Welcome to the second day at the J.P. Morgan Healthcare Conference. I'm Richard Vosser, European Pharma Analyst with J.P. Morgan. It's my great pleasure to introduce AstraZeneca for you today. From AstraZeneca, we have Aradhana Sarin - sorry, Aradhana - I'll get there in the end, who's the CFO of AstraZeneca. And we also have Dave Fredrickson, EVP of Oncology, who's going to be here for the Q&A. Just before I hand over to Aradhana, just a few housekeeping issues. If you put up your hand, we'll take questions from the room, or you can also email them in through the portal. Aradhana, welcome to the conference.
Great. Thank you so much, Richard, and welcome, everyone. My name is Aradhana Sarin, and I'm proud to represent AstraZeneca this morning to share our remarkable progress in 2025 and expectations that we have of the sustained momentum in 2026. This is our forward-looking statement, which I encourage all of you to review. We saw very strong commercial performance over the first nine months of 2025. Total revenue was up 11%, and core EPS grew 15%. Our pipeline delivery was unprecedented. We had 16 positive Phase 3 readouts since our fiscal 2024 results, spanning the breadth of all our key therapy areas. Our strong growth was driven both by our global reach and diverse sources of business. Key strengths for AstraZeneca: Oncology grew 16%, reflecting the ongoing demand for a broad portfolio of medicines.
Biopharmaceuticals and rare diseases were up 8% and 6%, respectively, with the growth of our newer medicines more than offsetting the impact from loss of exclusivity of a limited number of mature brands, including Brilinta, Pulmicort, and Soliris. We saw impressive performances across all regions, notably in the U.S. with 11% growth and emerging markets outside of China growing 21%. The underlying growth momentum in the first nine months of 2025 allowed us to reiterate our four-year guidance with total revenue and core EPS to increase by high single digits and low double-digit %, respectively, at constant exchange rates. We do anticipate fourth-quarter headwinds related to VBP and year-end hospital order dynamics in China, as well as tender offer timings in certain emerging markets, as previously communicated.
Also, as a reminder, we booked more than $800 million in sales-based milestones under collaboration revenue in the fourth quarter of 2024, which will affect year-over-year comparison. We will report our full-year results on February 10th and welcome all of you to listen in. The significant progress we've made this year has further strengthened our confidence in reaching our $80 billion ambition in 2030, which we first set out in May of 2024. We have continued to see our commercial portfolio deliver and look forward to launching a number of new medicines in 2026, including baxdrostat, camizestrant and garadacimab, all of which are under regulatory review, and looking beyond 2030, we are investing behind transformative technologies that have the potential to change the practice of medicine. 2025 was a catalyst-rich year with readouts collectively representing peak revenue opportunities of over $10 billion.
Toward the end of 2025, we were delighted to receive FDA approvals for Imfinzi in perioperative gastric cancer and Enhertu in first-line HER2-positive breast cancer, further strengthening the global outlook for these medicines. In addition, the FDA accepted baxdrostat for priority review in hypertension. A deep and rich pipeline reflects years of robust and disciplined governance over R&D investment and portfolio prioritization. We consistently generate more high-quality ideas than we can fund. Each year, our world-class teams of clinical and commercial leaders conduct a comprehensive strategic planning exercise, which assesses the broadest opportunity for sustaining leadership within our core therapy areas. These opportunities are then optimized during our mid- and long-term budget planning cycles to align with our enterprise aspirations.
And ultimately, each project is signed off through project-specific investment decision, ensuring rigorous scrutiny and challenge so that every investment is commercially viable and designed with the ambition of truly advancing clinical practice. R&D budget is not pre-allocated by therapy area. Rather, all projects are ranked collectively using a rigorous decision-making model, enabling us to take targeted, science-driven, smart risks. This disciplined approach supports our late-stage success rate and allows us to optimize investment decisions across therapy areas, balancing near-term launches with platform opportunities and with the potential to compound over time. As previously communicated, we anticipate full-year 2026 R&D costs to land towards the upper end of the low 20s % range of total revenue. This level of spend will allow us to invest in emerging opportunities while at the same time deliver 104 phase 3 studies that we have ongoing.
