Novavax Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2023

Key Takeaways

  • Novavax is on track to deliver its updated XBB.1.5 COVID‐19 vaccine at commercial scale for the fall 2023 season, having initiated U.S. filings and secured ample supply for key markets.
  • The company ended Q2 with over $900 million in cash and receivables, reduced current liabilities by more than $1 billion year-to-date, and secured an $85 million equity investment from SK Bioscience at a 59% premium.
  • Cost‐reduction efforts are on track, with Q2 R&D and SG&A expenses down 21% year-over-year and full-year 2023 targets maintained at $1.3–$1.4 billion; 2024 targets aim for below $1 billion.
  • Novavax is advancing its pipeline by investing in a COVID–influenza combination vaccine, progressing pediatric and high-dose COVID programs, and leveraging its Matrix M adjuvant through collaborations in malaria and Gates Institute projects.
  • Despite progress, the company faces execution risk around timely regulatory approvals, successful market uptake in a newly commercial U.S. model, and evolving COVID‐19 demand this fall.
AI Generated. May Contain Errors.
Earnings Conference Call
Novavax Q2 2023
00:00 / 00:00

There are 12 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Second Quarter 2023 Financial Results and Operational Highlights Conference Call. At this time, all participant lines are in a listen only mode. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Erica Schultz. You may begin.

Speaker 1

Good morning, and thank you all for joining us today to discuss our Q2 2023 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 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, operating plans, objectives and prospects, Full year 2023 financial guidance, its future financial or business performance conditions or strategies, Its partnership anticipated timing and outcome of future regulatory filings and actions and the ongoing development of its Our manufacturing capacity and the future availability of our vaccine candidates and key upcoming milestones. Each forward looking 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 Q filed with the Securities and Exchange Commission and available at www.sec.gov on our website atnovavax.com as well as subsequent filings with the SEC.

Speaker 1

The forward looking statements in this presentation Speak 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 a non GAAP financial measure, which is forward looking information for R and D and SG and A expenses as adjusted to exclude onetime restructuring costs as described on this slide. 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 for the 3 key priorities.

Speaker 1

Additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer will provide an update on our commercial activities and Doctor. Philip Dibalski, President of Research and Development will discuss our COVID clinical development and pipeline. Finally, Jim Kelly, Chief Financial Officer and Treasurer will provide an overview of our financial results. Rick Crowley, Chief Operations Officer, will be also available for the Q and A section at the end of today's call. I would now like to hand over the call to John Jacobs.

Speaker 1

Please turn to Slide 5.

Speaker 2

Thank you, Erica, and thank you, everyone, for joining us today to discuss our Q2 2023 financial results and operational highlights. Since our last earnings call, the entire organization has continued to focus on our 3 priorities 1st, delivering an updated product for the upcoming fall season 2nd, reducing our rate of spend, managing our cash flow and evolving our scale and structure and third, deriving additional value from our technology platform and portfolio via the advancement of our pipeline and business development activities. I'm pleased to share with you today the significant We've made on all three of these priorities for Novavax. Let's start with our first priority, delivering an updated product for the upcoming 2023 fall vaccination season. Thanks to our comprehensive strain change strategy and commercial readiness efforts, We are well positioned to achieve this objective and reiterate our plan to deliver our updated vaccine on time for the fall season.

Speaker 2

Importantly, we believe we have a competitive product profile and have produced an ample supply to meet anticipated demand this season. We have initiated our filing for authorization in the U. S. And are preparing to file our submissions in the coming weeks in other key markets. For the U.

Speaker 2

S, our commercial team is fully deployed and focused on ensuring our vaccine is widely available and accessible. Outside of the U. S, our sales continue to be driven by existing APAs with committed orders intended for delivery in the Q4 of this year. We are confident in our readiness to deliver an updated, differentiated and competitive vaccine for this fall season. In most of our key target markets, including the U.

Speaker 2

S, our vaccine, if authorized, would be the only non mRNA protein based option available, And we're excited about the potential to offer our vaccine as an important alternative to consumers around the world. John Trizzino will share more about our commercial readiness later in the call. So let's move on to priority number 2, which is to reduce our

Speaker 3

rate of

Speaker 2

spend, manage our cash flow and evolve our scale and structure. We continued to make significant progress towards strengthening financial position during the Q2 with the intent of building a solid financial foundation for long term value creation. Commercial execution is an important contributor to our financial health. And for the Q2, we recorded total revenue of $424,000,000 which brings us to over $500,000,000 in revenue for the first half of the year. During the quarter, We also successfully executed and amended APA with Canada, a long term valued customer.

Speaker 2

This agreement established The foundation for ongoing supply of our COVID vaccine and negotiated up to $350,000,000 in cash payments to Novavax for 2023, further strengthening our cash position as we head into the fall season. The enhanced partnership with SK Bioscience that we announced earlier today includes an $85,000,000 equity investment in NOVAVAX at a 59% premium to the stock's 90 day volume weighted average price. This mutually beneficial arrangement evolves our relationship with SK from a contract manufacturing organization to a strategic business partnership, Extending SK Biosciences' commercialization rights in certain markets, providing Novavax with a milestone payment and future royalties for from our balance sheet in 2023. We are also on track with the global restructuring and cost reduction plans announced last quarter And as of today, have reduced current liabilities in 2023 by over $1,000,000,000 Ending the Q2 with over $900,000,000 in cash and receivables. You will hear more today about our cost Management, liability management, cash flow and full year 2023 outlook from Jim Kelly later in the call.

Speaker 2

Finally, let's discuss priority number 3, which is to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond NuvaXivit alone. Starting with our pipeline. As COVID evolves into a seasonal public health challenge along with other respiratory viruses, we are keenly aware of the emerging need for combination vaccines. Therefore, as a first step, Novavax has made it a strategic priority to develop our combination vaccine for COVID and influenza. Based on what we see as a robust emerging need and market opportunity, our improving balance sheet and recent progress on our corporate priorities, we've decided to make Strategic stage gate investments in 2023 2024 to independently prepare this new product candidate for late stage development and importantly can do so in line with our stated financial targets.

Speaker 2

In parallel, we will continue to evaluate the potential to partner this program I look forward to sharing updates with you as the program progresses. Moving on to Matrix M Collaborations. Our Matrix M adjuvant is one of the keys to our unique technology platform and continues to offer potential value for both Novavax and our business partners. The R21 Matrix M adjuvanted malaria vaccine developed by Oxford University and manufactured by Serum Institute of India Has received authorizations in multiple countries this year and has the potential to be an important tool in the fight against malaria around the globe. As part of this arrangement, Novavax expects to supply and receive payment for Matrix M in support of launch readiness and will be eligible to receive royalties on future product sales.

