Novavax Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2024

There are 9 speakers on the call.

Operator

Good morning, and welcome to Novavax Second Quarter 2024 Financial Results and Operational Highlights Conference Call. Please note this event is being recorded. I would now like to turn the call over to your speaker today, Erica Schultz, Senior Director, Investor Relations. Please go ahead.

Speaker 1

Good morning and thank you all for joining us today to discuss our Q2 2024 operational highlights and financial results. 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 information relating to the future of Novavax, its key strategic priorities, statements related to potential royalties and milestones, operating plans, objectives and prospects full year 2024 financial guidance the amount and impact of Novavax's cost reduction plans, its future financial or business performance conditions or strategies, its partnerships, anticipated timing and outcome of future regulatory filings and actions and the ongoing development, marketing opportunities, manufacturing capacity and future availability of our vaccine candidates and key upcoming milestones. 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.

Speaker 1

Additional information regarding these factors appears under the heading Cautionary Note Regarding Forward Looking Statements in the slide deck we issued this morning and under the heading Risk Factors in our most recent Form 10 ks and subsequent Form 10 Qs filed with the Securities and Exchange Commission available at www.sec.gov and on our website at novavax.com. The forward looking statements in this presentation speak only as of the original date

Operator

of this

Speaker 1

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 a non GAAP financial measure, which is forward looking information for R and D and SG and A expense as adjusted for expense reimbursement from Sanofi under the Sanofi agreement. 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 4 key value drivers.

Speaker 1

Additionally, John Trizzino, our President and Chief Operating Officer, will provide an update on our operating activities and Doctor. Bob Walker, Chief Medical Officer and Interim Head of Research and Development, will discuss our clinical development and pipeline. Finally, Jim Kelly, our Chief Financial Officer and Treasurer will provide an overview of our financial results and implications of the Sanofi partnership. I would now like to hand over the call to John Jacobs.

Speaker 2

Thank you, Erica, and thank you, everyone, for joining us. I'm pleased to be with you today along with the members of our executive team to highlight our recent achievements, progress on our annual priorities and the shaping of a new vision for Novavax. When we spoke with you last quarter, we were taking the first steps on this exciting journey with the announcement of our global partnership with Sanofi. Our collaboration with Sanofi has allowed us to monetize the value of our COVID-nineteen vaccine and proven technology platform and frees up resources to develop multiple opportunities in the vaccine space. Since then, we have worked hard to execute on our and are beginning to position the company back toward its roots as an innovation driven organization, while remaining a close commercial partner to Sanofi for our COVID-nineteen vaccine.

Speaker 2

We are beginning to evolve from a company that is independently manufacturing, distributing and commercializing vaccines on a global scale to a much more efficient and focused R and D model. This means that we intend to drive future value from additional business development activities and organic R and D via our proven and validated technology platform, with plans to unveil a new and expanded clinical pipeline by the end of this year and to seek to execute our plans within a much leaner operating model in 2025 and beyond. The potential value drivers of our business are outlined on Slide 5 and include: Value Driver 1, the Sanofi Partnership Value Driver 2, late stage pipeline value driver 3, leveraging our proven technology platform to drive additional partnerships and deals and value driver 4, a new early stage pipeline. It is our intention that these potential value drivers will be supported by an appropriately scaled infrastructure with significantly reduced expenses versus our 2020 4 baseline. Jim Kelly will provide more detail and clarity on our expense projections later on in the call.

Speaker 2

So let's take a moment to expand on each of these potential value drivers that are intended to be the foundation of our new growth strategy for Novavax. Value driver 1, the Sanofi Partnership. The Sanofi Partnership has 4 potential areas of value. First, immediate upfront payment and equity investment of approximately $570,000,000 Next, midterm milestones related to our partnered COVID-nineteen vaccine of approximately $350,000,000 and Sanofi's independent flu COVID-nineteen combination program were another $350,000,000 3rd, anticipated royalty streams from both of these programs and 4th, long term royalties and or our Matrix M adjuvant. That means, for example, any additional combination vaccine commercialized using our COVID vaccine is eligible for royalties.

Speaker 2

Also, any new vaccine developed using our Matrix M adjuvant is eligible for both milestones and royalties. That being said, the partnership structure offers potential opportunities for decades to come. And because Sanofi is a global leader in vaccine development and commercialization with a substantial presence and proven track record in seasonal respiratory vaccines in the U. S. And around the world, We have the utmost confidence in their ability to perform when they begin commercializing our COVID-nineteen vaccine next year and potentially launch multiple additional vaccines using our technology in the future.

Speaker 2

We look forward to providing further updates on our partnership at the appropriate time. Value driver 2, Novavax late stage pipeline. As we have stated on prior calls, we are on track to independently initiate our own late stage Phase 3 trial in the Q4 of this year to evaluate our standalone influenza and COVID-nineteen influenza combination vaccines. Top line data from this trial is expected by the middle of 2025. These assets have already demonstrated promising Phase 2 data.

