Great! Thank you very much for joining us today in post-lunch session. We'll keep it entertaining so that you don't, but yeah. Thank you very much, and my name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and we have Pfizer management team today with us. We have Annalisa Anderson, she's the SVP and CSO, Vaccine R&D, and Rodrigo Puga, he's the U.S. Commercial and Global Business Lead at Internal Medicine. And we also have Chris Stevo, Head of IR at Pfizer. Thank you all for joining us today.
Mohit, if I can just briefly make a forward-looking statement, then I'll let you all get to it. So I just wanted to inform you that we're going to be making forward-looking statements or may be making forward-looking statements today, and anything we say is only valid as of today. And, if you have any more questions on forward-looking statements, please see the relevant sections in our SEC filings under Forms 10-Q and 10-K.
Great. Thank you very much. A lot of questions on, like... I think, we are really lucky to have both of you because I have two pages full of questions, but if you have any questions, please, please, please let me know. And, yeah, I mean, Chris has set me up so that I don't ask questions to him. So-
We can always send them over, though.
Yes. He does that throughout the year anyways. So maybe with RSV, look, now that the data are out, and we know the competitive profile of different assets that are out there, what has been the feedback from the payers and prescribers so far, when they compare, Abrysvo versus GSK's product at this point? I mean, what are you hearing?
So, we're very confident about Abrysvo, our vaccine. You know, it's a vaccine that's now broadly approved across older adults and the maternal population. And, you know, we had extremely powerful efficacy results. The efficacy study was conducted in, you know, over 35,000 individuals. And we looked at very objective endpoints that really showed that someone had severe RSV disease, and we saw very good efficacy. We continue to see efficacy as we go through the second season. So first of all, very, you know, efficacious vaccine from that clinical study. Also, a large safety database and very safe. We haven't seen, you know, any kind of when you compare it to other vaccines, the reactogenicity profile is very straightforward. There's no adjuvant or anything else that might cause the vaccine to cause more discomfort.
Then the other piece is, which is, you know, obviously important for providers, is that it's very easy to administer. It is a lyophilized vaccine, which means that it's made as a powder, and then you reconstitute it with a liquid to administer it. The way that we do it is we have a special adapter that we've used for other Pfizer products, and works well, to link the two pieces together so that you can then reconstitute it. So there's none of this kind of playing around, stabbing things with needles and pulling things up and down with needles. So it's much, much simpler than the traditional reconstitution approaches. So we think that that makes it a much more user-friendly vaccine as well.
So when you think about the drivers for a vaccine adoption, I mean, this is a newer market for vaccines. What is more important? I mean, like, there's physician and patient preference as well, but how much contracting plays a role here? Because, I mean, contracting is one area where, you know, we saw with Pfizer COVID vaccine as well, where you really did well. So how much does this play a role here?
So, yeah, I'm not in the commercial organization, but obviously, we have a very strong commercial organization.
Sure.
A lot of the COVID, you know, contracting was done, you know, through governments. But, you know, we certainly have experience with global contracting of vaccines and other products. You know, we've had Prevnar in doctor's offices for over 23 years now, and with the RSV vaccine, it provides obviously opportunities to expand, you know, our footprint in pharmacies as well, and we're currently, you know, distributing the vaccine across different pharmacies in the US. It's being taken, and we're really, you know, looking forward to seeing the effect that RSV vaccination has on reducing severe RSV disease.
Got it. This is helpful. Maybe, maybe moving on to flu. I'm sorry, I have a lot of questions here to go through. Sorry about that. Thanks, Serena. So, moving to flu vaccine here, I mean, so, Moderna ran into an issue with their phase III studies, and they talked about differences in prior immunization history in Southern Hemisphere that led to not meeting the non-inferiority against the B strain. What—like, how are you thinking about that? What can you do to mitigate that, and what is the difficulty in driving the responses to B strains?
So there's two ways to license a vaccine, so I'll start with that, for flu. One is to show non-inferiority against an existing vaccine, and I think that might be what you are referring to. The other is to do an efficacy study. So when we looked at our early stage results for our flu vaccine, what we saw was, you know, very, very strong, A responses that were, you know, improved from the standard of care. Our B responses were kind of similar, maybe a bit lower than the standard of care, from the B cell perspective, but from the T cell perspective, we saw extremely high and robust T cell responses. T cells are associated with protection against severe disease and also memory.
