Good day everyone, and welcome to Pfizer's Analyst and Investor call to review RSV data and COVID vaccine commercial update. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Christopher Stevo, Senior Vice President and Chief Investor Relations Officer. Sir, please go ahead. Thanks, Chelsea, and our gratitude to all of you for joining us today. We're very happy to be presenting some exciting RSV clinical data and provide you with an update on COVID-19. Today, we'll be making forward-looking statements that are subject to substantial risks and uncertainties, and I'd just like to remind you that these forward-looking statements speak only as of the webcast's original date, and we undertake no obligation to update or revise them in the future. You can find additional information on forward-looking statements in our SEC filings, including forms 10-Q and 10-K, under the sections labeled Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. Our agenda is as follows. First, I'm going to introduce our speakers, and then they're going to discuss the RSV RENOIR older adult phase III data. After that, we'll talk about the commercial frameworks for the RSV vaccine and our US COVID-19 vaccine, and then conclude with a Q&A session. Now, let me introduce you to today's speakers. We have Annaliesa Anderson, Senior Vice President and Chief Scientific Officer for Vaccine R&D, William Gruber, Senior Vice President of Clinical Vaccine R&D, and Angela Lukin, Global Primary Care and US President. With that, let me turn it over to Lisa to begin. Thank you, Chris, for the introduction. We're very excited to have the opportunity to discuss our progress in developing a vaccine to help prevent respiratory syncytial virus, which is also known as RSV today. If we can have the next slide, please. We're focused on two patient populations for our RSV vaccine candidate. Maternal vaccines provide an opportunity to potentially prevent disease in infants and babies in their first months of life. The global burden of RSV disease in infants under six months of age is over 6.5 million, leading to approximately 45,000 deaths each year. Our maternal RSV candidate vaccine phase III study is ongoing and expected to read out this year. We'll evaluate the ability of the investigational vaccine to reduce RSV-associated lower respiratory tract infection in infants from birth through six months of age. RSV also has a high burden for older adults and in the US alone, is associated with approximately 14,000 deaths in adults 65 years of age and older. We recently reported positive data from our RSV older adult vaccine candidate for both safety and reduction of RSV-associated lower respiratory tract illness. We're very excited to have the discussion today with you about our phase III trial and associated interim safety and efficacy analysis. Our vaccine candidate contains two stabilized RSV prefusion F proteins. The F protein exists in two forms, prefusion and postfusion. Only the prefusion form on the virus can bind to human airway cells, resulting in the virus entering the cells where it can replicate, causing illness. Seminal studies by the NIH found the prefusion structure of F and identified that the F protein constrained in this prefusion form is more immunogenic compared to the postfusion form. This advance broke a deadlock of over 50 years of RSV vaccine development, providing a potential path forward for a vaccine. We built upon this observation to make a vaccine candidate comprised of two stabilized prefusion F proteins, one from RSV-A and one from RSV-B strains. For the rest of the presentation, we shall refer to this vaccine candidate as RSV Pre-F. In early clinical phase I/II studies conducted in pregnant and non-pregnant adults 18 years and older, the vaccine elicited high neutralizing titers for both RSV-A and RSV-B strains. We also demonstrated that in phase I/II studies in older adults that the addition of adjuvants did not demonstrate a substantial benefit over the un-adjuvanted vaccine. RSVpreF is therefore unadjuvanted. Next slide, please. Our discussion today will focus on reviewing the safety and efficacy data from the pre-specified interim analysis from the phase III study of our bivalent RSV vaccine candidate in older adults. The data from this pivotal study were presented earlier today at IDWeek by Dr. Edward Walsh from the University of Rochester Medical Center, a principal investigator for this phase III study. We also had the opportunity to present these data to the Advisory Committee on Immunization Practices, also known as ACIP, earlier today. Our older adult clinical development program has been comprehensive, including six studies that measured safety, immunogenicity, and for the one that we'll discuss today, efficacy. With that, it gives me great pleasure to turn it over to Dr. William Gruber, our head of clinical vaccine research and development. He'll describe the study and share the detailed results. You can go to the next slide, Will. Thank you, Lisa. It's great to be here today. I'm proud to share detailed safety and efficacy results from the pre-specified interim analysis of the RENOIR study, a phase III study to evaluate the efficacy, immunogenicity, and safety of Respiratory syncytial virus prefusion F subunit vaccine in adults. Next slide, please. As we look at the study design, the RENOIR study is being conducted at 240 sites in seven countries, including the United States. The study is targeted to enroll up to 40,000 participants 60 years of age and older. Participants are randomized 1:1 to receive either RSVpreF or placebo, and randomization is stratified by age. Participants are eligible if they are healthy or have stable chronic conditions, including stable cardiopulmonary disease, diabetes, asthma, or COPD. Immunocompromised persons or those who have serious chronic disorders are excluded. Next slide, please. Let's review the objectives of the phase III study. The primary efficacy objective was to demonstrate the efficacy of RSVpreF in preventing RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms in the first RSV season following vaccination. Secondary efficacy objectives include efficacy against severe RSV-associated LRTI in the first season, efficacy against RSV-associated acute respiratory illness in the first RSV season, as well as RSV LRTI, RSV ARI, and severe RSV LRTI in the second season and across two seasons. We continue to collect severe cases, which will be part of planned final analysis later this year. The primary safety objective was to describe the safety profile of RSVpreF. Next slide, please. I would now like to describe key study definitions, starting with acute respiratory illness, which is defined as having one or more of the following symptoms, sore throat, cough, nasal congestion, nasal discharge, wheezing, sputum production, or shortness of breath with symptoms lasting more than one day. These are the symptoms for which all participants complete weekly eDiaries surveillance