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Cowen Health Care Conference

Mar 7, 2023

Moderator

I'm back again this year. Representing the company is Angela Hwang , who's our Chief Commercial Officer, President, Global Biopharmaceutical Business. Annaliesa Anderson, who is Senior Vice President and CSO of the Vaccine Research and Development Operation. Rodrigo Puga, who is U.S. Commercial and Global Business Leader for Internal Medicine. I'd like to turn it over to Christina, who's also here on stage, to read the disclaimer.

Speaker 6

My favorite part. We're gonna be making forward-looking statements during today's call. Any statements we make are valid only as of today, and we undertake no obligation to update them in the future. If you have more questions on our forward-looking statements, you can see our SEC filings under forms 10-Q and 10-K, under the sections on forward-looking statements. With that, let me turn it over to my colleagues. Thanks.

Moderator

Angela, I think you wanted to make a few opening comments, and then we'll get underway with the Q&A.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Great. Thanks. Well, good morning, everyone, and thank you, Steve, for this opportunity to be here today and to be able to engage in what I know will be a very lively discussion about our portfolio here at Pfizer. If I could have the first slide, please.

Moderator

Sorry, one second. Back to full volume.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Thank you. Steve, I thought I would start by just taking a look at the Pfizer's growth narrative. I think it sets an important context for the discussion we'll have today and, you know, and provide the rationale for how we're making the decisions that we're making and why. I think we've always talked about our growth, I think, in two parts, right? The first is the 2020 to 2025 part, where we said we plan to be growing at a 6% CAGR. So we're on track to deliver that. That's the first bar that you see here. That's the $52 billion that we plan to deliver in 2025, which will accomplish this growth of the 6% in the first half of the decade.

There's always been lots of questions around what happens in the back half of the decade, and this is where I wanted to show you how we're thinking about our growth and what is our plan to growth. We all know and acknowledge that there is LOE, and there's $17 billion of LOE that will occur after 2025. However, questions around can you mitigate that and how do you grow beyond that have always been there, which is why I wanted to show you how we plan to step through filling that $17 billion, but in fact, going beyond that to deliver incremental growth. The first comes from bar number one, which is labeled at $20 billion. That growth comes from the 19 products that we are launching between now and in the next 18 months.

These 19 products are largely de-risked. There are a couple in there, such as the flu vaccine, that is not de-risked yet. We see a path to delivering this first $20 billion because these products are already being executed and marching towards launches. I think that that gives us the confidence, first of all, that we can mitigate the first $17 billion of losses. It goes beyond that. We have another bucket of growth that comes from business development, and that is the $25 billion box that you see. This box also we have begun to execute on already.

If you think about the four deals that Pfizer did in 2022 in the form of Arena, Biohaven, GBT, as well as ReViral, they form the substrate of growth that gets us $10.5 billion there. We still have a ways to go in terms of filling that bucket of $25 billion, but you also know that we are very active on the business development front, leveraging the firepower that Pfizer currently has and are very active in the space of looking for additional deals that will help us to fill in that gap. Again, we've already shown you that we are well on this way. We've executed four of those deals already, and we already know what those revenue contributions are gonna be.

We feel good about the fact that the plan works, and that we're gonna be able to continue to do that to fill in the rest of this box. If you just do that alone, that already gives us $70 billion by 2030, which is that next 6% CAGR that we're looking at for the back half of the decade. That's not where it ends, because we also know that Pfizer has a very deep and rich pipeline, and the value of that pipeline is reflected in that last box, the hashed box, where we know that there is incremental revenue and incremental growth that will come from our pipeline.

If you take what we already know, which is the 6% CAGR in the back half of the decade, add what is to come from the pipeline, that should give us then more than the 6%. That's how we see the growth of the Pfizer portfolio, in the next several years. Specifically, you can see that I only talked about the non-COVID products, because I wanted to make sure that we have a clear view on what that portfolio looks like. Of course, we also have the COVID portfolio in the form of Comirnaty and Paxlovid. For those of you who joined our Q1 earnings, we laid. Actually, Q4 earnings that we did in January, we gave guidance for, you know, for this year.

