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Novavax's (NVAX) Q3 Loss Widens, Revenues Lag Estimates
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Novavax, Inc. (NVAX - Free Report) incurred a loss of $4.31 per share in the third quarter of 2021, wider than the year-ago quarter’s loss of $3.21 as well as the Zacks Consensus Estimate of a loss of $4.04.
The year-over-year loss was due to higher operating costs incurred to support the development of NVX-CoV2373, its COVID-19 vaccine candidate.
Revenues in the quarter were $178.8 million, up 13.9% year over year. Revenues increased owing to services performed under the agreement with the Coalition for Epidemic Preparedness Innovations and participation in the U.S. government’s Operation Warp Speed in relation to the clinical development of NVX-CoV2373. Revenues, however, missed the Zacks Consensus Estimate of $307 million.
Shares of Novavax were down in after-hours trading on Thursday and also declined in pre-market trading on Friday following the weaker-than-expected earnings result. The stock has rallied 60.9% so far this year against the industry’s decline of 6.8%.
Image Source: Zacks Investment Research
Quarter in Detail
In the reported quarter, research and development expenses were $408.2 million, up 38.8% year over year due to higher expenses incurred for the development of NVX-CoV2373.
General and administrative expenses rose 36.7% year over year to $77.8 million due to higher costs for supporting NVX-CoV2373’s development.
As of Sep 30, 2021, Novavax had $1.9 billion of cash and cash equivalents compared with $2.1 billion as of Jun 30, 2021.
Update on COVID-19 Vaccine/Other Pipeline
Novavax already received emergency use authorization (EUA) for NVX-CoV2373 in Indonesia in partnership with the Serum Institute of India (SII). The vaccine will be marketed under the brand name COVOVAX by SII.
The company filed regulatory submissions for NVX-CoV2373 in the United Kingdom, Australia, Canada, New Zealand, the EU, India and the Philippines. The company filed a regulatory application to the World Health Organization (WHO) for the emergency use listing (EUL) of its COVID-19 vaccine across nations participating in the COVAX facility during September. The company plans to submit a EUA request to the FDA by 2021end.
If approved, Novavax’s COVID-19 vaccine candidate will be the fourth vaccine to be available in the United States. At present, Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States.
The company aims at manufacturing 150 million doses per month by the end of 2021. It also signed advance purchase agreements with different countries and organizations for supplying more than one billion doses.
NVX-CoV2373 is also being evaluated in studies in adolescents aged between 12 years and less than 17 years.
In September 2021, Novavax began patient enrollment in a phase I/II study to evaluate a combination of NVX-CoV2373 and seasonal influenza vaccine candidate NanoFlu (COVID-NanoFlu combination vaccine). Data from the same is expected in the first half of 2022.
We note that the company 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.
Image: Shutterstock
Novavax's (NVAX) Q3 Loss Widens, Revenues Lag Estimates
Novavax, Inc. (NVAX - Free Report) incurred a loss of $4.31 per share in the third quarter of 2021, wider than the year-ago quarter’s loss of $3.21 as well as the Zacks Consensus Estimate of a loss of $4.04.
The year-over-year loss was due to higher operating costs incurred to support the development of NVX-CoV2373, its COVID-19 vaccine candidate.
Revenues in the quarter were $178.8 million, up 13.9% year over year. Revenues increased owing to services performed under the agreement with the Coalition for Epidemic Preparedness Innovations and participation in the U.S. government’s Operation Warp Speed in relation to the clinical development of NVX-CoV2373. Revenues, however, missed the Zacks Consensus Estimate of $307 million.
Shares of Novavax were down in after-hours trading on Thursday and also declined in pre-market trading on Friday following the weaker-than-expected earnings result. The stock has rallied 60.9% so far this year against the industry’s decline of 6.8%.
Quarter in Detail
In the reported quarter, research and development expenses were $408.2 million, up 38.8% year over year due to higher expenses incurred for the development of NVX-CoV2373.
General and administrative expenses rose 36.7% year over year to $77.8 million due to higher costs for supporting NVX-CoV2373’s development.
As of Sep 30, 2021, Novavax had $1.9 billion of cash and cash equivalents compared with $2.1 billion as of Jun 30, 2021.
Update on COVID-19 Vaccine/Other Pipeline
Novavax already received emergency use authorization (EUA) for NVX-CoV2373 in Indonesia in partnership with the Serum Institute of India (SII). The vaccine will be marketed under the brand name COVOVAX by SII.
The company filed regulatory submissions for NVX-CoV2373 in the United Kingdom, Australia, Canada, New Zealand, the EU, India and the Philippines. The company filed a regulatory application to the World Health Organization (WHO) for the emergency use listing (EUL) of its COVID-19 vaccine across nations participating in the COVAX facility during September. The company plans to submit a EUA request to the FDA by 2021end.
If approved, Novavax’s COVID-19 vaccine candidate will be the fourth vaccine to be available in the United States. At present, Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States.
The company aims at manufacturing 150 million doses per month by the end of 2021. It also signed advance purchase agreements with different countries and organizations for supplying more than one billion doses.
NVX-CoV2373 is also being evaluated in studies in adolescents aged between 12 years and less than 17 years.
In September 2021, Novavax began patient enrollment in a phase I/II study to evaluate a combination of NVX-CoV2373 and seasonal influenza vaccine candidate NanoFlu (COVID-NanoFlu combination vaccine). Data from the same is expected in the first half of 2022.
We note that the company 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.
Novavax, Inc. Price, Consensus and EPS Surprise
Novavax, Inc. price-consensus-eps-surprise-chart | Novavax, Inc. Quote
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.