Q4 2020 Vaxcyte Inc Earnings Call

March 29, 2021

Good afternoon, My name is Sarah and I'll be your conference operator today.

Operator 3: Good afternoon. My name is Sarah, and I will be your conference operator today. At this time, I would like to welcome everyone to the Vaxcyte Q4 and Full Year Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. 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, please press the pound key. Thank you. I will now turn the call over to Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. Please go ahead, sir.

Operator: Good afternoon. My name is Sarah and I will be your conference operator today. At this time, I would like to welcome everyone to the Vaxcyte Q4 and full-year financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. 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, please press the pound key. Thank you. I will now turn the call over to Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. Please go ahead, sir.

Operator: Good afternoon. My name is Sarah, and I will be your conference operator. At this time, I would like to welcome you

At this time I would like to welcome everyone to the back side fourth quarter and full year financial results Conference call.

Operator: Welcome, everyone, to the Vaxcyte fourth quarter and four-year financial results conference call.

Operator: All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time...

All lines have been placed on mute to prevent any background noise.

After the Speakers' remarks, there'll be a question and answer session and.

And would like to ask the question go on this time simply press star followed by the number one on your telephone keypad.

Operator: This time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press the pound key. Thank you. I will now turn the call over to Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. Please go ahead, sir.

And people like to withdraw your question. Please press the pound key.

Thank you.

I'll now turn the call over to Andrew Guggenheim, President and Chief Financial Officer of that site.

Andrew L. Guggenhime: Thank you, Operator, and good afternoon, everyone. I'd like to welcome you to Vaxcyte's earnings conference call to discuss the financial results for the quarter and full year ended December 31st, 2020 and to provide a business update. I am joined today by our CEO, Grant Pickering, our COO, Jim Wassil, and our VP of Research, Jeff Thurman. Earlier this afternoon, Vaxcyte issued a news release announcing the company's results. Copies of our news releases, latest corporate presentations, and SEC filings can be found in the Investors and Media section of our website.

Please go ahead Sir.

Thank you operator, and good afternoon, everyone.

Andrew Guggenhime: Thank you operator, and good afternoon, everyone. I'd like to welcome you to Vaxcyte's earnings conference call to discuss the financial results for the quarter and full year ended December 31, 2020, and to provide a business update. I am joined today by our CEO, Grant Pickering, our COO, Jim Wassil, and our VP of Research, Jeff Fairman. Earlier this afternoon, Vaxcyte issued a news release announcing the company's results. Copies of our news releases, 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 and uncertainties.

Andrew Guggenhime: Thank you, operator and good afternoon, everyone. I'd like to welcome you to Vaxcyte's earnings conference call to discuss the financial results for the quarter and full year ended December 31, 2020, and to provide a business update. I am joined today by our CEO, Grant Pickering, our COO, Jim Wassil, and our VP of Research, Jeff Fairman. Earlier this afternoon, Vaxcyte issued a news release announcing the company's results. Copies of our news releases, 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 and uncertainties.

And I'd like to welcome you to backstage the earnings conference call to discuss the financial results for the quarter and full year ended December 31, 2020 and to provide a business update.

I'm joined today by our CEO of grants Pickering.

Oh, Oh, Jim Wassail, and their VP of research and Jeff Sherman.

Earlier this afternoon <unk> issued a news release announcing the company's results copies of our news releases latest corporate presentation, and our SEC filings can be found and the investors and media section of our website.

Andrew L. Guggenhime: 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 and uncertainties. These include statements regarding the anticipated process and timing of the development of our vaccine candidates, the timing of our IND application submission and top-line data from our clinical proof of concept study for Vax24, the potential benefits and market of our vaccine candidates and technology platform, the impact of the COVID-19 pandemic on our business, attainment of milestones, and our expected uses and sufficiency of cash and other funding to support our development programs and other operating expenses. Any forward-looking statements are based on facts and assumptions as of today, and we undertake no obligation to update them. Our actual results may differ materially from these expectations.

Before we begin I'd like to remind you that during this call we'll be making certain forward looking statements about back sites, which are subject to various risks and uncertainties. These include statements regarding the anticipated process and timing of the development of our vaccine candidates and the timing of our R&D application submission and topline data from our clinical per.

Andrew Guggenhime: These include statements regarding the anticipated process and timing of the development of our vaccine candidates, the timing of our IND application submission and top-line data from our clinical proof of concept study for VAX-24, the potential benefits and market of our vaccine candidates and technology platform, the impact of the COVID-19 pandemic on our business, attainment of milestones, and our expected uses and sufficiency of cash and other funding to support our development programs and other operating expenses. Any forward-looking statements are based on facts and assumptions as of today, and we undertake no obligation to update them. Our actual results may differ materially from these statements. Investors should read the risk factors set forth in Vaxcyte's Form 10-K for the year ended December 31, 2020, and any subsequent reports filed with the SEC.

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And the milestones and their expected uses of cash and sufficiency of cash and the other funding to support our development programs and the other operating expenses.

Any forward looking statements are based on facts and assumptions as of today and we undertake no obligation to update them for.

Our actual results may differ materially from these statements investors should read the risk factors set forth in <unk> form 10-K for the year ended December 31, 2020 and any subsequent reports filed with the SEC.

Grant E. Pickering: Investors should read the risk factors set forth in Vaxcyte's Form 10-K for the year ended December 31, 2020, and any subsequent reports filed with the SEC. With that, I would now like to turn the call over to Grant Pickering. Grant?

Andrew Guggenhime: With that, I would now like to turn the call over to Grant Pickering. Grant?

With that.

I would now like to turn the call over to grant Pickering.

Grant E. Pickering: Thanks, Andrew. And to all of you on the call and webcast, thanks for joining us today. The past year has been transformational for Vaxcyte as we have made meaningful progress across all areas of our business. This was highlighted by the progress of our vaccine pipeline, which continues to illustrate what we believe are the unique competitive advantages and scalability of our technology platform to enable us to deliver broader-spectrum and or more immunogenic vaccines.

Grant.

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

Grant Pickering: Thanks, Andrew. To all of you on the call and webcast, thanks for joining us today. The past year has been transformational for Vaxcyte as we have made meaningful progress across all areas of our business. This was highlighted by the progress of our vaccine pipeline, which continue to illustrate what we believe are the unique competitive advantages and scalability of our technology platform to enable us to deliver broader spectrum and/or more immunogenic vaccines. Our lead vaccine candidate is VAX-24, a 24-valent pneumococcal conjugate vaccine for PCV. For this program, we have achieved several key manufacturing milestones to support our IND application submission to enable the initiation of our clinical proof of concept study. VAX-24, along with VAX-31, form the basis of our PCV franchise strategy, targeting the existing $7 billion pneumococcal vaccine market.

The past year has been transformational for bauxite is we have made meaningful progress across all areas of our business. This was highlighted by the progress of our vaccine pipeline, which continued to illustrate what we believe are the unique competitive advantages and scalability of our technology platform to enable us to deliver broader spectrum and ore.

The more immunogenic vaccines.

Our lead vaccine candidate is <unk> 24 of 24 valent pneumococcal conjugate vaccine for PCB for this program. We have achieved several key manufacturer and milestones to support our A&D application submission to enable the initiation of our clinical proof of concept study.

Grant E. Pickering: Our lead vaccine candidate is Vax24, a 24-valent pneumococcal conjugate vaccine (PCV). For this program, we have achieved several key manufacturing milestones to support our IND application submission to enable the initiation of our clinical proof-of-concept study. Vax24, along with VaxXP, forms the basis of our PCV franchise strategy, targeting the existing $7 billion pneumococcal vaccine market. Vax24 is designed to improve upon the standard of care in this market by covering the additional strains that are responsible for the majority of residual pneumococcal disease currently in circulation.

And it's 24, along with bats, XP form the basis of our PCB franchise strategy targeting the existing 7 billion dollar and pneumococcal vaccine market. The next 24 is designed to improve upon the standard of care and this market and covering the additional strains that are responsible for the majority of residual of pneumococcal disease currently and circa.

Grant Pickering: VAX-24 is designed to improve upon the standard of care in this market by covering the additional strains that are responsible for the majority of residual pneumococcal disease currently in circulation. Based on the data we've generated to date, we believe VAX-24 has the potential to protect against the strains collectively covered by the leading PCV, Prevnar 13, and the older, less immunogenic form of vaccine called Pneumovax 23. We believe that VAX-24 has the opportunity to replace both standard of care vaccines with a single broad-spectrum PCV.

Relation.

Grant E. Pickering: Based on the data we've generated to date, we believe Vax24 has the potential to protect against the strains collectively covered by the leading PCV, Prevnar 13, and the older, less immunogenic form of vaccine called Pneumovax 23. We believe that Vax24 has the opportunity to replace both standard of care vaccines with a single broad-spectrum vaccine. Our site-specific conjugation technology creates a competitive advantage that allows us to engineer broader-spectrum PCBs designed to avoid carrier suppression in ways that we believe will afford our PCB franchise an opportunity to surpass the coverage of our competitors, which has been the key adoption determinant in this market.

Based on the data we've generated to date, we believe the next 24 has the potential to protect against the strains and collectively covered by the leading PCB prep and our 13th and the older less immunogenic form of vaccine called Pneumovax 23.

We believe the batch 20 for has the opportunity to replace both standard of care of vaccines with the single broad spectrum PCB. Our site specific conjugation technology creates a competitive advantage that allows us to engineer a broader spectrum P. C. B's designed to avoid carrier suppression and ways that we believe will afford.

Grant Pickering: Our site-specific conjugation technology creates a competitive advantage that allows us to engineer broader spectrum PCVs designed to avoid carrier suppression in ways that we believe will afford our PCV franchise an opportunity to surpass the coverage of our competitors, which has been the key adoption determinant in this market. For VAX-31, we continue to lay the groundwork to support a level of readiness to push the spectrum of coverage even further to address newly emerging strains and extend our competitive advantage. Today, we are announcing compelling new data generated with our latest conjugates produced at larger scale at Lonza, our CMO. We also made significant progress on our prophylactic vaccine candidate, VAX-A1, which is designed to prevent Group A Strep infections. This work led to nominating our final vaccine candidate in Q1 of this year, accomplishing one of our stated 2021 milestones.

Our P C D franchise and opportunity to surpass the coverage of our competitors, which has been the key adoption determinant and this market.

For <unk> X P and we continue to lay the groundwork to support our level of readiness to push the spectrum of coverage, even further to address newly emerging strains and extend our competitive advantage today, we are announcing compelling new data generated with our latest conjugates produced at larger scale at launch.

Grant E. Pickering: For VaxXP, we continue to lay the groundwork to support a level of readiness to push the spectrum of coverage even further to address newly emerging strains and extend our competitive advantage. Today, we are announcing compelling new data generated with our latest conjugates produced at a larger scale at Lonza, our CMO.

We also made significant progress on a prophylactic vaccine candidate back day, one which is designed to prevent group a strep infections.

Grant E. Pickering: We also made significant progress on our prophylactic vaccine candidate, VaxA1, which is designed to prevent group A strep infection. This work led to nominating our final vaccine candidate in the first quarter of this year, accomplishing one of our stated 2021 milestones. The global need for a vaccine to treat group A strep is clear.

And this work led the nominating our final vaccine candidate and the first quarter of this year accomplishing one of our stated 2021 milestones and the global need for a vaccine to treat group a strep is clear based on our recently published data. We are increasingly excited about the potential to deliver a best in class and first in class vaccine for multiple.

Grant Pickering: The global need for a vaccine to treat Group A Strep is clear. Based on our recently published data, we are increasingly excited about the potential to deliver a best-in-class and first-in-class vaccine for multiple age groups. We also continued to advance VAX-PG, our vaccine designed to treat periodontal disease, and anticipate nominating the final candidate in H2 of this year. Behind the scenes, we're also making progress with earlier stage vaccine discovery programs that leverage our platform. Aside from our pipeline progress, we executed two successful financings in 2020, raising gross proceeds of $110 million in our Series D financing in March and $287 million in our IPO in June. As a result, our balance sheet remains strong to fund our programs through the anticipated key VAX-24 clinical proof of concept milestone.

