Q4 2023 Vaxcyte Inc Earnings Call

Operator: https://www.youtube.com Come by, we're about to start. Good afternoon everyone, my name is Operator. At this time, I would like to welcome... Vax. All lines have been placed on mute. Back, now, question-and-answer period. We would like to ask you a question during this time. Just a reminder, today's call is being recorded. Now, at this time, I'll... Guggenheim, President and Chief Financial Officer.

Please standby were about to begin.

Good afternoon, everyone. My name is Beau and I will be your conference operator today at this time I would like to welcome everyone to the backside fourth quarter and full year 2023 financial results Conference call.

All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer period. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question simply press Star two and just a reminder, today's call is being recorded now at this time I'll turn.

Things over to Mr. Andrew Guggenheim, President and Chief Financial Officer of Bauxite. Please go ahead Sir.

Andrew L. Guggenhime: Thank you, Operator, and good afternoon. I'd like to welcome you to Vaxcyte's earnings conference call to discuss our 2023 results and to provide a business update. I am joined today by our Chief Executive Officer, Grant Pickering, and our Executive Vice President and Chief Operating Officer, Jim Walker. Earlier this afternoon, we issued a news release announcing our results; copies of this and our other news, latest corporate presentation, and SEC filings can be found in the investors and media section of our website. Before we begin, I'd like to remind you that during this call, we'll be making certain forward-looking statements about Vaxcyte, which are subject to various risks, uncertainties, and other factors that could cause actual results to differ Please see our press release issued today, as well as our most recent filings with the SBA, including the risk factors set forth in our Form 10-K for the year ended December 31st, 2023 and any subsequent reports filed with the SEC. With that, I'll turn the call over to Grant Pickett. Grant.

Thank you operator, and good afternoon, everyone.

I'd like to welcome you to backstage earnings conference call to discuss our 2023 results and to provide a business update.

I'm joined today by our Chief Executive Officer, Grant, Pickering, and our executive Vice President and Chief operating Officer, Jim lawful.

Earlier. This afternoon, we issued a news release announcing our results.

Copies of this and our other news releases, they just corporate presentation and SEC filings can be found in the investors and media section from that site.

Before we begin I'd like to remind you that during this call we'll be making certain forward looking statements about backside, which are subject to various risks uncertainties and other factors that could cause actual results to differ materially from those referred to in any forward looking statements for a discussion of the risks.

And uncertainty associated with these statements. Please see our press release issued today as well as our most recent filings with the SEC.

Putting the risk factors set forth in our Form 10-K for the year ended December 31st 2023, and any subsequent reports filed with the SEC.

With that I will turn the call over to Greg.

Great.

Grant Pickering: Thanks, Andrew. And all of you on the call and webcast, thank you for joining us today. 2023 was another remarkable year for Vaxcyte, officially marking our 10th year of thoughtful and methodical research and development by the entire Vaxcyte team and our partners. We are driven by our mission to prevent or treat infections caused by bacterial diseases, including invasive pneumococcal disease or IV. This past year, we continued to make significant strides in advancing our potentially best-in-class pneumococcal conjugate vaccines, or PCVs, Vax24, our lead 24-valent candidate, and Vax31, our next-generation 31-valent candidate, and we remain focused on providing the broadest spectrum of coverage against IPD for both adults and children. Last year was highlighted by the successful completion of our Vax24 Adult Phase 2 program.

Thanks, Andrew and all of you on the call and webcast. Thank you for joining us today.

2023 was another remarkable year for box right officially marking our 10th year of thoughtful and methodical research and development by the entire Backsight team and our partners.

We are driven by our mission to prevent or treat infections caused by bacterial diseases, including invasive pneumococcal disease for IPD. This past year, we continued to make significant strides in advancing our potentially best in class pneumococcal conjugate vaccines for Pcbs that 24 hour, leading 24 valent candidate.

And back 31, our next generation 31 day like candidates and we remain focused on providing the broadest spectrum of coverage against IPD for both adults and children.

Last year was highlighted by the successful completion of our backs 24 adult phase III program.

Grant Pickering: Following our stellar initial proof-of-concept data in late 2022 in adults aged 50 to 64, we reported data in April 2023 from a separate Phase 2 study in adults 65 and older that not only confirmed the prior proof-of-concept study results but showed even greater immune responses compared to PREV-NR20 on a relative basis. These data further validate the potential of our cell-free platform and carrier sparing approach to deliver broader-spectrum PC

Following our stellar initial proof of concept data in late 2022 in adults aged 50 64, we've reported data in April 2023 from a separate phase two study in adults 65 and older but not only confirmed the prior proof of concept study results and showed even greater immune responses compared to.

<unk> 20 on a relative basis.

These data further validate the potential of our cell free platform and carrier sparing approach to deliver broader spectrum Pcbs.

Grant Pickering: The findings from our Adult Phase II program support a potential best-in-class profile for Vax24 and demonstrate how our novel, cell-free technology platform has the capability to overcome the limitations of other conventional approaches. These results and the foundation we have carefully created have us well positioned to advance our PCV franchise to potentially disrupt what has consistently been a crucial vaccine class societally and financially. Following the completion of the Vax24 Adult Phase 2 program, we made important progress with regulation. This included a successful end of Phase 2 meeting with the FDA regarding the clinical design of the Vax24 Phase 3 program, as well as encouraging feedback on CMC-related matters as we plan for future potential BLA submissions. In addition to the positive developments for VAX-24, we were pleased to initiate the Adult Clinical Program for VAX-31. With this important step, VAX-31 is now the broadest-spectrum PCV in the country. Following the FDA's acceptance of the adult IND, we initiated the phase one portion of a phase one two study in adults 50 and older in November.

Findings from our adult phase III program supporting the potential best in class profile for <unk> 24, and demonstrate how our novel cell free technology platform has the capability to overcome the limitations of other conventional approaches.

These results and the foundation, we have carefully created have us well positioned to advance our <unk> franchise to potentially disrupt what has consistently been a crucial vaccine class societally and financially.

Following the box 24 adult phase III program completion, we made important progress with regulators. This included a successful end of phase two meeting with the FDA regarding the clinical design for the next 24 phase III program as well as encouraging feedback on CMC related matters as we plan for future.

<unk> BLA submissions.

In addition to the positive developments for <unk> 'twenty four we were pleased to initiate the adult critical program <unk> 31.

With this important step back 31 is now the broadest spectrum PCB in the clinic.

Following the Fda's acceptance of the adult <unk>, we initiated the phase one portion of our phase <unk> study in adults 50 and older in November the <unk>.

Grant Pickering: The strong momentum of this study continued into 2024 as we announced the start of the Phase II portion in early January and completion of enrollment less than a month later. I am incredibly proud of our many achievements, particularly across clinical, regulatory, and manufacturing for our PCV programs, and we now look ahead to several important milestones. For the adult indication, our Vax24 program is Phase III ready, and we are in the final stages of manufacturing the product needed for several of the potential Phase III studies, including the pivotal non-inferiority study. In advance of the potential initiation of this Vax24 study in the second half of this year, we expect to announce the top-line safety, tolerability, and immunogenicity data from our Vax31 Adult Phase 1-2 study in the third quarter.

This study continued into 2024 as we announced the start of the phase II portion in early January.

Completion of enrollment less than a month later.

I'm incredibly proud of our many achievements, particularly across clinical regulatory and manufacturing for our PCB programs and we now look ahead to several important milestones.

For the adult indication our backs 24 programs in phase III and we're in the final stages of manufacturing the product needed for several of the potential phase III studies, including the pivotal non inferiority study.

In advance of the potential initiation of the stocks 24 study in the second half of this year, we expect to announce top line safety Tolerability and Immunogenicity data from our backs 31 adult phase one study in the third quarter.

Grant Pickering: This timing and the overlapping timeline for the completion of the Vax 24 and Vax 31 Adult Phase 3 studies provide us with the opportunity to make a strategic decision regarding which adult program we will move into Phase 3 following the Vax 31 data readout. If we advance fax 24, we intend to initiate the pivotal non-inferiority study in the second half of this year and the balance of the phase three studies, which are shorter in duration than the non-inferiority study, in 2025 and 2026. If we advance Vax 31, we expect to initiate the full complement of the Phase 3 studies in 2025 and 2026. Regardless of which program we move forward with, we expect to initiate the final phase three studies in 2026 and, subject to the results of these studies, submit a BLA shortly following the completion of the last study.

This timing and the overlapping timeline for the completion of the <unk> 24, and <unk> 71 adult phase III studies provide us the opportunity to make a strategic position regarding which adult program will move into phase III. Following the back 31 data readout.

If we advance X 24.

We intend to initiate the pivotal non inferiority study in the second half of this year and the balance of the phase III studies, which are shorter in duration than the non inferiority study in 2025 and 2026 if.

If we advance back 31, we expect to initiate the full complement of the phase III studies in 2025 and 2026 rigs.

Regardless of which programs we move forward, we expect to initiate the final phase III studies in 2026 and subject to the results of these studies submit a BLA shortly following the completion of the last study.

Grant Pickering: Vax24 remains a potential best-in-class candidate, covering more serotypes than any pneumococcal vaccine on the market or in U.S. clinics today, and Vax31 has the potential to further increase coverage to approximately 95% of IPV circulating in the U.S. adult population. Additionally, beyond expanded disease protection, Vax31 is designed to also maintain coverage of previously circulating strains that are currently contained via ongoing research This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn. This puts us in a unique position relative to other sponsors who are applying the conventional PCV approach and are forced to make sacrifices in an attempt to cover newly circulating strains.

