Novavax $NVAX Explosive Sales Growth, New Approval For COVID Vaccine In South Korea

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Novavax $NVAX stock moved 2.8% higher into the close on August 12, 2022, after the company announced that South Korea had approved its COVID-19 protein-based vaccine. Protein vaccines contain proteins of the virus that causes COVID-19. These virus pieces are the spike protein. The vaccine also contains another ingredient called an adjuvant that helps the immune system respond to that spike protein in the future. Unlike mRNA vaccines, a person’s DNA is not modified.

Novavax Nuvaxovid™ COVID-19 Vaccine Approved in South Korea for Use in Adolescents Aged 12 Through 17

On August 12, 2022, Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that its partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

“Today’s approval in South Korea is an important step in ensuring broad global access to a protein-based vaccine option,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax. “We are pleased to collaborate with SK bioscience to offer our vaccine to adolescents aged 12 through 17 in South Korea.”

Jaeyong Ahn, CEO of SK bioscience, said, “We are responding to the ongoing COVID-19 pandemic by expanding the use of Nuvaxovid for adolescents and as a booster. With CDMO manufacturing of global COVID-19 vaccines, including Nuvaxovid, we will do our best to promote human health in the world.”

The approval was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S. to evaluate the safety and effectiveness (immunogenicity) and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% overall clinical efficacy when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Severe adverse events were low in number, balanced between vaccine and placebo groups, and not considered related to the vaccine. After the first and second dose, local and systemic reactogenicity was generally lower than or similar to adults. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the study.

In the 12 through the 17-year-old population, Nuvaxovid has been granted authorization in India, the European Union, Australia, Thailand, and Japan and is actively under review in other markets.

KMFDS approved Nuvaxovid for use in adults aged 18 and older in January 2022. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substances and drug products of Nuvaxovid for domestic use.

🚨 Novavax Reports Big Second Quarter 2022 Financial Misses, Stock Plunges

On August 8, 2022, Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced its financial results and operational highlights for the second quarter ended June 30, 2022. Novavax reported Q2 EPS of ($6.53) versus the ($4.75) of Q2 last year. The company reported Q2 revenue of $186M versus the $298M of Q2 last year.

“We are pleased with our progress since the start of the second quarter, which importantly included delivering our vaccine to the U.S. market with immunizations underway,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax. “With over 23 million doses delivered since the start of the third quarter, we are distributing our vaccine globally and have gained positive momentum as we move into the remainder of 2022 and 2023. Through continued expansions to our label for adolescents and boosting and our vaccine’s competitive product profile, we are confident it will play an important role in the long-term COVID-19 landscape.”

Second Quarter 2022 and Recent Highlights

  • Received Emergency Use Authorization (EUA) from United States (U.S.) Food and Drug Administration (FDA) with label expansion underway, marking the first protein-based COVID-19 vaccine available for use domestically
  • Authorized for primary series in adults 18 and older with unanimous recommendation received from U.S. Centers for Disease Control and Prevention (CDC)
  • Planned submission for boosting data from PREVENT-19 Phase 3 trial in August of 2022
  • Nuvaxovid or Covovax authorized in 43 countries for primary series in adults 18 and older, with additional label expansions received and underway in several geographies
  • Authorized for boosting in adults 18 and older in Japan, Australia, and New Zealand
  • Nuvaxovid filings completed in the European Union (EU), Great Britain, and Switzerland
  • Authorized for primary series in adolescents aged 12 through 17 in the EU, India, Australia, Japan, and Thailand
  • Nuvaxovid filings completed to the World Health Organization (WHO), Great Britain, Canada, Switzerland, New Zealand, and Taiwan
  • Expect to file for authorization of Omicron-containing vaccine with the U.S. FDA in the fourth quarter of 2022

COVID-19 Vaccine Manufacturing and Distribution

  • Delivered over 73 million doses of Nuvaxovid and Covovax globally to date, including 23 million doses since the start of the third quarter of 2022, reflecting strong momentum for the remainder of 2022
  • Secured order from U.S. government for 3.2 million initial doses under existing agreements, with distribution underway
  • Received approval from European Medicines Agency for SK bioscience to manufacture and supply the active substance in the Nuvaxovid COVID-19 vaccine to the EU
  • Expanded partnership with SK bioscience to support manufacturing of Omicron-containing vaccine and to manufacture vaccine in prefilled syringes for commercial supply in 2023