Grant E. Pickering: Based on our recently published data, we are increasingly excited about the potential to deliver a best-in-class and first-in-class vaccine for multiple age groups. We also continue to advance VaxPG, our vaccine designed to treat periodontal disease, and anticipate nominating the final candidate in the second half of this year. Behind the scenes, we're also making progress with earlier stage vaccine discovery programs that leverage our platform. Aside from our pipeline progress, we executed two successful financings in 2020, raising gross proceeds of $110 million in our Series D financing in March and $287 million in our IPO in June.

The age groups. We also continued to advance Fox P. G. R vaccine designed to treat periodontal disease and anticipate nominating the final candidate and the second half of this year.

Behind the scenes, we're also making progress with earlier stage vaccine discovery programs that leverage our platform.

Aside from our pipeline progress we executed two successful financings in 2020, raising gross proceeds of $110 million and our series D financing in March and $287 million and of our IPO in June as a result, our balance sheet remained strong to fund our programs through the anticipated key back.

Grant E. Pickering: As a result, our balance sheet remains strong to fund our programs through the anticipated QIVAX 24 clinical proof of concept milestone. And finally, we added a number of key leaders and team members to support the advancement of our pipeline, our transition to being a public company, and the overall growth of our business. While we achieved several significant IND-enabling milestones over the past year for Vax24, we are changing our estimate for the timing of our anticipated IND submission from the second half of 2021 to now between January and June of 2022. This change is due primarily to additional time required to complete the ongoing drug substance manufacturing, along with capacity constraints at our CMO and the impact from Jim will share additional background on this short.

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Grant Pickering: Finally, we added a number of key leaders and team members to support the advancement of our pipeline, our transition to being a public company, and the overall growth of our business. While we achieved several significant IND-enabling milestones over the past year for VAX-24, we are changing our estimate to the timing for our anticipated IND submission from H2 2021 to now between January and June 2022. This change is due primarily to additional time required to complete the ongoing drug substance manufacturing, along with capacity constraints at our CMO and the impact from the COVID-19 pandemic.

And finally, we added a number of key leaders and team members to support the advancement of our pipeline our transition to being a public company and the overall growth of our business.

While we achieved several significant ied enable and milestones over the past year for <unk> 'twenty for we are changing the estimate for the timing for our anticipated and submission from the second half of 2021 to now between January and June of 2020 two.

This change is due primarily to additional time required to complete the ongoing drug substance manufacturing along with capacity constraints and our CMO and the impact from the COVID-19, pandemic and Jim will share additional background on this shortly.

Grant Pickering: Jim will share additional background on this shortly. With respect to our Phase I/II clinical study that will follow the IND submission for VAX-24, we expect to deliver the top-line data between late 2022, which is within our prior guidance, and early 2023. Given the magnitude of the market opportunity and the attractive profile of our PCV candidates, we're committed to taking the necessary steps in time to deliver the 24 conjugated drug substances that we believe will maximize our potential for long-term success. We believe the scalability of our technology platform is unrivaled, so as to deliver the broadest spectrum PCVs while still honoring the key conventions of proven PCVs, which have been tremendously successful to date. Vaccine developers, particularly those targeting invasive pneumococcal disease, generally have been focused on overcoming two challenges. The first is carrier suppression and the second is antigenic competition.

Grant E. Pickering: With respect to our Phase 1-2 clinical study that will follow the IND submission for VAX-24, we expect to deliver top-line data between late 2022, which is within our prior guidance, and early 2023. Given the magnitude of the market opportunity and the attractive profile of our PCB candidates, we're committed to taking the necessary steps in time to deliver the 24 conjugated drug substances that we believe will maximize our potential for long-term success.

With respect to our phase one two clinical study that will follow the IDE submission for <unk> 'twenty for we expect to deliver the top line data between late 2020 two with the <unk>, which is within our prior guidance and early 2023.

Given the magnitude of the market opportunity and the attractive profile of our PCB candidates. We are committed to taking the necessary steps and time to deliver the 'twenty for conjugated drug substances that we believe will maximize our potential for long term success.

Grant E. Pickering: We believe the scalability of our technology platform is unrivaled, so as to deliver the broadest spectrum of PCBs while still honoring the key conventions of proven PCBs, which have been tremendously successful to date. Vaccine developers, particularly those targeting invasive pneumococcal disease, generally have been focused on overcoming two challenges. The first is carrier suppression, and the second is antigenic competition.

We believe the scalability of our technology platform is unrivaled and so as to deliver the broadest spectrum Pcbs and while still honoring the key conventions of proven Pcbs, which have been tremendously successful to date.

Vaccine developers, particularly those targeting invasive pneumococcal disease generally had been focused on overcoming two challenges. The first is carrier suppression and the second is antigenic competition.

Grant E. Pickering: To date, the pre-political data for Vax24 have demonstrated the potential for our platform to overcome these challenges. This is further exemplified by VaxXP, where the latest preclinical data that we are sharing today show robust immunogenicity across the board, with an even broader spectrum PCV when compared to the standard of care vaccine. The results are available for review in our 10K, an updated corporate overview presentation that's now available on our website. These data give us further confidence that we have a PCB franchise that has the potential to attain a leadership position and maintain that position in the long run, despite spirited competition. I'll now turn it over to Jim to give you a more detailed update on our pipeline, beginning with Vax24.

Grant Pickering: To date, the pre-clinical data for VAX-24 have demonstrated the potential for our platform to overcome these challenges. This is further exemplified by VAXXP, where the latest pre-clinical data that we are sharing today show robust immunogenicity across the board, with an even broader spectrum PCV when compared to the standard of care vaccines. The results are available for review in our 10-K and updated corporate overview presentation that's now available on our website. These data give us further confidence that we have a PCV franchise that has the potential to attain a leadership position and maintain that position in the long run despite spirited competition. I'll now turn it over to Jim to give you a more detailed update on our pipeline, beginning with VAX-24.

To date, the preclinical data for Bax 'twenty for have demonstrated the potential for our platform to overcome these challenges. This is further exemplified buybacks X P where the latest preclinical data that we are sharing today show robust immunogenicity across the board with an even broader spectrum PCB win.

Prior to the standard of care vaccines. The results are available for review on our 10-K and updated corporate overview presentation. That's now available on our website. These day to give us further confidence that we have of PCB franchise that has the potential to attain a leadership position and maintain the position and the long runs and despite some.

Barrett and competition.

I'll now turn it over to Jim to give you a more detailed update on our pipeline beginning with <unk> 20 for.

Thanks Grant.

Jim Wassil: Thanks, Grant. Before I get into our accomplishments for VAX-24 and the status update, I think it'd be helpful to review the manufacturing process for this program and the remaining activities necessary to enable the IND application submission. As we previously shared, the manufacturing process for VAX-24 includes the following 4 steps. First, we manufacture eCRM, our proprietary protein carrier. Second, we manufacture 24 pneumococcal polysaccharides, 1 for each of the serotypes included in VAX-24. Third, we manufacture 24 conjugated drug substances, which consist of 3 discrete stages. First, each of the 24 polysaccharides is sized to a targeted molecular weight. Then a linker is attached to each of the 24 sized polysaccharides to generate 24 activated polysaccharides. Finally, the 24 activated polysaccharides are conjugated or covalently linked to the eCRM carrier protein, resulting in the 24 conjugated drug substances.

James Wassil: Before I get into our accomplishments for VAX 24 and the status update, I think it would be helpful to review the manufacturing process for this program and the remaining activities necessary to enable the I&D application submission. As we previously shared, the manufacturing process for VAX-24 includes the following four steps.

Before I get into our accomplishments for <unk> 'twenty for and the status update I think it'd be helpful to review the manufacturing process for this program and the remaining activities necessary to enable the and I N D application submission.

As we've previously shared the manufacturing process for Bax 24 includes the following four steps first we manufacture of <unk>, our proprietary protein carrier.

James Wassil: First, we manufacture Ecrim, our proprietary protein. Second, we manufacture 24 pneumococcal polysaccharides, one for each of the serotypes included in Vax24. Third, we manufacture 24 conjugated drug substances that consist of three discrete stages. First, each of the 24 polysaccharides is sized to a targeted molecular weight. Then, a linker is attached to each of the 24 sized polysaccharides to generate 24 activated polysaccharides. And finally, the 24 activated polysaccharides are conjugated or covalently linked to the E cream carrier protein, resulting in the 24 conjugated drugs.

We manufacture 'twenty for pneumococcal polysaccharides, one for each of the serotypes included in back of 24.

Third we manufacture twenty-four conjugate the drug substances, which consist of three discrete stages first each of the 20 per polysaccharides decides to the targeted molecular weight.

And the Lakers attached to each of the 24 sides polysaccharides to generate 20 for activated polysaccharides and.

And finally, the 20 for activated polysaccharides are conjugated of Kobe linked to the E cream carrier protein, resulting in the 'twenty for conjugated drug substances.

James Wassil: The fourth and final step of the process includes manufacture of the drug product by mixing the 24 conjugated drug substances and filling them into vials. To date, we've made significant progress towards our IND filing, including a number of key accomplishments in the past.

Jim Wassil: The fourth and final step of the process includes manufacture of the drug product by mixing the 24 conjugated drug substances and filling into vials. To date, we've made significant progress towards our IND filing, including a number of key accomplishments in the past year. We've successfully completed the GMP manufacture, testing, and release of both the eCRM carrier protein and the 24 pneumococcal polysaccharides. For the conjugated drug substance, we have now successfully sized and activated each of the 24 polysaccharides and are in the midst of the manufacturing of each of the 24 conjugated drug substances. Earlier this year, we successfully manufactured our initial drug product batches with our 24 conjugates at Lonza. These batches will serve as the source of our lead lock stability data for our IND.

The fourth and final step of the process includes manufacturer of the drug product by mixing the twenty-four conjugated drug substances and filling and survives.

To date, we've made significant progress towards our IND filing, including the number of key accomplishments and the past year we.

James Wassil: We've successfully completed the GMP manufacture, testing, and release of both the E-Crim Carrier Protein and the 24-pneumococcal polysaccharide. For the Conjugated Drug Substance, we have now successfully sized and activated each of the 24 polysaccharides and are in the midst of the manufacturing of each of the 24 Conjugated Drug Substances. Earlier this year, we successfully manufactured our initial drug product batches with our 24 conjugates at Lonzo. Dispatchers will serve as the source of our lead loss stability data for our... We also successfully completed the manufacturing of drug product batches used in the GOP Toxicology Studies and initiated the GOP Toxicology Study in the first quarter of this year.

We successfully completed the G P manufacture testing and release of both the E cream carrier protein and the 20th for Pneumococcal polysaccharides for.

For the conjugate the drug substance, we've now successfully sized and activate at each of the 20 per call soccer rights and are in the midst of the manufacturing of each of the 'twenty for conjugated drug substances.

Earlier this year, we successfully manufactured on our initial drug product batches with our 'twenty for conjugates.

These batches will serve as the source of our lead lot stability data for our and I N T.

We also successfully completed manufacturing of drug product batches to Houston, and the GOP toxicology studies and initiated the GOP toxicology study and the first quarter of this year.

Jim Wassil: We also successfully completed manufacturing of drug product batches used in the GLP toxicology studies and initiated the GLP toxicology study in Q1 of this year. Now, before we submit our IND, we still have a few outstanding items, which include, first, completion of the GMP manufacturing, testing, and release of the conjugated drug substances and drug product. Second, completion of the GLP toxicology study that is currently underway. And third, generation and submission of stability data resulting from the GMP drug product. As Grant mentioned, we are updating our guidance for the VAX-24 IND submission as a result of a few factors, which I will provide more detail on. First, as we have progressed through the manufacture of the 24 drug substances, we experienced some process-related issues as we transitioned into GMP production at Lonza.

And before we submit our R&D, we still have a few outstanding items, which include first completion of the GMP manufacturing testing and release of the conjugate the drug substances and drug product.

James Wassil: Now, before we submit our IND, we still have a few outstanding items, which include, first, completion of the GMP manufacturing, testing, and release of the conjugated drug substances and drug products. Second, completion of the GOP toxicology study that is currently underway. And third, generation and submission of stability data resulting from the GMP drug.

