Novavax Conference Call Summary Company Overview - Novavax is recognized for its successful development of a highly efficacious COVID-19 vaccine using subunit protein nanoparticle technology combined with the Matrix-M adjuvant, which has also been utilized in a malaria vaccine developed by Serum Institute of India [4][5] Strategic Focus - The company is transitioning from a pandemic-focused entity to an endemic-based vaccine manufacturer, partnering with Sanofi to integrate its COVID-19 vaccine, Nuvaxovid, into Sanofi's portfolio of vaccines [5][6] - Novavax aims to reduce costs, strengthen its balance sheet, and advance its pipeline through partnerships, with a long-term goal of achieving profitability and diversified revenue streams [6][9] Partnership with Sanofi - The partnership with Sanofi is structured in layers, including commercialization of the COVID-19 vaccine, development of combination vaccines, and leveraging Matrix-M in Sanofi's portfolio [9][10] - The market for combination flu and COVID-19 vaccines could reach $8 billion annually, with Novavax eligible for up to $350 million in milestones and royalties ranging from high single digits to low teens [10][11] - Sanofi's 2026 season is expected to be the full launch year for the COVID-19 vaccine, with 2025 serving as a transition year for learning and marketing efforts [12][13] Financial Highlights - Novavax received a $70 million investment from Sanofi, $500 million upfront, and has the potential for $700 million in milestone payments [22][23] - In the current year, Novavax earned $225 million in milestones, with royalties expected to grow significantly as the partnership matures [23] Matrix-M Adjuvant - Matrix-M is positioned as a critical driver of innovation in the vaccine industry, with potential royalties of mid-single digits for up to 20 years on new vaccines developed using this adjuvant [25][26] - The global vaccine market is projected to grow from $57 billion in 2024 to over $75 billion by 2030, highlighting the significant opportunity for Matrix-M [25] Early Stage Pipeline - Novavax is exploring various early-stage vaccines targeting infectious diseases, including CDIF, shingles, RSV, and pandemic flu, with a focus on addressing unmet medical needs [38][39] - The company is also investigating the use of Matrix-M in oncology vaccines, collaborating with partners to explore its potential in this area [34][41] Market Potential - The oncology vaccine market is valued at over $40 billion, contributing to a combined market potential exceeding $100 billion when combined with the vaccine market [34] - Novavax's approach includes leveraging AI and machine learning to enhance immune responses and develop tailored vaccines for specific needs [33][41] Conclusion - Novavax is strategically positioned to capitalize on its innovative technologies and partnerships, with a clear focus on expanding its vaccine portfolio and driving long-term value creation through diversified revenue streams and cost management [6][23][25]

Core Insights - Novavax reported a narrower loss of 62 cents per share in Q3 2025, compared to the Zacks Consensus Estimate of a loss of $1.08 per share and a loss of 79 cents per share in the same quarter last year [1][7] - Quarterly revenues reached $70 million, down 18% year-over-year, but exceeded the Zacks Consensus Estimate of $40 million [2][7] - The company raised its 2025 revenue guidance to between $1.04 billion and $1.06 billion, up from the previous estimate of $1.00 billion to $1.05 billion [10] Financial Performance - Novavax's product sales were $13 million, a significant decrease from $41.5 million in the prior year, with no revenue generated from its COVID vaccine Nuvaxovid during the quarter [3] - Licensing, royalties, and other revenues totaled $57 million, including a $48 million milestone payment from Sanofi, marking a 33% increase year-over-year [4] - Research and development (R&D) expenses were $98 million, up 12.6% year-over-year, while selling, general, and administrative (SG&A) expenses decreased by 55% to $32 million [8] Cash Position - As of September 30, 2025, Novavax had $778 million in cash and cash equivalents, an increase from $628 million as of June 30, 2025 [9] Strategic Developments - Novavax completed the transition of the COVID vaccine's commercial leadership to Sanofi for the 2025-2026 vaccination season [4] - The company amended its collaboration and license agreement with Sanofi to expand the use of its Matrix-M adjuvant in pandemic influenza vaccine candidates [11][12] - Novavax received an additional $50 million in milestone payments due to the transfer of