In addition to the exceptional delivery from our internal pipeline, we’ve also been directive with business development, building capabilities and adding new platforms to strengthen our R&D efforts in key areas, which we believe have the potential to radically improve patient outcomes, including radio conjugates, gene therapies and cell therapies. We’re very much looking forward to sharing more details about our pipeline and the long-term outlook for our company at our upcoming Investor Day on the 21st of May. Please advance to the next slide and we will go to the Q&A. As Andy mentioned at the start of the call, please limit the number of questions you ask to allow all a fair chance to participate. For those on line, please use the raise your hand function on Zoom.
And with that, let’s move to the first question, which is from James Gordon of JPM. Over to you, James.
Q – James Gordon: Hello. James Gordon, JPMorgan. Thanks for taking the questions. First question is on ’24 guidance. So it’s a very strong revenue growth, 19%. In order not to grow revenues at teens for the year, it looks like you need to only grow at about 10% for the rest of the year. So in terms of headwinds, we should be mindful of that would drive nine percentage points of deceleration. And I heard a comment on maybe for Farxiga VBP and Imfinzi price in Japan, but anything else and in particular, for Farxiga, Symbicort and Tagrisso that were very strong this quarter? Are there things through the year that we need to watch out for? Or does that look quite sustainable? And also on ’24 guidance, just on OpEx, the ratio is a little bit good to say, but this is with the strong top line before the two deals close.
So if revenue growth is a little slower through the year and you consolidate these deals, do we need to be careful on those ratios? Or can you still keep a pretty high margin? And if I could squeeze in a quick second question, just [indiscernible] and the Oral GLP-1. So I believe you’ve expanded the trial and maybe taking dosing higher. So on that, what is the latest thinking in terms of where we might see the data? I didn’t see a reference to ADA. And how are you now thinking about how competitive this product might look in terms of the weight loss and other aspects versus some other recent readouts from competitors?
Pascal Soriot: Thank you, James. James, sorry. Aradhana, maybe you can take the first one. And Sharon, would you take the second one?
Aradhana Sarin: Great. Thank you, James, for the question. It is obviously early in the year. And as you know, generally, we don’t update or provide more color on the guidance in first quarter. You’ve seen from the reported results, the underlying trend in our revenue product sales is very, very strong across the board. You’ve also mentioned some of the uncertainties that Ruud also mentioned as well as Dave. So those uncertainties are there for the remainder of the year. However, if our momentum continues the way it has been in the first quarter and some of these uncertainties on VBP pricing, et cetera are in our favor, you can think about our product revenues, our product sales and Alliance revenues could be at the upper end of our range or higher.
So — but again, we’re not updating our guidance at this point. We will continue to invest in our R&D for the long-term, including the acquired product and continue to invest in SG&A to drive the top line momentum that you’ve seen. Operating leverage continues to be a focus for us. Again, you’ve seen this quarter as well, 19% revenue growth and 13% SG&A growth. And we will try to maintain stronger revenue growth than expense growth in the coming quarters as well. With that, maybe Sharon?
Sharon Barr: Sure. So thank you for the question about AZD5004 oral GLP-1 receptor agonist. We’re really excited about this molecule and its potential to treat the interrelatedness of cardiometabolic and cardio renal disease. You asked specifically about the Phase 1 study. And as I’m sure you’re aware, we completed, together with Ecogene, a highly controlled inpatient Phase 1 earlier this year. We have the data in hand and look forward to presenting that at an upcoming medical conference later this year. You also asked about how we view the competitive position of this molecule. And recognizing that it is a highly competitive field, we do feel very optimistic about the potential for this molecule as a stand-alone as well as in combination.
So when we think about how we’re treating obesity and metabolic health, I think we honestly do ourselves a disservice by referring to this as obesity. What I’d like us to do is think about this more clearly is treating the interconnectedness of disease. And to that end, we are uniquely well positioned to combine this orally available molecule with other molecules in our portfolio that help address those interrelated diseases. As an example, combining 5004 with our SGLT2 inhibitor. So when we think about this, we can imagine that at a fixed dose, we may want one dose that would be compatible for fixed-dose combinations and another dose that would be more compatible for additional weight loss in obesity indications. And we’ll keep that in mind as we continue to design our clinical development program.
Moving forward, we have publicly stated that we will be launching two Phase 2b studies later this year, one in obesity and one in Type 2 diabetes.
Pascal Soriot: Thank you, Sharon. And James, you asked the question of the doors, but you got to remember that not everybody needs to lose the same amount of weight. And so as you target higher weight losses, Sharon was talking about in the Obesity segment, you would expect to have to go through a titration regimen and get to a higher dose. So it’s not surprising that we would explore different doses depending on how much weight loss patients are needing. The next question is Seamus Fernandez of Guggenheim. Over to you, Seamus.