Our late-stage portfolio continues to grow and broaden, and the value associated with these trials is not only increasing as a whole, but also at an individual asset level. As you can see on the left-hand side of the slide, the number of unique assets in our late-stage pipeline has grown over the years. In parallel, the average non-risk-adjusted peak year revenue potential per indication has also increased, now approaching about $1.3 billion. The composition of our pipeline is also evolving as we continue to invest behind our transformative technologies, including novel ADCs, radioconjugates, and cell-based therapies. At the same time, patient enrollment in our trials is increasing, with a large step-up anticipated in 2026, driven by increased investments in our CVRM pipeline, where we are running several large outcome studies.
AI is transforming our ways of working and is already embedded in end-to-end across AstraZeneca, from discovery to development to commercial to operations through healthcare delivery. AI is helping us drive outcomes, boost efficiency and productivity, and accelerate innovation with measurable impact. To highlight a few examples, first, IDA, our agentic system for synthetic drug process development, integrates simulations and internal expertise. In CMC, this approach has the potential to decrease time-to-commercial scale-up for synthetic manufacturing by up to 50%. Secondly, in clinical development, our proprietary AI-enabled solution, QCS, or Quantitative Continuous Scoring, applies computational pathology to help identify patients most likely to respond to treatment. We are actively applying this technology across our ADC pipeline. And just this morning, we announced the acquisition of Modela AI, which has the potential to further our pathology foundation models, enabling further development of targeted therapeutics along with diagnostics in our oncology portfolio.
Over the course of 2025, we have made substantial progress over transformative technologies, accelerating multiple programs into late-stage development to support our growth into the next decade. Over the next few slides, I will dive deeper into some of the recent advances across these pillars. Cardiometabolic disease remains a major global burden, and to address this need, we are developing multiple pipeline assets. AZD0780, our oral PCSK9 inhibitor for dyslipidemia, is a true small molecule with no food effect or fasting requirement. In the Phase 2b trial, we were excited to achieve greater than 50% LDL-C reduction on top of standard-of-care statins, and we anticipate the first pivotal phase 3 readout from the AZURE- LDL and the AZURE- HeFH trials in 2027.
In weight management, we're advancing a portfolio of different mechanisms: an oral GLP-1, formerly known as 5004, now called azelaprag, a selective amylin receptor agonist, AZD6234, and a GLP-1 glucagon, AZD9550, all of which are expected to report first phase 2 data this year. Our goal is to address weight management and cardiometabolic risks holistically, and our broad pipeline uniquely positions us to explore innovative novel combinations. Should phase 2 data demonstrate competitive profiles, we plan to rapidly move to broad phase 3 trials in 2026. Following the acquisition of CinCor, announced at this conference two years ago, we have been excited to see baxdrostat emerge as the potential best-in-class aldosterone synthase inhibitor for uncontrolled and resistant hypertension, with compelling data from both the Bax HTN and the BaxCS24 phase 3 trials.
The FDA recently accepted Baxdrostat with priority review, and we anticipate being first to market with a PDUFA date in the second quarter of this year. We look forward to leveraging our strong existing foundation in primary and specialty care in the U.S., as well as our global reach to maximize the value of this medicine. This provides us with a considerable competitive advantage, and we're investing strategically to support the Baxdrostat launch, anticipating initial uptake with specialists, followed by broader adoption in primary care, as is typical for a cardiovascular launch. Turning to oncology, we're rapidly advancing a broad, high-value portfolio of antibody drug conjugates. We now have eight wholly owned ADCs in the clinic, giving us the potential to address around 80% of the patient population in our focused solid tumor areas.
We anticipate the first pivotal data for Soni V, our Claudin 18.2 ADC, in the first half of this year for second-line gastric cancer, with plans underway to move into the first-line setting. We've also rapidly progressed both Payasam, our B7-H4 ADC, and Torvosan, our folate receptor alpha ADC, into late-stage development, with first subjects initiated in phase 3 trials in the second half of 2025 in endometrial and ovarian cancers, respectively. These are the first ADCs to move into phase 3 using AstraZeneca's proprietary linker payload technology. Looking forward, we're excited by the potential to integrate our proprietary QCS technology into future trials, enabling us to better identify and target patients most likely to benefit from these innovative therapies. At ESMO last year, we presented encouraging updated Phase 1- 2 data from our ARTEMIDE-01 study for rilvegostomig, our PD-1 TIGIT bispecific.
