We expect investors to focus on the sales performance ofNovavax’s NVAX protein-based COVID-19 vaccine, its sole marketed product, when it reports second-quarter 2022 results.
In the year so far, shares of Novavax have plunged 60.6% compared with the industry’s 19.5% decline.
NVAX’s surprise record has been dismal so far, as its earnings missed expectations in each of the last four quarters. It has a trailing four-quarter negative earnings surprise of 184.49%, on average. In the last reported quarter, Novavax witnessed a negative earnings surprise of 23.12%.
Let’s see how things have shaped up for the quarter to be reported.
Factors to Note
Novavax continued to garner authorizations for use of its COVID-19 vaccine in additional countries and for additional patient populations during the second quarter. In the second quarter, NVAX gained authorizations for use of its COVID vaccine in Japan, Switzerland, Taiwan and Thailand. All of these authorizations will aid NVAX to generate product revenues from the sale of its COVID vaccine. The Zacks Consensus Estimate for total revenues in the second quarter stands at $1.04 billion.
After a long-awaited period of time, NVAX secured emergency use authorization (EUA) from the FDA for its COVID vaccine as a primary two-dose regimen in adultsearlier this month. Though Novavax started shipping vaccine doses in the United States, it is not likely to recognize product revenues in the country until the beginning of the third quarter.
Following completion of the activities required under the agreements with the U.S. Government, we expect Novavax to record lower grant revenues during the quarter under review.
Novavax is also advancing the clinical development of booster studies of its COVID vaccine. In December 2021, the company initiated dosing patients in an extension of the phase III PREVENT-19 study to evaluate the third/booster dose of NVX-CoV2373. In April 2022, NVAX received the first approval for the use of a booster dose of NVX-CoV2373 in adults in Japan. Topline data from clinical studies evaluating its Omicron-specific booster vaccine is expected in second-half 2022. The company is also currently evaluating the booster dose of the vaccine in an ongoing late-stage study in adolescents.
We also expect management to provide an update on Novavax’s other pipeline candidates.
ResVax, Novavax’s potential respiratory syncytial virus (RSV) vaccine, is being evaluated in a phase III study to protect infants by immunizing their mothers against the disease.
Novavax also completed a phase III pivotal study on its nanoparticle seasonal influenza vaccine candidate NanoFlu for patients aged 65 years and above. The study met all the eight primary endpoints. An update on the timeline for regulatory filing of the vaccine is expected during the upcoming earnings call.
NVAX is also evaluating a COVID-19-influenza combination (CIC) vaccine candidate in a phase I/II study. The CIC vaccine is a combination of NVX-CoV2373 and NanoFlu in a single formulation. In April 2022, Novavax announced initial data from this study, which demonstrated the CIC vaccine to be feasible and immunogenic. The immune responses were comparable to the standalone NanoFlu and standalone NVX-CoV2373 formulations. NVAX expects to begin a phase II dose confirmation study by year end.$Novavax(NVAX)$
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