Speaker 2

We also recently announced a new collaboration with the Bill and Melinda Gates Medical Research Institute for use of our matrix Am adjuvant in preclinical We have also expanded our discussions to explore the use of our matrix M adjuvant in clinical development programs, and we look forward to our continued partnership an important work towards our shared goal of improving global public health. As I have said since I joined Novavax CEO in late January of this year. We intend to share our successes and opportunities as well as our challenges and risks with you in a transparent manner. So let me be clear. While we are all excited about the progress we've achieved year to date on our key priorities, I want to be clear that there is still significant execution risk for our business ahead of us as we seek regulatory authorizations for our first updated version of NuvaXivit and prepare to compete in the U.

Speaker 2

S. Market as it converts to a commercial model for the first time. Our success as a company will depend in a large part On our continued ability to deliver on these priorities and on the emerging opportunity for COVID vaccination around the globe as the pandemic enters an endemic phase. As we continue to prepare for what should be an exciting opportunity this fall season, I am personally encouraged by the commitment and energy of our management team and all of our employees and sincerely grateful for the support of our loyal investors. You have our continued commitment to give you our best effort and our focus on the key priorities we have outlined.

Speaker 2

Now I would like to hand it over to additional members of the team to discuss our results from the quarter and in more detail, Beginning with John Trizzino to discuss our commercial updates. John?

Speaker 4

Thanks, John. Please turn to Slide 6. Novavax's COVID vaccine is authorized for use in over 40 countries around the globe. Leading into the 2023-twenty 4 fall vaccination season, Many of these countries are still purchasing COVID vaccines under advanced purchase agreements, APAs, while In the U. S.

Speaker 4

Moves to traditional vaccine purchasing and commercial operations. Today, I will be discussing specific activities and readiness for each region. Please turn to Slide 7. The U. S.

Speaker 4

As planned is exiting the pandemic phase and entering a more We have been preparing for commercialization in the U. S. Throughout the pandemic phase, and we are ready organization wide For availability of product as soon as September, of course, dependent on our FDA strain specific authorization and ACIP recommendations for use. As you would expect, there has been significant collaboration across many U. S.

Speaker 4

Agencies and within HHS to ensure that this transition is executed smoothly and there is vaccine available for anyone interested and receiving a COVID vaccine. Critical updates and prioritization of public health objectives over the past few months have provided greater clarity for the upcoming vaccination season and focused our preparation. Let me highlight some of the most important and significant items. Based on the evaluation and recommendation from VIRPAC, The FDA selected the XBB1.5 as the monovalent strain for the 2023, 2024 COVID season. Novavax has been manufacturing this new variant strain at commercial scale based on the final strain recommendations in June.

Speaker 4

Our updated XBB COVID vaccine is on track to be in our U. S. Facility in September and immediately available for distribution and use upon authorization. 2, HHS Secretary, Bracera, outlined 4 priorities for the transition to traditional commercial access of COVID vaccines. Novavax is working to support these priorities by producing sufficient supply of vaccine, ensuring low income and underserved populations to provide free vaccine to those without insurance coverage, providing a competitively priced vaccine that removes pricing as a barrier to access and working with the U.

Speaker 4

S. Government to share distribution and vaccination data for our XBB COVID vaccine. 3, the CDC plays a critical role on multiple fronts for the success of this first season, And I am pleased to report that Novavax has contracts and negotiated pricing in place with the CDC and other entities, including That for the Vaccine for Children's program funding that has made vaccine available for low income children since 1994. 4, Novavax believes based on its own analysis and consensus across multiple sources That the U. S.

Speaker 4

Market demand for COVID vaccine this fall will range from 80,000,000 to 100,000,000 doses. Of course, market demand and the number of doses needed across all channels and populations in the U. S. Can only be estimated And we will only know for sure as the respiratory disease season unfolds. What we do know with more certainty is That COVID vaccine strains continue to circulate and there is great value in a safe and effective vaccine to help prevent and to reduce the most severe complications of COVID disease and that Novavax is on track to be ready this fall with ample COVID vaccine supply in support of U.

Speaker 4

S. Public health needs. With these imperatives in mind, We have put forth tremendous effort to ensure that we are organization wide ready for the 2023 2024 COVID season. Please turn to Slide 8 and allow me to detail specific activity. A core focus for us is manufacturing readiness.

Speaker 4

We have been manufacturing our updated XBB COVID vaccine at commercial scale, which will enable us to supply tens of millions of doses of our vaccine In line with our planned demand for the fall season, we expect to have doses in our U. S. Warehouse in advance of FDA's authorization and ACIP's policy recommendations to ensure that we can quickly ship initial stocking orders to customers in September. We are also keenly focused on our commercial readiness. Central to our fall initiatives has been the execution of our targeted Commercial contracting strategy.

Speaker 4

We continue to believe that the COVID vaccine market dynamics and the channels of distribution will be comparable to the annual seasonal influenza vaccine market. This market intelligence drives our strategy to make our vaccine available To the commercial, government and public health affiliated network of vaccine program stakeholders that are responsible for administering the majority of vaccinations. This target group Consistently offers and administers greater than 150,000,000 flu vaccinations across the country every Fall and winter respiratory virus season. Execution of this strategy means we will make our COVID vaccine available via 3 key healthcare provider channels and buying groups. This would include, but may not be limited to the following: Retail Pharmacy, of course, all national, regional and independent pharmacies integrated delivery networks and physician buying groups and public health access via the CDC, VFC, Department of Defense and Indian Health Services.

Speaker 4

This strategy is also dependent on and requires the utilization of a network of well known and highly experienced vaccine distribution partners to deliver our product to the various points of service across the country. To that end, once authorized, any vaccinating health care provider All vaccinating organization interested in acquiring our vaccine will have a familiar selection of participating distributors that should provide for easy access to our vaccine. Having spent time in my career in the vaccine distribution Space, I truly understand and value what our distribution partners bring to Novavax, our customers and to the consumers who will receive our vaccine. To date, we have established critical relationships with key provider and retail buying groups and executed distribution contracts that ensure national widespread availability to HCPs and ensure consumer choice in their COVID vaccine selection. Our recent progress includes the following: distributors contracts signed or in process that covers 100 percent of 3 priority healthcare provider channels.

