NVAX - NASDAQ

Good morning, and welcome to Novavax First Quarter 2025 Financial Results and Operational Highlights Conference Call. [Operator Instructions] 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.

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 2. 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 3. 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 4. 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. And 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.

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 1-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 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 health care 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 3 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 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 2 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. And 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. And we don't 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 influenza combination vaccine and stand-alone flu vaccine. And 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 2 major pharma companies, the initiation of 4 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?

Thank you, John. Please turn to Slide 6. It has been 6 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 a 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 4 early-stage programs after a rigorous prioritization process H5N1, RSV combinations, shingles, and C. difficile 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 CIC and Flu. Please turn to Slide 7. 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 vaccine adjuvated with Matrix-M have a milder reactogenicity profile compared to mRNA vaccines. Please turn to Slide 8. Furthermore, we presented the results of the SHIELD-Utah study at the Congress of the European Society of Clinical Microbiology and Infectious Disease Conference. This real-world study demonstrated that our protein-based technology platform outperformed one of the mRNA COVID vaccines across all parameters measured in terms of fewer and less severe reactogenicity symptoms with approximately 39 fewer symptoms on average and reduce 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 the 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 Neurometrix 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 antitumor responses. Please turn to Slide 9. 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. Nonhuman 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 lethal murine challenge model show complete protection in a similar vaccination regimen. Unlike other vaccines, which might require 2 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 United States and globally. Furthermore, additional exploratory data in the context of our COVID 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 created 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 don't 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 C. difficile, morbidity and mortality. There is no approved vaccine for C. difficile, yet the medical need is large with C. diff-related illness including recurrent infection. Our technology has the potential to facilitate the development of a multivalent adjuvated 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 stand-alone flu programs. In December 2024, we started an initial cohort of a Phase III immunogenicity and safety trial for our CIC and stand-alone 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 midyear. 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 evaluation. 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.

Well, 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

Thank you, Jim. In summary, we intend to drive long-term value creation through our corporate growth strategy. And in 2025, we'll continue to focus on our 3 strategic priorities: priority one, executing on our Sanofi partnership and in doing so, successfully demonstrating we are a partner of choice; priority 2, leveraging our technology platform and pipeline to forge additional partnerships; and priority 3, 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 Instructions] Your first question comes from the line of Roger Song of Jefferies.

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 2 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 and '26 season? And I have a follow-up question regarding the CIC.

Roger, thanks for the questions. We haven't commented publicly on the nature of the post-marketing commitment at this time. But as we've said a few times and we'll 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. And we do see a pathway forward to approval based on the formal comments and questions we've received from FDA. So we'll keep you posted as that develops. And 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.

That's fair. And then regarding the midyear data readout for your CIC program and the Flu, what is the target profile you're looking for and then to attract the partnership for the further development and the commercialization?

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 III program.

Thank you, John. So 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 III trial. So this is not an efficacy trial. Let me be very, very clear. It is to generate additional immunogenicity and safety data.

Yes, 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. And as we've said before, it's our intention to partner both our late-stage CIC and Flu assets out. That would be our intent.

Your next question comes from the line of Mayank Mamtani from B. Riley Securities.

Congrats on the progress. So 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 vaccine versus mRNA. And I was also curious, this talk on contemporary placebo-controlled study required, like how does that inform your thinking of what a registrational enabling Phase III trial would look like for your wholly-owned CIC and Flu vaccine? And I have a quick follow-up.

Mayank, I'll hand your 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?

That is correct. And how you're thinking of the bigger pivotal study for the CIC and Flu in context.

So Rux, why don't you take the first question, please?

Yes. Thank you, John. So let's be clear, the Utah study is an observational study, yes. So 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, yes. But after the introduction of any vaccine, actually, not only a COVID vaccine or a flu vaccine in the population, there are a lot of these real-world evidence studies that are looking at different characteristics. So that Utah study is in that particular category.

And then, Mayank, your next question had to do with were you asking about Phase III for our potential late-stage asset like our combination vaccine?

Right. That's right.

