Earnings release
Page 1
Novavax Investor Relations Novavax Reports Second Quarter 2021 Financial Results and Operational Highlights - Filed regulatory submissions for EUA in India , Indonesia and the Philippines , in partnership with Serum Institute of India -Demonstrated greater than 4 - fold increase in neutralizing antibody levels versus peak responses after primary vaccination in 6 - month booster study - Cross - reactive functional antibodies to Delta ( B.1.617.2 ) variant detected after primary vaccination series and increased more than 6 - fold upon boosting at 6 months - Finalized APA with European Commission to supply up to 200 million doses - Demonstrated high efficacy across variants in PREVENT - 19 Phase 3 trial - Announced positive results from first clinical study of influenza vaccine and COVID - 19 vaccine candidate administered simultaneously On track to achieve 100 million dose monthly capacity by the end of the third quarter and 150 million dose monthly capacity by the end of the fourth quarter - Company to host conference call today at 4:30 p.m. ET GAITHERSBURG , Md . , Aug. 5 , 2021 / PRNewswire / --Novavax , Inc. ( NASDAQ : NVAX ) , a biotechnology company developing next - generation vaccines for serious infectious diseases , today announced its financial results and operational highlights for the second quarter ended June 30 , 2021 . " We are highly encouraged by the filing of regulatory submissions in multiple markets , made in partnership with Serum Institute of India . We view these submissions as the first of many filings to come , which will allow NVX CoV2373 to be made available at a global scale , " said Stanley C. Erck , President and Chief Executive Officer , Novavax . " Our clinical successes over the second quarter reaffirm our confidence in NVX - CoV2373's differentiated efficacy profile . We continue to see the circulation of new variants and inequitable access to vaccine globally , demanding that we bring our COVID - 19 vaccine to market as swiftly as possible . " Second Quarter 2021 and Recent Highlights COVID - 19 Vaccine Clinical and Non - Clinical Development • Reported final analysis from PREVENT - 19 U.S. and Mexico Phase 3 trial o Achieved primary efficacy endpoint with overall efficacy of 90.4 % against mild , moderate , and severe disease o Demonstrated 100 % protection against moderate and severe disease o Demonstrated 91.0 % efficacy among high - risk populations o Demonstrated 92.6 % efficacy against Variants of Concern / Variants of Interest ( VoC / Vol ) and 100 % efficacy against variants not considered VoC / Vol • Completed enrollment of pediatric expansion of PREVENT - 19 Phase 3 trial o Enrolled 2,248 adolescents aged 12-17 across up to 75 sites in the U.S. o Blinded crossover expected to begin in August 2021 to ensure all participants have access to active vaccine • Published results from late - stage South Africa Phase 2b and UK Phase 3 trials in The New England Journal of Medicine • Completed UK Phase 3 crossover arms and initiated crossover studies in PREVENT - 19 and South Africa Phase 2b trials to ensure all participants have access to active vaccine • Advanced clinical development of booster studies of NVX - CoV2373 • Reported 6 - month booster data from U.S. and Australia Phase 2 trial Wild - type neutralizing antibodies increased more than 4 - fold versus primary vaccination series ■ Cross - reactive functional antibodies to the Delta ( B.1.617.2 ) variant strain detected after primary