Novavax, Inc. Q4 FY2025 earnings call

• John Jacobs highlighted progress on corporate strategy in 2025, including new agreements with Pfizer, reshaping the company from a vertically integrated COVID-focused entity to a partnership-driven one, and financial stabilization with over $800 million in non-dilutive capital earned in 18 months.
• Elaine O'Hara discussed business development efforts, including active partnering with multiple pharmaceutical companies, progress on existing partnerships like with Pfizer and Sanofi, market share gains for Nuvaxavid and R21 Matrix M Malaria vaccine, and rationalization of facilities.
• Roxandra Draghia talked about R&D efforts, including expanding in-house R&D in infectious diseases with programs like C. diff, shingles, and RSV triple combination, driving lifecycle management and innovation for the Matrix-based adjuvant platform, and the impact of technology via partners with marketed products and ongoing partnering discussions.
• Jim Kelly reviewed financial results, noting 2025 adjusted total revenues met and exceeded guidance, reduced combined R&D and SG&A spend, and provided 2026-2028 financial guidance and expense targets, including cash runway into 2028 and non-GAAP P&L profitability target as early as 2028.

In 2025, total revenue was $1.1 billion, a 65% increase year over year. Fourth quarter 2025 revenue was $147 million, a 67% increase year-over-year. Non-GAAP adjusted total revenues were $1.1 billion, approximately $50 million higher than the midpoint of the revenue framework range. Combined R&D and SG&A was approximately $500 million, approximately 20 million favorable to the midpoint of guidance. Novaccevid product sales were split between Israel APA deliveries and Novavax sales to other global markets. Supply sales reflected Novavax finished goods sales to Sanofi and MatrixM adjuvant sales to partners. Sanofi licensing, royalty, and other revenue was driven by milestones and R&D cost reimbursement. Nuvaxavid had market share gains in Japan and the R21 Matrix M Malaria vaccine had significant distribution for malaria fight.

2026 adjusted total revenue expected between $230 million and $270 million, including Nivaxavid product sales, supply sales, licensing, royalties, and other revenue. 2028 combined R&D and SG&A expense guidance $200 million or below. 2026-2027 combined R&D and SG&A expense guidance improved by $25 million each year to $325 million and $225 million respectively at midpoint. Anticipated significant growth in Novavax royalties in 2026 as Sanofi can compete effectively. Excluding certain milestones from revenue framework for now due to timing impact evaluation.

The current macro and regulatory environment in the United States poses significant uncertainties for vaccine companies. Risks related to forward-looking statements, including actual results differing from projected due to various factors like clinical trial timing, regulatory filings, market opportunity, etc. Uncertainties around the timing and outcome of Sanofi's tech transfer request and its impact on milestones. Risks associated with the development and commercialization of in-house pipeline assets, including competitive landscape, regulatory hurdles, and market acceptance.

Q: Roger Song with Jefferies asked about Sanofi's new CEO, COVID sales expectation for 2026, and early pipeline prioritization.

A: New CEO not in place yet, positive relationship with Sanofi. Upcoming COVID season looks promising with Sanofi's plans. Early pipeline programs like C. diff, shingles, RSV triple combination are advancing, with aim to move into clinic as early as 2027.

Q: Tom Schrader with BTIG asked about co-promotes for Matrix M and development of tweaked Matrix M for cancer vaccine.

A: Core focus is on partnering and R&D for matrix adjuvant portfolio, open to co-promote if a game-changer emerges. Tweaked Matrix M is being developed for specific immune responses, with in-house work and potential partnership in oncology.

Q: Anupam Rama with J.P. Morgan asked about color on expanded Matrix-M partnerships and time horizon for MTAs to formal partnerships.

A: Active in partnering with multiple companies, MTAs at different stages, timeline TBD as it depends on partner's development. Data generation and R&D efforts facilitate partnering discussions.

Q: Mayank Mamtami with B. Reilly Securities asked about respiratory vaccines FDA and XUS regulatory roadmap, and comparing own clinical stage programs with Sanofi's.

A: Pleased with partners' progress on combination vaccines, encouraged by Sanofi's public comments and regulatory review expected in 27-28 timeframe. Sanofi's programs show potential value of Novavax's platform.

Q: Pete Stavropoulos with Cantor Fitzgerald asked about Novavaxivid uptake assumption and number of MTAs.

A: Contracting matters in US COVID distribution, Sanofi in full cycle negotiation. Multiple MTAs in place, with new ones signed recently, showing strong interest in Matrix M.

Q: Chris Lobianco with TD Securities asked about Matrix's differentiating factors for Pfizer and risk over ACIP meeting.

A: Pfizer's specific reasons confidential, but Matrix has flexibility and favorable reactogenicity. Optimistic about ACIP meeting and pathway forward, with data showing vaccinated individuals have lower risk of long COVID.

Q: Jeff Meacham with Citigroup asked about early pipeline timing and partnership influence.

A: R&D focusing on matrix adjuvant portfolio, aim to move early stage assets into clinic as early as 2027. Partnerships can influence expediency, with R&D generating data for partnering opportunities.

Q: Alec Stranahan with Bank of America asked about MatrixM agreements and pipeline prioritization.

A: Signed agreements focus on Matrix M, new adjuvants if developed would be Novavax's IP. Pipeline assets address different medical needs, TPP evolving as ecosystem evolves.

Q: Sean Lee with HC Wainwright asked about early pipeline data disclosures.

A: Making excellent progress in preclinical work, cautious about competitive disclosure, but intent to share data as appropriate, with aim to move into clinic as early as 2027.