Second completion of the GOP toxicology studies and that is currently underway and third generation and submission of stability data, resulting from the GMP drug product.

As Greg mentioned, we are updating our guidance for the back of 24 and D submission as a result of a few factors, which I'll provide more detail on.

James Wassil: As Grant mentioned, we are updating our guidance for the VAX-24-IND submission as a result of a few factors, which I will provide more detail on. First, as we have progressed through the manufacture of the 24 drug substances, we experienced some process-related issues as we transitioned into GMP production at launch. In and of themselves, these only caused minor delays across the three stages of production, but taken together, they have resulted in a meaningful cumulative delay to the vaccine development. While these adjustments are typical for this stage of the vaccine development, and our initial guidance has accounted for process modifications, we underestimated the cumulative impact of these changes.

First as we have progressed through the manufacturer of the 20th for drug substances, we experienced some process related issues as we transitioned into the GMP production of Atlanta and.

Jim Wassil: In and of themselves, these only caused minor delays across the 3 stages of production, but taken together, have resulted in a meaningful cumulative delay to the campaign. While these adjustments are typical for this stage of the vaccine development, and our initial guidance has accounted for process modifications, we underestimated the cumulative impact of these changes. As I noted, we have now progressed successfully through the first 2 stages of the drug substance production campaign and are in the midst of the final stage of conjugating the 24 drug substances. Ultimately, before we were able to complete the final conjugation stage, we encountered an interruption of the drug substance manufacturing campaign at Lonza. Now, working with a world-class CMO such as Lonza has many benefits. However, they also have numerous clients with late-stage clinical and commercial products.

And of themselves. These only cause minor delays across the three stages of production, but taken together have resulted in a meaningful cumulatively to the campaign.

While these adjustments are typical for this stage of the vaccine development and our initial guidance has accounted for process modifications, we underestimated the cumulative impact of these changes as I noted we have now progressed successfully through the first two stages of the drug substance production campaign and are in the midst of the final stage of conjugate the 'twenty for drug substances.

James Wassil: As I noted, we have now progressed successfully through the first two stages of the drug substance production campaign and are in the midst of the final stage of conjugating the 24 drug substances. However, ultimately, before we were able to complete the final conjugation stage, we encountered an interruption in the drug substance manufacturing campaign at launch. Now working with a world-class CMO such as Lonza has many benefits, but they also have numerous clients with late stage clinical and commercial products. As a result, our GMP Conjugate manufacturing campaign was unfortunately interrupted due to Alonzo's prior customer commitment.

Ultimately before we were able to complete the final conjugation stage, we encountered and interruption of the drug substance manufacturing campaign Atlanta.

And working with the World class team of of such as loans has many benefits. However, they also have numerous clients with late stage clinical and commercial products.

Jim Wassil: As a result, our GMP conjugate manufacturing campaign was unfortunately interrupted due to Lonza's prior customer commitments. The good news is that we have resumed our manufacturing campaign, the early data of which are encouraging, and working towards completing the 24 conjugated drug substances. Finally, the COVID-19 pandemic created some operational headwinds. Travel restrictions delayed the qualification of key analytical equipment and in-person CMO oversight. We also saw raw material supply chain slowed. Fortunately, we do believe these issues have now been resolved. All in all, we have made substantial progress towards delivering the VAX-24 IND and look forward to completing the remaining deliverables per our current guidance. As Grant noted, we're also announcing today new immunogenicity data for our VAX-31, our PCV candidate with expanded breadth of coverage of at least 30 strains.

And as a result, our G. P conjugate manufacturing campaign was unfortunately interrupted due to losses prior per customer commitments and the good news is that we have resumed our manufacturing campaign. The early data of which are encouraging and working towards completing the 'twenty for conjugate the drug substances.

James Wassil: The good news is that we have resumed our manufacturing campaign, the early data of which are encouraging, and working towards completing the 24 conjugated drug study. Finally, the COVID-19 pandemic created some operational challenges; travel restrictions delayed the qualification of key analytical equipment and in-person CMO over. We also sell raw material supply chains.

Finally, the COVID-19 pandemic created some operational headwinds travel restrictions delayed the qualification of the key analytical equipment and in person and CMO oversight.

We also saw raw material supply chain slumped. Fortunately, we do believe these issues have now been resolved on.

James Wassil: Fortunately, we do believe these issues have now been resolved. All in all, we have made substantial progress towards delivering the VAX-24-IND and look forward to completing the remaining deliverables per our current schedule. As Grant noted, we are also announcing today new immunogenicity data for our VAX-XP, our PCV candidate with expanded breadth of coverage of at least 30 strains. The strains in VaxxXP cover over 90% of invasive pneumococcal diseases currently circulating in the United States. The new data demonstrate the potential scalability and robustness of our technology platform. Importantly, they also demonstrate that during the scale-up and tech transfer to Lonza, the fidelity of the process was maintained.

And all we have made substantial progress towards delivering the backs of 'twenty for R&D and look forward to completing the remaining deliverables for our current guidance.

As Chris noted we are.

Also announcing today, new immunogenicity data for our Vax XP, our PCB candidate with expanded breadth of coverage of at least 30 strengths the strains and back to the X P cover over 90% of invasive pneumococcal disease currently circulating in the United States.

Jim Wassil: The strains in VAX-31 cover over 90% of invasive pneumococcal disease currently circulating in the United States. The new data demonstrate the potential scalability and robustness of our technology platform. Importantly, they also demonstrate that during the scale-up and tech transfer to Lonza, the fidelity of the process was maintained. In this study conducted in rabbits, we compared VAX-31 to more than 30 different pneumococcal serotypes, including all of those contained in Prevnar 13. The results showed that VAX-31 immune responses were at least comparable to Prevnar 13 and superior to polysaccharide-only serotypes like those contained in Pneumovax 23. Before turning it over to Jeff to provide an update on the status of VAX-A1, our prophylactic vaccine candidate designed to prevent Group A Strep infections, I want to touch upon the increasing global need for a vaccine to address this serious pathogen.

The new data demonstrate the potential scalability and robustness of our technology platform and <unk>.

Poorly they also demonstrate the touring the scale up and tech transfer to loans of the for.

Fidelity of the process was maintained.

And the study conducted in rabbits, we compared back 62 more than 30 different pneumococcal serotypes, including all of those contained and present our 30.

James Wassil: In this study conducted in rabbits, we compared VaxXP to more than 30 different pneumococcal spherotypes, including all of those contained in Prevnar 13. The results showed that Vax-XP immune responses were at least comparable to Prevnar-13 and superior to polysaccharide-only serotypes like those contained in Pneumovax-26. Before turning it over to Jeff to provide an update on the status of VaxA1, our prophylactic vaccine candidate designed to prevent group A strep infection, I want to touch upon the increasing global need for a vaccine to address this serious pathogen.

And the results showed the back 60 immune responses or at least comparable the prep and our 13th and superior to polysaccharide only serotypes of like those contained and Pneumovax 23.

Before turning it over to Jeff to provide and update on the status of factory one of prophylactic vaccine candidate designed to prevent group a strep infections I want to touch upon the increase and global need for a vaccine to address the series of pathogen.

Group, a strep is the ubiquitous disease, causing an estimated 700 million cases of disease globally. The majority of these are fair and Janus or strep throat, which result in significant usage of the antibiotic prescriptions and consequently, our of source of increased antibiotic resistance.

Jim Wassil: Group A Strep is a ubiquitous disease causing an estimated 700 million cases of disease globally. The majority of these are pharyngitis or strep throat, which result in significant usage of antibiotic prescriptions and consequently are a source of increased antibiotic resistance. Group A Strep can also have grave outcomes. There are an estimated 500,000 deaths per year globally due to the combination of rheumatic heart disease, and other invasive diseases. While traditionally thought of as a childhood disease, the rate of invasive disease in the elderly has increased substantially over the past decade. In the US, the estimated rate of invasive disease in adults 65 and over has more than doubled since 2012 and is now more than 3 times the rate of invasive pneumococcal disease when the CDC recommended Prevnar 13 for the adult population.

The group a strep can also have great outcomes.

James Wassil: Group A strep is a ubiquitous disease causing an estimated 700 million cases of disease globally. The majority of these are pharyngitis or strep throat, which result in significant usage of antibiotic prescriptions and consequently are a source of increased antibiotic resistance. Group A strep can also have grave outcomes. There are an estimated half a million deaths per year globally due to the combination of rheumatic heart disease and other invasive, are traditionally thought of as a charity.

There are an estimate of half of million deaths per year globally due to the combination of rheumatic heart disease and other invasive diseases.

Traditionally thought of as the childhood disease the rate of invasive disease of the elderly has increased substantially over the past decade.

And the U S. The estimated rate of invasive disease in adults 65, and over has more than doubled since 2012 and now more than three times the rate of invasive pneumococcal disease, when the CDC recommended pregnant and 13 for the adult population.

James Wassil: The rate of invasive disease in the elderly has increased substantially over the past decade. In the U.S., the estimated rate of invasive disease in adults 65 and over has more than doubled since 2012 and is now more than three times the rate of invasive pneumococcal disease when the CDC recommended Prevnar 13 for the adult population. This creates an opportunity to develop VaxA1 not only for children but also for adults. We believe VaxA1 has first-in-class and best-in-class potential to address this significant need. With that, I'll turn it over to Jeff to provide a program update.

Jim Wassil: This creates an opportunity to develop VAX-A1 not only for children, but also adults. We believe VAX-A1 has first in class and best in class potential to address this significant need. With that, I'll turn it over to Jeff to provide a program update.

This creates an opportunity to develop back the one not only for children, but also of adults.

We believe vaccine and one at first in class and best in class potential to address the significant need.

With that I'll turn it over to Jeff to provide a program update.

Thanks, Jim.

Jeff Fairman: Thanks, Jim. VAX-A1 leverages one of the key applications of our cell-free protein synthesis platform, the ability to produce site-specific polysaccharide protein conjugates. The resulting conjugate is designed to ensure optimal exposure of both the B and T-cell epitopes on the protein carrier to confer robust, boostable, and durable protective immune responses. VAX-A1 is designed to confer broad protection against subtypes of Group A Strep. It includes a conserved polysaccharide polyrhamnose conjugated to a Group A Strep specific immunogenic protein carrier using our site-specific conjugation technology, along with two highly conserved protein virulence factors that, when left unchecked, interfere with the body's ability to respond to the infection. By using these conserved antigens, we believe that our investigational vaccine could address the full range of pathogenic serotypes of Group A Strep. We continue to make solid progress with this program.

That's a wide and leverages one of the key applications of our cell free protein synthesis platform the ability to produce site specific polysaccharide protein conjugates.

And the resulting conjugate is designed to ensure optimal exposure of both the b and T cell epitopes on the protein carrier to confer robust boost of bolt and durable protective of immune responses.

Back say one is designed to confirm broad protection against subtypes of group a strep.

Jeff Thurman: VaxA1 leverages one of the key applications of our cell-free protein synthesis platform, the ability to produce site-specific polysaccharide protein conjugates. The resulting conjugate is designed to ensure optimal exposure of both the B and T cell epitopes on the protein carrier to confer robust, boostable, and durable protective immune responses. VaxA1 is designed to confer broad protection against subtypes of Group A streps. It includes a conserved polysaccharide, polyramnose, conjugated to a group-based strep-specific immunogenic protein carrier using our site-specific conjugation technology, along with two highly conserved protein virulence factors that, when left unchecked, interfere with the body's ability to respond to the infection.

It includes the concern polysaccharide probably ran dose.

Conjugated to a group a strep specific immunogenic protein carrier using our site specific conjugation technology.

Along with two highly conserved protein burial and factors that when left on check interfere with the body's ability to respond to the infection.

By using these conserved antigens, we believe that our investigational vaccine could address the full range of pathogenic serotypes of group a strep.

We continue to make solid progress with this program.

Earlier this year, we nominated our final vaccine candidate and consistent with our target timeline.

