Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

This stock could be a wealth destroyer in the next five years.Novavax (NVAX +0.63%) was once a leading contender to dominate the coronavirus vaccine market. The company faced several challenges, however, and although it successfully launched its vaccine, Nuvaxovid, revenue and earnings have remained inconsistent for years, and the stock has delivered subpar returns. Unfortunately for Novavax, it is unlikely to perform significantly better over the medium term.Here's why it'd be best for investors to avoid t ...

Core Insights - Novavax, Inc. (NASDAQ:NVAX) is transitioning from a direct COVID-19 commercial operation to a research and development-focused company, particularly through its partnership with Sanofi [1] Financial Performance - For Q3 2025, Novavax reported total revenue of $70 million, an 18% decrease from $85 million in the same quarter last year [2] - Licensing, royalties, and other revenue increased from $43 million to $57 million, while product sales dropped significantly from $41 million to $13 million year-over-year [2] Future Projections - The company raised its full-year 2025 adjusted revenue projection to $1,040–$1,060 million, with expectations of $610 million in Nuvaxovid product sales and $35–45 million in adjusted supply sales [3] - Analyst Mayank Mamtani from B. Riley Securities reiterated a Buy rating for Novavax but lowered the price target from $18 to $16 [3] Company Overview - Novavax is a biotechnology firm focused on developing and commercializing innovative vaccines to prevent serious infectious diseases, utilizing recombinant nanoparticle technology and its proprietary Matrix-M adjuvant to enhance immune response [4]

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]