Novavax - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 was a headline beat driven by one-time APA closeouts: revenue was $666.7M vs S&P Global consensus $343.9M*, and diluted EPS was $2.93 vs $1.41*; the upside primarily reflected $603M of non‑cash revenue recognized from terminating Canada/New Zealand APAs, while underlying commercial sales were modest.
• Management raised the FY2025 revenue framework to $975M–$1,025M (Adjusted Total Revenue), and reiterated combined R&D+SG&A guidance of $475M–$525M, citing added Nuvaxovid product sales, higher Matrix‑M supply demand, Takeda upfront, and Sanofi amortization timing.
• Strategic execution advanced: FDA feedback suggested a pathway to BLA approval contingent on alignment around a post‑marketing commitment (PMC) during the quarter; subsequently, on May 19 the FDA approved the BLA, triggering a $175M Sanofi milestone (post‑quarter catalyst).
• Cost discipline continued: combined R&D+SG&A fell 24% YoY in Q1; management reiterated a multiyear path toward potential non‑GAAP profitability as early as 2027, with quarterly net spend expected to decline over time.

What Went Well and What Went Wrong

What Went Well

• Raised FY2025 revenue framework to $975M–$1,025M driven by APA resolutions, supply sales, partner revenues (incl. $20M Takeda upfront), and amortization timing; maintained opex guidance, demonstrating operating discipline.
• Clear regulatory progress and future monetization: management said “FDA feedback on our BLA suggests a pathway to approval upon alignment on study parameters for the postmarketing commitment,” with $175M BLA milestone at approval; BLA approval subsequently arrived May 19 (post‑quarter).
• Cost structure improvement: SG&A down 45% YoY and combined R&D+SG&A down 24% YoY; CFO emphasized streamlining and a path to potential non‑GAAP profitability by 2027.

What Went Wrong

• Quality of revenue: $603M of Q1 product revenue stemmed from non‑cash APA terminations (Canada/New Zealand), masking modest underlying commercial sales ($5M U.S./Germany); Street models will likely adjust for non‑recurring items.
• Cash trended lower sequentially: cash, equivalents, marketable securities and restricted cash fell to $747M from $938M at YE’24 as liabilities were reduced and settlements paid; working capital improved but cash burn remains a focal point.
• Continued dependency on partners and regulatory timing: the 2025 revenue framework excludes Sanofi royalties and certain milestones due to reliance on Sanofi forecasts; a new PMC trial was anticipated around approval, potentially adding cost/complexity.

Transcript

Operator (participant)

Good morning and welcome to Novavax First Quarter 2025 Financial Results and Operational Highlights Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star followed by the number one on your touchstone phone. To withdraw your question, please press star followed by the number two. Please note this event is being recorded. I would now like to turn the conference over to Luis Sanay, Vice President, Investor Relations. Please go ahead.

Luis Sanay (VP of Investor Relations)

Good morning and thank you all for joining us today to discuss our First Quarter 2025 Financial Results and Operational Highlights. A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today. Please turn to slide two.

Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including but not limited to statements related to Novavax's corporate strategy and operating plans, its strategic priorities, its partnerships and expectations with respect to potential royalties, milestones, and cost reimbursements, FDA approval of the company's COVID-19 vaccine BLA, and alignment on the post-marketing commitment, its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine, the development of Novavax's clinical and preclinical product candidates, full year 2025 financial guidance and revenue framework, and Novavax's future financial business performance. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.

Additional information regarding these factors appears under the heading "Cautionary Note Regarding Forward-Looking Statements" in the presentation we issued this morning, and under the heading "Risk Factors" in our most recent Form 10-K and subsequent Form 10-Qs filed with the Securities and Exchange Commission available at sec.gov and on our website at novavax.com. The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements. Please turn to slide three. This presentation also includes references to non-GAAP financial measures, which are total adjusted revenue, and adjusted licensing, royalties, and other revenue, and non-GAAP profitability. Please turn to slide four. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter and highlight our growth strategy. Dr.

Ruxandra Draghia, Head of R&D, will discuss our R&D updates. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results and 2025 financial guidance and revenue framework. John Trizzino, Chief Operating Officer, will be available for the Q&A portion of the call. I would now like to hand over the call to John Jacobs.

John Jacobs (President and CEO)

Thank you, Luis. I'm pleased to be here with you today, along with members of our executive team, to discuss our financial results and highlight the progress we have made in Q1. This earnings call marks approximately the one-year anniversary of our new corporate growth strategy, which was formed after signing our agreement with Sanofi. Over the course of the past year, we have moved away from our prior focus, which was allocating the majority of our time, energy, and resources on commercializing our COVID-19 vaccine, to a strategy focused on optimizing our existing partnerships and expanding access to our proven technology platform via R&D innovation, organic portfolio expansion, and forging new partnerships and collaborations with other companies. We believe this strategy enables maximum value creation from our cutting-edge technology.