Rather than go into an immunogenicity study to look for non-inferiority, which, you know, other companies may have done, we then went and did an efficacy study so that we could really determine whether or not those T cell responses were going to have a contribution towards efficacy. So we started that study last fall, and we conducted it in the U.S. The U.S. had a very low incidence of B strain disease, and so we continued it into the Southern Hemisphere. The study's ongoing, it's blinded, so I can't tell you how it's doing, but, you know, later this year, we should have more news that we can certainly share.
Got it. And when you think about the efficacy of flu vaccine with an mRNA approach, how do you think about what is the bar? Is it? Should it be similar to other protein-based vaccines, or should it be higher because it's a new modality?
Current flu vaccine efficacy isn't very good.
Right.
Yeah. You're looking at between 20% and 60%.
Right.
That's overall. So if you look into certain populations, such as the elderly, the efficacy some years may go down, and there's a number of reasons for that. You know, most flu vaccines are made in eggs. It's a long, slow production process. So if you're in a situation where a vaccine, well, an infectious strain changes during the year, you can't keep up with it. Yeah, so essentially, the flu vaccines are, you know, declared in February, and essentially after that, they're then made ready for the winter season. So it's a long process. RNA vaccines have the ability to be made in 100 days. Yes, we've shown that with COVID. And so there's more flexibility. You can wait until you actually pick a flu strain, as opposed to having to do it early.
So if you see changes, you can maybe adapt with that, you know, pending WHO and other authorities making that decision. Also, flu vaccines, you know, are made in eggs, and so think about a virus. Yeah, so a virus made in an egg will look different to a virus that, you know, is made during infection.
Right.
Using an RNA vaccine, you have a much higher likelihood of having a vaccine that's displayed in a much more similar way to how it's displayed during infection, so you can get better antibodies. So there's a number of, you know, reasons why an RNA vaccine could be superior to a traditional vaccine before you even look at efficacy. So I think there are ways that, you know, the technologies differentiate. And, you know, when you think at the end of the day, a lot of people don't take flu vaccines. Just 50% of the population take flu vaccines, and the rest are like, "Well, you know, flu's not that bad," or-
Right
... "The vaccines don't work," or, "I took it, and I got flu.
Or they need a form like me.
Yeah.
Sorry, Mohit, maybe to add to what Lisa was saying, because I think this is a key point that sometimes people miss, is that she talked about the benefit of being able to choose the strains later, perhaps more accurately as a result.
Right.
The key point here is in both the Northern Hemisphere and the Southern Hemisphere, the strains we used in the mRNA construct were exactly the same strains that were chosen back in February, for example-
Right
for the Northern Hemisphere and the Southern Hemisphere at the appropriate time. This is not going to test that advantage. So any advantage from that would, of course, hopefully be additive to that.
Yeah.
Got it. This is helpful. Maybe moving on to pneumococcal vaccine, actually. Where do you go from Prevnar 20 here? And I know Merck is talking about their V116 program as well. How much benefit that, that one provides, and how does Pfizer continue its competitive advantage going forward?
Thank you for the question, Mohit. We've been in the, you know, pneumococcal conjugate vaccine business now for 23 years, and we've led the field.
Right.
Yeah, so we started with a 7-valent vaccine. There was competition at the time, but we, we were the only ones that came through, and really set the stage for, not only pneumococcal vaccines, but also kind of the concept of premium pricing for vaccines. We then went on and did the 13-valent vaccine. Again, heavy competition, which we were able to again maintain, you know, dominance in the market. And now we have the 20-valent vaccine, and, you know, we're not just suddenly saying: "Oh, okay, we're done.
Right.
And we haven't said: "Oh, we're not done. Maybe we need to do something." We've spent many years looking at, you know, what are our next steps after the 20-valent vaccine, and so we're actively working on, you know, our next, you know, reiteration of the pneumococcal vaccines. We're not ready to talk about it today, but we certainly will be talking about it later this year. But needless to say, you know, we're the leaders in pneumococcal conjugate vaccines. We have vaccines that provide the broadest coverage against, you know, devastating disease for both older adults and the very young. And, you know, we're looking forward to maintaining our leadership, bringing new innovative vaccines that are going to provide protection to the most vulnerable of our populations.