Speaker 2

We intend to partner or monetize these assets assuming successful Phase 3 results rather than commercialize them ourselves, which should allow us to avoid significant infrastructure expense and execution risk. Moving on to value driver 3, leveraging our proven technology platform to drive additional partnerships and deals. Beyond the 2 late stage assets, our proven technology platform has the potential to offer other companies significant value And our ambition is to be a partner of choice to help others enhance or even expand some of the established in line vaccine franchises of larger players. For example, we believe that Matrix M can help enhance many existing vaccines in the portfolios of other companies by boosting immunogenicity and lowering COGS without adding to the side effects burden. Later in this call, Bob Walker will share some new data with you as an example of this capability.

Speaker 2

These MatrixM attributes may also enable companies with clinical stage vaccine portfolios to make those vaccines more competitive as they strive for the best product profile and even allow for the creation of new vaccines that might not have otherwise been possible. We continue to explore the potential of our technology and believe that we have only just begun to tap into the value of our platform to our company and portfolio and to that of other vaccine companies. And finally, value driver 4, new early stage pipeline. Our final and 4th potential value driver is the development of our own early stage organic pipeline. Rather than focus our efforts on seasonal commercial execution of a single vaccine asset, we will instead invest our time, energy and capital on the development of an expanded pipeline that uses our recombinant nanoparticle technology platform to develop new assets focused on infectious disease and respiratory as well as potentially vaccines in other disease or areas and categories.

Speaker 2

We will be looking to develop assets that we believe can make a significant difference for global public health and at the same time present a significant commercial opportunity. We reserve the right to develop launch and commercialize any of these assets ourselves should the emerging data and business case support it. For the remainder of 2024 and in line with our key value drivers, we will continue to execute on our 4 priorities, which you should be seeing on Slide 6. And these priorities are: priority 1, the successful execution of our new partnership with Sanofi priority 2, driving incremental value from our technology and pursuing new business development opportunities. And pursuing new business development opportunities.

Speaker 2

Priority 3, continue to reduce our R and D and SG and A costs in line with our prior stated targets and prepare for additional significant reductions to scale and cost as we enter 2025 and beyond. And finally, priority 4, delivering our updated COVID-nineteen vaccine for the 2024, 2025 fall vaccination season. As we enter the second half of this year, we look forward to sharing more details on our updated plans as we continue to forge a new path forward. Now I would like to hand it over to the team to discuss our results from the quarter in more detail, beginning with John Trizzino for our operating updates. John?

Speaker 3

Thank you, John. Q2 was another quarter of progress for the business as we continue to lay the groundwork for a successful nevaximod co commercialization effort with Sanofi beginning in 2025. And with the 2024, 2025 season start less than 1 month away, we have continued to lay the groundwork for success by updating and filing for authorization of our updated COVID-nineteen vaccine formulation. Please turn to slide 8. In the U.

Speaker 3

S, as John mentioned, we are concentrating our commercial efforts for the remainder of the year on our largest market, the U. S. This should enable us to drive continued cost savings starting this season and continuing into 2025 and beyond as we wind down our independent commercial presence in markets around the world in anticipation of Sanofi taking the lead on commercialization of our COVID-nineteen vaccine starting in 2025. Turn to slide 9. For the first time, we expect our product to be available in a prefilled syringe in the U.

Speaker 3

S. The product will be arriving in the U. S. This month and will be held in our warehouse as we await authorization before we can begin distribution. Turn next to slide 10.

Speaker 3

We have adopted a highly targeted commercial approach and will focus on the retail pharmacy channel, where over 90% of administrations occurred last season. We have secured contracts with CVS Pharmacy, Rite Aid, Walgreens, Costco as well as regional grocers and independent pharmacies and thus are tracking towards a significantly increased availability compared to last year. We have already initiated pre season marketing efforts to build upon last year's campaign to drive increased awareness of NuVaxitin. Please turn to slide 11. In Europe, given our upcoming transition of primary commercial responsibilities to Sanofi, we plan to conduct a lean, limited and targeted commercial launch in the region while still maintaining the necessary operations to ensure Sanofi is well positioned in Europe to execute beginning in 2025.

Speaker 3

This means we are focused on delivery of our updated vaccine in select European markets including Germany, Italy and Poland. We are already actively engaged in planning and partnership execution activities in the U. S. And Europe with the goal of creating a springboard for long term value creation via enhanced Sanofi commercial sales of NuvaXivud, while at the same time streamlining our own commercial execution for the upcoming season. The APA contracts we have been managing since the pandemic played an important role over the past few years in helping to manage vaccine distribution and access for millions of potential consumers around the world.

Speaker 3

As the pandemic has moved to annual seasonal vaccination and vaccination rates around the world for COVID have dropped. We are working with our government customers to renegotiate, adjust or where appropriate exit these agreements while preserving as much of their value as possible. To recap, we remain intently focused on and are well on track for a more successful U. S. Vaccination season than we experienced last year.

