Novavax Reports Second Quarter 2024 Financial Results and Operational Highlights
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Achieved total revenue of
$415 million in the second quarter of 2024 and ended the period with$1.1 billion in Cash - Filed with the U.S. FDA and EMA for authorization of updated 2024-2025 formula COVID-19 vaccine
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Received
$570 million in upfront payment and equity investment from Sanofi; progressed operationalization of Sanofi partnership - Phase 3 trial initiation for COVID-19-Influenza Combination and stand-alone influenza vaccines planned for Q4 2024; data expected by mid-2025
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Company to host conference
call today at
8:30 a.m. ET
"This is an exciting time for
Second Quarter 2024 and Recent Highlights
During the second quarter,
Priority #1: Successful Execution of
- Effective
January 1, 2025 , Sanofi will assume primary commercial responsibility forNovavax's updated 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) in theU.S. ,Europe and select major markets not currently subject to Novavax Advance Purchase Agreements (APAs) or existing partnership agreements. - Received
$500 million upfront payment and an approximately$70 million equity investment from Sanofi. -
Novavax is eligible to receive up to$700 million in development, regulatory and launch milestones for activities related to commercializing Nuvaxovid™ and advancing Sanofi's flu-COVID-19 combination vaccine candidate plus royalties. In addition,Novavax is eligible to receive royalties associated with any other Nuvaxovid combination vaccine Sanofi chooses to develop. - 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$210 million per product plus ongoing product royalties.
Priority #2: Drive Incremental Value from
- On track to initiate the Phase 3 immunogenicity trial for both COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates in the fourth quarter of 2024, with data expected by mid-2025.
- Conducting pipeline prioritization activities to determine Novavax's lead portfolio programs.
Priority #3: Continue Evolution of
- On track with global restructuring and cost reduction plan with an approximately 34% reduction in combined R&D and Selling, General and Administrative (SG&A) expenses in the second quarter of 2024 compared to the same period for 2023.
- Prepared to initiate an additional cost reduction program to reduce R&D plus SG&A expenses, with a portion of expenses to be reimbursed by Sanofi under the Sanofi Agreement.
Novavax plans to continue assessing existing capabilities to further refine the shape, size and scope of its organization this year and into 2025. - Targeting full year combined R&D and SG&A expenses to be below
$500 million for full year 2025 and below$350 million for full year 2026.Novavax expects greater than$50 million of such expenses in 2025 to be reimbursed by Sanofi under the Sanofi Agreement, resulting in adjusted combined R&D and SG&A expenses, net of Sanofi reimbursement costs under the Sanofi Agreement, of below$450 million for full year 2025.
Priority #4: Deliver an Updated COVID-19 Vaccine for the 2024-2025 Vaccination Season
U.S. Market:
- Submitted an Emergency Use Authorization (EUA) amendment to the
U.S. Food and Drug Administration (FDA). - Advanced manufacturing of pre-filled syringe presentation of updated 2024-2025 formula COVID-19 vaccine following FDA strain selection guidance. Expect doses will be ready to ship upon receipt of EUA.
- FDA accepted the Biologics License Application (BLA) for
Novavax's COVID-19 vaccine with a Prescription Drug User Fee Act date ofApril 2025 . - Advanced retail pharmacy contract negotiations to enhance access for the 2024-2025 vaccination season.
Global Markets:
- For 2024, made decision to conduct lean and targeted commercial launch in
Europe in select key countries includingGermany ,Italy andPoland . - Submitted marketing authorization amendments to the
European Medicines Agency (EMA) and expect doses will be ready to ship upon receipt of market authorization.
Second Quarter 2024 Financial Results
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Total revenue for the second quarter of 2024 was
$415 million , compared to$424 million in the same period in 2023. Second quarter 2024 licensing, royalties and other revenue includes$391 million associated with the$500 million upfront payment received under the Sanofi Agreement. -
Cost of sales for the second quarter of 2024 was
$46 million , compared to$56 million in the same period in 2023. These quarters included$24 million and$31 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 second quarter of 2024 were
$107 million , compared to$219 million in the same period in 2023. The decrease was primarily due to reductions in manufacturing and clinical research-related spend. -
SG
&A expenses for the second quarter of 2024 were
$101 million , compared to$94 million for the same period in 2023. The increase was primarily due to certain fees paid in association with signing the Sanofi Agreement. -
Net income for the second quarter 2024 was
$162 million , compared to a net income of$58 million in the same period in 2023. -
Cash, cash equivalents, marketable securities and restricted cash (Cash) were
$1.1 billion as ofJune 30, 2024 , compared to$584 million as ofDecember 31, 2023 .