... Got it. So again, one question we get a lot is, like, I mean, right now, you are selecting for, for flu vaccine, you're selecting 6 months in advance. How important it would be? Like, how differentiated it could—how big a differentiator it could be that you're choosing a strain only 90 days in advance of the flu season? I mean, how... Like, can you help us understand that advantage?
Yeah. So it's not so much that we would be choosing to change a flu strain.
Yeah.
So think about it in terms of, you know, the WHO makes a decision on the flu strain very early. It gets ratified by different countries and governments, but then sometimes there's a strain change-
Right.
There's nothing that can be done about it.
Right.
Yeah. So by having technologies where you can actually change the vaccine and implement new vaccines, that's where the advantage is, in the fact that if the WHO were then to see that the choice was wrong, which sometimes, unfortunately, it is, there's an option to introduce another vaccine later on in the flu season.
Got it. This is super helpful. Maybe moving on to the internal medicine side of it. So let's just start with migraine here. So when Pfizer acquired Biohaven, or the Biohaven... Biohaven is still there, but Biohaven's migraine program,
Mm-hmm.
The idea was $6 billion peak sales. I mean, that was the... Like, have you talked about how you think about splitting, split of that $6 billion between Nurtec and Zavzpret, spray? And, and how do you see that growth coming? I mean, it's just like the market itself is growing, or how do you think about that?
Thank you, Mohit. So maybe I can start by answering your last question, and then I go to the first one. We do see that this market can grow 6x between now and the end of the decade, and the reasons why we believe that are basically three. The number one is, we believe that there is going to be more and more penetration of oral CGRPs, and oral CGRPs will challenge generics, meaning triptans and topiramate, as the standard of care. When you see the efficacy profile, when you see the really, really, really positive tolerability profile, we see more and more physicians and patients adopting that. We think that that is going to be discussed more and more in medical societies.
When you see the balance of what patients get today with a triptan, which have good efficacy, but for many patients, have to deal with a lot of side effects, and you compare that to oral CGRPs, we think that we have a fundamental, advantage, basically for, for patients. That's one source of growth. The second one is, coming from PCPs' engagement and, and penetration. And I think that the, the fact, the data point there is today, 60% of the triptans prescriptions are coming from PCPs. Only 30% is of oral CGRPs is coming from that same group.
We are working on a big part of our strategy, was to actually double the size of our reps and the educational effort on those physicians, because we think that specifically Nurtec ODT has a clear competitive advantage, being the only oral CGRP that has both, acute and prevention indication. It's very simple, the drug is very clean, if you want, and it's very easy to adopt for a PCP. So that's the second source of growth, and we are currently investing heavily on that. The third one is, basically, we'll continue to invest in educating and creating more awareness. We know that, there's 1 billion people suffering migraine, and we also know, based on research, that there are many, many patients on the sidelines.
For many years, they have dealt with this disease, and they basically think that they need to live with that. They have tried some of the available standard of care, and it hasn't worked very well for them, and they're in the sidelines. And we, a big part of our mission is to go and tell that there is hope, and I always talk about that because I am a patient myself, and I was in that situation. I suffer migraine, and for, like, five years, I said, "You know, there's nothing to be done," until I discovered this, this new drug and this new medicine, and it was life-changing. So these are the three sources of growth. Your first question was, Nurtec versus Zavzpret, and how do we see that?
We think that Nurtec ODT will continue to be the foundational treatment. It's the only CGRP with both acute and prevention. It's very simple to use, and it has a broad, broad range of, of, uses. So we'll continue to promote that. We'll continue to educate, as I was mentioning. And we think that Zavzpret can be a perfect complement to Nurtec. If you remember, migraine can be treated acutely to abort an attack, or you can prevent that to reduce the number of migraine days. The only molecule that is approved for both is Nurtec. Zavzpret is only approved for acute, but it's very suitable for patients that cannot swallow, that cannot take medicine, because it's the only intranasal CGRP, and that's a, you know, big benefit. And also, it has been seen that it has a very rapid onset.
