Novavax Reports First Quarter 2026 Financial Results and Operational Highlights
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Total revenue of
$140 million in the first quarter of 2026 - Pfizer agreement announced in January for non-exclusive license to utilize Matrix-M® in two infectious disease areas
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In April,
signed a new MTA with a top 10 leading pharmaceutical company and leader in oncology to explore Matrix-M in multiple oncology and infectious disease targetsNovavax -
In April,
Novavax expanded an existing partnership with a new MTA, providing access to Matrix-M for exploration in up to nine additional identified infectious diseases -
In February,
Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an oncology company - Sanofi announced positive results from the Phase 4 COMPARE study, a head-to-head study comparing Nuvaxovid™ and Moderna's mNEXSPIKE that reinforces Nuvaxovid's well established and differentiated reactogenicity profile
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Novavax's C. difficile vaccine candidate prioritized with potential to enter the clinic as early as 2027 - Reiterates 2026 Revenue Framework and Combined R&D and SG&A expense guidance
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First Quarter 2026 and Recent Highlights
Key Business Highlights
- In
January 2026 , Novavax entered into a license agreement with Pfizer for use of Novavax's Matrix-M adjuvant in vaccine development. Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M use in two infectious disease areas.- Novavax received an upfront payment of
$30 million in the first quarter of 2026 and has the potential for up to$500 million in additional development and sales milestones. In addition, Novavax is eligible to receive high-mid-single digit percentage royalties on sales from products incorporating Matrix-M. - Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M, and Novavax will be responsible for the supply of Matrix-M.
- This partnership has the potential to generate billions of dollars of revenue for
Novavax over the life of the agreement.
- Novavax received an upfront payment of
- In 2026,
Novavax continued to expand its Matrix-M partnering efforts with global pharmaceutical companies and innovative biopharma companies.- In April,
Novavax signed a new material transfer agreement (MTA) with a top ten global pharmaceutical company who is also a global leader in oncology to explore Matrix-M in a broad array of oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases. - In April,
Novavax signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M in nine additional, identified disease areas. - In February,
Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.
- In April,
- In total,
Novavax now has MTA collaborations and/or license agreements with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the right to explore Matrix-M in over 30 unique fields of experimentation across both infectious diseases and oncology.- The goal of
Novavax's MTA collaborations is to enable exploration of Matrix-M with the intent of entering into deeper partnership via formal license agreements, that in turn results in the advancement of a partner's research and development (R&D) clinical work toward the potential commercialization of innovative vaccines. - The broad utility of
Novavax's technology has resulted in several companies exploring Matrix-M for application in the same high-potential markets, including infectious disease areas such as cytomegalovirus, Epstein-Barr Virus, pneumococcal and respiratory syncytial virus (RSV); and also includes overlap in oncology areas such as colorectal cancer, head and neck cancer and pancreatic cancer. - Existing partners under license and MTA agreements, have the right to address fields of experimentation that cover over 50% of the global market opportunity for infectious disease and oncology vaccines and immuno-therapeutics, which is projected to grow to over
$100 billion by the early 2030s.
- The goal of
- In April, Sanofi announced positive Phase 4 results from the COMPARE study, a head-to-head study showing that Nuvaxovid™ demonstrated statistically significant lower side effects compared to Moderna's mNEXSPIKE across all pre-specified endpoints, reinforcing Nuvaxovid's well-established and differentiated reactogenicity profile ahead of the fall season.
- Continued to progress Novavax R&D innovation in support of its growth strategy.
- Clostridioides difficile colitis (C. difficile) vaccine candidate prioritized as potential next asset to enter the clinic as early as 2027.
- Preliminary preclinical data generated by
Novavax on its varicella-zoster virus (shingles) and RSV early-stage assets were positive and provide path forward for informing the Company's future antigen design and adjuvant work. - Ongoing adjuvant research is intended to expand the utility of its technology by creating new adjuvants tailored to foster specific differentiated immune properties for certain diseases that may require unique immune responses.
- Novavax continued to progress its cost reduction program to create a more lean and agile organization.
- Targeting full year Non-GAAP combined R&D and Selling, General and Administrative (SG&A) expenses of
$325 million for full year 2026 and $225 million for full year 2027, each period at the midpoint of the guidance range. - Improving the 2028 target for full year Non-GAAP combined R&D and SG&A expenses to between
$150 million and$200 million . This reflects an anticipated expense reduction of over$200 million and over 50% when compared to full year 2025.
