Good morning to those joining from the U.K. and the U.S. Good afternoon to those in Central Europe, and good evening to those listening in Asia. Welcome to AstraZeneca's Q1 2026 webinar for investors and analysts. Before I hand over to AstraZeneca, I'd like to read the Safe Harbor Statement. The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.
The company undertakes no obligation to update forward-looking statements. Please carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webcast. There will be an opportunity to ask questions after today's presentation. Please use the Raise a Hand feature to indicate you wish to ask a question at any time during the call. With that, I'll now hand you over to the company.
A warm welcome to AstraZeneca's Q1 2026 presentation conference call and webcast for investors and analysts. I'm Joris Silon, Head of Investor Relations. Before I hand over to Pascal and the members of our executive team, I would like to cover some housekeeping items. All of the materials presented today are available on our AstraZeneca investor relations website. Next slide. This slide contains our forward-looking statements, including the safe harbor provisions, which I would encourage you to take the time to read. We will be making comments on our performance using constant exchange rates or CER, core financial numbers and other non-GAAP measures. A non-GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of U.S. dollars, unless stated otherwise. Next slide, please. This slide shows our agenda for today's call. Following our prepared remarks, we will open the line for questions.
As usual, we will try to address as many questions as we can during the allocated time. Please limit the number of questions you ask to allow others a fair chance to participate in the Q&A. With that, please advance to the next slide. Pascal, over to you.
Thank you, Joris. Welcome everyone. Next slide, please. We delivered a strong Q1 building on the momentum we generated in 2025. Total revenue grew 8% in the quarter, supported by robust demand for innovative medicines. We saw strong growth in operating profit, which increased 12%, reflecting our ongoing focus on operating leverage. Core EPS grew 5%. Our EPS growth was held back by the low tax rate in the prior period. Since our Q4 2025 results, we have secured 14 approvals in major regions across our diverse portfolio, a clear illustration of the value our medicines bring to patients globally. Additionally, we continue to see strong delivery from our pipeline. In the past weeks, we announced results from four positive phase III programs, including two NMEs, Tozorakimab and efzimfotase alfa.
We continue to invest in our commercial capabilities, both to support ongoing launches and multiple future launches such as Baxdrostat, Camizestrant, and Tozorakimab. In R&D, we continue to invest in our pipeline, including our transformative technologies. Please move to the next slide. The breadth of our business remains a competitive strength, with a solid growth outlook across therapy areas and key markets. Oncology and rare disease saw strong double-digit growth, while high demand in R&I was offset by loss of exclusivity in CVRM. We saw strong performances across our key regions. Our largest market, the United States, grew at a double-digit percentage, benefiting from our investment behind recent launches, with Europe and emerging markets growing at high single-digits. Importantly, we continue to deliver impressive growth in the emerging markets, with ex-China revenues up 9%, reflecting the benefit of our sustained presence in this market.
Revenues in China increased by 2%, with VBP implementation impacting Forxiga, Lynparza, and Roxadustat growth. We are confident in our growth outlook in China based on the positive 2026 NRDL outcomes. Next slide, please. In the Q1 , we saw a continuation of the successful clinical trial delivery seen in 2025. We announced four positive high-value programs, reinforcing the continued progress we're making towards our 2030 ambition and beyond. We look forward to discussing the significant potential of these readouts during this call. With that, I will hand over to Aradhana to take you through our financials. Please advance to the next slide.
Thank you, Pascal, and good morning and good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please. As Pascal has already highlighted, we saw very good top line momentum in the Q1 , with total revenue increasing by 8%. Product revenue consisting of product sales and alliance revenue also increased 8%, with continued growth seen across all key regions. Alliance revenue increased by 26%, reflecting our increased profit shares for our partnered products in HER2 and Tezspire in regions where our partners book product sales. Next slide, please. This is our core P&L. The core growth margin in Q1 was 83%. For the full year, we continue to anticipate a stable to slightly higher core growth margin versus 2025. Core R&D expenses increased by 8%, driven by continued acceleration and investment in our pipeline.
The number of active clinical trials increased by 10%, and the number of patients enrolled in our studies increased by 30% compared to Q1 last year as we continue to bring new innovative medicines to patients while creating value for our shareholders. As previously highlighted, we continue to invest in transformative technologies, including cell therapies and T-cell engagers to drive growth also beyond 2030. As a percentage of total revenue, core R&D costs accounted for 23% in the Q1 . For the full year, we continue to expect core R&D costs to be at the upper end of the low 20s percentage range. Core SG&A costs increased by 7% in the Q1 . This was partly driven by pre-launch investments behind Baxdrostat, which has a U.S. PDUFA date in the Q2 of 2026.
As you've seen, we have had a great start to 2026 in terms of R&D, with success in four high-value programs, including Tozorakimab, which will require SG&A investment to maximize their potential. In addition, we have several other upcoming launches for products with high-value potential, including Baxdrostat, Camizestrant, and Tozorakimab, all of which will help drive growth through 2030 and beyond. Other operating income increased to $189 million, with some non-recurring milestones booked in the quarter. Core operating profit grew by 12%, reflecting a strong underlying performance. Core EPS grew by 5% to $2.58, with growth rate impacted by low tax rate in Q1 2025. Next slide, please.
Cash flow from operating activities of $3.4 billion was a slight decline versus the same period last year due to large milestone receipt in Q1 2025, but partly offset by strong underlying performance. CapEx of $600 million includes previously announced multi-year investments, such as our new ADC manufacturing facility in Singapore and our new manufacturing plant in Qingdao, China, for an inhaled respiratory portfolio. We continue to anticipate CapEx to increase by around a third in 2026. Deal payments of $1.1 billion include milestone payments to partner and an upfront payment for the Jacobio license agreement announced last year. We have now paid the last royalty payment for Farxiga. For the full year, we continue to anticipate milestone payments of around $2.5 billion relating to past transactions. The recent CSPC deal closed in April, so will be booked in the Q2 .
Our capital allocation priorities remain unchanged. Net debt increased by around $2.5 billion in the quarter, driven by a payment of the second FY 2025 interim dividend in March. We are comfortable with our current level of gross debt, and as previously indicated, we anticipate core finance expenses to increase this year, driven by higher lease expense and lower interest income. Today, we are reiterating our full year guidance. Total revenue is anticipated to increase by mid-to-high single-digits percentage, and core EPS is anticipated to increase by low double-digit percentage at constant exchange rates. Based on average March exchange rates, we anticipate a low single-digit positive FX impact on total revenue and a neutral impact on core EPS.
In summary, a very strong financial performance in the quarter, and with the investments we are undertaking, both in R&D and behind new launches, we are well-placed to grow through 2030 and beyond. With that, I will hand over to Dave, who will take you through the business performance of our oncology business.
Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the Q1 to $6.8 billion, with double-digit growth across all reported geographic segments. Performance in the U.S. and Europe was particularly strong, with growth of 18% and 19% over the prior year, respectively, continuing the momentum demonstrated through 2025. Turning now to quarterly performance of our key medicines, Tagrisso grew 5% in the quarter to revenues of $1.8 billion. Performance was driven by robust demand across all stages of EGFR mutated lung cancer in the U.S. and Europe, partially offset by higher than historic destocking in the U.S. In the frontline setting, Tagrisso remains the treatment of choice, with an increasing proportion of physicians opting for the FLAURA2 combination. We anticipate continued growth over the balance of the year across all indications.
Our foundational Immuno-Oncology assets Imfinzi and Imjudo delivered growth of 28% in aggregate. Imfinzi growth of 30% was, as in previous quarters, underpinned by robust demand growth across all regions. We are seeing an increasing contribution from more recent launches such as MATTERHORN in gastric, NIAGARA in bladder, and ADRIATIC in lung cancer, alongside continued growth in more established indications such as HIMALAYA and TOPAZ-1. With continued strong demand for Imfinzi and Imjudo across indications, we are well-positioned to sustain growth throughout the remainder of 2026. Calquence revenues grew 17% in the quarter to more than $900 million, with double-digit growth in all major regions. Focusing in on the U.S., Calquence continues to maintain its share leadership position in the frontline CLL setting despite intense competition.
Our finite regimen for frontline CLL based on AMPLIFY is gaining momentum in reimbursed European markets and driving incremental new patient starts. While too early to comment on the trajectory in the U.S., excitement is building among prescribers, and we believe AMPLIFY will be a key contributor to growth this year. Turning to Enhertu, which is now annualizing as a $5 billion brand on an alliance view, we delivered growth of 34% in the quarter, which was balanced across regions. This growth reflects ongoing demand in both the HER2-positive and HER2-low breast indications. In China, the exceptional performance we saw through 2025 post-NRDL enlistment continues into 2026, with share gains in both HER2-positive and low breast cancers.
We're also seeing encouraging early signs of adoption of HER2 in first-line HER2 positive breast cancer in the U.S. following the DESTINY-Breast09 approval in December last year. We look forward to broadening our reach further with additional launches into early HER2 positive breast cancer later this year. Truqap revenues of $198 million in the quarter represents 47% growth over the prior year. We expect some further growth to be delivered in ex-U.S. markets, and we see U.S. market share at peak. Datroway revenues of $43 million in the Q1 reflect ongoing demand in the U.S. in later line EGFR-mutated lung cancer, with more than one in three third-line patients now treated with this medicine. Following its acceptance for priority review, we look forward to the U.S. approval of TROPION-Breast02 later this quarter.
This has the potential to drive significant further growth for Datroway, given the differentiated profile demonstrated in patients with metastatic triple-negative breast cancer that are not candidates for immunotherapy, an area of high unmet need. After a robust Q1 performance, we are excited about the outlook for the remainder of the year as we continue to deliver transformative regimens to more patients across the globe. With that, please advance to the next slide, and I'll hand over to Susan to cover key R&D highlights from the quarter.
Thank you, Dave. Earlier this month, we announced the positive results of the phase III EMERALD-3 trial. Building on the success of HIMALAYA in advanced liver cancer, EMERALD-3 now moves Imfinzi in combination with Imjudo into the earlier local regional setting with the goal of transforming outcomes for more patients with hepatocellular carcinoma. EMERALD-3 is a three-arm trial investigating whether the STRIDE regimen made up of a single priming dose of Imjudo together with regular interval dosing of Imfinzi with or without lenvatinib can improve outcomes when given before and then alongside standard of care transarterial chemoembolization or TACE. Data from the primary analysis are very encouraging, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for the STRIDE plus lenva arm with a positive trend to overall survival.
The STRIDE-only arm also demonstrated a strong trend to both PFS and OS benefit, although this arm was not formally tested at this time. We await further follow-up and are excited by the potential EMERALD-3 offers for the more than 200,000 patients with local regional HCC currently eligible for embolization. We look forward to presenting the data at ASCO. EMERALD-3 marks the beginning of a series of high-value Imfinzi readouts over the course of 2026. In the coming months, we expect results from VOLGA, which will complement our NIAGARA indication in muscle-invasive bladder cancer and further reinforce our position in genitourinary cancers.
In the second half of this year, we have two datasets that present opportunities to further broaden use of Imfinzi in lung cancer, with AVANZAR aiming to improve outcomes and significantly expand Imfinzi's reach in the first-line metastatic setting, and PACIFIC-9, which looks to consolidate and deepen our leadership in stage III unresectable disease. Imfinzi is the current backbone of our immuno-oncology franchise, and we're excited by its potential to become standard of care across an even broader range of tumor types and settings. We're also excited to highlight several new developments from our oncology pipeline that will be presented at ASCO this year. Our in-house ADC program continues to progress at pace. We look forward to sharing more data on puxitatug samrotecan, our B7H4-directed ADC in endometrial and ovarian cancers.
We're also excited to be moving forward with our plans to open two further phase III trials for our folate receptor alpha-targeted ADC, AZD5335, in ovarian cancer later this year. We will also share further data for Enhertu, including HER2-positive gastric cancer from a broad global population, which supports the ongoing phase III CLARITY-Gastric 01 trial, now expected to read out in the second half of this year. Also at ASCO, additional evidence supports the use of our PD-1/TIGIT bispecific rilvegostomig in combination with Enhertu in gastric cancer. Early phase data for rilvegostomig in head and neck cancer will also demonstrate safety and efficacy in this indication. Finally, I want to highlight that we will present impressive first-in-human data for our PRMT5 inhibitor, AZD3470, in a heavily pretreated classical Hodgkin lymphoma population, strengthening our expanding hematology pipeline.
ASCO 2026 looks set to be another significant congress for AstraZeneca. With that, please advance to the next slide, and I'll pass over to Ruud to cover BioPharmaceuticals' performance.
Thanks, Susan. Next slide, please. Our BioPharmaceuticals total revenue was broadly stable in the quarter, with growth in key brands mostly offsetting the anticipated headwinds from Brilinta, Farxiga, and roxadustat. Overall, BioPharmaceuticals total revenue declined by 2% to $5.8 billion. Our respiratory immunology portfolio was up 7% to $2.3 billion. This performance was driven by our key brands, which grew 18%. Within the portfolio, Fasenra delivered another strong quarter, growing 11% to reach $483 million. This was supported by strong uptake in China following its NRDL listing, with revenues in emerging markets up 63%. Breztri generated $353 million in revenue, growing by 13%. Earlier this month, Breztri achieved its first label expansion beyond COPD with U.S. approval for asthma.
Breztri is now the first and only triple therapy in asthma approved for patients aged 12 and older. Regulatory reviews continue in other countries. Tezspire continues to perform well and delivered $303 million in revenue, representing a growth rate of 34%. Tezspire is now approved for chronic rhinosinusitis with nasal polyps in all major markets following approval in Japan and China this quarter. Saphnelo grew 24% to achieve $171 million in revenue. The new subcutaneous formulation is now approved in Europe, the U.S., and Japan, which extends its reach to the large segment of patients who favor self-administration. 2026 marks a transition year for CVRM as we navigate loss of exclusivity headwinds ahead of the launch of several key pipeline medicines and new indications.