We also took a look at some of the assumptions that we believe will play out for COVID. We looked at assumptions for Comirnaty, vaccination rates, market share. We looked at assumptions for Paxlovid, where we looked at infection rates, treatment rates, market share. That formed a perspective on what we think the COVID franchise is going to be worth to us over the next several years. Clear from there is that this is enduring business. We have an opportunity to continue to create value both in the form of vaccinating individuals as well as treating individuals infected with COVID. I think that this is an important contributor to our overall portfolio. There, if you just look at the assumptions that we shared in Q1, again, they're all assumptions, right?

Things could change. You could get different infection rates. You could, you know, a number of things could happen still in the marketplace. If you just take what we said as assumptions, and you play that out, you get to a market, an opportunity that is that could be up to $30 billion in COVID. That's sort of like what the longer term looks like. We're also we also gave guidance in into January about what 2023 is going to look like. You may recall that we talked about 7%-9% growth in 2023 coming from three contributors, three growth contributors: the in-line portfolio, the new launches, as well as the new products that we acquired from business development.

All of those three is what drives us to the 7% and 9% growth. I just also wanted to say that when you think about that growth, we think about it being phased, you know, The way that it's going to be phased throughout the year is one where Q1 will be the lowest quarter. The growth accelerates as you move throughout the year in the subsequent quarters.

A lot of it is driven by, again, you know, just, things like the fact that the launches are coming in the back half of the year rather than the first. There are some gross-to-net adjustments that we always do in Q1. You know, there are items like that, the fact that we're transitioning from Prevnar 13 to Prevnar 20, there's some inventory adjustments. Those are all the reasons why, the earlier quarters are gonna be slower, but it picks up speed as we move throughout the year.

Moderator

Great.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Yeah.

Moderator

Thank you. By the way, if there are any questions throughout the discussion, just raise your hand, and we'll call upon you. Angela, let me start out by maybe asking for a little bit more detail on some of these boxes. When we look at the $20 billion dollar box that represents 19 launches in the next 18 months, what would you say are the most important three? What three are most important relative to your organization getting right to come close to achieving that $20 billion?

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Yeah. Steve, when we are looking at the size of growth and the scale of growth that we need, I think, all 19 of them are actually really important. Maybe I'll answer the question differently and from the perspective of maybe not what's important, but what's interesting about these launches. These- I'll pick three that I think are very interesting because they demonstrate the kind of growth mindset and value creation that we believe these assets can have. The first one I'll talk about is elranatamab, right? We think that this is an incredible program because it is, number one. Well, it serves an incredible unmet need in multiple myeloma.

Beyond that, the program that we're designing is one that is really value creating because, number one, it is large, it is comprehensive, right? We have four indications. Our plan here is to take this molecule and be able to participate in every line of treatment for the multiple myeloma patients. Our expansion opportunities, you know, they continue to evolve through the life cycle of this program. We're able to capture patients, more patients, but also earlier in their treatment as we move through this life cycle program. In addition to that, we can also participate both as a monotherapy as well as in combination therapy with current standard of care as well as future therapies.

You know, that just, you know, hopefully that gives you a sense of you take elranatamab, but where could you go with that, and why this is such a huge value creator and why we're so excited about it. Another one that I'll talk about is RSV maternal as well as adult, right? The RSV franchise. Another one that's very interesting, because it is a highly underdeveloped area and one where there is a tremendous amount of underdiagnosis today.

Another reason for us to be excited because of the growth potential. Right. Today, we know that there is no RSV vaccine, but we have 61 million 65-year-olds in the U.S. that are eligible for vaccination with the RSV adult vaccine. You have 4 million more adults and elderly or 65-year-olds aging in every year. You couple that with 4 million babies being born every year and the infants, and you start to see the ability for us to create and develop a whole new market for RSV.

Those two together are a blockbuster opportunity. Again, just I think that, you know, many, many ways that we can continue to develop this market and really establish the RSV vaccine, both in adults and maternal. Finally, I think Nurtec is another great example of value creation and how you take something and make it more than what it was. Maybe for that, Rodrigo, do you want to talk about that since you head Nurtec?

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Sure.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

The exciting things that we've done and why we think that what we got, we are able to expand and create more value.

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

For sure. Thank you, and glad to be with all of you. We are super excited about the Biohaven acquisition and Nurtec in particular. We finished the transaction in October last year, and since then, what we are doing is we are basically amplifying Nurtec and taking it to, you know, new heights. As you know, Biohaven was mainly focused in neurology and only in the U.S. What we are doing is leveraging all our scale, and I'll give you a few examples. We are, we have increased the number of physicians that are being called with Nurtec, and now we have 72,000 more physicians. I'm glad to report that already 20% of the new prescribers are coming from that new base.