entries and trigger a self-nasal swab and possibly a visit. Lower respiratory tract illness is an acute respiratory illness with two or three signs or symptoms of new or worsening cough, wheezing, sputum production, shortness of breath, or Tachypnea. Severe lower respiratory tract illness is defined on key specific objective criteria that represent signs of serious illness as shown. A case definition of RSV-associated ARI or RSV associated lower respiratory tract illness is made when a participant has at least two or three symptoms and a positive validated RSV PCR test. Next slide, please. Looking at the safety profile, this slide shows local reactions at the top and systemic events at the bottom. This vaccine is extremely well-tolerated. At the top, local reactions by maximum severity within seven days of vaccination were more frequently reported in the vaccine group than the placebo group at 12.1% versus 6.6%, respectively. The most frequently reported local reaction was pain at the injection site, followed by redness and swelling. Noted in particular, only about 10% of individuals experienced pain, and this was mostly mild. In fact, most local reactions were mild or moderate and resolved within one to two days. At the bottom, systemic events are shown by maximum severity within seven days after vaccination. Importantly, the proportion of participants who reported a systemic event within seven days were similar in the vaccine and placebo groups at 27.4% and 25.7%, respectively, highlighting the favorable tolerability profile of RSV pre-F. This is a safety profile close to that of placebo, and that is a key consideration for vaccines. Looking more closely, the most frequently reported systemic events were fatigue, headache, and muscle pain and were similar across the groups. Fever was only reported in 1.4% of participants, equivalent in vaccine group and placebo. Most events were mild or moderate and of short duration. Next slide, please. For unsolicited adverse events from vaccination through the one-month follow-up visit, about 9% of participants in each group reported any adverse events. The frequency of related, immediate, severe, and life-threatening adverse events was similar in the vaccine and in the placebo groups. At the bottom part of the table, you can see that newly diagnosed chronic medical conditions were also similar in both groups. There were three serious adverse events deemed by the investigators to be related to the vaccine. Adverse events leading to withdrawal from the study or leading to death were similar in the vaccine and placebo groups. Adverse events leading to deaths were reported in 52 RSV pre-F recipients and 49 placebo recipients. The primary causes of death most frequently reported were in the system organ class of cardiac disorders. None of the deaths were assessed as related to the vaccine. Next slide, please. Now let's review the interim analysis efficacy results. RSV pre-F demonstrated high efficacy against RSV-associated LRTI during the first season. First, let's examine less severe disease. When looking at RSV-associated LRTI defined by at least two symptoms, there were 11 cases in the vaccine group and 33 in the placebo group, with an observed efficacy of 66.7% and a lower confidence bound of 28.8%. Next, RSV pre-F was 85.7% efficacious with lower confidence interval against RSV-associated LRT with at least three symptoms, indicating an even higher efficacy against more severe disease. The case split was two in the vaccine group and 14 in the placebo group. Importantly, both primary end points from the interim analysis met pre-specified agreement for regulatory agencies on licensure criteria. Next slide, please. This slide shows the cumulative case accrual curve from day of vaccination for RSV-associated LRTI with at least two symptoms. The blue line is the vaccine group, and the dotted line represents the placebo group. Vaccine efficacy is shown after day 15, with a mean active surveillance of seven patient months in a surveillance period up to 311 days. Next slide, please. Looking at a similar figure for RSV LRTI with at least three symptoms, vaccine efficacy is shown around day 45. Mean active surveillance was seven patient months, with efficacy persisting up to at least six months. Next slide. In terms of the difference between the two groups, the figures here show the frequency of LRTI signs and symptoms for the RSV LRTI cases with two or more symptoms on the top figure, and it is also displayed at the bottom with three or more symptoms or only two symptoms. Among the RSV LRTI cases with two or more symptoms, cough and sputum production were the most common symptoms reported. In the dark blue bars, for cases involving three or more LRTI symptoms, wheezing, shortness of breath, and tachypnea were more frequently observed than in the two or more symptom group, which is more specific and consistent with increased work of breathing and more severe disease. Next slide, please. Looking at vaccine efficacy for the prevention of RSV LRTI by age group or pre-specified significant conditions showed consistent efficacy across these subgroups. The study was not powered to demonstrate statistical significance for these groups. However, point estimates for vaccine efficacy were well above zero for all subgroups consistent with overall results for prevention of RSV LRTI, with two or more symptoms noted on the top half of the slide or three or more symptoms as noted on the lower half of this slide. Next slide, please. Looking at a similar figure for RSV acute respiratory illness or RSV- ARI, vaccine efficacy is shown around day 45 and persists out to at least 180 days, with positive trends throughout the duration of the surveillance period up to 311 days. The potential benefits of protection against ARI should not be underestimated, as this has the potential to translate into reduced winter season physician visits. Next slide. In conclusion, the interim analysis of the phase III pivotal trial has demonstrated that RSV pre-F was well-tolerated with no safety concerns. Local and systemic events were mostly mild to moderate and short-lived, and the AE profile did not suggest any safety concerns for RSV pre-F vaccination in adults 60 years of age and older. RSV pre-F was highly efficacious in reducing RSV-associated lower respiratory tract illness in adults 60 years of age and older, and also in reducing RSV-associated ARI in this age group. The study is ongoing, and we anticipate having additional data in the future. We are thrilled that in the interim analysis data from the RENOIR study, our RSV pre-F vaccine candidate was efficacious, especially in the more symptomatic and severe patients. The vaccine was well-tolerated with a favorable safety profile, which is important in older adults, some of whom may be more at risk than broader populations. Such a safety profile of the unadjuvanted RSV pre-F vaccine candidate, combined with high efficacy based upon the clinical