Speaker 3

With anticipated FDA authorization of our 2,425 formulation ahead of the fall campaign, manufacturing underway of our competitive pre filled syringe presentation, continued traction in driving retail availability and increased product awareness, we have all the components necessary for a better performance this 202425 U. S. Vaccination season launch, which we are confident will serve as a foundation for continued new vaccinate uptake in 2025 and beyond under Sanofi. Now I want to turn the call over to Bob to discuss our research and development updates.

Speaker 4

Please turn to Slide 13. Thank you, John. I'm going to present key updates and highlights from our research and development activities from the last quarter, which support the 4 key value drivers John outlined earlier. I'll discuss the 2,000 four-twenty five COVID-nineteen strain change, our kick and influenza programs, our efforts to expand potential opportunities for Matrix M and our internal preclinical pipeline. Please turn to Slide 14.

Speaker 4

With regard to our COVID-nineteen vaccine and the 24, 25 strain change, we were pleased that the CDC renewed their recommendation for universal vaccination for everyone 6 months and older for the upcoming season with the updated vaccine and did not differentiate among manufacturers or vaccine strains. Our updated vaccine, which uses the JN1 strain, often characterized as the trunk of the tree from which the currently circulating variants emerged, is well positioned to compete with the mRNA vaccines this fall in light of the guidance issued by the leading regulatory and policy bodies. We submitted our regulatory packages for the strain change to both FDA and EMA in June, And we continue to work with the regulators to facilitate a smooth review and approval in the effort to our vaccine available early in the vaccination season. And as you've already heard from John, our updated vaccine is on track to be in warehouses this month and is expected to be ready for distribution upon authorization. Please turn to Slide 15.

Speaker 4

We continue to monitor the performance of our JN1 vaccine against new variants in non clinical studies. Our data indicate that our vaccine targeting JN1 should provide acceptable coverage for the currently circulating variants. This slide shows neutralizing antibody responses with JN1 vaccine in rhesus macaques. You can see that the antibody titers are robust across the spectrum of variants. And this includes the KP3 and KP3.1.1 variants that are now widely circulating.

Speaker 4

Using these data, when we look at antigenic distance among these variants shown in the table to the right, we see that in all cases, the antigenic distances are below 2.0 antigenic units, indicating that the variants are all antigenically similar to JN1. And that has been the consistent observation since we've started this monitoring, which we intend to continue to do for each newly prevalent variant throughout the season. So as you can see, our data indicate that our vaccine targeting JN1 should provide acceptable coverage for the currently circulating variants. Please move to Slide 16. As John outlined, our second value driver is our late stage pipeline, which has the potential to deliver vaccine candidates.

Speaker 4

Our Phase 3 immunogenicity trial for our standalone influenza and kick vaccines remains on track to start in the Q4 of this year with top line data expected by the middle of 2025. We have alignment with FDA on the use of a single Phase 3 immunogenicity study for both KIK and influenza programs and are still in dialogue with them on the feasibility of the accelerated approval pathway for both products. We look forward to bringing you additional updates as we continue to advance these programs. Potential timeline and pathway to registration will be dependent upon full alignment with FDA and the results of the trial. As a reminder, data from our Phase 2 study demonstrated that our KIK vaccine induced anti influenza neutralizing antibody levels in the top three plots, HAI antibody levels in the bottom three plots and anti spike neutralizing antibodies bottom left that were generally comparable if not higher than levels achieved after either of the comparator vaccines.

Speaker 4

We believe these results give us more confidence in the program and in the feasibility of an accelerated approval pathway for either or both vaccines depending on final data readout. In preparing to move into Phase 3, we have received FDA concurrence on the conduct of a single Phase 3 immunogenicity study for both kick and standalone influenza vaccines. The trial will be conducted in older adults in the Southern Hemisphere in Australia and New Zealand during the off season. The FDA recommendations we have received during the pre IND process are being incorporated into the trial. And we expect that with an anticipated 4th quarter start, we should have top line data by the middle of 2025 to enable internal decision making and potential partnering.

Speaker 4

Please turn to Slide 18. Now I'd like to turn our attention to our proven tech platform, our 3rd value driver, and to recent preclinical work aimed at expanding the utility of Matrix M, our saponin based adjuvant. Because we know that Matrix M is a potent adjuvant for our nanoparticle viral vaccines, we decided to investigate whether Matrix could boost immune responses in other vaccines, such as in inactivated influenza split virus vaccine already licensed. The results I'll show you indicate that Matrix M increases the magnitude and breadth of antibody responses when given with a licensed egg based influenza vaccine with the potential to produce a more potent, more highly protective vaccine. In the figure on the left, our AG HAI responses in mice vaccinated with a licensed inactivated quadrivalent influenza vaccine in the left four bars and in mice vaccinated with the same vaccine plus matrix in the right four bars.