In parallel, we are creating a significantly leaner infrastructure, with continued cost reduction initiatives underway as we drive towards potential non-GAAP profitability as early as 2027. Via our new strategy, we intend to create multiple opportunities for value growth. Important catalysts this year include the potential approval of the BLA for our COVID-19 vaccine and other milestones related to the Sanofi agreement, preclinical data from our early-stage pipeline programs in the second half of this year, and the potential for additional partnerships and collaborations. As an example, we are excited about the progression of our partnership with Takeda, as it significantly improves the financial terms for Novavax in Japan, the third-largest healthcare market in the world. This strengthened partnership with Takeda, a globally respected multinational pharmaceutical company, further validates the value of our cutting-edge technology platform and our efforts to become a partner of choice.

Forging new collaborations and partnerships based on our differentiated tech platform and deep expertise in vaccine development is a top priority for us this year, and we look forward to sharing partnership updates with you as we continue to execute upon this key strategic pillar for Novavax. To guide our work for the remainder of 2025, we remain focused on three strategic priorities. Our first priority is optimizing our partnership with Sanofi. Our partnership with Sanofi is a prime example of how we intend to work with others as we look to become a partner of choice and create long-term value for our stakeholders. As we have said before, this partnership has many important and potentially value-creating elements to it, including milestones and royalties associated with the marketing of our COVID-19 vaccine, related to the BLA approval, MAH transfers, tech transfer, and ongoing royalties.

Number two, milestones and royalties associated with the development of new combination vaccines that include our COVID vaccine. For example, Sanofi is developing two combination vaccines that include our COVID vaccine and their market-leading flu vaccines, both of which earned fast-track designation from the FDA last year. Finally, milestones and royalties associated with any other new products developed using our Matrix-M adjuvant. Regarding our COVID vaccine, we are working constructively with the FDA with the intent of bringing the BLA process to a positive conclusion as soon as possible. FDA feedback on our BLA suggests a pathway to approval upon alignment on study parameters for the post-marketing commitment requested. We believe it's important that a non-mRNA protein-based COVID-19 vaccine option is available as a choice for U.S. consumers. Our second strategic priority is to leverage our proven tech platform and pipeline to drive additional partnerships.

Our team has been actively working on developing new partnership opportunities beyond Sanofi and the Material Transfer Agreement, or MTA, with a top-tier pharma company that we announced last fall to explore our Matrix-M adjuvant with bacterial pathogens. In fact, over the past few months, we have signed new agreements, including an expanded scope of the MTA I just mentioned to now include viral pathogens. We signed another new MTA for Matrix-M with a different top-tier pharma company, entered a preclinical collaboration with a new partner to explore the application and utility of Matrix-M with their cancer vaccine candidate, and, as noted earlier, strengthened our existing agreement with Takeda for the COVID market in Japan, including significantly improved financial terms for Novavax. These new agreements represent important steps in our continuing quest to add new partnerships throughout licensing efforts and further highlight the growing interest in our tech platform.

We intend to optimize these new agreements with the goal of expanding the scope and value creation opportunity for each of them over time. We do not intend to stop here. We are actively seeking additional partnerships and collaborations with the goal of creating multiple growth opportunities in the short, mid, and long term for Novavax. As we stated before, this ongoing effort includes seeking a potential partner to develop and commercialize our late-stage COVID-19 influenza combination vaccine and standalone flu vaccine. Finally, our third strategic priority is to advance our tech platform and early-stage pipeline. We are actively advancing our early-stage pipeline programs using a capital-efficient approach. Our R&D investment strategy should allow us to make disciplined investments in programs aligned to the highest potential value opportunities both within infectious disease and beyond. Our intent is to partner these assets at early proof-of-concept stages.

However, for the right asset, where data and commercial landscape indicate a unique high-value opportunity, we would consider bringing that asset forward ourselves, and we'll make that determination on a case-by-case basis as these assets mature. A bit later in the call, Ruxandra will talk about how we're using translational research and computational medicine to inform these investment decisions. We anticipate sharing some initial data on our new pipeline assets and new data on Matrix-M and our technology platform in the second half of the year during an investor day. In summary, over the past few months, we have made significant progress on our new growth strategy, including the addition of new agreements with other companies, the expansion and strengthening of existing agreements with two major pharma companies, the initiation of four new early-stage pipeline programs, and the continued advancement of our partnership with Sanofi.

We remain confident that over the long run, our technology has the opportunity to positively impact the lives of billions of people around the world, that our strategy has the potential to drive significant value creation, and that our team has the knowledge, poise, and skill to help carry us forward to an exciting and positive future for Novavax. I would now like to turn the call to Ruxandra to discuss our research and development updates. Ruxandra?

Ruxandra Draghia (EVP and Head of Research and Development)

Thank you, John. Please turn to slide six. It has been six months since joining Novavax's innovative R&D team, and this time left me even more excited about the potential of our technology platform and the opportunity we have to strengthen and build on the depth and breadth of our partnerships. As John mentioned before, an important part of our corporate growth strategy is value creation through the advancement of our early-stage pipeline and high-quality R&D. Value comes in different shapes and sizes. It starts in the lab, advancing programs and learnings, in a continuous cycle of generating scientific data, which in turn informs next projects and experiments with the goal of developing new vaccines and positively impacting public health. We have already accomplished a lot in a short time frame, and I'm encouraged and inspired by the depth, expertise, and skills of our team.