That's 24 remains a potential best in class candidate.

Bring more stereotypes than any pneumococcal vaccine on market or in U S. Clinics today and back 31 has the potential to further increase coverage to approximately 95% of IPD circulating in the U S adult population.

Beyond expanded disease protection box 31 is designed to also maintain coverage of previously circulating strains that are currently contained via ongoing vaccination.

This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn.

This puts us in a unique position relative to other sponsors who are applying the conventional PCB approach and are forced to make sacrifices in an attempt to cover newly circulating strains.

Grant Pickering: We estimate that the adult pneumococcal vaccine market today is approximately $2 billion of the total $8 billion annual global market and is positioned to be the fastest-growing strategy. Growth in the U.S. market is expected to accelerate due to the potential shift in universal adult vaccination from age 65 down to 50, which would both expand the market and open up the adult regimen to a prime Boost schedule nearing the infant market. Outside the U.S., we expect to see other countries begin to routinely recommend adult vaccination, as evidenced by the recent recommendation in Germany to vaccinate adults 60 and older.

We estimate that the adult pneumococcal vaccine market today, its approximately $2 billion of the total $8 billion annual global market and is positioned to be the fastest growing segment growth in the U S market is expected to accelerate due to the potential shift in universal adult vaccination from age 65.

It's down to 50, which will both expand the market and open up the adult regimen to a prime boost schedule mirroring the handset market outside the U S. We expect to see other countries begin to routinely recommend adult vaccination as evidenced by the recent recommendation in Germany to vaccinate adults 60.

And older.

Grant Pickering: While the adult market is expected to grow significantly, the infant segment continues to represent the largest portion of the global pneumococcal vaccine market at an estimated $6 billion in sales annually. We believe Vax24 has a potential best-in-class profile for this vital population, and we are thrilled to be nearing the completion of enrollment in the second and final stage of our Vax24 infant phase two study. Based on our progress, we expect top-line data from the primary immunization series by the end of the first quarter of 2025, with top-line booster data to follow by the end of that year. In contrast to the adult program, the Vax 24 infant clinical program is substantially ahead of the Vax 31 infant program, and we intend to advance both of our PCV candidates in this population.

While the adult market is expected to grow significantly the infant segment continues to represent the largest portion of the global pneumococcal vaccine market at an estimated $6 billion in sales annually. We believe Bax 24 has a potential best in class profile for this vital population and we are.

Drilled to be nearing the completion of enrollment in the second and final stage of our backs 24 infant phase III study.

Based on our progress we expect the top line data from the primary immunization series by the end of the first quarter of 2025 with the top line booster data to follow at the end of that year.

In contrast to the adult program. The <unk> 2004, <unk> clinical program is substantially ahead of the backs 31 program and we intend to advance both of our PCB candidates. In this population, we expect to provide guidance on the potential timing for add backs 31 infant indeed, following the readout of the vacs.

Grant Pickering: We expect to provide guidance on the potential timing for a Vax31 infant IND following the readout of the Vax31 Phase 1-2 adult study later this year. Bringing the broadest PCBs to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population and is what drives our efforts every day. Given the magnitude of the opportunity for our PCD franchise, we continue to invest in further solidifying our manufacturing foundation to enable robust, large-scale manufacturing.

31 phase one two adult study later this year.

Bringing the broadest PCB is to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population is what drives our efforts every day.

Given the magnitude of the opportunity of our <unk> franchise, we continued to invest in further solidifying our manufacturing foundation to enable robust large scale manufacturing. These investments are intended to support the potential global commercialization of <unk> for both the adult and infant population.

Grant Pickering: These investments are intended to support the potential global commercialization of our PCDs for both the adult and infant population. Our expanded relationship with Lonza and our decision to exercise our option with Sutro Biopharma, both of which we announced late last year, are reflective of these efforts. In addition to our PCV franchise, we continue to advance our earlier-stage vaccine candidates, including VaxA1 to prevent group-based strep, VaxPG to treat periodontitis, and VaxGI to prevent dysentery and shingleosis. VaxA1 and VaxGi, as well as our PCV programs, target diseases that are significant contributors to antimicrobial resistance, or AMR. AMR poses a serious global health threat, and if no action is taken, drug-resistant diseases are expected by the WHO to be a leading cause of death by 2050.

Our expanded relationship with <unk> and our decision to exercise our option with secure Biopharma, both of which we announced late last year are.

Are reflective of these efforts.

In addition to our PCB franchise, we continue to advance our earlier stage vaccine candidates, including <unk>, one to prevent group a strep <unk> P. G to treat periodontitis and backs Gi to prevent dysentery and shigellosis.

<unk>, one and <unk> Gi as well as our PCB programs target diseases that are significant contributors to anti microbial resistance for ahmar.

Amr's poses a serious global health threat and no action is taken drug resistant diseases are expected by the WH out to be a leading cause of death by 2050, while <unk> is a complex crisis that no single solution will fully address vaccines represent an important part of the solution.

Grant Pickering: While AMR is a complex crisis that no single solution will fully address, vaccines represent an important part of the solution. We are proud to develop vaccines to help fight diseases that have become increasingly resistant to treatment with antibiotics, and we look forward to sharing more updates on our earlier stage pipeline over the course of the year. From a financial perspective, we substantially strengthened our balance, raising approximately $545 million in net proceeds in a follow-on financing last April and then adding another $816 million earlier this month. Pro forma, after this most recent financing, we had over $2 billion in cash and investments as of year end.

We are proud to develop vaccines to help fight diseases that have become increasingly resistant to treatment with antibiotics and we look forward to sharing more updates and our earlier stage pipeline over the course of the year.

From a financial perspective, we substantially strengthened our balance sheet raising approximately $545 million net proceeds in a fire.

Oh on financing last April and then added another $816 million earlier this month.

Pro forma after this most recent financing we had over $2 billion in cash and investments as of year end.

Jim: This financial strength provides us with the capital to fund the company through several important milestones over the next few years, which Andrew will highlight now. I'll now turn it over to Jim, who will provide more details on our PCB programs and strategy.

This financial strength provides us the capital to fund the company through several important milestones over the next few years, which Andrew will highlight later.

Now I'll turn it over to Jim who will provide more details on our PCB programs and strategy Jeff.

Jim: Thanks, Greg. I'd like to start by reiterating why developing broader-coverage vaccines to treat pneumococcal disease matters. Despite the widespread administration of effective vaccines, the global impact of the disease remains significant and is associated with high case fatality rates, antibiotic resistance, and meningitis. In the U.S. alone, the standard-of-care pediatric and adult pneumococcal vaccines cover only approximately 30 to 50 percent of circulating disease.

Thanks Grant.

I'd like to start by reiterating why developing broader coverage vaccines to treat pneumococcal disease matters.

Despite widespread administration of effective vaccine the global impact of disease remains significant and is associated with high case fatality rates antibiotic resistance and James in.

In the U S alone the standard of care pediatric and adult pneumococcal vaccines cover only approximately 30% to 50% of circulating disease.

Jim: As a result, the public health community continues to affirm the need for a broader spectrum of vaccines to prevent IPV. We designed our PCBs to expand coverage and still include all the serotypes covered by the current marketed vaccines that were most prevalent when these vaccines were originally developed. The ability to both add newly circulating strains and maintain pressure on previously circulating strains is critical from a global health perspective.

As a result, the public health community continues to affirm the need for a broader spectrum of vaccines to prevent ITT.

We designed our pcbs to expand coverage and still include all of this year at types covered by the current marketed vaccines that were most prevalent when these vaccines were originally developed.

The ability to both add newly circulating strength and maintain pressure on previously circulating strains is critical from a global health perspective.

Jim: Based on the totality of results from the VAX-24 Adult Phase II program that Grant referred to earlier, we believe we have the opportunity to set a new bar for pneumococcal vaccines by delivering broader coverage and higher immune responses relative to conventional PCV. Following the completion of the Phase 2 Adult Program, we had a successful end of phase 2 meeting with the FDA focused on the Vax24 Adult Phase 3 Clinical Program. We believe there is agreement with the FDA on the clinical design of this program, including the approximate overall number of subjects, the primary and secondary endpoints for the pivotal noninferiority study, as well as confirmation that the planned immunogenicity analyses are sufficient to support licensure, and an efficacy study is therefore not required.

Based on the totality of results from the <unk> 24 adult Phase III program. The grant referred to earlier, we believe we have the opportunity to set a new bar for pneumococcal vaccines by delivering broader coverage and higher immune responses relative to conventional pcbs.

Following the completion of the phase II adult program, we had a successful end to speak to meeting with the FDA focused on the Max 24 adult phase III clinical program.

We believe there is agreement with the FDA on the clinical design of this program, including the approximate overall number of subjects the primary and secondary endpoints for the pivotal non inferiority study as well as confirmation that the planned immunogenicity analyses are sufficient to support licensure and an efficacy study is therefore not required <unk>.

Jim: Regardless of whether we advance Vax24 or Vax36, we expect either phase three program to include up to five studies to support licensure and the broad label. Additionally, as part of the ongoing CMC-focused discussions, we received encouraging input from the FDA regarding the VAX-24 adult licensure requirements. We are afforded this dialogue under the VAX-24 Adult Breakthrough Therapy designation and expect to seek additional CMC-focused input from the FDA as we continue to prepare for an Adult Phase III program for either VAX-24 or VAX-31 and future BLA submissions. For Vax31, we are thrilled to see that our Phase I-II adult study progressed from IND acceptance to enrollment completion in approximately three months. In total, the study enrolled 1,015 adults age 50 and older and is evaluating safety, tolerability, and immunogenicity at three doses, low, middle, and high, compared to PREV-NR20, which I will refer to as PCV20. Similar to the criteria for the Vax24 Adult Phase 2 program, the Vax31 study will compare the obstetrophagocytic activity, or OPA, and IgG responses compared to PCV20 for the 20 stereotypes in common.