CVRM total revenue for the Q1 stood at $3.3 billion, representing a decline of 6%. Farxiga total revenue fell 3% to $2.2 billion. Farxiga has a phased LOE profile and in Q1 , that LOE effect was seen and established the rest of the world, and also with the implementation of VBP in China. As expected, generic manufacturers entered the U.S. market in April. Our U.S. markets continue to perform well, fueled by Farxiga's market share leadership within the fast-growing SGLT2 inhibitor class. Lokelma achieved global market leadership in the potassium binder class and $199 million in the quarter, reflecting growth of 26%. Our commercial teams are preparing for the launch of Baxdrostat later this year, with the PDUFA date for FDA regulatory decisions set for Q2 .
If approved, Baxdrostat will be the first aldosterone synthase inhibitor to serve patients with uncontrolled and resistant hypertension. In 2026, we anticipate gaining commercial access, and over time, we expect to see broader use across patients eligible for Part D reimbursement in line with the typical negotiation cycle. With the new approval for Breztri in asthma, the anticipated Baxdrostat launch, the recent success of Tozorakimab phase III COPD program, and the upcoming results from Wainua ATTR-CM trial, we have much to look forward to across BioPharmaceuticals this year. I will now hand over to Sharon to take us through the exciting Tozorakimab readouts in more detail.
Thank you, Ruud. Next slide, please. I am delighted to share the significant progress from our respiratory pipeline this quarter with compelling new data that underscore our commitment to pioneering science and addressing the most urgent challenges in respiratory disease today and for the future. We recently reported high-level results from our three pivotal phase III studies and long-term extension study in our LUNA program studying Tozorakimab in COPD, Oberon, TITANIA, MIRANDA, and PROSPERO. This represents the most comprehensive phase III program ever conducted for a COPD biologic, and the results reinforce our confidence in Tozorakimab's potential to be a first and best-in-class treatment option for patients living with this devastating disease. COPD remains a critical area of unmet medical need. It is the third leading cause of death globally, claiming over three million lives each year.
Even when patients are on inhaled standard of care, approximately half still experience exacerbations, which amplifies their risk of cardiovascular events, including heart attack, stroke, or even death. Importantly, only 50% of patients live more than 3.5 years after their first severe COPD exacerbation. These statistics underscore why innovation in COPD is so urgently needed. What sets Tozorakimab apart is its dual-acting mechanism and the breadth of our clinical program. This is a true AstraZeneca science success story. Over a decade ago, our scientists uncovered IL-33's two distinct forms and their role in COPD. Our research confirmed the reduced form of IL-33 activates immune cells through the ST2 pathway. They also discovered that IL-33 released from cells undergoes oxidation and converts to a different form, which activates the RAGE/EGFR pathway and the cycle of mucus production in COPD.
These discoveries informed the development of Tozorakimab, a differentiated molecule which uniquely inhibits the signaling of both, reducing the inflammation and breaking the mucus dysfunction cycle which drive disease worsening. In OBERON and TITANIA, Tozorakimab achieved statistically significant and highly clinically meaningful reductions in the annualized rate of moderate to severe exacerbations. This efficacy was seen in former smokers and in the overall population, which included former and current smokers and had patients independent of eosinophil levels and lung function severity. MIRANDA, testing in every two week regimen, showed clinically meaningful benefits in exacerbation reduction as well. These results are truly exciting, marking the first time a biologic has demonstrated efficacy in COPD in three pivotal trials that enrolled broad populations. These results are further supported by PROSPERO, the long-term extension study of OBERON and TITANIA.
While the narrower primary endpoint of severe exacerbations, those leading to hospitalization or death, did not reach statistical significance in former smokers, we observed a numerical reduction in this population and a nominally significant reduction in the overall population. Tozorakimab was well-tolerated with a favorable safety profile across the entire program. We are working at pace to share these data with the regulatory authorities and the scientific community. With approximately six billion biologic-eligible patients globally, Tozorakimab has the potential to address the broadest population of COPD patients. Please proceed to the next slide, and I'll pass over to Marc to cover rare disease.
Thank you, Sharon. Can I get the next slide, please? Rare disease delivered total revenue of $2.4 billion in Q1 , up 15% year-over-year. This is driven by growth in neurology and metabolic diseases, increased patient demand, and continued global expansion. If you recall, Q1 2025 performance included transitory headwinds, most notably tender market order timing for both Soliris and Strensiq. In the quarter, Ultomiris grew 18%, driven by patient demand across indications, including the competitive myasthenia gravis and PNH markets. Soliris revenues continued to decline due to successful conversion to Ultomiris, as well as biosimilar pressure. This was partially offset by favorable order timing in certain tender markets. Strensiq grew 43% year-on-year, reflecting strong underlying demand and a favorable comparison versus the prior year.
We saw demand growth for Koselugo, including the newly launched adult indication for NF1 PN patients. We continue to see great momentum across the rare disease portfolio. Please advance to the next slide. I'm delighted to announce a positive high-level result for our phase III programs in rare metabolic and renal diseases. efzimfotase alfa, our next-generation enzyme replacement therapy, demonstrated positive result from the global phase III clinical program for patient with HPP. The Mulberry trial in treatment-naïve pediatric HPP patient met its primary endpoint, showing meaningful improvements in bone health as well as other objective endpoint, including physical function and quality of life. In parallel, the Chestnut phase III trial showed that efzimfotase alfa was well-tolerated in children, switching from Strensiq while maintaining benefit on bone health.
In the HICKORY phase III trial in adolescents and adult with HPP, efzimfotase alfa demonstrated numerical improvement but did not achieve statistical significance in the primary endpoint of six-minute walk test in patients who have not been previously treated with Strensiq compared to placebo. The results show clinically meaningful impact on mobility, physical function, pain, and fatigue that are key aspects of this heterogeneous disease that are beyond one single endpoint, such as a six-minute walk test, the only approved adult endpoint. efzimfotase alfa represents patient-centered innovation, improving upon Strensiq profiles for a longer half-life, more patient-friendly dosing, and an improved manufacturing process. The phase III trials were designed to reflect the broad symptomatology of HPP, efzimfotase alfa is well-positioned for broader global adoption by removing key barriers to access. There are approximately 14,000 addressable HPP patients across the top eight countries.
Approximately 20% of these are pediatric cases, 60% adult with pediatric-onset disease, and 20% adult with adult-onset disease. We will share data across the program with regulators and present at an upcoming medical meeting. We believe efzimfotase alfa represents a peak year sales opportunity of $3 billion-$5 billion. In addition, we recently announced positive high-level result from a pre-specified interim analysis of the ICAN phase III trial, which showed that Ultomiris met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in proteinuria based on 24 hours in urine protein creatinine ratio at week 34 in adults with IgAN who are at risk of disease progression. The primary endpoint of change from baseline in estimated glomerular filtration rate will be measured at week 106. Ultomiris demonstrated complete and sustained terminal complement inhibition, with proteinuria reduction seen as early as week 10.
