Leon Wang: Yes. I think, Tim, actually, across the all geographic AstraZeneca emerging market has been growing rapidly and almost no exception. And of course, there is some currency depreciation in certain countries. But overall, still very, very strong growth. And we are also in line with the global new product launch. I think Tagrisso, Farxiga, these oncology brands, and also rare disease as a new growth driver, and is also doing very well across the emerging markets. And all in all, on top of that, the LOE post patent expired products, the legacy products, that are still quite that we spend very little resource and also growing nicely to support as a cash cow, our new launches. And also across the region, we are speeding up approval in many emerging markets. So we launched new products much earlier than before.
Pascal Soriot: Thanks, Leon. So net-net, Tim, you have really two factors. One is we have a very strong commercial footprint in those countries. Now we are actually the number one pharma company in the international region. And so we are leveraging this strong commercial footprint across all subregions. The second factor is we actually, a couple of years ago, invested more resources into a specific international region, regulatory team. And that team has been fast tracking, filing and approvals of new products in those countries who historically were falling behind the priority geographies. And now we still launch after the U.S. and Europe or Japan in those countries, but not that much later, and we are still working on accelerating this. So those two factors are really the most important growth drivers. The next question, I think, is Mattias Häggblom at Handelsbanken. Mathias, over to you.
Mattias Häggblom: Thank you. It is Mattias Häggblom, Handelsbank. Two questions, please. So firstly, on Dato-DXd, you initiated a couple of additional Phase 3 programs during the quarter with your partner. So what makes you so confident to continue to invest into these programs? Or asked perhaps differently, with investor communities still skeptical today to the — what in particular is it you see that investors may miss? And then secondly, as one of few companies with both bispecific antibody as well as cell therapy capabilities in-house. Can you talk about how you think about engaging these tools into autoimmune disease, whether it’s emerging early data from both sets of technologies that looks promising? Thanks so much.
Pascal Soriot: Thanks, Mattias. So first question, I think we’d go to Susan. And the second, Sharon, you’ll take that one. Okay.
Susan Galbraith: Yes. So thanks for asking the question about Dato-DXd. So yes, we have announced that we’ve — we’re starting TROPION-Lung01, which is a combination with rilvegostomig, our PD-1/TIGIT bispecific and data, compared to pembro in locally advanced first-line non-small cell lung cancer. And again, that is a program where we’re going to be looking at this activity in a biomarker selected group as well. But it also includes the ability to compare rilvegostomig directly with pembro in that setting. So I think what underpins our confidence there is both the combinability and with IO that we have seen in different settings, the potential for the — some added efficacy for the addition of the TIGIT mechanism of action as part of this bispecific within the PD-L1 greater than 50% patient population as well.
And we think that this can be a winning combination in that setting. The other important study that I draw your attention to is the TROPION-Lung14 study, this is a combination of Dato-DXd and Tagrisso in the first-line non-squamous EGFR-mutant non-small cell lung cancer. And again, this builds on both safety and efficacy data that we’ve seen from the ORCHARD platform study that we have in a post generation EGFR inhibitor patient population in the EGFR-mutant. And also the safety and combinability for that combination. So that’s what gives us confidence. As you may have seen in the TROPION-Lung05 data that was published is actually really good activity for Dato-DXd within the EGFR-mutant population. And given the FLAURA2 data, which we’ve also seen I think that that also builds confidence in the ability to combine Tagrisso with chemotherapy and directed agents.
And so I think this has the opportunity to further build on the data that we had from FLAURA2 and the data from ORCHARD and really have a winning combination in the first-line setting for EGFR-mutant non-small cell lung cancer.
Pascal Soriot: Thank you, Susan. Sharon?