marketing authorization for Nuvaxovid to Sanofi in the U.S. and EU [13][14] Market Performance - Shares of Novavax have declined by 5.6% year-to-date, contrasting with an 11.4% rise in the industry [5]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $70 million, a decrease from $85 million in Q3 2024 [23][25] - The company recorded a net loss of $202 million, or $1.25 per diluted share, for the third quarter of 2025 [27] - Cash and accounts receivable at the end of Q3 2025 stood at $812 million, prior to factoring in additional earnings from recent transactions [25] Business Line Data and Key Metrics Changes - Product sales for Q3 2025 amounted to $13 million, primarily from COVID-19 vaccine and Matrix-M supply sales [25] - Licensing royalties and other revenue reached $57 million, mainly from the Sanofi agreement, including $46 million in R&D reimbursement [26] Market Data and Key Metrics Changes - Sanofi recorded $23 million in Nuvaxovid sales in Q3 2025, with Novavax earning $4 million in royalties from these sales [23][25] - The company anticipates a significant increase in royalties from Sanofi in 2026 as they prepare for a full commercial launch [32] Company Strategy and Development Direction - The company is transitioning from a focus on COVID-19 vaccine sales to a diversified pipeline and partnerships, aiming for long-term growth and profitability [5][7] - Key priorities for 2025 include optimizing the partnership with Sanofi, enhancing existing partnerships, and advancing the technology platform and early-stage pipeline [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving non-GAAP profitability as early as 2028, contingent on successful partnerships and product developments [10][54] - The company is focused on reducing costs and improving financial strength while navigating a transition year with Sanofi [24][54] Other Important Information - The company has secured $1.4 billion in new cash while reducing its cost structure and liabilities, with 78% of this cash coming from non-dilutive sources [30] - A significant milestone of $225 million from Sanofi has been achieved, consistent with the 2025 revenue framework [25][30] Q&A Session Summary Question: How does the company see the 2025 COVID season compared to last year? - Management noted a 20% decrease in prescriptions compared to last year, attributing this to a more restrictive policy in the U.S. [41] Question: Can you provide more details on the BARDA grant? - The BARDA grant awarded to Sanofi is for early-stage work on a pandemic influenza vaccine that includes Novavax's Matrix-M adjuvant [43] Question: What are the next steps for the Sanofi collaboration? - Management is excited about the positive data from Sanofi's combination programs and is awaiting further updates on regulatory engagement [46] Question: What is the clinical bar for success for the shingles vaccine? - The company is confident in its data and is conducting experiments with positive controls to ensure comparability with existing vaccines [74][75]

Financial Performance & Strategy - Total revenue for Q3 2025 was $70 million, a decrease of 18% compared to $85 million in Q3 2024[25] - The company achieved $1.1 billion in non-dilutive funding over the past 8 quarters[14] - Novavax is aiming for Non-GAAP profitability as early as 2028, driven by diversified revenue streams[15] - Combined R&D and SG&A expenses for Q3 2025 decreased by 18% compared to Q3 2024[22] - The company anticipates combined R&D and SG&A expenses less partner reimbursement of approximately $350 million for FY 2026 and $250 million for FY 2027[35] Sanofi Partnership - Sanofi revenue in Q3 2025 was $48 million, including $4 million in COVID-19 royalties[23, 28] - Novavax expects $60 million in cash from Sanofi by Q1 2026 related to the COVID-19 commercial role transition[23] - The Sanofi partnership is projected to result in $230 million in operating cost savings over 11 years[23] 2025 Financial Outlook - Adjusted Total Revenue for full year 2025 is projected to be between $1040 million and $1060 million[39] - Nuvaxovid product sales are expected to be $610 million for full year 2025, including $603 million from the termination of the Canada and New Zealand Advance Purchase Agreements[39] Pipeline Development - The company is advancing an early-stage pipeline focused on diseases with high unmet medical needs, including Varicella Zoster Virus (Shingles), C difficile, RSV combinations, and Pandemic Flu[14, 19]