Benefits are consistent across patients, including those at higher risk of progression and with more inflammatory disease. Importantly, updated 2025 KDIGO guidelines recommend using disease-modifying agents such as Ultomiris in combination with supportive medicine that manage a disease symptom such as RAS or SGLT inhibitors. Across U.S., Japan, and the EU5, there are over 560,000 patients diagnosed with IgAN, and 60% of patients would be eligible for IgAN treatment based on proteinuria. We are confident this indication could reach blockbuster potential given our established nephrology presence across AstraZeneca and Alexion, and we are seeking accelerated approval in key markets. Today we disclosed the discontinuation of Ultomiris in CSA-AKI high-risk patients with kidney ischemia due to lack of consistent efficacy across CKD severities.
Finally, I'm pleased to report that CALYPSO, a phase III trial investigating the safety and efficacy of eneboparatide in adults with chronic hypoparathyroidism, will be presented at ECE in May, and CARES, our phase III program around selamimab in light chain amyloidosis patients, will be presented at ASCO in June. These presentations mark important milestone in bringing new therapeutic option to people living with rare diseases. With that, please advance to the next slide, and I will hand back to Pascal.
Thank you, Marc. Next slide, please. We are off to a strong start with four meaningful programs readouts already delivered in 2026 and a risk-rich catalyst path across the rest of the year. As shown here, the volume of high-value readouts for the year is notable, collectively pointing to a risk-adjusted peak year revenue potential exceeding $10 billion, supporting growth of the company to 2030 and well beyond. Next slide, please. As you can see, our recent R&D success is resulting in an extremely eventful year in 2026. We're excited to showcase our positive data from several programs at upcoming congresses, including ASCO and ADA. We're also expecting a significant wave of approvals, including the potential first approval of four NMEs and four lifecycle management indication.
We also look forward to additional regulatory decisions in major markets to continue to bring our medicines to more patients across the globe. Next slide, please. In closing, Q1 delivered strong commercial momentum and excellent pipeline execution, reinforcing our growing confidence in achieving our 2030 ambition. With a broad portfolio, a deep pipeline, and meaningful advances across multiple transformative technologies, we are well-positioned to extend growth beyond 2030. With that, please advance to the next slide, and we will move to the Q&A. As Joris mentioned at the start of the call, and we will see if he's more successful than his predecessor, Andy, please limit the number of questions you ask to allow others a fair chance to participate. Please use the raise hand function on Zoom.
Now let's move to the first question, which is from Richard Vosser at JPM. Over to you, Richard.
Thanks, Pascal. Two questions, please. First question on Tozorakimab. Could you characterize how you see the product profile relative to Dupixent and Nucala? Do you think the breadth of activity sufficiently differentiates the product so physicians wouldn't need to test for eosinophils anymore? A second question, just on the ramp of Enhertu. Could you just give us a bit of color around the DB-09 rollout and how we should think about the pace of uptake for the adjuvant setting and neoadjuvant setting and DB-11, DB-05? Thanks very much.
Thanks, Richard. Joris didn't go very far, right? You failed on the first step. Who is going to take the tozo? Sharon, do you want to take this? Ruud, if you have anything you want to add later.
Sure, I'm happy to. As you know, we announced the positive high-level results for Tozorakimab in OBERON and TITANIA and MIRANDA. In these phase III studies, we were able to demonstrate that we had a statistically significant, and in the case of OBERON and TITANIA, highly clinically meaningful result, both in the primary and in the overall population. Our primary population was former smokers. Our overall population included former and current smokers, patients across all blood eosinophil counts, and all stages of lung function severity. Now, we can't slice and dice those data until we present them at an upcoming medical meeting. We are encouraged by the data that we have seen, and we've characterized it as highly clinically meaningful in the case of OBERON and TITANIA, and we are moving at pace to submit that to regulators.
The only thing, Richard, I would like to add, regarding the potential is that the current biologics in COPD are primarily for high eosinophils. Their studies were done above 300. I think the uniqueness, as Sharon has shared, is that this is across the eosinophil count of patients.
Whether in the end of the day physicians wants to test in COPD, these neutrophil count is up to them. We are hoping for a very broad label on the basis of the OBERON and TITANIA data.
Yeah. I think really, of course, it's left up to physicians, but we think we have a true all-comers product from that viewpoint of EOS levels. Dave, do you want to take the HER2 question?
Yeah, absolutely. Thank you very much. At the highest level in HER2 with DB-09 clearly is bringing transformative benefit with PFS now exceeding 40 months. That has been very well-received in our promotional efforts that we've been engaging in. We're seeing encouraging early adoption across a broad frontline population, so utilization both in hormone receptor negative and hormone receptor-positive patients. We do, as you would expect, see academic HCPs are driving early adoption more so than you would see within the community within this Q1 post-launch. We will look forward to continuing to see our efforts in the community.
I think importantly, we are seeing increased recognition of the importance of continuing in HER2 treatment for a prolonged duration, with less consideration of this sort of maintenance notion, which I know was something that we had gotten some questions about coming out of ASCO. In terms of the early breast cancer studies with five and 11, I think they build really nicely on the existing confidence that exists within the HER2 positive space with three, nine, and now these studies. We've got upcoming PDUFA dates here shortly, and I think that there's a lot of energy around both of those studies and incorporating them into practice.
Thanks, Dave. Next question is from James Gordon at Barclays. Over to you, James. You may be on mute, James. We can't hear you.
Hello. Hopefully you can hear me now. James Gordon from Barclays. Thanks for taking the question. The question was on camizestrant for hormonal breast cancer and the route to this being a $5 billion plus product. I know you've got a couple of angles, but one is the SERENA-4 readout in the second half. On that one, to what extent does failure of Roche's PERSEVERA first line metastatic ESR1 all-comers trial mean you're more cautious on that readout? Are there important differences like maybe patient enrichment or the potency of your drug or other factors that mean you still think you've got a good shot at this, or is this quite a long shot based on PERSEVERA?
I know the other angle, probably the bigger angle, would be adjuvant hormonal breast cancer, which that could be a $20 billion+ category. I think your CAMBRIA-2 trial, which is like the analogous trial to lidERA that's already up for approval in Q4 for Roche, that's only meant to have final data in 2013. It's still recruiting. Is there a way you can still be a big winner here, or is it looking tougher?
Thanks, James. Susan.
Thanks for the question. In terms of the first-line metastatic hormone receptor-positive patient population, you know, obviously we'll have to wait and see the PERSEVERA data at ASCO. Remember that we've, you know, said that we do have a differentiated asset in Camizestrant. The effect size that we saw in the second-line setting was robust in both the ESR mutant and wild type. We also have enriched the first-line patient population to hopefully enrich for a greater endocrine sensitive population. One key differentiation as well from the PERSEVERA study for SERENA-4 is it's a much larger patient population. We sized for an effect size that will still be clinically meaningful in that population.
