Good morning, everybody, and thank you for participating in the final day of our SVB Global Healthcare Conference. My name is David Risinger. I cover diversified biopharmaceuticals, and it's very much my pleasure to welcome leaders from the Pfizer leadership team. With us this morning, we have Andy Schmeltz. He's Senior Vice President, Commercial Strategy & Innovation, and Navin Katyal, who is U.S. Commercial and Global Business Lead for the mRNA portfolio. We're fortunate to have them both here with us today and just wanted to extend my thanks to you both for taking the time to join us. I thought we'd start off with a high-level question for you, Andy. I know that you obviously kicked off a very helpful discussion on Pfizer's innovation initiatives at your analyst meeting in early December. It'd be helpful for you to just, you know, sort of summarize that, highlight your vision for strategy and innovation, you know, how you see your mandate and your role and the timeline, you know, to execute on the M&A agenda that you've outlined for the investment community. Thanks, David, and very pleased to be here with you and have the opportunity to engage in this dialogue. My organization, Commercial Strategy & Innovation, is accountable for the mid to long-term strategy for the company, including the investments that we make in our pipeline, as well as external substrate business development opportunities, really to maximize the impact we can have for patients, for society, and of course, for our shareholders. Really, Pfizer's at an inflection point today. We have an industry-leading R&D productivity that we've worked really hard to improve over the past five to seven years. We have a robust pipeline of innovative assets. We have one of the highest, if not the highest R&D budgets in the industry. As we articulated in our Investor Day in December, we have up to 19 launches expected over the next 18 months, the most ever for the company. Our goal that we've stated now consistently is to add $25 billion in risk-adjusted revenue by 2030 from external innovation. From business development, sourcing externally. We've made meaningful progress towards that goal. We believe we're more than $10 billion of the way there for revenue in 2030, about 40% of our goal. Our plan going forward is to complete that goal. We're looking for opportunities across our core therapeutic areas and across phases of development, and we're agnostic to size. Over the past few years, we've achieved bolt-on acquisitions like Global Blood Therapeutics, Biohaven, ReViral, Arena, and Trillium. We've engaged in development collaborations with partners like Arvinas, Myovant, and Valneva, and in also strategic collaborations, including our efforts to unlock the full potential of mRNA with BioNTech and Beam. The bottom line, we're looking to create value and to add value, and we're looking for breakthrough opportunities that can have an impact for patients and add and create substantial value as well. That's, that's really the approach. We're confident that we can get there, and, you know, happy to go in any more detail that would be helpful. That's a great way to kick off. Thank you. With respect to that $25 billion target by 2030, could you just put into context the actual 2030 revenues relative to the hypothetical peak sales that you're targeting? Because obviously for some of the BD products will be growing beyond 2030. Absolutely. We're very mindful, especially as the clock is ticking, that, you know, there's some opportunities to truly generate near term value over the next couple years and peak around 2030. There are other opportunities, probably a lot more substrate out there now that it's 2023, where the launches could come between 2025 and 2030 and the peak will be realized afterwards. I think just to recap, you know, why did we pick 2030? It's because we know that between now and then that there's a lot of change in our portfolio that we're gonna experience loss of exclusivity in a number of key medicines. I think we've stated that's about $17 billion between 2025 and 2030 in some key medicines, IBRANCE, ELIQUIS, XTANDI, et cetera. We have this BD opportunity that we've stated to kind of source about $25 billion in peak revenue. That will more than mitigate those LOEs. These 19 launches over the next 18 months, we believe in totality will generate $20 billion in revenue by 2030. That includes exciting catalysts in 2023 with elranatamab, with talazoparib for prostate cancer, with our etrasimod from Arena, the launch. There's three other inflammation immunology medicines that are coming. Of course, continued enhancements with mRNA, and Navin will speak to with our flu program also that's on track for 2024. That's the kind of the second component. What we tried to go in detail at our investor day in December was additional pipeline that we're very, very excited about that's coming before 2030, and that includes our GLP-1, oral GLP-1. That includes our interferon beta. That includes TTI-622 from our Trillium acquisition, as well as more. Hopefully that kind of characterized it. We're certainly not providing guidance for 2030, but we're trying to articulate that there's a lot that we have going for ourselves that puts Pfizer in a strong position, and we believe it's very achievable over that 2025-2030 