Since the start of the year, we initiated and advanced four early-stage programs after a rigorous prioritization process: H5N1, RSV combinations, shingles, and CDVCL, using information from translational models and leveraging artificial intelligence and machine learning. Furthermore, we continued our research into our COVID-19 vaccine and progressed our late-stage programs in kick and flu. Please turn to slide seven. We also continue to explore Matrix-M and its potential impact across a variety of vaccine platforms and pathogens, including new formulation of Matrix-M, generating data that demonstrate the utility of our adjuvant and sharing that with potential BD partners. Another example of us leading the way with science. In April, I presented at the World Vaccine Congress on the potential of Novavax's platform technology and Matrix-M adjuvant, showcasing attributes related to efficacy and tolerability.

Data collected and analyzed from multiple clinical trials show that vaccines adjuvanted with Matrix-M have a milder reactogenicity profile compared to mRNA vaccines. Please turn to slide eight. Furthermore, we presented the results of the SHIELD-Utah study at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Conference. This real-world study demonstrated that our protein-based technology platform outperformed one of the mRNA COVID-19 vaccines across all parameters measured in terms of fewer and less severe reactogenicity symptoms, with approximately 39 fewer symptoms on average, and reduced the impact of these symptoms on quality of life, such as daily work and family responsibilities. We believe that real-world information showing that a better tolerability and a milder reactogenicity profile will lead people to prefer our protein-based technology over other vaccine platforms when given the choice.

In early studies, we are seeking to explore how newer matrix formulations, different regimens and dosing schedules, and other enhancements to Matrix-M and its components could lead to improved vaccines, personalized approaches, and advancement in therapeutic areas beyond infectious diseases. As an example, we are currently developing research partnerships and collaboration in immuno-oncology, a field that is rapidly progressing and one where we envision exciting potential opportunities for our technology. By taking targeted risks, we expect to identify specific areas where Matrix-M, either as currently formulated or as a next-generation formulation, has the potential to improve rates and duration of anti-tumor responses. Please turn to slide nine. We have previously reported that we developed a protein nanoparticle and Matrix-M vaccine against highly pathogenic avian H5N1 virus that is currently undergoing preclinical evaluation.

Non-human primate studies have shown our candidate vaccine can produce protective levels of immunity after a single dose in primed animals, a situation like that of the human population which received a flu vaccine or had influenza in the past. A little murine challenge model showed complete protection in a similar vaccination regimen. Unlike other vaccines, which might require two or more doses for full protection, the possibility to administer a single vaccine dose for protection is important in the context of a pandemic, both in the U.S. and globally. Furthermore, additional exploratory data in the context of our COVID-19 vaccine have shown that our technology platform can induce mucosal antibodies. Mucosal protection is important not only for the person receiving the vaccine, but for instance, for reducing virus transmission.

Elements of our vaccine platform, its design, scale-up, and manufacturing processes should make a pandemic flu vaccine from Novavax amenable to rapid deployment as an alternative to mRNA vaccines. We stand ready to join the United States and global health security efforts related to H5N1 and are currently pursuing funding and partnership opportunities for this program. Our new programs across our discovery portfolio are using artificial intelligence and machine learning-enabled structure-driven optimization, rapid antibody testing for epitope assessment, and novel in vitro and in vivo models for rapid preclinical testing. Our early-stage pipeline includes development of an RSV combination vaccine candidate that builds on the company's extensive history in this area.

Lessons learned regarding superior protein antigen design, together with the new computational capabilities mentioned before, should allow us to enhance structural stability and immunogenicity and combine multiple different respiratory virus antigens with Matrix-M into this program, potentially creating a competitive, meaningful, and differentiated offering in this key area. For shingles prevention, we believe our technology has the potential to improve on the current standard of care by enabling a more tolerable, less reactogenic, equally efficacious vaccine. Many at-risk adults are declining shingles protections or do not complete their vaccination series because of the fear of side effects. By providing a more attractive option regarding tolerability, which we believe our technology has the potential to do, we intend to change this dynamic and address a persistent public health need. We believe our technology may lead to better vaccine candidates for the prevention of CDVCL morbidity and mortality.

There is no approved vaccine for CDVCL, yet the medical need is large with CDV-related illness, including recurrent infection. Our technology has the potential to facilitate the development of a multivalent adjuvanted vaccine with enhanced activity that could provide a differentiated impact in an underserved patient population. We expect to share some initial data and early learnings on our early-stage organic pipeline during the second half of the year. Turning to our late-stage CIC and standalone flu programs. In December 2024, we started an initial cohort of a phase three immunogenicity and safety trial for our CIC and standalone influenza vaccine candidates in older adults. This trial completed enrollment of approximately 2,000 participants, and we are on track to report top-line data mid-year. While not a pivotal study, this data will be essential to inform the design of a subsequent pivotal trial in older adults for both programs.