Speaker 4

Responses to all 4 influenza strains are boosted in the vaccine plus matrix group. In the figure to the right, competition binning experiments against a panel of monoclonal antibodies demonstrate that matrix induced antibodies directed to conserved epitopes in the resulting in broader cross reactive responses. These data demonstrate one of the most important attributes of Matrix, its ability to increase the magnitude and breadth of antibody responses with the potential to produce a more potent, more highly protective vaccine. Please turn to Slide 19. But what about the potential for Matrix M to enhance the activity of non protein and non viral vaccines?

Speaker 4

Bacterial capsular polysaccharides are known to be poorly immunogenic vaccine antigens, especially in infants and young children. And we wanted to explore whether the benefits of Matrix could be extended to bacterial vaccines. In this experiment, mice were vaccinated with a pneumococcal vaccine either with or without matrix added and anti pneumococcal IgG antibody titers were increased over eightfold in mice that received vaccine plus matrix. A similar adjuvant effect was observed when looking at functional antibodies that mediate subtype specific killing or OPK, a known correlate. OPK responses were increased 2.6 to 7.5 fold in mice that received vaccine with matrix for the 4 subtypes shown on the right.

Speaker 4

And notably, the subtype with especially low immunogenicity, subtype 23F at the bottom right, showed the greatest increase 7.5 fold with the addition of Matrix. These preliminary data I've shown you suggest that Matrix could play an important role in augmenting certain currently available vaccines such as influenza and pneumococcal vaccines by increasing the quality and duration of immunity, reducing the amount of antigen needed per dose and lowering manufacturing costs. Our data also suggests that which we regard as an exciting area for more research. Which we regard as an exciting area for more research. We believe that these matrix attributes could be attractive to partners with established vaccine franchises.

Speaker 4

Please turn to Slide 20. Finally, I want to discuss our new early stage pipeline, which is our 4th value driver. As you heard, we are in the middle of a strategic assessment of our technology platform to determine how to best expand and refresh a new full product pipeline for Novavax, and we are excited about the new initiatives that may spring from that review. As we work to complete this analysis, in parallel, we have continued to advance our RSV and avian influenza H5N1 preclinical vaccine candidates and continue to prepare both to move into the clinic. At our last earnings call, we shared the animal model results on this slide.

Speaker 4

On the left are data showing that our RSV nanoparticle vaccine with matrix was more immunogenic for both A and B subgroups than a comparator RSV vaccine with AS01E adjuvant. We believe our RSV candidate, though still early in development, has the potential to be 1st in class for both safety because of Matrix M and effectiveness. The data on the right are for our H5N1 vaccine, showing that a single boost by injection was highly immunogenic in non human primates previously primed with a seasonal influenza vaccine. And even a single intranasal boost in red showed responses above the commonly accepted threshold for protection of 1 to 40. An effective one dose regimen for a pandemic influenza vaccine would provide a paradigm shift in public health and pandemic preparedness by providing more rapid protection and the potential to save many more lives than the current stockpiled 2 dose regimens.

Speaker 4

We plan to start IND enabling studies for both vaccines as soon as next month to support the start of Phase 1 clinical trials. And you will hear more from us later this year about additional areas of development for our technology. Now to discuss our financials for the quarter, I want to hand the call to Jim.

Speaker 5

Thank you, Bob. Please turn to Slide 22. We're focused on improving the financial health and performance of Novavax to enable long term value creation. Today, we outlined more detailed plans to deliver on this vision. To begin, I'll share a few of the key themes for the Q2 of 2024 and look towards full year 2024 and beyond.

Speaker 5

For the Q2 of 2024, Novavax recorded total revenue of $415,000,000 consisting primarily of $391,000,000 from the GAAP revenue recognition for the $500,000,000 upfront payment from Sanofi received fully in the Q2. The remaining $119,000,000 from the upfront milestone payment will be allocated over the transition services period through 2026. We estimate full year revenue recognition for this upfront payment to be approximately $400,000,000 for 20.24 and the remaining $100,000,000 evenly split across 20252026. We have incorporated this GAAP revenue recognition into our full year 2024 guidance. As we continue to transform Novavax into a more lean and agile organization, we reduced our Q2 2024 combined R and D and SG and A by 34% compared to prior year.

Speaker 5

When excluding Sanofi transaction costs for the period, we saw a decrease of 43%. As we look forward to the full year 2024, we are reiterating our targeted guidance for combined R and D and SG and A expenses of between $700,000,000 $750,000,000 as we continue to resize our organization. Novavax is prepared to initiate an additional cost reduction program to further reduce combined R and D and SG and A expenses, a portion of which we expect to be reimbursed by Sanofi under the agreement. For 2025 and net of reimbursement, we're targeting non GAAP combined R and D and SG and A of below 450,000,000 dollars We ended the Q2 of 2024 with cash and accounts receivable of approximately 1,100,000,000 dollars We believe the Sanofi agreement provides for a multi $1,000,000,000 cash flow over time. During the Q2 of 2024, received approximately $570,000,000 in cash payments that further improved our financial position.

