Latest News by Industry
GAITHERSBURG, Md., May 9, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced its financial results and operational highlights for the first quarter ended March 31, 2023.
"Today we outlined significant measures intended to reduce spend, extend our cash runway, and operate more efficiently. Combined with our focus on revenue generation from Nuvaxovid™ and management of our current liabilities, these measures should strengthen our cash position and our potential for the long-term growth and stability of Novavax," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We also made significant progress on our other key priorities, including our efforts to deliver an updated COVID vaccine for the Fall season. And, today we announced positive Phase 2 data that we believe supports the further development of our combination COVID-influenza, standalone influenza, and high-dose COVID vaccines.
Reducing our workforce has been a difficult decision, but we believe it was necessary to better align our infrastructure and scale to the endemic COVID opportunity," continued Mr. Jacobs. "Though we still have substantial challenges ahead of us in 2023, we are encouraged by the progress we have made in the last quarter and are determined to continue executing on our top priorities."
First Quarter 2023 and Recent Highlights
During the quarter, the company has made progress delivering on the three near-term priorities laid out during its fourth quarter 2022 earnings call.
Priority #1: Deliver an Updated, Competitive COVID Vaccine for the Upcoming 2023 Fall Vaccination Season
Novavax remains focused on our top priority of delivering an updated, competitive COVID vaccine consistent with public health recommendations for the 2023 Fall vaccination season.
Priority #2: Reduce our Rate of Spend, Manage our Cash Flow and Evolve our Scale & Structure
Novavax is focused on significantly reducing our expenses while retaining the key capabilities needed to execute our operating plans.
Priority #3: Leverage our Technology Platform, our Capabilities and our Portfolio of Assets to Drive Additional Value Beyond Nuvaxovid Alone
Novavax continues to leverage our pipeline and technology with the intent of delivering long-term growth and protecting global health.
First Quarter 2023 Financial Results
Financial Framework and Guidance
Full Year 2023 Guidance
Revenue | Full Year 2023 Guidance |
Total Revenue1 | Between $1.4 billion and $1.6 billion |
Grant Revenue | Between $340 million and $360 million |
Product Sales2 | Between $1.06 billion and $1.24 billion |
1. | Total revenue includes Product Sales, Grants and Royalties/Other |
2. | APAs based on 2023 committed dose delivery schedules of approximately $800 million and U.S. market sales, subject to updated variant manufacturing and regulatory approvals |
3. | Novavax expects to record a restructuring charge of $10 million to $15 million related to employee severance and benefit costs, the majority of which are expected to be incurred in the second quarter of 2023, and is evaluating the anticipated cost related to the consolidation of facilities and infrastructure |
Full year 2023 R&D expense guidance excludes the potential costs associated with a Phase 3 Flu/CIC program. We plan to evaluate our positive Phase 2 Flu/CIC results announced today to frame our options to advance and finance this program via strategic collaborations and/or available financing alternatives.
2023 Liability Management
Conference Call
Novavax will host its quarterly conference call today at 8:30 a.m. ET. The dial-in numbers for the conference call are (877) 883-0383 (Domestic) or (412) 902-6506 (International). Participants will be prompted to request to join the Novavax, Inc. call. The passcode entry number is 3370620. A replay of the conference call will be available starting at 11:30 a.m. ET on May 9, 2023 until 11:59 p.m. ET on May 16, 2023. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1969560.
A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until August 7, 2023.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to 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. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID, influenza, and COVID and influenza combined. Please visit novavax.com and LinkedIn for more information.
Use of Non-GAAP Measures
The Company has used a non-GAAP financial measure in this press release, which is R&D and SG&A expense, as adjusted to exclude one-time restructuring costs including a restructuring charge of $10 million to $15 million related to employee severance and benefit costs. 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 excluding 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. The company is unable to reconcile this forward-looking non-GAAP financial measure to the most directly comparable GAAP measure without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of the anticipated costs related to the consolidation of facilities and infrastructure that would be expected to impact GAAP measure for the period but would not impact the non-GAAP measure.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its near term priorities including delivering an updated, competitive COVID vaccine for the 2023 Fall vaccination season, reducing spend, extending its cash runway and operating efficiently, the amount and impact of Novavax's global restructuring and cost reduction plan, its operating plans, objectives and prospects full year 2023 financial guidance, its future financial or business performance, conditions or strategies, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including Part 2 of the Phase 3 strain change study, the CIC investigational vaccine candidate, the scope, timing and outcome of future and pending regulatory filings and actions, including expected U.S. Biologics License Application filing in second half of 2023, future deliveries under APAs and Novavax's ability to advance and finance a Phase 3 Flu/CIC program via strategic collaborations and / or financing alternatives 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, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the Fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; challenges in implementing our global restructuring and cost reduction plan; challenges in obtaining commercial adoption of NVX-CoV2373 or a COVID variant strain-containing formulation; 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, 2022, 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 March 31, | ||||
2023 | 2022 | |||
(unaudited) | ||||
Revenue: | ||||
Product sales | $ (7,457) | $ 585,628 | ||
Grants | 87,379 | 99,301 | ||
Royalties and other | 1,029 | 19,042 | ||
Total revenue | 80,951 | 703,971 | ||
Expenses: | ||||
Cost of sales | 34,086 | 15,204 | ||
Research and development | 247,101 | 383,483 | ||
Selling, general and administrative | 112,532 | 95,992 | ||
Total expenses | 393,719 | 494,679 | ||
Income (loss) from operations | (312,768) | 209,292 | ||
Interest expense | (4,316) | (4,876) | ||
Other income (expense) | 24,362 | 1,654 | ||
Income (loss) before income tax expense | (292,722) | 206,070 | ||
Income tax expense (benefit) | 1,183 | 2,662 | ||
Net income (loss) | $ (293,905) | $ 203,408 | ||
Net income (loss) per share | ||||
Basic | $ (3.41) | $ 2.66 | ||
Diluted | $ (3.41) | $ 2.56 | ||
Weighted average number of common shares outstanding Basic | 86,158 | 76,457 | ||
Diluted | 86,158 | 80,711 |
SELECTED CONSOLIDATED BALANCE SHEET DATA | ||||
March 31, 2023 | December 31, 2022 | |||
(unaudited) | ||||
Cash and cash equivalents | $ 624,950 | $ 1,336,883 | ||
Total restricted cash | 11,993 | 11,962 | ||
Total current assets | 971,028 | 1,703,391 | ||
Working capital | (947,830) | (756,553) | ||
Total assets | 1,542,699 | 2,258,679 | ||
Convertible notes payable* | 166,857 | 491,347 | ||
Total stockholders' equity (deficit) | (895,582) | (634,078) | ||
* | Included in noncurrent liabilities as of March 31, 2023 and current and non-current liabilities as of December 31, 2022. |
Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan | 240-720-7804
media@novavax.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/novavax-reports-first-quarter-2023-financial-results-and-operational-highlights-301819064.html
SOURCE Novavax, Inc.