Core Insights - Novavax reported a total revenue of $70 million for Q3 2025, a decrease of 18% compared to $85 million in Q3 2024, primarily due to a significant drop in Nuvaxovid sales [3][7][23] - The company is focusing on optimizing partnerships, particularly with Sanofi, and enhancing its technology platform to drive long-term growth and profitability [2][5][20] Financial Performance - Nuvaxovid sales were $0 in Q3 2025, down from $38 million in Q3 2024, while supply sales increased to $14 million from $3 million [3][7] - Product sales decreased by 68% to $13 million from $41 million year-over-year [3][7] - Sanofi partnership revenue increased by 33% to $48 million from $36 million [3][7] - Total expenses for Q3 2025 were $248 million, compared to $219 million in Q3 2024, with R&D expenses rising to $98 million from $87 million [7][23] Strategic Initiatives - The company achieved $225 million in milestones from its partnership with Sanofi year-to-date, including $50 million from marketing authorization transfers [5][6] - Sanofi reported positive Phase 1/2 data for Nuvaxovid in combination with its influenza vaccines, which received Fast Track designation from the FDA [6][20] - Novavax is pursuing government funding for a pandemic influenza vaccine candidate and exploring its Matrix-M platform technology in oncology [6][20] Future Guidance - Novavax raised its full-year 2025 revenue framework, expecting adjusted total revenue between $1,040 million and $1,060 million [9][10] - The company anticipates combined R&D and SG&A expenses of $505 million to $535 million for the full year 2025 [8][10] - The transition of lead commercial responsibility for Nuvaxovid to Sanofi is expected to impact revenue forecasts, which are not included in the full-year guidance [9][15]

Core Viewpoint - Novavax, Inc. is recognized as a promising long-term biotechnology investment, with Cantor Fitzgerald initiating coverage with an Overweight rating and a price target of $18 [1] Group 1: Company Strategy and Developments - Novavax is transitioning from direct commercialization to a licensing model, focusing on revenue generation through partnerships related to its Matrix-M adjuvant and vaccine portfolio [2] - The company has transferred its COVID-19 vaccine, Nuvaxoid, to Sanofi, granting Sanofi full responsibility for commercial and regulatory activities in the EU, and is set to receive a $25 million milestone payment [2][3] - Novavax is entitled to additional future milestone payments, including a $75 million payment upon Sanofi's technology transfer of its manufacturing process, and could receive up to an additional $350 million in future milestone payments [3] Group 2: Product and Technology - Novavax develops innovative vaccines using protein-based technology, specifically recombinant nanoparticle technology and its proprietary Matrix-M adjuvant to enhance immune response [3]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of EUR 12.4 billion, representing a 7% increase compared to the previous year [4] - Business EPS reached EUR 2.91, reflecting a robust growth of EUR 0.19 or 13% compared to Q3 2024 [15] - The gross margin increased by 2.3 percentage points this quarter, driven by an improved product mix and productivity gains [13] Business Line Data and Key Metrics Changes - Pharmaceutical sales grew by 7% at constant exchange rates, primarily driven by immunology and recent launches [13] - New product launches contributed EUR 1.8 billion in sales this quarter, accounting for 15% of total sales [6] - Dupixent sales reached EUR 4 billion for the first time, with a 26% growth this quarter [7][15] Market Data and Key Metrics Changes - Vaccine sales were EUR 3.4 billion, reflecting a decrease due to competitive price pressure and lower flu immunization rates in the U.S. [8] - Outside the U.S., Dupixent sales grew by 21%, exceeding EUR 1 billion in the quarter [8] - Beyfortus sales increased by 20% this quarter, now available in 40 countries [9] Company Strategy and Development Direction - The company aims to improve access to treatments and lower prices for patients, as demonstrated by the expansion of its patient affordability program for insulins [5][11] - The focus remains on innovation in respiratory vaccines and expanding the commercial portfolio with new product launches [10][11] - The company is committed to maintaining a balanced capital allocation policy, focusing on organic growth, selective acquisitions, and progressive dividends [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year and reiterated full-year sales guidance [4] - The company anticipates continued growth momentum, with expectations for high single-digit sales growth and low double-digit business EPS growth at constant exchange rates for the full year [15][16] - Management