timeframe. Excellent. Okay, great. With respect to pursuing additional M&A, obviously Pfizer is doing some internal pruning. Two questions on that. First, could you explain the rare disease reorg and agenda going forward? Second, should we expect additional pruning since you'll be pursuing additional M&A? Happy to address that. With our improvements in R&D productivity over the past several years, we have a lot more demand for our R&D resource than ever before. Well above the levels that we are identified in our guidance. It's forcing us to be very, very purposeful in the prioritization of our pipeline. There are many medicines that are promising science and can have an impact on patients. We're looking for ways to make sure we're investing our scarce R&D dollars in the best possible ways for our shareholders and for society, but we're enabling those other medicines to also be advanced. That's where partnerships or externalization comes into play. Specifically for rare disease, we're kind of rethinking our approach to early discovery and development. Rather than having a dedicated research unit in rare disease, we are taking the programs that align with our other therapeutic areas and aligning them with those research units. Benign hematology, we have a significant hematology presence in our oncology arena. Obviously, with our Global Blood Therapeutics acquisition, we will continue to be focused in benign hematology. For areas that don't fit, we feel that they could be promising, but it's probably others are better positioned going forward to advance those. That's why we're have initiated this process to seek externalization of that, those components of our early rare disease portfolio. Could you just restate that? You're seeking to externalize explicitly which components? Well, the components that don't fit with our other therapeutic areas where we have the capabilities, where we think we're in a better position than others to advance them. For programs that don't fit, that don't connect in benign hematology or, you know, whether it's aligned with inflammation immunology, you could say that our Interferon beta kind of presence, rare areas like that. Rare cardiology could be relevant. We have cardiology capabilities in our internal medicine research unit. Where there's areas, gene editing also is an area that continues to be very interesting to us. We had a bunch of other programs, rare neurology, et cetera, that might not, that might be better suited somewhere else, and those are the ones that we're looking to find partners for. Got it. Okay. That's very helpful. Great. Well, why don't we pivot to Navin? First of all, we appreciate you being here with us. It's a nice opportunity to dialogue with you. Could you start with a framework for your vision for Pfizer mRNA? Also as you discuss that vision, just remind us which technologies and programs are wholly owned versus partnered with other companies. Sure. First of all, David, thanks again for having us. Great to be here. I think, you know, just first let me just start by saying, you know, we are very proud of, you know, all the progress that we've made in this, you know, still nascent space. That gives us a lot of confidence as we move forward with our, you know, capabilities and our programs. You know, I think we've sort of demonstrated, I think, great leadership just right out of the gate, right? The world's leading COVID-19 vaccine, the first out of the gate with the primary series and boosting for, you know, a variety of groups and also the first to deliver a bivalent vaccine in record time. Again, you know, tremendous confidence as we, as we progress forward. Our strategy is sort of fourfold as we, you know, continue to advance the sort of the capability and our platform. The first is, of course, we wanna continue to invest to ensure that we continue to keep our leadership with our COVID-19 vaccine program. Continue to advance our booster strategies, really, you know, continue to address emerging variants because the virus continues to mutate and then, you know, continue our programs around our next gen for our COVID-19 vaccines. Of course, we wanna continue to advance and expand the vaccines portfolio, so other infectious diseases, flu, shingles, respiratory combo, et cetera. Of course, finally, you know, the R&D into new therapeutic areas. Our mRNA and gene editing in rare disease, for example, is another area that we think holds a lot of, you know, opportunity for success on top of just the, you know, overall investments that we continue to make in terms of our design delivery and manufacturing platform for mRNA, where we've continued to be a leader. I'd say those are sort of the four Pillars, right, as we move forward. Regarding your question about where we're sort of, you know, advancing on our own, you know, for now, our COVID-19 program remains and, you know, will continue to be partnered with BioNTech. They've been a fantastic partner, and we'll continue to work with them moving forward. That's why we're also planning to partner with BioNTech moving forward on other programs, including shingles and then also in the respiratory combo space, particularly in the flu and COVID-19 space. Then, you know, we have our influenza program, which we're very, very excited by. That is a, you know, a different setup. You know, our agreement looks different for flu, where we will royalty bear, but we are, you know, moving forward on our influenza standalone ourselves. That's sort of the framework. Again, you know, we're very, very excited and, you know, continue to, I think, be bullish given the leadership that we've had thus far. Great. Could you just add a little bit more color on the flu program's different setup and how that will integrate with a, you know, a combo, COVID-19 flu offering down the line? Yeah, absolutely. You know, maybe I'll just start with flu, you know, particularly, and then I can get into the combination. You know, I think, look, the flu space is a very, very large market, but we know it's commoditized, and it's dominated by, you know, traditional technologies that have been around forever, right? 