That's why I think we need to look out for both what the safety and the efficacy data are for PERSEVERA at ASCO. Moving on to the adjuvant population. Just as a reminder, we have two adjuvant studies, CAMBRIA-1 and CAMBRIA-2. CAMBRIA one study takes the patient population that's already had two to five years of CDK4/6 inhibition. That's the, if you like, the prevalent patient population of ER positive. CAMBRIA-2 is in a setting that's more similar to lidERA, but is differentiated from lidERA 'cause it does allow for combination with CDK4/6 in the adjuvant setting.
Given the benefit that's been seen with CDK4/6 inhibitors in the adjuvant setting, there's an increasing demand from patients and treating physicians to treat with CDK4/6 in that setting. If you think about the combination of CAMBRIA-1 and CAMBRIA-2 together, I think we have the opportunity to get the largest share of the adjuvant patient population given that. The success of lidERA, I think, does show that first of all, there's positive proof of concept for the effect of these drugs in that setting. Given that we've got very good profile with Camizestrant, I think that builds confidence on our likelihood of success in those settings.
Thank you, Susan. Next question is from Sachin Jain at Bank of America. Over to you, Sachin.
Hi there. Thanks for my question. One topic, way newer in Cardio Transform and a question for both Sharon and Ruud. For Sharon, as we head into the phase III, could you just remind us of a few factors? Could you remind us of TAF and SGLT usage at baseline and whether you think that will complicate a cross-trial comparison versus the 30% benefit Amvuttra had in HELIOS-B? On the secondary TAF subgroup, are you powered to be statistically significant if you repeat the Amvuttra benefit? Just a quick one for Ruud. If you could just talk to the commercial relevance of both of those points, cross-trial benefit comparison and the secondary endpoint. Thank you.
Thanks, Sachin. Sharon, do you want to start?
Sure. Sachin, let me just clarify the question because there was a little bit of a skip. I think you were asking about the number or the rate of SGLT2 background therapy.
Two bits. Tafamidis and SGLT2 usage at baseline, and whether that complicates cross-trial versus.
Okay
Amvuttra 30% benefit, and then the secondary taf subgroup powering.
All right. No, we haven't disclosed the exact numbers there. Let me speak broadly about this. We always anticipated that the treatment landscape would evolve during the time that we're running the Cardio Transform study. We designed a large study to account for that. The baseline standard of care treatments, here you've included SGLT2 and tafamidis, so stabilizer and SGLT2, are expected to have an impact on the event rate. We previously extended our trial duration to account for that. If we look at the HELIOS-B study, the treatment effect with vutrisiran versus placebo looked very similar in trial participants who were on background tafamidis versus those who were not. While we think background therapy should have an effect on event rates, we don't expect the differences in background therapy to have an effect on the overall treatment benefit.
You also asked about secondary endpoints. As you know, we designed the secondary endpoints to evaluate different patient subsets, and one of those is patients on tafamidis versus those who are not. And if we are able to demonstrate statistical significance, and it depends on how far we go through the statistical analysis plan, we view this as the icing on the cake. Ruud, would you like to comment further?
Yeah, thank you so much. Regarding, let's say, the peak year sales, Sachin, we have indicated in 2024 during the investor day that we see this asset as a $5 billion plus asset. I think, of course, as always, it's incredibly important to hit the primary endpoint. The primary endpoint is different from the endpoint of in the Alnylam trials with Amvuttra. Of course, here we are talking about a change from baseline to a composite endpoint of cardiovascular death plus CV recurrent events up to 140 weeks. That in itself, I think, is a very important part of the differentiation of Wainua versus the competition. Now equally, as Sharon mentioned, every secondary we can hit will further differentiate our product from the competition.
Let's wait and see, but we remain highly excited about the prospects of this asset.
Thank you, Ruud. Steve Scala, TD Cowen. Steve, over to you. You might be on mute, Steve. Okay, we can't hear Steve, so we'll come back to Steve in a minute. Maybe we move to Graham Parry at Citi.
Great. Thanks, taking my question. It's one on Tozorakimab again. Just wondering if we, you can confirm that we should interpret the way the headline press release was worded and your comments today to mean that the effect size across the different eosinophil groups is consistent across those groups. I think you talked just now about, potentially having a broad label, that would be the interpretation. Secondly, could you just give some sort of clarity as to what you think the implication of PROSPERO missing is and perhaps some rationale as to how you could have such highly clinically meaningful data in the MIRANDA and Oberon trials, without missing on the endpoint on PROSPERO. Thank you.
I hope, Sharon, you got the second question because the line broke up a bit. On the first one, I can quickly answer. We expect, we hope, and our expectation is we will get a broad label including all EOS level, but we can't today disclose the results in each group. You will see this when we present the data. The second question, PROSPERO, Sharon, hopefully you got it in full.
Yeah, I did hear the question. I'll just repeat that PROSPERO was the long-term extension study and that PROSPERO was unique from Oberon, TITANIA, and MIRANDA in that it had a different primary endpoint. It looked specifically at severe COPD exacerbations, those that cause hospitalization and death over the duration of 104 weeks. We really look forward to sharing the data. This will be a component of our regulatory package. We are really delighted with the overall data that we've seen across the LUNA program. PROSPERO supports the clinical profile of Tozorakimab, and we look forward to submitting our data in totality to the regulators as quickly as possible.
Thank you, Sharon. Next question is with Sarita Kapila at Morgan Stanley. Sarita, over to you.
Thanks for taking my questions. You've had a number of successes for Datroway across lung and breast cancer, as you've outlined. How should we now think about the totality of the commercial opportunity? Are you confident in reaching multi-billion peak sales for Datroway, excluding Enhertu? Just a quick one on efzimfotase alfa. How has the initial dialogue with the FDA been? Is there scope for approval in the subgroup of adolescents and adults with pediatric onset? Perhaps you could quantify what percentage or how large this population is. Thank you.
Thank you. I think maybe Dave, you can take the second one. The first one, second one's for you, Marc. If you, Sarita, if you go back to the script, I mean, maybe Marc can repeat it. Marc gave the split of the various groups, pediatric onset, adult and adult onset. The first question, Dave, do you want to go?
Yeah, Sarita, I think that the best way to address this is that when we laid out a $5 billion+ Ambition on Datroway, we continue to see the opportunity being just that. We've got a series of really important readouts that are gonna be happening over the course of the next several quarters. Obviously we've got AVANZAR, TL07, TL08, but also we've got TROPION-Lung 15, and then that'll be followed afterwards by TROPION-Lung 14 in a series of Dato studies incorporating with next wave IO. We've got quite a few programs underway. Lung cancer is obviously an important element of this. The work that we've done on QCS we think has positioned us well to be able to have multiple shots on goal within the AVANZAR study, and we're confident in the forecasts that we've got at this time.
