Financial Data and Key Metrics Changes - Novavax recorded total revenue of $85 million for Q3 2024, down from $187 million in Q3 2023, with product sales increasing to $38 million from $2 million in the same period last year [66][70] - Combined R&D and SG&A expenses were reduced by 26% to $158 million compared to Q3 2023, with a full-year guidance for R&D and SG&A expenses set between $700 million and $750 million, reflecting a decrease of approximately 40% compared to 2023 [67][68] - The company ended Q3 2024 with over $1 billion in cash and accounts receivables, maintaining a strong cash position [69] Business Line Data and Key Metrics Changes - The COVID-19 vaccine program saw significant improvements, with Novavax's vaccine administrations in the US outperforming the entire previous season, achieving a current market share of approximately 3% [31][32] - The company initiated the '24-'25 COVID-19 commercial season earlier than last year, with expectations of a total market size of approximately 40 million to 50 million shots this season [33] - The standalone influenza vaccine program is positioned to potentially be the first recombinant-based protein adjuvanted flu vaccine in the market, with plans to partner these assets [19][20] Market Data and Key Metrics Changes - Novavax's vaccine is now available in over 30,000 locations, including major pharmacies, which has increased visibility and access [34] - The company achieved approximately 70% market share in certain regions with favorable market access contracts, particularly among the target audience of individuals aged 65 and older [36] Company Strategy and Development Direction - The company is focused on a new corporate growth strategy that emphasizes business development and organic R&D, transitioning from a singular focus on the COVID-19 vaccine to a broader portfolio [9][10] - Key value drivers include the Sanofi partnership, late-stage pipeline development, leveraging technology for additional partnerships, and expanding the early-stage pipeline [11][12] - The company aims to execute a disciplined expense management strategy to support its growth initiatives [12][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for COVID-19 vaccines and the potential for Sanofi's commercialization efforts to enhance market share in 2025 and beyond [39][40] - The company is preparing for a seamless transition of commercial activities to Sanofi, which is expected to leverage Sanofi's scale and resources [39][40] - Management highlighted the importance of maintaining a flexible cost structure while pursuing value creation through strategic partnerships and R&D [26][69] Other Important Information - The clinical hold on the CIC and standalone influenza vaccine candidates has been lifted, allowing the company to proceed with Phase 3 trials [45][46] - The company welcomed Dr. Ruxandra Draghia as the new Head of R&D, expected to play a crucial role in evaluating future pipeline opportunities [30] Q&A Session Summary Question: Clinical hold removal and Phase 3 trial timing - Management confirmed that they are working on logistics to start the Phase 3 trial as soon as possible, with no specific date provided yet [90][92] Question: Commercial sales and market dynamics - The company reported $38 million in commercial sales, primarily from the US, and discussed the dynamics of retail versus non-retail channels [95][111] Question: Future IND filings and Sanofi's prioritization - The next IND filings are expected to be for the RSV combination program and pandemic influenza, with Sanofi preparing to initiate a Phase 1/2 CIC study this year [104][105]

Group 1 - Novavax shares declined after the company reduced its full-year revenue guidance in its third-quarter results [1][3] - The revised full-year revenue expectation is $650 million to $700 million, down from a previous estimate of $700 million to $800 million, and below the analyst consensus of $747.6 million [2] - In the third quarter, revenue decreased by 55% year-over-year to $85 million, compared to $187 million a year earlier, although it exceeded analysts' expectations [3] Group 2 - The FDA has allowed Novavax to continue testing its combination COVID-19-flu and standalone flu vaccines after lifting a clinical hold on the studies [4] - The FDA's decision enables Novavax to begin enrolling participants for a planned Phase 3 trial, indicating that the company has satisfactorily addressed all clinical hold issues [4]

| --- | --- | --- | |-------------------------------------|---------------------|-------| | | Third quarter 2024 | | | | | | | operational | financial results & | | | highlights | | | | Nasdaq: NVAX \| November 12th, 2024 | | | © 2024 NOVAVAX. All rights reserved. 1 Cautionary note regarding forward-looking statements This presentation includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," ...

Novavax (NVAX) came out with a quarterly loss of $0.76 per share versus the Zacks Consensus Estimate of a loss of $0.87. This compares to loss of $1.26 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 12.64%. A quarter ago, it was expected that this vaccine maker would post earnings of $1.82 per share when it actually produced earnings of $0.99, delivering a surprise of -45.60%.Over the last four quarters, the company has surpa ...