In addition, after further consultation with the U.S. FDA, we determined that seeking an accelerated approval pathway for either of these assets would not be feasible. We intend to partner both vaccine programs and have the potential partner advance and fund all future clinical development, regulatory filing, and commercialization activities. In summary, now, with an intense focus on science and readiness for partnering, we intend to advance and optimize our programs and generate initial proof of concept in preclinical evaluations. I'm very much looking forward to sharing with you some of our first data readouts in the second half of this year. I'll turn the call over to Jim to discuss our financial results.

Jim Kelly (CFO and Treasurer)

Thank you, Ruxandra. Please turn to slide 10. This morning, we announced our financial results for the first quarter of 2025.

Details of our results can be found in our press release issued today and in our Form 10-Q filed with the SEC. Before reviewing our financial results, I would like to begin by noting that today we are reiterating our financial guidance for full year 2025, combined R&D and SG&A expenses, and raising our 2025 revenue framework. Last quarter, we outlined Novavax's path to significant value creation and potential non-GAAP profitability, and we are focused on the execution of this plan. More on these points later in my remarks. Please turn to slide 11. I'll begin with key highlights from our first quarter 2025 financial results. Novavax reported total revenue of $667 million as compared to $94 million in the first quarter of 2024.

The $622 million of product sales in the current quarter includes $603 million recognized in connection with the termination of the Canada and New Zealand APA agreements. Both of these agreements are now fully closed, and the revenue recognized relates to cash received in prior years. In addition, we recorded $45 million from licensing, royalties, and other revenue. During the first quarter of 2025, we continued to transform Novavax into a more lean and agile organization. We strengthened our balance sheet, reducing our current liabilities by over 60% compared to year-end 2024, and improved our cost structure by reducing combined R&D and SG&A costs by 24% compared to the same period last year. For 2025, we are reiterating our full-year financial guidance for combined R&D and SG&A expenses of between $475 million and $525 million. At the midpoint, this reflects a 30% reduction when compared to 2024.

Of note, we continue to work with FDA on the parameters of the requested post-marketing commitment study related to our BLA. For now, we believe it should be assumed that our multi-year guidance includes the potential impact to Novavax of this post-marketing commitment. If needed, our guidance and operating plan may be updated based upon the outcome of that discussion. In parallel, we are working closely with our partner, Sanofi, to determine the potential approach to funding. We ended the first quarter with just under $800 million in cash and receivables. During 2025, we anticipate earning an additional $225 million in milestones from Sanofi, assuming Nuvaxovid approval in the U.S. and Europe, and a $20 million upfront payment in the second quarter from Takeda related to our amended license agreement.

These anticipated cash flows from our licensed partners highlight Novavax's potential to create significant shareholder value by monetizing our cutting-edge technology. Based on our current operating plan, including milestone payments, royalties, and the multi-year expense targets, we have highlighted a path towards our goal of non-GAAP profitability as early as 2027 and maintaining at least a year and a half to two years of cash on hand at all times. Please turn to slide 12 for a detailed view of our first quarter revenue results and disclosures. You'll see that beginning this quarter, we are highlighting two categories under product sales. Nuvaxovid reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of our COVID-19 vaccine. This is where we historically have recorded our APA and commercial market sales.

New, beginning in 2025, is a category called supply sales that includes sales of finished product, Matrix-M adjuvant, and other supplies to our licensed partners. Under supply sales, we act as a contract manufacturer to our licensed partners to support their development and sales of vaccines to customers around the world, leveraging our proven technology. In prior years, we recorded the supply sales under licensing, royalties, and other as they were less material at that time. For the first quarter of 2025, we recorded total revenue of $667 million compared to $94 million in the same period in 2024. Product sales for the first quarter of 2025 were $622 million, driven by $603 million of revenue related to the closeout of the Canada and New Zealand APAs.

In each case, this resolution allows Novavax to retain cash previously received under these agreements and resolves any outstanding obligation via payments of $28 million and $4 million to Canada and New Zealand, respectively, in the first quarter. The remaining $5 million for Nuvaxovid product sales in the first quarter relates to sales in the U.S. and Germany. Our supply sales of $14 million in the first quarter of 2025 were primarily related to Matrix-M adjuvant sales to our licensed partners. We recorded $45 million of licensing, royalties, and other revenue in the first quarter, consisting of $40 million related to our Sanofi agreement and $5 million from royalties from our other licensed partners. The Sanofi revenue consists of $29 million from the amortization of our upfront payment and database lock milestones, plus $11 million from R&D reimbursements in the period as we support Sanofi in their efforts.