Yeah, it's important to really keep in mind our view hasn't changed about the potential of this agent since the time when Dave talked about it back a little while ago. Of course, all these studies have to work, in particular AVANZAR, but our view hasn't changed. Marc, do you want to cover the second one?
Yes. Maybe I take the second question first. The in my prepared remarks, I had indicated that the pediatric cases are about 20%. The adult with pediatric onset would be 60%, and then the remaining 20% are covered by adult with adult onset. This is basically the breakdown of the populations suffering from HPP. In terms of data, as I've explained, we have three clinical trials, which we are going to submit to authorities. The first two are on the pediatric population, and the third one is on adolescent and adults with as a primary endpoint, six-minute walk test. There are many other endpoint which are measured in this trial, and we have concluded that this study is clinically meaningful and therefore we are going to submit this data to the regulators.
Thank you, Marc. Rajan Sharma, Goldman Sachs. Over to you, Rajan.
Hi, thanks for taking the question. Just a couple more on Datroway. Just wanted to understand the rationale for adding the QCS biomarker primary endpoint to TL07 and then also including it in TL08. Does this increase the probability of success of the trials in your view, or is it more about building a moat around the potential patient opportunity given that you have the biomarker? Related to that, is there any reason why control arms across these Datroway lung trials, including AVANZAR, may perform better or worse than you expected in a QCS positive population specifically? Thank you.
Thanks for the question. In terms of the rationale for including the biomarker in TL07, it's similar to the rationale for including it in AVANZAR. Based on the totality of data that we've seen so far across multiple data sets, we've seen consistent improvement in performance for both PFS and OS in the biomarker positive patient population, both as monotherapy and in combination with IO in a first line setting. That's the logic that says that, you know, it makes sense to include in TL07 as well. As we did with AVANZAR, our colleagues at Daiichi Sankyo went and approached the regulatory authorities and had discussion about this approach.
Similar for TL07, similarly to AVANZAR, there's an opportunity in the ITT and in the biomarker positive patient population in TL07, which as a reminder is in the PD-L1, less than 50% of the patient population. I think I've mentioned previously that for TL08, which is in the greater than 50% patient population, given that that's a smaller segment already, you know, the numbers that are accrued in that trial means that it makes sense to only include that as a secondary endpoint and not part of the primary analysis. Of course, assuming that AVANZAR does show an improvement in the biomarker positive, of course, you know, everybody including regulators will want to know what the performance is in the biomarker positive patient population.
I hope that addresses your question about why we're doing it in TL07 and TL08 and why it's different in the statistical analysis in TL07 versus TL08. In terms of your question about event rate, the event rates for these trials are determined by the event rate in the overall ITT patient population. While it's possible that the patient population that's biomarker positive has a different event rate, that isn't what determines the cut point. It's really the event rate in the overall population that's determining when we can do the data cutoff and therefore report the results.
We have no way to predict how the control arm will behave, right? They have to wait for the end of the study. The next caller, next question is Michael Leuchten, over to you. At Jefferies, over to you.
Thank you. One question maybe two on the delay. You've got a TL07 delay, just linking back to the last questions because of the implementation of QCS. Just wondering if you could talk to how complicated it is to run the test over existing tissue samples and whether that could slip any further or whether that's, say, a firm view and a readout. Then a question on [surovatamig], the depleter. There's also the delay here. What's driving that, please?
The timing of the results for TL07 are just based on the requirements for implementation of the biomarker within the clinical trial. That obviously requires an amendment, and there's other aspects of that. We have to actually sort of run the analyses on the samples that are available. There's no further delay to the event rate on TL07.
Maybe Michael also just, one of the maybe questions that's embedded within your question, gets to the commercial readiness, and how we think about testing in a post-approval world. We've been working really diligently to set up and be ready for QCS across the globe through a combination of central labs, but also decentralized testing work that we're doing. There's a lot of enthusiasm across regions to incorporate computational pathology into the way in which care is being delivered. It also gets to the previous question that Rajan asked. I mean, in many respects, you incorporate QCS into these programs because if it works and truly helps select patients, it's very differentiated for the program.
Yeah. It's a really important point, and we've made that point before. Maybe just to remind you know, if you assume that the ITT population will be positive, it's possible to assume that the QCS population might be even more positive in the positive scenario of all, of course. In the U.S., we would expect ITT use everywhere. In some countries where payers are more difficult and QCS gives us another chance to get a reimbursement if we cannot achieve it in the ITT population. It's really, you know, we have two shots on goal in term of reimbursement. Next question is Matthew Weston.
Can I speak on.
Speak on. Sorry
First of all, the just remind you that clarithromycin is not an event-based trial, but a time-bound trial. As a trial recruited faster than we expected, in order to reach the target medium exposure of the trial, we decided to extend the study by six months. It's not an event-based, but we wanted to return to the targeted medium exposure.
Thank you, Marc. Matthew Weston at UBS.
Thank you, Pascal. Two questions please, if I can, on eplontersen. The first is now that tafamidis generics are delayed to 2031, if the combo is superior in Cardio Transform, is it realistic to expect reimbursement of a double-branded regimen in that setting? The second question is around Wainua in ATTR-PN. One of your other differentiations potentially is gonna be the home administration claim in the U.S. Can you update us on the commercial performance in the U.S. market in the PN setting so we can understand how advantageous home administration really is?
Yeah. Thank you. Thank you, Matthew, for both questions. First of all, regarding the combination, of course, it fully depends, in my view and our view, on the size of the effect. If the effect size is very, very substantial, I truly believe that payers, certainly in the United States, will be open to reimburse both branded products for this debilitating disease. Let's not forget that the mortality rate of patients with ATTR-CM is very high. Once again, if the trial is going to show a very substantial benefit for the combination, I believe that the payers, the reimbursement authorities will certainly consider this for in order to reimburse it. Regarding the PN indication, I think overall we are quite happy how it goes.
It's very encouraging. There are a lot of patients with a so-called mixed phenotype, certainly in the U.S. Of course, with the registration of the competitor also in the CM trial, that's not always to capture all those patients. If you look at pure PN patients, we are clearly leading the pack here. You are mentioning the home administration. For many patients, that's an ideal way in order to get the medicine because there's no need to go at least four times a year to a hospital in order to get the drug administered by the physician.
I think the combination of a higher quality of life or a better quality of life, home administration, and a very strong efficacy in general, I think is one of the reasons we see a very strong uptake in the United States and in other countries for the PN indication.
Thank you, Ruud. Peter Verdult at Exane.
Hello, can you hear me?
Yeah, go ahead.
Sorry, Pascal. Peter Verdult here from BNP Paribas. Just Sharon and Ruud, could we come back to Tozorakimab really? Sorry to labor the point, but just coming at a different angle. Just wanted to explore maybe potential upside scenarios to your $3 billion-$5 billion peak sales assumption. Are you assuming that you will see IL-33 competition or competitors eventually making it to the market when you provide that peak sales target? Do you have any plans to explore Tozorakimab beyond COPD or lower tract respiratory disease? I'm thinking maybe nasal polyps or bronchiectasis. Just a quick clarification, Sharon, just on the PROSPERO question earlier. Am I right in thinking that the endpoint there was a bit different to OBERON and TITANIA? Thank you.
