On May 9, 2022 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the first quarter ended March 31, 2022 (Press release, Novavax, MAY 9, 2022, View Source [SID1234613970]).
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"Novavax has been successful in launching our protein-based COVID-19 vaccine worldwide and executing on our plans for ongoing label expansions for pediatrics and homologous and heterologous boosting. Reinforced by our first profitable quarter, with $704 million in revenue, we are continuing our robust commercial rollout." said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Importantly, as new variants have emerged, we have progressed our strategy to be ready to address the dynamic environment and continue development beyond COVID-19 with our COVID-19-Influenza Combination vaccine candidate."
First Quarter 2022 and Recent Highlights
Expanded Worldwide Authorizations for COVID-19 Primary and Booster Vaccination in Adult Population Aged 18+
Received manufacturing and marketing approval with our partner Takeda Pharmaceutical Company Limited, in Japan for Nuvaxovid for primary, heterologous and homologous boosting indications
Granted authorization (emergency use, provisional, interim or conditional) for Nuvaxovid in Great Britain, Canada, Australia, Switzerland, Singapore and New Zealand
Received full regulatory approval for Nuvaxovid in South Korea with our partner SK bioscience, becoming the first protein-based vaccine approved in South Korea
Granted emergency use authorization (EUA) for Covovax with our partner the Serum Institute of India Pvt. Ltd. (SII) in Thailand and Bangladesh
Submitted request for EUA to U.S. FDA and, with SII, filed for EUA in South Africa
FDA scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for June 7th
Progressed COVID-19 Vaccine Regulatory Pathway for Children Aged 12-17 Years
Granted EUA for adolescents in India with SII for Covovax
Submitted requests for authorization for Nuvaxovid in adolescents to the European Union, Great Britain, Australia and New Zealand
Filed for approval of Nuvaxovid with SK bioscience, for adolescents in South Korea
Additional global submissions planned throughout the second quarter of 2022
COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development
Announced initial results of CIC Phase 1/2 trial, combining NVX-CoV2373 and quadrivalent influenza vaccine candidate
Immune response confirmed in stand-alone influenza vaccine candidate and CIC vaccine candidate with potential path forward for both
Demonstrated combined formulation has potential to reduce total antigen amount by up to 50% overall
Expect to begin CIC Phase 2 trial by the end of 2022
COVID-19 Vaccine Supply and Distribution
Delivered Nuvaxovid globally to European Union, Canada, Australia, Thailand, Singapore and New Zealand and with SK bioscience to South Korea
COVID-19 Vaccine Clinical Development
UK Phase 3 study demonstrated ongoing durability of protection against infection and disease in long term follow-up (median of 101 days)
82.5% efficacy in protection against all COVID-19 infection, as measured by PCR+ or anti-N seroconversion
82.7% overall efficacy against disease
100% efficacy against severe disease
Continued rapid development and assessment of strain change, including Omicron-specific clinical studies with topline readout expected in third quarter of 2022
Evaluating benefit of Omicron-specific (BA.1 and BA.2) or bivalent vaccine compared to current prototype, with first doses expected this month
Progressed South Africa Phase 2 study with ongoing administration in participants to evaluate a three-dose regimen and different dosing schedules in -immunocompromised participants, providing flexibility to national delivery programs
Topline results expected in fourth quarter of 2022
Progressed PREVENT-19 Phase 3 study in adolescents aged 12-17 years
Achieved primary effectiveness endpoint and demonstrated comparability to adult population
Demonstrated 80% overall clinical efficacy and 82% efficacy against Delta variant
Vaccine was generally well-tolerated and safety profile was consistent with previous studies
Initiated booster study to evaluate safety and immunogenicity of a third dose
Continued clinical trials in younger age groups to build on positive pediatric data
Expect to initiate PREVENT-19 Phase 3 trial in younger age groups (5-11 years) by third quarter of 2022
SII generated positive data from Phase 2/3 India study in children ages 2-17 years showing robust immune responses with favorable reactogenicity profiles
Announced participation in Phase 1/2 heterologous booster study sponsored by National Institute of Allergy and Infectious Diseases
Evaluating safety, reactogenicity and immunogenicity of heterologous boosters in approximately 180 individuals aged 18 years or older
Topline results expected later this year and full results in 2023
Announced participation in Phase 3 study in the United Arab Emirates evaluating boost with NVX-CoV2373 in participants who were immunized with an inactive COVID-19 vaccine in individuals aged 18 years or older
Financial Results for the Three Months Ended March 31, 2022
Total revenue for the first quarter of 2022 was $704 million, compared to $447 million for the comparable period in 2021. First quarter of 2022 total revenue includes $605 million of revenue comprised of $586 million of product sales from NVX-CoV2373 based on 31 million doses sold by Novavax and $19 million of royalties and adjuvant sales to our license partners. Grant revenue of $99 million in the first quarter of 2022 compared to $447 million in the prior year resulted from a decrease in funding under our agreements with the U.S. government and with the Coalition for Epidemic Preparedness Innovations.
Cost of sales for the first quarter of 2022 were $15 million and 3% of product sales in the period. During 2021 and prior to 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 first quarter of 2022 were $383 million compared to $593 million for the comparable period in 2021. The decrease was primarily the result of lower clinical development activities for NVX-CoV2373 and the capitalization of NVX-CoV2373 manufacturing costs during the first quarter of 2022.
Selling, general and administrative expenses for the first quarter of 2022 were $96 million compared to $63 million for the comparable period in 2021. The increase in the period was the result of activities in support of the commercial launch of NVX-CoV2373.
Net income for the first quarter of 2022 was $203 million compared to a net loss of $223 million for the comparable period in 2021.
Cash, cash equivalents, and restricted cash were $1.6 billion as of March 31, 2022, compared to $1.5 billion as of December 31, 2021. Through sales of Novavax common stock pursuant to at-the-market (ATM) offerings during the first quarter of 2022, Novavax raised net proceeds of $179 million.
Financial Guidance
Novavax continues to expect to achieve its full year 2022 total revenue of between $4 and $5 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants revenue, royalties and other revenue.
Conference Call
Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (833) 974-2381 (Domestic) or (412) 317-5774 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on May 9, 2022 until 11:59 p.m. ET on May 16, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 9339969.
A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until August 9, 2022.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
About Matrix-M Adjuvant
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
About Novavax’ Influenza Program
Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax’ patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.