And whether or not it would be placebo-controlled?

Yes, just your thinking around what the vaccine efficacy study would look like after you've generated this immunogenicity data?

Well, we're 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. So we're currently seeking a partner. And if and when we get a partner, we'll be designing the study with them. And at that time, then 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. So we've done that before with our products, but any new trial would be designed with a partner. That's our intent.

Yes. And I ask that also since your partner is conducting a Phase I/II experiment with an active comparator, Sanofi with some data expected in the second half. And then maybe my follow-up question was on the -- 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've identified. And Jim can comment on whether some of these early discussions you're having for the partnered -- not the partner, but programs under MDA that are being reviewed, if any of that is included in your financial guidance framework?

Rux, why don't you take Mayank's question on the early-stage programs?

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

And then I think, Mayank, you were trying to ask about timing for any INDs that might come out of our early-stage program, but we haven't specified that at this time, but I think you'd use a normal assumptions on that when you're coming out of the clinic. And I think more -- 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 2.

And Mayank, 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. And the answer is no. Our revenue framework is based upon our existing agreements. So stay tuned. We're clearly working on that front.

Your next question comes from the line of Alec Stranahan of Bank of America.

Just 2 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 I've got a follow-up.

Jim, do you want to take that one?

Yes, certainly. And certainly, a good question. The APA revenue recognition, the $603 million from Canada and New

Okay. That makes sense. And then maybe just one question around the CIC readout middle of this year. Any bars for safety with the CIC that you see as being maybe key for partnership interest in the program? And is this maybe more important to view this versus each stand-alone component on its own or versus the other CIC vaccines that are in development?

Go ahead, Ruxandra.

So 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. And by and large, the safety, the tolerability, the reactogenicity profile of our vaccines are favorable, yes. So in this particular 2000 individual cohort aside from the immunogenicity data, we will also supplement our safety data. So for the moment, I think that this is not something that is different from what we have seen in the past. But of course, data will speak. And again, we will have in the second half of this year, additional data to share with you.

Your next question comes from the line of Tom Shrader of BTIG.

A very related question to the last one. Is the target profile of the combined vaccine is designed to make the reactogenicity about the same as stand-alone flu? Or is that inherently unrealistic because the COVID antigen is just reactogenic? Then I have a follow-up.

Tom, I wouldn't say we proactively designed the 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. And then we'll see how the reactogenicity profile looks. We would expect it to be reasonable based on what we know about our tech. And again, this -- we need to be crystal clear, 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 III 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. So that's the goal. Ruxandra, anything you'd add to that?

No, you said it all, John. Perfect.

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?

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.

So you have a filing in front of the FDA to update your vaccine, right? And 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?

Go ahead, John T.

Yes. I think 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 III 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 '25, '26 marketplace, which would include strain change. But 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. So Tom...

So assuming -- thank you, John. Assuming we get the BLA approval and when we have it, we'll have it. Until then, we don't have it. But 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. And then there's meetings upcoming to advise the government on that. VRBPAC was announced for later this month, et cetera, where they 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.

[Operator Instructions] Your next question comes from the line of Eric Joseph.

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? And then secondly, to what extent does the milestone -- 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?

Jim, why don't you take the milestone question first?

Yes, certainly. Eric, the milestone based upon BLA approval is not impacted by a post-marketing commitment. we are still eligible to receive upon BLA approval. Even with a post-marketing commitment, $175 million milestone.

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're clear.

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 [ indiscernible ]

All I can do is say what we've commented on publicly. Thank you for the question. And 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. And by definition, it's our understanding that a post-marketing commitment comes after approval and you've begun to market that product. So that's what we can share so far. That's what we've said so far. If anything changes, we'll let everybody know.

Your next question comes from the line of Chris LoBianco from Ed (sic) [ TD ] Securities.

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? And then I had one follow-up question.

Thank you, Chris, for your question. And I'd like to ask the question back to you because if you know, we'd love to find out. But 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.

And then just 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. And is it reasonable to expect an FDA decision near-term, i.e., in H1 2025?