Full Press Release Details
Novavax Reports First Quarter 2022 Financial
Results and Operational Highlights
GAITHERSBURG, Md., May 9, 2022 -
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious
infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2022.
"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+
Progressed COVID-19 Vaccine Regulatory Pathway for Children Aged
COVID-19-Influenza Combination (CIC) Vaccine
Candidate Clinical Development
COVID-19 Vaccine Supply and Distribution
COVID-19 Vaccine Clinical Development
Financial Results for the Three Months Ended
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
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.
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.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology
company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent
serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering
to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19
vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine,
Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines
NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax'
proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com
and connect with us on Twitter, LinkedIn, Instagram
*NanoFlu identifies a recombinant hemagglutinin
(HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled
phase 3 trial conducted during the 2019-2020 influenza season.
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its operating plans and prospects, its partnerships, financial guidance, the timing of clinical trial results, the ongoing development
of NVX-CoV2373, including Novavax' plans to initiate a pediatric study in Q2 2022, a COVID-19-Influenza combination vaccine candidate,
including plans to initiate a Phase 2 clinical trial by the end of 2022, the scope, timing and outcome of future regulatory filings and
actions, including Novavax' upcoming FDA Advisory Committee meeting and including Novavax' plans for additional global submissions
throughout the second quarter of 2022, the potential impact of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the
pandemic and protecting populations, including the potential reach of NVX-CoV2373, the efficacy, safety and intended utilization of NVX-CoV2373
and COVID-19-Influenza combination vaccine candidate, and expected administration of NVX-CoV2373, including a Omicron-specific vaccine,
are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties
include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities;
unanticipated challenges or delays in conducting clinical trials; difficulty obtaining scarce raw materials and supplies; resource constraints,
including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting
contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified
in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations"
sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission
(SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as
of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial
risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration
to these risks and uncertainties.
| NOVAVAX, INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| (in thousands, except per share information) |
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Revenue: | ||||||||
| Product sales | $ | 585,628 | $ | -- | ||||
| Grants | 99,301 | 446,893 | ||||||
| Royalties and other | 19,042 | 336 | ||||||
| Total revenue | 703,971 | 447,229 | ||||||
| Expenses: | ||||||||
| Cost of sales | 15,204 | -- | ||||||
| Research and development | 383,483 | 592,671 | ||||||
| Selling, general, and administrative | 95,992 | 63,190 | ||||||
| Total expenses | 494,679 | 655,861 | ||||||
| Income (loss) from operations | 209,292 | (208,632 | ) | |||||
| Other income (expense): | ||||||||
| Interest income (expense) | (4,876 | ) | (4,839 | ) | ||||
| Other income (expense) | 1,654 | (6,231 | ) | |||||
| Income (loss) before income tax expense | 206,070 | (219,702 | ) | |||||
| Income tax expense | 2,662 | 3,017 | ||||||
| Net income (loss) | $ | 203,408 | $ | (222,719 | ) | |||
| Net income (loss) per share | ||||||||
| Basic | $ | 2.66 | $ | (3.05 | ) | |||
| Diluted | $ | 2.56 | $ | (3.05 | ) | |||
| Weighted average number of common shares outstanding | ||||||||
| Basic | 76,457 | 73,035 | ||||||
| Diluted | 80,711 | 73,035 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| March 31, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 1,570,954 | $ | 1,515,116 | ||||
| Total restricted cash | 13,146 | 13,143 | ||||||
| Total current assets | 2,347,405 | 2,155,119 | ||||||
| Working capital | 86,400 | (235,200 | ) | |||||
| Total assets | 2,834,875 | 2,576,753 | ||||||
| Convertible notes payable* | 323,814 | 323,458 | ||||||
| Total stockholders' equity (deficit) | 65,324 | (351,673 | ) |
* Included in current liabilities as of March 31, 2022 and non-current
liabilities as of December 31, 2021
Alex Delacroix | 240-268-2022
Alison Chartan | 240-720-7804