Seamus Fernandez: Great. Thanks for the questions. So I guess as, Pascal, a little bit of a preview of the upcoming analyst event. Just hoping that you could provide us with a little bit of color on how you’re thinking about potential for updated guidance. Is the most important factor of the meeting really giving and helping us understand long-term visibility around revenue? Or is it more on a margin or a little bit of both? And then just a second question. As we think about the three products that you’ve highlighted on the BioPharma side of the business, the oral PCSK9, the GLP-1 and the long-acting amylin, just hoping you could help us or help provide some context around of the three which you’re most excited about and perhaps when we might see data on all three? Thanks.
Pascal Soriot: Thanks, Seamus. So the first question about the Investor Day, I guess I would like to invite you to join us in a beautiful Cambridge to see more of the details of what we’re going to present. But the short answer to your question is a little bit of both. Essentially, what we want to do is show people how we are looking at what I call today, tomorrow and the day after. Today is what do we intend to deliver in terms of our financial progression in ’24, ’25, ’26. Tomorrow is what are the products we are going to launch that will drive our growth between 2025 and 2030, and what is our strategy there, what do we intend to do with our pipeline, and what other products we believe are growth drivers to 2030. And the day after tomorrow is really the sort of post-2030 period.
And what are — what do we believe are the technologies that will shape the future of medicine in oncology and beyond, and how are we building some of those platforms that will help us shape — participate in shaping the future of medicine in the therapy areas where we are. So that’s really what we want to do at the Investor Day. And we also offer, for those of you who are early risers and will be physically on site, we’ll also give you a chance to look around our site and experience a little bit what we have on site. The second question, let me give you a couple of comments and then maybe Ruud and Sharon could add. We are always more excited about products for which we have more advanced data. Those three products are, of course, exciting, but we have more data for the PCSK9, which is a very exciting product.
And also more data for the oral GLP-1. Long-acting amylin is technically interesting where we need more data, but it certainly so far looks pretty good. And we think we can actually, as Sharon said, with the combination of the GLP-1 and the rest of our pipeline, not only PCSK9, but also dapa and also potentially Baxdrostat, we can make a difference in this segment of patients who need to lose weight but also manage their cardiovascular risk factors. And in the obese segment, where people need to lose 20%, 25% of their weight, then we can look at combining our overall GLP-1 with the long-acting amylin and some other mechanisms. Sharon, if you want to maybe also add a little bit on how you see this pipeline.
Sharon Barr: Sure. So I’ll jump in on both. People often ask about which molecule I’m more excited about. And I find that very difficult to answer because, obviously, I’m very invested in all of them. But the first one that you asked about was our oral PCSK9 inhibitor, and we are extremely excited about the potential for this molecule. We will be releasing Phase 1 data at an upcoming conference in the very near future. But I think it’s safe to say that we set ourselves a very high bar with this molecule, but we asked that it be able to meet a major unmet medical need. We know that despite high-intensity statins, about half the patients with cardiovascular disease are not hitting their LDL targets. And so we asked this molecule to be able to offer substantial lowering on top of statins, and we’re very encouraged by the data that we see.
So we are actively moving forward with this molecule in clinical development and thrilled to be sharing the data at an upcoming conference. Relatedly, you asked about our obesity portfolio. And again, I think I would really think of it more as our optimal weight management portfolio, in which we are exploring both incretin and non-incretin pathways as multiple mechanisms to manage both weight and interrelated cardiometabolic and cardiorenal disease. So we are positioned to go beyond short-term weight loss and to deliver long-term weight management and healthy lean mass management, addressing cardiometabolic risk and also organ protection. And we think that we’ll be able to achieve this by driving forward with multiple mechanisms in combination.
Thinking about both the incretin pathways, as we’ve discussed earlier with 5004, and non-incretin pathways, for example with long-acting Amylin. Long-acting amylin, as you can imagine is a different route of administration and we think could offer some additive benefits outside of that, that we’re already seeing in the incretin pathway. So we are accelerating several assets through Phase 1. We spoke earlier about 5004, AZD6234 is our long-acting amylin, ACD9550 is our GLP-1 glucagon dual receptor agonist. And both of those added two molecules are progressing through Phase 1. We look forward to sharing it with you when ready.
Pascal Soriot: Thanks, Sharon. Ruud, anything you want to add?
Ruud Dobber: No.
Pascal Soriot: Cool. So let’s move to the next question, Sachin Jain at Bank of America. Sachin, over to you.
Sachin Jain: Hi, there. Thanks for taking my questions. Sachin Jain, Bank of America. First one today on Truqap. Strong first quarter, just any initial launch feedback. And then I’m going to try and go to Roche talked to $2 billion for their PI3K yesterday. I wonder if you could talk about the relative profile of your asset related to this and whether you’d go bigger then $2 billion in breast and size, the prostate opportunity that Pascal specifically called out? Second question is for Susan. AVANZAR is due in ’25. When do we see the data that informs on your confidence? And what I’m after there is timing of any TROP2 biomarker data? And what should we focus on from TLO2 at ASCO? But I think, you’ve commented to. And then last quick question for Sharon, [indiscernible] now 25 plus. Do you still plan an interim next year? Thank you.
