Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights
Rhea-AI Summary
Novavax (NVAX) reported Q3 2024 financial results with total revenue of $85 million, down from $187 million in Q3 2023. The company ended the quarter with $1 billion in cash and receivables. Key developments include FDA's removal of clinical hold on COVID-19-Influenza Combination vaccine candidates and authorization for updated 2024-2025 COVID-19 vaccine. The company updated its 2024 guidance, lowering total revenue expectations to $650-700 million from previous $700-800 million. Q3 net loss was $121 million, improving from $131 million loss in Q3 2023. Cost reduction efforts showed a 26% decrease in R&D and SG&A expenses compared to previous year.
Positive
- FDA removed clinical hold on COVID-19-Influenza Combination vaccine candidates
- 26% reduction in R&D and SG&A expenses compared to Q3 2023
- Strong cash position of $924 million as of September 30, 2024
- Net loss improved to $121 million from $131 million year-over-year
- Received FDA and EC authorization for updated COVID-19 vaccine
Negative
- Total revenue declined 54.5% to $85 million from $187 million in Q3 2023
- Lowered 2024 total revenue guidance to $650-700 million from $700-800 million
- Product sales guidance reduced to $175-225 million from $275-375 million
- $28 million in costs related to excess, obsolete inventory and unused capacity
News Market Reaction 1 Alert
On the day this news was published, NVAX declined 6.10%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
U.S. FDA removes clinical hold on Investigational New Drug application for COVID-19-Influenza Combination and stand-alone influenza vaccine candidates- Achieved total revenue of
$85 million - Ended the third quarter of 2024 with
$1 billion - Received authorization from
U.S. FDA and European Commission for updated 2024-2025 formula COVID-19 vaccine in individuals aged 12 and older - Outlined R&D strategy based on its proven technology platform
- Updates full year 2024 financial guidance
- Company to host conference call today at 8:30 a.m. ET
"Novavax continues to focus on our corporate growth strategy of driving value from additional business development activities and organic R&D using our proven technology platform," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition to progress on our other value drivers, this past quarter, we made significant progress defining our R&D strategy as we look to expand beyond COVID-19 and influenza. We intend to develop our early-stage pipeline with a disciplined approach, as we focus on areas where our technology can have a positive impact on public health and generate value."
Third Quarter 2024 and Recent Highlights
During the third quarter, Novavax continued executing against its four key priorities.
Priority #1: Successful Execution of Sanofi Partnership
- Advanced preparation for Sanofi to assume lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine for 2025-2026 vaccination season in the
U.S. ,Europe and select major markets not currently subject to Novavax Advanced Purchase Agreements (APAs) or existing partnership agreements. - On track for the Novavax pediatric clinical trial database lock for the first cohort in the fourth quarter of 2024, achievement triggers a
$50 million
Priority #2: Drive Incremental Value from Novavax's Proven Technology Platform
- In November 2024, the
U.S. Food and Drug Administration (FDA) removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. Novavax is working to initiate the Phase 3 immunogenicity clinical trial for CIC and stand-alone influenza candidates as soon as possible. - Signed a Matrix-M adjuvant related agreement with a leading pharmaceutical company to enable exploration of our technology for the potential advancement of their pipeline candidates.
- Outlined guiding principles of new Research & Development (R&D) strategy based on its proven technology platform and announced the appointment of Ruxandra Draghia-Akli, MD, PhD as Executive Vice President and Head of R&D.
- Continued to advance pandemic influenza and respiratory syncytial virus (RSV) pre-clinical programs towards IND readiness, with a focus on RSV-combination options.
Priority #3: Continue Evolution of Novavax and Reduce Operating Expenses
- On track with cost structure improvements, including an approximate
26% reduction in combined R&D and Selling, General and Administrative (SG&A) expenses in the third quarter of 2024 compared to the same period for 2023. - Targeting full year combined R&D and SG&A expenses of approximately
$500 million $350 million $1.4 billion 80% as compared to full year 2022.
Priority #4: Deliver an Updated COVID-19 Vaccine for the 2024-2025 Vaccination Season
U.S. Market:
- Received Emergency Use Authorization (EUA) from the
U.S. FDA in individuals aged 12 and older. - Entered the market with an improved product presentation and broader access -Nuvaxovid™ available in pre-filled syringe presentation in over 30,000 locations across major pharmacy retailers and regional grocers in the
U.S. - Novavax's COVID-19 vaccine Biologics License Application (BLA) Prescription Drug User Fee Act with an action date of April 2025 and updated to include both JN.1 variant and pre-filled syringe presentation. Achievement of BLA approval triggers a
$175 million
Global Markets:
- Received global authorizations including in the European
Union, Canada , andTaiwan .
