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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
May 10, 2024
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
| Delaware |
|
0-26770 |
|
22-2816046 |
|
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
700 Quince Orchard Road
Gaithersburg, Maryland 20878
(Address of Principal Executive Offices,
including Zip Code)
(240) 268-2000
(Registrant’s telephone number,
including area code)
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered |
| Common Stock, Par Value $0.01 per share |
|
NVAX |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition.
Fourth Quarter Financial Results
On May 10,
2024, Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter
ended March 31, 2024. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
Novavax, Inc. |
| |
|
|
| Date: May 10, 2024 |
By: |
/s/ Mark J. Casey |
| |
Name: |
Mark J. Casey |
| |
Title: |
Executive Vice President, Chief Legal Officer and Corporate Secretary |
Exhibit 99.1
| Press Release | |
 |
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 combination vaccines and develop multiple new vaccines utilizing Novavax’s Matrix-MTM
adjuvant |
| · | This agreement represents a potential multi-billion
dollar revenue opportunity for Novavax including: |
| o | $500 million upfront payment |
| o | Approximately $70 million equity investment in Novavax |
| o | Up to $700 million in COVID-19 and combination product near-term milestones, plus ongoing tiered royalties on product sales |
| o | Up to $200 million in milestones plus royalties for each new vaccine developed utilizing Novavax’s Matrix-MTM
adjuvant |
| · | Announces addition of standalone influenza vaccine to Phase 3 COVID-19-Influenza
Combination vaccine trial, which is on-track to initiate second half of 2024, with potential 2026 launch for both candidates |
| · | Reduced current liabilities by an additional $831 million during Q1 2024 |
| · | Achieved total revenue in Q1 2024 of $94 million |
| · | Novavax removes going concern notice |
| · | Company to host conference call today at 8:30
a.m. ET |
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
| · | This agreement represents a potential multi-billion
dollar revenue opportunity for Novavax. |
| · | The total value of near-term upfront payments,
Sanofi’s equity investment and potential milestones associated with Nuvaxovid™ sales and the development of Sanofi’s
flu-COVID-19 combination vaccine equate to approximately $1.3 billion. |
| o | Novavax will receive an upfront payment of $500 million within 10 days. |
| o | Novavax will receive today an equity investment of approximately $70 million in Novavax common stock for
a 4.9% minority interest. |
| o | Novavax is eligible to receive up to $350 million in milestones for activities related to Nuvaxovid. |
| o | Novavax is eligible to receive up to $350 million in additional milestones for Sanofi’s flu-COVID-19
combination vaccine. |
| · | In addition, Novavax is eligible to receive royalties
associated with the ongoing sales of Nuvaxovid and Sanofi’s flu-COVID-19 combination vaccine and any other combination vaccines
Sanofi may develop including Nuvaxovid. |
| · | And finally, for each additional Sanofi vaccine
product developed under the non-exclusive license with Novavax’s Matrix-M adjuvant technology, Novavax is eligible to receive additional
launch and sales milestones of up to $200 million per product plus ongoing product royalties. |
Additional Highlights
| · | Novavax is eligible for cost reimbursement by
Sanofi of certain R&D and medical affairs costs, select technology transfer costs and supply of COVID-19 and Matrix-M adjuvant. |
| · | Sanofi will be solely responsible for the development
and commercialization of any novel flu-COVID-19 combination product containing a Sanofi flu vaccine, and any other combination products
they may develop utilizing Nuvaxovid and any other new vaccines they develop utilizing the Matrix-M adjuvant. |
| · | Outside of the collaboration, each party may
develop and commercialize their own COVID-19-Influenza combination vaccines and adjuvanted products at their own cost. |
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
U.S. Market:
| · | Updated protein-based COVID-19 vaccine to JN.1
with anticipated pre-filled syringe presentation. |
| · | Completed the submission of the Biologics License
Application for Novavax's COVID-19 vaccine with the U.S. Food and Drug Administration (FDA). |
| · | Aligned with the FDA on pathway for Emergency
Use Authorization for updated COVID-19 vaccine for the 2024-2025 vaccination season, with the intent of facilitating product availability
at the beginning of the season. |
| · | Advanced retail pharmacy contract negotiations
for the 2024-2025 vaccination season. |
Global Markets:
| · | Delivered doses of Nuvaxovid XBB.1.5 vaccine
to Europe and for distribution by the Taiwan Centers for Disease Control. |
| · | Received marketing authorization from the United
Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency for Nuvaxovid XBB.1.5 in individuals aged 12 and older in January
and progressed preparations for participation in the U.K. spring campaign for private healthcare providers. |
| · | Granted full approval from Singapore’s
Health Sciences Authority for Nuvaxovid XBB.1.5 for active immunization to prevent COVID-19 in individuals aged 12 and older. |
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.
| · | Made strategic decision to add a stand-alone
influenza arm to the Phase 3 trial and to focus on individuals at higher risk by enrolling adults aged 60 and older for both the stand-alone
influenza and CIC arms of the trial. |
| · | On track to submit an investigational new drug
application and initiate the pivotal Phase 3 trial for both CIC and stand-alone influenza vaccine candidates in the second half of 2024,
with potential for accelerated approval and launch in 2026. |
| · | Continued to optimize preclinical candidates,
including a new approach to H5N1 pandemic bird flu vaccination, and expanded core technology for novel applications including mucosal
vaccination and high-density nanoparticles. |
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.