Jeff Fairman: Earlier this year, we nominated our final vaccine candidate consistent with our target timeline. In connection with this nomination, we recently completed the first phase of our award under our agreement with CARB-X. In addition, at the beginning of this year, we announced the publication of preclinical data from our program in Infectious Microbes & Diseases. In the published study, which was carried out in collaboration with researchers at the University of California San Diego, VAX-A1 showed broad and significant protection against systemic and soft tissue infection after animals were challenged with near lethal amounts of Group A Strep bacteria. Broad-based cross-reactivity with multiple serotypes of Group A Strep was observed in the serum of vaccinated animals. No cross-reactivity was detected with human heart or brain proteins, which is a key leading indicator of vaccine safety.

Jeff Thurman: By using these conserved antigens, we believe that our investigational vaccine could address the full range of pathogenic serotypes of group A stress. We continue to make solid progress with this program. Earlier this year, we nominated our final vaccine candidate consistent with our target timeline. In connection with this nomination, we recently completed the first phase of our award under our agreement with CARBEC.

In connection with this nomination we recently completed the first phase of our awards under our agreement with Carb X.

In addition at the beginning of this year, we announced the publication of preclinical data from our program and the true infectious microbes and diseases.

And the published study, which was carried out in collaboration with researchers at the University of California, San Diego back.

Jeff Thurman: In addition, at the beginning of this year, we announced the publication of preclinical data from our program in the germ, infectious microbes, and disease. In the published study, which was carried out in collaboration with researchers at the University of California, San Diego, VaxA1 showed broad and significant protection against systemic and soft tissue infection after animals were challenged with near-lethal amounts of group A strep bacteria. Broad-based cross-reactivity with multiple serotypes of group A strep was observed in the serum of vaccinated animals.

Back say, one showed broad and third significant protection against the systemic and soft tissue infection. After animals were challenged with near lethal amounts of group a strep bacteria.

Broad based cross reactivity with multiple Sarah types of group, a strep was observed and the serum of vaccinated animals.

No cross reactivity was detected with human heart or brain proteins, which is of key leading indicator of vaccine and safety.

Looking ahead, we expect to initiate IND, enabling activities and the second half of this year.

Jeff Fairman: Looking ahead, we expect to initiate IND-enabling activities in H2 of this year and are currently working with CARB-X to finalize the next potential phase of our cost reimbursement research award with them. VAX-PG, our novel therapeutic vaccine designed to treat periodontal disease, leverages another key application of our cell-free protein synthesis platform, the ability to produce tough-to-make protein antigens. Periodontal disease affects an estimated 65 million adults in the United States. Globally, severe periodontal disease afflicts 10% to 15% of the adult population, resulting in productivity losses estimated at nearly $54 billion. Periodontitis has also been shown to be associated with increased risk of heart attack, stroke, cardiovascular disease, and Alzheimer's disease. VAX-PG targets Porphyromonas gingivalis, the keystone pathogen responsible for periodontitis.

Jeff Thurman: No cross-reactivity was detected with human heart or brain proteins, which is a key leading indicator of vaccine safety. Looking ahead, we expect to initiate IND-enabling activities in the second half of this year and are currently working with CARB-X to finalize the next potential phase of our Cost Reimbursement Research Award with Vax PG, our novel therapeutic vaccine designed to treat periodontal disease. Leverage is another key application of our cell-free protein synthesis platform. The ability to produce tough-to-make protein answers

And are currently working with <unk> to finalize the next potential phase of our cost reimbursement Research award with them.

The <unk> P. G are novel therapeutic vaccine designed to treat periodontal disease Leverages and other key application of our cell free protein synthesis platform the ability to produce test and make protein to antigens.

Periodontal disease affects an estimated 65 million adults and the United States globally severe periodontal disease afflicts, 10% to 15% of the adult population, resulting and productivity losses estimated at nearly $54 billion.

Jeff Thurman: Periodontal disease affects an estimated 65 million adults in the United States. Globally, severe periodontal disease afflicts 10-15% of the adult population, resulting in productivity losses estimated at nearly $54 billion. Periodontitis has also been shown to be associated with increased risk of heart attack, stroke, cardiovascular disease, and Alzheimer's disease.

Periodontitis has also been shown to be associated with increased risk of heart attack stroke, cardiovascular disease and Alzheimers disease.

Thanks P. J targets tour for bonus change of all is the Keystone pathogen responsible for a period on Titus.

Jeff Thurman: Vax PG targets Porphymonis gingivalis, the keystone pathogen responsible for periodontitis. VaxPG incorporates protein antigens that we believe are uniquely enabled with our technology, due to their inability to be produced in conventional production vectors either at all or at sufficient yields to permit commercial-scale supply. We have established preclinical proof of concept for this program based on data published in the Journal of Clinical Periodontology. In the study, VaxPG demonstrated robust protein-specific IgG responses following immunization and protected mice from P. gingivalis-elicited oral bone loss, which is a clinical manifestation of periodontitis.

Jeff Fairman: Vax-PG incorporates protein antigens that we believe are uniquely enabled with our technology due to their inability to be produced in conventional production vectors, either at all or at sufficient yields to permit commercial scale supply. We have established preclinical proof of concept for this program based on the data published in the Journal of Clinical Periodontology. In the study, Vax-PG demonstrated robust protein-specific IgG responses following immunization and protected mice from P. gingivalis-elicited oral bone loss, which is a clinical manifestation of periodontitis. We are advancing the program toward our corporate target to nominate our final vaccine candidate, which we expect to occur in H2 of this year. The third novel dimension of our platform technology is the ability to conjugate immunomodulatory molecules to candidate antigens.

Backstage and incorporates protein of antigens that we believe are uniquely enabled with our technology.

Due to their inability to be produced and conventional production vectors either at all or at sufficient yields to permit commercial scale supply.

We have established preclinical proof of concept for this program based on the data published in the journal of clinical paradigm apology.

And the study Vacs P. G demonstrated robust protein specific IGT responses following immunization and protected mice from P. Ginger Polish elicited oral bone loss, which is a clinical manifestation of period and Titus.

We are advancing the program toward our corporate target denominator of final vaccine candidate, which we expect to occur and the second half of this year.

Jeff Thurman: We are advancing the program toward our corporate target to nominate our final vaccine candidate, which we expect to occur in the second half of this year. A third novel dimension of our platform technology is the ability to conjugate immunomodulatory molecules to candidate antigens. Earlier this month, we and our collaborators published a paper in Scientific Reports where we demonstrated an enhanced CD8 positive T cell response by directly conjugating an adjuvant to the candidate antigen. This expansion of our site-specific technology platform has the potential application in viral vaccines, where an enhanced CD8 T cell response is required. I will now turn it over to Andrew for a financial update.

The third novel dimensions of our platform technology is the ability of the conjugate immuno modular Tory molecules the candidate of the antigens.

Jeff Fairman: Earlier this month, we and our collaborators published a paper in Scientific Reports where we demonstrated an enhanced CD8 positive T-cell response by directly conjugating an adjuvant to the candidate antigen. This expansion of our site-specific technology platform has the potential application in viral vaccines, where an enhanced CD8 T-cell response is required. I will now turn it over to Andrew for a financial update.

Earlier this month, we and our collaborators published the paper and scientific reports, where we demonstrated and enhance CDA positive T cell response.

And I directly conjugate and and adjuvant to the cat the antigen.

This expansion of our site specific technology platform has the potential application and viral vaccines, where and enhanced CD eight T cell responses required.

I will now turn it over to Andrew for a financial update.

Great. Thanks, Jeff.

Andrew L. Guggenhime: Before turning it over to Grant for some closing remarks, a few financial highlights. First, with respect to the income statement, the details of our fourth quarter and year-end 2020 results are reflected in our press release and 10-K filing, along with a key variance driver. In summary, the year-over-year increase in R&D expenses was primarily a function of the advancement of our Vax24 program, while the increase in G&A expenses was driven primarily by our transition to public company status and our overall growth.

Andrew Guggenhime: Great. Thanks, Jeff. Before turning it over to Grant for some closing remarks, a few financial highlights. First, with respect to the income statement, the details of our Q4 and year-end 2020 results are reflected in our press release and 10-K filing, along with the key variance drivers. In summary, the year-over-year increase in R&D expenses was primarily a function of the advancement of our VAX-24 program, while the increase in G&A expenses was driven primarily by our transition to public company status and our overall growth. As we look forward, based on our plans to advance our pipeline programs led by VAX-24 and to increase the size of our organization to support these efforts, we expect R&D and G&A expenses to increase substantially over 2020 levels.

Before turning it over to grant for some closing remarks of few financial highlights first.

First with respect to the income statement the details of our fourth quarter and year end of 2020 results are reflected in our press release and 10-K filings along with the key variance drivers and summary, the year over year increase and R&D expenses was primarily a function of that'd be advancement of her back and 24 program while.

While the increase and G&A expenses was driven primarily by our transition to the public company status and our overall growth.

Andrew L. Guggenhime: As we look forward, based on our plans to advance our pipeline programs, led by Vax24, and to increase the size of our organization to support these efforts, we expect R&D and G&A expenses to increase substantially over 2020 levels. Second, as to the balance sheet and cash runway, we ended 2020 with a strong balance sheet with $386.2 million in cash and cash equivalents compared to $397 million as of the prior quarter end and up substantially from the prior year end due to the Series D and IPO financing during the year.

As we look forward based on our plans to advance our pipeline programs led by back to 24 and to increase the size of our organization to support. These efforts, we expect R&D and G&A expenses to increase substantially over 2020 levels.

Second as to the balance sheet and cash runway. We ended 2020 with a strong balance sheet with $386 2 million and cash and cash equivalents compared to $397 million as of the prior quarter and and up substantially from the prior year and due to the series D and IPO financings during the year.

Andrew Guggenhime: Second, as to the balance sheet and cash runway, we ended 2020 with a strong balance sheet, with $386.2 million in cash and cash equivalents, compared to $397 million as of the prior quarter end and up substantially from the prior year end due to the Series D and IPO financings during the year. Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through at least the completion and announcement of the top-line data from our Phase I/II clinical proof of concept study of VAX-24 in adults, which, we note, we expect between late 2022 and early 2023, and to continue to advance our pipeline of other vaccine candidates.

Going forward, we expect other balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through at least the completion and announcement of the topline data from our phase one two clinical proof of concept study of <unk> 24, and adults, which as noted we expect between late 2022, and early 2020 three and the <unk>.

Andrew L. Guggenhime: Going forward, we expect that our balance sheet will be sufficient to fund our operating expenses and capital expenditure requirements through at least the completion and announcement of the top-line data from our Phase 1-2 clinical proof-of-concept study of X24 in adults, which, as noted, we expect between late 2022 and early 2023, and to continue to advance our pipeline of other vaccine candidates. With that, I'll now turn the call back over to Grant for some closing remarks before we open up the line for Q&A. Grant?

To advance our pipeline of other vaccine candidates.

Andrew Guggenhime: With that, I'll now turn the call back over to Grant for some closing remarks before we open up the line for Q&A. Grant?

With that I'll now turn the call back over to grant for some closing remarks before we open up the line for Q&A Grant.

Thanks, Andrew our mission at backside as the improved global health by developing superior and novel vaccine designed to prevent or treat some of the most common and deadly infectious diseases worldwide and light of all of the external headwinds in 2020, our progress last year and the continued momentum this year represents substantial <unk>.

Grant Pickering: Thanks, Andrew. Our mission at Vaxcyte is to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. In light of all the external headwinds in 2020, our progress last year and the continued momentum this year represent substantial strides toward achieving our mission. I want to thank all of our employees and collaborators, including the team at Lonza, for persevering through a tremendously challenging moment in history. For the remainder of 2021, our primary areas of focus will be to deliver on our remaining VAX-24 IND-enabling milestones, invest in VAX-31 to maximize our PCV franchise optionality and value, advance VAX-A1 into IND-enabling activities, nominate the final vaccine candidate for VAX-PG, and advance our earlier stage discovery programs.

Rides toward achieving our mission I want to thank all of our employees and collaborators, including the team at <unk> for persevering through a tremendously challenging moment in history.