As to whether we advanced back 24, or <unk> 31, we expect either phase III program to include up to five studies to support licensure and the broad label.

Additionally, as part of the ongoing CMC focus discussions we received encouraging input from the FDA regarding the vaccine for adult licensure requirements. We are afforded this dialogue under the vaccine for adult breakthrough therapy designation.

<unk> to seek additional CMC focused input from the FDA as we continued to prepare for an adult phase III program for <unk>, 24, or <unk> 31, and future BLA submissions.

<unk> 31, we're thrilled to see that our phase one two adult study progressed from IMD acceptance to enrollment completion in approximately three months in total the study enrolled 1015 adults, aged 50 and older and is evaluating safety Tolerability and immunogenicity at three doses low middle and high.

<unk> compared to <unk>, 20, which I'll refer to as <unk>.

Similar to the criteria for the vaccine for adult Phase II program does that 31 study will compare the <unk> activity or Oprah and IGT responses compared to <unk> 20 for the 20 serotypes in comp.

Jim: And for the 11 serotypes unique to Vax31, the study is evaluating the percentage subject to achieve a four-fold rise in Opatiters, which is the established precedent and a basis for approval. Based on our preclinical data for Vax 31 and the clinical data for Vax 24, particularly the mixed dose arm for both adult phase 2 studies, we are optimistic about the prospects for the Vax 31 data. We called it in the mixed-dose arm from the VAX-24 study. We simulated the amount of carrier protein that is in the VAX-31 middle.

For the 11th Serotypes unique to that 31. The study is evaluating the percent subject to achieve a fourfold rise in <unk>, which is the established precedent and a basis for approval.

Based on our preclinical data for <unk> and the clinical data for Bax, one for particularly the mix does armed for both adult phase III studies, we are optimistic about the prospects for the Dax 31 data.

Recall that in the midst of arm from the <unk> 20, <unk> study, we stimulated the amount of carrier protein that is in the Vac 31 middle dose.

Jim: We believe those immunogenicity results give us a preview of what we might expect for Vax 31. If we see results for Vax31 that are comparable to those from the mixed-dose arms of the Vax24 studies, in which all but three serotypes hit the non-inferiority endpoint, we believe that would be a very positive outcome. Similar to our expectations for Vax24 phase 2 adult programs, for the Vax31 study upcoming readout, our focus is on the OPLA geometric mean ratios for each stereotype rather than the confidence interval. However, because this Phase I-II study will be smaller in size than the Phase III study, you can expect these confidence intervals to be wider. It's very possible that several may cross the 0.59 if you're already fresh.

We believe those immunogenicity results give us a preview of what we might expect for <unk> 31.

Could we see results for <unk> 31 that are comparable to those from least dose arms of the next 24 studies, which all of the three serotypes hit the non inferiority endpoint, we believe that would be a very cognizant of that.

Similar to our expectations for <unk> 2004 Phase III program for the <unk> 31 study upcoming readout. Our focus is on the <unk> geometric mean ratios for each year, rather than the confidence intervals.

Because of this phase one two study will be smaller in size in the phase III study you can expect the confidence intervals to be wider it's.

It's very possible that settlement cross through 0.5, non inferiority threshold.

Yes, the <unk> <unk> six or higher each year, taking this step.

Any prior phase II studies have shown that these ratios are adequate to achieve non inferiority thresholds.

Jim: If the GMRs are 0.6 or higher for each spheroid type in this study, prior phase 3 studies have shown that these ratios are adequate to achieve the non-inferiority threshold. When considering the historical precedentence for broader-spectrum PCV candidates, a focus has been on the important societal benefits of expanding disease protection. With this public health goal in mind, for all prior PCV programs that have been approved, regulatory authorities have accepted generally lower overall immune responses and some missed non-inferiority endpoints versus the standard of care. We believe, however, based on our Vax24 data, that our carrier sparing platform has the potential to change this historical pattern by both extending coverage and maintaining immune responses. With Vax31, we expect to increase disease coverage by 45% over the standard of care in adults today, which is significantly greater than the increase in coverage presented by prior. We believe this level of improvement would be strongly considered by regulators in their assessment of the potential public health benefits FACS 31 may provide.

When considering the historical precedents for broader spectrum PCB candidates. Our focus has been on the important societal benefits of expanding disease protection with.

With this public health goal in mind for all prior PCB programs that have been approved.

<unk> have accepted generally lower overall immune responses and some missed non inferiority endpoints versus the standard of care. We believe however, based on our vaccine for data that our carrier sparing platform has the potential to change this historical pattern by both extending coverage and maintaining immune responses.

The snacks 31, we expect to increase disease coverage by 45 percentage points over the standard of care in adults today, which is significantly greater than the increase in coverage presented by prior approach.

We believe this level of improvement would be strongly considered by regulators and their assessment of the potential public health benefits back 31 may provide.

As an adult programs continue to advance we are also pleased with the progress we've made with our Max 24 program.

<unk> four has a potential best in class profile in this population and we are excited to be nearing enrollment completion for our infant phase III study.

Given the size and global nature of the market. We are particularly excited about the primary booster data readouts expected in 2025.

We believe these milestones along with the back 31 adult data readout expected in the third quarter of this year will further define the full potential and magnitude of the PCB opportunity for vaccine.

We look forward to sharing important updates on the progress of our PCB franchise. This year.

I would now like to turn the call over to Andrew.

Jim: As our adult programs continue to advance, we are also pleased with the progress we have made with our Vax24 program and input. Vax24 has a potential best-in-class profile in this population, and we are excited to be nearing enrollment completion for our infant phase 2 study. Given the size and global nature of the infant market, we are particularly excited about the primary and booster data readouts expected in 2025. We believe these milestones, along with the Vax31 adult data readout expected in the third quarter of this year, will further define the full potential and magnitude of the PCB opportunity for Vax. We look forward to sharing important updates on the progress of our PCB franchise this year, and I would now like to turn the call over to.

Great. Thanks, Jim on.

On the financials with respect to the income statement the details of our fourth quarter and full year 2023 results and the reasons for the variances in the comparable 2022 periods are reflected in our 10-K filing and summarized in our press release.

The year over year increase in R&D expenses was driven primarily by higher manufacturing expenses related to the planned adult phase III clinical trials and potential future commercial launches of our PCB programs.

Both R&D and G&A expenses also grew as we invested in our team to support our recent and anticipated growth.

The acquired manufacturing rights expense of $75 million for the fourth quarter and full year 2023 was related to the exercise of the option in the future of Biopharma of which 50 million was paid in cash in the fourth quarter the.

2022 expense for the same line item was related to the upfront consideration incurred in connection with the original option agreement entered into with Ctrip.

I would also note that the contribution of the interest income line as a function of our higher cash and investment balances and the higher interest rate environment.

Andrew L. Guggenhime: Great. Thanks, Jim. On the financials, with respect to the income statements, the details of our fourth quarter and full year 2023 results and the reasons for the variances to the comparable 2022 periods are reflected in our 10-K filing and summarized in our press release. The year-over-year increase in R&D expenses was driven primarily by higher manufacturing expenses related to the planned adult phase 3 clinical trials and potential future commercial launches of our PCB program. Both R&D and G&A expenses also grew as we invested in our team to support our recent and anticipated growth. The acquired manufacturing rights expense of $75 million for the fourth quarter and full year 2023 was related to the exercise of the option with Sutra Biopharma, of which $50 million was paid in cash in the fourth quarter.

As we look forward, we expect an increase in 2020 for R&D and G&A operating expenses over both full year and Q4 2023 annualized levels, particularly within R&D.

This expected increase is primarily a function of our investment to make the required clinical trial materials for a potential back 24, or <unk> 31 phase III adult program, which will consist of multiple trials and to continue manufacturing activities to support the potential future commercial launches of our PCB programs.

While we expect substantial annual growth of our R&D expenses, we do expect the amount to vary by quarter, depending on timing of manufacturing activities for G&A, we expect the expense growth to be generally steady by quarter.

At this time, we do not anticipate any future acquired manufacturing rights expenses.

Separate from the income statement in the fourth quarter of last year, we commenced construction and build out of the dedicated manufacturing suite at lines to support the potential global commercialization of our <unk> programs in connection with the agreement we entered into with them in October.

Andrew L. Guggenhime: The 2022 expense for the same line item was related to the upfront consideration incurred in connection with the original option agreement entered into with CTRO. I would also note the contribution of the interest income line as a function of our higher cash and investment balances and the higher interest rate environment. As we look forward, we expect an increase in 2024 R&D and G&A operating expenses over both full-year and Q4 2023 annualized levels, particularly within R&D. This expected increase is primarily a function of our investment to make the required clinical trial materials for a potential Vax24 or Vax31 phase 3 adult program, which will consist of multiple trials, and to continue manufacturing activities to support the potential future commercial launches of our PCB program While we expect substantial annual growth in our R&D expenses, we do expect the amount to vary by quarter depending on the timing of manufacturing activity. For GNA, we expect the expense growth to be generally steady by quarter.