We demonstrated promising activity in checkpoint inhibitor naive non-small cell lung cancer cohorts, highlighting the opportunity Rilvegostomig has to replace current generation immune checkpoint inhibitors. We also shared promising early data for Rilvegostomig in combination with our TROP2 ADC, datopotamab deruxtecan, in lung and breast cancer. We have a broad program, which includes 14 ongoing phase 3 trials across nine tumor types, including lung and GI cancers. Last month at ASH, we presented early data for our cell therapy asset, AZD0120, and T-cell engager, sabestomig. Both assets have $5 billion plus non-risk-adjusted peak revenue potential. AZD0120 is our dual CD19 BCMA CAR-T therapy that has demonstrated a potential best-in-class profile in multiple myeloma, with Phase 1b data demonstrating a 78% complete response rate in late-line patients and an 80% complete response rate in those previously treated with a BCMA CAR-T.
This remarkable efficacy, combined with the favorable safety profile observed, including no grade 3 or higher cytokine release syndrome or delayed neurotoxicity, highlights the potential of this asset. phase 3 trials in multiple myeloma are planned to start this year, and we're also exploring early development outside of oncology in phase 1 trials in SLE, myasthenia gravis, and light chain amyloidosis. Survatimig, our CD19 CD3 bispecific T-cell engager, has transformative potential across multiple hematological malignancies. phase 1 data showed high response rate across DLBCL, follicular lymphoma, and ALL, with a manageable safety profile across trials. phase 3 trials in DLBCL and follicular lymphoma are ongoing, and we look forward to expanding the late-stage program in 2026. Our capital allocation priorities remain unchanged, and reinvestment in our business remains our top priority.
Looking ahead, 2026 is set to be another catalyst-rich year for AstraZeneca, with multiple high-value phase 3 readouts anticipated across therapy areas. Just to highlight a few, in Oncology, we anticipate several readouts for datopotamab deruxtecan in non-small cell lung cancer, further data on Imfinzi in bladder cancer and early HCC, a first pivotal readout for our claudin 18.2 ADC, Soni V, as well as next-generation oral SERD camizestrant in first-line hormone receptor-positive breast cancer. In BioPharmaceuticals, we're looking forward to the readout of Wainua in ATTR cardiomyopathy and the COPD program for differentiated IL-33 biologic tozorakimab. Finally, in rare diseases, we anticipate readouts for indication expansion opportunities for Ultomiris, as well as asfotase alfa program throughout with readouts in hypophosphatasia. In closing, we deliver strong growth in 2025 while advancing an industry-leading late-stage pipeline.
We remain on track for our 2030 ambition, and we're building beyond, investing in transformative technologies with innovations that hold the potential to reshape standards of care throughout the next decade. Our diversified portfolio and global reach provide resilience in an ever-changing external environment, and our disciplined capital allocation ensures that we can fund innovation and generate returns. And with that, I would like to thank our hosts, J.P. Morgan, and would like to move over to Q&A along with Dave. So thank you very much. Thanks, Aradhana. Maybe I'll kick off with one question to start with. You highlighted the 2030 ambition, and you also highlighted the 19 phase 3 readouts, the successful readouts. And we've seen Baxdrostat, we've seen Enhertu, we've seen Camizestrant, among others. So what are you thinking about the potential to get there, the achievability of that, and your level of confidence there?
Of the assets that you've highlighted, what are we underappreciating from our side as consensus?
So we set this $80 billion target last year, not last year, the year before, 2024, in May of 2024. And at that time, it was obviously a stretch target. It was risk-adjusted. And obviously, we felt it was within reach. And you fast forward a year and a half later, I think we do feel it is very much within reach. And we have a whole lot of, if we have the same success rate this year as we had last year for phase 3s, then I think the confidence increases even further. A good data point, I think, to maybe remind folks, when we had put out that target in May of 2030, consensus estimates for us, for AstraZeneca in 2030, were $67 billion, and we had put this $80 billion target.
Last year, mid-2025, those moved up to closer to like $76, and now they're actually at $80. So I think people are getting more confident.