Speaker 4

Pharmacy contracts signed or in progress representing approximately 80% of vaccines administered in pharmacies, CDC and other government services such as VA, DoD and Indian Health Service contracts are signed and coordination is in process for dose availability per the respective agreements. GPO and PPG contracts, Physician buying group contracts signed or in final stages will provide access to office based providers associated with the top integrated delivery networks and major medical groups that drive 90% of the vaccinations within these organizations. These relationships will ensure we have availability and broad access to key providers and pharmacies to support patient choice of their COVID vaccine. We feel confident that our overall strategy will create convenient nationwide access To our vaccine for any consumer seeking it as well as any healthcare provider who would like to acquire our vaccine for their COVID vaccination program this fall. And finally, we have implemented a commercial pricing strategy that will reflect The overall value that our vaccine delivers, allowing us to achieve broad access to competitively position our vaccine.

Speaker 4

We continue to see a significant market opportunity in the U. S. Based upon our commercial readiness efforts. We remain confident in our ability to capture a meaningful market share during the upcoming fall season and beyond. Please turn to Slide 9.

Speaker 4

Ex U. S, we expect total revenue of approximately $700,000,000 from APA orders For 2023, based on committed dose delivery schedules, subject to updated variant manufacturing regulatory approvals, And I'd like to share some details about how this breaks down. In the EU, we will be completing our COVID vaccine shipments against the original APAs Before the end of this year, when we expect to deliver the remaining 17,000,000 committed doses, the relationships established during the pandemic We remain strong across the EU and our commercial organization deployed against key EU markets, including Germany, Spain, France, Italy and Switzerland. We look forward to 2024 and the shift to traditional commercial vaccine distribution, both in the private and tender markets. We expect to continue to grow share in these key markets based upon the expressed need For the non mRNA option and Nuvexovid's position as a safe and effective protein based vaccine approved for use in the EU.

Speaker 4

In Canada, we amended our APA, which provided for payment of forfeited doses in 2023, Reinforced our commitment to establish in country manufacturing in 2024 and 2025 and also extended dose purchasing commitments into 2024 and 2025. We are excited to have strengthened our partnership with Canada and establish a foundation for continued vaccine supply. Finally, in Asia Pacific, we have similarly created strong relationships with our country partners in this region. We While some APAs continue into 2023 2024, we are beginning to execute against traditional vaccine tender purchasing policy. Interest in Vaccine Choice remains high with specific focus on the need for a non mRNA choice of a protein based vaccine.

Speaker 4

Regarding ongoing label expansion and policy recommendations, across all of our priority markets, we are engaged with regulatory authorities and policy making bodies to expand our label and advance policy recommendations that will enable broad market access. We are generating data from our Phase IIbIII global clinical trial to support expansions to our label in younger children 6 years of age to 11, which Philip will discuss in more detail shortly. And We are making important progress towards ensuring access to our product through supportive policies. As an example, Germany's policy body, the Robert Koch Institute recently expanded their recommendation for vaccines this fall to include all licensed and variant adapted vaccines Regardless of technology platform, this increasing policy support further drives our confidence that our updated XBB COVID vaccine will be accessible this fall. We are also pursuing full approvals in key markets, which will establish the foundation for future regulatory approvals of our updated vaccine.

Speaker 4

Last month, we received our first Full marketing authorization in the EU as a primary series for ages 12 and older and as a booster dose in adults. We are also preparing to file for full approval in other key markets. In the U. S, we have initiated the rolling submission of our BLA filing, And we intend to submit the remainder of our data over the coming months. While full approval via the BLA process will be an important milestone for us early next year, We will be able to sell and market our updated XBB COVID vaccine for the upcoming 2023 full vaccination season under emergency use authorization.

Speaker 4

Regarding competitive product profiling and positioning, in the majority of countries where we have APAs And in the U. S, our vaccine, if authorized, would be the only non mRNA XBB protein based COVID vaccine option, allowing our vaccine to serve as an important alternative to consumers and healthcare professionals. As we prepare to deliver our updated vaccine for the fall, we remain confident in the competitive product profile of our vaccine. With that said, I'd like to hand it over to Philip to discuss updates for our clinical development and pipeline.

Speaker 5

Thanks, John. Please turn to Slide 1011. Today, I'd like to cover 3 topics. First, I'll update you on our STRATE CHANGE study, which is our number one priority. Now I'm going to share some new pediatric data before I touch base on plans for our clinical pipeline.

Speaker 5

Please move to Slide 12. Study 311 Part 2 is a key study upon which our XEB strain change regulatory filing is based. This study compared our The study design was agreed upon with regulatory agencies to support the upcoming strain change filing for XUV-fifteen. Here are the important findings from the study. We achieved all 3 co primary endpoints.

Speaker 5

The bivalent vaccine induced a superior neutralizing response against BA. 5 compared to the prototype strain vaccine. It also generated a non inferior BA. 5 seroconversion response and non inferior neutralizing response to prototype. As an aside, the monovalent BA.

Speaker 5

5 vaccine was more immunogenic than the bivalent, a finding that recapitulated the preclinical data we discussed in the June VERPAC. And finally, all formulations had similar reactogenicity profiles. Findings from both the BA. 1 and BA. 5 parts of the 3 11 study Provide reassurance that our manufacturing is consistent and the various strains perform comparably.

Speaker 5

These data have been submitted to the FDA to In addition to updating our vaccine for the fall season, we continue to work Expanding our label to include the pediatric population. Please go to Slide 13. Study 503 is our global pediatric Age de escalation study being conducted in children 6 months of age to 11 years of age. Enrollment is complete in the 6 to 11 year old cohort And the 2 to 5 year olds, but is ongoing in the youngest children. The data on this slide is preliminary top line data for the 6 to 11 year old cohort.

Speaker 5

On the right hand side, we displayed validated neutralizing responses after 2 doses. As a group, the children achieved a TIDR of 5,380, which represents a geometric fold rise of over 21 fold. To put this value in context, this is 5 fold higher And seen in our adult Phase 3 study conducted in U. S. Mexico, which was associated with high levels of protection.

Speaker 5

The protocol defined primary effectiveness endpoint was to demonstrate the immune responses in children was non inferior to the immune responses in young adults in the U. S. Mexico Phase 3 study. The children's immune responses was non inferior for both the geometric mean titer as well as seroconversion rate. Overall, we saw a reassuring safety profile through 28 days post dose 2.

