Novavax, Inc. (NASDAQ:NVAX) reported a loss of $6.53 per share in the second quarter, falling short of the Zacks Consensus Estimate of earnings of $5.51. Novavax reported a $4.75 per share loss in the prior quarter.
The quarter’s revenues were $185.9 million, a 37.6% decrease from the prior year. The $1.04 billion Zacks Consensus Estimate for revenues was not met.
Novavax Detailed Q2 Results
Novavax’s protein-based COVID-19 vaccine, NVX-CoV2373, brought in $55.5 million in product sales during the second quarter. The company did not report any product sales in the previous quarter. Quarter over quarter, the sales figure decreased 90.5% sequentially. Due to timing issues with shipments of COVID vaccine doses to Europe and difficulties the COVAX plant had in distributing COVID-19 vaccine doses to low- and middle-income nations, there was a considerable fall in sales.
Novavax reported $22.7 million in revenue from the sale of adjuvants and royalties to licensees.
In the same period when Novavax materially finished the tasks necessary to fulfil the obligations under the agreements with the U.S. Government, the company’s grant revenues decreased by 60.4% year over year to $107.8 million.
Research and development costs fell 49.2% year over year to $289.6 million in the reported quarter. Lower clinical development activities for NVX-CoV2373 and lower manufacturing expenses for the vaccine incurred during the quarter were responsible for this drop.
Selling, general, and administration costs reached $108.2 million, up 47.8% from the previous year. The operations to support the commercial launch of NVX-CoV2373 caused an increase in costs.
Novavax had $1.4 billion in cash and cash equivalents as of June 30, 2022, down from $1.6 billion as of March 31, 2022.
Novavax Lowered its 2022 Guidance
For the entire year, Novavax decreased its forecast for overall revenue. Instead of the previously anticipated forecast of $4 billion to $5 billion, it expects total revenues of between $2 billion and $2.3 billion. According to management, the revised guideline considers the shifting market conditions.
On August 8, shares of Novavax fell 31% in after-hours trading, most likely due to the company’s decision to cut its entire sales projection in half. This fall was probably partly influenced by the company’s disclosure of poorer-than-expected profit results. The stock has lost 60% of its value this year, while the industry has lost 18%.
COVID-19’s Vaccine Update
Overall, 43 nations have consented for people to receive the company’s COVID vaccine as part of a primary two-dose regimen. According to NVAX, its COVID-19 vaccine has been distributed in approximately 73 million doses as of August 8. The business obtains permission to use its COVID-19 vaccine in more nations and for more patient populations.
NVX-CoV2373 is now approved for usage in Japan, Australia, and New Zealand as a booster dose. Teenagers (ages 12 to 17) in the European Union, India, Japan, Australia, and Thailand are eligible for the vaccination. Regulatory applications for these label expansions have already been submitted or are being reviewed in other nations.
The FDA granted Novavax emergency use authority (EUA) for their COVID vaccination as a primary two-dose regimen in adults in July 2022, which had been long anticipated. Additionally, the business has a contract with the U.S. government to provide 3.2 million doses of its COVID-19 protein vaccine.
In addition, the vaccine is being evaluated by Novavax in other studies. The company began phase IIb/III Hummingbird research earlier this month to test a primary two-dose regimen of its COVID vaccine in younger children between the ages of 6 months and 11 years. The first results from this study are anticipated in the first quarter of 2023. In current research on teenagers, NVAX just finished administering a booster dose of NVX-CoV2373.
In the third quarter of 2022, topline results from clinical studies evaluating its booster vaccine tailored to Omicron are anticipated. In the fourth quarter of 2022, the business plans to submit a regulatory application to the FDA for this candidate.
A COVID-19-influenza combination (CIC) vaccine candidate is also being assessed by NVAX in phase I/II research. In a single formulation, NVX-CoV2373 and NanoFlu make up the CIC vaccine. This study’s preliminary results, which showed the CIC vaccine to be workable and immunogenic, were first released by Novavax in April. The immunological reactions matched those of standalone NanoFlu and NVX-CoV2373 formulations. In the upcoming year, NVAX anticipates starting a phase III trial to gauge the effectiveness of this vaccine.
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