Yeah, I think, Richard, on this, just within the oncology portfolio, first, having 10 positive phase 3 readouts in oncology turns over a lot of cards that we get to play now between now and 2030. When I look at four of our current multi-blockbuster medicines, Imfinzi, Enhertu, Calquence, Tagrisso, I continue to see with those medicines opportunity to grow to 2030 and beyond. We've got Matterhorn in hand, DB09 in hand, Destiny- Breast0 5, 11 in hand, Amplify. These are all indications that are substantial and that we've got a really nice opportunity to drive great growth on. Then on top of that, Aradhana talked about the hematology portfolio. I think 0120 and Rilvegostomig are underappreciated, to be very specific to your question. We remain very enthusiastic about the next-generation SERDs, and I think actually as a class, we're seeing read-through that give us increasing confidence in Camizestrant.
And then Aradhana also talked about the ADCs, and we'll see the first, it's up on the slide, right? So you see the first of the AZ wholly owned ADCs with Soni V coming through this year, and I think that we've got a really strong platform to be very competitive within the space.
You touched on the SERDs. We've obviously seen data from your competitor in the adjuvant setting. Maybe you could expand a little bit on what that says for your program, both in the adjuvant setting with the SERENA trials and also maybe thinking about building on SERENA- 6. This year, we have SERENA 4.
As we've often said, we do believe that not all molecules are the same within a class, and obviously, there's different approaches and strategies to development programs. We do believe, based on the data that we've seen to date, that we've got a best-in-class SERD in terms of mechanism of action, but then also the clinical data that we're seeing from that. Some of the most compelling clinical data are obviously the early work with SERENA-2, where we took a look at the combination of Faslodex plus the SERD versus Faslodex. Within that context, we're really, really encouraged to see that both in patients whose tumors had an ESR1 mutation, but also those who didn't, that we saw similar magnitudes of efficacy in terms of hazard ratio. Of course, SERENA-6 gives us a good reason for confidence in the class.
And then the adjuvant readouts coming from competition give good positive read-throughs into the hypothesis that we can do better than AIs. We've got, with our SERENA-4 study, which we'll read out, as you can see here in the second half of the year, we think that we've got a study that's appropriately sized. We think that we've really included patients in it that are still those patients with endocrine drive and will be endocrine sensitive, and we think that's been an important part of the design of that study. And we know that CDK4/6s are playing an increasingly important role in the treatment of both early and metastatic, and that's part of our program. So we've got a really broad program, four studies with SERENA-4, SERENA-6, CAMBRIA-1 and CAMBRIA-2.
I think that we've been smart in terms of lots of different shots on goal, but also opportunities to make sure that we are on time and bringing data in a timely fashion in the marketplace.
Makes sense. You alluded to on Imfinzi lots of clinical data, Matterhorn. You've been driving indications, Adriatic, Aegean, and beating estimates over the last year. How should we think about the peak sales for that opportunity for Imfinzi? Where can we go?
So this year, and sorry, last year in 2025, the key growth areas have been GI cancers. So not only, as you mentioned, obviously the work that's happening and starting to see underway within Matterhorn, but really Himalaya being an important part of the growth that we've seen. GU, so bladder cancer, with Niagara being an important area, and then small cell lung cancer with Adriatic being an important piece going ahead. And all the while within that, I think very important to remember, Richard, very strong position in the stage three unresectable Pacific setting. This has been an area where, despite competition, we remain the IO of choice and the only one that's really approved in this setting. I think that GU, GI, and small cell continue to grow going forward. I think that we'll continue to see that. How big could we be?
I think that you take a look within this. Certainly, Imfinzi with Imjudo could have the opportunity to come into the stage four setting. We have very little sales of Imfinzi in stage four lung cancer, so this would be a really nice opportunity to grow into that setting. Continuing also with Emerald 3 and volrustomig, those are important and big opportunities to grow ahead. Imfinzi, I think, will likely be our largest oncology medicine in the midterm period. That's not because Tagrisso is not going to be doing well. It's just because I think Imfinzi's got more engines to grow off of.
You touched on Dato-DXD. We've seen T-DXd, we saw great data at ESMO, but I just wanted to ask about what you're seeing in the launched indications. How's the uptake going? And on T-DXd, how are you thinking about the potential there given the strong data and the good tolerability?