trial results, has the potential, if approved, to encourage routine vaccine use. Now Angela Lukin will discuss the RSV commercial opportunity as well as US commercial market considerations for Comirnaty. Next slide, please. Thank you, Will. You know, we're very excited about our RSV vaccine candidate for older adults, as it has the potential to strengthen our growing respiratory vaccine portfolio, building on our success and strong heritage with Prevnar and the COVID-19 vaccine, and have a significant impact on public health. In addition to the older adult program that we just heard about in detail, we are looking forward to the upcoming readout of our MATISSE study, which is our global phase III maternal immunization study. Pending data readout and regulatory approval, our RSV vaccine candidate may be the first maternal vaccine available to help prevent RSV in young infants, which would potentially make Pfizer the only company to have both a maternal and older adult indication. Our commitment to RSV doesn't stop there, and we have a unique pipeline portfolio that spans prevention and treatment. Complementing our efforts to advance our RSV vaccine candidate, we have Sisunatovir, an investigational RSV F protein inhibitor asset with potential to help treat RSV-related illness. Like we have seen with COVID-19, Pfizer is deeply committed to helping prevent and treat infectious diseases, and we believe we are uniquely positioned with the best-in-class R&D, manufacturing, and commercial capabilities to deliver successful launches. RSV represents an area of significant unmet need in older adults, and we have the potential to have a real impact on public health with the introduction of our bivalent vaccine candidate, pending regulatory approval. RSV is a common, yet often underreported, cause of acute respiratory illness in older adults, with similar hospitalization and death rates to influenza. It typically manifests with mild to moderate symptoms, though some patients are often more prone to developing severe disease. Older age alone is a key risk factor, but individuals with underlying medical conditions such as heart disease or lung disease are also at increased risk for more severe disease, hospitalization, and other complications, including exacerbation of underlying chronic conditions. As Lisa mentioned, RSV is responsible for 177,000 hospitalizations and 14,000 deaths annually in the United States alone. Just to put this in perspective, the estimated annual cost of hospitalizations for adults with RSV in the U.S. is about $1.2 billion. In the U.S. alone, there's approximately 61 million adults over the age of 65 who will have the opportunity to potentially be protected from RSV with our vaccine candidate, subject to regulatory approval and ACIP recommendations. Once duration of protection data is available, that data will be a key input for defining a potential revaccination schedule. It is highly encouraging to see the progress being made as scientists and researchers have worked to develop RSV candidates with little success over the last half-century until now. We are particularly excited about a number of features of our RSV candidate. First, the Pfizer vaccine is bivalent and includes prefusion F antigens representing both A and B subgroups of RSV. Other vaccines in development only include RSV-A. Second, our vaccine formulation does not include an adjuvant or viral vector component. Adjuvants or viral vector components have been associated with reactogenicity. We look forward to the potential opportunity to deliver our bivalent RSV vaccine candidate to older adults during 2023, subject of course to regulatory approval. This slide gives a snapshot of the rapid progression from phase III study start to potential BLA approval, and we are excited and proud that we could potentially launch our RSV vaccine candidate for older adults within approximately two years of the phase III RENOIR study start. With all of the milestones achieved in 2022, including achieving breakthrough designation in March, it has been a busy year. We've been moving at light speed to advance the program and are really excited for the opportunity to potentially launch our vaccine candidate in time for the 2023/2024 RSV season, pending regulatory approval. Now to RSV maternal. Maternal immunization would provide an opportunity for pregnant women to get a head start during pregnancy to help protect their infants from RSV from day one of life. RSV is a leading cause of global infant respiratory disease. Although RSV can impact all pediatric age groups and most children will have gotten RSV by age two, the burden of the disease is higher in infants younger than one year old and especially those under six months. Pending positive data, we are excited about the potential to deliver our vaccine candidate to expectant mothers to help protect their infants against RSV immediately at the time of birth and during their most vulnerable first months of life. If successful, the RSV maternal vaccine candidate may provide a foundation for a potential maternal immunization platform in the future. Before we move on to COVID-19, RSV is a virus that causes acute respiratory illness in all ages but may be especially serious in infants and older adult populations. As the only company targeting both older adults and maternal indications, pending positive maternal data and subject to regulatory approvals, we believe that we are well-positioned to be a leader in the RSV space. We will now turn our attention to our COVID-19 vaccine to discuss some next steps for our transition to a traditional commercial marketplace. As you know, the U.S. government recently indicated that manufacturers should be prepared for a transition to a commercial COVID-19 market as early as the first quarter of 2023. The EUA environment has been new for all of us, but we will now be moving into our sweet spot of the traditional commercial marketplace. With decades of experience launching and commercializing medicines and vaccines, we are confident that we will see the continued success of the vaccine once this transition occurs. We believe that our best-in-class mRNA capability, coupled with our proven and reliable manufacturing network, will help ensure we are well-positioned to quickly adapt our vaccine, just as we did this past fall. In the first 30 days following regulatory authorization, we were able to quickly scale up and deliver more than 30 million doses of the Omicron BA.4/BA.5-based bivalent vaccine in the U.S. alone. This helped to ensure pharmacies had enough supply to meet demand and represented more than 70% of the doses available in the market during this time period. As we transition to a traditional market, we expect to be commercializing a single-dose vial, which our customers have indicated is their preferred formulation, and our commercial price point for the vaccine will reflect its cost-effectiveness. Over the course of the pandemic, COVID-19 vaccines have