acknowledged challenges in the vaccine segment but remains committed to innovation and improving patient access [10][11] Other Important Information - The company has achieved a milestone of treating 1 million patients for non-communicable diseases across low and middle-income countries since 2021 [11] - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint, with associated costs factored into guidance [15] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing conversations with the FDA and submitted data sets, looking forward to the PDUFA date of December 28 [32] Question: Update on U.S. policy conversations - Management stated that dialogues with the U.S. government have been ongoing and focused on demonstrating the value the company can bring [38] Question: Q4 ordering trends for Beyfortus - Management confirmed expectations for Q4 performance to be similar to Q3, with a focus on increasing vaccination coverage rates in the U.S. [42][44] Question: Insights on Dupixent's COPD development and gross to net dynamics - Management highlighted strong growth in COPD and indicated that gross to net dynamics are monitored and included in long-term guidance [81] Question: Timing dynamics around riliprubart and other programs under review - Management indicated that timelines for riliprubart are being updated and that data from various studies will be presented at relevant scientific congresses [62] Question: Potential for product acquisitions and vaccine trends - Management acknowledged the success of Dupixent and indicated a cautious approach to M&A, while also addressing concerns about vaccine fatigue [90]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of €12.4 billion, representing a 7% increase compared to the previous year [4] - The business gross margin increased by 2.3 percentage points, driven by an improved product mix and productivity gains [13] - Business EPS reached €2.91, reflecting a robust growth of €0.19 or 13% compared to Q3 2024 [15] Business Line Data and Key Metrics Changes - Pharmaceutical sales grew by 7% at constant exchange rates, primarily driven by immunology and recent launches [13] - New launches contributed €1.8 billion in sales, accounting for 15% of total sales, with Dupixent sales growing by 26% this quarter [6][13] - Vaccine sales were €3.4 billion, down from the previous year due to competitive price pressure and lower flu immunization rates [8] Market Data and Key Metrics Changes - Sales outside the U.S. grew by 21%, exceeding €1 billion in the quarter [8] - Dupixent sales in the U.S. surpassed €3 billion, maintaining leadership in both new and total prescriptions across established indications [7] Company Strategy and Development Direction - The company aims to improve access to treatments and lower prices for patients, as demonstrated by the expansion of its patient affordability program for insulins [5][11] - The company is focused on advancing its innovative pipeline, with multiple regulatory submissions and approvals expected in the coming years [18][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year and reiterated full-year 2025 sales guidance [4] - The company anticipates maintaining strong earnings momentum with 9% sales growth and low double-digit business EPS growth at constant exchange rates [15][16] Other Important Information - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint Medicines, which are factored into the guidance [15] - The company is committed to capital allocation across organic growth, selective acquisitions, dividends, and opportunistic share buybacks [17] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing conversations with the FDA and looks forward to the PDUFA date of December 28 [31] Question: Update on U.S. policy conversations - Management stated that dialogues with the U.S. government have been ongoing and focused on demonstrating the value the company can bring [38] Question: Q4 ordering trends for Bayfortis - Management confirmed expectations for Q4 to be in line with Q3 performance and emphasized efforts to increase vaccination coverage rates [42][45] Question: 2027 guidance and potential levers to mitigate EBIT gap - Management acknowledged a significant R&D reimbursement decrease in 2027 but expressed confidence in maintaining profitability despite the gap [50][52] Question: Update on relipiravir and timing dynamics - Management indicated that patient recruitment is affecting timelines for CIDP studies, with results expected in the future [62] Question: Dupixent development around COPD and gross to net dynamics - Management highlighted strong growth in COPD and discussed the