GAITHERSBURG, Md., Aug. 8, 2024 /PRNewswire/ -- 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 second quarter ended June 30, 2024.
"This is an exciting time for Novavax, and we have been keenly focused on evolving our operating model to leverage our key drivers of value," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We intend to drive future value for the business through not only the Sanofi partnership, but also through our late-stage combination and influenza assets. We plan to unveil a new and expanded clinical pipeline by the end of this year and leverage both the pipeline and our proven technology to drive additional partnerships and deals and to ultimately drive significant, long-term value for our shareholders."
Second Quarter 2024 and Recent Highlights
During the second quarter, Novavax continued executing against its four key priorities for the remainder of 2024.
Priority #1: Successful Execution of Sanofi Partnership
Novavax has taken steps to enable a successful operationalization of the collaboration and license agreement (the Sanofi Agreement) with Sanofi Pasteur Inc. (Sanofi).
Priority #2: Drive Incremental Value from Novavax's Proven Technology Platform
Novavax continued to leverage its technology platform to drive value creation.
Priority #3: Continue Evolution of Novavax and Reduce Operating Expenses
Novavax continued to progress its cost reduction program to create a more lean and agile organization and accelerate its focus on Research and Development (R&D).
Priority #4: Deliver an Updated COVID-19 Vaccine for the 2024-2025 Vaccination Season
Novavax expects to deliver its updated 2024-2025 formula COVID-19 vaccine to the market by the start of the season.
U.S. Market:
Global Markets:
Second Quarter 2024 Financial Results
Financial Framework
Novavax is updating its Full Year 2024 Financial Guidance and expects to achieve the following objectives.
Full Year 2024 Guidance
Reflects revenue recognition | ||||
$ in millions | Prior (as of May 10, 2024) | Updated (as of August 8, 2024) | ||
Combined Revenue and Sanofi | $970 - $1,170 | Total Revenue | $700 - $800 | |
Total Revenue1 | $400 - $600 | Product Sales3 | $275 - $375 | |
Initial Sanofi Agreement | ~$570 | Licensing, Royalties and Other | ~$425 | |
Combined R&D and SG&A | $700 - $750 | Combined R&D and SG&A5 | $700 - $750 |
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/3XTduSS 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 (800) 836-8184 (Domestic) or (+1) (646) 357-8785 (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. ET on August 8, 2024, until 11:59 p.m. ET on August 15, 2024. To access the replay by telephone, dial (888) 660-6345 (Domestic) or (+1) (646) 517-4150 (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 September 8, 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.
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 the United States (GAAP). The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses this non-GAAP financial measure for business planning purposes and to consider underlying trends of its business, and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company's expenses in the same manner as the Company's management. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. The use of this non-GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures.
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 Novavax's technology platform, delivering an updated 2024-2025 formula 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 fourth quarter of 2024, with data expected by mid-2025, and reducing operations expenses, including by initiating an additional cost reduction program, the anticipated timing of potential BLA approval for Novavax's prototype COVID-19 vaccine and XBB COVID-19 vaccine and EUA for Novavax's updated 2024-2025 formula 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 commercial launch plans for the 2024-2025 vaccination season, its future financial or business performance, conditions or strategies, and the downsizing of commercial operations in Europe 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 2024-2025 formula COVID-19 vaccine including as a single dose vial or pre-filled syringe product presentation for the 2024-2025 vaccination season and its ability to receive a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's new partnership with Sanofi; 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, including for its proprietary adjuvant; 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 and additional cost reduction program; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its updated 2024-2025 formula 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 and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for 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, 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.
NOVAVAX, INC. | |||||||||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||||||||
June 30, | June 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Product sales | $ 19,904 | $ 285,163 | $ 102,228 | $ 277,706 | |||||||||||||||||||
Licensing, royalties and other | 395,580 | 2,184 | 407,111 | 3,213 | |||||||||||||||||||
Grants | -- | 137,079 | -- | 224,458 | |||||||||||||||||||
Total revenue | 415,484 | 424,426 | 509,339 | 505,377 | |||||||||||||||||||
Expenses: | |||||||||||||||||||||||
Cost of sales | 46,242 | 55,777 | 105,451 | 89,863 | |||||||||||||||||||
Research and development | 106,946 | 219,475 | 199,625 | 466,576 | |||||||||||||||||||
Selling, general and administrative | 101,298 | 93,717 | 188,096 | 206,249 | |||||||||||||||||||
Total expenses | 254,486 | 368,969 | 493,172 | 762,688 | |||||||||||||||||||
Income (loss) from operations | 160,998 | 55,457 | 16,167 | (257,311) | |||||||||||||||||||
Interest expense | (4,143) | (3,124) | (8,254) | (7,440) | |||||||||||||||||||
Other income, net | 7,731 | 5,532 | 11,385 | 29,894 | |||||||||||||||||||
Income (loss) before income tax |
164,586 |
57,865 |
19,298 |
(234,857) | |||||||||||||||||||
Income tax expense (benefit) | 2,205 | (143) | 4,467 | 1,040 | |||||||||||||||||||
Net income (loss) | $ 162,381 | $ 58,008 | $ 14,831 | $ (235,897) | |||||||||||||||||||
Net income (loss) per share: | |||||||||||||||||||||||
Basic | $ 1.09 | $ 0.65 | $ 0.10 | $ (2.69) | |||||||||||||||||||
Diluted | $ 0.99 | $ 0.58 | $ 0.10 | $ (2.69) | |||||||||||||||||||
Weighted average number of common | |||||||||||||||||||||||
Basic | 148,379 | 89,362 | 144,147 | 87,769 | |||||||||||||||||||
Diluted | 165,855 | 104,065 | 145,121 | 87,769 |
SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) | |||||
June 30, 2024 | December 31, 2023 | ||||
(unaudited) | |||||
Cash and cash equivalents | $ 680,162 | $ 568,505 | |||
Marketable securities | 369,432 | -- | |||
Total restricted cash | 15,396 | 15,305 | |||
Total current assets | 1,203,370 | 1,143,888 | |||
Working capital | 45,559 | (491,250) | |||
Total assets | 1,818,646 | 1,794,490 | |||
Convertible notes payable | 168,848 | 168,016 | |||
Total stockholders' deficit | (431,706) | (716,927) |
Contacts:
Investors
Erika Schultz
240-268-2022
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Media
Giovanna Chandler
202-709-5563
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Last Trade: | US$8.44 |
Daily Change: | 0.40 4.98 |
Daily Volume: | 4,311,595 |
Market Cap: | US$1.350B |
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