We expect this buildout to take approximately two to two and a half years at a capital cost over this period of approximately $300 million to $350 million.

As of year end 2023, we had incurred $86 5 million of capital and facility Buildout expenditures that were reflected on our balance sheet in two separate line items property and equipment and other assets.

The detailed breakdown can be found in our 10-K filed today.

For the remaining construction and build out cost of this dedicated manufacturing suite. We expect the majority will be incurred in 2024 and the balance in 2025, perhaps into early 2026.

Most of the associated costs will be reflected on our balance sheet in the same two line items I mentioned earlier and will not run through the income statements and some buildup of the sweep is complete and manufacturing activities commence.

There will be a separate and smaller operating expense component over the build out period that will be reflected within R&D expenses.

Turning to the balance sheet and cash runway as Brent noted, we continued to maintain a strong financial position and then in 2023 with $1 4 billion with cash cash equivalents and investments. This excludes the $816 5 million in net proceeds from the follow on offering we completed early.

Andrew L. Guggenhime: At this time, we do not anticipate any future acquired manufacturing rights expenses. Separately from the income statements, in the fourth quarter of last year, we commenced construction and build out of the dedicated manufacturing suite at Lonza to support the potential global commercialization of our PTV programs in connection with the agreement we entered into with them in October. We expect this buildup to take approximately two to two and a half years at a capital cost over this period of approximately $300 to $350 million. As of year-end 2023, we had incurred $86.5 million of capital and facility build-out expenditures that were reflected on our balance sheet in two separate line items. Properties and Equipment, and other apps.

Earlier this month.

Okay.

Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through a number of important milestones over the next few years.

Moving the back 31 adult phase one two study top line data expected in the third quarter of this year.

The <unk> 2004 infant phase III study primary series and booster dose readout expected by the end of the first quarter and year end 2025, respectively.

The initiation of anticipated phase III studies for the adults PCV program, we elect to advance.

Shift back to 'twenty four but includes a non inferiority study in the second half of this year and the remaining steady in 2025, and 2026 or <unk> 31, a full complement of studies in 2025 and in 2026.

Andrew L. Guggenhime: The detailed breakdown can be found in our 10-K file today. For the remaining construction and build-out costs of this dedicated manufacturing suite, we expect the majority will be incurred in 2024 and the balance in 2025 and perhaps into early 2026. Most of the associated costs will be reflected on our balance sheet in the same two line items I mentioned earlier and will not run through the income statements until the buildup of the suite is complete and manufacturing activities commence. There will be a separate and smaller operating expense component over the build-out period that will be reflected within the R&D expense. Turning to the balance sheet and cash runway, as Grant noted, we continue to maintain a strong financial position, ending 2023 with $1.24 billion in cash, cash equivalents, and investments. This excludes the $816.5 million in net proceeds from the follow-on offering we completed earlier this month.

We expect topline data from the phase III pivotal non inferiority study.

<unk> four or <unk> 31.

And the expected completion of the build out of the dedicated manufacturing suite to support the long term commercialization of our PCB programs.

I will now turn it over to Greg for closing remarks. Thanks.

Thanks, Andrew before moving to Q&A I would like to acknowledge the entire site and our partners' 2023 was an extraordinary year of validation for <unk> 24, and our pipeline over the next year, we look forward to several upcoming catalysts that will further define the profiles of our PCB franchise and I am confident in our ability to exit.

And further scale our business in 2024 and beyond.

We look forward to sharing further updates as the year progresses and appreciate your interest by joining us today with that let's take some questions operator.

Andrew L. Guggenhime: Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through a number of important milestones over the next few years, including the Vax 31 Adult Phase 1-2 Study top-line data expected in the third quarter of this year, and the Vax24 Infant Phase 2 Study Primary Series and Booster Dose Readout expected by the end of the first quarter and year-end 2025 or so. The initiation of anticipated Phase 3 studies for the Adult PTD program we elect to advance, which if Act 24 would include the non-inferiority study in the second half of this year and the remaining studies in 2025 and 2026, or in FACTS 31, the full complement of studies in 2025 and 2026, the expected top line data from the phase three pivotal non-inferiority studies. Advanced Vax 24 or Vax 31, and I will now turn it over to Grant for his closing remarks. Thanks, DeAndre.

Thank you very much Mr. Pickering, ladies and gentlemen at this time, if you do wish to ask a question for todays question and answer period, you'll need to press star one on your telephone keypad you find your question has been answered and you wish to remove yourself from the queue. Please press star two if you are using a speakerphone. Please pick up your handset to allow for optimal sound quality.

Also we ask that you please limit yourself to one question and one follow up question we.

We will go first this afternoon to Jason <unk> of Bank of America.

Oh, Hey, guys. Thanks for taking my questions.

I guess, firstly, just as we think about this decision between 31, <unk> 31 and 24.

Youre ultimately measuring yourself against back 24. So wondering if you can kind of frame what success looks like in.

Indiana would showing kind of like a net incremental coverage of three or four strains as measured by statistical ni or good enough point estimates are or a fourfold rise collectively across the spectrum does that sound like to you kind of what the bar for success looks like and then.

Secondly have you guys explored ways to reduce pretty carrier in the 31.

Grant Pickering: Before moving to Q&A, I would like to acknowledge the entire team at Vaxcyte and our partners. 2023 was an extraordinary year of validation for Vax24 and our pipeline. Over the next year, we look forward to several upcoming catalysts that will further define the profiles of our PCB franchise, and I am confident in our ability to execute and further scale our business in 2024 and beyond. We look forward to sharing further updates as the year progresses and appreciate your interest by joining us today. With that, let's take ask some questions. Operator?

Mainland approach and the reason I ask is for some reason if this iteration of <unk> 31 doesn't make the cut off just wondering.

If there are ways to potentially go back to the drawing board and to optimize thanks.

Yeah.

Yes, Jason Thank you for the question.

So yes, as we look forward to that data that we expect to see in the third quarter.

I mean, we're quite optimistic.

The way we're looking at this program is a combination of the empiric evidence generated to date combined with the circumstances. So from an empirical data perspective.

We have not only of course compelling preclinical data with <unk> 31, but also the tax 24 data that's been generated.

Operator: Thank you very much, Mr. Pickering. Ladies and gentlemen, at this time, if you do wish to ask a question for today's program, you will need to press star 1. You can find your question has been answered from the queue; please press start. If you are using a speakerphone, please pick up your handset to allow for optimal sound quality.

Across the phase III program, that's read out already with a particular emphasis on that next dose cohort, where we were able to already test the cumulative accumulative amount of protein carrier that we would expect.

We had put into the clinic with <unk> 31, so for US we're really looking as you point out a couple of different endpoints. So theres the non inferiority comparisons to <unk> or 'twenty across those 20, <unk> and then there are the incremental 11, where it said slightly.

Jason Gerberi: Also, we ask... We'll go first this afternoon to Jason Gerberi of Bank. Oh, hey guys. Thanks for taking my question. You know, I guess, firstly, just as we think about this decision between 31 and 24, back to 31 and 24. You're ultimately measuring yourself against Vax24, so wondering if you can kind of frame what success looks like and, you know, in the end, showing kind of like a net incremental coverage of three or four strains as measured by statistical NI or good enough point estimates or a four-fold rise collectively across the spectrum. Does that sound like to you kind of what a bar for success looks like? And then, secondly, have you guys explored ways And the reason I ask is, you know, for some reason, if this iteration of X31 doesn't make the cutoff, just wondering if there are ways to potentially go back to the drawing board and optimize. Yeah, Jason.

Different endpoint, where youre looking at fourfold rise over baseline so for us the data that we generated with that backs 24 cohort.

Demonstrated even at that mixed dose level really good comparative.

Results across the 20 that are in <unk> and then the incremental 11.

Set four have already read out the next seven will come with this study and so yes.

Yes for us.

I think we're feeling good the data is going to be here in the not too distant future and.

As you mentioned the <unk>.

Adjusting the ratio that is certainly something that has been at our disposal historically.

We do have a.

A level of precision with our chemistry that permits us to adjust the ratio of sugar to protein in ways that we don't believe anyone else can we've used that to great effect to date with greater sugar than protein than convention, our carrier sparing conjugates, but for the foreseeable future. We don't think we need to go back to the drawing board on that.

Grant Pickering: Thank you for the question. So, yeah, as we look forward to that data that we expect to see in the third quarter, I mean, we're, we're quite optimistic about the way we're looking at this program as a combination of the empiric evidence generated today combined with the circumstances. So, from an empirical data perspective, certainly, we have not only, of course, compelling preclinical data with Vax 31, but also the Vax 24 data that's been generated across the Phase 2 program that's read out already, with a particular emphasis on that mixed-dose cohort where we were able to already test the cumulative amount of protein carrier that we would expect to have put into the clinic with Vax 31. So, for us, you know, we're really looking, as you point out, at a couple different endpoints.

That would be something we could always look at down the road for US we've been able to show that adjustments in dose yield improved immune responses. So the first order if necessary would be more likely to come in the form of adjusted doses, but again as you know Jason This is not.

Perfection.

We acquired the whole.

<unk>.

Focus of this class.

Has been to preserve coverage over historically circulating strains, while looking to expand coverage to newly circulating strains and in that trade. It's been recognized that even with lower immune responses. That's an okay trade off.