70 years, I think, is when the first technologies were developed. You know, we have egg-based vaccines that sort of dominate the market. Efficacy is very, you know, it's variable, right? Year- over- year, anywhere from 20% to max 60%, year- over- year for a variety of reasons. We've had some new technologies, but I think there's still a tremendous opportunity for improvement. I think if we think about our mRNA technology, right? Number one, we believe, you know, elicited T-cell response on top of antibody response could potentially, you know, confer a efficacy benefit vis-à-vis what's on the market today. I think, you know, no surprise, right? Our mRNA technology, it is the fastest vaccine technology by far, so that rapid manufacturing and that agility could really help in terms of agility on strain match. Then, you know, we've seen the space marked with supply disruptions, you know, in various years. The ability for, you know, a company like Pfizer with the scope and scale that we have from a manufacturing perspective, just like we've demonstrated over the last couple of years, I think all of those things combined can, you know, confer a tremendous opportunity to disrupt the market and frankly, you know, become a leader, you know, relatively quickly. As far as the combo is concerned, you know, I'm super excited by that. There is tremendous desire, when we talk to providers, we talk to HCPs, and we also do consumer research for convenience, right? We know that the vaccine market will get even more crowded from, particularly in the adult space. Having a combination could be incredibly powerful. As we outlined, I think, in our, some of our, you know, prior discussions, you know, there's an opportunity, I think, to also continue to drive COVID uptake as we launch the combo in the years to come. You know, all told, we're very excited about the portfolio. Excellent. With respect to flu, could you compare and contrast the agreement with BioNTech, versus with, on Comirnaty, please? Sure. I think, you know, with the, with the Comirnaty standalone agreement that we have, you know, we have a gross profit split with Comirnaty. On flu, we have the exclusive right to carry out the development and the commercialization of the flu candidate. Upon, you know, approval, BioNTech would essentially receive a royalty on our sales. That's basically the delta between the two. If you do develop a combo, what happens then? Yeah. I think, you should not expect that we would have a arrangement that, you know, looks like the standalone Comirnaty, that gross profit split. You know, we're still partnering with BioNTech to finalize those terms, and those are confidential at this time. Okay. Got it. Very helpful. Excellent. And then I was hoping that you could talk about, I guess, a few things that you mentioned in a little bit more detail. Let's just touch on shingles, for example. What is the profile that you're looking for? What is the target product profile to take market share? And then why is it partnered with BioNTech? And what are the economics on that, please? Sure. I think in terms of the why BioNTech, they've been a tremendous partner to us. You know, first and foremost, you know, we just like working with them, right? I think it's as simple as that. In terms of the profile and how we see ourselves entering the market, certainly Shingrix is a, you know, a great vaccine, no doubt about it. I think a couple of things. One is the market is very large. There's still a lot of unmet need. You do see that there's an opportunity to improve on the tolerability profile. You know, the sort of optimism we have with our platform is that we will be able to potentially make inroads in addressing tolerability. When you combine that with, I'll just say, the commercial capabilities that we have here at Pfizer, the promise that we have in terms of contracting, you know, engaging with HCPs, educating consumers, I think, you know, that plus, a profile that we're, you know, aiming for could make a big opportunity for us as we, as we move forward. That's how we're thinking about shingles. Great. Have you disclosed the economics there between the two companies? I do not recall if we've disclosed that, so I can follow up offline. Okay. Just one more. What is your expectation for the durability of protection against shingles? How will you demonstrate that? Yeah. I, you know, I won't profess to be the expert on the clinical, you know, nuances here, but I would just say that we aim to have, you know, very similar, you know, if not better, but we at