Third Quarter 2024 Financial Results
- Total revenue for the third quarter of 2024 was
$85 million $187 million $38 million $46 million - Cost of sales for the third quarter of 2024 was
$61 million $99 million $28 million $74 million - R&D expenses for the third quarter of 2024 were
$87 million $106 million - SG&A expenses for the third quarter of 2024 were
$71 million $107 million - Net loss for the third quarter 2024 was
$121 million $131 million - Cash, cash equivalents, marketable securities and restricted cash (Cash) were
$924 million $584 million
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 Aug. 8, 2024) | Updated (as of Nov. 12, 2024) |
Total Revenue | ||
Product Sales 1 | ||
Licensing, Royalties and Other Revenue 2 | ||
Combined R&D and SG&A |
1. | Full year 2024 product sales guidance reflects approximately |
2. | Full year 2024 Licensing, royalties and other revenue guidance includes |
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/3Y6irHG 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 November 12, 2024, until 11:59 p.m. ET on November 19, 2024. To access the replay by telephone, dial (888) 660-6345 (Domestic) or (+1) (646) 517-4150 (International) and use passcode 62491 #.
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 December 12, 2024.
Trade Name in the
The trade name Nuvaxovid has not been approved by the
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
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 corporate strategy and operating plans, objectives and prospects; its value drivers and near-term priorities, its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine; the development of Novavax's clinical and preclinical product candidates and innovation expansion opportunities; the conduct, timing and potential results from clinical trials and other preclinical studies; scope, timing and outcome of future and pending regulatory filings and actions, including the potential BLA approval for Novavax's COVID-19 vaccine; potential market sizes and demand for its COVID-19 vaccine and product candidates; full year 2024 financial guidance; and the amount and impact of Novavax's cost reduction plans; and Novavax's future financial or business performance. 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 ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024-2025 formula COVID-19 vaccine and the impact of its not having received a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; 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 or studies for its product candidates; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; 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 Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; 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; challenges in implementing its global restructuring and cost reduction plan; 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, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; 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 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; 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 | Nine Months Ended | |||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||||||||
Revenue: | ||||||||||||||||||||||||||
Product sales | $ 38,210 | $ 2,231 | $ 140,438 | $ 279,937 | ||||||||||||||||||||||
Licensing, royalties and other | 46,302 | 19,833 | 453,413 | 23,046 | ||||||||||||||||||||||
Grants | -- | 164,922 | -- | 389,380 | ||||||||||||||||||||||
Total revenue | 84,512 | 186,986 | 593,851 | 692,363 | ||||||||||||||||||||||
Expenses: | ||||||||||||||||||||||||||
Cost of sales | 60,619 | 98,929 | 166,070 | 188,792 | ||||||||||||||||||||||
Research and development | 87,164 | 106,229 | 286,789 | 572,805 | ||||||||||||||||||||||
Selling, general and administrative | 70,747 | 107,460 | 258,843 | 313,709 | ||||||||||||||||||||||
Total expenses | 218,530 | 312,618 | 711,702 | 1,075,306 | ||||||||||||||||||||||
Loss from operations | (134,018) | (125,632) | (117,851) | (382,943) | ||||||||||||||||||||||
Interest expense | (4,236) | (2,859) | (12,490) | (10,299) | ||||||||||||||||||||||
Other income (expense), net | 15,922 | (2,982) | 27,307 | 26,912 | ||||||||||||||||||||||
Loss before income tax expense (benefit) | (122,332) | (131,473) | (103,034) | (366,330) | ||||||||||||||||||||||
Income tax expense (benefit) | (1,032) | (697) | 3,435 | 343 | ||||||||||||||||||||||
Net Loss | $ (121,300) | $ (130,776) | $ (106,469) | $ (366,673) | ||||||||||||||||||||||
Net loss per share: | ||||||||||||||||||||||||||
Basic and diluted | $ (0.76) | $ (1.26) | $ (0.71) | $ (3.94) | ||||||||||||||||||||||
Weighted average number of common | ||||||||||||||||||||||||||
Basic and diluted | 160,049 | 103,429 | 149,486 | 93,046 | ||||||||||||||||||||||
SELECTED CONSOLIDATED BALANCE SHEET DATA | |||||
September 30, 2024 | December 31, 2023 | ||||
(unaudited) | |||||
Cash and cash equivalents | $ 573,630 | $ 568,505 | |||
Marketable securities | 335,901 | -- | |||
Total restricted cash | 14,957 | 15,305 | |||
Total current assets | 1,103,680 | 1,143,888 | |||
Working capital | (77,319) | (491,250) | |||
Total assets | 1,712,483 | 1,797,490 | |||
Convertible notes payable | 169,265 | 168,016 | |||
Total stockholders' deficit | (526,436) | (716,927) | |||
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.
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