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Novavax Reports First Quarter 2024 Financial Results and Operational Highlights Announces co-exclusive licensing agreement with Sanofi to co-commercialize COVID-19 vaccine, develop novel COVID-19-Influenza

Key Takeaway: Novavax, Inc. has reported its financial results for the first quarter of 2024 and highlighted an important partnership with Sanofi. The companies have signed a co-exclusive licensing agreement to commercialize Novavax's COVID-19 vaccine and collaborate on developing a COVID-19-Influenza combination vaccine. This partnership aims to bolster Novavax's market position and funding for R&D projects. However, the agreement also brings challenges in ensuring successful implementation and navigating regulatory approvals for new vaccines.

Market Sentiment Analysis

POSITIVE FACTORS

  • Novavax has entered a co-exclusive licensing agreement with Sanofi, enhancing its commercial capabilities.
  • The partnership is expected to strengthen Novavax's financial position and support research and development.
  • Novavax is advancing its COVID-19 and influenza vaccine candidates, anticipating a successful Phase 3 trial.

CONCERNS & RISKS

  • Challenges may arise in transitioning key processes and technology between Novavax and Sanofi.
  • There are uncertainties associated with regulatory authorization for upcoming vaccine candidates.

Full Press Release Details

Novavax Reports First Quarter 2024 Financial
Results and Operational Highlights
GAITHERSBURG, Md., May 10, 2024 -
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced its
financial results and operational highlights for the first quarter ended March 31, 2024.
Earlier today, Novavax and Sanofi (NASDAQ: SNY)
announced that they have entered into a co-exclusive licensing agreement. The terms of the agreement include: a co-exclusive license to
co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance
Purchase Agreements [APAs] and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax's
adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines while Novavax retains the right to and is developing
its own COVID-19-Influenza Combination (CIC) vaccine candidate; a non-exclusive license to use Novavax's adjuvanted COVID-19 vaccine
for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition,
Sanofi will take a minority (<5%) equity investment in Novavax.
"Today we announce the beginning of an exciting
new chapter for Novavax with the launch of a strategically important partnership with one of the world's leading vaccine companies.
We believe the combined strength of Novavax and Sanofi will enable us to better fulfill our mission of developing and improving access
to life-saving vaccines," said John C. Jacobs, President and Chief Executive Officer, Novavax. "I am proud of the progress
our Company has made this quarter as we continue to advance our COVID-19 vaccine for the upcoming 2024-2025 vaccination season and plan
for the launch of our Phase 3 CIC and standalone influenza program in the second half of this year."
The agreement is further validation of Novavax's
technology platform and provides significant opportunity to drive value creation and benefit global public health. It strengthens Novavax's
balance sheet and cash flow position, providing the opportunity to focus more on research and development and pipeline expansion to accelerate
growth and generate long-term value for shareholders.
Sanofi Agreement Highlights
Financial Highlights
Additional Highlights
First Quarter 2024 and Recent Highlights
During the first quarter, Novavax continued executing
against its three key priorities for 2024.
Priority #1: Deliver an Updated COVID-19
Vaccine for the 2024-2025 Vaccination Season
Priority #2: Launch Phase 3 trial of CIC
and Stand-alone Influenza Program
Novavax remained focused on leveraging its technology
platform, including its proprietary Matrix-M adjuvant, to expand its pipeline with CIC and stand-alone influenza vaccine candidates.
Priority #3: Continue Evolution of Novavax,
Further Reducing Operating Expenses
Novavax has made significant progress on its commitment
to improve its financial position while maintaining the capabilities that support long-term value creation.
First Quarter 2024 Financial Results
Novavax is updating its Full Year 2024 Financial
Guidance and expects to achieve the following objectives:
Full Year 2024 Guidance
$ in millions Prior (as of February 28, 2024) Updated (as of May 10, 2024)
Combined Revenue and Sanofi Agreement Payments $800 - $1,000 $970 - $1,170
Total Revenue 1,2 $800 - $1,000 $400 - $600
Initial Sanofi Agreement Payments 3 ~$570
Combined R&D and SG&A $700 - $800 $700 - $750
Total potential contract value for APAs outstanding,
as of March 31, 2024, was over $600 million related to expected dose deliveries for the second quarter of 2024 through 2026. This amount
excludes deferred revenue associated with the 2023 Canada amendments to forfeit doses.
Novavax is prepared to initiate an additional
cost reduction program to reduce 2025 R&D plus SG&A expenses to below $500 million, a portion of which it expects to be reimbursed
by Sanofi under the agreement. This reflects a greater than $225 million reduction beyond prior stated targets.