Thank you, Peter. Sharon, do you want to start with the second one?
Ruud, you can cover the first one.
Sure, yeah. You're spot on. The endpoint for PROSPERO was different than for OBERON and TITANIA. In PROSPERO, we specifically looked at selectively severe exacerbations, which is different than TITANIA that looked at moderate to severe exacerbations. The overall trial population that we enrolled in our comprehensive LUNA program is different from what competitor molecules did, and it really provides us with a point of differentiation for Tozorakimab. We have a differentiated molecule in terms of its bifunctional inhibition, and we also have a differentiated clinical trial program. Ruud, would you like to take the rest?
Yeah, of course. First of all, Peter, we have indicated once again that this product in our view is a $3 billion-$5 billion opportunity in COPD alone. Of course the competitive environment has changed somewhat, and we don't know exactly what they are going to do moving forward. Having said that, based on results of course, we are also thinking about potential other indications. You are mentioning bronchiectasis, potentially asthma. We haven't taken any decision yet on that. If everything moves well, of course we will have a look, but it makes sense also to move Tozorakimab in other indications where there's still a high medical need. On top of that, overall the biopenetration of the current biologics in COPD is still relatively limited.
It is below the 10%. It also shows the potential in COPD, which is a very heterogeneous disease, in order to use a complete new biologic specifically designed for COPD in order to capture the full potential in COPD.
Thank you, Ruud.
Thank you.
Christopher. Oh, sorry Peter, did you want to say something?
I just want to say thank you. Thanks, Pascal.
All right, cool. Christopher Lyrhem at SEB.
Yes. Thank you for taking my questions. My first is on MFN if you wouldn't mind commenting. How are you forecasting the future impact, let's say across the seven major markets, or how would you recommend we do it, perhaps is the question you'll answer. Then, is this for should we be thinking about it applying to only future launches as some of the competitors have said? Then on IL-5, we've got a competing long-acting IL-5 that's launched and tracking rapid growth. Ruud, what are you seeing on the competition?
What are your thoughts then, on the long-term future, I guess that part's for Sharon, of the role of IL-5 in the R&I therapeutic area, and how are you working to adapt to play a key part in that, going forward? Thank you.
Yeah. Let me take the first one, or the second one, sorry, the IL-5. Yeah, first of all, we are very pleased with the performance now for quite some time. Of Fasenra, it's clearly the leading anti-IL-5 in the class. I think the EGPA launch in countries like Japan, United States, have been very successful. Equally of course the class is changing somewhat. There's now long-acting anti-IL-5. Now having said that, the NIMBLE study was not specifically successful regarding the switch from Fasenra IL-5 to the long-acting one. It was even getting worse. I think what we need to do is to cement our position as the leading IL-5. I think the molecule is doing extremely well.
I think the mode of action, we sometimes forget that, is fundamentally different from other anti-IL-5s. We are depleting using the fills, and we have seen very strong traction across the world, and there's no reason to believe that that will not continue. Last but not least, what I said in my prepared marks, we have just launched Fasenra in China. China, there's a high medical need, and the potential of Fasenra in China is very substantial as well.
Sure. Building on that, Ruud, I'll just restate that we have a lot of faith in Fasenra. It's a fantastic molecule. It provides targeted, complete, and fast sustained eosinophil removal, effectively treating eos inflammation and reducing the risk for patients. We've got a winner in Fasenra. We have an eight week dosing regimen that delivers that sustained control and really stands out for its high adherence. We've got about 80%-90% of patients remaining on Fasenra through our pivotal studies, which is really remarkable, as well as in our real world studies, and it remains the only biologic with clinical evidence proven to reduce for both oral and inhaled background therapy. We've got a strong molecule there. As we think about future growth in the portfolio, building on our success in Fasenra is part of our early strategy.
I won't comment further on molecules that sit in our discovery pipeline. We think about how to continue to leverage the success that we've seen in this program.
The first question, you can take a very conservative approach and remove the 7+, the G7+, G7 being six countries and two, from the forecast if you want a very conservative approach. Knowing that the last two are smaller markets. We are working very hard, not only we but the whole industry, to improve the access and pricing environment in all of those countries. I should remind you all that it's only for new products, future new products. It will also be different, you know, product by product, country by country, in terms of what is the gap between the GDP per capita adjusted price in that country versus the U.S. Ultimately our goal is to launch those products in every single market and improve the access environment.
We have time to do this because new products will not be launched immediately. You've seen some movements in the U.K. already. Discussions based on the 301 Investigation will start with other countries, I think in the next few weeks or months. We are ourselves and the whole industry talking to countries and explaining the importance of improved access, not only for patients, but also for investments in R&D and, in particular, in R&D in their respective countries. You know, we are getting a positive response in some countries and, you know, more wait and see in other countries. You know, we have it. This is going to play out over the next 18 months, two years. We have time to hopefully reshape the environment.
You know, I've given you the most conservative approach in terms of forecasting, but I don't think it's going to be like this. You know, as it is today, you have to remember the whole of Europe represents 20% of our global sales. Take a fragment out of this. This is not huge. We truly hope we are going to get better pricing and better access and be able to launch our products everywhere, which is, of course, the ultimate goal. Seamus Fernandez, Guggenheim.
Thanks, Pascal. Our question is actually on the positioning of the GLP-1 and how you're thinking about that. You know, can you maybe just walk us through how the upcoming ADA is really going to help us fully de-risk your strategy in this space? Maybe help us understand the safety supporting the aggressive advancement into phase III. Maybe if you could just specifically comment on whether these data are likely to convince investors that product half-life is key to differentiation on tolerability over and above planned titration scheme. Just trying to get an understanding of how these data coming at ADA are really going to wrap around the very broad phase III program that you've initiated. Thanks so much.
Yeah, thank you, Seamus. This one is for Sharon, and maybe, Ruud.
Yep
You can also jump in. I just want to, you know, be clear, fully de-risk is a bit ambitious. We will fully de-risk when we are at the end of the phase III program where we are moving as fast as we can into phase III. Over to you, Sharon.
Yeah, thank you for the question, Seamus. As you know, those data are upcoming at ADA in June, so I cannot tell you what the data say. The conference organizers would frown on that. We did announce that we completed the phase II-B trials for eleglipron, and that the data that we saw in those phase II-B trials, one for obesity and one for patients with type two diabetes, gave us the confidence that we need to move into a very comprehensive phase III development program. We have dual goals there. We're looking at both weight loss efficacy, and we're also looking at outcome benefits, which are key drivers for us because we are focused not solely on weight loss, but on being able to address complex interrelated comorbidities. AstraZeneca is in a unique position with our broad portfolio.