Speaker 5

The unsolicited adverse events and medically attended adverse events were balanced between vaccine and placebo and represented common childhood illnesses. There were no related SAEs, no related severe events, no adverse events of special interest, no myocarditis and no pericarditis. Please move to Slide 14 to look at reactogenicity events. Here we've displayed reactogenicity events after dose 1 on the top The slide and dose 2 on the bottom of the slide. The local symptoms are on the left hand side in blue and systemic symptoms are in green on the right.

Speaker 5

For each term, most children reported no symptoms. And when they did have symptoms, the vast majority were reported as mild or moderate. There was no significant increase of symptoms between dose 1 and dose 2. We think our vaccine may play a special role in the pediatric population. The vaccine appears to be very well tolerated, while inducing robust neutralizing responses.

Speaker 5

This profile, in addition to our classic recombinant protein technology, may be reassuring when parents and providers choose vaccines for children. We expect to submit these preliminary results to the EUA in the 4th quarter. And while the length of regulatory review is not known, we believe that approval of a EUA amendment could occur in early 2024. Let's move to the next slide, Slide 15, and review our plans for the clinical pipeline in support of our 3rd corporate pillar. Last quarter, I shared some top line data from our clinical programs, and we are still awaiting final humoral and cellular immune readouts to finalize formulation decisions.

Speaker 5

But as John mentioned, we've made some stage gated investments to keep development on track. For our COVID influenza combination vaccine candidate, showed immune responses from the combination were comparable to licensed influenza vaccines as well as our authorized COVID vaccine. This is a priority pipeline asset for us Because there's consumer and medical provider preference for a combination of vaccines, we will be investing in developing a co formulated vaccine in preparation of the Phase 2 study planned for next year. The purpose of the Phase 2b study will be to establish a robust safety database for the co formulated product and confirm the previous immunogenicity. We believe the Stage Care divestment will provide all the data needed for regulatory interactions prior to our Phase 3 decision example, through strategic partnerships.

Speaker 5

For our standalone influenza vaccine candidate, we showed you our vaccine induced wild type HAI responses that were overall better 2 market leading licensed vaccines. While the combination COVID influenza vaccine will be our primary focus, the clinical development plan does maintain an option to take the standalone flu product advanced development. We also recognize that our influenza vaccine platform may be attractive from a pandemic preparedness perspective, because has been elusive with other vaccine technologies. And finally, for our high dose COVID vaccine candidate, we shared our immune responses were improved With higher antigen doses without increasing reactogenicity, and we plan on starting a high dose COVID vaccine study in older adults in the Q4. Now these 3 vaccine candidates exemplify the inherent flexibility and potency of our adjuvanted recombinant protein nanoparticle technology.

Speaker 5

We can induce very broad immune responses and long lived cellular responses. You've seen that we use can use high antigen doses without compromising tolerability. This is critical as we think about high anti dose applications for difficult to immunize populations such as older and allows us to modulate antigen dosage levels in combination of vaccines to overcome hematologic interference. These features are important and potentially differentiate our products. The vision is to leverage these attributes and establish a leadership position in the seasonal Respiratory viral vaccine space.

Speaker 5

We think the space will be dominated by combination vaccines and target a number of pathogens me hand it off to Jim to discuss our financial results.

Speaker 6

Thank you, Philip. This morning, we announced our financial results for the Q2 of 2023. Details of our results can be found in our press release issued today and our 10 Q filing. In addition, we also announced this morning execution of agreements with SK Bioscience that enhance our strategic business partnership and include an $85,000,000 equity investment in Novavax at a 59% premium to the 90 day volume weighted average price. I'll begin by providing an overview of our on our global restructuring and cost reduction plan.

Speaker 6

Finally, I'll share an update on our financial guidance for the full year 2023. Please turn to Slide 17. For the Q2 of 2023, we recorded $424,000,000 in total revenue, reflecting a $239,000,000 and 128 percent increase as compared to the Q2 of 2022. Combined R and D and SG and A expenses for the Q2 of 2023 were 313,000,000 This reflects an $85,000,000 or 21 percent decrease compared to the Q2 of 2022 and a $46,000,000 or 13% decrease compared to the Q1 of 2023. This improvement represents the continued Additionally, in the first half of twenty twenty three, we reduced our outstanding liabilities by $864,000,000 including A $323,000,000 reduction in the Q2 of 2023.

Speaker 6

With the SK Bioscience announcement today In settlement of related manufacturing agreements, the reduction to current liabilities now exceeds $1,000,000,000 for the year. And finally, We ended the Q2 with $518,000,000 in cash and accounts receivable balance of $395,000,000 for a combined total of over $900,000,000 as we head into the fall vaccination season. Please turn to Slide 18. Beginning with revenue, our Q2 2023 performance benefited from improvements to both product sales of nabaxavid And grant revenue, as we recorded total revenue of $424,000,000 compared to $186,000,000 in Our cost of sales for the Q2 of 2023 were $56,000,000 compared to $271,000,000 in the Q2 of 2022. This includes $2,000,000 related to excess, obsolete or expired inventory and losses on firm purchase commitments as compared to $255,000,000 in the same period in 2022.

Speaker 6

Research and development for the Q2 of 2023 were $219,000,000 compared to $290,000,000 for the Q2 of 2022. The decrease was primarily due to a reduction in clinical and manufacturing spend. Selling, general and administrative expenses for the Q2 of was primarily due to a reduction in spend by corporate support functions as outlined in the global restructuring and cost reduction plan announced in May. Q2 of 2023 total operating expenses included $15,000,000 in one time restructuring costs related to workforce reduction, fixed asset write offs and the consolidation of certain facilities, of which $12,000,000 was recorded in SG G and A. These charges reflect substantially all of the restructuring costs we expect to record under our restructuring plan.

Speaker 6

For the Q2 of 2023, we recorded net income of $58,000,000 compared to a net loss of $510,000,000 in the Q2 of 2022. Please turn to Slide 19. Today, we announced new agreements with SK Bioscience that reflect the evolution of our relationship from a contract manufacturer arrangement To a strategic business partnership, including an equity investment by SK Bioscience and Novavax. First, The upgraded agreements extend SK Biosciences' commercial rights in South Korea, Thailand and Vietnam and provides for a $4,000,000 milestone to Novavax in return for the extension of these rights in addition to existing economic terms, which include royalties on future product sales in those markets. 2nd, SK Bioscience is making an $85,000,000 equity investment in Novavax common stock at $13 a share, reflecting a 59% premium the volume weighted average price over the 90 days prior to August 8, 2023.

