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Novavax (NVAX) Loss Widens in Q3, Revenues Lag Estimates
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Novavax, Inc. (NVAX - Free Report) incurred a loss of $3.21 per share in the third quarter of 2020, much wider than the year-ago quarter’s loss of 74 cents. The Zacks Consensus Estimate was of earnings of $2.36 per share. This significant loss was due to recognition of an expense of $187.2 million associated with the company’s manufacturing supply agreements for NVX-CoV2373, its COVID-19 vaccine candidate.
Revenues in the quarter were $157 million, reflecting a significant increase year over year owing to the funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and other funding sources, such as the department of defense and the US government under Operation Warp Speed (OWS) in relation to the clinical development of NVX-CoV2373. However, the top line missed the Zacks Consensus Estimate of $234 million.
The company received a $2-billion funding from the CEPI (up to $399 million), the U.S. government’s OWS ($1.6 billion) and U.S. Department of Defense for developing NVX-CoV2373.
Shares of Novavax were down 4.6% in after-hours trading on Monday following the weaker-than-expected earnings results. However, the stock has skyrocketed 2169.1% year to date against the industry’s decrease of 2.2%.
Quarter in Detail
In the reported quarter, research and development expenses were $294.1 million, significantly up from the year-ago figure due to higher costs for the development of NVX-CoV2373 and inclusion of the expense of $187.2 million mentioned above.
General and administrative expenses also rose significantly year over year to $56.9 million due to higher professional fees for supporting NVX-CoV2373’s development and employee-related expenses.
As of Sep 30, 2020, Novavax had cash, cash equivalents, marketable securities and restricted cash worth $571.6 million compared with $609.5 million as of Jun 30, 2020.
Update on COVID-19 Vaccine and Other Pipeline Developments
In September 2020, Novavax initiated the first phase III study, evaluating the safety, efficacy and immunogenicity of NVX-CoV2373 in the United Kingdom.
In October 2020, the company expanded the study to 15,000 volunteers, having already enrolled around 9,000 participants to date. Interim data from the same is expected in the first quarter of 2021.
Meanwhile, the phase III study of NVX-CoV2373 in the United States and Mexico is expected to begin by the end of this month. This study is being conducted under the U.S. government’s OWS. NVX-CoV2373 was granted a Fast Track designation from the FDA.
Novavax also started a phase IIb study in South Africa to evaluate the efficacy of NVX-CoV2373.
Notably, in September 2020, Novavax amended the existing agreement with the Serum Institute of India Private Limited (SIIPL), under which the latter will also manufacture the antigen component of NVX-CoV2373. Following this, the company increased its manufacturing capacity for the vaccine candidate to more than two billion doses annually by mid-2021.
Meanwhile, Novavax signed manufacturing supply agreements for NVX-CoV2373 with several companies across the globe. Apart from SIIPL in India, Biofabri in Spain, FUJIFILM Diosynth Biotechnologies (FDB) in the United States and the United Kingdom, SK Bioscience in the Republic of Korea and Takeda Pharmaceutical Company Ltd. (TAK - Free Report) in Japan are manufacturing the vaccine candidate.
Apart from the coronavirus vaccine, Novavax is developing its nanoparticle seasonal influenza vaccine candidate NanoFlu for senior patients, aged 65 years and above. The company successfully completed a phase III study on the same earlier this year. NanoFlu was found non-inferior to Sanofi’s (SNY - Free Report) influenza vaccine Fluzone.
Novavax will file a biologics license application (BLA) to the FDA shortly, seeking an accelerated approval for NanoFlu. The company is also looking to explore a combined NanoFlu/NVX-CoV2373 vaccine, which can be used in a post-pandemic scenario.