So if you wake up with a migraine, Zavzpret could be a very, very good treatment for that type of patient. And when you study a little bit the profile of the migraine patients, many of them, unfortunately, need to work with what we call a toolbox. Sometimes not only one medication is enough, and that's why we think that Zavzpret can be a perfect complement to Nurtec for so many patients, and also a perfect complement to many other migraine treatments available in the market.
Got it. Got it. This is very helpful. That actually, you answered like three or four questions in one shot, actually. Thank you for that. Maybe moving on to the obesity franchise or obesity/diabetes franchise for you. Danuglipron has shown really interesting data at this point, like mid-single digit percentage growth. So how do you think about the competitive profile of this oral? And then, like, if you compare it to Lilly's oral orforglipron, it's kind of like close to 15%, at the highest dose, and it's a once-daily pill. So just think, like, let us just discuss a little bit about the competitive profile of the drug compared to what is out there in the same time frame.
Sure. So, I cannot comment on orforglipron because there's no head-to-head study, but we have the data-
Sure.
And we see it. So what I can share with you is that what we know as of today for danuglipron is only based on type 2 diabetes phase II trials.
Right.
And as we speak, we are running our phase II in obesity. So our main strategy is to wait until we see that obesity trial that will read out by the end of the year. And once we have the totality of the data of the three trials, we'll be able to inform hopefully our phase III decision and strategy moving forward. A couple of comments about how we designed and how are we pursuing this obesity trial in comparison to what we know today with the type 2 diabetes for danuglipron. There are two fundamental differences, which are in the dosing schedule and also in the duration of the trial. For diabetes, for type 2 diabetes, we went up to 120 milligrams, and in this study, we are going up to 200 milligrams.
The other thing is, on the type 2 diabetes trial, the duration was between 12 weeks and 16 weeks. Now we are going between 26 weeks and 32 weeks. When you add more doses, more time, it is likely to expect that we should be seeing some impact on efficacy in terms of weight loss, HbA1c reduction, and so on and so forth. So that's an important, you know, thing to consider. I think that the other factor that it's important to consider is that this oral treatment can be taken with food, and the available treatment today has, you know, significant fasting restrictions. And finally, one thing that we are doing with this type obesity trial is we are testing very different titration schedules, 'cause...
That's why we want to wait until the end of the year when we have the data. We are expecting that by phasing out and having more time for the patient to adopt the medicine and titrate up, we can see more tolerability with good level of efficacy. And we think that that, again, totality of the data will allow us to inform us, together with the already finalized, you know, type 2 diabetes trials, the best decision moving forward. The last thing that I want to comment is we are also exploring the opportunity to develop a modified-release formulation. And, you know, pending the results of the readout by the end of the year, should we decide to do that, we are very confident that we can progress that into the clinic.
Why we're trying to explore doing that is we don't know about this specific drug, but we have seen in other molecules that when you do that, you know, reduce the impact of that drug in terms of the gastrointestinal effect. And we know that particularly for this class, that is a big issue. So that's why we are exploring the possibility of having a modified-release formulation.
Got it. And from a manufacturing point of view, is this easier to? Is it a pure small molecule? Is it still peptide-based drug?
It's not peptidic. It's a true small molecule.
Okay.
Yeah.
Got it. Got it. Do you have any thoughts on developing a portfolio of these medicines in diabetes, obesity, or this is the-
Again?
The portfolio of multiple drugs, because, I mean, there are other companies like Amgen, like-
Oh.
People who don't know, and really, they are trying to develop a portfolio rather than just one asset. I mean, you had two, but again, one had safety issue. But how are you thinking about developing a portfolio there?
Yeah, we can clearly see some companies that, you know, have a portfolio. In the end, I think that, you know, it will depend on the clinical benefit of each drug, and we do see that this is going to be a very sizable market, and there's going to be opportunity for many different types of drugs. We don't believe in the one-size-fits-all, because when you think about, there are so many different types of patients, so many different needs in terms of weight loss reduction, in terms of the different tolerability profiles from the patient. So we celebrate, and we know that it's going to be a highly competitive market, but at the same time, we believe that there is going to be space for many different types of treatments.