Speaker 6

3rd, The agreements settle $195,000,000 in outstanding Novavax contract manufacturing liabilities for $154,000,000 In total, under these agreements, Novavax will issue 6,500,000 common shares and pay net cash $5,000,000 to SK Bioscience to settle $195,000,000 in current liability as of June 30, 2023. Please turn to Slide 20. We've made significant progress to reduce our outstanding current liabilities, including the reduction of $323,000,000 during the Q2 $864,000,000 in total for the first half of twenty twenty three. And as we just discussed, The SK Bioscience agreement announced today further reduces our current liabilities by $195,000,000 for a total reduction of over $1,000,000,000 year to date in 2023. Please turn to Slide 21.

Speaker 6

In May, we announced our global restructuring and cost reduction plan. Today, we remain on track to Significantly reduce Novavax's expenses by retaining capabilities needed to drive results and build future value. For the full year 2023, we reiterate our target to reduce our annual combined R and D and SG and A expenses to between $1,300,000,000 $1,400,000,000 reflecting a 20% to 25% reduction as compared to 2022. For the full year 2024, we also reiterate our target of R and D and SG and A expenses of below $1,000,000,000 reflecting a 40% to 50% decrease when compared to 2022. Importantly, We've been able to further reduce our anticipated cost structure to allow us to now include one time restructuring cost and strategic stage gate investments to advance our kick flu program towards late stage development 2023 2024, while maintaining our R and D and SG and A expense guidance.

Speaker 6

In summary, we are on target with our plans to reduce our R and D and SG and A scale and cost structure by 40% to 50% in 2024. And receivables, all supporting our intent of building a solid financial foundation for long term value creation. Please turn to Slide 22. Before discussing our full year 2023 financial guidance, I am pleased to share that since April, we've secured up to approximately $600,000,000 in cash to improve our cash runway.

Operator

The up

Speaker 6

to $450,000,000 in cash payments negotiated this year under our Canada APA represent an important source of non dilutive funding for the company. In addition, we've raised $153,000,000 of equity capital Through an $85,000,000 investment by SK Bioscience and $68,000,000 in equity raised through our ATM program at an average combined price representing a significant premium to our 90 day volume weighted average price. I'd like to spend a moment on the accounting associated with the up to $450,000,000 in non dilutive Cash payments in 2023 related to forfeited doses. These amounts will be initially recorded as deferred revenue along with existing related upfront payments for these forfeited doses. These combined amounts will later be recognized ratably As product sales between 2023 2025 as the remaining performance obligations are met under the amended Canada APA, We do not expect this to be a material contributor to 2023 product sales.

Speaker 6

Regarding payment timing, we received the initial $100,000,000 cash payment related to the April 20 The first $175,000,000 payment was received in July 2023 and a second $175,000,000 payment is contingent and payable upon delivery of vaccine in the second half of twenty twenty three. Of note, for our full year 2023 revenue guidance, dollars 100,000,000 of the up to $350,000,000 cash payments Associated with the June APA amendment was included in the prior full year 2023 product sales and total revenue guidance. For this reason, we are removing this $100,000,000 cash payment from our full year 2023 revenue guidance. With that said, let's turn to our full year 2023 financial guidance. We expect to achieve full year 2023 total revenue of between $1,300,000,000 $1,500,000,000 including product sales of between $960,000,000 $1,140,000,000 and grant revenue of between $340,000,000 $360,000,000 Our full year 2023 product sales guidance includes US market product sales of between $260,000,000 $440,000,000 and approximately $700,000,000 in APA product Sales based on 2023 committed dose delivery schedules, each subject to updated variant manufacturing and regulatory approvals, as well as successful pull through in the U.

Speaker 6

S. Market. In the first half of twenty twenty three, We recorded $505,000,000 in total revenue, which is in line with the expected phasing of total revenue guidance provided in May. As a result, we expect total revenue of approximately $800,000,000 to $1,000,000,000 in the second half of twenty twenty three. In addition, we expect that our updated XBB COVID vaccine product sales will materially occur in the Q4.

Speaker 6

This is based on the recent U. S. FDA announcement for plans to approve updated COVID vaccines in late September, plus the expected time and for other regulatory approvals and deliveries of our updated XBB COVID vaccine outside the U. S. For expenses, as I mentioned earlier, we are reiterating our targets to reduce our combined R and D and SG and A expenses for the full year 2023 2024.

Speaker 6

Of note, our combined R and D and SG and A expenses for the Q2 of 2023 were 313,000,000 The midpoint of our full year 2023 R and D and SG and A guidance range implies an approximately $340,000,000 quarterly run rate for the second half of twenty twenty three. In the coming quarters, we expect to see a Seasonal increase in our sales and marketing investments as our commercial team executes during the fall 2023 vaccination season. If successful in achieving the full year 2023 guidance outlined today, we believe this will The funding of our operations for the next 12 months. In our 10 Q filing, you will see that we have provided an update on our Going concern disclosure, which we first provided in our 10 ks filing in February. Specifically, That this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months, funding from the U.

Speaker 6

S. Government and pending arbitration. 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. Please turn to Slide 23. I'd like to close today's call by reiterating the important progress We've made on all three priorities for 2023. The updates we shared today reflect meaningful progress against our priorities, which are intended to place Novavax on a path to success both this year and beyond. During the past quarter and through mid year, We have under priority 1, continued to prepare for the fall season and have now manufactured our XBB vaccine at commercial scale with ample supply, Initiated our regulatory filing with FDA and have our commercial team fully deployed with the majority of U.

Speaker 2

S. Commercial contracts completed or in progress to ensure broad access to our vaccine this fall. Priority 2, so we've significantly reduced our current liabilities by over $1,000,000,000 and in parallel Have built a cash and receivables balance of over $900,000,000 as we head into the fall vaccination season. We are also on track with our cost reduction initiatives. And in addition, we're able to absorb our one time related restructuring charges within those stated targets.

Speaker 2

Under priority 3, We will be advancing our pipeline of future assets with a priority focus on our new combination vaccine program and secondarily, our standalone flu program, as Philip outlined earlier in the call. Regarding business development, we signed a new agreement with SK Bioscience that includes an $85,000,000 investment in Novavax at a premium and removes the $195,000,000 current liability from our balance sheet. In addition, new approvals were achieved for the And we were proud to announce that we signed an agreement with the Bill and Melinda Gates Medical Research Institute to advance several vaccine development programs using our Matrix M Technology and look forward to furthering that partnership. When I first joined you all in February for the Q4 earnings call, I pledge to you our commitment to be transparent about our opportunities as well as our challenges and to provide a balanced perspective on our progress. With this commitment in mind, I hope you can see from today's announcements that we have made significant progress on our key priorities so far this year and have overcome several of the barriers to success we have highlighted since my arrival.