A good example of, you know, our ability to, you know, bring products to the primary care setting. We are also working with our key account management organization, working with the 250 leading healthcare systems in the United States in order to find opportunities to improve the migraine pathway, the migraine treatment for those patients. We have very, very good results in doing that with other treatments like ELIQUIS, and we are going to, you know, leverage that capability. We have increased eight times our field medical colleagues that are working to deliver the science that this new migraine treatment brings to patients. These are just some examples. On top of that, we are bringing Nurtec to the rest of the world because as I was mentioning, it was only launched and focused in the U.S.

Since the, you know, last part of last year until now, we have 25 markets where the product is approved. As we speak, we are launching. We are starting to have conversations with the reimbursement agencies, very excited about that. China, it's another big opportunity. We have already submitted to get an acute indication in China, where we have more than 130 million patients suffering from migraine. When we see the dynamic of this market, it's the fastest-growing class, the oral CGRP. You can see that treatment, treatments are going down, that we, you know, the monoclonal antibody CGRPs are stagnant. The fastest-growing class, actually growing around 60%, is the oral CGRP, where we have the market leader.

We have around 50% of share, and we plan to continuing increasing that leadership. Very excited about that. That market last year was around $1.5 billion. We have half of that. If you fast-forward that with, you know, the growth rates that we are seeing now, we see an opportunity of around $6 billion for that franchise. Because on top of Nurtec, we are expecting very soon to hear back from the FDA about a second CGRP asset that will be the first and only intranasal CGRP. The drug is zavegepant. With that, we are going to enlarge our portfolio. You know, very excited about the CGRP opportunity, and we see a $6 billion big revenue opportunity there.

Moderator

Let me follow up on a couple of these assets. Clearly, Pfizer is bringing a lot of clout to the migraine market. But your principal competitor, AbbVie, was here just 45 minutes ago and pointed out that you had roughly half the market when you bought Biohaven, and you still have roughly half the market, despite all these resources that Pfizer's bringing to the table. Why hasn't Pfizer started to gain traction? Is it too early, or is AbbVie just too resilient? What's going on in the marketplace?

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Well, if you see the market, we started to collaborate, you know, mid last year, we saw a pretty significant increase in our market share during the last half of last year. I think if you see the TRX numbers, we keep growing leadership and we are planning to sustain that, basically.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

I do think we've had impact. If you look at the market share growth, the volume growth, and just even just the growth vis-à-vis the class. I think on every measure that we can look at, I mean, there's growth.

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Maybe one additional measure that I can provide is, and I was reviewing that last week with the team. If you see the new prescribers and what is the first choice for new prescribers, in 80% of the cases, the first choice is Nurtec. The reason is it's an incredible product. It's the only product that is approved for both acute and prevention, and that gives a very convenient advantage to physicians and to patients to be able to flex the use of the new medications.

Moderator

Let me follow up on RSV with you, Lisa. We assume, investors, I believe, assume that the Pfizer and GSK vaccines are basically co-competitive. You probably disagree, so tell us why that's not correct.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

We're very proud of, our RSV vaccines, both for the adult and the maternal. I think that's a big differentiator.

Moderator

Right. Well.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

The fact that they'll

Moderator

Granted, that is.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

You know, we saw very high efficacy against severe disease. We used an objective pre-specified criteria to actually define what the severe disease was. We also see a very strong safety profile in the fact that, you know, if you compare the placebos participants with the vaccinated participants, there really wasn't any difference for the participants who took the pre-RSV F vaccine. We think we have a very strong safety profile in addition to the strong efficacy profile. We're really looking forward to the May timeframe when we'll be accept, you know, expecting the PDUFA timeline approval and the subsequent ACIP recommendations.

Moderator

To what do you attribute the fact that Pfizer was successful in maternal and GSK had to stop their program? What about these vaccines is different that led to that dynamic?

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

We can't necessarily comment on another vaccine. I think, you know, we conducted an extremely large study that was a global study. We had a lot of, you know, monitoring along the way with how we were enrolling the pregnant women, how we were monitoring the pregnant women and, you know, accurately determining, for example, the ages of the babies at time of birth. So, you know, again, I can't comment on another vaccine, but what I can say is, you know, we conducted a very stringent study.