Sharon Barr: Sure. So thank you very much for the question about cell therapy and bispecifics in autoimmune disease, because I think it’s a really interesting topic that has become a key focus for us. As we think about how we manage diseases of immune dysregulation, we are moving from managing symptoms to modifying disease by adding the causality of disease. And the mechanisms that you mentioned, cell therapy and bispecific molecules, are two excellent modalities that allow us to really address the causality of disease. So to that end, we have invested in internal capabilities, but also accelerated our ambition with recent acquisitions. As you saw, we very recently closed an acquisition of Gracell which brought to us some, I think, leading capabilities that allow us to really accelerate our ambitions in cell therapy for patients with autoimmune disease.
And specifically, gray cell has a bi CAR-T which they have used to complete an investigator-initiated trial in China for patients with systemic lupus erythematosus, or SLE. And we look forward to share those data at an upcoming medical conference. But I think it’s safe to say that the data that we have seen across the patients treated is at least as compelling as anything that we in the published literature and gives us a lot of excitement and optimism about how we may be able to address SLE for patients moving forward. At the same time, we’re also investing in our internal platforms for creating T-cell engagers, which we think also could be a very powerful modality in the autoimmune space.
Pascal Soriot: Thank you, Sharon. Mark Purcell at Morgan Stanley. Mark, over to you.
Mark Purcell: Yes, thank you very much, Pascal. Two questions. The first one, the U.S. oral oncology products, the product sales there were very strong in the quarter. Could you help us understand the impact of treatment initiation dynamics and potential changes in affordability? And then secondly, on the Fusion Pharmaceuticals platform, for FPI-2265, can you help us understand your plans for moving into sort of pre-taxane setting? Would you do a head-to-head trial there versus Pluvicto potentially combined with PARP-1? Obviously, understanding with the post-Pluvicto opportunity itself has blockbuster potential anyway. Thank you very much.
David Fredrickson: So Mark, thanks. I’ll take the first question, probably Susan on the second. I mean I think the first important piece is that within the quarter on our oral oncolytics, particularly with Calquence and Tagrisso, we saw a strong market share performance. Calquence remaining the leading BTKi in front line CLL, and strong continued demand growth for Tagrisso in adjuvant in front line and encouraging early FLAURA2 launch. With that said, also, we do see early encouraging trends of lower abandonment and improved access due to affordability, though it really is too early to quantify. And of course, recall, Mark, that in 2024, there’s no added liability associated with Part B, whereas it comes in ’25. But we’ll continue to keep updated on how those dynamics on affordability evolve over the course of the year.
Pascal Soriot: And Mark, on your second question, the deal hasn’t closed and so we are not able to comment at this point in time. Sorry about this, and hopefully, we can give you an answer pretty soon. Richard Parkes at Exane. Richard, over to you.
Richard Parkes: Hi, thanks for taking my questions. Firstly, sometimes when speaking to investors, I get the perception, those are feeling that AstraZeneca is spreading it cells too thinly with expansion into vaccine cell therapy, radioligand. Just wondering how you respond to that and whether you see any risk of the organization losing focus, and how you’re thinking about some of those investments in new platforms? It feels to me like there’s more you’re just thinking about that the day after tomorrow. So that would be very helpful. And then on Airsupra, could you just talk a little bit more about the opportunity you’re seeing? Obviously, we’re seeing some very large drugs in that category in the past. And just thinking about how you’re thinking has evolved on the opportunity since the launch. Thank you.
Pascal Soriot: Thanks, Richard. Let me try the first question. And maybe Ruud, you could cover the second one. So the first question, I think first point is, I’m sure you’ve realized, we have a very, very strong team and people are very focused on oncology, BioPharma, rare disease and managing their portfolios. Second point is we are now kind of a $50 billion company. So you really need a portfolio to continue growing. And I think this is one of our strengths. We’re not depending on two or three products. We have a portfolio of products that are driving our growth. And we can actually highlight that better to you at the Investor Day very soon. Third point I would make is that actually, this portfolio actually gives us the opportunity to combine.
