Well, good morning once again, welcome to TD Cowen's 46th Annual Healthcare Conference. We're delighted to have you here. We're especially delighted to welcome Pfizer back to the conference this year, representing the company, Albert Bourla, who is Chairman and CEO. Albert, thank you so much for making the journey.
Great pleasure.
Lots to talk about, much going on internally to Pfizer, but also in the external environment. I'd like to start out with the external environment. Albert, you were front and center through the whole process of negotiating deals with President Trump. You were the first person to be in the White House to sign the deal. What surprised you most about that process and the outcome for Pfizer relative to the deal?
What surprised me the most, it is, the competence of the people on the other side of the table, which I didn't expect. Those are people from Medicare, basically, and under Oz's department. They were like talking to a business partner. They knew the stuff, they were very pragmatic, they could find solutions. Usually you expect from government negotiators to be the opposite of that. I think that was very surprising. Eventually, I think we did absolutely the right thing, and that was rewarded by the market and that, of course, 16 other companies followed, and now there are 17 companies. I think we put into rest two major uncertainties that existed at that time.
One was the tariffs that, based on the structure of how pharmaceutical has been organized the last 30 years, tariffs and imports could be catastrophic on patented products with high margins. The second was, of course, the fear for a drastic adjustment in the U.S. pricing across the board. I think those two went away. Now is the opportunity that remains, and the opportunity it is to see in the other rich nations to bring their prices to more reasonable levels. I'm not extremely optimistic that we will see that, but the first agreement that the U.S. government achieved with U.K., it's a significant advancement towards that, with the U.K. committing to go from 0.28% of GDP in innovative medicines to 0.6% within a decade, and 10% of that will be next year.
It's quite positive.
Actually, I was too quick to go to the macro. I think you wanted to make a few observations about Pfizer's business today to kind of set the stage for the rest of the discussion. Let me turn it to you.
Oh, thank you. I mean, I was very pleased with the year 2025. If you want to take, something out of it, what would be the conclusion? It is that Pfizer has proven that, is a company that knows how to execute. We were able, after the crisis that the company fell, after the COVID, drastic adjustments from $60 billion to $6 billion, we were able to retake out a lot of cost to reorganize our operations, to revitalize our R&D without affecting the top line. That, I think, was a significant achievement. Going forward, we announced four major priorities, and I will be very brief on them. The first one for this year it is to maximize the value of the recently acquired assets.
We acquired several things, but there are three that they account for 80% of the investment, which was an $80 billion investment that we have done in new, new businesses. This is Seagen, and this is Becerra, and this is Biohaven, so Nurtec. Those three account for 80%. They have both pipeline products like Becerra, they have mainly inline products like Nurtec, and they have a combination of both, which is the Seagen with Padcev and other products that are meteoric growing and with SV, PD-L1, et cetera, assets that are on the. The second is, you've noticed our fourth quarter call in end of January that it was focused zero on EPS. It was all Or revenues. It was all about the pipeline.
There's a reason for that, because this year is a pivotal year of R&D milestones. The second priority is to deliver on all of them. We spoke about regulatory approvals. Already we got two of the four that we are expecting. We spoke about to initiate 20 phase III studies, 10 of them in obesity. We spoke about eight significant readouts that will come there. All of that are important things that we want to deliver on. The third is to invest so that we can have industry-leading growth post our LOE period, so as we move towards the end of the decade.
That entails maintaining the dividend, we are very clear about it, but also investing in the business in addition to that, with R&D, building commercial infrastructures so that can maximize assets, et cetera, et cetera. I think those are the top three priorities that I would mention here. I'm very optimistic that the year will be a very good year for Pfizer.
Great. I'd like to drill specifically into point number two, that is the pipeline. As you said, Pfizer is looking to achieve industry-leading growth. What are the must win phase III product launches and or readouts to deliver on that?
Yeah. I will start with oncology because that's probably the crown jewel right now of the industry. I would say that important in the pipeline are SV, which is a Seagen compound that it is an ADC, but it is under two phase III studies right now. The first one is monotherapy, we'll read out this year in second line. The second one, it is combination therapy in first line together with Keytruda, we'll read out next year. It's very important that the two will fail, particularly in the phase that any other ADC failed in monotherapy. If we are successful on that, I think is a very big good news. We also have the CDK4 and the--
In general, the breast cancer front size, but they are progressing very rapidly and they are pivotal. Right now, they are doing the studies. I want also to emphasize that the Mirati portfolio, it is something that could help us significantly into that, given that we are aiming to launch them in year 2028. Given the successes and the how fast the market adoption of new products in that market surprised all of us. The ramp up of sales is different than anything else we have seen. Very quickly you are achieving very big sales. I think I'm also very optimistic on that. On vaccines, there are two vaccines that are very important. Actually three, because we have the Lyme disease that it is expected to read out this year.