Please turn to slide 13 for a detailed view of our first quarter financial results, where I'll focus on our operating expense results and trends. First quarter 2025 combined R&D and SG&A expenses were $137 million and reflect a 24% reduction from the same period in 2024. Importantly, our SG&A expense of $48 million is 45% lower than the same period last year and is driven by the decrease in closeout of our global sales and marketing capabilities, plus strong execution on our broader cost reduction plan. Research and development expenses of $89 million in the first quarter of 2025 were primarily driven by our investments in the phase three kid flu study and support of Sanofi for the upcoming COVID-19 vaccine season. A smaller portion of this spend is presently directed towards our early-stage preclinical programs.

We intend to focus our attention on partnering our CIC and flu vaccine candidates, and this study reflects the material completion of our intended investments in this program. Finally, we reported net income of $519 million, or $2.93 per diluted share, for the first quarter of 2025. Please turn to slide 14. Our first quarter 2025 results highlight the significant progress we have made this year to improve our balance sheet by reducing current liabilities by $732 million. Since 2022, we have reduced Novavax's current liabilities by $2.1 billion and over 80%. During the first quarter, our change in cash of approximately $250 million included the elimination of many short-term liabilities, and we expect our go-forward expenditures to be lower.

Specifically, we anticipate our expenditure rate, which reflects our net spend prior to new cash flows from royalties and milestones, to be in the $140 million-$160 million range per quarter and declining over time. We believe this progress places Novavax in a stronger financial position as we execute on our growth strategy. Please turn to slide 15. We are committed to streamlining our operating expenses to enable value creation. For 2025, we are reiterating our full-year combined R&D and SG&A expense guidance of between $475 mllion and $525 million. We intend to invest approximately 70% of this combined spend into R&D to drive shareholder value as we allocate our resources towards what we believe are the highest return activities.

During 2025, we expect our operating expenses to be highest in the first half of the year as we conclude our CIC flu study and then decline through the second half of the year. Looking forward, we expect to achieve combined R&D and SG&A expenses of approximately $250 million in 2027 and believe we are well on our way to achieving this goal. As mentioned earlier, we continue to work with FDA on the parameters of the requested post-marketing commitment study. For now, it should be assumed that our multi-year guidance includes the potential impact to Novavax of this post-marketing commitment. Reducing our cost structure is an important piece of our drive towards non-GAAP profitability as early as 2027. We define non-GAAP profitability as GAAP operating profit less non-cash items such as stock-based comp and depreciation.

Keys to the timing on our path to profitability are the successful development, regulatory approval, and commercialization of products by our partner Sanofi under our agreement. Please turn to slide 16. Now turning to our 2025 revenue framework. Today, we are raising our prior revenue framework and now expect to achieve adjusted total revenue of between $975 million and $1.25 billion. Our 2025 revenue framework excludes Sanofi's supply sales, royalties, and influenza COVID-19 combination and Matrix-M related milestones. This means there may be revenue in 2025 that is additive to our expectations for adjusted total revenue for the year. At midpoint, the $675 million increase to our 2025 adjusted total revenue is driven by, first, the addition of $610 million of Nuvaxovid product sales that includes our first quarter results and a small amount of sales in the second quarter of 2025.

Second, a $15 million increase to adjusted supply sales related to increased demand for Matrix-M from Serum for the R21 malaria vaccine and from Takeda for COVID-19. Third, a $50 million increase to adjusted licensing, royalties, and others that has two components. A $30 million increase to other partner revenue driven by a $20 million upfront payment from Takeda in the second quarter and anticipated milestones and royalties from our licensed partners. Also, a $20 million increase to amortization related to the Sanofi upfront payment and pediatric milestone. This reflects a timing update that shifts amounts into 2025 that were previously anticipated to be recorded in 2026. We look forward to sharing additional updates as we improve Novavax's financial performance, cost structure, and strength to deliver shareholder value. With that, I'd like to turn the call back over to John for some closing remarks.

John Jacobs (President and CEO)

Thank you, Jim.

In summary, we intend to drive value creation through our corporate growth strategy, and in 2025, we'll continue to focus on our three strategic priorities. Priority one, executing on our Sanofi partnership, and in doing so, successfully demonstrating we are a partner of choice. Priority two, leveraging our technology platform and pipeline to forge additional partnerships. Priority three, advancing our tech platform and early-stage pipeline to help foster additional partnering and growth opportunities. Thank you all for joining us today, and thank you to all of our employees for their continued efforts in advancing our business. I'm proud of our accomplishments to date and excited about the opportunity to drive future value from our strategy in 2025 and beyond. I'd now like to turn the call over to our operator for Q&A. Operator?

Operator (participant)

Thank you. We will now begin the question and answer session. To ask a question, you may press star followed by the number one on your touchstone phone. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star followed by the number two. At this time, we will pause momentarily to assemble our roster. Your first question comes from the line of Roger Song of Jefferies. Your line's now open.

Roger Song (Equity Analyst)

Great. Good morning. Thanks for the update and taking our question. A couple of questions from us. The first one is regarding this post-marketing commitment FDA requested. Can you just comment on the nature of the study in terms of the efficacy versus safety requirement? And then also, we just know in two weeks, VRBPAC is going to host a meeting to select the strain for the 2025-2026 season.