And again, that’s what we want to highlight during the Investor Day. We’re in a unique position to combine in oncology across ADC, bispecific, potentially in bispecific IO potentially in the long run, take an approach to solid tumors to address the tumor with a combination of ADCs and bispecific and follow this with TCEs or cell therapy. In the cardiovascular space, Sharon has covered it, we can combined across the GLP-1 and PCSK9 or the other agents, the PARP, of course. So I think these are the things that actually help us. On the vaccine front, I think there’s sometimes a misperception of what we’re trying to do. We’re not trying to build a vaccine business like vaccine companies have. We are actually targeting vaccines that will be synergistic, strategic to our vaccine and antibodies, by the way, that are synergistic to oncology or respiratory disease products that will protect patients from exacerbations of COPD or asthma products that would protect patients from COVID or flu infections.
If there are say cancer patients, blood cancers in particular. So this is really what we’re trying to do, always try to be implementing a sort of a strategic synergy across our portfolio and leverage our expertise and [indiscernible] in various places. So I don’t think we are too thin. And then too thin spread. The challenge and the opportunity in our industry is always to be able to think about today, but also the long term. It would be very easy, quite frankly, or easier to focus on the next four, five years. But we also have to think about what is going to shape the medicine in five to 10 years. So that this company remains a growth organization, not only in the next few years, but in the long run. And so that’s always the challenge is really to manage our near-term long-term, but also it’s an opportunity.
If we do that well and if we play our hands very well, we can be very differentiated as a company. So Ruud, over to you.
Ruud Dobber: Yes, of course. And thank you so much for the question, Richard. So first of all, Airsupra is a unique product in the United States, because it’s the first rescue therapy for asthma patients above 18 years of age. It’s a very substantial market. The short-acting beta agonist market. Just to give you a little bit of context, roughly 35 million inhalers are prescribed every year for the 18-plus population in the United States. So the volumes are very, very substantial. And we truly believe with that, we have a product in place which can change the treatment paradigm of as needed as rescue medication in the U.S. Of course, it’s still early days, but the fact that we already see a very substantial number of scripts every week, plus that more and more physicians are prescribing it.
I truly believe that over the next few years that this product will become a blockbuster molecule. And equally, we’re also looking for other opportunities in other geographies in the world. Especially in the Middle East, we see good opportunities to launch the product there as well in the next few months. So all in all, very bullish regarding the forecast and the potential of this product moving forward.
Pascal Soriot: Thanks, Ruud. The next question is from Christopher Uhde at SEB. Christopher, over to you.
Christopher Uhde: Hi, can you hear me?
Pascal Soriot: Yes.
Christopher Uhde: Good. So yes, I guess, first question is a lot of the key sort of Part D products, and I guess the U.S. in general had really strong performance. Can you quantify how big a headwind the typical U.S. coverage resets amounted to? And what factors beyond strong demand, help explain why Q1 was so strong? And roughly, how much did they selectively contribute then to top line growth? Noting that, for example, Farxiga was one of those factors was the authorized generic. And then my second question, which pipeline events for the rest of 2024 do you get most excited about? And which do you think the street might be underappreciating and what are we missing if so? And if I could sneak in the last one. You said M&A will slow down earlier today I’ve read. As you’ve got most of what you need. I know you don’t have a KRAS though, perhaps you could tell us what your thoughts are around KRAS and why that isn’t in your portfolio? Thank you.
Pascal Soriot: Thanks, Christopher. So maybe, Ruud, you could take the first one, and I’ll try to address the others.
Ruud Dobber: Yes. Yes, an excellent question. We have seen very strong growth in the United States for both Farxiga and Symbicort. It’s driven by two different factors. First of all, we have launched an authorized generic of Farxiga in the United States. The option for patients to have a lower cost option as well. And so far, we are very pleased with that introduction of this new — not new medicine, but this new offer to patients. And of course, we will not know until, let’s say, a few quarters more how the products will be perform. But so far, the feedback has been extremely strong. Equally, I think it’s important that looking at Farxiga in totality, that the growth across the world is extremely strong on the basis of the CKD and heart failure indications.