If successful, will be the first and only Lyme disease, and that's a significant thing. We are already running a study for C. difficile, and that's a very important, let's say unmet medical need. Again, will be the first and only product for this disease. We are marching to maintain our leadership in the pneumococcal because we are bringing the 25-valent into pivotal studies right now. I will stop by saying that it's not only the pipeline, right? We have, through these acquisitions, in-line products that last year in 2025 they made $10 billion at a growth of 14%. This double-digit growth of this group of newly launched products, either through acquisitions or through internal pipeline, will continue growing the double digit this year.
By the year that we will reach the LOE, year 2028, which is an one-time event and then will go away, I think we'll find this with a sizable part of business that it is growing very high.
Okay. By the way, I should have mentioned at the outset, should you have a question and you're in the audience. J ust raise your hand and we'll call on you and get your question answered. Lots to dig into on specific products, Albert. Let's start with the pneumococcal vaccine. What's Pfizer's level of confidence that you will be the dominant player in 2030 as you are today?
I think, we will. The why I base that not only because I believe in our science and our products, but I know timelines. Right now, the biggest part of this, it is the pediatric. It is four doses for every newborn, compared to one dose for everyone who goes to 65 years old. That's a very, very big difference in the market with the same price, right? On that one, the timelines are telling me that from 2020 we'll go to 2025 will be the first ones, and with a significantly improved product compared to the 2020. I don't think anyone in pediatric is any close to us on that. The adult also, I'm very optimistic. This is where competition is.
We saw when competition came in the 2013, we were able to hold very lies our market share. Immediately with the 2020, we gained basically all our market. We have dominant market share in this market. I'm very confident.
Okay. Maybe we can move to obesity and at least for me, it's so easy to be schizophrenic on this market because on the one hand you see this big opportunity, but on the other hand you see pricing under pressure, compounding, lots of things to worry about, you know, limited growth in the market today. Why is Pfizer confident that by 2030 this is gonna be a great market for Pfizer to participate in?
Because the market in general will be very big, and we have been quite-- we are believers that this market will, is going to be very big. Not now, but we saw it from the old days because we tried with the obesity assets, which was the first oral PD-L1-- excuse me, GLP-1s that could come to the market. Unfortunately, science is not always what you hope, and we both of them fail. The reason why we thought that Pfizer needs to be in that market, it plays exactly in the characteristics of what makes successful a company in this market. It is the primary care, the consumer brand equity, how you can approach the consumer, direct sales. These are things that we have been extremely good at. The only analogy that I can bring up is the Viagra launch.
There is also Botox, which is similar to that. Although Botox is administered basically by not home, but by a physician. The Viagra was identical. At the end, over there, when we launched Viagra, we had all the issues that we see now with Novo Nordisk. The compounding, the counterfeits. We had a significant out-of-pocket cash market that people were willing to pay for the medicine, although it was very poorly or not at all reimbursed. We had that. What we didn't have was a portfolio because ours failed, the most advanced, and the others were very new. This is what Mounjaro did to us. I think the assets are highly differentiated. We have right now the results that we presented in for the monthly, for me was a huge relief.
Why I say it was a huge relief, because until that day, we knew with very high level of certainty that we have a weekly product. When we did the acquisition, we knew that. We also knew that the molecule had pharmacokinetics that is very likely to become a monthly product. I think what the study demonstrated is that we have a monthly product. Now let's discuss the profile. The most important is we have a monthly product that will be the only. Or not the only, because there is Amgen, but will be able to compete with the incumbents that they don't have a monthly product. I think the study as we was designed, was designed by Mounjaro to make sure that they maximize very quickly the knowledge so that they can advance to phase III. Probably would have done it the same way.
There were some characteristics in the way that they organized the studies. The study didn't have a lot of step-up dosing. It was in the max dose they reached after one or two step-up doses to reach the maximum. I remind you that Lilly's product, to reach the maximum, usually it is five, so it is the sixth time that you come. You push it a little bit. The second is that we didn't allow step downs in dosing. If someone had the vomiting, he had either to discontinue or to keep in the same dose and maybe vomit again. That of course is something that both of them will want to in the phase III.
It was important to do in the phase II because that gave us the valuable insights. What are these insights? That a monthly product that probably will be better than any other mono agonist and will be comparable with the current dual agonist in efficacy, and will have a profile on the safety that we hope will be even better, if not the same, and it will be monthly. That's a significant, let's say, competitive challenge to the incumbents.
Okay. That nicely explains the discontinuations you've seen, but the route around them and how you get to a better place in phase III.
