Novavax Inc Q1 FY2025 Earnings Call

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

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 business development 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 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 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 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 multiyear 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 license 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 multiyear expense targets, we have highlighted a path towards our goal of non-GAAP profitability as early as 2027, and maintaining at least 1.5 years to 2 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 will see that beginning this quarter, we are highlighting 2 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 license partners. Under supply sales, we act as a contract manufacturer to our license 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 license 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 license 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 III CIC/Flu study and support of Sanofi for the upcoming COVID-19 vaccine season. A smaller portion of the 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. And 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 to $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 million 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 the 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 multiyear 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 $1,025 million. Our 2025 revenue framework excludes Sanofi 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; and third, a $50 million increase to adjusted licensing royalties and others that has 2 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 license partners and also a $20 million increase to amortization related to the Sanofi upfront payment in 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.

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.

Your first question comes from the line of Roger Song from 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 the 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 the 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. 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, as we mentioned, Novavax does not plan to take on further clinical investment in those late-stage programs independently. We are looking for a partner to collaborate with. Once we secure a partner, we will design the study together and disclose the study's design at that time. Our existing efficacy data for Nuvaxovid was based on an initial placebo-controlled trial involving approximately 30,000 patients. We have conducted this type of trial before with our products, but any new trial will be designed in partnership. That is our intention.

Yes. I ask this because your partner is running a Phase I/II trial with an active comparator involving Sanofi, with some data expected in the second half. My follow-up question concerns your earlier-stage pipeline. Ruxandra, could you provide insights on the timing of IND filings or the initiation of human clinical trials for the earlier-stage programs you've mentioned? Additionally, Jim can you comment on whether any of the early discussions regarding the partnered programs under MDA, which are currently under review, are reflected in your financial guidance?

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.

I believe you were inquiring about the timing for any INDs that may arise from our early-stage program. We haven't provided a specific timeline at this point, but a typical assumption can be made as we progress from the clinic. Additionally, we expect to offer more clarity in the second half of the year when we share some initial results from these programs. Jim, please proceed with 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 Zealand, is noncash. We had received that cash under those agreements in prior years. Of course, it was on our balance sheet. And then 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.

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 undertaken 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 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, we did not specifically design the study with reactogenicity as the primary focus. Instead, our aim was to demonstrate an immune response to both pathogens targeted by the vaccine. We will then evaluate the reactogenicity profile, which we anticipate to be reasonable given what we know about our technology. It's important to clarify that this study involves a 2,000-patient cohort and is not a pivotal trial or a full Phase III program. It is not intended for registration or to definitively prove anything long-term about our vaccine. The purpose of this small cohort is to provide additional data that can inform how we design a registration-targeted study with a partner, which is our intent. That’s the objective. Ruxandra, do you have anything to add?

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.

Do you have a filing with the FDA to update your vaccine? Is there any human data included in that filing regarding the updated vaccine, indicating that some people have received it and potentially to monitor immunogenicity? Or is there no human data for the updated vaccine?

Go ahead, John T.

Yes, I appreciate the clarification. It's crucial to understand the BLA submission and the review process. We're essentially seeking BLA approval for our current vaccine, which is already available under emergency use authorization. The basis for this BLA relies on the clinical data we've gathered so far; there is no new clinical data involved. It's based on our Phase III efficacy trial and any additional relevant information pertaining to that submission. Following the BLA approval and ongoing discussions with the FDA, we would be prepared for the market in 2025 and 2026, which may include a strain change. However, the immediate focus is the BLA for the current product without any new clinical data concerning the JN.1 strain. So, Tom...

Thank you, John. If we receive BLA approval, we will proceed accordingly. Until then, it’s still pending. Assuming we obtain that approval, subsequent filings will be made for an updated version of the vaccine to address the specific variant in question. There are upcoming meetings to provide guidance to the government on this matter, with VRBPAC scheduled for later this month, where recommendations regarding strain selection will be made. Companies will then submit updates for their vaccines. I hope we have understood your question and that this information is helpful.

Your next question comes from the line of Eric Joseph.

Is the discussion with the FDA regarding the approval of the COVID-19 vaccine solely focused on the requirements of the post-marketing commitment? I want to be sure that additional clinical work will not be a requirement for the initial BLA approval. Additionally, how does the approval milestone from Sanofi account for a post-marketing commitment? Specifically, will this milestone be affected if an additional clinical trial is needed as a condition for BLA approval?

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 seems that additional clinical trial work may be requested as a condition for approval. Are they asking for this before approval or as a condition afterwards?

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 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?

Yes, Chris, I can't comment on our level of confidence. However, I can share that we are currently collaborating with the FDA, and we see a potential path forward for approval based on our alignment regarding post-marketing commitments. As we gather more information, we will keep you updated.

Folks, it seems like that was our last question, and we seem to be having technical difficulty. So 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.