Speaker 2

And importantly, that these successes That being said, we cannot yet claim a successful year as there is still much work to be done with significant execution risk ahead of us. Much of our success this year will be dependent on how and when regulatory authorities react to our filings, how the fall season including demand for COVID vaccine in general, and we will need to continue to execute successfully against all of our objectives. I want you to know that I am confident in our management team and in our organization's desire and focus to advance our objectives. It is with humility that I give you our full commitment to continue these efforts with a goal of delivering our vaccine this season to consumers around the world and doing our best to deliver a successful performance for our company and our shareholders and all key stakeholders in 2023. With that, we will now take your questions.

Operator

We will now begin the question and answer session. First question will come from Roger Song with Jefferies. You may now go ahead.

Speaker 7

Great. Thanks for taking the question and congrats for all the progress.

Speaker 2

Thank you, Roger.

Speaker 7

Thank you, John. So a couple of questions from us. Maybe first to focus on the U. S. Market.

Speaker 7

So for the X BB filing you already started. So just curious what's left to be submitted? Is that possible you will They will FDA will need to see XBB clinical data versus the BA. 5 data you already have on hand. Any risk of supplying be able to meet all the requirement by late September?

Speaker 7

Maybe that's one part of the U. S. Question. And the other part is the what are the key driver for you to be able to gain meaningful market Here in the U. S.

Speaker 7

For this call, specifically maybe talk about the pricing strategy and in your 10 Q, we see your dose Presentation is 5 versus 1 dose, any impacts on there? Thank you.

Speaker 2

Thank you, Roger. Philip, would you take Roger's first question please on the FDA

Speaker 5

Sure. So we've already submitted the preclinical and clinical packages and we're going to complete that file this month. We previously discussed with the FDA the need for what kind of clinical data we need and that's why we connected the study we did. The XUB5 data is adequate, not only for the U. S, but globally for approval for the XUV-fifteen.

Speaker 5

And our plan is to have the product available in time for the FDA CDC release at the end of September.

Speaker 2

Thank you, Philip. And John Trazino, would you like to take the U. S.

Speaker 4

Yes. Sure, John. Thank you. Hey, Roger, thanks. Key drivers I've been somewhat outlined in the script, but to review a big piece of this is an access strategy being able to make sure that all markets have Well, market segments have availability to the vaccine.

Speaker 4

We've talked about distribution, pharmacy, national, regional, the healthcare provider offices, public health. These are all Our key participants in our strategy to make sure that we have the non mRNA vaccine or protein based vaccine available and accessible Across that entire spectrum. Pricing strategy, we're in line with what's been publicly stated, about $130 of WACC. All of that gets incorporated into a reimbursement strategy that makes us in a competitive Lee, Advantage situation here to be sure that all of that vaccine is being purchased through the normal channels. And as we think about what those normal channels are, it's the normal annual seasonal flu vaccine means of getting to the healthcare provider and to The consumer.

Speaker 4

I think it's critical to understand here that we had very limited access of our vaccine during the last Season 2 government contract purchasing and late approval of our vaccine. We are now well positioned with inventory to be in warehouses starting In September, the distribution network in place and a strong desire for the consumer market and the healthcare provider To be trying the protein based vaccine.

Speaker 7

Great. Thank you. Maybe next question is regarding the financials. So very glad to see your financial position Proved significantly. And also, Jim, you mentioned on the call, if all the operational When is successful, you can remove your going concern.

Speaker 7

That's key for investors, I believe. And maybe just elaborate on that point a little bit. What, When and under what condition you will potentially remove the going concern in the next 12 months? Thank you.

Speaker 2

Yes. Jim, Kelly, you can take that question.

Speaker 6

Certainly. And you're exactly right that this is an area of high interest for investors, our financial health. We really think we've made Significant progress. As you heard us mention, we have $900,000,000 as of $6.30 in both cash and receivables. And we just announced a really important improvement in our strategic partnership with SK that certainly eliminates further liabilities.

Speaker 6

When it comes to the going concern, you are correct that it is further disclosed in our 10 Q and we look forward to providing more updates, Especially in light of our performance this fall in the updated vaccine commercial marketplace. And I think that's About what we can say right now, I think the we're optimistic with our operating plan. We continue to execute well. And then if we do so, that would be in line with our expectations that with the appropriate execution, We endeavor to remove that going concern. So more on that in the future.

Speaker 7

Excellent. Thank you for the comments. That's it from us.

Operator

Our next question will come from Eric Joseph with JPMorgan. You may now go ahead.

Speaker 8

Good morning. Could you clarify whether the updated XBB vaccine would be available as a Single dose or multi dose format for the U. S. Fall campaign. I'm also curious to know whether any of the Whether a single dose format is required by any of the national or regional PBMs?

Speaker 8

And then I have a follow-up.

Speaker 2

Thank you, Eric. John T, you want to take that one?

Speaker 4

Yes, please. Yes, thank you. Yes, we will be providing 5 dose vial presentation, which is a reduction from our previous 10 dose. We have been talking about unit dose files on assessment of what market conditions are looking like. There's to be sure that we had sufficient supply and then sufficient timing parameters.

Speaker 4

The decision was made to go with the 5 dose vial. There is no Specific prevention from having a multi dose vial and the reality is we still have refrigerator stability while others are still being shipped frozen product, Ease of administration of the 5 dose vial and certainly making sure that there are no barriers to the use Of the 5 dose vial, and that's being communicated and coordinated with all of our customers, distributors, pharmacies, health care providers, etcetera.

Speaker 2

Okay. And now, Mike, you had a follow-up question?

Speaker 8

Yes, I did. That's very helpful. Thanks, Don. Maybe just picking up on your comments about Pricing, and you made a note about WACC, but your comments signaled being Competitively priced, I guess, what should we be thinking about in terms of discounts or really net price? Is there a range that we should be modeling in the U.

Speaker 8

S?

Speaker 4

Yes. So we're not going to disclose the specific contract pricing terms. But as you can imagine, as part of the overall are being taken into consideration for what they're purchasing for, what the health care providers Are being reimbursed for and knowing that that's an important calculation for that strategy. So contracting across All channels. In particular, I've mentioned pharmacy, I've mentioned office space physicians, but office space physicians are in categories of integrated delivery networks, Our physician buying groups, and so therefore that contracting strategy significantly affects their decision making.

