good.

The market is tired of waiting for the company to perform and get its revenue production in gear.

Where Things Stand Now With Novavax

For example, right now, even at today’s price its market valuation is $8.5 billion. That may still be too high even if the EUA is granted, given that at some point Covid-related revenues may not prove as long-lasting as originally forecast.

However, despite Novavax’s foot-dragging with the FDA, it has made good progress overseas. For example, on Jan. 12 Novavax received a Biologics License Application (BLA) from South Korea’s Ministry of Food and Drug Safety (MFDS).

That’s nice, but Novavax will have to compete against vaccines made by AstraZeneca (NYSE:AZN), Moderna (NASDAQ:MRNA), and Johnson & Johnson (NYSE:JNJ), through its Jansen unit. This is according to a recent report by Reuters.

Moreover, Reuters says that Novavax submitted the application to the MFDS through a partnership with a South Korean firm, SK Bioscience Co Ltd. So it will have to split the revenue, depending on how many doses the government orders, with the South Korean firm.

According to Reuters, Novavax has already received EUA for its two-dose, protein-based vaccine from both the European Union (EU) and the World Health Organization (WHO). But so far, Novavax has not booked large amounts of revenue from either approvals, although this may rise during 2022.

In addition, it has received EUA from Indonesia, in conjunction with the Serum Institute of India (SII). In addition, Novavax has submitted for EUA approval in the U.K., Australia, India, Singapore, Canada, New Zealand.

Financial Issues Are Also Keeping NVAX Stock Down

Novavax released its third-quarter financials on Nov. 4, showing that it had $179 million in sales, up from $157 million in the prior-year period. So far this year it has made less than $1 billion in sales, about $924 million.

But it has lost money in a big way. For example, it posted a net loss of $322 million, or $4.31 per share in Q3. For the nine months ending Sept. 30, it lost $897 million.

So far it can afford to lose money. As of Sept. 30, it had $1.9 billion in cash, cash equivalents, and restricted cash. But at some point in the next year, it has got to start booking large amounts of sales from its Covid-19 vaccine.

Right now analysts forecast sales in 2022 of $1.38 billion in 2021 but significantly higher for 2022 — up to $4.62 billion (Seeking Alpha and Yahoo! Finance forecasts).

But this assumes large Covid vaccine orders will come in during the year. If there is any delay with the FDA approval of its EUA, those revenue forecasts could be too high. So there is some risk here.

What To Do With NVAX Stock

That could be one reason why NVAX stock has been deteriorating. After all, at its $8.5 billion market value, if revenue falls short by even 20% next year, it will be trading at 2.3 times sales (i.e., $8.5b / $3.7b). That could be seen as too high and the NVAX stock could fall further.

However, if the company gives good forecasts for its ongoing revenue for the first quarter of 2022 then this could lead to higher overall 2022 revenue forecasts. And the stock could rebound.

On balance, I think it might be time to accumulate shares at this price. For example, some are already calling Covid-19 an “endemic” illness, comparable to the flu. This will mean there will be an ongoing demand every year for a variety of Covid-19 vaccines, including from Novavax.

That will provide a secure and robust revenue stream for Novavax for a long time. That will eventually push NVAX stock much higher.

On the date of publication, Mark R. Hake did not hold any position (either directly or indirectly) in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the Publishing Guidelines.

Mark Hake writes about personal finance on and runs the Total Yield Value Guide which you can review here.

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