How do you think this post-marketing commitment is going to impact the 2025-2026 season? I have a follow-up question regarding the CIC. Thank you.

John Jacobs (President and CEO)

Hi, Roger. Good to hear from you, and thanks for the questions. We have not commented publicly on the nature of the post-marketing commitment at this time, but as we have said a few times and we will continue to say today, right now, we continue to work with the FDA diligently and urgently to try to bring this forward as soon as possible to a positive conclusion. We do see a pathway forward to approval based on the formal comments and questions we have received from FDA. We will keep you posted as that develops.

Right now, we're not seeing a direct impact on any discussions VRBPAC may be having on the season related directly or indirectly to any requests we may have had in our BLA.

Roger Song (Equity Analyst)

Got it. That's fair. Regarding the mid-year data readout for your CIC program and the flu, what is the target profile you're looking for to attract the partnership for the further development and the commercialization? Thank you.

John Jacobs (President and CEO)

All right. I'll hand that question over to Ruxandra. Roger, and if we heard you right, you were asking about the nature of that data or what we're expecting or hoping to see in that cohort, Ruxandra, of our phase three program.

Ruxandra Draghia (EVP and Head of Research and Development)

Thank you, John. As I have mentioned in my intervention, we have enrolled a first cohort of approximately 2,000 individuals in this CIC and flu study.

We are looking for immunogenicity and safety data that could complement what we already have from our previous studies that would help design a phase three trial. This is not an efficacy trial, let me be very, very clear. It is to generate additional immunogenicity and safety data.

John Jacobs (President and CEO)

Yeah, it's not a pivotal trial, Roger, right? It's a learning data set to help further inform what may be required for a full licensure with a partner. As we've said before, it's our intention to partner both our late-stage kick and flu assets out. That would be our intent.

Roger Song (Equity Analyst)

Got it. Yep. Thank you.

Operator (participant)

Thank you. Your next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line's now open.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Yes. Good morning, team. Thanks for taking our questions and congrats on the progress. Yeah. Thanks, John.

I was wondering, in context of this Utah SHIELD study that was published, I was just curious how much is this quality of life, activities of daily living kind of factored in regulatory science as FDA as well as global regulators think of adjuvanted protein-based vaccines versus mRNA? I was also curious, this talk on contemporary placebo-controlled study required, how does that inform your thinking of what a registration-enabling phase three trial would look like for your wholly owned kick and flu vaccine? I have a quick follow-up.

John Jacobs (President and CEO)

Mike, I'll hand that first question over to Ruxandra. If we heard you correctly, if we understand your question right, you're asking about the impact that data from our SHIELD study, that type of data may have on the opinions of regulators around the world. Did we hear you correctly?

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

That is correct. How you're thinking of the bigger pivotal study for the CIC and flu in context of that.

John Jacobs (President and CEO)

Okay. Rux, why don't you take the first question, please? Thank you.

Ruxandra Draghia (EVP and Head of Research and Development)

Yeah. Thank you, John. Let's be clear. The Utah study is an observational study, yeah? Basically, based on a questionnaire asking about the quality of life of individuals. This is not part of a typical regulatory submission. It is to inform probably much more the consumers rather than the regulators. We cannot speculate how the regulators are going to look at that particular data. They are actually looking at the safety and efficacy of each of the vaccines on their own merit, yeah?

But after the introduction of any vaccine, actually, not only a COVID-19 vaccine or a flu vaccine in the population, there are a lot of these real-world evidence studies that are looking at different characteristics. That Utah study is in that particular category.

John Jacobs (President and CEO)

Thank you, Ruxandra. Mayank, your next question had to do with, were you asking about phase three for our potential late-stage asset like our combination vaccine?

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Right. That's right.

John Jacobs (President and CEO)

And whether or not it would be placebo-controlled?

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Yeah. Just your thinking around what the vaccine efficacy study would look like after you've generated this immunogenicity data.

John Jacobs (President and CEO)

We are going to be again, as we said, Novavax does not intend to take on ourselves further clinical investment in those late-stage programs. We intend to do that with a partner. We are currently seeking a partner.

If and when we get a partner, we'll be designing the study with them. At that time, we will be disclosing how that study is designed. When it comes to placebo-controlled, our existing efficacy data for Nuvaxovid was based upon an initial placebo-controlled trial with approximately 30,000 patients. We have done that before with our products, but any new trial would be designed with a partner. That is our intent.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Yeah. I ask that also since your partner is conducting a phase one two experiment with an active competitor, Sanofi, with some data expected in second half. Maybe my follow-up question was on your earlier stage pipeline. If you could comment, Ruxandra, back to you on the order of IND filings or human clinical trial starts for these earlier stage programs you have identified.

Jim can comment on whether some of these early discussions you are having for the partner, not the partner, but programs under MTA that are being reviewed, if any of that is included in your financial guidance framework. Thanks for taking our questions.

John Jacobs (President and CEO)

Rux, why do you not take Mike's question on the early-stage programs?