And there’s no reason to believe that that will slow down anytime soon. So that’s good news. Symbicort, we have closed our list price, the so-called reg price in the United States, like other competitors have done as well. So we need to see how that will evolve in the next few quarters. So it’s a little bit of a new dynamic in Part D, let’s say, in quarter one for our products. But all in all, a very nice first few months, and we will monitor it very closely, of course, moving forward.
Pascal Soriot: Thanks, Ruud. I mean, try the — other two questions quickly in the interest of time, is the pipeline and what is more exciting until 2030, Christopher, I would again invite you to join us in Cambridge. We are offering free tickets, a visit to beautiful Cambridge. And I’m sure we’ll find a way to give you a nice lunch, too. On the M&A, I said it will slow down. It doesn’t mean it will be zero. What I meant to say earlier in terms of slowing down is from a technology, from a platform viewpoint, I think we have acquired and built most of what we need for now and we need to execute on what we’ve got. But it doesn’t mean, of course, BD will come down to zero. And in terms of the specific last question, I want to answer this one. But we have our own internal program, and we can discuss some of those things again in Cambridge. So I’ll move to Eric Le Berrigaud at Stifel. Over to you, Eric.
Eric Le Berrigaud: Thank you, Pascal. First question to come back on Farxiga and Symbicort in the U.S. Maybe more specifically on Farxiga, is there any way we can get any idea about the one-off could be into the Q1 numbers with the inventory buildup for the authorized generic. And on Symbicort, in the context of the drug being genericized in the U.S., we’re expecting sales to go down. It was up 28% in Q1. What could be the dynamic for U.S. Symbicort for the full-year ’24? And then a more general question. We see more and more companies simplifying, streamlining the organization by combining the different divisions in one single like vaccine with pharma or onco with the rest of pharma. And you’re still operating with different entities like onco, BioPharma, Alexion, D&I. Could you maybe summarize maybe you’re thinking about doing things differently, but the benefit of doing the way you do and benefit versus risk and complexity? Thank you.
Pascal Soriot: Yes. So let me start with this question, and Ruud can cover Farxiga and Symbicort in the U.S. It’s not still, it’s actually we moved to that structure not that long ago, a few years, of course. But in our industry two, three years is not a long or four years is not a long time. That’s what we believe and in the importance of being focused, on the one hand, people say you have too much; on the other hand, we say, well, put everything together. So I think the reason why we can succeed with our portfolio and leverage that portfolio is because, indeed, we are focused. We’re focused on oncology, biopharm and rare disease. And anybody who’s operated in oncology I think would, hopefully agree with me that oncology is very specific.
This is very specific and just the same as cardiovascular, you need to build capabilities. And you can do this if you do two things. First of all, recruit the right talent to understand the environment they are in. And secondly, create a culture and in a community where people feel they work together to the same goal. In the case of cancer, the goal is eliminate cancer as a cause of death. And every immunity in the company has this total focus, that share purpose, and that’s what drives people. People come to work to make a difference and make a difference in the field they are in and the field they love typically. So I think this is really the reason why we can actually succeed, and we’ll intend to keep that structure as it is. Ruud, over to you.
Ruud Dobber: Yes. Thank you, once again, Eric, for the two questions. First of all, once again, let me remind you about the U.S. is a very important market for Farxiga, there’s no doubt, but it only represents less than 25% of our global sales. And we are very pleased to see that’s the brand is growing extremely fast, not only in the United States but across all the other geographies. Specifically to your question, can you provide a split between the authorized generic and the brands, the short answer is we’re not going to do that. But equally, of course, you can look at the script volume, if you analyze the script volume of Farxiga, is the Farxiga brand as well as the authorized generic. Now whether the strong initial growth will continue moving forward.