least from an efficacy perspective, you know, similar. Of course, as I was saying earlier, on the tolerability, we aim to make a improvement because I think there's a big opportunity and unlock in the marketplace if we can do that. Great. Then one more on flu. Obviously you're going head-to-head. Could you talk about that trial, the timing, and then what you're expecting for tolerability head-to-head? You know, I think, for the flu, it's a high priority program. It's a Lightspeed program, just like our Comirnaty program has been and will continue to be. We're bullish. You know, we're in, you know, the midst of our phase III. We'll look forward to, you know, seeing results of that, both on immunogenicity, particularly on the efficacy side. If we do see, you know, a profile that confers some superiority, I think there's a real, you know, market opportunity, you know, first and foremost. Of course, you know, that sort of blazes the trail for a combination, which will be really, really important in the marketplace, you know, as I was saying earlier. That's sort of, you know, how we're thinking about the program. We'll hope to have, you know, results, as I said later this year. Then we'll talk about that. I think, David, you might have asked a second question in there, and I'm just not recalling what the second question was. Yeah, just on tolerability. Yeah. you know, many patients complain about, you know, the first 24 hours after their Comirnaty shots. Yeah. Yeah. I think it's first and foremost, it's really hard to compare, right, between the two. There's many, many dynamics at play that you sort of need to, you know, keep in mind as we think about this. You know, I would say, you know, first and foremost, we're, you know, focused on making sure that the profile that we have has a really strong balance, right? We're aiming for a strong, you know, efficacy profile, and then we have to balance that with safety and tolerability. I do think our goal is to find that right balance. Whatever, you know, ultimately leads to that right balance is what we'll move forward with. I do think it's hard to sort of make comparisons. It's just still very early. I think, you know, if we do get that sort of profile that we're aiming for, then I think that we don't see that being a limiter in terms of uptake, and frankly, you know, allows us to potentially take a leadership position. That's the way we're thinking about it. Excellent. All right. Great. Maybe we'll pivot back to Andy. Pfizer's biggest pipeline opportunity is oral GLP-1, it'd be great to start there. And you've talked about potentially a $90 billion GLP-1 or incretin market in 10 years and potentially $10 billion for your orals. Can you break down how you're thinking about that $10 billion figure? Actually, if you can remind us, is that $10 billion for 2030 or $10 billion in 10 years? Then how you're thinking about ex-US versus US, just because the current market players, you know, can barely launch ex-US since they have manufacturing constraints and will probably not be able to serve the world with injectable products. We're happy to speak about our exciting GLP-1 programs. We have two programs, right, danuglipron and then PF-1532, which we now refer to as lotiglipron. We believe that it's gonna be a $90 billion market opportunity in the US. That's in 10 years, so a little bit beyond 2030, across Type 2 diabetes and obesity. We believe that oral GLP-1s will take 30% of this opportunity, and a Pfizer oral GLP-1, either danuglipron or lotiglipron, could garner about a third of that oral segment. The math calculation here is 30% share of $90 billion and then a third of that, you know, $27 billion. That gets you to about $9 billion in the US. Globally today, 90% of sales of GLP-1s occur in the US, given price realization and market access. We expect about 10% for international, assuming nothing changes in that dynamic. That's how we get to our $10 billion global opportunity for a Pfizer oral GLP-1. That said, we believe the international opportunity could be substantial. Price realization and access are both the key. Obesity particularly is still viewed as a lifestyle condition by many, and coverage from national payers is generally very limited to a small subset of the obese population. Of course, over the coming years, we're gonna work with key stakeholdersHelp understand and make progress on the medical necessity of addressing obesity, just as progress has been made in the US. We think that that's gonna help. Of course, there's always the private market, internationally as well. Hopefully that gives you some color of how we're thinking about this. Yes, that's very helpful. Then how are you thinking about pricing for orals versus the injectables? We're, you know, obviously aware that we're, you know, not the only player out here, so we're not gonna be setting the price paradigm. We have time between now and when we would anticipate launching to kind of observe the dynamics both in the injectable space as well as there already is an oral GLP-1 out there. We'll look at the contracting approach and be mindful of both what a list price and then what a net price realization likely would be. Depending ultimately on how our profile stacks up relative to the other competitors out there, we'll make our final decision. Not too dissimilar from the