impact of payer groups on gross to net dynamics [81]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of €12.4 billion, representing a 7% increase compared to the previous year [3] - Business EPS reached €2.91, reflecting a robust growth of €0.19 or 13% compared to Q3 2024 [13] - The gross margin increased by 2.3 percentage points this quarter, driven by an improved product mix and productivity gains [11] Business Line Data and Key Metrics Changes - Sales growth was primarily driven by the pharmaceutical segment, particularly immunology and recent launches, with new launches contributing €1.8 billion, representing 15% of total sales [4][11] - Dupixent sales reached €4 billion in quarterly sales for the first time, with a 26% growth this quarter [5][11] - Vaccine sales were €3.4 billion, reflecting competitive price pressure and lower flu immunization rates in the U.S. [6] Market Data and Key Metrics Changes - Outside the U.S., sales grew by 21%, exceeding €1 billion in the quarter [6] - The U.S. market remains the largest, with Dupixent surpassing €3 billion in quarterly sales [5] Company Strategy and Development Direction - The company is focused on expanding access to treatments and improving patient affordability, as demonstrated by the expansion of its patient affordability program for insulins [4][10] - The company aims to maintain its profitable growth momentum and has reiterated its full-year guidance of high single-digit sales growth and low double-digit business EPS growth at constant exchange rates [13][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year, citing strong performance from new launches and Dupixent [3] - The company is committed to innovation in respiratory viruses and improving patient access to healthcare, with a goal of treating 2 million patients for non-communicable diseases by 2030 [10] Other Important Information - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint Medicines, which are factored into its guidance [13][15] - The company is advancing its flu pandemic preparedness with two programs and is working on flu-COVID combination vaccines [9] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing dialogue with the FDA and submitted data sets, looking forward to the PDUFA date of December 28 [30][31] Question: Updates on U.S. policy conversations - Management stated that they have had ongoing dialogue with the U.S. government and are focused on demonstrating the value they can bring [36][37] Question: Q4 ordering trends for Bayfortis and competition impact - Management confirmed expectations for Q4 to be similar to Q3 for Bayfortis, with a focus on increasing vaccination coverage rates in the U.S. [39][41] Question: 2027 guidance and potential levers to mitigate EBIT gap - Management acknowledged a significant R&D reimbursement decrease in 2027 but indicated that they expect to grow at a reasonable pace despite the gap [45][49] Question: Update on relipiravir and timing dynamics - Management indicated that the outcome for the phase three studies for CIDP is delayed due to patient recruitment but remains optimistic about the results [59][60] Question: Dupixent gross margin improvement and COPD launch - Management noted that Dupixent's gross margin improvement was limited in Q3, with overall gross margin increasing by 2.5% [66][85]

Core Viewpoint - Shah Capital is urging Novavax Inc. to consider a sale due to ongoing challenges in the rollout of its COVID-19 vaccine, suggesting that its assets could be more valuable in the hands of a larger pharmaceutical company [1][2]. Company Performance - Novavax's stock is showing strong performance, with a current price of $8.89, reflecting a 3.07% increase [7]. - The company has a market capitalization of approximately $1.4 billion, while Shah Capital estimates its value could be "at least $5 billion" based on the potential of its vaccines [3]. Market Position - Novavax's COVID-19 vaccine, Nuvaxovid, has only captured 2% of the market, significantly underperforming compared to competitors like Pfizer and Moderna, which distributed nearly six million doses each [5][6]. - In the second quarter of 2025, Novavax reported sales of $239.24 million, a decrease from $415 million a year ago, but exceeding the consensus estimate of $156.29 million [6]. Strategic Insights - Shah Capital holds a 7.2% stake in Novavax, making it the second-largest shareholder, and has identified potential buyers among major pharmaceutical companies such as Sanofi, Merck, GSK, and AstraZeneca [2]. - The hedge fund noted that favorable political conditions and scientific data could benefit Novavax moving forward [4].