| · | On track with global restructuring and cost reduction
plan, continued to transform the Company into a more lean and agile organization, with an approximately 50% reduction in combined R&D
and SG&A expenses in the first quarter of 2024 compared to 2023. |
| · | Since December 31, 2022, reduced current liabilities
by $1.7 billion, including an additional $831 million reduction in the first quarter of 2024, primarily driven by the settlements with
Gavi, the Vaccine Alliance and Fujifilm Diosynth Biotechnologies. |
First Quarter 2024 Financial Results
| · | Total revenue for the first quarter of
2024 was $94 million, compared to $81 million in the same period in 2023. |
| · | Cost of sales for the first quarter of
2024 was $59 million, compared to $34 million in the same period in 2023. These quarters included $15 million and $25 million, respectively,
related to excess, obsolete or expired inventory, losses on firm purchase commitments under third-party supply agreements and unutilized
manufacturing capacity. |
| · | R&D expenses
for the first quarter of 2024 were $93 million, compared to $247 million in the same period in 2023. The decrease was primarily due
to reductions in manufacturing and clinical research-related spend as well as a $27 million benefit associated with the favorable settlement
of manufacturing liabilities recorded in the first quarter of 2024. |
| · | SG&A expenses
for the first quarter of 2024 were $87 million, compared to $113 million for the same period in 2023. The decrease was primarily due
to the Company's continued cost containment measures to reduce operating spend. |
| · | Net loss for the first quarter 2024 was
$148 million, compared to a net loss of $294 million in the same period in 2023. |
| · | Cash, cash equivalents and restricted cash
were $496 million as of March 31, 2023, compared to $584 million as of December 31, 2023. |
Financial Framework
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
Revenue1,2 |
$800 - $1,000 |
$400 - $600 |
| Initial
Sanofi Agreement Payments3 |
|
~$570 |
| |
|
|
| Combined R&D and SG&A |
$700 - $800 |
$700 - $750 |
| 1. | Total Revenue includes product sales and royalties and other revenue. |
| 2. | Full year 2024 guidance reflects APA expected dose delivery schedules of $150 million to $250 million and non-APA related revenue
of $250 million to $350 million, subject to updated variant manufacturing and regulatory approvals, from a combination of commercial market
product sales plus royalties and other revenue from partner-related activity. The update to the expected 2024 APA dose delivery schedules
reflects the anticipated shift of approximately $250 million in contracted doses from 2024 to future periods. |
| 3. | Sanofi agreement initial payments include a non-refundable $500 million upfront payment to be received within 10 days and an immediate
$69 million equity investment in Novavax. |
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.
Intends to further
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.
Conference Call
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
passcode 414036 #.
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
June 10, 2024.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not been approved
by the U.S. FDA.
About Novavax
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
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
| | |
Three Months Ended
March 31, | |
| | |
2024 | | |
2023 | |
| | |
| | |
| |
| | |
(unaudited) | |
| Revenue: | |
| | | |
| | |
| Product sales | |
$ | 82,324 | | |
$ | (7,457 | ) |
| Grants | |
| -- | | |
| 87,379 | |
| Royalties and other | |
| 11,531 | | |
| 1,029 | |
| Total revenue | |
| 93,855 | | |
| 80,951 | |
| Expenses: | |
| | | |
| | |
| Cost of sales | |
| 59,209 | | |
| 34,086 | |
| Research and development | |
| 92,679 | | |
| 247,101 | |
| Selling, general and administrative | |
| 86,798 | | |
| 112,532 | |
| Total expenses | |
| 238,686 | | |
| 393,719 | |
| Loss from operations | |
| (144,831 | ) | |
| (312,768 | ) |
| Interest expense | |
| (4,111 | ) | |
| (4,316 | ) |
| Other income | |
| 3,654 | | |
| 24,362 | |
| Loss before income taxes | |
| (145,288 | ) | |
| (292,722 | ) |
| Income tax expense | |
| 2,262 | | |
| 1,183 | |
| Net loss | |
$ | (147,550 | ) | |
$ | (293,905 | ) |
| Net loss per share Basic and Diluted | |
$ | (1.05 | ) | |
$ | (3.41 | ) |
| Weighted average number of common shares outstanding Basic and Diluted | |
| 139,916 | | |
| 86,158 | |
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
| | |
March 31,
2024 | | |
December 31,
2023 | |
| | |
(unaudited) | | |
| |
| Cash and cash equivalents | |
$ | 480,586 | | |
$ | 568,505 | |
| Total restricted cash | |
| 15,350 | | |
| 15,305 | |
| Total current assets | |
| 727,120 | | |
| 1,143,888 | |
| Working capital | |
| (77,262 | ) | |
| (491,250 | ) |
| Total assets | |
| 1,353,534 | | |
| 1,794,490 | |
| Convertible notes payable | |
| 168,432 | | |
| 168,016 | |
| Total stockholders’ deficit | |
| (867,084 | ) | |
| (716,927 | ) |
Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
202-709-5563
media@novavax.com
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- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
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-Section 13e
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| X |
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-Publisher SEC
-Name Exchange Act
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-Section 14d
-Subsection 2b
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| Namespace Prefix: |
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| Data Type: |
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| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
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| Namespace Prefix: |
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| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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| Namespace Prefix: |
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| Balance Type: |
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| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
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| Namespace Prefix: |
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| Data Type: |
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| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
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| Namespace Prefix: |
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| Period Type: |
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| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
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| Namespace Prefix: |
dei_ |
| Data Type: |
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