Grant Pickering: So, there are the non-inferiority comparisons to Prevnar 20 across those 20 conjugates, and then there are the incremental 11 where it's a slightly different endpoint where you're looking at a four-fold rise over baseline. So, for us, you know, the data that we generated with that Vax 24 cohort demonstrated, even at that mixed-dose level, really good comparative results across the 20 that are in Prevnar 20, and then the incremental 11, you know, four I've already read out, the next seven will come with this study. Yeah, for us, I think, you know, we're feeling good.

Fortunately for us at least <unk> 24, we didnt look like that was going to be required to push coverage. We will see what the back 31 data looks like but I guess the point is perfection is not their requirements. We've seen a few myths strains be considered a good trade off at least in the eyes of the regulators and I think ultimately that's been a good decision and we will see.

What data comes out of this study in the third quarter.

Great. Thanks, so much.

Thank you well go next now to Roger song at Jefferies.

Great Congrats for the progress a few questions from us.

Grant Pickering: The data is going to be here in the not-too-distant future. And, you know, as you mentioned, the idea of adjusting the ratio, that is certainly something that has been at our disposal historically. We do have a level of precision with our chemistry that permits us to adjust the ratio of sugar to protein in ways that we don't believe anyone else can.

Yes, maybe to two so the first one is.

With this 31 data in the Q you probably need another end of phase two meeting with the FDA. The question is how much you can leverage from your 24 end of phase II meeting package.

Grant Pickering: We've used that to great effect to date with greater sugar than protein than convention, a la the carrier sparing conjugates. But for the foreseeable future, we don't think we need to go back to the drawing board on that. But that would be something we could always look at down the road. For us, we've been able to show that adjustments in dose yield improved immune responses. So the first order, if necessary, would be more likely to come in the form of adjusted doses. But again, as you know, Jason, this is not perfection that's required.

Q4 that meeting because you have timeline is basically you're going to start a phase III in 2020 science on unit four attorneys mistakes. If you move forward with necessarily want particularly around the CMC because that's something seems.

Holding you back for the 24 at this moment. Thank you.

Yeah.

Thanks, Roger This is Jim Wassail.

I'll try and answer that question for you I think you're very perceptive in your question.

We're hoping to leverage a lot of the study designs that we proposed to put forward our end of phase II design for <unk> 24.

Grant Pickering: The whole, you know, focus of this class has been to preserve coverage over historically circulating strains while looking to expand coverage to newly circulating strains. And in that trade, it's been recognized that even with lower immune responses, that's an okay tradeoff. Fortunately, for us, at least for Vax24, it didn't look like that was going to be required to push coverage.

And used a very similar design for <unk> 31.

Obviously, we will look at the data from the phase one two of <unk> 31, we'll do a re analysis from a statistical perspective will power. The studies appropriately to ensure that we maximize the probability of success in our non inferiority study and our other phase III studies.

But essentially.

The proposal that we put forward and back 24 will be very similar in terms of the overall study design that we will see for 30 months.

Grant Pickering: We'll see what the Vax31 data looks like, but I guess the point is perfection's not the requirement. We've seen, you know, a few missed strains be considered a good tradeoff, at least in the eyes of the regulators, and I think ultimately that's been a good decision, and we'll see what data comes out of this study in the third quarter. Great, thanks so much. Thank you. We go next now to Roger Song.

Got it and how about the CMC portion of them necessarily one.

Yes.

Save the same thing as well.

We're using very similar manufacturing processes is not exact manufacturing processes in some cases between.

The 24, polysaccharides 31, as well as the drug substance.

Of course, the carrier protein is still the same carrier protein. So a lot of similarities between 24 to 31, so whatever we learn from feedback from the FDA from a CMC perspective from 'twenty four we believes the applicable to 31 as well.

Roger Song: Great. Congratulations on the progress. A few questions from us. Yeah, limited to

Jim: So the first one is, you know, with the 31 data points in 3Q, you probably need another end-of-phase meeting with the FDA. The question is how much you can leverage from your 24 end-of-phase meeting package for that meeting because your timeline is basically you're going to start phase 3 in 2025 and 2024, 2026 if you move forward with 31, particularly around the CMC because that's something that seems to be, you know, holding you back for the 24 at this moment. Thank you. Thanks, Roger.

<unk>, maybe just a follow up question for the 31 higher dose.

On the call the mixed dose from 'twenty four is mimicking the middle dose for 31.

Maybe just any color you can provide related to the high dose for <unk> 31.

Particularly in terms of the carrier protein how much higher end.

What are the key serotypes potentially they can be dosed higher.

Can give us some color around that thank you.

Yeah, Hey, Roger Grant again.

Yes, we've been a little bit more coy with regard to the doses, we did provide a bit more detail here just for competitive purposes, but we want to make sure that we come out of this phase II experiment with a clear dose to advance to phase III, So ergo, the bracketing with lower and higher doses.

Jim: This is Jim Wassel, and I'll try and answer that question for you. I think you're very perceptive in your question. We're hoping to leverage a lot of the study designs that we proposed to put forward with our end-of-phase 2 design for Vax24 and use a very similar design for Vax31. Obviously, we'll look at the data from Phase 1-2 of VAX 31. We'll do a reanalysis from a statistical perspective.

Haven't gotten into explicit detail, but there is a pretty tight window dosing that spend historically applied in the pneumococcal conjugate vaccine space. So we wouldn't do anything that would be radical there, but we're not going to go into.

The explicit details of what those are at least for the time being and that will be decided at the time, we review the data.

Jim: We'll power the studies appropriately to ensure that we maximize the probability of success in our non-inferiority study and our other Phase 3 studies. But essentially, the proposal that we put forward in VAX 24 will be very similar in terms of the overall study design that we'll see for 31.

Understood. Thank you. Thank you for taking the question.

Of course.

Thank you well go next now to Celine <unk> at Mizuho.

Hey, guys. This is Eric lamington on for Celine. Thanks.

Thanks for taking our question.

I'm curious what your take on possible outcomes for discussions for VB $100 six at the upcoming ACC Sydney might read through to either your decision between <unk> 24, and <unk> 31.

Jim: How about the CMC portion of the 31? Yes, same thing as well. We're using very similar manufacturing processes, if not exact manufacturing processes in some cases between the 24 polysaccharides and 31 as well as the drug substance. And of course, you know, the carrier protein is still the same carrier protein. So there are a lot of similarities between 24 and 31.

And what it might mean for the compare starwood.

In the phase III. Thank you.

Okay.

Thanks, Eric Jim Wilson again.

So.

I'll answer that by saying.

Think many of US know already at February 29th ACI P. B.

One six will be on the agenda.

Grant Pickering: So whatever we learn from feedback from the FDA from a CMC perspective from 24 is, we believe, applicable to 31 as well. Accents, maybe just a follow-up question for the 31 higher dose. You mentioned on the call that the mixed dose from the SIR-24 is mimicking the middle dose for 31. Maybe just any color you can provide related to the high dose for 31, particularly in terms of the carrier protein, how much higher, and what are the key serotypes potentially could be those higher if you can give us some color around that. Thank you. Yeah, hey Roger and Grant again.

At that meeting, we will get a better idea of the current thinking of the ACP Pneumococcal working group.

The pneumococcal working group.

Most likely present epidemiological data health economic data as being one six clinical data and then they'll make a proposal to the ACI P regarding how to recommend being one six assuming they get FDA approval.

I don't think I'd want to speculate on this especially since we've got it going to have much better idea of by the end of this week with the ACI piece position will be.

I'll say that.

Grant Pickering: Yeah, we've been a little bit more coy with regard to the doses, but we did provide a bit more detail here just for competitive purposes. But, you know, we want to make sure that we come out of this phase two experiment with a clear dose to advance to phase three. Thus, the bracketing with lower and higher doses. We haven't gotten into explicit detail, but there's a pretty tight window of dosing that's been historically applied in the pneumococcal conjugate vaccine space. So, we wouldn't do anything that would be radical there, but we're not going to go into the explicit details of what those are, at least for the time being, and that will be decided at the time we review the data. understood.

<unk> is only applicable in the adult population and it takes a different approach than our PCV program in order for them to reach 21 strain due to the limitations of their technology and to remove nine strains that have been traditionally included an approved PCB. So is that 31, we do have a potential to <unk>.

Further increased coverage to approximately 95% of invasive disease, and we're doing this by adding additional strength and maintaining coverage of previously circulating strains. So we'll wait and see we'll see what the outcomes are.

I think 24 will have a strong position, regardless, obviously 31, which contains.

For the most part all the strength in both vaccines.

We'll be in a strong position.

Grant Pickering: Thank you. Thank you for taking the question. Of course. Thank you. We go next now to Salim Syed at, Hey guys, this is Eric Laddington on behalf of Celene.

To increase coverage and really take a strong position if it gets approved.

Got it thank you.

Thank you well go next now to Dave Risinger at Leerink partners.

Yes, thanks very much.

Eric Laddington: Thanks for taking our question. I'm curious what your take on possible outcomes for discussions about V116 at the upcoming ACIP meeting might read through to, you know, either your decision between Vax24 and Vax31 and what it might mean for the comparison arm, and safe, and Thanks, Eric. Jim Wessel again.

So first I wanted to say congrats on our corporate progress.

I appreciate the updates.

I have two questions for grants and Jim first.

A CIP preferred.

Recommendations are rare, but fact site could be particularly well positioned for a potential preferential recommendation for <unk> 31 could you just comment on that notion and provide your perspectives and then second could you elaborate more Jim on your <unk>.