- Targeting full year Non-GAAP combined R&D and Selling, General and Administrative (SG&A) expenses of
First Quarter 2026 Total Revenue
First quarter 2025 Nuvaxovid sales included
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First Quarter |
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$ in millions |
Q1 2026 |
Q1 2025 |
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Change |
% |
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Nuvaxovid Sales1 |
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|
|
( |
(98 %) |
|
Supply Sales 2 |
33 |
14 |
|
19 |
139 % |
|
Product Sales |
42 |
622 |
|
(579) |
(93 %) |
|
|
|
|
|
|
|
|
Sanofi3 |
49 |
40 |
|
9 |
21 % |
|
Pfizer
Takeda |
30 |
0 |
|
30 |
NM |
|
Serum |
7 |
4 |
|
3 |
65 % |
|
Other Partners 4 |
11 |
0 |
|
11 |
NM |
|
Licensing, Royalties and |
97 |
45 |
|
52 |
116 % |
|
|
|
|
|
|
|
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Total Revenue |
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|
|
( |
(79 %) |
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Notes |
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1. |
Nuvaxovid Sales reflects product sales where |
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2. |
Supply Sales includes sales of finished product, adjuvant and other supplies from |
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3. |
Sanofi includes revenue recognized under the license agreement including upfront payments, milestones, royalties and transition services reimbursement. |
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4. |
Other Partners include upfront payments, royalties and milestone revenue under licensing agreements including Takeda and SK bioscience. |
First Quarter 2026 Financial Results
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Total revenue for the first quarter of 2026 was
$140 million , a 79% decrease compared to$667 million in the same period in 2025. Higher Nuvaxovid product sales for the first quarter of 2025 were primarily due to$603 million of non-cash sales revenue recognized with the close-out of two APAs. Licensing Royalties and Other revenue of$97 million in the first quarter of 2026 included$30 million related to the Pfizer Matrix-M agreement signed inJanuary 2026 . -
Cost of sales for the first quarter of 2026 was
$31 million , compared to$14 million in the same period in 2025. -
R&D expenses for the first quarter of 2026 were
$95 million , compared to$89 million in the same period in 2025. The higher R&D costs were primarily associated with COVID-19 postmarketing commitment studies and annual strain change activities. R&D expenses reimbursed by partners in the first quarter of 2026 were $28 million. Non-GAAP R&D expenses, net of partner reimbursement, were$68 million in the first quarter of 2026, a 13% decrease when compared to$78 million in the same period in 2025. The lower Non-GAAP R&D expenses were driven by the ongoingNovavax cost reduction program as it streamlines operations to make targeted R&D investments. -
SG&A expenses for the first quarter of 2026 were
$29 million , a 40% decrease compared to$48 million for the same period in 2025. The decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus the ongoing general administrative cost reduction program. -
Net Loss for the first quarter of 2026 was
$9 million , compared to net income of$519 million in the same period in 2025. First quarter of 2025 net income benefited from$603 million of non-cash sales related to the close-out of two APA agreements. -
Cash, cash equivalents, marketable securities and restricted cash
(Cash) were
$795 million as ofMarch 31, 2026 , compared to$751 million as ofDecember 31, 2025 . InFebruary 2026 ,Novavax announced a$330 million credit facility withMidCap Financial , including an initial capital draw of$50 million . The credit facility was put in place to further strengthenNovavax's balance sheet and provide access to non-dilutive capital asNovavax advances its growth strategy.
Financial Framework
Reiterates Full Year 2026 Financial Guidance
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$ in millions |
Full Year 2026
(as of |
|
Combined R&D and SG&A Expenses |
|
|
Less: R&D Reimbursements |
( |
|
Non-GAAP Combined R&D and SG&A Expenses |
|
Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by
Reiterates Full Year 2026 Revenue Framework
For 2026,
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$ in millions |
Full Year 2026
(as of |
|
|
Nuvaxovid Product Sales1 |
|
|
|
Adjusted Supply Sales2 |
|
|
|
|
|
|
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Adjusted Total Revenue4 |
|
|
|
|
|
|
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Sanofi Supply Sales, Sanofi Royalties and Sanofi Milestones |
No guidance |
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|
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Revenue Category |
Revenue Framework Footnotes |
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Nuvaxovid Product Sales1 |
|
|
Adjusted Supply Sales2 |
|
|
|
|
|
Adjusted Total Revenue4 |
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Components of Revenue excluded from the Full Year 2026 Revenue Framework are described below.
