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Novavax's (NVAX) Q4 Loss Wider Than Expected, 2022 View Weak
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Novavax, Inc. (NVAX - Free Report) incurred a loss of $11.18 per share for fourth-quarter 2021, wider than the year-ago loss of $2.70 and the Zacks Consensus Estimate of a loss of $1.43.
The increase in year-over-year loss was on account of higher expenses incurred for the development and manufacturing of NVX-CoV2373 — the company’s protein-based COVID-19 vaccine — in advance, anticipating regulatory authorizations for the same.
Revenues for the quarter were $222 million, down 20.5% year over year. Revenues also missed the Zacks Consensus Estimate of $385.6 million.
Quarter in Detail
For the fourth quarter, royalties and other revenues rose more than 500% to $127.2 million. This was on account of the sale of NVX-CoV2373 in Indonesia and South Korea by Novavax’s partners. The company’s grant revenues significantly declined 63.4% year over year to $95 million for the same period.
For the reported quarter, research and development expenses were $963 million, up 140% year over year.
General and administrative expenses rose 37.4% year over year to $84 million.
As of Dec 31, 2021, Novavax had $1.5 billion of cash and cash equivalents compared with $1.9 billion as of Sep 30, 2021.
Full-Year Results
For 2021, Novavax generated revenues of $1.1 billion, reflecting a significant year-over-year surge from the year-ago figure of $476 million.
For the same period, the company incurred a loss of $23.44 per share in comparison with the year-ago loss of $7.27.
2022 Guidance
Novavax expects total revenues for the full year between $4 billion and $5 billion. The guidance fell short of the Zacks Consensus Estimate of $5.2 billion
Shares of Novavax were down 7.2% in after-hours trading on Monday, following dismal earnings and weak financial guidance for 2022. In fact, the stock has declined 41.7% so far this year in comparison with the industry’s 15.8% decrease.
Image Source: Zacks Investment Research
Update on COVID-19 Vaccine/Other Pipeline
Overall, Novavax’s vaccine has been authorized for use by 12 regulatory authorities.
During the fourth quarter, Novavax received authorization for its COVID-19 vaccine in Indonesia, Philippines, European Union and India. In 2022, the vaccine also received authorization for use in multiple markets including Australia, Canada, Great Britain and South Korea. Commercial roll-out in some of these markets has been initiated since December 2021.
We note that NVX-CoV2373 is also the first protein-based COVID-19 vaccine authorized for use in multiple markets around the world including Australia, Canada and Europe.
Novavax is currently marketing two versions of NVX-CoV2373 — one marketed in partnership with the Serum Institute of India (Serum) under the trade name Covovax and another produced by Novavax and marketed under the trade name Nuvaxovid. Both versions of the vaccine were granted emergency use listing by the World Health Organisation in December 2021.
After multiple delays, Novavax finally filed for Emergency Use Authorization of its COVID-19 vaccine with the FDA last month. Regulatory filings seeking approval for NVX-CoV2373 have also been filed in Japan and South Africa.
Novavax is also evaluating the vaccine across multiple studies. Earlier this month, NVAX reported that its COVID vaccine generated neutralizing antibodies in adolescents from 12 to 17 years of age, similar to the antibody responses in young adult patients (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT study. In December 2021, Novavax initiated dosing patients in an extension of the phase III PREVENT-19 study to evaluate the third/booster dose of its COVID vaccine. Novavax is also developing an Omicron-specific vaccine that is currently undergoing GMP manufacturing. A manufactured version is expected by the end of first-quarter 2022.
NVAX initiated patient enrollment in a phase I/II study last September to evaluate the combination of NVX-CoV2373 and its seasonal influenza vaccine candidate, NanoFlu, in a single formulation. While data from the phase I portion is anticipated this April, the company expects to begin the phase II portion of the study in second-half 2022.
If approved in the United States, Novavax’s COVID vaccine will face stiff competition from the COVID vaccines developed by Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , which currently dominate the U.S. market. In fact, the COVID vaccines developed by Pfizer/BioNTech and Moderna are currently the only ones that have received full approval in the United States.
The vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen. Please note that the booster doses of these vaccines are also approved for use in the United States. In fact, the booster shot of the Moderna and Pfizer/BioNTech vaccines are also authorized for heterologous (or “mix and match”) use, following completion of a primary vaccine regimen of any FDA-approved COVID vaccine.
To broaden its COVID vaccine supply and fulfill its existing commitments, the company has achieved the capacity to manufacture more than 2 billion doses of the vaccine annually. In its earnings call, the company announced that it plans to pursue full approval of its COVID vaccine in second-half 2022.