Speaker 5

Importantly, we are prioritizing the completion of our APAs, enabling a reduction to Novavax commercial operating activities and complexity as a means to further reduce our costs. Please turn to Slide 23 for a more detailed review of our Q2 2024 results. For the Q2 of 2024, we recorded total revenue of $415,000,000 compared to $424,000,000 in the same period in 2023. Our product sales of $20,000,000 in the Q2 of 2024 were primarily related to the expiration of certain EPA purchase rights. Our cost of sales for the Q2 of 2024 were $46,000,000 as compared to $56,000,000 for the same period in 2023.

Speaker 5

These periods include $24,000,000 $31,000,000 respectively related to excess obsolete and expired inventory, losses on firm purchase commitments and unutilized manufacturing capacity. As previously noted for the Q2 of 2024, Novavax's combined R and D and SG and A of $208,000,000 reflects a 34% reduction from the same period in 2023. Excluding the $31,000,000 in Sanofi transaction costs, our Q2 2024 combined R and D and SG and A was approximately flat to the Q1 of 2024. Please turn to Slide 24. The Sanofi agreement provides for a multibillion dollar potential across upfront equity investments, milestones and royalties.

Speaker 5

The anticipated present value of the royalties on Sanofi's nevaxavid, flu COVID and combination products and new vaccines with MatrixM are expected to be the largest individual component of value from this transaction. Of note, this agreement reflects just one of the 4 pillars of value for Novavax and given its many layers, it's worth another review to be better appreciated. Please turn to Slide 25. The COVID-nineteen and Sanofi COVID flu combination related terms include the potential for up to approximately $1,300,000,000 in one time milestone cash payments and equity investment. During the Q2 of 2024, the initial cash payment included $500,000,000 upfront and approximately $70,000,000 equity investment in Novavax stock.

Speaker 5

Near term Novavaxovid COVID-nineteen milestones of 350,000,000 dollars and COVID flu combination milestones of $350,000,000 should provide important cash flow to the company. We expect to complete database lock in the Q4 of 2024, which would enable earning the first $50,000,000 milestone. Revenue recognition for this milestone will be allocated over the transition services period through 2026. All other milestones under the agreement will be recognized in the period when earned. The $175,000,000 BLA milestone is anticipated to align to our BLA PDUFA date and The $225,000,000 BLA milestone is anticipated to align to our BLA PDUFA date and approval, which is presently targeted for April 2025.

Speaker 5

The $225,000,000 authorization transfer milestones are expected to follow as we enable Sanofi to commercialize Novaxovid in the U. S. And Europe for the 2025, 2026 vaccination season. The $75,000,000 technology transfer milestone is expected to follow completion of our transition services obligations that we currently estimate to occur in late 2026. For the Sanofi Flu COVID program, there are 2 milestones totaling 350,000,000 dollars related to the development and first commercial sale.

Speaker 5

Sonofi recently noted on their earnings call that they expect to start clinical trial manufacturing activities in 2024. We are working to support Sanofi in these efforts and await more visibility into the potential timelines. In addition, Novavax is eligible to receive tiered royalties on net sales from COVID-nineteen mono and COVID combination products. This enables Novavax meaningful participation in future economics from the current and future products under this agreement. New vaccines developed with MatrixN by Sanofi create a broad opportunity to advance this technology and provide Novavax with multiple revenue generation opportunities.

Speaker 5

We are eligible to receive up to $210,000,000 in milestones plus ongoing royalties for 2 decades from the time of launch for each new vaccine developed utilizing Novavax's MatrixM adjuvant. For example, if Sanofi developed 5 products with our Matrix M, each with $1,000,000,000 in sales, This represents 100 of 1,000,000 in royalties per year plus over $1,000,000,000 in one time milestones. Novavax will support Sanofi as it prepares to advance all programs associated with this agreement and Novavax will be eligible for cost reimbursement across the host of spend categories. Please turn to Slide 26. We're committed to creating a more lean and agile organization to align the company with the company's market opportunities.

Speaker 5

To advance that goal for 2024, we are reiterating our targeted combined R and D and SG and A expense guidance of $700,000,000 to $750,000,000 We are currently at the high end of the range when accounting for the Sanofi transaction costs and we will continue to push to find savings in our cost structure as the year progresses. Novavax is prepared to initiate an additional cost reduction program to reduce combined R and D plus SG and A expenses, a portion of which we expect to be reimbursed by Sanofi under the agreement during 20252026. For 2025 and net of expected reimbursement, we expect our non GAAP combined R and D and SG and A to be below $450,000,000 By 2026, we expect to drive down combined R and D and G and A expenses to below $350,000,000 In addition, as we assume a secondary role in commercial markets, this enables the reduction of commercial and supply chain costs. We are actively exploring the sale of our Czech Republic manufacturing facility, which could both provide cash proceeds and reduction to our ongoing operating costs. Please turn to Slide 27.