reshape the size and scope of global business operations to prioritize enabling Sanofi to successfully execute its commercial and
development plans under the agreement, deliver on existing Novavax APAs and focus on creating value from R&D and business development.
Novavax will host its quarterly conference call
today at 8:30 a.m. ET. To join the call without operator assistance, you may register and enter your phone number at https://emportal.ink/3VNP8J5 to
receive an instant automated call back. You may also dial direct to be entered to the call by an operator. The dial-in numbers for the
conference call are (888) 664-6383 (Domestic) or (+1) (416) 764-8650 (International). Participants will be prompted to request to join
the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. EST on May 10, 2024, until 11:59 p.m.
ET on May 17, 2024. To access the replay by telephone, dial (888) 390-0541 (Domestic) or (+1) (416) 764-8677 (International) and use
A webcast of the conference call can also be
accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until
Trade Name in the U.S.
The trade name Nuvaxovid has not been approved
Novavax, Inc. (Nasdaq: NVAX) promotes improved
health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax,
a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach,
innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio
includes its COVID-19 vaccine and its pipeline includes CIC and stand-alone influence vaccine candidates. In addition, Novavax's
adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and
LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its mission, its near-term priorities including delivering an updated COVID-19 vaccine for the start of the 2024-2025 vaccination season
in a pre-filled syringe presentation, launching a Phase 3 trial for CIC and stand-alone influenza in the second half of 2024, with possible
combination vaccine and stand-alone influenza vaccine launch in 2026, and reducing operations expenses, including by initiating an additional
cost reduction program, the anticipated timing of potential BLA approval for Novavax's prototype vaccine and EUA for Novavax's
updated COVID-19 vaccine, potential royalties and milestones under the agreement with Sanofi, its operating plans, objectives and prospects,
updated full year 2024 financial guidance, its future financial or business performance, conditions or strategies, and its ability to
attain contract value under existing APAs 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, Novavax's and Sanofi's ability to successfully implement
its partnership, including the ability to transition key processes and effect technology transfers, Novavax's ability to successfully
and timely manufacture, distribute, or market its updated COVID-19 vaccine including as a single dose vial or pre-filled syringe product
presentation for the 2024-2025 vaccination season; challenges satisfying, alone or together with partners, various safety, efficacy,
and product characterization requirements, including those related to process qualification, assay validation and stability testing,
necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials; challenges or delays in obtaining
regulatory authorization for its product candidates, including its updated COVID-19 vaccine in time for the 2024-2025 vaccination season
or for future COVID-19 variant strain changes, its CIC and stand-alone influenza vaccine candidate; manufacturing, distribution or export
delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation
and filling and PCI Pharma Services for finishing Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their
operations on the delivery of customer orders; difficulty obtaining scarce raw materials and supplies; resource constraints, including
human capital and manufacturing capacity, constraints on Novavax's ability to pursue planned regulatory pathways, alone or with
partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; challenges
in implementing its global restructuring and cost reduction plan; Novavax's ability to timely deliver doses; challenges in obtaining
commercial adoption and market acceptance of its updated COVID-19 vaccine or any COVID-19 variant strain containing formulation; challenges
meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements
to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future
payments pursuant to such agreements; challenges related to the seasonality of vaccinations against COVID-19; 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's Annual Report on Form 10-K for the year ended December 31, 2023 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

Frequently Asked Questions

What major partnership did Novavax announce recently?

Novavax announced a co-exclusive licensing agreement with Sanofi.

What is the expected revenue for Novavax in 2024?

Novavax updated its 2024 revenue guidance to $970 - $1,170 million.

What are Novavax's key priorities for 2024?

Novavax's priorities include delivering an updated COVID-19 vaccine and launching trials.

How much does Novavax aim to reduce its R&D expenses by 2025?

Novavax plans to reduce its R&D expenses to below $500 million by 2025.

What vaccine technology does Novavax utilize?

Novavax uses a protein-based vaccine technology combined with its Matrix-M adjuvant.

Last updated: May 10, 2024