Novavax’s 2025 Q4 Call: Partnership Shifts, Profitability Delays, and Regulatory Roadblocks Clash

Date of Call: Feb 26, 2026

Financials Results

• Revenue: Full year 2025 total revenue of $1.1 billion, a 65% increase year-over-year. Q4 2025 revenue of $147 million, a 67% increase year-over-year.
• Operating Margin: Positive operating income for both full year and Q4 2025.

Guidance:

• Non-GAAP combined R&D and SG&A expense guidance improved for 2026 and 2027: $325M and $225M at midpoint, respectively, with a 2028 target of $200M or below.
• 2026 adjusted total revenue expected between $230M and $270M, including $35M-$45M Nuvaxovid product sales, $40M-$50M adjusted supply sales, $155M-$175M adjusted licensing/royalties, and $35M noncash amortization.
• Expects Sanofi royalties to grow significantly in 2026 as they leverage tools to compete in U.S. and global markets.
• Cash runway estimated into 2028 without new cash flow.

Business Commentary:

Revenue Growth and Strategic Partnerships:

• Novavax reported total revenue of $1.1 billion for the full year 2025, a 65% increase year-over-year.
• The growth was driven by additional Nuvaxovid product sales, Matrix-M adjuvant supply sales, and licensing and royalty revenues, supported by strategic partnerships with companies like Pfizer and Sanofi.

Cost Reduction and Financial Stability:

• The company achieved a 53% decrease in combined R&D and SG&A expenses on a non-GAAP basis for the fourth quarter of 2025.
• This reduction was part of a strategy to streamline operations and stabilize the company financially, enabling a projected cash runway into 2028.

Partnership Expansion and Technology Licensing:

• Novavax signed a new agreement with Pfizer for Matrix-M, potentially generating billions in revenue through milestones and royalties.
• This partnership, along with others, highlights the broad interest in Novavax's adjuvant technology, driven by its proven efficacy and versatility across different vaccine platforms.

R&D Focus and Pipeline Advancement:

• Novavax is focused on leveraging its Matrix technology to develop new vaccine candidates, with plans to advance at least one preclinical asset into the clinic as early as 2027.
• The company's R&D efforts are directed towards addressing significant unmet medical needs, such as in C. difficile and shingles, with a strategy to create differentiated assets for potential partnerships.

Sentiment Analysis:

Overall Tone: Positive

• Executives expressed excitement about progress and future potential, citing 'significant progress on our corporate strategy,' 'started the year off strong with the new Pfizer partnership,' and being 'on a path to deliver long-term sustainable value.' They highlighted strong operational execution, a pipeline of potential partners, and optimism about regulatory pathways, stating 'we remain optimistic about the future of vaccines and of Novavax.'

Q&A:

• Question from Jiale Song (Jefferies): Based on your interaction with Sanofi's new CEO or management, any updated views on their vaccine business strategy? And comments on 2026 COVID sales expectations?
  Response: Relationship with Sanofi remains positive and unchanged; partnership is bright. Upcoming 2026 COVID season looks very promising as it's Sanofi's first full year leveraging all commercial tools, including direct-to-consumer advertising.

• Question from Jiale Song (Jefferies): Regarding the early pipeline (C. diff, shingles, RSV), any prioritization or timing for first IND as early as 2027?
  Response: All three early programs are advancing; goal is to advance at least one into clinic as early as 2027. C. diff was highlighted as an example due to significant unmet need.

• Question from Thomas Shrader (BTIG): Are co-promotes attractive for Matrix-M partnerships? And what are next steps for new Matrix-based adjuvants tailored for T cell responses?
  Response: Core focus is on partnering and data generation, not co-promotion currently. New Matrix-based adjuvants are being developed in-house for specific immune responses and will be offered to partners in fields like oncology.

• Question from Unknown Analyst (JPMorgan): Can you provide more color on the MTA expanded to explore an additional field, and the potential timeline for MTAs turning into formal partnerships?
  Response: Interest is high as companies experiment with Matrix-M and often return to expand into other fields. Timeline for formal partnerships is TBD and depends on partner development; Novavax is building a pipeline of potential partners at various stages.

• Question from Mayank Mamtani (B. Riley Securities): How do you assess the value of your own clinical-stage CIC and flu programs compared to Sanofi's partnered programs, given regulatory feedback?
  Response: Encouraged by Sanofi's public comments on combination programs as key drivers for future growth and their regulatory review expected in 2027-2028 timeframe. Sees a pathway forward for vaccines.

• Question from Mayank Mamtani (B. Riley Securities): Clarify the target annualized run rate for 2026 and provide more color on Sanofi's new manufacturing site request impact.
  Response: 2026 non-GAAP core spend profile is ~$200M, but annualized rate is ~$325M due to front-end loaded manufacturing support and R&D activities. Sanofi's decision to transfer tech transfer to a U.S. facility extends timeline but doesn't impact Novavax's cash runway or milestone likelihood.

• Question from Unknown Analyst (Cantor Fitzgerald): How much of 2026 Nuvaxovid uptake depends on contracting wins vs. pull-through, and how many MTAs are currently in place?
  Response: Contracting is crucial in the U.S. market (>90% retail pharmacy). Many MTAs are in place with ongoing expansions; recent signings include a new oncology company and an amendment with a major pharma company for another field.