We are ideally suited to creating both monotherapies and fixed-dose combinations with eleglipron that allow us to address comorbid disease. At ADA, we look forward to sharing the data and continuing this conversation. What we saw in those data gave us the confidence that we needed to fully invest in our comprehensive program.
No, there's not a lot to add of what Sharon has said. I think that the focus on outcomes, I think our strength is with fixed-dose combinations, and we have articulated a few of those potential combinations, and one of them is clearly with our SGLT2 Farxiga. Last but not least, I think also AstraZeneca is quite uniquely positioned regarding our global footprint. We have a very strong presence, as we all know, in the international markets, and there's still an incredible high unmet medical need in those markets regarding obesity treatment, but clearly also diabetes.
We're going to add that the we have a very ambitious phase III program that is excellent, really. The team has done an amazing job. We have a very, very strong data set, assuming, of course, the studies are positive, which we believe we have a good chance for that, of course. We will have a very strong set of data across a very broad phase III program to launch this product. Next question is from Luisa Hector at Berenberg. Over to you, Luisa.
Thank you, Pascal. A couple, please. On Camizestrant, are there interim analyses still pending for the CAMBRIA or even SERENA-4 Given that we've had some discussion on phase III trials, which are in flight, but you've been making some changes such as TL07, TL08, I wonder whether you could give us some more color around your work with the FDA on real-time clinical trials. I see AstraZeneca mentioned as one of two companies working with the FDA there. What kind of benefits could this ultimately bring in terms of timing and savings? Thank you.
I think, Susan, this for you. It's a question is really a real-time collaboration, study collaboration with the FDA.
Yeah, sure. Thanks for the question, Luisa. For interim analyses, you know we don't comment on those, so I can't really address that question anymore. For the real-time clinical trials, I think this is an exciting first step towards this future. The trial that we're collaborating with the FDA on is the Traverse trial, which is with a, with a, you know, well-established medicine, capivasertib, in a mantle cell lymphoma setting. You know, what this enables us to do is literally to, you know, as the adverse events and the things come in, we'll get notified simultaneously with the FDA. I think this will enable us to have learnings.
I think the opportunity, though, is in a future world, where you're not submitting based on documents, but you are submitting based on access to data. This could save time, in terms of preparation for submissions, and also time from the regulatory side in review of those submissions, because the various analyses can be done. You can spend more time on the discussions with the agency about the context and the relevance of the data and the impact that that's going to have on treatment outcomes. The hope is that this will lay the groundwork for that collaboration, and we're very happy to be partnering with the FDA in that regard and at the forefront of learning here.
Thank you, Susan . Maybe we could try again Steve Scala. If Steve is back. Can you hear me, Steve? Okay, he's given up or he has technical difficulties. Let's move to Mattias Häggblom at Handelsbanken. Mattias, over to you.
Thanks so much. Mattias here from Handelsbanken. One question, please. Can you talk about CAR T and specifically how we feel about the Gracell BCMA CAR T program, but also Gracell's FasTCAR as a platform in light of industry's rapidly growing interest?
The line was not very good, Mattias, but hopefully Susan you got it. It's about AZD0120, but I'm not sure that.
Yeah
you can repeat the question.
I think I just want to clarify the question a little bit. I think you were asking about how the FasTCAR process helps the differentiation of AZD0120, the lead product. Did I get that right? I can't hear the answer. I'll answer what I thought the question was.
One of the differentiations of AZD0120 is that it's developed with this FasTCAR process, which enables the ex vivo growth of the cells in a three day process, which means that you can get a turnaround time reliably in around a 16-day timeframe because after the cells have been produced, there's still some quality testing that needs to be done before the cells are shipped to the patient. That reliable and shorter delivery time is really important for sites and for the operationalization. There are other factors that are involved in here as well.
You end up giving a lower dose, and you give a lower dose of fitter T-cells than it can then expand in the patient's body in vivo, more rapidly. What that also delivers is a predictable time of onset of any cytokine release syndrome and enable it to be positioned as a potentially outpatient treatment, because people that, you know what the timing of the cytokine release syndrome is can be prepared for that. Then the patient can go back after that period of time. You know, it's not just the FasTCAR process in itself. It also is the, you know, the dose that you end up with and the timing of the CRS that also make it differentiated.
I think the other factor, of course, is that it's a dual CAR. It's got CD19 and BCMA targeting. We think that's important for avoidance of the escape mechanisms from downregulation of one target or the other. Overall, we're delighted with the profile that we've got with AZD0120. It was presented in detail at the ASH meeting. We now have ongoing Durga4 study in phase III study in later line multiple myeloma. You'll see further studies in the coming months as we open up this program more broadly.
Thank you, Susan. The next question is from Simon Baker, Redburn. Over to you, Simon.
Thank you, Pascal. Just one from me, if I may, please, for Dave. I was wondering if you could give us an idea of the underlying demand growth for Tagrisso. As you said, it was distorted by wholesaler destocking. Related to that, is that wholesaler destocking specific to Tagrisso, or are you seeing that anywhere else in the portfolio? Thanks so much.
Thanks, Simon, for the question. Just within the U.S., we have really seen Tagrisso with strong frontline leadership. Just to build and quantify some of the comments that I made in the prepared remarks, the demand growth for the quarter for Tagrisso was mid-teens%. You can see that the really truly on a higher than historical destocking levels is what brought the net results down to where they were. Specific to your question, we have seen some suggestion of this on other orals, but it didn't include Calquence. That could be because of a buildup for AMPLIFY. Not entirely sure, but we are seeing some destocking across the oral agents that's taking place. It was particularly noteworthy on Tagrisso.
I think the most important piece, though, is that I don't see that going any further down. The demand growth is very strong. We're seeing a clear preference for FLAURA2. Very importantly on MARIPOSA, we have not seen any impact from the subcutaneous launch on U.S. Tagrisso shares. The subcutaneous launch is cannibalizing IV, but it is not having impact on Tagrisso shares, and by the way, that same is true in Germany and in Japan.
Thank you, Dave. The last question is Justin Smith at Bernstein. Over to you, Justin.
Yeah, thank you, Pascal. I've got one for Ruud. Ruud, if I remember correctly, during the August call last year, post ESC, Baxdrostat, you said it could be above $5 billion, it could be above $10 billion, time would tell. Just wondered over six months on for that, if those remarks are the same or if you would qualify those remarks at all.
Yeah, no, I think that they are still, the, the same. Once again, what we have indicated during the Investor Day that this is potentially a $5 billion asset. Let's not forget that we're investigating. The $5 billion is built roughly half of that is in the fixed-dose combination. That study will read out beyond 2027. The other one is the mono components, we are also looking into CKD for Baxdrostat. There are four other indications which potentially, if successful, can move that number up to potentially $10 billion and that view hasn't changed at all.
Very good. Let's end on that, Justin. You're making Ruud nervous. We're moving into budget timing. Baxdrostat is definitely a big product, and we're all excited to see it launch in many countries very soon. Thank you, everybody. Thank you for your great questions and for your interest in our company, and we wish you a good rest of the day.