saved millions of lives around the world. If you look at the U.S. alone, it has saved hundreds of thousands of lives, tens of billions of dollars in healthcare cost, and enabled Americans to go about their lives more freely. For example, a recently published study conducted by the Department of Health and Human Services showed that vaccination against COVID-19 was linked to 650,000 fewer COVID-19 hospitalizations and 300,000 fewer deaths in the U.S. alone. Additionally, reductions in COVID-19 hospitalizations were associated with savings of more than $16 billion in direct medical cost in the U.S. We are humbled by this impact, and we believe it will be a long-standing example of how we deliver on our mission to deliver breakthroughs that change patients' lives. As we prepare for the transition to a traditional commercial market, our goal is to continue equitable and uninterrupted access to our COVID-19 vaccine for every American and affordability for the healthcare system. Based on our current understanding, when we enter a traditional commercial model, anyone with commercial or government insurance who is eligible to be vaccinated should be able to access the vaccine without any out-of-pocket payments. This is assuming continued broad recommendations supporting annual vaccination. When this transition happens, the commercial price point for the vaccine will reflect its cost-effectiveness. This will include increased cost as we transition to a single-dose vial and commercial distribution. More important, it reflects the value this vaccine has brought to society. We believe a potential U.S. list price between $110 and $130 per single-dose vial for adults reflects the value of the vaccine and is well below the thresholds for what would be considered a highly cost-effective vaccine. As I hope I have made clear today, we have been preparing for this transition for some time, and part of this planning includes a new commercial structure in which the COVID-19 vaccine and treatments have united under the primary care unit. This new organization is unique in that it brings together our full commercial and sales power under one leader, providing increased agility and flexibility across the portfolio. We believe this will unleash the power of our organization to meet the needs of our customers in a more dynamic and nimble way. In addition to our new structure, there are four key areas where we believe we have significant leadership. Number one, contracting. With decades of experience and an extensive portfolio of products, we are working with private entities, including retailers, IDNs, wholesalers, and other buying groups, to secure robust and differentiated contracts, which would go into effect upon commercialization. Number two, field force. Our field force has long-standing and deep relationships with key stakeholders in the vaccine ecosystem and is already actively educating vaccinators on our vaccine profile and driving the urgency for eligible people to stay up to date with their latest booster. With our new structure in place, we have the flexibility to be able to deploy them to the right healthcare providers at the right time. Third, manufacturing and distribution. You know, since the earliest days of the pandemic, our manufacturing capabilities have been unmatched. As we head into this next phase, we plan to evolve the packaging and storage of the vaccine to better meet customer needs and the commercial workflow. These include single-dose vials, last-mile shipping options, and more flexible minimum ordering quantities. Additionally, we aim to build on our long-standing partnerships with wholesalers to provide ordering and stocking options that more closely resemble the normal course of operations in a commercial environment. Last but not least, consumer engagement. Today, we are using our expertise in actively educating and engaging consumers with robust communication and a leading share of voice in digital, social, TV, radio, and influencer channels to drive awareness and trust in our vaccine. We continue to find new ways to reach patients, including signature collaborations and sponsorships. We will maintain that effort to help ensure patients understand booster eligibility and the need to stay up to date on vaccination. While a commercial marketplace presents new complexities, we are confident that we have the capability to make this a successful and seamless transition for our customers. Healthcare providers, and most importantly for patients. I'll now turn it back over to Chris to facilitate the Q&A session. Thanks so much, Angela. We're gonna start our Q&A session. We have just under 30 minutes. We have a hard stop at 5:30 P.M., so we ask you that you could be as crisp and brief in your questions as possible. Chelsea, please go ahead and start the Q&A session. Yes, sir. At this time, if you would like to ask a question, please press the Star and One keys on your touch tone phone. Once again, that is Star One to ask a question. Our first question will come from the line of Mohit Bansal with Wells Fargo. Hi. This is Serena Ahn from Mohit Bansal. Thanks for taking my question. Wanted to ask about the endpoints between Pfizer's trial and GSK's, and kind of giving the different definitions for RSV ARI, RSV LRTI, or which endpoints would you compare to which? Thank you. Thank you. Thank you very much, Serena. Lisa and Will, would you like to take that? Yeah, thanks for the question. I think the important piece is not to compare, you know, endpoints from different studies, but really rather focus on the endpoints and the resulting results. We designed our trials based on feedback from infectious disease experts and, you know, also working with the FDA to ensure that we really made sure that we didn't have subjective measures of RSV disease. We're, you know, very much concerned to be able to capture the lower respiratory disease, which is where, you know, the biggest burden lies on healthcare and on the population. We wanted to make sure that we had, you know, a vaccine that was safe, well-tolerated, and highly effective at preventing lower respiratory tract illness. As you can see from the data that Will presented, we saw over 85% efficacy there. Will, would you like to add a little bit more? Yeah, I think, I mean, Lisa has characterized it well, and I think we also heard it well characterized by Mikael Dolsten at the ACIP meeting today, where he made the point that you really can't compare across studies. You're better off just talk, you know, in an absolute sense about what you're seeing. Are you seeing what you would hope to see in terms of the potential to protect against serious illness and keep people out of the hospital? I think the balance of evidence that we have shows just that as you start with acute respiratory illness as kind of the lowest or the most minimal sort of illness and work your way through to more specific measures of lower respiratory tract illness, you see progressively