Grant E. Pickering: Thanks, Andrew. Our mission at Vaxcyte is to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. In light of all the external headwinds in 2020, our progress last year and the continued momentum this year represent substantial strides toward achieving our mission. I want to thank all of our employees and collaborators, including the team at Lonza, for persevering through a tremendously challenging moment in history.

For the remainder of 2021, our primary areas of focus will be to deliver on our remaining <unk> 'twenty for India, enabling milestones invest and vacs XP to maximize our PCB franchise optionality and value.

Advanced vaccine one into IND, enabling activities nominate the final vaccine candidate for box P. G and advance our earlier stage discovery programs.

Grant E. Pickering: For the remainder of 2021, our primary areas of focus will be to deliver on our remaining Vax24 IND-enabling milestones, invest in VaxXP to maximize our PCB franchise optionality and value, advance Vax A1 into IND-enabling activities, nominate the final vaccine candidate for Vax PG, and advance our earlier stage discovery program. With that, I want to thank you all again for joining us today and your continued interest in Vaxc Before we close our prepared remarks, I'd like to thank Kurt von Emster, who previously held the position of our board chair, for agreeing to serve in this role on an interim basis as we initiate a search for a permanent board chair.

With that I want to thank you all again for joining us today and your continued interest and back site before we close our prepared remarks I'd like to thank per financed or who previously and held the position of our board chair for agreeing to serve and this role on an interim basis as we initiate the search for a permanent board chair, we look forward to your questions.

Grant Pickering: With that, I want to thank you all again for joining us today and your continued interest in Vaxcyte. Before we close our prepared remarks, I'd like to thank Kurt von Emster, who previously had held the position of our board chair, for agreeing to serve in this role on an interim basis as we initiate a search for a permanent board chair. We look forward to your questions today and to speaking with you in the weeks and months ahead. Operator?

Today, and speaking with you and the weeks and months ahead operator.

Thank you.

Operator 3: Thank you. Ladies and gentlemen, if you wish to register for a question for today's question and answer session, you will need to press star followed by the one key on your touchtone telephone. If your question has been answered and you wish to withdraw your polling request, you may do so by pressing the pound key. If you are using a speakerphone, please pick up your handset before entering your request. One moment please for our first question. Our first question comes from the line of Jason Gerberry with Bank of America. Your line is now open.

Operator: Thank you. Ladies and gentlemen, if you wish to register for a question for today's question and answer session, you will need to press star followed by the one key on your touch-tone telephone. If your question has been answered and you wish to withdraw your polling request, you may do so by pressing the pound key. If you are using a speakerphone, please pick up your handset before entering your request. One moment please for our first question. Our first question comes from the line of Jason Gerberry with Bank of America. Your line is now open.

And ladies and gentlemen, if you wish to register for a question for todays question and answer session. You would need the press star followed by the one key on your Touchtone telephone.

If your question has been answered any of western withdraw your of pulmonary request.

Grant E. Pickering: We look forward to your questions today and to speaking with you in the weeks and months ahead. Thank you. Ladies and gentlemen, if you wish to submit a question for today's question and answer session, you will need to press star followed by the one key on your touchtone telephone.

You may do so by pressing the pound king and for you.

I using a speakerphone please pick up your handset before entering your request.

One moment, please while first question.

Our first question comes from the line of Jason Garbarini with Bank of America. Your line is now open.

Operator: If your question has been answered and you wish to withdraw your...

Jason Gerberry: Hi, guys. Thank you for taking my questions. Can you remind us, apologies if I missed this, but how many of the conjugated drug substances has Lonza successfully completed? Just trying to get a sense of where you're at in that process and ultimately the range of outcomes for timing of IND submission. I think it's like 6 months. Can you give us a sense of what are the key variables that drive that range ultimately? I assume it's not the GLP tox study. I assume that's probably pretty straightforward once you complete some of the other steps along the process. If you can also just remind us how long the stability testing is? Thanks.

Hi, guys. Thank you for taking my questions.

Operator: You may do so by pressing...

Can you remind us.

Operator: If you are using a speakerphone, please pick up your handset before pressing the power key.

And I apologize if I missed this but how many of the conjugate the drug substances have Monza successfully completed just trying to get a sense of where you're at and that process and.

Operator: Please pick up your handset before entering your request. One moment, please, for our first question.

Operator: Our first question comes from the line of Jason Gerberry with Bank of America. Your line is now open. Hi guys, thank you for taking my questions. Can you remind us, apologies if I missed this, but how many conjugated drug substances has MONZA successfully completed?

And ultimately the the range of outcomes for timing of our IND submission and I think it's like six months.

Can you give us a sense of what are the key variables that drive that range ultimately I assume its not the G. L. P. Tox study ice and Thats, probably pretty straightforward. Once you complete some of the other steps along the process and and if you could also just remind us how long the stability testing is thanks.

Operator: [inaudible]

Operator: Ultimately, the range of outcomes for the timing of IND submission, I think it's like six months.

James Wassil: [inaudible] Yeah, hey, Jason, thank you for that question. So, you know, as we mentioned in the prepared remarks, this DS campaign consists of three different stages. So we've completed those first two stages, and as you say, we're now in the process of making the 24 conjugates themselves. You know, we're going to stay away from getting into full specificity as to the number that we've made, but I would characterize it as being well on our way to having made 24.

Yeah, Hey, Jason and thank you for that question.

Andrew Guggenhime: Yeah. Hey, Jason. Thank you for that question. You know, as we mentioned, in the prepared remarks, this DS campaign consists of three different stages. We've completed those first two stages, and as you say, we're now in the process of making the 24 conjugates themselves. You know, we're gonna stay away from getting into full specificity as to the number that we made, but I would characterize it as being well on our way to having made the 24. Ultimately, we'll only be able to declare victory once we've made all 24 of those and they pass all of the analytical tests required that meet our critical quality attributes.

Grant Pickering: Yeah. Hey, Jason. Thank you for that question. You know, as we mentioned, in the prepared remarks, this DS campaign consists of three different stages. We've completed those first two stages, and as you say, we're now in the process of making the 24 conjugates themselves. You know, we're gonna stay away from getting into full specificity as to the number that we made, but I would characterize it as being well on our way to having made the 24. Ultimately, we'll only be able to declare victory once we've made all 24 of those and they pass all of the analytical tests required that meet our critical quality attributes.

So you know as we mentioned in the prepared remarks. This D. S campaign consists of three different stages. So we've completed those first two stages and as you say, where we're now and the process of making the the twenty-four conjugates themselves.

We're going ahead, and we're going to stay away from getting into full specificity as to the number that we've made but I would characterize it as being well on our way to having made the 24 and ultimately will only be able to declare a victory. Once we've made all 24 of those and they pass all of the the analytical tests required.

James Wassil: And ultimately, we'll only be able to declare victory once we've made all 24 of those and they pass all of the analytical tests required to meet our critical quality attributes. So, you've got it exactly right. The GLPTOC study is already underway, and we don't expect that to be rate-limiting.

And that meet our critical quality attributes.

Grant Pickering: You've got it exactly right. The GLP tox study is already underway. We don't expect that to be rate limiting. The deliverables that are going to actually result in the ultimate IND submission timing are this completion of the DS conjugates and them being formally released. We have to make them and then complete that battery of analytical tests. Once we complete that will allow us to follow through with the drug product campaign to make each of the three different doses that we'll take into the clinical study. Of course, there'll be an analytical series of tests that are run on those in order to declare victory there. As it relates to the stability, we've already put the tox lots of the drug substances and the DP on stability.

You.

You got it exactly right. The the G. O P. Tox study is already underway, we don't expect that to be rate limiting and so the deliverables that are going to actually result, and the ultimate I and D submission timing or this completion of the the D S conjugates and them being formally released so.

James Wassil: So, the deliverables that are going to actually result in the ultimate IND submission timing are this completion of the DS conjugates and their formal release. So, we have to make them and then complete that battery of analytical tests. Once we complete that, that will allow us to follow through with the drug product campaign to make each of the three different doses that we'll take into the clinical study. And then, of course, there'll be an analytical series of tests that are run on those in order to declare victory there.

We have to make them and then complete that battery of analytical task. Once we complete that that will allow us to follow through with the drug product campaign to make each of the three different doses that will take into the clinical study and then of course there'll be a and analytical a series of tests that are.

Run on those in order to declare victory there and then as it relates to the stability we've already put the tox lots of the drug substances and the D. P. On stability. So those lead lots of stability studies have already started and then what we'll need to deliver with regard to the stability.

James Wassil: And then, as it relates to stability, we've already put the TOCS lots of the drug substances and the DP on stability. So those lead lot stability studies have already started, and then what we'll need to deliver with regard to stability, ultimately to permit the IND filing, Jim, correct me if I get this wrong. I think it's one month of stability, but Jim, you should correct me if I'm off on that. That's correct. Jason, this is Andrew.

Grant Pickering: Those lead lot stability studies have already started. What we'll need to deliver with regard to the stability, ultimately to permit the IND filing, Jim, correct me if I get this wrong, I think it's one month stability. Jim, you should correct me if I'm off on that.

The ultimately to permit the IND filing at Jim Correct Me, if I get this wrong I think it's one month stability, but Jim you should correct me if I'm off on that.

Jim Wassil: No, that's correct.

No that's correct.

And Jason This is Andrew I'll make just try and mid to your question about kind of the range of of the guidance. We've provided you know as we talked about kind of these process related adjustments are really R. R.

Andrew L. Guggenhime: Let me just chime in to your question about the kind of range of the guidance we've provided. We talked about these process-related adjustments being expected and standard in the course of drug development, and as we look forward at this point, if we see, and we expect them going forward, fewer than we expect, that would put us in a position of delivering the IND submission at the early end of the range, so-called early part of 2022. If we see more than we anticipate, that would put us at the back end of the range, so that's the rationale for the window we've provided.

Andrew Guggenhime: Jason, this is Andrew. I'll maybe just chime in to your question about kind of the range of the guidance we've provided. You know, as we talked about, kind of these process-related adjustments are really expected and standard in the course of drug development. As we look forward at this point, you know, we expect them going forward, if we see fewer than we expect, that would put us in a position of delivering the IND submission at the early end of the range, so-called the early part of 2022. If we see more than we anticipate, that will put us at the back end of the range. That's the rationale for the window we've provided.

Spectre and standard in and of course of drug development and as we look forward at this point.

If we see and we expect them going forward, if we see fewer than we expect that would put us in a position of delivering and the IND submission at the early and of the range. So call. It the early part of 2020 two if we see more than we anticipate that will put us in the back of and the back end of the range. So that's the the rationale for the window we provided.

Operator: Got it. Okay. Thank you.

Jason Gerberry: Got it. Okay. Thank you.

Got it okay. Thank you.

Yeah.

Thank you on that.

Operator 3: Thank you. Our next question comes from the line of Biren Amin with Jefferies. Your line is now open.

Operator: Thank you. Our next question comes from the line of Biren Amin with Jefferies. Your line is now open.

Operator: Our next question comes from the line of Barrett.

Next question comes on the line of Baron of Me with Jefferies. Your line is now open.

Operator: on the line with Baron Amin with Jeffries. Your line is now open.

Operator: Yeah, guys, thanks for taking my questions. Maybe just one on VAX-24. Clearly, if you're at the back end of the range in June 2022 for IND, you know, and your guidance for top line data is late 2022, early 2023, how feasible is that early 2023 timeframe?

Yeah, Hi, guys. Thanks for taking my questions, maybe just one on vacs 'twenty for.

Biren Amin: Yeah. Hi, guys. Thanks for taking my questions. Maybe just one on VAX-24. Clearly, if you're at the back end of the range, in June 2022 for IND, you know, and your guidance for top line data, late 2022, early 2023, how feasible is that early 2023 timeframe?

Clearly if you're at the back end of the range and June 'twenty 'twenty two for I D.

You know and and your guidance for top line data.

Late 2020 two early 2020 three how feasible is that early 2023 time frame.

Andrew L. Guggenhime: Yeah, go ahead, Andrew. Yeah, I was going to say that the top-line data range, Barron, generally corresponds with the IND application submission range. So if we're in a position to deliver the IND application submission in the early part of 22, we believe that would put us in the position of having top-line data by the end of the year. If, alternatively, we're at the back end of the IND application submission range and call it Q2 up to June 22, in that scenario, we're more likely to have data in the early part of 2023.