Jim: You know, so I'll answer this by saying, you know, I think many of us know already that on February 29th, ACIP Merck's V116 will be on the agenda. I think at that meeting, we'll get a better idea of the current thinking of the ACIP pneumococcal working group. The pneumococcal working group will most likely present epidemiological data, health economic data, and V116 clinical data, and then they'll make a proposal to the ACIP regarding how to recommend V116, assuming they get FDA approval.

Comment about.

Potential prime boost opportunity in adults thanks very much.

Yes, thanks for that Dave I appreciate the acknowledgement and Jim is kind of our.

ACI peak Guru, So why don't I hand, it to Jim and see if he can respond to that question.

Yes so.

Okay.

Well, let me jump it so yes.

The ACI has within its purview of the right to extend preferred recommendation they have been limited in those decisions in the past. The most recent of course, which was <unk> over zostavax the shingles vaccines.

Jim: So I don't think I'd want to speculate on this, especially since we've got to have a much better idea by the end of this week what the ACIP's position will be. But I will say that, you know, I want to highlight V116 is only applicable to the adult population, and it takes a different approach than our PCV program. In order for them to reach 21 strains, due to the limitations of their technology, they had to remove nine strains that have traditionally been included in approved PCVs.

It's been more limited in the pneumococcal conjugate vaccine space.

But it does occur.

And we even see that with <unk> in certain circumstances. So.

There are a lot of pundits out there Dave speculating on how the CIP is going to react and the margin of improvement does need to be quite material from an efficacy perspective or coverage perspective, but.

Jim: So with Vax31, we do have the potential to further increase coverage to approximately 95% of invasive diseases, and we're doing this by adding additional strains and maintaining coverage of previously circulating strains. So we'll wait and see. We'll see what the outcomes are. I think 24 will have a strong position regardless.

When you have an opportunity to potentially extend the coverage with a singular vaccine to as high as 95%, while continuing to maintain pressure on previously circulating strains.

Us.

<unk>, we think that is the kind of profile that would warrant a preferred recommendation. So we'll have our day if things stay on track, we will see how they react to that would be 116 profile, but certainly from our perspective.

Jim: Obviously, 31, which contains, for the most part, all the strains in both vaccines, will be in a strong position to increase coverage and really take a strong position if it gets approved. Thank you. Thank you. We go next now to Dave Reisinger at, Yes, thanks very much, uh... so first I want to say congrats on the corporate progress, uh... and uh... appreciate the update. I guess I have two questions for Grant and Jim first. ACIP preferred recommendations are rare, but Vaxcyte could be particularly well positioned for a potential preferential recommendation for Vax 31. Could you just comment on that notion and provide your perspectives? And then, second, could you elaborate more, Jim, on your comment about the potential prime boost opportunity in adults? Thanks very much.

We believe there is that possibility for us Ben B with 116 will be another data point I think what we had heard was there was.

Hope at Merck that there was going to be an opportunity for a preferred recommendation. We will find out I think that's been walked back a bit from what we're reading, but as Jim pointed out.

For the week is out we will have.

A leading indicator.

In terms of your question on the prime boost.

In previous discussions at the ACI when both the 15 Valent 20 Valent got approved there was a debate over whether we should start immunizing starting at 50 years of agents than the current recommendation 65.

I think there is a lot of support for that and the reason is the data says that almost the third probably around 28% to 30% of adults right now are in an at risk category or high risk category forgetting pneumococcal disease.

Dave Reisinger: Yeah, thanks for that, Dave. I appreciate the acknowledgements. And Jim is kind of our ACIP guru, so why don't I hand it to Jim and see if he can respond to that question? Yeah, so, um, Well, I, let me jump in.

And particularly in pneumococcal pneumonia.

And these are groups that it's not just <unk> and malignancies and HIV is very neat.

Jim: So, certainly, the ACIP has within its purview the right to extend a preferred recommendation. However, they have been limited in those decisions in the past. The most recent, of course, was with Shingrix over Zostavax for the shingles vaccine. It's been more limited in the pneumococcal conjugate vaccine space, but it does occur. And we even see that with Prevnar 20 in certain circumstances. So, there are a lot of pundits out there, Dave, speculating on how the ACIP is going to react.

Suppressing. These are these are a lot more common groups.

Severe asthma.

COPD diabetes clinical and chronic liver disease and the belief is that that population in terms of percentage in that age group is only going to grow.

And historically at risk recommendations hadn't really gotten penetration so.

There's been some debate about moving recommendation of 50, and then that would mean most likely that you would need to get a booster in 65, so there could be a prime at 50 and a boost in 65 and we will also see some of that debate I think coming up in the upcoming peak.

Jim: And the margin of improvement does need to be quite material from an efficacy perspective or coverage perspective. But when you have an opportunity to potentially extend the coverage with a singular vaccine to as high as 95% while continuing to maintain pressure on previously circulating strains, objectively, we think that is the kind of profile that would warrant a preferred recommendation. So we'll have our day.

That's great and just a follow up if I may.

Could you talk about your phase III plans in adults.

And your age strategy.

Well from a from an FDA licensure perspective, the adult label is usually extended at age 18 and up so we won't be looking for the same sort of broad label Thats been obtained with other pneumococcal conjugate vaccines. So the next.

Look that is that the ACI PFS to how they grant the universal recommendation, but from a licensure perspective, we'll be looking to have it across the spectrum sort of indication, but then it's a question.

Jim: If things stay on track, we'll see how they react to the B116 profile. But certainly, from our perspective, we believe there is that possibility for us. But B116 will be another data point. I think what we had heard was that there was hope at Merck that there was going to be an opportunity for a preferred recommendation. We'll find out.

Usage and as Jim said, when it's universally recommended the uptake is much greater than what it is restricted to at risk population and I would only add that given the interest in these at risk groups in 50% to 65 year olds, we will make sure to have adequate enrolled at risk groups in our clinical studies.

Jim: I think that's being walked back a bit from what we're reading, but as Jim pointed out, before the week is out, we'll have a leading indicator. In terms of your question on the prime boost, uh, in previous discussions at the ACIP when both the 15-valent and 20-valent got approved, there was a debate over whether we should start immunizing starting at 50 years of age instead of the current recommendation of 65. I think there's a lot of support for that. And the reason is that the data says that almost a third, probably around 28 to 30% of adults right now are in an at-risk category or a high-risk category for getting pneumococcal pneumonia. And these are groups that, you know, it's not just asplenics and malignancies and HIV and severe immunosuppression. These are a lot more common groups. You have, you know, severe asthma, COPD, you have diabetes, chronic pulmonary, and chronic liver disease.

We can support.

He does want to move down to 50 years of age clinical data to help with their decision.

That's super helpful. Thanks, so much.

Thanks, Dave Thank you Lee.

Thank you well go next now to armor rapid at Evercore.

Hi, guys. Thanks for taking my question.

Among the new serotypes, Youre, adding <unk> 31, there's one in particular, which has a bunch of literature on its suggesting it's very unique and perhaps difficult to manufacture I'm, referring to <unk> 35, B can you speak to your confidence in.

The manufacturing as well as early.

And as you saw in preclinical models on 35 B in particular.

Secondly is it your expectation that pfizer's.

Broader spectrum program 'twenty four 'twenty five island.

<unk> is using a second carrier protein beyond Kremlin 97, Thank you.

Jim: And the belief is that the population, in terms of the percentage in that age group, is only going to grow, and historically, at-risk recommendations haven't really gotten through. So there's been some debate about moving the recommendation down to 50. And then that would mean, most likely, that you would need to get a booster at 65. So there could be a prime at 50 and a boost at 65. And we'll also see some of that debate, I think, coming up in the upcoming weeks. That's great.

Yes, maybe I'll answer the second one first and then Jim will address the 35 B question Omar. Thanks. Thank you for both of Us.

So.

Yeah.

The Pfizer.

Yeah.

As it relates to the fourth generation program, yes. It is.

It's hard to know exactly what they're doing so from what they've been willing to disclose they've had they've been considering all number of potential changes to.

To try to extend beyond 20, valent vaccine, but at the most recent earnings results. They seem to indicate that whatever incremental strains would be layered on top of what would presumably be the 20 strains that are in <unk> or 'twenty and there. It then comes down to is it.

Jim: And just to follow up, if I may, could you talk about your Phase 3 plans for adults and your age strategy? Well, from an FDA licensure perspective, the adult label is usually extended at age 18 and up. So we'll be looking for the same sort of broad label that's been obtained with other pneumococcal conjugate vaccines. So the next look then is at the ACIP as to how they grant the universal recommendation. But from a licensure perspective, we'll be looking to have an indication across the spectrum. But then it's a question of usage.

A unique protein carriers at different chemistry is a different linker or some sort of other formulation, but it's hard to know beyond that I don't think they've gotten detailed with regard to that that said.

This idea that notion of using an additional protein carrier that's something other sponsors have tried going back to Gsk's first foray in pneumococcal conjugate vaccines and then more recently with sono fees approach intermingling, if theory of toxin and tetanus toxoid in those.

Jim: And as Jim said, when it's universally recommended, the uptake is much greater than when it's restricted to the at-risk population. And I'd only add that given the interest in these at-risk groups in 15 to 65-year-olds, we'll make sure to have adequate enrolled at-risk groups in our clinical studies so that we can support if the ACIP does want to move down to 50 years of age, using clinical data to help with this. That's super helpful. Thanks so much.

Turned out to be a bit problematic.

Sanofi is not decided to proceed in the adult indication so it's unclear at the moment, but.

Irma Raffitt: Thank you. Thank you. We go next to Irma Raffitt at Everett.