Fulcrum Therapeutics’ loss per share estimates have narrowed 1.1% for 2020 and 0.9% for 2021 over the past 60 days.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Novavax (NVAX) Loss Widens in Q3, Revenues Lag Estimates
Novavax, Inc. (NVAX - Free Report) incurred a loss of $3.21 per share in the third quarter of 2020, much wider than the year-ago quarter’s loss of 74 cents. The Zacks Consensus Estimate was of earnings of $2.36 per share. This significant loss was due to recognition of an expense of $187.2 million associated with the company’s manufacturing supply agreements for NVX-CoV2373, its COVID-19 vaccine candidate.
Revenues in the quarter were $157 million, reflecting a significant increase year over year owing to the funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and other funding sources, such as the department of defense and the US government under Operation Warp Speed (OWS) in relation to the clinical development of NVX-CoV2373. However, the top line missed the Zacks Consensus Estimate of $234 million.
The company received a $2-billion funding from the CEPI (up to $399 million), the U.S. government’s OWS ($1.6 billion) and U.S. Department of Defense for developing NVX-CoV2373.
Shares of Novavax were down 4.6% in after-hours trading on Monday following the weaker-than-expected earnings results. However, the stock has skyrocketed 2169.1% year to date against the industry’s decrease of 2.2%.
Quarter in Detail
In the reported quarter, research and development expenses were $294.1 million, significantly up from the year-ago figure due to higher costs for the development of NVX-CoV2373 and inclusion of the expense of $187.2 million mentioned above.
General and administrative expenses also rose significantly year over year to $56.9 million due to higher professional fees for supporting NVX-CoV2373’s development and employee-related expenses.
As of Sep 30, 2020, Novavax had cash, cash equivalents, marketable securities and restricted cash worth $571.6 million compared with $609.5 million as of Jun 30, 2020.
Update on COVID-19 Vaccine and Other Pipeline Developments
In September 2020, Novavax initiated the first phase III study, evaluating the safety, efficacy and immunogenicity of NVX-CoV2373 in the United Kingdom.
In October 2020, the company expanded the study to 15,000 volunteers, having already enrolled around 9,000 participants to date. Interim data from the same is expected in the first quarter of 2021.
Meanwhile, the phase III study of NVX-CoV2373 in the United States and Mexico is expected to begin by the end of this month. This study is being conducted under the U.S. government’s OWS. NVX-CoV2373 was granted a Fast Track designation from the FDA.
Novavax also started a phase IIb study in South Africa to evaluate the efficacy of NVX-CoV2373.
Notably, in September 2020, Novavax amended the existing agreement with the Serum Institute of India Private Limited (SIIPL), under which the latter will also manufacture the antigen component of NVX-CoV2373. Following this, the company increased its manufacturing capacity for the vaccine candidate to more than two billion doses annually by mid-2021.
Meanwhile, Novavax signed manufacturing supply agreements for NVX-CoV2373 with several companies across the globe. Apart from SIIPL in India, Biofabri in Spain, FUJIFILM Diosynth Biotechnologies (FDB) in the United States and the United Kingdom, SK Bioscience in the Republic of Korea and Takeda Pharmaceutical Company Ltd. (TAK - Free Report) in Japan are manufacturing the vaccine candidate.
Apart from the coronavirus vaccine, Novavax is developing its nanoparticle seasonal influenza vaccine candidate NanoFlu for senior patients, aged 65 years and above. The company successfully completed a phase III study on the same earlier this year. NanoFlu was found non-inferior to Sanofi’s (SNY - Free Report) influenza vaccine Fluzone.
Novavax will file a biologics license application (BLA) to the FDA shortly, seeking an accelerated approval for NanoFlu. The company is also looking to explore a combined NanoFlu/NVX-CoV2373 vaccine, which can be used in a post-pandemic scenario.
Novavax, Inc. Price, Consensus and EPS Surprise
Novavax, Inc. price-consensus-eps-surprise-chart | Novavax, Inc. Quote
Zacks Rank & Stocks to Consider
Novavax currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Fulcrum Therapeutics, Inc. (FULC - Free Report) which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Fulcrum Therapeutics’ loss per share estimates have narrowed 1.1% for 2020 and 0.9% for 2021 over the past 60 days.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>