Yeah, I think yeah go ahead, Andrew Yeah. It was kind of say the the the topline data range Baron generally corresponds with the IND application submission range. So for in a position to deliver the ion the application submission and the early part of 'twenty. Two we believe that would put us in the position of having.

Grant Pickering: Yeah, I think.

Andrew Guggenhime: Yeah, I think.

Grant Pickering: Yeah, go ahead, Andrew.

Andrew Guggenhime: Yeah, I was gonna say the top line data range, Biren Amin, generally corresponds with the IND application submission range. If we're in a position to deliver the IND application submission in the early part of 2022, we believe that would put us in the position of having the top line data by the end of the year. If alternatively, we're at the back end of the IND application submission range in, you know, call it Q2 up to June 2022, in that scenario, we're more likely to have data in the early part of 2023.

The topline data by the end of the year, if alternatively, where at the back end of the IND application submission range and you know call. It Q2 up to June 22, and that scenario, we're more likely to have data and the early part of 2023.

Operator: Okay, and then I guess a question on VaxXP. So congratulations on the progress there. Can you just maybe talk about it?

Biren Amin: Okay. I guess a question on VAX-31. So congrats on the progress there. Can you just maybe talk about, you know, read-throughs that you can take on VAX-24 manufacturing to the XpressCF program and whether manufacturing can be expedited as a result of key learnings that you've made on VAX-24?

Okay, and then I guess a question on Vacs XP.

And so congrats on the progress there can you just maybe talk about you know read throughs that you can take on vacs 'twenty for manufacturing to the XP program and why the manufacturing can can be expedited and as a result of key learnings that you've made on vacs 'twenty for.

Operator: read-throughs that you can take on Vax24 manufacturing to the XP program and whether manufacturing can

Grant E. Pickering: Yeah, thanks, Barron. Yeah, we're really excited about the Vax XP data. Obviously, this just further shows the sort of scalability that the platform can deliver with regard to the spectrum of coverage, and we all know that's been the key adoption feature in this market.

Yeah, Thanks parent.

Grant Pickering: Yeah. Thanks, Baran. Yeah, we're really excited about the VAX-24 data. Obviously, this just further shows the sort of scalability that the platform can deliver with regard to the spectrum of coverage. You know, we all know that's been the key adoption feature in this market. Very encouraged with this immunogenicity data. Just to, you know, put a slightly finer point on it. The incremental conjugates that are on top of VAX-24 that were included in this study, these are conjugates that were made at Lonza. These are conjugates that were made at a substantially larger scale than we had produced previously here at Vaxcyte. This is a 15-fold scale up akin to what we had done with VAX-24.

Yeah, we're really excited about the Vacs X P data and obviously this just further shows the sort of scalability that the platform can deliver with regard to the spectrum of coverage and we all know that spend the the key adoption feature in this market. So very encouraged with this immunogenicity data and just to.

Grant E. Pickering: So very encouraged with this immunogenicity data. And just to put a slightly finer point on it, so the incremental conjugates that are on top of Vax24 that were included in this study, these are conjugates that were made at Lonza. These are conjugates that were made at a substantially larger scale than we had produced previously here at Vaxcyte. So this is a 15-fold scale up akin to what we had done with Vax24.

You know put of a slightly finer point on it so the incremental.

And conjugates that are on top of <unk> 'twenty for our.

Debt were included in this study. These are conjugates that were made at launch. The these are conjugates that were made at a substantially larger scale than we had produced previously here at back site. So this is the 15 fold scale of akin to what we had done with vacs 'twenty for.

Grant E. Pickering: So it's very encouraging to see the consistency of the immunogenicity across those incremental strains. But then I would also point out the 24 conjugates that were included that are in VaxXP that are also in Vax24; these were the conjugates that we made in the TOX batch that we made at Lonza that went into the non-clinical TOX study. So, you know, we're seeing this continued immunogenicity across, you know, now over 30 conjugates, but another data point with the 24 that are in Vax24 that look really encouraging and show, you know, non-inferiority relative to all of the strains in Prevnar and then certainly superior immune responses to polysaccharide only, including all 23 that are in Pneumovax and then obviously quite a number beyond

Grant Pickering: It's very encouraging to see the consistency of the immunogenicity across those incremental strains. I would also point out the 24 conjugates that were included that are in VAX-24 that are also in VAX-24. These were the conjugates that we made in the tox batch that we made at Lonza that went into the non-clinical tox study. You know, we're seeing this continued immunogenicity across, you know, now over 30 conjugates, but another data point with the 24 that are in VAX-24 that look really encouraging and show, you know, non-inferiority relative to all of the strains in Prevnar, and then certainly superior immune responses to polysaccharide only, including all 23 that are in Pneumovax, and then obviously quite a number beyond that.

So it's very encouraging to see the consistency of the immunogenicity across those incremental strains, but then I would also point out. The 24 conjugates that were included that our Inbox X P. That are also in Vaca 20 for these were of the conjugates that we made in the Tox batch that we made at launch.

And that went into the non clinical Tox study. So we're seeing this continued immunogenicity across now over 30 conjugates, but another data point with the 'twenty for that our inbox 'twenty for that look really encouraging and show non inferiority relative to all of the strains and prep and our and.

And then certainly superior immune responses to polysaccharide only.

Including all of 23 that are and Pneumovax and then obviously quite a number beyond that.

Grant E. Pickering: And when can we expect the IND for the X phase? You know, it's too early.

And when can we expect the eye and D for ex fee.

Biren Amin: When can we expect the IND for XP?

You know, it's it's too early to say what that timing is going to look like for that beer and you know, it's kind of pivot off the ultimate timing for the Vacs 20 for I D.

Grant E. Pickering: You know, it's too early to say what that timing is going to look like for that, Baron. It's going to pivot off the ultimate timing for Vax24 IND. You know, we're also going to key off the epidemiological data and the demand for some of these incremental strains that we're already seeing becoming more and more important. But as that data evolves, that's also going to guide us. And to a lesser extent, you know, we're obviously going to be monitoring the competition as well.

Grant Pickering: You know, it's too early to say what that timing is gonna look like for that, Biren. You know, it's gonna pivot off the ultimate timing for the VAX-24 IND. You know, we're also gonna key off the epidemiological data and the demand for some of these incremental strains that we're already seeing them becoming more and more important. As that data evolves, that's also gonna guide us. To a lesser extent, you know, we're obviously gonna be monitoring the competition as well. For us, VAX-24 is the fastest path to the market. Those 24 strains are really the most important strains that we need to get a solution out there as soon as practicable.

We're also going to key off the the epidemiological data and the demand for some of these incremental strains that we were already seeing them, becoming more and more important.

But as that data evolves, that's also going to guide us and to a lesser extent, we're obviously going of be monitoring and the competition as well but for us the.

Grant E. Pickering: But for us, Vax24 is the fastest path to the market. Those 24 strains are really the most important ones that we need to get a solution out there as soon as practicable. And you know, we think that it is going to be very competitive relative to the other PCBs that are in development. And we believe that this would put Vax24 in a position to not only be the broadest spectrum PCB but the one that would enable the withdrawal of Pneumovax23 from continued use, which would open the door to a prime boost in adults where it would really be valuable for older adults to get that second, significantly higher boost to create longer-lasting protection.

<unk> 20 for is the fastest path to the market.

24 strains are really the most important strains that we need to get a solution out there as soon as practicable.

Grant Pickering: you know, we think that is going to be very competitive relative to the other PCVs that are in development. We believe that this would put VAX-24 in a position to not only be the broadest spectrum PCV, but the one that would enable the withdrawal of Pneumovax 23 from continued use, which would open the door for a prime boost in adults, where it would really be valuable for older adults to get that second significantly higher boost to create longer lasting protection.

And we think that that is going to be very competitive relative to the other pcbs that are in development and we believe that this would put backs 24 and are positioned to not only be the broadest spectrum P. C b, but the one that would enable the withdrawal of Pneumovax 23 from continued use which would.

Open the door for of Prime boost and adults, where it would really be valuable for older adults to get that second significantly higher boost to create longer lasting protection.

Great. Thank you.

Operator: Great, thank you. Yeah, thanks, Baron. Thank you. Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.

Biren Amin: Great. Thank you.

Grant Pickering: Yeah. Thanks, Biren.

Yeah. Thanks Burton.

Thank you. Our next question comes on the line of Omar with that with Evercore. Your line is now open.

Operator 3: Thank you. Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.

Operator: Thank you. Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.

Operator: with Evercore. Your line is now open. Boomer.

Yes.

Omar for you there.

Grant Pickering: Umer, are you there?

If your phone is the new please on mute your line.

Operator: If your phone is on mute, please unmute your line. Bye. There, should we move on to the next question? Of course. Our next question...

Operator 3: Our next question comes.

Operator: Our next question comes.

And there should we move onto the next question.

Grant Pickering: Sarah, should we move on to the next question?

Certainly our next question comes on the line of Louise Chen with Cantor Fitzgerald. Your line is now open.

Operator 3: Certainly. Our next question comes from the line of Louise Chen with Cantor Fitzgerald. Your line is now open.

Operator: Certainly. Our next question comes from the line of Louise Chen with Cantor Fitzgerald. Your line is now open.

Operator: comes from the line of Louise Chen with Cantor Fitzgerald. Your line is now open. Hi. Congratulations on all the progress during the quarter, and thanks for taking my questions here.

Louise Chen: Hi. Congratulations on all the progress during the quarter, and thanks for taking my questions here. I had a few. First question I had is, how do you think ACIP will update its guidelines as new PCVs get introduced? There are going to be two new ones likely in the near term, and then yours and others to follow that with broader coverage. Do you think pricing is going to be a factor here? The second thing I want to ask you is just, do you think COVID changes the importance of PCVs for patients? How have doctors felt about that you've spoken with? The last question I had for you is just on OpEx for 2021.

Hi, congratulations on the all the progress during the quarter and thanks for taking my questions here side of it.

Operator: So I had a few. The first question I had was, how do you think?

Your first question I had is how do you think ACF well updated its guidelines and new P. C vs get introduced and Theyre going to be two new ones likely and the near term and then yours and others to follow that with broader coverage. You do you think pricing is going to be a factor here and then the second thing was to ask you was just do you think cove.

Operator: ASIP will update its guidelines as new PCVs get introduced. There are going to be two new ones in the near term, and then yours and others will follow that with broader coverage. Do you think pricing is going to be a factor here? And then the second thing I wanted to ask you was, do you think COVID changes the importance of PCVs for patients? How have the doctors felt about that that you've spoken with felt about it?

It changes the importance of P. C vs for patients how doctors felt about that the ive spoken with and then last question I had for you is just on Opex for 2021, and you talked about a substantial increase and and I know you gave some guidance on how long of cash runway goes out until but maybe if you could just give us a little bit more color on on.

Operator: And the last question I have for you is just on OPEX for 2021. You talked about a substantial increase, and I know you gave some guidance on how long your cash runway goes out until, but maybe if you could just give us a little bit more color on what qualifies for substantial in your mind, and then that breakout between R&D and SG&A, how should we think about that? Thank you.

Louise Chen: You talked about a substantial increase, and I know you gave some guidance on how long your cash run rate goes out until, but maybe if you could just give us a little bit more color on what substantial, you know, what qualifies for substantial in your mind, and then that breakout between R&D and SG&A, how should we think about that? Thank you.

What substantial you know what qualifies for substantial in your mind and then the breakout between R&D and SG&A, how should we think about that thank you.

Grant E. Pickering: Yeah, great. Thanks, Louise.

Grant Pickering: Yeah, great. Thanks, Louise. I heard three questions, essentially. I'll take one, I'll pass the other to Jim, and then Andrew will comment on the financials. Maybe I can just start with the COVID-related question before Jim, who is our resident ACIP expert, comments on how we expect some of these other PCVs to impact the market. Certainly as we think about greater risk associated with circulating COVID, especially with the variants in older adults, you know, I think it clearly, you know, shows the importance of having more broad vaccination with the pneumococcal vaccines that are out there. We saw that very early on as the pandemic took hold last year. The rate of vaccination in Europe and even in the US was up substantially.