Other attempts in a similar vein haven't worked out, particularly well, but we couldn't say for sure. If that's the approach they are trying as of yet and as to 35 being Jim do you want to comment.

Jim: Hi guys, thanks for taking my question. Among the new serotypes you're adding to Vax31, there's one in particular which has a lot of literature on it suggesting it's very unique and perhaps difficult to manufacture. I'm referring to 35B. Can you speak to your confidence in the manufacturing as well as early immunogenicity that you saw in preclinical models for 35B in particular? Secondly, is it your expectation that Pfizer's broader spectrum program, 24, 25 valent, is using a second carrier protein beyond CREM197? Thank you. Yeah, maybe I'll answer the second one first, and then Jim will address the 35B question. Thank you, for both of us.

Well I mean traditionally we limit our comments on some of this due to proprietary issues.

I'll say 35 as an important serotypes.

One of the more common circulating strains in adults and its probably the most significant contributor to otitis media in the U S. Today.

Are very keen on making sure that it is manufactured appropriately in that it works well in fact 31.

Thank you.

Thank you Mark.

Thank you the next now to Siemens Fernandez at Guggenheim.

Oh, great. Thanks for the question. So I wanted to just talk a little bit about pediatric.

And.

What expectations.

How you'd like to kind of set expectations for the three dose data.

Grant Pickering: So, uh, and Pfizer. Oh, yeah. As it relates to the fourth generation program, yeah, Umar, it's hard to know exactly what they're doing. So, you know, from what they've been willing to disclose, they've been considering all number of potential changes to try to extend beyond a 20-valent vaccine. But in the most recent earnings results, they seem to indicate that whatever incremental strains would be layered on top of what would presumably be the 20 strains that are in PREV-NR20. And then it comes down to, is it a unique protein carrier, is it different chemistry, is it different linkers, or some sort of other formulation? But it's hard to know beyond that.

I know that that is something that Merck has sort of pitched as part of the vaccine event story just interested to know I know that breadth is likely to dominate but three dose regimen has been quite successful overseas. So interested you just know how you guys are thinking about the opportunity for actually perhaps.

A superior profile at all.

Your third dose versus the <unk>, 23rd dose just because a number of those serotypes appeared to Miss.

At three doses and then really required the fourth dose to catch up so just interested to know how youre thinking about that and its importance from a market perspective longer term and then just a second question is on whether you choose $24 31 in the adult vaccination program.

Grant Pickering: I don't think they've gotten very detailed with regard to that. That said, this idea of the notion of using an additional protein carrier is something other sponsors have tried going back to GSK's first foray into pneumococcal conjugate vaccines and then more recently with Sanofi's approach intermingling diphtheria toxin and tetanus toxoid. And those have, you know, turned out to be a bit problematic as, you know, Sanofi hasn't decided to proceed with the adult indication. So, it's unclear at the moment, but other attempts in a similar vein haven't worked out particularly well. But we can't say for sure if that's the approach they're trying as of yet. And as to 35B, Jim, do you want to comment? Traditionally, we limit our comments on some of this due to proprietary issues, but I'll say 35B is an important stereotype.

Are you confident that you won't be required.

Two study versus <unk>.

116.

Or is that something that could be decided after the ACP recommendation in June thanks.

Yeah.

Yes. Thanks for the question Seamus so yeah as it relates to the infant indication, obviously, a critical part of the market.

Three quarters of the sales consistently in that space and.

As you referred to a three dose series I wasn't sure exactly which direction you were until you expanded a bit but yes, so to be clear in the U S. We have a three plus one.

Approach so three vaccinations within the first six months of life Thats called the primary series and then the fourth dose comes in the form of a boost next year in Europe. They restrict that primary series to only two vaccinations and then the third dose. The next year. So it's really a three in Europe versus four dose approach.

Jim: It's one of the more common circulating strains in adults, and it's probably the most significant contributor to otitis media in the U.S. today. So they are very keen on making sure that it is manufactured appropriately and that it works well in Vax30. Thank you. Thank you. We go next now to Simas Fernandez at Google.

Simas Fernandez: Oh, great. Thanks for the question. So I wanted to just talk a little bit about pediatrics and, you know, what expectations you'd like to kind of set expectations for the three-dose data. You know, I know that that is something that Merck has, you know, sort of pitched as part of the vaccine advance story. Just interested to know, I know that breadth is likely to dominate, but a three-dose regimen has been quite successful overseas. So interested to just know how you guys are thinking about the opportunity for actually perhaps a superior profile at your third dose versus the Prevnar 20 third dose just because a number of those serotypes appeared to miss at three doses and then really required the fourth dose to catch up.

And.

As you say less doses create more pressure on lower immune responses and so when when Pfizer studied <unk> in infants in U S and Europe the impact of the one less dose was quite profound and so in the U S.

There were six of the Cerro types that missed the non inferiority comparison to <unk> 13 after the primary series.

And one can imagine that when you only give two vaccinations with a vaccine that's providing lower immune responses the impact of that would be felt in a fewer vaccination approach ensuring up the results of their phase III study in Europe had 11 of the common serotypes missed the non inferiority compares.

And that's the primary series so that that has been a big question Mark.

Simas Fernandez: So just interested to know how you're thinking about that and its importance from a market perspective in the longer term. And then just a second question is on whether you choose 24 or 31 in the adult vaccination program. Are you confident that you won't be required to study versus V116 or is that something that could be decided after the ACIP recommendation in June? Thanks.

Nonetheless, the <unk> in Europe did recently recommended that pregnant 20 ought to be approved so that will be interesting to see how that plays out with that meant that many missed non inferiority comparisons but.

To your point.

What we've seen at least in adults with <unk> 24 data is that we are for the most part getting higher immune responses relative to <unk> and if thats. The case it could widen the advantage certainly in a three dose regimen versus a four dose regimen. So yes, we will have to see how some of this plays out.

Grant Pickering: Yeah, thanks for the question, Seamus. As it relates to the infant indication, obviously a critical part of the market, you know, three quarters of the sales consistently in that space. And as you referred to a three-dose series, I wasn't sure exactly which direction you were going until you explained a bit. But yeah, so to be clear, in the U.S., we have a three plus one approach. So three vaccinations within the first six months of life; that's called the primary series, and then the fourth dose comes in the form of a boost the next year.

Out.

With regard to how the European authorities.

Handle that the study that we're running that will read out in 2025 with <unk> 24 and events is the conventional three plus one approach. So that's the data we will start with but to the extent, we see higher immune responses potentially once again after that primary series that could set us up for a.

Grant Pickering: In Europe, they restrict that primary series to only two vaccinations and then the third dose the next year. So it's really a three dose approach in Europe versus four dose approach. And, as you say, fewer doses create more pressure on lower immune responses.

<unk> better outcome to create even further competitive advantage relative to <unk> or 'twenty in Europe, but.

Grant Pickering: And so when Pfizer studied Prevnar 20 in infants in the U.S. and Europe, the impact of the one less dose was quite profound. So in the U.S., there were six of the serotypes that missed the non-inferiority comparison to Prevnar 13 after the primary series. And one can imagine that when you only give two vaccinations with a vaccine that's providing lower immune responses, the impact of that would be felt in a fewer vaccination approach. And sure enough, the results of their phase three study in Europe had 11 of the common serotypes miss the non-inferiority comparison at the primary series.

We'll see what that data looks like next year and then.

Seamus you were also asking about the potential to be 116 comparisons I thought you were first talking about <unk> 24 versus <unk> 31 in peds, but obviously you must be talking about adults only given that would be $1 16.

Will be restricted to the adult population to the extent it gets approved so.

Yes, I think we.

You're going to see we're going to get the benefit of having seen not only how the conversation is progressing with the ACI Pea later this week, but by the time, we would expect to get our Max 31 data will know for sure. If the vaccine is approved and if so how it's sequenced or recommended realm.

Grant Pickering: So that has been a big question mark. Nonetheless, the CHMP in Europe did recently recommend that Prevnar 20 ought to be approved, so it will be interesting to see how that plays out with that many missed non-inferiority comparisons.

Grant Pickering: But, to your point, what we've seen at least in adults with Vax24 data is that we are, for the most part, getting higher immune responses relative to Prevnar-20. And if that's the case, it could widen the advantage, certainly in a three-dose regimen versus a four-dose regimen. So, yeah, we'll have to see how some of this plays out with regard to how the European authorities handle that.

<unk>, two <unk> or 'twenty, so, yes, I think armed with that information, we'll have a much better sense of what the appropriate comparison would be for either back 24, or <unk> 31, 31 in particular, so I think that's a bit of a wait and see Jim anything to add.

I think I think that's there I think.

There is a non preferential recommendation then I think it will be up to us to choose which of the competitor. We can we can choose to use in the phase III.

Grant Pickering: You know, the study that we're running that we'll read out in 2025 with Vax24 in infants is the conventional three-plus-one approach. So that's the data we'll start with. But to the extent we see higher immune responses, potentially, once again, after that primary series, that could set us up for a potentially better outcome to create even further competitive advantage relative to Prevnar-20 in Europe. But we'll see what that data looks like next year.

Great. Thank you guys appreciate it.

Yeah. Thanks Seamus.

Thank you well go next now to Louise Chen at Cantor Fitzgerald.

Hi, Thanks for taking my question I wanted to ask you on Europe global manufacturing capacity and how that gives you a competitive advantage.

And then what kind of capacity you have once you complete the Buildout and second question I wanted to ask you with Jeff.