Launch trajectories in our lung and breast indications are well underway and doing nicely. It really does demonstrate that there's a real need and an appetite to replace classic chemotherapy with new, more precision-targeted options. TROP2 was so important because this is a population where there's no doubt that chemotherapy is today the standard of care, and an opportunity to bring a more precise approach with TROP2 into this triple-negative population is highly sought after. We also got an opportunity to see in a cross-trial comparison way that Datopotamab deruxtecan compares very well to the other in-class competition and studies that were pretty similarly set up and designed to one another and, in fact, presented at the same congress, and so I think that was really useful for us to see. If you compare also then and take a look, that TROP2 indication, that's a blockbuster opportunity for the brand.
And I think if you then look at that, you start to say, well, we've de-risked a very important part of the breast cancer opportunity through TB02. And I think that we're starting to get good positive experiences with the medicine, and we're looking forward to really the further readouts that are happening over the year.
Maybe touch on one earlier oncology pipeline, the BCMA CAR-T that Aradhana, you mentioned, and you mentioned going into phase 3. Maybe just the details of where could you go, how fast could you go? Obviously, this is late stage, but can you go into the earlier stages of multiple myeloma?
Absolutely. I mean, I think that Aradhana showed the fact that we're seeing really strong efficacy in the way of response without CRS, without delayed neurotoxicity. These are the liabilities that are preventing CAR-T from moving from the later line settings where they've been highly effective into the newly diagnosed setting, so if we continue to see a profile as we've been seeing so far to date and presented at ASH, our ambitions for AZD0120 are absolutely to move into the earlier stages, and Aradhana made the point, and I think it's really important and absolutely something that's probably not on the collective radar. The opportunity to move into autoimmune and also into rare disease, I think, is substantial as well.
We'll need to share more data as it comes available on the successes that we're having there, but we are starting to really get increased enthusiasm and ambition to be able to move our CAR into those spaces.
Makes sense. Maybe we could just pivot for a moment to policy. It's been, or rather 2025, was an eventful year in terms of policy in the U.S., and you had one of the first White House agreements. But there is the ongoing IRA negotiation. So maybe a couple of questions here. Just how should we think about the impact of your White House deal on 2026? And then I think Calquence might be subject to IRA in 2027, so we're going to see that on a list and then into the negotiation. So how should we think about that as well?
On your first question, as it relates to the Most Favored Nation definitive agreement, I think what's really important is a starting point. You've heard Pascal comment on this, and it's a really important first piece, which is the disparity in funding for innovation that has been taking place and growing over the last decade among wealthy nations we don't see and didn't see as sustainable. It's very clear that there's a big gap that exists here, and I think that this is an opportunity to address that. The fact that we now have, I think it's 16 now of 17 companies that received a letter from the president, have now signed on to agreements also means that there's an opportunity for there to be some real scale and inertia behind increasing the funding for innovation across the globe in a more balanced way.
And so as you think about the impact specifically to your question in 2026, I think one of the things that we were encouraged by with the administration, and you'll have the administration here later today at lunch, but that the administration understood the nuanced aspects of ensuring that life sciences continue to be competitive and robust within the United States, and that meant a phased approach to the work that we're doing. The phased approach on MFN is going to start first with America's most vulnerable and Medicaid, which for us represents low single digit of global sales. Over time, it'll grow to represent multiple channels of business and multiple medicines, but it gives us the opportunity to plan to get towards that and to offset by increasing funding for innovation across the globe as the U.S. prices come down.
So I think that the 2026 impact is going to be within a defined population of the Medicaid population, and I think that that's something that we've got so many growth drivers that are happening that I think that we manage that well, and it'll obviously be incorporated into whatever guidance we provide at the front end of the year. On IRA, I expect for Calquence to continue to be the leading frontline CLL, both in continuous and as we launch within Amplify, opening up into finite, and we'll be the only all-oral fixed duration frontline CLL option in the U.S., and I think we've got great growth opportunity there.
Excellent. I mean, one of the readouts on the slides is Wainua, which is, and we've seen a very strong uptake for Amvutra from Alnylam. So maybe we could just talk a little bit about how you see Wainua being differentiated, what's the difference in trial designs, and how you see the relative profiles.