Speaker 5

Now turning to financial guidance that we have updated to incorporate the GAAP revenue recognition for the $500,000,000 Sanofi upfront payment and outlook for APA and commercial sales. Of note, we received the full upfront payment of $500,000,000 approximately $70,000,000 equity investment from Sanofi during the Q2 of 2024. For the full year 2024 and on a GAAP basis, we expect to achieve total revenue of between $700,000,000 $800,000,000 This includes $400,000,000 of revenue recognition from the $500,000,000 Santa Fe agreement upfront payment and $25,000,000 in royalty and other revenue partner related activities, which is recorded as licensing, royalty and other revenue. We are updating our full year 2024 product sales guidance and expect to achieve between $275,000,000 $375,000,000 This includes $100,000,000 for the APAs already delivered through mid year and commercial product market sales of $175,000,000 to $275,000,000 in the second half of twenty twenty four. Importantly, our expectations for the U.

Speaker 5

S. Market performance remain unchanged and we expect the majority of remaining product sales to occur in the Q4 of 2024. The $150,000,000 reduction to the midpoint of our full year 2024 product sales guidance reflects $100,000,000 from the New Zealand APA. We are in ongoing discussions with New Zealand in response to their desire to cancel this agreement and $50,000,000 from EU commercial sales as we target a smaller set of prioritized countries for the 2024, 2025 vaccination season. For the remaining APA agreements, our intent is to amicably negotiate or deliver doses or when appropriate exit agreements with the goal of these activities to be cash flow neutral or favorable on a go forward basis.

Speaker 5

To be conservative, we're removing APA sales from our forward looking revenue expectations until further clarity is available on each. We'll instead emphasize realization of cost savings that come from exiting commercial markets. Our current operating plan, including the multiyear combined R and D and SG and A expense targets highlights a path to maintaining our goal of at least 1 to 2 years of cash on hand prior to receipt of cash flows from the Sanofi agreement in the form of milestones and royalties. We look forward to sharing additional updates as we seek to 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.

Speaker 2

Thank you, Jim. Before we take your questions, I'd like to thank you all for joining us today and for your ongoing support as we work to build a new vision and future growth platform for Novavax. As you have heard, we're working hard to position the company for future growth with a focus on our new value drivers, including Driver 1, the Sanofi Partnership, which provides for a multibillion dollar potential across upfronts, equity investment, milestones and royalties over time Value Driver 2, our late stage pipeline value driver 3, leveraging our proven tech platform to drive additional partnerships and deals and finally, value driver 4, our new early stage pipeline. I'd now like to turn the call over to our operator for questions and answers. Thank you.

Operator

Thank you. We will now begin the question and answer session. We now have our first question and this comes from the line of Roger Song from Jefferies. Please go ahead.

Speaker 6

Great. Congrats for all the progress and thank you for taking our questions.

Speaker 2

Thank you, Roger.

Speaker 6

Yes. Thank you, John. So the first one is regarding the updated 2024 guidance. Understanding nothing really changed for the U. S.

Speaker 6

Expectation mostly driven by the EU and New Zealand. Just curious about the can you give us some of the updates regarding the U. S. Contracting, given this timing of the season, how confident you are, you will be able to deliver this guidance in the U. S.

Speaker 6

Particularly? Thank you.

Speaker 2

Good question, Roger. John T, you want to take that one?

Speaker 3

Yes, sure.

Speaker 2

Operator, can you hear us okay?

Speaker 3

Is that better, Roger?

Operator

Yes, sir. Your line is open.

Speaker 3

Okay. So we had a bit of a technical difficulty there for a moment. So maybe let's maybe back up in to address Roger's question. So as far as retail pharmacy contracting, execution so far has gone extraordinarily well. As you can see from the slide that we presented, all of the top retail pharmacies are under contract, as well as many of the buying groups for the smaller grocers and independents.

Speaker 3

We've made great progress over last year with things like online schedulers and access and stocking orders that will be in each of those. So much better progress from last year. I think that will provide an opportunity for those interested in getting the vaccine to come into the pharmacy. Some of our communication programs at the consumer level and then also at the pharmacist level will open that door to availability to the product. So I think all that's gone in a very positive direction.

Speaker 6

Excellent. Thank you. Thank you.

Operator

Thank you. We will now take the next question. And this comes from the line of Amayank Mamtani from B. Riley Securities. Please go ahead.

Speaker 7

Congrats on many components of your portfolio showing progress today. About your CIG Phase 3 study, maybe if you could learn some protocol differences that you have integrated in your program having the advantage of going 3rd here. So if you could maybe highlight that. And then why do both the flu vaccine and the combination vaccine in the same study versus maybe trying to do separately is the other question because there are control arm differences and you obviously have pretty strong compelling data on strain B from the previous NanoFlu candidate. So if you could maybe help clarify your strategy here, it would be helpful.

Speaker 7

And then I have a follow-up.

Speaker 2

So Mayank, thank you for your questions. Bob, two questions from Mayank. The is have we made any changes to the protocol based on what we've learned, the fact that we're going 3rd here? And then secondly, his question about 1 program versus 2, if you want to handle that one. Thank you.