Jim: And then, Seamus, you were also asking about the potential V116 comparisons. I thought you were first talking about Vax24 versus Vax31 in peds, but obviously, you must be talking about adults only, given that V116 will be restricted to the adult population to the extent that it gets approved. So, yeah, I think, you know, we're going to see, we're going to get the benefit of having seen not only how the conversation is progressing with the ACIP later this week, but by the time we expect to get our Vax31 data, we'll know for sure if the vaccine is approved, and if so, how it's sequenced or recommended relative to Prevnar-20. So, yeah, I think armed So I think that's a bit of a wait and see. Jim, anything to add? No, I think that's fair.

Are you going to also choose either back 24, or <unk> 31 for instance.

What are you thinking here I wanted to go back 31 adult data I'm going to give you as you think about Atlas and opportunity.

Yeah, Thanks for the questions Luis.

Yeah, so as it relates to the manufacturing build out.

Competitive.

<unk>.

Perspective, it's really table Stakes if you will if you can't supply these vaccines at the appropriate capacity then.

How can you expect the ACI P. Among others to make a broad recommendation for your vaccine. So for US it's been fundamental to unlocking the full value of these vaccines is to stay ahead of that sort of capacity. So as to have not only the ability to deliver but the sort of profile that would warrant.

Jim: I think that if there's a non-preferential recommendation, then I think it'll be up to us to choose which of the comparator we can choose to use in phase 3. Great, thank you guys. Appreciate it. Yep. Thanks, Seamus.

Preferred recommendation ideally and so that's been absolutely crucial to this whole story and I think we've been able to stay ahead of that.

Louise Chinn: Thank you. We go next now to Louise Chinn at Camp. Hi, thanks for taking my question. I wanted to ask you about your global manufacturing capacity and how this gives you a competitive advantage. And then what kind of capacity will you have once you complete this build out?

No.

In a position to launch out of existing <unk> infrastructure, where we have been making these materials just steady clinically and then late last year as you all know we made the strategic decision to.

Invest in a dedicated facility at launch and as you.

Requested the way we're thinking about that dedicated facility is one that would be able to satisfy the global demand from the developed world for either back 24, or <unk> 31 in both of the adult and infant indications. So we do really expect that one to really deliver.

Grant Pickering: And the second question I wanted to ask you was just about the infant. Are you going to also choose either Vax24 or Vax31 for the infant? You know, what are you thinking here?

Grant Pickering: What is your Vax31 adult data gonna give you as you think about the infant output? Yeah. Thanks for the questions, Luis.

Grant Pickering: Yeah. So as it relates to the manufacturing buildout from a competitive perspective, it's really just table stakes, if you will. If you can't supply these vaccines at the appropriate capacity, then how can you expect the ACIP, among others, to make a broad recommendation for your vaccine? So for us, it's been fundamental to unlocking the full value of these vaccines to stay ahead of that sort of capacity. So as to have not only the ability to deliver but the sort of profile that would warrant a preferred recommendation, ideally.

<unk> for us to maximize the sort of opportunity that we think is at hand.

And then to your question about.

That's 24 versus <unk> 31, going forward I think it's really an indication dependent conversation so for us.

We find ourselves in a position where both <unk> 24, and <unk> 31 to have an opportunity to reach the market.

On the same timeline, so with the write backs 31 data later this year naturally it would make sense for us to move to deliver the most broadly protective vaccine that we can and ideally that would be back 31, if not we know that 24, it looks really good as well and so we'll wait to see that data before.

Grant Pickering: And so that's been absolutely crucial to this whole story, and I think we've been able to stay ahead of that. We're in a position to launch out of existing Lonza infrastructure, where we've been making these materials just for clinical study. And then late last year, as you all know, we made the strategic decision to invest in a dedicated facility at Lonza. And as you requested, the way we're thinking about that dedicated facility is one that would be able to satisfy global demand from the developed world for either Vax24 or Vax31 in both of the adult and infant indications. So, we do really expect that one to really deliver for us to maximize the sort of opportunity that we think is at hand.

Anointing, which one to advance that said in the infant market.

We're already well ahead with <unk> 24, and so for US we're contemplating.

Either or both of <unk> 24, or <unk> 31 in the infant indication just because we know we can bring back 24 to market faster based on the path. We're on today. So it's a little more nuanced in the infant indication because of that sequencing.

Grant Pickering: And then to your question about Vax24 versus Vax31 going forward, I think, you know, it's really an indication-dependent conversation. So for us, we find ourselves in a position where both Vax24 and Vax31 have an opportunity to reach the market on the same timeline. So with the right Vax31 data later this year, naturally, it would make sense for us to move to deliver the most broadly protective vaccine that we can. And, ideally, that would be Vax31. If not, we know Vax24 looks really good as well.

Yeah.

Thank you.

Sure.

Thank you we'll go next now to Joseph Stringer at Needham.

Hi, Thanks for taking our question.

Just a couple of quick ones on the preclinical programs I briefly mentioned this but could you just give us a quick sense for which one do you think could enter the clinic first and in particular on strep a.

Just curious if you give us a quick outlined how the competitive landscape there and what you think the commercial opportunity in that indication is.

Sure. Thanks.

Thanks, Joe.

Grant Pickering: And so we'll wait to see that data before anointing which one to advance. That said, in the infant market, we're already well ahead with Vax24, and so for us, we're contemplating either or both of Vax24 or Vax31 in the infant indication, just because we know we can bring Vax24 to market faster based on the path we're on today. So it's a little more nuanced in the infant indication because of that sequencing. We're going to go next to Joseph Stringer now.

As we stated we've got three.

Other pipeline projects, we've got a group a strep paradigm <unk>.

Together all three are moving forward in early stage preclinical development, we haven't guided to when.

They would go into clinic.

One that I believe is most advanced at this point is the one that you mentioned, which is group a strep.

The group a strep vaccine.

Joseph Stringer: Hi, thanks for taking our questions. Just a couple of quick ones on the preclinical programs. I briefly mentioned those, but could you just give us a quick sense for which one you think could enter the clinic first, and in particular, for strep A? Curious if you could give us a quick outline of the competitive landscape there and what you think the commercial opportunity and that indication is. So, you know, as we stated, we've got three other pipeline projects. We've got group A streptococcus periodontitis and Shigella. All three are moving forward in early stage, preclinical development. We haven't guessed when they would go into the clinic, but I think the one that I believe is most advanced at this point is the one that you mentioned, which is group A strep. The group A strep vaccine, I think, has a very important role. I think it's one of the most underappreciated diseases.

I think has a very important role I think it's one of the most underappreciated diseases.

There are over 500000 deaths due to group a strep that occur every year due to the dramatic heart disease.

The ubiquitous disease, causing pharyngitis, mainly in school entry kids as well.

As young toddlers.

Not treated aggressively with antibiotics, which means that there is a significant amount of antibiotic prescriptions associated with this disease and also subsequently you would expect.

Levels of anti microbial resistance.

Led to increasing importance of finding.

Our vaccine to prevent against this and there is there is recent economic safe to say that.

Medical and indirect costs are around $5 billion a year. So a vaccine that can have.

Jim: There are over 500,000 deaths due to group A strep that occur every year due to rheumatic heart disease. But it's a ubiquitous disease causing pharyngitis, you know, mainly in school-age kids as well as young toddlers. It's not treated, you know, aggressively with antibiotics, which means that there is a significant amount of antibiotic prescriptions associated with this disease. And also, subsequently, as you would expect, growing levels of antimicrobial resistance have led to the increasing importance of finding a vaccine to prevent this. And there are recent economic studies that say that medical and indirect costs are around 5 billion a year. So a vaccine that can have some degree of efficacy, a reasonable amount of efficacy, could significantly reduce direct medical costs. So I think you'll see a commercial opportunity here in school-entry kids, potentially toddlers. And then the one area I haven't mentioned is that there are high rates of invasive disease in older adults as well.

Some degree of efficacy a reasonable amount of effort we could see.

We have direct medical costs, offset so I think youll see a commercial opportunity here.

School entry kit potentially toddlers and then the one area I haven't mentioned that there's high rates of invasive disease in older adults as well so we could see a very similar type of.

Our recommendation in fact, a little bit more because you're immunizing school entry kids as well.

You see with the PCB. So so we're really excited about this program.

I think from a competitive standpoint Joey.

<unk>.

It's not as active as certainly will PCB space.

Yes.

There is minimal activity there is only a few academic centers and one.

Pharma company that are currently looking at a group a strep vaccine so minimal.

Jim: So we could see a very similar type of recommendation. In fact, a little bit more because you're immunizing school entry kids as well as you see with the PCVs, so we're really excited about this program. And I think from a competitive standpoint, Joey, it's not as active as certainly in the PCV space, and Jimmy can comment on that. Yeah, there's minimal activity. There are only a few academic centers and one pharma company that are currently looking at a group-based strep vaccine.

Relative environment as well.

Great. Thank you for taking my questions.

Thank you and ladies and gentlemen, it appears we have no further questions. Today. So that will conclude today's backsight fourth quarter and full year 2023 earnings conference call. Please disconnect. Your lines at this time and have a wonderful day, thanks for joining everyone.

Goodbye.

Uh-huh.

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Jim: So, minimal competitive environment. Great, thank you for taking our question. Thank you, and ladies and gentlemen, it appears we have no further questions today, so that will conclude today's Vaxcyte fourth quarter and full year 2023 earnings conference call. Please disconnect your line at this time and have a wonderful day. Goodbye.

Okay.

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Yeah.

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Sure.

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Uh huh.

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Okay.

Yeah.