Overall, when you looked at, you know, the amount of preterm births, we had very similar amounts in the vaccinated group versus the placebo group. We didn't see any imbalances in survival for babies. We're very confident that we have, you know, a highly effective vaccine that's gonna have an enormous impact on burden of RSV disease for babies, you know, in the U.S. and globally.

Moderator

Let's stick with babies. Sanofi and AstraZeneca talk a lot about nirsevimab. Tell us why a baby should get the- or the mom should get the vaccine and not the baby get nirsevimab.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

You know, maternal vaccines are, you know, a perfect example of, of how nature works and the fact that, you know, the mother transfers her antibodies to the baby, it's called the mother's gift, in the late stage of pregnancy, and the baby is born with the same level of circulating antibodies as the mom has. If the mom hasn't been exposed to a pathogen, she won't have the antibodies, but if you vaccinate her, she does. Why is that important? You know, a baby is susceptible to RSV from the first breath. When you know, have your new baby, even in hospital, as you've got people coming to visit, especially young siblings, an RSV infection happens very, very quickly. Yes. It's not something that kind of takes time to develop.

You will come into contact with someone with RSV, and you'll become infected. Newborn babies are particularly vulnerable to the severe outcomes. They can't tell you that they're having difficulty to breathe. Often, yeah, it takes an expert to be able to measure, you know, what's going on and be able to say, "Yes, you know, your baby's in severe distress," at which time it's then hospitalized. We think that there's real medical value in having a baby protected really from, as I mentioned, the outset from that first breath.

Moderator

This gets back to adult RSV vaccines, but would you like us to contemplate a situation where Pfizer gets a preferential recommendation from ACIP?

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

From, ACIP recommendation, it's very rare.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Mm-hmm.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

That you see preferential recommendations for vaccines that have clear medical benefit. From our perspective, we've had a couple of interactions with the ACIP more recently in two weeks ago, where they've been very positive about our vaccine, and we haven't seen any indication for the potential of preferential recommendations at this time.

Moderator

Okay.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Steve, I agree with Lisa, I think that we think about what else you need beyond the clinical profile to have a successful vaccine. I would say that both RSV adult and maternal really fall into the sweet spot of what Pfizer does, right? Think about our leadership and the capabilities we have in adult respiratory diseases, both vaccine and treatment. You know, began with what we had in Prevnar, and then further reinforced by the tremendous successes and the strength we have in the market from Comirnaty and Paxlovid.

I mean, the primary care setting, the retail setting, urgent care, I mean, just every primary care and community setting that you can imagine is a stronghold for Pfizer. That's one. If you think about pediatrics, think about women's health, again, areas of great strength for Pfizer. I think, what we have is a combination of a great vaccine, but also incredible commercial capabilities that are already well established and an engine that's already functioning, that we can put both of these vaccines into.

Moderator

Questions from the audience? If we reflect back on the slide on the screen, I'm always intrigued by Black Box. I know it says in the footnotes that this graph was not drawn to scale, but whoever drew it did a really good job. X is not an insignificant box. I mean, it looks like $10 billion-$12 billion, right? What is in Black Box?

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Let's start with 1. Rodrigo, you wanna talk about GLP-1?

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Yeah, I.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

That's in box X. Lisa, you could talk about flu COVID combo. That's also in box X.

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Sure. One of the products in that box X is our potential GLP-1 asset. We are very excited because we are developing two assets, danuglipran and lotiglipran. As we speak, we are running two phase IIb studies for each of the molecules. We're expecting to have the readout for danuglipran at the second half of this year, and for lotiglipran, which is once per day, in the Q1 of next year. Based on the results, we will be able to decide which one to, you know, move forward to phase III.

The good thing about these two molecules is they are full GLP-1 agonist, We believe that this is very important to create the dose dependent in terms of getting the right efficacy, because we believe that if we are able to bring to the market an oral GLP-1 that has, you know, similar level of efficacy compared to the available injectable GLP-1 with no food restrictions, because today we have one available GLP-1 in a normal formulation, but it has, you know, significant food restrictions. We have the opportunity to create a $10 billion+ opportunity. The math behind that is the market is growing, currently growing at 30%. We believe that by 2030 that market is going to be around $90 billion.

We think that oral GLP-1s will capture at least one-third of that market. With the profile of product that I am mentioning, plus our legacy of building blockbusters and our impressive primary care footprint, we believe that we can take one third of that market. If you do $90 billion, one-third is $30 billion, and we think that we can take, well, you know, $10 billion. Part of the answer for that Xbox is GLP-1. We are waiting to hear, you know, from the results of the clinical trials, but we are pretty confident because we have two strong molecules in development.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Yeah.