We have seen that, you know, there are, you know, good news recently in terms of, you know, having cardiovascular outcomes, you know, different levels of efficacy from different combinations, monotherapy. We think that that is good because it's going to be good for, for the patients.
Do you think having those data helps with the reimbursement? Because we are hearing both sides. I mean, now payers are still even more skeptical or more like, you know, challenging it more than, you know, we don't want to cover it, versus, you know... Because now they are worried that it will be even bigger market than they thought before.
Well, we definitely think that it's great news for the patients.
Right.
... Because for many years, there was this conversation between, is this a lifestyle issue or this is a real healthcare issue?
Yeah.
This study that was recently published demonstrated a 20% relative risk reduction. That is amazing. It's showing that, you know, you know, these patients are dying less from cardiovascular disease, heart attack, stroke, so it's great news. We definitely think that this will create some new pathways in terms of access, accessibility, and will shape the conversation. I think that you cannot hide the data, and, and at Pfizer, we follow the science, and in this case, the science is there. So in any case, we believe it's a very positive event in this marketplace.
Got it. One question we get a lot is, like, regarding anticoagulants, so you obviously, obviously have Eliquis there. All the other players in this space, they're all continuing with something else, like Factor XI, so there is the... J&J is there, Bristol is there. Pfizer decided to scale back. I mean, can you... Like, do you have a plan to continue in that area, or, like, what, what is the thought process there to not do anything in, in, in that space?
So the way that I would respond to that question is, we are constantly evaluating every development in this area, and especially we have a huge legacy on the cardiovascular and metabolic area, so definitely we are interested and we are following again the science. I think that the main driver for us to pursue Factor XI, Factor XIa, it's how breakthrough can that drug be?
Right.
I think that until we don't see that breakthrough component, we are waiting and seeing and hopefully expecting that that will come. So far, the projects that we have assessed, we didn't see that breakthrough potential, and that's why... The reality is that the NOACs or Xa came to really solve a big part of the problem. And we are still seeing how, you know, many more patients are being prescribed for the first time on Eliquis. Actually, seven out of ten every new prescription is going to Eliquis. We keep growing in market share, getting patients from warfarin. So definitely apixaban is the standard of care in the category, and we expect to continue to grow.
And even after LOE, we have seen for other molecules, and we expect the same in this case, because we are already facing LOE in some emerging markets and what we call solo markets, where we have exclusivity, where Pfizer is alone. And those markets continue to grow after LOE, and that represents around $1 billion. So we expect that to be a significant revenue contributor even after LOE.
Got it. Got it. This is helpful. Maybe going back to the vaccine/COVID part of it. So, at the earnings call, it was mentioned that, if COVID sales do not or come below expectations, there could be some cost cuts to think about at some point. Do you... So, like, how would you think it, it'll be-- If it happens, would it be specific to COVID? How are you thinking about it?
So I think, you know, we're a large company, and we're always looking, you know, for ways that, you know, we can do our work most efficiently. You know, we're coming up to the next COVID season. In fact, some people would say it's already started.
Sure.
You know, we're looking forward to a potential approval of this next vaccine, the XBB.1.5. There's an ACIP coming up.
Sure
... very soon, which, you know, hopefully indicates when we'll get that approval, and we'll be able to start rolling that vaccine out. You know, we presented data at the VRBPAC earlier this year just to show how the vaccine did preclinically against XBB.1.5 and other variants. And, you know, it was much, much better than the bivalent vaccine, and we continue to monitor variants and show that the vaccine, the XBB.1.5 vaccine, is the better vaccine to neutralize some of these new variants, such as the 2.86 and others, as far as the neutralizing capacity.
So we're, you know, very excited about the data that we are generating with our vaccine, and we're looking forward to, you know, a potential approval and recommendation so that we can make sure that the vaccine's available to those who need it in the coming season.
Got it. That's helpful. Thank you.
Mm-hmm.
With regards to the cost cuts, and again, as Dave and Albert alluded to on the last call, you know, let's see where the fall COVID revenue realization comes out to and what that implies for future seasons. And then we'll be in a better position to talk about what kind of cost cuts would be appropriate as a result of that.