Speaker 8

Final one, if I could. Just thinking of last one here. With respect to the remainder of deliveries under APA in the Are you effectively done with distributing the Wuhan strain at this point? Or should there be some pull through still in the second half of that format? I guess, and if that's not the case, I guess, what's the timing that you expect to sort of be ready with XBB strain delivery in that region?

Speaker 8

Thank you. Yes.

Speaker 2

Go ahead, John.

Speaker 4

Yes. So Eric, all of our shipments in the fall will be the variance train XBB. The different regions have different rollout of the APA. So APAs in EU are finishing up before the end of this year and we're going to be shipping all that product. Then Canada, Australia, New Zealand, Taiwan, Singapore all have additional APA shipments to be coming, But we're all in all cases, whether that we still have an extension of APAs, there will be ongoing and already in place execution of commercialization strategies either in the private market or the tender markets.

Speaker 4

In the script, I made reference to several key markets in the EU Our attention will be focused on those markets as we go into the 2024 season. So we understand what those situations are. We also understand, especially in Europe, about the Pfizer settlement in Europe against their contract. However, that still leaves more than sufficient market share available for us to acquire. And again, all those conversations and negotiations already in process for the future.

Speaker 4

Great.

Speaker 9

Thanks for taking all the questions.

Speaker 2

Thank you, Eric.

Operator

Our next question will come from Brenton Smith with TD Cowen. You may now go ahead.

Speaker 3

Hi, guys. Thanks so much for taking the questions and congrats on the quarter.

Speaker 5

Thank you, Brennan. A couple

Speaker 10

of quick ones from

Speaker 3

us kind of building on, I think, the last couple of questions. I guess really to your point about the APAs, I wanted to also ask if you're still planning to or maybe currently negotiating with any of these governments Do you try to monetize any of the remaining APs? Or are you expecting at this point to really just go ahead and fill them fill the rest as is? And then I guess one last question on the remaining supplies of the Wuhan vaccine. If we should maybe expect any, I don't know, So write offs or disposal of the existing doses, or really what your plan is for any outstanding supplies there as we kind of move into the fall with the XBB booster?

Speaker 3

Thanks.

Speaker 2

John, do you want to take the first question? Yes.

Speaker 4

Let me because I think Eric may have asked the same question too, but let me just come back to So for the remainder of shipments to be made for the balance of this year will all be under the variant strain vaccine. XBee Will be what the strain included in the vaccine will be. No additional Wuhan shipments will be made. We for this period of time have complied with the VERPAC recommendations of the variance strain to be included That we will continue to do throughout all of the various regions that we're engaged. The APAs Are a little bit different country by country.

Speaker 4

So no APAs to contend with in the U. S. It's a wholly commercial market. Canada, for example, will continue Under the amended APA, we'll continue for 2024 and 2025 under APA, and we continue to talk with them long term About what their COVID vaccine needs are, Europe ends with this year, but conversations on a country by country for what might either be their tender market or private market. And then similarly with Australia and New Zealand, those APAs have been amended to continue for another 2 years.

Speaker 4

In every case, the relationships established during the pandemic Continue to be strong on a country by country basis. They've been very cooperative and flexible with us. In all cases, we've retained the full contract value of the APA. So we will either continue to ship updated variant vaccine, or manage that through future purchase commitments to be satisfying against

Speaker 2

Those obligations. And then Jim Kelly, the second question on the or any potential write offs from Wuhan.

Speaker 6

Yes, exactly. We don't anticipate any write offs associated with Wuhan and I think you noted in our COGS this quarter, I think it's about $2,000,000 in expiry and obsolescence. So we've cleared our balance sheet of those items and we're fully focused delivering the updated vaccine this fall. I'll just reiterate what John just said about getting all the Wuhan vaccine to our customers. We are fortunate.

Speaker 6

Our customers requested to have Wuhan delivered by Q2 and we delivered on that. And that was a part of, I think what people are happy to see in our top line this quarter and when you think about our guidance that we've given just in terms of phasing of revenue, We had said about 1 third or $500,000,000 we expected before the fall season. Well, we did just that. And so the remaining 800

Speaker 3

All right, great. Thanks, guys.

Operator

Our next question will come from Mayank Mamtani with B. Riley. You may now go ahead.

Speaker 10

Good morning, team. Great to see solid execution against your plan. I appreciate

Speaker 5

your kind of transparency.

Speaker 10

Yes, thank you. Just quickly kind of following up on the prior question around the current liabilities management. We noticed the Gavi The update mostly sort of being focused on 2024 in your 10 Q. I'm just curious anything additional On that topic, we should hear beyond the color you provided in Canada and with the Okay. Baio, anything else that could happen on the current liabilities bucket we should be looking out in the near term?

Speaker 10

And then I have a couple of questions.

Speaker 2

Jim, do you want to comment?

Speaker 6

Hey, Will, certainly. And by the way, thank you for asking this question about current liabilities because it is so important to Our financial health as we move forward. When you think about the $864,000,000 that we've eliminate year to date and current liabilities and then the incremental 195 associated with A really important set of agreements with SK Bio. My goodness, what a difference these last months have made As we further strengthen our financial position as a company, we still do have In our, I'll call it, other liabilities, the approximately $700,000,000 associated with Gavi, You have heard us say before that we stand by our position that we in our dispute that We think the claims are unwarranted. And while we can't, as policy speak to legal matters, we did share a disclosure That the arbitration hearing had been scheduled for next July 2024.

Speaker 6

And so that's all we can share at this time. But certainly, going back to, wow, great progress on improving the financial strength of this company and looking

Speaker 10

And then maybe to pull in Philip quickly on the 2 COVID work ongoing. We saw a major antibody effort unfortunately Fair recently and we've had relatively mixed DE results from the mRNA, at least for a particular same subtype. Could you just talk about, Philip, what you're sort of learning in as you think about late stage Execution for your candidate and obviously there are distinct advantages that you have with your combination. How you might be looking to design that Phase 3 study?

Speaker 5

Yes. So first, I want to remind you The data that we presented previously was a relatively small data set, right? We compared 11 different formulations, so those had to be bedside mixes. So the whole idea is for this next study, we're going to be testing a co formulated vaccine, which will be the final co formulated product we're Looking at to develop the safety database, we could actually go into a large Phase 3 study. Now we think we're going to have superior product.