Sanofi Supply Sales
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Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2026-2027 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales.
Sanofi Royalties
- Sanofi will lead commercial activities for the 2026-2027 COVID-19 vaccination season in select markets, including the
U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales.
Sanofi Milestones
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Novavax is eligible to receive a$75 million milestone payment related to the completion of the technology transfer of the Nuvaxovid manufacturing process to Sanofi. -
Novavax is eligible to receive up to$350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi influenza-COVID-19 combination products. - For each new vaccine using Matrix-M,
Novavax is eligible to receive up to$200 million in launch and sales milestones and mid-single digit sales royalties for 20 years.
Conference Call
A webcast of the conference call can also be accessed on the
About
Non-GAAP Financial Measures
The Company presents the following non-GAAP financial measures in this press release: Non-GAAP Combined R&D and SG&A Expenses, Adjusted Total Revenue and
Forward-Looking Statements
This press release contains forward-looking statements relating to the future of
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share information) |
|||
|
|
|
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|
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Three Months Ended |
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|
|
2026 |
|
2025 |
|
|
(unaudited) |
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Revenue: |
|
|
|
|
Product Sales |
42,200 |
|
621,678 |
|
Licensing, royalties and other |
97,314 |
|
44,977 |
|
Total revenue |
139,514 |
|
666,655 |
|
|
|
|
|
|
Expenses |
|
|
|
|
Cost of Sales |
30,695 |
|
14,115 |
|
Research and Development |
95,472 |
|
88,937 |
|
Selling, general, and administrative |
28,777 |
|
48,090 |
|
Total expenses |
154,944 |
|
151,142 |
|
Income (loss) from operations |
(15,430) |
|
515,513 |
|
Other income (expense): |
|
|
|
|
Interest expense |
(4,901) |
|
(5,723) |
|
Other income, net |
11,825 |
|
10,056 |
|
Income (loss) before income tax expense |
(8,506) |
|
519,846 |
|
Income tax expense |
985 |
|
1,200 |
|
Net income (loss) |
(9,491) |
|
518,646 |
|
|
|
|
|
|
Net income (loss) per share |
|
|
|
|
Basic |
(0.06) |
|
3.22 |
|
Diluted |
(0.06) |
|
2.93 |
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|||
|
Basic |
163,276 |
|
161,049 |
|
Diluted |
163,276 |
|
177,625 |
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SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
Cash and cash equivalents |
228,363 |
|
240,634 |
|
Marketable securities |
561,969 |
|
494,450 |
|
Total restricted cash |
4,562 |
|
15,418 |
|
Total current assets |
850,816 |
|
978,276 |
|
Working capital |
508,355 |
|
518,326 |
|
Total assets |
1,043,162 |
|
1,176,512 |
|
Convertible notes payable |
291,039 |
|
244,213 |
|
Total stockholder's deficit |
(144,762) |
|
(127,753) |
|
Reconciliation of GAAP to NON-GAAP Financial Results (unaudited) |
|||
|
|
|
|
|
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($ in millions) |
Three Months Ended
|
||
|
|
2026 |
|
2025 |
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Total Revenue |
139.5 |
|
666.7 |
|
Adjustments: |
|
|
|
|
Sanofi Supply Sales Adjustment |
17.1 |
|
1.2 |
|
Sanofi Royalties Adjustment |
3.5 |
|
0 |
|
Adjusted Total Revenue |
$ 118.9 |
|
$ 665.5 |
|
|
|
|
|
|
R&D Expenses |
95.5 |
|
88.9 |
|
Adjustments: |
|
|
|
|
R&D Reimbursement |
27.7 |
|
11.3 |
|
Non-GAAP R&D Expenses |
$ 67.8 |
|
$ 77.6 |
|
|
|
|
|
|
Combined R&D and SG&A Expenses |
124.3 |
|
137.0 |
|
Adjustments: |
|
|
|
|
R&D Reimbursement |
27.7 |
|
11.3 |
|
Non-GAAP Combined R&D and SG&A Expenses |
$ 96.6 |
|
$ 125.7 |
Contacts:
Investors
844-668-2829
ir@novavax.com
Media
844-264-8571
media@novavax.com
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