Ruxandra Draghia (EVP and Head of Research and Development)

The definition of an early-stage program is that it is early, yeah? We are actually very diligently working on generating very rigorous preclinical data on each of the programs that I have mentioned. We will be happy to share with you and with the external stakeholders data in the second half of the year. I cannot comment on each and every one of the programs of exactly where we are. It is preclinical. By nature, it is evolving practically every day. Sometimes we have results twice a day.

Stay tuned for the second half of the year.

John Jacobs (President and CEO)

I think, Mike, you were trying to ask about timing for any INDs that might come out of our early-stage program, but we have not specified that at this time. I think you would use normal assumptions on that when you are coming out of the clinic. I think that will be more clear also in the second half of the year as we share some initial results on these programs. Go ahead, Jim, on question two.

Jim Kelly (CFO and Treasurer)

Mike, I think the final piece is you were asking whether or not any yet to be entered into agreements are factored or included in our revenue framework. The answer is no. Our revenue framework is based upon our existing agreements. Stay tuned. We are clearly working on that front.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Thanks for taking our questions and look forward to those updates.

Operator (participant)

Thank you. Your next question comes from the line of Alex Stranahan of Bank of America. Your line's now open.

Alec Stranahan (VP and Senior Analyst in Equity Research)

Hey, guys. Thanks for taking our questions. Just two from me. Maybe just starting on the APA revenues that got recognized this quarter. I guess how much of this is maybe cash today versus cash in the future? Or is it basically all of it just revenue recognition of prior cash that's been received? And then that's going to follow up.

John Jacobs (President and CEO)

Jim, you want to take that one?

Jim Kelly (CFO and Treasurer)

Yeah, certainly. And certainly a good question. The APA revenue recognition, the $603 million from Canada and New Zealand, is non-cash. We had received that cash under those agreements in prior years. Of course, it was on our balance sheet.

Through the termination and closeout of those agreements, what that meant is that we get to keep that cash under the closeout of those agreements.

Alec Stranahan (VP and Senior Analyst in Equity Research)

Okay. That makes sense. Maybe just one question around the kick readout middle of this year. Any bars for safety with the kick that you see as being maybe key for partnership interests in the program? Is this maybe more important to view this versus each standalone component on its own or versus the other kick vaccines that are in development? Thank you.

John Jacobs (President and CEO)

Go ahead, Ruxandra.

Ruxandra Draghia (EVP and Head of Research and Development)

As I have mentioned, we have presented the data coming from a multitude of clinical trials that we have undertook with our vaccine platform and with the Matrix-M adjuvant at the World Vaccine Conference. By and large, the safety, the tolerability, the reactogenicity profile of our vaccines are favorable, yeah?

In this particular 2,000 individual cohort, aside from the immunogenicity data, we will also supplement our safety data. For the moment, I think that this is not something that is different from what we have seen in the past. Of course, data will speak. Again, we will have in the second half of this year additional data to share with you.

Alec Stranahan (VP and Senior Analyst in Equity Research)

Thank you. Thank you.

Operator (participant)

Your next question comes from the line of Tom Shrader of BTIG. Your line's now open.

Tom Shrader (Managing Director and Healthcare Analyst)

Good morning. Thanks for the detailed call. A very related question to the last one is the target profile of the combined vaccine, is the design to make the reactogenicity about the same as standalone flu, or is that inherently unrealistic because the COVID antigen is just reactogenic? I have a follow-up.

John Jacobs (President and CEO)

Tom, I would not say we proactively designed a study based on reactogenicity.

We designed it to demonstrate an immune response to both of the pathogens that are being targeted with that vaccine, as you're well aware. We will see how the reactogenicity profile looks. We would expect it to be reasonable based on what we know about our tech. Again, we need to be crystal clear and make sure everyone, what I want everyone to understand is this is a 2,000-patient cohort. This is not a pivotal trial. This is not a full phase three program. This is not designed for registration. This is not designed to definitively prove anything long-term about our vaccine. What it is designed to do as a small cohort is to add additional data into our data set to help us think about how to then design, with a partner, which is our intent, a study that would be targeted toward registration.

That's the goal. Ruxandra, anything you'd add to that?

Ruxandra Draghia (EVP and Head of Research and Development)

No. You said it all, John. Perfect. Thank you.

John Jacobs (President and CEO)

Thank you. Thanks for the question.

Tom Shrader (Managing Director and Healthcare Analyst)

If I can ask a follow-up about the filing for your updated vaccine that's in front of the FDA now, how much human data is in there from the updated vaccine? Is it none, or is there a cohort for immunogenicity? What has the FDA seen in terms of data of this exact vaccine in people? Thanks.

John Jacobs (President and CEO)

Sorry, Tom. We just want to make sure we fully understand your question. Could you just clarify, just take a shot at clarifying that, and then Ruxandra will try to answer you.

Tom Shrader (Managing Director and Healthcare Analyst)

You have a filing in front of the FDA to update your vaccine, right?