higher levels of efficacy. Even though we've not seen hospitalized patients to a significant degree to get to an endpoint, nonetheless, this data basically supports what we've seen in every other circumstance with mucosal pathogens with a successful vaccine that proves the efficacy proves to be higher for the more severe disease. I would put it in that context. As Lisa said, the other key piece is the vaccine doesn't do any good if nobody takes it. It's important to have a very good safety profile, and as you've heard me describe, this safety profile is very comparable to other commonly used vaccines that have a high degree of acceptability. Thanks, Will. Chelsea, next question, please. The next question comes from the line of Louise Chen with Cantor. Hi. Thanks for taking my questions here. Just quickly on the payer discussions on your single-dose COVID vaccine for the commercial market, that $110-$130, have you had those discussions, and how willing are they to pay for that? How do you think about penetration in a commercial market? Second question is just, you know, there's a couple of different adult vaccines in the RSV market right now that are in development. What do you think the ACIP and physicians will base their decision on or recommendation on when they look at these different products? Thank you. Thanks, Louise. That sounds like a question for Angela to start, and if Will and Lisa want to add anything, please go ahead as well. Yeah. I would just say we're in the very early days, really, in terms of discussions with payers from that point of view. I think that, you know, the goal really is to ensure that we're having robust discussions. I think, you know, look, based on the market analysis and the cost-effectiveness modeling that we have run, you know, we know that that price range really does represent highly cost-effective modeling. As I mentioned before, the number of deaths and almost $16 billion worth of cost in the U.S. alone in terms of COVID was pretty substantial. I think we feel confident that this range will be seen as highly cost-effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine. In terms of your second question with regard to, you know, a lot of competitors coming now into the RSV space, I mean, look, I think the way in which we've looked at it is, you know, given our experience in vaccines, we still have quite a few milestones yet to come. Obviously, we need to make sure that we file our BLAs by the end of the year for both adult and maternal, assuming positive maternal data. There's still quite a few milestones to overcome, obviously with FDA, ACIP recommendations. But I think one of the things that we know about this category is how much the profile of the product. For HCPs and vaccine purchasers, they really do look at and rely on the safety, efficacy, and tolerability as well as contracting and supply reliability when thinking about a vaccine that they're gonna use for patients. Regardless of how many competitors are out there, we do believe that Pfizer is uniquely positioned given its vaccine experience and given the profile of the product to really drive and have leadership in this space. Thanks. Next question please, Chelsea. Our next question will come from the line of Terence Flynn with Morgan Stanley. Hi. Thanks for taking the questions. Two for me, one on COVID. I just wonder how you're thinking about predicting demand for the boosters in 2023, given where we are in the COVID cycle and given the move to the commercial market. Maybe how are you gonna go about predicting demand and providing guidance to the street around that? And then the second is on the RSV market opportunity. I think I was looking back when you originally talked about the peak opportunity for your vaccine. It looks like the focus was more around the maternal setting. Obviously, now you have adult data in hand, so how are you thinking about the peak opportunity now that you've seen the adult data? Thank you. Yeah. Thank you. Look, you know, just in terms of your first question about how we're thinking about the market, you know, it's very early days, and there's many variables to consider, as it relates to predicting current. By the current, I mean even just the fall of this year, let alone the future uptick in 2023. For this fall, variables include timing of people's eligibility to boost, due to recent infection and/or when people received their last boost, as well as the personal decision-making on when to boost. For example, helping to ensure, for example, protection around the holidays that are coming up. However, we think about, you know, the future uptake in the coming weeks and months that are certainly similar to the trends between COVID and flu. In particular, the rate of booster uptake in the first six weeks post-launch compared to the flu in the same time period are actually very similar. As we look forward beyond this fall into 2023, there's also a number of factors of uncertainty which make it difficult to predict uptake, including the precise timing of commercialization. However, we expect that the annual COVID booster uptake may reflect historical flu uptake rates for adults and older adults. With that said, given the pediatric COVID-19 vaccine booster adoption rates that we've seen to date, the annual booster uptake rate for the ped group will likely take longer to build to flu-like pediatric uptake rates, potentially later than 2023. Encouragingly, we are seeing a positive trend in adult co-administration of flu and COVID vaccinations year-over-year. Just to kinda give you a sense, last year, same day co-administrations were in the teens, while this fall co-administrations have increased to roughly 40%. Additionally, we potentially are looking at a launch of a flu and COVID combination product, and we expect that this will also help to improve updates due to convenience for HCPs and consumers alike. Still early days and a lot of key variables that kinda have yet to be determined. Then your question about transitioning to the commercial model. You know, currently the COVID-19-related contracts between Pfizer and the U.S. government continue through the end of this year, so the transition to a more traditional commercial model wouldn't happen until the first quarter of 2023 at the earliest. This transition will be triggered by the expiration of current contracts, depletion of government supply, and potential rollout of adapted vaccines to match any shifting strains. Your last question, which was really about the opportunity that we see in RSV. I mean, look, we are very excited about the RSV candidate in older adults, as it has the potential to strengthen our growing respiratory vaccine portfolio and address an important unmet need, of course, subject to regulatory approval. RSV represents an area of significant unmet need in older adults. For example, U.S. alone, RSV infections accounted for, I mentioned before, 177,000 hospitalizations and 14,000 deaths each year. We