Thank you. One question I want to ask about the BCMA bispecific. So, I know, I mean, Pfizer, last year, December, you guys, for $4 billion opportunity there. The field is very competitive, so how do you think about the competitive positioning versus the other BCMA bispecifics? And then eventually, CAR T as well, because obviously CAR T is going to be a big player.... later on?
Yeah, I guess I'll, I'll take that question.
Sure.
So we're very pleased that Elrexfio got approved a few weeks ago. We think it's an excellent product, not just within the BCMA bispecific space, but in general in the multiple myeloma space. So we're very excited by the attributes of the product. So for example, it only has three days of hospitalization versus the other BCMA bispecific, which has six days of hospitalization in its label. As you know, the majority of multiple myeloma patients are treated in community centers, non-academic myeloma specialist centers. So they're not transplant centers, so this is a very binding constraint for them, hospital bedtime. So reducing it in half is a big advantage. We have fixed dosing. We have very simple dosing.
We have weekly administration that goes to every other week administration after 26 weeks, and we hope in other trials to get that potentially to even longer dosage windows. So you see there are a number of ways that make the product very friendly for the users and for the patients. And then in terms of the efficacy as well, we see very, very low rates of side effects, including severe ones like CRS or ICANS, which is very important for a whole host of reasons. So those are very well controlled there. And the part you don't see yet, which is the part that will be evolving, is how this can be used in combination. Obviously, multiple myeloma has a number of different backbone regimens, and we've started to generate data already with some of those different regimens.
The data we've seen so far suggests that it can be used very successfully with them. We've already started our frontline trials. We are gonna have trials in transplant-eligible and transplant-ineligible patients, using common backbones there. So that's an important part of it. And then, you know, there will be more work that we'll be talking about, increasingly with novel, novel backbones with Elrexfio. So, stay tuned. There's a lot to come there. So you've only seen basically the tip of the iceberg above the water for that $4 billion. You haven't, you haven't seen most of the story yet.
Right
... of how we're gonna get there.
Got it. So one last question for both of you. Fast-forward one year, September 2024, I hope you're all here. I hope I'm here. What would make you very happy looking back one year, and you'll be like, "This was a great year for us?
So, if I can start. So for vaccines, you know, by the end of the year, we're expecting to have, you know, a total of five approvals. No vaccine company has ever done that in, you know, recent history. And, you know, these vaccines are all targeting, you know, severe infections with high medical impact. And so from my perspective, this time last year, next year rather, you know, we have the maternal vaccine now for RSV. You know, thousands of babies die every year, globally, from this disease. And so to have an impact on that, I think will be, you know, very, very exciting. As well as, you know, our, you know, end of the year, we're looking at approval potentially of our pentavalent meningococcal vaccine. Many people take...
You know, children have meningococcal vaccines, and often parents don't fully understand that there's different types of meningococcal disease. And so there's a lot of confusion around whether or not their child has had all the right ones or not. And so to have a single vaccine with the ACWY and the B together, you know, should have a prospect of reducing that confusion. And, you know, when often, sadly, you hear that someone has died, for example, of meningitis B, the mother's like: Oh, but I thought my child was vaccinated. And so to remove that from society, I think would be very, very important as well.
In my case, I'll briefly talk about three things. For Eliquis, I think you know, it's one of the most successful medicine in recent history in terms of small molecules, and we have been able to help 10 million patients in 10 years, but the mission is not yet accomplished. We know that only in the U.S. there are around 3 million patients that have nonvalvular atrial fibrillation and are either undiagnosed or untreated, and we have a commitment to find every patient because they deserve it. Many of those patients discover the disease once they face their first stroke, and that is not acceptable. So I would be very happy if we can find a big proportion of them next year.
I think that, regarding migraine, it's so incredibly positive to have the opportunity to bring hope to patients that are on the sidelines, and we are working on that. We have a new campaign with, you know, real patient stories, and Lady Gaga is a true patient talking about-
Mm-hmm.
migraine, and we are sure and confident that that will bring many, many more patients, you know, to start treatment with Nurtec ODT. And then, September next year, I would like to see that we have a very robust phase III program for our danuglipron GLP-1. So that would be my answer.
Awesome. On that high note, thank you very much. Really appreciate you for joining us. Thank you.