The question is, is there any human data in that filing with the updated vaccine so they would have some sense that some number of people have seen the vaccine and probably to monitor immunogenicity? Or is there no human data for the actual updated vaccine?

John Jacobs (President and CEO)

I see. Go ahead, John T.

John Trizzino (COO)

Yeah. Hi. Thanks for the clarification. I think it's important to understand what the BLA submission is and what's being reviewed. It's taking the existing product that's in market today under the emergency use authorization and getting a BLA approval for that vaccine, right? Remember, the basis for that BLA is on the clinical data to date. There's no new clinical data. It's from our phase three efficacy trial and any other updated information that was relative to that filing.

We then, after the approval of the BLA and some of the conversations we're having with FDA today, would result in then a readiness for the 2025, 2026 marketplace, which would include strain change. First step, again, just to be clear, is the BLA for the existing product with no new clinical data relative to the JN.1 strain. Assuming, thank you, John. Assuming we get the BLA approval. When we have it, we'll have it. Until then, we don't have it. Assuming we get that, then you'd make subsequent filings, to your point, for an updated version of the vaccine to target whatever variant we'd be targeting. There are meetings upcoming to advise the government on that. VRBPAC was announced for later this month, etc., where they'd make recommendations on that strain selection, and then companies will be making submissions to update their vaccines.

Hopefully, we've understood your question clearly, and that was helpful.

Tom Shrader (Managing Director and Healthcare Analyst)

Absolutely. Thank you very much.

Operator (participant)

Again, if you have a question, please press star followed by the number one on your touchstone phone. Your next question comes from the line of Eric Joseph. Your line's now open.

Eric Joseph (Biotech Analyst)

Hi. Good morning. Thanks for taking the questions. As a condition of approval for the COVID-19 vaccine, is the discussion with FDA solely focused on the shape of the post-marketing commitment? I just want to be confident that we can rule out additional clinical work being a condition for initial BLA approval. Then secondly, to what extent does the approval milestone from Sanofi consider a post-marketing commitment? I guess what I mean to ask there is whether that milestone may be impacted at all if an additional clinical trial is required as a condition of BLA approval. Thank you.

John Jacobs (President and CEO)

Jim, why do not you take the milestone question first?

Jim Kelly (CFO and Treasurer)

Yeah, certainly. Eric, the milestone based upon BLA approval is not impacted by a post-marketing commitment. Eric, we want to make sure. Right. You are still eligible to receive upon a BLA approval, even with a post-marketing commitment, $175 million milestone.

John Jacobs (President and CEO)

Thank you, Jim. And then, Eric, your other question, we just want to make sure we understand clearly. So are you asking, have we been asked to generate a new clinical study that would be required prior to a potential BLA approval and afterwards? Is that your question? We just want to make sure we are clear.

Eric Joseph (Biotech Analyst)

It sounds like additional clinical trial work is possibly being requested as a condition of approval. Is that being asked for before approval, or is it being asked as a condition?

John Jacobs (President and CEO)

All I can do is say what we have commented on publicly.

Thank you for the question. If folks have that on their mind, we hope to make it as clear as we can at this moment in time. Based on what we've received to date formally from FDA, they're asking for a post-marketing commitment. By definition, it's our understanding that a post-marketing commitment comes after approval and you've begun to market that product. That's what we can share so far. That's what we've said so far. If anything changes, we'll let everybody know.

Eric Joseph (Biotech Analyst)

Great. Thanks for taking the questions.

Operator (participant)

Thank you. Your next question comes from the line of Chris LoBianco from TD Securities. Your line's now open.

Chris LoBianco (VP and Equity Research Analyst)

Thank you for taking our question this morning. First, to the best of your knowledge, is the post-marketing clinical trial requirement specific to Novavax's BLA filing?

Or do you expect FDA will ask all COVID-19 vaccines, including the mRNA vaccines, to generate efficacy data for booster doses in a broad population with pre-existing immunity? I had one follow-up question. Thank you.

John Jacobs (President and CEO)

Thank you, Chris, for your question. Good to hear from you. I'd like to ask the question back to you because if you know, we'd love to find out. No. In all seriousness, we really can't speculate on FDA's thoughts regarding other companies' filings. We know that we have our conversations ongoing with FDA, and that's all we can comment on at this time, Chris.

Chris LoBianco (VP and Equity Research Analyst)

Great. My follow-up question is, has your confidence in receiving FDA approval of the BLA in 2025 increased, decreased, or remained the same since the Q4 call in February 2025?

Is it reasonable to expect an FDA decision near term, i.e., in H1 2025? Thank you.

John Jacobs (President and CEO)

Yeah. Chris, I'm not going to comment on a score on where our confidence is, but what I can do is share with you what we've already said publicly, which is that we're working right now with FDA, and we see a potential pathway forward for approval based on alignment on our post-marketing commitment. As we learn more, we'll let you know. Operator? Operator? Folks, it seems like that was our last question, and we seem to be having technical difficulty. I would like to thank everyone for joining us today and note that we'll be ending the call at this time. Thank you again for your time and questions. Have a great day, everyone.