Moderator

Let me just follow up on this point. My colleague Mike had a diabetes obesity panel yesterday morning, and the doctors were skeptical that an oral GLP-1 will have the bioavailability sufficient to come anywhere close to what an injectable GLP-1 can deliver. Tell us why that doctor's wrong. Those two doctors were.

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Well, you know, I am not a scientist, but what I can say is that the early trials that we have in phase I and phase II are showing very significant level of efficacy, both in terms of glycemic control and body weight reduction. We are very confident. Now in the current clinical trials that are ongoing, we are testing different doses for both assets. Because they are full agonist, we believe that if we can get to the higher doses, we will be able to get similar efficacy to the currently available injectable GLP-1s.

Aamir Malik
Chief U.S. Commercial Officer and Executive VP, Pfizer

If I can add to that, Steve, during the conversation, they were focused on Rybelsus, so oral semaglutide, which is peptidic and has low single-digit bioavailability, even with the carrier that it's in. As Rodrigo said, we're a true small molecule agonist. That means we have a very, very high bioavailability. Even beyond that, as you said, we're a full agonist.

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

Sorry, Steve, I made a mistake. The flu COVID combo is not part of that box, but it's beyond that box of-

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

Yes, I'm happy to talk about it. We started our flu program with mRNA in before the COVID pandemic, really with an eye to have better flu vaccines. Currently, flu vaccines are between 40% and 60% efficacious every year. Even worse for older adults. This year, the efficacy for older adults was 35%. Knowing that, we felt that we could do much better. The issues behind, you know, why those vaccines aren't very good include the fact that there's a long lead time to picking which strain is gonna cause disease, and they're often wrong, or the strain will change during the season. Also, many of the vaccines are made in eggs, and this means that you're making a vaccine that would recognize a chicken egg virus, but not necessarily how the virus behaves when it infects you. That was our first goal, was really to develop better flu vaccines.

COVID came along, we switched our work on our RNA with flu and moved over to COVID in partnership with BioNTech. You know, you know the story there. Now as we look forward, you know, we're looking towards and we're predicting that, you know, we're gonna have at least annual COVID vaccinations. You know, how many vaccines do people want to take? And really we see for adult vaccines, as that we saw with pediatric vaccines, is the future really is going to be in combinations, particularly for these annual vaccines that are gonna involve strain changes. Working with, you know, we currently have our efficacy program for the monovalent flu vaccine ongoing. We expect it to read out later this year. We've also started early work on a flu COVID combination vaccine, which is, as Angela said, not predicted in the Xbox, but something that will be coming forward.

Moderator

Okay. I believe we're out of time, but I'd like to ask one last question, and I'd like to ask it to Angela, and it will have to be just one sentence answer. You have some perception of where investors believe Pfizer will be in 10 years. You know more about where Pfizer will be in 10 years than we do. What is it that we don't get? Pfizer's going to a level that we don't understand. What is it about that level?

Angela Hwang
Chief Commercial Officer and President of Global Biopharmaceuticals, Pfizer

I think that it's in those boxes, right? It's the fact that we have products and where we see the potential of growth of those products, and I described three, those three specific ones, 'cause it goes to show you how there are a lot of assumptions in terms of how you think about that opportunity. Those three alone are massively expansive opportunities where you can go much further than where you started. I think that that's where maybe some of that miss is. It's just sort of how where we see the programs going, the populations and the targets and patients that we think we can, we can meet and how you're thinking about it. I think there's that one.

I think that in the BD box, there's also a miss there. I think Rodrigo painted a great picture about how we see Nurtec. We see Nurtec as a $6 billion opportunity. I don't think you have that right now. I mean, if you think about the fact that today only a billion people have migraines, 12% of them today are using an oral CGRP. That gives you the extent of growth that's possible. I think that it's the way we look at it and the confidence that we have in our ability to scientifically expand to broader populations and then commercially being able to get that business, allows us to think about these opportunities in the way that we do.

Moderator

Sounds like a great future. Thank you for telling us more about it and thank you for being here.

Annaliesa Anderson
Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer

Thank you.

Rodrigo Puga
Senior Vice President and U.S. Business Lead for Internal Medicine, Pfizer

Thank you.

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