Novavax Hit Hard by Late Vaccine, while BioNTech Touts Variant-Adapted Shots

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On Monday, vaccine-focused biopharma company Novavax released its second quarter financial results, showing a dramatic adjustment in its sales outlook for the rest of the year. Instead of expecting some $4 to $5 billion in revenue, the Maryland biotech slashed its forecast in half and is now looking to make between $2 and $2.3 billion.

This shortfall is driven by the waning demand for COVID-19 shots - both domestically and internationally - and Novavax’s own shortcomings and challenges over the past two years. 

Unlike Pfizer and Moderna, which developed mRNA-based vaccines against COVID-19, Novavax created its coronavirus shot, Nuvaxovid (NVX-CoV2373), as a protein-based formulation. It uses an engineered antigen that mimics the virus’s spike protein to prime the immune system. The company was hoping to capture the market segment that was apprehensive about relatively newer vaccine platforms. 

But Novavax was very late to the game. Nuvaxovid was approved for use in adults aged 18 years or older in the United States just last month when some 70% of this population had already been vaccinated against COVID-19.

Nuvaxovid Can't Catch a Break

Novavax’s vaccine was bogged down considerably by manufacturing and safety issues. Just in the month leading up to its approval, the U.S Food and Drug Administration flagged NVX-CoV2373 after four patients developed heart inflammation following injection. Shortly after, the regulatory body said that it first needed to review changes to the company’s manufacturing process before signing off on the vaccine.

Even after approval, Nuvaxovid couldn’t seem to catch a break. Last month, the European Medicines Agency included a severe allergic reaction warning on the vaccine’s product information. The EMA approved Nuvaxovid in December 2021.

Internationally, Novavax also felt the crunch of a surplus of vaccine supply and the difficult realities of downloading these shots to low- and middle-income countries. A non-negligible part of the company’s financial woes stems from a sharp reduction in vaccine deliveries to COVAX, an international mechanism designed to ensure equitable access to the COVID-19 vaccines.

In total, sales of Nuvaxovid came in at just over $55 million this quarter, down nearly tenfold from its $585-million earnings the previous quarter. Novavax’s total revenue for the second quarter of 2022 sat at $186 million, significantly lower than the $298 million it brought in during the same quarter last year.

BioNTech Prepares to Launch Variant-Adapted Shots

While Novavax struggles with its coronavirus vaccine, German company BioNTech is hoping to deal with the declining demand by putting forward two Omicron-adapted shots.

In its own second quarter update, also published Monday, the company reported total revenue of around $3.2 billion, down approximately 40% from the same period last year. Much of BioNTech’s earnings come from its Pfizer-partnered COVID-19 vaccine Comirnaty, but as in the case of Novavax, as more people become fully vaccinated, demand - and sales - for the first-generation coronavirus shots weaken.

In the same report, BioNTech revealed that it is preparing to launch two variant-adopted bivalent shots, designed after both the original coronavirus strain and the Omicron BA.1 or BA.4/5 subvariants. These new vaccine candidates are being developed in line with recommendations from the FDA and EMA and the company expects to deliver them as early as October. 

In a display of confidence in these shots, BioNTech maintained its revenue outlook, projecting its 2022 vaccine revenue to be between approximately $13.3 and $17.4 billion.