Speaker 5

That's the target product profile, and we aim to with a clinical efficacy Phase 3 study to follow. Now that being said, our stage gated approach is really Release resources to develop the co formulation and looking forward in the future hopefully to get that Phase 2b study taken care of next year To increase the value of the asset and really to have assured us that as we go in a Phase III study, we'll have a superior product.

Speaker 10

Okay, understood. And maybe just one final one for John, if I may. The range this U. S. Product sales guidance range is fairly broad.

Speaker 10

I was just curious in terms of Timing versus market share versus some of the considerations around price and volume levers, How should we characterize some of that based on your customer level discussions? You obviously had it done already with GPOs. Are you able to sort of break down those different variables in terms of how we may fare against that range, which is pretty broad?

Speaker 2

Yes. John T, you want to comment?

Speaker 4

Yes. Hey, Mike. Look, I think you're seeing a pretty significant range of estimates on total U. S. Market demand probably for good reason in that there's a lot of variability in what's going to be driving market sizing for the fall season.

Speaker 4

You had A lot of vaccine fatigue in the last fall season and a lot of good reason for that. People were into their second or third booster. They were getting told to be vaccinated again in the fall campaign. It was falling off the headlines. The U.

Speaker 4

S. Government was declaring victory over the pandemic. I think we're in a different situation in this fall campaign. We have a new strain of the virus circulating. In order to be protected from that new strain or to reduce serious illness from That strain, you need to have this updated vaccine in place.

Speaker 4

In part, what's going to drive that is Information and communication to the consumer and healthcare providers about the need, assistance from the CDC and their communications campaign, Advising the public as to what to expect. And then of course, it's participation at the pharmacy level, right, plays a significant role going forward In supporting vaccination, the office based practitioner engagement with public health, the VFC programs, 317 funds. Remember, there's also the Bridge Access Program that's been talked a lot about with Secretary Becerra to make sure we've got coverage for underinsured, no insured, underserved populations. And so I think we're going to watch this play out over The next few weeks months to decide where that is. As far as our market share is concerned, remember, we had very little participation In the U.

Speaker 4

S. Market last year, unfortunately. And so but we have kind of moderate expectations about what we should be able to do, But I think that there is a demonstrated need for a non mRNA COVID vaccination. They understand the value of our protein based vaccine. We are the only protein based vaccine in the U.

Speaker 4

S. Market, and we're going to be talking about choice And Choice being important to this market. So we expect to see some market share gains in this fall campaign for sure.

Speaker 10

Great. Thanks guys for taking my question. Appreciate it.

Operator

Our next question will come from Alec Stranahan with Bank of America. You may now go ahead.

Speaker 9

Hey guys, thanks for taking our questions. Just a couple from us. First, maybe just a finer point on the expectations around the BLA approval. Is your expectation that going into the fall vaccination cycle that you'll have a BLA in hand? And if not, are any of the contracts deliveries that you expect contingent on a BLA,

Speaker 4

Yes, Alex. Thanks. That's actually a really good question that we want to make sure everybody clearly understands. So, we are already in the process of submitting For the BLA, we expect that to be final submission within the coming weeks months and then a BLA approval in the Q1 of next year. That process does not have a negative or positive effect for the fall campaign, Right.

Speaker 4

Constant coordination and communication with FDA. We expect full operating flexibility under the emergency use authorization. That conversation, as I said, has been taking place with the regulators and with the FDA. And so no restrictions across any of our Distributors, pharmacies, healthcare providers, because we will have that EUA authorization available to this product from the FDA.

Speaker 9

Okay, great. And maybe one quick follow-up, maybe for Philip. Just in terms of The data that goes into the BLA, what the FDA would want to see for full approval, is this simply comparability versus Is the NuvaXimod on immunogenicity or do you need to also demonstrate protection from infection? And if it's the latter, would you be updating the markets once this data is available? Thank you.

Speaker 5

Yes. So Let me be kind of crisp on this. The BLA itself is based on the prototype Seeing 2,373, the original strain. So that's as John said, we have a rolling submission and that's going in now. The approval for EUA for the XBB is also going in.

Speaker 5

As I've said, we've completed the complete clinical role and the data I showed you Today is the key clinical data for authorization of the XPV variant. There's no other data in that file other than the data you saw today. And that's going to be concluded this month with expectation for we'll be building product by the end of September for the CDC FDA. Now there's a subsequent supplemental BLA next year, shall wrap all this up into a single file going forward. So at some point next year, we're going to be out of the EUA game And in a straight BLA game with this and all subsequent variance.

Speaker 5

Great. Thank you.

Operator

Our next question will come from Vernon Bernardino with H. B. Wainwright. You may now go ahead.

Speaker 11

Hi, everyone. Thanks for taking my question and Congrats on the restructuring and positive results on The liabilities. I just wanted to confirm a few things. Just wanted to confirm that the WACC You quoted it was 130 and whether that was for a single dose booster type shot or is that For the full vaccination regimen. And I have a follow-up.

Speaker 11

Thank you.

Speaker 4

So Vernon, that's $130 WACC is $130 per dose regardless of presentation. And so therefore, the calculation is based upon WACC reimbursement follows in line with that calculation and then of course the supporting contracts out to specific healthcare providers It's all part of how that process works.

Speaker 11

And how does that work with, I know Some would consider that's kind of a premium price. How is that and receptivity with A combination COVID and approved vaccine as far as the receptivity to such a vaccine being Some way highly desired and then therefore also something deserving of premium pricing?

Speaker 4

Yes. I don't know that I would call it premium pricing. You're in the prevention or reduction of illness of a significant and severe Disease, so the justification for that is based upon pharmacoeconomic modeling that takes a look at the benefit received from the vaccine Against the economic burden associated with hospitalization, illnesses, out of school, out of work, Etcetera, etcetera. I think we have a calculation that is reviewed. We're confident that there is A robust cost benefit analysis that supports that WACC consistent with the other manufacturers.

Speaker 4

We won't yet comment on where we're going to be pricing strategy for a combo vaccine. But if you do have something based upon the data that we saw from the Phase 2, That immunogenicity is robust and better than the leading vaccine in the market and that you also are combining that with a COVID vaccine That has a robust efficacy profile against a severe disease burden, that you would expect to see pricing consistent With the economic benefit.

Speaker 11

Terrific. Appreciate the additional insight.

Speaker 4

You're welcome.

Operator

This will conclude our question and answer session. I'd like to turn the conference back over to John for any closing remarks.

Speaker 2

Just want to say thank you for joining us today everyone. We appreciate it and we look forward to sharing further updates with you in the future. Have a great day everybody.

Operator

Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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