• Question from Christopher LoBianco (TD Securities): What differentiated characteristics of Matrix-M attracted Pfizer? And what is the risk for Nuvaxovid from the upcoming ACIP meeting?
  Response: Cannot comment on Pfizer's specific rationale, but Matrix-M's flexibility across platforms and favorable reactogenicity are general attractions. Optimistic about a pathway forward for ACIP; ready to support Sanofi's commercial efforts.

• Question from Unknown Analyst (Citigroup): What informs timing for moving early pipeline (C. diff, shingles, RSV) into 2027, and could partnerships influence selection?
  Response: Goal is to advance at least one asset into clinic as early as 2027. Each program addresses unique unmet needs; partnerships are explored, but timing is not disclosed.

• Question from Unknown Analyst (Bank of America): Do current Matrix-M agreements apply to new adjuvant portfolio, and which pipeline program is ahead?
  Response: Existing agreements are exclusively for Matrix-M. New adjuvants would be Novavax IP. Each pipeline asset addresses different needs; development stages differ, but all are progressing towards potential 2027 clinic entry.

• Question from Xun Lee (H.C. Wainwright): Can we expect any milestones or data disclosures this year for the preclinical pipeline?
  Response: Will be cautious on data sharing for competitive reasons. Aiming to have one or more assets ready for IND submission this year, with regulatory readiness expected by early 2027.

Contradiction Point 1

Strategic Focus on Partnerships and Commercialization

Shift from seeking partnerships to dismissing co-promotes as a current focus.

Thomas Shrader (BTIG) - Thomas Shrader (BTIG)

20260226-2025 Q4: Current focus is on partnering and R&D, not commercialization or co-promotes. - [John Jacobs](CEO)

Are co-promote partnerships beneficial for revenue growth? - Unknown Analyst (Citi)

2025Q3: The intention is to partner out these pipeline assets, though Novavax retains the right to keep any 'home run' assets. - [John Jacobs](CEO)

Contradiction Point 2

Timeline for Non-GAAP Profitability

Revised target year for profitability based on partner program shifts.

Mayank Mamtani (B. Riley Securities) - Mayank Mamtani (B. Riley Securities)

20260226-2025 Q4: Encouraged by Sanofi’s public comments on their flu/COVID combination programs as key drivers for future growth. Regulatory review is expected in the 2027–2028 timeframe. - [John Jacobs](CEO)

How does the regulatory roadmap for respiratory vaccines (FDA, ex-U.S.) affect the valuation of your Phase III CIC and flu programs compared to Sanofi’s partnered program? - Alec Stranahan (BofA Securities)

2025Q3: The goal of driving the company to non-GAAP profitability remains a critical priority. The timing has been updated from 'as early as 2027' to 'as early as 2028' based on new information... - [James Kelly](CFO)

Contradiction Point 3

Strategy on Partnerships and Pipeline Focus

Contradiction on company's strategic focus regarding partnerships and commercialization.

Thomas Shrader (BTIG) - Thomas Shrader (BTIG)

20260226-2025 Q4: Current focus is on partnering and R&D, not commercialization or co-promotes. - [John Jacobs](CEO)

Are co-promotes attractive for partnerships? - Christopher Hue LoBianco (TD Cowen)

2025Q2: The goal is to unlock the value of its differentiated technology platform... by getting it into the hands of other innovators... which is seen as a significant growth opportunity in the $75B+ projected vaccine market. - [John Jacobs](CEO) and [James Kelly](CFO)

Contradiction Point 4

Status of Flu/COVID Combination Development

Contradiction on the readiness and regulatory path for flu/COVID combination vaccines.

Mayank Mamtani (B. Riley Securities) - Mayank Mamtani (B. Riley Securities)

20260226-2025 Q4: Regulatory review is expected in the 2027–2028 timeframe. - [John Jacobs](CEO)

How does the regulatory roadmap (FDA/ex-U.S.) for respiratory vaccines affect the valuation of your Phase III CIC and flu programs compared to Sanofi's partnered program? - Mayank Mamtani (B. Riley Securities)

2025Q2: The initial trial data (CIC and standalone flu) was generated to strengthen the safety/immunogenicity database and was not a registrational trial; a future registrational trial would be conducted by a partner once a collaboration is established. - [John Jacobs](CEO) and [Ruxandra Draghia-Akli](Head of R&D)

Contradiction Point 5

Regulatory Pathway for Nuvaxovid BLA and Post-Marketing Commitment

Contradiction on whether the post-marketing commitment is a requirement for BLA approval.

Mayank Mamtani (B. Riley Securities) - Mayank Mamtani (B. Riley Securities)

20260226-2025 Q4: Encouraged by Sanofi’s public comments on their flu/COVID combination programs... Regulatory review is expected in the 2027–2028 timeframe. - [John Jacobs](CEO)

How does the regulatory roadmap for respiratory vaccines (FDA, ex-U.S.) impact the valuation of your Phase III CIC and flu programs versus Sanofi’s partnered program? - Eric Joseph (JPMorgan)

2025Q1: Based on formal FDA communications, the requirement is for a post-marketing commitment, which by definition occurs *after* approval. - [Jim Kelly](CFO) and [John Jacobs](CEO)