Novavax, Inc. NVAX recorded second-quarter 2020 loss per share of 30 cents, narrower than the Zacks Consensus Estimate of a loss of 57 cents and also the year ago quarter’s loss of $1.69.

Revenues in the quarter were $36 million, reflecting a significant increase year over year owing to the Coalition for Epidemic Preparedness Innovations’ (CEPI) funding related to the clinical development of Novavax’s COVID-19 vaccine candidate NVX-CoV2373. However, the top line missed the Zacks Consensus Estimate of $46 million.

The metric for the three months ended Jun 30, 2020 included revenues under the CEPI grant. The company expects revenues to significantly rise in 2020 owing to its NVX-CoV2373 program, which will be primarily funded by CEPI and other potential non-dilutive funding sources, namely the department of defense and US government under Operation Warp Speed (OWS).

Shares of Novavax have skyrocketed 4385.1% year to date compared with the industry’s increase of 5.3%.

Quarter in Detail

In the reported quarter, research and development expenses were $34.8 million, up 15% from the year-ago figure due to higher costs for the development of NVX-CoV2373.

However, general and administrative expenses rose 84% to $17.7 million due to higher professional fees and employee-related expenses.

As of Jun 30, 2020, Novavax had cash, cash equivalents, marketable securities and restricted cash worth $609.5 million compared with $244.7 million as of Mar 31, 2020.

Update on COVID-19 Vaccine and Other Pipeline Developments

The company was recently in the spotlight following its efforts to develop a novel vaccine against the deadly coronavirus disease (COVID-19).

The company has been actively engaged in developing its coronavirus vaccine NVX-CoV2373. It initiated a phase I/II study on the candidate in May. Earlier this month, Novavax released data on the first human trial of its COVID-19 vaccine candidate NVX-CoV2373. The clinical trial data showed that the vaccine was generally well-tolerated and elicited robust antibody responses, numerically superior to that seen in human convalescent sera (antibodies derived from blood donated by people who recovered from the illness).

Notably, the company received a $2-billion funding from the U.S. Department of Defense ($60 million), the CEPI ($388 million) and the U.S. government’s OWS ($1.6 billion) for developing NVX-CoV2373.

In August, Novavax entered into a license agreement with Serum Institute of India Private Limited for the development and commercialization of NVX-CoV2373 in low- and middle-income countries (LMIC) apart from India. The deal is expected to support a minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries starting January of 2021.

Novavax is also expanding its manufacturing capacities to support its clinical studies and a potential launch through collaborations and acquisitions.

Also, in August, Novavax and Takeda Pharmaceutical TAK entered into a partnership for the development, manufacturing and commercialization of NVX-CoV2373 in Japan.

Meanwhile, Novavax acquired Praha Vaccines in Czech Republic for approximately $167 million in cash during May. The acquisition added a biologics manufacturing facility, located in Bohumil, Czech Republic, which will likely provide an annual capacity of more than 1 billion doses of NVX-CoV2373 starting next year.

The company already has a deal with Emergent BioSolutions EBS to manufacture and supply GMP vaccine product for use in its clinical studies.

This apart, Novavax is developing its nanoparticle seasonal influenza vaccine candidate NanoFlu for senior patients, aged 65 years and above. In March 2020, it announced positive top-line data from a pivotal phase III study on the same. The candidate was non-inferior to Sanofi’s SNY influenza vaccine, Fluzone. The company plans to file a biologics license application (BLA) to the FDA soon, seeking an accelerated approval for NanoFlu.

Zacks Rank

Novavax is a Zacks Rank #2 (Buy) stock, currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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