Core Viewpoint - Novavax, Inc. has made significant progress in its R&D strategy and financial performance, including the removal of the clinical hold on its COVID-19-Influenza Combination vaccine and the authorization for its updated COVID-19 vaccine for the 2024-2025 season [1][5][7]. Financial Performance - Total revenue for Q3 2024 was $85 million, a decrease from $187 million in Q3 2023 [9]. - Product sales amounted to $38 million, primarily from the U.S. market, while licensing, royalties, and other revenue were $46 million [9]. - The net loss for Q3 2024 was $121 million, compared to a net loss of $131 million in the same period in 2023 [9][18]. Operational Highlights - The company ended Q3 2024 with $1 billion in cash and receivables [1]. - Novavax is advancing its partnership with Sanofi for the Nuvaxovid™ COVID-19 vaccine, with a milestone payment of $50 million expected upon completion of pediatric clinical trial database lock [4]. - The FDA has removed the clinical hold on Novavax's Investigational New Drug application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates [5]. R&D Strategy - Novavax is focusing on expanding its early-stage pipeline beyond COVID-19 and influenza, utilizing its proven technology platform [2]. - The company has outlined guiding principles for its new R&D strategy and appointed Ruxandra Draghia-Akli as Executive Vice President and Head of R&D [5]. - Ongoing pre-clinical programs for pandemic influenza and respiratory syncytial virus (RSV) are being advanced towards IND readiness [5]. Cost Management - Novavax achieved a 26% reduction in combined R&D and SG&A expenses in Q3 2024 compared to the same period in 2023 [6]. - The company targets combined R&D and SG&A expenses of approximately $500 million for 2025 and $350 million for 2026, reflecting a significant reduction from previous years [6]. Market Position - The updated COVID-19 vaccine has received Emergency Use Authorization from the U.S. FDA for individuals aged 12 and older, with broader access through over 30,000 locations in the U.S. [7][9]. - Global authorizations have been received, including in the European Union, Canada, and Taiwan [9].

Core Insights - Novavax has received approval from the FDA to resume testing its combination COVID-19-flu and standalone flu vaccines, which had previously been put on hold due to a serious adverse event reported in a patient [1] - The FDA's clinical hold was lifted after Novavax provided sufficient information addressing the concerns raised, allowing the company to begin enrolling participants for the planned Phase 3 trial [1] - Following the announcement, Novavax's shares increased by 1%, and the stock has risen nearly 90% year-to-date [1] Company Summary - The FDA had previously halted Novavax's vaccine trials after a report of a serious adverse event (motor neuropathy) in a Phase 2 trial participant [1] - Novavax's Chief Medical Officer stated that the data provided to the FDA indicated that the adverse event was unrelated to the vaccine, supporting the company's position [1] - The company is now preparing to initiate its Phase 3 trial as soon as possible [1]

Novavax (NVAX) is scheduled to report third-quarter 2024 earnings on Nov. 12, before the opening bell. In the last reported quarter, the company’s earnings missed estimates by 45.60%.The Zacks Consensus Estimate for sales is pegged at $57.3 million while that for earnings is pinned at a loss of 87 cents per share.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Factors Shaping NVAX’s Upcoming ResultsAlthough Novavax secured the FDA’s authorization for an updated version of its protei ...

Core Points - Novavax, Inc. has received clearance from the U.S. FDA to proceed with its Phase 3 trial for the COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates after addressing all clinical hold issues [1][2] - The clinical hold was initially imposed due to a serious adverse event reported during a Phase 2 trial, which was later determined to be unrelated to the vaccine [2] Company Overview - Novavax, Inc. is focused on developing innovative vaccines to combat serious infectious diseases, utilizing a recombinant protein approach and its patented Matrix-M adjuvant to enhance immune response [3] - The company's portfolio includes a COVID-19 vaccine and candidates for the CIC and stand-alone influenza vaccines, with its adjuvant also being used in other vaccine collaborations [3]

The market expects Novavax (NVAX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on November 12, 2024, might help the stock move higher if these key numbers are ...

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024. Details of the event and replay are as follows: Conference call details: Date: November 12, 2024 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/3Y6irHG Dia ...