Speaker 4

Sure. Thanks for that. So we do have, as I mentioned earlier, we do have alignment with FDA on conducting a single Phase 3 protocol to support both products. And we are in we remain in dialogue with them on some of the details. So I don't think we're prepared to actually discuss the specifics of the protocol design at this time.

Speaker 4

But let's say to answer your second question, study by using shared comparator control groups. And we also do know that the previous experience that you allude to with the influenza vaccine can also be leveraged to support the safety database for the product for the new product.

Speaker 7

Okay. Got it. And then just on the long term OpEx guidance that you put out there, given that there are some interesting parts of your earlier stage pipeline that you'd look to also advance and you talked to some of that. Could you just give us a little bit of a mix of R and D, SG and A? And also when should we start to see some of these candidates get into the clinic from either you or even your partner Sanofi?

Speaker 7

And thanks again for taking our questions.

Speaker 2

Good question, Mayank. Jim Kelly will address the financial question.

Speaker 5

Exactly. Mayank, you're right on spot in terms of capturing the dynamic of our cost structure change while we strategically enable really the unlocking of significant value from our early stage pipeline. We expect the vast majority and the majority of our cost structure as we approach that 2026 below $350,000,000 to be invested back in this value creating early stage pipeline as we continue to drive to a lean and agile organization.

Speaker 2

And then Mike, I believe the second part of your question was when do we expect to see some new assets emerge in our pipeline and what timing might that be regarding hitting the clinic. So I think we're excited to unveil what that new pipeline is by the end of the year. As you know we're also deep into a search for our new President of Research and Development. We've had a lot of interest in Novavax especially post the Sanofi deal with further validation of our Matrix M and proven technology platform. The fact that around the world people are recognizing what this technology is capable of and I hope everyone was able to hear some of the examples that Bob Walker shared where we've added Matrix M to other products that are established and in market right now that are significant franchises for other companies.

Speaker 2

We've shown an ability to potentially improve those products and even reduce their cost of production. These are significant and we believe our technology we've only just begun to tap into that potential. So we're very excited to unveil what our exploration of that technology right now might be telling us on what else we can do beyond a seasonal vaccine, beyond even respiratory potentially. We know that's where our wheelhouse is right now, but this technology has capabilities well beyond what we've explored with it so far. So as we get to that unveiling, we will be sharing also mining some timelines on that And we look forward to doing that in the future when we have more context.

Speaker 2

Importantly, we're deep into the analysis and exploration of what else we could do with the tech and post Sanofi and post the last 18 months of lifting our going concern, putting the Gavi situation behind us, reducing our current liabilities significantly, improving our balance sheet, improving our cash position. We've now put Novavax in the position to focus more on what we do best, which is research and development from this amazing technology platform. So we're excited to share that with you in the future. We're working diligently on transitioning the company away from focusing all of our energy on one product every season to now being able to focus on multiple shots on goal for potential future growth, which we laid out as our 4 drivers. We're in that transition now and it's a period that we ask for a little bit of patience as we wrap up our last season and we change of the company toward this.

Speaker 2

We're excited about what the future holds and we're excited to unveil that pipeline in the coming quarters.

Speaker 7

That's helpful. Look forward to learning more details on that. Thanks again.

Operator

Thank you. And the next question comes from Bank of America. Please go ahead.

Speaker 8

Hey guys. Thanks for taking our questions. Just a couple from me. One follow-up just on the KICK program. Is your expectation that there could be an approved KICK therapy in the U.

Speaker 8

S. Given you've shifted your Phase 3 enrollment to Australia and New Zealand? And then just curious since the PDUFA for the BLA will be after handing the reins over to Sanofi, whether they had any input into the filing or if any of the terms under the collaboration are contingent upon receiving the BLA? Thanks.

Speaker 2

Alec, great to hear from you. Thank you for your questions. I think the first question, we just want to make sure we understand your question correctly. If I heard you clearly, you were asking is there the chance for a U. S.

Speaker 2

Approval since the recruitment is occurring in Australia. So I'll hand that over to Doctor. Bob Walker. Go ahead,

Speaker 4

Bob. Right. So, the study is our plan is to conduct the study in the Southern Hemisphere, Australia, New Zealand as mentioned. The study would be done under U. S.

Speaker 4

IND, so those data would apply to a U. S. Application.

Speaker 2

And I believe, Alec, your second question related to the timing of BLA and the related milestone with Sanofi and the timing of handoff of commercialization. Just to clarify, if you might clarify that, are you seeking to understand timing of the potential receipt of that milestone payment that would be associated with that?

Speaker 8

Yes. I guess I was asking more in terms of input from Sunofi on the BLA and whether there's anything contingent, milestones or otherwise on that BLA? Thank you.

Speaker 2

Well, obviously, we're working very closely with our partner Sanofi and very excited about that partnership and what it could mean in the future. But we have already filed that BLA and that's already under review by FDA.