Financial Framework
Full Year 2024 Guidance
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Reflects revenue recognition |
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$ in millions |
Prior
(as of |
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Updated
(as of |
Combined Revenue and Sanofi |
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Total Revenue |
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Total Revenue1 |
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Product Sales3 |
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Initial Sanofi Agreement |
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Licensing, Royalties and Other |
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Combined R&D and SG&A |
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Combined R&D and SG&A5 |
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Prior full year 2024 Total Revenue guidance includes product sales, royalties and other revenue and did not reflect revenue attributable to the initial payments received from Sanofi pursuant to the Sanofi Agreement in the second quarter of 2024. Prior full year 2024 Total Revenue 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 activities. -
Initial Sanofi Agreement payments received in the second quarter of 2024 include a non-refundable
$500 million upfront payment and a$69 million equity investment inNovavax . -
Full year 2024 product sales guidance reflects approximately
$100 million in APA dose deliveries in 1H 2024 and$175 million to$275 million of commercial market sales expected in 2H 2024, subject to updated variant manufacturing and regulatory approvals. -
Full year 2024 guidance for Licensing, royalties and other revenue includes
$400 million of revenue recognition from the$500 million Sanofi agreement upfront payment and$25 million in royalty and other revenue from partner-related activities. - Combined R&D and SG&A expenses expected at the higher end of the range to account for the Sanofi Agreement transaction costs.
Conference Call
A webcast of the conference call can also be accessed on the
The trade name Nuvaxovid has not been approved by the
About
Non-GAAP Financial Measures
The Company has used a non-GAAP financial measure in this press release, which is adjusted combined R&D and SG&A expenses, net of Sanofi reimbursement costs under the Sanofi Agreement. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in
Forward-Looking Statements
Statements herein relating to the future of Novavax, its mission, its near-term priorities including a successful transition under the Sanofi partnership, driving incremental value from
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Three Months Ended |
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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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(unaudited) |
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(unaudited) |
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Revenue: |
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Product sales |
$ 19,904 |
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$ 285,163 |
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$ 102,228 |
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$ 277,706 |
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Licensing, royalties and other |
395,580 |
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2,184 |
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407,111 |
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3,213 |
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Grants |
-- |
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137,079 |
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-- |
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224,458 |
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Total revenue |
415,484 |
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424,426 |
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509,339 |
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505,377 |
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Expenses: |
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Cost of sales |
46,242 |
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55,777 |
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105,451 |
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89,863 |
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Research and development |
106,946 |
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219,475 |
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199,625 |
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466,576 |
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Selling, general and administrative |
101,298 |
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93,717 |
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188,096 |
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206,249 |
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Total expenses |
254,486 |
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368,969 |
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493,172 |
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762,688 |
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Income (loss) from operations |
160,998 |
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55,457 |
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16,167 |
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(257,311) |
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Interest expense |
(4,143) |
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(3,124) |
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(8,254) |
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(7,440) |
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Other income, net |
7,731 |
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5,532 |
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11,385 |
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29,894 |
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Income (loss) before income tax |
164,586 |
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57,865 |
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19,298 |
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(234,857) |
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Income tax expense (benefit) |
2,205 |
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(143) |
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4,467 |
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1,040 |
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Net income (loss) |
$ 162,381 |
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$ 58,008 |
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$ 14,831 |
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$ (235,897) |
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Net income (loss) per share: |
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Basic |
$ 1.09 |
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$ 0.65 |
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$ 0.10 |
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$ (2.69) |
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Diluted |
$ 0.99 |
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$ 0.58 |
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$ 0.10 |
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$ (2.69) |
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Weighted average number of common |
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Basic |
148,379 |
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89,362 |
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144,147 |
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87,769 |
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Diluted |
165,855 |
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104,065 |
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145,121 |
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87,769 |
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SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) |
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2024 |
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2023 |
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(unaudited) |
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Cash and cash equivalents |
$ 680,162 |
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$ 568,505 |
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Marketable securities |
369,432 |
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-- |
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Total restricted cash |
15,396 |
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15,305 |
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Total current assets |
1,203,370 |
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1,143,888 |
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Working capital |
45,559 |
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(491,250) |
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Total assets |
1,818,646 |
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1,794,490 |
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Convertible notes payable |
168,848 |
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168,016 |
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Total stockholders' deficit |
(431,706) |
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(716,927) |
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Contacts:
Investors
240-268-2022
ir@novavax.com
Media
202-709-5563
media@novavax.com
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