Yes. Also I want to emphasize that in that study, they were test two doses, the low dose and the middle dose. In the phase III study, we are testing also, a higher dose, which is basically double than the middle dose, right? So it is 9.6 will be. I think that we have a very accurate modeling. It's a modeling, but it's proprietary. We developed when we were doing our danofloxacin and our oral GLP-1s. It has 60,000 patients database across the industry and a lot of very sophisticated mathematics that predicts based on several criteria what the efficacy would be. We predicted with a model the actual results of this study almost to the point, 9.9 compared to 10, for example, right?
12.2 compared to 12.3. That was the model projects that the 9.6 will be safe and more efficacious. A lot of excitement about what can come out of these studies.
Okay. This is not dissimilar from the first question I asked, where does Pfizer see it fitting in the obesity market? Where will you play or is it irrelevant because of the size of the market will allow you to be successful? Do you think you can get differentiation in one shape or form?
We have differentiation because, I mean, the first product is monthly. Actually, the second generation that is coming, which is the amylin and GLP-1, is also a monthly product. In our pipeline, what we are testing now in phase I, it is every three months product, which is quite promising as well. There will be differentiation. I think the amylin plus GLP-1 could surprise us in efficacy also. We wait to see, of course, the results. There will be differentiation. When we analyzed what happened in the marketplace, and right now, I think the big differences that we see are not only differences because of product profiles. It is big time, big differences in terms of go-to-market strategies that were different between the companies.
For us it's extremely important also that we will be in the forefront of testing the most aggressive forms of being able to maximize this portfolio. There will be a lot of segments in this portfolio. There are people that they want really to lose a lot of weight. They go for high efficacy. There are people that really want to have some casual weight loss, so they go for tolerability. There are people that they don't want the weekly injection, they want convenience.
The convenience could come either with oral solutions after they achieve their weight loss to go to oral solutions, which I don't think will be the segment, very much as a switch because once you are used to once a week, you don't want once a day, even if it is a pill. You would like once a month. There are many other things that I can explain why. There is also the way that people are going through the doctor or people are going direct and through e-commerce and all of that. Actually, I want to emphasize something that maybe-- I'm sure you have seen, but maybe some of the audience have seen.
We licensed GLP-1 in China. I'm not talking about the molecule, but it is a GLP-1 agonist in phase I, that it will go to phase II. I'm talking a product already approved for type 2 diabetes in China, and pretty soon we expect to be approved for chronic weight management. The reason why we did it, first of all, China is booming now, this market, so we wanted to be part of it. More importantly, we want to get significant insights in commercializing in different segments with an opportunity that we have right now in China. I think that will give us significant insights into our already very good capabilities in the space to be able to compete also commercially in a very aggressive way.
Questions from the audience?
I'll answer my own question.
You have the privilege.
Oh, I'm sorry.
There are some people who see the takeoff in the current oral therapies, and those curves and think, "Wow, in a couple of years, the oral therapies just taking the market and injections are gonna be left standing." That's one question. Second question is: How do the results of the recent head-to-head that Novo ran with tirzepatide, affect your thoughts on the capabilities of your dual?
Yeah. Excellent questions, both. I think the orals probably are gaining share in a new segment. This is the people that they're afraid of needles, so they don't want to go there, and people that they don't want to have very intense weight loss. They want to have more moderate weight loss because both products, I mean, will be one is registered, the other is not. They have lower efficacy than their injectable of the same company. I think that will be a different segment. The results of CagriSema compared to Lilly, clearly they failed to demonstrate non-inferiority. Of course, we take that into consideration. We are aware of where our studies are trending and we feel confident that we are different.
That's all I have to say right now. We have to wait because now we don't have a lot of data. We need to accumulate several months before we disclose the data of the combo.
I was going to ask--
By the way, it is combo monthly compared to weekly. CagriSema was weekly compared to weekly. Very different story.
I was going to ask whether you'll be doing head-to-head studies versus Lilly assets or Novo assets, but it almost sounds like the answer is you don't need to, right? Because you have a differentiated kind of strategy overall. Allow me to ask you the question. Will you do head-to-head studies?
Yeah. We are going to do 10 phase III only this year, and that's only-- not in the amylin and combo, but only in this monthly product, right? We haven't disclosed more than four of them, what will be, and I don't want to go into it. We did say, it's not exactly what you are asking, that we see a significant role for a monthly product in switch from any weekly product, not only for our own weekly product. That means that, because the product can go from weekly within few months to monthly, we can get, with this differentiation, a significant share, and that will be based in tolerability and convenience and in efficacy, which we need to compete all of that.
Also we can have people that already reached their plateau in weight and they want now to switch to something more convenient so that they can maintain their weight. That could be clearly something that we will explore.