Yeah, so the study that's ongoing right now is the largest study ever done in the cardiomyopathy population. And we specifically increased the size of the study. In terms of the design, the way I would say the key differentiation other than the size is the fact that we're also looking at mortality endpoints, not just all-cause mortality, but also cardiovascular mortality. And then secondly, because of, again, the size of the study, we will also have data in the population, which is non-familial, for example. So again, that data is not, Wainua doesn't have that, and I think that will be a key differentiator.
Other than that, I think we feel because of our global and very strong cardiovascular presence for many decades, obviously with Farxiga, but then now also with Baxdrostat and our entire portfolio, we're really well positioned to commercialize this, assuming obviously the trial reads out positive. The other element I would say is diagnosis rates still remain very, very low in this indication. So Alana's doing a great job, but there still is a huge opportunity to improve diagnosis, have earlier diagnosis, and expand the entire patient population.
On the slide, there's a couple of, or maybe three readouts on obesity in the portfolio that you highlighted. Maybe we could drill down on one of them, the glucagon GLP-1. The obesity space is sort of, it's evolving, shall we say. So where does this fit?
Yeah, I mean, it's hard to predict really how the obesity space will evolve. We have sort of one worldview of what the universe will look like five years from now, and I'm sure everybody has their different worldview. But our view is that the market will segment over time. There'll be a role for injectable GLP-1s, but there'll also be a big population for oral GLP-1s. Then there'll be more elements like the amylin or the injectable GLP-1 glucagon, which may be as a monotherapy, but potentially also in combination. And patients will segment based on not just sort of weight loss, which has really been the only element people are measuring, but other comorbidities, lean muscle preservation, what effect there is on kidney disease or heart disease.
So I think there'll be further subsegmentation, and that's why our strategy also on the oral side is to do combination like the AZD5004 in combination with Dapa and so forth. So again, based on our worldview, we have a whole program for many of these assets to fit in different areas and to address different conditions.
Makes sense. We've got one or two questions on the panel, so I'll just ask one of them, which is on Tagrisso, Dave, which is they're just asking how are you thinking about next generation EGFR portfolio from your side in terms of lifecycle management and longer growth of that portfolio?
So we're continuously looking for opportunities to raise the bar and beat Tagrisso. Right now, the near- and midterm opportunities to do that are through Tagrisso combinations. We're building on top of the FLAURA 2 experience. And one of the things that's been really important coming out of the FLAURA 2 overall survival data is a real shift in the lung cancer community's interest in moving from monotherapy Tagrisso for most and combo as the exception to now really combinations for most and mono for those who likely aren't going to be able to benefit from combination. So you see within that context that you've got TROPION-Lung01 , which is a second line study. We also have the frontline studies that we're looking at there, other options to also, ideally, we'd like to be able to bring in other ADC combos with Tagrisso into the space as well.
We'll continue to share information as we have it becoming available. We're working hard on a next generation Tagrisso, but right now, I think that for investors to have on their radar, it's really the combinations of OSI-based combos that I think is where the next opportunity for improving on outcomes resides.
Makes sense. Maybe one last question from me. You talked upfront in the Q&A about the 2030 target, $80 billion. In your presentation, you highlighted the ambition to grow beyond that, beyond 2030. I suppose the simple question is, what's driving the confidence there? What within the portfolio, etc., can we anchor on to give us confidence in that continued growth?
I mean, I'd say actually a lot of the studies you see here and next year when we have the same list of 2027 readouts, many of these actually don't reach their peak sales in the 2030 timeframe, right? Actually, they contribute very little of that $80 billion ambition. So if you think of like Camizestrant, what they've talked about and the early Cambria 1, Cambria 2 stuff, those will be things that contribute to the post-2030. Our oncology, we have the bispecific, we have 10 different phase 3 studies. That's not going to contribute a whole lot before 2030. That's sort of the post-2030. Same with the hematology portfolio, whether it's 0120. So there's a lot in sort of the post-2030 timeframe, but those investments we're making today and those readouts may happen in 2027, 2028, 2029, but real revenue contribution won't be until post-2030.
That's why we continue to make all these investments and have a high investment in R&D.
Perfect. Aradhana, David, thanks very much.
You're welcome.
Thanks, everyone.
Thank you.