Image: Shutterstock
Novavax's (NVAX) Q4 Loss Wider Than Expected, 2022 View Weak
Novavax, Inc. (NVAX - Free Report) incurred a loss of $11.18 per share for fourth-quarter 2021, wider than the year-ago loss of $2.70 and the Zacks Consensus Estimate of a loss of $1.43.
The increase in year-over-year loss was on account of higher expenses incurred for the development and manufacturing of NVX-CoV2373 — the company’s protein-based COVID-19 vaccine — in advance, anticipating regulatory authorizations for the same.
Revenues for the quarter were $222 million, down 20.5% year over year. Revenues also missed the Zacks Consensus Estimate of $385.6 million.
Quarter in Detail
For the fourth quarter, royalties and other revenues rose more than 500% to $127.2 million. This was on account of the sale of NVX-CoV2373 in Indonesia and South Korea by Novavax’s partners. The company’s grant revenues significantly declined 63.4% year over year to $95 million for the same period.
For the reported quarter, research and development expenses were $963 million, up 140% year over year.
General and administrative expenses rose 37.4% year over year to $84 million.
As of Dec 31, 2021, Novavax had $1.5 billion of cash and cash equivalents compared with $1.9 billion as of Sep 30, 2021.
Full-Year Results
For 2021, Novavax generated revenues of $1.1 billion, reflecting a significant year-over-year surge from the year-ago figure of $476 million.
For the same period, the company incurred a loss of $23.44 per share in comparison with the year-ago loss of $7.27.
2022 Guidance
Novavax expects total revenues for the full year between $4 billion and $5 billion. The guidance fell short of the Zacks Consensus Estimate of $5.2 billion
Shares of Novavax were down 7.2% in after-hours trading on Monday, following dismal earnings and weak financial guidance for 2022. In fact, the stock has declined 41.7% so far this year in comparison with the industry’s 15.8% decrease.
Image Source: Zacks Investment Research
Update on COVID-19 Vaccine/Other Pipeline
Overall, Novavax’s vaccine has been authorized for use by 12 regulatory authorities.
During the fourth quarter, Novavax received authorization for its COVID-19 vaccine in Indonesia, Philippines, European Union and India. In 2022, the vaccine also received authorization for use in multiple markets including Australia, Canada, Great Britain and South Korea. Commercial roll-out in some of these markets has been initiated since December 2021.
We note that NVX-CoV2373 is also the first protein-based COVID-19 vaccine authorized for use in multiple markets around the world including Australia, Canada and Europe.
Novavax is currently marketing two versions of NVX-CoV2373 — one marketed in partnership with the Serum Institute of India (Serum) under the trade name Covovax and another produced by Novavax and marketed under the trade name Nuvaxovid. Both versions of the vaccine were granted emergency use listing by the World Health Organisation in December 2021.
After multiple delays, Novavax finally filed for Emergency Use Authorization of its COVID-19 vaccine with the FDA last month. Regulatory filings seeking approval for NVX-CoV2373 have also been filed in Japan and South Africa.
Novavax is also evaluating the vaccine across multiple studies. Earlier this month, NVAX reported that its COVID vaccine generated neutralizing antibodies in adolescents from 12 to 17 years of age, similar to the antibody responses in young adult patients (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT study. In December 2021, Novavax initiated dosing patients in an extension of the phase III PREVENT-19 study to evaluate the third/booster dose of its COVID vaccine. Novavax is also developing an Omicron-specific vaccine that is currently undergoing GMP manufacturing. A manufactured version is expected by the end of first-quarter 2022.
NVAX initiated patient enrollment in a phase I/II study last September to evaluate the combination of NVX-CoV2373 and its seasonal influenza vaccine candidate, NanoFlu, in a single formulation. While data from the phase I portion is anticipated this April, the company expects to begin the phase II portion of the study in second-half 2022.
If approved in the United States, Novavax’s COVID vaccine will face stiff competition from the COVID vaccines developed by Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , which currently dominate the U.S. market. In fact, the COVID vaccines developed by Pfizer/BioNTech and Moderna are currently the only ones that have received full approval in the United States.
The vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen. Please note that the booster doses of these vaccines are also approved for use in the United States. In fact, the booster shot of the Moderna and Pfizer/BioNTech vaccines are also authorized for heterologous (or “mix and match”) use, following completion of a primary vaccine regimen of any FDA-approved COVID vaccine.
To broaden its COVID vaccine supply and fulfill its existing commitments, the company has achieved the capacity to manufacture more than 2 billion doses of the vaccine annually. In its earnings call, the company announced that it plans to pursue full approval of its COVID vaccine in second-half 2022.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Zacks Rank
Currently, Novavax has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.