Okay. At the risk of overstaying my welcome, I need to ask a question about tafamidis. I know the company doesn't like to kind of articulate the future beyond 2028, but it certainly seems that Pfizer has a strategy here. Of course, you always do. It's a strategy designed to get additional life out of this product. That's my assumption. The company hasn't said that, but would you urge me to rethink that statement?
No, I will stay out of this debate because it's very sensitive legal things that are complicated, and we are very good at doing these things. I mean, antitrust is our fault. I would say that our clear statement is by the end of 2028, the product will lose the patent, and we'll see how things go. I don't want to comment. That's my point.
Okay. Kind of going back to the big picture, is interacting with the FDA in the realm of vaccines, has it changed at all? You do have, as you mentioned earlier, quite a few vaccines. Have you had to change your strategy in dealing with the agency? Is Pfizer embracing one trial in to get a drug approved as opposed to the prior two trials for decades?
I must do a differentiation when we speak about FDA. There are the career scientists, the staff of FDA, those that they are there in the vaccines department, like in all other departments for many, many years. With them, we are having very productive professional collaborations. Most of them are renowned regulators, that when they publish something, regulators around the world, they listen to them. That hasn't changed anything in our discussions. We have a problem with the leadership of CBER. I think the current director is not following the recommendations of his staff, to say it very high. Forget if he's following the recommendations of our company, but of his staff, and that's a problem. We are dealing with that. If anything, that's in my mind an anomaly that will correct itself.
We are not going to go back to the period before Pasteur discovered the rabies vaccine, right? Vaccines will be extremely important. As a result, we keep investing in vaccines. Any changes are only tactical, what we are going to say or do in the next few years until the whole thing is predicted. On the FDA reform, on the one study, I'm very positive. I think that was a step that also the previous FDA should have taken. They didn't. This one they did. It is absolutely in the right direction, and I commend them for doing that.
Okay. When investors think about policy and/or regulation, they always think about it in a bad way. Can anything come out of all the changes that we're seeing that could actually benefit the industry and/or Pfizer? Maybe the one we just talked about was one example, one trial, but are there others?
I think yes. First of all, it was really understandable why investors focused on the negatives because the negative could be existential, could not be just a small problem. I think we were able to march through them, and I think now we have much more clear situation. There are some positives. Let me start with one positive that I don't think people notice that much. The PBM reform. There was a significant decisions on the way that PBMs operate, all within one, two weeks this beginning of this year. Those will have, I think, very positive results.
One was the law that President Trump signed that passed Congress, both Senate and House, on a bipartisan way that speaks about transparency and they need to disconnect their fees with the list price. Basically taking away most of the incentives that PBMs have to have a very high out-of-pocket and which is between the gap of the list and net price. There was a decision of the Department of Labor that instructs that they should provide transparency to all because that was for Medicare. The Department of Labor did it basically for commercial insurance by saying that they need to give to all sponsor of plans, of employers, full detail where the rebate went. Again, big incentive.
The third one, of course, was the FTC settlement of one of them that basically calls very clearly that the price that the patient should pay, it is the net price and not the list price. That's the commitment. Those by itself, I think, things that the industry is trying the last 10 years to change. By the way, I'm very happy and proud that just before I switched my chairmanship in PhRMA, we were able to achieve also that. That took tremendous amount of time of me and my peers in trying to explain to regulators and the administration the importance of that. We spoke about prices in international, that we could see a more positive environment going forward, particularly for the new products.
That I think is something that I truly believe, we have a good chance of it. I'm a very big supporter of this trade negotiations that the U.S. trade representative, Katherine Tai, is doing. I think he's the only U.S. trade representative that I worked with that really cares about the innovation, maintaining the innovation of the U.S. In the biosciences. He's really impressive how he navigate the challenges, but also more impressive how committed he is to make this happen. I hope we'll see good things coming out of it.
We are out of time, but I want to ask one last question, and that is, when you look at the next decade, what do you think the biggest change or surprise to investors will be at Pfizer?
Change or surprise, I think there are two things that are shaping the industry big time right now, One it is AI that is changing the landscape in ways that we have not seen before, and has the potential to completely transform not only the go-to-market, but to transform the way we do research, manufacturing, enabling functions, everything. The second is the meteoric ascent of a new scientific superpower, which is China. This is changing completely the calculus. It changes the calculus because these are people that they have ambitions. They are very good. They want to come and become global players, and to have seen their playbook in vehicles or in batteries, We know how that goes. They start, and then they go to conquer the market.
I think, for us, represents a challenge and an opportunity to be able to bring our productivity to their level. What characterize them, it is half the cost, three times the speed. That's what it is all about, and significant investments. What we need to do is to keep investing in research and innovation big time, then make our productivity double the cost and triple the speed, AI will be the biggest lever to do it.
I think either of those topics could have consumed a full hour, but, we do need to stop. Time is up. Thank you so much, Albert