Speaker 3

Yes. Just to add to that a little bit, there's ongoing and constant interaction with Sanofi on all of these necessary steps. The BLA importantly, one for the sake of the milestone, but also as we move forward and look at each and every next season, the preparation for the season having the BLA in place is an important next step for us. And so, yes, there's a significant coordination between our organizations to make sure that we have the value of their inputs and that we're moving forward as quickly as we can.

Speaker 8

Makes sense. Thanks for the color.

Operator

Thank you. And this comes from the line of Eric Joseph from JPMorgan. Please go ahead.

Speaker 8

Hi, good morning. Thanks for taking the questions. Just on first on commercial, just with your U. S. Sales guidance here, can you just talk about sort of what that anticipates in terms of dose volume you expect to go into market with and how you should think about sort of gross margins for the COVID vaccine for your COVID vaccine moving to a PFS format?

Speaker 8

And then secondly, for the Phase 3 study starting later this year, maybe just sort of by way of backing into the design of that trial. Can you talk a little bit about sort of what activity profile or yes, comparative activity profile you'd like to be in market with or hope to be in market with with a standalone flu vaccine? Thanks.

Speaker 2

Erica, we'll hand the first question over to John Trazino. I don't believe, John, we're disclosing specifics of dose volumes, etcetera, for competitive reasons, but you may want to take an attempt at Eric's first question.

Speaker 3

Yes. No, I what's important to talk about here is our readiness for the season. The guidance is one thing, but our ability to accomplish what we think is aligned with that guidance has multiple factors. Focus on the pharmacy one, which we've talked about, which is significantly important. Also what pricing strategy is and we're not going to get into disclosing what our kind of discounting strategy is on this call.

Speaker 3

But all pulled together to make us well positioned. Availability of product near the end of the month and certainly at the start of the season, making sure that the contracts are in place, that we're well positioned from a discounting strategy to support access into the product and then availability throughout the whole season. So I think that's kind of the most important takeaway.

Speaker 2

Thank you, John. And then Eric, your second question, if we understood you correctly, you were asking about, I believe, what type of profile we're seeking or hoping to have out of our clinical program that could make our product competitive against others. Bob, did you want to address that?

Speaker 4

Well, I'll say that for the purposes of the Phase 3 trial, The statistical test will be that the combination product performs in a non inferior way immunologically to each of the individual components. So to kick to the influenza component and kick to the COVID component. So that would be the immunologic test. And the value of the product I think is the fact that it's a combination. The design is enables a hierarchical statistical analysis that can also evaluate superiority.

Speaker 4

So that's built into the design. And so we'll be able to make conclusions on both of those points.

Speaker 2

But Thank you, Bob. That was helpful on the design of the study and potential data points we could assess afterwards. Jon T, any commentary on target product profile?

Speaker 3

Commercial viability here is critically important, right. As we look at the viability of our CIC program, primary focus of the trial, we also took the opportunity to look at standalone flu, right. So standalone flu continues to be an important product and public health vaccine profile. But we also believe we've got a very strong candidate that could demonstrate improved efficacy in the market. We also want to establish a seasonal influenza vaccine as a foundation for possible pandemic.

Speaker 3

In the future, H5N1 continues to be important and isn't being observed around the globe. So having the opportunity to have data coming out of our standalone flu vaccine, knowing what some of those other dynamics are and knowing the profile of our flu vaccine and the significant improvements over existing flu vaccines, I think position us well for future value creation.

Speaker 2

Thank you, Bob and John. And Eric, one last comment there is that certainly we believe that our technology can afford the development of vaccines with a very good tolerability profile. And as the market moves toward combination, which our research indicates it should, with multiple seasonal diseases out there that people are trying to protect themselves against that having a product where you can combine multiple antigens in with a very nice tolerability profile potentially versus competitors is very important in the marketplace for consumers as they make a decision on which combination vaccine they may want. So again, when we get the data, we'll assess the data, we'll steer the strategy and tell us how competitive it is. But we have confidence in our tech platform that it has a good chance to really produce a nice profile that will be competitive.

Speaker 2

Thank you.

Operator

Thank you. And we don't have any further questions at this time. Oh, sorry, we have oh, yeah, no further questions at this time. This concludes our Q and A session as of the moment. Over to your speaker, John Jacobs, for any closing remarks.

Operator

Please go ahead, sir.

Speaker 2

Thank you, operator. Appreciate it. And thank you, everyone, to join us today. We appreciate your support. We appreciate your patience as we work through the future strategy for Novavax and start to deliver opportunities for long term growth in 4 different categories that we highlighted today.

Speaker 2

We're excited about what the future holds as we continue to reduce our cost basis, move toward a more lean operating structure and prepare for the next chapter in the company's history. Thank you so much for joining us everyone.

Operator

Thank you. This concludes our conference for today. Thank you for your attendance. You may now disconnect.

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Earnings Conference Call
Novavax Q2 2024
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