have the potential to have a real impact on public health with the introduction of the bivalent vaccine, of course, pending regulatory approval. On the maternal side, you know, RSV can be dangerous for some infants and young children. Each year in the United States, an estimated 58,000 children younger than five years old are hospitalized due to RSV infection. Virtually all children get RSV infection by the time they're two, and it's the leading cause of hospitalization in children less than one year of age. If successful, maternal immunization could provide protection from the first day of life. We've been moving with light speed to advance the programs and really excited about being able to launch our RSV older adult vaccine in time for the 2023/2024 RSV season. Maybe I'll just say lastly, as the only company to potentially have both the older adult and maternal indications, of course, pending positive maternal data and subject to regulatory approval, our commitment to RSV doesn't stop there, and we have a unique pipeline that also includes the potential for treatment. For those reasons, we believe that we're well-positioned to be a leader in the RSV space. Thank you, Angela. Thank you, Terence, for the question. Chelsea, next question please. Our next question will come from Robyn Karnauskas with Truist Securities. Hi, this is Nishant on the line for Robin. A couple of questions. One for maternal study. Regarding endpoint for that study, what can we expect in terms of the endpoint? Will that be similar to the older adult study? In terms of COVID vaccine, any bookends on when the COVID vaccine will go commercial? What are your thoughts about pricing ex U.S.? Will that still be government contracts or individual doses like in U.S.? Thank you. Thanks, Nishant. I think the first question would be for Lisa and Will, and then for the second question, that would be more of an Angela question. Maybe I can take the first one about the nature of the endpoints for the maternal immunization trial. I think everybody appreciates that women are being vaccinated when they're pregnant, and a mother's gift of antibody is passing to the infant, and then we monitor these children from the time of birth through the RSV season. The key endpoints are medically attended lower respiratory tract infection and severe medically attended lower respiratory tract infection. Again, as you heard, you know, we anticipate having a readout on that before the end of the year and hope to file before the end of the year. Thanks, Will. Angela? Yeah. In terms of the timing of the shift to the commercial model really will be contingent on, you know, the COVID-related contracts that we have with the U.S. government as they're gonna continue to the end of the year. The transition to that more kind of commercial model wouldn't most likely happen until the first quarter of 2023 at the earliest, and this transition will be triggered by expiration of the contract, depletion of government supply, and/or potential rollout of any adapted vaccines to match any kind of shifting strains that may appear. Your question about pricing outside the U.S., you know, the timelines and the mechanism for a global pricing vary, and we'll be, of course, working with local markets to determine pricing as we look to transition from the pandemic distribution model to normal procurement paradigms in those markets. However, in 2023, we have government contracts in many developed markets outside the U.S., and as such, have already agreed upon pricing in those markets. Thank you, Angela. Chelsea, next question, please. Our next question will come from Chris Schott with J.P. Morgan. Hi. Great. Thanks so much. Just wanted to follow up on the COVID vaccine. I'm trying to understand the pricing dynamics a little bit better here. I guess, first of all, do you expect that there's going to be significant discounting in this market from this list price you're rolling out? And will, I guess, the severity of this season's COVID wave play any role in, I guess, where net price settles out as you think kind of the value of the vaccine's kind of offering? And then just a really quick one on RSV. I think you're still waiting for some of this data, but what is your base case in terms of how frequently someone would have to be revaccinated in this older adult market? Thanks very much. Thanks, Chris. With regards to the discounting and the value in discounting, that would be a good question for Angela. With regards to the duration of protection, that would be Will or Lisa. Maybe I'll just start. You know, I think that we believe that this is gonna follow traditional modeling that we have, for example, with vaccination. The system in which the COVID-19 vaccines are purchased and distributed really will be different than under the emergency process set up during the acute phase of the pandemic, and the market for vaccines will be a bit smaller, having, you know, different purchaser requirements and more fragmented than it was in 2021 and 2022, which will lead to some higher cost, which include manufacturing of single dose, transportation costs, and evolving the commercial distribution model. I think as we think about the traditional rebating, it will follow what we typically do in vaccines, and it will factor into, as I mentioned before, the cost value for the asset. I think as we head down this road, the good news is we have a lot of experience in this space with our vaccine portfolio, and we'll be able to leverage you know, contracts, relationships, and our portfolio as we look to partner with key institutions to ensure equitable and broad access of the vaccine. Thank you. Will or Lisa? Duration of protection. Maybe I can deal with the persistence in revaccination issue. We were very encouraged, I think, by the phase I/II data that suggested persistence of antibody well above baseline out to a year. That bodes well for potential protection, and hence we built into the study the ability to look at a second season protection. Once that data is available, we'll then be able to define what that level of protection is and whether it's necessary to give a second dose a year apart or two or three years apart. Thanks, Will. Chelsea, next question, please. Our next question will come from the line of Chris Shibutani with Goldman Sachs. Yes. Thanks very much. On the COVID vaccine front, the question would be about the potential for thinking about variants and how that would have influenced your thinking on final negotiated price. Then perhaps something for the RSV vaccine. How are you thinking about. It sounds sequentially the adult population will come first, and the pediatric opportunity, the maternal would be later. How do those, that timing and the sequencing of that factor into your thinking about pricing for the RSV vaccine? Thank you. Thanks, Chris. How do emergence of new variants of concern influence our thoughts on the final negotiate commercial price for COVID vaccines? RSV vaccines, how