Yeah, great. Thanks, Louise So sorry, I heard three questions are essentially I'll take one I'll pass the other to Jim and then Andrew will will will comment on the financials, but maybe I can just start with the Covid related question before Jim who is our resident and ACI P expert comments on how we expect.

Grant E. Pickering: So I heard three questions, essentially. I'll take one, I'll pass the other to Jim, and then Andrew will comment on the financials. But maybe I can just start with the COVID-related question before Jim, who is our resident ACIP expert, comments on how we expect some of these other PCBs to impact the market. But certainly, as we think about the greater risk associated with circulating COVID, especially with the variants in older adults, you know, I think it clearly shows the importance of having more broad vaccination with the pneumococcal vaccines that are out there.

Some of these are the other pcbs to impact the market, but certainly as we think about a greater risk associated with circulating COVID-19, especially with the variance in older. Adults I think it clearly shows the importance of having more broad.

And vaccination with the pneumococcal vaccines that are out there and we saw that very early on as the pandemic took hold last year.

Grant E. Pickering: And we saw that very early on as the pandemic took hold last year. The rate of vaccination in Europe and even in the U.S. was up substantially, prior to people sheltering and having poor access to physicians.

The the rate of vaccination in Europe, and even in the U S was up substantially.

Grant Pickering: That was prior to people sheltering and having poorer access to physicians. As we know, these viral pandemics usually result in weakened immune systems in older adults, which allows them to fall prey to, you know, existing bacteria. Strep pneumonia is precisely, you know, the bacteria that you'd be worried about. I think this is only going to increase the rate of vaccination in adults with pneumococcal vaccines and is going to put additional pressure on the spectrum of coverage that's available to create protection for what's clearly a preventable infection. Yeah, I think it only is going to have a positive impact on the pneumococcal vaccine space as a business and as, you know, a societal benefit.

And that was prior to people sheltering and and having poor access to physicians, but as we know these these viral pandemics, usually result, and weakened immune systems and older adults, which allows them to fall prey to <unk>.

Grant E. Pickering: But as we know, these viral pandemics usually result in weakened immune systems in older adults, which allows them to fall prey to existing bacteria, and strep pneumonia is precisely the bacteria that you'd be worried about. So I think this is only going to increase the rate of vaccination in adults with pneumococcal vaccines and is going to put additional pressure on the spectrum of coverage that's available to create protection for what's clearly a preventable infection.

Existing bacteria and strep pneumonia is precisely the bacteria that you'd be worried about so I think this is only going to increase the rate of vaccination in adults with pneumococcal vaccines and it's going to put additional pressure on the spectrum of coverage.

That's available too to the.

To create protection for what's clearly a preventable infection. So yeah I think it only is going to have a positive impact on the pneumococcal vaccine and a spa.

Grant E. Pickering: So yeah, I think it's only gonna have a positive impact on the pneumococcal vaccine space as a business and as, you know, a societal benefit. With that, let me hand it to Jim to make some comments about the ACIP, and then we'll hand it to Andrew. Jim? Thank you.

As a business and as you know of societal benefit.

Grant Pickering: With that, let me hand it to Jim to make some comments about the ACIP, and then we'll hand it to Andrew. Jim?

With that let me hit at the gym to make some comments about the ACI P. And then we'll hand it to Andrew Jim.

Grant Pickering: With that, let me hand it to Jim to make some comments about the ACIP, and then we'll hand it to Andrew. Jim?

Jim Wassil: Thanks, Grant. Louise, when you looked at the February ACIP presentations on pneumococcal vaccines, they did outline basically what they think they're going to do. With the June ACIP, they're going to review cost effectiveness and do their evidence recommendation and their grading. They think that if the products are licensed, that they potentially could have a vote in October. When you know, try and figure out what it is that they're going to make in terms of a recommendation, they made a list of policy questions that are under consideration by the working group, as well as questions with regard to what they need to evaluate from a health economic perspective. I think that gives us some insight into where they're going.

Thanks Grant and Louise when when you looked at the February the ACI P presentations on the pneumococcal vaccines and they did outline basically what they think they're going to do with the G&A CIP theyre going to redo cost effectiveness and do their evidenced recommendation and the grading and they think that it's the <unk>.

James Wassil: Thanks, Grant. So, Louise, when you looked at the February ACIP presentations on pneumococcal vaccines, they did outline basically what they think they're going to do. With the June ACIP, they're going to review cost-effectiveness and do their evidence-to-recommendation and their grading, and they think that if the products are licensed, they could potentially have a vote in October when they try and figure out what it is that they're going to make in terms of a recommendation.

Alex or license that they potentially could have a vote and October.

When you.

Try and figure out what it is that theyre going to make in terms of our recommendation.

James Wassil: They made a list of policy questions that are under consideration by the working group as well as questions with regard to what they need to evaluate from a health economic perspective. And I think that gives us some insight into where they're going.

They made a list of policy questions that are under consideration by the working group as well as questions with regard to what they need to evaluate from of health economic perspective, and I think that gives us some insight into where they're going on.

James Wassil: They are asking the question, should PCV 15 or 20 be given at age 50 and above or 65 years of age and above? So they are potentially considering lowering the age of recommendation down to 50. I think they'll keep 65, but it is interesting that they are considering lowering that to 50. They also asked if PCV15 or PCV20 should be recommended in younger adults with underlying medical conditions. I do think that they will recommend PCVs for the 18-49 or 18-65 age group that have certain pre-existing conditions.

Jim Wassil: They are asking the question, should PCV15 or PCV20 be given at age 50 and above or 65 years of age and above? So they are potentially considering lowering the age of recommendation down to 50. I think they'll keep 65, but it is interesting that they are considering lowering that to 50. They also asked if PCV15 or PCV20 should be recommended in younger adults with underlying medical conditions. I do think that they will recommend PCVs for the 18 to 49 or 18 to 65 age group that have certain preexisting conditions. Finally they ask, you know, should they give PCV15 and PCV20 alone or in a series with Pneumovax 23? And all indications are pointing towards they will continue with giving the PCVs.

They are asking the question should PCV 15, or 20 be given and age 50 and above or 65 years of age and above so they are potentially considering to lowering the age of the recommendation down to 50, I think they'll keep 65, but it is interesting that the art considering lowering net to 50 the.

So asked if the P. C D 15 or piece of the 'twenty should be recommended and younger adults with underlying medical conditions I do think that they will recommend pcbs.

For the 18 to 49 or 18 to 65 age group that have certain preexisting conditions and.

James Wassil: Then finally, they ask, you know, should they give PCV 15 and 20 alone or in series with PPSV 23? And all indications are pointing to them continuing to give the PCVs first and then a year later with PPSV 23 to ensure that they get the breadth of cover. We're hoping, of course, with 24, covering all of the same strains in PCV 13, well, or 15 and 20, as well as PCV 23, that ultimately we can reduce the number of shots and not have to do that series going forward. And Andrew, I guess you can answer the financial questions.

Finally, they ask you know should they give piece of the 15 and 20 alone or in a series with Pneumovax 23 and.

And all indications are pointing towards day will continue with.

And with giving the P C vs per.

Grant Pickering: First, then a year later with PPSV23 to ensure that they get the breadth of coverage. We're hoping, of course, with 24 covering all of the same strains in PCV13, well, or 15 and 20, as well as Pneumovax 23, that ultimately we can reduce the number of shots and not have to do that series going forward. Andrew, I guess you can answer the financial questions.

Jim Wassil: First, then a year later with PPSV23 to ensure that they get the breadth of coverage. We're hoping, of course, with 24 covering all of the same strains in PCV13, well or 15 and 20, as well as Pneumovax 23, that ultimately we can reduce the number of shots and not have to do that series going forward. Andrew, I guess you can answer the financial questions.

And then a year later with P. P S be twenty-three to ensure that they get the breadth of coverage.

And we're hoping of course with 20 for covering all of the same streams and Ptv 13, well for 15 and 20 as well as Pneumovax 23 of that ultimately we can.

Reduced the number of shots and not have to do that series going forward.

Andrew L. Guggenhime: Sure. Thanks, Jim.

And and Andrew what gets you can eat through the financial questions.

Andrew L. Guggenhime: Louise, yes, you're correct. We did not provide point estimates or range estimates for 2020-2021 operating expenses other than to say, as you noted, we expect both G&A and R&D expenses to increase substantially. I guess a couple of data points I would offer, as you think about that, that hopefully will be helpful.

Andrew Guggenhime: Yeah, no, sure. Thanks, Jim. Louise, yes, you're correct. We did not provide point estimates or range estimates for 2021 operating expenses other than to say, as you noted, we expect both G&A and R&D expenses to increase substantially. I guess a couple of data points I would offer as you think about that, hopefully will be helpful. You know, our G&A expenses over the course of 2020 increased quarter over quarter as we continued to build our organization, obviously upon the transition to a public company in June, where we saw the effect of things like D&O insurance expenses and higher stock-based compensation levels. We do expect year over year, 2021 compared to 2020, to see a substantial increase in G&A.

Yeah, No sure. Thanks, Jim Louise Yes, you're correct, we did not provide a point estimates or range estimates for 2020 'twenty, one operating expenses other than to say as you noted we expect both G&A and R&D expenses to increase substantially I guess of couple of data points I would offer as you as you think about that that hopefully will be helpful.

Andrew L. Guggenhime: Our G&A expenses... over the course of 2020 increased quarter over quarter as we continued to build our organization and, obviously, upon the transition to a public company in June where we saw the effect of things like D&O insurance expenses and higher stock-based compensation levels. We do expect, year over year, 21 compared to 20, to see a substantial increase in G&A. I think that increase, if you look at annualized Q4 of 2020, that increase is far more modest because we've largely built out that which is required to support our public company status.

And our G&A expenses.

Over the course of 2020 increased quarter over quarter as we continued to build our organization and obviously upon the transition.

Two of public company and June where we saw the effect of things like D&O insurance expenses and higher stock based compensation levels. We do expect year over year 21, compared to 20 to see a substantial increase in G&A I think that increase if you look at annualized Q4 of 2020 that increase was far more modest because we've largely built out.

Andrew Guggenhime: I think that increase, if you look at annualized Q4 of 2020, that increase is far more modest because we've largely built out kind of that which is required to support our public company status. Relative to Q4 annualized, more modest growth. From an R&D perspective, it's a very different story. Unlike G&A, which kinda grows sequentially quarter to quarter, R&D expenses are far more volatile and fluctuate just given the nature of the underlying principally manufacturing activity. Depending on where we are, for example, with Lonza in the midst of a manufacturing campaign, or we've moved to testing phase, that very much dictates the flow of R&D expenses. Year over year, again, expecting a substantial increase.

Andrew Guggenhime: I think that increase, if you look at annualized Q4 of 2020, that increase is far more modest because we've largely built out kind of that which is required to support our public company status. Relative to Q4 annualized, more modest growth. From an R&D perspective, it's a very different story. Unlike G&A, which kinda grows sequentially quarter to quarter, R&D expenses are far more volatile and fluctuate just given the nature of the underlying principally manufacturing activity. Depending on where we are, for example, with Lonza in the midst of a manufacturing campaign or we've moved to testing phase, that very much dictates the flow of R&D expenses. Year over year, again, expecting a substantial increase.

And kind of that which is required to support of public company status. So relative to Q4 annualized more modest growth from an R&D perspective, very different story of unlike G&A, which kind of growth sequentially quarter to quarter R&D expenses are far more volatile and fluctuate just given the nature of the underlying principally manufacturing activity. So depending on where we are for example.

Andrew L. Guggenhime: So relative to Q4 annualized, more modest growth. But from an R&D perspective, it's a very different story. Unlike G&A, which kind of grows sequentially quarter to quarter, R&D expenses are far more volatile and fluctuate just given the nature of the underlying principally manufacturing activities. So depending on where we are, for example, with Lonza, in the midst of a manufacturing campaign, or we've moved to the testing phase, that can dictate and very much dictate the flow of R&D expenses.

