Full Press Release Details
Novavax Reports Second Quarter 2022 Financial
Results and Operational Highlights
GAITHERSBURG, Md., August 8, 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 second quarter ended June 30, 2022.
"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
into 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
Progressed COVID-19 Global Regulatory Strategy
COVID-19 Vaccine Manufacturing and Distribution
COVID-19 Clinical Development Program
COVID-19-Influenza Combination (CIC) Vaccine
Candidate Clinical Development
Financial Results for the Three Months Ended
Revising full year 2022 total revenue guidance
to $2 to $2.3 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 August 8, 2022 until 11:59 p.m. ET on August 15, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412)
317-0088 (International) and use passcode 9237495.
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 November
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. The vaccine was created using Novavax'
recombinant nanoparticle technology to generate antigen derived from the coronavirus 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.
The 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, 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. The Novavax COVID-19 vaccine,
has received authorization from multiple regulatory authorities globally, including the U.S., European Commission and the WHO. The vaccine
is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents
and as a booster. 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, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original
strain-based vaccine. 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 LinkedIn.
*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 strategic priorities for 2022, its operating plans and prospects, financial guidance, its position in the global COVID-19 market,
its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, NVX-CoV2515, a bivalent vaccine candidate
and a COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions,
Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain,
the anticipated availability of Omicron-containing vaccine, additional worldwide authorizations of NVX-CoV2373 for use in adults and
adolescents and as a booster, the role that Novavax' COVID-19 vaccine will play in the long-term COVID-19 landscape, and the efficacy,
safety, intended utilization and expected administration of NVX-CoV2373 and Novavax' other vaccine candidates 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; the emergence of variants of the SARS-CoV-2 virus that may
negatively impact market acceptance or anticipated sales of NVX-CoV-2373; 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 and subsequent Quarterly Reports on Form 10-Q, 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except
per share information)
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Revenue: | ||||||||
| Product sales | $ | 55,455 | $ | -- | ||||
| Grants | 107,774 | 272,489 | ||||||
| Royalties and other | 22,696 | 25,528 | ||||||
| Total revenue | 185,925 | 298,017 | ||||||
| Expenses: | ||||||||
| Cost of sales | 271,077 | -- | ||||||
| Research and development | 289,648 | 570,685 | ||||||
| Selling, general, and administrative | 108,160 | 73,161 | ||||||
| Total expenses | 668,885 | 643,846 | ||||||
| Income (loss) from operations | (482,960 | ) | (345,829 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense) | (6,234 | ) | (5,968 | ) | ||||
| Other income (expense) | (19,873 | ) | 3,028 | |||||
| Income (loss) before income tax expense | (509,067 | ) | (348,769 | ) | ||||
| Income tax expense | 1,418 | 3,548 | ||||||
| Net income (loss) | $ | (510,485 | ) | $ | (352,317 | ) | ||
| Net income (loss) per share | ||||||||
| Basic | $ | (6.53 | ) | $ | (4.75 | ) | ||
| Weighted average number of common shares outstanding Basic | 78,143 | 74,118 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| June 30, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 1,375,587 | $ | 1,515,116 | ||||
| Total restricted cash | 11,928 | 13,143 | ||||||
| Total current assets | 2,136,002 | 2,155,119 | ||||||
| Working capital | (20,237 | ) | (235,200 | ) | ||||
| Total assets | 2,622,993 | 2,576,753 | ||||||
| Convertible notes payable* | 324,169 | 323,458 | ||||||
| Total stockholders' equity (deficit) | (416,950 | ) | (351,673 | ) |
* Included in current liabilities as of June 30, 2022 and non-current
liabilities as of December 31, 2021
Erika Schultz | 240-268-2022
Ali Chartan or Giovanna Chandler | 202-709-5563