the timing of the adult indication versus the peds indication later, how that impacts pricing. Those both sound like questions for Angela. Angela, do you wanna take those? Yeah, sure. You know, as we think about the cost effectiveness and cost savings, you know, those have been factored in. I mentioned before about just some of the increasing costs that have gone in, but obviously one of the factors is, you know, the commercial list price reflects the value delivered not just by the vaccine, but also allows Pfizer to maintain our commitment to health equity and reinvestment in manufacturing capacity and preparedness in the U.S. and across the globe to ensure that we're also staying one step ahead of the vaccine. We know that these variants and COVID mutates, and so we want to make sure that we are prepared to be able to address that. For the purposes of how we're thinking about pricing, it takes into account various different costs, increased cost-effectiveness, and ensuring that we are prepared and ready to be able to address, you know, potentially the next possible variant. Great. Thank you, Angela. Operator, next caller please. Next we have Tim Anderson with Wolfe Research. Thank you. When will we know the answer on RSV about whether it's annual or not? That's the first question. Second question is on pricing. You know, it's one thing if you're the only supplier out there, but you're not, so I'm wondering what your assumptions are on potential price competition. Last question, any thoughts about telling us what the profit contribution is from COVID vaccine like you used to do? Okay. Thanks very much, Tim. I appreciate those questions. Will, maybe you wanna take the timing on the duration of protection for RSV, when we'll know? Yeah. Angela, maybe you wanna take the pricing versus the competition. Then, Angela, I don't know if you wanna take the COVID vaccine profit contribution, or if not, I'm happy to discuss that. Thanks, Chris. I think, for the RSV vaccine, as we just described, we're now monitoring these individuals that have gone through a first season into a second season, which, as you know, is starting right now. You can anticipate that as we get in sort of the late spring, but likely in advance of the ACIP meeting that's gonna occur in June, we would have efficacy for that second season that would then help dictate the necessity for annual or potentially a longer interval vaccination. I think that's the piece, though. It's an ongoing study. Yeah. Once we have the data, we'll obviously share it externally. Thanks, Will and Lisa. Angela. Sure. You know, just in terms of pricing, you know, the price for the COVID vaccine reflects the value that we believe it delivers to patients and society based on our cost modeling, and we believe that the CDC will recommend annual COVID-19 vaccinations for a broad population, meaning that there'll be no out-of-pocket costs for Americans regardless of which insurance they have. Though we cannot compare list prices across different vaccines without considering discounts, broader contracts that may be in place with specific payers, and the level of reinvestment in pathogen surveillance and future vaccines, Pfizer is the only manufacturer to successfully have researched and developed a COVID-19 vaccine without receiving federal government funding, and the company is still reinvesting heavily in expanded manufacturing capacity in the U.S. and across the globe and adding its supply chain to ensure a steady supply of vaccines and therapeutics. Then just in terms of the question related to level of profit, you know, obviously Pfizer's committed to finding and developing vaccines to protect against COVID-19 and, as I mentioned before, the only one to successfully develop a vaccine self-funded. That commitment and level of investment continues as we transition to an acute phase of the pandemic, with construction of additional manufacturing facilities, surveillance, pathogens, and of course working tirelessly to develop the next generation of mRNA vaccines. We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost-effectiveness and ensures that price will not be a barrier for access for patients. And, um, if you- Chris, if there was anything more you wanted to add about profit? Yeah, please. Tim, as you know, but just to make sure everyone is reminded, the biggest determinant of the gross margin on COVID vaccines for us is the 50/50 gross profit split we have with our partners at BioNTech, so that's the key driver there. We also talked about how the cost per unit are very different for multiple dose vials versus single dose vials. The logistics are very different. So it's gonna be a different construct. But again, the biggest determinant is that profit split. I'm sorry. We forgot to answer the last question from Chris Shibutani. That's my bad. Angela, maybe if I can just ask you, given the timing of when we're getting the adult data and potentially the authorization and the timing of when we begin the maternal data and potentially authorization, how does that different timing potentially impact the pricing of our RSV vaccine? For the purposes of pricing, I mean, obviously our goal is to file both with the FDA before the end of the year, and we plan to target value-based pricing to support broad routine age-based recommendations by ACIP for older adults pending successful data readouts and regulatory approval for the pregnant women to help protect infants with RSV. In the older adult segment, we know that recently adopted U.S. legislation of the Inflation Reduction Act will enable $0 copay for Medicare patients. As we think about pricing and we think about the broad, right now our focus obviously is on older adults, but we're looking at price to value as we think about the portfolio and the indications. Yeah. I think the heart of Chris Shibutani's question was as Will answered, by the time we'd be making those decisions, we would have a good sense of duration of protection offered, and we would also have a good sense of what the efficacy looks like of the maternal vaccines. Thank you. Next question please, Chelsea. The question will come from Geoff Meacham with Bank of America. Hey, everyone. Thanks for taking the question and for doing this call. I just have a couple. One on COVID. You know, would the commercial model for the vaccine differ versus Paxlovid? I'm just trying to think about, you know, pricing versus access differences. Then on RSV, you know, what's the gating factor for the filing for this year? You know, are there subgroups that you guys would want to maximize differentiation on and maybe just wait for? Then the last question is would you expect a recommendation in older adults, say, you know, greater than 70 years and up? I'm trying to reconcile, you know, what ACIP may ultimately recommend versus what supportive data you have as of now. Thank you. Okay. Thank you very much, Geoff. We're gonna shake things up a little bit. Maybe Will or Lisa, you