COVID-19 Clinical Development Program

  • Ongoing development of Omicron BA.1 specific vaccine (NVX-CoV2515), Omicron BA.5 specific vaccine, and bivalent format with prototype vaccine (NVX-CoV2373)
  • Announced positive preclinical boosting data for NVX-CoV2373, NVX-CoV2515, or bivalent formulation, demonstrating strong antibody levels
  • Ongoing Phase 3 strain change trial to assess safety and antibody responses following primary vaccination with mRNA vaccines; initial results expected near the end of the third quarter of 2022
  • Initiated Phase 2b/3 Hummingbird global clinical trial in younger children aged six months through 11 years, with initial results expected in the first quarter of 2023
  • Expected to enroll a total of 3,600 participants across nine countries, evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of NVX-CoV2373, followed by a booster at least six months after primary vaccination in three age cohorts
  • Advanced multiple studies evaluating homologous and heterologous boosting in adolescents for NVX-CoV2373
  • Completed administration of homologous third-dose booster for select participants in PREVENT-19 Phase 3 booster study in adolescents aged 12 through 17
  • Ongoing participation in the University of Oxford’s Com-COV3 Booster trial in adolescents aged 12 through 15 to evaluate heterologous boosting

COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development

  • Announced initial results of CIC Phase 1/2 trial demonstrating robust immune response with both stand-alone influenza and CIC vaccine candidates
  • Phase 3 trial to evaluate efficacy on track to be initiated in 2023

Financial Results for the Three Months Ended June 30, 2022

  • Total revenue for the second quarter of 2022 was $186 million, compared to $298 million for the comparable period in 2021. The second quarter of 2022 includes $78 million of revenue comprised of $55 million of product sales from NVX-CoV2373 based on three million doses sold by Novavax and $23 million of royalties, milestones, and adjuvant sales to our license partners. Grant revenue of $108 million in the second quarter of 2022 compared to $272 million in the prior year resulted from decreased activity under our agreements with the U.S. government and with the Coalition for Epidemic Preparedness Innovations.
  • The cost of sales for the second quarter of 2022 was $271 million. This includes $255 million in excess, obsolete, or expired inventory and losses on firm purchase commitments under our third-party supply agreements. The recognition of these costs was driven by a substantial reduction of our expected deliveries to COVAX and deferred deliveries to other customers. In 2021 and before receipt of regulatory authorizations for NVX-CoV2373, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized to inventory.
  • Research and development expenses for the second quarter of 2022 were $290 million compared to $571 million for the comparable period in 2021. The decrease was primarily the result of lower clinical development activities for NVX-CoV2373, the capitalization of NVX-CoV2373 manufacturing costs, and a net benefit from previously recognized embedded lease costs for manufacturing supply agreements during the second quarter of 2022.
  • Selling, general and administrative expenses for the second quarter of 2022 were $108 million compared to $73 million for the comparable period in 2021. The increase in the period was the result of activities in support of the commercialization of NVX-CoV2373.
  • Net loss for the second quarter of 2022 was $510 million compared to $352 million for the comparable period in 2021.
  • Cash, cash equivalents, and restricted cash were $1.4 billion as of June 30, 2022, compared to $1.5 billion as of December 31, 2021.

Financial Guidance

We are revising the complete 2022 total revenue guidance from $2 to $2.3 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants, royalties, and other revenue.

Bearish Option Flow Detected In $NVAX Stock

Guerilla Stock Trading has detected bearish option flow in Novavax $NVAX stock on August 12, 2022.

Nvax Bearish Option Flow

Make sure to review this lesson on option flow so that you understand the image above.

In particular, the January 20, 2023, put option with a strike of $17.50 has open interest trending higher. This favors the bears.

Nvax Jan Put Option Contract

Novavax Nuvaxovid receives expanded approval in Japan for ages 12-17

On July 26, 2022, Novavax (NVAX) announced that the Nuvaxovid COVID-19 vaccine received expanded manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare for primary immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 in adolescents aged 12 through 17. Novavax has partnered with Takeda (TAK) to develop, manufacture, and distribute Nuvaxovid in Japan.

Novavax Nuvaxovid granted provisional registration in Australia for ages 12-17

On July 26, 2022, Novavax announced the Australian Therapeutic Goods Agency has granted expanded approval for provisional registration of Nuvaxovid COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 to adolescents aged 12 through 17.

Novavax price target lowered to $171 from $181 at B. Riley

On July 22, 2022, B. Riley analyst Mayank Mamtani lowered the firm’s price target on Novavax to $171 from $181 and kept a Buy rating on the shares. The analyst attributes recent volatility in the shares amid unanimously positive U.S. regulatory and public health policy endorsements over the past several weeks primarily to fast-evolving investors’ perception of earnings due in mid-August. The Street is essentially in catch-up mode for gaining an appreciation of a generally Q2 solid top and bottom-line print and second-half outlook that isn’t adversely impacted by slowing of Q3 shipments, said Mamtani, whose price target change is driven by a pushout of projected second half orders to late Q4 and early 2023 coupled with modest BA.5 vaccine-related operating expense increases.

📺 Novavax CEO on COVID-19 boosters: ‘I dont think we’re too late’

Novavax CEO on COVID-19 boosters: ‘I dont think we’re too late’

📉 Novavax $NVAX Chart

After the company reported, the stock did a colossal gap-down opening on August 9, 2022. The stock is in a strong technical downtrend.

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