Pascal Soriot: Dave, do you want to start?
David Fredrickson: Sure. Thanks, Sachin for the questions. So on Truqap, we are really pleased with the launch and following what was a really positive reception to the presentation of the data we’ve seen that the uptake is really moving quite nicely. And I think that uptake in the biomarker population really speaks to the need to extend endocrine-based therapies. We see testing rates are well established by NGS in the U.S. So we’ve got over 60% on that. And while there was a previous standard of care with PI3K, we’re seeing that rapidly get displaced, there is still plenty of opportunity to continue to grow within that segment. So demand is off to a very good start, though I think that there is certainly much more opportunity for us to continue to grow.
There’s some late line bolus that we’re probably seeing within the numbers as well. But again, I think that underlying demand and the indication that we’ve got is very, very strong. On your specific question also around comparison to the INAVO120 data, from my and our understanding, I think that you first have to take a look at the inclusion criteria. The inclusion criteria are certainly different between that study and 291. In that study, the inclusion criteria only include patients who have progressed during or within 12 months of adjuvant ET completion. It’s also limited to the PIK3CA patient population. So if you take a look at 291 within that context, we really have the de novo and the nonearly relapsers in the second line post CDK4/6 plus AI setting in addition to the fast progressors.
And I see more like three quarters of the patients falling into this de novo nonearly relapser population. So I’m enthusiastic about the opportunity in breast cancer. I’m enthusiastic about the opportunity also in prostate cancer. And I think you put these two together, and we’ve got the potential for Truqap to be a multi blockbuster.
Pascal Soriot: Susan?
Susan Galbraith: Okay. Thanks, Dave. So for AVANZAR, again, yes, as I said, the trial is going well. But the TROP2 biomarker data, I expect that we would be able to share those data at the Congress within the next 12 months certainly. And as far as ASCO goes, one thing beyond the lung cancer data that I would encourage you to take a look at is the I-SPY 2 data, which is a neoadjuvant study in breast cancer. Again, looking at the combination of dapa and Imfinzi in that setting. So I think we continue to be happy with the profile that we’re seeing for data plus IO across the first-line settings in lung cancer. The safety is looking very reasonable because we’ve got many patients now enrolled into those first-line settings. And again, as we move this combination into the earlier lines in settings like the neoadjuvant setting, I think both the safety and the efficacy profile look encouraging. So that’s what I would point you to ASCO. Thanks.
Pascal Soriot: Thanks, Susan.
Sharon Barr: And then your last question, I believe, was about the Eplontersen CARDIO-TTRansform trial and our expected time line for readout on that one. So as I mentioned earlier today, we remain extremely optimistic and excited about the potential for this molecule. And I showed you some early data that came from our NEURO-TTRansform study, which demonstrated a benefit on cardiac structure and function, which gives us additional confidence in the potential for the molecule as we walk through the CARDIO-TTRansform study. This molecule has the potential to be a best-in-class and transform care for patients with amyloidosis. So to that end, we would like to give this trial the best chance for success and to be able to read the full trial data at the 140-week time point. That in mind, we’ll continue to scan the competitive landscape and make the appropriate decisions as we move forward.
Pascal Soriot: Thank you, Sharon. And Sachin on part of your question, we never comment, as you know, on interim analysis. So of course, we will not do any — we will not do it here either. Next question is Tim Anderson at Wolfe. Tim, over to you.
TimAnderson: Thanks. Hopeful of questions. On data, just an update on your thinking on the lung filing in the U.S., if the overall survival data only continues to be directionally supportive and doesn’t fall a little bit upper-end threshold of one. Is that enough to get U.S. approval? And then what would that mean for ex-U.S. approval? And when is that next survival look going to incur? And then the second question is just emerging markets. China, obviously has slowed from years ago for lots of companies. What really stands out in your results is that non-China emerging market segment, which is substantial now continuing to grow. But it’s just not clear to me what the drivers of that are in terms of geographies and products, and therefore, what the future growth expectations should be in those non-China markets. So if you could add some commentary, that would be helpful. Thank you.
Pascal Soriot: Thank you. So maybe, Susan, you could take the first one.
Susan Galbraith: Yes. So for Dato-DXd TROPION-Lung01 study, obviously, we’ve announced that we have filed, obviously, for all regulatory authorities OS in lung cancer is an important component that they want to look at. We said that the timing of the OS data cut is around the middle of the year. As you know already that we saw an overall trend in favor of OS on the data arm in the ITT, but what we also saw is in the non-squamous group a more positive trend with the upper end of the confidence [ph] interval just crossing one. So we were looking and hoping that we’ll see both of those continue or improve. And I think that will be an important piece for the regulatory authorities to look at. Thank you.
Pascal Soriot: Thank, Susan. And the second one, maybe Leon, who is online, I believe, Leon, can you actually comment on that one?