can start out with your thoughts on whether ACIP will give a recommendation versus a subgroup, older subgroup versus the entire population. Maybe, Angela, you can take the two questions on RSV in terms of gating factors for pricing and differentiation. For COVID, how will the commercial model for the vaccine differ potentially from Paxlovid when that goes commercial? As far as the question around, you know, will ACIP look at specific groups, you know, we saw today from their working group meeting what they felt was important for what a vaccine needed to deliver from a public health benefit. You know, many of those things apply to older adults. Whereas we can't, you know, predict, you know, what they're going to do, you know, one can look at other vaccines and generally one looks at vaccines for older adults as a single category, and it doesn't tend to be parsed out. Obviously, risk factors come with age, and you can't always predict when they're gonna come, and you want to make sure that you have an umbrella of protection for that vulnerable group at you know pretty set times so that then it's much more uniform and much more easy to you know maintain compliance and help physicians know you know when people should receive their vaccines. Thanks, Lisa. That was great. Angela, with regards to the COVID, how that commercial model differ versus Paxlovid, and then for RSV, your thoughts on the gating factors for pricing and differentiation. Yeah, I mean, just in terms of, you know, the commercial model and the differences, obviously from a vaccine point of view, we'll be partnering with purchasers and retailers as primary contracting opportunities. As we think about the support that's gonna be required, obviously there it's gonna be a big focus on, of course, those people that are doing the vaccinations and the key influencers of that. Whereas if we think about Paxlovid, it's gonna be broader with a broader group of payers and really the need to support also with a broad field organization, raising awareness around the high-risk factors, making sure that there's testing and treating going on, and making sure that HCPs, because any HCP in the United States can prescribe Paxlovid, that there is a good understanding of the benefit/risk profile and that they understand how best to use it. The model and the support that will be required for those two products will vary and be different based on the prescribers and/or vaccinators that touch those two different businesses. In terms of stage-gating the pricing and how we're thinking about it, obviously, you know, need to understand once the data readout comes out from maternal to understand the profile of that as we look at it versus older adult. Then a key factor as we set and think about the pricing will be also related to vaccination schedule. There still are quite a few milestones and of course, recommendations that would potentially come post assuming FDA approval from ACIP. Those are all gonna be key factors that will input into the final pricing within RSV. Thank you, Angela. Chelsea, I think we have time for one more brief question. Sir, our last question will come from Steve Scala with TD Cowen. Thank you so much. Pfizer is likely seeing some incidents of premature labor in its maternal RSV study. There wouldn't seem to be any reason why the Pfizer experience would be different than that of GSK. There are factors which create noise, such as COVID and different incidents in different populations. Why is Pfizer comfortable with all of these factors? Secondly, in terms of events avoided, the degree of benefit seen in the adult RSV trial reminds me of the Prevnar adult data from CAPiTA, and that turned into a decade-long struggle to establish it in that population. Why is that not a good comparison for modeling RSV? Thank you. Okay. Thanks very much, Steve. I think the first question regarding the maternal study, that would be a good one for Lisa and Will to answer. In terms of the ACIP recommendation and how that would be similar to PCV thirteen in adults CAPiTA, I think Lisa and Will could also take a crack at that, or maybe Angela, if she has any thoughts. Steve, sorry, could you clarify your first question around the maternal vaccines? Because I think you got the wrong company when you were going through the question. Well, yeah. Yeah, go ahead. GSK stopped their program because of premature labor. I'm just wondering why Pfizer can continue and feel comfortable with it, given all the factors that wouldn't seem to be a reason for a different incidence in the two studies. Yeah. Obviously we can't comment on the nature because we don't have a window into what caused GSK to actually stop their study. There's a recognition, of course, by our independent DMC that GSK has stopped its study. We have looked at presumptive sorts of findings that might have been associated with the study stop, and we have seen no signals related to stillbirth, prematurity or anything else. The DMC has indicated that we should enroll the full 7,400 women and follow their babies. You know, I can't speak to what's happening with them, but I can say that we're confident about the safety profile of our vaccine in pregnant women. The analogy between older adults for the ACIP recommendation and then CAPiTA for Prevnar 13. You know, when one looks at CAPiTA, essentially before we had the readout for CAPiTA, we had the 13-valent vaccine licensed. It wasn't recommended by ACIP for the adult population until we had the readout for CAPiTA. After we had the readout for CAPiTA, we actually did see a very large uptake of vaccine in the older adult population. I think, you know, the key was to show the efficacy, and once we showed the efficacy, we did see, you know, a large proportion of older adults taking that vaccine. Will, of course, you were responsible for that study. Yeah. Well, no, I think the CAPiTA What did you- Again, we've leapfrogged here, right? You know, in that circumstance, we got accelerated approval based on demonstration of non-inferiority and an advantage to the conjugate vaccine in terms of stimulating memory and a robust immune response that was likely associated with protection. As Lisa said, it wasn't until we had the efficacy that, you know, the uptake was, you know, quite high and with that large base of individuals that were over 65 who could be vaccinated. In this case, we're doing efficacy right from the start. That should provide confidence for both the maternal immunization program as well as for the adult program. That should provide the necessary confidence to help the ACIP come to a favorable recommendation. Thanks so much, Will and Lisa. I appreciate that. Steve, thank you for the question, and thank you everyone for taking the time to join us this evening. We appreciate it. Please let us know if you have any follow-ups. Thank you. Bye-bye. Thank you, ladies and gentlemen. This does conclude today's call. We appreciate your participation. You may disconnect.