way we think about setting price in other therapeutic areas. That's very helpful. Just one other question on it. Regarding 1531, the once daily, could you comment on full agonism versus partial agonism since Lilly has said it prefers partial agonism? Then with respect to additional potential disclosures in 2023, should we expect, you know, detailed phase II data for 1531 soon? Yeah. It's I think it's 1532. Sorry. Okay. We're calling it now. Okay. The phase II studies are ongoing. As soon as we get results, then we'll be disclosing them in a timely manner. I don't wanna commit to 2023, more likely 2024. Mm-hmm. Don't hold that. In terms of agonism, right? Pfizer's molecules, both lotiglipron, PF-07081532, and danuglipron are full agonists of the GLP-1 receptor. Just as all the currently approved injectable, peptide-based GLP-1 receptor agonists are. Full agonism is a measure of the molecule's ability to activate the receptor, which is believed to be tied directly to efficacy. Full agonists have been shown to produce a robust response even when less than 100% of the receptors are occupied. We believe that the full agonist nature of our oral small molecule candidates are responsible for the dose-dependent responses that we've seen in weight reduction in the clinical studies so far. We expect to see that as we explore higher doses, which is what we're doing in the studies right now. We believe that full agonism may be required for oral therapies to achieve the same efficacy over time as currently approved injectable GLP-1s. I don't wanna comment on views of others here, but that kind of reinforces what we have and why we believe it's the right approach. Yeah. I'm sorry, I had misspoken. With regard to PF-1532, yes, you've conveyed to expect results, you know, from your phase II early next year. I actually meant to ask, should we expect any additional phase I disclosures, this year? Let me get back and check on that. There might be in some scientific conferences later this year, more disclosures about 1532. It won't be the phase II data. Okay. Yes. Got it. Okay. Perfect. Great. Well, we're actually starting to run out of time here. Let me just pivot to another question. I've got so many I don't even know what to choose from here. You know, maybe Navin, since we have you, I'd love to hear a little bit more about your longer term vision for mRNA. For example, can you comment on self-amplifying mRNA, you know, and how you see that potentially playing out in coming years and also other therapeutic areas that you're pursuing, in terms of your mRNA R&D investments? Sure. I think, you know, with regard to self-amplifying, we are, you know, still in a phase I status, right. We're, you know, I would say it's early days. We are, you know, definitely very bullish on sort of the technology and the platform as part, first and foremost, in the short term, as part of our broader influenza, you know, vaccine program and goals. Our goal is to really, you know, do what we're doing in the sort of modRNA space, right. Which is develop a quad vaccine with potentially game-changing, protection against influenza. A similar, I would just say, overall objective as we think about our first, you know, saRNA efforts. Again, we would wanna try to get to something that's not just game changing in terms of protection, but, you know, ideally also leveraging the SA platform, the ability to get to even more favorable tolerability, right? That's sort of like the, I would say, the bull's eye. You know, potentially with saRNA because of the benefit, right, of having lower amounts of mRNA, perhaps there's opportunities to go beyond the quad, you know, model and platform and potentially include additional, antigens, right? As we think about, you know, driving even more, impact, I think is sort of how we're sort of thinking about that. Then just in terms of the study itself, you know, we're looking at multiple, dosing. You know, we have basically, I think, a variety of dosing, including, you know, 1 mcg, 2.5 mcg, 10 mcg, as part of that program. I think we're excited about it, still very early, and we'll look forward to sharing more. I think just our overall manufacturing platform also provides all of the differentiation that we've, you know, seen it confer to the mod platform. Most of that infrastructure is very fungible. You know, we can leverage that same agility that we've had with mod to the saRNA platform as well. Just I know we're running out of time, but, you know, I think your other question was about other areas that we're excited by. You know, just in the 30 seconds I probably have, we're very excited about the other therapeutic areas. You've heard about our Beam Therapeutics arrangement, in vivo-based editing, for multiple targets in rare diseases. That's where we're very excited on progressing there. Of course, looking at other applications across other therapeutic areas. You know, the leadership again, that we've seen, I think provides us with a competitive advantage in whatever therapeutic area that we decide to enter. Look forward to sharing more as we have it. Phenomenal. That's great. Well, appreciate you covering a lot of ground. Thanks so much again for being with us here today. Thanks for bearing with me as I was typing away. Hope you have a great rest of the week. Thank you. Thank you. Thanks again.