With lines of in the midst of the manufacturing campaign and we've moved the testing phase that can dictate and very much dictates the flow of R&D expenses. So year over year are again expecting a substantial increase.

Andrew L. Guggenhime: So year over year, again, expecting a substantial increase. If you look at 2020, our peak R&D quarter was actually in the first quarter of 2020, just given the nature of activities that were occurring at that time. And we still expect a substantial increase in 2021 compared to the annualized R&D number in Q1. However, again, we expect that number to fluctuate more in 2021 just given the nature of the underlying activities over the course of the year. Okay, thank you. Actually, you broke up a little bit.

Andrew Guggenhime: If you look at 2020, our peak R&D quarter was actually in Q1 2020, just given the nature of activities that was occurring at that time. We still expect a substantial increase in 2021 compared to the annualized R&D number in Q1. Although again, we expect that number to fluctuate more in 2021, just given the nature of the underlying activities over the course of the year.

You look at 2000 2020, our peak R&D quarter was actually and the first quarter of 2020, just given the nature of activities that was occurring at that time, and we still expect the substantial increase in 2020, one compared to the annualized R&D number in Q1, although again, we expect that number to fluctuate more in 2020 one.

And just given the nature of the underlying activities over the course of the year.

Okay. Thank you actually if I you broke up a little of that when you said your peak R&D was which quarter.

Louise Chen: Okay, thank you. Actually, you broke up a little bit when you said your peak R&D was which quarter?

Andrew L. Guggenhime: a little bit when you said your R&D was in which quarter? Our peak R&D in 2020 was actually the first quarter.

Andrew Guggenhime: Our peak R&D in 2020 was actually the first quarter, just given the nature of the activities at that time, which were in eCRM and polysaccharide manufacturing activities. For 2021, we expect to see an increase over the annualized Q1 2020 level as well.

Our peak R&D in 2020 was actually the first quarter just given the nature of the activities that the that time, which were in E crem and polysaccharide manufacturing activities for 2021, we expect to see an increase.

Andrew L. Guggenhime: Our peak R&D in 2020 was actually the first quarter, just given the nature of the activities at that time, which were in e-creme and polysaccharide manufacturing activities. For 2021, we expect to see an increase over the annualized Q1 2020 level as well. Thank you. Our next question comes from the line of Joseph Stringer with Needham & Company.

Over the annualized Q1 2020 level as well.

Okay. Thank you very much.

Louise Chen: Okay, thank you very much.

Thank you our next.

Operator 3: Thank you.

Operator: Thank you.

Andrew Guggenhime: Thanks.

Operator 3: Our next question comes from the line of Joseph Stringer with Needham & Company. Your line is now open.

Operator: Our next question comes from the line of Joseph Stringer with Needham & Company. Your line is now open.

Our next question comes on the line of Joseph Stringer with Needham and company.

And is now open.

Hi, everyone. Thanks for taking my question just a few quick ones on back.

Joseph Stringer: Hi, everyone. Thanks for taking our question. Just a few quick ones on VAX-A1 and VAX-PG. Just, you've laid out some timelines for IND-enabling studies. When could it be possible that both of those could enter the clinic? And is there a preference for advancing either one of those programs at a faster pace or I guess a prioritization on one program over the other, or would they be sort of advanced in parallel fashion? Thank you.

Joseph Stringer: Hi, everyone. Thanks for taking our question. Just a few quick ones on VAX-A1 and VAX-PG. Just, you've laid out some timelines for IND-enabling studies. When could it be possible that both of those could enter the clinic? And is there a preference for advancing either one of those programs at a faster pace or I guess a prioritization on one program over the other or would they be sort of advanced in parallel fashion? Thank you.

Operator: Company. Your line is now open. Hi, everyone.

Back to you.

And then backs.

Operator: Thanks for taking our question. Just a few quick ones on VAX-A1 and VAX-BG. You've laid out some timelines for IND-enabling studies. Could it be possible that both of those could enter the clinic, and is there a preference for advancing either one of those programs at a faster pace or, I guess, a prioritization of one program over the other, or would they be sort of advanced in parallel fashion? Thank

Yes.

And laid out some sidelines for IND, enabling studies.

Could it be possible that both of those debt into the clinic and is there a preference for advancing either one of those programs at a faster pace or.

I guess the prioritization on one program over the other or would they be sort of advanced and and parallel fashion. Thank you.

Andrew L. Guggenhime: Great, Joey. This is Andrew. I'll take the first part and then maybe take a crack at the second with my colleagues to follow. I would say for each of the programs, Vax A1 and Vax PG, we are not at this moment providing IND guidance. As you heard in the prepared remarks for Vax A1, having nominated the final candidate in Q1, which was on our timeline, we expect to initiate IND-enabling activities in the second half of this year.

Great Joy. This is Andrew I'll take the first part of it and then maybe take a crack at the second with my colleagues to follow I would.

Andrew Guggenhime: Great, Joseph. This is Andrew. I'll take the first part, and then maybe take a crack at the second with my colleagues to follow. I would say for each of the programs, VAX-A1 and VAX-PG, we are at this moment not providing IND guidance. As you heard on the prepared remarks for VAX-A1, having nominated the final candidate in Q1, which was on our timeline, we expect to initiate IND-enabling activities in H2 this year. Among the activities included for VAX-A1 are the selection of a CMO partner and the determination of the CMC path forward. It really wouldn't be until that point where it would be prudent for us to set forth IND guidance. You should expect us to do that once we have a clear path with respect to the CMO partner.

And say for each of the programs back day, one and back to P. G. We are at this moment not providing any guidance as you heard on the on the prepared remarks for say one having nominated the final candidate and Q1, which was on our timeline, we expect to initiate IND, enabling activities and the second half of this year among the activities included for vaccine.

Andrew L. Guggenhime: Among the activities included for Vax A1 are the selection of a CMO partner and the determination of the CMC path forward. So it really wouldn't be until that point where it would be prudent for us to set forth IND guidance, but you should expect us to do that once we have a clear path with respect to the CMO partner. And then for Vax PG, it's a little further behind at the moment. We have yet to nominate our final candidate consistent with our previous timelines.

One are the selection of the CMO partner and the determinant of the CMC path forward. So it really it wouldn't be until that point, where it would be prudent for us to set forth and guidance, but you should expect us to do that once we have a clear path with respect to the CMO partner.

Andrew Guggenhime: VAX-PG is a little further behind at the moment. We have yet to nominate our final candidate, consistent with our previous timelines. We now expect to do so, in H2 of this year, again, consistent with what we'd previously outlined. At that point, much like I mentioned for VAX-A1, we would expect to select a CMO partner and a path forward, at which time we likely will be in a position to offer our IND guidance. I would say overall, and Jeff or Grant can comment just from a timeline standpoint, VAX-A1 is ahead, on the timeline, vis-à-vis VAX-PG, at least at this point in time.

And then for <unk> is the mobile further behind at the moment, we have yet to nominate our final candidates consistent with our previous timelines. We now expect to do so and the second half of this year again consistent with what we've previously outlined and then at that point much like I mentioned for <unk>. One we would expect to select the CMO partner and of power Board at.

Grant E. Pickering: We now expect to do so in the second half of this year, again, consistent with what we previously outlined. And then, at that point, much like I mentioned for Vax A1, we would expect to select a CMO partner and a path forward, at which time we will likely be in a position to offer our IND guidance. I would say overall, and Jeff or Grant can comment, just from a timeline standpoint, Vax A1 is ahead on the timeline vis-à-vis Vax PG, at least at this point in time. Yeah, hey, Joe, this is Grant Pickering.

Each time, we likely will be in a position to offer our eye in the guidance I would say overall and Jeff for grants and comment just from a timeline standpoint, that's a one is ahead.

On the timeline visa b back to <unk> at least at this point and time.

Yeah, and I I, Hey, Joe This is grant Pickering, I would chime in and just say that you know.

Grant Pickering: Yeah. Hey, Joseph, this is Grant Pickering. I would chime in and just say that, you know, VAX-A1 is ahead. It also has the benefit of a substantial offset from CARB-X, so there's a nice efficiency there. We're really excited about the data that we're seeing from that program. We're buoyed by the notion now that there's an opportunity to develop this vaccine as not only a potential addition to the pediatric regimen, but now it's having potential as an adult vaccine as well. Really excited about that program. The VAX-PG program, we think has huge potential as well. We're really not expecting to really pick one over the other. We're anticipating that we're gonna move both those programs forward based on the potential that they each bring to the company.

Grant E. Pickering: I would chime in and just say that, you know, A1 is ahead. It also has the benefit of a substantial offset from CARB-X, so there's a nice efficiency there. We're really excited about the data that we're seeing from that program. We're buoyed by the notion now that there's an opportunity to develop this vaccine as not only a potential addition to the pediatric regimen, but it now has potential as an adult vaccine as well. So we're really excited about that program.

A one is ahead and it also has the benefit of a substantial offset from carb X. So there's a nice efficiency there.

And we're really excited about the data that we're seeing from that program were buoyed by the the notion now that there's an opportunity to develop this vaccine is not only of potential addition to the pediatric regimen, but now it's having potential as an adult vaccine as well so really excited about that program.

And the Vacs P. G program, we think has huge potential as well so we're really not expecting to really pick one over the other we're anticipating that we're going to move both of those programs forward based on the potential that they each bring to the company. So so for now we're moving them along and were and are positioned to do that.

Grant E. Pickering: And the VaxPG program, we think it has huge potential as well, so we're not really expecting to pick one over the other. We're anticipating that we're going to move both those programs forward based on the potential that they each bring to the company.

Grant Pickering: For now, we're moving them along, and we're in a position to do that.

Grant E. Pickering: So for now, we're moving them along, and we're in a position to do that. Thank you. Thanks, Joey. Thank you. There are no further questions at this time.

Grant Pickering: For now, we're moving them along, and we're in a position to do that.

Thank you.

Joseph Stringer: Thank you.

Thanks Joey.

Grant Pickering: Thanks, Joseph.

Andrew Guggenhime: Thanks, Joseph.

Thank you there are no further questions at this time I would now like to turn the call back to Brian Pinkberry and for closing remarks.

Operator 3: Thank you. There are no further questions at this time. I would now like to turn the call back to Grant Pickering for closing remarks.

Operator: Thank you. There are no further questions at this time. I would now like to turn the call back to Grant Pickering for closing remarks.

Operator: I would now like to turn the call back to Grant Pickering for his closing remarks.

Grant E. Pickering: Yeah, thanks, Sarah. I'd just like to thank you all for your support of the company. We really appreciate you dialing in. Obviously, we're disappointed that we're not going to be able to hit the original IND guidance. We made huge strides last year, and we don't feel that there's anything in particular that is going to get in our way. There's a lot of operational activity required to deliver a vaccine like Vax24 at the level of complexity that we're looking at.

Grant Pickering: Yeah. Thanks, Sarah. I'd just like to thank you all for your support of the company. We really appreciate you dialing in. Obviously, we're disappointed that we're not going to be able to hit the original IND guidance. We made huge strides last year. We don't feel that there's anything in particular that is gonna get in our way. There's a lot of operational activity required to deliver on a vaccine like VAX-24 with the level of complexity that we're looking at. We're confident in the guidance that we provided today. We really appreciate all of your support, and I appreciate all the work that the team has put into this, and our colleagues at Lonza as well. Thank you all very much for your attention today, and take care.

Yeah. Thanks, Sara I just like the thank you all for your support of the company. We really appreciate you dialing in and obviously, we're disappointed that we're not going to be able to hit the original A&D guidance. We've made huge strides last year, we don't feel of it there's anything in particular that is going to get.

And our way, there's a lot of operational activity required to deliver on a vaccine like vacs 24 with the the level of complexity of that we're looking at so we're confident in the guidance that we provided today, we really appreciate all of your support and I. Appreciate all the work that the team has put into this and our colleagues at launch as well.

Grant E. Pickering: So we're confident in the guidance that we've provided today. We really appreciate all of your support, and I appreciate all the work that the team has put into this and our colleagues at Lonza as well. So thank you all very much for your attention today, and take care.

So thank you all very much for your attention today and take care.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Operator 3: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Yeah.

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Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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